Autism: Clinical and Research Issues.

ERIC Educational Resources Information Center

Accardo, Pasquale J., Ed.; Magnusen, Christy, Ed.; Capute, Arnold J., Ed.

This text examines the characteristics that define autism: impairments in communication; abnormal social development; and clinically significant odd behaviors. Specific chapters include: (1) Neural Mechanisms in Autism (Andrew W. Zimmerman and Barry Gordon); (2) Epidemiology of Autism and Other Pervasive Developmental Disorders: Current…

Balancing Ethical Pros and Cons of Stem Cell Derived Gametes.

PubMed

Segers, Seppe; Mertes, Heidi; de Wert, Guido; Dondorp, Wybo; Pennings, Guido

2017-07-01

In this review we aim to provide an overview of the most important ethical pros and cons of stem cell derived gametes (SCD-gametes), as a contribution to the debate about reproductive tissue engineering. Derivation of gametes from stem cells holds promising applications both for research and for clinical use in assisted reproduction. We explore the ethical issues connected to gametes derived from embryonic stem cells (both patient specific and non-patient specific) as well as those related to gametes derived from induced pluripotent stem cells. The technology of SCD-gametes raises moral concerns of how reproductive autonomy relates to issues of embryo destruction, safety, access, and applications beyond clinical infertility.

A mixed methods approach to adapting health-related quality of life measures for use in routine oncology clinical practice.

PubMed

Harley, Clare; Takeuchi, Elena; Taylor, Sally; Keding, Ada; Absolom, Kate; Brown, Julia; Velikova, Galina

2012-04-01

The current study reviewed and adapted existing health-related quality of life (HRQoL) instruments for use in routine clinical practice delivering outpatient chemotherapy for colorectal, breast and gynaecological cancers. 564 (288 gynaecological, 208 breast and 68 colorectal) outpatient consultations of 141 patients were audio-recorded and analysed to identify discussed issues. Issues were ranked from most to least commonly discussed within each disease group. Existing HRQoL instruments were evaluated against these lists and best fitting items entered into cancer-specific item banks. Item banks were evaluated during semi-structured interviews by twenty-one oncologists (13 consultants and 8 specialist registrars), four clinical nurse specialists and thirty patients, from breast, gynaecological and colorectal cancer practices. Pilot questionnaires were completed by 448 (145 breast, 148 gynaecological and 155 colorectal) patients attending outpatient clinics. Item selection and scale reliability was explored using descriptive data and psychometric methods alongside qualitative patient and clinician ratings. Each questionnaire includes five physical and three psychosocial function scales each with good internal consistency reliability (α > 0.70) plus disease-specific individual-symptom items identified as useful in clinical practice. Three cancer-specific health-related quality of life measures were developed for use in routine clinical practice. Initial analyses suggest good clinical utility and acceptable psychometric properties for the new instruments.

Some design issues in trials of microbicides for the prevention of HIV infection.

PubMed

Fleming, Thomas R; Richardson, Barbra A

2004-08-15

Trials for the prevention of human immunodeficiency virus (HIV) infection that evaluate microbicides provide significant design challenges. Three of these design issues deserve more careful consideration. The first issue relates to the benefits of using both blinded and unblinded control groups when the placebo regimen may not be inert and when the effectiveness of an intervention heavily depends on behavioral, as well as biological, factors. The second issue relates to the strength of evidence required for regulatory approval for the marketing of drugs and biologics when only a single pivotal phase 3 clinical trial has provided such evidence. The third issue relates to the appropriate next step after the completion of phase 1 trials, as well as the specific merits of conducting phase 2b screening trials that assess the effects on the same clinical efficacy end point that will be the primary end point in a phase 3 trial. The issues considered in microbicide trials for the prevention of HIV infection are also of importance in many other clinical scenarios.

Introduction to special issue: moving forward in pediatric neuropsychology.

PubMed

Daly, Brian P; Giovannetti, Tania; Zabel, T Andrew; Chute, Douglas L

2011-08-01

This special issue of The Clinical Neuropsychologist focuses on advances in the emerging subspecialty of pediatric neuropsychology. The national and international contributions in this issue cover a range of key clinical, research, training, and professional issues specific to pediatric neuropsychology. The genesis for this project developed out of a series of talks at the Philadelphia Pediatric Neuropsychology Symposium in 2010, hosted by the Stein Family Fellow, the Department of Psychology of the College of Arts and Sciences at Drexel University, and the Philadelphia Neuropsychology Society. Articles that explore clinical practice issue focus on the assessment of special medical populations with congenital and/or acquired central nervous system insults. Research articles investigate the core features of developmental conditions, the use of technology in neuropsychological research studies, and large sample size genomic, neuropsychological, and imaging studies of under-represented populations. The final series of articles examine new considerations in training, advocacy, and subspecialty board certification that have emerged in pediatric neuropsychology. This introductory article provides an overview of the articles in this special issue and concluding thoughts about the future of pediatric neuropsychology.

Enhancing international medical graduates' communication: the contribution of applied linguistics.

PubMed

Dahm, Maria R; Yates, Lynda; Ogden, Kathryn; Rooney, Kim; Sheldon, Brooke

2015-08-01

International medical graduates (IMGs) make up one-third of the Australian medical workforce. Those from non-English-language backgrounds can face cultural and communication barriers, yet linguistic support is variable and medical educators are often required to provide feedback on both medical and communication issues. However, some communication difficulties may be very specific to the experiences of IMGs as second language users. This interdisciplinary study combines perspectives from applied linguistics experts and clinical educators to address IMGs' difficulties from multiple dimensions and to enhance feedback quality. Five video-recorded patient encounters with five IMGs were collected at Launceston General Hospital. Three clinical educators gave quantitative and qualitative feedback using the Rating Instrument for Clinical Consulting Skills, and two applied linguistics experts analysed the data for language, pragmatic and communication difficulties. The comparison of the educators' language-related feedback with linguistic analyses of the same interactions facilitated the exploration of differences in the difficulties identified by the two expert groups. Although the clinical educators were able to use their tacit intuitive understanding of communication issues to identify IMG difficulties, they less frequently addressed the underlying issues or suggested specific remedies in their feedback. This pilot study illustrates the effectiveness of interdisciplinary collaboration in highlighting the specific discourse features contributing to IMG communication difficulties and thus assists educators in deconstructing their intuitive knowledge. The authors suggest that linguistic insights can therefore improve communications training by assisting educators to provide more targeted feedback. © 2015 John Wiley & Sons Ltd.

[Clinical practice guidelines: juridical and medico legal issues in health care malpractice liability].

PubMed

Moreschi, Carlo; Broi, Ugo Da

2014-01-01

Clinical Practice Guidelines are clinical tools addressed to medical and health professionals and are normally employed to improve quality and safety of diagnostic and therapeutical procedures but may sometimes limit the autonomy of medical and other health care professionals. The adherence to Clinical Practice Guidelines should not be an exclusive step to evaluate the liability and respect of standards of care in case of medico-legal investigations being each clinical case very specific. Medical liability and respect of standards of care should be evaluated with the support of Clinical Practice Guidelines and the extensive examination of all specific features, professional background and experience requested to treat each single patient.

Social Work Practice with LGBT Elders at End of Life: Developing Practice Evaluation and Clinical Skills Through a Cultural Perspective.

PubMed

Arthur, Darren P

2015-01-01

This article focuses on culturally sensitive clinical issues related to best practices with lesbian, gay, bisexual, transgender (LGBT) elder patients at end-of-life (EOL) at key points in the therapeutic relationship. Vital concepts, including practice evaluation and clinical skills, are presented through a cultural and oncology lens. There is a paucity of LGBT research and literature as well as a shortfall of MSW graduate school education specific to social work palliative and end-of-life care (PELC) practice with LGBT elders. The content of this article is designed to be adapted and used as an educational tool for institutions, agencies, graduate programs, medical professions, social work, and students. Learning the unique elements of LGBT cultural history and their implications on EOL care can improve social work practice. This article provides an examination from assessment and engagement basics to advance care planning incorporating specific LGBT EOL issues.

Social Justice: A Long-Term Challenge for Counseling Psychology

ERIC Educational Resources Information Center

Ivey, Allen E.; Collins, Noah M.

2003-01-01

Counseling psychology has a long history of interest and commitment to social justice and multicultural issues. This article discusses some of that history and, in addition, speaks to specifics of implementing a liberation psychology frame of reference into clinical practice along with the issues of implementation and challenges faced by those of…

Genetics objective structured clinical exams at the Maimonides Infants & Children's Hospital of Brooklyn, New York.

PubMed

Altshuler, Lisa; Kachur, Elizabeth; Krinshpun, Shifra; Sullivan, Deborah

2008-11-01

In 2003, the Maimonides Infants & Children's Hospital received a Title VII Residency Training in Primary Care grant to integrate genetic-specific competencies into postgraduate pediatrics education. As part of that endeavor, mandatory yearly genetics objective structured clinical exams (OSCEs) were instituted for third-year residents. This article reports on the first three years of experience with this innovative educational tool.After an overview of genetic concepts, dysmorphology, and communication styles, residents complete a five-station OSCE and receive feedback from standardized patients and from the faculty who observe them. After this clinical exercise, the residents participate in a small-group debriefing session to share strategies for effective communication and clinical case management and to discuss the ethical issues that arise with these genetic cases.In three years, 60 residents have completed the genetics OSCE program. Evaluation data demonstrate that the program has been effective in both introducing genetic-specific challenges and assessing residents' clinical skills. It has helped trainees self-identify both strengths and further training needs. Pre- and postsurveys among the trainees show increased comfort levels in performing 5 of 12 genetic-related clinical tasks.We conclude that genetics OSCEs are an enriching educational tool. Merely providing trainees and practicing physicians with the latest scientific information is unlikely to prepare them for counseling patients about complex genetic issues. Developing proficiency requires focused practice and effective feedback.This article is part of a theme issue of Academic Medicine on the Title VII health professions training programs.

Common Elements in Rare Kidney Diseases: Conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.

PubMed

Aymé, Ségolène; Bockenhauer, Detlef; Day, Simon; Devuyst, Olivier; Guay-Woodford, Lisa M; Ingelfinger, Julie R; Klein, Jon B; Knoers, Nine V A M; Perrone, Ronald D; Roberts, Julia; Schaefer, Franz; Torres, Vicente E; Cheung, Michael; Wheeler, David C; Winkelmayer, Wolfgang C

2017-10-01

Rare kidney diseases encompass at least 150 different conditions, most of which are inherited. Although individual rare kidney diseases raise specific issues, as a group these rare diseases can have overlapping challenges in diagnosis and treatment. These challenges include small numbers of affected patients, unidentified causes of disease, lack of biomarkers for monitoring disease progression, and need for complex care. To address common clinical and patient issues among rare kidney diseases, the KDIGO Controversies Conference entitled, Common Elements in Rare Kidney Diseases, brought together a panel of multidisciplinary clinical providers and patient advocates to address five central issues for rare kidney diseases. These issues encompassed diagnostic challenges, management of kidney functional decline and progression of chronic kidney disease, challenges in clinical study design, translation of advances in research to clinical care, and provision of practical and integrated patient support. Thus, by a process of consensus, guidance for addressing these challenges was developed and is presented here. Copyright © 2017 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

Dual-Energy CT: New Horizon in Medical Imaging

PubMed Central

Goo, Jin Mo

2017-01-01

Dual-energy CT has remained underutilized over the past decade probably due to a cumbersome workflow issue and current technical limitations. Clinical radiologists should be made aware of the potential clinical benefits of dual-energy CT over single-energy CT. To accomplish this aim, the basic principle, current acquisition methods with advantages and disadvantages, and various material-specific imaging methods as clinical applications of dual-energy CT should be addressed in detail. Current dual-energy CT acquisition methods include dual tubes with or without beam filtration, rapid voltage switching, dual-layer detector, split filter technique, and sequential scanning. Dual-energy material-specific imaging methods include virtual monoenergetic or monochromatic imaging, effective atomic number map, virtual non-contrast or unenhanced imaging, virtual non-calcium imaging, iodine map, inhaled xenon map, uric acid imaging, automatic bone removal, and lung vessels analysis. In this review, we focus on dual-energy CT imaging including related issues of radiation exposure to patients, scanning and post-processing options, and potential clinical benefits mainly to improve the understanding of clinical radiologists and thus, expand the clinical use of dual-energy CT; in addition, we briefly describe the current technical limitations of dual-energy CT and the current developments of photon-counting detector. PMID:28670151

The administration of music therapy training clinics: a descriptive study.

PubMed

Abbott, Elaine A

2006-01-01

A two-part study was conducted to describe issues and administrative practices related to university and college affiliated music therapy training clinics. First, all 72 AMTA academic directors were surveyed in order to discover (a) which programs had a clinic, and (b) the reasons why other directors did not operate a clinic. Second, 12 survey respondents, who reported that they were involved with a training clinic, participated in in-depth interviews discussing: (a) their motivations for establishing a clinic, (b) the possible effects of a clinic on the community, (c) the individuals and groups involved in clinic operations, d) clinic space and equipment, (e) policy and procedure topics, (f) specific administrative practices related to clients and students, (g) finances, (h) research (i) quality assurance, (j) dual roles, and (k) liability issues. The administrative practices described by the interviewees varied greatly across clinics and provided a wealth of information that could be considered both useful and thought provoking for those interested in operating a music therapy clinic.

An Inexpensive Family Index of Risk for Mood Issues Improves Identification of Pediatric Bipolar Disorder

PubMed Central

Algorta, Guillermo Perez; Youngstrom, Eric A.; Phelps, James; Jenkins, Melissa M.; Kogos, Jennifer L.; Findling, Robert L.

2013-01-01

Family history of mental illness provides important information when evaluating pediatric bipolar disorder (PBD). However, such information is often challenging to gather within clinical settings. This study investigates the feasibility and utility of gathering family history information using an inexpensive method practical for outpatient settings. Families (N=273) completed family history, rating scales, MINI and KSADS interviews about youths 5–18 (median=11) years presenting to an outpatient clinic. Primary caregivers completed a half page Family Index of Risk for Mood issues (FIRM). All families completed the FIRM quickly and easily. Most (78%) reported 1+ relatives having history of mood or substance issues, M=3.7 (SD=3.3). A simple sum of familial mood issues discriminated cases with PBD from all other cases, AUROC=.63, p=.006. FIRM scores were specific to youth mood disorder and not ADHD or disruptive behavior disorder. FIRM scores significantly improved the detection of PBD even controlling for rating scales. No subset of family risk items performed better than the total. Family history information showed clinically meaningful discrimination of PBD. Two different approaches to clinical interpretation showed validity in these clinically realistic data. Inexpensive and clinically practical methods of gathering family history can help to improve the detection of PBD. PMID:22800090

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.

Distinct management issues with Crohn's disease of the small intestine.

PubMed

Fong, Steven C M; Irving, Peter M

2015-03-01

Small bowel Crohn's disease can present with clinical challenges that are specific to its location. In this review, we address some of the areas that present particular problems in small bowel Crohn's disease. A key issue specific to small bowel Crohn's disease relates to its diagnosis given that access to the small bowel is limited. Radiological advances, particularly in small bowel ultrasonography and MRI, as well as the introduction of capsule endoscopy and balloon enteroscopy are helping to address this. In addition, our ability to differentiate small bowel Crohn's disease from other causes of inflammation, such as tuberculosis, is improving on the basis of better understanding of the features that differentiate these conditions. It is also becoming apparent that jejunal Crohn's disease represents a distinct disease phenotype with potentially worse clinical outcomes. Finally, because it is a rare complication, our understanding of small bowel cancer associated with Crohn's disease remains limited. Recent publications are, however, starting to improve our knowledge of this condition. Although small bowel Crohn's disease presents specific management issues not seen in patients with Crohn's disease elsewhere in the gastrointestinal tract, our knowledge of how to manage these is improving.

Ethical learning on international medical electives: a case-based analysis of medical student learning experiences.

PubMed

Bowsher, Gemma; Parry-Billings, Laura; Georgeson, Anna; Baraitser, Paula

2018-04-11

Students on international medical electives face complex ethical issues when undertaking clinical work. The variety of elective destinations and the culturally specific nature of clinical ethical issues suggest that pre-elective preparation could be supplemented by in-elective support. An online, asynchronous, case-based discussion was piloted to support ethical learning on medical student electives. We developed six scenarios from elective diaries to stimulate peer-facilitated discussions during electives. We evaluated the transcripts to assess whether transformative, experiential learning took place, assessing specifically for indications that 1) critical reflection, 2) reflective action and 3) reflective learning were taking place. We also completed a qualitative thematic content analysis of the discussions. Of forty-one extended comments, nine responses showed evidence of transformative learning (Mezirow stage three). The thematic analysis identified five themes: adopting a position on ethical issues without overt analysis; presenting issues in terms of their effects on students' ability to complete tasks; describing local contexts and colleagues as "other"; difficulty navigating between individual and structural issues, and overestimation of the impact of individual action on structures and processes. Results suggest a need to: frame ethical learning on elective so that it builds on earlier ethical programmes in the curriculum, and encourages students to adopt structured approaches to complex ethical issues including cross-cultural negotiation and to enhance global health training within the curriculum.

A Phenomenological Study: Community Mental Health Centers Leaders Influence on Clinician Effectiveness

ERIC Educational Resources Information Center

Williams, Beth B.

2011-01-01

Some clinical leaders of community mental health centers are not aware of successful methods for supporting and empowering staff to be more effective, specifically when the staff is experiencing change because of new health information technology. Clinical leaders in community mental health face similar management issues as do other business,…

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

PubMed Central

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-01-01

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

Financial Capacity and Financial Exploitation of Older Adults: Research Findings, Policy Recommendations and Clinical Implications

PubMed Central

Wood, Stacey; Lichtenberg, Peter A.

2017-01-01

Financial exploitation (FE) of older adults is a social issue that is beginning to receive the attention that it deserves in the media thanks to some high profile cases, but empirical research and clinical guidelines on the topic are just emerging. Our review describes the significance of the problem, proposes a theoretical model for conceptualizing FE, and summarizes related areas of research that may be useful to consider in the understanding of FE. We discuss structural issues that have limited interventions in the past and make specific public policy recommendations in light of the largest intergenerational transfer of wealth in history. Finally, we discuss implications for clinical practice. PMID:28452630

Regulation of immunotherapeutic products for cancer and FDA’s role in product development and clinical evaluation

PubMed Central

2013-01-01

Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated therapies is target specificity with a consequent reduction in off-target side effects. Recent scientific advances have led to clinical trials of both active and passive immunotherapeutic products that have the potential to convert life-ending diseases into chronic but manageable conditions. Clinical trials investigating immunotherapeutics are ongoing with some trials at advanced stages of development. However, as with many products involving novel mechanisms of action, major regulatory and scientific issues arising with clinical use of immunotherapeutic products remain to be addressed. In this review, we address issues related to different immunotherapeutics and provide recommendations for the characterization and evaluation of these products during various stages of product and clinical development. PMID:24764535

Issues Specific to Women

MedlinePlus

... VA for Vets Performance Based Interviewing Clinical Trainees (Academic Affiliations) Employees & Contractors Talent Management System (TMS) VA ... stress. Search Pilots Search PILOTS *, the largest citation database on PTSD. What is PILOTS? Subscribe Sign up ...

Gender issues in clinical dental education.

PubMed

Tiwana, Karen K; Kutcher, Mark J; Phillips, Ceib; Stein, Margot; Oliver, Jessica

2014-03-01

In spring 2011, a study was initiated to investigate the nature and extent of gender issues in clinical dental education at the University of North Carolina at Chapel Hill School of Dentistry. Surveys were sent to 236 dental students in the second, third, and fourth years; eighty-six (36.4 percent) responded. Surveys were also sent to seventy-one full-time dental faculty members who had clinical contact with students, and thirty-four (47.9 percent) responded. Of the student respondents, fifty-one were female and thirty-five were male; the faculty respondents were ten women and twenty-four men. A significantly greater proportion of female than male student respondents reported that issues related to gender affected clinical training. The female students also responded that mentorship was less available and less in content for them compared to males, and significantly more female than male students reported lower self-confidence in clinical settings. Among faculty respondents, a higher proportion of women than men reported insufficient awareness of gender issues. These faculty members also reported thinking that female students showed more empathy toward patients than males. Both faculty and student respondents said that female faculty members received less respect from students than did male faculty members. Forty-eight percent of the students reported experiencing or witnessing gender-based prejudice in clinical settings, and 7.0 percent reported experiencing or witnessing unwelcome sexual advances or conduct. A more robust study to include other dental institutions is needed. With confirmation of specific gender issues, corrective measures could be recommended to improve the climate for both females and males in the clinical component of dental education.

Implementation Considerations for Multisite Clinical Trials with Cognitive Neuroscience Tasks

PubMed Central

Keefe, Richard S. E.; Harvey, Philip D.

2008-01-01

Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are likely to be magnified in future studies when cognitive neuroscience (CN) procedures are explored in these trials, because in their current forms CN procedures are less standardized and more difficult to teach and monitor. For multisite trials, we anticipate that the most challenging issues will include assuring tester competence, monitoring tester performance, specific challenges with complex assessment methods, and having resources available for adequate monitoring of data quality. Suggestions for overcoming these implementation challenges are offered. PMID:18495645

The economic impact of poor sample quality in clinical chemistry laboratories: results from a global survey.

PubMed

Erdal, Erik P; Mitra, Debanjali; Khangulov, Victor S; Church, Stephen; Plokhoy, Elizabeth

2017-03-01

Background Despite advances in clinical chemistry testing, poor blood sample quality continues to impact laboratory operations and the quality of results. While previous studies have identified the preanalytical causes of lower sample quality, few studies have examined the economic impact of poor sample quality on the laboratory. Specifically, the costs associated with workarounds related to fibrin and gel contaminants remain largely unexplored. Methods A quantitative survey of clinical chemistry laboratory stakeholders across 10 international regions, including countries in North America, Europe and Oceania, was conducted to examine current blood sample testing practices, sample quality issues and practices to remediate poor sample quality. Survey data were used to estimate costs incurred by laboratories to mitigate sample quality issues. Results Responses from 164 participants were included in the analysis, which was focused on three specific issues: fibrin strands, fibrin masses and gel globules. Fibrin strands were the most commonly reported issue, with an overall incidence rate of ∼3%. Further, 65% of respondents indicated that these issues contribute to analyzer probe clogging, and the majority of laboratories had visual inspection and manual remediation practices in place to address fibrin- and gel-related quality problems (55% and 70%, respectively). Probe maintenance/replacement, visual inspection and manual remediation were estimated to carry significant costs for the laboratories surveyed. Annual cost associated with lower sample quality and remediation related to fibrin and/or gel globules for an average US laboratory was estimated to be $100,247. Conclusions Measures to improve blood sample quality present an important step towards improved laboratory operations.

A formative evaluation of problem-based learning as an instructional strategy in a medical laboratory technician course

NASA Astrophysics Data System (ADS)

Nelson, Diane Patricia

2002-09-01

This study is a formative evaluation of problem-based learning as an effective course delivery strategy in a second year introductory Medical Laboratory Technician discipline-specific hematology course. This strategy can serve two purposes in this type of course: discipline specific content knowledge and process skills learning. A needs study identified that students required additional workplace skills as they entered the clinical internship. Students tested well on the national registry examinations, discipline-specific content knowledge, but group process skills needed improvement in the areas of collaboration, communication, and critical reasoning. Problem-based learning was identified as an change intervention to help provide these skills. A search of the literature revealed that the Baker College cultural and physical environment would support this intervention. Twelve cases were written, situated in a clinical laboratory environment, addressing learning issues identified in a modified Delphi survey of laboratory personnel e.g. fiscal responsibility, turn-around time, invasiveness of laboratory techniques, and holistic view of healthcare environment. A hematology class of 13 students received the intervention. The cases were structured to proceed from instructor-centered (guided) learning issues to learner-centered learning issues. Observations of the in-group collaboration processes were documented, as well as oral presentations and critical reasoning, with students given periodic feedback on these skills. Student surveys provided data about satisfaction, attitude to PBL process, and self-efficacy. Multiple choice discipline-specific content examinations were given and compared with classes from the previous four years. The study found that students receiving the PBL treatment scored as well as or better than students from previous years on traditional multiple choice exams. Recall questions showed positive significance and application/analysis questions showed no significance from previous years. Clinical correlations end-of-case evaluations addressing the issues of thoroughness of investigation, supporting evidence, accuracy of information, order and clarity of thought showed positive improvement across the intervention, as did the PBL processes of in-group collaboration skills, teamwork skills, and presentation skills. By the end of the intervention, students expressed preference for student-centered learning issues.

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

Design Considerations For A Clinical XeC1 Excimer Laser Angioplasty System

NASA Astrophysics Data System (ADS)

Laudenslager, James B.; Goldenberg, Tsvi; Naghieh, Harry R.; Pham, Andrew A.; Narciso, Hugh L.; Tranis, Art; Pacala, Thomas J.

1989-09-01

Laser ablation and removal of intravascular plaque has long been a goal of physicians and physicists as an alternative treatment for coronary and peripheral artery disease. Early application of cw free light beam visible and infrared lasers such as argon ion or Nd:YAG lasers for this application were plagued by thermal side effects of the ablation process. Specifically, imprecise control of the boundary tissue injury produced by the deep penetration depth of the laser beam gave rise to early reclosure of the vessel due to the thermal nature of the ablation process. Pulsed ultraviolet laser free beam ablation of atherosclerotic plaque, however, does not produce thermal effects, cuts tissue precisely leaving a smooth wall and can ablate hard calcific lesions. We have chosen to develop a XeC1 excimer laser-fiberoptic delivery system for the clinical application of laser angioplasty based on achieving the desired therapeutic results for a laser revascularization procedure. Four major engineering design issues must be considered in order to produce a successful clinical laser angioplasty product. These engineering issues are: 1) Functional clinical engineering, 2) Regulatory design issues, 3) Hospital facility and user requirements, and 4) Economic issues for the manufacturer, the hospital and the patient.

A Healthy New World: Emergent Opportunities for Clinical Psychologists in the Patient Protection and Affordable Care Act

PubMed Central

Beidas, Rinad S.; Manderscheid, Ronald W.

2014-01-01

The Patient Protection and Affordable Care Act (ACA) is radically transforming the health and mental health care landscape. Emergent opportunities exist for clinical psychologists to redefine their role in healthcare. We reflect on the Chor and colleagues article (this issue) elucidating key issues for psychologists, and present additional recommendations for consideration. Specifically, we highlight three points: (1) moving beyond just training and hoping; (2) recovery, not just symptom reduction; and (3) it’s a healthy new world. Under each of these points, we suggest tactics for how to achieve these goals. PMID:24954983

Clinical experience with a high-performance ATM-connected DICOM archive for cardiology

NASA Astrophysics Data System (ADS)

Solomon, Harry P.

1997-05-01

A system to archive large image sets, such as cardiac cine runs, with near realtime response must address several functional and performance issues, including efficient use of a high performance network connection with standard protocols, an architecture which effectively integrates both short- and long-term mass storage devices, and a flexible data management policy which allows optimization of image distribution and retrieval strategies based on modality and site-specific operational use. Clinical experience with such as archive has allowed evaluation of these systems issues and refinement of a traffic model for cardiac angiography.

Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

PubMed

Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

2016-09-27

Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. 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/

New and Familiar Roles for Clinical Psychologists in the Effective Treatment for Children with an Autism Spectrum Disorder

ERIC Educational Resources Information Center

Gillis, Jennifer M.; Beights, Rebecca

2012-01-01

Alongside the increased prevalence of autism spectrum disorders (ASD), there is a greater likelihood of clinical psychologists having a role in the treatment of children with these disorders. Population heterogeneity with respect to ASD-specific symptomatology, comorbid medical and psychiatric issues, level of cognitive functioning, and presence…

Government regulations and other influences on the medical use of computers.

PubMed

Mishelevich, D J; Grams, R R; Mize, S G; Smith, J P

1979-01-01

This paper presents points brought out in a panel discussion held at the 12th Hawaiian International Conference on System Sciences, January 1979. The session was attended by approximately two dozen interested parties from various segments of the academic, government, and health care communities. The broad categories covered include the specific problems of government regulations and their impact on specific clinical information systems installed at The University of Texas Health Science Center at Dallas, opportunities in a regulated environment, problems in a regulated environment, vendor-related issues in the marketing and manufacture of computer-based information systems, rational approaches to government control, and specific issues related to medical computer science.

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.

Beyond research: a primer for considerations on using viral metagenomics in the field and clinic.

PubMed

Hall, Richard J; Draper, Jenny L; Nielsen, Fiona G G; Dutilh, Bas E

2015-01-01

Powered by recent advances in next-generation sequencing technologies, metagenomics has already unveiled vast microbial biodiversity in a range of environments, and is increasingly being applied in clinics for difficult-to-diagnose cases. It can be tempting to suggest that metagenomics could be used as a "universal test" for all pathogens without the need to conduct lengthy serial testing using specific assays. While this is an exciting prospect, there are issues that need to be addressed before metagenomic methods can be applied with rigor as a diagnostic tool, including the potential for incidental findings, unforeseen consequences for trade and regulatory authorities, privacy and cultural issues, data sharing, and appropriate reporting of results to end-users. These issues will require consideration and discussion across a range of disciplines, with inclusion of scientists, ethicists, clinicians, diagnosticians, health practitioners, and ultimately the public. Here, we provide a primer for consideration on some of these issues.

A comparison between findings from the DREEM questionnaire and that from qualitative interviews.

PubMed

Denz-Penhey, Harriet; Murdoch, J Campbell

2009-10-01

The Rural Clinical School of Western Australia educates one quarter of all Western Australian medical students in their first clinical year in rural settings. As part of a comprehensive evaluation programme students give feedback regularly. To identify if the Dundee Ready Education Environment Measurement (DREEM) data could be used qualitatively and descriptively to determine specific problems from the data alone despite the small numbers at some sites. The DREEM questionnaire was administered on the same day as qualitative interviews were undertaken. The qualitative interviews were analysed thematically first and then compared with findings from DREEM. Each major (student related) evaluation issue identified by the qualitative interviews was also identified by the DREEM questionnaire analysis. When the DREEM study was undertaken in the Rural Clinical School of Western Australia there was no real expectation that it would provide sufficient information to identify issues picked up in the extensive and time consuming qualitative study. About half of the work undertaken by the qualitative evaluation, that of the experiences of the students at the site, was picked up by the DREEM questionnaire in a much shorter time frame and at less cost of staff time and resources. The DREEM questionnaire can be used qualitatively to assess very specific issues relating to each of the subscales. These findings extend the use of DREEM from quantitative and statistically significant research to qualitative meaning-filled interpretations. The issues then need to be addressed sensitively.

Biosimilars and market access: a question of comparability and costs?

PubMed

Simoens, Steven; Verbeken, Gilbert; Huys, Isabelle

2012-12-01

This article discusses specific issues related to the market access of biosimilars. Biopharmaceuticals are complex molecules produced by living cells. Copies of these medicines, called biosimilars, are not identical to their reference medicine and therefore specific regulatory requirements apply. When considering the use of biosimilars, the question of the degree of comparability between a biosimilar and the reference biopharmaceutical needs to be considered for registration, pricing and reimbursement purposes in addition to the cost issue. To date, many key concepts (like clinically meaningful differences) remain undefined and the question of the degree of comparability is not yet resolved.

A decade of the Clinical Trials Transformation Initiative: What have we accomplished? What have we learned?

PubMed

Tenaerts, P; Madre, L; Landray, M

2018-02-01

The Clinical Trials Transformation Initiative reflects on 10 years of working to improve the quality and efficiency of clinical trials. This article highlights many of the Clinical Trials Transformation Initiative's accomplishments and offers examples of the impact that the Clinical Trials Transformation Initiative has had on the clinical trials enterprise. After conducting more than 25 projects and issuing recommendations for specific strategies to improve the design and execution of clinical trials, some common themes and lessons learned have emerged. Lessons include the importance of engaging many stakeholders, advanced planning to address critical issues, discontinuation of non-value added practices, and new opportunities presented by technology. Through its work, the Clinical Trials Transformation Initiative has also derived some operational best practices for conducting collaborative, multi-stakeholder projects covering project selection, project team dynamics and execution, and multi-stakeholder meetings and team discussions. Through these initiatives, the Clinical Trials Transformation Initiative has helped move the needle toward needed change in the clinical trials enterprise that has directly impacted stakeholders and patients alike.

Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.

PubMed

Shetty, Yashashri C; Saiyed, Aafreen A

2015-05-01

The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. Failure to protect subject safety and to report adverse events to IRBs was found to be significant compared to prior studies for clinical investigators, while failure to follow standard operating procedures and maintain documentation was noted as significant in warning letters to IRBs. Failure to maintain minutes of meeting and to follow written procedures for continuing review were new substantial violations in warning letters issued to IRBs. Forty-six warning letters were issued to sponsors, the most common violations being failure to follow a monitoring schedule (58.69%), failure to obtain investigator agreement (34.78%), failure to secure investigators' compliance (30.43%), and failure to maintain data records and ship documents to investigators (30.43%). Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide. 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.

Solution-focused conversations: a new therapeutic strategy in well child health nursing telephone consultations.

PubMed

Polaschek, Linda; Polaschek, Nick

2007-07-01

This paper is a report of a study to explore well child nurses' perceptions of outcomes resulting from the use of solution-focused conversations in their telephone consultations with clients. Well child nurses (health visitors) in some services provide a separate telephone consultation service for parents who need immediate advice or are unable to visit the clinic. As well as purely physical issues suggesting infant pathology, these consultations address a range of other concerns relating to parenting and child behaviour. The standard problem-solving approach used to address physical issues is less effective for various non-physical concerns, where different communication strategies may be helpful. In this qualitative, action-oriented study, a small group of well child telenurses in New Zealand was introduced to a specific communication strategy, called 'solution-focused conversations', during 2005. They applied this approach in their practice and then reflected together on their experiences in focus groups. The nurses considered that the solution-focused conversations enabled clients to: recognize the nature of the parenting issue of concern that had motivated their call; identify more effective parenting practices to address specific issues with their child; increase their confidence in their own parenting capabilities. This study suggested the value of learning a specific communication strategy for the practice of a group of well child telenurses. Solution-focused conversation is a suitable approach for the single, relatively short, interactions involved in telephone nursing. Other communication strategies could be appropriate for nurses in different clinical situations.

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.

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

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

PubMed

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. 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/

[Guidelines for wise utilization of knee imaging].

PubMed

Finestone, Aharon S; Eshed, Iris; Freedman, Yehuda; Beer, Yiftah; Bar-Sever, Zvi; Kots, Yavvgeni; Adar, Eliyahu; Mann, Gideon

2012-02-01

The knee is a complex structure afflicted with diverse pathologies. Correct management of knee complaints demands wise utilization of imaging modalities, considering their accuracy in the specific clinical situation, the patient's safety and availability and financial issues. Some of these considerations are universal, while others are local, depending on medical and insurance systems. There is controversy and unclearness regarding the best imaging modality in different clinical situations. To develop clinical guidelines for utilizing knee imaging. Leading physicians in specialties associated with knee disease and imaging were invited to participate in a panel on the guidelines. Controversies were settled in the main panel or in sub-panels. The panel agreed on the principles in choosing from the various modalities, primarily medical accuracy, followed by patient safety, availability and cost. There was agreement that the physician is responsible to choose the most appropriate diagnostic tool, consulting, when necessary, on the advantages, limitations and risks of the various imaging modalities. A comprehensive table was compiled with the importance of the different imaging modalities in various clinical situations. For the first time, Israeli guidelines on wise utilization of knee imaging are presented. They take into consideration the clinical situations and also availability and financial issues specific to Israel. These guidelines will serve physicians of several disciplines and medical insurers to improve patient management efficiently.

Neurogenetics in Child Neurology: Redefining a Discipline in the Twenty-first Century.

PubMed

Kaufmann, Walter E

2016-12-01

Increasing knowledge on genetic etiology of pediatric neurologic disorders is affecting the practice of the specialty. I reviewed here the history of pediatric neurologic disorder classification and the role of genetics in the process. I also discussed the concept of clinical neurogenetics, with its role in clinical practice, education, and research. Finally, I propose a flexible model for clinical neurogenetics in child neurology in the twenty-first century. In combination with disorder-specific clinical programs, clinical neurogenetics can become a home for complex clinical issues, repository of genetic diagnostic advances, educational resource, and research engine in child neurology.

Overview of cancer vaccines

PubMed Central

Kudrin, Alex

2012-01-01

Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines. PMID:22894970

Assessment of positive functioning in clinical psychology: theoretical and practical issues.

PubMed

Joseph, Stephen; Wood, Alex

2010-11-01

Positive psychology has led to an increasing emphasis on the promotion of positive functioning in clinical psychology research and practice, raising issues of how to assess the positive in clinical setting. Three key considerations are presented. First, existing clinical measures may already be assessing positive functioning, if positive and negative functioning exist on a single continuum (such as on bipolar dimensions from happiness to depression, and from anxiety to relaxation). Second, specific measures of positive functioning (e.g., eudemonic well-being) could be used in conjunction with existing clinical scales. Third, completely different measures would be needed depending on whether well-being is defined as emotional or medical functioning, or as humanistically orientated growth (e.g., authenticity). It is important that clinical psychologists introduce positive functioning into their research and practice in order to widen their armoury of therapeutic interventions, but in doing so researchers and practitioners need also to be aware that they are shifting the agenda of clinical psychology. As such, progress in clinical psychology moving toward the adoption of positive functioning requires reflection on epistemological foundations. Copyright © 2010 Elsevier Ltd. All rights reserved.

Clinical errors and therapist discomfort with client disclosure of troublesome pornography use: Implications for clinical practice and error reduction.

PubMed

Walters, Nathan T; Spengler, Paul M

2016-09-01

Mental health professionals are increasingly aware of the need for competence in the treatment of clients with pornography-related concerns. However, while researchers have recently sought to explore efficacious treatments for pornography-related concerns, few explorations of potential clinical judgment issues have occurred. Due to the sensitive, and at times uncomfortable, nature of client disclosures of sexual concerns within therapy, therapists are required to manage their own discomfort while retaining fidelity to treatment. The present paper explores clinician examples of judgment errors that may result from feelings of discomfort, and specifically from client use of pornography. Issues of potential bias, bias management techniques, and therapeutic implications are discussed. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

'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.

Improving data transparency in clinical trials using blockchain smart contracts.

PubMed

Nugent, Timothy; Upton, David; Cimpoesu, Mihai

2016-01-01

The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.

European Association of Endoscopic Surgeons (EAES) consensus statement on the use of robotics in general surgery.

PubMed

Szold, Amir; Bergamaschi, Roberto; Broeders, Ivo; Dankelman, Jenny; Forgione, Antonello; Langø, Thomas; Melzer, Andreas; Mintz, Yoav; Morales-Conde, Salvador; Rhodes, Michael; Satava, Richard; Tang, Chung-Ngai; Vilallonga, Ramon

2015-02-01

Following an extensive literature search and a consensus conference with subject matter experts the following conclusions can be drawn: 1. Robotic surgery is still at its infancy, and there is a great potential in sophisticated electromechanical systems to perform complex surgical tasks when these systems evolve. 2. To date, in the vast majority of clinical settings, there is little or no advantage in using robotic systems in general surgery in terms of clinical outcome. Dedicated parameters should be addressed, and high quality research should focus on quality of care instead of routine parameters, where a clear advantage is not to be expected. 3. Preliminary data demonstrates that robotic system have a clinical benefit in performing complex procedures in confined spaces, especially in those that are located in unfavorable anatomical locations. 4. There is a severe lack of high quality data on robotic surgery, and there is a great need for rigorously controlled, unbiased clinical trials. These trials should be urged to address the cost-effectiveness issues as well. 5. Specific areas of research should include complex hepatobiliary surgery, surgery for gastric and esophageal cancer, revisional surgery in bariatric and upper GI surgery, surgery for large adrenal masses, and rectal surgery. All these fields show some potential for a true benefit of using current robotic systems. 6. Robotic surgery requires a specific set of skills, and needs to be trained using a dedicated, structured training program that addresses the specific knowledge, safety issues and skills essential to perform this type of surgery safely and with good outcomes. It is the responsibility of the corresponding professional organizations, not the industry, to define the training and credentialing of robotic basic skills and specific procedures. 7. Due to the special economic environment in which robotic surgery is currently employed special care should be taken in the decision making process when deciding on the purchase, use and training of robotic systems in general surgery. 8. Professional organizations in the sub-specialties of general surgery should review these statements and issue detailed, specialty-specific guidelines on the use of specific robotic surgery procedures in addition to outlining the advanced robotic surgery training required to safely perform such procedures.

Current status of psychology and clinical psychology in India - an appraisal.

PubMed

Virudhagirinathan, Baboo Sankar; Karunanidhi, Subbiah

2014-10-01

This paper provides an overview of the social and cultural context for the emergence and development of psychology in India and also more specifically of the development of clinical psychology. It details the range of universities offering psychology programmes and the various bodies involved in supporting the development of the psychology. The paper also describes the development of clinical psychology in India and the variety of roles undertaken by clinical psychologists. Finally, it raises a number of issues facing the development of Indian psychology into the future.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY 2016 OUTPATIENT GLUCOSE MONITORING CONSENSUS STATEMENT.

PubMed

Bailey, Timothy S; Grunberger, George; Bode, Bruce W; Handelsman, Yehuda; Hirsch, Irl B; Jovanovič, Lois; Roberts, Victor Lawrence; Rodbard, David; Tamborlane, William V; Walsh, John

2016-02-01

This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

Osteoarthritis subpopulations and implications for clinical trial design

PubMed Central

2011-01-01

Treatment guidelines for osteoarthritis have stressed the need for research on clinical predictors of response to different treatments. However, identifying such clinical predictors of response is less easy than it seems, and there is not a given classification of osteoarthritis subpopulations. This review article highlights the key methodical issues when analyzing and designing clinical studies to detect important subgroups with respect to treatment effect. In addition, we discuss the main osteoarthritis subpopulations and give examples of how specific treatment effects in these subpopulations have been assessed. PMID:21470393

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.

Learning through vulnerability: a mentor-mentee experience.

PubMed

Jones, Kohar; Reis, Shmuel

2010-01-01

The following essay, drawn from the journals and work notebook of a family medicine resident and a visiting clinical mentor, chronicles their work together in an Advanced Clinical Mentoring program. This program included afternoons of direct clinical observation immediately followed by feedback sessions. In addition to addressing specific professional issues, such as time management, limiting patient encounters, agenda matching, and the One-Minute Preceptor model, the authors developed personally as they opened themselves to learning and growing as a clinician and a teacher.

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.

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

Women-specific mental disorders in DSM-V: are we failing again?

PubMed

Wittchen, Hans-Ulrich

2010-02-01

Despite a wealth of studies on differences regarding the biobehavioral and social-psychological bases of mental disorders in men and women and repeated calls for increased attention, women-specific issues have so far not been comprehensively addressed in past diagnostic classification systems of mental disorders. There is also increasing evidence that this situation will not change significantly in the upcoming revisions of ICD-11 and DSM-V. This paper explores reasons for this continued failure, highlighting three major barriers: the fragmentation of the field of women's mental health research, lack of emphasis on diagnostic classificatory issues beyond a few selected clinical conditions, and finally, the "current rules of game" used by the current DSM-V Task Forces in the revision process of DSM-V. The paper calls for concerted efforts of researchers, clinicians, and other stakeholders within a more coherent and comprehensive framework aiming at broader coverage of women-specific diagnostic classificatory issues in future diagnostic systems.

Diagnosis of food allergies: the impact of oral food challenge testing.

PubMed

Ito, Komei

2013-01-01

A diagnosis of food allergies should be made based on the observation of allergic symptoms following the intake of suspected foods and the presence of allergen-specific IgE antibodies. The oral food challenge (OFC) test is the most reliable clinical procedure for diagnosing food allergies. Specific IgE testing of allergen components as well as classical crude allergen extracts helps to make a more specific diagnosis of food allergies. The Japanese Society of Pediatric Allergy and Clinical Immunology issued the 'Japanese Pediatric Guideline for Food Allergy 2012' to provide information regarding the standardized diagnosis and management of food allergies. This review summarizes recent progress in the diagnosis of food allergies, focusing on the use of specific IgE tests and the OFC procedure in accordance with the Japanese guidelines.

Definition of a visuospatial dimension as a step forward in the diagnostic puzzle of nonverbal learning disability.

PubMed

Poletti, Michele

2017-01-01

Although clinically recognized for almost 50 years, the categorical distinction of specific learning disabilities due to an impairment of the nonverbal domain (nonverbal learning disability [NLD]) is still debated and controversial. Unsolved issues involve theoretical models, diagnostic criteria, rehabilitative interventions, and moderator factors. These issues are briefly overviewed to sustain the need for a shift toward dimensional approaches, as suggested by research domain criteria, as a step forward in the diagnostic puzzle of NLD. With this aim, a visuospatial dimension, or spectrum, is proposed, and then clinical conditions that may fit with its impaired side are systemized, while specifying in which conditions a visuospatial impairment may be considered an NLD.

Might tumor secreted cathepsin proteases leave specific molecular signals in skin, hair and nails years before a cancer becomes clinically apparent?

PubMed

Goldstein, Mark R; Mascitelli, Luca

2017-06-01

X-ray fiber diffraction analysis (FDA) of the fibrous macromolecules in hair, nails and skin has been shown to non-invasively diagnose various cancers, at sites remote from the cancer, years before the cancer becomes clinically apparent. The technology is not widely accepted because of reproducibility issues (that can be easily resolved) and lack of an explanation as to how a clinically unapparent tumor can leave molecular "signatures" at remote sites. However, there is evidence that tumor-specific cathepsins (lysosomal proteases) circulate systemically long before a cancer is clinically apparent. As such, we hypothesize that cathepsins, by virtue of their proteolytic activity, impart molecular changes in tissues remote from the primary tumor. These subtle molecular changes, which are specific for various tumors, can be readily detected by FDA of hair, nails and skin. We call for more research in the utility of FDA and tumor specific cathepsins for the early and non-invasive diagnosis of various malignancies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Should we reconsider the routine use of placebo controls in clinical research?

PubMed

Avins, Andrew L; Cherkin, Daniel C; Sherman, Karen J; Goldberg, Harley; Pressman, Alice

2012-04-27

Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

Sex-specific issues in eating disorders: a clinical and psychopathological investigation.

PubMed

Valente, Stefano; Di Girolamo, Giulia; Forlani, Martina; Biondini, Anna; Scudellari, Paolo; De Ronchi, Diana; Atti, Anna Rita

2017-12-01

To highlight the characteristics of eating disorders (ED) in males, with particular attention to sex-related clinical features and psychiatric co-morbidities. Out of 280 persons, referred to our outpatients ED clinic between January 2011 and June 2014, 267 with complete information were included in this retrospective observational study. The men/women ratio was one to five (male 16.5% vs female 83.5%) with an increasing proportion of male patients over the years. The most frequent ED in males was binge eating disorder, whereas in females anorexia nervosa and bulimia nervosa prevailed. Excessive exercising and fasting were the most common compensation behaviours in males; while self-induced vomiting and laxative-diuretic abuse were more typical in females. Among women, the most represented psychiatric co-morbidities were mood and somatoform disorders, whereas among men, anxiety and psychosis spectrum disorders were the most frequent ones. Borderline and histrionic personality disorders were prevalent in female ED, while narcissistic and antisocial personality disorders prevailed in males. ED in men is a growing phenomenon. Male ED, compared to female ED, show differences in clinical presentation, symptoms and co-morbidities. Despite the use of clinical and psychometric evaluating tools targeting female patients, sex differences do exist and additional studies are required to investigate male specific issues in ED. Level of Evidence Level V, cross-sectional descriptive study.

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.

Clinical governance in Scotland: an educational model.

PubMed Central

Lough, Murray; Kelly, Diane; Taylor, Mike; Snadden, David; Patterson, Bill; McNamara, Iain; Murray, Stuart

2002-01-01

The concepts underpinning clinical governance are similar throughout the United Kingdom but models for its implementation will differ widely. This model aims to enable practices to identify areas for further learning and development against specific outcomes. Criteria sets and standards are suggested and a governance plan is used to allow practices to prioritise their objectives. Resourcing will always be a major issue and such a model should be fully evaluated. PMID:11942453

Clinical governance in Scotland: an educational model.

PubMed

Lough, Murray; Kelly, Diane; Taylor, Mike; Snadden, David; Patterson, Bill; McNamara, Iain; Murray, Stuart

2002-04-01

The concepts underpinning clinical governance are similar throughout the United Kingdom but models for its implementation will differ widely. This model aims to enable practices to identify areas for further learning and development against specific outcomes. Criteria sets and standards are suggested and a governance plan is used to allow practices to prioritise their objectives. Resourcing will always be a major issue and such a model should be fully evaluated.

Approach to implementing a DICOM network: incorporate both economics and workflow adaptation

NASA Astrophysics Data System (ADS)

Beaver, S. Merritt; Sippel-Schmidt, Teresa M.

1995-05-01

This paper describes an approach to aide in the decision-making process for the justification and design of a digital image and information management system. It identifies key technical and clinical issues that need to be addressed by a healthcare institution during this process. Some issues identified here are very controversial and may take months or years for a department to determine solutions which meet their specific staffing, financial, and technical needs.

Use of Genetic Testing for Primary Immunodeficiency Patients.

PubMed

Heimall, Jennifer R; Hagin, David; Hajjar, Joud; Henrickson, Sarah E; Hernandez-Trujillo, Hillary S; Tan, Yuval; Kobrynski, Lisa; Paris, Kenneth; Torgerson, Troy R; Verbsky, James W; Wasserman, Richard L; Hsieh, Elena W Y; Blessing, Jack J; Chou, Janet S; Lawrence, Monica G; Marsh, Rebecca A; Rosenzweig, Sergio D; Orange, Jordan S; Abraham, Roshini S

2018-04-01

Genetic testing plays a critical role in diagnosis for many primary immunodeficiency diseases. The goals of this report are to outline some of the challenges that clinical immunologists face routinely in the use of genetic testing for patient care. In addition, we provide a review of the types of genetic testing used in the diagnosis of PID, including their strengths and limitations. We describe the strengths and limitations of different genetic testing approaches for specific clinical contexts that raise concern for specific PID disorders in light of the challenges reported by the clinical immunologist members of the CIS in a recent membership survey. Finally, we delineate the CIS's recommendations for the use of genetic testing in light of these issues.

Anticipating issues related to increasing preimplantation genetic diagnosis use: a research agenda.

PubMed

Klitzman, Robert; Appelbaum, Paul S; Chung, Wendy; Sauer, Mark

2008-01-01

Increasing use of preimplantation genetic diagnosis (PGD) poses numerous clinical, social, psychological, ethical, legal and policy dilemmas, many of which have received little attention. Patients and providers are now considering and using PGD for a widening array of genetic disorders, and patients may increasingly seek 'designer babies.' In the USA, although governmental oversight policies have been discussed, few specific guidelines exist. Hence, increasingly, patients and providers will face challenging ethical and policy questions of when and for whom to use PGD, and how it should be financed. These issues should be better clarified and addressed through collection of data concerning the current use of PGD in the USA, including factors involved in decision making about PGD use, as well as the education of the various communities that are, and should be, involved in its implementation. Improved understanding of these issues will ultimately enhance the development and implementation of future clinical guidelines and policies.

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.

Introducing clinical supervision across Western Australian public mental health services.

PubMed

Taylor, Monica; Harrison, Carole A

2010-08-01

Retention and recruitment of the mental health nursing workforce is a critical issue in Australia and more specifically in Western Australia (WA), partly due to the isolation of the state. It has been suggested that these workforce issues might be minimized through the introduction of clinical supervision within WA mental health services, where, historically, it has been misunderstood and viewed with caution by mental health nurses. This may have been partly due to a lack of understanding of clinical supervision, its models, and its many benefits, due to a paucity of information delivered into initial nurse education programs. The aim of this pilot project is to explore and evaluate the introduction of clinical supervision in WA public mental health services. A quantitative approach informed the study and included the use of an information gathering survey initially, which was followed with evaluation questionnaires. The findings show that education can increase the uptake of clinical supervision. Further, the findings illustrate the importance of linking clinicians from all professional groups via a clinical supervision web-based database.

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

CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM--2015 EXECUTIVE SUMMARY.

PubMed

Garber, Alan J; Abrahamson, Martin Julian; Barzilay, Joshua I; Blonde, Lawrence; Bloomgarden, Zachary T; Bush, Michael A; Dagogo-Jack, Samuel; Davidson, Michael B; Einhorn, Daniel; Garber, Jeffrey R; Garvey, W Timothy; Grunberger, George; Handelsman, Yehuda; Hirsch, Irl B; Jellinger, Paul S; McGill, Janet B; Mechanick, Jeffrey I; Rosenblit, Paul David; Umpierrez, Guillermo E

2015-12-01

This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON TESTING FOR AUTONOMIC AND SOMATIC NERVE DYSFUNCTION.

PubMed

Vinik, Aaron I; Camacho, Pauline M; Davidson, Jaime A; Handelsman, Yehuda; Lando, Howard M; Leddy, Anne L; Reddy, Sethu K; Cook, Richard; Spallone, Vicenza; Tesfaye, Solomon; Ziegler, Dan

2017-12-01

This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON THE ASSOCIATION OF TESTOSTERONE AND CARDIOVASCULAR RISK.

PubMed

Goodman, Neil; Guay, Andre; Dandona, Paresh; Dhindsa, Sandeep; Faiman, Charles; Cunningham, Glenn R

2015-09-01

This document represents the official position of the American Association of Clinical Endocrinologists and the American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

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).

The evolving definition of a chondrodysplasia?

PubMed

Horton, William A

2003-01-01

Most individuals who deal with chondrodysplasias would agree that this term refers collectively to a genetically and clinically heterogeneous group of disorders of skeletal development and growth. But they might not agree on what constitutes a specific chondrodysplasia. Indeed, the way in which a specific chondrodysplasia is defined has evolved substantially over the past several decades. David Rimoin, to whom this special issue is dedicated, has played a vital role in this evolution.

Issues related to development of antiepileptogenic therapies.

PubMed

Pitkänen, Asla; Nehlig, Astrid; Brooks-Kayal, Amy R; Dudek, F Edward; Friedman, Daniel; Galanopoulou, Aristea S; Jensen, Frances E; Kaminski, Rafal M; Kapur, Jaideep; Klitgaard, Henrik; Löscher, Wolfgang; Mody, Istvan; Schmidt, Dieter

2013-08-01

Several preclinical proof-of-concept studies have provided evidence for positive treatment effects on epileptogenesis. However, none of these hypothetical treatments has advanced to the clinic. The experience in other fields of neurology such as stroke, Alzheimer's disease, or amyotrophic lateral sclerosis has indicated several problems in the design of preclinical studies, which likely contribute to failures in translating the positive preclinical data to the clinic. The Working Group on "Issues related to development of antiepileptogenic therapies" of the International League Against Epilepsy (ILAE) and the American Epilepsy Society (AES) has considered the possible problems that arise when moving from proof-of-concept antiepileptogenesis (AEG) studies to preclinical AEG trials, and eventually to clinical AEG trials. This article summarizes the discussions and provides recommendations on how to design a preclinical AEG monotherapy trial in adult animals. We specifically address study design, animal and model selection, number of studies needed, issues related to administration of the treatment, outcome measures, statistics, and reporting. In addition, we give recommendations for future actions to advance the preclinical AEG testing. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

The ENB 199: an exploration of its effects on A & E nurses' practice.

PubMed

Wood, I

1998-10-01

In the UK, educational opportunities for Accident and Emergency (A & E) nurses are varied (Smith 1994) but the course most recognized as offering specialized A & E education is the English National Board (ENB) 199 course (A & E Nursing). This article describes a research study in which semi-structured interviews were used to gain a phenomenological perspective on the effects of undertaking the ENB 199 on the clinical practice of A & E nurses. The article discusses the methodology used and gives details of the interview framework adopted. Ethical issues are considered along with data collection and analysis. Findings of the study indicate that nurses who have successfully completed the ENB 199 express feelings of enhanced self-confidence in their ability to deliver high standards of care. The notion of increased confidence was also reflected in what the nurses described as their ability to question and challenge the practice of both nursing and medical colleagues. The paper also highlights findings which relate to specific clinical issues and the benefit of having time away from clinical practice in which to discuss issues important to practising A & E nurses.

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.

Treatment of specific phobias with Eye Movement Desensitization and Reprocessing (EMDR): protocol, empirical status, and conceptual issues.

