Global Biology Research Program: Program plan

NASA Technical Reports Server (NTRS)

1983-01-01

Biological processes which play a dominant role in these cycles which transform and transfer much of this material throughout the biosphere are examined. A greater understanding of planetary biological processes as revealed by the interaction of the biota and the environment. The rationale, scope, research strategy, and research priorities of the global biology is presented.

Space Technology To Meet Future Needs.

ERIC Educational Resources Information Center

National Academy of Sciences - National Research Council, Washington, DC. Aeronautics and Space Engineering Board.

The thrust of this book is to indicate relative priorities of technology and the rationale for investment in United States space technology to meet future needs as assessed by the Committee on Advanced Space Technology. In part one, a discussion of potential mission sets is given, including: (1) "Mission Requirements for Space Transportation;…

Establishing a Global Radiation Oncology Collaboration in Education (GRaCE): Objectives and priorities.

PubMed

Turner, Sandra; Eriksen, Jesper G; Trotter, Theresa; Verfaillie, Christine; Benstead, Kim; Giuliani, Meredith; Poortmans, Philip; Holt, Tanya; Brennan, Sean; Pötter, Richard

2015-10-01

Representatives from countries and regions world-wide who have implemented modern competency-based radiation- or clinical oncology curricula for training medical specialists, met to determine the feasibility and value of an ongoing international collaboration. In this forum, educational leaders from the ESTRO School, encompassing many European countries adopting the ESTRO Core Curriculum, and clinician educators from Canada, Denmark, the United Kingdom, Australia and New Zealand considered the training and educational arrangements within their jurisdictions, identifying similarities and challenges between programs. Common areas of educational interest and need were defined, which included development of new competency statements and assessment tools, and the application of the latter. The group concluded that such an international cooperation, which might expand to include others with similar goals, would provide a valuable vehicle to ensure training program currency, through sharing of resources and expertise, and enhance high quality radiation oncology education. Potential projects for the Global Radiation Oncology Collaboration in Education (GRaCE) were agreed upon, as was a strategy designed to maintain momentum. This paper describes the rationale for establishing this collaboration, presents a comparative view of training in the jurisdictions represented, and reports early goals and priorities. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Space Shuttle food galley design concept

NASA Technical Reports Server (NTRS)

Heidelbaugh, N. D.; Smith, M. C.; Fischer, R.; Cooper, B.

1974-01-01

A food galley has been designed for the crew compartment of the NASA Space Shuttle Orbiter. The rationale for the definition of this design was based upon assignment of priorities to each functional element of the total food system. Principle priority categories were assigned in the following order: food quality, nutrition, food packaging, menu acceptance, meal preparation efficiency, total system weight, total system volume, and total power requirements. Hence, the galley was designed using an 'inside-out' approach which first considered the food and related biological functions and subsequently proceeded 'outward' from the food to encompass supporting hardware. The resulting galley is an optimal design incorporating appropriate priorities for trade-offs between biological and engineering constraints. This design approach is offered as a model for the design of life support systems.

Grand Designs! Analysing the Conceptual Tensions Associated with New Physical Education and Health and Well-Being Curriculum

ERIC Educational Resources Information Center

Thorburn, Malcolm; Horrell, Andrew

2014-01-01

The positioning of physical education in the school curriculum continues to reflect external discourses circulating in political and social milieu. As increasing austerity measures influence and restrict educational priorities, we consider that there is an urgent need for physical educationalists to articulate a rationale for an educational…

Integration of mental health into primary care and community health working in Kenya: context, rationale, coverage and sustainability.

PubMed

Jenkins, Rachel; Kiima, David; Okonji, Marx; Njenga, Frank; Kingora, James; Lock, Sarah

2010-03-01

Integration of mental health into primary care is essential to meet population needs yet faces many challenges if such projects are to achieve impact and be sustainable in low income countries alongside other competing priorities. This paper describes the rationale and progress of a collaborative project in Kenya to train primary care and community health workers about mental health and integrate mental health into their routine work, Within a health systems strengthening approach. So far 1877 health workers have been trained. The paper describes the multiple challenges faced by the project, and reviews the mechanisms deployed which have strengthened its impact and sustainability to date.

Introduction: priority setting, equitable access and public involvement in health care.

PubMed

Weale, Albert; Kieslich, Katharina; Littlejohns, Peter; Tugendhaft, Aviva; Tumilty, Emma; Weerasuriya, Krisantha; Whitty, Jennifer A

2016-08-15

Purpose - The purpose of this paper is to introduce the special issue on improving equitable access to health care through increased public and patient involvement (PPI) in prioritization decisions by discussing the conceptualization, scope and rationales of PPI in priority setting that inform the special issue. Design/methodology/approach - The paper employs a mixed-methods approach in that it provides a literature review and a conceptual discussion of the common themes emerging in the field of PPI and health priority setting. Findings - The special issue focuses on public participation that is collective in character, in the sense that the participation relates to a social, not personal, decision and is relevant to whole groups of people and not single individuals. It is aimed at influencing a decision on public policy or legal rules. The rationales for public participation can be found in democratic theory, especially as they relate to the social and political values of legitimacy and representation. Originality/value - The paper builds on previous definitions of public participation by underlining its collective character. In doing so, it develops the work by Parry, Moyser and Day by arguing that, in light of the empirical evidence presented in this issue, public participatory activities such as protests and demonstrations should no longer be labelled unconventional, but should instead be labelled as "contestatory participation". This is to better reflect a situation in which these modes of participation have become more conventional in many parts of the world.

Innovate Literacy Instruction with a Classroom Computer: A Solid Rationale for the Integration of Specific Digital Tools

ERIC Educational Resources Information Center

McAdams, Laurie

2013-01-01

The digital age has impacted education and how teachers prepare students to master 21st century literacies. Numerous national, state, and local entities have made the integration of technology into the literacy curriculum a priority, and teachers are becoming more proficient with their use of digital tools. However, integrating technology to…

Canadian College and Institute Federal Budget Priorities. ACCC Submission to the Standing Committee on Finance Pre-Budget Consultation.

ERIC Educational Resources Information Center

Association of Canadian Community Colleges.

In this report, the Canadian Community College Association (CCCA) offers its rationale for urging the government of Canada to increase transfer payments to the provinces in support of postsecondary education by $2 billion per annum, as well as making an additional increase in transfer payments that would contribute to the future expansion of…

The WHO evidence-informed guideline development process and implications for vitamin and mineral research priorities: symposium rationale and summary.

PubMed

Neufeld, Lynnette M; Jalal, Chowdhury S B; Peña-Rosas, Juan Pablo; Tovey, David; Lutter, Chessa K; Stoltzfus, Rebecca J; Habicht, Jean-Pierre

2013-09-01

The WHO evidence-informed guidelines provide recommendations to Member States and their partners on interventions with vitamins and minerals. Evidence gathered and synthesized through systematic reviews contributes to the development of these guidelines, a process that is dependent on the availability and quality of evidence. Although the guideline development process is stringently governed and supervised to maintain clarity and transparency, the lack of adequacy and specificity of available evidence poses limitations to the formulation of recommendations that can be easily applied for policy and program decision making in diverse contexts. The symposium created a space for dialogue among scientists and public health practitioners to improve the understanding of how evidence fulfills the needs and reflect on mechanisms by which policy and program guidance and priorities for research could be better informed by policy and program needs. Ultimately, programmatic success depends not only on identifying efficacious agents but ensuring effective delivery to those with the potential to respond. To do this, we must understand the rationale for recommending interventions, the biological pathways by which interventions work, delivery systems required to make efficacious interventions work, and other contextual factors that might limit or facilitate successful implementation.

The use of ECT and MST in treating depression.

PubMed

Allan, Charlotte L; Ebmeier, Klaus P

2011-10-01

Electroconvulsive therapy (ECT) has been used clinically since 1938. Its most common use is in the treatment of depression: first line treatment where rapid recovery is a priority, but more frequently as an effective treatment for patients who do not respond to pharmacological and psychological approaches. Whilst it is widely hailed as an effective treatment, concerns about its effect on cognition remain. The development of magnetic seizure therapy (MST) over the past decade has attempted to devise a therapy with comparable efficacy to ECT, but without the associated cognitive side effects. The rationale for this is that MST uses magnetic fields to induce seizures in the cortex, without electrical stimulation of brain structures involved with memory. MST has been used successfully in the treatment of depression, yet there is a dearth of literature in comparison with ECT. We present a systematic review of the literature on ECT (from 2009-2011) and MST (from 2001-2011).

An Official American Thoracic Society Statement: The Importance of Healthy Sleep. Recommendations and Future Priorities

PubMed Central

Mukherjee, Sutapa; Patel, Sanjay R.; Kales, Stefanos N.; Ayas, Najib T.; Strohl, Kingman P.; Gozal, David; Malhotra, Atul

2015-01-01

Rationale: Despite substantial public interest, few recommendations on the promotion of good sleep health exist to educate health care providers and the general public on the importance of sleep for overall health. Objectives: The aim of this American Thoracic Society (ATS) statement is to provide a review of the current scientific literature to assist health care providers, especially pulmonologists and sleep physicians, in making recommendations to patients and the general public about the importance of achieving good quality and adequate quantity of sleep. Methods: ATS members were invited, based on their expertise in sleep medicine, and their conclusions were based on both empirical evidence identified after comprehensive literature review and clinical experience. Main Results: We focus on sleep health in both children and adults, including the impact of occupation on sleep, the public health implications of drowsy driving, and the common sleep disorders of obstructive sleep apnea and insomnia. This ATS statement also delineates gaps in research and knowledge that should be addressed and lead to new focused research priorities to advance knowledge in sleep and sleep health. Conclusions: Good quality and quantity of sleep are essential for good health and overall quality of life; therefore a strong recommendation was made for the implementation of public education programs on the importance of sleep health. PMID:26075423

How might acupuncture work? A systematic review of physiologic rationales from clinical trials.

PubMed

Moffet, Howard H

2006-07-07

Scientific interest in acupuncture has led numerous investigators to conduct clinical trials to test the efficacy of acupuncture for various conditions, but the mechanisms underlying acupuncture are poorly understood. The author conducted a PubMed search to obtain a fair sample of acupuncture clinical trials published in English in 2005. Each article was reviewed for a physiologic rationale, as well as study objectives and outcomes, experimental and control interventions, country of origin, funding sources and journal type. Seventy-nine acupuncture clinical trials were identified. Twenty-six studies (33%) offered no physiologic rationale. Fifty-three studies (67%) posited a physiologic basis for acupuncture: 33 (62% of 53) proposed neurochemical mechanisms, 2 (4%) segmental nervous system effects, 6 (11%) autonomic nervous system regulation, 3 (6%) local effects, 5 (9%) effects on brain function and 5 (9%) other effects. No rationale was proposed for stroke; otherwise having a rationale was not associated with objective, positive or negative findings, means of intervention, country of origin, funding source or journal type. The dominant explanation for how acupuncture might work involves neurochemical responses and is not reported to be dependent on treatment objective, specific points, means or method of stimulation. Many acupuncture trials fail to offer a meaningful rationale, but proposing a rationale can help investigators to develop and test a causal hypothesis, choose an appropriate control and rule out placebo effects. Acupuncture may stimulate self-regulatory processes independent of the treatment objective, points, means or methods used; this would account for acupuncture's reported benefits in so many disparate pathologic conditions.

Advanced study of global oceanographic requirements for EOS A/B: Appendix volume

NASA Technical Reports Server (NTRS)

1972-01-01

Tables and graphs are presented for a review of oceanographic studies using satellite-borne instruments. The topics considered include sensor requirements, error analysis for wind determination from glitter pattern measurements, coverage frequency plots, ground station rise and set times, a technique for reduction and analysis of ocean spectral data, rationale for the selection of a 2 PM descending orbit, and a priority analysis.

Issues and priorities of medical education research in Asia.

PubMed

Majumder, M A A

2004-03-01

This article addresses the roles, issues, approaches, rationale, pitfalls, priorities and balance of research in medical education, particularly its "disarray" status in Asia. Research in medical education has influenced education in many ways. Most importantly, it provides legitimate evidences to stakeholders on which to make educational decisions. It also has a wider social impact on teaching practice and subsequent clinical practice. However, in Asia, medical educational research has not substantially influenced educational policy and medical practices. Moreover, it fails to receive comparable attention as in developed countries. A number of constraints that have hampered the development of educational research in Asia are identified: low socio-economic condition of the region; cultural and religious values and beliefs of the people; lack of congruence between the mission and vision of medical schools; leadership crisis; lack of financial resources; inadequate exposure to medical educational research in undergraduate training; lack of collaboration and commitment; and unforeseeable short-term outcome of medical education. The article concludes with some specific recommendations to strengthen research and to create a research culture in the region, including active leadership and commitment of the institutes/organisations, careful assessment and strategic settings of the priorities of medical educational research, establishment of a regional centre for medical education research, availability of financial resources, wider dissemination of research findings, collaboration with the developed countries and initiative to publish regional-based medical education journals, including electronic journals. Appropriate research environment and culture will enable stakeholders to obtain evidence-based information from educational research to increase the relevance, quality, cost-effectiveness and equity of medical education and practice in Asia.

Bankruptcy, product liability, and hazardous waste

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

Sterrett, S.B. Jr.

Bankruptcy does not serve the goals underlying product liability and hazardous waste laws, which are to discourage accidents and to compensate accident victims. The author contends that changes in the existing priority scheme could improve the situation by encouraging corporation to improve their compliance with product liability and hazardous waste laws. He discusses the efficiency rationale of existing laws, then describes the theoretical rationales for the bankruptcy and secured credit systems. His Superpriority Proposal creates two beneficial effects by subordinating voluntary creditors to involuntary creditors: (1) it reduces the extent to which corporate debtors can externalize actual product costs basedmore » on their probability of insolvency, and (2) it provides incentives for voluntary creditors to monitor for debtor misconduct and corporate debtors to reassure and persuade creditors.« less

Rationale and Study Protocol for a Multi-component Health Information Technology (HIT) Screening Tool for Depression and Post-traumatic Stress Disorder in the Primary Care Setting

PubMed Central

Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V.; Sorkin, Dara H.

2016-01-01

The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients’ mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers’ time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered-randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients’ primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and PTSD among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. PMID:27394385

Rationale and study protocol for a multi-component Health Information Technology (HIT) screening tool for depression and post-traumatic stress disorder in the primary care setting.

PubMed

Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V; Sorkin, Dara H

2016-09-01

The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients' mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers' time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression and other mental health disorders in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients' primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder (PTSD) among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. Copyright © 2016 Elsevier Inc. All rights reserved.

Burden of Disease Study and Priority Setting in Korea: an Ethical Perspective

PubMed Central

2016-01-01

When thinking about priority setting in access to healthcare resources, decision-making requires that cost-effectiveness is balanced against medical ethics. The burden of disease has emerged as an important approach to the assessment of health needs for political decision-making. However, the disability adjusted life years approach hides conceptual and methodological issues regarding the claims and value of disabled people. In this article, we discuss ethical issues that are raised as a consequence of the introduction of evidence-based health policy, such as economic evidence, in establishing resource allocation priorities. In terms of ethical values in health priority setting in Korea, there is no reliable rationale for the judgment used in decision-making as well as for setting separate and distinct priorities for different government bodies. An important question, therefore, is which ethical values guiding the practice of decision-making should be reconciled with the economic evidence found in Korean healthcare. The health technology assessment core model from the European network for Health Technology Assessment (EUnetHTA) project is a good example of incorporating ethical values into decision-making. We suggest that a fair distribution of scarce healthcare resources in South Korea can be achieved by considering the ethical aspects of healthcare. PMID:27775247

Clinical Diagnosis of Dental Caries in the 21st Century: Introductory Paper - ORCA Saturday Afternoon Symposium, 2016.

PubMed

Machiulskiene, Vita; Carvalho, Joana Christina

2018-03-05

Classifications employed to measure dental caries should first of all reflect the dynamics of the disease, in order to provide a solid basis for subsequent treatment decisions and for further monitoring of dental health of individual patients and populations. The contemporary philosophy of dental caries management implies that nonoperative treatment of caries lesions should be implemented whenever possible, limiting operative interventions to the severe and irreversible cases. The ORCA Saturday Afternoon Symposium 2016, held back-to-back to the 63rd ORCA Congress in Athens, Greece, was intended to provide an update on general requirements for clinical caries diagnosis and to overview caries diagnostic classifications including their rationale, validation, advantages, and limitations. Clinical caries diagnostic criteria and caries management outcomes are interrelated, and any diagnostic classification disregarding this concept is outdated, according to the current understanding of oral health care. Choosing clinical caries diagnostic classifications that assess the activity status of detected lesions should be a priority for dental professionals since these classifications favor the best clinical practice directed towards nonoperative interventions. The choice of clinical caries diagnostic classifications in research, in clinical practice, and in public health services should be guided by the best available scientific evidence. The clinical caries diagnostic classifications should be universally applicable in all these fields. Policy making in oral health care and the underlying policy analyses should follow the same standards. Any clinical caries diagnostic classification disregarding the universality of its use is of limited or no interest in the context of the clinical caries diagnosis of today. © 2018 S. Karger AG, Basel.

From school to work: promoting the application of pre-qualification interprofessional education in the clinical workplace.

PubMed

Murray-Davis, Beth; Marshall, Michelle; Gordon, Frances

2012-09-01

The rationale for Interprofessional Education (IPE) is based on the assumption it will improve practice. Despite evidence that it may modify attitudes and provide knowledge and skills for collaboration, there is little evidence about whether these skills can be transferred to practice. The aim of this research was to explore how midwifery students apply pre-qualification IPE learning to practice and to understand the factors in the clinical workplace that facilitate or hinder this application. A purposive sample of students, educators, Heads of Midwifery and new midwives from four universities throughout the United Kingdom participated in semi-structured interviews and focus groups. Emerging themes were developed using the principles of Grounded Theory. Participants articulated ways in which the clinical environment either promoted or prevented IPE in practice. The extent to which the clinical institution promoted IPE was made visible through the support for students during placements; the support for new midwives; and the evolution of professional roles. Buy-in for the IPE agenda in the workplace influences the ability of new midwives to apply IPE competencies to professional practice. The benefits of a theoretical foundation in interprofessional skills may be lost if students and new midwives find themselves working in contexts that do not make collaboration a priority. Copyright © 2011 Elsevier Ltd. All rights reserved.

AYURVEDA, AN APPROPRIATE STRATEGY FOR SOCIAL HEALTH: An overview of the Indian Panorama

PubMed Central

Bijoy, C. R.

1981-01-01

The rationale for the thought of an appropriate strategy for social health, issues from the failiure to provide health with social Justice. Too much has been said and done along a devious path by the dominant class, that, increasing marginal rate of disutility threatens the very existence of man. A modest attempt has been made here to expose the corrosion in values and priorities and as to what little should and could be done to safeguard the right to health of underprivileged mass, in the light of the lack of political will and the rise of ‘elitism’ among the responsible people, the social relevance and the natural direction of progress consistent with the values and priorities of Ayurveda as a holistic system of health. PMID:22556469

AYURVEDA, AN APPROPRIATE STRATEGY FOR SOCIAL HEALTH: An overview of the Indian Panorama.

PubMed

Bijoy, C R

1981-10-01

The rationale for the thought of an appropriate strategy for social health, issues from the failiure to provide health with social Justice. Too much has been said and done along a devious path by the dominant class, that, increasing marginal rate of disutility threatens the very existence of man. A modest attempt has been made here to expose the corrosion in values and priorities and as to what little should and could be done to safeguard the right to health of underprivileged mass, in the light of the lack of political will and the rise of 'elitism' among the responsible people, the social relevance and the natural direction of progress consistent with the values and priorities of Ayurveda as a holistic system of health.

Cognitive Defusion versus Thought Distraction: A Clinical Rationale, Training, and Experiential Exercise in Altering Psychological Impacts of Negative Self-Referential Thoughts

ERIC Educational Resources Information Center

Masuda, Akihiko; Feinstein, Amanda B.; Wendell, Johanna W.; Sheehan, Shawn T.

2010-01-01

Using two modes of intervention delivery, the present study compared the effects of a cognitive defusion strategy with a thought distraction strategy on the emotional discomfort and believability of negative self-referential thoughts. One mode of intervention delivery consisted of a clinical rationale and training (i.e., Partial condition). The…

Prioritizing equipment for replacement.

PubMed

Capuano, Mike

2010-01-01

It is suggested that clinical engineers take the lead in formulating evaluation processes to recommend equipment replacement. Their skill, knowledge, and experience, combined with access to equipment databases, make them a logical choice. Based on ideas from Fennigkoh's scheme, elements such as age, vendor support, accumulated maintenance cost, and function/risk were used.6 Other more subjective criteria such as cost benefits and efficacy of newer technology were not used. The element of downtime was also omitted due to the data element not being available. The resulting Periop Master Equipment List and its rationale was presented to the Perioperative Services Program Council. They deemed the criteria to be robust and provided overwhelming acceptance of the list. It was quickly put to use to estimate required capital funding, justify items already thought to need replacement, and identify high-priority ranked items for replacement. Incorporating prioritization criteria into an existing equipment database would be ideal. Some commercially available systems do have the basic elements of this. Maintaining replacement data can be labor-intensive regardless of the method used. There is usually little time to perform the tasks necessary for prioritizing equipment. However, where appropriate, a clinical engineering department might be able to conduct such an exercise as shown in the following case study.

The future for blood-stage vaccines against malaria.

PubMed

Richards, Jack S; Beeson, James G

2009-07-01

Malaria is a leading cause of mortality and morbidity globally, and effective vaccines are urgently needed. Malaria vaccine approaches can be broadly grouped as pre-erythrocytic, blood stage and transmission blocking. This review focuses on blood-stage vaccines, and considers the evidence supporting the development of blood-stage vaccines, the advantages and challenges of this approach, potential targets, human vaccine studies and future directions. There is a strong rationale for the development of vaccines based on antigens of blood-stage parasites. Symptomatic malaria is caused by blood-stage parasitemia and acquired immunity in humans largely targets blood-stage antigens. Several candidate vaccines have proved efficacious in animal models and at least one vaccine showed partial efficacy in a clinical trial. At present, all leading candidate blood-stage antigens are merozoite proteins, located on the merozoite surface or within the apical organelles. Major challenges and priorities include overcoming antigenic diversity, identification of protective epitopes, understanding the nature and targets of protective immune responses, and defining antigen combinations that give the greatest efficacy. Additionally, objective criteria and approaches are needed to prioritize the large number of candidate antigens, and strong candidates need to be tested in clinical trials as quickly as possible.

Palliative Care in Heart Failure: Rationale, Evidence, and Future Priorities.

PubMed

Kavalieratos, Dio; Gelfman, Laura P; Tycon, Laura E; Riegel, Barbara; Bekelman, David B; Ikejiani, Dara Z; Goldstein, Nathan; Kimmel, Stephen E; Bakitas, Marie A; Arnold, Robert M

2017-10-10

Patients with heart failure (HF) and their families experience stress and suffering from a variety of sources over the course of the HF experience. Palliative care is an interdisciplinary service and an overall approach to care that improves quality of life and alleviates suffering for those living with serious illness, regardless of prognosis. In this review, we synthesize the evidence from randomized clinical trials of palliative care interventions in HF. While the evidence base for palliative care in HF is promising, it is still in its infancy and requires additional high-quality, methodologically sound studies to clearly elucidate the role of palliative care for patients and families living with the burdens of HF. Yet, an increase in attention to primary palliative care (e.g., basic physical and emotional symptom management, advance care planning), provided by primary care and cardiology clinicians, may be a vehicle to address unmet palliative needs earlier and throughout the illness course. Published by Elsevier Inc.

Future Directions in Painful Knee Osteoarthritis: Harnessing Complexity in a Heterogeneous Population

PubMed Central

George, Steven Z.; Maluf, Katrina S.; Stevens-Lapsley, Jennifer E.

2014-01-01

This perspective article proposes a conceptual model for the pain experience for individuals diagnosed with knee osteoarthritis (OA). Pain in knee OA is likely a heterogeneous, multifactorial phenomenon that involves not only the OA disease process but also elements specific to patient psychology and pain neurophysiology. The relevant contributions to the pain experience for any individual patient remain difficult, if not impossible, to definitively determine, and the rationale for many clinical treatment decisions arises primarily from a mechanistic understanding of OA pathophysiology. The Osteoarthritis Research Society International (OARSI) recently identified “phenotyping” of OA pain as a research priority to “better target pain therapies to individual patients.” This perspective article proposes that contributions from 3 domains—knee pathology, psychological distress, and pain neurophysiology—should be considered equally important in future efforts to understand pain phenotypes in knee OA. Ultimately, characterization of pain phenotypes may aid in the understanding of the pain experience and the development of interventions specific to pain for individual patients. PMID:24179141

Constructing a Global Learning Partnership in Physiotherapy: An Ireland-Uganda Initiative.

PubMed

O'Sullivan, Cliona; Kazibwe, Herman; Whitehouse, Zillah; Blake, Catherine

2017-01-01

There is a strong correlation between disability and poverty and it is acknowledged that until disability issues are addressed, the goal of poverty reduction in low-income countries is unlikely to be achieved. Despite the high prevalence of disability in developing countries, there remains a significant shortage of rehabilitation professionals as highlighted by the WHO report, Human resources for Health (2006). The purpose of this project was to develop a collaborative and sustainable partnership to strengthen educational and research capacity in global health, disability, and rehabilitation between two physiotherapy schools; University College Dublin, Ireland, and Mbarara University of Science and Technology, Uganda. This article aims to describe the approach used and initial project outcomes. This project involved a bilateral visit to both institutions by two members of staff of respective physiotherapy programs. These visits entailed stakeholder meetings, clinical site visits, and workshops to identify the priorities for the partnership and shape the collaboration going forward. Appreciative inquiry methodology was used during the workshops and the four-dimensional framework for curriculum development was used to guide analysis and underpin findings. The key priorities identified were (i) development of joint global health learning initiative, (ii) to explore the possibility of postgraduate learning and research opportunities for Ugandan colleagues, and (iii) to develop joint clinical placements. The rationale and context and a plan of action is described. The project is ambitious and in order to be sustainable, the importance of long-term interinstitutional commitment and further funding cannot be ignored. This work provides a framework for other universities and institutions wishing to undertake similar activities. Such partnerships provide rich learning opportunities for students and health professionals and facilitate a deeper understanding of global health issues, social and cultural health determinants, and development of enhanced professional skills.

Energetic rationale for an unexpected and abrupt reversal of guanidinium chloride-induced unfolding of peptide deformylase.

PubMed

Berg, Alexander K; Manokaran, Sumathra; Eiler, Daniel; Kooren, Joel; Mallik, Sanku; Srivastava, D K

2008-01-01

Peptide deformylase (PDF) catalyzes the removal of formyl group from the N-terminal methionine residues of nascent proteins in prokaryotes, and this enzyme is a high priority target for antibiotic design. In pursuit of delineating the structural-functional features of Escherichia coli PDF (EcPDF), we investigated the mechanistic pathway for the guanidinium chloride (GdmCl)-induced unfolding of the enzyme by monitoring the secondary structural changes via CD spectroscopy. The experimental data revealed that EcPDF is a highly stable enzyme, and it undergoes slow denaturation in the presence of varying concentrations of GdmCl. The most interesting aspect of these studies has been the abrupt reversal of the unfolding pathway at low to moderate concentrations of the denaturant, but not at high concentration. An energetic rationale for such an unprecedented feature in protein chemistry is offered.

Education scholarship in emergency medicine part 1: innovating and improving teaching and learning.

PubMed

Sherbino, Jonathan; Van Melle, Elaine; Bandiera, Glen; McEwen, Jill; Leblanc, Constance; Bhanji, Farhan; Frank, Jason R; Regehr, Glenn; Snell, Linda

2014-05-01

As emergency medicine (EM) education evolves, a more advanced understanding of education scholarship is required. This article is the first in a series of three articles that reports the recommendations of the 2013 education scholarship consensus conference of the Academic Section of the Canadian Association of Emergency Physicians. Adopting the Canadian Association for Medical Education's definition, education scholarship (including both research and innovation) is defined. A rationale for why education scholarship should be a priority for EM is discussed.

Rationale for treating hepatitis C virus infection in patients with mild to moderate chronic kidney disease.

PubMed

Ridruejo, Ezequiel; Mendizabal, Manuel; Silva, Marcelo O

2018-04-01

Hepatitis C virus infection (HCV) is highly prevalent in patients with chronic kidney disease (CKD) and kidney transplant recipients. Little information exists on treatment in patients with CKD stages 2 to 3, where CKD progression might be slowed by HCV treatment. These patients are not considered a high priority for HCV treatment in most international guidelines. Although some recently published guidelines propose universal treatment, others are still recommending it only in high priority groups. In this review, we evaluate current evidence of HCV infection impact on CKD progression, on cardiovascular and metabolic risk, and the benefits of HCV infection treatment to improve cardiovascular and metabolic outcomes. We made special focus on the benefits of HCV infection treatment in patients with stages 2 to 3 CKD to avoid CKD progression. © 2018 International Society for Hemodialysis.

Cognitive defusion versus thought distraction: a clinical rationale, training, and experiential exercise in altering psychological impacts of negative self-referential thoughts.

PubMed

Masuda, Akihiko; Feinstein, Amanda B; Wendell, Johanna W; Sheehan, Shawn T

2010-11-01

Using two modes of intervention delivery, the present study compared the effects of a cognitive defusion strategy with a thought distraction strategy on the emotional discomfort and believability of negative self-referential thoughts. One mode of intervention delivery consisted of a clinical rationale and training (i.e., Partial condition). The other mode contained a condition-specific experiential exercise with the negative self-referential thought in addition to the clinical rationale and training (i.e., Full condition). Nonclinical undergraduates were randomly assigned to one of five protocols: Partial-Defusion, Full-Defusion, Partial-Distraction, Full-Distraction, and a distraction-based experimental control task. The Full-Defusion condition reduced the emotional discomfort and believability of negative self-referential thoughts significantly more than other comparison conditions. The positive results of the Full-Defusion condition were also found among participants with elevated depressive symptoms.

International environmental health: priorities from Huairou.

PubMed

Rossignol, A M; Neumann, C

1998-01-01

Between August 30 and September 8, 1995, 38,000 women and several hundred men met in Huairou, China, to discuss the global status of women and to lobby for specific wording in the Agenda for Women that was being finalized in Beijing as part of the United Nations Fourth World Conference on Women. This article has two main objectives. The first objective is to summarize the priority concerns identified in Huairou that are related to international environmental health, especially concerns related to women. The second objective is to provide the rationale and documentation that support including these topics as part of professional education and practice in environmental health in the United States. It is hoped that this discussion will aid environmental health professionals in better appreciating the connection between global environmental health problems and local problems and the applicability of gender-relevant environmental health concerns to local programming, policies, and infrastructure.

Priority setting in clinical nursing practice: literature review.

PubMed

Hendry, Charles; Walker, Anne

2004-08-01

Time is a valuable resource. When nurses experience demands on their services which exceed their available time, then 'rationing' must occur. In clinical practice such rationing requires practitioners to set priorities for care. The aim of this paper is establish what is currently known about priority setting in nursing, including how nurses set priorities and what factors influence this. CINAHL, Medline, ASSIA, and PsychLit databases for the years 1982-2002 were searched, using the terms (clinical decision-making or problem-solving or planning) and (setting priorities or prioriti*). The publications found were used in a selective, descriptive review. Priority setting is an important skill in nursing, and a skill deficit can have serious consequences for patients. Recent studies have suggested that it is a difficult skill for newly qualified nurses to acquire and may not be given sufficient attention in nurse education. Priority setting can be defined as the ordering of nursing problems using notions of urgency and/or importance, in order to establish a preferential order for nursing actions. A number of factors that may impact on priority setting have been identified in the literature. These include: the expertise of the nurse; the patient's condition; the availability of resources; ward organization; philosophies and models of care; the nurse-patient relationship; and the cognitive strategy used by the nurse to set priorities. However, very little empirical work has been conducted in this area. Further study of priority setting in a range of clinical practice settings is necessary. This could inform both practice and education, promote better use of limited resources and maximize patient outcomes.

Benefits Innovations in Employee Behavioral Health.

PubMed

Sherman, Bruce; Block, Lori

2017-01-01

More and more employers recognize the business impact of behavioral health concerns in the workplace. This article provides insights into some of the current innovations in behavioral health benefits, along with their rationale for development. Areas of innovation include conceptual and delivery models, technological advance- ments, tools for engaging employees and ways of quantifying the business value of behavioral health benefits. The rapid growth of innovative behavioral health services should provide employers with confidence that they can tailor a program best suited to their priorities, organizational culture and cost limitations.

[Rationale for differentiated sanitary protection zones for battery recycling enterprises in modern conditions].

PubMed

Pinigin, M A; Popov, B A; Sabirova, Z F; Budarina, O V; Ul'ianova, A V

2013-01-01

In the paper there is presented the rationale for differentiated sanitary protective zones in the present conditions both of the increase of volumes of production and introduction of various technological solutions on the example of battery recycling enterprise. It is established that the in acting regulations the classification of enterprises recycling of non-ferrous metals, fails to take into account such the hazard risks criteria of the enterprise, as volume of emissions of priority substances, the height of their arrival in the atmosphere, etc., and also does not take into account increased significantly in the current time processing volumes. The results of the performed research allowed to offer new positions in the classification of production of secondary lead from used batteries (I to IV class), depending on the volume of production (from 20 000 to 160 000 tons per year), the amount of emissions of lead (0.2 to 1, 6 tons per year) and release height (15 to 60 m).

Developing nursing and midwifery research priorities: a Health Service Executive (HSE) North West study.

PubMed

Parlour, Randal; Slater, Paul

2014-06-01

The primary purpose of this study was to identify research priorities for nurses and midwives across the Health Service Executive (HSE) North West region. The rationale for the study was underlined during meetings of HSE North West Directors of Nursing and Midwifery in January 2011. It was agreed that a more strategic approach to generating synergy among nursing and midwifery research, evaluation, and evidence-based practice should be developed through the Nursing and Midwifery Planning and Development Unit. The research design was founded upon collaborative processes for consensus building that included the Delphi technique and nominal group technique. The study sample included a panel of experts. Data were collected between March 2011 and December 2011. Findings from this study validate the efficacy of the research methodology in enabling the effective identification of priority areas for research. These include: (a) an evaluation of the impact of postgraduate nursing and midwifery education programs focusing upon patient, professional, and organizational outcomes; (b) development and evaluation of an effective culture of nurse- and midwife-led audit across all services within a Regional Health Trust in Ireland; (c) an examination of the efficacy of approaches to clinical supervision within the context of the Irish health system; (d) an evaluation of the impact of an Advanced Nurse Practitioner role in supporting the effective management of long-term conditions within the context of Regional Health Trust primary care settings in Ireland; and (e) Supporting and developing an ethical framework for nursing and midwifery research within a Regional Health Trust in Ireland. It is anticipated that future work, outlined within this paper, will lead to important improvements in patient care and outcomes. Furthermore, this study provides evidence that a strong nursing and midwifery research agenda can be established upon genuine collaborations and partnerships across varying levels of research knowledge and skills, but with a shared purpose and shared values. © 2014 Sigma Theta Tau International.

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

Bekelman, Justin E., E-mail: bekelman@uphs.upenn.edu; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania

Purpose: To present the principles and rationale of the Proton Priority System (PROPS), a priority points framework that assigns higher scores to patients thought to more likely benefit from proton therapy, and the distribution of PROPS scores by patient characteristics Methods and Materials: We performed multivariable logistic regression to evaluate the association between PROPS scores and receipt of proton therapy, adjusted for insurance status, gender, race, geography, and the domains that inform the PROPS score. Results: Among 1529 adult patients considered for proton therapy prioritization during our Center's ramp-up phase of treatment availability, PROPS scores varied by age, diagnosis, site,more » and other PROPS domains. In adjusted analyses, receipt of proton therapy was lower for patients with non-Medicare relative to Medicare health insurance (commercial vs Medicare: adjusted odds ratio [OR] 0.47, 95% confidence interval [CI] 0.34-0.64; managed care vs Medicare: OR 0.40, 95% CI 0.28-0.56; Medicaid vs Medicare: OR 0.24, 95% CI 0.13-0.44). Proton Priority System score and age were not significantly associated with receipt of proton therapy. Conclusions: The Proton Priority System is a rationally designed and transparent system for allocation of proton therapy slots based on the best available evidence and expert opinion. Because the actual allocation of treatment slots depends mostly on insurance status, payers may consider incorporating PROPS, or its underlying principles, into proton therapy coverage policies.« less

Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS): Rationale, Design, and Methods

ERIC Educational Resources Information Center

McClellan, Jon; Sikich, Linmarie; Findling, Robert L.; Frazier, Jean A.; Vitiello, Benedetto; Hlastala, Stefanie A.; Williams, Emily; Ambler, Denisse; Hunt-Harrison, Tyehimba; Maloney, Ann E.; Ritz, Louise; Anderson, Robert; Hamer, Robert M.; Lieberman, Jeffrey A.

2007-01-01

Objective: The Treatment of Early Onset Schizophrenia Spectrum Disorders Study is a publicly funded clinical trial designed to compare the therapeutic benefits, safety, and tolerability of risperidone, olanzapine, and molindone in youths with early-onset schizophrenia spectrum disorders. The rationale, design, and methods of the Treatment of Early…

Assessing the extent to which current clinical research is consistent with patient priorities: a scoping review using a case study in patients on or nearing dialysis.

PubMed

Jun, Min; Manns, Braden; Laupacis, Andreas; Manns, Liam; Rehal, Bhavdeep; Crowe, Sally; Hemmelgarn, Brenda R

2015-01-01

There is growing acknowledgement that engaging patients to identify their research priorities is important. Using a case study of patients on or nearing dialysis, we sought to assess the extent to which recently completed and ongoing clinical research was consistent with priorities identified by patients, caregivers, and clinicians. Over a 4-year sampling frame (January 2010 to December 2013), we systematically searched the medical literature (top 5 nephrology and top 10 general medicine journals accessed through MEDLINE via Ovid), international randomized controlled trial (RCT) registries, and national government and kidney research funding organizations (Canada, U.S., Australia, and U.K.) for published clinical studies, registered RCTs, and funded clinical studies, respectively. Published clinical studies, registered RCTs, and funded clinical studies were categorized as to whether or not they were consistent with the top 10 research priorities identified by patients, their caregivers, and clinicians in a recent comprehensive research priority setting exercise. The search yielded 4293 published articles, 688 RCTs, and 70 funded studies, of which 1116 articles, 315 RCTs, and 70 funded studies were eligible for inclusion. Overall 194 published studies (17.4 %), 71 RCTs (22.5 %), and 15 funded studies (21.4 %) included topics consistent with the top 10 research priorities identified by patients. Four of the top 10 research priorities, including strategies to improve the management of itching, increase access to kidney transplantation, assess the psychosocial impact of kidney failure, and determine the effects of dietary restriction received virtually no attention. The top 10 priorities we used to categorize included studies were identified by Canadian patients, caregivers, and clinicians. The top research priorities may vary across different countries. The proportion of published studies that are consistent with the top 10 priorities could be different in nephrology journals with lower impact factors. Studies related to kidney transplantation and the psychosocial impact of kidney failure may have been published in journals not included in our search strategy. The majority of recently completed or ongoing clinical studies in patients on or nearing dialysis do not address the top research priorities of patients, raising concerns that current clinical research may not be meeting the needs of the ultimate consumer, in this case, patients on or nearing dialysis. Greater involvement of patients in research is required to bridge the gap between research and patients' needs.

Improving the quality of healthcare for children: implementing the results of the AHSR research agenda conference.

PubMed Central

Halfon, N; Schuster, M; Valentine, W; McGlynn, E

1998-01-01

OBJECTIVE: To describe the rationale, development, content, and results of the AHSR-sponsored conference on developing a research agenda focused on improving the quality of care for children. DATA SOURCES AND METHODS: Planning documents, background papers, and conference proceedings. PRINCIPAL FINDINGS: The conference developed the research agenda focused on (1) monitoring the health of children; (2) evaluating the efficacy and effectiveness of health services for children; (3) assessing the quality of healthcare provided to children; (4) improving the quality of healthcare within health systems; (5) assessing the performance of community systems for children; (6) exploring the impact of different financial incentives on the provision of pediatric healthcare; and (7) developing and disseminating clinical practice guidelines and other information to physicians, families, and consumers. Specific issues and research questions in each area are also presented. Strategies for implementing the research agenda are presented and include: (1) expanding the child health services research workforce; (2) developing child healthcare quality improvement research centers; (3) conducting research in specific high-priority areas; (4) focusing research on improving the health of vulnerable populations; (5) improving child health data and collection systems at the national level; (6) developing better community health monitoring for children; (7) building and supporting research networks and a consortium of research users; and (8) developing a coordinated interagency federal effort to advance this agenda and to provide accountability for its completion. CONCLUSION: The proposed research agenda should be a national priority so that all Americans can be assured that children are receiving the best quality of care that the United States can provide. PMID:9776945

[Hygienic optimization of the use of chemical protective means on railway transport].

