Quality Of Life Participation Research Articles

암 생존자의 삶의 질에 영향을 미치는 요인: 8기 국민건강영양조사 자료(2019년) 활용

Purpose: This study was conducted to identify the factors affecting the quality of life among cancer survivors using the results of the 8th National Health and Nutrition Survey. Methods: Data was collected from the KNHANES Ⅷ-1 (2019). The research tool used the demographic and health related characteristics and quality of life (EQ-5D). Among total 8110 participants, 262 cancer survivors were included in the analysis. Data analysis was conducted using SPSS 25 version. Results: The overall mean of quality of life for participants was 0.92±0.13 (range 0~1). There were statistically significant differences in the quality of life results by age (F=6.23, p<.001), marital status (F=7.40 p<.001), education level (F=12.36, p<.001), current economic activity (t=22.28, p<.001), household income (F=5.49, p=.001), cancer type (t=2.61 p=.018), chronic disease (t=21.29, p<.001), health examination (t=5.39, p=.021), cancer screening (t=4.93, p=.027), activity limitation (t=63.93, p<.001), physical activity (F=4.96, p=.008), monthly drinking (t=8.39, p=.004), depressive symptoms (t=13.52, p<.001), private health insurance (t=20.15, p<.001), body mass index (r=-.17 p=.005), subjective health status (r=.42 p<.001), perceived stress level (r=-.18 p=.003). Factors influencing the quality of life of cancer survivors included cancer screening (β=.21, p=003), education level (β=-.22, p=.003), current economic activity (β=.18, p=.010), subjective health status (β=.19, p=.007), depressive symptoms (β=-.15, p=.034), and physical activity (β=.14, p=.037), which explained 24.5% of the quality of life. Conclusion: To improve the quality of life of cancer survivors, the appropriate intervention is needed for effective management considering various factors which affect the quality of life of the cancer survivors.

INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial

BackgroundEarly pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4).MethodsA multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression.DiscussionINTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke.Trial registrationClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.

Memory advocate peers: Piloting a sustainable, replicable, volunteer peer mentor program to support individuals newly diagnosed with dementia and their care partners

AbstractBackgroundAlzheimer’s disease and related dementias (ADRD) have an enormous impact on persons living with dementia and their care partners. Care partners of people with dementia are more likely to have depression, anxiety, and be isolated, heightened by events like the COVID‐19 pandemic. Connecting individuals to research has been challenging, especially in diverse populations who are disproportionately impacted by ADRD and health and socioeconomic inequities. The Memory Advocate Peers (MAP) Program aims to address these challenges by building and piloting a sustainable, replicable, volunteer peer mentor program to support individuals newly diagnosed with dementia and their care partners, and help to connect them to services.MethodThe MAP program has been developed and is led by people living with dementia, care partners, community‐based experts in dementia care, and healthcare leaders. The program will give people with dementia and care partners the opportunity to share experiences with a volunteer advocate who has lived experience with dementia, obtain valuable education about how to live well with dementia, connect to community services, and access clinical trials or other research opportunities. Partnerships have been established with New York University‐affiliated neurologists to identify and refer newly diagnosed patients to the program, and with the leading local research programs.ResultMAP will recruit and train up to 25 advocates to provide twelve months of post‐diagnostic support to 50 clients and care partners (where applicable), with a focus on under‐represented communities. A research study is embedded within the program to evaluate feasibility, as well as participant quality of life, health resource use, impact on psychological wellbeing, and value of research participation.ConclusionThis pilot will be critical in understanding the impact peer‐to‐peer mentorship can have for both the individual with ADRD and the care partner. It will also be critical to develop best practices to recruit, train and support volunteers serving as these peer advocates. Results from the pilot will be used to improve the program prior to expansion to other regions.

