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Trained Scent Dogs Can Quickly and Accurately Detect Covid-19

MedicalResearch.com Interview with: Prof. Tommy Dickey Ph.D. Distinguished Professor Emeritus Geography Department University of California Santa Barbara Santa Barbara, CA

MedicalResearch.com: What is the background for this study? Response:  I became interested in dog's sense of smell several years ago while doing therapy dog demonstrations at the California Science Center in Los Angeles during a special traveling exhibit "Dogs! A Science Tail." (Now at the Orlando Science Center).  I did a lot of research on this topic and taught children about it through the Los Angeles Public Library using my Great Pyrenees therapy dogs. Then, COVID broke out and I expanded my research into any work being done to possibly utilize scent dogs for screening and testing for COVID.  I found only a few such studies.  However, I fortuitously met Heather Junqueira of BioScent, Inc. (in Florida) online and she was beginning to successfully teach her beagles to detect COVID-related odors.  She agreed to co-author a peer-reviewed review paper with me.  That led to our first paper - Dickey, T, Junqueira, H. Toward the use of medical scent dogs for COVID-19 screening. J Osteopath Med 2021;1(2): 141-148. https://doi.org/10.1515/jom-2020-0222 When the COVID pandemic began to wane at the beginning of this year, I felt that it would be the perfect time to do this comprehensive follow-up review to see how far COVID scent dog research had progressed. To our amazement, research efforts had increased by almost tenfold and involved over 400 scientists using over 31,000 samples (including sniffings) from over 30 countries and that 29 peer reviewed papers had been published. Heather’s inspiration for doing scent dog work came when her father contracted cancer and she wanted to find better diagnostics.  She has since been successful in detecting non-small cell lung cancer with her trained beagles as well as COVID. MedicalResearch.com: Would you tell us a little about the type and/or breeding of the dogs? Response:  In the peer-reviewed studies, the number of different breeds and mixed breeds was 19.   Typical training periods dedicated to COVID scent detection were a few weeks. Labrador Retrievers and Belgian Malinois were most commonly used (nearly 100 times). These breeds were chosen because they have been used extensively in scent detection work for several purposes.  Other breeds, such as Heather’s beagles, have been used quite successfully as well. No obvious preference based on performance has been noted by breed, age, gender, age or even previous training for scent work. Interestingly, most of the dogs were not specifically bred to do COVID detection.  In fact, previously untrained dogs have the advantage that they are not as prone to indicating on scents other than the COVID-19 associated scent. Heather is one of the few scientists who actually breeds her dogs to be single purpose scent dogs (i.e., for COVID or other diseases). MedicalResearch.com: What are the main findings? 1)    Our review has shown that it safe to utilize scent dogs to directly screen and test individuals who may be infected with the COVID-19. 2)    The accuracy of the trained scent dog method is comparable to or in some cases superior to the real-time reverse transcription polymerase chain reaction (RT-PCR) test and the antigen (RAG) test. 3)    Trained scent dogs can be effectively used to provide quick (seconds to minutes), non-intrusive, and accurate results in public settings and thus reduce the spread of COVID. MedicalResearch.com: What should readers take away from your report? - Medical scent dogs deserve their place as a serious diagnostic methodology that could be particularly useful during pandemics, potentially as part of rapid health screenings in public spaces. We are confident that scent dogs will be useful in detecting a wide variety of diseases in the future. - We feel that the impressive international COVID scent dog research described in our paper, perhaps for the first time, demonstrates that medical scent dogs are ready for mainstream medical applications.  MedicalResearch.com: What recommendations do you have for future research as a results of this study? 1)    More studies utilizing more dogs would be beneficial 2)    More work in developing target samples is needed 3)    More research is needed in different public settings. MedicalResearch.com: Is there anything else you would like to add? Any disclosures? - More trained dogs will be needed for wide-spread, large-scale scent dog screening and testing.   The training and field use of scent dogs may benefit from the recruitment of dog owners who are already involved in recreational scent work under the auspices of the American Kennel Club and other organizations worldwide. - Is the use of scent dogs cost effective?  Much of the research in this review was in fact motivated by the need for rapid, inexpensive, and lower technological testing in developing nations.  More research into the economics is needed. - Perhaps the greatest challenge to the use of medical scent dogs is the implementation of wide-spread, large-scale programs, which will require funding and development of infrastructure that is responsible for certification, protocol standards, and deployments. This may be more of a challenge in the U.S. for a variety of bureaucratic reasons. Other nations face a variety of obstacles, but the large number of scent dogs already used in practical applications (seen in our paper’s References and Tables) suggests that their governments are quite supportive of the common use of medical scent dogs and may not place as many governmental barriers. Citation: Dickey, Tommy and Junqueira, Heather. "COVID-19 scent dog research highlights and synthesis during the pandemic of December 2019−April 2023"��Journal of Osteopathic Medicine, 2023. https://doi.org/10.1515/jom-2023-0104 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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TUFT's GEMINI Study Finds Whole Genomic Sequencing Identifies More Pathogenic Genes than Targeted Panels

MedicalResearch.com Interview with:

Dr. Davis Prof. Jonathan Davis, MD, Chief of Newborn Medicine Tufts Medical Center and

Dr. Maron   Jill Maron, MD, MPH Chief of Pediatrics Executive Director, Mother Infant Research Institute Vice Chair, Pediatric Research, Tufts Medical Center Women & Infants Hospital of Rhode Island   MedicalResearch.com: What is the background for this study? Response: The Genomic Medicine for Ill Neonates and Infants (GEMINI) trial was designed to be the first comparative study to explore the diagnostic yield, clinical utility and time to diagnosis between whole genomic sequencing (WGS) and a targeted genomic sequencing panel specifically designed to detect gene disorders that present in early life. GEMINI was a US based study that enrolled 400 hospitalized infants, along with their available parents, suspected of having an undiagnosed genetic diagnosis. Every participant underwent testing on each platform simultaneously, allowing us to better understand the limitations and advantages of each approach. MedicalResearch.com: What are the main findings? Response:  GEMINI found that genomic sequencing technologies were able to identify at least one pathogenic, likely pathogenic, or highly suspicious VUS in 51% of enrolled patients < 1 year of life. These diagnostic yields are comparable to other recently reported studies (range 25-50%). However, while the targeted test returned results sooner than whole genomic sequencing (6 days vs. 3 days), WGS had nearly double the diagnostic yield (49% v 27%). Thus, in these high-risk infants suspected of having a genetic disorder, WGS was >10 times more likely to make a diagnosis compared to the targeted test. This disparity is partly due to the large number of infants who were found to have structural variants not detected by the targeted test and/or gene variants not currently included on the targeted test.  MedicalResearch.com: What should readers take away from your report? Response: There were many aspects to the GEMINI study that made it unique. Not only was it the first study to perform a comparative analysis of the diagnostic yield, clinical utility, and time to diagnosis between WGS and a targeted neonatal genomic sequencing test, but it also included detection of a suspicious VUS in calculating diagnostic yield. A suspicious VUS was defined as a variant found in a gene suspected of causing the presenting phenotype and was reported to the clinical care team to inform medical management. In a number of these cases, care was modified based on this reporting. Most importantly, when both tests detected the same genetic variant, their interpretation on the importance of the findings were different 40% of the time. MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: The broad Inclusion criteria in GEMINI reinforced our lack of understanding of early life presentation of many genetic diseases. GEMINI identified 134 novel variants among infants < 1 year of age and the ultimate diagnosis was only suspected by consulting geneticists 33% of the time. Many variants detected by WGS were not identified by the targeted test and would not have been detected even if whole exome sequencing had been performed. The overall result of these data suggest that WGS has a higher diagnostic yield in these high risk populations. It should also be noted that surveyed clinicians highly valued access to these genetic platforms, even if a diagnosis was not made. GEMINI did highlight differences in variant classification that can occur between laboratories despite having access to the same clinical and phenotypical data for interpretation. Clinicians need to be cognizant that it is the interpretation of the genome that drives diagnostic rates, not simply the sequencing. Thus, a negative report by one laboratory may not be recapitulated by another. GEMINI serves as a reminder that while our technology has streamlined the pipeline from sequencing to variant call, much work remains on how to best standardize the interpretation of the genome to better inform clinical care. MedicalResearch.com: Is there anything else you would like to add? Any disclosures? Response: This study strongly supports the position that Medicaid and Commercial Insurance carriers should cover WGS (whose costs are decreasing as the technology improves). The early diagnosis should also open tremendous opportunities for industry to develop many other novel genomic approaches to successfully treat many genetic disorders, many of which are currently fatal. All disclosures are listed in the JAMA article.   Citation: Maron JL, Kingsmore S, Gelb BD, et al. Rapid Whole-Genomic Sequencing and a Targeted Neonatal Gene Panel in Infants With a Suspected Genetic Disorder. JAMA. 2023;330(2):161–169. doi:10.1001/jama.2023.9350 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Multiple Gut Bacteria Associated with Atherosclerosis

