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Hansen, Bert. "American Physicians' Earliest Writings about Homosexuals, 1880-1900." Milbank Quarterly 67 (1989): 92. http://dx.doi.org/10.2307/3350187.
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Naramore, Sarah E. "Making Endemic Goiter an American Disease, 1800-1820." Journal of the History of Medicine and Allied Sciences 76, no. 3 (2021): 239–63. http://dx.doi.org/10.1093/jhmas/jrab018.
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Abstract In 1800, American physician and naturalist Benjamin Smith Barton (1766-1815) published A Memoir Concerning the Disease of Goitre as it Prevails in Different Parts of North-America. The text documented the nature of the disease in the United States and highlighted how it differed from the ailment’s presentation in European patients. While medical topographies were common during this period, Barton’s goiter research and the steady stream of American goiter research that followed are worth special attention. This body of literature demonstrates how American physicians understood their relationship to transnational medical discussions and the unique perspective they brought to them. Goiter literature was common in European medical and travel writing during this period and intensely focused on the appearance of the disease in the mountains of Switzerland and Northern Italy. American goiter by its very appearance in non-mountainous regions of the United States contradicted nearly all of the received wisdom about the ailment’s cause and potential cure. For two decades, American writers leveraged their own observations and local knowledge to challenge larger narratives in their field.
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Malakoff, Marion. "Palliative Care/Physician-Assisted Dying: Alternative or Continuing Care?" Care Management Journals 7, no. 1 (2006): 41–44. http://dx.doi.org/10.1891/cmaj.7.1.41.
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End-of-life care for dying patients has become an issue of importance to physicians as well as patients. The debate centers around whether the option of physician-assisted suicide cuts off, or diminishes the value of, palliative care. This ongoing attention makes the crafting of advance directives from patients detailing their end-of-life choices essential. Equally important is the appointment of a health care surrogate. The surrogate, when the patient is too ill to make decisions, should be empowered to make them in his stead. No American court has found a clinician liable for wrongful death for granting a request to refuse life support. An entirely separate issue is that of legalized physician-assisted suicide. As of this writing, only Oregon has made this legal (see Gonzales v. Oregon). It is likely that this issue will be pursued slowly through the state courts, making advance directives and surrogacy all the more crucial.
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Graham, S. Scott. "The Opioid Epidemic and the Pursuit of Moral Medicine: A Computational-Rhetorical Analysis." Written Communication 38, no. 1 (2020): 3–30. http://dx.doi.org/10.1177/0741088320944918.
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This article offers a longitudinal computational-rhetorical analysis of biomedical writing on opioids. Using a corpus of 1,467 articles and essays published in the New England Journal of Medicine and the Journal of the American Medical Association between 1959 and May 2019, this study evaluates diachronic shifts in (a) the framing of opioid pharmacology, (b) the relative attention paid to pain management versus opioid dependence risks, and (c) the distribution of statements related to physicians’ primary ethical obligations. The results of these analyses largely disconfirm different current accounts of shifting physician rhetoric around opioids and pain management leading up to the recognition opioid epidemic. Most notably, the results also suggest that biomedical debates surrounding opioids are serving as proxy arguments for shifting primary bioethical obligations from individual patients to public health.
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Wickliff, Gregory A. "Draper, Darwin, and the Oxford evolution debate of 1860." Earth Sciences History 34, no. 1 (2015): 124–51. http://dx.doi.org/10.17704/1944-6187-34.1.124.
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Historians of science have written much about the famous exchange over Darwinism in 1860 at the Oxford meeting of the British Association for the Advancement of Science between Bishop Samuel Wilberforce and Thomas Henry Huxley. The event is one of the most famous in nineteenth-century science. But little has been written about the paper that served as the occasion of that debate. The paper was one presented by John William Draper, a British-born American scientist and physician. A full transcription of Draper's paper is presented here, with a discussion of Draper's earlier writing and lectures on geology, evolution, and the philosophy of history. Together Draper's writings show his early adoption of key principles of the development hypothesis, his willingness to accept the principle of human evolution, and his claims for what he saw as the evolutionary nature of human society.
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Dorr, Gregory Michael. "Defective or Disabled?: Race, Medicine, and Eugenics in Progressive Era Virginia and Alabama." Journal of the Gilded Age and Progressive Era 5, no. 4 (2006): 359–92. http://dx.doi.org/10.1017/s1537781400003224.
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Something was menacing the South during the Progressive Era. Southern physicians located the threat in the “germ plasm,” the genes, of the region's inhabitants. Writing in a now-infamous 1893 “open letter” published in the Virginia Medical Monthly, Hunter Holmes McGuire, a Richmond physician and president of the American Medical Association, asked for “some scientific explanation of the sexual perversion in the negro of the present day.” McGuire's correspondent, Chicago physician G. Frank Lydston, replied that African-American men raped white women because of “[h]ereditary influences descending from the uncivilized ancestors of our negroes.” Lydston's solution to this problem was not lynching, but surgical castration which “prevents the criminal from perpetuating his kind.” Eight years later in Alabama, Dr. John E. Purdon opined, “It is a proved fact of experience that the inveterate criminal tends to propagates a race of criminals, and that the undeveloped or degraded nerve-tissue will duplicate itself in the next generation.” Dr. Purdon then declared, “Emasculation is the simplest and most perfect plan that can be adopted to secure the perfection of the race.” Twenty-three years later, in 1924, Harry Hamilton Laughlin testified in support of a Virginia law providing for the eugenic sterilization of the “shiftless, ignorant, and worthless class of anti-social whites of the South,” who allegedly created social problems for “normal” people. The multiplication of these “defective delinquents,” Laughlin and Virginia officials claimed, could only be controlled by restricting their procreation.
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Howanitz, Peter J., and George S. Cembrowski. "Postanalytical Quality Improvement." Archives of Pathology & Laboratory Medicine 124, no. 4 (2000): 504–10. http://dx.doi.org/10.5858/2000-124-0504-pqi.
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Abstract Objective.—To evaluate elevated patient calcium results as a postanalytic quality indicator of physician practices. Design.—Participants prospectively identified hypercalcemic patient results for 4 months or until they found 320 hypercalcemic results, and then, after at least 3 days, reviewed the medical records of these patients. Hypercalcemia was defined as a calcium value that exceeded the upper limit of each laboratory's reference range by 0.12 mmol/L or more. Participants, as well a subset of their physicians who did not acknowledge or respond to elevated results in the medical record, answered a questionnaire about their practices. Participants.—Five hundred twenty-five laboratories enrolled in the College of American Pathologists Q-Probes program. Main Outcome Measures.—The presence of hyercalcemic results in patients' medical records and physicians' acknowledgement and response to those elevated results. Results.—More than 5500 hypercalcemic results were identified, of which 53.2% represented a new finding. About 3.5% of results were not charted in the patients' records, and 23.1% of patient records did not contain clinician documentation of the abnormal result. Follow-up laboratory tests were not ordered for 13.8% of the elevated values. For 570 of the 808 results for which there was neither clinician documentation nor designated follow-up laboratory tests ordered, patients' physicians received written notification of the elevated calcium results along with a questionnaire. Responses were received from 386 physicians (68%). One hundred physicians indicated they did not order the specific calcium measurement, and of these 100, 85 responded it was part of a panel. The 286 physicians who ordered the test stated the results ultimately led to further testing (69%), a change of management (56%), or a new diagnosis (25%). Conclusions.—We found that a high percentage of abnormal results (3.5%) were not documented in the patients' medical records, the diagnosis of hypercalcemia frequently was new (53.2%), and a high percentage of physicians did not respond to elevated calcium results by writing a note (23.1%) or ordering another test (13.8%). Opportunities for quality improvement at these postanalytical steps are far greater than at the analytical step. Laboratorians must help physicians identify and respond to clinically important laboratory results.
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Brigham, Christopher, Lorne K. Direnfeld, Steven Feinberg, Les Kertay, and James B. Talmage. "Independent Medical Evaluation Best Practices." Guides Newsletter 22, no. 5 (2017): 3–18. http://dx.doi.org/10.1001/amaguidesnewsletters.2017.sepoct01.
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Abstract The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Sixth Edition, states that an independent medical evaluation (IME) usually is a “one-time evaluation performed by an independent medical examiner who is not treating the patient or claimant, to answer questions posed by the party requesting the IME.” Evaluators must adhere to best practice standards and must know that these standards may change over time and must meet the needs of the relevant jurisdiction. IMEs take place in several arenas, including automobile casualty, workers’ compensation, personal injury, medical malpractice, and long-term disability and differ from traditional clinical evaluations. The evaluating physician must be independent and has no (or only a limited) physician–patient relationship. The qualifications required of an IME examiner vary by arena, jurisdiction, and issues. Medical evaluators should be board certified and can obtain a special credential from, eg, the American Board of Independent Medical Examiners or the International Association of Independent Medical Evaluators. In addition, evaluators should have demonstrated abilities in report writing and court testimony, and a section of this article provides a general outline of the topics that should be covered in a thorough report. Quality IME reports are the result of thoughtful, thorough evaluations performed by physicians who have knowledge, skills, and experience in both clinical medicine and the assessment of medicolegal issues.
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Sabouni, Ammar, Abdelkader Chaar, Yamama Bdaiwi, et al. "An online academic writing and publishing skills course: Help Syrians find their voice." Avicenna Journal of Medicine 07, no. 03 (2017): 103–9. http://dx.doi.org/10.4103/ajm.ajm_204_16.
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Abstract Purpose: A group of Arab-American physicians and researchers in the United States organized a blended online course in academic writing and publishing in medicine targeting medical students and physicians in war-torn Syria. This was an effort to address one of the reasons behind the poor quantity and quality of scientific research papers in Syria and the Arab region. In this paper, we report on the design, conduct, and outcome of this course and attempt to evaluate its effectiveness. Methods: The educational intervention was a 2-month blended online course. We administered a questionnaire to assess satisfaction and self-reported improvement in knowledge, confidence, and skills of academic writing and publishing. Results: The course succeeded in reaching more than 2588 physicians and medical students from the region; 159 of them completed most of the course. Eighty-three percent of the participants felt that they were confident enough to write an academic paper after the course and 95% felt the learning objectives were achieved with an average student satisfaction of 8.4 out of 10. Conclusion: Physicians in Syria and neighboring countries are in need of training to become an active part of the global scientific community and to document and communicate the crisis their countries are going through from a medical perspective. Low-cost online educational initiatives help respond, at least partially, to those needs.
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Cedeño, Hugo Romeo Cedeño, and Telly Yarita Macías Zambrano. "Analysis of Latin American literature through a mathematical lens." International journal of social sciences 4, no. 1 (2021): 141–47. http://dx.doi.org/10.31295/ijss.v4n1.1524.
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Several of the most influential Latin American writers were interested in the sciences. Moreover, a handful showed an affinity to mathematics since childhood, eventually following careers as physicists, engineers, and mathematicians before turning their attention to the arts. In the end, they became novelists, essayists, and poets, who made significant contributions to their field. There is a large amount of existent traditional literature analysis research on Latin American authors. In the last sixteen years, research has shifted to include a focus on the connection between math and literature. However, this research focuses on interpreting the ideas of the universally acclaimed writer Jorge Luis Borges, studying his scientific thinking through his works, and demonstrating the writings included both basic and advanced math concepts even though he lacked a formal mathematical and scientific formation. Currently, there is a gap in the research that ignores the influential Latin American authors who were also prolific in mathematics. As a math and engineering student, I am interested in studying the work of Latin American writers with academic backgrounds in STEM fields--specifically mathematics. I intend to examine the writings of Ernesto Sabato, Guillermo Martinez, and Nicanor Parra for explicit math terminology and concepts.
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Pinsky, Tim. "GUEST EDITORIAL: In the Line of Fire: IME Burnout." Guides Newsletter 20, no. 3 (2015): 11–13. http://dx.doi.org/10.1001/amaguidesnewsletters.2015.mayjun03.
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Abstract Physicians suffer more burnout than many other American workers and rank near the top of all professions in burnout. Physicians who perform independent medical evaluations (IME) face the usual challenges (too many bureaucratic tasks, too many hours of work, insufficient income, and loss of status) that contribute to burnout among all physicians. Both “innate personality traits” and external factors (circumstances, examinees, time, performance, and risk) contribute to burnout among physicians who perform IME. Stressed because of multilayered litigation, insurance, and bureaucratic processes, IME physicians face a high concentration of difficult patients who are disgruntled with their jobs and, often, their lives. Examinees’ negative attitudes and outlooks contribute to pessimism and depression that can be contagious to the examiner, and because IMEs are one-time evaluations with no longitudinal care, the opportunity to establish rapport is limited. Physicians who are coping with the pressures of the IME milieu may need to realize that they have a greater sphere of positive influence than they realize: By conducting oneself in a professional and ethical fashion, writing fair reports, relying on evidence-based medicine, and applying the AMA Guides to the Evaluation of Permanent Impairment in a proficient manner, physicians who conduct IMEs can recognize and, one hopes, avoid IME burnout.
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Cutter, Martha J. "When Black Lives Really Do Matter: Subverting Medical Racism through African-Diasporic Healing Rituals in Toni Morrison’s Fiction." MELUS 46, no. 4 (2021): 208–34. http://dx.doi.org/10.1093/melus/mlac001.
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Abstract Toni Morrison spent much of her career detailing the unpredictability of African American existence within a racist society, with a special focus on patriarchal violence and medical apartheid against women’s bodies. Yet Morrison also limns out alternative modes of healing within a Black metacultural framework that moves between Nigeria, Brazil, and Egypt. As we move forward from the COVID-19 crisis, research has suggested that training more African American doctors, nurses, and physician assistants might curtail medical racism. Morrison’s fiction looks to a more basic level in which love of the bodies of African American people is at the center of healing. This article therefore discusses medical racism and applies Morrison’s lessons to the COVID-19 moment that her writing trenchantly foreshadows. It focuses on three healers who elide the medical establishment to embody a metacultural ethics of healing: Baby Suggs (in Beloved [1987]), Consolata Sosa (in Paradise [1997]), and Ethel Fordham (in Home [2012]). Morrison fuses an African-diasporic framework with embodied new knowledge that allows individuals to gain insight and agency in a white-dominant medical world that still refuses to endorse the idea that Black people’s bodies and psyches really do matter. An examination of these healers’ practices therefore sheds light on the COVID-19 moment by suggesting ways that African American people can stay “woke” and have agency when encountering and navigating traditional health care systems, which even today view the bodies of African Americans as fodder for medical experiments, immune to disease, and not in need of ethical and humane medical care.
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Chen, Jenny X., Stacey T. Gray, and David H. Jung. "Training Surgeon Scholars: Grant Writing Workshops During Residency." OTO Open 6, no. 2 (2022): 2473974X2211046. http://dx.doi.org/10.1177/2473974x221104663.
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Surgical residents may have limited experience with grant writing even though it is an important skill for academic physicians. We describe a novel curriculum on the conduct of research and grant literacy delivered at a single otolaryngology training program over 5 years. This workshop series included preparing a draft grant and conducting a mock grant review committee. In a survey of past participants (71% response rate), 91% found the workshops useful for grant writing or reviewing, and many used or planned to use the draft grants for real grant applications. The average number of American Academy of Otolaryngology–Head and Neck Surgery Foundation CORE grants submitted and successfully funded increased among residents at this program in the 4 years after the introduction of the workshop series as compared with the 4 years before. Further improvements continue to be made to the curriculum based on resident feedback.
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BRENT, ROBERT L. "Improving the Quality of Expert Witness Testimony." Pediatrics 82, no. 3 (1988): 511–13. http://dx.doi.org/10.1542/peds.82.3.511.
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Although various groups in our society have bemoaned the increasing frequency of negligence litigation and its concomitant costs, there has been an absence of any coordinated approach to solve this serious economic and social problem. Many physician groups, including our own American Academy of Pediatrics,1 have made attempts at tort reform. In my own earlier writings I suggested numerous alterations in the present system of tort law that I believed would improve the overall fairness of the system and decrease the excessive number of nonmeritorius law suits, not only in the medicolegal arena but in the whole area of negligence litigation.2,3
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Yamazaki, J. N. "CHILDREN OF THE ATOMIC BOMB: AN AMERICAN PHYSICIAN'S MEMOIR OF NAGASAKI, HIROSHIMA, AND THE MARSHALL ISLANDS." Pediatrics 97, no. 4 (1996): 553. http://dx.doi.org/10.1542/peds.97.4.553.