Effectiveness of technology-based psychosocial interventions on diabetes distress and health-relevant outcomes among type 2 diabetes mellitus: A systematic review and meta-analysis

Background Poor management of type 2 diabetes mellitus may affect individuals’ physical and emotional health. Access to ongoing psychosocial interventions through technological platforms may potentially minimise diabetes complications and improve health-related outcomes. However, little is known about the effectiveness of such interventions on diabetes distress and health-related outcomes. Objective To synthesise the best available evidence concerning the effectiveness of technology-based psychosocial interventions on diabetes distress, self-efficacy, health-related quality of life, and HbA1c level in adults with type 2 diabetes mellitus. Methods A search of eleven databases was conducted to identify randomised controlled trials that examined the effects of technology-based psychosocial interventions on the outcomes. Randomised controlled trials reported in English from 2010 to 2020 were included. Selection of studies, quality appraisal, and data extraction were conducted by two reviewers independently. Meta-analyses, subgroup analyses and sensitivity analysis were performed using Review Manager. Intervention effects was measured using standardise mean difference. Results Twenty randomised controlled trials fulfilled the eligibility criteria and 18 randomised controlled trials were included in meta-analysis. technology-based psychosocial interventions improved diabetes distress, self-efficacy and HbA1c levels with significant and small effect sizes. Subgroup analyses revealed greater improvement in health-related quality of life for participants with comorbid depression and lower HbA1c levels for studies with lesser than 100 participants. Conclusion The findings of this review increase knowledge on the effectiveness of technology-based psychosocial interventions on diabetes distress and self-efficacy. However, evidence to support the effects of technology-based psychosocial interventions on HbA1c and health-related quality of life was not strong. More research is needed to examine the effectiveness of the psychosocial interventions delivered through mobile applications or virtual reality.

PRELIMINARY ESTIMATES OF OFF-TREATMENT DURABILITY OF GEFAPIXANT ACROSS TWO PHASE 3 STUDIES OF PARTICIPANTS WITH REFRACTORY OR UNEXPLAINED CHRONIC COUGH

