Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial

In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment.
The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies.
The two specific aims for this research are:
* Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups
* Aim 2: To compare two safety event detection methods, medical record review, and video review

开始日期2025-07-01

申办/合作机构

Boston Medical Center

[+1]

NCT06481670 / Not yet recruitingN/AIIT

The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients

This study is a prospective randomized clinical controlled trial testing the effects of pre-operative >50 g pre-operative carbohydrate fluids (apple juice) on a patient's post-operative nausea and vomiting (PONV) incidence and intensity. Optimizing fluid therapy in the peri-operative setting has been proven to improve patient outcomes and reduce complications and length of hospital stay. Based on practice guidelines under the American Society of Anesthesiologists, pre-operative hydration with complex carbohydrate drinks is safe and should be encouraged as it helps with improving metabolism to an anabolic state, decreases insulin resistance, reduces anxiety, and reduces PONV. While pre-operative carbohydrate (CHO) fluids have already been studied and adopted by other surgical specialities (Vascular, General Surgery, Orthopaedics, etc.), this has not yet been studied in oral and maxillofacial surgery, especially at Boston Medical Center (BMC).
During surgery, each participant will undergo our current Enhanced Recovery After Surgery "ERAS" protocol, which includes general anesthesia using inhalational gas, judicious IV fluids, intra-operative steroid and ondansetron (anti-emetic), use of 0.5% bupivacaine local anesthesia per quadrant at surgery end time, use of a throat pack, and orogastric/nasogastric (OG/NG) tube suctioning prior to extubation to minimize ingestion of blood. Pain and anxiety medications prior to and during surgery include 2 mg midazolam, fentanyl per anesthesia, toradol, and dexmedetomidine. Having this protocol will help minimize confounding variables that could affect the primary outcome-- incidence and severity of PONV.
The objectives for this research are:
* To evaluate if pre-operative clear CHO help reduce incidence and intensity of PONV.
* To assess if pre-operative clear carbohydrate fluids affect length of hospital stay
* To determine if pre-operative CHO reduce patient's pre-/post-operative anxiety
* To compare the amount/number of opioids and anti-emetics needed post-operatively between the two groups
* To compare ability for patients to return to PO hydration via the amount of fluid ingestion (mL) vs. if they need IV fluids due to decreased PO intake/inability to tolerate PO fluids
* To evaluate if patient Apfel score is also a strong indicator for incidence/severity of PONV

开始日期2025-06-01

申办/合作机构

Boston Medical Center

NCT06187701 / Not yet recruitingN/AIIT

Pilot Study on the Use of the Co-Active Therapeutic Theatre (Co-ATT) Manualised Model of Drama Therapy for the Treatment of Patients With Co-occurring Primary Psychiatric and Substance Use Disorders

Drama Therapy involves of the use of theatrical techniques (such as script development, acting exercises, improvisation, etc.) to help treat patients' mental illness and improve their functioning and overall sense of wellbeing.
This study will evaluate the effectiveness of a specific version of drama therapy for the treatment of patients suffering from both mental illness (such as depression, bipolar disorder, schizophrenia, etc.) and one or more substance use disorders. The study will also assess participants feelings and thoughts about the drama therapy intervention (such as whether or not they enjoyed it and if/how they found it helpful).
The drama therapy intervention will consist of one group drama therapy session per week, for a total of twelve weeks (i.e., total twelve sessions) followed by a single performance (with composition of the audience determined by unanimous agreement of the participants) of the dramatic work (script) produced by the participants during the course of the drama therapy intervention.

开始日期2025-03-01

申办/合作机构

Boston Medical Center

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项与 Boston Medical Center 相关的文献（医药）

2025-02-01·EPILEPSY & BEHAVIOR

Role for a video tool in educating youth with epilepsy about anticonvulsant and contraceptive drug interactions

Article

作者: Kriska M Ponce, Rovingaile ; Lopez, Natalia I ; Dang, Camille A ; Douglass, Laurie M ; Niemann, Madeline ; Jonas, Rinat ; Jacobellis, Sara

PURPOSE:

Anti-seizure medications (ASM) can lower the efficacy of hormonal birth control (BC), while estrogen-containing BC can increase ASM metabolism, altering seizure frequency. Despite these adverse interactions, many youth with epilepsy demonstrate inadequate knowledge about this topic. Thus, there is a need to develop tools that empower youth with epilepsy to make more informed contraceptive decisions. This study assesses the use of a video-based educational tool to raise awareness of BC and ASM interactions in this population.