MedicalResearch.com Interview with:

Dr. Tove Fall Tove Fall, PhD Professor in Molecular Epidemiology Department of Medical Sciences, Molecular Epidemiology Uppsala University Uppsala, Sweden   MedicalResearch.com: What is the background for this study? Response: It is unclear if and how the gut microbiome affect the risk of myocardial infarction. In this study we assessed the association of the gut microbiome measured at high resolution with atherosclerosis, the main underlying pathology of myocardial infarction, in over 8000 participants without any previous cardiovascular events. MedicalResearch.com: What are the main findings? Response: We found 64 species that were associated with atherosclerosis levels. Several of these bacterial species were streptococci, which were in turn also associated with markers of inflammation and specific metabolites. MedicalResearch.com: What should readers take away from your report? Response: There seems to be a clear association of certain gut species with atherosclerosis, but more studies are needed to determine causality and the mechanisms of action. Our results point to a role or streptococci in atherosclerotic disease, but this needs verification in other studies. MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: It is important to account for differences in diet and medication in any microbiome-disease study. Also, a high resolution mapping of the microbiome as in our study helps to identify specific species as different species in the same family of bacteria may have different effects Disclosure Some authors are employed by the company Clinical Microbiomics, which analyzes microbiome samoles. Citation: Streptococcus Species Abundance in the Gut Is Linked to Subclinical Coronary Atherosclerosis in 8973 Participants From the SCAPIS Cohort Sergi Sayols-Baixeras, PhD, Koen F. Dekkers, MSc, Gabriel Baldanzi, MD, Daniel Jönsson, DDS, PhD, Ulf Hammar, BSc, Yi-Ting Lin, MD, PhD, Shafqat Ahmad, PhD, Diem Nguyen, PhD, Georgios Varotsis, DVM, Sara Pita, MSc, Nynne Nielsen, MSc, Aron C. Eklund, PhD, Jacob B. Holm, PhD, H. Bjørn Nielsen, PhD, Ulrika Ericson, PhD, Louise Brunkwall, PhD, Filip Ottosson, PhD, Anna Larsson, MD, Dan Ericson, DDS, PhD, Björn Klinge, DDS, PhD, Peter M. Nilsson, MD, PhD, Andrei Malinovschi, MD, PhD, Lars Lind, MD, PhD, Göran Bergström, MD, PhD, Johan Sundström, MD, PhD, Johan Ärnlöv, MD, PhD, Gunnar Engström, MD, PhD, J. Gustav Smith, MD, PhD, Marju Orho-Melander, PhD, Tove Fall, DVM, PhD Originally published 12 Jul 2023https://doi.org/10.1161/CIRCULATIONAHA.123.063914 Circulation. 2023;0 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Researchers Investigate Psychedelic Effects of THC-O-acetate

MedicalResearch.com Interview with:

Jessica Kruger PhD Clinical Associate Professor of Community Health and Health Behavior University at Buffalo School of Public Health and Health Professions MedicalResearch.com: What is the background for this study? Response: The 2018 Farm Bill authorizing hemp production led to new cannabinoids in the consumer marketplace. As the market becomes increasingly saturated with suppliers, companies continually diversify available products. The rapid emergence of novel cannabinoids outpaces systematic research necessary to inform regulations and harm reduction. Empirical evidence is needed to guide policies, practices, and education of consumers. Product manufacturers, social media participants, and cannabis oriented on-line news sources have claimed that THC-O-acetate is a "psychedelic" cannabinoid, producing experiences similar to those associated with LSD, psilocybin, mescaline, and DMT. MedicalResearch.com: What are the main findings? Response:  We did not find evidence to support the claim of psychedelic effects. Participants reported a low to moderate level of cognitive distortions (altered sense of time, difficulties concentrating, difficulties with short-term memory) and few visuals or hallucinations. Participants completed items from the Mystical Experience Questionnaire (MEQ), a common assessment for psychedelic experiences. Responses were significantly below the threshold for a complete mystical experience on all four MEQ dimensions. Participants who had used classic (5-HT2A agonist) psychedelics had lower scores on all MEQ dimensions than those who had never used classic psychedelics. When asked directly, 79% responded that using  THC-O-acetate is “not at all” or “a little” of a psychedelic experience. MedicalResearch.com: What should readers take away from your report? Response: THC-O-acetate produces effects similar to those of THC, though possibly with a longer latency. As cannabis markets expand, companies will continue to use novel means and claims to promote interest in new products. There is currently no systematic process of verification, or anything approaching the clinical trials that are required for pharmaceutical drugs. Consumers should inform themselves regarding cannabis products, however information is often lacking due to the scarcity of research in this area. MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: Systematic research is needed to examine the properties of novel cannabinoids and verify claims in order to properly guide consumers and protect public health.   There was no funding for this study, we have no conflicts of interest. Citation: THC-O-Acetate: Scarce Evidence for a Psychedelic Cannabinoid Daniel J. Kruger , Ph.D, Carlton CB Bone , M.S, Meredith C. Meacham , Ph.D., M.P.H, Charles Klein , J.D., Ph.D & Jessica S. Kruger , M.S.H.E., Ph.D Received 11 Mar 2023, Accepted 09 Jun 2023, Published online: 29 Jun 2023 https://doi.org/10.1080/02791072.2023.2230573 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Cornell Scientists Make Progress Toward Male Contraception

MedicalResearch.com Interview with: Melanie Balbach PhD Postdoctoral Associate in Pharmacology Weill Cornell Medicine MedicalResearch.com: What is the background for this study? Response: For men, the only two options for birth control currently available are condoms and vasectomy. Additional contraceptive methods are required to more equally distribute the burden of contraception between men and women. We aim to develop an on-demand contraceptive pill for men where sperm motility and thereby fertility is only blocked for multiple hours. The idea is that men take our contraceptive shortly before intercourse and regain fertility about 24 hours later. MedicalResearch.com: What should readers take away from your report? Response: Soluble adenylate cyclase (sAC) is an enzyme that converts ATP to cAMP. cAMP and thereby sAC are crucial for sperm motility and the maturation process sperm undergo in the female genital tract to gain fertilization competence. sAC is like the “on-switch” of sperm and is activated once sperm are ejaculated, male mice that lack sAC are immotile and infertile. Since sAC is so crucial for sperm function and fertility we chose it as our contraceptive target. With this study we provide the proof-of-principle in mice that on-demand, reversible male contraception via inhibition of sAC is possible. When injecting male mice with sAC inhibitor sperm were immotile 30 min later and for the following 2 hours the males remained infertile. 24 hours later the males regained fertility.  MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: As next steps we will test our inhibitors in a second animal model and will further refine our preclinical drug candidates for first clinical trials in humans. Citation: Balbach, M., Rossetti, T., Ferreira, J. et al. On-demand male contraception via acute inhibition of soluble adenylyl cyclase. Nat Commun 14, 637 (2023). https://doi.org/10.1038/s41467-023-36119-6 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Stroke: Thrombectomy Improved Functional Outcomes Overall and Across Different Subgroups

