bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans
Authors: Yu Qilu , George Steven Z , Kyriakides Tassos C , Rhon Daniel I , Morasco Benjamin J , Dziura James , Fritz Julie M , Geda Mary , Peduzzi Peter , Long Cynthia R 
Published: November 2024

Abstract

Background
Best practices for clinical trials stipulate that statistical analysis plans (SAPs) need to be finalized before initiation of any analysis. However, there is limited guidance about when changes to SAPs are acceptable and how these changes should be incorporated into the research plan with appropriate documentation.

Methods
We conducted a survey of 12 pragmatic clinical trials (PCTs) in the Pain Management Collaboratory that evaluated nonpharmacological interventions for pain to assess the following SAP information: (1) location of statistical analysis details, (2) types of statistical analyses planned, (3) sponsor requirements, (4) templates used for development, (5) publication plan, (6) changes since trial launch, (7) process of documenting changes, and (8) process of updating the trial registry.

Results
All 12 PCTs provided details of their SAPs for the primary outcomes in the institutional review board–approved trial protocol; 8 included plans for secondary outcomes, and 6 included plans for tertiary/exploratory outcomes. Most PCTs made SAP changes after trial initiation, many as a result of COVID-19–related issues. Eleven of the PCTs were actively recruiting participants. Changes were made to sample size, study design, study arms, and analytical methods, all before the data lock/unblinding. In all cases, justification for the changes was documented in the trial protocol or SAP, signed off by the trial biostatistician and principal investigator, and reviewed/approved by an institutional review board, data and safety monitoring board, or sponsor.

Conclusions
We recommend that SAP changes can be acceptable up to the time of data lock/unblinding. To maintain full transparency and necessary rigor, clear documentation of such changes should include details, rationale, date(s) such changes were implemented, and evidence of approval by relevant oversight bodies.
Utility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory
Authors: Peduzzi Peter , Brandt Cynthia , Dearth Christopher L , Dziura James , Farrokhi Shawn , George Steven Z , Kyriakides Tassos C , Long Cynthia R , Mascha Edward J , Patterson Charity G , Rhon Daniel I , Kerns Robert D 
Published: November 2024

Abstract

Objective
Despite careful design of clinical trials, unforeseen disruptions can arise. The PICOTS (Patient population, Intervention, Comparator, Outcomes, Timepoints, Setting) framework was used to assess disruptions in pain management research imposed by coronavirus disease 2019 (COVID-19) within the Pain Management Collaboratory.

Methods
Rapid qualitative methods were employed to identify trial disruptions due to COVID-19 in 11 pragmatic clinical trials of nonpharmacological approaches for pain management. The PICOTS framework was applied by investigators of 4 Collaboratory trials selected to cover 4 types of trial designs (individually randomized, stepped-wedge, cluster, sequential multiple assignment randomized trial—SMART). Interviews with the lead investigators of these trials were completed, and findings were presented/discussed on video calls over a 6-month period (March-August 2021) from which themes/lessons learned were identified and consensus reached.

Results
Investigators indicated that patient populations remained generally stable. A major COVID-19 trial disruption was moving from in-person to virtual care affecting delivery of interventions/comparators and outcome assessments. The resultant mixed-mode of care delivery created issues with intervention fidelity posing analytic challenges. COVID-19 also induced ongoing/intermittent delays and other barriers to accessing primary and specialty care at some facilities, creating research capacity issues affecting delivery of experimental interventions requiring sustained, reliable participation of clinical partners. Study designs most affected by COVID-19 were stepped-wedge (intervention/comparator changing over time), cluster (increased site variability inflating intracluster correlation), and SMART (second-stage randomizations disrupted); stratified individually-randomized trials were less vulnerable because of individual-level randomization.

