ABSTRACT
IntroductionIn recent years, substantial improvements in clinical trial facilitation have been made through a pan-European network conect4children (c4c), funded by the Innovative Medicines Initiative 2. Within c4c, collaboration and experience-based teaching were attainable due to live meetings and structured social interactions. Since the COVID-19 pandemic, meeting platforms were limited and strictly virtual, creating an artificial communication environment and a gap for young talent to interact and learn.MethodsIn light of c4c's main objective to build strong collaborations and connections between different national clinical trial networks, the younger generation was in need of support. In May 2021, the young investigators community (YIC) platform was launched to facilitate an informal teaching and connecting vehicle. However, interaction with the experienced and leading generation was lacking, in order to mentor the ‘starters' for a durable network.ResultsWithin the first year, the YIC created an open platform in which the 32 members could interact on a regular basis. Topics included involving medical students, how to build and prepare sustainable business plans and working and interacting with industry partners. Inspired by Erasmus+ funded Pathway project and McBride at al (2017) Mentorship profiling, a 4-page intake questionnaire for both mentor and mentee has been designed, that focuses on specific skills and a plan-of-action for the mentorship session, maximizing efficiency of the interaction.ConclusionWithin YIC, a questionnaire was designed to approach mentor and mentee selection, to be used to minimize the gap between young talent and the established community. The method could be beneficial to other national and international network
ABSTRACT
Background & Aims: In early January 2020, a new corona virus called corona was identified as an infectious agent by the World Health Organization and caused a viral pneumonia outbreak, the first of which was reported in Wuhan, China in December 2019. The virus has so far infected most countries in the world and has become a global problem. By this time in December 2021, about 265 million people in the world have been infected with this virus and 5 million 270 thousand people have died from this disease. According to the World Health Organization, the incidence of this disease is still increasing and will become the third leading cause of death in the world by 2030. This disease has a special complexity and has multiple dimensions and consequences that have caused many problems in the field of health, social and economic as well as psychological for people. The emergence of this disease is now a public health crisis. According to this research, exposure to news and restrictions caused by this disease can lead to many mental health problems. In fact, one of the situations that puts a lot of stress on people during the outbreak of covid 19 disease is the inability to predict and uncertainty about the control and end of the disease. Mental health is defined as a harmonious and harmonious behavior with society, recognizing and accepting social realities, the power to adapt to them and meeting one's balanced needs and is an important factor for the health of society. The prevalence of the disease can also increase feelings of loneliness, decrease social support, feelings of fear and anxiety to clinical stress and anxiety, obsessive-compulsive disorder associated with the disease, and decreased life expectancy. One of the hopeful factors is health and the disease can cause despair, fear and even despair of the patient. The outbreak of a disease has a much deeper and wider impact and affects not only the affected community and relatives, but the entire community. Because everyone finds themselves at risk, and therefore people's feel of safe and healthy changes, and this situation causes people to despair. Hope is the capacity to imagine the ability to create paths to desirable goals and to imagine the motivation to move in those paths. Hope predicts physical and mental health such as positive response to medical interventions, mental health, effective getting along, and health-promoting behaviors. Covid 19 disease can also lead to psychological problems due to its infectious nature and unpredictable nature. In this regard, various researchers consider the implementation of public health policies, including areas related to individual and collective mental health in accordance with the different stages of the epidemic of this disease is very necessary. Mindfulness can be an effective tool for achieving peace of mind and body that helps people become aware of their current feelings. Mindfulness-based interventions are considered as one of the third generation or third wave cognitive-behavioral therapies. Mindfulness is a form of meditation rooted in Eastern religious teachings and rituals, especially Buddhism. Segal has defined mindfulness as paying attention to specific and purposeful ways, in the present time, without judgment or prejudice. Linhan stressed for the first time the need to pay attention to mindfulness as one of the essential components of psychological therapy. Mindfulness requires the development of three components: judgment avoidance, purposeful awareness, and focus on the present moment. Focusing on the present and processing all aspects of the above experience makes one aware of the daily activities and automatic functioning of the mind in the past and future world and he controls emotions, thoughts, and physical states through moment-to-moment awareness of thoughts. As a result, it is released from the everyday and automatic mind focused on the past and the future. Although general vaccination has reduced the virus in some countries, including Iran, and reduced the number of infected people, a large num
ABSTRACT
Technology and artificial intelligence, alongside the COVID-19 pandemic vastly increasing technology use in health care, have precipitated an escalation of big data. Although real-world data (RWD) and real-world evidence (RWE) have contributed to determining outcomes outside the scope of randomized clinical trials (RCTs), RWD and RWE are underutilized in demonstrating drug effectiveness. Utilizing RWD may enhance the ability of regulatory agencies to approve drugs, provide drug effectiveness insight to payers, and improve personalized medicine. Additionally, RWD and RWE may assist in overcoming the limitations of RCT data such as treatment adherence and underrepresented patient subgroups and may support and expedite drug repositioning. Even though the limitations of using RWE and RWD include fragmented data context, poor data quality, and information governance, healthcare analytics hubs such as the European Health Data Space are designed to foster synergy among private and public healthcare players and may assist in overcoming these potential limitations. Such healthcare analytics hubs may enhance the utilization of RWE and/or RWD, which could ultimately result in better patient outcomes. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.