TOPIC: Respiratory Care TYPE: Original Investigations PURPOSE: In two phase 3, randomized, placebo-controlled trials (COUGH-1, NCT03449134; COUGH‑2, NCT03449147), 52 weeks of twice-daily (BID) treatment with gefapixant 45 mg, a P2X3-receptor antagonist, significantly reduced patient-reported cough severity and improved cough-related quality of life in participants with refractory or unexplained chronic cough (RCC and UCC, respectively). This exploratory, observational study in a subset of participants from COUGH-1 and COUGH-2 evaluated the 3-month off-treatment durability of gefapixant in participants with a treatment response after 1 year of treatment. METHODS: Participants from a subset of study sites in select countries who completed 1 year of treatment in COUGH-1 or COUGH-2 and were ≥80% compliant with the completion of patient-reported outcome entries and ≥80% adherent to study intervention through the main and extension study periods were eligible. Responders at 52 weeks from baseline were defined as those who achieved a ≥30-mm reduction on the cough severity visual analog scale (VAS), a ≥1.3-point increase on the Leicester Cough Questionnaire (LCQ), or a ≥1.3- or ≥2.7-point reduction on the Cough Severity Diary (CSD). Treatment durability was assessed as the proportion of responders in each treatment group (ie, placebo, gefapixant 15 mg BID, or gefapixant 45 mg BID) after the 3-month off-treatment phase (Week 64). RESULTS: Of 163 participants enrolled in the off-treatment study, 58, 55, and 50 had received placebo, gefapixant 15 mg, or gefapixant 45 mg, respectively, in COUGH-1 or COUGH-2. Participant characteristics were generally comparable with the overall study population and across intervention groups. At Week 52, 52%, 43%, and 74% of participants were VAS responders in the placebo, gefapixant 15 mg, and gefapixant 45 mg groups, respectively, with 91%, 67%, and 86% of responders demonstrating a response at Week 64. At Week 52, 63%, 83%, and 81% of participants were LCQ responders, respectively, with 88%, 87%, and 80% of responders demonstrating a response at Week 64. For the CSD cutoff of ≥1.3-point reduction from baseline, 67%, 77%, and 91% of participants were responders at Week 52, respectively, with 93%, 78%, and 92% of responders demonstrating a response at Week 64. For the CSD cutoff of ≥2.7-point reduction, 44%, 43%, and 79% of participants were responders at Week 52, respectively, with 90%, 80%, and 71% of responders demonstrating a response at Week 64. CONCLUSIONS: A high proportion of participants with RCC or UCC who demonstrated a treatment response after 52 weeks of study intervention demonstrated a response after a 3-month off-treatment period, with consistent results across VAS, LCQ, and CSD outcomes. CLINICAL IMPLICATIONS: This exploratory study suggests treatment with gefapixant 45 mg for 52 weeks may result in some durability of treatment effect. Further data will help inform durability after treatment cessation. DISCLOSURES: Advisory Committee Member relationship with Merck Please note: $1001 - $5000 by Surinder Birring, source=Web Response, value=Consulting fee Consultant relationship with Merck Please note: 2017-2021 Added 04/28/2021 by Peter Dicpinigaitis, source=Web Response, value=Consulting fee Employee No relevant relationships by Lorcan McGarvey, source=Web Response Advisory Committee Member relationship with Merck Please note: $5001 - $20000 by Alyn Morice, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Bellus Please note: $5001 - $20000 by Alyn Morice, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Bayer Please note: $5001 - $20000 by Alyn Morice, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Sanofi Please note: $5001 - $20000 by Alyn Morice, source=Web Response, value=Consulting fee Employee relationship with MSD Please note: 11/2016 to current Added 05/06/2021 by David Muccino, source=Web Response, value=Salary Employee relationship with Merck Sharp & Dohme Corp. Please note: May 1995 - present Added 04/30/2021 by Allison Nguyen, source=Web Response, value=Salary Advisory Committee Member relationship with GSK Please note: $1001 - $5000 by Ian Pavord, source=Web Response, value=Consulting fee Employee relationship with Merck & Co., Inc. Please note: 7 years Added 04/30/2021 by Jonathan Schelfhout, source=Web Response, value=Salary Scientific Medical Advisor relationship with Merck Please note: $1001 - $5000 by Jaclyn Smith, source=Web Response, value=Consulting fee Scientific Medical Advisor relationship with Vitalograph Ltd Please note: $5001 - $20000 by Jaclyn Smith, source=Web Response, value=Grant/Research Support Grant Funding relationship with Merck Please note: 2020-2022 Added 05/01/2021 by Jaclyn Smith, source=Web Response, value=Grant/Research Support Employee relationship with Merck & Co, Inc Please note: 2019 to Present Added 04/30/2021 by Ping Xu, source=Web Response, value=Salary

Impact of kinesiophobia on physical function and quality of life in functional ankle instability individuals: an observational study

BackgroundFunctional ankle instability is a common musculoskeletal condition affecting the community. It is characterized by repetitive bouts of giving away, recurrent sprains, and sensation of instability leading to functional deficits in an individual. The present study aimed to assess the influence of kinesiophobia on physical function and quality of life in participants with functional ankle instability. A cross-sectional study was conducted in 30 participants with functional ankle instability. Kinesiophobia was assessed using the 17-item Tampa Scale of Kinesiophobia, physical function using the Foot and Ankle Ability Measure (FAAM) and the FAAM-Sport version (FAAM-S), and quality of life using SF-36.ResultsThe TSK score showed a moderate negative correlation with FAAM-S (r = −0.5, p = 0.005) and a weak negative correlation with SF-36 physical component summary (r = −0.42, p = 0.02). However, TSK showed no significant correlation with FAAM-ADL and SF-36 mental component summary.ConclusionIncreased fear of movement, reduced physical function, and health-related quality of life were observed in functional ankle instability individuals. Hence, evaluation of these parameters is imperative in these individuals.

