Healthcare provider perspectives on parental refusal of medical interventions: A qualitative study

Background. Healthcare providers in pediatrics are faced with parents making medical decisions for their children. Refusal to consent to interventions can have life threatening sequelae, yet healthcare workers are provided little training in handling refusals. The healthcare provider's experience in parental refusal has not been well described, yet is an important first step in addressing this problem. ^ Specific aims. Describe: (1) the decision-making processes made by healthcare providers when parents refuse medical interventions for their children, (2) the source of healthcare workers' skills in handling situations of refusal, and (3) the perspectives of healthcare workers on parental refusals in the inpatient setting. ^ Methods. Nurses, physicians and respiratory therapists (RT) were recruited via e-mail at Texas Children's Hospital (TCH). Interview questions were developed using Social Cognitive Theory constructs and validated. One-on-one in-depth, one hour semi-structured interviews were held at TCH, audio recorded and transcribed. Coding and analysis were done using ATLAS ti. The constant comparative method was applied to describe emergent themes that were reviewed by an independent expert. ^ Results. Interviews have been conducted with nurses (n=6), physicians and practitioners (n=6), social workers (n=3) and RT (n=3) comprising 13 females and 5 males with 3–25 years of experience. Decision-making processes relate to the experience of the caregiver, familiarity with the family, and the acuity of the patient. Healthcare workers' skills were obtained through orientation processes or by trial-and-error. Themes emerged that related to the importance of: (1) Communication, where the initial discussion about a medical procedure should be done with clarity and an understanding of the parents' views; (2) Perceived loss of control by parents, a key factor in their refusal of interventions; and (3) Training, the need for skill development to handle refusals. ^ Conclusions. Effective training involving clarity in communication and a preservation of perceived control by parents is needed to avoid the current trial-and-error experience of healthcare workers in negotiating refusal situations. Such training could lessen the more serious outcomes of parental refusal. ^

Cost analysis of opt-in consent procedures for the Texas statewide immunization information system, ImmTrac

Background. Childhood immunization programs have dramatically reduced the morbidity and mortality associated with vaccine-preventable diseases. Proper documentation of immunizations that have been administered is essential to prevent duplicate immunization of children. To help improve documentation, immunization information systems (IISs) have been developed. IISs are comprehensive repositories of immunization information for children residing within a geographic region. The two models for participation in an IIS are voluntary inclusion, or "opt-in," and voluntary exclusion, or "opt-out." In an opt-in system, consent must be obtained for each participant, conversely, in an opt-out IIS, all children are included unless procedures to exclude the child are completed. Consent requirements for participation vary by state; the Texas IIS, ImmTrac, is an opt-in system.^ Objectives. The specific objectives are to: (1) Evaluate the variance among the time and costs associated with collecting ImmTrac consent at public and private birthing hospitals in the Greater Houston area; (2) Estimate the total costs associated with collecting ImmTrac consent at selected public and private birthing hospitals in the Greater Houston area; (3) Describe the alternative opt-out process for collecting ImmTrac consent at birth and discuss the associated cost savings relative to an opt-in system.^ Methods. Existing time-motion studies (n=281) conducted between October, 2006 and August, 2007 at 8 birthing hospitals in the Greater Houston area were used to assess the time and costs associated with obtaining ImmTrac consent at birth. All data analyzed are deidentified and contain no personal information. Variations in time and costs at each location were assessed and total costs per child and costs per year were estimated. The cost of an alternative opt-out system was also calculated.^ Results. The median time required by birth registrars to complete consent procedures varied from 72-285 seconds per child. The annual costs associated with obtaining consent for 388,285 newborns in ImmTrac's opt-in consent process were estimated at $702,000. The corresponding costs of the proposed opt-out system were estimated to total $194,000 per year. ^ Conclusions. Substantial variation in the time and costs associated with completion of ImmTrac consent procedures were observed. Changing to an opt-out system for participation could represent significant cost savings. ^

Effects of congressional modernization laws on public access to innovative medical device technologies

