Vaso occlusive crisis is the most common clinical manifestation of sickle cell disease. It is responsible for a significant volume of hospitalizations and emergency department visits by the affected patients. Recent studies suggest that nearly half of the people suffering from sickle cell disease experience vaso occlusive crisis, with some patients having 6 or more such episodes every year. Repeated episodes can lead to severe health complications and thus, there is a heightened impetus to develop effective drugs to alleviate the condition.

The global medical monitoring services market is experiencing robust growth, driven by the increasing prevalence of chronic diseases, the rising complexity of clinical trials, and the growing demand for efficient and reliable data management in healthcare. The market's expansion is further fueled by technological advancements, particularly in electronic data capture (EDC) and remote patient monitoring, which enhance data quality and accessibility. Key application segments include biotechnology and pharmaceuticals, contract research organizations (CROs), and hospitals, all benefiting from streamlined processes and improved patient safety afforded by comprehensive medical monitoring. The market is segmented by service type, encompassing critical areas such as inclusion/exclusion criteria management, protocol deviations tracking, safety reporting (SAE), and medical crisis monitoring. The increasing adoption of sophisticated medical monitoring services is leading to better clinical trial outcomes, reduced operational costs, and ultimately, improved patient care. We project significant market expansion over the coming years, driven by consistent innovation and a growing emphasis on data-driven decision-making across the healthcare sector. Geographical expansion presents another significant growth avenue. North America currently dominates the market, owing to robust regulatory frameworks, high healthcare spending, and a large pharmaceutical industry. However, regions like Asia Pacific are witnessing rapid growth, fueled by rising healthcare infrastructure investment and an expanding pharmaceutical and biotechnology sector. This geographical shift reflects evolving global healthcare priorities and the increasing adoption of advanced medical monitoring solutions in emerging economies. While challenges such as regulatory hurdles and data privacy concerns exist, the overall market outlook remains positive, with consistent growth projected throughout the forecast period. The growing need for effective risk management, coupled with the rise of telehealth and remote monitoring capabilities, will continue to drive innovation and expansion within the medical monitoring services sector.

COVID-19 impact on patients participating in an ongoing clinical trial.

Sickle cell disease, a genetic disorder of hemoglobin, affects around 1 in 500 African American children and about 1 in 36,000 Hispanic-American children. A painful vaso-occlusive crisis is reported as the most common reason for emergency department visits and hospitalization among sickle cell disease patients. To combat the disease and improve the quality of life of the affected individuals, there is increased focus on the development of investigational drugs that can reduce the frequency and severity of vaso occlusive crisis.

BackgroundCompulsory admission to psychiatric hospitals may be distressing, disruptive to patients and families, and associated with considerable cost to the health service. Improved patient experience and cost reductions could be realised by providing cost-effective crisis planning services.MethodsEconomic evaluation within a multi-centre randomised controlled trial comparing Joint Crisis Plans (JCP) plus treatment as usual (TAU) to TAU alone for patients aged over 16, with at least one psychiatric hospital admission in the previous two years and on the Enhanced Care Programme Approach register. JCPs, containing the patient's treatment preferences for any future psychiatric emergency, are a form of crisis intervention that aim to mitigate the negative consequences of relapse, including hospital admission and use of coercion. Data were collected at baseline and 18-months after randomisation. The primary outcome was admission to hospital under the Mental Health Act. The economic evaluation took a service perspective (health, social care and criminal justice services) and a societal perspective (additionally including criminal activity and productivity losses).FindingsThe addition of JCPs to TAU had no significant effect on compulsory admissions or total societal cost per participant over 18-months follow-up. From the service cost perspective, however, evidence suggests a higher probability (80%) of JCPs being the more cost-effective option. Exploration by ethnic group highlights distinct patterns of costs and effects. Whilst the evidence does not support the cost-effectiveness of JCPs for White or Asian ethnic groups, there is at least a 90% probability of the JCP intervention being the more cost-effective option in the Black ethnic group.InterpretationThe results by ethnic group are sufficiently striking to warrant further investigation into the potential for patient gain from JCPs among black patient groups.Trial RegistrationCurrent Controlled Trials ISRCTN11501328

