Search

Sleep disorders are relatively common among patients with inflammatory arthritis (IA) and have a substantial impact on their quality of life. Although patients frequently recognize poor sleep as an important component of their disease, dyssomnias remain often underdiagnosed and untreated in routine clinical practice. This narrative review examines the prevalence, mechanism, risk factors and management of dyssomnias in rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). Relevant articles were retrieved from PUBMED, Scopus and DOAJ. The pathomechanism of sleep disorders in IA is multifactorial and partially differs in RA, axSpA and PsA, however, comparative studies are lacking. Various factors affecting sleep quality, including disease activity, pain, mood disorders, fatigue and female gender, have been examined, but their interplay complicates establishing clear causal relationships. The bidirectional link between sleep quality and rheumatic disease activity highlights the complexity of this issue and demonstrates the importance of holistic management of rheumatic patients. Both pharmacological (e.g., hypnotics, NSAIDs, antidepressants, cannabidiol) and non-pharmacological (e.g., psychotherapy, physical activity) interventions for improving sleep were analyzed. Additionally, questionnaires currently used for assessing sleep were discussed. This review aims to provide a comprehensive overview of sleep disorders across the three most common types of IA, emphasizing the need to develop reliable and patient-friendly tools for everyday clinical practice and further comparative research. [ABSTRACT FROM AUTHOR]

Background: Knee arthroplasty procedures improve pain, function, stability, and appearance of the limb. Total knee arthroplasty (TKA) in severe, long-standing osteoarthritis (OA) with large medial tibial defects could be a challenge. This paper looks at TKA outcomes when large tibial defects are managed without metal wedges or stems.Methods: TKA cases done for OA with tibial defects of 15-25 mm, without any metal wedge or stem from 2004 to 2017 by a single surgeon in Shiraz, Iran, were clinically and radiographically evaluated. The preoperative questionnaires of SF36, WOMAC, KSS, and radiographs were compared with the follow-up assessments of the same parameters. Data were analyzed by R programming language using student t test, ANOVA, and Kruskal-Wallis. P

Recent systematic reviews suggest that pharmacists' interventions in asthma patients have a positive impact on health‐related outcomes. Nevertheless, the association is not well established, and the role of clinical pharmacists is poorly represented. The aim of this overview of systematic reviews is to identify published systematic reviews assessing the impact of pharmacists' interventions on health‐related outcomes measured in asthma patients. PubMed, Embase, Scopus, and Cochrane Library were searched from inception to December 2022. Systematic reviews of all study designs and settings were included. Methodological quality was assessed using AMSTAR 2. Two investigators performed study selection, quality assessment and data collection independently. Nine systematic reviews met the inclusion criteria. Methodological quality was rated as high in one, low in two, and critically low in six. Reviews included 51 primary studies reporting mainly quality of life, asthma control, lung capacity, and therapeutic adherence. Only four studies were carried out in a hospital setting and only two reviews stated the inclusion of severe asthma patients. The quality of the systematic reviews was generally low, and this was the major limitation of this overview of systematic reviews. However, solid evidence supports that pharmaceutical care improves health‐related outcomes in asthma patients. [ABSTRACT FROM AUTHOR]

Introduction: Logistic regression models are frequently used to estimate measures of association between an exposure, health determinant or intervention, and a binary outcome. However, when the outcome is frequent (> 10%), model estimates for relative risks and prevalence ratios might be biased. Despite the availability of several alternatives, many still rely on these models, and a consensus is yet to be reached. We aimed to compare the estimation and goodness-of-fit of logistic, log-binomial and robust Poisson regression models, in cross-sectional studies involving frequent binary outcomes. Methods: Two cross-sectional studies were conducted. Study 1 was a nationally representative study on the impact of air pollution on mental health. Study 2 was a local study on immigrants’ access to urgent healthcare services. Odds ratios (OR) were obtained through logistic regression, and prevalence ratios (PR) through log-binomial and robust Poisson regression models. Confidence intervals (CI), their ranges, and standard-errors (SE) were also computed, along with models’ relative goodness-of-fit through Akaike Information Criterion (AIC), when applicable. Results: In Study 1, the OR (95% CI) was 1.015 (0.970 - 1.063), while the PR (95% CI) obtained through the robust Poisson mode was 1.012 (0.979 - 1.045). The log-binomial regression model did not converge in this study. In Study 2, the OR (95% CI) was 1.584 (1.026 - 2.446), the PR (95% CI) for the log-binomial model was 1.217 (0.978 - 1.515), and 1.130 (1.013 - 1.261) for the robust Poisson model. The 95% CI, their ranges, and the SE of the OR were higher than those of the PR, in both studies. However, in Study 2, the AIC value was lower for the logistic regression model. Conclusion: The odds ratio overestimated PR with wider 95% CI and higher SE. The overestimation was greater as the outcome of the study became more prevalent, in line with previous studies. In Study 2, the logistic regression was the model with the best fit, illustrating the need to consider multiple criteria when selecting the most appropriate statistical model for each study. Employing logistic regression models by default might lead to misinterpretations. Robust Poisson models are viable alternatives in cross-sectional studies with frequent binary outcomes, avoiding the non-convergence of log-binomial models.

Purpose The long-term cosmetic outcomes of simple facial lacerations have not been well addressed, specifically regarding those of suturing by pediatric emergency physicians (PEPs) and plastic surgery (PS) residents. Methods A retrospective study was performed at the pediatric emergency department of Shaare Zedek Medical Center in Jerusalem, Israel. Cosmetic outcomes of simple facial lacerations sutured within 1 year of the study were reviewed using digital photographs taken by legal guardians of children sutured in the department. The photographs were reviewed and rated blindly using the Stony Brook scar score as measures of cosmetic outcomes by 2 plastic surgeons and 1 PEP, as well as the general numeric score (GNS) rated by the guardians and the 3 doctors. The scores were compared between children sutured by PEPs (PEP group) and those sutured by PS residents (PS group). A sample size of 50 children in each study group was calculated to have enough power to show a difference. Results Among a total of 108 children who participated in the study (median age, 4.0 years [interquartile range, 3.0-7.0]), 57 and 51 were sutured by PEPs and PS residents, respectively. Guardian-rated median GNS showed no difference between the 2 groups (PEP, 90.0 [70.0-95.0] vs. PS, 90.0 [60.0-90.0]; P = 0.310). In contrast, doctor-rated median GNS was higher in the PEP group (PEP, 75.0 [63.3-86.7] vs. PS, 70.0 [53.3-83.3]; P = 0.046). A Stony Brook scar score of 3 or higher was similarly frequent in both groups (PEP, 87.7% vs. PS, 74.5%; P = 0.173) with a low interrater agreement (Kappa = 0.36). Conclusion Cosmetic outcomes of simple facial lacerations in the pediatric emergency department were favorable regardless of the specialty or expertise of doctors. The guardians were more satisfied with the outcomes, compared to the doctors.

Background Sinus venosus atrial septal defect (SVASD) is a rare congenital cardiac anomaly comprising 5% to 10% of all atrial septal defects. Although surgical closure is the standard treatment for SVASD, data on outcomes have been confined to small cohorts. Thus, we conducted a systematic review of the outcomes of SVASD repair. Methods and Results The primary outcome was death. Secondary outcomes encompassed atrial fibrillation, sinus node dysfunction, pacemaker insertion, cerebrovascular accident, reoperation, residual septal defect, superior vena cava obstruction, and reimplanted pulmonary vein obstruction. Pooled incidences of outcomes were calculated using a random‐effects model. Forty studies involving 1320 patients who underwent SVASD repair were included. The majority were male patients (55.4%), with 88.0% presenting with associated anomalous pulmonary venous connection. The weighted mean age was 18.6±12.5 years, and the overall weighted mean follow‐up period was 8.6±10.4 years. The in‐hospital mortality rate was 0.24%, with a 30‐day mortality rate of 0.5% reported in 780 patients. Incidences of atrial fibrillation, sinus node dysfunction, pacemaker insertion, and cerebrovascular accident over the long‐term follow‐up were 3.3% (2.18%–4.93%), 6.5% (5.09%–8.2%), 2.23% (1.34%–3.57%), and 2.03% (0.89%–2.46%) respectively. Reoperation occurred in 1.36% (0.68%–2.42%) of surgeries, residual septal defect in 1.34% (0.69%–2.42%), superior vena cava obstruction in 1.76% (1.02%–2.9%), and reimplanted pulmonary vein obstruction in 1.4% (0.7%–2.49%). Conclusions This is the first comprehensive analysis of outcomes following surgical repair of SVASD. The findings affirm the safety and effectiveness of surgery, establishing a reference point for evaluating emerging transcatheter therapies. Safety and efficacy profiles comparable to surgical repair are essential for widespread adoption of transcatheter treatments.

Background Understanding the causes of intracerebral hemorrhage (ICH) is crucial for effective treatment and preventing recurrences. The SMASH-U scale is a suggested method for classifying and predicting the outcomes of ICH.

Background Coordinated regional health development aims to optimize resource allocation by constructing a well-structured and functional regional collaborative system to provide continuous medical services, and to leverage the unique features and strengths of medical centers and community health centers within a region via fully integrating resources and sharing information. However, current available systems for assessing coordinated regional health development mainly focus on outcomes, which are relatively non-diversified and unsystematic, thus further research is required to fill this gap. Objective We aimed to construct an evaluation system for coordinated regional health development, to provide scientific evidence for evaluating the coordinated development capacities of regions. Methods We collected essential factors related to coordinated regional health development through a literature review and semi-structured interviews, and used them to construct a draft version of the Coordinated Regional Health Development Assessment System (CRHDAS) . Then we selected 19 experts who were familiar with coordinated regional health development (engaging in general medicine, medical education, administrative management, and public health management) from Shanghai to attend two rounds of online combined with offline Delphi questionnaire surveys from December 2020 to March 2021 to determine the weights of the indicators and test the logical consistency of the weights of indicators at each level using Analytic Hierarchy Process. After that, we established the final version of CRHDAS. Results The effective response rate and authoritative coefficient were 95.0% and 0.87, respectively, for the first round of survey, and were 100.0% and 0.92, respectively, for the second round of survey. The CRHDAS consists of four first-level indicators (with corresponding weights of 0.387, 0.296, 0.187 and 0.130) , 12 second-level indicators, and 31 third-level indicators. The consistency ratios for the weights of three levels of indicators are

ABSTRACT OBJECTIVE Evaluate and compare the protagonism of Oral Health teams (OHt) in the teamwork process in Primary Healthcare (PHC) over five years and estimate the magnitude of disparities between Brazilian macro-regions. METHODS Ecological study that used secondary data extracted from the Sistema de Informação em Saúde para a Atenção Básica (SISAB – Health Information System for Primary Healthcare) from 2018 to 2022. Indicators were selected from a previously validated evaluative matrix, calculated from records in the Collective Activity Form on the degree of OHt’s protagonism in team meetings and its degree of organization concerning the meeting agendas. A descriptive and amplitude analysis of the indicators’ variation over time was carried out, and the disparity index was also calculated to estimate and compare the magnitude of differences between macro-regions in 2022. RESULTS In Brazil, between 3.06% and 4.04% of team meetings were led by OHt professionals. The Northeast and South regions had the highest (3.71% to 4.88%) and lowest proportions (1.21% to 2.48%), respectively. From 2018 to 2022, there was a reduction in the indicator of the “degree of protagonism of the OHt” in Brazil and macro-regions. The most frequent topics in meetings under OHt’s responsibility were the work process (54.71% to 70.64%) and diagnosis and monitoring of the territory (33.49% to 54.48%). The most significant disparities between regions were observed for the indicator “degree of organization of the OHt concerning case discussion and singular therapeutic projects”. CONCLUSIONS The protagonism of the OHt in the teamwork process in PHC is incipient and presents regional disparities, which challenges managers and OHt to break isolation and lack of integration, aiming to offer comprehensive and quality healthcare to the user of the Unified Health System (SUS).