PubMed

De Jongh, A; Ten Broeke, E; Renssen, M R

1999-01-01

This paper considers the current empirical status of Eye Movement Desensitization and Reprocessing (EMDR) as a treatment method for specific phobias, along with some conceptual and practical issues in relation to its use. Both uncontrolled and controlled studies on the application of EMDR with specific phobias demonstrate that EMDR can produce significant improvements within a limited number of sessions. With regard to the treatment of childhood spider phobia, EMDR has been found to be more effective than a placebo control condition, but less effective than exposure in vivo. The empirical support for EMDR with specific phobias is still meagre, therefore, one should remain cautious. However, given that there is insufficient research to validate any method for complex or trauma related phobias, that EMDR is a time-limited procedure, and that it can be used in cases for which an exposure in vivo approach is difficult to administer, the application of EMDR with specific phobias merits further clinical and research attention.

Clinical Issues in the Treatment of Chicano Male Gang Youth.

ERIC Educational Resources Information Center

Belitz, Jerald; Valdez, Diana

1994-01-01

Critical factors in the behavior of Chicano gang youth are family disintegration, cultural dissolution, abusive family relationships, and histories of interpersonal violence. Specific treatment modalities (individual, family, group) are discussed, and the importance of a multimodal approach is emphasized. Case studies highlight family dynamics and…

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies.

PubMed

Fermaglich, Lewis J; Chen, Ru; Kim, Carol Y; Chuh, Eunjung Esther; Thomas, Teena; Shetty, Daiva; Lee, Julia; Young, Johnny; Fan, Ying

2018-01-01

The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) studies received by the US Food and Drug Administration (FDA) between 2007 and 2017, to help applicants avoid common deficiencies, minimize "refuse-to-receive" (RTR) actions, "information requests," and ANDA approval delays. Multiple internal FDA databases were searched to evaluate and summarize common deficiencies identified in ANDA submissions containing clinical endpoint studies and skin I/S/A studies that required review by the Division of Clinical Review. A total of 275 ANDA submissions with filing reviews from January 2007 to June 2017 were analyzed in this report. Two hundred eighteen (79.3%) filing reviews contained one or more deficiencies. Seventy-nine (28.7%) ANDAs were issued RTR letters because of major clinical deficiencies, specifically bioequivalence and clinical deficiencies, accounting for 9% of overall identified deficiencies. Twenty-two other categories of deficiencies are summarized into 4 main categories: missing information related to the clinical studies other than data sets (38%), missing data sets (35%), formulation issues (12%), and organization/format issues (6%). The most common deficiency in the "missing information related to the clinical studies other than data sets" category was "missing clarification of information" (22%). We also noted that the Division of Filing Review has identified these same types of deficiencies since assuming responsibility of the filing assessment for ANDAs with clinical endpoint BE studies and skin I/S/A studies. In conclusion, to minimize "refuse-to-receive" actions, "information requests," and approval of ANDA delays for generic drug products, applicants should submit full clinical study reports, including all data sets for drug products recommending clinical studies.

Quantifying motivational deficits and apathy: a review of the literature.

PubMed

Weiser, Mark; Garibaldi, George

2015-08-01

Varying definitions of apathy in the published literature and a lack of a consensus regarding diagnostic criteria make the identification and quantification of apathy difficult in both clinical trials and clinical practice. The Apathy Evaluation Scale was developed specifically to assess apathy, but variations in the threshold values defined for clinically significant apathy diminish its use as a screening tool in clinical trials, although it has demonstrated sensitivity to changes in treatment in a number of studies. The Neuropsychiatric Inventory contains an Apathy subscale, which has been used to identify clinical trial populations (with a consistent threshold value) and measure changes following treatment. Few of the other assessment tools currently used in patients with neuropsychiatric disorders are specific for apathy or explore it in any depth, most have not been validated in the general population, do not have cut-off points representing clinically significant apathy, and its changes over time and in response to treatment. Further research is required to address these issues in order to facilitate the quantification of apathy and its natural history. Such research should be conducted with the aim of developing new, specific tools for use across neuropsychiatric disorders. Copyright © 2015. Published by Elsevier B.V.

Improving data transparency in clinical trials using blockchain smart contracts

PubMed Central

Nugent, Timothy; Upton, David; Cimpoesu, Mihai

2016-01-01

The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history. PMID:28357041

Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy.

PubMed

Hadi, Muhammad Abdul; José Closs, S

2016-06-01

The use of qualitative research methodology is well established for data generation within healthcare research generally and clinical pharmacy research specifically. In the past, qualitative research methodology has been criticized for lacking rigour, transparency, justification of data collection and analysis methods being used, and hence the integrity of findings. Demonstrating rigour in qualitative studies is essential so that the research findings have the "integrity" to make an impact on practice, policy or both. Unlike other healthcare disciplines, the issue of "quality" of qualitative research has not been discussed much in the clinical pharmacy discipline. The aim of this paper is to highlight the importance of rigour in qualitative research, present different philosophical standpoints on the issue of quality in qualitative research and to discuss briefly strategies to ensure rigour in qualitative research. Finally, a mini review of recent research is presented to illustrate the strategies reported by clinical pharmacy researchers to ensure rigour in their qualitative research studies.

Estimating Return on Investment in Translational Research: Methods and Protocols

PubMed Central

Trochim, William; Dilts, David M.; Kirk, Rosalind

2014-01-01

Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health and its Clinical and Translational Awards (CTSA). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This paper provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities. PMID:23925706

Estimating return on investment in translational research: methods and protocols.

PubMed

Grazier, Kyle L; Trochim, William M; Dilts, David M; Kirk, Rosalind

2013-12-01

Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health (NIH) and its Clinical and Translational Awards (CTSAs). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program, and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This article provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities.

Professional boundaries in the era of the Internet.

PubMed

Gabbard, Glen O; Kassaw, Kristin A; Perez-Garcia, Gonzalo

2011-01-01

The era of the Internet presents new dilemmas in educating psychiatrists about professional boundaries. The objective of this overview is to clarify those dilemmas and offer recommendations for dealing with them. The characteristics of social networking sites, blogs, and search engines are reviewed with a specific focus on their potential to present problems of professional boundaries for psychiatrists. The professional boundary questions that have arisen in the expanded world of online communication can be subdivided into three areas: ethical concerns, professionalism issues, and clinical dilemmas. Only the first category involves true boundary problems as normally defined. The expansion of the Internet has redefined traditional areas of privacy and anonymity in the clinical setting. Guidelines are proposed to manage the alteration of professional boundaries, as well as issues of professionalism and clinical work, that have arisen from the complexities of cyberspace. The author discusses implications for residency training.

[Issues on business of genetic testing in near future].

PubMed

Takada, Fumio

2009-06-01

Since 1990's, a business condition that company sells genetic testing services directly to consumers without through medical facility, so called "direct-to-consumers (DTC) genetic testing", has risen. They provide genetic testing for obesity, disease susceptibility or paternity, etc. There are serious problems in this kind of business. Most of the providers do not make sales with face-to-face selling, and do through internet instead. They do not provide genetic counseling by certified genetic counselor or clinical geneticist. Most DTC genetic testing services for disease susceptibility or predispositions including obesity, lack scientific validity, clinical validity and clinical utility. And also including paternity genetic testing, they all have risks of ethical legal and social issues (ELSI) in genetic discrimination and/or eugenics. The specific problem in Japan is that the healthcare section of the government still has not paid attention and not taken seriously the requirement to deploy safety net.

Enhancing predictive accuracy and reproducibility in clinical evaluation research: Commentary on the special section of the Journal of Evaluation in Clinical Practice.

PubMed

Bryant, Fred B

2016-12-01

This paper introduces a special section of the current issue of the Journal of Evaluation in Clinical Practice that includes a set of 6 empirical articles showcasing a versatile, new machine-learning statistical method, known as optimal data (or discriminant) analysis (ODA), specifically designed to produce statistical models that maximize predictive accuracy. As this set of papers clearly illustrates, ODA offers numerous important advantages over traditional statistical methods-advantages that enhance the validity and reproducibility of statistical conclusions in empirical research. This issue of the journal also includes a review of a recently published book that provides a comprehensive introduction to the logic, theory, and application of ODA in empirical research. It is argued that researchers have much to gain by using ODA to analyze their data. © 2016 John Wiley & Sons, Ltd.

How Should Remote Clinical Monitoring Be Used to Treat Alcohol Use Disorders?: Initial Findings From an Expert Round Table Discussion.

PubMed

Gordon, Alan; Jaffe, Adi; McLellan, A Thomas; Richardson, Gary; Skipper, Gregory; Sucher, Michel; Tirado, Carlos F; Urschel, Harold C

Scientific evidence combined with new health insurance coverage now enable a chronic illness management approach to the treatment of alcohol use disorders (AUDs), including regular monitoring of blood alcohol content (BAC), as a useful indicator of disease control. Recent technical advances now permit many different types of remote, real-time monitoring of BAC. However, there is no body of research to empirically guide clinicians in how to maximize the clinical potential of remote BAC monitoring.As an initial step in guiding and supporting such research, the manufacturer of one remote BAC monitoring system sponsored a group of experienced clinicians and clinical researchers to discuss 8 issues that generally affect remote, clinical BAC monitoring of "adults in outpatient AUD treatment."The expert panel unanimously agreed that remote BAC monitoring for at least 12 months during and after the outpatient treatment of AUD was a clinically viable deterrent to relapse. There was also consensus that positive test results (ie, recent alcohol use) should lead to intensified care and monitoring. However, there was no agreement on specific types of clinical intensification after a positive test. The panel agreed that sharing positive and negative test results with members of the patient support group was helpful in reinforcing abstinence, yet they noted many practical issues regarding information sharing that remain concerning. Significant differences within the panel on several important clinical issues underline the need for more clinical and implementation research to produce empirically-supported guidelines for the use of remote BAC monitoring in AUD treatment.

How Should Remote Clinical Monitoring Be Used to Treat Alcohol Use Disorders?: Initial Findings From an Expert Round Table Discussion

PubMed Central

Gordon, Alan; Jaffe, Adi; McLellan, A. Thomas; Richardson, Gary; Skipper, Gregory; Sucher, Michel; Tirado, Carlos F.; Urschel, Harold C.

2017-01-01

Scientific evidence combined with new health insurance coverage now enable a chronic illness management approach to the treatment of alcohol use disorders (AUDs), including regular monitoring of blood alcohol content (BAC), as a useful indicator of disease control. Recent technical advances now permit many different types of remote, real-time monitoring of BAC. However, there is no body of research to empirically guide clinicians in how to maximize the clinical potential of remote BAC monitoring. As an initial step in guiding and supporting such research, the manufacturer of one remote BAC monitoring system sponsored a group of experienced clinicians and clinical researchers to discuss 8 issues that generally affect remote, clinical BAC monitoring of “adults in outpatient AUD treatment.” The expert panel unanimously agreed that remote BAC monitoring for at least 12 months during and after the outpatient treatment of AUD was a clinically viable deterrent to relapse. There was also consensus that positive test results (ie, recent alcohol use) should lead to intensified care and monitoring. However, there was no agreement on specific types of clinical intensification after a positive test. The panel agreed that sharing positive and negative test results with members of the patient support group was helpful in reinforcing abstinence, yet they noted many practical issues regarding information sharing that remain concerning. Significant differences within the panel on several important clinical issues underline the need for more clinical and implementation research to produce empirically-supported guidelines for the use of remote BAC monitoring in AUD treatment. PMID:28157829

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.

Research and Clinical Center for Child Development Annual Report, 1982-1983.

ERIC Educational Resources Information Center

Miyake, Kazuo, Ed.

Most of the seven articles in this collection present research on the social development of young children. Specifically, "Issues in Socio-Emotional Development " (Kazuo Mikyake, Joseph Campos, and Jerome Kagan) and "Japanese vs. United States Comparison of Mother-Infant Interaction and Infant Development: A Review" (Shing-jen…

75 FR 69094 - Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... final recommendation documents, and participating in workgroups on specific topics or methods. A... literature and in the methods of evidence review; 2. Understanding and experience in the application of... based on their expertise in methodological issues such as medical decisionmaking, clinical epidemiology...

78 FR 29134 - HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-17

... quality, clinical operations, implementation, consumer technology, nationwide health information networks and privacy and security. Other groups will be convened to address specific issues as needed. HIT...) Direct the appropriate workgroup or other special group to develop a report for the HIT Standards...

Practical Parenting: A Jewish Perspective.

ERIC Educational Resources Information Center

Lipsitz, Gail Josephson

Based on the clinical expertise of social workers at Jewish Family Services of Central Maryland, this book presents practical advice for parents of all faiths, with each of 34 chapters exploring a specific parenting issue. The book is divided into five sections: (1) "Many Kinds of Families," dealing with only children, sibling struggles,…

Reflections on Ethics and Humanity in Pediatric Neurology: the Value of Recognizing Ethical Issues in Common Clinical Practice.

PubMed

Ronen, Gabriel M; Rosenbaum, Peter L

2017-05-01

Our goals in this reflection are to (i) identify the ethical dimensions inherent in any clinical encounter and (ii) bring to the forefront of our pediatric neurology practice the myriad of opportunities to explore and learn from these ethical questions. We highlight specifically Beauchamp and Childress's principles of biomedical ethics. We use the terms ethics in common clinical practice and an ethical lens to remind people of the ubiquity of ethical situations and the usefulness of using existing ethical principles to analyze and resolve difficult situations in clinical practice. We start with a few common situations with which many of us tend to struggle. We describe what we understand as ethics and how and why developments in technology, novel potential interventions, policies, and societal perspectives challenge us to think about and debate ethical issues. Individual patients are not a singular population; each patient has their own unique life situations, culture, goals, and expectations that need to be considered with a good dose of humanity and humility. We believe that using an ethical lens-by which we mean making an explicit effort to identify and consider these issues openly-will help us to achieve this goal in practice, education, and research.

Data-driven risk identification in phase III clinical trials using central statistical monitoring.

PubMed

Timmermans, Catherine; Venet, David; Burzykowski, Tomasz

2016-02-01

Our interest lies in quality control for clinical trials, in the context of risk-based monitoring (RBM). We specifically study the use of central statistical monitoring (CSM) to support RBM. Under an RBM paradigm, we claim that CSM has a key role to play in identifying the "risks to the most critical data elements and processes" that will drive targeted oversight. In order to support this claim, we first see how to characterize the risks that may affect clinical trials. We then discuss how CSM can be understood as a tool for providing a set of data-driven key risk indicators (KRIs), which help to organize adaptive targeted monitoring. Several case studies are provided where issues in a clinical trial have been identified thanks to targeted investigation after the identification of a risk using CSM. Using CSM to build data-driven KRIs helps to identify different kinds of issues in clinical trials. This ability is directly linked with the exhaustiveness of the CSM approach and its flexibility in the definition of the risks that are searched for when identifying the KRIs. In practice, a CSM assessment of the clinical database seems essential to ensure data quality. The atypical data patterns found in some centers and variables are seen as KRIs under a RBM approach. Targeted monitoring or data management queries can be used to confirm whether the KRIs point to an actual issue or not.

Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

PubMed Central

Russo, Ethan B.

2016-01-01

This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558

[Differential diagnosis of febrile exanthema].

PubMed

Aramă, St S; Anca, Ioana Alina; Munteanu, Daniela-Ioana; Aramă, Victoria; Hristea, Adriana; Moroti, Ruxandra; Ion, Daniela Adriana

2007-01-01

Febrile exanthema (FE) is an extremely polymorphous clinical entity, frequently seen in daily clinical practice. FE is characterized by diffuse rash and fever. FE is classified in 4 types, depending on the primary skin lesion: macular, maculopapular, vesicular, and bullous exanthema. It is of infectious and non-infectious cause. Among the infectious causes the most frequent is the viral one. FE may affect all ages, but especially children and young people. Usually, FE raises important issues of differential diagnosis, because its clinical and etiological complexity. To decide the most appropriate therapeutic and prophylactic measures for FE, it is important to know the clinical criteria and the specific diagnostic methods.

Clinical approach to Parkinson's disease: features, diagnosis, and principles of management.

PubMed

Massano, João; Bhatia, Kailash P

2012-06-01

Parkinson's disease (PD) is one of the most common neurodegenerative disorders. The condition causes a heavy burden both on those affected, as well as their families. Accurate diagnosis is critical and remains founded on clinical grounds as no specific diagnostic test is available so far. The clinical picture of PD is typical in many instances; however, features distinguishing it from other disorders should be thoroughly sought. Monogenic forms of PD also have some distinctive characteristics in many cases. This text is a roadmap to accurate diagnosis in PD, as it approaches clinical features, diagnostic methodology, and leading differential diagnoses. Therapeutic issues are also briefly discussed.

Clinical studies and anti-inflammatory mechanisms of treatments

PubMed Central

French, Jacqueline A.; Koepp, Matthias; Naegelin, Yvonne; Vigevano, Federico; Auvin, Stéphane; Rho, Jong M.; Rosenberg, Evan; Devinsky, Orrin; Olofsson, Peder S.; Dichter, Marc A.

2017-01-01

Summary In this exciting era, we are coming closer and closer to bringing an anti-inflammatory therapy to the clinic for the purpose of seizure prevention, modification, and/or suppression. At present, it is unclear what this approach might entail, and what form it will take. Irrespective of the therapy that ultimately reaches the clinic, there will be some commonalities with regard to clinical trials. A number of animal models have now been used to identify inflammation as a major underlying mechanism of both chronic seizures and the epileptogenic process. These models have demonstrated that specific anti-inflammatory treatments can be effective at both suppressing chronic seizures and interfering with the process of epileptogenesis. Some of these have already been evaluated in early phase clinical trials. It can be expected that there will soon be more clinical trials of both “conventional, broad spectrum” anti-inflammatory agents and novel new approaches to utilizing specific anti-inflammatory therapies with drugs or other therapeutic interventions. A summary of some of those approaches appears below, as well as a discussion of the issues facing clinical trials in this new domain. PMID:28675558

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

Practice pattern and professional issues of nurse practitioners in mechanical circulatory support programs in the United States: a survey report.

PubMed

Casida, Jesus M; Pastor, Jessica

2012-09-01

Few data-based reports about the role and work environment of advanced practice nurses, specifically nurse practitioners in mechanical circulatory support programs, have been published. To describe the practice pattern and professional issues confronted by nurse practitioners in the rapidly evolving and expanding mechanical circulatory support programs in the United States. A descriptive research design was employed using the data from the 2010 mechanical circulatory support nurses survey. Quantitative and qualitative data that pertained to the demographic and practice profiles as well as barriers and overall issues faced by the nurse practitioners in their clinical practice were analyzed. Nonrandom sample of 48 nurse practitioners from 95 mechanical circulatory support programs nationwide. The practice pattern of nurse practitioners in mechanical circulatory support programs is similar to the practice pattern reported for nurse practitioners in acute and critical care settings. However, only 44% and 10% of nurse practitioners in mechanical circulatory support programs are authorized to admit and transfer patients into and out of the hospital, respectively. High workload, lack of institutional support, knowledge deficit, role ambiguity, lack of professional recognition, and burnout were the common issues faced by the participants in their clinical practice. The results provide preliminary evidence on the practice pattern, restrictions, and work environment issues that may threaten the viability of an mechanical circulatory support program in which nurse practitioners play a crucial role. Implications for clinical practice, research, and policy development are discussed.

The interaction between equipoise and logistics in clinical trials: A case study.

PubMed

Warshaw, Meredith G; Carey, Vincent J; McFarland, Elizabeth J; Dawson, Liza; Abrams, Elaine; Melvin, Ann; Fairlie, Lee; Spiegel, Hans; Jay, Jonathan; Agwu, Allison L

2017-06-01

Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards. A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual. When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.

An environmental scan of weight assessment and management practices in paediatric spina bifida clinics across Canada.

PubMed

McPherson, Amy C; Leo, Jennifer; Church, Paige; Lyons, Julia; Chen, Lorry; Swift, Judy

2014-01-01

Childhood obesity is a global health concern, but children with spina bifida in particular have unique interacting risk factors for increased weight. To identify and explore current clinical practices around weight assessment and management in pediatric spina bifida clinics. An online, self-report survey of healthcare professionals (HCPs) was conducted in all pediatric spina bifida clinics across Canada (15 clinics). Summary and descriptive statistics were calculated and descriptive thematic analysis was performed on free text responses. 52 responses across all 15 clinics indicated that weight and height were assessed and recorded most of the time using a wide variety of methods, although some HCPs questioned their suitability for children with spina bifida. Weight and height information was not routinely communicated to patients and their families and HCPS identified considerable barriers to discussing weight-related information in consultations. Despite weight and height reportedly being measured regularly, HCPs expressed concern over the lack of appropriate assessment and classification tools. Communication across multi-disciplinary team members is required to ensure that children with weight-related issues do not inadvertently get overlooked. Specific skill training around weight-related issues and optimizing consultation time should be explored further for HCPs working with this population.

Establishing a binational student-run free-clinic in Tijuana, Mexico: a model for US-Mexico border states.

PubMed

Ojeda, Victoria D; Eppstein, Amy; Lozada, Remedios; Vargas-Ojeda, Adriana C; Strathdee, Steffanie A; Goodman, David; Burgos, Jose L

2014-06-01

In 2011, a bi-national student-run free clinic for the underserved, known as "Health Frontiers in Tijuana" (HFiT), was created in Tijuana, Mexico. Students and faculty from one Mexican and one US medical school staff the clinic and attend patients on Saturdays. Students from both medical schools enroll in a didactic course during the quarter/semester that they attend the free clinic. The course addresses clinical, ethical, cultural, population-specific issues and the structure, financing and delivery of medical care in Mexico. The clinic implements an electronic medical record and is developing telemedicine for consulting on complex cases. Despite challenges related to sustaining adequate funding, this program may be replicated in other border communities.

The provision of neuropsychological services in rural/regional settings: professional and ethical issues.

PubMed

Allott, Kelly; Lloyd, Susan

2009-07-01

Despite rapid growth of the discipline of clinical neuropsychology during recent times, there is limited information regarding the identification and management of professional and ethical issues associated with the practice of neuropsychology within rural settings. The aim of this article is to outline the characteristics unique to practicing neuropsychology in rural communities and to describe the potential professional and ethical dilemmas that might arise. Issues are illustrated using examples from neuropsychological practice in a rural/regional setting in Victoria, Australia. Relative to urban regions, there is an inequality in the distribution of psychologists, including neuropsychologists, in rural areas. The unique characteristics of rural and regional communities that impact on neuropsychological practice are: 1) limited resources in expertise, technology, and community services, 2) greater travel distances and costs, 3) professional isolation, and 4) beliefs about psychological services. These characteristics lower the threshold for particular ethical issues. The ethical issues that require anticipation and careful management include: 1) professional competence, 2) multiple relationships, and 3) confidentiality. Through increased awareness and management of rural-specific professional and ethical issues, rural neuropsychologists can experience their work as rewarding and enjoyable. Specific guidelines for identifying, managing, and resolving ethically and professionally challenging situations that may arise during rural practice are provided.

Integrated interdisciplinary training in the radiological sciences.

PubMed

Brenner, D J; Vazquez, M; Buonanno, M; Amundson, S A; Bigelow, A W; Garty, G; Harken, A D; Hei, T K; Marino, S A; Ponnaiya, B; Randers-Pehrson, G; Xu, Y

2014-02-01

The radiation sciences are increasingly interdisciplinary, both from the research and the clinical perspectives. Beyond clinical and research issues, there are very real issues of communication between scientists from different disciplines. It follows that there is an increasing need for interdisciplinary training courses in the radiological sciences. Training courses are common in biomedical academic and clinical environments, but are typically targeted to scientists in specific technical fields. In the era of multidisciplinary biomedical science, there is a need for highly integrated multidisciplinary training courses that are designed for, and are useful to, scientists who are from a mix of very different academic fields and backgrounds. We briefly describe our experiences running such an integrated training course for researchers in the field of biomedical radiation microbeams, and draw some conclusions about how such interdisciplinary training courses can best function. These conclusions should be applicable to many other areas of the radiological sciences. In summary, we found that it is highly beneficial to keep the scientists from the different disciplines together. In practice, this means not segregating the training course into sections specifically for biologists and sections specifically for physicists and engineers, but rather keeping the students together to attend the same lectures and hands-on studies throughout the course. This structure added value to the learning experience not only in terms of the cross fertilization of information and ideas between scientists from the different disciplines, but also in terms of reinforcing some basic concepts for scientists in their own discipline.

Sport specificity of mental disorders: the issue of sport psychiatry.

PubMed

Bär, Karl-Jürgen; Markser, Valentin Z

2013-11-01

The prevalence of psychiatric conditions among elite athletes is still under debate. More and more evidence has accumulated that high-performance athletes are not protected from mental disorders as previously thought. The authors discuss the issue of the sport specificity of selected mental diseases in elite athletes. Specific aspects of eating disorders, exercise addiction, chronic traumatic encephalopathy and mood disorders in the context of overtraining syndrome are examined. In particular, the interrelationship between life and work characteristics unique to elite athletes and the development of mental disorders are reviewed. Differences of clinical presentation and some therapeutic consequences are discussed. The authors suggest that the physical and mental strains endured by elite athletes might influence the onset and severity of their psychiatric disorder. Beside the existing research strategies dealing with the amount of exercise, its intensity and lack of recreation experienced by athletes, further research on psycho-social factors is needed to better understand the sport-specific aetiology of mental disorders in high-performance athletes.

Moving Beyond the Theoretical: Medical Students' Desire for Practical, Role-Specific Ethics Training.

PubMed

Stites, Shana D; Clapp, Justin; Gallagher, Stefanie; Fiester, Autumn

2018-05-04

Background It has been widely reported that medical trainees experience situations with profound ethical implications during their clinical rotations. To address this most U.S. medical schools include ethics curricula in their undergraduate programs. However, the content of these curricula vary substantially. Our pilot study aimed to discover, from the students' perspective, how ethics pedagogy prepares medical students for clerkship and what gaps might remain. This qualitative study organized focus groups of third- and fourth-year medical students. Participants recounted ethical concerns encountered during clerkship rotations and reflected on how their medical school ethics curriculum informed their responses to these scenarios. Transcripts of the focus group sessions were analyzed using a grounded theory approach to identify common themes that characterized the students' experiences. While students' accounts demonstrated a solid grasp of ethical theory and attunement to ethical concerns presented in the clinic, they also consistently evinced an inability to act on these issues given clerks' particular position in a complex learning hierarchy. Students felt they received too little training in the role-specific application of medical ethics as clinical trainees. We found a desire among trainees for enhanced practical ethics training in preparation for the clerkship phase of medical education. We recommend several strategies that can begin to address these findings. The use of roleplaying with standardized patients can enable students to practice engagement with ethical issues. Conventional ethics courses can focus more on action-based pedagogy and instruction in conflict management techniques. Finally, clear structures for reporting and seeking advice and support for addressing ethical issues can lessen students' apprehension to act on ethical concerns.

Clinical service lines in integrated delivery systems: an initial framework and exploration.

PubMed

Parker, V A; Charns, M P; Young, G J

2001-01-01

The increasing pressures on integrated healthcare delivery systems (IDSs) to provide coordinated and cost-effective care focuses attention on the question of how to best integrate across multiple sites of care. One increasingly common approach to this issue is the development of clinical service lines that integrate specific bundles of services across the operating units of a system. This article presents a conceptual model of service lines and reports results from a descriptive investigation of service line development among members of the Industry Advisory Board--a research consortium comprising IDSs. The experiences of these IDSs (1) provide valuable insights into the range of organizational arrangements and implementation issues that are associated with service line management in healthcare systems and (2) suggest aspects of service line management worthy of further inquiry.

Enacting relationships in marriage and family therapy: a conceptual and operational definition of an enactment.

PubMed

Davis, Sean D; Butler, Mark H

2004-07-01

Enactments are a potential common clinical process factor contributing to positive outcomes in many relational therapies. Enactments provide therapists a medium for mediating relationships through simultaneous experiential intervention and change at multiple levels of relationships--including specific relationship disagreements and problems, interaction process surrounding these issues, and underlying emotions and attachment issues confounded with those problems. We propose a model of enactments in marriage and family therapy, consisting of three components--initiation operations, intervention operations, and evaluation operations. We offer a conceptual framework to help clinicians know when and to what purpose to use this model of enactments. We provide an operational description of each component of an enactment, exemplifying them using a hypothetical clinical vignette. Directions for future research are suggested.

Development of inexpensive blood imaging systems: where are we now?

PubMed

Chu, Kaiqin; Smith, Zachary J; Wachsmann-Hogiu, Sebastian

2015-01-01

Clinical applications in the developing world, such as malaria and anemia diagnosis, demand a change in the medical paradigm of expensive care given in central locations by highly trained professionals. There has been a recent explosion in optical technologies entering the consumer market through the widespread adoption of smartphones and LEDs. This technology commoditization has enabled the development of small, portable optical imaging systems at an unprecedentedly low cost. Here, we review the state-of-the-field of the application of these systems for low-cost blood imaging with an emphasis on cellular imaging systems. In addition to some promising results addressing specific clinical issues, an overview of the technology landscape is provided. We also discuss several key issues that need to be addressed before these technologies can be commercialized.

Management of patients with amyotrophic lateral sclerosis.

PubMed

Pautex, Sophie; Janssens, Jean-Paul; Vuagnat, Hubert; Conne, Pierre; Zulian, Gilbert B

2005-10-15

Standard recommendations for the clinical management of patient with ALS have been edited in recent years. These documents emphasise the importance of patient's autonomy. To measure how these different recommendations can be applied in the context of a general hospital without a specific ALS clinic. Review of medical records of 21 patients with an ALS diagnosis treated by the University Hospitals Geneva who died from 1996-2002. Patients suffered from distressing symptoms during their last hospitalisation. Artificial nutrition was given to 5 patients. Six patients had non invasive ventilation (NIV). Written advance directives were only available in 2 cases. Discussions about theses issues were also conducted late in the evolution of the disease. Some discrepancies between our daily practice and the existing recommendations exist, particularly regarding the key issues of artificial nutrition and ventilatory support.

NCI-FDA Interagency Oncology Task Force Workshop Provides Guidance for Analytical Validation of Protein-based Multiplex Assays | Office of Cancer Clinical Proteomics Research

Cancer.gov

An NCI-FDA Interagency Oncology Task Force (IOTF) Molecular Diagnostics Workshop was held on October 30, 2008 in Cambridge, MA, to discuss requirements for analytical validation of protein-based multiplex technologies in the context of its intended use. This workshop developed through NCI's Clinical Proteomic Technologies for Cancer initiative and the FDA focused on technology-specific analytical validation processes to be addressed prior to use in clinical settings. In making this workshop unique, a case study approach was used to discuss issues related to

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

When the value of gold is zero.

PubMed

Chase, J Geoffrey; Moeller, Knut; Shaw, Geoffrey M; Schranz, Christoph; Chiew, Yeong Shiong; Desaive, Thomas

2014-06-27

This manuscript presents the concerns around the increasingly common problem of not having readily available or useful "gold standard" measurements. This issue is particularly important in critical care where many measurements used in decision making are surrogates of what we would truly wish to use. However, the question is broad, important and applicable in many other areas.In particular, a gold standard measurement often exists, but is not clinically (or ethically in some cases) feasible. The question is how does one even begin to develop new measurements or surrogates if one has no gold standard to compare with?We raise this issue concisely with a specific example from mechanical ventilation, a core bread and butter therapy in critical care that is also a leading cause of length of stay and cost of care. Our proposed solution centers around a hierarchical validation approach that we believe would ameliorate ethics issues around radiation exposure that make current gold standard measures clinically infeasible, and thus provide a pathway to create a (new) gold standard.

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.

Isolating the Effects of a Mobile Phone on the Usability and Safety of eHealth Software Applications.

PubMed

Borycki, Elizabeth M; Griffith, Janessa; Monkman, Helen; Reid-Haughian, Cheryl

2017-01-01

Mobile phones are used in conjunction with mobile eHealth software applications. These mobile software applications can be used to access, review and document clinical information. The objective of this research was to explore the relationship between mobile phones, usability and safety. Clinical simulations and semi-structured interviews were used to investigate this relationship. The findings revealed that mobile phones may lead to specific types of usability issues that may introduce some types of errors.

KEY ISSUES FOR THE ASSESSMENT OF THE ALLERGENIC POTENTIAL OF GENETICALLY MODIFIED FOODS: BREAKOUT GROUP REPORTS

EPA Science Inventory

Abstract
On the final afternoon of the Workshop, Assessment of the Allergenic Potential of Genetically Modified Foods, speakers and participants met in breakout groups to discuss specific questions in the areas of 1) Use of Human Clinical Data; 2) Animal Models to Assess Food ...

77 FR 23250 - HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-18

... quality, clinical operations, implementation, and privacy and security. Other groups are convened to address specific issues as needed, such as the Nationwide Health Information Network Power Team, the... appropriate workgroup or other special group to develop a report for the HIT Standards Committee, to the...

Methodological Issues and Practical Strategies in Research on Child Maltreatment Victims' Abilities and Experiences as Witnesses

ERIC Educational Resources Information Center

Chae, Yoojin; Goodman, Gail S.; Bederian-Gardner, Daniel; Lindsay, Adam

2011-01-01

Scientific studies of child maltreatment victims' memory abilities and court experiences have important legal, psychological, and clinical implications. However, state-of-the-art research on child witnesses is often hindered by methodological challenges. In this paper, we address specific problems investigators may encounter when attempting such…

Performance Measurement for Substance Abuse Treatment Services. Integrated Evaluation Methods. Revised.

ERIC Educational Resources Information Center

Harwood, Henrick; Bazron, Barbara; Fountain, Douglas

This paper presents state-of-the-art models addressing issues related to coordination of treatment and evaluation activities, and integration of clinical, performance, and evaluation information. Specifically, this concept paper contains a discussion of the need for and types of cost analyses for CSAT treatment evaluation and knowledge-generating…

Long-term outcomes of adults with features of VACTERL association

PubMed Central

Raam, Manu S.; Pineda-Alvarez, Daniel E.; Hadley, Donald W.; Solomon, Benjamin D.

2010-01-01

VACTERL association involves the presence of specific congenital, multi-organ malformations that tend to co-occur. Clinical and research efforts typically center on pediatric patients, and there is a scarcity of information in the literature regarding VACTERL-related issues and outcomes in adulthood. We describe here 11 adults with features of VACTERL association ascertained through our research study on the condition. In our cohort of adult patients, approximately 25% of medically significant malformations that are component features of VACTERL association, including 40% of vertebral, 50% of cardiac, and 50% of renal anomalies, were not identified during childhood. Additionally, medical sequelae of many of the primary malformations identified in infancy or early childhood persist or are first reported in adulthood. These sequelae can involve challenging medical and surgical management in adulthood. As most adults with VACTERL association are not specifically followed for VACTERL-related issues, a more uniform diagnostic work-up and a low threshold for investigation of medical sequelae of the primary disorder may enhance the quality of clinical management in these patients. PMID:20888933

Issues in contemporary and potential future molecular diagnostics for dengue.

PubMed

Sekaran, Shamala Devi; Soe, Hui Jen

2017-03-01

Dengue has been the most common arbovirus infection worldwide with 2.5 billion people living in over 100 endemic tropical and subtropical regions. Due to the high number of asymptomatic cases and the signs and symptoms being rather unspecific, dengue cases are often under-reported and might influence dengue surveillance programs. Therefore, a rapid, easy to use, inexpensive, and highly sensitive and specific diagnostic tool is essential for early and accurate diagnosis to ease the clinical management of patients as well as for the development of new interventions. Areas covered: This report discusses the contemporary dengue diagnostic tool, mainly from the aspect of molecular diagnosis where an overview of several nuclei acid amplification tests has been included. Potential molecular diagnostic tools such as biosensor and microarray are also discussed in this report. Expert commentary: Rapidness and accuracy in terms of sensitivity and specificity is imperative in dengue diagnosis for both clinical management and surveillance of dengue to ensure early treatment and corrective control measures can be carried out. In the next five years it is expected that there will be newer tests developed using not only the lateral flow techniques but more specifically biosensors and nanotechnology. These new technologies will have to be validated with the appropriate number and category of samples and to address the issue of cross-reactivity.

Fast, cheap, and out of control? Speculations and ethical concerns in the conduct of outsourced clinical trials in India.

PubMed

Kamat, Vinay R

2014-03-01

The globalization of biopharmaceutical clinical trials and their offshore outsourcing, from the West to low and middle-income countries, has come under increasing scrutiny from academic scholars, practitioners, regulatory agencies and the media. This article reports the results of a study conducted in Bangalore and Hyderabad between 2007 and 2009, to elicit the perspectives of stakeholders, concerning media representations of their work and the ethical issues that emanate from their engagement in the clinical trials enterprise. In acknowledging the inherently problematic nature of the outsourcing of clinical trials to low income countries, I argue that the practice of not prioritizing research on diseases that are most prevalent among communities, from which subjects are recruited, demands a coordinated and sustained critique. I propose that the critical discourse on the outsourcing of clinical trials should not only emphasize the perils of this practice, but also address some broader issues of equity and distributive justice that determine people's access to basic health care in low income countries. Close attention to the specific context of clinical trials in an increasingly neoliberal medical and health environment in emerging economies such as India can provide critical insights into the on-the-ground complexities and challenges of outsourced global clinical trials. Copyright © 2013 Elsevier Ltd. All rights reserved.

Incidental genetic findings in randomized clinical trials: recommendations from the Genomics and Randomized Trials Network (GARNET)

PubMed Central

2013-01-01

Recommendations and guidance on how to handle the return of genetic results to patients have offered limited insight into how to approach incidental genetic findings in the context of clinical trials. This paper provides the Genomics and Randomized Trials Network (GARNET) recommendations on incidental genetic findings in the context of clinical trials, and discusses the ethical and practical issues considered in formulating our recommendations. There are arguments in support of as well as against returning incidental genetic findings in clinical trials. For instance, reporting incidental findings in clinical trials may improve the investigator-participant relationship and the satisfaction of participation, but it may also blur the line between clinical care and research. The issues of whether and how to return incidental genetic findings, including the costs of doing so, should be considered when developing clinical trial protocols. Once decided, plans related to sharing individual results from the aim(s) of the trial, as well as incidental findings, should be discussed explicitly in the consent form. Institutional Review Boards (IRBs) and other study-specific governing bodies should be part of the decision as to if, when, and how to return incidental findings, including when plans in this regard are being reconsidered. PMID:23363732

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 ...

Raising suspicions with the Food and Drug Administration: detecting misconduct.

PubMed

Hamrell, Michael R

2010-12-01

The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.

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

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

PubMed Central

2013-01-01

Tremendous efforts have been made over the past few decades to discover novel cancer biomarkers for use in clinical practice. However, a striking discrepancy exists between the effort directed toward biomarker discovery and the number of markers that make it into clinical practice. One of the confounding issues in translating a novel discovery into clinical practice is that quite often the scientists working on biomarker discovery have limited knowledge of the analytical, diagnostic, and regulatory requirements for a clinical assay. This review provides an introduction to such considerations with the aim of generating more extensive discussion for study design, assay performance, and regulatory approval in the process of translating new proteomic biomarkers from discovery into cancer diagnostics. We first describe the analytical requirements for a robust clinical biomarker assay, including concepts of precision, trueness, specificity and analytical interference, and carryover. We next introduce the clinical considerations of diagnostic accuracy, receiver operating characteristic analysis, positive and negative predictive values, and clinical utility. We finish the review by describing components of the FDA approval process for protein-based biomarkers, including classification of biomarker assays as medical devices, analytical and clinical performance requirements, and the approval process workflow. While we recognize that the road from biomarker discovery, validation, and regulatory approval to the translation into the clinical setting could be long and difficult, the reward for patients, clinicians and scientists could be rather significant. PMID:24088261

Establishing a clinical cardiac MRI service.

PubMed

O'Regan, D P; Schmitz, S A

2006-03-01

After several years of research development cardiovascular MRI has evolved into a widely accepted clinical tool. It offers important diagnostic and prognostic information for a variety of clinical indications, which include ischaemic heart disease, cardiomyopathies, valvular dysfunction and congenital heart disorders. It is a safe non-invasive technique that employs a variety of imaging sequences optimized for temporal or spatial resolution, tissue-specific contrast, flow quantification or angiography. Cardiac MRI offers specific advantages over conventional imaging techniques for a significant number of patients. The demand for cardiac MRI studies from cardiothoracic surgeons, cardiologists and other referrers is likely to continue to rise with pressure for more widespread local service provision. Setting up a cardiac MRI service requires careful consideration regarding funding issues and how it will be integrated with existing service provision. The purchase of cardiac phased array coils, monitoring equipment and software upgrades must also be considered, as well as the training needs of those involved. The choice of appropriate imaging protocols will be guided by operator experience, clinical indication and equipment capability, and is likely to evolve as the service develops. Post-processing and offline analysis form a significant part of the time taken to report studies and an efficient method of providing quantitative reports is an important requirement. Collaboration between radiologists and cardiologists is needed to develop a successful service and multi-disciplinary meetings are key component of this. This review will explore these issues from our perspective of a new clinical cardiac MRI service operating over its first year in a teaching hospital imaging department.

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.

The ideal laboratory information system.

PubMed

Sepulveda, Jorge L; Young, Donald S

2013-08-01

Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

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

SU-E-CAMPUS-J-04: Image Guided Radiation Therapy (IGRT): Review of Technical Standards and Credentialing in Radiotherapy Clinical Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Giaddui, T; Chen, W; Yu, J

2014-06-15

Purpose: To review IGRT credentialing experience and unexpected technical issues encountered in connection with advanced radiotherapy technologies as implemented in RTOG clinical trials. To update IGRT credentialing procedures with the aim of improving the quality of the process, and to increase the proportion of IGRT credentialing compliance. To develop a living disease site-specific IGRT encyclopedia. Methods: Numerous technical issues were encountered during the IGRT credentialing process. The criteria used for credentialing review were based on: image quality; anatomy included in fused data sets and shift results. Credentialing requirements have been updated according to the AAPM task group reports for IGRTmore » to ensure that all required technical items are included in the quality review process. Implementation instructions have been updated and expanded for recent protocols. Results: Technical issues observed during the credentialing review process include, but are not limited to: poor quality images; inadequate image acquisition region; poor data quality; shifts larger than acceptable; no soft tissue surrogate. The updated IGRT credentialing process will address these issues and will also include the technical items required from AAPM: TG 104; TG 142 and TG 179 reports. An instruction manual has been developed describing a remote credentialing method for reviewers. Submission requirements are updated, including images/documents as well as facility questionnaire. The review report now includes summary of the review process and the parameters that reviewers check. We have reached consensus on the minimum IGRT technical requirement for a number of disease sites. RTOG 1311(NRG-BR002A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases) is an example, here; the protocol specified the minimum requirement for each anatomical sites (with/without fiducials). Conclusion: Technical issues are identified and reported. IGRT guidelines are updated, with the corresponding credentialing requirements. An IGRT encyclopedia describing site-specific implementation issues is currently in development.« less

Establishing A Binational Student-Run Free-Clinic In Tijuana, Mexico: A Model for U.S.-Mexico Border States

PubMed Central

Ojeda, Victoria D.; Eppstein, Amy; Lozada, Remedios; Vargas-Ojeda, Adriana C.; Strathdee, Steffanie A.; Goodman, David; Burgos, Jose L.

2013-01-01

In 2011, a bi-national student-run free clinic for the underserved, known as “Health Frontiers in Tijuana” (HFiT), was created in Tijuana, Mexico. Students and faculty from one Mexican and one U.S. medical school staff the clinic and attend patients on Saturdays. Students from both medical schools enroll in a didactic course during the quarter/semester that they attend the free clinic. The course addresses clinical, ethical, cultural, population-specific issues and the structure, financing and delivery of medical care in Mexico. The clinic implements an electronic medical record and is developing telemedicine for consulting on complex cases. Despite challenges related to sustaining adequate funding, this program may be replicated in other border communities. PMID:23371839

The diffusion of telehealth in rural American Indian communities: a retrospective survey of key stakeholders.

PubMed

Brooks, Elizabeth; Manson, Spero M; Bair, Byron; Dailey, Nancy; Shore, Jay H

2012-01-01

Mental health issues are a serious concern for many American Indian Veterans, especially for post-traumatic stress disorder and related psychiatric conditions. Yet, acquiring mental health treatment can be a challenge in Native communities where specialized services are largely unavailable. Consequently, telehealth is increasingly being suggested as a way to expand healthcare access on or near reservation lands. In this study, we wanted to understand the factors affecting the diffusion of telehealth clinics that provided mental health care to rural, American Indian Veterans. We surveyed 39 key personnel and stakeholders who were involved in the decision-making process, technological infrastructure, and implementation of three clinics. Using Roger Everett's Diffusion Theory as a framework, we gathered information about specific tasks, factors hindering progress, and personal reactions to telehealth both before and after implementation. Many participants expressed initial concerns about using telehealth; however, most became positive over time. Factors that influenced participants' viewpoint largely included patient and staff feedback and witnessing the fulfillment of a community health need. The use of outside information to support the implementation of the clinics and personal champions also showed considerable influence in the clinics' success. The findings presented here address critical gaps in our understanding of telehealth diffusion and inform research strategies regarding the cultural issues and outcomes related to telemental health services. Information contained in this report serves as a long overdue guide for developing telemental health programs and policies among American Indians, specifically, and rural populations in general.

Nurses' discourse in contraceptive prescribing: an analysis using Foucault's 'procedures of exclusion'.

PubMed

Hayter, Mark

2007-05-01

This paper is a report of an analysis of the discourse about contraceptive efficacy and side effects used by nurses when prescribing contraception. All women seeking contraception should be informed of the efficacy and potential adverse effects of the particular method they are considering. This information facilitates an informed choice. Women also require this information in order to monitor for any side effects. Paradoxically, side effects are also a key factor in reducing adherence with contraceptive regimens. However, there is no literature that explores specifically how this issue is addressed in clinical consultations, or places these practices in a theoretical context. Forty-nine consultations between nurses and women in sexual health clinics were audio-recorded during 2002. Data were subject to a discourse analysis using Foucault's 'procedures of exclusion' to explore the discursive construction of contraceptive efficacy and side effects The nurses employed specific discursive strategies when discussing contraception. When addressing efficacy, discourse centred on medico-statistical facts, but side effects were described in lay terms that minimized their severity. Nurses contextualized contraceptive side effects within potential problems that women might experience in pregnancy, and also attempted to 'normalize' contraceptive-related problems. Discourse and its deployment play a key role in practitioner-client relationships that sexual health nurses need to become more aware of how they discuss clinical issues about contraception with women. Clinical data on contraceptive side-effects are present in the literature, and it is important that sexual health nurses use this to help women make truly informed decisions.

Breath Analysis in Disease Diagnosis: Methodological Considerations and Applications

PubMed Central

Lourenço, Célia; Turner, Claire

2014-01-01

Breath analysis is a promising field with great potential for non-invasive diagnosis of a number of disease states. Analysis of the concentrations of volatile organic compounds (VOCs) in breath with an acceptable accuracy are assessed by means of using analytical techniques with high sensitivity, accuracy, precision, low response time, and low detection limit, which are desirable characteristics for the detection of VOCs in human breath. “Breath fingerprinting”, indicative of a specific clinical status, relies on the use of multivariate statistics methods with powerful in-built algorithms. The need for standardisation of sample collection and analysis is the main issue concerning breath analysis, blocking the introduction of breath tests into clinical practice. This review describes recent scientific developments in basic research and clinical applications, namely issues concerning sampling and biochemistry, highlighting the diagnostic potential of breath analysis for disease diagnosis. Several considerations that need to be taken into account in breath analysis are documented here, including the growing need for metabolomics to deal with breath profiles. PMID:24957037

Use of an Online Clinical Process Support System as an Aid to Identification and Management of Developmental and Mental Health Problems.

PubMed

Howard, Barbara J; Sturner, Raymond

2017-12-01

To describe benefits and problems with screening and addressing developmental and behavioral problems in primary care and using an online clinical process support system as a solution. Screening has been found to have various implementation barriers including time costs, accuracy, workflow and knowledge of tools. In addition, training of clinicians in dealing with identified issues is lacking. Patients disclose more to and prefer computerized screening. An online clinical process support system (CHADIS) shows promise in addressing these issues. Use of a comprehensive panel of online pre-visit screens; linked decision support to provide moment-of-care training; and post-visit activities and resources for patient-specific education, monitoring and care coordination is an efficient way to make the entire process of screening and follow up care feasible in primary care. CHADIS fulfills these requirements and provides Maintenance of Certification credit to physicians as well as added income for screening efforts.

Breath analysis in disease diagnosis: methodological considerations and applications.

PubMed

Lourenço, Célia; Turner, Claire

2014-06-20

Breath analysis is a promising field with great potential for non-invasive diagnosis of a number of disease states. Analysis of the concentrations of volatile organic compounds (VOCs) in breath with an acceptable accuracy are assessed by means of using analytical techniques with high sensitivity, accuracy, precision, low response time, and low detection limit, which are desirable characteristics for the detection of VOCs in human breath. "Breath fingerprinting", indicative of a specific clinical status, relies on the use of multivariate statistics methods with powerful in-built algorithms. The need for standardisation of sample collection and analysis is the main issue concerning breath analysis, blocking the introduction of breath tests into clinical practice. This review describes recent scientific developments in basic research and clinical applications, namely issues concerning sampling and biochemistry, highlighting the diagnostic potential of breath analysis for disease diagnosis. Several considerations that need to be taken into account in breath analysis are documented here, including the growing need for metabolomics to deal with breath profiles.

Symptoms, comorbidity, and clinical course of depression in immigrants: putting psychopathology in context.

PubMed

Saraga, Michael; Gholam-Rezaee, Mehdi; Preisig, Martin

2013-11-01

Migration is considered a depression risk factor when associated with psychosocial adversity, but its impact on depression's clinical characteristics has not been specifically studied. We compared 85 migrants to 34 controls, examining depression's severity, symptomatology, comorbidity profile and clinical course. A MINI interview modified to assess course characteristics was used to assign DSM-IV axis I diagnoses; medical files were used for Somatoform Disorders. Severity was assessed with the Montgomery-Asberg scale. Wherever possible, we adjusted comparisons for age and gender using logistic and linear regressions. Depression in migrants was characterized by higher comorbidity (mostly somatoform and anxiety disorders), higher severity, and a non-recurrent, chronic course. Our sample comes from a single center, and should be replicated in other health care facilities and other countries. Somatoform disorder diagnoses were solely based on file-content. Depression in migrants presented as a complex, chronic clinical picture. Most of our migrant patients experienced significant psychosocial adversity before and after migration: beyond cultural issues, our results suggest that psychosocial adversity impacts on the clinical expression of depression. Our study also suggests that migration associated with psychosocial adversity might play a specific etiological role, resulting in a distinct clinical picture, questioning the DSM-IV unitarian model of depression. The chronic course might indicate a resistance to standard therapeutic regimen and hints at the necessity of developing specific treatment strategies, adapted to the individual patients and their specific context. © 2013 The Authors. Published by Elsevier B.V. All rights reserved.

75 FR 52958 - Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-30

... on specific topics or methods. A diversity of perspectives is valuable to the work of the USPSTF. To... of research published in peer reviewed literature and in the methods of evidence review; 2... primary health care clinical experience may be selected based on their expertise in methodological issues...

The Mental Health of Individuals Referred for Assessment of Autism Spectrum Disorder in Adulthood: A Clinic Report

ERIC Educational Resources Information Center

Russell, Ailsa J.; Murphy, Clodagh M.; Wilson, Ellie; Gillan, Nicola; Brown, Cordelia; Robertson, Dene M.; Craig, Michael C.; Deeley, Quinton; Zinkstok, Janneke; Johnston, Kate; McAlonan, Grainne M.; Spain, Deborah; Murphy, Declan G. M.

2016-01-01

Growing awareness of autism spectrum disorders has increased the demand for diagnostic services in adulthood. High rates of mental health problems have been reported in young people and adults with autism spectrum disorder. However, sampling and methodological issues mean prevalence estimates and conclusions about specificity in psychiatric…

Clinical Issues in the Use of the "DSM-III-R" with African American Children: A Diagnostic Paradigm.

ERIC Educational Resources Information Center

Johnson, Ronn

1993-01-01

Reviews concerns related to diagnoses in delivery of mental health services, specifically, application of the principles of the Diagnostic and Statistical Manual of Mental Health Disorders (DSM-III-R) to African-American children. An alternative diagnostic model is proposed, and recommendations are made for enhancing the diagnostic process. (SLD)

Differential Effects of Social and Non-Social Reward on Response Inhibition in Children and Adolescents

ERIC Educational Resources Information Center

Kohls, Gregor; Peltzer, Judith; Herpertz-Dahlmann, Beate; Konrad, Kerstin

2009-01-01

An important issue in the field of clinical and developmental psychopathology is whether cognitive control processes, such as response inhibition, can be specifically enhanced by motivation. To determine whether non-social (i.e. monetary) and social (i.e. positive facial expressions) rewards are able to differentially improve response inhibition…

78 FR 13059 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... request to speak by April 1, 2013. Your comments should focus on issues specific to the list of topics that we have proposed to the Committee. The list of research topics to be discussed at the meeting will... clinical significance). Background information about this topic, including panel materials, is available at...

Arbitration Intervention Worker (AIW) Services: Case Management Overlay in a Juvenile Diversion Program

ERIC Educational Resources Information Center

Poythress, Norman G.; Dembo, Richard; DuDell, Gary; Wareham, Jennifer

2006-01-01

In this issue we describe a clinical trials study of the impact of adding specific case manager overlay services to "treatment as usual" services for youths in a Juvenile Arbitration Program. In this first article we describe the experimental intervention, the Arbitration Intervention Worker (AIW) service, which was provided to a randomly selected…

Tendinopathy: Evidence-Informed Physical Therapy Clinical Reasoning.

PubMed

Vicenzino, Bill

2015-11-01

Patients presenting with pain at the tendon, which is associated with physical tasks and activities that specifically load that tendon, are at the center of this special issue. The current terminology for a symptomatic tendon presentation is tendinopathy, as this does not denote an underlying pathology, but rather signals that all is not well in the tendon. Tendinopathy is a prevalent and substantial problem, as it interferes with a person's capacity to lead a physically active and healthy life, which has a considerable flow-on effect on society in general. This issue deals with the contemporary physical therapy management of tendinopathy by providing a mix of evidence review and clinical expert opinion on commonly presenting tendinopathies of the lower and upper limbs. J Orthop Sports Phys Ther 2015;45(11):816-818. doi:10.2519/jospt.2015.0110.

Current research on pycnodysostosis.

PubMed

Turan, Serap

2014-08-01

Pycnodysostosis is a rare autosomal recessive disorder caused by an inactivating mutation in cathepsin K (CTSK) and characterized by dysmorphic facial features, a short stature, acroosteolysis, osteosclerosis with increased bone fragility, and delayed closure of cranial sutures. Patients usually present with short stature or dysmorphic features the Pediatric Endocrinology or Genetics clinics, with atypical fractures to the orthopedics clinics or hematological abnormalities to the hematology clinics. However, under-diagnosis or misdiagnosis of this condition is a major issue. Pycnodysostosis is not a life threatening condition, but craniosynostosis, frequent fractures, respiratory-sleep problems, and dental problems may cause significant morbidity. Although no specific treatment for this disorder has been described, patients should be followed for complications and treated accordingly. A specific treatment for the disorder must be established in the future to prevent complications and improve quality of life for patients in the current era of advanced molecular research.

Clinical innovation for promoting family care in paediatric intensive care: demonstration, role modelling and reflective practice.

PubMed

Tomlinson, Patricia S; Thomlinson, Elizabeth; Peden-McAlpine, Cynthia; Kirschbaum, Mark

2002-04-01

To explore family caregiving problems in paediatric crisis care and methods that could be applied to move the abstraction of family care to development of specific family interventions. Family centred care has been accepted as the ideal philosophy for holistic health care of children, but methods for its implementation are not well established. In paediatric health crises, family care requires special sensitivity to family needs and a type of complex nursing care for which many practitioners are not sufficiently prepared. Developing family sensitive models of intervention and finding a strategy for transfer of this knowledge to clinical practice is an important challenge facing family nursing today. Social learning theory provides a rich background to explore these issues. Specific techniques of role modelling and reflective practice are suggested as effective approaches to teach family sensitive care in clinical settings where families are part of the care environment.

[Pursuit of economic efficiency in the hospital laboratory--full automatic re-test system of clinical chemistry, hematology, immunology and cost control system].

PubMed

Chiba, M

2000-10-01

Further business improvement is requested due to finance-based fluctuation and the influence of the revision in the medical treatment law. Therefore, new laboratories are needed. To achieving this in our hospital, economic efficiency is being pursued. The first issue is the use of space, the second issue is labor-saving. The third issue is the simplification of business procedures. There is individual quality control by the zonal verification method that we developed, as well as the quality control of the batch method using controlled substances. The four issue is cost control. By controlling the delivery and use of reagents and materials including the term of validity control, we made an effort to abolition defective stock. The fifth issue is correspondence to circulation style society. The disposal of laboratory garbage is a major issue. We controlled garbage that occurs unnecessarily. Furthermore, we are improving the demand for reagents that exceeds the specification and use reagent containers.