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This book was written especially for all those concerned for the welfare of children, but it also serves as a compendium for pediatricians to the hazards of atomic radiation and other effects of the bomb. In a sense the text may be considered a continuation of the Academy's endeavor to communicate related information to its membership in which I have participated in the past. This effort began in 1957 when the Academy created a Committee of Radiation Hazard and Epidemiology of Malformations that subsequently became the Committee on Environmental Hazards. My assignments included updating the information on the ongoing studies of the children in Hiroshima, Nagasaki, and the Marshall Islands and related studies, which the Committee reported in Pediatrics. It has been my privilege to serve on the Committee especially with Drs Robert Aldrich, Lee Farr, Fred Silverman, and Paul Wehrle, most of whom successively chaired the Committee. They have encouraged the writing of the narrative and have reviewed the manuscript.
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Liang, Wenchi, Judy Wang, Mei-Yuh Chen, Shibao Feng, Bin Yi, and Jeanne S. Mandelblatt. "Cultural Views, Language Ability, and Mammography Use in Chinese American Women." Health Education & Behavior 36, no. 6 (2009): 1012–25. http://dx.doi.org/10.1177/1090198109331669.
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Mammography screening rates among Chinese American women have been reported to be low. This study examines whether and how culture views and language ability influence mammography adherence in this mostly immigrant population. Asymptomatic Chinese American women ( n = 466) aged 50 and older, recruited from the Washington, D.C. area, completed a telephone interview. Regular mammography was defined as having two mammograms at age-appropriate recommended intervals. Cultural views were assessed by 30 items, and language ability measured women’s ability in reading, writing, speaking, and listening to English. After controlling for risk perception, worry, physician recommendation, family encouragement, and access barriers, women holding a more Chinese/Eastern cultural view were significantly less likely to have had regular mammograms than those having a Western cultural view. English ability was positively associated with mammography adherence. The authors’ results imply that culturally sensitive and language-appropriate educational interventions are likely to improve mammography adherence in this population.
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Stewart, Kearsley A. "Transforming Undergraduate Global Health Education Through a Humanities-Focused Curriculum." Pedagogy in Health Promotion 6, no. 1 (2020): 9–13. http://dx.doi.org/10.1177/2373379919900534.
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Global health needs the humanities today as medicine needed the humanities in the 1970s. When new biomedical technologies threatened to undermine the physician in their primary role of healing the patient, the field of medical humanities emerged to rehumanize the doctor and revive physician empathy through humanities methods and content such as close reading of poetry and novels, reflective writing, and critiquing art. In contrast, many of today’s undergraduate global health students are plagued by a surfeit, rather than a lack, of empathy to “save the world.” As the medical humanities transformed medical education, can today’s humanities and arts, especially the new fields of health humanities and critical medical humanities, transform global health education and practice by igniting a “global health humanities”? This essay focuses on emerging pedagogical and curricular challenges in nonclinical, undergraduate global health training primarily in North America.
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Terry, Paul E. "The “Best of 2020 List” of Health Promotion Researchers." American Journal of Health Promotion 35, no. 3 (2021): 330–33. http://dx.doi.org/10.1177/0890117121992224.
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Each year, the editorial team of the American Journal of Health Promotion selects our “Best of the Year List” of health promotion studies from the prior year. This editorial features the Editor’s picks, the Editor in Chief’s favorites and other award categories for the research and writing published in 2020 in this journal. Our criteria for selection includes: whether the study addresses a topic of timely importance in health promotion, the research question is clearly stated and the methodologies used are well executed; whether the paper is often cited and downloaded; if the study findings offer a unique contribution to the literature; and if the paper is well-written and enjoyable to read. Awardees in 2020 offered new insights into confronting systemic racism, the impact of state health policies on eating behaviors, the role of leaders in influencing employee health practices and the role of physicians in influencing patient health practices. You will see how researchers are studying psychological and emotional resiliency in ever more specific populations.
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Fischer, D. S., S. Alfano, M. T. Knobf, C. Donovan, and N. Beaulieu. "Improving the cancer chemotherapy use process." Journal of Clinical Oncology 14, no. 12 (1996): 3148–55. http://dx.doi.org/10.1200/jco.1996.14.12.3148.
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PURPOSE Reports of the tragic consequences of erroneous cancer chemotherapy overdoses at a prominent cancer center and a university hospital prompted a review of our institution's practices and those of 123 other hospitals to ascertain for each the current in-house process to prevent chemotherapy errors. METHODS A multidisciplinary committee of oncologists, nurses, and pharmacists reviewed the chemotherapy use process and identified opportunities for improvement. A 1-page facsimile survey was answered by 150 of 215 members of the American Society of Clinical Oncology (ASCO) who received it. RESULTS We further restricted the writing of cytotoxic chemotherapy orders to physicians who were board-certified or -eligible in hematology or medical, pediatric, and gynecologic oncology and their approved fellows. Dispensation of drugs is limited to oncology-certified pharmacists, and administration to chemotherapy-certified nurses. Standard orders are used either on special oncology forms or designated order sets in the computer. Procedures to regulate the ordering of antineoplastic drugs for nonmalignant indications by nononcology specialists are outlined. A process to prevent chemotherapy errors is in place in 95% of hospitals. Dedicated medical oncology units are ubiquitous, and most cancer centers and university hospitals have dedicated gynecologic and pediatric oncology units. Chemotherapy orders are generally written by oncology fellows and countersigned by an attending oncologist in cancer centers and university hospitals, whereas private oncology attending physicians write them in most community hospitals. Drugs are administered by oncology-certified nurses in most institutions. CONCLUSIONS These recommendations should improve the safety and effective use of chemotherapy and reduce the error rate to as close to zero as human fallibility will allow.
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Beller, George A., Jonathan Alexander, Kenneth L. Baughman, Julius M. Gardin, Marian C. Limacher, and Douglas S. Moodie. "The ACC training outcomes survey of recently trained cardiology fellows11Commissioned by the Writing Committee of the Physician Workforce Advisory Committee of the American College of Cardiology." Journal of the American College of Cardiology 35, no. 3 (2000): 808–14. http://dx.doi.org/10.1016/s0735-1097(99)00631-2.
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Taylor, P. C., P. Sidiropoulos, C. Ancuta, et al. "POS0512 DIFFERENCES IN TREATMENT SATISFACTION, PATIENT PREFERENCES, AND TREATMENT PATTERNS BETWEEN EUROPEAN, SOUTH AMERICAN, AND JAPANESE PATIENTS WITH SUBOPTIMALLY CONTROLLED RHEUMATOID ARTHRITIS: A SUBGROUP ANALYSIS OF THE SENSE STUDY." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 489–90. http://dx.doi.org/10.1136/annrheumdis-2021-eular.842.
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Background:Despite the availability of advanced therapies, many patients with rheumatoid arthritis (RA) do not achieve their treatment goals. Understanding geographic influence on patient perspectives and physicians’ attitudes toward treatment adjustments may inform region-specific strategies to improve outcomes in RA.Objectives:To explore differences in treatment satisfaction, patient preferences, and treatment strategies between patients from Europe (EU), South America (SA), and Japan (JP) with suboptimal control of RA.Methods:This is a subgroup analysis of SENSE, a non-interventional cross-sectional study in adults with RA who had moderate/high disease activity as measured by Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28[ESR]) >3.2, despite disease-modifying antirheumatic drug (DMARD) treatment. Patient satisfaction and preferences, treatment adherence, patient-reported outcomes, and physicians’ plans for DMARD switch were assessed as previously described.1 Predictors of good treatment satisfaction and physician’s decision not to switch DMARDs were identified using multiple logistic regression analyses.Results:Of 1234, 272, and 118 patients enrolled from EU, SA, and JP, respectively, 13.9%, 15.4%, and 5.9% reported good treatment satisfaction. Irrespective of region, patients reported impaired quality of life and good treatment adherence, and around one-third of patients received targeted synthetic (ts) or biologic (b) DMARDs. Among patients treated with ts/bDMARDs, monotherapy was most common in SA (45.3%), followed by EU (26.3%) and JP (18.8%), consistent with a greater acceptance of combination therapy in JP. More than 80% of JP patients preferred oral treatments versus <60% of EU/SA patients. DMARD switches were planned in 51.8% (EU), 57.4% (SA), and 38.1% (JP) of patients, most commonly to a tumor necrosis factor inhibitor. Predictors for good treatment satisfaction included treatment with ts/bDMARDs and the presence of psychiatric disorders in EU and SA; however, current disease activity was not a common predictor (Table 1). Reluctance to switch treatments was predicted by lower disease activity assessed by DAS28(ESR) (all regions) and current treatment with ts/bDMARDs (EU/SA).Table 1.Predictors for good treatment satisfaction and no treatment switch plannedOR (95% CI)Europe(n=1234)South America(n=272)Japan(n=118)Good treatment satisfaction (TSQM global treatment satisfaction ≥80)Current treatment with ts/bDMARDs3.8 (2.7, 5.4)****4.9 (2.2, 10.8)****—Psychiatric disorders2.4 (1.3, 4.6)**3.1 (1.2, 8.4)*—Number of comorbidities——2.3 (1.2, 4.3)*Worst joint pain—1.3 (1.1, 1.5)**SF-36 MCS1.0 (1.0, 1.1)****—1.3 (1.1, 1.5)**SF-36 PCS1.1 (1.0, 1.1)****——Work Productivity and Activity Impairment–Rheumatoid Arthritis:Total activity impairment—1.0 (1.0, 1.0)***—DAS28(ESR) >5.1—0.3 (0.1, 0.7)**—Female——0.1 (0.0, 0.9)*No treatment switch plannedCurrent treatment with ts/bDMARDs3.9 (3.0, 5.2)****2.4 (1.4, 4.2)**—Number of comorbidities1.2 (1.1, 1.4)****——Age——1.0 (1.0, 1.1)*TSQM effectiveness subscore1.0 (1.0, 1.0)***1.0 (1.0, 1.0)***—Number of concomitant medications0.9 (0.8, 1.0)**——DAS28(ESR)0.5 (0.5, 0.6)****0.6 (0.5, 0.8)***0.6 (0.4, 0.9)*X2 test: ****p<0.0001, ***p<0.001, **p<0.01, *p<0.05CI, confidence interval; OR, odds ratio; SF-36 M/PCS, 36-Item Short-Form Survey mental/physical component summary; TSQM, Treatment Satisfaction Questionnaire for MedicationConclusion:In patients with moderate to high RA disease activity, current disease control was a common determinant of treatment switches. Predictors for good treatment satisfaction revealed region-specific patient attitudes to treatment acceptance despite poor disease control.References:[1]Taylor PC, et al. Ann Rheum Dis 2020;79:996–7Acknowledgements:AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and participated in the writing, review, and approval of this abstract. No honoraria or payments were made for authorship. Medical writing support was provided by Hilary Wong, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of Interests:Peter C. Taylor Speakers bureau: AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly, Fresenius, Galapagos, Gilead, GSK, Janssen, Nordic Pharma, Pfizer, Roche, Sanofi, and UCB., Consultant of: AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly, Fresenius, Galapagos, Gilead, GSK, Janssen, Nordic Pharma, Pfizer, Roche, Sanofi, and UCB., Grant/research support from: AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly, Fresenius, Galapagos, Gilead, GSK, Janssen, Nordic Pharma, Pfizer, Roche, Sanofi, and UCB., Prodromos Sidiropoulos Speakers bureau: AbbVie, Amgen, MSD, Novartis, Pfizer, Roche, and UCB., Consultant of: AbbVie, Amgen, MSD, Novartis, Pfizer, Roche, and UCB., Grant/research support from: AbbVie, Amgen, MSD, Novartis, Pfizer, Roche, and UCB., CODRINA ANCUTA Speakers bureau: AbbVie, Eli Lilly, Ewopharma, MSD, Novartis, Pfizer, Roche, and UCB., Consultant of: AbbVie, Eli Lilly, Ewopharma, MSD, Novartis, Pfizer, Roche, and UCB., Ivan Lagunes-Galindo Employee of: AbbVie employee and may own stocks or options, Maria DeLaVega: None declared, Umut Kalyoncu Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB., Consultant of: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB., Orsolya Nagy Employee of: AbbVie employee and may own stocks or options, Atsushi Kawakami Speakers bureau: AbbVie, Actelion, Asahi Kasei, Astellas, Boehringer Ingelheim, Celltrion, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, GSK, Janssen, Kowa, MedPeer, Mitsubishi Tanabe, Novartis, ONO, Pfizer, Taisho, and Takeda, Grant/research support from: AbbVie, Actelion, Asahi Kasei, Astellas, AYUMI, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Kyowa Hakko Kirin, MSD, Neopharma, Novartis, ONO, Sanofi, Taisho, Takeda Science Foundation, and Teijin.
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Price Herndl, Diane. "American Women of Letters and the Nineteenth-Century Sciences: Styles of Affiliation, and: Out of the Dead House: Nineteenth-Century Women Physicians and the Writing of Medicine, and: Bodily and Narrative Forms: The Influence of Medicine on American Literature, 1845-1915 (review)." Legacy 20, no. 1 (2003): 217–19. http://dx.doi.org/10.1353/leg.2003.0052.
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Parsons, Kelly, Justin Barber, Allison Gibson, Gregory Jicha, and Renee White. "STARTING THE CONVERSATION: FINDINGS FROM AN ADVANCE CARE DIRECTIVE WORKSHOP." Innovation in Aging 6, Supplement_1 (2022): 686–87. http://dx.doi.org/10.1093/geroni/igac059.2520.
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Abstract Every adult that enters a hospital is asked about an advance care directive (ACD) document. The completion rates of care directives started to grow in 2016, when Medicare provided a reimbursement benefit in the annual wellness exam. Previous data shows only 37% of older Americans have an ACD, of that 64% are white. Previous studies report data from medical visits, however, advance directive discussions conducted in a community setting has not yet been explored. This pilot study examines readiness to have discussions with your appointed decision-maker, primary care provider, and complete ACD document. This was a community workshop with a physician-led presentation regarding medical choices, followed by break-out groups with trained moderators reviewing ACD materials. Data from pre/posttest along with qualitative comments addressing information seeking (pre) and additional comments (post) are included. The workshop increased participants readiness to identify an individual to make medical decisions and put into writing the type of medical care they desire. It also showed resistance to having conversations with a person's primary care provider and chosen health care agent. Challenges included the pre/posttest completion rate and the inability to compare a control group. Viewing advance directive completion within the self-determination theory assists in understanding the need for a novel setting to promote relatedness. Further research needs to be done on community setting ACD workshops to provide a space for participants to be better informed in the ACD process. Community workshops need to be examined to have a broader spectrum of inclusion within historically marginalized communities.
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Lapeña, José Florencio F. "Supporting Scholarly Writing Skills and Standards: Promotion and Priority." Philippine Journal of Otolaryngology-Head and Neck Surgery 27, no. 2 (2012): 4–5. http://dx.doi.org/10.32412/pjohns.v27i2.515.
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“I’m deep inside a funny mood again,
 like to brood again, if I could again
 I feel like walking on a cloud again,
 think aloud again, write and then...”1
 
 The “Kuala Lumpur Declaration on Promotion of Scholarly Writing Skills and Standards in the Asia Pacific Region” was launched at the 2012 Convention of the Asia Pacific Association of Medical Journal Editors (APAME) held in Kuala Lumpur, Malaysia from 31 August to 3 September 2012.2 Considering the importance of “scholarly, scientific and technical health information” as an “invaluable resource” for “universal health promotion and policy development;” the necessity that this health information be “reliable, comprehensible and available” to the region and the world; the reality that the Asia Pacific region represents over half of the world population that both “generate(s) and need(s) an enormous amount of health information;” and that the Asia Pacific Association of Medical Journal Editors (APAME) “is an important catalyst for the promotion of scholarly writing skills and standards” that will “increase the reliability, comprehensibility and availability” of such vital health information; participants confirmed their commitment to “promoting scholarly writing skills and standards;” to the “continuing education of researchers, authors, reviewers and editors;” and to “collaboration with academic societies, universities, government and non-government organizations” in order to “ensure greater access to publication;” “empower them to write, review and edit;” and “promote research and publication” thereby “elevating loco-regional research and publishing to the global arena;” “promoting health and well-being in the region and the world;” and the “betterment of health and societal development in the region and globally.”2
 
 The promotion of scholarly writing skills and standards presupposes giving them preference, precedence or priority (1: the quality or state of being prior; 2: precedence 3: superiority in rank, position, or privilege; 4: a preferential rating; especially: one that allocates rights to goods and services usually in limited supply; 5: something given or meriting attention before competing alternatives).3 Without prioritization, promotion is mere lip service. Promotion (the act of furthering the growth or development of something; especially: the furtherance of the acceptance and sale of merchandise through advertising, publicity, or discounting)4 in publishing entails concrete and sustained measures to ensure the growth and development of individual and collective researchers, authors, reviewers and editors, as well as librarians and ultimately, our readers.