Aim: This study addresses the absence of a definition of care for children with feeding disorders, limited agreement on key performance indicators (KPIs), and the lack of data linked to those KPIs. Methods: Clinicians, consumers and researchers involved in outpatient feeding care in New South Wales (NSW), Australia were invited to participate in a two‐Phase study. In Phase 1, a modified Delphi method was used. Two rounds of voting resulted in a new consensus definition of a multidisciplinary paediatric feeding clinic. Three further rounds voting determined relevant KPIs. In Phase 2, the KPIs were piloted prospectively in 10 clinics. Results: Twenty‐six clinicians, consumers and researchers participated in Phase 1. Participation across five voting rounds declined from 92% to 60% and a valid definition and KPI set were created. In Phase 2, the definition and KPIs were piloted in 10 clinics over 6 weeks. Data for 110 patients were collected. The final KPI set of 28 measures proposed covers clinical features, patient demographics and medical issues, parent–child interaction and outcome measures. Conclusions: A new definition of a multidisciplinary paediatric feeding clinic is now available, linked to a standardised KPI set covering relevant performance measures. These proved viable in baseline data collection for 10 clinics across NSW. This sets a foundation for further data collection, systematic measurement of care provision and outcomes, and research needed to deliver care improvement for children with paediatric feeding disorder. [ABSTRACT FROM AUTHOR]

Objective: To assess the internal construct validity, including local independence, unidimensionality, monotonicity, and invariance, reliability, and targeting of the Forgotten Joint Score within the Rasch Measurement Theory framework. Design: Cross-sectional study. Patients: A total of 111 patients with total hip arthroplasty at least 3 months after surgery. Methods: The Forgotten Joint Score was submitted to each subject during their rehabilitative treatment in an Italian centre and then to Rasch analysis. Results: The base Rasch analysis showed a satisfactory fit to the model with strict unidimensionality and no differential item functioning. However, monotonicity (11 out of 12 items showed disordered thresholds) and local independence were violated. After rescoring 10 items and creating 5 subtests to account for local dependence, the scale satisfied all the other Rasch model requirements (i.e. invariance, local independence, monotonicity, unidimensionality, and multi-group invariance), with reliability indexes (> 0.850) for measurement at the individual level and proper targeting. A raw-score-to-measure conversion table was provided. Conclusion: After structural (i.e. collapsing items categories) and non-structural (i.e. creating subtests) strategies, the Forgotten Joint Score satisfied the measurement requirements of the Rasch model, and it can be used in patients with total hip arthroplasty in clinical and research settings.

Background/importance: Delayed cerebral ischemia (DCI) is the second-leading cause of death and disability in patients with aneurysmal subarachnoid hemorrhage (aSAH), and is associated with cerebral arterial vasospasm (CAV). Current treatments for CAV are expensive, invasive, and have limited efficacy. Cervical sympathetic block (CSB) is an underappreciated, but potentially highly effective therapy for CAV.Objective: To provide a comprehensive review of the preclinical and human literature pertinent to CSB in the context of CAV.Evidence Review: This study followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. We conducted a literature search using Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Scopus and Web of Science until February 2022, to identify abstracts, conference proceedings, and full-text papers pertinent to cervical sympathectomy and CAV in animal/adult patients.Findings: We included six human and six experimental studies. Human studies were mostly prospective observational, except one retrospective and one randomized clinical trial, and used various imaging modalities to measure changes in arterial diameter after the block. Studies that used digital subtraction angiography showed an improvement in cerebral perfusion without change in vessel diameter. Transcranial Doppler studies found an approximately 15% statistically significant decrease in velocities consistent with arterial vasodilatation. Overall, the results suggest an increase in cerebral arterial diameter and neurological improvement in patients receiving a CSB. Animal studies demonstrate that sympathetic system ablation vasodilates cerebral vasculature and decreases the incidence of symptomatic vasospasm.Conclusions: This scoping review suggests that CSB may be a viable option for treatment and prevention of CAV/DCI in patients with aSAH, although the included studies were heterogeneous, mostly observational, and with a small sample size. Further research is needed to standardize the technique and prove its effectiveness to treat patients suffering of CAV/DCI after aSAH. [ABSTRACT FROM AUTHOR]

Candidate gene studies have identified genetic variants associated with clinical outcomes following aneurysmal subarachnoid haemorrhage (aSAH), but no genome-wide association studies have been performed to date. Here we report the results of the discovery phase of a two-stage genome-wide meta-analysis of outcome after aSAH. We identified 157 independent loci harbouring 756 genetic variants associated with outcome after aSAH (p < 1 × 10−4), which require validation. A single variant (rs12949158), in SPNS2, achieved genome-wide significance (p = 4.29 × 10−8) implicating sphingosine-1-phosphate signalling in outcome after aSAH. A large multicentre international effort to recruit samples for validation is required and ongoing. Validation of these findings will provide significant insight into the pathophysiology of outcomes after aSAH with potential implications for treatment. [ABSTRACT FROM AUTHOR]

Perioperative transfusion thresholds have garnered increasing scrutiny as restrictive strategies have been shown to be noninferior. The study authors used data from a statewide academic collaborative to test the association between transfusion and 30-day mortality. All adult patients undergoing coronary artery bypass grafting (CABG) and/or valve surgeries between 2013 and 2019 in the authors' Academic Cardiac Surgery Consortium were examined. The relationship between the number of overall packed red blood cell (pRBC) and coagulation product (CP) (fresh frozen plasma, cryoprecipitate, platelets) transfusions on 30-day mortality was evaluated. Multivariate regression was used to evaluate predictors of transfusion and study endpoints. Machine learning (ML) models also were developed to predict 30-day mortality and rank transfusion-related features by relative importance. At an Academic Cardiac Surgery Consortium of 5 institutions. Patients ≥18 years old undergoing CABG and/or valve surgeries. Of the 7,762 patients (median hematocrit [HCT] 39%, IQR 35%-43%) who were included in the final study cohort, >40% were transfused at least 1 unit of pRBC or CP. In adjusted analyses, higher preoperative HCT was associated with reduced odds of mortality (adjusted odds ratio [aOR] 0.95, 95% CI 0.92-0.98), renal failure (aOR 0.95, 95% CI 0.92-0.98), and prolonged mechanical ventilation (aOR 0.97, 95% CI 0.95-0.99). In contrast, perioperative transfusions were associated with increased 30-day mortality after adjustment for preoperative HCT and other baseline features. The ML models were able to predict 30-day mortality with an area under the curve of 0.814-to-0.850, with perioperative transfusions displaying the highest feature importance. The present analysis found increasing HCT to be associated with a lower incidence of mortality. The study authors also found a direct dose-response association between transfusions and all study endpoints examined. [ABSTRACT FROM AUTHOR]

Abstract Background Older adults are more prone to increasing comorbidities and polypharmacy. Polypharmacy is associated with inappropriate prescribing and an increased risk of adverse effects. This study examined the effect of polypharmacy in older adults on healthcare services utilization (HSU). It also explored the impact of different drug classes of polypharmacy including psychotropic, antihypertensive, and antidiabetic polypharmacy on HSU. Methods This is a retrospective cohort study. Community-dwelling older adults aged ≥ 65 years were selected from the primary care patient cohort database of the ambulatory clinics of the Department of Family Medicine at the American University of Beirut Medical Center. Concomitant use of 5 or more prescription medications was considered polypharmacy. Demographics, Charlson Comorbidity index (CCI), and HSU outcomes, including the rate of all-cause emergency department (ED) visits, rate of all-cause hospitalization, rate of ED visits for pneumonia, rate of hospitalization for pneumonia, and mortality were collected. Binomial logistic regression models were used to predict the rates of HSU outcomes. Results A total of 496 patients were analyzed. Comorbidities were present in all patients, with 22.8% (113) of patients having mild to moderate comorbidity and 77.2% (383) of patients having severe comorbidity. Patients with polypharmacy were more likely to have severe comorbidity compared to patients with no polypharmacy (72.3% vs. 27.7%, p = 0.001). Patients with polypharmacy were more likely to visit the ED for all causes as compared to patients without polypharmacy (40.6% vs. 31.4%, p = 0.05), and had a significantly higher rate of all-cause hospitalization (adjusted odds ratio aOR 1.66, 95 CI = 1.08–2.56, p = 0.022). Patients with psychotropic polypharmacy were more likely to be hospitalized due to pneumonia (crude odds ratio cOR 2.37, 95 CI = 1.03–5.46, p = 0.043), and to visit ED for Pneumonia (cOR 2.31, 95 CI = 1.00–5.31, p = 0.049). The association lost significance after adjustment. Conclusions The increasing prevalence of polypharmacy amongst the geriatric population with comorbidity is associated with an increase in HSU outcomes. As such, frequent medication revisions in a holistic, multi-disciplinary approach are needed.

Background/Aims Colonic volvulus (CV), a common cause of bowel obstruction, often requires intervention. We aimed to identify hospitalization trends and CV outcomes in the United States. Methods We used the National Inpatient Sample to identify all adult CV hospitalizations in the United States from 2007 to 2017. Patient demographics, comorbidities, and inpatient outcomes were highlighted. Outcomes of endoscopic and surgical management were compared. Results From 2007 to 2017, there were 220,666 CV hospitalizations. CV-related hospitalizations increased from 17,888 in 2007 to 21,715 in 2017 (p=0.001). However, inpatient mortality decreased from 7.6% in 2007 to 6.2% in 2017 (p

Diagnostic errors in medicine represent a significant public health problem but continue to be challenging to measure accurately, reliably, and efficiently. The recently developed Symptom-Disease Pair Analysis of Diagnostic Error (SPADE) approach measures misdiagnosis related harms using electronic health records or administrative claims data. The approach is clinically valid, methodologically sound, statistically robust, and operationally viable without the requirement for manual chart review. This paper clarifies aspects of the SPADE analysis to assure that researchers apply this method to yield valid results with a particular emphasis on defining appropriate comparator groups and analytical strategies for balancing differences between these groups. We discuss four distinct types of comparators (intra-group and inter-group for both look-back and look-forward analyses), detailing the rationale for choosing one over the other and inferences that can be drawn from these comparative analyses. Our aim is that these additional analytical practices will improve the validity of SPADE and related approaches to quantify diagnostic error in medicine. [ABSTRACT FROM AUTHOR]

• Sufficient evidence to use the MPAI-4 and its participation index (M2PI) in stroke outpatients. • Sufficient evidence to use the MPAI-4 and M2PI in TBI inpatients and outpatients. • More evidence is needed for adapted versions of the MPAI-4. • Future research is needed for the MPAI-4 and M2PI's content validity, reliability, predictive validity, and measurement error. • This review provides a model for adapting COSMIN to incorporate Rasch results. To assess the Mayo-Portland Adaptability Inventory—version 4 (MPAI-4) and related measures' measurement properties and the quality of evidence supporting these results; and identify the interpretability and feasibility of the MPAI-4 and related measures. We conducted a systematic review according to COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines. We searched 9 electronic databases and registries, and hand searched reference lists of included articles. Two independent reviewers screened and selected all articles. From 605 retrieved articles, 48 were included. Two independent reviewers appraised the evidence quality and rated the extracted classical test theory and Rasch results from each study. We used meta-analysis and COSMIN's approach to synthesize measurement properties evidence (insufficient, sufficient), and the modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to synthesize evidence quality (very low, low, moderate, high) by diagnosis (traumatic brain injury [TBI], stroke), and setting (inpatient, outpatient). The MPAI-4 and its subscales are sufficiently comprehensible (GRADE: very low), but there is currently no other content validity evidence (relevance, comprehensiveness). The MPAI-4 and its participation index (M2PI) have sufficient interrater reliability for stroke and TBI outpatients (GRADE: moderate), whereas interrater reliability between TBI inpatients and clinicians is currently insufficient (GRADE: moderate). There is no evidence for measurement error. For stroke and TBI outpatients, the MPAI-4 and M2PI have sufficient construct validity (GRADE: high) and responsiveness (GRADE: moderate-high). For TBI inpatients, the MPAI-4 and M2PI have mixed indeterminant/sufficient construct validity and responsiveness evidence (GRADE: moderate-high). There is 1 study with mixed insufficient/sufficient evidence for each MPAI-4 adaptation (21- and 22-item MPAI, 9-item M2PI) (GRADE: low-high). Users can be most confident in using the MPAI-4 and M2PI in TBI and stroke outpatient settings. Future research is needed on reliability, measurement error, predictive validity, and content validity of the MPAI-4 and its related measures across populations and settings. [ABSTRACT FROM AUTHOR]

