The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients

2006 ◽  
Vol 3 (2) ◽  
pp. 154-157 ◽  
Author(s):  
1992 ◽  
Vol 3 (suppl b) ◽  
pp. 3-10
Author(s):  
Geogrio Zanetti ◽  
Michel P Glauser ◽  
Jean-Daniel Baumgartner

The study of standard intravenous immunoglobulin G (IVIG) preparations as adjunctive therapy in seriously ill patients is motivated by the possible need to: restore immunoglobulin G levels depleted after trauma or surgery; and/or to provide patients with specific antibodies directed against various microorganisms. Whereas no therapeutic efficacy has been shown in clinical studies with standard IVIG, some data suggest a benefit in prophylactic use. Antisera or IVIG hyperimmune against the biologically active. highly conserved core portion of the endotoxin of Gram-negative bacteria have demonstrated variable degrees of protection in animal models and clinical trials. Two clinical trials using monoclonal antibodies against core lipopolysaccharide have been completed. Only subsets of patients with the Gram-negative sepsis syndrome were protected, but both studies gave discrepant results concerning the type of patients that were reported to benefit from administration of these antibodies. Further studies will be necessary to establish whether application of this therapy can be recommended.


2020 ◽  
pp. 15-18
Author(s):  
Nina Tishchenko

The article reflects the importance and importance of the work of nurses of the Department of Palliative Care for Oncological Patients of the State Budget Health Establishment «Samara Regional Clinical Oncological Clinic». Important stages and features of care when dealing with seriously ill patients.


2021 ◽  
pp. 108482232199038
Author(s):  
Elizabeth Plummer ◽  
William F. Wempe

Beginning January 1, 2020, Medicare’s Patient-Driven Groupings Model (PDGM) eliminated therapy as a direct determinant of Home Health Agencies’ (HHAs’) reimbursements. Instead, PDGM advances Medicare’s shift toward value-based payment models by directly linking HHAs’ reimbursements to patients’ medical conditions. We use 3 publicly-available datasets and ordered logistic regression to examine the associations between HHAs’ pre-PDGM provision of therapy and their other agency, patient, and quality characteristics. Our study therefore provides evidence on PDGM’s likely effects on HHA reimbursements assuming current patient populations and service levels do not change. We find that PDGM will likely increase payments to rural and facility-based HHAs, as well as HHAs serving greater proportions of non-white, dual-eligible, and seriously ill patients. Payments will also increase for HHAs scoring higher on quality surveys, but decrease for HHAs with higher outcome and process quality scores. We also use ordinary least squares regression to examine residual variation in HHAs’ expected reimbursement changes under PDGM, after accounting for any expected changes related to their pre-PDGM levels of therapy provision. We find that larger and rural HHAs will likely experience residual payment increases under PDGM, as will HHAs with greater numbers of seriously ill, younger, and non-white patients. HHAs with higher process quality, but lower outcome quality, will similarly benefit from PDGM. Understanding how PDGM affects HHAs is crucial as policymakers seek ways to increase equitable access to safe and affordable non-facility-provided healthcare that provides appropriate levels of therapy, nursing, and other care.


2021 ◽  
pp. 096973302098339
Author(s):  
Kathy Le ◽  
Jenny Lee ◽  
Sameer Desai ◽  
Anita Ho ◽  
Holly van Heukelom

Background: Serious Illness Conversations aim to discuss patient goals. However, on acute medicine units, seriously ill patients may undergo distressing interventions until death. Objectives: To investigate the feasibility of using the Surprise Question, “Would you be surprised if this patient died within the next year?” to identify patients who would benefit from early Serious Illness Conversations and study any changes in the interdisciplinary team’s beliefs, confidence, and engagement as a result of asking the Surprise Question. Design: A prospective cohort pilot study with two Plan-Do-Study-Act cycles. Participants/context: Fifty-eight healthcare professionals working on Acute Medicine Units participated in pre- and post-intervention questionnaires. The intervention involved asking participants the Surprise Question for each patient. Patient charts were reviewed for Serious Illness Conversation documentation. Ethical considerations: Ethical approval was granted by the institutions involved. Findings: Equivocal overall changes in the beliefs, confidence, and engagement of healthcare professionals were observed. Six out of 23 patients were indicated as needing a Serious Illness Conversation; chart review provided some evidence that these patients had more Serious Illness Conversation documentation compared with the 17 patients not flagged for a Serious Illness Conversation. Issues were identified in equating the Surprise Question to a Serious Illness Conversation. Discussion: Appropriate support for seriously ill patients is both a nursing professional and ethical duty. Flagging patients for conversations may act as a filtering process, allowing healthcare professionals to focus on conversations with patients who need them most. There are ethical and practical issues as to what constitutes a “serious illness” and if answering “no” to the Surprise Question always equates to a conversation. Conclusion: The barriers of time constraints and lack of training call for institutional change in order to prioritise the moral obligation of Serious Illness Conversations.


Resuscitation ◽  
1996 ◽  
Vol 33 (1) ◽  
pp. 87 ◽  
Author(s):  
RS Phillips ◽  
NS Wenger ◽  
J Teno ◽  
RK Oye ◽  
S Youngner ◽  
...  

