Improvement In QOL Research Articles

Clinical pharmacist interventions on pain management in cancer patients (PharmaCAP) in low resource settings: a multicenter feasibility-pilot randomized controlled trial.

Cancer pain management is frequently insufficient worldwide, especially in low- and middle-income countries where significant challenges related to workforce resources persist. Clinical pharmacists could potentially enhance outcomes in this context, yet their role remains largely unexplored. This study aimed to assess the feasibility and acceptability of integrating clinical pharmacists into the multidisciplinary team (MDT) to manage cancer pain and assess preliminary outcomes in cancerpatients receiving pain treatment. This pilot study was undertaken to inform a future definitive randomized controlled trial (RCT). The protocol was registered with ClinicalTrials.gov (NCT05021393). The PharmaCAP trial was conducted in two oncology centers in Nepal, where patients were randomly enrolled into usual care (UC) or an intervention group (PharmaCAP). The latter received a clinical pharmacist-led medication review, which involved a comprehensive assessment of the patient's current medications, identification of potential drug-related problems, and personalized recommendations for optimizing pain management. This was accompanied by pain assessment, educationand counseling on pain management strategies. Baseline and 4-weeks post-intervention assessments measured primary outcomes, i.e., feasibility metrics (recruitment of the patients, retention of patients, patient satisfaction). Secondary outcomes included pain intensity, health-related QoL, anxiety, depression, barriers to pain management, and medication adherence at 4weeks. Out of 140 screened patients, 108 were evaluated for eligibility, with 16 opting out primarily due to lack of interest (n = 11) and communication barriers (n = 5). A total of ninety-two participants with cancer pain were randomized into two groups, with 91 patients successfully recruited and 85 (93.4%) completing 4weeks post-intervention assessment). Completion rates for the UC and PharmaCAP groups were 91.3% and 93.4%, respectively. The primary feasibility outcomes were positive: 100% of patients found random allocation acceptable. Retention rates were high, with 91.3% in the UC group and 93.4% in the PharmaCAP group, despite a few dropouts due to being unreachable, COVID-related issues, and changes in treatment centers. No evidence of contamination between groups was found, as participants did not discuss interventions or influence each other's attitudes, ensuring effective isolation of interventions The PharmaCAP intervention showed significant improvement in QoL (P < 0.001), physical functioning (P < 0.001), and financial difficulties (P < 0.001). There was also clinical benefit observed in anxiety and depression (P < 0.001) and enhancements in medication adherence (P < 0.001). While pain intensity decreased in both groups, the difference was not statistically significant. Satisfaction with the PharmaCAP intervention was high, with 93.0% of participants expressing satisfaction and 88.3% acknowledging that the clinical pharmacists effectively addressed their drug-related queries. Findings of this RCT demonstrate that integrating clinical pharmacists into the MDT team in low low-resource setting is feasible and shows promise in improving QoL, reducing anxiety and depression, and enhancing medication adherence among cancer patients. These findings support the feasibility of conducting a full-scale RCT. Enabling clinical pharmacists to assist with cancer pain management in low-resource settings can benefit patients, healthcare teams, and health systems. ClinicalTrials.gov NCT05021393. Registered on 25th August 2022.

Health-related quality of life in patients after endoscopic or microscopic cholesteatoma surgery.

Different surgical techniques exist for treating cholesteatoma, such as microscopical or transcanal endoscopic ear surgery (TEES). This study aimed to compare these two techniques, focusing on quality of life. This retrospective single-center study included 188 patients with cholesteatoma. The primary outcome was the assessment of health-related quality of life (HRQoL) using the Zurich Chronic Middle Ear Inventory (ZCMEI-21) preoperatively, 3 and 12 months postoperatively with regard to surgical technique and intraoperative staging of the cholesteatoma (ChOLE classification). Secondary outcomes included hearing pure tone average of 0.5, 1, 2 and 4kHz (PTA4), complications assessed 3 months postoperatively as well as recidivism within the follow-up time of 1 year postoperatively. A total of 28 patients underwent TEES and 160 microscopic ear surgery. The ZCMEI-21 total scores preoperatively were not significantly different between the two groups. An improvement in QoL one year postoperatively was observed in both groups to a comparable extent. The ZCMEI-21 decreased significantly (p <0.01) in both groups. In the TEES group, the cholesteatoma tended to be smaller (lower ChOLE score), PTA4 was better and complication rate comparable. The number of recidivisms was lower for the TEES group (1 [3.6%] vs. 31 [19.4%]). TEES is a valuable alternative to the traditional microscopic technique, at least for small cholesteatoma, which leads to a comparable improvement in HRQoL as the microscopic technique. The better postoperative hearing and lower rate of recidivism in the TEES group may be related to the smaller extent of the cholesteatoma.