Purpose: Testosterone administration prior to hypospadias repair is common practice among pediatric urologists; however, its impact on surgical outcomes remains controversial. We hypothesize that testosterone administration prior to distal hypospadias repair with urethroplasty significantly decreases postoperative complications. Materials and Methods: We queried our hypospadias database for primary distal hypospadias repairs with urethroplasty from 2015 to 2021. Patients undergoing repair without urethroplasty were excluded. We collected information on patient age, procedure type, testosterone administration status, initial visit and intraoperative glans width, urethroplasty length, and postoperative complications. To determine the role of testosterone administration on incidence of complications, a logistic regression adjusting for initial visit glans width, urethroplasty length, and age was performed. Results: A total of 368 patients underwent distal hypospadias repair with urethroplasty. One hundred thirty-three patients received testosterone and 235 did not. Initial visit glans width was significantly larger in the no-testosterone vs testosterone group (14.5 mm vs 13.1 mm, P = .001). Testosterone patients had significantly larger glans width at the time of surgery (17.1 mm vs 14.6 mm =notestosterone group], P = .001). On multivariable logistic regression analysis after controlling for age at surgery, preoperative glans width, testosterone status, and urethroplasty length, testosterone administration did show significant association with reduced odds of postoperative complications (OR 0.4, P = .039). Conclusions: This retrospective review of patients shows that on multivariable analysis there is significant association between testosterone administration and decreased incidence of complications in patients undergoing distal hypospadias repair with urethroplasty. Future studies on testosterone administration should focus on specific cohorts of patients with hypospadias as benefits of testosterone may be more evident in some subgroups than others. [ABSTRACT FROM AUTHOR]

ABSTRACT Objectives: Describe the frequency and types of outcomes in randomized clinical trials (RCT) of intervention for distal radius fractures, analyze how confusing outcome presentations can lead to misinterpretations, and suggest strategies to improve the reader's understanding of the decision-making process. Methods: A retrospective study was conducted through a systematized search on the PubMed® database in the last 10 years, in which only intervention RCT was included for distal radius fractures, and outcomes were analyzed. Results: Of the primary outcomes analyzed in the 75 selected articles, 46.6% were classified as clinical outcomes, 20% as surrogate, 30.6% as composite, 1.3% as complex scales, and 1.3% as safety outcomes. 34.7% of the articles did not report adverse events. Conclusion: The presentation of outcomes with little clinical relevance represented more than half of the sample (53.4%) - such studies can harm the reader since they confuse the interpretation of scientific evidence; the Core Outcome Measures in Effectiveness Trials (COMET) initiative could help health professionals in understanding and selecting the most appropriate therapeutic interventions for patients. Level of Evidence III; Retrospective comparative study .

Introduction: Head and neck neoplasms often affect fundamental functions, such as swallowing, speech, eating, and socializing. Evaluating their treatment should consider the physician’s opinion and the patient’s perspective. This difficulty in assessing the success of treatment led to the development of the FACE-Q Head and Neck Cancer Module, a questionnaire of patient-reported outcomes that measure the appearance, facial function, quality of life, and experience of care to head and neck neoplasms. The objective is to translation, cultural adaptation, and linguistic validation of the FACE-Q Head and Neck Cancer questionnaire for Brazilian Portuguese. Methods: The translation, cultural adaptation, and linguistic validation of the full questionnaire took place in four stages, using official guidelines from the World Health Organization and the International Society of Pharmacoeconomics and Outcomes Research. Results: A semantic, idiomatic, and conceptually equivalent Brazilian Portuguese version was achieved through a linguistically validated translation of the English FACE-Q Head and Neck Cancer module. Conclusion: The Brazilian Portuguese version presents a version equivalent to the original English instrument, which can be used as a critical patient-reported outcome assessment.