Conclusions
PICOTS provides a framework for assessing the impact of trial disruptions in a structured manner. Given the COVID-19 experience, it is important for researchers to consider the potential impact of future trial disruptions during study planning.
Energy metabolism dysregulation, cerebrovascular aging, and time-restricted eating: Current evidence and proof-of-concept findings
Authors: da C Pinaffi-Langley Ana Clara , Pinto Camila B , Mukli Peter , Peterfi Anna , Kaposzta Zalan , Owens Cameron D , Szarvas Zsofia , Muranyi Mihaly , Adams Cheryl , Shahriari Ali , Balasubramanian Priya , Ungvari Zoltan , Csiszar Anna , Conley Shannon , Hord Norman G , Anderson Leah , Tarantini Stefano , Yabluchanskiy Andriy 
Published: November 2024

Abstract
Dysregulated energy metabolism is a hallmark of aging, including brain aging; thus, strategies to restore normal metabolic regulation are at the forefront of aging research. Intermittent fasting, particularly time-restricted eating (TRE), is one of these strategies. Despite its well-established effectiveness in improving metabolic outcomes in older adults, the effect of TRE on preserving or improving cerebrovascular health during aging remains underexplored. We explored how aging itself affects energy metabolism and contextualized these age-related changes to cerebrovascular health. We also conducted a literature search on PubMed and Scopus to identify and summarize current studies on TRE in older adults. Finally, we provided preliminary data from our proof-of-concept pilot trial on the effect of 6-month TRE on cerebrovascular health in older adults. Current evidence shows the potential of TRE to improve energy metabolism and physiological outcomes in older adults. TRE may improve cerebrovascular function indirectly due to its effect on glucose homeostasis. However, to date, direct evidence of the effect of TRE on cerebrovascular parameters is lacking. TRE is a well-tolerated and promising dietary intervention for promoting and maintaining cerebrovascular health in older adults. Further studies on TRE in older adults must be better controlled for energy balance to elucidate its independent effects from those of caloric restriction.
Policing, Technology, and Public Values: A Public Administration Research Agenda
Authors: Feeney Mary K , Mughan Sian 
Published: November 2024

ABSTRACT
There is a great deal of research investigating how technologies produce efficiencies for police departments. Criminal justice research often focuses on a single technology and from a single perspective—the police—noting how technologies increase efficiency and efficacy for police departments. Researchers in science and technology studies also investigate how police departments adopt and use technology, but typically focus on the tensions between technologies and society, including potential threats to individual and community privacy and rights. Public administration scholars tend to center their policing research on the tensions between police missions and behavior and the advancement of citizen rights, including privacy, social equity, and fairness, with little to no focus on theories of technology adoption and use. We bring together these three literatures on technology, policing, and public values to investigate how three key stakeholders—the administrative state, the police, and citizens—use technology in the context of policing to achieve public values. We argue public values shape technology adoption and use, and stakeholders use technologies to achieve specific public values. This interactive process is key to understanding technology in policing and variation in the achievement of public value outcomes. We develop a framework for assessing how technology is used in policing to advance public values from the perspectives of multiple stakeholders, applying it to the cases of body-worn cameras and predictive policing.
Mother–child closeness and adolescent structural neural networks: a prospective longitudinal study of low-income families
Authors: Hong Sunghyun H , Hardi Felicia A , Tillem Scott , Goetschius Leigh G , Brooks-Gunn Jeanne , McLoyd Vonnie , Lopez-Duran Nestor L , Mitchell Colter , Hyde Luke W , Monk Christopher S 
Published: November 2024

Abstract
Mother–child closeness, a mutually trusting and affectionate bond, is an important factor in shaping positive youth development. However, little is known about the neural pathways through which mother–child closeness is related to brain organization. Utilizing a longitudinal sample primarily from low-income families (N = 181; 76% African American youth and 54% female), this study investigated the associations between mother–child closeness at ages 9 and 15 years and structural connectivity organization (network integration, robustness, and segregation) at age 15 years. The assessment of mother–child closeness included perspectives from both mother and child. The results revealed that greater mother–child closeness is linked with increased global efficiency and transitivity, but not with modularity. Specifically, both the mother’s and child’s reports of closeness at age 15 years predicted network metrics, but report at age 9 years did not. Our findings suggest that mother–child closeness is associated with neural white matter organization, as adolescents who experienced greater mother–child closeness displayed topological properties indicative of more integrated and robust structural networks.
Relationship between Burnout and Type A Behavior Pattern in Spanish Social Workers
Authors: Ariza Toledano Leonor Belén , Ruiz-Olivares Rosario 
Published: November 2024