DISP-08. GBM PATIENTS FACE TTF ACCESS AND INFORMATION INEQUITY THAT MAY IMPACT PATIENT OUTCOMES AND QUALITY-OF-LIFE

Abstract We evaluated the quality and accessibility of healthcare for Glioblastoma (GBM) patients across the United States through an online survey distributed to the OurBrainBank community and partners and promoted on social media. A total of 297 patients or caregivers completed the survey (85% caregivers; 15% GBM patients). Median age at diagnosis was 57, lower than the national average. 78% described having some college education, and 69% reported commercial insurance coverage. Our preliminary findings highlight that 82% of respondents reported that their treating doctor recommended the standard-of-care for GBM consisting of tumor resection, 3-6 weeks of chemo/radiation, and 6 months of chemotherapy and sometimes Tumor-Treating-Fields (TTF), per the Comprehensive- Cancer-Network (2021) guidelines. 40% reported no discussion of TTF as an option. Of those offered TTF, nearly half (46%) received it as part of their initial treatment combined with standard chemotherapy and 36% received it as a subsequent option. For those attempting to access TTF, 29% encountered difficulties, often due to financial constraints linked to insurance denials. These findings illuminate significant concerns regarding dissemination of information on treatment options, as well as access to treatments. Access to these treatments can have a significant influence on survival and quality of life of GBM patients. The substantial number of patients not offered TTF, combined with challenges to accessing treatments due to insurance issues, highlight critical obstacles to engaging in informed and shared decision-making. Compared to the general GBM-affected population, our survey respondents tend to be younger and from urban areas, indicating a possible selection bias in survey participation. This skew could lead to an underrepresentation of the challenges encountered by patients facing additional barriers. We are adopting measures to engage a more diverse participant group, especially from rural communities Ongoing targeted recruitment will further elucidate barriers to patient-centered care in GBM, with the potential for significant improvements in survival and QOL.

Retrospective Review of Spinal Cord Compression Occurrences and Management in Children With Relapsed, Progressing, or Refractory Malignancies.

Spinal cord compression (SCC) is a severe complication in pediatric patients with relapsed, progressing, or refractory solid malignancies. This study aims to report the presentation, treatment, and role of proactive radiation therapy in these patients. This retrospective study reviewed 28 patients with relapsed, progressing, or refractory solid tumors who were referred for radiation therapy consultation due to potential (impending) or actual spinal cord compression (pSCC and aSCC, respectively) over a 12-year period. Collected data included disease characteristics, details of SCC events, management approaches, and patient outcomes. Among the 28 patients, 34 SCC events were identified (18 pSCC, 16 aSCC), with neuroblastoma being the most frequent diagnosis (46.4%). No significant differences were noted between pSCC and aSCC groups in pre-event imaging follow-up, age distribution, or malignancy status at SCC presentation. However, aSCC patients exhibited significantly more symptoms at diagnosis. Both groups received SCC-targeted therapy, with no significant differences in functional outcomes, event-free survival (EFS), or overall survival (OS). Pain assessments post treatment showed comparable improvements in both groups. Proactive radiotherapy for pSCC did not yield superior outcomes compared to reactive treatment for aSCC. Given the limited benefits observed, proactive RT should be considered on an individual basis, balancing potential QoL improvements against treatment burdens. Further research in larger cohorts is necessary to refine therapeutic strategies for SCC in pediatric oncology.

Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease

Below the knee (BTK) lesions may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. Landmark interventional clinical studies have not reached consensus on the optimal standard of care for BTK lesions, and many published trials excluded patients with moderate or severe lesion calcification. Calcium modification with intravascular lithotripsy (IVL) was shown to be superior to percutaneous transluminal angioplasty (PTA) in the femoropopliteal artery and successful in treating BTK lesions in pilot studies. The Disrupt BTK II study is a core-lab adjudicated, prospective, multi-center single-arm study of patients with moderate to severely calcified BTK lesions treated with the Shockwave Medical Peripheral IVL System. Disrupt BTK II enrolled 250 subjects with calcified infrapopliteal lesions and Rutherford category 3-5 presentation from 38 sites in the United States and Europe. The primary safety endpoint was major adverse limb events (MALE) or post-operative death (POD) at 30 days, a composite of all-cause death, above-ankle amputation of the index limb, and/or major reintervention of the index limb involving an infrapopliteal artery. The primary effectiveness endpoint was procedural success, defined as ≤50% residual stenosis for all treated target lesions without serious core lab-adjudicated serious angiographic complications. The study used independent angiographic and duplex ultrasound core laboratories, and follow-up is planned through two years. A total of 305 lesions in 250 patients were treated with a procedural success of 97.9%. Mean target lesion length was 76 ± 65mm, diameter stenosis was 78 ± 18%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core lab. After IVL, residual stenosis was reduced to 29%, and to 26% after optional post-dilatation and/or stent implantation. At 30 days, there were no deaths, MALE rate was 0.8%, and mean improvement in VascuQoL scores was 4.0 ± 5.0 (P<0.0001). Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days. The Disrupt PAD BTK II study demonstrated that treatment with the Shockwave Medical Peripheral IVL System in patients with moderate-severe calcified lesions resulted in high procedural success, significant reduction in residual stenosis, improvements in patient QoL and wound healing, with minimal adverse events at 30-day follow-up.

