bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness and Safety of Magseed Localization for Excision of Breast Lesions
Authors: Singh Puneet , Scoggins Marion E. , Sahin Aysegul A. , Hwang Rosa F. , Kuerer Henry M. , Caudle Abigail S. , Mittendorf Elizabeth A. , Thompson Alastair M. , Bedrosian Isabelle , Teshome Mediget , DeSnyder Sarah M. , Meric-Bernstam Funda , Hunt Kelly K. 
Published: March 2021

Objective:
A prospective, phase IV study was conducted to assess the effectiveness of Magseed to localize breast lesions requiring surgical excision.

Background:
Since Food and Drug Administration approval in 2016, Magseed has been increasingly used to localize nonpalpable lesions due to advantages over wires or radioactive seeds. This is the first prospective, postmarketing trial of Magseed.

Methods:
From January 2017 to February 2018, 107 women with lesions requiring localization were enrolled at a single institution. Primary endpoint was Magseed retrieval rate. Secondary endpoints were adverse events, accuracy of placement, surgery duration, and positive margin rate. Clinicians were surveyed for ease of use using a Likert scale. Descriptive statistics and Fisher exact test were performed to assess univariable associations with positive margins.

Results:
There were 124 Magseeds placed including 1 marker in 93 subjects, 2 markers in 11, and 3 markers in 3. The majority of lesions were masses (63%) followed by calcifications (24%). All 124 Magseeds were placed within 10 mm of the target lesion and surgically retrieved with median operative time of 15 minutes (range, 4–47). No device-related adverse events occurred. Of the 98 malignant lesions, 9 had positive margins and 7 of them underwent a second surgery for additional margins. On univariable analysis, age ≤50 (25.0% vs 6.4%, P = 0.04), lesion histology (P = 0.03), and pathologic T stage (P = 0.04) were significantly associated with positive margins. Clinicians rated the Magseed very or fairly easy to use in most cases.

Conclusions:
The Magseed system for localization of nonpalpable lesions was effective and safe; all markers were successfully retrieved with margin-negative resections in 91%. This study supports use of Magseed for localization of breast lesions.
Using Population Pharmacokinetic Modeling to Estimate Exposure to Δ9-Tetrahydrocannabinol in an Observational Study of Cannabis Smokers in Colorado
Authors: Sempio Cristina , Bidwell L. Cinnamon , Hutchison Kent , Huestis Marilyn A. , Klawitter Jost , Christians Uwe , Henthorn Thomas K. 
Published: March 2021

Background:
Self-report questionnaires, weighing products consumed, and Δ9-tetrahydrocannabinol (THC) biomarkers are established techniques for estimating cannabis exposure. Population pharmacokinetic modeling of plasma THC and metabolite concentrations by incorporating self-reported and weighed products as covariates could improve estimates of THC exposure in regular cannabis users.

Methods:
In this naturalistic study, blood samples were obtained from 36 regular smokers of cannabis for analysis of THC and its 2 metabolites at 4 time points: recruitment and during an experimental mobile laboratory assessment that included 3 time points: before, immediately after, and 1 hour after ad libitum legal market flower use. These data were analyzed using an established model of population pharmacokinetics developed from laboratory-controlled cannabis administration data. Elimination and metabolite production clearances were estimated for each subject as well as their daily THC doses and the dose consumed during the ad libitum event.

Results:
A statistically significant correlation existed between the daily THC dose estimated by self-report questionnaire and population pharmacokinetic modeling (correlation coefficient = 0.79, P < 0.05) between the weighed cannabis smoked ad libitum and that estimated by population pharmacokinetic modeling (correlation coefficient = 0.71, P < 0.05).

Conclusion:
Inclusion of self-reported questionnaire data of THC consumption improved pharmacokinetic model–derived estimates based on measured THC and metabolite concentrations. In addition, the pharmacokinetic-derived dose estimates for the ad libitum smoking event underestimated the THC consumption compared with the weighed amount smoked. Thus, the subjects in this study, who smoked ad libitum and used cannabis products with high concentrations of THC, were less efficient (lower bioavailability) compared with computer-paced smokers of low potency, NIDA cannabis in a laboratory setting.
Cardiovascular outcomes in patients at high cardiovascular risk with previous myocardial infarction or stroke
Authors: Böhm Michael , Schumacher Helmut , Teo Koon K. , Lonn Eva M. , Lauder Lucas , Mancia Giuseppe , Redon Josep , Schmieder Roland E. , Sliwa Karen , Marx Nikolaus , Weber Michael A. , Williams Bryan , Yusuf Salim , Mann Johannes F.E. , Mahfoud Felix 
Published: March 2021

Background:
Guidelines recommend to start blood pressure (BP)-lowering drugs also according to cardiovascular risk including history of cardiovascular events. We hypothesized that in patients with a history of myocardial infarction (MI), stroke, both or none of those, the index events predict the next event and have different SBP risk associations to different cardiovascular outcomes.

