Outcome Information Research Articles

The Importance of Quality of Home Health Agencies for Patients in Socioeconomically Disadvantaged Neighborhoods

ObjectivesThis study investigated the role of patients' neighborhood socioeconomic status (SES) on the relationship between home health agency (HHA) care quality and health outcomes among home health care patients. DesignRetrospective cohort study. Setting and ParticipantsWe mainly used 2019 Outcome and Assessment Information Set data, Area Deprivation Index, and Quality of Patient Care Star Rating. We included Medicare beneficiaries (≥ 65 years of age) who received home health care. MethodsWe used linear probability regression models to examine whether patients' neighborhood SES moderates the association between care quality of HHAs and health outcomes for 1,657,133 home health care patients. ResultsOur findings show that patients in neighborhoods with lower SES were more likely to use low-quality HHAs (lease disadvantaged neighborhoods: 11%, most disadvantaged neighborhoods: 15.2%). Our main model, adjusted by patient- and HHA-level characteristics, reveals patients living in socioeconomically disadvantaged neighborhoods (less disadvantaged: coefficient: −0.017, P < .001; more disadvantaged: coefficient: −0.035, P < .001; most disadvantaged: coefficient: −0.06, P < .001) and receiving care from low-quality HHAs (average-quality HHAs: coefficient: 0.037, P < .001; high-quality HHAs: coefficient: 0.062, P < .001) were less likely to remain in the community during their home health care. Furthermore, our study highlights that patients in the most disadvantaged neighborhoods encounter additional challenges in remaining at their homes and communities when they use low-quality HHAs. Conclusions and ImplicationsThese findings highlight the need for targeted interventions and policy initiatives aimed at addressing disparities in care quality based on neighborhood SES. Efforts directed at enhancing the quality of care provided by HHAs and access to high-quality HHAs in socioeconomically disadvantaged neighborhoods could substantially impact health equity and outcomes for individuals in these settings.

Nuclear pleomorphism in canine cutaneous mast cell tumors: Comparison of reproducibility and prognostic relevance between estimates, manual morphometry, and algorithmic morphometry.

Variation in nuclear size and shape is an important criterion of malignancy for many tumor types; however, categorical estimates by pathologists have poor reproducibility. Measurements of nuclear characteristics can improve reproducibility, but current manual methods are time-consuming. The aim of this study was to explore the limitations of estimates and develop alternative morphometric solutions for canine cutaneous mast cell tumors (ccMCTs). We assessed the following nuclear evaluation methods for accuracy, reproducibility, and prognostic utility: (1) anisokaryosis estimates by 11 pathologists; (2) gold standard manual morphometry of at least 100 nuclei; (3) practicable manual morphometry with stratified sampling of 12 nuclei by 9 pathologists; and (4) automated morphometry using deep learning-based segmentation. The study included 96 ccMCTs with available outcome information. Inter-rater reproducibility of anisokaryosis estimates was low (k = 0.226), whereas it was good (intraclass correlation = 0.654) for practicable morphometry of the standard deviation (SD) of nuclear size. As compared with gold standard manual morphometry (area under the ROC curve [AUC] = 0.839, 95% confidence interval [CI] = 0.701-0.977), the prognostic value (tumor-specific survival) of SDs of nuclear area for practicable manual morphometry and automated morphometry were high with an AUC of 0.868 (95% CI = 0.737-0.991) and 0.943 (95% CI = 0.889-0.996), respectively. This study supports the use of manual morphometry with stratified sampling of 12 nuclei and algorithmic morphometry to overcome the poor reproducibility of estimates. Further studies are needed to validate our findings, determine inter-algorithmic reproducibility and algorithmic robustness, and explore tumor heterogeneity of nuclear features in entire tumor sections.

Abstract 4129036: Air pollution and Cardiovascular Disease Incidence in a Pooled Analysis of 6 U.S. Cohorts