Early-stage vs established knee osteoarthritis: A comparative observational study on prevalence and changes in pain, function and quality of life after supervised exercise and education among 10,365 patients

ObjectiveCompare prevalence and changes in outcomes among established and early-stage knee osteoarthritis (KOA) patients undertaking supervised exercise and education. MethodsPatients from Good Life with osteoArthritis in Denmark (GLA:D®) were stratified into three groups: established KOA (ACR/EULAR criteria), early-stage KOA (diagnostic-model-outcome ≥70%, Criteria for the Early Diagnosis of knee Osteoarthritis) or potential early-stage KOA (diagnostic-model-outcome 30-69%). Mixed-effects models and the proportion of patients by group achieving minimal clinically important improvements (MCIIs) were used to investigate changes in VAS pain intensity (0-100mm), Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL; 0-100), 40m Walk test and 30s chair-stand test at 3 and 12 months. ResultsCompared to established KOA (61% of 10,365 patients), early-stage KOA (27%) had similar knee pain at baseline (mean (SD); 51 (22) vs 45 (22)), and improvement in pain (mean (95% CI) -15 (-15 to -14) vs -14 (-15 to -13), ≥MCII: 55% vs 54%) and KOOS QoL (≥MCII: 50% vs 50%) at 12 months, and in walking speed (≥MCII: 56% vs 52%) and chair-stands (≥MCII: 55% vs 52%) at 3 months. Compared to either group, potential early-stage KOA (10%) had lower baseline pain (34 (32.7)) and less improvement in pain (-9.8 (-11.3 to -8.2; ≥MCII: 47%)), but comparable improvements in KOOS QoL (≥MCII: 50%), walking speed (≥MCII: 51%) and chair-stands (≥MCII: 51%). ConclusionPatients with early-stage KOA achieved comparable improvements at 3 and 12 months to those with established KOA, supporting supervised exercise and education as a viable management strategy for early-stage KOA.

Comparing outcomes of Aquablation versus holmium laser enucleation of prostate in the treatment of benign prostatic hyperplasia: A network meta‐analysis

AbstractIntroductionWater Jet Ablation Therapy (WJAT) and Holmium Laser Enucleation of the Prostate (HoLEP) represent two common surgical treatments for Benign Prostatic Hyperplasia (BPH). Despite their increasing use, there is no study between these two methods. We aim to evaluate their efficacy and safety through a network meta‐analysis (NMA), providing critical insights for clinical decision‐making in the management of moderate to severe lower urinary tract symptoms (LUTS) due to BPH.MethodsPubmed, EMBASE and Cochrane Library were searched. Randomized controlled trials and prospective single‐arm studies comparing WJAT and HoLEP with TURP, reporting symptom scores, flow rates and adverse events. Data extraction and quality assessments were independently performed. Bayesian modelling in RStudio was used for statistical analysis, evaluating continuous outcomes through mean difference and categorical variables via risk ratios. Risk‐of‐Bias (RoB) and GRADE assessments were performed.FindingsTwenty‐three studies were included (WJAT‐11, HoLEP‐12). Most studies were at some or high risk of bias. At 12 months, the IPSS, Qol, PVR and Qmax improvements were 4.14 points (95% CI: ‐0.34 to 8.64, not‐significant [NS], GRADE‐rating: Low), 0.32‐points (95% CI:‐10.70 to 3.27, NS, GRADE‐rating: Low), 2.45 ml/s (95% CI: ‐1.85 to 7.05, NS, GRADE‐rating: Low), 63.10 ml (95% CI: 39.80 to 87.30, statistically‐significant [SS], GRADE‐rating: Moderate), respectively, all in favour of HoLEP. Haemoglobin‐loss was lower with HoLEP, 1.16 g/dl (95% CI: ‐2.56 to 0.54 mg/dl, NS, GRADE‐rating: Moderate) than WJAT. The risk of incontinence was higher with HoLEP; 4.48 (95% CI: 0.22 to 168.50, NS, GRADE‐rating: Very Low) than WJAT in single–arm analysis. The risk of blood transfusion was higher with WJAT (RR = 0.14; 95% CI: 0.00 to 4.21, NS, GRADE‐rating: Low) than HoLEP. Risk of Total Serious Adverse Events (Clavien‐Dindo grade&gt;3) was higher with HoLEP (RR = 1.12, higher with HoLEP, 95% CI: 0.20 to 12.71, NS, GRADE‐rating: Low) than WJAT. Retreatment was lower with HoLEP (RR = 0.46, 95% CI: 0.02 to 10.54 GRADE‐rating: Low) than WJAT.InterpretationOur study suggests that both HoLEP and WJAT are effective treatments for BPH, both with similar IPSS and QoL improvements. HoLEP excels in functional outcomes, particularly in improving Qmax and PVR. Conversely, WJAT, with its shorter operation time and hospital stays, presents a compelling alternative, particularly for outpatient settings.