 
 The Introductory Medical Writing Skills Workshop co-hosted by the Philippine Society of Otolaryngology Head and Neck Surgery on November 17, 2012 embodies “our commitment to the continuing education of researchers, authors, reviewers and editors, to empower them to write, review and edit scholarly manuscripts for publication and dissemination, thereby promoting health and well-being in the region and the world.”2 This workshop begins the formal introduction of Fellows, Diplomates and Resident Physicians to “scholarly writing skills and standards, in order to set the example for our peers, authors, reviewers, editors and librarians.”2
 We are conducting or have conducted similar workshops in Manila, Davao, Cebu, Baguio and Iloilo as well as in Singapore, Malaysia, Brunei Darussalam, India, Vietnam and Cambodia. Ultimately, this workshop will help the Philippine Journal of Otolaryngology Head and Neck Surgery attain “increasing scholarly quality worthy of continued production and dissemination.”2
 
 I was especially gratified to recently learn from a colleague that a 2009 article published in our journal had generated an inquiry from a potential patient in Australia, who was in search of a therapeutic solution for his problem. It is this same visibility that generates submissions from various countries, which to date includes Malaysia, India, Brunei Darussalam, Japan, New Zealand, Turkey and the United States of America. As we continue to grow and nurture our international pool of authors, reviewers and editors, may we likewise harvest more and more local talent for the various roles that make up our journal.
 
 I am very happy to announce that the Philippine Journal of Otolaryngology Head and Neck Surgery is now also indexed on the Asia Pacific Medical Journal Articles Central Archives (APAMED Central) available at http://apamedcentral.org/ a digital archive and reference linking platform of journals published in Member States of the WHO Western Pacific Region and Southeast Asian Region, supported by the World Health Organization and powered by KoreaMed Synapse. This additional archive ensures our increasing presence to the rest of the world, promoting greater visibility of our published research.
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Ortiz, Cristian. "Changing time." Journal of the Foot & Ankle 14, no. 2 (2020): 115. http://dx.doi.org/10.30795/jfootankle.2020.v14.1188.
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Any forecast of the pandemic dynamics has proven to be far away from what has really happened, particularly in South America. In most of our countries, we are still struggling with what has been called the first wave. The virus has impacted not only our health status but also every aspect of our lives, including our daily work. Spending less time in the operating room has a positive side that each one has experienced differently. It has provided the opportunity for more quality time with the family and an understanding of how vulnerable we all are, how complicated politics and economic decisions are, and how important the way we all communicate and share experiences is.Most of us have seen our workplaces becoming busy with an increasing number of patients, which has led us to cancel any elective surgery and stay home in isolation. This difficult time we are going through has allowed us to think about our purpose in life, especially as physicians. We have been forced to develop new ways of teaching medicine, researching, and even practicing medicine. Most importantly, difficult times require that we learn a new way of living.This has led us to reflect on the importance of research and on how important it is that all of us give our best for our patients. Treating patients well impels us to be informed, to be updated about new knowledge, and to practice our skills while continuously looking for answers. The virtuous circle to be a good doctor should always include clinical practice, medical education, and research.When I was asked to write this editorial, one thought immediately came to my mind: how easily some journalists and public figures get into trouble after making a comment, writing an editorial, or even after publishing a post on social media. A recent example is what happened to J. K. Rowling, the famous author of the Harry Potter series. Last December, she tweeted her support for Maya Forstater, who was fired for what were deemed “transphobic” tweets. Rowling has received accusations and threats from trans activists and many worldwide famous people. A single ‘like’ was deemed evidence of ‘wrongthink’, and a persistent level of harassment began. The world has definitely changed, and everyone’s comments and behaviors are completely public. We should not be afraid to speak up and express our opinion, we should not be stopped by the fear of having people against us. As physicians, we are all exposed by expressing our medical opinion every day in the office, in a meeting, or even in a remote setting. Every decision and opinion should be based on evidence, but they will inevitably include our personal background-which is a mix of knowledge and personal life experience. Hopefully, these opinions will always express our genuine interest in the patients and their families as our main focus.As I get older, I pay more attention to the basis of my daily practice, which begins with proper information provided by good sources of medical education such as this journal. However, acquiring reliable information is just the beginning of the path toward good medical practice. The remainder of the path-the most important part of it-must be trodden by a human being truly interested in doing the best for his/ her patients every day.
 It has always amazed me that everyone who I admire as a physician is, at the same time, a professor, a researcher, and an amazing human being. This journal is the result of the efforts of a group of people who are truly committed to learning, teaching, and investigating, thus producing friendly feedback and updated knowledge.
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Amin, Alpesh, Jay Lin, and Amy Ryan. "VTE Prophylaxis Across the Continuum of Care in US Medical Patients at Risk of Venous Thromboembolism." Blood 114, no. 22 (2009): 1386. http://dx.doi.org/10.1182/blood.v114.22.1386.1386.
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Abstract Abstract 1386 Poster Board I-408 Background: Medical patients with chronic medical illnesses are often at risk of VTE both in-hospital and post-discharge. However, although injectable prophylaxis options are available and suitable for providing in-hospital and post-discharge prophylaxis, there is often a lack of continuity in VTE post-discharge prophylaxis. This analysis evaluated in-hospital and post-discharge VTE prophylaxis patterns for US medical patients. Methods: Premier's Perspective™ inpatient data were cross-matched at the individual patient level with Ingenix LabRx® outpatient data from the I3 database (January 2005-December 2007) to assess VTE prophylaxis patterns in medical patients (cancer without surgery, heart failure, severe lung disease, infectious disease) at risk of VTE (according to the American College of Chest Physicians 2004 guidelines) and with no contraindications for anticoagulation. Inpatients were assessed for any anticoagulation received in-hospital and were followed post-discharge to assess their outpatient prophylaxis use. Drug utilization and clinical practice patterns during and within 30 days after hospitalization were collected and compared descriptively between groups. Results: Of the 9,675 medical discharges at risk of VTE and included in this analysis, 6,185 (63.9%) did not receive any anticoagulation at all. Of the remaining 3,490 (36.1%) discharges that did receive anticoagulation, 2,045 (58.6%) received enoxaparin and 1,044 (29.9%) received unfractionated heparin (UFH) (Table). After discharge, 98.2% of all patients did not receive any prophylaxis within the following 30 days. Only 174 (1.8%) discharges received outpatient prophylaxis, with 67.8% receiving warfarin alone and 18.4% receiving enoxaparin and warfarin (Table). Conclusion: This analysis presents both inpatient and outpatient VTE prophylaxis patterns in real-world medical patients that are at risk of VTE. Nearly 64% of patients received no inpatient VTE prophylaxis, and less than 2% received outpatient prophylaxis. Further efforts to improve VTE prevention in hospitalized patients are required, with particular emphasis needed on the transition to outpatient prophylaxis. Disclosures: Amin: sanofi-aventis: Research Funding, Speakers Bureau, The authors received editorial/writing support in the preparation of this abstract funded by sanofi-aventis U.S., Inc.. Lin: sanofi-aventis: Employment. Ryan: sanofi-aventis: Research Funding.
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Levin, D. C., G. J. Becker, G. Dorros, et al. "Training standards for physicians performing peripheral angioplasty and other percutaneous peripheral vascular interventions. A statement for health professionals from the Special Writing Group of the Councils on Cardiovascular Radiology, Cardio-Thoracic and Vascular Surgery, and Clinical Cardiology, the American Heart Association." Circulation 86, no. 4 (1992): 1348–50. http://dx.doi.org/10.1161/01.cir.86.4.1348.
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Butler, Stephen. "A personal experience learning from two pain pioneers, J.J. Bonica and W. Fordyce: Lessons surviving four decades of pain practice." Scandinavian Journal of Pain 1, no. 1 (2010): 34–37. http://dx.doi.org/10.1016/j.sjpain.2009.09.009.
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AbstractThis article was requested by the Editor, Professor Harald Brevik after listening to a lecture I gave in a similar vein. Harald wanted the information in print and I have done this in a partly autobiographical form to explain how I came to work and learn from both the late John J. Bonica and the late Wilbert Fordyce.Both of these men have been important in different ways to our present pain world. John J. Bonica made many contributions not only in pain but in regional anesthesia and obstetrical anesthesia but not on the same level. His conviction and drive in the pain field actually revolutionized pain research and practice. Dr. Bonica early on knew he needed help with difficult cases and began a multidisciplianary clinic that served as a model for all. He wrote and published the first really comprehensive text on pain (The Management of Pain) that has appeared in two subsequent revisions and a third revision is in progress. He succeeded in founding the International Association for the Study of Pain to bring clinicians and researchers together so that we could learn from each other. Again, Dr. Bonica felt that the multidisciplinary approach to research was the key to unlocking the secrets of pain. Dr. Bonica also succeeded in persuading the American Congress and the WHO that pain was a significant problem not only for all Americans but for all humanity. His drive was an inspiration to all who came in contact with him and he touched my life in several ways as a teacher, a colleague and a patient.Bill Fordyce was not a larger than life individual like John J. Bonica but he also had a profound effect on the pain world and on me. Bill was one of the first real champions of the application of behavioural principles to the treatment of chronic pain. His visionary and inventive use of operant behavioural therapy in a multidisciplinary pain setting set the mark for all comprehensive pain clinics and the principles he used are still in effect world wide and are making converts of more and more practitioners frustrated by the lack of advances using the biomedical model. Bill created a whole new area of treatment that has made pain rehabilitation a thriving business and has made practical use of the biopsychosocial model of Engel as an explanation for much of the disability and suffering in chronic pain.For me, John J. Bonica was an inspiration for hard work and constant learning. Bill Fordyce taught me new tools to use to understand many complicated pain patients but also many practical aphorisms to guide evaluation and treatment. I have been extremely lucky in being able to have had a long relationship with both of these pain giants who were always open to discussion and debate over the difficult problems. Their teaching both by example, discussion and in their writing had and still has a strong effect on my life as a physician, a pain practitioner and a teacher. I would like to pass on some of that information to all interested in research, teaching and pain management. As they say in Sweden, “Var så god!”.
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Ongtengco, Ana, Kevin Roy, Liang Zhang, and Jessie Chin. "An Explorative Longitudinal Study on the Five-Year Patient Portal Use among an Underserved Patient Population." Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 8, no. 1 (2019): 146. http://dx.doi.org/10.1177/2327857919081035.
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The purpose of the study was to identify and assess multiple aspects of patient portal usage behavior in an underserved urban patient population. Given the rise of patient-centered care, patients are required to take active roles to gather health information, make informed health decisions and manage their own healthcare, which behavior were associated with health outcome (Barry & Edgman-Levitan, 2012; Oates, Weston & Jordan, 2000). Patient portals serve as a mean to coordinate patient-centered care by delivering health information to patients (e.g. medical test results), exchanging information with healthcare providers (e.g., messaging providers), and facilitating the delivery of health care services (e.g., scheduling appointments). However, studies often showed that patients in underserved communities did not take full advantages of the patient portals (e.g,. Cazaja et al., 2015, Wallace et al., 2016). These disparities in patient portal usages were associated with many factors, including the complexities of the American healthcare system, lack of internet access, lack of support to navigate through the health systems, and the lack of health literacy among an underserved adult population. To better understand the current use of patient portal of an underserved patient population, we conducted an explorative analysis of portal usage at the University of Illinois Hospitals and Health Sciences System (UIHealth). UIHealth serves throughout the city of Chicago, including areas with high racial segregation (minority population higher than 75%), where patients’ household income is lower than the median of Chicago residents. The majority of patient populations in UIHealth are African Americans (61%) followed by Hispanic/Latino (17%) and White (17%). The study was conducted using a retrospective analysis of Google Analytics portal data from March 2015 to March 2019. User behavior data were extracted to show aspects of usage, including most popular portal functions, language used, time spent on each page, and returning user visits, etc. We used weekly summary data as individual data points (208 data points in total) in the analysis. We found that, over four years, both retuning and new users increased by more than 50%. Regarding the number of users per week, there were local drops in the overall growth which drops were associated with fewer visits to UIHealth during holidays or cold weather. Hence, portal visits were associated with clinic visits. With regards to the most popular functions, writing messages to healthcare providers and viewing medical test results were the most used functions over the years. Results suggested that patients would utilize portal to gather information about their health status (for later discussion with physicians or making informed decisions) and communicate with healthcare providers. Interestingly, we found the dominant devices used to access the portal have shifted from desktop computers (2015-2017) to mobile phones (2017-2019), suggesting the increasing need to present health information in bitable size in smaller screens; and the increasing smartphone adoptions of underserved adults as an alternative solution to get internet access. Overall, improving the accessibility of patient portals remains to be a major issue for empowering patients in contemporary value-based healthcare systems. The explorative study has shed lights on the longitudinal trends of portal usage among an underserved population, which creates practical implications on the design of a more efficient interface between patients and their healthcare providers with the ultimate goal to improve health equity.
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Manchikanti, Laxmaiah. "An Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain. Part I: Introduction and General Considerations." Pain Physician 2s;16, no. 2s;4 (2013): S1—S48. http://dx.doi.org/10.36076/ppj.2013/16/s1.
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In 2011, the Institute of Medicine (IOM) re-engineered its definition of clinical guidelines as follows: “clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options.” This new definition departs from a 2-decade old definition from a 1990 IOM report that defined guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” The revised definition clearly distinguishes between the term “clinical practice guideline” and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria. The IOM committee acknowledged that for many clinical domains, high quality evidence was lacking or even nonexistent. Even though the guidelines are important decisionmaking tools, along with expert clinical judgment and patient preference, their value and impact remains variable due to numerous factors. Some of the many factors that impede the development of clinical practice guidelines include bias due to a variety of conflicts of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Consequently, a knowledgeable, multidisciplinary panel of experts must develop guidelines based on a systematic review of the existing evidence, as recently recommended by the IOM. Chronic pain is a complex and multifactorial phenomenon associated with significant economic, social, and health outcomes. Interventional pain management is an emerging specialty facing a disproportionate number of challenges compared to established medical specialties, including the inappropriate utilization of ineffective and unsafe techniques. In 2000, the American Society of Interventional Pain Physicians (ASIPP) created treatment guidelines to help practitioners. There have been 5 subsequent updates. These guidelines address the issues of systematic evaluation and ongoing care of chronic or persistent pain, and provide information about the scientific basis of recommended procedures. These guidelines are expected to increase patient compliance; dispel misconceptions among providers and patients, manage patient expectations reasonably; and form the basis of a therapeutic partnership between the patient, the provider, and payers. Key words: Evidence-based medicine (EBM), comparative effectiveness research (CER), clinical practice guidelines, systematic reviews, meta-analysis, interventional pain management, evidence synthesis, methodological quality assessment, clinical relevance, recommendations.
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Amin, Alpesh, Jay Lin, and Amy Ryan. "VTE Prophylaxis Across the Continuum of Care in US Orthopedic Surgery Patients." Blood 114, no. 22 (2009): 2097. http://dx.doi.org/10.1182/blood.v114.22.2097.2097.
