Legal and ethical issues in research.

PubMed

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-09-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

Ethically-based clinical decision-making in physical therapy: process and issues.

PubMed

Finch, Elspeth; Geddes, E Lynne; Larin, Hélène

2005-01-01

The identification and consideration of relevant ethical issues in clinical decision-making, and the education of health care professionals (HCPs) in these skills are key factors in providing quality health care. This qualitative study explores the way in which physical therapists (PTs) integrate ethical issues into clinical practice decisions and identifies ethical themes used by PTs. A purposive sample of eight PTs was asked to describe a recent ethically-based clinical decision. Transcribed interviews were coded and themes identified related to the following categories: 1) the integration of ethical issues in the clinical decision-making process, 2) patient welfare, 3) professional ethos of the PT, and 4) health care economics and business practices. Participants readily described clinical situations involving ethical issues but rarely identified specific conflicting ethical issues in their description. Ethical dilemmas were more frequently resolved when there were fewer emotional sequelae associated with the dilemma, and the PT had a clear understanding of professional ethos, valued patient autonomy, and explored a variety of alternative actions before implementing one. HCP students need to develop a clear professional ethos and an increased understanding of the economic factors that will present ethical issues in practice.

Comparsion analysis of data mining models applied to clinical research in traditional Chinese medicine.

PubMed

Zhao, Yufeng; Xie, Qi; He, Liyun; Liu, Baoyan; Li, Kun; Zhang, Xiang; Bai, Wenjing; Luo, Lin; Jing, Xianghong; Huo, Ruili

2014-10-01

To help researchers selecting appropriate data mining models to provide better evidence for the clinical practice of Traditional Chinese Medicine (TCM) diagnosis and therapy. Clinical issues based on data mining models were comprehensively summarized from four significant elements of the clinical studies: symptoms, symptom patterns, herbs, and efficacy. Existing problems were further generalized to determine the relevant factors of the performance of data mining models, e.g. data type, samples, parameters, variable labels. Combining these relevant factors, the TCM clinical data features were compared with regards to statistical characters and informatics properties. Data models were compared simultaneously from the view of applied conditions and suitable scopes. The main application problems were the inconsistent data type and the small samples for the used data mining models, which caused the inappropriate results, even the mistake results. These features, i.e. advantages, disadvantages, satisfied data types, tasks of data mining, and the TCM issues, were summarized and compared. By aiming at the special features of different data mining models, the clinical doctors could select the suitable data mining models to resolve the TCM problem.

Clinical Considerations in Treating BDSM Practitioners: A Review.

PubMed

Dunkley, Cara R; Brotto, Lori A

2018-03-15

BDSM is an overlapping acronym referring to the practices of bondage and discipline, dominance and submission, and sadism and masochism. This article reviews the psychological literature on BDSM practitioners and discusses issues concerning BDSM that are relevant to clinicians and sexual health-care providers. The literature concerning the psychological health of BDSM practitioners and clinical issues in treating BDSM practitioners was exhaustively reviewed. BDSM practitioners differ minimally from the general population in terms of psychopathology. Six clinical considerations emerged: ignoring versus considering BDSM; countertransference; nondisclosure; cultural competence; closer relationship dynamics; BDSM, abuse, and pathology.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

PubMed

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2016-01-01

When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review

PubMed Central

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2016-01-01

Background When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. Aim To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. Method A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. Results The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. Conclusions The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure. PMID:26938863

The early development phases of a European Organisation for Research and Treatment of Cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction.

PubMed

Thomson, H J; Winters, Z E; Brandberg, Y; Didier, F; Blazeby, J M; Mills, J

2013-03-01

A comprehensive evaluation of breast reconstruction (BRR) surgery includes measurement of patient reported outcomes (PROs). There is, however, a lack of validated BRR-specific PRO measures (PROMs) that adequately assess relevant issues. This study is developing a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire/module specific for PROs in BRR to supplement the cancer-core and breast cancer EORTC questionnaires, respectively: the QLQ-C30 and QLQ-BR23. Phases I and II of questionnaire development followed EORTC guidelines including a systematic literature review to identify all potential 'issues' (concepts relevant to PROs) and semi-structured interviews with 89 patients and 9 European multi-disciplinary health care professionals (HCPs) (Sweden, Italy and the United Kingdom [UK]). Interviewers asked participants the 'relevance' of outcomes identified in the literature and captured additional 'issues' of importance. The literature search and interviews of patients and HCPs yielded 69 issues relating to BRR operationalised into 31 provisional items (single questions) for the module, which was conceptualised to contain five scales: treatment/surgery related symptoms (affecting the shoulder, arm and reconstructed breast), body image, sexuality, cosmetic outcomes (pertaining to three areas: breast, donor site and nipple) and overall satisfaction. The provisional development of the EORTC BRR module has 31 items addressing issues of importance to patients as well as HCPs. Further international testing is underway as a UK National Cancer Research Network trial to ensure that this PROM will be psychometrically and clinically robust and applicable for use in clinical trials, cohort studies, national audit and clinical practice. Copyright © 2012 Elsevier Ltd. All rights reserved.

Introduction to the Special Issue on Neuropsychology Practices in Integrated Care Teams.

PubMed

Festa, Joanne R

2018-05-01

This special issue on neuropsychology practices in integrated healthcare teams demonstrates how neuropsychologists have transformed their practices in an evolving healthcare landscape. These contributions are an overview of the many ways in which neuropsychologists function in integrated care teams. The experiences of integrated neuropsychologists serve as a model for those seeking new practice opportunities by providing highly practical, clinically relevant information. Included in this volume are articles on education and reimbursement issues, information about clinical practices that address diagnostic issues, prognostics and clinical management, as well as surgical treatment planning and outcome prediction. Authors highlight the value of their services, their contribution to improving team and patient communication, as well as the biopsychosocial understanding of the patient. Several unexpected challenges are detailed among the pearls and pitfalls of these practices.

Prescription Drug Monitoring Programs: Ethical Issues in the Emergency Department.

PubMed

Marco, Catherine A; Venkat, Arvind; Baker, Eileen F; Jesus, John E; Geiderman, Joel M

2016-11-01

Prescription drug monitoring programs are statewide databases available to clinicians to track prescriptions of controlled medications. These programs may provide valuable information to assess the history and use of controlled substances and contribute to clinical decisionmaking in the emergency department (ED). The widespread availability of the programs raises important ethical issues about beneficence, nonmaleficence, respect for persons, justice, confidentiality, veracity, and physician autonomy. In this article, we review the ethical issues surrounding prescription drug monitoring programs and how those issues might be addressed to ensure the proper application of this tool in the ED. Clinical decisionmaking in regard to the appropriate use of opioids and other controlled substances is complex and should take into account all relevant clinical factors, including age, sex, clinical condition, medical history, medication history and potential drug-drug interactions, history of addiction or diversion, and disease state. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Psychosis in a Case of Dandy-Walker Syndrome: A Case Report.

PubMed

Dawra, Ripu Daman; Karia, Sagar; Shah, Nilesh; Desousa, Avinash

2017-05-01

Dandy Walker Syndrome (DWS) is a congenital malformation with brain abnormalities, intellectual disabilities, epilepsy and visible structural changes in particular brain structures. We present here a case of psychosis in an 18-year-old male with DWS, epilepsy and intellectual disability. The purpose of this paper is to discuss the clinically relevant issues, psychopharmacological issues, neuropsychiatric manifestations and consultation liaison issues involved.

Psychosis in a Case of Dandy-Walker Syndrome: A Case Report

PubMed Central

Dawra, Ripu Daman; Karia, Sagar; Shah, Nilesh

2017-01-01

Dandy Walker Syndrome (DWS) is a congenital malformation with brain abnormalities, intellectual disabilities, epilepsy and visible structural changes in particular brain structures. We present here a case of psychosis in an 18-year-old male with DWS, epilepsy and intellectual disability. The purpose of this paper is to discuss the clinically relevant issues, psychopharmacological issues, neuropsychiatric manifestations and consultation liaison issues involved. PMID:28658885

Clinical Relevance Versus Statistical Significance: Aman and Colleagues Respond to Editorial.

PubMed

Aman, Michael G; Arnold, L Eugene; Barterian, Justin A

2018-05-01

We would like to respond to the thought-provoking editorial by Dr. Jon McClellan 1 regarding our article "Clinical Implications from the Treatment of Severe Childhood Aggression (TOSCA) Study: A Re-Analysis and Integration of Findings," published in the December 2017 issue of JAACAP. 2 We address some issues on which we partially disagree, and comment on convergence of opinion. Copyright © 2018 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Regulatory issues in accreditation of toxicology laboratories.

PubMed

Bissell, Michael G

2012-09-01

Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

Impact of a novel teaching method based on feedback, activity, individuality and relevance on students' learning.

PubMed

Edafe, Ovie; Brooks, William S; Laskar, Simone N; Benjamin, Miles W; Chan, Philip

2016-03-20

This study examines the perceived impact of a novel clinical teaching method based on FAIR principles (feedback, activity, individuality and relevance) on students' learning on clinical placement. This was a qualitative research study. Participants were third year and final year medical students attached to one UK vascular firm over a four-year period (N=108). Students were asked to write a reflective essay on how FAIRness approach differs from previous clinical placement, and its advantages and disadvantages. Essays were thematically analysed and globally rated (positive, negative or neutral) by two independent researchers. Over 90% of essays reported positive experiences of feedback, activity, individuality and relevance model. The model provided multifaceted feedback; active participation; longitudinal improvement; relevance to stage of learning and future goals; structured teaching; professional development; safe learning environment; consultant involvement in teaching. Students perceived preparation for tutorials to be time intensive for tutors/students; a lack of teaching on medical sciences and direct observation of performance; more than once weekly sessions would be beneficial; some issues with peer and public feedback, relevance to upcoming exam and large group sizes. Students described negative experiences of "standard" clinical teaching. Progressive teaching programmes based on the FAIRness principles, feedback, activity, individuality and relevance, could be used as a model to improve current undergraduate clinical teaching.

Legal and ethical issues in research

PubMed Central

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-01-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees. PMID:27729698

Restructuring of the jurisprudence course taught at the Canadian Memorial Chiropractic College

PubMed Central

Gleberzon, Brian J.

2010-01-01

Introduction: The process by which the jurisprudence course was restructured at the Canadian Memorial Chiropractic College is chronicled. Method: A Delphi process used to restructure the course is described, and the results of a student satisfaction survey are presented. Results: When asked “I think this material was clinically relevant,” over 81% of the 76 students who respondents strongly agreed or agreed with this statement; 100% of students agreed or strongly agreed that scope of practice; marketing, advertising and internal office promotion; record keeping; fee schedules; malpractice issues and; professional malpractice issues and negligence was clinically relevant. When asked “I think this material was taught well,” a minimum of 89% of students agreed or strongly agreed with this statement. Discussion: This is the first article published that described the process by which a jurisprudence course was developed and assessed by student survey. Summary: Based on a survey of student perceptions, restructuring of the jurisprudence course was successful in providing students with clinically relevant information in an appropriate manner. This course may serve as an important first step in development a ‘model curriculum’ for chiropractic practice and the law courses in terms of content, format and assessment strategies. PMID:20195427

Learning to consult with computers.

PubMed

Liaw, S T; Marty, J J

2001-07-01

To develop and evaluate a strategy to teach skills and issues associated with computers in the consultation. An overview lecture plus a workshop before and a workshop after practice placements, during the 10-week general practice (GP) term in the 5th year of the University of Melbourne medical course. Pre- and post-intervention study using a mix of qualitative and quantitative methods within a strategic evaluation framework. Self-reported attitudes and skills with clinical applications before, during and after the intervention. Most students had significant general computer experience but little in the medical area. They found the workshops relevant, interesting and easy to follow. The role-play approach facilitated students' learning of relevant communication and consulting skills and an appreciation of issues associated with using the information technology tools in simulated clinical situations to augment and complement their consulting skills. The workshops and exposure to GP systems were associated with an increase in the use of clinical software, more realistic expectations of existing clinical and medical record software and an understanding of the barriers to the use of computers in the consultation. The educational intervention assisted students to develop and express an understanding of the importance of consulting and communication skills in teaching and learning about medical informatics tools, hardware and software design, workplace issues and the impact of clinical computer systems on the consultation and patient care.

Swallowing in Parkinson's disease: clinical issues and management.

PubMed

Miller, Nick

2017-06-01

Changes to swallowing affect most people with Parkinson's disease (PD). Changes may not initially exercise a decisive impact, but can later pose significant threats to nutritional, hydration and respiratory health and psychosocial quality of life. This review, from a largely clinical viewpoint, outlines the nature of changes in PD and considers the issue of how many people are affected and in what ways. It outlines main approaches to assessment and management, with an emphasis on aspects relevant to PD. Dysphagia contributes to drooling in PD. The review therefore also touches on the nature and management of this condition that has its own set of health and psychosocial quality-of-life issues.

Transforming Big Data into cancer-relevant insight: An initial, multi-tier approach to assess reproducibility and relevance* | Office of Cancer Genomics

Cancer.gov

The Cancer Target Discovery and Development (CTD^2) Network was established to accelerate the transformation of "Big Data" into novel pharmacological targets, lead compounds, and biomarkers for rapid translation into improved patient outcomes. It rapidly became clear in this collaborative network that a key central issue was to define what constitutes sufficient computational or experimental evidence to support a biologically or clinically relevant finding.

Conceptual framework for behavioral and social science in HIV vaccine clinical research

PubMed Central

Lau, Chuen-Yen; Swann, Edith M.; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I.; Stansbury, James P.

2011-01-01

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance. PMID:21821083

Conceptual framework for behavioral and social science in HIV vaccine clinical research.

PubMed

Lau, Chuen-Yen; Swann, Edith M; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I; Stansbury, James P

2011-10-13

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance. Published by Elsevier Ltd.

Impact of a novel teaching method based on feedback, activity, individuality and relevance on students’ learning

PubMed Central

Brooks, William S.; Laskar, Simone N.; Benjamin, Miles W.; Chan, Philip

2016-01-01

Objectives This study examines the perceived impact of a novel clinical teaching method based on FAIR principles (feedback, activity, individuality and relevance) on students’ learning on clinical placement. Methods This was a qualitative research study. Participants were third year and final year medical students attached to one UK vascular firm over a four-year period (N=108). Students were asked to write a reflective essay on how FAIRness approach differs from previous clinical placement, and its advantages and disadvantages. Essays were thematically analysed and globally rated (positive, negative or neutral) by two independent researchers. Results Over 90% of essays reported positive experiences of feedback, activity, individuality and relevance model.  The model provided multifaceted feedback; active participation; longitudinal improvement; relevance to stage of learning and future goals; structured teaching; professional development; safe learning environment; consultant involvement in teaching. Students perceived preparation for tutorials to be time intensive for tutors/students; a lack of teaching on medical sciences and direct observation of performance; more than once weekly sessions would be beneficial; some issues with peer and public feedback, relevance to upcoming exam and large group sizes. Students described negative experiences of “standard” clinical teaching. Conclusions Progressive teaching programmes based on the FAIRness principles, feedback, activity, individuality and relevance, could be used as a model to improve current undergraduate clinical teaching. PMID:26995588

Deep and continuous palliative sedation (terminal sedation): clinical-ethical and philosophical aspects.

PubMed

Materstvedt, Lars Johan; Bosshard, Georg

2009-06-01

Terminal sedation continues to fuel debate. When confronted with a patient for whom terminal sedation is considered a possible treatment option, decision making can be difficult. In this paper we focus on the clinical-ethical issues, with an aim to provide clinicians with ways of framing the issue from an ethical point of view. In addition to the clinical-ethical issues, terminal sedation touches upon interesting and complex questions of an essentially philosophical nature. What it means to be a "person" is one such question, and is a topic that is relevant to clinical, daily practice. Accordingly, in the latter part of this paper we draw briefly on selected philosophical positions to elucidate this question. A doctor's belief of what it means to be a "person" might well affect their actions. For example, if a doctor believes terminal sedation involves the destruction of the person, they might not be willing to proceed with it.

Personal genome testing: Test characteristics to clarify the discourse on ethical, legal and societal issues

PubMed Central

2011-01-01

Background As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics. Discussion This paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the newer notion of 'personal utility.' Summary Consideration of test characteristics is essential to any valuable discourse on the ELSI of personal genome testing for multifactorial diseases. Four key characteristics of the test - targeted/non-targeted testing, analytical validity, clinical validity and clinical utility - together determine the applicability and the relevance of ELSI to specific tests. The paper identifies and discusses four areas of interest for the ELSI-debate on personal genome testing: informational problems, risks, regulatory issues, and the notion of personal utility. PMID:21672210

Effects of Client Bisexuality on Clinical Judgment: When Is Bias Most Likely to Occur?

ERIC Educational Resources Information Center

Mohr, Jonathan J.; Weiner, Jennifer L.; Chopp, Regina M.; Wong, Stephanie J.

2009-01-01

In this study, the authors investigated whether psychotherapist bias related to client bisexuality is most likely to occur with respect to judgments about stereotype-relevant clinical issues. Participants were 108 psychotherapists who read a fictitious intake report about a male client who was portrayed as heterosexual, gay, or bisexual. Client…

Interviews with children about their mental health problems: The congruence and validity of information that children report.

PubMed

Macleod, Emily; Woolford, June; Hobbs, Linda; Gross, Julien; Hayne, Harlene; Patterson, Tess

2017-04-01

To obtain a child's perspective during a mental health assessment, he or she is usually interviewed. Although researchers and clinicians generally agree that it is beneficial to hear a child's account of his or her presenting issues, there is debate about whether children provide reliable or valid clinical information during these interviews. Here, we examined whether children provide clinically and diagnostically relevant information in a clinical setting. In all, 31 children aged 5-12-years undergoing mental health assessments were asked open-ended questions about their presenting problems during a semi-structured interview. We coded the information that children reported to determine whether it was clinically relevant and could be used to diagnose their problems and to formulate and plan treatment. We also coded children's information to determine whether it was congruent with the children's presenting problems and their eventual clinical diagnoses. Most of the information that children reported was clinically relevant and included information about behaviour, affect, temporal details, thoughts, people, the environment, and the child's physical experiences. The information that children reported was also clinically valid; it was congruent with the problems that were discussed (84%) and also with the eventual diagnosis that the child received after a complete assessment (74%). We conclude that children can contribute relevant, clinically useful, valid information during clinical psychological assessments.

Ethical, legal and clinical aspects of live surgery in urology – contemporary issues and a glimpse of the future

PubMed Central

Ferician, Ovidiu Catalin; Latcu, Silviu Constantin; Pricop, Catalin; Bardan, Razvan Tiberiu

2017-01-01

Beside dry and wet lab training, simulators, video tapes, fellowships and clinical visits, live surgery has gained popularity during the last years, being an attraction point at large scientific meetings and at postgraduate courses as well. This type of surgical training raises both ethical and legal issues. Thus, there are professional societies that have banned such meetings, mainly due to safety reasons for the patient. The current article aims to identify and to discuss ethical and legal issues related to the topic, advantages, disadvantages and weak points of this emerging challenge for modern medicine, trying to analyze the issues from all relevant points of view: those of the patient, the surgeon and the session attendant. PMID:28446925

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire.

PubMed

van Leeuwen, Marieke; Husson, Olga; Alberti, Paola; Arraras, Juan Ignacio; Chinot, Olivier L; Costantini, Anna; Darlington, Anne-Sophie; Dirven, Linda; Eichler, Martin; Hammerlid, Eva B; Holzner, Bernhard; Johnson, Colin D; Kontogianni, Meropi; Kjær, Trille Kristina; Morag, Ofir; Nolte, Sandra; Nordin, Andrew; Pace, Andrea; Pinto, Monica; Polz, Katja; Ramage, John; Reijneveld, Jaap C; Serpentini, Samantha; Tomaszewski, Krzysztof A; Vassiliou, Vassilios; Verdonck-de Leeuw, Irma M; Vistad, Ingvild; Young, Teresa E; Aaronson, Neil K; van de Poll-Franse, Lonneke V

2018-06-04

The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used. We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors. We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment. Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.

An exploratory survey on the views of European tissue engineers concerning the ethical issues of tissue engineering research.

PubMed

Trommelmans, Leen; Selling, Joseph; Dierickx, Kris

2009-09-01

We present the first exploratory survey about the views of tissue engineers on the ethical issues of tissue engineering (TE), conducted among participants of a large European TE consortium. We analyzed the topics for which ethical guidance is necessary and the preferred dissemination channels, which are relevant issues and goals of clinical trials with human tissue-engineered products, and which information is to be given to trial participants. The need for comprehensive, specific ethical guidance of TE is a first key finding of this survey. Second, it becomes clear that little clarity exists on some crucial issues in the setup and conduct of clinical trials in TE. Identifying the unique features of TE and their repercussions for the ethical conduct of TE research and therapy is necessary. Third, prospective trial participants are to be informed about a wide variety of issues before taking part in the trial.

Medical and Nursing Students’ Television Viewing Habits: Potential Implications for Bioethics

PubMed Central

Czarny, Matthew J.; Faden, Ruth R.; Nolan, Marie T.; Bodensiek, Edwin; Sugarman, Jeremy

2011-01-01

Television medical dramas frequently depict the practice of medicine and bioethical issues in a strikingly realistic but sometimes inaccurate fashion. Because these shows depict medicine so vividly and are so relevant to the career interests of medical and nursing students, they may affect these students’ beliefs, attitudes, and perceptions regarding the practice of medicine and bioethical issues. We conducted a web-based survey of medical and nursing students to determine the medical drama viewing habits and impressions of bioethical issues depicted in them. More than 80% of medical and nursing students watch television medical dramas. Students with more clinical experience tended to have impressions that were more negative than those of students without clinical experience. Furthermore, viewing of television medical dramas is a social event and many students discuss the bioethical issues they observe with friends and family. Television medical dramas may stimulate students to think about and discuss bioethical issues. PMID:19085461

Prediction of tamoxifen outcome by genetic variation of CYP2D6 in post-menopausal women with early breast cancer

PubMed Central

Brauch, Hiltrud; Schwab, Matthias

2014-01-01

The question of whether genetic polymorphisms of CYP2D6 can affect treatment outcome in patients with early post-menopausal oestrogen receptor (ER)-positive breast cancer has been a matter of debate over the past few years. In this article we revisit the hypothesis of CYP2D6 being a potential tamoxifen outcome predictor and provide detailed insight into the ongoing controversy that prevented the CYP2D6 marker from being accepted by the scientific and clinical community. We summarize the available pharmacokinetic, pharmacodynamic and pharmacogenetic evidence and resolve the controversy based on the recognized methodological and statistical issues. The cumulative evidence suggests that genotyping for CYP2D6 is clinically relevant in post-menopausal women. This is important, because the clarification of this issue has the potential to resolve a clinical management question that is relevant to hundreds of thousands of women diagnosed with ER-positive breast cancer each year, who should not be denied effective endocrine therapy. PMID:24033728

Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

PubMed

Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T

2018-02-01

The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Occult Hepatitis B (OBH) in Clinical Settings

PubMed Central

Alavian, Seyed Moayed; Miri, Seyed Mohammad; Hollinger, F. Blaine; Jazayeri, Seyed Mohammad

2012-01-01

Context Occult hepatitis B (OHB), or persistent HBV DNA in patients who are hepatitis B surface antigen (HBsAg) negative, is a recently recognized entity. In an attempt to summarize the issues, this review presents an overview of the current proposed hypothesis on the clinical relevance and also updates the knowledge on the classification of OHB in different clinical settings. Evidence Acquisition OHB could be found in different population and clinical backgrounds including: viral co-infections (with either human immunodeficiency or hepatitis C viruses), HBV chronic carriers, dialysis patients, transplantation settings and certain clinical situations (named in here: special clinical settings) with no apparent distinguishable clinical parameters. Results The exact magnitude, pathogenesis, and clinical relevance of OHB are unclear. Even the possible role exerted by this cryptic infection on liver disease outcome, and hepatocellular carcinoma development remains unknown. Conclusions Monitoring of Individuals with positive anti-HBc, mass immunization programs and improvement in diagnostic tools seem to be important to control the probability of transmission of HBV through cryptic HBV infection. PMID:23087749

Clinically relevant diagnostic research in primary care: the example of B-type natriuretic peptides in the detection of heart failure.

PubMed

Kelder, Johannes C; Rutten, Frans H; Hoes, Arno W

2009-02-01

With the emergence of novel diagnostic tests, e.g. point-of-care tests, clinically relevant empirical evidence is needed to assess whether such a test should be used in daily practice. With the example of the value of B-type natriuretic peptides (BNP) in the diagnostic assessment of suspected heart failure, we will discuss the major methodological issues crucial in diagnostic research; most notably the choice of the study population and the data analysis with a multivariable approach. BNP have been studied extensively in the emergency care setting, and also several studies in the primary care are available. The usefulness of this test when applied in combination with other readily available tests is still not adequately addressed in the relevant patient domain, i.e. those who are clinically suspected of heart failure by their GP. Future diagnostic research in primary care should be targeted much more at answering the clinically relevant question 'Is it useful to add this (new) test to the other tests I usually perform, including history taking and physical examination, in patients I suspect of having a certain disease'.

Assessment of statistical significance and clinical relevance.

PubMed

Kieser, Meinhard; Friede, Tim; Gondan, Matthias

2013-05-10

In drug development, it is well accepted that a successful study will demonstrate not only a statistically significant result but also a clinically relevant effect size. Whereas standard hypothesis tests are used to demonstrate the former, it is less clear how the latter should be established. In the first part of this paper, we consider the responder analysis approach and study the performance of locally optimal rank tests when the outcome distribution is a mixture of responder and non-responder distributions. We find that these tests are quite sensitive to their planning assumptions and have therefore not really any advantage over standard tests such as the t-test and the Wilcoxon-Mann-Whitney test, which perform overall well and can be recommended for applications. In the second part, we present a new approach to the assessment of clinical relevance based on the so-called relative effect (or probabilistic index) and derive appropriate sample size formulae for the design of studies aiming at demonstrating both a statistically significant and clinically relevant effect. Referring to recent studies in multiple sclerosis, we discuss potential issues in the application of this approach. Copyright © 2012 John Wiley & Sons, Ltd.

Ethical and Clinical Considerations at the Intersection of Functional Neuroimaging and Disorders of Consciousness.

PubMed

Byram, Adrian C; Lee, Grace; Owen, Adrian M; Ribary, Urs; Stoessl, A Jon; Townson, Andrea; Illes, Judy

2016-10-01

Recent neuroimaging research on disorders of consciousness provides direct evidence of covert consciousness otherwise not detected clinically in a subset of severely brain-injured patients. These findings have motivated strategic development of binary communication paradigms, from which researchers interpret voluntary modulations in brain activity to glean information about patients' residual cognitive functions and emotions. The discovery of such responsiveness raises ethical and legal issues concerning the exercise of autonomy and capacity for decisionmaking on matters such as healthcare, involvement in research, and end of life. These advances have generated demands for access to the technology against a complex background of continued scientific advancement, questions about just allocation of healthcare resources, and unresolved legal issues. Interviews with professionals whose work is relevant to patients with disorders of consciousness reveal priorities concerning further basic research, legal and policy issues, and clinical considerations.

Important Clinical Rehabilitation Principles Unique to People with Non-traumatic Spinal Cord Dysfunction.

PubMed

New, Peter Wayne; Eriks-Hoogland, Inge; Scivoletto, Giorgio; Reeves, Ronald K; Townson, Andrea; Marshall, Ruth; Rathore, Farooq A

2017-01-01

Background: Non-traumatic spinal cord dysfunction (SCDys) is caused by a large range of heterogeneous etiologies. Although most aspects of rehabilitation for traumatic spinal cord injury and SCDys are the same, people with SCDys have some unique rehabilitation issues. Purpose: This article presents an overview of important clinical rehabilitation principles unique to SCDys. Methods: Electronic literature search conducted (January 2017) using MEDLINE and Embase (1990-2016) databases for publications regarding SCDys. The focus of the literature search was on identifying publications that present suggestions regarding the clinical rehabilitation of SCDys. Results: The electronic search of MEDLINE and Embase identified no relevant publications, and the publications included were from the authors' libraries. A number of important clinical rehabilitation principles unique to people with SCDys were identified, including classification issues, general rehabilitation issues, etiology-specific issues, and a role for the rehabilitation physician as a diagnostic clinician. The classification issues were regarding the etiology of SCDys and the International Standards for Neurological Classification of Spinal Cord Injury. The general rehabilitation issues were predicting survival, improvement, and rehabilitation outcomes; admission to spinal rehabilitation units, including selection decision issues; participation in rehabilitation; and secondary health conditions. The etiology-specific issues were for SCDys due to spinal cord degeneration, tumors, and infections. Conclusions: Although there are special considerations regarding the rehabilitation of people with SCDys, such as the potential for progression of the underlying condition, functional improvement is typically significant with adequate planning of rehabilitation programs and special attention regarding the clinical condition of patients with SCDys.

Clinical effectiveness of garlic (Allium sativum).

PubMed

Pittler, Max H; Ernst, Edzard

2007-11-01

The objective of this review is to update and assess the clinical evidence based on rigorous trials of the effectiveness of garlic (A. sativum). Systematic searches were carried out in Medline, Embase, Amed, the Cochrane Database of Systematic Reviews, Natural Standard, and the Natural Medicines Comprehensive Database (search date December 2006). Our own files, the bibliographies of relevant papers and the contents pages of all issues of the review journal FACT were searched for further studies. No language restrictions were imposed. To be included, trials were required to state that they were randomized and double blind. Systematic reviews and meta-analyses of garlic were included if based on the results of randomized, double-blind trials. The literature searches identified six relevant systematic reviews and meta-analysis and double-blind randomized trials (RCT) that were published subsequently. These relate to cancer, common cold, hypercholesterolemia, hypertension, peripheral arterial disease and pre-eclampsia. The evidence based on rigorous clinical trials of garlic is not convincing. For hypercholesterolemia, the reported effects are small and may therefore not be of clinical relevance. For reducing blood pressure, few studies are available and the reported effects are too small to be clinically meaningful. For all other conditions not enough data are available for clinical recommendations.

Understanding the Potential Interethnic Difference in Rosuvastatin Pharmacokinetics.

PubMed

Benet, Leslie Z; Wu, Hsin-Fang

2017-09-01

Here we address the potential difference in rosuvastatin pharmacokinetics in Asians vs. whites. Our prospective study, reported in this issue, shows no ethnic difference when all subjects are wild-type for OATP1B1 and BCRP. We argue that although our study may be under powered to prove no ethnic difference, and that further confirmatory study is required, the virtual clinical study analysis, also reported in this issue, does not contradict the results of our prospective clinical study and that previous retrospective analysis of clinical studies does not include enough relevant subjects to conclude that wild-type OATP1B1 and BCRP do still demonstrate ethnic differences. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Novel approaches and perspectives in allergen immunotherapy.

PubMed

Hoffmann, H J; Valovirta, E; Pfaar, O; Moingeon, P; Schmid, J M; Skaarup, S H; Cardell, L-O; Simonsen, K; Larché, M; Durham, S R; Sørensen, P

2017-07-01

In this review, we report on relevant current topics in allergen immunotherapy (AIT) which were broadly discussed during the first Aarhus Immunotherapy Symposium (Aarhus, Denmark) in December 2015 by leading clinicians, scientists and industry representatives in the field. The aim of this symposium was to highlight AIT-related aspects of public health, clinical efficacy evaluation, mechanisms, development of new biomarkers and an overview of novel therapeutic approaches. Allergy is a public health issue of high socioeconomic relevance, and development of evidence-based action plans to address allergy as a public health issue ought to be on national and regional agendas. The underlying mechanisms are in the focus of current research that lays the ground for innovative therapies. Standardization and harmonization of clinical endpoints in AIT trials as well as current knowledge about potential biomarkers have substantiated proof of effectiveness of this disease-modifying therapeutic option. Novel treatments such as peptide immunotherapy, intralymphatic immunotherapy and use of recombinant allergens herald a new age in which AIT may address treatment of allergy as a public health issue by reaching a large fraction of patients. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The role of the speech-language pathologist in identifying and treating children with auditory processing disorder.

PubMed

Richard, Gail J

2011-07-01

A summary of issues regarding auditory processing disorder (APD) is presented, including some of the remaining questions and challenges raised by the articles included in the clinical forum. Evolution of APD as a diagnostic entity within audiology and speech-language pathology is reviewed. A summary of treatment efficacy results and issues is provided, as well as the continuing dilemma for speech-language pathologists (SLPs) charged with providing treatment for referred APD clients. The role of the SLP in diagnosing and treating APD remains under discussion, despite lack of efficacy data supporting auditory intervention and questions regarding the clinical relevance and validity of APD.

How to write a surgical clinical research protocol: literature review and practical guide.

PubMed

Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

2014-02-01

The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

42 CFR 426.440 - Evidence.

Code of Federal Regulations, 2012 CFR

2012-10-01

... testimony of expert witnesses on scientific and clinical issues, rebuttal witnesses, and other relevant... party to the proceeding, or the reports will be excluded from the record. (f) Except as set forth in... other evidence offered or taken for the record are open to examination by all parties. ...

42 CFR 426.440 - Evidence.

Code of Federal Regulations, 2014 CFR

2014-10-01

... testimony of expert witnesses on scientific and clinical issues, rebuttal witnesses, and other relevant... party to the proceeding, or the reports will be excluded from the record. (f) Except as set forth in... other evidence offered or taken for the record are open to examination by all parties. ...

42 CFR 426.440 - Evidence.

Code of Federal Regulations, 2010 CFR

2010-10-01

... on scientific and clinical issues, rebuttal witnesses, and other relevant evidence. The ALJ may... proceeding, or the reports will be excluded from the record. (f) Except as set forth in paragraph (c) of this... offered or taken for the record are open to examination by all parties. ...

Online Counseling: New Entity, New Challenges

ERIC Educational Resources Information Center

Barnett, Jeffrey E.

2005-01-01

Mallen, Vogel, and colleagues explore the developing field of online counseling from the unique perspective of counseling psychology. They examine the body of available research and relevant clinical, ethical, legal, and practical issues and make recommendations for counseling psychologists who desire to participate in online counseling. This…

The Role of Emotion in Psychological Therapy

PubMed Central

Ehrenreich, Jill T.; Fairholme, Christopher P.; Buzzella, Brian A.; Ellard, Kristen K.; Barlow, David H.

2008-01-01

This Special Issue of Clinical Psychology: Science and Practice provides a series of articles detailing efforts to consider the concepts of emotion and emotion regulation in relation to clinical assessment and psychopathology intervention efforts across the lifespan. In our commentary, we review some common themes and challenges presented in these articles to move forward the discussion of emotion’s role in psychological therapy. We discuss efforts to conceptualize the role of context in defining emotion concepts and maximizing the relevancy of such concepts to treatment. We review the importance of imbuing efforts to develop emotion-focused treatments with emphases on positive, as well as negative, emotions and flexibility in the expression of these emotions. We also highlight the relevance of a lifespan developmental approach to the accurate use of emotion and emotion regulation concepts within treatment. Finally, we discuss the application of these issues to our own treatment development and evaluation efforts regarding a unified approach to the treatment of emotional disorders in adults and adolescents. PMID:18843381

CURRENT CONCEPTS AND TREATMENT OF PATELLOFEMORAL COMPRESSIVE ISSUES.

PubMed

Mullaney, Michael J; Fukunaga, Takumi

2016-12-01

Patellofemoral disorders, commonly encountered in sports and orthopedic rehabilitation settings, may result from dysfunction in patellofemoral joint compression. Osseous and soft tissue factors, as well as the mechanical interaction of the two, contribute to increased patellofemoral compression and pain. Treatment of patellofemoral compressive issues is based on identification of contributory impairments. Use of reliable tests and measures is essential in detecting impairments in hip flexor, quadriceps, iliotibial band, hamstrings, and gastrocnemius flexibility, as well as in joint mobility, myofascial restrictions, and proximal muscle weakness. Once relevant impairments are identified, a combination of manual techniques, instrument-assisted methods, and therapeutic exercises are used to address the impairments and promote functional improvements. The purpose of this clinical commentary is to describe the clinical presentation, contributory considerations, and interventions to address patellofemoral joint compressive issues.

CURRENT CONCEPTS AND TREATMENT OF PATELLOFEMORAL COMPRESSIVE ISSUES

PubMed Central

Fukunaga, Takumi

2016-01-01

Patellofemoral disorders, commonly encountered in sports and orthopedic rehabilitation settings, may result from dysfunction in patellofemoral joint compression. Osseous and soft tissue factors, as well as the mechanical interaction of the two, contribute to increased patellofemoral compression and pain. Treatment of patellofemoral compressive issues is based on identification of contributory impairments. Use of reliable tests and measures is essential in detecting impairments in hip flexor, quadriceps, iliotibial band, hamstrings, and gastrocnemius flexibility, as well as in joint mobility, myofascial restrictions, and proximal muscle weakness. Once relevant impairments are identified, a combination of manual techniques, instrument-assisted methods, and therapeutic exercises are used to address the impairments and promote functional improvements. The purpose of this clinical commentary is to describe the clinical presentation, contributory considerations, and interventions to address patellofemoral joint compressive issues. PMID:27904792

Placing wireless tablets in clinical settings for patient education.

PubMed

Stribling, Judy C; Richardson, Joshua E

2016-04-01

The authors explored the feasibility and possible benefit of tablet-based educational materials for patients in clinic waiting areas. We distributed eight tablets preloaded with diagnosis-relevant information in two clinic waiting areas. Patients were surveyed about satisfaction, usability, and effects on learning. Technical issues were resolved. Thirty-seven of forty patients completed the survey. On average, the patients were satisfied in all categories. Placing tablet-based educational materials in clinic waiting areas is relatively easy to implement. Patients using tablets reported satisfaction across three domains: usability, education, and satisfaction.

Conducting Clinical Research Using Crowdsourced Convenience Samples.

PubMed

Chandler, Jesse; Shapiro, Danielle

2016-01-01

Crowdsourcing has had a dramatic impact on the speed and scale at which scientific research can be conducted. Clinical scientists have particularly benefited from readily available research study participants and streamlined recruiting and payment systems afforded by Amazon Mechanical Turk (MTurk), a popular labor market for crowdsourcing workers. MTurk has been used in this capacity for more than five years. The popularity and novelty of the platform have spurred numerous methodological investigations, making it the most studied nonprobability sample available to researchers. This article summarizes what is known about MTurk sample composition and data quality with an emphasis on findings relevant to clinical psychological research. It then addresses methodological issues with using MTurk--many of which are common to other nonprobability samples but unfamiliar to clinical science researchers--and suggests concrete steps to avoid these issues or minimize their impact.

Searching for Clinically Relevant Biomarkers in Geriatric Oncology.

PubMed

Katsila, Theodora; Patrinos, George P; Kardamakis, Dimitrios

2018-01-01

Ageing, which is associated with a progressive decline and functional deterioration in multiple organ systems, is highly heterogeneous, both inter- and intraindividually. For this, tailored-made theranostics and optimum patient stratification become fundamental, when decision-making in elderly patients is considered. In particular, when cancer incidence and cancer-related mortality and morbidity are taken into account, elderly patient care is a public health concern. In this review, we focus on oncogeriatrics and highlight current opportunities and challenges with an emphasis on the unmet need of clinically relevant biomarkers in elderly cancer patients. We performed a literature search on PubMed and Scopus databases for articles published in English between 2000 and 2017 coupled to text mining and analysis. Considering the top insights, we derived from our literature analysis that information knowledge needs to turn into knowledge growth in oncogeriatrics towards clinically relevant biomarkers, cost-effective practices, updated educational schemes for health professionals (in particular, geriatricians and oncologists), and awareness of ethical issues. We conclude with an interdisciplinary call to omics, geriatricians, oncologists, informatics, and policy-makers communities that Big Data should be translated into decision-making in the clinic.

Euthanasia: an overview and the jewish perspective.

PubMed

Gesundheit, Benjamin; Steinberg, Avraham; Glick, Shimon; Or, Reuven; Jotkovitz, Alan

2006-10-01

End-of-life care poses fundamental ethical problems to clinicians. Defining euthanasia is a difficult and complex task, which causes confusion in its practical clinical application. Over the course of history, abuse of the term has led to medical atrocities. Familiarity with the relevant bioethical issues and the development of practical guidelines might improve clinical performance. To define philosophical concepts, to present historical events, to discuss the relevant attitudes in modern bioethics and law that may be helpful in elaborating practical guidelines for clinicians regarding euthanasia and end-of-life care. Concepts found in the classic sources of Jewish tradition might shed additional light on the issue and help clinicians in their decision-making process. An historical overview defines the concepts of active versus passive euthanasia, physician-assisted suicide and related terms. Positions found in classical Jewish literature are presented and analyzed with their later interpretations. The relevance and application in modern clinical medicine of both the general and Jewish approaches are discussed. The overview of current bioethical concepts demonstrates the variety of approaches in western culture and legal systems. Philosophically and conceptually, there is a crucial distinction between active and passive euthanasia. The legitimacy of active euthanasia has been the subject of major controversy in recent times in various countries and religious traditions. The historical overview and the literature review demonstrate the need to provide clearer definitions of the concepts relating to euthanasia, for in the past the term has led to major confusion and uncontrolled abuse. Bioethical topics should, therefore, be included in medical training and continuing education. There are major debates and controversies regarding the current clinical and legal approaches. We trust that classical Jewish sources might contribute to the establishment of clinical definitions, meaningful approaches and practical guidelines for clinicians.

Methodological and Clinical Issues in Studies of the Performance of Emotionally Disturbed Children and Adolescents on Abbreviated Forms of the WISC-R: A Review.

ERIC Educational Resources Information Center

Zimet, Sara G.; Adler, Shoshana Shapiro

1990-01-01

Reviews research from 1974 to 1988 that suggests there is promise in valid and reliable use of a short form of the Wechsler Intelligence Scale for Children as a means of obtaining clinically relevant information and as an emergency screening device with children with serious emotional disorders. Discusses situations in which children should…

Remote Patient Management in Automated Peritoneal Dialysis: A Promising New Tool.

PubMed

Drepper, Valérie Jotterand; Martin, Pierre-Yves; Chopard, Catherine Stoermann; Sloand, James A

2018-01-01

Remote patient management (RPM) has the potential to help clinicians detect early issues, allowing intervention prior to development of more significant problems. A 23-year-old end-stage kidney disease patient required urgent start of renal replacement therapy. A newly available automated peritoneal dialysis (APD) RPM system with cloud-based connectivity was implemented in her care. Pre-defined RPM threshold parameters were set to identify clinically relevant issues. Red flag dashboard alerts heralded prolonged drain times leading to clinical evaluation with subsequent diagnosis of and surgical repositioning for catheter displacement, although it took several days for newly-RPM-exposed staff to recognize this issue. Post-PD catheter repositioning, drain times were again normal as indicated by disappearance of flag alerts and unremarkable cycle volume profiles. Identification of < 90% adherence to prescribed PD therapy was then documented with the RPM system, alerting the clinical staff to address this important issue given its association with significant negative clinical outcomes. Healthcare providers face a "learning curve" to effect optimal utilization of the RPM tool. Larger scale observational studies will determine the impact of RPM on APD technique survival and resource utilization. Copyright © 2018 International Society for Peritoneal Dialysis.

Stem cells in clinical practice: applications and warnings.

PubMed

Lodi, Daniele; Iannitti, Tommaso; Palmieri, Beniamino

2011-01-17

Stem cells are a relevant source of information about cellular differentiation, molecular processes and tissue homeostasis, but also one of the most putative biological tools to treat degenerative diseases. This review focuses on human stem cells clinical and experimental applications. Our aim is to take a correct view of the available stem cell subtypes and their rational use in the medical area, with a specific focus on their therapeutic benefits and side effects. We have reviewed the main clinical trials dividing them basing on their clinical applications, and taking into account the ethical issue associated with the stem cell therapy. We have searched Pubmed/Medline for clinical trials, involving the use of human stem cells, using the key words "stem cells" combined with the key words "transplantation", "pathology", "guidelines", "properties" and "risks". All the relevant clinical trials have been included. The results have been divided into different categories, basing on the way stem cells have been employed in different pathological conditions.

"Let Me Keep My Dead Husband's Sperm": Ethical Issues in Posthumous Reproduction.

PubMed

Panagiotopoulou, Nikoletta; Karavolos, Stamatios

2015-01-01

The feasibility of posthumous reproduction when the surviving partner is female has brought to light many ethical, moral, social, and legal issues. This review aims to summarize these issues and to assist clinicians who may be faced with such requests. A question list, used for health technologies assessment, was utilized in a question-answer approach as the review methodology. Of the 1,208 publications identified through a comprehensive literature search in biomedical, psychological, and ethical databases, 31 articles included arguments related to one or more questions from the predefined question set. Key stakeholders identified include the deceased, the requesting party, the resultant child, the physician, and society. Key ethical issues relevant to posthumous reproduction include the four traditional pillars of medical ethics--autonomy, beneficence, nonmaleficence, justice--as well as the stakeholders' rights and sociocultural attitudes. The ethical framework formulated by these issues has been incorporated in a clinical ethics decision-making tool that could prove useful to clinicians and decision makers. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Imaging opioid analgesia in the human brain and its potential relevance for understanding opioid use in chronic pain

PubMed Central

Lee, Michael C.; Wanigasekera, Vishvarani; Tracey, Irene

2014-01-01

Opioids play an important role for the management of acute pain and in palliative care. The role of long-term opioid therapy in chronic non-malignant pain remains unclear and is the focus of much clinical research. There are concerns regarding analgesic tolerance, paradoxical pain and issues with dependence that can occur with chronic opioid use in the susceptible patient. In this review, we discuss how far human neuroimaging research has come in providing a mechanistic understanding of pain relief provided by opioids, and suggest avenues for further studies that are relevant to the management of chronic pain with opioids. This article is part of the Special Issue Section entitled ‘Neuroimaging in Neuropharmacology’. PMID:23891639

Murdering while Asleep: Clinical and Forensic Issues.

ERIC Educational Resources Information Center

Gilmore, John Vaughn

On the basis of the relevant research literature, this article discusses adult sleepwalking disorders, and focuses particularly on the documented cases of violence occurring during sleepwalking. Important diagnostic elements are reviewed, including family history, age of onset, gender, stages of sleep, impairments in memory and judgment, automatic…

Coping and Adaptation: An Annotated Bibliography and Study Guide.

ERIC Educational Resources Information Center

Coelho, George V., Ed.; Irving, Richard I., Ed.

This annotated bibliography concerns the styles and strategies used to cope with stressful situations and to adapt to pathological conditions, and provides mental health researchers and practitioners with recent, relevant mental health information on theoretical, developmental, clinical, behavioral, and social issues about coping and adaptation.…

Does a Therapist's World View Matter?

PubMed

Peteet, John R; Rodriguez, Vithya B; Herschkopf, Marta D; McCarthy, Alyssa; Betts, Jennifer; Romo, Stephanie; Michael Murphy, J

2016-06-01

While past research indicates that mental health professionals are less religious than the public they serve, little is known about the implications of therapists' world views for their practice. In this study, approximately 50 therapists completed surveys that assessed self-identification in relation to spirituality, religion, and/or world view; how relevant they considered their patients' and their own world views; and responses to clinical vignettes involving issues arising in treatment. While a minority considered themselves religious, a majority indicated that they considered themselves moderately or very spiritual. When asked how they would respond to a series of clinical vignettes involving topics such as assisted suicide and encouraging the use of spiritual resources, responses varied significantly by world view. Respondents endorsed several factors limiting the integration of religion/spiritualities/world views into their clinical work. These data raise questions about how to further explore the clinical relevance of the therapist's world view.

Reshaping clinical science: Introduction to the Special Issue on Psychophysiology and the NIMH Research Domain Criteria (RDoC) initiative.

PubMed

Patrick, Christopher J; Hajcak, Greg

2016-03-01

The National Institute of Mental Health's (NIMH) Research Domain Criteria (RDoC) initiative seeks to establish new dimensional conceptions of mental health problems, through the investigation of clinically relevant "process" constructs that have neurobiological as well as psychological referents. This special issue provides a detailed overview of the RDoC framework by NIMH officials Michael Kozak and Bruce Cuthbert, and spotlights RDoC-oriented investigative efforts by leading psychophysiological research groups as examples of how clinical science might be reshaped through application of RDoC principles. Accompanying commentaries highlight key aspects of the work by each group, and discuss reported methods/findings in relation to promises and challenges of the RDoC initiative more broadly. © 2016 Society for Psychophysiological Research.

Resistance Management Techniques of Milton H. Erickson, M.D.: An Application to Nonhypnotic Mental Health Counseling.

ERIC Educational Resources Information Center

Otani, Akira

1989-01-01

Delineates five selected hypnotically based techniques of client resistance management pioneered by Milton H. Erickson: acceptance; paradoxical encouragement; reframing; displacement; dissociation. Explains how techniques can be applied to nonhypnotic mental health counseling. Discusses relevant clinical, theoretical, and empirical issues related…

Warning Signs for Suicide: Theory, Research, and Clinical Applications

ERIC Educational Resources Information Center

Rudd, M. David; Berman, Alan L.; Joiner, Thomas E., Jr.; Nock, Matthew K.; Silverman, Morton M.; Mandrusiak, Michael; Van Orden, Kimberly; Witte, Tracy

2006-01-01

The current article addresses the issue of warning signs for suicide, attempting to differentiate the construct from risk factors. In accordance with the characteristic features discussed, a consensus set of warning signs identified by the American Association of Suicidology working group are presented, along with a discussion of relevant clinical…

42 CFR 426.540 - Evidence.

Code of Federal Regulations, 2010 CFR

2010-10-01

... of expert witnesses on scientific and clinical issues, rebuttal witnesses, and other relevant... Board or a party to the proceeding, or the report will be excluded from the record. (f) Except as set..., all documents and other evidence offered or taken for the record is open to examination by all parties. ...

42 CFR 426.540 - Evidence.

Code of Federal Regulations, 2014 CFR

2014-10-01

... testimony of expert witnesses on scientific and clinical issues, rebuttal witnesses, and other relevant... Board or a party to the proceeding, or the report will be excluded from the record. (f) Except as set..., all documents and other evidence offered or taken for the record is open to examination by all parties. ...

42 CFR 426.540 - Evidence.

Code of Federal Regulations, 2012 CFR

2012-10-01

... testimony of expert witnesses on scientific and clinical issues, rebuttal witnesses, and other relevant... Board or a party to the proceeding, or the report will be excluded from the record. (f) Except as set..., all documents and other evidence offered or taken for the record is open to examination by all parties. ...

From clinical trial to prescription.

PubMed

Carpenter, William T

2002-03-01

There are many steps between drug discovery and prescribing for a patient. Each step has problems. In this issue of ARCHIVES, Klein and colleagues propose changes in clinical trials that would result in more meaningful information for the treating physician. Of particular importance is the gap between what a physician needs to know and what is produced in the clinical trials that leads to approval of a new drug by the US Food and Drug Administration (FDA). Their recommendations for improving clinical trials are cogent, but broad-based implementation depends on an organizational structure and political effectiveness not presently in place. Most important, as the authors note, is an effective work group representing industry, regulatory agencies, and academic and federal science, addressing clinical trials issues with public participation. While improved quality and relevance of data from clinical trials will strengthen the scientific foundation of pharmacotherapy, other problems impede the delivery of objective information to the treating physician. Most hotly debated is the role of money in the creation and dissemination of knowledge.

Physicians' and nurses' expectations and objections toward a clinical ethics committee.

PubMed

Jansky, Maximiliane; Marx, Gabriella; Nauck, Friedemann; Alt-Epping, Bernd

2013-11-01

The study aimed to explore the subjective need of healthcare professionals for ethics consultation, their experience with ethical conflicts, and expectations and objections toward a Clinical Ethics Committee. Staff at a university hospital took part in a survey (January to June 2010) using a questionnaire with open and closed questions. Descriptive data for physicians and nurses (response rate = 13.5%, n = 101) are presented. Physicians and nurses reported similar high frequencies of ethical conflicts but rated the relevance of ethical issues differently. Nurses stated ethical issues as less important to physicians than to themselves. Ethical conflicts were mostly discussed with staff from one's own profession. Respondents predominantly expected the Clinical Ethics Committee to provide competent support. Mostly, nurses feared it might have no influence on clinical practice. Findings suggest that experiences of ethical conflicts might reflect interprofessional communication patterns. Expectations and objections against Clinical Ethics Committees were multifaceted, and should be overcome by providing sufficient information. The Clinical Ethics Committee needs to take different perspectives of professions into account.

Developing core outcome sets for clinical trials: issues to consider

PubMed Central

2012-01-01

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus. PMID:22867278

Approaches to biofilm-associated infections: the need for standardized and relevant biofilm methods for clinical applications.

PubMed

Malone, Matthew; Goeres, Darla M; Gosbell, Iain; Vickery, Karen; Jensen, Slade; Stoodley, Paul

2017-02-01

The concept of biofilms in human health and disease is now widely accepted as cause of chronic infection. Typically, biofilms show remarkable tolerance to many forms of treatments and the host immune response. This has led to vast increase in research to identify new (and sometimes old) anti-biofilm strategies that demonstrate effectiveness against these tolerant phenotypes. Areas covered: Unfortunately, a standardized methodological approach of biofilm models has not been adopted leading to a large disparity between testing conditions. This has made it almost impossible to compare data across multiple laboratories, leaving large gaps in the evidence. Furthermore, many biofilm models testing anti-biofilm strategies aimed at the medical arena have not considered the matter of relevance to an intended application. This may explain why some in vitro models based on methodological designs that do not consider relevance to an intended application fail when applied in vivo at the clinical level. Expert commentary: This review will explore the issues that need to be considered in developing performance standards for anti-biofilm therapeutics and provide a rationale for the need to standardize models/methods that are clinically relevant. We also provide some rational as to why no standards currently exist.

Novel Paths to Relevance: How Clinical Ethics Committees Promote Ethical Reflection.

PubMed

Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

2016-09-01

How may clinical ethics committees (CECs) inspire ethical reflection among healthcare professionals? How may they deal with organizational ethics issues? In recent years, Norwegian CECs have attempted different activites that stretch or go beyond the standard trio of education, consultation, and policy work. We studied the novel activities of Norwegian CECs by examining annual reports and interviewing CEC members. Through qualitative analysis we identified nine categories of novel CEC activities, which we describe by way of examples. In light of the findings, we argue that some novel working methods may be well suited to promote ethical reflection among clinicians, and that the CEC may be a suitable venue for discussing issues of organizational ethics.

Context is everything: From cardiovascular disease to cerebral microbleeds.

PubMed

Charidimou, Andreas; Blacker, Deborah; Viswanathan, Anand

2018-01-01

Increasingly, our approach to cerebrovascular disease has become blurred by evidence published in literature often without careful consideration of what this evidence implies for specific patients at hand. In this essay, we analyze key contextual issues in cerebrovascular small vessel disease, in an attempt to highlight the symbolic gap that exists between research and clinical practice, a recurring theme in medicine. We highlight the importance of considering context when using data from epidemiologic, neuroimaging, and biomarker studies in determining relevance to the patient at hand. We argue, that while biomarkers and neuroimaging may eventually serve to help to identify individuals with specific cerebrovascular diseases, we must always continue to understand patients in a specific clinical context. These reflections are particularly relevant when considering cerebral microbleeds-a key marker of cerebrovascular small vessel disease whose detection often raises thorny clinical dilemmas.

Current transcatheter devices to treat functional tricuspid regurgitation with discussion of issues relevant to clinical trial design

PubMed Central

2017-01-01

Functional or secondary tricuspid regurgitation (TR) has seen increased attention in recent times as relationships with clinically-relevant outcomes have come to light. Despite the association of increased mortality with significant TR, the disease remains under-recognized and thus relatively untreated. In addition, the disease itself has not been extensively studied and the interactions between annular dilatation, right heart disease and pulmonary hypertension are poorly understood. However, the high mortality and recurrence rate with current surgical replacement or repair techniques is well recognised, opening the door to transcatheter therapies for functional TR. The current perspective reviews the rationale for transcatheter solutions, describes some of the current approaches and discusses the ongoing questions of a poorly-studied condition which may limit the design of clinical trials for this disease. PMID:28706866

Disaster Mental Health and Positive Psychology-Considering the Context of Natural and Technological Disasters: An Introduction to the Special Issue.

PubMed

Schulenberg, Stefan E

2016-12-01

This article serves as an introduction to the Journal of Clinical Psychology's special issue on disaster mental health and positive psychology. The special issue comprises two sections. The first section presents a series of data-driven articles and research-informed reviews examining meaning and resilience in the context of natural and technological disasters. The second section presents key topics in the area of disaster mental health, with particular relevance for positive psychology and related frameworks. The special issue is intended to bridge the gap between these two areas of applied science, with the audience being experienced clinicians or clinicians in training. © 2016 Wiley Periodicals, Inc.

Initiation of universal tumor screening for Lynch syndrome in colorectal cancer patients as a model for the implementation of genetic information into clinical oncology practice.

PubMed

Cohen, Stacey A; Laurino, Mercy; Bowen, Deborah J; Upton, Melissa P; Pritchard, Colin; Hisama, Fuki; Jarvik, Gail; Fichera, Alessandro; Sjoding, Britta; Bennett, Robin L; Naylor, Lorraine; Jacobson, Angela; Burke, Wylie; Grady, William M

2016-02-01

Lynch syndrome confers a hereditary predisposition to colorectal and other cancers. Universal tumor screening (UTS) for Lynch syndrome is recommended by several professional societies, but the implementation can be complex. This article describes the evaluation, process development, and initiation of Lynch syndrome UTS at a tertiary referral cancer center. A multidisciplinary team developed the new process design. Issues in 5 themes were noted: timing, funding, second-opinion patients, result processing, and the role of genetics providers. A committee approach was used to examine each issue for process-improvement development. The issues related to testing were addressed individually for the successful implementation of UTS at the institutional level. In the conventional-care period, 9 of 30 cases (30%) received Lynch syndrome screening, and 4 cases were referred to medical genetics. During the 6 months following the implementation of UTS, 32 of 44 patients (73%) received Lynch syndrome screening. The 13 unscreened patients all had identified reasons for nonscreening (eg, financial limitations). Ten patients were referred to medical genetics, which identified no new cases of Lynch syndrome, but a low-risk adenomatous polyposis coli (APC) variant was detected in 1 individual. The implementation of effective Lynch syndrome UTS can feasibly alter practice at the institutional level. This experience with the assessment and management of issues relevant to the successful implementation of a new clinical care paradigm based on emerging technology has implications for the uptake of advances across molecular oncology into clinical practice, and this is highly relevant in the current era of rapidly evolving genomic technology. © 2015 American Cancer Society.

Detection of HLA Antibodies in Organ Transplant Recipients – Triumphs and Challenges of the Solid Phase Bead Assay

PubMed Central

Tait, Brian D.

2016-01-01

This review outlines the development of human leukocyte antigen (HLA) antibody detection assays and their use in organ transplantation in both antibody screening and crossmatching. The development of sensitive solid phase assays such as the enzyme-linked immunosorbent assay technique, and in particular the bead-based technology has revolutionized this field over the last 10–15 years. This revolution however has created a new paradigm in clinical decision making with respect to the detection of low level pretransplant HLA sensitization and its clinical relevance. The relative sensitivities of the assays used are discussed and the relevance of conflicting inter-assay results. Each assay has its advantages and disadvantages and these are discussed. Over the last decade, the bead-based assay utilizing the Luminex® fluorocytometer instrument has become established as the “gold standard” for HLA antibody testing. However, there are still unresolved issues surrounding this technique, such as the presence of denatured HLA molecules on the beads which reveal cryptic epitopes and the issue of appropriate fluorescence cut off values for positivity. The assay has been modified to detect complement binding (CB) in addition to non-complement binding (NCB) HLA antibodies although the clinical relevance of the CB and NCB IgG isotypes is not fully resolved. The increase sensitivity of the Luminex® bead assay over the complement-dependent cytotoxicity crossmatch has permitted the concept of the “virtual crossmatch” whereby the crossmatch is predicted to a high degree of accuracy based on the HLA antibody specificities detected by the solid phase assay. Dialog between clinicians and laboratory staff on an individual patient basis is essential for correct clinical decision making based on HLA antibody results obtained by the various techniques. PMID:28018342

New Insights into the Surgical Management of Tetralogy of Fallot: Physiological Fundamentals and Clinical Relevance.

PubMed

Bove, Thierry; François, Katrien; De Wolf, Daniel

2015-01-01

The surgical treatment of tetralogy of Fallot can be considered as a success story in the history of congenital heart diseases. Since the early outcome is no longer the main issue, the focus moved to the late sequelae of TOF repair, i.e. the pulmonary insufficiency and the secondary adaptation of the right ventricle. This review provides recent insights into the pathophysiological alterations of the right ventricle in relation to the reconstruction of the right ventricular outflow tract after repair of tetralogy of Fallot. Its clinical relevance is documented by addressing the policy changes regarding the optimal management at the time of surgical repair as well as properly defining criteria and timing for late pulmonary valve implantation.

Integration of medicine and basic science in dentistry: the role of oral and maxillofacial surgery in the pre-doctoral dental curriculum.

PubMed

Dennis, Matthew J

2010-05-01

It is the premise of this paper that the need for medical and basic science instruction in dentistry will increase over time. However, student and faculty appreciation of the relevance and significance of medicine and basic science to clinical dentistry has been elusive, largely due to difficulties linking biomedical science instruction and clinical dental instruction. The scope of traditional procedure based oral surgery instruction can be expanded in an attempt to bridge the medical science-clinical gap. Topics such as health status evaluation, medical risk assessment, and a variety of other biomedical issues can be presented to students in a way which imparts specific dental meaning to basic medical science in real-life clinical situations. Using didactic and chair side instruction in an oral surgery clinical environment, students are confronted with the need to understand these issues and how they relate to the patients they encounter who present for dental care.

Assessment in health psychology: Introduction to the special issue.

PubMed

Butt, Zeeshan

2016-09-01

For the past 27 years, Psychological Assessment has been committed to publishing empirical research relevant to clinical assessment of basic and applied cognition, personality, interpersonal behavior, psychopathology, forensics, and biological psychology. There is growing interest in the use of patient-centered outcomes in medical/surgical care and for measuring health care performance. Patient-centered outcome measures complement traditional clinical outcomes of morbidity and mortality, capturing the patient’s perspective regarding their health and its treatment. In this issue, we highlight 11 articles that address different aspects of such work. The articles in this special issue represent both the depth and breadth of the opportunities that exist for psychological assessment in the health setting. While there are countless patient-centered measures currently in use to measure health and health outcomes, the evidence base for their use can be quite variable (Butt, 2016). The hope is that future issues of Psychological Assessment will highlight more work in this area. PsycINFO Database Record (c) 2016 APA, all rights reserved

A report on older-age bipolar disorder from the International Society for Bipolar Disorders Task Force

PubMed Central

Sajatovic, Martha; Strejilevich, Sergio A; Gildengers, Ariel G; Dols, Annemiek; Al Jurdi, Rayan K; Forester, Brent P; Kessing, Lars Vedel; Beyer, John; Manes, Facundo; Rej, Soham; Rosa, Adriane R; Schouws, Sigfried NTM; Tsai, Shang-Ying; Young, Robert C; Shulman, Kenneth I

2015-01-01

Objectives In the coming generation, older adults with bipolar disorder (BD) will increase in absolute numbers as well as proportion of the general population. This is the first report of the International Society for Bipolar Disorder (ISBD) Task Force on Older-Age Bipolar Disorder (OABD). Methods This task force report addresses the unique aspects of OABD including epidemiology and clinical features, neuropathology and biomarkers, physical health, cognition, and care approaches. Results The report describes an expert consensus summary on OABD that is intended to advance the care of patients, and shed light on issues of relevance to BD research across the lifespan. Although there is still a dearth of research and health efforts focused on older adults with BD, emerging data has brought some answers, innovative questions, and novel perspectives related to the notion of late onset, medical comorbidity, and the vexing issue of cognitive impairment and decline. Conclusions Improving our understanding of the biological, clinical, and social underpinnings relevant to OABD is an indispensable step in building a complete map of BD across the lifespan. PMID:26384588

Religion, Spirituality and Speech-Language Pathology: A Viewpoint for Ensuring Patient-Centred Holistic Care.

PubMed

Mathisen, Bernice; Carey, Lindsay B; Carey-Sargeant, Christa L; Webb, Gwendalyn; Millar, CaraJane; Krikheli, Lilli

2015-12-01

This paper presents a viewpoint concerning the largely neglected clinical relevance of spirituality and religious belief in speech-language pathology (SLP) assessments, interventions and outcomes across the lifespan. An overview of the refereed SLP literature is presented with regard to religion and spirituality. It was found that while there is increasing research with regard to spirituality, health and well-being, there is very little specific to SLP. What is available and clinically relevant, generally relates to holistic care and/or cultural and linguistic diversity. Amidst the health care literature, however, there is a growing number of recommended instruments (for religious/spiritual screening) sensitive to intercultural and interfaith issues that are currently available to medical, nursing, allied health and chaplaincy practitioners. These instruments can also be of value to SLPs to ensure holistic assessments and interventions. It would seem timely for SLPs (and other allied health practitioners) to consider including spiritual screenings/assessments as part of their clinical practice so as to ensure appropriate holistic care. This would also mean undertaking research and including relevant education within tertiary institutions and professional development programs.

