Every year, 2 million patients in the United States suffer with at least 1 hospital-acquired infection resulting in an estimated 99,000 deaths annually. The purpose of this exploratory single case study was to explore strategies healthcare managers in U.S. hospitals used to reduce hospital-acquired infections. The study included face-to-face, semistructured interviews with 5 healthcare managers from a hospital in Maryland who were successful in reducing these infections. The conceptual framework was human capital theory. Field notes, hospital documents, and transcribed interviews were analyzed to identify themes regarding strategies used by healthcare managers. The data analysis and coding process resulted in 5 major themes: use of HAI-related data; implementation of detailed cleaning method; implementation of define, measure, analyze, implement, and control; education and training of staff; and implementation of the Antimicrobial Stewardship Program. The findings from this study might benefit healthcare managers in implementing and sustaining successful strategies to reduce hospital-acquired infections. The implications for positive social change included reducing hospital-acquired infections, thereby leading to fewer hospitalization days for patients and a faster recovery time to return to normal life. Reducing hospital acquired infections might reduce patient deaths related to the infections.

Globalization in clinical research and development has increased since the 1990s. Products approved in the United States (U.S.) and European Union (EU) include increasing numbers of research participants from low- and middle-income countries. The purposes of this quantitative correlational study were to investigate the lag time, or drug lag, between U.S. approval and the approval of selected drugs in all countries that hosted their pivotal clinical trials. The study population was limited to products approved first in the U.S. between 2006 and 2015. The health capability model and research for health justice framework were the theoretical frameworks for the study. Data were collected from public reports and websites of the U.S. Food and Drug Administration (FDA), European Medicines Agency, National Institutes of Health, local ministries of health, National Association of Securities Dealers Automated Quotations, New York Stock Exchange, the World Bank, and a subscription-based report from Springer Publications. Data were analyzed descriptively, with inferential statistics performed via Wilcoxon and chi-square tests. Independent variables were FDA approval year, drug indication, FDA review type, orphan indication, host country World Bank income category, sponsor market capitalization, and sponsor headquarters country. The dependent variable was drug lag, in months. The U.S. to EU drug lag was significantly shorter than U.S. to last host country drug lag. Lower host country income was also associated with longer drug lag. Reducing drug lag may create justice for research participants, improve health outcomes, and yield positive social changes.

The objective of this study was to determine the patterns of regulatory noncompliance, as identified by the U.S. Food and Drug Administration (FDA), and their effects on meta-analyses. In order to achieve these objective, three studies were undertaken: analysis of citations issued by FDA Investigators at the conclusion of an inspection; analysis of regulatory actions taken by the FDA towards clinical researchers based on the observations cited by FDA Investigators; and sensitivity analysis of meta-analyses based on the Agency’s determination of research misconduct, primarily the falsification of data. FDA Investigator citations were analyzed using Chi-Square analysis based on geographic location of the inspection, type of inspection, and type of violation. Temporal changes in the number of inspections and the violations cited were analyzed using bivariate Poisson regression models. Bonferroni correction was employed for temporal changes across the time period analyzed. Regulatory actions taken by the agency were analyzed via Chi-Square or Fisher’s exact test based on changes identified in previous publications, temporal changes, and differences between regulatory action types. Sensitivity analysis of meta-analyses identified through a systematic review were assessed both qualitatively and quantitatively for the effects of including publications of apixaban trials with significant FDA regulatory action, i.e. the comparison of odds ratio point estimate, upper and lower 95% confidence interval, both before and after consideration of falsified data. Under the FDA’s Bioresearch Monitoring program from 2007-2015, the number of inspections increased, but the rate of citation issuance per inspection decreased. One third of the violations were related to adherence to investigational procedures followed by informed consent violations and violations involving study records. During this same time period, 194 clinical researchers received a regulatory action based on FDA’s review of inspection results. Since 2007, rates of significant deviations had decreased. Lack of researcher supervision and submission of false information were cited more frequently for disqualification proceedings. A systematic review found 99 statistical analyses from 22 different meta-analyses available for sensitivity analyses. Nearly one-third resulted in a change in the conclusions reported in the originally published statistical analyses. In approximately the last decade, the number of violations cited during inspections under the Bioresearch Monitoring program has decreased; however, significant improvements can continue to be made regarding adherence to study procedures, the consenting of human subjects, and creation of adequate and accurate study documentation. Disqualification of clinical researchers is more likely to occur when researchers fail to supervise a clinical trial or false information is submitted to the FDA. Falsified data can make its way into the exploding field of meta-analyses, a study method that provides a concise and compelling method for the dissemination of medical intervention knowledge; however, this method can be highly unstable and can provide biased results. A robust sensitivity analysis that considers data quality from available sources can help ensure calculations of the best estimates.