Ethical issues in exercise psychology.

PubMed

Pauline, Jeffrey S; Pauline, Gina A; Johnson, Scott R; Gamble, Kelly M

2006-01-01

Exercise psychology encompasses the disciplines of psychiatry, clinical and counseling psychology, health promotion, and the movement sciences. This emerging field involves diverse mental health issues, theories, and general information related to physical activity and exercise. Numerous research investigations across the past 20 years have shown both physical and psychological benefits from physical activity and exercise. Exercise psychology offers many opportunities for growth while positively influencing the mental and physical health of individuals, communities, and society. However, the exercise psychology literature has not addressed ethical issues or dilemmas faced by mental health professionals providing exercise psychology services. This initial discussion of ethical issues in exercise psychology is an important step in continuing to move the field forward. Specifically, this article will address the emergence of exercise psychology and current health behaviors and offer an overview of ethics and ethical issues, education/training and professional competency, cultural and ethnic diversity, multiple-role relationships and conflicts of interest, dependency issues, confidentiality and recording keeping, and advertisement and self-promotion.

Clinical studies and anti-inflammatory mechanisms of treatments.

PubMed

French, Jacqueline A; Koepp, Matthias; Naegelin, Yvonne; Vigevano, Federico; Auvin, Stéphane; Rho, Jong M; Rosenberg, Evan; Devinsky, Orrin; Olofsson, Peder S; Dichter, Marc A

2017-07-01

In this exciting era, we are coming closer and closer to bringing an anti-inflammatory therapy to the clinic for the purpose of seizure prevention, modification, and/or suppression. At present, it is unclear what this approach might entail, and what form it will take. Irrespective of the therapy that ultimately reaches the clinic, there will be some commonalities with regard to clinical trials. A number of animal models have now been used to identify inflammation as a major underlying mechanism of both chronic seizures and the epileptogenic process. These models have demonstrated that specific anti-inflammatory treatments can be effective at both suppressing chronic seizures and interfering with the process of epileptogenesis. Some of these have already been evaluated in early phase clinical trials. It can be expected that there will soon be more clinical trials of both "conventional, broad spectrum" anti-inflammatory agents and novel new approaches to utilizing specific anti-inflammatory therapies with drugs or other therapeutic interventions. A summary of some of those approaches appears below, as well as a discussion of the issues facing clinical trials in this new domain. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

Future Directions for Cardiovascular Disease Comparative Effectiveness Research

PubMed Central

Hlatky, Mark A; Douglas, Pamela S; Cook, Nakela L; Wells, Barbara; Benjamin, Emelia J; Dickersin, Kay; Goff, David C; Hirsch, Alan T; Hylek, Elaine M; Peterson, Eric; Roger, Véronique L; Selby, Joseph V; Udelson, James E; Lauer, Michael S

2012-01-01

Comparative effectiveness research (CER) aims to provide decision-makers the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart Lung and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address eight clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER. PMID:22796257

The Clinical Interview Schedule-Revised (CIS-R)-Malay Version, Clinical Validation.

PubMed

Subramaniam, Kavitha; Krishnaswamy, Saroja; Jemain, Abdul Aziz; Hamid, Abdul; Patel, Vikram

2006-01-01

Use of instruments or questionnaires in different cultural settings without proper validation can result in inaccurate results. Issues like reliability, validity, feasibility and acceptability should be considered in the use of an instrument. The study aims to determine the usefulness of the CIS-R Malay version in detecting common mental health problems specifically to establish the validity. The CIS-R instrument (PROQSY* format) was translated through the back translation process into Malay. Inter rater reliability was established for raters who were medical students. Cases and controls for the study were psychiatric in patients, out patient and relatives or friends accompanying the patients to the clinic or visiting the inpatients. The Malay version of CIS-R was administered to all cases and controls. All cases and controls involved in the study were rated by psychiatrists for psychiatric morbidity using the SCID as a guideline. Specificity and sensitivity of the CIS-R to the assessment by the psychiatrist were determined. The Malay version of CIS-R showed 100% sensitivity and 96.15% specificity at a cut off score of 9. The CIS-R can be a useful instrument for clinical and research use in the Malaysian population for diagnosing common mental disorders like depression and anxiety.

A review of research on salivary biomarkers for oral cancer detection

PubMed Central

2014-01-01

Using saliva for disease diagnostics and health surveillance is a promising approach as collecting saliva is relatively easy and non-invasive. Over the past two decades, using salivary biomarkers specifically for early cancer detection has attracted much research interest, especially for cancers occurring in the oral cavity and oropharynx, for which the five-year survival rate (62%) is still one of the lowest among all major human cancers. More than 90% of oral cancers are oral squamous cell carcinoma (OSCC) and the standard method for detection is through a comprehensive clinical examination by oral healthcare professionals. Despite the fact that the oral cavity is easily accessible, most OSCCs are not diagnosed until an advanced stage, which is believed to be the major reason for the low survival rate, and points to the urgent need for clinical diagnostic aids for early detection of OSCC. Thus, much research effort has been dedicated to investigating potential salivary biomarkers for OSCC, and more than 100 such biomarkers have been reported in the literature. However, some important issues and challenges have emerged that require solutions and further research in order to find reliable OSCC salivary biomarkers for clinical use. This review article provides an up-to-date list of potential OSCC salivary biomarkers reported as of the fall of 2013, and discusses those emerging issues. By raising the awareness of these issues on the part of both researchers and clinicians, it is hoped that reliable, specific and sensitive salivary biomarkers may be found soon—and not only biomarkers for early OSCC detection but also for detecting other types of cancers or even for monitoring non-cancerous disease activity. PMID:24564868

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.

Ethnic aspects of cancer trials in Asia.

PubMed

Leung, T W T

2007-01-01

New drugs which have potential in cancer therapy are emerging every day and there is an increasing demand for trial patients all over the world. Asia being the most populated continent, as well as a large market for drug sales, has its own epidemiology of disease. The Asian races also have specific genomics that might affect response to drug treatment. In addition, there are cultural issues to be considered when considering clinical trials. In conclusion, more clinical trials should be done among Asian populations for the best results of drug treatment.

[Clinical ethics consultation - an integrative model for practice and reflection].

PubMed

Reiter-Theil, Stella

2008-07-01

Broad evidence exists that health care professionals are facing ethical difficulties in patient care demanding a spectrum of useful ethics support services. Clinical ethics consultation is one of these forms of ethics support being effective in the acute setting. An authentic case is presented as an illustration. We introduce an integrative model covering the activities being characteristic for ethics consultation and going beyond "school"-specific approaches. Finally, we formulate some do's and don'ts of ethics consultation that are considered to be key issues for successful practice.

78 FR 74229 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-10

...This major final rule with comment period addresses changes to the physician fee schedule, clinical laboratory fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule with comment period also includes a discussion in the Supplementary Information regarding various programs. (See the Table of Contents for a listing of the specific issues addressed in the final rule with comment period.)

Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.

PubMed

Khin, N A; Yang, P; Hung, H M J; Maung-U, K; Chen, Y-F; Meeker-O'Connell, A; Okwesili, P; Yasuda, S U; Ball, L K; Huang, S-M; O'Neill, R T; Temple, R

2013-08-01

Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to the US Food and Drug Administration (FDA) in new drug applications. This article discusses the FDA's experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between the effectiveness and safety outcomes of studies conducted inside and outside the United States, and the FDA's approach to acceptance of these trials.

The role of external evidence in data monitoring of a clinical trial.

PubMed

Pocock, S J

1996-06-30

Data monitoring of interim results from a randomized clinical trial should take into consideration evidence from other trials. This article presents both scientific and practical issues regarding the pros and cons of formally incorporating such external evidence into the decision making process for the current trial. Guidelines on how to use other trials' data are presented, along with cautiously sceptical comments on the impracticality of using formal meta-analyses in data monitoring. The arguments are illustrated by recent examples from specific trials, and the article concludes with some general recommendations.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY PROTOCOL FOR STANDARDIZED PRODUCTION OF CLINICAL PRACTICE GUIDELINES, ALGORITHMS, AND CHECKLISTS - 2017 UPDATE.

PubMed

Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Camacho, Pauline; Correa, Ricardo; Figaro, M Kathleen; Garber, Jeffrey R; Jasim, Sina; Pantalone, Kevin M; Trence, Dace; Upala, Sikarin

2017-08-01

Clinical practice guideline (CPG), clinical practice algorithm (CPA), and clinical checklist (CC, collectively CPGAC) development is a high priority of the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE). This 2017 update in CPG development consists of (1) a paradigm change wherein first, environmental scans identify important clinical issues and needs, second, CPA construction focuses on these clinical issues and needs, and third, CPG provide CPA node/edge-specific scientific substantiation and appended CC; (2) inclusion of new technical semantic and numerical descriptors for evidence types, subjective factors, and qualifiers; and (3) incorporation of patient-centered care components such as economics and transcultural adaptations, as well as implementation, validation, and evaluation strategies. This third point highlights the dominating factors of personal finances, governmental influences, and third-party payer dictates on CPGAC implementation, which ultimately impact CPGAC development. The AACE/ACE guidelines for the CPGAC program is a successful and ongoing iterative exercise to optimize endocrine care in a changing and challenging healthcare environment. AACE = American Association of Clinical Endocrinologists ACC = American College of Cardiology ACE = American College of Endocrinology ASeRT = ACE Scientific Referencing Team BEL = best evidence level CC = clinical checklist CPA = clinical practice algorithm CPG = clinical practice guideline CPGAC = clinical practice guideline, algorithm, and checklist EBM = evidence-based medicine EHR = electronic health record EL = evidence level G4GAC = Guidelines for Guidelines, Algorithms, and Checklists GAC = guidelines, algorithms, and checklists HCP = healthcare professional(s) POEMS = patient-oriented evidence that matters PRCT = prospective randomized controlled trial.

Clinical outcomes assessment for the management of sport-related concussion.

PubMed

Valovich McLeod, Tamara C; Register-Mihalik, Johna K

2011-02-01

PATIENT SCENARIO: An adolescent female youth soccer athlete, with a previous concussion history, suffered a second concussion 4 wk ago. Her postconcussive symptoms are affecting her school performance and social and family life. CLINICAL OUTCOMES ASSESSMENT: Concussion is typically evaluated via symptoms, cognition, and balance. There is no specific patient-oriented outcomes measure for concussion. Clinicians can choose from a variety of generic and specific outcomes instruments aimed at assessing general health-related quality of life or various concussion symptoms and comorbidities such as headache, migraine, fatigue, mood disturbances, depression, anxiety, and concussion-related symptoms. CLINICAL DECISION MAKING: The data obtained from patient self-report instruments may not actively help clinicians make return-to-play decisions; however, these scales may be useful in providing information that may help the athlete return to school, work, and social activities. The instruments may also serve to identify issues that may lead to problems down the road, including depression or anxiety, or serve to further explore the nature of an athlete's symptoms. Concussion results in numerous symptoms that have the potential to linger and has been associated with depression and anxiety. The use of outcomes scales to assess health-related quality of life and the effect of other symptoms that present with a concussion may allow clinicians to better evaluate the effects of concussion on physical, cognitive, emotional, social, school, and family issues, leading to better and more complete management.

The Chinese Life-Steps Program: A Cultural Adaptation of a Cognitive-Behavioral Intervention to Enhance HIV Medication Adherence.

PubMed

Shiu, Cheng-Shi; Chen, Wei-Ti; Simoni, Jane; Fredriksen-Goldsen, Karen; Zhang, Fujie; Zhou, Hongxin

2013-05-01

China is considered to be the new frontier of the global AIDS pandemic. Although effective treatment for HIV is becoming widely available in China, adherence to treatment remains a challenge. This study aimed to adapt an intervention promoting HIV-medication adherence-favorably evaluated in the West-for Chinese HIV-positive patients. The adaptation process was theory-driven and covered several key issues of cultural adaptation. We considered the importance of interpersonal relationships and family in China and cultural notions of health. Using an evidence-based treatment protocol originally designed for Western HIV-positive patients, we developed an 11-step Chinese Life-Steps program with an additional culture-specific intervention option. We describe in detail how the cultural elements were incorporated into the intervention and put into practice at each stage. Clinical considerations are also outlined and followed by two case examples that are provided to illustrate our application of the intervention. Finally, we discuss practical and research issues and limitations emerging from our field experiments in a HIV clinic in Beijing. The intervention was tailored to address both universal and culturally specific barriers to adherence and is readily applicable to generalized clinical settings. This evidence-based intervention provides a case example of the process of adapting behavioral interventions to culturally diverse communities with limited resources.

Diagnosis and management of Silver-Russell syndrome: first international consensus statement.

PubMed

Wakeling, Emma L; Brioude, Frédéric; Lokulo-Sodipe, Oluwakemi; O'Connell, Susan M; Salem, Jennifer; Bliek, Jet; Canton, Ana P M; Chrzanowska, Krystyna H; Davies, Justin H; Dias, Renuka P; Dubern, Béatrice; Elbracht, Miriam; Giabicani, Eloise; Grimberg, Adda; Grønskov, Karen; Hokken-Koelega, Anita C S; Jorge, Alexander A; Kagami, Masayo; Linglart, Agnes; Maghnie, Mohamad; Mohnike, Klaus; Monk, David; Moore, Gudrun E; Murray, Philip G; Ogata, Tsutomu; Petit, Isabelle Oliver; Russo, Silvia; Said, Edith; Toumba, Meropi; Tümer, Zeynep; Binder, Gerhard; Eggermann, Thomas; Harbison, Madeleine D; Temple, I Karen; Mackay, Deborah J G; Netchine, Irène

2017-02-01

This Consensus Statement summarizes recommendations for clinical diagnosis, investigation and management of patients with Silver-Russell syndrome (SRS), an imprinting disorder that causes prenatal and postnatal growth retardation. Considerable overlap exists between the care of individuals born small for gestational age and those with SRS. However, many specific management issues exist and evidence from controlled trials remains limited. SRS is primarily a clinical diagnosis; however, molecular testing enables confirmation of the clinical diagnosis and defines the subtype. A 'normal' result from a molecular test does not exclude the diagnosis of SRS. The management of children with SRS requires an experienced, multidisciplinary approach. Specific issues include growth failure, severe feeding difficulties, gastrointestinal problems, hypoglycaemia, body asymmetry, scoliosis, motor and speech delay and psychosocial challenges. An early emphasis on adequate nutritional status is important, with awareness that rapid postnatal weight gain might lead to subsequent increased risk of metabolic disorders. The benefits of treating patients with SRS with growth hormone include improved body composition, motor development and appetite, reduced risk of hypoglycaemia and increased height. Clinicians should be aware of possible premature adrenarche, fairly early and rapid central puberty and insulin resistance. Treatment with gonadotropin-releasing hormone analogues can delay progression of central puberty and preserve adult height potential. Long-term follow up is essential to determine the natural history and optimal management in adulthood.

The Chinese Life-Steps Program: A Cultural Adaptation of a Cognitive-Behavioral Intervention to Enhance HIV Medication Adherence

PubMed Central

Shiu, Cheng-Shi; Chen, Wei-Ti; Simoni, Jane; Fredriksen-Goldsen, Karen; Zhang, Fujie; Zhou, Hongxin

2013-01-01

China is considered to be the new frontier of the global AIDS pandemic. Although effective treatment for HIV is becoming widely available in China, adherence to treatment remains a challenge. This study aimed to adapt an intervention promoting HIV-medication adherence—favorably evaluated in the West—for Chinese HIV-positive patients. The adaptation process was theory-driven and covered several key issues of cultural adaptation. We considered the importance of interpersonal relationships and family in China and cultural notions of health. Using an evidence-based treatment protocol originally designed for Western HIV-positive patients, we developed an 11-step Chinese Life-Steps program with an additional culture-specific intervention option. We describe in detail how the cultural elements were incorporated into the intervention and put into practice at each stage. Clinical considerations are also outlined and followed by two case examples that are provided to illustrate our application of the intervention. Finally, we discuss practical and research issues and limitations emerging from our field experiments in a HIV clinic in Beijing. The intervention was tailored to address both universal and culturally specific barriers to adherence and is readily applicable to generalized clinical settings. This evidence-based intervention provides a case example of the process of adapting behavioral interventions to culturally diverse communities with limited resources. PMID:23667305

Editorial Perspective: Pathological social withdrawal during in adolescence: a culture-specific or a global phenomenon?

PubMed

Li, Tim M H; Wong, Paul W C

2015-10-01

Impairing patterns of long-term adolescent social withdrawal and self-exclusion, including nonattendance at school or work, and minimal social contact, have been identified as a significant clinical and social problem in Japan since the late 1990s, where it is termed hikikomori. As well clinical impairment for the withdrawn youths and burden for the families, hikikomori has brought societal and health service costs in Japan. Since its first identification, similar cases have been reported in other countries. Socially withdrawn youths, unfortunately, are difficult to identify and their risks can be 'invisible' because of their withdrawn nature and the traditional perspective of what is perceived as at-risk youth. Understanding of the issue including its causes, risks, and outcomes is very limited. In this editorial perspective, we highlight how youth social withdrawal is becoming a clinical and social concern in some parts of the world and respond to the lack of research on this issue by synthesizing some of the basic research findings, and suggesting future directions for research and practice relating to this emerging youth phenomenon in middle-and-high-income countries in the hope of bringing more attention to this issue. © 2015 Association for Child and Adolescent Mental Health.

What Ethical Issues Really Arise in Practice at an Academic Medical Center? A Quantitative and Qualitative Analysis of Clinical Ethics Consultations from 2008 to 2013.

PubMed

Wasson, Katherine; Anderson, Emily; Hagstrom, Erika; McCarthy, Michael; Parsi, Kayhan; Kuczewski, Mark

2016-09-01

As the field of clinical ethics consultation sets standards and moves forward with the Quality Attestation process, questions should be raised about what ethical issues really do arise in practice. There is limited data on the type and number of ethics consultations conducted across different settings. At Loyola University Medical Center, we conducted a retrospective review of our ethics consultations from 2008 through 2013. One hundred fifty-six cases met the eligibility criteria. We analyzed demographic data on these patients and conducted a content analysis of the ethics consultation write-ups coding both the frequency of ethical issues and most significant, or key, ethical issue per case. Patients for whom ethics consultation was requested were typically male (55.8 %), white (57.1 %), between 50 and 69 years old (38.5 %), of non-Hispanic origin (85.9 %), and of Roman Catholic faith (43.6 %). Nearly half (47.4 %) were in the intensive care unit and 44.2 % died in the hospital. The most frequent broad ethical categories were decision-making (93.6 %), goals of care/treatment (80.8 %), and end-of-life (73.1 %). More specifically, capacity (57.1 %), patient's wishes/autonomy (54.5 %), and surrogate decision maker (51.3 %) were the most frequent particular ethical issues. The most common key ethical issues were withdrawing/withholding treatment (12.8 %), patient wishes/autonomy (12.2 %), and capacity (11.5 %). Our findings provide additional data to inform the training of clinical ethics consultants regarding the ethical issues that arise in practice. A wider research agenda should be formed to collect and compare data across institutions to improve education and training in our field.

A review on remote monitoring technology applied to implantable electronic cardiovascular devices.

PubMed

Costa, Paulo Dias; Rodrigues, Pedro Pereira; Reis, António Hipólito; Costa-Pereira, Altamiro

2010-12-01

Implantable electronic cardiovascular devices (IECD) include a broad spectrum of devices that have the ability to maintain rhythm, provide cardiac resynchronization therapy, and/or prevent sudden cardiac death. The incidence of bradyarrhythmias and other cardiac problems led to a broader use of IECD, which turned traditional follow-up into an extremely heavy burden for healthcare systems to support. Our aim was to assess the impact of remote monitoring on the follow-up of patients with IECD. We performed a review through PubMed using a specific query. The paper selection process included a three-step approach in which title, abstract, and cross-references were analyzed. Studies were then selected using previously defined inclusion criteria and analyzed according to the country of origin of the study, year, and journal of publication; type of study; and main issues covered. Twenty articles were included in this review. Eighty percent of the selected papers addressed clinical issues, from which 94% referred clinical events identification, clinical stability, time savings, or physician satisfaction as advantages, whereas 38% referred disadvantages that included both legal and technical issues. Forty-five percent of the papers referred patient issues, from which 89% presented advantages, focusing on patient acceptance/satisfaction, and patient time-savings. The main downsides were technical issues but patient privacy was also addressed. All the papers dealing with economic issues (20%) referred both advantages and disadvantages equally. Remote monitoring is presently a safe technology, widely accepted by patients and physicians, for its convenience, reassurance, and diagnostic potential. This review summarizes the principles of remote IECD monitoring presenting the current state-of-the-art. Patient safety and device interaction, applicability of current technology, and limitations of remote IECD monitoring are also addressed. The use of remote monitor should consider the selection of patients, the type of disease, and centers' availability to receive, interpret and respond to device alerts. Before remote IECD monitoring can be routinely used, technical, procedure, and ethical/legal issues should be addressed.

Need for gender-specific pre-analytical testing: the dark side of the moon in laboratory testing.

PubMed

Franconi, Flavia; Rosano, Giuseppe; Campesi, Ilaria

2015-01-20

Many international organisations encourage studies in a sex-gender perspective. However, research with a gender perspective presents a high degree of complexity, and the inclusion of sex-gender variable in experiments presents many methodological questions, the majority of which are still neglected. Overcoming these issues is fundamental to avoid erroneous results. Here, pre-analytical aspects of the research, such as study design, choice of utilised specimens, sample collection and processing, animal models of diseases, and the observer's role, are discussed. Artefacts in this stage of research could affect the predictive value of all analyses. Furthermore, the standardisation of research subjects according to their lifestyles and, if female, to their life phase and menses or oestrous cycle, is urgent to harmonise research worldwide. A sex-gender-specific attention to pre-analytical aspects could produce a decrease in the time for translation from the bench to bedside. Furthermore, sex-gender-specific pre-clinical pharmacological testing will enable adequate assessment of pharmacokinetic and pharmacodynamic actions of drugs and will enable, where appropriate, an adequate gender-specific clinical development plan. Therefore, sex-gender-specific pre-clinical research will increase the gender equity of care and will produce more evidence-based medicine. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Splenic marginal zone lymphoma.

PubMed

Piris, Miguel A; Onaindía, Arantza; Mollejo, Manuela

Splenic marginal zone lymphoma (SMZL) is an indolent small B-cell lymphoma involving the spleen and bone marrow characterized by a micronodular tumoral infiltration that replaces the preexisting lymphoid follicles and shows marginal zone differentiation as a distinctive finding. SMZL cases are characterized by prominent splenomegaly and bone marrow and peripheral blood infiltration. Cells in peripheral blood show a villous cytology. Bone marrow and peripheral blood characteristic features usually allow a diagnosis of SMZL to be performed. Mutational spectrum of SMZL identifies specific findings, such as 7q loss and NOTCH2 and KLF2 mutations, both genes related with marginal zone differentiation. There is a striking clinical variability in SMZL cases, dependent of the tumoral load and performance status. Specific molecular markers such as 7q loss, p53 loss/mutation, NOTCH2 and KLF2 mutations have been found to be associated with the clinical variability. Distinction from Monoclonal B-cell lymphocytosis with marginal zone phenotype is still an open issue that requires identification of precise and specific thresholds with clinical meaning. Copyright © 2016 Elsevier Ltd. All rights reserved.

Perceptions about the relative importance of patient care-related topics: a single institutional survey of its anesthesiologists, nurse anesthetists, and surgeons.

PubMed

Vetter, Thomas R; Barman, Joydip; Boudreaux, Arthur M; Jones, Keith A

2016-03-22

Persistently variable success has been experienced in locally translating even well-grounded national clinical practice guidelines, including in the perioperative setting. We have sought greater applicability and acceptance of clinical practice guidelines and protocols with our novel Perioperative Risk Optimization and Management Planning Tool (PROMPT™). This study was undertaken to survey our institutional perioperative clinicians regarding (a) their qualitative recommendations for (b) their quantitative perceptions of the relative importance of a series of clinical issues and patient medical conditions as potential topics for creating a PROMPT™. We applied a mixed methods research design that involved collecting, analyzing, and "mixing" both qualitative and quantitative methods and data in a single study to answer a research question. Survey One was qualitative in nature and asked the study participants to list as free text up to 12 patient medical conditions or clinical issues that they perceived to be high priority topics for development of a PROMPT™. Survey Two was quantitative in nature and asked the study participants to rate each of these 57 specific, pre-selected clinical issues and patient medical conditions on an 11-point Likert scale of perceived importance as a potential topic for a PROMPT™. The two electronic, online surveys were completed by participants who were recruited from the faculty in our Department of Anesthesiology and Perioperative Medicine and Department of Surgery, and the cohort of hospital-employed certified registered nurse anesthetists. A total of 57 possible topics for a PROMPT™ was created and prioritized by our stakeholders. A strong correlation (r = 0.82, 95% CI: 0.71, 0.89, P < 0.001) was observed between the quantitative clinician survey rating scores reported by the anesthesiologists/certified registered nurse anesthetists versus the surgeons. The quantitative survey displayed strong inter-rater reliability (ICC = 0.92, P < 0.001). Our qualitative clinician stakeholder survey generated a comprehensive roster of clinical issues and patient medical conditions. Our subsequent quantitative clinician stakeholder survey indicated that there is generally strong agreement among anesthesiologists/certified registered nurse anesthetists and surgeons about the relative importance of these clinical issues and patient medical conditions as potential topics for perioperative optimization and risk management.

Genetic Testing for Rare Cancer: The Wider Issues.

PubMed

Jacobs, Chris; Pichert, Gabriella

2016-01-01

Identification of a potential genetic susceptibility to cancer and confirmation of a pathogenic gene mutation raises a number of challenging issues for the patient with cancer, their relatives and the health professionals caring for them. The specific risks and management issues associated with rare cancer types have been addressed in the earlier chapters. This chapter considers the wider issues involved in genetic counselling and genetic testing for a genetic susceptibility to cancer for patients, families and health professionals. The first part of the chapter will present the issues raised by the current practice in genetic counselling and genetic testing for cancer susceptibility. The second part of the chapter will address some of the issues raised by the advances in genetic testing technology and the future opportunities provided by personalised medicine and targeted cancer therapy. Facilitating these developments requires closer integration of genomics into mainstream cancer care, challenging the existing paradigm of genetic medicine, adding additional layers of complexity to the risk assessment and management of cancer and presenting wider issues for patients, families, health professionals and clinical services.

Institutional mistrust in the organization of pharmaceutical clinical trials

PubMed Central

2010-01-01

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. PMID:18633728

Aspirin-Exacerbated Respiratory Disease: Evaluation and Management

DTIC Science & Technology

2011-01-01

will be to discuss the specific issues related to aspirin desensitization , the clinical benefits, patient selection, aspirin dosing, potential ...to the potential of “silent desensitization ” (under the blocking influence of montelukast), we recommend that all patients with history consistent...that this procedure could potentially improve existing protocols for aspi- rin challenges and desensitization . In our study, we found that patients

Developing prehospital clinical practice guidelines for resource limited settings: why re-invent the wheel?

PubMed

McCaul, Michael; de Waal, Ben; Hodkinson, Peter; Pigoga, Jennifer L; Young, Taryn; Wallis, Lee A

2018-02-05

Methods on developing new (de novo) clinical practice guidelines (CPGs) have received substantial attention. However, the volume of literature is not matched by research into alternative methods of CPG development using existing CPG documents-a specific issue for guideline development groups in low- and middle-income countries. We report on how we developed a context specific prehospital CPG using an alternative guideline development method. Difficulties experienced and lessons learnt in applying existing global guidelines' recommendations to a national context are highlighted. The project produced the first emergency care CPG for prehospital providers in Africa. It included > 270 CPGs and produced over 1000 recommendations for prehospital emergency care. We encountered various difficulties, including (1) applicability issues: few pre-hospital CPGs applicable to Africa, (2) evidence synthesis: heterogeneous levels of evidence classifications and (3) guideline quality. Learning points included (1) focusing on key CPGs and evidence mapping, (2) searching other resources for CPGs, (3) broad representation on CPG advisory boards and (4) transparency and knowledge translation. Re-inventing the wheel to produce CPGs is not always feasible. We hope this paper will encourage further projects to use existing CPGs in developing guidance to improve patient care in resource-limited settings.

Using PROMs to guide patients and practitioners through the head and neck cancer journey

PubMed Central

Rogers, Simon N; Barber, Brittany

2017-01-01

The measurement of patient-reported outcome measures (PROMs) following head and neck cancer (HNC) has the capacity to substantially enhance the care of patients and their care-givers following the diagnosis and treatment of HNC. Literature concerning PROMs has increased exponentially in the past 2 decades, producing a vast array of data upon which the multidisciplinary team can reflect. For this review, “Handle On QOL” has been used as a source of references to illustrate the points raised. PROMs are contextualized by considering the clinically-distinct key stages that cancer patients endure: diagnosis, treatment, acute toxicity, early recovery, late effects, recurrence, and palliation. The PROMs are considered in six main categories: 1) those addressing cornucopia of issues not specific to cancer; 2) those addressing issues common to all cancers; 3) questionnaires with items specific to HNC; 4) questionnaires that focus on a particular aspect of head and neck function; 5) those measuring psychological concerns, such as depression, anxiety, or self-esteem; and 6) item prompt lists. Potential benefits of PROMs in clinical practice are discussed, as are barriers to use. The way forward in integrating PROMs into routine HNC care is discussed with an emphasis on information technology. PMID:29184455

Biomimetic extracellular matrix mediated somatic stem cell differentiation: applications in dental pulp tissue regeneration

PubMed Central

Ravindran, Sriram; George, Anne

2015-01-01

Dental caries is one of the most widely prevalent infectious diseases in the world. It affects more than half of the world's population. The current treatment for necrotic dental pulp tissue arising from dental caries is root canal therapy. This treatment results in loss of tooth sensitivity and vitality making it prone for secondary infections. Over the past decade, several tissue-engineering approaches have attempted regeneration of the dental pulp tissue. Although several studies have highlighted the potential of dental stem cells, none have transitioned into a clinical setting owing to limited availability of dental stem cells and the need for growth factor delivery systems. Our strategy is to utilize the intact ECM of pulp cells to drive lineage specific differentiation of bone marrow derived mesenchymal stem cells. From a clinical perspective, pulp ECM scaffolds can be generated using cell lines and patient specific somatic stem cells can be used for regeneration. Our published results have shown the feasibility of using pulp ECM scaffolds for odontogenic differentiation of non-dental mesenchymal cells. This focused review discusses the issues surrounding dental pulp tissue regeneration and the potential of our strategy to overcome these issues. PMID:25954205

Critical role of ethics in clinical management and public health response to the West Africa Ebola epidemic.

PubMed

Folayan, Morenike O; Haire, Bridget G; Brown, Brandon

2016-01-01

The devastation caused by the Ebola virus disease (EVD) outbreak in West Africa has brought to the fore a number of important ethical debates about how best to respond to a health crisis. These debates include issues related to prevention and containment, management of the health care workforce, clinical care, and research design, all of which are situated within the overarching moral problem of severe transnational disadvantage, which has very real and specific impacts upon the ability of citizens of EVD-affected countries to respond to a disease outbreak. Ethical issues related to prevention and containment include the appropriateness and scope of quarantine and isolation within and outside affected countries. The possibility of infection in health care workers impelled consideration of whether there is an obligation to provide health services where personal protection equipment is inadequate, alongside the issue of whether the health care workforce should have special access to experimental treatment and care interventions under development. In clinical care, ethical issues include the standards of care owed to people who comply with quarantine and isolation restrictions. Ethical issues in research include appropriate study design related to experimental vaccines and treatment interventions, and the sharing of data and biospecimens between research groups. The compassionate use of experimental drugs intersects both with research ethics and clinical care. The role of developed countries also came under scrutiny, and we concluded that developed countries have an obligation to contribute to the containment of EVD infection by contributing to the strengthening of local health care systems and infrastructure in an effort to provide fair benefits to communities engaged in research, ensuring that affected countries have ready and affordable access to any therapeutic or preventative interventions developed, and supporting affected countries on their way to recovery from the impact of EVD on their social and economic lives.

Physician participation in clinical research and trials: issues and approaches

PubMed Central

Rahman, Sayeeda; Majumder, Md Anwarul Azim; Shaban, Sami F; Rahman, Nuzhat; Ahmed, Moslehuddin; Abdulrahman, Khalid Bin; D’Souza, Urban JA

2011-01-01

The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system-or organization-related as well as research-and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers. PMID:23745079

Universal Artificial Antigen Presenting Cells to Selectively Propagate T Cells Expressing Chimeric Antigen Receptor Independent of Specificity

PubMed Central

Rushworth, David; Jena, Bipulendu; Olivares, Simon; Maiti, Sourindra; Briggs, Neima; Somanchi, Srinivas; Dai, Jianliang; Lee, Dean; Cooper, Laurence J. N.

2014-01-01

T cells genetically modified to stably express immunoreceptors are being assessed for therapeutic potential in clinical trials. T cells expressing a chimeric antigen receptor (CAR) are endowed with a new specificity to target tumor-associated antigen (TAA) independent of major histocompatibility complex. Our approach to non-viral gene transfer in T cells uses ex vivo numeric expansion of CAR+ T cells on irradiated artificial antigen presenting cells (aAPC) bearing the targeted TAA. The requirement for aAPC to express a desired TAA limits the human application of CARs with multiple specificities when selective expansion through co-culture with feeder cells is sought. As an alternative to expressing individual TAAs on aAPC, we expressed one ligand that could activate CAR+ T cells for sustained proliferation independent of specificity. We expressed a CAR ligand (designated CARL) that binds the conserved IgG4 extracellular domain of CAR and demonstrated CARL+ aAPC propagate CAR+ T cells of multiple specificities. CARL avoids technical issues and costs associated with deploying clinical-grade aAPC for each TAA targeted by a given CAR. Employing CARL enables one aAPC to numerically expand all CAR+ T cells containing the IgG4 domain, and simplifies expansion, testing, and clinical translation of CAR+ T cells of any specificity. PMID:24714354

CARs: Driving T-cell specificity to enhance anti-tumor immunity

PubMed Central

Kebriaei, Partow; Kelly, Susan S.; Manuri, Pallavi; Jena, Bipulendu; Jackson, Rineka; Shpall, Elizabeth; Champlin, Richard; Cooper, Laurence J. N.

2013-01-01

Adoptive transfer of antigen-specific T cells is a compelling tool to treat cancer. To overcome issues of immune tolerance which limits the endogenous adaptive immune response to tumor-associated antigens, robust systems for the genetic modification and characterization of T cells expressing chimeric antigen receptors (CARs) to redirect specificity have been produced. Refinements with regards to persistence and trafficking of the genetically modified T cells are underway to help improve the potency of genetically modified T cells. Clinical trials utilizing this technology demonstrate feasibility, and increasingly, antitumor activity, paving the way for multi-center trials to establish the efficacy of this novel T-cell therapy. PMID:22202074

Philosophical Provocation: The Lifeblood of Clinical Ethics.

PubMed

McCullough, Laurence B

2017-02-01

The daily work of the clinical ethics teacher and clinical ethics consultant falls into the routine of classifying clinical cases by ethical type and proposing ethically justified alternatives for the professionally responsible management of a specific type of case. Settling too far into this routine creates the risk of philosophical inertia, which is not good either for the clinical ethicist or for the field of clinical ethics. The antidote to this philosophical inertia and resultant blinkered vision of clinical ethics is sustained, willing exposure to philosophical provocation. The papers in this clinical ethics issue of the Journal of Medicine and Philosophy provide just such philosophical provocation related to core topics in clinical ethics: the distinction between clinical practice and clinical research; telemedicine, or medicine at a distance; illness narratives; the concept of the placebo effect; and sex reassignment. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Bilingual Children with Primary Language Impairment: Issues, Evidence and Implications for Clinical Actions

PubMed Central

Kohnert, Kathryn

2010-01-01

A clear understanding of how to best provide clinical serves to bilingual children with suspected or confirmed primary language impairment (PLI) is predicated on understanding typical development in dual-language learners as well as the PLI profile. This article reviews general characteristics of children learning two languages, including three that challenge the diagnosis and treatment of PLI; uneven distribution of abilities in the child's two languages, cross-linguistic associations within bilingual learners, and individual variation in response to similar social circumstances. The diagnostic category of PLI (also referred to in the literature as specific language impairment or SLI) is described with attention to how language impairment, in the face of otherwise typical development, manifests in children learning two languages. Empirical evidence related to differential diagnosis of PLI in bilingual children is then reviewed and issues related to the generalization of treatment gains in dual-language learners with PLI are introduced. PMID:20371080

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.

Should psychiatrists ‘Google’ their patients?

PubMed Central

Ashby, G. Alice; O'Brien, Aileen; Bowman, Deborah; Hooper, Carwyn; Stevens, Toby; Lousada, Esther

2015-01-01

Since its beginnings in the 1980s the internet has come to shape our everyday lives, but doctors still seem rather afraid of it. This anxiety may be explained by the fact that researchers and regulatory bodies focus less on the way that the internet can be used to enhance clinical work and more on the potential and perceived risks that this technology poses in terms of boundary violations and accidental breaches of confidentiality. Some aspects of the internet's impact on medicine have been better researched than others, for example, whether email communication, social media and teleconferencing psychotherapy could be used to improve the delivery of care. However, few authors have considered the specific issue of searching online for information about patients and much of the guidance published by regulatory organisations eludes this issue. In this article we provide clinical examples where the question ‘should I Google the patient?’ may arise and present questions for future research. PMID:26755985

Tangible resources for preparing patients for antiviral therapy for chronic hepatitis C.

PubMed

Bonner, Jason E; Barritt, A Sidney; Fried, Michael W; Evon, Donna M

2012-06-01

Chronic hepatitis C (HCV) infected patients with coexisting mental health and/or substance abuse issues face significant barriers to treatment and are often deferred. This paper sought to highlight critical pre-treatment strategies and provide tangible resources for HCV clinicians to facilitate preparation and successful treatment of these patients. Guided by the clinical experience of our liver center, a large, tertiary academic medical center, and informed by the extant literature, we summarize pre-treatment strategies and specific resources and recommendations for HCV providers. Four key pre-treatment strategies include: 1) screening for mental health/substance abuse issues using brief, reliable and validated instruments; 2) locating and establishing collaborative care with mental health and substance abuse specialists; 3) using a motivational interviewing communication style; and 4) addressing adherence-related issues. HCV clinicians are in a unique position to prepare patients with coexisting mental health and/or substance abuse issues for antiviral therapy.

Evaluating a health care provider delivered intervention to reduce intimate partner violence and mitigate associated health risks: study protocol for a randomized controlled trial in Mexico City.

PubMed

Falb, Kathryn L; Diaz-Olavarrieta, Claudia; Campos, Paola A; Valades, Jimena; Cardenas, Roosebelinda; Carino, Giselle; Gupta, Jhumka

2014-07-30

Intimate partner violence (IPV) victimization is a prevalent issue among women residing in Mexico City. Comprehensive and integrated health care provider (HCP) delivered programs in clinic-settings are needed, yet few have been evaluated in Latin America, including Mexico. In addition, there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics. The current randomized controlled trial seeks to increase midlevel HCPs' capacity, specifically nurses, who are often the first point of contact in this setting, to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation. Specific outcomes include changes in past-year IPV (physical and/or sexual), reproductive coercion, safety planning, use of community resources, and quality of life. Forty-two public health clinics in Mexico City were randomized to treatment or control clinics. Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV, providing supportive referrals, and assessing for health and safety risks. Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women. Women were screened for eligibility (currently experiencing abuse in a heterosexual relationship, 18-44 years of age, non-pregnant or in first trimester) by research assistants in private areas of waiting rooms in health clinics. Consenting women completed a baseline survey and received the study protocol for that clinic. In treatment clinics, women received the nurse delivered session at baseline and received a follow-up counseling session after three months. Surveys are conducted at baseline, three months, and fifteen months from baseline. This study will provide important insight into whether a nurse-delivered program can assist women currently experiencing abuse in a Latin American context. Findings can be used to inform IPV programs and policies in Mexico City's public health clinics. NCT01661504.

Regional variation in identified cancer care needs of early-career oncologists in China, India, and Pakistan.

PubMed

Lyerly, H Kim; Fawzy, Maria R; Aziz, Zeba; Nair, Reena; Pramesh, C S; Parmar, Vani; Parikh, Purvish M; Jamal, Rozmin; Irumnaz, Azizunissa; Ren, Jun; Stockler, Martin R; Abernethy, Amy P

2015-05-01

Cancer incidence and mortality is increasing in the developing world. Inequities between low-, middle-, and high-income countries affect disease burden and the infrastructure needs in response to cancer. We surveyed early-career oncologists attending workshops in clinical research in three countries with emerging economies about their perception of the evolving cancer burden. A cross-sectional survey questionnaire was distributed at clinical trial concept development workshops held in Beijing, Lahore, Karachi, and Mumbai at major hospitals to acquire information regarding home-country health conditions and needs. A total of 100 respondents participated in the workshops held at major hospitals in the region (India = 29, China = 25, Pakistan = 42, and other = 4). Expected consensus on many issues (e.g., emergence of cancer as a significant health issue) was balanced with significant variation in priorities, opportunities, and challenges. Chinese respondents prioritized improvements in cancer-specific care and palliative care, Indian respondents favored improved cancer detection and advancing research in cancer care, and Pakistani respondents prioritized awareness of cancer and improvements in disease detection and cancer care research. For all, the most frequently cited opportunity was help in improving professional cancer education and training. Predominantly early-career oncologists attending clinical research workshops (in China, India, and Pakistan) identified needs for increasing clinical cancer research, professional education, and public awareness of cancer. Decision makers supporting efforts to reduce the burden of cancer worldwide will need to factor the specific needs and aspirations of health care providers in their country in prioritizing health policies and budgets. ©AlphaMed Press.

Methodologic issues in assessing the quality of life of cancer patients.

PubMed

Aaronson, N K

1991-02-01

Although quality of life assessments have been employed successfully in descriptive and evaluative studies in oncology, their use in cancer clinical trials has, to date, been limited. A range of issues have impeded the conduct of clinical trial-based quality of life investigations. These include: the absence of theoretical models to guide the development of quality of life measures; over-reliance on ad hoc approaches to quality of life assessment; and insufficient attention to the practical constraints operating in clinical research settings. Of primary importance is the need to develop multidimensional quality of life instruments that are brief and psychometrically robust. It is suggested that future work on instrument development focus on refining currently available generic or cancer-specific measures, and on developing new diagnostic-specific questionnaire modules. This psychometric work should be guided by appropriate theoretical models of the relationship among health-related quality of life domains. Although it is widely accepted that the patient represents the most appropriate source of quality of life data, it is suggested that efforts also be directed toward improving the validity and reliability of physician-generated assessments of patients' performance status and of treatment toxicities, and toward determining the feasibility of employing family members as proxy raters of the psychologic and social health status of patients who are unwilling or unable to provide such information. Additional attention should be paid to the many logistical problems that arise in clinical trial-based quality of life investigations. In particular, research designs and data collection procedures should be selected that minimize patient, medical staff, and institutional burden.

Ethics in oncology: consulting for the investment industry.

PubMed

Berlin, Jordan; Bruinooge, Suanna S; Tannock, Ian F

2007-02-01

As Ethics Committee Chair, I am pleased to introduce the first in an ongoing series of ethics vignettes. These columns, which are based on true-to-life situations that arise in oncology research and practice, are intended to identify and explore important ethical issues and provide commentary that is specific to oncology. Please look for them periodically in both the Journal of Clinical Oncology and the Journal of Oncology Practice. The idea for publishing vignettes evolved through the joint efforts of the Ethics Committee and the Board of Directors. Rather than adopt a single set of ethical principles that applies vaguely to any situation and well to none, the Committee and the Board preferred to tackle ethical dilemmas individually, specifically, and directly. Because the Ethics Committee thought the ethical and legal implications of physician interactions with the investment industry were so important and timely, it chose to address this topic in both a position article, which was previously published in the January 20, 2007, issue of the Journal of Clinical Oncology (J Clin Oncol 25:338-340, 2007) and in its first vignette column. The Ethics Committee hopes this column will be the first of several that ASCO members will find helpful as they grapple with the many ethical issues that arise in daily practice in the field of oncology. Because these columns are intended to address the concerns of ASCO members, the Committee welcomes suggestions for future topics at vignettes@asco.org. Martin D. Abeloff, MD, Chair, Ethics Committee.

Intraoperative Clinical Decision Support for Anesthesia: A Narrative Review of Available Systems.

PubMed

Nair, Bala G; Gabel, Eilon; Hofer, Ira; Schwid, Howard A; Cannesson, Maxime

2017-02-01

With increasing adoption of anesthesia information management systems (AIMS), there is growing interest in utilizing AIMS data for intraoperative clinical decision support (CDS). CDS for anesthesia has the potential for improving quality of care, patient safety, billing, and compliance. Intraoperative CDS can range from passive and post hoc systems to active real-time systems that can detect ongoing clinical issues and deviations from best practice care. Real-time CDS holds the most promise because real-time alerts and guidance can drive provider behavior toward evidence-based standardized care during the ongoing case. In this review, we describe the different types of intraoperative CDS systems with specific emphasis on real-time systems. The technical considerations in developing and implementing real-time CDS are systematically covered. This includes the functional modules of a CDS system, development and execution of decision rules, and modalities to alert anesthesia providers concerning clinical issues. We also describe the regulatory aspects that affect development, implementation, and use of intraoperative CDS. Methods and measures to assess the effectiveness of intraoperative CDS are discussed. Last, we outline areas of future development of intraoperative CDS, particularly the possibility of providing predictive and prescriptive decision support.

Necrotizing fasciitis: case series and review of the literature on clinical and medico-legal diagnostic challenges.

PubMed

Fais, Paolo; Viero, Alessia; Viel, Guido; Giordano, Renzo; Raniero, Dario; Kusstatscher, Stefano; Giraudo, Chiara; Cecchetto, Giovanni; Montisci, Massimo

2018-04-07

Necrotizing fasciitis (NF) is a life-threatening infection of soft tissues spreading along the fasciae to the surrounding musculature, subcutaneous fat and overlying skin areas that can rapidly lead to septic shock and death. Due to the pandemic increase of medical malpractice lawsuits, above all in Western countries, the forensic pathologist is frequently asked to investigate post-mortem cases of NF in order to determine the cause of death and to identify any related negligence and/or medical error. Herein, we review the medical literature dealing with cases of NF in a post-mortem setting, present a case series of seven NF fatalities and discuss the main ante-mortem and post-mortem diagnostic challenges of both clinical and forensic interests. In particular, we address the following issues: (1) origin of soft tissue infections, (2) micro-organisms involved, (3) time of progression of the infection to NF, (4) clinical and histological staging of NF and (5) pros and cons of clinical and laboratory scores, specific forensic issues related to the reconstruction of the ideal medical conduct and the evaluation of the causal value/link of any eventual medical error.

Opportunities at the Intersection of Bioinformatics and Health Informatics

PubMed Central

Miller, Perry L.

2000-01-01

This paper provides a “viewpoint discussion” based on a presentation made to the 2000 Symposium of the American College of Medical Informatics. It discusses potential opportunities for researchers in health informatics to become involved in the rapidly growing field of bioinformatics, using the activities of the Yale Center for Medical Informatics as a case study. One set of opportunities occurs where bioinformatics research itself intersects with the clinical world. Examples include the correlations between individual genetic variation with clinical risk factors, disease presentation, and differential response to treatment; and the implications of including genetic test results in the patient record, which raises clinical decision support issues as well as legal and ethical issues. A second set of opportunities occurs where bioinformatics research can benefit from the technologic expertise and approaches that informaticians have used extensively in the clinical arena. Examples include database organization and knowledge representation, data mining, and modeling and simulation. Microarray technology is discussed as a specific potential area for collaboration. Related questions concern how best to establish collaborations with bioscientists so that the interests and needs of both sets of researchers can be met in a synergistic fashion, and the most appropriate home for bioinformatics in an academic medical center. PMID:10984461

Faith-to-faith at the bedside: theological and ethical issues in ecumenical clinical chaplaincy.

PubMed

Mellon, Brad F

2003-04-01

Chaplains who serve in a clinical context often minister to patients representing a wide variety of faiths. In order to offer the best pastoral care possible, the chaplain should first possess a set of personal theological convictions as a foundation for ministry. Second, he or she needs to be sensitive to the beliefs and practices of the patients. Third, it is vital to develop a relationship of acceptance and trust not only with patients under their care, but also with family members and caregivers as well. At times, situations will arise that are purely religious or theological. In a clinical setting, however, the questions and problems that arise more often are both theological and ethical. It is beneficial for the chaplain to be involved in an ethics committee, where the specifics of each case can be discussed, and staff can offer counsel to patients and their families. This study examines issues that chaplains face at the bedside, such as terminal care, life-prolonging treatments, dementia, persistent vegetative state, and euthanasia-assisted suicide. We will discover that those who are involved in clinical pastoral ministry will be called upon to be a comforter, mediator, educator, ethicist, and counselor.

Exploring barriers and facilitators to participation of male-to-female transgender persons in preventive HIV vaccine clinical trials.

PubMed

Andrasik, Michele Peake; Yoon, Ro; Mooney, Jessica; Broder, Gail; Bolton, Marcus; Votto, Teress; Davis-Vogel, Annet

2014-06-01

Observed seroincidence and prevalence rates in male-to-female (MTF) transgender individuals highlight the need for effective targeted HIV prevention strategies for this community. In order to develop an effective vaccine that can be used by transgender women, researchers must understand and address existing structural issues that present barriers to this group's participation in HIV vaccine clinical trials. Overcoming barriers to participation is important for ensuring HIV vaccine acceptability and efficacy for the MTF transgender community. To explore barriers and facilitators to MTF transgender participation in preventive HIV vaccine clinical trials, the HIV Vaccine Trials Network conducted focus groups among transgender women in four urban areas (Atlanta, Boston, Philadelphia, and San Francisco). Barriers and facilitators to engagement of transgender women in preventive HIV vaccine clinical trials led to the following recommendations: (a) transgender cultural competency training, (b) creating trans-friendly environments, (c) true partnerships with local trans-friendly organizations and health care providers, (d) protocols that focus on transgender specific issues, and (e) data collection and tracking of transgender individuals. These results have implications for the conduct of HIV vaccine trials, as well as engagement of transgender women in research programs in general.

The clinical, operational, and financial worlds of neonatal palliative care: A focused ethnography.

PubMed

Williams-Reade, Jackie; Lamson, Angela L; Knight, Sharon M; White, Mark B; Ballard, Sharon M; Desai, Priti P

2015-04-01

Due to multiple issues, integrated interdisciplinary palliative care teams in a neonatal intensive care unit (NICU) may be difficult to access, sometimes fail to be implemented, or provide inconsistent or poorly coordinated care. When implementing an effective institution-specific neonatal palliative care program, it is critical to include stakeholders from the clinical, operational, and financial worlds of healthcare. In this study, researchers sought to gain a multidisciplinary perspective into issues that may impact the implementation of a formal neonatal palliative care program at a tertiary regional academic medical center. In this focused ethnography, the primary researcher conducted semistructured interviews that explored the perspectives of healthcare administrators, finance officers, and clinicians about neonatal palliative care. The perspectives of 39 study participants informed the identification of institutional, financial, and clinical issues that impact the implementation of neonatal palliative care services at the medical center and the planning process for a formal palliative care program on behalf of neonates and their families. Healthcare professionals described experiences that influenced their views on neonatal palliative care. Key themes included: (a) uniqueness of neonatal palliative care, (b) communication and conflict among providers, (c) policy and protocol discrepancies, and (d) lack of administrative support. The present study highlighted several areas that are challenging in the provision of neonatal palliative care. Our findings underscored the importance of recognizing and procuring resources needed simultaneously from the clinical, operational, and financial worlds in order to implement and sustain a successful neonatal palliative care program.

TIL 2.0: More effective and predictive T-cell products by enrichment for defined antigen specificities.

PubMed

Schober, Kilian; Busch, Dirk H

2016-06-01

Adoptive transfer of in vitro-expanded T cells derived from tumor-infiltrating lymphocytes (TILs) in melanoma patients started the era of tumor immunotherapy three decades ago. The approach has demonstrated remarkable clinical responses in several studies since. Reinfusion of TIL-derived T cells represents a highly personalized form of immunotherapy, taking into account the enormous interindividual tumor heterogeneity. However, despite its successes, TIL therapy does not lead to objective clinical responses in all cases. It is thus crucial to find out which tumor antigens are particularly valuable targets and to develop strategies to enhance the reactivity of T-cell products toward them. In this issue of the European Journal of Immunology, Kelderman et al. [Eur. J. Immunol. 2016. 46: 1351-1360] present a platform for the generation of antigen-specific TIL therapy. Combining recently developed technologies for clinical identification and enrichment of antigen-specific CD8(+) T cells, such as MHC Streptamers and UV-mediated peptide exchange, the authors could enrich T-cell populations with defined antigen specificities from melanoma-derived TILs. This T-cell product showed higher reactivity against autologous tumor cell lines than bulk TIL-derived T cells. The novel platform might enable the generation of more effective and predictable TIL-derived T-cell products for future clinical applications. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Machine Learning and Decision Support in Critical Care

PubMed Central

Johnson, Alistair E. W.; Ghassemi, Mohammad M.; Nemati, Shamim; Niehaus, Katherine E.; Clifton, David A.; Clifford, Gari D.

2016-01-01

Clinical data management systems typically provide caregiver teams with useful information, derived from large, sometimes highly heterogeneous, data sources that are often changing dynamically. Over the last decade there has been a significant surge in interest in using these data sources, from simply re-using the standard clinical databases for event prediction or decision support, to including dynamic and patient-specific information into clinical monitoring and prediction problems. However, in most cases, commercial clinical databases have been designed to document clinical activity for reporting, liability and billing reasons, rather than for developing new algorithms. With increasing excitement surrounding “secondary use of medical records” and “Big Data” analytics, it is important to understand the limitations of current databases and what needs to change in order to enter an era of “precision medicine.” This review article covers many of the issues involved in the collection and preprocessing of critical care data. The three challenges in critical care are considered: compartmentalization, corruption, and complexity. A range of applications addressing these issues are covered, including the modernization of static acuity scoring; on-line patient tracking; personalized prediction and risk assessment; artifact detection; state estimation; and incorporation of multimodal data sources such as genomic and free text data. PMID:27765959

Measurement Issues: Screening and diagnostic instruments for autism spectrum disorders – lessons from research and practice

PubMed Central

Charman, Tony; Gotham, Katherine

2012-01-01

Background and Scope Significant progress has been made over the past two decades in the development of screening and diagnostic instruments for autism spectrum disorders (ASD). This article reviews this progress, including recent innovations, focussing on those instruments for which the strongest research data on validity exists, and then turns to addressing issues arising from their use in clinical settings. Findings Research studies have evaluated the ability of screens to prospectively identify cases of ASD in population-based and clinically-referred samples, as well as the accuracy of diagnostic instruments to map onto ‘gold standard’ clinical best estimate diagnosis. However, extension of the findings to clinical services must be done with caution, with a full understanding that instrument properties are sample-specific. Furthermore, we are limited by the lack of a true test for ASD, which remains a behaviourally-defined disorder. In addition screening and diagnostic instruments help clinicians least in the cases where they are most in want of direction, since their accuracy will always be lower for marginal cases. Conclusion Instruments help clinicians to collect detailed, structured information and increase accuracy and reliability of referral for in-depth assessment and recommendations for support, but further research is needed to refine their effective use in clinical settings. PMID:23539140

Issues in the design of multisite clinical trials of psychotherapy: VA Cooperative Study No. 494 as an example.

PubMed

Schnurr, Paula P; Friedman, Matthew J; Engel, Charles C; Foa, Edna B; Shea, M Tracie; Resick, Patricia M; James, Kenneth E; Chow, Bruce K

2005-12-01

This article describes issues in the design of an ongoing multisite randomized clinical trial of psychotherapy for treating posttraumatic stress disorder (PTSD) in female veterans and active duty personnel. Research aimed at testing treatments for PTSD in women who have served in the military is especially important due to the high prevalence of PTSD in this population. VA Cooperative Study 494 was designed to enroll 384 participants across 12 sites. Participants are randomly assigned to receive 10 weekly sessions of individual psychotherapy: Prolonged Exposure, a specific cognitive-behavioral therapy protocol for PTSD, or present-centered therapy, a comparison treatment that addresses current interpersonal problems but avoids a trauma focus. PTSD is the primary outcome. Additional outcomes are comorbid problems such as depression and anxiety; psychosocial function and quality of life; physical health status; satisfaction with treatment; and service utilization. Follow-up assessments are conducted at the end of treatment and then 3 and 6 months after treatment. Both treatments are delivered according to a manual. Videotapes of therapy sessions are viewed by experts who provide feedback to therapists throughout the trial to ensure adherence to the treatment manual. Discussion includes issues encountered in multisite psychotherapy trials along with the rationale for our decisions about how we addressed these issues in CSP #494.