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Abstract Abstract 2097 Poster Board II-74 Background: Patients who undergo major orthopedic surgery are at significant risk of developing VTE. As 40-60% of orthopedic surgery patients develop VTE in the absence of thromboprophylaxis, evidence-based guidelines recommend pharmacological VTE prophylaxis in all patients without contraindications. As the risk of VTE persists beyond discharge in these patients, the use of LMWH and warfarin post-discharge is both suitable and recommended. However, a lack of awareness and education often leads to an absence of VTE prophylaxis post-discharge. This analysis evaluated in-hospital and post-discharge VTE prophylaxis patterns for US orthopedic surgery patients. Methods: Premier's Perspective” inpatient data were cross-matched at the individual patient level with Ingenix LabRx® outpatient data from the I3 database (January 2005-December 2007) to assess VTE prophylaxis patterns in major orthopedic surgery (total knee arthroplasty, total hip arthroplasty, hip fracture surgery) patients at risk of VTE (according to the American College of Chest Physicians 2004 guidelines) and with no contraindications for anticoagulation. Inpatients were assessed for the anticoagulant received in-hospital and were followed post-discharge to assess their outpatient prophylaxis use. Drug utilization and clinical practice patterns during and within 30 days after hospitalization were collected and compared descriptively between groups. Results: Of the 3,311 orthopedic surgery discharges at risk of VTE and included in this analysis, only 295 (8.9%) did not receive any anticoagulation at all. Of the remaining 3,016 (91.1%) discharges that did receive anticoagulation, 1,061 (35.2%) received enoxaparin, 1,028 (34.1%) received warfarin, and the remaining 927 (30.7%) received other or combination prophylaxis. However, after discharge only 1,800 (54.4%) of all patients received prophylaxis, with the majority receiving warfarin (1,028, 57.1%). The remaining 1,511 (45.6%) received no outpatient prophylaxis (Table). Conclusion: This analysis presents both inpatient and outpatient VTE prophylaxis patterns in real-world orthopedic surgery patients that are at risk of VTE. Although the rate of prophylaxis was high in inpatients, approximately half of all patients had no prophylaxis post-discharge. Further efforts to improve VTE prevention in discharged orthopedic surgery patients are required. Disclosures: Amin: sanofi-aventis: Research Funding, Speakers Bureau, The authors received editorial/writing support in the preparation of this abstract funded by sanofi-aventis U.S., Inc. . Lin:sanofi-aventis: Employment. Ryan:sanofi-aventis: Research Funding.
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Bobrow, Robert. "Counterpoint to Walach's Review of The Real Anthony Fauci. Bill Gates, Big Pharma, and the Global War on Democracy and Public Health by Robert F. Kennedy, Jr." Journal of Scientific Exploration 36, no. 1 (2022): 195–98. http://dx.doi.org/10.31275/20222471.
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At age 77, I can remember polio. I was terrified of it. Everybody was. A child in perfectly good health suddenly got a fever and the next morning was paralyzed for life. Everyone knew someone who had it. Then a vaccine came out, and this was a Wonderful Thing. Parents eagerly lined up their children to receive it (or a placebo in the earliest phases of its development), and nobody questioned this, as polio was obviously worse than the vaccine could ever be. Republican or Democrat, you did not want to get polio: There were no politics involved. There was also no Facebook.
 Enter COVID. Suddenly 450 beds of my 650-bed hospital contained COVID patients, all of them good and sick. Corpses accumulated faster than they could be disposed of. Local nursing homes saw a majority of their residents die. People were terrified. The country shut down. When a vaccine finally arrived, you would think everyone would rush to get it, and many did. But then a strange and probably unprecedented thing happened: politics supervened. Why not wanting to die should be informed by your political affiliation is still beyond me. By September 2021, 56% of Republicans were fully or partially vaccinated, as opposed to 92% of Democrats [1]. During October/November 2021, an unvaccinated person was 78 times more likely to die of COVID than a fully vaccinated one [2].
 There have been nine deaths attributable to COVID vaccine [3] — all from the Johnson & Johnson product and at the time of this writing, 900,000 deaths from COVID in the United States. Polio vaccine, when the live virus, oral product (Sabin vaccine) was used for the convenience of not having to give a shot, caused five to ten cases of polio/year. For many years this was considered acceptable, compared to the millions of cases prevented. But as American society became more risk-averse, the original Salk vaccine, which did not use live virus but had to be injected, was brought back. Politics, by the way, was not involved in this change. The point is, sometimes vaccines have adverse effects, but are worth it. A child paralyzed by polio, a grandparent dying of COVID—who would not avoid this if they could?
 Against this backdrop, the Editor-in-Chief asked me to examine the review, by Harald Walach of the book The Real Anthony Fauci, Bill Gates, Big Pharma, and the Global War on Democracy and Public Health by Robert F. Kennedy, Jr. I am a conventionally-practicing, university-based family physician.
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C., T. E. "HEALTH HAZARDS OF EXCESSIVE STUDY IN THE BOSTON PUBLIC SCHOOLS (1854)." Pediatrics 84, no. 1 (1989): 93. http://dx.doi.org/10.1542/peds.84.1.93.
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During the mid-nineteenth century American physicians were greatly troubled by what they thought were the evils of excessive academic demands placed on children in our public schools. The editorial below, published in 1854 in the Boston Medical and Surgical Journal, is typical of many of a similar nature. Our city prides itself on the superiority of its public schools; and we think Boston is justly entitled to take the highest rank among the cities of the civilized world for the facilities afforded by its citizens for the education of youth. But notwithstanding the large expenditure of money for the erection of beautiful and commodious school-houses, for mathematical and other instruments, for teachers, &c., all which give a character to our Boston schools, there exists an evil in the present system of educating, which seriously demands attention, and, if possible, a remedy. It is the ambition of the teachers of our schools, to have their scholars thoroughly instructed, and that they may appear well before the committees at examinations; and for that purpose, lessons in great numbers and requiring toilsome study, are imposed upon them. No discrimination is made, as regards the mental or physical capacity of the individual members of the class, but all are required to be perfect in their answers, or else they lose their position in the class and school. Not one fifth of the time devoted to school hours is allowed for study, being occupied in recitations; and the severe tasks the poor children have in getting their lessons must be apparent, when it is known that so long a time is required in reciting them. The scholars of the second class, for instance, have to commit to memory from twelve to twenty-five pages of geography, three to six pages of arithmetic, the same of grammar, three pages in spelling, besides exercises in reading, writing, &c. Now these lessons must be studied out of school, at the time which should be devoted to exercise and recreation. The imposition of such severe tasks upon the young and growing children, must enfeeble their constutions, and often incapacitates them, if they arrive at maturity, for enjoying life. We have seen many children who were ambitious to accomplish all that was required of them by teachers; and to do so, the greatest portion of the twenty-four hours was necessarily devoted to their books, scarcely allowing any time for taking their meals. It must be obvious to every one, that such close application to study, produces, in their turn, a train of diseases which cannot always be eradicated. Aching heads, loss of appetite, sleepless nights, inflamed eyes, with other deviations from health, are the accompaniments and the consequences of excessive mental exertion.
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Quiñones, Miguel A., Pamela S. Douglas, Elyse Foster, et al. "ACC/AHA clinical competence statement on echocardiography11When citing this document, the American College of Cardiology, the American Heart Association, and the American College of Physicians–American Society of Internal Medicine would appreciate the following citation format: Quiñones MA, Douglas PS, Foster E, Gorcsan J, Lewis JF, Pearlman AS, Rychik J, Salcedo EE, Seward J, Stevenson JG, Thys DM, Weitz HH, and Zoghbi WA. ACC/AHA clinical competence statement on echocardiography: a report of the American College of Cardiology/American Heart Association/American College of Physicians–American Society of Internal Medicine Task Force on Clinical Competence (Committee on Echocardiography). J Am Coll Cardiol 2003;41:687–708.22This document was approved by the American College of Cardiology Board of Trustees in December 2002 and the American Heart Association Science Advisory and Coordinating Committee in November 2002.**Address for Reprints: This document is available on the Web sites of the American College of Cardiology (www.acc.org), the American Heart Association (www.americanheart.org), the American Society of Echocardiography (http://asecho.org), and the Society of Pediatric Echocardiography (www.sopeonline.com). Reprints of this document may be purchased for $5.00 each by calling 1-800-253-4636 or by writing to the American College of Cardiology, Resource Center, 9111 Old Georgetown Road, Bethesda, Maryland 20814-1699." Journal of the American College of Cardiology 41, no. 4 (2003): 687–708. http://dx.doi.org/10.1016/s0735-1097(02)02885-1.
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Del Galdo, F., O. Distler, C. Denton, et al. "AB0431 EXPLORING THE UTILITY OF THE AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CRISS IN PATIENTS WITH DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 1244. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1760.
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Background:The ACR Composite Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) was developed to measure the probability of improvement in response to treatment in patients with early diffuse cutaneous SSc (dcSSc), accounting for new/worsening cardiopulmonary involvement and/or renal crisis, and changes in modified Rodnan skin score, forced vital capacity, health assessment questionnaire disability index, and patient’s and physician’s global impressions. In patients with SSc-ILD, treatment response may be reflected as slower progression, stabilisation or improvement.Objectives:Using data from patients with dcSSc and ILD in the placebo group of the SENSCIS trial, we analysed the probability of improvement using the ACR CRISS score at week 52. We also evaluated whether the CRISS numerator could provide information on the spectrum of responses in this patient population.Methods:The SENSCIS trial enrolled subjects with SSc-ILD with onset of first non-Raynaud symptom ≤7 years before screening, FVC ≥40% predicted, and fibrotic ILD ≥10% extent on an HRCT scan. Subjects on prednisone ≤10 mg/day (or equivalent) and/or stable therapy with mycophenolate or methotrexate were allowed to participate. Subjects were randomised to receive nintedanib or placebo. Subjects were not randomised by use of mycophenolate. In patients randomised to receive placebo who had dcSSc and/or mRSS >15 at baseline, we analysed the ACR CRISS and its numerator at week 52 in subgroups by use of mycophenolate at baseline. Analyses were exploratory and descriptive.Results:Of 117 analysed subjects in the placebo group who had dcSSc and/or mRSS >15 at baseline, 60 (51.3%) were taking mycophenolate at baseline. Compared with patients not taking mycophenolate at baseline, those taking mycophenolate had a lower mean age (48.4 [SD 11.8] vs 53.1 [13.4] years), lower mean FVC % predicted (68.8 [17.0] vs 73.0 [14.6]), and a greater proportion were female (76.7% vs 71.9%); median time since first onset of non-Raynaud symptom was similar (3.9 vs 4.5 years, respectively) as was mean (SD) mRSS (16.5 [7.7] vs 15.9 [8.0], respectively). One patient (taking mycophenolate at baseline) had limited cutaneous SSc. At week 52, median (Q1, Q3) ACR CRISS score was 0.036 (0.001, 0.601) in subjects taking mycophenolate and 0.002 (0.000, 0.112) in subjects not taking mycophenolate at baseline, and mean (SD) ACR CRISS score was 0.28 (0.37) in subjects taking mycophenolate and 0.16 (0.31) in subjects not taking mycophenolate at baseline (Figure 1). In these groups, respectively, 25.0% and 14.0% of subjects had CRISS score >0.6 (considered improved) at week 52. The CRISS numerator provided a broader distribution of response values, but was not informative in this patient population.Conclusion:In exploratory analyses, among subjects with dcSSc and ILD who received placebo in the SENSCIS trial, the proportion considered improved at week 52 based on ACR CRISS score was numerically greater in patients taking than not taking mycophenolate at baseline. There remains a need for composite scores that provide better interpretation of the magnitude of response in patients with SSc.Acknowledgements:The SENSCIS trial was funded by Boehringer Ingelheim. Medical writing support was provided by FleishmanHillard Fishburn, London, UK. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE).Disclosure of Interests:Francesco Del Galdo Speakers bureau: Actelion and AstraZeneca, Consultant of: Actelion, AstraZeneca, Boehringer Ingelheim, Capella BioScience, ChemomAb and Mitsubishi Tanabe Pharma, Grant/research support from: Capella BioScience, Kymab and Mitsubishi Tanabe Pharma, Oliver Distler Consultant of: AbbVie, Acceleron Pharma, Amgen, AnaMar, Arxx Therapeutics, Baecon Discovery, Bayer, Blade Therapeutics, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos NV, GlaxoSmithKline, Glenmark Pharmaceuticals, Horizon (Curzion) Pharmaceuticals, Inventiva, IQVIA, Italfarmaco, iQone, Kymera Therapeutics, Lilly, Medac, Medscape, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Roche, Sanofi, Serodapharm, Target Bioscience, Topadur Pharma and UCB, Grant/research support from: Kymera Therapeutics and Mitsubishi Tanabe Pharma, Christopher Denton Speakers bureau: Boehringer Ingelheim, Corbus, Janssen, and Mallinckrodt Pharmaceuticals, Consultant of: Acceleron Pharma, Arxx Therapeutics, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galapagos NV, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mallinckrodt Pharmaceuticals, Roche, Sanofi and UCB, Grant/research support from: Arxx Therapeutics, GlaxoSmithKline and Servier, Yannick Allanore Consultant of: Boehringer Ingelheim, Medsenic, Menarini and Sanofi, Grant/research support from: Alpine Pharmaceuticals, Daniel Wachtlin Employee of: Currently an employee of Boehringer Ingelheim, Margarida Alves Employee of: Currently an employee of Boehringer Ingelheim, Dinesh Khanna Shareholder of: Eicos Sciences, Inc. (less than 5%), Consultant of: Acceleron Pharma, Actelion, AbbVie, Amgen, Bayer, Boehringer Ingelheim, CSL Behring, Corbus, Gilead Sciences, Galapagos NV, Genentech/Roche, GlaxoSmithKline, Horizon Therapeutics, Merck, Mitsubishi Tanabe Pharma, Sanofi-Aventis and United Therapeutics, Grant/research support from: Bayer, Bristol-Myers Squibb, Horizon Therapeutics, Immune Tolerance Network, National Institutes of Health and Pfizer, Employee of: Chief Medical Officer- CiviBioPharma/Eicos Sciences, Inc.
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Teres, Daniel, Keith Boyd, John Rapoport, Martin Strosberg, Robert Baker, and Stanley Lemeshow. "The Impact of Legislation Requiring DNR Orders: New York State Compared with Neighboring States." Journal of Intensive Care Medicine 11, no. 6 (1996): 335–42. http://dx.doi.org/10.1177/088506669601100605.
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Decisions to place limitations on the care of patients are complex, and they often involve physicians, other medical professionals, patients, or a surrogate decision-maker, family members, and others. In 1988, the Joint Commission on Accreditation of Health Care Organizations (JCAHO) and the New York State government adopted two different approaches to this complex issue of do-not-resuscitate (DNR) orders: one involved professional self-regulation, whereas the other mandated a standardized procedure requiring completion of legal documents. This study examines the impact of these two different approaches to writing of DNR orders for adult intensive care unit (ICU) patients on utilization and resulting length of stay. The study used three data bases. One is from a larger study designed to update the Mortality Probability Model (MPM), a measure of severity of illness for ICU patients. This data base includes consecutive admissions to the adult ICUs of four hospitals in the northeastern United States. The second is a similar data base from the European-North American Study of Severity Systems (ENAS), and it includes 20 hospitals. The third data base, a 1991 national survey of ICUs by the Society of Critical Care Medicine (SCCM), lists characteristics of patients in ICUs in the United States on a specific day. Logistic regression was used to analyze the first two data bases; the percentage of patients in New York with DNR orders was calculated for each of the three data bases and compared with patients in neighboring states. Length of ICU and hospital stay was measured in the first two data sets. In the MPM data, 14.4% of medical patients in New York had a DNR order written at the time of ICU discharge, compared with 198% of medical patients in Massachusetts; and 4.3% of New York surgical patients had a DNR order written at the time of ICU discharge, compared with 8.3% of surgical patients in Massachusetts. In the ENAS data, 7.4% of New York nonoperative patients has a DNR order in place within 24 hours, compared with 8.4% of such patients in the other states; and 1.0% of New York operative patients had DNR orders, compared with 3–5% of operative patients from other states. Logistic regression revealed that a New York patient was less likely to have a DNR order written than a patient located in one of the other states studied. Data from the SCCM survey demonstrated that the New York percentage of patients with “no CPR” orders was 5.50%, compared with a percentage of 6.87% in other states. With few exceptions, these differences between New York and surrounding states did not have an impact on hospital length of stay. During the period studied following implementation of New York's DNR Law, utilization of DNR orders in New York State was significantly lower than neighboring states. This decreased utilization, however, did not effect hospital utilization as measured through length of stay and ICU admissions.
