36-Item Short Form Health Survey Research Articles

Assessment of pain relief after four botulinum toxin A injection cycles in patients with post-stroke lower limb spasticity: A prospective, observational study

IntroductionSpasticity is common after a stroke and is an independent risk factor for developing pain. BotulinumtoxinA injection is the treatment of choice for focal spasticity. We examined the effect of intramuscular botulinumtoxinA on pain relief in patients in routine clinical practice who were experiencing pain as a primary complaint associated with post-stroke lower limb spasticity. MethodsProspective, multicentre, post-marketing observational study. The study period was 16 months. The primary effectiveness variable was the mean change from baseline on the pain 0–10 Numerical Rating Scale after four botulinumtoxinA injection cycles. Secondary endpoints included changes from baseline on the pain 0–100 Visual Analogue Scale, Goal Attainment Scale, modified Ashworth Scale, 10-Meter Walk Test, Penn Spasm Frequency Scale, and 36-item Short-Form Health Survey. ResultsOf 186 enrolled patients, 180 (96.8%) received botulinumtoxinA at least once. The mean (standard deviation) pain 0–10 Numerical Rating Scale score decreased significantly (p<0.0001) from 4.9 (2.2) at baseline to 2.5 (2.1) at study end, representing a 50% decrease in pain severity. Relief of pain due to spasticity was supported by improvement from baseline in all secondary variables except the 10-Meter Walk Test. Two adverse events (erysipelas and phlebitis) in one patient were considered likely to be related to botulinumtoxinA injection. ConclusionBotulinumtoxinA appears to provide pain relief as an additional benefit of local treatment in patients with post-stroke lower limb spasticity for whom pain relief is a primary therapeutic goal (a Lay Abstract has been provided as Appendix A).

The psychosocial impact of prostate cancer screening for BRCA1 and BRCA2 carriers.

To report the long-term outcomes from a longitudinal psychosocial study that forms part of the 'Identification of Men with a genetic predisposition to ProstAte Cancer: Targeted Screening in men at higher genetic risk and controls' (IMPACT) study. The IMPACT study is a multi-national study of targeted prostate cancer (PrCa) screening in individuals with a known germline pathogenic variant (GPV) in either the BReast CAncer gene 1 (BRCA1) or the BReast CAncer gene 2 (BRCA2). Participants enrolled in the IMPACT study were invited to complete a psychosocial questionnaire prior to each annual screening visit for a minimum of 5 years. The questionnaire included questions on sociodemographics and the following measures: Hospital Anxiety and Depression Scale, Impact of Event Scale, 36-item Short-Form Health Survey, Memorial Anxiety Scale for PrCa, Cancer Worry Scale, risk perception and knowledge. A total of 760 participants completed questionnaires: 207 participants with GPV in BRCA1, 265 with GPV in BRCA2 and 288 controls (non-carriers from families with a known GPV). We found no evidence of clinically concerning levels of general or cancer-specific distress or poor health-related quality of life in the cohort as a whole. Individuals in the control group had significantly less worry about PrCa compared with the carriers; however, all mean scores were low and within reported general population norms, where available. BRCA2 carriers with previously high prostate-specific antigen (PSA) levels experience a small but significant increase in PrCa anxiety (P = 0.01) and PSA-specific anxiety (P < 0.001). Cancer risk perceptions reflected information provided during genetic counselling and participants had good levels of knowledge, although this declined over time. This is the first study to report the longitudinal psychosocial impact of a targeted PrCa screening programme for BRCA1 and BRCA2 carriers. The results reassure that an annual PSA-based screening programme does not have an adverse impact on psychosocial health or health-related quality of life in these higher-risk individuals. These results are important as more PrCa screening is targeted to higher-risk groups.

Does botulinum toxin affect psycho-social aspects in dystonia?

Dystonia is a movement disorder in which sustained muscle contractions give rise to abnormal postures or involuntary movements. It is a disabling and disfiguring disorder that affects activities of daily living and gives people a bizarre appearance often associated with psychological morbidity, embarrassment and social avoidance. Intramuscular injection of botulinum toxin (BoNT) is the most effective treatment for motor symptoms in focal dystonia, but little is known about its impact on the psycho-social dimension. The main aim of this study was to evaluate psycho-social changes in patients with focal dystonia after starting BoNT treatment using self-reported scales. The Beck Depression Inventory (BDI-II), the 36-Item Short Form Health Survey (SF-36), the Body Uneasiness Test (BUT), the State-Trait Anxiety Inventory (STAI) and the Visual Analogue Scale (VAS) assessing body self-image, satisfaction with physical aspects, social avoidance, self-reported depression, and self-distress were completed by 11 patients with dystonia and 9 patients with hyperhidrosis as a control group before BoNT (T0). VAS was then performed after four weeks (T1) to assess whether BoNT induced changes in the psychosocial dimension. Our results showed that only depressive symptoms and rumination about body defects improved in patients with dystonia after BoNT treatment, while improvement in self-distress and satisfaction with physical aspects was also found in hyperhidrosis. Individuals with hyperhidrosis experience poorer psychological well-being and suffer from higher levels of distress compared to dystonic patients. This suggests that individuals with this disabling condition are more vulnerable to social impact than dystonic patients.