Introduction/Background: Long term air pollution is associated with cardiovascular disease (CVD) incidence, however the effects at low levels in the US are unknown. Research Questions/Hypothesis: To assess the effect of long-term exposure to ambient air pollution CVD incidence (myocardial infarction [MI], stroke, and all CVD) in a pooled analysis of epidemiological cohorts. Materials and Methods: We harmonized data from six cohorts (Cardiovascular Health Study, Nurses’ Health Study II, Multi-Ethnic Study of Atherosclerosis, and Reasons for Geographic And Racial Differences in Stroke Study, Sister Study, and Women’s Health Initiative) with both CVD incidence data and extensive covariate information. We predicted time-varying two-year average concentrations of particulate matter &lt;2.5 microns (PM 2.5 ) and nitrogen dioxide (NO 2 ) from 1990-2019 at participant residential addresses using validated regionalized spatio-temporal models, combining spatio-temporal universal kriging and partial least squares regression with inputs from monitoring data from regulatory and researcher-deployed networks, satellite remote-sensing data and chemical transport modeling. Cox proportional hazards regression models adjusted for individual and area-level information, including smoking status, socio-economic factors, anthropometry, blood pressure, cholesterol, and other clinical variables. Results: Our analysis included over 300,000 participants and 10,229 incident CVD events. The median residential concentration of PM 2.5 was 10.1 µg/m 3 and NO 2 was 9.3 ppb. A 5 µg/m 3 increase in PM 2.5 was not significantly associated with a higher hazard ratio for all outcomes: 1.03 (95%CI: 0.96, 1.10) for CVD incidence, 1.03 (95%CI 0.93, 1.15) for MI, and 1.00 (95%CI 0.90, 1.10) for stroke. We found that a 10ppb increase in NO 2 was associated with a 1.06 (95%CI: 1.01, 1.11) higher hazard ratio for CVD, 1.07 (95%CI: 1.01, 1.11) for MI, and 1.02 (95%CI 0.96, 1.09) for stroke. Conclusions: In this analysis of a large, pooled cohort with excellent exposure, outcome, and covariate information, we found an association of NO 2 exposure—considered a surrogate for traffic-related air pollution—with CVD incidence and MI. Associations with particulate matter were not statistically significant, but could not exclude a small increased risk. We are extending this analysis to include 6 additional cohorts and an additional 700,000 participants to allow for generation of a highly resolved concentration-response function.

BIOS-03. CLINICAL PRESENTATION, MANAGEMENT, AND OUTCOME IN NEUROLYMPHOMATOSIS: A SYSTEMATIC REVIEW AND ANALYSIS OF INDIVIDUAL PATIENT DATA FROM 459 CASES

Abstract BACKGROUND Neurolymphomatosis (NL) refers to lymphomatous infiltration of the peripheral nervous system (PNS). NL diagnosis and treatment are challenging given the broad differential diagnosis of peripheral neuropathy, the lack of larger cohorts and the subsequent unavailability of prognostic factors or consensus therapy. This study aimed to define characteristics and prognostic factors of NL. METHODS A systematic review of the literature (2004-2023) was performed using PubMed and Scopus databases and reported following PRISMA guidelines. Clinical, radiological, pathological and outcome information were extracted. Multivariable survival analyses were performed using Cox proportional hazard models. RESULTS A total of 459 NL cases from 264 studies were accumulated. NL was the first manifestation of malignancy (primary NL) in 197 patients. PNS relapse of known non-Hodgkin lymphoma (secondary NL) occurred in 262 cases after a median 12 months. NL predominantly presented with rapidly deteriorating, asymmetric painful polyneuropathy. Infiltrated structures included peripheral nerves (56%), nerve roots (52%), plexus (33%) and cranial nerves (32%). Diagnosis was established at a median of 3 months after symptom onset with substantial delays in primary NL. It mainly relied on PNS biopsy or FDG-PET, which carried high diagnostic yields (&amp;gt; 90%). Post mortem diagnoses were rare (3%). Most cases were classified as B-cell (90%) lymphomas. Tumor-directed therapy was administered in 96% of patients and typically consisted of methotrexate or rituximab-based polychemotherapy. Median overall survival was 18 months. Primary NL without concurrent systemic disease outside the nervous system (hazard ratio [HR]: 0.44; 95% confidence interval (CI): 0.25-0.78; p = 0.005), performance status (ECOG &amp;lt; 2, HR: 0.30; 95% CI: 0.18-0.52; p &amp;lt; 0.0001), and rituximab-based treatment (HR: 0.46; 95% CI: 0.28-0.73; p = 0.001) were identified as favorable prognostic markers on multivariable analysis when adjusting for clinical and sociodemographic parameters. CONCLUSIONS Advances in neuroimaging modalities, particularly FDG-PET, facilitate NL diagnosis and offer a high diagnostic yield. Rituximab-based therapy improves NL outcome. Findings may assist clinicians in early recognition, prognostic stratification, and treatment of NL.

The Efficacy of Calcium Sulfate/Hydroxyapatite (CaS/HA) Gentamicin in Osteomyelitis Treatment: A Case Series.