ABSTRACT
BackgroundAdvance care planning (ACP) is an iterative communication process about patients' values and preferences for future care. The general practice setting can provide opportunities for ACP, but deficits remain in its initiation due to barriers at the patient, general practitioner (GP), or health care system level. A complex intervention may be necessary to reduce barriers. We aimed to evaluate the effects of a complex ACP intervention for patients with chronic, life-limiting illness in general practice (ACP-GP).MethodCluster-randomized controlled trial with randomization at the GP level. The intervention consists of a patient workbook, GP training, ACP conversations, and a documentation template. Outcomes were the 15-item ACP Engagement Survey for patients and the ACP Self-Efficacy Scale for GPs. Linear mixed models evaluated differences at 3 months (T1, effectiveness evaluation) and 6 months (T2) post-baseline. Analysis was per intention-to-treat.Results35 GPs and 95 patients were randomized. Patient ACP engagement did not differ between the intervention and control group at T1 (baseline-adjusted mean difference, 0.34;95% CI, -0.02 to 0.69;p=0.062) or T2 (baseline-adjusted mean difference, 0.20;95% CI, -0.17 to 0.57;p = 0.28). for GP ACP self-efficacy, there were no significant differences between groups at T1 (baseline-adjusted mean difference, 0.16;95% CI, -0.04 to 0.35;p = 0.11) or at T2 (baseline-adjusted mean difference, 0.11;95% CI, -0.09 to 0.31;p = 0.27).ConclusionACP-GP did not improve patient engagement and GP self-efficacy more than usual care. Both groups showed patterns of increase from baseline. Trial procedures and the COVID-19 pandemic that coincided with the trial may have increased awareness about ACP, which may have also stimulated the control group to conduct more ACP than expected. It may be necessary to also look further at what patients and surrogate decision makers want and need from the ACP process.
ABSTRACT
[...]the journal Nutrition and Food Science has published this special issue exploring the intersection of nutrition and COVID-19 [1], [2], [3], [4], [5], [6], [7], [8]. [...]a study explored the factors related to sedentary lifestyle in a Brazilian sample during the COVID-19 initial quarantine [8]. [...]the papers published in the special issue "The relationship between nutrition and COVID-19” underlined the importance of nutrition in mitigating the mental and health-related impacts of the COVID-19 pandemic.
ABSTRACT
[...]the mortality reduction has previously been reported in the prospective meta-analysis [2] conducted by The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group. Nonetheless, owing to relatively scarce evidence, it is still unclear whether monoclonal IL-6 antibodies reduce mortality in patients with COVID-19, similar to the IL-6 receptor inhibitors. [...]large-scale randomised trials should also be conducted to establish the role of monoclonal IL-6 antibodies in the treatment of COVID-19. [...]among hypothetical long-term complications, peripheral neuropathy would also be noticeable [10] and may contribute to the broad long COVID pattern. [...]there is a theoretical risk of altering the efficacy of immune checkpoint inhibitors during tumour disease management [11].