The global medical monitoring services market is experiencing robust growth, driven by the increasing prevalence of chronic diseases, rising clinical trial activities, and stringent regulatory requirements for patient safety. The market is segmented by application (Biotechnology and Pharmaceuticals, Contract Research Organizations (CROs), Hospitals, KPO/BPO, Healthcare Institutions, Others) and type of service (Inclusion/exclusion criteria issues, protocol exemptions and deviations, medical crisis monitoring, medication issues, laboratory findings, SAE reporting, others). The large pharmaceutical and biotechnology sectors, coupled with the expanding CRO industry, are significant contributors to market expansion. Technological advancements in data analytics and remote monitoring capabilities are further fueling market growth, enabling more efficient and comprehensive patient surveillance. North America currently holds a dominant market share due to the high concentration of pharmaceutical companies, advanced healthcare infrastructure, and robust regulatory frameworks. However, Asia Pacific is projected to witness significant growth during the forecast period (2025-2033), driven by increasing healthcare expenditure and growing adoption of advanced medical technologies in developing economies like India and China. The market faces challenges including high costs associated with medical monitoring and the need for skilled professionals, which may slightly restrain growth. The projected Compound Annual Growth Rate (CAGR) for the medical monitoring services market, while not explicitly stated, can be reasonably estimated, considering the factors outlined above, to be in the range of 7-9% from 2025 to 2033. This growth reflects the continuous demand for improved patient safety and regulatory compliance. Market size in 2025 can be estimated at around $15 billion, based on general industry knowledge and the size of related markets. This figure will likely increase significantly by 2033, driven by the aforementioned growth drivers. The key players mentioned (Pharm-Olam, Veristat, ProPharma Group, etc.) are actively contributing to this growth through continuous innovation and expansion of their services and geographic reach. Strategic partnerships and acquisitions within the industry are also expected to consolidate market share and stimulate further expansion.

Update — December 7, 2014. – Evidence-based medicine (EBM) is not working for many reasons, for example: 1. Incorrect in their foundations (paradox): hierarchical levels of evidence are supported by opinions (i.e., lowest strength of evidence according to EBM) instead of real data collected from different types of study designs (i.e., evidence). http://dx.doi.org/10.6084/m9.figshare.1122534 2. The effect of criminal practices by pharmaceutical companies is only possible because of the complicity of others: healthcare systems, professional associations, governmental and academic institutions. Pharmaceutical companies also corrupt at the personal level, politicians and political parties are on their payroll, medical professionals seduced by different types of gifts in exchange of prescriptions (i.e., bribery) which very likely results in patients not receiving the proper treatment for their disease, many times there is no such thing: healthy persons not needing pharmacological treatments of any kind are constantly misdiagnosed and treated with unnecessary drugs. Some medical professionals are converted in K.O.L. which is only a puppet appearing on stage to spread lies to their peers, a person supposedly trained to improve the well-being of others, now deceits on behalf of pharmaceutical companies. Probably the saddest thing is that many honest doctors are being misled by these lies created by the rules of pharmaceutical marketing instead of scientific, medical, and ethical principles. Interpretation of EBM in this context was not anticipated by their creators. “The main reason we take so many drugs is that drug companies don’t sell drugs, they sell lies about drugs.” ―Peter C. Gøtzsche “doctors and their organisations should recognise that it is unethical to receive money that has been earned in part through crimes that have harmed those people whose interests doctors are expected to take care of. Many crimes would be impossible to carry out if doctors weren’t willing to participate in them.” —Peter C Gøtzsche, The BMJ, 2012, Big pharma often commits corporate crime, and this must be stopped. Pending (Colombia): Health Promoter Entities (In Spanish: EPS ―Empresas Promotoras de Salud).

