bluuebunny/crossref_metadata_2025_split huggingface dataset:
A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain
Authors: Miller Alan , Candido Kenneth D. , Knezevic Nebojsa Nick , Rivera José , Lunseth Paul , Levinson Dennis J. , Formoso Ferdinand , Solanki Daneshvari , Tavel Edward , Krull Angela , Radnovich Richard , Burkhead Daniel , Souza Dmitri , Helm Standiford , Katz Nathaniel , Dworkin Robert H. , Cohen Steven P. , Rathmell James P. , Buvanendran Asokumar , Levin Joshua , Stannard Elizabeth , Ambrose Chris , Jaros Mark , Vought Kip , Lissin Dmitri 
Published: June 2024

Abstract
Epidural steroid injections are used to treat lumbosacral radicular pain. However, there are no Food and Drug Administration–approved corticosteroids for lumbosacral radicular pain and all currently available injectable corticosteroids carry safety warnings about their use in epidural steroid injection procedures. SP-102 (dexamethasone injectable viscous gel) was developed to provide a safer option with extended local effect. In a randomized, double-blind, placebo-controlled, multicenter trial, 401 patients with moderate-to-severe leg pain from unilateral intervertebral lumbar disc herniation were randomized (1:1) to receive transforaminal SP-102 or sham intramuscular (IM) placebo injection and followed for 24 weeks. If clinically warranted, a repeat open-label SP-102 injection was allowed between 4 and 20 weeks for both groups. Primary and key secondary end points were change in average daily pain on the Numeric Pain Rating Scale in the affected leg and disability measured by Oswestry Disability Index over 4 weeks. Other secondary end points included time to repeat injection, pain, and quality of life assessments. Over 4 weeks, SP-102 demonstrated statistically significant pain relief compared with placebo (least-squares mean group difference −0.52 [SE 0.163] [P = 0.002]) in the intent-to-treat population. Oswestry Disability Index mean improvement was −3.38 (1.388) (least-squares mean group difference [SE]) for SP-102 vs placebo (P = 0.015). Median time to repeat injection was 84 days for SP-102 vs 58 days for placebo (P = 0.001). Most other secondary end points were statistically significant for SP-102 compared with placebo. There were no serious adverse events related to study medication or procedure, no adverse events leading to death, and no AEs of special interest (paraplegia, hematoma, or infection).

Trial Registration

ClinicalTrials.gov Identifier: NCT03372161.
Prediction of the response to repetitive transcranial magnetic stimulation of the motor cortex in peripheral neuropathic pain and validation of a new algorithm
Authors: Attal Nadine , Branders Samuel , Pereira Alvaro , Bouhassira Didier 
Published: June 2024

Abstract
Motor cortex repetitive transcranial magnetic stimulation (M1-rTMS) induces analgesic effects in neuropathic pain, but not all patients are good responders, and no clinical predictors of the response have been identified. The present study aimed to develop and validate a simple and easy-to-use predictive algorithm for the individual response to M1-rTMS in peripheral neuropathic pain that may be potentially applicable to any chronic pain condition. This was based on a secondary analysis from a recent double-blind, placebo-controlled trial demonstrating the efficacy of high-frequency M1-rTMS against placebo-rTMS and rTMS of the dorsolateral prefrontal cortex in 149 patients with peripheral neuropathic pain. Baseline variables were entered in the model without preconception, and categorized into sociodemographic, pain, and psychological variables. Good responders to rTMS were defined based on 50% pain relief on average pain intensity (rated on a 0-10 numerical rating scale) at 25 weeks. Ridge regression, feature selection, and Monte Carlo cross-validation were used to build and validate a predictive model specific for the response to M1-rTMS at 25 weeks. The algorithm included 3 variables: 2 were psychological variables (depressive symptoms, magnification dimension of the Pain Catastrophizing Scale) and 1 was related to pain distribution (distal lower extremity pain). It demonstrated 85% sensitivity (P = 0.005) and 84% specificity (P < 0.0001) to predict a good response to M1-rTMS at 25 weeks. It was not predictive of the response to placebo or dorsolateral prefrontal cortex-rTMS. This simple and user-friendly algorithm may contribute to individualize treatment with M1-rTMS in patients with peripheral neuropathic pain in routine and in further clinical trials.