Long-term patient clinical benefits and healthcare utilization after pulsed field ablation in paroxysmal atrial fibrillation: sub-analyses from the multicenter inspIRE trial

Abstract Background/Introduction The treatment of atrial fibrillation (AF) with pulsed field ablation (PFA) aims to prevent AF recurrence while reducing complications from the ablation modality. Similar to thermal ablation, PFA has proven to be safe and effective for treatment of paroxysmal AF (PAF); however, there is scarce evidence on patient-related clinical benefits, including healthcare utilization, using this new energy modality. Purpose The objective of this study is to assess long-term clinical improvements in patient care, symptoms, and quality-of-life (QOL) after PFA ablation in PAF. Methods InspIRE was a multicentre study evaluating the safety and efficacy of variable loop PFA catheters integrated with a 3D mapping system for treatment of symptomatic PAF. Patients were followed for up to 12 months for the following QOL and healthcare utilization endpoints: Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score, Class I/III AAD utilization, repeat ablation, incidence of direct current cardioversion (DCCV), and cardiovascular (CV) hospitalization. Post-hoc Kaplan-Meier estimates for clinical benefit success at 12 months were provided. Success was defined as composite freedom from occurrence of the following events post-blanking: repeat ablation, CV hospitalization, AAD utilization, and DCCV post-blanking. Predictors of clinical benefit success were explored via multivariate logistic regression analysis. Results A total of 186 enrolled patients (59±10 years; 70.0% male; CHA2DS2-VASC score 1.3±1.2) underwent PVI. Compared to baseline: 1) improvements in the AFEQT composite score were seen at 12 months (P&amp;lt;0.001); 2) Class I/III AAD use was reduced from 81.7% to 20.1% at 6-12 months (P&amp;lt;0.05); and 3) the proportion of subjects with DCCV decreased from 13.7% up to 12 months before the index procedure to 3.3% up to 12 months after the index procedure (P&amp;lt;0.001, Figure 1). Minimal clinically important difference in QoL (≥5 points improvement in AFEQT) was achieved in 85.2% of patients. Patients free from 12-month AF/AT/AFL recurrence (asymptomatic and symptomatic) had significantly greater improvements in AFEQT scores from baseline to 12 months versus those with recurrence (P=0.01). The clinical benefit success rate at 12 months was 87.5% (Figure 2). Patients who failed the clinical benefit endpoint were counted, including those with repeat ablation (7.5%), those on new or higher dose of AAD (6.5%), those hospitalized for CV (4.8%), and those who had DCCV post-blanking (1.6%). Multivariate logistic regression analysis showed that left ventricle ejection fraction &amp;lt;60% (OR: 0.22; 95% CI: 0.08-0.62; P&amp;lt;0.05) and incidence of diabetes (OR: 7.25; 95% CI: 2.00, 26.3; p&amp;lt;0.05) were associated with a higher risk of clinical benefit failure. Conclusions PFA ablation of PAF patients led to a clinical benefit success rate of 87.5%, with clinically meaningful improvement in QOL, as well as a reductions in AAD use, cardioversion, and hospitalization.Figure 1.Improvements in QoL and HealthFigure 2.Kaplan-Meier Analysis of Time

One-year results from the REDUCER-I multi-center real-world clinical trial of the treatment of refractory angina with the coronary sinus Reducer

Abstract Background/Introduction Patients with refractory angina have chronic symptoms due to reversible ischemia which are inadequately controlled with optimal medical therapy or interventional treatments. These patients suffer from a poor quality of life and place a significant strain on the health care system due to their frequent rehospitalizations. The coronary sinus (CS) Reducer is a stainless-steel hour-glass shaped mesh stent that creates a focal narrowing in the lumen of the CS resulting in improved microvascular resistance and redistribution of myocardial blood flow. Purpose The COSIRA randomized controlled trial showed the Reducer is a safe and effective treatment for refractory angina with patients having significant improvements in Canadian Cardiovascular Society (CCS) class and other measures of quality of life. The REDUCER-I post-market study evaluated the long-term outcomes with the Reducer in a large and challenging ‘real-world’ cohort. Methods REDUCER-I is a multicenter, non-randomized study conducted across 26 medical centers in Europe. At one year, device effectiveness was assessed by improvement in CCS grade as compared to baseline and device safety was assessed by Major Adverse Cardiac Events (MACE). Secondary endpoints included six-minute walk tests, EQ-5D-5L tests, and Seattle Angina Questionnaires (SAQ). Subjects were followed at 30 days, 6 months, and annually through five years. Results The as-treated population includes a total of 371 patients who received a Reducer implant (78.7% (292/371) male, 47.2% (175/371) diabetic, 73.9% (274/371) post-revascularization). The one-year Kaplan-Meier overall MACE rate post-implant was 7.1% (95% CI [4.9, 10.4]). There were nine deaths within the first 365 days, one death was due to unknown causes and eight deaths were adjudicated to as not being device- or procedure-related. At 12 months, 70.0% (205/293) of patients improved by ≥1 CCS class. At baseline, 72.2% (232/363) of patients were CCS class III/IV and this proportion decreased to 18.1% (54/298) at 12 months (P&amp;lt;0.0001). The patients’ baseline six-minute walk distance was 327.5±116.1m which improved by a mean of 30.8±81.8m at 12 months (p&amp;lt;.0001). In the year prior to Reducer implant, 33.3% (88/264) of the patients had at least one visit to the emergency department compared to 11.7% (31/264) in the year after Reducer implant (p&amp;lt;.0001). The significant improvements in CCS class and SAQ-QoL were sustained through 3 years (Figure). Conclusion In this 12-month analysis of the REDUCER-I study, patients with refractory angina treated with the CS Reducer had low MACE rates and showed significant and sustained improvements in angina, QoL, functional capacity, and need for rehospitalization.