Study protocol for “Psilocybin in patients with fibromyalgia: brain biomarkers of action”

BackgroundChronic pain is a leading cause of disability worldwide. Fibromyalgia is a particularly debilitating form of widespread chronic pain. Fibromyalgia remains poorly understood, and treatment options are limited or moderately effective at best. Here, we present a protocol for a mechanistic study investigating the effects of psychedelic-assisted-therapy in a fibromyalgia population. The principal focus of this trial is the central mechanism(s) of psilocybin-therapy i.e., in the brain and on associated mental schemata, primarily captured by electroencephalography (EEG) recordings of the acute psychedelic state, plus pre and post magnetoencephalography (MRI).MethodsTwenty participants with fibromyalgia will complete 8 study visits over 8 weeks. This will include two dosing sessions where participants will receive psilocybin at least once, with doses varying up to 25mg. Our primary outcomes are 1) Lempel-Ziv complexity (LZc) recorded acutely using EEG, and the 2) the (Brief Experiential Avoidance Questionnaire (BEAQ) measured at baseline and primary endpoint. Secondary outcomes will aim to capture broad aspects of the pain experience and related features through neuroimaging, self-report measures, behavioural paradigms, and qualitative interviews. Pain Symptomatology will be measured using the Brief Pain Inventory Interference Subscale (BPI-IS), physical and mental health-related function will be measured using the 36-Item Short Form Health Survey (SF-36). Further neurobiological investigations will include functional MRI (fMRI) and diffusion tensor imaging (changes from baseline to primary endpoint), and acute changes in pre- vs post-acute spontaneous brain activity – plus event-related potential functional plasticity markers, captured via EEG.DiscussionThe results of this study will provide valuable insight into the brain mechanisms involved in the action of psilocybin-therapy for fibromyalgia with potential implications for the therapeutic action of psychedelic-therapy more broadly. It will also deliver essential data to inform the design of a potential subsequent RCT.

Postoperative Negative Pain Thoughts and Their Correlation With Patient-Reported Outcomes After Arthroscopic Rotator Cuff Repair: An Observational Cohort Study

Background: Pain and pain perception are influenced by patients’ thoughts. The short form Negative Pain Thoughts Questionnaire (NPTQ-SF) can be used to quantify unhelpful negative cognitive biases about pain, but the relationship between NPTQ-SF scores and orthopaedic surgery outcomes is not known. Purpose/Hypothesis: The purpose was to assess the relationship between negative pain thoughts, as measured by the NPTQ-SF, and patient-reported outcomes in patients undergoing arthroscopic rotator cuff repair, as well as to compare NPTQ-SF scores and outcomes between patients with and without a history of chronic pain and psychiatric history. It was hypothesized that patients with worse negative pain thoughts would have worse patient-reported outcomes. Study Design: Cohort study; Level of evidence, 2. Methods: In total, 109 patients undergoing arthroscopic rotator cuff repair were administered the 4-item NPTQ-SF, 12-item Short Form Health Survey (SF-12), American Shoulder and Elbow Surgeons (ASES) Shoulder Evaluation Form, and visual analog scale pain survey preoperatively between July 2021 and August 2022. The same surveys were completed ≥6 months postoperatively by 74 patients confirmed to have undergone arthroscopic rotator cuff repair. Results: Preoperative NPTQ-SF scores did not show any correlation with the postoperative patient-reported outcomes measured in this study. Postoperative NPTQ-SF scores were statistically significantly negatively correlated with postoperative SF-12 Physical Health Score, SF-12 Mental Health Score, ASES, and satisfaction scores (P < .05). Postoperative NPTQ-SF scores were statistically significantly positively correlated with postoperative visual analog scale scores (P < .001). Moreover, postoperative NPTQ-SF scores were statistically significantly negatively correlated with achieving a Patient Acceptable Symptom State and the minimal clinically important difference on the postoperative ASES form (P < .001 and P = .009, respectively). Conclusion: Postoperative patient thought patterns and their perception of pain are correlated with postoperative outcomes after rotator cuff repair. This correlation suggests a role for counseling and expectation management in the postoperative setting. Conversely, preoperative thought patterns regarding pain, as measured by the NPTQ-SF, do not correlate with postoperative patient-reported outcome measures. Therefore, the NPTQ-SF should not be used as a preoperative tool to aid the prediction of outcomes after rotator cuff repair.

How well do we measure the impact of bowel dysfunction on health-related quality of life after rectal cancer surgery?

