The VACCINES Act: Deciphering Vaccine Hesitancy in the Time of COVID-19.

Since the COVID-19 pandemic first hit Wuhan, China, in December 2019, scientists have been racing to develop and test novel vaccines to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The speed of scientific discovery related to COVID-19 is unprecedented. With several vaccine candidates already being tested in clinical trials, we pose the question: what will the vaccine hesitant do in the face of this pandemic?

Medical radiological procedures: which information would be chosen for the report?

AIMS AND OBJECTIVES: The aim of this study was to properly define the information regarding patient exposure to Ionizing Radiations in the radiological report, according to the European Directive 2013/59/EURATOM (EU 2013/59 art.58(b)). For this purpose, we evaluated the results from other Member States EU 2013/59 transpositions and from Guidelines recommendation published by International Organizations involved in diagnostic radiology. A practical way for implementing art.58 is also traced. MATERIALS AND METHODS: Dosimetric quantities, such as exposure, absorbed dose and effective dose which may be included in radiological report, were first analyzed; then, in order to define international state of art of Member States EU 2013/59 transposition, a Web research using French, English, Spanish and German key words was performed. RESULTS: EU 2013/59 transposition for 5 Member States was reported. Especially regarding art.58, a European project reports that few European countries (11 of 28) have identified the dose metrics to be used in radiological report. Scientific organizations supporting clinical radiologists and medical physicists have published Guidelines reporting parameters useful to quantify the radiation output and to assess patient dose. CONCLUSIONS: Our research revealed that there is not a shared interpretation of patient exposure information to be included in radiological report. Nevertheless, according to scientific community, authors believe that the exposure is the most appropriate information that could be included in radiological report. Alternatively, but with more expensiveness, a risk index based on effective dose could be used. Moreover, the systematic exposure information recorded could be useful for dose estimates of population from medical exposure.

A Menu to Evaluate Factors Influencing Implementation of Obesity Prevention Early Care and Education Regulations.

CONTEXT: In recent years, several states have adopted new regulations concerning nutrition, physical activity, and screen time in early care and education (ECE) settings to help prevent childhood obesity. OBJECTIVE: To disseminate a menu of factors that facilitate and/or impede implementation of obesity prevention regulations in ECE settings. DESIGN: To create the menu, we condensed and categorized factors identified in the literature and through field work by placing them within domains. We applied the menu by conducting semistructured interviews during a pilot test assessing implementation of ECE regulations in Colorado. SETTING AND PARTICIPANTS: We first interviewed state and local government agency leaders responsible for policy oversight, and state employees and contractors who acted as intermediaries to direct implementers. We then interviewed directors at ECE centers in the Denver, Colorado, area. We selected 21 ECE centers for a site visit on the basis of feasibility, percentage of low-income families, and diversity in race and ethnicity at each center. Seven centers participated. MAIN OUTCOME MEASURES: Minor and major facilitators and impediments to implementation of childhood obesity prevention regulations in ECE settings. RESULTS: The resulting menu includes 7 domains and 39 factors influential for implementation of ECE regulations. Of these 39 factors, interviewees identified 7 facilitating factors (4 major and 3 minor) and 2 impeding factors (both major). Major facilitating factors were buy-in from parents/caregivers, training and communication provided by governing authority and their contractors, and low level of change required by the regulations themselves. Major impeding factors were timing of implementation and balancing the demands of the regulations against other priorities. CONCLUSIONS: The menu developed by our research team, combined with existing frameworks in dissemination and implementation research, can be used by researchers, practitioners, and policy makers to anticipate factors that facilitate and/or impede implementation of ECE policies to prevent childhood obesity.

Medical abortion reversal: science and politics meet.

Medical abortion is a safe, effective, and acceptable option for patients seeking an early nonsurgical abortion. In 2014, medical abortion accounted for nearly one third (31%) of all abortions performed in the United States. State-level attempts to restrict reproductive and sexual health have recently included bills that require physicians to inform women that a medical abortion is reversible. In this commentary, we will review the history, current evidence-based regimen, and regulation of medical abortion. We will then examine current proposed and existing abortion reversal legislation. The objective of this commentary is to ensure physicians are armed with rigorous evidence to inform patients, communities, and policy makers about the safety of medical abortion. Furthermore, given the current paucity of evidence for medical abortion reversal, physicians and policy makers can dispel bad science and misinformation and advocate against medical abortion reversal legislation.

