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In this essay, we suggest practical ways to shift the framing of crisis standards of care toward disability justice. We elaborate on the vision statement provided in the 2010 Institute of Medicine (National Academy of Medicine) “Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations,” which emphasizes fairness; equitable processes; community and provider engagement, education, and communication; and the rule of law. We argue that interpreting these elements through disability justice entails a commitment to both distributive and recognitive justice. The disability rights movement's demand “Nothing about us, without us” requires substantive inclusion of disabled people in decision‐making related to their interests, including in crisis planning before, during, and after a pandemic like Covid‐19.

During the Covid-19 pandemic, as resources dwindled, clinicians, health care institutions, and policymakers have expressed concern about potential legal liability for following crisis standards of care (CSC) plans. Although there is no robust empirical research to demonstrate that liability protections actually influence physician behavior, we argue that limited liability protections for health care professionals who follow established CSC plans may instead be justified by reliance on the principle of reciprocity. Expecting physicians to do something they know will harm their patients causes moral distress and suffering that may leave lasting scars. Limited liability shields are both appropriate and proportionate to the risk physicians are being asked to take in such circumstances. Under certain narrow circumstances, it remains unclear that the standard of care is sufficiently flexible to protect physicians from liability. Given this uncertainty, the likelihood that physicians would be sued for such an act, and their desire for such immunity, this limited protection is morally legitimate.

The new American Law Institute Medical Malpractice Restatement posits a novel rule in § 6(b) that would authorize the use of medical-practice guidelines as a standard of care for medical-malpractice litigation. However, it would only be a “safe harbor” shield; guidelines could not be similarly used by plaintiffs as a sword. For defendants, the rule would transform what heretofore has been indisputably hearsay evidence into prima facie proof that would serve as a substitute for expert testimony, and which would be sufficient to defeat a malpractice claim. Plaintiffs wishing to use practice guidelines would be relegated to the “learned treatise” exception of the hearsay rule.

Our study investigated how the standard of surgical care is assessed within the English and Welsh litigation process. The 'shadowline' represents the dividing line between acceptable and unacceptable standards of care. Our hypothesis was that different assessors risk adopting materially different interpretations regarding the acceptable standard of care. Any variation in the interpretation of where the shadowline falls will create uncertainty and unfairness to surgeons and patients alike. We summarised the legal literature and suggested the factors affecting the assessment of surgical standards. We illustrated our findings on distribution curves. There was a risk that the shape of the curve and the location of the shadowline may vary according to the assessor. Importantly, a gap may have developed between the legal and clinical shadowlines in respect of the consenting process. We suggested how a gap between the surgical and legal shadow lines could be narrowed. Clinical governance, balanced literature and realistic expert assessments were all part of the solution.

Clinical whole-exome and whole-genome sequencing will result in a broad range of incidental findings, but clinicians’ obligations to identify and disclose such findings are a matter of debate. We sought legal cases that could offer insights into clinicians’ legal liability. We searched for cases in which incidental findings were related to the cause of action, using the search engines WestLaw, WestLaw Next, Lexis, and Lexis Advance. We found no case law related to incidental findings from genetic testing but identified eight cases involving incidental findings in medical imaging. These cases suggest that clinicians may face liability for failing to disclose incidental findings that would have offered an opportunity for interventions to improve health outcome, if under the applicable standard of care, they fail to identify or appreciate the significance of the incidental finding or they negligently fail to notify other clinicians and/or the patient of the identified incidental finding. Other cases support liability for failure to refer appropriately to a clinician with greater expertise. Clinicians may face liability if they fail to disclose incidental information that could inform interventions to improve health outcome; information lacking clinical actionability is likely to have less import. Genet Med 2013:15(8):624–629

The use of the locality rule to define or modify the medical standard of care is inconsistent with modern medicine. Nevertheless, various states in the U.S. continue to adhere to a locality rule. This paper revisits this topic, about which I have previously written, by focusing on Idaho, Nebraska, Tennessee and Arkansas. The paper concludes by suggesting that locality rules should be eliminated in favor of a national standard of care.

Over 170 million individuals are chronically infected with HCV. The current standard of care for these patients is 24–48 weeks of PEG-IFN-α and ribavirin; however, many patients do not respond to this treatment. This article summarizes the findings from phase III clinical trials on the introduction of telaprevir and boceprevir to this standard therapy. The introduction of direct acting antiviral agents (DAAs) will markedly change treatment options for individuals who have a chronic HCV infection. Within the next few months, licensing of two HCV protease inhibitors (boceprevir and telaprevir) for the treatment of patients with chronic hepatitis C as part of a triple therapy with PEG-IFN-α and ribavirin is anticipated in the USA, Europe and many other countries. Final results of pivotal phase III clinical trials in previously untreated and treatment-experienced patients with HCV genotype 1 infection were presented at the Annual Meeting of the American Association for the Study of the Liver 2010 held in Boston, MA, USA, and at the Annual Conference of the Asian Pacific Association for the Study of the Liver 2011, held in Bangkok, Thailand. This article summarizes the results of these phase III trials in consideration of accumulating data on important baseline and on-treatment predictive factors for treatment response, such as the host IL28B genotype and the rapid virologic response; the introduction of these new therapies into clinical practice is also covered. Furthermore, preliminary data on the combination of different classes of DAAs, such as HCV protease inhibitors and HCV polymerase inhibitors, without interferon α are discussed. Key Points Among host and viral factors associated with sustained virologic response, the IL28B genotype and rapid virologic response (RVR) have the strongest predictive value; RVR is crucial to response-guided therapy Response-guided therapy aims to shorten treatment regimens in previously untreated patients; ∼44% and 57–65% of patients treated with boceprevir and telaprevir, respectively, qualified for shortened treatment Patients with HCV genotype 1 infection and previous treatment failure benefit from triple therapies containing boceprevir or telaprevir, but most require an extended total treatment duration (up to 48 weeks) The selection of HCV variants that have decreased susceptibility to direct acting antiviral agents might occur during treatment and is associated with virologic breakthrough and treatment failure When administering combination therapy, careful monitoring of viral load and stringent futility rules should be used to prevent the development of multiresistant HCV strains

