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Background Mechanical thrombectomy has changed the landscape of acute ischemic stroke treatment, offering improved outcomes for patients with large vessel occlusions. The interplay between reperfusion techniques and occlusion sites remains a critical consideration in treatment decisions. This study investigates the impact of primary reperfusion techniques—stent retriever classic, stent retriever combination with aspiration, and direct aspiration—on procedural and clinical outcomes at different occlusion sites. Methods Using data from the ASSIST registry, a prospective multinational initiative, patients with anterior circulation acute ischemic stroke with large vessel occlusions (n = 1477) were included. Three primary occlusion sites—M1 segment of the middle cerebral artery, M2 segment of the middle cerebral artery, and the internal carotid artery—were studied. Univariate tests and multivariable logistic regression models were used to assess associations between reperfusion techniques and procedural and clinical outcomes, including the expanded thrombolysis in cerebral infarction score and the modified Rankin Scale, stratified by occlusion site. Results Achieving expanded thrombolysis in cerebral infarction ≥2c after first pass was lower in internal carotid artery occlusions (18.2%, P

Although current policies discourage the use of corporal punishment (CP), its use is still widespread in the US. The objective of this study was to assess the proportion of parents who used CP during the pandemic and identify related risk and protective factors. We analyzed results of a nationwide cross-sectional internet panel survey of 9000 US caregivers who responded in three waves from November 2020 to July 2021. One in six respondents reported having spanked their child in the past week. Spanking was associated with intimate partner violence and the use of multiple discipline strategies and not significantly associated with region or racial self-identification. Parents who spanked sought out more kinds of support, suggesting an opportunity to reduce spanking through more effective parenting resources. Additionally, these results suggest that parents who report using CP may be at risk for concurrent domestic violence.

Objective: Obesity affects 14.7 million children and adolescents in the United States. Children's health behaviors are affected by parental health practices. Therefore, pediatric obesity interventions should include parents. The objective of this study was to assess the changes in self-reported health behaviors in a diverse population attending the TEEEN program, with motivational interviewing of child-parent dyads as a key component, for 1 year. Methods: Here we assessed the changes in Family and Nutrition and Physical Activity (FNPA) screening tool scores, a tool that assesses obesogenic behaviors, in the context of MI of child-parent dyads in a racially, ethnically, and socioeconomically diverse population who attended the TEEEN (Teens, Empowerment, Education, Exercise, Nutrition) program, a nonclinic and family-based behavior program in Massachusetts, for 1 year. Results: Participation in the TEEEN program, which includes MI of child-parent dyads, was associated with a significant increase in the overall FNPA score (median change= 4 points, P = .007). We observed that 76.5% of children experienced a decrease in BMI% and BMI z-score. The change in BMI% (median= −0.9, P = .006) and change in BMI z-score (median= −0.2, P = .008) were statistically significant. Conclusion: Participation in the TEEEN program seemed to be beneficial based on aspects of the FNPA screening tool and changes in weight parameters. The FNPA screening tool enhanced-motivational interviewing of child-parent dyads shows promise as an approach to address obesogenic behaviors. This study provides a detailed framework for medical providers to address pediatric obesity in a nonclinic setting with less time constraints.

Abstract Background Interstitial lung abnormalities (ILA) are CT findings suggestive of interstitial lung disease in individuals without a prior diagnosis or suspicion of ILD. Previous studies have demonstrated that ILA are associated with clinically significant outcomes including mortality. The aim of this study was to determine the prevalence of ILA in a large CT lung cancer screening program and the association with clinically significant outcomes including mortality, hospitalizations, cancer and ILD diagnosis. Methods This was a retrospective study of individuals enrolled in a CT lung cancer screening program from 2012 to 2014. Baseline and longitudinal CT scans were scored for ILA per Fleischner Society guidelines. The primary analyses examined the association between baseline ILA and mortality, all-cause hospitalization, and incidence of lung cancer. Kaplan–Meier plots were generated to visualize the associations between ILA and lung cancer and all-cause mortality. Cox regression proportional hazards models were used to test for this association in both univariate and multivariable models. Results 1699 subjects met inclusion criteria. 41 (2.4%) had ILA and 101 (5.9%) had indeterminate ILA on baseline CTs. ILD was diagnosed in 10 (24.4%) of 41 with ILA on baseline CT with a mean time from baseline CT to diagnosis of 4.47 ± 2.72 years. On multivariable modeling, the presence of ILA remained a significant predictor of death, HR 3.87 (2.07, 7.21; p