BackgroundRectal cancer surgery risks causing bowel dysfunction, which has an important impact on health-related quality of life. The validity of generic tools used to measure health-related quality of life after bowel dysfunction is unclear. This study aims to determine the content validity of health-related quality-of-life measurement tools in rectal cancer. MethodsThis was a qualitative single-center study in which adult patients who underwent rectal cancer surgery with sphincter preservation from July 2017 to October 2020 were recruited. Patients were excluded if they developed local metastasis, required a permanent stoma, or had surgery <1 year since recruitment. Telephone-based semi-structured interviews were conducted. Bowel dysfunction was measured using the Low Anterior Resection Syndrome score. Content analysis was achieved using the International Classification of Functioning framework. ResultsRecurrent bowel dysfunction-related concepts included “Mental functions,” “Defecation functions,” “Emotional functions,” “Recreation and leisure,” “Intimate relationships,” and “Remunerative employment.” A mean of 7.5 recurrent bowel dysfunction-related concepts were identified within the health-related quality of life instruments analyzed. The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-C30 (n = 11) and the 36-Item Short Form Health Survey (n = 9) covered the greatest number of recurrent bowel dysfunction-related concepts. Concepts such as “Mental functions,” “Urination functions,” “Sexual functions,” “Driving,” and “Mobility” were not covered by any instrument. ConclusionThe content of traditional health-related quality-of-life instruments is missing important areas that represent the impact of bowel dysfunction after rectal cancer surgery on health-related quality of life. These findings could help improve patient-centered care in rectal cancer surgery.

Central sensitization significantly deteriorates functionality and the interpretation of self-reported disease activity in primary Sjögren's syndrome.

Central sensitization has a major role in health-related parameters in musculoskeletal conditions. There is still a lack of understanding regarding the impact of central sensitization on the interpretation of disease activity and functional disability in primary Sjögren's syndrome (pSS). The Central Sensitization Inventory (CSI) was used to screen for central sensitization. Disease-related parameters, including objective tests, medication use, the EULAR SS Patient Reported Index (ESSPRI), and the EULAR SS Disease Activity Index (ESSDAI), were assessed. Functionality, quality of life, sleep, and mental health were evaluated by the Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Jenkins Sleep Evaluation Scale (JSS), and Hospital Anxiety and Depression Scale (HADS), respectively. The effect of central sensitization on functionality and disease activity measures was assessed by regression analyses. The frequency of central sensitization was 65% in patients with pSS (n = 60). Patients with central sensitization had higher HAQ-DI, ESSPRI, HADS, and JSS and lower SF-36 subdomain scores (p < 0.05 for all). A significant positive correlation was observed between the CSI scoreand theESSPRI, JSS, HAQ-DI, and HADS scores (Spearman's rho ranging from 0.342 to 0.739). The multiple regression analysis indicated that CSI was independently associated with HAQ-DI (adjusted R2 = 0.19, B = 0.01) and ESSPRI (adjusted R2 = 0.45, B = 0.08) (p < 0.001 for all). This study confirms that central sensitization has a major impact on functionality and the interpretation of self-reported disease activity in pSS. When devising strategies for the management of patients with pSS, it is crucial to consider these close relationships. Key Points • The frequency of central sensitization accompanying primary Sjögren's syndrome is considerable. • Central sensitization was independently associated with functionality and self-reported disease activity assessment. • This close association leads to challenges in functionality, evaluating treatment response, and planning or switching between therapies in primary Sjögren's syndrome.

Autologous osteoperiosteal transplantation is effective in the treatment of single cystic osteochondral lesions of the talus and the prognostic impact of age should be emphasized.

To investigate the clinical efficacy and prognostic factors associated with autologous osteoperiosteal transplantation for the treatment of single cystic osteochondral lesions of the talus (OLT). The clinical data of patients with single cystic OLT undergoing autologous osteoperiosteal transplantation at the Department of Foot and Ankle Surgery of our hospital between 2018 and 2022, including complete follow-up, were retrospectively analyzed. Imaging data from each patient were imported into Mimics software to measure the surface area, volumeand depth of the lesions. Then, the talus nine-compartment partitioning method was used to partition the injury site. Preoperative and final follow-up assessments were performed using the American Orthopaedic Foot and Ankle Society (AOFAS) score, visual analogue scale (VAS) for painand 36-item Short-Form Health Survey (SF-36) to evaluate treatment efficacy and analyze prognostic factors. Of the 31 patients with single cystic OLT with a complete set of follow-up data, there were 17 males and 14 females, with a mean age of 43.3 ± 13.6 years, a mean follow-up time of 30.1 ± 14.0 monthsand a mean illness duration of 30.4 ± 20.0 months. The postoperative final follow-up AOFAS score was 90.7 ± 5.5; this represented significant improvement when compared to the preoperative score of 57.0 ± 8.5 (P < 0.001). The final postoperative follow-up VAS score was 18.5 ± 8.3; this was significantly better than the preoperative score of 57.8 ± 8.7 (P < 0.001). The physical component summary (PCS)score and mental component summary (MCS)score on the SF-36 scale showed significant improvement at the final postoperative follow-up when compared to preoperative scores (p < 0.001). No other complications were observed during follow-up, such as wound infection or pain at the donor site. One of the patients showed less improvement, which may be related to premature weight-bearing or re-sprained ankle after surgery. There was no significant correlation between the duration of illness, genderand the location, depth, surface areaand volume of the OLTand the postoperative scores. However, patient age showed a significant negative correlation with the postoperative SF-36 PCS and MCS scores. Autologous osteoperiosteal transplantation for single cystic OLT demonstrated good clinical efficacy with a low incidence of complications. Furthermore, age represents an important factor influencing prognosis. Level II.