Viable Options for Fertility Preservation in Breast Cancer Patients: A Focus on Latin America.

PubMed

Lambertini, Matteo; Goldrat, Oranite; Barragan-Carrillo, Regina; Viglietti, Giulia; Demeestere, Isabelle; Villarreal-Garza, Cynthia

2017-01-01

Thanks to the improved survival outcomes observed in recent years, a growing attention has been given to the quality of life issues faced by young women with breast cancer such as fertility preservation and concerns related to future pregnancies. However, several challenges remain for young women with breast cancer considering undergoing fertility preservation strategies. Further specific issues on this regard should be taken into account in Latin America, where patients and physicians face particular barriers that hinder the routine adoption of this practice. Hence, further efforts are needed to overcome these deficiencies and improve the correct referral of breast cancer patients to fertility preservation strategies. The aim of the present review is to focus on the risk of anticancer treatment-related premature ovarian failure and infertility in young breast cancer patients, to summarize the current knowledge on the available options for fertility preservation, and to discuss the safety issues of pregnancy in breast cancer survivors. Furthermore, this review aims to highlight the specific clinical challenges in this field encountered by healthcare providers and young breast cancer patients from Latin American countries.

Is This the Carbapenemase Test We've Been Waiting for? A Multicenter Evaluation of the Modified Carbapenem Inactivation Method.

PubMed

Butler-Wu, Susan M; Abbott, April N

2017-08-01

A plethora of phenotypic methods exist for the detection of carbapenemases; however, clinical laboratories have struggled for years with accurate, objective phenotypic detection of carbapenemase activity in Enterobacteriaceae In this issue of the Journal of Clinical Microbiology , V. M. Pierce et al. (J Clin Microbiol 55:2321-2333, 2017, https://doi.org/10.1128/JCM.00193-17) report on a multicenter evaluation of the modified carbapenem inactivation method (mCIM). The high sensitivity, specificity, reproducibility, and ease of interpretation associated with the mCIM for Enterobacteriaceae will likely lead to its adoption by clinical laboratories. Copyright © 2017 American Society for Microbiology.

The new production theory for health care through clinical reengineering: a study of clinical guidelines--Part II.

PubMed

Sharp, J R

1995-01-01

In Part I of this two-part article, in the December 1994 issue of the journal, the author discussed the manufacturing theories of Peter Drucker in terms of their applicability for the health care field. He concluded that Drucker's four principles and practices of manufacturing--statistical quality control, manufacturing accounting, modular organization, and systems approach--do have application to the health care system. Clinical guidelines, a variation on the Drucker theory, are a specific example of the manufacturing process in health. The performance to date of some guidelines and their implications for the health care reform debate are discussed in Part II of the article.

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.

Clinical ethics issues in HIV care in Canada: an institutional ethnographic study.

PubMed

Kaposy, Chris; Greenspan, Nicole R; Marshall, Zack; Allison, Jill; Marshall, Shelley; Kitson, Cynthia

2017-02-06

This is a study involving three HIV clinics in the Canadian provinces of Newfoundland and Labrador, and Manitoba. We sought to identify ethical issues involving health care providers and clinic clients in these settings, and to gain an understanding of how different ethical issues are managed by these groups. We used an institutional ethnographic method to investigate ethical issues in HIV clinics. Our researcher conducted in-depth semi-structured interviews, compiled participant observation notes, and studied health records in order to document ethical issues in the clinics, and to understand how health care providers and clinic clients manage and resolve these issues. We found that health care providers and clinic clients have developed work processes for managing ethical issues of various types: conflicts between client-autonomy and public health priorities ("treatment as prevention"), difficulties associated with the criminalization of nondisclosure of HIV positive status, challenges with non-adherence to HIV treatment, the protection of confidentiality, barriers to treatment access, and negative social determinants of health and well-being. Some ethical issues resulted from structural disadvantages experienced by clinic clients. The most striking findings in our study were the negative social determinants of health and well-being experienced by some clinic clients - such as experiences of violence and trauma, poverty, racism, colonization, homelessness, and other factors affecting well-being such as problematic substance use. These negative determinants were at the root of other ethical issues, and are themselves of ethical concern.

Treatment effect heterogeneity for univariate subgroups in clinical trials: Shrinkage, standardization, or else

PubMed Central

Varadhan, Ravi; Wang, Sue-Jane

2016-01-01

Treatment effect heterogeneity is a well-recognized phenomenon in randomized controlled clinical trials. In this paper, we discuss subgroup analyses with prespecified subgroups of clinical or biological importance. We explore various alternatives to the naive (the traditional univariate) subgroup analyses to address the issues of multiplicity and confounding. Specifically, we consider a model-based Bayesian shrinkage (Bayes-DS) and a nonparametric, empirical Bayes shrinkage approach (Emp-Bayes) to temper the optimism of traditional univariate subgroup analyses; a standardization approach (standardization) that accounts for correlation between baseline covariates; and a model-based maximum likelihood estimation (MLE) approach. The Bayes-DS and Emp-Bayes methods model the variation in subgroup-specific treatment effect rather than testing the null hypothesis of no difference between subgroups. The standardization approach addresses the issue of confounding in subgroup analyses. The MLE approach is considered only for comparison in simulation studies as the “truth” since the data were generated from the same model. Using the characteristics of a hypothetical large outcome trial, we perform simulation studies and articulate the utilities and potential limitations of these estimators. Simulation results indicate that Bayes-DS and Emp-Bayes can protect against optimism present in the naïve approach. Due to its simplicity, the naïve approach should be the reference for reporting univariate subgroup-specific treatment effect estimates from exploratory subgroup analyses. Standardization, although it tends to have a larger variance, is suggested when it is important to address the confounding of univariate subgroup effects due to correlation between baseline covariates. The Bayes-DS approach is available as an R package (DSBayes). PMID:26485117

Clinical supervision of allied health professionals in country South Australia: A mixed methods pilot study.

PubMed

Kumar, Saravana; Osborne, Kate; Lehmann, Tanya

2015-10-01

Recent times have witnessed dramatic changes in health care with overt recognition for quality and safety to underpin health care service delivery. In addition to systems-wide focus, the importance of supporting and mentoring people delivering the care has also been recognised. This can be achieved through quality clinical supervision. In 2010, Country Health South Australia Local Health Network developed a holistic allied health clinical governance structure, which was implemented in 2011. This research reports on emergent findings from the evaluation of the clinical governance structure, which included mandating clinical supervision for all allied health staff. A mixed method approach was chosen with evaluation of the impact of clinical supervision undertaken by a psychometrically sound instrument (Manchester Clinical Supervision Scale 26-item version), collected through an anonymous online survey and qualitative data collected through semistructured interviews and focus groups. Overall, 189 allied health professionals responded to the survey. Survey responses indicated allied health professionals recognised the importance of and valued receiving clinical supervision (normative domain), had levels of trust and rapport with, and were supported by supervisors (restorative domain) and positively affected their delivery of care and improvement in skills (formative domain). Qualitative data identified enablers such as profession specific gains, improved opportunities and consistency for clinical supervision and barriers such as persistent organisational issues, lack of clarity (delineation of roles) and communication issues. The findings from this research highlight that while clinical supervision has an important role to play, it is not a panacea for all the ills of the health care system. © 2015 National Rural Health Alliance Inc.

Molecular and Clinical Issues about the Risk of Venous Thromboembolism in Older Patients: A Focus on Parkinson’s Disease and Parkinsonism

PubMed Central

Tana, Claudio; Lauretani, Fulvio; Ticinesi, Andrea; Prati, Beatrice; Meschi, Tiziana

2018-01-01

Venous thromboembolism (VTE) is a common and potentially life-threatening condition which includes both deep-vein thrombosis (DVT) and pulmonary embolism (PE). VTE has a significant clinical and epidemiological impact in the elderly, and its incidence increases to more than 1% per year in older patients, suggesting the presence of specific age-related risk factors in this population. Immobilization seems to predominate as the main cause in patients admitted for medical acute illness in medicine wards, and there is evidence of a high risk in older patients with immobilization resulting from advanced forms of Parkinson’s disease (PD), regardless of the presence of an acute medical condition. In this review, we would to discuss the recent evidence on clinical, molecular and epidemiological features of VTE in older frail subjects focusing on patients with PD and parkinsonism. We also discuss some therapeutic issues about the risk prevention and we suggest a thorough comprehensive geriatric assessment that can represent an optimal strategy to identify and prevent the VTE risk in these patients. PMID:29701703

The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials.

PubMed

Macrae, Duncan J

2007-05-01

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war crimes trials, more specifically the "Doctors' Trial." From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV/AIDS research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

Why do commercial CT scanners still employ traditional, filtered back-projection for image reconstruction?

PubMed Central

Pan, Xiaochuan; Sidky, Emil Y; Vannier, Michael

2010-01-01

Despite major advances in x-ray sources, detector arrays, gantry mechanical design and especially computer performance, one component of computed tomography (CT) scanners has remained virtually constant for the past 25 years—the reconstruction algorithm. Fundamental advances have been made in the solution of inverse problems, especially tomographic reconstruction, but these works have not been translated into clinical and related practice. The reasons are not obvious and seldom discussed. This review seeks to examine the reasons for this discrepancy and provides recommendations on how it can be resolved. We take the example of field of compressive sensing (CS), summarizing this new area of research from the eyes of practical medical physicists and explaining the disconnection between theoretical and application-oriented research. Using a few issues specific to CT, which engineers have addressed in very specific ways, we try to distill the mathematical problem underlying each of these issues with the hope of demonstrating that there are interesting mathematical problems of general importance that can result from in depth analysis of specific issues. We then sketch some unconventional CT-imaging designs that have the potential to impact on CT applications, if the link between applied mathematicians and engineers/physicists were stronger. Finally, we close with some observations on how the link could be strengthened. There is, we believe, an important opportunity to rapidly improve the performance of CT and related tomographic imaging techniques by addressing these issues. PMID:20376330

TOPICAL REVIEW: Why do commercial CT scanners still employ traditional, filtered back-projection for image reconstruction?

NASA Astrophysics Data System (ADS)

Pan, Xiaochuan; Sidky, Emil Y.; Vannier, Michael

2009-12-01

Despite major advances in x-ray sources, detector arrays, gantry mechanical design and especially computer performance, one component of computed tomography (CT) scanners has remained virtually constant for the past 25 years—the reconstruction algorithm. Fundamental advances have been made in the solution of inverse problems, especially tomographic reconstruction, but these works have not been translated into clinical and related practice. The reasons are not obvious and seldom discussed. This review seeks to examine the reasons for this discrepancy and provides recommendations on how it can be resolved. We take the example of field of compressive sensing (CS), summarizing this new area of research from the eyes of practical medical physicists and explaining the disconnection between theoretical and application-oriented research. Using a few issues specific to CT, which engineers have addressed in very specific ways, we try to distill the mathematical problem underlying each of these issues with the hope of demonstrating that there are interesting mathematical problems of general importance that can result from in depth analysis of specific issues. We then sketch some unconventional CT-imaging designs that have the potential to impact on CT applications, if the link between applied mathematicians and engineers/physicists were stronger. Finally, we close with some observations on how the link could be strengthened. There is, we believe, an important opportunity to rapidly improve the performance of CT and related tomographic imaging techniques by addressing these issues.

Bioethics education in clinical settings: theory and practice of the dilemma method of moral case deliberation.

PubMed

Stolper, Margreet; Molewijk, Bert; Widdershoven, Guy

2016-07-22

Moral Case Deliberation is a specific form of bioethics education fostering professionals' moral competence in order to deal with their moral questions. So far, few studies focus in detail on Moral Case Deliberation methodologies and their didactic principles. The dilemma method is a structured and frequently used method in Moral Case Deliberation that stimulates methodological reflection and reasoning through a systematic dialogue on an ethical issue experienced in practice. In this paper we present a case-study of a Moral Case Deliberation with the dilemma method in a health care institution for people with an intellectual disability, describing the theoretical background and the practical application of the dilemma method. The dilemma method focuses on moral experiences of participants concerning a concrete dilemma in practice. By an in-depth description of each of the steps of the deliberation process, we elucidate the educational value and didactics of this specific method. The didactics and methodical steps of the dilemma method both supported and structured the dialogical reflection process of the participants. The process shows that the participants learned to recognize the moral dimension of the issue at stake and were able to distinguish various perspectives and reasons in a systematic manner. The facilitator played an important role in the learning process of the participants, by assisting them in focusing on and exploring moral aspects of the case. The reflection and learning process, experienced by the participants, shows competency-based characteristics. The role of the facilitator is that of a Socratic teacher with specific knowledge and skills, fostering reflection, inquiry and dialogue. The specific didactics of the dilemma method is well suited for teaching bioethics in clinical settings. The dilemma method follows an inductive learning approach through a dialogical moral inquiry in which participants develop not only knowledge but also skills, attitude and character. The role of a trained facilitator and a specific view on teaching and practicing ethics are essential when using the dilemma method in teaching health care professionals how to reflect on their own moral issues in practice.

Examining the Role of Mental Health and Clinical Issues within Talent Development

PubMed Central

Hill, Andy; MacNamara, Áine; Collins, Dave; Rodgers, Sheelagh

2016-01-01

Although significant research supports the association between physical activity and mental wellbeing, current literature acknowledges that athletes are no less susceptible to mental illness than the general population. Despite welcomed initiatives aimed at improving mental health within elite sport, these programs often fail to target young athletes; an important concern given that the genesis of many mental illnesses are recognized to occur during this critical period. Given the importance of early intervention and effective treatment, and the potentially devastating consequences of clinical issues going undiagnosed, the implications for talent identification and development (TID) become obvious. With this in mind, this study sought to examine the range of mental health issues that may impact upon developing athletes and potential consequences for the development process, specific risk and protective factors associated with talent development, along with an examination of current practices concerning the identification of mental health issues in such environments. Qualitative interviews were conducted with purposively sampled clinicians (n = 8) experienced in working with adolescents and/or young athletes. Inductive content analysis was undertaken, identifying four main themes: key behavioral indicators; associated risk factors; associated protective factors; and issues around identification and diagnosis. Key behavioral indicators included behavioral change, along with behaviors associated with eating disorders, anxiety and depression. Risk factors centered on family background, the performance environment, and issues surrounding adolescence. Protective factors were primarily social in nature. Finally, a lack of awareness and understanding of clinical issues, multiple causes of symptoms, non-disclosure and the need for triangulation of assessment were identified. The need for improved identification and intervention strategies was apparent, with coaches identified as well placed to detect general “warning signs” such as behavioral change. Short of integrating trained clinicians into talent development environments, as part of a triangulation process, ecologically validated assessment tools—coupled with appropriate training and signposting—could offer a practical way of flagging potential issues in developing athletes. The need for the development of such an instrument is therefore apparent. Finally, education around the influential role of family is also recommended in order to promote the protective elements and mitigate risk factors. PMID:26793153

Examining the Role of Mental Health and Clinical Issues within Talent Development.

PubMed

Hill, Andy; MacNamara, Áine; Collins, Dave; Rodgers, Sheelagh

2015-01-01

Although significant research supports the association between physical activity and mental wellbeing, current literature acknowledges that athletes are no less susceptible to mental illness than the general population. Despite welcomed initiatives aimed at improving mental health within elite sport, these programs often fail to target young athletes; an important concern given that the genesis of many mental illnesses are recognized to occur during this critical period. Given the importance of early intervention and effective treatment, and the potentially devastating consequences of clinical issues going undiagnosed, the implications for talent identification and development (TID) become obvious. With this in mind, this study sought to examine the range of mental health issues that may impact upon developing athletes and potential consequences for the development process, specific risk and protective factors associated with talent development, along with an examination of current practices concerning the identification of mental health issues in such environments. Qualitative interviews were conducted with purposively sampled clinicians (n = 8) experienced in working with adolescents and/or young athletes. Inductive content analysis was undertaken, identifying four main themes: key behavioral indicators; associated risk factors; associated protective factors; and issues around identification and diagnosis. Key behavioral indicators included behavioral change, along with behaviors associated with eating disorders, anxiety and depression. Risk factors centered on family background, the performance environment, and issues surrounding adolescence. Protective factors were primarily social in nature. Finally, a lack of awareness and understanding of clinical issues, multiple causes of symptoms, non-disclosure and the need for triangulation of assessment were identified. The need for improved identification and intervention strategies was apparent, with coaches identified as well placed to detect general "warning signs" such as behavioral change. Short of integrating trained clinicians into talent development environments, as part of a triangulation process, ecologically validated assessment tools-coupled with appropriate training and signposting-could offer a practical way of flagging potential issues in developing athletes. The need for the development of such an instrument is therefore apparent. Finally, education around the influential role of family is also recommended in order to promote the protective elements and mitigate risk factors.

Clinical uses of brain natriuretic peptide in diagnosing and managing heart failure.

PubMed

Anderson, Kelley M

2008-06-01

To review current issues in the diagnosis, prognosis, and management of heart failure (HF), focusing on the clinical use of brain natriuretic peptide (BNP) as a diagnostic marker. Selective review of scientific literature and clinical practice guidelines. BNP is a useful clinical tool for the diagnosis, prognosis, and management of HF patients. Studies have consistently demonstrated high sensitivity, specificity, and negative predictive value of BNP levels in diagnostic situations. BNP cannot differentiate between systolic and diastolic HF. BNP can be used to assist in diagnosing HF in emergency and outpatient situations, particularly when the presenting symptom is dyspnea; determining HF prognosis, including predicting death and cardiac events; and potentially managing individuals with HF by determining safe discharge levels from acute care to avoid readmissions. BNP levels can vary depending on multiple confounders; therefore, clinical interpretation can be difficult.

Muscle dysmorphia: methodological issues, implications for research.

PubMed

Suffolk, Mark T; Dovey, Terence M; Goodwin, Huw; Meyer, Caroline

2013-01-01

Muscle dysmorphia is a male-dominated, body image-related psychological condition. Despite continued investigation, contention surrounds the nosological status of this disorder. The aim of this article was to review the literature on muscle dysmorphia to provide a qualitative account of methodological issues that may inhibit our understanding. Key areas relating to non-standardized participant groups, measuring instruments, and terminology were identified as potentially inhibiting symptom coherence and diagnostic reliability. New measuring instruments validated with clinical samples and carefully described participant groups, standardized terminology, and a greater emphasis on prospective longitudinal research with specific sub groups of the weight training community would be of interest to the field.

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.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rivard, M.

With the recent introduction of heterogeneity correction algorithms for brachytherapy, the AAPM community is still unclear on how to commission and implement these into clinical practice. The recently-published AAPM TG-186 report discusses important issues for clinical implementation of these algorithms. A charge of the AAPM-ESTRO-ABG Working Group on MBDCA in Brachytherapy (WGMBDCA) is the development of a set of well-defined test case plans, available as references in the software commissioning process to be performed by clinical end-users. In this practical medical physics course, specific examples on how to perform the commissioning process are presented, as well as descriptions of themore » clinical impact from recent literature reporting comparisons of TG-43 and heterogeneity-based dosimetry. Learning Objectives: Identify key clinical applications needing advanced dose calculation in brachytherapy. Review TG-186 and WGMBDCA guidelines, commission process, and dosimetry benchmarks. Evaluate clinical cases using commercially available systems and compare to TG-43 dosimetry.« less

Does nutrition support have a role in managing cancer cachexia?

PubMed

Laviano, Alessandro; Di Lazzaro Giraldi, Gianluca; Koverech, Angela

2016-12-01

Cachexia is a negative prognostic factor in cancer patients. The pathogenesis is related to a variable combination of reduced food intake and metabolic changes. However, whether nutritional support may contribute to effectively prevent and treat cachexia remains a debated issue. Consistent evidence demonstrates that anabolic windows of opportunity occur during the clinical trajectory of cancer patients. Also, the use of specific nutrients, namely omega-3 fatty acids, may enhance the efficacy of nutritional support when tumor-driven inflammatory response is high. Of greater interest, it is now becoming clearer that the use of nutritional support at key time points in the clinical journey of cancer patients (i.e., perioperative period) may extend its clinical benefits beyond those on nutritional status. Nutritional support plays a role in managing cancer cachexia, when it is timely delivered, when it provides adequate amounts of calories and proteins, and when it is part of a concurrent palliative care approach. Specific nutrients, that is, omega-3 fatty acids, may help in those cancer patients with high-inflammatory response, and may also contribute to positively influence long-term clinical outcomes.

Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy.

PubMed

Roberts, Jeffrey N; Gruber, Marion F

2015-02-18

Despite supportive public health policies (e.g., ACIP recommendations), the potential for providing clinical benefit through maternal immunization has yet to be fully realized. For vaccines already licensed and approved for use in adults, specific FDA approval for use during pregnancy to prevent disease in the mother and/or infant may have a significant impact on uptake and usage in pregnant women. In addition, for either a licensed vaccine or a novel vaccine, FDA approval for use during pregnancy would result in labeling that would serve as a resource for practitioners and would facilitate the safe and effective use of the vaccine during pregnancy. In the U.S., while many vaccines are approved for use in adults and most are not contraindicated for use in pregnant women, no vaccine is licensed for use specifically during pregnancy. Among the perceived obstacles hindering the clinical development of vaccines for use in pregnancy, regulatory issues are frequently cited. One aim of this article is to address the perceived regulatory obstacles. General concepts and regulatory considerations for clinical safety and effectiveness evaluations for vaccines indicated for use during pregnancy will be discussed. This discussion is not intended to establish data requirements or to articulate agency policy or guidance regarding specific vaccine products. Published by Elsevier Ltd.

Superficial and deep lymph node dissection for stage III cutaneous melanoma: clinical outcome and prognostic factors

PubMed Central

2013-01-01

Background The aims of this retrospective analysis were to evaluate the effect of combined superficial and deep groin dissection on disease-free and melanoma-specific survival, and to identify the most important factors for predicting the involvement of deep nodes according to clinically or microscopically detected nodal metastases. Methods Between January 1996 and December 2005, 133 consecutive patients with groin lymph node metastases underwent superficial and deep dissection at the National Cancer Institute, Naples. Lymph node involvement was clinically evident in 84 patients and detected by sentinel node biopsy in 49 cases. Results The 5-year disease-free survival was significantly better for patients with superficial lymph node metastases than for patients with involvement of both superficial and deep lymph nodes (34.9% vs. 19.0%; P = 0.001). The 5-year melanoma-specific survival was also significantly better for patients with superficial node metastases only (55.6% vs. 33.3%; P = 0.001). Conclusions Metastasis in the deep nodes is the strongest predictor of both disease-free and melanoma-specific survival. Deep groin dissection should be considered for all patients with groin clinical nodal involvement, but might be spared in patients with a positive sentinel node. Prospective studies will clarify the issue further. PMID:23379355

Superficial and deep lymph node dissection for stage III cutaneous melanoma: clinical outcome and prognostic factors.

PubMed

Mozzillo, Nicola; Caracò, Corrado; Marone, Ugo; Di Monta, Gianluca; Crispo, Anna; Botti, Gerardo; Montella, Maurizio; Ascierto, Paolo Antonio

2013-02-04

The aims of this retrospective analysis were to evaluate the effect of combined superficial and deep groin dissection on disease-free and melanoma-specific survival, and to identify the most important factors for predicting the involvement of deep nodes according to clinically or microscopically detected nodal metastases. Between January 1996 and December 2005, 133 consecutive patients with groin lymph node metastases underwent superficial and deep dissection at the National Cancer Institute, Naples. Lymph node involvement was clinically evident in 84 patients and detected by sentinel node biopsy in 49 cases. The 5-year disease-free survival was significantly better for patients with superficial lymph node metastases than for patients with involvement of both superficial and deep lymph nodes (34.9% vs. 19.0%; P = 0.001). The 5-year melanoma-specific survival was also significantly better for patients with superficial node metastases only (55.6% vs. 33.3%; P = 0.001). Metastasis in the deep nodes is the strongest predictor of both disease-free and melanoma-specific survival. Deep groin dissection should be considered for all patients with groin clinical nodal involvement, but might be spared in patients with a positive sentinel node. Prospective studies will clarify the issue further.

Antibody–Drug Conjugates for Cancer Therapy

PubMed Central

Parslow, Adam C.; Parakh, Sagun; Lee, Fook-Thean; Gan, Hui K.; Scott, Andrew M.

2016-01-01

Antibody–drug conjugates (ADCs) take advantage of the specificity of a monoclonal antibody to deliver a linked cytotoxic agent directly into a tumour cell. The development of these compounds provides exciting opportunities for improvements in patient care. Here, we review the key issues impacting on the clinical success of ADCs in cancer therapy. Like many other developing therapeutic classes, there remain challenges in the design and optimisation of these compounds. As the clinical applications for ADCs continue to expand, key strategies to improve patient outcomes include better patient selection for treatment and the identification of mechanisms of therapy resistance. PMID:28536381

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.

Medicare program; revisions to payment policies under the physician fee schedule, clinical laboratory fee schedule & other revisions to Part B for CY 2014. Final rule with comment period.

PubMed

2013-12-10

This major final rule with comment period addresses changes to the physician fee schedule, clinical laboratory fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule with comment period also includes a discussion in the Supplementary Information regarding various programs. (See the Table of Contents for a listing of the specific issues addressed in the final rule with comment period.)

Therapeutic clinical applications of reactor-produced radioisotopes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Knapp, F.F. Jr.

1997-12-01

One of the most rapidly growing areas of clinical nuclear medicine is the therapeutic use of radioisotopes for applications in oncology, rheumatology and, more recently, interventional cardiology. With the rapidly increasing development and evaluation of new agents, their introduction into clinical use, and commercialization, the availability of high levels of therapeutic reactor-produced neutron-rich radioisotopes is of increasing importance. The goals of this paper are to discuss the issues associated with optimization of the production and processing of reactor-produced radioisotopes for therapy, with special emphasis on {sup 188}W, and the optimization of the use of the {sup 188}W/{sup 188}Re generator. Inmore » addition, other key examples of therapeutic radioisotopes of current interest and their specific clinical applications are discussed.« less

Review of guidelines and literature for handling missing data in longitudinal clinical trials with a case study.

PubMed

Liu, M; Wei, L; Zhang, J

2006-01-01

Missing data in clinical trials are inevitable. We highlight the ICH guidelines and CPMP points to consider on missing data. Specifically, we outline how we should consider missing data issues when designing, planning and conducting studies to minimize missing data impact. We also go beyond the coverage of the above two documents, provide a more detailed review of the basic concepts of missing data and frequently used terminologies, and examples of the typical missing data mechanism, and discuss technical details and literature for several frequently used statistical methods and associated software. Finally, we provide a case study where the principles outlined in this paper are applied to one clinical program at protocol design, data analysis plan and other stages of a clinical trial.

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.

The dental amalgam controversy: a review

PubMed Central

Feuer, George; Injeyan, H Stephen

1996-01-01

In spite of the long history of mercury amalgam as a dental restorative material, its use continues to be controversial. Mercury vapour is continuously released from dental amalgam and is ultimately absorbed into a variety of tissues. Experimental data have demonstrated that the uptake, tissue retention and excretion of mercury from dental amalgam is significant. Evidence has accumulated indicating a relationship between tissue mercury levels and a multitude of clinical manifestations. However, the clinical significance of mercury toxicity from dental amalgams is a matter for debate. The literature is devoid of randomized clinical trials that are rigorously designed to address this issue. Thus, although research data renders the notion of amalgam safety questionable, the dental community appears determined to continue its use as long as unequivocal evidence correlating amalgam mercury toxicity to specific clinical conditions is lacking.

A systematic review of ethical issues in vaccine studies involving pregnant women.

PubMed

Beeler, Jennifer A; Lambach, Philipp; Fulton, T Roice; Narayanan, Divya; Ortiz, Justin R; Omer, Saad B

2016-08-02

Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy. To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women. We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories. Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs. This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs developed to prevent disease in newborn children in low- and middle-income countries.

Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.

PubMed

Rasoal, Dara; Skovdahl, Kirsti; Gifford, Mervyn; Kihlgren, Annica

2017-12-01

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a "bottom-up" perspective might give healthcare personnel opportunities to think and reflect more than a "top-down" perspective. A "bottom-up" approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a "top-down" approach risks removing such moral responsibility.

Prostate cancer diagnostics: Clinical challenges and the ongoing need for disruptive and effective diagnostic tools.

PubMed

Sharma, Shikha; Zapatero-Rodríguez, Julia; O'Kennedy, Richard

The increased incidence and the significant health burden associated with carcinoma of the prostate have led to substantial changes in its diagnosis over the past century. Despite technological advancements, the management of prostate cancer has become progressively more complex and controversial for both early and late-stage disease. The limitations and potential harms associated with the use of prostate-specific antigen (PSA) as a diagnostic marker have stimulated significant investigation of numerous novel biomarkers that demonstrate varying capacities to detect prostate cancer and can decrease unnecessary biopsies. However, only a few of these markers have been approved for specific clinical settings while the others have not been adequately validated for use. This review systematically and critically assesses ongoing issues and emerging challenges in the current state of prostate cancer diagnostic tools and the need for disruptive next generation tools based on analysis of combinations of these biomarkers to enhance predictive accuracy which will benefit clinical diagnostics and patient welfare. Copyright © 2016. Published by Elsevier Inc.

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.

Have the Answers to Common Legal Questions Concerning Nutrition Support Changed Over the Past Decade? 10 Questions for 10 Years.

PubMed

Barrocas, Albert; Cohen, Michael L

2016-06-01

Clinical nutrition specialists (CNSs) are often confronted with technological, ethical, and legal questions, that is, what can be done technologically, what should be done ethically, and what must be done legally, which conflict at times. The conflict represents a "troubling trichotomy" as discussed in the lead article of this issue of Nutrition in Clinical Practice (NCP). During Clinical Nutrition Week in 2006, a symposium covering these 3 topics was presented, and later that year, an article covering the same topic was published in NCP In this article, we revisit several legal questions/issues that were raised 10 years ago and discuss current answers and approaches. Some of the answers remain unchanged. Other answers have been modified by additional legislation, court decisions, or regulations. In addition, new questions/issues have arisen. Some of the most common questions regarding nutrition support involve the following: liability, informed consent, medical decisional incapacity vs legal competence, advance directive specificity, surrogate decision making, physician orders for life-sustaining treatment and electronic medical orders for life-sustaining treatment, legal definition of death, patient vs family decision making, the noncompliant patient, and elder abuse obligations. In the current healthcare environment, these questions and issues are best addressed via a transdisciplinary team that focuses on function rather than form. The CNS can play a pivotal role in dealing with these challenges by applying the acronym ACT: being Accountable and Communicating with all stakeholders while actively participating as an integral part of the transdisciplinary Team. © 2016 American Society for Parenteral and Enteral Nutrition.

Clinical indications for antibiotic use in Danish general practice: results from a nationwide electronic prescription database.

PubMed

Aabenhus, Rune; Hansen, Malene Plejdrup; Siersma, Volkert; Bjerrum, Lars

2017-06-01

To assess the availability and applicability of clinical indications from electronic prescriptions on antibiotic use in Danish general practice. Retrospective cohort register-based study including the Danish National Prescription Register. Population-based study of routine electronic antibiotic prescriptions from Danish general practice. All 975,626 patients who redeemed an antibiotic prescription at outpatient pharmacies during the 1-year study period (July 2012 to June 2013). Number of prescriptions per clinical indication. Number of antibiotic prescriptions per 1000 inhabitants by age and gender. Logistic regression analysis estimated the association between patient and provider factors and missing clinical indications on antibiotic prescriptions. A total of 2.381.083 systemic antibiotic prescriptions were issued by Danish general practitioners in the study period. We identified three main clinical entities: urinary tract infections (n = 506.634), respiratory tract infections (n = 456.354) and unspecified infections (n = 416.354). Women were more exposed to antibiotics than men. Antibiotic use was high in children under 5 years and even higher in elderly people. In 32% of the issued prescriptions, the clinical indication was missing. This was mainly associated with antibiotic types. We found that a prescription for a urinary tract agent without a specific clinical indication was uncommon. Clinical indications from electronic prescriptions are accessible and available to provide an overview of drug use, in casu antibiotic prescriptions, in Danish general practice. These clinical indications may be further explored in detail to assess rational drug use and congruence with guidelines, but validation and optimisation of the system is preferable.

Learning and memory performance in a cohort of clinically referred breast cancer survivors: the role of attention versus forgetting in patient-reported memory complaints.

PubMed

Root, James C; Ryan, Elizabeth; Barnett, Gregory; Andreotti, Charissa; Bolutayo, Kemi; Ahles, Tim

2015-05-01

While forgetfulness is widely reported by breast cancer survivors, studies documenting objective memory performance yield mixed, largely inconsistent, results. Failure to find consistent, objective memory issues may be due to the possibility that cancer survivors misattribute their experience of forgetfulness to primary memory issues rather than to difficulties in attention at the time of learning. To clarify potential attention issues, factor scores for Attention Span, Learning Efficiency, Delayed Memory, and Inaccurate Memory were analyzed for the California Verbal Learning Test-Second Edition (CVLT-II) in 64 clinically referred breast cancer survivors with self-reported cognitive complaints; item analysis was conducted to clarify specific contributors to observed effects, and contrasts between learning and recall trials were compared with normative data. Performance on broader cognitive domains is also reported. The Attention Span factor, but not Learning Efficiency, Delayed Memory, or Inaccurate Memory factors, was significantly affected in this clinical sample. Contrasts between trials were consistent with normative data and did not indicate greater loss of information over time than in the normative sample. Results of this analysis suggest that attentional dysfunction may contribute to subjective and objective memory complaints in breast cancer survivors. These results are discussed in the context of broader cognitive effects following treatment for clinicians who may see cancer survivors for assessment. Copyright © 2014 John Wiley & Sons, Ltd.

Predictive validity of behavioural animal models for chronic pain

PubMed Central

Berge, Odd-Geir

2011-01-01

Rodent models of chronic pain may elucidate pathophysiological mechanisms and identify potential drug targets, but whether they predict clinical efficacy of novel compounds is controversial. Several potential analgesics have failed in clinical trials, in spite of strong animal modelling support for efficacy, but there are also examples of successful modelling. Significant differences in how methods are implemented and results are reported means that a literature-based comparison between preclinical data and clinical trials will not reveal whether a particular model is generally predictive. Limited reports on negative outcomes prevents reliable estimate of specificity of any model. Animal models tend to be validated with standard analgesics and may be biased towards tractable pain mechanisms. But preclinical publications rarely contain drug exposure data, and drugs are usually given in high doses and as a single administration, which may lead to drug distribution and exposure deviating significantly from clinical conditions. The greatest challenge for predictive modelling is, however, the heterogeneity of the target patient populations, in terms of both symptoms and pharmacology, probably reflecting differences in pathophysiology. In well-controlled clinical trials, a majority of patients shows less than 50% reduction in pain. A model that responds well to current analgesics should therefore predict efficacy only in a subset of patients within a diagnostic group. It follows that successful translation requires several models for each indication, reflecting critical pathophysiological processes, combined with data linking exposure levels with effect on target. LINKED ARTICLES This article is part of a themed issue on Translational Neuropharmacology. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2011.164.issue-4 PMID:21371010

Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice.

PubMed

True, Lawrence D

2014-03-01

Paralleling the growth of ever more cost efficient methods to sequence the whole genome in minute fragments of tissue has been the identification of increasingly numerous molecular abnormalities in cancers--mutations, amplifications, insertions and deletions of genes, and patterns of differential gene expression, i.e., overexpression of growth factors and underexpression of tumor suppressor genes. These abnormalities can be translated into assays to be used in clinical decision making. In general terms, the result of such an assay is subject to a large number of variables regarding the characteristics of the available sample, particularities of the used assay, and the interpretation of the results. This review discusses the effects of these variables on assays of tissue-based biomarkers, classified by macromolecule--DNA, RNA (including micro RNA, messenger RNA, long noncoding RNA, protein, and phosphoprotein). Since the majority of clinically applicable biomarkers are immunohistochemically detectable proteins this review focuses on protein biomarkers. However, the principles outlined are mostly applicable to any other analyte. A variety of preanalytical variables impacts on the results obtained, including analyte stability (which is different for different analytes, i.e., DNA, RNA, or protein), period of warm and of cold ischemia, fixation time, tissue processing, sample storage time, and storage conditions. In addition, assay variables play an important role, including reagent specificity (notably but not uniquely an issue concerning antibodies used in immunohistochemistry), technical components of the assay, quantitation, and assay interpretation. Finally, appropriateness of an assay for clinical application is an important issue. Reference is made to publicly available guidelines to improve on biomarker development in general and requirements for clinical use in particular. Strategic goals are formulated in order to improve on the quality of biomarker reporting, including issues of analyte quality, experimental detail, assay efficiency and precision, and assay appropriateness.

The utility of ductal lavage in breast cancer detection and risk assessment

PubMed Central

Domchek, Susan M

2002-01-01

Ductal lavage (DL) permits noninvasive retrieval of epithelial cells from the breast. Clinical development of this technique has been fueled largely by its potential, as yet unproven, to improve detection of breast cancer and definition of individual risk for development of breast cancer. Early studies demonstrate the feasibility of performing this technique, provide data on cellular yield and findings, and demonstrate the ability to measure molecular markers in DL fluid. However, the sensitivity and specificity of DL for the detection of breast cancer remains unknown, as does the significance of atypia, particularly mild atypia, when found in DL fluid. Although DL appears safe and the device is approved by the US Food and Drug Administration, DL is still best utilized in the setting of clinical trials designed to resolve issues of sensitivity, specificity, and localization. PMID:11879562

A patient workflow management system built on guidelines.

PubMed Central

Dazzi, L.; Fassino, C.; Saracco, R.; Quaglini, S.; Stefanelli, M.

1997-01-01

To provide high quality, shared, and distributed medical care, clinical and organizational issues need to be integrated. This work describes a methodology for developing a Patient Workflow Management System, based on a detailed model of both the medical work process and the organizational structure. We assume that the medical work process is represented through clinical practice guidelines, and that an ontological description of the organization is available. Thus, we developed tools 1) for acquiring the medical knowledge contained into a guideline, 2) to translate the derived formalized guideline into a computational formalism, precisely a Petri Net, 3) to maintain different representation levels. The high level representation guarantees that the Patient Workflow follows the guideline prescriptions, while the low level takes into account the specific organization characteristics and allow allocating resources for managing a specific patient in daily practice. PMID:9357606

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.

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.

Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA).

PubMed

Rodríguez-Artalejo, Fernando; Guallar, Eliseo; Borghi, Claudio; Dallongeville, Jean; De Backer, Guy; Halcox, Julian P; Hernández-Vecino, Ramón; Jiménez, Francisco Javier; Massó-González, Elvira L; Perk, Joep; Steg, Philippe Gabriel; Banegas, José R

2010-06-30

The EURIKA study aims to assess the status of primary prevention of cardiovascular disease (CVD) across Europe. Specifically, it will determine the degree of control of cardiovascular risk factors in current clinical practice in relation to the European guidelines on cardiovascular prevention. It will also assess physicians' knowledge and attitudes about CVD prevention as well as the barriers impeding effective risk factor management in clinical practice. Cross-sectional study conducted simultaneously in 12 countries across Europe. The study has two components: firstly at the physician level, assessing eight hundred and nine primary care and specialist physicians with a daily practice in CVD prevention. A physician specific questionnaire captures information regarding physician demographics, practice settings, cardiovascular prevention beliefs and management. Secondly at the patient level, including 7641 patients aged 50 years or older, free of clinical CVD and with at least one classical risk factor, enrolled by the participating physicians. A patient-specific questionnaire captures information from clinical records and patient interview regarding sociodemographic data, CVD risk factors, and current medications. Finally, each patient provides a fasting blood sample, which is sent to a central laboratory for measuring serum lipids, apolipoproteins, hemoglobin-A1c, and inflammatory biomarkers. Primary prevention of CVD is an extremely important clinical issue, with preventable circulatory diseases remaining the leading cause of major disease burden. The EURIKA study will provide key information to assess effectiveness of and attitudes toward primary prevention of CVD in Europe. A transnational study creates opportunities for benchmarking good clinical practice across countries and improving outcomes. (ClinicalTrials.gov number, NCT00882336).

Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

PubMed

Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

2017-12-05

The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Ligand-targeted delivery of small interfering RNAs to malignant cells and tissues.

PubMed

Thomas, Mini; Kularatne, Sumith A; Qi, Longwu; Kleindl, Paul; Leamon, Christopher P; Hansen, Michael J; Low, Philip S

2009-09-01

Potential clinical applications of small interfering RNA (siRNA) are hampered primarily by delivery issues. We have successfully addressed the delivery problems associated with off-site targeting of highly toxic chemotherapeutic agents by attaching the drugs to tumor-specific ligands that will carry the attached cargo into the desired cancer cell. Indeed, several such tumor-targeted drugs are currently undergoing human clinical trials. We now show that efficient targeting of siRNA to malignant cells and tissues can be achieved by covalent conjugation of small-molecular-weight, high-affinity ligands, such as folic acid and DUPA (2-[3-(1, 3-dicarboxy propyl)-ureido] pentanedioic acid), to siRNA. The former ligand binds a folate receptor that is overexpressed on a variety of cancers, whereas the latter ligand binds to prostate-specific membrane antigen that is overexpressed specifically on prostate cancers and the neovasculature of all solid tumors. Using these ligands, we show remarkable receptor-mediated targeting of siRNA to cancer tissues in vitro and in vivo.

Behavioral medicine and clinical health psychology: introduction to the special issue.

PubMed

Christensen, Alan J; Nezu, Arthur M

2013-04-01

This issue represents the 4th Journal of Consulting and Clinical Psychology special issue on behavioral medicine and clinical health psychology over the past 4 decades. Recent developments in health care policy, as well as in the maturation of the science, make a special issue in this area particularly timely. This collection includes state of the clinical science reviews, reports of clinical trials, and articles addressing theory and methods in behavioral medicine and clinical health psychology. A multilevel, ecological perspective that considers multiple levels of influences (e.g., cultural influences on behavior-health linkages, individual differences) is salient throughout many of the articles. Our hope is that this sampling of this broad field, and coverage of some key issues and areas, will play a role in stimulating the next 10 years of research, practice, and policy implementation in behavioral medicine and clinical health psychology.

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

Towards soft robotic devices for site-specific drug delivery.

PubMed

Alici, Gursel

2015-01-01

Considerable research efforts have recently been dedicated to the establishment of various drug delivery systems (DDS) that are mechanical/physical, chemical and biological/molecular DDS. In this paper, we report on the recent advances in site-specific drug delivery (site-specific, controlled, targeted or smart drug delivery are terms used interchangeably in the literature, to mean to transport a drug or a therapeutic agent to a desired location within the body and release it as desired with negligibly small toxicity and side effect compared to classical drug administration means such as peroral, parenteral, transmucosal, topical and inhalation) based on mechanical/physical systems consisting of implantable and robotic drug delivery systems. While we specifically focus on the robotic or autonomous DDS, which can be reprogrammable and provide multiple doses of a drug at a required time and rate, we briefly cover the implanted DDS, which are well-developed relative to the robotic DDS, to highlight the design and performance requirements, and investigate issues associated with the robotic DDS. Critical research issues associated with both DDSs are presented to describe the research challenges ahead of us in order to establish soft robotic devices for clinical and biomedical applications.

Issues in collecting, processing and storing human tissues and associated information to support biomedical research.

PubMed

Grizzle, William E; Bell, Walter C; Sexton, Katherine C

2010-01-01

The availability of human tissues to support biomedical research is critical to advance translational research focused on identifying and characterizing approaches to individualized (personalized) medical care. Providing such tissues relies on three acceptable models - a tissue banking model, a prospective collection model and a combination of these two models. An unacceptable model is the "catch as catch can" model in which tissues are collected, processed and stored without goals or a plan or without standard operating procedures, i.e., portions of tissues are collected as available and processed and stored when time permits. In the tissue banking model, aliquots of tissues are collected according to SOPs. Usually specific sizes and types of tissues are collected and processed (e.g., 0.1 gm of breast cancer frozen in OCT). Using the banking model, tissues may be collected that may not be used and/or do not meet specific needs of investigators; however, at the time of an investigator request, tissues are readily available as is clinical information including clinical outcomes. In the model of prospective collection, tissues are collected based upon investigator requests including specific requirements of investigators. For example, the investigator may request that two 0.15 gm matching aliquots of breast cancer be minced while fresh, put in RPMI media with and without fetal calf serum, cooled to 4°C and shipped to the investigator on wet ice. Thus, the tissues collected prospectively meet investigator needs, all collected specimens are utilized and storage of specimens is minimized; however, investigators must wait until specimens are collected, and if needed, for clinical outcome. The operation of any tissue repository requires well trained and dedicated personnel. A quality assurance program is required which provides quality control information on the diagnosis of a specimen that is matched specifically to the specimen provided to an investigator instead of an overall diagnosis of the specimen via a surgical pathology report. This is necessary because a specific specimen may not match the diagnosis of the case due to many factors such as necrosis, unsuspected tumor invasion of apparently normal tissue, and areas of fibrosis which are mistaken grossly for tumor. Aliquots for quality control (QC) may or may not be collected at the time of collection and in some cases, QC may not occur until specimens are distributed to investigators. In establishing a tumor repository, multiple issues need to be considered. These include the available resources, long term support, space and equipment. The needs of the potential users need to be identified as to the types of tissues and services needed and the annotation expected. Other specific issues to be considered include collection of specimens potentially infected with blood borne pathogens (e.g., hepatitis B), charge back mechanisms, informatics needs and support, and investigator requirements (e.g., recognition of repository contributions in publications). In general, the repository should not perform the research of the investigators, but should provide the infrastructure necessary to support the research of the investigator. Thus, the goals of the repository must be established. Similarly, ethical and regulatory issues must be evaluated. In general, tissue repositories need ethical (e.g., IRB) and privacy (e.g., HIPAA) review. Also, safety issues need to be considered as well as how biohazards will be addressed by investigator-users. Considerations involving the transfer of specimens to other organization usually require a material transfer agreement (MTA). A MTA should address biohazards as well as indemnification. Thus, many issues must be considered and addressed in order to establish and operate successfully a biorepository.

Research and developing countries: hopes and hypes.

PubMed

Moazam, Farhat

2006-01-01

The paper outlines the universal problem of ensuring ethical practices in human subject research, and focuses on specific difficulties faced in the developing world with particular reference to Pakistan. It discusses the influence of traditional and hierarchical social norms of physician-patient relationships in heightening these problems. Two emerging issues of specific concern in Pakistan are described: an exponential rise in multinational clinical drug trials, and commercial ventures offering unproven stem cell "therapy" for all kinds of diseases. The importance of introducing ethical practices in research within the context of local cultural and socioeconomic realities is highlighted.

Cardiac imaging: working towards fully-automated machine analysis & interpretation.

PubMed

Slomka, Piotr J; Dey, Damini; Sitek, Arkadiusz; Motwani, Manish; Berman, Daniel S; Germano, Guido

2017-03-01

Non-invasive imaging plays a critical role in managing patients with cardiovascular disease. Although subjective visual interpretation remains the clinical mainstay, quantitative analysis facilitates objective, evidence-based management, and advances in clinical research. This has driven developments in computing and software tools aimed at achieving fully automated image processing and quantitative analysis. In parallel, machine learning techniques have been used to rapidly integrate large amounts of clinical and quantitative imaging data to provide highly personalized individual patient-based conclusions. Areas covered: This review summarizes recent advances in automated quantitative imaging in cardiology and describes the latest techniques which incorporate machine learning principles. The review focuses on the cardiac imaging techniques which are in wide clinical use. It also discusses key issues and obstacles for these tools to become utilized in mainstream clinical practice. Expert commentary: Fully-automated processing and high-level computer interpretation of cardiac imaging are becoming a reality. Application of machine learning to the vast amounts of quantitative data generated per scan and integration with clinical data also facilitates a move to more patient-specific interpretation. These developments are unlikely to replace interpreting physicians but will provide them with highly accurate tools to detect disease, risk-stratify, and optimize patient-specific treatment. However, with each technological advance, we move further from human dependence and closer to fully-automated machine interpretation.

Non-IgE-related diagnostic methods (LST, patch test).

PubMed

Matsumoto, Kenji

2015-01-01

Although most food allergy patients have immediate-type reactions, some have delayed-type reactions. Unlike for the detection of food-specific IgE antibody in immediate-type (IgE-mediated) food allergies, only a few tests are currently available to aid in the diagnosis of delayed-type (non-IgE-mediated) food allergies. This chapter summarizes our current understanding of one in vitro test and one in vivo test for non-IgE-mediated food allergies: the lymphocyte stimulation test (LST) and the atopy patch test (APT). Although the LST is not yet standardized, a food protein-specific LST might be a useful tool for diagnosing delayed-type food allergies, and especially those manifesting with gastrointestinal symptoms but not skin symptoms. Various remaining issues - including basophil contamination of the peripheral blood mononuclear cell fraction and lipopolysaccharide contamination of food antigen preparations - are also discussed. The APT uses an epicutaneous patch technique to occlusively apply food antigens to the skin to induce inflammatory reactions at the patch application site. Because the APT shows modest sensitivity and specificity, the clinical benefit of the APT in the diagnosis of food allergies in patients with atopic dermatitis is limited. A position paper on the APT issued by the European Academy of Allergy and Clinical Immunology/Global Allergy and Asthma European Network in 2006 is briefly summarized, and several recent APT-related topics, including APT use for the diagnosis of food protein-induced enterocolitis syndrome, are discussed. © 2015 S. Karger AG, Basel.

Current methodological issues in the economic assessment of personalized medicine.

PubMed

Annemans, Lieven; Redekop, Ken; Payne, Katherine

2013-01-01

There is a need for methodological scrutiny in the economic assessment of personalized medicine. In this article, we present a list of 10 specific issues that we argue pose specific methodological challenges that require careful consideration when designing and conducting robust model-based economic evaluations in the context of personalized medicine. Key issues are related to the correct framing of the research question, interpretation of test results, data collection of medical management options after obtaining test results, and expressing the value of tests. The need to formulate the research question clearly and be explicit and specific about the technology being evaluated is essential because various test kits can have the same purpose and yet differ in predictive value, costs, and relevance to practice and patient populations. The correct reporting of sensitivity/specificity, and especially the false negatives and false positives (which are population dependent), of the investigated tests is also considered as a key element. This requires additional structural complexity to establish the relationship between the test result and the consecutive treatment changes and outcomes. This process involves translating the test characteristics into clinical utility, and therefore outlining the clinical and economic consequences of true and false positives and true and false negatives. Information on treatment patterns and on their costs and outcomes, however, is often lacking, especially for false-positive and false-negative test results. The analysis can even become very complex if different tests are combined or sequentially used. This potential complexity can be handled by explicitly showing how these tests are going to be used in practice and then working with the combined sensitivities and specificities of the tests. Each of these issues leads to a higher degree of uncertainty in economic models designed to assess the added value of personalized medicine compared with their simple pharmaceutical counterparts. To some extent, these problems can be overcome by performing early population-level simulations, which can lead to the identification and collection of data on critical input parameters. Finally, it is important to understand that a test strategy does not necessarily lead to more quality-adjusted life-years (QALYs). It is possible that the test will lead to not only fewer QALYs but also fewer costs, which can be defined as "decremental" cost per QALYs. Different decision criteria are needed to interpret such results. © 2013 Published by Elsevier Inc. on behalf of International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

[Drug-facilitated crime and sexual abuse: a pediatric observation].

PubMed

Rey-Salmon, C; Pépin, G

2007-11-01

Drug-facilitated crime in sexual assault situations remains insufficiently recognized by physicians. In the possible context of an assault and in front of recent neuropsychicological disturbances in a child, such an issue has to be considered. The quality of sampling, the use of ultra-sensitive and specific toxicologic methods and a clinical-biological collaboration allow to recognize this form of delinquency whose consequences are both medical and legal.

Concept of biosimilar products in Jordan.

PubMed

Haddadin, Rania Dakhlallah

2011-09-01

After the expiration of patents on originator biological products, Jordanian local manufacturers and the agents of international pharmaceutical companies in Jordan started to submit registration dossiers for biosimilar products. The Jordan Food and Drug Administration (JFDA) is the national regulatory authority responsible for the registration of biosimilar products. Biosimilars are registered under the same regulations used for drugs until specific guidelines for registration of biological and biosimilar products are released. Those regulations are called Criteria of Registration of Drugs, Vaccines, Sera and Biological Products, the Renewal of its Registration and the Cancellation of Any of them which was published in the official gazette in 2004 under the Provisional Law Number 80 of the year 2001, Drug and Pharmacy Law and its amendments of the year 2003. Also, the JFDA follows the EMA guidelines on similar biological medicinal products for specific active biological substances for non-clinical and clinical studies requirements and the EMA guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. A post marketing surveillance study is requested after a biosimilar product is authorized. The JFDA keeps pace with all advances in the regulatory issues related to biosimilars in order to be capable of authorizing biosimilar products with a safe, effective and good quality profile. Copyright © 2011. Published by Elsevier Ltd.

From ecology to base pairs: nursing and genetic science.

PubMed

Williams, J K; Tripp-Reimer, T

2001-07-01

With the mapping of the human genome has come the opportunity for nursing research to explore topics of concern to the maintenance, restoration, and attainment of genetic-related health. Initially, nursing research on genetic topics originated primarily from physical anthropology and from a clinical, disease-focused perspective. Nursing research subsequently focused on psychosocial aspects of genetic conditions for individuals and their family members. As findings emerge from current human genome discovery, new programs of genetic nursing research are originating from a biobehavioral interface, ranging from the investigations of the influence of specific molecular changes on gene function to social/ethical issues of human health and disease. These initiatives reflect nursing's response to discoveries of gene mutations related to phenotypic expression in both clinical and community-based populations. Genetic research programs are needed that integrate or adapt theoretical and methodological advances in epidemiology, family systems, anthropology, and ethics with those from nursing. Research programs must address not only populations with a specific disease but also community-based genetic health care issues. As genetic health care practice evolves, so will opportunities for research by nurses who can apply genetic concepts and interventions to improve the health of the public. This article presents an analysis of the evolution of genetic nursing research and challengesfor the future.

New Functions and Potential Applications of Amino Acids.

PubMed

Uneyama, Hisayuki; Kobayashi, Hisamine; Tonouchi, Naoto

Currently, several types of amino acids are being produced and used worldwide. Nevertheless, several new functions of amino acids have been recently discovered that could result in other applications. For example, oral stimulation by glutamate triggers the cephalic phase response to prepare for food digestion. Further, the stomach and intestines have specific glutamate-recognizing systems in their epithelial mucosa. Regarding clinical applications, addition of monosodium glutamate to the medicinal diet has been shown to markedly enhance gastric secretion in a vagus-dependent manner. Branched-chain amino acids (BCAAs) are the major components of muscles, and ingestion of BCAAs has been found to be effective for decreasing muscle pain. BCAAs are expected to be a solution for the serious issue of aging. Further, ingestion of specific amino acids could be beneficial. Glycine can be ingested for good night's sleep: glycine ingestion before bedtime significantly improved subjective sleep quality. Ingestion of alanine and glutamine effectively accelerates alcohol metabolism, and ingestion of cystine and theanine effectively prevents colds. Finally, amino acids could be used in a novel clinical diagnostic method: the balance of amino acids in the blood could be an indicator of the risk of diseases such as cancer. These newly discovered functions of amino acids are expected to contribute to the resolution of various issues.

Current Issues in Randomized Clinical Trials of Neurodegenerative Disorders at Enrolment and Reporting: Diagnosis, Recruitment, Representativeness of Patients, Ethnicity, and Quality of Reporting.

PubMed

Logroscino, Giancarlo; Capozzo, Rosa; Tortelli, Rosanna; Marin, Benoît

2016-01-01

The investigator is faced with several challenges when planning a randomized clinical trial (RCT). In the early phase, issues are particularly challenging for RCTs in neurodegenerative disorders (NDD). At the time of inclusion in the study, an early and accurate diagnosis is mandatory. Variability of diagnostic criteria, mostly based on clinical grounds, lag time between onset and enrolment, and phenotypic heterogeneity are the main drivers of diagnostic complexity. High-quality data in terms of diagnostic reliability, phenotypic description, follow-up, and evaluation of outcomes are key determinants and are highly conditioned by the expertise of the investigators and center recruitment rate. Representativeness of NDD patients is mandatory to postulate the generalizability of the results of RCTs. There is, however, a systematic selection bias in terms of age (more likely to be younger), sex (more likely to be male), ethnicity (more likely to be of European/Caucasian origin), and other prognostic factors (more likely to be favorable). In the publication phase, researchers need to report properly all of the main features of the RCT. Consolidated Standards of Reporting Trials (CONSORT) facilitates the report and interpretation of RCTs, but adherence to these guidelines needs to be improved. Several issues discussed in this review may alter the internal and external validity of an RCT. To date, the impact on phenotype at study entry has often been overlooked. A differential effect of the selection of subjects and of specific clinical and nonclinical features needs to be systematically explored in the RCT planning phase. © 2016 S. Karger AG, Basel.