Introduction: Non-specific pattern (NSP) is a subgroup of preserved ratio impaired spirometry (PRISm) that requires a normal total lung capacity measurement. NSP has been historically classified as being an obstructive lung disease pattern. There has been heightened interest and investigation into PRISm recently as it has been associated with an increased likelihood of developing chronic obstructive pulmonary disease (COPD). Given the inherent challenges of understanding the clinical significance of the NSP, the aim of this study was to further explore the clinical characteristics of patients with this pulmonary function test pattern. Material and methods: We identified 111 and 79 subjects using pre-bronchodilator (pre-BD) and post-bronchodilator (post-BD) values, respectively, that met criteria for NSP. The outpatient medical records were retrospectively reviewed for associated diagnoses that were then clustered into ‘obstructive’ or ‘non-obstructive’ groups based on the treating physician's primary pulmonary clinical diagnosis. Results: Within this NSP cohort, cough, wheezing and sputum production were documented more frequently in those with an obstructive lung disease diagnosis. Whether identified using pre-BD or post-BD spirometric values, those with NSP and a positive BD response were more likely to carry an obstructive lung disease diagnosis. Conclusion: Approximately one third of patients with NSP in this study were not given an obstructive lung disease diagnosis by their clinician, which supports the classification of NSP as not an exclusively obstructive lung disease pattern. However, the presence of supporting clinical symptoms, such as cough with sputum production and wheeze, and/or a positive BD response on PFT, support a diagnosis of obstruction in patients with NSP. Resumen: Introducción: El patrón inespecífico constituye un subgrupo de alteraciones de la espirometría con conservación de la relación (PRISm, siglas en inglés) que precisa de una medición de la capacidad pulmonar total normal; históricamente se ha clasificado como un patrón de neumopatía obstructiva. En épocas recientes se ha intensificado el interés en las PRISm y su investigación, ya que se ha asociado a un aumento de la probabilidad de aparición de una enfermedad pulmonar obstructiva crónica (EPOC). Dadas las dificultades inherentes que conlleva interpretar la importancia clínica del patrón inespecífico, el objetivo de este estudio consistió en explorar con más detalle las características clínicas de los pacientes con dicho patrón en las pruebas de la función pulmonar. Material y métodos: Se identificaron 111 y 79 sujetos empleando valores prebroncodilatador y posbroncodilatador, respectivamente, que cumplieron los criterios de patrón inespecífico. Se revisaron retrospectivamente las historias clínicas ambulatorias para detectar diagnósticos asociados que después se agregaron en grupos «obstructivos» o «no obstructivos» en función del diagnóstico clínico pulmonar primario del médico. Resultados: En esta cohorte de pacientes con patrones inespecíficos, se documentó una mayor incidencia de tos, sibilancias y producción de esputo entre los que tenían un diagnóstico de neumopatía obstructiva. Los pacientes con patrón inespecífico y una respuesta positiva al broncodilatador, que hubiesen sido identificados con valores pre o posbroncodilatador, tenían más probabilidades de haber recibido un diagnóstico de neumopatía obstructiva. Conclusión: Aproximadamente un tercio de los pacientes con patrón inespecífico de este estudio no habían recibido un diagnóstico de neumopatía obstructiva, dato que avala no clasificar los patrones inespecíficos exclusivamente en las neumopatías obstructivas. Sin embargo, la presencia de síntomas clínicos indicativos, como tos productiva y sibilancias, o una respuesta positiva al broncodilatador en las pruebas de la función pulmonar, sustenta un diagnóstico de obstrucción en los pacientes con patrón inespecífico.

