Sensitive educational research
Louis Cohen, Lawrence Manion, Keith Morrison in Research Methods in Education, 2017
Clearly, in some cases, it is impossible for individual people, schools and departments not to be identified, for example, schools may be highly distinctive and, therefore, identifiable (Whitty and Edwards, 1994, p. 22). In such cases clearance may need to be obtained for the disclosure of information. This is not as straightforward as it may seem. For example, a general principle of educational research is that no individuals should be harmed (non-maleficence), but what if a matter that is in the legitimate public interest is brought to light (e.g. a school’s failure to keep to proper accounting procedures)? Should the researcher follow up the matter privately, publicly or not at all? If it is followed up then certainly harm may come to the school’s officers.
Innovations in psychiatric criminology
John A. Liebert, William J. Birnes in Psychiatric Criminology, 2016
Medical clearance is medical clearance. An organic brain syndrome admitted to inpatient psychiatry as “psychosis,” for whatever reason, is not emergency psychiatry; it is very sloppy emergency medicine—all considerations of hassles and jeopardy of EMTALA aside—when med-surg beds are not readily available. When no med-surg beds are available and you believe, on a more likely than not Basis, that the patient's altered mental status is caused by medical-surgical disease, transport the patient with your stated purpose, intent, and documentation to the nearest med-surg bed appropriate for care—not to inpatient psychiatry just to avoid any risk whatsoever of EMTALA.
Condyloma
Miranda A. Farage, Howard I. Maibach in The Vulva, 2017
Excisional procedures all share the same technique of surgical removal of the condyloma and the underlying affected epidermis. The two most common techniques are the loop electro-surgical excision procedure (LEEP) and sharp (knife, scissor, shave, or curettage) excisions. The overall clearance rates range from 35% to 72%, with recurrence rates of 25%–40% (45).
Recent advances in clearance monitoring of monoclonal antibodies in patients with inflammatory bowel diseases
Published in Expert Review of Clinical Pharmacology, 2021
Wannee Kantasiripitak, Zhigang Wang, Isabel Spriet, Marc Ferrante, Erwin Dreesen
The ultimate goal of mAbs treatment in patients with IBD is to improve the patients’ quality of life, treatment outcomes, and cost-effectiveness while minimizing the risk of toxicity. TDM and MIPD have been put forward as potential tools for achieving this goal. Recently, the clearance of mAbs was suggested to serve as a blood-based marker for monitoring the IBD treatment. Therefore, the concept of clearance monitoring, next to TDM and MIPD has been speculated as a potential tool for improving IBD treatment. To date, the value of clearance monitoring has been identified in two IBD settings; (i) as a predictor for the need for colectomy during induction treatment in patients with acute severe UC [77], and (ii) as a predictor for the relapse risk in stable patients who undergo treatment de-escalation [48]. We hypothesize that clearance monitoring will be utilized for broader purposes: (i) as an indicator for the (yet undetectable) onset of immunogenicity, (ii) as a marker for (yet asymptomatic) disease activity, (iii) for dose optimization, and (iv) as a predictor for treatment outcome. However, before becoming a tool for precision medicine in the era of immunotherapy, the clinical value of clearance monitoring is awaited to be confirmed.
The Efficacy of Cognitive Videogame Training for ADHD and What FDA Clearance Means for Clinicians
Published in Evidence-Based Practice in Child and Adolescent Mental Health, 2021
Steven W. Evans, Theodore P. Beauchaine, Andrea Chronis-Tuscano, Stephen P. Becker, Anil Chacko, Richard Gallagher, Cynthia M. Hartung, Michael J. Kofler, Brandon K. Schultz, Leanne Tamm, Eric A. Youngstrom
It is also important to distinguish between “approval” and “clearance.” FDA approval indicates that benefits of a device outweigh known risks for its intended use. FDA clearance indicates that a manufacturer demonstrated that their product is substantially equivalent to a similar, legally marketed device with existing clearance or approval. The FDA grants approval to Class III devices, not to Class I or II devices. Because Class III devices are associated with significantly higher risk, approval requires premarket approval (PMA) as opposed to 510(k), and safety and efficacy must be demonstrated through clinical evidence – a more rigorous review than for Class I or II devices. Because EndeavorRXTM is a Class II device and thus poses lower risk of use, developers simply had to demonstrate that its use provided more benefits than risks. This does not translate to being an “evidence-based treatment.” Therefore, given the process outlined herein, it is understandable how EndeavorRXTM received FDA clearance without evidence of meaningful clinical benefit.
Artificial intelligence for diagnosis of mild–moderate COVID-19 using haematological markers
Published in Annals of Medicine, 2023
Krishnaraj Chadaga, Srikanth Prabhu, Vivekananda Bhat, Niranjana Sampathila, Shashikiran Umakanth, Rajagopala Chadaga
The COVID-19 and non-COVID-19 ILI patient datasets were obtained from Dr TMA Pai Hospital and Kasturba Medical College. The above hospitals are situated in the Udupi District, India. Ethical clearance was obtained to carry out this study (ethical clearance ID: IEC: 613/2021). Informed verbal consent was also taken from the patients before conducting this study. The details of patients who underwent the RT-PCR test between April 2022 and December 2022 were considered. Blood test results were obtained from 870 patients (270 non-COVID-19 ILI, 300 mild COVID-19 and 299 moderate COVID-19 patients). Severe COVID-19 patients were not considered in this study since the number of severe cases has drastically reduced after introducing COVID-19 vaccines. Further, these patients’ markers vary drastically, making the classification biased towards severe COVID-19 patients. Every patient was asymptomatic or had mild–moderate influenza symptoms such as myalgia, cough and fever. A clear description of the parameters is made in Table 1.
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