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Quiñones, Miguel A., Pamela S. Douglas, Elyse Foster, et al. "ACC/AHA clinical competence statement on echocardiography1232Reprinted from J Am Coll Cardiol 2003;41:687-708 with permission.This document was approved by the American College of Cardiology Board of Trustees in December 2002 and the American Heart Association Science Advisory and Coordinating Committee in November 2002. 1When citing this document, the American College of Cardiology, the American Heart Association, and the American College of Physicians–American Society of Internal Medicine would appreciate the following citation format: Quiñones MA, Douglas PS, Foster E, Gorcsan J, Lewis JF, Pearlman AS, Rychik J, Salcedo EE, Seward J, Stevenson JG, Thys DM, Weitz HH, and Zoghbi WA. ACC/AHA clinical competence statement on echocardiography: a report of the American College of Cardiology/American Heart Association/American College of Physicians–American Society of Internal Medicine Task Force on Clinical Competence (Committee on Echocardiography). J Am Coll Cardiol 2003;41:687–708. *Address for Reprints: This document is available on the Web sites of the American College of Cardiology (www.acc.org), the American Heart Association (www.americanheart.org), the American Society of Echocardiography (http://asecho.org), and the Society of Pediatric Echocardiography (www.sopeonline.com). Reprints of this document may be purchased for $5.00 each by calling 1-800-253-4636 or by writing to the American College of Cardiology, Resource Center, 9111 Old Georgetown Road, Bethesda, Maryland 20814-1699." Journal of the American Society of Echocardiography 16, no. 4 (2003): 379–402. http://dx.doi.org/10.1016/s0894-7317(03)00113-5.
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Bjork, M., I. Thyberg, A. Kastbom, et al. "AB0400 PATIENT-REPORTED OUTCOME MEASURES IN SWEDISH PATIENTS WITH RECENT-ONSET SLE VERSUS RA IN THE FIRST 60 MONTHS AFTER DIAGNOSIS." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 1499.2–1500. http://dx.doi.org/10.1136/annrheumdis-2020-eular.321.
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Background:Patient (pt)-reported outcome measures (PROMs) provide information on a pt’s own perception of disease impact, helping to provide a global perspective of disease when combined with conventional physician assessments. There is a discrepancy in PROMs between pts with rheumatoid arthritis (RA) and those with systemic lupus erythematosus (SLE); improvements in PROMs are often seen within the first year after diagnosis among pts with RA,1but not SLE.2Whether this discrepancy persists during subsequent years is unknown.Objectives:To compare changes in PROMs among pts with SLE versus RA within the first 60 months after diagnosis.Methods:Pts with SLE with no prior organ damage were consecutively enrolled (2010–2015) from the Clinical Lupus Register in Northeastern Gothia and met the ≥4 of the 1982 American College of Rheumatology (ACR) and/or the 2012 Systemic Lupus International Collaborating Clinics classification criteria. Pts with RA were included from the observational 2nd Management of Early Intervention in RA cohort (TIRA-2; 2006–2009),3which enrolled pts with recent-onset RA; 84% of patients fulfilled the 1987 ACR criteria. Pts in both cohorts had symptoms for <12 months prior to diagnosis/inclusion and were treated according to Swedish guidelines. Pts with SLE or RA were followed prospectively after diagnosis. PROMs (quality of life: EuroQoL-5 Dimensions [EQ-5D]; activity limitations: Health Assessment Questionnaire [HAQ]; pain, fatigue, and well-being: Visual Analogue Scale 0–100 mm) were collected at Months 0 (inclusion), 6, 12, 24, 36, 48, and 60. HAQ, pain, fatigue, well-being: higher scores indicate greater severity; EQ-5D: lower scores indicate greater severity.Results:41 pts with SLE and 522 pts with RA were included in this analysis. Numerical differences between cohorts in age, sex, and tobacco smoking were seen (Table). Baseline PROM scores were generally worse for pts with RA versus SLE (Figs 1 and 2). However, an improvement in PROM scores was seen by Month 6 for pts with RA, but not SLE. Between Months 6 and 60, PROM scores remained largely unchanged for both groups.Conclusion:PROMs in pts with early SLE tended to remain stable in the years following diagnosis compared with the improvement experienced by pts with early RA, indicating a greater unmet need in SLE. The lack of improvement in PROMs in pts with SLE may be due to the disease’s impact across multiple organ systems, which may take longer to resolve versus RA symptoms. These results imply there is room for improvement in disease management – both pharmacological and multi-professional interventions. Data should be interpreted with caution due a low number of pts with SLE.References:[1]Versteeg GA et al.Clin Rheumatol.2018;37:1189-1197.[2]Heijke R et al.Arthritis Rheumatol.2018;70 (suppl 10):abstract 2633.[3]Hallert E et al.Scand J Rheumatol.2015;44:100-105.CharacteristicSLE(n=41)RA(n=522)Age, median (interquartile range), years39.0 (18–77)60.0 (51–68)Female sex33 (80.5)352 (67.4)White35 (85.4)NCPrevious or current tobacco smoking18 (43.9)183 (65.6)*Fulfilled 1982 ACR SLE classification criteria36 (87.8)NANumber of fulfilled ACR SLE criteria, mean (range)4.7 (3–9)NAFulfilled 2012 SLICC classification criteria41 (100)NAFulfilled 1987 ACR RA criteriaNA439 (84.1)Data are n (%) unless otherwise specified.*n=279.ACR=American College of Rheumatology; NA=not available; NC=not collected due to ethics approval; RA=rheumatoid arthritis; SLE=systemic lupus erythematosus; SLICC=Systemic Lupus International Collaborating Clinics.Acknowledgments:Sreeram Ramagopalan (supervised analysis). Lola Parfitt (medical writing, Caudex; funding: BMS)Disclosure of Interests:Mathilda Bjork: None declared, Ingrid Thyberg: None declared, Alf Kastbom Consultant of: Bristol-Myers Squibb, Pfizer, Roche, UCB, Employee of: Sanofi, Speakers bureau: Bristol-Myers Squibb, UCB, Rebecca Heijke: None declared, Laura McDonald Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Evo Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Christopher Sjowall: None declared
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Creager, Mark A., Jerry Goldstone, John W. Hirshfeld, et al. "ACC/ACP/SCAI/SVMB/SVS clinical competence statement on vascular medicine and catheter-based peripheral vascular interventions11When citing this document, the American College of Cardiology, American College of Physicians, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and the Society for Vascular Surgery would appreciate the following citation format: Creager MA, Goldstone J, Hirshfeld JW, Kazmers A, Kent KC, Lorell BH, Olin JW, Pauly RR, Rosenfield K, Roubin GS, Sicard GA, and White CJ. ACC/ACP/SCAI/SVMB/SVS clinical competence statement on vascular medicine and catheter-based peripheral vascular interventions: a report of the American College of Cardiology/American Heart Association/American College of Physicians Task Force on Clinical Competence (ACC/ACP/SCAI/SVMB/SVS Writing Committee on Clinical Competence on Peripheral Vascular Disease). J Am Coll Cardiol 2004;44:941–57.33copies: this document is available on the world wide web sites of the american college of cardiology (www.acc.org), american college of physicians (www.acponline.org), society for cardiovascular angiography and interventions (www.scai.org), society for vascular medicine and biology (www.svmb.org), and the society for vascular surgeons (www.vascularweb.org). single copies of this document may be purchased for $10.00 by calling 1-800-253-4636 or by writing to the american college of cardiology, educational services, 9111 old georgetown road, bethesda, maryland 20814-1699. permissions: multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the american college of cardiology foundation. please direct requests to copyright_permissions@acc.org." Journal of the American College of Cardiology 44, no. 4 (2004): 941–57. http://dx.doi.org/10.1016/j.jacc.2003.10.012.
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Kadish, Alan H., Alfred E. Buxton, Harold L. Kennedy, et al. "ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography41This document was approved by the American College of Cardiology Board of Trustees in November 2001 and the American Heart Association Science Advisory and Coordinating Committee in August 2001.42When citing this document, the American College of Cardiology and the American Heart Association would appreciate the following citation format: Kadish AH, Buxton AE, Kennedy HL, Knight BP, Mason JW, Schuger CD, Tracy CM. ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography: a report of the American College of Cardiology/American Heart Association/American College of Physicians-American Society of Internal Medicine Task Force on Clinical Competence (ACC/AHA Committee to Develop a Clinical Competence Statement on Electrocardiography and Ambulatory Electrocardiography); J Am Coll Cardiol 2001;38:2091–100.43This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org) and the American Heart Association (www.americanheart.org). Reprints of this document may be purchased for $5.00 each by calling 1-800-253-4636 or by writing to the American College of Cardiology, Educational Services, 9111 Old Georgetown Road, Bethesda, Maryland 20814-1699.44© 2001 by the American College of Cardiology and American Heart Association, Inc." Journal of the American College of Cardiology 38, no. 7 (2001): 2091–100. http://dx.doi.org/10.1016/s0735-1097(01)01680-1.
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Shafrir, A. L., L. A. Wise, J. R. Palmer, et al. "Validity of self-reported endometriosis: a comparison across four cohorts." Human Reproduction 36, no. 5 (2021): 1268–78. http://dx.doi.org/10.1093/humrep/deab012.
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Abstract STUDY QUESTION How accurately do women report a diagnosis of endometriosis on self-administered questionnaires? SUMMARY ANSWER Based on the analysis of four international cohorts, women self-report endometriosis fairly accurately with a &gt; 70% confirmation for clinical and surgical records. WHAT IS KNOWN ALREADY The study of complex diseases requires large, diverse population-based samples, and endometriosis is no exception. Due to the difficulty of obtaining medical records for a condition that may have been diagnosed years earlier and for which there is no standardized documentation, reliance on self-report is necessary. Only a few studies have assessed the validity of self-reported endometriosis compared with medical records, with the observed confirmation ranging from 32% to 89%. STUDY DESIGN, SIZE, DURATION We compared questionnaire-reported endometriosis with medical record notation among participants from the Black Women’s Health Study (BWHS; 1995-2013), Etude Epidémiologique auprès de femmes de la Mutuelle Générale de l’Education Nationale (E3N; 1990-2006), Growing Up Today Study (GUTS; 2005–2016), and Nurses’ Health Study II (NHSII; 1989–1993 first wave, 1995–2007 second wave). PARTICIPANTS/MATERIALS, SETTING, METHODS Participants who had reported endometriosis on self-administered questionnaires gave permission to procure and review their clinical, surgical, and pathology medical records, yielding records for 827 women: 225 (BWHS), 168 (E3N), 85 (GUTS), 132 (NHSII first wave), and 217 (NHSII second wave). We abstracted diagnosis confirmation as well as American Fertility Society (AFS) or revised American Society of Reproductive Medicine (rASRM) stage and visualized macro-presentation (e.g. superficial peritoneal, deep endometriosis, endometrioma). For each cohort, we calculated clinical reference to endometriosis, and surgical- and pathologic-confirmation proportions. MAIN RESULTS AND THE ROLE OF CHANCE Confirmation was high—84% overall when combining clinical, surgical, and pathology records (ranging from 72% for BWHS to 95% for GUTS), suggesting that women accurately report if they are told by a physician that they have endometriosis. Among women with self-reported laparoscopic confirmation of their endometriosis diagnosis, confirmation of medical records was extremely high (97% overall, ranging from 95% for NHSII second wave to 100% for NHSII first wave). Importantly, only 42% of medical records included pathology reports, among which histologic confirmation ranged from 76% (GUTS) to 100% (NHSII first wave). Documentation of visualized endometriosis presentation was often absent, and details recorded were inconsistent. AFS or rASRM stage was documented in 44% of NHSII first wave, 13% of NHSII second wave, and 24% of GUTS surgical records. The presence/absence of deep endometriosis was rarely noted in the medical records. LIMITATIONS, REASONS FOR CAUTION Medical record abstraction was conducted separately by cohort-specific investigators, potentially introducing misclassification due to variation in abstraction protocols and interpretation. Additionally, information on the presence/absence of AFS/rASRM stage, deep endometriosis, and histologic findings were not available for all four cohort studies. WIDER IMPLICATIONS OF THE FINDINGS Variation in access to care and differences in disease phenotypes and risk factor distributions among patients with endometriosis necessitates the use of large, diverse population samples to subdivide patients for risk factor, treatment response and discovery of long-term outcomes. Women self-report endometriosis with reasonable accuracy (&gt;70%) and with exceptional accuracy when women are restricted to those who report that their endometriosis had been confirmed by laparoscopic surgery (&gt;94%). Thus, relying on self-reported endometriosis in order to use larger sample sizes of patients with endometriosis appears to be valid, particularly when self-report of laparoscopic confirmation is used as the case definition. However, the paucity of data on histologic findings, AFS/rASRM stage, and endometriosis phenotypic characteristics suggests that a universal requirement for harmonized clinical and surgical data documentation is needed if we hope to obtain the relevant details for subgrouping patients with endometriosis. STUDY FUNDING/COMPETING INTEREST(S) This project was supported by Eunice Kennedy Shriver National Institute of Child Health and Development grants HD48544, HD52473, HD57210, and HD94842, National Cancer Institute grants CA50385, R01CA058420, UM1CA164974, and U01CA176726, and National Heart, Lung, and Blood Institute grant U01HL154386. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. AS, SM, and KT were additionally supported by the J. Willard and Alice S. Marriott Foundation. MK was supported by a Marie Curie International Outgoing Fellowship within the 7th European Community Framework Programme (#PIOF-GA-2011-302078) and is grateful to the Philippe Foundation and the Bettencourt-Schueller Foundation for their financial support. Funders had no role in the study design, conduct of the study or data analysis, writing of the report, or decision to submit the article for publication. LA Wise has served as a fibroid consultant for AbbVie, Inc for the last three years and has received in-kind donations (e.g. home pregnancy tests) from Swiss Precision Diagnostics, Sandstone Diagnostics, Kindara.com, and FertilityFriend.com for the PRESTO cohort. SA Missmer serves as an advisory board member for AbbVie and a single working group service for Roche; neither are related to this study. No other authors have a conflict of interest to report. Funders had no role in the study design, conduct of the study or data analysis, writing of the report, or decision to submit the article for publication. TRIAL REGISTRATION NUMBER N/A.
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Bando, Hiroshi. "Clinical Management for Diabetes Associated with the Concept of Socioeconomic Status (SES)." Journal of Health Care and Research 2, no. 2 (2021): 119–21. http://dx.doi.org/10.36502/2021/hcr.6195.
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Diabetes mellitus has become a medical and social problem. For better diabetic management and improvement of the health care system, the concept of social determinants of health (SDOH) and socioeconomic status (SES) would be required. SES includes adequate diabetes care, medical cost, health condition, and regular access to care and cure. World Health Organization (WHO) has continued the prevention and management of diabetes and proposed the Global Diabetes Compact in last 2020 [1]. The purpose of the Compact includes several items, such as i) to leverage present capacities in the healthcare system, ii) to meet people’s needs more holistic way, iii) to promote efforts to prevent diabetes especially the young generation, and others. A successful key would be the combined action among public, private, and philanthropic associations. Diabetes mellitus has been a growing medical and social problem in all countries and districts worldwide [2]. The socio economic gradient for diabetic prevalence is shown in high income countries [3]. Further, this gradient seems to be continued for a long despite the improvement of the health care system in those countries [4,5]. In this paper, we describe the social determinants of health (SDOH) and socioeconomic status (SES), among other axes of symmetry for diabetes. In medical practice and health care, population based and value based care have been emphasized. Then, the concept of social determinants of health (SDOH) has been gradually known for an intervention target for estimating health equity [6]. Recently, some comments for SDOH were proposed from medical associations, such as the Society of General Internal Medicine, the American College of Physicians, and other organizations [7]. Moreover, the action perspectives tend to focus on the determinants for individuals and policy [8,9]. In diabetic practice, some basic matters exist including prevalence, incidence, adequate therapy, and economic problems [10]. ADA presented a comment about socio ecological determinants of diabetes. Successively, ADA had an advanced health improvement project for the diabetes writing committee. It has the goal of clarifying diabetic risk and outcomes, academic literature for SDOH [11]. From previous literature, SDOH covers certain areas as follows [6]: i) social context (social support, relationship, and capital, social relationship), ii) health care (quality, accessibility, affordability), iii) local and physical circumstance (residence condition, building environment), iv) food environment (insecurity for food, accessibility for food) and v) socio economic condition (occupation, education, income). According to academic reports, the health disparities for diabetes have been present in the light of adverse influence [12]. Social and environmental factors have been summarized as SDOH in WHO [13]. Among them, social environments seem to be rather main factors. They include societal and community context [14], social capital, social cohesion, and social elements [15]. Health care has been found as an SDOH in the Healthy People 2020, WHO, County health rankings models, associated with accessible factors. WHO regards the health system as one of the SDOH which can give a message of determinants of several health outcomes [15]. On the other hand, it is socioeconomic status (SES) that may influence all related aspects of diabetic treatment in the clinical practice [16]. Actually, lower SES diabetic cases are likely to have some barriers to adequate diabetes care, including medical cost, unsatisfactory health condition, and regular access to care and cure [17]. SES has revealed the multidimensional construct, associated with the occupational, economic, and educational situation [18]. SES has been related to all factors of SDOH [13]. They include medical care, health care, nutrition, social resources, housing, transportation, and so on. The factors of SES and diabetes were investigated for observational studies [19]. It included 28 investigations including diabetic complications, retinopathy, cardiopathy, and others. In summary, SDOH and SES concerning diabetes were introduced. This information will be hopefully useful for developing a bio psycho social perspective in clinical practice.