Background Headaches are a leading cause of years lived with disability. For some people, headaches become chronic and disabling, with treatment options being primarily pharmaceutical. Non-pharmacological alternative treatment approaches are worthy of exploration. Aim To develop and test an educational and supportive self-management intervention for people with chronic headaches. Objectives To develop and evaluate a brief diagnostic interview to support diagnosis for people with chronic headaches, and then to develop and pilot an education and self-management support intervention for the management of common chronic headache disorders (the CHESS intervention). To select the most appropriate outcome measures for a randomised controlled trial of the CHESS intervention, and then to conduct a randomised controlled trial and economic evaluation of the CHESS intervention with an embedded process evaluation. Design Developmental and feasibility studies followed by a randomised controlled trial. Setting General practice and community settings in the Midlands and London, UK. Participants For our feasibility work, 14 general practices recruited 131 people with chronic headaches (headaches on ≥15 days per month for >3 months). People with chronic headaches and expert clinicians developed a telephone classification interview for chronic headache that we validated with 107 feasibility study participants. We piloted the CHESS intervention with 13 participants and refined the content and structure based on their feedback. People with chronic headaches contributed to the decisions about our primary outcome and a core outcome set for chronic and episodic migraine. For the randomised controlled trial, we recruited adults with chronic migraine or chronic tension-type headache and episodic migraine, with or without medication overuse headache, from general practices and via self-referral. Our main analyses were on people with migraine. Interventions The CHESS intervention consisted of two 1-day group sessions focused on education and self-management to promote behaviour change and support learning strategies to manage chronic headaches. This was followed by a one-to-one nurse consultation and telephone support. The control intervention consisted of feedback from classification interviews, headache management leaflet and a relaxation compact disc. Main outcome measures The primary outcome was headache-related quality of life measured using the Headache Impact Test-6 at 12 months. The secondary outcomes included the Chronic Headache Quality of Life Questionnaire; headache days, duration and severity; EuroQol-5 Dimensions, five-level version; Short Form Questionnaire-12 items; Hospital Anxiety and Depression Scale; and Pain Self-Efficacy Questionnaire scores. We followed up participants at 4, 8 and 12 months. Results Between April 2017 and March 2019, we randomised 736 participants from 164 general practices. Nine participants (1%) had chronic tension-type headache only. Our main analyses were on the remaining 727 participants with migraine (376 in the intervention arm and 351 in the usual-care arm). Baseline characteristics were well matched. For the primary outcome we had analysable data from 579 participants (80%) at 12 months. There was no between-group difference in the Headache Impact Test-6 at 12 months, (adjusted mean difference –0.3, 95% confidence interval –1.23 to 0.67; p = 0.56). The limits of the 95% confidence interval effectively exclude the possibility of the intervention having a worthwhile benefit. At 4 months there was a difference favouring the CHESS self-management programme on the Headache Impact Test-6 (adjusted mean difference –1.0, 95% confidence interval –1.91 to –0.006; p = 0.049). However, the self-management group also reported 1.5 (95% confidence interval 0.48 to 2.56) more headache days in the previous 28 days. Apart from improved pain self-efficacy at 4 and 12 months, there were few other statistically significant between-group differences in the secondary outcomes. The CHESS intervention generated 0.031 (95% confidence interval –0.005 to 0.063) additional quality-adjusted life-years and increased NHS and Personal Social Services costs by £268 (95% confidence interval £176 to £377), on average, generating an incremental cost-effectiveness ratio of £8617 with an 83% chance of being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year. The CHESS intervention was well received and fidelity was good. No process-related issues were identified that would explain why the intervention was ineffective. Limitations Only 288 out of 376 (77%) of those randomised to the CHESS intervention attended one or more of the intervention sessions. Conclusions This short, non-pharmacological, educational self-management intervention is unlikely to be effective for the treatment of people with chronic headaches and migraine. Future work There is a need to develop and test more sustained non-pharmacological interventions for people with chronic headache disorders. Patient and public involvement Substantial patient and public involvement went into the design, conduct and interpretation of the CHESS programme. This helped direct the research and ensured that the patient voice was embedded in our work. Trial registration This trial is registered as ISRCTN79708100. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 2. See the NIHR Journals Library website for further information. Plain language summary What did we want to find out? We wanted to find out if an education and self-management support programme for people with frequent headaches made these people feel better. What did we do? We first made sure that we could find people with frequent headaches, from general practice, who would want to take part in our study. We then trained nurses to do telephone interviews to find out what sort of headaches people had. We looked at previous research and then, together with people with frequent headaches, designed a group education and self-management programme. It was run by a nurse and another health professional over 2 days, followed by a one-to-one session and telephone support with a nurse. We worked with people with frequent headaches and health professionals specialising in headaches to agree how best to measure how headaches affect people’s quality of life. We then tested our self-management programme. We recruited 736 people with frequent headaches, of whom 727 had migraine. Using a computer, we allocated them at random either to attend the self-management programme or to receive a relaxation compact disc. Everyone was told their headache type. We asked participants to tell us about their headaches and headache quality of life after 4 months, 8 months and 12 months. What did we find? Our main results are for the 727 people with migraine. Our support programme did not help people in our study with frequent migraines to live better. There were also no important differences in the number of headaches people had each month or the amount of prescribed or over-the-counter medication they took for their headaches. What does this mean? Our short 2-day programme did not appear to improve headache-related quality of life or reduce the number of headache days. Other ways of helping people manage their chronic headaches are needed. Scientific summary Background Headaches are second to low back pain as a global cause of years lived with disability. Headaches are the most common neurological disorder treated in primary care. They account for around 3% of general practitioner consultations. Seventy per cent of people with headaches seen by their general practitioner do not get a formal diagnosis. For some people headaches become a chronic disabling disorder. There is a need for more non-pharmacological treatments to help those living with headache disorders. Our overarching aim was to develop and test a supportive education and self-management group intervention, implementable in primary care, for people with chronic headaches. Objectives The objectives of the programme were to: •develop and test strategies for recruiting people with chronic headaches from primary care [work package (WP) 1] •develop and evaluate a brief classification interview to support diagnosis for people with chronic headaches (WP2) •develop and pilot an education and self-management support intervention for the management of common chronic headache disorders [the Chronic Headache Education and Self-management Study (CHESS) intervention] (WP3) •select the most appropriate outcome measures for a randomised controlled trial of the CHESS intervention package (WP4) •run a multicentre randomised controlled trial, including an economic evaluation, of the CHESS intervention package (WP5). Methods and results We used an epidemiological definition of chronic headaches: headaches on ≥15 days per month for >3 months. Phase 1 of our work, WPs 1–4, consisted of interlinked systematic reviews and a feasibility study. Feasibility study (work package 1) Fourteen general practices in the West Midlands recruited 131 people with chronic headaches by writing to people with recorded consultations for headaches and prescriptions for migraine-specific drugs (triptans and pizotifen). Eligibility was confirmed by a telephone call by the study team. This group was our sampling frame for WPs 2–4. Classification interview (work package 2) We wanted to identify the population of interest for the main trial but also to feel confident that those who had other headache types not suitable for our trial were appropriately identified and referred for relevant support. We first reviewed the literature on diagnostic tools and found 38 papers validating 30 tools. We did not find any tools that were suitable for our proposed trial. We therefore organised a consensus meeting to inform our thinking on the content of a new classification tool. This was attended by neurologists with a specialist interest in headaches, general neurologists, headache specialist nurses, general practitioners with a specialist interest in headaches and people with chronic headaches. We established what we needed to know from a person to: •exclude secondary headaches •exclude primary headaches other than chronic migraine and tension-type headache •distinguish between chronic tension-type headache and chronic migraine •identify medication overuse headache. We used this information to develop a classification logic model for use in a nurse-delivered classification interview. A research nurse and a doctor, with expertise in headaches, from the National Migraine Centre then independently interviewed 107 participants. We found a high level of agreement between the nurse and specialist. Over 90% of study participants were classified as having chronic migraine. Intervention development (work package 3) Three systematic reviews informed our intervention development. Using a meta-ethnographic approach our systematic review of the lived experience of chronic headaches (n = 4 studies) we found three overarching themes: •headache as a driver of behaviour •the spectre of headache •strained relationships. In our systematic review of prognostic factors in chronic headache (n = 27 studies), we found moderate evidence for depression and anxiety, poor sleep, stress, medication overuse and poor self-efficacy predicting a poor outcome. We found inconclusive evidence for treatment expectations, age and age at onset, body mass index, employment and headache features predicting a poor outcome. In our systematic review of the effectiveness, style and content of self-management interventions for chronic headache (n = 16 studies) we found beneficial effects of the interventions compared with usual care in pain intensity, headache-related disability and quality of life. Interventions including either education or mindfulness components, and delivered in a group format, showed greater reductions in pain intensity than interventions without these features. A greater beneficial effect on mood was observed in interventions that included a cognitive–behavioural approach component than in those without this. We interviewed seven people living with chronic headaches recruited through our charity partners. We found that participants had tried a range of therapies and interventions, some of which were helpful and others less so. Access to education and peer support was deemed positive, as was learning new skills such as relaxation, mindfulness and stress management. We then presented our findings to 18 people from clinical, academic and lay backgrounds at an intervention development day to agree the structure and content of our new intervention. We agreed on a modular group intervention for 8–10 people delivered by a nurse and a layperson with chronic headaches. It should include educational material, self-management material and medication advice, and include a digital versatile disc (DVD) suitable to share with friends and family. We included a single face-to-face session and up to 8 weeks of telephone support with a specially trained nurse. After piloting with 13 participants, we identified that it was difficult for lay facilitators to commit to the sessions because of the unpredictable nature of their headaches. We therefore changed to using allied health professionals as the second facilitator. The final format was two group days followed by a one-to-one session with a nurse to discuss medication, lifestyle factors and goal-setting, followed by up to 8 weeks of telephone support (individually negotiated). Clinical effectiveness and cost-effectiveness measures (work package 4) In our systematic review of patient-reported outcomes (46 studies evaluating 23 patient measures) we found that for a ‘headache’ population only the Headache Impact Test-6 (HIT-6) had acceptable evidence for its validity and reliability for use in our trial. The Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) had relevance to our population. We modified this measure, changing the focus of each item from ‘migraine’ to ‘headache’ to produce the Chronic Headache Quality of Life Questionnaire (CHQLQ) and did a mixed-methods comparative evaluation of the CHQLQ and HIT-6. Both the CHQLQ and the HIT-6 were well completed, had good psychometric properties and were relevant to the experience of headache. The CHQLQ captured the wide-ranging impact of chronic headache, in particular the emotional impact, to a greater extent than the HIT-6. As this work was not complete before starting the main trial, we set HIT-6 as the primary outcome for the trial and the CHQLQ as a secondary outcome. We developed three questions to capture headache frequency, duration and severity for use in a smartphone application (app) or in a paper diary. Eight feasibility participants tested the app over 11 weeks. Feedback was positive but completion rates varied. We included the app as part of the main trial. From our work on outcome measures we identified the need for a core outcome set for migraine. This work took place after the design of the randomised controlled trial had been finalised. We identified >50 domains from our systematic reviews and our qualitative work. We did a modified, three-round electronic Delphi study with patients and professionals to identify which domains were most important. At a consensus day, when the aim was to ratify the core domains, a two-domain core outcome set was agreed for chronic and episodic migraine: 1.migraine-specific pain – to be assessed with an 11-point numerical pain rating scale, and frequency as the number of headache/migraine days over a specified period 2.migraine-specific quality of life to be assessed with the Migraine Functional Impact Questionnaire (MFIQ). Professor Underwood, the chief investigator for this study, is a director and shareholder of Clinvivo Ltd, who provided the Delphi platform. He recused himself from any discussions related to the choice of Delphi platform for this study. Phase 2: randomised controlled trial, work package 5 Phase 2 of the programme was a randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of the CHESS intervention package. We identified people with chronic headaches from general practice records. Self-referral to the trial was also possible. We included adults with migraine or tension-type headache with or without medication overuse headache. People who appeared eligible after an initial telephone call were asked to provide consent and baseline measures. This was followed by a classification interview with a research nurse to confirm eligibility and identify people with suspected non-eligible headaches. After the feasibility study we specified that if at least 85% of our participants had migraine our primary analysis would just be on the population with migraine, with sample size inflated, if necessary, to ensure adequate statistical power for this analysis. The randomisation allocation ratio was 1 : 1.07 in favour of the intervention group to account for clustering in one arm. Randomisation was done using minimisation, stratifying by geographical locality (Midlands and Greater London) and headache type [definite chronic migraine, probable chronic migraine (i.e. episodic migraine plus chronic tension-type headache) and chronic tension-type headache only, with or without medication overuse headache]. Our primary outcome was the HIT-6 score at 1 year. We used the Migraine-Specific Quality of Life Questionnaire as the secondary headache disability outcome. We did follow-ups at 4, 8 and 12 months. The sample size was based on testing the clinical effectiveness in the migraine population excluding participants with just tension-type headache (n = 689 participants: relaxation arm, n = 689; self-management arm, n = 356) provided 90% power to detect a between-group difference of 2 points (standard deviation 6.87 points, from the feasibility study) in HIT-6 score at 12 months for those with migraine using a two-sided test and a 5% significance level with a 20% loss to follow-up. Some over-run on sample size was expected to allow all groups to be adequately populated. We did a within-trial health economic analysis. Between April 2017 and March 2019, staff at 164 general practices in the Midlands and London wrote to 31,026 people and we randomised 736 people, 727 (99%) with migraine: 54% (396/727) had chronic migraine and 56% (407/727) medication overuse headache. Despite reporting chronic headache when eligibility for the study was determined, after receiving informed consent at baseline, 38% (274/727) reported < 15 headache days in the preceding 4 weeks. Unless otherwise stated, analyses were on the 727 participants with migraine. Baseline characteristics were well matched. The first session was attended by 286 out of 376 (76%) intervention participants; 259 (69%) reached the minimum adherence (day 1, and the one-to-one session) and 216 (58%) achieved full adherence to the programme. There was no between-group difference in HIT-6 scores at 12 months [adjusted mean difference –0.3 points, 95% confidence interval (CI) –1.23 to 0.67 points; p = 0.56]. The limits of this 95% CI excluded our target (worthwhile) effect size of 2.0 points and the smaller minimally clinically important difference of 1.5 points suggested by others for studies of episodic migraine. At 4 months there was a difference favouring the CHESS self-management programme (adjusted mean difference –1.0 points; 95% CI –1.91 to –0.006 points; p = 0.049). There were few differences in secondary outcomes. The self-management group had 1.5 (95% CI 0.48 to 2.56; p = 0.004) more headache days over the preceding 28 days at 4 months. They also had improved pain self-efficacy scores at 4 and 12 months. Use of acute drugs, including both prescribed and over-the-counter drugs, and prophylactic drugs was unchanged over time with no between-group differences. Using electronic/paper diary data the difference over 12 months in number of headache days was 0.2 days (95% CI –0.11 to 0.46 days; p = 0.234), difference in duration of each headache was 0.4 hours (95% CI –0.47 to 1.28 hours; p = 0.361) and difference in average headache severity on a 0–10 scale was 0.2 (95% CI –0.08 to 0.46; p = 0.163). We found no subgroup effects. Our complier-average causal effect and sensitivity analyses were not materially different. There were seven adverse events: two in the standard-care arm and five in the self-management arm. The CHESS intervention generated 0.031 (95% CI –0.005 to 0.063) additional quality-adjusted life-years (QALYs) and increased NHS and Personal Social Services costs by £268 (95% CI £176 to £377), generating an incremental cost-effectiveness ratio of £8617 with an 83% chance of being cost-effective at a willingness to pay of £20,000 per QALY gained. Our process evaluation, including all 736 participants, showed that we recruited a nationally representative population including people from practices based in all 10 deciles of the Index of Multiple Deprivation; 18% of participants were from minority ethnic groups. Intervention fidelity was good, with adherence being slightly better than competence [adherence 83% (interquartile range 67–100%); competence 70% (interquartile range 50–90%)]. We carried out semistructured interviews with a purposive sample of 26 study participants. Most participants described gaining some new knowledge or insight about their headaches from the intervention they received, and a few changed medication. Some felt more confident to manage their headaches, but many did not. CHESS was well received by participants, facilitators and general practitioners. Participants enjoyed interacting with others and valued the opportunity to talk, share and discuss their chronic headache experiences with others in a similar situation in a safe knowledgeable space. Patient and public involvement There has been substantial patient and public involvement in the design, conduct and interpretation of the CHESS programme. Throughout the programme we worked closely with three UK migraine charities and a lay advisory group to help direct the research and ensure that the patient voice was embedded in our work. Conclusions Over the duration of the CHESS programme, we have advanced our understanding of the challenges of living with chronic headaches and made some progress in developing the methodology for running randomised controlled trials of complex interventions for people living with chronic headaches. Our data effectively excluded the possibility that this short intervention is effective for the treatment of chronic migraine or chronic tension-type headache and episodic migraine. Although there was no effect on our chosen headache-specific outcomes, we have not excluded the possibility that it produces a worthwhile QALY gain, as measured by the EuroQol-5 Dimensions, five-level version. The health burden of chronic headache disorders, principally chronic migraine, is debilitating. Those living with the condition warrant support to optimise their care planning according to their needs and the latest knowledge about treatment and management. Further advances in this field must be driven by new theoretically and/or biologically informed intervention models. Research recommendations •New work to better understand the health impact of chronic headache disorders and to identify modifiable risk factors for a poor outcome. •Development and testing of new non-pharmacological interventions for a tightly phenotyped group with chronic migraine. •Research is needed to support improved classification of headache disorders in primary care to allow better targeting of the available drug treatments of proven effectiveness, and reduce medication overuse. Trial registration This trial is registered as ISRCTN79708100. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 2. See the NIHR Journals Library website for further project information.

