Improve Quality Of Life Research Articles

Deep brain stimulation of the subthalamic nucleus for a patient with drug resistant juvenile myoclonic epilepsy: 1year follow-up.

Drug-resistant juvenile myoclonic epilepsy (DR-JME) remains a significant challenge in neurology. Traditional management strategies often fail to achieve satisfactory control, necessitating innovative treatments. This case report aims to evaluate the efficacy and safety of deep brain stimulation (DBS) targeting the subthalamic nucleus (STN-DBS) in a patient with DR-JME. We describe the treatment of a patient with DR-JME using STN-DBS. The patient underwent implantation and received high-frequency stimulation (HFS) at the STN. One year post-implantation, the patient demonstrated a substantial reduction in motor seizure frequency by 87.5%, with improvements in quality of life and seizure severity by 52.0% and 46.7%, respectively. No adverse events were reported during the follow-up period. This case represents the first report of favorable outcomes with STN-DBS in a patient with DR-JME, suggesting that long-term HFS of the STN may be a promising treatment option for patients suffering from this condition.

Design of a Health Education Program to Manage Chronic Neck Pain: Protocol for a Development Study.

Chronic neck pain (CNP) needs attention to its physical, cognitive, and social dimensions. We aimed to design a health education program (HEP) with a biopsychosocial approach for patients with CNP. A literature search on CNP, health education, and biopsychosocial models was carried out. Seven physiotherapists with expertise in HEPs and chronic pain participated in three teams that evaluated the literature and prepared a synthesis document in relation to the three target topics. Experts compiled the information obtained and prepared a proposal for an HEP with a biopsychosocial approach aimed at patients with CNP. This proposal was tested in the physiotherapy units of primary care health centers belonging to the East Assistance Directorate of Madrid, and suggestions were included in the final program. The HEP for CNP with a biopsychosocial approach consists of 5 educational sessions lasting between 90 and 120 minutes, carried out every other day. Cognitive, emotional, and physical dimensions were addressed in all sessions, with particular attention to the psychosocial factors associated with people who have CNP. The proposed HEP with a biopsychosocial approach emphasizes emotional management, especially stress, without neglecting the importance of physical and recreational exercises for the individual's return to social activities. The objective of this program was to achieve a clinically relevant reduction in perceived pain intensity and functional disability as well as an improvement in quality of life in the short and medium term. ClinicalTrials.gov NCT02703506; https://clinicaltrials.gov/study/NCT02703506. DERR1-10.2196/56632.

Efficacy and safety of leadless ventricular pacemaker: a single-center retrospective observational study.

The Micra leadless pacemaker (MLP) has been demonstrated to be safe and effective as a substitute for conventional transvenous ventricular pacemakers (TVP). However, its application in the general population is still restricted. The aim of this retrospective study was to assess the safety and efficacy of MLP. Clinical data and device parameters were gathered on every patient receiving MLP implantation between 1 January 2019 and 31 December 2023, in the First Affiliated Hospital of Soochow University. The efficacy of MLP on the primary composite endpoint, atrioventricular (AV) synchrony, hospitalization, and post-implantation quality of life was assessed. Safety outcomes included implantation procedural characteristics, acute and chronic complications, and stability of pacing parameters. Meanwhile, we compared pacing parameters, AV synchrony, and improvement of life quality between patients who had been implanted with the MicraTM VR (Medtronic Micra™ MC1VR01) and Micra™ AV (Medtronic Micra™ MC1AVR1). Multivariate linear regression models were used to unearth potential predictors of echocardiography or electrocardiogram (ECG) parameters on pacing parameters. A total of 94 patients were included, and implantation was successful in all of the cases. A single patient experienced effusion hours after the implantation, indicating a low rate of both acute and chronic complications. In patients with complete AV block (AVB), Micra AV increased AV synchrony from 23.2%±6.3% to 80.8%±5.7%. After 28 days of implantation, the patients' Minnesota Living with Heart Failure Questionnaire (MLHFQ) score decreased from 27.1±18.6 to 20.0±17.6, and none of them required hospital readmission. Left ventricular end-diastolic diameter (LVEDD, 50.0±6.7 cm), left ventricular end-systolic diameter (LVESD, 32.6±3.9 cm), and ECG R wave in lead V5 (RV5, 1.3±0.6 mV) can be employed for the prediction of pacemaker threshold [0.50 (0.38-0.67) mV], sensing voltage (10.1±4.7 mV), and impedance (785.9±226.4 Ohm) correspondingly. Despite being a small, single-center, retrospective study, our study provided data for assessing the safety and efficacy of MLP. Clinicians and patients can make well-informed therapy decisions by being aware of its benefits and forecasting pacing parameters.