Quality in Australian after-hours doctor home visits: exploring the clinical, professional and security supports available to involved practitioners.

PubMed

Ifediora, Chris Onyebuchi

2017-04-01

The after-hours house call (AHHC) services in Australia has gained huge popularity in recent years, but it is not clear how well supported the involved doctors feel regarding the clinical, professional and security aspects of their work. It is important that this knowledge gap is filled given that appropriate support helps engender quality in health service delivery. This is a questionnaire-based electronic survey involving a sample frame of all 300 doctors participating in AHHC through the National Home Doctor Service. National Home Doctor Service is Australia's largest AHHC service provider. A total of 168 valid responses (56.0%) were received. Overall, the mean support levels were mild to moderate, ranging from 2.4 to 2.8 out of 4.0 for all three parameters. Specifically, 65.3% of the respondents felt well-supported on clinical issues, 64.7% on professional issues and 43.2% on security issues. Australian-trained doctors were less likely to feel well supported on all aspects [Clinical: odds ratio (OR) 0.38, confidence interval (CI) 0.16 to 0.90; Professional: OR 0.30, CI 0.13 to 0.72; and Security: OR 0.22; CI 0.09 to 0.53] compared with overseas-trained ones. Unsurprisingly, doctors who adopted protective measures felt significantly better supported regarding security (OR 2.75; CI 1.31 to 5.78). There is room for improvement regarding support on AHHC in Australia, and concerned Surgeries should ensure that where available these supports are appropriately utilized. © 2016 John Wiley & Sons, Ltd.

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.

Competitive Advantage of PET/MRI

PubMed Central

Jadvar, Hossein; Colletti, Patrick M.

2013-01-01

Multimodality imaging has made great strides in the imaging evaluation of patients with a variety of diseases. Positron emission tomography/computed tomography (PET/CT) is now established as the imaging modality of choice in many clinical conditions, particularly in oncology. While the initial development of combined PET/magnetic resonance imaging (PET/MRI) was in the preclinical arena, hybrid PET/MR scanners are now available for clinical use. PET/MRI combines the unique features of MRI including excellent soft tissue contrast, diffusion-weighted imaging, dynamic contrast-enhanced imaging, fMRI and other specialized sequences as well as MR spectroscopy with the quantitative physiologic information that is provided by PET. Most evidence for the potential clinical utility of PET/MRI is based on studies performed with side-by-side comparison or software-fused MRI and PET images. Data on distinctive utility of hybrid PET/MRI are rapidly emerging. There are potential competitive advantages of PET/MRI over PET/CT. In general, PET/MRI may be preferred over PET/CT where the unique features of MRI provide more robust imaging evaluation in certain clinical settings. The exact role and potential utility of simultaneous data acquisition in specific research and clinical settings will need to be defined. It may be that simultaneous PET/MRI will be best suited for clinical situations that are disease-specific, organ-specific, related to diseases of the children or in those patients undergoing repeated imaging for whom cumulative radiation dose must be kept as low as reasonably achievable. PET/MRI also offers interesting opportunities for use of dual modality probes. Upon clear definition of clinical utility, other important and practical issues related to business operational model, clinical workflow and reimbursement will also be resolved. PMID:23791129

Competitive advantage of PET/MRI.

PubMed

Jadvar, Hossein; Colletti, Patrick M

2014-01-01

Multimodality imaging has made great strides in the imaging evaluation of patients with a variety of diseases. Positron emission tomography/computed tomography (PET/CT) is now established as the imaging modality of choice in many clinical conditions, particularly in oncology. While the initial development of combined PET/magnetic resonance imaging (PET/MRI) was in the preclinical arena, hybrid PET/MR scanners are now available for clinical use. PET/MRI combines the unique features of MRI including excellent soft tissue contrast, diffusion-weighted imaging, dynamic contrast-enhanced imaging, fMRI and other specialized sequences as well as MR spectroscopy with the quantitative physiologic information that is provided by PET. Most evidence for the potential clinical utility of PET/MRI is based on studies performed with side-by-side comparison or software-fused MRI and PET images. Data on distinctive utility of hybrid PET/MRI are rapidly emerging. There are potential competitive advantages of PET/MRI over PET/CT. In general, PET/MRI may be preferred over PET/CT where the unique features of MRI provide more robust imaging evaluation in certain clinical settings. The exact role and potential utility of simultaneous data acquisition in specific research and clinical settings will need to be defined. It may be that simultaneous PET/MRI will be best suited for clinical situations that are disease-specific, organ-specific, related to diseases of the children or in those patients undergoing repeated imaging for whom cumulative radiation dose must be kept as low as reasonably achievable. PET/MRI also offers interesting opportunities for use of dual modality probes. Upon clear definition of clinical utility, other important and practical issues related to business operational model, clinical workflow and reimbursement will also be resolved. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Synergies and Distinctions between Computational Disciplines in Biomedical Research: Perspective from the Clinical and Translational Science Award Programs

PubMed Central

Bernstam, Elmer V.; Hersh, William R.; Johnson, Stephen B.; Chute, Christopher G.; Nguyen, Hien; Sim, Ida; Nahm, Meredith; Weiner, Mark; Miller, Perry; DiLaura, Robert P.; Overcash, Marc; Lehmann, Harold P.; Eichmann, David; Athey, Brian D.; Scheuermann, Richard H.; Anderson, Nick; Starren, Justin B.; Harris, Paul A.; Smith, Jack W.; Barbour, Ed; Silverstein, Jonathan C.; Krusch, David A.; Nagarajan, Rakesh; Becich, Michael J.

2010-01-01

Clinical and translational research increasingly requires computation. Projects may involve multiple computationally-oriented groups including information technology (IT) professionals, computer scientists and biomedical informaticians. However, many biomedical researchers are not aware of the distinctions among these complementary groups, leading to confusion, delays and sub-optimal results. Although written from the perspective of clinical and translational science award (CTSA) programs within academic medical centers, the paper addresses issues that extend beyond clinical and translational research. The authors describe the complementary but distinct roles of operational IT, research IT, computer science and biomedical informatics using a clinical data warehouse as a running example. In general, IT professionals focus on technology. The authors distinguish between two types of IT groups within academic medical centers: central or administrative IT (supporting the administrative computing needs of large organizations) and research IT (supporting the computing needs of researchers). Computer scientists focus on general issues of computation such as designing faster computers or more efficient algorithms, rather than specific applications. In contrast, informaticians are concerned with data, information and knowledge. Biomedical informaticians draw on a variety of tools, including but not limited to computers, to solve information problems in health care and biomedicine. The paper concludes with recommendations regarding administrative structures that can help to maximize the benefit of computation to biomedical research within academic health centers. PMID:19550198

Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop.

PubMed

Coffey, Christopher S; Levin, Bruce; Clark, Christina; Timmerman, Cate; Wittes, Janet; Gilbert, Peter; Harris, Sara

2012-12-01

The clinical trials community has a never-ending search for dependable and reliable ways to improve clinical research. This exploration has led to considerable interest in adaptive clinical trial designs, which provide the flexibility to adjust trial characteristics on the basis of data reviewed at interim stages. Statisticians and clinical investigators have proposed or implemented a wide variety of adaptations in clinical trials, but specific approaches have met with differing levels of support. Within industry, investigators are actively exploring the benefits and pitfalls associated with adaptive designs (ADs). For example, a Drug Information Association (DIA) working group on ADs has engaged regulatory agencies in discussions. Many researchers working on publicly funded clinical trials, however, are not yet fully engaged in this discussion. We organized the Scientific Advances in Adaptive Clinical Trial Designs Workshop to begin a conversation about using ADs in publicly funded research. Held in November of 2009, the 1½-day workshop brought together representatives from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the pharmaceutical industry, nonprofit foundations, the patient advocacy community, and academia. The workshop offered a forum for participants to address issues of ADs that arise at the planning, designing, and execution stages of clinical trials, and to hear the perspectives of influential members of the clinical trials community. The participants also set forth recommendations for guiding action to promote the appropriate use of ADs. These recommendations have since been presented, discussed, and vetted in a number of venues including the University of Pennsylvania Conference on Statistical Issues in Clinical Trials and the Society for Clinical Trials annual meeting. To provide a brief overview of ADs, describe the rationale behind conducting the workshop, and summarize the main recommendations that were produced as a result of this workshop. There is a growing interest in the use of adaptive clinical trial designs. However, a number of logistical barriers need to be addressed in order to obtain the potential advantages of an AD. Currently, the pharmaceutical industry is well ahead of academic trialists with respect to addressing these barriers. Academic trialists will need to address important issues such as education, infrastructure, modifications to existing funding models, and the impact on Data and Safety Monitoring Boards (DSMB) in order to achieve the possible benefits of adaptive clinical trial designs.

WE-F-201-03: Evaluate Clinical Cases Using Commercially Available Systems and Compare to TG-43 Dosimetry

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beaulieu, L.

With the recent introduction of heterogeneity correction algorithms for brachytherapy, the AAPM community is still unclear on how to commission and implement these into clinical practice. The recently-published AAPM TG-186 report discusses important issues for clinical implementation of these algorithms. A charge of the AAPM-ESTRO-ABG Working Group on MBDCA in Brachytherapy (WGMBDCA) is the development of a set of well-defined test case plans, available as references in the software commissioning process to be performed by clinical end-users. In this practical medical physics course, specific examples on how to perform the commissioning process are presented, as well as descriptions of themore » clinical impact from recent literature reporting comparisons of TG-43 and heterogeneity-based dosimetry. Learning Objectives: Identify key clinical applications needing advanced dose calculation in brachytherapy. Review TG-186 and WGMBDCA guidelines, commission process, and dosimetry benchmarks. Evaluate clinical cases using commercially available systems and compare to TG-43 dosimetry.« less

[Legal repercussions of Clinical Ethics Committees reports].

PubMed

Couceiro V, Azucena; Beca I, Juan Pablo

2006-04-01

Clinical Ethics Committees and Research Ethics Committees have their own specific roles. The Clinical Ethics Committee's pronouncements have an advisory function, whereas Research Ethics Committees' decisions are binding. This article analyzes the legal impact of the Clinical Ethics Committees' reports. Legal and medical reasoning share the same practical nature. Both can have several correct answers to the same situation. Clinical Ethics Committees deliberate about these alternatives and analyze the involved values. Their conclusions are non-compulsory recommendations. They do not replace nor diminish the doctor's personal responsibility. Even though the Clinical Ethics Committees' reports are not binding, they constitute a sort of "expert's opinion", expressed by qualified professionals, who assume their own professional responsibility as advisors. The members' behavior is necessarily subject to constitutional and legal regulations. When judges review the Clinical Ethics Committee's reports, they must realize that their nature is advisory, and also consider them an essential element to reduce the gap between the medical and legal fields. In this way, the problem of increasingly transforming medicine into a legal issue can be prevented.

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project.

PubMed

Merle, Corinne S C; Sismanidis, Charalambos; Sow, Oumou Bah; Gninafon, Martin; Horton, John; Lapujade, Olivier; Lo, Mame Bocar; Mitchinson, Denis A; Perronne, Christian; Portaels, Francoise; Odhiambo, Joseph; Olliaro, Piero; Rustomjee, Roxana; Lienhardt, Christian; Fielding, Katherine

2012-05-18

There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish between relapse and re-infection.

A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

PubMed Central

2012-01-01

Background There have been no major advances in tuberculosis (TB) drug development since the first East African/British Medical Research Council short course chemotherapy trial 35 years ago. Since then, the landscape for conducting TB clinical trials has profoundly changed with the emergence of HIV infection, the spread of resistant TB bacilli strains, recent advances in mycobacteriological capacity, and drug discovery. As a consequence questions have arisen on the most appropriate approach to design and conduct current TB trials. To highlight key issues discussed: Is a superiority, equivalence, or non-inferiority design most appropriate? What should be the primary efficacy outcome? How to consider re-infections in the definition of the outcome? What is the optimal length of patient follow-up? Is blinding appropriate when treatment duration in test arm is shorter? What are the appropriate assumptions for sample size calculation? Methods Various drugs are currently in the development pipeline. We are presenting in this paper the design of the most recently completed phase III TB trial, the OFLOTUB project, which is the pivotal trial of a registration portfolio for a gatifloxacin-containing TB regimen. It is a randomized, open-label, multicenter, controlled trial aiming to evaluate the efficacy and safety of a gatifloxacin-containing 4-month regimen (trial registration: ClinicalTrial.gov database: NCT00216385). Results In the light of the recent scientific and regulatory discussions, we discuss some of the design issues in TB clinical trials and more specifically the reasons that guided our choices, in order to best answer the trial objectives, while at the same time satisfying regulatory authority requirements. Conclusion When shortening TB treatment, we are advocating for a non-inferiority, non-blinded design, with a composite unfavorable endpoint assessed 12 months post treatment completion, and added trial procedures specifically aiming to: (1) minimize endpoint unavailability; and (2) distinguish between relapse and re-infection. PMID:22607233

Accessing and integrating data and knowledge for biomedical research.

PubMed

Burgun, A; Bodenreider, O

2008-01-01

To review the issues that have arisen with the advent of translational research in terms of integration of data and knowledge, and survey current efforts to address these issues. Using examples form the biomedical literature, we identified new trends in biomedical research and their impact on bioinformatics. We analyzed the requirements for effective knowledge repositories and studied issues in the integration of biomedical knowledge. New diagnostic and therapeutic approaches based on gene expression patterns have brought about new issues in the statistical analysis of data, and new workflows are needed are needed to support translational research. Interoperable data repositories based on standard annotations, infrastructures and services are needed to support the pooling and meta-analysis of data, as well as their comparison to earlier experiments. High-quality, integrated ontologies and knowledge bases serve as a source of prior knowledge used in combination with traditional data mining techniques and contribute to the development of more effective data analysis strategies. As biomedical research evolves from traditional clinical and biological investigations towards omics sciences and translational research, specific needs have emerged, including integrating data collected in research studies with patient clinical data, linking omics knowledge with medical knowledge, modeling the molecular basis of diseases, and developing tools that support in-depth analysis of research data. As such, translational research illustrates the need to bridge the gap between bioinformatics and medical informatics, and opens new avenues for biomedical informatics research.

From gender bias to gender awareness in medical education.

PubMed

Verdonk, Petra; Benschop, Yvonne W M; de Haes, Hanneke C J M; Lagro-Janssen, Toine L M

2009-03-01

Gender is an essential determinant of health and illness. Gender awareness in doctors contributes to equity and equality in health and aims towards better health for men and women. Nevertheless, gender has largely been ignored in medicine. First, it is stated that medicine was 'gender blind' by not considering gender whenever relevant. Secondly, medicine is said to be 'male biased' because the largest body of knowledge on health and illness is about men and their health. Thirdly, gender role ideology negatively influences treatment and health outcomes. Finally, gender inequality has been overlooked as a determinant of health and illness. The uptake of gender issues in medical education brings about specific challenges for several reasons. For instance, the political-ideological connotations of gender issues create resistance especially in traditionalists in medical schools. Secondly, it is necessary to clarify which gender issues must be integrated in which domains. Also, some are interdisciplinary issues and as such more difficult to integrate. Finally, schools need assistance with implementation. The integration of psychosocial issues along with biomedical ones in clinical cases, the dissemination of literature and education material, staff education, and efforts towards structural embedding of gender in curricula are determining factors for successful implementation. Gender equity is not a spontaneous process. Medical education provides specific opportunities that may contribute to transformation for medical schools educate future doctors for future patients in future settings. Consequently, future benefits legitimize the integration of gender as a qualitative investment in medical education.

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.

Website design: technical, social and medical issues for self-reporting by elderly patients.

PubMed

Taylor, Mark J; Stables, Rod; Matata, Bashir; Lisboa, Paulo J G; Laws, Andy; Almond, Peter

2014-06-01

There is growing interest in the use of the Internet for interacting with patients, both in terms of healthcare information provision and information gathering. In this article, we examine the issues in designing healthcare websites for elderly users. In particular, this article uses a year-long case study of the development of a web-based system for self-reporting of symptoms and quality of life with a view to examine the issues relating to website design for elderly users. The issues identified included the technical, social and medical aspects of website design for elderly users. The web-based system developed was based on the European Quality of Life 5-Dimensions health-status questionnaire, a commonly used tool for patient self-reporting of quality of life, and the more specific coronary revascularisation outcome questionnaire. Currently, self-reporting is generally administered in the form of paper-based questionnaires to be completed in the outpatient clinic or at home. There are a variety of issues relating to elderly users, which imply that websites for elderly patients may involve different design considerations to other types of websites.

Meeting the challenges of clinical information provision.

PubMed

Spring, Hannah

2017-12-01

This virtual issue of the Health Information and Libraries Journal (HILJ) has been compiled to mark the 5th International Clinical Librarian Conference 2011. In considering the challenges of clinical information provision, the content selected for the virtual issue offers an international flavour of clinical information provision and covers a variety of different facets of clinical librarianship. The issue broadly covers the areas of information needs and preferences, clinical librarian roles and services, and education and training, and reflects the way in which a normal issue of the HILJ would be presented. This includes a review article, a collection of original articles, and the three regular features which comprise International Perspectives and Initiatives, Learning and Teaching in Action, and Using Evidence in Practice. All papers included in this virtual issue are available free online. © 2011 The authors. Health Information and Libraries Journal © 2011 Health Libraries Group.

Understanding what matters most to people with multiple myeloma: a qualitative study of views on quality of life

PubMed Central

2014-01-01

Background Multiple myeloma is an incurable haematological cancer that affects physical, psychological and social domains of quality of life (QOL). Treatment decisions are increasingly guided by QOL issues, creating a need to monitor QOL within clinical practice. The development of myeloma-specific QOL questionnaires has been limited by a paucity of research to fully characterise QOL in this group. Aims of the present study are to (1) explore the issues important to QOL from the perspective of people with multiple myeloma, and (2) explore the views of patients and clinical staff on existing QOL questionnaires and their use in clinical practice. Methods The ‘Issues Interviews’ were semi-structured qualitative interviews to explore the issues important to QOL in a purposive sample of myeloma patients (n = 20). The ‘Questionnaire Interviews’ were semi-structured qualitative interviews in a separate purposive sample of myeloma patients (n = 20) to explore views on existing QOL questionnaires and their clinical use. Two patient focus groups (n = 7, n = 4) and a focus group of clinical staff (n = 6) complemented the semi-structured interviews. Thematic content analysis resulted in the development of a theoretical model of QOL in myeloma. Results Main themes important to QOL were Biological Status, Treatment Factors, Symptoms Status, Activity & Participation, Emotional Status, Support Factors, Expectations, Adaptation & Coping and Spirituality. Symptoms had an indirect effect on QOL, only affecting overall QOL if they impacted upon Activity & Participation, Emotional Status or Support Factors. This indirect relationship has implications for the design of QOL questionnaires, which often focus on symptom status. Health-service factors emerged as important but are often absent from QOL questionnaires. Sexual function was important to patients and difficult for clinicians to discuss, so inclusion in clinical QOL tools may flag hidden problems and facilitate better care. Patients and staff expressed preferences for questionnaires to be no more than 2 pages long and to include a mixture of structured and open questions to focus the goals of care on what is most important to patients. Conclusion Existing QOL questionnaires developed and validated for use in myeloma do not capture all that is important to patients and may not be well suited to clinical use. PMID:25005145

Implementation of psychological clinical trials in epilepsy: Review and guide.

PubMed

Modi, Avani C; Wagner, Janelle; Smith, Aimee W; Kellermann, Tanja S; Michaelis, Rosa

2017-09-01

The International League Against Epilepsy (ILAE) Neuropsychiatry commission and United States Institute of Medicine report both identified cognitive and psychological comorbidities as a significant issue for individuals with epilepsy, with rates as high as 60%. However, there is a paucity of evidence-based treatments for many psychological conditions (e.g., learning disorders, cognitive disorders, behavioral disorders). Because of inherent challenges in the implementation of psychological therapy trials and specific considerations for the population with epilepsy, the focus of the current review was to provide guidance and recommendations to conduct psychological trials for individuals with epilepsy. Several key areas will be discussed, including selection of patients, trial design, psychological intervention considerations, outcomes and evaluation of results, publication of trial results, and special issues related to pediatric clinical trials. Rigorously designed psychological therapy trials will set the stage for evidence-based practice in the care of individuals with epilepsy, with the goal of improving seizures, side effects, and HRQOL. Copyright © 2017 Elsevier Inc. All rights reserved.

Paediatric stroke: pressing issues and promising directions.

PubMed

Kirton, Adam; deVeber, Gabrielle

2015-01-01

Stroke occurs across the lifespan with unique issues in the fetus, neonate, and child. The past decade has seen substantial advances in paediatric stroke research and clinical care, but many unanswered questions and controversies remain. The pathobiology of perinatal stroke needs to be better understood if prevention strategies are to be realised. Similarly, enhanced understanding of the mechanisms underlying childhood stroke, including cerebral arteriopathies, could inform the development of mechanism-specific treatments. Emerging clinical trials, including studies of neonatal sinovenous thrombosis and childhood arterial stroke, offer the hope of evidence-based treatment options in the near future. Early recognition of stroke in children is a key educational target for both the public and health-care professionals, and has translational potential to advance the application of neuroprotective, thrombolytic, and antithrombotic interventions and rehabilitation strategies to the earliest possible timepoints after stroke onset, improving outcomes and quality of life for affected children and their families. Copyright © 2015 Elsevier Ltd. All rights reserved.

Ethical and social issues in presymptomatic testing for Huntington's disease: a European Community collaborative study. European Community Huntington's Disease Collaborative Study Group.

PubMed Central

1993-01-01

An analysis of social and ethical aspects of presymptomatic testing for Huntington's disease has been carried out, based on data on linked DNA markers, from four major testing centres in different European Community countries (Belgium, Italy, Netherlands, and United Kingdom). Information was available on 603 applicants, with 213 final results given, of which 32% gave an increased risk. A series of specific issues and problems were documented systematically for all applicants, results being given on frequency of occurrence and illustrated by individual case histories. The principal issues could be grouped as problems of inappropriate referral, problems involving relatives, and problems relating to disclosure of results. At least one important problem was encountered in 46% of applicants, emphasising the importance of expert counselling, preparation, and support of applicants, and of close liaison between clinical, counselling, and laboratory staff. The extensive and detailed information available for Huntington's disease from this and other studies will be of considerable value in relation to genetic testing for other late onset genetic disorders and will be even more relevant to Huntington's disease now that specific mutation analysis is possible for this disorder. PMID:8133502

Relationship between total quality management, critical paths, and outcomes management.

PubMed

Lynn, P A

1996-09-01

Total quality management (TQM), clinical paths, and outcomes management are high-profile strategies in today's health care environment. Each strategy is distinct, yet there are interrelationships among them. TQM supports a customer-focused organizational culture, providing tools and techniques to identify and solve problems. Clinical paths are tools for enhancing patient care coordination and for identifying system-wide and patient population specific issues. Outcomes management is an integrated system for measuring the results in patient populations over time. There is a recent shift in outcomes measurement towards expanding both the nature of the outcomes examined and the timeframes in which they are studied.

The use of nanoparticulates to treat breast cancer.

PubMed

Tang, Xiaomeng; Loc, Welley S; Dong, Cheng; Matters, Gail L; Butler, Peter J; Kester, Mark; Meyers, Craig; Jiang, Yixing; Adair, James H

2017-10-01

Breast cancer is a major ongoing public health issue among women in both developing and developed countries. Significant progress has been made to improve the breast cancer treatment in the past decades. However, the current clinical approaches are invasive, of low specificity and can generate severe side effects. As a rapidly developing field, nanotechnology brings promising opportunities to human cancer diagnosis and treatment. The use of nanoparticulate-based platforms overcomes biological barriers and allows prolonged blood circulation time, simultaneous tumor targeting and enhanced accumulation of drugs in tumors. Currently available and clinically applicable innovative nanoparticulate-based systems for breast cancer nanotherapies are discussed in this review.

Liver transplant for cholestatic liver diseases.

PubMed

Carrion, Andres F; Bhamidimarri, Kalyan Ram

2013-05-01

Cholestatic liver diseases include a group of diverse disorders with different epidemiology, pathophysiology, clinical course, and prognosis. Despite significant advances in the clinical care of patients with cholestatic liver diseases, liver transplant (LT) remains the only definitive therapy for end-stage liver disease, regardless of the underlying cause. As per the United Network for Organ Sharing database, the rate of cadaveric LT for cholestatic liver disease was 18% in 1991, 10% in 2000, and 7.8% in 2008. This review summarizes the available evidence on various common and rare cholestatic liver diseases, disease-specific issues, and pertinent aspects of LT. Copyright © 2013 Elsevier Inc. All rights reserved.

Highlights from the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, USA, 12–15 May 2001

PubMed Central

Lohrisch, Caroline

2001-01-01

Key issues discussed at the breast cancer sessions of the 37th American Society of Clinical Oncology (ASCO) meeting, 2001, included the following: breast cancer in the elderly; toxicity; updates on HER2 and use of trastuzumab (anti-HER2) in metastatic disease; and several early reports on novel therapeutic strategies. As was stated by numerous speakers both at this and other meetings, and as demonstrated by several abstracts, the use of predictive factors appears to be the most effective way to enhance the efficacy of numerous therapies, both target specific and nonspecific.

Fundamentals of Pharmacogenetics in Personalized, Precision Medicine.

PubMed

Valdes, Roland; Yin, DeLu Tyler

2016-09-01

This article introduces fundamental principles of pharmacogenetics as applied to personalized and precision medicine. Pharmacogenetics establishes relationships between pharmacology and genetics by connecting phenotypes and genotypes in predicting the response of therapeutics in individual patients. We describe differences between precision and personalized medicine and relate principles of pharmacokinetics and pharmacodynamics to applications in laboratory medicine. We also review basic principles of pharmacogenetics, including its evolution, how it enables the practice of personalized therapeutics, and the role of the clinical laboratory. These fundamentals are a segue for understanding specific clinical applications of pharmacogenetics described in subsequent articles in this issue. Copyright © 2016 Elsevier Inc. All rights reserved.

SU-E-P-02: Imaging and Radiation Oncology Core (IROC) Houston QA Center (RPC) Credentialing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Amador, C; Keith, T; Nguyen, T

2014-06-01

Purpose: To provide information pertaining to IROC Houston QA Center's (RPC) credentialing process for institutions participating in NCI-sponsored clinical trials. Methods: IROC Houston issues credentials for NCI sponsored study groups. Requirements for credentialing might include any combination of questionnaires, knowledge assessment forms, benchmarks, or phantom irradiations. Credentialing requirements for specific protocols can be found on IROC Houston's website (irochouston.mdanderson.org). The website also houses the credentialing status inquiry (CSI) form. Once an institution has reviewed the protocol's credentialing requirements, a CSI form should be completed and submitted to IROC Houston. This form is used both to request whether requirements have beenmore » met as well as to notify IROC Houston that the institution requests credentialing for a specific protocol. IROC Houston will contact the institution to discuss any delinquent requirements. Once the institution has met all requirements IROC Houston issues a credentialing letter to the institution and will inform study groups and other IROC offices of the credentials. Institutions can all phone the IROC Houston office to initiate credentialing or ask any credentialing related questions. Results: Since 2010 IROC has received 1313 credentialing status inquiry forms. We received 317 in 2010, 266 in 2011, 324 in 2012, and 406 in 2013. On average we receive 35 phone calls per week with multiple types of credentialing questions. Decisions regarding credentialing status are based on the protocol specifications and previous completed credentialing by the institution. In some cases, such as for general IMRT credentialing, up to 5 sites may be credentialed based on the credentialing of one main center. Each of these situations is handled individually. Conclusion: IROC Houston will issue radiation therapy credentials for the NCI trials in the National Clinical Trials Network. Credentialing requirements and the CSI form can be found online at the IROC Houston's website. Work supported by PHS grant CA10953 and CA081647 (NCI, DHHS)« less

Methodological issues with adaptation of clinical trial design.

PubMed

Hung, H M James; Wang, Sue-Jane; O'Neill, Robert T

2006-01-01

Adaptation of clinical trial design generates many issues that have not been resolved for practical applications, though statistical methodology has advanced greatly. This paper focuses on some methodological issues. In one type of adaptation such as sample size re-estimation, only the postulated value of a parameter for planning the trial size may be altered. In another type, the originally intended hypothesis for testing may be modified using the internal data accumulated at an interim time of the trial, such as changing the primary endpoint and dropping a treatment arm. For sample size re-estimation, we make a contrast between an adaptive test weighting the two-stage test statistics with the statistical information given by the original design and the original sample mean test with a properly corrected critical value. We point out the difficulty in planning a confirmatory trial based on the crude information generated by exploratory trials. In regards to selecting a primary endpoint, we argue that the selection process that allows switching from one endpoint to the other with the internal data of the trial is not very likely to gain a power advantage over the simple process of selecting one from the two endpoints by testing them with an equal split of alpha (Bonferroni adjustment). For dropping a treatment arm, distributing the remaining sample size of the discontinued arm to other treatment arms can substantially improve the statistical power of identifying a superior treatment arm in the design. A common difficult methodological issue is that of how to select an adaptation rule in the trial planning stage. Pre-specification of the adaptation rule is important for the practicality consideration. Changing the originally intended hypothesis for testing with the internal data generates great concerns to clinical trial researchers.

Factors impacting on psychological wellbeing of international students in the health professions: A scoping review.

PubMed

McKenna, Lisa; Robinson, Eddie; Penman, Joy; Hills, Danny

2017-09-01

There are increasing numbers of international students undertaking health professional courses, particularly in Western countries. These courses not only expose students to the usual stresses and strains of academic learning, but also require students to undertake clinical placements and practice-based learning. While much is known about general issues facing international students, less is known about factors that impact on those studying in the health professions. To explore what is known about factors that influence the psychological wellbeing of international students in the health professions. A scoping review. A range of databases were searched, including CINAHL, Medline, Scopus, Proquest and ERIC, as well as grey literature, reference lists and Google Scholar. The review included qualitative or quantitative primary peer reviewed research studies that focused on international undergraduate or postgraduate students in the health professions. The core concept underpinning the review was psychological issues, with the outcome being psychological and/or social wellbeing. Thematic analysis across studies was used to identify key themes emerging. A total of 13 studies were included in the review, from the disciplines of nursing, medicine and speech-language pathology. Four key factor groups emerged from the review: negotiating structures and systems, communication and learning, quality of life and self-care, and facing discrimination and social isolation. International health professional students face similar issues to other international students. The nature of their courses, however, also requires negotiating different health care systems, and managing a range of clinical practice issues including with communication, and isolation and discrimination from clinical staff and patients. Further research is needed to specifically explore factors impacting on student well-being and how international students can be appropriately prepared and supported for their encounters. Copyright © 2017 Elsevier Ltd. All rights reserved.

Research Domain Criteria as Psychiatric Nosology.

PubMed

Akram, Faisal; Giordano, James

2017-10-01

Diagnostic classification systems in psychiatry have continued to rely on clinical phenomenology, despite limitations inherent in that approach. In view of these limitations and recent progress in neuroscience, the National Institute of Mental Health (NIMH) has initiated the Research Domain Criteria (RDoC) project to develop a more neuroscientifically based system of characterizing and classifying psychiatric disorders. The RDoC initiative aims to transform psychiatry into an integrative science of psychopathology in which mental illnesses will be defined as involving putative dysfunctions in neural nodes and networks. However, conceptual, methodological, neuroethical, and social issues inherent in and/or derived from the use of RDoC need to be addressed before any attempt is made to implement their use in clinical psychiatry. This article describes current progress in RDoC; defines key technical, neuroethical, and social issues generated by RDoC adoption and use; and posits key questions that must be addressed and resolved if RDoC are to be employed for psychiatric diagnoses and therapeutics. Specifically, we posit that objectivization of complex mental phenomena may raise ethical questions about autonomy, the value of subjective experience, what constitutes normality, what constitutes a disorder, and what represents a treatment, enablement, and/or enhancement. Ethical issues may also arise from the (mis)use of biomarkers and phenotypes in predicting and treating mental disorders, and what such definitions, predictions, and interventions portend for concepts and views of sickness, criminality, professional competency, and social functioning. Given these issues, we offer that a preparatory neuroethical framework is required to define and guide the ways in which RDoC-oriented research can-and arguably should-be utilized in clinical psychiatry, and perhaps more broadly, in the social sphere.

A Mobile and Intelligent Patient Diary for Chronic Disease Self-Management.

PubMed

Van Woensel, William; Roy, Patrice C; Abidi, Samina R; Abidi, Syed S R

2015-01-01

By involving patients in their own long-term care, patient self-management approaches aim to increase self-sufficiency and reduce healthcare costs. For example, electronic patient diaries enable patients to collect health data autonomously, increasing self-reliance and reducing strain on health professionals. By deploying patient diaries on mobile platforms, health data collection can occur at any time and place, increasing the mobility of chronic patients who typically need to enter health data frequently. Importantly, an opportunity also arises for mobile clinical decision support, where health feedback is directly issued to patients without relying on connectivity or remote servers. Regardless of the specific self-management strategy, patient and healthcare provider adoption are crucial. Tailoring the system towards the particular patient and toward institution-specific clinical pathways is essential to increasing acceptance. In this paper we discuss a mobile patient diary realizing both the opportunities and challenges of mobile deployment.

Recent advances in therapeutic recruitment of mammalian RNAi and bacterial CRISPR-Cas DNA interference pathways as emerging antiviral strategies.

PubMed

Chin, Wei-Xin; Ang, Swee Kim; Chu, Justin Jang Hann

2017-01-01

In invertebrate eukaryotes and prokaryotes, respectively, the RNAi and clustered regularly interspaced short palindromic repeats-CRISPR-associated (CRISPR-Cas) pathways are highly specific and efficient RNA and DNA interference systems, and are well characterised as potent antiviral systems. It has become possible to recruit or reconstitute these pathways in mammalian cells, where they can be directed against desired host or viral targets. The RNAi and CRISPR-Cas systems can therefore yield ideal antiviral therapeutics, capable of specific and efficient viral inhibition with minimal off-target effects, but development of such therapeutics can be slow. This review covers recent advances made towards developing RNAi or CRISPR-Cas strategies for clinical use. These studies address the delivery, toxicity or target design issues that typically plague the in vivo or clinical use of these technologies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pitfalls in the psychoeducational assessment of adolescents with learning and school adjustment problems.

PubMed

Pollak, J M

1985-01-01

Over the past decade there has been a growing interest on the part of educators, medical specialists, mental health personnel, and the lay public in the diagnosis, evaluation, and remediation of specific learning disabilities in the school-age child. This paper attempts to show through case illustrations of five high school-age adolescents how parents can seek from clinical evaluators a diagnostic impression of primary learning disability for their nonlearning disabled children; how this otherwise legitimate diagnostic category can be inappropriately used in the service of denying the salient individual, emotional, and family system factors at work in the school-related difficulties; and how the label of learning disability can work as a formidable resistance on the part of the family when, following comprehensive, in-depth assessment, professional recommendations focus less on specific educational remediation and more on the need for individual or family psychotherapy. Suggestions are made for dealing with this clinical issue.

Health Disparities in Women

PubMed Central

Hornbuckle, Lyndsey M; Amutah-Onukagha, Ndidiamaka; Bryan, Alicia; Skidmore Edwards, Elizabeth; Madzima, Takudzwa; Massey, Kelly; May, Linda; Robinson, Leah E

2017-01-01

AIMS AND SCOPE Clinical Medicine Insights: Women’s Health is an international, open-access, peer-reviewed journal which considers manuscripts on all aspects of the diagnosis, management, and prevention of disorders specific to women, in addition to related genetic, pathophysiological, and epidemiological topics. Clinical Medicine Insights: Women’s Health aims to provide researchers working in this complex, quickly developing field with online, open access to highly relevant scholarly articles by leading international researchers. In a field where the literature is ever-expanding, researchers increasingly need access to up-to-date, high-quality scholarly articles on areas of specific contemporary interest. This supplement is on Health Disparities in Women. This supplement aims to address this by presenting high-quality articles that allow readers to distinguish the signal from the noise. The editor in chief hopes that through this effort, practitioners and researchers will be aided in finding answers to some of the most complex and pressing issues of our time. PMID:28579867

Characterizing a psychiatric symptom dimension related to deficits in goal-directed control.

PubMed

Gillan, Claire M; Kosinski, Michal; Whelan, Robert; Phelps, Elizabeth A; Daw, Nathaniel D

2016-03-01

Prominent theories suggest that compulsive behaviors, characteristic of obsessive-compulsive disorder and addiction, are driven by shared deficits in goal-directed control, which confers vulnerability for developing rigid habits. However, recent studies have shown that deficient goal-directed control accompanies several disorders, including those without an obvious compulsive element. Reasoning that this lack of clinical specificity might reflect broader issues with psychiatric diagnostic categories, we investigated whether a dimensional approach would better delineate the clinical manifestations of goal-directed deficits. Using large-scale online assessment of psychiatric symptoms and neurocognitive performance in two independent general-population samples, we found that deficits in goal-directed control were most strongly associated with a symptom dimension comprising compulsive behavior and intrusive thought. This association was highly specific when compared to other non-compulsive aspects of psychopathology. These data showcase a powerful new methodology and highlight the potential of a dimensional, biologically-grounded approach to psychiatry research.

The Emerging Role of Meditation in Addressing Psychiatric Illness, with a Focus on Substance Use Disorders

PubMed Central

Dakwar, Elias; Levin, Frances R.

2011-01-01

Over the past 30 years the practice of meditation has become increasingly popular in clinical settings. In addition to evidence-based medical uses, meditation may have psychiatric benefits. In this review, the literature on the role of meditation in addressing psychiatric issues, and specifically substance use disorders, is discussed. Each of the three meditation modalities that have been most widely studied—transcendental meditation, Buddhist meditation, and mindfulness-based meditation—is critically examined in terms of its background, techniques, mechanisms of action, and evidence-based clinical applications, with special attention given to its emerging role in the treatment of substance use disorders. The unique methodological difficulties that beset the study of meditation are also considered. A brief discussion then integrates the research that has been completed thus far, elucidates the specific ways that meditation may be helpful for substance use disorders, and suggests new avenues for research. PMID:19637074

Clinical indications for antibiotic use in Danish general practice: results from a nationwide electronic prescription database

PubMed Central

Aabenhus, Rune; Hansen, Malene Plejdrup; Siersma, Volkert; Bjerrum, Lars

2017-01-01

Objective To assess the availability and applicability of clinical indications from electronic prescriptions on antibiotic use in Danish general practice. Design Retrospective cohort register-based study including the Danish National Prescription Register. Setting Population-based study of routine electronic antibiotic prescriptions from Danish general practice. Subjects All 975,626 patients who redeemed an antibiotic prescription at outpatient pharmacies during the 1-year study period (July 2012 to June 2013). Main outcome measures Number of prescriptions per clinical indication. Number of antibiotic prescriptions per 1000 inhabitants by age and gender. Logistic regression analysis estimated the association between patient and provider factors and missing clinical indications on antibiotic prescriptions. Results A total of 2.381.083 systemic antibiotic prescriptions were issued by Danish general practitioners in the study period. We identified three main clinical entities: urinary tract infections (n = 506.634), respiratory tract infections (n = 456.354) and unspecified infections (n = 416.354). Women were more exposed to antibiotics than men. Antibiotic use was high in children under 5 years and even higher in elderly people. In 32% of the issued prescriptions, the clinical indication was missing. This was mainly associated with antibiotic types. We found that a prescription for a urinary tract agent without a specific clinical indication was uncommon. Conclusion Clinical indications from electronic prescriptions are accessible and available to provide an overview of drug use, in casu antibiotic prescriptions, in Danish general practice. These clinical indications may be further explored in detail to assess rational drug use and congruence with guidelines, but validation and optimisation of the system is preferable. PMID:28585886

Integrating health technology assessment requirements in the clinical development of medicines: the experience from NICE scientific advice.

PubMed

Maignen, François; Osipenko, Leeza; Pinilla-Dominguez, Pilar; Crowe, Emily

2017-03-01

The primary objective of the study was to analyse the proposed clinical development and economic evaluation plans for investigational medicinal products for which pharmaceutical companies have sought health technology assessment (HTA) scientific advice (SA). We have selected and analysed all the scientific advice procedures undertaken by National Institute for Health and Care Excellence (NICE) SA between 1 January 2009 and 3 December 2015 for investigational medicinal products. We have mapped the questions asked by the companies and the areas of advice highlighted in the advice reports to the sections of the NICE methods guide to the technology appraisals (2013). An overwhelming proportion of SA procedures have addressed questions related to the clinical development and specifically the main pivotal efficacy studies. Approximately a quarter of the questions relate to the approaches to economic evaluation. Questions raised in European Medicines Agency-HTA procedures generally focus on clinical efficacy issues whereas cost-effectiveness ones tend to dominate in NICE-only procedures. Our analysis shows that the issues mostly discussed in the HTA SA are the choice of comparator, the generalisability of the clinical trial evidence to the NHS practice and the impact of the clinical trial outcomes on quality of life and survival. Less disagreement with the developers' plans was seen in the choice of clinical endpoints, population definition, position of the technology in the treatment pathway and study design. Scientific advice is designed to improve the quality of evidence and approaches to evidence generation for future regulatory approval and HTA evaluation. Our experience to date suggests that payer requirements are inconsistently integrated in the clinical development programmes. More efforts should be dedicated to demonstrating the clinical value of new medicinal products to patients and key decision-makers.

FRAX(®) Bone Mineral Density Task Force of the 2010 Joint International Society for Clinical Densitometry & International Osteoporosis Foundation Position Development Conference.

PubMed

Lewiecki, E Michael; Compston, Juliet E; Miller, Paul D; Adachi, Jonathan D; Adams, Judith E; Leslie, William D; Kanis, John A

2011-01-01

FRAX(®) is a fracture risk assessment algorithm developed by the World Health Organization in cooperation with other medical organizations and societies. Using easily available clinical information and femoral neck bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA), when available, FRAX(®) is used to predict the 10-year probability of hip fracture and major osteoporotic fracture. These values may be included in country specific guidelines to aid clinicians in determining when fracture risk is sufficiently high that the patient is likely to benefit from pharmacological therapy to reduce that risk. Since the introduction of FRAX(®) into clinical practice, many practical clinical questions have arisen regarding its use. To address such questions, the International Society for Clinical Densitometry (ISCD) and International Osteoporosis Foundations (IOF) assigned task forces to review the best available medical evidence and make recommendations for optimal use of FRAX(®) in clinical practice. Questions were identified and divided into three general categories. A task force was assigned to investigating the medical evidence in each category and developing clinically useful recommendations. The BMD Task Force addressed issues that included the potential use of skeletal sites other than the femoral neck, the use of technologies other than DXA, and the deletion or addition of clinical data for FRAX(®) input. The evidence and recommendations were presented to a panel of experts at the ISCD-IOF FRAX(®) Position Development Conference, resulting in the development of ISCD-IOF Official Positions addressing FRAX(®)-related issues. Copyright © 2011 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

Emerging Roles for Pharmacists in Clinical Implementation of Pharmacogenomics

PubMed Central

Owusu-Obeng, Aniwaa; Weitzel, Kristin W.; Hatton, Randy C.; Staley, Benjamin J.; Ashton, Jennifer; Cooper-Dehoff, Rhonda M.; Johnson, Julie A.

2014-01-01

Pharmacists are uniquely qualified to play essential roles in the clinical implementation of pharmacogenomics. However, specific responsibilities and resources needed for these roles have not been defined. We describe roles for pharmacists that emerged in the clinical implementation of genotype-guided clopidogrel therapy in the University of Florida Health Personalized Medicine Program, summarize preliminary program results, and discuss education, training, and resources needed to support such programs. Planning for University of Florida Health Personalized Medicine Program began in summer 2011 under leadership of a pharmacist, with clinical launch in June 2012 of a clopidogrel-CYP2C19 pilot project aimed at tailoring antiplatelet therapies for patients undergoing percutaneous coronary intervention and stent placement. More than 1000 patients were genotyped in the pilot project in year 1. Essential pharmacist roles and responsibilities that developed and/or emerged required expertise in pharmacy informatics (development of clinical decision support in the electronic medical record), medication safety, medication-use policies and processes, development of group and individual educational strategies, literature analysis, drug information, database management, patient care in targeted areas, logistical issues in genetic testing and follow-up, research and ethical issues, and clinical precepting. In the first 2 years of the program (1 year planning and 1 year postimplementation), a total of 14 different pharmacists were directly and indirectly involved, with effort levels ranging from a few hours per month, to 25–30% effort for the director and associate director, to nearly full-time for residents. Clinical pharmacists are well positioned to implement clinical pharmacogenomics programs, with expertise in pharmacokinetics, pharmacogenomics, informatics, and patient care. Education, training, and practice-based resources are needed to support these roles and to facilitate the development of financially sustainable pharmacist-led clinical pharmacogenomics practice models. PMID:25220280

[Related issues in clinical translational application of adipose-derived stem cells].

PubMed

Liu, Hongwei; Cheng, Biao; Fu, Xiaobing

2012-10-01

To introduce the related issues in the clinical translational application of adipose-derived stem cells (ASCs). The latest papers were extensively reviewed, concerning the issues of ASCs production, management, transportation, use, and safety during clinical application. ASCs, as a new member of adult stem cells family, bring to wide application prospect in the field of regenerative medicine. Over 40 clinical trials using ASCs conducted in 15 countries have been registered on the website (http://www.clinicaltrials.gov) of the National Institutes of Health (NIH), suggesting that ASCs represents a promising approach to future cell-based therapies. In the clinical translational application, the related issues included the quality control standard that management and production should follow, the prevention measures of pathogenic microorganism pollution, the requirements of enzymes and related reagent in separation process, possible effect of donor site, age, and sex in sampling, low temperature storage, product transportation, and safety. ASCs have the advantage of clinical translational application, much attention should be paid to these issues in clinical application to accelerate the clinical translation process.

The prevention of oral mucositis in patients with blood cancers: current concepts and emerging landscapes.

PubMed

Niscola, Pasquale; Tendas, Andrea; Cupelli, Luca; Catalano, Gianfranco; Scaramucci, Laura; Giovannini, Marco; Trinchieri, Vito; Sharma, Atul; Efficace, Fabio; Cartoni, Claudio; Piccioni, Daniela; Perrotti, Alessio; Dentamaro, Teresa; de Fabritiis, Paolo; Keefe, Dorothy M K

2012-12-01

The prevention of oral mucositis (OM) in the management of hematological malignancies continues to represent an unmet clinical need. Addressing this issue has major clinical implications as OM can also greatly impair patient's quality of life. To review currently available measures and investigational agents to prevent OM in hematological patients. we searched for OM and related issues using Medline; the abstract books of the most important hematological and oncological meetings were also reviewed. Many agents targeting different mechanisms of mucosal damage have been applied in order to prevent OM; most of them have failed or its efficacy has not been fully demonstrated. Palifermin is the first pharmaceutical/biological agent approved for the prevention of OM; its use is currently restricted to patients who have received radiotherapy-containing conditioning regimens prior to autologous hematopoietic stem cell transplantation. No clear benefit by this agent has been demonstrated outside of this specific setting and its application should be limited to clinical trials. Other interventions, such as other growth factors and non mitogenic measures are under investigation or in development and their application in the hematological setting is expected in the short term.

Genome engineering in ophthalmology: Application of CRISPR/Cas to the treatment of eye disease.

PubMed

Hung, Sandy S C; McCaughey, Tristan; Swann, Olivia; Pébay, Alice; Hewitt, Alex W

2016-07-01

The Clustered Regularly Interspaced Short Palindromic Repeat (CRISPR) and CRISPR-associated protein (Cas) system has enabled an accurate and efficient means to edit the human genome. Rapid advances in this technology could results in imminent clinical application, and with favourable anatomical and immunological profiles, ophthalmic disease will be at the forefront of such work. There have been a number of breakthroughs improving the specificity and efficacy of CRISPR/Cas-mediated genome editing. Similarly, better methods to identify off-target cleavage sites have also been developed. With the impending clinical utility of CRISPR/Cas technology, complex ethical issues related to the regulation and management of the precise applications of human gene editing must be considered. This review discusses the current progress and recent breakthroughs in CRISPR/Cas-based gene engineering, and outlines some of the technical issues that must be addressed before gene correction, be it in vivo or in vitro, is integrated into ophthalmic care. We outline a clinical pipeline for CRISPR-based treatments of inherited eye diseases and provide an overview of the important ethical implications of gene editing and how these may influence the future of this technology. Copyright © 2016 Elsevier Ltd. All rights reserved.

Vitamin D supplementation for osteoporosis in older adults: can we make it help better?

PubMed

Dong, C-H; Gao, Q-M; Wang, Z-M; Wang, A-M; Zhen, P

2016-11-01

With the increase of the average age of our population, the incidence of diseases specific for older adults has been increasing. One of such diseases is osteoporosis. The true incidence of osteoporosis is unknown. But the estimates indicate that this disease affects wide proportions of the population, ranging in millions or even ten millions in large countries like the United States. As this poses a significant burden on the health care system, interventions that could prevent or treat this condition are in the focus of clinical research. Vitamin D, the determinant of bone health, has been tested in clinical studies as the agent to treat osteoporosis. Despite the progress, there is still some controversy about the targeted blood levels of vitamin D, most efficient way to supplement this vitamin, and clinical efficacy of this supplementation in the elderly.In the present review, we will highlight the metabolism of vitamin D and the aforementioned unresolved issues, as well as review the recent interventional studies on vitamin D supplementation. In the present review, we will highlight the metabolism of vitamin D and the aforementioned unresolved issues, as well as review the recent interventional studies on vitamin D supplementation.

GENDER ISSUES: Medical Support for Female Soldiers Deployed to Bosnia

DTIC Science & Technology

1999-03-01

indicate how many visits were for health services such as obtaining birth control refill prescriptions or for specific medical problems such as pelvic...as yeast infections and urinary tract infections. They could also test for pregnancy and dispense birth control . The clinics, however, were not...these briefings were (1) birth control and sexually transmitted diseases; (2) female hygiene in 8Not all 234 women taking our survey responded to our

Recent advances in MRI technology: Implications for image quality and patient safety

PubMed Central

Sobol, Wlad T.

2012-01-01

Recent advances in MRI technology are presented, with emphasis on how this new technology impacts clinical operations (better image quality, faster exam times, and improved throughput). In addition, implications for patient safety are discussed with emphasis on the risk of patient injury due to either high local specific absorption rate (SAR) or large cumulative energy doses delivered during long exam times. Patient comfort issues are examined as well. PMID:23961024

Challenges in the doctor-patient relationship: 12 tips for more effective peer group discussion.

PubMed

Wilson, Hamish

2015-09-01

In New Zealand, almost all general practitioners are members of peer groups, which provide opportunities for both clinical discussion and collegial support. This article proposes that peer groups can also be a useful medium for exploring specific challenges within the doctor-patient relationship. However, the peer group culture needs to be receptive to this particular goal. Structured discussion can help peer group members explore interpersonal issues more thoroughly.

Clinical and Molecular Characteristics and Burden of Kidney Cancer Among Hispanics and Native Americans: Steps Toward Precision Medicine.

PubMed

Batai, Ken; Bergersen, Andrew; Price, Elinora; Hynes, Kieran; Ellis, Nathan A; Lee, Benjamin R

2018-06-01

Cancer disparities in Native Americans (NAs) and Hispanic Americans (HAs) vary significantly in terms of cancer incidence and mortality rates across geographic regions. This review reports that kidney and renal pelvis cancers are unevenly affecting HAs and NAs compared to European Americans of non-Hispanic origin, and that currently there is significant need for improved data and reporting to be able to advance toward genomic-based precision medicine for the assessment of such cancers in these medically underserved populations. More specifically, in states along the US-Mexico border, HAs and NAs have higher kidney cancer incidence rates as well as a higher prevalence of kidney cancer risk factors, including obesity and chronic kidney disease. They are also more likely to receive suboptimal care compared to European Americans. Furthermore, they are underrepresented in epidemiologic, clinical, and molecular genomic studies of kidney cancer. Therefore, we maintain that progress in precision medicine for kidney cancer care requires an understanding of various factors among HAs and NAs, including the real kidney cancer burden, variations in clinical care, issues related to access to care, and specific clinical and molecular characteristics. Copyright © 2018 Elsevier Inc. All rights reserved.

Assessing severity of patients with community-acquired pneumonia.

PubMed

Pereira, Jose Manuel; Paiva, Jose Artur; Rello, Jordi

2012-06-01

Despite all advances in its management, community-acquired pneumonia (CAP) is still an important cause of morbidity and mortality requiring a great consumption of health, social, and economic resources. An early and adequate severity assessment is of paramount importance to provide optimized care to these patients. In the last 2 decades, this issue has been the subject of extensive research. Based on 30 day mortality, several prediction rules have been proposed to aid clinicians in deciding on the appropriate site of care. In spite of being well validated, their sensitivity and specificity vary, which limits their widespread use. The utility of biomarkers to overcome this problem has been investigated. At this moment, their full clinical value remains undetermined, and no single biomarker is consistently ideal for assessing CAP severity. Biomarkers should be seen as a complement rather than superseding clinical judgment or validated clinical scores. The search for a gold standard is not over, and new tools, like bacterial DNA load, are in the pipeline. Until then, CAP severity assessment should be based in three key points: a pneumonia-specific score, biomarkers, and clinical judgment. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Cost consideration in the clinical guidance documents of physician specialty societies in the United States.

PubMed

Schwartz, Jennifer A T; Pearson, Steven D

2013-06-24

Despite increasing concerns regarding the cost of health care, the consideration of costs in the development of clinical guidance documents by physician specialty societies has received little analysis. To evaluate the approach to consideration of cost in publicly available clinical guidance documents and methodological statements produced between 2008 and 2012 by the 30 largest US physician specialty societies. Qualitative document review. Whether costs are considered in clinical guidance development, mechanism of cost consideration, and the way that cost issues were used in support of specific clinical practice recommendations. Methodological statements for clinical guidance documents indicated that 17 of 30 physician societies (57%) explicitly integrated costs, 4 (13%) implicitly considered costs, 3 (10%) intentionally excluded costs, and 6 (20%) made no mention. Of the 17 societies that explicitly integrated costs, 9 (53%) consistently used a formal system in which the strength of recommendation was influenced in part by costs, whereas 8 (47%) were inconsistent in their approach or failed to mention the exact mechanism for considering costs. Among the 138 specific recommendations in these guidance documents that included cost as part of the rationale, the most common form of recommendation (50 [36%]) encouraged the use of a specific medical service because of equal effectiveness and lower cost. Slightly more than half of the largest US physician societies explicitly consider costs in developing their clinical guidance documents; among these, approximately half use an explicit mechanism for integrating costs into the strength of recommendations. Many societies remain vague in their approach. Physician specialty societies should demonstrate greater transparency and rigor in their approach to cost consideration in documents meant to influence care decisions.

Safety and clinical performance of acoustic reflex tests.

PubMed

Hunter, L L; Ries, D T; Schlauch, R S; Levine, S C; Ward, W D

1999-12-01

Safety and effectiveness of acoustic reflex tests are important issues because these tests are widely applied to screen for retrocochlear pathology. Previous studies have reported moderately high sensitivity and specificity for detection of acoustic neuroma. However, there have been reports of possible iatrogenic hearing loss resulting from acoustic reflex threshold (ART) and decay (ARD) tests. This study assessed safety and clinical performance of ART tests for detection of acoustic neuroma. We report a case in which ARD testing resulted in a significant bilateral permanent threshold shift. This case was the impetus for us to investigate the clinical utility of ART and ARD tests. We analyzed sensitivity and specificity of ART, as well as asymmetry in pure-tone thresholds (PTT) for detection of acoustic neuroma in 56 tumor and 108 non-tumor ears. Sensitivity and specificity were higher for PTT asymmetry than for ART. Ipsilateral ART at 1000 Hz had poor sensitivity and specificity for detection of acoustic neuroma, and involves some potential risk to residual hearing for presentation levels higher than 115 dB SPL. Approximately half of the acoustic neuroma group had ipsilateral ARTs that would require administration of ARD tests at levels exceeding 115 dB SPL. Therefore, we conclude that PTT asymmetry is a more effective test for detection of acoustic neuroma, and involves no risk to residual hearing. Future studies of contralateral reflex threshold and ARD in combination with PTT asymmetry are recommended.