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Abreu, M., O. Monticielo, V. Fernandes, et al. "POS0747 MAPPING THE NATIONWIDE CLINICAL PROFILE AND PATTERNS OF CARE OF SLE IN BRAZIL – FINDINGS FROM THE MACUNAÍMA STUDY." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 625.2–626. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2421.
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Background:Systemic lupus erythematosus (SLE) is an autoimmune disease with wide clinical variability. Brazil has vast regional diversity, both from an ethnic and socio-cultural point of view.Objectives:To map the clinical profile of SLE in Brazil and explore how this distribution is associated with regional disparities.Methods:This cross-sectional study (GSK Study 207353) evaluated 300 Brazilian patients ≥18 years old with SLE (American College of Rheumatology [ACR] criteria, 1997) who had been under SLE care for ≥1 year. Five SLE reference teaching facilities were selected, one in each of the following Brazilian regions: North (NO), Northeast (NE), Midwest (CO), Southeast (SE), and South (SU). Each region included 60 patients. Clinical and demographic characteristics, and patterns of care were measured through questionnaires completed by physicians or nurses. The SLE Disease Activity Index (SLEDAI) score described disease activity and the Systemic Lupus International Collaborating Clinics/ACR Damage Index (SDI) described damage accrual. To assess the potential association between regional disparities and clinical outcomes, a hospitalisation profile was described. A bootstrapping approach of logistic regression was used to explore potential factors associated with hospitalisation.Results:Overall, 92.3% of patients were female, with a mean (standard deviation; SD) age of 41.8 (12.7) years and a mean (SD) disease duration of 11.8 (7.9) years. Overall, 161 (53.7%) patients were of Latino origin; in the NO this proportion was 88%. White patients predominated in the SU (58.3%); and black patients in the SE (31.7%). The mean (SD) number of years of schooling was 11.3 (4.6), and was highest in the NO (14.2 [3.6]) and lowest in the SU (9.0 [4.0]; p<0.001). With regard to the distribution of the SLE clinical profile according to ACR criteria, arthritis was found in 221 patients and predominated in all regions (mean 73.7%), with a lower prevalence in the CO (40%; p<0.001; Figure 1A). The mean (SD) SLEDAI score was 4.33 (5.39) at the time of interview. The main contributing factors to disease activity, according to SLEDAI, were complement consumption (18%), arthritis (15.3%), and alopecia (15%). The SDI scale was scored for cataracts (15%), proteinuria (8.7%), and thrombosis (7.3%). Among the associated comorbidities, hypertension was predominant in the NO (35%; p=0.001). Smoking predominated in the SU (23%; p<0.001); obesity (27%; p=0.059) and dyslipidemia (35%; p=0.023), in the SE. Regarding patterns of care (Figure 1B), antimalarials were most frequently prescribed in the SE (88.3%) and the SU (91.7%). Corticosteroids prevailed in the NO (96.7%). The mean (SD) time between home and care facility was 4.5 (12.6) hours. Patients in the NO reported the longest transport time to reach the care facility (11.5 [25.4] hours; p<0.001). The hospitalisation rate during the study period was 21.3% across all regions, with no statistical difference between centres (p=0.651). Reasons for hospitalisation included disease activity (36 [12%]), infection (19 [6.3%]), surgery (10 [3.3%]), and management of clinical morbidities (6 [2.0%]). Hospitalisation was associated with ethnicity (p<0.016), occupational status (p<0.001), age (p=0.02), and the use of hydroxychloroquine (HCQ) or chloroquine (CQ; p<0.001).Conclusion:This nationwide study highlights ethnic, social, and patterns-of-care disparities among Brazilian patients with SLE. The modelling shows evidence that such disparities contribute to the divergent clinical spectrum observed in Brazil.Funding:GSKFigure 1.Distribution of the A) Brazilian SLE clinical profile according to the ACR Classification Criteria and B) Brazilian prescriptive profile for SLE treatment according to the use of immunosuppressive drugs, biological agents, and corticosteroids during the study (12 months)ANA, antinuclear antibodyAcknowledgements:Medical writing assistance was provided by Helen Taylor, Fishawack Indicia Ltd., UK, part of Fishawack Health, and was funded by GSK.Disclosure of Interests:Mirhelen Abreu Grant/research support from: GSK, Amgen, Biogen, Libbs, Odirlei Monticielo Speakers bureau: GSK, AbbVie, UCB, Roche, Novartis, Consultant of: GSK, AbbVie, Janssen, Vander Fernandes Speakers bureau: Janssen, Novartis, Roche, AbbVie, Pfizer, Grant/research support from: Novartis, GSK, Pfizer, Alexandre Cristovão Maiorano: None declared, Fernando dos Santos Beserra: None declared, Flavia Lamarao Employee of: GSK, Nathalie David Shareholder of: GSK, Employee of: GSK, Bruna de Veras Employee of: GSK, Blanca Bica: None declared, Domingos Sávio Nunes de Lima Grant/research support from: GSK, Marta Maria das Chagas Medeiros: None declared
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Balsa, A., S. Wassenberg, A. Tournadre, et al. "POS0518 EFFECT OF FILGOTINIB (FIL) ON BODY WEIGHT (BW) AND BODY MASS INDEX (BMI) AND EFFECT OF BASELINE BMI ON THE EFFICACY AND SAFETY OF FIL IN RHEUMATOID ARTHRITIS (RA)." Annals of the Rheumatic Diseases 81, Suppl 1 (2022): 516–17. http://dx.doi.org/10.1136/annrheumdis-2022-eular.1088.
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BackgroundFIL is a Janus kinase (JAK) 1 preferential inhibitor approved for the treatment (tx) of moderate to severe RA. Weight gain has been reported with other JAK inhibitors1–3; it is important to describe the effect of FIL on BW/BMI for physicians to correctly inform and appropriately treat patients.ObjectivesOur primary aim was to assess the effect of FIL on BW/BMI using data from the FINCH 1–3 studies. Secondary aims were to assess the efficacy and safety of FIL according to baseline BMI.MethodsFINCH 1–3 (NCT02889796, NCT02873936, NCT02886728) were phase 3, randomised, double-blind, active/placebo (PBO)-controlled studies of FIL 100/200 mg (FIL100/FIL200) ± methotrexate (MTX) in patients with active RA who had an inadequate response to MTX (FINCH 1) or biologic DMARD (FINCH 2), or were MTX naïve (FINCH 3). We assessed changes from baseline (CFB) in BW and BMI by tx group and baseline BMI, and the efficacy and safety of FIL by baseline BMI (<25, 25–<30 or ≥30 kg/m2). Efficacy measures included American College of Rheumatology (ACR)20/50/70 response, Disease Activity Score 28 with C-reactive protein (DAS28-CRP) and health assessment questionnaire disability index (HAQ-DI). Safety data were from 7 RA clinical trials (FINCH 1–4, DARWIN 1–3)4.ResultsIn FINCH 1–3, baseline disease characteristics such as HAQ-DI, DAS28-CRP and clinical disease activity index were similar across BMI subgroups for each tx group. There were no clinically relevant CFB in median BW or BMI in any tx group or differences between tx groups. Mean CFB in BMI (kg/m2) were 0.4 with FIL200 and FIL100 and 0.3 with adalimumab (ADA) at Week 52 in FINCH 1; 0.2, 0.6 and −0.1 with FIL200, FIL100 and PBO, respectively, at Week 24 in FINCH 2; and 0.5, 0.6, 1.1 and 0.3 with FIL200+MTX, FIL100+MTX, FIL200 and MTX, respectively, at Week 52 in FINCH 3.CFB in BMI did not appear dependent on baseline BMI. FIL200±MTX was efficacious vs controls regardless of baseline BMI for most measures at each timepoint. In FINCH 1, in the <25, 25–<30 and ≥30 kg/m2 BMI subgroups, DAS28-CRP <2.6 was achieved by 38%, 29% and 33% of the FIL200 group, 29%, 19% and 21% of the ADA group, and 7%, 10% and 11% of the PBO group at Week 12, respectively. Figure 1 shows ACR20 responders by baseline BMI in FINCH 1–3. Integrated safety data across baseline BMI subgroups are summarised in Table 1. VTE rate was numerically higher with FIL200 in the ≥30 than 25–<30 or <25 kg/m2 BMI subgroups; serious infection rate was numerically higher with FIL100 in the <25 mg/m2 subgroup vs other BMI subgroups.Table 1.Exposure-adjusted incidence rate (95% CI) of AEs per 100 PYE by baseline BMIFIL dose (mg)BMI (kg/m2)<2525–<30≥30PYE 3062.8PYE 2640.1PYE 2382.2TEAEs20034.5 (32.0, 37.1)35.7 (33.0, 38.6)36.6 (33.7, 39.8)10044.3 (40.4, 48.6)43.0 (38.9, 47.5)45.3 (41.1, 50.0)Serious TEAEs2005.3 (4.4, 6.4)5.8 (4.8, 7.1)7.1 (5.8, 8.5)1007.6 (6.0, 9.4)6.5 (5.0, 8.4)8.1 (6.4, 10.2)Deaths2000.3 (0.2, 0.7)0.5 (0.3, 1.0)0.5 (0.2, 1.0)1000.4 (0.1, 1.0)0.3 (0.1, 1.0)0.2 (0.1, 0.9)Venous thrombotic and embolic events2000.1 (0.0, 0.4)0.1 (0.0, 0.5)0.5 (0.2, 1.0)1000.1 (0.0, 0.7)0.1 (0.0, 0.8)0.2 (0.1, 0.9)Major adverse cardiovascular events2000.3 (0.2, 0.7)0.3 (0.1, 0.7)0.5 (0.2, 1.0)1000.6 (0.3, 1.3)0.3 (0.1, 1.0)0.6 (0.2, 1.4)Serious infections2001.1 (0.7, 1.7)1.7 (1.2, 2.5)1.8 (1.2, 2.6)1002.6 (1.8, 3.9)1.2 (0.7, 2.2)2.2 (1.4, 3.4)Herpes zoster2001.6 (1.1, 2.2)1.4 (1.0, 2.1)1.8 (1.2, 2.6)1001.0 (0.5, 1.8)1.2 (0.7, 2.2)1.0 (0.5, 2.0)Malignancy excluding nonmelanoma skin cancer2000.5 (0.3, 1.0)0.7 (0.4, 1.3)0.5 (0.3, 1.1)1000.6 (0.3, 1.3)0.4 (0.2, 1.2)0.8 (0.4, 1.7)BMI, body mass index; FIL, filgotinib; PYE, patient years of exposure; (TE)AE, (treatment-emergent) adverse eventConclusionFIL did not substantially affect CFB in BW or BMI. FIL200±MTX was generally more efficacious vs controls regardless of baseline BMI, and the rate of TEAEs was similar across baseline BMI subgroups.References[1]Tofacitinib SmPC[2]Baracitinib SmPC[3]Upadacitinib SmPC[4]Winthrop K, et al. ACR 2021. Abstract 1698AcknowledgementsThe FINCH studies were funded by Gilead Sciences (Foster City, CA, United States).We thank the physicians and patients who participated in the studies.Medical writing support was provided by Debbie Sherwood, BSc (Aspire Scientific Ltd, Bollington, UK) and funded by Galapagos NV (Mechelen, Belgium).Disclosure of InterestsAlejandro Balsa Speakers bureau: AbbVie, Galapagos, Gilead, Lilly, Nordic, Pfizer, Sandoz, and UCB, Consultant of: AbbVie, Galapagos, Lilly, Nordic, Pfizer, and UCB, Grant/research support from: AbbVie, Pfizer, UCB, Siegfried Wassenberg Speakers bureau: AbbVie, MSD, Pfizer, and Sanofi, Consultant of: AbbVie, Gilead, Lilly, Nichi-Iko, Pfizer, and UCB, Grant/research support from: Pfizer, Anne Tournadre Speakers bureau: Fresenius-Kabi and Sanofi, Paid instructor for: Fresenius-Kabi, Consultant of: AbbVie, Fresenius-Kabi, Lilly, Novartis, and Sanofi, Grant/research support from: Novartis, Pfizer, and UCB, Hans-Dieter Orzechowski Employee of: Galapagos, Katrien Van Beneden Shareholder of: Galapagos, Employee of: Galapagos, Vijay Rajendran Employee of: Galapagos, Udo Lendl Employee of: Galapagos, Pieter-Jan Stiers Shareholder of: Galapagos, Employee of: Galapagos, Chris Watson Shareholder of: Galapagos, Employee of: Galapagos, Roberto Caporali Speakers bureau: AbbVie, Accord, BMS, Celltrion, Fresenius-Kabi, Galapagos, Lilly, MSD, Novartis, Pfizer, Sandoz, and UCB, Consultant of: AbbVie, Accord, BMS, Celltrion, Fresenius-Kabi, Galapagos, Lilly, MSD, Novartis, Pfizer, Sandoz, and UCB, Patrick Verschueren Speakers bureau: Eli Lilly, Galapagos, MSD, and Roularta, Consultant of: AbbVie, BMS, Celltrion, Eli Lilly, Galapagos, Gilead, Nordic Pharma, Pfizer, Sidekick Health, and UCB, Grant/research support from: Pfizer Chair Management of Early Rheumatoid Arthritis at KU Leuven Belgium.
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Mease, P. J., A. Deodhar, D. Van der Heijde, et al. "OP0227 EFFICACY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 INHIBITOR, IN MUSCULOSKELETAL MANIFESTATIONS OF ACTIVE PSORIATIC ARTHRITIS IN A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 137–38. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2653.