Clinical trial registration:
NCT02010281.
The microbial composition of pancreatic ductal adenocarcinoma: a systematic review of 16S rRNA gene sequencing
Authors: Merali Nabeel , Chouari Tarak , Sweeney Casie , Halle-Smith James , Jessel Maria-Danae , Wang Bing , O’ Brien James , Suyama Satoshi , Jiménez José I. , Roberts Keith J. , Velliou Eirini , Sivakumar Shivan , Rockall Timothy A. , Demirkan Ayse , Pedicord Virginia , Deng Dongmei , Giovannetti Elisa , Annels Nicola E. , Frampton Adam E. 
Published: June 2024

Background:
Pancreatic cancer, specifically pancreatic ductal adenocarcinoma (PDAC), continues to pose a significant clinical and scientific challenge. The most significant finding of recent years is that PDAC tumours harbour their specific microbiome, which differs amongst tumour entities and is distinct from healthy tissue. This review aims to evaluate and summarise all PDAC studies that have used the next-generation technique, 16S rRNA gene amplicon sequencing within each bodily compartment. As well as establishing a causal relationship between PDAC and the microbiome.

Materials and methods:
This systematic review was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. A comprehensive search strategy was designed, and 1727 studies were analysed.

Results:
In total, 38 studies were selected for qualitative analysis and summarised significant PDAC bacterial signatures. Despite the growing amount of data provided, we are not able to state a universal 16S rRNA gene microbial signature that can be used for PDAC screening. This is most certainly due to the heterogeneity of the presentation of results, lack of available datasets, and the intrinsic selection bias between studies.

Conclusion:
Several key studies have begun to shed light on causality and the influence the microbiome constituents and their produced metabolites could play in tumorigenesis and influencing outcomes. The challenge in this field is to shape the available microbial data into targetable signatures. Making sequenced data readily available is critical, coupled with the coordinated standardisation of data and the need for consensus guidelines in studies investigating the microbiome in PDAC.
Gender disparities in high-quality dermatology research over the past 15 years
Authors: Zlakishvili Barak , Horev Amir 
Published: June 2024

Background:
In the last 15 years, an increase in U.S. female dermatologists from 41 to 52.2% and a surge in female authorship (FAP) have been noted. Authorship is a pivotal objective measurement of academic productivity and, contribution as first or senior author, plays a major role in the promotion process of active physicians and faculty members.

Objective:
To validate, analyze, and clarify trends in FAP in high-quality dermatology research in the last 15 years.

Methods:
The Thomson Reuters Web of Science Journal Citation Reports 2021 was used to retrieve the 100 most-cited original articles from the top 5 dermatology journals (determined by 2021 impact factors) in 5 consecutive 3-year intervals between 2009 and 2023. Gender application programming interface, a gender algorithm, was used to identify FAP according to country of origin and first name. Monotonic trend test significance level was set at 5%.

Results:
In total, 14,187 articles were retrieved and subdivided into the 100 most-cited in 3-year intervals. A total of 418 first and 447 senior authors' gender were identified. FAP was found in 43%, 31%, and 37% of the first, last, and total authors. Trend analysis revealed a decrease in the last 15 years (S = −4610, P = .068) in senior FAP. Similarly, the trend persists in the United States (S = −1606, P = .052).

Limitations:
Due to the usage of a binary gender identification algorithm, Nonbinary gender could not be identified in this analysis.

Conclusion:
The last 15 years show an inverse relationship, with an increase in female dermatologists and a decrease in senior FAP in high-quality journals in the general dermatology community.
Meta-analysis of combined azithromycin and inhaled budesonide treatment for Chinese pediatric patients with mycoplasma pneumonia
Authors: Zhao Jing , Pan Xiaojing , Shao Peng 
Published: June 2024

Background:
Budesonide, capable of reducing vascular permeability, suppressing mucus secretion, and alleviating edema and spasms, is widely used in China for combined infectious disease treatment. This study assesses budesonide’s efficacy and safety as an adjunct to azithromycin in pediatric Mycoplasma pneumonia management in China, aiming to establish a strong theoretical foundation for its clinical application.