METHODS:

We created a video that gives an overview of possible interactions between certain BC methods and ASMs, mainly increased risk of pregnancy and change in seizure frequency. The video was shown to female patients aged 12 and older with epilepsy in a child neurology clinic and followed by a discussion with their treating neurologist. Fifteen patients completed two surveys that collected demographics, ASM regimen, BC history, and assessed exposure to and understanding of the subject matter before and after viewing the educational tool using 11-point Likert scales. We received seven responses from provider opinion surveys that were administered after the visit to assess the practicality of the video tool in teaching patients about their medication interactions. Data was analyzed with descriptive statistics and one-tailed paired t-tests (α = 0.05).

RESULTS:

Patients ranged from ages 16 to 24, with 46.7 % being in the 16 to 18 year-old range, 26.7 % in the 19 to 21 year-old range, and 26.7 % in the 22 to 24 year-old range. The median age was 19. 33 % of the patients reported having used BC, with 27 % reporting current interest in using BC. 33 % of patients were taking ASM that could reduce BC efficacy, and 27 % were on ASM with efficacy that can be reduced by BC. While 80 % of patients endorsed having previously discussed BC and ASM interactions with a doctor, patients rated their knowledge of the subject pre-video as moderately low with high interest in learning more about the topic. Patients' understanding of how BC and ASM interactions can increase risk of pregnancy showed a significant increase post-video. Patients also indicated a high likelihood that they would think of the video when choosing a BC method and that they are more likely to start a discussion with their doctor about BC and ASM interactions because of the video. Treating neurologists showed high agreement that the video is useful in teaching their patients about BC and ASM interactions.

CONCLUSION:

Youth with epilepsy deserve engaging resources that empower them to make informed decisions about BC. Despite most of our patients having had prior education about BC and ASM interactions, our results support the need for educational tools beyond patient-provider discussion and the efficacy of video as a tool to enhance understanding of this topic. The tool also showed potential to influence future patient decision making regarding BC and to empower patients to take an active role in discussing BC with their doctor. Our findings support a role for educational videos as an effective way to teach youth with epilepsy about reproductive health concerns and to promote active participation in decision making.

2025-02-01·ENVIRONMENTAL RESEARCH

Associations between per- and polyfluoroalkyl substances (PFAS) and female sexual function in a preconception cohort

Article

作者: Wise, Lauren A ; Calafat, Antonia M ; Hatch, Elizabeth E ; Wegienka, Ganesa ; Bond, Julia C ; White, Katharine O ; Cook Botelho, Julianne ; Schildroth, Samantha ; Wesselink, Amelia K ; Abrams, Jasmine

BACKGROUND:

Female sexual function is important for sexual well-being, general health, fertility, and relationship satisfaction. Distressing impairments in sexual function, clinically recognized as female sexual dysfunction (FSD), can manifest as issues with interest/desire, arousal, orgasm, and pain during vaginal penetration. Some evidence suggests that exposure to endocrine-disrupting chemicals may adversely affect female sexual function, but associations for per- and polyfluoroalkyl substances (PFAS) have not been previously evaluated.

OBJECTIVE:

We investigated associations between serum PFAS concentrations and female sexual function among U.S. pregnancy planners.

METHODS:

We used cross-sectional data from participants from Pregnancy Study Online (PRESTO), a prospective preconception cohort study. Participants reported sexual function and distress at baseline on two validated measures: a modified version of the Female Sexual Function Index-6 (FSFI-6) and the Female Sexual Distress Scale (FSDS). We quantified PFAS serum concentrations in samples collected in the preconception period (i.e., at baseline) using solid phase extraction-high performance liquid chromatography-isotope-dilution-mass spectrometry. Participants reported sociodemographic information on structured baseline questionnaires. We included 78 participants with complete PFAS and sexual function data and fit multivariable linear regression models to estimate mean differences in FSFI-6 scores (β) or percent differences (%) in FSDS scores per interquartile range (IQR) increase in PFAS concentrations, adjusting for age, annual household income, years of education, parity, and body mass index. We further investigated effect measure modification by parity (parous vs. nulliparous) in stratified models.

RESULTS:

An IQR increase in perfluorohexanesulfonic acid was associated with a 1.0-point decrease (95% CI = -1.8, -0.1) in reported FSFI-6 scores, reflecting poorer sexual function. PFAS were consistently associated with lower FSFI-6 scores among parous participants. PFAS were also associated, though imprecisely, with greater sexual distress.

