bluuebunny/crossref_metadata_2025 huggingface dataset:
Differential Pricing of Pharmaceuticals and Retail Competition Under the Robinson-Patman Act
Authors: Abood Richard R.
Published: February 2021

Emphasis on cost containment by third-party payors has intensified economic competition within the health care system, creating powerful market forces which retail pharmacists had not envisioned a few years ago. Hospitals and alternative delivery systems now sell prescription drugs in direct competition with retail pharmacists. These entities are able to purchase their pharmaceuticals from manufacturers at prices far below those of the retailers. Retail pharmacist plaintiffs allege that such activities violate the Robinson-Patman Act which prohibits price discrimination. Retail pharmacists have achieved landmark victories in decisions establishing that nonprofit, state and local governmental hospitals reselling pharmaceuticals in competition with retail pharmacies are not exempt from the Act. This Article demonstrates that despite these victories, plaintiffs will have difficulty proving an actual violation of the Act by manufacturers and hospitals. Plaintiffs must establish competitive injury as well as refute the meeting competition defense. Retail pharmacists might discover that the Robinson-Patman Act is not the ally they had hoped for; instead, they should concentrate on innovative alternatives which will allow them to compete in an evolving health care system.
Fetal Protection and Potential Liability: Judicial Application of the Pregnancy Discrimination Act and the Disparate Impact Theory
Authors: Moelis Laurence S.
Published: February 2021

“Fetal vulnerability programs,” which are employer attempts to protect employees' unborn fetuses from harm caused by the mothers' exposure to hazardous material in the workplace, have been challenged as a form of employment discrimination. This Note analyzes the recent judicial application of the Pregnancy Discrimination Act (PDA) and the disparate impact theory to fetal vulnerability cases. The Note also examines the business necessity defense's accommodation of legitimate employer interests. The Note concludes that a more potent business necessity defense, a stricter standard for evaluating alternative protective measures, and a judicial interpretation of the PDA which is more consistent with congressional intent are necessary for fair and reasonable resolution of these cases.
The New Biology and the Question of Personhood: Implications for Abortion
Authors: Milby T.H.
Published: February 2021

Opposition to abortion is based in part on the assumption that personhood is achieved at or shortly after fertilization of the egg. This interpretation of personhood arises from a contemporary application of the ancient doctrine of preformationism, a doctrine which holds that there is a preformed individual, in an ontological sense, within the developing entity. The assumption that the fertilized egg is unique in its capacity to develop into a human being is at least in part responsible for the opinions of those opposed to abortion. Yet, the uniqueness of the zygote in its capacity to develop into an adult organism is qualified by the discovery that development may be possible in a number of other ways. Consideration of the phenomena of cloning, parthenogenesis and chimerism can relieve moral ambiguity about abortion and may reduce opposition to that practice.
Sexual Abuse by Psychotherapists: The Call for a Uniform Criminal Statute
Authors: Borruso Michael T.
Published: February 2021

Recent surveys show an alarming rate of sexual exploitation of patients by psychotherapists. As such conduct often falls outside the scope of rape, which allows a defense of consent, the psychotherapist is not prosecuted. Although all sexual contact between therapist and patient is prohibited by codes of professional ethics, the licensing boards that enforce these codes do not possess adequate power to deter this behavior. Further, professional review boards have absolutely no authority over unlicensed therapists who sexually abuse their patients. As a result, licensed therapists who have been censured in one state may practice as unlicensed therapists in another state and continue to sexually abuse patients.

The only effective deterrent would be a uniform statute, adopted in all states, criminalizing this specific abuse of the unique therapist-patient relationship. Such a statute should include unlicensed therapists as potential offenders and consent to sexual contact should not be a defense. The statute also should provide for enhanced efforts to inform and protect victims. This Note first examines six of the nine criminal statutes that currently exist in order to show the full range of provisions presently in force to deter this conduct. This Note then proposes model provisions for a uniform statute.
Urea Formaldehyde Foam Insulation: Defusing a Timebomb
Authors: Fox Edward M.
Published: February 2021

With the onset of the energy crisis in the 1970’s, thousands of homeowners insulated their homes with Urea Formaldehyde Foam Insulation (UFFI). The discovery that UFFI releases formaldehyde, a carcinogen and irritant, prompted various state and federal responses to this problem. This Note reviews those responses and concludes that a ban on the sale of UFFI, coupled with a removal and repurchase program, is the most effective solution from the standpoint of consumer health.
Bioethical and Legal Considerations in Increasing the Supply of Transplantable Organs: From UAGA to “Baby Fae”
Authors: Schwartz Howard S.
Published: February 2021