1. Misinterpretations New technologies or concepts are difficult to understand in the beginning, it doesn’t matter their simplicity, we need to get used to new tools aimed to improve our professional practice. Probably the best explanation is here in these videos (credits to Antonio Villafaina for sharing these videos with me). English https://www.youtube.com/watch?v=pQHX-SjgQvQ&w=420&h=315 Spanish https://www.youtube.com/watch?v=DApozQBrlhU&w=420&h=315 ----------------------- Hypothesis: hierarchical levels of evidence based medicine are wrong Dear Editor, I have data to support the hypothesis described in the title of this letter. Before rejecting the null hypothesis I would like to ask the following open question:Could you support with data that hierarchical levels of evidence based medicine are correct? (1,2) Additional explanation to this question: – Only respond to this question attaching publicly available raw data.– Be aware that more than a question this is a challenge: I have data (i.e., evidence) which is contrary to classic (i.e., McMaster) or current (i.e., Oxford) hierarchical levels of evidence based medicine. An important part of this data (but not all) is publicly available. References
2. Ramirez, Jorge H (2014): The EBM challenge. figshare. http://dx.doi.org/10.6084/m9.figshare.1135873
3. The EBM Challenge Day 1: No Answers. Competing interests: I endorse the principles of open data in human biomedical research Read this letter on The BMJ – August 13, 2014.http://www.bmj.com/content/348/bmj.g3725/rr/762595Re: Greenhalgh T, et al. Evidence based medicine: a movement in crisis? BMJ 2014; 348: g3725. _ Fileset contents Raw data: Excel archive: Raw data, interactive figures, and PubMed search terms. Google Spreadsheet is also available (URL below the article description). Figure 1. Unadjusted (Fig 1A) and adjusted (Fig 1B) PubMed publication trends (01/01/1992 to 30/06/2014). Figure 2. Adjusted PubMed publication trends (07/01/2008 to 29/06/2014) Figure 3. Google search trends: Jan 2004 to Jun 2014 / 1-week periods. Figure 4. PubMed publication trends (1962-2013) systematic reviews and meta-analysis, clinical trials, and observational studies.
   Figure 5. Ramirez, Jorge H (2014): Infographics: Unpublished US phase 3 clinical trials (2002-2014) completed before Jan 2011 = 50.8%. figshare.http://dx.doi.org/10.6084/m9.figshare.1121675 Raw data: "13377 studies found for: Completed | Interventional Studies | Phase 3 | received from 01/01/2002 to 01/01/2014 | Worldwide". This database complies with the terms and conditions of ClinicalTrials.gov: http://clinicaltrials.gov/ct2/about-site/terms-conditions Supplementary Figures (S1-S6). PubMed publication delay in the indexation processes does not explain the descending trends in the scientific output of evidence-based medicine. Acknowledgments I would like to acknowledge the following persons for providing valuable concepts in data visualization and infographics:
4. Maria Fernanda Ramírez. Professor of graphic design. Universidad del Valle. Cali, Colombia.
5. Lorena Franco. Graphic design student. Universidad del Valle. Cali, Colombia. Related articles by this author (Jorge H. Ramírez)
6. Ramirez JH. Lack of transparency in clinical trials: a call for action. Colomb Med (Cali) 2013;44(4):243-6. URL: http://www.ncbi.nlm.nih.gov/pubmed/24892242
7. Ramirez JH. Re: Evidence based medicine is broken (17 June 2014). http://www.bmj.com/node/759181
8. Ramirez JH. Re: Global rules for global health: why we need an independent, impartial WHO (19 June 2014). http://www.bmj.com/node/759151
9. Ramirez JH. PubMed publication trends (1992 to 2014): evidence based medicine and clinical practice guidelines (04 July 2014). http://www.bmj.com/content/348/bmj.g3725/rr/759895 Recommended articles
10. Greenhalgh Trisha, Howick Jeremy,Maskrey Neal. Evidence based medicine: a movement in crisis? BMJ 2014;348:g3725
11. Spence Des. Evidence based medicine is broken BMJ 2014; 348:g22
12. Schünemann Holger J, Oxman Andrew D,Brozek Jan, Glasziou Paul, JaeschkeRoman, Vist Gunn E et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies BMJ 2008; 336:1106
13. Lau Joseph, Ioannidis John P A, TerrinNorma, Schmid Christopher H, OlkinIngram. The case of the misleading funnel plot BMJ 2006; 333:597
14. Moynihan R, Henry D, Moons KGM (2014) Using Evidence to Combat Overdiagnosis and Overtreatment: Evaluating Treatments, Tests, and Disease Definitions in the Time of Too Much. PLoS Med 11(7): e1001655. doi:10.1371/journal.pmed.1001655
15. Katz D. A-holistic view of evidence based medicinehttp://thehealthcareblog.com/blog/2014/05/02/a-holistic-view-of-evidence-based-medicine/ ---

Clinical Trial Equipment & Ancillary Solutions Market Outlook

The global Clinical Trial Equipment & Ancillary Solutions market is projected to reach USD 12.5 billion by 2032, growing at a CAGR of 6.8% from 2024 to 2032. The market growth is primarily driven by the increasing prevalence of chronic diseases and the rising number of clinical trials globally.