PubMed

Kaptsov, V A; Pankova, V B; Elizarov, B B; Mezentsev, A P; Komleva, E A

2004-01-01

The paper presents data characterizing the working conditions of railway workers. It shows that there is the greatest levels of noise and vibration, the burden and intensity of work. The worst working conditions are noted in energy supply, car, locomotive services and track facilities. The working conditions determine a significant industrial risk of railway workers since the prevention of health abnormalities by using chemical protective means is a topical problem. The priority lines of hygienic rationale for optimization the choice and use of chemical protective means for workers exposed to occupational hazards are determined.

Identifying research priorities with nurses at a tertiary children's hospital in the United Kingdom.

PubMed

Williams, A; Sell, D; Oulton, K; Wilson, N; Wray, J; Gibson, F

2017-03-01

The objective of this study was to undertake a research priority setting exercise with the aim of maximizing efficiency and impact in research activity undertaken by nurses at one children's tertiary healthcare institution by ensuring the clinical staff directly shaped a coherent, transparent and consensus driven nurse-led research agenda. In Round 1, the research topics of 147 nurses were elicited using a modified nominal group technique as the consensus method. The number of participants in the 24 separate discussions ranged from 3 to 21, generating lists of between 6 and 23 topics. In Round 2, nurses from the clinical areas ranked topics of importance resulting in a set of four to five priorities. In Round 3, the divisional heads of nursing consulted with staff in all of their clinical areas to each finalize their five divisional priorities. The Nursing Research Working Group discussed and refined the divisions' priorities and voted on the final list to agree the top five research priorities for the organization. A total of 269 research topics were initially generated. Following three rounds of ranking and prioritizing, five priorities were agreed at Divisional level, and from these, the five top organizational priorities were selected. These were (i) understanding and improving all aspects of the patient journey through the hospital system; (ii) play; (iii) staff wellbeing, patient care and productivity; (iv) team work - linking to a more efficient service; and (v) supporting parents/parent pathway. Divisional priorities have been disseminated widely to clinical teams to inform a patient-specific nurse-led research agenda. Organizational priorities agreed upon have been disseminated through management structures and processes to ensure engagement at all levels. A subgroup of the Nursing Research Working Group has been delegated to take this work forward so that the agreed priorities continue to contribute towards shaping nurse-led research activity, thereby going some way to inform and embed an evidence-based culture of inquiry. © 2016 John Wiley & Sons Ltd.

The VEPSY UPDATED Project: clinical rationale and technical approach.

PubMed

Riva, G; Alcãniz, M; Anolli, L; Bacchetta, M; Baños, R; Buselli, C; Beltrame, F; Botella, C; Castelnuovo, G; Cesa, G; Conti, S; Galimberti, C; Gamberini, L; Gaggioli, A; Klinger, E; Legeron, P; Mantovani, F; Mantovani, G; Molinari, E; Optale, G; Ricciardiello, L; Perpiñá, C; Roy, S; Spagnolli, A; Troiani, R; Weddle, C

2003-08-01

More than 10 years ago, Tart (1990) described virtual reality (VR) as a technological model of consciousness offering intriguing possibilities for developing diagnostic, inductive, psychotherapeutic, and training techniques that can extend and supplement current ones. To exploit and understand this potential is the overall goal of the "Telemedicine and Portable Virtual Environment in Clinical Psychology"--VEPSY UPDATED--a European Community-funded research project (IST-2000-25323, www.cybertherapy.info). Particularly, its specific goal is the development of different PC-based virtual reality modules to be used in clinical assessment and treatment of social phobia, panic disorders, male sexual disorders, obesity, and eating disorders. The paper describes the clinical and technical rationale behind the clinical applications developed by the project. Moreover, the paper focuses its analysis on the possible role of VR in clinical psychology and how it can be used for therapeutic change.

Drug safety assurance through clinical genotyping: near-term considerations for a system-wide implementation of personalized medicine.

PubMed

Kane, Michael D; Springer, John A; Sprague, Jon E

2008-07-01

The rationale and overall system-wide behavior of a clinical genotyping information system (both DNA analysis and data management) requires a near-term, scalable approach, which is emerging in the focused implementation of pharmacogenomics and drug safety assurance. The challenges to implementing a successful clinical genotyping system are described, as are how the benefits of a focused, near-term system for drug safety assessment and assurance overcome the logistical and operational challenges that perpetually hinder the development of a societal-scale clinical genotyping system. This rationale is based on the premise that a focused application domain for clinical genotyping, specifically drug safety assurance, provides a transition paradigm for both professionals and consumers of healthcare, thereby facilitating the movement of genotyping from bench to bedside and paving the way for the adoption of prognostic and diagnostic applications in clinical genomics.

‘Trial Exegesis’: Methods for Synthesizing Clinical and Patient Reported Outcome (PRO) Data in Trials to Inform Clinical Practice. A Systematic Review

PubMed Central

Macefield, Rhiannon C.; Blencowe, Natalie S.; Brookes, Sara T.; Blazeby, Jane M.

2016-01-01

Purpose The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the ‘take home’ message for clinicians to use in practice. Materials and Methods The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice. Results From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a “detailed”, “general”, or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported “detailed” PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving “detailed” rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2). Conclusion It is recommended that single papers, with detailed PRO rationale and integrated PRO and clinical data are published to optimize trial exegesis. Further work to examine whether this improves the use of PRO data to inform practice is needed. PMID:27571514

Importance of neutralization sieve analyses when seeking correlates of HIV-1 vaccine efficacy.

PubMed

Montefiori, David C

2014-01-01

This commentary describes a rationale for the use of breakthrough viruses from clinical trial participants to assess neutralizing antibodies as a correlate of HIV-1 vaccine efficacy. The rationale is based on principles of a genetic sieve analysis, where the 2 analyses may be cooperative for delineating neutralizing antibodies as a mechanistic correlate of protection.

Designing a mixed methods study in primary care.

PubMed

Creswell, John W; Fetters, Michael D; Ivankova, Nataliya V

2004-01-01

Mixed methods or multimethod research holds potential for rigorous, methodologically sound investigations in primary care. The objective of this study was to use criteria from the literature to evaluate 5 mixed methods studies in primary care and to advance 3 models useful for designing such investigations. We first identified criteria from the social and behavioral sciences to analyze mixed methods studies in primary care research. We then used the criteria to evaluate 5 mixed methods investigations published in primary care research journals. Of the 5 studies analyzed, 3 included a rationale for mixing based on the need to develop a quantitative instrument from qualitative data or to converge information to best understand the research topic. Quantitative data collection involved structured interviews, observational checklists, and chart audits that were analyzed using descriptive and inferential statistical procedures. Qualitative data consisted of semistructured interviews and field observations that were analyzed using coding to develop themes and categories. The studies showed diverse forms of priority: equal priority, qualitative priority, and quantitative priority. Data collection involved quantitative and qualitative data gathered both concurrently and sequentially. The integration of the quantitative and qualitative data in these studies occurred between data analysis from one phase and data collection from a subsequent phase, while analyzing the data, and when reporting the results. We recommend instrument-building, triangulation, and data transformation models for mixed methods designs as useful frameworks to add rigor to investigations in primary care. We also discuss the limitations of our study and the need for future research.

Rationale for the Diabetic Retinopathy Clinical Research Network Treatment Protocol for Center-involved Diabetic Macular Edema

PubMed Central

Aiello, Lloyd Paul; Beck, Roy W; Bressler, Neil M.; Browning, David J.; Chalam, KV; Davis, Matthew; Ferris, Frederick L; Glassman, Adam; Maturi, Raj; Stockdale, Cynthia R.; Topping, Trexler

2011-01-01

Objective Describe the underlying principles used to develop a web-based algorithm that incorporated intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in a Diabetic Retinopathy Clinical Research Network (DRCR.net) randomized clinical trial. Design Discussion of treatment protocol for DME. Participants Subjects with vision loss from DME involving the center of the macula. Methods The DRCR.net created an algorithm incorporating anti-VEGF injections in a comparative effectiveness randomized clinical trial evaluating intravitreal ranibizumab with prompt or deferred (≥24 weeks) focal/grid laser in eyes with vision loss from center-involved DME. Results confirmed that intravitreal ranibizumab with prompt or deferred laser provides superior visual acuity outcomes, compared with prompt laser alone through at least 2 years. Duplication of this algorithm may not be practical for clinical practice. In order to share their opinion on how ophthalmologists might emulate the study protocol, participating DRCR.net investigators developed guidelines based on the algorithm's underlying rationale. Main Outcome Measures Clinical guidelines based on a DRCR.net protocol. Results The treatment protocol required real time feedback from a web-based data entry system for intravitreal injections, focal/grid laser, and follow-up intervals. Guidance from this system indicated whether treatment was required or given at investigator discretion and when follow-up should be scheduled. Clinical treatment guidelines, based on the underlying clinical rationale of the DRCR.net protocol, include repeating treatment monthly as long as there is improvement in edema compared with the previous month, or until the retina is no longer thickened. If thickening recurs or worsens after discontinuing treatment, treatment is resumed. Conclusions Duplication of the approach used in the DRCR.net randomized clinical trial to treat DME involving the center of the macula with intravitreal ranibizumab may not be practical in clinical practice, but likely can be emulated based on an understanding of the underlying rationale for the study protocol. Inherent differences between a web-based treatment algorithm and a clinical approach may lead to differences in outcomes that are impossible to predict. The closer the clinical approach is to the algorithm used in the study, the more likely the outcomes will be similar to those published. PMID:22136692

Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema.

PubMed

Aiello, Lloyd Paul; Beck, Roy W; Bressler, Neil M; Browning, David J; Chalam, K V; Davis, Matthew; Ferris, Frederick L; Glassman, Adam R; Maturi, Raj K; Stockdale, Cynthia R; Topping, Trexler M

2011-12-01

To describe the underlying principles used to develop a web-based algorithm that incorporated intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in a Diabetic Retinopathy Clinical Research Network (DRCR.net) randomized clinical trial. Discussion of treatment protocol for DME. Subjects with vision loss resulting from DME involving the center of the macula. The DRCR.net created an algorithm incorporating anti-VEGF injections in a comparative effectiveness randomized clinical trial evaluating intravitreal ranibizumab with prompt or deferred (≥24 weeks) focal/grid laser treatment in eyes with vision loss resulting from center-involved DME. Results confirmed that intravitreal ranibizumab with prompt or deferred laser provides superior visual acuity outcomes compared with prompt laser alone through at least 2 years. Duplication of this algorithm may not be practical for clinical practice. To share their opinion on how ophthalmologists might emulate the study protocol, participating DRCR.net investigators developed guidelines based on the algorithm's underlying rationale. Clinical guidelines based on a DRCR.net protocol. The treatment protocol required real-time feedback from a web-based data entry system for intravitreal injections, focal/grid laser treatment, and follow-up intervals. Guidance from this system indicated whether treatment was required or given at investigator discretion and when follow-up should be scheduled. Clinical treatment guidelines, based on the underlying clinical rationale of the DRCR.net protocol, include repeating treatment monthly as long as there is improvement in edema compared with the previous month or until the retina is no longer thickened. If thickening recurs or worsens after discontinuing treatment, treatment is resumed. Duplication of the approach used in the DRCR.net randomized clinical trial to treat DME involving the center of the macula with intravitreal ranibizumab may not be practical in clinical practice, but likely can be emulated based on an understanding of the underlying rationale for the study protocol. Inherent differences between a web-based treatment algorithm and a clinical approach may lead to differences in outcomes that are impossible to predict. The closer the clinical approach is to the algorithm used in the study, the more likely the outcomes will be similar to those published. Proprietary or commercial disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

A consensus exercise identifying priorities for research into clinical effectiveness among children's orthopaedic surgeons in the United Kingdom.

PubMed

Perry, D C; Wright, J G; Cooke, S; Roposch, A; Gaston, M S; Nicolaou, N; Theologis, T

2018-05-01

Aims High-quality clinical research in children's orthopaedic surgery has lagged behind other surgical subspecialties. This study used a consensus-based approach to identify research priorities for clinical trials in children's orthopaedics. Methods A modified Delphi technique was used, which involved an initial scoping survey, a two-round Delphi process and an expert panel formed of members of the British Society of Children's Orthopaedic Surgery. The survey was conducted amongst orthopaedic surgeons treating children in the United Kingdom and Ireland. Results A total of 86 clinicians contributed to both rounds of the Delphi process, scoring priorities from one (low priority) to five (high priority). Elective topics were ranked higher than those relating to trauma, with the top ten elective research questions scoring higher than the top question for trauma. Ten elective, and five trauma research priorities were identified, with the three highest ranked questions relating to the treatment of slipped capital femoral epiphysis (mean score 4.6/ 5), Perthes' disease (4.5) and bone infection (4.5). Conclusion This consensus-based research agenda will guide surgeons, academics and funders to improve the evidence in children's orthopaedic surgery and encourage the development of multicentre clinical trials. Cite this article: Bone Joint J 2018;100-B:680-4.

Clinical Research Priorities in Adult Congenital Heart Disease

PubMed Central

Cotts, Timothy; Khairy, Paul; Opotowsky, Alexander R.; John, Anitha S.; Valente, Anne Marie; Zaidi, Ali N.; Cook, Stephen C.; Aboulhosn, Jamil; Ting, Jennifer Grando; Gurvitz, Michelle; Landzberg, Michael J.; Verstappen, Amy; Kay, Joseph; Earing, Michael; Franklin, Wayne; Kogon, Brian; Broberg, Craig S.

2014-01-01

Background Adult congenital heart disease (ACHD) clinicians are hampered by the paucity of data to inform clinical decision-making. The objective of this study was to identify priorities for clinical research in ACHD. Methods A list of 45 research questions was developed by the Alliance for Adult Research in Congenital Cardiology (AARCC), compiled into a survey, and administered to ACHD providers. Patient input was sought via the Adult Congenital Heart Association at community meetings and online forums. The 25 top questions were sent to ACHD providers worldwide via an online survey. Each question was ranked based on perceived priority and weighted based on time spent in ACHD care. The top 10 topics identified are presented and discussed. Results The final online survey yielded 139 responses. Top priority questions related to tetralogy of Fallot (timing of pulmonary valve replacement and criteria for primary prevention ICDs), patients with systemic right ventricles (determining the optimal echocardiographic techniques for measuring right ventricular function, and indications for tricuspid valve replacement and primary prevention ICDs), and single ventricle/Fontan patients (role of pulmonary vasodilators, optimal anticoagulation, medical therapy for preservation of ventricular function, treatment for protein losing enteropathy). In addition, establishing criteria to refer ACHD patients for cardiac transplantation was deemed a priority. Conclusions The ACHD field is in need of prospective research to address fundamental clinical questions. It is hoped that this methodical consultation process will inform researchers and funding organizations about clinical research topics deemed to be of high priority. PMID:24411207

Clinical research priorities in adult congenital heart disease.

PubMed

Cotts, Timothy; Khairy, Paul; Opotowsky, Alexander R; John, Anitha S; Valente, Anne Marie; Zaidi, Ali N; Cook, Stephen C; Aboulhosn, Jamil; Ting, Jennifer Grando; Gurvitz, Michelle; Landzberg, Michael J; Verstappen, Amy; Kay, Joseph; Earing, Michael; Franklin, Wayne; Kogon, Brian; Broberg, Craig S

2014-02-15

Adult congenital heart disease (ACHD) clinicians are hampered by the paucity of data to inform clinical decision-making. The objective of this study was to identify priorities for clinical research in ACHD. A list of 45 research questions was developed by the Alliance for Adult Research in Congenital Cardiology (AARCC), compiled into a survey, and administered to ACHD providers. Patient input was sought via the Adult Congenital Heart Association at community meetings and online forums. The 25 top questions were sent to ACHD providers worldwide via an online survey. Each question was ranked based on perceived priority and weighted based on time spent in ACHD care. The top 10 topics identified are presented and discussed. The final online survey yielded 139 responses. Top priority questions related to tetralogy of Fallot (timing of pulmonary valve replacement and criteria for primary prevention ICDs), patients with systemic right ventricles (determining the optimal echocardiographic techniques for measuring right ventricular function, and indications for tricuspid valve replacement and primary prevention ICDs), and single ventricle/Fontan patients (role of pulmonary vasodilators, optimal anticoagulation, medical therapy for preservation of ventricular function, treatment for protein losing enteropathy). In addition, establishing criteria to refer ACHD patients for cardiac transplantation was deemed a priority. The ACHD field is in need of prospective research to address fundamental clinical questions. It is hoped that this methodical consultation process will inform researchers and funding organizations about clinical research topics deemed to be of high priority. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Development of research priorities in paediatric pain and palliative care

PubMed Central

Liossi, Christina; Anderson, Anna-Karenia; Howard, Richard F

2016-01-01

Priority setting for healthcare research is as important as conducting the research itself because rigorous and systematic processes of priority setting can make an important contribution to the quality of research. This project aimed to prioritise clinical therapeutic uncertainties in paediatric pain and palliative care in order to encourage and inform the future research agenda and raise the profile of paediatric pain and palliative care in the United Kingdom. Clinical therapeutic uncertainties were identified and transformed into patient, intervention, comparison and outcome (PICO) format and prioritised using a modified Nominal Group Technique. Members of the Clinical Studies Group in Pain and Palliative Care within National Institute for Health Research (NIHR) Clinical Research Network (CRN)-Children took part in the prioritisation exercise. There were 11 clinically active professionals spanning across a wide range of paediatric disciplines and one parent representative. The top three research priorities related to establishing the safety and efficacy of (1) gabapentin in the management of chronic pain with neuropathic characteristics, (2) intravenous non-steroidal anti-inflammatory drugs in the management of post-operative pain in pre-schoolers and (3) different opioid formulations in the management of acute pain in children while at home. Questions about the long-term effect of psychological interventions in the management of chronic pain and various pharmacological interventions to improve pain and symptom management in palliative care were among the ‘top 10’ priorities. The results of prioritisation were included in the UK Database of Uncertainties about the Effects of Treatments (DUETS) database. Increased awareness of priorities and priority-setting processes should encourage clinicians and other stakeholders to engage in such exercises in the future. PMID:28386399

Mixed-methods designs in mental health services research: a review.

PubMed

Palinkas, Lawrence A; Horwitz, Sarah M; Chamberlain, Patricia; Hurlburt, Michael S; Landsverk, John

2011-03-01

Despite increased calls for use of mixed-methods designs in mental health services research, how and why such methods are being used and whether there are any consistent patterns that might indicate a consensus about how such methods can and should be used are unclear. Use of mixed methods was examined in 50 peer-reviewed journal articles found by searching PubMed Central and 60 National Institutes of Health (NIH)-funded projects found by searching the CRISP database over five years (2005-2009). Studies were coded for aims and the rationale, structure, function, and process for using mixed methods. A notable increase was observed in articles published and grants funded over the study period. However, most did not provide an explicit rationale for using mixed methods, and 74% gave priority to use of quantitative methods. Mixed methods were used to accomplish five distinct types of study aims (assess needs for services, examine existing services, develop new or adapt existing services, evaluate services in randomized controlled trials, and examine service implementation), with three categories of rationale, seven structural arrangements based on timing and weighting of methods, five functions of mixed methods, and three ways of linking quantitative and qualitative data. Each study aim was associated with a specific pattern of use of mixed methods, and four common patterns were identified. These studies offer guidance for continued progress in integrating qualitative and quantitative methods in mental health services research consistent with efforts by NIH and other funding agencies to promote their use.

Creating a Research Agenda and Setting Research Priorities for Clinical Nurse Specialists.

PubMed

Foster, Jan; Bautista, Cynthia; Ellstrom, Kathleen; Kalowes, Peggy; Manning, Jennifer; Pasek, Tracy Ann

The purpose of this article is to describe the evolution and results of the process for establishing a research agenda and identification of research priorities for clinical nurse specialists, approved by the National Association of Clinical Nurse Specialists (NACNS) membership and sanctioned by the NACNS Board of Directors. Development of the research agenda and identification of the priorities were an iterative process and involved a review of the literature; input from multiple stakeholders, including individuals with expertise in conducting research serving as task force members, and NACNS members; and feedback from national board members. A research agenda, which is to provide an enduring research platform, was established and research priorities, which are to be applied in the immediate future, were identified as a result of this process. Development of a research agenda and identification of research priorities are a key method of fulfilling the mission and goals of NACNS. The process and outcomes are described in this article.

Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

PubMed

Revicki, Dennis A; Gnanasakthy, Ari; Weinfurt, Kevin

2007-05-01

The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

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

PubMed

Morgano, Gian Paolo; Parmelli, Elena; Amato, Laura; Iannone, Primiano; Marchetti, Marco; Moja, Lorenzo; Davoli, Marina; Schünemann, Holger

2018-05-01

In the first article in this series we described the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision (EtD) frameworks and their rationale for different types of decisions. In this second article, we describe the use of EtD frameworks for clinical recommendations and how it can help clinicians and patients who use those recommendations. EtD frameworks for clinical practice recommendations provide a structured and transparent approach for guideline panels. The framework helps ensure consideration of key criteria that determine whether an intervention should be recommended and that judgments are informed by the best available evidence. Frameworks are also a way for panels to make guideline users aware of the rationale (justification) for their recommendations.

Rational and irrational clinical strategies for collaborative medicine.

PubMed

Hammerly, Milt

2002-01-01

Individual practitioners and health care systems/organizations increasingly understand the rationale for collaborative medicine. An absence of collaboration can compromise the quality and safety of patient care. But having a rationale to provide collaborative medicine without also having a rational clinical strategy can be equally compromising to the quality and safety of patient care. Reasonable evidentiary criteria must be used to determine whether specific therapies merit inclusion or exclusion in a collaborative medicine model. Ranking therapies hierarchically on the basis of their risk-benefit ratio simplifies matching of therapies with the needs of the patient. A unifying taxonomy that categorizes all therapies (complementary/alternative and conventional) on the basis of how we think they work (presumed mechanisms of action) facilitates development of a clinical strategy for collaborative medicine. On the basis of these principles, a rational clinical strategy for collaborative medicine is described to help optimize the quality and safety of patient care.

NITRIC OXIDE FOR THE ADJUNCTIVE TREATMENT OF SEVERE MALARIA: HYPOTHESIS AND RATIONALE

PubMed Central

Hawkes, Michael; Opoka, Robert Opika; Namasopo, Sophie; Miller, Christopher; Conroy, Andrea L.; Serghides, Lena; Kim, Hani; Thampi, Nisha; Liles, W. Conrad; John, Chandy C.; Kain, Kevin C.

2011-01-01

We hypothesize that supplemental inhaled nitric oxide (iNO) will improve outcomes in children with severe malaria receiving standard antimalarial therapy. The rationale for the hypothesized efficacy of iNO rests on: (1) biological plausibility, based on known actions of NO in modulating endothelial activation; (2) pre-clinical efficacy data from animal models of experimental cerebral malaria; and (3) a human trial of the NO precursor L-arginine, which improved endothelial function in adults with severe malaria. iNO is an attractive new candidate for the adjunctive treatment of severe malaria, given its proven therapeutic efficacy in animal studies, track record of safety in clinical practice and numerous clinical trials, inexpensive manufacturing costs, and ease of administration in settings with limited healthcare infrastructure. We plan to test this hypothesis in a randomized controlled trial (ClinicalTrials.gov Identifier: NCT01255215). PMID:21745716

The rationale for Janus kinase inhibitors for the treatment of spondyloarthritis.

PubMed

Veale, Douglas J; McGonagle, Dennis; McInnes, Iain B; Krueger, James G; Ritchlin, Christopher T; Elewaut, Dirk; Kanik, Keith S; Hendrikx, Thijs; Berstein, Gabriel; Hodge, Jennifer; Telliez, Jean-Baptiste

2018-04-03

The pathogenesis of SpA is multifactorial and involves a range of immune cell types and cytokines, many of which utilize Janus kinase (JAK) pathways for signaling. In this review, we summarize the animal and pre-clinical data that have demonstrated the effects of JAK blockade on the underlying molecular mechanisms of SpA and provide a rationale for JAK inhibition for the treatment of SpA. We also review the available clinical trial data evaluating JAK inhibitors tofacitinib, baricitinib, peficitinib, filgotinib and upadacitinib in PsA, AS and related inflammatory diseases, which have demonstrated the efficacy of these agents across a range of SpA-associated disease manifestations. The available clinical trial data, supported by pre-clinical animal model studies demonstrate that JAK inhibition is a promising therapeutic strategy for the treatment of SpA and may offer the potential for improvements in multiple articular and extra-articular disease manifestations of PsA and AS.

Designing A Mixed Methods Study In Primary Care

PubMed Central

Creswell, John W.; Fetters, Michael D.; Ivankova, Nataliya V.

2004-01-01

BACKGROUND Mixed methods or multimethod research holds potential for rigorous, methodologically sound investigations in primary care. The objective of this study was to use criteria from the literature to evaluate 5 mixed methods studies in primary care and to advance 3 models useful for designing such investigations. METHODS We first identified criteria from the social and behavioral sciences to analyze mixed methods studies in primary care research. We then used the criteria to evaluate 5 mixed methods investigations published in primary care research journals. RESULTS Of the 5 studies analyzed, 3 included a rationale for mixing based on the need to develop a quantitative instrument from qualitative data or to converge information to best understand the research topic. Quantitative data collection involved structured interviews, observational checklists, and chart audits that were analyzed using descriptive and inferential statistical procedures. Qualitative data consisted of semistructured interviews and field observations that were analyzed using coding to develop themes and categories. The studies showed diverse forms of priority: equal priority, qualitative priority, and quantitative priority. Data collection involved quantitative and qualitative data gathered both concurrently and sequentially. The integration of the quantitative and qualitative data in these studies occurred between data analysis from one phase and data collection from a subsequent phase, while analyzing the data, and when reporting the results. DISCUSSION We recommend instrument-building, triangulation, and data transformation models for mixed methods designs as useful frameworks to add rigor to investigations in primary care. We also discuss the limitations of our study and the need for future research. PMID:15053277

Priority setting in the Austrian healthcare system: results from a discrete choice experiment and implications for mental health.

PubMed

Mentzakis, Emmanouil; Paolucci, Francesco; Rubicko, Georg

2014-06-01

The impact of mental conditions is expected to be among the highest ranked causes of illness in high income countries by 2020. With changing health needs, policy makers have to make choices in an environment with increasingly constrained resources and competing demands. Discrete choice experiments have been identified as a useful approach to inform and support decision-making in health care systems and, in particular, its rationing. Policymakers, researchers and health practitioners from Austria participated in an experiment designed to elicit preferences for efficiency and equity in a generic priority setting framework. Using aggregate criteria an empirical measure of the efficiency/equity trade-off is calculated and a selection of health care interventions, including mental health, are ranked in composite league tables (CLTs). With the exception of severity of the condition, all equity parameters decrease attractiveness of an intervention, whereas the opposite holds for all three efficiency criteria. The efficiency/equity ratio (i.e. decision-makers' preference for efficiency over equity) is 3.5 and 5 for interventions targeted at younger and middle age populations, respectively, while for older populations this ratio is negative implying a rejection of all equity criteria. Irrespective of such differences interventions targeting mental health rank highly on all CLTs. Based on system-wide generic decision making criteria, mental health is shown to be a top priority for Austria. Preference-based approaches might offer complementary information to policymakers in priority setting decisions and a useful tool to support rationale rather than ad hoc decision-making.

Delphi Survey of Clinical Nursing and Midwifery Research Priorities in the Eastern Mediterranean Region.

PubMed

Sun, Carolyn; Dohrn, Jennifer; Oweis, Arwa; Huijer, Huda Abu-Saad; Abu-Moghli, Fathieh; Dawani, Hania; Ghazi, Cheherezade; Larson, Elaine

2017-03-01

As the shortage of nurses and midwives is expected to worsen in the Eastern Mediterranean region concomitantly with a growing focus on achievement of universal health coverage, nurses and midwives are expected to fill major gaps in health care. Hence, the need for a solid evidence base for nursing practice and a clear direction for clinical nursing research are paramount. Therefore, a Delphi survey was conducted to determine clinical (research focused on patient outcomes) nursing and midwifery priorities for research within this region. A Delphi survey, using iterative rounds of an online survey of regional clinical nursing and midwifery research experts, was conducted between January and April 2016. Consensus was determined by percentage agreement on level of priority for topics as determined by participants. Additionally, results were compared between countries within the region by income and mortality levels using Kendall's tau. Critical research topics were focused on public/community/primary care as well as emergency preparedness for disasters, and these priorities are well aligned with gaps in the literature for this region. There were statistically significant differences between priority level and country mortality group for geriatrics, self-management of disease, and sexually transmitted infections. Critical research priorities should focus on population-based health topics. Between-country differences should be analyzed further. A clinical research database for the region may help improve research access for nurses and midwives. Practicing nurses and midwives lack extensive evidence (including culturally relevant evidence) on which to practice. Increasing research in areas identified in this survey may improve patient outcomes and quality of care regionally. © 2017 Sigma Theta Tau International.

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

PROFESSIONAL INTEGRATION AND CLINICAL RESEARCH.

ERIC Educational Resources Information Center

WARD, TED W.

THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…

Increasing access by priority populations to Australian sexual health clinics.

PubMed

Ali, Hammad; Donovan, Basil; Fairley, Christopher K; Chen, Marcus Y; O'Connor, Catherine C; Grulich, Andrew E; McNulty, Anna; Ryder, Nathan; Hellard, Margaret E; Guy, Rebecca J

2013-10-01

Data from a network of 35 Australian sexual health clinics, in geographically diverse locations, showed that the number and proportion of patients from priority populations (ie, young people, men who have sex with men, indigenous people, and female sex workers) increased significantly between 2004 and 2011.

Paradox of Prescribing Late Chemotherapy: Oncologists Explain.

PubMed

Bluhm, Minnie; Connell, Cathleen M; De Vries, Raymond G; Janz, Nancy K; Bickel, Kathleen E; Silveira, Maria J

2016-12-01

The value of chemotherapy for patients with cancer in the last weeks of life warrants examination. Late chemotherapy may not improve survival or quality of life but typically precludes hospice enrollment and may result in additional symptoms, increased use of other aggressive treatments, and worsening quality of life. Few studies have explored oncologists' rationales for administering chemotherapy near death. This study examines the self-reported factors that influence oncologists' decisions about late chemotherapy. In-depth individual interviews were conducted with 17 oncologists through a semistructured interview guide. Interviews were audio recorded and transcribed verbatim. Transcripts were coded and analyzed using conventional content analysis, a qualitative method that allows the detection and analysis of patterns in the data. Clinical factors take priority in determining late chemotherapy decisions when clear treatment choices exist. When clinical factors are ambiguous, emotion becomes a highly salient influence. Oncologists view late chemotherapy to be patient driven and use it to palliate emotional distress and maintain patient hope even when physical benefit is unexpected. Oncologists experience unique and difficult challenges when caring for dying patients, including emotionally draining communication, overwhelming responsibility for life/death, limitations of oncology to heal, and prognostic uncertainty. These challenges are also eased by offering late chemotherapy. The findings reveal a nuanced understanding of why oncologists find it difficult to refuse chemotherapy treatment for patients near death. Optimal end-of-life treatment decisions require supportive interventions and system change, both of which must take into account the challenges oncologists face.

Public health benefits of strategies to reduce greenhouse-gas emissions: overview and implications for policy makers.

PubMed

Haines, Andy; McMichael, Anthony J; Smith, Kirk R; Roberts, Ian; Woodcock, James; Markandya, Anil; Armstrong, Ben G; Campbell-Lendrum, Diarmid; Dangour, Alan D; Davies, Michael; Bruce, Nigel; Tonne, Cathryn; Barrett, Mark; Wilkinson, Paul

2009-12-19

This Series has examined the health implications of policies aimed at tackling climate change. Assessments of mitigation strategies in four domains-household energy, transport, food and agriculture, and electricity generation-suggest an important message: that actions to reduce greenhouse-gas emissions often, although not always, entail net benefits for health. In some cases, the potential benefits seem to be substantial. This evidence provides an additional and immediate rationale for reductions in greenhouse-gas emissions beyond that of climate change mitigation alone. Climate change is an increasing and evolving threat to the health of populations worldwide. At the same time, major public health burdens remain in many regions. Climate change therefore adds further urgency to the task of addressing international health priorities, such as the UN Millennium Development Goals. Recognition that mitigation strategies can have substantial benefits for both health and climate protection offers the possibility of policy choices that are potentially both more cost effective and socially attractive than are those that address these priorities independently. Copyright 2009 Elsevier Ltd. All rights reserved.

Engaging with Comparative Risk Appraisals: Public Views on Policy Priorities for Environmental Risk Governance.

PubMed

Rocks, Sophie A; Schubert, Iljana; Soane, Emma; Black, Edgar; Muckle, Rachel; Petts, Judith; Prpich, George; Pollard, Simon J

2017-09-01

Communicating the rationale for allocating resources to manage policy priorities and their risks is challenging. Here, we demonstrate that environmental risks have diverse attributes and locales in their effects that may drive disproportionate responses among citizens. When 2,065 survey participants deployed summary information and their own understanding to assess 12 policy-level environmental risks singularly, their assessment differed from a prior expert assessment. However, participants provided rankings similar to those of experts when these same 12 risks were considered as a group, allowing comparison between the different risks. Following this, when individuals were shown the prior expert assessment of this portfolio, they expressed a moderate level of confidence with the combined expert analysis. These are important findings for the comprehension of policy risks that may be subject to augmentation by climate change, their representation alongside other threats within national risk assessments, and interpretations of agency for public risk management by citizens and others. © 2017 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

Discovering the Regulatory Considerations of the Federal Aviation Administration: Interviewing the Aviation Rulemaking Advisory Committee

NASA Technical Reports Server (NTRS)

Lu, Chien-tsung

2005-01-01

Maintenance Resource Management (MRM) training for aviation mechanics has become mandatory in many industrialized countries since 1998. Yet, to date, MRM training remains optional in the U.S. Interestingly, a similar safety discipline, namely Crew/Cockpit Resource Management (CRM), is mandatory for pilots, flight engineers, flight attendants, and dispatchers and is regulated in the Federal Aviation Administration s (FAA) Federal Aviation Regulations (FARs). If MRM training is important to enhance aviation technicians working behavior, the rationale to not regulate it opens a window for study. This research aims to inductively investigate the FAA s regulatory rationale concerning MRM training based on direct inputs from the FAA s Aviation Rulemaking Advisory Committee (ARAC) members. Delphi methodology associated with purposive sampling technique was adopted. The result revealed that the FAA cannot regulate MRM because the aviation industry is strongly opposed to it due to the lack of training budgets, the need of a quantifiable cost-effect analysis, concern over the FAA s inspection workforce, an ongoing voluntary alternative called the Air Transportation Surveillance System (ATOS), the government s lower priority on maintenance after 9/11, and the airlines tight embracement of operational flexibility without regulation.

[Hydrotherapy equipment].

PubMed

Tsibikov, V B; Ragozin, S I; Mikheeva, L V

1985-01-01

A flow-chart is developed demonstrating the relation between medical and prophylactic institutions within the organizational structure of the rehabilitation system and main types of rehabilitation procedures. In order to ascertain the priority in equipping rehabilitation services with adequate hardware the special priority criterion is introduced. The highest priority is assigned to balneotherapeutic and fangotherapeutic services. Based on the operation-by-operation analysis of clinical processes related to service and performance of balneologic procedures the preliminary set of clinical devices designed for baths, basins and showers in hospitals and rehabilitation departments is defined in a generalized form.

What Should We Teach the Teachers? Identifying the Learning Priorities of Clinical Supervisors

ERIC Educational Resources Information Center

Bearman, Margaret; Tai, Joanna; Kent, Fiona; Edouard, Vicki; Nestel, Debra; Molloy, Elizabeth

2018-01-01

Clinicians who teach are essential for the health workforce but require faculty development to improve their educational skills. Curricula for faculty development programs are often based on expert frameworks without consideration of the learning priorities as defined by clinical supervisors themselves. We sought to inform these curricula by…

Rationale for combination of therapeutic antibodies targeting tumor cells and immune checkpoint receptors: Harnessing innate and adaptive immunity through IgG1 isotype immune effector stimulation.

PubMed

Ferris, Robert L; Lenz, Heinz-Josef; Trotta, Anna Maria; García-Foncillas, Jesús; Schulten, Jeltje; Audhuy, François; Merlano, Marco; Milano, Gerard

2018-02-01

Immunoglobulin (Ig) G1 antibodies stimulate antibody-dependent cell-mediated cytotoxicity (ADCC). Cetuximab, an IgG1 isotype monoclonal antibody, is a standard-of-care treatment for locally advanced and recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) and metastatic colorectal cancer (CRC). Here we review evidence regarding the clinical relevance of cetuximab-mediated ADCC and other immune functions and provide a biological rationale concerning why this property positions cetuximab as an ideal partner for immune checkpoint inhibitors (ICIs) and other emerging immunotherapies. We performed a nonsystematic review of available preclinical and clinical data involving cetuximab-mediated immune activity and combination approaches of cetuximab with other immunotherapies, including ICIs, in SCCHN and CRC. Indeed, cetuximab mediates ADCC activity in the intratumoral space and primes adaptive and innate cellular immunity. However, counterregulatory mechanisms may lead to immunosuppressive feedback loops. Accordingly, there is a strong rationale for combining ICIs with cetuximab for the treatment of advanced tumors, as targeting CTLA-4, PD-1, and PD-L1 can ostensibly overcome these immunosuppressive counter-mechanisms in the tumor microenvironment. Moreover, combining ICIs (or other immunotherapies) with cetuximab is a promising strategy for boosting immune response and enhancing response rates and durability of response. Cetuximab immune activity-including, but not limited to, ADCC-provides a strong rationale for its combination with ICIs or other immunotherapies to synergistically and fully mobilize the adaptive and innate immunity against tumor cells. Ongoing prospective studies will evaluate the clinical effect of these combination regimens and their immune effect in CRC and SCCHN and in other indications. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Science and Measurement Requirements for a Plant Physiology and Functional Types Mission: Measuring the Composition, Function and Health of Global Land and Coastal Ocean Ecosystems

NASA Technical Reports Server (NTRS)

Green, Robert O.; Rogez, Francois; Green, Rob; Ungar, Steve; Knox, Robert; Asner, Greg; Muller-Karger, Frank; Bissett, Paul; Chekalyuk, Alex; Dierssen, Heidi;

Practice of Clinical Supervision.

ERIC Educational Resources Information Center

Holland, Patricia E.

1988-01-01

Clinical supervision remained grounded in empirical inquiry as late as Morris Cogan's writings on the subject in 1973. With the acknowledgment of Thomas Kuhn's (1962) paradigm shift, educational theory and practice developed interpretive methodologies. An interpretive reflection on Cogan's rationale offers insights into the current, matured…

Generating political priority for regulatory interventions targeting obesity prevention: an Australian case study.

PubMed

Baker, Phillip; Gill, Timothy; Friel, Sharon; Carey, Gemma; Kay, Adrian

2017-03-01

Effective obesity prevention requires a synergistic mix of population-level interventions including a strong role for government and the regulation of the marketing, labelling, content and pricing of energy-dense foods and beverages. In this paper we adopt the agenda of the Australian Federal Government (AFG) as a case study to understand the factors generating or hindering political priority for such 'regulatory interventions' between 1990 and 2011. Using a theoretically-guided process tracing method we undertook documentary analysis and conducted 27 interviews with a diversity of actors involved in obesity politics. The analysis was structured by a theoretical framework comprising four dimensions: the power of actors involved; the ideas the actors deploy to interpret and portray the issue; the institutional and political context; and issue characteristics. Despite two periods of sustained political attention, political priority for regulatory interventions did not emerge and was hindered by factors from all four dimensions. Within the public health community, limited cohesion among experts and advocacy groups hampered technical responses and collective action efforts. An initial focus on children (child obesity), framing the determinants of obesity as 'obesogenic environments', and the deployment of 'protecting kids', 'industry demonization' and 'economic costs' frames generated political attention. Institutional norms within government effectively selected out regulatory interventions from consideration. The 'productive power' and activities of the food and advertising industries presented formidable barriers, buttressed by a libertarian/neolibertarian rhetoric emphasizing individual responsibility, a negative view of freedom (as free from 'nanny-state' intervention) and the idea that regulation imposes an unacceptable cost on business. Issue complexity, the absence of a supportive evidence base and a strict 'evidence-based' policy-making approach were used as rationales to defer political priority. Overcoming these challenges may be important to future collective action efforts attempting to generate and sustain political priority for regulatory interventions targeting obesity. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improving care for people with osteoarthritis of the hip and knee: how has national policy for osteoarthritis been translated into service models in Australia?