Using discrete choice experiments within a cost-benefit analysis framework: some considerations.

PubMed

McIntosh, Emma

2006-01-01

A great advantage of the stated preference discrete choice experiment (SPDCE) approach to economic evaluation methodology is its immense flexibility within applied cost-benefit analyses (CBAs). However, while the use of SPDCEs in healthcare has increased markedly in recent years there has been a distinct lack of equivalent CBAs in healthcare using such SPDCE-derived valuations. This article outlines specific issues and some practical suggestions for consideration relevant to the development of CBAs using SPDCE-derived benefits. The article shows that SPDCE-derived CBA can adopt recent developments in cost-effectiveness methodology including the cost-effectiveness plane, appropriate consideration of uncertainty, the net-benefit framework and probabilistic sensitivity analysis methods, while maintaining the theoretical advantage of the SPDCE approach. The concept of a cost-benefit plane is no different in principle to the cost-effectiveness plane and can be a useful tool for reporting and presenting the results of CBAs.However, there are many challenging issues to address for the advancement of CBA methodology using SPCDEs within healthcare. Particular areas for development include the importance of accounting for uncertainty in SPDCE-derived willingness-to-pay values, the methodology of SPDCEs in clinical trial settings and economic models, measurement issues pertinent to using SPDCEs specifically in healthcare, and the importance of issues such as consideration of the dynamic nature of healthcare and the resulting impact this has on the validity of attribute definitions and context.

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.

Integrated health practices: development of a graduate nursing program.

PubMed

Jossens, Marilyn O R; Ganley, Barbara J

2006-01-01

This article describes pedagogical issues in the development of a graduate nursing program in Integrated Health Practices (IHP), reports early experiences in the program, and asserts the importance of a graduate program in the specialty. The experience is described, and unique pedagogical issues encountered are discussed. While noting the contributions made to health and health care by Western medicine and nursing practice, the authors elaborate on the benefits of integrating western health care with less technological, less invasive, and less expensive holistic approaches. Diverse populations often require attention to specific chronic conditions, rather than to acute conditions, and constitutional requirements for overall health may be influenced by diverse health philosophies and practices. These requirements may be grounded in cultural and religious beliefs that must be incorporated into culturally sensitive plans of care. Clinical nurse specialists in IHP can offer knowledge and leadership to nursing practice, which address these complex, yet subtle health care issues.

Co-Occurring Disorders in Substance Abuse Treatment: Issues and Prospects

PubMed Central

Flynn, Patrick M.; Brown, Barry S.

2008-01-01

This paper explores the epidemiology of co-occurring disorders with an emphasis on the implications of study findings for the functioning and potential of substance abuse treatment. Severity of disorder is discussed as an issue that may have particular significance for the selection of specialized as opposed to traditional substance abuse treatment forms. Exploration is made, as well, of the resources currently available to substance abuse treatment, especially the human resources available, and the implications of resource availability for undertaking initiatives specific to co-occurring disorder. Findings from standard and enhanced treatment for comorbid individuals are examined in an effort to clarify areas of need for specialized and typical treatment personnel. Issues are raised for consideration by the clinical research and treatment provider communities in terms of assessment and diagnosis, manpower and training, and response to the challenge of relapse in this population. PMID:17574791

Choice Impulsivity: Definitions, Measurement Issues, and Clinical Implications

PubMed Central

Hamilton, Kristen R.; Mitchell, Marci R.; Wing, Victoria C.; Balodis, Iris M.; Bickel, Warren K.; Fillmore, Mark; Lane, Scott D.; Lejuez, C. W.; Littlefield, Andrew K.; Luijten, Maartje; Mathias, Charles W.; Mitchell, Suzanne H.; Napier, T. Celeste; Reynolds, Brady; Schütz, Christian G.; Setlow, Barry; Sher, Kenneth J.; Swann, Alan C.; Tedford, Stephanie E.; White, Melanie J.; Winstanley, Catharine A.; Yi, Richard; Potenza, Marc N.; Moeller, F. Gerard

2015-01-01

Background Impulsivity critically relates to many psychiatric disorders. Given the multi-faceted construct that impulsivity represents, defining core aspects of impulsivity is vital for the assessment and understanding of clinical conditions. Choice impulsivity (CI), involving the preferential selection of smaller sooner rewards over larger later rewards, represents one important type of impulsivity. Method The International Society for Research on Impulsivity (InSRI) convened to discuss the definition and assessment of CI and provide recommendations regarding measurement across species. Results Commonly used preclinical and clinical CI behavioral tasks are described, and considerations for each task are provided to guide CI task selection. Differences in assessment of CI (self-report, behavioral) and calculating CI indices (e.g., area-under-the-curve, indifference point, steepness of discounting curve) are discussed along with properties of specific behavioral tasks used in preclinical and clinical settings. Conclusions The InSRI group recommends inclusion of measures of CI in human studies examining impulsivity. Animal studies examining impulsivity should also include assessments of CI and these measures should be harmonized in accordance with human studies of the disorders being modeled in the preclinical investigations. The choice of specific CI measures to be included should be based on the goals of the study and existing preclinical and clinical literature using established CI measures. PMID:25867841

Women physicians as healthcare leaders: a qualitative study.

PubMed

Roth, Virginia R; Theriault, Anne; Clement, Chris; Worthington, Jim

2016-06-20

Purpose - The purpose of this paper is to explore the under-representation of women physicians in clinical leadership by examining the issue from their perspective. Design/methodology/approach - The authors used large group engagement methods to explore the experiences and perceptions of women physicians. In order to capture common themes across this group as a whole, participants were selected using purposeful sampling. Data were analysed using a structured thematic analysis procedure. Findings - This paper provides empirical insights into the influences affecting women physicians' decision to participate in leadership. The authors found that they often exclude themselves because the costs of leadership outweigh the benefits. Potential barriers unique to healthcare include the undervaluing of leadership by physician peers and perceived lack of support by nursing. Research limitations/implications - This study provides an in-depth examination of why women physicians are under-represented in clinical leadership from the perspective of those directly involved. Further studies are needed to confirm the generalizability of these findings and potential differences between demographic groups of physicians. Practical implications - Healthcare organizations seeking to increase the participation of women physicians in leadership should focus on modifying the perceived costs of leadership and highlighting the potential benefits. Large group engagement methods can be an effective approach to engage physicians on specific issues and mobilize grass-roots support for change. Originality/value - This exploratory study provides insights on the barriers and enablers to leadership specific to women physicians in the clinical setting. It provides a reference for healthcare organizations seeking to develop and diversify their leadership talent.

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.

WE-F-201-00: Practical Guidelines for Commissioning Advanced Brachytherapy Dose Calculation Algorithms

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

2015-06-15

With the recent introduction of heterogeneity correction algorithms for brachytherapy, the AAPM community is still unclear on how to commission and implement these into clinical practice. The recently-published AAPM TG-186 report discusses important issues for clinical implementation of these algorithms. A charge of the AAPM-ESTRO-ABG Working Group on MBDCA in Brachytherapy (WGMBDCA) is the development of a set of well-defined test case plans, available as references in the software commissioning process to be performed by clinical end-users. In this practical medical physics course, specific examples on how to perform the commissioning process are presented, as well as descriptions of themore » clinical impact from recent literature reporting comparisons of TG-43 and heterogeneity-based dosimetry. Learning Objectives: Identify key clinical applications needing advanced dose calculation in brachytherapy. Review TG-186 and WGMBDCA guidelines, commission process, and dosimetry benchmarks. Evaluate clinical cases using commercially available systems and compare to TG-43 dosimetry.« less

Supportive Care Treatment Guidelines: Value, Limitations, and Opportunities

PubMed Central

Peterson, Douglas E.; Bensadoun, Rene-Jean; Lalla, Rajesh V.; McGuire, Deborah B.

2013-01-01

Evidence-based guidelines in clinical oncology practice are now prominent, with emphasis on clinical, health outcome and economic perspectives. Given the complexity of cancer management, a multidisciplinary approach is essential. Evidence-based guidelines to address supportive cancer care have merged expert opinion, systematic evaluation of clinical and research data, and meta-analyses of clinical trials. Production of supportive care guidelines by the interdisciplinary team is dependent on sufficient high-quality research studies. Once published, it is essential they be customized at institutional and national levels. Implementation in clinical practice is perhaps the greatest challenge. Optimal management occurs through integration of country-specific issues, including care access, healthcare resources, information technology, and national coordination of healthcare practices. The purpose of this article is to: (1) provide an overview of interdisciplinary cancer management using evidence-based guidelines; (2) delineate the theory and practice of guideline dissemination, utilization and outcome assessment; and (3) recommend future research strategies to maximize guidelines use in clinical practice. PMID:21600365

Healthcare transition in persons with intellectual disabilities: general issues, the Maastricht model, and Prader-Willi syndrome.

PubMed

Schrander-Stumpel, Constance T R M; Sinnema, Margje; van den Hout, Lieke; Maaskant, Marian A; van Schrojenstein Lantman-de Valk, Henny M J; Wagemans, Annemieke; Schrander, Jaap J P; Curfs, Leopold M G

2007-08-15

In current healthcare, transitional healthcare is a very important and timely issue. Thanks to the major advances made in medical care and technology, many children with childhood onset diseases and/or genetic syndromes survive to adulthood. These children are at risk of not being provided with adequate healthcare as they reach adulthood. Healthcare transition is an essential part of healthcare provision, referred to as the shift from one type of healthcare to another. In Maastricht, we developed a transition/out clinic led by a medical doctor specialized in persons with intellectual disability (ID), together with a clinical geneticist. We aim to coordinate healthcare issues based on guidelines if available. Also questions concerning living, daily activities, relations, sexuality, and sterilization can be discussed. The aging process of persons with ID has been a topic of interest in recent years. Little is known about the aging process of people with specific syndromes, except for persons with Down syndrome. We present some data of a recent questionnaire study in persons with Prader-Willi syndrome. In only 50% in persons with a clinical diagnosis genetic test results could be reported. The majority of persons were obese. Diabetes mellitus, hypertension, skin problems, sleep apnea, and hormonal problems like osteoporosis and hypothyroidism were common. Psychiatric problems were frequent, especially in the persons with uniparental disomy. Osteoporosis and sleep apnoea seem to be underestimated. Further longitudinal research is necessary for a better understanding of the aging process in PWS. (c) 2007 Wiley-Liss, Inc.

Can non‐clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium

PubMed Central

Park, Eunjung; Gintant, Gary A; Bi, Daoqin; Kozeli, Devi; Pettit, Syril D; Skinner, Matthew; Willard, James; Wisialowski, Todd; Koerner, John; Valentin, Jean‐Pierre

2018-01-01

Background and Purpose Translation of non‐clinical markers of delayed ventricular repolarization to clinical prolongation of the QT interval corrected for heart rate (QTc) (a biomarker for torsades de pointes proarrhythmia) remains an issue in drug discovery and regulatory evaluations. We retrospectively analysed 150 drug applications in a US Food and Drug Administration database to determine the utility of established non‐clinical in vitro IKr current human ether‐à‐go‐go‐related gene (hERG), action potential duration (APD) and in vivo (QTc) repolarization assays to detect and predict clinical QTc prolongation. Experimental Approach The predictive performance of three non‐clinical assays was compared with clinical thorough QT study outcomes based on free clinical plasma drug concentrations using sensitivity and specificity, receiver operating characteristic (ROC) curves, positive (PPVs) and negative predictive values (NPVs) and likelihood ratios (LRs). Key Results Non‐clinical assays demonstrated robust specificity (high true negative rate) but poor sensitivity (low true positive rate) for clinical QTc prolongation at low‐intermediate (1×–30×) clinical exposure multiples. The QTc assay provided the most robust PPVs and NPVs (ability to predict clinical QTc prolongation). ROC curves (overall test accuracy) and LRs (ability to influence post‐test probabilities) demonstrated overall marginal performance for hERG and QTc assays (best at 30× exposures), while the APD assay demonstrated minimal value. Conclusions and Implications The predictive value of hERG, APD and QTc assays varies, with drug concentrations strongly affecting translational performance. While useful in guiding preclinical candidates without clinical QT prolongation, hERG and QTc repolarization assays provide greater value compared with the APD assay. PMID:29181850

Clinical Response to Vedolizumab in Ulcerative Colitis Patients Is Associated with Changes in Integrin Expression Profiles.

PubMed

Fuchs, Friederike; Schillinger, Daniela; Atreya, Raja; Hirschmann, Simon; Fischer, Sarah; Neufert, Clemens; Atreya, Imke; Neurath, Markus F; Zundler, Sebastian

2017-01-01

Despite large clinical success, deeper insights into the immunological effects of vedolizumab therapy for inflammatory bowel diseases are scarce. In particular, the reasons for differential clinical response in individual patients, the precise impact on the equilibrium of integrin-expressing T cell subsets, and possible associations between these issues are not clear. Blood samples from patients receiving clinical vedolizumab therapy were sequentially collected and analyzed for expression of integrins and chemokine receptors on T cells. Moreover, clinical and laboratory data from the patients were collected, and changes between homing marker expression and clinical parameters were analyzed for possible correlations. While no significant correlation of changes in integrin expression and changes in outcome parameters were identified in Crohn's disease (CD), increasing α4β7 levels in ulcerative colitis (UC) seemed to be associated with favorable clinical development, whereas increasing α4β1 and αEβ7 correlated with negative changes in outcome parameters. Changes in α4β1 integrin expression after 6 weeks were significantly different in responders and non-responders to vedolizumab therapy as assessed after 16 weeks with a cutoff of +4.2% yielding 100% sensitivity and 100% specificity in receiver-operator-characteristic analysis. Our data show that clinical response to vedolizumab therapy in UC but not in CD is associated with specific changes in integrin expression profiles opening novel avenues for mechanistic research and possibly prediction of response to therapy.

Perceived comfort level of medical students and residents in handling clinical ethics issues.

PubMed

Silverman, Henry J; Dagenais, Julien; Gordon-Lipkin, Eliza; Caputo, Laura; Christian, Matthew W; Maidment, Bert W; Binstock, Anna; Oyalowo, Akinbowale; Moni, Malini

2013-01-01

Studies have shown that medical students and residents believe that their ethics preparation has been inadequate for handling ethical conflicts. The objective of this study was to determine the self-perceived comfort level of medical students and residents in confronting clinical ethics issues. Clinical medical students and residents at the University of Maryland School of Medicine completed a web-based survey between September 2009 and February 2010. The survey consisted of a demographic section, questions regarding the respondents' sense of comfort in handling a variety of clinical ethics issues, and a set of knowledge-type questions in ethics. Survey respondents included 129 medical students (response rate of 40.7%) and 207 residents (response rate of 52.7%). There were only a few clinical ethics issues with which more than 70% of the respondents felt comfortable in addressing. Only a slight majority (60.8%) felt prepared, in general, to handle clinical situations involving ethics issues, and only 44.1% and 53.2% agreed that medical school and residency training, respectively, helped prepare them to handle such issues. Prior ethics training was not associated with these responses, but there was an association between the level of training (medical students vs residents) and the comfort level with many of the clinical ethics issues. Medical educators should include ethics educational methods within the context of real-time exposure to medical ethics dilemmas experienced by physicians-in-training.

Chimeric antigen receptor for adoptive immunotherapy of cancer: latest research and future prospects.

PubMed

Shi, Huan; Sun, Meili; Liu, Lin; Wang, Zhehai

2014-09-21

Chimeric antigen receptors (CARs) are recombinant receptors that combine the specificity of an antigen-specific antibody with the T-cell's activating functions. Initial clinical trials of genetically engineered CAR T cells have significantly raised the profile of T cell therapy, and great efforts have been made to improve this approach. In this review, we provide a structural overview of the development of CAR technology and highlight areas that require further refinement. We also discuss critical issues related to CAR therapy, including the optimization of CAR T cells, the route of administration, CAR toxicity and the blocking of inhibitory molecules.

Nurse awareness of clinical research: a survey in a Japanese University Hospital

PubMed Central

2014-01-01

Background Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research. Methods As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed. Results Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse. Conclusions These findings suggest that clinical nurses have only limited knowledge on clinical research and the importance to have chances to make nurses aware of clinical research-related issues is suggested to establish an extended research team. Because of the study limitations, further study is warranted to determine the role of clinical nurses in establishing a suitable infrastructure for ethical pursuit of clinical research. PMID:24989623

Applications of Chondrocyte-Based Cartilage Engineering: An Overview

PubMed Central

Eo, Seong-Hui; Abbas, Qamar; Ahmed, Madiha

2016-01-01

Chondrocytes are the exclusive cells residing in cartilage and maintain the functionality of cartilage tissue. Series of biocomponents such as different growth factors, cytokines, and transcriptional factors regulate the mesenchymal stem cells (MSCs) differentiation to chondrocytes. The number of chondrocytes and dedifferentiation are the key limitations in subsequent clinical application of the chondrocytes. Different culture methods are being developed to overcome such issues. Using tissue engineering and cell based approaches, chondrocytes offer prominent therapeutic option specifically in orthopedics for cartilage repair and to treat ailments such as tracheal defects, facial reconstruction, and urinary incontinence. Matrix-assisted autologous chondrocyte transplantation/implantation is an improved version of traditional autologous chondrocyte transplantation (ACT) method. An increasing number of studies show the clinical significance of this technique for the chondral lesions treatment. Literature survey was carried out to address clinical and functional findings by using various ACT procedures. The current study was conducted to study the pharmacological significance and biomedical application of chondrocytes. Furthermore, it is inferred from the present study that long term follow-up studies are required to evaluate the potential of these methods and specific positive outcomes. PMID:27631002

Translational approaches to obsessive-compulsive disorder: from animal models to clinical treatment

PubMed Central

Fineberg, NA; Chamberlain, SR; Hollander, E; Boulougouris, V; Robbins, TW

2011-01-01

Obsessive-compulsive disorder (OCD) is characterized by obsessions (intrusive thoughts) and compulsions (repetitive ritualistic behaviours) leading to functional impairment. Accumulating evidence links these conditions with underlying dysregulation of fronto-striatal circuitry and monoamine systems. These abnormalities represent key targets for existing and novel treatment interventions. However, the brain bases of these conditions and treatment mechanisms are still not fully elucidated. Animal models simulating the behavioural and clinical manifestations of the disorder show great potential for augmenting our understanding of the pathophysiology and treatment of OCD. This paper provides an overview of what is known about OCD from several perspectives. We begin by describing the clinical features of OCD and the criteria used to assess the validity of animal models of symptomatology; namely, face validity (phenomenological similarity between inducing conditions and specific symptoms of the human phenomenon), predictive validity (similarity in response to treatment) and construct validity (similarity in underlying physiological or psychological mechanisms). We then survey animal models of OC spectrum conditions within this framework, focusing on (i) ethological models; (ii) genetic and pharmacological models; and (iii) neurobehavioural models. We also discuss their advantages and shortcomings in relation to their capacity to identify potentially efficacious new compounds. It is of interest that there has been rather little evidence of ‘false alarms’ for therapeutic drug effects in OCD models which actually fail in the clinic. While it is more difficult to model obsessive cognition than compulsive behaviour in experimental animals, it is feasible to infer cognitive inflexibility in certain animal paradigms. Finally, key future neurobiological and treatment research areas are highlighted. LINKED ARTICLES This article is part of a themed issue on Translational Neuropharmacology. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2011.164.issue-4 PMID:21486280

Added value of involving patients in the first step of multidisciplinary guideline development: a qualitative interview study among infertile patients.

PubMed

den Breejen, Elvira M E; Hermens, Rosella P M G; Galama, Wienke H; Willemsen, Wim N P; Kremer, Jan A M; Nelen, Willianne L D M

2016-06-01

Patient involvement in scoping the guideline is emphasized, but published initiatives actively involving patients are generally limited to the writing and reviewing phase. To assess patients' added value to the scoping phase of a multidisciplinary guideline on infertility. Qualitative interview study. We conducted interviews among 12 infertile couples and 17 professionals. We listed and compared the couples' and professionals' key clinical issues (=care aspects that need improvement) to be addressed in the guideline according to four domains: current guidelines, professionals, patients and organization of care. Main key clinical issues suggested by more than three quarters of the infertile couples and/or at least two professionals were identified and compared. Overall, we identified 32 key clinical issues among infertile couples and 23 among professionals. Of the defined main key clinical issues, infertile couples mentioned eight issues that were not mentioned by the professionals. These main key clinical issues mainly concerned patient-centred (e.g. poor information provision and poor alignment of care) aspects of care on the professional and organizational domain. Both groups mentioned two main key clinical issues collectively that were interpreted differently: the lack of emotional support and respect for patients' values. Including patients from the first phase of the guideline development process leads to valuable additional main key clinical issues for the next step of a multidisciplinary guideline development process and broadens the scope of the guideline, particularly regarding patient-centredness and organizational issues from a patients' perspective. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Cardiac imaging: working towards fully-automated machine analysis & interpretation

PubMed Central

Slomka, Piotr J; Dey, Damini; Sitek, Arkadiusz; Motwani, Manish; Berman, Daniel S; Germano, Guido

2017-01-01

Introduction Non-invasive imaging plays a critical role in managing patients with cardiovascular disease. Although subjective visual interpretation remains the clinical mainstay, quantitative analysis facilitates objective, evidence-based management, and advances in clinical research. This has driven developments in computing and software tools aimed at achieving fully automated image processing and quantitative analysis. In parallel, machine learning techniques have been used to rapidly integrate large amounts of clinical and quantitative imaging data to provide highly personalized individual patient-based conclusions. Areas covered This review summarizes recent advances in automated quantitative imaging in cardiology and describes the latest techniques which incorporate machine learning principles. The review focuses on the cardiac imaging techniques which are in wide clinical use. It also discusses key issues and obstacles for these tools to become utilized in mainstream clinical practice. Expert commentary Fully-automated processing and high-level computer interpretation of cardiac imaging are becoming a reality. Application of machine learning to the vast amounts of quantitative data generated per scan and integration with clinical data also facilitates a move to more patient-specific interpretation. These developments are unlikely to replace interpreting physicians but will provide them with highly accurate tools to detect disease, risk-stratify, and optimize patient-specific treatment. However, with each technological advance, we move further from human dependence and closer to fully-automated machine interpretation. PMID:28277804

PubMed-supported clinical term weighting approach for improving inter-patient similarity measure in diagnosis prediction.

PubMed

Chan, Lawrence Wc; Liu, Ying; Chan, Tao; Law, Helen Kw; Wong, S C Cesar; Yeung, Andy Ph; Lo, K F; Yeung, S W; Kwok, K Y; Chan, William Yl; Lau, Thomas Yh; Shyu, Chi-Ren

2015-06-02

Similarity-based retrieval of Electronic Health Records (EHRs) from large clinical information systems provides physicians the evidence support in making diagnoses or referring examinations for the suspected cases. Clinical Terms in EHRs represent high-level conceptual information and the similarity measure established based on these terms reflects the chance of inter-patient disease co-occurrence. The assumption that clinical terms are equally relevant to a disease is unrealistic, reducing the prediction accuracy. Here we propose a term weighting approach supported by PubMed search engine to address this issue. We collected and studied 112 abdominal computed tomography imaging examination reports from four hospitals in Hong Kong. Clinical terms, which are the image findings related to hepatocellular carcinoma (HCC), were extracted from the reports. Through two systematic PubMed search methods, the generic and specific term weightings were established by estimating the conditional probabilities of clinical terms given HCC. Each report was characterized by an ontological feature vector and there were totally 6216 vector pairs. We optimized the modified direction cosine (mDC) with respect to a regularization constant embedded into the feature vector. Equal, generic and specific term weighting approaches were applied to measure the similarity of each pair and their performances for predicting inter-patient co-occurrence of HCC diagnoses were compared by using Receiver Operating Characteristics (ROC) analysis. The Areas under the curves (AUROCs) of similarity scores based on equal, generic and specific term weighting approaches were 0.735, 0.728 and 0.743 respectively (p < 0.01). In comparison with equal term weighting, the performance was significantly improved by specific term weighting (p < 0.01) but not by generic term weighting. The clinical terms "Dysplastic nodule", "nodule of liver" and "equal density (isodense) lesion" were found the top three image findings associated with HCC in PubMed. Our findings suggest that the optimized similarity measure with specific term weighting to EHRs can improve significantly the accuracy for predicting the inter-patient co-occurrence of diagnosis when compared with equal and generic term weighting approaches.

14 CFR 91.1017 - Amending program manager's management specifications.

Code of Federal Regulations, 2014 CFR

2014-01-01

... proposed amendment. (2) The Flight Standards District Office that issued the program manager's management... presented, the Flight Standards District Office that issued the program manager's management specifications... Standards District Office that issued the program manager's management specifications issues an amendment of...

14 CFR 91.1017 - Amending program manager's management specifications.

Code of Federal Regulations, 2012 CFR

2012-01-01

... proposed amendment. (2) The Flight Standards District Office that issued the program manager's management... presented, the Flight Standards District Office that issued the program manager's management specifications... Standards District Office that issued the program manager's management specifications issues an amendment of...

Best practices for clinical pathology testing in carcinogenicity studies.

PubMed

Young, Jamie K; Hall, Robert L; O'Brien, Peter; Strauss, Volker; Vahle, John L

2011-02-01

The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.

Rural school-based telehealth: how to make it happen.

PubMed

Burke, Bryan; Bynum, Ann; Hall-Barrow, Julie; Ott, Rachel; Albright, Margaret

2008-11-01

When organizing new health care interventions among a rural population, a careful planning process respecting community-specific considerations should be used. The project objective centered on the successful implementation of a school-based telehealth clinic serving a rural, health-disparate population. Using an American Academy of Pediatrics Community Access to Child Health planning grant, a needs assessment of the Delta community was conducted. In synthesizing the results of this planning project, consensually addressed issues led to establishing a pilot school-based telehealth clinic within the rural county schools. Seven essential steps emerged as a set of guidelines that entities might consider in introducing a telemedicine school-based service in a rural community. The steps included assessing local and regional needs, securing community support and establishing goals, evaluating resources, configuring logistics, training staff, informing parents, and launching the clinic. Proper planning is crucial to the establishment of a rural school-based telehealth clinic.

SAFETY: an integrated clinical reasoning and reflection framework for undergraduate nursing students.

PubMed

Hicks Russell, Bedelia; Geist, Melissa J; House Maffett, Jenny

2013-01-01

Nurse educators can no longer focus on imparting to students knowledge that is merely factual and content specific. Activities that provide students with opportunities to apply concepts in real-world scenarios can be powerful tools. Nurse educators should take advantage of student-patient interactions to model clinical reasoning and allow students to practice complex decision making throughout the entire curriculum. In response to this change in nursing education, faculty in a pediatric course designed a reflective clinical reasoning activity based on the SAFETY template, which is derived from the National Council of State Boards of Nursing RN practice analysis. Students were able to prioritize key components of nursing care, as well as integrate practice issues such as delegation, Health Insurance Portability and Accountability Act violations, and questioning the accuracy of orders. SAFETY is proposed as a framework for integration of content knowledge, clinical reasoning, and reflection on authentic professional nursing concerns. Copyright 2012, SLACK Incorporated.

Occurrence of spvA Virulence Gene and Clinical Significance for Multidrug-Resistant Salmonella Strains ▿

PubMed Central

Gebreyes, Wondwossen A.; Thakur, Siddhartha; Dorr, Paul; Tadesse, Daniel A.; Post, Karen; Wolf, Leslie

2009-01-01

Nontyphoidal Salmonella strains are important reservoirs of antimicrobial resistance. An important issue that has not been investigated is whether the multiresistant Salmonella strains are more virulent than their susceptible counterparts. Salmonella isolates collected from clinical human (n = 888) and porcine (n = 2,120) cases at the same time period and geographic location were investigated. Antimicrobial susceptibility, PCR analysis for the spvA virulence gene, and pulsed-field gel electrophoresis (PFGE) genotyping were done. Carriage of spvA was associated with multidrug-resistant (MDR) type ACSSuT strains (odds ratio, 7.1; P < 0.05), a type often implicated in bacteremic human cases. PFGE revealed that clinical isolates from pigs were more clonally related to those of human origin than the nonclinical porcine isolates. The findings suggest that MDR strains that also carry specific virulence factors are more likely to be of clinical significance. PMID:19116354

The dynamic development of gender variability.

PubMed

Fausto-Sterling, Anne

2012-01-01

We diagram and discuss theories of gender identity development espoused by the clinical groups represented in this special issue. We contend that theories of origin relate importantly to clinical practice, and argue that the existing clinical theories are under-developed. Therefore, we develop a dynamic systems framework for gender identity development. Specifically, we suggest that critical aspects of presymbolic gender embodiment occur during infancy as part of the synchronous interplay of caregiver-infant dyads. By 18 months, a transition to symbolic representation and the beginning of an internalization of a sense of gender can be detected and consolidation is quite evident by 3 years of age. We conclude by suggesting empirical studies that could expand and test this framework. With the belief that better, more explicit developmental theory can improve clinical practice, we urge that clinicians take a dynamic developmental view of gender identity formation into account.

Cloning and expansion of antigen-specific T cells using iPS cell technology: development of "off-the-shelf" T cells for the use in allogeneic transfusion settings.

PubMed

Kawamoto, Hiroshi; Masuda, Kyoko; Nagano, Seiji; Maeda, Takuya

2018-03-01

Recent advances in adoptive immunotherapy using cytotoxic T lymphocytes (CTLs) have led to moderate therapeutic anti-cancer effects in clinical trials. However, a critical issue, namely that CTLs collected from patients are easily exhausted during expansion culture, has yet to be solved. To address this issue, we have been developing a strategy which utilizes induced pluripotent stem cell (iPSC) technology. This strategy is based on the idea that when iPSCs are produced from antigen-specific CTLs, CTLs regenerated from such iPSCs should show the same antigen specificity as the original CTLs. Pursuing this idea, we previously succeeded in regenerating melanoma antigen MART1-specific CTLs, and more recently in producing potent CTLs expressing CD8αβ heterodimer. We are now developing a novel method by which non-T derived iPSCs are transduced with exogenous T cell receptor genes. If this method is applied to Human Leukocyte Antigen (HLA) haplotype-homozygous iPSC stock, it will be possible to prepare "off-the-shelf" T cells. As a first-in-human trial, we are planning to apply our strategy to relapsed acute myeloid leukemia patients by targeting the WT1 antigen.

Body image and self-esteem in disorders of sex development: A European multicenter study.

PubMed

van de Grift, Tim C; Cohen-Kettenis, Peggy T; de Vries, Annelou L C; Kreukels, Baudewijntje P C

2018-04-01

Disorders/differences of sex development (DSD) refer to congenital conditions with atypical sex development and are associated with psychosexual issues. The aim of this study was to assess body image and self-esteem across the DSD spectrum and to study the impact of diagnosis and mediating characteristics. Data collection was part of dsd-LIFE, a cross-sectional study conducted by 14 European expert clinics on wellbeing and health care evaluation of adults diagnosed with DSD. Main outcome measures in the present analyses were the Body Image Scale and Rosenberg Self-Esteem Scale. Additional data were obtained on treatments, openness, body embarrassment, sexual satisfaction, anxiety, and depression. The participating sample (n = 1,040) included 226 classified as Congenital Adrenal Hyperplasia, 225 as Klinefelter Syndrome, 322 as Turner Syndrome, and 267 as conditions with 46,XY karyotype. Many participants had received hormonal and surgical treatments. Participants scored lower on body image and self-esteem compared to control values, whereas each diagnosis showed different areas of concern. Limited openness, body embarrassment, and sexual issues were frequently reported. Overall body satisfaction was associated with BMI, hormone use, openness, body embarrassment, anxiety, and depression; genital satisfaction with age at diagnosis, openness, sexual satisfaction, and body embarrassment. Body embarrassment, anxiety, and depression predicted lower self-esteem. While each DSD showed specific issues related to body image and self-esteem, our findings indicate that the related factors were similar across the conditions. Clinical care on this subject could be improved by giving specific attention to factors like openness, body embarrassment, sexuality, anxiety, and depression. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

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.

A systematic review of ethical issues in vaccine studies involving pregnant women

PubMed Central

Beeler, Jennifer A.; Lambach, Philipp; Fulton, T. Roice; Narayanan, Divya; Ortiz, Justin R.; Omer, Saad B.

2016-01-01

ABSTRACT Background: Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy. Aims: To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women. Method: We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories. Results: Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs. Conclusion: This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women – offering new and valuable insights for programs developed to prevent disease in newborn children in low- and middle-income countries. PMID:27246403

It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.

PubMed

Ravinetto, Raffaella; Tinto, Halidou; Diro, Ermias; Okebe, Joseph; Mahendradhata, Yodi; Rijal, Suman; Gotuzzo, Eduardo; Lutumba, Pascal; Nahum, Alain; De Nys, Katelijne; Casteels, Minne; Boelaert, Marleen

2016-01-01

The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients' representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time 'global', 'context centred' and 'patient centred'.

'I heard about this study on the radio': using community radio to strengthen Good Participatory Practice in HIV prevention trials.

PubMed

Medeossi, Bonnie-Jeanne; Stadler, Jonathan; Delany-Moretlwe, Sinead

2014-08-26

During the Microbicides Development Program (MDP) 301, a clinical trial of a candidate microbicide amongst women in Johannesburg, South Africa, we used community radio to promote awareness of the trial, to inform community members about specific medical research procedures and terminologies, and to stimulate dialogue between researchers and local citizens. We used mixed methods to undertake a retrospective analysis of the social responses to the radio shows, focusing specifically on recruitment and participation in the MDP301 trial. We collected quantitative data that describes the themes and listener responses, the costs per broadcast, and the impact of the radio broadcasts on trial recruitment. Qualitative data on local reactions to the shows was gleaned from in-depth interviews with trial participants. Over a seven-year period, 205 individual broadcasts were made on two separate community radio stations. Show themes were either specifically related to medical research issues (36%), or focused on general health issues (46%), and sexual and reproductive health, including HIV prevention (18%). 403 listeners made telephone calls to the radio station, and 12% of women enrolled as participants in MDP301 (n = 9, 385) reported that they had first heard about the trial from the radio. Qualitative interviews (n = 401) with female MDP301 participants highlighted the effects of the radio shows in making women aware of the trial, impressing them with the importance of health screening and knowledge, legitimizing trial participation, and stimulating dialogue between trial participants and their male partners. Community radio is a potent tool for raising awareness and local knowledge about medical research and, in addition to other methodologies, can be used to promote recruitment into clinical trials. We suggest that future HIV prevention trials consider an investment in community radio beyond recruitment advertisements that incorporates this into the broader community engagement plan as a key element of Good Participatory Practice in clinical trial settings.

Clinical assessment and crisis intervention for the suicidal bipolar disorder patient.

PubMed

Saunders, Kate E A; Hawton, Keith

2013-08-01

Suicidal behaviour is common in people suffering with bipolar disorder, and suicide is a leading cause of death in this group. Our aim in this review is to provide an overview of key assessment and management strategies, highlight research findings relevant to suicide prevention, and identify important areas for future research. We reviewed the published literature regarding the risk factors for and management of suicida\\l behaviour in individuals with bipolar disorder using the Pubmed and PsychINFO databases. Where available, we focused our search on systematic reviews. Suicide is usually associated with a depressive phase, although mixed affective states also convey increased risk. All individuals with bipolar disorder should have an up-to-date crisis management plan which outlines the action to be taken should suicidal behaviour emerge. Timely clinical assessment is essential in ensuring that those at high risk are identified. This should include mental state examination, consideration of risk factors, and evaluation of issues such as access to means, preparatory acts before suicide, and also protective factors. While pharmacological approaches are the mainstay of management, less specific measures, such as the removal of access to means, are also important in ensuring safety in the acute situation. Intensifying the clinical support of both patients and relatives, and the sharing of risk information with other health agencies are essential in management. Specific psychological treatments are likely to be helpful in preventing crises, although the evidence base is limited. The aetiology of suicidal behaviour in bipolar disorder is multifactorial and requires proactive crisis planning and management. A range of issues need to be addressed in the assessment of at-risk patients. Determining the efficacy of interventions specific to reducing suicidality in bipolar disorder should be a research priority. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Challenges and Developments in the Assessment of (Mal)adaptive Personality and Pathological States in Older Adults.

PubMed

Rossi, Gina; Videler, Arjan; van Alphen, S P J

2018-04-01

Since older adults often show an atypical presentation of (mal)adaptive personality traits and pathological states, the articles in this special issue will concisely discuss some perennial issues in clinical assessment in older adults and thus outline the main challenges this domain faces. By bringing empirical work and meta-analytic studies from leading scholars in the field of geropsychology, the articles will also address these challenges by reporting the latest developments in the field. This way, we hope to reshape the way clinicians and researchers assess (mal)adaptive personality and pathological states in older adults into a more reliable and valid assessment method that integrates the specific biopsychosocial context of older age.

Policy and administrative issues for large-scale clinical interventions following disasters.

PubMed

Scheeringa, Michael S; Cobham, Vanessa E; McDermott, Brett

2014-02-01

Large, programmatic mental health intervention programs for children and adolescents following disasters have become increasingly common; however, little has been written about the key goals and challenges involved. Using available data and the authors' experiences, this article reviews the factors involved in planning and implementing large-scale treatment programs following disasters. These issues include funding, administration, choice of clinical targets, workforce selection, choice of treatment modalities, training, outcome monitoring, and consumer uptake. Ten factors are suggested for choosing among treatment modalities: 1) reach (providing access to the greatest number), 2) retention of patients, 3) privacy, 4) parental involvement, 5) familiarity of the modality to clinicians, 6) intensity (intervention type matches symptom acuity and impairment of patient), 7) burden to the clinician (in terms of time, travel, and inconvenience), 8) cost, 9) technology needs, and 10) effect size. Traditionally, after every new disaster, local leaders who have never done so before have had to be recruited to design, administer, and implement programs. As expertise in all of these areas represents a gap for most local professionals in disaster-affected areas, we propose that a central, nongovernmental agency with national or international scope be created that can consult flexibly with local leaders following disasters on both overarching and specific issues. We propose recommendations and point out areas in greatest need of innovation.

ShopTalk: a pilot study of the feasibility and utility of a therapeutic board game for youth living with cancer

PubMed Central

Wiener, Lori; Battles, Haven; Mamalian, Cynthia; Zadeh, Sima

2016-01-01

Purpose ShopTalk is a therapeutic game, created to help youth living with cancer talk about their illness in a non-threatening way. The aim of this study is to learn how the game is being used in clinical settings and to gather information regarding the usefulness of ShopTalk in establishing a therapeutic relationship and in assessing key psychosocial issues in the child’s life. Methods ShopTalk was distributed at a social work pediatric oncology conference and to 70 sites. Game holders were asked to complete a survey regarding their clinical experience using ShopTalk. Results Responses came from 110 professionals. ShopTalk has been found to be as an effective tool in identifying coping skills and psychological adjustment, as well as issues related to family relationships, depression/sadness, stress, prognosis, peer relationships, and self-esteem. Respondents found ShopTalk useful from diagnosis to end of life. Qualitative feedback suggested therapeutic value along with discomfort with specific questions. Conclusion ShopTalk appears to be a beneficial therapeutic tool in building rapport and identifying and discussing difficult issues with medically ill children. Areas for future versions of the game and research exploring patient/therapist outcomes are discussed PMID:21451945

In-situ medical simulation for pre-implementation testing of clinical service in a regional hospital in Hong Kong.

PubMed

Chen, P P; Tsui, N Tk; Fung, A Sw; Chiu, A Hf; Wong, W Cw; Leong, H T; Lee, P Sf; Lau, J Yw

2017-08-01

The implementation of a new clinical service is associated with anxiety and challenges that may prevent smooth and safe execution of the service. Unexpected issues may not be apparent until the actual clinical service commences. We present a novel approach to test the new clinical setting before actual implementation of our endovascular aortic repair service. In-situ simulation at the new clinical location would enable identification of potential process and system issues prior to implementation of the service. After preliminary planning, a simulation test utilising a case scenario with actual simulation of the entire care process was carried out to identify any logistic, equipment, settings or clinical workflow issues, and to trial a contingency plan for a surgical complication. All patient care including anaesthetic, surgical, and nursing procedures and processes were simulated and tested. Overall, 17 vital process and system issues were identified during the simulation as potential clinical concerns. They included difficult patient positioning, draping pattern, unsatisfactory equipment setup, inadequate critical surgical instruments, blood products logistics, and inadequate nursing support during crisis. In-situ simulation provides an innovative method to identify critical deficiencies and unexpected issues before implementation of a new clinical service. Life-threatening and serious practical issues can be identified and corrected before formal service commences. This article describes our experience with the use of simulation in pre-implementation testing of a clinical process or service. We found the method useful and would recommend it to others.

Patient and healthcare perspectives on the importance and efficacy of addressing spiritual issues within an interdisciplinary bone marrow transplant clinic: a qualitative study

PubMed Central

Sinclair, Shane; McConnell, Shelagh; Raffin Bouchal, Shelley; Ager, Naree; Booker, Reanne; Enns, Bert; Fung, Tak

2015-01-01

Objectives The purpose of this study was to use a qualitative approach to better understand the importance and efficacy of addressing spiritual issues within an interdisciplinary bone marrow transplant clinic from the perspectives of patients and healthcare providers. Setting Participants were recruited from the bone marrow transplant clinic of a large urban outpatient cancer care centre in western Canada. Participants: Focus groups were conducted with patients (n=7) and healthcare providers (n=9) to explore the importance of addressing spiritual issues across the treatment trajectory and to identify factors associated with effectively addressing these needs. Results Data were analysed using the qualitative approach of latent content analysis. Addressing spiritual issues was understood by patients and healthcare providers, as a core, yet under addressed, component of comprehensive care. Both sets of participants felt that addressing basic spiritual issues was the responsibility of all members of the interdisciplinary team, while recognising the need for specialised and embedded support from a spiritual care professional. While healthcare providers felt that the impact of the illness and treatment had a negative effect on patients’ spiritual well-being, patients felt the opposite. Skills, challenges, key time points and clinical indicators associated with addressing spiritual issues were identified. Conclusions Despite a number of conceptual and clinical challenges associated with addressing spiritual issues patients and their healthcare providers emphasised the importance of an integrated approach whereby basic spiritual issues are addressed by members of the interdisciplinary team and by an embedded spiritual care professional, who in addition also provides specialised support. The identification of clinical issues associated with addressing spiritual needs provides healthcare providers with clinical guidance on how to better integrate this aspect of care into their clinical practice, while also identifying acute incidences when a more targeted and specialised approach may be of benefit. PMID:26614623

Guidance from an NIH Workshop on Designing, Implementing, and Reporting Clinical Studies of Soy Interventions1–4

PubMed Central

Klein, Marguerite A.; Nahin, Richard L.; Messina, Mark J.; Rader, Jeanne I.; Thompson, Lilian U.; Badger, Thomas M.; Dwyer, Johanna T.; Kim, Young S.; Pontzer, Carol H.; Starke-Reed, Pamela E.; Weaver, Connie M.

2010-01-01

The NIH sponsored a scientific workshop, “Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies,” July 28–29, 2009. The workshop goal was to provide guidance for the next generation of soy protein/isoflavone human research. Session topics included population exposure to soy; the variability of the human response to soy; product composition; methods, tools, and resources available to estimate exposure and protocol adherence; and analytical methods to assess soy in foods and supplements and analytes in biologic fluids and other tissues. The intent of the workshop was to address the quality of soy studies, not the efficacy or safety of soy. Prior NIH workshops and an evidence-based review questioned the quality of data from human soy studies. If clinical studies are pursued, investigators need to ensure that the experimental designs are optimal and the studies properly executed. The workshop participants identified methodological issues that may confound study results and interpretation. Scientifically sound and useful options for dealing with these issues were discussed. The resulting guidance is presented in this document with a brief rationale. The guidance is specific to soy clinical research and does not address nonsoy-related factors that should also be considered in designing and reporting clinical studies. This guidance may be used by investigators, journal editors, study sponsors, and protocol reviewers for a variety of purposes, including designing and implementing trials, reporting results, and interpreting published epidemiological and clinical studies. PMID:20392880

"I've never asked one question." Understanding the barriers among orthopedic surgery residents to screening female patients for intimate partner violence.

PubMed

Gotlib Conn, Lesley; Young, Aynsely; Rotstein, Ori D; Schemitsch, Emil

2014-12-01

Intimate partner violence (IPV) is a global public health problem. Orthopedic surgery residents may identify IPV among injured patients treated in fracture clinics. Yet, these residents face a number of barriers to recognizing and discussing IPV with patients. We sought to explore orthopedic surgery residents' knowledge of IPV and their preparedness to screen patients for IPV in academic fracture clinic settings with a view to developing targeted IPV education and training. We conducted focus groups with junior and intermediate residents. Discussions explored residents' knowledge of and experiences with IPV screening and preparedness for screening and responding to IPV among orthopedic patients. Data were analyzed iteratively using an inductive approach. Residents were aware of the issue of abuse generally, but had received no specific information or training on IPV in orthopedics. Residents did not see orthopedics faculty screen patients for IPV or advocate for screening. They did not view IPV screening or intervention as part of the orthopedic surgeon's role. Residents' clinical experiences emphasized time management and surgical intervention by effectively "getting through clinic" and "dealing with the surgical problem." Communication with patients about other health issues was minimal or nonexistent. Orthopedic surgery residents are entering a career path where IPV is well documented. They encounter cultural and structural barriers preventing the incorporation of IPV screening into their clinical and educational experiences. Hospitals and academic programs must collaborate in efforts to build capacity for sustainable IPV screening programs among these trainees.

Robust inference for responder analysis: Innovative clinical trial design using a minimum p-value approach.

PubMed

Lin, Yunzhi

2016-08-15

Responder analysis is in common use in clinical trials, and has been described and endorsed in regulatory guidance documents, especially in trials where "soft" clinical endpoints such as rating scales are used. The procedure is useful, because responder rates can be understood more intuitively than a difference in means of rating scales. However, two major issues arise: 1) such dichotomized outcomes are inefficient in terms of using the information available and can seriously reduce the power of the study; and 2) the results of clinical trials depend considerably on the response cutoff chosen, yet in many disease areas there is no consensus as to what is the most appropriate cutoff. This article addresses these two issues, offering a novel approach for responder analysis that could both improve the power of responder analysis and explore different responder cutoffs if an agreed-upon common cutoff is not present. Specifically, we propose a statistically rigorous clinical trial design that pre-specifies multiple tests of responder rates between treatment groups based on a range of pre-specified responder cutoffs, and uses the minimum of the p-values for formal inference. The critical value for hypothesis testing comes from permutation distributions. Simulation studies are carried out to examine the finite sample performance of the proposed method. We demonstrate that the new method substantially improves the power of responder analysis, and in certain cases, yields power that is approaching the analysis using the original continuous (or ordinal) measure.

Issues in recruiting community-dwelling stroke survivors to clinical trials: the AMBULATE trial.

PubMed

Lloyd, Gemma; Dean, Catherine M; Ada, Louise

2010-07-01

Recruitment to clinical trials is often slow and difficult, with a growing body of research examining this issue. However there is very little work related to stroke. The aim of this study was to examine the success and efficiency of recruitment of community-dwelling stroke survivors over the first two years of a clinical trial aiming to improve community ambulation. Recruitment strategies fell into 2 broad categories: (i) advertisement (such as newspaper advertising and media releases), and (ii) referral (via hospital and community physiotherapists, a stroke liaison officer and other researchers). Records were kept of the number of people who were screened, were eligible and were recruited for each strategy. The recruitment target of 60 in the first two years was not met. 111 stroke survivors were screened and 57 were recruited (i.e., a recruitment rate of 51%). The most successful strategy was referral via hospital-based physiotherapists (47% of recruited participants) and the least successful were media release and local newspaper advertising. The referral strategies were all more efficient than any of the advertisement strategies. In general, recruitment was inefficient and costly in terms of human resources. Given that stroke research is underfunded, it is important to find efficient ways of recruiting stroke survivors to clinical trials. An Australian national database similar to other disease-specific data bases (such as the National Cancer Database) is under development. In the interim, recruiting for several clinical trials at once may increase efficiency.

Free radicals in ischemic and reperfusion myocardial injury: is this the time for clinical trials?

PubMed

Cohen, M V

1989-12-01

An increasing number of studies in cell cultures, isolated perfused hearts, and intact animal preparations purport to show the significance of free radical production in the pathophysiology of myocardial injury and necrosis of ischemic and reoxygenated or reperfused tissue. Additionally an impressive array of therapeutic approaches has been developed to interfere with the generation of free radicals and to thereby salvage jeopardized myocardium. Based on these data clinical trials are now being conducted or planned. However, a critical examination of the experimental data raises questions that undermine total acceptance of the conclusions of the investigators and the enthusiastic extrapolations to the clinical arena. Issues such as endotoxin contamination of infused free radical scavenger enzymes, incorrect dosing, possibly improper selection of control conditions, species specificity, inadequate consideration of the dependence of infarct size on coronary collateral blood flow, and the possibly transient nature of any benefits of anti-free radical interventions cast doubt on some of the accumulated data and their general applicability to humans. These issues must be satisfactorily addressed before this experimental approach can be fully embraced by the clinical cardiologist. Additionally, uniformity in the experimental model and conditions might eliminate some of the confusion and make it easier to compare the results of different studies. Free radical mechanisms may be important in the heart, but more data are needed to rigorously document an unequivocal effect of therapeutic interventions in experimental models before clinical trials are appropriate.

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.

A concept analysis of voluntary active euthanasia.

PubMed

Guo, Fenglin

2006-01-01

Euthanasia has a wide range of classifications. Confusion exists in the application of specific concepts to various studies. To analyze the concept of voluntary active euthanasia using Walker and Avant's concept analysis method. A comprehensive literature review from various published literature and bibliographies. Clinical, ethical, and policy differences and similarities of euthanasia need to be debated openly, both within the medical profession and publicly. Awareness of the classifications about euthanasia may help nurses dealing with "end of life issues" properly.

Neuroscientists' everyday experiences of ethics: the interplay of regulatory, professional, personal and tangible ethical spheres.

PubMed

Brosnan, Caragh; Cribb, Alan; Wainwright, Steven P; Williams, Clare

2013-11-01

The ethical issues neuroscience raises are subject to increasing attention, exemplified in the emergence of the discipline neuroethics. While the moral implications of neurotechnological developments are often discussed, less is known about how ethics intersects with everyday work in neuroscience and how scientists themselves perceive the ethics of their research. Drawing on observation and interviews with members of one UK group conducting neuroscience research at both the laboratory bench and in the clinic, this article examines what ethics meant to these researchers and delineates four specific types of ethics that shaped their day-to-day work: regulatory, professional, personal and tangible. While the first three categories are similar to those identified elsewhere in sociological work on scientific and clinical ethics, the notion of 'tangible ethics' emerged by attending to everyday practice, in which these scientists' discursive distinctions between right and wrong were sometimes challenged. The findings shed light on how ethical positions produce and are, in turn, produced by scientific practice. Informing sociological understandings of neuroscience, they also throw the category of neuroscience and its ethical specificity into question, given that members of this group did not experience their work as raising issues that were distinctly neuro-ethical. © 2013 The Authors. Sociology of Health & Illness © 2013 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

Building new hospitals: a UK infection control perspective.

PubMed

Stockley, J M; Constantine, C E; Orr, K E

2006-03-01

Infection control input is vital throughout the planning, design and building stages of a new hospital project, and must continue through the commissioning (and decommissioning) process, evaluation and putting the facility into full clinical service. Many hospitals continue to experience problems months or years after occupying the new premises; some of these could have been avoided by infection control involvement earlier in the project. The importance of infection control must be recognized by the chief executive of the hospital trust and project teams overseeing the development. Clinical user groups and contractors must also be made aware of infection control issues. It is vital that good working relationships are built up between the infection control team (ICT) and all these parties. ICTs need the authority to influence the process. This may require their specific recognition by the Private Finance Initiative National Unit, the Department of Health or other relevant authorities. ICTs need training in how to read design plans, how to write effective specifications, and in other areas with which they may be unfamiliar. The importance of documentation and record keeping is paramount. External or independent validation of processes should be available, particularly in commissioning processes. Building design in relation to infection control needs stricter national regulations, allowing ICTs to focus on more local usage issues. Further research is needed to provide evidence regarding the relationship between building design and the prevalence of infection.

(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization.

PubMed

Vallabhajosula, Shankar

2007-11-01

Molecular imaging is the visualization, characterization, and measurement of biological processes at the molecular and cellular levels in a living system. At present, positron emission tomography/computed tomography (PET/CT) is one the most rapidly growing areas of medical imaging, with many applications in the clinical management of patients with cancer. Although [(18)F]fluorodeoxyglucose (FDG)-PET/CT imaging provides high specificity and sensitivity in several kinds of cancer and has many applications, it is important to recognize that FDG is not a "specific" radiotracer for imaging malignant disease. Highly "tumor-specific" and "tumor cell signal-specific" PET radiopharmaceuticals are essential to meet the growing demand of radioisotope-based molecular imaging technology. In the last 15 years, many alternative PET tracers have been proposed and evaluated in preclinical and clinical studies to characterize the tumor biology more appropriately. The potential clinical utility of several (18)F-labeled radiotracers (eg, fluoride, FDOPA, FLT, FMISO, FES, and FCH) is being reviewed by several investigators in this issue. An overview of design and development of (18)F-labeled PET radiopharmaceuticals, radiochemistry, and mechanism(s) of tumor cell uptake and localization of radiotracers are presented here. The approval of clinical indications for FDG-PET in the year 2000 by the Food and Drug Administration, based on a review of literature, was a major breakthrough to the rapid incorporation of PET into nuclear medicine practice, particularly in oncology. Approval of a radiopharmaceutical typically involves submission of a "New Drug Application" by a manufacturer or a company clearly documenting 2 major aspects of the drug: (1) manufacturing of PET drug using current good manufacturing practices and (2) the safety and effectiveness of a drug with specific indications. The potential routine clinical utility of (18)F-labeled PET radiopharmaceuticals depends also on regulatory compliance in addition to documentation of potential safety and efficacy by various investigators.

Practical Guidelines: Lung Transplantation in Patients with Cystic Fibrosis

PubMed Central

Hirche, T. O.; Knoop, C.; Hebestreit, H.; Shimmin, D.; Solé, A.; Elborn, J. S.; Ellemunter, H.; Aurora, P.; Hogardt, M.; Wagner, T. O. F.; ECORN-CF Study Group

2014-01-01

There are no European recommendations on issues specifically related to lung transplantation (LTX) in cystic fibrosis (CF). The main goal of this paper is to provide CF care team members with clinically relevant CF-specific information on all aspects of LTX, highlighting areas of consensus and controversy throughout Europe. Bilateral lung transplantation has been shown to be an important therapeutic option for end-stage CF pulmonary disease. Transplant function and patient survival after transplantation are better than in most other indications for this procedure. Attention though has to be paid to pretransplant morbidity, time for referral, evaluation, indication, and contraindication in children and in adults. This review makes extensive use of specific evidence in the field of lung transplantation in CF patients and addresses all issues of practical importance. The requirements of pre-, peri-, and postoperative management are discussed in detail including bridging to transplant and postoperative complications, immune suppression, chronic allograft dysfunction, infection, and malignancies being the most important. Among the contributors to this guiding information are 19 members of the ECORN-CF project and other experts. The document is endorsed by the European Cystic Fibrosis Society and sponsored by the Christiane Herzog Foundation. PMID:24800072

Accessing and Integrating Data and Knowledge for Biomedical Research

PubMed Central

Burgun, A.; Bodenreider, O.