Feasibility and Acceptability of a Health App Platform Providing Individuals With a Budget to Purchase Preselected Apps to Work on Their Health and Well-Being: Quantitative Evaluation Study.

The potential of health apps for health promotion and disease prevention is widely recognized. However, uptake is limited due to barriers individuals face in finding suitable and trustworthy apps, such as the overwhelming amount of available health apps. Therefore, the health app platform "FitKnip" was developed, enabling individuals to purchase preselected, trustworthy health apps with a budget of 100 euros (a currency exchange rate of EUR €1=US $1.0831 is applicable). The platform aimed to empower individuals to improve their health and vitality, ultimately supporting a more healthy society. The primary aim of this study was to evaluate the health app platform in terms of feasibility and acceptability. Potential effects on health empowerment and health outcomes were secondarily explored. This quantitative study was part of a mixed methods study with a prospective pre-post interventional design. We collected web-based user data, and self-reported web-based questionnaires were collected over 5 measurements over an 8-month period. Use statistics were tracked on the platform, including the number of purchased apps and euros spent per user registered within the health app platform. We measured the user-friendliness of the health app platform using the System Usability Scale (SUS) and satisfaction using the Client Satisfaction Questionnaire-8 (CSQ-8) and several 10-point Likert items. We asked participants to indicate, on a scale from 1 (not at all) to 10 (completely), how much the health app platform contributed to various areas related to health empowerment. We assessed health-related quality of life by the 12-item Short-Form Health Survey (SF-12) and one's perceived level of stress by the 10-item Perceived Stress Scale (PSS-10). A total of 1650 participants were included, of whom 42% (685/1650) bought at least 1 app. The majority of those purchased one app (244/685, 35.6%). The health app platform was rated as user-friendly (SUS mean 66.5, SD 20.7; range 66.5-70.0), and the acceptability of the health app platform was moderate (CSQ-8 mean 20.0, SD 1.5; range 19.6-20.0). Results furthermore showed that participants were generally satisfied to highly satisfied with the ease of the payment system to purchase apps on the platform (median 8, IQR 7-10), the look and feel of the platform (median 7, IQR 6-8), as well as the provided budget of 100 euros (median 9, IQR 7-10). Participants were less satisfied with the amount (median 6, IQR 4-7) and diversity (median 6, IQR 4-7) of apps offered on the platform. A health app platform is a promising initiative to enhance public health. Feasibility and acceptability are critical for success, as they ensure that such a platform is accessible, user-friendly, and meets end users' needs and preferences. This can help to increase uptake, engagement, and ultimately the platform's adoption and effectiveness.

Postoperative Dexmedetomidine Infusion and Chronic Postsurgical Pain in Thoracoscopic Pulmonary Nodule Surgery: A Retrospective Study with Propensity-Score-Matched Analysis.

Patients frequently suffer from debilitating chronic postsurgical pain (CPSP) subsequent to thoracoscopic surgery. The impact of postoperative dexmedetomidine infusion on CPSP remains elusive. This study aimed to scrutinize the effect of dexmedetomidine on both 1-year incidence of CPSP and the quality of recovery after thoracoscopic pulmonary nodule surgery. This retrospective analysis encompassed clinical and follow-up data from 1148 patients undergoing thoracoscopic pulmonary nodule surgery at our institution between September 2021 and August 2022. Depending on whether dexmedetomidine was infused intravenously or not on the first night after surgery, patients were stratified into the dexmedetomidine group or the control group, with propensity score matching applied to harmonize baseline characteristics. Comparative analysis sought to delineate distinctions of CPSP and recovery quality 1year after surgery. Following propensity score matching, a cohort of 258 patients in each group underwent analysis. Comparisonsafter matching revealed no statistically significant disparities in 1-year CPSP incidence [76/258 (29.5%) versus 78/258 (30.2%), P = 0.847], moderate-to-severe pain occurrence [17/76 (22.4%) versus 22/78 (28.2%), P = 0.405], neuropathic painoccurrence [11/76 (14.5%) versus 11/78 (14.1%), P = 0.948], and postoperative recovery quality assessed by 12-Item Short Form Health Survey (SF-12) score (113.1 [107.2, 116.0] versus 113.0 [107.4, 116.0], P = 0.328). Multivariate logistic regression analysis encompassing the entire cohort identified being female [odds ratio (OR) 2.10, 95% confidence interval (CI) 1.59-2.79, P < 0.001) and postoperative rescue analgesia (OR 1.47, 95% CI 1.09-1.96, P = 0.010) as risk factors for CPSP, while intraoperative fentanyl dosage (OR 0.92, 95% CI 0.87-0.98, P = 0.006) emerged as a protective factor. The prolonged administration of dexmedetomidine did not yield discernible amelioration in either 1-year CPSP or the recovery quality after thoracoscopic surgery. Noteworthy risk factors for CPSP encompassed female sex, postoperative rescue analgesia, and diminished fentanyl dosage intraoperatively.