MedicalResearch.com Interview with:

Dr. Sarraj Amrou Sarraj, MD FAHAProfessor of Neurology, Case Western Reserve University School of MedicineGeorge M. Humphrey II Endowed Chair, University Hospitals Neurological Institute Director, Comprehensive Stroke Center and Stroke Systems, University Hospitals MedicalResearch.com: What is the background for this study? What are the main findings? Response: Endovascular thrombectomy was proven safe and effective in patients with acute ischemic, stroke, neurologist, occlusion presenting up to 24 hours from last known well in multiple clinical trials. Patients with large ischemic changes were largely excluded from those trials, and thus limited randomized evidence of thrombectomy in this patient population exists. Our study found that thrombectomy improved the odds of achieving better functional outcomes by 1.5 times in patients with large ischemic changes on non-contrast CT or perfusion imaging. Proportion of patients achieving functional independence (mRS 0-2) and Independent ambulation (mRS 0-3) were also significantly higher with thrombectomy. Symptomatic hemorrhage occurred in very few patients and was not higher with thrombectomy. Results from analyses of subgroup based on clinical and imaging characteristics were also largely similar to those of primary analysis. MedicalResearch.com: What should readers take away from your report? Response: We observed that thrombectomy improved functional outcomes overall and across different subgroups in patients from North America, Europe and Australia and New Zealand. With available results of RESCUE Japan LIMIT trial showed better rates of independent ambulation in patients with large ischemic strokes and ANGEL ASPECT trial in China, I believe we have enough evidence to support thrombectomy procedure in this patient population. MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: Endovascular thrombectomy has been proven one of the most effective treatment in the history of medicine. With the results of our trial, one more frontier has been conquered to extend the treatment to thousands of patients with larger strokes who may benefit. Optimization of health care systems and enhancing thrombectomy delivery should be a priority to offer this potent intervention to more patients. Optimization of patients' care post thrombectomy, care transition and rehabilitations delivery would be vital to improve patients' outcomes. MedicalResearch.com: Is there anything else you would like to add? Any disclosures? Response: SELECT and SELECT2 trials were investigator-initiated studies funded by research grants from Stryker Neurovascular to University Hospitals Cleveland Medical Center and UT McGovern Medical School. In addition, Dr Sarraj was an advisory board and speaker bureau member for Stryker Neurovascular and an advisory board member for AstraZeneca. Citation: Trial of Endovascular Thrombectomy for Large Ischemic Strokes A. Sarraj, A.E. Hassan, M.G. Abraham, S. Ortega‑Gutierrez, S.E. Kasner, M.S. Hussain, M. Chen, S. Blackburn, C.W. Sitton, L. Churilov, S. Sundararajan, Y.C. Hu, N.A. Herial, P. Jabbour, D. Gibson, A.N. Wallace, J.F. Arenillas, J.P. Tsai, R.F. Budzik, W.J. Hicks, O. Kozak, B. Yan, D.J. Cordato, N.W. Manning, M.W. Parsons, R.A. Hanel, A.N. Aghaebrahim, T.Y. Wu, P. Cardona‑Portela, N. Pérez de la Ossa, J.D. Schaafsma, J. Blasco, N. Sangha, S. Warach, C.D. Gandhi, T.J. Kleinig, D. Sahlein, L. Elijovich, W. Tekle, E.A. Samaniego, L. Maali, M.A. Abdulrazzak, M.N. Psychogios, A. Shuaib, D.K. Pujara, F. Shaker, H. Johns, G. Sharma, V. Yogendrakumar, F.C. Ng, M.H. Rahbar, C. Cai, P. Lavori, S. Hamilton, T. Nguyen, J.T. Fifi, S. Davis, L. Wechsler, V.M. Pereira, M.G. Lansberg, M.D. Hill, J.C. Grotta, M. Ribo, B.C. Campbell, and G.W. Albers, for the SELECT2 Investigators* This article was published on February 10, 2023, at NEJM.org. DOI: 10.1056/NEJMoa2214403 https://www.nejm.org/doi/pdf/10.1056/NEJMoa2214403 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Georgetown Study Finds Medical Malpractice Is Not Random

MedicalResearch.com Interview with:

David A. Hyman, JD, MD The Scott K. Ginsburg Professor of Health Law & Policy Georgetown University Law Center Washington, DC MedicalResearch.com: What is the background for this study? Response: Many doctors believe medical malpractice claiming is effectively random — meaning good doctors are equally likely as bad doctors to end up being the target of a malpractice claim.  Past research has studied whether physicians with 2 paid claims are likely to have another claim than doctors with 1 paid claim. We study whether physicians with 1 paid claim are more likely to have another paid claim, compared to physicians with zero paid claims.  We also compare the pattern of observed claims with what we would expect to find if claiming were truly random (by running a simulation). MedicalResearch.com: What are the main findings? Response:  Physicians with a single paid claim are 4x as likely to have a future claim than physicians with zero paid claims.  We find a similar pattern in both high-risk and lower-risk specialties.  We also find no evidence that public disclosure of paid claims has any impact on these patterns — meaning there is no “blood in the water” effect.    MedicalResearch.com: What should readers take away from your report? Response: Medical malpractice is not random. MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: We suggest further research on how to intervene with physicians to prevent future claims and harm to patients. Citation: Hyman DA, Lerner J, Magid DJ, Black B. Association of Past and Future Paid Medical Malpractice Claims. JAMA Health Forum. 2023;4(2):e225436. doi:10.1001/jamahealthforum.2022.5436 https://jamanetwork.com/journals/jama-health-forum/fullarticle/2801227 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Factors Influencing COVID-19 Vaccine Hesitancy in Eastern Pennsylvania

MedicalResearch.com Interview with:

Kenya Colvin Kenya Colvin, MBS Department of Medical Education Scranton, PA MedicalResearch.com:  What is the background for this study?  Response: Vaccine hesitancy is a major driver of COVID-19 vaccination disparities between minority and non-Hispanic White communities. Our goal was to understand what factors influenced vaccine hesitancy among individuals in Eastern Pennsylvania to identify more effective ways to promote vaccine uptake within minority communities. MedicalResearch.com:  What are the main findings? Response: We found that the most influential factors on vaccine hesitancy were being younger than 45 years old, identifying as a minority, being concerned the COVID-19 vaccine was ineffective, lack of knowledge about the vaccine, and believing that infection with the COVID-19 virus is not serious. However, unlike similar studies, our analysis indicated that education level was not a significant contributor to hesitancy.  MedicalResearch.com: What should readers take away from your report? Response: The COVID-19 vaccines are an effective preventive measure in minimizing risk of complications from the continually evolving COVID-19 virus. Understanding why African American and Hispanic communities are more hesitant toward receiving COVID-19 vaccines and boosters is critical to reducing the COVID-19 related health disparities, such as increased risk of death or hospitalization, faced by these communities. MedicalResearch.com: What recommendations do you have for future research as a result of this work? Response: Our study contained a large proportion of vaccine acceptant and non-Hispanic White participants. To better understand the drivers of vaccine hesitancy among minority communities, a more targeted approach should be used to increase participation from vaccine hesitant, minority community members. Citation: Colvin et al. Profiles of COVID-19 vaccine hesitancy by race and ethnicity in eastern Pennsylvania. PLoS One 2023; 18(2):e0280245. https://pubmed.ncbi.nlm.nih.gov/36745588/ The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website. Read the full article