In the last 35 years, organ transplant technology has advanced greatly. The major problem associated with organ transplantation is organ availability, and not surgery-related mortality. This article examines current organ procurement procedures and technologies, legislative repsonses to the scarcity of transplantable organs, as well as the psychological barriers to organ donation. Issues of fairness in the allocation of scarce economic and social resources, the role of religion and ethics in organ donation and transplantation decision, and the impact of the media are also considered.
State Medical Peer Review: High Cost But No Benefit—Is It Time for a Change?
Authors: Scheutzow Susan O.
Published: February 2021

The medical community and policy-makers have widely accepted peer review of physicians as essential to encouraging high quality medical practice. Peer review is a process by which members of a hospital's medical staff review the qualifications, medical outcomes and professional conduct of other physician members and medical staff applicants to determine whether the reviewed physicians may practice in the hospital and, if so, to determine the parameters of their practice.
Medicare+Choice Appeal Procedures: Reconciling Due Process Rights and Cost Containment
Authors: Gladieux Jennifer E.
Published: February 2021

By signing the Balanced Budget Act of 1997 (BBA) on August 5, 1997, President Clinton made the most significant changes to Medicare, since its inception in 1965, by adopting market-driven reforms in an effort to balance the federal budget. One of the most significant Medicare reforms in the BBA was the creation of the Medicare+Choice program that provides Medicare beneficiaries access to a wide array of private health plan choices as well as traditional fee-for-service (FFS) Medicare. In addition, Medicare+Choice enables Medicare to further utilize delivery innovations, including preferred provider organizations (PPOs), openended health maintenance organizations (HMOs), point-of-service plans, provider sponsored organizations (PSOs), integrated delivery systems (IDSs) and primary care case management, that have helped the private sector contain costs and expand health care delivery options.
Sex Offenders, Mental Illness and Criminal Responsibility: The Constitutional Boundaries of Civil Commitment after Kansas v. Hendricks
Authors: Falk Adam J.
Published: February 2021

To allow the state to first choose the criminal sanction, which requires a finding of a specific state of mind, and when that sanction is completed, to choose another sanction which requires a finding of the opposite state of mind, is a mockery of justice which places both the criminal and civil systems for dealing with sexual predators in disrepute.

By committing individuals based solely on perceived dangerousness, the Statute in effect sets up an Orwellian “dangerousness court,” a technique of social control fundamentally incompatible with our system of ordered liberty guaranteed by the constitution….
Reallocating Liability to Medical Staff Review Committee Members: A Response to the Hospital Corporate Liability Doctrine
Authors: Peters Gregory G.
Published: February 2021

Under the doctrine of hospital corporate liability, the hospital governing board bears the responsibility for detecting the incompetence of its staff physicians. Since hospital governing boards are generally composed of lay community members, they lack the expertise to evalutate the clinical competence of their staff. Therefore, they must delegate their screening responsibilities to medical staff review committees. After analyzing the development of hospital corporate liabilty doctrine, this Note examines the respective policing capabilities of review committees and the governing board. The Note contends that the board should not be held liable for aspects of the policing process which it is incapable of controlling. The Note concludes that, given their superior ability to evaluate clinical competency, staff review committees should shoulder the responsibility for the clinical aspects of staff evaluation, leaving remaining aspects to the hospital governing board. The Note proposes that courts should recognize a cause of action for negligence against medical staff review committee members in order to upgrade the effective policing of the medical profession.
The Biomedical Researcher and Subpoenas: Judicial Protection of Confidential Medical Data
Authors: Holder Angela R.
Published: February 2021

An increasing number of medical researchers are being subpoenaed to testify or to supply records in cases in which they have not agreed to become involved as expert witnesses. The researchers’ published works are alleged to have formed the basis of the opinions of physicians testifying as expert witnesses in these cases. Although the courts usually protect confidential medical data, the considerable burden of quashing these subpoenas is still imposed upon researchers and their universities. This Article argues that courts should protect these research records from subpoenas.
The Incompetent Developmentally Disabled Person's Right of Self-Determination: Right-to-Die, Sterilization and Institutionalization
Authors: Krais William A.
Published: February 2021

The developmentally disabled, specifically those mentally incompetent from birth, are entitled to a full panoply of constitutional rights and protections. These rights include the right to terminate life-sustaining treatment, the right of procreative integrity and the right not to be involuntarily institutionalized. However, the mentally incompetent developmentally disabled are generally unable to exercise these rights. This Note asserts first that proper procedural safeguards are necessary to guarantee the exercise of these constitutional rights by the incompetent disabled individual. Second, the Note focuses upon how best to preserve the disabled person's autonomy. The Note subsequently rejects the substituted judgment standard as a legal fiction, and endorses the best interest test which necessarily comports with the evidence, and properly accounts for the disabled person's incompetency.
A Decade of a Maturing Epidemic: An Assessment and Directions for Future Public Policy
Authors: Gostin Larry
Published: February 2021

