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The Unesco Courier Jul 1979
Topics: Delivery of Health Care; Health; Health Services; Medicine; Plants, Medicinal
PubMed: 12309934
DOI: No ID Found -
Clinical Pharmacology and Therapeutics Jan 2023Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been...
Real-world data/evidence (RWD/RWE) may provide insightful information on medicines' clinical effects to guide regulatory decisions. While its contribution has been recognized for safety monitoring and disease epidemiology across medicines' life cycles, using RWD/RWE to demonstrate efficacy requires further evaluation. This study aimed to (i) characterize RWD/RWE presented by applicants to support claims on medicines' efficacy within initial marketing authorization applications (MAAs) and extension of indication applications (EoIs), and (ii) analyze the contribution of RWD/RWE to regulatory decisions on medicines' benefit-risk profile. RWD/RWE was included to support efficacy in 32 MAAs and 14 EoIs submitted 2018-2019. Of these, RWD/RWE was part of the preauthorization package of 16 MAAs and 10 EoIs, and was (i) considered supporting the regulatory decision in 10 applications (five MAAs, five EoIs), (ii) considered not supporting the regulatory decision in 11 (seven MAAs, four EoIs), and (iii) not addressed at all in the evaluation of 5 applications (four MAAs, one EoI). Common limitations of submitted RWD/RWE included missing data, lack of representativeness of populations, small sample size, absence of an adequate or prespecified analysis plan, and risk of several types of bias. The suitability of RWD/RWE in a given application still requires a case-by-case analysis considering its purpose of use, implying reflection on the data source, together with its assets and limitations, study objectives and designs, and the overall data package issued. Early interactions and continuous dialogues with regulators and relevant stakeholders is key to optimize fit-for-purpose RWE generation, enabling its broader use in medicines development.
Topics: Humans; Decision Making; Europe; Government Regulation; Medicine
PubMed: 36254408
DOI: 10.1002/cpt.2766 -
South African Medical Journal =... Jul 2014
Topics: Biomedical Research; Delivery of Health Care; Evidence-Based Medicine; Humans; Knowledge Management
PubMed: 25298983
DOI: No ID Found -
The Journal of the American Osteopathic... Feb 1987
Topics: Humans; Interprofessional Relations; Osteopathic Medicine; United States
PubMed: 3558018
DOI: No ID Found -
JAMA Jun 1988
Topics: American Medical Association; Medicine; Physicians; Problem Solving; United States
PubMed: 3367493
DOI: No ID Found -
Time
Topics: Cholinergic Antagonists; Energy Intake; Female; Food Labeling; Heart Diseases; Humans; Mammography; Medicine; Sunscreening Agents
PubMed: 25671988
DOI: No ID Found -
Teaching and Learning in Medicine 2020
Topics: Humans; Learning; Medicine; Police; Racism
PubMed: 33349087
DOI: 10.1080/10401334.2020.1836461 -
Literature and Medicine 2021This essay explores Sinclair Lewis's Arrowsmith (1925) through the medical-ethical and ecological contingencies of U.S. tropical medicine during the early twentieth...
This essay explores Sinclair Lewis's Arrowsmith (1925) through the medical-ethical and ecological contingencies of U.S. tropical medicine during the early twentieth century. With an eye kept on the novel's well-known "St. Hubert " chapters, the essay queries the dangerous compromises that even the most well-intentioned medical professionals have made and can make in the name of scientific progress. The novel, I argue, organizes around and yet moves beyond the traditional outbreak narrative to unravel the various political, economic, and cultural strands of U.S. imperial medicine. The novel's platform for applied sanitary science helps me revisit famed public health campaigns, particularly those from Cuba and Panama, and draw out new ways of understanding race and place in the context of global health intervention.
Topics: Cuba; Global Health; Humans; Panama; Tropical Medicine
PubMed: 34897127
DOI: 10.1353/lm.2021.0023 -
Romanian Journal of Internal Medicine =... Jun 2019Quality of care in medicine is not necessarily proportional to quantity of care and excess is often useless or even more, potentially detrimental to our patients....
Quality of care in medicine is not necessarily proportional to quantity of care and excess is often useless or even more, potentially detrimental to our patients. Adhering to the European Federation of Internal Medicine's initiative, the Romanian Society of Internal Medicine (SRMI) launched the Choosing Wisely in Internal Medicine Campaign, aiming to cut down diagnostic procedures or therapeutics overused in our country. A Working Group was formed and from 200 published recommendations from previous international campaigns, 36 were voted as most important. These were submitted for voting to the members of the SRMI and posted on a social media platform. After the two voting rounds, the top six recommendations were established. These were: 1. Stop medicines when no further benefit is achieved or the potential harms outweigh the potential benefits for the individual patient. 2. Don't use antibiotics in patients with recent C. difficile without convincing evidence of need. 3. Don't regularly prescribe bed rest and inactivity following injury and/or illness unless there is scientific evidence that harm will result from activity. Promote early mobilization. 4. Don't initiate an antibiotic without an identified indication and a predetermined length of treatment or review date. 5. Don't prescribe opioids for treatment of chronic or acute pain for sensitive jobs such as operating motor vehicles, forklifts, cranes or other heavy equipment. 6. Transfuse red cells for anemia only if the hemoglobin concentration is less than 7 g/dL or if the patient is hemodynamically unstable or has significant cardiovascular or respiratory comorbidity. Don't transfuse more units of blood than absolutely necessary.
Topics: Adult; Female; Humans; Inappropriate Prescribing; Internal Medicine; Male; Practice Patterns, Physicians'; Romania; Societies, Medical; Unnecessary Procedures
PubMed: 30730847
DOI: 10.2478/rjim-2019-0001 -
Family Medicine Mar 2006In recent years, family medicine has encountered problems recruiting and filling its Accreditation Council for Graduate Medical Education (ACGME)-accredited residencies....
In recent years, family medicine has encountered problems recruiting and filling its Accreditation Council for Graduate Medical Education (ACGME)-accredited residencies. In addressing these reverses, one increasingly popular strategy has been to acquire American Osteopathic Association (AOA) accreditation as a way to tap into the growing number of osteopathic graduates. This stratagem is founded on assumptions that parallel-accredited postdoctoral programs are attractive to doctor of osteopathy (DO) graduates, that collaboration with sponsoring colleges of osteopathic medicine (COMs) provides direct access to osteopathic students, and that DOs can play an important role in replacing the increasing scarcity of United States medical graduates who are selecting specialty residencies. Within the past 5 years, nearly 10% of all ACGME family medicine residency programs have voluntarily obtained a second level of accreditation to also qualify as AOA-accredited family medicine residency programs. This strategy has produced mixed outcomes, as noted from the results of the osteopathic matching program. The flood of osteopathic graduates into these parallel-accredited programs has not occurred. In addition, recent AOA policy changes now require ACGME-accredited programs to make a deeper educational commitment to osteopathic postdoctoral education. The most successful ACGME/AOA-accredited programs have been those that are closely affiliated with and in near proximity of a COM and also train osteopathic students in required clerkship rotations.
Topics: Accreditation; Education, Medical, Graduate; Family Practice; Humans; Internship and Residency; Osteopathic Medicine; Workforce
PubMed: 16518739
DOI: No ID Found