Osteomyelitis is a challenging condition caused by infection and inflammation of the bone, presenting a significant economic burden to healthcare systems. Calcium sulfate/hydroxyapatite (CaS/HA) is a bone void filler composed of 60% calcium sulfate and 40% hydroxyapatite. This case series aimed to report the efficacy and infection-related outcomes of CaS/HA combined with Gentamicin (CaS/HA-G) in treating osteomyelitis. Patients aged 18 and older diagnosed with osteomyelitis requiring surgical intervention and treated with CaS/HA-G during their procedure were included in the study, with a median (Q1-Q3) = 10 (7-16)-month follow-up period of time. Data collected included demographic, surgical, and outcome information. Infection eradication was determined by the normalization of the C-reactive protein, erythrocyte sedimentation rate levels, or the absence of clinical infection symptoms. The case series involved 21 patients (twelve male, nine female) with a mean (SD) age of 54.8 (16.6) years. Vancomycin or/and Tobramycin were used as an additional antibiotic in 17 patients. At the last follow-up, 20 out of 21 patients (95.2%) had eradicated the infection, with a median (Q1-Q3) eradication time of 128 (71.8-233.5) days. In conclusion, this study demonstrates that CaS/HA-G is effective in controlling osseous infection in osteomyelitis while acting as an absorbable bone void filler.

Developing a clinical decision support framework for integrating predictive models into routine nursing practices in home health care for patients with heart failure.

The healthcare industry increasingly values high-quality and personalized care. Patients with heart failure (HF) receiving home health care (HHC) often experience hospitalizations due to worsening symptoms and comorbidities. Therefore, close symptom monitoring and timely intervention based on risk prediction could help HHC clinicians prevent emergency department (ED) visits and hospitalizations. This study aims to (1) describe important variables associated with a higher risk of ED visits and hospitalizations in HF patients receiving HHC; (2) map data requirements of a clinical decision support (CDS) tool to the exchangeable data standard for integrating a CDS tool into the care of patients with HF; (3) outline a pipeline for developing a real-time artificial intelligence (AI)-based CDS tool. We used patient data from a large HHC organization in the Northeastern US to determine the factors that can predict ED visits and hospitalizations among patients with HF in HHC (9362 patients in 12,223 care episodes). We examined vital signs, HHC visit details (e.g., the purpose of the visit), and clinical note-derived variables. The study identified critical factors that can predict ED visits and hospitalizations and used these findings to suggest a practical CDS tool for nurses. The tool's proposed design includes a system that can analyze data quickly to offer timely advice to healthcare clinicians. Our research showed that the length of time since a patient was admitted to HHC and how recently they have shown symptoms of HF were significant factors predicting an adverse event. Additionally, we found this information from the last few HHC visits before the occurrence of an ED visit or hospitalization were particularly important in the prediction. One hundred percent of clinical demographic profiles from the Outcome and Assessment Information Set variables were mapped to the exchangeable data standard, while natural language processing-driven variables couldn't be mapped due to their nature, as they are generated from unstructured data. The suggested CDS tool alerts nurses about newly emerging or rising risks, helping them make informed decisions. This study discusses the creation of a time-series risk prediction model and its potential CDS applications within HHC, aiming to enhance patient outcomes, streamline resource utilization, and improve the quality of care for individuals with HF. This study provides a detailed plan for a CDS tool that uses the latest AI technology designed to aid nurses in their day-to-day HHC service. Our proposed CDS tool includes an alert system that serves as a guard rail to prevent ED visits and hospitalizations. This tool can potentially improve how nurses make decisions and improve patient outcomes by providing early warnings about ED visits and hospitalizations.

Longitudinal validation of the PROMIS-16 in a sample of adults in the United States with back pain.