It has been nearly a decade since the first cases of AIDS were reported by the United States Centers for Disease Control (CDC). During that time there have been over 200 statutes enacted in every jurisdiction in the country. Unfortunately, the content of the legislation is highly diverse, even inconsistent, from state to state, and there is very little guiding federal legislation or regulation. The profound social, moral and public policy dilemmas that are magnified by the Human Immunodeficiency Virus (HIV) epidemic are still no closer to resolution. Should testing for HIV infection be voluntary, routine or compulsory when there is a higher risk of transmission of HIV? Should America return to traditional moral values of abstinence outside of marriage and zero tolerance of drug use, or should we teach safe sex and use of sterile injection equipment? Should health care professionals maintain strict confidentiality or do they have a duty to protect third parties in imminent danger?
State Regulations and the HIV-Positive Health Care Professional: A Response to a Problem that Does Not Exist
Authors: DiMaggio Susan L.
Published: February 2021

An announcement in July 1990 concerning the possible transmission of the Human Immunodeficiency Virus from an HIV-positive health care professional to a patient launched a public outcry for patient protection from acquiring HIV from health care professionals. As a result of numerous debates, Congress issued a mandate requiring the states to adopt the Centers for Disease Control and Prevention's guidelines concerning HIV-positive health care professionals or an equivalent policy. This Note explores the regulations and guidelines established by various states in response to this mandate. The author concludes that policies requiring adherence to universal precautions within the health care setting, and not mandatory testing of health care professionals or mandatory disclosure of their HIV status, are best for protecting public health.
Legal & Ethical Safeguards: Protection of Society's Most Vulnerable Participants in a Commercialized Organ Transplantation System
Authors: Banks Gloria J.
Published: February 2021

Legal and ethical questions regarding existing organ transplant procurement policies and practices are numerous and unsettling. They arise because transplantable organs are scarce. The scarcity of such organs has been the hue and cry of several medical and legal scholars. For example, the scarcity creates competition among those who wait, necessitating equitable organ allocation procedures and guidelines. Medical obstacles surround the determination of when, how, and on whom such procedures can be performed successfully. Other obstacles range from finding a suitable donor for proper “matching” with the intended donee, to the time constraints involved in preserving excised organs until transplantation, to the donee's ability to fight off rejection of transplanted organs. There is also the obstacle of locating available organs. As medical technology continues to advance, the number of possible organ sources increases. Currently, these sources have included live human donors, cadavers, mechanical devices, animals, fetuses, anencephalic infants, and “brain-dead” donors.
Juries and Crime Labs: Correcting the Weak Links in the DNA Chain
Authors: McDonald Ryan
Published: February 2021

After a decade of courtroom battles and heated academic debate, the United States has entered an age where the scientific validity of deoxyribonucleic acid (DNA) evidence is not subject to serious dispute. The problem with DNA evidence is no longer one of validity, but one of proficiency. Two confounding variables in the DNA testing process weaken and often destroy DNA's powerfulness and usefulness in the courtroom: crime labs and juries.

This Note proposes new and stringent standards for the admissibility of DNA evidence. The admissibility of forensic DNA evidence must be conditioned on its examination by a crime lab governed by uniform national standards. Such governing national standards must encompass every aspect of the forensic process, from chain of custody to DNA testing procedures, in order to ensure the reliability of DNA evidence. Implementing such a comprehensive national standard, however, only represents a first step toward solving the problem of DNA evidence in the courtroom. This step, however, fails to address the second problem facing the effective use of DNA in courtrooms: juries.
Protecting Genetic Privacy by Permitting Employer Access Only to Job-Related Employee Medical Information: Analysis of a Unique Minnesota Law
Authors: Rothstein Mark A. , Gelb Betsy D. , Craig Steven G.
Published: February 2021

One of the most frequently expressed concerns about new scientific discoveries resulting from the Human Genome Project is the potential for genetic discrimination in insurance and employment. The issue of discrimination in insurance, primarily health insurance, has justifiably received widespread attention in the scholarly literature. Among other research, there has been a special task force on insurance of the Joint Working Group on Ethical, Legal, and Social Implications of the Human Genome Project, a special committee report of the National Action Plan on Breast Cancer, a special report of the American Council of Life Insurance and the Health Insurance Association of America and numerous reports and scholarly articles.