Design and measurements:
In this pooled posthoc, nonprespecified analysis, we assessed outcome data from high-risk patients aged 55 years or older with a history of cardiovascular events or proven cardiovascular disease, randomized to the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial and to Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease Trial investigating telmisartan, ramipril and their combination with a median follow-up of 56 months. Standardized office BP was measured every 6 months. Associations of mean achieved BP on treatment were investigated on MI, stroke and cardiovascular death. We identified patients with previous MI (N = 13 487), stroke (N = 4985), both (N = 1509) or none (N = 10 956) of these index events. Analyses were done by Cox regression, analysis of variance and Chi2-test. 30 937 patients with complete data were enrolled between 1 December 2001 and 31 July 2003, and followed until 31 July 2008. Data of both trials were pooled as the outcomes were similar.

Results:
Patients with MI as index event had a higher risk to experience a second MI [hazard ratio 1.42 (confidence interval (CI) 1.20–1.69), P < 0.0001] compared with patients with no events but no increased risk for a stroke as a next event [hazard ratio 0.95 (CI 0.73–1.23), n.s.]. The risk was roughly doubled when they had both, MI and stroke before [hazard ratio 2.07 (CI 1.58–2.71), P < 0.0001]. Patients with a stroke history had a roughly three-fold higher likelihood to experience a second stroke [hazard ratio 2.89 (CI 2.37–3.53) P < 0.0001] but not MI [hazard ratio 1.07 (CI 0.88–1.32), n.s.]. Both types of index events increased roughly three-fold the risk of a second stroke compared with no previous events. The SBP-risk relationship was not meaningfully altered by the event history. After MI and stroke the risk for subsequent events and cardiovascular death was increased over the whole SBP spectrum. A J-shape relationship between BP and outcome was only observed for cardiovascular death.

Conclusion:
Previous MI and previous stroke are associated with increased risk for the same event in the future, independent of achieved SBP. Thus, secondary prevention may also be chosen according to the event history of patients.

Clinical trial registration:

http://clinicaltrials.gov. Unique identifier: NCT00153101.
Psychosocial and Functional Predictors of Depression and Anxiety Symptoms in Veterans and Service Members With TBI: A VA TBI Model Systems Study
Authors: Benavides Angela M. , Finn Jacob A. , Tang Xinyu , Ropacki Susan , Brown Racine M. , Smith Austin N. , Stevens Lillian Flores , Rabinowitz Amanda R. , Juengst Shannon B. , Johnson-Greene Doug , Hart Tessa 
Published: March 2021

Objective:
To identify psychosocial and functional predictors of self-reported depression and anxiety symptoms at year 2 following traumatic brain injury (TBI).

Setting:
Five Department of Veterans Affairs (VA) Polytrauma Rehabilitation Centers (PRCs) within the TBI Model Systems (TBIMS).

Participants:
A total of 319 service members/veterans enrolled in VA TBIMS who were eligible for and completed both 1- and 2-year follow-up evaluations.

Design:
Secondary analysis from multicenter prospective longitudinal study.

Main Measures:
Demographic, injury-related, military, mental health, and substance use variables. Questionnaires included the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Neurobehavioral Symptom Inventory. Rating scales included the Participation Assessment with Recombined Tools–Objective and Disability Rating Scale.

Results:
The final sample was largely male (96%) and predominantly White (65%), with a median age of 27 years. In unadjusted analyses, pre-TBI mental health treatment history and year 1 employment status, community activity, sleep difficulties, and self-reported depression and anxiety symptoms were associated with year 2 PHQ-9 scores; pre-TBI mental health treatment history and year 1 community activity, social contact, problematic substance use, sleep difficulties, and self-reported depression and anxiety symptoms were associated with year 2 GAD-7 scores. In multivariable analyses, only year 1 community activity and depression symptoms uniquely predicted year 2 PHQ-9 scores, and only year 1 employment status, community activity, problematic substance use, and anxiety symptoms uniquely predicted year 2 GAD-7 scores.