Resilience as a predictor of quality of life in participants with borderline personality disorder before and after treatment

BackgroundStudies have suggested that psychotherapy improves the Quality of Life (QoL) of participants with Borderline Personality Disorder (BPD). However, there are no studies on the differential efficacy of treatments on the QoL of participants with BPD. Moreover, the relationship between QoL and resilience has rarely been studied in participants with BPD. Objectives: a) to examine whether people with BPD have worse QoL than the non-clinical population; b) to examine whether there are statistically significant differences between Dialectical Behavioural Therapy (DBT), Systems Training for Emotional Predictability and Problem Solving (STEPPS), or Cognitive Behavioural Therapy-Treatment at Usual (CBT-TAU) in the improvement of QoL; c) to examine whether participants show clinically significant improvements in QoL after treatment; d) to analyse whether resilience is associated with QoL before and after the BPD treatment; e) to analyse whether resilience is a predictor of QoL at pre-treatment and posttreatment.MethodThe sample comprised 403 participants (n = 202 participants diagnosed with BPD and n = 201 non-clinical). Participants filled out the Quality of Life Index, Resilience Scale, and Beck Depression Inventory. The clinical participants received one of these possible treatments, DBT, STEPPS, or CBT-TAU. MANOVA and regression analyses were performed.Resultsa) participants diagnosed with BPD had statistically significant lower resilience than the non-clinical population; b) all three forms of psychotherapy statistically improved QoL, but there were no statistically significant differences between DBT, STEPPS, and CBT-TAU in the improvement of QoL; c) participants did not show clinically significant improvements in QoL after treatment; d) resilience was associated with QoL before and after treatment; and e) resilience was a predictor of QoL before and after treatment.ConclusionIt is necessary to assess QoL and Resilience in studies on psychotherapy with BPD patients.

Targeting of antithrombin in hemophilia A or B with investigational siRNA therapeutic fitusiran—Results of the phase 1 inhibitor cohort

BackgroundFitusiran, an investigational small interfering RNA therapy, reduces antithrombin production to rebalance hemostasis in people with hemophilia A or B, with or without inhibitors. ObjectivesTo evaluate the safety and efficacy of fitusiran treatment for people with moderate/severe hemophilia A or B with inhibitors. Patients/MethodsIn this open‐label phase 1, part D study, 17 males with hemophilia A or B with inhibitors received three once‐monthly subcutaneous injections of fitusiran 50 mg (n = 6) or 80 mg (n = 11); followed for up to 112 days. Endpoints included safety (primary), pharmacokinetics/pharmacodynamics (secondary), annualized bleeding rate, and patient‐reported outcomes (exploratory). ResultsThe most common adverse event was injection site erythema (n = 8). No thrombotic events were reported. At nadir, mean (standard error of the mean [SEM]) antithrombin activity decreased from baseline by 82.0% (2.2) and 87.4% (0.7) in the 50 mg and 80 mg groups, respectively. Antithrombin reduction was associated with increased thrombin generation. 11/17 (64.7%) participants had no bleeds during the observation period (mean [standard deviation] 69.4 [16.3] days). Mean (SEM) changes from baseline in Haemophilia Quality of Life Questionnaire for Adults total (−9.2 [2.9]) and physical health (−12.3 [3.9]) domain scores suggested clinically meaningful improvement. ConclusionsMonthly fitusiran was generally well tolerated, lowered antithrombin levels from baseline, and resulted in improved thrombin generation. These preliminary results suggest that monthly fitusiran treatment may reduce bleeding episodes and improve quality of life in participants with hemophilia A or B with inhibitors.

Pain Intensity and Pain Interference in People With Progressive Multiple Sclerosis Compared With People With Relapsing-Remitting Multiple Sclerosis

ObjectiveTo describe pain intensity and interference in people with progressive multiple sclerosis (MS), compare these with people with relapsing-remitting multiple sclerosis (RRMS), and identify common and unique factors associated with pain intensity in people with progressive MS and RRMS. DesignObservational, cross-sectional analysis using baseline data from a longitudinal survey on quality of life in participants with MS. SettingCommunity. ParticipantsA total of 573 adults with MS (N=573; progressive MS, n=142; RRMS, n=431). InterventionsNot applicable. Main Outcome MeasuresAverage pain intensity was measured by an 11-point numeric rating scale, and pain interference was measured by the Patient-Reported Outcomes Measurement Information System Pain Interference Short Form. ResultsParticipants with progressive MS reported moderate average pain intensity (3.22±2.50) and elevated pain interference (T score of 55.55±9.13). They did not differ significantly from those with RRMS in average pain intensity or pain interference. Common factors associated with higher average pain intensity were more severe disability, lower education level, unemployment, and current smoking. In those with progressive MS, older age was associated with lower average pain intensity. ConclusionsPain intensity and interference are similar across MS types. In addition to assessing and treating pain, it is important to screen for modifiable pain-related factors, such as smoking cessation, in this population.

Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved in the United States and European Union for excessive daytime sleepiness in adults with narcolepsy (75-150 mg/day) or obstructive sleep apnea (OSA; 37.5-150 mg/day). In 12-week studies, solriamfetol was associated with improvements in quality of life in participants with narcolepsy or OSA. These analyses evaluated the long-term effects of solriamfetol on quality of life. Participants with narcolepsy or OSA who completed previous solriamfetol studies were eligible. A 2-week titration was followed by a maintenance phase ≤ 50 weeks (stable doses: 75, 150, or 300 mg/day). Quality of life assessments included Functional Outcomes of Sleep Questionnaire short version, Work Productivity and Activity Impairment Questionnaire: Specific Health Problem, and 36-Item Short Form Health Survey version 2. Mean (standard deviation) changes from baseline to end of study were evaluated. Data were summarized descriptively. Adverse events were assessed. Safety population comprised 643 participants (417 OSA, 226 narcolepsy). Solriamfetol improved Functional Outcomes of Sleep Questionnaire short version Total scores (mean change [standard deviation], 3.7 [3.0]) and 36-Item Short Form Health Survey version 2 Physical and Mental Component Summary scores (3.1 [6.9] and 4.3 [8.4], respectively); improvements were sustained throughout treatment. On Work Productivity and Activity Impairment Questionnaire: Specific Health Problem, solriamfetol reduced (improved) % presenteeism, % overall work impairment, and % activity impairment by a minimum of 25%. Common adverse events (≥ 5%): headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection. Long-term solriamfetol treatment was associated with clinically meaningful, sustained improvements in functional status, work productivity, and quality of life for up to 52 weeks. Adverse events were similar between narcolepsy and OSA. Registry: ClinicalTrials.gov; Name: A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or OSA; Identifier: NCT02348632; URL: https://clinicaltrials.gov/ct2/show/NCT02348632. Weaver TE, Pepin J-L, Schwab R, etal. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021;17(10):1995-2007.

Association between severity of hip chondrolabral injuries, dynamic hip muscle strength and quality of life: A cross-sectional study in patients with femoroacetabular impingement syndrome scheduled for hip arthroscopy

BackgroundWe assessed the association between: the severity of hip chondral or labral pathology with dynamic hip muscle strength or quality of life in patients with femoroacetabular impingement syndrome scheduled for hip arthroscopy. We also assessed the association between dynamic hip muscle strength with quality of life. MethodsEighty-three participants with femoroacetabular impingement syndrome scheduled for hip arthroscopy were included. We measured dynamic hip abduction and adduction muscle strength with an isokinetic dynamometer (Nm/kg), and quality of life with the iHoT-33 questionnaire. The severity of hip chondrolabral pathologies was scored using the modified Beck classification. Linear regression analyses were conducted to assess the association between severity of hip chondral or labral pathology with dynamic hip muscle strength and quality of life. FindingsThe regression analyses showed no association between the (i) severity of hip chondral (adjusted r2: 0.14) or labral (adjusted r2: 0.08) pathology and quality of life (P > 0.05), (ii) between the severity of hip chondral or labral pathology and dynamic hip abduction and adduction muscle strength (P > 0.05). Significant correlation was observed for quality of life and hip abduction (adjusted r2:0.29; P < 0.001) or adduction (adjusted r2: 0.32; P < 0.001) muscle strength. InterpretationThe severity of hip chondral or labral pathologies were not associated with quality of life or dynamic hip muscle strength in participants with femoroacetabular impingement syndrome. Greater dynamic hip abduction and adduction muscle strength were associated with better quality of life in participants with femoroacetabular impingement syndrome scheduled for hip arthroscopy.