ABSTRACT
PurposeToday, coronavirus disease-19 (COVID-19) treatment is an evolving process, and synbiotic administration has been suggested as a new therapeutic strategy. This study aims to investigate the effect of synbiotic supplementation in COVID-19 patients.Design/methodology/approachIn this placebo-controlled trial, 80 patients were randomized to receive oral synbiotic capsule (containing fructooligosaccharide and seven bacterial strains;Lactobacillus (L) casei, L. rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, L. acidophilus, Bifidobacterium longum, L. bulgaricus, each one 109 colony-forming units) or placebo for two months. Inflammatory markers (Interleukin-6 [IL-6], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]) and white blood cell (WBC) count were evaluated at two timepoints (baseline, two months later). The measured variables were adjusted for confounders and analyzed by SPSS v21.0.FindingsAll 80 enrolled patients completed the study. The study adherence was good (approximately 70%). The mean changes for IL-6 were not significant (Δ = −0.6 ± 10.4 pg/mL vs Δ = +11.2 ± 50.3 pg/mL, p > 0.05). There were no significant improvements for CRP, ESR and WBC.Originality/valueAdministration of synbiotics for two months did not improve inflammatory markers in COVID-19 patients.
ABSTRACT
PURPOSE: This qualitative study aimed to understand the impact of the coronavirus disease 2019 pandemic from March to November 2020 on healthcare delivery and clinical trials for genitourinary (GU) cancers in Australia. METHODS: Annually a pre-conference workshop is hosted by the Australian New Zealand Urogenital and Prostate Cancer Trials Group for supportive care health professionals. In November 2020, those that selected to attend were invited to participate in a focus group. Workshop and focus group discussions were recorded and transcripts were analyzed thematically. RESULTS: Seventy-two individuals involved in GU cancer care and clinical trials took part. Participants described negative changes to GU cancer care and clinical trials from the pandemic due to reduced clinical services and increased wait times. Trial recruitment was paused temporarily during lockdowns, and standard treatment protocols were used to limit hospital visits. Trial process changes included electronic capture of informed consent, home delivery of oral medications, and delegations of assessments. These changes increased administrative activity for clinical trial teams and Human Research Ethics Committees. A transition to telehealth enabled continuity of service delivery and trials but reduced the opportunity for face-to-face patient consultations with increasing concern about the failure to detect supportive care needs. CONCLUSION: The pandemic has prompted a critical review of service delivery and clinical trials for people with GU cancers.
ABSTRACT
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) have been leaders in protecting and promoting the U.S. public health by helping to ensure that safe and effective drugs and biological products are available in the United States for those who need them. The null hypothesis significance testing approach, along with other considerations, is typically used to demonstrate the effectiveness of a drug or biological product. The Bayesian framework presents an alternative approach to demonstrate the effectiveness of a treatment. This article discusses the Bayesian framework for drug and biological product development, highlights key settings in which Bayesian approaches may be appropriate, and provides recent examples of the use of Bayesian approaches within CDER and CBER.
ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic indirectly resulted in missed therapeutic opportunities for many diseases. Here we focus on community-acquired respiratory viruses other than severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) [respiratory syncytial virus, parainfluenza and influenza A], and highlight the pandemics impact on clinical trials to develop novel therapies for other severe respiratory viral infections. We retrospectively reviewed inclusion rates within respiratory antiviral clinical trials in comparison with all other clinical trials in our clinical investigations center, before and during the COVID-19 pandemic. As opposed to the remaining clinical trials developed within our unit, respiratory antiviral trials inclusion rates did not recover after the initial recruitment decrease observed across all trials during the first pandemic wave. These results were discussed in the context of non-COVID-19 respiratory viral infection rates within our center, showing a general decline in seasonal respiratory viruses spread since the COVID-19 pandemic onset. Virus epidemiology changes upon the wide SARS-CoV-2 expansion as well as the lifestyle changes globally adopted to prevent SARS-CoV-2 transmission could have therefore contributed to the negative impact of the COVID-19 pandemic on antiviral drug development. Our study highlights the peculiarity of respiratory antiviral drug development during the COVID-19 pandemic era and describes potential explanations for such drug development halting.