Background Severe cardiac cachexia or malnutrition are commonly considered relative contraindications to left ventricular assist device (LVAD) implantation, but post‐LVAD prognosis for patients with cachexia is uncertain. Methods and Results Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) 2006 to 2017 was queried for the preimplantation variable cachexia/malnutrition. Cox proportional hazards modeling examined the relationship between cachexia and LVAD outcomes. Of 20 332 primary LVAD recipients with available data, 516 (2.54%) were reported to have baseline cachexia and had higher risk baseline characteristics. Cachexia was associated with higher mortality during LVAD support (unadjusted hazard ratio [HR], 1.36 [95% CI, 1.18–1.56]; P

Abstract Background Recruitment of fibromyalgia populations into long-term clinical trials involving exercise interventions is a challenge. We evaluated the cost and randomization yields of various recruitment methods used for a fibromyalgia trial in an urban setting. We also investigated differences in participant characteristics and exercise intervention adherence based on recruitment source. Methods We recruited individuals with fibromyalgia in the greater Boston area to a randomized controlled trial (RCT) using six recruitment strategies: newspaper advertisements, web advertisements, flyers, clinic referrals, direct mailing to patients in a clinic database, and word of mouth. We used the American College of Rheumatology 1990 and 2010 diagnostic criteria to screen and enroll participants. During an initial phone call to an interested participant, the study staff asked how they heard about the study. In this study, we compared the cost and yield of the six recruitment strategies as well as baseline characteristics, adherence, and attendance rates of participants across strategies. Results Our recruitment resulted in 651 prescreens, 272 screening visits, and 226 randomized participants. Advertisements in a local commuter newspaper were most effective, providing 113 of 226 randomizations, albeit high cost ($212 per randomized participant). Low-cost recruitment strategies included clinical referrals and web advertisements, but they only provided 32 and 16 randomizations. Community-based strategies including advertisement and flyers recruited a more racially diverse participant sample than clinic referrals and mailing or calling patients. There was no evidence of difference in adherence among participants recruited from various strategies. Conclusions Newspaper advertisement was the most effective and most expensive method per randomized participant for recruiting large numbers of individuals with fibromyalgia in an urban setting. Community-based strategies recruited a more racially diverse cohort than clinic-based strategies. Trial registration ClinicalTrials.gov NCT01420640 . Registered on 19 August 2011.

The purpose of this multi-institutional retrospective study was to expand the available data pertaining to pre-operative clinical findings, progression-free and overall survival times, and potential prognostic factors for cats undergoing surgery for intestinal adenocarcinomas. Fifty-eight cats treated over a 12-year period were included in the study. Progression-free and overall survival times were estimated using Kaplan-Meier analyses. Potential prognostic variables were evaluated for associations with progression-free and overall survival using univariate Cox proportional hazards regression analyses. Prior to surgery, the intestinal mass was identified using ultrasonography in 89% of cats in which it was applied; however, imaging findings suggestive of intrathoracic metastases were observed in only 9% of cats. Among 22 cats undergoing ultrasound-guided fine needle aspiration cytology, the results agreed with the results of histopathology in only 10 cats. Discordant results were most commonly related to the presence of marked inflammation in cytology samples, which may have obscured the presence of neoplastic cells. Diffuse intestinal small cell lymphoma was identified as a comorbidity in 5 cats. Resection of the tumor with the objective of obtaining wide surgical margins was performed in each cat. On histopathology, 20 tumors were classified as mucinous adenocarcinoma and 28 were adenocarcinoma not otherwise specified. Intestinal transection site margins were complete in 94% of cats; however, complete mural margins were present in only 15% of cats. Local lymph node metastases were identified in 52% of cats and carcinomatosis was diagnosed in 81% of cats. Disease progression was documented in 32 of the 58 cats (55%). Of these 32 cats, 14 (43%) had local recurrence of the primary intestinal tumor. Median progression-free survival was 203 days (95% CI 130–299 days), and median overall survival time was 284 days (95% CI 200–363 days). Mitotic count was inversely associated with progression-free survival (HR 1.04; 95% CI 1.01–1.07, P = 0.005); however, none of the remaining potential prognostic factors, including administration of adjuvant chemotherapy, were significantly associated with progression-free or overall survival. Feline intestinal adenocarcinoma remains an aggressive and highly fatal disease. Large, randomized controlled clinical trials will be needed to improve the survival prospects for affected cats.