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Background:Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates IL-23, IL-12, and IFNα/β signaling. Deucravacitinib is a novel, oral selective inhibitor of TYK2 acting via the TYK2 regulatory domain. Phase 2 results showed deucravacitinib was efficacious and well tolerated versus placebo (PBO) in patients with active psoriatic arthritis (PsA).Objectives:This analysis further evaluated improvements in musculoskeletal disease manifestations in patients in the Phase 2 PsA trial.Methods:The ongoing Phase 2 trial (NCT03881059) enrolled patients who had a PsA diagnosis for ≥6 months, met CASPAR criteria, had active disease (≥3 tender joints, ≥3 swollen joints, C-reactive protein [CRP] ≥3 mg/L), and had at least 1 active skin lesion. Patients either failed or were intolerant to at least 1 nonsteroidal anti-inflammatory drug, corticosteroid, conventional synthetic disease-modifying antirheumatic drug, and/or 1 TNF inhibitor (TNFi; ≤30%). Patients were randomized 1:1:1 to deucravacitinib 6 mg QD or 12 mg QD or PBO, and stratified by TNFi status (experienced vs naive) and body weight (<90 vs ≥90 kg). The primary endpoint, ACR20 response at Week 16, was met and significant improvements in enthesitis vs PBO were observed. The current prespecified subgroup analysis assessed the likelihood of achieving ACR20 response at Week 16 based on study stratification factors. A post hoc analysis evaluated mean change from baseline to Week 16 in ACR components (tender joint count, swollen joint count, Physician’s Global Assessment of PsA, Patients’ Global Assessment of disease activity, Patients’ Global Assessment of pain, high-sensitivity CRP [hCRP], and HAQ-DI score). Analyses were descriptive using data as observed.Results:Patients treated with deucravacitinib were numerically more likely to achieve ACR20 response at Week 16 compared with PBO-treated patients regardless of TNFi experience or body weight, although some of these groups were small (Figure). Improvements for deucravacitinib 6 mg and 12 mg QD versus PBO were observed in all ACR components, with apparent separation occurring as early as Week 4 on, for example, HAQ-DI (mean change from baseline, -0.2 vs -0.2 vs -0.1, respectively) and hCRP (mean change from baseline, -7.4 vs -5.2 vs 0.3, respectively) and maintained through Week 16 (Table).Table 1.Mean (SD) change from baseline for ACR componentsTJCSJCPtGAPainPGAHAQ-DIhCRPBaselineaPBO16.9 (9.8)10.5 (7.7)66.2 (15.8)64.9 (18.2)63.8 (14.8)1.3 (0.6)20.4 (39.1)DEUC 618.1 (10.3)11.9 (7.0)68.2 (16.8)63.6 (21.7)68.2 (14.7)1.3 (0.6)17.6 (23.6)DEUC1219.4 (11.8)11.3 (9.0)63.6 (15.6)63.8 (15.9)63.3 (16.1)1.3 (0.6)16.5 (21.7)Week 16bPBO-4.6 (9.7)-4.3 (8.0)-13.4 (23.5)-13.8 (21.5)-19.9 (21.8)-0.1 (0.4)-3.3 (22.6)DEUC 6-9.3 (9.7)-7.7 (5.8)-28.7 (23.1)-25.3 (26.1)-33.6 (23.0)-0.4 (0.5)-14.2 (24.5)DEUC 12-12.2 (10.2)-8.5 (9.1)-27.6 (25.8)-27.5 (25.0)-32.2 (25.0)-0.4 (0.6)-10.9 (22.8)PBO, n/N=58/66; DEUC 6, n/N=63/70; DEUC 12, n/N=59/67; n/N = number of patients who completed treatment/number of patients randomized; the number of patients with data available for individual components at each time point may vary.aMean (SD). bMean (SD) change from baseline.ACR, American College of Rheumatology; DEUC 6, deucravacitinib 6 mg QD; DEUC 12, deucravacitinib 12 mg QD; HAQ-DI, Health Assessment Questionnaire-Disability Index total score; hCRP, high-sensitivity C-reactive protein; PBO, placebo; PGA, Physician’s Global Assessment of psoriatic arthritis; PtGA, Patients’ Global Assessment of disease activity; QD, once daily; SJC, swollen joint count; TJC, tender joint count.Conclusion:Analyses confirmed the efficacy of deucravacitinib versus PBO across TNFi and body weight subgroups. With deucravacitinib treatment, improvements were displayed in all ACR components.Acknowledgements:This study was sponsored by Bristol Myers Squibb. Professional medical writing assistance was provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb.Disclosure of Interests:Philip J Mease Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Atul Deodhar Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, UCB, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma. Director of Imaging Rheumatology BV, Frank Behrens Consultant of: Pfizer, AbbVie, Sanofi, Lilly, Novartis, Genzyme, Boehringer, Janssen, MSD, Celgene, Roche, Chugai, Bristol Myers Squibb, UCB Pharma, Grant/research support from: Pfizer, Janssen, Chugai, Celgene, Roche, Alan Kivitz Shareholder of: Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences, Inc., Novartis; Paid consultant: AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences, Inc, Speakers bureau: Amgen, Horizon, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie, Thomas Lehman Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Lan Wei Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Marleen Nys Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Subhashis Banerjee Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Miroslawa Nowak Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb
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Wijeratne, Tissa, Carmela Sales, Chanith Wijeratne, Leila Karimi, and Mihajlo Jakovljevic. "Systematic Review of Existing Stroke Guidelines: Case for a Change." BioMed Research International 2022 (June 15, 2022): 1–11. http://dx.doi.org/10.1155/2022/5514793.
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Background and Purpose. Stroke represents one of the most important causes of morbidity (Just over hundred million patients with disabling of ongoing effects of stroke at a given time, globally) and mortality (the second leading cause of death) worldwide. Innovative system biology-based approach is likely to increase the understanding of the underpinning of acute stroke promise to enhance stroke prevention, acute treatment, and neurorehabilitation. Recent growing body of evidence with shared pathobiology with COVID-19 and the critically important role of inflammation in the context of stroke points to far-reaching consequences of acute stroke, just as in the case of COVID-19 (postacute event issues as well as long term issues). So far, stroke is typically defined by late-appearing disease manifestation by the range of stroke subtypes as defined by the WHO or American Stroke Association. This definition neglects the underlying pathobiological mechanisms such as low-grade chronic inflammation and already compromised vascular system. Diseases such as stroke are hardly a simple result of a single problem but rather a complex cascade of pathobiological processes and interactions in a complex biochemical environment. The evidence of changes in innate immunity and adaptive immunity during the index event of acute stroke and recovery over next 3-12 months can be easily elicited with simple bedside blood tests such as neutrophil-lymphocyte ratio (NLR) with well over 300 published papers including several systematic reviews and meta-analyses confirming this. Global standard operating procedures (SOP) of stroke care are dictated by the national and international stroke guidelines at present. It is imperative to explore the evidence of system biology approach in current stroke guidelines. This is likely to be a key turning point in managing stroke across the continuum (prevention, management of acute event, and rehabilitation). Methods. We systematically searched for guideline recommendation on the day-to-day use of peripheral inflammatory markers such as NLR published in the English language between January 1, 2005, and October 2020. Any other evidence of system biology-based approach or recommendation was explored within the selected guidelines for this scoping review. Only the latest guideline per writing group was selected. Each guideline was analyzed independently by 2 to 4 authors to determine clinical scenarios explained/given, scientific evidence used, and recommendations presented in the context of system biology. Results. The scoping review found 2,911 titles at the beginning of the search. Final review included with 15 guidelines. Stroke-related organizations wrote sixty-five percent of the guidelines while national ministries wrote a fewer number of guidelines. We were primarily interested in recommendations for acute management in AIS published in the English language. Fifteen eligible guidelines were identified from 15 different countries/regions. None of the guidelines recommended the routine use of peripheral markers of inflammation, such as NLR, among their acute assessment and management recommendations. None of the existing guidelines explored the system biology approach to one of the most complex diseases affecting the human brain, stroke. Conclusions. This systematic review has identified a significant evidence-practice gap in all existing national stroke guidelines published in English medium as of October 2020. These guidelines included the only current “living stroke guidelines,” stroke guidelines from Australia with a real opportunity to modernize the living stroke guidelines with systems biology approach, and provide 2020 vision towards better stroke care globally. Investigation of complex disease such as stroke is best served through a systems biology approach. One of the easiest places to start is simple blood tests such as total white cell count and NLR. Systems biology approach point us towards simple tools such immune-inflammatory index (SII) and serial systemic immune inflammatory indices (SSIIi) which should pave the way for the stroke physician community address the challenges in systems biology approach in stroke care. These challenges include translating bench research to the bedside, managing big data (continuous pulse, blood pressure, sleep, oxygen saturation, progressive changes in NLR, SII, SSIIi, etc.). Working with an interdisciplinary team also provides a distinct advantage. Recent adoption of historic WHO-IGAP calls for immediate action. The 2022 World Brain Day campaign on Brain Health for All is the perfect opportunity to raise awareness and start the process.
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Amin, Alpesh N., Nicole Princic, Jay Lin, Stephen Thompson, and Stephen Johnston. "Real-World Analysis of the Duration of Risk of Venous Thromboembolism In US Surgical Patients." Blood 116, no. 21 (2010): 479. http://dx.doi.org/10.1182/blood.v116.21.479.479.
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Abstract Abstract 479 Background: Patients hospitalized for major surgery are at significant risk of developing venous thromboembolism (VTE). In the US, the length of acute hospitalization for surgery has been decreasing. Given the decreased length of hospital stays, the time during which surgical patients are at risk for VTE is not well-understood in real-world clinical practice. Such information could provide insights into whether current recommendations regarding VTE prophylaxis reflect the real world needs. This retrospective, observational study assessed the incidence and time course of VTE events following admission to the hospital for major surgery in a large, real-world patient population. Methods: This study employs administrative claims data derived from the Thomson Reuters MarketScan®Inpatient Drug Link File, which comprises longitudinal patient-level inpatient and outpatient medical and pharmaceutical claims data for individuals with employer-sponsored primary or Medicare supplemental health insurance. Patients at risk for VTE due to a hospital admission between January 1, 2005, and December 31, 2008, for either abdominal or orthopedic surgery were included in this study (obtained through charge codes for types of surgical procedures that reflect the American College of Chest Physicians guideline risk groups for VTE). Patients were included if they had been continuously enrolled for at least 12 months prior to admission and at least 180 days after admission. Additionally, patients included in the analysis were required to have received some form of pharmacological prophylaxis during their hospitalization. Appropriateness of prophylaxis was not determined. The cumulative risk and hazard of VTE were established across an evaluation period of 180 days. The distribution of cumulative risk was described by the Kaplan Meier product limit method of survival analysis. The distribution of the hazard of VTE was described by a locally weighted regression procedure. The hazard function is measured as the number of VTE events per 1,000 person-days by number of days after hospital admission date to the first occurrence of VTE. Results: The study cohort consisted of 6,445 surgical patients who received prophylaxis, of whom 3,726 (57.8%) were admitted for orthopedic surgery and 2,719 (42.2%) for abdominal surgery. Patients had a mean (standard deviation [SD]) age of 64.0 (13.6) years and 63.8% were female. The mean (SD) length of stay in hospital was 5.4 (6.1) days, during which all patients received prophylaxis for VTE (criteria for inclusion) with a mean (SD) duration of 4.7 (4.3) days. 30% of patients received anticoagulation therapy within the period extending from discharge to 35 days after discharge. A total of 243 VTE events (171 DVT and 96 PE) occurred during the 180-day evaluation period. 104 (43%) VTE events occurred during the index hospitalization, and 139 (57%) VTE events occurred post-discharge. The time course of VTE events showed that the highest number of events occurred during the first 9 days (66 events, 80% in-hospital; proportion of 180-day cumulative risk ∼22%) and during days 10–19 (55 events, 58% in-hospital; proportion of 180-day cumulative risk ∼50%) following admission for the index hospitalization. VTE hazard peaked at approximately 1.4 per 1,000 person-days on the 9th day following admission for the index hospitalization. By the 21st day following index admission 50% of the cumulative 180-day risk had been incurred. The frequency of VTE then further decreased during days 20–29 (21 events, 38% in-hospital; proportion of 180-day cumulative risk ∼58%) and gradually declined thereafter, fluctuating at a background level of 1–7 events during each 10-day interval from 70–79 days up to 170–180 days. Conclusions: Over a 180-day period after admission to the hospital 243 (3.8%) out of 6,455 at-risk surgery patients receiving pharmacological prophylaxis experienced an incident VTE event. Of these VTE events, 43% occurred during the index hospitalization, while 57% occurred post-discharge. Of all VTE events that occurred within the 180-day period, a quarter occurred within 10 days and half within 3 weeks. Results from this study show that the risk of VTE was highest within the first 19 days after admission to the index hospitalization. During this high-risk period, 30% of VTE events occurred after discharge, suggesting that a non-trivial risk of VTE extends into the period after discharge. Disclosures: Amin: sanofi-aventis US Inc.: Acknowledgment: This study was funded by sanofi-aventis U.S., Inc. The authors received editorial/writing support provided by Tessa Hartog, PhD of Excerpta Medica, in the preparation of this poster funded by sanofi-aventis U.S., Inc., Honoraria, Speakers Bureau. Princic:sanofi-aventis US Inc.: Research Funding. Lin:sanofi-aventis US Inc.: Employment, Research Funding. Thompson:sanofi-aventis US Inc.: Employment. Johnston:sanofi-aventis US Inc.: Research Funding.
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Uy, Natalie F., Edward Pequignot, Noelle V. Frey, et al. "Hypogammaglobulinemia and Infection Risk in Chronic Lymphocytic Leukemia (CLL) Patients Treated with CD19-Directed Chimeric Antigen Receptor T (CAR-T) Cells." Blood 136, Supplement 1 (2020): 30–32. http://dx.doi.org/10.1182/blood-2020-141224.