The Relationships Among Family Functioning, Sleep Quality and Quality of Life in Chinese Community-Dwelling Older Adults with Insomnia: A Structural Equation Model

ABSTRACT Objectives The proportion of individuals with insomnia is increasing, and many older adults have insomnia. This study aimed to explore the relationships between family functioning and quality of life (QOL) among community-dwelling older adults with insomnia, as well as to explore the mediating role of sleep quality in this relationship. Methods The participants were 225 older adults with insomnia from community health service centers in Chongqing, China. The Family Care Index (APGAR) was used to assess family functioning, the Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality, and the 36-item Short-Form Health Survey (SF-36) was used to assess QOL. Results The results showed that family functioning would be positively associated with QOL (p = .005) and that this relationship would be partially mediated by higher sleep quality (p < .001). Conclusions Family functioning has a direct effect on QOL and an indirect effect on QOL through the regulation of sleep quality. Maintaining good family functioning is important for improving sleep quality and QOL in older adults with insomnia. Clinical Implications Developing family functioning-based assessments and targeted intervention strategies could be beneficial for older adults with insomnia.

P.134 Long-term quality of life deterioration in vestibular schwannoma patients treated with radiotherapy: a matched cohort with surveillance, radiation and surgery

Background: There is an absence of studies evaluating longitudinal quality of life (QoL) amongst vestibular schwannomas (VS) with matched tumor and patient characteristics between treatment groups. We present novel findings of 12 yearlong follow-up of patient QoL and symptomatology outcomes in this matched cohort study. Methods: Symptomatology and 36-Item Short Form Health Survey (SF36) between 2000-2017 in VS patients managed at a single tertiary centre was conducted. Radiation (R) and active surveillance (A) groups were matched for tumor size and age against the surgery (S) group. Results: 14 A patients, 24 R patients, 49 S patients met matching and inclusion criteria. Mean age, tumor diameter and follow up was 69.1 years, 21.6mm and 12.0 years respectively. Mental component summary (MCS) scores deteriorated significantly in the radiation group (3.1 S, 3.7 A, -3.5 R, p-value 0.008). Physical component summary scores remained stable at follow up (-0.2 S, 0.00 S, -4.0 R, p-value 0.227). Various symptoms resolved statistically in surgery goup, whereas tinnitus on follow up was higher with radiation (40.8% S, 66.7% R, p-value 0.038). Conclusions: Surgery group demonstrated improvements in long term QoL with good symptom resolution, whilst radiation group demonstrated small but significant deterioration over time.

Recovery and immune function after low pressure pneumoperitoneum during robot-assisted radical prostatectomy: a randomised controlled trial.

To compare the effectiveness of low intra-abdominal pressure (IAP) facilitated by deep neuromuscular block (NMB) to standard practice in improving the quality of recovery, preserving immune function, and enhancing parietal perfusion during robot-assisted radical prostatectomy (RARP). In this blinded, randomised controlled trial, 96 patients were randomised to the experimental group with low IAP (8 mmHg) facilitated by deep NMB (post-tetanic count 1-2) or the control group with standard IAP (14 mmHg) and moderate NMB (train-of-four 1-2). Recovery was measured using the 40-item Quality of Recovery questionnaire and 36-item Short-Form Health survey. Immune function was evaluated by plasma damage-associated molecular patterns, cytokines, and ex vivo lipopolysaccharide-stimulated cytokine production. Parietal peritoneum perfusion was measured by analysing the recordings of indocyanine-green injection. Quality of recovery was not superior in the experimental group (n = 46) compared to the control group (n = 50). All clinical outcomes, including pain scores, postoperative nausea and vomiting, and hospital stay were similar. There were no significant differences in postoperative plasma concentrations of damage-associated molecular patterns, cytokines, and ex vivo cytokine production capacity. The use of low IAP resulted in better parietal peritoneum perfusion. Despite better perfusion of the parietal peritoneum, low IAP facilitated by deep NMB did not improve the quality of recovery or preserve immune function compared to standard practice in patients undergoing RARP.