This thesis is about primary care medicine in the United States today. Specifically, I look into primary care providers’ experiences working with patients in the context of the public’s current access to extensive health and medical information online. In this thesis, I discuss and analyze my conversations with physicians, nurse practitioners, and a physicians’ assistant about their objectives in primary care, the challenges they face, and their perceptions of patients’ ability to seek out information on their own. I explore providers’ educational emphasis in primary care consultations, and argue that this focus on education informs their views of patients’ independent research and involvement in care. I further argue that regardless of my informants’ enthusiasm about patient involvement and the merits of patient-education, these providers still hold and express a strong authority over medical knowledge and decisions. Thus in looking at the influence of what could be seen as a democratization of medical knowledge through public access and the Internet, it seems that the limitations of such access are still great in U.S. medical practice.

Análisis comparativo de las legislaciones autonómicas del Estado Español. Analizando las diferencias y sus posibles consecuencias, para formular una reflexión general a la vista de experiencias previas en otros países. Se proponen estrategias para llevar a cabo procesos de planificación anticipada y no únicamente documentos de Instrucciones previas con escasa utilidad práctica y con una finalidad básica de "autonomía defensiva". / Comparative analysis of autonomics laws Spanish's state. Analyzing the differences and their possible consequences to formulate a general reflection around previous experiences in others countries. It proposes strategies to carry out processes of advance care planning and not only advance directives documents with little practical utility and with the basic purpose of "defensive autonomy".

Thesis (doctoral)--Universität Münster (Westfalen), 1999. / Includes bibliographical references (p. [453]-469).