Abstract
The aims of this study were to establish the prevalence of burnout and type A behavior pattern (TABP) among social workers in Spain and to examine their relationship with sociodemographic variables in a sample of 442 members of professional social workers’ associations in Spain. The Spanish version of the Jenkins Activity Survey, form H (JASE-H) and the Maslach Burnout Inventory were used as instruments to measure TABP and burnout, respectively. Bivariate correlation test, analysis of variance, and logistic regression were carried out to analyze the data. The results showed that variables associated with TABP (competitiveness, hostility, impatience, and workload) increase the risk of burnout, with hostility and workload being identified as predictive risk factors. Gender differences impacted burnout, with women experiencing greater emotional exhaustion, while age and time in the job influenced type A behavior, with older age associated with heightened hostility and decreased workload, and longer time in the job linked to reduced competitiveness. Conducting this study was crucial to determine whether there are aspects of TABP that impact the development of burnout, in order to design interventions and prevention strategies that promote the health and well-being of affected individuals.
Trust declarations and creditor protection in insolvency: lessons from Wade & Anor v Singh & Ors
Authors: Mak Charles Ho Wang 
Published: November 2024

Abstract
The High Court case Amanda Wade and Nicholas Nicholson (Joint Liquidators of MSD Cash and Carry Plc (In Liquidation)) v Mohinder Singh, Surjit Singh Deol, Raminder Kaur Deol, the Estate of Bakshish Kaur (Deceased) (‘Wade & Anor v Singh & Ors’) examined the validity of a Declaration of Trust and enforcement of charging orders in a corporate insolvency. Involving a property owned by family members of a liquidated company, the case explored the intersection of trust law, property rights, and creditor protection. The court invalidated the Declaration as an attempt to defraud creditors under the Insolvency Act 1986. This case emphasises the importance of clear intent in trust declarations and reinforces creditor rights protection in insolvency proceedings. The case underscores the need for specialist legal advice in property and trust matters, particularly when creditor claims may arise.
Evidence-Informed Nursing Clinical Practices for Wound Debridement
Authors: Rajhathy Erin M. , Hill Mary C. , Tran David Le , Sibbald R. Gary , Ayello Elizabeth A. 
Published: November 2024

ABSTRACT
Debridement, a mainstay of nursing clinical practice, refers to the removal of dead or unhealthy tissue from a wound to facilitate healing. Debridement is one component of the concept of wound bed preparation that has long guided the approach to wound management. The ability of a wound to heal must be determined prior to the initiation of any method of debridement. In areas where high-quality, comparative studies on the relative benefits of different debridement modalities are lacking, nurses should adopt an evidence-informed approach to care. To do this, nurses must understand the importance of following a comprehensive, holistic approach when treating chronic wounds. Nurses should have knowledge of inflammation and infection control and of the fundamentals of moisture management, recognize the need for debridement in healable wounds, and be familiar with different debridement options. This article provides nurses with a wound management framework, an overview of wound debridement options based on the potential for wound healing, and scope of practice considerations for developing a plan of care. A composite case is presented to illustrate the critical considerations in wound care.
Importance of Modifiable Factors to Infant Health in the Context of Prenatal Opioid Use Disorder
Authors: Ehrenthal Deborah B. , Wang Yi , Kirby Russell S. 
Published: November 2024