Long-term effects of catheter ablation versus antiarrhythmic drugs on health-related quality of life in patients with atrial fibrillation: the CAPTAF randomized clinical trial revisited

Abstract Background Data on long-term effects of catheter ablation versus antiarrhythmic drugs (AAD) on health-related quality of life (HRQoL) and atrial fibrillation (AF) burden are limited. The study aimed to assess long-term HRQoL and rhythm data in symptomatic AF patients. Methods The 75 patients who underwent ablation and 74 receiving AAD in the Catheter Ablation compared with Pharmacological Therapy for Atrial Fibrillation (CAPTAF) trial were followed for 48 months comparison of General Health using 36-Item Short-Form Health Survey, time to first AF-episode ≥1 hour, and AF burden, recorded by implantable cardiac monitors. Results 147 patients completed follow-up, with seven crossovers in the ablation group and 34 crossovers in the AAD group. General Health improved by ablation, median 62 points at baseline to 79.2 points at follow-up (p&amp;lt;0.001), and by AAD from median 67 to 77 points (p&amp;lt;0.001), without treatment differences (p=0.77). Time to first AF-episode ≥1 hour was longer, median 257 days (ablation group) versus 180 days (AAD group), p=0.025. The cumulative AF burden during follow-up was lower in the ablation (median 0.3% [interquartile range 0, 1.4]) versus AAD group (1.6% [0.1, 11.0]), p=0.01. The cumulative reduction in AF burden compared with baseline was greater in the ablation (median -89.5% [-98.4, -51.3]) versus AAD group (-52.7% [-92.6, 263.6]), p=0.001). Conclusions HRQoL improvement at long-term did not differ between ablation and AAD despite a larger reduction in AF burden after ablation. The results should be interpreted in the light of a four times higher crossover rate in the AAD group.

#2938 The association between serum iron biomarkers and health-related quality of life in patients undergoing dialysis

Abstract Background and Aims Anemia is a very common complication of chronic kidney disease, affecting most patients undergoing dialysis. Iron deficiency, one of the causes of anemia, is generally a second consideration in the management of anemia. Nephrologists mainly focus on the correction of hemoglobin, often prescribing iron therapy for this indication only. However, iron has important physiological functions besides erythropoiesis. Conversely, iron overload can lead to oxidative stress and cellular damage. Therefore, nephrologists have been cautious to prescribe iron therapy to patients with already high serum iron levels. This caution has been underscored by studies linking higher levels of iron to increased mortality. Unfortunately, evidence is lacking regarding the impact of iron on important patient-reported outcomes like health-related quality of life (HRQoL). Therefore, the aim of this study is to explore the association between serum iron biomarkers, health-related quality of life (HRQoL) and the presence of anemia-related symptoms over a one-year period in patients undergoing dialysis. Method Data were obtained from the multicenter, prospective, observational Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO). Adult patients new to dialysis were included, and had a baseline and follow-up assessments at 3, 6 and 12 months, with measurements of serum iron biomarkers ferritin and transferrin saturation (TSAT). HRQoL, encompassing physical and mental HRQoL, was measured using the validated 12-item Short Form Health Survey (SF12, summary scores ranging from 0 to 100). The presence of anemia-related symptoms: fatigue, shortness of breath, restless legs and muscle cramps were assessed using the Dialysis Symptom Index. Patients were categorized into 4 groups depending on their ferritin levels (μg/L): &amp;lt;200, 200–500 (reference), &amp;gt;500–700 and &amp;gt;700, and into 3 groups depending on their TSAT levels (%) at baseline: &amp;lt;20, 20–39 (reference), and ≥40. Longitudinal analyses were conducted using sequential conditional mean models to adjust for time-independent and time-varying confounding. All analyses captured the overall association over a one-year follow-up. Results We included 1069 patients, of whom 76% started hemodialysis, the median age was 68, 66% were male, and 32% were receiving iron therapy. Over a one-year follow-up, patients with ferritin &amp;lt;200 μg/L had similar physical HRQoL (MD=0.5 ; 95% CI –2.4 to 3.3 ) and mental HRQoL (MD=0.04 ; 95% CI -2.0 - 2.0) compared to the reference group with ferritin between 200–500 μg/L. Patients with ferritin between 501–700 μg/L also had a similar physical and mental HRQoL mental HRQoL compared to those with ferritin between 200-500 μg/L. This was also found for patients with ferritin above 700 μg/L (Fig. 1). Similarly, patients with TSAT levels below 20% and patients with TSAT levels ≥40% had comparable physical and mental HRQoL compared the reference group of patients with a TSAT between 20-39% (Fig. 2). For the secondary objectives, we found no significant differences in the anemia-related symptoms fatigue, shortness of breath, restless legs, or muscle cramps between patients with various levels of ferritin nor between the various TSAT groups. Conclusion We found that dialysis patients with higher or lower levels of ferritin or TSAT did not have a significantly different physical or mental HRQoL over a one year-follow up after starting dialysis. Similarly, no significant differences were found in the presence of fatigue, shortness of breath, restless legs, and muscle cramps between patients with these higher or lower levels of serum iron markers. And although iron levels do have impact on clinical outcomes such as mortality, these results suggest that they do not influence patient reported outcomes such as physical and mental HRQoL.