PubMed

Brand, Caroline; Hunter, David; Hinman, Rana; March, Lyn; Osborne, Richard; Bennell, Kim

2011-05-01

There is strong rationale for improving care for people with chronic conditions, including osteoarthritis (OA). Successful implementation of healthcare reform requires new concepts and directions that are strongly supported by policy, new models of care (service redesign) and changes in day-to-day practice (healthcare provider and patient practice). In this paper we discuss the extent to which policy about management of OA of the hip and knee has been translated into new service models in Australia. A structured search of government and other key health websites in Australia was performed to identify policy, funding initiatives and new services models for managing OA of the hip and knee. This search was supported by a literature review. Musculoskeletal conditions were designated a National Health Priority in Australia in 2002. Under the Better Arthritis and Osteoporosis Care initiative, Australia has developed a national policy for OA care and national evidence-based clinical practice guidelines for management of OA of the hip and knee. Only two well-described examples of new chronic disease management service models, the Osteoarthritis Clinical Pathway (OACP) model and the Osteoarthritis Hip and Knee Service (OAHKS) were identified. Primarily focused within acute care public hospital settings, these have been shown to be feasible and acceptable but have limited data on clinical impact and cost-effectiveness. While policy is extant, implementation has not been systematic and comprehensive. Clinicians have evidence-based recommendations for OA management but are poorly supported by service models to deliver these effectively and efficiently. © 2011 The Authors. International Journal of Rheumatic Diseases © 2011 Asia Pacific League of Associations for Rheumatology and Blackwell Publishing Asia Pty Ltd.

Theoretical Issues in Clinical Social Group Work.

ERIC Educational Resources Information Center

Randall, Elizabeth; Wodarski, John S.

1989-01-01

Reviews relevant issues in clinical social group practice including group versus individual treatment, group work advantages, approach rationale, group conditions for change, worker role in group, group composition, group practice technique and method, time as group work dimension, pretherapy training, group therapy precautions, and group work…

Why attend a memory clinic? What do patients and their families want and/or expect?

PubMed

Mastwyk, Maree; Dow, Briony; Ellis, Kathryn A; Ames, David

2016-09-01

To explore which symptoms led people to seek a memory clinic assessment and what they wanted and expected from that assessment. Did the patient and family want and/or expect diagnostic disclosure and, if so, why? Patients scheduled for memory clinic appoint-ments received two questionnaires by post prior to clinic attendance - one for the patient, one for the next-of- kin - regarding symptomatology, wants, expectations and rationale. Ninety-two per cent of patients (n = 47) and 88% (n = 43) of next-of-kin wanted the patient to be informed of the diagnosis; 84% (n = 43) of patients and 86% (n = 42) of next-of-kin expected the patient to be informed. Rationales for diagnostic disclosure were categorised under themes of planning, treatment, information, coping strategies and rights. Patients and families want diagnostic disclosure in order to plan, receive treatment, receive help and learn strategies to cope. This knowledge is seen as the patient's right. © 2016 AJA Inc.

Few Americans Receive All High-Priority, Appropriate Clinical Preventive Services.

PubMed

Borsky, Amanda; Zhan, Chunliu; Miller, Therese; Ngo-Metzger, Quyen; Bierman, Arlene S; Meyers, David

2018-06-01

As of 2015, only 8 percent of US adults ages thirty-five and older had received all of the high-priority, appropriate clinical preventive services recommended for them. Nearly 5 percent of adults did not receive any such services. Further delivery system-level efforts are needed to increase the use of preventive services.

Mesenchymal stromal cells: a novel therapy for the treatment of chronic obstructive pulmonary disease?

PubMed Central

Broekman, Winifred; Khedoe, Padmini P S J; Schepers, Koen; Roelofs, Helene; Stolk, Jan; Hiemstra, Pieter S

2018-01-01

COPD is characterised by tissue destruction and inflammation. Given the lack of curative treatments and the progressive nature of the disease, new treatments for COPD are highly relevant. In vitro cell culture and animal studies have demonstrated that mesenchymal stromal cells (MSCs) have the capacity to modify immune responses and to enhance tissue repair. These properties of MSCs provided a rationale to investigate their potential for treatment of a variety of diseases, including COPD. Preclinical models support the hypothesis that MSCs may have clinical efficacy in COPD. However, although clinical trials have demonstrated the safety of MSC treatment, thus far they have not provided evidence for MSC efficacy in the treatment of COPD. In this review, we discuss the rationale for MSC-based cell therapy in COPD, the main findings from in vitro and in vivo preclinical COPD model studies, clinical trials in patients with COPD and directions for further research. PMID:29653970

The Role of the Pediatrician in Primary Prevention of Obesity.

PubMed

Daniels, Stephen R; Hassink, Sandra G

2015-07-01

The adoption of healthful lifestyles by individuals and families can result in a reduction in many chronic diseases and conditions of which obesity is the most prevalent. Obesity prevention, in addition to treatment, is an important public health priority. This clinical report describes the rationale for pediatricians to be an integral part of the obesity-prevention effort. In addition, the 2012 Institute of Medicine report "Accelerating Progress in Obesity Prevention" includes health care providers as a crucial component of successful weight control. Research on obesity prevention in the pediatric care setting as well as evidence-informed practical approaches and targets for prevention are reviewed. Pediatricians should use a longitudinal, developmentally appropriate life-course approach to help identify children early on the path to obesity and base prevention efforts on family dynamics and reduction in high-risk dietary and activity behaviors. They should promote a diet free of sugar-sweetened beverages, of fewer foods with high caloric density, and of increased intake of fruits and vegetables. It is also important to promote a lifestyle with reduced sedentary behavior and with 60 minutes of daily moderate to vigorous physical activity. This report also identifies important gaps in evidence that need to be filled by future research. Copyright © 2015 by the American Academy of Pediatrics.

Video gaming and sexual violence: rethinking forensic nursing in a digital age.

PubMed

Mercer, Dave; Parkinson, Denis

2014-01-01

This article reports findings from a qualitative study into how forensic nurses, and male personality disordered sexual offenders, talked about "pornography" in one U.K. high-security hospital. Research rationale was rooted in current professional and political debates, adopting a discourse analytic design to situate the project in a clinical context. Semistructured interviews, as co-constructed accounts, explored talk about sexual media, offending, treatment, and risk. Data were analyzed using a version of discourse analysis popular in healthcare research, identifying discursive repertoires, or collective language use, characteristic of the institutional culture. Findings revealed that masculine discourse marginalized female nurses and contradicted therapeutic goals, where men's talk about pornography, sex, and sexual crime represented discriminatory and gendered language. Nursing definitions of pornography were constructed in the context of the client group and an organizational need to manage risk. In a highly controlled environment, with a long-stay population, priority in respondent talk was given to mainstream commercial sexual media and everyday items/images perceived to have embedded sexual meaning. However, little mention was made of contemporary modes of producing/distributing pornography, where sex and sexual violence are enacted in virtual realities of cyberspace. Failure to engage with information technology, and globally mediated sex, is discussed as a growing concern for forensic health workers.

Measurement of leukocyte rheology in vascular disease: clinical rationale and methodology. International Society of Clinical Hemorheology.

PubMed

Wautier, J L; Schmid-Schönbein, G W; Nash, G B

1999-01-01

The measurement of leukocyte rheology in vascular disease is a recent development with a wide range of new opportunities. The International Society of Clinical Hemorheology has asked an expert panel to propose guidelines for the investigation of leukocyte rheology in clinical situations. This article first discusses the mechanical, adhesive and related functional properties of leukocytes (especially neutrophils) which influence their circulation, and establishes the rationale for clinically-related measurements of parameters which describe them. It is concluded that quantitation of leukocyte adhesion molecules, and of their endothelial receptors may assist understanding of leukocyte behaviour in vascular disease, along with measurements of flow resistance of leukocytes, free radical production, degranulation and gene expression. For instance, vascular cell adhesion molecule (VCAM-1) is abnormally present on endothelial cells in atherosclerosis, diabetes mellitus and inflammatory conditions. Soluble forms of intercellular adhesion molecule (ICAM-1) or VCAM can be found elevated in the blood of patients with rheumatoid arthritis or infections disease. In the second part of the article, possible technical approaches are presented and possible avenues for leukocyte rheological investigations are discussed.

Compact CPE: a full unit of clinical pastoral education in 27 days.

PubMed

Beverly, U H

1990-01-01

Details a four-week Basic Clinical Pastoral Education Unit. Gives a rationale for the abbreviated unit. Notes positive factors as well as limitations of such an educational experience and urges other CPE supervisors to try the compact approach. Critical responses follow the article.

Capturing microscopic features of bone remodeling into a macroscopic model based on biological rationales of bone adaptation.

PubMed

Kim, Young Kwan; Kameo, Yoshitaka; Tanaka, Sakae; Adachi, Taiji

2017-10-01

To understand Wolff's law, bone adaptation by remodeling at the cellular and tissue levels has been discussed extensively through experimental and simulation studies. For the clinical application of a bone remodeling simulation, it is significant to establish a macroscopic model that incorporates clarified microscopic mechanisms. In this study, we proposed novel macroscopic models based on the microscopic mechanism of osteocytic mechanosensing, in which the flow of fluid in the lacuno-canalicular porosity generated by fluid pressure gradients plays an important role, and theoretically evaluated the proposed models, taking biological rationales of bone adaptation into account. The proposed models were categorized into two groups according to whether the remodeling equilibrium state was defined globally or locally, i.e., the global or local uniformity models. Each remodeling stimulus in the proposed models was quantitatively evaluated through image-based finite element analyses of a swine cancellous bone, according to two introduced criteria associated with the trabecular volume and orientation at remodeling equilibrium based on biological rationales. The evaluation suggested that nonuniformity of the mean stress gradient in the local uniformity model, one of the proposed stimuli, has high validity. Furthermore, the adaptive potential of each stimulus was discussed based on spatial distribution of a remodeling stimulus on the trabecular surface. The theoretical consideration of a remodeling stimulus based on biological rationales of bone adaptation would contribute to the establishment of a clinically applicable and reliable simulation model of bone remodeling.

The trials methodological research agenda: results from a priority setting exercise.

PubMed

Tudur Smith, Catrin; Hickey, Helen; Clarke, Mike; Blazeby, Jane; Williamson, Paula

2014-01-23

Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group's average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were 'Research into methods to boost recruitment in trials' (considered the highest priority), 'Methods to minimise attrition' and 'Choosing appropriate outcomes to measure'. Fifty other topics were included in the list of priorities and consensus was reached that two topics, 'Radiotherapy study designs' and 'Low carbon trials', were not priorities. This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with a focus on topics that will have most impact and relevance.

The trials methodological research agenda: results from a priority setting exercise

PubMed Central

2014-01-01

Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with a focus on topics that will have most impact and relevance. PMID:24456928

Differences between patients' and clinicians' research priorities from the Anaesthesia and Peri-operative Care Priority Setting Partnership.

PubMed

Boney, O; Nathanson, M H; Grocott, M P W; Metcalf, L

2017-09-01

The James Lind Alliance Anaesthesia and Peri-operative Care Priority Setting Partnership was a recent collaborative venture bringing approximately 2000 patients, carers and clinicians together to agree priorities for future research into anaesthesia and critical care. This secondary analysis compares the research priorities of 303 service users, 1068 clinicians and 325 clinicians with experience as service users. All three groups prioritised research to improve patient safety. Service users prioritised research about improving patient experience, whereas clinicians prioritised research about clinical effectiveness. Clinicians who had experience as service users consistently prioritised research more like clinicians than like service users. Individual research questions about patient experience were more popular with patients and carers than with clinicians in all but one case. We conclude that patients, carers and clinicians prioritise research questions differently. All groups prioritise research into patient safety, but service users also favour research into patient experience, whereas clinicians favour research into clinical effectiveness. © 2017 The Association of Anaesthetists of Great Britain and Ireland.

Neuropsychology in a Memory Disorder Clinic.

PubMed

Ruchinskas, Robert A; Cullum, C Munro

2018-05-01

The rationale for and factors related to embedding a neuropsychologist in the midst of a neurology-based memory disorder clinic are discussed. Common conditions encountered are briefly reviewed, along with an evaluation aimed at assisting with differential diagnosis. Advice for neuropsychologists is offered in terms of creating and refining a working model in a neurology clinic and strategies to improve communication and effectiveness are presented.

Priority setting in purchasing.

PubMed

Carroll, G

The NHS cannot deliver full comprehensive health care to all the population. In this article the need to define a range of basic health services is emphasized. Agreement on priorities requires ethical, economic and clinical debate.

Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

PubMed

Bogenschutz, Michael P

2013-03-01

Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials.

Recommendations for research priorities in breast cancer by the Coalition of Cancer Cooperative Groups Scientific Leadership Council: systemic therapy and therapeutic individualization.

PubMed

Sparano, Joseph A; Hortobagyi, Gabriel N; Gralow, Julie R; Perez, Edith A; Comis, Robert L

2010-02-01

Over 9,000 women with breast cancer are enrolled annually on clinical trials sponsored by the National Cancer Institute (NCI), accounting for about one-third of all patients enrolled on NCI-sponsored trials. Thousands are also enrolled on pharmaceutical-sponsored studies. Although breast cancer mortality rates have recently declined for the first time in part due to systemic therapeutic advances, coordinated efforts will be necessary to maintain this trend. The Coalition of Cancer Cooperative Groups convened the Scientific Leadership Council in breast cancer (BC), an expert panel, to identify priorities for future research and current trials with greatest practice-changing potential. Panelists formed a consensus on research priorities for chemoprevention, development and application of molecular markers for predicting therapeutic benefit and toxicity, intermediate markers predictive of therapeutic effect, pathogenesis-based therapeutic approaches, utilization of adaptive designs requiring fewer patients to achieve objectives, special and minority populations, and effects of BC and treatment on patients and families. Panelists identified 13 ongoing studies as High Priority and identified gaps in the current trial portfolio. We propose priorities for current and future clinical breast cancer research evaluating systemic therapies that may serve to improve the efficiency of clinical trials, identify individuals most likely to derive therapeutic benefit, and prioritize therapeutic strategies.

Health Extension and Clinical and Translational Science: An Innovative Strategy for Community Engagement.

PubMed

Kaufman, Arthur; Rhyne, Robert L; Anastasoff, Juliana; Ronquillo, Francisco; Nixon, Marnie; Mishra, Shiraz; Poola, Charlene; Page-Reeves, Janet; Nkouaga, Carolina; Cordova, Carla; Larson, Richard S

Health Extension Regional Officers (HEROs) through the University of New Mexico Health Sciences Center (UNMHSC) help to facilitate university-community engagement throughout New Mexico. HEROs, based in communities across the state, link priority community health needs with university resources in education, service, and research. Researchers' studies are usually aligned with federal funding priorities rather than with health priorities expressed by communities. To help overcome this misalignment, the UNM Clinical and Translational Science Center (CTSC) provides partial funding for HEROs to bridge the divide between research priorities of UNMHSC and health priorities of the state's communities. A bidirectional partnership between HEROs and CTSC researchers was established, which led to: 1) increased community engaged studies through the CTSC, 2) the HERO model itself as a subject of research, 3) a HERO-driven increase in local capacity in scholarship and grant writing, and 4) development of training modules for investigators and community stakeholders on community-engaged research. As a result, 5 grants were submitted, 4 of which were funded, totaling $7,409,002.00, and 3 research articles were published. Health extension can serve as a university-funded, community-based bridge between community health needs and Clinical and Translational Science Award (CTSA) research capacity, opening avenues for translational research. © Copyright 2017 by the American Board of Family Medicine.

Strategic plan for bioenergy research, 1998--2003, the Canadian Forest Service five-year plan: Implementing the Canadian bioenergy research strategy (in English;French)

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

NONE

1998-10-01

This document supersedes the previous one, taking into account changes that have taken place in the CFS Science and Technology (S and T) program structure and organization, and in the structure of the Program of Energy Research and Development, the source of funding for CFS bioenergy research. It explains the rationale and overall objective for the bioenergy research program and briefly reviews the accomplishments to date. It indicates the planning context within which the program operates, states the specific objectives for the period of the plan, and details the strategic priorities developed for this period. Finally, it outlines the implementationmore » process for the plan.« less

[Prospects of systemic radioecology in solving innovative tasks of nuclear power engineering].

PubMed

Spiridonov, S I

2014-01-01

A need of systemic radioecological studies in the strategy developed by the atomic industry in Russia in the XXI century has been justified. The priorities in the radioecology of nuclear power engineering of natural safety associated with the development of the radiation-migration equivalence concept, comparative evaluation of innovative nuclear technologies and forecasting methods of various emergencies have been identified. Also described is an algorithm for the integrated solution of these tasks that includes elaboration of methodological approaches, methods and software allowing dose burdens to humans and biota to be estimated. The rationale of using radioecological risks for the analysis of uncertainties in the environmental contamination impacts,at different stages of the existing and innovative nuclear fuel cycles is shown.

Critical review of norovirus surrogates in food safety research: rationale for considering volunteer studies.

PubMed

Richards, Gary P

2012-03-01

The inability to propagate human norovirus (NoV) or to clearly differentiate infectious from noninfectious virus particles has led to the use of surrogate viruses, like feline calicivirus (FCV) and murine norovirus-1 (MNV), which are propagatable in cell culture. The use of surrogates is predicated on the assumption that they generally mimic the viruses they represent; however, studies are proving this concept invalid. In direct comparisons between FCV and MNV, their susceptibility to temperatures, environmental and food processing conditions, and disinfectants are dramatically different. Differences have also been noted between the inactivation of NoV and its surrogates, thus questioning the validity of surrogates. Considerable research funding is provided globally each year to conduct surrogate studies on NoVs; however, there is little demonstrated benefit derived from these studies in regard to the development of virus inactivation techniques or food processing strategies. Human challenge studies are needed to determine which processing techniques are effective in reducing NoVs in foods. A major obstacle to clinical trials on NoVs is the perception that such trials are too costly and risky, but in reality, there is far more cost and risk in allowing millions of unsuspecting consumers to contract NoV illness each year, when practical interventions are only a few volunteer studies away. A number of clinical trials have been conducted, providing important insights into NoV inactivation. A shift in research priorities from surrogate research to volunteer studies is essential if we are to identify realistic, practical, and scientifically valid processing approaches to improve food safety.

Setting Priorities for Diabetic Retinopathy Clinical Research and Identifying Evidence Gaps.

PubMed

Le, Jimmy T; Hutfless, Susan; Li, Tianjing; Bressler, Neil M; Heyward, James; Bittner, Ava K; Glassman, Adam; Dickersin, Kay

2017-01-01

Prioritizing comparative effectiveness research may contribute to obtaining answers that clinicians perceive they need and may minimize research that could be considered wasteful. Our objective was to identify evidence gaps and set priorities for new systematic reviews and randomized controlled trials for managing diabetic retinopathy (DR), including diabetic macular edema (DME). Cross-sectional study. Diabetic Retinopathy Clinical Research Network (DRCR.net) investigators. We provided recommendations from the American Academy of Ophthalmology's 2012 Preferred Practice Patterns for Diabetic Retinopathy as 91 answerable clinical research questions about intervention effectiveness to 410 DRCR.net investigators to rate each question's importance from 0 (not important) to 10 (very important) using a 2-round Delphi survey and to suggest additional questions. We considered questions as high priority if at least 75% of respondents to both rounds assigned an importance rating of 5 or more in round 2. We also extracted outcome measures relevant to DR and asked respondents to identify those that must be measured in all studies. We mapped Cochrane reviews published up to March 2016 to high-priority clinical research questions. Ranking of importance of each clinical question. Thirty-two individuals completed rounds 1 and 2 and suggested 15 questions. Among the final list of 106 clinical research questions, 22 questions met our definition of high priority: 9 of 22 concerned the effectiveness of anti-VEGF therapy, and 13 of 22 focused on how often patients should be followed up (re-examination) and treatment effectiveness in patients with specific characteristics (e.g., DME). Outcomes that 75% or more of respondents marked as "must be measured in all studies" included visual acuity and visual loss, death of participants, and intraocular pressure. Only 1 prioritized question was associated with conclusive evidence from a Cochrane systematic review. A limited response rate among DRCR.net members identified 22 comparative effectiveness research questions as high priority for the management of DR, including DME, but few were associated with Cochrane reviews. These results support the need of systematic reviews and randomized controlled trials to address evidence gaps.

A study of clinical nursing research priorities in aged care: a Hong Kong perspective.

PubMed

Chang, Esther; Ho, Carey Kit Bing; Yuen, Anders Chi Man; Hatcher, Deborah

2003-10-01

The aim of this study was to identify clinical research priorities in aged care from the perspectives of rehabilitation aged care nurses in Hong Kong. The Delphi method was used whereby 33 registered nurses working in an aged care rehabilitation ward identified 28 research questions pertaining to areas in which nurses could take a leadership role: clinical research that is of highest value to patients and nurse specialists; clinical research which would provide improved community care; facilitate health promotion and disease prevention and be of value to the professional needs of clinical nurses. Study findings have implications and provide direction for clinical nursing research in aged care.

Counseling the Math Anxious

ERIC Educational Resources Information Center

Tobias, Sheila; Donady, Bonnie

1977-01-01

Describes the rationale and mode of operations for a Math Clinic at Wellesley University and Wesleyan College where counselors and math specialists work together to combat "math anxiety," particularly in female students. (HMV)

Drinking in the last chance saloon: luck egalitarianism, alcohol consumption, and the organ transplant waiting list.

PubMed

Albertsen, Andreas

2016-06-01

The scarcity of livers available for transplants forces tough choices upon us. Lives for those not receiving a transplant are likely to be short. One large group of potential recipients needs a new liver because of alcohol consumption, while others suffer for reasons unrelated to their own behaviour. Should the former group receive lower priority when scarce livers are allocated? This discussion connects with one of the most pertinent issues in contemporary political philosophy; the role of personal responsibility in distributive justice. One prominent theory of distributive justice, luck egalitarianism, assesses distributions as just if, and only if, people's relative positions reflect their exercises of responsibility. There is a principled luck egalitarian case for giving lower priority to those who are responsible for their need. Compared to the existing literature favouring such differentiation, luck egalitarianism provides a clearer rationale of fairness, acknowledges the need for individual assessments of responsibility, and requires initiatives both inside and outside of the allocation systems aimed at mitigating the influence from social circumstances. Furthermore, the concrete policies that luck egalitarians can recommend are neither too harsh on those who make imprudent choices nor excessively intrusive towards those whose exercises of responsibility are assessed.

From Global Reconnaissance to Sample Return: A Proposal for a Post-2009 Strategy to Follow the Water on Mars

NASA Technical Reports Server (NTRS)

Clifford, S. M.; George, J. A.; Stoker, C. R.; Briggs, G.

2003-01-01

Since the mid-1990's, the stated strategy of the Mars Exploration Program has been to Follow the Water. Although this strategy has been widely publicized, its degree of influence -- and the logic behind its current implementation (as reflected in mission planning, platform and instrument selection, and allocation of spacecraft resources) remains unclear. In response to this concern, we propose an integrated strategy for the post-2009 exploration of Mars that identifies the scientific objectives, rationale, sequence of missions, and specific investigations, that we believe provides the maximum possible science return by pursuing the most direct, cost-effective, and technically capable approach to following the water. This strategy is based on the orbital identification, high-resolution surface investigation, and ultimate sampling of the highest priority targets: near-surface liquid water and massive ground ice (potentially associated with the discharge of the outlflow channels or the relic of a former ocean). The analysis of such samples, in conjunction with the data acquired by the necessary precursor investigations (to identify the locations and characterize the environments of the optimum sampling sites), is expected to address a majority of the goals and high priority science objectives identified by MEPAG.

Residents' Yard Choices and Rationales in a Desert City: Social Priorities, Ecological Impacts, and Decision Tradeoffs

NASA Astrophysics Data System (ADS)

Larson, Kelli L.; Casagrande, David; Harlan, Sharon L.; Yabiku, Scott T.

2009-11-01

As a dominant land use in urban ecosystems, residential yards impact water and other environmental resources. Converting thirsty lawns into alternative landscapes is one approach to water conservation, yet barriers such as cultural norms reinforce the traditional lawn. Meanwhile, the complex social and ecological implications of yard choices complicate programs aimed at changing grass and other yard features for particular purposes. In order to better understand individual landscape decisions, we qualitatively examined residents’ rationales for their preferred yard types in the desert metropolis of Phoenix, Arizona. After briefly presenting landscape choices across two survey samples, the dominant reasons for preferences are discussed: appearance, maintenance, environment, recreation, microclimate, familiarity, and health/safety. Three broader analytical themes emerged from these descriptive codes: (1) residents’ desires for attractive, comfortable landscapes of leisure encompassing pluralistic tastes, lifestyles, and perceptions; (2) the association of environmental benefits and impacts with different landscape types involving complex social and ecological tradeoffs; and (3) the cultural legacies evident in modern landscape choices, especially in terms of a dichotomous human-nature worldview among long-time residents of the Phoenix oasis. Given these findings, programs aimed at landscape change must recognize diverse preferences and rationalization processes, along with the perceived versus actual impacts and tradeoffs of varying yard alternatives.

Priority setting in guideline development: article 2 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Atkins, David; Perez-Padilla, Rogelio; Macnee, William; Buist, A Sonia; Cruz, Alvaro A

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. Priority setting is an essential component of developing clinical practice guidelines informed by the best available research evidence. It ensures that resources and attention are devoted to those areas in which clinical recommendations will provide the greatest benefit to patients, clinicians, and policy makers. This is the second of a series of 14 articles that methodologists and researchers from around the world prepared to advise guideline developers in respiratory and other diseases. This review focuses on priority setting, addressing five key questions. In this review, we addressed the following questions. (1) At which steps of guideline development should priorities be considered? (2) How do we create an initial list of potential topics within the guideline? (3) What criteria should be used to establish priorities? (4) What parties should be involved and what processes should be used to set priorities? (5)What are the potential challenges of setting priorities? We updated an existing review on priority setting, and searched PubMed and other databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on available evidence, our own experience working with guideline developers, and workshop discussions. Existing literature on priority setting largely applies to identifying priorities for which guidelines to develop rather than setting priorities for recommendations within a guideline. Nonetheless, there is substantial consensus about the general factors that should be considered in setting priorities. These include the burdens and costs of illness, potential impact of a recommendation, identified deficits or weak points in practice, variation or uncertainty in practice, and availability of evidence. The input of a variety of stakeholders is useful in setting priorities, although informal consultation is used more often than formal methods. Processes for setting priorities remains poorly described in most guidelines.

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial.

PubMed

Dobson, Rosie; Whittaker, Robyn; Jiang, Yannan; Shepherd, Matthew; Maddison, Ralph; Carter, Karen; Cutfield, Richard; McNamara, Catherine; Khanolkar, Manish; Murphy, Rinki

2016-04-02

Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial. A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction. This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment. Australian New Zealand Clinical Trials Registry: ACTRN12614001232628 .

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.

A Developmental Perspective on Assessment of Infants with Clefts and Related Disorders.

ERIC Educational Resources Information Center

Savage, Hallie E.; And Others

1994-01-01

This article presents a rationale for comprehensive developmental assessment for infants with cleft palates/lips and related disorders. The assessment model is based on risk factors influencing early development and on clinical research on developmental outcomes. Implications on the clinical assessment process and early intervention are discussed.…

77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... trials and device study design. Date and Time: The public workshop will be held on November 27, 2012... problem for PRO instruments. There have been various methodological approaches to determine MCID for... rationales for regulatory guidance of clinical trials and device study design. Approximately 45 days after...

A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

ERIC Educational Resources Information Center

Kerson, Cynthia

2013-01-01

Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

Uses of Children's Make-Believe Play in Family Therapy: Theory and Clinical Examples.

ERIC Educational Resources Information Center

Ariel, Shlomo; And Others

1985-01-01

Presents and illustrates by clinical examples a theoretical framework for developing, describing, and analyzing family-therapeutic techniques involving make-believe play. Induces specifications of the therapeutic goals served by the technique and its procedural details and an analysis of its rationale. Draws on a definition of the concept…

Including internal mammary lymph nodes in radiation therapy for synchronous bilateral breast cancer: an international survey of treatment technique and clinical priorities.

PubMed

Roumeliotis, M; Long, K; Phan, T; Graham, D; Quirk, S

2018-06-05

The aim of this study was to understand the international standard practice for radiation therapy treatment techniques and clinical priorities for institutions including the internal mammary lymph nodes (IMLNs) in the target volume for patients with synchronous bilateral breast cancer. An international survey was developed to include questions that would provide awareness of favored treatment techniques, treatment planning and delivery resource requirements, and the clinical priorities that may lead to the utilization of preferred treatment techniques. Of the 135 respondents, 82 indicated that IMLNs are regularly included in the target volume for radiation therapy (IMLN-inclusion) when the patient is otherwise generally indicated for regional nodal irradiation. Of the 82 respondents that regularly include IMLNs, five were removed as those respondents do not treat this population synchronously. Of the 77 respondents, institutional standard of care varied significantly, though VMAT (34%) and combined static photon and electron fields (21%) were the most commonly utilized techniques. Respondents did preferentially select target volume coverage (70%) as the most important clinical priority, followed by normal tissue sparing (25%). The results of the survey indicate that the IMLN-inclusion for radiation therapy has not yet been comprehensively adopted. As well, no consensus on best practice for radiation therapy treatment techniques has been reached.

Getting inside acupuncture trials - Exploring intervention theory and rationale

PubMed Central

2011-01-01

Background Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected) is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture). Methods Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer. Results When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue. Conclusion Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the intervention. We advocate using this framework to aid reporting, along with further testing and refinement of the framework. PMID:21414187

What nursing students reveal about and learn from mentors when using stories of clinical practice.

PubMed

Edwards, Sharon

2017-02-27

Aim This article considers findings from a narrative research analysis that illustrate what nursing students can reveal about being mentored through their stories of clinical practice experience. The aim is to advocate the use of stories as tools to assist mentors in their roles, and to express to them students' concerns, sensitivities and priorities about clinical placement experiences. The findings are extracted from the author's unpublished doctoral thesis Learning from Practice: The Value of Story in Nurse Education ( Edwards 2013 ). Method The data are drawn from nursing students' stories about clinical practice experiences when engaged in the care of patients, and their perceived learning from them. Results Findings suggest stories can help develop understanding of nursing students' concerns, sensitivities and priorities, and can support mentors' important roles in students' learning. Conclusion The article illustrates the value of stories as learning tools in the workplace and, by looking at nursing students' stories about clinical practice, shows that paying attention to their concerns, sensitivities and priorities can improve the already significant role played by mentors in student learning.

Transcranial magnetic stimulation as an investigative tool for motor dysfunction and recovery in stroke: an overview for neurorehabilitation clinicians

PubMed Central

Cortes, Mar; Black-Schaffer, Randie M; Edwards, Dylan J

2012-01-01

Rationale An improved understanding of motor dysfunction and recovery after stroke has important clinical implications that may lead to the design of more effective rehabilitation strategies for patients with hemiparesis. Scope Transcranial magnetic stimulation (TMS) is a safe and painless tool that has been used in conjunction with other existing diagnostic tools to investigate motor pathophysiology in stroke patients. Since TMS emerged over two decades ago, its application in clinical and basic neuroscience has expanded worldwide. TMS can quantify the corticomotor excitability properties of clinically affected and unaffected muscles, and probe local cortical networks, as well as remote but functionally related areas. This provides novel insight into the physiology of neural circuits underlying motor dysfunction, and brain reorganization during the motor recovery process. This important tool needs to be used with caution by clinical investigators, its limitations need to be understood and the results should be interpreted along with clinical evaluation in this patient population. Summary In this review, we provide an overview of the rationale, implementation and limitations of TMS to study stroke motor physiology. This knowledge may be useful to guide future rehabilitation treatments by assessing and promoting functional plasticity. PMID:22624621

Effective stakeholder participation in setting research priorities using a Global Evidence Mapping approach.

PubMed

Clavisi, Ornella; Bragge, Peter; Tavender, Emma; Turner, Tari; Gruen, Russell L

2013-05-01

We present a multistep process for identifying priority research areas in rehabilitation and long-term care of traumatic brain-injured (TBI) patients. In particular, we aimed to (1) identify which stakeholders should be involved; (2) identify what methods are appropriate; (3) examine different criteria for the generation of research priority areas; and (4) test the feasibility of linkage and exchange among researchers, decision makers, and other potential users of the research. Potential research questions were identified and developed using an initial scoping meeting and preliminary literature search, followed by a facilitated mapping workshop and an online survey. Identified research questions were then prioritized against specific criteria (clinical importance, novelty, and controversy). Existing evidence was then mapped to the high-priority questions using usual processes for search, screening, and selection. A broad range of stakeholders were then brought together at a forum to identify priority research themes for future research investment. Using clinical and research leaders, smaller targeted planning workshops prioritized specific research projects for each of the identified themes. Twenty-six specific questions about TBI rehabilitation were generated, 14 of which were high priority. No one method identified all high-priority questions. Methods that relied solely on the views of clinicians and researchers identified fewer high-priority questions compared with methods that used broader stakeholder engagement. Evidence maps of these high-priority questions yielded a number of evidence gaps. Priority questions and evidence maps were then used to inform a research forum, which identified 12 priority themes for future research. Our research demonstrates the value of a multistep and multimethod process involving many different types of stakeholders for prioritizing research to improve the rehabilitation outcomes of people who have suffered TBI. Enhancing stakeholder representation can be augmented using a combination of methods and a process of linkage and exchange. This process can inform decisions about prioritization of research areas. Copyright © 2013 Elsevier Inc. All rights reserved.

GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and rationale.

PubMed

Welch, Vivian A; Akl, Elie A; Guyatt, Gordon; Pottie, Kevin; Eslava-Schmalbach, Javier; Ansari, Mohammed T; de Beer, Hans; Briel, Matthias; Dans, Tony; Dans, Inday; Hultcrantz, Monica; Jull, Janet; Katikireddi, Srinivasa Vittal; Meerpohl, Joerg; Morton, Rachael; Mosdol, Annhild; Petkovic, Jennifer; Schünemann, Holger J; Sharaf, Ravi N; Singh, Jasvinder A; Stanev, Roger; Tonia, Thomy; Tristan, Mario; Vitols, Sigurd; Watine, Joseph; Tugwell, Peter

2017-10-01

This article introduces the rationale and methods for explicitly considering health equity in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for development of clinical, public health, and health system guidelines. We searched for guideline methodology articles, conceptual articles about health equity, and examples of guidelines that considered health equity explicitly. We held three meetings with GRADE Working Group members and invited comments from the GRADE Working Group listserve. We developed three articles on incorporating equity considerations into the overall approach to guideline development, rating certainty, and assembling the evidence base and evidence to decision and/or recommendation. Clinical and public health guidelines have a role to play in promoting health equity by explicitly considering equity in the process of guideline development. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Self-preservation: an argument for therapeutic cloning, and a strategy for fostering respect for moral integrity.

PubMed

Mahowald, Mary B

2004-01-01

The issues of human cloning and stem cell retrieval are inseparable in circumstances in which the rationale of self-preservation may be invoked as a negative right. I apply this rationale to a hypothetical case in which cloning is necessary to preserve the bodily integrity or life of an individual. Self-preservation as moral integrity is examined in a narrower context, i.e., as applicable to those for whom deliberate termination of embryonic life is morally-problematic. This issue is addressed through comparison with two paradigms commonly used in support of clinical practice: the distinction between letting die and killing, and the permissibility of vital organ retrieval after death. Although these paradigms are questionable in their own right, they offer a rationale by which scientists and clinicians may respect the negative right to moral integrity of those with whom they disagree.

Setting stroke research priorities: The consumer perspective.

PubMed

Sangvatanakul, Pukkaporn; Hillege, Sharon; Lalor, Erin; Levi, Christopher; Hill, Kelvin; Middleton, Sandy

2010-12-01

To test a method of engaging consumers in research priority-setting using a quantitative approach and to determine consumer views on stroke research priorities for clinical practice recommendations with lower levels of evidence (Level III and Level IV) and expert consensus opinion as published in the Australian stroke clinical practice guidelines. Survey Urban community Eighteen stroke survivors (n = 12) and carers (n = 6) who were members of the "Working Aged Group - Stroke" (WAGS) consumer support group. Phase I: Participants were asked whether recommendations were "worth" researching ("yes" or "no"); and, if researched, what potential impact they likely would have on patient outcomes. Phase II: Participants were asked to rank recommendations rated by more than 75% of participants in Phase I as "worth" researching and "highly likely" or "likely" to generate research with a significant effect on patient outcomes (n = 13) in order of priority for future stroke research. All recommendations were rated by at least half (n = 9, 50%) of participants as "worth" researching. The majority (67% to 100%) rated all recommendations as "highly likely" or "likely" that research would have a significant effect on patient outcomes. Thirteen out of 20 recommendations were ranked for their research priorities. Recommendations under the topic heading Getting to hospital were ranked highest and Organization of care and Living with stroke were ranked as a lower priority for research. This study provided an example of how to involve consumers in research priority setting successfully using a quantitative approach. Stroke research priorities from the consumer perspective were different from those of health professionals, as published in the literature; thus, consumer opinion should be considered when setting research priorities. Copyright © 2010 Society for Vascular Nursing, Inc. Published by Mosby, Inc. All rights reserved.

Binge Eating among Women Veterans in Primary Care: Comorbidities and Treatment Priorities.

PubMed

Rosenbaum, Diane L; Kimerling, Rachel; Pomernacki, Alyssa; Goldstein, Karen M; Yano, Elizabeth M; Sadler, Anne G; Carney, Diane; Bastian, Lori A; Bean-Mayberry, Bevanne A; Frayne, Susan M

2016-01-01

Little is known about the clinical profile and treatment priorities of women with binge eating disorder (BED), a diagnosis new to the fifth edition of Diagnostic and Statistical Manual of Mental Disorders. We identified comorbidities and patients' treatment priorities, because these may inform implementation of clinical services. Data were collected from women veteran primary care patients. Analyses compared those who screened positive for BED (BED+), and those without any binge eating symptoms (BED-). Frequencies of comorbid medical and psychological disorders were high in the BED+ group. The BED+ group's self-identified most common treatment priorities were mood concerns (72.2%), weight loss (66.7%), and body image/food issues (50%). Among those with obesity, a greater proportion of the BED+ group indicated body image/food issues was their top treatment priority (12.9% vs. 2.8%; p < .01), suggesting that these patients may be more apt to seek treatment beyond weight management for their problematic eating patterns. Women primary care patients with BED demonstrate high medical and psychological complexity; their subjective treatment priorities often match objective needs. These findings may inform the development of targeted BED screening practices for women with obesity in primary care settings, and the eventual adoption of patient-centered BED treatment resources. Published by Elsevier Inc.

The role of pulse oximetry in chiropractic practice: a rationale for its use

PubMed Central

Hall, Michael W.; Jensen, Anne M.

2012-01-01

Objective Pulse oximetry is used regularly to assess oxygen saturation levels. The objective of this commentary is to discuss a rationale for using pulse oximetry in chiropractic practice. Discussion Pulse oximetry may offer doctors of chiropractic a way to monitor patients' oxygen saturation levels. Quantification of saturation values with heart rate may give clinical aid to the management of chiropractic patients. Markedly reduced saturation levels may necessitate medical referral, whereas mildly reduced levels could lead to changes in chiropractic management. Conclusions Pulse oximetry has the potential to be an integral part of chiropractic practice. PMID:23204957

Quality and cost improvement of healthcare via complementary measurement and diagnosis of patient general health outcome using electronic health record data: research rationale and design.

PubMed

Stusser, Rodolfo J; Dickey, Richard A

2013-12-01

In this evolving 'third era of health', one of the US Health Care Reform Act's goals is to effectively facilitate the primary care physician's ability to better diagnose and manage the health outcome of the outpatient. That goal must include research on the complementary quantitative-qualitative assessment and rating of the patient's health status. This paper proposes an overview of the rationale and design of a research program for a balanced measurement and diagnostic clinical decision support system (CDSS) of the changing general health status of the patient -including disease- using electronic health record (EHR) data. The rationale, objectives, health metric-diagnostic tools architecture, simulation-optimization, and clinical trials are outlined. Resources, time frames, costs, feasibility, healthcare benefits and data-integration of the project are delineated. The basis and components of the research program to achieve an automated-CDSS to complement physician's clinical judgment, calculating a mathematical 'health equation' from each patient's EHR database, assisting physician-patient collaboration to diagnose, and improve general health outcomes is described. Use of multiple dimensional index, ways of classification, and causal factors' assessments, to arrive at the EHR-based CDSS algorithm-software providing a general health level and state rating of the patient are proposed. Its application could provide a compass for the general practitioner's best choice and use of the myriad of healthcare educational and technological options available with lower costs for everyday clinical practice and research. It could advance the approaches and focus of the 'eras of diseases', to the promising 'era of health', in an integrated, general approach to 'health.'

Global Health and Emergency Care: Defining Clinical Research Priorities.