"Fully endoscopic preperitoneal ascending suprapubic approach for minimally invasive repair of anterior and lateral abdominal wall hernias".

The aim of this work is to describe the rational, feasibility and clinical and Quality-of-life improvement results of a fully endoscopic preperitoneal repair for midline and lateral abdominal wall hernias, starting from the space of Retzius in a "bottom-to-up" approach. An observational prospective data-collected and quality of life study is performed in selected patients with less than 10cm. in diameter midline and lateral abdominal wall hernias. A suprapubic upward e-TEP technique from a previously dissected Retzius space, is performed in all cases. The surgical goal is to perform a total free-tension abdominal wall reconstruction followed by a prosthetic hernioplasty. Clinical Data is classified in preoperative, intraoperative, and postoperative variables, including a quality-of-life clinical evaluation based on an improvement of HerQLes score. A total of 30 patients underwent this approach from September 2017 to October 2022 in a single-surgeon practice. A total restoration of the previous abdominal wall anatomy and a prosthetic repair were achieved in all cases. The mean operative time was 142.53min, with a significant shorter time in lateral hernias approach. Minor complications (Clavien-Dindo I) were collected in 10% of the patients. Major complications (Clavien-Dindo IIIb) occurred in 6.66% of the patients. The mean pain at discharge was 1.83 VAS, with a significant lower pain in M-eTEP approach for lateral hernias. The mean hospital stay was 42.4h. No seroma, hematoma, chronic pain, or recurrence was observed in the mean follow-up (20.33months). A clinical and quality of life improvement was found in 92.9% of the patients, measured by a minimal clinical important difference (MCID) between preoperative and postoperative HerQLes score. Despite being a technically demanding approach, the results obtained by this approach are compatible in safety and feasibility with other minimally invasive preperitoneal hernia repair techniques, in addition to obtaining a significant improvement in the quality of life of patients.

Patient-Reported Quality of Life for Osteoradionecrosis Reconstruction in the Head and Neck: A Longitudinal Framework and Risk Factors.

Osteoradionecrosis (ORN) is an aggressive sequela of head and neck cancer, treatment of which focuses on functional restoration and quality-of-life (QoL). This study aims to identify risks for poor QoL in ORN reconstruction and build a chronologic, longitudinal framework for QoL. A prospective database of reconstructions performed by the senior author was reviewed from 2015-2023. QoL metrics (University of Washington [UWQoL]v4) were prospectively administered prior to surgery, one year post-operatively, and each yearly follow-up. 56 ORN patients were included (average 58.2years, mean 6,412Gy radiation). Reconstruction commonly was achieved with the fibula(55.4%) and anterolateral-thigh flaps(37.5%). The total complication rate was 23.2%, median 10.7mo post-operatively.Both "health-related QoL in comparison with prior to cancer diagnosis" (62.5 vs 43.5;p=0.030) and "Overall QoL during the past 7-days" (50.5 vs 41.7;p=0.029) were higher post-ORN reconstruction than before. Physical-QoL was higher pre-cancer reconstruction (79.0) than prior to ORN reconstruction (50.6;p<0.001) and following reconstruction (52.5;p=0.001). Social-emotional function was higher following ORN reconstruction compared to pre-reconstruction (68.7 vs 59.6;p=0.010).On multi-variate analysis, both post-operative social-emotional and physical function were impacted by betelnut use (p=0.038;p=0.025). Poor improvement in QoL from pre to post-ORN reconstruction were affected by maxilla involvement (p=0.048), fistula (p=0.004), and hardware issues (p=0.001). Our longitudinal experience trended decline in QoL at ORN diagnosis with gradual improvement following reconstruction, with eventual social-emotional, pain, anxiety, chewing, and global-QoL significantly improved following surgery. Betelnut was a risk factor for poor post-operative QoL. Maxillary involvement, post-op fistula and hardware issues were risks for non-improvement in QoL.