One of the primary growth factors for the Clinical Trial Equipment & Ancillary Solutions market is the surge in clinical trials due to the rising prevalence of chronic diseases such as cancer, diabetes, and cardiovascular ailments. As healthcare sectors worldwide are investing heavily in research and development to discover new treatment methodologies and drugs, the demand for clinical trial equipment and ancillary solutions has seen a significant uptick. Furthermore, the COVID-19 pandemic has underscored the importance of rapid development and deployment of clinical trials to combat global health crises, further propelling market growth.

Technological advancements in clinical trial equipment and ancillary solutions are another critical driver of market growth. The integration of cutting-edge technologies such as artificial intelligence (AI), machine learning (ML), and the Internet of Things (IoT) into clinical trial processes has revolutionized the way trials are conducted. These technologies enhance the efficiency, accuracy, and speed of trials, reducing costs and improving outcomes. For instance, AI-powered imaging equipment can provide real-time, high-resolution images that facilitate better diagnostics and monitoring. Similarly, IoT-enabled monitoring devices can track patient health metrics continuously, ensuring real-time data collection and analysis.

The increasing focus on personalized medicine is also contributing to the market expansion. Personalized medicine, which tailors treatment plans to individual patient profiles, requires extensive clinical trials to validate the efficacy and safety of new therapies. This trend is driving the need for specialized clinical trial equipment and ancillary solutions that can handle diverse and complex trial protocols. Additionally, regulatory authorities are tightening the guidelines for clinical trials to ensure patient safety and data integrity, necessitating the use of advanced equipment and services to meet these stringent requirements.

Clinical Trial Imaging Service plays a pivotal role in the realm of clinical trials, offering essential diagnostic capabilities that are crucial for assessing the efficacy of new treatments. With the advent of AI-powered imaging technologies, the precision and speed of imaging processes have significantly improved, enabling researchers to obtain detailed insights into patient conditions. This service not only enhances the accuracy of trial outcomes but also facilitates real-time monitoring, thereby improving patient safety and trial efficiency. As the demand for personalized medicine grows, the need for sophisticated imaging services becomes even more pronounced, driving innovation and investment in this area.

From a regional perspective, North America holds the largest market share due to its robust healthcare infrastructure, significant investment in R&D, and the presence of major pharmaceutical and biotechnology companies. However, the Asia Pacific region is expected to witness the highest growth rate during the forecast period. This growth is attributed to the increasing number of clinical trials being conducted in emerging economies like China and India, driven by lower operational costs and a large patient pool. Moreover, the growing awareness about clinical trials and improving healthcare facilities in these countries are further boosting the market growth.

Product Type Analysis

The Clinical Trial Equipment & Ancillary Solutions market is segmented into various product types, including imaging equipment, monitoring devices, lab equipment, and others. Imaging equipment, which includes MRI machines, CT scanners, and X-ray devices, is crucial for diagnosing and monitoring patients in clinical trials. The demand for advanced imaging equipment is increasing due to their ability to provide detailed and accurate images, which are essential for assessing the efficacy of new treatments. Moreover, technological advancements in imaging techniques, such as the development of AI-powered imaging systems, are expected to further drive market growth in this segment.

BackgroundSuicide and suicidal behavior during adolescence have been steadily increasing over the past two decades. The preponderance of interventions focuses on crisis intervention, underlying psychiatric disorders, regulating negative affect, and reducing cognitive distortions. However, low positive affectivity may be a mechanism that contributes to adolescent suicidal ideation and behaviors independent of other risk factors. Skills to Enhance Positivity (STEP) is an acceptance-based intervention, designed to increase attention to, and awareness of, positive affect and positive experiences. Results from a pilot RCT demonstrated engagement of the target (positive affect) and a decrease in clinical outcomes (suicidal events; i.e., either a suicide attempt or an emergency intervention for an acute suicidal crisis), providing support to test the clinical effectiveness of STEP in a larger clinical trial with clinical staff implementing the intervention.ObjectiveTo test the effectiveness of STEP, compared to Enhanced Treatment as Usual (ETAU), in reducing suicidal events and ideation in adolescents admitted to inpatient psychiatric care due to suicide risk. We hypothesize that those randomized to STEP, compared to ETAU, will have lower rates of suicide events, active suicidal ideation (SI), and depressed mood over the 6-month follow-up period. We hypothesize that those randomized to STEP, compared to ETAU, will demonstrate greater improvement in the hypothesized mechanisms of attention to positive affect stimuli and gratitude and satisfaction with life.MethodsParticipants will be randomized to either STEP or ETAU. STEP consists of four in-person sessions focused on psychoeducation regarding positive and negative affect, mindfulness meditation, gratitude, and savoring. Mood monitoring prompts and skill reminders will be sent via text messaging daily for the first month post-discharge and every other day for the following two months. The ETAU condition will receive text-delivered reminders to use a safety plan provided at discharge from the hospital and healthy habits messages, matched in frequency to the STEP group. This trial was registered on 6 August 2021 (ClinicalTrials.gov NCT04994873).ResultsThe STEP protocol was approved by the National Institute of Mental Health (NIMH) Data and Safety Monitoring Board on March 4, 2022. The RCT is currently in progress.DiscussionThe STEP protocol is an innovative, adjunctive treatment that has the potential to have positive effects on adolescent suicidal ideation and attempts beyond that found for standard treatment alone.