This longitudinal study evaluates whether the Patient-Reported Outcomes Measurement and Information System (PROMIS)-16 domains capture average change over time comparable to the PROMIS-29 + 2 and have similar associations with change in overall health rating and two disability indices. Data were collected using Amazon's Mechanical Turk at baseline, 3 months, and 6 months among individuals reporting chronic low back pain. The analytic sample includes respondents who completed baseline and at least one follow-up assessment (N = 1137). We estimated latent growth models for eight PROMIS domains and compared growth parameters between the PROMIS-16 and PROMIS 29 + 2 with a z-test. Additionally, for each domain, random intercept and slope scores for individuals were computed for the PROMIS-29 + 2 and PROMIS-16 and correlated to estimate concordance. Using growth parameters for physical function and pain interference, we predicted average change in the Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMDQ), the overall health rating, and compared regression coefficients between the PROMIS-16 and PROMIS 29 + 2. All growth models fit the data well. Intercept and slope parameters were statistically comparable (p's > 0.05) in magnitude across all domains between the PROMIS-16 and PROMIS-29 + 2. Correlations between random intercept and slope scores for individuals across domains were high. Additionally, the regression coefficients between slopes for pain interference and physical function and ODI, RMDQ, and overall health rating were statistically comparable (p's > 0.05) between the PROMIS-16 and PROMIS 29 + 2. Results provide between-level support for the longitudinal and predictive validity of the PROMIS-16. Similar average baseline scores and changes over time were observed between PROMIS-16 and PROMIS-29 + 2. Further, average change estimates comparably predicted average change in distal outcomes. This work provides evidence supporting the utility of the PROMIS-16 as a viable, short-profile option for use in clinical and research settings.

Definition and understanding of "efficiency" in healthcare provision research: a scoping review.

With rising healthcare costs over the last decades, the concept of efficiency has gained popularity in healthcare provision research. As efficiency can be understood and measured in many different ways, it is often unclear what is meant by "efficient health systems" or "efficient healthcare providers". This study aims to analyze and categorize the different definitions and understandings of "efficiency" used in healthcare provision research over time. We searched five databases (Medline, Embase, CINAHL, Business Source Premier, and EconLit) to conduct a scoping review. Sources were screened independently by two researchers, using the online software Rayyan. Results are reported using PRISMA-ScR. Of 1,441 individual sources identified, 389 were included in the review. Most papers (77.3%) using the term "efficiency" do not include explicit definitions or explanations of their understanding of it. Almost all papers (99.0%) are interested in productive efficiency (vs. allocative efficiency) and more specifically technical efficiency, therefore comparing the number of inputs used and outputs produced. While many papers (70.4%) include some elements of quality of care or health outcomes in their discussion, few (30.3%) include aspects of quality in their measurement of efficiency. Over the last decades, Data Envelopment Analysis has become the main method to measure efficiency. We propose a broad categorization of efficiency definitions that could be used by researchers to improve the comprehensibility and comparability of their research. Key features are the general type of efficiency, inclusion of quality or outcome information, and inclusion of cost information. To allow for better comparability and comprehensibility, researchers in healthcare provision should state explicitly which type of efficiency they are studying. To do this, we propose to use combinations of the terms productive efficiency, allocative efficiency, quality-inclusive efficiency, and cost efficiency.

A retrospective cohort study on the protective effect of influenza vaccination during pregnancy in Gansu Province

ABSTRACT To evaluate the Vaccine Effectiveness (VE) of the Influenza Vaccine (InfV) during pregnancy in Gansu province. A retrospective cohort of pregnant women vaccinated with InfV was constructed using the electronic case system and immunization planning system of Gansu province. Outcome information of Influenza-Like Illness (ILI) in pregnant women after vaccination with InfV during the influenza epidemic seasons from 2019 to 2021 was collected. The log-binomial model was used to estimate the adjusted Risk Ratio (RR), VE, and their Confidence Intervals (CI). The incidence rates of the InfV vaccination group and the non-vaccination group during pregnancy in Gansu province were 4.70% (54/1,150) and 6.91% (16,990/245,754), respectively. The adjusted RR was 0.78 (95%CI 0.43–0.75), and the adjusted VE was 22.20 (95%CI 0.79–40.30). Vaccination with InfV during pregnancy in Gansu province from 2019 to 2021 has a protective effect against ILI in pregnant women, and there is no difference in vaccination at different stages of pregnancy.

Efficacy of Chimeric Antigen Receptor Engineered Natural Killer Cells in the Treatment of Hematologic Malignancies: A Systematic Review and Meta-Analysis of Preclinical Studies