Background: Older adults are more prone to increasing comorbidities and polypharmacy. Polypharmacy is associated with inappropriate prescribing and an increased risk of adverse effects. This study examined the effect of polypharmacy in older adults on healthcare services utilization (HSU). It also explored the impact of different drug classes of polypharmacy including psychotropic, antihypertensive, and antidiabetic polypharmacy on HSU. Methods: This is a retrospective cohort study. Community-dwelling older adults aged ≥ 65 years were selected from the primary care patient cohort database of the ambulatory clinics of the Department of Family Medicine at the American University of Beirut Medical Center. Concomitant use of 5 or more prescription medications was considered polypharmacy. Demographics, Charlson Comorbidity index (CCI), and HSU outcomes, including the rate of all-cause emergency department (ED) visits, rate of all-cause hospitalization, rate of ED visits for pneumonia, rate of hospitalization for pneumonia, and mortality were collected. Binomial logistic regression models were used to predict the rates of HSU outcomes. Results: A total of 496 patients were analyzed. Comorbidities were present in all patients, with 22.8% (113) of patients having mild to moderate comorbidity and 77.2% (383) of patients having severe comorbidity. Patients with polypharmacy were more likely to have severe comorbidity compared to patients with no polypharmacy (72.3% vs. 27.7%, p = 0.001). Patients with polypharmacy were more likely to visit the ED for all causes as compared to patients without polypharmacy (40.6% vs. 31.4%, p = 0.05), and had a significantly higher rate of all-cause hospitalization (adjusted odds ratio aOR 1.66, 95 CI = 1.08–2.56, p = 0.022). Patients with psychotropic polypharmacy were more likely to be hospitalized due to pneumonia (crude odds ratio cOR 2.37, 95 CI = 1.03–5.46, p = 0.043), and to visit ED for Pneumonia (cOR 2.31, 95 CI = 1.00–5.31, p = 0.049). The association lost significance after adjustment. Conclusions: The increasing prevalence of polypharmacy amongst the geriatric population with comorbidity is associated with an increase in HSU outcomes. As such, frequent medication revisions in a holistic, multi-disciplinary approach are needed. [ABSTRACT FROM AUTHOR]

Background: Optimization of perioperative pain interventions in lumbar spine surgery could reduce the incidence of acute and persistent postoperative pain and opioid consumption. Standardization in early outcome measurement provides a solid foundation for future clinical and research practices and should be integrated in core outcome sets for long-term treatment outcome evaluations. This scoping review provides an overview of outcomes used when evaluating early perioperative pain interventions after lumbar spine surgery.Objectives: To create an overview of outcome domains and measurement instruments previously used in research on perioperative pain management for degenerative lumbar spine surgery.Evidence Review: A scoping review was performed to identify articles comprising outcome evaluations in adult patients who undergo degenerative lumbar spine surgery, mentioning perioperative pain interventions. 75 articles were included for review. Data on study characteristics, outcome domains and measurement instruments were extracted and structured using the three-tiered hierarchy of Porter.Findings: 12 outcome domains were identified: pain intensity (93.3%), adverse events (76%), analgesic consumption (70.7%), length of stay (52%), patient satisfaction (24%), daily functioning (22.7%), (early) mobilization (22.7%), quality of life (12%), mortality (9.3%), quality of recovery (6.7%), physical function (4%), and quality of sleep (2.7%). 63 corresponding measurement instruments were found.Conclusions: This review portrays an extensive overview of outcome measurements used in perioperative pain management in lumbar spine surgery. A lack of consensus on the set of indicators exists. This scoping review is a call for action to create consensus on how to evaluate perioperative pain interventions in degenerative lumbar spine surgery. [ABSTRACT FROM AUTHOR]

• What is currently known about this topic? • Studies analyzing abnormal perioperative blood glucose and adverse surgical outcomes are limited to pediatric cardiac and pediatric neurosurgery. • What new information is contained in this article? • In pediatric patients undergoing non-cardiac surgery, perioperative dysglycemia is associated with increased risk of adverse events and surgical outcomes, including infection, morbidity, re-operation and prolonged hospital stay. Perioperative dysglycemia is associated with adverse surgical outcomes in adults. We sought to determine the association between perioperative dysglycemia and 30-day adverse surgical events in pediatric patients undergoing non-cardiac surgery. We analyzed records from the American College of Surgeons National Surgical Quality Improvement Program Pediatric (ACS-NSQIP-P) database from 2016 to 2021 at two academic tertiary care hospitals. The primary outcomes were individual 30-day adverse events, composite serious adverse events, composite hospital acquired infections and composite morbidity. A total of 5410 records were analyzed: the cohort was 52.6% male and 52.6% non-Hispanic White, and 1472 (27.2%) had dysglycemia. Children undergoing procedures in general surgery (48.4%), neurosurgery (25.4%), and orthopedic surgery (16.0%) had higher rates of dysglycemia compared to other surgical specialties. Patients with dysglycemia were more likely to have surgical site infection (4.3% dysglycemic vs. 3.1% normoglycemic, p = 0.028), cardiac arrest (2.6% vs. 0.1%, p < 0.001), and sepsis (3.7% vs. 1.3%, p < 0.001); more likely to undergo reoperation (11.3% vs. 5.8%, p < 0.001); and more likely to remain hospitalized after 30 days (33.0% vs. 6.1%, p < 0.001). After controlling for patient and case demographics, perioperative dysglycemia was associated with more composite serious adverse events (OR 1.85, 95% CI 1.49–2.29, p = 0.000), composite hospital acquired infections (OR 1.42, 95% CI 1.04–1.93, p = 0.026), and composite morbidity (OR 2.52, 95% CI 2.13–2.97, p = 0.000). Perioperative dysglycemia in children undergoing non-cardiac surgery is associated with increased risk of adverse events and outcomes. Interventions that screen and normalize blood glucose in the perioperative period may mitigate risk and improve quality of care. [ABSTRACT FROM AUTHOR]

Objective: To assess the frequency and predictors of unplanned readmissions after hospitalisation for incident atrial fibrillation (AF) and the association of readmissions with mortality over 2 years.Methods: We performed a retrospective cohort study using Western Australian morbidity and mortality data to identify all patients, aged 25-94 years, who survived incident (first-ever) hospitalisation for AF (principal diagnosis), between 2001 and 2015. Ordinal logistic models determined the covariates independently associated with unplanned readmission(s), and Cox proportional hazards models with time-varying exposures determined the hazard ratios (HR) of one or more readmissions for mortality over 2 years after incident AF.Results: Of 22 956 patients, 57.7% male, mean age 67.9 (SD 13.8) years, 44.0% experienced 22 053 unplanned readmissions within 2 years, 50.6% being cardiovascular-related. All-cause death occurred in 8.0% of the cohort, and the multivariable-adjusted mortality HR of 1 (vs 0) readmission was 2.9 (95% CI 2.6 to 3.3), increasing to 5.6 (95% CI 5.0 to 6.5) for 3+ readmissions. First emergent readmission for AF, stroke, heart failure or myocardial infarction was independently associated with an increased hazard for mortality. Coexistent cardiovascular and other comorbidities were independently associated with increased readmission and mortality risk, whereas AF ablation was associated with reduced risk.Conclusion: This study highlights the large burden of unplanned all-cause and cardiovascular-specific readmissions within 2 years after being hospitalised for incident AF and their associated adverse impact on mortality. Concomitant comorbidities are independently associated with unplanned hospitalisations and mortality, which supports integrated multidisciplinary management of comorbidities, along with AF-targeted treatments, to improve long-term outcomes in patients with AF. [ABSTRACT FROM AUTHOR]

Background: The last criterion for behavioral abnormality occurs outside social and cultural norms. The present study aimed to design a model of behavioral abnormalities of human resources of the Ministry of Health and Medical Education. Methods: The outcomes were identified through library studies, and the fuzzy Delphi technique was used with the opinion of experts until we reached a theoretical consensus. First, 13 factors were confirmed using the opinion of 50 experts. Then, a questionnaire was designed based on the results of the first stage of the study, and the experts were asked to specify the importance of each identified stage using verbal variables. Then, the verbal variables were converted into fuzzy triangular numbers, and the triangular fuzzy mean was de-fuzzified using the Minkowski formula by Excel and SPSS-21 software. Results: The members of the expert group reached a consensus on all components (dissatisfaction, drug abuse, alcohol consumption, reduction of motivation, moral corruption, malice and revenge, suicide, absenteeism, early and excessive leaves, theft and destruction of property, procrastination, arguments and physical violence, sexual harassment, violation of laws and character assassination and humiliation of colleagues). The de-fuzzified mean difference of experts' opinions in the two stages was less than 0.1, indicating the intensity of experts' agreement with each of the components of the conceptual model of the study. Conclusion: Behavioral abnormality is one of the problems of today's organizations, and the development of behavioral models in organizations is one way to guide employees' behavior and prevent the occurrence of abnormal behaviors.

ABSTRACT. Increased longevity and subsequent increase in older populations emphasize the importance of assisting older people to continue living in safe and residential situations for as long as possible. Judgement, an important aspect of cognition, and a predictor of function may become impaired and compromise safe living. Yet, judgement is difficult to assess, and few valid instruments are utilized in clinical settings that accurately evaluate judgement in older people. Objectives: This pilot study aimed to translate, culturally adapt, and initiate the validation of the Hebrew version of the verbal practical judgement (VPJ) assessment among community-dwelling older people. Methods: A total of 50 older adults, aged over 65 years, living in the community in Israel, half of whom were independent (n=27, 54%), and the rest dependent participants in a day centre with some level of cognitive/functional decline, completed the VPJ evaluation and comparison assessments. Results: Positive and significant (p

Introduction: Hip fractures are a common frailty injury affecting a vulnerable geriatric population. It is debated if anesthetic and analgesic techniques are associated with altered risk for outcomes in hip fracture patients. This study aimed to determine the association of anesthesia and regional analgesia with all cause 12-month mortality and even longer-term mortality after hip fracture surgery in Australia and New Zealand.Methods: Data from the Australian and New Zealand Hip Fracture Registry collected from 2016 to 2018, with a minimum follow-up of 12 months, were reviewed. Anesthesia type and use of regional nerve blocks were investigated. The primary outcome was all cause 12-month mortality.Results: 12-month mortality was 30.6% (n=5410) in a total of 17,635 patients. There was no difference in 12-month mortality between patients who received spinal or general anesthesia (p=0.238). The administration of a combination of general and spinal anesthesia for surgery to repair the fracture was an independent predictor of higher 12-month mortality (unadjusted complete case HR=1.17 (95% CI 1.04 to 1.31); p<0.001). Nerve blocks performed in both the emergency department (ED) and the operating theater (OT) were associated with reduced long-term mortality (median follow-up 21 months) with an unimputed unadjusted HR=0.86 (95% CI 0.77 to 0.96; p=0.043).Conclusion: There was no difference in the association of 12-month mortality between general and spinal anesthesia in patients undergoing hip fracture surgery. However, there was an association with a higher risk of 12-month mortality in patients who received both general and spinal anesthesia for the same surgery. Patients who received a regional nerve block in both the ED and the OT had a lower association of 12-month and longer-term mortality risk. The reasons for these findings remain unknown and should be the subject of further research investigation. [ABSTRACT FROM AUTHOR]

Objectives: Diagnosis of cardiac sarcoidosis (CS) without histological evidence remains controversial. This study aimed to compare characteristics and outcomes of histologically proven versus clinically diagnosed cases of CS, which were adjudicated using Heart Rhythm Society or Japanese Circulation Society criteria.Methods: A total of 512 patients with CS (age: 62±11 years, female: 64.3%) enrolled in the multicentre registry were studied. Histologically confirmed patients were classified as 'biopsy-proven CS', while those with the presence of strongly suggestive clinical findings of CS without histological evidence were classified as 'clinical CS'. Primary outcome was a composite of all-cause death, heart failure hospitalisation and ventricular arrhythmia event.Results: In total, 314 patients (61.3%) were classified as biopsy-proven CS, while 198 (38.7%) were classified as clinical CS. Patients classified under clinical CS were associated with higher prevalence of left ventricular dysfunction, septal thinning, and positive findings in fluorodeoxyglucose-positron emission tomography or Gallium scintigraphy than those under biopsy-proven CS. During median follow-up of 43.7 (23.3-77.3) months, risk of primary outcome was comparable between the groups (adjusted HR: 1.24, 95% CI: 0.88 to 1.75, p=0.22). Similarly, the risks of primary outcome were comparable between patients with clinical isolated CS who did not have other organ/tissue involvement, and biopsy-proven isolated CS (adjusted HR: 1.23, 95% CI: 0.56 to 2.70, p=0.61).Conclusions: A substantial number of patients were diagnosed with clinical CS without confirmatory biopsy. Considering the worse clinical outcomes irrespective of the histological evidence, the diagnosis of clinical CS is justifiable if imaging findings suggestive of CS are observed. [ABSTRACT FROM AUTHOR]

Background and Objectives: Stacked proportional bar graphs (nicknamed "Grotta bars") are commonly used to visualize functional outcome scales in stroke research and are also used in other domains of neurology research. While lending themselves to a straightforward causal interpretation in ideal randomized controlled trials, in observational studies, Grotta bars cannot be generally interpreted causally if they show unadjusted, confounded comparisons. In a sample of recent observational neurology studies with confounding-adjusted effect estimates, we aimed to determine the frequency with which Grotta bars were used to visualize functional outcomes and how often unadjusted Grotta bars were presented without an accompanying adjusted version. We also assessed the methods used to generate adjusted Grotta bars., Methods: We identified the 15 top-ranked clinical neurology journals, according to journal impact factor, publishing full-length original research in English. Using PubMed, we retrieved all records published in these journals between 2020 and 2021 after applying a filter for observational studies. We included and systematically examined all observational studies aiming to identify a cause-and-effect relationship with an ordinal functional outcome and confounding-adjusted effect estimate. We determined whether at least 1 comparison using Grotta bars was present, whether the visualized comparisons were adjusted, and which adjustment strategies were applied to generate these graphs., Results: A total of 250 studies met all inclusion criteria. Of these, 93 (37.2%) used Grotta bars to depict functional outcome scale distributions, with 76 (81.7%) presenting only Grotta bars without model-based adjustment. These bars were most commonly presented in studies with stroke patient populations; 87 of 192 studies (45.3%) presented Grotta bars. Among the 17 studies that presented Grotta bars adjusted using a model, the adjustment strategies included propensity score matching (n = 10; 58.8%), regression (n = 6; 35.3%), and inverse probability weighting (n = 1; 5.9%)., Discussion: Studies that presented adjusted associations for functional outcomes commonly showed only unadjusted Grotta bars, which alone have little value for causal questions. In observational research, Grotta bars are most informative if an adjusted version, aligning with adjusted effect estimates, is presented directly alongside the unadjusted version. Based on our findings, we offer recommendations to help authors generate more informative Grotta bars and to facilitate correct interpretation for readers.