2008-01-01

Summary Objectives To review the issues that have arisen with the advent of translational research in terms of integration of data and knowledge, and survey current efforts to address these issues. Methods Using examples form the biomedical literature, we identified new trends in biomedical research and their impact on bioinformatics. We analyzed the requirements for effective knowledge repositories and studied issues in the integration of biomedical knowledge. Results New diagnostic and therapeutic approaches based on gene expression patterns have brought about new issues in the statistical analysis of data, and new workflows are needed are needed to support translational research. Interoperable data repositories based on standard annotations, infrastructures and services are needed to support the pooling and meta-analysis of data, as well as their comparison to earlier experiments. High-quality, integrated ontologies and knowledge bases serve as a source of prior knowledge used in combination with traditional data mining techniques and contribute to the development of more effective data analysis strategies. Conclusion As biomedical research evolves from traditional clinical and biological investigations towards omics sciences and translational research, specific needs have emerged, including integrating data collected in research studies with patient clinical data, linking omics knowledge with medical knowledge, modeling the molecular basis of diseases, and developing tools that support in-depth analysis of research data. As such, translational research illustrates the need to bridge the gap between bioinformatics and medical informatics, and opens new avenues for biomedical informatics research. PMID:18660883

Getting Ready for Inspection of Investigational Site at Short Notice

PubMed Central

Talele, Rajendra

2010-01-01

India is becoming an attractive destination for drug development and clinical research. This is evidenced by the three fold increment in clinical trial applications in last four years to the office of Drugs Controller General of India (DCGI). This upward trend is collaborative efforts of all stake holders and the quality of Indian data. Therefore to sustain this trend, it is important that stake holders such as Regulators, Sponsor, CRO, Monitor, Investigators and trial subjects required maintaining high standards of data and conduct of clinical trials. Indian regulations and the role of DCGI in quality check for Indian clinical trials is always a topic of discussion in various forums. A recent move by DCGI for conducting random inspections of investigational sites and companies at short notice, checking their compliance in accordance with the guidelines, and taking action against non-complier is welcomed. This will certainly increase over quality of the clinical trials. Quality of clinical trial conduct is measured on essential documents for their appropriateness and its correctness. It is observed that the stakeholders engaged in multitasking often overlook the requirements or appropriateness of the document due to their focused approach on a specific activity which is on priority. This can lead to serious quality problem and issues. Understanding of the process and documents reviewed by auditor is important to maintain such high quality. The proper planning and time management working on essential documents can minimize the quality issues, and we can be always ready for any type of inspection, announced or unannounced, or “short notice”. PMID:21829785

Opportunity to discuss ethical issues during clinical learning experience.

PubMed

Palese, Alvisa; Gonella, Silvia; Destrebecq, Anne; Mansutti, Irene; Terzoni, Stefano; Morsanutto, Michela; Altini, Pietro; Bevilacqua, Anita; Brugnolli, Anna; Canzan, Federica; Ponte, Adriana Dal; De Biasio, Laura; Fascì, Adriana; Grosso, Silvia; Mantovan, Franco; Marognolli, Oliva; Nicotera, Raffaela; Randon, Giulia; Tollini, Morena; Saiani, Luisa; Grassetti, Luca; Dimonte, Valerio

2018-01-01

Undergraduate nursing students have been documented to experience ethical distress during their clinical training and felt poorly supported in discussing the ethical issues they encountered. Research aims: This study was aimed at exploring nursing students' perceived opportunity to discuss ethical issues that emerged during their clinical learning experience and associated factors. An Italian national cross-sectional study design was performed in 2015-2016. Participants were invited to answer a questionnaire composed of four sections regarding: (1) socio-demographic data, (2) previous clinical learning experiences, (3) current clinical learning experience quality and outcomes, and (4) the opportunity to discuss ethical issues with nurses in the last clinical learning experience (from 0 - 'never' to 3 - 'very much'). Participants and research context: Participants were 9607 undergraduate nursing students who were attending 95 different three-year Italian baccalaureate nursing programmes, located at 27 universities in 15 Italian regions. Ethical considerations: This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines after the research protocol was approved by an ethics committee. Overall, 4707 (49%) perceived to have discussed ethical issues 'much' or 'very much'; among the remaining, 3683 (38.3%) and 1217 (12.7%) students reported the perception of having discussed, respectively, 'enough' or 'never' ethical issues emerged in the clinical practice. At the multivariate logistic regression analysis explaining 38.1% of the overall variance, the factors promoting ethical discussion were mainly set at the clinical learning environment levels (i.e. increased learning opportunities, self-directed learning, safety and nursing care quality, quality of the tutorial strategies, competences learned and supervision by a clinical nurse). In contrast, being male was associated with a perception of less opportunity to discuss ethical issues. Nursing faculties should assess the clinical environment prerequisites of the settings as a context of student experience before deciding on their accreditation. Moreover, the nursing faculty and nurse managers should also enhance competence with regard to discussing ethical issues with students among clinical nurses by identifying factors that hinder this learning opportunity in daily practice.

Adoptive immunotherapy for acute leukemia: New insights in chimeric antigen receptors

PubMed Central

Heiblig, Maël; Elhamri, Mohamed; Michallet, Mauricette; Thomas, Xavier

2015-01-01

Relapses remain a major concern in acute leukemia. It is well known that leukemia stem cells (LSCs) hide in hematopoietic niches and escape to the immune system surveillance through the outgrowth of poorly immunogenic tumor-cell variants and the suppression of the active immune response. Despite the introduction of new reagents and new therapeutic approaches, no treatment strategies have been able to definitively eradicate LSCs. However, recent adoptive immunotherapy in cancer is expected to revolutionize our way to fight against this disease, by redirecting the immune system in order to eliminate relapse issues. Initially described at the onset of the 90’s, chimeric antigen receptors (CARs) are recombinant receptors transferred in various T cell subsets, providing specific antigens binding in a non-major histocompatibility complex restricted manner, and effective on a large variety of human leukocyte antigen-divers cell populations. Once transferred, engineered T cells act like an expanding “living drug” specifically targeting the tumor-associated antigen, and ensure long-term anti-tumor memory. Over the last decades, substantial improvements have been made in CARs design. CAR T cells have finally reached the clinical practice and first clinical trials have shown promising results. In acute lymphoblastic leukemia, high rate of complete and prolonged clinical responses have been observed after anti-CD19 CAR T cell therapy, with specific but manageable adverse events. In this review, our goal was to describe CAR structures and functions, and to summarize recent data regarding pre-clinical studies and clinical trials in acute leukemia. PMID:26328018

The importance of semen analysis in the context of azoospermia.

PubMed

Aziz, Nabil

2013-01-01

Azoospermia is a descriptive term referring to ejaculates that lack spermatozoa without implying a specific underlying cause. The traditional definition of azoospermia is ambiguous, which has ramifications on the diagnostic criteria. This issue is further compounded by the apparent overlap between the definitions of oligospermia and azoospermia. The reliable diagnosis of the absence of spermatozoa in a semen sample is an important criterion not only for diagnosing male infertility but also for ascertaining the success of a vasectomy and for determining the efficacy of hormonal contraception. There appears to be different levels of rigor in diagnosing azoospermia in different clinical situations, which highlights the conflict between scientific research and clinical practice in defining azoospermia.

Advances in Non-Viral DNA Vectors for Gene Therapy

PubMed Central

Hardee, Cinnamon L.; Arévalo-Soliz, Lirio Milenka; Hornstein, Benjamin D.; Zechiedrich, Lynn

2017-01-01

Uses of viral vectors have thus far eclipsed uses of non-viral vectors for gene therapy delivery in the clinic. Viral vectors, however, have certain issues involving genome integration, the inability to be delivered repeatedly, and possible host rejection. Fortunately, development of non-viral DNA vectors has progressed steadily, especially in plasmid vector length reduction, now allowing these tools to fill in specifically where viral or other non-viral vectors may not be the best options. In this review, we examine the improvements made to non-viral DNA gene therapy vectors, highlight opportunities for their further development, address therapeutic needs for which their use is the logical choice, and discuss their future expansion into the clinic. PMID:28208635

Critical thinking about adverse drug effects: lessons from the psychology of risk and medical decision-making for clinical psychopharmacology.

PubMed

Nierenberg, Andrew A; Smoller, Jordan W; Eidelman, Polina; Wu, Yelena P; Tilley, Claire A

2008-01-01

Systematic biases in decision-making have been well characterized in medical and nonmedical fields but mostly ignored in clinical psychopharmacology. The purpose of this paper is to sensitize clinicians who prescribe psychiatric drugs to the issues of the psychology of risk, especially as they pertain to the risk of side effects. Specifically, the present analysis focuses on heuristic organization and framing effects that create cognitive biases in medical practice. Our purpose is to increase the awareness of how pharmaceutical companies may influence physicians by framing the risk of medication side effects to favor their products. (c) 2008 S. Karger AG, Basel.

Management of hypertension in the elderly: Looking for a trade-off between cardiovascular prevention and serious adverse events.

PubMed

Buonacera, Agata; Stancanelli, Benedetta; Malatino, Lorenzo

2018-06-07

Despite the effectiveness of anti-hypertensive therapy is well recognized, the most adequate target to achieve in the management of hypertension in the elderly is still under debate. Indeed, looking at the balance between benefits and risks, accumulating evidence has recently specifically addressed this issue, focusing on controversies. Evidence surrounding a more aggressive treatment may lead to a turnaround in the clinical care of older adult hypertensives, but a balanced trade-off between benefits and risks needs to be programmed and achieved, particularly in this clinical setting. We argue whether and how the results from recent trials could influence the management of hypertension in older people.

Periodontology: past, present, perspectives.

PubMed

Slots, Jørgen

2013-06-01

Periodontitis is an infectious disease that affects the tooth-supporting tissues and exhibits a wide range of clinical, microbiological and immunological manifestations. The disease is associated with and is probably caused by a multifaceted dynamic interaction of specific infectious agents, host immune responses, harmful environmental exposure and genetic susceptibility factors. This volume of Periodontology 2000 covers key subdisciplines of periodontology, ranging from etiopathogeny to therapy, with emphasis on diagnosis, classification, epidemiology, risk factors, microbiology, immunology, systemic complications, anti-infective therapy, reparative treatment, self-care and affordability issues. Learned and unlearned concepts of periodontitis over the past 50 years have shaped our current understanding of the etiology of the disease and of clinical practice. © 2013 John Wiley & Sons A/S.

Obesity and inflammatory arthritis: impact on occurrence, disease characteristics and therapeutic response

PubMed Central

Daïen, Claire I; Sellam, Jérémie

2015-01-01

Overweight and obesity are increasing worldwide and now reach about one-third of the world's population. Obesity also involves patients with inflammatory arthritis. Knowing the impact of obesity on rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis) is thus an important issue. This article first reviews the epidemiological and clinical data available on obesity in inflammatory rheumatic diseases, that is, its impact on incident disease, disease characteristics and the therapeutic response. The second part of this review gives an overview of the factors potentially involved in the specifics of inflammatory arthritis in patients with obesity, such as limitations in the clinical assessment, diet, microbiota and adipokines. PMID:26509048

Polyunsaturated fatty acids (PUFAs) for children with specific learning disorders.

PubMed

Tan, May Loong; Ho, Jacqueline J; Teh, Keng Hwang

2012-12-12

About 5% of schoolchildren have a specific learning disorder, defined as an unexpected failure to acquire adequate abilities in reading, writing or mathematic skills not as a result of reduced intellectual ability, inadequate teaching or social deprivation. Of these, 80% are reading disorders. Polyunsaturated fatty acids (PUFAs), in particular omega-3 and omega-6 fatty acids, which are found abundantly in the brain and retina are important for learning. Some children with specific learning disorders have been found to be deficient in these PUFAs, and it is argued that supplementation of PUFAs may help these children improve their learning abilities. To assess the effects of polyunsaturated fatty acids (PUFAs) supplementation for children with specific learning disorders, on learning outcomes. We searched the following databases in April 2012: CENTRAL (2012, Issue 4), MEDLINE (1948 to April Week 2 2012), EMBASE (1980 to 2012 Week 16), PsycINFO (1806 to April 2012), ERIC (1966 to April 2012), Science Citation Index (1970 to 20 April 2012), Social Science Citation Index (1970 to 20 April 2012), Conference Proceedings Citation Index-Science (1970 to 20 April 2012), Conference Proceedings Citation Index-Social Sciences and Humanites (1970 to 20 April 2012), Cochrane Database of Systematic Reviews (2012, Issue 4), DARE (2012, Issue 2) , ZETOC (24 April 2012) and WorldCat (24 April 2012). We searched the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov on 24 April 2012. We also searched the reference lists of relevant articles identified by the searches. Randomised or quasi-randomised controlled trials comparing polyunsaturated fatty acids (PUFAs) with placebo or no treatment in children aged below 18 years with specific learning disabilities diagnosed using DSM-IV, ICD-10 or equivalent criteria. We intended to include participants with co-existing developmental disorders such as attention deficit hyperactivity disorder (ADHD) or autism. Two authors (ML and KH) independently screened the titles and abstracts of the search results and eliminated all studies that did not meet the inclusion criteria. Authors were contacted for missing information and clarifications when needed. We did not find any studies suitable for inclusion in the review. One study is awaiting classification as we were unable to get any information from the study author. There is insufficient evidence to draw any conclusion about the use of PUFAs for children with specific learning disorders. There is a need for well designed randomised studies to support or refute the use of PUFAs in this group of children.

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

Oral Anticoagulant Therapy

PubMed Central

Gallus, Alexander S.; Wittkowsky, Ann; Crowther, Mark; Hylek, Elaine M.; Palareti, Gualtiero

2012-01-01

Background: The objective of this article is to summarize the published literature concerning the pharmacokinetics and pharmacodynamics of oral anticoagulant drugs that are currently available for clinical use and other aspects related to their management. Methods: We carried out a standard review of published articles focusing on the laboratory and clinical characteristics of the vitamin K antagonists; the direct thrombin inhibitor, dabigatran etexilate; and the direct factor Xa inhibitor, rivaroxaban Results: The antithrombotic effect of each oral anticoagulant drug, the interactions, and the monitoring of anticoagulation intensity are described in detail and discussed without providing specific recommendations. Moreover, we describe and discuss the clinical applications and optimal dosages of oral anticoagulant therapies, practical issues related to their initiation and monitoring, adverse events such as bleeding and other potential side effects, and available strategies for reversal. Conclusions: There is a large amount of evidence on laboratory and clinical characteristics of vitamin K antagonists. A growing body of evidence is becoming available on the first new oral anticoagulant drugs available for clinical use, dabigatran and rivaroxaban. PMID:22315269

Clinical Mass Spectrometry: Achieving Prominence in Laboratory Medicine

DOE Office of Scientific and Technical Information (OSTI.GOV)

Annesley, Thomas M.; Cooks, Robert G.; Herold, David A.

Each year the journal Clinical Chemistry publishes a January special issue on a topic that is relevant to the laboratory medicine community. In January 2016 the topic is mass spectrometry, and the issue is entitled “Clinical Mass Spectrometry: Achieving Prominence in Laboratory Medicine”. One popular feature in our issues is a Q&A on a topic, clearly in this case mass spectrometry. The journal is assembling a panel of 5-6 experts from various areas of mass spectrometry ranging from instrument manufacturing to practicing clinical chemists. Dick Smith is one of the scientist requested to participate in this special issue Q&A onmore » Mass Spectrometry. The Q&A Transcript is attached« less

Ethical issues in medical research in the developing world: a report on a meeting organised by Fondation Mérieux.

PubMed

Perrey, Christophe; Wassenaar, Douglas; Gilchrist, Shawn; Ivanoff, Bernard

2009-08-01

This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future. Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged.

CaP CURE Initiatives and Projects

PubMed Central

Soule, Howard R

2003-01-01

CaP CURE was founded in 1993 to help find better treatments and a cure for prostate cancer. By reducing the time and complexity required to apply for funding, and by funding many first-time applicants, CaP CURE has attracted a large number of high-level investigators to the field of prostate cancer research. The organization’s Therapy Consortium meets regularly to address major issues that impede progress in clinical development of new treatments for prostate cancer. CaP CURE has also sponsored an initiative to standardize clinical trial design scenarios for the clinical state of rising prostate-specific antigen and intends to present them to the Food and Drug Administration in partnership with the National Dialogue on Cancer. Finally, CaP CURE’s efforts have resulted in a significant increase in federal funding of prostate cancer research programs. PMID:16986049

Future directions for cardiovascular disease comparative effectiveness research: report of a workshop sponsored by the National Heart, Lung, and Blood Institute.

PubMed

Hlatky, Mark A; Douglas, Pamela S; Cook, Nakela L; Wells, Barbara; Benjamin, Emelia J; Dickersin, Kay; Goff, David C; Hirsch, Alan T; Hylek, Elaine M; Peterson, Eric D; Roger, Véronique L; Selby, Joseph V; Udelson, James E; Lauer, Michael S

2012-08-14

Comparative effectiveness research (CER) aims to provide decision makers with the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart, Lung, and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address 8 clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Adjunctive use of the diode laser in non-surgical periodontal therapy: exploring the controversy.

PubMed

Porteous, Mary Sornborger; Rowe, Dorothy J

2014-04-01

Despite the controversy regarding clinical efficacy, dental hygienists use the diode laser as an adjunct to non-surgical periodontal therapy. The technique to maximize successful laser therapy outcome is controversial as well. The purpose of this review is to explore the scientific foundation of the controversy surrounding the use of the diode laser as an adjunct to non-surgical periodontal therapy. Further, this paper addresses the weaknesses in study design, the heterogeneity of methodology in the published clinical studies, especially the laser parameters, and how these issues impact the collective clinical and microbial data, and thus conclusions regarding clinical efficacy. Evaluation of the literature identifies possible mechanisms that could contribute to the varied, often conflicting results among laser studies that are the foundation of the controversy surrounding clinical efficacy. These mechanisms include current paradigms of periodontal biofilm behavior, tissue response to laser therapy being dependent on tissue type and health, and that the successful therapeutic treatment window is specific to the target tissue, biofilm composition, laser wavelength, and laser energy delivered. Lastly, this paper discusses laser parameters used in the various clinical studies, and how their diversity contributes to the controversy. Although this review does not establish clinical efficacy, it does reveal the scientific foundation of the controversy and the need for standardized, well designed randomized controlled clinical trials to develop specific guidelines for using the laser as an adjunct to non-surgical periodontal therapy. Using evidence-based laser guidelines would allow dental hygienists to provide more effective non-surgical periodontal care.

Meta-Analyses and Orthodontic Evidence-Based Clinical Practice in the 21st Century

PubMed Central

Papadopoulos, Moschos A.

2010-01-01

Introduction: Aim of this systematic review was to assess the orthodontic related issues which currently provide the best evidence as documented by meta-analyses, by critically evaluating and discussing the methodology used in these studies. Material and Methods: Several electronic databases were searched and handsearching was also performed in order to identify the corresponding meta-analyses investigating orthodontic related subjects. In total, 197 studies were retrieved initially. After applying specific inclusion and exclusion criteria, 27 articles were identified as meta-analyses treating orthodontic-related subjects. Results: Many of these 27 papers presented sufficient quality and followed appropriate meta-analytic approaches to quantitatively synthesize data and presented adequately supported evidence. However, the methodology used in some of them presented weaknesses, limitations or deficiencies. Consequently, the topics in orthodontics which currently provide the best evidence, include some issues related to Class II or Class III treatment, treatment of transverse problems, external apical root resorption, dental anomalies, such as congenital missing teeth and tooth transposition, frequency of severe occlusal problems, nickel hypersensitivity, obstructive sleep apnea syndrome, and computer-assisted learning in orthodontic education. Conclusions: Only a few orthodontic related issues have been so far investigated by means of MAs. In addition, for some of these issues investigated in the corresponding MAs no definite conclusions could be drawn, due to significant methodological deficiencies of these studies. According to this investigation, it can be concluded that at the begin of the 21st century there is evidence for only a few orthodontic related issues as documented by meta-analyses, and more well-conducted high quality research studies are needed to produce strong evidence in order to support evidence-based clinical practice in orthodontics. PMID:21673839

Science and ethics of human immunodeficiency virus/acquired immunodeficiency syndrome controversies in Africa.

PubMed

Brewster, David

2011-09-01

The human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic in Africa has raised important ethical issues for both researchers and clinicians. The most notorious controversy has been related to the zidovudine (AZT) trials in Africa in the late 1990s, in which the control groups were given a placebo rather than an effective drug to prevent vertical transmission. This raised concerns in the sponsoring country about exploitation of subjects, injustice and an ethical double standard between donor countries and resource-poor settings. However, the real double standard is between clinical practice standards in Western versus African countries, which must be addressed as part of the increasing global inequity of wealth both between countries and also within countries. There are important limitations to ethical declarations, principles and guidelines on their own without contextual ethical reasoning. The focus on research ethics with the HIV epidemic has led to a relative neglect of ethical issues in clinical practice. Although the scientific advances in HIV/AIDS have changed the ethical issues since the 1990s, there has also been progress in the bioethics of HIV/AIDS in terms of ethical review capability by local committees as well as in exposure to ethical issues by clinicians and researchers in Africa. However, serious concerns remain about the overregulation of research by bureaucratic agencies which could discourage African research on specifically African health issues. There is also a need for African academic institutions and researchers to progressively improve their research capacity with the assistance of research funders and donor agencies. © 2011 The Author. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Did I Tell You That? Ethical Issues Related to Using Computational Methods to Discover Non-Disclosed Patient Characteristics

PubMed Central

Cato, Kenrick D; Bockting, Walter; Larson, Elaine

2016-01-01

Background Widespread availability of large data sets through warehousing of electronic health records coupled with increasingly sophisticated information technology and related statistical methods offer great potential for a variety of applications for health and disease surveillance, developing predictive models and advancing decision support for clinicians. However, use of such ‘big data’ mining and discovery techniques has also raised ethical issues such as how to balance privacy and autonomy with the wider public benefits of data sharing. More specifically, electronic data are being increasingly used to identify individual characteristics which can be useful for clinical prediction and management, but that were not previously disclosed to a clinician. This process in computer parlance is called electronic phenotyping, and has a number of ethical implications. Approach Using the Belmont Report’s principles of respect for persons, beneficence, and justice as a framework, we examined the ethical issues posed by electronic phenotyping. Findings Ethical issues identified include the ability of the patient to consent for the use of their information, the ability to suppress pediatric information, ensuring that the potential benefits justify the risks of harm to patients, and acknowledging that the clinician’s biases or stereotypes, conscious or unintended, may also become a factor in the therapeutic interaction. We illustrate these issues with two vignettes, using the person characteristic of gender minority status (i.e., transgender identity) and the health history characteristic of substance abuse. Conclusion Big data mining has the potential to uncover patient characteristics previously obscured which can provide clinicians with beneficial clinical information. Hence, ethical guidelines must be updated to ensure that electronic phenotyping supports the principles of respect for persons, beneficence, and justice. PMID:27534587

Strategies and methods to study female-specific cardiovascular health and disease: a guide for clinical scientists.

PubMed

Ouyang, Pamela; Wenger, Nanette K; Taylor, Doris; Rich-Edwards, Janet W; Steiner, Meir; Shaw, Leslee J; Berga, Sarah L; Miller, Virginia M; Merz, Noel Bairey

2016-01-01

In 2001, the Institute of Medicine's (IOM) report, "Exploring the Biological Contributions to Human Health: Does Sex Matter?" advocated for better understanding of the differences in human diseases between the sexes, with translation of these differences into clinical practice. Sex differences are well documented in the prevalence of cardiovascular (CV) risk factors, the clinical manifestation and incidence of cardiovascular disease (CVD), and the impact of risk factors on outcomes. There are also physiologic and psychosocial factors unique to women that may affect CVD risk, such as issues related to reproduction. The Society for Women's Health Research (SWHR) CV Network compiled an inventory of sex-specific strategies and methods for the study of women and CV health and disease across the lifespan. References for methods and strategy details are provided to gather and evaluate this information. Some items comprise robust measures; others are in development. To address female-specific CV health and disease in population, physiology, and clinical trial research, data should be collected on reproductive history, psychosocial variables, and other factors that disproportionately affect CVD in women. Variables related to reproductive health include the following: age of menarche, menstrual cycle regularity, hormone levels, oral contraceptive use, pregnancy history/complications, polycystic ovary syndrome (PCOS) components, menopause age, and use and type of menopausal hormone therapy. Other factors that differentially affect women's CV risk include diabetes mellitus, autoimmune inflammatory disease, and autonomic vasomotor control. Sex differences in aging as well as psychosocial variables such as depression and stress should also be considered. Women are frequently not included/enrolled in mixed-sex CVD studies; when they are included, information on these variables is generally not collected. These omissions limit the ability to determine the role of sex-specific contributors to CV health and disease. Lack of sex-specific knowledge contributes to the CVD health disparities that women face. The purpose of this review is to encourage investigators to consider ways to increase the usefulness of physiological and psychosocial data obtained from clinical populations, in an effort to improve the understanding of sex differences in clinical CVD research and health-care delivery for women and men.

Feasibility of energy medicine in a community teaching hospital: an exploratory case series.

PubMed

Dufresne, Francois; Simmons, Bonnie; Vlachostergios, Panagiotis J; Fleischner, Zachary; Joudeh, Ramsey; Blakeway, Jill; Julliard, Kell

2015-06-01

Energy medicine (EM) derives from the theory that a subtle biologic energy can be influenced for therapeutic effect. EM practitioners may be trained within a specific tradition or work solo. Few studies have investigated the feasibility of solo-practitioner EM in hospitals. This study investigated the feasibility of EM as provided by a solo practitioner in inpatient and emergent settings. Feasibility study, including a prospective case series. Inpatient units and emergency department. To investigate the feasibility of EM, acceptability, demand, implementation, and practicality were assessed. Short-term clinical changes were documented by treating physicians. Patients, employees, and family members were enrolled in the study only if study physicians expected no or slow improvement in specific symptoms. Those with secondary gains or who could not communicate perception of symptom change were excluded. EM was found to have acceptability and demand, and implementation was smooth because study procedures dovetailed with conventional clinical practice. Practicality was acceptable within the study but was low upon further application of EM because of cost of program administration. Twenty-four of 32 patients requested relief from pain. Of 50 reports of pain, 5 (10%) showed no improvement; 4 (8%), slight improvement; 3 (6%), moderate improvement; and 38 (76%), marked improvement. Twenty-one patients had issues other than pain. Of 29 non-pain-related problems, 3 (10%) showed no, 2 (7%) showed slight, 1 (4%) showed moderate, and 23 (79%) showed marked improvement. Changes during EM sessions were usually immediate. This study successfully implemented EM provided by a solo practitioner in inpatient and emergent hospital settings and found that acceptability and demand justified its presence. Most patients experienced marked, immediate improvement of symptoms associated with their chief complaint. Substantial practicality issues must be addressed to implement EM clinically in a hospital, however.

PharMillenium '99--the second world pharmaceutical congress and exhibition. Accelerating the pipeline: from drug discovery to market. 1-3 February 1999, Washington DC, USA.

PubMed

Fernandes, M

1999-04-01

This highly interactive meeting effectively covered critical issues on every transaction from drug discovery through to development and commercialization. The program included company-specific descriptions of new discovery products, together with seminars by clinical research and site management organizations on the acceleration of development, pharmaco-economics, branding of products, direct-to-consumer advertising, global marketing, management, information technology and business strategy. There were approximately 50 sessions covered by 70 speakers.

Blood Sampling and Preparation Procedures for Proteomic Biomarker Studies of Psychiatric Disorders.

PubMed

Guest, Paul C; Rahmoune, Hassan

2017-01-01

A major challenge in proteomic biomarker discovery and validation for psychiatric diseases is the inherent biological complexity underlying these conditions. There are also many technical issues which hinder this process such as the lack of standardization in sampling, processing and storage of bio-samples in preclinical and clinical settings. This chapter describes a reproducible procedure for sampling blood serum and plasma that is specifically designed for maximizing data quality output in two-dimensional gel electrophoresis, multiplex immunoassay and mass spectrometry profiling studies.

Euthanasia: the role of the psychiatrist.

PubMed

Naudts, Kris; Ducatelle, Caroline; Kovacs, Jozsef; Laurens, Kristin; van den Eynde, Frederique; van Heeringen, Cornelis

2006-05-01

Belgium has become one of the few countries in the world where euthanasia is legally allowed within a specific juridical framework. Even more unique is the inclusion of grounds for requesting euthanasia on the basis of mental suffering. Further refinement of the legal, medical and psychiatric approach to the issue is required in order to clear up essential practical and ethical matters. Psychiatrists and their professional organisations need to play a greater role in this ongoing debate and contribute from a clinical, scientific and ethical point of view.

Establishing intensivist-driven ultrasound at the PICU bedside--it's about time*.

PubMed

Su, Erik; Pustavoitau, Aliaksei; Hirshberg, Elliotte L; Nishisaki, Akira; Conlon, Thomas; Kantor, David B; Weber, Mark D; Godshall, Aaron J; Burzynski, Jeffrey H; Thompson, Ann E

2014-09-01

To discuss pediatric intensivist-driven ultrasound and the exigent need for research and practice definitions pertaining to its implementation within pediatric critical care, specifically addressing issues in ultrasound-guided vascular access and intensivist-driven echocardiography. Intensivist-driven ultrasound improves procedure safety and reduces time to diagnosis in clinical ultrasound applications, as demonstrated primarily in adult patients. Translating these applications to the PICU requires thoughtful integration of the technology into practice and would best be informed by dedicated ultrasound research in critically ill children.

Drug addiction and diabetes: South Asian action.

PubMed

Singh Balhara, Yatan Pal; Kalra, Sanjay

2017-06-01

Both diabetes and drug addiction are common phenomena across the world. Drug abuse impacts glycaemic control in multiple ways. It becomes imperative, therefore, to share guidance on drug deaddiction in persons with diabetes. The South Asian subcontinent is home to specific forms and patterns of drug abuse. Detailed study is needed to ensure good clinical practice regarding the same. This communication provides a simple and pragmatic framework to address this issue, while calling for concerted action on drug deaddiction in South Asia.

[Do German articles in medical journals require a"guide to anglicisms"?].

PubMed

Huppert, D; Brandt, T

2013-12-01

Effective communication of scientific results depends on conceptually clear and precise language, especially with regards to the use of discipline-specific terminology. German scientific language might be more comprehensible if the overuse of anglicisms is avoided. As an example commonly used anglicisms in ten clinical studies published in Der Nervenarzt were selected, listed according to the field of application and evaluated. Adequate German terms are offered for them showing that it is possible to use German terms for most issues and facts.

Clinical reasoning in nursing, a think-aloud study using virtual patients - a base for an innovative assessment.

PubMed

Forsberg, Elenita; Ziegert, Kristina; Hult, Håkan; Fors, Uno

2014-04-01

In health-care education, it is important to assess the competencies that are essential for the professional role. To develop clinical reasoning skills is crucial for nursing practice and therefore an important learning outcome in nursing education programmes. Virtual patients (VPs) are interactive computer simulations of real-life clinical scenarios and have been suggested for use not only for learning, but also for assessment of clinical reasoning. The aim of this study was to investigate how experienced paediatric nurses reason regarding complex VP cases and how they make clinical decisions. The study was also aimed to give information about possible issues that should be assessed in clinical reasoning exams for post-graduate students in diploma specialist paediatric nursing education. The information from this study is believed to be of high value when developing scoring and grading models for a VP-based examination for the specialist diploma in paediatric nursing education. Using the think-aloud method, data were collected from 30 RNs working in Swedish paediatric departments, and child or school health-care centres. Content analysis was used to analyse the data. The results indicate that experienced nurses try to consolidate their hypotheses by seeing a pattern and judging the value of signs, symptoms, physical examinations, laboratory tests and radiology. They show high specific competence but earlier experience of similar cases was also of importance for the decision making. The nurses thought it was an innovative assessment focusing on clinical reasoning and clinical decision making. They thought it was an enjoyable way to be assessed and that all three main issues could be assessed using VPs. In conclusion, VPs seem to be a possible model for assessing the clinical reasoning process and clinical decision making, but how to score and grade such exams needs further research. © 2013.

Future of electronic health records: implications for decision support.

PubMed

Rothman, Brian; Leonard, Joan C; Vigoda, Michael M

2012-01-01

The potential benefits of the electronic health record over traditional paper are many, including cost containment, reductions in errors, and improved compliance by utilizing real-time data. The highest functional level of the electronic health record (EHR) is clinical decision support (CDS) and process automation, which are expected to enhance patient health and healthcare. The authors provide an overview of the progress in using patient data more efficiently and effectively through clinical decision support to improve health care delivery, how decision support impacts anesthesia practice, and how some are leading the way using these systems to solve need-specific issues. Clinical decision support uses passive or active decision support to modify clinician behavior through recommendations of specific actions. Recommendations may reduce medication errors, which would result in considerable savings by avoiding adverse drug events. In selected studies, clinical decision support has been shown to decrease the time to follow-up actions, and prediction has proved useful in forecasting patient outcomes, avoiding costs, and correctly prompting treatment plan modifications by clinicians before engaging in decision-making. Clinical documentation accuracy and completeness is improved by an electronic health record and greater relevance of care data is delivered. Clinical decision support may increase clinician adherence to clinical guidelines, but educational workshops may be equally effective. Unintentional consequences of clinical decision support, such as alert desensitization, can decrease the effectiveness of a system. Current anesthesia clinical decision support use includes antibiotic administration timing, improved documentation, more timely billing, and postoperative nausea and vomiting prophylaxis. Electronic health record implementation offers data-mining opportunities to improve operational, financial, and clinical processes. Using electronic health record data in real-time for decision support and process automation has the potential to both reduce costs and improve the quality of patient care. © 2012 Mount Sinai School of Medicine.

Large animal models in experimental knee sports surgery: focus on clinical translation.

PubMed

Madry, Henning; Ochi, Mitsuo; Cucchiarini, Magali; Pape, Dietrich; Seil, Romain

2015-12-01

Large animal models play a crucial role in sports surgery of the knee, as they are critical for the exploration of new experimental strategies and the clinical translation of novel techniques. The purpose of this contribution is to provide critical aspects of relevant animal models in this field, with a focus on paediatric anterior cruciate ligament (ACL) reconstruction, high tibial osteotomy, and articular cartilage repair. Although there is no single large animal model strictly replicating the human knee joint, the sheep stifle joint shares strong similarities. Studies in large animal models of paediatric ACL reconstruction identified specific risk factors associated with the different surgical techniques. The sheep model of high tibial osteotomy is a powerful new tool to advance the understanding of the effect of axial alignment on the lower extremity on specific issues of the knee joint. Large animal models of both focal chondral and osteochondral defects and of osteoarthritis have brought new findings about the mechanisms of cartilage repair and treatment options. The clinical application of a magnetic device for targeted cell delivery serves as a suitable example of how data from such animal models are directly translated into in clinical cartilage repair. As novel insights from studies in these translational models will advance the basic science, close cooperation in this important field of clinical translation will improve current reconstructive surgical options and open novel avenues for regenerative therapies of musculoskeletal disorders.

Gender Differences in Treatment-Seeking British Pathological Gamblers

PubMed Central

Ronzitti, Silvia; Lutri, Vittorio; Smith, Neil; Clerici, Massimo; Bowden-Jones, Henrietta

2016-01-01

Background and aim Gambling is a widespread recreational activity in the UK. A significant percentage of gamblers develop subclinical or clinically relevant problem gambling issues, but only a low percentage of them seek treatment. Although characteristics of pathological gamblers from treatment-seeking population have been examined in some research, only a few studies have explored the differences between females and males. This study aimed to examine the gender-related differences in demographics, gambling measures, and clinical variables in an outpatient sample of pathological gamblers seeking treatment. Methods A total of 1,178 treatment-seeking individuals with gambling disorder were assessed at the National Problem Gambling Clinic in London. Sociodemographic characteristics, clinical variables, and gambling behavior habits were obtained during the assessment evaluation. Of the total sample, 92.5% were males and 7.5% were females. Results Males were more likely to be younger, white, and employed than females. In addition, compared to women, men showed a lower PGSI score, an earlier age of onset of gambling behavior, a higher gambling involvement, and preferred specific forms gambling. Female gamblers were more anxious and depressed, while men were more likely to use alcohol and illicit drugs. Conclusions Our findings support the importance of gender differences in a treatment-seeking population of pathological gamblers both in sociodemographic characteristics, gambling behavior variables, and clinical variables. Males and females might benefit from group-specific treatment. PMID:27348561

Innovative Solutions for Clinical Trial Follow-up: Adding Value from Nationally Held UK Data.

PubMed

Appleyard, S E; Gilbert, D C

2017-12-01

Clinical trials provide the data that underpin evidence-based oncological practice. Over and above their primary outcome measures, collected and analysed by the clinical trials unit, trials provide an opportunity to generate a wide range of additional information over a prolonged period of time. Nationally held data have potential to facilitate longer term follow-up and explore associated toxicities and downstream consequences and in the UK include data from secondary care, including hospital episode statistics, national chemotherapy and radiotherapy datasets and primary care records. Specific to use in oncological practice, the National Cancer Data Repository contains linked data from a variety of sources for patients with a diagnosis of cancer, both cancer and non-cancer related. The challenge of using these data in clinical trials relates to the need to extract identifiable patient data, with the associated ethical and legal issues. The data access processes are time consuming and require evidence of information governance compliance. This overview article reviews the current data available, the current and potential uses both within and outside clinical trials and the challenges encountered in the process of acquiring data. We focus specifically on the use of nationally held data for non-cancer outcomes, including toxicity and associated conditions. Copyright © 2017 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

PubMed

Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

2005-09-01

To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

The treatment of adolescent transsexuals: changing insights.

PubMed

Cohen-Kettenis, Peggy T; Delemarre-van de Waal, Henriette A; Gooren, Louis J G

2008-08-01

Treatment of individuals with gender identity disorder (GID) has in medicine nearly always met with a great deal of skepticism. Professionals largely follow the Standards of Care of the World Professional Association for Transgender Health. For adolescents, specific guidelines have also been issued by the British Royal College of Psychiatrists. To describe the stepwise changes in treatment policy which, in recent years, have been made by the team of the Gender Identity Clinic at the VU University Medical Center in Amsterdam, The Netherlands. The first step taken to treat adolescents was that, after careful evaluation, (cross-sex hormone) treatment could start between the ages of 16 and 18 years. A further step was the suppression of puberty by means of gonadotropin-releasing hormone analogs in 12-16 year olds; the latter serves also as a diagnostic tool. Very recently, other clinics in Europe and North America have followed this policy. Results. The first results from the Amsterdam clinic show that this policy is promising. Professionals who take responsibility for these youth and are willing to help should yet be fully aware of the impact of their interventions. In this article, the pros and cons of the various approaches to youngsters with GID are presented, hopefully inciting a sound scientific discussion of the issue.

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

When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

PubMed

de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

2011-09-01

For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

In this issue: Nef, a lingering problem; are there better immunoglobulins for human use; and Takayasu arteritis, still a mystery.

PubMed

Bot, Adrian

2012-12-01

The current issue of the International Reviews of Immunology brings the latest in three different areas of basic and clinical immunology. First, there is the lingering question of residual HIV-related pathology in patients on chronic antiretroviral therapy. The specific role of Nef in the macrophage-mediated disease manifested through lymphoma, metabolic disease and neurological disorder, is extensively discussed. A second topic is a clinical immunology one, a critical perspective on the efficacy and safety profile of various preparations of immunoglobulin products currently prescribed for a range of immunodeficiencies. Surprisingly, the authors showed that while the available preparations are equivalent from efficacy standpoint, they differ from the standpoint of toxicity. The third subject is again, in the arena of clinical immunology and deals with a relatively rare yet extremely puzzling disease -Takayasu arteritis -with a pathogenesis that needs elucidation and a dire need for better treatments. The authors provide a state of the art in terms of genetic association, other factors possibly involved in the onset and progression of this unusual inflammatory disease of large arteries, and provide a perspective on current standard of care and potential usefulness of TNF-α blockade as therapy for Takayasu arteritis.

Osimertinib for the treatment of non-small cell lung cancer.

PubMed

Sun, Jong-Mu; Lee, Se-Hoon; Ahn, Jin Seok; Park, Keunchil; Ahn, Myung-Ju

2017-02-01

The T790 M mutation of the epidermal growth factor receptor (EGFR) gene is the most common mechanism underlying resistance to first- or second-generation EGFR tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancer (NSCLC). Osimertinib, a third-generation EGFR TKI, shows robust clinical efficacy in patients with T790 M-mutated lung cancer. Areas covered: We analyzed and reviewed clinical data for which patients who experienced acquired resistance to first- or second-generation EGFR TKIs. In addition, we briefly reviewed the potential role of osimertinib as a first-line therapy. Expert opinion: Osimertinib was recently licensed for use in NSCLC patients with acquired resistance to other EGFR TKIs due to a T790 M mutation. However, unresolved issues surrounding the optimal application of osimertinib remain, specifically the development of a plasma-based mutation test to overcome the difficulty of repeat biopsy, the efficacy of osimertinib for brain or leptomeningeal metastases, the development of resistance to osimertinib, and the use of osimertinib therapy as a first-line treatment. Many ongoing studies are currently exploring these issues.

Translational Cognition for Decision Support in Critical Care Environments: A Review

PubMed Central

Patel, Vimla L.; Zhang, Jiajie; Yoskowitz, Nicole A.; Green, Robert; Sayan, Osman R.

2008-01-01

The dynamic and distributed work environment in critical care requires a high level of collaboration among clinical team members and a sophisticated task coordination system to deliver safe, timely and effective care. A complex cognitive system underlies the decision-making process in such cooperative workplaces. This methodological review paper addresses the issues of translating cognitive research to clinical practice with a specific focus on decision-making in critical care, and the role of information and communication technology to aid in such decisions. Examples are drawn from studies of critical care in our own research laboratories. Critical care, in this paper, includes both intensive (inpatient) and emergency (outpatient) care. We define translational cognition as the research on basic and applied cognitive issues that contribute to our understanding of how information is stored, retrieved and used for problem-solving and decision-making. The methods and findings are discussed in the context of constraints on decision-making in real world complex environments and implications for supporting the design and evaluation of decision support tools for critical care health providers. PMID:18343731

Translational cognition for decision support in critical care environments: a review.

PubMed

Patel, Vimla L; Zhang, Jiajie; Yoskowitz, Nicole A; Green, Robert; Sayan, Osman R

2008-06-01

The dynamic and distributed work environment in critical care requires a high level of collaboration among clinical team members and a sophisticated task coordination system to deliver safe, timely and effective care. A complex cognitive system underlies the decision-making process in such cooperative workplaces. This methodological review paper addresses the issues of translating cognitive research to clinical practice with a specific focus on decision-making in critical care, and the role of information and communication technology to aid in such decisions. Examples are drawn from studies of critical care in our own research laboratories. Critical care, in this paper, includes both intensive (inpatient) and emergency (outpatient) care. We define translational cognition as the research on basic and applied cognitive issues that contribute to our understanding of how information is stored, retrieved and used for problem-solving and decision-making. The methods and findings are discussed in the context of constraints on decision-making in real-world complex environments and implications for supporting the design and evaluation of decision support tools for critical care health providers.

Patients' satisfaction with sexual and reproductive health services delivered in HIV clinics across European regions.

PubMed

Platteau, Tom; Müller, Matthias C; Nideröst, Sibylle; Csepe, Peter; Dedes, Nikos; Apers, Ludwig; Schrooten, Ward; Nöstlinger, Christiana

2013-09-01

Throughout Europe, differences in satisfaction with HIV-care of people living with HIV (PLHIV) persist, despite a tendency towards harmonisation of policy and management. A European sample of 1,549 PLHIV responded to an anonymous questionnaire assessing demographic background, general health, mental health, sexual health, and HIV-service provision. We compared the results across 3 regions: Western, Southern and Central/Eastern Europe. PLHIV differed in several socio-demographic variables (gender, migrant status, sexual orientation, and financial situation) as well as specific psychosocial aspects (HIV-related discrimination, satisfaction with sexual and reproductive health (SRH) services in HIV-care settings, and complaints about service provision). Using multivariate analysis, a predictive model for satisfaction with SRH services in HIV clinics was developed, resulting into region of residence, and participants' satisfaction with their own health status as significant predictors. Better integration of SRH services in HIV-care should be encouraged. Service providers should be trained and encouraged to discuss SRH issues with their patients to create a supportive environment, free of discrimination. More time should be allocated to discuss SRH issues with individual patients.

[Issues in psychiatric evaluation of children and adolescents with visual impairment].

PubMed

Saisky, Yaniv; Hasid, Soli; Ebert, Tanya; Kosov, Irene

2014-02-01

Approximately 8% from those who are defined as blind in Israel are children and adolescents. Visual impairment is correlated with a high rate of psychopathology. However, some of these children and adolescents do not receive appropriate diagnosis and treatment. Often, the clinicians and those who treat the children/adolescents lack the proper professional knowledge related to the unique diagnosis and treatment of children/ adolescents who are visually impaired. Visual impairment might influence different aspects of the psychiatric diagnosis. These aspects include the influence of the impairment on different developmental axes; the reciprocal relationship between the child and his/her environment; the clinical presentation of different psychopathologies; and the different treatment modalities. In this review we discuss these issues. Moreover, we raise the question as to whether there is a need to adapt the psychiatric evaluation and the treatment specifically to the visually impaired child. The review is based on the existing literature in addition to our clinical experience, which stems from our work with children and adolescents who are at the "Jewish Institute for the Blind", an institute for children and adolescents with visual impairment in Israel.

Inclusion of adolescents in preventive HIV vaccine trials: public health policy and research design at a crossroads.

PubMed

Jaspan, Heather B; Cunningham, Coleen K; Tucker, Tim J P; Wright, Peter F; Self, Steve G; Sheets, Rebecca L; Rogers, Audrey S; Bekker, Linda-Gail; Wilson, Craig M; Duerr, Ann; Wasserheit, Judith N

2008-01-01

The search for a safe effective HIV vaccine has been a centerpiece of HIV research for almost 2 decades. More than 60 clinical HIV vaccine trials have been conducted to date. Several promising candidate HIV vaccines are in advanced clinical development. To date, however, no trial has included adolescents, one of the most important target groups for any preventive HIV vaccine. To license a vaccine for use in this age group, efficacy data or, at a minimum, bridging safety and immunogenicity data in this population are needed. To accomplish this, several critical issues and special challenges in the development and implementation of HIV vaccine trials in adolescents must be addressed, including regulatory considerations, potential differentials in safety and immunogenicity, alternative trial design strategies, recruitment and retention challenges, community involvement models, and approaches to informed consent/assent. This article examines these issues and proposes specific next steps to facilitate the routine inclusion of this high-priority population in preventive HIV vaccine trials as early and seamlessly as possible.

Controversies regarding the new oral anticoagulants for stroke prevention in patients with atrial fibrillation.

PubMed

Mohanty, Bibhu D; Looser, Patrick M; Gokanapudy, Lakshmi R; Handa, Rishi; Mohanty, Sudipta; Choi, Sharon S; Goldman, Martin E; Fuster, Valentin; Halperin, Jonathan L

2014-06-01

Increasing use of the new oral anticoagulants (NOACs) - dabigatran, rivaroxaban, and apixaban - has prompted considerable discussion in the medical community even as warfarin remains the mainstay of therapy. This article raises 10 controversial issues regarding the use of NOACs for stroke prevention in patients with atrial fibrillation, and offers a review of the latest available evidence. We provide a brief overview of the mechanism and dosing of these drugs, as well as a summary of the key clinical trials that have brought them into the spotlight. Comparative considerations relative to warfarin such as NOAC safety, efficacy, bleeding risk, reversibility, drug-transitioning and use in patients well controlled on warfarin are addressed. Use in select populations such as the elderly, those with coronary disease, renal impairment, or on multiple anti-platelet drugs is also discussed. Finally, we consider such specific issues as comparative efficacy, off-label use, cost, rebound and management during events. Ultimately, the rise of the NOACs to mainstream use will depend on further data and clinical experience amongst the medical community. © The Author(s) 2014.

Handheld Fluorescence Microscopy based Flow Analyzer.

PubMed

Saxena, Manish; Jayakumar, Nitin; Gorthi, Sai Siva

2016-03-01

Fluorescence microscopy has the intrinsic advantages of favourable contrast characteristics and high degree of specificity. Consequently, it has been a mainstay in modern biological inquiry and clinical diagnostics. Despite its reliable nature, fluorescence based clinical microscopy and diagnostics is a manual, labour intensive and time consuming procedure. The article outlines a cost-effective, high throughput alternative to conventional fluorescence imaging techniques. With system level integration of custom-designed microfluidics and optics, we demonstrate fluorescence microscopy based imaging flow analyzer. Using this system we have imaged more than 2900 FITC labeled fluorescent beads per minute. This demonstrates high-throughput characteristics of our flow analyzer in comparison to conventional fluorescence microscopy. The issue of motion blur at high flow rates limits the achievable throughput in image based flow analyzers. Here we address the issue by computationally deblurring the images and show that this restores the morphological features otherwise affected by motion blur. By further optimizing concentration of the sample solution and flow speeds, along with imaging multiple channels simultaneously, the system is capable of providing throughput of about 480 beads per second.

The clinical application of research utilization: amphotericin B.

PubMed

Reedy, A M; Shivnan, J C; Hanson, J L; Haisfield, M E; Gregory, R E

1994-05-01

To describe the first application of the research utilization process by clinical nurses using the Stetler-Marram Model of Research Utilization to the practice of amphotericin B administration; to share the findings; and to discuss issues encountered in the process and their solutions. Published articles identified through computerized literature searches, published abstracts and books, personal communication with one author, and an informal survey of other cancer centers' amphotericin B infusion practices; research articles were selected for review if studies included settings and patient populations similar to those of the authors and if they used experimental designs. Studies were reviewed for scientific merit and clinical applicability according to the Stetler-Marram model; findings were used to develop a specific nursing protocol for infusion times of amphotericin B based on clinical criteria. The Stetler-Marram model helped staff nurses decide how to apply research findings to practice, although using it was difficult and required mentorship. A research base exists for amphotericin B administration time but not for test doses or premedications to prevent or minimize side effects. Staff nurses can use the Stetler-Marram model but need resources and support from individuals, committees, and administration. A specific protocol representing a practice change was implemented and may be applicable to other settings.

Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

PubMed Central

2014-01-01

Background Anxiety and related disorders are among the most common mental disorders, with lifetime prevalence reportedly as high as 31%. Unfortunately, anxiety disorders are under-diagnosed and under-treated. Methods These guidelines were developed by Canadian experts in anxiety and related disorders through a consensus process. Data on the epidemiology, diagnosis, and treatment (psychological and pharmacological) were obtained through MEDLINE, PsycINFO, and manual searches (1980–2012). Treatment strategies were rated on strength of evidence, and a clinical recommendation for each intervention was made, based on global impression of efficacy, effectiveness, and side effects, using a modified version of the periodic health examination guidelines. Results These guidelines are presented in 10 sections, including an introduction, principles of diagnosis and management, six sections (Sections 3 through 8) on the specific anxiety-related disorders (panic disorder, agoraphobia, specific phobia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder), and two additional sections on special populations (children/adolescents, pregnant/lactating women, and the elderly) and clinical issues in patients with comorbid conditions. Conclusions Anxiety and related disorders are very common in clinical practice, and frequently comorbid with other psychiatric and medical conditions. Optimal management requires a good understanding of the efficacy and side effect profiles of pharmacological and psychological treatments. PMID:25081580

Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 1

PubMed Central

McRorie, Johnson W.

2015-01-01

Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. The first part (current issue) of this 2-part series will focus on the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (next issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972618

Evidence-Based Approach to Fiber Supplements and Clinically Meaningful Health Benefits, Part 2

PubMed Central

McRorie, Johnson W.

2015-01-01

Dietary fiber that is intrinsic and intact in fiber-rich foods (eg, fruits, vegetables, legumes, whole grains) is widely recognized to have beneficial effects on health when consumed at recommended levels (25 g/d for adult women, 38 g/d for adult men). Most (90%) of the US population does not consume this level of dietary fiber, averaging only 15 g/d. In an attempt to bridge this “fiber gap,” many consumers are turning to fiber supplements, which are typically isolated from a single source. Fiber supplements cannot be presumed to provide the health benefits that are associated with dietary fiber from whole foods. Of the fiber supplements on the market today, only a minority possess the physical characteristics that underlie the mechanisms driving clinically meaningful health benefits. In this 2-part series, the first part (previous issue) described the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, viscosity, and gel formation), the 4 clinically meaningful designations that identify which health benefits are associated with specific fibers, and the gel-dependent mechanisms in the small bowel that drive specific health benefits (eg, cholesterol lowering, improved glycemic control). The second part (current issue) of this 2-part series will focus on the effects of fiber supplements in the large bowel, including the 2 mechanisms by which fiber prevents/relieves constipation (insoluble mechanical irritant and soluble gel-dependent water-holding capacity), the gel-dependent mechanism for attenuating diarrhea and normalizing stool form in irritable bowel syndrome, and the combined large bowel/small bowel fiber effects for weight loss/maintenance. The second part will also discuss how processing for marketed products can attenuate efficacy, why fiber supplements can cause gastrointestinal symptoms, and how to avoid symptoms for better long-term compliance. PMID:25972619

Clinical, CSF, and MRI findings in Devic's neuromyelitis optica.

PubMed Central

O'Riordan, J I; Gallagher, H L; Thompson, A J; Howard, R S; Kingsley, D P; Thompson, E J; McDonald, W I; Miller, D H

1996-01-01

OBJECTIVES: Since Devic's original description of neuromyelitis optica in 1894 there has been much debate regarding its aetiology. A specific cause has been identified in a minority of cases but in most the question has arisen whether or not Devic's neuromyelitis optica is a variant of multiple sclerosis. This study was undertaken to help clarify this issue. METHODS: Neuromyelitis optica was defined as (1) a severe transverse myelitis; (2) an acute unilateral or bilateral optic neuropathy; (3) no clinical involvement beyond the spinal cord or optic nerves, and (4) a monophasic or multiphasic illness. The clinical and autoantibody status was documented. Patients underwent CSF examination and MRI of brain and spinal cord. RESULTS: Twelve patients, with a mean age of presentation of 35.1 years, were seen. Eleven were women; vision was reduced to counting fingers or worse in 10 patients and seven became confined to a wheelchair. Examination of CSF showed local synthesis of oligoclonal bands in only two patients and a neutrophil pleocytosis in two. A possible aetiology was identified in five: a specific connective tissue disorder (two), pulmonary tuberculosis (one), and possible acute disseminated encephalomyelitis (two). Six had non-specific increases in various autoantibodies. Eleven patients underwent MRI of the brain and spinal cord. In 10 there were diffuse abnormalities involving cervical and thoracic cords with extensive swelling in the acute phase. Brain MRI was normal in five; in five there were multiple deep white matter lesions, and one patient had minor age related changes. CONCLUSION: It is proposed that Devic's neuromyelitis optica is a distinctive disorder with some clinical, CSF, and MRI features different from those found in classic multiple sclerosis. In most cases a specific aetiology is not identified, but an immunological mechanism of tissue damage seems likely. Images PMID:8774400

Elbow-specific clinical rating systems: extent of established validity, reliability, and responsiveness.

PubMed

The, Bertram; Reininga, Inge H F; El Moumni, Mostafa; Eygendaal, Denise

2013-10-01

The modern standard of evaluating treatment results includes the use of rating systems. Elbow-specific rating systems are frequently used in studies aiming at elbow-specific pathology. However, proper validation studies seem to be relatively sparse. In addition, these scoring systems might not always be used for appropriate populations of interest. Both of these issues might give rise to invalid conclusions being reported in the literature. Our aim was to investigate the extent to which the available elbow-specific outcome measurement tools have been validated and the quality of the validation itself. We also aimed to provide characteristics of the populations used for validation of these scales to enable clinicians to use them appropriately. A literature search identified 17 studies of 12 different elbow-specific scoring systems. These were assessed for validity, reliability, and responsiveness characteristics. The quality of these assessments was rated according to the Consensus Based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist criteria, a standardized and validated tool developed specifically for this purpose. Currently, the only elbow-specific rating system that is validated using high-quality methodology is the Oxford Elbow Score, a patient-administered outcome measure tool that has been validated on heterogeneous study populations. Other rating systems still have to be proven in the future to be as good as the Oxford Elbow Score for clinical or research purposes. Additional validation studies are needed. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

[Analysis of rational clinical uses of traditional Chinese medicine injections and factors influencing adverse drug reactions].

PubMed

Sun, Shi-Guang; Li, Zi-Feng; Xie, Yan-Ming; Liu, Jian; Lu, Yan; Song, Yi-Fei; Han, Ying-Hua; Liu, Li-Da; Peng, Ting-Ting

2013-09-01

To rationalize the clinical use and safety are some of the key issues in the surveillance of traditional Chinese medicine injections (TCMIs). In this 2011 study, 240 medical records of patients who had been discharged following treatment with TCMIs between 1 and 12 month previously were randomly selected from hospital records. Consistency between clinical use and the description of TCMIs was evaluated. Research on drug use and adverse drug reactions/events using logistic regression analysis was carried out. There was poor consistency between clinical use and best practice advised in manuals on TCMIs. Over-dosage and overly concentrated administration of TCMIs occurred, with the outcome of modifying properties of the blood. Logistic regression analysis showed that, drug concentration was a valid predictor for both adverse drug reactions/events and benefits associated with TCMIs. Surveillance of rational clinical use and safety of TCMIs finds that clinical use should be consistent with technical drug manual specifications, and drug use should draw on multi-layered logistic regression analysis research to help avoid adverse drug reactions/events.

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

The maze and the minotaur: mental health in primary health care.