BackgroundChimeric antigen receptor (CAR) engineered NK cells (CAR-NK) are a novel approach to the immunotherapy of hematologic malignancies which seeks to overcome some of the challenges faced by CAR-T cells (CAR-T). With few published clinical studies, preclinical studies can identify strategies to accelerate clinical translation. We conducted a systematic review on the preclinical in vivo use of CAR-NK for the treatment of hematologic malignancies to assess these therapies in a holistic and unbiased manner. MethodsOur protocol was registered with PROSPERO (ID: CRD42023438375). We performed a search of OVID MEDLINE, OVID Embase, and Embase for animal studies employing human CAR-NK cells in the treatment of hematologic malignancies. Screening of studies for eligibility criteria was performed in duplicate. Our primary outcomes were survival and reduction in tumor volume. Data extraction from individual experiments was performed by one reviewer using DigitizeitTM software and verified by a second reviewer. Meta-analysis and subgroup analyses were performed using Comprehensive Meta-AnalysisTM software. Information for descriptive outcomes was extracted in duplicate by two independent reviewers. Risk of bias was assessed using the SYRCLE Risk of Bias Tool for Animal Studies. ResultsA total of 34 papers met eligibility criteria. Overall, CD19 was the most common antigen targeted however there was substantial diversity in antigenic targets, source material for generating CAR-NK cells, and NK cell modifications. Mice treated with CAR-NK therapy survived significantly longer than untreated mice (median survival ratio of 1.18, 95% CI 1.10 – 1.27, p<0.001), and mice treated with non-engineered NK cells (median survival ratio 1.13, 95% CI, 1.03-1.23, p<0.001). Similarly, treatment with CAR-NK significantly reduced the tumor burden when compared to untreated mice (ratio of mean tumor volume 0.23, 95% CI 0.17 – 0.32, p<0.001) or mice treated with non-engineered NK cells (ratio of mean tumor volume 0.37, 95% CI 0.28-0.51, p<0.001). Subgroup analysis showed that co-treatment with IL-15 reduced tumor volume but did not increase survival. In general, CAR-NK cell persistence was short but was increased by IL-15. ConclusionsCAR-NK shows promise for the treatment of hematologic malignancies in preclinical models.

Change of Ownership and Quality of Home Health Agency Care

The home health agency (HHA) market has seen increasingly more change in ownership transactions. Little is known about the organizational characteristics and quality of care of HHAs after ownership has changed. To examine whether an HHA change in ownership was associated with different quality-of-care outcomes, patient volume, and staffing levels. Using current HHA change of ownership files linked to publicly available Medicare HHA data, this staggered difference-in-differences analysis evaluated ownership change transactions of Medicare-certified HHAs from quarter 1 of 2016 to quarter 4 of 2019. Pretransaction and posttransaction HHA characteristics and quality-of-care outcomes were compared between HHAs that changed ownership and up to 8 matched controls. The transactions in the main analysis included (1) when an HHA remained as for-profit with a change in ownership and (2) when an HHA changed from nonprofit/public to for-profit ownership. The data were analyzed between November 2023 and September 2024. The primary outcomes were HHA-quarter measures of star ratings, the individual quality measures that compose the star ratings based on the Outcome and Assessment Information Set, and claims-based quality metrics, such as hospitalizations and emergency department visits. The secondary outcomes included HHA year measures of Medicare patient volume, per capita payments, and staffing levels (full-time equivalents and minutes per visit). The main dataset included 294 Medicare-certified HHAs that changed ownership, matched with 2330 controls. In 3 years after an ownership change, quarterly star ratings increased by 0.18 (95% CI, 0.05-0.31) relative to matched controls, with greater increases among HHAs that converted from nonprofit/public to for-profit. No significant improvement was observed in the 60-day rates of hospital admissions or outpatient emergency department visits. Further, no significant changes were observed in the number of Medicare beneficiaries, but per capita payments increased within 2 years post-ownership change. Significant reductions were observed in full-time equivalents of registered nurses (-17% [95% CI, -31% to -3%]) and home health aides (-26% [95% CI, -39% to -13%]), as well as per-visit minutes for skilled nursing care (-5% [95% CI, -9% to -1%]), physical therapy (-3% [95% CI, -5% to 0%]), and home health aide care (-11% [95% CI, -15% to -6%]). In this difference-in-differences analysis of Medicare-certified HHAs, ownership change was associated with higher star ratings and Medicare per capita payments, but not with claims-based quality measures. Reduction in staffing levels after ownership change raises concerns about implications for quality of care.

Evaluating Repetitive Transcranial Magnetic Stimulation for Neuropsychiatric Symptoms in Long COVID: A Case Series.