Automation and apps for clinical dental biomechanics.

PubMed

Adams, Bruce W

2016-09-01

The aim of this research summary is to introduce the current and ongoing work using smartphone video, tracking markers to measure musculoskeletal disorders of cranial and mandibular origin, and the potential significance of the technology to doctors and therapists. The MPA™ biomechanical measuring apps are in beta trials with various doctors and therapists. The technique requires substantial image processing and statistical analysis, best suited to server-side processing. A smartphone environment has enabled a virtual laboratory, which provides automated generation of graphics and in some cases automated interpretation. The system enables highly accurate real-time biomechanics studies using only a smartphone and tracking markers. Despite the technical challenges in setting up and testing of the virtual environment and with interpretation of clinical relevance, the trials have enabled a demonstration of real-time biomechanics studies. The technology has prompted a lot of discussion about the relevance of rapid assessment tools in clinical practice. It seems that a prior bias against motion tracking and its relevance is very strong with occlusion related use cases, yet there has been a general agreement about the use case for cranial movement tracking in managing complex issues related to the head, neck, and TMJ. Measurement of cranial and mandibular functions using a smartphone video as the input have been investigated. Ongoing research will depend upon doctors and therapists to provide feedback as to which uses are considered clinically relevant.

Amnesia and crime: a neuropsychiatric response.

PubMed

Wortzel, Hal S; Arciniegas, David B

2008-01-01

Bourget and Whitehurst's "Amnesia and Crime," published in a prior issue of the Journal, addresses a conceptually complex and clinically challenging subject. Their treatment emphasizes psychiatric conditions in which memory disturbances may arise that are relevant to criminal proceedings. However, their consideration of the neurobiology of memory, memory disturbances, and the neurobiological bases of interactions between psychiatric symptoms and memory merit further elaboration. The relevance of memory impairment to criminal matters requires forensic psychiatric experts to possess a basic understanding of the phenomenology and neurobiology of memory. The present authors describe briefly the phenomenology and neuroanatomy of memory, emphasizing first that memory is not a unitary cognitive domain, clinically or neurobiologically. The assertion that psychotic delusions produce memory impairment is challenged, and the description of "organic" amnesia, both semantically and in terms of its clinical features, is reframed. Resources on which to build a neuropsychiatric foundation for forensic psychiatric opinions on memory impairment surrounding criminal behavior are offered.

Systematic reviews: guidance relevant for studies of older people

PubMed Central

Wilkinson, Tim; Dodds, Richard M.; Ioannidis, John P. A.

2017-01-01

Abstract Systematic reviews and meta-analyses are increasingly common. This article aims to provide guidance for people conducting systematic reviews relevant to the healthcare of older people. An awareness of these issues will also help people reading systematic reviews to determine whether the results will influence their clinical practice. It is essential that systematic reviews are performed by a team which includes the required technical and clinical expertise. Those performing reviews for the first time should ensure they have appropriate training and support. They must be planned and performed in a transparent and methodologically robust way: guidelines are available. The protocol should be written—and if possible published—before starting the review. Geriatricians will be interested in a table of baseline characteristics, which will help to determine if the studied samples or populations are similar to their patients. Reviews of studies of older people should consider how they will manage issues such as different age cut-offs; non-specific presentations; multiple predictors and outcomes; potential biases and confounders. Systematic reviews and meta-analyses may provide evidence to improve older people's care, or determine where new evidence is required. Newer methodologies, such as meta-analyses of individual level data, network meta-analyses and umbrella reviews, and realist synthesis, may improve the reliability and clinical utility of systematic reviews. PMID:28655142

A review of issues and concerns of family members of adult burn survivors.

PubMed

Sundara, Diana C

2011-01-01

The purpose of this review is to synthesize what is known about the issues and concerns of families of adult burn survivors from research and clinical articles written between 1973 and 2009. Electronic database searching, ancestry searching, and electronic hand searching were performed to identify relevant articles. Seventeen research studies and 14 clinical articles were identified. Families are often in crisis immediately after the injury. This crisis involves strong emotions, some of which may persist over time. Throughout the course of hospitalization, family issues include worries about their loved one's physical appearance, logistical concerns, and the transition to home. For partners, role changes and sexual concerns may be of particular importance. Extended family, friends, the burn team, and other families affected by a burn injury are important sources of support for family members. Few studies have been conducted beyond the time of hospitalization. Clinical articles have identified issues not present in the research literature. Further research is needed that focuses more closely on families and their experiences both in and out of the hospital. Implications for burn care providers based on the findings of this review are discussed.

DESIGNING PHARMACEUTICAL TRIALS FOR SARCOPENIA IN FRAIL OLDER ADULTS: EU/US TASK FORCE RECOMMENDATIONS

PubMed Central

VELLAS, B.; PAHOR, M.; MANINI, T.; ROOKS, D.; GURALNIK, J.M.; MORLEY, J.; STUDENSKI, S.; EVANS, W.; ASBRAND, C.; FARIELLO, R.; PEREIRA, S.; ROLLAND, Y.; VAN KAN, G. ABELLAN; CESARI, M.; CHUMLEA, WM.C.; FIELDING, R.

2014-01-01

An international task force of academic and industry leaders in sarcopenia research met on December 5, 2012 in Orlando, Florida to develop guidelines for designing and executing randomized clinical trials of sarcopenia treatments. The Task Force reviewed results from previous trials in related disease areas to extract lessons relevant to future sarcopenia trials, including practical issues regarding the design and conduct of trials in elderly populations, the definition of appropriate target populations, and the selection of screening tools, outcome measures, and biomarkers. They discussed regulatory issues, the challenges posed by trials of different types of interventions, and the need for standardization and harmonization. The Task Force concluded with recommendations for advancing the field toward better clinical trials. PMID:23933872

Surrogacy in modern obstetric practice.

PubMed

Burrell, Celia; Edozien, Leroy C

2014-10-01

Surrogacy is rising in profile and prevalence, which means that perinatal care providers face an increasing likelihood of encountering a case in their clinical practice. Rapidly expanding scientific knowledge (for example, fetal programming) and technological advances (for example, prenatal screening and diagnosis) pose challenges in the management of the surrogate mother; in particular, they could exacerbate conflict between the interests of the baby, the surrogate mother, and the intending parent(s). Navigating these often-tranquil-but-sometimes-stormy waters is facilitated if perinatal care providers are aware of the relevant ethical, legal, and service delivery issues. This paper describes the ethical and legal context of surrogacy, and outlines key clinical practice issues in management of the surrogate mother. Copyright © 2014 Elsevier Ltd. All rights reserved.

Dialysis access: an increasingly important clinical issue.

PubMed

Gallieni, Maurizio; Martini, Alma; Mezzina, Nicoletta

2009-12-01

Dialysis access, including vascular access for hemodialysis and peritoneal access for peritoneal dialysis, is critical in the clinical care of patients with end-stage renal disease. It is associated with increases in morbidity, mortality, and health care costs. A number of problematic issues are involved, some of which are addressed in this paper with reference to the most recent publications, including: the inappropriately low prevalence of peritoneal dialysis in Western countries, which is relevant to access placement in the pre-dialysis stage; the excessively high use of central venous catheters in incident and prevalent dialysis patients; the diagnosis and treatment of steal syndrome; the advantages and limitations of antiplatelet therapy; and finally, the correct pre-operative evaluation and subsequent surveillance of the vascular access.

Measuring patient safety in a UK dental hospital: development of a dental clinical effectiveness dashboard.

PubMed

Pemberton, M N; Ashley, M P; Shaw, A; Dickson, S; Saksena, A

2014-10-01

Patient safety is an important marker of quality for any healthcare organisation. In 2008, the British Government white paper entitled High quality care for all, resulting from a review led by Lord Darzi, identified patient safety as a key component of quality and discussed how it might be measured, analysed and acted upon. National and local clinically curated metrics were suggested, which could be displayed via a 'clinical dashboard'. This paper explains the development of a clinical effectiveness dashboard focused on patient safety in an English dental hospital and how it has helped us identify relevant patient safety issues in secondary dental care.

The relevance of psychodynamic psychotherapy to understanding therapist-patient sexual abuse and treatment of survivors.

PubMed

Yahav, Rivka; Oz, Sheri

2006-01-01

Regardless of the therapy modality, research continues to point to the therapeutic relationship as a major salient factor in clinical success or failure. When a patient is sexually abused by his or her therapist, this therapeutic relationship is cynically exploited in a way that does not properly serve the essential needs of the patient. When this patient then seeks reparative therapy, the subsequent therapist needs to pay close attention to issues of the relationship which were breached by the previous clinician. In this article, two case studies showing very different dynamics will be presented in order to demonstrate: (1) relevant factors related to transference, countertransference, projective identification, and the analytic third pertaining to the former, abusive therapy; and (2) needs versus wishes, and issues related to boundaries and self-disclosure in the corrective therapy.

Perspectives on Individual Differences Affecting Therapeutic Change in Communication Disorders. New Directions in Communication Disorders Research

ERIC Educational Resources Information Center

Weiss, Amy L., Ed.

2009-01-01

This volume examines the ramifications of individual differences in therapy outcomes for a wide variety of communication disorders. In an era where evidence-based practice is the clinical profession's watchword, each chapter attacks this highly relevant issue from a somewhat different perspective. In some areas of communication disorders,…

A Cross-Cultural Comparison of Belgian and Vietnamese Children's Social Competence and Behavior

ERIC Educational Resources Information Center

Roskam, Isabelle; Hoang, Thi Vân; Schelstraete, Marie-Anne

2017-01-01

Children's social competence and behavioral adjustment are key issues for child development, education, and clinical research. Cross-cultural analyses are necessary to provide relevant methods of assessing them for cross-cultural research. The aim of the current study was to contribute to this important line of research by validating the 3-factor…

A data-driven approach to quality risk management.

PubMed

Alemayehu, Demissie; Alvir, Jose; Levenstein, Marcia; Nickerson, David

2013-10-01

An effective clinical trial strategy to ensure patient safety as well as trial quality and efficiency involves an integrated approach, including prospective identification of risk factors, mitigation of the risks through proper study design and execution, and assessment of quality metrics in real-time. Such an integrated quality management plan may also be enhanced by using data-driven techniques to identify risk factors that are most relevant in predicting quality issues associated with a trial. In this paper, we illustrate such an approach using data collected from actual clinical trials. Several statistical methods were employed, including the Wilcoxon rank-sum test and logistic regression, to identify the presence of association between risk factors and the occurrence of quality issues, applied to data on quality of clinical trials sponsored by Pfizer. ONLY A SUBSET OF THE RISK FACTORS HAD A SIGNIFICANT ASSOCIATION WITH QUALITY ISSUES, AND INCLUDED: Whether study used Placebo, whether an agent was a biologic, unusual packaging label, complex dosing, and over 25 planned procedures. Proper implementation of the strategy can help to optimize resource utilization without compromising trial integrity and patient safety.

Using data and quality monitoring to enhance maternity outcomes: a qualitative study of risk managers' perspectives.

PubMed

Simms, Rebecca A; Yelland, Andrew; Ping, Helen; Beringer, Antonia J; Draycott, Timothy J; Fox, Robert

2014-06-01

Risk management is a core part of healthcare practice, especially within maternity services, where litigation and societal costs are high. There has been little investigation into the experiences and opinions of those staff directly involved in risk management: lead obstetricians and specialist risk midwives, who are ideally placed to identify how current implementation of risk management strategies can be improved. A qualitative study of consultant-led maternity units in an English region. Semistructured interviews were conducted with the obstetric and midwifery risk management leads for each unit. We explored their approach to risk management, particularly their opinions regarding quality monitoring and related barriers/issues. Interviews were recorded, transcribed and thematically analysed. Twenty-seven staff from 12/15 maternity units participated. Key issues identified included: concern for the accuracy and validity of their local data, potential difficulties related to data collation, the negative impact of external interference by national regulatory bodies on local clinical priorities, the influence of the local culture of the maternity unit on levels of engagement in the risk management process, and scepticism about the value of benchmarking of maternity units without adjustment for population characteristics. Local maternity risk managers may provide valuable, clinically relevant insights into current issues in clinical data monitoring. Improvements should focus on the accuracy and ease of data collation with a need for an agreed maternity indicators set, populated from validated databases, and not reliant on data collection systems that distract clinicians from patient activity and quality improvement. It is clear that working relationships between risk managers, their own clinical teams and external national bodies require improvement and alignment. Further discussion regarding benchmarking between maternity units is required prior to implementation. These findings are likely to be relevant to other clinical specialties. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Knowledge management strategies: Enhancing knowledge transfer to clinicians and patients.

PubMed

Roemer, Lorrie K; Rocha, Roberto A; Del Fiol, Guilherme; Bradshaw, Richard L; Hanna, Timothy P; Hulse, Nathan C

2006-01-01

At Intermountain Healthcare (Intermountain), executive clinical content experts are responsible for disseminating consistent evidence-based clinical content throughout the enterprise at the point-of-care. With a paper-based system it was difficult to ensure that current information was received and was being used in practice. With electronic information systems multiple applications were supplying similar, but different, vendor-licensed and locally-developed content. These issues influenced the consistency of clinical practice within the enterprise, jeopardized patient and clinician safety, and exposed the enterprise and its employees to potential financial penalties. In response to these issues Intermountain is developing a knowledge management infrastructure providing tools and services to support clinical content development, deployment, maintenance, and communication. The Intermountain knowledge management philosophy includes strategies guiding clinicians and consumers of health information to relevant best practice information with the intention of changing behaviors. This paper presents three case studies describing different information management problems identified within Intermountain, methods used to solve the problems, implementation challenges, and the current status of each project.

Cryopreserved or Fresh Mesenchymal Stromal Cells: Only a Matter of Taste or Key to Unleash the Full Clinical Potential of MSC Therapy?

PubMed

Moll, Guido; Geißler, Sven; Catar, Rusan; Ignatowicz, Lech; Hoogduijn, Martin J; Strunk, Dirk; Bieback, Karen; Ringdén, Olle

2016-01-01

Mesenchymal stromal cells (MSCs) harbor great therapeutic potential for numerous diseases. From early clinical trials, success and failure analysis, bench-to-bedside and back-to-bench approaches, there has been a great gain in knowledge, still leaving a number of questions to be answered regarding optimal manufacturing and quality of MSCs for clinical application. For treatment of many acute indications, cryobanking may remain a prerequisite, but great uncertainty exists considering the therapeutic value of freshly thawed (thawed) and continuously cultured (fresh) MSCs. The field has seen an explosion of new literature lately, outlining the relevance of the topic. MSCs appear to have compromised immunomodulatory activity directly after thawing for clinical application. This may provide a possible explanation for failure of early clinical trials. It is not clear if and how quickly MSCs recover their full therapeutic activity, and if the "cryo stun effect" is relevant for clinical success. Here, we will share our latest insights into the relevance of these observations for clinical practice that will be discussed in the context of the published literature. We argue that the differences of fresh and thawed MSCs are limited but significant. A key issue in evaluating potency differences is the time point of analysis after thawing. To date, prospective double-blinded randomized clinical studies to evaluate potency of both products are lacking, although recent progress was made with preclinical assessment. We suggest refocusing therapeutic MSC development on potency and safety assays with close resemblance of the clinical reality.

Thought for application and application with thought: issues in theoretical thinking and practical wisdom.

PubMed

Jenkins, Sandra K; Thomas, Mary Beth

2005-01-01

Both theoretical thinking and practical wisdom are used by health professionals in their clinical practice. Lately, discussion has centered on the abstract phrase "theory-practice gap." The health profession is not the only discipline that seeks unity in theory and practice issues. Education is also building bridges in this arena. One reoccurring myth is the notion that theory and practice are separate; as a result, this gives a mistaken impression that theory serves no purpose in practice. Discussion of the issues in this paper includes definitions of theoretical thinking and practical wisdom, theoretical and practical knowledge development, and relevance to health professional's education, practice and science. These issues must be communicated to practitioners, educators and theorists. A collective definition to begin communication is proposed and suggestions are offered for addressing key issues.

A note on cognitive dissonance and malingering.

PubMed

Merckelbach, Harald; Merten, Thomas

2012-01-01

This paper proposes that malingered symptoms may become internalized due to the self-deceptive power of cognitive dissonance. Studies demonstrating how other-deception may turn into self-deception are briefly discussed, as are clinical notions about the overlap between malingering and medically unexplained symptoms. In our view this literature showcases the relevance of cognitive dissonance for research on malingering. A cognitive dissonance perspective may help to clarify how ambiguous sensations may escalate into subjectively compelling symptoms. This perspective suggests that malingered symptom reports are more than just a complication during psychological evaluation. It may generate new research avenues and may clarify practically relevant issues.

Atrioventricular and intraventricular block after transcatheter aortic valve implantation.

PubMed

Lee, Jane J; Goldschlager, Nora; Mahadevan, Vaikom S

2018-06-24

Aortic stenosis is the most common valvular heart disease in industrialized countries and the most common cause of left ventricular outflow tract (LVOT) obstruction. Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for intermediate to high-risk surgical candidates with symptomatic severe aortic stenosis. Conduction system abnormalities, including atrioventricular (AV) and intraventricular (IV) block, are the most common complication of TAVR. In this review, we aim to explore the anatomical issues relevant to atrioventricular block, the relevant clinical and procedural aspects, and the management and long-term implications of AV and IV block.

Everyday ethics in internal medicine resident clinic: an opportunity to teach.

PubMed

Carrese, Joseph A; McDonald, Erin L; Moon, Margaret; Taylor, Holly A; Khaira, Kiran; Catherine Beach, Mary; Hughes, Mark T

2011-07-01

Being a good doctor requires competency in ethics. Accordingly, ethics education during residency training is important. We studied the everyday ethics-related issues (i.e. ordinary ethics issues commonly faced) that internal medical residents encounter in their out-patient clinic and determined whether teaching about these issues occurred during faculty preceptor-resident interactions. This study involved a multi-method qualitative research design combining observation of preceptor-resident discussions with preceptor interviews. The study was conducted in two different internal medicine training programme clinics over a 2-week period in June 2007. Fifty-three residents and 19 preceptors were observed, and 10 preceptors were interviewed. Transcripts of observer field notes and faculty interviews were carefully analysed. The analysis identified several themes of everyday ethics issues and determined whether preceptors identified and taught about these issues. Everyday ethics content was considered present in 109 (81%) of the 135 observed case presentations. Three major thematic domains and associated sub-themes related to everyday ethics issues were identified, concerning: (i) the Doctor-Patient Interaction (relationships; communication; shared decision making); (ii) the Resident as Learner (developmental issues; challenges and conflicts associated with training; relationships with colleagues and mentors; interactions with the preceptor), and; (iii) the Doctor-System Interaction (financial issues; doctor-system issues; external influences; doctor frustration related to system issues). Everyday ethics issues were explicitly identified by preceptors (without teaching) in 18 of 109 cases (17%); explicit identification and teaching occurred in only 13 cases (12%). In this study a variety of everyday ethics issues were frequently encountered as residents cared for patients. Yet, faculty preceptors infrequently explicitly identified or taught these issues during their interactions with residents. Ethics education is important and residents may regard teaching about the ethics-related issues they actually encounter to be highly relevant. A better understanding of the barriers to teaching is needed in order to promote education about everyday ethics in the out-patient setting. © Blackwell Publishing Ltd 2011.

Everyday ethics in internal medicine resident clinic: an opportunity to teach

PubMed Central

Carrese, Joseph A; McDonald, Erin L; Moon, Margaret; Taylor, Holly A; Khaira, Kiran; Beach, Mary Catherine; Hughes, Mark T

2011-01-01

OBJECTIVES Being a good doctor requires competency in ethics. Accordingly, ethics education during residency training is important. We studied the everyday ethics-related issues (i.e. ordinary ethics issues commonly faced) that internal medical residents encounter in their out-patient clinic and determined whether teaching about these issues occurred during faculty preceptor–resident interactions. METHODS This study involved a multi-method qualitative research design combining observation of preceptor-resident discussions with preceptor interviews. The study was conducted in two different internal medicine training programme clinics over a 2-week period in June 2007. Fifty-three residents and 19 preceptors were observed, and 10 preceptors were interviewed. Transcripts of observer field notes and faculty interviews were carefully analysed. The analysis identified several themes of everyday ethics issues and determined whether preceptors identified and taught about these issues. RESULTS Everyday ethics content was considered present in 109 (81%) of the 135 observed case presentations. Three major thematic domains and associated sub-themes related to everyday ethics issues were identified, concerning: (i) the Doctor–Patient Interaction (relationships; communication; shared decision making); (ii) the Resident as Learner (developmental issues; challenges and conflicts associated with training; relationships with colleagues and mentors; interactions with the preceptor), and; (iii) the Doctor–System Interaction (financial issues; doctor–system issues; external influences; doctor frustration related to system issues). Everyday ethics issues were explicitly identified by preceptors (without teaching) in 18 of 109 cases (17%); explicit identification and teaching occurred in only 13 cases (12%). CONCLUSIONS In this study a variety of everyday ethics issues were frequently encountered as residents cared for patients. Yet, faculty preceptors infrequently explicitly identified or taught these issues during their interactions with residents. Ethics education is important and residents may regard teaching about the ethics-related issues they actually encounter to be highly relevant. A better understanding of the barriers to teaching is needed in order to promote education about everyday ethics in the out-patient setting. PMID:21649704

An introduction to multiplicity issues in clinical trials: the what, why, when and how.

PubMed

Li, Guowei; Taljaard, Monica; Van den Heuvel, Edwin R; Levine, Mitchell Ah; Cook, Deborah J; Wells, George A; Devereaux, Philip J; Thabane, Lehana

2017-04-01

In clinical trials it is not uncommon to face a multiple testing problem which can have an impact on both type I and type II error rates, leading to inappropriate interpretation of trial results. Multiplicity issues may need to be considered at the design, analysis and interpretation stages of a trial. The proportion of trial reports not adequately correcting for multiple testing remains substantial. The purpose of this article is to provide an introduction to multiple testing issues in clinical trials, and to reduce confusion around the need for multiplicity adjustments. We use a tutorial, question-and-answer approach to address the key issues of why, when and how to consider multiplicity adjustments in trials. We summarize the relevant circumstances under which multiplicity adjustments ought to be considered, as well as options for carrying out multiplicity adjustments in terms of trial design factors including Population, Intervention/Comparison, Outcome, Time frame and Analysis (PICOTA). Results are presented in an easy-to-use table and flow diagrams. Confusion about multiplicity issues can be reduced or avoided by considering the potential impact of multiplicity on type I and II errors and, if necessary pre-specifying statistical approaches to either avoid or adjust for multiplicity in the trial protocol or analysis plan. © The Author 2016; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

A report on older-age bipolar disorder from the International Society for Bipolar Disorders Task Force.

PubMed

Sajatovic, Martha; Strejilevich, Sergio A; Gildengers, Ariel G; Dols, Annemiek; Al Jurdi, Rayan K; Forester, Brent P; Kessing, Lars Vedel; Beyer, John; Manes, Facundo; Rej, Soham; Rosa, Adriane R; Schouws, Sigfried Ntm; Tsai, Shang-Ying; Young, Robert C; Shulman, Kenneth I

2015-11-01

In the coming generation, older adults with bipolar disorder (BD) will increase in absolute numbers as well as proportion of the general population. This is the first report of the International Society for Bipolar Disorder (ISBD) Task Force on Older-Age Bipolar Disorder (OABD). This task force report addresses the unique aspects of OABD including epidemiology and clinical features, neuropathology and biomarkers, physical health, cognition, and care approaches. The report describes an expert consensus summary on OABD that is intended to advance the care of patients, and shed light on issues of relevance to BD research across the lifespan. Although there is still a dearth of research and health efforts focused on older adults with BD, emerging data have brought some answers, innovative questions, and novel perspectives related to the notion of late onset, medical comorbidity, and the vexing issue of cognitive impairment and decline. Improving our understanding of the biological, clinical, and social underpinnings relevant to OABD is an indispensable step in building a complete map of BD across the lifespan. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Psychiatric disorders as vulnerability factors for nicotine addiction: what have we learned from animal models?

PubMed

Le Foll, Bernard; Ng, Enoch; Di Ciano, Patricia; Trigo, José M

2015-01-01

Epidemiological studies indicate a high prevalence of tobacco smoking in subjects with psychiatric disorders. Notably, there is a high prevalence of smoking among those with dependence to other substances, schizophrenia, mood, or anxiety disorders. It has been difficult to understand how these phenomena interact with clinical populations as it is unclear what preceded what in most of the studies. These comorbidities may be best understood by using experimental approaches in well-controlled conditions. Notably, animal models represent advantageous approaches as the parameters under study can be controlled perfectly. This review will focus on evidence collected so far exploring how behavioral effects of nicotine are modified in animal models of psychiatric conditions. Notably, we will focus on behavioral responses induced by nicotine that are relevant for its addictive potential. Despite the clinical relevance and frequency of the comorbidity between psychiatric issues and tobacco smoking, very few studies have been done to explore this issue in animals. The available data suggest that the behavioral and reinforcing effects of nicotine are enhanced in animal models of these comorbidities, although much more experimental work would be required to provide certainty in this domain.

The Relevance of Hispanic Culture to the Treatment of a Patient with Posttraumatic Stress Disorder (PTSD)

PubMed Central

Smith, Christian

2006-01-01

Cahill, et al.1 discussed the importance of psychotherapy and psychotropic medications in the prevention and treatment of acute stress disorder and posttraumatic stress disorder (PTSD) in the September, 2005, issue of Psychiatry. In this article, we will specifically explore PTSD in the Hispanic population and present a composite case to demonstrate several clinical issues to consider when treating this population. This topic is timely and highly relevant to the practice of psychiatry as the Latino population continues to grow at a pace that far exceeds the capability of both current Latino/bilingual psychiatrists and the number of Latinos in the mental health provider pipeline. Given this great disparity, all psychiatrists need to be equipped with knowledge that will enable them to provide culturally sensitive care2 that will result in better Hispanic patient outcomes. PMID:20877547

[Marketing orientation in rehabilitation--exemplified by image analysis of a rehabilitation clinic for addictions].

PubMed

Altenhöner, T; Schönhoff, T; Wehmeier, D

2001-06-01

This article presents the findings of an image analysis carried out for a rehabilitation clinic for addictive diseases. The cross-sectional study was designed as an anonymous survey sent to relevant (regional) referral agencies (n = 90), e.g. counselling services for addictive diseases. The study covers the clinic's actual and ideal image, discriminating frequency of referrals, diagnostic categories, region, and type of institution. Results concerning the real profile indicate that on average the dimensions cooperation, communication with regard to personal contact, and reputation of the clinic were more critically judged than the issues information, communication with regard to discharge reports, standards of quality, and consideration of patients' needs. Cooperation, communication with regard to personal contact, and quality standards turned out to be the most important criteria from the referring agencies' perspective (ideal profile). A statistical comparison between those with high and low assignment rates suggested that customers rated the clinic more favourably than non-customers. Thus, it seems that the clinic's image has considerable influence on referral decisions. Particularly interesting is the additional finding that the referring institutions perceive pension insurers' directives to be of secondary relevance.

Systematic reviews: guidance relevant for studies of older people.

PubMed

Shenkin, Susan D; Harrison, Jennifer K; Wilkinson, Tim; Dodds, Richard M; Ioannidis, John P A

2017-09-01

Systematic reviews and meta-analyses are increasingly common. This article aims to provide guidance for people conducting systematic reviews relevant to the healthcare of older people. An awareness of these issues will also help people reading systematic reviews to determine whether the results will influence their clinical practice. It is essential that systematic reviews are performed by a team which includes the required technical and clinical expertise. Those performing reviews for the first time should ensure they have appropriate training and support. They must be planned and performed in a transparent and methodologically robust way: guidelines are available. The protocol should be written-and if possible published-before starting the review. Geriatricians will be interested in a table of baseline characteristics, which will help to determine if the studied samples or populations are similar to their patients. Reviews of studies of older people should consider how they will manage issues such as different age cut-offs; non-specific presentations; multiple predictors and outcomes; potential biases and confounders. Systematic reviews and meta-analyses may provide evidence to improve older people's care, or determine where new evidence is required. Newer methodologies, such as meta-analyses of individual level data, network meta-analyses and umbrella reviews, and realist synthesis, may improve the reliability and clinical utility of systematic reviews. © The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society.

In vivo diagnosis of allergic diseases--allergen provocation tests.

PubMed

Agache, I; Bilò, M; Braunstahl, G-J; Delgado, L; Demoly, P; Eigenmann, P; Gevaert, P; Gomes, E; Hellings, P; Horak, F; Muraro, A; Werfel, T; Jutel, M

2015-04-01

The allergen challenge test has been the mainstay of diagnosis of allergic diseases for a long time since it offers a direct proof of the clinical relevance of a particular allergen for the allergic disease symptoms and severity. Standardisation and availability for daily practice (including safety issues) are still to be refined but most of the challenge tests have safely crossed the border from research tools to diagnostic tests available for daily practice for a well trained clinical staff. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

PM101: intravenous amiodarone formulation changes can improve medication safety.

PubMed

Souney, Paul F; Cooper, Warren D; Cushing, Daniel J

2010-03-01

Intravenous amiodarone (A-IV) is used to manage ventricular and atrial arrhythmias. The current formulation uses polysorbate 80 and benzyl alcohol to maintain amiodarone in solution, and these co-solvents are linked with clinically-important adverse events and pharmaceutical incompatibilities. PM101 is a recently FDA-approved intravenous formulation of amiodarone that uses a cyclodextrin to solubilize amiodarone. This review describes the clinical and pharmaceutical development of formulations of amiodarone for intravenous administration. The medical and pharmaceutical literature was searched for papers discussing A-IV, PM101 and their formulation components. Relevant literature was identified starting from 1948 to the present. The reader will learn about the important medical and pharmaceutical issues complicating A-IV administration, including an understanding of related hypotension and compatibility with commonly used infusion materials and how these issues may impact drug safety. PM101 has been developed to address several of these important issues. PM101 is a new formulation of A-IV that is stable in commonly used infusion materials and avoids co-solvent related toxicities.

How Much Is Life Worth: Cetuximab, Non–Small Cell Lung Cancer, and the $440 Billion Question

PubMed Central

Grady, Christine

2009-01-01

The spiraling cost of cancer care, in particular the cost of cancer therapeutics that achieve only marginal benefits, is under increasing scrutiny. Although health-care professionals avoid putting a value on a life, our limited resources require that society address what counts as a benefit, the extent to which cost should factor in deliberations, and who should be involved in these decisions. Professional societies, such as the American Society of Clinical Oncology, government agencies, including the Food and Drug Administration, and insurance companies should be involved. However, no segment of society is better qualified to address these issues than the oncology community. Oncologists must offer clear guidance for the conduct of research, interpretation of results, and prescription of chemotherapies. We review recent drug approvals and clinical trials and comment on their relevance to the issue of the spiraling cost of oncology therapeutics. We suggest some standards that would serve as a starting point for addressing these issues. PMID:19564563

The role of boldness in psychopathy: A study of academic and clinical perceptions.

PubMed

Berg, Joanna M; Lilienfeld, Scott O; Sellbom, Martin

2017-10-01

The relevance of boldness to psychopathy has recently become a major flashpoint of scientific controversy. Although some authors have contended that boldness is a necessary (although insufficient) component of psychopathy, others have asserted that it is largely or entirely irrelevant to psychopathy. We addressed this issue by examining clinical perceptions of the relevance of the 3 triarchic dimensions (boldness, disinhibition, and meanness) to psychopathy among a sample of mental health professionals and graduate students (N = 228) using a vignette-based, person-centered methodology. A vignette comprising boldness descriptors afforded statistically significant and moderate to large (Cohen's ds ranged from .47 to .99) increases in perceived resemblance to overall psychopathy above and beyond the other triarchic dimensions, both singly and jointly; these findings extended largely to clinical perceptions of Factor 1 (i.e., interpersonal and affective aspects of psychopathy) but not Factor 2 (i.e., impulsive and antisocial aspects of psychopathy) resemblance. Contrary to the claims of some recent authors, boldness alone was perceived as being as relevant to psychopathy as was disinhibition, although both dimensions were perceived as less relevant to psychopathy than was meanness. These findings offer strong support for the contention that boldness is regarded as a key feature of classical psychopathy and are broadly consistent with interpersonal models of psychopathy. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Fundamental dilemmas in contemporary psychotherapy: a transtheoretical concept.

PubMed

Scaturo, Douglas J

2002-01-01

The transtheoretical nature of fundamental dilemmas in contemporary psychotherapy is explored. The basic distinction between technical and ethical dilemmas in clinical practice is discussed, as well as the ramifications for the psychotherapist. Clinical dilemmas identified by survey research studies and interviews with master psychotherapists are reviewed. In addition to dilemmas relevant to circumscribed areas of psychotherapy, such as brief therapy, managed mental health care, sexual questions, feminist therapy, dilemmas fundamental to the psychotherapeutic process as a whole are examined. Finally, clinical examples are provided that include such issues as hospitalization of the suicidal patient, dealing with known contraindications, treating the intractable patient, and self-care of the psychotherapist.

Basics of Compounding: Clinical Pharmaceutics, Part 1.

PubMed

Allen, Loyd V

2016-01-01

Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Pharmacy is unique as it contains a knowledge base significantly different from that of physicians, nurses, and other health-related practitioners. The separation of the science and the practice of pharmacy have prevented the complete utilization of pharmaceutical sciences in the clinical environment far too long. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Portal vein thrombosis in patients with cirrhosis

PubMed Central

von Köckritz, Leona; De Gottardi, Andrea; Praktiknjo, Michael

2017-01-01

Abstract Portal vein thrombosis (PVT) is frequent in patients with liver cirrhosis and possible severe complications such as mesenteric ischemia are rare, but can be life-threatening. However, different aspects of clinical relevance, diagnosis and management of PVT are still areas of uncertainty and investigation in international guidelines. In this article, we elaborate on PVT classification, geographical differences in clinical presentation and standards of diagnosis, and briefly on the current pathophysiological understanding and risk factors. This review considers and highlights the pitfalls of the various treatment approaches and prophylactic treatments. Finally, we review the controversial issue of clinical impact of PVT on prognosis, especially considering liver transplantation and future perspectives. PMID:28533912

HTA and its legal issues: a framework for identifying legal issues in health technology assessment.

PubMed

Widrig, Daniel; Tag, Brigitte

2014-12-01

Legal analysis can highlight important issues that are relevant when deciding whether a medical technology should be implemented or reimbursed. Literature and studies show that even though the law is an acknowledged part of health technology assessment (HTA), legal issues are rarely considered in practice. One reason for this may be the lack of knowledge about the diversity of legal issues that are relevant for HTA. Therefore, this contribution aims primarily to identify and then explain the relevant legal issues in HTA. This study offers a framework for identifying the legal issues in HTAs in different jurisdictions and provides a basis for further research. After extensive literature search, the authors review Swiss health law to identify legal issues that are relevant to HTA. The authors then categorize these legal issues using a framework with an inside and outside perspective. Finally, they explain a selection of these legal issues with several examples. This study reveals numerous legal issues that are relevant for HTA and underlines the necessity of incorporating legal analysis in HTAs. The suggested perspectival framework in this study provides a basis to structure the legal analysis. The identified legal issues are relevant in other countries and the perspectival framework is transferable to other jurisdictions. The article underlines the importance of in-depth discussion about the role of law in HTA. It provides a structured overview of the legal issues in HTA and suggests a development of more concrete instruments toward a standardized legal technology assessment.

Biomarkers for AAA: Encouraging steps but clinical relevance still to be delivered.

PubMed

Htun, Nay Min; Peter, Karlheinz

2014-10-01

Potential biomarkers have been investigated using proteomic studies in a variety of diseases. Some biomarkers have central roles in both diagnosis and monitoring of various disorders in clinical medicine, such as troponins, brain natriuretic peptide, and C-reactive protein. Although several biomarkers have been suggested in human abdominal aortic aneurysm (AAA), reliable markers have been lacking. In this issue, Moxon et al. [Proteomics Clin Appl. 2014, 8, 762-772] undertook a broad and systematic proteomic approach toward identification of biomarkers in a commonly used AAA mouse model (AAA created by angiotensin-II infusion). In this mouse model, apolipoprotein C1 and matrix metalloproteinase-9 were identified as novel biomarkers of stable AAA. This finding represents an important step forward, toward a clinically relevant role of biomarkers in AAA. This also encourages for further studies toward the identification of biomarkers (or their combinations) that can predict AAA progression and rupture, which would represent a major progress in AAA management and would establish an AAA biomarker as a much anticipated clinical tool. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Exploring the Topics Discussed During a Conversation Card Game About Death and Dying: A Content Analysis.

PubMed

Van Scoy, Lauren Jodi; Reading, Jean M; Scott, Allison M; Chuang, Cynthia; Levi, Benjamin H; Green, Michael J

2016-11-01

Substantive discussions between loved ones are necessary for effective advance care planning. Although multiple tools are currently in use for promoting conversations, the content and clinical relevance of the conversations they stimulate is unknown. To describe the content and clinical relevance of conversations that occur during a nonfacilitated end-of-life conversation game. Using convenience sampling, we scheduled adult volunteers to participate in an end-of-life conversation game (2-6 individuals per game; n = 68). Participants discussed 20 questions about death, dying, or end-of-life issues. Games lasted up to two hours and were audio-recorded, transcribed, and analyzed using a conventional qualitative content analysis approach to identify emerging themes. Participants (n = 68) were primarily Caucasian (94%), females (68%), with mean age of 51.3 years (SD 0.7). Seventeen games were analyzed. Four primary themes emerged during game conversations: 1) the importance of people, relationships, and the roles played during end-of-life decision making, 2) values, beliefs, and preferences related to end-of-life care and the dying period, 3) considerations about preparing for the aftermath of one's death, and 4) the relevance of stories or experiences for informing one's own end-of-life preferences. Topics discussed during a nonfacilitated end-of-life conversation game are substantive and address important issues for advance care planning. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Team-based efforts to improve quality of care, the fundamental role of ethics, and the responsibility of health managers: monitoring and management strategies to enhance teamwork.

PubMed

Kossaify, A; Hleihel, W; Lahoud, J-C

2017-12-01

Highlight the importance of teamwork in health care institutions by performing a review and discussion of the relevant literature. Review paper. A MEDLINE/Pubmed search was performed starting from 1990, and the terms 'team, teamwork, managers, healthcare, and cooperation' were searched in titles, abstracts, keywords, and conclusions; other terms 'patient safety, ethics, audits and quality of care' were specifically searched in abstracts and were used as additional filters criteria to select relevant articles. Thirty-three papers were found relevant; factors affecting the quality of care in health care institutions are multiple and varied, including issues related to individual profile, to administrative structure and to team-based effort. Issues affecting teamwork include mainly self-awareness, work environment, leadership, ethics, cooperation, communication, and competition. Moreover, quality improvement plans aiming to enhance and expand teams are essential in this context. Team monitoring and management are vital to achieve efficient teamwork with all the required qualities for a safer health system. In all cases, health managers' responsibility plays a fundamental role in creating and sustaining a teamwork atmosphere. Teamwork is known to improve outcomes in medicine, whether at the clinical, organizational, or scientific level. Teamwork in health care institutions must increasingly be encouraged, given that individual effort is often insufficient for optimal clinical outcome. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Methodological issues in the choice among different drugs approved for the same therapeutic indication: a position paper by the Italian Association of Medical Oncology (AIOM)

PubMed Central

Bruzzi, Paolo; Perrone, Francesco; Torri, Valter; Montemurro, Filippo; Tiseo, Marcello; Vasile, Enrico

2016-01-01

In oncology, as in other clinical fields, different treatments are often approved for the same therapeutic indication. In many cases, no direct comparisons are available to inform the choice in clinical practice. In 2015, the Italian Association of Medical Oncology (AIOM) instructed a working group, including both clinicians and methodologists, to discuss the issue of the best choice among different treatments available for the same indication. The working group discussed 3 different scenarios: (1) biosimilar drugs; (2) different drugs with same mechanism of action; (3) different drugs with different mechanism of action. For each scenario, methodological issues were discussed, along with the priority for investment of resources in the conduct of clinical trials testing direct comparison. As for biosimilar drugs, the panel recommended that, following comparability exercise and approval by regulatory agencies, they should be widely used, considered that their use allows financial savings. As for different drugs (with either the same or a different mechanism of action), the panel agreed that indirect comparisons and network meta-analyses are associated with relevant risk of bias and imprecision, and direct comparisons should be encouraged. The priority of these direct comparisons should be higher when the potential differences in efficacy and/or toxicity are clinically relevant. The choice of the study design (superiority vs non-inferiority) depends on the toxicity profiles and also on the presumed difference in efficacy. Scientific societies should put pressure on public bodies to identify all the administrative and financial mechanisms useful to facilitate the conduct of trials testing direct comparisons, when needed. Decision about therapeutic equivalence can have important consequences on innovation: the availability of drugs characterised by the same effectiveness, but at a lower cost, could enable non-negligible savings of economic resources that could be used to guarantee access to innovative, high-cost drugs. PMID:28255452

Methodological issues in the choice among different drugs approved for the same therapeutic indication: a position paper by the Italian Association of Medical Oncology (AIOM).

PubMed

Di Maio, Massimo; Bruzzi, Paolo; Perrone, Francesco; Torri, Valter; Montemurro, Filippo; Tiseo, Marcello; Vasile, Enrico

2016-01-01

In oncology, as in other clinical fields, different treatments are often approved for the same therapeutic indication. In many cases, no direct comparisons are available to inform the choice in clinical practice. In 2015, the Italian Association of Medical Oncology (AIOM) instructed a working group, including both clinicians and methodologists, to discuss the issue of the best choice among different treatments available for the same indication. The working group discussed 3 different scenarios: (1) biosimilar drugs; (2) different drugs with same mechanism of action; (3) different drugs with different mechanism of action. For each scenario, methodological issues were discussed, along with the priority for investment of resources in the conduct of clinical trials testing direct comparison. As for biosimilar drugs, the panel recommended that, following comparability exercise and approval by regulatory agencies, they should be widely used, considered that their use allows financial savings. As for different drugs (with either the same or a different mechanism of action), the panel agreed that indirect comparisons and network meta-analyses are associated with relevant risk of bias and imprecision, and direct comparisons should be encouraged. The priority of these direct comparisons should be higher when the potential differences in efficacy and/or toxicity are clinically relevant. The choice of the study design (superiority vs non-inferiority) depends on the toxicity profiles and also on the presumed difference in efficacy. Scientific societies should put pressure on public bodies to identify all the administrative and financial mechanisms useful to facilitate the conduct of trials testing direct comparisons, when needed. Decision about therapeutic equivalence can have important consequences on innovation: the availability of drugs characterised by the same effectiveness, but at a lower cost, could enable non-negligible savings of economic resources that could be used to guarantee access to innovative, high-cost drugs.

Standards for the Psychosocial Care of Children With Cancer and Their Families: An Introduction to the Special Issue | Center for Cancer Research

Cancer.gov

Pediatric oncology psychosocial professionals collaborated with an interdisciplinary group of experts and stakeholders and developed evidence-based standards for pediatric psychosocial care. Given the breadth of research evidence and traditions of clinical care, 15 standards were derived. Each standard is based on a systematic review of relevant literature and used the AGREE

BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.

PubMed

Bruzzi, M S; Linehan, J H

2013-09-01

In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners.

Integrative dimensions of psychotherapy training.

PubMed

Greben, Daniel H

2004-04-01

This paper investigates the influence of integrative factors on psychotherapy education. The broad relevance of integrative psychotherapy to residency training and continuing mental health education is discussed. Following a review of the existing literature on the education of integrative psychotherapists, the article systematically examines the integrative and pedagogic issues to be considered in planning psychotherapy training informed by integrative principles. The integrative issues are organized into 5 categories: attitudinal set, knowledge base, clinical techniques and skills, developmental tasks and challenges, and systemic institutional factors. The educational issues can be divided into 4 categories: content, format and process, sequence, and faculty development. Brief descriptions of actual educational interventions illustrate the implementation of such ideas. Specific recommendations are made regarding the development of integrative educational initiatives and future study of unresolved questions.

Maintaining Sexual Health throughout Gynecologic Cancer Survivorship: A Comprehensive Review and Clinical Guide

PubMed Central

Huffman, Laura B.; Hartenbach, Ellen M.; Carter, Jeanne; Rash, Joanne K.; Kushner, David M.

2016-01-01

Objective The diagnosis and treatment of gynecologic cancer can cause short- and long-term negative effects on sexual health and quality of life (QoL). The aim of this article is to present a comprehensive overview of the sexual health concerns of gynecologic cancer survivors and discuss evidence-based treatment options for commonly encountered sexual health issues. Methods A comprehensive literature search of English language studies on sexual health in gynecologic cancer survivors and the treatment of sexual dysfunction was conducted in MEDLINE databases. Relevant data are presented in this review. Additionally, personal and institutional practices are incorporated where relevant. Results Sexual dysfunction is prevalent among gynecologic cancer survivors as a result of surgery, radiation, and chemotherapy--negatively impacting QoL. Many patients expect their healthcare providers to address sexual health concerns, but most have never discussed sex-related issues with their physician. Lubricants, moisturizers, and dilators are effective, simple, non-hormonal interventions that can alleviate the morbidity of vaginal atrophy, stenosis, and pain. Pelvic floor physical therapy can be an additional tool to address dyspareunia. Cognitive behavioral therapy has been shown to be beneficial to patients reporting problems with sexual interest, arousal, and orgasm. Conclusion Oncology providers can make a significant impact on the QoL of gynecologic cancer survivors by addressing sexual health concerns. Simple strategies can be implemented into clinical practice to discuss and treat many sexual issues. Referral to specialized sexual health providers may be needed to address more complex problems. PMID:26556768

A Conceptual Model of the Information Requirements of Nursing Organizations

PubMed Central

Miller, Emmy

1989-01-01

Three related issues play a role in the identification of the information requirements of nursing organizations. These issues are the current state of computer systems in health care organizations, the lack of a well-defined data set for nursing, and the absence of models representing data and information relevant to clinical and administrative nursing practice. This paper will examine current methods of data collection, processing, and storage in clinical and administrative nursing practice for the purpose of identifying the information requirements of nursing organizations. To satisfy these information requirements, database technology can be used; however, a model for database design is needed that reflects the conceptual framework of nursing and the professional concerns of nurses. A conceptual model of the types of data necessary to produce the desired information will be presented and the relationships among data will be delineated.

A data-driven approach to quality risk management

PubMed Central

Alemayehu, Demissie; Alvir, Jose; Levenstein, Marcia; Nickerson, David

2013-01-01

Aim: An effective clinical trial strategy to ensure patient safety as well as trial quality and efficiency involves an integrated approach, including prospective identification of risk factors, mitigation of the risks through proper study design and execution, and assessment of quality metrics in real-time. Such an integrated quality management plan may also be enhanced by using data-driven techniques to identify risk factors that are most relevant in predicting quality issues associated with a trial. In this paper, we illustrate such an approach using data collected from actual clinical trials. Materials and Methods: Several statistical methods were employed, including the Wilcoxon rank-sum test and logistic regression, to identify the presence of association between risk factors and the occurrence of quality issues, applied to data on quality of clinical trials sponsored by Pfizer. Results: Only a subset of the risk factors had a significant association with quality issues, and included: Whether study used Placebo, whether an agent was a biologic, unusual packaging label, complex dosing, and over 25 planned procedures. Conclusion: Proper implementation of the strategy can help to optimize resource utilization without compromising trial integrity and patient safety. PMID:24312890

Ethical Considerations in Tissue Engineering Research: Case Studies in Translation

PubMed Central

Baker, Hannah B.; McQuilling, John P.

2016-01-01

Tissue engineering research is a complex process that requires investigators to focus on the relationship between their research and anticipated gains in both knowledge and treatment improvements. The ethical considerations arising from tissue engineering research are similarly complex when addressing the translational progression from bench to bedside, and investigators in the field of tissue engineering act as moral agents at each step of their research along the translational pathway, from early benchwork and preclinical studies to clinical research. This review highlights the ethical considerations and challenges at each stage of research, by comparing issues surrounding two translational tissue engineering technologies: the bioartificial pancreas and a tissue engineered skeletal muscle construct. We present relevant ethical issues and questions to consider at each step along the translational pathway, from the basic science bench to preclinical research to first-in-human clinical trials. Topics at the bench level include maintaining data integrity, appropriate reporting and dissemination of results, and ensuring that studies are designed to yield results suitable for advancing research. Topics in preclinical research include the principle of “modest translational distance” and appropriate animal models. Topics in clinical research include key issues that arise in early-stage clinical trials, including selection of patient-subjects, disclosure of uncertainty, and defining success. The comparison of these two technologies and their ethical issues brings to light many challenges for translational tissue engineering research and provides guidance for investigators engaged in development of any tissue engineering technology. PMID:26282436

Ethical considerations in tissue engineering research: Case studies in translation.

PubMed

Baker, Hannah B; McQuilling, John P; King, Nancy M P

2016-04-15

Tissue engineering research is a complex process that requires investigators to focus on the relationship between their research and anticipated gains in both knowledge and treatment improvements. The ethical considerations arising from tissue engineering research are similarly complex when addressing the translational progression from bench to bedside, and investigators in the field of tissue engineering act as moral agents at each step of their research along the translational pathway, from early benchwork and preclinical studies to clinical research. This review highlights the ethical considerations and challenges at each stage of research, by comparing issues surrounding two translational tissue engineering technologies: the bioartificial pancreas and a tissue engineered skeletal muscle construct. We present relevant ethical issues and questions to consider at each step along the translational pathway, from the basic science bench to preclinical research to first-in-human clinical trials. Topics at the bench level include maintaining data integrity, appropriate reporting and dissemination of results, and ensuring that studies are designed to yield results suitable for advancing research. Topics in preclinical research include the principle of "modest translational distance" and appropriate animal models. Topics in clinical research include key issues that arise in early-stage clinical trials, including selection of patient-subjects, disclosure of uncertainty, and defining success. The comparison of these two technologies and their ethical issues brings to light many challenges for translational tissue engineering research and provides guidance for investigators engaged in development of any tissue engineering technology. Copyright © 2015 Elsevier Inc. All rights reserved.

Basics of Compounding: Clinical Pharmaceutics, Part 2.

PubMed

Allen, Loyd V

2016-01-01

This article represents part 2 of a 2-part article on the topic of clinical pharmaceutics. Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Part 1 of this series of articles discussed incompatibilities which can directly affect a clinical outcome and utilized pharmaceutics case examples of the application and importance of clinical pharmaceutics covering different characteristics. Part 2 continues to illustrate the scientific principles and clinical effects involved in clinical pharmaceutics. Also covered in this article are many of the scientific principles in typical to patient care. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Facilitating access to pre-processed research evidence in public health

PubMed Central

2010-01-01

Background Evidence-informed decision making is accepted in Canada and worldwide as necessary for the provision of effective health services. This process involves: 1) clearly articulating a practice-based issue; 2) searching for and accessing relevant evidence; 3) appraising methodological rigor and choosing the most synthesized evidence of the highest quality and relevance to the practice issue and setting that is available; and 4) extracting, interpreting, and translating knowledge, in light of the local context and resources, into practice, program and policy decisions. While the public health sector in Canada is working toward evidence-informed decision making, considerable barriers, including efficient access to synthesized resources, exist. Methods In this paper we map to a previously developed 6 level pyramid of pre-processed research evidence, relevant resources that include public health-related effectiveness evidence. The resources were identified through extensive searches of both the published and unpublished domains. Results Many resources with public health-related evidence were identified. While there were very few resources dedicated solely to public health evidence, many clinically focused resources include public health-related evidence, making tools such as the pyramid, that identify these resources, particularly helpful for public health decisions makers. A practical example illustrates the application of this model and highlights its potential to reduce the time and effort that would be required by public health decision makers to address their practice-based issues. Conclusions This paper describes an existing hierarchy of pre-processed evidence and its adaptation to the public health setting. A number of resources with public health-relevant content that are either freely accessible or requiring a subscription are identified. This will facilitate easier and faster access to pre-processed, public health-relevant evidence, with the intent of promoting evidence-informed decision making. Access to such resources addresses several barriers identified by public health decision makers to evidence-informed decision making, most importantly time, as well as lack of knowledge of resources that house public health-relevant evidence. PMID:20181270

Combining the ‘bottom up’ and ‘top down’ approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data

PubMed Central

Tsamandouras, Nikolaos; Rostami-Hodjegan, Amin; Aarons, Leon

2015-01-01

Pharmacokinetic models range from being entirely exploratory and empirical, to semi-mechanistic and ultimately complex physiologically based pharmacokinetic (PBPK) models. This choice is conditional on the modelling purpose as well as the amount and quality of the available data. The main advantage of PBPK models is that they can be used to extrapolate outside the studied population and experimental conditions. The trade-off for this advantage is a complex system of differential equations with a considerable number of model parameters. When these parameters cannot be informed from in vitro or in silico experiments they are usually optimized with respect to observed clinical data. Parameter estimation in complex models is a challenging task associated with many methodological issues which are discussed here with specific recommendations. Concepts such as structural and practical identifiability are described with regards to PBPK modelling and the value of experimental design and sensitivity analyses is sketched out. Parameter estimation approaches are discussed, while we also highlight the importance of not neglecting the covariance structure between model parameters and the uncertainty and population variability that is associated with them. Finally the possibility of using model order reduction techniques and minimal semi-mechanistic models that retain the physiological-mechanistic nature only in the parts of the model which are relevant to the desired modelling purpose is emphasized. Careful attention to all the above issues allows us to integrate successfully information from in vitro or in silico experiments together with information deriving from observed clinical data and develop mechanistically sound models with clinical relevance. PMID:24033787

Breech presentation: an audit project as means of pursuing clinical excellence.

PubMed

Siassakos, D; Anderson, H; Panter, K

2005-10-01

Clinical audit is an effective quality improvement process to evaluate important clinical issues. Breech presentation is such an issue due to its contribution to the rising caesarean section (CS) rate. We set out to assess the management of breech presentation using, as standards, the delivery suite protocol and national guidelines. Our first audit revealed a low success rate of external cephalic version (ECV) and deficient documentation of written consent for ECV, other aspects of care being satisfactory. The results were presented to a multidisciplinary meeting and disseminated to relevant stakeholders. A re-audit was then performed. It confirmed significant improvement in the documentation of consent for ECV. It also revealed a good detection rate of breech, optimal offer rate of ECV and good neonatal outcome. However, uptake of ECV as well as the success rate could both be improved so as to reduce the CS rate for breech presentation. We discuss options for improving the uptake and success rate for ECV.

Carcinoma of unknown primary: key radiological issues from the recent National Institute for Health and Clinical Excellence guidelines

PubMed Central

Taylor, M B; Bromham, N R; Arnold, S E

2012-01-01

Carcinoma of unknown primary origin (CUP) accounts for 3–5% of cancer cases and is the fourth most common cause of cancer death in the UK. CUP management is challenging, partly owing to the heterogeneity of the condition and its presentation, but also owing to the lack of dedicated clinical services for these patients. The recent National Institute for Health and Clinical Excellence (NICE) guidelines on metastatic malignancy of unknown primary origin were developed to improve the co-ordination of diagnostic and clinical services at hospitals treating cancer patients in England and Wales, in particular by the setting up of CUP teams to manage these patients. Radiologists have a vital role in the diagnosis of these patients and should work closely with the CUP team to streamline the diagnostic pathway. This article summarises areas of the NICE guidelines relevant to radiology and discusses the radiological management of patients with CUP, including initial investigation, the importance of biopsy, the management of specific presentations, special investigations and organisational issues. PMID:22374278

Is it time to introduce repetitive transcranial magnetic stimulation into standard clinical practice for the treatment of depressive disorders?

PubMed

Fitzgerald, Paul

2003-02-01

To examine issues relating to the potential introduction of repetitive transcranial magnetic stimulation (rTMS) into clinical practice as a treatment for depression. A review of the outcomes literature accompanied by an analysis of issues relating to the potential advantages and pitfalls of the introduction of rTMS as a treatment strategy. Evidence is progressively accumulating that rTMS has antidepressant properties that are clinically relevant. These effects are biologically plausible and supported by basic research. Patients with therapy-resistant depression have few treatment alternatives and experience significant suffering, thus justifying the early introduction of a new treatment such as rTMS for this patient group. However, this must be balanced by a need to foster considerable further research and not to raise expectations unreasonably. It is timely for rTMS to be made more available to patients with treatment-resistant mood disorders. This need not be limited to clinical research trials but should only occur in medical settings where continual evaluation and research is conducted.

Pharmacogenomics in type II diabetes mellitus management: Steps toward personalized medicine

PubMed Central

Avery, Peter; Mousa, Shaymaa S; Mousa, Shaker A

2009-01-01

Advances in genotype technology in the last decade have put the pharmacogenomics revolution at the forefront of future medicine in clinical practice. Discovery of novel gene variations in drug transporters, drug targets, effector proteins and metabolizing enzymes in the form of single-nucleotide polymorphisms (SNPs) continue to provide insight into the biological phenomena that govern drug efficacy and toxicity. To date, novel gene discoveries extracted from genome-wide association scans and candidate gene studies in at least four antidiabetic drug classes have helped illuminate possible causes of interindividual variability in response. Inadequate protocol guidelines for pharmacogenomics studies often leads to poorly designed studies, making it hard to formulate a definitive conclusion regarding the clinical relevance of the information at hand. These issues, along with the ethical, social, political, legislative, technological, and economic challenges associated with pharmacogenomics have only delayed its entry to mainstream clinical practice. On the other hand, these issues are being actively pursued and rapid progress is being made in each area which assures the possibility of gaining widespread acceptance in clinical practice. PMID:23226037

Depression in female adolescents: an IPA analysis.

PubMed

Shaw, Samantha K; Dallos, Rudi; Shoebridge, Philip

2009-04-01

Six female adolescents participated in open-ended interviews regarding their experiences of depression. The transcripts of their interviews were explored using Interpretative Phenomenological Analysis (Smith, 1991). The analysis revealed three inter-connected super-ordinate themes which were: communication, hurt self, and difference. These themes centred on communication processes in participants' families and with peers, issues relating to shifts in identity through adolescence, and feelings of being damaged, distressed, and hurt. Amongst a range of potentially relevant perspectives, an attachment theory (Bowlby, 1969) orientation was found to be particularly relevant and helpful in interpreting the themes that captured these young women's experiences. Some implications for clinical practice are discussed.

Shared decision making: relevant concepts and facilitating strategies.

PubMed

Bae, Jong-Myon

2017-01-01

As the paradigm in healthcare nowadays is the evidence-based, patient-centered decision making, the issue of shared decision making (SDM) is highlighted. The aims of this manuscript were to look at the relevant concepts and suggest the facilitating strategies for overcoming barriers of conducting SDM. While the definitions of SDM were discordant, several concepts such as good communication, individual autonomy, patient participants, and patient-centered decision-making were involved. Further, the facilitating strategies of SDM were to educate and train physician, to apply clinical practice guidelines and patient decision aids, to develop valid measurement tools for evaluation of SDM processes, and to investigate the impact of SDM.

Manualized treatment programs for FSD: research challenges and recommendations.

PubMed

Hucker, Alice; McCabe, Marita P

2012-02-01

The use of manualized treatment programs offers a useful research framework for assessing psychotherapeutic interventions for female sexual dysfunctions (FSDs), but it does not address all issues related to methodological rigor and replication, and raises new research issues in need of discussion. The goals of this manuscript are to review the literature on treatment trials utilizing manualized psychotherapy treatments for FSD and to explore the benefits and research issues associated with the flexible use of treatment manuals. The method used was the review of the relevant literature. While the use of manualized treatments for FSDs can address certain methodological issues inherent in psychotherapy research, flexibility in manual administration is necessary in order to allow tailoring for individual needs that can be beneficial to both the participant and the research. The flexible use of manuals, as opposed to strict manual adherence, may also be more relevant for clinical utility. In order to administer manualized treatments for FSDs with appropriate flexibility, while also maximizing internal validity and replicability, the authors recommend that predetermined decision rules be utilized to guide individual tailoring, that potential gaps in the manual be identified and addressed, and that differing levels of motivation and readiness for treatment be taken into consideration in the treatment protocol. © 2011 International Society for Sexual Medicine.

Sexual behavior that is "out of control": a theoretical conceptual approach.

PubMed

Bancroft, John

2008-12-01

At this stage of our knowledge, it seems reasonable to assume that out-of-control sexual behavior results from a variety of etiological mechanisms associated with different behavioral patterns that share Goodman's two key features of addictive behavior: (1) a recurrent failure to control the sexual behavior; and (2) continuation of the behavior despite harmful consequences. Any overriding definition relevant to clinical management seems premature until we better understand the various patterns and their likely determinants. The concepts of "compulsivity" and "addiction" may have explanatory value in some cases, but are not helpful when used as general terms for this class of behavior problem. Stein and colleagues suggested that, in these circumstances, we use the term "hypersexuality." In my opinion, out-of-control sexual behavior or "impulse control disorders" as proposed by Barth and Kinder are more appropriate nonspecific terms because they focus on the issue of control rather than on high levels of sexuality. A number of clinically relevant and researchable hypotheses need to be addressed in further research, which hopefully will lead to more etiologically or therapeutically relevant subcategories of out-of-control sexual behavior.

A knowledge engineering framework towards clinical support for adverse drug event prevention: the PSIP approach.

PubMed

Koutkias, Vassilis; Stalidis, George; Chouvarda, Ioanna; Lazou, Katerina; Kilintzis, Vassilis; Maglaveras, Nicos

2009-01-01

Adverse Drug Events (ADEs) are currently considered as a major public health issue, endangering patients' safety and causing significant healthcare costs. Several research efforts are currently concentrating on the reduction of preventable ADEs by employing Information Technology (IT) solutions, which aim to provide healthcare professionals and patients with relevant knowledge and decision support tools. In this context, we present a knowledge engineering approach towards the construction of a Knowledge-based System (KBS) regarded as the core part of a CDSS (Clinical Decision Support System) for ADE prevention, all developed in the context of the EU-funded research project PSIP (Patient Safety through Intelligent Procedures in Medication). In the current paper, we present the knowledge sources considered in PSIP and the implications they pose to knowledge engineering, the methodological approach followed, as well as the components defining the knowledge engineering framework based on relevant state-of-the-art technologies and representation formalisms.

Addressing incontinence for people with dementia living at home: a documentary analysis of local English community nursing service continence policies and clinical guidance.

PubMed

Drennan, Vari M; Norrie, Caroline; Cole, Laura; Donovan, Sheila

2013-02-01

To establish whether the problems and issues experienced by people with dementia living at home and their carers were addressed in the clinical guidance for continence management for community nursing services in England. Internationally, the numbers of people with dementia are rising. Managing incontinence is a significant issue as the presence of incontinence is one of the triggers for people with dementia to move their residence to a care home. People with dementia living at home and their family carers report difficulties in accessing knowledgeable professionals and acceptable continence products. A review by documentary analysis of clinical policies and guidance from a sample of community nursing services in all Strategic Health Authority regions of England. A sample of clinical policy and guidance documents for continence assessment and management from up to four community nursing services in each of the ten Strategic Health Authority regions in England was sought. Documentary analysis was undertaken on the relevance of the documents identified for people with dementia living at home. Ninety-eight documents from 38 local community nursing services spread across ten Strategic Health Authority areas were obtained and analysed. Only in the documents of three services were nurses offered detailed guidance about the management of incontinence for people with dementia at home. In the documentation of only one service were people with dementia identified as a special case which warranted the provision of additional continence products. Clinical guidance on continence assessment and management for community nurses in many parts of England does not address the specific needs of people with dementia living at home or their carers. Nurses working in community settings and those providing clinical leadership in continence care should review their clinical guidance and policies to ensure relevance for people with dementia living at home and their family carers. © 2012 Blackwell Publishing Ltd.

'Mind the gap' between the development of therapeutic innovations and the clinical practice in oncology: A proposal of the European Organisation for Research and Treatment of Cancer (EORTC) to optimise cancer clinical research.

PubMed

Kempf, Emmanuelle; Bogaerts, Jan; Lacombe, Denis; Liu, Lifang

2017-11-01

In Europe, most of the cancer clinical research dedicated to therapeutic innovations aims primarily at regulatory approval. Once an anticancer drug enters the common market, each member state determines its real-world use based on its own criteria: pricing, reimbursement and clinical indications. Such an innovation-centred clinical research landscape might neglect patient-relevant issues in real-world setting, such as comparative effectiveness of distinct treatment options or long-term safety monitoring. The European Organisation for Research and Treatment of Cancer (EORTC) advocates reforming the current 'innovation-centred' system to a truly 'patient-centred' paradigm with systematically coordinated applied clinical research in conjunction with drug development, featuring the following strategy. Copyright © 2017 Elsevier Ltd. All rights reserved.