Conclusion:
Anxiety and depression commonly occur after TBI and are important treatment targets. Some predictors (eg, participation and substance use) are modifiable and amenable to treatment as well. Early identification of anxiety and depression symptoms is key.
Cognitive Recovery During Inpatient Rehabilitation Following Pediatric Traumatic Brain Injury: A Pediatric Brain Injury Consortium Study
Authors: Watson William D. , Suskauer Stacy J. , Askin Gulce , Nowak Sophie , Baum Katherine T. , Gerber Linda M. , Blackwell Laura S. , Koterba Christine H. , Hoskinson Kristen R. , Kurowski Brad G. , Mclaughlin Matthew J. , Tlustos Sarah J. , Zimmerman Kanecia O. , Shah Sudhin A. 
Published: March 2021

Objectives:
To characterize the demographics, clinical course, and predictors of cognitive recovery among children and young adults receiving inpatient rehabilitation following pediatric traumatic brain injury (TBI).

Design:
Retrospective observational, multicenter study.

Setting:
Eight acute pediatric inpatient rehabilitation facilities in the United States with specialized programs for treating patients with TBI.

Participants:
Children and young adults (0-21 years) with TBI (n = 234) receiving inpatient rehabilitation.

Interventions:
Not applicable.

Main Outcome Measures:
Admission and discharge status assessed by the WeeFIM Cognitive Developmental Functional Quotient (DFQ) and Cognitive and Linguistic Scale (CALS).

Results:
Patients admitted to pediatric inpatient rehabilitation are diverse in cognitive functioning. While the majority of patients make improvements, cognitive recovery is constrained for those admitted with the most severe cognitive impairments. Age, time since injury to rehabilitation admission, and admission WeeFIM Cognitive DFQ are significant predictors of cognitive functioning at discharge from inpatient rehabilitation.

Conclusions:
This work establishes a multicenter Pediatric Brain Injury Consortium and characterized the demographics and clinical course of cognitive recovery during inpatient rehabilitation of pediatric patients with TBI to aid in prospective study design.
Vestibular, Oculomotor, and Balance Functions in Children With and Without Concussion
Authors: Cochrane Graham D. , Christy Jennifer B. , Almutairi Anwar , Busettini Claudio , van Heyningen Hendrik K. Kits , Weise Katherine K. , Swanson Mark W. , Gould Sara J. 
Published: March 2021

Objective:
The main objective of this study was to assess whether objective vestibular, oculomotor, and balance functions were impaired in children with a current diagnosis of concussion with vestibular and/or ocular symptoms.

Setting:
Data were collected in a vestibular/ocular clinical laboratory. Patient participants were recruited from a concussion clinic in a children's hospital.

Participants:
Thirty-three children aged 8 to 17 years with a current diagnosis of concussion and vestibular and/or ocular symptoms and 30 children without concussion.

Design:
Cross-sectional single-visit study.

Main Outcome Measures:
Eye-tracking rotary chair oculomotor and vestibular measures, vestibular evoked potentials, and static posturography.

Results:
There were no statistically significant differences on any clinical measure between children with concussion and children without concussion. Younger children without concussion performed significantly worse on several rotary chair and balance measures compared with older children without concussion.

Conclusions:
No vestibular, oculomotor, or balance measures were significantly different between children with concussion and children without concussion, suggesting these measures may not be useful in the evaluation of a child with concussion and vestibular and/or oculomotor symptoms. Future research should investigate age effects and other vestibular and oculomotor tests to identify objective findings that better relate to vestibular and/or ocular symptoms in children with concussion.
Multidimensional Psychoeducative and Counseling Intervention (SAAM) for Symptomatic Patients With Mild Traumatic Brain Injury: A Pilot Randomized Controlled Trial
Authors: Audrit Hélène , Beauchamp Miriam H. , Tinawi Simon , Laguë-Beauvais Maude , Saluja Rajeet , de Guise Elaine 
Published: March 2021

Objective:
To estimate feasibility and explore the treatment effect of a psychoeducative and counseling intervention program targeting 4 postconcussion symptoms (SAAM: Sleep/fatigue, Attention, Anxiety/mood, Memory).