To describe the immediate clinical outcomes of repetitive transcranial magnetic stimulation (rTMS) in treating long COVID symptoms. Long COVID currently impacts approximately 5.3% of US adults, presenting with persistent fatigue, depression, anxiety, cognitive impairments, and social function decline. Repetitive transcranial magnetic stimulation targeting the left dorsolateral prefrontal cortex has improved these symptoms in some studies. Five patients (ages 52-63 years, 3 female patients) underwent accelerated rTMS using intermittent theta burst stimulation (600 pulses over 3 minutes 20 seconds, 80%-120% of resting motor threshold) to the left dorsolateral prefrontal cortex. The treatment consisted of twice-daily sessions over 20-30 treatments. Outcomes were measured using the Patient-Reported Outcomes Measurement and Information System (PROMIS) questionnaires, assessing fatigue, depression, anxiety, cognitive function, and social function at baseline and immediately posttreatment. One patient discontinued immediately due to intolerable scalp pain. Posttreatment PROMIS scores showed the following: fatigue decreased from 74.5 to 61.8, depression from 60.3 to 51.5, and anxiety from 62.0 to 54.0. Scores increased for cognitive (26.8 to 32.3) and social (31.0 to 32.5) function. These changes, although not statistically significant, indicate a trend toward symptom reduction. Subjectively, 3 of 4 patients who completed the rTMS course reported improvements. This case series suggests that rTMS may offer symptomatic relief in long COVID patients. Although the observed improvements in PROMIS were not statistically significant, even minimal improvements are clinically significant for patients enduring prolonged suffering. These preliminary findings are encouraging and underscore the need for further research with larger cohorts to validate the efficacy of rTMS in long COVID symptom relief.

Perspectives of international experts and the Danish citizens on the ‘relevant knowledge’ that citizens need for making informed choices about participation in cancer screening: Qualitative study

ObjectivesThis study aimed to investigate the perspectives of international experts and Danish citizens on relevant knowledge about population-based breast, colorectal and cervical cancer screening. MethodsThis was a qualitative interview study with focus group interviews with experts and Danish citizens eligible for breast, colorectal and/or cervical cancer screening. Data were collected using semi-structured interview guides, audio-recorded and transcribed verbatim. A thematic analysis was conducted. ResultsParticipants were nine international experts from Germany, Canada, the USA, Sweden, the Netherlands and Australia, and 54 citizens from Denmark. Most citizens had 'adequate' or 'problematic' levels of health literacy. Themes that experts and citizens agreed on were: knowledge about the disease and symptoms, practical information about screening, benefits of screening, the option of non-participation and the importance of having numeric information of possible screening outcomes. Experts agreed on the importance of knowledge about the harms of screening, but only a minority of citizens considered this important. ConclusionsThe experts and citizens disagreed on the relevance of knowledge about harms of screening and agreed on other relevant knowledge. Practice implicationsWhat experts and citizens find important may not align when making informed decisions. Therefore, experts and citizens needs to be involved when developing questionnaires.

European Journal of Vascular and Endovascular Surgery Publication Standards for Reporting Vascular Surgical Research

Manuscripts submitted to the European Journal of Vascular and Endovascular Surgery (EJVES) often contain shortcomings in baseline scientific principles and incorrectly applied methodology. Consequently, the editorial team is forced to offer post hoc repair in an attempt to support the authors to improve their manuscripts. This repair could theoretically have been prevented by providing more clear definitions and reporting standards to serve researchers when planning studies and eventually writing their manuscripts. Therefore, here we summarise the general principles for EJVES reporting standards. These reporting standards did not follow a systematic approach but reflect the common opinion of the current senior and section editors team. This team decided to only include recommendations regarding the most common pathologies in vascular surgery in this first edition of reporting standards, namely carotid artery disease, abdominal aortic aneurysm (AAA), peripheral arterial occlusive disease (PAOD), and chronic venous disease. In future editions, we plan to expand the areas of research. We present (1) a common set of minimum but required reporting standards applicable to every report, e.g., patient characteristics, study design, treatment environment, selection criteria, core outcomes of interventions such as 30 day death and morbidity, and measures for completeness of data including outcome information, and (2) a common set of minimum reporting standards for four vascular areas. The editors of the EJVES propose universally accepted definitions and reporting standards for carotid artery disease, AAA, PAOD, and chronic venous disease. This will enable the development of a convincing body of evidence to aid future clinical practice guidelines and drive clinical practice in the right direction. These first ever publication and reporting standards for EJVES aim to improve future research in our journal.