A New Challenge to Research Ethics: Patients-Led Research (PLR) and the Role of Internet Based Social Networks.

PubMed

Lamas, Eugenia; Salinas, Rodrigo; Vuillaume, Dominique

2016-01-01

A characteristic feature of the development of health-related social networks is the emergence of internet-based virtual communities, composed of patients. These communities go beyond the mere interchange of information concerning their conditions, intervening in the planning and execution of clinical research, including randomised controlled trials, in collaboration with health professionals. That was the case, in 2009, when patients suffering amyotrophic lateral sclerosis, a rare and severe disease, conducted a clinical trial in USA, organising themselves through an online platform. This initiative launched a new model for the planning and conduction of clinical research: "Participants-Led Research" (PLR). The distinctive particularities of this new research paradigm represent a challenge to the traditional standards used for judging the ethical soundness of clinical investigation. That is the case, for example, of informed consent. This article aims at identifying the ethical, legal, and social issues (ELSI) posed by PLR and the relevant concepts that may help in solving them. The following issues, in particular, are analysed, that may give place to a new social contract for the ethical assessment of clinical research: consent for participating in research and personal integrity; data protection and confidentiality; benefits sharing and intellectual property.

The role of corruption and unethical behaviour in precluding the placement of industry sponsored clinical trials in sub-Saharan Africa: Stakeholder views.

PubMed

Egharevba, Efe; Atkinson, Jacqueline

2016-08-15

Clinical trials still represent the gold standard in testing the safety and efficacy of new and existing treatments. However, developing regions including sub-Saharan Africa remain underrepresented in pharmaceutical industry sponsored trials for a number of reasons including fear of corruption and unethical behaviour. This fear exists both on the part of pharmaceutical companies, and investigators carrying out research in the region. The objective of this research was to understand the ethical considerations associated with the conduct of pharmaceutical industry sponsored clinical trials in sub-Saharan Africa. Corruption was identified as a significant issue by a number of stakeholders who participated in semi-structured interviews and completed questionnaires. Additionally, fear of being perceived as corrupt or unethical even when conducting ethically sound research was raised as a concern. Thus corruption, whether actual or perceived, is one of a number of issues which have precluded the placement of a greater number of pharmaceutical sponsored clinical trials in this region. More discussion around corruption with all relevant stakeholders is required in order for progress to be made and to enable greater involvement of sub-Saharan African countries in the conduct of industry sponsored clinical trials.

A Cross-site Qualitative Study of Physician Order Entry

PubMed Central

Ash, Joan S.; Gorman, Paul N.; Lavelle, Mary; Payne, Thomas H.; Massaro, Thomas A.; Frantz, Gerri L.; Lyman, Jason A.

2003-01-01

Objective: To describe the perceptions of diverse professionals involved in computerized physician order entry (POE) at sites where POE has been successfully implemented and to identify differences between teaching and nonteaching hospitals. Design: A multidisciplinary team used observation, focus groups, and interviews with clinical, administrative, and information technology staff to gather data at three sites. Field notes and transcripts were coded using an inductive approach to identify patterns and themes in the data. Measurements: Patterns and themes concerning perceptions of POE were identified. Results: Four high-level themes were identified: (1) organizational issues such as collaboration, pride, culture, power, politics, and control; (2) clinical and professional issues involving adaptation to local practices, preferences, and policies; (3) technical/implementation issues, including usability, time, training and support; and (4) issues related to the organization of information and knowledge, such as system rigidity and integration. Relevant differences between teaching and nonteaching hospitals include extent of collaboration, staff longevity, and organizational missions. Conclusion: An organizational culture characterized by collaboration and trust and an ongoing process that includes active clinician engagement in adaptation of the technology were important elements in successful implementation of physician order entry at the institutions that we studied. PMID:12595408

Translating Research on Myoelectric Control into Clinics-Are the Performance Assessment Methods Adequate?

PubMed

Vujaklija, Ivan; Roche, Aidan D; Hasenoehrl, Timothy; Sturma, Agnes; Amsuess, Sebastian; Farina, Dario; Aszmann, Oskar C

2017-01-01

Missing an upper limb dramatically impairs daily-life activities. Efforts in overcoming the issues arising from this disability have been made in both academia and industry, although their clinical outcome is still limited. Translation of prosthetic research into clinics has been challenging because of the difficulties in meeting the necessary requirements of the market. In this perspective article, we suggest that one relevant factor determining the relatively small clinical impact of myocontrol algorithms for upper limb prostheses is the limit of commonly used laboratory performance metrics. The laboratory conditions, in which the majority of the solutions are being evaluated, fail to sufficiently replicate real-life challenges. We qualitatively support this argument with representative data from seven transradial amputees. Their ability to control a myoelectric prosthesis was tested by measuring the accuracy of offline EMG signal classification, as a typical laboratory performance metrics, as well as by clinical scores when performing standard tests of daily living. Despite all subjects reaching relatively high classification accuracy offline, their clinical scores varied greatly and were not strongly predicted by classification accuracy. We therefore support the suggestion to test myocontrol systems using clinical tests on amputees, fully fitted with sockets and prostheses highly resembling the systems they would use in daily living, as evaluation benchmark. Agreement on this level of testing for systems developed in research laboratories would facilitate clinically relevant progresses in this field.

Jewish physicians' beliefs and practices regarding religion/spirituality in the clinical encounter.

PubMed

Stern, Robert M; Rasinski, Kenneth A; Curlin, Farr A

2011-12-01

We used data from a 2003 survey of US physicians to examine differences between Jewish and other religiously affiliated physicians on 4-D of physicians' beliefs and practices regarding religion and spirituality (R/S) in the clinical encounter. On each dimension, Jewish physicians ascribed less importance to the effect of R/S on health and a lesser role for physicians in addressing R/S issues. These effects were partially mediated by lower levels of religiosity among Jewish physicians and by differences in demographic and practice-level characteristics. The study provides a salient example of how religious affiliation can be an important independent predictor of physicians' clinically-relevant beliefs and practices.

Jewish Physicians' Beliefs and Practices Regarding Religion/Spirituality in the Clinical Encounter

PubMed Central

Stern, Robert M.; Rasinski, Kenneth A.; Curlin, Farr A.

2013-01-01

We used data from a 2003 survey of US physicians to examine differences between Jewish and other religiously affiliated physicians on 4-D of physicians' beliefs and practices regarding religion and spirituality (R/S) in the clinical encounter. On each dimension, Jewish physicians ascribed less importance to the effect of R/S on health and a lesser role for physicians in addressing R/S issues. These effects were partially mediated by lower levels of religiosity among Jewish physicians and by differences in demographic and practice-level characteristics. The study provides a salient example of how religious affiliation can be an important independent predictor of physicians' clinically-relevant beliefs and practices. PMID:21706257

Viral hepatitis A, B, and C: grown-up issues.

PubMed

Sharapov, Umid M; Hu, Dale J

2010-08-01

Viral hepatitis is a major global health problem associated with significant morbidity and mortality. Although there are five major and distinct human hepatitis viruses characterized to date--referred to as hepatitis A, B, C, D, and E, respectively--only hepatitis A, B, and C are epidemiologically and clinically relevant for adolescents in North America. The clinical presentation of acute infection with each of these viruses is similar; thus, diagnosis depends on the use of specific serologic markers and viral nucleic acids. This review provides data on the epidemiology, clinical symptoms, diagnosis, treatment, and prevention of each of these three viral infections, along with points that are important or unique to adolescent patients.

Gender identity disorder and autism spectrum disorder in a 23-year-old female.

PubMed

Lemaire, Mathieu; Thomazeau, Barbara; Bonnet-Brilhault, Frédérique

2014-02-01

We describe the case of a 23-year-old woman with Gender Identity Disorder (GID) asking for a cross-sex hormonal treatment with sex reassignment surgery and who was recently diagnosed with Autism Spectrum Disorder (ASD). Gender identity clinics are now reporting an overrepresentation of individuals with ASD among GID patients. The prevalence of ASD is 10-fold higher among GID patients than in general population. However, few case reports or studies have explored the co-occurrence of ASD and GID. This co-occurrence is relevant for diagnostic and clinical management and also raises important theoretical issues.

Children's rights in pediatrics.

PubMed

Streuli, Jürg C; Michel, Margot; Vayena, Effy

2011-01-01

The United Nations Convention of Children's Rights (UNCRC) introduced in 1989 has generated a global movement for the protection of children's rights and has brought about a paradigm change in how children are perceived. Pediatric healthcare professionals are interacting with children and therefore with children's rights on a daily basis. However, although at least 18 of the 54 articles are relevant for pediatric practice, there is limited systematic training on how pediatricians can support children's rights in the clinical setting. This article discusses the principles and aims of the UNCRC and proposes a comprehensive checklist of rights vis-à-vis issues that arise in clinical practice.

Peptides in melanoma therapy.

PubMed

Mocellin, Simone

2012-01-01

Peptides derived from tumor associated antigens can be utilized to elicit a therapeutically effective immune response against melanoma in experimental models. However, patient vaccination with peptides - although it is often followed by the induction of melanoma- specific T lymphocytes - is rarely associated with tumor response of clinical relevance. In this review I summarize the principles of peptide design as well as the results so far obtained in the clinical setting while treating cutaneous melanoma by means of this active immunotherapy strategy. I also discuss some immunological and methodological issues that might be helpful for the successful development of peptide-based vaccines.

Autism genetics: Methodological issues and experimental design.

PubMed

Sacco, Roberto; Lintas, Carla; Persico, Antonio M

2015-10-01

Autism is a complex neuropsychiatric disorder of developmental origin, where multiple genetic and environmental factors likely interact resulting in a clinical continuum between "affected" and "unaffected" individuals in the general population. During the last two decades, relevant progress has been made in identifying chromosomal regions and genes in linkage or association with autism, but no single gene has emerged as a major cause of disease in a large number of patients. The purpose of this paper is to discuss specific methodological issues and experimental strategies in autism genetic research, based on fourteen years of experience in patient recruitment and association studies of autism spectrum disorder in Italy.

To friend or not to friend: the use of social media in clinical oncology.

PubMed

Wiener, Lori; Crum, Caroline; Grady, Christine; Merchant, Melinda

2012-03-01

Online social networking has replaced more traditional methods of personal and professional communication in many segments of society today. The wide reach and immediacy of social media facilitate dissemination of knowledge in advocacy and cancer education, but the usefulness of social media in personal relationships between patients and providers is still unclear. Although professional guidelines regarding e-mail communication may be relevant to social media, the inherent openness in social networks creates potential boundary and privacy issues in the provider-patient context. This commentary seeks to increase provider awareness of unique issues and challenges raised by the integration of social networking into oncology communications.

The role of disease characteristics in the ethical debate on personal genome testing.

PubMed

Bunnik, Eline M; Schermer, Maartje Hn; Janssens, A Cecile J W

2012-01-19

Companies are currently marketing personal genome tests directly-to-consumer that provide genetic susceptibility testing for a range of multifactorial diseases simultaneously. As these tests comprise multiple risk analyses for multiple diseases, they may be difficult to evaluate. Insight into morally relevant differences between diseases will assist researchers, healthcare professionals, policy-makers and other stakeholders in the ethical evaluation of personal genome tests. In this paper, we identify and discuss four disease characteristics--severity, actionability, age of onset, and the somatic/psychiatric nature of disease--and show how these lead to specific ethical issues. By way of illustration, we apply this framework to genetic susceptibility testing for three diseases: type 2 diabetes, age-related macular degeneration and clinical depression. For these three diseases, we point out the ethical issues that are relevant to the question whether it is morally justifiable to offer genetic susceptibility testing to adults or to children or minors, and on what conditions. We conclude that the ethical evaluation of personal genome tests is challenging, for the ethical issues differ with the diseases tested for. An understanding of the ethical significance of disease characteristics will improve the ethical, legal and societal debate on personal genome testing.

A systematic review of methodology applied during preclinical anesthetic neurotoxicity studies: important issues and lessons relevant to the design of future clinical research.

PubMed

Disma, Nicola; Mondardini, Maria C; Terrando, Niccolò; Absalom, Anthony R; Bilotta, Federico

2016-01-01

Preclinical evidence suggests that anesthetic agents harm the developing brain thereby causing long-term neurocognitive impairments. It is not clear if these findings apply to humans, and retrospective epidemiological studies thus far have failed to show definitive evidence that anesthetic agents are harmful to the developing human brain. The aim of this systematic review was to summarize the preclinical studies published over the past decade, with a focus on methodological issues, to facilitate the comparison between different preclinical studies and inform better design of future trials. The literature search identified 941 articles related to the topic of neurotoxicity. As the primary aim of this systematic review was to compare methodologies applied in animal studies to inform future trials, we excluded a priori all articles focused on putative mechanism of neurotoxicity and the neuroprotective agents. Forty-seven preclinical studies were finally included in this review. Methods used in these studies were highly heterogeneous-animals were exposed to anesthetic agents at different developmental stages, in various doses and in various combinations with other drugs, and overall showed diverse toxicity profiles. Physiological monitoring and maintenance of physiological homeostasis was variable and the use of cognitive tests was generally limited to assessment of specific brain areas, with restricted translational relevance to humans. Comparison between studies is thus complicated by this heterogeneous methodology and the relevance of the combined body of literature to humans remains uncertain. Future preclinical studies should use better standardized methodologies to facilitate transferability of findings from preclinical into clinical science. © 2015 John Wiley & Sons Ltd.

Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents

PubMed Central

Botkin, Jeffrey R.; Belmont, John W.; Berg, Jonathan S.; Berkman, Benjamin E.; Bombard, Yvonne; Holm, Ingrid A.; Levy, Howard P.; Ormond, Kelly E.; Saal, Howard M.; Spinner, Nancy B.; Wilfond, Benjamin S.; McInerney, Joseph D.

2015-01-01

In 1995, the American Society of Human Genetics (ASHG) and American College of Medical Genetics and Genomics (ACMG) jointly published a statement on genetic testing in children and adolescents. In the past 20 years, much has changed in the field of genetics, including the development of powerful new technologies, new data from genetic research on children and adolescents, and substantial clinical experience. This statement represents current opinion by the ASHG on the ethical, legal, and social issues concerning genetic testing in children. These recommendations are relevant to families, clinicians, and investigators. After a brief review of the 1995 statement and major changes in genetic technologies in recent years, this statement offers points to consider on a broad range of test technologies and their applications in clinical medicine and research. Recommendations are also made for record and communication issues in this domain and for professional education. PMID:26140447

Brain Dynamics: Methodological Issues and Applications in Psychiatric and Neurologic Diseases

NASA Astrophysics Data System (ADS)

Pezard, Laurent

The human brain is a complex dynamical system generating the EEG signal. Numerical methods developed to study complex physical dynamics have been used to characterize EEG since the mid-eighties. This endeavor raised several issues related to the specificity of EEG. Firstly, theoretical and methodological studies should address the major differences between the dynamics of the human brain and physical systems. Secondly, this approach of EEG signal should prove to be relevant for dealing with physiological or clinical problems. A set of studies performed in our group is presented here within the context of these two problematic aspects. After the discussion of methodological drawbacks, we review numerical simulations related to the high dimension and spatial extension of brain dynamics. Experimental studies in neurologic and psychiatric disease are then presented. We conclude that if it is now clear that brain dynamics changes in relation with clinical situations, methodological problems remain largely unsolved.

Investigating genetic discrimination in Australia: a large-scale survey of clinical genetics clients.

PubMed

Taylor, S; Treloar, S; Barlow-Stewart, K; Stranger, M; Otlowski, M

2008-07-01

We report first results from the Australian Genetic Discrimination Project of clinical genetics services clients' perceptions and experiences regarding alleged differential treatment associated with having genetic information. Adults (n = 2667) who had presented from 1998 to 2003 regarding predictive or presymptomatic testing for designated mature-onset conditions were surveyed; 951/1185 respondents met inclusion criteria for current asymptomatic status. Neurological conditions and familial cancers were primary relevant conditions for 87% of asymptomatic respondents. Specific incidents of alleged negative treatment, reported by 10% (n = 93) of respondents, occurred in life insurance (42%), employment (5%), family (22%), social (11%) and health (20%) domains. Respondents where neuro-degenerative conditions were relevant were more likely overall to report incidents and significantly more likely to report incidents in the social domain. Most incidents in the post-test period occurred in the first year after testing. Only 15% of respondents knew where to complain officially if treated negatively because of genetics issues. Recommendations include the need for increased community and clinical education regarding genetic discrimination, for extended clinical genetics sector engagement and for co-ordinated monitoring, research and policy development at national levels in order for the full benefits of genetic testing technology to be realised.

Combining interdisciplinary and International Medical Graduate perspectives to teach clinical and ethical communication using multimedia.

PubMed

Woodward-Kron, Robyn; Flynn, Eleanor; Delany, Clare

2011-01-01

In Australia, international medical graduates (IMGs) play a crucial role in addressing workforce shortages in healthcare. Their ability to deliver safe and effective healthcare in an unfamiliar cultural setting is intrinsically tied to effective communication. Hospital-based medical clinical educators, who play an important role in providing communication training to IMGs, would benefit from practical resources and an understanding of the relevant pedagogies to address these issues in their teaching. This paper examines the nature of an interdisciplinary collaboration to develop multimedia resources for teaching clinical and ethical communication to IMGs. We describe the processes and dynamics of the collaboration, and outline the methodologies from applied linguistics, medical education, and health ethics that we drew upon. The multimedia consist of three video clips of challenging communication scenarios as well as experienced IMGs talking about communication and ethics. The multimedia are supported by teaching guidelines that address relevant disciplinary concerns of the three areas of collaboration. In the paper's discussion we point out the pre-conditions that facilitated the interdisciplinary collaboration. We propose that such collaborative approaches between the disciplines and participants can provide new perspectives to address the multifaceted challenges of clinical teaching and practice.

DPYD and UGT1A1 genotyping to predict adverse events during first-line FOLFIRI or FOLFOXIRI plus bevacizumab in metastatic colorectal cancer.

PubMed

Cremolini, Chiara; Del Re, Marzia; Antoniotti, Carlotta; Lonardi, Sara; Bergamo, Francesca; Loupakis, Fotios; Borelli, Beatrice; Marmorino, Federica; Citi, Valentina; Cortesi, Enrico; Moretto, Roberto; Ronzoni, Monica; Tomasello, Gianluca; Zaniboni, Alberto; Racca, Patrizia; Buonadonna, Angela; Allegrini, Giacomo; Ricci, Vincenzo; Di Donato, Samantha; Zagonel, Vittorina; Boni, Luca; Falcone, Alfredo; Danesi, Romano

2018-01-30

Our study addresses the issue of the clinical reliability of three candidate DPYD and one UGT single nucleotide polymorphisms in predicting 5-fluorouracil- and irinotecan-related adverse events. To this purpose, we took advantage of a large cohort of metastatic colorectal cancer patients treated with first-line 5-fluorouracil- and irinotecan-based chemotherapy regimens (i.e., FOLFIRI or FOLFOXIRI) plus bevacizumab in the randomized clinical trial TRIBE by GONO (clinicaltrials.gov: NCT00719797), in which adverse events were carefully and prospectively collected at each treatment cycle. Here we show that patients bearing DPYD c.1905+1G/A and c.2846A/T genotypes, together with UGT1A1*28 variant carriers, have an increased risk of experiencing clinically relevant toxicities, including hematological AEs and stomatitis. No carrier of the DPYD c.1679T>G minor allele was identified. Present results support the preemptive screening of mentioned DPYD and UGT1A1 variants to identify patients at risk of clinically relevant 5-fluoruracil- and irinotecan-related AEs, in order to improve treatments' safety through a "genotype-guided" approach.

Enhancing the development and approval of acute stroke therapies: Stroke Therapy Academic Industry roundtable.

PubMed

Fisher, Marc; Albers, Gregory W; Donnan, Geoffrey A; Furlan, Anthony J; Grotta, James C; Kidwell, Chelsea S; Sacco, Ralph L; Wechsler, Lawrence R

2005-08-01

Previous Stroke Therapy Academic Industry Roundtable (STAIR) meetings focused on preclinical evidence of drug efficacy and enhancing acute stroke trial design and performance. A fourth (STAIR-IV) was held to discuss relevant issues related to acute stroke drug development and regulatory approval. The STAIR-IV meeting had 3 main focus areas. The first topic was novel approaches to statistical design of acute stroke trials and appropriate outcome measures. The second focus was the need for better cooperation among participants in stroke therapy development that may be addressed through a national consortium of stroke trial centers in the United States and elsewhere. Lastly, regulatory issues related to the approval of novel mono and multiple acute stroke therapies were discussed. The development of additional acute stroke therapies represents a large unmet need with many remaining challenges and also opportunities to incorporate novel approaches to clinical trial design that will lead to regulatory approval. The STAIR-IV meeting explored new concepts of trial methodology and data analysis, initiatives for implementing a US clinical trialist consortium, and pertinent regulatory issues to expedite approval of novel therapies.

Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines

PubMed Central

Norris, Susan L.; Schulman, Sam; Hirsh, Jack; Eckman, Mark H.; Akl, Elie A.; Crowther, Mark; Vandvik, Per Olav; Eikelboom, John W.; McDonagh, Marian S.; Lewis, Sandra Zelman; Gutterman, David D.; Cook, Deborah J.; Schünemann, Holger J.

2012-01-01

Background: To develop the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: ACCP Evidence-Based Clinical Practice Guidelines (AT9), the American College of Chest Physicians (ACCP) assembled a panel of clinical experts, information scientists, decision scientists, and systematic review and guideline methodologists. Methods: Clinical areas were designated as articles, and a methodologist without important intellectual or financial conflicts of interest led a panel for each article. Only panel members without significant conflicts of interest participated in making recommendations. Panelists specified the population, intervention and alternative, and outcomes for each clinical question and defined criteria for eligible studies. Panelists and an independent evidence-based practice center executed systematic searches for relevant studies and evaluated the evidence, and where resources and evidence permitted, they created standardized tables that present the quality of the evidence and key results in a transparent fashion. Results: One or more recommendations relate to each specific clinical question, and each recommendation is clearly linked to the underlying body of evidence. Judgments regarding the quality of evidence and strength of recommendations were based on approaches developed by the Grades of Recommendations, Assessment, Development, and Evaluation Working Group. Panel members constructed scenarios describing relevant health states and rated the disutility associated with these states based on an additional systematic review of evidence regarding patient values and preferences for antithrombotic therapy. These ratings guided value and preference decisions underlying the recommendations. Each topic panel identified questions in which resource allocation issues were particularly important and, for these issues, experts in economic analysis provided additional searches and guidance. Conclusions: AT9 methodology reflects the current science of evidence-based clinical practice guideline development, with reliance on high-quality systematic reviews, a standardized process for quality assessment of individual studies and the body of evidence, an explicit process for translating the evidence into recommendations, disclosure of financial as well as intellectual conflicts of interest followed by management of disclosed conflicts, and extensive peer review. PMID:22315256

How do we make models that are useful in understanding partial epilepsies?

PubMed

Prince, David A

2014-01-01

The goals of constructing epilepsy models are (1) to develop approaches to prophylaxis of epileptogenesis following cortical injury; (2) to devise selective treatments for established epilepsies based on underlying pathophysiological mechanisms; and (3) use of a disease (epilepsy) model to explore brain molecular, cellular and circuit properties. Modeling a particular epilepsy syndrome requires detailed knowledge of key clinical phenomenology and results of human experiments that can be addressed in critically designed laboratory protocols. Contributions to understanding mechanisms and treatment of neurological disorders has often come from research not focused on a specific disease-relevant issue. Much of the foundation for current research in epilepsy falls into this category. Too strict a definition of the relevance of an experimental model to progress in preventing or curing epilepsy may, in the long run, slow progress. Inadequate exploration of the experimental target and basic laboratory results in a given model can lead to a failed effort and false negative or positive results. Models should be chosen based on the specific issues to be addressed rather than on convenience of use. Multiple variables including maturational age, species and strain, lesion type, severity and location, latency from injury to experiment and genetic background will affect results. A number of key issues in clinical and basic research in partial epilepsies remain to be addressed including the mechanisms active during the latent period following injury, susceptibility factors that predispose to epileptogenesis, injury - induced adaptive versus maladaptive changes, mechanisms of pharmaco-resistance and strategies to deal with multiple pathophysiological processes occurring in parallel.

Effects of stress and mental toughness on burnout and depressive symptoms: A prospective study with young elite athletes.

PubMed

Gerber, Markus; Best, Simon; Meerstetter, Fabienne; Walter, Marco; Ludyga, Sebastian; Brand, Serge; Bianchi, Renzo; Madigan, Daniel J; Isoard-Gautheur, Sandrine; Gustafsson, Henrik

2018-05-18

To examine in a sample of young elite athletes (a) the presence of clinically relevant symptoms of burnout and depression, and (b) a possible interaction of perceived stress and mental toughness in the prediction of burnout and depressive symptoms. 6-month prospective study. A representative sample of 257 young elite athletes (M=16.82years, SD=1.44, 36% females) was recruited in North-Western Switzerland. 197 athletes were followed-up across a 6-month period. Burnout was assessed with the Shirom-Melamed Burnout Measure (SMBM), and depression with the 9-item depression module of the Patient Health Questionnaire (PHQ). Values of ≥4.40 (SMBM) and >14 (PHQ-9) were considered indicative of clinically relevant burnout or depression. Stress perceptions were assessed with the Perceived Stress Scale (PSS), and mental toughness with the Mental Toughness Questionnaire (MTQ). Hierarchical regression analyses were used to test stress-buffering effects. The percentage of athletes with clinically relevant levels of burnout and depressive symptoms was 12% and 9%, respectively. Both cross-sectional and prospective analyses showed that compared to participants with low mental toughness, those with higher mental toughness scores reported significantly fewer mental health issues, when exposed to high stress. By contrast, when stress levels were low, mental toughness was unrelated to psychological health complaints. About every tenth young elite athlete reported burnout or depressive symptoms of potential clinical relevance. While high perceived stress was associated with increased psychological health complaints, mental toughness was able to off-set some of the negative consequences resulting from high stress exposure. Copyright © 2018 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

[Clinical trials in nursing journals].

PubMed

Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

2014-01-01

Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

Quality-of-Life Priorities in Patients with Thyroid Cancer: A Multinational European Organisation for Research and Treatment of Cancer Phase I Study.

PubMed

Singer, Susanne; Husson, Olga; Tomaszewska, Iwona M; Locati, Laura D; Kiyota, Naomi; Scheidemann-Wesp, Ulrike; Hofmeister, Dirk; Winterbotham, Melanie; Brannan, Christine; Araújo, Cláudia; Gamper, Eva M; Kulis, Dagmara; Rimmele, Harald; Andry, Guy; Licitra, Lisa

2016-11-01

The objectives of this study were to determine quality of life (QoL) issues that are relevant to thyroid cancer patients cross-culturally, and to identify those with highest relevance to them in addition to the more general issues covered by the core European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). A systematic literature search provided a list of potentially relevant QoL issues to supplement the core questionnaire EORTC QLQ-C30, which is widely used in research and in care and addresses QoL issues relevant to all groups of cancer patients. A panel of experts revised this list, and thyroid cancer patients rated the issues regarding their relevance for QoL by selecting the 25 issues that they would include in a thyroid cancer-specific QoL module. The literature search and expert discussion provided a list of 71 QoL issues that was rated by thyroid cancer patients (n = 110) from seven countries. All issues were of high priority to at least some of the patients. The most frequently selected issues were sudden attacks of tiredness, exhaustion, quality of sleep, employment, social support, fear of cancer progression, fear of second operation, difficulties swallowing, and globus sensation. Thyroid cancer patients cross-culturally rate fatigue-related issues as highly important for their QoL, calling for increased efforts to find successful treatments for this problem. Vocational rehabilitation is also highly relevant for them and should therefore be an important aim of multidisciplinary care. The third important area of concern is psychological issues, especially fear of progression and of additional treatments.

A Clinical Decision Support System for Breast Cancer Patients

NASA Astrophysics Data System (ADS)

Fernandes, Ana S.; Alves, Pedro; Jarman, Ian H.; Etchells, Terence A.; Fonseca, José M.; Lisboa, Paulo J. G.

This paper proposes a Web clinical decision support system for clinical oncologists and for breast cancer patients making prognostic assessments, using the particular characteristics of the individual patient. This system comprises three different prognostic modelling methodologies: the clinically widely used Nottingham prognostic index (NPI); the Cox regression modelling and a partial logistic artificial neural network with automatic relevance determination (PLANN-ARD). All three models yield a different prognostic index that can be analysed together in order to obtain a more accurate prognostic assessment of the patient. Missing data is incorporated in the mentioned models, a common issue in medical data that was overcome using multiple imputation techniques. Risk group assignments are also provided through a methodology based on regression trees, where Boolean rules can be obtained expressed with patient characteristics.

Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust.

PubMed

Bamford, K B; Wood, S; Shaw, R J

2005-02-01

Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. The relevant regulations covering gene therapy using genetically modified vectors are reviewed and illustrated with the approach taken by a large teaching hospital NHS Trust. Key elements were Trust-wide communication and involvement of staff in a pro-active approach to risk management, with specific emphasis on staff training and engagement, waste management, audit and record keeping. This process has led to the development of proposed standards for clinical trials involving genetically modified micro-organisms.

Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation

PubMed Central

Dato, Ilaria; Burzotta, Francesco; Trani, Carlo; Crea, Filippo; Ussia, Gian Paolo

2014-01-01

Transcatheter aortic valve implantation (TAVI) using stent-based bioprostheses has recently emerged as a promising alternative to surgical valve replacement in selected patients. The main route for TAVI is retrograde access from the femoral artery using large sheaths (16-24 F). Vascular access complications are a clinically relevant issue in TAVI procedures since they are reported to occur in up to one fourth of patients and are strongly associated with adverse outcomes. In the present paper, we review the different types of vascular access site complications associated with transfemoral TAVI. Moreover, we discuss the possible optimal management strategies with particular attention to the relevance of early diagnosis and prompt treatment using endovascular techniques. PMID:25228962

Statistical issues in the design, conduct and analysis of two large safety studies.

PubMed

Gaffney, Michael

2016-10-01

The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

Ethical Issues of Social Media Usage in Healthcare.

PubMed

Denecke, K; Bamidis, P; Bond, C; Gabarron, E; Househ, M; Lau, A Y S; Mayer, M A; Merolli, M; Hansen, M

2015-08-13

Social media, web and mobile technologies are increasingly used in healthcare and directly support patientcentered care. Patients benefit from disease self-management tools, contact to others, and closer monitoring. Researchers study drug efficiency, or recruit patients for clinical studies via these technologies. However, low communication barriers in socialmedia, limited privacy and security issues lead to problems from an ethical perspective. This paper summarizes the ethical issues to be considered when social media is exploited in healthcare contexts. Starting from our experiences in social-media research, we collected ethical issues for selected social-media use cases in the context of patient-centered care. Results were enriched by collecting and analyzing relevant literature and were discussed and interpreted by members of the IMIA Social Media Working Group. Most relevant issues in social-media applications are confidence and privacy that need to be carefully preserved. The patient-physician relationship can suffer from the new information gain on both sides since private information of both healthcare provider and consumer may be accessible through the Internet. Physicians need to ensure they keep the borders between private and professional intact. Beyond, preserving patient anonymity when citing Internet content is crucial for research studies. Exploiting medical social-media in healthcare applications requires a careful reflection of roles and responsibilities. Availability of data and information can be useful in many settings, but the abuse of data needs to be prevented. Preserving privacy and confidentiality of online users is a main issue, as well as providing means for patients or Internet users to express concerns on data usage.

Ethical Issues of Social Media Usage in Healthcare

PubMed Central

Bamidis, P.; Bond, C.; Gabarron, E.; Househ, M.; Lau, A. Y. S.; Mayer, M. A.; Merolli, M.; Hansen, M.

2015-01-01

Summary Objective Social media, web and mobile technologies are increasingly used in healthcare and directly support patient-centered care. Patients benefit from disease self-management tools, contact to others, and closer monitoring. Researchers study drug efficiency, or recruit patients for clinical studies via these technologies. However, low communication barriers in social-media, limited privacy and security issues lead to problems from an ethical perspective. This paper summarizes the ethical issues to be considered when social media is exploited in healthcare contexts. Methods Starting from our experiences in social-media research, we collected ethical issues for selected social-media use cases in the context of patient-centered care. Results were enriched by collecting and analyzing relevant literature and were discussed and interpreted by members of the IMIA Social Media Working Group. Results Most relevant issues in social-media applications are confidence and privacy that need to be carefully preserved. The patient-physician relationship can suffer from the new information gain on both sides since private information of both healthcare provider and consumer may be accessible through the Internet. Physicians need to ensure they keep the borders between private and professional intact. Beyond, preserving patient anonymity when citing Internet content is crucial for research studies. Conclusion Exploiting medical social-media in healthcare applications requires a careful reflection of roles and responsibilities. Availability of data and information can be useful in many settings, but the abuse of data needs to be prevented. Preserving privacy and confidentiality of online users is a main issue, as well as providing means for patients or Internet users to express concerns on data usage. PMID:26293861

A Systemic Approach to the Development of a Sexual Abuse Protocol in a Rural Community: An Examination of Social Work Leadership Theory and Practice. Issues in Clinical Practice.

ERIC Educational Resources Information Center

Catalano, Stephen

The paper presents the multi-factorial problem of sexual abuse of children within their families, provides definitions of relevant terms (incest, sexual abuse, sexual misuse, molestation, sexual assault, rape), reviews the epidemiology of sexual abuse and its effects, and traces development of a Sexual Abuse Resource Team in a rural/resort New…

Sleep and Mental Health in Undergraduate Students with Generally Healthy Sleep Habits

PubMed Central

Milojevich, Helen M.; Lukowski, Angela F.

2016-01-01

Whereas previous research has indicated that sleep problems tend to co-occur with increased mental health issues in university students, relatively little is known about relations between sleep quality and mental health in university students with generally healthy sleep habits. Understanding relations between sleep and mental health in individuals with generally healthy sleep habits is important because (a) student sleep habits tend to worsen over time and (b) even time-limited experience of sleep problems may have significant implications for the onset of mental health problems. In the present research, 69 university students with generally healthy sleep habits completed questionnaires about sleep quality and mental health. Although participants did not report clinically concerning mental health issues as a group, global sleep quality was associated with mental health. Regression analyses revealed that nighttime sleep duration and the frequency of nighttime sleep disruptions were differentially related to total problems and clinically-relevant symptoms of psychological distress. These results indicate that understanding relations between sleep and mental health in university students with generally healthy sleep habits is important not only due to the large number of undergraduates who experience sleep problems and mental health issues over time but also due to the potential to intervene and improve mental health outcomes before they become clinically concerning. PMID:27280714

Sleep and Mental Health in Undergraduate Students with Generally Healthy Sleep Habits.

PubMed

Milojevich, Helen M; Lukowski, Angela F

2016-01-01

Whereas previous research has indicated that sleep problems tend to co-occur with increased mental health issues in university students, relatively little is known about relations between sleep quality and mental health in university students with generally healthy sleep habits. Understanding relations between sleep and mental health in individuals with generally healthy sleep habits is important because (a) student sleep habits tend to worsen over time and (b) even time-limited experience of sleep problems may have significant implications for the onset of mental health problems. In the present research, 69 university students with generally healthy sleep habits completed questionnaires about sleep quality and mental health. Although participants did not report clinically concerning mental health issues as a group, global sleep quality was associated with mental health. Regression analyses revealed that nighttime sleep duration and the frequency of nighttime sleep disruptions were differentially related to total problems and clinically-relevant symptoms of psychological distress. These results indicate that understanding relations between sleep and mental health in university students with generally healthy sleep habits is important not only due to the large number of undergraduates who experience sleep problems and mental health issues over time but also due to the potential to intervene and improve mental health outcomes before they become clinically concerning.

'Cloud computing' and clinical trials: report from an ECRIN workshop.

PubMed

Ohmann, Christian; Canham, Steve; Danielyan, Edgar; Robertshaw, Steve; Legré, Yannick; Clivio, Luca; Demotes, Jacques

2015-07-29

Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.

Emerging Trends in Clinical Research: With Implications for Population Health and Health Policy.

PubMed

Chin-Yee, Benjamin; Subramanian, S V; Verma, Amol A; Laupacis, Andreas; Razak, Fahad

2018-06-01

Policy Points: Significant advances in clinical medicine that have broader societal relevance may be less accessible to population health researchers and policymakers because of increased specialization within fields. We describe important recent clinical advances and discuss their broader societal impact. These advances include more expansive strategies for disease prevention, the rise of precision medicine, applications of human microbiome research, and new and highly successful treatments for hepatitis C infection. These recent developments in clinical research raise important issues surrounding health care costs and equitable resource allocation that necessitate an ongoing dialogue among the fields of clinical medicine, population health, and health policy. Developments in clinical medicine have important implications for population health, and there is a need for interdisciplinary engagement among clinical medicine, the social sciences, and public health research. The aim of this article is to help bridge the divide between these fields by exploring major recent advances in clinical medicine that have important implications for population health. We reviewed the most cited articles published from 2010 to 2015 in 5 high-impact clinical journals and selected 5 randomized controlled trials and 2 related clinical practice guidelines that are broadly relevant to population health and policy. We discuss the following themes: (1) expanding indications for drug therapy and the inherent medicalization of the population as highlighted by studies and clinical guidelines supporting lower blood pressure targets or widespread statin use; (2) the tension in nutritional research between quantifying the impact of isolated nutrients and studying specific foods and dietary patterns, for example, the role of the Mediterranean diet in the primary prevention of cardiovascular disease; (3) the issue of high medication costs and the challenge of providing equitable access raised by the development of new and effective treatments for hepatitis C infection; (4) emerging clinical applications of research on the human microbiome as illustrated by fecal transplant to treat Clostridium difficile infections; and (5) the promise and limitations of precision medicine as demonstrated by the rise of novel targeted therapies in oncology. These developments in clinical science hold promise for improving individual and population health and raise important questions about resource allocation, the role of prevention, and health disparities. © 2018 Milbank Memorial Fund.

Smart-Glasses: Exposing and Elucidating the Ethical Issues.

PubMed

Hofmann, Bjørn; Haustein, Dušan; Landeweerd, Laurens

2017-06-01

The objective of this study is to provide an overview over the ethical issues relevant to the assessment, implementation, and use of smart-glasses. The purpose of the overview is to facilitate deliberation, decision making, and the formation of knowledge and norms for this emerging technology. An axiological question-based method for human cognitive enhancement including an extensive literature search on smart-glasses is used to identify relevant ethical issues. The search is supplemented with relevant ethical issues identified in the literature on human cognitive enhancement (in general) and in the study of the technical aspects of smart-glasses. Identified papers were subject to traditional content analysis: 739 references were identified of which 247 were regarded as relevant for full text examinations, and 155 were included in the study. A wide variety of ethical issues with smart-glasses have been identified, such as issues related to privacy, safety, justice, change in human agency, accountability, responsibility, social interaction, power and ideology. Smart-glasses are envisioned to change individual human identity and behavior as well as social interaction. Taking these issues into account appears to be relevant when developing, deliberating, deciding on, implementing, and using smart-glasses.

Studying the Therapeutic Process by Observing Clinicians' In-Session Behaviour.

PubMed

Montaño-Fidalgo, Montserrat; Ruiz, Elena M; Calero-Elvira, Ana; Froján-Parga, María Xesús

2015-01-01

This paper presents a further step in the use and validation of a systematic, functional-analytic method of describing psychologists' verbal behaviour during therapy. We observed recordings from 92 clinical sessions of 19 adults (14 women and 5 men of Caucasian origin, with ages ranging from 19 to 51 years) treated by nine cognitive-behavioural therapists (eight women and one man, Caucasian as well, with ages ranging from 25 to 48 years). The therapists' verbal behaviour was codified and then classified according to its possible functionality. A cluster analysis of the data, followed by a discriminant analysis, showed that the therapists' verbal behaviour tended to aggregate around four types of session differentiated by their clinical objective (assessment, explanation, treatment and consolidation). These results confirm the validity of our method and enable us to further describe clinical phenomena by distinguishing psychologists' classes of clinically relevant activities. Specific learning mechanisms may be responsible for clinical change within each class. These issues should be analysed more closely when explaining therapeutic phenomena and when developing more effective forms of clinical intervention. We described therapists' verbal behaviour in a focused fashion so as to develop new research methods that evaluate psychological work moment by moment. We performed a cluster analysis in order to evaluate how the therapists' verbal behaviour was distributed throughout the intervention. A discriminant analysis gave us further information about the statistical significance and possible nature of the clusters we observed. The therapists' verbal behaviour depended on current clinical objectives and could be classified into four classes of clinically relevant activities: evaluation, explanation, treatment and consolidation. Some of the therapist's verbalizations were more important than others when carrying out these clinically relevant activities. The distribution of the therapists' verbal behaviour across classes may provide us with clues regarding the functionality of their in-session verbal behaviour. Copyright © 2014 John Wiley & Sons, Ltd.

Transforming Big Data into cancer-relevant insight: An initial, multi-tier approach to assess reproducibility and relevance

PubMed Central

2016-01-01

The Cancer Target Discovery and Development (CTD2) Network was established to accelerate the transformation of “Big Data” into novel pharmacological targets, lead compounds, and biomarkers for rapid translation into improved patient outcomes. It rapidly became clear in this collaborative network that a key central issue was to define what constitutes sufficient computational or experimental evidence to support a biologically or clinically relevant finding. This manuscript represents a first attempt to delineate the challenges of supporting and confirming discoveries arising from the systematic analysis of large-scale data resources in a collaborative work environment and to provide a framework that would begin a community discussion to resolve these challenges. The Network implemented a multi-Tier framework designed to substantiate the biological and biomedical relevance as well as the reproducibility of data and insights resulting from its collaborative activities. The same approach can be used by the broad scientific community to drive development of novel therapeutic and biomarker strategies for cancer. PMID:27401613

The role of alprazolam for the treatment of panic disorder in Australia.

PubMed

Moylan, Steven; Giorlando, Francesco; Nordfjærn, Trond; Berk, Michael

2012-03-01

To investigate the potential impact of increasing prescription rates of alprazolam for the treatment of panic disorder (PD) in Australia through a review of efficacy, tolerability and adverse outcome literature. Data were sourced by a literature search using MEDLINE, Embase, PsycINFO and a manual search of scientific journals to identify relevant articles. Clinical practice guidelines from the American Psychiatric Association, National Institute of Clinical Excellence, Royal Australian and New Zealand College of Psychiatrists and World Federation of Societies of Biological Psychiatry were sourced. Prescription data were sourced from Australian governmental sources. Alprazolam has shown efficacy for control of PD symptoms, particularly in short-term controlled clinical trials, but is no longer recommended as a first-line pharmacological treatment due to concerns about the risks of developing tolerance, dependence and abuse potential. Almost no evidence is available comparing alprazolam to current first-line pharmacological treatment. Despite this, prescription rates are increasing. A number of potential issues including use in overdose and impact on car accidents are noted. conclusion: Although effective for PD symptoms in clinical trials, a number of potential issues may exist with use. Consideration of its future place in PD treatment in Australia may be warranted.

[The Nutritional Care Experience of a Post-Operative Periampullary Cancer Patient With Cachexia].

PubMed

Liou, Yan-Ting; Chiang, Pin-Yi; Shun, Shiow-Ching

2016-04-01

Cachexia is one of the most widely overlooked of the syndromes that are experienced by cancer patients. This syndrome is especially prevalent among patients with gastroenterology tract cancer. Although the National Comprehensive Cancer Network (NCCN) issued palliative-care practice guidelines for cachexia in 2015, guidelines have yet to be issued for the clinical setting. The authors reviewed the literature and applied their clinical experience to create an approach for identifying the degree of cachexia in a post-operative patient with periampullary cancer. This approach assesses the nutritional status, physical status, laboratory results, and gastrointestinal system functions of the patient using the Cachexia Assessment Scale (CAS) and NCCN Practice Guidelines for Cachexia. The patient improved under nursing care with an increase in nutritional intake and physical activity facilitating their process of post-surgical physical recovery. The authors hope that this experience using the combined CAS-NCCN Practice Guidelines will help clinical caregivers better understand how to apply the relevant guidelines in clinical settings. The developed approach may help nurses assess the comprehensive nutrition status of patients and related factors in order to provide interventions that will decrease the progression of cachexia effectively and promote quality of life.

The Identification and Assessment of Late-life ADHD in Memory Clinics

PubMed Central

Fischer, Barbara L.; Gunter-Hunt, Gail; Steinhafel, Courtney Holm; Howell, Timothy

2013-01-01

INTRODUCTION Little data exists about attention deficit hyperactivity disorder (ADHD) in late life. While evaluating patients’ memory problems, our Memory Clinic staff has periodically identified ADHD in previously undiagnosed adults. We conducted a survey to assess the extent to which other memory clinics view ADHD as a relevant clinical issue. METHOD We developed and sent a questionnaire to Memory Clinics in the United States to ascertain how ADHD was identified and addressed. The percentage of responding memory clinics’ means of assessing and managing late-life ADHD comprised the measurements for this study. RESULTS Approximately one-half of responding memory clinics reported seeing ADHD patients. Of these, one-half reported identifying previously diagnosed cases, and almost one-half reported diagnosing ADHD themselves. One fifth of clinics reported screening regularly for ADHD, and few clinics described treatment methods. CONCLUSION Our results suggest that U.S. memory clinics may not adequately identify and address ADHD in late life. PMID:22173147

Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics.

PubMed

Li, Zhaoyang; Easton, Rachael

2018-01-01

The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field.

Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics

PubMed Central

Easton, Rachael

2018-01-01

ABSTRACT The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field. PMID:29035675

An RDF/OWL knowledge base for query answering and decision support in clinical pharmacogenetics.

PubMed

Samwald, Matthias; Freimuth, Robert; Luciano, Joanne S; Lin, Simon; Powers, Robert L; Marshall, M Scott; Adlassnig, Klaus-Peter; Dumontier, Michel; Boyce, Richard D

2013-01-01

Genetic testing for personalizing pharmacotherapy is bound to become an important part of clinical routine. To address associated issues with data management and quality, we are creating a semantic knowledge base for clinical pharmacogenetics. The knowledge base is made up of three components: an expressive ontology formalized in the Web Ontology Language (OWL 2 DL), a Resource Description Framework (RDF) model for capturing detailed results of manual annotation of pharmacogenomic information in drug product labels, and an RDF conversion of relevant biomedical datasets. Our work goes beyond the state of the art in that it makes both automated reasoning as well as query answering as simple as possible, and the reasoning capabilities go beyond the capabilities of previously described ontologies.

Managing interoperability and complexity in health systems.

PubMed

Bouamrane, M-M; Tao, C; Sarkar, I N

2015-01-01

In recent years, we have witnessed substantial progress in the use of clinical informatics systems to support clinicians during episodes of care, manage specialised domain knowledge, perform complex clinical data analysis and improve the management of health organisations' resources. However, the vision of fully integrated health information eco-systems, which provide relevant information and useful knowledge at the point-of-care, remains elusive. This journal Focus Theme reviews some of the enduring challenges of interoperability and complexity in clinical informatics systems. Furthermore, a range of approaches are proposed in order to address, harness and resolve some of the many remaining issues towards a greater integration of health information systems and extraction of useful or new knowledge from heterogeneous electronic data repositories.

A comparison of two tools to screen potentially inappropriate medication in internal medicine patients.

PubMed

Blanc, A-L; Spasojevic, S; Leszek, A; Théodoloz, M; Bonnabry, P; Fumeaux, T; Schaad, N

2018-04-01

Potentially inappropriate medication (PIM) is an important issue for inpatient management; it has been associated with safety problems, such as increases in adverse drugs events, and with longer hospital stays and higher healthcare costs. To compare two PIM-screening tools-STOPP/START and PIM-Check-applied to internal medicine patients. A second objective was to compare the use of PIMs in readmitted and non-readmitted patients. A retrospective observational study, in the general internal medicine ward of a Swiss non-university hospital. We analysed a random sample of 50 patients, hospitalized in 2013, whose readmission within 30 days of discharge had been potentially preventable, and compared them to a sample of 50 sex- and age-matched patients who were not readmitted. PIMs were screened using the STOPP/START tool, developed for geriatric patients, and the PIM-Check tool, developed for internal medicine patients. The time needed to perform each patient's analysis was measured. A clinical pharmacist counted and evaluated each PIM detected, based on its clinical relevance to the individual patient's case. The rates of screened and validated PIMs involving readmitted and non-readmitted patients were compared. Across the whole population, PIM-Check and STOPP/START detected 1348 and 537 PIMs, respectively, representing 13.5 and 5.4 PIMs/patient. Screening time was substantially shorter with PIM-Check than with STOPP/START (4 vs 10 minutes, respectively). The clinical pharmacist judged that 45% and 42% of the PIMs detected using PIM-Check and STOPP/START, respectively, were clinically relevant to individual patients' cases. No significant differences in the rates of detected and clinically relevant PIM were found between readmitted and non-readmitted patients. Internal medicine patients are frequently prescribed PIMs. PIM-Check's PIM detection rate was three times higher than STOPP/START's, and its screening time was shorter thanks to its electronic interface. Nearly half of the PIMs detected were judged to be non-clinically relevant, however, potentially overalerting the prescriber. These tools can, nevertheless, be considered useful in daily practice. Furthermore, the relevance of any PIM detected by these tools should always be carefully evaluated within the clinical context surrounding the individual patient. © 2017 John Wiley & Sons Ltd.

Cervical spondylotic myelopathy: methodological approaches to evaluate the literature and establish best evidence.

PubMed

Skelly, Andrea C; Hashimoto, Robin E; Norvell, Daniel C; Dettori, Joseph R; Fischer, Dena J; Wilson, Jefferson R; Tetreault, Lindsay A; Fehlings, Michael G

2013-10-15

Review of methods. To provide a detailed description of the methods undertaken in the articles in this focus issue pertaining to cervical spondylotic myelopathy (CSM) and ossification of the posterior longitudinal ligament (OPLL) and to describe the process used to develop summary statements and clinical recommendations regarding factors associated with the mechanisms, diagnosis, progression, and treatment of CSM and OPLL. We present methods used in conducting the systematic, evidence-based reviews and development of expert panel summary statements and clinical recommendations of the mechanisms, diagnosis, progression, and treatment of CSM and OPLL. Our intent is that clinicians will combine the information from these systematic reviews, narrative reviews, and primary research studies with an understanding of their own capacities and experience to better manage patients with CSM or OPLL and consider future research for the diagnosis and treatment of these diseases. For the systematic reviews, which make up the bulk of the studies in this focus issue, a systematic search and critical review of the English language literature was undertaken for articles published on the mechanisms, diagnosis, progression, and treatment of CSM and OPLL. Articles were screened for relevance using a priori criteria and relevant articles were critically reviewed. Whether an article was included for review depended on whether the study question was descriptive, one of therapy, or one of prognosis. The strength of evidence for the overall body of literature in each topic area was determined by 2 independent reviewers considering risk of bias, consistency, directness, and precision of results using a modification of the Grading of Recommendation Assessment, Development and Evaluation criteria. Disagreements were resolved by consensus. Findings from articles meeting inclusion criteria were summarized. From these summaries, summary statements or clinical recommendations were formulated among subject experts through a modified Delphi process using the Grading of Recommendation Assessment, Development and Evaluation approach. Methods for the 2 primary research studies and the narrative reviews are also reviewed. Because of the nature of questions that needed to be addressed, not all studies in this focus issue were amenable to systematic review. As a result, this focus issue consists of several different article types, including 1 research protocol, 2 primary research studies, 2 narrative literature reviews, 7 systematic reviews, and 3 articles that combine a systematic review component with either a narrative section (n = 2) or a provider survey (n = 1). In general, the strength of evidence ratings ranged from insufficient to moderate. Summary statements or clinical recommendations were made according to available evidence and study type: 16 summary statements were made across 8 articles, and 17 clinical recommendations were made across 9 articles. Three articles had both summary statements and clinical recommendations, 5 had summary statements only, 6 had clinical recommendations only, and 1 (the research protocol) was not amenable to either. Systematic reviews, narrative reviews, and primary research studies were undertaken to understand the mechanisms, diagnosis, progression, and treatment of CSM and OPLL and to provide summary statements and clinical recommendations. This article reports the methods used in the studies in this focus issue. SUMMARY STATEMENTS: The objectives of this focus issue were met using a variety of article and study designs, each of which has some unique methodological aspects associated with it. The reader should refer to the full article in this issue for additional details specific to that topic. The methods for systematic review follow accepted standards for rigor and, together with the application of Grading of Recommendation Assessment, Development and Evaluation, are intended to allow for transparency in the process for creating the clinical recommendation.

Computerized Neuropsychological Assessment Devices: Joint Position Paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology†

PubMed Central

Bauer, Russell M.; Iverson, Grant L.; Cernich, Alison N.; Binder, Laurence M.; Ruff, Ronald M.; Naugle, Richard I.

2012-01-01

This joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology sets forth our position on appropriate standards and conventions for computerized neuropsychological assessment devices (CNADs). In this paper, we first define CNADs and distinguish them from examiner-administered neuropsychological instruments. We then set forth position statements on eight key issues relevant to the development and use of CNADs in the healthcare setting. These statements address (a) device marketing and performance claims made by developers of CNADs; (b) issues involved in appropriate end-users for administration and interpretation of CNADs; (c) technical (hardware/software/firmware) issues; (d) privacy, data security, identity verification, and testing environment; (e) psychometric development issues, especially reliability, and validity; (f) cultural, experiential, and disability factors affecting examinee interaction with CNADs; (g) use of computerized testing and reporting services; and (h) the need for checks on response validity and effort in the CNAD environment. This paper is intended to provide guidance for test developers and users of CNADs that will promote accurate and appropriate use of computerized tests in a way that maximizes clinical utility and minimizes risks of misuse. The positions taken in this paper are put forth with an eye toward balancing the need to make validated CNADs accessible to otherwise underserved patients with the need to ensure that such tests are developed and utilized competently, appropriately, and with due concern for patient welfare and quality of care. PMID:22382386

Computerized Neuropsychological Assessment Devices: Joint Position Paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology†

PubMed Central

Bauer, Russell M.; Iverson, Grant L.; Cernich, Alison N.; Binder, Laurence M.; Ruff, Ronald M.; Naugle, Richard I.

2013-01-01

This joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology sets forth our position on appropriate standards and conventions for computerized neuropsychological assessment devices (CNADs). In this paper, we first define CNADs and distinguish them from examiner-administered neuropsychological instruments. We then set forth position statements on eight key issues relevant to the development and use of CNADs in the healthcare setting. These statements address (a) device marketing and performance claims made by developers of CNADs; (b) issues involved in appropriate end-users for administration and interpretation of CNADs; (c) technical (hardware/software/firmware) issues; (d) privacy, data security, identity verification, and testing environment; (e) psychometric development issues, especially reliability and validity; (f) cultural, experiential, and disability factors affecting examinee interaction with CNADs; (g) use of computerized testing and reporting services; and (h) the need for checks on response validity and effort in the CNAD environment. This paper is intended to provide guidance for test developers and users of CNADs that will promote accurate and appropriate use of computerized tests in a way that maximizes clinical utility and minimizes risks of misuse. The positions taken in this paper are put forth with an eye toward balancing the need to make validated CNADs accessible to otherwise underserved patients with the need to ensure that such tests are developed and utilized competently, appropriately, and with due concern for patient welfare and quality of care. PMID:22394228

How Much Health Promotion and Disease Prevention Is Enough?

PubMed Central

Terre, Lisa; Globe, Gary; Pfefer, Mark T.

2006-01-01

Introduction: Although family violence has been identified as a major public health issue, it has received little attention in the chiropractic literature. Accordingly, this article provides a conceptual overview on family violence, discusses the role of chiropractors in its detection, and raises several issues germane to chiropractic education that deserve further attention in future chiropractic publications. Methods: A selective review of the empirical literature on family violence was conducted with a focus on issues relevant to chiropractic training and professional identity. Results: Extrapolating from the research, several models for medical training and continuing education have been proposed that emphasize a multidisciplinary, developmental approach to infusing knowledge, skill building, and mentored practice experiences into professional education experiences. Conclusion: As chiropractors become more mainstream portal-of-entry providers, there is a clear need to translate the didactics of family violence into the clinical setting. Clinical education may provide students the opportunity to master basic competencies for managing challenging family violence problems. The clinical environment may be appropriate for inculcating skills commensurate with those of other primary care providers. Yet, the extent to which training priorities and approaches extrapolated from other health care disciplines should be accepted wholesale by the chiropractic profession merits further discussion, including issues around the professional identity of chiropractic, the impact of accreditation standards and practice guidelines on actual professional practice behaviors, and the possible limits and unintended consequences associated with expanding the traditional chiropractic scope of practice from a specialty to a primary care profession. PMID:18483632

Expanding Persuasion Research: Using More Personally Relevant Issues and Exploring Relevance Perceived from Message Content.

ERIC Educational Resources Information Center

Dewis, Robert; Lee, Wen-Shu

A study explored the impact on junior high school females of "don't smoke" public service announcements (PSAs) created by two groups of high school females. The study extended the research on relevance and persuasion by utilizing intimate issues, and by exploring the potential for increasing message relevance by using persuasive messages…

To Friend or Not to Friend: The Use of Social Media in Clinical Oncology

PubMed Central

Wiener, Lori; Crum, Caroline; Grady, Christine; Merchant, Melinda

2012-01-01

Online social networking has replaced more traditional methods of personal and professional communication in many segments of society today. The wide reach and immediacy of social media facilitate dissemination of knowledge in advocacy and cancer education, but the usefulness of social media in personal relationships between patients and providers is still unclear. Although professional guidelines regarding e-mail communication may be relevant to social media, the inherent openness in social networks creates potential boundary and privacy issues in the provider-patient context. This commentary seeks to increase provider awareness of unique issues and challenges raised by the integration of social networking into oncology communications. PMID:23077437

Hospital infection prevention and control issues relevant to extensive floods.

PubMed

Apisarnthanarak, Anucha; Mundy, Linda M; Khawcharoenporn, Thana; Glen Mayhall, C

2013-02-01

The devastating clinical and economic implications of floods exemplify the need for effective global infection prevention and control (IPC) strategies for natural disasters. Reopening of hospitals after excessive flooding requires a balance between meeting the medical needs of the surrounding communities and restoration of a safe hospital environment. Postflood hospital preparedness plans are a key issue for infection control epidemiologists, healthcare providers, patients, and hospital administrators. We provide recent IPC experiences related to reopening of a hospital after extensive black-water floods necessitated hospital closures in Thailand and the United States. These experiences provide a foundation for the future design, execution, and analysis of black-water flood preparedness plans by IPC stakeholders.

CULTURE, PSYCHIATRY AND NEW ZEALAND

PubMed Central

Chowdhury, A.N.; Dobson, Teara Wharemate

2002-01-01

This paper provides a critical appraisal of the importance of cultural perspective in the psychiatric diagnosis and management plan. The working philosophy of mental health services in New Zealand is primarily monocultural and based on Western medical conceptualisation of diagnosis and treatment protocol. In view of the emphasis on bicultural health perspectives in recent years and in tune with the objectives of the Treaty of Waitangi's ethnocultural partnership, the provision of a culturally safe and sensitive mental health coverage of Maori and Pacific Islander clients has become an important health issue in the country. The present discussion of the ethnocultural influence on clinical psychiatry highlights some of the relevant issues from the transcultural perspective. PMID:21206600

Biophysical Technologies for Management of Wound Bioburden

PubMed Central

Korzendorfer, Holly; Hettrick, Heather

2014-01-01

Significance: Chronic wounds commonly have high levels of bioburden and antibiotic-resistant pathogens. This review article focuses on findings from current literature related to four biophysical technologies (ultrasound, electrical stimulation, phototherapy, and negative pressure wound therapy) believed to be beneficial for managing wound bioburden and support healing. Recent Advances and Critical Issues: Recent advances for each modality are provided as a basic synopsis of the technology followed by brief overviews of the most recent literature addressing its effectiveness for managing wound bioburden, and critical issues for each modality are provided as conclusions. Future Directions: This review highlights the need for further clinically relevant studies examining bacterial levels in addition to healing progression for each technology. PMID:25493207

A systems view of health care for the poor.

PubMed Central

Prasad, N.

1989-01-01

A systems view is a synthesis of health policy, medical sociology, public health, and common clinical problems to describe the current crisis in health care for the poor. Medical sociology and public health are particularly relevant to understand the complexity of clinical issues. Although preventive medicine is in desuetude, it is crucial if we are to reduce the future liability of postponed medical care among the poor. Medicaid metamorphosed to Medicare, as half of its outlays are spent on care of the elderly in nursing homes. Health care for the poor will remain a moral challenge to the architects of health policy and the medical profession. PMID:2659807

Integration of complementary and alternative medicine information and advice in chronic disease management guidelines.

PubMed

Team, Victoria; Canaway, Rachel; Manderson, Lenore

2011-01-01

The growing evidence on the benefits and risks of complementary and alternative medicine (CAM) and its high rate of use (69% of Australians) - particularly for chronic or recurrent conditions - means increasing attention on CAM. However, few people disclose CAM use to their GP, and health professionals tend to inadequately discuss CAM-related issues with their patients, partly due to insufficient knowledge. As clinical and non-clinical chronic condition management guidelines are a means to educate primary health care practitioners, we undertook a content analysis of guidelines relevant to two common chronic conditions - cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM) - to assess their provision of CAM-related information. Ten current Australian guidelines were reviewed, revealing scant CAM content. When available, the CAM-relevant information was brief, in some cases unclear, inconclusive and lacking in direction to the GP or health care provider. Although we focus on CVD and T2DM, we argue the value of all chronic condition management guidelines integrating relevant evidence-informed information and advice on CAM risks, benefits and referrals, to increase GP awareness and knowledge of appropriate CAM therapies, and potentially to facilitate doctor-client discussion about CAM.

Content-Based Instruction.

ERIC Educational Resources Information Center

CATESOL Journal, 1992

1992-01-01

This English-as-a-Second Language (ESL) journal periodical devotes entire issues to specific issues. The theme of this issue is "Content-Base Instruction." Articles include: "Syllabus Design in Content-Based Instruction" (David E. Eskey); "How Relevant Is Relevance?: An Examination of Student Needs, Interests, and…

A misleading review of response bias: comment on McGrath, Mitchell, Kim, and Hough (2010).

PubMed

Rohling, Martin L; Larrabee, Glenn J; Greiffenstein, Manfred F; Ben-Porath, Yossef S; Lees-Haley, Paul; Green, Paul; Greve, Kevin W

2011-07-01

In the May 2010 issue of Psychological Bulletin, R. E. McGrath, M. Mitchell, B. H. Kim, and L. Hough published an article entitled "Evidence for Response Bias as a Source of Error Variance in Applied Assessment" (pp. 450-470). They argued that response bias indicators used in a variety of settings typically have insufficient data to support such use in everyday clinical practice. Furthermore, they claimed that despite 100 years of research into the use of response bias indicators, "a sufficient justification for [their] use… in applied settings remains elusive" (p. 450). We disagree with McGrath et al.'s conclusions. In fact, we assert that the relevant and voluminous literature that has addressed the issues of response bias substantiates validity of these indicators. In addition, we believe that response bias measures should be used in clinical and research settings on a regular basis. Finally, the empirical evidence for the use of response bias measures is strongest in clinical neuropsychology. We argue that McGrath et al.'s erroneous perspective on response bias measures is a result of 3 errors in their research methodology: (a) inclusion criteria for relevant studies that are too narrow; (b) errors in interpreting results of the empirical research they did include; (c) evidence of a confirmatory bias in selectively citing the literature, as evidence of moderation appears to have been overlooked. Finally, their acknowledging experts in the field who might have highlighted these errors prior to publication may have prevented critiques during the review process.

Bottlenecks in the development of topical analgesics: molecule, formulation, dose-finding, and phase III design.

PubMed

Keppel Hesselink, Jan M; Kopsky, David J; Stahl, Stephen M

2017-01-01

Topical analgesics can be defined as topical formulations containing analgesics or co-analgesics. Since 2000, interest in such formulations has been on the rise. There are, however, four critical issues in the research and development phases of topical analgesics: 1) The selection of the active pharmaceutical ingredient. Analgesics and co-analgesics differ greatly in their mechanism of action, and it is required to find the most optimal fit between such mechanisms of action and the pathogenesis of the targeted (neuropathic) pain. 2) Issues concerning the optimized formulation. For relevant clinical efficacy, specific characteristics for the selected vehicle (eg, cream base or gel base) are required, depending on the physicochemical characteristics of the active pharmaceutical ingredient(s) to be delivered. 3) Well-designed phase II dose-finding studies are required, and, unfortunately, such trials are missing. In fact, we will demonstrate that underdosing is one of the major hurdles to detect meaningful and statistically relevant clinical effects of topical analgesics. 4) Selection of clinical end points and innovatively designed phase III trials. End point selection can make or break a trial. For instance, to include numbness together with tingling as a composite end point for neuropathic pain seems stretching the therapeutic impact of an analgesic too far. Given the fast onset of action of topical analgesics (usually within 30 minutes), enrichment designs might enhance the chances for success, as the placebo response might decrease. Topical analgesics may become promising inroads for the treatment of neuropathic pain, once sufficient attention is given to these four key aspects.