Background Whiplash injury affects 83% of persons in a traffic collision and leads to whiplash-associated disorders (WAD). A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence. Our objective is to compare the cost-effectiveness of: 1) physician-based education and activation, 2) a rehabilitation program developed by Aviva Canada (a group of property and casualty insurance providers), and 3) the legislated standard of care in the Canadian province of Ontario: the Pre-approved Framework Guideline for Whiplash developed by the Financial Services Commission of Ontario. Methods/Design The economic evaluation will use participant-level data from the University Health Network Whiplash Intervention Trial and will be conducted from the societal perspective over the trial's one-year follow-up. Resource use (costs) will include all health care goods and services, and benefits provided during the trial's 1-year follow-up. The primary health effect will be the quality-adjusted life year. We will identify the most cost-effective intervention using the incremental cost-effectiveness ratio and incremental net-benefit. Confidence ellipses and cost-effectiveness acceptability curves will represent uncertainty around these statistics, respectively. A budget impact analysis will assess the total annual impact of replacing the current legislated standard of care with each of the other interventions. An expected value of perfect information will determine the maximum research expenditure Canadian society should be willing to pay for, and inform priority setting in, research of WAD management. Discussion Results will provide health care decision makers with much needed economic evidence on common interventions for acute whiplash management. Trial Registration http://ClinicalTrials.gov identifier NCT00546806 [Trial registry date: October 18, 2007; Date first patient was randomized: February 27, 2008]

In the U.S. Court of Appeals for the First Circuit adopted The World Professional Association of Transgender Health Standards of Care (WPATH SOC) as medical consensus on gender affirming care and held that Michelle Kosilek could access gender affirming care but that she did not meet the criteria for gender affirming surgery. In the U.S. Court of Appeals for the Fifth Circuit with a sparse record and no expert testimony denied Vanessa Lynn Gibson access to gender affirming surgery and incorrectly claimed that Kosilek did not support the WPATH SOC as representing the medical consensus on gender affirming care. Finally, the U.S. Court of Appeals for the Ninth Circuit held in that denying access to gender affirming surgery to an incarcerated transgender person suffering from severe gender dysphoria resulting in two attempts at self-castration, cutting to reduce genital distress, and suicidal ideation violated the Eighth Amendment. In doing so, the Ninth Circuit joined medical and scientific organizations who widely adopt The World Professional Association of Transgender Health Standards of Care (WPATH SOC) as medical consensus on gender affirming care. Nonetheless, 10 Ninth Circuit Judges dissented to the denial of rehearing . Although the Supreme Court denied certiorari (with Justice Thomas and Alito dissenting), the Supreme Court also denied certiorari in the Fifth Circuit case which denied access to gender affirming surgery and rejected the WPATH SOC without offering any alternatives. Transgender women are disproportionately incarcerated in the United States. Black transgender women are disproportionately represented even among incarcerated transgender women. The combination of transphobia and racism result in worse medical outcomes following a failure to provide adequate medical care. This article argues that rejecting the WPATH SOC disproportionately impacts Black transgender women. Failure to recognize the WPATH SOC as medical consensus will perpetuate medical and carceral racism and transphobia.

In 2009 the novel influenza strain H1N1 (a.k.a. swine flu) raged across the globe presenting unknown risks to populations.1 Initial public concerns were heightened by early reports of potential untimely casualties and long-term morbidity. Fortunately these fears did not fully materialize. Yet, the oft-repeated specter of rapid global migration of viral, infectious diseases like H1N1, West Nile,2 Ebola,3 Zika,4 and COVID have cumulatively generated crises mentalities among health care workers (HCWs) and within health care systems. Substantial national and regional preparedness activities since 9/11 exposed additional vulnerabilities to public health catastrophes. High on the list of concerns was a recognized lack of affirmative, consistent standards of care to employ in emergencies.5 In a true crisis, HCWs and entities would essentially have to “wing it” in regards to allocating scarce resources and providing critical treatment. In response, the Department of Health and Human Services, Assistant Secretary for Preparedness and Response (ASPR) requested the Institute of Medicine (now part of the National Academies of Science, Engineering and Medicine (NASEM)) to promulgate initial guidance on standards of care to use in public health crises.6As a member of the original NASEM committee, our essential goal was not to espouse definitive standards of care for HCWs to deploy. Rather, we sought to provide guiding principles and templates for public and private sectors to consider in planning for large scale, emergency events.7 The committee dispatched prior terminology focused on “altered standards of care.”8 A new term, “crisis standard of care” (CSC), was framed and defined generally as a “substantial change in usual health-care operations and the level of care …resulting from a pervasive or catastrophic disaster.”9Since its inception, most states and many localities are generating an array of CSC plans with federal or other financial support.10 American hospitals and other providers implement CSC following natural disasters, emerging infectious diseases, and mass casualty events (MCEs).11 Consequently, they face a slate of legal and policy issues (e.g., emergency declarations, access, allocations, liability risks/protections, authority, licensure, scope of practice, reimbursements, disabled/special needs populations) chronicled previously by NASEM's committee.12 Absent resolution (often in real-time), these issues can stymie CSC implementation when time is of the essence. Lives may be lost and injuries suffered unnecessarily due solely to law or policy barriers during crises like COVID.