Variables That Impact Medical Malpractice Claims Involving Plastic Surgeons in the United States.

BACKGROUND: Medical malpractice lawsuits contribute directly and indirectly to the cost of healthcare in the United States. Reducing medical malpractice claims represents an often unrecognized opportunity for improving both the quality and affordability of healthcare. OBJECTIVES: The aim of this study was to better understand variables of the informed consent process that may contribute to reducing malpractice claims in plastic surgery. METHODS: A prospective multiple choice questionnaire was distributed via email to all of the 1694 members of the American Society for Aesthetic Plastic Surgery (ASAPS) to evaluate attitudes and practices of informed consent in relation to medical malpractice. RESULTS: A total of 129 questionnaires obtained from plastic surgeons were eligible for analysis (response rate 7.6%). Respondents who provided procedure-specific brochures to their patients were significantly less likely to be sued for medical malpractice (P = 0.004) than those who did not. Plastic surgeons that participated in malpractice carrier-required courses on avoiding medical malpractice litigation had a similarly significantly reduced likelihood of lawsuits. (P = 0.04). CONCLUSIONS: Variables that may reduce malpractice claims, and thereby both improve the quality and affordability of healthcare, include: (1) the use of procedure-specific patient education brochures; and (2) physician participation in malpractice insurance carrier-required courses. These findings should be of interest to physicians, hospitals, and insurance companies.

Correct information to patients undergoing breast-conserving surgery: the medicolegal significance.

Many of the women newly diagnosed with breast cancer not have access to all the information they need to make the surgical and treatment choices that are most appropriate for them. Research clearly shows that lumpectomy and other breast-conserving surgeries are just as safe as mastectomy for most women with early stage disease, and yet approximately half will undergo the more disfiguring procedures, but many healthy women who have strong family histories of breast cancer consider prophylactic mastectomies, and their decisions are also based on very limited information, because there are few studies showing the effectiveness of that procedure. This paper delineates how to avoid limited information and biased recommendations is important for a conscious and informed choice by the patients.

Supplemental Nutrition Assistance Program: Nutrition Education and Obesity Prevention Grant Program. Final rule.

This rule adopts the interim rule implementing the Supplemental Nutrition Assistance Program (SNAP) nutrition education and obesity prevention grant program with changes as provided in this rule. This rule also amends SNAP regulations to implement section 28 of the Food and Nutrition Act (FNA) of 2008, as added by section 241 of the Healthy, Hunger-Free Kids Act (HHFKA) of 2010, to award grants to States for provision of nutrition education and obesity prevention programs. These programs provide services for eligible individuals that promote healthy food choices consistent with the current Dietary Guidelines for Americans (DGAs). The rule provides State agencies with requirements for implementing section 28, including the grant award process and describes the process for allocating the Federal grant funding for each State's approved SNAP-Ed plan authorized under the FNA to carry out nutrition education and obesity prevention services each fiscal year. This final rule also implements section 4028 of the Agricultural Act of 2014 (Farm Bill of 2014), which authorizes physical activity promotion in addition to promotion of healthy food choices as part of this nutrition education and obesity prevention program.

[Frequency-specific analysis of the hVOR Prior of Cochlear Implant Operation]. / Frequenzspezifische Untersuchung des hVOR im Vorfeld einer CI-Operation.

Dizziness is one of the most common postoperative complications after a cochlear-implant (CI) surgery. With our prospective, matched-paired controlled study, we could demonstrate that patients with distinctive sensorineural hearing loss--even without any complaints of dizziness--already have a reduced horizontal vestibular-ocular-reflex (hVOR). Compared to controls, CI patients presented with a significantly reduced gain. 9 out of 17 CI patients showed physiological results in rotatory testing and video head thrust testing. One patient presented with pathological results in both tests. Remarkably, there were 2 patients who presented with pathological head impulse testing but normal values in rotatory testing and 5 patients who showed normal gains in video head impulse testing but abnormal rotatory tests. These findings clearly show the importance of a differentiated, frequency-dependent pre-operative vestibular assessment including rotatory testing and video-head impulse testing. Additionally, only an accurate pre-operative vestibular testing allows evaluating possible post-operative dizziness related complications and should be documented precisely, also for forensic reasons. This is the key to differentiate post-operative dizziness from an pre-operatively existing vestibular disorder that possibly might not be clinically apparent by the time of testing.

[Patient autonomy and informed consent - ethical and legal issues]. / Patientenautonomie und Aufklärung - Ethische und rechtliche Aspekte der Aufklärung.