#2891 Comparing health-related quality of life and symptom burden in patients undergoing twice-weekly versus thrice-weekly haemodialysis

Abstract Background and Aims Patients with kidney failure who initiate haemodialysis (HD) have traditionally followed a thrice-weekly, 4-hour schedule. Recently, incremental dialysis (i.e. initiating HD with lower frequency and/or treatment duration) has been advocated. It has been suggested that residual kidney function is better preserved, while mortality is similar when initiating dialysis with a twice versus thrice weekly schedule. It remains unclear which impact initiating dialysis twice a week has on health-related quality of life (HRQoL) in the short and long term. Therefore, the aim of this study was first to investigate the impact of following a twice-weekly dialysis schedule on the mental and physical HRQoL and symptom burden compared to thrice-weekly dialysis during the first year of dialysis. Second, to investigate the long term impact on mental and physical HRQoL and symptom burden of patients who solely started on a twice-weekly versus thrice-weekly schedule. Method Data were obtained from the ongoing multicentre, prospective, observational Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO). This study longitudinally compares HRQoL between home and in-center dialysis. For this analysis, incident HD patients &amp;gt; 18 years were included, if they started on a twice-weekly or thrice-weekly schedule. Mental and physical HRQoL was measured using the validated 12-item Short Form Health Survey (SF12, summary scores ranging from 0 to 100). Symptom burden was measured using the dialysis symptom index (DSI), consisting of 30 items on dialysis-related symptoms, these symptoms are reported using a 5-point Likert scale. The overall burden score, ranging from 0 to 150, was calculated by summing every symptom and its severity. The first aim was longitudinally analysed using linear mixed models, using measures at 3, 6 and 12 months after start dialysis. The second aim was cross-sectionally analysed at 1, 2 and 3 years after dialysis initiation using linear regression models. All models were adjusted for possible confounders. Results A total of 1007 patients were included, of whom 205 started on a twice-weekly schedule and 802 on a thrice-weekly schedule. The total population had a mean age of 64 ± 15 years and 35% were women. There was no significant difference in baseline characteristics between twice-weekly and thrice-weekly dialysis. At baseline mental and physical HRQoL for patients on twice-weekly dialysis were 45.9 ± 9.5 and 36.0 ± 10.7, respectively. In thrice-weekly dialysis this was 45.8 ± 10.3 and 35.0 ± 9.7. The symptom burden score at baseline was 33.0 ± 19.6 for twice-weekly and 34.0 ± 21.7 for thrice-weekly patients. As shown in Table 1, there were no significant differences in HRQoL or symptom burden over the first year of dialysis when comparing twice-weekly with thrice weekly HD. In Table 2 the long-term cross-sectional analyses show that starting with a twice-weekly schedule results in physical and mental HRQoL scores gradually becoming lower, with a statistically significant decrease in physical HRQoL score at 3 years after start dialysis (ß = −0.825, 95% CI −14.11; −2.38). There was no significant difference in symptom burden between the two schedules. Conclusion We found no differences in HRQoL or symptom burden during the first year of dialysis comparing incident patients on a twice-weekly versus thrice-weekly hemodialysis schedule. Conversely, starting on a twice-weekly dialysis schedule appears to be associated with a lower HRQoL, especially physical HRQoL, in the longer term. Following our results, physicians should be cautious of the possible negative effects on HRQoL when prescribing a twice-weekly dialysis schedule.

#1171 Effect of methoxy polyethylene glycol-epoetin beta on delaying dialysis in anemic patients with Stage 4-5 chronic kidney disease