Background and Objectives: Ordinal scales are widely adopted as outcome measures in neurologic randomized controlled trials (RCTs). We aimed to evaluate which statistical methods have been used to test and estimate treatment effects from ordinal outcomes in recent RCTs across a range of acute neurologic diseases., Methods: We searched PubMed for RCTs in 5 acute monophasic neurologic diseases (stroke, traumatic brain injury [TBI], subarachnoid hemorrhage [SAH], meningitis, and Guillain-Barré syndrome [GBS]) published in high-impact journals between January 1, 2015, and November 1, 2023. Trials had to report on an ordinal scale as the primary or secondary efficacy outcome. Two independent reviewers performed study screening and data extraction. We evaluated the results to determine how investigators (1) addressed the ordinal nature of outcomes, (2) assessed and reported key assumptions, (3) used longitudinal measurements, and (4) adjusted for prognostic covariates., Results: We reviewed 70 RCTs for treatment evaluations in stroke (n = 36), TBI (n = 13), SAH (n = 10), meningitis (n = 7), and GBS (n = 4). In 46 of 70 trials (66%), investigators retained the full ordering information, commonly analyzed using a proportional odds model (33/46 trials, 72%). The proportional odds assumption was not addressed in 23 of 33 trials (62%). In 22 of 70 trials (31%), the ordinal outcome was dichotomized, with notable variation in the cut-point for each ordinal scale. In 41 of 70 trials (59%), the ordinal outcome was assessed at multiple time points while some form of longitudinal data analysis was performed in only 3 of these 41 studies (7%). The time point chosen for analysis varied within neurologic conditions. Covariate adjustment was reported in 48 of 70 studies (69%)., Discussion: There is a large variation in the current practice of analyzing ordinal outcomes in neurologic trials. Dichotomization and focus on a single time point are common; therefore, information contained in the rank ordering of the outcome and repeated measurements is not fully used. Further research needs to clarify the balance between maximizing the statistical power, making assumptions, and allowing for straightforward interpretations in approaches that make more effective use of the outcome data.

Artificial intelligence (AI) is revolutionizing stroke care by enhancing diagnosis, treatment, and outcome prediction. This review examines 505 original studies on AI applications in ischemic stroke, categorized into outcome prediction, stroke risk prediction, diagnosis, etiology prediction, and complication and comorbidity prediction. Outcome prediction, the most explored category, includes studies predicting functional outcomes, mortality, and recurrence, often achieving high accuracy and outperforming traditional methods. Stroke risk prediction models effectively integrate clinical and imaging data, improving assessments of both first-time and recurrent stroke risks. Diagnostic tools, such as automated imaging analysis and lesion segmentation, streamline acute stroke workflows, while AI models for large vessel occlusion detection demonstrate clinical utility. Etiology prediction focuses on identifying causes such as atrial fibrillation or cancer-associated thrombi, using imaging and thrombus analysis. Complication and comorbidity prediction models address stroke-associated pneumonia and acute kidney injury, aiding in risk stratification and resource allocation. While significant advancements have been made, challenges such as limited validation, ethical considerations, and the need for better data collection persist. This review highlights the advancements in AI applications for addressing key challenges in stroke care, demonstrating its potential to enhance precision medicine and improve patient outcomes.

Objective: Out-of-hospital cardiac arrest (OHCA) is a major public health challenge across Europe, with a survival rate of only 8.5% to hospital discharge. Implementing a community first responder (CFR) system, including earlier Basic Life Support and defibrillation, can enhance survival rates and neurological outcomes. This study assesses the cost-effectiveness of two scenarios for implementing such a system in Belgium., Methods: A decision tree and the long-term Markov model were used to evaluate cost-effectiveness by comparing two scenarios with current care standards. Scenario 1 involved an awareness campaign on OHCA, while Scenario 2 included implementing a CFR system with automated external defibrillator (AED) integration, dispatch centre linkage and training for citizen responders. The analysis covered survival to the emergency department, hospital, discharge and neurologically intact survival, with sensitivity analyses to test robustness., Results: The awareness campaign and implementation of the CFR system resulted in an incremental cost-effectiveness ratio of €14,976 and €16,442 per quality-adjusted life year gained for scenarios 1 and 2, respectively. Both scenarios showed improvements in survival rates at various stages, including hospital discharge and neurologically intact survival., Conclusion: This study highlights the benefits of enhancing Belgium's CFR for OHCA patients. It suggests that accessible AEDs, trained CFRs and an integrated emergency response system could improve survival rates and quality of life. These findings can guide policy and resource decisions, potentially improving the effectiveness and cost-efficiency of OHCA emergency services. Additionally, this approach could serve as a model for other regions aiming to strengthen their response to time-sensitive emergencies., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Background: Cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia. However, scaling this proven effective intervention to areas of high need remains a challenge, necessitating sensitive adaptation and evaluation., Methods: A randomised waitlist-controlled trial evaluated the efficacy of a hybrid digital CBT-I and emotion regulation (dCBT-I + ER) intervention delivered through workplaces. Participants with at least mild insomnia and depression or anxiety symptoms were randomised to the intervention or waitlist control groups. The intervention was delivered via a web-based platform and four video-conferencing therapy sessions. Participants tracked their sleep using actigraphy and a sleep diary that was used to pace the intervention delivered. Assessments occurred at baseline and 8 weeks post-randomisation, measuring insomnia, depression, anxiety, psychological well-being, quality of life, and work productivity., Results: Of the 159 participants (mean age 43.6 ± 9.4 years, 76.7% female, 80.5% white), 80 received the intervention and 79 were in the control group. The intervention group showed significant improvements in insomnia (F1, 134 = 71.46, p < .0001); depression (F1, 134 = 35.67, p < .0001); and anxiety (F1, 134 = 17.63, p < .0001), with large effect sizes (d = 0.7-1.5). Sleep diary data supported these findings, whereas actigraphy data did not. Improvements in psychological well-being were significant (F1, 132.13 = 10.64, p < 0.001), whereas quality of life, work productivity, and satisfaction outcomes were not., Conclusions: This study suggests that a hybrid dCBT-I + ER intervention, delivered via workplaces, effectively improves insomnia, depression, and anxiety. It holds promise as a scalable solution, warranting further investigation into its long-term efficacy and economic impact.