The Role of 5-Phosphodiesterase Inhibitors (PDE-5I) in Current Benign Prostatic Hyperplasia Treatment: A Narrative Review.

Introduction: 5-phosphodiesterase inhibitors (PDE-5I) have been investigated as a treatment for urinary dysfunction for almost a decade. The general perception is that they play a significant role in managing lower urinary tract symptoms (LUTS), particularly those associated with benign prostatic hyperplasia (BPH). However, the specific biochemical processes by which PDE-5I repairs urinary function are still poorly understood and there is little instrumental evidence of significant improvement in urinary symptoms. Therefore, we explore the role of 5-phosphodiesterase inhibitors (PDE-5I) as complementary to the conventional treatment of symptomatic BPH; we provide the suggested biological procedures involved in the association between PDE-5 inhibitor use and improvement in LUTS; and we propose new approaches to this topic. Material and Methods: A systematic search for clinical trials, experimental studies, and systematic reviews was performed in electronic libraries (PubMed, EMBASE, Scopus) using the terms "benign prostate hypertrophy", "benign prostate hyperplasia", "lower urinary tract symptoms", "storage symptoms", "voiding symptoms", "bladder outlet obstruction" and the keywords "mechanism of action", "synergy", "PDE-5 inhibitor", "alpha1-adrenergic antagonist", "5-alpha-reductase inhibitors" in various combinations. There was no restriction on publication date. Results: To date, only a few randomized studies have been published in which the effect of the combination of a conventional drug for the treatment of symptomatic BPH and a PDE-5I was investigated. Almost all showed significant improvement in IPSS and QoL. Some studies showed significant improvements in maximum urine flow (Qmax) and postvoiding residual volume (PVR) with combination therapy compared with a single agent alone. Conclusions: PDE-5I seems effective in relieving symptoms of some BPH patients when administered as complementary to agents currently used to treat BPH. However, the mechanism of action of PDE-5 inhibitors in LUTS remains poorly understood and it is difficult to determine the specific subset of BPH patients who will benefit from the combination of PDE-5 inhibitors with the current treatment. Well-designed, sufficiently informative comparative studies focusing on specific target group profiles (age, urogenital parameters) are needed to define new therapeutic options.

Evaluation of health-related quality of life and adherence among pre-extensively drug-resistant tuberculosis patients receiving either Bedaquiline or Delamanid regimen at a teaching hospital in Eastern India

ABSTRACT Background: The foremost concern and challenge in managing drug-resistant tuberculosis is ensuring a high health-related quality of life (HRQoL). The effectiveness of pre-extensively drug-resistant (Pre-XDR) tuberculosis management hinges on patients adhering to therapy, a crucial factor in averting the development of drug-resistant strains, ultimately enhancing HRQoL. Methodology: This analytical longitudinal study spanned two years at a teaching hospital and involved collaboration between the Departments of Pharmacology and Pulmonary Medicine. A case record form was utilized to gather baseline data, encompassing patient demographics, medication details, WHO BREF HRQoL scores, and treatment adherence. Patients were classified as either adherent or nonadherent using three distinct criteria: the guidelines of the Revised National Tuberculosis Programme (RNTCP), the Morisky-Green-Levine Scale (MGLS), and the Batalla test. The sample size was determined based on 30% nonadherence rates from preliminary analysis of prior data, resulting in 86 patients included in the study. The association between the improvement of HRQoL score from the baseline with the predictor variables was assessed with a linear regression model. Comparison of nonadherence with the different predictors of the study population was assessed with binary logistic regression model. Results: Analysis of demographic data revealed no notable differences in age and BMI between the Bedaquiline and Delamanid groups. However, there was a gender-related difference in treatment distribution, with more men in the Bedaquiline group. Other factors, such as marital status, socioeconomic status, employment status, stigma/discrimination, comorbidity, and addiction, showed no significant differences between the groups. Comparing HRQoL scores at baseline and after six months showed substantial improvements in all domains, indicating a positive impact of the treatment. Linear regression analysis revealed a strong association between QoL improvement and adherence. Adherence patterns did not significantly differ between the two treatment groups, as assessed by various criteria. The patients with high stigma, newly diagnosed Pre-XDR cases, and the presence of adverse events had higher odds of nonadherence. Conclusion: This study highlights the substantial impact of Bedaquiline and Delamanid treatment on the HRQoL of Pre-XDR TB patients in Eastern India. Adherence to treatment plays a crucial role in improving QoL, and factors like stigma, newly diagnosed Pre-XDR patients, and adverse drug reactions influence adherence adversely. The findings emphasize the importance of patient support and education to enhance treatment outcomes.