Informing patients about the benefits and risks of and alternatives to proposed medical or surgical procedures is crucial to the patient-physician relationship. It is a legal and ethical precondition to a patient's informed consent to a course of action. Particularly in cases of serious illness and when there are far reaching implications for a patient's lifestyle, this process entails much more than just imparting information. Indeed, it is a dialogue through which the physician empowers the patient to reach a decision which reflects the patient's life situation and system of values. This process promotes patient autonomy. Studies have shown that this approach builds trust, increases patient satisfaction with health care and results in a higher degree of professional fulfilment for the physician.

[Informed consent analysis and its role in modern medicine]. / Analýza informovaného konsenzu a jeho role v moderní medicíne.

"Informed consent" is a term adopted by the contemporary medicine in all its fields. There may seem that it is a plain rendering of information to the patient followed by her/his decision about further procedures but the facts are different. Actually this relationship between patient and doctor has an intricate nature. It guarantees an ethical frame and structure of any treatment afforded to the patient and it covers all the possible dilemmas as conflicts of any two principles taken from any contemporary medical code while it allows no simple resolution. Individual steps require a compromise based on continuous discussion between both sides. In this process means controlled by the doctor and patients goals must be conscientiously distinguished since a goal or meaning of live is not an expertise of the doctor and the doctor is obliged solely to revere them whereas to develop means or tools (organon) in all its manners is on the other side her/his main task.

[Patients' rights--doctors' duties]. / Patientenrechte--Arztpflichten (I).

On 26 February 2013 the new "Law on Patients' Rights" (hereinafter also the "Law") became effective. This Law strengthens patients' rights vis-à-vis the insurdnce company and also regulates patients' rights regarding their relation to the doctor. This has consequences for the laws on medical liability all doctors must consider. The doctor's performance is and remains a service and such service does not hold any guarantee of success. Nevertheless, this Law primarily reads as a "law on the duties of physicians". To duly take into account these duties and to avoid mistakes and misinterpretation of the Law, the Ethics Committee of the Consortium of Osteosynthesis Trauma Germany (AOTRAUMA-D) has drafted comments on the Law. Brief summaries of its effects are to be found at the end of the respective comment under the heading "Consequences for Practice". The text of the law was influenced particularly by case law, as continuously developed by the German Federal Court of Justice ("BGH"). The implementation of the Law on Patients' Rights was effected by the newly inserted sections 630a to 630h of the German Civil Code (the "BGB"), which are analysed below. The following comments are addressed to physicians only and do not deal with the specific requirements and particularities of the other medical professions such as physiotherapy, midwifery and others so on. Special attention should be paid to the comments on the newly inserted Duty to inform, which has to be fullfilled prior to any diagnostic or therapeutic procedure (sec. 630c para 2 sentence 1 BGB). Under certain conditions the doctor also has to inform the patient about the circumstances that lead to the presumed occurance of a therapeutic or diagnostic malpractice (sec. 630c para. 2 sentence 2 BGB), based on the manifestation of an undesired event or an undesired outcome. As before, the patient's valid consent to any procedure (sec. 630d BGB) is directly linked to the comprehensive and timely provision of information (sec. 630e BGB). Comprehensive documentation obligations regarding all procedures are stipulated in sec. 630f BGB. As before, the burden of proof still rests with the patient, unless a severe malpractice has been established (sec. 630h BGB). The definition of "severe malpractice" remains unchanged and is based on the case law of the Federal Court of Justice (BGH). The patient's obligations to preserve his or her health and to actively support the process of recovery and securing a positive outcome of the treatment are not explicitly mentioned in the Law. Nevertheless, the patient and the physician need to work closely together to achieve a successful result of the treatment. In case the patient does not give his or her cooperation, the physician should consider terminating the treatment relationship.

Medical malpractice in hand surgery.

The rise in medical malpractice claims over the past few decades has altered physicians' practice patterns and has had a considerable financial impact on the medical community as a whole. While numerous studies have analyzed the content and effect of these claims, only a handful of articles have addressed specifically the issue of medical malpractice in hand surgery. This article outlines the available literature on malpractice in hand surgery, offers guidance to hand surgeons on managing medical malpractice claims, and discusses preventative measures they might take to limit such claims from being filed in the future. We conclude that the key measures one can take to protecting oneself legally are knowing and abiding by the standard of care, keeping patients informed and developing good relationships with them, and meticulously documenting. Although some malpractice claims are unavoidable, we believe that one can limit his or her exposure to them by incorporating these measures into their respective practices.