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Toddlers Who Lack Attention to Mother's Speech More Likely to Be Diagnosed with Autism

MedicalResearch.com Interview with:

Dr. Pierce Karen Pierce, Ph.D. Professor, Department of Neurosciences, UCSD Co-Director, Autism Center of Excellence, UCSD MedicalResearch.com: What is the background for this study? Response: The mean age of ASD diagnosis and eventual treatment remains at ~52 months in the United States1 - years beyond the disorder’s prenatal origins2, and beyond the age when it can be reliably diagnosed in many cases3. Currently the only way to determine if a child has autism spectrum disorder (ASD) is to receive a developmental evaluation from an experienced clinician (usually a licensed clinical psychologist). There are often long waiting lists, and only a small number of clinicians have the experience required to make early-age (i.e., between 12-36 months) diagnoses of ASD. Thus, there are many places in the country as well as world wide wherein children wait months or years to receive a formal diagnosis due to a lack of available expertise. Moreover, diagnostic evaluations are expensive and usually cost the parent and/or insurance approximately ~$2,000 or more per evaluation.  Finally, clinical evaluations usually take between 2-3 hours to complete and result in fatigue for both the parent and toddler. Eye-tracking, which generates biologically-relevant, objective, and quantifiable metrics of both visual and auditory preference profiles in babies and toddlers in just minutes, is a technology that can dramatically change how ASD is diagnosed. MedicalResearch.com: What are the main findings?

Response:  A brief summary of the findings of our study is as follow: almost all of the toddlers who participated in an eye tracking study who showed low levels of attention to motherese speech received a diagnosis of autism from a clinical psychologist who was blind to their eye tracking results.  This is a notable finding because each eye tracking test can be completed in about a minute. A more detailed and comprehensive summary of our study is as follows:  653 toddlers aged 1 to 3 years old participated in an eye tracking study. Toddlers were presented with two videos on a screen: one of a woman speaking in motherese, and one non-human scene (either a busy highway or a movie of abstract shapes and numbers with accompanying electronic music). The videos were available for one minute, and the toddlers used their eyes to control which video played at a given time. If any given toddler looked at the actress speaking in motherese less than 30% of the time, the probability that they would receive a diagnosis of autism from a licensed clinical psychologist blind to their eye tracking score was 94%. Findings also showed that the toddlers that attended to motherese speech less than 30% of the time also had more challenges with speaking, cognition and social behavior, pointing to the importance of attending to human speech during early development. It is important to note that only about a third of children who received a diagnosis of autism ‘failed’ the motherese eye tracking test, highlighting that eye tracking can detect a special subtype of ASD.  In this case, the subtype are children who shy away from attending to speech. This is one of the only studies to use ‘gaze contingent’ eye tracking technology which allows the toddler to control what movie they saw, giving us great insight into what interests them. Finally, it is important to note that there were many toddlers who received a diagnosis of autism from a psychologist who ‘passed’ the motherese eye tracking test.  These toddlers tended to have better language and social behavior and highlights the fact that eye tracking can shed light on a both a toddlers strengths as well as their weaknesses and may be a particularly powerful tool for predicting a child’s clinical course.  MedicalResearch.com: What should readers take away from your report? There are 2 key take aways from this research: - If a toddler between 12-48 months doesn’t appear to pay attention to parents while they are speaking to him/her, this could be an early warning sign of autism and warrants a follow up with a qualified professional. - Autism can be accurately diagnosed in a subset of children using new eye tracking technology in just a few minutes. This finding helps us to re-think how autism is diagnosed, and opens up unprecedented opportunity to access diagnoses in remote areas where there are no clinicians available and to fast track participation in autism-relevant treatment.  MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: Future research should push the boundaries of what eye tracking technology can do to help children with autism and families. For example, scientists could possibly test whether or not treatment recommendations based on a child’s eye gaze profile accelerates gains in treatment faster than standard of care treatment. Disclosures: All of the research reported in the study was funded by the National Institute of Mental Health. Dr. Pierce has a patent pending through the University of California, San Diego that incorporates the eye tracking tests. Dr. Pierce received a donation from the ACES Innovation Fund to examine new ways to leverage eye tracking technology that could benefit children and families. Citations: - Maenner MJ, Shaw KA, Bakian AV, et al. Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2018. MMWR Surveill Summ. Dec 3 2021;70(11):1-16. doi:10.15585/mmwr.ss7011a1 - Courchesne E, Gazestani VH, Lewis NE. Prenatal Origins of ASD: The When, What, and How of ASD Development. Trends in neurosciences. 2020;43(5):326-342. doi:10.1016/j.tins.2020.03.005 - Pierce K, Gazestani VH, Bacon E, et al. Evaluation of the Diagnostic Stability of the Early Autism Spectrum Disorder Phenotype in the General Population Starting at 12 Months. JAMA Pediatr. Jun 1 2019;173(6):578-587. doi:10.1001/jamapediatrics.2019.0624 - Pierce K, Wen TH, Zahiri J, et al. Level of Attention to Motherese Speech as an Early Marker of Autism Spectrum Disorder. JAMA Netw Open. 2023;6(2):e2255125. doi:10.1001/jamanetworkopen.2022.55125 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Study Finds Multiple Shared Genes Between Gastrointestinal and Psychiatric Disorders

MedicalResearch.com Interview with:

Dr. Zhongshang Yuan Yuan, Zhongshang PhD Department of Biostatistics School of Public Health Shandong University Jinan, Shandong, China What is the background for this study? Response: Comorbidities and genetic correlations between gastrointestinal tract diseases and psychiatric disorders have been widely reported, with the gut-brain axis (GBA) hypothesized as a potential biological basis. However, it is unclear the degree to which the shared genetic determinants contribute to these associations underlying GBA. What are the main findings? Response: This study focused on 4 gastrointestinal tract disease (inflammatory bowel disease, irritable bowel syndrome, peptic ulcer disease, and gastro-oesophageal reflux disease) and 6 psychiatric disorders (schizophrenia, bipolar disorder, major depressive disorder, attention deficit hyperactivity disorder, posttraumatic stress disorder, and anorexia nervosa), resulting in 24 trait pairs, to explore the underlying shared genetic determinants. We found extensive genetic correlations and genetic overlaps among 22 out of 24 trait pairs. A total of 2,910 significant potential pleiotropic SNPs were identified in 19 trait pairs, with 83 pleiotropic loci and 24 colocalized loci detected. A total of 158 unique candidate pleiotropic genes were identified, which were highly enriched in certain GBA-related phenotypes and tissues, pathway enrichment analysis further highlighted biological pathways primarily involving cell adhesion, synaptic structure and function, and immune cell differentiation. Several identified pleiotropic loci also shared causal variants with gut microbiomes. Mendelian randomization analysis further illustrated vertical pleiotropy across 8 pairwise traits. Notably, many pleiotropic loci were identified for multiple pairwise traits, such as 1q32.1 (INAVA), 19q13.33 (FUT2), 11q23.2 (NCAM1), and 1p32.3 (LRP8). What should readers take away from your report? Response: The cutting-edge genome-wide pleiotropic analysis pipeline under the conceptual framework of GBA is highlighted. The pleiotropic variants and loci, genes as well as pathways shared between gastrointestinal tract diseases and psychiatric disorders were reported. What recommendations do you have for future research as a result of this study? Response: The results are mainly obtained from the genome-wide pleiotropic association analysis, , further experimental study is warranted to validate these findings. Is there anything else you would like to add? Any disclosures? Response: I have no conflicts of interest or other disclosures to report. Citation: Gong W, Guo P, Li Y, et al. Role of the Gut-Brain Axis in the Shared Genetic Etiology Between Gastrointestinal Tract Diseases and Psychiatric Disorders: A Genome-Wide Pleiotropic Analysis. JAMA Psychiatry. Published online February 08, 2023. doi:10.1001/jamapsychiatry.2022.4974 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Geisinger Study: Methadone ‘take-homes’ during COVID-19 Resulted in Greater Methadone Overdoses