The global market for vaso-occlusive crisis (VOC) associated with sickle cell disease (SCD) drugs is experiencing robust growth, driven by increasing prevalence of SCD, rising awareness about treatment options, and ongoing research and development efforts. The market, estimated at $2 billion in 2025, is projected to exhibit a Compound Annual Growth Rate (CAGR) of 15% from 2025 to 2033, reaching an estimated $7.5 billion by 2033. This growth is fueled by several key factors. Firstly, the expanding understanding of SCD pathophysiology and the availability of newer, more effective therapies are driving increased treatment rates. Secondly, a growing number of clinical trials focused on developing innovative therapies for VOC management are further propelling market expansion. Finally, supportive government initiatives and increased healthcare spending in several regions are contributing to improved access to these crucial medications. Segment-wise, the hospital setting currently dominates the application segment, due to the complexity of VOC management requiring specialized medical infrastructure. However, the "others" segment, encompassing home healthcare and ambulatory settings, is expected to witness substantial growth driven by advancements in patient management and increasing preference for decentralized care. Among drug types, Crizanlizumab and other novel therapies are demonstrating significant market traction due to their superior efficacy and safety profiles compared to older treatments. Major players like AstraZeneca, Bristol-Myers Squibb, Gilead Sciences, and Pfizer are actively involved in research, development, and commercialization of VOC treatments, fostering competition and driving innovation. Geographic distribution shows North America commanding a significant share, primarily due to high healthcare spending and a relatively higher prevalence of SCD in the region. However, the Asia-Pacific region is poised for rapid growth, fueled by rising awareness, growing healthcare infrastructure, and expanding access to advanced medical care. Regulatory approvals and pricing policies also significantly influence market dynamics in different regions. The market's continued growth is, however, subject to certain restraints, including the high cost of treatment, limited access to healthcare in developing countries, and potential side effects associated with some therapies. Ongoing research into gene therapy and other novel approaches promises further advancement in managing VOC and is likely to reshape the market landscape in the coming years.

eCOA Market Outlook

The global market size for Electronic Clinical Outcome Assessment (eCOA) is projected to witness significant growth, reaching an estimated value of $2.8 billion by 2023 and forecasted to expand to $6.2 billion by 2032, driven by a compound annual growth rate (CAGR) of 8.5%. This remarkable growth can be attributed to several converging factors, including the increasing demand for efficient clinical trial outcomes, the growing adoption of electronic data capture (EDC) solutions, and the heightened emphasis on patient-centric approaches in the pharmaceutical and biotechnology sectors.

One of the primary growth drivers for the eCOA market is the rising need for improving the accuracy and reliability of clinical trial data. Traditional paper-based methods are increasingly being viewed as inefficient and error-prone, leading to delayed trials and increased costs. The adoption of eCOA solutions mitigates these issues by streamlining data collection processes, enhancing data quality, and reducing the time taken to compile and analyze results. This shift towards digital solutions is particularly evident in the pharmaceutical and biotechnology industries, where timely and accurate data is crucial for regulatory approvals and market entry.

Another significant factor propelling the eCOA market is the regulatory support and guidelines encouraging the use of electronic methods for clinical trials. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been advocating for the use of electronic data capture and patient-reported outcomes to improve trial transparency and efficiency. These endorsements not only instill confidence in the eCOA methodologies but also drive their adoption across various phases of clinical trials, from early-stage research to post-market surveillance.

