Efficacy and Safety of Hyperbaric Oxygen Therapy in Fistulizing Crohn's Disease: A Systematic Review and Meta-analysis.

Background: Hyperbaric oxygen therapy (HBOT) delivers 100% oxygen in a pressurized chamber, increasing tissue oxygen levels and regulating inflammatory pathways. Mounting evidence suggests that HBOT may be effective for inflammatory bowel disease. Our systematic review and meta-analysis aimed to quantify the efficacy and safety of HBOT in fistulizing Crohn's disease (CD).

Experiences of stigma, psychological distress, and facilitative coping among pregnant people with gestational diabetes mellitus.

Background: Gestational diabetes mellitus (GDM) has been rising in the United States, and it poses significant health risks to pregnant individuals and their infants. Prior research has shown that individuals with GDM also experience prevalent stress and mental health issues, which can further contribute to glucose regulation difficulties. Stigma associated with GDM may contribute to these mental health challenges, yet there is a lack of focused research on GDM-related stigma, its impact on psychological health, and effective coping mechanisms.

Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date.

Extending the vision of adaptive point-of-care platform trials to improve targeted use of drug therapy regimens: An agile approach in the learning healthcare system toolkit.

Objectives: Improving the targeted use of drug regimens requires robust real-world evidence (RWE) to address the uncertainties that remain regarding their real-world performance following market entry. However, challenges in the current state of RWE production limit its impact on clinical decisions, as well as its operational scalability and sustainability. We propose an adaptive point-of-care (APoC) platform trial as an approach to RWE production that improves both clinical and operational efficiencies.

An open natural language processing (NLP) framework for EHR-based clinical research: a case demonstration using the National COVID Cohort Collaborative (N3C).

Despite recent methodology advancements in clinical natural language processing (NLP), the adoption of clinical NLP models within the translational research community remains hindered by process heterogeneity and human factor variations. Concurrently, these factors also dramatically increase the difficulty in developing NLP models in multi-site settings, which is necessary for algorithm robustness and generalizability. Here, we reported on our experience developing an NLP solution for Coronavirus Disease 2019 (COVID-19) signs and symptom extraction in an open NLP framework from a subset of sites participating in the National COVID Cohort (N3C).

Association of Depressive Symptom Trajectory With Physical Activity Collected by mHealth Devices in the Electronic Framingham Heart Study: Cohort Study.

Background: Few studies have examined the association between depressive symptom trajectories and physical activity collected by mobile health (mHealth) devices.

Objective: We aimed to investigate if antecedent depressive symptom trajectories predict subsequent physical activity among participants in the electronic Framingham Heart Study (eFHS).

Methods: We performed group-based multi-trajectory modeling to construct depressive symptom trajectory groups using both depressive symptoms (Center for Epidemiological Studies-Depression [CES-D] scores) and antidepressant medication use in eFHS participants who attended 3 Framingham Heart Study research exams over 14 years.

Rapid Whole-Genomic Sequencing and a Targeted Neonatal Gene Panel in Infants With a Suspected Genetic Disorder.

Importance: Genomic testing in infancy guides medical decisions and can improve health outcomes. However, it is unclear whether genomic sequencing or a targeted neonatal gene-sequencing test provides comparable molecular diagnostic yields and times to return of results.

Objective: To compare outcomes of genomic sequencing with those of a targeted neonatal gene-sequencing test.

Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities.

The impact of external reference pricing on pharmaceutical costs and market dynamics.

Growth in the cost of prescription drugs in the US has generated significant interest in the use of external reference pricing (ERP) to tie prices paid for drugs to those in other countries. We used data from the Pricentric ONE™ database, an international drug pricing database, to examine product launch timing, launch price, and price changes from January 2010 - October 2021 in both ERP and non-ERP settings, with a focus on 100 high-priced drugs of interest to Medicare and Medicaid. We found that ERP policies were associated with a 73% reduction in the likelihood of drug launch within 9 months of regulatory approval relative to non-ERP settings.

Cardiac Cachexia in Left Ventricular Assist Device Recipients and the Implications of Weight Gain Early After Implantation.

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.

Association of Longitudinal B-Type Natriuretic Peptide Monitoring With Kidney Failure in Patients With CKD: A Cohort Study.