MedicalResearch.com Interview with:

Dr. Piper Brian Piper, PhD MS Assistant Professor of Neuroscience Center for Pharmacy Innovation & Outcomes Geisinger School of Graduate Education MedicalResearch.com: What is the background for this study? Response: Methadone is an evidence-based treatment of opioid use disorder (OUD) and pain. However, this Schedule II opioid can also cause respiratory depression, which can result in lethality. The need for supervised administration is a long-standing source of frustration in the U.S. for many opioid use disorder (OUD) methadone patients. However, there was an accommodation in early 2020 thanks to the COVID-19 pandemic. This involved extending the take-home supply to up to 28-days for stable patients and 14 days for less stable patients. Prior research found that the implementation of supervised administration in England greatly reduced methadone overdoses . The primary objective of this study from Geisinger Commonwealth School of Medicine was to determine if the relaxation of the take-home rules resulted in more methadone overdoses.

MedicalResearch.com: What are the main findings? Response: Overdoses involving methadone from 1999 to 2020 were analyzed using data from the CDC’s WONDER database (Figure, left panel). There was a 48% increase from 2019 to 2020. Overdoses in 2020 were also significantly elevated relative to 2000–2003 and 2018 but significantly lower than 2006–2008. Among the top ten states for overdoses in 2020 (Rhode Island, Washington DC, Delaware, Connecticut, New Mexico, West Virginia, New York, Maine, Illinois, and Massachusetts), nine were located in the eastern US. New England states were also well represented. The association between methadone overdoses and methadone distribution as reported by the Drug Enforcement Administration was also evaluated. The state level correlations between overall methadone use (r(49) = +0.75, p < .001), and opioid treatment program use (r(49) = +0.77, p < .001) with overdoses were positive, strong, and statistically significant (center panel). However, methadone use for pain treatment was not associated with methadone overdoses (r(49) = −0.08, right panel). MedicalResearch.com: What should readers take away from your report? Response: Accommodations for the COVID-19 pandemic were both well-intentioned and necessary. However, great caution should be made before making them permanent. There is value in supervised administration, particularly for OUD patients early in recovery, regular urine-analysis, and in-person counseling. We are concerned about turning our backs on past lessons in how to maximize the safety of methadone for OUD treatment . These findings also contribute to a larger evidence base that methadone can be safely used for pain including cancer pain. MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: Death determination is made by both medical examiners and coroners and is not a simple process . Further research on methadone involved overdoses should be completed by states with the resources to run the analytical chemistry including for other substances (e.g. xylazine) that may contribute to lethality. This study did not determine how many of the decedents were prescribed methadone versus how many purchased diverted methadone. As other reports indicate that there were 300K methadone patients and over 3,000 methadone overdoses in a single year (i.e. 1 overdose per 1,000 patients or 0.1% per year for a drug that many patients receive for multiple years), this topic should warrant further empirical attention. MedicalResearch.com: Is there anything else you would like to add? Response: Methadone, when combined with counseling, is an evidence-based treatment for opioid use disorder. Because methadone retains patients in treatment better than buprenorphine , it will continue to be an important component of biopsychosocial treatments for OUD. Citations - Strang J, et al. Impact of supervision of methadone consumption on deaths related to methadone overdose (1993-2008): Analyses using OD4 index in England and Scotland, BMJ 341 (2010) c4851. - Kaufman et al. Examination of methadone involved overdoses during the COVID-19 pandemic. Forensic Science International 2023; 344:11579. https://authors.elsevier.com/a/1gXPQ1MCG0a4Rc - Peppin et al. What your death certificate says about you may be wrong: A narrative review on CDC's efforts to quantify prescription opioid overdose deaths. Cureus 2021; 13(9):e18012. - Mattick et al. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2008; 2:CD002207, Read the full article

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Study Evaluates High vs Low Intensity Exercise for Knee Arthritis

MedicalResearch.com Interview with:

Tom Arild Torstensen Department of Neurobiology, Care Sciences and Society Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden and Holten Institute, Stockholm, Sweden MedicalResearch.com: What is the background for this study? Response: People suffering from pain due to knee osteoarthritis (OA) is a major and increasing problem. There there is today good scientific evidence for different forms of exercise therapy, but there is no agreement regarding what type of exercises and what dose of exercise therapy is best. Thus, we wanted to investigate if high dose medical exercise therapy is superior to low dose. MedicalResearch.com: What are the main findings? Response:  The main findings from this superiority study do not support our hypothesis that high-dose exercise is superior to low-dose exercise. The only differences favoring high-dose exercise were in the domain of knee function during sports and recreation at the end of treatment and 6 months after the intervention and in the QoL domain at 6 months. Notably, most variables numerically favored the high-dose group, albeit not in a statistically or clinically meaningful way. Adherence was nearly perfect in the low-dose exercise group but was lower in the high-dose exercise group. No adverse events were reported. MedicalResearch.com: What should readers take away from your report? Response: Our study was designed as a superior trial, meaning that even though we failed to show that high-dose treatment is better than low-dose treatment, our results do not imply that a low-dose exercise regimen is as beneficial as a high-dose regimen. Interestingly, it seems that high-dose treatment could be preferable to low-dose treatment in the long run for people who lead active lives. This should be the subject of future studies. In the discussion we refer to positive and negative expectations (placebo/nocebo) in relation to pain as a homeostatic feeling (1 and 2) and that those mechanisms might have overrided the physiological effects of the difference in exercise dose during the 12 week intervention period. These mechanisms are surely present in our study because all patients in both high-dose and low-dose were supervised during the treatment by experienced physiotherapists. The basis for medical exercise therapy is close supervision using graded exercise therapy as a form of cognitive behavioral therapy applying methods like exposure and acceptance. It might be that the feeling state of pain is the game changer and when a person is experiencing pain and seeking help from a health professional the most important factor for a decrease in symptoms are the positive experience of being helped by the physiotherapist. MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: I believe we have to update our understanding of pain as a homeostatic emotion (1 and 2). That anxiety and pain are similar entities and the importance of health professionals being present with the patient supporting - communicating - with the patient during the treatment phase is fundamental for achieving a positive outcome. I also think we need to take a step back and do more RCTs having a comparison group with a minimal type of treatment but still getting the attention from the therapist exploring how important positive expectations (placebo) and negative expectations (nocebo) really are. As human beings we are social animals depending on each other, seeking help when we are not able to solve the problem ourselves. Thus we should stop looking at placebo as something negative. Instead we should look at positive expectations (placebo) and negative expectations (nocebo) as thoughts and feelings that makes us human. All the time we are thinking this is good or that is bad. And finally, when I treat a patient and designing an exercise program I am the exercises. The exercises are an extension of me, my personality, my thoughts and feeling, that I through the exercise give to the patient to help the patient. Citations: 1) Tom Arild Torstensen, Håvard Østerås, Riccardo LoMartire, et al. High- Versus Low-Dose Exercise Therapy for Knee Osteoarthritis: A Randomized Controlled Multicenter Trial. Ann Intern Med. . doi:10.7326/M22-2348 2) Larkin H. Both High- and Low-Dose Exercise Therapy Help Knee Osteoarthritis. JAMA. Published online February 01, 2023. doi:10.1001/jama.2023.0746 https://jamanetwork.com/journals/jama/fullarticle/2801204 3)     Craig AD. A new view of pain as a homeostatic emotion. Trends Neurosci 2003;26:303–7. 4)     Ingvar M. Learning mechanisms in pain chronification - teachings from placebo research. Pain 2015;156:S18–S23 “The seminal article of Craig with the description of pain as a homoeostatic emotion  moved the field away from the concept of a “searching for pain center” in the brain to a systems-oriented understanding. The experience of pain was put in a behavioural perspective and the dynamics of the preprogrammed complex emotional reactions to acute pain were explained in terms of a dynamic regulatory system. Just as in all other expressions of emotion, the homoeostasis model for understanding pain provides both a basis for a prolongation of the feeling state but also, at the same time, an effective measure of social communication to alert others of, eg, danger. In addition, such a mechanism also serves to raise empathic responses in the group. The understanding of pain as a homoeostatic emotion has also contributed to the understanding of affective comorbidity in different pain syndromes because the mechanisms of both lowered mood and anxiety are based on similar regulatory mechanisms. However, the mentioned mechanisms are mostly represented in the phylogenetically old components of the central nervous system. The role of the cerebral cortical regulation in chronic pain remains a challenge to fully explain”, Ingvar M (2015) pp:S18, line 13-31 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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New Kidney Function Equation Works Independent of Sex and Race