PubMed

Hansoti, Bhakti; Aluisio, Adam R; Barry, Meagan A; Davey, Kevin; Lentz, Brian A; Modi, Payal; Newberry, Jennifer A; Patel, Melissa H; Smith, Tricia A; Vinograd, Alexandra M; Levine, Adam C

2017-06-01

Despite recent strides in the development of global emergency medicine (EM), the field continues to lag in applying a scientific approach to identifying critical knowledge gaps and advancing evidence-based solutions to clinical and public health problems seen in emergency departments (EDs) worldwide. Here, progress on the global EM research agenda created at the 2013 Academic Emergency Medicine Global Health and Emergency Care Consensus Conference is evaluated and critical areas for future development in emergency care research internationally are identified. A retrospective review of all studies compiled in the Global Emergency Medicine Literature Review (GEMLR) database from 2013 through 2015 was conducted. Articles were categorized and analyzed using descriptive quantitative measures and structured data matrices. The Global Emergency Medicine Think Tank Clinical Research Working Group at the Society for Academic Emergency Medicine 2016 Annual Meeting then further conceptualized and defined global EM research priorities utilizing consensus-based decision making. Research trends in global EM research published between 2013 and 2015 show a predominance of observational studies relative to interventional or descriptive studies, with the majority of research conducted in the inpatient setting in comparison to the ED or prehospital setting. Studies on communicable diseases and injury were the most prevalent, with a relative dearth of research on chronic noncommunicable diseases. The Global Emergency Medicine Think Tank Clinical Research Working Group identified conceptual frameworks to define high-impact research priorities, including the traditional approach of using global burden of disease to define priorities and the impact of EM on individual clinical care and public health opportunities. EM research is also described through a population lens approach, including gender, pediatrics, and migrant and refugee health. Despite recent strides in global EM research and a proliferation of scholarly output in the field, further work is required to advocate for and inform research priorities in global EM. The priorities outlined in this paper aim to guide future research in the field, with the goal of advancing the development of EM worldwide. © 2017 by the Society for Academic Emergency Medicine.

Criteria for choosing clinically effective glaucoma treatment: A discussion panel consensus

PubMed Central

Thygesen, John; Burk, Reinhard; Carassa, Roberto; Crichton, Andrew; Goñi, Francisco Javier; Menage, Mitch; Miglior, Stefano; Montgomery, Donald; Nordmann, John-Philippe; Roberts, Tim; Singh, Kuldev

2007-01-01

Abstract Background: In the clinical management of patients at risk for or diagnosed with primary open-angle glaucoma (POAG), the aim of medical treatment is to reduce intraocular pressure (IOP) and then maintain it over time at a level that preserves both the structure and function of the optic nerve. Objective: The objective of this report was to establish a consensus on the criteria that should be used to determine the characteristics of IOP-lowering medication. Methods: Discussion was held among a panel of 12 physicians considered to be experts in glaucoma to develop a consensus on the criteria used by them to determine the characteristics of the IOP-lowering medication chosen for initial monotherapy and adjunctive treatment of ocular hypertension (OHT) or POAG. Consensus development combined available evidence and the impressions of these physicians regarding the clinical effectiveness of IOP-lowering medication for OHT and POAG. Once the panel identified the criteria, the order of priority and the relative importance of these criteria were then established in the setting of 3 risk categories (low, medium, and high) for a patient to experience significant visual disability from glaucoma over their expected life span. Results: The panel identified 5 criteria to determine the characteristics of IOP-lowering medication for OHT and POAG: IOP-lowering effect, systemic adverse events (AEs), ocular tolerability, compliance/administration, and cost of treatment. IOP-lowering effect was consistently ranked as the highest priority and cost as the lowest. The priority of compliance/administration did not vary by clinical situation. Systemic AEs and ocular tolerability were ranked as higher priorities in initial monotherapy than in adjunctive treatment and ranked lower as the risk for visual disability increased. The priority given to the criteria used to determine clinical effectiveness varied both with the risk for functional vision loss from glaucoma and whether initial monotherapy or adjunctive treatment was being considered. Conclusion: Glaucoma treatment should be assessed with regard to the need not only to lower IOP but also to minimize systemic and ocular AEs, promote patient compliance, and minimize cost. The order of priority and relative importance given to these treatment criteria will vary as part of individualizing patient care. PMID:24683204

A Distance Education Model for Training Substance Abuse Treatment Providers in Cognitive-Behavioral Therapy

ERIC Educational Resources Information Center

Watson, Donnie W.; Rawson, Richard R.; Rataemane, Solomon; Shafer, Michael S.; Obert, Jeanne; Bisesi, Lorrie; Tanamly, Susie

2003-01-01

This paper presents a rationale for the use of a distance education approach in the clinical training of community substance abuse treatment providers. Developing and testing new approaches to the clinical training and supervision of providers is important in the substance abuse treatment field where new information is always available. A…

Characterizing Safety-net Providers’ HPV Vaccine Recommendations to Undecided Parents: A Pilot Study

PubMed Central

Shay, L. Aubree; Street, Richard L.; Baldwin, Austin S.; Marks, Emily G.; Lee, Simon Craddock; Higashi, Robin T.; Skinner, Celette Sugg; Fuller, Sobha; Persaud, Donna; Tiro, Jasmin A.

2016-01-01

Objective Although provider recommendation is a key predictor of HPV vaccination, how providers verbalize recommendations particularly strong ones is unknown. We developed a tool to describe strength and content of provider recommendations. Methods We used electronic health records to identify unvaccinated adolescents with appointments at six safety-net clinics in Dallas, Texas. Clinic visit audio-recordings were qualitatively analyzed to identify provider recommendation types (presumptive vs. participatory introduction; strong vs. weak), describe content communicated, and explore patterns between recommendation type and vaccination. Results We analyzed 43 audio-recorded discussions between parents and 12 providers. Most providers used a participatory introduction (42 discussions) and made weak recommendations (24 discussions) by using passive voice or adding a qualification (e.g., not school required). Few providers (11 discussions) gave strong recommendations (clear, personally-owned endorsement). HPV vaccination was lowest for those receiving only weak recommendations and highest when providers coupled the recommendation with an adjacent rationale. Conclusion Our new tool provides initial evidence of how providers undercut their recommendations through qualifications or support them with a rationale. Most providers gave weak HPV vaccine recommendations and used a participatory introduction. Practice Implications Providers would benefit from communication skills training on how to make explicit recommendations with an evidence-based rationale. PMID:27401828

Camera memory study for large space telescope. [charge coupled devices

NASA Technical Reports Server (NTRS)

Hoffman, C. P.; Brewer, J. E.; Brager, E. A.; Farnsworth, D. L.

1975-01-01

Specifications were developed for a memory system to be used as the storage media for camera detectors on the large space telescope (LST) satellite. Detectors with limited internal storage time such as intensities charge coupled devices and silicon intensified targets are implied. The general characteristics are reported of different approaches to the memory system with comparisons made within the guidelines set forth for the LST application. Priority ordering of comparisons is on the basis of cost, reliability, power, and physical characteristics. Specific rationales are provided for the rejection of unsuitable memory technologies. A recommended technology was selected and used to establish specifications for a breadboard memory. Procurement scheduling is provided for delivery of system breadboards in 1976, prototypes in 1978, and space qualified units in 1980.

Opinions of sports clinical practice chiropractors, with sports specialty training and those without, about chiropractic research priorities in sports health care: a centering resonance analysis

PubMed Central

Lee, Alexander D; Szabo, Kaitlyn; McDowell, Kirstie; Granger, Sydney

2016-01-01

Introduction: A Canadian sports chiropractic research agenda has yet to be defined. The Delphi method can be utilized to achieve this purpose; however, the sample of experts who participate can influence the results. To better inform sample selection for future research agenda development, we set out to determine if differences in opinions about research priorities exist between chiropractors who have their sports specialty designation and those who do not. Methods: Fifteen sports clinical practice chiropractors who have their sports fellowship designation and fifteen without, were interviewed with a set of standardized questions about sports chiropractic research priorities. A centering resonance analysis and cluster analysis were conducted on the interview responses. Results: The two practitioner groups differed in their opinions about the type of research that they would like to see conducted, the research that would impact their clinical practice the most, and where they believed research was lacking. However, both groups were similar in their opinions about research collaborations. Conclusion: Sports clinical practice chiropractors, with their sports specialty designation and those without, differed in their opinions about sports chiropractic research priorities; however, they had similar opinions about research collaborations. These results suggest that it may be important to sample from both practitioner groups in future studies aimed at developing research agendas for chiropractic research in sport. PMID:28065995

Patient needs and research priorities in the enteral nutrition market - a quantitative prioritization analysis.

PubMed

Weenen, T C; Jentink, A; Pronker, E S; Commandeur, H R; Claassen, E; Boirie, Y; Singer, P

2014-10-01

A quantitative systematic identification and prioritization of unmet needs and research opportunities in relation to enteral nutrition was conducted by means of a tailor-made health research prioritization process. The research objectives were reached by conducting qualitative interviews followed by quantitative questionnaires targeting enteral nutrition key opinion leaders (KOLs). (1) Define disease areas that deserve more research attention; (2) Rank importance of product characteristics of tube feeding (TF) and oral nutritional supplements (ONS); (3) Assess involvement of KOLs in enteral nutrition R&D process. KOLs ranked three product characteristics and three disease areas that deserve additional research attention. From these, overall priority scores were calculated by multiplying ranks for both product characteristics and disease areas. 17 qualitative interviews were conducted and 77 questionnaires (response rate 35%) were completed and returned. (1) Disease areas in ONS and TF with highest priorities are: ONS: general malnutrition & geriatrics, TF: intensive care. (2) TF product characteristics with highest priorities are: composition and clinical evidence from a KOL perspective; tolerance and ease of use from a patient perspective. ONS product characteristics with highest priorities are: composition, clinical evidence and taste from a KOL perspective; taste from a patient perspective. We find a high discrepancy between product characteristic prioritization from a KOL and patient perspective. (3) Although 62% of all KOLs give advice to enteral nutrition companies on patient needs, they under-influence the setting of research priorities by enteral nutrition companies. This study provides a systematic approach to achieve research prioritization in enteral nutrition. In addition to providing new directions for enteral nutrition research and development, this study highlights the relevance of involving KOLs in the identification of research priorities as they have the ability to provide a balanced view of the unmet patient needs. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics.

PubMed

Abraham, William T; Burkhoff, Daniel; Nademanee, Koonlawee; Carson, Peter; Bourge, Robert; Ellenbogen, Kenneth A; Parides, Michael; Kadish, Alan

2008-10-01

Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.

[Risk, uncertainty and ignorance in medicine].

PubMed

Rørtveit, G; Strand, R

2001-04-30

Exploration of healthy patients' risk factors for disease has become a major medical activity. The rationale behind primary prevention through exploration and therapeutic risk reduction is not separated from the theoretical assumption that every form of uncertainty can be expressed as risk. Distinguishing "risk" (as quantitative probabilities in a known sample space), "strict uncertainty" (when the sample space is known, but probabilities of events cannot be quantified) and "ignorance" (when the sample space is not fully known), a typical clinical situation (primary risk of coronary disease) is analysed. It is shown how strict uncertainty and sometimes ignorance can be present, in which case the orthodox decision theoretical rationale for treatment breaks down. For use in such cases, a different ideal model of rationality is proposed, focusing on the patient's considered reasons. This model has profound implications for the current understanding of medical professionalism as well as for the design of clinical guidelines.

Perioperative fluid therapy: defining a clinical algorithm between insufficient and excessive.

PubMed

Strunden, Mike S; Tank, Sascha; Kerner, Thoralf

2016-12-01

In the perioperative scenario, adequate fluid and volume therapy is a challenging task. Despite improved knowledge on the physiology of the vascular barrier function and its respective pathophysiologic disturbances during the perioperative process, clear-cut therapeutic principles are difficult to implement. Neglecting the physiologic basis of the vascular barrier and the cardiovascular system, numerous studies proclaiming different approaches to fluid and volume therapy do not provide a rationale, as various surgical and patient risk groups, and different fluid regimens combined with varying hemodynamic measures and variable algorithms led to conflicting results. This review refers to the physiologic basis and answers questions inseparably conjoined to a rational approach to perioperative fluid and volume therapy: Why does fluid get lost from the vasculature perioperatively? Whereto does it get lost? Based on current findings and rationale considerations, which fluid replacement algorithm could be implemented into clinical routine? Copyright © 2016 Elsevier Inc. All rights reserved.

In vivo animal stroke models: a rationale for rodent and non-human primate models

PubMed Central

Tajiri, Naoki; Dailey, Travis; Metcalf, Christopher; Mosley, Yusef I.; Lau, Tsz; Staples, Meaghan; van Loveren, Harry; Kim, Seung U.; Yamashima, Tetsumori; Yasuhara, Takao; Date, Isao; Kaneko, Yuji; Borlongan, Cesario V.

2013-01-01

On average, every four minutes an individual dies from a stroke, accounting for 1 out of every 18 deaths in the United States. Apporximately 795,000 Americans have a new or recurrent stroke each year, with just over 600,000 of these being first attack [1]. There have been multiple animal models of stroke demonstrating that novel therapeutics can help improve the clinical outcome. However, these results have failed to show the same outcomes when tested in human clinical trials. This review will discuss the current in vivo animal models of stroke, advantages and limitations, and the rationale for employing these animal models to satisfy translational gating items for examination of neuroprotective, as well as neurorestorative strategies in stroke patients. An emphasis in the present discussion of therapeutics development is given to stem cell therapy for stroke. PMID:23682299

How Primary Care Providers Talk to Patients about Genome Sequencing Results: Risk, Rationale, and Recommendation.

PubMed

Vassy, Jason L; Davis, J Kelly; Kirby, Christine; Richardson, Ian J; Green, Robert C; McGuire, Amy L; Ubel, Peter A

2018-06-01

Genomics will play an increasingly prominent role in clinical medicine. To describe how primary care physicians (PCPs) discuss and make clinical recommendations about genome sequencing results. Qualitative analysis. PCPs and their generally healthy patients undergoing genome sequencing. Patients received clinical genome reports that included four categories of results: monogenic disease risk variants (if present), carrier status, five pharmacogenetics results, and polygenic risk estimates for eight cardiometabolic traits. Patients' office visits with their PCPs were audio-recorded, and summative content analysis was used to describe how PCPs discussed genomic results. For each genomic result discussed in 48 PCP-patient visits, we identified a "take-home" message (recommendation), categorized as continuing current management, further treatment, further evaluation, behavior change, remembering for future care, or sharing with family members. We analyzed how PCPs came to each recommendation by identifying 1) how they described the risk or importance of the given result and 2) the rationale they gave for translating that risk into a specific recommendation. Quantitative analysis showed that continuing current management was the most commonly coded recommendation across results overall (492/749, 66%) and for each individual result type except monogenic disease risk results. Pharmacogenetics was the most common result type to prompt a recommendation to remember for future care (94/119, 79%); carrier status was the most common type prompting a recommendation to share with family members (45/54, 83%); and polygenic results were the most common type prompting a behavior change recommendation (55/58, 95%). One-fifth of recommendation codes associated with monogenic results were for further evaluation (6/24, 25%). Rationales for these recommendations included patient context, family context, and scientific/clinical limitations of sequencing. PCPs distinguish substantive differences among categories of genome sequencing results and use clinical judgment to justify continuing current management in generally healthy patients with genomic results.

Caries Risk Assessment for Determination of Focus and Intensity of Prevention in a Dental School Clinic.

ERIC Educational Resources Information Center

Dodds, Michael W. J.; Suddick, Richard P.

1995-01-01

A study at the University of Texas, San Antonio's dental school resulted in development of a system of caries risk assessment, applied to all undergraduate clinic patients. The rationale, structure, elements, and application of the system are outlined, and course content supporting the system is noted. Need for validation and other improvements is…

[Cooperative Cardiovascular Disease Research Network (RECAVA)].

PubMed

García-Dorado, David; Castro-Beiras, Alfonso; Díez, Javier; Gabriel, Rafael; Gimeno-Blanes, Juan R; Ortiz de Landázuri, Manuel; Sánchez, Pedro L; Fernández-Avilés, Francisco

2008-01-01

Today, cardiovascular disease is the principal cause of death and hospitalization in Spain, and accounts for an annual healthcare budget of more than 4000 million euros. Consequently, early diagnosis, effective prevention, and the optimum treatment of cardiovascular disease present a significant social and healthcare challenge for the country. In this context, combining all available resources to increase the efficacy and healthcare benefits of scientific research is a priority. This rationale prompted the establishment of the Spanish Cooperative Cardiovascular Disease Research Network, or RECAVA (Red Temática de Investigación Cooperativa en Enfermedades Cardiovasculares), 5 years ago. Since its foundation, RECAVA's activities have focused on achieving four objectives: a) to facilitate contacts between basic, clinical and epidemiological researchers; b) to promote the shared use of advanced technological facilities; c) to apply research results to clinical practice, and d) to train a new generation of translational cardiovascular researchers in Spain. At present, RECAVA consists of 41 research groups and seven shared technological facilities. RECAVA's research strategy is based on a scientific design matrix centered on the most important cardiovascular processes. The level of RECAVA's research activity is reflected in the fact that 28 co-authored articles were published in international journals during the first six months of 2007, with each involving contributions from at least two groups in the network. Finally, RECAVA also participates in the work of the Spanish National Center for Cardiovascular Research, or CNIC (Centro Nacional de Investigación Cardiovascular), and some established Biomedical Research Network Centers, or CIBER (Centros de Investigación Biomédica en RED), with the aim of consolidating the development of a dynamic multidisciplinary research framework that is capable of meeting the growing challenge that cardiovascular disease will present in the future.

Importance of mixed methods in pragmatic trials and dissemination and implementation research.

PubMed

Albright, Karen; Gechter, Katherine; Kempe, Allison

2013-01-01

With increased attention to the importance of translating research to clinical practice and policy, recent years have seen a proliferation of particular types of research, including pragmatic trials and dissemination and implementation research. Such research seeks to understand how and why interventions function in real-world settings, as opposed to highly controlled settings involving conditions not likely to be repeated outside the research study. Because understanding the context in which interventions are implemented is imperative for effective pragmatic trials and dissemination and implementation research, the use of mixed methods is critical to understanding trial results and the success or failure of implementation efforts. This article discusses a number of dimensions of mixed methods research, utilizing at least one qualitative method and at least one quantitative method, that may be helpful when designing projects or preparing grant proposals. Although the strengths and emphases of qualitative and quantitative approaches differ substantially, methods may be combined in a variety of ways to achieve a deeper level of understanding than can be achieved by one method alone. However, researchers must understand when and how to integrate the data as well as the appropriate order, priority, and purpose of each method. The ability to demonstrate an understanding of the rationale for and benefits of mixed methods research is increasingly important in today's competitive funding environment, and many funding agencies now expect applicants to include mixed methods in proposals. The increasing demand for mixed methods research necessitates broader methodological training and deepened collaboration between medical, clinical, and social scientists. Although a number of challenges to conducting and disseminating mixed methods research remain, the potential for insight generated by such work is substantial. Copyright © 2013 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Marmosets as model species in neuroscience and evolutionary anthropology.

PubMed

Burkart, Judith M; Finkenwirth, Christa

2015-04-01

Marmosets are increasingly used as model species by both neuroscientists and evolutionary anthropologists, but with a different rationale for doing so. Whereas neuroscientists stress that marmosets share many cognitive traits with humans due to common descent, anthropologists stress those traits shared with marmosets - and callitrichid monkeys in general - due to convergent evolution, as a consequence of the cooperative breeding system that characterizes both humans and callitrichids. Similarities in socio-cognitive abilities due to convergence, rather than homology, raise the question whether these similarities also extend to the proximate regulatory mechanisms, which is particularly relevant for neuroscientific investigations. In this review, we first provide an overview of the convergent adaptations to cooperative breeding at the psychological and cognitive level in primates, which bear important implications for our understanding of human cognitive evolution. In the second part, we zoom in on two of these convergent adaptations, proactive prosociality and social learning, and compare their proximate regulation in marmosets and humans with regard to oxytocin and cognitive top down regulation. Our analysis suggests considerable similarity in these regulatory mechanisms presumably because the convergent traits emerged due to small motivational changes that define how pre-existing cognitive mechanisms are quantitatively combined. This finding reconciles the prima facie contradictory rationale for using marmosets as high priority model species in neuroscience and anthropology. Copyright © 2014 Elsevier Ireland Ltd and the Japan Neuroscience Society. All rights reserved.

Involving patients in setting priorities for healthcare improvement: a cluster randomized trial.

PubMed

Boivin, Antoine; Lehoux, Pascale; Lacombe, Réal; Burgers, Jako; Grol, Richard

2014-02-20

Patients are increasingly seen as active partners in healthcare. While patient involvement in individual clinical decisions has been extensively studied, no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population. The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level. Cluster randomized controlled trial. Local communities were randomized in intervention (priority setting with patient involvement) and control sites (no patient involvement). Communities in a canadian region were required to set priorities for improving chronic disease management in primary care, from a list of 37 validated quality indicators. Patients were consulted in writing, before participating in face-to-face deliberation with professionals. Professionals established priorities among themselves, without patient involvement. A total of 172 individuals from six communities participated in the study, including 83 chronic disease patients, and 89 health professionals. The primary outcome was the level of agreement between patients' and professionals' priorities. Secondary outcomes included professionals' intention to use the selected quality indicators, and the costs of patient involvement. Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model, including: access to primary care, self-care support, patient participation in clinical decisions, and partnership with community organizations (p < 0.01). Priorities established by professionals alone placed more emphasis on the technical quality of single disease management. The involvement intervention fostered mutual influence between patients and professionals, which resulted in a 41% increase in agreement on common priorities (95%CI: +12% to +58%, p < 0.01). Professionals' intention to use the selected quality indicators was similar in intervention and control sites. Patient involvement increased the costs of the prioritization process by 17%, and required 10% more time to reach consensus on common priorities. Patient involvement can change priorities driving healthcare improvement at the population level. Future research should test the generalizability of these findings to other contexts, and assess its impact on patient care. The Netherlands National Trial Register #NTR2496.

Involving patients in setting priorities for healthcare improvement: a cluster randomized trial

PubMed Central

2014-01-01

Background Patients are increasingly seen as active partners in healthcare. While patient involvement in individual clinical decisions has been extensively studied, no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population. The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level. Methods Design: Cluster randomized controlled trial. Local communities were randomized in intervention (priority setting with patient involvement) and control sites (no patient involvement). Setting: Communities in a canadian region were required to set priorities for improving chronic disease management in primary care, from a list of 37 validated quality indicators. Intervention: Patients were consulted in writing, before participating in face-to-face deliberation with professionals. Control: Professionals established priorities among themselves, without patient involvement. Participants: A total of 172 individuals from six communities participated in the study, including 83 chronic disease patients, and 89 health professionals. Outcomes: The primary outcome was the level of agreement between patients’ and professionals’ priorities. Secondary outcomes included professionals’ intention to use the selected quality indicators, and the costs of patient involvement. Results Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model, including: access to primary care, self-care support, patient participation in clinical decisions, and partnership with community organizations (p < 0.01). Priorities established by professionals alone placed more emphasis on the technical quality of single disease management. The involvement intervention fostered mutual influence between patients and professionals, which resulted in a 41% increase in agreement on common priorities (95%CI: +12% to +58%, p < 0.01). Professionals’ intention to use the selected quality indicators was similar in intervention and control sites. Patient involvement increased the costs of the prioritization process by 17%, and required 10% more time to reach consensus on common priorities. Conclusions Patient involvement can change priorities driving healthcare improvement at the population level. Future research should test the generalizability of these findings to other contexts, and assess its impact on patient care. Trial registration The Netherlands National Trial Register #NTR2496. PMID:24555508

EPR: Evidence and fallacy.

PubMed

Nichols, Joseph W; Bae, You Han

2014-09-28

The enhanced permeability and retention (EPR) of nanoparticles in tumors has long stood as one of the fundamental principles of cancer drug delivery, holding the promise of safe, simple and effective therapy. By allowing particles preferential access to tumors by virtue of size and longevity in circulation, EPR provided a neat rationale for the trend toward nano-sized drug carriers. Following the discovery of the phenomenon by Maeda in the mid-1980s, this rationale appeared to be well justified by the flood of evidence from preclinical studies and by the clinical success of Doxil. Clinical outcomes from nano-sized drug delivery systems, however, have indicated that EPR is not as reliable as previously thought. Drug carriers generally fail to provide superior efficacy to free drug systems when tested in clinical trials. A closer look reveals that EPR-dependent drug delivery is complicated by high tumor interstitial fluid pressure (IFP), irregular vascular distribution, and poor blood flow inside tumors. Furthermore, the animal tumor models used to study EPR differ from clinical tumors in several key aspects that seem to make EPR more pronounced than in human patients. On the basis of this evidence, we believe that EPR should only be invoked on a case-by-case basis, when clinical evidence suggests the tumor type is susceptible. Copyright © 2014 Elsevier B.V. All rights reserved.

Updated Priorities Among Effective Clinical Preventive Services

PubMed Central

Maciosek, Michael V.; LaFrance, Amy B.; Dehmer, Steven P.; McGree, Dana A.; Flottemesch, Thomas J.; Xu, Zack; Solberg, Leif I.

2017-01-01

PURPOSE The Patient Protection and Affordable Care Act’s provisions for first-dollar coverage of evidence-based preventive services have reduced an important barrier to receipt of preventive care. Safety-net providers, however, still serve a substantial uninsured population, and clinician and patient time remain limited in all primary care settings. As a consequence, decision makers continue to set priorities to help focus their efforts. This report updates estimates of relative health impact and cost-effectiveness for evidence-based preventive services. METHODS We assessed the potential impact of 28 evidence-based clinical preventive services in terms of their cost-effectiveness and clinically preventable burden, as measured by quality-adjusted life years (QALYs) saved. Each service received 1 to 5 points on each of the 2 measures—cost-effectiveness and clinically preventable burden—for a total score ranging from 2 to 10. New microsimulation models were used to provide updated estimates of 12 of these services. Priorities for improving delivery rates were established by comparing the ranking with what is known of current delivery rates nationally. RESULTS The 3 highest-ranking services, each with a total score of 10, are immunizing children, counseling to prevent tobacco initiation among youth, and tobacco-use screening and brief intervention to encourage cessation among adults. Greatest population health improvement could be obtained from increasing utilization of clinical preventive services that address tobacco use, obesity-related behaviors, and alcohol misuse, as well as colorectal cancer screening and influenza vaccinations. CONCLUSIONS This study identifies high-priority preventive services and should help decision makers select which services to emphasize in quality-improvement initiatives. PMID:28376457

Enrollees Choose Priorities for Medicare

ERIC Educational Resources Information Center

Danis, Marion; Biddle, Andrea K.; Goold, Susan Dorr

2004-01-01

Purpose: The purpose of this study was to demonstrate the feasibility and results of ascertaining Medicare enrollees' priorities for insured medical benefits. Design and Methods: Structured group exercises were conducted with Medicare enrollees from clinical and community settings in central North Carolina. By participating in a decision exercise,…

Building confidence in quantitative systems pharmacology models: An engineer's guide to exploring the rationale in model design and development.

PubMed

Timmis, J; Alden, K; Andrews, P; Clark, E; Nellis, A; Naylor, B; Coles, M; Kaye, P

2017-03-01

This tutorial promotes good practice for exploring the rationale of systems pharmacology models. A safety systems engineering inspired notation approach provides much needed rigor and transparency in development and application of models for therapeutic discovery and design of intervention strategies. Structured arguments over a model's development, underpinning biological knowledge, and analyses of model behaviors are constructed to determine the confidence that a model is fit for the purpose for which it will be applied. © 2016 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Assessing the Rationale and Effectiveness of Frozen Plasma Transfusions: An Evidence-based Review.

PubMed

Tinmouth, Alan

2016-06-01

Frozen plasma is a commonly used blood product. The primary indications for frozen plasma are the treatment and prevention of bleeding in patients with prolonged coagulation tests. However, there is a lack of well-conducted clinical trials to determine the appropriate indications for frozen plasma. The rationale and evidence for frozen plasma transfusions are reviewed, including the evidence or lack of evidence supporting common indications. Targeting indications in which frozen plasma transfusions are clearly not beneficial as supported by the current evidence provides an opportunity to improve the current use of frozen plasma and reduce adverse transfusion events. Copyright © 2016 Elsevier Inc. All rights reserved.

Priority service needs and receipt across the lifespan for individuals with autism spectrum disorder

PubMed Central

Lai, Jonathan K. Y.

2017-01-01

Abstract Individuals with Autism Spectrum Disorder (ASD) have a range of health, community, and social support needs across the lifespan that create age‐specific challenges in navigating service sectors. In this study, we set out to identify the priority needs of individuals with ASD across the lifespan, and the factors that predict receiving priority services. Participants included 3,317 individuals with ASD from a Canada‐wide online caregiver survey, stratified into five age groups (preschool, elementary school age, adolescence, emerging adulthood, adulthood). Priority receipt was calculated as a ratio of current services that corresponded to individualized priority need. Age‐stratified Poisson regression analyses were used to identify the sociodemographic, clinical and systemic predictors of priority receipt. Results indicate that the distribution of priority need varied by age, except for social skills programming, which was a high across all groups. The number of high and moderate priority needs diversified with age. Overall, 30% of individuals had none of their priority needs met and priority receipt decreased with age. Systemic factors were most consistently related to priority receipt across the lifespan. Understanding patterns and correlates of priority needs and use that currently exist in different age groups can inform policies to improve service access. Autism Res 2017, 10: 1436–1447. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. PMID:28383156

Extending the Reach of Evidence-Based Medicine: A Proposed Categorization of Lower-Level Evidence.

PubMed

Detterbeck, Frank C; Gould, Michael K; Lewis, Sandra Zelman; Patel, Sheena

2018-02-01

Clinical practice involves making many treatment decisions for which only limited formal evidence exists. While the methodology of evidence-based medicine (EBM) has evolved tremendously, there is a need to better characterize lower-level evidence. This should enhance the ability to appropriately weigh the evidence against other considerations, and counter the temptation to think it is more robust than it actually is. A framework to categorize lower-level evidence is proposed, consisting of nonrandomized comparisons, extrapolation using indirect evidence, rationale, and clinical experience (ie, an accumulated general impression). Subtypes are recognized within these categories, based on the degree of confounding in nonrandomized comparisons, the uncertainty involved in extrapolation from indirect evidence, and the plausibility of a rationale. Categorizing the available evidence in this way can promote a better understanding of the strengths and limitations of using such evidence as the basis for treatment decisions in clinically relevant areas that are devoid of higher-level evidence. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Non-operative management of posterior tibialis tendon dysfunction: design of a randomized clinical trial [NCT00279630

PubMed Central

Kulig, Kornelia; Pomrantz, Amy B; Burnfield, Judith M; Reischl, Stephen F; Mais-Requejo, Susan; Thordarson, David B; Smith, Ronald W

2006-01-01

Background Posterior tibialis tendon dysfunction (PTTD) is a common cause of foot pain and dysfunction in adults. Clinical observations strongly suggest that the condition is progressive. There are currently no controlled studies evaluating the effectiveness of exercise, orthoses, or orthoses and exercise on Stage I or IIA PTTD. Our study will explore the effectiveness of an eccentric versus concentric strengthening intervention to results obtained with the use of orthoses alone. Findings from this study will guide the development of more efficacious PTTD intervention programs and contribute to enhanced function and quality of life in persons with posterior tibialis tendon dysfunction. Methods/design This paper presents the rationale and design for a randomized clinical trial evaluating the effectiveness of a treatment regime for the non-operative management of Stage I or IIA PTTD. Discussion We have presented the rationale and design for an RCT evaluating the effectiveness of a treatment regimen for the non-operative management of Stage I or IIA PTTD. The results of this trial will be presented as soon as they are available. PMID:16756656

Thrombosis in Cancer: Research Priorities Identified by a National Cancer Institute/National Heart, Lung, and Blood Institute Strategic Working Group.

PubMed

Key, Nigel S; Khorana, Alok A; Mackman, Nigel; McCarty, Owen J T; White, Gilbert C; Francis, Charles W; McCrae, Keith R; Palumbo, Joseph S; Raskob, Gary E; Chan, Andrew T; Sood, Anil K

2016-07-01

The risk for venous thromboembolism (VTE) is increased in cancer and particularly with chemotherapy, and it portends poorer survival among patients with cancer. However, many fundamental questions about cancer-associated VTE, or Trousseau syndrome, remain unanswered. This report summarizes the proceedings of a working group assembled by the NCI and NHLBI in August 2014 to explore the state of the science in cancer-associated VTE, identify clinically important research gaps, and develop consensus on priorities for future research. Representing a convergence of research priorities between the two NIH Institutes, the workshop addressed epidemiologic, basic science, clinical, and translational issues in cancer-associated VTE. Cancer Res; 76(13); 3671-5. ©2016 AACR. ©2016 American Association for Cancer Research.

Three case definitions of malaria and their effect on diagnosis, treatment and surveillance in Cox's Bazar district, Bangladesh.

PubMed

Montanari, R M; Bangali, A M; Talukder, K R; Baqui, A; Maheswary, N P; Gosh, A; Rahman, M; Mahmood, A H

2001-01-01

In countries where malaria is endemic, routine blood slide examinations remain the major source of data for the public health surveillance system. This approach has become inadequate, however, as the public health emphasis has changed from surveillance of laboratory-confirmed malaria infections to the early detection and treatment of the disease. As a result, it has been advocated that the information collected about malaria be changed radically and should include the monitoring of morbidity and mortality, clinical practice and quality of care. To improve the early diagnosis and prompt treatment (EDPT) of malaria patients, three malaria case definitions (MCDs) were developed, with treatment and reporting guidelines, and used in all static health facilities of Cox's Bazar district, Bangladesh (population 1.5 million). The three MCDs were: uncomplicated malaria (UM); treatment failure malaria (TFM); and severe malaria (SM). The number of malaria deaths was also reported. This paper reviews the rationale and need for MCDs in malaria control programmes and presents an analysis of the integrated surveillance information collected during the three-year period, 1995-97. The combined analysis of slide-based and clinical data and their related indicators shows that blood slide analysis is no longer used to document fever episodes but to support EDPT, with priority given to SM and TFM patients. Data indicate a decrease in the overall positive predictive value of the three MCDs as malaria prevalence decreases. Hence the data quantify the extent to which the mainly clinical diagnosis of UM leads to over-diagnosis and over-treatment in changing epidemiological conditions. Also the new surveillance data show: a halving in the case fatality rate among SM cases (from 6% to 3.1%) attributable to improved quality of care, and a stable proportion of TFM cases (around 7%) against a defined population denominator. Changes implemented in the EDPT of malaria patients and in the surveillance system were based on existing staff capacity and routine reporting structures.

An international eDelphi study identifying the research and education priorities in wound management and tissue repair.

PubMed

Cowman, Seamus; Gethin, Georgina; Clarke, Eric; Moore, Zena; Craig, Gerardine; Jordan-O'Brien, Julie; McLain, Niamh; Strapp, Helen

2012-02-01

To incorporate an international and multidisciplinary consensus in the determination of the research and education priorities for wound healing and tissue repair. A compelling reason for the study is the lack of an agreed list of priorities for wound care research and education. Furthermore, there is a growth in the prevalence of chronic wounds, a growth in wound care products and marketing, and an increase in clinician attendance at conferences and education programmes. The study used a survey method. A four-round eDelphi technique was used to collect responses from an international population of health professionals across 24 countries. Responses were obtained from 360 professionals representing many health care settings. The top education priorities related to the standardisation of all foundation education programmes in wound care, the inclusion of wound care in all professional undergraduate and postgraduate education programmes, selecting dressings and the prevention of pressure ulcers. The top research priorities related to the dressing selection, pressure ulcer prevention and wound infection. conclusion: Professionals from different backgrounds and countries who are engaged in wound management share a common set of priorities for research and education. Most notably, the priorities identified relate to long-established clinical challenges in wound care and underpin the principles of good patient care practices. The priorities are closely allied to an ageing population and identify many challenges ahead for practitioners engaged in wound management services. The provision of wound care is a major investment of health service resources and remains a clinical challenge today. Research is essential to building evidence-based practice and fundamental to development of quality in standards of practice; education is central to achieving competence to deliver effective care. The determination of research and education priorities is therefore an absolute requirement in developing services. © 2011 Blackwell Publishing Ltd.

A comprehensive program for children with gender variant behaviors and gender identity disorders.

PubMed

Menvielle, Edgardo

2012-01-01

This article describes a clinical program designed to address broadly defined mental health needs of children who experience stress related to not fitting into normative gender types and argues for the need for integrated services that address the spectrum of gender variance. An array of services useful to children and their families is proposed. The article describes the clinical population served, common clinical and social problems, and a rationale for the interventions provided.

The pharmacological rationale for combining muscarinic receptor antagonists and β-adrenoceptor agonists in the treatment of airway and bladder disease☆

PubMed Central

Dale, Philippa R; Cernecka, Hana; Schmidt, Martina; Dowling, Mark R; Charlton, Steven J; Pieper, Michael P; Michel, Martin C

2014-01-01

Muscarinic receptor antagonists and β-adrenoceptor agonists are used in the treatment of obstructive airway disease and overactive bladder syndrome. Here we review the pharmacological rationale for their combination. Muscarinic receptors and β-adrenoceptors are physiological antagonists for smooth muscle tone in airways and bladder. Muscarinic agonism may attenuate β-adrenoceptor-mediated relaxation more than other contractile stimuli. Chronic treatment with one drug class may regulate expression of the target receptor but also that of the opposing receptor. Prejunctional β2-adrenoceptors can enhance neuronal acetylcholine release. Moreover, at least in the airways, muscarinic receptors and β-adrenoceptors are expressed in different locations, indicating that only a combined modulation of both systems may cause dilatation along the entire bronchial tree. While all of these factors contribute to a rationale for a combination of muscarinic receptor antagonists and β-adrenoceptor agonists, the full value of such combination as compared to monotherapy can only be determined in clinical studies. PMID:24682092

High-level intuitive features (HLIFs) for intuitive skin lesion description.

PubMed

Amelard, Robert; Glaister, Jeffrey; Wong, Alexander; Clausi, David A

2015-03-01

A set of high-level intuitive features (HLIFs) is proposed to quantitatively describe melanoma in standard camera images. Melanoma is the deadliest form of skin cancer. With rising incidence rates and subjectivity in current clinical detection methods, there is a need for melanoma decision support systems. Feature extraction is a critical step in melanoma decision support systems. Existing feature sets for analyzing standard camera images are comprised of low-level features, which exist in high-dimensional feature spaces and limit the system's ability to convey intuitive diagnostic rationale. The proposed HLIFs were designed to model the ABCD criteria commonly used by dermatologists such that each HLIF represents a human-observable characteristic. As such, intuitive diagnostic rationale can be conveyed to the user. Experimental results show that concatenating the proposed HLIFs with a full low-level feature set increased classification accuracy, and that HLIFs were able to separate the data better than low-level features with statistical significance. An example of a graphical interface for providing intuitive rationale is given.

Parent Refusal of Topical Fluoride for Their Children: Clinical Strategies and Future Research Priorities to Improve Evidence-Based Pediatric Dental Practice.

PubMed

Chi, Donald L

2017-07-01

A growing number of parents are refusing topical fluoride for their children during preventive dental and medical visits. This nascent clinical and public health problem warrants attention from dental professionals and the scientific community. Clinical and community-based strategies are available to improve fluoride-related communications with parents and the public. In terms of future research priorities, there is a need to develop screening tools to identify parents who are likely to refuse topical fluoride and diagnostic instruments to uncover the reasons for topical fluoride refusal. This knowledge will lead to evidence-based strategies that can be widely disseminated into clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

Use of health information technology by children's hospitals in the United States.

PubMed

Menachemi, Nir; Brooks, Robert G; Schwalenstocker, Ellen; Simpson, Lisa

2009-01-01

The purpose of this study was to examine the adoption of health information technology by children's hospitals and to document barriers and priorities as they relate to health information technology adoption. Primary data of interest were obtained through the use of a survey instrument distributed to the chief information officers of 199 children's hospitals in the United States. Data were collected on current and future use of a variety of clinical health information technology and telemedicine applications, organizational priorities, barriers to use of health information technology, and hospital and chief information officer characteristics. Among the 109 responding hospitals (55%), common clinical applications included clinical scheduling (86.2%), transcription (85.3%), and pharmacy (81.9%) and laboratory (80.7%) information. Electronic health records (48.6%), computerized order entry (40.4%), and clinical decision support systems (35.8%) were less common. The most common barriers to health information technology adoption were vendors' inability to deliver products or services to satisfaction (85.4%), lack of staffing resources (82.3%), and difficulty in achieving end-user acceptance (80.2%). The most frequent priority for hospitals was to implement technology to reduce medical errors or to promote safety (72.5%). This first national look at health information technology use by children's hospitals demonstrates the progress in health information technology adoption, current barriers, and priorities for these institutions. In addition, the findings can serve as important benchmarks for future study in this area.

Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit.

PubMed

Bonfant, Giovanna; Belfanti, Pietro; Paternoster, Giuseppe; Gabrielli, Danila; Gaiter, Alberto M; Manes, Massimo; Molino, Andrea; Pellu, Valentina; Ponzetti, Clemente; Farina, Massimo; Nebiolo, Pier E

2010-01-01

The aim of clinical risk management is to improve the quality of care provided by health care organizations and to assure patients' safety. Failure mode and effect analysis (FMEA) is a tool employed for clinical risk reduction. We applied FMEA to chronic hemodialysis outpatients. FMEA steps: (i) process study: we recorded phases and activities. (ii) Hazard analysis: we listed activity-related failure modes and their effects; described control measures; assigned severity, occurrence and detection scores for each failure mode and calculated the risk priority numbers (RPNs) by multiplying the 3 scores. Total RPN is calculated by adding single failure mode RPN. (iii) Planning: we performed a RPNs prioritization on a priority matrix taking into account the 3 scores, and we analyzed failure modes causes, made recommendations and planned new control measures. (iv) Monitoring: after failure mode elimination or reduction, we compared the resulting RPN with the previous one. Our failure modes with the highest RPN came from communication and organization problems. Two tools have been created to ameliorate information flow: "dialysis agenda" software and nursing datasheets. We scheduled nephrological examinations, and we changed both medical and nursing organization. Total RPN value decreased from 892 to 815 (8.6%) after reorganization. Employing FMEA, we worked on a few critical activities, and we reduced patients' clinical risk. A priority matrix also takes into account the weight of the control measures: we believe this evaluation is quick, because of simple priority selection, and that it decreases action times.