Methods:
We conducted a comprehensive search for qualifying studies across 5 English databases and 4 Chinese databases, covering publications until October 31, 2023. Endpoint analyses were performed using standard software (Stata Corporation, College Station, TX). This study was conducted in compliance with the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Results:
A total of 24 randomized controlled trials were involved in the current study, including 2034 patients. Our findings indicate that the combination of budesonide with azithromycin for the treatment of pediatric Mycoplasma pneumonia delivers superior therapeutic efficacy (Intravenous: odds ratio [OR], 0.156, P < .001; Sequential: OR, 0.163, P = .001; Oral: OR, 0.139, P < .001), improved pulmonary function (Forced expiratory volume in 1 second: weighted mean differences [WMD], −0.28, P = .001; Peak expiratory flow: WMD, −0.554, P = .002; Forced vital capacity: WMD, −0.321, P < .001), diminished lung inflammation (IL-6: WMD, 4.760, P = .002; c-reactive protein: WMD, 5.520, P < .001; TNF-α: WMD, 9.124, P < .001), reduced duration of fever, faster resolution of cough and rales, all without increasing the occurrence of adverse events.

Conclusion:
The combination of budesonide and azithromycin demonstrates enhanced therapeutic effectiveness, promotes improved pulmonary function, shortens the duration of symptoms, and effectively mitigates the overexpression of inflammatory factors like c-reactive protein, TNF-α, and IL-6, all without an associated increase in adverse reactions in pediatric mycoplasma pneumonia.
Centering marginalized voices in advocacy for equitable policy change in kidney disease
Authors: Rizzolo Katherine , Rockey Nathan , Cervantes Lilia 
Published: June 2024

Purpose of review
Inequities in kidney disease are a result of differences in healthcare access and inequitable structural policies that lead to downstream social challenges. An individual with kidney disease sits at the intersection of a variety of governmental and institutional policies that directly affect their access to kidney healthcare and different care delivery models. However, their voice in policy change is often neglected by stakeholders with more structural power. Marginalized individuals with kidney disease are disproportionately affected by kidney disease and inequitable policies can further these health disparities. The review aims to describe how marginalized individuals can be centered in research and lead in advocacy efforts to promote equitable policy change.

Recent findings
The marginalized patient voice is critical in advocacy to promote equitable policy change. We discuss examples illustrating research and advocacy methods which center and partner with marginalized communities to catalyze effective policy interventions.

Summary
Centralizing the patient voice when engaging in advocacy can identify and contextualize the effects of inequitable public policy and improve advocacy efforts.
Optimizing Quality Improvement Methods in Practice
Authors: Reynolds Staci S. , Waldrop Julee B. 
Published: June 2024

Background:
Quality improvement (QI) initiatives help ensure patients are receiving high-quality care. Iterative Plan-Do-Study-Act (PDSA) cycles are used to test change. Data are evaluated over time, and tests of change can be modified or discarded as needed.

Problem:
Health care QI teams lack the flexibility to conduct PDSA cycles, often conducting pre/post quasi-experimental research studies instead.

Approach:
This article reviews a case study of a “personal improvement” initiative as an example of QI methods and data evaluation for an individual trying to lose weight. The purpose of this article is to provide guidance on best practices for conducting QI initiatives; common pitfalls that clinicians may face when leading their own QI initiatives are identified and recommendations to overcome these challenges are discussed.

Conclusions:
Concepts from this case study, along with supplemental resources provided, can help clinicians optimize QI methodologies in the health care setting.
Evaluation of a Cardiovascular Disease/Diabetes Mellitus Expansion Program for Community Health Workers Employed by Rhode Island Community Health Teams
Authors: McAtee Cali M. , Baker Justan T. , DeWolf Breanne M. , Sheridan Megan N. , George Elise M. , Sutton Nancy A. 
Published: June 2024

Context:
The integration of certified community health workers (CCHWs) with specialty chronic disease training into clinical care teams has demonstrated improvements in chronic disease quality of care, management, and outcomes.