CONCLUSION:

Some PFAS were associated with poorer sexual function among U.S. pregnancy planners, but future studies are needed to clarify the extent to which PFAS influences female sexual health.

2025-01-14·NEUROLOGY

Association Between Time to Treatment and Outcomes of Endovascular Therapy vs Medical Management in Patients With Large Ischemic Stroke

Article

作者: He, Bo ; Huang, Feng ; Wang, Mengxing ; Feng, Can ; Saver, Jeffrey L. ; Liang, Yong ; Xia, Hong ; Qiu, Zhongming ; Xiang, Youxi ; Cai, Xueli ; Liu, Lei ; Nguyen, Thanh N. ; Huo, Xiaochuan ; Lei, Libo ; Zhou, Xianghong ; Wu, Derong ; Miao, Zhongrong ; Huang, Zhu ; Long, Chen ; Wu, Junxiong ; Sang, Hongfei ; Xu, Jun ; Wang, Hailing ; Yang, Wenbin ; Yuan, Guangxiong ; Pan, Yuesong

BACKGROUND AND OBJECTIVES:

Randomized trials have proven the benefit of endovascular therapy (EVT) for acute large ischemic stroke. This study was to characterize the effect of time to treatment on benefit of EVT vs medical management (MM) among patients with large ischemic stroke.

METHODS:

This was a post hoc analysis of the Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core randomized trial. Patients who had an Alberta Stroke Program Early Computed Tomography Score of 3-5 or an ischemic core volume of 70-100 mL within 24 hours of symptom onset were treated with EVT plus MM or MM. Onset-to-expected arterial puncture time (OPT) was analyzed as a categorical variable (<6, 6-<12, and 12-24 hours) using binary logistic regression and as a continuous variable using a multivariable fractional polynomial interaction. The primary efficacy outcome was favorable outcomes (modified Rankin Scale scores 0-3) at 90 days. Safety outcomes included any intracranial hemorrhage (ICH), symptomatic ICH, and mortality.

RESULTS:

Among 451 patients (median age 68 years; 61.4% were men; median OPT 487 minutes [interquartile range 328-802]), 226 patients received EVT and 225 patients received MM. The EVT group showed higher rates of favorable outcomes than the MM group within OPT of 6 hours (44.4% vs 29.9%, adjusted odds ratio [aOR] 2.78, 95% CI 1.22-6.32) and 6-12 hours (45.7% vs 29.6%, aOR 2.39 [95% CI 1.21-4.71]), but not in OPT beyond 12 hours (51.6% vs 41.4%, aOR 2.05 [95% CI 0.88-4.77]). The benefit became nonsignificant after OPT of 13 hours and 22 minutes. In 3 OPT intervals, the rates of symptomatic ICH and mortality were similar between EVT and MM although the rate of any ICH increased. However, no interaction effect was found (all p interactions >0.10).

DISCUSSION:

These findings strengthen the benefit of EVT initiated within 13 hours and 22 minutes after symptom onset compared with MM alone in patients with large ischemic stroke, but EVT should not be withheld for patients presenting beyond 13 hours and 22 minutes. Pooled analysis of larger sample sizes is needed.

TRIAL REGISTRATION INFORMATION:

ClinicalTrials.gov; NCT04551664.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that EVT is associated with improved functional outcomes for acute large ischemic stroke within 24 hours after last known well, with no interaction by time.

123

项与 Boston Medical Center 相关的新闻（医药）

2024-11-20

·GlobeNewswire-Health Care

Route 92 Medical Gains EU and MDSAP Certification for its Neurovascular Stroke-Intervention-Focused Product Portfolio

SAN MATEO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the achievement of European Union approval (CE mark) under the EU Medical Device Regulation (MDR) 2017/745 for its innovative line of neurovascular intervention products. The company also announced clearance under the MDSAP program which gives broad access to international markets. “Securing EU MDR certification for our portfolio of reperfusion systems opens the door to entering the European market, and can lower the regulatory barriers to enter other new markets,” said Tony Chou, M.D., Route 92 Medical’s founder and Chief Executive Officer. “Navigating the EU MDR certification process was a significant challenge, requiring compliance with an extensive framework of regulations and guidance documents, as well as extensive communications with our notified body. This approval represents a critical milestone in our progress towards becoming a global player in the neurovascular intervention market. While our focus today is the U.S., we can now work toward commercializing our products in Europe.” Route 92 Medical’s products are covered by a global portfolio of more than 100 patents. The regulatory authorization covers the majority of the company’s products including: HiPoint 70/Tenzing 7 Reperfusion SystemHiPoint 88/Tenzing 8 Reperfusion SystemFreeClimb 70/Tenzing 7 Reperfusion SystemFreeClimb 88/Tenzing 8 Reperfusion SystemBase Camp Sheath System “European clinicians welcome the availability of additional, high-quality tools to support neurovascular procedures and treat acute ischemic stroke," said Francesco Massari, M.D., MSc, Ph.D., Associate Professor of Radiology at Boston University Medical School and NeuroInterventionalist at Boston Medical Center, who trained at the University of Rome Tor Vergata. "Leveraging the power of its Tenzing catheters, Route 92 Medical's products offer clinicians new and improved ways to atraumatically advance through the challenging-to-navigate neurovasculature to reach and remove clots, without the need for guidewires and crossing the clot, thus facilitating efficient procedures and robust first-pass effect." For more information about Route 92 Medical, visit www.r92m.com. About Route 92 Medical, Inc. Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn.