Impact of prosthodontic rehabilitation on psychological status and quality of life in maxillectomy patients of coronavirus disease 2019-associated mucormycosis at a tertiary care center: A prospective clinical study

Aims: The study was aimed to evaluate the effect of prosthodontic rehabilitation on psychological status (PS) and quality of life (QoL) in maxillectomy patients of coronavirus disease 2019-associated mucormycosis (CAM). Settings and Design: The study was designed as a prospective and clinical study. Materials and Methods: Twenty-four CAM patients undergoing maxillectomy and subsequent prosthetic rehabilitation were included. The treatment involved surgical, intermediate, and definitive obturator delivery at various phases of healing. PS was assessed using the Hospital Anxiety and Depression Scale (HADS), QOL using the European Organization for Research and Treatment of Cancer QoL Questionnaire-Head and Neck Module (EORTC QLQ-HandN35), and the functioning of obturator was assessed utilising the Obturator Functioning Scale (OFS) at various time points: before maxillectomy (T1), 2 weeks after maxillectomy (T2), 2 weeks upon usage of intermediate obturator (T3), just before delivery of definitive obturator (T4), and 12 weeks after the usage of definitive obturator (T5). Statistical Analysis Used: Data were analyzed using a social science statistical analysis program (Stata 14.0; StataCorp LLC, Texas, USA). The significance level was chosen &lt;0.05. Shapiro–Wilk test was used to assess the normality of quantitative data. Student’s t-test was employed (α =0.05) to evaluate if the patient’s PS, QOL, and obturator function had changed over time. The Spearman correlation coefficient (α =0.05) was utilized to evaluate the correlation coefficient between PS, QOL, and obturator function seen at T3 and T5. Results: Out of 24 enrolled patients, nine were dropped out. HADS-anxiety score was the highest at T1 (18.6 ± 1.2) and HADS-depression score was the highest at T2 (18.8 ± 1.6). HADS scores decreased significantly (P = 0.001) after prosthetic rehabilitation. EORTC QLQ-HandN35 score was the highest at T2 (105.8 ± 29.5), with statistical significance (P = 0.001) after rehabilitation. OFS was the highest at T3 (51.9 ± 3.9) and lowest at T5 (25.4 ± 2.8). Conclusion: CAM and maxillectomy deliberately affects the PS and QOL. Prosthetic rehabilitation, psychological motivation, and education create greater improvement in PS and QOL. The progress in parameters showed an upward trend with good obturator quality over a period of time.

High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.

Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches). Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis. A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m2 (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05). CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches. The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes. NCT02969616.

Changes in quality of life and health across the first two years of the COVID-19 pandemic: A mixed methods, longitudinal study of older adults

The objective of this study was to identify shifts in older adults’ well-being over the first two years of the COVID-19 pandemic. Between March 2020 and April 2022, 76 adults aged 65+ from the upper Midwest participated in telephone interviews across five timepoints. Quantitative and qualitative questions focused on perceptions of QOL, physical health and mental health, as well as changes over the two years of interviews. Repeated measures ANOVAs indicated significant changes in self-reported QOL over time, but no significant changes to self-reported physical or mental health. Thematic content analysis revealed relevant themes for each content area. Findings provided a longitudinal view of changes in perceived QOL and health among older adults during the COVID-19 pandemic. Despite quantitative improvements in QOL and stability in health, qualitative themes indicated nuances impacts including challenges to physical activity and fluctuations in mental health and QOL.

Impact of hemispherotomy on quality of life and burden of caregivers in children and adolescents: a retrospective observational study.

To evaluate QOL and caregiver burden of children and teenagers submitted to hemispherotomy for pharmacoresistant epilepsy, by comparing pre and post-surgical intervention data. Retrospective analysis of pediatric patients submitted to surgical hemispherotomy before intervention (preOP) and their follow-up at 6months (6M PO) and 2years (2Y PO) after surgery. QOL was evaluated through the Quality of Life in Childhood Epilepsy (QVCE-50) questionnaire and caregiver burden, through the Zarit Burden Interview (ZBI) tool. Twenty-two patients were included in the study. Sixteen patients (72%) were classified as Engel I at 2Y PO follow-up. QVCE-50 scale showed improvement of total QOL at 2Y PO. In relation to QVCE-50-specific domains, there was an improvement in the physical domain and in the cognitive-education a decrease in psychological and a stabilization in social/familiar domain scores. The majority of caregivers classified their burden as mild to moderate, with no PO improvement. Hemispherotomy represents an effective seizure control treatment, as well as it contributes to improvement of QOL, particularly in the physical domain and in spite of children's physical and cognitive limitations. However, no improvement in caregiver burden was observed, probably due to the chronic condition of these patients, which might be worsened by social issues.