Integrating gene expression data with demographic, clinical, and environmental exposure information to reveal endotypes of childhood asthma

EPA Science Inventory

RATIONALE. Childhood asthma is a multifactorial disease whose pathogenesis involves complex interplay between genetic susceptibility and modulating external factors. Therefore, effectively characterizing these multiple etiological pathways, or “endotypes”, requires an integrative...

Coronary diet intervention with olive oil and cardiovascular prevention study (the CORDIOPREV study); rationale, methods, and baseline characteristics: a clinical trial comparing the efficacy of a Mediterranean diet rich...

USDA-ARS?s Scientific Manuscript database

Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secon...

Types of Programs and Evaluation Processes Needed to Maximize the Pharmacist's Contribution to Society: 2--The Role of the Clinical Sciences.

ERIC Educational Resources Information Center

Gans, John A.; Downs, George E.

1978-01-01

The role of clinical sciences in the continuing education of pharmacists is seen to be primarily in the area of changing the practice of pharmacy. Programs are described that would alter pharmacists' practice setting, namely the services they provide, and thus establish a rationale for pharmacists' need for continuing education. (JMD)

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

PubMed

Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

2017-10-01

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study purpose, 7 accurately and 4 inaccurately compared with the reference standard. Seventy-one of 72 noninferiority trial protocols or SAPs provided no rationale for selection of noninferiority hypothesis. None provided a clinical rationale for the chosen amount of decreased efficacy. Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.

A research agenda for gastrointestinal and endoscopic surgery.

PubMed

Urbach, D R; Horvath, K D; Baxter, N N; Jobe, B A; Madan, A K; Pryor, A D; Khaitan, L; Torquati, A; Brower, S T; Trus, T L; Schwaitzberg, S

2007-09-01

Development of a research agenda may help to inform researchers and research-granting agencies about the key research gaps in an area of research and clinical care. The authors sought to develop a list of research questions for which further research was likely to have a major impact on clinical care in the area of gastrointestinal and endoscopic surgery. A formal group process was used to conduct an iterative, anonymous Web-based survey of an expert panel including the general membership of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). In round 1, research questions were solicited, which were categorized, collapsed, and rewritten in a common format. In round 2, the expert panel rated all the questions using a priority scale ranging from 1 (lowest) to 5 (highest). In round 3, the panel re-rated the 40 questions with the highest mean priority score in round 2. A total of 241 respondents to round 1 submitted 382 questions, which were reduced by a review panel to 106 unique questions encompassing 33 topics in gastrointestinal and endoscopic surgery. In the two successive rounds, respectively, 397 and 385 respondents ranked the questions by priority, then re-ranked the 40 questions with the highest mean priority score. High-priority questions related to antireflux surgery, the oncologic and immune effects of minimally invasive surgery, and morbid obesity. The question with the highest mean priority ranking was: "What is the best treatment (antireflux surgery, endoluminal therapy, or medication) for GERD?" The second highest-ranked question was: "Does minimally invasive surgery improve oncologic outcomes as compared with open surgery?" Other questions covered a broad range of research areas including clinical research, basic science research, education and evaluation, outcomes measurement, and health technology assessment. An iterative, anonymous group survey process was used to develop a research agenda for gastrointestinal and endoscopic surgery consisting of the 40 most important research questions in the field. This research agenda can be used by researchers and research-granting agencies to focus research activity in the areas most likely to have an impact on clinical care, and to appraise the relevance of scientific contributions.

Setting priorities for comparative effectiveness research on management of primary angle closure: a survey of Asia-Pacific clinicians.

PubMed

Yu, Tsung; Li, Tianjing; Lee, Kinbo J; Friedman, David S; Dickersin, Kay; Puhan, Milo A

2015-01-01

To set priorities for new systematic reviews (SRs) and randomized clinical trials on the management of primary angle closure (PAC) using clinical practice guidelines and a survey of Asia-Pacific clinicians. We restated the American Academy of Ophthalmology's Preferred Practice Patterns recommendations for management of PAC into answerable clinical questions. We asked participants at the Asia-Pacific Joint Glaucoma Congress 2010 in Taipei to rate the importance of having an answer to each question for providing effective patient care, using a Likert-type scale and scoring from 0 (not important at all) to 10 (highly important). We identified relevant SRs and mapped the evidence to clinical questions to identify evidence gaps. We generated 42 clinical questions. One hundred seventy-five individuals agreed to participate in the survey, 132 responded (75.4% response rate) and 96 completed the questionnaire (54.9% usable response rate). Questions rated important include laser iridotomy for the prevention of angle closure in primary angle-closure suspects, further therapies in eyes with plateau iris syndrome after laser iridotomy, and evaluation of the fellow eye in acute angle-closure patients for improving prognosis. Up-to-date and conclusive SR evidence was not available for any of the 42 clinical questions. We identified high priority clinical questions on the management of PAC, none of which had reliable SR evidence available. New SRs and randomized clinical trials can be initiated to address these evidence gaps.

Chairmanship of the Neptune/Pluto outer planets science working group

NASA Astrophysics Data System (ADS)

Stern, S. Alan

1993-11-01

The Outer Planets Science Working Group (OPSWG) is the NASA Solar System Exploration Division (SSED) scientific steering committee for the Outer Solar System missions. OPSWG consists of 19 members and is chaired by Dr. S. Alan Stern. This proposal summarizes the FY93 activities of OPSWG, describes a set of objectives for OPSWG in FY94, and outlines the SWG's activities for FY95. As chair of OPSWG, Dr. Stern will be responsible for: organizing priorities, setting agendas, conducting meetings of the Outer Planets SWG; reporting the results of OPSWG's work to SSED; supporting those activities relating to OPSWG work, such as briefings to the SSES, COMPLEX, and OSS; supporting the JPL/SAIC Pluto study team; and other tasks requested by SSED. As the Scientific Working Group (SWG) for Jupiter and the planets beyond, OPSWG is the SSED SWG chartered to study and develop mission plans for all missions to the giant planets, Pluto, and other distant objects in the remote outer solar system. In that role, OPSWG is responsible for: defining and prioritizing scientific objectives for missions to these bodies; defining and documenting the scientific goals and rationale behind such missions; defining and prioritizing the datasets to be obtained in these missions; defining and prioritizing measurement objectives for these missions; defining and documenting the scientific rationale for strawman instrument payloads; defining and prioritizing the scientific requirements for orbital tour and flyby encounter trajectories; defining cruise science opportunities plan; providing technical feedback to JPL and SSED on the scientific capabilities of engineering studies for these missions; providing documentation to SSED concerning the scientific goals, objectives, and rationale for the mission; interfacing with other SSED and OSS committees at the request of SSED's Director or those committee chairs; providing input to SSED concerning the structure and content of the Announcement of Opportunity for payload and scientific team selection for such missions; and providing other technical or programmatic inputs concerning outer solar system missions at the request of the Director of SSED.

Chairmanship of the Neptune/Pluto outer planets science working group

NASA Technical Reports Server (NTRS)

Stern, S. Alan

1993-01-01

The Outer Planets Science Working Group (OPSWG) is the NASA Solar System Exploration Division (SSED) scientific steering committee for the Outer Solar System missions. OPSWG consists of 19 members and is chaired by Dr. S. Alan Stern. This proposal summarizes the FY93 activities of OPSWG, describes a set of objectives for OPSWG in FY94, and outlines the SWG's activities for FY95. As chair of OPSWG, Dr. Stern will be responsible for: organizing priorities, setting agendas, conducting meetings of the Outer Planets SWG; reporting the results of OPSWG's work to SSED; supporting those activities relating to OPSWG work, such as briefings to the SSES, COMPLEX, and OSS; supporting the JPL/SAIC Pluto study team; and other tasks requested by SSED. As the Scientific Working Group (SWG) for Jupiter and the planets beyond, OPSWG is the SSED SWG chartered to study and develop mission plans for all missions to the giant planets, Pluto, and other distant objects in the remote outer solar system. In that role, OPSWG is responsible for: defining and prioritizing scientific objectives for missions to these bodies; defining and documenting the scientific goals and rationale behind such missions; defining and prioritizing the datasets to be obtained in these missions; defining and prioritizing measurement objectives for these missions; defining and documenting the scientific rationale for strawman instrument payloads; defining and prioritizing the scientific requirements for orbital tour and flyby encounter trajectories; defining cruise science opportunities plan; providing technical feedback to JPL and SSED on the scientific capabilities of engineering studies for these missions; providing documentation to SSED concerning the scientific goals, objectives, and rationale for the mission; interfacing with other SSED and OSS committees at the request of SSED's Director or those committee chairs; providing input to SSED concerning the structure and content of the Announcement of Opportunity for payload and scientific team selection for such missions; and providing other technical or programmatic inputs concerning outer solar system missions at the request of the Director of SSED.

Summary of the Report of the U.S. National Research Council's Committee on Human Spaceflight

NASA Astrophysics Data System (ADS)

Moloney, Michael; Graham, Sandra; Angleman, Alan

Human spaceflight is considered by many to be the ultimate human endeavor in space—a pursuit to determine just how far human beings can venture into the cosmos and to understand what it is we will find and what we can do as a species in space. The U.S. National Research Council’s Committee on Human Spaceflight was charged to examine carefully and thoroughly the rationale for and value of human spaceflight in as broad a context as possible. Whereas the financial benefit of the peaceful uses of outer space, such as using space-based assets for communication systems or weather prediction, might be clear and the scientific benefits of the robotic exploration of our cosmos might be compelling, understanding the extent to which the world needs or desires human spaceflight requires a much more nuanced and complex assessment. This paper will focus on this committee’s assessment of these questions and describe the findings and recommendations of the committee’s report—in particular, examining the long-term goals and direction of a sustainable future for human spaceflight. The report, which will be released in Spring 2014, examines the rationales and benefits of human spaceflight—in the context the needs of science, industry, international relations and partnerships, and the public good—and a sustainable pathway approach to human deep space exploration. The talk would present the committee's understanding of the rationales, pathways, and decision rules that could enable and guide future planning of human space exploration. This US-NRC study was requested by the U.S. Congress and supported by the National Aeronautics and Space Administration (NASA). Conducted over 18 months, a committee of experts, drawn from diverse areas of expertise spanning the National Academies system, the study: • Considered the goals for human spaceflight and the expected value of NASA’s human spaceflight activities in the context of national goals, • Solicited broadly-based, but directed, public and stakeholder input to understand better the motivations, goals, and possible evolution of human spaceflight, • Considered how to identify a set of high-priority enduring questions that could provide the rationale for and value of human exploration in a national and international context, and • Reviewed prior national and international studies and reports on human spaceflight.

Priorities for clinical research in intracerebral hemorrhage: report from a National Institute of Neurological Disorders and Stroke workshop.

PubMed

2005-03-01

Spontaneous intracerebral hemorrhage (ICH) is one of the most lethal stroke types. In December 2003, a National Institute of Neurological Disorders and Stroke (NINDS) workshop was convened to develop a consensus for ICH research priorities. The focus was clinical research aimed at acute ICH in patients. Workshop participants were divided into 6 groups: (1) current state of ICH research; (2) basic science; and (3) imaging, (4) medical, (5) surgical, and (6) clinical methodology. Each group formulated research priorities before the workshop. At the workshop, these were discussed and refined. Recent progress in management of hemorrhage growth, intraventricular hemorrhage, and limitations in the benefit of open craniotomy were noted. The workshop identified the importance of developing animal models to reflect human ICH, as well as the phenomena of rebleeding. More human ICH pathology is needed. Real-time, high-field magnets and 3-dimensional imaging, as well as high-resolution tissue probes, are ICH imaging priorities. Trials of acute blood pressure-lowering in ICH and coagulopathy reversal are medical priorities. The exact role of edema in human ICH pathology and its treatment requires intensive study. Trials of minimally invasive surgical techniques including mechanical and chemical surgical adjuncts are critically important. The methodologic challenges include establishing research networks and a multi-specialty approach. Waiver of consent issues and standardizing care in trials are important issues. Encouragement of young investigators from varied backgrounds to enter the ICH research field is critical. Increasing ICH research is crucial. A collaborative approach is likely to yield therapies for this devastating form of brain injury.

Research priorities for specialized nursing practice in the United Arab Emirates.

PubMed

Al-Yateem, N; Al-Tamimi, M; Brenner, M; Altawil, H; Ahmad, A; Brownie, S

2017-08-25

Globally, nurses are undertaking expanded and more specialized roles in healthcare planning and service delivery in response to changing patterns and levels of health service demand. This means the nursing profession is increasingly considered as leaders in health service policy, research and practice. The United Arab Emirates has strengthened nursing governance and practice by establishing a Nursing and Midwifery Council and increasing the activity of nursing specialization, service leadership and research. This study aimed to identify clinically relevant research priorities to facilitate nursing contributions to evidence-based care and strengthening health services in the country. A two-stage Delphi study design was used. The first round involved 783 participants. The second round involved 1116 participants, as more clinical settings were accessed. In total, 58 research priorities across a variety of nursing specialties (paediatrics, emergency care, intensive care, labour and maternity care, operating theatre and long-term care) were identified as highly important. These identified priorities will guide a more informed programme of research in each nursing specialty, with the aim of strengthening the evidence base to improving outcomes for patients and their families in the United Arab Emirates. The findings provide guidance on key areas for nurses to focus research contributions to enhance evidence-based care and strengthen health systems. The identified priorities may also guide researchers in academic institutions to conduct research informed by current, clinically relevant issues. The findings may help inform funders and policymakers to support allocation of funding to research that has potential to contribute to enhancing nursing care in specialist areas. © 2017 International Council of Nurses.

Addressing health and health-care disparities: the role of a diverse workforce and the social determinants of health.

PubMed

Jackson, Chazeman S; Gracia, J Nadine

2014-01-01

Despite major advances in medicine and public health during the past few decades, disparities in health and health care persist. Racial/ethnic minority groups in the United States are at disproportionate risk of being uninsured, lacking access to care, and experiencing worse health outcomes from preventable and treatable conditions. As reducing these disparities has become a national priority, insight into the social determinants of health has become increasingly important. This article offers a rationale for increasing the diversity and cultural competency of the health and health-care workforce, and describes key strategies led by the U.S. Department of Health and Human Services' Office of Minority Health to promote cultural competency in the health-care system and strengthen community-level approaches to improving health and health care for all.

Tailoring Water, Sanitation, and Hygiene (WASH) Targets for Soil-Transmitted Helminthiasis and Schistosomiasis Control.

PubMed

Campbell, Suzy J; Biritwum, Nana-Kwadwo; Woods, Geordie; Velleman, Yael; Fleming, Fiona; Stothard, J Russell

2018-01-01

The World Health Organization's (WHO) 2015-2020 Global Strategy on water, sanitation, and hygiene (WASH) and neglected tropical diseases (NTDs) encourages integration, whilst maintaining existing structured NTD investments, and acceleration towards Sustainable Development Goal (SDG) targets. Accordingly, SDG-associated and WASH-NTD indicators have been developed, commencing important intersectoral dialogue, alongside opportunities for future disease-specific refinements. The rationale for soil-transmitted helminthiasis (STH)- and schistosomiasis-specific WASH considerations, and a traffic-light figure, are presented here to indicate where current international definitions may, or may not, suffice. Certain unique aspects in control dynamics and parasitic lifecycles, however, necessitate additional implementation research with more appropriate measurement indicators developed to record programmatic interventions and to define strategic priorities more effectively. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Vision Forward for NASA's Astrophysics Education Program

NASA Astrophysics Data System (ADS)

Hasan, Hashima; Sheth, Kartik J.

2016-01-01

NASA has recently re-structured its Science Education program with the competitive selection of twenty-seven programs. Of these, ~60% are relevant to Astrophysics, and three have primarily Astrophysics content. A brief overview of the rationale for re-structuring will be presented. We have taken a strategic approach, building on our science-discipline based legacy and looking at new approaches given Stakeholder priorities. We plan to achieve our education goals with the selection of organizations that utilize NASA data, products, or processes to meet NASA's education objectives; and by enabling our scientists and engineers with education professionals, tools, and processes to better meet user needs. Highlights of the selected programs will be presented, and how they enable the vision going forward of achieving the goal of enabling NASA scientists and engineers to engage more effectively with learners of all ages.

Interdependencies and Risks at the Nexus of Energy, Water, and Land Systems

NASA Astrophysics Data System (ADS)

Geernaert, G. L.

2016-12-01

During recent years, the federal agencies have rallied around efforts to understand and predict the interdependencies involving various combinations of energy infrastructure and supply, water supply and quality, and land use that combines agriculture and food production. The US Department of Energy has, in particular, focused on the energy-water nexus, with specific goals to understand the degree of interdependence that leads to multi-sector risk and, in the worst case, the precursors that can lead to cascading failure. Determining thresholds for system interdependence, evaluating the impact of drought on systems, and planning for robust mitigation options to avert future risks, are among DOE's highest research priorities. In this presentation, the DOE program plan and its rationale will be described; and the DOE plan will be placed in context of broader efforts across the federal government.

Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee

PubMed Central

Paller, Channing J.; Bradbury, Penelope A.; Ivy, S. Percy; Seymour, Lesley; LoRusso, Patricia M.; Baker, Laurence; Rubinstein, Larry; Huang, Erich; Collyar, Deborah; Groshen, Susan; Reeves, Steven; Ellis, Lee M.; Sargent, Daniel J.; Rosner, Gary L.; LeBlanc, Michael L.; Ratain, Mark J.

2014-01-01

Anticancer drugs are combined in an effort to treat a heterogeneous tumor or to maximize the pharmacodynamic effect. The development of combination regimens, while desirable, poses unique challenges. These include the selection of agents for combination therapy that may lead to improved efficacy while maintaining acceptable toxicity, the design of clinical trials that provide informative results for individual agents and combinations, and logistical and regulatory challenges. The phase 1 trial is often the initial step in the clinical evaluation of a combination regimen. In view of the importance of combination regimens and the challenges associated with developing them, the Clinical Trial Design (CTD) Task Force of the National Cancer Institute (NCI) Investigational Drug Steering Committee developed a set of recommendations for the phase 1 development of a combination regimen. The first two recommendations focus on the scientific rationale and development plans for the combination regimen; subsequent recommendations encompass clinical design aspects. The CTD Task Force recommends that selection of the proposed regimens be based on a biological or pharmacological rationale supported by clinical and/or robust and validated preclinical evidence, and accompanied by a plan for subsequent development of the combination. The design of the phase 1 clinical trial should take into consideration the potential pharmacokinetic and pharmacodynamic interactions as well as overlapping toxicity. Depending on the specific hypothesized interaction, the primary endpoint may be dose optimization, pharmacokinetics, and/or pharmacodynamic (i.e., biomarker). PMID:25125258

Speech and language therapists' approaches to communication intervention with children and adults with profound and multiple learning disability.

PubMed

Goldbart, Juliet; Chadwick, Darren; Buell, Susan

2014-11-01

People with profound intellectual and multiple disabilities (PMLD) have communication impairments as one defining characteristic. To explore speech and language therapists' (SLTs) decision making in communication interventions for people with PMLD, in terms of the intervention approaches used, the factors informing the decisions to use specific interventions and the extent to which the rationales underpinning these decisions related to the components of evidence based practice (EBP), namely empirical evidence, clinical experience and client/carer views and values. A questionnaire on communication assessment and intervention for people with PMLD was sent to SLTs in the UK to elicit information on: the communication intervention approaches they used; their rationales for their intervention choices; their use of published evidence to inform decision making. Intensive interaction and objects of reference were the communication interventions most often used with people with PMLD, with some differences between children and adults evident. Rationales provided conformed somewhat to the EBP framework though extension of the existing framework and addition of practical and organizational considerations led to a revised typology of rationale for decision making. Rationales most frequently related to the empowerment, development and behavioural preferences of the person with PMLD. Empirical research evidence was seldom mentioned by SLTs as informing intervention decision making leading to very diverse practice. There is a need for further research on the effectiveness of commonly used but under-evaluated interventions. There is also a need to alert SLTs to the evidence base supporting other approaches, particularly switch-based, cause and effect approaches. © 2014 Royal College of Speech and Language Therapists.

Antibacterial resistance leadership group: open for business.

PubMed

Chambers, Henry F; Bartlett, John G; Bonomo, Robert A; Chiou, Christine; Cosgrove, Sara E; Cross, Heather R; Daum, Robert S; Downing, Michele; Evans, Scott R; Knisely, Jane; Kreiswirth, Barry N; Lautenbach, Ebbing; Mickley, Brenda S; Patel, Robin; Pettigrew, Melinda M; Rodvold, Keith A; Spellberg, Brad; Fowler, Vance G

2014-06-01

Funded by the National Institute of Allergy and Infectious Diseases, the Antibacterial Resistance Leadership Group (ARLG) is tasked with developing a clinical research agenda and conducting clinical studies to address the growing public health threat of antibacterial resistance. The ARLG has identified 4 high-priority areas of research: infections caused by gram-negative bacteria, infections caused by gram-positive bacteria, antimicrobial stewardship and infection prevention, and diagnostics. The ARLG will be accepting proposals from the scientific community for clinical research that addresses 1 or more of these high-priority areas. These studies should have the potential to transform medical practice and be unlikely to occur without ARLG support. The purpose of this article is to make interested parties aware of clinical research opportunities made available by ARLG and to encourage submission of clinical research proposals that address the problem of antibacterial resistance.

The oxidized low-density lipoprotein receptor mediates vascular effects of inhaled vehicle emissions

EPA Science Inventory

Rationale: To determine vascular signaling pathways involved in air pollution (vehicular engine emission) exposure -induced exacerbation of atherosclerosis, associated with onset of clinical cardiovascular events. Objective: To elucidate the role of oxidized LDL (oxLDL) and its ...

Drugs in Mental Retardation: Treatment or Tragedy?

ERIC Educational Resources Information Center

Aman, Michael G.

1985-01-01

Treatment of mentally retarded persons with psychotropic and anticonvulsant drugs is discussed in terms of drug classification, rationale for use, attitudes toward use, and clinical research findings. The literature on neuroleptic, anticonvulsant, anxiolytic, and cerebral stimulant drugs is summarized. Controversial reports that some medications…

Fish oil and olive oil-rich diets modify ozone-induced cardiovascular effect in rats

EPA Science Inventory

Rationale: Air pollution exposure has been associated with adverse cardiovascular health effects. Our clinical studies suggest that fish oil (FO) and olive oil (OO) supplementations attenuate the cardiovascular responses to inhaled concentrated ambient particles. This study was...

Brain SPECT Imaging in Complex Psychiatric Cases: An Evidence-Based, Underutilized Tool

PubMed Central

Amen, Daniel G; Trujillo, Manuel; Newberg, Andrew; Willeumier, Kristen; Tarzwell, Robert; Wu, Joseph C; Chaitin, Barry

2011-01-01

Over the past 20 years brain Single Photon Emission Computed Tomography (SPECT) imaging has developed a substantial, evidence-based foundation and is now recommended by professional societies for numerous indications relevant to psychiatric practice. Unfortunately, SPECT in clinical practice is utilized by only a handful of clinicians. This article presents a rationale for a more widespread use of SPECT in clinical practice for complex cases, and includes seven clinical applications where it may help optimize patient care. PMID:21863144

UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications, and Consent

PubMed Central

Horst, Jeremy A; Ellenikiotis, Hellene; Milgrom, Peter M

2016-01-01

The Food and Drug Administration recently cleared silver diamine fluoride for reducing tooth sensitivity. Clinical trials document arrest and prevention of dental caries by silver diamine fluoride; this off-label use is now permissible and appropriate under U.S. law. A CDT code was approved for caries arresting medicaments for 2016 to facilitate documentation and billing. We present a systematic review, clinical indications, clinical protocol, and consent procedure to guide application for caries arrest treatment. PMID:26897901

Interleukin-5 Inhibitors for Severe Asthma: Rationale and Future Outlook.

PubMed

Shrimanker, Rahul; Pavord, Ian D

2017-04-01

In this review, we outline the pathophysiology of severe asthma and discuss the role of anti-interleukin (IL)-5 inhibitors for the treatment of asthma. Anti-IL-5 treatments have shown efficacy in reducing the rate of severe asthma attacks in eosinophilic asthma. We review the history of the development of these agents, lessons learnt about severe asthma along the way and key clinical trials supporting efficacy of the three anti-IL-5 treatments that are clinically available or undergoing clinical trials in asthma.

Counseling women with early pregnancy failure: utilizing evidence, preserving preference.

PubMed

Wallace, Robin R; Goodman, Suzan; Freedman, Lori R; Dalton, Vanessa K; Harris, Lisa H

2010-12-01

To apply principles of shared decision-making to EPF management counseling. To present a patient treatment priority checklist developed from review of available literature on patient priorities for EPF management. Review of evidence for patient preferences; personal, emotional, physical and clinical factors that may influence patient priorities for EPF management; and the clinical factors, resources, and provider bias that may influence current practice. Women have strong and diverse preferences for EPF management and report higher satisfaction when treated according to these preferences. However, estimates of actual treatment patterns suggest that current practice does not reflect the evidence for safety and acceptability of all options, or patient preferences. Multiple practice barriers and biases exist that may be influencing provider counseling about options for EPF management. Choosing management for EPF is a preference-sensitive decision. A patient-centered approach to EPF management should incorporate counseling about all treatment options. Providers can integrate a counseling model into EPF management practice that utilizes principles of shared decision-making and an organized method for eliciting patient preferences, priorities, and concerns about treatment options. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Nurse leaders as stewards at the point of service.

PubMed

Murphy, Norma; Roberts, Deborah

2008-03-01

Nurse leaders, including clinical nurse educators, who exercise stewardship at the point of service, may facilitate practising nurses' articulation of their shared value priorities, including respect for persons' dignity and self-determination, as well as equity and fairness. A steward preserves and promotes what is intrinsically valuable in an experience. Theories of virtue ethics and discourse ethics supply contexts for clinical nurse educators to clarify how they may facilitate nurses' articulation of their shared value priorities through particularism and universalism, as well as how they may safeguard nurses' self-interpretation and discursive reasoning. Together, clinical nurse educators and nurses may contribute to management decisions that affect the point of service, and thus the health care organization.

Is evaluating complementary and alternative medicine equivalent to evaluating the absurd?

PubMed

Greasley, Pete

2010-06-01

Complementary and alternative therapies such as reflexology and acupuncture have been the subject of numerous evaluations, clinical trials, and systematic reviews, yet the empirical evidence in support of their efficacy remains equivocal. The empirical evaluation of a therapy would normally assume a plausible rationale regarding the mechanism of action. However, examination of the historical background and underlying principles for reflexology, iridology, acupuncture, auricular acupuncture, and some herbal medicines, reveals a rationale founded on the principle of analogical correspondences, which is a common basis for magical thinking and pseudoscientific beliefs such as astrology and chiromancy. Where this is the case, it is suggested that subjecting these therapies to empirical evaluation may be tantamount to evaluating the absurd.

The Sleep Apnea cardioVascular Endpoints (SAVE) Trial: Rationale, Ethics, Design, and Progress

PubMed Central

Antic, Nick A.; Heeley, Emma; Anderson, Craig S.; Luo, Yuanming; Wang, Jiguang; Neal, Bruce; Grunstein, Ron; Barbe, Ferran; Lorenzi-Filho, Geraldo; Huang, Shaoguang; Redline, Susan; Zhong, Nanshan; McEvoy, R. Doug

2015-01-01

The Sleep Apnea cardioVascular Endpoints (SAVE) study is an ongoing investigator-initiated and conducted, international, multicenter, open, blinded endpoint, randomized controlled trial that was designed to determine whether treatment of obstructive sleep apnea (OSA) with continuous positive airways pressure (CPAP) can reduce the risk of serious cardiovascular (CV) events in patients with established CV disease (clinical trial registration NCT00738179). The results of this study will have important implications for the provision of health care to patients with sleep apnea around the world. The SAVE study has brought together respiratory, sleep, CV and stroke clinicians-scientists in an interdisciplinary collaboration with industry and government sponsorship to conduct an ambitious clinical trial. Following its launch in Australia and China in late 2008, the recruitment network expanded across 89 sites that included New Zealand, India, Spain, USA, and Brazil for a total of 2,717 patients randomized by December 2013. These patients are being followed until December 2015 so that the average length of follow-up of the cohort will be over 4 y. This article describes the rationale for the SAVE study, considerations given to the design including how various cultural and ethical challenges were addressed, and progress in establishing and maintaining the recruitment network, patient follow-up, and adherence to CPAP and procedures. The assumptions underlying the original trial sample size calculation and why this was revised downward in 2012 are also discussed. Clinical Trials Registration Number: NCT00738179. Australia New Zealand Clinical Trials Registry Number: ACTRN12608000409370. Citation: Antic NA, Heeley E, Anderson CS, Luo Y, Wang J, Neal B, Grunstein R, Barbe F, Lorenzi-Filho G, Huang S, Redline S, Zhong N, McEvoy RD. The sleep apnea cardiovascular endpoints (SAVE) trial: rationale, ethics, design, and progress. SLEEP 2015;38(8):1247–1257. PMID:25669180

Divergence and convergence of commercial and scientific priorities in drug development: The case of Zelmid, the first SSRI antidepressant.

PubMed

Mulinari, Shai

2015-08-01

Based on a realist conceptualization of interests, this paper explores how commercial and scientific priorities appear to have converged and diverged during the development of the antidepressant Zelmid. The drug represents the first of the selective serotonin reuptake inhibitors (SSRIs) to reach the market. Zelmid was synthesized in 1971 and launched by the Swedish firm Astra in 1982, but subsequently withdrawn the next year because of adverse neurological effects. This paper draws on in-depth interviews with scientists representing both industry and academia who had high-level involvement in various phases of the project (experimental, pre-clinical and clinical), as well as on textual sources such as scientific articles and memoirs. Zelmid was a product of mechanism-based or "rational" drug discovery from the early 1960s and the associated intermingling of science and commerce. It is argued that both scientists and the pharmaceutical company shared an interest in embracing mechanism-based drug discovery because it simultaneously promised medico-scientific advances and profits. However, the intermingling of science and commerce also strained the relationship between scientific and commercial priorities further along the trajectory of the drug; for example, concerning issues such as dosage strategy and drug use in primary care, where corporate management allegedly took decisions contrary to the recommendations of both academic and company scientists. On such occasions the asymmetry in power became apparent in scientists' narratives: commercial considerations trumped those of science since, ultimately, decisions rest with management, not with scientists. In addition, temporality appears to be associated with the divergence of commercial and scientific priorities. While rare during experimental and pre-clinical phases, divergence was concentrated downstream to the clinical testing and post-marketing phases. It is hypothesized that a similar pattern of convergence and divergence of commercial and scientific priorities may exist in the trajectory of other drugs. Copyright © 2015 The Author. Published by Elsevier Ltd.. All rights reserved.

Clinical Indications for Carbon Ion Radiotherapy and Radiation Therapy with Other Heavier Ions

NASA Astrophysics Data System (ADS)

Combs, Stephanie E.

A number of studies have shown excellent and convincing clinical results for various indications after treatment with ions heavier than protons. These include skull base chordomas and chondrosarcomas, hepatocellular carcinomas, recurrent rectal cancer, high-risk meningiomas, or soft-tissue and bone sarcomas. This chapter outlines these trials and provides a medical rationale for their choice before they are discussed in depth in subsequent chapters.

Perspectives of Patients, Caregivers and Researchers on Research Priorities in Donation and Transplantation in Canada: A Pilot Workshop.

PubMed

Allard, Julie; Durand, Céline; Anthony, Samantha J; Dumez, Vincent; Hartell, David; Hébert, Marie-Josée; West, Lori J; Wright, Linda; Fortin, Marie-Chantal

2017-02-01

It is vitally important to seek input from key stakeholders to increase the quality and relevance of health-related research and accelerate its adoption into practice. Patients and caregivers have rarely been involved in setting research priorities in the transplantation and donation field. The objectives of this explorative study are: (i) to discuss research priorities within the Canadian National Transplant Research Program during a priority-setting exercise with patients, caregivers, organ donors and researchers and (ii) to compare the identified priorities with research published in 2 prestigious transplantation journals. A pilot workshop attended by 10 patients and caregivers and 5 researchers was held in Montréal (Quebec, Canada) in August 2014 to identify research priorities. Priorities were identified using a thematic analysis of the workshop transcription conducted by multiple coders. These priorities were compared with the topics of research articles published in 2 major transplantation journals between 2012 and 2014. The themes of the 10 research priorities identified by study participants were related to different research domains: social, cultural, and environmental health factors (4); biomedical or clinical (4); and research about health systems and services (2). 26.7% of the research articles published were related to the identified priorities. Thirteen percent looked at ways to improve graft survival and 8.5% looked at the development of tolerance, 2 priorities identified by participants. Fewer than 5% examined the other 8 research priorities identified as important by workshop participants. This is the first study reporting patients' and researchers' priorities in the field of transplantation and donation in Canada. There is a discrepancy between topics that key stakeholders find important and research published in 2 major transplantation journals. The research priorities identified during our initial workshop will be validated through a national survey and workshop.

Teaching Prevention in Internal Medicine Clerkships.

ERIC Educational Resources Information Center

Kinsinger, Linda

2000-01-01

Reviews the rationale for including prevention in the clinical medicine clerkship. Summarizes current guidelines, presents examples of curricula in several medical schools, and proposes a future direction that stresses integrating teaching preventive medicine into internal medicine clerkships and across the entire four-year medical curriculum. (DB)

Increasing Prevalence Rate of Nontuberculous Mycobacteria Infections in Five States, 2008–2013

EPA Science Inventory

Rationale: Many nontuberculous mycobacteria (NTM) are clinically significant pathogens that cause disease in a variety of different human organs and tissues. Objectives: A population-based study was undertaken to investigate the prevalence of patients with a positive specimen fo...

A few of our favorite unconfirmed ideas

PubMed Central

2015-01-01

Medical practice is rooted in our dependence on the best available evidence from incremental scientific experimentation and rigorous clinical trials. Progress toward determining the true worth of ongoing practice or suggested innovations can be glacially slow when we insist on following the stepwise scientific pathway, and a prevailing but imperfect paradigm often proves difficult to challenge. Yet most experienced clinicians and clinical scientists harbor strong thoughts about how care could or should be improved, even if the existing evidence base is thin or lacking. One of our Future of Critical Care Medicine conference sessions encouraged sharing of novel ideas, each presented with what the speaker considers a defensible rationale. Our intent was to stimulate insightful thinking and free interchange, and perhaps to point in new directions toward lines of innovative theory and improved care of the critically ill. In what follows, a brief background outlines the rationale for each novel and deliberately provocative unconfirmed idea endorsed by the presenter. PMID:26728101

The Harvard/Brown Anxiety Research Project – Phase II (HARP-II): Rationale, methods, and features of the sample at intake

PubMed Central

Weisberg, Risa B.; Beard, Courtney; Dyck, Ingrid; Keller, Martin B.

2012-01-01

We describe the rationale, method, and intake demographic and clinical findings of the Harvard/Brown Anxiety Research Project-Phase II (HARP-II). HARP-II is the first prospective, observational, longitudinal study to describe the characteristics and course of anxiety in African American, Latino, and Non-Latino White individuals. Participants met criteria for at least one of the following disorders: Generalized Anxiety Disorder, Social Phobia, Panic Disorder with or without Agoraphobia, Agoraphobia without history of Panic Disorder, Posttraumatic Stress Disorder. Initial intake data, collected between 2004 and 2011, are presented for 165 African American, 150 Latino, and 172 Non-Latino White participants. Participants evidenced substantial psychiatric comorbidity (mean number of Axis I disorders = 3.4), and moderate to severe symptoms and functional impairment. HARP-II will examine clinical course, in the context of potential socio-cultural and individual moderators (e.g., discrimination, acculturation, negative affect). Results should lead to improved understanding, prognostics, and treatment of anxiety in diverse populations. PMID:22410095

Pilot study: incorporation of pharmacogenetic testing in medication therapy management services.

PubMed

Haga, Susanne B; Allen LaPointe, Nancy M; Moaddeb, Jivan; Mills, Rachel; Patel, Mahesh; Kraus, William E

2014-11-01

Aim: To describe the rationale and design of a pilot study evaluating the integration of pharmacogenetic (PGx) testing into pharmacist-delivered medication therapy management (MTM). Study rationale: Clinical delivery approaches of PGx testing involving pharmacists may overcome barriers of limited physician knowledge about and experience with testing. Study design: We will assess the addition of PGx testing to MTM services for cardiology patients taking three or more medications including simvastatin or clopidogrel. We will measure the impact of MTM plus PGx testing on drug/dose adjustment and clinical outcomes. Factors associated with delivery, such as time to prepare and conduct MTM and consult with physicians will be recorded. Additionally, patient interest and satisfaction will be measured. Anticipated results: We anticipate that PGx testing can be practically integrated into standard a MTM service, providing a viable delivery model for testing. Conclusion: Given the lack of evidence of an effective PGx delivery models, this study will provide preliminary evidence regarding a pharmacist-delivered approach.

Personalizing, not patronizing: the case for patient autonomy by unbiased presentation of management options in stage I testicular cancer.

PubMed

Oldenburg, J; Aparicio, J; Beyer, J; Cohn-Cedermark, G; Cullen, M; Gilligan, T; De Giorgi, U; De Santis, M; de Wit, R; Fosså, S D; Germà-Lluch, J R; Gillessen, S; Haugnes, H S; Honecker, F; Horwich, A; Lorch, A; Ondruš, D; Rosti, G; Stephenson, A J; Tandstad, T

2015-05-01

Testicular cancer (TC) is the most common neoplasm in males aged 15-40 years. The majority of patients have no evidence of metastases at diagnosis and thus have clinical stage I (CSI) disease [Oldenburg J, Fossa SD, Nuver J et al. Testicular seminoma and non-seminoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2013; 24(Suppl 6): vi125-vi132; de Wit R, Fizazi K. Controversies in the management of clinical stage I testis cancer. J Clin Oncol 2006; 24: 5482-5492.]. Management of CSI TC is controversial and options include surveillance and active treatment. Different forms of adjuvant therapy exist, including either one or two cycles of carboplatin chemotherapy or radiotherapy for seminoma and either one or two cycles of cisplatin-based chemotherapy or retroperitoneal lymph node dissection for non-seminoma. Long-term disease-specific survival is ∼99% with any of these approaches, including surveillance. While surveillance allows most patients to avoid additional treatment, adjuvant therapy markedly lowers the relapse rate. Weighing the net benefits of surveillance against those of adjuvant treatment depends on prioritizing competing aims such as avoiding unnecessary treatment, avoiding more burdensome treatment with salvage chemotherapy and minimizing the anxiety, stress and life disruption associated with relapse. Unbiased information about the advantages and disadvantages of surveillance and adjuvant treatment is a prerequisite for informed consent by the patient. In a clinical scenario like CSI TC, where different disease-management options produce indistinguishable long-term survival rates, patient values, priorities and preferences should be taken into account. In this review, we provide an overview about risk factors for relapse, potential benefits and harms of adjuvant chemotherapy and active surveillance and a rationale for involving patients in individualized decision making about their treatment rather than adopting a uniform recommendation for all. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Priority setting partnership to identify the top 10 research priorities for the management of Parkinson's disease.

PubMed

Deane, Katherine H O; Flaherty, Helen; Daley, David J; Pascoe, Roland; Penhale, Bridget; Clarke, Carl E; Sackley, Catherine; Storey, Stacey

2014-12-14

This priority setting partnership was commissioned by Parkinson's UK to encourage people with direct and personal experience of the condition to work together to identify and prioritise the top 10 evidential uncertainties that impact on everyday clinical practice for the management of Parkinson's disease (PD). The UK. Anyone with experience of PD including: people with Parkinson's (PwP), carers, family and friends, healthcare and social care professionals. Non-clinical researchers and employees of pharmaceutical or medical devices companies were excluded. 1000 participants (60% PwP) provided ideas on research uncertainties, 475 (72% PwP) initially prioritised them and 27 (37% PwP) stakeholders agreed a final top 10. Using a modified nominal group technique, participants were surveyed to identify what issues for the management of PD needed research. Unique research questions unanswered by current evidence were identified and participants were asked to identify their top 10 research priorities from this list. The top 26 uncertainties were presented to a consensus meeting with key stakeholders to agree the top 10 research priorities. 1000 participants provided 4100 responses, which contained 94 unique unanswered research questions that were initially prioritised by 475 participants. A consensus meeting with 27 stakeholders agreed the top 10 research priorities. The overarching research aspiration was an effective cure for PD. The top 10 research priorities for PD management included the need to address motor symptoms (balance and falls, and fine motor control), non-motor symptoms (sleep and urinary dysfunction), mental health issues (stress and anxiety, dementia and mild cognitive impairments), side effects of medications (dyskinesia) and the need to develop interventions specific to the phenotypes of PD and better monitoring methods. These research priorities identify crucial gaps in the existing evidence to address everyday practicalities in the management of the complexities of PD. 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.