Effects of biopsychosocial approach on cognition among Parkinson's population.

Cognitive decline is a debilitating symptom in Parkinson's disease (PD). Cognitive impairment in PD has a significant impact on many aspects of an individual's life, social interactions, and overall quality of life (QOL). It is also associated with a faster disease progression and an increased risk of developing dementia. A biopsychosocial approach is likely to address not only the underlying biological mechanisms of cognitive impairment in PD but also the psychological and social factors that can contribute to cognitive decline and influence treatment outcomes. This experimental study was conducted on 60 older adults with PD at Saveetha medical college and hospital. Participants who met the inclusion criteria were randomly allocated into two groups of Biopsychosocial (n=30) and conventional (n=30). Participants in the intervention group received the multiple interventions based on the biopsychosocial approach with a duration of 60min per session. Pre and post-test evaluation conducted using Scales for Outcomes in PD-cognition (SCOPA-cog) and Parkinson disease QOL Questionnaire (PDQ-8). The results of the study showed that there is a statistically significant difference in the median scores within the Groups for the outcome measures SCOPA-cog and PDQ-8 (p<0.001). For SCOPA-cog, the BPS group median score increased from 30 to 36, while the Conventional group median score increased from 31 to 33. For PDQ-8, the BPS group median reduced from 27 to 14, compared to the Conventional group's reduced from 30 to 24. On comparison between the post-test values, the biopsychosocial approach group showed more improvement in cognition and QOL with (p<0.001). The findings of this study concluded that the biopsychosocial approach is effective in improving cognition and QOL among the Parkinson population.

Exploring How the Kidney BEAM Physical Activity Digital Health Intervention Improved Mental Health-Related Quality of Life for People Living With Kidney Disease: a Mixed Methods Approach

IntroductionThe Kidney BEAM randomised controlled trial reported clinically meaningful and statistically significant improvements in mental health-related quality of life (HRQoL), physical function (sit-to-stand-60, but not the physical component of HRQoL) and patient activation following a 12-week physical activity digital health intervention (DHI). This study explores factors that contributed to the effectiveness of Kidney BEAM through mixed methods analyses. MethodsQuantitative data analysis was taken from the recently published primary manuscript. Participants from the Kidney BEAM trial intervention group (n=30) completed individualized semi-structured interviews after the 12-week DHI. Interviews were analysed using the framework method with inductive and deductive coding. Quantitative and qualitative data collection and analyses occurred concurrently, and independently, before combining using a mixed methods analysis with joint displays to triangulate datasets and further explore the primary findings. ResultsThe integrated mixed methods analyses facilitated explanation of the primary findings. The Kidney BEAM intervention was shown to have mental and physical wellbeing benefits and enhanced self-management in this cohort of people living with CKD. Elements that contributed to the effectiveness of the intervention were reported, including the different functional levels and gradual progression of the program, shared lived experiences with other participants, self-monitoring, the sense of achievement, taking back control of their health, moving beyond medications and feeling safe and confident to exercise. ConclusionElements of the Kidney BEAM intervention that contributed to the main quantitative trial findings were identified. This will allow researchers and practitioners to maximize the effectiveness of DHI’s to enhance healthy behaviours in people living with CKD.

Continuous Subcutaneous Foslevodopa-Foscarbidopa in Parkinson's Disease: A Mini-Review of Current Scope and Future Outlook.