Program:
Rhode Island Department of Health’s Diabetes, Heart Disease, and Stroke Program expanded the roles of CCHWs employed by Community Health Teams for chronic disease with a focus on cardiovascular disease (CVD) and diabetes mellitus (DM) from 2020 to 2023. Rhode Island Department of Health’s Diabetes, Heart Disease, and Stroke Program sought to determine whether patient health behaviors and clinical outcomes improved with specialty trained CCHW support.

Implementation:
Community Health Teams identified high-risk or rising-risk patients with hypertension, high cholesterol, and/or diabetes. During an infrastructure phase, patients were assigned a CCHW who had not received CVD/DM specialty training. During a performance phase, a separate cohort of patients was assigned a CVD/DM specialty-trained CCHW. In each phase, patients were seen by the CCHWs at least twice and completed baseline and follow-up health assessments. The trained CCHWs utilized the baseline assessment to offer health coaching specific to the patient’s chronic disease–related needs.

Evaluation:
Improvements in blood pressure readings and cholesterol were observed at an individual level for CVD patients. However, a significant difference was not observed for hypertension or high cholesterol when comparing phases. Individual-level results indicated improved HbA1c values for DM patients; however, the differences in clinical values were not significant. Although there were no significant differences for clinical values between the phases, the proportion of patients who reported confidence in managing their condition(s) increased from baseline to follow-up for both phases.

Discussion:
It cannot be concluded that specialty-trained CCHWs have significant impact on patient behaviors and clinical outcomes. However, overall CCHW intervention did result in improved self-efficacy in patients to manage their chronic conditions. Further evaluation is needed to understand what factors led to improved patient confidence levels.
Virtual Expansion of the YMCA's Blood Pressure Self-Monitoring (BPSM) Program: Using Telehealth to Adapt an Evidence-Based Program to Reach Rural Communities in South Carolina
Authors: Grant Brittney , Myers Kristian , Patterson Halie , Suthar Ishan , Garst Kaylin , James Michele , Tucker Chet 
Published: June 2024

Context:
Disparities in cardiovascular disease prevalence and death exist among South Carolina's rural residents. Blood pressure self-monitoring (BPSM), where individuals measure their own blood pressure outside of the clinical environment, coupled with additional support, is an evidence-based, cost-effective strategy that is underutilized at large.

Program:
The YMCA's BPSM program is an evidence-based, 4-month program that includes 2 individualized office hours with a Healthy Heart Ambassador and 4 nutrition education sessions per month. Participants are provided with a blood pressure cuff and notebook to track their blood pressure at home in between sessions.

Implementation:
The SC Department of Health and Environmental Control partnered with the SC Alliance of YMCAs to expand the YMCA's BPSM program virtually. The traditional program was adapted to allow for virtual participant encounters. To target rural communities, partnerships were leveraged or established with rural health centers, federally qualified health centers, free medical clinics, and other state health department regions for participant referrals into the program.

Evaluation:
A developmental evaluation design was utilized to monitor the virtual adaptation of the YMCA's BPSM program from April 2021 to May 2023. At the end of the project, 10 referral sources were identified to refer participants to the program. In total, 253 participants were referred to the program, 126 participants enrolled into the program, and 52 participants completed the program. Completers of the virtual program were successful in improving their blood pressure.