Steroid-induced hyperglycaemia in hospitalised patients: does it matter?

PubMed

Cheung, N Wah

2016-12-01

Steroid-induced hyperglycaemia is a common problem faced by endocrinologists in hospital wards. In this issue of Diabetologia, Popovic and colleagues (DOI 10.1007/s00125-016-4091-4 ) have conducted a subanalysis within a randomised controlled trial of prednisone therapy for community-acquired pneumonia. The authors found that the presence of diabetes or hyperglycaemia related to steroid therapy did not attenuate the clinical benefits of steroid therapy. The relevance and possible implications of these findings are discussed.

ST-segment monitoring: putting standards into practice.

PubMed

Flanders, Sonya A

2007-01-01

ST-segment monitoring is one key reason that continuous electrocardiographic monitoring is performed in hospitals, and can help with early detection of myocardial ischemia for at-risk patients. Although ST-segment monitoring research, guidelines, and expert consensus statements have been published, ST-segment monitoring has not been implemented in all appropriate clinical areas. The purpose of this article is to present relevant research, review the latest practice standards, and discuss issues important to nurses wishing to implement ST-segment monitoring.

Estrogen receptor alpha gene amplification in breast cancer: 25 years of debate

PubMed Central

Holst, Frederik

2016-01-01

Twenty-five years ago, Nembrot and colleagues reported amplification of the estrogen receptor alpha gene (ESR1) in breast cancer, initiating a broad and still ongoing scientific debate on the prevalence and clinical significance of this genetic aberration, which affects one of the most important genes in breast cancer. Since then, a multitude of studies on this topic has been published, covering a wide range of divergent results and arguments. The reported prevalence of this alteration in breast cancer ranges from 0% to 75%, suggesting that ESR1 copy number analysis is hampered by technical and interpreter issues. To date, two major issues related to ESR1 amplification remain to be conclusively addressed: (1) The extent to which abundant amounts of messenger RNA can mimic amplification in standard fluorescence in situ hybridization assays in the analysis of strongly expressed genes like ESR1, and (2) the clinical relevance of ESR1 amplification: Such relevance is strongly disputed, with data showing predictive value for response as well as for resistance of the cancer to anti-estrogen therapies, or for subsequent development of cancers in the case of precursor lesions that display amplification of ESR1. This review provides a comprehensive summary of the various views on ESR1 amplification, and highlights explanations for the contradictions and conflicting data that could inform future ESR1 research. PMID:27081639

Baccalaureate Minority Nursing Students Perceived Barriers and Facilitators to Clinical Education Practices: An Integrative Review.

PubMed

Graham, Crystal L; Phillips, Shannon M; Newman, Susan D; Atz, Teresa W

2016-01-01

This integrative review synthesized baccalaureate minority nursing students' perceptions of their clinical experiences. The diversity of the nursing workforce does not mirror the United States population. Attrition rates of minority nursing students remain higher than rates for White students. Literature examining facilitators and barriers to minority student success predominantly focuses on academic factors, excluding those relevant to clinical education. An integrative review using literature from nursing and education. Three common perceived barriers were identified: discrimination from faculty, peers, nursing staff, and patients; bias in faculty grading practices; and isolation. Although little is known about the relationship between clinical failures and overall attrition, this review provides evidence that minority students encounter significant barriers in clinical education. To increase the diversity of the nursing workforce, faculty must address these issues and make modifications to ensure an equal opportunity at a quality education for all students.

Creating innovative clinical nurse leader practicum experiences through academic and practice partnerships.

PubMed

Jukkala, Angela; Greenwood, Rebecca; Motes, Terry; Block, Velinda

2013-01-01

The new Clinical Nurse Leader (CNL) nursing role was developed to meet the complex health care needs of patients, families, and health care systems. This article describes the process used by nurse leaders at the University of Alabama at Birmingham School of Nursing and Hospital to develop Model C CNL practicum courses, recruit and prepare clinical preceptors, prepare clinical microsystems for CNL students, and develop additional practice partnerships throughout the region. MANAGEMENT AND OUTCOME: Critical to the success of the CNL role is a dynamic partnership between academic and practice leaders.The partnership allows faculty to develop curricula that are relevant and responsive to the rapidly changing health care system. Clinical leaders become more aware of trends and issues in nursing education. Continued growth and success of the CNL role is largely dependent on the ability of faculty and practice partners to collaborate on innovative educational programs and models of care delivery.

Outcome assessment for spasticity management in the patient with traumatic brain injury: the state of the art.

PubMed

Elovic, Elie P; Simone, Lisa K; Zafonte, Ross

2004-01-01

The objective of this article was to (1) review the engineering and medical literature to structure the available information concerning the assessment of spasticity in the neurological population; (2) to discuss the strengths and weaknesses of the different methods currently in use in spasticity assessment; and (3) make recommendations for future efforts in spasticity outcome assessment. Spasticity textbooks, Web sites, and OVID, IEEE, and Medline searches from 1966 through 2003 of spasticity, quantitative measure, or outcome assessment in the rehabilitation population were used as data sources. Over 500 articles were reviewed. Articles that discussed outcome measures used to assess interventions and evaluation of spasticity were included. Authors reviewed the articles looking at inclusion criteria, data collection, methodology, assessment methods, and conclusions for validity and relevance to this article. Issues such as clinical relevance, real-world function and lack of objectivity, and time consumed during performance are important issues for spasticity assessment. Some measures such as the Ashworth Scale remain in common use secondary to ease of use despite their obvious functional limitations. More functional outcome goals are plagued by being more time consuming and a general inability to demonstrate changes after an intervention. This may be secondary to the other factors that combine with spasticity to cause dysfunction at that level. Quantitative metrics can provide more objective measurements but their clinical relevance is sometimes problematic. The assessment of spasticity outcome is still somewhat problematic. Further work is necessary to develop measures that have real-world functional significance to both the individuals being treated and the clinicians. A lack of objectivity is still a problem. In the future it is important for clinicians and the engineers to work together in the development of better outcome measures.

An integrated operational definition and conceptual model of asthma self-management in teens.

PubMed

Mammen, Jennifer; Rhee, Hyekyun; Norton, Sally A; Butz, Arlene M; Halterman, Jill S; Arcoleo, Kimberly

2018-01-19

A previous definition of adolescent asthma self-management was derived from interviews with clinicians/researchers and published literature; however, it did not incorporate perspectives of teens or parents. Therefore, we conducted in-depth interviews with teens and parents and synthesized present findings with the prior analysis to develop a more encompassing definition and model. Focal concepts were qualitatively extracted from 14-day self-management voice-diaries (n = 14) and 1-hour interviews (n = 42) with teens and parents (28 individuals) along with concepts found in the previous clinical/research oriented analysis. Conceptual structure and relationships were identified and key findings synthesized to develop a revised definition and model of adolescent asthma self-management. There were two primary self-management constructs: processes of self-management and tasks of self-management. Self-management was defined as the iterative process of assessing, deciding, and responding to specific situations in order to achieve personally important outcomes. Clinically relevant asthma self-management tasks included monitoring asthma, managing active issues through pharmacologic and non-pharmacologic strategies, preventing future issues, and communicating with others as needed. Self-management processes were reciprocally influenced by intrapersonal factors (both cognitive and physical), interpersonal factors (family, social and physical environments), and personally relevant asthma and non-asthma outcomes. This is the first definition of asthma self-management incorporating teen, parent, clinician, and researcher perspectives, which suggests that self-management processes and behaviors are influenced by individually variable personal and interpersonal factors, and are driven by personally important outcomes. Clinicians and researchers should investigate teens' symptom perceptions, medication beliefs, current approaches to symptom management, relevant outcomes, and personal priorities.

Assessment of the awareness and management of cardiovascular complications of acromegaly in Italy. The COM.E.T.A. (COMorbidities Evaluation and Treatment in Acromegaly) Study.

PubMed

Giustina, A; Mancini, T; Boscani, P F; de Menis, E; degli Uberti, E; Ghigo, E; Martino, E; Minuto, F; Colao, A

2008-08-01

During the course of acromegaly, cardiovascular, respiratory, and metabolic co-morbidities contribute to enhanced mortality. In 2002, the Pituitary Society and the European Neuroendocrine Association sponsored a Consensus Workshop in Versailles during which guidelines for diagnosis and treatment of co-morbidities in acromegaly were defined. However, as for other guidelines previously issued in the field, no data are available on their clinical application. The aim of this work coordinated by the Italian Study group on co-morbidities evaluation and treatment in acromegaly (COM.E.T.A.) was to assess, on a national basis, the application in the clinical practice of the Versailles criteria for diagnosis and treatment of cardiovascular comorbities in acromegaly. In January 2007 an ad hoc designed questionnaire was sent by mail to 130 endocrine Centers in Italy. The guidelines have been generally well perceived and translated in clinical practice. Specifically: 1) echocardiography is considered the mainstay for the diagnosis and follow-up; 2) ambulatory blood pressure monitoring and blood lipid assessment are performed in most hypertensive patients; 3) most endocrinologists directly manage hypertension and are aware of the uncertainty of the effect of the control of the disease on blood pressure levels; 4) ACE inhibitors and angiotensin receptors blockers are first-choice anti-hypertensive treatment; 5) approximately half of the centers consider somatostatin analogues of paramount relevance for biochemical control of disease; 6) awareness that left ventricular hypertrophy and heart failure are the most relevant cardiovascular complications is high although the impact of ischemic, arrhythmic, and valvular complications on prognosis is less well perceived. The results of the present survey suggest that previuosly issued guidelines are generally carefully followed in the clinical practice. On the other side, a certain lack of awareness of emerging aspects of the cardiovascular comorbities of acromegaly confirms the necessity of periodically updating the guidelines based on the availability of new clinical information.

Developing awareness of sustainability in nursing and midwifery using a scenario-based approach: Evidence from a pre and post educational intervention study.

PubMed

Richardson, Janet; Grose, Jane; Bradbury, Martyn; Kelsey, Janet

2017-07-01

The delivery of healthcare has an impact on the environment and contributes to climate change. As a consequence, the way in which nurses and midwives use and dispose of natural resources in clinical practice, and the subsequent impact on the environment, should be integral component of nursing and midwifery education. Opportunities need to be found to embed such issues into nursing curricula; thus bringing sustainability issues 'closer to home' and making them more relevant for clinical practice. The study was designed to measure the impact of a sustainability-focussed, scenario-based learning educational intervention on the attitudes and knowledge of student nurses and midwives. Pre test/Post test intervention study using scenario-based learning as the educational intervention. The Sustainability Attitudes in Nursing Survey (SANS_2) was used as the outcome measure. Clinical skills session in a UK University School of Nursing and Midwifery. 676 second year undergraduate nursing and midwifery students. The 7-point scale SANS survey was completed before and after the teaching session; standard non-parametric analysis compared pre and post intervention scores. Changes were observed in attitude towards climate change and sustainability and to the inclusion of these topics within the nursing curricula (p=0.000). Participants demonstrated greater knowledge of natural resource use and the cost of waste disposal following the session (p=0.000). Participants also reported that sessions were realistic, and levels of agreement with statements supporting the value of the session and the interactive nature of delivery were higher following the session. Using a scenario-based learning approach with nursing and midwifery students can change attitudes and knowledge towards sustainability and climate change. Embedding this approach in the context of clinical skills provides a novel and engaging approach that is both educationally sound and clinically relevant. Copyright © 2017. Published by Elsevier Ltd.

Executive functioning and visual working memory.

PubMed

Lepach, Anja C; Pauls, Franz; Petermann, Franz

2015-01-01

The matter of modality is controversially discussed in the context of working memory (WM). There is evidence that modality-specific processes are accompanied by amodal processes to some extent. We investigated the relationship between executive-functioning tasks and visual WM (VWM) and were especially interested in the issue of amodal processes. Our correlational analyses suggest modality-independent relations of the tasks. We also aimed to quantify to what extent executive functioning is meaningful for VWM performances. We therefore estimated the relationship between executive tasks and VWM performances in a healthy (n = 710) and a clinical traumatic brain injury sample (n = 151) as well as in the combined total sample. The results indicate a substantial relevance of the verbal task for VWM performances in the total and the clinical sample but a low relevance in the healthy sample. These results could support assumptions of resource-depending differences in the relations of executive functioning and VWM but need further validation due to limitations of our study.

Parenting stress and child behavior problems among clinic-referred youth: cross-cultural differences across the US and Korea.

PubMed

Chung, Kyong-Mee; Ebesutani, Chad; Bang, Hye Min; Kim, Joohee; Chorpita, Bruce F; Weisz, John R; Suh, Dongsoo; Byun, Heejung

2013-06-01

Due to increased multiculturalism in the US and abroad, there is a need for increased understanding of the different ways in which parenting stress is related to child problems across cultures. In the present study, we investigated (a) differences in reported parenting stress and childhood problem behaviors across a Korean (n = 71) and US (n = 71) sample, as well as (b) differences in the ways in which parenting stress and childhood problems were related across Korean and US children based on mothers' reports. Results revealed that Korean mothers reported significantly higher parenting stress yet significantly lower childhood problem behaviors compared to US mothers. In addition, mother-based reports of child problems were significantly associated with parenting stress in the US sample, but not in the Korean sample. Clinical implications and culturally-relevant issues relevant to these findings are addressed, including a potential under-reporting bias of child problems among Asian parents.

Evidence-based health care management: what is the research evidence available for health care managers?

PubMed

Jaana, Mirou; Vartak, Smruti; Ward, Marcia M

2014-09-01

In light of increasing interest in evidence-based management, we conducted a scoping review of systematic reviews (SRs) and meta-analyses (MAs) to determine the availability and accessibility of evidence for health care managers; 14 MAs and 61 SRs met the inclusion criteria. Most reviews appeared in medical journals (53%), originated in the United States (29%) or United Kingdom (22%), were hospital-based (55%), and targeted clinical providers (55%). Topics included health services organization (34%), quality/patient safety (17%), information technology (15%), organization/workplace management (13%), and health care workforce (12%). Most reviews addressed clinical topics of relevance to managers; management-related interventions were rare. The management issues were mostly classified as operational (65%). Surprisingly, 96.5% of search results were not on target. A better classification within PubMed is needed to increase the accessibility of meaningful resources and facilitate evidence retrieval. Health care journals should take initiatives encouraging the publication of reviews in relevant management areas. © The Author(s) 2013.

Candida bloodstream infection: a clinical microbiology laboratory perspective.

PubMed

Pongrácz, Júlia; Kristóf, Katalin

2014-09-01

The incidence of Candida bloodstream infection (BSI) has been on the rise in several countries worldwide. Species distribution is changing; an increase in the percentage of non-albicans species, mainly fluconazole non-susceptible C. glabrata was reported. Existing microbiology diagnostic methods lack sensitivity, and new methods need to be developed or further evaluation for routine application is necessary. Although reliable, standardized methods for antifungal susceptibility testing are available, the determination of clinical breakpoints remains challenging. Correct species identification is important and provides information on the intrinsic susceptibility profile of the isolate. Currently, acquired resistance in clinical Candida isolates is rare, but reports indicate that it could be an issue in the future. The role of the clinical microbiology laboratory is to isolate and correctly identify the infective agent and provide relevant and reliable susceptibility data as soon as possible to guide antifungal therapy.

European consensus conference on faecal microbiota transplantation in clinical practice

PubMed Central

Cammarota, Giovanni; Ianiro, Gianluca; Tilg, Herbert; Rajilić-Stojanović, Mirjana; Kump, Patrizia; Satokari, Reetta; Sokol, Harry; Arkkila, Perttu; Pintus, Cristina; Hart, Ailsa; Segal, Jonathan; Aloi, Marina; Masucci, Luca; Molinaro, Antonio; Scaldaferri, Franco; Gasbarrini, Giovanni; Lopez-Sanroman, Antonio; Link, Alexander; de Groot, Pieter; de Vos, Willem M; Högenauer, Christoph; Malfertheiner, Peter; Mattila, Eero; Milosavljević, Tomica; Nieuwdorp, Max; Sanguinetti, Maurizio; Simren, Magnus; Gasbarrini, Antonio

2017-01-01

Faecal microbiota transplantation (FMT) is an important therapeutic option for Clostridium difficile infection. Promising findings suggest that FMT may play a role also in the management of other disorders associated with the alteration of gut microbiota. Although the health community is assessing FMT with renewed interest and patients are becoming more aware, there are technical and logistical issues in establishing such a non-standardised treatment into the clinical practice with safety and proper governance. In view of this, an evidence-based recommendation is needed to drive the practical implementation of FMT. In this European Consensus Conference, 28 experts from 10 countries collaborated, in separate working groups and through an evidence-based process, to provide statements on the following key issues: FMT indications; donor selection; preparation of faecal material; clinical management and faecal delivery and basic requirements for implementing an FMT centre. Statements developed by each working group were evaluated and voted by all members, first through an electronic Delphi process, and then in a plenary consensus conference. The recommendations were released according to best available evidence, in order to act as guidance for physicians who plan to implement FMT, aiming at supporting the broad availability of the procedure, discussing other issues relevant to FMT and promoting future clinical research in the area of gut microbiota manipulation. This consensus report strongly recommends the implementation of FMT centres for the treatment of C. difficile infection as well as traces the guidelines of technicality, regulatory, administrative and laboratory requirements. PMID:28087657

Faculty development: a 'field of dreams'?

PubMed

Steinert, Yvonne; McLeod, Peter J; Boillat, Miriam; Meterissian, Sarkis; Elizov, Michelle; Macdonald, Mary Ellen

2009-01-01

Participants in faculty development workshops often comment that 'those who need faculty development the most attend the least'. The goals of this study were to explore the reasons why some clinical teachers do not participate in centralised faculty development activities and to learn how we can make faculty development programmes more relevant to teachers' needs. In 2006, we conducted focus groups with 16 clinical teachers, who had not participated in faculty development activities, to ascertain their perceptions of faculty development, reasons for non-participation and perceived barriers to involvement. Content analysis and team consensus guided the data interpretation. Focus group participants were aware of faculty development offerings and valued the goals of these activities. Important reasons for non-participation emerged: clinical reality, which included volume of work and lack of (protected) time; logistical issues, such as timing and the central location of organised activities; a perceived lack of financial reward and recognition for teaching, and a perceived lack of direction from, and connection to, the university. Clinical reality and logistical issues appeared to be greater deterrents to participation than faculty development goals, content or strategies. Moreover, when asked to discuss faculty development, teachers referred to their development as faculty members in the broadest sense, which included personal and career development. They also expressed the desire for clear guidance from the university, financial rewards and recognition for teaching, and a sense of 'belonging'. Faculty development programmes should try to address these organisational issues as well as teachers' personal and professional needs.

Development and use of active clinical decision support for preemptive pharmacogenomics

PubMed Central

Bell, Gillian C; Crews, Kristine R; Wilkinson, Mark R; Haidar, Cyrine E; Hicks, J Kevin; Baker, Donald K; Kornegay, Nancy M; Yang, Wenjian; Cross, Shane J; Howard, Scott C; Freimuth, Robert R; Evans, William E; Broeckel, Ulrich; Relling, Mary V; Hoffman, James M

2014-01-01

Background Active clinical decision support (CDS) delivered through an electronic health record (EHR) facilitates gene-based drug prescribing and other applications of genomics to patient care. Objective We describe the development, implementation, and evaluation of active CDS for multiple pharmacogenetic test results reported preemptively. Materials and methods Clinical pharmacogenetic test results accompanied by clinical interpretations are placed into the patient's EHR, typically before a relevant drug is prescribed. Problem list entries created for high-risk phenotypes provide an unambiguous trigger for delivery of post-test alerts to clinicians when high-risk drugs are prescribed. In addition, pre-test alerts are issued if a very-high risk medication is prescribed (eg, a thiopurine), prior to the appropriate pharmacogenetic test result being entered into the EHR. Our CDS can be readily modified to incorporate new genes or high-risk drugs as they emerge. Results Through November 2012, 35 customized pharmacogenetic rules have been implemented, including rules for TPMT with azathioprine, thioguanine, and mercaptopurine, and for CYP2D6 with codeine, tramadol, amitriptyline, fluoxetine, and paroxetine. Between May 2011 and November 2012, the pre-test alerts were electronically issued 1106 times (76 for thiopurines and 1030 for drugs metabolized by CYP2D6), and the post-test alerts were issued 1552 times (1521 for TPMT and 31 for CYP2D6). Analysis of alert outcomes revealed that the interruptive CDS appropriately guided prescribing in 95% of patients for whom they were issued. Conclusions Our experience illustrates the feasibility of developing computational systems that provide clinicians with actionable alerts for gene-based drug prescribing at the point of care. PMID:23978487

Ethical, social, and cultural issues related to clinical genetic testing and counseling in low- and middle-income countries: protocol for a systematic review.

PubMed

Zhong, Adrina; Darren, Benedict; Dimaras, Helen

2017-07-11

There has been little focus in the literature on how to build genetic testing and counseling services in low- and middle-income countries in a responsible, ethical, and culturally appropriate manner. It is unclear to what extent this area is being explored and what form further research should take. The proposed knowledge synthesis aims to fill this gap in knowledge and mine the existing data to determine the breadth of work in this area and identify ethical, social, and cultural issues that have emerged. An integrated knowledge translation approach will be undertaken by engaging knowledge users throughout the review to ensure relevance to their practice. Electronic databases encompassing various disciplines, such as healthcare, social sciences, and public health, will be searched. Studies that address clinical genetic testing and/or counseling and ethical, social, and/or cultural issues of these genetic services, and are performed in low- and middle-income countries as defined by World Bank will be considered for inclusion. Two independent reviewers will be involved in a two-stage literature screening process, data extraction, and quality appraisal. Studies included in the review will be analyzed by thematic analysis. A narrative synthesis guided by the social ecological model will be used to summarize findings. This systematic review will provide a foundation of evidence regarding ethical, social, and cultural issues related to clinical genetic testing and counseling in low- and middle-income countries. Using the social ecological model as a conceptual framework will facilitate the understanding of broader influences of the sociocultural context on an individual's experience with clinical genetic testing and counseling, thereby informing interdisciplinary sectors in future recommendations for practice and policy. PROSPERO CRD42016042894.

Posttraumatic stress disorder in a World War II concentration camp survivor caused by the attack of two German shepherd dogs: case report and review of the literature.

PubMed

Jovanović, Aleksandar A; Ivković, Maja; Gašić, Miroslava Jašović

2011-05-20

A 79-year-old woman suffered from acute posttraumatic stress disorder (PTSD) and a loco typico, non-displaced fracture of her right distal radius due to an incident involving the assault of two unleashed owned dogs, which suddenly ran into her and aggressively jumped on her chest and knocked her down to the ground. Recovery for her damage claim concerning pain and disability due to her right forearm fracture caused by the incident, was not the issue in the litigation concerned. However, the issue of delayed impact of her previous Holocaust experience placed a significant challenge on M.N., as a plaintiff, in establishing a causal link between the posttraumatic stress disorder concerned and the alleged harmful action of the defendants, the owners of the two dogs. The case reported here proved interesting and instructive not only in the sense of addressing main issues relevant to litigation for psychological damage related to reactivated PTSD and delayed PTSD, but also in the sense of pointing at the clinical relevance of dog assaults on humans which, even without dog bite injuries, may result in a severe traumatization and eventual civil lawsuit. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The role of disease characteristics in the ethical debate on personal genome testing

PubMed Central

2012-01-01

Background Companies are currently marketing personal genome tests directly-to-consumer that provide genetic susceptibility testing for a range of multifactorial diseases simultaneously. As these tests comprise multiple risk analyses for multiple diseases, they may be difficult to evaluate. Insight into morally relevant differences between diseases will assist researchers, healthcare professionals, policy-makers and other stakeholders in the ethical evaluation of personal genome tests. Discussion In this paper, we identify and discuss four disease characteristics - severity, actionability, age of onset, and the somatic/psychiatric nature of disease - and show how these lead to specific ethical issues. By way of illustration, we apply this framework to genetic susceptibility testing for three diseases: type 2 diabetes, age-related macular degeneration and clinical depression. For these three diseases, we point out the ethical issues that are relevant to the question whether it is morally justifiable to offer genetic susceptibility testing to adults or to children or minors, and on what conditions. Summary We conclude that the ethical evaluation of personal genome tests is challenging, for the ethical issues differ with the diseases tested for. An understanding of the ethical significance of disease characteristics will improve the ethical, legal and societal debate on personal genome testing. PMID:22260407

Outcomes in pediatric neurology: a review of conceptual issues and recommendationsThe 2010 Ronnie Mac Keith Lecture.

PubMed

Ronen, Gabriel M; Fayed, Nora; Rosenbaum, Peter L

2011-04-01

This paper discusses how to evaluate whether, and in what ways, treatments affect the lives of children with neurological conditions and their families. We argue that professionals should incorporate perspectives from patients and families to help them make decisions about what 'outcomes' are important, and we discuss how those outcomes might be assessed. A case vignette illustrates the differences and complementarity between the perspectives of clinicians and those of children and their parents. We recommend methods for expanding the range of relevant health outcomes in child neurology to include those that reflect the ways patients and families view their conditions and our interventions. We explore the added value of a 'non-categorical' approach to the choice of outcomes. The International Classification of Functioning, Disability and Health is a useful biopsychosocial framework to 'rule in' relevant aspects of child and family issues to create a dynamic system of possible influences on outcomes. We examine the meaning of 'health', 'health-related quality of life', and 'quality of life' as related but conceptually distinct outcomes. Specific issues are discussed about the construction, validation, and appraisal of outcome measures, as well as practical recommendations on how to select outcome measures in the clinical setting and research. © The Authors. Developmental Medicine & Child Neurology © 2011 Mac Keith Press.

From Ejtm (European Journal of Translational Myology) to Ejt3M (European Journal of Translational Myology, Mobility, Medicine)

PubMed Central

Adamo, Sergio

2018-01-01

This first 2018 Issue of the European Journal of Translational Myology presents many novelties, that are demonstrating that the journal is vital and expanding its authorship, readership and relevance from focused fields of biology, physiology, diagnostic, management and rehabilitation of skeletal muscle tissue to the more interesting and clinical relevant fields of human mobility up to those of general medicine. The Editorial Board is consequently expanded to allow fair and expert evaluation of more broadly interests and expertise of the Authors submitting typescripts. We are considering the option to move the name of the journal from Ejtm to Ejt3M (Myology, Mobility, Medicine). Criticisms and suggestions are welcomed. PMID:29686824

The changing face of clinical trials in the personalized medicine and immuno-oncology era: report from the international congress on clinical trials in Oncology & Hemato-Oncology (ICTO 2017).

PubMed

Golan, Talia; Milella, Michele; Ackerstein, Aliza; Berger, Ranaan

2017-12-28

In the past decade, the oncology community has witnessed major advances in the understanding of cancer biology and major breakthroughs in several different therapeutic areas, from solid tumors to hematological malignancies; moreover, the advent of effective immunotherapy approaches, such as immune-checkpoint blockade, is revolutionizing treatment algorithms in almost all oncology disease areas. As knowledge evolves and new weapons emerge in the "war against cancer", clinical and translational research need to adapt to a rapidly changing environment to effectively translate novel concepts into sustainable and accessible therapeutic options for cancer patients.With this in mind, translational cancer researchers, oncology professionals, treatment experts, CRO and industry leaders, as well as patient representatives gathered in London, 16-17 March 2017, for The International Congress on Clinical Trials in Oncology and Hemato-Oncology (ICTO2017), to discuss the changing face of oncology clinical trials in the new era of personalized medicine and immuno-oncology. A wide range of topics, including clinical trial design in immuno-oncology, biomarker-oriented drug development paths, statistical design and endpoint selection, challenges in the design and conduct of personalized medicine clinical trials, risk-based monitoring, financing and reimbursement, as well as best operational practices, were discussed in an open, highly interactive format, favoring networking among all relevant stakeholders. The most relevant data, approaches and issues emerged and discussed during the conference are summarized in this report.

Clinical pharmacokinetics: perceptions of hospital pharmacists in Qatar about how it was taught and how it is applied.

PubMed

Kheir, Nadir; Awaisu, Ahmed; Gad, Hoda; Elazzazy, Shereen; Jibril, Farah; Gajam, Mawadda

2015-12-01

The application of clinical pharmacokinetics (PK) is essential when providing pharmaceutical care. Appropriate application of PK monitoring results in improved patient outcomes including decreased mortality, length of treatment, length of hospital stay, and adverse effects of drug therapy. Despite the well-documented evidence of benefits of clinical PK services, many pharmacists find it challenging to apply PK in clinical practice. To evaluate pharmacists' training backgrounds, attitude, practices, and perceived barriers pertaining to the application of PK in clinical practice in Qatar. All hospitals under Hamad Medical Corporation, the main healthcare provider in Qatar. This was a cross-sectional, descriptive study that was conducted between October 2012 and January 2013, using a self-administered web-based survey. Pharmacists were eligible to participate if they: (1) were working as full-time hospital pharmacists and; (2) have been in practice for at least 1 year. PK contents learned in undergraduate curriculum; perception towards the PK contents and instructions received in the undergraduate curriculum and; application of PK in current clinical practice. A total of 112 pharmacists responded to the questionnaire. The majority of the respondents (n = 91; 81.3 %) reported that they had received PK course(s) in their undergraduate curriculum. Similarly, the majority (70-80 %) of them agreed that the undergraduate PK courses or contents they received were important and relevant to their current practice. The pharmacists identified spending more time on dispensing and inventory issues rather than clinical practice, scarce resources, and manual rather than computerized PK calculations as some of the barriers they encountered in learning about PK and its application. The characteristics of the surveyed pharmacists such as gender, age, highest academic degree, and country of graduation did not influence the pharmacists' perception and attitudes towards PK teaching and application (p > 0.05). PK course contents were perceived to lack depth and relevance to practice, and pharmacist had no experiential training that included aspects of PK. These, and other issues, result in poor application of PK in practice.

Learning experience of Chinese nursing students in an online clinical English course: qualitative study.

PubMed

Tang, Anson C Y; Wong, Nick; Wong, Thomas K S

2015-02-01

The low English proficiency of Chinese nurse/nursing students affects their performance when they work in English-speaking countries. However, limited resources are available to help them improve their workplace English, i.e. English used in a clinical setting. To this end, it is essential to look for an appropriate and effective means to assist them in improving their clinical English. The objective of this study is to evaluate the learning experience of Chinese nursing students after they have completed an online clinical English course. Focus group interview was used to explore their learning experience. 100 students in nursing programs at Tung Wah College were recruited. The inclusion criteria were: (1) currently enrolled in a nursing program; and (2) having clinical experience. Eligible participants self-registered for the online English course, and were required to complete the course within 3 months. After that, semi-structured interviews were conducted on students whom completed the whole and less than half of the course. One of the researchers joined each of the interviews as a facilitator and an observer. Thematic analysis was used to analyze the data. Finally, 7 themes emerged from the interviews: technical issues, adequacy of support, time requirement, motivation, clarity of course instruction, course design, and relevancy of the course. Participants had varied opinions on the 2 themes: motivation and relevancy of the course. Overall, results of this study suggest that the online English course helped students improve their English. Factors which support their learning are interactive course design, no time constraint, and relevancy to their work/study. Factors which detracted from their learning are poor accessibility, poor technical and learning support and no peer support throughout the course. Copyright © 2014. Published by Elsevier Ltd.

Clinical librarians as facilitators of nurses' evidence-based practice.

PubMed

Määttä, Sylvia; Wallmyr, Gudrun

2010-12-01

The aim of this study was to explore nurses' and ward-based clinical librarians' reflections on ward-based clinical librarians as facilitators for nurses' use of evidences-based practice. Nurses' use of evidence-based practice is reported to be weak. Studies have suggested that clinical librarians may promote evidence-based practice. To date, little is known about clinical librarians participating nurses in the wards. A descriptive, qualitative design was adopted for the study. In 2007, 16 nurses who had been attended by a clinical librarian in the wards were interviewed in focus groups. Two clinical librarians were interviewed by individual interviews. In the analysis, a content analysis was used. Three themes were generated from the interviews with nurses: 'The grip of everyday work', 'To articulate clinical nursing issues' and 'The clinical librarians at a catalyst'. The nurses experienced the grip of everyday work as a hindrance and had difficulties to articulate and formulate relevant nursing issues. In such a state, the nurses found the clinical librarian presence in the ward as enhancing the awareness of and the use of evidence-based practice. Three themes emerged from the analysis with the librarians. They felt as outsiders, had new knowledge and acquired a new role as ward-based clinical librarians. Facilitation is needed if nurses' evidence-based practice is going to increase. The combined use of nurses and clinical librarians' knowledge and skills can be optimised. To achieve this, nurses' skills in consuming and implementing evidence ought to be strengthened. The fusion of the information and knowledge management skill of the ward-based clinical librarian and the clinical expertise of the nurses can be of value. With such a collaborative model, nurse and ward-based clinical librarian might join forces to increase the use of evidence-based practice. © 2010 Blackwell Publishing Ltd.

Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example.

PubMed

Armijo-Olivo, Susan; Warren, Sharon; Fuentes, Jorge; Magee, David J

2011-12-01

Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. Copyright © 2011 Elsevier Ltd. All rights reserved.

How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines?

PubMed Central

Laverty, HG; Benson, C; Cartwright, EJ; Cross, MJ; Garland, C; Hammond, T; Holloway, C; McMahon, N; Milligan, J; Park, BK; Pirmohamed, M; Pollard, C; Radford, J; Roome, N; Sager, P; Singh, S; Suter, T; Suter, W; Trafford, A; Volders, PGA; Wallis, R; Weaver, R; York, M; Valentin, JP

2011-01-01

Given that cardiovascular safety liabilities remain a major cause of drug attrition during preclinical and clinical development, adverse drug reactions, and post-approval withdrawal of medicines, the Medical Research Council Centre for Drug Safety Science hosted a workshop to discuss current challenges in determining, understanding and addressing ‘Cardiovascular Toxicity of Medicines’. This article summarizes the key discussions from the workshop that aimed to address three major questions: (i) what are the key cardiovascular safety liabilities in drug discovery, drug development and clinical practice? (ii) how good are preclinical and clinical strategies for detecting cardiovascular liabilities? and (iii) do we have a mechanistic understanding of these liabilities? It was concluded that in order to understand, address and ultimately reduce cardiovascular safety liabilities of new therapeutic agents there is an urgent need to: Fully characterize the incidence, prevalence and impact of drug-induced cardiovascular issues at all stages of the drug development process. Ascertain the predictive value of existing non-clinical models and assays towards the clinical outcome. Understand the mechanistic basis of cardiovascular liabilities; by addressing areas where it is currently not possible to predict clinical outcome based on preclinical safety data. Provide scientists in all disciplines with additional skills to enable them to better integrate preclinical and clinical data and to better understand the biological and clinical significance of observed changes. Develop more appropriate, highly relevant and predictive tools and assays to identify and wherever feasible to eliminate cardiovascular safety liabilities from molecules and wherever appropriate to develop clinically relevant and reliable safety biomarkers. PMID:21306581

Cell-surface central nervous system autoantibodies: Clinical relevance and emerging paradigms

PubMed Central

Irani, Sarosh R; Gelfand, Jeffrey M; Al-Diwani, Adam; Vincent, Angela

2014-01-01

The recent discovery of several potentially pathogenic autoantibodies has helped identify patients with clinically distinctive central nervous system diseases that appear to benefit from immunotherapy. The associated autoantibodies are directed against the extracellular domains of cell-surface–expressed neuronal or glial proteins such as LGI1, N-methyl-D-aspartate receptor, and aquaporin-4. The original descriptions of the associated clinical syndromes were phenotypically well circumscribed. However, as availability of antibody testing has increased, the range of associated patient phenotypes and demographics has expanded. This in turn has led to the recognition of more immunotherapy-responsive syndromes in patients presenting with cognitive and behavioral problems, seizures, movement disorders, psychiatric features, and demyelinating disease. Although antibody detection remains diagnostically important, clinical recognition of these distinctive syndromes should ensure early and appropriate immunotherapy administration. We review the emerging paradigm of cell-surface–directed antibody–mediated neurological diseases, describe how the associated disease spectrums have broadened since the original descriptions, discuss some of the methodological issues regarding techniques for antibody detection and emphasize considerations surrounding immunotherapy administration. As these disorders continue to reach mainstream neurology and even psychiatry, more cell-surface–directed antibodies will be discovered, and their possible relevance to other more common disease presentations should become more clearly defined. PMID:24930434

Avoidant restrictive food intake disorder: an illustrative case example.

PubMed

Bryant-Waugh, Rachel

2013-07-01

Avoidant/restrictive food intake disorder (ARFID) is a new diagnostic category in DSM-5. Although replacing Feeding Disorder of Infancy or Early Childhood, it is not restricted to childhood presentations. In keeping with the broader aim of revising and updating criteria and text to better reflect lifespan issues and clinical expression across the age range, ARFID is a diagnosis relevant to children, adolescents, and adults. This case example of a 13-year old boy with ARFID illustrates key issues in diagnosis and treatment planning. The issues discussed are not exhaustive, but serve as a guide for central diagnostic and treatment issues to be considered by the clinician. It is anticipated that the inclusion of specific criteria for ARFID as a category within Feeding and Eating Disorders in DSM-5 will stimulate research into its typology, prevalence, and incidence in different populations and facilitate the development of effective, evidence-based interventions for this patient group. Copyright © 2013 Wiley Periodicals, Inc.

Ethical issues in pediatric genetic testing and screening.

PubMed

Botkin, Jeffrey R

2016-12-01

Developments in genetic test technologies enable a detailed analysis of the genomes of individuals across the range of human development from embryos to adults with increased precision and lower cost. These powerful technologies raise a number of ethical issues in pediatrics, primarily because of the frequent lack of clinical utility of genetic information, the generation of secondary results and questions over the proper scope of parental authority for testing. Several professional organizations in the fields of genetics and pediatrics have published new guidance on the ethical, legal, and policy issues relevant to genetic testing in children. The roles of predictive testing for adult-onset conditions, the management of secondary findings and the role of informed consent for newborn screening remain controversial. However, research and experience are not demonstrating serious adverse psychosocial impacts from genetic testing and screening in children. The use of these technologies is expanding with the notion that the personal utility of test results, rather than clinical utility, may be sufficient to justify testing. The use of microarray and genome sequencing technologies is expanding in the care of children. More deference to parental decision-making is evolving in contexts wherein information and counseling can be made readily available.

Depo-Provera--ethical issues in its testing and distribution.

PubMed Central

Potts, M; Paxman, J M

1984-01-01

Ethical issues relating to the use of the injectable contraceptive in developed and developing countries alike involve public policy decisions concerning both criteria for testing a new drug and individual choices about using a specific form of contraception approved for national distribution. Drug testing consists of an important but still evolving set of procedures. Depo-Provera is not qualitatively different from any other drug and some unpredictable risks are inevitable, even after extensive animal experiments and clinical trials. In assessing the risks and benefits of Depo-Provera use, epidemiological data from large-scale human use is now beginning to become more important than data from animal experiments and clinical trials. The consumer's best interest is central to any ethically responsible system of drug distribution. Systems of informed choice are needed, even in societies where illiteracy remains common and medical services are weak. In the case of a contraceptive, the risks of non-use leading to unintended pregnancy, which can result in high mortality, are relevant as well as the side-effects of the method. An attempt, therefore, is made here to categorise those issues which are universal and those which are country-specific. PMID:6231379

Ethical Perspectives on RNA Interference Therapeutics

PubMed Central

Ebbesen, Mette; Jensen, Thomas G.; Andersen, Svend; Pedersen, Finn Skou

2008-01-01

RNA interference is a mechanism for controlling normal gene expression which has recently begun to be employed as a potential therapeutic agent for a wide range of disorders, including cancer, infectious diseases and metabolic disorders. Clinical trials with RNA interference have begun. However, challenges such as off-target effects, toxicity and safe delivery methods have to be overcome before RNA interference can be considered as a conventional drug. So, if RNA interference is to be used therapeutically, we should perform a risk-benefit analysis. It is ethically relevant to perform a risk-benefit analysis since ethical obligations about not inflicting harm and promoting good are generally accepted. But the ethical issues in RNA interference therapeutics not only include a risk-benefit analysis, but also considerations about respecting the autonomy of the patient and considerations about justice with regard to the inclusion criteria for participation in clinical trials and health care allocation. RNA interference is considered a new and promising therapeutic approach, but the ethical issues of this method have not been greatly discussed, so this article analyses these issues using the bioethical theory of principles of the American bioethicists, Tom L. Beauchamp and James F. Childress. PMID:18612370

[What's new in clinical dermatology?

PubMed

Petit, A

2017-12-01

In addition to continuous medical education, medical journals offer to dermatologists a huge variety of news that differ by their content, validity, originality and clinical relevance. I collected here various articles relative to clinical dermatology that have been published between September, 2016 and September, 2017. These papers have been chosen in the aim of reflecting such diversity. I just excluded, as far as possible, articles dealing with other issues that the reader will find further in this booklet (such as research, pediatric, instrumental, oncologic or therapeutic dermatology, or dermatology and internal medicine). Space restriction required to skip some commentaries while keeping the references to the selected papers, which the reader will be able to read carefully in its original form. © 2017 Elsevier Masson SAS. Tous droits réservés.

Why nursing has not embraced the clinician--scientist role.

PubMed

Mackay, Martha

2009-10-01

Reasons for the limited uptake of the clinician-scientist role within nursing are examined, specifically: the lack of consensus about the nature of nursing science; the varying approaches to epistemology; and the influence of post-modern thought on knowledge development in nursing. It is suggested that under-development of this role may be remedied by achieving agreement that science is a necessary, worthy pursuit for nursing, and that rigorous science conducted from a clinical perspective serves nursing well. Straddling practice and research is a powerful strategy for ensuring relevant research while forging strong links with practice. The clinician-scientist role, typically requiring a 75:25 ratio between research and clinical activities, is well established in medicine. Nursing, however, has been slow to institute the role; it is rare within North America, Australia, and western European countries, and almost non-existent outside those areas. Beyond structural obstacles, philosophical issues may explain nursing's reluctance to implement the role. Following a survey of clinician-scientist roles throughout the world, the nature of nursing science and epistemology, and the influence of post-modern thought on nursing attitudes to research are examined with respect to their influence on this role. The nurse clinician-scientist role holds promise for making strides in clinically relevant research, and for accelerating the knowledge cycle from clinical problem to research question to change in clinical practice.

Balance Theory Revisited: Relationship Issue Relevance Affects Imbalance-Induced Tension in Workplace Relationships.

PubMed

Reid, Chelsea A; Davis, Jody L; Pollack, Jeffrey M; Coughlan, Richard S

2017-08-18

The present work applies and extends balance theory by examining the role of relevance of issue to the relationship in balance theory processes within the context of workplace relationships. In Experiment 1, a sample of working adults (N = 81) reported greater job tension when self-supervisor dissimilarity involved a relationship-relevant (vs. non-relationship) ethical dilemma. In Experiment 2, a sample of working students (N = 185) who perceived greater self-supervisor dissimilarity about workplace (vs. family) ethics reported greater job tension, and in turn, less job satisfaction and organizational commitment. Perceiving dissimilarity with a work supervisor in attitudes about relationship-relevant issues may negatively affect outcomes at work. Importantly, these experiments demonstrated that not all dissimilarity is likely to yield negative outcomes; only relationship-relevant (vs. non-relevant) dissimilarity was a catalyst for imbalance-induced tension.

Phlebotomy, a bridge between laboratory and patient.

PubMed

Ialongo, Cristiano; Bernardini, Sergio

2016-01-01

The evidence-based paradigm has changed and evolved medical practice. Phlebotomy, which dates back to the age of ancient Greece, has gained experience through the evolution of medicine becoming a fundamental diagnostic tool. Nowadays it connects the patient with the clinical laboratory dimension building up a bridge. However, more often there is a gap between laboratory and phlebotomist that causes misunderstandings and burdens on patient safety. Therefore, the scope of this review is delivering a view of modern phlebotomy to "bridge" patient and laboratory. In this regard the paper describes devices, tools and procedures in the light of the most recent scientific findings, also discussing their impact on both quality of blood testing and patient safety. It also addresses the issues concerning medical aspect of venipuncture, like the practical approach to the superficial veins anatomy, as well as the management of the patient's compliance with the blood draw. Thereby, the clinical, technical and practical issues are treated with the same relevance throughout the entire paper.

Phlebotomy, a bridge between laboratory and patient

PubMed Central

Ialongo, Cristiano; Bernardini, Sergio

2016-01-01

The evidence-based paradigm has changed and evolved medical practice. Phlebotomy, which dates back to the age of ancient Greece, has gained experience through the evolution of medicine becoming a fundamental diagnostic tool. Nowadays it connects the patient with the clinical laboratory dimension building up a bridge. However, more often there is a gap between laboratory and phlebotomist that causes misunderstandings and burdens on patient safety. Therefore, the scope of this review is delivering a view of modern phlebotomy to “bridge” patient and laboratory. In this regard the paper describes devices, tools and procedures in the light of the most recent scientific findings, also discussing their impact on both quality of blood testing and patient safety. It also addresses the issues concerning medical aspect of venipuncture, like the practical approach to the superficial veins anatomy, as well as the management of the patient’s compliance with the blood draw. Thereby, the clinical, technical and practical issues are treated with the same relevance throughout the entire paper. PMID:26981016

DWI at MR Enterography for Evaluating Bowel Inflammation in Crohn Disease.

PubMed

Park, Seong Ho

2016-07-01

The purpose of this article is to provide a comprehensive review regarding DWI enterography used for evaluating Crohn disease and to summarize the relevant evidence. Active bowel inflammation in Crohn disease causes restricted diffusion on MR enterography with DWI. Enterographic DWI to evaluate Crohn disease is increasingly drawing attention for both academic research and clinical practice and has shown potential as a quantitative tool for assessing bowel inflammation. DWI enterography also has multiple unresolved issues and limitations.

Behavioral Health Program Element

NASA Technical Reports Server (NTRS)

Leveton, Lauren B.

2006-01-01

The project goal is to develop behavioral health prevention and maintenance system for continued crew health, safety, and performance for exploration missions. The basic scope includes a) Operationally-relevant research related to clinical cognitive and behavioral health of crewmembers; b) Ground-based studies using analog environments (Antarctic, NEEMO, simulations, and other testbeds; c) ISS studies (ISSMP) focusing on operational issues related to behavioral health outcomes and standards; d) Technology development activities for monitoring and diagnostic tools; and e) Cross-disciplinary research (e.g., human factors and habitability research, skeletal muscle, radiation).

Psychiatry and the 'Gay Holocaust' - the lessons of Jill Soloway's Transparent.

PubMed

Robertson, Michael D; Light, Edwina; Walter, Garry; Lipworth, Wendy

2016-12-01

We aim to consider issues relevant to psychiatry raised by the television series, Transparent. Psychiatry's disturbing history regarding the lesbian, gay, bisexual, transgender and intersex (LGBTI) community shares many aspects with the group's persecution by the National Socialist regime in Germany. The medicalised 'otherness' conferred on LGBTI patients, latent homophobia and transphobia, and lack of culturally sensitive clinical services for these people represent a major ethical challenge for modern Australasian psychiatry. © The Royal Australian and New Zealand College of Psychiatrists 2016.

Older Driver Safety: A Survey of Psychologists' Attitudes, Knowledge, and Practices.

PubMed

Love, Janet; Tuokko, Holly

2016-09-01

Using an online survey, we examined the knowledge, attitudes, and practices with respect to older driver safety concerns of clinical psychologists from across Canada who self-identified as working with at least some drivers over 60 years of age. Eighty-four psychologists completed the survey, and many were aware of the issues relevant to older driver safety, although only about half reported that assessing fitness to drive was an important issue in their practice. The majority (75%) reported that they would benefit from education concerning evaluation of fitness to drive. The primary recommendation emerging from this investigation is to increase efforts to inform and educate psychologists about driving-related assessment and regulatory issues in general, and specifically with respect to older adults. As the population ages, it is of growing importance for all health care providers to understand the influence of mental health conditions-including cognitive impairment and dementia-on driving skills.

The role of noise in clinical environments with particular reference to mental health care: A narrative review.

PubMed

Brown, Brian; Rutherford, Peter; Crawford, Paul

2015-09-01

There is a large literature suggesting that noise can be detrimental to health and numerous policy documents have promoted noise abatement in clinical settings. This paper documents the role of noise in clinical environments and its deleterious effects with a particular focus on mental health care. Our intention however, is to go beyond the notion that noise is simply undesirable and examine the extent to which researchers have explored the meaning of sound in hospital settings and identify new opportunities for research and practice. This is a narrative review which has grouped the literature and issues in the field into themes concerning the general issues of noise in health care; sleep noise and hospital environments; noise in intensive care units; implications for service users and staff; and suggestions for new ways of conceptualising and researching clinical soundscapes. Data sources comprised relevant UK policy documents and the results of a literature search of Pubmed, Scopus and Web of Knowledge using terms such as noise, health, hospital, soundscape and relevant additional terms derived from the papers retrieved. In addition the references of retrieved articles were scanned for additional relevant material and historical items significant in shaping the field. Excess unwanted noise can clearly be detrimental to health and impede recovery, and this is clearly recognised by policymakers especially in the UK context. We use the literature surveyed to argue that it is important also to see the noise in clinical environments in terms of the meaning it conveys and rather than merely containing unwanted sound, clinical environments have a 'soundscape'. This comprises noises which convey meaning, for example about the activities of other people, the rhythms of the day and the nature of the auditory community of the hospital. Unwanted sound may have unwanted effects, especially on those who are most vulnerable, yet this does not necessarily mean that silence is the better option. Therefore it is our contention that it is important to begin thinking about the social functions of sound in the mental health environment. Whilst it can be stressful, sound can also be soothing, reassuring and a rich source of information about the environment as well. It may be used to secure a degree of privacy for oneself, to exclude others or as a source of solidarity among friends and colleagues. The challenge then is to understand the work that sound does in its ecological context in health care settings. Copyright © 2015. Published by Elsevier Ltd.

Clostridium Difficile Infection Due to Pneumonia Treatment: Mortality Risk Models.

PubMed

Chmielewska, M; Zycinska, K; Lenartowicz, B; Hadzik-Błaszczyk, M; Cieplak, M; Kur, Z; Wardyn, K A

2017-01-01

One of the most common gastrointestinal infection after the antibiotic treatment of community or nosocomial pneumonia is caused by the anaerobic spore Clostridium difficile (C. difficile). The aim of this study was to retrospectively assess mortality due to C. difficile infection (CDI) in patients treated for pneumonia. We identified 94 cases of post-pneumonia CDI out of the 217 patients with CDI. The mortality issue was addressed by creating a mortality risk models using logistic regression and multivariate fractional polynomial analysis. The patients' demographics, clinical features, and laboratory results were taken into consideration. To estimate the influence of the preceding respiratory infection, a pneumonia severity scale was included in the analysis. The analysis showed two statistically significant and clinically relevant mortality models. The model with the highest prognostic strength entailed age, leukocyte count, serum creatinine and urea concentration, hematocrit, coexisting neoplasia or chronic obstructive pulmonary disease. In conclusion, we report on two prognostic models, based on clinically relevant factors, which can be of help in predicting mortality risk in C. difficile infection, secondary to the antibiotic treatment of pneumonia. These models could be useful in preventive tailoring of individual therapy.

Space for the Prisoner's Point of View.

PubMed

Haupt, Laura

2017-03-01

The lead article in this issue discusses a potentially free metaphorical space-that of decision-making-within the confines, tangible and intangible, of life in jail or prison. By interviewing prisoner-participants from six clinical studies, Paul Christopher and colleagues sought to find out how these men and women would answer open-ended questions about their decision to enroll in the research. What the interviewers heard was that none saw themselves as having been inappropriately pressured to do so. In fact, a significant percentage of the prisoners described being dissuaded from participating in the studies. The authors therefore advise that unfair exploitation poses the more relevant research risk to contemporary prisoners in the United States than does coercion, and they encourage investigations into whether prisoners are unfairly restricted or discouraged from joining clinical studies. Although Keramet Reiter makes no reference to etymology in her commentary responding to the article, her argument suggests that the roots of "coerce"-the Latin for "shut up" or "enclose"-remain relevant. Reiter argues that, under current conditions, the people shut up in prisons in the United States cannot make an unfettered choice to join a clinical trial. © 2017 The Hastings Center.

Assessment methodologies and statistical issues for computer-aided diagnosis of lung nodules in computed tomography: contemporary research topics relevant to the lung image database consortium.

PubMed

Dodd, Lori E; Wagner, Robert F; Armato, Samuel G; McNitt-Gray, Michael F; Beiden, Sergey; Chan, Heang-Ping; Gur, David; McLennan, Geoffrey; Metz, Charles E; Petrick, Nicholas; Sahiner, Berkman; Sayre, Jim

2004-04-01

Cancer of the lung and bronchus is the leading fatal malignancy in the United States. Five-year survival is low, but treatment of early stage disease considerably improves chances of survival. Advances in multidetector-row computed tomography technology provide detection of smaller lung nodules and offer a potentially effective screening tool. The large number of images per exam, however, requires considerable radiologist time for interpretation and is an impediment to clinical throughput. Thus, computer-aided diagnosis (CAD) methods are needed to assist radiologists with their decision making. To promote the development of CAD methods, the National Cancer Institute formed the Lung Image Database Consortium (LIDC). The LIDC is charged with developing the consensus and standards necessary to create an image database of multidetector-row computed tomography lung images as a resource for CAD researchers. To develop such a prospective database, its potential uses must be anticipated. The ultimate applications will influence the information that must be included along with the images, the relevant measures of algorithm performance, and the number of required images. In this article we outline assessment methodologies and statistical issues as they relate to several potential uses of the LIDC database. We review methods for performance assessment and discuss issues of defining "truth" as well as the complications that arise when truth information is not available. We also discuss issues about sizing and populating a database.

Diagnosis and management of spinal muscular atrophy: Part 2: Pulmonary and acute care; medications, supplements and immunizations; other organ systems; and ethics.

PubMed

Finkel, Richard S; Mercuri, Eugenio; Meyer, Oscar H; Simonds, Anita K; Schroth, Mary K; Graham, Robert J; Kirschner, Janbernd; Iannaccone, Susan T; Crawford, Thomas O; Woods, Simon; Muntoni, Francesco; Wirth, Brunhilde; Montes, Jacqueline; Main, Marion; Mazzone, Elena S; Vitale, Michael; Snyder, Brian; Quijano-Roy, Susana; Bertini, Enrico; Davis, Rebecca Hurst; Qian, Ying; Sejersen, Thomas

2018-03-01

This is the second half of a two-part document updating the standard of care recommendations for spinal muscular atrophy published in 2007. This part includes updated recommendations on pulmonary management and acute care issues, and topics that have emerged in the last few years such as other organ involvement in the severe forms of spinal muscular atrophy and the role of medications. Ethical issues and the choice of palliative versus supportive care are also addressed. These recommendations are becoming increasingly relevant given recent clinical trials and the prospect that commercially available therapies will likely change the survival and natural history of this disease. Copyright © 2017. Published by Elsevier B.V.

How much health promotion and disease prevention is enough?: should chiropractic colleges focus on efficacy training in screening for family violence?

PubMed

Terre, Lisa; Globe, Gary; Pfefer, Mark T

2006-01-01

Although family violence has been identified as a major public health issue, it has received little attention in the chiropractic literature. Accordingly, this article provides a conceptual overview on family violence, discusses the role of chiropractors in its detection, and raises several issues germane to chiropractic education that deserve further attention in future chiropractic publications. A selective review of the empirical literature on family violence was conducted with a focus on issues relevant to chiropractic training and professional identity. Extrapolating from the research, several models for medical training and continuing education have been proposed that emphasize a multidisciplinary, developmental approach to infusing knowledge, skill building, and mentored practice experiences into professional education experiences. As chiropractors become more mainstream portal-of-entry providers, there is a clear need to translate the didactics of family violence into the clinical setting. Clinical education may provide students the opportunity to master basic competencies for managing challenging family violence problems. The clinical environment may be appropriate for inculcating skills commensurate with those of other primary care providers. Yet, the extent to which training priorities and approaches extrapolated from other health care disciplines should be accepted wholesale by the chiropractic profession merits further discussion, including issues around the professional identity of chiropractic, the impact of accreditation standards and practice guidelines on actual professional practice behaviors, and the possible limits and unintended consequences associated with expanding the traditional chiropractic scope of practice from a specialty to a primary care profession.

PSYCHOSIS IN RELATION TO EPILEPSY - A CLINICAL MODEL OF NEURO - PSYCHIATRY

PubMed Central

Shrivastava, Amresh Kumar

1996-01-01

Psychosis occurring in epileptics has always been an area of research interest, particularly, because of possible link of mental illness, organic lesions, convulsive process and behavioural abnormlity, all occuring together in the same subject. Vast amount of investigation on this subject has been done with a view to understand something more fundamental in ‘Brain-Behaviour Connection’. Occurance of interictal phase of psychosis long after cessation of seizure has driven investigators to conclude the two being unrelated, which has brought important issues of brain pathology and behavioural abnormality into focus of research from dimensions of genetics, neuroendocrine and environmental influences. The aspects of behavioural neurology, behavioural genetics, genetics of epilepsy and ‘shared common genetic diathesis for development of psychosis, possibly converge in the neuropsychiatric model of psychosis in relation to epilepsy’. E.E.G.- spiking and regional slow waves in inter - ictal phase are emerging as correlates determining behaviour. Status of prolactin - dopamine relationship and its correlation to neuro - cognition may be another pointer in guiding some of these complex issues. It is expected that current focus of research should be able to develop on the profile of ‘psychotic brain’ also. One of the major clinical issue is identifying epileptic subjects prone to develop psychosis with precision of nature and type, not only because such developments jeopardises and compromises the state of art treatment done for epilepsy, but also because of devastating deterioration in quality of life of patients and relatives, besides having pharmacoeconmic devaluations. Studies have revealed that more detailed work up in the beginning may possibly identify high risk groups based upon clinical phenomenlogy, E.E.G. topography, endocrine status, regional brain damage, etc. The presention attempts to focus some of the relevant clinical issues with reference to a particular comparative study of psychosis in epilepsy and functional psychosis (schizophrenia) to understand co-existence of divergent clinical conditions. PMID:21584119

Human Trafficking, Mental Illness, and Addiction: Avoiding Diagnostic Overshadowing.

PubMed

Stoklosa, Hanni; MacGibbon, Marti; Stoklosa, Joseph

2017-01-01

This article reviews an emergency department-based clinical vignette of a trafficked patient with co-occurring pregnancy-related, mental health, and substance use disorder issues. The authors, including a survivor of human trafficking, draw on their backgrounds in addiction care, human trafficking, emergency medicine, and psychiatry to review the literature on relevant general health and mental health consequences of trafficking and propose an approach to the clinical complexities this case presents. In their discussion, the authors explicate the deleterious role of implicit bias and diagnostic overshadowing in trafficked patients with co-occurring addiction and mental illness. Finally, the authors propose a trauma-informed, multidisciplinary response to potentially trafficked patients. © 2017 American Medical Association. All Rights Reserved.

Walk-in clinics versus physician offices and emergency rooms for urgent care and chronic disease management.

PubMed

Chen, Connie E; Chen, Christopher T; Hu, Jia; Mehrotra, Ateev

2017-02-17

Walk-in clinics are growing in popularity around the world as a substitute for traditional medical care delivered in physician offices and emergency rooms, but their clinical efficacy is unclear. To assess the quality of care and patient satisfaction of walk-in clinics compared to that of traditional physician offices and emergency rooms for people who present with basic medical complaints for either acute or chronic issues. We searched CENTRAL, MEDLINE, Embase, six other databases, and two trials registers on 22 March 2016 together with reference checking, citation searching, and contact with study authors to identify additional studies. We applied no restrictions on language, publication type, or publication year. Study design: randomized trials, non-randomized trials, and controlled before-after studies. standalone physical clinics not requiring advance appointments or registration, that provided basic medical care without expectation of follow-up. Comparisons: traditional primary care practices or emergency rooms. We used standard methodological procedures expected by Cochrane and the Cochrane Effective Practice and Organisation of Care (EPOC) Group. The literature search identified 6587 citations, of which we considered 65 to be potentially relevant. We reviewed the abstracts of all 65 potentially relevant studies and retrieved the full texts of 12 articles thought to fit our study criteria. However, following independent author assessment of the full texts, we excluded all 12 articles. Controlled trial evidence about the mortality, morbidity, quality of care, and patient satisfaction of walk-in clinics is currently not available.

Going digital: a checklist in preparing for hospital-wide electronic medical record implementation and digital transformation.

PubMed

Scott, Ian A; Sullivan, Clair; Staib, Andrew

2018-05-24

Objective In an era of rapid digitisation of Australian hospitals, practical guidance is needed in how to successfully implement electronic medical records (EMRs) as both a technical innovation and a major transformative change in clinical care. The aim of the present study was to develop a checklist that clearly and comprehensively defines the steps that best prepare hospitals for EMR implementation and digital transformation. Methods The checklist was developed using a formal methodological framework comprised of: literature reviews of relevant issues; an interactive workshop involving a multidisciplinary group of digital leads from Queensland hospitals; a draft document based on literature and workshop proceedings; and a review and feedback from senior clinical leads. Results The final checklist comprised 19 questions, 13 related to EMR implementation and six to digital transformation. Questions related to the former included organisational considerations (leadership, governance, change leaders, implementation plan), technical considerations (vendor choice, information technology and project management teams, system and hardware alignment with clinician workflows, interoperability with legacy systems) and training (user training, post-go-live contingency plans, roll-out sequence, staff support at point of care). Questions related to digital transformation included cultural considerations (clinically focused vision statement and communication strategy, readiness for change surveys), management of digital disruption syndromes and plans for further improvement in patient care (post-go-live optimisation of digital system, quality and benefit evaluation, ongoing digital innovation). Conclusion This evidence-based, field-tested checklist provides guidance to hospitals planning EMR implementation and separates readiness for EMR from readiness for digital transformation. What is known about the topic? Many hospitals throughout Australia have implemented, or are planning to implement, hospital wide electronic medical records (EMRs) with varying degrees of functionality. Few hospitals have implemented a complete end-to-end digital system with the ability to bring about major transformation in clinical care. Although the many challenges in implementing EMRs have been well documented, they have not been incorporated into an evidence-based, field-tested checklist that can practically assist hospitals in preparing for EMR implementation as both a technical innovation and a vehicle for major digital transformation of care. What does this paper add? This paper outlines a 19-question checklist that was developed using a formal methodological framework comprising literature review of relevant issues, proceedings from an interactive workshop involving a multidisciplinary group of digital leads from hospitals throughout Queensland, including three hospitals undertaking EMR implementation and one hospital with complete end-to-end EMR, and review of a draft checklist by senior clinical leads within a statewide digital healthcare improvement network. The checklist distinguishes between issues pertaining to EMR as a technical innovation and EMR as a vehicle for digital transformation of patient care. What are the implications for practitioners? Successful implementation of a hospital-wide EMR requires senior managers, clinical leads, information technology teams and project management teams to fully address key operational and strategic issues. Using an issues checklist may help prevent any one issue being inadvertently overlooked or underemphasised in the planning and implementation stages, and ensure the EMR is fully adopted and optimally used by clinician users in an ongoing digital transformation of care.

Pharmacogenomics of CYP2C9: Functional and Clinical Considerations†

PubMed Central

Rettie, Allan E.; Fowler, Douglas M.; Miners, John O.

2017-01-01

CYP2C9 is the most abundant CYP2C subfamily enzyme in human liver and the most important contributor from this subfamily to drug metabolism. Polymorphisms resulting in decreased enzyme activity are common in the CYP2C9 gene and this, combined with narrow therapeutic indices for several key drug substrates, results in some important issues relating to drug safety and efficacy. CYP2C9 substrate selectivity is detailed and, based on crystal structures for the enzyme, we describe how CYP2C9 catalyzes these reactions. Factors relevant to clinical response to CYP2C9 substrates including inhibition, induction and genetic polymorphism are discussed in detail. In particular, we consider the issue of ethnic variation in pattern and frequency of genetic polymorphisms and clinical implications. Warfarin is the most well studied CYP2C9 substrate; recent work on use of dosing algorithms that include CYP2C9 genotype to improve patient safety during initiation of warfarin dosing are reviewed and prospects for their clinical implementation considered. Finally, we discuss a novel approach to cataloging the functional capabilities of rare ‘variants of uncertain significance’, which are increasingly detected as more exome and genome sequencing of diverse populations is conducted. PMID:29283396

Ethical implications of regenerative medicine in orthopedics: an empirical study with surgeons and scientists in the field.