Cryoablation for Palliation of Painful Bone Metastases: The MOTION Multicenter Study.

To assess the clinical effectiveness of cryoablation for palliation of painful bone metastases. MOTION (Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases) (ClinicalTrials.gov NCT02511678) was a multicenter, prospective, single-arm study of adults with metastatic bone disease who were not candidates for or had not benefited from standard therapy, that took place from February 2016 to March 2018. At baseline, participants rated their pain using the Brief Pain Inventory-Short Form (reference range from 0 to 10 points); those with moderate to severe pain, who had at least one metastatic candidate tumor for ablation, were included. The primary effectiveness endpoint was change in pain score from baseline to week 8. Participants were followed for 24 weeks after treatment. Statistical analyses included descriptive statistics and logistic regression to evaluate changes in pain score over the postprocedure follow-up period. A total of 66 participants (mean age, 60.8 years ± 14.3 [standard deviation]; 35 [53.0%] men) were enrolled and received cryoablation; 65 completed follow-up. Mean change in pain score from baseline to week 8 was -2.61 points (95% CI: -3.45, -1.78). Mean pain scores improved by 2 points at week 1 and reached clinically meaningful levels (more than a 2-point decrease) after week 8; scores continued to improve throughout follow-up. Quality of life improved, opioid doses were stabilized, and functional status was maintained over 6 months. Serious adverse events occurred in three participants. Cryoablation of metastatic bone tumors provided rapid and durable pain palliation, improved quality of life, and offered an alternative to opioids for pain control.Keywords: Ablation Techniques, Metastases, Pain Management, Radiation Therapy/OncologySupplemental material is available for this article.© RSNA, 2021.

Quality of Life: Changes in Self-Perception in People with down Syndrome as a Result of Being Part of a Football/Soccer Team. Self-Reports and External Reports.

The hypothesis posed was whether being part of a football/soccer team influenced the quality of life (QL) of the people who participated in it since their perception of themselves is enhanced by factors, such as self-determination, social inclusion, emotional well-being, physical well-being, material well-being, rights, personal development, and internal relationships. The objective was to evaluate the QL of people with Down Syndrome (DS) using their self-perception (n = 39) and the perception of the informants (family members, teachers) (n = 39). The KidsLife-Down Scale, with a few modifications, was used. In general, differences of opinion between the subgroups of participants with DS and informants showed that results were higher in terms of perception for participants in the DS subgroup. Scores for all variables were higher for those participants with DS who said they did engage in practicing competitive football/soccer. Although the perception of informants provides a great deal of information regarding the QL of participants with DS, participants with DS should also be involved in the evaluation process and their self-perceptions taken into account. It is not participating in a football team that causes the conclusions of the study, but training (which includes the friendly matches that are played), the cause correlated with the improvements detected in the athlete’s DS.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AimsSacral neuromodulation (SNM) is a guideline‐recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration‐approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN‐SNM study was designed to evaluate UUI participants treated with the Axonics System. Two‐year follow‐up results are presented.MethodsOne hundred and twenty‐nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3‐day voiding diaries, ICIQ‐OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post‐treatment. As‐treated and Completers analyses are presented.ResultsAt 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ‐OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device‐related adverse events occurred.ConclusionsAt 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant‐related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

Exercise efficacy and prescription during treatment for pancreatic ductal adenocarcinoma: a systematic review

BackgroundSurgical resection remains the only curative treatment for pancreatic cancer and is associated with significant post-operative morbidity and mortality. Patients eligible for surgery, increasingly receive neo-adjuvant therapy before surgery or adjuvant therapy afterward, inherently exposing them to toxicity. As such, optimizing physical function through exercise during treatment remains imperative to optimize quality of life either before surgery or during rehabilitation. However, current exercise efficacy and prescription in pancreatic cancer is unknown. Therefore, this study aims to summarise the published literature on exercise studies conducted in patients with pancreatic cancer undergoing treatment with a focus on determining the current prescription and progression patterns being used in this population.MethodsA systematic review of four databases identified studies evaluating the effects of exercise on aerobic fitness, muscle strength, physical function, body composition, fatigue and quality of life in participants with pancreatic cancer undergoing treatment, published up to 24 July 2020. Two reviewers independently reviewed and appraised the methodological quality of each study.ResultsTwelve studies with a total of 300 participants were included. Heterogeneity of the literature prevented meta-analysis. Exercise was associated with improvements in outcomes; however, study quality was variable with the majority of studies receiving a weak rating.ConclusionsHigh quality evidence regarding the efficacy and prescription of exercise in pancreatic cancer is lacking. Well-designed trials, which have received feedback and input from key stakeholders prior to implementation, are required to examine the impact of exercise in pancreatic cancer on key cancer related health outcomes.