ObjectiveResidual scarring after cleft lip repair surgery remains a challenge for both surgeons and patients and novel therapeutics are critically needed. The objective of this preclinical experimental study was to evaluate the impact of the methyl-ester of pro-resolving lipid mediator lipoxin A4 (LXA4-ME) on scarring in a novel rabbit model of cleft lip repair.MethodsA defect of the lip was surgically created and repaired in eight six-week old New Zealand white rabbits to simulate human cleft lip scars. Rabbits were randomly assigned to topical application of PBS (control) or 1 ug of LXA4-ME (treatment). 42 days post surgery all animals were euthanized. Photographs of the cleft lip area defect and histologic specimens were evaluated. Multiple scar assessment scales were used to compare scarring.ResultsAnimals treated with LXA4-ME exhibited lower Visual Scar Assessment scores compared to animals treated with PBS. Treatment with LXA4-ME resulted in a significant reduction of inflammatory cell infiltrate and density of collagen fibers. Control animals showed reduced 2D directional variance (orientation) of collagen fibers compared to animals treated with LXA4-ME demonstrating thicker and more parallel collagen fibers, consistent with scar tissue.ConclusionsThese data suggest that LXA4-ME limits scarring after cleft lip repair and improves wound healing outcomes in rabbits favoring the resolution of inflammation. Further studies are needed to explore the mechanisms that underlie the positive therapeutic impact of LXA4-ME on scarring to set the stage for future human clinical trials of LXA4-ME for scar prevention or treatment after cleft lip repair.

Abstract Background Osteoarthritis is generally a slowly progressive disorder. However, at least 1 in 7 people with incident knee osteoarthritis develop an abrupt progression to advanced-stage radiographic disease, many within 12 months. We summarize what is known – primarily based on findings from the Osteoarthritis Initiative – about the risk factors and natural history of accelerated knee osteoarthritis (AKOA) – defined as a transition from no radiographic knee osteoarthritis to advanced-stage disease

Abstract Background We aimed to determine if composite structural measures of knee osteoarthritis (KOA) progression on magnetic resonance (MR) imaging can predict the radiographic onset of accelerated knee osteoarthritis. Methods We used data from a nested case-control study among participants from the Osteoarthritis Initiative without radiographic KOA at baseline. Participants were separated into three groups based on radiographic disease progression over 4 years: 1) accelerated (Kellgren-Lawrence grades [KL] 0/1 to 3/4), 2) typical (increase in KL, excluding accelerated osteoarthritis), or 3) no KOA (no change in KL). We assessed tibiofemoral cartilage damage (four regions: medial/lateral tibia/femur), bone marrow lesion (BML) volume (four regions: medial/lateral tibia/femur), and whole knee effusion-synovitis volume on 3 T MR images with semi-automated programs. We calculated two MR-based composite scores. Cumulative damage was the sum of standardized cartilage damage. Disease activity was the sum of standardized volumes of effusion-synovitis and BMLs. We focused on annual images from 2 years before to 2 years after radiographic onset (or a matched time for those without knee osteoarthritis). To determine between group differences in the composite metrics at all time points, we used generalized linear mixed models with group (3 levels) and time (up to 5 levels). For our prognostic analysis, we used multinomial logistic regression models to determine if one-year worsening in each composite metric change associated with future accelerated knee osteoarthritis (odds ratios [OR] based on units of 1 standard deviation of change). Results Prior to disease onset, the accelerated KOA group had greater average disease activity compared to the typical and no KOA groups and this persisted up to 2 years after disease onset. During a pre-radiographic disease period, the odds of developing accelerated KOA were greater in people with worsening disease activity [versus typical KOA OR (95% confidence interval [CI]): 1.58 (1.08 to 2.33); versus no KOA: 2.39 (1.55 to 3.71)] or cumulative damage [versus typical KOA: 1.69 (1.14 to 2.51); versus no KOA: 2.11 (1.41 to 3.16)]. Conclusions MR-based disease activity and cumulative damage metrics may be prognostic markers to help identify people at risk for accelerated onset and progression of knee osteoarthritis.

Abstract Background Stable health insurance is often associated with better chronic disease care and outcomes. Racial/ethnic health disparities in outcomes are prevalent and may be associated with insurance instability, particularly in the context of health insurance reform. Methods We examined whether insurance instability was associated with uncontrolled blood pressure (UBP) and whether this association varied by race/ethnicity. We used a retrospective longitudinal observational cohort study of patients diagnosed with hypertension who obtained care within two health systems in Massachusetts. We measured the UBP, insurance instability, and race of 43,785 adult primary care patients, age 21–64 with visits from 1/2005–12/2013. Results We found higher rates of UBP for blacks and Hispanics at each time point over the entire 9 years. Insurance instability was associated with greater rates of UBP. Always uninsured black patients fared worst, while white and Hispanic patients with consistent public insurance fared best. Conclusions Stable insurance of any type was associated with better hypertension control than no or unstable insurance.