ObjectiveThe aim of the study is to estimate the contributions of common and modifiable risk factors to birth outcomes of individuals with prenatal opioid use disorder (OUD).MethodsWe conducted an observational cohort study of all Wisconsin Medicaid-covered singleton live births from 2011–2019. Using Blinder-Oaxaca decomposition for continuous, and the Fairlie extension for categorical outcomes, we estimated the contributions of comorbidities, tobacco use, pre-pregnancy body mass index (BMI), and gestational weight gain (GWG) to birthweight for gestational age (BW-GA) percentile associated with prenatal OUD and the risk of small for gestational age (SGA), net of other factors.ResultsAmong 216,684 births, the 5184 (2.4%) with OUD had greater prevalence of tobacco use, a lower average pre-pregnancy BMI (26.7 kg/m2, SD = 0.09 versus 28.4 kg/m2, SD = 0.02), and on average 2.0 pounds less GWG, when compared to those without OUD. The predicted mean BW-GA percentile among infants with OUD exposure was 11.2 (95% CI 10.5, 11.9) points lower than those without; 62.3% (95% CI 57.4, 67.1) of this difference could be explained by the variables included in the full model and the largest contribution of the explained portion came from the higher prevalence of tobacco use followed by the contributions of comorbidities, GWG, and pre-pregnancy BMI.ConclusionsMore than half of the difference in BW-GA percentile, and risk of SGA associated with prenatal OUD, could be attributed to modifiable factors and not opioids. Moreover, potentially modifiable factors including tobacco use and measures reflecting nutritional status contributed to a majority of the explained portion.
Racial and Ethnic Disparities in Referral Rejection from Postacute Care Facilities among People with Opioid Use Disorder in Massachusetts
Authors: Rosenmoss Sophie , LaRochelle Marc , Bearnot Benjamin , Weinstein Zoe , So-Armah Kaku , Moyo Patience , Yan Shapei , Walley Alexander Y. , Kimmel Simeon D. 
Published: November 2024

Objectives
The aim of the study was to examine the association between Black, White, and Hispanic or Latino race and ethnicity and referral rejection from private postacute care facilities among hospitalized individuals with opioid use disorder (OUD).

Methods
In this retrospective cohort study, we linked electronic postacute care referrals from Boston Medical Center in 2018 to electronic medical record data, which we used to ascertain OUD status and race and ethnicity. Using multivariable logistic regression, we examined the association between Black, White, and Hispanic or Latino race and ethnicity and referral rejection, adjusting for individual-level characteristics including medication for opioid use disorder treatment type and for facility-level factors using facility random effects.

Results
We identified 159 hospitalizations from 141 individuals with OUD referred to private postacute medical care, corresponding to 1272 referrals to 244 facilities. Hospitalizations comprised 53 (33%) non-Hispanic Black, 28 (18%) Hispanic or Latino, and 78 (49%) non-Hispanic White individuals. In adjusted analyses, referrals for non-Hispanic Black individuals had significantly higher odds of rejection compared to referrals for non-Hispanic White individuals (adjusted odds ratio 1.83, 95% confidence interval [1.24, 2.69], P = 0.002). There were no significant differences between referrals for Hispanic or Latino individuals and non-Hispanic White individuals (adjusted odds ratio 1.11, 95% confidence interval [0.67, 1.84], P = 0.69).

Conclusions
Among people with OUD referred to private postacute care in Massachusetts, non-Hispanic Black individuals were more likely to be rejected compared to non-Hispanic White individuals, demonstrating racism in postacute care admissions. Efforts to address discrimination against people with OUD in postacute care admissions must also address racial equity.
Xylazine Positivity in Opioid-Positive Drug Screens on an Inpatient Labor Unit
Authors: Trammel Cassandra , Azimi Vahid , Crews Bridgit , Roper Stephen , Raghuraman Nandini , Carter Ebony B. , Frolova Antonina , Odibo Anthony O. , Lawlor Megan , Kelly Jeannie C. 
Published: November 2024

Abstract

Objective
Untreated opioid use disorder (OUD) is associated with significant morbidity in pregnancy. Recent reports have highlighted the rise of xylazine in the nonprescribed fentanyl supply. The frequency with which pregnant people with OUD are exposed to xylazine has not been characterized. We sought to describe the rate of xylazine detection in urine drug screens (UDS) from pregnant people admitted to a labor unit.