The ethical, legal and social implications of genetic discrimination in employment, although widely recognized as being very important, have received somewhat less attention than genetic discrimination in health insurance. Undoubtedly, much of the concern about genetic discrimination in employment arises from the relationship between employment and group health insurance. However, there are other problems. The disclosure of sensitive genetic information may result in invasions of privacy and breaches of confidentiality in obtaining the information and the loss of employment means denial of the opportunity to earn a livelihood for individuals determined to be at genetic risk. As a result, many at-risk individuals forego genetic testing because they fear these consequences.
If I Am Only for Myself, What Am I? A Communitarian Look at the Privacy Stalemate
Authors: Rubinstein Helena Gail
Published: February 2021

There is little quarrel that access by medical and health policy researchers to medical records and claims data has spurred advances in quality and access to medical treatment. Nevertheless, dissatisfaction lingers with the regime used to regulate access to that information. The American regulatory regime on medical record access has politely been characterized as “fragmented” and less politely as a “black hole.” U.S. Senator Edward M. Kennedy asserts, “[t]oday, video rental records have greater protection than sensitive medical information.” At the center of this dissatisfaction is the question of how much say an individual should have in letting others—even those with legitimate need—look at and use an individual's records.
Online Without a Net: Physician-Patient Communication by Electronic Mail
Authors: Spielberg Alissa R.
Published: February 2021

Patients continue to find new ways of reaching their physicians. In the past, patients and their health care providers developed relationships through the course of everyday affairs and across a wide variety of social exchanges. Although other methods of communicating were introduced into the medical context, telephones, pagers and voicemail all retained some connection to individual voices. Moreover, medical practitioners and patients alike never anticipated that these technologies would substitute for genuine personal interactions. Nor did they anticipate that another new technology, electronic mail (e-mail), would shift communications back in time to the days when letter writing formed the basis for diagnosing and relating. E-mail in medical practice has already begun to reconfigure the patient-physician relationship in the electronic age.
Informed Consent in the Electronic Age
Authors: Rosoff Arnold J.
Published: February 2021

Dr. X, a urologist, has just told his patient, Mr. Y, a fifty-eight-year-old businessman, that he has prostate cancer. The revelation was difficult for both parties, but it did not come as a complete surprise because it had been preceded by a multistep diagnostic process. Although hoping for better, Mr. Y and his wife were expecting this bad news when they went into the doctor's office.

After offering some words of hope and encouragement, Dr. X tells the patient and his wife that, before they discuss any further the important choices that lie ahead in the treatment of Mr. Y's condition, he would like them to take time to review carefully the information contained in the CD-ROM program he has just handed them. The program, entitled “Living with a Diagnosis of Prostate Cancer,” is one of a library of such programs developed and marketed by a company specializing in computer-based patient education products.
The Globalization of Health Law: The Case of Permissibility of Placebo-based Research
Authors: Jost Timothy S.
Published: February 2021

If any trend can be confidently predicted for the next millennium (or, more modestly, for our lifetimes) it is the globalization of health law. We live in an age of global markets and global communications. While care of the individual patient has remained largely local, national borders are quite porous to health care professionals. The cross-border flow of patients is a significant factor in some regions, and the development of telemedicine and internet pharmacies is radically expanding the possibility of cross-border medical practice.
Regulating Medical Practice in the Cyber Age: Issues and Challenges for State Medical Boards
Authors: Silverman Ross D.
Published: February 2021

“On the Internet, nobody knows you're a dog,” says one canine to another as they sit in front of a computer in the classic New Yorker cartoon. This can also apply to those who seek or provide medical care online. On the Internet, nobody knows if you're male or female, elderly or adolescent, fit or obese, hirsute or bald, virile or impotent. In addition, in many cases, nobody knows if the “physician” or “pharmacist” on the other end of the line is a properly licensed physician or pharmacist, where they are located, what the knowledge level or training of the consulting practitioner is, or whether the medications being shipped are of the appropriate level of quality, potency or dosage. And, if the ease with which one is able to procure pharmaceuticals online is any indication, there are plenty of unscrupulous entrepreneurs selling drugs on the Internet who do not appear to care.
Medical Error as False Claim
Authors: Krause Joan H.
Published: February 2021

[I]n appropriate instances, the U.S. Attorney's Office will act to investigate and pursue systemic substandard care issues, notwithstanding a provider's representation of compliance with administrative requirements.

Medical error and health care fraud are hot topics these days. Since the Fall 1999 publication of the Institute of Medicine (“IOM”) Report,To Err is Human,medical errors have received a great deal of attention in the popular and academic press. Error reporting bills have been introduced at both the state and federal levels, and industry and government representatives have undertaken a variety of cooperative error-reduction efforts.
Making Clinical Trials Safer for Human Subjects
Authors: Baram Michael
Published: February 2021

The pace of medical innovation is quickening, pushed by advances in biotechnology and pulled by growing demand for healthcare. Completion of the Human Genome Project has provided a multitude of data for determining genes and their functions, and stimulated the application of information technology and private capital for the development of new individualized drugs, gene therapies, and biomaterials for tissue and organ regeneration. Concurrently, demand for healthcare continues to grow, expanding the market for medical innovations that are proven in clinical trials to be safe and effective.
How Judicial Myopia Is Jeopardizing the Protection of People with HIV/AIDS Under the ADA
Authors: Maida Tony R.
Published: February 2021