Setting:
Level 1 trauma center.

Participants:
Twenty-five patients with postconcussion symptoms enrolled 1 to 3 months post-accident.

Design:
Parallel-group (experimental and wait-list control), randomized controlled trial, with masked outcome assessment the week following the last intervention session. The Experimental group received the SAAM intervention (1 session/week during 4 weeks); care as usual was maintained for both groups.

Main Measure:
Rivermead Post-concussion Symptoms Questionnaire (RPQ).

Secondary Measures:
Hospital Anxiety and Depression Scale (HADS-A/-D); Pittsburgh Sleep Quality Index (PSQI); Multidimensional Fatigue Inventory (MFI); attention and memory neuropsychological battery; Community Integration Questionnaire (CIQ).

Tolerability Measure:
A 10-item satisfaction questionnaire for the experimental group.

Results:
15.67% of the participants evaluated for eligibility were randomized and completed the evaluation at T0. High rates of satisfaction regarding the SAAM intervention were found in the experimental group (n = 10). One participant (experimental group) withdrew after T0. Exploratory results showed that the group × time interaction was not significant, but had a large effect size for the RPQ (P = .051, η2 = .16) and HADS-D (P = .052, η2 = 0.17), and a significant interaction was found with a large effect size for the PSQI (P = .017, η2 = .24) and MFI (P = .041, η2 = .18). Post-hoc analyses revealed a significant reduction of these variables post-intervention. No significant group × time interaction was observed for cognitive measures and CIQ.

Conclusion:
The pilot study demonstrates the feasibility and tolerability of the SAAM intervention. Preliminary data suggest that SAAM intervention delivered post-acutely might reduce postconcussion symptoms, depression symptoms, fatigue, and sleep difficulties. A larger scale randomized control trial is warranted to confirm these promising results.
Primary Language and Participation Outcomes in Hispanics With Traumatic Brain Injury: A Traumatic Brain Injury Model Systems Study
Authors: Sander Angelle M. , Ketchum Jessica M. , Lequerica Anthony H. , Pappadis Monique R. , Bushnik Tamara , Hammond Flora M. , Sevigny Mitch 
Published: March 2021

Objective:
To examine the relationship between primary language and participation outcomes in English- and Spanish-speaking persons with complicated mild to severe traumatic brain injury (TBI) at 1 year post-injury.

Setting:
Community following discharge from inpatient rehabilitation.

Participants:
A total of 998 Hispanic participants with outcomes available at year 1 follow-up; 492 (49%) indicated English as their primary language and 506 (51%) indicated Spanish as their primary language.

Design:
Prospective, multicenter, cross-sectional, observational cohort study.

Main Measures:
Community participation at 1 year post-injury was assessed by 3 domains of the Participation Assessment with Recombined Tools-Objective (PART-O): Out and About, Productivity, and Social Relations.

Results:
Unadjusted group comparisons showed better participation outcomes for English versus Spanish speakers for all PART-O domains and for the Balanced Total score. After controlling for relevant covariates, English-speaking participants had significantly better PART-O Balanced Total scores and better scores on the Social Relations domain, although effect sizes were small.

Conclusions:
Hispanic persons with TBI whose primary language is Spanish may require greater assistance integrating socially back into their communities after TBI. However, potential cultural differences in value placed on various social activities must be considered. Potential cultural bias inherent in existing measures of participation should be investigated in future studies.
Pharmacological Treatment of Agitation and/or Aggression in Patients With Traumatic Brain Injury: A Systematic Review of Reviews
Authors: Rahmani Elham , Lemelle Tricia M. , Samarbafzadeh Ehsan , Kablinger Anita S. 
Published: March 2021

Objective:
To systematically review the available literature on the pharmacological management of agitation and/or aggression in patients with traumatic brain injury (TBI), synthesize the available data, and provide guidelines.

Design:
Systematic review of systematic reviews.

Main Measures:
A literature review of the following websites was performed looking for systematic reviews on the treatment of agitation and/or aggression among patients with TBI: PubMed, CINAHL, DynaMed, Health Business Elite, and EBSCO (Psychology and behavioral sciences collection). Two researchers independently assessed articles for meeting inclusion/exclusion criteria. Data were extracted on year of publication, reviewed databases, dates of coverage, search limitations, pharmacological agents of interest, and a list of all controlled studies included. The included controlled studies were then examined to determine potential reasons for any difference in recommendations.