Objective To determine if people with incident accelerated knee osteoarthritis (AKOA) were more likely to receive a pharmacological treatment or arthroscopic knee surgery than those with typical knee osteoarthritis (KOA) or no KOA. Methods We conducted a nested cohort study using data from baseline and the first 8 years of the Osteoarthritis Initiative. Eligible participants had no radiographic KOA at baseline (Kellgren‐Lawrence [KL] < 2). We classified three groups using KL grades: 1) AKOA: knee progressed to advanced‐stage KOA (KL 3/4) in 4 years or less, 2) typical KOA: knee increased in KL grade by 8 years (excluding AKOA), and 3) No KOA: no change in KL grade by 8 years. The outcome was self‐reported arthroscopic knee surgery or a pharmacological treatment option: nonsteroidal anti‐inflammatory drugs (NSAIDs), hyaluronic acid injections, intra‐articular corticosteroid injections, or prescription analgesics. Between‐group differences in therapeutic use were evaluated with Chi‐square tests. Results Adults who developed AKOA (n = 92) were more likely to report arthroscopic knee surgery (AKOA: 32%, KOA [n = 380]: 8%, no KOA [n = 875]: 3%; P < 0.001), hyaluronic acid injections (AKOA: 10%, KOA: 4%, no KOA: 1%; P < 0.001), intra‐articular corticosteroid injections (AKOA: 30%, KOA: 7%, no KOA: 4%; P < 0.001), and NSAID use (over the counter: AKOA: 65%, KOA: 48%, and no KOA: 46%; P = 0.003; prescription: AKOA: 61%, KOA: 43%, no KOA: 41%; P = 0.002). Conclusion Adults with AKOA are more likely to receive pharmacological treatment or arthroscopic knee surgery than their peers. Adults with AKOA are an important patient population that is understudied in clinical research despite their use of greater health care resources.

Abstract Background To determine if adults with incident accelerated knee osteoarthritis (KOA) are more likely to have degenerative knee ligaments or tendons compared to individuals with typical or no KOA. Methods We identified 3 sex-matched groups among Osteoarthritis Initiative participants who had a knee without radiographic KOA at baseline (Kellgren-Lawrence [KL]

Abstract Background Accelerated knee osteoarthritis (AKOA) is characterized by more pain, impaired physical function, and greater likelihood to receive a joint replacement compared to individuals who develop the typical gradual onset of disease. Prognostic tools are needed to determine which structural pathologies precede the development of AKOA compared to individuals without AKOA. Therefore, the purpose of this manuscript was to determine which pre-radiographic structural features precede the development of AKOA. Methods The sample comprised participants in the Osteoarthritis Initiative (OAI) who had at least one radiographically normal knee at baseline (Kellgren-Lawrence [KL] grade 3) and No AKOA. The index visit was the study visit when participants met criteria for AKOA or a matched timepoint for those who did not develop AKOA. Magnetic resonance (MR) images were assessed for 12 structural features at the OAI baseline, and 1 and 2 years prior to the index visit. Separate logistic regression models (i.e. OAI baseline, 1 and 2 years prior) were used to determine which pre-radiographic structural features were more likely to antedate the development of AKOA compared to individuals not developing AKOA. Results At the OAI baseline visit, degenerative cruciate ligaments (Odds Ratio [OR] = 2.2, 95% Confidence Interval [CI] = 1.3,3.5), infrapatellar fat pad signal intensity alteration (OR = 2.0, 95%CI = 1.2,3.2), medial/lateral meniscal pathology (OR = 2.1/2.4, 95%CI = 1.3,3.4/1.5,3.8), and greater quantitative knee effusion-synovitis (OR = 2.2, 95%CI = 1.4,3.4) were more likely to antedate the development of AKOA when compared to those that did not develop AKOA. These results were similar at one and two years prior to disease onset. Additionally, medial meniscus extrusion at one year prior to disease onset (OR = 3.5, 95%CI = 2.1,6.0) increased the likelihood of developing AKOA. Conclusions Early ligamentous degeneration, effusion/synovitis, and meniscal pathology precede the onset of AKOA and may be prognostic biomarkers.