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms, primarily because of the impairment of dopaminergic neurons. Long-term use of levodopa, the standard PD treatment, often results in fluctuating therapeutic effects and dyskinesia, necessitating alternative therapies. This review aims to synthesize current insights and clinical experiences with foslevodopa-foscarbidopa, focusing on its pharmacokinetics, efficacy, and safety profile, to evaluate its potential in transforming PD therapy. A systematic literature search was conducted up to November 2023 using databases PubMed, Web of Science, and Cochrane Library. The search yielded eight eligible articles, including pharmacological studies, case reports, observational studies, and controlled trials. No language restrictions were applied. Foslevodopa and foscarbidopa, as prodrugs of levodopa and carbidopa, exhibited excellent chemical stability and solubility, facilitating continuous subcutaneous infusion. Clinical trials demonstrated that these prodrugs maintain stable levodopa levels, thereby addressing the limitations of oral levodopa therapy. Phase 1 and 3 studies indicated significant improvements in motor function and quality of life in advanced PD patients. However, a higher incidence of treatment-emergent adverse events, mainly infusion site reactions, was observed compared to oral therapies. Foslevodopa-foscarbidopa emerges as a promising alternative for advanced PD treatment, offering sustained symptom control. Its efficacy in managing motor fluctuations and dyskinesia makes it a viable option in the PD therapeutic spectrum. Future research should focus on long-term safety, economic impact, and broader accessibility. Foslevodopa-foscarbidopa is now commercially distributed in many countries in Europe and in Japan.

High-flow nasal cannula in adults with chronic respiratory diseases during physical exercise: a systematic review and meta-analysis

BackgroundChronic respiratory diseases (CRDs) affect at least 545 million people globally, leading to symptoms such as dyspnoea, fatigue and limited physical activity. Pulmonary rehabilitation (PR) programmes aim to improve the...

S227 Improvement in Health-Related Quality of Life in Adults with Recurrent Clostridioides difficile Infection After Fecal Microbiota, Live-jslm (RBX2660) Administration by Colonoscopy

S227 Improvement in Health-Related Quality of Life in Adults with Recurrent Clostridioides difficile Infection After Fecal Microbiota, Live-jslm (RBX2660) Administration by Colonoscopy

Improvement in thyroid-specific quality of life following radiofrequency ablation of benign thyroid nodules: A USA study

BackgroundRadiofrequency ablation is an effective minimally invasive technique for benign thyroid nodules, with European and Asian studies reporting improved quality of life following treatment. We aimed to assess the thyroid-related quality of life of patients with benign thyroid nodules treated with radiofrequency ablation in the United States. MethodsThis is a prospective single-institution study of patients treated with radiofrequency ablation over a 4-year period. Nodule characteristics and Thyroid-Related Patient-Reported Outcome (ThyPRO)-39 scores were assessed at baseline, 3 months post-procedure, and last follow-up (range: 3–12 months). Wilcoxon signed-rank test was used to assess differences in scores before and after radiofrequency ablation with standardized effect size analysis. ResultsA total of 56 patients with 76 nodules were treated. The median volume reduction ratio at 1, 3, 6, and 12 months was 44.9% (interquartile range: 27.3–57.3), 65.2% (53.5–73.1), 69.7% (63.5–81.9), and 79.6% (66.2–88.9), respectively. At 3-month follow-up, significant improvement (P < .05) was observed for goiter symptoms (28.9 vs 10.8), anxiety (30.7 vs 19.3), and appearance (29.9 vs 10.8). At last follow-up, significant improvement (P < .05) was observed for goiter symptoms (28.9 vs 8.9), anxiety (30.7 vs 22.3), appearance (29.9 vs 10.8), and overall quality of life (30.3 vs 11.1). Effect sizes were moderate for appearance (standardized effect size 0.5–0.8) at last follow-up. ConclusionIn the largest US study to date assessing quality of life following radiofrequency ablation, we observed an expected volume reduction ratio and improvements in thyroid-specific quality of life, particularly in the goiter, anxiety, and appearance domains.

Food for Cancer Health Equity: The impact of a culturally tailored food voucher intervention on food insecurity among Latinx patients with cancer.