The COVID-19 pandemic has further accentuated the importance of eCOA solutions. With the global healthcare system under immense pressure, there has been a substantial acceleration in the adoption of remote monitoring and decentralized clinical trials. eCOA platforms facilitate remote data collection, enabling continuous patient monitoring without the need for physical site visits. This not only ensures the safety of both patients and healthcare providers but also supports uninterrupted clinical research during times of crisis. Consequently, the pandemic has acted as a catalyst, underscoring the long-term value and necessity of digital transformation in clinical outcomes assessment.

Regionally, North America holds a dominant position in the eCOA market, driven by advanced healthcare infrastructure, robust research and development (R&D) activities, and significant investment in clinical trials. Europe follows closely, with increasing adoption of digital health technologies and favorable regulatory landscapes. The Asia Pacific region is anticipated to exhibit the highest growth rate, fueled by the burgeoning clinical research sector, growing pharmaceutical industry, and increasing government initiatives to promote healthcare innovation. Latin America, and the Middle East & Africa are also expected to witness steady growth, although at a relatively slower pace due to varied levels of adoption and infrastructure development.

The role of Clinical Literature Improvement in the eCOA market cannot be overstated. As the industry shifts towards more digital and patient-centric methodologies, the need for comprehensive and up-to-date clinical literature becomes paramount. This improvement in clinical literature ensures that stakeholders have access to the latest research findings, methodologies, and best practices, which are crucial for designing effective clinical trials. By enhancing the quality and accessibility of clinical literature, researchers and clinicians can make informed decisions, optimize trial designs, and ultimately improve patient outcomes. This focus on improving clinical literature is aligned with the broader goals of the eCOA market to enhance data accuracy and reliability, thereby supporting the overall growth and innovation within the industry.

Solution Type Analysis

The eCOA market can be segmented by solution type into ePRO (electronic Patient Reported Outcomes), eCOA (electronic Clinical Outcome Assessments), eConsent, eSource, and others. Each of these solutions plays a pivotal role in different aspects of clinical trials and research studies, with ePRO being one of the

These searches were designed constructed between April and May 2020 to support a series of evidence reviews designed to retrieve all potential references for interventions or management strategies to support the resilience and mental health of frontline health and social care staff during a global health crisis and following de-escalation. This series of evidence reviews aim to answer the following questions: 1. What research evidence is there relating to the resilience and mental health of health and social care professionals during, and after, a disease outbreak, epidemic or pandemic? (Stage 1. Scoping review); 2. What are the most effective interventions to support the resilience and mental health of these health and social care professionals, during, and after, a disease outbreak, epidemic or pandemic? (Stage 2a. Cochrane systematic review of evidence of effectiveness); and 3. What are the barriers and facilitators that may impact on the implementation of effective interventions to support the resilience and mental health of these health and social care professionals, during, and after, a disease outbreak, epidemic or pandemic? (Stage 2b. Systematic review of factors affecting implementation). The protocol search strategy was designed for MEDLINE Ovid, and adapted for use in the Cochrane Database of Systematic Reviews (CDSR) and Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, Embase Ovid, Web of Science Indexes, PsycINFO Ovid, CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature), Global Index Medicus databases, the WHO Library Database (WHO IRIS) (Institutional Repository for Information Sharing), US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and Google Scholar using the 2dSearch interface. Each search strategy contains separate search lines and incorporates a combination of uncontrolled vocabulary/keywords and controlled vocabulary terms for (a) resilience and mental health interventions, (b) health and social care personnel, and (c) pandemics, epidemics and health outbreaks. Boolean operators and proximity operators were used to maximise sensitivity and recall where available. Publication date were restricted to publication from 2002 onwards using date limiter functions.