Abstract Background and Aims The optimal hemoglobin (Hb) target for treating anemia in pre-dialysis chronic kidney disease (CKD) remains controversial. This study investigates the efficacy and safety of methoxy polyethylene glycol-epoetin beta, in delaying the initiation of kidney replacement therapy (KRT), all-cause mortality, CKD progression, and quality of life in stage 4-5 CKD patients. It compares outcomes between patients targeting an Hb level of 10.5-11.5 g/dL versus 8.5-9.5 g/dL. Method This was a single-center, open-label, parallel-group randomized controlled trial. Patients with estimated glomerular filtration rates (eGFR) of 8-15 ml/min/1.73 m2, who had not yet started dialysis, were randomized into two groups based on different Hb targets (Group A: 10.5-11.5 g/dL, Group B: 8.5-9.5 g/dL). Methoxy polyethylene glycol-epoetin beta (MIRCERA®) was prescribed by a pre-specified protocol to achieve these Hb targets. Iron supplements were administered to maintain transferrin saturation &amp;gt;20% or serum ferritin &amp;gt;200 ng/ml. Primary outcomes included a composite of all-cause death and KRT initiation, with secondary outcomes encompassing eGFR slope, hospitalization incidence, blood transfusion necessity, and quality of life measured by the 36-Item Short Form Health Survey (SF-36). Results A total of 62 participants were randomized. The mean age was 64.0 years (SD ±16.0), with 51.6% being female. The mean estimated Glomerular Filtration Rate (eGFR) at enrollment was 12.1 ml/min/1.73 m2 (SD ±3.1). Group A had a significantly higher time-averaged Hemoglobin (Hb) level (10.5 g/dL, SD ±1.2) compared to 8.5 g/dL (SD ±0.9) in the control group (p &amp;lt; 0.001). There was no significant difference in the composite endpoint of all-cause death and Kidney Replacement Therapy (KRT) initiation between the two groups (Hazard Ratio [HR] 0.69; 95% Confidence Interval [CI] 0.32-1.50; p = 0.35, as shown in the Figure). The eGFR slope was similar in both groups (−2.54 vs. −2.53 ml/min/1.73 m2 per year, p = 0.9). Time-averaged ferritin, transferrin saturation, blood pressure, and dietary sodium/protein intake showed no significant differences. Participants in the lower Hb target group required more blood transfusions (11 vs 1 unit, Incidence Rate Ratio [IRR] = 0.075, 95% CI 0.002-0.517, p = 0.001). Rates of hospital admissions, and changes in SF-36 quality of life domains were comparable between the groups, as detailed in the Table. Conclusion The study indicates that using methoxy polyethylene glycol-epoetin beta to maintain a higher Hb target in anemic patients with stage 4-5 CKD does not significantly alter the rate of all-cause mortality, the initiation of KRT, and rate of eGFR decline compared to a lower Hb target. However, a higher Hb target may reduce the need for blood transfusions without adversely affecting the progression of CKD, hospitalization rates, or quality of life. These findings suggest that while higher Hb targets may not dramatically alter key clinical outcomes, they could offer benefits in reducing transfusion requirements, thus providing a more nuanced approach to managing anemia in late-stage CKD.

Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study

BackgroundTumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naïve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients.MethodsThe phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for ≥ 6 months; active disease (≥ 3 swollen, ≥ 3 tender joints, C-reactive protein ≥ 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo→guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator’s Global Assessment (IGA) of psoriasis score of 0/1 plus ≥ 2-grade reduction and ≥ 90% improvement in Psoriasis Area and Severity Index (both among patients with ≥ 3% body surface area affected by psoriasis and baseline IGA ≥ 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided α = 0.05. Cochran-Mantel–Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively.DiscussionFindings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA.Trial registrationThis trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021.

OPerative versus non-opERAtive management of isolated ULNAr diaphyseal fractures (OPERA-Ulna): protocol for a randomized controlled trial.

Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury. This trial has been approved by the lead site Conjoint Health Research Ethics Board (CHREB; REB14-2004) and local ethics boards at each participating site. Findings from the trial will be disseminated through presentations at regional, national, and international scientific conferences and public forums. The primary results and secondary findings will be submitted for peer-reviewed publication.

Therapeutic effect and psychological impact of aspirin plus edaravone on patients with cerebral infarction.

Cerebral infarction (CI) is characterized by a high prevalence, disability, and mortality. Timely or improper treatment greatly affects patient prognosis. To explore the drug efficacy of aspirin plus edaravone and to explore their effect on quality of life (QOL), anxiety and depression in CI patients. We retrospectively analyzed the records of 124 CI patients treated between June 2019 and February 2021 who were assigned to an observation group (OG) (combination therapy of aspirin and edaravone, 65 patients) or a control group (CG) (aspirin monotherapy, 59 patients). The therapeutic effects, pre- and posttreatment National Institutes of Health Stroke Scale (NIHSS) scores, activities of daily living, degree of cognitive impairment, protein levels of glial fibrillary acidic protein (GFAP), neuron-specific enolase (NSE) and S-100B, occurrence of adverse reactions, and serum high-sensitivity C-reactive protein (hs-CRP), interleukin (IL)-6 and tumor necrosis factor (TNF)-α were evaluated, detected and compared between the two groups. Finally, posttreatment QOL, anxiety, and depression were assessed by the Medical Outcomes Study 36- Item Short Form Health Survey Scale, Self-rating Depression Scale (SDS), and Self-rating Anxiety Scale (SAS), respectively. Compared with the CG, the OG had markedly better therapeutic effects, greater improvements in activities of daily living, and better alleviation in cognitive dysfunction after treatment, as well as lower posttreatment NIHSS scores and serum NSE, GFAP, S-100B, hs-CRP, IL-6, and TNF-α levels; the OG was similar to the CG in terms of adverse reactions but was better than the CG in terms of posttreatment QOL; and the OG also had lower SDS and SAS scores than the CG after treatment. Aspirin plus edaravone had a good curative effect on CI. It can reverse cranial nerve damage in patients, improve neurological function and prognosis, and alleviate inflammation, anxiety, and depression; thus, it is considered safe and worthy of clinical application.