The Federal Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) play key roles in making Class III, medical devices available to the public, and they are required by law to meet statutory deadlines for applications under review. Historically, both agencies have failed to meet their respective statutory requirements. Since these failures affect patient access and may adversely impact public health, Congress has enacted several “modernization” laws. However, the effectiveness of these modernization laws has not been adequately studied or established for Class III medical devices. ^ The aim of this research study was, therefore, to analyze how these modernization laws may have affected public access to medical devices. Two questions were addressed: (1) How have the FDA modernization laws affected the time to approval for medical device premarket approval applications (PMAs)? (2) How has the CMS modernization law affected the time to approval for national coverage decisions (NCDs)? The data for this research study were collected from publicly available databases for the period January 1, 1995, through December 31, 2008. These dates were selected to ensure that a sufficient period of time was captured to measure pre- and post-modernization effects on time to approval. All records containing original PMAs were obtained from the FDA database, and all records containing NCDs were obtained from the CMS database. Source documents, including FDA premarket approval letters and CMS national coverage decision memoranda, were reviewed to obtain additional data not found in the search results. Analyses were conducted to determine the effects of the pre- and post-modernization laws on time to approval. Secondary analyses of FDA subcategories were conducted to uncover any causal factors that might explain differences in time to approval and to compare with the primary trends. The primary analysis showed that the FDA modernization laws of 1997 and 2002 initially reduced PMA time to approval; after the 2002 modernization law, the time to approval began increasing and continued to increase through December 2008. The non-combined, subcategory approval trends were similar to the primary analysis trends. The combined, subcategory analysis showed no clear trends with the exception of non-implantable devices, for which time to approval trended down after 1997. The CMS modernization law of 2003 reduced NCD time to approval, a trend that continued through December 2008. This study also showed that approximately 86% of PMA devices do not receive NCDs. ^ As a result of this research study, recommendations are offered to help resolve statutory non-compliance and access issues, as follows: (1) Authorities should examine underlying causal factors for the observed trends; (2) Process improvements should be made to better coordinate FDA and CMS activities to include sharing data, reducing duplication, and establishing clear criteria for “safe and effective” and “reasonable and necessary”; (3) A common identifier should be established to allow tracking and trending of applications between FDA and CMS databases; (4) Statutory requirements may need to be revised; and (5) An investigation should be undertaken to determine why NCDs are not issued for the majority of PMAs. Any process improvements should be made without creating additional safety risks and adversely impacting public health. Finally, additional studies are needed to fully characterize and better understand the trends identified in this research study.^

Process to develop a State Model Law to reduce prescription drug trafficking while protecting pain management

This paper will discuss the intersection of pill mills and the under-treatment of pain, while addressing the unintended consequence that cracking down on pill mills actually has on medical professionals' treatment of legitimate pain in clinical settings. Moreover, the impact each issue has on the spectrum of related policy, regulatory issues and legislation will be analyzed while addressing the national impact on medical care. Lastly, this paper will outline a process to develop a State Model Law on this subject. This process will include suggestions for the future and how we can move forward to adequately address public safety needs and how we can attempt to mitigate the unintended impact prescription drug trafficking has had on a patient's right to appropriate pain management. This balance is achievable and this paper will address ways we can find this elusive balancing point through the development of a State Model Law. ^

Implications of Health Care Reform (Medical Ethics Series, 2011)

A video of a panel discussion on how Obama's Health Care Reform would affect Texas Medical Center institutions and health care in general.Speakers include Tom Cole (moderator), Roberta Schwartz (Methodist Hospital), Pauline Rosenau (UT-Houston School of Public Health), and Laurence McCullough (Baylor College of Medicine).

SUPERFUND: AN ANALYSIS OF IMPLEMENTATION FAILURE (CERCLA, HEALTH LAW POLICY)

In December, 1980, following increasing congressional and constituent-interest in problems associated with hazardous waste, the Comprehensive Environmental Recovery, Compensation and Liability Act (CERCLA) was passed. During its development, the legislative initiative was seriously compromised which resulted in a less exhaustive approach than was formerly sought. Still, CERCLA (Superfund) which established, among other things, authority to clean up abandoned waste dumps and to respond to emergencies caused by releases of hazardous substances was welcomed by many as an important initial law critical to the cleanup of the nation's hazardous waste. Expectations raised by passage of this bill were tragically unmet. By the end of four years, only six sites had been declared by the EPA as cleaned. Seemingly, even those determinations were liberal; of the six sites, two were identified subsequently as requiring further cleanup.^ This analysis is focused upon the implementation failure of the Superfund. In light of that focus, discussion encompasses development of linkages between flaws in the legislative language and foreclosure of chances for implementation success. Specification of such linkages is achieved through examination of the legislative initiative, identification of its flaws and characterization of attendant deficits in implementation ability. Subsequent analysis is addressed to how such legislative frailities might have been avoided and to attendant regulatory weaknesses which have contributed to implementation failure. Each of these analyses are accomplished through application of an expanded approach to the backward mapping analytic technique as presented by Elmore. Results and recommendations follow.^ Consideration is devoted to a variety of regulatory issues as well as to those pertinent to legislative and implementation analysis. Problems in assessing legal liability associated with hazardous waste management are presented, as is a detailed review of the legislative development of Superfund, and its initial implementation by Gorsuch's EPA. ^