Priority setting partnership to identify the top 10 research priorities for the management of Parkinson's disease

PubMed Central

Deane, Katherine H O; Flaherty, Helen; Daley, David J; Pascoe, Roland; Penhale, Bridget; Clarke, Carl E; Sackley, Catherine; Storey, Stacey

2014-01-01

Objectives This priority setting partnership was commissioned by Parkinson's UK to encourage people with direct and personal experience of the condition to work together to identify and prioritise the top 10 evidential uncertainties that impact on everyday clinical practice for the management of Parkinson's disease (PD). Setting The UK. Participants Anyone with experience of PD including: people with Parkinson's (PwP), carers, family and friends, healthcare and social care professionals. Non-clinical researchers and employees of pharmaceutical or medical devices companies were excluded. 1000 participants (60% PwP) provided ideas on research uncertainties, 475 (72% PwP) initially prioritised them and 27 (37% PwP) stakeholders agreed a final top 10. Methods Using a modified nominal group technique, participants were surveyed to identify what issues for the management of PD needed research. Unique research questions unanswered by current evidence were identified and participants were asked to identify their top 10 research priorities from this list. The top 26 uncertainties were presented to a consensus meeting with key stakeholders to agree the top 10 research priorities. Results 1000 participants provided 4100 responses, which contained 94 unique unanswered research questions that were initially prioritised by 475 participants. A consensus meeting with 27 stakeholders agreed the top 10 research priorities. The overarching research aspiration was an effective cure for PD. The top 10 research priorities for PD management included the need to address motor symptoms (balance and falls, and fine motor control), non-motor symptoms (sleep and urinary dysfunction), mental health issues (stress and anxiety, dementia and mild cognitive impairments), side effects of medications (dyskinesia) and the need to develop interventions specific to the phenotypes of PD and better monitoring methods. Conclusions These research priorities identify crucial gaps in the existing evidence to address everyday practicalities in the management of the complexities of PD. PMID:25500772

Delayed reward discounting and addictive behavior: a meta-analysis

PubMed Central

Amlung, Michael T.; Few, Lauren R.; Ray, Lara A.; Sweet, Lawrence H.; Munafò, Marcus R.

2011-01-01

Rationale Delayed reward discounting (DRD) is a behavioral economic index of impulsivity and numerous studies have examined DRD in relation to addictive behavior. To synthesize the findings across the literature, the current review is a meta-analysis of studies comparing DRD between criterion groups exhibiting addictive behavior and control groups. Objectives The meta-analysis sought to characterize the overall patterns of findings, systematic variability by sample and study type, and possible small study (publication) bias. Methods Literature reviews identified 310 candidate articles from which 46 studies reporting 64 comparisons were identified (total N=56,013). Results From the total comparisons identified, a small magnitude effect was evident (d=.15; p<.00001) with very high heterogeneity of effect size. Based on systematic observed differences, large studies assessing DRD with a small number of self-report items were removed and an analysis of 57 comparisons (n=3,329) using equivalent methods and exhibiting acceptable heterogeneity revealed a medium magnitude effect (d=.58; p<.00001). Further analyses revealed significantly larger effect sizes for studies using clinical samples (d=.61) compared with studies using nonclinical samples (d=.45). Indices of small study bias among the various comparisons suggested varying levels of influence by unpublished findings, ranging from minimal to moderate. Conclusions These results provide strong evidence of greater DRD in individuals exhibiting addictive behavior in general and particularly in individuals who meet criteria for an addictive disorder. Implications for the assessment of DRD and research priorities are discussed. PMID:21373791

Apatinib concurrent gemcitabine for controlling malignant ascites in advanced pancreatic cancer patient

PubMed Central

Liang, Lijun; Wang, Lei; Zhu, Panrong; Xia, Youyou; Qiao, Yun; Hui, Kaiyuan; Hu, Chenxi; Ren, Yan; Jiang, Xiaodong

2017-01-01

Abstract Rationale: Malignant ascites (MA) is one of the poor prognostic factors for advanced pancreatic cancer and can bring about serious symptoms. The improvement of quality of life for patients is priority. However, there is no standard method for the treatment for pancreatic cancer-mediated MA. Apatinib is a novel and highly selective tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2. There are no reports of concurrent apatinib with gemcitabine in patients with pancreatic cancer-mediated MA. Patient concerns: Herein, we presented a 64-year-old man patient who visited hospital due to abdominal pain for 1 month. Diagnoses: He was initially diagnosed with pancreatic cancer and his first symptom was MA. Interventions: After failing in tube drainage and gemcitabine therapy, the patient received gemcitabine combined apatinib orally and after administrated 1 month, the MA was evaluated as nearly clear response according to the RECIST 1.1 standard, and without further need of paracentesis. The CEA and CA199 reached the lowest level after administrating for 2.5 months during the treatment process. Outcomes: 10.5 months following apatinib administration, the patient achieved a progression-free survival for more than 11 months. Hypertension (grade IV), hand-foot syndrome (grade I) and proteinuria (grade II) were observed. Lessons: It indicated that apatinib concurrent gemcitabine may be a superior choice for pancreatic cancer-mediated MA. Further clinical trials required to confirm its efficacy and safety. PMID:29381963

Rationale, timeline, study design, and protocol overview of the therapeutic hypothermia after pediatric cardiac arrest trials.

PubMed

Moler, Frank W; Silverstein, Faye S; Meert, Kathleen L; Clark, Amy E; Holubkov, Richard; Browning, Brittan; Slomine, Beth S; Christensen, James R; Dean, J Michael

2013-09-01

To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Multicenter randomized controlled trials. Pediatric intensive care and cardiac ICUs in the United States and Canada. Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Therapeutic hypothermia or therapeutic normothermia. From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials.

High Priority Future Research Needs for Obstructive Sleep Apnea Diagnosis and Treatment

PubMed Central

Patel, Kamal; Moorthy, Denish; Chan, Jeffrey A.; Concannon, Thomas W.; Ratichek, Sara J.; Chung, Mei; Balk, Ethan M.

2013-01-01

Study Objectives: To identify and prioritize future research needs (FRN) topics for diagnosis and treatment of obstructive sleep apnea (OSA). Methods: Twenty-one panel members represented six stake-holder categories: patients and the public, providers; purchasers of health care, payers, policymakers, and principal investigators. Building on a recently completed comparative effectiveness review, stakeholders nominated and discussed potential FRN topics. Stakeholders then nominated their top priority FRN topics based on the Agency for Healthcare Research and Quality Effective Health Care Program Selection Criteria. From these nominations, the highest priority FRN topics were determined and were elaborated upon to include possible study designs to address the topics. Results: Thirty-seven topics were discussed and prioritized. The nine highest priority FRN topics included: cost-effectiveness of management strategies, defining age- and sex-specific criteria for OSA, evaluating routine preoperative screening for OSA, evaluating involvement of a sleep medicine specialist in diagnosis of OSA, evaluating clinical prediction rules, assessing the effect of treating sleep disordered breathing and long-term clinical outcomes, comparing treatments for patients who do not tolerate positive airway pressure, evaluating strategies to improve treatment compliance, and evaluating the association between sleep apnea severity and long-term clinical outcomes. Conclusions: While there are numerous specific research questions with low or insufficient strength of evidence for OSA management, OSA patients, their healthcare providers, and society at large would benefit from refocusing research efforts into the prioritized research questions and away from simple comparisons of short-term outcomes between specific interventions. Citation: Patel K; Moorthy D; Chan JA; Concannon TW. High priority future research needs for obstructive sleep apnea diagnosis and treatment. J Clin Sleep Med 2013;9(4):395-402. PMID:23585757

Establishing research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus.

PubMed

Turner, Grace M; Backman, Ruth; McMullan, Christel; Mathers, Jonathan; Marshall, Tom; Calvert, Melanie

2018-01-01

What is the problem and why is this important? Mini-strokes are similar to full strokes, but symptoms last less than 24 h. Many people (up to 70%) have long-term problems after a mini-stroke, such as anxiety; depression; problems with brain functioning (like memory loss); and fatigue (feeling tired). However, the current healthcare pathway only focuses on preventing another stroke and care for other long-term problems is not routinely given. Without proper treatment, people with long-term problems after a mini-stroke could have worse quality of life and may find it difficult to return to work and their social activities. What is the aim of the research? We wanted to understand the research priorities of patients, health care professionals and key stakeholders relating to the long-term impact of mini-stroke. How did we address the problem? We invited patients, clinicians, researchers and other stakeholders to attend a meeting. At the meeting people discussed the issues relating to the long-term impact of mini-stroke and came to an agreement on their research priorities. There were three stages: (1) people wrote down their individual research suggestions; (2) in smaller groups people came to an agreement on what their top research questions were; and (3) the whole group agreed final research priorities. What did we find? Eleven people attended who were representatives for patients, GPs, stroke consultants, stroke nurses, psychologists, the Stroke Association (charity) and stroke researchers, The group agreed on eleven research questions which they felt were the most important to improve health and well-being for people who have had a mini-stroke.The eleven research questions encompass a range of categories, including: understanding the existing care patients receive (according to diagnosis and geographical location); exploring what optimal care post-TIA/minor stroke should comprise (identifying and treating impairments, information giving and support groups) and how that care should be delivered (clinical setting and follow-up pathway); impact on family members; and education/training for health care professionals. Background Clinical management after transient ischaemic attack (TIA) and minor stroke focuses on stroke prevention. However, evidence demonstrates that many patients experience ongoing residual impairments. Residual impairments post-TIA and minor stroke may affect patients' quality of life and return to work or social activities. Research priorities of patients, health care professionals and key stakeholders relating to the long-term impact of TIA and minor stroke are unknown. Methods Our objective was to establish the top shared research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus. A one-day priority setting consensus meeting took place with representatives from different stakeholder groups in October 2016 (Birmingham, UK). Nominal group technique was used to establish research priorities. This involved three stages: (i) gathering research priorities from individual stakeholders; (ii) interim prioritisation in three subgroups; and (iii) final priority setting. Results The priority setting consensus meeting was attended by 11 stakeholders. The individual stakeholders identified 34 different research priorities. During the interim prioritisation exercise, the three subgroups generated 24 unique research priorities which were discussed as a whole group. Following the final consensus discussion, 11 shared research priorities were unanimously agreed.The 11 research questions encompass a range of categories, including: understanding the existing care patients receive (according to diagnosis and geographical location); exploring what optimal care post-TIA/minor stroke should comprise (identifying and treating impairments, information giving and support groups) and how that care should be delivered (clinical setting and follow-up pathway); impact on family members; and education/training for health care professionals. Conclusions Eleven different research priorities were established through stakeholder-centred consensus. These research questions could usefully inform the research agenda and policy decisions for TIA and minor stroke. Inclusion of stakeholders in setting research priorities is important to increase the relevance of research and reduce research waste.

Patients', clinicians' and the research communities' priorities for treatment research: there is an important mismatch.

PubMed

Crowe, Sally; Fenton, Mark; Hall, Matthew; Cowan, Katherine; Chalmers, Iain

2015-01-01

There is some evidence that there is a mismatch between what patients and health professionals want to see researched and the research that is actually done. The James Lind Alliance (JLA) research Priority Setting Partnerships (PSPs) were created to address this mismatch. Between 2007 and 2014, JLA partnerships of patients, carers and health professionals agreed on important treatment research questions (priorities) in a range of health conditions, such as Type 1 diabetes, eczema and stroke. We were interested in how much these JLA PSP priorities were similar to treatments undergoing evaluation and research over the same time span. We identified the treatments described in all the JLA PSP research priority lists and compared these to the treatments described in a group of research studies (randomly selected) registered publically. The priorities identified by JLA PSPs emphasised the importance of non-drug treatment research, compared to the research actually being done over the same time period, which mostly involved evaluations of drugs. These findings suggest that the research community should make greater efforts to address issues of importance to users of research, such as patients and healthcare professionals. Background Comparisons of treatment research priorities identified by patients and clinicians with research actually being done by researchers are very rare. One of the best known of these comparisons (Tallon et al. Relation between agendas of the research community and the research consumer 355:2037-40, 2000) revealed important mismatches in priorities in the assessment of treatments for osteoarthritis of the knee: researchers preferenced drug trials, patients and clinicians prioritised non-drug treatments. These findings were an important stimulus in creating the James Lind Alliance (JLA). The JLA supports research Priority Setting Partnerships (PSPs) of patients, carers and clinicians, who are actively involved in all aspects of the process, to develop shared treatment research priorities. We have compared the types of treatments (interventions) prioritised for evaluation by JLA PSPs with those being studied in samples of clinical trials being done over the same period. Objective We used treatment research priorities generated by JLA PSPs to assess whether, on average, treatments prioritised by patients and clinicians differ importantly from those being studied by researchers. Methods We identified treatments mentioned in prioritised research questions generated by the first 14 JLA PSPs. We compared these treatments with those assessed in random samples of commercial and non-commercial clinical trials recruiting in the UK over the same period, which we identified using WHO's International Clinical Trials Registry Platform. Results We found marked differences between the proportions of different types of treatments proposed by patients, carers and clinicians and those currently being evaluated by researchers. In JLA PSPs, drugs accounted for only 18 % (23/126) of the treatments mentioned in priorities; in registered non-commercial trials, drugs accounted for 37 % (397/1069) of the treatments mentioned; and in registered commercial trials, drugs accounted for 86 % (689/798) of the treatments mentioned. Discussion Our findings confirm the mismatch first described by Tallon et al. 15 years ago. On average, drug trials are being preferenced by researchers, and non-drug treatments are preferred by patients, carers and clinicians. This general finding should be reflected in more specific assessments of the extent to which research is addressing priorities identified by the patient and clinician end users of research. It also suggests that the research culture is slow to change in regard to how important and relevant treatment research questions are identified and prioritised.

Creating an innovative youth mental health service in the United Kingdom: The Norfolk Youth Service.

PubMed

Wilson, Jon; Clarke, Tim; Lower, Rebecca; Ugochukwu, Uju; Maxwell, Sarah; Hodgekins, Jo; Wheeler, Karen; Goff, Andy; Mack, Robert; Horne, Rebecca; Fowler, David

2017-08-04

Young people attempting to access mental health services in the United Kingdom often find traditional models of care outdated, rigid, inaccessible and unappealing. Policy recommendations, research and service user opinion suggest that reform is needed to reflect the changing needs of young people. There is significant motivation in the United Kingdom to transform mental health services for young people, and this paper aims to describe the rationale, development and implementation of a novel youth mental health service in the United Kingdom, the Norfolk Youth Service. The Norfolk Youth Service model is described as a service model case study. The service rationale, national and local drivers, principles, aims, model, research priorities and future directions are reported. The Norfolk Youth Service is an innovative example of mental health transformation in the United Kingdom, comprising a pragmatic, assertive and "youth-friendly" service for young people aged 14 to 25 that transcends traditional service boundaries. The service was developed in collaboration with young people and partnership agencies and is based on an engaging and inclusive ethos. The service is a social-recovery oriented, evidence-based and aims to satisfy recent policy guidance. The redesign and transformation of youth mental health services in the United Kingdom is long overdue. The Norfolk Youth Service represents an example of reform that aims to meet the developmental and transitional needs of young people at the same time as remaining youth-oriented. © 2017 John Wiley & Sons Australia, Ltd.

Recycled water for stream flow augmentation: benefits, challenges, and the presence of wastewater-derived organic compounds.

PubMed

Plumlee, Megan H; Gurr, Christopher J; Reinhard, Martin

2012-11-01

Stream flow augmentation with recycled water has the potential to improve stream habitat and increase potable water supply, but the practice is not yet well understood or documented. The objectives of this report are to present a short review illustrated by a case study, followed by recommendations for future stream flow augmentation projects. Despite the fact that wastewater discharge to streams is commonplace, a water agency pursuing stream flow augmentation with recycled water will face unique challenges. For example, recycled water typically contains trace amounts of organic wastewater-derived compounds (OWCs) for which the potential ecological risks must be balanced against the benefits of an augmentation project. Successful stream flow augmentation with recycled water requires that the lead agency clearly articulate a strong project rationale and identify key benefits. It must be assumed that the public will have some concerns about water quality. Public acceptance may be better if an augmentation project has co-benefits beyond maintaining stream ecosystems, such as improving water system supply and reliability (i.e. potable use offset). Regulatory or project-specific criteria (acceptable concentrations of priority OWCs) would enable assessment of ecosystem impacts and demonstration of practitioner compliance. Additional treatment (natural or engineered) of the recycled water may be considered. If it is not deemed necessary or feasible, existing recycled water quality may be adequate to achieve project goals depending on project rationale, site and water quality evaluation, and public acceptance.

A community-based obesity prevention program for minority children: rationale and study design for Hip-Hop to Health Jr.

PubMed

Fitzgibbon, Marian L; Stolley, Melinda R; Dyer, Alan R; VanHorn, Linda; KauferChristoffel, Katherine

2002-02-01

BACKGROUND; The increasing prevalence of overweight among children in the United States presents a national health priority. Higher rates of overweight/obesity among minority women place their children at increased risk. Although increased rates of overweight are observed in 4- to 5-year-old children, they are not observed in 2- to 3-year-old children. Therefore, early prevention efforts incorporating families are critical. The primary aim of Hip-Hop to Health Jr. is to alter the trajectory toward overweight/obesity among preschool African-American and Latino children. This 5-year randomized intervention is conducted in 24 Head Start programs, where each site is randomized to either a 14-week dietary/physical activity intervention or a general health intervention. This paper presents the rationale and design of the study. Efficacy of the intervention will be determined by weight change for the children and parent/caretaker. Secondary measures include reductions in dietary fat and increases in fiber, fruit/vegetable intake, and physical activity. Baseline data will be presented in future papers. The problem of overweight/obesity is epidemic in the United States. Behaviors related to diet and physical activity are established early in life and modeled by family members. Early intervention efforts addressing the child and family are needed to prevent obesity later in life. This paper describes a comprehensive, family-oriented obesity prevention program for minority preschool children. Copyright 2002 American Health Foundation and Elsevier Science (USA).

Music Therapy in the Rehabilitation of Head-Injured Clients.

ERIC Educational Resources Information Center

Lee, Lissa

This paper summarizes research on clinical applications of music therapy with closed head injury clients. It offers a rationale for including music therapy in interdisciplinary rehabilitation. The Rancho Los Amigos Levels of Cognitive Functioning are outlined, and therapeutic assessment and treatment procedures are discussed. Rehabilitation…

Spiritual Assessment in Counseling: Methods and Practice

ERIC Educational Resources Information Center

Oakes, K. Elizabeth; Raphel, Mary M.

2008-01-01

Given the widely expanding professional and empirical support for integrating spirituality into counseling, the authors present a practical discussion for raising counselors' general awareness and skill in the critical area of spiritual assessment. A discussion of rationale, measurement, and clinical practice is provided along with case examples.…

Introduction to the Ninth Edition

PubMed Central

Akl, Elie A.; Crowther, Mark; Schünemann, Holger J.; Gutterman, David D.; Zelman Lewis, Sandra

2012-01-01

The Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines differs substantially from the prior versions both in process and in content. In this introduction, we describe some of the differences and the rationale for the changes. PMID:22315255

Culture-Specific Testing: Part 1.

ERIC Educational Resources Information Center

Williams, Robert L., Ed.

1981-01-01

In five articles provides a rationale for the development of culturally specific tests, presents research on their use, and discusses clinical uses. Focuses on two Afro-centric projective tests: The Thematic Apperception Test and Themes Concerning Blacks. Criticizes use of traditional projective tests and points out viable alternatives. (JAC)

Non-speech oro-motor exercise use in acquired dysarthria management: regimes and rationales.

PubMed

Mackenzie, Catherine; Muir, Margaret; Allen, Carolyn

2010-01-01

Non-speech oro-motor exercises (NSOMExs) are described in speech and language therapy manuals and are thought to be much used in acquired dysarthria intervention, though there is no robust evidence of an influence on speech outcome. Opinions differ as to whether, and for which dysarthria presentations, NSOMExs are appropriate. The investigation sought to collect development-phase data, in accordance with the Medical Research Council (MRC) evaluation of complex interventions. The aims were to establish the extent of use of NSOMExs in acquired disorders, the exercise regimes in use for dysarthria, with which dysarthric populations, and the anticipated clinical outcomes. A further aim was to determine the influencing rationales where NSOMExs were or were not used in dysarthria intervention. Speech and language therapists throughout Scotland, Wales, and Northern Ireland, working with adult-acquired dysarthria, were identified by their service heads. They received postal questionnaires comprising 21 closed and two open questions, covering respondent biographics, use of NSOMExs, anticipated clinical outcomes, and practice influencing rationales. One hundred and ninety-one (56% response) completed questionnaires were returned. Eighty-one per cent of respondents used NSOMExs in dysarthria. There was no association with years of speech and language therapy experience. Those who used and those who did not use NSOMExs provided similar influencing rationales, including evidence from their own practice, and Higher Education Institute teaching. More experienced speech and language therapists were more likely than those more recently qualified to be guided by results from their own practice. Input from the attended Higher Education Institute was more influential for those less experienced than for those more experienced. Clinical outcome aims were not confined to speech, but also included improvements in movement, sensory awareness, appearance, emotional status, dysphagia and drooling. NSOMExs were used with many neurological disorders, especially stroke, all dysarthria classes, especially flaccid, and all severity levels. Tongue and lip exercises were more frequent than face, jaw and soft palate. The most common regimes were four to six repetitions of each exercise, during three practice periods daily, each of 6–10 min. NSOMExs are a frequent component of dysarthria management in the UK-devolved government countries. This confirmation, along with the details of speech and language therapy practice, provides a foundation for clinical research which will compare outcomes for people with dysarthria, whose management includes and does not include NSOMExs. Speech and language therapy practice may be guided by evidence that speech outcome is or is not affected by NSOMExs.

Priorities for Antiretroviral Therapy Research in Sub-Saharan Africa: A 2002 Consensus Conference in Zambia

PubMed Central

Zulu, Isaac; Schuman, Paula; Musonda, Rosemary; Chomba, Elwyn; Mwinga, Kasonde; Sinkala, Moses; Chisembele, Maureen; Mwaba, Peter; Kasonde, Dorothy; Vermund, Sten H.

2009-01-01

Background A consensus conference was held to discuss priorities for antiretroviral therapy (ART) research in Zambia, one of the world’s most heavily HIV-afflicted nations. Zambia, like other resource-limited settings, has increasing access to highly active antiretroviral therapy (HAART) because of declining drug costs, use of government-purchased generic medications, and increased global donations. For sustained delivery of care with HAART in a resource-constrained medical and public health context, operational research is required and clinical trials are desirable. The priority areas for research are most relevant today given the increasing availability of HAART. Methods A conference was held in Lusaka, Zambia, in January 2002 to discuss priority areas for ART research in Zambia, with participants drawn from a broad cross section of Zambian society. State-of-the-art reviews and 6 intensive small group discussions helped to formulate a suggested research agenda. Results Conference participants believed that the most urgent research priorities were to assess how therapeutic resources could be applied for the greatest overall benefit and to minimize the impact of nonadherence and viral resistance. Identified research priorities were as follows: To determine when to initiate HAART in relation to CD4+ cell count To assess whether HIV/AIDS can be managed well without the use of costly frequent viral load measurements and CD4+ cell count monitoring To assess whether HIV/AIDS can be managed in the same fashion in patients coinfected with opportunistic infections such as tuberculosis and HIV-related chronic diarrhea, taking into consideration complications that may occur in tuberculosis such as immune reconstitution syndrome and medication malabsorption in the presence of diarrhea To carefully assess and characterize toxicities, adverse effects, and viral resistance patterns in Zambia, including studies of mothers exposed to prepartum single-dose nevirapine To conduct operational research to assess clinical and field-based strategies to maximize adherence for better outcomes of ART in Zambia To assess ART approaches most valuable for pediatric and adolescent patients in Zambia Conference participants recommended that HIV-related clinical care and research be integrated within home-based care services and operated within the existing health delivery structures to ensure sustainability, reduce costs, and strengthen the structures. Conclusion Our consensus was that antiretroviral clinical trials and operational research are essential for Zambia to address the new challenges arising from increasing ART availability. There is global consensus that antiretroviral clinical trials in resource-constrained countries are possible, and the capacity for such trials should be developed further in Africa. PMID:15213567

Total knee arthroplasty: good agreement of clinical severity scores between patients and consultants.

PubMed

Ebinesan, Ananthan D; Sarai, Bhupinder S; Walley, Gayle; Bridgman, Stephen; Maffulli, Nicola

2006-07-31

Nearly 20,000 patients per year in the UK receive total knee arthroplasty (TKA). One of the problems faced by the health services of many developed countries is the length of time patients spend waiting for elective treatment. We therefore report the results of a study in which the Salisbury Priority Scoring System (SPSS) was used by both the surgeon and their patients to ascertain whether there were differences between the surgeon generated and patient generated Salisbury Priority Scores. The Salisbury Priority Scoring System (SPSS) was used to assign relative priority to patients with knee osteoarthritis as part of a randomised controlled trial comparing the standard medial parapatellar approach versus the sub-vastus approach in TKA. The operating surgeons and each patient completed the SPSS at the same pre-assessment clinic. The SPSS assesses four criteria, namely progression of disease, pain or distress, disability or dependence on others, and loss of usual occupation. Crosstabs and agreement measures (Cohen's kappa) were performed. Overall, the four SPSS criteria showed a kappa value of 0.526, 0.796, 0.813, and 0.820, respectively, showing moderate to very good agreement between the patient and the operating consultant. Male patients showed better agreement than female patients. The Salisbury Priority Scoring System is a good means of assessing patients' needs in relation to elective surgery, with high agreement between the patient and the operating surgeon.

Effects of Role and Assignment Rationale on Attitudes Formed During Peer Tutoring

PubMed Central

Bierman, Karen Linn; Furman, Wyndol

2012-01-01

This study examined the role of contextual factors, such as assignment rationale, on the attitudinal effects of peer tutoring. Fourth-grade children engaged in brief tutoring experiences as either a tutor or tutee. Subjects received four rationales for being selected as tutor or tutee: (a) a competence rationale, (b) a physical characteristic rationale, (c) a chance rationale, or (d) no rationale. As predicted, tutors had more positive attitudes than tutees when they had been given a competence or physical characteristic rationale but not when the tutors were provided a chance rationale or no rationale. Additionally, the tutors’ and tutees’ attitudes were enhanced when no rationale was provided. Results are discussed in terms of their implications for a role-theory analysis of tutoring and their implications for applied programs. PMID:23946549

Effects of Role and Assignment Rationale on Attitudes Formed During Peer Tutoring.

PubMed

Bierman, Karen Linn; Furman, Wyndol

1981-02-01

This study examined the role of contextual factors, such as assignment rationale, on the attitudinal effects of peer tutoring. Fourth-grade children engaged in brief tutoring experiences as either a tutor or tutee. Subjects received four rationales for being selected as tutor or tutee: (a) a competence rationale, (b) a physical characteristic rationale, (c) a chance rationale, or (d) no rationale. As predicted, tutors had more positive attitudes than tutees when they had been given a competence or physical characteristic rationale but not when the tutors were provided a chance rationale or no rationale. Additionally, the tutors' and tutees' attitudes were enhanced when no rationale was provided. Results are discussed in terms of their implications for a role-theory analysis of tutoring and their implications for applied programs.

Casting a wider net for countermeasure R&D funding decisions.

PubMed

Klotz, Lynn

2007-12-01

Among potential bioweapons attacks, endemic infectious diseases (that is, those naturally occurring diseases that afflict us every year), and a potential influenza pandemic, how should we apportion funding and resources for basic research and countermeasure development? To address this question, I argue for a "combined risk assessment" that considers bioweapons attacks with natural pandemics and endemic infectious disease. At present, risk assessments for bioweapons attacks are carried out separately from the assessments long carried out for endemic infectious diseases to make public health and medical care decisions. One result of this separation is that funding decisions may be unduly influenced by an overblown fear of a big bioweapons attack and by political whim. The result of the simplified combined risk assessment presented here argues for more funding and resources for endemic infectious disease and for placing biodefense against anthrax and other bioweapons in a place lower in the risk hierarchy. Since the assessment here considers only fatalities to make the point that our priorities are skewed, the conclusions are only a "first word" on the subject, far from the last. Furthermore, the impact of other issues on priorities, such as national and international policy, is not considered. It is a call for a debate on the public stage of the policy and other rationale and the quantitative risk assessment arguments that now place bioweapons attacks at the top of our risk ranking.

Calculable People? Standardising Assessment Guidelines for Alzheimer’s Disease in 1980s Britain

PubMed Central

Wilson, Duncan

2017-01-01

This article shows how funding research on Alzheimer’s disease became a priority for the British Medical Research Council (MRC) in the late 1970s and 1980s, thanks to work that isolated new pathological and biochemical markers and showed that the disease affected a significant proportion of the elderly population. In contrast to histories that focus on the emergence of new and competing theories of disease causation in this period, I argue that concerns over the use of different assessment methods ensured the MRC’s immediate priority was standardising the ways in which researchers identified and recorded symptoms of Alzheimer’s disease in potential research subjects. I detail how the rationale behind the development of standard assessment guidelines was less about arriving at a firm diagnosis and more about facilitating research by generating data that could be easily compared across the disciplines and sites that constitute modern biomedicine. Drawing on criticism of specific tests in the MRC’s guidelines, which some psychiatrists argued were ‘middle class biased’, I also show that debates over standardisation did not simply reflect concerns specific to the fields or areas of research that the MRC sought to govern. Questions about the validity of standard assessment guidelines for Alzheimer’s disease embodied broader concerns about education and social class, which ensured that distinguishing normal from pathological in old age remained a contested and historically contingent process. PMID:28901868

A Systematic Review on the Designs of Clinical Technology: Findings and Recommendations for Future Research

PubMed Central

PhD, Greg Alexander; Staggers, Nancy

2010-01-01

Human factors (HF) studies are increasingly important as technology infuses into clinical settings. No nursing research reviews exist in this area. The authors conducted a systematic review on designs of clinical technology, 34 articles with 50 studies met inclusion criteria. Findings were classified into three categories based on HF research goals. The majority of studies evaluated effectiveness of clinical design; efficiency was fewest. Current research ranges across many interface types examined with no apparent pattern or obvious rationale. Future research should expand types, settings, participants; integrate displays; and expand outcome variables. PMID:19707093

Horizon 2020 Priorities in Clinical Mental Health Research: Results of a Consensus-Based ROAMER Expert Survey

PubMed Central

Elfeddali, Iman; van der Feltz-Cornelis, Christina M.; van Os, Jim; Knappe, Susanne; Vieta, Eduard; Wittchen, Hans-Ulrich; Obradors-Tarragó, Carla; Haro, Josep Maria

2014-01-01

Within the ROAMER project, which aims to provide a Roadmap for Mental Health Research in Europe, a two-stage Delphi survey among 86 European experts was conducted in order to identify research priorities in clinical mental health research. Expert consensus existed with regard to the importance of three challenges in the field of clinical mental health research: (1) the development of new, safe and effective interventions for mental disorders; (2) understanding the mechanisms of disease in order to be able to develop such new interventions; and (3) defining outcomes (an improved set of outcomes, including alternative outcomes) to use for clinical mental health research evaluation. Proposed actions involved increasing the utilization of tailored approaches (personalized medicine), developing blended eHealth/mHealth decision aids/guidance tools that help the clinician to choose between various treatment modalities, developing specific treatments in order to better target comorbidity and (further) development of biological, psychological and psychopharmacological interventions. The experts indicated that addressing these priorities will result in increased efficacy and impact across Europe; with a high probability of success, given that Europe has important strengths, such as skilled academics and a long research history. Finally, the experts stressed the importance of creating funding and coordinated networking as essential action needed in order to target the variety of challenges in clinical mental health research. PMID:25337940

Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol.

PubMed

Moller, David R; Koth, Laura L; Maier, Lisa A; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K; Collman, Ronald G; Hamzeh, Nabeel; Sweiss, Nadera J; Zhang, Yingze; O'Neal, Scott; Senior, Robert M; Becich, Michael; Hochheiser, Harry S; Kaminski, Naftali; Wisniewski, Stephen R; Gibson, Kevin F

2015-10-01

Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis.

Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol

PubMed Central

Koth, Laura L.; Maier, Lisa A.; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K.; Collman, Ronald G.; Hamzeh, Nabeel; Sweiss, Nadera J.; Zhang, Yingze; O’Neal, Scott; Senior, Robert M.; Becich, Michael; Hochheiser, Harry S.; Kaminski, Naftali; Wisniewski, Stephen R.; Gibson, Kevin F.

2015-01-01

Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant’s clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis. PMID:26193069

Health Disparities and Health Equity: The Issue Is Justice

PubMed Central

Kumanyika, Shiriki; Fielding, Jonathan; LaVeist, Thomas; Borrell, Luisa N.; Manderscheid, Ron; Troutman, Adewale

2011-01-01

Eliminating health disparities is a Healthy People goal. Given the diverse and sometimes broad definitions of health disparities commonly used, a subcommittee convened by the Secretary's Advisory Committee for Healthy People 2020 proposed an operational definition for use in developing objectives and targets, determining resource allocation priorities, and assessing progress. Based on that subcommittee's work, we propose that health disparities are systematic, plausibly avoidable health differences adversely affecting socially disadvantaged groups; they may reflect social disadvantage, but causality need not be established. This definition, grounded in ethical and human rights principles, focuses on the subset of health differences reflecting social injustice, distinguishing health disparities from other health differences also warranting concerted attention, and from health differences in general. We explain the definition, its underlying concepts, the challenges it addresses, and the rationale for applying it to United States public health policy. PMID:21551385

The Potential Influence of the Microbiota and Probiotics on Women during Long Spaceflights

PubMed Central

Urbaniak, Camilla; Reid, Gregor

2016-01-01

Humans have been exploring space for almost 55 years but space travel comes with many psychological and physiological changes that astronauts have to adapt to, both during and post flight missions. Now, with the reality of such missions lasting years, maintaining proper health of the flight crew is a high priority. While conditions such as nausea, bone loss, renal calculi and depression have been recognized, and approaches to medical and surgical care in space considered, the influence of the microbiota could be of added significance in maintaining astronaut health. While probiotics have long been part of the Russian cosmonaut diet, their use for specific health concerns of women has not been assessed. In this article, we explore the ways in which the microbiome may influence the health of female astronauts during long space flights, and present a rationale for the use of probiotics. PMID:26901697

Fun Science: The Use of Variable Manipulation to Avoid Content Instruction

NASA Astrophysics Data System (ADS)

Peters-Burton, Erin E.; Hiller, Suzanne E.

2013-02-01

This study examined the beliefs and rationale pre-service elementary teachers used to choose activities for upper-elementary students in a 1-week intensive science camp. Six undergraduate elementary pre-service teachers were observed as they took a semester-long science methods class that culminated in a 1-week science camp. This qualitative, phenomenological study found that counselors chose activities with the possibility of fun being a priority rather than teaching content, even after they were confronted with campers who demanded more content. Additionally, all six of the counselors agreed that activities involving variable manipulation were the most successful, even though content knowledge was not required to complete the activities. The counselors felt the variable manipulation activities were successful because students were constructing products and therefore getting to the end of the activity. Implications include building an awareness of the complexity of self-efficacy of science teaching and outcome expectancy to improve teacher education programs.

Food taxation and pricing strategies to "thin out" the obesity epidemic.

PubMed

Kim, Daniel; Kawachi, Ichiro

2006-05-01

This article highlights characteristics of two related yet distinct economic approaches to addressing the current obesity epidemic in the United States: the general taxation of soft drinks, snack foods, and/or fast foods, and the application of pricing incentives/disincentives on foods sold in schools and worksites. The article specifically focuses on the: (1) rationale for, (2) potential barriers and limitations to, and (3) possible unintended consequences of implementing these policy interventions at the state level. Novel empirical evidence showing strong positive associations between the presence of state-level taxation on soft drinks or snack foods between 1991 and 1998 and relative changes in obesity prevalence over the same time period is further presented. The article concludes by summarizing the similarities and dissimilarities of the two approaches, and by emphasizing some of the gaps and priorities regarding these strategies that should be addressed in future research and policies to best effect obesity prevention.

Reducing Health Disparities: The Role of Sleep Deficiency and Sleep Disorders

PubMed Central

Van Cauter, Eve; Diez-Roux, Ana V.

2015-01-01

Decrements in sleep health, including insufficient sleep duration, irregular timing of sleep, poor sleep quality, and sleep/circadian disorders are wide-spread in modern society and are associated with an array of disease risks and outcomes, including those contributing to health disparities (e.g. cardiovascular disease, obesity and diabetes, psychiatric illness and cancer). Recent findings have uncovered racial/ethnic and socioeconomic position differences in sleep health, however the contribution of sleep deficiency to health disparities remains largely unexplored, and understanding the underlying causes of disparities in sleep health is only beginning to emerge. In 2011, the National Heart Lung and Blood Institute convened a workshop, bringing together sleep and health disparities investigators, to identify research gaps and opportunities to advance sleep and health disparities science. This article provides a brief background and rationale for the workshop, and disseminates the research recommendations and priorities resulting from the working group discussions. PMID:26431756

Cancer Treatment–Related Cardiotoxicity: Current State of Knowledge and Future Research Priorities

PubMed Central

Adhikari, Bishow; Brell, Joanna; Davis, Myrtle; Desvigne-Nickens, Patrice; Freedman, Andrew; Minasian, Lori; Force, Thomas; Remick, Scot C.

2014-01-01

Cardiotoxicity resulting from direct myocyte damage has been a known complication of cancer treatment for decades. More recently, the emergence of hypertension as a clinically significant side effect of several new agents has been recognized as adversely affecting cancer treatment outcomes. With cancer patients living longer, in part because of treatment advances, these adverse events have become increasingly important to address. However, little is known about the cardiovascular pathogenic mechanisms associated with cancer treatment and even less about how to optimally prevent and manage short- and long-term cardiovascular complications, leading to improved patient safety and clinical outcomes. To identify research priorities, allocate resources, and establish infrastructure required to address cardiotoxicity associated with cancer treatment, the National Cancer Institute (NCI) and National Heart, Lung and Blood Institute (NHLBI) sponsored a two-day workshop, “Cancer treatment–related cardiotoxicity: Understanding the current state of knowledge and future research priorities,” in March 2013 in Bethesda, MD. Participants included leading oncology and cardiology researchers and health professionals, patient advocates and industry representatives, with expertise ranging from basic to clinical science. Attendees were charged with identifying research opportunities to advance the understanding of cancer treatment–related cardiotoxicity across basic and clinical science. This commentary highlights the key discussion points and overarching recommendations from that workshop. PMID:25210198

Challenges of T3 and T4 Translational Research

ERIC Educational Resources Information Center

Vukotich, Charles J., Jr.

2016-01-01

Translational research is a new and important way of thinking about research. It is a major priority of the National Institutes of Health (NIH) in the United States. NIH has created the Clinical and Translational Science Awards to promote this priority. NIH has defined T1 and T2 phases of translational research in the medical field, in order to…

Getting Paid for Clinical Services.

PubMed

Martin, Caren McHenry

2018-05-01

Increasingly, pharmacists are providing advanced, patient-centered clinical services. However, pharmacists are not currently included in key sections of the Social Security Act, which determines eligibility to bill and be reimbursed by Medicare. Many state and private health plans also cite the omission from Medicare as the rationale for excluding reimbursement of pharmacists for clinical services. This has prompted forward-thinking pharmacists to seek opportunities for reimbursement in other ways, allowing them to provide value to the health care system, while carving out unique niches for pharmacists to care for patients.

Research priorities for respiratory nursing: a UK-wide Delphi study.

PubMed

Kelly, Carol Ann; Kirkcaldy, Andrew J; Pilkington, Melissa; Hodson, Matthew; Welch, Lindsay; Yorke, Janelle; Knighting, Katherine

2018-04-01

Respiratory nurses make a significant contribution to the delivery of respiratory healthcare, but there is a dearth of nurse-led, practice-focused, published research. Using a modified three-round Delphi, this study sought to identify research priorities for respiratory nursing to inform a national research strategy. Study information and the survey link were sent electronically to members of UK professional respiratory organisations. Round 1 had 78 items across 16 topics, informed by a systematic literature review. Respondents suggested additional items which were content analysed to inform Round 2. Respondents rated all items and ranked the topics in all rounds. To ensure rigour, rounds had an explicit focus with pre-determined criteria for consensus (70%). In total, 363 responses were received across Rounds 1, 2 and 3 (n=183, 95 and 85, respectively). The top five research priorities were: 1) "Patient understanding of asthma control"; 2) "The clinical and cost-effectiveness of respiratory nurse interventions"; 3) "The impact of nurse-led clinics on patient care"; 4) "Inhaler technique"; and 5) two topics jointly scored: "Prevention of exacerbations" and "Symptom management". With potential international significance, this is the first UK study to identify research priorities for respiratory nursing, providing direction for those planning or undertaking research.