Discussion:
Successes of the virtual program were not without challenges. Lessons learned from the virtual expansion of this program included ensuring participants' readiness to engage in a 4-month program, assessing participants' digital literacy, and considering broadband access in rural areas. Improvements in blood pressure and the program's reach demonstrate merit in continuing to scale the virtual adaptation of this program; however, contextual and structural factors should be considered.
Preparing to Address Social Determinants of Health (SDOH): Approaches to Clinic Transformation
Authors: Liu Xinran , Boak Brandi , Eggleston Molly , Rodi Andrea , Biscardi Ashley , Elias Thistle 
Published: June 2024

Context:
Pennsylvanians' health is influenced by numerous social determinants of health (SDOH). Integrating SDOH data into electronic health records (EHRs) is critical to identifying health disparities, informing public health policies, and devising interventions. Nevertheless, challenges remain in its implementation within clinical settings. In 2018, the Pennsylvania Department of Health (PADOH) received the Centers for Disease Control and Prevention's DP18-1815 “Improving the Health of Americans Through Prevention and Management of Diabetes and Heart Disease and Stroke” grant to strengthen SDOH data integration in Pennsylvania practices.

Implementation:
Quality Insights was contracted by PADOH to provide training tailored to each practice's readiness, an International Classification of Diseases, Tenth Revision (ICD-10) guide for SDOH, Continuing Medical Education on SDOH topics, and introduced the PRAPARE toolkit to streamline SDOH data integration and address disparities. Dissemination efforts included a podcast highlighting success stories and lessons learned from practices. From 2019 to 2022, Quality Insights and the University of Pittsburgh Evaluation Institute for Public Health (Pitt evaluation team) executed a mixed-methods evaluation.

Findings:
During 2019-2022, Quality Insights supported 100 Pennsylvania practices in integrating SDOH data into EHR systems. Before COVID-19, 82.8% actively collected SDOH data, predominantly using PRAPARE tool (62.7%) and SDOH ICD-10 codes (80.4%). Amidst COVID-19, these statistics shifted to 65.1%, 45.2%, and 42.7%, respectively. Notably, the pandemic highlighted the importance of SDOH assessment and catalyzed some practices' utilization of SDOH data. Progress was evident among practices, with additional contribution to other DP18-1815 objectives. The main challenge was the variable understanding, utilization, and capability of handling SDOH data across practices. Effective strategies involved adaptable EHR systems, persistent efforts by Quality Insights, and the presence of change champions within practices.

Discussion:
The COVID-19 pandemic strained staffing in many practices, impeding SDOH data integration into EHRs. Addressing the diverse understanding and use of SDOH data requires standardized training and procedures. Customized support and sustained engagement by facilitating organizations are paramount in ensuring practices' efficient SDOH data collection and integration.
Outcome Evaluation of a Public Health Intervention on Cardiovascular Disease (CVD) Prevention Among Women Aged 40-64 with Low Incomes in Nebraska
Authors: Daniels Jianping , Leypoldt Melissa , Dillon Cathy , Sweazy Aaron , Crane Jill 
Published: June 2024

Objectives:
To evaluate the effectiveness of the program interventions on cardiovascular disease in Nebraska women who are low income and have no health insurance.

Design:
This evaluation used pre- and post-comparison approach. Paired t test and McNemar’s test were used to examine the changes after the program interventions.

Participants:
Nebraska women aged 40 to 64 years, without health insurance, and with household incomes up to 225% Federal Poverty Level.

Setting and Intervention:
A network of community–clinical linkages in which medical providers provided preventive screening services and risk reduction counseling in clinical settings and community health workers provided lifestyle interventions in community settings either over the phone or in person.

Main Outcome Measure:
The data included weight, blood pressure measures, self-blood pressure monitoring and management, total cholesterol, fasting glucose or A1C, smoking status, nutrition, and physical activities.

Results:
Among 2649 participants, 82.2% were overweight, 50.3% had hypertension, 52.7% had high cholesterol, 20.7% had diabetes, 22.5% were current smokers, and 56.4% had more than 1 risk factor. A total of 1312 participants (57.3%) participated in at least 1 lifestyle intervention session, and among them, 65.8% completed at least 3 sessions. Paired t test and McNemar’s test indicated significant improvement in hypertension control and self-management; a significant amount of weight loss with 24.1% losing at least 5 pounds; and an increase in healthy eating and physical activity.

Conclusions:
These participants benefited from the Nebraska program. Utilizing a statewide clinical network and participating in lifestyle interventions through local health departments, participants improved some chronic health conditions and decreased their risks of developing cardiovascular diseases.