[Legal aspects of spondylosis]. / Rechtliche Gesichtspunkte bei einer Spondylodese.

Prior to a medical intervention (and also when omitted) it is important to implement the prerequisites for medical treatment as formulated by the legislation during the last decades. Essential points are the timely and comprehensive clarification and informed consent of the patient on diagnosis, therapy, complications and aftercare. The case described here substantiates the essential points which must be considered with respect to operative activities in the interests of the patient as well as the treating physicians. This problematic and the legal assessment based on expert testimony can be paradigmatically demonstrated by a verdict of the Higher Regional Court (Oberlandesgericht, OLG) Munich in association with a case of spondylosis and show why the essential points of this verdict should be discussed.

[The Patient Rights Act (PatRG)--Part 3: Burden of proof in liability questions and critical resumé]. / Das Patientenrechtegesetz (PatRG)--Teil 3: Beweislast in Haftungsfragen und kritisches Fazit.

The article deals with the new regulations in the German Civil Code (Bürgerliches Gesetzbuch - BGB), which came into effect in Germany as the Patient Rights Act (PatRG) on the 2/26/2013. In the third part, the burden of proof in liability questions (and 630h BGB) are discussed and critically analysed. In the discussion and a final resume points of criticism of the new law are pointed out.

[Rhinoplasty: medicolegal issues]. / Aspects médico-légaux en rhinoplastie.

In rhinoplasty, satisfying the patient both aesthetically and functionally can be complex. In aesthetic surgery, the rhinoplastician has a reinforced obligation of means. In our experience, the functional outcome of the patient is closely linked to the morphological result. When a rhinoplasty provides the patient with full aesthetic satisfaction, even if he/she has breathing difficulties, there will be very few disputes. In primary rhinoplasty, unsatisfactory results occur in 15%-30% of the cases. While orally informing the patient is paramount, the practitioner must also have written proof of the information via documents given or sent to the various players including the patient. The taking of pre- and postoperative photographs is essential and the surgeon must keep them on file for support in case of conflict.

[Guide to perfect prescribing in Switzerland]. / Wie schreibe ich ein perfektes Rezept in der Schweiz?

An important initial step in the medication process is prescription writing. The more perfect it is, the more successfully can a therapy be performed. Imprecisions and missing information lead to unnecessary queries or to errors which are often randomly discovered during a later consultation. A "perfect prescription" serves every individual involved in the medication process. The prescription document contains the instructions for the patient, the pharmacist, the nurse, and other health professionals involved in the therapy. The prescription writing process is regulated by several laws and decrees which were enacted to assure the greatest possible drug safety. Deviations from the norm may be necessary in individual cases, which require an even more responsible prescribing and explicit indication.

Breast density legislation. Implications for patients and primary care providers.

Minnesota recently became the 16th state to require facilities that perform mammograms to notify patients if they are found to have dense or extremely dense breasts, as this may make it more difficult to detect a cancer or put them at increased risk for cancer. This article outlines the new law and describes the classification system for breast density, the implications for breast density on screening mammography, and the relationship between breast density and cancer. It also provides guidance for patients who have dense breast tissue regarding supplementary screening.

Comparative effectiveness research in clinical practice.

The Agency for Healthcare Research and Quality (AHRQ) has funded systematic reviews of comparative effectiveness research in 17 areas over the last 10 years as part of a federal mandate. These reviews provide a reliable and unbiased source of comprehensive information about the effectiveness and risks of treatment alternatives for patients and clinicians. This article describes comparative effectiveness research, provides an overview of how physicians can use it in clinical practice, and references important contributions made by the Minnesota Evidence-based Practice Center.

[Current medicolegal and ethical issues in pathology]. / Aktuelle medizinrechtliche und -ethische Herausforderungen der Pathologie.

The increase in density of information available in relation to patients and research participants, in particular in the context of genetic diagnostics and analysis, results in an increased potential for uncovering details which were unexpected but are of particular significance for the patient. Deciding how this information is dealt with and who is entitled to receive this information, is a medicolegal and ethical balancing act. Incidental findings and the challenges posed by the advent of personalised medicine are but two areas which increasingly impact medical disciplines that do not conventionally work directly with patients. Both areas raise questions of what is legally required and morally necessary. The authors briefly sketch these two areas and the medicolegal and ethical implications for diagnostics and research in pathology.