Introduction: Achalasia is a rare disease in children. Studies investigating the efficacy of interventions and disease outcomes in paediatric achalasia are predominantly retrospective, consist of small cohorts and report heterogeneous outcomes. The variation in the use and definition of reported outcomes impedes meta-analysis, which is problematic in a rare paediatric condition. Similarly, there is a risk of under-reporting patient-relevant outcomes, such as quality of life. To overcome these issues, a minimum set of important and patient-relevant outcomes should be reported in all studies of paediatric achalasia. Core outcome sets (COS) are a standardised set of outcomes that can guide further research and facilitate data pooling and meta-analysis. The development of a COS in rare paediatric disease is essential, prior to conducting efficacy studies or creating a disease registry, to ensure that the most important outcomes are reported. Currently, no COS exists for children with achalasia. In this study, we aim to define a COS for paediatric achalasia for use in clinical research., Methods and Analysis: This study will consist of three parts. The first will be a systematic review of the literature, evaluating the outcomes and outcome definitions reported in published clinical research studies investigating paediatric achalasia. Second, a three-stage Delphi consensus process will be undertaken to identify and prioritise outcomes. This process will involve healthcare professionals, patients and parent representatives. Third, a consensus meeting will be held, during which the final COS will be defined., Dissemination: The results of this study will be disseminated to stakeholders via the European Reference Network for Rare Inherited Congenital Anomalies, European Society for Pediatric Gastroenterology Hepatology and Nutrition, European Paediatric Surgeons' Association, and patient groups. The COS will be published in a peer-reviewed journal and uploaded to the Core Outcome Measures in Effectiveness Trials (COMET) initiative website., Trial Registration Number: The study was pre-registered with the COMET initiative in July 2024 (https://www.comet-initiative.org/Studies/Details/2568). The systematic review component of the study was pre-registered on PROSPERO (CRD42024509855)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Anifrolumab (Saphnelo) is approved for adult patients with moderate-severe systemic lupus erythematosus (SLE). Considering its commercialisation in Spain in 2023, observational studies describing the use of anifrolumab in routine clinical practice are limited. The aim of the AZAHAR study is to describe the characteristics and clinical outcomes of patients with SLE who initiated anifrolumab during its first year of marketing in Spain., Methods and Analysis: This is an observational retrospective study including ~120 patients with moderate-severe SLE who received anifrolumab in Spain in 20 centres from 1 June 2023 to 31 May 2024. Patients will be followed up every 6 months after the first infusion of anifrolumab for a period between 6 and 18 months until the end of the study (31 December 2024). Data will be obtained through the review of medical records, considering as primary outcomes disease activity measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000, clinical SLEDAI, Physician Global Assessment and Lupus Low Disease Activity State and remission, defined by Definitions of Remission in SLE-21, and as secondary outcomes, SLE treatment, flare incidence, anifrolumab adherence and persistence (time on treatment) and healthcare resources utilisation., Ethics and Dissemination: The final protocol of the study will be approved by ethics committees/institutional review boards (IRB)/independent ethics committees at each site., Trial Registration Number: NCT06626945., Competing Interests: Competing interests: NB-R, BS-F and MG-F are current employees of AstraZeneca Spain., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Objective: Disease activity both between and within patients with SLE is highly variable, yet factors driving this variability remain unclear. This study aimed to identify predictors of variability in SLE disease activity over time., Methods: We analysed data from 2930 patients with SLE across 13 countries, collected over 38 754 clinic visits between 2013 and 2020. Clinic visit records were converted to panel data with 1-year intervals. The time-adjusted mean disease activity, termed AMS , was calculated. The yearly change in [Formula: see text], denoted as [Formula: see text], was regressed onto [Formula: see text] and other potential predictors using random-effects models. Some variables were split into a person-mean component to assess between-patient differences and a demeaned component to assess within-patient variability., Results: Overall, variability in SLE disease activity exhibited stabilisation over time. A significant inverse relationship emerged between a patient's disease activity in a given year and variability in disease activity in the subsequent year: a 1-point increase in person-mean disease activity was associated with a 0.27-point decrease (95% CI -0.29 to -0.26, p<0.001) in subsequent variability. Additionally, a 1-point increase in within-patient disease activity variability was associated with a 0.56-point decrease (95% CI -0.57 to -0.55, p<0.001) in the subsequent year. Furthermore, each 1-point increase in the annual average time-adjusted mean Physician Global Assessment was associated with a 0.08-point decrease (90% CI -0.13 to -0.03, p=0.002) in disease activity variability for the following year. Prednisolone dose and the duration of activity in specific organ systems exhibited negative and positive associations, respectively, with disease activity variability in the subsequent year. Patients from less affluent countries displayed greater disease activity variability compared with those from wealthier nations., Conclusion: Disease activity tends to be less variable among patients with higher or more variable disease activity in the previous year. Within-patient variability in disease activity has a stronger impact on subsequent fluctuations than differences between individual patients., Competing Interests: Competing interests: NL’s salary from Monash University was partly supported by a research grant from BMS. AH has received a research grant from AstraZeneca, consulting fees from EUSA Pharma (UK), GSK and UCB Australia and speaker fees/honoraria from AbbVie, Eli Lilly, Janssen, Limbic, Moose Republic and Novartis. SS has received consulting fees from Pfizer, AstraZeneca and ZP Therapeutics. MN has received an investigator grant from the National Health and Medical Research Council of Australia (NHMRC GNT1176538), research grants from Boehringer Ingelheim and Janssen, consulting fees from AstraZeneca and GSK, honoraria for presentations from AstraZeneca, Boehringer Ingelheim and GSK and support for conference attendance from Boehringer Ingelheim. SO has received speaker fees/honoraria from AstraZeneca and Limbic. ZL has received consulting fees from Pfizer, Roche, Janssen, Abbott, AbbVie, Bristol Myers Squibb, MSD, Celgene, Eli Lilly, GSK, Novartis and UCB Pharma, and holds royalties with these companies. SN has received consulting and lecture/speaker fees from AstraZeneca, Biogen and Boehringer Ingelheim and is a non-paid member of Viatris (Idorsia) Advisory Board. YK has received payment/honoraria from GlaxoSmithKline KK, AstraZeneca KK, Sanofi KK, Pfizer Japan, Janssen Pharmaceutical KK, Chugai Pharmaceutical, Asahi Kasei Pharma, Astellas Pharma and Mitsubishi Tanabe Pharma. MH has received payment for postmarketing surveillance from GlaxoSmithKline KK, a research grant from Novartis Pharma, and honoraria for lectures from GlaxoSmithKline KK, AstraZeneca KK and Astellas Pharma. FG was a Director on the Board of the Australian Rheumatology Association at the time of the study. ZZ has received payment/honoraria from AbbVie, AstraZeneca KK, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, GSK, Novartis, Pfizer, Roche, Sanofi, Janssen and UCB Pharma, and has participated in advisory boards for BeiGene. TT has received consultancy fees from AstraZeneca, Kowa and Mitsubishi Tanabe. KN has received speaker fees from Novartis. YT has received speaker fees and/or honoraria from AbbVie, Eisai, Chugai, Eli Lilly, Boehringer Ingelheim, GlaxoSmithKline, Taisho, AstraZeneca, Daiichi-Sankyo, Gilead, Pfizer, UCB, Asahi Kasei and Astellas, and received research grants from Boehringer Ingelheim, Taisho and Chugai. Y-HC has received advisory board fees and honoraria from Pfizer, Novartis, AbbVie, Johnson & Johnson, BMS, Roche, Lilly, GSK, AstraZeneca, Sanofi, MSD, Guigai, Astellas, Inova Diagnostics, UCB, Agnitio Science Technology, United Biopharma, Thermo Fisher, Gilead, Eisai and CSL Behring, as well as research grants from the Taiwan Ministry of Science and Technology, Taiwan Department of Health, Taichung Veterans General Hospital, National Yang-Ming University, GSK, Pfizer, BMS, Roche and AstraZeneca, and Medigen Vaccine Biologics. JChoi is an employee of BMS. RK-R has received grants from GSK and Novartis. EM has received consulting fees from AbbVie, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, EMD Serono, Genentech, Gilead, Janssen, Novartis, Takeda and UCB., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Current treatment modalities of lumbar spinal stenosis range from conservative medical management and physical therapy to open surgical decompression. Minimally invasive lumbar decompression (MILD) and Superion interspinous spacers (SISS) Vertiflex offer the promise of effective pain relief with shorter recovery time and lesser potential complications compared with open surgical decompression procedures and general anesthesia. Despite their increasing utilization, their complication profile is not well established in the literature., Methods: We searched the FDA's Manufacturer and User facility Device Experience (MAUDE) database for all entries on MILD product code 'HRX' and SISS product code 'NQO'. MAUDE database was queried from 2010 to 2021. Duplicate entries were removed, and complications were classified based on the event descriptions., Results: For the MILD procedure, a total of 10 entries were found in the MAUDE database. Among these, 8 were classified as surgical complications and 2 were device related. On the other hand, a total of 919 reports were found in the MAUDE database for Vertiflex, with 385 medical device reports were included in the analysis. Device-related were the most reported complication, accounting for 189 cases., Conclusion: As with any new intervention, we must proceed with caution and evaluate the procedure performance over time. Such data should aid physicians to make informed decisions before choosing either technique for their patients. The findings from this study provide insight into the complication profile associated with both MILD and Vertiflex procedures, highlighting the need for continued evaluation and careful consideration in clinical decision-making., Competing Interests: Competing interests: NM: Research Support; Mesoblast; Neuros Medical and Vivex Biologics. Consultancy as Medical Monitor for: Saluda Medical, Nevro, Vivex Biologics, Mainstay, Sollis Therapeutics, and Vertos. SC: Research Support: ECAP Trial, Saluda; MOTION Trial, Vertos; RESTORE Trial, Mainstay Medical; ViaDisc-NP Trial, Vivex Therapeutics., (© American Society of Regional Anesthesia & Pain Medicine 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Background: Cognitive impairment is a core feature of Huntington's disease (HD), yet no disease-modifying or symptomatic interventions have demonstrated efficacy in addressing these deficits. Non-pharmacological interventions, particularly cognitive training (CT), are promising options for maintaining neural plasticity, enhancing cognition, and improving emotional well-being., Methods: This 24-week, single-center, randomized, single-blind study evaluated the safety and efficacy of two cognitive rehabilitation strategies in early-to-middle-stage HD patients. Participants were randomized into a computerized cognitive training (CT; n = 13) intervention or a music therapy (MT; n = 16) intervention. A standard of care (SoC; n = 15) group with no active intervention was also involved. Weekly 45-min sessions were conducted. Baseline and endpoint assessments included measures of global cognition, functional, motor, and neuropsychiatric assessments, along with structural and functional neuroimaging., Results: Both CT and MT groups demonstrated significant improvements in primary and secondary cognitive endpoints, including global cognition an composite measures of disease severity. Regression analysis identified longitudinal cognitive score changes as independent predictors of the rate of atrophy in the caudate, putamen, and inferior frontal gyrus. Functional connectivity analysis showed distinct intervention-related effects: CT group exhibited increased connectivity between the central executive and sensorymotor networks, while MT group reduced aberrant connectivity between the central executive and the default-mode network., Conclusion: This is the first randomized-controlled trial to evaluate two cognitive rehabilitation strategies in HD using multimodal neuroimaging. Both interventions were effective in improving cognition and modulating structural and functional brain changes in regions critical to HD. Trial Registration ClinicalTrials.gov (ID: NCT05769972)., Competing Interests: Declarations. Ethical approval: The present study has been approved by the Hospital de la Santa Creu i Sant Pau ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Informed consent was obtained from all participants prior to their inclusion in the study. Conflict of interests: A.P.-D. is supported by a grant from the Government of Andorra (ATC027-AND/2021). S.M.-H. has received honoraria for lecturing from Teva, Zambon, UCB, Bial, and Roche, and reports grants from Huntington’s disease Society of America (Human Biology Project), and from Fondo de Investigaciones Sanitarias (FIS) from Instituto de Salud Carlos III (ISCIII). J.P.-P. reports a grant from Fondo de Investigaciones Sanitarias (FIS) from Instituto de Salud Carlos III (ISCIII). JP has received honoraria for advisory boards or lecturing from: Teva, Zambon, UCB, Bial, Sanofi, and Roche. J.K. has received honoraria for advisory boards or lecturing from: Teva, Zambon, UCB, Bial, General Electric, Sanofi, and Roche, and reports grants from Fundació la Marato de TV3, Fondo de Investigaciones Sanitarias (FIS) from Instituto de Salud Carlos III (ISCIII), and Fondo Europeo de Desarrollo Regional (FEDER). The authors declare that there is no conflict of interest regarding the publication of this article. The research group also receives funds from CERCA (CEntres de Recerca de CAtalunya) and CIBERNED (Centro de Investigación Biomédica en Red de enfermedades NEuroDegenerativas)., (© 2025. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Harmonizing core outcome domains allows for pooling data, comparing interventions, and streamlining research evaluation. At the same time clinicians require concise and feasible measures for routine practice. Considering the heterogeneity of post-COVID-19 condition, a biopsychosocial approach requires sufficient coverage of the psychosocial dimension with assessments. Previous recommendations for core outcome sets have serious limitations regarding the psychosocial aspects of post-COVID-19 condition. This paper specifically focuses on psychosocial outcomes for adults with post-COVID-19 condition, providing both a comprehensive set of outcome domains for research and a streamlined clinical core set tailored for routine clinical use., Methods: In a structured Consensus Development Approach, the European Network to improve diagnostic, treatment, and healthcare for patients with persistent somatic symptoms (EURONET-SOMA) developed psychosocial core outcome domains and assessments regarding post-COVID-19 condition. The experts identified variables and instruments which should be considered in studies on adults suffering from post-COVID-19 condition, and which are feasible in the clinical setting and relevant for research., Results: We identified three higher-order dimensions with each encompassing several domains: The first higher-order dimension, "outcomes", encompasses (1) the classification/ diagnostics of post-COVID-19 condition, (2) somatic symptoms (including fatigue), (3) the psychopathological status and mental comorbidities, (4) the physical status and somatic comorbidities, (5) neurocognitive symptoms, and (6) illness consequences. The second higher-order domain "mechanisms" encompasses (7) cognitive components, (8) affective components, (9) behavioral components, (10) social components, and (11) psychobiological bridge markers (e.g., neuroimmunological and psychoneuroendocrinological variables). The third higher-order domain, "risk factors", includes factors such as (12) socioeconomic status and sociocultural factors, (13) pre-existing mental and somatic health issues, (14) personality factors (e.g., neuroticism), (15) adverse childhood experiences, (16) ongoing disability or pension claim, and (17) social media use. For each domain, specific instruments are suggested for research purposes and clinical use., Conclusions: The recommended core domains help to increase consistency in a biopsychosocial approach to post-COVID-19 condition across investigations, improve synergies, and facilitate decision-making when comparing different interventional approaches. It allows to better identify relevant subgroups in heterogeneous post-COVID-19 condition populations offering practical tools for routine clinical practice through the clinical core set., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: LdV declares that this paper was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. PE reports research funding (no personal honoraria) from the German Research Foundation. KH is a co-leader of the network post COVID Tyrol, part of the Austrian task force on postviral illnesses and has received speaker honoraria from KRKA pharma. BL reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the European Commission’s Horizon 2020 Framework Programme, the European Joint Programme for Rare Diseases (EJP), the Ministry of Science, Research and Equality of the Free and Hanseatic City of Hamburg, Germany, and the Foundation Psychosomatics of Spinal Diseases, Stuttgart, Germany. He has received remunerations for several scientific book articles from various book publishers, from the Norddeutscher Rundfunk (NDR) for interviews in medical knowledge programmes on public television, and as a committee member from Aarhus University, Denmark. He received travel expenses from the European Association of Psychosomatic Medicine (EAPM), and accommodation and meals from the Societatea de Medicina Biopsyhosociala, Romania, for a presentation at the EAPM Academy at the Conferința Națională de Psihosomatică, Cluj-Napoca, Romania, Oct 2023. He received remuneration and travel expenses for lecture at the Lindauer Psychotherapiewochen, April 2024. He is President of the German College of Psychosomatic Medicine (DKPM) (unpaid) since March 2024 and was a member of the Board of the European Association of Psychosomatic Medicine (EAPM) (unpaid) until 2022. AT reports research funding (no personal honoraria) from the German Research Foundation, and royalties from book publishers. WR declares to have received honoraria from Boehringer Ingelheim for conducting workshops, and royalties from book publishers. RvK declares to have received honoraria from CSL Vifor and Heel for attending Scientific Advisory Boards, and royalties from book publishers. SS reports research funding (no personal honoraria) from the German Research Foundation and the German Heart Foundation/German Foundation of Heart Research. RS declares that he has received funding in the context of a Horizon Europe project on Long COVID (https://longcovidproject.eu/) from the Swiss State Secretariat for Education, Research and lnnovation (SERI) under contract number 22.00094 and a lecture honorarium from Novarits. UW declares that she has received lecture honoraria from Lundbeck and Janssen and has served/serves on scientific committees for Janssen and Teva, receiving honoraria for these activities. All other authors declare that they have no competing interest., (© 2025. The Author(s).)