PubMed

Hirdes, Alice; Scarparo, Helena Beatriz Kochenborger

2015-02-01

The article aims to discuss the issue of integration of mental health in primary care by matrix support in mental health. We point out the main barriers in the use of this work method, as well as the facilitating factors of the matrix support of mental health in primary care. The first are within the scope of epistemological specificities, professional issues and management in the political and ideological dimensions. Among the second, we highlight: the care for people with mental disorders in the territory; the reduction of stigma and discrimination; the development of new skills for professionals in primary care; reduction of costs; simultaneous treatment of physical and mental illness, which often overlap; the possibility of incorporating mental health care in a perspective of extended clinical service using an inter/transdisciplinary approach.

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.

Cancer biology and genomics: translating discoveries, transforming pathology.

PubMed

Ladanyi, Marc; Hogendoorn, Pancras C W

2011-01-01

Advances in our understanding of cancer biology and discoveries emerging from cancer genomics are being translated into real clinical benefits for patients with cancer. The 2011 Journal of Pathology Annual Review Issue provides a snapshot of recent rapid progress on multiple fronts in the war on cancer or, more precisely, the wars on cancers. Indeed, perhaps the most notable recent shift is reflected by the sharp increase in understanding the biology of multiple specific cancers and using these new insights to inform rationally targeted therapies, with often striking successes. These recent developments, as reviewed in this issue, show how the long-term investments in basic cancer research are finally beginning to bear fruit. Copyright © 2010 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.

A multiple imputation strategy for sequential multiple assignment randomized trials

PubMed Central

Shortreed, Susan M.; Laber, Eric; Stroup, T. Scott; Pineau, Joelle; Murphy, Susan A.

2014-01-01

Sequential multiple assignment randomized trials (SMARTs) are increasingly being used to inform clinical and intervention science. In a SMART, each patient is repeatedly randomized over time. Each randomization occurs at a critical decision point in the treatment course. These critical decision points often correspond to milestones in the disease process or other changes in a patient’s health status. Thus, the timing and number of randomizations may vary across patients and depend on evolving patient-specific information. This presents unique challenges when analyzing data from a SMART in the presence of missing data. This paper presents the first comprehensive discussion of missing data issues typical of SMART studies: we describe five specific challenges, and propose a flexible imputation strategy to facilitate valid statistical estimation and inference using incomplete data from a SMART. To illustrate these contributions, we consider data from the Clinical Antipsychotic Trial of Intervention and Effectiveness (CATIE), one of the most well-known SMARTs to date. PMID:24919867

Validation of a quality-of-life instrument for patients with nonmelanoma skin cancer.

PubMed

Rhee, John S; Matthews, B Alex; Neuburg, Marcy; Logan, Brent R; Burzynski, Mary; Nattinger, Ann B

2006-01-01

To validate a disease-specific quality-of-life instrument--the Skin Cancer Index--intended to measure quality-of-life issues relevant to patients with nonmelanoma skin cancer. Internal reliability, convergent and divergent validity with existing scales, and factor analyses were performed in a cross-sectional study of 211 patients presenting with cervicofacial nonmelanoma skin cancer to a dermatologic surgery clinic. Factor analyses of the Skin Cancer Index confirmed a multidimensional scale with 3 distinct subscales-emotional, social, and appearance. Excellent internal validity of the 3 subscales was demonstrated. Substantial evidence was observed for convergent validity with the Dermatology Life Quality Index, Rosenberg Self-Esteem Scale, Lerman's Cancer Worry Scale, and Medical Outcomes Survey Short-Form 12 domains for vitality, emotion, social function, and mental health. These findings validate a new disease-specific quality-of-life instrument for patients with cervicofacial nonmelanoma skin cancer. Studies on the responsiveness of the Skin Cancer Index to clinical intervention are currently under way.

Characterizing a psychiatric symptom dimension related to deficits in goal-directed control

PubMed Central

Gillan, Claire M; Kosinski, Michal; Whelan, Robert; Phelps, Elizabeth A; Daw, Nathaniel D

2016-01-01

Prominent theories suggest that compulsive behaviors, characteristic of obsessive-compulsive disorder and addiction, are driven by shared deficits in goal-directed control, which confers vulnerability for developing rigid habits. However, recent studies have shown that deficient goal-directed control accompanies several disorders, including those without an obvious compulsive element. Reasoning that this lack of clinical specificity might reflect broader issues with psychiatric diagnostic categories, we investigated whether a dimensional approach would better delineate the clinical manifestations of goal-directed deficits. Using large-scale online assessment of psychiatric symptoms and neurocognitive performance in two independent general-population samples, we found that deficits in goal-directed control were most strongly associated with a symptom dimension comprising compulsive behavior and intrusive thought. This association was highly specific when compared to other non-compulsive aspects of psychopathology. These data showcase a powerful new methodology and highlight the potential of a dimensional, biologically-grounded approach to psychiatry research. DOI: http://dx.doi.org/10.7554/eLife.11305.001 PMID:26928075

Usability study of clinical exome analysis software: top lessons learned and recommendations.

PubMed

Shyr, Casper; Kushniruk, Andre; Wasserman, Wyeth W

2014-10-01

New DNA sequencing technologies have revolutionized the search for genetic disruptions. Targeted sequencing of all protein coding regions of the genome, called exome analysis, is actively used in research-oriented genetics clinics, with the transition to exomes as a standard procedure underway. This transition is challenging; identification of potentially causal mutation(s) amongst ∼10(6) variants requires specialized computation in combination with expert assessment. This study analyzes the usability of user interfaces for clinical exome analysis software. There are two study objectives: (1) To ascertain the key features of successful user interfaces for clinical exome analysis software based on the perspective of expert clinical geneticists, (2) To assess user-system interactions in order to reveal strengths and weaknesses of existing software, inform future design, and accelerate the clinical uptake of exome analysis. Surveys, interviews, and cognitive task analysis were performed for the assessment of two next-generation exome sequence analysis software packages. The subjects included ten clinical geneticists who interacted with the software packages using the "think aloud" method. Subjects' interactions with the software were recorded in their clinical office within an urban research and teaching hospital. All major user interface events (from the user interactions with the packages) were time-stamped and annotated with coding categories to identify usability issues in order to characterize desired features and deficiencies in the user experience. We detected 193 usability issues, the majority of which concern interface layout and navigation, and the resolution of reports. Our study highlights gaps in specific software features typical within exome analysis. The clinicians perform best when the flow of the system is structured into well-defined yet customizable layers for incorporation within the clinical workflow. The results highlight opportunities to dramatically accelerate clinician analysis and interpretation of patient genomic data. We present the first application of usability methods to evaluate software interfaces in the context of exome analysis. Our results highlight how the study of user responses can lead to identification of usability issues and challenges and reveal software reengineering opportunities for improving clinical next-generation sequencing analysis. While the evaluation focused on two distinctive software tools, the results are general and should inform active and future software development for genome analysis software. As large-scale genome analysis becomes increasingly common in healthcare, it is critical that efficient and effective software interfaces are provided to accelerate clinical adoption of the technology. Implications for improved design of such applications are discussed. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

A longitudinal study of empathy in pre-clinical and clinical medical students and clinical supervisors.

PubMed

Mahoney, Sarah; Sladek, Ruth M; Neild, Tim

2016-10-18

Although appropriate empathy in health professionals is essential, a loss of empathy can occur during medical education. The structure of clinical learning may be one factor that is implicated in a loss of empathy. This study examines student and doctor empathy, and possible associations between empathy and the structure of clinical learning. There were three groups of participants: medical students (n = 281), who completed a longitudinal survey consisting of the Jefferson Scale of Empathy and an open question about empathy at the beginning and end of the 2013 academic year; private doctors (medical practitioners) in South Australia (n = 78) who completed a survey consisting of the Jefferson Scale of Empathy and an open question about empathy at the end of the students' academic year; and doctors (medical practitioners) from public teaching hospitals (n = 72) in southern Adelaide, South Australia who completed a survey consisting of the Jefferson Scale of Empathy at the end of the students' academic year . Year one students' empathy scores at the end of the year (102.8 ± 17.7) were significantly lower than at the start of the year (112.3 ± 9.6) p < .05). There were no other significant differences in students' empathy scores by year groups or across the two time points. Empathy scores were almost identical for private and hospital clinicians and higher than average scores for students. Free-text comments highlighted the importance students and doctors place on empathy. Students described issues that adversely affected their empathy, including specific incidents, systemic issues, and course structure, but also described some positive role models. Doctors' comments focused on the importance of empathy but qualified its meaning in the therapeutic setting. Medical students and practitioners alike ascribe importance to empathy in clinical practice, yet its developmental course remains poorly understood with possible decrement across the course of medical education. A more sophisticated understanding of empathy in medical students is needed, with attention to issues that might adversely impact on this crucial aspect of their development. This was not undertaken as the research did not involve a health care intervention on human participants.

An exploration into study design for biomarker identification: issues and recommendations.

PubMed

Hall, Jacqueline A; Brown, Robert; Paul, Jim

2007-01-01

Genomic profiling produces large amounts of data and a challenge remains in identifying relevant biological processes associated with clinical outcome. Many candidate biomarkers have been identified but few have been successfully validated and make an impact clinically. This review focuses on some of the study design issues encountered in data mining for biomarker identification with illustrations of how study design may influence the final results. This includes issues of clinical endpoint use and selection, power, statistical, biological and clinical significance. We give particular attention to study design for the application of supervised clustering methods for identification of gene networks associated with clinical outcome and provide recommendations for future work to increase the success of identification of clinically relevant biomarkers.

Clinical Neuropsychology in Integrated Rehabilitation Care Teams.

PubMed

Johnson-Greene, Doug

2018-05-01

Neuropsychologists have been an integral part of rehabilitation-oriented integrated care teams for some time and they provide care that is complimentary to other specialties, such as rehabilitation psychologists. Neuropsychologists are more likely than other specialties to offer objective cognitive data that includes consideration of emotional and behavioral features when assessing patients who have known or suspected brain injury or illness. Objective cognitive data is then often used for treatment and discharge planning as well as anticipating safety issues and impairment of functional skills. Unlike a consultative model, neuropsychologists in rehabilitation must work as part of a team of rehabilitation professionals and understand the contributions each specialty offers patients. This paper will highlight a number of issues pertaining to the practice of neuropsychology in rehabilitation settings including: (i) essential skills and duties, (ii) reimbursement, (iii) practice specifics, (iv) types of recommendations, (v) communication issues, (vi) impact of neuropsychological services, (vii) role satisfaction; (viii) advice for early career neuropsychologists, and (ix) a sample report.

Ethical Issues in Stem Cell Research

PubMed Central

Lo, Bernard; Parham, Lindsay

2009-01-01

Stem cell research offers great promise for understanding basic mechanisms of human development and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord injury, Parkinson’s disease, and myocardial infarction. However, human stem cell (hSC) research also raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes about the onset of human personhood. The reprogramming of somatic cells to produce induced pluripotent stem cells avoids the ethical problems specific to embryonic stem cell research. In any hSC research, however, difficult dilemmas arise regarding sensitive downstream research, consent to donate materials for hSC research, early clinical trials of hSC therapies, and oversight of hSC research. These ethical and policy issues need to be discussed along with scientific challenges to ensure that stem cell research is carried out in an ethically appropriate manner. This article provides a critical analysis of these issues and how they are addressed in current policies. PMID:19366754

Dementia in Latin America

PubMed Central

Parra, Mario A.; Baez, Sandra; Allegri, Ricardo; Nitrini, Ricardo; Lopera, Francisco; Slachevsky, Andrea; Custodio, Nilton; Lira, David; Piguet, Olivier; Kumfor, Fiona; Huepe, David; Cogram, Patricia; Bak, Thomas; Manes, Facundo

2018-01-01

The demographic structure of Latin American countries (LAC) is fast approaching that of developing countries, and the predicted prevalence of dementia in the former already exceeds the latter. Dementia has been declared a global challenge, yet regions around the world show differences in both the nature and magnitude of such a challenge. This article provides evidence and insights on barriers which, if overcome, would enable the harmonization of strategies to tackle the dementia challenge in LAC. First, we analyze the lack of available epidemiologic data, the need for standardizing clinical practice and improving physician training, and the existing barriers regarding resources, culture, and stigmas. We discuss how these are preventing timely care and research. Regarding specific health actions, most LAC have minimal mental health facilities and do not have specific mental health policies or budgets specific to dementia. In addition, local regulations may need to consider the regional context when developing treatment and prevention strategies. The support needed nationally and internationally to enable a smooth and timely transition of LAC to a position that integrates global strategies is highlighted. We focus on shared issues of poverty, cultural barriers, and socioeconomic vulnerability. We identify avenues for collaboration aimed to study unique populations, improve valid assessment methods, and generate opportunities for translational research, thus establishing a regional network. The issues identified here point to future specific actions aimed at tackling the dementia challenge in LAC. PMID:29305437

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.

Rare cancers: Challenges & issues.

PubMed

Pillai, Raveendran K; Jayasree, K

2017-01-01

Rare cancers account for about 22 per cent of all cancers diagnosed worldwide, disproportionately affecting some demographic groups, with an occurrence of less than 6 per 100,000 individuals annually. Many rare cancers in adults, adolescents and children are not curable, and patients and care providers have little option to take therapeutic decisions. The epidemiology of rare cancers is a challenging area of study but is inadequately addressed. Despite efforts mainly in some European nations, a few improvements have been observed in the management of rare cancers. Reasons for this obvious stagnation are multifactorial and are mainly inherent to logistical difficulties in carrying out clinical trials in very small patient populations, hesitation of the pharmaceutical industry to spend in small markets and complexity in creating adequate information for the development of cost-effective drugs. Rare cancers also face specific challenges that include late and incorrect diagnosis, lack of clinical expertise and lack of research interest and development of new therapies. The utilization of nationally representative study findings for the patients' evaluation may possibly offer chances to find out pathogenesis and prevalence, and this will eventually lead to control and prevention. Currently, advancing targeted therapies offer a great opportunity for the better management of rare cancers. Conducting clinical trials with small patient population, innovative clinical trial approach, prevailing controlling obstacles for international cooperation and financial support for research are the present challenges for rare cancers. The International Rare Cancers Initiative functions as a main platform for achieving new international clinical trials in rare tumours. This review delineates the current challenges and issues in the interpretation, management and research scenarios of rare cancers.

Rare cancers: Challenges & issues

PubMed Central

Pillai, Raveendran K.; Jayasree, K.

2017-01-01

Rare cancers account for about 22 per cent of all cancers diagnosed worldwide, disproportionately affecting some demographic groups, with an occurrence of less than 6 per 100,000 individuals annually. Many rare cancers in adults, adolescents and children are not curable, and patients and care providers have little option to take therapeutic decisions. The epidemiology of rare cancers is a challenging area of study but is inadequately addressed. Despite efforts mainly in some European nations, a few improvements have been observed in the management of rare cancers. Reasons for this obvious stagnation are multifactorial and are mainly inherent to logistical difficulties in carrying out clinical trials in very small patient populations, hesitation of the pharmaceutical industry to spend in small markets and complexity in creating adequate information for the development of cost-effective drugs. Rare cancers also face specific challenges that include late and incorrect diagnosis, lack of clinical expertise and lack of research interest and development of new therapies. The utilization of nationally representative study findings for the patients’ evaluation may possibly offer chances to find out pathogenesis and prevalence, and this will eventually lead to control and prevention. Currently, advancing targeted therapies offer a great opportunity for the better management of rare cancers. Conducting clinical trials with small patient population, innovative clinical trial approach, prevailing controlling obstacles for international cooperation and financial support for research are the present challenges for rare cancers. The International Rare Cancers Initiative functions as a main platform for achieving new international clinical trials in rare tumours. This review delineates the current challenges and issues in the interpretation, management and research scenarios of rare cancers. PMID:28574010

Ethical considerations in industry-sponsored multiregional clinical trials.

PubMed

Ibia, Ekopimo; Binkowitz, Bruce; Saillot, Jean-Louis; Talerico, Steven; Koerner, Chin; Ferreira, Irene; Agarwal, Anupam; Metz, Craig; Maman, Marianne

2010-01-01

During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider. Copyright © 2010 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.

Optimising a curriculum for clinical haematology and biochemistry in sports medicine: a Delphi approach

PubMed Central

Fallon, K E; Trevitt, A C

2006-01-01

Objectives To investigate issues of curriculum in the context of a postgraduate sports medicine training programme, specifically in the field of clinical biochemistry and haematology. Methods Following the Delphi methodology, a series of sequential questionnaires was administered to curriculum developers, clinical teachers, examiners, and registrars. Results Agreement on a core syllabus for this subject with an indication of the core aims and objectives of teaching and learning in this field and the associated required skills and competencies. An indication of current and ideal teaching and learning methods and reasons for these preferences. A consensus of key features of a teaching module for this field and of appropriate methods of examination. Conclusions The data derived from this study, as well as the experience of engaging in it, will better inform curriculum developers, teachers, and students of one another's perceptions as to what is important in and appropriate to teaching and learning in this field of sports medicine. Engagement in the exercise and broader consideration of the outcomes by those who develop the curriculum, teach, and formulate the examination process will facilitate attainment of the ideal of well aligned teaching, learning, and examination in this specific field. PMID:16432001

Parsing the phenotype of obsessive-compulsive tic disorder (OCTD): a multidisciplinary consensus.

PubMed

Dell'Osso, Bernardo; Marazziti, Donatella; Albert, Umberto; Pallanti, Stefano; Gambini, Orsola; Tundo, Antonio; Zanaboni, Carlotta; Servello, Domenico; Rizzo, Renata; Scalone, Luciana; Benatti, Beatrice; Altamura, A Carlo; Porta, Mauro

2017-06-01

Obsessive-Compulsive Disorder (OCD) and Tic Disorder (TD) are highly disabling and often comorbid conditions. Of note, the DSM-5 acknowledged a new 'tic-related' specifier for OCD, which might be referred to as Obsessive-Compulsive Tic Disorder (OCTD), raising new interest toward a better clinical characterisation of affected patients. Available literature indicates that early onset, male gender, sensory phenomena and obsessions of symmetry, aggressiveness, hoarding, exactness and sounds as well as comorbidity with Attention Deficit Hyperactivity Disorder (ADHD) may be of more frequent observation in patients with OCTD. In order to share expertise in the field from different perspectives, a multidisciplinary panel of Italian clinicians, specifically involved in the clinical care of OCD and TD patients, participated into a consensus initiative, aimed to produce a shared document. As a result, after having examined the most relevant literature, authors sought to critically identify and discuss main epidemiologic, socio-demographic and clinical features characterising OCTD patients, along with other specific aspects including Health-Related Quality-of-Life (HRQoL), economic consequences related with the condition and its management, as well as treatment-related issues, that need to be further investigated.

Switching long acting antipsychotic medications to aripiprazole long acting once-a-month: expert consensus by a panel of Italian and Spanish psychiatrists.

PubMed

Fagiolini, Andrea; Alfonsi, Emilia; Amodeo, Giovanni; Cenci, Mario; Di Lella, Michele; Farinella, Francesco; Ferraiuolo, Fabrizio; Fraguas, David; Loparco, Natale; Gutierrez-Rojas, Luis; Mignone, Maria Laura; Pataracchia, Giuseppe; Pillai, Gianluca; Russo, Felicia; Sanchez-Gistau, Vanessa; Spinogatti, Franco; Toscano, Marco; Villari, Vincenzo; De Filippis, Sergio

2016-01-01

Aripiprazole long acting once-monthly (AOM) is a long acting atypical antipsychotic with proven efficacy in schizophrenia and with a pharmacological and a side effect profile that is different from other antipsychotics. These and other characteristics make AOM a possible alternative in patients requiring a change in long acting antipsychotic treatment due to issues such as lack of efficacy or persistent side effects. Both clinical and pharmacological factors should be considered when switching antipsychotics, and specific guidelines for long acting antipsychotic switching that address all these factors are needed. A panel of Italian and Spanish experts in psychiatry met to discuss the strategies for the switch to AOM in patients with schizophrenia. Real life clinical experiences were shared and the clinical strategies to improve the likelihood of success were discussed. Due to its specific pharmacological and tolerability profile, AOM represents a suitable alternative for patients with schizophrenia requiring a switch to a new LAI treatment because of lack of efficacy or persistent side effects from another LAI. Possible strategies for the switch to AOM are presented in this expert consensus paper in an attempt to provide guidance throughout the entire switching process.

Incidence of Ganciclovir Resistance in CMV-positive Renal Transplant Recipients and its Association with UL97 Gene Mutations.

PubMed

Aslani, Hamid Reza; Ziaie, Shadi; Salamzadeh, Jamshid; Zaheri, Sara; Samadian, Fariba; Mastoor-Tehrani, Shayan

2017-01-01

Human cytomegalovirus (CMV) remains the most common infection affecting organ transplant recipients. Despite advances in the prophylaxis and acute treatment of CMV, it remains an important pathogen affecting the short- and long-term clinical outcome of solid organ transplant recipient. The emergence of CMV resistance in a patient reduces the clinical efficacy of antiviral therapy, complicates therapeutic and clinical management decisions, and in some cases results in loss of the allograft and/or death of the patient. Common mechanisms of CMV resistance to ganciclovir have been described chiefly with the UL97 mutations. Here we evaluate Incidence of ganciclovir resistance in 144 CMV-positive renal transplant recipients and its association with UL97 gene mutations. Active CMV infection was monitored by viral DNA quantification in whole blood, and CMV resistance was assessed by UL97 gene sequencing. Six mutations in six patients were detected. Three patients (2.6%) of 112 patients with history of ganciclovir (GCV) treatment had clinical resistance with single UL97 mutations at loci known to be related to resistance (including mutations at codon 594, codon 460, and codon 520). three patients who were anti-CMV drug naïve had single UL97 mutations (D605E) without clinical resistance. Our results confirm and extend our earlier findings on the specific mutations in the UL97 phosphotransferase gene in loci that have established role in ganciclovir resistance and also indicate that clinical ganciclovir resistance due to UL97 gene mutations is an issue in subjects with history of with ganciclovir treatment. D605E mutations remains a controversial issue that needs further investigations.

Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.

PubMed

Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice

2014-07-01

This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing. Copyright © 2014 Elsevier B.V. All rights reserved.

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.

Transparent Reporting of Data Quality in Distributed Data Networks

PubMed Central

Kahn, Michael G.; Brown, Jeffrey S.; Chun, Alein T.; Davidson, Bruce N.; Meeker, Daniella; Ryan, Patrick B.; Schilling, Lisa M.; Weiskopf, Nicole G.; Williams, Andrew E.; Zozus, Meredith Nahm

2015-01-01

Introduction: Poor data quality can be a serious threat to the validity and generalizability of clinical research findings. The growing availability of electronic administrative and clinical data is accompanied by a growing concern about the quality of these data for observational research and other analytic purposes. Currently, there are no widely accepted guidelines for reporting quality results that would enable investigators and consumers to independently determine if a data source is fit for use to support analytic inferences and reliable evidence generation. Model and Methods: We developed a conceptual model that captures the flow of data from data originator across successive data stewards and finally to the data consumer. This “data lifecycle” model illustrates how data quality issues can result in data being returned back to previous data custodians. We highlight the potential risks of poor data quality on clinical practice and research results. Because of the need to ensure transparent reporting of a data quality issues, we created a unifying data-quality reporting framework and a complementary set of 20 data-quality reporting recommendations for studies that use observational clinical and administrative data for secondary data analysis. We obtained stakeholder input on the perceived value of each recommendation by soliciting public comments via two face-to-face meetings of informatics and comparative-effectiveness investigators, through multiple public webinars targeted to the health services research community, and with an open access online wiki. Recommendations: Our recommendations propose reporting on both general and analysis-specific data quality features. The goals of these recommendations are to improve the reporting of data quality measures for studies that use observational clinical and administrative data, to ensure transparency and consistency in computing data quality measures, and to facilitate best practices and trust in the new clinical discoveries based on secondary use of observational data. PMID:25992385

Challenges With Research Contract Negotiations in Community-Based Cancer Research.

PubMed

Thompson, Michael A; Hurley, Patricia A; Faller, Bryan; Longinette, Jean; Richter, Katie; Stewart, Teresa L; Robert, Nicholas

2016-06-01

Community-based research programs face many barriers to participation in clinical trials. Although the majority of people with cancer are diagnosed and treated in the community setting, only roughly 3% are enrolled onto clinical trials. Research contract and budget negotiations have been consistently identified as time consuming and a barrier to participation in clinical trials. ASCO's Community Research Forum conducted a survey about specific challenges of research contract and budget negotiation processes in community-based research settings. The goal was to ultimately identify potential solutions to these barriers. A survey was distributed to 780 community-based physician investigators and research staff. The survey included questions to provide insight into contract and budget negotiation processes and perceptions about related barriers. A total of 77% of the 150 respondents acknowledged barriers in the process. Respondents most frequently identified budget-related issues (n = 133), inefficiencies in the process (n = 80), or legal review and negotiation issues (n = 70). Of the respondents, 44.1% indicated that contract research organizations made the contract negotiations process harder for their research program, and only 5% believed contract research organizations made the process easier. The contract negotiations process is perceived to be impeded by sponsors through underestimation of costs, lack of flexibility with the contract language, and excessive delays. Improving clinical trial activation processes and reducing inefficiencies would be beneficial to all interested stakeholders, including patients who may ultimately stand to benefit from participation in clinical trials. The following key recommendations were made: standardization of contracts and negotiation processes to promulgate transparency and efficiencies, improve sponsor processes to minimize burden on sites, create and promote use of contract templates and best practices, and provide education and consultation. Copyright © 2016 by American Society of Clinical Oncology.

The National Clinical Assessment Tool for Medical Students in the Emergency Department (NCAT-EM)

PubMed Central

Jung, Julianna; Franzen, Douglas; Lawson, Luan; Manthey, David; Tews, Matthew; Dubosh, Nicole; Fisher, Jonathan; Haughey, Marianne; House, Joseph B.; Trainor, Arleigh; Wald, David A.; Hiller, Katherine

2018-01-01

Introduction Clinical assessment of medical students in emergency medicine (EM) clerkships is a highly variable process that presents unique challenges and opportunities. Currently, clerkship directors use institution-specific tools with unproven validity and reliability that may or may not address competencies valued most highly in the EM setting. Standardization of assessment practices and development of a common, valid, specialty-specific tool would benefit EM educators and students. Methods A two-day national consensus conference was held in March 2016 in the Clerkship Directors in Emergency Medicine (CDEM) track at the Council of Residency Directors in Emergency Medicine (CORD) Academic Assembly in Nashville, TN. The goal of this conference was to standardize assessment practices and to create a national clinical assessment tool for use in EM clerkships across the country. Conference leaders synthesized the literature, articulated major themes and questions pertinent to clinical assessment of students in EM, clarified the issues, and outlined the consensus-building process prior to consensus-building activities. Results The first day of the conference was dedicated to developing consensus on these key themes in clinical assessment. The second day of the conference was dedicated to discussing and voting on proposed domains to be included in the national clinical assessment tool. A modified Delphi process was initiated after the conference to reconcile questions and items that did not reach an a priori level of consensus. Conclusion The final tool, the National Clinical Assessment Tool for Medical Students in Emergency Medicine (NCAT-EM) is presented here. PMID:29383058

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 3: The Clinical Guidelines.

PubMed

Fountoulakis, Konstantinos N; Grunze, Heinz; Vieta, Eduard; Young, Allan; Yatham, Lakshmi; Blier, Pierre; Kasper, Siegfried; Moeller, Hans Jurgen

2017-02-01

The current paper introduces the actual International College of Neuro-Psychopharmacology clinical guidelines for the treatment of bipolar disorder. The current clinical guidelines are based on evidence-based data, but they also intend to be clinically useful, while a rigid algorithm was developed on the basis of firm evidence alone. Monotherapy was prioritized over combination therapy. There are separate recommendations for each of the major phases of bipolar disorder expressed as a 5-step algorithm. The current International College of Neuro-Psychopharmacology clinical guidelines for the treatment of bipolar disorder are the most up-to-date guidance and are as evidence based as possible. They also include recommendations concerning the use of psychotherapeutic interventions, again on the basis of available evidence. This adherence of the workgroup to the evidence in a clinically oriented way helped to clarify the role of specific antidepressants and traditional agents like lithium, valproate, or carbamazepine. The additional focus on specific clinical characteristics, including predominant polarity, mixed features, and rapid cycling, is also a novel approach. Many issues need further studies, data are sparse and insufficient, and many questions remain unanswered. The most important and still unmet need is to merge all the guidelines that concern different phases of the illness into a single one and in this way consider BD as a single unified disorder, which is the real world fact. However, to date the research data do not permit such a unified approach. © The Author 2016. Published by Oxford University Press on behalf of CINP.

A detailed clinical analysis of 13 patients with AUTS2 syndrome further delineates the phenotypic spectrum and underscores the behavioural phenotype.

PubMed

Beunders, Gea; van de Kamp, Jiddeke; Vasudevan, Pradeep; Morton, Jenny; Smets, Katrien; Kleefstra, Tjitske; de Munnik, Sonja A; Schuurs-Hoeijmakers, Janneke; Ceulemans, Berten; Zollino, Marcella; Hoffjan, Sabine; Wieczorek, Stefan; So, Joyce; Mercer, Leanne; Walker, Tanya; Velsher, Lea; Parker, Michael J; Magee, Alex C; Elffers, Bart; Kooy, R Frank; Yntema, Helger G; Meijers-Heijboer, Elizabeth J; Sistermans, Erik A

2016-08-01

AUTS2 syndrome is an 'intellectual disability (ID) syndrome' caused by genomic rearrangements, deletions, intragenic duplications or mutations disrupting AUTS2. So far, 50 patients with AUTS2 syndrome have been described, but clinical data are limited and almost all cases involved young children. We present a detailed clinical description of 13 patients (including six adults) with AUTS2 syndrome who have a pathogenic mutation or deletion in AUTS2. All patients were systematically evaluated by the same clinical geneticist. All patients have borderline to severe ID/developmental delay, 83-100% have microcephaly and feeding difficulties. Congenital malformations are rare, but mild heart defects, contractures and genital malformations do occur. There are no major health issues in the adults; the oldest of whom is now 59 years of age. Behaviour is marked by it is a friendly outgoing social interaction. Specific features of autism (like obsessive behaviour) are seen frequently (83%), but classical autism was not diagnosed in any. A mild clinical phenotype is associated with a small in-frame 5' deletions, which are often inherited. Deletions and other mutations causing haploinsufficiency of the full-length AUTS2 transcript give a more severe phenotype and occur de novo. The 13 patients with AUTS2 syndrome with unique pathogenic deletions scattered around the AUTS2 locus confirm a phenotype-genotype correlation. Despite individual variations, AUTS2 syndrome emerges as a specific ID syndrome with microcephaly, feeding difficulties, dysmorphic features and a specific behavioural phenotype. 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/

Introduction: Applying Clinical Psychological Science to Practice.

PubMed

Cha, Christine B; DiVasto, Katherine A

2017-05-01

Mental illness is a prevalent and extraordinarily complex phenomenon. Psychologists have developed distinct approaches toward understanding and treating mental illness, rooted in divergent epistemology. This introduction to the Special Issue on Clinical Psychological Science and Practice provides a brief overview of the scientist-practitioner gap, and explores one step (of many) toward bridging this divide. Seven compelling case illustrations featured in this Special Issue apply empirical findings to case formulation, treatment selection, and assessment across complex and varied clinical presentations. This issue thereby demonstrates the feasibility of integrating research and clinical expertise in mental healthcare. © 2017 Wiley Periodicals, Inc.

Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations

PubMed Central

Hammerschlag, Richard; Mills, Paul; Cohen, Lorenzo; Krieger, Richard; Vieten, Cassandra; Lutgendorf, Susan

2015-01-01

Biofield therapies are noninvasive therapies in which the practitioner explicitly works with a client's biofield (interacting fields of energy and information that surround living systems) to stimulate healing responses in patients. While the practice of biofield therapies has existed in Eastern and Western cultures for thousands of years, empirical research on the effectiveness of biofield therapies is still relatively nascent. In this article, we provide a summary of the state of the evidence for biofield therapies for a number of different clinical conditions. We note specific methodological issues for research in biofield therapies that need to be addressed (including practitioner-based, outcomes-based, and research design considerations), as well as provide a list of suggested next steps for biofield researchers to consider. PMID:26665043

Blending quantitative and qualitative methods in language research and intervention.

PubMed

Brinton, Bonnie; Fujiki, Martin

2003-05-01

Best practice in speech-language pathology should be informed by current research findings. Traditional research methods are not always geared to address some of the complex, individual questions that arise in clinical intervention, however. Qualitative research methods may provide useful tools for bridging the gap from research to practice. Combinations of qualitative and quantitative procedures may be particularly helpful in sorting out some of the important issues surrounding language intervention in both clinical and research contexts. Examples of research blending qualitative and quantitative methods, as well as the case study of Sid, an 11-year-old boy with specific language impairment, are presented to illustrate how a combination of procedures can be used to enhance language research and intervention.

Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations.

PubMed

Jain, Shamini; Hammerschlag, Richard; Mills, Paul; Cohen, Lorenzo; Krieger, Richard; Vieten, Cassandra; Lutgendorf, Susan

2015-11-01

Biofield therapies are noninvasive therapies in which the practitioner explicitly works with a client's biofield (interacting fields of energy and information that surround living systems) to stimulate healing responses in patients. While the practice of biofield therapies has existed in Eastern and Western cultures for thousands of years, empirical research on the effectiveness of biofield therapies is still relatively nascent. In this article, we provide a summary of the state of the evidence for biofield therapies for a number of different clinical conditions. We note specific methodological issues for research in biofield therapies that need to be addressed (including practitioner-based, outcomes-based, and research design considerations), as well as provide a list of suggested next steps for biofield researchers to consider.

Translational informatics: an industry perspective.

PubMed

Cantor, Michael N

2012-01-01

Translational informatics (TI) is extremely important for the pharmaceutical industry, especially as the bar for regulatory approval of new medications is set higher and higher. This paper will explore three specific areas in the drug development lifecycle, from tools developed by precompetitive consortia to standardized clinical data collection to the effective delivery of medications using clinical decision support, in which TI has a major role to play. Advancing TI will require investment in new tools and algorithms, as well as ensuring that translational issues are addressed early in the design process of informatics projects, and also given higher weight in funding or publication decisions. Ultimately, the source of translational tools and differences between academia and industry are secondary, as long as they move towards the shared goal of improving health.

Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates.

PubMed

Dellson, P; Nilbert, M; Bendahl, P-O; Malmström, P; Carlsson, C

2011-07-01

Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials. © 2010 Blackwell Publishing Ltd.

Practice paper of the Academy of Nutrition and Dietetics abstract: ethical and legal issues of feeding and hydration.

PubMed

Schwartz, Denise Baird; Posthauer, Mary Ellen; O'Sullivan Maillet, Julie

2013-07-01

It is the position of the Academy of Nutrition and Dietetics that individuals have the right to request or refuse nutrition and hydration as medical treatment. Registered dietitians should work collaboratively as part of an interprofessional team to make recommendations on providing, withdrawing, or withholding nutrition and hydration in individual cases and serve as active members of institutional ethics committees. This practice paper provides a proactive, integrated, systematic process to implement the Academy's position. The position and practice papers should be used together to address the history and supporting information of ethical and legal issues of feeding and hydration identified by the Academy. Elements of collaborative ethical deliberation are provided for pediatrics and adults and in different conditions. The process of ethical deliberation is presented with the roles and responsibilities of the registered dietitian and the dietetic technician, registered. Understanding the importance and applying concepts dealing with cultural values and religious diversity is necessary to integrate clinical ethics into nutrition care. Incorporating screening for quality-of-life goals is essential before implementing the Nutrition Care Process and improving health literacy with individual interactions. Developing institution-specific policies and procedures is necessary to accelerate the practice change with artificial nutrition, clinical ethics, and quality improvement projects to determine best practice. This paper supports the "Position of the Academy of Nutrition and Dietetics: Ethical and Legal Issues of Feeding and Hydration" published in the June 2013 issue of the Journal of the Academy of Nutrition and Dietetics. Copyright © 2013 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

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.

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.

Oral desensitization for milk allergy in children: state of the art.

PubMed

Pajno, Giovanni B

2011-12-01

The purpose of this review is to research current evidence on cow's milk oral immunotherapy for the treatment of cow's milk allergy (CMA). The specific, active treatment for IgE-mediated food allergy included CMA, which is currently being investigated in human trials. Allergen-specific approaches include oral, sublingual and epicutaneous immunotherapy. Reports on oral immunotherapy (OIT) for the treatment of milk allergy have been more extensive and carried out mostly with native proteins. The aim of OIT with cow's milk is the achievement of desensitization or tolerance by patients suffering from CMA. Desensitization state can be achieved by approximately 36-92% of the children treated with specific immunotherapy; the rate of permanent tolerance is unknown. Longer duration of desensitization may result in permanent tolerance. The possibility of adverse events or reactions during OIT is quite frequent. Side-effects have been reported by patients in all published studies. OIT as an active treatment for CMA represents an emerging reality. Before this treatment can be used in clinical practice, additional studies are needed. Currently, many issues remain unanswered: severity and type of food allergy responsive to specific immunotherapy, degree of protection, 'shared schedules' of desensitization(s) in research settings and well established risk-to-benefit ratio. However the field of specific, active treatment of food allergy is poised for clinically important advances.

Policy and Administrative Issues for Large-Scale Clinical Interventions Following Disasters

PubMed Central

Cobham, Vanessa E.; McDermott, Brett

2014-01-01

Abstract Objective: Large, programmatic mental health intervention programs for children and adolescents following disasters have become increasingly common; however, little has been written about the key goals and challenges involved. Methods: Using available data and the authors' experiences, this article reviews the factors involved in planning and implementing large-scale treatment programs following disasters. Results: These issues include funding, administration, choice of clinical targets, workforce selection, choice of treatment modalities, training, outcome monitoring, and consumer uptake. Ten factors are suggested for choosing among treatment modalities: 1) reach (providing access to the greatest number), 2) retention of patients, 3) privacy, 4) parental involvement, 5) familiarity of the modality to clinicians, 6) intensity (intervention type matches symptom acuity and impairment of patient), 7) burden to the clinician (in terms of time, travel, and inconvenience), 8) cost, 9) technology needs, and 10) effect size. Traditionally, after every new disaster, local leaders who have never done so before have had to be recruited to design, administer, and implement programs. Conclusion: As expertise in all of these areas represents a gap for most local professionals in disaster-affected areas, we propose that a central, nongovernmental agency with national or international scope be created that can consult flexibly with local leaders following disasters on both overarching and specific issues. We propose recommendations and point out areas in greatest need of innovation. PMID:24521227

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.

Site-specific quantitative analysis of cardiac mitochondrial protein phosphorylation.

PubMed

Lam, Maggie P Y; Lau, Edward; Scruggs, Sarah B; Wang, Ding; Kim, Tae-Young; Liem, David A; Zhang, Jun; Ryan, Christopher M; Faull, Kym F; Ping, Peipei

2013-04-09

We report the development of a multiple-reaction monitoring (MRM) strategy specifically tailored to the detection and quantification of mitochondrial protein phosphorylation. We recently derived 68 MRM transitions specific to protein modifications in the respiratory chain, voltage-dependent anion channel, and adenine nucleotide translocase. Here, we have now expanded the total number of MRM transitions to 176 to cover proteins from the tricarboxylic acid cycle, pyruvate dehydrogenase complex, and branched-chain alpha-keto acid dehydrogenase complex. We utilized the transition set to analyze endogenous protein phosphorylation in human heart, mouse heart, and mouse liver. The data demonstrate the potential utility of the MRM workflow for studying the functional details of mitochondrial phosphorylation signaling. This article is part of a Special Issue entitled: From protein structures to clinical applications. Copyright © 2012 Elsevier B.V. All rights reserved.

Designing clinically valuable telehealth resources: processes to develop a community-based palliative care prototype.

PubMed

Tieman, Jennifer Joy; Morgan, Deidre Diane; Swetenham, Kate; To, Timothy Hong Man; Currow, David Christopher

2014-09-04

Changing population demography and patterns of disease are increasing demands on the health system. Telehealth is seen as providing a mechanism to support community-based care, thus reducing pressure on hospital services and supporting consumer preferences for care in the home. This study examined the processes involved in developing a prototype telehealth intervention to support palliative care patients involved with a palliative care service living in the community. The challenges and considerations in developing the palliative care telehealth prototype were reviewed against the Center for eHealth Research (CeHRes) framework, a telehealth development model. The project activities to develop the prototype were specifically mapped against the model's first four phases: multidisciplinary project management, contextual inquiry, value specification, and design. This project has been developed as part of the Telehealth in the Home: Aged and Palliative Care in South Australia initiative. Significant issues were identified and subsequently addressed during concept and prototype development. The CeHRes approach highlighted the implicit diversity in views and opinions among participants and stakeholders and enabled issues to be considered, resolved, and incorporated during design through continuous engagement. The CeHRes model provided a mechanism that facilitated "better" solutions in the development of the palliative care prototype by addressing the inherent but potentially unrecognized differences in values and beliefs of participants. This collaboration enabled greater interaction and exchange among participants resulting in a more useful and clinically valuable telehealth prototype.

Urine and oral fluid drug testing in support of pain management.

PubMed

Kwong, Tai C; Magnani, Barbarajean; Moore, Christine

2017-09-01

In recent years, the abuse of opioid drugs has resulted in greater prevalence of addiction, overdose, and deaths attributable to opioid abuse. The epidemic of opioid abuse has prompted professional and government agencies to issue practice guidelines for prescribing opioids to manage chronic pain. An important tool available to providers is the drug test for use in the initial assessment of patients for possible opioid therapy, subsequent monitoring of compliance, and documentation of suspected aberrant drug behaviors. This review discusses the issues that most affect the clinical utility of drug testing in chronic pain management with opioid therapy. It focuses on the two most commonly used specimen matrices in drug testing: urine and oral fluid. The advantages and disadvantages of urine and oral fluid in the entire testing process, from specimen collection and analytical methodologies to result interpretation are reviewed. The analytical sensitivity and specificity limitations of immunoassays used for testing are examined in detail to draw attention to how these shortcomings can affect result interpretation and influence clinical decision-making in pain management. The need for specific identification and quantitative measurement of the drugs and metabolites present to investigate suspected aberrant drug behavior or unexpected positive results is analyzed. Also presented are recent developments in optimization of test menus and testing strategies, such as the modification of the standard screen and reflexed-confirmation testing model by eliminating some of the initial immunoassay-based tests and proceeding directly to definitive testing by mass spectrometry assays.

A review of the ligands and related targeting strategies for active targeting of paclitaxel to tumours.

PubMed

Li, Juan; Wang, Fengshan; Sun, Deqing; Wang, Rongmei

2016-08-01

It has been 30 years since the discovery of the anti-tumour property of paclitaxel (PTX), which has been successfully applied in clinic for the treatment of carcinomas of the lungs, breast and ovarian. However, PTX is poorly soluble in water and has no targeting and selectivity to tumour tissue. Recent advances in active tumour targeting of PTX delivery vehicles have addressed some of the issues related to lack of solubility in water and non-specific toxicities associated with PTX. These PTX delivery vehicles are designed for active targeting to specific cancer cells by the addition of ligands for recognition by specific receptors/antigens on cancer cells. This article will focus on various ligands and related targeting strategies serving as potential tools for active targeting of PTX to tumour tissues, illustrating their use in different tumour models. This review also highlights the need of further studies on the discovery of receptors in different cells of specific organ and ligands with binding efficiency to these specific receptors.

The scientific legacy of Little Hans and Little Albert: future directions for research on specific phobias in youth.

PubMed

Ollendick, Thomas H; Muris, Peter

2015-01-01

We review issues associated with the phenomenology, etiology, assessment, and treatment of specific phobias in children and adolescents and provide suggestions for future research and clinical practice. In doing so, we highlight the early case studies of Little Hans and Little Albert and the advances that have been made following the publication of these seminal cases. In recent years, we have witnessed a deeper understanding of the etiology of specific phobias and developed a rich array of evidence-based assessments and treatments with which to address specific phobias in youth. Although much has been accomplished in this area of inquiry, we also note that much remains to be done before we can advance more fully our understanding, assessment, and treatment of specific phobias in youth. It will be important for future work to build more firmly on these developments and to better determine the moderators and mediators of change with our evidence-based treatments and to more vigorously pursue their dissemination in real-word settings.

The use of EORTC measures in daily clinical practice-A synopsis of a newly developed manual.

PubMed

Wintner, Lisa M; Sztankay, Monika; Aaronson, Neil; Bottomley, Andrew; Giesinger, Johannes M; Groenvold, Mogens; Petersen, Morten Aa; van de Poll-Franse, Lonneke; Velikova, Galina; Verdonck-de Leeuw, Irma; Holzner, Bernhard

2016-11-01

Cancer has increasingly become a chronic condition and the routine collection of patient-reported outcomes (PROs) like quality of life is widely recommended for clinical practice. Nonetheless, the successful implementation of PROs is still a major challenge, although common barriers to and facilitators of their beneficial use are well known. To support health care professionals and other stakeholders in the implementation of the EORTC PRO measures, the EORTC Quality of Life Group provides guidance on issues considered important for their use in daily clinical practice. Herein, we present an outline of the newly developed "'Manual for the use of EORTC measures in daily clinical practice", covering the following issues: * a rationale for using EORTC measures in routine care *selection of EORTC measures, timing of assessments, scoring and presentation of results * aspects of a strategic implementation * electronic data assessment and telemonitoring, and * further use of EORTC measures and ethical considerations. Next to an extensive overview of currently available literature, the manual specifically focuses on knowledge about EORTC measures to give evidence-based recommendations whenever possible and to encourage readers and end-users of EORTC measures to contribute to further needed high-quality research. The manual will be accessible on the EORTC Quality of Life Group website's homepage and will be periodically updated to take into account any new knowledge due to medical, technical, regulatory and scientific advances. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

Checklist content on a standardized patient assessment: an ex post facto review.

PubMed

Boulet, John R; van Zanten, Marta; de Champlain, André; Hawkins, Richard E; Peitzman, Steven J

2008-03-01

While checklists are often used to score standardized patient based clinical assessments, little research has focused on issues related to their development or the level of agreement with respect to the importance of specific items. Five physicians independently reviewed checklists from 11 simulation scenarios that were part of the former Educational Commission for Foreign Medical Graduate's Clinical Skills Assessment and classified the clinical appropriateness of each of the checklist items. Approximately 78% of the original checklist items were judged to be needed, or indicated, given the presenting complaint and the purpose of the assessment. Rater agreement was relatively poor with pairwise associations (Kappa coefficient) ranging from 0.09 to 0.29. However, when only consensus indicated items were included, there was little change in examinee scores, including their reliability over encounters. Although most checklist items in this sample were judged to be appropriate, some could potentially be eliminated, thereby minimizing the scoring burden placed on the standardized patients. Periodic review of checklist items, concentrating on their clinical importance, is warranted.

A component-based problem list subsystem for the HOLON testbed. Health Object Library Online.

PubMed Central

Law, V.; Goldberg, H. S.; Jones, P.; Safran, C.

1998-01-01

One of the deliverables of the HOLON (Health Object Library Online) project is the specification of a reference architecture for clinical information systems that facilitates the development of a variety of discrete, reusable software components. One of the challenges facing the HOLON consortium is determining what kinds of components can be made available in a library for developers of clinical information systems. To further explore the use of component architectures in the development of reusable clinical subsystems, we have incorporated ongoing work in the development of enterprise terminology services into a Problem List subsystem for the HOLON testbed. We have successfully implemented a set of components using CORBA (Common Object Request Broker Architecture) and Java distributed object technologies that provide a functional problem list application and UMLS-based "Problem Picker." Through this development, we have overcome a variety of obstacles characteristic of rapidly emerging technologies, and have identified architectural issues necessary to scale these components for use and reuse within an enterprise clinical information system. PMID:9929252

Effects of probiotic supplementation over 5 months on routine haematology and clinical chemistry measures in healthy active adults.

PubMed

Cox, A J; West, N P; Horn, P L; Lehtinen, M J; Koerbin, G; Pyne, D B; Lahtinen, S J; Fricker, P A; Cripps, A W

2014-11-01

Use of probiotic-containing foods and probiotic supplements is increasing; however, few studies document safety and tolerability in conjunction with defined clinical end points. This paper reports the effects of 150 days of supplementation with either a single- (Bifidobacterium animalis subsp. lactis Bl-04) or a double-strain (Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis Bi-07) probiotic on routine haematology and clinical chemistry measures in healthy active adults. Pre- to post-intervention changes in laboratory measures were determined and compared between supplement and placebo groups. Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention. Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges. These data provide evidence supporting the use of these probiotic supplements over a period of 5 months in healthy active adults without obvious safety or tolerability issues.

Shiny FHIR: An Integrated Framework Leveraging Shiny R and HL7 FHIR to Empower Standards-Based Clinical Data Applications.

PubMed

Hong, Na; Prodduturi, Naresh; Wang, Chen; Jiang, Guoqian

2017-01-01

In this study, we describe our efforts in building a clinical statistics and analysis application platform using an emerging clinical data standard, HL7 FHIR, and an open source web application framework, Shiny. We designed two primary workflows that integrate a series of R packages to enable both patient-centered and cohort-based interactive analyses. We leveraged Shiny with R to develop interactive interfaces on FHIR-based data and used ovarian cancer study datasets as a use case to implement a prototype. Specifically, we implemented patient index, patient-centered data report and analysis, and cohort analysis. The evaluation of our study was performed by testing the adaptability of the framework on two public FHIR servers. We identify common research requirements and current outstanding issues, and discuss future enhancement work of the current studies. Overall, our study demonstrated that it is feasible to use Shiny for implementing interactive analysis on FHIR-based standardized clinical data.

Mental representations of attachment in eating disorders: a pilot study using the Adult Attachment Interview.

PubMed

Barone, Lavinia; Guiducci, Valentina

2009-07-01

Mental representations of attachment in a sample of adults with Eating Disorders (ED) were assessed using the Adult Attachment Interview (AAI). Sixty subjects participated in the study: 30 non-clinical and 30 clinical. The results obtained showed a specific distribution of attachment patterns in the clinical sample: 10% Free/Autonomous (F), 47% Insecure-Dismissing (Ds), 17% Insecure-Entangled/Preoccupied (E) and about 26% disorganized (CC/U). The two samples differed in their attachment pattern distribution and were significantly different on some coding system scales. Further information was obtained by analyzing differences between the three ED subtypes considered (i.e. Anorexia Nervosa, Bulimia Nervosa and Binge Eating Disorder) and by investigating the differential role of the two parental figures in the definition of attachment representations. Results showed potential benefits in using the AAI coding system scales in addition to the main classifications in order to understand better the developmental issues involved in these disorders. Implications for developmental research and clinical nosology are discussed.

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

Regulatory considerations for clinical development of cancer vaccines.

PubMed

Heelan, Bridget Theresa

2014-01-01

Cancer vaccines are aimed at stimulating an immune response to tumor tissue. There is a high level of clinical activity in this rapidly advancing field with over 1,400 trials registered on Clincaltrials.gov. The recent approval of Sipuleucel-T which is the first cancer vaccine approved in the US and EU has encouraged developers in this field. In contrast to more established approaches for treating cancer such as chemotherapy, regulatory guidelines have been developed relatively recently for cancer vaccines. These guidelines advise on general clinical requirements. As there is an increase in innovative strategies with novel products, a 2-way dialog with regulators is recommended on a case-by-case basis to justify the clinical development plan, taking into account specific quality issues related to the product(s) in development. It is important that the rationale, background and justification for the planned development is convincing when interacting with the regulatory authorities, to enable drug developers and regulators to reach agreement.

Next-generation sequencing in the clinic: promises and challenges.

PubMed

Xuan, Jiekun; Yu, Ying; Qing, Tao; Guo, Lei; Shi, Leming

2013-11-01

The advent of next generation sequencing (NGS) technologies has revolutionized the field of genomics, enabling fast and cost-effective generation of genome-scale sequence data with exquisite resolution and accuracy. Over the past years, rapid technological advances led by academic institutions and companies have continued to broaden NGS applications from research to the clinic. A recent crop of discoveries have highlighted the medical impact of NGS technologies on Mendelian and complex diseases, particularly cancer. However, the ever-increasing pace of NGS adoption presents enormous challenges in terms of data processing, storage, management and interpretation as well as sequencing quality control, which hinder the translation from sequence data into clinical practice. In this review, we first summarize the technical characteristics and performance of current NGS platforms. We further highlight advances in the applications of NGS technologies towards the development of clinical diagnostics and therapeutics. Common issues in NGS workflows are also discussed to guide the selection of NGS platforms and pipelines for specific research purposes. Published by Elsevier Ireland Ltd.

A component-based problem list subsystem for the HOLON testbed. Health Object Library Online.

PubMed

Law, V; Goldberg, H S; Jones, P; Safran, C

1998-01-01

One of the deliverables of the HOLON (Health Object Library Online) project is the specification of a reference architecture for clinical information systems that facilitates the development of a variety of discrete, reusable software components. One of the challenges facing the HOLON consortium is determining what kinds of components can be made available in a library for developers of clinical information systems. To further explore the use of component architectures in the development of reusable clinical subsystems, we have incorporated ongoing work in the development of enterprise terminology services into a Problem List subsystem for the HOLON testbed. We have successfully implemented a set of components using CORBA (Common Object Request Broker Architecture) and Java distributed object technologies that provide a functional problem list application and UMLS-based "Problem Picker." Through this development, we have overcome a variety of obstacles characteristic of rapidly emerging technologies, and have identified architectural issues necessary to scale these components for use and reuse within an enterprise clinical information system.

Quantifying factors for the success of stratified medicine.

PubMed

Trusheim, Mark R; Burgess, Breon; Hu, Sean Xinghua; Long, Theresa; Averbuch, Steven D; Flynn, Aiden A; Lieftucht, Alfons; Mazumder, Abhijit; Milloy, Judy; Shaw, Peter M; Swank, David; Wang, Jian; Berndt, Ernst R; Goodsaid, Federico; Palmer, Michael C

2011-10-31

Co-developing a drug with a diagnostic to create a stratified medicine - a therapy that is targeted to a specific patient population on the basis of a clinical characteristic such as a biomarker that predicts treatment response - presents challenges for product developers, regulators, payers and physicians. With the aim of developing a shared framework and tools for addressing these challenges, here we present an analysis using data from case studies in oncology and Alzheimer's disease, coupled with integrated computational modelling of clinical outcomes and developer economic value, to quantify the effects of decisions related to key issues such as the design of clinical trials. This illustrates how such analyses can aid the coordination of diagnostic and drug development, and the selection of optimal development and commercialization strategies. It also illustrates the impact of the interplay of these factors on the economic feasibility of stratified medicine, which has important implications for public policy makers.

Transition to adult-oriented health care: perspectives of youth and adults with complex physical disabilities.

PubMed

Young, Nancy L; Barden, Wendy S; Mills, Wendy A; Burke, Tricia A; Law, Mary; Boydell, Katherine

2009-01-01

The transition to adulthood is extremely difficult for individuals with disabilities. We sought to explore the specific issue of transition to adult-oriented health care in a Canadian context. We conducted semi-structured individual interviews with 15 youth and 15 adults with cerebral palsy, spina bifida, and acquired brain injuries of childhood, and their parents (n = 30). Respondents discussed their health care services, their experience with clinical transition, and contributing factors. We analyzed the transcripts using qualitative methods. All participants identified challenges in transition, including: lack of access to health care; lack of professionals' knowledge; lack of information and uncertainty regarding the transition process. Two solutions were identified: early provision of detailed information and more extensive support throughout the clinical transition process. The challenges of clinical transition were universal. More extensive information and support is needed during transition to ensure an efficient move to appropriate adult-oriented health care.

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.

Clinical and Pharmaceutical Solutions through Analysis (CPSA BRASIL 2015): on the way to innovation - pharmaceutical/analytical technology, regulation and knowledge management.

PubMed

Needham, Shane; Yates, Nathan; Barrientos, Rafael; Steel, Martin; Lee, Mike

2015-12-01

Clinical and Pharmaceutical Solutions through Analysis, São Paulo, Brazil, 3-5 August 2015 The 2nd Annual Symposium on Clinical and Pharmaceutical Solutions through Analysis was held on 3-5 August 2015 at Club Transatlântico, São Paulo, Brazil. This annual meeting began in 2014 and was the first industry-led event in Brazil to focus on the specific needs of industry researchers while bringing together technology and regulators. The goal of CPSA is to provide an in-depth review of innovative technology and industry practices through open discussion of industry-related issues and needs. Education and specialized training are the foundation of all CPSA events. As the industry has evolved so has CPSA. The CPSA annual meeting thrived with high quality scientific content, open interaction from industry opinion leaders and a collegial environment.