The Americans with Disabilities Act of 1990 promised to be a “secondgeneration” civil rights statute, comparable in importance and scope to the Civil Rights Act of 1964. The breadth of the act reflected congressional and disability activists' desire to change society in order to enable the disabled to achieve economic autonomy and social equality. Historically, disabled individuals were characterized by their inability to normally function in society, either due to physical obstacles or social myths and stereotypes. Up until 1990, the federal government had taken baby steps to address these issues. Indeed, most federal activity was limited to assisting disabled people in overcoming physical barriers to employment. However, the government did little to change the structure of those barriers, and most certainly did not address the widespread social prejudice against the disabled.
Protecting the Endangered Human: Toward an International Treaty Prohibiting Cloning and Inheritable Alterations
Authors: Annas George J. , Andrews Lori B. , Isasi Rosario M.
Published: February 2021

We humans tend to worry first about our own happiness, then about our families, then about our communities. In times of great stress, such as war or natural disaster, we may focus temporarily on our country but we rarely think about Earth as a whole or the human species as a whole. This narrow perspective, perhaps best exemplified by the American consumer, has led to the environmental degradation of our planet, a grossly widening gap in living standards between rich and poor people and nations and a scientific research agenda that focuses almost exclusively on the needs and desires of the wealthy few. Reversing the worldwide trends toward market-based atomization and increasing indifference to the suffering of others will require a human rights focus, forged by the development of what Vaclav Havel has termed a “species consciousness.”
Risky Business: Proposed Reform of the Antitrust Laws As Applied to Health Care Provider Networks
Authors: Marjancik Natalie
Published: February 2021

Because the health care industry comprises over thirteen percent of the American economy, law enforcers increasingly apply antitrust law to all aspects of health care delivery and financing. Through antitrust enforcement, consumers receive the benefits of lower health care costs and improved health care services. To achieve further cost savings, health care providers are forming, as well as joining, many different types of provider network joint ventures. Providers form networks, expect ing “them to generate efficiencies, reduce excess capacity, improve utilization, permit greater specialization and enhance quality.” However, because they organize competing physicians and enable them to collaborate on prices and set fee schedules, provider networks raise serious antitrust concerns. Consequently, the federal government and courts are increasingly focusing their antitrust enforcement efforts on the formation and anticompetitive activities of provider networks.

In Part I, this Note addresses the degree to which network providers must be economically and financially integrated to legally collaborate and set prices. Part II briefly explains the procedures one may use to enforce the federal antitrust laws. Following this explanation of antitrust enforcement procedures, Part III discusses the relevant statutory and case law applicable to health care provider networks.
Physician Deselection: The Dynamics of a New Threat to the Physician-Patient Relationship
Authors: Liner Richard S.
Published: February 2021

Dr. Julia Green is a primary care physician (PCP) licensed to practice medicine in the Commonwealth of Massachusetts. On October 1, 1994, Dr. Green signed a one-year, renewable contract with Allcare Health Plan (AHP). Pursuant to the terms of the contract, on January 1, 1995, AHP placed her on its select list of PCPs available to its 100,000 covered lives (“enrollees”). Dr. Green provided for all primary care and specialist referrals for those enrollees who chose her as their physician. AHP paid her on a fee-for-service (FFS) basis for all preapproved procedures and treatments.

Dr. Green felt that this contract might decrease her autonomy slightly; however, she also felt that it would increase her patient pool significantly and lessen the burden of collecting fees directly from patients. Dr. Green knew that choosing not to sign the contract would preclude AHP enrollees from making her their PCP because AHP only covered treatment provided by its own physicians. She further feared that as enrollment in managed care organizations (MCOs) increases, and more of her colleagues sign managed care contracts, her pool of potential patients would decrease drastically.
Websterand the Fundamental Right to Make Medical Decisions
Authors: Orentlicher David
Published: February 2021

The interest of the eight major organizations of health care professionals was not in debating the philosophical, ethical, moral or religious issues surrounding abortion. The members of the organizations differ on how to balance the woman's privacy right against the state's interests in maternal and fetal health, and in particular about whether the state has a compelling interest in fetal health before viability. Given the diversity of views, the brief neither endorsed nor opposed the Supreme Court's holding inRoe v. Wadethat the state's interest in fetal health becomes compelling at viability.
Biased preferences equilibrium
Authors: Rubinstein Ariel , Wolinksy Asher
Published: February 2021