What determines the overall quality of postoperative pain management? Aquestion of perspective

The outcome domains pain intensity, pain-related interference, side effects, (treatment) information, participation and personal interaction have all been identified as relevant factors in the management of perioperative pain. However, it is not yet clear which of these are particularly significant for the subjectively perceived overall quality of postoperative pain management. Anewly developed questionnaire was used in this cross-sectional study to assess the relevance of these domains for patients and compare the relevance to healthcare professionals (HCP). The patient survey (n = 40) was conducted on the first postoperative day at Jena University Hospital, Germany. In order to investigate group differences, 63 HCP (disciplines: n = 15 anaesthesiology, n = 17 surgery, n = 31 nursing) were recruited. The questionnaire primarily included all pairwise comparisons between the domains with regard to the overall quality of postoperative pain management. The resulting sum scores for each domain were the primary outcome measure, which were analysed using generalized estimating equations. Within the group of patients, there were significant differences in the prioritization of the six outcome domains, with personal interaction followed by intensity and interference having received the highest ratings. There were also significant differences within the domains between the perspectives of patients and HCP, as well as between the HCP themselves. The study demonstrates that personal interaction and the reduction of pain intensity and interference are three key factors that are significant for patients' experience of postoperative pain management. However, the extent to which the harmonisation of these three factors with those given prominence by HCP would positively impact postoperative pain management remains unclear and should be investigated further.

Group sequential testing of a treatment effect using a surrogate marker.

The identification of surrogate markers is motivated by their potential to make decisions sooner about a treatment effect. However, few methods have been developed to actually use a surrogate marker to test for a treatment effect in a future study. Most existing methods consider combining surrogate marker and primary outcome information to test for a treatment effect, rely on fully parametric methods where strict parametric assumptions are made about the relationship between the surrogate and the outcome, and/or assume the surrogate marker is measured at only a single time point. Recent work has proposed a nonparametric test for a treatment effect using only surrogate marker information measured at a single time point by borrowing information learned from a prior study where both the surrogate and primary outcome were measured. In this paper, we utilize this nonparametric test and propose group sequential procedures that allow for early stopping of treatment effect testing in a setting where the surrogate marker is measured repeatedly over time. We derive the properties of the correlated surrogate-based nonparametric test statistics at multiple time points and compute stopping boundaries that allow for early stopping for a significant treatment effect, or for futility. We examine the performance of our proposed test using a simulation study and illustrate the method using data from two distinct AIDS clinical trials.

'So Let's Go On Like This?'-Shared Decision-Making and the Use of Outcome Information in Routine Care Management for People With Multiple Sclerosis.

This study aimed to investigate how shared decision-making (SDM) and the use of different types of outcome information are applied in routine care management for people with multiple sclerosis (MS) in an academic outpatient clinic. This qualitative study used the following: (a) observations of clinical encounters (N = 23) between patients and healthcare professionals (HCPs), (b) interviews with those patients (N = 17)and (c) interviews with those HCPs (N = 7). HCPs were not trained in SDM before the study. Audio recordings were transcribed literally. Transcriptions were analysed using qualitative thematic analysis. Outcome information was hardly discussed with patients, apart from clinical outcome information at an individual level, such as MRI or lab results. This use of clinical outcome information did not automatically lead to a process of SDM. HCPs tended to implicitly present choices to patientsafter signalling and discussing 'problems'. In the interviews, patients indicated that they tended to consent to the advice given by HCPs and to prefer not too much change in treatment plans. However, they also emphasized the importance of being informed about available options with benefits and harms. We observed multiple discussions about patients'preferences, especially related to patients'experiences and priorities. Overall, SDM and the use of different types of outcome information did not seem to be enacted in routine care management for people with MS, mostly because choices werenot explicitly mentioned or discussed. However, discussions about patients'experiences and priorities did take place. Training HCPs further and developing patient information seem reasonable steps to proceed. People with MS contributed as research participantsand provided us with their experiences in interviews. Furthermore, representatives of two patient organizations contributed to the study by reviewing the interview protocol for people with MS.

Stroke Research Using Administrative Claims Database in Japan: A Narrative Review.

Although administrative claims databases have recently been used for clinical research in Japan, no detailed description of their utilization in stroke research is available. We reviewed stroke studies using the Diagnosis Procedure Combination (DPC), the National Database of Health Insurance Claims and Specific Health Checkups (NDB), and several commercial databases sourced from social health insurance associations, focusing on their applications and limitations. Original articles on stroke published by April 2024 using the DPC, NDB, and commercial databases were identified in Ovid MEDLINE. The characteristics of each database were compared in terms of comprehensiveness, traceability, baseline information, and outcome assessment in stroke research. A total of 114 studies were included (83 for DPC, 6 for NDB, and 25 for commercial databases). The number of stroke studies using administrative databases in Japan is still approximately 10 per year, although there is a slowly increasing trend. The DPC database was utilized for short-term outcome studies because of its detailed baseline and outcome information, although the inability to track patients once they changed facilities limits their use in long-term studies. The NDB database is potentially useful for long-term studies because of its comprehensiveness and traceability, but difficulties in data access restrict its usage. The most commonly used commercial database utilizes baseline information on lifestyle and blood test data, although the lack of coverage for those over 75 years old may limit its generalizability. Administrative claims databases are beginning to be used in stroke research in Japan but are not yet fully utilized. Researchers need to understand their applications and limitations.