Randomized open-label study of second-generation antipsychotics for the treatment of schizophrenia: 104-week final results of the JUMPs study assessing treatment discontinuation, remission, and social functioning

BackgroundWe report the final results of treatment with aripiprazole, blonanserin, and paliperidone from the Japan Useful Medication Program for Schizophrenia (JUMPs), a 104-week naturalistic study.MethodsJUMPs was an open-label, three-arm, randomized, parallel-group, 104-week study. Patients aged ≥ 20 years with schizophrenia requiring antipsychotic treatment or a switch from previous therapy were enrolled. The primary endpoint was treatment discontinuation rate over 104 weeks. Secondary endpoints included remission rate, Personal and Social Performance (PSP), safety, Positive and Negative Syndrome Scale (PANSS), and quality of life (QOL; EuroQol-5 dimension).ResultsIn total, 251 patients received aripiprazole (n = 82), blonanserin (n = 85), or paliperidone (n = 84). Treatment discontinuation rates (aripiprazole, 80.5%; blonanserin, 81.2%; paliperidone, 71.4%) were not significantly different (p = 0.2385) among the treatment groups at 104 weeks; comparable outcomes were observed for endpoints, including remission (42.9%, 46.7%, and 45.8%), PANSS, and safety. In the overall cohort, while the improvement in the PSP total score at Week 104 was not significantly different from baseline, a significant improvement (p < 0.05) in QOL and total PANSS scores (including all subscales) was observed at Week 104 compared with baseline. Multivariable analysis identified a shorter disease duration and a higher chlorpromazine-equivalent antipsychotic dosage level (≥ 1000 mg) before switching to monotherapy as predictors of treatment discontinuation.ConclusionsThe 104-week treatment outcomes were comparable between groups; the overall trend of improvement in remission rate, safety, and QOL suggests the importance of continued treatment.Clinical trial registrationUMIN-Clinical Trials Registry UMIN000007942 (public release date: 14/05/2012).

Impacts of subjective cognitive decline and mild cognitive impairment on the effectiveness of an exercise intervention among community-dwelling (Pre)frail older adults

BackgroundSubjective cognitive decline (SCD) is prevalent in community-dwelling (pre)frail older adults. This study aimed to investigate whether baseline subjective cognitive decline (SCD) and mild cognitive impairment (MCI) impacted the effectiveness of an exercise intervention among (pre)frail older adults. MethodsThis is a post hoc analysis of a stepped-wedge cluster randomized trial among (pre)frail older adults across six communities. The intervention effectiveness was examined among (pre)frail older people among subgroups with normal cognition (n = 44), SCD (n = 58), or MCI (n = 30). ResultsThe normal cognition group had both immediate and persistent treatment responses to most outcomes. The SCD group showed positive responses to frailty (0-, 12-, 24 week), ambulation and dynamic balance (0-week), and depressive symptoms (12-week). The MCI group exhibited immediate improvement in frailty, cognition, depressive symptoms, social support and QoL, which persisted only in frailty status, social support and mental QoL at follow-ups. The MCI group showed superior immediate responses to cognitive function and depressive symptoms compared to another two subgroups. No differences were found between the normal cognition and SCD groups except for cognitive status (12-week). Conclusions(Pre)frail people with SCD or MCI had fewer improved outcomes compared to those with normal cognition regardless of immediate or persistent improvements. The incorporation of cognitive strategies with exercise interventions are recommended among (pre)frail older adults with SCD or MCI.

Quality of life in patients with heart failure and implantable cardioverter defibrillator. Results from 42 heart failure clinics in norway

Abstract Background Patients with heart failure (HF) have an increased risk of sudden cardiac death, and treatment with an implantable cardioverter defibrillator (ICD) has become standard treatment for selected patient groups. HF is associated with impaired QoL, but there is no consensus regarding the implication of having an ICD. Knowledge regarding QoL in patients with HF and ICD attending follow-up in outpatient HF-clinics is sparse. Purpose The aim of this study was to determine QoL in patients with HF and ICD. Further, to compare QoL in patients with HF with and without ICD, using data from the first and follow-up visits in outpatient HF clinics. Methods Longitudinal data from the National Norwegian Heart Failure Registry (NNHFR), including 9 274 patients, of which 1 206 with an ICD, were studied. QoL was assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Data was collected at the first and follow-up visits in outpatient HF clinics approximately six months after optimal treatment was achieved. Results Patients with an ICD were younger, more often men, and had higher frequency of coronary artery disease (all p&amp;lt;0.001). At the first visit, there was no significant difference in QoL between patients with and without ICD, with both groups reporting moderate QoL. Both groups had a significant improvement in QoL from the first visit to the follow-up visit (p&amp;lt;0.001). However, patients with ICD reported significantly less improvement in QoL (p&amp;lt;0.001) at follow-up. This disparity was evident regarding both the physical (p&amp;lt;0.001) and the emotional (p&amp;lt;0.001) dimension. Conclusion QoL in patients with HF and ICD improves after follow-up in outpatient HF clinics, although not to the same extent as in patients without ICD. Thus, tailored interventions in outpatient HF clinics may be necessary to improve outcomes in this subgroup of patients with both HF and ICD.