The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network indexes over 600 reporting guidelines designed to improve the reproducibility of manuscripts across medical fields and study designs. Although several such reporting guidelines touch on adverse events that may occur in the context of a study, there is a large body of research whose primary focus is on adverse events, near-misses and medical errors that do not currently have a dedicated reporting guideline to help set reporting standards and facilitate comparisons across studies. As part of the process prescribed by EQUATOR for developing such a reporting guideline, we performed a needs assessment, evaluating whether existing standards address key features of a proposed reporting guideline in development, entitled Standard Elements in Studies of Adverse Events and Medical Error (SESAME). We evaluated 12 EQUATOR reporting guidelines for the presence of eight key features of SESAME. Five of the 12 failed to include any of these key features. None of the remaining seven incorporated more than four of the eight SESAME key components, confirming the need for a dedicated reporting guideline for studies of adverse events and medical errors., Competing Interests: Competing interests: CRC is the Deputy Editor-in-Chief of Academic Emergency Medicine, Associate Editor, Annals of Internal Medicine’s ACP Journal Club, and Associate Editor, Journal of the American Geriatrics Society. CRC serves on the American College of Emergency Physicians Clinical Policy Committee and the American Board of Emergency Medicine, as an MyEMCert Editor. DCS is the Chief Clinical Officer, Emeritus & Chair, Clinical Advisory Council of Pascal Metrics, a federally certified Patient Safety Organization. RTG is supported by grant 1 R01 HS027811-01 from the Agency for Healthcare Research and Quality (AHRQ). The contents of this work are solely the responsibility of the authors and do not necessarily represent the official view of the AHRQ., (© Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Background: In this qualitative study, we aimed to obtain and synthesise the views of patients with functional neurological disorder (FND), their caregivers, and relevant healthcare professionals (HCPs) on outcome measurement in FND., Methods: Semi-structured interviews were conducted with 22 FND patients, 18 caregivers and 21 HCPs, sampled purposively in the United Kingdom. Transcripts were analysed through inductive thematic analysis., Results: Whilst reduction or resolution of FND symptoms were frequently mentioned as important treatment goals in all groups, this was reported by a larger proportion of caregivers and HCPs than patients. Patients most frequently hoped for improvements in mental health/well-being. Other important treatment goals were resuming work, and an increase in independence, self-management or self-efficacy. Of the 20 domains deemed relevant for outcome assessment, improvements in FND symptoms, emotional well-being, activities of daily living and quality-of-life, were mentioned most frequently. None of the participants thought that outcome assessment should be purely clinician-rated or objective; all believed that the patient's subjective experience should be central. Nevertheless, participants in all groups acknowledged that clinician-rated or objective OMIs have added value in clinical outcome assessment. The benefits of digital outcome assessment were also mentioned by several participants., Conclusions: This is the first study to capture the views of key stakeholders on outcome assessment in FND. The findings indicate that outcome measures for FND should be patient-centred, whilst also including HCP opinion. Critical domains for assessment are FND symptoms, mental health, quality-of-life and the ability to perform activities of daily living., Competing Interests: Declarations. Competing interests: The authors have no relevant financial or non-financial interests to disclose., (© 2025. The Author(s).)

Background: Data on variation in outcomes and costs of the treatment of inflammatory bowel disease (IBD) can be used to identify areas for cost and quality improvement. It can also help healthcare providers learn from each other and strive for equity in care. We aimed to assess the variation in outcomes and costs of IBD care between hospitals., Methods: We conducted a 12-month cohort study in 8 hospitals in the Netherlands. Patients with IBD who were treated with biologics and new small molecules were included. The percentage of variation in outcomes (following the International Consortium for Health Outcomes Measurement standard set) and costs attributable to the treating hospital were analyzed with intraclass correlation coefficients (ICCs) from case mix-adjusted (generalized) linear mixed models., Results: We included 1010 patients (median age 45 years, 55% female). Clinicians reported high remission rates (83%), while patient-reported rates were lower (40%). During the 12-month follow-up, 5.2% of patients used prednisolone for more than 3 months. Hospital costs (outpatient, inpatient, and medication costs) were substantial (median: €8323 per 6 months), mainly attributed to advanced therapies (€6611). Most of the variation in outcomes and costs among patients could not be attributed to the treating hospitals, with ICCs typically between 0% and 2%. Instead, patient-level characteristics, often with ICCs above 50%, accounted for these variations., Conclusions: Variation in outcomes and costs cannot be used to differentiate between hospitals for quality of care. Future quality improvement initiatives should look at differences in structure and process measures of care and implement patient-level interventions to improve quality of IBD care., Trial Registration Number: NL8276., (© 2024 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)

Background: Few studies have examined the long-term outcomes of first-episode psychosis (FEP) among patients beyond symptomatic and functional remission. This study aimed to broaden the scope of outcome indicators by examining the relationships between 12 outcomes of FEP patients at 20.9 years after their initial diagnosis., Methods: At follow-up, 220 out of 550 original patients underwent a new assessment. Twelve outcomes were assessed via semistructured interviews and complementary scales: symptom severity, functional impairment, personal recovery, social disadvantage, physical health, number of suicide attempts, number of episodes, current drug use, dose-years of antipsychotics (DYAps), cognitive impairment, motor abnormalities, and DSM-5 final diagnosis. The relationships between these outcome measures were investigated using Spearman's correlation analysis and exploratory factor analysis, while the specific connections between outcomes were ascertained using network analysis., Results: The outcomes were significantly correlated; specifically, symptom severity, functioning, and personal recovery showed the strongest correlations. Exploratory factor analysis of the 12 outcomes revealed two factors, with 11 of the 12 outcomes loading on the first factor. Network analysis revealed that symptom severity, functioning, social disadvantage, diagnosis, cognitive impairment, DYAps, and number of episodes were the most interconnected outcomes., Conclusion: Network analysis provided new insights into the heterogeneity between outcomes among patients with FEP. By considering outcomes beyond symptom severity, the rich net of interconnections elucidated herein can facilitate the development of interventions that target potentially modifiable outcomes and generalize their impact on the most interconnected outcomes.

Competing Interests: Competing interests: None declared.

Purpose: The Outcome Monitoring After Cardiac Surgery (OMACS) cohort study was set-up with the aim of establishing a rich source of biological samples and health status data from patients who undergo cardiac surgery. The objectives were to use these data to inform the design of new clinical studies and to provide samples and data to answer research questions., Participants: Recruitment began on 23 May 2016 and ended 31 May 2022. Adult patients undergoing cardiac surgery at University Hospitals Bristol and Weston NHS Foundation Trust were screened and approached for consent. Participants could optionally consent to provide biological samples (urine, blood and waste tissue) in addition to data. A total of 4068 patients consented to participate in the study with 2027 consenting to donate samples. Participants were sent quality-of-life follow-up questionnaires at 3 and 12 months after surgery. The clinical data were collected from hospital records/databases., Findings to Date: The OMACS population appears to be representative of the wider cardiac surgery population with similar preoperative demography to those reported on the UK surgery population. To date, eight studies have been carried out by research teams using data from a total of 1165 OMACS participants. Two Studies Within A Trial have been performed by the OMACS study team. The format of the study patient information leaflet was not significantly associated with an increased recruitment rate, and an alternative theory-informed cover letter included with the 12-month follow-up questionnaires was not associated with an increase in questionnaire completion. Additional exploratory research carried out within the OMACS study has been presented at international conferences., Future Plans: The OMACS study is now closed. The cohort's data and samples will be available to share with researchers, providing an opportunity to answer a variety of research questions (eg, evaluating predictors of adverse outcomes after cardiac surgery such as biomarkers, surgical methods and pre-existing conditions). The data and samples will be available for sharing in a linked anonymised format., Trial Registration Number: ISRCTN90204321 (date assigned: 21 January 2015)., Competing Interests: Competing interests: While working on the project KJ, RM, TW-S, HS, CAR, BR, RB and LC were all employed by the CTU that was in receipt of NIHR BRC and NIHR CTU funding. All other authors have no competing interest to declare, (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.)

Background: Tension-type headache (TTH) is the most common type of headache and the second most common health-related complaint among children and adults. Traditional Chinese medicine (TCM) offers unique therapeutic benefits in treating TTH. However, the lack of standardized evidence-such as inconsistencies in outcome selection and reporting in clinical studies, a lack of consensus on outcomes and measures, high risks of selective reporting bias, and missing data-has limited the development of robust evidence supporting the efficacy of TCM in treating TTH. Therefore, establishing a core outcome set (COS) is crucial for standardizing TCM clinical studies for TTH, thereby enhancing the quality and comparability of research findings., Objective: This study aims to develop a COS for future clinical studies on the treatment of TTH with TCM., Methods: The COS will be developed through the following 3 stages. First, systematic reviews and semistructured interviews will be conducted to identify potential essential outcomes, which will be evaluated by the steering committee to finalize a preliminary list of outcomes. Data will be processed using thematic analysis to ensure comprehensive coverage of relevant outcomes. Second, a 2-round Delphi survey will be conducted, inviting stakeholders, including health care experts and patients with tension-type headaches, to determine the importance of each outcome. Statistical analysis will be used to assess the level of consensus and prioritize outcomes based on predefined criteria. Third, a face-to-face consensus meeting will be held to finalize the COS and recommend measurement times for each outcome. Key outcomes will be interpreted based on their clinical relevance and feasibility of measurement, ensuring the COS is comprehensive and applicable in clinical settings., Results: The protocol has been registered in PROSPERO, with the review commencing on October 1, 2024, and anticipated results by November 15, 2024. The systematic reviews will be finalized, followed by the Delphi survey and consensus conference in late 2024 and early 2025. The COS findings will be reported per COS-STAR (Core Outcome Set-STAndards for Reporting) guidelines, published in an international journal, presented at conferences, and disseminated to participants for clinical application., Conclusions: This study is necessary as developing a COS for future TCM clinical studies in the treatment of TTH can maximize the value of data from individual trials and provide high-quality research evidence., Trial Registration: Core Outcome Measures in Effectiveness Trials Initiative 1473; https://tinyurl.com/3ts62s2p., International Registered Report Identifier (irrid): PRR1-10.2196/63481., (©Guojing Fu, Yunmeng Chen, Xiao Liang, Chunli Guo, Xueming Fan, Xiao Gong, Wenjie Chen, Jing Teng, Jun Tang, Xing Liao, Jingjing Wei, Yunling Zhang. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 05.02.2025.)