PubMed

Niemansburg, Sophie L; van Delden, Johannes J M; Oner, F Cumhur; Dhert, Wouter J A; Bredenoord, Annelien L

2014-06-01

Regenerative medicine (RM) interventions, such as (stem) cell transplantation, scaffolds, gene transfer, and tissue engineering, are likely to change the field of orthopedics considerably. These strategies will significantly differ from treatments in current orthopedic practice, as they treat the underlying cause of disease and intervene at a biological level, preferably in an earlier stage. Whereas most of the RM interventions for orthopedics are still in the preclinical phase of research, the number of clinical studies is expected to increase rapidly in the future. The debate about the challenging scientific and ethical issues of translating these innovative interventions into (early) clinical studies is developing. However, no empirical studies that have systematically described the attitudes, opinions, and experiences of experts in the field of orthopedic RM concerning these challenges exist. The aim of this study was to identify ethical issues that experts in the area of RM for musculoskeletal disorders consider to be relevant to address so as to properly translate RM interventions into (early) clinical studies. In-depth qualitative interviews were conducted with 36 experts in the field, mainly spine surgeons and musculoskeletal scientists from The Netherlands and the United Kingdom. A topic list of open questions, based on existing literature and pilot interviews, was used to guide the interviews. Data analysis was based on the constant comparative method, which means going back and forth from the data to develop codes, concepts, and themes. Four ethical themes emerged from the interview data. First, the risks to study participants. Second, the appropriate selection of study participants. Third, setting relevant goal(s) for measuring outcome, varying from regenerating tissue to improving well-being of patients. Finally, the need for evidence-based medicine and scientific integrity, which is considered challenging in orthopedics. The overall attitude toward the development of RM was positive, especially because current surgical treatments for spine disorders lack satisfactory effectiveness. However, efforts should be taken to adequately address the ethical and scientific issues in the translation of RM interventions into clinical research. This is required to prevent unnecessary risks to study participants, to prevent exposure of future patients to useless clinical applications, as well as to prevent this young field from developing a negative reputation. Not only will the orthopedic RM field benefit from ethically and scientifically sound clinical studies, but the rise of RM also provides an opportunity to stimulate evidence-based practice in orthopedics and address hype- and profit-driven practices in orthopedics. Copyright © 2014 Elsevier Inc. All rights reserved.

Overview on Clinical Relevance of Intra-Tumor Heterogeneity.

PubMed

Stanta, Giorgio; Bonin, Serena

2018-01-01

Today, clinical evaluation of tumor heterogeneity is an emergent issue to improve clinical oncology. In particular, intra-tumor heterogeneity (ITH) is closely related to cancer progression, resistance to therapy, and recurrences. It is interconnected with complex molecular mechanisms including spatial and temporal phenomena, which are often peculiar for every single patient. This review tries to describe all the types of ITH including morphohistological ITH, and at the molecular level clonal ITH derived from genomic instability and nonclonal ITH derived from microenvironment interaction. It is important to consider the different types of ITH as a whole for any patient to investigate on cancer progression, prognosis, and treatment opportunities. From a practical point of view, analytical methods that are widely accessible today, or will be in the near future, are evaluated to investigate the complex pattern of ITH in a reproducible way for a clinical application.

Translating basic research into clinical practice or what else do we have to learn about olfactory ensheathing cells?

PubMed

Radtke, Christine; Wewetzer, Konstantin

2009-06-12

Olfactory ensheathing cells (OECs) are Schwann cell-like glial cells of the olfactory system that have been shown to promote axonal regeneration and remyelination in a variety of different lesion paradigms. It is still a matter of debate in how far OECs differ from Schwann cells regarding their regenerative potential and molecular setup. The fact that OECs have been already used for transplantation in humans may imply that the need of the hour is the fine-tuning of clinical application details rather than to cross the bridge between laboratory animal and man. Considering the therapeutic transplantation of OECs, however, the basic question to date is not 'how' to translate but rather 'what' to translate into clinical practice. The aim of the present article is to provide a summary of the current literature and to define the open issues relevant for translating basic research on OECs into clinical practice.

The Burn Wound Microenvironment

PubMed Central

Rose, Lloyd F.; Chan, Rodney K.

2016-01-01

Significance: While the survival rate of the severely burned patient has improved significantly, relatively little progress has been made in treatment or prevention of burn-induced long-term sequelae, such as contraction and fibrosis. Recent Advances: Our knowledge of the molecular pathways involved in burn wounds has increased dramatically, and technological advances now allow large-scale genomic studies, providing a global view of wound healing processes. Critical Issues: Translating findings from a large number of in vitro and preclinical animal studies into clinical practice represents a gap in our understanding, and the failures of a number of clinical trials suggest that targeting single pathways or cytokines may not be the best approach. Significant opportunities for improvement exist. Future Directions: Study of the underlying molecular influences of burn wound healing progression will undoubtedly continue as an active research focus. Increasing our knowledge of these processes will identify additional therapeutic targets, supporting informed clinical studies that translate into clinical relevance and practice. PMID:26989577

The role of prehealth student volunteers at a student-run free clinic in New York, United States.

PubMed

Shabbir, Syed H; Santos, Maria Teresa M

2015-01-01

The medical student-run Einstein Community Health Outreach Clinic provides free healthcare to the uninsured adult population of New York, the United States. During the summer, prehealth student volunteers are recruited to assist with clinic operations. We designed a survey study to identify the baseline characteristics of the volunteers between June and August of 2013 and 2014 in order to evaluate the influence of working in a medical student-run free clinic on their education, impressions, and career goals. A total of 38 volunteers (response rate, 83%) participated in the study. The volunteers were demographically diverse and interested in primary care specialties and community service. After the Einstein Community Health Outreach program, the volunteers showed an improved understanding of the healthcare process and issues relevant to uninsured patients. They also developed favorable attitudes towards primary care medicine and an increased level of interest in pursuing careers in primary care.

Is CT angiography of the pulmonary arteries indicated in patients with high clinical probability of pulmonary embolism?

PubMed

Martínez Montesinos, L; Plasencia Martínez, J M; García Santos, J M

When a diagnostic test confirms clinical suspicion, the indicated treatment can be administered. A problem arises when the diagnostic test does not confirm the initially suspected diagnosis; when the suspicion is grounded in clinically validated predictive rules and is high, the problem is even worse. This situation arises in up to 40% of patients with high suspicion for acute pulmonary embolism, raising the question of whether CT angiography of the pulmonary arteries should be done systematically. This paper reviews the literature about this issue and lays out the best evidence about the relevant recommendations for patients with high clinical suspicion of acute pulmonary embolism and negative findings on CT angiography. It also explains the probabilistic concepts derived from Bayes' theorem that can be useful for ascertaining the most appropriate approach in these patients. Copyright © 2017 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

The clinical development process for a novel preventive vaccine: An overview.

PubMed

Singh, K; Mehta, S

2016-01-01

Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.

Comparative evaluation of the drug interaction screening programs MediQ and ID PHARMA CHECK in neurological inpatients.

PubMed

Zorina, Olesya I; Haueis, Patrick; Semmler, Alexander; Marti, Isabelle; Gonzenbach, Roman R; Guzek, Markus; Kullak-Ublick, Gerd A; Weller, Michael; Russmann, Stefan

2012-08-01

The comparative evaluation of clinical decision support software (CDSS) programs regarding their sensitivity and positive predictive value for the identification of clinically relevant drug interactions. In this research, we used a cross-sectional study that identified potential drug interactions using the CDSS MediQ and the ID PHARMA CHECK in 484 neurological inpatients. Interactions were reclassified according to the Zurich Interaction System, a multidimensional classification that incorporates the Operational Classification of Drug Interactions. In 484 patients with 2812 prescriptions, MediQ and ID PHARMA CHECK generated a total of 1759 and 1082 alerts, respectively. MediQ identified 658 unique potentially interacting combinations, 8 classified as "high danger," 164 as "average danger," and 486 as "low danger." ID PHARMA CHECK detected 336 combinations assigned to one or several of 12 risk and management categories. Altogether, both CDSS issued alerts relating to 808 unique potentially interacting combinations. According to the Zurich Interaction System, 6 of these were contraindicated, 25 were provisionally contraindicated, 190 carried a conditional risk, and 587 had a minimal risk of adverse events. The positive predictive value for alerts having at least a conditional risk was 0.24 for MediQ and 0.48 for ID PHARMA CHECK. CDSS showed major differences in the identification and grading of interactions, and many interactions were only identified by one of the two CDSS. For both programs, only a small proportion of all identified interactions appeared clinically relevant, and the selected display of alerts that imply management changes is a key issue in the further development and local setup of such programs. Copyright © 2012 John Wiley & Sons, Ltd.

Issue-Relevant Values and Opinions About Gay Rights: Beyond Equality and Morality.

PubMed

Rhodebeck, Laurie

2018-01-01

Although many studies have examined the role of values in shaping public opinion, the number of values that inform this research is limited. This article employs the concept of issue-relevant values as a means to explore the broader range of values associated with policy issues. After discussing the concept in general terms, the article explores issue-relevant values pertinent to public opinion about gay rights. Using the policy examples of employment nondiscrimination and same-sex couple adoption, the present study identifies, measures, and assesses several values that add to the very short list previously used to explain public opinion about gay rights issues. Content from interest-group Web sites and news media coverage of the two issues aided in identifying the values. Data from an original Internet survey yield valid measures of the values. Multivariate analyses indicate that the values behave in predictable ways: they are strongly influenced by partisanship, and they strongly affect opinions about the two issues. The performance of the values is consistent with findings from previous research on the partisan basis of values and the value-based nature of opinions. The article concludes with suggestions for further empirical and theoretical work that could apply and extend the concept of issue-relevant values.

Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster.

PubMed

Liedert, B; Bassus, S; Schneider, C K; Kalinke, U; Löwer, J

2007-01-01

This review summarizes scientific, ethical and regulatory aspects of Phase I clinical trials with monoclonal antibodies. The current standard requirements for pre-clinical testing and for clinical study design are presented. The scientific considerations discussed herein are generally applicable, the view on legal requirements for clinical trials refer to the German jurisdiction only. The adverse effects associated with the TGN1412 Phase I trial indicate that the predictive value of pre-clinical animal models requires reevaluation and that, in certain cases, some issues of clinical trial protocols such as dose fixing may need refinement or redesign. Concrete safety measures, which have been proposed as a consequence of the TGN1412 event include introduction of criteria for high-risk antibodies, sequential inclusion of trial participants and implementation of pre-Phase I studies where dose calculation is based on the pre-clinical No Effect Level instead of the No Observed Adverse Effect Level. The recently established European clinical trials database (EUDRACT Database) is a further safety tool to expedite the sharing of relevant information between scientific authorities.

Validation of a new classification for periprosthetic shoulder fractures.

PubMed

Kirchhoff, Chlodwig; Beirer, Marc; Brunner, Ulrich; Buchholz, Arne; Biberthaler, Peter; Crönlein, Moritz

2018-06-01

Successful treatment of periprosthetic shoulder fractures depends on the right strategy, starting with a well-structured classification of the fracture. Unfortunately, clinically relevant factors for treatment planning are missing in the pre-existing classifications. Therefore, the aim of the present study was to describe a new specific classification system for periprosthetic shoulder fractures including a structured treatment algorithm for this important fragility fracture issue. The classification was established, focussing on five relevant items, naming the prosthesis type, the fracture localisation, the rotator cuff status, the anatomical fracture region and the stability of the implant. After considering each single item, the individual treatment concept can be assessed in one last step. To evaluate the introduced classification, a retrospective analysis of pre- and post-operative data of patients, treated with periprosthetic shoulder fractures, was conducted by two board certified trauma surgery consultants. The data of 19 patients (8 male, 11 female) with a mean age of 74 ± five years have been analysed in our study. The suggested treatment algorithm was proven to be reliable, detected by good clinical outcome in 15 of 16 (94%) cases, where the suggested treatment was maintained. Only one case resulted in poor outcome due to post-operative wound infection and had to be revised. The newly developed six-step classification is easy to utilise and extends the pre-existing classification systems in terms of clinically-relevant information. This classification should serve as a simple tool for the surgeon to consider the optimal treatment for his patients.

Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases.

PubMed

Filippatos, Gerasimos S; de Graeff, Pieter; Bax, Jeroen J; Borg, John-Joseph; Cleland, John G F; Dargie, Henry J; Flather, Marcus; Ford, Ian; Friede, Tim; Greenberg, Barry; Henon-Goburdhun, Cécile; Holcomb, Richard; Horst, Bradley; Lekakis, John; Mueller-Velten, Guenther; Papavassiliou, Athanasios G; Prasad, Krishna; Rosano, Giuseppe M C; Severin, Thomas; Sherman, Warren; Stough, Wendy Gattis; Swedberg, Karl; Tavazzi, Luigi; Tousoulis, Dimitris; Vardas, Panagiotis; Ruschitzka, Frank; Anker, Stefan D

2017-04-01

Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity. Generally accepted standards exist for DMC composition and operational conduct. However, some relevant issues are not specifically addressed in current guidance documents, resulting in uncertainties regarding optimal approaches for communication between the DMC, steering committee, and sponsors, release of information, and liability protection for DMC members. The Heart Failure Association (HFA) of the European Society of Cardiology (ESC), in collaboration with the Clinical Trials Unit of the European Heart Agency (EHA) of the ESC convened a meeting of international experts in DMCs for cardiovascular and cardiometabolic clinical trials to identify specific issues and develop steps to resolve challenges faced by DMCs.The main recommendations from the meeting relate to methodological consistency, independence, managing conflicts of interest, liability protection, and training of future DMC members. This paper summarizes the key outcomes from this expert meeting, and describes the core set of activities that might be further developed and ultimately implemented by the ESC, HFA, and other interested ESC constituent bodies. The HFA will continue to work with stakeholders in cardiovascular and cardiometabolic clinical research to promote these goals. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

PubMed

Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

2018-02-01

Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Enzalutamide for the treatment of prostate cancer

PubMed Central

Pal, Sumanta K.; Stein, Cy A.; Sartor, Oliver

2013-01-01

Introduction The FDA approval of docetaxel for metastatic castration-resistant prostate cancer (mCRPC) in 2005 marked a major milestone – as it was the first approved agent for this disease that demonstrated a survival advantage in phase III assessment in this disease. Since 2009, several other agents have been FDA approved, including sipuleucel-T, abiraterone, cabazitaxel and enzalutamide. Enzalutamide, a potent antiandrogen that blocks nuclear translocation of the androgen receptor (AR) is the most recently approved of these agents. Areas Covered The clinical development of enzalutamide is discussed, with attention given as to how this agent will most appropriately be used among a growing list of agents for mCRPC. A MEDLINE search was conducted to identify all relevant published datasets pertaining to the drug. In addition, relevant ASCO and ESMO abstracts were searched. Expert Opinion The current role and sequencing of enzalutamide may change drastically based on studies such as PREVAIL (a phase III pre-chemotherapy assessment of enzalutamide) and planned studies to assess relevant combinations (i.e., enzalutamide with abiraterone). Outside of clinical efficacy, issues such as drug cost may ultimately dictate our utilization of agents such as enzalutamide for mCPRC. Although the development of biomarkers to guide therapy for mCRPC is ideal, there are inherent challenges in establishing biomarker-driven treatment. PMID:23441761

A Proposal of the European Association for the Study of Obesity to Improve the ICD-11 Diagnostic Criteria for Obesity Based on the Three Dimensions Etiology, Degree of Adiposity and Health Risk

PubMed Central

Hebebrand, Johannes; Holm, Jens-Christian; Woodward, Euan; Baker, Jennifer Lyn; Blaak, Ellen; Schutz, Dominique Durrer; Farpour-Lambert, Nathalie J.; Frühbeck, Gema; Halford, Jason G.C.; Lissner, Lauren; Micic, Dragan; Mullerova, Dana; Roman, Gabriela; Schindler, Karin; Toplak, Hermann; Visscher, Tommy L.S.; Yumuk, Volkan

2017-01-01

Diagnostic criteria for complex medical conditions caused by a multitude of both genetic and environmental factors should be descriptive and avoid any attribution of causality. Furthermore, the wording used to describe a disorder should be evidence-based and avoid stigmatization of the affected individuals. Both terminology and categorizations should be readily comprehensible for healthcare professionals and guide clinical decision making. Uncertainties with respect to diagnostic issues and their implications may be addressed to direct future clinical research. In this context, the European Association of the Study of Obesity (EASO) considers it an important endeavor to review the current ICD-11 Beta Draft for the definition of overweight and obesity and to propose a substantial revision. We aim to provide an overview of the key issues that we deem relevant for the discussion of the diagnostic criteria. We first discuss the current ICD-10 criteria and those proposed in the ICD 11 Beta Draft. We conclude with our own proposal for diagnostic criteria, which we believe will improve the assessment of patients with obesity in a clinically meaningful way. PMID:28738325

EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti‐neutrophil cytoplasm antibody‐associated vasculitis

PubMed Central

Hellmich, Bernhard; Flossmann, Oliver; Gross, Wolfgang L; Bacon, Paul; Cohen‐Tervaert, Jan Willem; Guillevin, Loic; Jayne, David; Mahr, Alfred; Merkel, Peter A; Raspe, Heiner; Scott, David G I; Witter, James; Yazici, Hasan; Luqmani, Raashid A

2007-01-01

Objectives To develop the European League Against Rheumatism (EULAR) recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis. Methods An expert consensus group was formed consisting of rheumatologists, nephrologists and specialists in internal medicine representing five European countries and the USA, a clinical epidemiologist and representatives from regulatory agencies. Using an evidence‐based and expert opinion‐based approach in accordance with the standardised EULAR operating procedures, the group identified nine topics for a systematic literature search through a modified Delphi technique. On the basis of research questions posed by the group, recommendations were derived for conducting clinical studies and/or clinical trials in systemic vasculitis. Results Based on the results of the literature research, the expert committee concluded that sufficient evidence to formulate guidelines on conducting clinical trials was available only for anti‐neutrophil cytoplasm antibody‐associated vasculitides (AAV). It was therefore decided to focus the recommendations on these diseases. Recommendations for conducting clinical trials in AAV were elaborated and are presented in this summary document. It was decided to consider vasculitis‐specific issues rather than general issues of trial methodology. The recommendations deal with the following areas related to clinical studies of vasculitis: definitions of disease, activity states, outcome measures, eligibility criteria, trial design including relevant end points, and biomarkers. A number of aspects of trial methodology were deemed important for future research. Conclusions On the basis of expert opinion, recommendations for conducting clinical trials in AAV were formulated. Furthermore, the expert committee identified a strong need for well‐designed research in non‐AAV systemic vasculitides. PMID:17170053

[Research and development strategies in classical herbal formulae].

PubMed

Chen, Chang; Cheng, Jin-Tang; Liu, An

2017-05-01

As an outstanding representative of traditional Chinese medicine prescription, classical herbal formulae are the essence of traditional Chinese medicine great treasure. To support the development of classical herbal formulae, the state and relevant administrative departments have successively promulgated the relevant encouraged policies.But some key issues of classic herbal formulae in the development process have not reached a unified consensus and standard, and these problems were discussed in depth here.The authors discussed the registration requirements of classical herbal formulae, proposed the screening specific indicators of classical herbal formulae, determination basis of prescription and dosage,screening method of production process, and the basic principle of clinical localization, in order to bring out valuable opinions and provide a reference for classical herbal formulae development and policy formulation. Copyright© by the Chinese Pharmaceutical Association.

BIOPHYSICAL PROPERTIES OF NUCLEIC ACIDS AT SURFACES RELEVANT TO MICROARRAY PERFORMANCE.

PubMed

Rao, Archana N; Grainger, David W

2014-04-01

Both clinical and analytical metrics produced by microarray-based assay technology have recognized problems in reproducibility, reliability and analytical sensitivity. These issues are often attributed to poor understanding and control of nucleic acid behaviors and properties at solid-liquid interfaces. Nucleic acid hybridization, central to DNA and RNA microarray formats, depends on the properties and behaviors of single strand (ss) nucleic acids (e.g., probe oligomeric DNA) bound to surfaces. ssDNA's persistence length, radius of gyration, electrostatics, conformations on different surfaces and under various assay conditions, its chain flexibility and curvature, charging effects in ionic solutions, and fluorescent labeling all influence its physical chemistry and hybridization under assay conditions. Nucleic acid (e.g., both RNA and DNA) target interactions with immobilized ssDNA strands are highly impacted by these biophysical states. Furthermore, the kinetics, thermodynamics, and enthalpic and entropic contributions to DNA hybridization reflect global probe/target structures and interaction dynamics. Here we review several biophysical issues relevant to oligomeric nucleic acid molecular behaviors at surfaces and their influences on duplex formation that influence microarray assay performance. Correlation of biophysical aspects of single and double-stranded nucleic acids with their complexes in bulk solution is common. Such analysis at surfaces is not commonly reported, despite its importance to microarray assays. We seek to provide further insight into nucleic acid-surface challenges facing microarray diagnostic formats that have hindered their clinical adoption and compromise their research quality and value as genomics tools.

BIOPHYSICAL PROPERTIES OF NUCLEIC ACIDS AT SURFACES RELEVANT TO MICROARRAY PERFORMANCE

PubMed Central

Rao, Archana N.; Grainger, David W.

2014-01-01

Both clinical and analytical metrics produced by microarray-based assay technology have recognized problems in reproducibility, reliability and analytical sensitivity. These issues are often attributed to poor understanding and control of nucleic acid behaviors and properties at solid-liquid interfaces. Nucleic acid hybridization, central to DNA and RNA microarray formats, depends on the properties and behaviors of single strand (ss) nucleic acids (e.g., probe oligomeric DNA) bound to surfaces. ssDNA’s persistence length, radius of gyration, electrostatics, conformations on different surfaces and under various assay conditions, its chain flexibility and curvature, charging effects in ionic solutions, and fluorescent labeling all influence its physical chemistry and hybridization under assay conditions. Nucleic acid (e.g., both RNA and DNA) target interactions with immobilized ssDNA strands are highly impacted by these biophysical states. Furthermore, the kinetics, thermodynamics, and enthalpic and entropic contributions to DNA hybridization reflect global probe/target structures and interaction dynamics. Here we review several biophysical issues relevant to oligomeric nucleic acid molecular behaviors at surfaces and their influences on duplex formation that influence microarray assay performance. Correlation of biophysical aspects of single and double-stranded nucleic acids with their complexes in bulk solution is common. Such analysis at surfaces is not commonly reported, despite its importance to microarray assays. We seek to provide further insight into nucleic acid-surface challenges facing microarray diagnostic formats that have hindered their clinical adoption and compromise their research quality and value as genomics tools. PMID:24765522

From Systems Understanding to Personalized Medicine: Lessons and Recommendations Based on a Multidisciplinary and Translational Analysis of COPD.

PubMed

Roca, Josep; Cano, Isaac; Gomez-Cabrero, David; Tegnér, Jesper

2016-01-01

Systems medicine, using and adapting methods and approaches as developed within systems biology, promises to be essential in ongoing efforts of realizing and implementing personalized medicine in clinical practice and research. Here we review and critically assess these opportunities and challenges using our work on COPD as a case study. We find that there are significant unresolved biomedical challenges in how to unravel complex multifactorial components in disease initiation and progression producing different clinical phenotypes. Yet, while such a systems understanding of COPD is necessary, there are other auxiliary challenges that need to be addressed in concert with a systems analysis of COPD. These include information and communication technology (ICT)-related issues such as data harmonization, systematic handling of knowledge, computational modeling, and importantly their translation and support of clinical practice. For example, clinical decision-support systems need a seamless integration with new models and knowledge as systems analysis of COPD continues to develop. Our experience with clinical implementation of systems medicine targeting COPD highlights the need for a change of management including design of appropriate business models and adoption of ICT providing and supporting organizational interoperability among professional teams across healthcare tiers, working around the patient. In conclusion, in our hands the scope and efforts of systems medicine need to concurrently consider these aspects of clinical implementation, which inherently drives the selection of the most relevant and urgent issues and methods that need further development in a systems analysis of disease.

Establishing HIV treatment as prevention in the HIV Prevention Trials Network 052 randomized trial: an ethical odyssey.

PubMed

Cohen, Myron S; McCauley, Marybeth; Sugarman, Jeremy

2012-06-01

Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HIV Prevention Trials Network (HPTN) 052, the multinational clinical trial addressing this issue that has profound public health implications. To describe and analyze the major ethical challenges faced in HPTN 052. The ethical issues and modifications of HPTN 052 in response to these issues were cataloged by the principal investigator, the lead coordinator, and the ethicist working on the trial. The major ethical issues that were unique to the trial were then described and analyzed in light of the published literature as well as guidances and policies. The ethical challenges that must be addressed in many clinical trials, such as those related to obtaining informed consent and making provisions for ancillary care, are not described. When HPTN 052 was being designed, ethical questions emerged related to the relevance of the research question itself given data from observational research and a range of beliefs about the appropriate means of preventing and treating HIV infection and AIDS. Furthermore, ethical challenges were faced regarding site selection since there was a scientific need to conduct the research in settings where HIV incidence was high, but alternatives to study participation should be available. As in most HIV-prevention research, ethical questions surrounded the determination of the appropriate prevention package for all of those enrolled. During the course of the trial, guidance documents and policies emerged that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity. When the study results were made public, there was a need to ensure access to the treatment shown to be effective that in some cases differed from the guidelines used at the sites where the research was being conducted. In addition, questions were raised about whether there was an obligation to notify subjects about 'unlinked' transmissions of HIV, that is, infections acquired from someone other than the designated sexual partner enrolled in the study. The ethical issues described are limited to those discerned by the authors and not those of other stakeholders who may have identified additional issues or had a different perspective in analyzing them. Understanding the ethical challenges faced in HPTN 052 promises to inform the design and conduct of future complex, long-term clinical trials aimed at addressing critical scientific and public health questions, where data and practice patterns emerge over the course of the trial.

Overseas trained nurses working in regional and rural practice settings: do we understand the issues?

PubMed

Wellard, S J; Stockhausen, L J

2010-01-01

Issues associated with the employment of overseas trained nurses (OTNs) in regional and rural practice settings have received little professional attention in Australia. The global nursing workforce crisis has dominated discussion about the migration of nurses. This review explored the contemporary understandings of the employment of OTNs in Australian regional and rural practice settings. An integrative literature review was undertaken to incorporate a range of literature types related to OTN employment. A search of electronic databases and relevant web pages was undertaken for the publication period 1995-2008. Integrative literature reviews incorporate assessment of empirical research as well as theoretical and opinion-based literature to present a broad synthesis of the topic of interest. Following identification of relevant literature, thematic analysis was undertaken to reveal patterns and relationships among concepts facilitating synthesis of findings across the range of literature. There is an abundance of literature exploring the international migration of nurses that demonstrates an imbalance of migration from poorer countries to more affluent countries. This review identified a number of economic and ethical issues, together with risks for potential exploitation of migrant nurses. There was minimal literature specific to the experiences of OTNs working in regional and rural areas. However, there has been some exploration of issues associated with medical recruitment to rural areas. The employment of OTNs is accompanied by complex and varied issues which require resourceful and proactive responses by healthcare employers. Further research is needed to understand the challenges OTNs have in working in rural settings, particularly in Australia. Increased understanding in clinical settings of factors that influence nurses to migrate, as well as the range of barriers they face in working and living in host countries, may assist in the retention of these nurses.

Shifting Liberal and Conservative Attitudes Using Moral Foundations Theory

PubMed Central

Day, Martin V.; Fiske, Susan T.; Downing, Emily L.; Trail, Thomas E.

2016-01-01

People’s social and political opinions are grounded in their moral concerns about right and wrong. We examine whether five moral foundations—harm, fairness, ingroup, authority, and purity—can influence political attitudes of liberals and conservatives across a variety of issues. Framing issues using moral foundations may change political attitudes in at least two possible ways: 1. Entrenching: relevant moral foundations will strengthen existing political attitudes when framing pro-attitudinal issues (e.g., conservatives exposed to a free-market economic stance). 2. Persuasion: mere presence of relevant moral foundations may also alter political attitudes in counter-attitudinal directions (e.g., conservatives exposed to an economic regulation stance). Studies 1 and 2 support the entrenching hypothesis. Relevant moral foundation-based frames bolstered political attitudes for conservatives (Study 1) and liberals (Study 2). Only Study 2 partially supports the persuasion hypothesis. Conservative-relevant moral frames of liberal issues increased conservatives’ liberal attitudes. PMID:25286912

Space Station Engineering Design Issues

NASA Technical Reports Server (NTRS)

Mcruer, Duane T.; Boehm, Barry W.; Debra, Daniel B.; Green, C. Cordell; Henry, Richard C.; Maycock, Paul D.; Mcelroy, John H.; Pierce, Chester M.; Stafford, Thomas P.; Young, Laurence R.

1989-01-01

Space Station Freedom topics addressed include: general design issues; issues related to utilization and operations; issues related to systems requirements and design; and management issues relevant to design.

Systems pharmacology augments drug safety surveillance

PubMed Central

Lorberbaum, Tal; Nasir, Mavra; Keiser, Michael J.; Vilar, Santiago; Hripcsak, George; Tatonetti, Nicholas P.

2014-01-01

Small molecule drugs are the foundation of modern medical practice yet their use is limited by the onset of unexpected and severe adverse events (AEs). Regulatory agencies rely on post-marketing surveillance to monitor safety once drugs are approved for clinical use. Despite advances in pharmacovigilance methods that address issues of confounding bias, clinical data of AEs are inherently noisy. Systems pharmacology– the integration of systems biology and chemical genomics – can illuminate drug mechanisms of action. We hypothesize that these data can improve drug safety surveillance by highlighting drugs with a mechanistic connection to the target phenotype (enriching true positives) and filtering those that do not (depleting false positives). We present an algorithm, the modular assembly of drug safety subnetworks (MADSS), to combine systems pharmacology and pharmacovigilance data and significantly improve drug safety monitoring for four clinically relevant adverse drug reactions. PMID:25670520

Big data in healthcare - the promises, challenges and opportunities from a research perspective: A case study with a model database.

PubMed

Adibuzzaman, Mohammad; DeLaurentis, Poching; Hill, Jennifer; Benneyworth, Brian D

2017-01-01

Recent advances in data collection during routine health care in the form of Electronic Health Records (EHR), medical device data (e.g., infusion pump informatics, physiological monitoring data, and insurance claims data, among others, as well as biological and experimental data, have created tremendous opportunities for biological discoveries for clinical application. However, even with all the advancement in technologies and their promises for discoveries, very few research findings have been translated to clinical knowledge, or more importantly, to clinical practice. In this paper, we identify and present the initial work addressing the relevant challenges in three broad categories: data, accessibility, and translation. These issues are discussed in the context of a widely used detailed database from an intensive care unit, Medical Information Mart for Intensive Care (MIMIC III) database.

Investing in nursing research in practice settings: a blueprint for building capacity.

PubMed

Jeffs, Lianne; Smith, Orla; Beswick, Susan; Maoine, Maria; Ferris, Ella

2013-12-01

Engaging clinical nurses in practice-based research is a cornerstone of professional nursing practice and a critical element in the delivery of high-quality patient care. Practising staff nurses are well suited to identify the phenomena and issues that are clinically relevant and appropriate for research. In response to the need to invest in and build capacity in nursing research, hospitals have developed creative approaches to spark interest in nursing research and to equip clinical nurses with research competencies. This paper outlines a Canadian hospital's efforts to build research capacity as a key strategy to foster efficacious, safe and cost-effective patient care practices. Within a multi-pronged framework, several strategies are described that collectively resulted in enhanced research and knowledge translation productivity aimed at improving the delivery of safe and high-quality patient care.

Clinical cultural competency and knowledge of health disparities among pharmacy students.

PubMed

Okoro, Olihe N; Odedina, Folakemi T; Reams, Romonia R; Smith, W Thomas

2012-04-10

To evaluate the level of competency and knowledge about health disparities among third-year doctor of pharmacy (PharmD) students at 2 Florida public colleges of pharmacy and to explore the demographic correlates of these variables. A cross-sectional survey study design was used to collect data from participants. The students had low health-disparities knowledge and moderate skills in dealing with sociocultural issues and cross-cultural encounters. Speaking a language(s) other than English and having exposure to cultural-competency instruction were the demographic variables found to be most significantly associated with clinical cultural competency and/or knowledge of health disparities. Clinical cultural competency and health-disparities instruction may not be adequately incorporated into the pharmacy school curricula in the institutions studied. Relevant education and training are necessary to enhance cultural competency among pharmacy students.

Transfer of knowledge and skills: some implications for nursing and nurse education.

PubMed

Lauder, W; Reynolds, W; Angus, N

1999-08-01

The construct of transfer has enormous importance to nursing as it begins to highlight potential problems in the transfer of knowledge and skills from the campus to the clinical area, from one part of the clinical area to another (e.g. surgical to medical), and from community to the clinical area. Thus, any adequate conceptualization of transfer must account for problems of practice-practice transfer as well as theory-practice transfer. These potential problems are the concern of educators, students and managers who have a responsibility for agency nurses and bank nurses who may find themselves in different specialities on a regular basis. Transfer has relevance to a whole raft of other issues ranging from the application of theories to nursing practice, through to the validity of claims that courses which develop intellectual skills prepare nurses for lifelong learning.

Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

PubMed

Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F

2015-12-01

The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by institutional structures for the clinical practice of EEG NF. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Integration and timing of basic and clinical sciences education.

PubMed

Bandiera, Glen; Boucher, Andree; Neville, Alan; Kuper, Ayelet; Hodges, Brian

2013-05-01

Medical education has traditionally been compartmentalized into basic and clinical sciences, with the latter being viewed as the skillful application of the former. Over time, the relevance of basic sciences has become defined by their role in supporting clinical problem solving rather than being, of themselves, a defining knowledge base of physicians. As part of the national Future of Medical Education in Canada (FMEC MD) project, a comprehensive empirical environmental scan identified the timing and integration of basic sciences as a key pressing issue for medical education. Using the literature review, key informant interviews, stakeholder meetings, and subsequent consultation forums from the FMEC project, this paper details the empirical basis for focusing on the role of basic science, the evidentiary foundations for current practices, and the implications for medical education. Despite a dearth of definitive relevant studies, opinions about how best to integrate the sciences remain strong. Resource allocation, political power, educational philosophy, and the shift from a knowledge-based to a problem-solving profession all influence the debate. There was little disagreement that both sciences are important, that many traditional models emphasized deep understanding of limited basic science disciplines at the expense of other relevant content such as social sciences, or that teaching the sciences contemporaneously rather than sequentially has theoretical and practical merit. Innovations in integrated curriculum design have occurred internationally. Less clear are the appropriate balance of the sciences, the best integration model, and solutions to the political and practical challenges of integrated curricula. New curricula tend to emphasize integration, development of more diverse physician competencies, and preparation of physicians to adapt to evolving technology and patients' expectations. Refocusing the basic/clinical dichotomy to a foundational/applied model may yield benefits in training widely competent future physicians.

Quality of life and economic burdens of malocclusion in U.S. patients enrolled in Medicaid.

PubMed

Bresnahan, Brian W; Kiyak, H Asuman; Masters, Samuel H; McGorray, Susan P; Lincoln, Adam; King, Gregory

2010-10-01

Patients enrolled in Medicaid have limited access to orthodontic services in the United States. No studies are available, to the authors' knowledge, regarding the clinical and psychosocial burdens of malocclusion on these patients from an economic perspective. The authors conducted a systematic review of the relevant economic literature. They identified issues from the perspectives of the various stakeholders (dentists, patients and parents, Medicaid programs) and developed a conceptual model for studying decision making focused on the strategy of providing early interceptive and preventive treatment rather than, or in addition to, comprehensive care in the patient's permanent dentition. Medicaid coverage and reimbursement amounts vary nationwide, and decision making associated with obtaining care can be complex. The perspectives of all relevant stakeholders deserve assessment. A conceptual framework of the cost-effectiveness of interceptive orthodontic treatment compared with comprehensive treatment illustrates the issues to be considered when evaluating these strategies. Policymakers and the dental community should identify creative solutions to addressing low-income families' limited access to orthodontic services and compare them from various perspectives with regard to their relative cost-effectiveness. Dentists should be aware of the multiple problems faced by low-income families in obtaining orthodontic services and the impact of stakeholder issues on access to care; they also should be proactive in helping low-income patients obtain needed orthodontic services.

[Characteristics of clinical trials in Hungary based on the analysis of an international database].

PubMed

Tóth, Tamás; Pollner, Péter; Palla, Gergely; Dinya, Elek

2017-03-01

Intorduction: The ClinicalTrials.gov website, which is operated by the US government, collects data about clinical trials. We have processed data related to Hungary by downloading from the website as XML files. Most of the data describe trials performed after 2000, so we got an overview about the clinical research of the last 10 to 15 years. As the majority of the data fields are collected as free text, significant data cleaning was needed. The database contained 2863 trials related to Hungary from 189 settlements. Only 20 per cent of the actual research organizations could have been identified as many times only an "id" number or a general name was given, thus this information was anonymised in many cases. Besides the analysis of the information obtained from this database, our study points out the relevant issues that may influence the international view of the Hungarian clinical research. Orv. Hetil., 2017, 158(9), 345-351.

Clinical research in small genomically stratified patient populations.

PubMed

Martin-Liberal, J; Rodon, J

2017-07-01

The paradigm of early drug development in cancer is shifting from 'histology-oriented' to 'molecularly oriented' clinical trials. This change can be attributed to the vast amount of tumour biology knowledge generated by large international research initiatives such as The Cancer Genome Atlas (TCGA) and the use of next generation sequencing (NGS) techniques developed in recent years. However, targeting infrequent molecular alterations entails a series of special challenges. The optimal molecular profiling method, the lack of standardised biological thresholds, inter- and intra-tumor heterogeneity, availability of enough tumour material, correct clinical trials design, attrition rate, logistics or costs are only some of the issues that need to be taken into consideration in clinical research in small genomically stratified patient populations. This article examines the most relevant challenges inherent to clinical research in these populations. Moreover, perspectives from the Academia point of view are reviewed as well as initiatives to be taken in forthcoming years. Copyright © 2017 Elsevier Ltd. All rights reserved.

Recent Developments in Dystonia

PubMed Central

Jinnah, H. A.; Teller, Jan K.; Galpern, Wendy R.

2015-01-01

Purpose of review The dystonias are a family of related disorders with many different clinical manifestations and causes. This review summarizes recent developments regarding these disorders, focusing mainly on advances with direct clinical relevance from the past two years. Recent findings The dystonias are generally defined by their clinical characteristics, rather than by their underlying genetic or neuropathological defects. The many varied clinical manifestations and causes contribute to the fact that they are one of the most poorly recognized of all movement disorders. A series of recent publications has addressed these issues offering a revised definition and more logical means for classifying the many subtypes. Our understanding of the genetic and neurobiological mechanisms responsible for different types of dystonias also has grown rapidly, creating new opportunities and challenges for diagnosis and identifying increasing numbers of rare subtypes for which specific treatments are available. Summary Recent advances in describing the clinical phenotypes and determining associated genotypes have pointed to the need for new strategies for diagnosis, classification and treatment of the dystonias. PMID:26110799

Psychiatrists and termination of pregnancy: clinical, legal and ethical aspects.

PubMed

Morris, Kirsty; Savell, Kristin; Ryan, Christopher J

2012-01-01

To provide practical guidance for psychiatrists asked to conduct an assessment of a woman requesting a termination of pregnancy. The law relevant to termination of pregnancy in each of the Australian states and territories and in New Zealand was synthesised and reviewed, as was the available literature around the key roles for the psychiatrist in these settings. Little is known about the rates of and reasons for terminations in Australasia. The 'lawfulness' of termination varies between jurisdictions and might require a consideration of the woman's mental health. When psychiatrists are asked to assist, their roles can be divided into: assessment and management of the woman's mental health, assessment of the woman's capacity to consent to the termination, assessment of the impact of having a termination or not having a termination upon the woman's mental health, assistance in determining the lawfulness of the proposed termination and, finally, support of the obstetric team providing terminations. The psychiatric assessment of a woman requesting a termination of pregnancy requires an understanding of the ethical issues, the relevant law and a clinical framework within which the psychiatrist can delineate his or her various roles.

Clinical relevance in anesthesia journals.

PubMed

Lauritsen, Jakob; Møller, Ann M

2006-04-01

The purpose of this review is to present the latest knowledge and research on the definition and distribution of clinically relevant articles in anesthesia journals. It will also discuss the importance of the chosen methodology and outcome of articles. In the last few years, more attention has been paid to evidence-based medicine in anesthesia. Several articles on the subject have focused on the need to base clinical decisions on sound research employing both methodological rigor and clinically relevant outcomes. The number of systematic reviews in anesthesia literature is increasing as well as the focus on diminishing the number of surrogate outcomes. It has been shown that the impact factor is not a valid measure of establishing the level of clinical relevance to a journal. This review presents definitions of clinically relevant anesthesia articles. A clinically relevant article employs both methodological rigor and a clinically relevant outcome. The terms methodological rigor and clinical outcomes are fully discussed in the review as well as problems with journal impact factors.

Cyclooxygenase inhibitors: From pharmacology to clinical read-outs.

PubMed

Patrignani, Paola; Patrono, Carlo

2015-04-01

Acetylsalicylic acid (aspirin) is a prototypic cyclooxygenase (COX) inhibitor. It was synthesized serendipitously from a natural compound, i.e., salicylic acid, with known analgesic activity. This chemical modification, obtained for the first time in an industrial environment in 1897, endowed aspirin with the unique capacity of acetylating and inactivating permanently COX-isozymes. Traditional nonsteroidal anti-inflammatory drugs (tNSAIDs) were developed to mimic the pharmacological effects of aspirin, using aspirin-sensitive experimental models of pain and inflammation as the template for screening new chemical entities. Among the tNSAIDs, some were endowed with moderate COX- selectivity (e.g., diclofenac), but no studies of sufficient size and duration were performed to show any clinically relevant difference between different members of the class. Similarly, no serious attempts were made to unravel the mechanisms involved in the shared therapeutic and toxic effects of tNSAIDs until the discovery of COX-2. This led to characterizing their main therapeutic effects as being COX-2-dependent and their gastrointestinal (GI) toxicity as being COX-1-dependent, and provided a rationale for developing a new class of selective COX-2 inhibitors, the coxibs. This review will discuss the clinical pharmacology of tNSAIDs and coxibs, and the clinical read-outs of COX-isozyme inhibition. This article is part of a Special Issue entitled "Oxygenated metabolism of PUFA: analysis and biological relevance." Copyright © 2014 Elsevier B.V. All rights reserved.

Modern Advances in Genetic Testing: Ethical Challenges and Training Implications for Current and Future Psychologists

PubMed Central

Richmond-Rakerd, Leah S.

2014-01-01

The ethical implications for psychological practice of genetic testing are largely unexplored. Predictive testing can have a significant impact on health and well-being, and increasing numbers of individuals with knowledge of their risk for various disorders are likely to present for psychotherapy. In addition, more people will struggle with the decision of whether to obtain information regarding their genetic material. Psychologists will need to have the appropriate knowledge and clinical skills to effectively counsel this population. This article highlights the relevant ethical issues surrounding psychological treatment of individuals pursuing or considering undergoing genetic testing. These issues are extended to psychologists working in research, education, and policy domains. Recommendations for graduate training programs to facilitate current and future practitioner competence are also discussed. PMID:24707160

Before the experts arrive.

PubMed

Chandley, M

2001-06-01

This article addresses the rare event of the hostage situation in a forensic psychiatric nursing setting. It has a specific focus on the initial response and the accompanying issues for nurses at the clinical interface as the situation emerges. The intention of this article is to both offer guidance and raise the profile of this unique management issue because little attention is drawn to early-stage hostage situations at an organizational level. When a hostage situation occurs, inadequate preparation can mean the difference between life and death for the hostage, negotiator, or hostage taker. This article provides an overview of the relevant literature and offers guidance about the actions required when a nurse suddenly becomes responsible for managing the early stages of such a traumatic event. Responses, safety, and communication factors concerning the hostage taker are covered.

Postapproval Development Options in COPD: A Case Study in Value-Based Healthcare Systems.

PubMed

Murphy, Michael F; Antonini, Paola; Lai, Zhihong Vicki

2011-01-01

Research and development activities in an era of globalization encounter a mosaic of providers, products, services, and intermediaries; regulatory and other government institutions; and consumers. The introduction of novel therapeutics into this environment mandates research programs that are relevant to the registration process, payers and purchasers, transparent pricing, and rule-driven business practices, while providing data relevant to marketing initiatives internationally. To outline an example for clinical development programs that incorporate the perspective of multiple stakeholders into a portfolio of study designs to provide optimal data platforms that can resonate with diverse recipients. A contract research organization directly involved in the design, execution, and analysis of clinical trials for new drugs and devices across pharmaceutical and biotechnology companies provides a unique perspective regarding opportunities and challenges within the international clinical research environment. Drs Murphy, Antonini, and Lai, representing Worldwide Clinical Trials, utilize chronic obstructive pulmonary disease as a demonstration project exploiting its prevalence, direct and indirect costs, and the rapid infusion/diffusion of innovative therapy into practice as a rationale for focus, and illustrate methods of informing registration and technology assessments during a prototypical development process. By virtue of its chronicity, prevalence, and pattern of healthcare utilization, chronic obstructive pulmonary disease provides an ideal case for illustrating the application of clinical trial methodology that can facilitate data evaluation through the prism of multiple stakeholders. Adding an international dimension exacerbates system complexity and serves to illustrate the breadth of issues that can be addressed within this therapeutic area.

Clinical proteomic biomarkers: relevant issues on study design & technical considerations in biomarker development

PubMed Central

2014-01-01

Biomarker research is continuously expanding in the field of clinical proteomics. A combination of different proteomic–based methodologies can be applied depending on the specific clinical context of use. Moreover, current advancements in proteomic analytical platforms are leading to an expansion of biomarker candidates that can be identified. Specifically, mass spectrometric techniques could provide highly valuable tools for biomarker research. Ideally, these advances could provide with biomarkers that are clinically applicable for disease diagnosis and/ or prognosis. Unfortunately, in general the biomarker candidates fail to be implemented in clinical decision making. To improve on this current situation, a well-defined study design has to be established driven by a clear clinical need, while several checkpoints between the different phases of discovery, verification and validation have to be passed in order to increase the probability of establishing valid biomarkers. In this review, we summarize the technical proteomic platforms that are available along the different stages in the biomarker discovery pipeline, exemplified by clinical applications in the field of bladder cancer biomarker research. PMID:24679154

Cell-based interventions for neurologic conditions: ethical challenges for early human trials.

PubMed

Mathews, D J H; Sugarman, J; Bok, H; Blass, D M; Coyle, J T; Duggan, P; Finkel, J; Greely, H T; Hillis, A; Hoke, A; Johnson, R; Johnston, M; Kahn, J; Kerr, D; Kurtzberg, J; Liao, S M; McDonald, J W; McKhann, G; Nelson, K B; Rao, M; Regenberg, A; Siegel, A W; Smith, K; Solter, D; Song, H; Vescovi, A; Young, W; Gearhart, J D; Faden, R

2008-07-22

Attempts to translate basic stem cell research into treatments for neurologic diseases and injury are well under way. With a clinical trial for one such treatment approved and in progress in the United States, and additional proposals under review, we must begin to address the ethical issues raised by such early forays into human clinical trials for cell-based interventions for neurologic conditions. An interdisciplinary working group composed of experts in neuroscience, cell biology, bioethics, law, and transplantation, along with leading disease researchers, was convened twice over 2 years to identify and deliberate on the scientific and ethical issues raised by the transition from preclinical to clinical research of cell-based interventions for neurologic conditions. While the relevant ethical issues are in many respects standard challenges of human subjects research, they are heightened in complexity by the novelty of the science, the focus on the CNS, and the political climate in which the science is proceeding. Distinctive challenges confronting US scientists, administrators, institutional review boards, stem cell research oversight committees, and others who will need to make decisions about work involving stem cells and their derivatives and evaluate the ethics of early human trials include evaluating the risks, safety, and benefits of these trials, determining and evaluating cell line provenance, and determining inclusion criteria, informed consent, and the ethics of conducting early human trials in the public spotlight. Further study and deliberation by stakeholders is required to move toward professional and institutional policies and practices governing this research.

When snakes bite: the management of North American Crotalinae snake envenomation.

PubMed

Ashton, Jenny; Baker, Stephanie N; Weant, Kyle A

2011-01-01

There are more than 120 species of snakes indigenous to the United States, 25 of which are venomous. Although snake envenomation carries a relatively low risk of mortality in the United States, it can result in significant morbidity if left untreated. The venom of Crotalinae snakes contains a complex mixture of enzymatic proteins with various clinical implications. Of these complications, the most significant are consumptive coagulopathy, compartment syndrome, and hypovolemic shock. The development of ovine Crotalidae polyvalent immune Fab antivenin (CroFab) has greatly changed the approach to snake envenomation. Nevertheless, multiple factors complicate its use and the overall management of this clinical presentation. The intent of this review is to discuss relevant management issues associated with Crotalinae envenomation in the emergency department.

Financial toxicity in cancer care.

PubMed

O'Connor, Jeremy M; Kircher, Sheetal M; de Souza, Jonas A

2016-03-01

The cost of cancer care is increasing, with important implications for the delivery of high-quality, patent-centered care. In the clinical setting, patents and physicians express a desire to discuss out-of-pocket costs. Nevertheless, both groups feel inadequately prepared to participate in these discussions, and perhaps not surprisingly, the integration of these discussions into clinical practice seems to be the exception rather than the rule. The resulting neglect of financial issues has the potential to cause unnecessary suffering for oncology patents. In this paper, we review the most relevant literature on financial toxicity in cancer care. In addition, we discuss potential predictors of financial toxicity, and the recent development of instruments to help clinicians and researchers quantify financial burden. ©2016 Frontline Medical Communications.

Theory of mind, social development, and psychosis.

PubMed

Casacchia, Massimo; Mazza, Monica; Roncone, Rita

2004-06-01

The difficulty in interpreting other people's mental states found in children with autism and in people affected by schizophrenia may be explained in terms of a unique mental process called Theory of Mind. The paper discusses the main operational issues of such a peculiar aspect of social cognition, the Theory of Mind, and its implication in schizophrenia, including a review of its related neural structures. Theory of Mind abilities may be a relevant aspect of social interaction involving people affected by schizophrenia, and they need to be further investigated in clinical research.

Biliary pain--work-up and management in general practice.

PubMed

Crawford, Michael

2013-07-01

Pain arising from the gallbladder and biliary tree is a common clinical presentation. Differentiation from other causes of abdominal pain can sometimes be difficult. This article discusses the work-up, management and after care of patients with biliary pain. The role for surgery for gallstones and gallbladder polyps is described. Difficulties in the diagnosis and management of gallbladder pain are discussed. Intra- and post-operative complications are described, along with their management. The issue of post-operative pain in particular is examined, focusing on the timing of the pain and the relevant investigations.

Reflections on practitioner-researcher collaborative inquiry.

PubMed

Stockton, Rex; Morran, Keith

2010-04-01

We offer comments regarding two articles in this issue, one titled "Bridging the Practitioner-Scientist Gap in Group Psychotherapy Research" and a complementary article providing the results of a survey, entitled "A Survey of Canadian Group Psychotherapist Association Members' Perceptions of Psychotherapy Research." We also make several recommendations for collaborative research between practitioners and scientists, such as the inclusion of clinicians on the research team, practice research networks, and improved approaches to communicating clinically relevant research findings. Also discussed are reflections and recommendations from the authors' experience as scientist-practitioners.

A pathophysiologic approach to growth problems in children with attention-deficit/hyperactivity disorder.

PubMed

Tenore, Alfred; Tenore, Andrew

2012-12-01

In recent years there has been an increasing trend in the diagnosis and treatment of children with attention-deficit/hyperactivity disorder (ADHD) worldwide. One of the most frequently discussed side effects of these treatments is related to problems of growth. In order to better understand what ADHD is and the mechanisms by which it could affect growth, this article reviews relevant data from a clinical and neurophysiologic perspective to improve understanding of this controversial issue. Copyright © 2012 Elsevier Inc. All rights reserved.

[Materiality Analysis of Health Plans Based on Stakeholder Engagement and the Issues Included at ISO 26000:2010].

PubMed

Moyano Santiago, Miguel Angel; Rivera Lirio, Juana María

2017-01-18

Health plans of the Spanish autonomous communities can incorporate sustainable development criteria in its development. There have been no analysis or proposals about development and indicators. The goal is to add a contribution to help build better health plans aimed at sustainable development and help to manage economic, social and environmental impacts of health systems criteria. We used a variation of the RAND/UCLA or modified Delphi technique method. The process consisted of a bibliographical and context matters and issues related to health and social responsibility analysis based on ISO 26000: 2010. A survey by deliberately to a selection of 70 expert members of the identified stakeholders was carried out and a discussion group was held to determine the consensus on the issues addressed in the survey sample. The research was conducted in 2015. From the literature review 33 health issues included in ISO 26000:2010 were obtained. 7 survey proved relevant high consensus, 8 relevance and average consensus and 18 with less relevance and high level of dissent. The expert group excluded 4 of the 18 subjects with less consensus. 29 issues included 33 at work, divided into 7 subjects contained in the guide ISO 26000 of social responsibility, were relevant stakeholders regarding possible inclusion in health plans. Considering the direct relationship published by ISO (International Organization for Standardization) among the issues ISO 26000 and the economic, social and environmental indicators in GRI (Global Reporting Initiative) in its G4 version, a panel with monitoring indicators related to relevant issues were elaborated.

Towards pervasive computing in health care - a literature review.

PubMed

Orwat, Carsten; Graefe, Andreas; Faulwasser, Timm

2008-06-19

The evolving concepts of pervasive computing, ubiquitous computing and ambient intelligence are increasingly influencing health care and medicine. Summarizing published research, this literature review provides an overview of recent developments and implementations of pervasive computing systems in health care. It also highlights some of the experiences reported in deployment processes. There is no clear definition of pervasive computing in the current literature. Thus specific inclusion criteria for selecting articles about relevant systems were developed. Searches were conducted in four scientific databases alongside manual journal searches for the period of 2002 to 2006. Articles included present prototypes, case studies and pilot studies, clinical trials and systems that are already in routine use. The searches identified 69 articles describing 67 different systems. In a quantitative analysis, these systems were categorized into project status, health care settings, user groups, improvement aims, and systems features (i.e., component types, data gathering, data transmission, systems functions). The focus is on the types of systems implemented, their frequency of occurrence and their characteristics. Qualitative analyses were performed of deployment issues, such as organizational and personnel issues, privacy and security issues, and financial issues. This paper provides a comprehensive access to the literature of the emerging field by addressing specific topics of application settings, systems features, and deployment experiences. Both an overview and an analysis of the literature on a broad and heterogeneous range of systems are provided. Most systems are described in their prototype stages. Deployment issues, such as implications on organization or personnel, privacy concerns, or financial issues are mentioned rarely, though their solution is regarded as decisive in transferring promising systems to a stage of regular operation. There is a need for further research on the deployment of pervasive computing systems, including clinical studies, economic and social analyses, user studies, etc.

Some controversial multiple testing problems in regulatory applications.

PubMed

Hung, H M James; Wang, Sue-Jane

2009-01-01

Multiple testing problems in regulatory applications are often more challenging than the problems of handling a set of mathematical symbols representing multiple null hypotheses under testing. In the union-intersection setting, it is important to define a family of null hypotheses relevant to the clinical questions at issue. The distinction between primary endpoint and secondary endpoint needs to be considered properly in different clinical applications. Without proper consideration, the widely used sequential gate keeping strategies often impose too many logical restrictions to make sense, particularly to deal with the problem of testing multiple doses and multiple endpoints, the problem of testing a composite endpoint and its component endpoints, and the problem of testing superiority and noninferiority in the presence of multiple endpoints. Partitioning the null hypotheses involved in closed testing into clinical relevant orderings or sets can be a viable alternative to resolving the illogical problems requiring more attention from clinical trialists in defining the clinical hypotheses or clinical question(s) at the design stage. In the intersection-union setting there is little room for alleviating the stringency of the requirement that each endpoint must meet the same intended alpha level, unless the parameter space under the null hypothesis can be substantially restricted. Such restriction often requires insurmountable justification and usually cannot be supported by the internal data. Thus, a possible remedial approach to alleviate the possible conservatism as a result of this requirement is a group-sequential design strategy that starts with a conservative sample size planning and then utilizes an alpha spending function to possibly reach the conclusion early.

Targeting targeted agents: open issues for clinical trial design.

PubMed

Bria, Emilio; Di Maio, Massimo; Carlini, Paolo; Cuppone, Federica; Giannarelli, Diana; Cognetti, Francesco; Milella, Michele

2009-05-22

Molecularly targeted agents for the treatment of solid tumors had entered the market in the last 5 years, with a great impact upon both the scientific community and the society. Many randomized phase III trials conducted in recent years with new targeted agents, despite previous data coming from preclinical research and from phase II trials were often promising, have produced disappointingly negative results. Some other trials have actually met their primary endpoint, demonstrating a statistically significant result favouring the experimental treatment. Unfortunately, with a few relevant exceptions, this advantage is often small, if not negligible, in absolute terms. The difference between statistical significance and clinical relevance should always be considered when translating clinical trials' results in the practice. The reason why this 'revolution' did not significantly impact on cancer treatment to displace chemotherapy from the patient' bedside is in part due to complicated, and in many cases, unknown, mechanisms of action of such drugs; indeed, the traditional way the clinical investigators were used to test the efficacy of 'older' chemotherapeutics, has become 'out of date' from the methodological perspective. As these drugs should be theoretically tailored upon featured bio-markers expressed by the patients, the clinical trial design should follow new rules based upon stronger hypotheses than those developed so far. Indeed, the early phases of basic and clinical drug development are crucial in the correct process which is able to correctly identify the target (when present). Targeted trial designs can result in easier studies, with less, better selected, and supported by stronger proofs of response evidences, patients, in order to not waste time and resources.

Exploring policy makers' perspectives on a clinical controversy: airway surgery for adult obstructive sleep apnoea.

PubMed

Elshaug, A G; Hiller, J E; Moss, J R

2009-10-01

Worldwide, there is increasing focus on measures to reduce ineffective healthcare practices. Upper airway surgeries for the treatment of adult obstructive sleep apnoea (OSA) represent a case-study in this area, given recent publications that draw into question their efficacy. Policy stakeholders were canvassed to assess their perspectives on this. Senior health policy stakeholders from Australia were criterion and snowball sampled (to identify opinion leaders). Participants were presented with preparatory material and took part in individual semistructured interviews. These focused on eliciting responses to recently published evidence and a relevant Cochrane review. Questions were posed relating to clinical effectiveness and associated policy implications. Interviews were taped and transcribed for thematic analysis. Participant comments were de-identified. Ten stakeholders were interviewed before saturation was reached. Thematic analysis highlighted participant concern with the diversity of procedures on offer, coupled with limited effectiveness (suggesting potential clinical uncertainty) and considerations therefore of resource allocation (potential opportunity cost). Stakeholders seem aware of the methodological complexities, the ethical issues raised and the role of patients in considerations regarding appropriateness. Finally, policy stakeholders acknowledge that these procedures appear appropriate only for a minority, with consensus that policy level restrictions to government funding for these procedures may be warranted. This report highlights that this clinical controversy is of interest and relevance from a policy perspective with lessons and potential implications for clinical practice. It further highlights the need for clinical consensus on definitions of surgical "success" in treating this condition, as this forms an important pretext to policy considerations.

Impact of parental acquired brain injury on children: Review of the literature and conceptual model.

PubMed

Tiar, Anna Maria Vitale; Dumas, Jean E

2015-01-01

Data on children's adjustment following parental acquired brain injury (ABI) are disparate and spare, and appear inconclusive. Nonetheless, they suggest that children's well-being is at risk, but often neglected. Indeed, lack of a unifying conceptual model makes it difficult to integrate available evidence, in order to circumscribe relevant factors and understand how these may influence children's outcomes in more or less favourable ways. The present review proposes the coping competence model as a theoretical framework apt to clarify these issues and organize the available evidence. In brief, the model states that impact of parental ABI on children reflects the extent of the challenges children face and their preponderant ways of coping with them, i.e. pro-socially, anti-socially or asocially. Evidence shows that children deal with some common socioaffective as well as achievement challenges. Further, it is consistent with the three main coping modalities supported by the model. Overall, children's outcomes appear variable, but clearly at risk and in need of special attention. This review summarizes these outcomes, raises conceptual as well as methodological questions to be addressed in future research and eventually presents relevant issues for support and clinical services.

Publications in anesthesia journals: quality and clinical relevance.

PubMed

Lauritsen, Jakob; Moller, Ann M

2004-11-01

Clinicians performing evidence-based anesthesia rely on anesthesia journals for clinically relevant information. The objective of this study was to analyze the proportion of clinically relevant articles in five high impact anesthesia journals. We evaluated all articles published in Anesthesiology, Anesthesia & Analgesia, British Journal of Anesthesia, Anesthesia, and Acta Anaesthesiologica Scandinavica from January to June, 2000. Articles were assessed and classified according to type, outcome, and design; 1379 articles consisting of 5468 pages were evaluated and categorized. The most common types of article were animal and laboratory research (31.2%) and randomized clinical trial (20.4%). A clinically relevant article was defined as an article that used a statistically valid method and had a clinically relevant end-point. Altogether 18.6% of the pages had as their subject matter clinically relevant trials. We compared the Journal Impact Factor (a measure of the number of citations per article in a journal) and the proportion of clinically relevant pages and found that they were inversely proportional to each other.

Laboratory diagnosis of Ebola virus disease and corresponding biosafety considerations in the China Ebola Treatment Center.

PubMed

Huang, Qing; Fu, Wei-Ling; You, Jian-Ping; Mao, Qing

2016-10-01

Ebola virus disease (EVD), caused by Ebola virus (EBOV), is a potent acute infectious disease with a high case-fatality rate. Etiological and serological EBOV detection methods, including techniques that involve the detection of the viral genome, virus-specific antigens and anti-virus antibodies, are standard laboratory diagnostic tests that facilitate confirmation or exclusion of EBOV infection. In addition, routine blood tests, liver and kidney function tests, electrolytes and coagulation tests and other diagnostic examinations are important for the clinical diagnosis and treatment of EVD. Because of the viral load in body fluids and secretions from EVD patients, all body fluids are highly contagious. As a result, biosafety control measures during the collection, transport and testing of clinical specimens obtained from individuals scheduled to undergo EBOV infection testing (including suspected, probable and confirmed cases) are crucial. This report has been generated following extensive work experience in the China Ebola Treatment Center (ETC) in Liberia and incorporates important information pertaining to relevant diagnostic standards, clinical significance, operational procedures, safety controls and other issues related to laboratory testing of EVD. Relevant opinions and suggestions are presented in this report to provide contextual awareness associated with the development of standards and/or guidelines related to EVD laboratory testing.

Treating impaired cognition in schizophrenia: the case for combining cognitive-enhancing drugs with cognitive remediation.

PubMed

Michalopoulou, Panayiota G; Lewis, Shôn W; Wykes, Til; Jaeger, Judith; Kapur, Shitij

2013-08-01

Cognitive impairment is a well-documented feature of schizophrenia and represents a major impediment to the functional recovery of patients. The therapeutic strategies to improve cognition in schizophrenia have either used medications (collectively referred to as 'cognitive-enhancing drugs' in this article) or non-pharmacological training approaches ('cognitive remediation'). Cognitive-enhancing drugs have not as yet been successful and cognitive remediation has shown modest success. Therefore, we may need to explore new therapeutic paradigms to improve cognition in schizophrenia. The optimal approach may require a combination of cognitive-enhancing drugs with cognitive remediation. We review the available data from animal and human studies that provide the conceptual basis, proof-of-concept and illustrations of success of such combination strategies in experimental and clinical paradigms in other conditions. We address the major design issues relevant to the choice of the cognitive-enhancing drugs and cognitive remediation, as well as the timing and the duration of the intervention as will be relevant for schizophrenia. Finally, we address the practical realities of the development and testing of such combined approaches in the real-world clinical situation and conclude that while scientifically attractive, there are several practical difficulties to be overcome for this approach to be clinically feasible. Copyright © 2013 Elsevier B.V. and ECNP. All rights reserved.

Enhancing the supportive care of parents with advanced cancer: development of a self-directed educational manual.

PubMed

Turner, Jane; Clavarino, Alexandra; Yates, Patsy; Hargraves, Maryanne; Connors, Veronica; Hausmann, Sue

2008-08-01

Diagnosing and treating young patients with cancer can be stressful for health professionals; however, when the prognosis is poor and the patient has dependent children, even experienced clinicians can feel distressed and helpless. Parents with advanced cancer commonly express anxiety about the impact of the disease on their children, yet health professionals often feel unable to respond constructively because of lack of training, or concern that discussion about such difficult issues will compound parental distress. In response to this problem, an educational manual has been devised to assist oncology staff to better understand the emotional impact of parental advanced cancer, encompassing information about specific reactions of children, including strategies to help children and families cope. This paper describes the development and content of the resource which provides clinically relevant information and evidence-based recommendations to guide supportive care. The manual differs from the more traditional didactic resources in that it examines the very personal impact for professionals working with parents with advanced disease, encouraging reflection and engages the reader in clinical exercises which encourage active learning and application of knowledge into authentic clinical contexts. Although the manual is designed primarily for nurses, it is clear that much of the information is relevant for all health professionals involved in the care of parents with advanced cancer.