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Minors’ Access to Contraceptive Services

Over the past 30 years, states have expanded minors’ authority to consent to health care, including care related to sexual activity. This trend reflects U.S. Supreme Court rulings extending the constitutional right to privacy to a minor’s decision to obtain contraceptives and concluding that rights do not “come into being magically only when one attains the state-defined age of majority.” It also reflects the recognition that while parental involvement is desirable, many minors will remain sexually active but not seek services if they have to tell their parents. As a result, confidentiality is vital to ensuring minors’ access to contraceptive services. Even when a state has no relevant policy or case law, physicians may commonly provide medical care to a mature minor without parental consent, particularly if the state allows a minor to consent to related health services.

Women’s experiences with the use of medical abortion in a legally restricted context: the case of Argentina

This article presents the findings of a qualitative study exploring the experiences of women living in Buenos Aires Metropolitan Area, Argentina, with the use of misoprostol for inducing an abortion. We asked women about the range of decisions they had to make, their emotions, the physical experience, strategies they needed to use, including seeking health care advice and in dealing with a clandestine medical abortion, and their overall evaluation of the experience. An in-depth interview schedule was used. The women had either used misoprostol and sought counselling or care at a public hospital (n=24) or had used misoprostol based on the advice of a local hotline, information from the internet or from other women (n=21). Four stages in the women’s experiences were identified: how the decision to terminate the pregnancy was taken, how the medication was obtained, how the tablets were used, and reflections on the outcome whether or not they sought medical advice. Safety and privacy were key in deciding to use medical abortion. Access to the medication was the main obstacle, requiring a prescription or a friendly drugstore. Correct information about the number of pills to use and dosage intervals was the least easy to obtain and caused concerns. The possibility of choosing a time of privacy and having the company of a close one was highlighted as a unique advantage of medical abortion. Efforts to improve abortion law, policy and service provision in Argentina in order to ensure the best possible conditions for use of medical abortion by women should be redoubled.

3.4 MU registrar informed Lloyd Gaines that he was not eligible to attend the University of Missouri due to the fact that Gaines was a Negro

After several weeks, Gaines finally received a reply to his application from Sy Woodson Canada, the MU registrar. Canada informed him that he was not eligible to attend the University of Missouri due to the fact that Gaines was a Negro and it was in conflict of Missouri state law for MU to admit him.

GRADE Evidence to Decision (EtD) frameworks : A systematic and transparent approach to making well-informed healthcare choices. 1. Introduction

Funding: Work on this article has been partially funded by the European Commission FP7 Program (grant agreement 258583) as part of the DECIDE project. Sole responsibility lies with the authors; the European Commission is not responsible for any use that may be made of the information contained therein.

GRADE Evidence to Decision (EtD) frameworks : a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines

Funding: Work on this article has been partially funded by the European Commission FP7 Program (grant agreement 258583) as part of the DECIDE project. Sole responsibility lies with the authors; the European Commission is not responsible for any use that may be made of the information contained therein.

Workmen's compensation acts in the United States: the medical aspect

National Industrial Conference Board.

Laws made and past by William Penn: Absolute Proprietary and Governour in Chief of the province of Pennsylvania and territories thereunto belonging, with the advice and consent of the freemen thereof in genrall assembly met at Newcastle...1700....and [as amended] at Philadelphia...1701

Contains one of the few original copies of Penn's laws as first passed and as revised and extended in the following year. During the interval between the two Assemblies, while Penn was absent in England, the first series of laws were found to be impracticable, and new amendments were made for which Penn had no choice but to agree to.