ABSTRACT
The deficiently designed and conducted initial clinical development plan and the occurrence of thrombotic thrombocytopenia cases, have marked the 12-month journey of the AstraZeneca coronavirus disease 2019 (COVID-19) vaccine after it was first administered to humans. When it was authorized, there were no available efficacy data in the elderly. However, this age group was included in the product labelling based on immunogenicity data. The lack of safety and efficacy data in the elderly that was acknowledged in the product information, triggered most European Union (EU) countries to limit the administration of this vaccine to certain age groups. In February-March/2021, after the results of observational studies supported the vaccine effectiveness in the elderly, several countries broadened its use to this age group. When trust on the vaccine was ramping up, unusual blood clot cases were described in Europe, which led 24 countries around the world to temporarily halt its administration. These cases were first described as thrombotic thrombocytopenia in late March. In mid-April, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) updated the product information and confirmed the positive benefit/risk ratio of the vaccine, recommending its use with no age restrictions. The World Health Organization (WHO) coincided with this approach. However, several countries decided to limit its use to certain age groups. The EMA listed thrombotic thrombocytopenia as a "very rare" adverse reaction. Although, the AstraZeneca vaccine was conceived in early 2020 to be a worldwide leader in the fight against COVID-19, its use was abandoned by the African Union, Denmark, and Israel. However, this vaccine has shown its usefulness in many settings across the world.
ABSTRACT
Amyotrophic lateral sclerosis (ALS) is a rare, progressive multi-system neurodegenerative disorder. Its clinical presentation varies considerably leading to delays in diagnosis, which has dire consequences in a disease where early intervention is key to optimize outcomes and limit care giver burden. There are a range of diagnostic criteria available to aid ALS diagnosis, as well staging methods to assess disease progression. However, they all suffer from inter-rater variability, complexity, and confusion in use. Such difficulties, when medical appointment times are limited and becoming more virtually based, have the potential to amplify uncertainty and errors in ALS diagnosis and prognosis. This review provides a clinical overview of the best way to balance the needs of evidence-based medicine and the patient. We focus on ALS diagnostic criteria and staging systems currently in use in clinical practice and explore factors that could enhance diagnostic efficiency and assessment of disease progression.
Subject(s)
Amyotrophic Lateral Sclerosis , Humans , Amyotrophic Lateral Sclerosis/diagnosis , Disease ProgressionABSTRACT
Alcohol-related hepatitis (ARH) is a unique type of alcohol-associated liver disease characterized by acute liver inflammation caused by significant alcohol use. It ranges in severity from mild to severe and carries significant morbidity and mortality. The refinement of scoring systems has enhanced prognostication and guidance of clinical decision-making in the treatment of this complex disease. Although treatment focuses on supportive care, steroids have shown benefit in select circumstances. There has been a recent interest in this disease process, as coronavirus disease 2019 pandemic led to substantial rise in cases. Although much is known regarding the pathogenesis, prognosis remains grim due to limited treatment options. This article summarizes the epidemiology, genetics, pathogenesis, diagnosis and treatment of ARH.
Subject(s)
COVID-19 , Hepatitis, Alcoholic , Liver Diseases, Alcoholic , Humans , Hepatitis, Alcoholic/diagnosis , Hepatitis, Alcoholic/epidemiology , Hepatitis, Alcoholic/therapy , Prognosis , Steroids/therapeutic useABSTRACT
Autoimmune hemolytic anemia (AIHA) is defined by increased erythrocyte turnover mediated by autoimmune mechanisms. While corticosteroids remain first-line therapy in most cases of warm-antibody AIHA, cold agglutinin disease is treated by targeting the underlying clonal B-cell proliferation or the classical complement activation pathway. Several new established or investigational drugs and treatment regimens have appeared during the last 1-2 decades, resulting in an improvement of therapy options but also raising challenges on how to select the best treatment in individual patients. In severe warm-antibody AIHA, there is evidence for the upfront addition of rituximab to prednisolone in the first line. Novel agents targeting B-cells, extravascular hemolysis, or removing IgG will offer further options in the acute and relapsed/refractory settings. In cold agglutinin disease, the development of complement inhibitors and B-cell targeting agents makes it possible to individualize therapy, based on the disease profile and patient characteristics. For most AIHAs, the optimal treatment remains to be found, and there is still a need for more evidence-based therapies. Therefore, prospective clinical trials should be encouraged.