182 Background: Food insecurity disproportionately impacts immigrant, low-income, and racial and ethnic minorities with cancer. In our prior qualitative work, Latinx and multiethnic patients with food insecurity emphasized the importance of culturally-tailored food assistance interventions that could minimize stigma and maintain self-efficacy and autonomy. In collaboration with Latinx patients and community partners in Monterey County, California, we co-developed a culturally-tailored food voucher intervention. In this study, we conducted a pilot of the intervention among multiethnic and Latinx patients with cancer and tested the impact on food insecurity and health-related quality of life. Methods: We recruited low-income, racial and ethnic minority adults &gt; 18 years of age who screened positive for food insecurity using the 2-item Hunger Vital Sign while receiving cancer treatment in a clinic in Monterey County, CA between July 2023 until August 2023. All participants who consented to participate received $40 monthly grocery store gift cards redeemable at a variety of local retailers for 6 months in addition to usual care provided by trained community health workers who assisted with other health-related social needs. We conducted validated surveys at baseline (time of enrollment) and 6-month follow-up (post-intervention) assessing demographics, food behaviors, food insecurity, and health-related quality of life, as well as feasibility and acceptability of the intervention. We compared pre- and post-intervention proportions with food insecurity using McNemars tests and change in health-related quality of life using paired t-tests. Results: Of the 30 study participants enrolled, 27 (90%) were Latinx; 24 (80%) spoke Spanish as their preferred language; 16 (53%) had advanced (stage 3 or 4) cancer; 12 (40%) were retired or unemployed; 10 (33%) were disabled; 20 (67%) reported a household income &lt; $35,000 USD. Of the 26 (87%) participants who completed post-intervention surveys, the proportion with food insecurity decreased from 100% to 65% (95% CI 0.60-0.77; p = 0.01); 100% adhered to recommended treatment; and health-related quality of life scores increased by 8 points from 71.9 +/-16.1 to 79.5+/- 10.5 (p = 0.02) from baseline. All (100%) participants rated the program as feasible and acceptable in post-intervention surveys. Conclusions: This culturally-tailored food voucher intervention was associated with reductions in food insecurity and improvements in health-related quality of life among low-income Latinx patients with cancer. This intervention may represent an effective and acceptable approach to overcome food insecurity in Latinx and multiethnic patients with cancer.

Age-specific clinical results in spinal meningioma surgery: should age still be considered detrimental to satisfactory outcomes?

Spinal meningiomas (SMs) are relatively rare primary spinal neoplasms, and the increasingly growing mean age and number of older patients presenting with spinal neoplasms raise questions concerning the costs and benefits of proposing surgical intervention. The aim of this study was to analyze the outcomes and complications of a large cohort of older patients with SMs to define the real benefit of surgery in these patients. A total of 261 SMs were operated on between 1976 and December 2021, and 156 matched the inclusion criteria for the final cohort. Patients were divided into three groups according to age: < 50 years (group A), between 51 and 74 years (group B), and > 75 years (group C). Neurological and clinical outcomes, resection grade, complications, histology, and possible recurrences were evaluated. The final cohort comprised 156 patients (126 females, 30 males) with a mean ± SD age of 55.93 ± 14.80 years. The mean follow-up was 41.5 ± 11.4 months. Group A was found to have a significantly higher Frankel score at follow-up; there was no significant difference between mean scores for groups B and C. Nevertheless, there was no significant difference between the subgroups in patients who showed improvement from their preoperative neurological condition. Only 3 recurrences were recorded, all in group A. Axial topography, level of the lesions, and preoperative symptoms, including impairment of the sphincter functions, demonstrated no statistically significant interaction in the subgroups. The present study supports the concept that older age might not be a contraindication for surgical treatment in SMs because of the important improvements in functional status and quality of life achieved in this population subgroup. Older patients can benefit from prompt assessment and early surgery in cases of acute onset, with a complication rate not higher than that of younger patients.

Survey on first-line therapeutic management of relapsing–remitting multiple sclerosis in clinical practice in Spain

