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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.

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]

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.

Abstract 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.

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.

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).

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 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

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]

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 .

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]

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: 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 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.

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

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 Objectives: to report the implementation and maintenance of an evidence-based Standard Operating Procedure for surgical counting performed at a teaching hospital. Methods: a report of a project to implement evidence for surgical counting, carried out at a university hospital in December 2017, and the subsequent cycles for better performance of the implemented organizational document and maintenance of better results until March 2022. Results: the report is divided into implementation project presentation and four other cycles after implementation, related to maintenance of improvements. It was possible to prepare a Standard Operating Procedure for Surgical Count, train the nursing team, carry out educational intervention for surgical teams. Final Considerations: there was an improvement in complying with the standardized procedure at the first moment and worsening in the period related to the pandemic. New efforts began again, including a self-instructive online course combined with first-time strategies.

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: Joint arthroplasties are among the most commonly performed elective surgeries in the United States. Surgical outcomes are known to improve with volume but it is unclear whether this has led to consolidation among elective surgeries. We examined trends in volumes per surgeon and hospital to assess whether the known volume-outcome relationship has led to consolidation in elective joint arthroplasty and to determine if there exist volume thresholds above which outcomes do not change.Methods: Among Medicare beneficiaries who underwent either total knee or total hip arthroplasty from 2009 through 2015, we described volume trends and used mixed-effect models to relate annual surgeon and hospital volumes with 30-day complications or mortality. We tested for optimal volume cut points at both the hospital and surgeon level.Results: Adjusted annual complication rates were inversely associated with volume for both procedures at both the surgeon level and hospital level, but there was minimal consolidation between 2009 and 2015. Complications no longer declined after volumes of each case exceeded 260 per year. The vast majority of cases (around 93% of hip and 88% of knee arthroplasties) were performed by surgeons operating at suboptimal volumes.Conclusion: More than 2 decades after the volume-outcome relationship was established for joint arthroplasty, many cases continue to be performed by low-volume surgeons, with far more cases performed by surgeons operating at suboptimal volumes. Further improvement could be expected through consolidation at both the hospital and surgeon level, with a target of at least 260 cases per surgeon annually for each operation. Payers seem best-equipped to drive consolidation. [ABSTRACT FROM AUTHOR]

Objective: To determine the independent impact of different definitions of remission and low disease activity (LDA) on damage accrual.Methods: Patients with ≥2 annual assessments from a longitudinal multinational inception lupus cohort were studied. Five mutually exclusive disease activity states were defined: remission off-treatment: clinical Systemic Lupus Erythematosus Disease Activity Index (cSLEDAI)-2K=0, without prednisone or immunosuppressants; remission on-treatment: cSLEDAI-2K score=0, prednisone ≤5 mg/day and/or maintenance immunosuppressants; low disease activity Toronto cohort (LDA-TC): cSLEDAI-2K score of ≤2, without prednisone or immunosuppressants; modified lupus low disease activity (mLLDAS): Systemic Lupus Erythematosus Disease Activity Index-2K score of 4 with no activity in major organ/systems, no new disease activity, prednisone ≤7.5 mg/day and/or maintenance immunosuppressants; active: all remaining visits. Only the most stringent definition was used per visit. Antimalarials were allowed in all. The proportion of time that patients were in a specific state at each visit since cohort entry was determined. Damage accrual was ascertained with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Univariable and multivariable generalised estimated equation negative binomial regression models were used. Time-dependent covariates were determined at the same annual visit as the disease activity state but the SDI at the subsequent visit.Results: There were 1652 patients, 1464 (88.6%) female, mean age at diagnosis 34.2 (SD 13.4) years and mean follow-up time of 7.7 (SD 4.8) years. Being in remission off-treatment, remission on-treatment, LDA-TC and mLLDAS (per 25% increase) were each associated with a lower probability of damage accrual (remission off-treatment: incidence rate ratio (IRR)=0.75, 95% CI 0.70 to 0.81; remission on-treatment: IRR=0.68, 95% CI 0.62 to 0.75; LDA: IRR=0.79, 95% CI 0.68 to 0.92; and mLLDAS: IRR=0.76, 95% CI 0.65 to 0.89)).Conclusions: Remission on-treatment and off-treatment, LDA-TC and mLLDAS were associated with less damage accrual, even adjusting for possible confounders and effect modifiers. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective: To evaluate the peri- and postoperative results and clinical repercussions in patients undergoing decompression surgery and single-level lumbar arthrodesis using the traditional technique (OTLIF) and to compare with the results of minimally invasive techniques (MITLIF) described in the literature. Methods: Our sample consisted of 22 patients who underwent TLIF surgery using the open technique (OTLIF) in the period October 2019 to January 2021, in our hospital. We compared the patients’ functional clinical results using the Oswestry scale in the preoperative period and 15 days after surgery, analyzed variables related to the perioperative period: surgery time, length of hospital stay, blood loss, use of a suction drain, and admission to the ICU, and compared these with the results reported in the literature for patients treated by the MITLIF technique. Results: The average age was 48.95 years and the most operated level was L4-L5 (55%). The average surgery time was 112.63 min. We did not use a suction drain in the postoperative period, there was no need for a blood transfusion in any patient, and no patient was admitted to the ICU. The average hospital stay was 1 day. Regarding the Oswestry Disability Index, the mean preoperative score was 44.73 and after 15 days, it was 24.05. Conclusions: surgical treatment using the OTLIF technique for single-level lumbar degenerative disease showed largely positive results, with improvement in disability scores, short hospital stay and low incidence of complications. When properly indicated, OTLIF is an excellent and safe option for the treatment of degenerative lumbar disease. Level of evidence IV; Case series study.