MedicalResearch.com Interview with:

Prof. dr. Pottel Prof. dr. Hans Pottel KU Leuven Kulak Department of Public Health and Primary Care Belgium MedicalResearch.com: What is the background for this study? Response:  The glomerular filtration rate (GFR) is used to diagnose patients with chronic kidney disease and is also used to adjust the dose of drugs that are eliminated by the kidneys. An accurate estimation of GFR is considered of importance in the management of kidney health in patients. In 2021 we published a new serum creatinine based equation, called the European Kidney Function Consortium (EKFC) equation (Pottel H. et al, Development and Validation of a Modified Full Age Spectrum Creatinine-Based Equation to Estimate Glomerular Filtration Rate : A Cross-sectional Analysis of Pooled Data. Ann Intern Med (2021) 174: 183-191): EKFC-eGFR = 107.3 / a x With a = 0.322 if Biomarker/Q is less than 1, and a = 1.132 if Biomarker/Q is 1 or more. The equation can easily be interpreted: the leading coefficient equals the glomerular filtration rate (GFR) of 107.3 mL/min/1.73m², which is the average GFR in healthy children (aged > 2 years), adolescents and young adults. The average healthy GFR remains constant until the age of 40 years, and starts decreasing beyond that age. The GFR is inversely related to the ‘rescaled’ biomarker. The rescaling factor (Q) is the average biomarker value for healthy people of a specific population (e.g. children, adult men, adult women, white people, black people, …). Biomarker/Q equals ‘1’ for the average healthy person, corresponding with eGFR = 107.3 mL/min/1.73m² (up to 40 years of age). It should be noted that for serum creatinine, the Q-value depends on sex and race. Our hypothesis was that the above equation is valid for any renal biomarker, on the condition that the biomarker is appropriately scaled. We showed that the same equation was able to estimate GFR from 2 years to oldest ages. In the current study we tested and validated our hypothesis by applying the above formula for appropriately ‘rescaled’ cystatin C. MedicalResearch.com: What are the main findings? Is there a practical advantage to the Cystatin-C based equation over eGFR, especially since the sex and race of patients are known?  Response: The main finding is that the above equation indeed works very well for appropriately rescaled cystatin C, with a scaling factor Q independent of sex and race. Our cystatin C based EKFC-equation can thus be used in Black and White patients, men and women, and potentially in patients of mixed ethnicity, in transgender patients, etc. Moreover, the equation can easily be extended to children by defining the scaling factor Q (which will be done soon in future research). This will make the equation applicable for all ages, avoiding implausible jumps at the transition between pediatric nephrology care and adult nephrology care. MedicalResearch.com: Does this equation have a cost advantage/disadvantage? Response: Currently the cost for cystatin C is about 10 times the cost for serum creatinine. In many countries the cost for cystatin C is not reimbursed by the social security agency. We are convinced that the current study might be a game changer. MedicalResearch.com: Is there anything else you would like to add? Any disclosures? Response: There is a variety in the quality of assays used to measure creatinine and cystatin C. One important requirement of our study was that serum creatinine was obtained with assays that were calibrated directly to the gold standard Isotope Dilution Mass Spectrometry method. For cystatin C all assays were calibrated against the international certified IFCC standard. Therefore, the current equation is only valid for high quality measurements of the biomarkers. One other important remark is that we included data from Black people in Europe and Africa, but we did not have high quality measurements of the biomarkers for African Americans. Therefore, the performance of our new cystatin C based equation should still be demonstrated in African Americans. Citation: Cystatin C–Based Equation to Estimate GFR without the Inclusion of Race and Sex Hans Pottel, Ph.D., Jonas Björk, Ph.D., Andrew D. Rule, M.D., Natalie Ebert, M.D., M.P.H., Björn O. Eriksen, M.D., Ph.D., Laurence Dubourg, M.D., Ph.D., Emmanuelle Vidal-Petiot, M.D., Ph.D., Anders Grubb, M.D., Ph.D., Magnus Hansson, M.D., Ph.D., Edmund J. Lamb, Ph.D., Karin Littmann, M.D., Ph.D., Christophe Mariat, M.D., Ph.D., et al. N Engl J Med 2023; 388:333-343 DOI: 10.1056/NEJMoa2203769 January 26 2023 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website. Read the full article

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Tiny Food Tastings Linked to Shorter Duration of Breastfeeding

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Yale Study Finds Pharmaceutical Companies Focus Advertising On Expensive Brand-Name Drugs