IntroductionCurrent therapies for relapsing–remitting multiple sclerosis (RRMS) help reduce morbidity and delay disease progression. However, the available information on factors influencing decision-making regarding first-line treatment remain poorly understood. MethodsBased on a review of the literature and the experience of a scientific committee made up by 2 neurologists, an ad hoc survey was developed and distributed to Spanish neurologists. It included 22 questions related to the first-line therapeutic management of RRMS. ResultsSixty neurologists (mean age: 45.6 years, 60% women, mean of 16.0 years of experience, mean of 93.8 patients with RRMS attended/month) participated in the study. Neurologists considered that the 3 most important treatment characteristics (1–8 points, with higher scores denoting greater relevance) in treatment decision-making were efficacy in disease control (7.8±0.5), safety/tolerability (6.7±0.9), and improvements in patient quality of life (5.0±1.5); regarding patient characteristics, the 3 most important (1–7 points) were disease activity (6.9±0.5), intention to become pregnant (5.0±1.0), and level of disability (4.3±1.8). Dimethyl fumarate (32.6%) was the most frequently prescribed treatment, followed by teriflunomide (24.8%) and glatiramer acetate (17.6%). According to over 87% of the specialists, the latter drug was considered the most appropriate treatment for patients with liver disorders, who intended to become pregnant, and who presented low disease activity. ConclusionsOur study provides evidence on the first-line therapeutic management of non-aggressive forms of RRMS and the factors influencing decision-making in routine clinical practice.

Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial.

Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR). We performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients. The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models. The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95%CI: 7.4-16.3 points) at 30days, 20.8 points (95%CI: 16.1-25.5 points) at 6months, and 17.8 points (95%CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction P=0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS≥60 points and no decline of≥10 points from baseline) compared with 31.0% with OMT alone. Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life. These benefits were evident 30days after TTVR, continued to increase through 6months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; NCT04482062).

ID: 319439 Improvements in Health-Related Quality of Life in Chronic Back/Leg Pain Patients with Closed-loop SCS

ID: 319439 Improvements in Health-Related Quality of Life in Chronic Back/Leg Pain Patients with Closed-loop SCS

Developing a Motion Sensor-Based Game to Support Frozen Shoulder Rehabilitation in Older Adults through a Participatory Design Approach.

Objective: Although some serious games have been developed for physical therapy, little work has been conducted through a participatory design approach. Therefore, a game prototype was developed, which involved related stakeholders in the design process. Materials and Methods: The iterative participatory design process was adopted with the input of 18 patients with frozen shoulder symptoms, 4 health professionals, 2 game designers, and 5 researchers in an iterative process to design, test, and evaluate the game prototype. In total, 17 patients participated in the interviews to explore their needs and desires for a serious game. The health professionals participated in the interviews to understand the medical requirement and experience pertaining to frozen shoulder and were included in the workshop to give feedback on the game prototype. At the conclusion of the iterative design process, a Kinect-based prototype game with three levels was used for a case study with one patient who was diagnosed with frozen shoulder and has been receiving medical treatment in the hospital. Results: Based on the outcomes derived from data collected among diverse stakeholders, the prototype game underwent iterative development by the team and was assessed by a participant with frozen shoulder symptoms. Findings revealed that the participant demonstrated enhanced shoulder mobility and a reduction in pain intensity, despite the lack of significant improvement for health-related quality of life. Nevertheless, the participant reported a positive experience with the prototype game. Conclusion: This study underscores the importance of involving diverse stakeholders in the development process to create more effective and user-centric serious games for rehabilitation. The participatory approach, exemplified by the prototype game, demonstrates potential improvements in both user experience and overall effectiveness during the rehabilitation process.

Spinal Neuromodulation for Peripheral Arterial Disease of Lower Extremities: A Ten-Year Retrospective Analysis.

This long-term retrospective study evaluated the survival and amputation outcome of subjects who received neuromodulation therapy for the management of peripheral arterial disease (PAD). The study reviews the health data of a single cohort of 51 patients who received spinal neuromodulation (spinal cord stimulation [SCS] or dorsal root ganglion stimulation [DRG-S]) for PAD from 2007 to 2022 in a single German center. Survival rate and major amputation rate were determined. Pain, quality of life, walking distance, and opioid usage were assessed before implantation (baseline), one, six, and 12 months (M) after implantation, and then annually (during a follow-up visit). Implant-related complications also were documented. In total, 51 patients (37 men [mean age 68.9± 10.2 years], 14 women [mean age (68.7± 14.6 years]) underwent SCS (n= 49) or DRG-S (n= 2) implantation owing to persistent ischemic pain. The follow-up mean years± SD is 4.04± 2.73. At baseline, patients were classified as Rutherford's category 3 (n= 23), category 4 (n= 15) or category 5 (n= 9). At 24 M, 42 of 47 patients did not require a major amputation after the implant. All the patients reported nearly complete pain relief from pain at rest. A total of 75% of patients were able to walk >200 m, and 87% of patients who used opioids at baseline were off this medication at 24 M. Overall, 93% of patients reported an improvement in their overall health assessment. These improved outcomes were sustained through years three to 10 for patients who have reported outcomes. Our single-center data support the efficacy of spinal neuromodulation for improvements in limb salvage, pain relief, mobility, and quality of life. The data also show that neuromodulative therapy has a long-term therapeutic effect in patients with chronic limb pain with Rutherford category 3, 4, and 5 PAD.