Objective: To assess the effect of early implementation of and longer daily duration of rehabilitation on patients with acute ischemic stroke who require assistance with activities of daily living (ADL) before hospital admission.Design: Nationwide, cohort, observational study from April 2018 to March 2019.Setting: Acute care hospitals in Japan.Participants: The Japanese national Diagnosis Procedure Combination database was searched for the period between April 2018 and March 2019. Of the 330,672 patients with ischemic strokes identified, 53,523 met the inclusion criteria of being older than 20 years, having a prehospital modified Rankin Scale score of 3, 4, or 5, and having undergone rehabilitation (N=53,523).Interventions: Not applicable.Main Outcome Measures: Improvement in ADL from admission to discharge using the Barthel Index. The effects of the following 3 rehabilitation variables on ADL improvement were evaluated: (1) average daily duration of rehabilitation; (2) rehabilitation started within 3 days after admission (early rehabilitation); and (3) rehabilitation started 1 day after admission (very early rehabilitation).Results: Early rehabilitation was significantly associated with improvements in ADL (odds ratio, 1.19; 95% confidence interval, 1.10-1.28; P≤.001). A longer duration of rehabilitation was also significantly associated with ADL improvement (≥2.0 hours: odds ratio, 2.49; 95% confidence interval, 2.26-2.75; P≤.001) compared with a ≤1 hour of rehabilitation (1.1-2.0 hours: odds ratio, 1.35; 95% confidence interval, 1.29-1.42; P≤.001).Conclusions: Early implementation of rehabilitation and a longer duration of rehabilitation per day improved the ADL of patients who required assistance before the onset of cerebral infarction.