Aims/BackgroundThe mental health challenges faced by frontline healthcare workers responding to emergencies have become a prominent public concern. Despite the consensus that Psychological First Aid (PFA) training can effectively support public mental health during emergencies through reducing acute distress and improving self-efficacy, yet it is concerning that previous flexible delivery and neglect for evaluating PFA training has resulted in unintended potential harms which may prevent further proactive uptake of this mental health prevention strategies. Establishing the feasibility of the PFA training through adapting to the local culture, tailoring to frontline healthcare context, and evaluating systematically may be helpful to inform a large trial, or ensure effective and sustained training delivery. This study aims to present a protocol for evaluating the feasibility and acceptability of a well-adapted PFA training intervention (Preparing Me) to address the implementation gap in this mental health promotion approach.MethodThis is a two-armed feasibility randomized controlled trial (RCT) to be conducted among 80 Chinese frontline healthcare workers without prior related mental health training. Participants from the intervention group will receive an adapted PFA training program tailored to the Chinese frontline context to improve their knowledge and skills to support people in crisis. The primary objectives are to evaluate the training intervention's feasibility and the target population's acceptance of this educational intervention. The secondary objective is to obtain preliminary estimates of variability in participants' outcomes over a 3-months period. Measurements are taken pre-intervention (T0), post-intervention (T1), and at 1- and 3-months follow-up (T2–T3). A process evaluation using qualitative research with a subgroup of trainees, their clinical managers as well as trainers will be conducted to gain a comprehensive understanding of the intervention's acceptability and feasibility.DiscussionThis present study protocol will help to establish whether this adapted PFA training intervention is feasible and accepted by the frontline healthcare workers, in preparation for a later effectiveness trial. It is anticipated that the resulted information would be an impetus to maximize usability and acceptance of this low-intensity PFA skillset by a wider population, thus supporting the mental health of frontline healthcare workers in dealing with crises for future emergencies.Trial RegistrationThis trial has been approved by the Institution Review Board from Central South University (LYG2020029) and by the Psychiatry, Nursing and Midwifery Research Ethics Committee at King's College London, England (LRS/DP-21/22-23161). It also has been processing registration at the Chinese Clinical Trial Registry.

The dataset of this project "Model for Guiding Medical School Strategy during Crisis Using (PACT)™". It included the Zoom recordings

Cases with missing values were discarded from the particular statistical analysis.

Vaso Occlusive Crisis Associated with Sickle Cell Disease Drug Market Outlook 2032

The global vaso occlusive crisis associated with sickle cell disease drug market size was USD 2.04 Billion in 2023 and is likely to reach USD 4.03 Billion by 2032, expanding at a CAGR of 7.9% during 2024–2032. The market growth is attributed to the increasing prevalence of sickle cell disease and advancements in drug therapies targeting vaso-occlusive crises.



High levels of awareness and education regarding sickle cell disease and its management are propelling the market during the assessment year. Initiatives by healthcare organizations, patient advocacy groups, and government bodies aim to educate the public and healthcare professionals about the importance of early diagnosis and appropriate treatment of vaso-occlusive crises. These educational efforts lead to earlier detection and intervention, reducing the burden of complications and improving patient outcomes.

Rising collaborations and partnerships between pharmaceutical companies, research institutions, and healthcare providers is a significant factor in fueling the market. These collaborations foster the exchange of knowledge, resources, and technology, accelerating the development and commercialization of new therapies. Joint efforts in clinical trials, regulatory approvals, and market distribution enhance the efficiency and reach of new treatments.

Impact of Artificial Intelligence (AI) in Vaso Occlusive Crisis Associated with Sickle Cell Disease Drug Market

The use of artificial intelligence is significantly impacting the vaso-occlusive crisis associated with the sickle cell disease drug market by enhancing drug discovery and development processes. AI algorithms analyze vast datasets to identify potential drug candidates efficiently, accelerating the development of targeted therapies. By predicting patient responses to treatments, AI enables personalized medicine approaches, optimizing drug efficacy and reducing adverse effects. Moreover, AI-powered diagnostic tools improve early detection and monitoring of vaso-occlusive crises, facilitating timely intervention and better disease management.

Sickle Cell disease is a genetic disorder that affects millions worldwide, primarily in regions such as Sub-Saharan Africa, India, and the Middle East. It is characterized by the production of abnormal hemoglobin, leading to the distortion of red blood cells into a sickle shape. These sickle-shaped cells can obstruct blood flow, causing severe pain and potential organ damag

Objectives

Despite decades of research using animals to develop pharmaceutical treatments for stroke patients, few therapeutic options exist. The vast majority of interventions successful in preclinical animal studies have turned out to have no efficacy in humans, or to be harmful to humans. In view of this we explore whether there is evidence of a move away from animal models in this field.

Methods

We used an innovative methodology, the analysis of opinion papers. Although we took a systematic approach to literature searching and data extraction, this is not a systematic review because the study involves the synthesis of opinions, not research evidence. Data were extracted from retrieved papers in chronological order and analysed qualitatively and descriptively.