We model economic environments in which individual choice sets are fixed and the level of a specific parameter that systematically modifies the preferences of all agents is determined endogenously to achieve equilibrium. The equilibrium concept, Biased Preferences Equilibrium, is reminiscent of competitive equilibrium: agents’ choice sets and their preferences are independent of the behaviour of other agents, the combined choices must satisfy overall feasibility constraints and the endogenous adjustment of the equilibrating preference parameter is analogous to equilibrating price adjustment. The concept is applied in a number of economic examples.
What’s in, what’s out? Towards a rigorous definition of the boundaries of benefit-cost analysis
Authors: Acland Daniel
Published: February 2021

Benefit-cost analysis (BCA) is typically defined as an implementation of the potential Pareto criterion, which requires inclusion of any impact for which individuals have willingness to pay (WTP). This definition is incompatible with the exclusion of impacts such as rights and distributional concerns, for which individuals do have WTP. I propose a new definition: BCA should include only impacts for which consumer sovereignty should govern. This is because WTP implicitly preserves consumer sovereignty, and is thus only appropriate for ‘sovereignty-warranting’ impacts. I compare the high cost of including non-sovereignty-warranting impacts to the relatively low cost of excluding sovereignty-warranting impacts.
Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements
Authors: Sievers Hannah , Joos Angelika , Hiligsmann Mickaël
Published: February 2021

Objective

This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements.

Methods

Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings.

Results

All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV.

Conclusions

This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.
Mobile isolation wards in a fever clinic: a novel operation model during the COVID-19 pandemic
Authors: Cheng Anbang , Chen Yilin , Gao Yong , Sun Peng , Chang Rui , Zhou Bin , Qiu Hui , Cheng Fanjun
Published: February 2021

A fever clinic within a hospital plays a vital role in pandemic control because it serves as an outpost for pandemic discovery, monitoring and handling. As the outbreak of coronavirus disease 2019 (COVID-19) in Wuhan was gradually brought under control, the fever clinic in the West Campus of Wuhan Union Hospital introduced a new model for construction and management of temporary mobile isolation wards. A traditional battlefield hospital model was combined with pandemic control regulations, to build a complex of mobile isolation wards that used adaptive design and construction for medical operational, medical waste management and water drainage systems. The mobile isolation wards allowed for the sharing of medical resources with the fever clinic. This increased the capacity and efficiency of receiving, screening, triaging and isolation and observation of patients with fever. The innovative mobile isolation wards also controlled new sudden outbreaks of COVID-19. We document the adaptive design and construction model of the novel complex of mobile isolation wards and explain its characteristics, functions and use.
Cellular and molecular alterations of buffalo oocytes cultured under two different levels of oxygen tension during in vitro maturation
Authors: Ghanem Nasser , Ahmed Dalia Abd-El Rahman , Dessouki Sherif Mohamed , Faheem Marwa Said , Gad Ahmed Yehia , Peippo Jaana , Barkawi Ashraf Hesham
Published: February 2021

This study was conducted to monitor the cellular and molecular changes of buffalo cumulus–oocytes complexes (COCs) cultured under high or low oxygen levels. Morphologically good quality COCs (n = 1627) were screened using brilliant cresyl blue (BCB) staining and placed into three groups (BCB+, BCB− and control). All groups of COCs were cultured under low (5%) or high (20%) oxygen tensions. Intracellular and molecular changes including oocyte ultrastructure, lipid contents, mitochondrial activity and transcript abundance of genes regulating different pathways were analyzed in the matured oocyte groups. The results revealed that oxygen tension did not affect cumulus expansion rates, however the BCB+ group had a higher (P ≤ 0.05) expansion rate compared with the BCB− group. BCB− oocytes recorded the lowest meiotic progression rate (P ≤ 0.05) under high oxygen levels that was linked with an increased level of reactive oxygen species (ROS) compared with the BCB+ oocytes. Ultrastructure examination indicated that BCB+ oocytes had a higher rate of cortical granules migration compared with BCB− under low oxygen tension. In parallel, our results indicated the upregulation of NFE2L2 in groups of oocytes cultured under high oxygen tension that was coupled with reduced mitochondrial activity. In contrast, the expression levels of MAPK14 and CPT2 genes were increased (P ≤ 0.05) in groups of oocytes cultured under low compared with high oxygen tension that was subsequently associated with increased mitochondrial activity. In conclusion, data from the present investigation indicated that low oxygen tension is a favourable condition for maintaining the mitochondrial activity required for nuclear maturation of buffalo oocytes. However, low-quality oocytes (BCB−) responded negatively to high oxygen tension by reducing the expression of gene-regulating metabolic activity (CPT2). This action was an attempt by BCB− oocytes to reduce the increased levels of endogenously produced ROS that was coupled with decreased expression of the gene controlling meiotic progression (MAPK14) in addition to nuclear maturation rate.
Improved outcomes after implementation of a specialized pediatric cardiac rapid response team
Authors: McKeta Angela S. , Hlavacek Anthony M. , Chowdhury Shahryar M. , Scheurer Mark , Graham Eric M. , Zyblewski Sinai C. , Buckley Jason R.
Published: February 2021

Introduction:

The efficacy of a specialized pediatric cardiac rapid response team is unknown. We hypothesized that a specialized cardiac rapid response team would facilitate team-wide communication between the cardiac stepdown unit and cardiac intensive care unit (ICU) teams and improve patient care.