Methods
We performed a cross sectional study of all UDS results from an inpatient obstetric unit at an urban tertiary care center from December 2022, when xylazine was added to the detection panel, through July 2023. We perform universal verbal drug screening, with subsequent urine drug screening only performed after a positive verbal screen and consent. The trend of opioid-positive urine drug screens also positive for xylazine from December to July was measured with the Cochran-Armitage test.

Results
Of 5662 people admitted to Labor and Delivery during the study period, 138 UDS were sent for 123 unique individuals. Ninety-eight (71%) of UDS were positive for nonprescribed substances. Of positive UDS, 36 (37%) were positive for nonprescribed opioids, and of these, 17 (47.2%) were positive for xylazine among 14 pregnant people. The trend of UDS positive for opioids that were also positive for xylazine increased significantly over time (P = 0.030), from 0% in December 2022 to 100% in July 2023.

Conclusions
Over 8 months, xylazine positivity significantly increased in UDSs positive for nonprescribed opioids in an urban Midwestern hospital. These results underscore the critical need to study the impact of xylazine on obstetric outcomes.
Associations Between Sleep Health and Child Behavior at Age 6 Years in the INSIGHT Study
Authors: Dadzie Adwoa , Master Lindsay , Hohman Emily E. , Acton Erika Hernandez , Tauriello Sara , Paul Ian M. , Savage Jennifer S. , Anzman-Frasca Stephanie , Buxton Orfeu M. 
Published: November 2024

ABSTRACT

Objective:
Suboptimal sleep is associated with disruptive behaviors in childhood. We evaluate associations of mean and variability (SD) of sleep duration, quality, and timing with emotion regulation, impulsivity, and prosocial and antisocial behavior in children.

Methods:
Intervention Nurses Start Infants Growing on Healthy Trajectories, a randomized controlled trial designed for obesity prevention, compared a responsive parenting intervention delivered in the first 2.5 years after birth with a home safety control group. At age 6 years, children wore an actigraphy device for 7 days and participated in behavioral tasks evaluating behavioral control, emotion regulation, and prosocial and antisocial behaviors. Separate linear regression models examined associations between sleep and behavioral variables, adjusting for study group, child sex, and household income. Moderation analysis investigated whether the study group moderated relationships between sleep and positive age-appropriate behavior.

Results:
Children (N = 143, age 6.7 ± 0.3 years) were predominantly non-Hispanic White (95%). Mean actigraphic sleep duration, quality, and timing were not associated with behavioral variables. By contrast, greater variability in sleep onset timing was associated with greater impulsivity (B = 0.85, p = 0.004) and poorer emotion regulation (B = −0.65, p = 0.01). Greater variability in sleep midpoint timing was associated with greater impulsivity (B = 0.80, p = 0.03). The study group moderated the effect of sleep onset variability on behavior; only the home safety control group exhibited a significant negative relationship between variability in sleep onset timing and emotion regulation (B = −1.28, p = 0.0002).

Conclusion:
Findings support the importance of consistency in sleep timing and how this may play a greater role in children's behavioral and emotional outcomes than mean actigraphic sleep duration and quality.
Access to maternity care: challenges and solutions for improving equity across US communities
Authors: Kozhimannil Katy B. , Interrante Julia D. , McGregor Alecia J. 
Published: November 2024

Purpose of review
Improving maternal health is a clinical and policy priority in the United States. We reviewed recent literature on access to maternity care and impacts on racial and geographic equity.

Recent findings
New research indicates a wide range of consequences of obstetric unit closures, as well as health challenges for lower-volume obstetric units and those who travel long distances to care.

Summary
As maternal mortality rates rise, maternity care access is declining in the US, especially in rural areas and communities with a higher proportion of Black, Latinx, or Indigenous residents. Lack of resources and financial strain are challenges for low-volume and Black-serving obstetric units, and targeted investments may help improve safety and access.