MedicalResearch.com Interview with: Neeraj Patel Medical Student (MS-2), Yale School of Medicine New Haven, CT MedicalResearch.com: What is the background for this study? Response: Direct-to-consumer pharmaceutical advertising has been increasing in popularity for the past two decades or so, particularly via television. But it’s highly controversial. Only two high-income countries (the U.S. and New Zealand) widely permit this type of advertising for prescription drugs. Critics have pointed to a growing body of literature that suggests that direct-to-consumer advertising for prescription drugs can be misleading, lead to inappropriate prescribing, and inflate healthcare costs. Proponents have argued that it improves public health by promoting clinically beneficial prescribing. MedicalResearch.com: What are the main findings? Response:  Our study assessed the most-commonly marketed drugs in these television advertisements and we had two main findings: First, we found that less than one-third of drugs commonly marketed from 2015 to 2021 were rated as having high therapeutic value, defined as providing at least moderate improvement in clinical outcomes compared to existing therapies according to at least one of three independent health technology assessment agencies. Second, we found that drugs categorized as “low benefit” accounted for $15.9 billion of the $22.3 billion (71.3%) in television advertising spending associated with our 73-drug sample over 6 years. MedicalResearch.com: What should readers take away from your report? Response: Taken together with other research, our findings suggest that pharmaceutical companies focus their advertising campaigns on expensive, brand-name drugs that have little or no comparative benefit versus existing alternatives. In general, I think our findings raise questions about the public health value that these advertisements are offering to society, especially when considering the body of research on the misleading nature and negative downstream effects of such advertisements on prescribing patterns and healthcare costs. From a public health standpoint, it’s concerning to me that the healthcare system allocates billions of dollars annually towards drug advertisements, as opposed to higher-quality forms of medical communication. In general, I hope that our research findings will encourage and help enable policymakers to create more rigorous, evidence-based regulations on prescription drug advertising. MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: Policymakers and regulators should consider requiring disclaimers on direct-to-consumer pharmaceutical advertisements regarding the comparative effectiveness of the products in such advertisements. Another concern about prescription drug advertisements is that they tend to have very low informational quality (as shown in a number of recent studies like this one). I think we should have more rigorous standards for weeding out misleading advertising and fund the FDA to apply current standards more proactively. Finally, given recent research on the harms and limited benefit of direct-to-consumer advertising of prescription drugs, I think policymakers should reconsider in which circumstances, if any, this type of advertising should be permitted. I have no conflicts of interest or other disclosures to report. Citation: Patel NG, Hwang TJ, Woloshin S, Kesselheim AS. Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021. JAMA Netw Open. 2023;6(1):e2250991. doi:10.1001/jamanetworkopen.2022.50991 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Specific Probiotic Dramatically Decreases Staph Aureus in the Gut

MedicalResearch.com Interview with: Michael Otto PhD Senior Investigator Laboratory of Bacteriology Chief of the Pathogen Molecular Genetics Section NIAID, NIH Bethesda, MD 20814 MedicalResearch.com: What is the background for this study? Response:  Staphylococcus aureus is one the of the most important causes of infectious diseases worldwide. It is known mostly for causing skin infections in the community and as a hospital-associated pathogen. It is in fact the most frequent cause of infections patients acquire in the hospital when they are weakened by underlying diseases or immune-suppressing therapy. The type of infections Staph can cause in these situations are diverse – comprising bone, lung, and blood infections (sepsis) - and can be quite severe and often fatal. Except for moderately severe skin infections that may not require antibiotic treatment, treatment of Staph infections is by antibiotics. S. aureus has naturally been very responsive to penicillin-type antibiotics, but already in the mid of the last century, resistance to penicillin spread worldwide. Then, methicillin was invented to overcome this resistance, but nowadays there also is considerable spread of methicillin-resistant strains (MRSA). The current situation is difficult for two reasons: - First, S. aureus has become increasingly resistant to many antibiotics, and - Second, the alternatives to methicillin are often by far not as efficient as penicillin/methicillin against Staph. Researchers have therefore been searching for alternatives to antibiotics to treat Staph infections. Unfortunately, vaccines that work against Staph have not yet been produced despite intensive efforts for decades. Other modern approaches of treatment, like virulence-targeted drugs or phages are still only at the early investigational level. As with many diseases, an alternative to treatment is prevention. In the case of S. aureus, a type of preventative strategy that has often been proposed and tested is decolonization. This is based on the fact that ~ 1/3 of the population is naturally colonized with S. aureus (asymptomatically), and these colonized people have an increased risk of being infected. In other words, Staph infections stem from the Staph you carry on your body and which only under certain conditions causes infection. Thus, eliminating the colonizing Staph would reduce the risk for infection, which is the basis for Staph decolonization-based infection prevention strategies. MedicalResearch.com: Which type of probiotic was utilized in this study? Response: By definition, probiotics are supplements containing live microorganisms. While they have gained much attention and are heavily marketed, the scientific basis or mechanism of their alleged benefit is not that clear. Furthermore, when you buy a “probiotic”, it is often an ill-defined mixture of many bacterial strains. Our approach is categorically different. The probiotic strain we use, Bacillus subtilis, is very specific and the mechanism by which it works for our purpose, is also very specific and described by us in a paper in Nature published in 2018. So, we know exactly what is going on. Namely, Bacillus produces specific lipopeptides that inhibit the quorum-sensing system of S. aureus, which in turn we also showed is essential for S. aureus gut colonization. The beauty of this approach is that we can specifically target the “bad” S. aureus while leaving the composition of the microbiome intact (the “good” bacteria we need for efficient digestion and as recent research has shown, many other things). This is because the targeted system is virtually only found in Staph. Notably, this specificity is much higher than that of other so-called “microbiome editing” approaches that are often based on bacteriocins, which despite some specificity still eliminate quite large groups of bacteria. It is the most specific “microbiome editing” approach that I am aware of. I should emphasize, because this is often misunderstood, that this approach does not kill S. aureus – but it strongly diminishes its capacity to colonize the intestine. MedicalResearch.com: What are the main findings? Response:  While I had to explain a lot about the scientific background – and we are proud we have such a detailed scientific basis, the trial is very straightforward. We simply wanted to test whether we can use this mechanism to decrease S. aureus colonization in humans in a way we had shown previously in the lab in mice. We gave healthy human volunteers Bacillus probiotic once daily for four weeks, and placebo to a control group, and checked after 4 weeks if there was an impact on S. aureus numbers in the intestine (as counted by analyzing feces). The effect was very strong: We could reduce S. aureus numbers by ~ 97%. With the intestinal site accounting for the vast majority of S. aureus numbers in the body, this approach thus eliminates > 95% of S. aureus in the body, while a nose-targeted approach can only eliminate a very small portion of S. aureus in the body. Likely, a decolonized nose is prone to be fast re-colonized from S. aureus in the gut. While a bit gross to describe how that works in detail, let’s just say we touch ourselves constantly everywhere without all the time using hand sanitizer. MedicalResearch.com: What should readers take away from your report? Response: First, there is of course the implication that this is a fantastic way to eliminate most of S. aureus colonization without doing any “harm” to the microbiome. In fact, B. subtilis probiotic even has other described beneficial effects. Then, our data also have scientific value for our understanding of the role of S. aureus gut colonization. This is because we don’t have any data on whether the gut plays that dominant role that we assume – and which is in stark contrast to current thinking by many S. aureus researchers. Before, it was simply not possible to specifically eradicate S. aureus in the gut to see what happens to colonization of the nose. In the trial, we also measured nasal S. aureus after intervention and found that there was a significant reduction of nasal S. aureus numbers. This, we believe, is a strong indication of a dominant role of gut colonization for overall S. aureus colonization. For the S. aureus field, this I believe should prompt a categorical rethinking of our notion of S. aureus colonization and thus also decolonization efforts.  MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: Looking forward, the next logical step would be to perform trials to see whether this approach can be used to reduce infection rates. We are currently trying to identify a patient cohort where our approach is deemed to be best applicable. The nature of our decolonization approach is long-term. In contrast to antibiotics, it may not work as fast, but it can be extended as it doesn’t cause harm. Thus, this will not work for a patient coming into a hospital who is undergoing surgery the next day. Patients that we are thinking of who could benefit from this approach include those with increased S. aureus infection risk in long-term care facilities or chronic and recurring S. aureus infections. My current view of S. aureus colonization dynamics is that the intestinal colonization forms a big reservoir, while nasal colonization is secondary and needs occasional “re-inoculation” from the gut. However, the nose may be more important than the gut as a direct source for infection: via the respiratory tract or nose picking for wounds. That means for decolonization measures that a combination of (1) our probiotic to reduce overall and intestinal colonization long-term with (2) additional antibiotic/antiseptic-based eradication in the nose and on the skin is probably the best way to achieve a fast-acting but also more persistent prevention of infection. Disclosures: There are no disclosures. This study was entirely financed by grants of our Thai collaborators in addition to the intramural program of the NIAID. Citation: Pipat Piewngam, Sunisa Khongthong, Natthrit Roekngam, Yongyuth Theapparat, Somkiat Sunpaweravong, Damrongsak Faroongsarng, Michael Otto. Probiotic for pathogen-specific Staphylococcus aureus decolonisation in Thailand: a phase 2, double-blind, randomised, placebo-controlled trial. The Lancet Microbe, 2023; DOI: 10.1016/S2666-5247(22)00322-6 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article