Temazepam or Melatonin Versus Placebo for the Treatment of Insomnia in Advanced Cancer: A Three-Arm, Double-Blind, Phase III, Multicenter, Randomized Clinical Trial.

Background: Sleep disturbance has a prevalence of 30-78% in patients with advanced cancer. While pharmacotherapy is common, randomized controlled studies (RCTs) investigating available agents are limited. This study examines the efficacy and safety of temazepam or melatonin versus placebo for sleep in advanced cancer. Methods: This is a multicenter, randomized, double-blind, placebo-controlled study of temazepam, melatonin prolonged release (PR) or placebo for insomnia in patients with advanced cancer, and an insomnia severity index (ISI) score of >11. Results: Twenty-one participants were randomized: nine to temazepam, eight to melatonin, and four to placebo. Baseline characteristics between groups were similar. The adjusted mean difference in day 8 ISI score versus placebo was -9.1 (95% confidence interval [CI] -17.5, 0.7, p = 0.04) for temazepam and -9.6 (95% CI -18,-1.2, p = 0.03) for melatonin PR. There was no improvement in global quality of life. Both agents were well tolerated. Conclusion: Temazepam and melatonin PR were associated with a clinically significant improvement in patient-reported insomnia severity compared with placebo. Findings need confirmation with larger patient numbers.

A one-year weight management programme for difficult-to-treat asthma with obesity: a randomised controlled study

BackgroundObesity-associated asthma results in increased morbidity and mortality. We report one-year asthma outcomes with the Counterweight-Plus weight management programme (CWP) compared to usual care (UC) in a single-centre, randomised, controlled trial in patients with difficult-to-treat asthma and obesity. Research QuestionCan CWP use result in improved asthma control and quality of life compared to UC at one-year in patients with difficult-to-treat asthma and obesity? Study design and methodsWe randomised (1:1 CWP:UC) adults with difficult-to-treat asthma and body mass index ≥30kg/m2. CWP with dietitian support: 12-week total diet replacement phase (850kcal/day low-energy formula); food reintroduction and maintenance phases up to one-year. Outcomes include Asthma Control Questionnaire (ACQ-6), Asthma Quality of Life Questionnaire (AQLQ) and healthcare usage. Minimal clinically important difference (MCID) is 0.5 for ACQ-6 and AQLQ. ResultsOf 36 recruited, 29 attended at 52-weeks: 13 CWP, 16 UC. CWP resulted in greater weight change (median –14kg [IQR –15, –9]) compared to UC (2kg [-7, 8]; p=0.015) at 52-weeks. A greater proportion achieved MCID with CWP vs UC in AQLQ (71% vs 6% respectively; p<0.001). No between-group differences were observed in ACQ-6. Median exacerbation frequency reduced over 52-weeks with CWP from 4 (IQR 2, 5) to 0 (0, 2) (p<0.001), though no between-group difference was observed. 70% of the CWP group lost ≥10% body weight and had improvement in ACQ-6 (mean difference –1.1, 95%CI –1.9, -0.3; p=0.018) and AQLQ (1.2, 95%CI 0.4, 2.1; p=0.011) across 52-weeks. InterpretationUse of a dietitian-supported weight management programme results in sustained weight-loss and is a potential treatment for obesity in asthma. CWP resulted in a higher proportion achieving MCID improvement in AQLQ compared to UC. Within group differences in AQLQ and exacerbation frequency suggest potential with CWP. These encouraging signals justify a larger sample study to further assess asthma-related outcomes.