Abstract Objective Examine whether pre‐intervention physical activity (PA) level is associated with achieving a positive treatment response of pain and/or function improvement after a 12‐week exercise intervention in participants with knee osteoarthritis (OA). Methods We performed a secondary analysis of a randomized, single‐blind comparative effectiveness trial showing similar treatment effects between Tai Chi mind‐body exercise and standard physical therapy intervention for knee OA. Baseline PA was assessed by a Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire and, in a subsample, by tri‐axial accelerometers. The Outcome Measures in Rheumatoid Arthritis Clinical Trials–Osteoarthritis Research Society International (OMERACT‐OARSI) dichotomous responder criteria was used for clinically meaningful improvement at follow‐up. Associations between baseline self‐reported PA by the CHAMPS questionnaire and outcomes of responders vs. nonresponders (reference group) were assessed using logistic regressions, adjusting for demographic covariates. We compared objectively measured PA by accelerometry between responders vs. nonresponders using Wilcoxon tests. Results Our sample consisted of 166 participants with knee OA who completed both baseline and 12‐week postintervention evaluations: mean age 60.7 year (SD 10.5), body mass index 32.4 kg/m2 (6.9), 119 (72%) women, and 138 (83%) OMERACT‐OARSI responders. Neither time spent in total PA [odds ratio (OR) 1.00; 95% confidence interval (CI) 0.96, 1.03] nor time in moderate‐to‐vigorous PA (OR 1.01; 95% CI 0.93, 1.09) at pre‐intervention were associated with being a responder. Similar findings were observed in 42 accelerometry sub‐cohort participants. Conclusion Pre‐intervention PA levels (subjective report or objective measurement) were not associated with individuals achieving favorable treatment outcomes after a 12‐week exercise intervention, which suggests that regardless of pre‐intervention PA level, individuals will likely benefit from structured exercise interventions.

Employers have begun to offer voluntary workplace genomic testing (wGT) as part of employee wellness benefit programs, but few empirical studies have examined the ethical, legal, and social implications (ELSI) of wGT. To better understand employee perspectives on wGT, employees were surveyed at a large biomedical research institution. Survey respondents were presented with three hypothetical scenarios for accessing health-related genomic testing: via (1) their doctor; (2) their workplace; and 3) a commercial direct-to-consumer (DTC) genetic testing company. Overall, 594 employees (28%) responded to the survey. Respondents indicated a preference for genomic testing in the workplace setting (70%; 95% CI 66–74%), followed by doctor’s office (54%; 95% CI 50–58%), and DTC testing (20%; 95% CI 17–24%). Prior to participating in wGT, respondents wanted to know about confidentiality of test results (79%), existence of relevant laws and policies (70%), and privacy protection (64%). Across scenarios, 92% of respondents preferred to view the test results with a genetic counselor. These preliminary results suggest that many employees are interested and even prefer genetic testing in the workplace and would prefer testing with support from genetic health professionals. Confirmation in more diverse employer settings will be needed to generalize such findings.

Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician’s input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies.

Methods. This observational retrospective cohort study includes 318 ARDS patients extracted from an ICU database between the years of 2001 and 2008. Clinical factors including age, gender, comorbidity score, Sequential Organ Failure Assessment (SOFA) score, and PaO2/FiO2 ratio were chosen for the base model to predict ICU mortality. The RDW value at the time of ARDS diagnosis was added to the base model to determine if it improved its predictive ability. Results. 318 subjects were included; 113 (36%) died in the ICU. AUC for the base model without RDW was 0.76, and 0.78 following the addition of RDW [p=0.048]. The NRI was 0.46 (p=0.001), indicating that, in 46% of patients, the predictive probability of the model was improved by the inclusion of RDW. Conclusions. Adding RDW at time of ARDS diagnosis improved discrimination in a model using 4 clinical factors to predict ICU mortality.