Results

Eighty eligible papers, published between 1979 and 2018, were identified. Most authors were from academic departments of neurology, neuroscience or stroke research. Authors agreed that translational stroke research was in crisis. They held diverse views about the causes of this crisis, most of which did not fundamentally challenge the use of animal models. Some, however, attributed the translational crisis to animal-human species differences and one to a lack of human in vitro models. Most of the proposed solutions involved fine-tuning animal models but authors disagreed about whether such modifications would improve translation. A minority suggested using human in vitro methods alongside animal models. One proposed focusing only on human based in vitro methods.

Conclusion

Despite recognising that animal models have been unsuccessful in the field of stroke, most researchers exhibited a strong resistance to relinquishing them. Nevertheless there is an emerging challenge to the use of animal models, in the form of human focused in vitro approaches. For the sake of stroke patients there is an urgent need to revitalise translational stroke research and explore the evidence for these new approaches.

Methods We used an innovative methodology, the analysis of opinion papers. We took a systematic approach to literature searching and data extraction. Data were extracted from retrieved papers in chronological order and analysed qualitatively and descriptively.

This statistic illustrates the growth in the number of medical apps downloaded in January 2020 compared to the 'peak' month for the COVID-19 crisis in each respective country. South Korea had the highest growth, with a 135 percent increase in such downloads comparing its peak month of the pandemic with January.

This study aimed to comprehensively analyze inflammatory and autoimmune characteristics of patients with sickle cell disease (SCD) at a steady-state condition (StSt) compared to healthy controls (HCs) to explore the pathogenesis of StSt and its impact on patients’ well-being. The study cohort consisted of 40 StSt participants and 23 HCs enrolled between July 2021 and April 2023. StSt participants showed elevated white blood cell (WBC) counts and altered hematological measurements when compared to HCs. A multiplex immunoassay was used to profile 80 inflammatory cytokines/chemokines/growth factors in plasma samples from these SCD participants and HCs. Significantly higher plasma levels of 35 analytes were observed in SCD participants, with HGF, IL-18, IP-10, and MCP-2 being among the most significantly affected analytes. Additionally, autoantibody profiles were also altered, with elevated levels of anti-SSA/Ro60, anti-Ribosomal P, anti-Myeloperoxidase (MPO), and anti-PM/Scl-100 observed in SCD participants. Flow cytometric analysis revealed higher rates of red blood cell (RBC)/reticulocyte-leukocyte aggregation in SCD participants, predominantly involving monocytes. Notably, correlation analysis identified associations between inflammatory mediator levels, autoantibodies, RBC/reticulocyte-leukocyte aggregation, clinical lab test results, and pain crisis/sensitivity, shedding light on the intricate interactions between these factors. The findings underscore the potential significance of specific biomarkers and therapeutic targets that may hold promise for future investigations and clinical interventions tailored to the unique challenges posed by SCD. In addition, the correlations between vaso-occlusive crisis (VOC)/pain/sensory sensitivity and inflammation/immune dysregulation offer valuable insights into the pathogenesis of SCD and may lead to more targeted and effective therapeutic strategies.Clinical Trial RegistrationClinicalTrials.gov, Identifier: NCT05045820.

BackgroundThe COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenges exist in relation to the interplay of the various applicable rules, particularly with respect to compliance with the General Data Protection Regulation (GDPR). This study aimed to gain insights into the experience of key clinical research stakeholders [investigators, ethics committees (ECs), and data protection officers (DPOs)/legal experts working with clinical research sponsors] across the EU and the UK on the main challenges related to data protection in clinical research before and during the pandemic.Materials and methodsThe study consisted of an online survey and follow-up semi-structured interviews. Data collection occurred between April and December 2021. Survey data was analyzed descriptively, and the interviews underwent a framework analysis.Results and conclusionIn total, 191 respondents filled in the survey, of whom fourteen participated in the follow-up interviews. Out of the targeted 28 countries (EU and UK), 25 were represented in the survey. The majority of stakeholders were based in Western Europe. This study empirically elucidated numerous key legal and ethical issues related to GDPR compliance in the context of (cross-border) clinical research. It showed that the lack of legal harmonization remains the biggest challenge in the field, and that it is present not only at the level of the interplay of key EU legislative acts and national implementation of the GDPR, but also when it comes to interpretation at local, regional and institutional levels. Moreover, the role of ECs in data protection was further explored and possible ways forward for its normative delineation were discussed. According to the participants, the pandemic did not bring additional legal challenges. Although practical challenges (for instance, mainly related to the provision of information to patients) were high due to the globally enacted crisis measures, the key problematic issues on (cross-border) health research, interpretations of the legal texts and compliance strategies remained largely the same.