2024-11-19

·Business Wire

VSee Health, Health Tech Without Borders, and iDocta Expand Clinton Global Initiative Telehealth Pilots in Conflict-affected Regions of Africa

SAN JOSE, Calif.--( BUSINESS WIRE )-- VSee Health, Inc . (Nasdaq: VSEE), a provider of comprehensive digital health services for the rapid and scalable development of secure, customized telehealth workflow streams; Health Tech Without Borders (HTWB) a global non-profit providing digital health interventions in humanitarian crises; and iDocta, a medical digitization company, are expanding the Project VITAL Africa telehealth pilots – a commitment made at the Clinton Global Initiative 2023 Annual Meeting in September 2023 – to strengthen health systems and promote equitable health in Cameroon through sustainable training, telehealth, and innovative technology. Dr. Milton Chen, Co-CEO of VSee Health said, “VSee Health from its beginning has been focused on designing secure, robust, and scalable technology that impacts our society. The successful use of our customizable platform to provide healthcare access in war-torn and remote parts of Africa demonstrates exactly what our technology was built to do. We’re proud to take part in this Clinton Global Initiative commitment and to support HTWB and iDocta in a meaningful way.” Mary Showstark, HTWB Chief Liaison Officer stated, “We feel fortunate to have partnered with VSee Health on multiple humanitarian projects. Its telehealth platform has proven to be reliable, adaptable, and quick to set up, especially for life and death situations. It makes it possible for us to do what we do: provide immediate access to care in disasters and emergencies.” “We are excited with the progress we have made with Project VITAL,” said Yap Boum, iDocta founder. “We look forward to this next phase of our work in Cameroon, building sustainability with local expertise and expanding telemedicine services to more locations that are in desperate need of healthcare access.” Conflict-affected regions like Cameroon and the Sahel region bordering the Sahara Desert are home to over 30 million people needing humanitarian and mental health support, and who face the world’s highest maternal mortality rates. These challenges are compounded by climate change, leading to extreme heat, droughts, and agricultural degradation, alongside ongoing security concerns. As a result, displaced populations suffer from increasingly inadequate access to healthcare. In response, Project VITAL ( Virtual International Telehealth and Leadership) in Africa seeks to establish a sustainable, culturally sensitive telehealth program in these areas, built on the pillars of sustainability, safety, and security. In a closely coordinated effort, Health Tech Without Borders, iDocta, and VSee Health, in early 2024, launched two telehealth pilot programs utilizing the VSee Health telehealth platform in Cameroon’s capital city of Yaoundé, yielding valuable insights for further development. The team is now expanding to include additional clinicians and technical experts, enhancing services such as telehealth, home visits, and pharmacy requests. Following Project VITAL’s sustainability commitment, it is partnering with Sand Technologies, ALX Africa, and African Leadership University (ALU) to bring in local programmers and coders to manage and maintain the platform. Following the pilot, efforts will focus on overcoming barriers in remote areas by expanding to remote North/Northwest regions, addressing legal, financial, technological, and cultural barriers. Project VITAL emphasizes sustainable partnerships and equity principles to improve healthcare access and empower communities in these vulnerable regions. Its other commitment partners include Boston Medical Center, Central Africa Republic, Institut Pasteur de Bangui, Massachusetts General Hospital Center for Global Health, Medical Device "Plug-and-Play" (MD PnP), Reach Out NGO, The FutureList global innovation scouts, Stanford University - Stanford Medicine, and Yale Institute for Global Health (YIGH). About VSee Health VSee Health’s AI telehealth platform is the fastest way for enterprises to go from ideation to market go-live. Field-hardened on over 1.5M HIPAA-compliant video encounters every month, its customizable telehealth building blocks each meet stringent government security standards, and are ready to scale. VSee Health has traveled for field deployments to over 50 countries such as Iraq, Syria, Marshall Islands and El Salvador. Its clients include NASA Space Station, US Department of Health and Human Services, McKesson, Magellan, DaVita, GE, countless startups, and the entire country of Qatar. VSee Health also provides tailored solutions for critical shortage areas such as critical care and teleradiology. It is committed to empowering high quality healthcare access and reducing physician burnout and workforce shortages through its telehealth technology. Visit vseehealth.com . About Health Tech Without Borders Health Tech Without Borders (HTWB) is a global non-profit organization that supports local communities affected by sudden humanitarian emergencies via digital tools. As an innovation hub, HTWB collaborates with international public and private partners to provide access to care and health education to those afflicted by conflict and climate change. HTWB focuses on supporting any person affected by humanitarian disasters while remaining non-sectarian and apolitical. Learn more at htwb.org About iDocta iDocta is a social innovation company specializing in the digitalization of medical services and the digital transformation of the health system in Cameroon and Africa. The goal of iDocta is to create a digital platform that will first bring together all the expertise in the field of medicine in Africa and its diaspora and serve as a bridge to traditional medicine. Our goal is to create the most prominent virtual clinic in Africa to ensure no one is left behind. Follow facebook.com/IDocta/ About the Clinton Global Initiative (CGI) Founded by President Bill Clinton in 2005, the Clinton Global Initiative is a community of doers representing a broad cross section of society and dedicated to the idea that we can accomplish more together than we can apart. Through CGI’s unique model, more than 10,000 organizations have launched more than 4,000 Commitments to Action — new, specific, and measurable projects and programs – that are making a difference in the lives of more than 500 million people in 180 countries. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Certain of these forward-looking statements can be identified by the use of words such as “believes,” “expects,” “intends,” “plans,” “estimates,” “assumes,” “may,” “should,” “will,” “seeks,” or other similar expressions. Such statements may include, but are not limited to, statements regarding the Company’s ability to regain compliance with Nasdaq’s listing rules within the required timeframe. These statements are based on current expectations on the date of this press release and involve a number of risks and uncertainties that may cause actual results to differ significantly, including those risks set forth in the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q and other documents filed with the SEC. Copies of such filings are available on the SEC’s website at www.sec.gov . The Company does not assume any obligation to update or revise any such forward-looking statements, whether as the result of new developments or otherwise. Readers are cautioned not to put undue reliance on forward-looking statements.