Objectives: In AL amyloidosis, organ response assessment is based on surrogates (eg, cardiac biomarkers). An objective functional test, such as the 6 min walk test (6MWT), capturing overall clinical improvement, is required. We aimed to evaluate the prognostic impact of the 6MWT at baseline and change following chemotherapy.Methods: This study evaluated the outcomes of patients who enrolled in a prospective observational study at the UK National Amyloidosis Centre (2012-2017). Patients underwent comprehensive assessments inclusive of blood testing, echocardiogram and 6MWT at baseline and annually thereafter.Results: In total, 799 patients were included within the study. Median baseline 6 min walk distance (6MWD) was 362 m (IQR: 231 m). 6MWD progressively decreased with worsening cardiac disease stage (458 m, 404 m, 331 m and 168 m for cardiac Mayo stages I, II, IIIa and IIIb, respectively (p<0.0001)). In patients with a baseline 6MWT of ≥350 m, the median overall survival was not reached (vs 30.0 (95% CI 23.2 to 36.8) months if <350 m and 5.0 (95% CI 2.8 to 7.2) months if unable to attempt 6MWT (p<0.0001). Following chemotherapy, only patients in a complete haematological response improved their 6MWD by 12 months (p=0.001). Improvement in 6MWD prolonged survival in patients with cardiac amyloidosis (p=0.005).Conclusion: The 6MWT is prognostic in AL amyloidosis. A baseline distance of ≥350 m independently predicts better survival. These data suggest that 6MWT has utility in AL amyloidosis for baseline prognosis and assessing response. [ABSTRACT FROM AUTHOR]

To assess the clinical resources available for the assessment of health outcomes in people with lower limb amputation and to understand barriers and facilitators associated with use of standardized outcome measures in clinical practice. Cross-sectional survey. General community (online). A volunteer sample of prosthetic practitioners was recruited through national professional organizations. Eligible participants were practitioners certified by a professional prosthetics organization and currently practicing as a prosthetist, prosthetist-orthotist, or prosthetic assistant. Not applicable. A custom-designed online survey on clinical use of patient-reported and performance-based standardized outcome measures to assess patients with lower limb amputation. A total of 375 participants completed the survey. Most participants (79%) reported that they are encouraged or required to administer standardized outcome measures in their clinic or facility. Most participants reported that use of patient-reported and performance-based outcome measures are within their scope of practice (88%) and that they have the knowledge required for outcomes measurement (84%). Few participants agreed that outcomes measurement is standardized across the profession (30%). Most participants had access to small spaces and equipment for outcomes measurement, such as short hallways (65%-94%), stairs (69%), and tablets with wireless internet connection (83%). Most participants reported that they would be willing to spend between 5 (36% of participants) and 10 (43% of participants) minutes on self-reported surveys, and between 10 (41% of participants) and 20 (28% of participants) minutes on performance-based tests. Outcomes measurement is encouraged or expected in contemporary prosthetic practice. Strategies to improve standardization and efficiency of administration are needed to facilitate routine use of outcome measures in clinical care. [ABSTRACT FROM AUTHOR]

Objectives: Inflammatory rheumatic and musculoskeletal diseases (iRMDs) are associated with increased systemic bone loss that is mediated by chronic inflammation, treatment with glucocorticoids (GCs) and other factors. Our objective was to analyse the impact of variables that influence osteoporosis (OP) in patients with iRMD treated with GC.Methods: Rh-GIOP (acronyme) is a prospective observational cohort study investigating bone health in consecutive patients with iRMD and current or prior GC treatment. We present an analysis of the patients' baseline data here. Bone mineral density (BMD) measured by dual X-ray absorptiometry was the primary outcome. Multivariable linear regression models were performed to identify variables associated with BMD.Results: Data from 1066 patients with iRMD were analysed. GC doses of <5 mg prednisone equivalent per day, cumulative dose and duration of GC therapy were not associated with negative effects on BMD. Dosages of ≥5 mg/day lost their negative association with BMD after adjustment for confounders. When subanalysing patients with exactly 5 mg/day, no negative effect was seen. For patients with rheumatoid arthritis (RA), GC doses of >7.5 mg/day showed a negative association with BMD overall, but this effect seemed to be specific only to patients with moderate or high disease activity (Disease Activity Score 28-C reactive protein >3.2).Conclusions: GCs of ≤5 mg/day did not seem to be associated with a reduction of BMD in patients with iRMD and current or prior exposure to GC. This is most likely due to the dampening of inflammation by GC, which exerts a mitigating effect on the risk of OP. In RA, current GC doses of >7.5 mg/day were negatively associated with BMD, but only in patients with moderate to high disease activity.Trial Registration Number: NCT02719314. [ABSTRACT FROM AUTHOR]