Comparative evaluation of the effectiveness of balneotherapy and balneotherapy in combination with intravenous laser irradiation of blood at the period of spa treatment of patients with psoriasis

Background. Psoriasis is one of the most common, chronic, recurrent dermatoses. To date, a sufficient pool of studies has been accumulated confirming the multifactorial genesis of psoriasis due to genetic and environmental factors. Aim. Сomparative assessment of the effect of different options for spa treatment (ST) balneotherapy and balneotherapy in combination with intravenous laser blood irradiation (ILBI) in patients with psoriasis vulgaris on the level of IL-6 and IL-17, dermatological and psycho-emotional status, assessment of quality of life. Methods. The comparative study involved 108 patients with psoriasis vulgaris, stationary stage (men — 57.4%, women — 42.6%; the average age was 36.2 [24.5; 47.9] years) who underwent spa treatment, which were subsequently divided into 2 groups: 52 patients who received balneotherapy along with the traditional complex of ST were included in the 1 group, 56 patients who received complex treatment were included in the 2 group. The effectiveness of ST was evaluated using the PASI index, the HARS and HDRS scale, the SF-36 questionnaire. The dynamics of IL-6 and IL-10 levels in blood plasma were evaluated. The total duration of the study was 6 months and 14 days: the treatment phase was 14 days and the follow-up phase was 3 and 6 months after the completion of ST. Results. After 14 days of ST in the group in which balneotherapy was performed in combination with IVBI, a statistically significant decrease in the PASI index was more pronounced compared to the group in which balneotherapy was performed (p). Balneotherapy did not have a pronounced effect on psychoemotional status. On the contrary, balneotherapy in combination with ILBI contributed to a statistically significant decrease in the final indicators on the HARS and HDRS scales. The decrease in IL-6 and IL-17 levels was statistically significant in both groups and there were no differences between them. The complex use of balneotherapy and ILBI in comparison with the group of balneotherapy was accompanied by a more pronounced improvement in QOL. The combined use of balneotherapy and ILBI in the follow-up phase showed a long-term positive effect: 6 months after the completion of ST, the number of patients who had clinical remission was statistically significantly higher compared to the group in which balneotherapy was performed (87.4 vs. 44.7%). Conclusion. The advantage of the combined use of balneotherapy and ILBI compared with balneotherapy in patients with psoriasis vulgaris on CL was shown. The complex use of balneotherapy and ILBI of significant indicators of inflammatory biomarkers, improvement of the dermatological and psycho-emotional state, quality of life parameters and good overpopulation. More pronounced effectiveness of the complex use of balneotherapy and ILBI compared to balneotherapy of the quality, diversity of pathophysiological mechanisms of psoriasis and the presence of several targets for pathogenetic therapy.

Proposal and validation of a new approach in tele-rehabilitation with 3D human posture estimation: a randomized controlled trial in older individuals with sarcopenia

ObjectiveThrough a randomized controlled trial on older adults with sarcopenia, this study compared the training effects of an AI-based remote training group using deep learning-based 3D human pose estimation technology with those of a face-to-face traditional training group and a general remote training group.MethodsSeventy five older adults with sarcopenia aged 60–75 from community organizations in Changchun city were randomly divided into a face-to-face traditional training group (TRHG), a general remote training group (GTHG), and an AI-based remote training group (AITHG). All groups underwent a 3-month program consisting of 24-form Taichi exercises, with a frequency of 3 sessions per week and each session lasting 40 min. The participants underwent Appendicular Skeletal Muscle Mass Index (ASMI), grip strength, 6-meter walking pace, Timed Up and Go test (TUGT), and quality of life score (QoL) tests before the experiment, during the mid-term, and after the experiment. This study used SPSS26.0 software to perform one-way ANOVA and repeated measures ANOVA tests to compare the differences among the three groups. A significance level of p < 0.05 was defined as having significant difference, while p < 0.01 was defined as having a highly significant difference.Results(1) The comparison between the mid-term and pre-term indicators showed that TRHG experienced significant improvements in ASMI, 6-meter walking pace, and QoL (p < 0.01), and a significant improvement in TUGT timing test (p < 0.05); GTHG experienced extremely significant improvements in 6-meter walking pace and QoL (p < 0.01); AITHG experienced extremely significant improvements in ASMI, 6-meter walking pace, and QoL (p < 0.01), and a significant improvement in TUGT timing test (p < 0.05). (2) The comparison between the post-term and pre-term indicators showed that TRHG experienced extremely significant improvements in TUGT timing test (p < 0.01); GTHG experienced significant improvements in ASMI and TUGT timing test (p < 0.05); and AITHG experienced extremely significant improvements in TUGT timing test (p < 0.01). (3) During the mid-term, there was no significant difference among the groups in all tests (p > 0.05). The same was in post-term tests (p > 0.05).ConclusionCompared to the pre-experiment, there was no significant difference at the post- experiment in the recovery effects on the muscle quality, physical activity ability, and life quality of patients with sarcopenia between the AI-based remote training group and the face-to-face traditional training group. 3D pose estimation is equally as effective as traditional rehabilitation methods in enhancing muscle quality, functionality and life quality in older adults with sarcopenia.Trial registrationThe trial was registered in ClinicalTrials.gov (NCT05767710).