Rationale & Objective: Both hypervolemia and hypovolemia are associated with chronic kidney disease (CKD) progression. Although longitudinal monitoring of B-type natriuretic peptide (BNP) may aid physicians' decision making about the optimization of volume status, its clinical benefit remains uncertain in CKD. This study assessed the association between BNP monitoring and the risk of incident kidney replacement therapy (KRT).

Community-engaged training in informed consent.

Inadequate training in the interpersonal skills of conducting informed consent conversations has long been noted as a challenge for clinical research recruitment and retention. To address this critical gap, Tufts Clinical and Translational Science Institute developed regular trainings for clinical research coordinators and other research staff on the practical skills of communicating informed consent using community members as simulated patients for role-playing exercises. In this paper, we assess the reach and effectiveness of these trainings and describe the impact of employing community stakeholders as simulated patients.

The Natural History of Bicuspid Aortic Valve Disease.

The bicuspid aortic valve (BAV) is the most common congenital heart defect with an estimated prevalence of between 0.5% and 2% in the United States, representing up to 6.5 million individuals.

Acute Declines in Estimated GFR in Blood Pressure Target Trials and Risk of Adverse Outcomes.

Rationale & Objective: Acute decreases in glomerular filtration rate (GFR) occur commonly during intensive blood pressure (BP) lowering. Our objective was to determine the relationship between acute decreases in estimated GFR and patient outcomes.

Study Design: Retrospective observational study.

Pulmonary Artery Catheter Use and Risk of In-hospital Death in Heart Failure Cardiogenic Shock.

Background: Pulmonary artery catheters (PACs) are increasingly used to guide management decisions in cardiogenic shock (CS). The goal of this study was to determine if PAC use was associated with a lower risk of in-hospital mortality in CS owing to acute heart failure (HF-CS).

Methods And Results: This multicenter, retrospective, observational study included patients with CS hospitalized between 2019 and 2021 at 15 US hospitals participating in the Cardiogenic Shock Working Group registry.

Key issues for stakeholder engagement in the development of health and healthcare guidelines.

Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues.

Rapid resolution of hyperfibrinolysis in dogs with spontaneous hemoperitoneum following surgical control of hemorrhage.

Objective: To estimate the point prevalence and duration of hyperfibrinolysis (HF) in dogs undergoing surgical control of spontaneous hemoperitoneum (SHP).

Design: Prospective observational study.

Setting: Single veterinary teaching hospital.

Compared with conventional insemination, intracytoplasmic sperm injection provides no benefit in cases of nonmale factor infertility as evidenced by comparable euploidy rate.

Objective: To evaluate whether differences in euploidy rates exist between intracytoplasmic sperm injection (ICSI) and conventional insemination (CI) in nonmale factor infertility cases.

Design: Retrospective cohort study.

Setting: A single, academically affiliated infertility center in the United States.

The bidirectional association between atrial fibrillation and myocardial infarction.

Atrial fibrillation (AF) is associated with an increased risk of myocardial infarction (MI) and vice versa. This bidirectional association relies on shared risk factors as well as on several direct and indirect mechanisms, including inflammation, atrial ischaemia, left ventricular remodelling, myocardial oxygen supply-demand mismatch and coronary artery embolism, through which one condition can predispose to the other. Patients with both AF and MI are at greater risk of stroke, heart failure and death than patients with only one of the conditions.

Effects of municipal smoke-free ordinances on secondhand smoke exposure in the Republic of Korea.

Objective: To reduce premature deaths due to secondhand smoke (SHS) exposure among non-smokers, the Republic of Korea (ROK) adopted changes to the National Health Promotion Act, which allowed local governments to enact municipal ordinances to strengthen their authority to designate smoke-free areas and levy penalty fines. In this study, we examined national trends in SHS exposure after the introduction of these municipal ordinances at the city level in 2010.

Methods: We used interrupted time series analysis to assess whether the trends of SHS exposure in the workplace and at home, and the primary cigarette smoking rate changed following the policy adjustment in the national legislation in ROK.

Developing an engaging and accessible clinical research training program for new investigators.

Clinicians who are interested in becoming principal investigators struggle to find and complete training that adequately prepares them to conduct safe, well-designed clinical and translational research. Degree programs covering these skills require a significant time investment, while online trainings lack engagement and may not be specific to local research contexts. Staff at Tufts Clinical and Translational Science Institute sought to fill the gap in junior investigator training by designing an eight-module, noncredit certificate program to teach aspiring clinician-investigators about good clinical practice, clinical research processes, and federal and local regulatory requirements.