2021 ◽  
Vol 30 (4) ◽  
pp. 256-265
Author(s):  
Mary Beth Happ

Communication is the essence of the nurse-patient relationship. The critical care nurse’s role in facilitating patient communication and enabling communication between patients and their families has never been more important or poignant than during the COVID-19 pandemic. We have witnessed tremendous examples of resourceful, caring nurses serving as the primary communication partner and support for isolated seriously ill patients during this pandemic. However, evidence-based tools and techniques for assisting awake, communication-impaired, seriously ill patients to communicate are not yet systematically applied across all settings. Missed communication or misinterpretation of patients’ messages induces panic and fear in patients receiving mechanical ventilation and can have serious deleterious consequences. This lecture presents a 23-year program of research in developing and testing combination interventions (eg, training, tailored assessment, and tools) for best practice in facilitating patient communication during critical illness. Evidence from related nursing and inter pro fessional research is also included. Guidance for unit-based assessment, tailoring, and implementation of evidence-based patient communication protocols also is provided.


2012 ◽  
Vol 61 (1) ◽  
Author(s):  
José Luis Pérez Requejo ◽  
Justo Aznar Lucea

Mai prima d’ora i pazienti gravemente malati o con malattie incurabili o croniche, sono stati così esposti a organizzazioni mediche senza scrupoli, che approfittando del loro logico disagio e della loro preoccupazione promettono cure miracolose e trattamenti, facendo pagare enormi somme di denaro per procedure senza alcuna garanzia, alcun reale beneficio e, peggio ancora, con gravi rischi per la salute. Questo articolo discute alcuni casi di pazienti che hanno pagato con la loro salute, spesso irrimediabilmente, o in maniera catastrofica, gli effetti di terapie teoricamente avanzate con cellule staminali di alcuni centri. Ci si è riferiti a diversi paesi che, in tempi anche non remoti, offrono e praticano qualcuno di questi trattamenti, il più delle volte attraverso strategie di marketing dirette e aggressive per i pazienti o le loro famiglie, mostrando reale o fittizi rapporti relativi ad altri pazienti, ma senza previ studi scientifici che avvalorino i risultati dei presunti benefici. In questo articolo, discutiamo alcuni utili suggerimenti e linee guida internazionali per riconoscerli ed evitarli. Inoltre, abbiamo discusso in dettaglio le ragioni specifiche per cui la maggior parte dei medici e clinici sollevino dei dubbi sulla competenza e le ragioni etiche di questi centri e scoraggino i viaggi di questo “turismo medico”. È sempre consigliabile chiedere il consiglio del medico di famiglia o specialista, prima della decisione dei pazienti di ricevere trattamenti dubbi, con la certezza che il paziente avrà sempre la sua comprensione e il supporto emotivo e medico. ---------- Never before seriously ill patients with chronic or incurable diseases have been so exposed to unscrupulous medical organizations that, taking advantage of their logical distress and worry, promise miracle cures and treatments and charge them huge amounts of money for procedures with no guarantee, no real benefits and, even worse, with serious risks to their health. This paper discusses some cases of patients who paid with their health, often irreparably, or catastrophically, the effects of supposedly advanced therapy centers with stem cells. Several countries are mentioned, not always as remote, which offer and practice any of these treatments, most often by direct and aggressive marketing to patients or their families, showing real or fictional accounts of other patients, but without the previous studies and scientific papers that endorse their supposed beneficial results. In this article we discuss some useful hints and international guidelines to recognize and avoid them. Also, we discussed in detail the specific reasons why most doctors and clinics doubt about the competence and ethical reasons of these centers and discourage those “medical tourism” trips. It is always advisable to seek the advice of the family doctor or specialist in charge, before the patients decision to receive dubious treatments, with the assurance that, decide what the patient decide, they will have always his understanding and his emotional and medical support.


2017 ◽  
Vol 53 (2) ◽  
pp. 308-309 ◽  
Author(s):  
Justin Sanders ◽  
Joshua Lakin ◽  
Rachelle Bernacki ◽  
Catherine Arnold ◽  
Joanna Paladino

2020 ◽  
Vol 21 (21) ◽  
pp. 8390
Author(s):  
Antonio Martinez-Lopez ◽  
Trinidad Montero-Vilchez ◽  
Álvaro Sierra-Sánchez ◽  
Alejandro Molina-Leyva ◽  
Salvador Arias-Santiago

Alopecia is a challenging condition for both physicians and patients. Several topical, intralesional, oral, and surgical treatments have been developed in recent decades, but some of those therapies only provide partial improvement. Advanced medical therapies are medical products based on genes, cells, and/or tissue engineering products that have properties in regenerating, repairing, or replacing human tissue. In recent years, numerous applications have been described for advanced medical therapies. With this background, those therapies may have a role in the treatment of various types of alopecia such as alopecia areata and androgenic alopecia. The aim of this review is to provide dermatologists an overview of the different advanced medical therapies that have been applied in the treatment of alopecia, by reviewing clinical and basic research studies as well as ongoing clinical trials.


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