Building Digital Twins for Cardiovascular Health: From Principles to Clinical Impact.

The past several decades have seen rapid advances in diagnosis and treatment of cardiovascular diseases and stroke, enabled by technological breakthroughs in imaging, genomics, and physiological monitoring, coupled with therapeutic interventions. We now face the challenge of how to (1) rapidly process large, complex multimodal and multiscale medical measurements; (2) map all available data streams to the trajectories of disease states over the patient's lifetime; and (3) apply this information for optimal clinical interventions and outcomes. Here we review new advances that may address these challenges using digital twin technology to fulfill the promise of personalized cardiovascular medical practice. Rooted in engineering mechanics and manufacturing, the digital twin is a virtual representation engineered to model and simulate its physical counterpart. Recent breakthroughs in scientific computation, artificial intelligence, and sensor technology have enabled rapid bidirectional interactions between the virtual-physical counterparts with measurements of the physical twin that inform and improve its virtual twin, which in turn provide updated virtual projections of disease trajectories and anticipated clinical outcomes. Verification, validation, and uncertainty quantification builds confidence and trust by clinicians and patients in the digital twin and establishes boundaries for the use of simulations in cardiovascular medicine. Mechanistic physiological models form the fundamental building blocks of the personalized digital twin that continuously forecast optimal management of cardiovascular health using individualized data streams. We present exemplars from the existing body of literature pertaining to mechanistic model development for cardiovascular dynamics and summarize existing technical challenges and opportunities pertaining to the foundation of a digital twin.

Prognostic value of dobutamine stress echocardiography for the long-term outcomes in kidney transplant candidates.

Cardiovascular disease is a primary cause of morbidity and mortality in kidney transplant (KT) candidates. Dobutamine stress echocardiography (DSE) is an effective noninvasive modality for evaluating coronary artery disease with high accuracy. However, long-term data in KT candidates are still lacking. This study aims to assess the prognostic value of DSE in predicting long-term outcomes in KT candidates. This study retrospectively included consecutive KT candidates who underwent preoperative DSE between 2007 and 2017 at Siriraj Hospital, Bangkok, Thailand. Normal DSE was characterized by the absence of wall motion abnormalities both at rest and during stress. The primary endpoint was all-cause mortality. Univariable and multivariable analyses were conducted to determine predictors of all-cause mortality, with a P value of <0.05 considered statistically significant. Among 269 patients (mean age 51 years, 58% male), 34 (12.6%) had abnormal DSE results, and 63 (23%) underwent kidney transplantation after DSE. During a median follow-up period of 7.6 (4.5, 10.1) years, 129 (48%) patients died. Patients with abnormal DSE had a significantly higher mortality rate than those with normal DSE (73.5% vs. 44.2%, P=0.003). Univariable analysis demonstrated that male gender [hazard ratio (HR) 1.50, 95% confidence interval (CI): 1.04-2.16, P=0.03], resting systolic blood pressure (HR 1.006, 95% CI: 1.00-1.01, P=0.04), abnormal DSE (HR 1.95, 95% CI: 1.25-3.05, P=0.003), higher delta wall motion score index (HR 2.57, 95% CI: 1.24-5.35, P=0.01), abnormal stress left ventricular end-systolic volume (HR 2.05, 95% CI: 1.11-3.82, P=0.02), and post-KT status (HR 0.48, 95% CI: 0.30-0.79, P=0.004) were associated with mortality. In the multivariable analysis, male gender and abnormal DSE were independent predictors of mortality [adjusted HR (aHR) 1.65, 95% CI: 1.06-2.20, P=0.02 and aHR 1.88, 95% CI: 1.20-2.93, P=0.006, respectively], while post-KT status emerged as an independent predictor of better outcomes (aHR 0.47, 95% CI: 0.29-0.77, P=0.003). In KT candidates, preoperative assessment with DSE provides valuable prognostic information for long-term outcomes, particularly regarding all-cause mortality.