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Specific Probiotic Dramatically Decreases Staph Aureus in the Gut

MedicalResearch.com Interview with: Michael Otto PhD Senior Investigator Laboratory of Bacteriology Chief of the Pathogen Molecular Genetics Section NIAID, NIH Bethesda, MD 20814 MedicalResearch.com: What is the background for this study? Response:  Staphylococcus aureus is one the of the most important causes of infectious diseases worldwide. It is known mostly for causing skin infections in the community and as a hospital-associated pathogen. It is in fact the most frequent cause of infections patients acquire in the hospital when they are weakened by underlying diseases or immune-suppressing therapy. The type of infections Staph can cause in these situations are diverse – comprising bone, lung, and blood infections (sepsis) - and can be quite severe and often fatal. Except for moderately severe skin infections that may not require antibiotic treatment, treatment of Staph infections is by antibiotics. S. aureus has naturally been very responsive to penicillin-type antibiotics, but already in the mid of the last century, resistance to penicillin spread worldwide. Then, methicillin was invented to overcome this resistance, but nowadays there also is considerable spread of methicillin-resistant strains (MRSA). The current situation is difficult for two reasons: - First, S. aureus has become increasingly resistant to many antibiotics, and - Second, the alternatives to methicillin are often by far not as efficient as penicillin/methicillin against Staph. Researchers have therefore been searching for alternatives to antibiotics to treat Staph infections. Unfortunately, vaccines that work against Staph have not yet been produced despite intensive efforts for decades. Other modern approaches of treatment, like virulence-targeted drugs or phages are still only at the early investigational level. As with many diseases, an alternative to treatment is prevention. In the case of S. aureus, a type of preventative strategy that has often been proposed and tested is decolonization. This is based on the fact that ~ 1/3 of the population is naturally colonized with S. aureus (asymptomatically), and these colonized people have an increased risk of being infected. In other words, Staph infections stem from the Staph you carry on your body and which only under certain conditions causes infection. Thus, eliminating the colonizing Staph would reduce the risk for infection, which is the basis for Staph decolonization-based infection prevention strategies. MedicalResearch.com: Which type of probiotic was utilized in this study? Response: By definition, probiotics are supplements containing live microorganisms. While they have gained much attention and are heavily marketed, the scientific basis or mechanism of their alleged benefit is not that clear. Furthermore, when you buy a “probiotic”, it is often an ill-defined mixture of many bacterial strains. Our approach is categorically different. The probiotic strain we use, Bacillus subtilis, is very specific and the mechanism by which it works for our purpose, is also very specific and described by us in a paper in Nature published in 2018. So, we know exactly what is going on. Namely, Bacillus produces specific lipopeptides that inhibit the quorum-sensing system of S. aureus, which in turn we also showed is essential for S. aureus gut colonization. The beauty of this approach is that we can specifically target the “bad” S. aureus while leaving the composition of the microbiome intact (the “good” bacteria we need for efficient digestion and as recent research has shown, many other things). This is because the targeted system is virtually only found in Staph. Notably, this specificity is much higher than that of other so-called “microbiome editing” approaches that are often based on bacteriocins, which despite some specificity still eliminate quite large groups of bacteria. It is the most specific “microbiome editing” approach that I am aware of. I should emphasize, because this is often misunderstood, that this approach does not kill S. aureus – but it strongly diminishes its capacity to colonize the intestine. MedicalResearch.com: What are the main findings? Response:  While I had to explain a lot about the scientific background – and we are proud we have such a detailed scientific basis, the trial is very straightforward. We simply wanted to test whether we can use this mechanism to decrease S. aureus colonization in humans in a way we had shown previously in the lab in mice. We gave healthy human volunteers Bacillus probiotic once daily for four weeks, and placebo to a control group, and checked after 4 weeks if there was an impact on S. aureus numbers in the intestine (as counted by analyzing feces). The effect was very strong: We could reduce S. aureus numbers by ~ 97%. With the intestinal site accounting for the vast majority of S. aureus numbers in the body, this approach thus eliminates > 95% of S. aureus in the body, while a nose-targeted approach can only eliminate a very small portion of S. aureus in the body. Likely, a decolonized nose is prone to be fast re-colonized from S. aureus in the gut. While a bit gross to describe how that works in detail, let’s just say we touch ourselves constantly everywhere without all the time using hand sanitizer. MedicalResearch.com: What should readers take away from your report? Response: First, there is of course the implication that this is a fantastic way to eliminate most of S. aureus colonization without doing any “harm” to the microbiome. In fact, B. subtilis probiotic even has other described beneficial effects. Then, our data also have scientific value for our understanding of the role of S. aureus gut colonization. This is because we don’t have any data on whether the gut plays that dominant role that we assume – and which is in stark contrast to current thinking by many S. aureus researchers. Before, it was simply not possible to specifically eradicate S. aureus in the gut to see what happens to colonization of the nose. In the trial, we also measured nasal S. aureus after intervention and found that there was a significant reduction of nasal S. aureus numbers. This, we believe, is a strong indication of a dominant role of gut colonization for overall S. aureus colonization. For the S. aureus field, this I believe should prompt a categorical rethinking of our notion of S. aureus colonization and thus also decolonization efforts.  MedicalResearch.com: What recommendations do you have for future research as a results of this study? Response: Looking forward, the next logical step would be to perform trials to see whether this approach can be used to reduce infection rates. We are currently trying to identify a patient cohort where our approach is deemed to be best applicable. The nature of our decolonization approach is long-term. In contrast to antibiotics, it may not work as fast, but it can be extended as it doesn’t cause harm. Thus, this will not work for a patient coming into a hospital who is undergoing surgery the next day. Patients that we are thinking of who could benefit from this approach include those with increased S. aureus infection risk in long-term care facilities or chronic and recurring S. aureus infections. My current view of S. aureus colonization dynamics is that the intestinal colonization forms a big reservoir, while nasal colonization is secondary and needs occasional “re-inoculation” from the gut. However, the nose may be more important than the gut as a direct source for infection: via the respiratory tract or nose picking for wounds. That means for decolonization measures that a combination of (1) our probiotic to reduce overall and intestinal colonization long-term with (2) additional antibiotic/antiseptic-based eradication in the nose and on the skin is probably the best way to achieve a fast-acting but also more persistent prevention of infection. Disclosures: There are no disclosures. This study was entirely financed by grants of our Thai collaborators in addition to the intramural program of the NIAID. Citation: Pipat Piewngam, Sunisa Khongthong, Natthrit Roekngam, Yongyuth Theapparat, Somkiat Sunpaweravong, Damrongsak Faroongsarng, Michael Otto. Probiotic for pathogen-specific Staphylococcus aureus decolonisation in Thailand: a phase 2, double-blind, randomised, placebo-controlled trial. The Lancet Microbe, 2023; DOI: 10.1016/S2666-5247(22)00322-6 The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.     Read the full article