Objective: The advantage of beta-blockers has been postulated in patients with Takotsubo syndrome (TTS) given the pathophysiological role of catecholamines. We hypothesised that beta-blocker treatment after discharge may improve the long-term clinical outcome in this patient population.Methods: This was an observational, multicentre study including consecutive patients with TTS diagnosis prospectively enrolled in the Takotsubo Italian Network (TIN) register from January 2007 to December 2018. TTS was diagnosed according to the TIN, Heart Failure Association and InterTAK Diagnostic Criteria. The primary study outcome was the occurrence of all-cause death at the longest available follow-up; secondary outcomes were TTS recurrence, cardiac and non-cardiac death.Results: The study population included 825 patients (median age: 72.0 (63.0-78.0) years; 91.9 % female): 488 (59.2%) were discharged on beta-blockers and 337 (40.8%) without beta-blockers. The median follow-up was 24.0 months. The adjusted Cox regression analysis showed a significantly lower risk for all-cause death (adjusted HR: 0.563; 95% CI: 0.356 to 0.889) and non-cardiac death (adjusted HR: 0.525; 95% CI: 0.309 to 0.893) in patients receiving versus those not receiving beta-blockers, but no significant differences in terms of TTS recurrence (adjusted HR: 0.607; 95% CI: 0.311 to 1.187) and cardiac death (adjusted HR: 0.699; 95% CI: 0.284 to 1.722). The positive survival effect of beta-blockers was higher in patients with hypertension than in those without (pinteraction=0.014), and in patients who developed cardiogenic shock during the acute phase than in those who did not (pinteraction=0.047).Conclusions: In this real-world register population, beta-blockers were associated with a significantly higher long-term survival, particularly in patients with hypertension and in those who developed cardiogenic shock during the acute phase. [ABSTRACT FROM AUTHOR]

Introduction: A curative-intent surgical procedure, pleurectomy/decortication, for malignant pleural mesothelioma is accompanied by a high incidence of major postoperative complications. Although epidural block, which suppresses nociception during and after surgery, reportedly has both benefits and disadvantages in terms of outcomes after thoracic surgery for other diseases, the effects of epidural block on major complications after pleurectomy/decortication have not been evaluated. The aim of this study was to evaluate the association between epidural block and major postoperative complications following pleurectomy/decortication.Methods: In a single-institutional observational study, consecutive adult patients undergoing pleurectomy/decortication under general anesthesia were enrolled from March 2019 to December 2021. Multivariable logistic regression analysis was performed to determine the association between perioperative variables and major complications. Next, patients were divided into two groups: general anesthesia with and without epidural block. Incidences of major postoperative complications, defined as Clavien-Dindo grades≥III, were compared between groups.Results: In all patients enrolled with American Society of Anesthesiologists (ASA) physical status II or III (n=99), general anesthesia without epidural block was identified as a sole risk factor for major complications among perioperative variables. The incidence of major complications was 32.3% (95% CI 19.1% to 49.2%) in patients with epidural block (n=34), which was significantly lower than 63.1% (95% CI 50.9% to 73.8%) in patients without epidural block (n=65). In sensitivity analysis in patients with ASA physical status II alone, the same results were obtained.Conclusion: Epidural block is likely associated with reduction of the incidence of major complications after pleurectomy/decortication for malignant pleural mesothelioma under general anesthesia. [ABSTRACT FROM AUTHOR]