Predictive factors of quality of life among the elderly in Iran: Application of Andersen's behavioral model.

BACKGROUND:This study aimed to identify the quality of life (QoL) and its predictive factors based on the Andersen's behavioral model among the elderly in Iran.MATERIALS AND METHODS:A quantitative cross-sectional study was conducted on 400 people aged 60+ resident in Zanjan, Iran, in 2019. Data were collected based on the Andersen's behavioral model constructs by the questionnaires. Path analysis was used to determine both direct and indirect effects of variables and also for estimating the values of coefficients in the underpinning linear model.RESULTS:In this study, 50% of the participants were female, and 83% were married. The participant's QoL was 37.4 (9.8). The results confirmed that financial level and physical activity were the most significant predictor of the elder's QoL. Chronic diseases and activities of daily living as need factors affect the QoL of participant indirectly.CONCLUSION:The results showed that the participant's QoL was at a moderate level. Utilizing of primary health-care services was the weakest predictors of QoL. Sex, marital status, and education level were not reliable predictors of QoL in elders. Other predisposing, enabling, and need factors should be investigated to find the main determinants to improve elder's QoL.

Effect of yoga on pulmonary function test, thyroid-stimulating hormone estimation, hand grip strength, and quality of life in participants with thyroid dysfunction: A pre-post clinical trial

Background: Thyroid dysfunction is the most common occurring endocrine disorder among the general population. According to projections from several readings on thyroid disease, 42 million people in India have been estimated to be suffering from diseases as a result of thyroidism. Yoga has been found valuable in numerous diseases. Yogic exercise restores body roles through the manipulation of cardiovascular, respiratory, and metabolic control mechanism. Yoga has been proven to be an effective adjunct in thyroid conditions in various studies.Objectives: The objective of this study is to assess the effect of yoga on respiratory function, thyroid-stimulating hormone estimation, and hand grip strength as well as quality of life (QoL) in participants with clinically diagnosed thyroid dysfunction.Methods: Twenty-five participants aged between 20 and 50 years were enrolled for the trial. Yoga sessions of four times a week for 3 weeks were given to every subject. Pulmonary function test (PFT), thyroid function, grip strength as well as QoL was measured pre as well as post intervention.Results: Highly significant variations (P < 0.001) were noted within PFT, thyroid function, grip strength as well as QoL parametersConclusion: Significant effect was found within all the parameters of PFT, thyroid function, hand grip strength as well as QoL following 3 weeks of yoga training.

Visual and Hearing Impairments among Working and Retired Employees with Type 2 Diabetes Mellitus in Two Academic Communities in the Phili

Objectives. 1) To describe the sociodemographic and clinical characteristics of working and retired employees aged 55 years and older; 2) To determine the proportion with visual and hearing impairments in participants with Type 2 diabetes mellitus (T2DM); and 3) To determine the association between quality of life in participants with T2DM and visual and hearing impairments. Methods. The study utilized a cross-sectional study design - data derived from the findings of the UP Wellness Initiative for Seniors and Elders (UPWISE) Program. The participants were working and retired university employees age 55 years and above residing in urban and rural-urban (rurban) communities. Stratified random sampling was utilized according to working status and sex. Visual and hearing impairments, and the presence of T2DM were assessed using a multidisciplinary diagnostic process, the comprehensive geriatric assessment (CGA). Results. A total of 301 participants agreed to participate and completed the CGA. The mean age of the participants was 64.8 (±6.3), and 51.2% belonged to the young-old subgroup. There was an almost equal proportion of males and females while there were more working (53.8%) than the retired (46.2%). There were 17.6% of participants with T2DM and of them, 47.2% with visual impairment (VI) alone, 7.5% hearing impairment (HI) alone, and 37.7% with dual sensory impairments (DSI). Good quality of life was reported by 100% of T2DM participants with HI, 80% with VI, and 72.3% with DSI. There was no significant association between quality of life and vision and hearing impairments. On the other hand, a significant association was identified between T2DM and DSI (p-value, 0.001). Conclusion. T2DM and vision and hearing impairments are prevalent among the two academic communities. Visual impairment was more common than hearing impairment. Participants diagnosed with T2DM and having a visual, hearing, or dual sensory impairments reported good quality of life.