2024-10-25

·Pharmaceutical Technology

Takeda and BMC partner to decarbonise US healthcare sector

The collaboration specifically targets GHGs from pharmaceutical packaging and single-use plastics. Credit: Mumemories/Shutterstock. Takeda and the Boston Medical Center (BMC) have announced a partnership aimed at tackling decarbonisation across the US healthcare ecosystem. Their collaboration specifically targets the reduction of greenhouse gas emissions (GHGs) due to regulated medical waste disposal, such as single-use plastics and pharmaceutical packaging. It is poised to identify and pilot solutions to reduce hard-to-abate emissions, and to share findings to facilitate adoption across the healthcare industry. By implementing waste audits and testing new technologies, BMC aims to pinpoint emission hotspots and address them effectively. BMC health system senior vice-president and chief sustainability and real estate officer Robert Biggio stated: “Increasing health risks exacerbated by climate change, such as extreme heat, pollution, biodiversity loss and other environmental impacts, are a real and direct threat to patient and community wellbeing. “Our collaboration with Takeda aims to drive meaningful change by tackling environmental challenges that contribute to health disparities in many communities. “This collaboration is a critical step in driving innovation in the medical supply chain that can be shared with other health care organisations for a healthier environment for all communities.” For Takeda, the initiative aligns with its commitment to achieving net zero GHG emissions by 2035 in its operations and by 2040 across its value chain. The Science Based Targets initiative (SBTi) validated Takeda’s GHG emission goals in 2024, confirming their alignment with the global effort to limit temperature rise to 1.5°C above pre-industrial levels. BMC is the first hospital in the US to utilise a rooftop solar array to aid patients with energy insecurity, and has established rooftop farms to supply fresh produce for its needs. It opened the first net-zero-ready behavioural health facility and issued sustainability bonds, raising $232m for campus renovations to enhance patient care. The collaboration between Takeda and BMC will involve engaging with industry stakeholders, including waste vendors and suppliers, to establish and disseminate new best practices.