Research priorities for nursing and midwifery in Southern Ireland.

PubMed

McCarthy, G; Savage, E; Lehane, E

2006-06-01

To identify research priorities for nursing and midwifery in the Southern Health Board area in Ireland for the immediate and long term. Ten focus groups were conducted over a 2-month period with 70 nurses and midwives working in clinical, managerial and educational roles participating. Based on focus group findings and a literature review a multi-item Likert type questionnaire was constructed and administered to 520 nurses and midwives (response rate 95%n=494). Research priorities were identified as: (1) impact of staff shortages on retention of RNs/RM's (80%); (2) quality of life of chronically ill patients (76%); (3) stress and bullying in the workplace (76%); (4) assessment and management of pain (75%); (5) skill mix and staff burnout (73%); (6) cardio-pulmonary resuscitation decision making (72%); (7) coordination of care between hospital and primary care settings (69%); (8) medication errors (67%); and (9) promoting healthy lifestyles (64%). Respondents also indicated that these priorities warranted immediate attention. Implications for practice include the need for: (1) emphasis on quality pain control; (2) recognition and exploration of the ethical issues relating to resuscitation; and (3) management of the context within which clinical care is given.

Determining research priorities for adolescent and young adult cancer in Australia.

PubMed

Medlow, S; Patterson, P

2015-07-01

The Australian Youth Cancer Service (YCS) is part of a growing international movement to provide advocacy and better targeted health-care services for adolescents and young adults (AYAs) with cancer. One of the key initiatives of the YCS is to determine and implement priorities within Australian AYA cancer research. The YCS used the value-weighting online survey technique of allocating 100 hypothetical units of funding across pre-determined topics of research in order to determine Australian consumers' and health professionals' AYA cancer research priorities. A total of 101 participants (26 consumers and 75 health professionals) took part in the online survey. Biomedical and Clinical Medicine Research was allocated the greatest proportion of available funding. A number of priority populations were also identified, although these were distributed across pre-treatment and post-treatment stages. The preferences of consumers and health professionals to invest available AYA cancer research funds in Biomedical and Clinical Medicine Research will be an important consideration in guiding the Australian YCS decision-making process in the immediate future. 'Prevention, screening and early detection' was also an important research funding target, along with survivorship populations. © 2015 John Wiley & Sons Ltd.

Critical Care Specialty Elective: Nursing 401A.

ERIC Educational Resources Information Center

Jepson, Cheri A.

This course guide describes an elective speciality course on critical/intensive care nursing. A rationale for the course is followed by general information, including a description of the theoretical and clinical course components, an enumeration of major goals and objectives, a detailed outline of the units of instruction, a calendar of…

Wholistic Health Care for a Campus Student Health Service.

ERIC Educational Resources Information Center

Van Ness, John H.

1981-01-01

Discusses the importance of environmental and emotional considerations in medical care. Outlines the basic principles of holistic health care and provides a rationale for a campus-based center. Describes an existing holistic student health service and proposes a basic program for a campus holistic health clinic. (RC)

Tooth extraction by orthodontic force after radiation therapy: report of case

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

Rodu, B.; Filler, S.J.; Woodfin, G.K.

1985-12-01

This report presents a therapeutic approach to orthodontic tooth extraction in a patient at high risk for the development of osteoradionecrosis with conventional techniques. The rationale for this procedure is discussed in detail, combining principles of radiation biology, clinical radiation therapy, and biomechanics of tooth movement.

Components of Culture in Health for Medical Students' Education.

ERIC Educational Resources Information Center

Tervalon, Melanie

2003-01-01

Describes key themes and components of culture in health care for incorporation into undergraduate medical education. These include teaching the rationale for learning about culture in health care; "culture basics"; data on and concepts of health status; tools and skills for productive cross-cultural clinical encounters; characteristics and…

Wife-Battering: A Theoretical Construct and Case Report.

ERIC Educational Resources Information Center

Guerney, Bernard, Jr.; And Others

1987-01-01

Presents a theoretical construct (prostrate-detonate-dominate-ingratiate) to explain the development and maintenance of wife-battering. Ties the construct to research evidence and, along with clinical observations, uses it to develop a rationale for a type of therapy deemed effective with wife-batters: group marital Relationship Enhancement.…

[The use of eurespal for the treatment of chronic laryngitis].

PubMed

Riabova, M A

2011-01-01

The author provides a rationale for the use of eurespal for the treatment of chronic laryngitis based on the pathogenetic concept of pathological condition. The results of a clinical study designed to evaluate the efficiency and safety of eurespal therapy in patients with chronic laryngitis are presented.

Asthma and Respiratory Related Emergency Room Visits Associated with a Wildfire in Eastern North Carolina in the Summer of 2008

EPA Science Inventory

Rationale: Epidemiological studies have shown associations between the incidence of increased emergency room admissions, hospital and outpatient clinic visits for respiratory causes with the exposures to wood stove, wildfires, and other forms of organic mass burning. In June 2008...

Curriculum for Community Health Workers.

ERIC Educational Resources Information Center

Southwick, Paula S.

The Community Outreach Curriculum described in this paper is designed to prepare community health aides employed through the Outreach Department of Pima County (Arizona) Indian Health Inc., (PCIHI), which consists of two medical clinics on two separate reservations. The first sections of the paper describe PCIHI, provide a rationale for the…

Bupropion-SR plus naltrexone-SR for the treatment of mild-to-moderate obesity.

PubMed

Ali, Khawla F; Shukla, Alpana P; Aronne, Louis J

2016-01-01

Naltrexone-bupropion is a recently approved drug combination for chronic weight management. In this article, we discuss the rationale for its use as a combination followed by a comprehensive review of safety and efficacy data from major preclinical, phase II and III clinical trials.

Writing about Clients: Developing Composite Case Material and Its Rationale

ERIC Educational Resources Information Center

Duffy, Maureen

2010-01-01

Ethical guidelines of the 4 major professional associations representing counselors and psychotherapists are reviewed. To help clarify thinking about writing up clinical cases, 3 kinds of cases are described. The author concludes that the current guidelines for clinician authors in writing about clients for publication or presentation are…

Revised Risk Priority Number in Failure Mode and Effects Analysis Model from the Perspective of Healthcare System

PubMed Central

Rezaei, Fatemeh; Yarmohammadian, Mohmmad H.; Haghshenas, Abbas; Fallah, Ali; Ferdosi, Masoud

2018-01-01

Background: Methodology of Failure Mode and Effects Analysis (FMEA) is known as an important risk assessment tool and accreditation requirement by many organizations. For prioritizing failures, the index of “risk priority number (RPN)” is used, especially for its ease and subjective evaluations of occurrence, the severity and the detectability of each failure. In this study, we have tried to apply FMEA model more compatible with health-care systems by redefining RPN index to be closer to reality. Methods: We used a quantitative and qualitative approach in this research. In the qualitative domain, focused groups discussion was used to collect data. A quantitative approach was used to calculate RPN score. Results: We have studied patient's journey in surgery ward from holding area to the operating room. The highest priority failures determined based on (1) defining inclusion criteria as severity of incident (clinical effect, claim consequence, waste of time and financial loss), occurrence of incident (time - unit occurrence and degree of exposure to risk) and preventability (degree of preventability and defensive barriers) then, (2) risks priority criteria quantified by using RPN index (361 for the highest rate failure). The ability of improved RPN scores reassessed by root cause analysis showed some variations. Conclusions: We concluded that standard criteria should be developed inconsistent with clinical linguistic and special scientific fields. Therefore, cooperation and partnership of technical and clinical groups are necessary to modify these models. PMID:29441184

[National and regional prioritisation in Swedish health care: experiences from cardiology].

PubMed

Carlsson, Jörg

2012-01-01

Prioritisation of medical services in Sweden takes place on two different levels. On the national level, the Swedish priority guidelines ascribe priority values ranging from 1 (high priority) to 10 (low priority) to measures (in terms of condition-treatment pairs) of prevention, diagnosis, treatment and rehabilitation of cardiovascular diseases. In addition, this list contains interventions that should be avoided and those that should only be provided as part of clinical research projects. The government then commissions a multi-professional team under the supervision of the National Board of Health and Welfare "Socialstyelsen" with the development of corresponding guidelines. In addition to the scientific evidence, the priority lists incorporate ethical and economical aspects and are based on the so-called ethics platform consisting of human dignity, needs, solidarity and cost-effectiveness. At the other level of prioritisation there are regional projects aiming at the in- and exclusion of medical measures. The Swedish prioritisation process will be described using the example of priority lists in cardiology. (As supplied by publisher). Copyright © 2012. Published by Elsevier GmbH.

Perspectives of Patients, Caregivers and Researchers on Research Priorities in Donation and Transplantation in Canada: A Pilot Workshop

PubMed Central

Allard, Julie; Durand, Céline; Anthony, Samantha J.; Dumez, Vincent; Hartell, David; Hébert, Marie-Josée; West, Lori J.; Wright, Linda; Fortin, Marie-Chantal

2017-01-01

Background It is vitally important to seek input from key stakeholders to increase the quality and relevance of health-related research and accelerate its adoption into practice. Patients and caregivers have rarely been involved in setting research priorities in the transplantation and donation field. The objectives of this explorative study are: (i) to discuss research priorities within the Canadian National Transplant Research Program during a priority-setting exercise with patients, caregivers, organ donors and researchers and (ii) to compare the identified priorities with research published in 2 prestigious transplantation journals. Methods A pilot workshop attended by 10 patients and caregivers and 5 researchers was held in Montréal (Quebec, Canada) in August 2014 to identify research priorities. Priorities were identified using a thematic analysis of the workshop transcription conducted by multiple coders. These priorities were compared with the topics of research articles published in 2 major transplantation journals between 2012 and 2014. Results The themes of the 10 research priorities identified by study participants were related to different research domains: social, cultural, and environmental health factors (4); biomedical or clinical (4); and research about health systems and services (2). 26.7% of the research articles published were related to the identified priorities. Thirteen percent looked at ways to improve graft survival and 8.5% looked at the development of tolerance, 2 priorities identified by participants. Fewer than 5% examined the other 8 research priorities identified as important by workshop participants. Conclusions This is the first study reporting patients' and researchers' priorities in the field of transplantation and donation in Canada. There is a discrepancy between topics that key stakeholders find important and research published in 2 major transplantation journals. The research priorities identified during our initial workshop will be validated through a national survey and workshop. PMID:28361111

Increasing hope by addressing clients' outcome expectations.

PubMed

Swift, Joshua K; Derthick, Annie O

2013-09-01

Addressing clients' outcome expectations is an important clinical process that can lead to a strong therapeutic alliance, more positive treatment outcomes, and decreased rates of premature termination from psychotherapy. Five interventions designed to foster appropriate outcome expectations are discussed, including presenting a convincing treatment rationale, increasing clients' faith in their therapists, expressing faith in clients, providing outcome education, and comparing progress with expectations. Clinical examples and research support are provided for each. 2013 APA, all rights reserved

Clinical Validation Trial of a Diagnostic for Ebola Zaire Antigen Detection: Design Rationale and Challenges to Implementation

PubMed Central

Schieffelin, John; Moses, Lina M; Shaffer, Jeffrey; Goba, Augustine; Grant, Donald S

2015-01-01

The current Ebola outbreak in West Africa has affected more people than all previous outbreaks combined. The current diagnostic method of choice, quantitative polymerase chain reaction, requires specialized conditions as well as specially trained technicians. Insufficient testing capacity has extended the time from sample collection to results. These delays have led to further delays in the transfer and treatment to Ebola Treatment Units. A sensitive and specific point-of-care device that could be used reliably in low resource settings by healthcare workers with minimal training would increase the efficiency of triage and appropriate transfer of care. This article describes a study designed to validate the sensitivity and specificity of the ReEBOVTM RDT using venous whole blood and capillary blood obtained via fingerprick. We present the scientific and clinical rationale for the decisions made in the design of a diagnostic validation study to be conducted in an outbreak setting. The multi-site strategy greatly complicated implementation. In addition, a decrease in cases in one geographic area along with a concomitant increase in other areas made site selection challenging. Initiation of clinical trials during rapidly evolving outbreaks requires significant cooperation on a national level between research teams implementing studies and clinical care providers. Coordination and streamlining of approval process is essential if trials are to be implemented in a timely fashion. PMID:26768566

Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial.

PubMed

Schwartz, Robert P; Kelly, Sharon M; Mitchell, Shannon G; Dunlap, Laura; Zarkin, Gary A; Sharma, Anjalee; O'Grady, Kevin E; Jaffe, Jerome H

2016-07-01

Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. We describe the background and rationale for the study, its aims, hypotheses, and study design. Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. ClinicalTrials.gov: NCT02334215. Copyright © 2016 Elsevier Inc. All rights reserved.

Rationale and design of the Sodium Lowering In Dialysate (SoLID) trial: a randomised controlled trial of low versus standard dialysate sodium concentration during hemodialysis for regression of left ventricular mass

PubMed Central

2013-01-01

Background The current literature recognises that left ventricular hypertrophy makes a key contribution to the high rate of premature cardiovascular mortality in dialysis patients. Determining how we might intervene to ameliorate left ventricular hypertrophy in dialysis populations has become a research priority. Reducing sodium exposure through lower dialysate sodium may be a promising intervention in this regard. However there is clinical equipoise around this intervention because the benefit has not yet been demonstrated in a robust prospective clinical trial, and several observational studies have suggested sodium lowering interventions may be deleterious in some dialysis patients. Methods/design The Sodium Lowering in Dialysate (SoLID) study is funded by the Health Research Council of New Zealand. It is a multi-centre, prospective, randomised, single-blind (outcomes assessor), controlled parallel assignment 3-year clinical trial. The SoLID study is designed to study what impact low dialysate sodium has upon cardiovascular risk in dialysis patients. The study intends to enrol 118 home hemodialysis patients from 6 sites in New Zealand over 24 months and follow up each participant over 12 months. Key exclusion criteria are: patients who dialyse more frequently than 3.5 times per week, pre-dialysis serum sodium of <135 mM, and maintenance hemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials, which contraindicate the SoLID study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will be dialysed using dialysate sodium 135 mM and 140 mM respectively, for 12 months. The primary outcome measure is left ventricular mass index, as measured by cardiac magnetic resonance imaging, after 12 months of intervention. Eleven or more secondary outcomes will be studied in an attempt to better understand the physiologic and clinical mechanisms by which lower dialysate sodium alters the primary end point. Discussion The SoLID study is designed to clarify the effect of low dialysate sodium upon the cardiovascular outcomes of dialysis patients. The study results will provide much needed information about the efficacy of a cost effective, economically sustainable solution to a condition which is curtailing the lives of so many dialysis patients. Trial registration Australian and New Zealand Clinical Trials Registry number: ACTRN12611000975998 PMID:23855560

Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy in TYpe 2 diabetic patients with normoalbuminuria (PRIORITY): essential study design and rationale of a randomised clinical multicentre trial.

PubMed

Lindhardt, Morten; Persson, Frederik; Currie, Gemma; Pontillo, Claudia; Beige, Joachim; Delles, Christian; von der Leyen, Heiko; Mischak, Harald; Navis, Gerjan; Noutsou, Marina; Ortiz, Alberto; Ruggenenti, Piero Luigi; Rychlik, Ivan; Spasovski, Goce; Rossing, Peter

2016-03-02

Diabetes mellitus affects 9% of the European population and accounts for 15% of healthcare expenditure, in particular, due to excess costs related to complications. Clinical trials aiming for earlier prevention of diabetic nephropathy by renin angiotensin system blocking treatment in normoalbumuric patients have given mixed results. This might reflect that the large fraction of normoalbuminuric patients are not at risk of progression, thereby reducing power in previous studies. A specific risk classifier based on urinary proteomics (chronic kidney disease (CKD)273) has been shown to identify normoalbuminuric diabetic patients who later progressed to overt kidney disease, and may hold the potential for selection of high-risk patients for early intervention. Combining the ability of CKD273 to identify patients at highest risk of progression with prescription of preventive aldosterone blockade only to this high-risk population will increase power. We aim to confirm performance of CKD273 in a prospective multicentre clinical trial and test the ability of spironolactone to delay progression of early diabetic nephropathy. Investigator-initiated, prospective multicentre clinical trial, with randomised double-masked placebo-controlled intervention and a prospective observational study. We aim to include 3280 type 2 diabetic participants with normoalbuminuria. The CKD273 classifier will be assessed in all participants. Participants with high-risk pattern are randomised to treatment with spironolactone 25 mg once daily, or placebo, whereas, those with low-risk pattern will be observed without intervention other than standard of care. Treatment or observational period is 3 years.The primary endpoint is development of confirmed microalbuminuria in 2 of 3 first morning voids urine samples. The study will be conducted under International Conference on Harmonisation - Good clinical practice (ICH-GCP) requirements, ethical principles of Declaration of Helsinki and national laws. This first new biomarker-directed intervention trial aiming at primary prevention of diabetic nephropathy may pave the way for personalised medicine approaches in treatment of diabetes complications. NCT02040441; Pre-results. 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/

A cluster randomized trial of a transition intervention for adolescents with congenital heart disease: rationale and design of the CHAPTER 2 study.

PubMed

Mackie, Andrew S; Rempel, Gwen R; Kovacs, Adrienne H; Kaufman, Miriam; Rankin, Kathryn N; Jelen, Ahlexxi; Manlhiot, Cedric; Anthony, Samantha J; Magill-Evans, Joyce; Nicholas, David; Sananes, Renee; Oechslin, Erwin; Dragieva, Dimi; Mustafa, Sonila; Williams, Elina; Schuh, Michelle; McCrindle, Brian W

2016-06-06

The population of adolescents and young adults with congenital heart disease (CHD) is growing exponentially. These survivors are at risk of late cardiac complications and require lifelong cardiology care. However, there is a paucity of data on how to prepare adolescents to assume responsibility for their health and function within the adult health care system. Evidence-based transition strategies are required. The Congenital Heart Adolescents Participating in Transition Evaluation Research (CHAPTER 2) Study is a two-site cluster randomized clinical trial designed to evaluate the efficacy of a nurse-led transition intervention for 16-17 year olds with moderate or complex CHD. The primary endpoint is excess time to adult CHD care, defined as the time interval between the final pediatric cardiology appointment and the first adult CHD appointment, minus the recommended time interval between these appointments. Secondary endpoints include the MyHeart score (CHD knowledge), Transition Readiness Assessment Questionnaire score, and need for catheter or surgical re-intervention. Participants are enrolled in clusters based on week of attendance in the pediatric cardiology clinic. The intervention consists of two one-hour individualized sessions between a cardiology nurse and study participant. Session One focuses on knowledge of the participant's CHD, review of their cardiac anatomy and prior interventions, and potential late cardiac complications. Session Two focuses on self-management and communication skills through review and discussion of videos and role-play. The study will recruit 120 participants. Many adolescents and young adults experience a gap in care predisposing them to late cardiac complications. The CHAPTER 2 Study will investigate the impact of a nurse-led transition intervention among adolescents with CHD. Fidelity of the intervention is a major focus and priority. This study will build on our experience by (i) enrolling at two tertiary care programs, (ii) including a self-management intervention component, and (iii) evaluating the impact of the intervention on time to ACHD care, a clinically relevant outcome. The results of this study will inform pediatric cardiology programs, patients and policy makers in judging whether a structured intervention program provides clinically meaningful outcomes for adolescents and young adults living with CHD. ClinicalTrials.gov ID NCT01723332.

Clinical use of quantitative cardiac perfusion PET: rationale, modalities and possible indications. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM).

PubMed

Sciagrà, Roberto; Passeri, Alessandro; Bucerius, Jan; Verberne, Hein J; Slart, Riemer H J A; Lindner, Oliver; Gimelli, Alessia; Hyafil, Fabien; Agostini, Denis; Übleis, Christopher; Hacker, Marcus

2016-07-01

Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice.

The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke.

PubMed

Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

2016-01-01

The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients.

Rationale, Timeline, Study Design, and Protocol Overview of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials

PubMed Central

Moler, Frank W.; Silverstein, Faye S.; Meert, Kathleen L.; Clark, Amy E.; Holubkov, Richard; Browning, Brittan; Slomine, Beth S.; Christensen, James R.; Dean, Michael

2014-01-01

Objective To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design Multicenter randomized controlled trials. Setting Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials. PMID:23842585

Clinical Utility and "DSM-V"

ERIC Educational Resources Information Center

Mullins-Sweatt, Stephanie N.; Widiger, Thomas A.

2009-01-01

The construction of the American Psychiatric Association's diagnostic manual has been guided primarily by concerns of construct validity rather than of clinical utility, despite claims by its authors that the highest priority has in fact been clinical utility. The purpose of this article was to further articulate the concept and importance of…

National Priority Setting of Clinical Practice Guidelines Development for Chronic Disease Management.

PubMed

Jo, Heui-Sug; Kim, Dong Ik; Oh, Moo-Kyung

2015-12-01

By November 2013, a total of 125 clinical practice guidelines (CPGs) have been developed in Korea. However, despite the high burden of diseases and the clinical importance of CPGs, most chronic diseases do not have available CPGs. Merely 83 CPGs are related to chronic diseases, and only 40 guidelines had been developed in the last 5 yr. Considering the rate of the production of new evidence in medicine and the worsening burden from chronic diseases, the need for developing CPGs for more chronic diseases is becoming increasingly pressing. Since 2011, the Korean Academy of Medical Sciences and the Korea Centers for Disease Control and Prevention have been jointly developing CPGs for chronic diseases. However, priorities have to be set and resources need to be allocated within the constraint of a limited funding. This study identifies the chronic diseases that should be prioritized for the development of CPGs in Korea. Through an objective assessment by using the analytic hierarchy process and a subjective assessment with a survey of expert opinion, high priorities were placed on ischemic heart disease, cerebrovascular diseases, Alzheimer's disease and other dementias, osteoarthritis, neck pain, chronic kidney disease, and cirrhosis of the liver.

Factors explaining priority setting at community mental health centres: a quantitative analysis of referral assessments.

PubMed

Grepperud, Sverre; Holman, Per Arne; Wangen, Knut Reidar

2014-12-14

Clinicians at Norwegian community mental health centres assess referrals from general practitioners and classify them into three priority groups (high priority, low priority, and refusal) according to need where need is defined by three prioritization criteria (severity, effect, and cost-effectiveness). In this study, we seek to operationalize the three criteria and analyze to what extent they have an effect on clinical-level priority setting after controlling for clinician characteristics and organisational factors. Twenty anonymous referrals were rated by 42 admission team members employed at 14 community mental health centres in the South-East Health Region of Norway. Intra-class correlation coefficients were calculated and logistic regressions were performed. Variation in clinicians' assessments of the three criteria was highest for effect and cost-effectiveness. An ordered logistic regression model showed that all three criteria for prioritization, three clinician characteristics (education, being a manager or not, and "guideline awareness"), and the centres themselves (fixed effects), explained priority decisions. The relative importance of the explanatory factors, however, depended on the priority decision studied. For the classification of all admitted patients into high- and low-priority groups, all clinician characteristics became insignificant. For the classification of patients, into those admitted and non-admitted, one criterion (effect) and "being a manager or not" became insignificant, while profession ("being a psychiatrist") became significant. Our findings suggest that variation in priority decisions can be reduced by: (i) reducing the disagreement in clinicians' assessments of cost-effectiveness and effect, and (ii) restricting priority decisions to clinicians with a similar background (education, being a manager or not, and "guideline awareness").

[The Danish Debate on Priority Setting in Medicine--An Update].

PubMed

Pornak, S C; Raspe, H

2015-09-01

In the last years, the Danish debate about priority setting in medicine has gained new strength. This paper shows the main focuses of the current discussion based on a research of Danish primary literature. For the first time since the 1990s the Danish Council of Ethics has been involved with priority setting in medicine in a project running from 2011 to 2013. The Council emphasises the importance of legitimate processes and calls for visible values and criteria. A focus of the debate is how to deal with new expensive drugs. Politicians, physicians, health economists and the Council of Ethics have called for a national institution for priority setting in medicine. They have mainly looked to the Norwegian National Council for Priority Setting in Health Care and the British National Institute for Health and Care Excellence for inspiration. The Danish Government considered establishing a national institute for priority setting, but the plans were not put into practice. In the year 2012 a new national project was launched to create clinical guidelines. Danish doctors welcome the guidelines as a good basis for priority setting. Just like in earlier Danish priority setting debates, a coordinating institution is lacking to bundle the discussion and keep it going. The debate seems to have come to an end once again. The fact that it was seriously considered to establish an institute for priority setting is a new development. It can be expected that the discussion will be resumed in the near future, possibly the idea of an institute for priority setting will be readopted. The general conditions for priority setting in health care have improved. © Georg Thieme Verlag KG Stuttgart · New York.

MsFLASH participants' priorities for alleviating menopausal symptoms.

PubMed

Carpenter, J S; Woods, N F; Otte, J L; Guthrie, K A; Hohensee, C; Newton, K M; Joffe, H; Cohen, L; Sternfeld, B; Lau, R J; Reed, S D; LaCroix, A Z

2015-01-01

To describe self-reported menopausal symptom priorities and their association with demographics and other symptoms among participants in an intervention trial for vasomotor symptoms (VMS). Cross-sectional study embedded in the MsFLASH 02 trial, a three-by-two factorial design of yoga vs. exercise vs. usual activity and omega-3-fatty acid vs. placebo. At baseline, women (n = 354) completed hot flush diaries, a card sort task to prioritize symptoms they would most like to alleviate, and standardized questionnaires. The most common symptom priorities were: VMS (n = 322), sleep (n = 191), concentration (n = 140), and fatigue (n = 116). In multivariate models, women who chose VMS as their top priority symptom (n = 210) reported significantly greater VMS severity (p = 0.004) and never smoking (p = 0.012), and women who chose sleep as their top priority symptom (n = 100) were more educated (p ≤ 0.001) and had worse sleep quality (p < 0.001). ROC curves identified sleep scale scores that were highly predictive of ranking sleep as a top priority symptom. Among women entering an intervention trial for VMS and with relatively low prevalence of depression and anxiety, VMS was the priority symptom for treatment. A card sort may be a valid tool for quickly assessing symptom priorities in clinical practice and research.

Relevance of Donepezil in Enhancing Learning and Memory in Special Populations: A Review of the Literature

ERIC Educational Resources Information Center

Yoo, J. Helen; Valdovinos, Maria G.; Williams, Dean C.

2007-01-01

This review discusses the laboratory and clinical research supporting the rationale for the efficacy of donepezil (Aricept[R] USA) in enhancing cognition in autism, Alzheimer disease, Down syndrome, traumatic brain injury, Attention Deficit Hyperactivity Disorder (ADHD), and schizophrenia. While preliminary animal models have shown effective,…

Preparing School Counseling Students to Aid Families: Integrating a Family Systems Perspective

ERIC Educational Resources Information Center

Paylo, Matthew John

2011-01-01

In this article, the value of integrating family systems theory into a school counseling curriculum is explored. Some programs have historically placed school counselors in a difficult position by not adequately preparing them for the demands of incorporating family systems and community collaboration into clinical practice. The rationale for…

Rat Models of Cardiometabolic Diseases: Baseline Clinical Chemistries, and Rationale for their Use in Examining Air Pollution Health Effects

EPA Science Inventory

This is the first of a series of 8 papers examining susceptibility of various rodent cardiometabolic disease models to ozone induced health effects. Individuals with cardiovascular and metabolic diseases (CVD) are shown to be more susceptible to adverse health effects o...

Diagnosing and Managing Violence

PubMed Central

2011-01-01

Available categorization systems for violence encountered in medical practice do not constitute optimal tools to guide management. In this article, 4 common patterns of violence across psychiatric diagnoses are described (defensive, dominance-defining, impulsive, and calculated) and management implications are considered. The phenomenologic and neurobiological rationale for a clinical classification system of violence is also presented. PMID:22295257

Building and Managing Your Private Practice.

ERIC Educational Resources Information Center

Richards, Daniel L.

The number of clinicians entering private practice is growing each day. This book presents a step-by-step process for prospective entrepreneurs who wish to become a private practitioner. The text is divided into eight sections. Section 1 looks at the rationale for private practice and addresses the personal questions involving clinical skills,…

The Harvard/Brown Anxiety Research Project-Phase II (HARP-II): rationale, methods, and features of the sample at intake.

PubMed

Weisberg, Risa B; Beard, Courtney; Dyck, Ingrid; Keller, Martin B

2012-05-01

We describe the rationale, method, and intake demographic and clinical findings of the Harvard/Brown Anxiety Research Project-Phase II (HARP-II). HARP-II is the first prospective, observational, longitudinal study to describe the characteristics and course of anxiety in African American, Latino, and Non-Latino White individuals. Participants met criteria for at least one of the following disorders: Generalized Anxiety Disorder, Social Phobia, Panic Disorder with or without Agoraphobia, Agoraphobia without history of Panic Disorder, Post-traumatic Stress Disorder. Initial intake data, collected between 2004 and 2011, are presented for 165 African American, 150 Latino, and 172 Non-Latino White participants. Participants evidenced substantial psychiatric comorbidity (mean number of Axis I disorders=3.4), and moderate to severe symptoms and functional impairment. HARP-II will examine clinical course, in the context of potential socio-cultural and individual moderators (e.g., discrimination, acculturation, negative affect). Results should lead to improved understanding, prognostics, and treatment of anxiety in diverse populations. Copyright © 2012 Elsevier Ltd. All rights reserved.

The "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study: Rationale, design and methods.

PubMed

Calvani, Riccardo; Picca, Anna; Marini, Federico; Biancolillo, Alessandra; Cesari, Matteo; Pesce, Vito; Lezza, Angela Maria Serena; Bossola, Maurizio; Leeuwenburgh, Christiaan; Bernabei, Roberto; Landi, Francesco; Marzetti, Emanuele

2018-05-10

Sarcopenia, the progressive and generalised loss of muscle mass and strength/function, is a major health issue in older adults given its high prevalence and burdensome clinical implications. Over the years, this condition has been endorsed as a marker for discriminating biological from chronological age. However, the absence of a unified operational definition has hampered its full appreciation by healthcare providers, researchers and policy-makers. In addition to this unsolved debate, the complexity of musculoskeletal ageing represents a major challenge to the identification of clinically meaningful biomarkers. Here, we illustrate the advantages of biomarker discovery procedures in muscle ageing based on multivariate methodologies as an alternative approach to traditional single-marker strategies. The rationale, design and methods of the "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study are described as an application of a multi-marker strategy for the development of biomarkers for the newly operationalised Physical Frailty & Sarcopenia condition. Copyright © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

In utero stem cell transplantation and gene therapy: rationale, history, and recent advances toward clinical application

PubMed Central

Almeida-Porada, Graça; Atala, Anthony; Porada, Christopher D

2016-01-01

Recent advances in high-throughput molecular testing have made it possible to diagnose most genetic disorders relatively early in gestation with minimal risk to the fetus. These advances should soon allow widespread prenatal screening for the majority of human genetic diseases, opening the door to the possibility of treatment/correction prior to birth. In addition to the obvious psychological and financial benefits of curing a disease in utero, and thereby enabling the birth of a healthy infant, there are multiple biological advantages unique to fetal development, which provide compelling rationale for performing potentially curative treatments, such as stem cell transplantation or gene therapy, prior to birth. Herein, we briefly review the fields of in utero transplantation (IUTx) and in utero gene therapy and discuss the biological hurdles that have thus far restricted success of IUTx to patients with immunodeficiencies. We then highlight several recent experimental breakthroughs in immunology, hematopoietic/marrow ontogeny, and in utero cell delivery, which have collectively provided means of overcoming these barriers, thus setting the stage for clinical application of these highly promising therapies in the near future. PMID:27069953

How accurate are orthopedic surgeons in diagnosing periprosthetic joint infection after total knee arthroplasty?: A multicenter study.

PubMed

Koh, In Jun; Cho, Woo-Shin; Choi, Nam Yong; Parvizi, Javad; Kim, Tae Kyun

2015-06-01

The lack of standardized diagnostic criteria for periprosthetic joint infection (PJI) poses a challenge to accurate diagnosis of PJI. Recently, the Musculoskeletal Infection Society (MSIS) proposed diagnostic criteria for PJI. However, it is not known how well these proposed criteria accommodate real clinical scenarios. We determined what proportion of patients satisfied the MSIS criteria, and if MSIS criteria were not met, what other rationales were used to diagnose PJI. We retrospectively reviewed the records of 303 patients who underwent two-stage exchange arthroplasty for treatment of PJI of the knee at 17 institutions. The rationale for making the diagnosis of PJI was also recorded, if the case did not meet the MSIS criteria. In addition, detailed information about isolated microorganisms were gathered. Among the 303 patients, 198 met the diagnostic criteria proposed by MSIS. Among the 105 patients who did not meet the MSIS criteria, 88% met two or three minor criteria; however joint fluid analysis or histologic analysis was not performed in 85% of these 105 patients. The most common rationale for the diagnosis of PJI was the presence of abnormal physical findings. Microorganisms were identified in only 52% of all patients; the most common organism was coagulase-negative Staphylococcus. The diagnosis of PJI was based on clinical suspicion in approximately one-third of cases. In this series, joint aspiration or histological analysis was not performed in a large number of patients. Thus, surgeons should perform joint fluid and histologic analysis to assure the accuracy of PJI diagnosis. Copyright © 2015 Elsevier B.V. All rights reserved.

To Report or Not to Report: Exploring Healthy Volunteers' Rationales for Disclosing Adverse Events in Phase I Drug Trials.

PubMed

McManus, Lisa; Fisher, Jill A

2018-04-25

Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants' self-reports of any symptoms they experience during the trial. In some cases, experiencing AEs can result in trial participation being terminated. Because of the economic incentives underlying their motivation to participate, there is concern that healthy volunteers routinely fail to report AEs and, thereby, jeopardize the validity of the trial results. We interviewed 131 U.S. healthy volunteers about their experiences with AEs, including their rationales for reporting or failing to report symptoms. We found that participants have three primary rationales for their AE reporting behavior: economic, health-oriented, and data integrity. Participants often make decisions about whether to report AEs on a case-by-case basis evaluating what effects reporting or not reporting might have on the compensation they receive from the trial, the risk to their health, and the results of the particular clinical trial. Participants' interpretations of clinic policies, staff behaviors, and personal or vicarious experiences with reporting AEs also shape reporting decisions. Our findings demonstrate that participants' reporting behavior is more complex than previous portraits of healthy volunteers have suggested. Rather than finding participants who were so focused on the financial compensation that they were willing to subvert trial results, our study indicates that participants are willing in most cases to forgo their full compensation if they believe not reporting their symptoms jeopardizes their own safety or the validity of the research.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part I - rationale and aims.

PubMed

Davis, Bruce H; Wood, Brent; Oldaker, Teri; Barnett, David

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part I - Rationale and aims. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

HIV and Alcohol Research Priorities of City, State, and Federal Policymakers: Results of a Delphi Study

PubMed Central

Li, Lingfeng; Braithwaite, Ronald Scott

2015-01-01

We identified the research areas related to HIV and alcohol consumption that were of highest priority to city, state, and federal policymakers. From June to July 2014, we conducted a 3-round Delphi study to elicit from experts a list of alcohol- and HIV-related clinical trial research questions that were important to fund and rank order the list to identify questions of highest priority. Translating evidence into practice must be improved because some questions that have been extensively studied with results published in peer-reviewed journals were identified by the panel as areas needing additional research. PMID:26180968

HIV and Alcohol Research Priorities of City, State, and Federal Policymakers: Results of a Delphi Study.

PubMed

Uyei, Jennifer; Li, Lingfeng; Braithwaite, Ronald Scott

2015-09-01

We identified the research areas related to HIV and alcohol consumption that were of highest priority to city, state, and federal policymakers. From June to July 2014, we conducted a 3-round Delphi study to elicit from experts a list of alcohol- and HIV-related clinical trial research questions that were important to fund and rank order the list to identify questions of highest priority. Translating evidence into practice must be improved because some questions that have been extensively studied with results published in peer-reviewed journals were identified by the panel as areas needing additional research.

Telotristat ethyl: proof of principle and the first oral agent in the management of well-differentiated metastatic neuroendocrine tumor and carcinoid syndrome diarrhea.

PubMed

Masab, Muhammad; Saif, Muhammad Wasif

2017-12-01

Metastatic neuroendocrine tumors (NETs) are associated with carcinoid syndrome that is typically characterized by diarrhea, cutaneous flushing and bronchospasm. Treatment with somatostatin analogues (SSA) improves the symptom burden but a significant proportion of patients stop responding to SSA therapy eventually. Novel agents with the potential to effectively control the symptoms are urgently needed. This article reviews an in-depth analysis of the phase I-III clinical trials determining the clinical rationale for the use of tryptophan hydroxylase inhibitor, telotristat ethyl in patients with well-differentiated metastatic NETs and uncontrolled carcinoid syndrome. Telotristat ethyl has already been approved for the treatment of inadequately controlled carcinoid syndrome symptoms in metastatic NET patients on SSA therapy. Results from multiple phase I-III clinical studies of telotristat ethyl therapy have reported a significant decrease in the daily bowel movement frequency, increase in quality of life and the subsequent decrease in annual health costs related to carcinoid syndrome symptoms in NET patients. The associated decrease in urinary 5-hydroxyindoleacetic acid (u5-HIAA) provides evidence that telotristat ethyl effectively decreases serotonin production, and therefore, offers a rationale to investigate this agent to mitigate serotonin-mediated complications in this patient population, especially cardiac valvular disease or mesenteric fibrosis.

Physical mechanism and modeling of heat generation and transfer in magnetic fluid hyperthermia through Néelian and Brownian relaxation: a review.

PubMed

Suriyanto; Ng, E Y K; Kumar, S D

2017-03-23

Current clinically accepted technologies for cancer treatment still have limitations which lead to the exploration of new therapeutic methods. Since the past few decades, the hyperthermia treatment has attracted the attention of investigators owing to its strong biological rationales in applying hyperthermia as a cancer treatment modality. Advancement of nanotechnology offers a potential new heating method for hyperthermia by using nanoparticles which is termed as magnetic fluid hyperthermia (MFH). In MFH, superparamagnetic nanoparticles dissipate heat through Néelian and Brownian relaxation in the presence of an alternating magnetic field. The heating power of these particles is dependent on particle properties and treatment settings. A number of pre-clinical and clinical trials were performed to test the feasibility of this novel treatment modality. There are still issues yet to be solved for the successful transition of this technology from bench to bedside. These issues include the planning, execution, monitoring and optimization of treatment. The modeling and simulation play crucial roles in solving some of these issues. Thus, this review paper provides a basic understanding of the fundamental and rationales of hyperthermia and recent development in the modeling and simulation applied to depict the heat generation and transfer phenomena in the MFH.

Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design.

PubMed

Liu, Liping; Wang, Yilong; Meng, Xia; Li, Na; Tan, Ying; Nie, Ximing; Liu, Dacheng; Zhao, Xingquan

2017-04-01

Rationale Acute intracerebral hemorrhage inflicts a high-economic and -health burden. Computed tomography angiography spot sign is a predictor of hematoma expansion, is associated with poor clinical outcome and is an important stratifying variable for patients treated with haemostatic therapy. Aims We aim to compare the effect of treatment with tranexamic acid to placebo for the prevention of hemorrhage growth in patients with high-risk acute intracerebral hemorrhage with a positive spot sign. Design The tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign (TRAIGE) is a prospective, multicenter, placebo-controlled, double-blind, investigator-led, randomized clinical trial that will include an estimated 240 participants. Patients with intracerebral hemorrhage demonstrating symptom onset within 8 h and with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy, will be enrolled to receive either tranexamic acid or placebo. The primary outcome measure is the presence of hemorrhage growth defined as an increase in intracerebral hemorrhage volume >33% or >6 ml from baseline to 24 ± 2 h. The secondary outcomes include safety and clinical outcomes. Conclusion The TRAIGE trial evaluates the efficacy of haemostatic therapy with tranexamic acid in the prevention of hemorrhage growth among high-risk patients with acute intracerebral hemorrhage.

Are two penicillins better than one? A systematic review of oral flucloxacillin and penicillin V versus oral flucloxacillin alone for the emergency department treatment of cellulitis.

PubMed

Quirke, Michael; O'Sullivan, Ronan; McCabe, Aileen; Ahmed, Jameel; Wakai, Abel

2014-06-01

Flucloxacillin either alone or combined with penicillin V is still the first-line antibiotic drug of choice for the treatment of cellulitis in emergency departments (EDs) in Ireland. The rationale for this antibiotic regimen is their anti-staphylococcal and anti-streptococcal activity. To determine the clinical efficacy, tolerability and safety of oral flucloxacillin alone (monotherapy) compared with a combination of flucloxacillin with penicillin V (dual therapy) in the ED-directed outpatient treatment of cellulitis. We searched the following electronic databases: MEDLINE (1950 to August 2011), EMBASE (1980 to August 2011), Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library 2011, Issue), OpenGrey, Current Controlled Trials metaRegister of Clinical Trials (August 2011) and reference lists and websites of potential trials. We performed cross-referencing from the reference lists of major articles on the subject. We imposed no language restriction. Despite a comprehensive literature search to identify relevant studies, no randomized-controlled trials that fulfilled the inclusion criteria were found. Despite its common use, there are no published randomized-controlled trials comparing flucloxacillin monotherapy with a combination of flucloxacillin and penicillin V in the ED management of cellulitis. We discuss existing European and North American prescribing rationale and current guidelines.