Psychological Distress and Quality of Life in Participants Undergoing Genetic Testing for Arrhythmogenic Right Ventricular Cardiomyopathy Caused by TMEM43 p.S358L: Is It Time to Offer Population-Based Genetic Screening?

Purpose: We have identified 27 families in Newfoundland and Labrador (NL) with the founder variant TMEM43 p.S358L responsible for 1 form of arrhythmogenic right ventricular cardiomyopathy. Current screening guidelines rely solely on cascade genetic screening, which may result in unrecognized, high-risk carriers who would benefit from preemptive implantable cardioverter-defibrillator therapy. This pilot study explored the acceptability among subjects to TMEM43 p.S358L population-based genetic screening (PBGS) in this Canadian province. Methods: A prospective cohort study assessed attitudes, psychological distress, and health-related quality of life (QOL) in unselected individuals who underwent genetic screening for the TMEM43 p.S358L variant. Participants (n = 73) were recruited via advertisements and completed 2 surveys at baseline, 6 months, and 1 year which measured health-related QOL (SF-36v2) and psychological distress (Impact of Events Scale). Results: No variant-positive carriers were identified. Of those screened through a telephone questionnaire, >95% felt positive about population-genetic screening for TMEM43 p.S358L, though 68% reported some degree of anxiety after seeing the advertisement. There were no significant changes in health-related QOL or psychological distress scores over the study period. Conclusion: Despite some initial anxiety, we show support for PBGS among research subjects who screened negative for the TMEM43 p.S358L variant in NL. These findings have implications for future PBGS programs in the province.

Relationship between sleep efficacy endpoints and measures of functional status and health-related quality of life in participants with narcolepsy or obstructive sleep apnea treated for excessive daytime sleepiness.

This study examined the correlation between improvements in excessive daytime sleepiness in participants with obstructive sleep apnea or narcolepsy and changes in functional status, work productivity and health‐related quality of life. Data from two 12‐week randomized controlled trials of solriamfetol were analyzed. Participants completed the Epworth Sleepiness Scale, 10‐item Functional Outcomes of Sleep Questionnaire, Work Productivity and Activity Impairment questionnaire and 36‐Item Short Form Health Survey and performed the Maintenance of Wakefulness Test at baseline and weeks 4, 8 and 12. Patient Global Impression of Change was assessed at weeks 4, 8 and 12. Pearson correlations were calculated for change in scores from baseline to week 12. For both studies, changes in the 10‐item Functional Outcomes of Sleep Questionnaire were highly correlated (absolute value >0.5) with changes in Epworth Sleepiness Scale scores; changes in multiple domain scores of the 36‐Item Short Form Health Survey and Work Productivity and Activity Impairment questionnaire were moderately correlated (0.3–0.5) with changes in Epworth Sleepiness Scale scores in both studies and highly correlated for participants with narcolepsy. Changes in Maintenance of Wakefulness Test scores correlated moderately with changes in Epworth Sleepiness Scale scores in both studies. At week 12, Patient Global Impression of Change ratings correlated highly with Epworth Sleepiness Scale and 10‐item Functional Outcomes of Sleep Questionnaire scores for both disorders. Other correlations were low. Self‐reported assessments of sleepiness and global improvement appear to be more strongly correlated with measures of functioning and health‐related quality of life than objectively assessed sleepiness.