Materials and methods:

A specialized pediatric cardiac rapid response team was implemented in June 2015. All pediatric cardiac rapid response team activations and outcomes from implementation through December 2018 were reviewed. Cardiac arrests and unplanned transfers to the cardiac ICU were indexed to 1000 patient-days to account for inpatient volume trends and evaluated over time.

Results:

There were 202 cardiac rapid response team activations in 108 unique patients during the study period. After implementation of the pediatric cardiac rapid response team, unplanned transfers from the cardiac stepdown unit to the cardiac ICU decreased from 16.8 to 7.1 transfers per 1000 patient days (p = 0.012). The stepdown unit cardiac arrest rate decreased from 1.2 to 0.0 arrests per 1000 patient-days (p = 0.015). There was one death on the cardiac stepdown unit in the 5 years since the implementation of the cardiac rapid response team, compared to four deaths in the previous 5 years.

Conclusions:

A reduction in unplanned cardiac ICU transfers, cardiac arrests, and mortality on the cardiac stepdown unit has been observed since the implementation of a specialized pediatric cardiac rapid response team. A specialized cardiac rapid response team may improve communication and empower the interdisciplinary care team to escalate care for patients experiencing clinical decline.
Job strain is prospectively associated with a lower frequency of fruit consumption in schoolteachers
Authors: Rodrigues Renne , Birolim Marcela Maria , de Andrade Selma Maffei , González Alberto Durán , Mesas Cézar Eumann , Fernández-Rodríguez Rubén , Mesas Arthur Eumann
Published: February 2021

Objective:

The current study aimed to analyse the prospective association between perceived work demand and changes in eating behaviours in schoolteachers.

Design:

This was a prospective cohort study with self-reported information obtained on the Demand Control Support Questionnaire and eating behaviours at baseline and after a 2-year follow-up. The analyses were performed using mixed-effects models adjusted for the main confounders.

Setting:

The setting consisted of elementary and secondary schools located in a large city in southern Brazil.

Participants:

The participants were 502 schoolteachers (65·9 % females, median age of 42·7 years [interquartile range 34·2, 49·4]).

Results:

A total of 39·2 % of the schoolteachers were classified at baseline with job strain, 28·9 % with passive job, 12·2 % with active job and 19·7 % with low-strain job. In the fully adjusted models, compared with teachers who reported low-strain job, those with higher levels of job strain were more likely to reduce (coefficient = 0·064; 95 % CI 0·018, 0·109) and less likely to increase (coefficient = −0·066; 95 % CI −0·115, −0·016) their frequency of fruit consumption regardless of sociodemographic, lifestyle, health conditions and social support at work.

Conclusion:

Job strain plays a relevant role in the frequency of fruit consumption over time in schoolteachers. The balance between demand and control at work must be considered in strategies for promoting healthy eating despite perceived social support.
Airborne Dust Plumes Lofted by Dislodged Ice Blocks at Russell Crater, Mars
Authors: Dinwiddie Cynthia L. , Titus Timothy N.
Published: February 2021

Linear dune gullies on poleward‐facing Martian slopes are enigmatic. Formation by CO2‐ice block or snow cornice falls has been proposed based on optical imagery of bright, high‐albedo features inside gully channels. Because these features often resemble patchy frost residue rather than three‐dimensional blocks, more evidence is needed to support the ice‐block formation mechanism. Satellite imagery captured two simultaneous airborne plumes with in‐channel sources at the Russell crater megadune, thrust up, and dispersed outward along the path of linear dune gullies. We use spectral data analyses, climatic analyses of bolometric temperatures, and thermal modeling to further develop the mechanistic framework for linear dune gully development. Basal sublimation and CO2 gas venting likely cause CO2‐ice‐block detachment and falls from gully alcoves in southern early spring, accompanied by ice‐block off‐gassing and saltation of sands and coarse silts that are redeposited around gully channels, and lofting of sublimation lag (coarse dust/silt) into airborne plumes.
Crustal Radial Anisotropy of the Iran Plateau Inferred From Ambient Noise Tomography
Authors: Movaghari R. , JavanDoloei G. , Yang Y. , Tatar M. , Sadidkhouy A.
Published: February 2021