The Australian model of immunization advice and vaccine funding.

PubMed

Nolan, Terry M

2010-04-19

The Australian Government has implemented new arrangements for public funding of vaccines over the past 5 years. By utilising the standard Pharmaceutical Benefits Advisory Committee (PBAC) application process, whether for funding under the National Immunisation Program Schedule (NIP) or under the Pharmaceutical Benefits Scheme (PBS), a predictable and transparent process for vaccine funding recommendations has been established. This process uses the high-level technical resources available through the Australian Technical Advisory Group on Immunisation (ATAGI) to ensure that both vaccine manufacturers and the PBAC are optimally informed about all relevant aspects of population benefits and delivery of vaccines. ATAGI has a long-standing and mutually beneficial dialogue with State and Territory Governments, providers, and vaccine manufacturers to ensure that pipeline awareness, supply issues, and all relevant scientific and clinical details are well understood. Copyright © 2010 Elsevier Ltd. All rights reserved.

Ethics of the electrified mind: Defining issues and perspectives on the principled use of brain stimulation in medical research and clinical care

PubMed Central

Cabrera, Laura Y.; Evans, Emily L.; Hamilton, Roy H.

2013-01-01

In recent years, non-pharmacologic approaches to modifying human neural activity have gained increasing attention. One of these approaches is brain stimulation, which involves either the direct application of electrical current to structures in the nervous system or the indirect application of current by means of electromagnetic induction. Interventions that manipulate the brain have generally been regarded as having both the potential to alleviate devastating brain-related conditions and the capacity to create unforeseen and unwanted consequences. Hence, although brain stimulation techniques offer considerable benefits to society, they also raise a number of ethical concerns. In this paper we will address various dilemmas related to brain stimulation in the context of clinical practice and biomedical research. We will survey current work involving deep brain stimulation (DBS), transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). We will reflect upon relevant similarities and differences between them, and consider some potentially problematic issues that may arise within the framework of established principles of medical ethics: nonmaleficence and beneficence, autonomy, and justice. PMID:23733209

Ambiguous genitalia in the newborn: an overview and teaching tool.

PubMed

Murphy, Carla; Allen, L; Jamieson, Mary Anne

2011-10-01

Ambiguous genitalia is a significant example of a disorder of sexual development, in which the external genitalia do not have the typical appearance of either sex. Although the birth of a child with ambiguous genitalia is rare, the emergent nature of the issue demands that healthcare providers have at least a familiarity with the underlying etiologies, the issues, and the initial approach to diagnosis and management. With numerous etiologies, potential difficulties with reaching a diagnosis, and many challenges with immediate and long-term care, the topic of ambiguous genitalia can be daunting. We provide a review of basic embryology, as well as a classification system for understanding the various etiological causes of ambiguous genitalia. The important clinical aspects of diagnosis and management are also highlighted, and a teaching tool has been included to help the reader (or their learners) to solidify information presented. Our overall goal is to provide practical information on ambiguous genitalia and allow the clinician to apply this information to clinically relevant scenarios. Copyright © 2011 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Infections are a global issue: infection addresses global issues.

PubMed

Grobusch, M P; Calleri, G; Bogner, J R

2012-12-01

Infections are of unifying global concern, despite regional differences in disease epidemiology, clinical appearance and the instruments to tackle them. The primary aim of Infection is "to be a forum for the presentation and discussion of clinically relevant information on infectious diseases… from all over the world". To that end, and as a reflection of the global burden of infectious diseases, we intend to increase the number of high-quality contributions from authors addressing the aetiology, pathogenesis, diagnosis and treatment of infectious diseases from outside Europe and the affluent North (Chang et al. Infection 40:359-365, 2012; Misra et al. Infection 40:125-130, 2012). The Editorial Board of Infection envisages the journal as an interface between where infectious diseases meet and mix between "North and South"--i.e., the field of travel medicine--frequently functioning as a sentinel for altered/novel disease activities that are encountered as imported conditions. With the change in generation on the Editorial Board, Infection aims to expand the areas of tropical medicine, travel medicine and global health with its own section editors (GC and MPG). Contributions from outside Europe are actively encouraged.

Patient-Reported Outcomes Are Changing the Landscape in Oncology Care: Challenges and Opportunities for Payers

PubMed Central

Zagadailov, Erin; Fine, Michael; Shields, Alan

2013-01-01

Background A patient-reported outcome (PRO) is a subjective report that comes from a patient without interpretation by a clinician. Because of the increasingly significant role of PROs in the development and evaluation of new medicines, the US Food and Drug Administration (FDA) issued a formal guidance to describe how PRO instruments will be reviewed and evaluated with respect to claims in approved medical product labeling. Meanwhile, PROs continue to appear in oncology clinical trials more frequently; however, it is unclear how payers and policymakers can use PRO data in the context of decision-making for cancer treatments. Objective The objective of this article is to discuss the challenges and opportunities of incorporating oncology-related PRO data into payer decision-making. Discussion Payer concerns with PRO instruments are often related to issues regarding measurement, relevance, quality, and interpretability of PROs. Payers may dismiss PROs that do not independently predict improved outcomes. The FDA guidance released in 2009 demonstrates, as evidenced by the case of ruxolitinib, how PRO questionnaires can be generated in a relevant, trustworthy, and meaningful way, which provides an opportunity for payers and policy decision makers to focus on how to use PRO data in their decision-making. This is particularly relevant in oncology, where a recent and sizable number of clinical trials include PRO measures. Conclusion As an increasing number of oncology medications enter the market with product labeling claims that contain PRO data, payers will need to better familiarize themselves with the opportunities associated with PRO questionnaires when making coverage decisions. PRO measures will continue to provide valuable information regarding the risk–benefit profile of novel agents. As such, PRO measures may provide evidence that should be considered in payers' decisions and discussions; however, the formal role of PROs and the pertinence of PROs in decision-making has yet to be understood. PMID:24991362

Seeing more clearly through the fog of encephalopathy.

PubMed

Kaplan, Peter W; Sutter, Raoul

2013-10-01

Patients with acute confusional states (often referred to as encephalopathy or delirium) pose diagnostic and management challenges for treating physicians. Encephalopathy is associated with a high morbidity and mortality rate, and the diagnosis rests on clinical grounds but may also be supported by the finding of electroencephalographic (EEG) evidence for diffuse cerebral dysfunction. The myriad cerebral transmitter and metabolic disruptions are generated by systemic organ system failures, principal among which are those of the liver, kidneys, lungs, heart, and endocrine system, along with the effects of exogenous toxins and medications. In most cases, several of these organ failures together contribute to the confusional state, frequently in the context of a diffuse cerebral atrophy that affects the aging brain. This special issue of the Journal of Clinical Neurophysiology is dedicated to exploring the electrophysiology of these conditions. It reviews the pathophysiology, psychiatric manifestations, clinical and imaging correlations of the many causes and types of encephalopathy. A literature review of the EEG abnormalities in the various types of encephalopathy provides an overview that ranges from paraneoplastic causes, through organ system failures, postcardiorespiratory arrest, to postoperative delirium. The issue is supplemented by tables of relevant clinical correlations, graphs, Venn diagrams, and the use of mathematical modeling used to explain how defects in the neuronal interplay might generate the EEG patterns seen in encephalopathy. We hope that this assembly will act as a springboard for further discussion and investigation into the EEG underpinnings, clinical correlations, diagnosis. and prognostication of these common and morbid disturbances of brain function.

Deciding about fast and slow decisions.

PubMed

Croskerry, Pat; Petrie, David A; Reilly, James B; Tait, Gordon

2014-02-01

Two reports in this issue address the important topic of clinical decision making. Dual process theory has emerged as the dominant model for understanding the complex processes that underlie human decision making. This theory distinguishes between the reflexive, autonomous processes that characterize intuitive decision making and the deliberate reasoning of an analytical approach. In this commentary, the authors address the polarization of viewpoints that has developed around the relative merits of the two systems. Although intuitive processes are typically fast and analytical processes slow, speed alone does not distinguish them. In any event, the majority of decisions in clinical medicine are not dependent on very short response times. What does appear relevant to diagnostic ease and accuracy is the degree to which the symptoms of the disease being diagnosed are characteristic ones. There are also concerns around some methodological issues related to research design in this area of enquiry. Reductionist approaches that attempt to isolate dependent variables may create such artificial experimental conditions that both external and ecological validity are sacrificed. Clinical decision making is a complex process with many independent (and interdependent) variables that need to be separated out in a discrete fashion and then reflected on in real time to preserve the fidelity of clinical practice. With these caveats in mind, the authors believe that research in this area should promote a better understanding of clinical practice and teaching by focusing less on the deficiencies of intuitive and analytical systems and more on their adaptive strengths.

SIAMOC position paper on gait analysis in clinical practice: General requirements, methods and appropriateness. Results of an Italian consensus conference.

PubMed

Benedetti, Maria Grazia; Beghi, Ettore; De Tanti, Antonio; Cappozzo, Aurelio; Basaglia, Nino; Cutti, Andrea Giovanni; Cereatti, Andrea; Stagni, Rita; Verdini, Federica; Manca, Mario; Fantozzi, Silvia; Mazzà, Claudia; Camomilla, Valentina; Campanini, Isabella; Castagna, Anna; Cavazzuti, Lorenzo; Del Maestro, Martina; Croce, Ugo Della; Gasperi, Marco; Leo, Tommaso; Marchi, Pia; Petrarca, Maurizio; Piccinini, Luigi; Rabuffetti, Marco; Ravaschio, Andrea; Sawacha, Zimi; Spolaor, Fabiola; Tesio, Luigi; Vannozzi, Giuseppe; Visintin, Isabella; Ferrarin, Maurizio

2017-10-01

Gait analysis is recognized as a useful assessment tool in the field of human movement research. However, doubts remain on its real effectiveness as a clinical tool, i.e. on its capability to change the diagnostic-therapeutic practice. In particular, the conditions in which evidence of a favorable cost-benefit ratio is found and the methodology for properly conducting and interpreting the exam are not identified clearly. To provide guidelines for the use of Gait Analysis in the context of rehabilitation medicine, SIAMOC (the Italian Society of Clinical Movement Analysis) promoted a National Consensus Conference which was held in Bologna on September 14th, 2013. The resulting recommendations were the result of a three-stage process entailing i) the preparation of working documents on specific open issues, ii) the holding of the consensus meeting, and iii) the drafting of consensus statements by an external Jury. The statements were formulated based on scientific evidence or experts' opinion, when the quality/quantity of the relevant literature was deemed insufficient. The aim of this work is to disseminate the consensus statements. These are divided into 13 questions grouped in three areas of interest: 1) General requirements and management, 2) Methodological and instrumental issues, and 3) Scientific evidence and clinical appropriateness. SIAMOC hopes that this document will contribute to improve clinical practice and help promoting further research in the field. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Understanding the Research–Policy Divide for Oral Health Inequality

PubMed Central

Bell, Erica; Crocombe, Leonard; Campbell, Steven; Goldberg, Lynette R.; Seidel, Bastian M.

2014-01-01

Background: No studies exist of the congruence of research in oral health to policy. This study aimed to examine the broad congruence of oral health research to policy, and implications for developing oral health research that is more policy relevant, particularly for the wider challenge of addressing unequal oral health outcomes, rather than specific policy translation issues. Methods: Bayesian-based software was used in a multi-layered method to compare the conceptual content of 127,193 oral health research abstracts published between 2000–2012 with eight current oral health policy documents from Organisation for Economic Co-operation and Development countries. Findings: Fifty-five concepts defined the research abstracts, of which only eight were policy-relevant, and six of which were minor research concepts. Conclusions The degree of disconnection between clinical concepts and healthcare system and workforce development concepts was striking. This study shows that, far from being “lost in translation,” oral health research and policy are so different as to raise doubts about the extent to which research is policy-relevant and policy is research-based. The notion of policy relevance encompasses the lack of willingness of policy makers to embrace research, and the need for researchers to develop research that is, and is seen to be, policy-relevant. PMID:25617516

Stakeholder views on returning research results.

PubMed

Haga, Susanne B; Zhao, Jennifer Q

2013-01-01

While the disclosure of research findings is relevant to all types of biomedical research, it has garnered particular attention with respect to genetics and genomics research due to some of the unique aspects of the data and the high public profile of the field. In this chapter, we review the attitudes of stakeholders (research participants, policymakers, and researchers) to define areas of consensus regarding the issue of returning research results across and within groups. In addition to stakeholder attitudes about obligations and interest in research results, other major related issues related to returning research results, such as informed consent, communication of research results, and cost, are discussed. Given the consensus between stakeholders to return summary reports of a study's outcomes and individual research results of clinical significance, we conclude that the time has come to encourage, if not require, researchers to consider these issues in the developmental planning stages of a project and to plan and budget accordingly. © 2013 Elsevier Inc. All rights reserved.

European consensus conference on faecal microbiota transplantation in clinical practice.

PubMed

Cammarota, Giovanni; Ianiro, Gianluca; Tilg, Herbert; Rajilić-Stojanović, Mirjana; Kump, Patrizia; Satokari, Reetta; Sokol, Harry; Arkkila, Perttu; Pintus, Cristina; Hart, Ailsa; Segal, Jonathan; Aloi, Marina; Masucci, Luca; Molinaro, Antonio; Scaldaferri, Franco; Gasbarrini, Giovanni; Lopez-Sanroman, Antonio; Link, Alexander; de Groot, Pieter; de Vos, Willem M; Högenauer, Christoph; Malfertheiner, Peter; Mattila, Eero; Milosavljević, Tomica; Nieuwdorp, Max; Sanguinetti, Maurizio; Simren, Magnus; Gasbarrini, Antonio

2017-04-01

Faecal microbiota transplantation (FMT) is an important therapeutic option for Clostridium difficile infection. Promising findings suggest that FMT may play a role also in the management of other disorders associated with the alteration of gut microbiota. Although the health community is assessing FMT with renewed interest and patients are becoming more aware, there are technical and logistical issues in establishing such a non-standardised treatment into the clinical practice with safety and proper governance. In view of this, an evidence-based recommendation is needed to drive the practical implementation of FMT. In this European Consensus Conference, 28 experts from 10 countries collaborated, in separate working groups and through an evidence-based process, to provide statements on the following key issues: FMT indications; donor selection; preparation of faecal material; clinical management and faecal delivery and basic requirements for implementing an FMT centre. Statements developed by each working group were evaluated and voted by all members, first through an electronic Delphi process, and then in a plenary consensus conference. The recommendations were released according to best available evidence, in order to act as guidance for physicians who plan to implement FMT, aiming at supporting the broad availability of the procedure, discussing other issues relevant to FMT and promoting future clinical research in the area of gut microbiota manipulation. This consensus report strongly recommends the implementation of FMT centres for the treatment of C. difficile infection as well as traces the guidelines of technicality, regulatory, administrative and laboratory requirements. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Cultural competency: providing quality care to diverse populations.

PubMed

Betancourt, Joseph R

2006-12-01

The goal of this paper is to define cultural competence and present a practical framework to address crosscultural challenges that emerge in the clinical encounter, with a particular focus on the issue of nonadherence. English-language literature, both primary and reports from various agencies, and the author's personal experiences in clinical practice. Relevant literature on patient-centered care and cultural competence. There is a growing literature that delineates the impact of sociocultural factors, race, ethnicity, and limited-English proficiency on health and clinical care. The field of cultural competence focuses on addressing these issues. Health care providers need a practical set of tools and skills that will enable them to provide quality care to patients during a brief encounter, whatever differences in background that may exist. Cultural competence has evolved from the gathering of information and making of assumptions about patients on the basis of their sociocultural background to the development of skills to implement the principles of patient-centered care. This patient-based approach to cross-cultural care consists of first, assessing core cross-cultural issues; second, exploring the meaning of the illness to the patient; third, determining the social context in which the patient lives; and fourth, engaging in negotiation with the patient to encourage adherence. Addressing adherence is a particularly challenging issue, the determinants of which are multifactorial, and the ESFT (explanatory/social/fears/treatment) model--derived from the patient-based approach--is a tool that identifies barriers to adherence and provides strategies to address them. It obviously is impossible to learn everything about every culture and that should not be expected. Instead, we should learn about the communities we care for. More important, we should have a framework that allows us to provide appropriate care for any patient--one that deals with issues of adherence--regardless of the patient's race, ethnicity, or cultural background.

Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care

PubMed Central

Fredericksen, RJ; Tufano, J; Ralston, J; McReynolds, J; Stewart, M; Lober, WB; Mayer, K; Mathews, WC; Mugavero, M; Crane, PK; Crane, HM

2016-01-01

Strong evidence suggests that patient-reported outcomes (PROs) aid in managing chronic conditions, reduce omissions in care, and improve patient-provider communication. However, provider acceptability of PROs and their use in clinical HIV care is not well known. We interviewed providers (n=27) from four geographically diverse HIV and community care clinics in the U.S. that have integrated PROs into routine HIV care, querying perceived value, challenges, and use of PRO data. Perceived benefits included the ability of PROs to identify less-observable behaviors and conditions, particularly suicidal ideation, depression, and substance use; usefulness in agenda-setting prior to a visit; and reduction of social desirability bias in patient-provider communication. Challenges included initial flow integration issues and ease of interpretation of PRO feedback. Providers value same-day, electronic patient-reported measures for use in clinical HIV care with the condition that PROs are 1) tailored to be the most clinically relevant to their population; 2) well-integrated into clinic flow; 3) easy to interpret, highlighting chief patient concerns and changes over time. PMID:27237187

Outpatient nursing clinic for congenital heart disease patients: Copenhagen Transition Program.

PubMed

Berg, Selina Kikkenborg; Hertz, Pernille Grarup

2007-01-01

Adolescents with congenital heart disease need support transitioning from childhood to adulthood. To become independent, adolescents need to possess knowledge about the disease and how to handle life with congenital heart disease. Outpatient nursing clinics can address issues relevant for adolescents. Creating an environment in which worries and questions can be discussed better prepares adolescents to meet the struggles of living with congenital heart disease. The Copenhagen Transition Program was established in 2004. This outpatient nursing clinic was established by (1) defining the target group, (2) conducting a literature review, (3) collaborating with interdisciplinary colleagues, (4) scheduling visits to the transition-nursing clinic, (5) arranging clinic visits, (6) charting, and (7) testing and evaluating the clinic. Adolescents with congenital heart disease are invited to a consultation with a specially trained nurse, and it is the patients themselves who decide the content of the consultation. Topics such as knowledge about the disease, endocarditis, acute situations, nutrition, contraception, alcohol/drugs, smoking, physical activity, sleep/rest, and education may be discussed. Parents are asked not to participate.

Managing ethical issues in patient care and the need for clinical ethics support.

PubMed

Doran, Evan; Fleming, Jennifer; Jordens, Christopher; Stewart, Cameron L; Letts, Julie; Kerridge, Ian H

2015-02-01

To investigate the range, frequency and management of ethical issues encountered by clinicians working in hospitals in New South Wales (NSW), Australia. A cross-sectional survey was conducted of a convenience sample of 104 medical, nursing and allied health professionals in two NSW hospitals. Some respondents did not provide data for some questions, therefore the denominator is less than 105 for some items. Sixty-two (62/104; 60%) respondents reported occasionally to often having ethical concerns. Forty-six (46/105; 44%) reported often to occasionally having legal concerns. The three most common responses to concerns were: talking to colleagues (96/105; 91%); raising the issue in a group forum (68/105; 65%); and consulting a relevant guideline (64/105; 61%). Most respondents were highly (65/99; 66%) or moderately (33/99; 33%) satisfied with the ethical environment of the hospital. Twenty-two (22/98; 22%) were highly satisfied with the ethical environment of their department and 74 (74/98; 76%) were moderately satisfied. Most (72/105; 69%) respondents indicated that additional support in dealing with ethical issues would be helpful. Clinicians reported frequently experiencing ethical and legal uncertainty and concern. They usually managed this by talking with colleagues. Although this approach was considered adequate, and the ethics of their hospital was reported to be satisfactory, most respondents indicated that additional assistance with ethical and legal concerns would be helpful. Clinical ethics support should be a priority of public hospitals in NSW and elsewhere in Australia.

Canadian Paediatric Neurology Workforce Survey and Consensus Statement.

PubMed

Doja, Asif; Orr, Serena L; McMillan, Hugh J; Kirton, Adam; Brna, Paula; Esser, Michael; Tang-Wai, Richard; Major, Philippe; Poulin, Chantal; Prasad, Narayan; Selby, Kathryn; Weiss, Shelly K; Yeh, E Ann; Callen, David Ja

2016-05-01

Little knowledge exists on the availability of academic and community paediatric neurology positions. This knowledge is crucial for making workforce decisions. Our study aimed to: 1) obtain information regarding the availability of positions for paediatric neurologists in academic centres; 2) survey paediatric neurology trainees regarding their perceptions of employment issues and career plans; 3) survey practicing community paediatric neurologists 4) convene a group of paediatric neurologists to develop consensus regarding how to address these workforce issues. Surveys addressing workforce issues regarding paediatric neurology in Canada were sent to: 1) all paediatric neurology program directors in Canada (n=9) who then solicited information from division heads and from paediatric neurologists in surrounding areas; 2) paediatric neurology trainees in Canada (n=57) and; 3) community paediatric neurologists (n=27). A meeting was held with relevant stakeholders to develop a consensus on how to approach employment issues. The response rate was 100% from program directors, 57.9% from residents and 44% from community paediatric neurologists. We found that the number of projected positions in academic paediatric neurology is fewer than the number of paediatric neurologists that are being trained over the next five to ten years, despite a clinical need for paediatric neurologists. Paediatric neurology residents are concerned about job availability and desire more career counselling. There is a current and projected clinical demand for paediatric neurologists despite a lack of academic positions. Training programs should focus on community neurology as a viable career option.

Clinical judicial syndrome: The impact of judicial proceedings on doctors.

PubMed

Arimany-Manso, Josep; Vizcaíno, Marta; Gómez-Durán, Esperanza L

2018-04-28

Complaints of alleged malpractice are a concern for doctors, however the impact these complaints have on them receives little attention. We present a systematic review of the scientific literature by searching the MEDLINE database, without no time limit, of manuscripts on doctors' reaction to a malpractice claim, carried out in Spanish, English and French. Their methodological quality was evaluated, and the results were analysed. The search identified a total of 18 articles, mostly without empirical sample analysis, which described the clinical judicial syndrome construct, its symptomatology, prevalence, etiopathogenesis and issues of prevention and approach. The literature on this subject is very scarce and has poor empirical foundation. However, the available data underscored the relevance of the impact that these complaints have on doctors and highlight the need to establish preventive measures and approaches to the so-called clinical judicial syndrome. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Intraoperative irradiation: precision medicine for quality cancer control promotion.

PubMed

Calvo, Felipe A

2017-02-02

Intraoperative irradiation was implemented 4 decades ago, pioneering the efforts to improve precision in local cancer therapy by combining real-time surgical exploration/resection with high single dose radiotherapy (Gunderson et al., Intraoperative irradiation: techniques and results, 2011). Clinical and technical developments have led to very precise radiation dose deposit. The ability to deliver a very precise dose of radiation is an essential element of contemporary multidisciplinary individualized oncology.This issue of Radiation Oncology contains a collection of expert review articles and updates with relevant data regarding intraoperative radiotherapy. Technology, physics, biology of single dose and clinical results in a variety of cancer sites and histologies are described and analyzed. The state of the art for advanced cancer care through medical innovation opens a significant opportunity for individualize cancer management across a broad spectrum of clinical practice. The advantage for tailoring diagnostic and treatment decisions in an individualized fashion will translate into precise medical treatment.

Adaptive change in electrically stimulated muscle: a framework for the design of clinical protocols.

PubMed

Salmons, Stanley

2009-12-01

Adult mammalian skeletal muscles have a remarkable capacity for adapting to increased use. Although this behavior is familiar from the changes brought about by endurance exercise, it is seen to a much greater extent in the response to long-term neuromuscular stimulation. The associated phenomena include a markedly increased resistance to fatigue, and this is the key to several clinical applications. However, a more rational basis is needed for designing regimes of stimulation that are conducive to an optimal outcome. In this review I examine relevant factors, such as the amount, frequency, and duty cycle of stimulation, the influence of force generation, and the animal model. From these considerations a framework emerges for the design of protocols that yield an overall functional profile appropriate to the application. Three contrasting examples illustrate the issues that need to be addressed clinically.

Immunotoxins: magic bullets or misguided missiles?

PubMed

Vitetta, E S; Thorpe, P E; Uhr, J W

1993-05-01

Thirteen years have passed since specific in vitro and in vivo killing of tumour cells by immunotoxins was first described. Why, then, has it taken so long to determine whether these drugs will have a major impact on the treatment of cancer, AIDS and autoimmune disease? The answer is that the transfer of basic discoveries to the clinic is a slow, multistep, interdisciplinary process. Thus, immunotoxin molecules must be designed and redesigned by the basic scientist depending on the efficacy and toxicity shown in vitro and in relevant experimental models. Next, each version must be evaluated by clinicians in humans through a lengthy process (1-3 years) in which the dose regimen is optimized and in which new problems and issues frequently emerge. These problems must again be modelled and studied in animals before additional clinical trials are initiated. In this article, Ellen Vitetta and colleagues discuss both basic and clinical aspects of the development of immunotoxin therapy.

Road Map For Diffusion Of Innovation In Health Care.

PubMed

Balas, E Andrew; Chapman, Wendy W

2018-02-01

New scientific knowledge and innovation are often slow to disseminate. In other cases, providers rush into adopting what appears to be a clinically relevant innovation, based on a single clinical trial. In reality, adopting innovations without appropriate translation and repeated testing of practical application is problematic. In this article we provide examples of clinical innovations (for example, tight glucose control in critically ill patients) that were adopted inappropriately and that caused what we term a malfunction. To address the issue of malfunctions, we review various examples and suggest frameworks for the diffusion of knowledge leading to the adoption of useful innovations. The resulting model is termed an integrated road map for coordinating knowledge transformation and innovation adoption. We make recommendations for the targeted development of practice change procedures, practice change assessment, structured descriptions of tested interventions, intelligent knowledge management technologies, and policy support for knowledge transformation, including further standardization to facilitate sharing among institutions.

Experts' Views Regarding the Conceptualization of Narcissism.

PubMed

Ackerman, Robert A; Hands, Aaron J; Donnellan, M Brent; Hopwood, Christopher J; Witt, Edward A

2017-06-01

There is debate over the definition of narcissism across social/personality and clinical psychology. The current article aims to quantify the level of disagreement by measuring experts' opinions concerning the attributes most central to narcissism. Accordingly, we developed a comprehensive list of attributes associated with narcissism and had 49 self-identified experts (among them 17 women, 23 psychologists from clinical psychology and 22 from social/personality psychology) rate these characteristics and provide their opinions on several issues related to the conceptualization of narcissism. Experts generally believe that the grandiose features of narcissism are more central than the vulnerable features. However, differences between clinical and social/personality psychologists were evident, especially regarding the relevance of self-esteem. Given the results, we suggest that researchers specify the kind of narcissism being assessed in a given study and consider using assessments of the full range of narcissistic features in future research to provide a more comprehensive perspective on the construct.

Robotics: The next step?

PubMed

Broeders, Ivo A M J

2014-02-01

Robotic systems were introduced 15 years ago to support complex endoscopic procedures. The technology is increasingly used in gastro-intestinal surgery. In this article, literature on experimental- and clinical research is reviewed and ergonomic issues are discussed. literature review was based on Medline search using a large variety of search terms, including e.g. robot(ic), randomized, rectal, oesophageal, ergonomics. Review articles on relevant topics are discussed with preference. There is abundant evidence of supremacy in performing complex endoscopic surgery tasks when using the robot in an experimental setting. There is little high-level evidence so far on translation of these merits to clinical practice. Robotic systems may appear helpful in complex gastro-intestinal surgery. Moreover, dedicated computer based technology integrated in telepresence systems opens the way to integration of planning, diagnostics and therapy. The first high tech add-ons such as near infrared technology are under clinical evaluation. Copyright © 2014 Elsevier Ltd. All rights reserved.

Exploring the potential duty of care in clinical genomics under UK law

PubMed Central

Mitchell, Colin; Ploem, Corrette; Chico, Victoria; Ormondroyd, Elizabeth; Hall, Alison; Wallace, Susan; Fay, Michael; Goodwin, Deirdre; Bell, Jessica; Phillips, Simon; Taylor, Jenny C.; Hennekam, Raoul; Kaye, Jane

2017-01-01

Genome-wide sequencing technologies are beginning to be used in projects that have both clinical diagnostic and research components. The clinical application of this technology, which generates a huge amount of information of varying diagnostic certainty, involves addressing a number of challenges to establish appropriate standards. In this article, we explore the way that UK law may respond to three of these key challenges and could establish new legal duties in relation to feedback of findings that are unrelated to the presenting condition (secondary, additional or incidental findings); duties towards genetic relatives as well as the patient and duties on the part of researchers and professionals who do not have direct contact with patients. When considering these issues, the courts will take account of European and international comparisons, developing guidance and relevant ethical, social and policy factors. The UK courts will also be strongly influenced by precedent set in case law. PMID:28943725

Exploring the potential duty of care in clinical genomics under UK law.

PubMed

Mitchell, Colin; Ploem, Corrette; Chico, Victoria; Ormondroyd, Elizabeth; Hall, Alison; Wallace, Susan; Fay, Michael; Goodwin, Deirdre; Bell, Jessica; Phillips, Simon; Taylor, Jenny C; Hennekam, Raoul; Kaye, Jane

2017-09-01

Genome-wide sequencing technologies are beginning to be used in projects that have both clinical diagnostic and research components. The clinical application of this technology, which generates a huge amount of information of varying diagnostic certainty, involves addressing a number of challenges to establish appropriate standards. In this article, we explore the way that UK law may respond to three of these key challenges and could establish new legal duties in relation to feedback of findings that are unrelated to the presenting condition (secondary, additional or incidental findings); duties towards genetic relatives as well as the patient and duties on the part of researchers and professionals who do not have direct contact with patients. When considering these issues, the courts will take account of European and international comparisons, developing guidance and relevant ethical, social and policy factors. The UK courts will also be strongly influenced by precedent set in case law.

The use of propofol by gastroenterologists: medico-legal issues.

PubMed

Axon, Andrew E

2010-01-01

The increasing use of non-anesthesiologist-administered propofol for sedation during gastrointestinal endoscopy has both clinical and legal consequences. As medical practices develop, the law of clinical negligence will be applied in the context of such developments. While the law will recognize the desirability of advanced techniques and methods, in circumstances where an injury or adverse outcome occurs, the facts of a particular case will be scrutinized to determine whether or not the duty of care between patient and clinician has been breached. This paper considers a number of specific matters likely to arise in the context of a clinical negligence/malpractice claim resulting from the use of non-anesthesiologist-administered propofol, in particular the role and standard of care expected of gastroenterologist and/or anesthetic provider, the relevance of FDA labeling, the implementation and use of protocols, the importance of patient selection and informed consent. Copyright 2010 S. Karger AG, Basel.

A new quality of bone ultrasound research.

PubMed

Gluer, C C

2008-07-01

Quantitative ultrasound (QUS) methods have strong power to predict osteoporotic fractures, but they are also very relevant for the assessment of bone quality. A representative sample of recent studies addressing these topics can be found in this special issue. Further pursuit of these methods will establish micro-QUS imaging methods as tools for measuring specific aspects of bone quality. Once this is achieved, we will be able to link such data to the clinical QUS methods used in vivo to determine which aspects of bone quality cause QUS to be a predictor of fracture risk that is independent of bone mineral density (BMD). Potentially this could lead to the development of a new generation of QUS devices for improved and expanded clinical assessment. Good quality of basic science work will thus lead to good quality of clinical patient examinations on the basis of a more detailed assessment of bone quality.

Diet and psychological health.

PubMed

Miller, M

1996-09-01

This article reviews research that suggests a relationship between diet and psychological symptoms. Mind-body dualism (as it relates to clinical practice) and the limited role of nutrition in mainstream biomedical training and treatment are discussed as background issues. Two areas of inquiry that have generated relevant research findings in this area are reviewed: (1) orthomolecular theory and vitamin deficiencies, and (2) clinical ecology/environmental medicine theory and the impact of "food allergies." Although clinical case reports and promising research findings have been reported, the impact of diet on psychological health is neither widely accepted nor integrated into mental health treatment methods. Ongoing research findings in brain biochemistry and psychoneuroimmunology point to communication pathways that can provide a clearer understanding of the links between nutritional intake, central nervous system and immune function, and psychological health status. These findings may lead to greater acceptance of dietary treatment approaches among health practitioners addressing psychological disorders.

The lack of a big picture in tuberculosis: the clinical point of view, the problems of experimental modeling and immunomodulation. The factors we should consider when designing novel treatment strategies

PubMed Central

Vilaplana, Cristina; Cardona, Pere-Joan

2014-01-01

This short review explores the large gap between clinical issues and basic science, and suggests why tuberculosis research should focus on redirect the immune system and not only on eradicating Mycobacterium tuberculosis bacillus. Along the manuscript, several concepts involved in human tuberculosis are explored in order to understand the big picture, including infection and disease dynamics, animal modeling, liquefaction, inflammation and immunomodulation. Scientists should take into account all these factors in order to answer questions with clinical relevance. Moreover, the inclusion of the concept of a strong inflammatory response being required in order to develop cavitary tuberculosis disease opens a new field for developing new therapeutic and prophylactic tools in which destruction of the bacilli may not necessarily be the final goal. PMID:24592258

The lack of a big picture in tuberculosis: the clinical point of view, the problems of experimental modeling and immunomodulation. The factors we should consider when designing novel treatment strategies.

PubMed

Vilaplana, Cristina; Cardona, Pere-Joan

2014-01-01

This short review explores the large gap between clinical issues and basic science, and suggests why tuberculosis research should focus on redirect the immune system and not only on eradicating Mycobacterium tuberculosis bacillus. Along the manuscript, several concepts involved in human tuberculosis are explored in order to understand the big picture, including infection and disease dynamics, animal modeling, liquefaction, inflammation and immunomodulation. Scientists should take into account all these factors in order to answer questions with clinical relevance. Moreover, the inclusion of the concept of a strong inflammatory response being required in order to develop cavitary tuberculosis disease opens a new field for developing new therapeutic and prophylactic tools in which destruction of the bacilli may not necessarily be the final goal.

Amitriptyline for the treatment of fibromyalgia: a comprehensive review.

PubMed

Rico-Villademoros, Fernando; Slim, Mahmoud; Calandre, Elena P

2015-10-01

Fibromyalgia is characterized by chronic generalized pain accompanied by a wide range of clinical manifestations. Most clinical practice guidelines recommend multidisciplinary treatment using a combination of pharmacological and non-pharmacological therapies. The tricyclic antidepressant amitriptyline has been most thoroughly studied in fibromyalgia. Amitriptyline has been evaluated in placebo-controlled studies, and it has served as an active comparator to other therapeutic interventions in the treatment of fibromyalgia. In addition, several systematic reviews and meta-analyses have evaluated its efficacy and safety for the treatment of fibromyalgia. Data from individual studies as well as from systematic reviews indicate that low doses (10-75 mg/day) of amitriptyline are effective for the treatment of fibromyalgia and, despite the limited quality of the data, they do not seem to be associated with relevant tolerability or safety issues. Consistent with some clinical guidelines, we believe amitriptyline in low doses should be considered a first-line drug for the treatment of fibromyalgia.

Clinical guidelines for the treatment of depressive disorders. II. Principles of management.

PubMed

Reesal, R T; Lam, R W

2001-06-01

The Canadian Psychiatric Association and the Canadian Network for Mood and Anxiety Treatments partnered to produce clinical guidelines for psychiatrists for the treatment of depressive disorders. A standard guidelines development process was followed. Relevant literature was identified using a computerized Medline search supplemented by review of bibliographies. Operational criteria were used to rate the quality of scientific evidence, and the line of treatment recommendations included consensus clinical opinion. This section on "Principles of Management" is 1 of 7 articles drafted and reviewed by clinicians. Revised drafts underwent national and international expert peer review. The principles and goals of psychiatric management with psychotherapy and pharmacotherapy are reviewed. Two phases of treatment, acute and maintenance, are identified. Special topics, including inpatient management, suicide management, and medical-legal issues are also discussed. These principles of psychiatric management provide a framework for the use of specific treatments for depressive disorders.

The Criteria People Use in Relevance Decisions on Health Information: An Analysis of User Eye Movements When Browsing a Health Discussion Forum.

PubMed

Pian, Wenjing; Khoo, Christopher Sg; Chang, Yun-Ke

2016-06-20

People are increasingly accessing health-related social media sites, such as health discussion forums, to post and read user-generated health information. It is important to know what criteria people use when deciding the relevance of information found on health social media websites, in different situations. The study attempted to identify the relevance criteria that people use when browsing a health discussion forum, in 3 types of use contexts: when seeking information for their own health issue, when seeking for other people's health issue, and when browsing without a particular health issue in mind. A total of 58 study participants were self-assigned to 1 of the 3 use contexts or information needs and were asked to browse a health discussion forum, HealthBoards.com. In the analysis, browsing a discussion forum was divided into 2 stages: scanning a set of post surrogates (mainly post titles) in the summary result screen and reading a detailed post content (including comments by other users). An eye tracker system was used to capture participants' eye movement behavior and the text they skim over and focus (ie, fixate) on during browsing. By analyzing the text that people's eyes fixated on, the types of health information used in the relevance judgment were determined. Post-experiment interviews elicited participants' comments on the relevance of the information and criteria used. It was found that participants seeking health information for their own health issue focused significantly more on the poster's symptoms, personal history of the disease, and description of the disease (P=.01, .001, and .02). Participants seeking for other people's health issue focused significantly more on cause of disease, disease terminology, and description of treatments and procedures (P=.01, .01, and .02). In contrast, participants browsing with no particular issue in mind focused significantly more on general health topics, hot topics, and rare health issues (P=.01, .01, and .01). Users browsing for their own health issues used mainly case-based relevance criteria to relate the poster's health situation to their own. Participants seeking for others' issues used mostly general knowledge-based criteria, whereas users with no particular issue in mind used general interest- and curiosity-based criteria.

The Criteria People Use in Relevance Decisions on Health Information: An Analysis of User Eye Movements When Browsing a Health Discussion Forum

PubMed Central

Khoo, Christopher SG; Chang, Yun-Ke

2016-01-01

Background People are increasingly accessing health-related social media sites, such as health discussion forums, to post and read user-generated health information. It is important to know what criteria people use when deciding the relevance of information found on health social media websites, in different situations. Objective The study attempted to identify the relevance criteria that people use when browsing a health discussion forum, in 3 types of use contexts: when seeking information for their own health issue, when seeking for other people’s health issue, and when browsing without a particular health issue in mind. Methods A total of 58 study participants were self-assigned to 1 of the 3 use contexts or information needs and were asked to browse a health discussion forum, HealthBoards.com. In the analysis, browsing a discussion forum was divided into 2 stages: scanning a set of post surrogates (mainly post titles) in the summary result screen and reading a detailed post content (including comments by other users). An eye tracker system was used to capture participants’ eye movement behavior and the text they skim over and focus (ie, fixate) on during browsing. By analyzing the text that people’s eyes fixated on, the types of health information used in the relevance judgment were determined. Post-experiment interviews elicited participants’ comments on the relevance of the information and criteria used. Results It was found that participants seeking health information for their own health issue focused significantly more on the poster’s symptoms, personal history of the disease, and description of the disease (P=.01, .001, and .02). Participants seeking for other people’s health issue focused significantly more on cause of disease, disease terminology, and description of treatments and procedures (P=.01, .01, and .02). In contrast, participants browsing with no particular issue in mind focused significantly more on general health topics, hot topics, and rare health issues (P=.01, .01, and .01). Conclusion Users browsing for their own health issues used mainly case-based relevance criteria to relate the poster's health situation to their own. Participants seeking for others’ issues used mostly general knowledge–based criteria, whereas users with no particular issue in mind used general interest– and curiosity-based criteria. PMID:27323893

Development, implementation and outcome analysis of semi-automated alerts for metformin dose adjustment in hospitalized patients with renal impairment.

PubMed

Niedrig, David; Krattinger, Regina; Jödicke, Annika; Gött, Carmen; Bucklar, Guido; Russmann, Stefan

2016-10-01

Overdosing of the oral antidiabetic metformin in impaired renal function is an important contributory cause to life-threatening lactic acidosis. The presented project aimed to quantify and prevent this avoidable medication error in clinical practice. We developed and implemented an algorithm into a hospital's clinical information system that prospectively identifies metformin prescriptions if the estimated glomerular filtration rate is below 60 mL/min. Resulting real-time electronic alerts are sent to clinical pharmacologists and pharmacists, who validate cases in electronic medical records and contact prescribing physicians with recommendations if necessary. The screening algorithm has been used in routine clinical practice for 3 years and generated 2145 automated alerts (about 2 per day). Validated expert recommendations regarding metformin therapy, i.e., dose reduction or stop, were issued for 381 patients (about 3 per week). Follow-up was available for 257 cases, and prescribers' compliance with recommendations was 79%. Furthermore, during 3 years, we identified eight local cases of lactic acidosis associated with metformin therapy in renal impairment that could not be prevented, e.g., because metformin overdosing had occurred before hospitalization. Automated sensitive screening followed by specific expert evaluation and personal recommendations can prevent metformin overdosing in renal impairment with high efficiency and efficacy. Repeated cases of metformin-associated lactic acidosis in renal impairment underline the clinical relevance of this medication error. Our locally developed and customized alert system is a successful proof of concept for a proactive clinical drug safety program that is now expanded to other clinically and economically relevant medication errors. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

AGING AND TOXIC RESPONSE: ISSUES RELEVANT TO RISK ASSESSMENT (FINAL)

EPA Science Inventory

EPA has released a final report entitled, Aging and Toxic Response: Issues Relevant to Risk Assessment. This document contributes to the Agency's efforts to better understand the physiology of aging in order to protect the health of older persons, and identifies several d...

Review of Antimicrobial Resistance in the Environment and Its Relevance to Environmental Regulators.

PubMed

Singer, Andrew C; Shaw, Helen; Rhodes, Vicki; Hart, Alwyn

2016-01-01

The environment is increasingly being recognized for the role it might play in the global spread of clinically relevant antibiotic resistance. Environmental regulators monitor and control many of the pathways responsible for the release of resistance-driving chemicals into the environment (e.g., antimicrobials, metals, and biocides). Hence, environmental regulators should be contributing significantly to the development of global and national antimicrobial resistance (AMR) action plans. It is argued that the lack of environment-facing mitigation actions included in existing AMR action plans is likely a function of our poor fundamental understanding of many of the key issues. Here, we aim to present the problem with AMR in the environment through the lens of an environmental regulator, using the Environment Agency (England's regulator) as an example from which parallels can be drawn globally. The issues that are pertinent to environmental regulators are drawn out to answer: What are the drivers and pathways of AMR? How do these relate to the normal work, powers and duties of environmental regulators? What are the knowledge gaps that hinder the delivery of environmental protection from AMR? We offer several thought experiments for how different mitigation strategies might proceed. We conclude that: (1) AMR Action Plans do not tackle all the potentially relevant pathways and drivers of AMR in the environment; and (2) AMR Action Plans are deficient partly because the science to inform policy is lacking and this needs to be addressed.

Assisted dying in liberalised jurisdictions and the role of psychiatry: a clinician's view.

PubMed

Macleod, Sandy

2012-10-01

Assisted dying is a contentious and topical issue. Mental disorder is a relevant influence on requests of hastened death. The psychiatry of dying is not a prominent component in the assessment of euthanasia and physician-assisted suicide (PAS) in jurisdictions with liberalised assisted dying laws. The literature on the assessment processes, with particular reference to mental status, involved in euthanasia requests is considered. An experienced palliative medicine specialist and psychiatrist selectively reviewed the recent literature published about the mental health issues involved in euthanasia and PAS. Assessments of competency, sustained wish to die prematurely, depressive disorder, demoralisation and 'unbearable suffering' in the terminally ill are clinically uncertain and difficult tasks. There is a growing psychiatric and psychological literature on the mental status of the terminally ill. As yet psychiatry does not have the expertise to 'select' those whose wish for hastened death is rational, humane and 'healthy'. Rarely in those societies with liberalised assisted dying laws are psychiatrists involved in the decision-making for individuals requesting early death. This role is fulfilled by non-specialists. There remain significant concerns about the accuracy of psychiatric assessment in the terminally ill. Mental processes are more relevant influences on a hastened wish to die than are the physical symptoms of terminal malignant disease. Psychiatric review of persons requesting euthanasia is relevant. It is not obligatory or emphasised in those legislations allowing assisted dying. Psychiatry needs to play a greater role in the assessment processes of euthanasia and PAS.

Review of Antimicrobial Resistance in the Environment and Its Relevance to Environmental Regulators

PubMed Central

Singer, Andrew C.; Shaw, Helen; Rhodes, Vicki; Hart, Alwyn

2016-01-01

The environment is increasingly being recognized for the role it might play in the global spread of clinically relevant antibiotic resistance. Environmental regulators monitor and control many of the pathways responsible for the release of resistance-driving chemicals into the environment (e.g., antimicrobials, metals, and biocides). Hence, environmental regulators should be contributing significantly to the development of global and national antimicrobial resistance (AMR) action plans. It is argued that the lack of environment-facing mitigation actions included in existing AMR action plans is likely a function of our poor fundamental understanding of many of the key issues. Here, we aim to present the problem with AMR in the environment through the lens of an environmental regulator, using the Environment Agency (England’s regulator) as an example from which parallels can be drawn globally. The issues that are pertinent to environmental regulators are drawn out to answer: What are the drivers and pathways of AMR? How do these relate to the normal work, powers and duties of environmental regulators? What are the knowledge gaps that hinder the delivery of environmental protection from AMR? We offer several thought experiments for how different mitigation strategies might proceed. We conclude that: (1) AMR Action Plans do not tackle all the potentially relevant pathways and drivers of AMR in the environment; and (2) AMR Action Plans are deficient partly because the science to inform policy is lacking and this needs to be addressed. PMID:27847505

Guidelines for psychological practice with older adults.

PubMed

2014-01-01

The "Guidelines for Psychological Practice With Older Adults" are intended to assist psychologists in evaluating their own readiness for working with older adults and in seeking and using appropriate education and training to increase their knowledge, skills, and experience relevant to this area of practice. The specific goals of these professional practice guidelines are to provide practitioners with (a) a frame of reference for engaging in clinical work with older adults and (b) basic information and further references in the areas of attitudes, general aspects of aging, clinical issues, assessment, intervention, consultation, professional issues, and continuing education and training relative to work with this group. The guidelines recognize and appreciate that there are numerous methods and pathways whereby psychologists may gain expertise and/or seek training in working with older adults. This document is designed to offer recommendations on those areas of awareness, knowledge, and clinical skills considered as applicable to this work, rather than prescribing specific training methods to be followed. The guidelines also recognize that some psychologists will specialize in the provision of services to older adults and may therefore seek more extensive training consistent with practicing within the formally recognized specialty of Professional Geropsychology (APA, 2010c). PsycINFO Database Record (c) 2014 APA, all rights reserved.

Healthcare professionals' agreement on clinical relevance of drug-related problems among elderly patients.

PubMed

Bech, Christine Flagstad; Frederiksen, Tine; Villesen, Christine Tilsted; Højsted, Jette; Nielsen, Per Rotbøll; Kjeldsen, Lene Juel; Nørgaard, Lotte Stig; Christrup, Lona Louring

2018-02-01

Background Disagreement among healthcare professionals on the clinical relevance of drug-related problems can lead to suboptimal treatment and increased healthcare costs. Elderly patients with chronic non-cancer pain and comorbidity are at increased risk of drug related problems compared to other patient groups due to complex medication regimes and transition of care. Objective To investigate the agreement among healthcare professionals on their classification of clinical relevance of drug-related problems in elderly patients with chronic non-cancer pain and comorbidity. Setting Multidisciplinary Pain Centre, Rigshospitalet, Copenhagen, Denmark. Method A pharmacist performed medication review on elderly patients with chronic non-cancer pain and comorbidity, identified their drug-related problems and classified these problems in accordance with an existing categorization system. A five-member clinical panel rated the drug-related problems' clinical relevance in accordance with a five-level rating scale, and their agreement was compared using Fleiss' κ. Main outcome measure Healthcare professionals' agreement on clinical relevance of drug related problems, using Fleiss' κ. Results Thirty patients were included in the study. A total of 162 drug related problems were identified, out of which 54% were of lower clinical relevance (level 0-2) and 46% of higher clinical relevance (level 3-4). Only slight agreement (κ = 0.12) was found between the panellists' classifications of clinical relevance using a five-level rating scale. Conclusion The clinical pharmacist identified drug related problems of lower and higher clinical relevance. Poor overall agreement on the severity of the drug related problems was found among the panelists.

Caring for women living with HIV: gaps in the evidence

PubMed Central

Loutfy, Mona R; Sherr, Lorraine; Sonnenberg-Schwan, Ulrike; Walmsley, Sharon L; Johnson, Margaret; d'Arminio Monforte, Antonella

2013-01-01

Introduction In the management of HIV, women and men generally undergo the same treatment pathway, with gender differences being given limited consideration. This is in spite of accumulating evidence that there are a number of potential differences between women and men which may affect response to treatment, pharmacokinetics, toxicities and coping. There are also notable psychological, behavioural, social and structural factors that may have a unique impact on women living with HIV (WLWH). Despite our increasing knowledge of HIV and advances in treatment, there are significant gaps in the data relating specifically to women. One of the factors contributing to this situation is the under-representation of women in all aspects of HIV clinical research. Furthermore, there are clinical issues unique to women, including gynaecologic and breast diseases, menopause-related factors, contraception and other topics related to women's and sexual health. Methods Using scoping review methodology, articles from the literature from 1980 to 2012 were identified using appropriate MeSH headings reflecting the clinical status of WLWH, particularly in the areas of clinical management, sexual health, emotional wellbeing and treatment access. Titles and abstracts were scanned to determine whether they were relevant to non-reproductive health in WLWH, and papers meeting inclusion criteria were reviewed. Results This review summarizes our current knowledge of the clinical status of WLWH, particularly in the areas of clinical management, sexual health, emotional wellbeing and treatment access. It suggests that there are a number of gender differences in disease and treatment outcomes, and distinct women-specific issues, such as menopause and co-morbidities, that pose significant challenges to the care of WLWH. Conclusions Based on a review of this evidence, outstanding questions and areas where further studies are required to determine gender differences in the efficacy and safety of treatment and other clinical and psychological issues specifically affecting WLWH have been identified. Well-controlled and adequately powered clinical studies are essential to help provide answers to these questions and to contribute to activities aimed at improving the health and wellbeing of WLWH. PMID:24088395

Improving the relevance and consistency of outcomes in comparative effectiveness research.

PubMed

Tunis, Sean R; Clarke, Mike; Gorst, Sarah L; Gargon, Elizabeth; Blazeby, Jane M; Altman, Douglas G; Williamson, Paula R

2016-03-01

Policy makers have clearly indicated--through heavy investment in the Patient Centered Outcomes Research Institute--that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues.

Improving the relevance and consistency of outcomes in comparative effectiveness research

PubMed Central

Tunis, Sean R; Clarke, Mike; Gorst, Sarah L; Gargon, Elizabeth; Blazeby, Jane M; Altman, Douglas G; Williamson, Paula R

2016-01-01

Policy makers have clearly indicated – through heavy investment in the Patient Centered Outcomes Research Institute – that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues. PMID:26930385

Is oral health a risk factor for sexual health?

PubMed

Eastham, Jane; Seymour, Robin

2015-03-01

New evidence suggests that the extent and severity of periodontal disease may be a significant risk factor for erectile dysfunction, sperm motility and time to conception. This paper reviews the evidence and informs members of the dental team when dealing with this sensitive issue. As more research is forthcoming the topic of oral and sexual health is likely to be part of regular routine medical screening. Any issue concerning oral health as a risk factor for sexual health is likely to be a sensitive subject, rarely discussed in the dental setting. However, as new evidence emerges, this topic is likely to get into the public domain. All members of the dental team should be aware of such an association. Clinical Relevance: Furthermore, the information in this paper may provide further incentive for certain patients to improve their oral health.

Establishing a Nation Wide Infrastructure for Systematic Use of Patient Reported Information.

PubMed

Jensen, Sanne; Lyng, Karen Marie

2018-01-01

In Denmark, we have set up a program to establish a nationwide infrastructure for Patient Reported Outcome (PRO) questionnaires. The effort is divided into an IT infrastructure part and a questionnaire development part. This paper describes how development and evaluation are closely knit together in the two tracks, as complexity is high in the PRO field and IT infrastructure, legal issues, various clinical workflows and the numerous stakeholders have to be taken into account concurrently. In the design process, we have thus used a participatory design approach to ensure a high level of active stakeholder involvement and capability of addressing all the relevant issues. In the next phases, we will apply the IT infrastructure in the planned full-scale evaluation of the questionnaires developed in the first phase, while we continue to develop new national questionnaires.

Overview of somatization: diagnosis, epidemiology, and management.

PubMed

Escobar, J I

1996-01-01

This article outlines critical issues in the psychiatric assessment of patients presenting with medically unexplained physical symptoms that form the core of the somatoform disorders in current nosologies. The prevalence of these disorders in communities and clinical settings emphasizes that a majority of these patients are primary care service users rather than mental health clients. A brief review of previous studies on the pharmacological management of these syndromes with antidepressants highlights unique features of these disorders that are relevant to the design of double-blind studies. The promising results emerging from some of these studies bring new excitement to the field that may help counter the prevailing therapeutic nihilism, thus attracting new investigators to this area. Finally, several caveats are provided on issues of research design and interpretation for the benefit of those entering this field of research.

Drug regulators and ethics: which GCP issues are also ethical issues?

PubMed

Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; Breekveldt, Nancy S; van Delden, Johannes J M

2016-02-01

Within the European Union (EU), good clinical practice (GCP) provides an ethical mandate to regulators; however, it is unclear what the content of that mandate is. By looking at the correspondence between GCP and ethical imperatives, we identify that the mandate is within the following: principles; benefit-risk ratio; scientific validity; results publication; informed consent; respect for participants; and special populations. There are also cases when regulations were ethical but were not pairable to an imperative, and when the former were stricter than the latter. Hence, we suggest closer cooperation between ethics committees and regulators to ensure that future versions of ethics guidelines cover the ethically relevant regulations that were not directly pairable to any imperative, and cooperation between GCP legislative bodies and ethics guideline-making bodies to resolve the discordant areas. Copyright © 2015 Elsevier Ltd. All rights reserved.

Sleep: important considerations for the prevention of cardiovascular disease.

PubMed

Grandner, Michael A; Alfonso-Miller, Pamela; Fernandez-Mendoza, Julio; Shetty, Safal; Shenoy, Sundeep; Combs, Daniel

2016-09-01

Sleep plays many roles in maintenance of cardiovascular health. This review summarizes the literature across several areas of sleep and sleep disorders in relation to cardiometabolic disease risk factors. Insufficient sleep duration is prevalent in the population and is associated with weight gain and obesity, inflammation, cardiovascular disease, diabetes, and mortality. Insomnia is also highly present and represents an important risk factor for cardiovascular disease, especially when accompanied by short sleep duration. Sleep apnea is a well-characterized risk factor for cardiometabolic disease and cardiovascular mortality. Other issues are relevant as well. For example, sleep disorders in pediatric populations may convey cardiovascular risks. Also, sleep may play an important role in cardiovascular health disparities. Sleep and sleep disorders are implicated in cardiometabolic disease risk. This review addresses these and other issues, concluding with recommendations for research and clinical practice.

Point-of-Care Detection Devices for Food Safety Monitoring: Proactive Disease Prevention.

PubMed

Wu, Marie Yung-Chen; Hsu, Min-Yen; Chen, Shih-Jen; Hwang, De-Kuang; Yen, Tzung-Hai; Cheng, Chao-Min

2017-04-01

Food safety has become an increasingly significant public concern in both developed and under-developed nations around the world; it increases morbidity, mortality, human suffering, and economic burden. This Opinion focuses on (i) examining the influence of pathogens and chemicals (e.g., food additives and pesticide residue) on food-borne illnesses, (ii) summarizing food hazards that are present in Asia, and (iii) summarizing the array of current point-of-care (POC) detection devices that have potential applications in food safety monitoring. In addition, we provide insight into global healthcare issues in both developing and under-developed nations with a focus on bridging the gap between food safety issues in the public sector (associated with relevant clinical cases) and the use of POC detection devices for food safety monitoring. Copyright © 2016 Elsevier Ltd. All rights reserved.

Emergency Health Preparedness: Expectations for Teachers.

ERIC Educational Resources Information Center

Winkelman, Jack L.

Specific issues relevant to the emergency health preparedness of schools and the key roles and expectations applicable to teachers are outlined. It is noted that, while issues of legal liability relevant to teachers are complex, teachers are expected to: (1) anticipate possible risk or harm involved in activities; (2) give adequate warning of…

[Reflections on qualitative research. Interview of Luisa Saiani with Luigina Mortari].

PubMed

Mortari, Luigina; Saiani, Luisa

2013-01-01

Reflections on qualitative research. Interview of Luisa Saiani to Luigina Mortari. Luigina Mortari, an internationally known expert of epistemology and qualitative research, was interviewed to explore her thoughts on issues relevant for qualitative research: when a research question can be considered relevant; key methodological elements; ethical issues.

77 FR 43575 - Intent To Prepare a Draft Environmental Impact Statement/Environmental Impact Report for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-25

..., identifying significant environmental issues in the DEIS/EIR, providing useful information such as published and unpublished data, and knowledge of relevant issues and recommending mitigation measures to offset... the scoping process. c. Individuals and agencies may offer information or data relevant to the...

Incidental findings in multislice computed tomography prior to transcatheter aortic valve implantation: frequency, clinical relevance and outcome.

PubMed

Trenkwalder, Teresa; Lahmann, Anna Lena; Nowicka, Magdalena; Pellegrini, Costanza; Rheude, Tobias; Mayr, N Patrick; Voss, Stephanie; Bleiziffer, Sabine; Lange, Rüdiger; Joner, Michael; Kasel, Albert M; Kastrati, Adnan; Schunkert, Heribert; Husser, Oliver; Hadamitzky, Martin; Hengstenberg, Christian

2018-02-21

Multislice computed tomography (MSCT) has emerged as the mainstay in patients planned for transcatheter aortic valve implantation (TAVI). Incidental findings (IF) in MSCT are common. However, the exact incidence, clinical relevance and further consequences of IF are unclear and it is controversial whether IF adversely affect patients' outcome. We analyzed MSCT data of 1050 patients screened for TAVI between January 2011 and December 2014. Median follow-up of patients was 20 months. In total, 3194 IF were identified, which were classified into clinically non-relevant IF (2872, 90%) and clinically relevant IF (322, 10%). In 25% of patients (258/1050) at least one clinically relevant IF was present. Age (80 ± 7 vs. 80 ± 7 years; p = 0.198) and EuroSCORE II (3.6% [2.1-5.7] vs. 3.6% [2.1-5.9]; p = 0.874) was similar between patients with and without a clinically relevant IF. TAVI was performed less frequently in patients with a clinically relevant IF (76% vs. 85%; p < 0.001), with more patients receiving surgical aortic valve replacement in that group (14% vs. 11%; p = 0.042), possibly due to the high rate of incidental aneurysms of the ascending aorta (n = 48). If TAVI was performed mortality did not differ (30-days: 4% vs. 3%; p = 0.339, 1-year: 11% vs. 14%; p = 0.226) between patients with and without a clinically relevant IF. Our study is the largest study to analyze prevalence, clinical relevance and therapeutic consequences of IF during screening for TAVI. IF in pre-procedural MSCT are common and clinically relevant in one-quarter of patients. However, these findings had no impact on overall mortality.

Consultation-liaison psychiatry and psychosomatic medicine: the company they keep.

PubMed

Lipsitt, D R

2001-01-01

The objectives of this review are 1) to briefly describe the parallel historical developments of consultation-liaison (C-L) psychiatry and psychosomatic medicine [corrected]; 2) to analyze the extent to which the literature of C-L psychiatry and psychosomatic medicine relate to each other, given that both fields have evolved simultaneously in the history of psychiatry; and 3) to propose possible explanations for observed publication patterns in selected C-L resources and the journal Psychosomatic Medicine. The quasi-citation analysis includes two segments: 1) a review of selected key C-L psychiatry references to determine the extent to which classic articles from Psychosomatic Medicine are cited; and 2) an analysis of 60 years of Psychosomatic Medicine, sampling issues from the first 5 years of each decade and all issues of the year 2000 for articles of potential relevance to C-L psychiatry. References to Psychosomatic Medicine articles in C-L resources are tallied as percentages of total references in each source. Articles in Psychosomatic Medicine are assigned to one of three categories (A, B, or C) according to their perceived relevance to C-L psychiatry, from most (A) to least (C) relevant. The review of C-L sources ("basic" reading lists and reference lists of seminal articles and textbooks) revealed a wide range of Psychosomatic Medicine citations, from 0% to 27.4% (average, 7.5%). The survey of Psychosomatic Medicine sorted 1705 articles for their relevance to C-L psychiatry into category A (9.5-40.6%, average 21.3%), category B (70.4-86.3%, average 72.3%), and category C (0.7-12.1%, average 6.4%) for each half-decade for the past 60 years. The lowest number of category A articles appeared in the years 1970 to 1975, and the highest number appeared in 1950 to 1955; reciprocal results were found for category B articles. The lowest number of category C articles appeared in 1980 to 1985, and the highest number appeared in 1940 to 1945. For the six issues of 2000, the distributions of articles in categories A, B, and C are similar, continuing an upward trend beginning in 1975 of core (category A) articles. Explanations for publication patterns are speculatively related to various factors, such as a paucity of C-L research and researchers, the broad definition of C-L psychiatry, editorial policies, and the impact of World War II. Although C-L psychiatry and psychosomatic medicine have common roots, the reliance of the C-L literature on classic Psychosomatic Medicine articles has varied markedly, from none to about one-quarter of its references. Nevertheless, Psychosomatic Medicine has consistently published articles of theoretical and clinical interest to C-L psychiatrists, with more than 90% of published articles considered to be of high or moderate relevance to C-L psychiatry. A far higher percentage of articles in Psychosomatic Medicine would seem to be relevant to the field of C-L psychiatry than are cited in significant C-L literature. Psychosomatic Medicine's essential focus on empirical research may dissuade the more clinically oriented C-L psychiatrists.

Advancing our understanding of religion and spirituality in the context of behavioral medicine.

PubMed

Park, Crystal L; Masters, Kevin S; Salsman, John M; Wachholtz, Amy; Clements, Andrea D; Salmoirago-Blotcher, Elena; Trevino, Kelly; Wischenka, Danielle M

2017-02-01

Recognizing and understanding the potentially powerful roles that religiousness and spirituality (RS) may serve in the prevention and amelioration of disease, as well as symptom management and health related quality of life, significantly enhances research and clinical efforts across many areas of behavioral medicine. This article examines the knowledge established to date and suggests advances that remain to be made. We begin with a brief summary of the current knowledge regarding RS as related to three exemplary health conditions: (a) cardiovascular disease; (b) cancer; and, (c) substance abuse. We then focus on particular concerns for future investigations, emphasizing conceptual issues, possible mediators and moderators of relationships or effects, and methodology. Our discussion is framed by a conceptual model that may serve to guide and organize future investigations. This model highlights a number of important issues regarding the study of links between RS and health: (a) RS comprise many diverse constructs, (b) the mechanisms through which RS may influence health outcomes are quite diverse, and (c) a range of different types of health and health relevant outcomes may be influenced by RS. The multidimensional nature of RS and the complexity of related associations with different types of health relevant outcomes present formidable challenges to empirical study in behavioral medicine. These issues are referred to throughout our review and we suggest several solutions to the presented challenges in our summary. We end with a presentation of barriers to be overcome, along with strategies for doing so, and concluding thoughts.

Advancing our understanding of religion and spirituality in the context of behavioral medicine

PubMed Central

Masters, Kevin S.; Salsman, John M.; Wachholtz, Amy; Clements, Andrea D.; Salmoirago-Blotcher, Elena; Trevino, Kelly; Wischenka, Danielle M.

2016-01-01

Recognizing and understanding the potentially powerful roles that religiousness and spirituality (RS) may serve in the prevention and amelioration of disease, as well as symptom management and health related quality of life, significantly enhances research and clinical efforts across many areas of behavioral medicine. This article examines the knowledge established to date and suggests advances that remain to be made. We begin with a brief summary of the current knowledge regarding RS as related to three exemplary health conditions: (a) cardiovascular disease; (b) cancer; and, (c) substance abuse. We then focus on particular concerns for future investigations, emphasizing conceptual issues, possible mediators and moderators of relationships or effects, and methodology. Our discussion is framed by a conceptual model that may serve to guide and organize future investigations. This model highlights a number of important issues regarding the study of links between RS and health: (a) RS comprise many diverse constructs, (b) the mechanisms through which RS may influence health outcomes are quite diverse, and (c) a range of different types of health and health relevant outcomes may be influenced by RS. The multidimensional nature of RS and the complexity of related associations with different types of health relevant outcomes present formidable challenges to empirical study in behavioral medicine. These issues are referred to throughout our review and we suggest several solutions to the presented challenges in our summary. We end with a presentation of barriers to be overcome, along with strategies for doing so, and concluding thoughts. PMID:27342616

Connecting drug delivery reality to smart materials design.