Background and Objectives: Administrative data are invaluable for assessing outcomes at the population level. However, there are few validated patient-centered outcome measures that capture morbidity following traumatic brain injury (TBI) using these data. We sought to characterize and validate days at home (DAH) as a measure to quantify population-level outcomes after moderate to severe TBI. We additionally assessed the earliest feasible outcome assessment period for patients with TBI using this outcome measure., Methods: This multicenter retrospective cohort study used linked health administrative data sources to identify adults with moderate to severe TBI presenting to trauma centers in Ontario, Canada, between 2009 and 2021. DAH at 180 days (DAH 180 days ) reflects the total number of days spent alive and at home excluding the days spent institutionalized across care settings. Construct validity was determined using hierarchical quantile regression to assess the associations between clinical and injury covariates with DAH 180 days . Predictive validity was assessed using Spearman rank correlation. We estimated minimally important difference (MID) in DAH 180 days to aid with outcome measure interpretability., Results: There were 6,340 patients who met inclusion criteria. Median DAH 180 days was 70 days (interquartile range 0-144). Mortality occurred in 2,162 (34.1%) patients within 90 days following injury. Patients in the lower DAH 180 days group were more commonly older (absolute standardized difference [ASD] = 0.68) with higher preinjury health resource utilization (ASD = 0.36) and greater injury severity (ASD = 0.81). Increased baseline health resource utilization (-10.1 days, 95% CI -17.4 to -2.8, p = 0.0041), older age (-4.6 days, 95% CI -5.7 to -3.4, p < 0.001), higher cranial injury severity (-84.6 days, 95% CI -98.3 to -71.0, p < 0.001), and major extracranial injuries (-14.2 days, 95% CI -19.5 to -8.93, p < 0.001) were significantly associated with fewer DAH 180 days . DAH 180 days was positively correlated with DAH at up to 3 years ( r = 0.91, 95% CI 0.90-0.92) and negatively correlated with direct health care expenditure ( r s = -0.89, 95% CI -0.88 to -0.90). The average MID estimated from anchor-based and distribution-based methods was 18 days., Discussion: We validate DAH 180 days as a potentially useful outcome measure with construct, predictive, and face validity in a population with moderate to severe TBI. Given the intensity of acute care requirements for patients with TBI, our work highlights DAH 180 days as a feasible and sufficiently responsive outcome measure.