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INTRODUCTION Anti-CD19 CAR T-cell immunotherapy is promising for patients with relapsed/refractory CLL. Hypogammaglobinemia can result from normal CD19+ B-cell depletion by CAR-T cells. CLL patients are already at risk for infections due to impaired immune function, lymphodepletion prior to CAR-T cells infusion, and immunosuppressive therapies. Intravenous immunoglobulin (IVIG) is used to manage hypogammaglobulinemia, although standard criteria for IVIG administration in this setting has not been established. We studied the incidence of hypogammaglobinemia and report infectious complications, risk factors, IVIG use, and clinical outcomes for CLL patients treated with anti-CD19 CAR-T cells. METHODS Adult CLL patients who received CD19-directed CAR-T therapy in 3 clinical trials (NCT01029366, NCT01747486, NCT02640209) from July 2010 to February 2020 were included. We reviewed demographics, available IgG levels, IVIG use, and clinical outcomes with a particular focus on infectious complications. Hypogammaglobulinemia was defined as IgG &lt;4.5 g/L. Infections during the first 28 days after CAR-T were excluded to account for chemotherapy-induced neutropenia. CLL response was based on the 2008 International Workshop Group on CLL as per study protocols. The use of IVIG for hypogammaglobulinemia was at the discretion of investigator or treating physician. Fisher's test, Wilcoxon test and logrank were used for data analysis. RESULTS Records of 71 adult patients with CLL were reviewed; 4 were excluded from further analysis as they did not have IgG levels after CAR-T. The median age at time of CAR-T was 63 years (range 43-78 years). 31 patients (46%) were alive, 31 (46%) were deceased, and 5 (7%) were lost to follow up at time of review. Median follow up for all patients was 33 months (range 2-114 months). Of the 55 patients with an IgG level prior to CAR-T infusion, 24 (44%) had hypogammaglobulinemia at baseline After CAR-T infusion, 54 of 67 patients (81%) developed new or persistent hypogammaglobulinemia, and 40 of these patients (74%) received IVIG (Table 1). Forty-eight patients (72%) received at least one infusion of IVIG after CAR-T. Median time to initiation of IVIG after CAR-T infusion was 2.8 months (range 0.1-71.2 months). IVIG was used in 29 of 35 (83%) responders (defined as PR or CR) vs 19 of 32 (59%) in non-responders (defined as NR or PD) (p=0.056). There was no difference in survival observed based on whether or not patients had hypogammaglobulinemia (Figure). 42 patients (63%) had documented infections not related to chemotherapy-induced neutropenia. Fifteen (22%) had one documented infection, and 27 (40%) had more than one documented infection. There were 13 infections documented in patients who did not have hypogammaglobulinemia; the most common were ENT/sinus infections (5), bacteremia (2), URI (2), and other (2). There were 94 infections documented in patients who developed or had persistent hypogammaglobulinemia; the most common were lower respiratory tract infection/pneumonia (21), URI (20), and ENT/sinus infections (13). Complete and partial responders had more infections compared to non-responders or those who progressed (p = 0.01). Patients with hypogammaglobulinemia after CAR-T had an average of 1.74 (range 0-15) infections vs 1 (range 0-3) in patients without hypogammaglobulinemia. Patients who received IVIG had more infections (p=0.003); without IVIG the average number of infections was 0.58 (range 0-3), and with IVIG, the average number of infections was 2.00 (range 0-15). CONCLUSION Evaluating clinical outcomes with infections after CAR-T and potential strategies to minimize infection risk may improve morbidity and mortality in CLL patients. Use of IVIG was driven by individual practice, with heterogeneity regarding indication, frequency, and duration of treatment, though there was no difference in patient characteristics or response in patients who did or did not develop hypogammaglobulinemia. Patients who responded to CAR-T had more frequent infections, as might be expected in the setting of transient or persistent B- cell aplasia or hypoplasia. Patients who had more infections were more likely to receive IVIG. Further studies to define criteria for IVIG repletion in CLL patients treated with CD19-directed CAR-T cells may be incorporated in a standard clinical management algorithm. Table 1 Disclosures Frey: Amgen: Consultancy, Honoraria; Syntax: Consultancy, Honoraria; Kite Pharma: Consultancy, Honoraria. Davis:Tmunity Therapeutics, Inc.: Consultancy, Patents & Royalties, Research Funding; Cellares Corporation: Membership on an entity's Board of Directors or advisory committees; Novartis Institutes for Biomedical Research: Patents & Royalties. Hexner:Blueprint Medicines Corporation: Other: serves on a data safety monitoring committee, Research Funding; Novartis: Research Funding; Samus Therapeutics: Research Funding; American Board of Internal Medicine: Other: member of the hematology exam committee. Schuster:Novartis, Genentech, Inc./ F. Hoffmann-La Roche: Research Funding; AlloGene, AstraZeneca, BeiGene, Genentech, Inc./ F. Hoffmann-La Roche, Juno/Celgene, Loxo Oncology, Nordic Nanovector, Novartis, Tessa Therapeutics: Consultancy, Honoraria. Gill:Fate: Consultancy; Sensei: Consultancy; Aileron: Consultancy; Tmunity Therapeutics: Research Funding; Carisma Therapeutics: Patents & Royalties, Research Funding; Novartis: Research Funding. Grupp:Servier: Research Funding; Kite/Gilead: Research Funding; Roche: Consultancy; GlaxoSmithKline: Consultancy; Humanigen: Consultancy; CBMG: Consultancy; Jazz: Other: SSC; Adaptimmune: Other: SAB; TCR2: Other: SAB; Cellectis: Other; Juno/BMS: Other; Janssen/JnJ: Consultancy; CRISPR Therapeutics/Vertex Pharmaceuticals: Other; Allogene: Other; Novartis: Consultancy, Other: SSC, Research Funding. Melenhorst:Johnson & Johnson: Consultancy, Other: Speaker; Novartis: Other: Speaker, Research Funding; Kite Pharma: Research Funding; IASO Biotherapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Poseida Therapeutics: Consultancy; Simcere of America: Consultancy. Lacey:Novartis: Patents & Royalties: CAR T cells, Research Funding; Tmunity: Research Funding; Cabaletta: Research Funding; Carisma: Research Funding. Fraietta:Tmunity: Research Funding. Hwang:Novartis: Research Funding; Tmunity Therapeutics: Research Funding. Siegel:Novartis: Patents & Royalties; Tmunity: Patents & Royalties; Poseida: Membership on an entity's Board of Directors or advisory committees; Vetigenics: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees. Levine:Terumo: Consultancy; Novartis: Consultancy, Patents & Royalties: Dr. Levine has a patent Methods for treatment of cancer (US 8906682) (US 8916381)(US 9101584) with royalties paid to University of Pennsylvania, a patent Compositions for treatment of cancer (US 8911993) (US 9102761) (US 9102760) with royalties paid to U; Lilly Asia Ventures: Consultancy; Avectas: Membership on an entity's Board of Directors or advisory committees; Patheon: Membership on an entity's Board of Directors or advisory committees; Immuneel: Membership on an entity's Board of Directors or advisory committees; Incysus: Membership on an entity's Board of Directors or advisory committees; Ori Biotech: Membership on an entity's Board of Directors or advisory committees; Vycellix: Membership on an entity's Board of Directors or advisory committees; Tmunity Therapeutics: Current equity holder in private company, Research Funding. June:Bluesphere Bio: Membership on an entity's Board of Directors or advisory committees; Cabaletta Bio: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees; Carisma Therapeutics: Membership on an entity's Board of Directors or advisory committees; Cellares: Membership on an entity's Board of Directors or advisory committees; Celldex: Consultancy, Membership on an entity's Board of Directors or advisory committees; DeCART Therapeutics: Membership on an entity's Board of Directors or advisory committees; Immune Design: Membership on an entity's Board of Directors or advisory committees; Kiadis Pharma: Current equity holder in private company; Novartis: Patents & Royalties, Research Funding; Tmunity Therapeutics: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties, Research Funding; Ziopharm Oncology: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees. Porter:Tmunity: Patents & Royalties; Novartis: Honoraria, Other: Advisory board, Patents & Royalties: CAR T cells for CD19+ malignancies, Research Funding; American Board of Internal Medicine: Other: Member, exam writing committee (end date Oct 2019); National Marrow Donor Program: Membership on an entity's Board of Directors or advisory committees; Janssen: Other: Advisory board; Genentech/Roche: Current equity holder in publicly-traded company, Other: Spouse employment (ended Sept 2020); her salary includes stock/options; Glenmark: Other: Advisory board; Adicet bio: Other: Advisory board; Incyte: Other: Advisory board; Kite/Gilead: Other: Advisory board. OffLabel Disclosure: CAR T cells for CLL
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Petri, M. A., G. Bertsias, M. Daniels, et al. "POS0183 THE EFFECT OF BELIMUMAB ON SRI-4 RESPONSE IN MULTIPLE SUBGROUPS OF PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS OF A LARGE INTEGRATED ANALYSIS." Annals of the Rheumatic Diseases 81, Suppl 1 (2022): 323.1–323. http://dx.doi.org/10.1136/annrheumdis-2022-eular.1807.
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BackgroundBelimumab (BEL) is approved for the treatment of active autoantibody-positive systemic lupus erythematosus (SLE).1 Four Phase 3 studies have consistently demonstrated greater SLE Responder Index (SRI) response rates with BEL vs placebo (PBO).2-5 This robust dataset allows for additional exploration of the onset of efficacy of BEL and response rates by patient (pt) characteristics.ObjectivesTo perform a post hoc analysis evaluating the effect of BEL on SRI-4 response across a large, pooled population and pt subgroups.MethodsThe Belimumab Summary of Lupus Efficacy (Be-SLE) integrated analysis evaluated data from adults with SLE from 5 double-blind, PBO-controlled BEL trials: BLISS-76, BLISS-52, BLISS-NEA, BLISS-SC, and EMBRACE.2-6 Pts were randomised to BEL (monthly intravenous 10 mg/kg or weekly subcutaneous 200 mg) or PBO, plus standard therapy. Data were collected every 4 weeks (wks) from baseline (BL) to Wk 52. The SRI-4 response rate (a composite measure that includes ≥4-point reduction in Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index [SELENA-SLEDAI] score, stable Physician Global Assessment [PGA] increase of <0.3, and no new British Isles Lupus Assessment Group [BILAG] 1A/2B organ domain scores) by visit and time to first SRI-4 response maintained through Wk 52 were determined for both treatment groups. SRI-4 response rates at Wk 52 were evaluated by BL characteristic subgroups: SELENA-SLEDAI score; SLE International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score; disease duration; biomarker levels (anti-dsDNA, complement [C]3/C4); glucocorticoid (GC), immunosuppressant (IS), and antimalarial (AM) use.ResultsOverall, 3086 pts were included (BEL, n=1869; PBO, n=1217). Most were female (94.4%); mean (standard deviation [SD]) age was 37.0 (11.6) years. Mean (SD) SLE duration was 6.4 (6.4) years.At Wk 52, in the overall population, significantly more BEL vs PBO pts were SRI-4 responders (Figure 1). A significantly greater proportion of SRI-4 responders was observed with BEL vs PBO as early as Wk 8 (38.4% vs 33.3%; odds ratio, OR [95% confidence interval, CI] 1.25 [1.07, 1.46]; p=0.0060), which continued to increase to Wk 52 (54.8% vs 41.6%; OR [95% CI] 1.70 [1.46, 1.98]; p<0.0001). At Wk 52, more BEL vs PBO pts had a 4-point reduction in SELENA-SLEDAI (56.3% vs 43.1%; OR [95% CI] 1.71 [1.47, 2.00]; p<0.0001), no worsening in PGA (76.6% vs 67.9%; OR [95% CI] 1.52 [1.28, 1.79]; p<0.0001), and no new BILAG 1A/2B organ domain scores (77.1% vs 69.4%; OR [95% CI] 1.47 [1.25, 1.74]; p<0.0001). Pts on BEL were 52% more likely to experience an SRI-4 response that was maintained through Wk 52 (hazard ratio, HR [95% CI] 1.52 [1.36, 1.69]; p<0.0001).Figure 1.SRI-4 response at Wk 52 in the overall population and by BL characteristic subgroups.*OR (95% CI) and p-value are from a logistic regression model for BEL vs PBO comparison with covariates of treatment group, study and BL SELENA-SLEDAI score (≤9 vs ≥10)SRI-4 response rates were significantly higher with BEL vs PBO in most subgroups, with the highest response rates observed in pts with SELENA-SLEDAI score of ≥10, low C3 and/or C4 + anti-dsDNA ≥30 IU/ml, and low C3 and/or C4 at BL (Figure 1).ConclusionSignificantly more pts receiving BEL had SRI-4 response rates that occurred from Wk 8 and were maintained through Wk 52 compared with pts receiving PBO. The efficacy of BEL was consistent across multiple pt subgroups, with higher response rates in pts with SELENA-SLEDAI scores of ≥10, low C3 and/or C4 + anti-dsDNA ≥30 IU/ml and low C3 and/or C4 at BL. These results further substantiate the benefits of BEL in the treatment of adults with SLE.References[1]GlaxoSmithKline. Benlysta US prescribing information. 2021[2]Furie R, et al. Arthritis Rheumatol 2011;63(12):3918–30[3]Navarra SV, et al. Lancet 2011;377(9767):721–31[4]Stohl W, et al. Arthritis Rheum 2017;69(5):1016–27[5]Zhang F, et al. Ann Rheum Dis 2018;77(3):355–63[6] Ginzler E, et al. Arthritis Rheum 2021; doi: 10.1002/art.41900AcknowledgementsThis analysis was funded by GlaxoSmithKline (GSK). Medical writing support was provided by Lulu Hill, MPharmacol, Fishawack Indicia Ltd. UK, part of Fishawack Health, and was funded by GSK.Disclosure of InterestsMichelle A Petri Consultant of: GSK, Grant/research support from: GSK, George Bertsias Speakers bureau: Pfizer, Aenorasis, UCB, Novartis, Lilly, SOBI, Consultant of: Novartis, GSK, AstraZeneca, Grant/research support from: GSK, Pfizer, Mark Daniels Shareholder of: GSK, Employee of: GSK, Norma Lynn Fox Shareholder of: GSK, Employee of: GSK, Bevra H. Hahn Consultant of: UCB, GSK, Anne Hammer Shareholder of: GSK, Employee of: GSK, Julia Harris Shareholder of: GSK, Employee of: GSK, Holly Quasny Shareholder of: GSK, Employee of: GSK, Chiara Tani Speakers bureau: GSK, AstraZeneca, Anca Askanase Consultant of: AstraZeneca, Aurinia Pharmaceuticals Inc., Amgen, AbbVie Inc., BMS, GSK, Grant/research support from: AstraZeneca, Eli Lilly and Company, GSK, Idorsia Pharmaceuticals Ltd, Janssen Pharmaceuticals, Pfizer
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Khorana, Alok A., Jeffrey S. Berger, Philip S. Wells, et al. "Risk of Venous Thromboembolism Recurrence Among Rivaroxaban Treated Patients Who Continued Versus Discontinued Therapy: Analyses Among VTE Patients." Blood 128, no. 22 (2016): 144. http://dx.doi.org/10.1182/blood.v128.22.144.144.
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Abstract Background: The American College of Chest Physicians (ACCP) guidelines for venous thromboembolism (VTE) disease recommend treatment with anticoagulation for at least 3 months in patients with VTE. Moreover, the EINSTEIN-extension study assessed the effect of rivaroxaban on the risk of VTE recurrences in patients who had completed 6 to 12 months of treatment for VTE. Results showed that rivaroxaban significantly reduced the risk of VTE recurrences with a small increased risk of major bleeding. The objective of this study was to assess the risk of VTE recurrences and major bleeding associated with extended rivaroxaban treatment in a real-world setting among all VTE patients (i.e., unprovoked, provoked, and cancer related). Methods: A retrospective study was conducted using Truven Health Analytics MarketScan Databases from 02/2011 to 04/2015. The study included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and continuously used rivaroxaban for at least 3 months. The end of the initial 3-month rivaroxaban treatment was defined as the index date and patients were categorized into discontinued (treatment ended) and continued cohorts. Patients were followed from index date until end of continuous treatment for the continued cohort or end of data or re-initiation of oral anticoagulant therapy for the discontinued cohort. The outcomes included VTE recurrences identified as a primary diagnosis documented during a hospitalization and major bleeding events identified by a validated algorithm (Cunningham et al., 2011). Kaplan-Meier rates for VTE recurrences and major bleeding events at 3, 6, 9, and 12 months after the index date were compared between cohorts with adjustment for baseline confounding using the inverse probability of treatment weights (IPTW) method based on propensity score. Patients with unprovoked VTEs, defined as not having recent surgery, cancer, pregnancy or estrogen therapy, were also evaluated. Sample sizes of patients with provoked VTEs and cancer were too small to analyze these populations. A sensitivity analysis was also conducted among VTE patients receiving rivaroxaban for at least 6 months. Results: Among the 3-month treatment population, a total of 5,933 (63.4% unprovoked VTE) and 1,536 (68.4% unprovoked VTE) rivaroxaban users formed the continued and discontinued cohorts, respectively. The mean (SD) observation period was 149.3 (124.4) days in the continued cohort and 211.1 (191.6) days in the discontinued cohort. The Kaplan-Meier analysis (Figure 1) showed that patients in the continued cohort had significantly lower rates of VTE recurrences after an additional 3 months (0.70% vs. 1.70%), 6 months (1.41% vs. 2.34%), 9 months (1.82% vs. 3.01%), and 12 months (1.97% vs. 3.01%; all p-values < 0.05) of treatment. No statistically significant differences in the cumulative event rates for major bleeding (Figure 2) were observed between the continued and the discontinued cohort at 3 months (0.58% vs. 0.82%), 6 months (0.91% vs. 0.88%), 9 months (1.33% vs. 1.18%), and 12 months (1.44% vs. 1.44%; all p-values > 0.05). Among the 6-month treatment population, a total of 2,676 (65.9% unprovoked VTE) and 1,127 (70.4% unprovoked VTE) rivaroxaban users formed the continued and discontinued cohorts, respectively. The mean (SD) observation period was 158.5 (130.6) days in the continued cohort and 206.5 (171.5) days in the discontinued cohort. Patients in the continued cohort had lower rates of VTE recurrences after an additional 3 months (0.82% vs. 1.41%), 6 months (1.22% vs. 2.69%), 9 months (1.35% vs. 3.02%), and 12 months (1.72% vs. 3.70%; except at 3 months all p-values < 0.05) of treatment. No differences in the cumulative event rates for major bleeding were observed between the continued and the discontinued cohorts. Similar results were found among patients with unprovoked VTE for the 3- and 6-month analyses. The interaction term between the cohort variable (Continued vs. Discontinued) and the type of VTE (unprovoked vs. other types of VTE) was non-significant in both populations (p-value > 0.05), which suggests that the benefit of extended treatment do not depend on the type of VTE events. Conclusions: Our study results suggest that all patients with VTE who continued rivaroxaban therapy after the first 3-month and 6-month treatment periods had significantly lower risk of VTE recurrences without an increased risk of major bleeding. Disclosures Khorana: Halozyme: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Leo: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding. Berger:AZ: Research Funding; Merck: Membership on an entity's Board of Directors or advisory committees. Wells:BMS/Pfizer: Research Funding; Itreas: Other: Served on a Writing Committee; Janssen Pharmaceuticals: Consultancy; Bayer Healthcare: Other: Speaker Fees and Advisory Board. Seheult:Janssen Scientific Affairs, LLC: Consultancy. Ashton:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lejeune:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Wildgoose:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Kaatz:Bristol Myer Squibb: Honoraria; Pfizer: Honoraria; CSL Behring: Honoraria; Boehringer Ingelheim: Consultancy; Pfizer: Consultancy; Janssen: Consultancy; Daiichi Sankyo: Consultancy; Bristol-Myers Squibb: Consultancy; Boehringer Ingelheim: Honoraria; Janssen: Honoraria.