Introduction et problématiques: Les politiques et choix des produits plasmatiques (PP) ou recombinants (PR) en hémophilie divergent selon les pays en dépit de recommandations internationales consensuelles. A la différence d'autres pays, la politique française en ce sens ne fait aucune priorité de choix entre les PP versus les PR en dépit de l'avènement de variante (v) de la maladie de Creutzfeldt-Jakob (MCJ) dont le risque transfusionnel affecté à ces premiers est jugé être infinitésimal. L'adhésion des soignants et des patients à cette politique ainsi que les répercussions psychologiques des retraits de lots de PP pour le risque de vMCJ sur ces derniers, sont inconnues et suscitent des questions éthiques. Méthodologie: Des enquêtes mono et multicentriques ont été menées auprès de patients et médecins français afin d'évaluer leurs sentiments envers la politique de maintien sans restriction des PP et celle de leurs procédures de retrait de lots. Une discussion des problématiques éthiques inhérentes est conduite à partir des rapports des expertises scientifiques et de nos propres données. Résultats: L'analyse des politiques et choix des PP versus PR en hémophilie a permis d'identifier un modèle français aux côtés des trois modèles nord-américain, britannique et européen. Ce premier modèle apparaît être le moins astreignant alors que la France pointe à la haute deuxième place de la prévalence mondiale de la vMCJ après le Royaume Uni qui a tout simplement banni la prescription des PP pour les hémophiles, à la faveur des PR dénués de ce risque. Nous avons identifié nombre de tensions dans la prise en charge des patients et dans la gestion des risques de ces produits en France. Celles-ci sont principalement le fait de quatre problématiques qui correspondent à des paradoxes français de la politique de gestion de risque de ces produits, notamment: 1) multiplication injustifiée des procédures de retrait de lot de PP, essentiellement en rapport avec les formes sporadiques de la MCJ pourtant non transmissibles par ce biais. 2) absence de formalisation précise de l'organisation des procédures de retrait de lot dont les sources, les méthodes, les moyens et les délais de contact des médecins et leur relais aux patients sont divers et variés, ce qui témoigne d'une certaine improvisation et d'un cafouillage dans ce processus. 3) maintien sans restriction d'indication ni de source des PP. 4) information systématique traumatisante à posteriori des patients à l'occasion des retraits de lots pour ce risque très infime, au lieu d'une approche au cas par cas. Les problématiques éthiques induites sont: traumatisme psychologique rémanent des patients et leur famille à l'occasion de l'information, mal conduite et mal comprise, du risque de la vMCJ lors des procédures de retrait de lots de PP conduisant à leur switch massif pour des PR; inefficacité de ces procédures à éliminer les lots incriminés car souvent déjà consommés; diminution drastique, voire bannissement de la prescription des PP; vécu difficile et désapprobation majoritaire des médecins de la politique du maintien sans restriction des PP et des procédures de retrait de lot; faible respect des procédures de retrait de lots, appliquées de façon confuse et inégale; crise de confiance des patients et médecins envers cette politique; sentiments de conflits d'intérêts des autorités politiques en rapport avec un protectionnisme supposé de l'industrie nationale de fabrication des PP en l'absence de motifs solides à leur maintien sans restriction à des indications précises. Conclusion: Un recadrage institutionnel de procédures de retrait de PP en France apparait nécessaire, celles-ci étant majoritairement injustifiées car relatives aux formes sporadiques de la MCJ. La limitation de l'usage des PP à des indications spécifiques nécessite d'être discutée à l'heure de la grande disponibilité des PR. De larges enquêtes et réflexions aideraient aux futures orientations de la politique nationale. / Introduction and issues: The policy and local choices of plasmatic (PP) or recombinant products (RP) in hemophilia vary according to the country, despite consensus international recommendations. In contrast to other countries, French policy in this context gives no priority in the choice between plasmatic and recombinant ones, despite the appearance of variant Creutzeldt-Jakob disease (vCJD) involving risks in transfusions, albeit miniscule, in the former. Caregivers and patient adherence to this policy and its likely psychological impact on them, are unknown and raise ethical questions. Methodology: Single- and multi-site surveys of French doctors and patients were carried out to evaluate their feelings about the French policy of unrestricted continued use of plasmatic products and their procedures of batch recall. A discussion of inherent ethical problems is conducted, based on reports of scientific expertise and our own data. Results: This analysis allowed a French model to be defined and compared to the North American, British, and European ones. This French model seems to be the least strict in terms of the use of PP, while France is in second place in terms of the worldwide prevalence of vCJD, just after U.K who have simply banned the prescription of these first products for hemophiliacs in favor of RP, which are risk-free. We identified many ethical tensions in the management of patients and in risk management of these products in France. These are mainly due to four issues that correspond to the paradoxes of French policy of hemophilia product risk management, including: 1) unjustified multiplication of recall procedures concerning batches of PP, primarily those related to sporadic forms of CJD even though incommunicable through it; 2) lack of accurate formalization concerning the organization of batch removal procedures, the sources, methods, means and time of contact for physicians and their patients that are very varied, reflecting some improvisations and a mess in the process; 3) maintaining of unrestricted indication and source of PP; 4) systematic retrospectively traumatic information for patients, especially during the batch recalls for this very small risk, rather than a case-by-case basis. The induced ethical issues are : residual psychological trauma for patients and their families on the occasion of information, poorly managed and poorly understood, the risk of vMCJ during batches removal procedures of PP leading to their massive switch RP ; ineffectiveness of these procedures to remove incriminated batches since they are often consumed; drastic reduction or even banishment of the prescription of PP; difficult experience and majority disapproval of physicians maintaining unrestricted PP and batch removal procedures; low respect for batch removal procedures, applied unevenly; crisis of confidence of patients and physicians concerning this policy; feelings of conflict of interest from political authorities in connection with an alleged protectionism of the domestic industry manufacturing PP in the absence of strong reasons to their retention without restriction to specific indications. Conclusion: An institutional reframing of PP recall in France appears to be necessary, these being mainly unjustified since relative to sporadic CJD forms. Restrictions on the use of PP at specific directions need to be discussed at this time of high availability of RP. Extensive surveys would help the future direction of national policy.