Objective: Most patients who have an implantable cardioverter-defibrillator (ICD) implant do not receive life-prolonging therapy from it. Little research has been undertaken to determine which patients benefit the least from ICD therapy. As patients age and accumulate comorbidities, the risk of death increases and the benefit of ICDs diminishes. We sought to evaluate the impact of comorbidity, frailty, functional status on death with no prior appropriate ICD therapy., Methods: A prospective, multicentre, observational study involving 12 English hospitals was undertaken. Patients were eligible for inclusion for the study if they were scheduled to have a de novo, upgrade to or replacement of a transvenous or subcutaneous ICD or cardiac resynchronisation therapy device and defibrillator (CRT-D). Baseline characteristics were collected. Participants were asked to complete a frailty assessment (Fried score) and a functional status questionnaire (EuroQol 5-Dimension 5-Level (EQ-5D-5L)). The Charlson Comorbidity Index was calculated. Patients were prospectively followed up for 2.5 years. The primary outcome was death with no prior appropriate therapy., Results: In total, 675 patients were enrolled, mean age 65.7 (IQR 65-75) years. A total of 63 patients (9.5%) died during follow-up, 58 without receiving appropriate ICD therapy. Frailty was present in 86/675 (12.7%) and severe comorbidity in 69/675 (10.2%). Multivariate predictors of death with no appropriate therapy were identified and a risk score comprising frailty, comorbidity, increasing age, estimated glomerular filtration rate and EQ-5D-5L was developed., Conclusion: Comorbidities, frailty and the EQ-5D-5L score are powerful, independent predictors of death with no prior appropriate therapy in ICD/CRT-D recipients., Competing Interests: Competing interests: This study has benefitted from funding from an Research Grant from Boston Scientific to complete the data analysis and write of this study. JMM, the senior author, is currently an employee of Boston Scientific. He was not an employee of Boston Scientific at the time that the study was conceived and initiated., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: To determine whether granulocyte colony-stimulating factor (G-CSF) improves clinical outcomes after large ST-elevation myocardial infarction (STEMI) when administered early in patients with left ventricular (LV) dysfunction after successful percutaneous coronary intervention (PCI)., Methods: STEM-AMI OUTCOME was designed as a prospective, multicentre, nationwide, randomised, open-label, phase III trial (ClinicalTrials.gov ID: NCT01969890) to demonstrate the efficacy and safety of early G-CSF administration in reducing 2-year cardiac mortality and morbidity in patients with STEMI with LV ejection fraction ≤45% after PCI. The primary outcome was a composite of all-cause death, recurrence of myocardial infarction and hospitalisation for heart failure. Due to low recruitment and event rates, the study was discontinued and did not achieve adequate statistical power to verify the hypothesis., Results: Patients were randomly allocated to G-CSF (n=260) or standard of care (SOC; n=261). No difference was found in the composite primary outcome between study groups (HR 1.20; 95% CI 0.63 to 2.28). The 2-year mortality was 2.31% in the G-CSF and 2.68% in the control group (HR 0.88; 95% CI 0.29 to 2.60). Adverse events did not differ between the G-CSF (n=65) and SOC groups (n=58; OR 1.17; 95% CI 0.78 to 1.75). In post hoc analyses on the intervention group, we observed a trend towards fewer composite primary outcomes in patients with low bone marrow (BM) cell mobilisation (n=108) versus those with high mobilisation (n=152, with peak leucocyte count >50×10 9 /L; HR 2.86; 95% CI 0.96 to 8.56). Primary outcomes were lower in patients with severe LV systolic dysfunction at discharge treated with G-CSF than in controls (interaction β±SE, -0.08±0.04; p=0.034)., Conclusions: Although inconclusive, this is the largest trial in the field of cell-based cardiac repair after STEMI providing evidence of the tolerability and long-term safety of G-CSF treatment. The results prompt further studies to understand which patient can benefit most from BM cell mobilisation., Trial Registration Number: NCT01969890., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Several adversity-focused treatment trials have reported improvements to adversity sequelae (e.g., PTSD symptoms) and decreases in psychotic symptoms among individuals with psychotic disorders. Yet, no trials have examined the impact of adversity-focused treatment on substance use or examined the outcomes among an early phase psychosis population. These gaps in both the research literature and clinical practice have resulted in less knowledge about the outcomes of adversity-focused treatment at this stage of illness, including the impact on substance use., Methods: The outcomes of an adapted prolonged exposure protocol (PE+) among an early phase psychosis population were examined using a multiple-baseline design. Nineteen adults with a psychotic disorder, current substance misuse, and a history of adversity were recruited from an early psychosis program. Participants were randomized to treatment start time and participated in a 15-session course of PE + therapy. Ten assessments were completed focusing on primary outcomes (i.e., adversity sequelae, negative psychotic symptoms, substance misuse) and secondary outcomes (i.e., functioning, hopelessness, experiential avoidance). The Reliable Change Index (RCI) was used to establish whether there were clinically significant changes to primary or secondary outcomes., Results: Half or more of treatment completers experienced clinically significant changes to most domains of adversity sequelae, no participants experienced improvements in negative psychotic symptoms, and substance misuse increased for several participants. In terms of secondary outcomes, functioning and experiential avoidance were improved for a number of participants, while hopelessness decreased for only one participant. Participants reported high satisfaction with the PE + treatment, and exposure and coping skills were rated as the most helpful elements of treatment., Conclusions: Reductions in adversity sequelae were observed following PE + treatment, suggesting that adversity-focused treatment may be beneficial for an early psychosis population. Yet, few positive changes to psychotic symptoms or substance use were observed. Further integrating treatment strategies for psychosis and substance use into PE + may be required to effectively treat the links between psychosis, adversity sequelae, and substance use. Future studies should make efforts to integrate substance use strategies into adversity treatment trials for people with psychotic disorders., Trial Registration: Clinicaltrials.gov, NCT04546178; registration posted 11/09/2020, https://clinicaltrials.gov/ct2/show/NCT04546178?term=NCT04546178&draw=2&rank=1 ., (© 2024. The Author(s).)