Results:
The literature review led to 187 citations and 67 unique publications after removing the duplicates. Following review of the title/abstracts and full texts, a total of 11 systematic reviews were included. The systematic reviews evaluated the evidence for safety and efficacy of the following medications: amantadine, amphetamines, methylphenidate, antiepileptics, atypical and typical antipsychotics, benzodiazepines, β-blockers, and sertraline.

Conclusions:
On the basis of the results of this literature review, the authors recommend avoiding benzodiazepines and haloperidol for treating agitation and/or aggression in the context of TBI. Atypical antipsychotics (olanzapine in particular) can be considered as practical alternatives for the as-needed management of agitation and/or aggression in lieu of benzodiazepines and haloperidol. Amantadine, β-blockers (propranolol and pindolol), antiepileptics, and methylphenidate can be considered for scheduled treatment of agitation and/or aggression in patients with TBI.
Research Letter: PTSD Symptom Severity and Multiple Traumatic Brain Injuries Are Associated With Elevated Memory Complaints in Veterans With Histories of Mild TBI
Authors: Sorg Scott F. , Werhane Madeleine L. , Merritt Victoria C. , Clark Alexandra L. , Holiday Kelsey A. , Hanson Karen L. , Jak Amy J. , Schiehser Dawn M. , Delano-Wood Lisa 
Published: March 2021

Objective:
The evaluation of memory complaints in mild traumatic brain injury (mTBI) remains an important clinical consideration, especially in the context of comorbid psychiatric symptoms such as posttraumatic stress disorder (PTSD). We compared subjective memory complaints in veterans with and without a history of mTBI, examined ratings between those with single versus multiple mTBIs, and investigated associations between memory complaints and PTSD symptom severity.

Methods:
117 outpatient veterans (mTBI: n = 79 [single mTBI: n = 22, multiple mTBI: n = 57], military controls [MCs]: n = 38) completed a TBI history assessment, the Prospective-Retrospective Memory Questionnaire (PRMQ), and the PTSD Checklist–Military Version (PCL-M).

Results:
Hierarchical multiple regression showed that greater PCL-M scores significantly predicted elevated PRMQ-Total scores, accounting for 38% of the variance explained (P < .001). mTBI status predicted an additional 5% of variance in memory complaints (P < .01). The multiple-mTBI group endorsed more memory complaints than either MCs (P < .01) or the single-mTBI group (P < .05), who did not differ from MCs (P > .50).

Conclusions:
Comorbid PTSD symptoms are an important factor when considering memory complaints in veterans with a reported history of mTBI. However, independent of comorbid PTSD symptoms, mTBI status—particularly in the context of repetitive neurotrauma—uniquely contributes to memory complaints. Findings suggest that veterans with a history of multiple mTBIs may be a particularly vulnerable group in need of specialized interventions and/or psychoeducation.
Staff Traumatic Brain Injury Skill Builder: Evaluation of an Online Training Program for Paraprofessional Staff Serving Adults With Moderate-Severe TBI
Authors: Powell Laurie E. , Gau Jeff , Glang Ann , Corrigan John D. , Ramirez Meghan , Slocumb Jody 
Published: March 2021

Objective:
To evaluate the online, self-guided, interactive Staff TBI Skill Builder training program for paraprofessional staff.

Design:
A within-subjects, nonexperimental evaluation involving 79 paraprofessionals and professionals working across a range of settings. Participants completed a pretest (T1), a posttest immediately upon program completion (T2), and follow-up (T3) 60 days after program completion.

Measures:
(1) Knowledge of basic traumatic brain injury facts; (2) knowledge application; (3) self-efficacy in responding to text-based application scenarios; (4) self-report of skill utilization and effectiveness; and (5) program satisfaction (ease-of-use and usefulness).

Results:
Participants demonstrated high levels of knowledge, knowledge application, and self-efficacy at pretest. Despite the high pretest levels, participants showed significant improvements in knowledge application (d = 0.50) after using the program. Nonsignificant gains in knowledge (d = 0.13) and self-efficacy (d = 0.02) were found. The use of selected skills significantly increased from posttest to follow-up. Participants reported high program satisfaction; 99% of the participants indicated that they would recommend the program to others.

Conclusion:
These results demonstrate the feasibility of providing interactive, online training for paraprofessionals serving adults with moderate-severe traumatic brain injury.