PubMed

Grainger, David W

2013-09-15

Inflated claims to both design and mechanistic novelty in drug delivery and imaging systems, including most nanotechnologies, are not supported by the generally poor translation of these systems to clinical efficacy. The "form begets function" design paradigm is seductive but perhaps over-simplistic in translation to pharmaceutical efficacy. Most innovations show few clinically important distinctions in their therapeutic benefits in relevant preclinical disease and delivery models, despite frequent claims to the contrary. Long-standing challenges in drug delivery issues must enlist more realistic, back-to-basics approaches to address fundamental materials properties in complex biological systems, preclinical test beds, and analytical methods to more reliably determine fundamental pharmaceutical figures of merit, including drug carrier purity and batch-batch variability, agent biodistribution, therapeutic index (safety), and efficacy. Copyright © 2013 Elsevier B.V. All rights reserved.

Sacubitril/Valsartan in Clinical Practice: A Report of 2 Cases.

PubMed

Cosentino, Eugenio

Following the results of the PARADIGM-HF trial, the European Society of Cardiology (ESC) guidelines recommend sacubitril/valsartan to replace ACE inhibitors in ambulatory patients with heart failure with reduced ejection fraction (HFrEF) who remain symptomatic despite optimal therapy and who fit trial criteria. However, the optimal use of sacubitril/valsartan in clinical practice needs further investigation. We report here the cases of 2 patients with HFrEH successfully treated with sacubitril/valsartan in our daily practice. Both subjects presented multiple comorbidities and received an implantable cardioverter defibrillator in primary prevention. In both patients, therapy with sacubitril/valsartan led to prompt (30 days) amelioration of heart function, with a corresponding decrease in NHYA class and without any relevant safety issue. © 2017 S. Karger AG, Basel.

Proteomic analysis of tissue samples in translational breast cancer research.

PubMed

Gromov, Pavel; Moreira, José M A; Gromova, Irina

2014-06-01

In the last decade, many proteomic technologies have been applied, with varying success, to the study of tissue samples of breast carcinoma for protein expression profiling in order to discover protein biomarkers/signatures suitable for: characterization and subtyping of tumors; early diagnosis, and both prognosis and prediction of outcome of chemotherapy. The purpose of this review is to critically appraise what has been achieved to date using proteomic technologies and to bring forward novel strategies - based on the analysis of clinically relevant samples - that promise to accelerate the translation of basic discoveries into the daily breast cancer clinical practice. In particular, we address major issues in experimental design by reviewing the strengths and weaknesses of current proteomic strategies in the context of the analysis of human breast tissue specimens.

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive and provide suggestions for additional research to further our knowledge and understanding of this topic. Copyright © 2012 Mosby, Inc. All rights reserved.

Rethinking the Clinically Based Thresholds of TransCelerate BioPharma for Risk-Based Monitoring.

PubMed

Zink, Richard C; Dmitrienko, Anastasia; Dmitrienko, Alex

2018-01-01

The quality of data from clinical trials has received a great deal of attention in recent years. Of central importance is the need to protect the well-being of study participants and maintain the integrity of final analysis results. However, traditional approaches to assess data quality have come under increased scrutiny as providing little benefit for the substantial cost. Numerous regulatory guidance documents and industry position papers have described risk-based approaches to identify quality and safety issues. In particular, the position paper of TransCelerate BioPharma recommends defining risk thresholds to assess safety and quality risks based on past clinical experience. This exercise can be extremely time-consuming, and the resulting thresholds may only be relevant to a particular therapeutic area, patient or clinical site population. In addition, predefined thresholds cannot account for safety or quality issues where the underlying rate of observing a particular problem may change over the course of a clinical trial, and often do not consider varying patient exposure. In this manuscript, we appropriate rules commonly utilized for funnel plots to define a traffic-light system for risk indicators based on statistical criteria that consider the duration of patient follow-up. Further, we describe how these methods can be adapted to assess changing risk over time. Finally, we illustrate numerous graphical approaches to summarize and communicate risk, and discuss hybrid clinical-statistical approaches to allow for the assessment of risk at sites with low patient enrollment. We illustrate the aforementioned methodologies for a clinical trial in patients with schizophrenia. Funnel plots are a flexible graphical technique that can form the basis for a risk-based strategy to assess data integrity, while considering site sample size, patient exposure, and changing risk across time.

Research training in integrative medicine: how can we make teaching and learning in research methods more sustainable and engaging?

PubMed

Witt, Claudia M; Withers, Shelly Rafferty

2013-01-01

The aim of this project was to identify strategies for increasing learner engagement and knowledge retention in clinical research training of complementary and integrative medicine (CIM) practitioners, and to offer a conceptual framework to address clinical research training for CIM practitioners. In a featured large-group discussion (15min presentation and 30min discussion), two questions (strategies that are recommended to overcome these barriers; relevant aspects for a framework for building sustainable knowledge) were put to the audience. The sample consisted of 43 participants at the International Congress of Educators in Complementary and Alternative Medicine, in Washington, DC, in October 2012. The featured discussion was moderated and detailed notes were taken. Notes were synthesized and discussed by both authors until consensus was reached. Based on the results from the featured discussion session and a focused literature search, a framework for building sustainable knowledge and skills in clinical research for CIM practitioners was developed. Participants' responses to the questions of engagement and sustainability included curricular structures, pedagogical strategies for instruction, the use of digital tools to extend the learning experience, the necessity to ground instruction firmly in the medical literature of the field, and the relevance of mentoring. Key considerations for building sustainable knowledge in clinical research for CIM practitioners are as follows: (1) prioritizing clinical research training, (2) issues of curriculum and pedagogy, (3) technology/digital tools, (4) administrative challenges, (5) supporting the formation of communities of practice, and (6) cultural perspectives of CIM practitioners. © 2013 Elsevier Inc. All rights reserved.

Context-based electronic health record: toward patient specific healthcare.

PubMed

Hsu, William; Taira, Ricky K; El-Saden, Suzie; Kangarloo, Hooshang; Bui, Alex A T

2012-03-01

Due to the increasingly data-intensive clinical environment, physicians now have unprecedented access to detailed clinical information from a multitude of sources. However, applying this information to guide medical decisions for a specific patient case remains challenging. One issue is related to presenting information to the practitioner: displaying a large (irrelevant) amount of information often leads to information overload. Next-generation interfaces for the electronic health record (EHR) should not only make patient data easily searchable and accessible, but also synthesize fragments of evidence documented in the entire record to understand the etiology of a disease and its clinical manifestation in individual patients. In this paper, we describe our efforts toward creating a context-based EHR, which employs biomedical ontologies and (graphical) disease models as sources of domain knowledge to identify relevant parts of the record to display. We hypothesize that knowledge (e.g., variables, relationships) from these sources can be used to standardize, annotate, and contextualize information from the patient record, improving access to relevant parts of the record and informing medical decision making. To achieve this goal, we describe a framework that aggregates and extracts findings and attributes from free-text clinical reports, maps findings to concepts in available knowledge sources, and generates a tailored presentation of the record based on the information needs of the user. We have implemented this framework in a system called Adaptive EHR, demonstrating its capabilities to present and synthesize information from neurooncology patients. This paper highlights the challenges and potential applications of leveraging disease models to improve the access, integration, and interpretation of clinical patient data. © 2012 IEEE

Ethical issues identified by obstetrics and gynecology learners through a novel ethics curriculum.

PubMed

Mejia, Rachel B; Shinkunas, Laura A; Ryan, Ginny L

2015-12-01

Obstetrics and gynecology (ob/gyn) is fraught with bioethical issues, the professional significance of which may vary based on clinical experience. Our objective was to utilize our novel ethics curriculum to identify ethics and professionalism issues highlighted by ob/gyn learners and to compare responses between learner levels to further inform curricular development. We introduced an integrated and dynamic ob/gyn ethics and professionalism curriculum and mixed methods analysis of 181 resulting written reflections (case observation and assessments) from third-year medical students and from first- to fourth-year ob/gyn residents. Content was compared by learner level using basic thematic analysis and summary statistics. Within the 7 major ethics and professionalism domains, learners wrote most frequently about miscellaneous ob/gyn issues such as periviability and abortion (22% of students, 20% of residents) and problematic treatment decisions (20% of students, 19% of residents) rather than professional duty, communication, justice, student-/resident-specific issues, or quality of care. The most commonly discussed ob/gyn area by both learner groups was obstetrics rather than gynecology, gynecologic oncology, or reproductive endocrinology and infertility, although residents were more likely to discuss obstetrics-related concerns than students (65% vs 48%; P = .04) and students wrote about gynecologic oncology-related concerns more frequently than residents (25% vs 6%; P = .002). In their reflections, sources of ethical value (eg, the 4 classic ethics principles, professional guidelines, and consequentialism) were cited more frequently and in greater number by students than by residents (82% of students cited at least 1 source of ethical value vs 65% of residents; P = .01). Residents disagreed more frequently with the ethical propriety of clinical management than did students (67% vs 43%; P = .005). Our study introduces an innovative and dynamic approach to an ob/gyn ethics and professionalism curriculum that highlights important learner-identified ethics and professionalism issues both specific to ob/gyn and common to clinical medicine. Findings will help ob/gyn educators best utilize and refine this flexible curriculum such that it is appropriately focused on topics relevant to each learner level. Copyright © 2015 Elsevier Inc. All rights reserved.

Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture

PubMed Central

2014-01-01

Background Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Discussion Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients. There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Summary Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner. PMID:24495473

Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture.

PubMed

Masaki, Sakiko; Ishimoto, Hiroko; Asai, Atsushi

2014-02-04

Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient's best interest, and doing no harm in decision-making for patients.There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner.

Using Concept Mapping to Develop a Conceptual Framework for Creating Virtual Communities of Practice to Translate Cancer Research into Practice

PubMed Central

2014-01-01

Introduction Translating government-funded cancer research into clinical practice can be accomplished via virtual communities of practice that include key players in the process: researchers, health care practitioners, and intermediaries. This study, conducted from November 2012 through January 2013, examined issues that key stakeholders believed should be addressed to create and sustain government-sponsored virtual communities of practice to integrate cancer control research, practice, and policy and demonstrates how concept mapping can be used to present relevant issues. Methods Key stakeholders brainstormed statements describing what is needed to create and sustain virtual communities of practice for moving cancer control research into practice. Participants rated them on importance and feasibility, selected most relevant statements, and sorted them into clusters. I used concept mapping to examine the issues identified and multidimensional scaling analyses to create a 2-dimensional conceptual map of the statement clusters. Results Participants selected 70 statements and sorted them into 9 major clusters related to creating and sustaining virtual communities of practice: 1) standardization of best practices, 2) external validity, 3) funding and resources, 4) social learning and collaboration, 5) cooperation, 6) partnerships, 7) inclusiveness, 8) social determinants and cultural competency, and 9) preparing the environment. Researchers, health care practitioners, and intermediaries were in relative agreement regarding issues of importance for creating these communities. Conclusion Virtual communities of practice can be created to address the needs of researchers, health care practitioners, and intermediaries by using input from these key stakeholders. Increasing linkages between these subgroups can improve the translation of research into practice. Similarities and differences between groups can provide valuable information to assist the government in developing virtual communities of practice. PMID:24762532

Using concept mapping to develop a conceptual framework for creating virtual communities of practice to translate cancer research into practice.

PubMed

Vinson, Cynthia A

2014-04-24

Translating government-funded cancer research into clinical practice can be accomplished via virtual communities of practice that include key players in the process: researchers, health care practitioners, and intermediaries. This study, conducted from November 2012 through January 2013, examined issues that key stakeholders believed should be addressed to create and sustain government-sponsored virtual communities of practice to integrate cancer control research, practice, and policy and demonstrates how concept mapping can be used to present relevant issues. Key stakeholders brainstormed statements describing what is needed to create and sustain virtual communities of practice for moving cancer control research into practice. Participants rated them on importance and feasibility, selected most relevant statements, and sorted them into clusters. I used concept mapping to examine the issues identified and multidimensional scaling analyses to create a 2-dimensional conceptual map of the statement clusters. Participants selected 70 statements and sorted them into 9 major clusters related to creating and sustaining virtual communities of practice: 1) standardization of best practices, 2) external validity, 3) funding and resources, 4) social learning and collaboration, 5) cooperation, 6) partnerships, 7) inclusiveness, 8) social determinants and cultural competency, and 9) preparing the environment. Researchers, health care practitioners, and intermediaries were in relative agreement regarding issues of importance for creating these communities. Virtual communities of practice can be created to address the needs of researchers, health care practitioners, and intermediaries by using input from these key stakeholders. Increasing linkages between these subgroups can improve the translation of research into practice. Similarities and differences between groups can provide valuable information to assist the government in developing virtual communities of practice.

Patient-centered care: the key to cultural competence.

PubMed

Epner, D E; Baile, W F

2012-04-01

Much of the early literature on 'cultural competence' focuses on the 'categorical' or 'multicultural' approach, in which providers learn relevant attitudes, values, beliefs, and behaviors of certain cultural groups. In essence, this involves learning key 'dos and don'ts' for each group. Literature and educational materials of this kind focus on broad ethnic, racial, religious, or national groups, such as 'African American', 'Hispanic', or 'Asian'. The problem with this categorical or 'list of traits' approach to clinical cultural competence is that culture is multidimensional and dynamic. Culture comprises multiple variables, affecting all aspects of experience. Cultural processes frequently differ within the same ethnic or social group because of differences in age cohort, gender, political association, class, religion, ethnicity, and even personality. Culture is therefore a very elusive and nebulous concept, like art. The multicultural approach to cultural competence results in stereotypical thinking rather than clinical competence. A newer, cross cultural approach to culturally competent clinical practice focuses on foundational communication skills, awareness of cross-cutting cultural and social issues, and health beliefs that are present in all cultures. We can think of these as universal human beliefs, needs, and traits. This patient centered approach relies on identifying and negotiating different styles of communication, decision-making preferences, roles of family, sexual and gender issues, and issues of mistrust, prejudice, and racism, among other factors. In the current paper, we describe 'cultural' challenges that arise in the care of four patients from disparate cultures, each of whom has advanced colon cancer that is no longer responding to chemotherapy. We then illustrate how to apply principles of patient centered care to these challenges.

Monitoring ethical, legal, and social issues in developing population genetic databases.

PubMed

Austin, Melissa A; Harding, Sarah E; McElroy, Courtney E

2003-01-01

To characterize ethical, legal, and social issues unique to population genetic database research and to determine the relevance of international recommendations and guidelines for addressing these issues in the development of "genebank" projects globally. Building on our previous description of eight international genebanks, we conducted a comprehensive electronic search and literature review of relevant publications and consulted national and international documents applicable to genebank research. We identified and characterized five categories of ethical, legal, and social issues unique to genebank development: sponsorship and benefit-sharing, neutrality and regulatory power of ethics committees, public engagement, consent, and data protection. We illustrate these issues with examples from specific genebanks. Not all of the issues are addressed in current international guidelines, many of which are nonspecific and unenforceable. The trend of genebank development promises to provide new discoveries to the field of medical science and to greatly improve public health. However, there is a growing need for more explicit, enforceable, and coordinated international guidelines relevant to the development and implementation of genebanks. By comparing ethical, legal and social issues as they arise in genebanks, researchers can better evaluate how to best use these projects to improve public health while protecting participating populations.

Preventing plane-assisted suicides through the lessons of research on homicide and suicide-homicide.

PubMed

Rice, Timothy R; Sher, Leo

2016-08-01

The Germanwings 9525 incident drew significant attention to the 'plane-assisted suicide' construct, yet little scientific literature exists on this topic. This paper reviews the available literature and applies lessons from the suicide-homicide and men's mental health literature to better understand this construct from a scientific perspective. A systematic review of the relevant clinical literature was undertaken. Multiple lines of evidence suggests the applicability and relevance of suicide-homicide research and men's mental health to the plane-assisted suicide phenomenon. Plane-assisted suicides occur within an overwhelmingly male, middle aged population who, in addition to suicide, commit large scale acts of murder. Issues of divorce, separation, and threats to masculinity appear integral to an effective prevention program. Further research in the understanding of plane-assisted suicide as a product of neuropsychiatric disorder may advance such prevention efforts and have the opportunity to reduce the loss of life in future tragedies.

[Definition of low threshold volumes for quality assurance: conceptual and methodological issues involved in the definition and evaluation of thresholds for volume outcome relations in clinical care].

PubMed

Wetzel, Hermann

2006-01-01

In a large number of mostly retrospective association studies, a statistical relationship between volume and quality of health care has been reported. However, the relevance of these results is frequently limited by methodological shortcomings. In this article, criteria for the evidence and definition of thresholds for volume-outcome relations are proposed, e.g. the specification of relevant outcomes for quality indicators, analysis of volume as a continuous variable with an adequate case-mix and risk adjustment, accounting for cluster effects and considering mathematical models for the derivation of cut-off values. Moreover, volume thresholds are regarded as surrogate parameters for the indirect classification of the quality of care, whose diagnostic validity and effectiveness in improving health care quality need to be evaluated in prospective studies.

Ethical issues with informed consent from potential living kidney donors.

PubMed

Petrini, C

2010-05-01

Living organ donation and participation in clinical research trials have several features in common from an ethical perspective. The primary similarity is risk justification: the risk of harm to living organ donors and clinical research participants is justified by a resulting benefit to one or more other individuals. Some authors hold that organ donation and clinical trial participation are full-fledged duties. Such an implicit likening of the two leads to several considerations regarding informed consent in each situation. Informed consent raises ethical concerns in every medical context, and some of those concerns, such as competence, understanding, autonomy, and free or voluntary choice, are uniquely relevant to living organ donation and clinical trial participation. Most countries regulate informed consent procedures for living organ donation in great detail, and although informed consent procedures for clinical trial participation are somewhat less detailed, their rules are subject to review by ethics committees. It would be constructive for research participation informed consent procedures and living organ donation informed consent procedures to learn from one another. Copyright (c) 2009 Elsevier Inc. All rights reserved.

[The future of clinical research: why do we need an ecological approach?].

PubMed

Liberati, Alessandro; Moja, Lorenzo P; Moschetti, Ivan

2006-11-01

In this paper we try to define the future goals of the clinical research, with particular reference to methodological and policy issues. There is an increasing tension between the real drivers of clinical research and its scientific and ethical aims. To consumers the goal is to strengthen the relevance and usefulness of clinical research. This is possible only if consumers are empowered and actively involved. For the health care systems it is mandatory to re-engineer the process, enforcing national and international legislation. This should help to fill the research-clinical practice gap and to balance the research agenda, better reflecting health priorities. Finally the scientific community should reflect on its own conflicts of interests and analyse the causes of the ethical divide between the needs and the market. Scientists too often seem to loose sight of the original cumulative nature of research and of the idea of research as a collective good. More non-commercial research is needed, integrated with the health care systems, to support a transparent, more realistic and valid information useful for patient care, scientific information.

MRI-powered biomedical devices.

PubMed

Hovet, Sierra; Ren, Hongliang; Xu, Sheng; Wood, Bradford; Tokuda, Junichi; Tse, Zion Tsz Ho

2017-11-16

Magnetic resonance imaging (MRI) is beneficial for imaging-guided procedures because it provides higher resolution images and better soft tissue contrast than computed tomography (CT), ultrasound, and X-ray. MRI can be used to streamline diagnostics and treatment because it does not require patients to be repositioned between scans of different areas of the body. It is even possible to use MRI to visualize, power, and control medical devices inside the human body to access remote locations and perform minimally invasive procedures. Therefore, MR conditional medical devices have the potential to improve a wide variety of medical procedures; this potential is explored in terms of practical considerations pertaining to clinical applications and the MRI environment. Recent advancements in this field are introduced with a review of clinically relevant research in the areas of interventional tools, endovascular microbots, and closed-loop controlled MRI robots. Challenges related to technology and clinical feasibility are discussed, including MRI based propulsion and control, navigation of medical devices through the human body, clinical adoptability, and regulatory issues. The development of MRI-powered medical devices is an emerging field, but the potential clinical impact of these devices is promising.

Pathology consultation on anticoagulation monitoring: factor X-related assays.

PubMed

Wool, Geoffrey D; Lu, Chuanyi M

2013-11-01

To review various anticoagulation therapies and related laboratory monitoring issues, with a focus on factor X-related chromogenic assays. A case-based approach is used to review pertinent published literatures and product inserts of anticoagulation drugs and to look back on clinical use of factor X-related chromogenic assays. The number of anticoagulants available to clinicians has increased greatly in the past decade. Whether and how these anticoagulants should be monitored are areas of uncertainty for clinicians, which can lead to misuse of laboratory assays and suboptimal patient management. Factor X-related assays are of particular concern because of the similar and often confusing test names. Based on a common clinical case scenario and literature review regarding anticoagulant monitoring, an up-to-date discussion and review of the various factor X-related assays are provided, focusing on the differences in test designs and clinical utilities between the chromogenic anti-Xa and chromogenic factor X activity assays. Anticoagulation therapy and related laboratory monitoring are rapidly evolving areas of clinical practices. A good knowledge of relevant laboratory assays and their clinical applications is necessary to help optimize patient care.

Stalking behavior in delusional jealousy.

PubMed

Silva, J A; Derecho, D V; Leong, G B; Ferrari, M M

2000-01-01

Stalking behavior has been associated with several mental disorders, both psychotic and non-psychotic. The most frequently associated condition appears to be an individual with primitive personality psychopathology regardless of co-occurring psychotic symptomatology. Among the psychotic symptoms, erotomanic, and jealousy delusions may be the most clinically and torensically relevant. However, delusional jealousy has not been well appreciated in the psychiatric literature as an important contributor to stalking behavior. In this article, we explore the psychiatric, psychosocial, and forensic aspects of stalking in the context of delusional jealousy. We use a case example to highlight important issues in this area.

[Highlights of hospital-based internal medicine in 2010: chief residents' perspective].

PubMed

Uhlmann, Marc; Burnard, Jérôme; Cosma Rochat, Monica; Gabus, Vincent; Micheloud, Valérie Geiser; Gobin, Niels; Laurent, Jean-Christophe; Marino, Laura; Méan, Marie; Merz, Laurent; Regamey, Julien; Stadelmann, Raphaël

2011-02-02

Applying knowledge acquired from recent medical studies to patient care poses a daily challenge to physicians. Chief residents from the Department of Internal Medicine at the University Hospital of Lausanne carried out a review of some of the issues they considered important. The conclusions of these various publications may have a significant impact on the daily practice of hospital-based internal medicine. Modern medicine based on scientific studies is a reminder that in spite of the essential importance of clinical experience, it is crucial to confront it with the results of relevant publications from the medical literature.

Resources for Social Change II: A Guide for School Administrators.

ERIC Educational Resources Information Center

Wittes, Simon; And Others

This manual provides analyses of issues on and examples of programs relevant to contemporary school crises. Five authors comment on (1) the administrator's dilemma in school disruptions; (2) a case study of school disruption and the responses of two school administrators; (3) three major clusters of issues relevant to the state of American…

Dental students' motivation and the context of learning.

PubMed

Kristensen, Bettina Tjagvad; Netterstrom, Ingeborg; Kayser, Lars

2009-02-01

This qualitative study shows dental students' motives for choosing the dental education and how the motives influence their motivation at the first semester of study. Further the study demonstrates the relevance of the context of learning. This issue is of importance when planning a curriculum for the dental education. The material consists of interviews with eight dental students. The results show that dental students were focused on their future professional role, its practical dimensions and their future working conditions. Their motivation for choosing the dental education was found to influence their motivation for studying and their experience of the relevance of the first semester. The dental students who had co-education with the medical students at the first year of study missed a dental context and courses with clinically relevant contents. In conclusion, our data signify the importance of the context of learning. It is recommended that a future curriculum for the dental school should be designed in a way where basic science subjects are taught with both theoretically as well as practically oriented subjects and in a context which is meaningful for the students.

The Quest for Evidence for Proton Therapy: Model-Based Approach and Precision Medicine

DOE Office of Scientific and Technical Information (OSTI.GOV)

Widder, Joachim, E-mail: j.widder@umcg.nl; Schaaf, Arjen van der; Lambin, Philippe

Purpose: Reducing dose to normal tissues is the advantage of protons versus photons. We aimed to describe a method for translating this reduction into a clinically relevant benefit. Methods and Materials: Dutch scientific and health care governance bodies have recently issued landmark reports regarding generation of relevant evidence for new technologies in health care including proton therapy. An approach based on normal tissue complication probability (NTCP) models has been adopted to select patients who are most likely to experience fewer (serious) adverse events achievable by state-of-the-art proton treatment. Results: By analogy with biologically targeted therapies, the technology needs to be testedmore » in enriched cohorts of patients exhibiting the decisive predictive marker: difference in normal tissue dosimetric signatures between proton and photon treatment plans. Expected clinical benefit is then estimated by virtue of multifactorial NTCP models. In this sense, high-tech radiation therapy falls under precision medicine. As a consequence, randomizing nonenriched populations between photons and protons is predictably inefficient and likely to produce confusing results. Conclusions: Validating NTCP models in appropriately composed cohorts treated with protons should be the primary research agenda leading to urgently needed evidence for proton therapy.« less

Epidemiological characteristics of infectious hematopoietic necrosis virus (IHNV): a review.

PubMed

Dixon, Peter; Paley, Richard; Alegria-Moran, Raul; Oidtmann, Birgit

2016-06-10

Infectious hematopoietic necrosis virus (IHNV, Rhabdoviridae), is the causative agent of infectious hematopoietic necrosis (IHN), a disease notifiable to the World Organisation for Animal Health, and various countries and trading areas (including the European Union). IHNV is an economically important pathogen causing clinical disease and mortalities in a wide variety of salmonid species, including the main salmonid species produced in aquaculture, Atlantic salmon (Salmo salar) and rainbow trout (Oncorhynchus mykiss). We reviewed the scientific literature on IHNV on a range of topics, including geographic distribution; host range; conditions required for infection and clinical disease; minimum infectious dose; subclinical infection; shedding of virus by infected fish; transmission via eggs; diagnostic tests; pathogen load and survival of IHNV in host tissues. This information is required for a range of purposes including import risk assessments; parameterisation of disease models; for surveillance planning; and evaluation of the chances of eradication of the pathogen to name just a few. The review focuses on issues that are of relevance for the European context, but many of the data summarised have relevance to IHN globally. Examples for application of the information is presented and data gaps highlighted.

Using the Situated Clinical Decision-Making framework to guide analysis of nurses' clinical decision-making.

PubMed

Gillespie, Mary

2010-11-01

Nurses' clinical decision-making is a complex process that holds potential to influence the quality of care provided and patient outcomes. The evolution of nurses' decision-making that occurs with experience has been well documented. In addition, literature includes numerous strategies and approaches purported to support development of nurses' clinical decision-making. There has been, however, significantly less attention given to the process of assessing nurses' clinical decision-making and novice clinical educators are often challenged with knowing how to best support nurses and nursing students in developing their clinical decision-making capacity. The Situated Clinical Decision-Making framework is presented for use by clinical educators: it provides a structured approach to analyzing nursing students' and novice nurses' decision-making in clinical nursing practice, assists educators in identifying specific issues within nurses' clinical decision-making, and guides selection of relevant strategies to support development of clinical decision-making. A series of questions is offered as a guide for clinical educators when assessing nurses' clinical decision-making. The discussion presents key considerations related to analysis of various decision-making components, including common sources of challenge and errors that may occur within nurses' clinical decision-making. An exemplar illustrates use of the framework and guiding questions. Implications of this approach for selection of strategies that support development of clinical decision-making are highlighted. Copyright © 2010 Elsevier Ltd. All rights reserved.

Depression in medical students: current insights.

PubMed

Moir, Fiona; Yielder, Jill; Sanson, Jasmine; Chen, Yan

2018-01-01

Medical students are exposed to multiple factors during their academic and clinical study that have been shown to contribute to high levels of depression, anxiety, and stress. The purpose of this article was to explore the issue of depression in the medical student population, including prevalence, causes, and key issues, along with suggestions for early identification and support from one medical school in New Zealand. After establishing that the prevalence of depression is higher for medical students than the general population, the key issues explored include assessment used in the program, characteristics of the student population (such as Type A personality and perfectionism), resilience, selection procedures, students' motivation, and the nature of the clinical environment. This review includes several recommendations to improve students' psychological health such as positioning well-being within an overarching comprehensive workplace wellness model and integrating peer and faculty-led support into the day-to-day running of the institution. It also highlights the advantages of the addition of a well-being curriculum, as skills to prevent and manage distress and depression are relevant in supporting the competencies required by medical practitioners. It concludes that medical schools need wide-ranging strategies to address the complexities associated with the particular student population attracted to medicine and calls for educators to act, by noticing opportunities where they can introduce such initiatives into their medical programs.

Depression in medical students: current insights

PubMed Central

Moir, Fiona; Yielder, Jill; Sanson, Jasmine; Chen, Yan

2018-01-01

Medical students are exposed to multiple factors during their academic and clinical study that have been shown to contribute to high levels of depression, anxiety, and stress. The purpose of this article was to explore the issue of depression in the medical student population, including prevalence, causes, and key issues, along with suggestions for early identification and support from one medical school in New Zealand. After establishing that the prevalence of depression is higher for medical students than the general population, the key issues explored include assessment used in the program, characteristics of the student population (such as Type A personality and perfectionism), resilience, selection procedures, students’ motivation, and the nature of the clinical environment. This review includes several recommendations to improve students’ psychological health such as positioning well-being within an overarching comprehensive workplace wellness model and integrating peer and faculty-led support into the day-to-day running of the institution. It also highlights the advantages of the addition of a well-being curriculum, as skills to prevent and manage distress and depression are relevant in supporting the competencies required by medical practitioners. It concludes that medical schools need wide-ranging strategies to address the complexities associated with the particular student population attracted to medicine and calls for educators to act, by noticing opportunities where they can introduce such initiatives into their medical programs. PMID:29765261

Updating the OMERACT filter: core areas as a basis for defining core outcome sets.

PubMed

Kirwan, John R; Boers, Maarten; Hewlett, Sarah; Beaton, Dorcas; Bingham, Clifton O; Choy, Ernest; Conaghan, Philip G; D'Agostino, Maria-Antonietta; Dougados, Maxime; Furst, Daniel E; Guillemin, Francis; Gossec, Laure; van der Heijde, Désirée M; Kloppenburg, Margreet; Kvien, Tore K; Landewé, Robert B M; Mackie, Sarah L; Matteson, Eric L; Mease, Philip J; Merkel, Peter A; Ostergaard, Mikkel; Saketkoo, Lesley Ann; Simon, Lee; Singh, Jasvinder A; Strand, Vibeke; Tugwell, Peter

2014-05-01

The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter presupposes an explicit framework for identifying the relevant core outcomes that are universal to all studies of the effects of intervention effects. There is no published outline for instrument choice or development that is aimed at measuring outcome, was derived from broad consensus over its underlying philosophy, or includes a structured and documented critique. Therefore, a new proposal for defining core areas of measurement ("Filter 2.0 Core Areas of Measurement") was presented at OMERACT 11 to explore areas of consensus and to consider whether already endorsed core outcome sets fit into this newly proposed framework. Discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed framework, whether these observations had a more general application, and what issues remained to be resolved. Although there was broad acceptance of the framework in general, several important areas of construction, presentation, and clarity of the framework were questioned. The discussion groups and subsequent feedback highlighted 20 such issues. These issues will require resolution to reach consensus on accepting the proposed Filter 2.0 framework of Core Areas as the basis for the selection of Core Outcome Domains and hence appropriate Core Outcome Sets for clinical trials.

Hospital Malnutrition Related to Fasting and Underfeeding: Is It an Ethical Issue?

PubMed

Arenas Moya, Diego; Plascencia Gaitán, Alejandra; Ornelas Camacho, Denisse; Arenas Márquez, Humberto

2016-06-01

Hospital malnutrition is a relevant clinical issue present in about 50% of patients that is associated with increased morbidity, mortality, and cost of care. Because of the relation of malnutrition with chronic and acute inflammatory processes secondary to disease, nutrition therapy is considered an important medical treatment. However, there is little discussion about the impact of another critical issue related to hospital malnutrition, that is, lack of appropriate food or nutrition therapy given to the patients. Unnecessary fasting practices and the use of inappropriate nutrition prescriptions result in underfeeding that can be a related or direct cause of hospital malnutrition, independent of disease or inflammatory state. Suboptimal prescription of oral, enteral, and parenteral nutrition should be analyzed and discussed from an ethical perspective since this practice has the potential to harm patients. In addition, absence or inadequate provision of nutrition may present barriers for improved patient outcomes and could be prevented by simply recognizing lack of knowledge, skills, or experience in nutrition and entrusting nutrition prescription to interdisciplinary teams with clinicians well prepared in nutrition sciences. This article reviews potential barriers to the prevention or treatment of hospital malnutrition and proposes specific actions that can help clinicians to overcome and implement optimal nutrition not just as medical therapy but also as a basic comfort care that may help patients nutritionally, clinically, physically, and emotionally. © 2016 American Society for Parenteral and Enteral Nutrition.

Assessing cancer drugs for reimbursement: methodology, relationship between effect size and medical need.

PubMed

de Sahb-Berkovitch, Rima; Woronoff-Lemsi, Marie-Christine; Molimard, Mathieu

2010-01-01

Reimbursement is assessed by the Transparency Commission from the Health Authority (HAS) using a medical benefit (SMR) score that gives access to reimbursement, an "improvement of medical service rendered" (ASMR) that determines the added therapeutic value, and the target population. Assessing cancer drugs for reimbursement raises the same issues as other therapeutic classes, with some key differences. Overall survival (OS) is considered by the Transparency Commission as the endpoint for assessing clinical benefit, and yet it is not an applicable primary endpoint in all types of cancer. Later lines of treatment, particularly during the development process, may make it difficult to interpret OS as the primary endpoint. Therefore, progression-free survival (PFS) for metastatic situations and disease-free survival (DFS) in adjuvant situations are wholly relevant endpoints for decisions on the reimbursement of a new cancer drug. Effect size is assessed using actuarial survival curves of the product versus the comparator, and it is difficult to summarise them into one single parameter. Results are generally interpreted based on median survival, which is fragmented because it only measures one point of the curve. The hazard ratio measures the effect of treatment throughout the duration of survival and is therefore more comprehensive in quantifying clinical benefit. Determining an effect size threshold for granting reimbursement is difficult given the diversity of cancer settings and the level of medical need, which influences assessment of the clinical relevance of the observed difference. Rapid progress in comparators (700 molecules in development) and the identification of predictive factors of efficacy (biomarkers, histology, etc.) during development may lead to different ASMR scores per population, or to the restriction of the target population to a subgroup of the marketing authorisation (MA) population in which the expected effect size is greater. To address these issues, the roundtable recommends the possibility of early scientific opinions by the office of the Transparency Commission in order to discuss comparators and the relevance of responder subgroups. It also recommends the possibility of granting a temporary ASMR, on condition of subsequent confirmation by production of data, when reimbursement appears justified in a subpopulation of the MA for which only subgroup analysis is available. © 2010 Société Française de Pharmacologie et de Thérapeutique.

Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects.

PubMed

Hausner, Helene; Derving Karsbøl, Julie; Holst, Anders G; Jacobsen, Jacob B; Wagner, Frank-Dietrich; Golor, Georg; Anderson, Thomas W

2017-11-01

Semaglutide is a glucagon-like peptide-1 analogue in development for the once-weekly treatment of type 2 diabetes mellitus. Its effect on the rate and extent of absorption of concomitant oral medications (metformin, warfarin, atorvastatin and digoxin) was evaluated in healthy subjects. Subjects received metformin (500 mg twice daily for 3.5 days), warfarin (25 mg, single dose), atorvastatin (40 mg, single dose) or digoxin (0.5 mg, single dose) before and with subcutaneous semaglutide treatment at steady state (1.0 mg). Lack of drug-drug interaction was concluded if the 90% confidence intervals for the area under the plasma concentration-time curve ratio before and with semaglutide were within a pre-specified interval (0.80-1.25). Overall, metformin, warfarin, atorvastatin and digoxin pharmacokinetics were not affected to a clinically relevant degree with semaglutide co-administration. Estimated area under the plasma concentration-time curve ratios for all concomitant medications before and with semaglutide treatment were within the pre-specified interval. In addition, semaglutide did not affect maximum plasma concentration of concomitant medications to a relevant degree. Furthermore, no clinically relevant change in international normalised ratio response to warfarin was observed with semaglutide co-administration. Most adverse events with semaglutide treatment were mild or moderate. Adverse events with semaglutide and co-administered medication were comparable to those reported during treatment with semaglutide alone, and were mostly gastrointestinal related. No clinically significant pharmacokinetic or pharmacodynamic interactions were identified and no new safety issues observed with combined treatment with semaglutide. This suggests that no dose adjustments should be required when semaglutide is administered concomitantly with these medications.

Successful nonoperative treatment of a three-column thoracic fracture in a patient with ankylosing spondylitis: existence and clinical significance of the fourth column of the spine.

PubMed

Shen, Francis H; Samartzis, Dino

2007-07-01

A case report. To report the successful nonoperative management of a patient with progressive ankylosing spondylitis who sustained a three-column flexion-distraction injury of the upper thoracic spine with an intact sternal-rib complex, thereby emphasizing the existence and clinical relevance of the fourth-column concept in such patients. Three-column injuries of the cervical and lumbar spine are typically unstable and require surgical stabilization. Patients with ankylosing spondylitis are at an increase risk to sustain three-column injuries of the spine due to their progressive inflammatory disease, a state that renders the spine brittle and alters its biomechanical function. A fourth-column model of the thoracic spine has been proposed and incorporates the sternal-rib complex; however, such a model has rarely been addressed in the literature and its role regarding three-column upper thoracic spine injury with an intact sternal-rib complex in patients with ankylosing spondylitis is unknown. METHODS.: A 68-year-old white man with ankylosing spondylitis and Pickwickian body habitus sustained a three-column flexion-distraction injury at T5 following a ground-level fall. The patient complained of midthoracic back pain; however, he was neurologically intact and ambulated without aids. Because of the patient's numerous active medical issues that substantially increased his perioperative risks combined with symptomatic improvement of his pain, the patient refused surgical stabilization. In addition, because of the patient's body habitus and pulmonary issues, external brace immobilization was not tolerated. At 17 months of follow-up, the patient remained neurologically intact, ambulated well, his midthoracic back pain had subsided, and no progressive kyphosis was noted. This case confirms the existence and clinical relevance of the fourth column of the thoracic spine and its role in providing added spinal stability in the patient with ankylosing spondylitis. As such, it is still possible to achieve a favorable clinical outcome in a select subpopulation of patients with ankylosing spondylitis that sustain three-column flexion-distraction injuries who are neurologically intact and are not candidates for surgical stabilization.

Comparison of the cytotoxicity of clinically relevant cobalt-chromium and alumina ceramic wear particles in vitro.

PubMed

Germain, M A; Hatton, A; Williams, S; Matthews, J B; Stone, M H; Fisher, J; Ingham, E

2003-02-01

Concern over polyethylene wear particle induced aseptic loosening of metal-on-polyethylene hip prostheses has led to renewed interest in alternative materials such as metal-on-metal and alumina ceramic-on-alumina ceramic for total hip replacement. This study compared the effects of clinically relevant cobalt-chromium and alumina ceramic wear particles on the viability of U937 histiocytes and L929 fibroblasts in vitro. Clinically relevant cobalt-chromium wear particles were generated using a flat pin-on-plate tribometer. The mean size of the clinically relevant metal particles was 29.5+/-6.3 nm (range 5-200 nm). Clinically relevant alumina ceramic particles were generated in the Leeds MkII anatomical hip simulator from a Mittelmieier prosthesis using micro-separation motion. This produced particles with a bimodal size distribution. The majority (98%) of the clinically relevant alumina ceramic wear debris was 5-20 nm in size. The cytotoxicity of the clinically relevant wear particles was compared to commercially available cobalt-chromium (9.87 microm+/-5.67) and alumina ceramic (0.503+/-0.19 microm) particles. The effects of the particles on the cells over a 5 day period at different particle volume (microm(3)) to cell number ratios were tested and viability determined using ATP-Lite(TM). Clinically relevant cobalt-chromium particles 50 and 5 microm(3) per cell reduced the viability of U937 cells by 97% and 42% and reduced the viability of L929 cells by 95% and 73%, respectively. At 50 microm(3) per cell, the clinically relevant ceramic particles reduced U937 cell viability by 18%. None of the other concentrations of the clinically relevant particles were toxic. The commercial cobalt-chromium and alumina particles did not affect the viability of either the U937 histiocytes or the L929 fibroblasts.Thus at equivalent particle volumes the clinically relevant cobalt-chromium particles were more toxic then the alumina ceramic particles. This study has emphasised the fact that the nature, size and volume of particles are important in assessing biological effects of wear debris on cells in vitro.

[Concept and results of the German Research Network on Schizophrenia].

PubMed

Gaebel, W; Buchkremer, G; Häfner, H; Klosterkötter, J; Maier, W; Möller, H-J; Wölwer, W

2016-04-01

The German Research Network on Schizophrenia (GRNS) was funded by the Federal Ministry of Education and Research (BMBF) from 1999 to 2011. The aim was to obtain a better horizontal and vertical networking of German research and care facilities on schizophrenia, in order to investigate open research questions, to transfer the results into clinical practice and improve care and quality of life in patients with schizophrenia. This paper describes the concept and operations of the GRNS as well as its results on the basis of selected research projects. The GRNS comprised about 25 clinical trials of high practical relevance, which were closely interrelated regarding content, methodology and organization. The trials primarily served the development and evaluation of new and established diagnostic and therapeutic approaches, the assessment of the status quo of clinical care, as well as its improvements, together with the investigation of basic scientific questions. Many substantial results to highly relevant issues were obtained, which led or will lead to an improvement in mental health care. Quantitative and qualitative evaluation parameters, such as scientific publications and obtaining additional grants, as well as promotion of young scientists, public relations activities, congress activities and the foundation of a European Schizophrenia Association, document the successful work of the network. Successful funding requests will allow us to continue cooperative schizophrenia research in Germany as initiated by the GRNS, without necessarily always binding these activities formally to the GRNS.

WOC practice in cyberspace: legal and ethical issues.

PubMed

Hoyman, K

2001-07-01

WOC nurses have the opportunity to extend their practice geographically by using electronic media, also called telehealth or "practicing in cyberspace." Currently, laws and regulations affecting this aspect of practice are in rapid flux. In addition, practicing electronically makes the ethical issues of choice, privacy, and confidentiality more acute. This article describes the current status of relevant legislation, discusses relevant ethical issues, and provides guidelines for WOC nurses who are considering the use of e-mail and video conferencing within their practice.

Defining and investigating social disparities in cancer: critical issues.

PubMed

Krieger, Nancy

2005-02-01

Research and action to address social disparities in cancer requires clarity about what constitutes and causes these persistent and onerous inequities in health. Currently, both scientific literature and government documents exhibit important disagreements, confused terminology, and considerable, if not deliberate, vagueness about the meaning of the phrase 'cancer disparities' and the related term 'social disparities in health.' This article accordingly reviews critical issues relevant to cohering understanding of what is meant by 'cancer disparities;' offers a definition premised on the causal contention that social disparities in health, by definition, arise from social inequity; and considers its implications for developing a multidisciplinary research agenda on social inequalities in cancer. Tackling this issue will require rigorous and critical frameworks, questions, and methods derived from multiple disciplines, and will necessarily involve epidemiologic, clinical, and intervention research, both quantitative and qualitative. At issue is making conscious research choices: about which types of disparities we study, in relation to which aspect of cancer, so as to improve the likelihood our research will help inform a society-wide discourse about the extent, origins of, and remedies for social injustices in cancer, thereby aiding efforts to eliminate social inequalities in health.

State of the Art of Interpersonal Physiology in Psychotherapy: A Systematic Review.

PubMed

Kleinbub, Johann R

2017-01-01

Introduction: The fast expanding field of Interpersonal Physiology (IP) focuses on the study of co-ordination or synchronization dynamics between the physiological activities of two, or more, individuals. IP has been associated with various relational features (e.g., empathy, attachment security, rapport, closeness…) that overlap with desirable characteristics of clinical relationships, suggesting that the relevant studies might provide objective, economical, and theory-free techniques to investigate the clinical process. The goal of the present work is to systematically retrieve and review the literature on IP in the field of psychotherapy and psychological intervention, in order to consolidate the knowledge of this research domain, highlight its critical issues, and delineate possible developments. Method: Following the guidelines by Okoli and Schabram (2010), a systematic literature search was performed in Scopus, Web of Science, PsycINFO, and PubMed databases by means of multiple keyword combinations; the results were integrated with references to the retrieved articles' bibliography as well as to other published reviews on IP. Results: All the retrieved documents reported clinical interactions that are characterized, at least partially, by IP phenomena. They appear to use fragmented and sometimes ambiguous terminology and show a lack of both specific theory-informed hypotheses and sound analytical procedures. Conclusion: Although the psychological nature of IP and its role in the clinical relationship are still mostly unknown, the potential value of a physiology-based measure of implicit exchanges in psychotherapy drives an acceleration in this research field. On the basis of the highlighted critical issues, possible future directions for clinical IP researchers are discussed.

Challenges in economic evaluation of new drugs: experience with rituximab in Hungary.

PubMed

Brodszky, Valentin; Orlewska, Ewa; Pentek, Martha; Karpati, Krisztian; Skoupa, Jana; Gulacsi, Laszlo

2010-01-01

Implementation of a new therapy into clinical practice is a complex process. Various countries have different requirements for information but most often focus on economic evaluation, which often plays a stronger role in healthcare decision making than does clinical evidence. To identify all potential challenges in economic evaluation, the case of a new biological drug, rituximab, used to treat rheumatoid arthritis, has been taken as an example. We present methods and results of economic assessment, highlighting the specific issues that should be considered in countries with economic and health care conditions similar to those of Hungary. In principle, economic evaluation requires data on characteristics of target population, disease progression, treatment impact, preferences, resource utilization and unit prices. Treatment effect/relative risk reduction and clinical practice patterns (resource use) may be more generalizable, whereas prices and baseline risk need to be jurisdiction specific. In order to address issues of transferability, investments need to be made in the collection of epidemiological and demographic data, plus data on clinical practice patterns, resource use, costs and health state valuation. In Hungary this problem has been solved through conducting a well designed 255 patient cross-sectional study. The Hungarian example shows that there should be more investment in data collection for those parameters that are thought to differ most from place to place. Owing to the similarities between Central and Eastern Europe countries in health care systems, clinical practice patterns and economic indicators, they may be able to develop partnerships to develop relevant regional databases and registries.

Clinical management issues vary by specialty in the Victorian Audit of Surgical Mortality: a retrospective observational study

PubMed Central

Vinluan, Jessele; Retegan, Claudia; Chen, Andrew; Beiles, Charles Barry

2014-01-01

Objective Clinical management issues are contributory factors to mortality. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM), an educational peer-review process for surgeons, to discover differences in the incidence of these issues between surgical specialties in order to focus attention to areas of care that might be improved. Design This study used retrospectively analysed observational data from VASM. Clinical management issues between eight specialties were assessed using χ2 analysis. Data sources VASM data were reported by participating public and private health services, the Coroner and self-reporting surgeons across Victoria. Results A total of 2946 specific clinical issues as deficiencies of care were reported. 15% of cases had significant issues of care. The most common clinical management issue was the delay in delivery of treatment. Other clinical issues included the quality of communication and documentation, preoperative and postoperative care, adverse events and protocol issues. There were significant differences in issues between specialties. Conclusions The clinical management issues presented across surgical specialties were similar; however, five issues of clinical care differed significantly in frequency across surgical specialties. The three main issues varying among specialties were complications after operation, communication and postoperative care. Addressing these clinical management issues via the peer-review process may impact positively on patient care. PMID:24980043

Genetic susceptibility testing for neurodegenerative diseases: Ethical and practice issues

PubMed Central

Roberts, J. Scott; Uhlmann, Wendy R.

2013-01-01

As the genetics of neurodegenerative disease become better understood, opportunities for genetic susceptibility testing for at-risk individuals will increase. Such testing raises important ethical and practice issues related to test access, informed consent, risk estimation and communication, return of results, and policies to prevent genetic discrimination. The advent of direct-to-consumer genetic susceptibility testing for various neurodegenerative disorders (including Alzheimer’s disease, Parkinson’s disease, and certain prion diseases) means that ethical and practical challenges must be faced not only in traditional research and clinical settings, but also in broader society. This review addresses several topics relevant to the development and implementation of genetic susceptibility tests across research, clinical, and consumer settings; these include appropriate indications for testing, the implications of different methods for disclosing test results, clinical versus personal utility of risk information, psychological and behavioral responses to test results, testing of minors, genetic discrimination, and ethical dilemmas posed by whole-genome sequencing. We also identify future areas of likely growth in the field, including pharmacogenomics and genetic screening for individuals considering or engaged in activities that pose elevated risk of brain injury (e.g., football players, military personnel). APOE gene testing for risk of Alzheimer’s disease is used throughout as an instructive case example, drawing upon the authors’ experience as investigators in a series of multisite randomized clinical trials that have examined the impact of disclosing APOE genotype status to interested individuals (e.g., first-degree relatives, persons with mild cognitive impairment). PMID:23583530

Mediation misgivings: ambiguous clinical and public health interpretations of natural direct and indirect effects.

PubMed

Naimi, Ashley I; Kaufman, Jay S; MacLehose, Richard F

2014-10-01

Recent methodological innovation is giving rise to an increasing number of applied papers in medical and epidemiological journals in which natural direct and indirect effects are estimated. However, there is a longstanding debate on whether such effects are relevant targets of inference in population health. In light of the repeated calls for a more pragmatic and consequential epidemiology, we review three issues often raised in this debate: (i) the use of composite cross-world counterfactuals and the need for cross-world independence assumptions; (ii) interventional vs non-interventional identifiability; and (iii) the interpretational ambiguity of natural direct and indirect effect estimates. We use potential outcomes notation and directed acyclic graphs to explain 'cross-world' assumptions, illustrate implications of this assumption via regression models and discuss ensuing issues of interpretation. We argue that the debate on the relevance of natural direct and indirect effects rests on whether one takes as a target of inference the mathematical object per se, or the change in the world that the mathematical object represents. We further note that public health questions may be better served by estimating controlled direct effects. © The Author 2014; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Psychosocial issues in children and adolescents with HIV infection evaluated with a World Health Organization age-specific descriptor system.

PubMed

Giannattasio, Antonietta; Officioso, Annunziata; Continisio, Grazia Isabella; Griso, Giovanna; Storace, Cinzia; Coppini, Simonetta; Longhi, Daniela; Mango, Carmela; Guarino, Alfredo; Badolato, Raffaele; Pisacane, Alfredo

2011-01-01

After active antiretroviral therapy, children with HIV are clinically well, whereas psychosocial issues continue to influence their quality of life. The International Classification of Functioning, Disability and Health (ICF) of the World Health Organization evaluates health status and environmental and social factors associated with health. We investigated the efficacy of the ICF to describe the health status and needs of a cohort of children and adolescents with HIV seen at a reference center for pediatric AIDS in Europe. A quantitative analysis of structured interviews was performed. Caregivers of children and adolescents with HIV infection in follow-up at 2 reference centers for pediatric AIDS were enrolled. Four major areas included in the ICF instrument were investigated: impairments of body structures; impairments of body functions; environmental factors; and activity limitations and restrictions to social life. Forty-one families of children with HIV were enrolled. Body structures and functions were marginally impaired, whereas environmental factors and psychosocial issues had a relevant impact on quality of life. Most families considered environmental factors to be "barriers"; these were poverty, unemployment, and single-parent family structure. Activity limitations and social restrictions were also reported in a few cases. Almost all parents reported problems in disclosing their child's HIV status because of the fear of social stigma. Psychosocial issues are part of the well-being of children with HIV. The ICF is a standard tool to evaluate the clinical and psychosocial status of children and adolescents with HIV infection and to measure the impact of therapeutic interventions and strategies on psychosocial functioning.

A Different Approach to Attitude Scale Construction.

ERIC Educational Resources Information Center

Edirisooriya, Gunapala

This paper suggests a new approach to attitude scale construction. Instead of asking respondents to express the extent or the degree of opinion on a particular issue, respondents should be asked about the factors that are relevant for the issue of interest and how much weight respondents are willing to attach to each relevant piece of evidence.…

Ethics support for GPs: what should it look like?

PubMed

Clark-Grill, Monika

2016-03-01

INTRODUCTION Ethics support services for hospital clinicians have become increasingly common globally but not as yet in New Zealand. However, an initiative to change this is gathering momentum. Its slogan 'Clinical ethics is everyone's business' indicates that the aim is to encompass all of health care, not just the hospital sector. General Practitioners (GPs) deal with ethical issues on a daily basis. These issues are often quite different from ethical issues in hospitals. To make future ethics support relevant for primary care, local GPs were interviewed to find out how they might envisage ethics support services that could be useful to them. METHODS A focus group interview with six GPs and semi-structured individual interviews with three GPs were conducted. Questions included how they made decisions on ethical issues at present, what they perceived as obstacles to ethical reflection and decision-making, and what support might be helpful. FINDINGS Three areas of ethics support were considered potentially useful: Formal ethics education during GP training, access to an ethicist for assistance with analysing an ethical issue, and professional guidance with structured ethics conversations in peer groups. CONCLUSION The complex nature of general practice requires GPs to be well educated and supported for handling ethical issues. The findings from this study could serve as input to the development of ethics support services. KEYWORDS General practice; primary care; ethics; support; education.

Guidelines for Guidelines: Are They Up to the Task? A Comparative Assessment of Clinical Practice Guideline Development Handbooks

PubMed Central

Ansari, Shabnam; Rashidian, Arash

2012-01-01

Objectives We conducted a comparative review of clinical practice guideline development handbooks. We aimed to identify the main guideline development tasks, assign weights to the importance of each task using expert opinions and identify the handbooks that provided a comprehensive coverage of the tasks. Methods We systematically searched and included handbooks published (in English language) by national, international or professional bodies responsible for evidenced-based guideline development. We reviewed the handbooks to identify the main guideline development tasks and scored each handbook for each task from 0 (the handbook did not mention the task) to 2 (the task suitably addressed and explained), and calculated a weighted score for each handbook. The tasks included in over 75% of the handbooks were considered as ‘necessary’ tasks. Result Nineteen guideline development handbooks and twenty seven main tasks were identified. The guideline handbooks’ weighted scores ranged from 100 to 220. Four handbooks scored over 80% of the maximum possible score, developed by the National Institute for Health and Clinical Excellence, Swiss Centre for International Health, Scottish Intercollegiate Guidelines Network and World Health Organization. Necessary tasks were: selecting the guideline topic, determining the guideline scope, identifying relevant existing guidelines, involving the consumers, forming guideline development group,, developing clinical questions, systematic search for evidence, selecting relevant evidence, appraising identifies research evidence, making group decision, grading available evidence, creating recommendations, final stakeholder consultation, guideline implementation strategies, updating recommendations and correcting potential errors. Discussion Adequate details for evidence based development of guidelines were still lacking from many handbooks. The tasks relevant to ethical issues and piloting were missing in most handbooks. The findings help decision makers in identifying the necessary tasks for guideline development, provide an updated comparative list of guideline development handbooks, and provide a checklist to assess the comprehensiveness of guideline development processes. PMID:23189167

'The trial is owned by the team, not by an individual': a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology.

PubMed

Strong, Sean; Paramasivan, Sangeetha; Mills, Nicola; Wilson, Caroline; Donovan, Jenny L; Blazeby, Jane M

2016-04-26

Challenges exist in recruitment to trials involving interventions delivered by different clinical specialties. Collaboration is required between clinical specialty and research teams. The aim of this study was to explore how teamwork influences recruitment to a multicentre randomised controlled trial (RCT) involving interventions delivered by different clinical specialties. Semi-structured interviews were conducted in three centres with a purposeful sample of members of the surgical, oncology and research teams recruiting to a feasibility RCT comparing definitive chemoradiotherapy with chemoradiotherapy and surgery for oesophageal squamous cell carcinoma. Interviews explored factors known to influence healthcare team effectiveness and were audio-recorded and thematically analysed. Sampling, data collection and analysis were undertaken iteratively and concurrently. Twenty-one interviews were conducted. Factors that influenced how team working impacted upon trial recruitment were centred on: (1) the multidisciplinary team (MDT) meeting, (2) leadership of the trial, and (3) the recruitment process. The weekly MDT meeting was reported as central to successful recruitment and formed the focus for creating a 'study team', bringing together clinical and research teams. Shared study leadership positively influenced healthcare professionals' willingness to participate. Interviewees perceived their clinical colleagues to have strong treatment preferences which led to scepticism regarding whether the treatments were being described to patients in a balanced manner. This study has highlighted a number of aspects of team functioning that are important for recruitment to RCTs that span different clinical specialties. Understanding these issues will aid the production of guidance on team-relevant issues that should be considered in trial management and the development of interventions that will facilitate teamwork and improve recruitment to these challenging RCTs. International Standard Randomised Controlled Trial Number (ISRCTN): ISRCTN89052791 .

Orthotic management of the neuropathic foot: an interdisciplinary care perspective.

PubMed

Robinson, Christopher; Major, Matthew J; Kuffel, Charles; Hines, Kevin; Cole, Pamela

2015-02-01

Clinical management of the patient with neuropathic foot is becoming commonplace in orthotic clinics worldwide. The presentations that can result from neuropathic foot are diverse, requiring clinicians to understand the pathomechanics of ulceration, infection, and Charcot joint arthropathy to provide effective interventions. The purpose of this clinical perspective is to provide a review of the literature regarding clinical concepts associated with orthotic management of neuropathic foot. Literature review and clinical case study. Relevant literature were reviewed and summarized, and a clinical case study synthesizing reviewed concepts was presented. Given the multifactorial nature of the neuropathic foot, treatments must be multifaceted and patient-specific to effectively address the underlying disease processes. While systemic issues such as peripheral arterial disease are treated by physicians, local issues such as foot deformity are managed by orthotists. Orthotic interventions commonly include custom footwear to reduce the risk of ulceration through creation of a protective environment or targeted plantar offloading. Patient and caregiver education to encourage management compliance is equally as important to ensure successful treatment. Patients with neuropathic foot benefit from an interdisciplinary care approach which engages physicians, wound care practitioners, and orthotists to treat and manage systemic and local problems. Addressing this pathology through interdisciplinary care may positively affect the patient's health status while lowering associated healthcare costs through improved treatment efficacy. The commonality of neuropathic foot and associated complications including ulceration, infection, and Charcot joint arthropathy requires that the patient care team have a fundamental understanding of these pathologies and common treatment modalities. We review orthotic treatment modalities to assist clinicians with the management of patients with neuropathic foot. © The International Society for Prosthetics and Orthotics 2014.

From one side to the other: what is essential? Perception of oncology patients and their caregivers in the beginning of oncology treatment and in palliative care

PubMed Central

Munhoz, Bruna Antenussi; Paiva, Henrique Soares; Abdalla, Beatrice Martinez Zugaib; Zaremba, Guilherme; Rodrigues, Andressa Macedo Paiva; Carretti, Mayra Ribeiro; Monteiro, Camila Ribeiro de Arruda; Zara, Aline; Silva, Jussara Oliveira; Assis, Widner Baptista; Auresco, Luciana Campi; Pereira, Leonardo Lopes; del Giglio, Adriana Braz; Lepori, Ana Claudia de Oliveira; Trufelli, Damila Cristina; del Giglio, Auro

2014-01-01

Objective To evaluate the perception of oncology patients and their caregivers upon diagnosis and beginning of the therapy and during palliative care. Methods A cross-sectional study at the oncology and palliative care outpatients clinics of the Faculdade de Medicina do ABC . Clinical and demographic data from patients and their caregivers were collected and questionnaires regarding the elements considered important in relation to the treatment were applied. Results We enrolled 32 patients and 23 caregivers that were initiating treatment at the oncology outpatient clinic, as well as 20 patients and 20 caregivers at the palliative care clinic. Regarding the patients treated at the oncology clinic, the issues considered most important were a physician available to discuss the disease and answer questions (84%), trust in the physician (81%), and a physician with accessible language (81%). For their caregivers, the following issues were considered extremely important: trust in the medical team that treats the patients (96%), and the same medical team taking care of their relatives (87%). As to patients treated at the palliative care clinic, trust in the physician (83%), to be with people considered important to them (78%), and to be treated preserving their dignity (72%) were considered extremely important. For their caregivers, to receive adequate information about the disease and the treatment’s risks and benefits (84%), and sincere communication of information about the disease (79%) were considered extremely relevant. Conclusion Confidence through good communication and consistency in care were fundamental values to achieve satisfaction among caregivers and patients with cancer during all the course of disease development. PMID:25628202

The no-observed-adverse-effect-level in drug safety evaluations: use, issues, and definition(s).

PubMed

Dorato, Michael A; Engelhardt, Jeffery A

2005-08-01

The no-observed-adverse-effect-level (NOAEL) is an important part of the non-clinical risk assessment. It is a professional opinion based on the design of the study, indication of the drug, expected pharmacology, and spectrum of off-target effects. There is no consistent standard definition of NOAEL. This is based, in part, on the varied definitions of what constitutes an adverse effect. Toxicologists, either investigating or reviewing, have not been consistent in defining an effect as either adverse or acceptable. The common definition of NOAEL, "the highest experimental point that is without adverse effect," serves us well in general discussions. It does not, however, address the interpretation of risk based on toxicologically relevant effects, nor does it consider the progression of effect with respect to duration and/or dose. This paper will discuss the issues and application of a functional definition of the NOAEL in toxicology evaluations.

Ethics of fetal tissue transplantation.

PubMed Central

Sanders, L M; Giudice, L; Raffin, T A

1993-01-01

Now that the Clinton Administration has overturned the ban on federal funding for fetal tissue transplantation, old ethical issues renew their relevance and new ethical issues arise. Is fetal tissue transplantation necessary and beneficial? Are fetal rights violated by the use of fetal tissue in research? Is there a moral danger that the potential of fetal tissue donation will encourage elective abortions? Should pregnant women be allowed to designate specific fetal transplant recipients? What criteria should be used to select fetal tissue transplants? Whose consent should be required for the use of fetal tissue for transplantation? We review the current state of clinical research with fetal tissue transplantation, the legal history of fetal tissue research, the major arguments against the use of fetal tissue for transplantation, and the new postmoratorium ethical dilemmas. We include recommendations for guidelines to govern the medical treatment of fetal tissue in transplantation. Images PMID:8236984

Sleep: Important Considerations for the Prevention of Cardiovascular Disease

PubMed Central

Grandner, Michael A.; Alfonso-Miller, Pamela; Fernandez-Mendoza, Julio; Shetty, Safal; Shenoy, Sundeep; Combs, Daniel

2016-01-01

Purpose of Review Sleep plays many roles in maintenance of cardiovascular health. This review summarizes the literature across several areas of sleep and sleep disorders in relation to cardiometabolic disease risk factors. Current Findings Insufficient sleep duration is prevalent in the population and is associated with weight gain and obesity, inflammation, cardiovascular disease, diabetes, and mortality. Insomnia is also highly present and represents an important risk factor for cardiovascular disease, especially when accompanied by short sleep duration. Sleep apnea is a well-characterized risk factor for cardiometabolic disease and cardiovascular mortality. Other issues are relevant as well. For example, sleep disorders in pediatric populations may convey cardiovascular risks. Also, sleep may play an important role in cardiovascular health disparities. Summary Sleep and sleep disorders are implicated in cardiometabolic disease risk. This review addresses these and other issues, concluding with recommendations for research and clinical practice. PMID:27467177

Return of research results from pharmacogenomic versus disease susceptibility studies: what’s drugs got to do with it?

PubMed Central

Dressler, Lynn G

2012-01-01

One of the most controversial ethical issues in genomics research is the return of individual research results to research subjects. As new technologies, including whole-genome sequencing, provide an increased opportunity for researchers to find clinically relevant research results, the questions related to if, when and how individual research results should be returned become more central to the ethical conduct of genomic research. In the absence of federal guidance on this issue, many groups and individuals have developed recommendations and suggestions to address these questions. Most of these recommendations have focused on the return of individual results from disease susceptibility studies. However, in addition to predicting the development of disease, genomic research also includes predicting an individual’s response to drugs, especially the risk of developing adverse events. This article evaluates and compares the return of individual research results from disease susceptibility studies versus pharmacogenomic studies. PMID:22676197

Vaccines and Kawasaki disease.