Abstract Background Greater age and body mass index are strong risk factors for osteoarthritis (OA). Older and overweight individuals may be more susceptible to OA because these factors alter tissue turnover in menisci, articular cartilage, and bone via altered glucose homeostasis and inflammation. Understanding the role of inflammation and glucose homeostasis on structural features of early-stage OA may help identify therapeutic targets to delay or prevent the onset of OA among subsets of adults with these features. We examined if serum concentrations of glucose homeostasis (glucose, glycated serum protein [GSP]) or inflammation (C-reactive protein [CRP]) were associated with prevalent knee bone marrow lesions (BMLs) or effusion among adults without knee OA. Methods We conducted a cross-sectional study using baseline data from the Osteoarthritis Initiative. We selected participants who had no radiographic knee OA but were at high risk for knee OA. Blinded staff conducted assays for CRP, GSP, and glucose. Readers segmented BML volume and effusion using semi-automated programs. Our outcomes were prevalent BML (knee with a BML volume > 1 cm3) and effusion (knee with an effusion volume > 7.5 cm3). We used logistic regression models with CRP, GSP, or glucose concentrations as the predictors. We adjusted for age, sex, body mass index (BMI), and Physical Activity Scale for the Elderly (PASE) scores. Results We included 343 participants: mean age = 59 ± 9 years, BMI = 27.9 ± 4.5 kg/m2, PASE score = 171 ± 82, and 64% female. Only CRP was associated with BML prevalence (odds ratio [OR] = 1.43, 95% confidence interval [CI] = 1.09 to 1.87). For effusion, we found an interaction between BMI and CRP: only among adults with a BMI

Abstract Background Risk prediction algorithms increase understanding of which patients are at greatest risk of a harmful outcome. Our goal was to create a clinically useful prediction algorithm for structural progression of knee osteoarthritis (OA), using medial joint space loss as a proxy; and to quantify the benefit of including periarticular bone mineral density (BMD) in the algorithm. Methods Participants were from the Osteoarthritis Initiative (OAI) Progression Cohort, with X-ray readings of medial joint space at 36- and 48-month visits, and a 30- or 36-month medial-to-lateral tibial BMD ratio (M:L BMD ratio) value. Loss of medial joint space was the outcome and clinically available factors associated with OA progression were employed in the base prediction algorithm, with M:L BMD ratio added to an enhanced prediction algorithm. The benefit of adding M:L BMD ratio was evaluated by change in area under the ROC curve (AUC), net reclassification improvement (NRI), and integrated discrimination improvement (IDI). Results Five hundred thirty-three participants were included; 51 (14%) had medial joint space loss; 47% were female; the mean (SD) age was 64.6 (9.2) years and BMI was 29.6 (4.8) kg/m2. The base algorithm model included age, BMI, gender, recent injury, knee pain, and hand OA as predictors and had an AUC value of 0.65. The algorithm adding M:L BMD ratio had an AUC value of 0.73, and the AUC, NRI and IDI were all significantly improved (p ≤ 0.002). Conclusions This clinical prediction algorithm predicts structural progression in individuals with OA using only clinically available predictors supplemented by the M:L BMD ratio, a biomarker that could be made available at clinical sites.

ABSTRACT IMPACT: The integration of patient-reported outcome measures into clinical care is feasible and can facilitate patient-centered care for individuals with systemic lupus erythematosus. OBJECTIVES/GOALS: Patient-reported outcome measures (PROMs) are powerful tools which can facilitate patient-centered care by highlighting individuals’ experience of illness. The aim of this study was to assess the feasibility and impact of implementing web-based PROMs in the routine clinical care of outpatients with systemic lupus erythematosus (SLE). METHODS/STUDY POPULATION: Outpatients with SLE were enrolled in this longitudinal cohort study at two academic medical centers. Participants completed PROMIS computerized adaptive tests assessing multiple quality of life domains at enrollment and prior to two consecutive routinely scheduled rheumatology visits using the ArthritisPower research registry mobile or web-based application. Score reports were shared with patients and providers before the visits. Patients and rheumatologists completed post-visit surveys evaluating the utility of PROMs in the clinical encounters. Proportions with confidence intervals were calculated to evaluate survey completion rates and responses. RESULTS/ANTICIPATED RESULTS: A total of 105 SLE patients and 16 rheumatologists participated in the study. Subjects completed PROMs in 159 of 184 eligible encounters (86%, 95% CI 81 - 91), including 90% of visit 1’s (95% CI 82 - 95) and 82% of visit 2’s (95% CI 72 - 90. Patients and rheumatologists found that PROMs were useful (91% and 83% of encounters respectively) and improved communication (86% and 72%). Rheumatologists reported that PROMs impacted patient management in 51% of visits, primarily by guiding conversations (84%), but also by influencing medication changes (15%) and prompting referrals (10%). There was no statistically significant difference in visit length before (mean=19.5 min) and after (mean=20.4 min) implementation of PROMs (p=0.52). DISCUSSION/SIGNIFICANCE OF FINDINGS: The remote capture and integration of web-based PROMs into clinical care was feasible in a diverse cohort of SLE outpatients. PROMs were useful to SLE patients and rheumatologists and promoted patient-centered care by facilitating communication.