This study presents a three‐dimensional (3D) model of the crustal and uppermost mantle shear wave velocity and radial anisotropy beneath the Iran Plateau constructed by Rayleigh and Love waves from ambient noise. We correlate three years of continuous seismic ambient noise data recorded in 98 stations to obtain cross correlation functions. Then, we measure Rayleigh (8–60 s) and Love (8–50 s) wave dispersion curves from these cross‐correlation functions to generate two‐dimensional dispersion maps using a fast marching surface tomography method. Finally, we build a quasi‐3D shear wave velocity and radial anisotropy model by jointly inverting Rayleigh and Love local phase velocity dispersion curves using a Bayesian Markov chain Monte Carlo inversion method. Observed radial anisotropy beneath Central Iran is weaker than adjacent areas. Negative radial anisotropy is observed in the shallow structures across our study region, which is most likely attributed to vertically aligned cracks in the upper crust. Strong positive radial anisotropy in the middle to the lower crust beneath the Zagros is imaged, which is associated with ductile shear zones in the crust. Radial anisotropy changes from positive values in the crust to negative values in the upper mantle beneath the Zagros, which may be evidence for the decoupling of the crust from the upper mantle beneath the Zagros.
Electrical Resistivity Structure Around the Atotsugawa Fault, Central Japan, Revealed by a New 2‐D Inversion Method Combining Wideband‐MT and Network‐MT Data Sets
Authors: Usui Yoshiya , Uyeshima Makoto , Ogawa Tsutomu , Yoshimura Ryokei , Oshiman Naoto , Yamaguchi Satoru , Toh Hiroaki , Murakami Hideki , Aizawa Koki , Tanbo Toshiya , Ogawa Yasuo , Nishitani Tadashi , Sakanaka Shin 'ya , Mishina Masaaki , Satoh Hideyuki , Goto Tada‐nori , Kasaya Takafumi , Mogi Toru , Yamaya Yusuke , Shiozaki Ichiro , Honkura Yoshimori
Published: February 2021

The Atotsugawa fault is one of the most active faults in Japan, and the strain accumulation at the fault is considered to be caused by an aseismic shear zone in the fluid‐rich lower crust. To identify the shear zone and investigate the origin of the aqueous fluid in the lower crust, we deployed a Network‐MT survey in addition to a conventional wideband‐MT survey around the fault and performed an inversion combining both the MT data sets. In the inversion, by modifying a conventional inversion algorism, we accurately represented kilometer‐scale dipoles of the Network‐MT measurement to provide constraints on the electrical resistivity structure. In the lower crust under the study area, there are localized conductive anomalies below the Atotsugawa fault, the Ushikubi fault, and the Takayama‐Oppara fault zone. Comparing our electrical resistivity structure with the seismic velocity structure, we interpreted that the lower‐crustal conductors are localized ductile shear zones with highly connected fluid. We considered that the localized ductile shear zones are responsible for the strain accumulation along the respective active faults. In addition, in the mantle wedge above the subducting Philippine Sea slab and its downward extension, a highly conductive portion is detected, which may be attributed to the fluid dehydrated from the Philippine Sea slab and/or the Pacific slab. The existence of the large conductive area supports the suggestion of previous seismic and geochemical studies that the fluid of the lower crust around the Atotsugawa fault originated from subducting slabs.
Microphysical Modeling of Carbonate Fault Friction at Slip Rates Spanning the Full Seismic Cycle
Authors: Chen Jianye , Niemeijer A. R. , Spiers Christopher J.
Published: February 2021

Laboratory studies suggest that seismogenic rupture on faults in carbonate terrains can be explained by a transition from high friction, at low sliding velocities (V), to low friction due to rapid dynamic weakening as seismic slip velocities are approached. However, consensus on the controlling physical processes is lacking. We previously proposed a microphysically based model (the “Chen–Niemeijer–Spiers” [CNS] model) that accounts for the (rate‐and‐state) frictional behavior of carbonate fault gouges seen at low velocities characteristic of rupture nucleation. In the present study, we extend the CNS model to high velocities (1 mm/s ≤ V ≤ 10 m/s) by introducing multiple grain‐scale deformation mechanisms activated by frictional heating. As velocity and hence temperature increase, the model predicts a continuous transition in dominant deformation mechanisms, from frictional granular flow with partial accommodation by plasticity at low velocities and temperatures, to grain boundary sliding with increasing accommodation by solid‐state diffusion at high velocities and temperatures. Assuming that slip occurs in a localized shear band, within which grain size decreases with increasing velocity, the model results capture the main mechanical trends seen in high‐velocity friction experiments on room‐dry calcite‐rich rocks, including steady‐state and transient aspects, with reasonable quantitative agreement and without the need to invoke thermal decomposition or fluid pressurization effects. The extended CNS model covers the full spectrum of slip velocities from earthquake nucleation to seismic slip rates. Since it is based on realistic fault structure, measurable microstructural state variables, and established deformation mechanisms, it may offer an improved basis for extrapolating lab‐derived friction data to natural fault conditions.