Gydytojo ir paciento santykiai visais laikais buvo medicinos dėmesio centre. Naujų technologijų taikymas leido gydytojui turėti objektyviais duomenimis pagrįstą paciento sveikatos būklės vaizdą, todėl gydytojas mažiau linkęs gilintis į subjektyvius paciento išgyvenimus. Gydytojų-pacient�� santykių etinių problemų sprendimas neįmanomas be valstybės ekonominių, politinių ir teisinių veiksmų. Darbo tikslas. Įvertinti Prienų PSPC gydytojų ir pacientų santykių etinius aspektus pacientų požiūriu. Tyrimo metodai. 2007m. sausio – vasario mėn. buvo atlikta Prienų PSPC pacientų, kurie apsilankė pas BPG (n=304), anketinė apklausa. Duomenų analizė atlikta naudojant statistinės analizės paketą SPSS (9,0). Dviejų požymių priklausomumas buvo tiriamas naudojant χ² kriterijų. Nulinė hipotezė buvo atmetama, kai p<0,05. Rezultatai. Didžioji vyriausios bei jauniausios amžiaus grupės, turinčių pradinį bei aukštąjį išsimokslinimą bei dideles pajamas pacientų dalis buvo patenkinti gydytojo bendravimu su jais bei palankiai vertina gydytojo ir paciento santykių administravim����, o nepasitenkinimą nurodė vidutinio amžiaus, vidurinio išsimokslinimo, mažas pajamas turintys respondentai. Labiausiai pritaria teisiniams klausimams vyriausios bei jauniausios amžiaus grupės miesto respondentai, turintys dideles pajamas. Nepatenkinti teisiniais santykiais vidutinio vyresniojo amžiaus mažų pajamų kaimo pacientai. Išvados. Pacientai patenkinti juos aptarnaujančio šeimos (BPG) gydytojo bendražmogiškomis... [toliau žr. visą tekstą] / The relationship between a physician and a patient has always been a centre of medical attention. Application of modern technologies enables a physician to receive a clear picture of a patient’s health rather than become concerned about his/her personal feelings. The solution of physician–patient ethical problems is not possible without state economical, political and legal measures. Aim of the study. To assess the ethical aspects of physician-patient relationship of Prienai Primary Health Care Centre from the patients’ attitude. Methods. In January – February 2007, a survey was conducted in order to receive the opinion from Prienai district residents, who visited a GP (n=304). Statistical analysis package SPSS (9.0) was used to analyse the data. Dependence of two symptoms was researched with of the Chi-Square test (χ²). Zero hypothesis was rejected, when p<0,05. Results. A greater part of elderly and young people who have a higher or primary education and high income were satisfied with physician–patient relationship and gave favourable assessment of the administration of the relationship. Middle-aged people who have secondary education and low income were most dissatisfied with the above mentioned. Most favourable opinion about the legal matters was provided by the oldest and youngest group of the city respondents who have high income, whereas middle-aged senior country people who have low income were dissatisfied with the legal matters. Conclusions. The patients were... [to full text]

Zugl.: Würzburg, Univ., Diss., 2006

Thesis (M.Phil.)--University of Hong Kong, 1999. / Includes bibliographical references (leaves 212-241) Also available in print.