PubMed

Esposito, Susanna; Bianchini, Sonia; Dellepiane, Rosa Maria; Principi, Nicola

2016-01-01

The distinctive immune system characteristics of children with Kawasaki disease (KD) could suggest that they respond in a particular way to all antigenic stimulations, including those due to vaccines. Moreover, treatment of KD is mainly based on immunomodulatory therapy. These factors suggest that vaccines and KD may interact in several ways. These interactions could be of clinical relevance because KD is a disease of younger children who receive most of the vaccines recommended for infectious disease prevention. This paper shows that available evidence does not support an association between KD development and vaccine administration. Moreover, it highlights that administration of routine vaccines is mandatory even in children with KD and all efforts must be made to ensure the highest degree of protection against vaccine-preventable diseases for these patients. However, studies are needed to clarify currently unsolved issues, especially issues related to immunologic interference induced by intravenous immunoglobulin and biological drugs.

Ethical, Legal, Social, and Policy Implications of Behavioral Genetics

PubMed Central

Berryessa, Colleen M.; Cho, Mildred K.

2015-01-01

The field of behavioral genetics has engendered a host of moral and social concerns virtually since its inception. The policy implications of a genetic basis for behaviors are widespread and extend beyond the clinic to the socially important realms of education, criminal justice, childbearing, and child rearing. The development of new techniques and analytic approaches, including whole-genome sequencing, noninvasive prenatal genetic testing, and optogenetics, has clearly changed the study of behavioral genetics. However, the social context of biomedical research has also changed profoundly over the past few decades, and in ways that are especially relevant to behavioral genetics. The ever-widening scope of behavioral genetics raises ethical, legal, social, and policy issues in the potential new applications to criminal justice, education, the military, and reproduction. These issues are especially critical to address because of their potentially disproportionate effects on vulnerable populations such as children, the unborn, and the incarcerated. PMID:23452225

Return of research results from pharmacogenomic versus disease susceptibility studies: what's drugs got to do with it?

PubMed

Dressler, Lynn G

2012-06-01

One of the most controversial ethical issues in genomics research is the return of individual research results to research subjects. As new technologies, including whole-genome sequencing, provide an increased opportunity for researchers to find clinically relevant research results, the questions related to if, when and how individual research results should be returned become more central to the ethical conduct of genomic research. In the absence of federal guidance on this issue, many groups and individuals have developed recommendations and suggestions to address these questions. Most of these recommendations have focused on the return of individual results from disease susceptibility studies. However, in addition to predicting the development of disease, genomic research also includes predicting an individual's response to drugs, especially the risk of developing adverse events. This article evaluates and compares the return of individual research results from disease susceptibility studies versus pharmacogenomic studies.

The association between interpersonal problems and treatment outcome in the eating disorders: A systematic review.

PubMed

Jones, Allan; Lindekilde, Nanna; Lübeck, Marlene; Clausen, Loa

2015-01-01

To review systematically the eating disorder literature in order to examine the association between pre-treatment interpersonal problems and treatment outcome in people diagnosed with an eating disorder. Six relevant databases were searched for studies in which interpersonal problems prior to treatment were examined in relation to treatment outcome in patients diagnosed with anorexia nervosa (AN), bulimia nervosa (BN) or eating disorders not otherwise specified (EDNOS). Thirteen studies were identified (containing 764 AN, 707 BN and 48 EDNOS). The majority of studies indicated that interpersonal problems at the start of therapy were associated with a detrimental treatment outcome. Individuals with a binge/purge-type of eating disorder may be particularly vulnerable to interpersonal issues and these issues may lead to poorer treatment recovery by reducing the individual's ability to engage in the treatment process on a functional level. The clinical and research implications are discussed.

World Cup 2010 planning: an integration of public health and medical systems.

PubMed

Yancey, Arthur H; Fuhri, Peter D; Pillay, Yogan; Greenwald, Ian

2008-10-01

To present crucial stages of planning and the resources involved in the medical and health care that will address issues affecting the health and safety of all participants in the 2010 World Cup. Relevant literature reviews of mass gathering medical care supplemented experience of the authors in planning for previous similar events. Attention is focused on issues wherein effective planning requires the integration of public health practices with those of clinical emergency medical services. The tables that are included serve to illustrate the depth and breadth of planning as well as the organizational relationships required to execute care of a universally acceptable standard. This article offers guidance in planning for the 2010 World Cup health and emergency medical care, emphasizing the need for integration of public health and medical practices. It depicts the span of planning envisioned, the organizational relationships crucial to it, and emphasizes the necessity of an early start.

Leflunomide counter akt s cardiac hypertrophy.

PubMed

Pescatore, Luciana A; Laurindo, Francisco R M

2018-05-31

Cardiac hypertrophy (CH) is a major independent risk factor for heart failure and mortality. However, therapeutic interventions that target hypertrophy signaling in a load-independent way are unavailable. In a recent issue of Clinical Science (vol. 132, issue 6, 685-699), Ma et al. describe that the anti-inflammatory drug leflunomide markedly antagonized CH, dysfunction, and fibrosis induced by aortic banding or angiotensin-II in mice or by agonists in cultured cells. Unexpectedly, this occurred not via anti-inflammatory mechanisms but rather via inhibtion of Akt (protein kinase B, PKB) signaling. We further discuss the mechanisms underlying Akt activation and its effects on CH and review possible mechanisms of leflunomide effects. Despite some caveats, the availability of such a newly repurposed compound to treat CH can be a relevant advance. © 2018 The Author(s). Published by Portland Press Limited on behalf of the Biochemical Society.

Putting the value into biosimilar decision making: the judgment value criteria.

PubMed

Mendes de Abreu, Mirhelen; Strand, Vibeke; Levy, Roger Abramino; Araujo, Denizar Vianna

2014-06-01

Uncertainties remain the key issue surrounding biosimilars, although decisions regarding their use must be made. The challenges for policymakers, doctors, patients and others seeking to navigate in the uncharted waters of biosimilars must be clarified. At the most basic level, scientific understanding of the issue remains limited and when making decisions, policymakers must consider all those affected by health policy decisions, particularly the ultimate recipients of these medicines: the patients. The biosimilar-value chain relies on measurement of comparabilities. The goal is to demonstrate how, from a molecular perspective, closely similar they are or are not and how potential small differences may be relevant to clinical outcomes. To critically understand these points, this conceptual paper will present a knowledge-value chain and discuss each dimension assigning value in the decision making process re-utilization of biosimilars. Copyright © 2014 Elsevier B.V. All rights reserved.

Inducible indoleamine 2,3-dioxygenase 1 and programmed death ligand 1 expression as the potency marker for mesenchymal stromal cells.

PubMed

Guan, Qingdong; Li, Yun; Shpiruk, Tanner; Bhagwat, Swaroop; Wall, Donna A

2018-05-01

Establishment of a potency assay in the manufacturing of clinical-grade mesenchymal stromal cells (MSCs) has been a challenge due to issues of relevance to function, timeline and variability of responder cells. In this study, we attempted to develop a potency assay for MSCs. Clinical-grade bone marrow-derived MSCs were manufactured. The phenotype and immunosuppressive functions of the MSCs were evaluated based on the International Society for Cellular Therapy guidelines. Resting MSCs licensed by interferon (IFN)-γ exposure overnight were evaluated for changes in immune suppression and immune-relevant proteins. The relationship of immune-relevant protein expression with immunosuppression of MSCs was analyzed. MSC supressed third-party T-lymphocyte proliferation with high inter-donor and inter-test variability. The suppression of T-lymphocyte proliferation by IFN-γ-licensed MSCs correlated with that by resting MSCs. Many cellular proteins were up-regulated after IFN-γ exposure, including indoleamine 2,3-dioxygenase 1 (IDO-1), programmed death ligand 1 (PD-L1), vascular cell adhesion molecule 1 (VCAM-1), intercellular adhesion molecule 1 (ICAM-1) and bone marrow stromal antigen 2 (BST-2). The expression levels of IDO-1 and PD-L1 on licensed MSCs, not VCAM-1, ICAM-1 or BST-2 on licensed MSCs, correlated with MSC suppression of third-party T-cell proliferation. A flow cytometry-based assay of MSCs post-IFN-γ exposure measuring expression of intracellular protein IDO-1 and cell surface protein PD-L1 captures two mechanisms of suppression and offers the potential of a relevant, rapid assay for MSC-mediated immune suppression that would fit with the manufacturing process. Copyright © 2018 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

From competencies to human interests: ways of knowing and understanding in medical education.

PubMed

Kumagai, Arno K

2014-07-01

When considering the teaching and learning of topics of social relevance in medicine, such as professionalism, medical ethics, the doctor-patient relationship, and issues of diversity and social justice, one is tempted to ask, are the ways of knowing in these fields different from that in the biomedical and clinical sciences? Furthermore, given that the competency approach is dominant in medical education, one might also ask, is the competency model truly appropriate for all of the types of knowledge necessary to become a good physician? These questions are not merely academic, for they are at the core of how these subjects are taught, learned, and assessed.The goal of this article is threefold: first, to explore the nature of knowing and the educational goals in different areas of medicine and, in particular, those areas that have social relevance; second, to critically review the concept of competencies when applied to education in these areas; and third, to explore alternative strategies for teaching, learning, and assessment. This discussion reflects a view that the goal of education in areas of social relevance in medicine should be the enhancement of an understanding of-a deep and abiding connection with-the social responsibilities of the physician. Moving beyond competencies, this approach aspires toward the development of practical wisdom (phronesis) which, when embodied in the physician, links the knowledge and skills of the biomedical and clinical sciences with a moral orientation and call to action that addresses human interests in the practice of medicine.

Thyrotropin receptor mutations and thyroid hyperfunctioning adenomas ten years after their first discovery: unresolved questions.

PubMed

Arturi, F; Scarpelli, D; Coco, A; Sacco, R; Bruno, R; Filetti, S; Russo, D

2003-04-01

Ten years after the first description of activating mutations in the thyroid stimulating hormone receptor (TSHR) gene in sporadic autonomous hyperfunctioning thyroid adenomas, there is general agreement in assigning a major pathogenic role of this genetic abnormality, acting via the constitutive activation of the cAMP pathway, in both the growth and functional characteristic of these tumours. From the beginning, however, the pathophysiological and clinical relevance of somatic TSHR mutations has been debated and some arguments still exist against a fully causative role of these mutations and the practical value of detecting these mutations for the diagnosis, treatment and prognosis of thyroid hot nodules. Some major issues will be examined herein, including (a) the frequency of TSHR alterations in various reports showing that the genetic abnormality underlying the pathogenesis of a substantial subset of thyroid tumours has yet to be identified; (b) the limitations of the present experimental models, which suggest greater caution in the interpretation of in vitro results; (c) the still unresolved question of absence of genotype-phenotype correlation. Clarification of these issues may hopefully provide new and useful tools for improving the clinical management of this disease.

Insight in schizophrenia: a review.

PubMed

Dam, Jesper

2006-01-01

The issue of insight in schizophrenia must be assumed to be one of the most important aspects of the clinical examination. Comprehensive studies have shown that between 50% and 80% of all patients suffering from schizophrenia do not believe that they have a disorder. In recent years, poor insight in schizophrenia has been the subject of increasing interest, as manifested in a number of studies discussed in the present review. Some of these studies focus on insight correlated to various parameters such as psychopathology, neuropsychology, clinical relevance and compliance. Other studies refer to more theoretical implications, among these the issue of defining the concept of insight: whether insight can be seen as a "primary" phenomenon in schizophrenia, and whether insight may be graduated, dimensioned or increased. Several authors have developed rating scales in an attempt to obtain a measure for the degree or dimension of insight. Here, the range of parameters employed gives an excellent impression of the complexity of the concept of insight. In the concluding discussion, a phenomenological aspect is brought in, in an attempt to place the concept of insight in relation to disturbances of the self in schizophrenia and to primary symptoms in schizophrenia, amongst these autism.

Schizophrenia in women and children: a selective review of literature from developing countries.

PubMed

Chandra, Prabha S; Kommu, John Vijay Sagar; Rudhran, Vidyendran

2012-10-01

Women and children with psychotic disorders in developing countries may be vulnerable and have considerable social disadvantages. Gender disadvantage has implications for all health outcomes including mental illnesses. In the more relevant gender-related context we discuss several important issues which affect women with schizophrenia, namely stigma, caregiver burden, functional outcome, marriage, victimization and help-seeking. The findings indicate that there are variations in clinical and functional outcomes and age of onset of illness between different regions. Drug side effects, such as metabolic syndrome appear to be quite common, adding to disease burden in women from developing countries. Victimization and coercion may contribute to poor quality of life and health concerns such as STIs and HIV. Stigma among women with schizophrenia appears to play a major role in help-seeking, caregiver burden and issues such as marriage and parenting. Gender-sensitive care and practices are few and not well documented. Research in the area of psychoses in children and adolescents from LAMI countries is sparse and is mainly restricted to a few clinic-based studies. More research is needed on organic and medical factors contributing to childhood psychoses, pathways to care, help-seeking, and impact of early detection and community care.

Using a communication audit to improve communication on clinical placement in pre-registration nursing.

PubMed

Hogard, Elaine; Ellis, Roger; Ellis, Jackie; Barker, Chris

2005-02-01

This article describes a novel communication audit conducted with those concerned with the practice placements of pre-registration Nursing students. The study, uniquely, addressed all who were involved in communication concerning placement in what is described as an organisational analysis. The aim of the audit was to identify levels of satisfaction and dissatisfaction with present communication processes and to identify points for improvement. The audit used the Hogard-Barker Communication Audit of Practice a customized version of a well established tool, devised to cover issues relevant to practice placements. A key feature of the tool is the opportunity for participants to identify the amount of communication they are receiving on particular topics and issues against the amount they would like to receive. Participants in the audit included students, assessor mentors, ward managers, clinical facilitators and link tutors. Overall there was considerable dissatisfaction with what was perceived to be the insufficient amount of communication received on a number of topics including allocations, the curriculum, students' learning outcomes and commitments in terms of college work. In addition to identifying points for improvement the audit provides a baseline against which progress can be assessed through a future audit.

Proposal for an Update of the Definition and Scope of Behavioral Medicine.

PubMed

Dekker, Joost; Stauder, Adrienne; Penedo, Frank J

2017-02-01

We aim to provide an update of the definition and scope of behavioral medicine in the Charter of ISBM, as the present version was developed more than 25 years ago. We identify issues which need clarification or updating. This leads us to propose an update of the definition and scope of behavioral medicine. Issues in need of clarification or updating include the scope of behavioral medicine (biobehavioral mechanisms, clinical diagnosis and intervention, and prevention and health promotion); research as an essential characteristic of all three areas of behavioral medicine; the application of behavioral medicine; the terminology of behavioral medicine as a multidisciplinary field; and the relationship and distinction between behavioral medicine, mental health, health psychology, and psychosomatic medicine. We propose the following updated definition and scope of behavioral medicine: "Behavioral medicine can be defined as the multidisciplinary field concerned with the development and integration of biomedical and behavioral knowledge relevant to health and disease, and the application of this knowledge to prevention, health promotion, diagnosis, treatment, rehabilitation, and care. The scope of behavioral medicine extends from biobehavioral mechanisms (i.e., the interaction of biomedical processes with psychological, social, societal, cultural, and environmental processes), to clinical diagnosis and intervention, and to public health."

What does meaningful look like? A qualitative study of patient engagement at the Pan-Canadian Oncology Drug Review: perspectives of reviewers and payers.

PubMed

Rozmovits, Linda; Mai, Helen; Chambers, Alexandra; Chan, Kelvin

2018-04-01

Objectives While there is wide support for patient engagement in health technology assessment, determining what constitutes meaningful (as opposed to tokenistic) engagement is complex. This paper explores reviewer and payer perceptions of what constitutes meaningful patient engagement in the Pan-Canadian Oncology Drug Review process. Methods Qualitative interview study comprising 24 semi-structured telephone interviews. A qualitative descriptive approach, employing the technique of constant comparison, was used to produce a thematic analysis. Results Submissions from patient advocacy groups were seen as meaningful when they provided information unavailable from other sources. This included information not collected in clinical trials, information relevant to clinical trade-offs and information about aspects of lived experience such as geographic differences and patient and carer priorities. In contrast, patient submissions that relied on emotional appeals or lacked transparency about their own methods were seen as detracting from the meaningfulness of patient engagement by conflating health technology assessment with other functions of patient advocacy groups such as fundraising or public awareness campaigns, and by failing to provide credible information relevant to deliberations. Conclusions This study suggests that misalignment of stakeholder expectations remains an issue even for a well-regarded health technology assessment process that has promoted patient engagement since its inception. Support for the technical capacity of patient groups to participate in health technology assessment is necessary but not sufficient to address this issue fully. There is a fundamental tension between the evidence-based nature of health technology assessment and the experientially oriented culture of patient advocacy. Divergent notions of what constitutes evidence and how it should be used must also be addressed.

Biomarkers of Nutrition for Development—Iodine Review1234

PubMed Central

Rohner, Fabian; Zimmermann, Michael; Jooste, Pieter; Pandav, Chandrakant; Caldwell, Kathleen; Raghavan, Ramkripa; Raiten, Daniel J.

2014-01-01

The objective of the Biomarkers of Nutrition for Development (BOND) project is to provide state-of-the-art information and service with regard to selection, use, and interpretation of biomarkers of nutrient exposure, status, function, and effect. Specifically, the BOND project seeks to develop consensus on accurate assessment methodologies that are applicable to researchers (laboratory/clinical/surveillance), clinicians, programmers, and policy makers (data consumers). The BOND project is also intended to develop targeted research agendas to support the discovery and development of biomarkers through improved understanding of nutrient biology within relevant biologic systems. In phase I of the BOND project, 6 nutrients (iodine, vitamin A, iron, zinc, folate, and vitamin B-12) were selected for their high public health importance because they typify the challenges faced by users in the selection, use, and interpretation of biomarkers. For each nutrient, an expert panel was constituted and charged with the development of a comprehensive review covering the respective nutrient’s biology, existing biomarkers, and specific issues of use with particular reference to the needs of the individual user groups. In addition to the publication of these reviews, materials from each will be extracted to support the BOND interactive Web site (http://www.nichd.nih.gov/global_nutrition/programs/bond/pages/index.aspx). This review represents the first in the series of reviews and covers all relevant aspects of iodine biology and biomarkers. The article is organized to provide the reader with a full appreciation of iodine’s background history as a public health issue, its biology, and an overview of available biomarkers and specific considerations for the use and interpretation of iodine biomarkers across a range of clinical and population-based uses. The review also includes a detailed research agenda to address priority gaps in our understanding of iodine biology and assessment. PMID:24966410

Bibliometric analysis on Australian rural health publications from 2006 to 2012.

PubMed

Mendis, Kumara; Edwards, Tegan; Stevens, Wendy; McCrossin, Tim

2014-08-01

To review Australian rural health (ARH) publications in PubMed from 2006 to 2012 and address ARH issues raised by the 2013 Health and Medical Research report. Retrospective observational study. Internet-based bibliometric analysis using PubMed. MEDLINE-indexed ARH publications from 2006 to 2012 were retrieved using PubMed queries. ARH publications were defined as Australian publications that explore issues relevant to the health of the regional, rural or remote Australian population. Two authors independently reviewed a random sample of 5% of publications for validity. Analysis determined country of origin (Australia); publications relevant to the National Health Priority Areas, the 2013 National Rural Health Alliance priority areas and Rural Clinical Schools/University Departments of Rural Health; and journal frequencies and publication types. ARH publications increased from 286 in 2006 to 393 in 2012 and made up 1.4% of all Australian PubMed publications. Combined, the health priority areas were addressed in 52% of ARH publications. Rural Clinical Schools/University Departments of Rural Health articles made up 7% of ARH publications. An increase in cohort studies, systematic reviews and reviews indicated improved quality of articles. ARH articles were most commonly published in the Australian Journal of Rural Health (15.9%), Rural and Remote Health (13.4%) and the Medical Journal of Australia (6.3%). Striking a balance between broadening the queries (increasing sensitivity) and limiting the false positives by restricting the breadth of the queries (increasing specificity) was the main limitation. This reproducible analysis, repeated at given timelines, can track the progress of ARH publications and provide directions regarding future rural health research. © 2014 National Rural Health Alliance Inc.

Tendon Tissue Engineering: Progress, Challenges, and Translation to the Clinic

PubMed Central

Shearn, Jason T.; Kinneberg, Kirsten R.C.; Dyment, Nathaniel A.; Galloway, Marc T.; Kenter, Keith; Wylie, Christopher; Butler, David L.

2013-01-01

The tissue engineering field has made great strides in understanding how different aspects of tissue engineered constructs (TECs) and the culture process affect final tendon repair. However, there remain significant challenges in developing strategies that will lead to a clinically effective and commercially successful product. In an effort to increase repair quality, a better understanding of normal development, and how it differs from adult tendon healing, may provide strategies to improve tissue engineering. As tendon tissue engineering continues to improve, the field needs to employ more clinically relevant models of tendon injury such as degenerative tendons. We need to translate successes to larger animal models to begin exploring the clinical implications of our treatments. By advancing the models used to validate our TECs, we can help convince our toughest customer, the surgeon, that our products will be clinically efficacious. As we address these challenges in musculoskeletal tissue engineering, the field still needs to address the commercialization of products developed in the laboratory. TEC commercialization faces numerous challenges because each injury and patient is unique. This review aims to provide tissue engineers with a summary of important issues related to engineering tendon repairs and potential strategies for producing clinically successful products. PMID:21625053

The Effects of Aging on Clinical Vestibular Evaluations

PubMed Central

Maheu, Maxime; Houde, Marie-Soleil; Landry, Simon P.; Champoux, François

2015-01-01

Balance disorders are common issues for aging populations due to the effects of normal aging on peripheral vestibular structures. These changes affect the results of vestibular function evaluations and make the interpretation of these results more difficult. The objective of this article is to review the current state of knowledge of clinically relevant vestibular measures. We will first focus on otolith function assessment methods cervical-VEMP (cVEMP) and ocular-VEMP (oVEMP), then the caloric and video-head impulse test (vHIT) methods for semicircular canals assessment. cVEMP and oVEMP are useful methods, though research on the effects of age for some parameters are still inconclusive. vHIT results are largely independent of age as compared to caloric stimulation and should therefore be preferred for the evaluation of the semicircular canals function. PMID:26441824

Year in review 2005: Critical Care – nephrology

PubMed Central

Ricci, Zaccaria; Ronco, Claudio

2006-01-01

We summarize original research in the field of critical care nephrology accepted or published in 2005 in Critical Care and, when considered relevant or directly linked to this research, in other journals. The articles have been grouped into four categories to facilitate a rapid overview. First, physiopathology, epidemiology and prognosis of acute renal failure (ARF): an extensive review and some observational studies have been performed with the aim of describing aspects of ARF physiopathology, precise epidemiology and long-term outcomes. Second, several authors have performed clinical trials utilizing a potential nephro-protective drug, fenoldopam, with different results. Third, the issue of continuous renal replacement therapies dose has been addressed in a small prospective study and a large observational trial. And fourth, alternative indications to extracorporeal treatment of ARF and systemic inflammatory response syndrome have been explored by three original clinical studies. PMID:16919174

Defining delirium for the International Classification of Diseases, 11th Revision.

PubMed

Meagher, David J; Maclullich, Alasdair M J; Laurila, Jouko V

2008-09-01

The development of ICD-11 provides an opportunity to update the description of delirium according to emerging data that have added to our understanding of this complex neuropsychiatric syndrome. Synthetic article based on published work considered by the authors to be relevant to the definition of delirium. The current DSM-IV definition of delirium is preferred to the ICD-10 because of its greater inclusivity. Evidence does not support major changes in the principal components of present definitions but a number of key issues for the updated definition were identified. These include better account of non-cognitive features, more guidance for rating contextual diagnostic items, clearer definition regarding the interface with dementia, and accounting for illness severity, clinical subtypes and course. Development of the ICD definition of delirium can allow for more targeted research and clinical effort.

A context-adaptable approach to clinical guidelines.

PubMed

Terenziani, Paolo; Montani, Stefania; Bottrighi, Alessio; Torchio, Mauro; Molino, Gianpaolo; Correndo, Gianluca

2004-01-01

One of the most relevant obstacles to the use and dissemination of clinical guidelines is the gap between the generality of guidelines (as defined, e.g., by physicians' committees) and the peculiarities of the specific context of application. In particular, general guidelines do not take into account the fact that the tools needed for laboratory and instrumental investigations might be unavailable at a given hospital. Moreover, computer-based guideline managers must also be integrated with the Hospital Information System (HIS), and usually different DBMS are adopted by different hospitals. The GLARE (Guideline Acquisition, Representation and Execution) system addresses these issues by providing a facility for automatic resource-based adaptation of guidelines to the specific context of application, and by providing a modular architecture in which only limited and well-localised changes are needed to integrate the system with the HIS at hand.

Application of Immunohistochemistry and Molecular Diagnostics to Clinically Relevant Problems in Endometrial Cancer Bojana Djordjevic, Shannon Westin, Russell R. Broaddus

PubMed Central

Djordjevic, Bojana; Westin, Shannon; Broaddus, Russell R.

2012-01-01

Synopsis A number of different clinical scenarios are presented in which lab-based analyses beyond the usual diagnosis based on light microscopic examination of H&E stained slides – immunohistochemistry and PCR-based assays such as sequencing, mutation testing, microsatellite instability analysis, and determination of MLH1 methylation - are most helpful for guiding diagnosis and treatment of endometrial cancer. The central goal of this information is to provide a practical guide of key current and emerging issues in diagnostic endometrial cancer pathology that require the use of ancillary laboratory techniques, such as immunohistochemistry and molecular testing. The authors present the common diagnostic problems in endometrial carcinoma pathology, types of endometrial carcinoma, description of tissue testing and markers, pathological features, and targeted therapy. PMID:23687522

21 CFR 1271.75 - How do I screen a donor?

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Risk factors for, and clinical evidence of, relevant communicable disease agents and diseases... risk factors for and clinical evidence of relevant cell-associated communicable disease agents and... having either of the following: (1) A risk factor for or clinical evidence of any of the relevant...

Clinical neuropsychology practice and training in Canada.

PubMed

Janzen, Laura A; Guger, Sharon

2016-11-01

This invited paper provides information about professional neuropsychology issues in Canada and is part of a special issue addressing international perspectives on education, training, and practice in clinical neuropsychology. Information was gathered from literature searches and personal communication with other neuropsychologists in Canada. Canada has a rich neuropsychological history. Neuropsychologists typically have doctoral-level education including relevant coursework and supervised practical experience. Licensure requirements vary across the 10 provinces and there are regional differences in salary. While training at the graduate and internship level mirrors that of our American colleagues, completion of a two-year postdoctoral fellowship in neuropsychology is not required to obtain employment in many settings and there are few postdoctoral training programs in this country. The majority of neuropsychologists are employed in institutional settings (e.g. hospitals, universities, rehabilitation facilities), with a growing number entering private practice or other settings. There are challenges in providing neuropsychological services to the diverse Canadian population and a need for assessment measures and normative data in multiple languages. Canadian neuropsychologists face important challenges in defining ourselves as distinct from other professions and other psychologists, in maintaining funding for high-quality training and research, in establishing neuropsychology-specific training and practice standards at the provincial or national level, and ensuring the clinical care that we provide is efficient and effective in meeting the needs of our patient populations and consumers, both within and outside of the publically funded health care system.

Concise review: Nanoparticles and cellular carriers-allies in cancer imaging and cellular gene therapy?

PubMed Central

Tang, Catherine; Russell, Pamela J; Martiniello-Wilks, Rosetta; J Rasko, John E; Khatri, Aparajita

2010-01-01

Ineffective treatment and poor patient management continue to plague the arena of clinical oncology. The crucial issues include inadequate treatment efficacy due to ineffective targeting of cancer deposits, systemic toxicities, suboptimal cancer detection and disease monitoring. This has led to the quest for clinically relevant, innovative multifaceted solutions such as development of targeted and traceable therapies. Mesenchymal stem cells (MSCs) have the intrinsic ability to “home” to growing tumors and are hypoimmunogenic. Therefore, these can be used as (a) “Trojan Horses” to deliver gene therapy directly into the tumors and (b) carriers of nanoparticles to allow cell tracking and simultaneous cancer detection. The camouflage of MSC carriers can potentially tackle the issues of safety, vector, and/or transgene immunogenicity as well as nanoparticle clearance and toxicity. The versatility of the nanotechnology platform could allow cellular tracking using single or multimodal imaging modalities. Toward that end, noninvasive magnetic resonance imaging (MRI) is fast becoming a clinical favorite, though there is scope for improvement in its accuracy and sensitivity. In that, use of superparamagnetic iron-oxide nanoparticles (SPION) as MRI contrast enhancers may be the best option for tracking therapeutic MSC. The prospects and consequences of synergistic approaches using MSC carriers, gene therapy, and SPION in developing cancer diagnostics and therapeutics are discussed. STEM CELLS 2010; 28:1686–1702. PMID:20629172

Update in cardiology: vascular risk and cardiac rehabilitation.

PubMed

Galve, Enrique; Alegría, Eduardo; Cordero, Alberto; Fácila, Lorenzo; Fernández de Bobadilla, Jaime; Lluís-Ganella, Carla; Mazón, Pilar; de Pablo Zarzosa, Carmen; González-Juanatey, José Ramón

2014-03-01

Cardiovascular disease develops in a slow and subclinical manner over decades, only to manifest suddenly and unexpectedly. The role of prevention is crucial, both before and after clinical appearance, and there is ample evidence of the effectiveness and usefulness of the early detection of at-risk individuals and lifestyle modifications or pharmacological approaches. However, these approaches require time, perseverance, and continuous development. The present article reviews the developments in 2013 in epidemiological aspects related to prevention, includes relevant contributions in areas such as diet, weight control methods (obesity is now considered a disease), and physical activity recommendations (with warnings about the risk of strenuous exercise), deals with habit-related psychosocial factors such as smoking, provides an update on emerging issues such as genetics, addresses the links between cardiovascular disease and other pathologies such as kidney disease, summarizes the contributions of new, updated guidelines (3 of which have recently been released on topics of considerable clinical importance: hypertension, diabetes mellitus, and chronic kidney disease), analyzes the pharmacological advances (largely mediocre except for promising lipid-related results), and finishes by outlining developments in the oft-neglected field of cardiac rehabilitation. This article provides a briefing on controversial issues, presents interesting and somewhat surprising developments, updates established knowledge with undoubted application in clinical practice, and sheds light on potential future contributions. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

Perspective: Entering uncharted waters: navigating the transition from trainee to career for the nonphysician clinician-scientist.

PubMed

MacDonald, Shannon E; Sharpe, Heather M; Shikako-Thomas, Keiko; Larsen, Bodil; MacKay, Lyndsay

2013-01-01

The transition from trainee to career clinician-scientist can be a stressful and challenging time, particularly for those entering the less established role of nonphysician clinician-scientist. These individuals are typically PhD-prepared clinicians in the allied health professions, who have either a formal or informal joint appointment between a clinical institution and an academic or research institution. The often poorly defined boundaries and expectations of these developing roles can pose additional challenges for the trainee-to-career transition.It is important for these trainees to consider what they want and need in a position in order to be successful, productive, and fulfilled in both their professional and personal lives. It is also critical for potential employers, whether academic or clinical (or a combination of both), to be fully aware of the supports and tools necessary to recruit and retain new nonphysician clinician-scientists. Issues of relevance to the trainee and the employer include finding and negotiating a position; the importance of mentorship; the value of effective time management, particularly managing clinical and academic time commitments; and achieving work-life balance. Attention to these issues, by both the trainee and those in a position to hire them, will facilitate a smooth transition to the nonphysician clinician-scientist role and ultimately contribute to individual and organizational success.

Quality in transitional care of the elderly: Key challenges and relevant improvement measures

PubMed Central

Storm, Marianne; Siemsen, Inger Margrete D.; Laugaland, Kristin; Dyrstad, Dagrunn Nåden; Aase, Karina

2014-01-01

Introduction Elderly people aged over 75 years with multifaceted care needs are often in need of hospital treatment. Transfer across care levels for this patient group increases the risk of adverse events. The aim of this paper is to establish knowledge of quality in transitional care of the elderly in two Norwegian hospital regions by identifying issues affecting the quality of transitional care and based on these issues suggest improvement measures. Methodology Included in the study were elderly patients (75+) receiving health care in the municipality admitted to hospital emergency department or discharged to community health care with hip fracture or with a general medical diagnosis. Participant observations of admission and discharge transitions (n = 41) were carried out by two researchers. Results Six main challenges with belonging descriptions have been identified: (1) next of kin (bridging providers, advocacy, support, information brokering), (2) patient characteristics (level of satisfaction, level of insecurity, complex clinical conditions), (3) health care personnel's competence (professional, system, awareness of others’ roles), (4) information exchange (oral, written, electronic), (5) context (stability, variability, change incentives, number of patient handovers) and (6) patient assessment (complex clinical picture, patient description, clinical assessment). Conclusion Related to the six main challenges, several measures have been suggested to improve quality in transitional care, e.g. information to and involvement of patients and next of kin, staff training, standardisation of routines and inter-organisational staff meetings. PMID:24868196

Building an Ontology for Identity Resolution in Healthcare and Public Health.

PubMed

Duncan, Jeffrey; Eilbeck, Karen; Narus, Scott P; Clyde, Stephen; Thornton, Sidney; Staes, Catherine

2015-01-01

Integration of disparate information from electronic health records, clinical data warehouses, birth certificate registries and other public health information systems offers great potential for clinical care, public health practice, and research. Such integration, however, depends on correctly matching patient-specific records using demographic identifiers. Without standards for these identifiers, record linkage is complicated by issues of structural and semantic heterogeneity. Our objectives were to develop and validate an ontology to: 1) identify components of identity and events subsequent to birth that result in creation, change, or sharing of identity information; 2) develop an ontology to facilitate data integration from multiple healthcare and public health sources; and 3) validate the ontology's ability to model identity-changing events over time. We interviewed domain experts in area hospitals and public health programs and developed process models describing the creation and transmission of identity information among various organizations for activities subsequent to a birth event. We searched for existing relevant ontologies. We validated the content of our ontology with simulated identity information conforming to scenarios identified in our process models. We chose the Simple Event Model (SEM) to describe events in early childhood and integrated the Clinical Element Model (CEM) for demographic information. We demonstrated the ability of the combined SEM-CEM ontology to model identity events over time. The use of an ontology can overcome issues of semantic and syntactic heterogeneity to facilitate record linkage.

Moving toward mainstream: perspectives on enhancing therapy with men.

PubMed

Wade, Jay C; Good, Glenn E

2010-09-01

Psychotherapists began sharing their clinical experiences with men's gender-related psychological issues and the challenges of addressing them in therapy during the late 1970s and early 1980s (e.g., O'Neil, 1981; Scher, 1979; Skovholt, 1978). However, it has taken several decades for these messages and the accompanying research to yield advances that are being adopted into more mainstream psychotherapeutic practices. Over the recent three decades, the theory, research, and clinical wisdom about psychotherapy with men can be viewed as falling into several main clusters. Specifically, there is literature and research providing: - General information on masculine socialization and the psychology of men. - Information about specific issues that men and male clients bring to therapy. - Information about the expectations and experiences of specific groups of men (e.g., men of differing racial/ethnic backgrounds, geographical regions, age cohorts, spiritual/religious beliefs, differing physical ability statuses). - Suggestions for addressing men's reluctance to seek psychotherapy and the challenges associated with forming therapeutic working alliances with men when they do come to therapy. - Suggestions regarding adjustments to psychotherapeutic processes for conducting effective psychotherapy with men. - Development and assessment of instruments to assess endorsement of various male norms and of aspects of men's gender role conflict and stress. Reviewing the earliest writings, some of these pioneering therapists' initial clinical observations remain highly relevant today. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

Should we genetically test everyone for haemochromatosis?

PubMed

Allen, K; Williamson, R

1999-04-01

The increasing availability of DNA-based diagnostic tests has raised issues about whether these should be applied to the population at large in order to identify, treat or prevent a range of diseases. DNA tests raise concerns in the community for several reasons. There is the possibility of stigmatisation and discrimination between those who test positive and those who don't. High-risk individuals may be identified for whom no proven effective intervention is possible, or conversely may test "positive" for a disease that does not eventuate. Controversy concerning prenatal diagnosis and termination of affected pregnancies may arise. Haemochromatosis, however, is a disease that is not only treatable but also preventable if those at high risk are identified presymptomatically. This paper will identify and discuss key issues regarding DNA-based population screening for haemochromatosis, and argue that population-based genetic screening for haemochromatosis should be supported when a number of contentious issues are addressed. In the context of a health system with limited resources haemochromatosis is the paradigm of a disorder where there is an ethical and clinical imperative to encourage presymptomatic DNA testing for all in ethnically relevant communities.

Prenatal Testing for Adult-Onset Conditions: the Position of the National Society of Genetic Counselors.

PubMed

Hercher, Laura; Uhlmann, Wendy R; Hoffman, Erin P; Gustafson, Shanna; Chen, Kelly M

2016-12-01

Advances in genetic testing and the availability of such testing in pregnancy allows prospective parents to test their future child for adult-onset conditions. This ability raises several complex ethical issues. Prospective parents have reproductive rights to obtain information about their fetus. This information may or may not alter pregnancy management. These rights can be in conflict with the rights of the future individual, who will be denied the right to elect or decline testing. This paper highlights the complexity of these issues, details discussions that went into the National Society of Genetic Counselors (NSGC) Public Policy Task Force's development of the Prenatal testing for Adult-Onset Conditions position statement adopted in November 2014, and cites relevant literature on this topic through December 2015. Issues addressed include parental rights and autonomy, rights of the future child, the right not to know, possible adverse effects on childhood and the need for genetic counseling. This paper will serve as a reference to genetic counselors and healthcare professionals when faced with this situation in clinical practice.

Clinical pharmacology in Russia-historical development and current state.

PubMed

Zagorodnikova Goryachkina, Ksenia; Burbello, Aleksandra; Sychev, Dmitry; Frolov, Maxim; Kukes, Vladimir; Petrov, Vladimir

2015-02-01

Clinical pharmacology in Russia has long history and is currently active, but rather unrecognized internationally. It is governmentally approved as a teaching/scientific specialty since 1983 and as a medical specialty since 1997. Courses of clinical pharmacology are included in the undergraduate curricula in the 5th and/or 6th year of education at all medical schools in the Russian Federation. Postgraduate education includes initial specialization in internal medicine with further residency in clinical pharmacology. Governmental legislation recommends that every healthcare institution has either a department or a single position of clinical pharmacologist. Major routine duties include information about and monitoring of medication use, consultations in difficult clinical situations, pharmacogenetic counseling, therapeutic drug monitoring, pharmacovigilance, and participation in drug and therapeutics (formulary) committees. There are official experts in clinical pharmacology in Russia responsible for coordinating relevant legislative issues. The chief expert clinical pharmacologist represents the discipline directly at the Ministry of Health. Research in clinical pharmacology in Russia is extensive and variable, but only some of it is published internationally. Russia is a participant of international societies of clinical pharmacology and therapeutics and collaboration is actively ongoing. There are still certain problems related to the development of the discipline in Russia-some healthcare institutions do not see the need for clinical pharmacology. However, the number of clinical pharmacologists in Russia is increasing as well as their role in physicians' education, national healthcare, and research.

The National Institutes of Health Clinical Center

MedlinePlus

... Issue Past Issues The National Institutes of Health Clinical Center Past Issues / Spring 2007 Table of Contents ... Communications, NIH Clinical Center Welcome to the nation's clinical research hospital. The NIH Clinical Center: For more ...

Quality considerations in midwifery pre-service education: exemplars from Africa.

PubMed

Fullerton, Judith T; Johnson, Peter G; Thompson, Joyce B; Vivio, Donna

2011-06-01

This paper uses comparisons and contrasts identified during an assessment of pre-service education for midwives in three countries in sub-Saharan Africa. The purpose of the paper is to stimulate discussion about issues that must be carefully considered in the context of midwifery educational programming and the expansion of the midwifery workforce. A mixed qualitative and quantitative participatory assessment was conducted in Ethiopia, Ghana and Malawi, in the context of a final review of outcomes of a USAID-funded global project (ACCESS). Quantitative surveys were distributed. Individual and focus group interviews were conducted. Participants included key informants at donor, government and policy-making levels, representatives of collaborating and supporting agencies, midwives and students in education programmes, and midwives in clinical practice. Information is presented concerning the challenges encountered by those responsible for midwifery pre-service education related to issues in programming including: pathways to midwifery, student recruitment and admission, midwifery curricula, preparation of faculty to engage in academic teaching and clinical mentorship, modes of curriculum dissemination and teaching/learning strategies, programme accreditation, qualifications for entry-into practice and the assessment of continued competence. Quality issues must be carefully considered when designing and implementing midwifery pre-service education programmes, and planning for the integration of new graduates into the health workforce. These issues, such as the availability of qualified tutors and clinical teachers, and measures for the implementation of competency-based teaching and learner-assessment strategies, are particularly relevant in countries that experience health manpower shortages. This review highlights important strategic choices that can be made to enhance the quality of pre-service midwifery education. The deployment, appropriate utilisation and increased number of highly qualified midwifery graduates can improve the quality of maternal and newborn health-care service, and reduce maternal and newborn mortality. Copyright © 2010 Elsevier Ltd. All rights reserved.

Towards pervasive computing in health care – A literature review

PubMed Central

Orwat, Carsten; Graefe, Andreas; Faulwasser, Timm

2008-01-01

Background The evolving concepts of pervasive computing, ubiquitous computing and ambient intelligence are increasingly influencing health care and medicine. Summarizing published research, this literature review provides an overview of recent developments and implementations of pervasive computing systems in health care. It also highlights some of the experiences reported in deployment processes. Methods There is no clear definition of pervasive computing in the current literature. Thus specific inclusion criteria for selecting articles about relevant systems were developed. Searches were conducted in four scientific databases alongside manual journal searches for the period of 2002 to 2006. Articles included present prototypes, case studies and pilot studies, clinical trials and systems that are already in routine use. Results The searches identified 69 articles describing 67 different systems. In a quantitative analysis, these systems were categorized into project status, health care settings, user groups, improvement aims, and systems features (i.e., component types, data gathering, data transmission, systems functions). The focus is on the types of systems implemented, their frequency of occurrence and their characteristics. Qualitative analyses were performed of deployment issues, such as organizational and personnel issues, privacy and security issues, and financial issues. This paper provides a comprehensive access to the literature of the emerging field by addressing specific topics of application settings, systems features, and deployment experiences. Conclusion Both an overview and an analysis of the literature on a broad and heterogeneous range of systems are provided. Most systems are described in their prototype stages. Deployment issues, such as implications on organization or personnel, privacy concerns, or financial issues are mentioned rarely, though their solution is regarded as decisive in transferring promising systems to a stage of regular operation. There is a need for further research on the deployment of pervasive computing systems, including clinical studies, economic and social analyses, user studies, etc. PMID:18565221

"Biosphere Reserve"--The Actual Research Subject of the Sustainable Development Process"

ERIC Educational Resources Information Center

Khasaev, Gabibulla R.; Sadovenko, Marina Yu.; Isaev, Roman O.

2016-01-01

The relevance of the analyzed issue is caused by the growing slippage of research funds of sustainable development in its practice. The purpose of the article is the theoretical basis of the biosphere reserve as a scientific research subject that is relevant to rules of the scientific activity. The leading approach to the study of this issue is…

Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core.

PubMed

Cook, Andrea J; Delong, Elizabeth; Murray, David M; Vollmer, William M; Heagerty, Patrick J

2016-10-01

Pragmatic clinical trials embedded within health care systems provide an important opportunity to evaluate new interventions and treatments. Networks have recently been developed to support practical and efficient studies. Pragmatic trials will lead to improvements in how we deliver health care and promise to more rapidly translate research findings into practice. The National Institutes of Health (NIH) Health Care Systems Collaboratory was formed to conduct pragmatic clinical trials and to cultivate collaboration across research areas and disciplines to develop best practices for future studies. Through a two-stage grant process including a pilot phase (UH2) and a main trial phase (UH3), investigators across the Collaboratory had the opportunity to work together to improve all aspects of these trials before they were launched and to address new issues that arose during implementation. Seven Cores were created to address the various considerations, including Electronic Health Records; Phenotypes, Data Standards, and Data Quality; Biostatistics and Design Core; Patient-Reported Outcomes; Health Care Systems Interactions; Regulatory/Ethics; and Stakeholder Engagement. The goal of this article is to summarize the Biostatistics and Design Core's lessons learned during the initial pilot phase with seven pragmatic clinical trials conducted between 2012 and 2014. Methodological issues arose from the five cluster-randomized trials, also called group-randomized trials, including consideration of crossover and stepped wedge designs. We outlined general themes and challenges and proposed solutions from the pilot phase including topics such as study design, unit of randomization, sample size, and statistical analysis. Our findings are applicable to other pragmatic clinical trials conducted within health care systems. Pragmatic clinical trials using the UH2/UH3 funding mechanism provide an opportunity to ensure that all relevant design issues have been fully considered in order to reliably and efficiently evaluate new interventions and treatments. The integrity and generalizability of trial results can only be ensured if rigorous designs and appropriate analysis choices are an essential part of their research protocols. © The Author(s) 2016.

Identifying content for the glaucoma-specific item bank to measure quality-of-life parameters.

PubMed

Khadka, Jyoti; McAlinden, Colm; Craig, Jamie E; Fenwick, Eva K; Lamoureux, Ecosse L; Pesudovs, Konrad

2015-01-01

Patient-reported outcomes (PROs) have become essential clinical trial end points. However, a comprehensive, multidimensional, patient-relevant, and precise glaucoma-specific PRO instrument is not available. Therefore, the purpose of this study was to identify content for a new, glaucoma-specific, quality-of-life (QOL) item bank. Content identification was undertaken in 5 phases: (1) identification of extant items in glaucoma-specific instruments and the qualitative literature; (2) focus groups and interviews with glaucoma patients; (3) item classification and selection; (4) expert review and revision of items; and (5) cognitive interviews with patients. A total of 737 unique items (extant items from PRO instruments, 247; qualitative articles, 14 items; focus groups and semistructured interviews, 476 items) were identified. These items were classified into 10 QOL domains. Four criteria (item redundancy, item inconsistent with domain definition, item content too narrow to have wider applicability, and item clarity) were used to remove and refine the items. After the cognitive interviews, the final minimally representative item set had a total of 342 unique items belonging to 10 domains: activity limitation (88), mobility (20), visual symptoms (19), ocular surface symptoms (22), general symptoms (15), convenience (39), health concerns (45), emotional well-being (49), social issues (23), and economic issues (22). The systematic content identification process identified 10 QOL domains, which were important to patients with glaucoma. The majority of the items were identified from the patient-specific focus groups and semistructured interviews suggesting that the existing PRO instruments do not adequately address QOL issues relevant to individuals with glaucoma.

Public participation in decision-making on the coverage of new antivirals for hepatitis C.

PubMed

Kieslich, Katharina; Ahn, Jeonghoon; Badano, Gabriele; Chalkidou, Kalipso; Cubillos, Leonardo; Hauegen, Renata Curi; Henshall, Chris; Krubiner, Carleigh B; Littlejohns, Peter; Lu, Lanting; Pearson, Steven D; Rid, Annette; Whitty, Jennifer A; Wilson, James

2016-08-15

Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance considerations of innovation, clinical evidence, budget impact and equity in health priority-setting. The purpose of this paper is to examine the role of public participation in addressing these considerations. Design/methodology/approach - The paper employs a comparative case study approach. It explores the experience of four countries - Brazil, England, South Korea and the USA - in making coverage decisions about the antiviral sofosbuvir and involving the public and patients in these decision-making processes. Findings - Issues emerging from public participation ac tivities include the role of the universal right to health in Brazil, the balance between innovation and budget impact in England, the effect of unethical medical practices on public perception in South Korea and the legitimacy of priority-setting processes in the USA. Providing policymakers are receptive to these issues, public participation activities may be re-conceptualized as processes that illuminate policy problems relevant to a particular context, thereby promoting an agenda-setting role for the public. Originality/value - The paper offers an empirical analysis of public involvement in the case of sofosbuvir, where the relevant considerations that bear on priority-setting decisions have been particularly stark. The perspectives that emerge suggest that public participation contributes to raising attention to issues that need to be addressed by policymakers. Public participation activities can thus contribute to setting policy agendas, even if that is not their explicit purpose. However, the actualization of this contribution is contingent on the receptiveness of policymakers.

The Clinical Neuroscience Course: Viewing Mental Health from Neurobiological Perspectives

PubMed Central

Lambert, Kelly G.

2005-01-01

Although the field of neuroscience is booming, a challenge for researchers in mental health disciplines is the integration of basic research findings into applied clinical approaches leading to effective therapies. Recently the National Institute of Mental Health called for translational research grants to encourage collaboration between neuroscientists and mental health professionals. In order for this “clinical neuroscience” to emerge and thrive, an important first step is the provision of appropriate course offerings so that future neuroscience researchers and mental health practitioners will have a common neurobiological base from which to make informed decisions about the most efficacious treatments for mental illnesses. Accordingly, an integrative course, Clinical Neuroscience, was developed to address these issues. After reviewing the historical origins of this emerging discipline, students are exposed to fundamental overviews of neuroanatomy, neurochemistry, and neural development before approaching the neurobiological components of several disorders (e.g., schizophrenia, depression, Tourette’s syndrome, drug abuse, obsessive compulsive disorder). Finally, the maintenance of mental health is emphasized as topics such as psychoneuroimmunology, coping with stress, and eating regulation are discussed. Important themes emphasized in this course include (1) the consideration of only empirically based evidence, (2) the view that mental illness represents a disruption of neurobiological homeostasis, (3) the acknowledgement that, because the brain is a plastic organ, the clinical relevance of environmental and behavioral influences is difficult to overestimate, and (4) the recognition of the value of ecologically relevant animal models in the investigation of various aspects of mental illness. Because of the importance of stress maintenance in mental health, exercises have been developed to increase students’ awareness of their own coping strategies. Finally, several books and movies are incorporated to provide additional points of view of the topics discussed in the course. PMID:23494100

Application of the Stable Isotope Label Approach in Clinical Development-Supporting Dissolution Specifications for a Commercial Tablet Product with Tafenoquine, a Long Half-life Compound.

PubMed

Goyal, Navin; Mohamed, Khadeeja; Rolfe, Katie; Sahota, Satty; Ernest, Terry; Duparc, Stephan; Taylor, Maxine; Casillas, Linda; Koh, Gavin C K W

2018-06-04

Bioavailability/bioequivalence studies supporting clinical drug development or commercial supply of drug formulations are often time, cost, and resource intensive. The drug's pharmacokinetic (PK) variability, systemic half-life, and safety issues may pose additional challenges. The stable isotope label (SIL) approach provides a useful tool to significantly reduce the study size in clinical PK studies. Tafenoquine (TQ) is an 8-aminoquinoline under development for preventing Plasmodium vivax malaria relapse. This SIL study assessed the impact of differences in the in vitro dissolution profiles on in vivo exposure of TQ tablets. Fourteen healthy volunteers received a single dose of 300 mg TQ Intermediate Aged or 300 mg TQ Control formulations in this single-center, two-arm, randomized, open-label, parallel-group study. Endpoints included the geometric means ratio of the area under the concentration-time curve (AUC (0-t) and AUC (0-∞) ; primary endpoint) and maximum plasma concentration (C max ) for Intermediate Aged versus Control TQ; correlation of PK parameters for venous versus peripheral (via microsample) blood samples; and safety and tolerability endpoints. Geometric mean ratios for PK parameters (AUC and C max ) and their 90% confidence intervals fell well within standard bioequivalence limits (0.80-1.25). Only one mild adverse event (skin abrasion) was reported. In summary, this SIL methodology-based study demonstrates that the observed differences in the in vitro dissolution profiles between the Control and Intermediate Aged TQ tablets have no clinically relevant effect on systemic TQ exposure. The SIL approach was successfully implemented to enable the setting of a clinically relevant dissolution specification. This study (GSK study number 201780) is registered at clinicaltrials.gov with identifier NCT02751294.

Mobile phone interference with medical equipment and its clinical relevance: a systematic review.

PubMed

Lawrentschuk, Nathan; Bolton, Damien M

2004-08-02

To conduct a systematic review of studies on clinically relevant digital mobile phone electromagnetic interference with medical equipment. MEDLINE and SUMSEARCH were searched for the period 1966-2004. The Cochrane Library and Database of Abstracts of Reviews of Effects were also searched for systematic reviews. Studies were eligible if published in a peer-reviewed journal in English, and if they included testing of digital mobile phones for clinically relevant interference with medical equipment used to monitor or treat patients, but not implantable medical devices. As there was considerable heterogeneity in medical equipment studied and the conduct of testing, results were summarised rather than subjected to meta-analysis. Clinically relevant electromagnetic interference (EMI) secondary to mobile phones potentially endangering patients occurred in 45 of 479 devices tested at 900 MHz and 14 of 457 devices tested at 1800 MHz. However, in the largest studies, the prevalence of clinically relevant EMI was low. Most clinically relevant EMI occurred when mobile phones were used within 1 m of medical equipment. Although testing was not standardised between studies and equipment tested was not identical, it is of concern that at least 4% of devices tested in any study were susceptible to clinically relevant EMI. All studies recommend some type of restriction of mobile phone use in hospitals, with use greater than 1 m from equipment and restrictions in clinical areas being the most common.

Web-based international studies in limited populations of pediatric leukemia.

PubMed

Valsecchi, Maria Grazia; Silvestri, Daniela; Covezzoli, Anna; De Lorenzo, Paola

2008-02-01

Recent progress in cancer research leads to the characterization of small subgroups of patients by genetic/biological features. Clinical studies in this setting are frequently promoted by international networks of independent researchers and are limited by practical and methodological constraints, not least the regulations recently issued by national and international institutions (EU Directive 2001/20/EC). We reviewed various methods in the design of international multicenter studies, with focus on randomized clinical trials. This paper reports our experience in planning and conducting international studies in childhood leukemia. We applied a decentralized study conduct based on a two-level structure, comprising a national and an international coordinating level. For the more recent trials this structure was implemented as a web-based system. This approach accommodates major legal requirements (e.g., safety reporting) and ensures Good Clinical Practice principles by implementing risk-oriented monitoring procedures. Setting up international non-commercial trials is increasingly complicated. Still, they are strongly needed for answering relevant questions in limited populations. (c) 2007 Wiley-Liss, Inc.

Performance validity testing in neuropsychology: a clinical guide, critical review, and update on a rapidly evolving literature.

PubMed

Lippa, Sara M

2018-04-01

Over the past two decades, there has been much research on measures of response bias and myriad measures have been validated in a variety of clinical and research samples. This critical review aims to guide clinicians through the use of performance validity tests (PVTs) from test selection and administration through test interpretation and feedback. Recommended cutoffs and relevant test operating characteristics are presented. Other important issues to consider during test selection, administration, interpretation, and feedback are discussed including order effects, coaching, impact on test data, and methods to combine measures and improve predictive power. When interpreting performance validity measures, neuropsychologists must use particular caution in cases of dementia, low intelligence, English as a second language/minority cultures, or low education. PVTs provide valuable information regarding response bias and, under the right circumstances, can provide excellent evidence of response bias. Only after consideration of the entire clinical picture, including validity test performance, can concrete determinations regarding the validity of test data be made.

“Smart Forms” in an Electronic Medical Record: Documentation-based Clinical Decision Support to Improve Disease Management

PubMed Central

Schnipper, Jeffrey L.; Linder, Jeffrey A.; Palchuk, Matvey B.; Einbinder, Jonathan S.; Li, Qi; Postilnik, Anatoly; Middleton, Blackford

2008-01-01

Clinical decision support systems (CDSS) integrated within Electronic Medical Records (EMR) hold the promise of improving healthcare quality. To date the effectiveness of CDSS has been less than expected, especially concerning the ambulatory management of chronic diseases. This is due, in part, to the fact that clinicians do not use CDSS fully. Barriers to clinicians' use of CDSS have included lack of integration into workflow, software usability issues, and relevance of the content to the patient at hand. At Partners HealthCare, we are developing “Smart Forms” to facilitate documentation-based clinical decision support. Rather than being interruptive in nature, the Smart Form enables writing a multi-problem visit note while capturing coded information and providing sophisticated decision support in the form of tailored recommendations for care. The current version of the Smart Form is designed around two chronic diseases: coronary artery disease and diabetes mellitus. The Smart Form has potential to improve the care of patients with both acute and chronic conditions. PMID:18436911

An update on insertable cardiac monitors: examining the latest clinical evidence and technology for arrhythmia management.

PubMed

Olsen, Flemming J; Biering-Sørensen, Tor; Krieger, Derk W

2015-05-01

Continuous cardiac rhythm monitoring has undergone compelling progress over the past decades. Cardiac monitoring has emerged from 12-lead electrocardiograms being performed at the discretion of the treating physician to in-hospital telemetry, Holter monitoring, prolonged external event monitoring and most recently toward insertable device monitoring for several years. Significant advantages and disadvantages pertaining to these monitoring options will be addressed in this review. Insertable cardiac monitors have several advantages over external monitoring techniques and may signify a clinical turning point in the field of arrhythmia management. However, their role in the detection of paroxysmal atrial fibrillation after cryptogenic strokes has yet to evolve. This will be the main focus of this review. Issues surrounding patient selection, clinical relevance and determination of cost-effectiveness for prolonged cardiac monitoring require further studies. Furthermore, insertable cardiac monitoring has not only the potential to augment diagnostic capabilities but also to improve the management of paroxysmal atrial fibrillation.

Development and evaluation of an electronic health record configuration and customization laboratory course for clinical informatics students.

PubMed

Mohan, Vishnu; Hersh, William R

2013-01-01

There is a need for informatics educational programs to develop laboratory courses that facilitate hands-on access to an EHR, and allow students to learn and evaluate functionality and configuration options. This is particularly relevant given the diversity of backgrounds of informatics students. We implemented an EHR laboratory course that allowed students to explore an EHR in both inpatient and outpatient clinical environments. The course focused on specific elements of the EHR including order set development, customization, clinical decision support, ancillary services, and billing and coding functionality. Students were surveyed at the end of the course for their satisfaction with the learning experience. We detailed challenges as well as lessons learned after analyzing student evaluations of this course. Features that promote the successful offering of an online EHR course, include (1) using more than one EHR to allow students to compare functionalities, (2) ensuring appropriate course calibration, (3) countering issues specific to EHR usability, and (4) fostering a fertile environment for rich online conversations are discussed.

"Smart Forms" in an Electronic Medical Record: documentation-based clinical decision support to improve disease management.

PubMed

Schnipper, Jeffrey L; Linder, Jeffrey A; Palchuk, Matvey B; Einbinder, Jonathan S; Li, Qi; Postilnik, Anatoly; Middleton, Blackford

2008-01-01

Clinical decision support systems (CDSS) integrated within Electronic Medical Records (EMR) hold the promise of improving healthcare quality. To date the effectiveness of CDSS has been less than expected, especially concerning the ambulatory management of chronic diseases. This is due, in part, to the fact that clinicians do not use CDSS fully. Barriers to clinicians' use of CDSS have included lack of integration into workflow, software usability issues, and relevance of the content to the patient at hand. At Partners HealthCare, we are developing "Smart Forms" to facilitate documentation-based clinical decision support. Rather than being interruptive in nature, the Smart Form enables writing a multi-problem visit note while capturing coded information and providing sophisticated decision support in the form of tailored recommendations for care. The current version of the Smart Form is designed around two chronic diseases: coronary artery disease and diabetes mellitus. The Smart Form has potential to improve the care of patients with both acute and chronic conditions.

A Logic-Based Psychotherapy Approach to Treating Patients Which Focuses on Faultless Logical Functioning: A Case Study Method

PubMed Central

Almeida, Fernando; Moreira, Diana

2017-01-01

Many clinical patients present to mental health clinics with depressive symptoms, anxiety, psychosomatic complaints, and sleeping problems. These symptoms which originated may originate from marital problems, conflictual interpersonal relationships, problems in securing work, and housing issues, among many others. These issues might interfere which underlie the difficulties that with the ability of the patients face in maintaining faultless logical reasoning (FLR) and faultless logical functioning (FLF). FLR implies to assess correctly premises, rules, and conclusions. And FLF implies assessing not only FLR, but also the circumstances, life experience, personality, events that validate a conclusion. Almost always, the symptomatology is accompanied by intense emotional changes. Clinical experience shows that a logic-based psychotherapy (LBP) approach is not practiced, and that therapists’ resort to psychopharmacotherapy or other types of psychotherapeutic approaches that are not focused on logical reasoning and, especially, logical functioning. Because of this, patients do not learn to overcome their reasoning and functioning errors. The aim of this work was to investigate how LBP works to improve the patients’ ability to think and function in a faultless logical way. This work describes the case studies of three patients. For this purpose we described the treatment of three patients. With this psychotherapeutic approach, patients gain knowledge that can then be applied not only to the issues that led them to the consultation, but also to other problems they have experienced, thus creating a learning experience and helping to prevent such patients from becoming involved in similar problematic situations. This highlights that LBP is a way of treating symptoms that interfere on some level with daily functioning. This psychotherapeutic approach is relevant for improving patients’ quality of life, and it fills a gap in the literature by describing original case analyses. PMID:29312088

Connecting pre-marketing clinical research and medical practice: opinion-based study of core issues and possible changes in drug regulation.

PubMed

Wieringa, Nicolien F; Peschar, Jules L; Denig, Petra; de Graeff, Pieter A; Vos, Rein

2003-01-01

To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for dosing this gap. Interviews with 47 physicians and pharmacists who were liaised to drug regulation through their role in the pre- and post-marketing shaping of new cardiovascular drugs. Data were analyzed using methods of grounded theory and analytical evaluations. Six core issues were identified that referred to the standards in drug regulation, the organization of the regulatory system, and conflicting interests. Pre-marketing trials should focus more on populations and research questions relevant to medical practice. In particular, variability in drug responses between subgroups of patients and demonstration of effectiveness should become major principles in drug regulation. An interactive post-marketing process in which public interests are represented was considered necessary to further guide research and development according to the needs in daily practice. Strategies for change could be applied within the present system of drug regulation, or affect its basic principles. Regulatory authorities were primarily identified to initiate changes, but many other parties should be involved. Barriers for change were identified regarding differences in interests between parties, organizational matters, and with respect to broader healthcare policies. Based on the respondents' opinions, there is a need to focus regulatory standards more on the needs in medical practice. Therefore, regulatory authorities should further develop their influence in the pre- and post-marketing drug development process, together with other parties involved, in order to bridge the gap between clinical research and medical practice.

Do the Trajectories of Bipolar Disorder and Schizophrenia Follow a Universal Staging Model?

PubMed

Duffy, Anne; Malhi, Gin S; Grof, Paul

2017-02-01

The purpose of this study is to address the question of whether a universal staging model of severe psychiatric disorders is a viable direction for future research by examining the extant literature. A narrative review was conducted of the relevant historical, conceptual, and empirical literature pertaining to the clinical trajectory of bipolar disorder and schizophrenia and issues relevant to staging. There is substantive evidence that classic recurrent bipolar disorder is separable from schizophrenia on the basis of family history, developmental and clinical course, treatment response, and neurobiological findings. However, because of the intrinsic heterogeneity of diagnostic categories that has been amplified by recent changes in psychiatric taxonomy, key distinctions between the groups have become obfuscated. While mapping risk and illness markers to emerging psychopathology is a logical approach and may be of value for some psychiatric disorders and/or their clinical subtypes, robust evidence supporting identifiable stages per se is still lacking. Presently, even rudimentary stages such as prodromes cannot be meaningfully applied across different disorders and no commonalities can be found for the basis of universal staging. Advances in the prediction of risk, accurate early illness detection, and tailored intervention will require mapping biomarkers and other risk indicators to reliable clinical phases of illness progression. Given the capricious nature of mood and psychotic disorders, this task is likely to yield success only if conducted in narrowly defined subgroups of individuals at high risk for specific illnesses. This approach is diametrically opposite to that being promulgated by proponents of a universal staging model.

Bridging the gap between the neurocognitive lab and the addiction clinic.

PubMed

Franken, Ingmar H A; van de Wetering, Ben J M

2015-05-01

In the past decennium there has been an enormous increase in new insights in cognitive mechanisms of addiction and their neural substrates. These candidate neurocognitive mechanisms, particularly those associated with "drive" and "control" aspects of addiction, are clearly involved in substance use problems but do not yet provide a full explanation. The neurocognitive mechanisms addressed in the present perspective are attentional bias, reward processing (both drive aspects) and error-processing and cognitive control (both control aspects). The time has come to transfer these recent insights more consistently to clinical practice by studying their relevance for diagnosis and treatment in patient samples. The present perspective echoes the development of recent initiatives such as the RDoC system to integrate developments in neuroscience into clinical practice. The aim of this article is to open new vistas for addiction diagnosis and treatment and to discuss why and how these neurocognitive aspects of addictive behavior can be used in clinical practice. In addition, present problematic issues and a future research agenda are provided. Copyright © 2014 Elsevier Ltd. All rights reserved.