Rationale. The impact of emergency department length of stay (EDLOS) upon sepsis outcomes needs clarification. We sought to better understand the relationship between EDLOS and both outcomes and protocol compliance in sepsis. Methods. We performed a retrospective observational study of septic patients admitted to the ICU from the ED between January 2012 and December 2015 in a single tertiary care teaching hospital. 287 patients with severe sepsis and septic shock were included. Study population was divided into patients with EDLOS < 6 hrs (early admission) versus ≥6 hours (delayed admission). We assessed the impact of EDLOS on hospital mortality, compliance with sepsis protocol, and resuscitation. Statistical significance was determined by chi-square test. Results. Of the 287 septic ED patients, 137 (47%) were admitted to the ICU in

Personnel in Armed Forces entities such as the US Coast Guard (USCG) engage in strenuous tasks requiring high levels of physiological and psychological fitness. Previous reports have found increased prevalence of dietary supplement (DS) use by military personnel to meet the demands of their occupation.This study assessed DS prevalence and patterns of use in USCG personnel and compared these findings to reports from other Armed Forces personnel.Use of DS by USCG personnel (n = 1059) was assessed by survey at USCG installations. Data were weighted by age, sex, and rank to be representative of total USCG demographics.Seventy percent of USCG personnel reported using a DS at least 1 time/wk. Thirty-three percent used 1-2 DS ≤ 1 time/wk, 18% 3-4 DS ≥ 1 time/wk, and almost 19% ≥ 5 DS ≥ 1 time/wk. Average expenditure on DSs by UCSG personnel was $40/mo. More than 47% of USCG personnel used a multivitamin and mineral, 33% consumed protein supplements, 22% used individual vitamins and minerals, 23% reported taking combination products, and 9% consumed herbal supplements. Increased use of DS use was associated with high intensity operational occupations, participating in high volumes of aerobic exercise and strength training. Use of DS was not associated with age, education or body mass index.Occupation is an important determinate of DS use. Prevalence of DS use by USCG personnel is greater than reported for other Armed Forces personnel and reflects high levels of participation in aerobic and strength training activities.

Metabolic profiling may provide insight into biologic mechanisms related to age-related increases in regional adiposity and insulin resistance.The objectives of the current study were to characterize the association between mid-thigh intermuscular and subcutaneous adipose tissue (IMAT, SCAT, respectively) and, abdominal adiposity with the serum metabolite profile, to identify significant metabolites as further associated with the homeostasis model assessment of insulin resistance (HOMA-IR), and, to develop a HOMA-IR associated metabolite predictor set representative of regional adiposity, in 73 functionally-limited (short physical performance battery ≤10; SPPB) older adults (age range, 70-85 y).Fasting levels of 181 total metabolites, including amino acids, fatty acids and acylcarnitines were measured with use of an untargeted mass spectrometry-based metabolomic approach. Multivariable-adjusted linear regression was used in all analyses.Thirty-two, seven and one metabolite(s) were found to be associated with IMAT, abdominal adiposity and, SCAT, respectively, including the amino acid glycine, which was positively associated with SCAT and, negatively associated with both IMAT and abdominal adiposity. Glycine and four metabolites found to be significantly associated with regional adiposity were additionally associated with HOMA-IR. Separate stepwise regression models identified glycine as a HOMA-IR associated marker of both IMAT (model R(2) = 0.51, p