Background: Outcome measures are crucial to support a treat-to-target approach to rheumatoid arthritis (RA) care, yet their integration into clinical practice remains inconsistent. We developed an Electronic Heath Record-integrated, patient-facing side-car application to display RA outcomes (disease activity, functional status, pain scores), medications, and lab results during clinical visits ("RA PRO Dashboard"). The study aimed to evaluate patient perceptions and attitudes towards the implementation of a novel patient-facing dashboard during clinical visits using a mixed-methods approach., Methods: RA patients whose clinicians used the dashboard at least once during their clinical visit were invited to complete a survey regarding its usefulness in care. We also conducted semi-structured interviews with a subset of patients to assess their perceptions of the dashboard. The interviews were transcribed verbatim and analyzed thematically using deductive and inductive techniques. Emerging themes and subthemes were organized into four domains of the Ecological Model of Health., Results: Out of 173 survey respondents, 79% were interested in seeing the dashboard again at a future visit, 71% felt it improved their understanding of their disease, and 65% believed it helped with decision-making about their RA care. Many patients reported that the dashboard helped them discuss their RA symptoms (76%) and medications (72%) with their clinician. Interviews with 29 RA patients revealed 10 key themes: the dashboard was perceived as a valuable visual tool that improved patients' understanding of RA outcome measures, enhanced their involvement in care, and increased their trust in clinicians and the clinic. Common reported limitations included concerns about reliability of RA outcome questionnaires for some RA patients and inconsistent collection and explanation of these measures by clinicians., Conclusions: In both the quantitative and qualitative components of the study, patients reported that the dashboard improved their understanding of their RA, enhanced patient-clinician communication, supported shared decision-making, and increased patient engagement in care. These findings support the use of dashboards or similar data visualization tools in RA care and can be used in future interventions to address challenges in data collection and patient education., (© 2024. The Author(s).)

This systematic review provides a structured overview of the measurement instruments of functional outcome used in lower extremity and pelvic bone sarcoma patients. We identified 42 unique instruments covering 18 distinct functional outcome constructs with most studies measuring constructs within the activity domain of the International Classification of Functioning, disability, and health. The MusculoSkeletal Tumor Society 1993 and 1987 score, Toronto Extremity Salvage Score, and range of motion instruments were the measurement instruments most commonly used., (© 2024 Wiley Periodicals LLC.)

Background/aims: The measurement of implementation outcomes can establish the success of implementing evidence into practice. However, implementation outcomes are seldom measured in acute healthcare settings, such as Paediatric Intensive Care Units (PICU), and if they are used, are likely to be non-validated, site or intervention-specific measures. To address this literature gap, this systematic review of systematic reviews aims to identify validated instruments to measure implementation outcomes of new EBP interventions in a PICU setting., Methods: A systematic review of systematic reviews was conducted in two phases. Phase One: Five electronic databases were searched between 06/10/22 and 14/10/22. Systematic reviews were selected using pre-determined eligibility criteria. Methodological quality was assessed using the Critical Appraisal Skills Programme tool and a data extraction table was used to allow further synthesis. Phase Two: Secondary eligibility criteria were used to extract and review instruments from the systematic reviews selected in Phase One. Instruments were analysed and mapped to the Consolidated Framework of Implementation Research (CFIR)., Results: Phase One: Searches resulted in 3195 unique papers. Five systematic reviews were eligible for inclusion. All examined the psychometric properties of each instrument, utilising different methods to do so; three considered their pragmatic or usability properties; and one identified instruments that were transferrable to different settings. Each systematic review identified that most included instruments had limited evidence of their validity or reliability and had poor psychometric properties. Phase two: 93 instruments were screened, and nine were eligible for analysis. After analysis and CFIR mapping, two instruments were identified as potentially adaptable to the PICU setting., Conclusions: The methodological quality of implementation outcome measurement instruments is inadequate, warranting further validation research. Two instruments were identified that cover multiple CFIR domains and have scope to be adapted for use when implementing evidence-based practice into the PICU. Further work is needed to adapt and further validate an instrument for use in practice., Trial Registration: For transparency of procedures and methods, the protocol for this systematic review was registered with PROSPERO (registration number CRD42022361638L)., (© 2024. The Author(s).)