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

PubMed

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

2017-08-01

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

Incremental cost effectiveness evaluation in clinical research.

PubMed

Krummenauer, Frank; Landwehr, I

2005-01-28

The health economic evaluation of therapeutic and diagnostic strategies is of increasing importance in clinical research. Therefore also clinical trialists have to involve health economic aspects more frequently. However, whereas they are quite familiar with classical effect measures in clinical trials, the corresponding parameters in health economic evaluation of therapeutic and diagnostic procedures are still not this common. The concepts of incremental cost effectiveness ratios (ICERs) and incremental net health benefit (INHB) will be illustrated and contrasted along the cost effectiveness evaluation of cataract surgery with monofocal and multifocal intraocular lenses. ICERs relate the costs of a treatment to its clinical benefit in terms of a ratio expression (indexed as Euro per clinical benefit unit). Therefore ICERs can be directly compared to a pre-specified willingness to pay (WTP) benchmark, which represents the maximum costs, health insurers would invest to achieve one clinical benefit unit. INHBs estimate a treatment's net clinical benefit after accounting for its cost increase versus an established therapeutic standard. Resource allocation rules can be formulated by means of both effect measures. Both the ICER and the INHB approach enable the definition of directional resource allocation rules. The allocation decisions arising from these rules are identical, as long as the willingness to pay benchmark is fixed in advance. Therefore both strategies crucially call for a priori determination of both the underlying clinical benefit endpoint (such as gain in vision lines after cataract surgery or gain in quality-adjusted life years) and the corresponding willingness to pay benchmark. The use of incremental cost effectiveness and net health benefit estimates provides a rationale for health economic allocation discussions and founding decisions. It implies the same requirements on trial protocols as yet established for clinical trials, that is the a priori definition of primary hypotheses (formulated as an allocation rule involving a pre-specified willingness to pay benchmark) and the primary clinical benefit endpoint (as a rationale for effectiveness evaluation).

A Review and Proposed Rationale for the use of Ultrasonography as a Diagnostic Modality in the Identification of Bone Stress Injuries.

PubMed

Fukushima, Yaeko; Ray, Jeremiah; Kraus, Emily; Syrop, Isaac P; Fredericson, Michael

2018-04-14

Bone stress injuries are common in military personnel and athletes. The delayed diagnosis of a bone stress injury can lead to a more severe injury that requires a longer period of treatment. The early detection of bone stress injuries is a central part of management. Currently, the reference standard for detecting bone stress injuries is magnetic resonance imaging. However, the expanding use of point-of-care ultrasonography (US) may enable the early detection of bone stress injuries in the clinical setting. In this article, we review the US detection of bone stress injuries, as well as discuss the rationale for the use of US in the diagnosis of these injuries. © 2018 by the American Institute of Ultrasound in Medicine.

Cicada-inspired cell-instructive nanopatterned arrays

NASA Astrophysics Data System (ADS)

Diu, Ting; Faruqui, Nilofar; Sjöström, Terje; Lamarre, Baptiste; Jenkinson, Howard F.; Su, Bo; Ryadnov, Maxim G.

2014-11-01

Biocompatible surfaces hold key to a variety of biomedical problems that are directly related to the competition between host-tissue cell integration and bacterial colonisation. A saving solution to this is seen in the ability of cells to uniquely respond to physical cues on such surfaces thus prompting the search for cell-instructive nanoscale patterns. Here we introduce a generic rationale engineered into biocompatible, titanium, substrates to differentiate cell responses. The rationale is inspired by cicada wing surfaces that display bactericidal nanopillar patterns. The surfaces engineered in this study are titania (TiO2) nanowire arrays that are selectively bactericidal against motile bacteria, while capable of guiding mammalian cell proliferation according to the type of the array. The concept holds promise for clinically relevant materials capable of differential physico-mechanical responses to cellular adhesion.

Cicada-inspired cell-instructive nanopatterned arrays.

PubMed

Diu, Ting; Faruqui, Nilofar; Sjöström, Terje; Lamarre, Baptiste; Jenkinson, Howard F; Su, Bo; Ryadnov, Maxim G

2014-11-20

Biocompatible surfaces hold key to a variety of biomedical problems that are directly related to the competition between host-tissue cell integration and bacterial colonisation. A saving solution to this is seen in the ability of cells to uniquely respond to physical cues on such surfaces thus prompting the search for cell-instructive nanoscale patterns. Here we introduce a generic rationale engineered into biocompatible, titanium, substrates to differentiate cell responses. The rationale is inspired by cicada wing surfaces that display bactericidal nanopillar patterns. The surfaces engineered in this study are titania (TiO2) nanowire arrays that are selectively bactericidal against motile bacteria, while capable of guiding mammalian cell proliferation according to the type of the array. The concept holds promise for clinically relevant materials capable of differential physico-mechanical responses to cellular adhesion.

Strategy development to sustain and strengthen the Navy Nurse Corps.

PubMed

Raimondo, Lisa H; Pierce, Kathleen M; Bruzek-Kohler, Christine M

2008-01-01

This article demonstrates how the strategic planning process was utilized to determine organizational priorities for the Navy Nurse Corps amidst a time of ongoing conflicts in Iraq and professional duress resulting from the national nursing shortage. The authors denote how overarching organizational goals of the US Navy and Navy medicine are woven into the priorities that were established for Navy Nursing. The emerging 6 priorities are relevant and vital to the sustainment of Navy Nursing today and in the future. They reflect the challenges associated with the development of clinical proficiency, educational policies, force structure/recruitment and retention, mid-grade and senior leadership roles, productivity measurement, and organizational communication. Similarly, these priorities mirror those that confront and warrant the attention of chief nursing officers in the civilian sector as they lead and develop their workforce.

Iliotibial band friction syndrome

PubMed Central

2010-01-01

Published articles on iliotibial band friction syndrome have been reviewed. These articles cover the epidemiology, etiology, anatomy, pathology, prevention, and treatment of the condition. This article describes (1) the various etiological models that have been proposed to explain iliotibial band friction syndrome; (2) some of the imaging methods, research studies, and clinical experiences that support or call into question these various models; (3) commonly proposed treatment methods for iliotibial band friction syndrome; and (4) the rationale behind these methods and the clinical outcome studies that support their efficacy. PMID:21063495

Managing competing organizational priorities in clinical handover across organizational boundaries.

PubMed

Sujan, Mark A; Chessum, Peter; Rudd, Michelle; Fitton, Laurence; Inada-Kim, Matthew; Cooke, Matthew W; Spurgeon, Peter

2015-01-01

Handover across care boundaries poses additional challenges due to the different professional, organizational and cultural backgrounds of the participants involved. This paper provides a qualitative account of how practitioners in emergency care attempt to align their different individual and organizational priorities and backgrounds when handing over patients across care boundaries (ambulance service to emergency department (ED), and ED to acute medicine). A total of 270 clinical handovers were observed in three emergency care pathways involving five participating NHS organizations (two ambulance services and three hospitals). Half-day process mapping sessions were conducted for each pathway. Semi-structured interviews were carried out with 39 participants and analysed thematically. The management of patient flow and the fulfilment of time-related performance targets can create conflicting priorities for practitioners during handover. Practitioners involved in handover manage such competing organizational priorities through additional coordination effort and dynamic trade-offs. Practitioners perceive greater collaboration across departments and organizations, and mutual awareness of each other's goals and constraints as possible ways towards more sustainable improvement. Sustainable improvement in handover across boundaries in emergency care might require commitment by leaders from all parts of the local health economy to work as partners to establish a culture of integrated, patient-centred care. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Research priorities for respiratory nursing: a UK-wide Delphi study

PubMed Central

Pilkington, Melissa; Hodson, Matthew; Welch, Lindsay; Yorke, Janelle

2018-01-01

Respiratory nurses make a significant contribution to the delivery of respiratory healthcare, but there is a dearth of nurse-led, practice-focused, published research. Using a modified three-round Delphi, this study sought to identify research priorities for respiratory nursing to inform a national research strategy. Study information and the survey link were sent electronically to members of UK professional respiratory organisations. Round 1 had 78 items across 16 topics, informed by a systematic literature review. Respondents suggested additional items which were content analysed to inform Round 2. Respondents rated all items and ranked the topics in all rounds. To ensure rigour, rounds had an explicit focus with pre-determined criteria for consensus (70%). In total, 363 responses were received across Rounds 1, 2 and 3 (n=183, 95 and 85, respectively). The top five research priorities were: 1) “Patient understanding of asthma control”; 2) “The clinical and cost-effectiveness of respiratory nurse interventions”; 3) “The impact of nurse-led clinics on patient care”; 4) “Inhaler technique”; and 5) two topics jointly scored: “Prevention of exacerbations” and “Symptom management”. With potential international significance, this is the first UK study to identify research priorities for respiratory nursing, providing direction for those planning or undertaking research. PMID:29692999

Problems in counting and paying for multidisciplinary outpatient clinics.

PubMed

Jackson, T; Sevil, P

1997-01-01

Policy-makers have always found it problematic to formulate fair and consistent counting rules for public hospital outpatient activities. In the context of output-based funding, such rules have consequences which can affect patient care. This paper reviews the rationale for organising multidisciplinary clinics and reports on a series of focus groups convened in four Melbourne teaching hospitals to consider funding policy for such clinics. It discusses issues of targeting outpatient services, along with implications for payment policy. It evaluates counting rules in terms of intended and unintended consequences in the context of Victoria's introduction of output-based funding for outpatient services.

Identifying the educational needs of nursing staff: the role of the clinical nurse specialist in perinatal nursing.

PubMed

Millhaem, Toni Brown; Timm, Kathleen

2007-01-01

One of the priorities of the perinatal clinical nurse specialist is the identification of educational needs. This article describes the experience of 2 perinatal clinical nurse specialists and presents various methods for identifying the educational needs of perinatal nursing staff in the hospital setting.

National Rules for Drug–Drug Interactions: Are They Appropriate for Tertiary Hospitals?

PubMed Central

2016-01-01

The application of appropriate rules for drug–drug interactions (DDIs) could substantially reduce the number of adverse drug events. However, current implementations of such rules in tertiary hospitals are problematic as physicians are receiving too many alerts, causing high override rates and alert fatigue. We investigated the potential impact of Korean national DDI rules in a drug utilization review program in terms of their severity coverage and the clinical efficiency of how physicians respond to them. Using lists of high-priority DDIs developed with the support of the U.S. government, we evaluated 706 contraindicated DDI pairs released in May 2015. We evaluated clinical log data from one tertiary hospital and prescription data from two other tertiary hospitals. The measured parameters were national DDI rule coverage for high-priority DDIs, alert override rate, and number of prescription pairs. The coverage rates of national DDI rules were 80% and 3.0% at the class and drug levels, respectively. The analysis of the system log data showed an overall override rate of 79.6%. Only 0.3% of all of the alerts (n = 66) were high-priority DDI rules. These showed a lower override rate of 51.5%, which was much lower than for the overall DDI rules. We also found 342 and 80 unmatched high-priority DDI pairs which were absent in national rules in inpatient orders from the other two hospitals. The national DDI rules are not complete in terms of their coverage of severe DDIs. They also lack clinical efficiency in tertiary settings, suggesting improved systematic approaches are needed. PMID:27822925

Is there a rationale for pulmonary rehabilitation following successful chemotherapy for tuberculosis?

PubMed Central

Muñoz-Torrico, Marcela; Rendon, Adrian; Centis, Rosella; D'Ambrosio, Lia; Fuentes, Zhenia; Torres-Duque, Carlos; Mello, Fernanda; Dalcolmo, Margareth; Pérez-Padilla, Rogelio; Spanevello, Antonio; Migliori, Giovanni Battista

2016-01-01

ABSTRACT The role of tuberculosis as a public health care priority and the availability of diagnostic tools to evaluate functional status (spirometry, plethysmography, and DLCO determination), arterial blood gases, capacity to perform exercise, lesions (chest X-ray and CT), and quality of life justify the effort to consider what needs to be done when patients have completed their treatment. To our knowledge, no review has ever evaluated this topic in a comprehensive manner. Our objective was to review the available evidence on this topic and draw conclusions regarding the future role of the "post-tuberculosis treatment" phase, which will potentially affect several million cases every year. We carried out a non-systematic literature review based on a PubMed search using specific keywords (various combinations of the terms "tuberculosis", "rehabilitation", "multidrug-resistant tuberculosis", "pulmonary disease", "obstructive lung disease", and "lung volume measurements"). The reference lists of the most important studies were retrieved in order to improve the sensitivity of the search. Manuscripts written in English, Spanish, and Russian were selected. The main areas of interest were tuberculosis sequelae following tuberculosis diagnosis and treatment; "destroyed lung"; functional evaluation of sequelae; pulmonary rehabilitation interventions (physiotherapy, long-term oxygen therapy, and ventilation); and multidrug-resistant tuberculosis.The evidence found suggests that tuberculosis is definitively responsible for functional sequelae, primarily causing an obstructive pattern on spirometry (but also restrictive and mixed patterns), and that there is a rationale for pulmonary rehabilitation. We also provide a list of variables that should be discussed in future studies on pulmonary rehabilitation in patients with post-tuberculosis sequelae. PMID:27812638

Barriers and benefits associated with nurses information seeking related to patient education needs on clinical nursing units.

PubMed

Jones, Josette; Schilling, Katherine; Pesut, Daniel

2011-01-01

The purpose of this study was to answer the following two questions: What are clinical nurses' rationales for their approaches to finding patient educational materials on the web? What are perceived barriers and benefits associated with the use of web-based information resources for patient education in the context of nursing clinical practice?Over 179 individual data units were analyzed to understand clinical nurses' rationales for their approaches to find patient educational materials on the web. Rationales were defined as those underlying catalysts or activators leading to an information need. Analyses found that the primary reasons why clinical nurses conducted web-based information searches included direct patient requests ( 9 requests), colleague requests (6 requests), building patient materials collections (4), patients' family requests (3), routine teaching (1), personal development (1), or staff development (1). From these data, four broad themes emerged: professional reasons, personal reasons, technology reasons, and organization reasons for selecting information resources. Content analysis identified 306 individual data units representing either 'benefits' (178 units) or 'barriers' (128) to the nurses' use of web resources for on-unit patient care. Inter-rater reliability was assessed and found to be excellent (r = 0.943 to 0.961). The primary themes that emerged as barriers to the used of web-based resources included: 1) time requirements to perform a search, 2) nurses' experience and knowledge about the resources or required technology, 3) specific characteristics of individuals electronic information resources, and 4) organizational procedures and policies. Three primary themes that represented the benefits of using web-based resources were also identified: 1) past experiences and knowledge of a specific resource or the required technologies, 2) availability and accessibility on the unit, and 3) specific characteristics of individual information tool. In many cases, nurses commented on specific characteristics or features of favorite information resources. Favorite sites included a variety or reputable health care organizations that displayed context in text, audio, and/or video. In addition such sites were described as easy-to read and provided content related to patient-focused information or specific content such as toll free telephone contact numbers.Information searching is the interaction between and among information users and computer-based information systems. Information seeking is becoming an important part of the knowledge work of nurses. Information seeking and searching intersects with the field of human computer interaction (HCI), which focuses on all aspects of human, and computer interactions. Users of an information system are understood as "actors" in situations, with a set of skills and shared practices based on work experiences with others. Designing better tools and developing information searching strategies that support, extend, and transform practices, begins by asking: Who are the users? What are the tasks? What is the interplay between the technology and the organization of the task? This study contributes fundamental data and information about the rationales nurses use in information seeking tasks. In addition it provides empirical evidences regarding barriers and benefits of information seeking in the context of patient education needs in inpatient clinical settings.

Neural Mechanisms of Cognitive-Behavioral Therapy for Aggression in Children and Adolescents: Design of a Randomized Controlled Trial Within the National Institute for Mental Health Research Domain Criteria Construct of Frustrative Non-Reward

PubMed Central

Wyk, Brent C. Vander; Eilbott, Jeffrey A.; McCauley, Spencer A.; Ibrahim, Karim; Crowley, Michael J.; Pelphrey, Kevin A.

2016-01-01

Abstract Objective: We present the rationale and design of a randomized controlled trial of cognitive-behavioral therapy (CBT) for aggression in children and adolescents, which is conducted in response to the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) approach initiative. Specifically, the study is focused on the brain-behavior associations within the RDoC construct of frustrative non-reward. On the behavioral level, this construct is defined by reactions elicited in response to withdrawal or prevention of reward, most notably reactive aggression. This study is designed to test the functional magnetic resonance (fMRI) and electrophysiological (EEG) correlates of aggression and its reduction after CBT. Methods: Eighty children and adolescents with high levels of aggression across multiple traditional diagnostic categories, ages 8–16, will be randomly assigned to receive 12 sessions of CBT or 12 sessions of supportive psychotherapy. Clinical outcomes will be measured by the ratings of aggressive behavior collected at baseline, midpoint, and endpoint evaluations, and by the Improvement Score of the Clinical Global Impressions Scale assigned by an independent evaluator (blinded rater). Subjects will also perform a frustration-induction Go-NoGo task and a task of emotional face perception during fMRI scanning and EEG recording at baseline and endpoint. Results: Consistent with the NIMH strategic research priorities, if functional neuroimaging and EEG variables can identify subjects who respond to CBT for aggression, this can provide a neuroscience-based classification scheme that will improve treatment outcomes for children and adolescents with aggressive behavior. Conclusions: Demonstrating that a change in the key nodes of the emotion regulation circuitry is associated with a reduction of reactive aggression will provide evidence to support the validity of the frustrative non-reward construct. PMID:26784537

Biosciences in nurse education: is the curriculum fit for practice? Lecturers' views and recommendations from across the UK.

PubMed

Taylor, Vanessa; Ashelford, Sarah; Fell, Patricia; Goacher, Penelope J

2015-10-01

This study aims to review the biosciences component of preregistration nursing programmes in higher education institutions across the UK through the experiences and perceptions of lecturers involved in nursing education. Studies suggest that some qualified nurses lack confidence in explaining the bio-scientific rationale for their clinical practice. Biosciences can be difficult to understand and integrate into clinical decision-making and require protected time within preregistration nurse education. In the absence of explicit national guidelines, it is unclear as to the depth and extent biosciences are taught across different institutions and the level achieved at the point of registration. A survey approach was adopted to generate quantitative and qualitative feedback. Data were collected using a semi-structured questionnaire seeking the experiences and views of lecturers involved in teaching biosciences to nursing students across the UK. Data received from 10 institutions were analysed using descriptive statistics and thematic analysis. Lecturers reported that the hours of taught biosciences ranged from 20-113 hours, principally within the first year. This represents between 0·4-2·4% of time within a preregistration nursing programme (4600 hours). Large group lectures predominate, supplemented by smaller group or practical work, and online materials. The biosciences are assessed specifically in half the institutions surveyed and as part of integrated assessments in the rest. In relation to student feedback, all respondents stated that students consistently requested more time and greater priority for biosciences in their programme. This survey suggests that the number of hours spent teaching biosciences is minimal and varies widely between higher education institutions. All respondents expressed concern about the challenges of teaching difficult bio-scientific concepts to large groups in such a limited time and called for greater clarity in national guidelines to ensure that all nurses are adequately educated and assessed in bioscience subjects. Failure to understand the biosciences underpinning care has implications for safe and competent nursing. © 2015 John Wiley & Sons Ltd.

Inactivated- or killed-virus HIV/AIDS vaccines.

PubMed

Sheppard, Haynes W

2005-06-01

Inactivated or "killed" virus (KV) is a "classical" approach that has produced safe and effective human and veterinary vaccines but has received relatively little attention in the effort to develop an HIV/AIDS vaccine. Initially, KV and rgp120 subunit vaccines were the two most obvious approaches but, unfortunately, rgp120 has not been efficacious and the KV approach has been limited by a variety of scientific, technical, and sociological factors. For example, when responses to cellular antigens, present on SIV grown in human cells, proved to be largely responsible for efficacy, the KV approach was widely discounted. Similarly, when lab-adapted HIV-1 appeared to lose envelope glycoprotein during preparation (not the case for primary isolates), this was viewed as a fundamental barrier to the KV concept. Also, a preference for "safer", genetically-engineered vaccines, and emphasis on cellular immunity, have left KV low on the priority list for funding agencies and investigators. The recent suggestion that "native" trimeric gp120 displays conserved conformational neutralization epitopes, along with the failure of rgp120, and difficulties in raising strong cellular responses with DNA or vectored vaccines, has restored some interest in the KV concept. In the past 15 years, several groups have initiated pre-clinical development of KV candidates for SIV or HIV and promising, albeit limited, information has been produced. In this chapter we discuss the rationale (including pros and cons) for producing and testing killed-HIV vaccines, the prospects for success, the nature and scope of research needed to test the KV concept, what has been learned to date, and what remains undone.

A perspective on "cure" for Rett syndrome.

PubMed

Clarke, Angus John; Abdala Sheikh, Ana Paula

2018-04-02

The reversal of the Rett syndrome disease process in the Mecp2 mouse model of Guy et al. (2007) has motivated families and researchers to work on this condition. The reversibility in adult mice suggests that there is potentially much to be gained from rational treatments applied to patients of any age. However, it may be difficult to strike the right balance between enthusiasm on the one hand and realism on the other. One effect of this has been a fragmentation of the "Rett syndrome community" with some groups giving priority to work aimed at a cure while fewer resources are devoted to medical or therapy-based interventions to enhance the quality of life of affected patients or provide support for their families.Several possible therapeutic approaches are under development that, it is claimed and hoped, may lead to a "cure" for patients with Rett syndrome. While all have a rationale, there are potential obstacles to each being both safe and effective. Furthermore, any strategy that succeeded in restoring normal levels of MECP2 gene expression throughout the brain carries potential pitfalls, so that it will be of crucial importance to introduce any clinical trials of such therapies with great care.Expectations of families for a radical, rational treatment should not be inflated beyond a cautious optimism. This is particularly because affected patients with us now may not be able to reap the full benefits of a "cure". Thus, interventions aimed at enhancing the quality of life of affected patients should not be forgone and their importance should not be minimised.

Selection of medicines in Chilean public hospitals: an exploratory study.

PubMed

Collao, Juan F; Smith, Felicity; Barber, Nick

2013-01-07

There is a growing interest in high income countries to control expenditure on medicines by improving the rationale for their selection. However, in middle income countries with differing priorities and needs, little attention has been paid to this issue. In this paper we explore the policies and processes for the selection and use of medicines in a group of hospitals in Chile, a middle income country which has recently joined the OECD. A combination of qualitative and quantitative methods was used. A national survey questionnaire was distributed to investigate the role and operation of PTCs (Pharmacy and Therapeutics Committees). Interviews were conducted with key actors in the selection of medicines in large urban public hospitals. The national survey had an overall response rate of 42% (83 out of 196), whilst 7 out of 14 hospitals participated in the qualitative study. High complexity hospitals are large urban hospitals; all of which claim to have a working PTC. The pharmacy offices are mainly involved in dispensing medicines with little involvement in clinical duties.The interviews conducted suggest that the formulary of all the hospitals visited is no more than a stock list. PTCs are unable to influence the prescribing practices of doctors. Members do not feel prepared to challenge the opinions of specialists requesting a certain drug, and decisions are based primarily on costs. The inclusion of medicines in the clinical practice of hospitals is as a result of doctors bypassing the PTC and requesting the purchase of exceptional items, some of which are included in the formulary if they are widely used. There is an urgent need to develop medicine policies in hospitals in Chile. The procedures used to purchase medicines need to be revised. Central guidance for PTCs could help ensure a more rational use of medicines. PTCs need to be empowered to design formularies which cover all the clinical needs of doctors, training members in the analysis of scientific evidence beyond their own specialities. An influential PTC can take the appropriate measures and design workable policies to enforce a cost effective-use of resources.

Selection of medicines in Chilean public hospitals: an exploratory study

PubMed Central

2013-01-01

Background There is a growing interest in high income countries to control expenditure on medicines by improving the rationale for their selection. However, in middle income countries with differing priorities and needs, little attention has been paid to this issue. In this paper we explore the policies and processes for the selection and use of medicines in a group of hospitals in Chile, a middle income country which has recently joined the OECD. Methods A combination of qualitative and quantitative methods was used. A national survey questionnaire was distributed to investigate the role and operation of PTCs (Pharmacy and Therapeutics Committees). Interviews were conducted with key actors in the selection of medicines in large urban public hospitals. Results The national survey had an overall response rate of 42% (83 out of 196), whilst 7 out of 14 hospitals participated in the qualitative study. High complexity hospitals are large urban hospitals; all of which claim to have a working PTC. The pharmacy offices are mainly involved in dispensing medicines with little involvement in clinical duties. The interviews conducted suggest that the formulary of all the hospitals visited is no more than a stock list. PTCs are unable to influence the prescribing practices of doctors. Members do not feel prepared to challenge the opinions of specialists requesting a certain drug, and decisions are based primarily on costs. The inclusion of medicines in the clinical practice of hospitals is as a result of doctors bypassing the PTC and requesting the purchase of exceptional items, some of which are included in the formulary if they are widely used. Conclusions There is an urgent need to develop medicine policies in hospitals in Chile. The procedures used to purchase medicines need to be revised. Central guidance for PTCs could help ensure a more rational use of medicines. PTCs need to be empowered to design formularies which cover all the clinical needs of doctors, training members in the analysis of scientific evidence beyond their own specialities. An influential PTC can take the appropriate measures and design workable policies to enforce a cost effective-use of resources. PMID:23294543

Use of mechanism-based structure-activity relationships analysis in carcinogenic potential ranking for drinking water disinfection by-products.

PubMed Central

Woo, Yin-Tak; Lai, David; McLain, Jennifer L; Manibusan, Mary Ko; Dellarco, Vicki

2002-01-01

Disinfection by-products (DBPs) are formed when disinfectants such as chlorine, chloramine, and ozone react with organic and inorganic matter in water. The observations that some DBPs such as trihalomethanes (THMs), di-/trichloroacetic acids, and 3-chloro-4-(dichloromethyl)-5-hydroxy-2(5H)-furanone (MX) are carcinogenic in animal studies have raised public concern over the possible adverse health effects of DBPs. To date, several hundred DBPs have been identified. To prioritize research efforts, an in-depth, mechanism-based structure-activity relationship analysis, supplemented by extensive literature search for genotoxicity and other data, was conducted for ranking the carcinogenic potential of DBPs that met the following criteria: a) detected in actual drinking water samples, b) have insufficient cancer bioassay data for risk assessment, and c) have structural features/alerts or short-term predictive assays indicative of carcinogenic potential. A semiquantitative concern rating scale of low, marginal, low-moderate, moderate, high-moderate, and high was used along with delineation of scientific rationale. Of the 209 DBPs analyzed, 20 were of priority concern with a moderate or high-moderate rating. Of these, four were structural analogs of MX and five were haloalkanes that presumably will be controlled by existing and future THM regulations. The other eleven DBPs, which included halonitriles (6), haloketones (2), haloaldehyde (1), halonitroalkane (1), and dialdehyde (1), are suitable priority candidates for future carcinogenicity testing and/or mechanistic studies. PMID:11834465

Merging with for-profits: flawed strategy. Such affiliations benefit neither the Catholic hospital nor society.

PubMed

Miller, A

1996-01-01

Some Catholic healthcare organizations, seeking new sources of capital, are eyeing mergers with for-profit systems. However, such mergers raise questions about their effects on both the mission of particular Catholic institutions and the well-being of society at large. For-profit organizations are driven by the pursuit of profit. They market ¿products.¿ This pursuit naturally shapes their decision-making rationales, employee relations, and business priorities. Not for-profits, on the other hand, provide ¿public goods¿--goods that for-profits either will not provide or will not provide adequately--and this mission shapes their priorities, decision making, and employee relations differently. What is more, economic power is unequal between the two kinds of organization. Since not-for profits are seeking capital when they merge with for profits, they usually do so from a position of relative disadvantage. When conflicts arise, the for-profit partner generally prevails. The not-for-profit partner then finds itself, not merged with, but acquired by the for-profit. Throughout U.S. history, not-for-profits have performed a function neglected by both government and private companies. Now, in the 1990s, the whole social welfare framework of our society is under attack. A moral-political crisis questions the very concept of the voluntary sector. If Catholic healthcare organizations allow themselves to be swallowed by for-profits, who will care for the voiceless and the vulnerable?

A review of mind-body therapies in the treatment of cardiovascular disease. Part 1: Implications for the elderly.

PubMed

Luskin, F M; Newell, K A; Griffith, M; Holmes, M; Telles, S; Marvasti, F F; Pelletier, K R; Haskell, W L

1998-05-01

A review of research on complementary and alternative treatments, specifically mind-body techniques, was conducted at Stanford University. The goals of the review were to establish a comprehensive literature review and to provide a rationale for future research concerning successful aging. Computerized searches were conducted using MEDLINE, PsychInfo, Stanford Library, Dissertation Abstracts, Lexus-Nexus, the Internet, and interviews conducted with practitioners. All studies since 1990 that examined mind-body treatments of cardiovascular disorders in the elderly were included. Mind-body practices evaluated were social support, cognitive-behavioral treatment, meditation, the placebo effect, hope, faith, imagery, spiritual healing, music therapy, hypnosis, yoga, t'ai chi, qigong and aikido. Studies conducted after 1990 were a priority, but when more recent literature was scarce, other studies using randomized, controlled trials were included. Mind-body techniques were found to be efficacious primarily as complementary and sometimes as stand-alone alternative treatments for cardiovascular disease-related conditions. Studies provided evidence for treatment efficacy, but the need for further controlled research was evident. Reviewers found only a handful of randomized, controlled research studies conducted in the United States. As a result, there is a lack of replicated studies with which to determine appropriate treatment dosage and the mechanisms by which many of the practices work. Compelling anecdotal evidence, the presence of some controlled research, overall cost effectiveness, and the lack of side effects resulting from mind-body treatments make further investigation a high priority.

TH-A-18A-01: Innovation in Clinical Breast Imaging

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

Liu, B; Yang, K; Yaffe, M

Several novel modalities have been or are on the verge of being introduced into the breast imaging clinic. These include tomosynthesis imaging, dedicated breast CT, contrast-enhanced digital mammography, and automated breast ultrasound, all of which are covered in this course. Tomosynthesis and dedicated breast CT address the problem of tissue superimposition that limits mammography screening performance, by improved or full resolution of the 3D breast morphology. Contrast-enhanced digital mammography provides functional information that allows for visualization of tumor angiogenesis. 3D breast ultrasound has high sensitivity for tumor detection in dense breasts, but the imaging exam was traditionally performed by radiologists.more » In automated breast ultrasound, the scan is performed in an automated fashion, making for a more practical imaging tool, that is now used as an adjunct to digital mammography in breast cancer screening. This course will provide medical physicists with an in-depth understanding of the imaging physics of each of these four novel imaging techniques, as well as the rationale and implementation of QC procedures. Further, basic clinical applications and work flow issues will be discussed. Learning Objectives: To be able to describe the underlying physical and physiological principles of each imaging technique, and to understand the corresponding imaging acquisition process. To be able to describe the critical system components and their performance requirements. To understand the rationale and implementation of quality control procedures, as well as regulatory requirements for systems with FDA approval. To learn about clinical applications and understand risks and benefits/strength and weakness of each modality in terms of clinical breast imaging.« less

An Introduction to Recursive Partitioning: Rationale, Application, and Characteristics of Classification and Regression Trees, Bagging, and Random Forests

ERIC Educational Resources Information Center

Strobl, Carolin; Malley, James; Tutz, Gerhard

2009-01-01

Recursive partitioning methods have become popular and widely used tools for nonparametric regression and classification in many scientific fields. Especially random forests, which can deal with large numbers of predictor variables even in the presence of complex interactions, have been applied successfully in genetics, clinical medicine, and…

Nuclear medicine in clinical urology and nephrology

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

Tauxe, W.N.; Dubousky, E.V.

This book presents explanations of current procedures involving the kidney with information of the performance of each test, its rationale, and interpretation. The information covers all currently used radiopharmaceuticals, radiation dosimetry, instrumentation, test protocols, and mathematical principles of pathophysiology as they relate to nuclear medicine studies. Information is provided on which radiopharmaceutical, instrument, or computer application to use, and when.

Skills for Social and Academic Success: A School-Based Intervention for Social Anxiety Disorder in Adolescents

ERIC Educational Resources Information Center

Fisher, Paige H.; Masia-Warner, Carrie; Klein, Rachel G.

2004-01-01

This paper describes Skills for Academic and Social Success (SASS), a cognitive-behavioral, school-based intervention for adolescents with social anxiety disorder. Clinic-based treatment studies for socially anxious youth are reviewed, and a strong rationale for transporting empirically-based interventions into schools, such as SASS, is provided.…

Brief Cognitive-Behavioral Therapy for Anxious Youth: The Inner Workings

ERIC Educational Resources Information Center

Beidas, Rinad S.; Mychailyszyn, Matthew P.; Podell, Jennifer L.; Kendall, Philip C.

2013-01-01

We provide a detailed description of the clinical application of brief cognitive-behavioral therapy (BCBT) for anxious youth. A rationale for the development of BCBT is presented, followed by a description and discussion of the 8 sessions of the treatment. Mike, a 7-year-old youth with anxiety disorders, is used to illustrate the inner workings of…

Review of the Literature Regarding Early Memories and Their Emerging Use in Projective Spiritual Assessment.

ERIC Educational Resources Information Center

Bustrum, Joy M.

This doctoral research seeks to demonstrate the clinical utility of early memories by reviewing the current literature and providing a rationale for extending this research into the spiritual arena by highlighting the lack of available projective spiritual measures. Specific areas covered include an overview of early memory theory, technique and…

Analysis of Nursing Clinical Decision Support Requests and Strategic Plan in a Large Academic Health System.

PubMed

Whalen, Kimberly; Bavuso, Karen; Bouyer-Ferullo, Sharon; Goldsmith, Denise; Fairbanks, Amanda; Gesner, Emily; Lagor, Charles; Collins, Sarah

2016-01-01

To understand requests for nursing Clinical Decision Support (CDS) interventions at a large integrated health system undergoing vendor-based EHR implementation. In addition, to establish a process to guide both short-term implementation and long-term strategic goals to meet nursing CDS needs. We conducted an environmental scan to understand current state of nursing CDS over three months. The environmental scan consisted of a literature review and an analysis of CDS requests received from across our health system. We identified existing high priority CDS and paper-based tools used in nursing practice at our health system that guide decision-making. A total of 46 nursing CDS requests were received. Fifty-six percent (n=26) were specific to a clinical specialty; 22 percent (n=10) were focused on facilitating clinical consults in the inpatient setting. "Risk Assessments/Risk Reduction/Promotion of Healthy Habits" (n=23) was the most requested High Priority Category received for nursing CDS. A continuum of types of nursing CDS needs emerged using the Data-Information-Knowledge-Wisdom Conceptual Framework: 1) facilitating data capture, 2) meeting information needs, 3) guiding knowledge-based decision making, and 4) exposing analytics for wisdom-based clinical interpretation by the nurse. Identifying and prioritizing paper-based tools that can be modified into electronic CDS is a challenge. CDS strategy is an evolving process that relies on close collaboration and engagement with clinical sites for short-term implementation and should be incorporated into a long-term strategic plan that can be optimized and achieved overtime. The Data-Information-Knowledge-Wisdom Conceptual Framework in conjunction with the High Priority Categories established may be a useful tool to guide a strategic approach for meeting short-term nursing CDS needs and aligning with the organizational strategic plan.

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation.

PubMed

van Es, Suzanne C; Venema, Clasina M; Glaudemans, Andor W J M; Lub-de Hooge, Marjolijn N; Elias, Sjoerd G; Boellaard, Ronald; Hospers, Geke A P; Schröder, Carolina P; de Vries, Elisabeth G E

2016-02-01

Molecular imaging with PET is a rapidly emerging technique. In breast cancer patients, more than 45 different PET tracers have been or are presently being tested. With a good rationale, after development of the tracer and proven feasibility, it is of interest to evaluate whether there is a potential meaningful role for the tracer in the clinical setting-such as in staging, in the (early) prediction of a treatment response, or in supporting drug choices. So far, only (18)F-FDG PET has been incorporated into breast cancer guidelines. For proof of the clinical relevance of tracers, especially for analysis in a multicenter setting, standardization of the technology and access to the novel PET tracer are required. However, resources for PET implementation research are limited. Therefore, next to randomized studies, novel approaches are required for proving the clinical value of PET tracers with the smallest possible number of patients. The aim of this review is to describe the process of the development of PET tracers and the level of evidence needed for the use of these tracers in breast cancer. Several breast cancer trials have been performed with the PET tracers (18)F-FDG, 3'-deoxy-3'-(18)F-fluorothymidine ((18)F-FLT), and (18)F-fluoroestradiol ((18)F-FES). We studied them to learn lessons for the implementation of novel tracers. After defining the gap between a good rationale for a tracer and implementation in the clinical setting, we propose solutions to fill the gap to try to bring more PET tracers to daily clinical practice. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Perioperative leadership: managing change with insights, priorities, and tools.

PubMed

Taylor, David L

2014-07-01

The personal leadership of the perioperative director is a critical factor in the success of any change management initiative. This article presents an approach to perioperative nursing leadership that addresses obstacles that prevent surgical departments from achieving high performance in clinical and financial outcomes. This leadership approach consists of specific insights, priorities, and tools: key insights include self-understanding of personal barriers to leadership and accuracy at understanding economic and strategic considerations related to the OR environment; key priorities include creating a customer-centered organization, focusing on process improvement, and concentrating on culture change; and key tools include using techniques (e.g., direct engagement, collaborative leadership) to align surgical organizations with leadership priorities and mitigate specific perioperative management risks. Included in this article is a leadership development plan for perioperative directors. Copyright © 2014 AORN, Inc. Published by Elsevier Inc. All rights reserved.

JAK2 inhibitor therapy in myeloproliferative disorders: rationale, preclinical studies and ongoing clinical trials.

PubMed

Pardanani, A

2008-01-01

The recent identification of somatic mutations such as JAK2V617F that deregulate Janus kinase (JAK)-signal transducer and activator of transcription signaling has spurred development of orally bioavailable small-molecule inhibitors that selectively target JAK2 kinase as an approach to pathogenesis-directed therapy of myeloproliferative disorders (MPD). In pre-clinical studies, these compounds inhibit JAK2V617F-mediated cell growth at nanomolar concentrations, and in vivo therapeutic efficacy has been demonstrated in mouse models of JAK2V617F-induced disease. In addition, ex vivo growth of progenitor cells from MPD patients harboring JAK2V617F or MPLW515L/K mutations is also potently inhibited. JAK2 inhibitors currently in clinical trials can be grouped into those designed to primarily target JAK2 kinase (JAK2-selective) and those originally developed for non-MPD indications, but that nevertheless have significant JAK2-inhibitory activity (non-JAK2 selective). This article discusses the rationale for using JAK2 inhibitors for the treatment of MPD, as well as relevant aspects of clinical trial development for these patients. For instance, which group of MPD patients is appropriate for initial Phase I studies? Should JAK2V617F-negative MPD patients be included in the initial studies? What are the likely consequences of 'off-target' JAK3 and wild-type JAK2 inhibition? How should treatment responses be monitored?

Toward a VA Women's Health Research Agenda: setting evidence-based priorities to improve the health and health care of women veterans.

PubMed

Yano, Elizabeth M; Bastian, Lori A; Frayne, Susan M; Howell, Alexandra L; Lipson, Linda R; McGlynn, Geraldine; Schnurr, Paula P; Seaver, Margaret R; Spungen, Ann M; Fihn, Stephan D

2006-03-01

The expansion of women in the military is reshaping the veteran population, with women now constituting the fastest growing segment of eligible VA health care users. In recognition of the changing demographics and special health care needs of women, the VA Office of Research & Development recently sponsored the first national VA Women's Health Research Agenda-setting conference to map research priorities to the needs of women veterans and position VA as a national leader in Women's Health Research. This paper summarizes the process and outcomes of this effort, outlining VA's research priorities for biomedical, clinical, rehabilitation, and health services research.

Toward a VA Women's Health Research Agenda: Setting Evidence-based Priorities to Improve the Health and Health Care of Women Veterans

PubMed Central

Yano, Elizabeth M; Bastian, Lori A; Frayne, Susan M; Howell, Alexandra L; Lipson, Linda R; McGlynn, Geraldine; Schnurr, Paula P; Seaver, Margaret R; Spungen, Ann M; Fihn, Stephan D

2006-01-01

The expansion of women in the military is reshaping the veteran population, with women now constituting the fastest growing segment of eligible VA health care users. In recognition of the changing demographics and special health care needs of women, the VA Office of Research & Development recently sponsored the first national VA Women's Health Research Agenda-setting conference to map research priorities to the needs of women veterans and position VA as a national leader in Women's Health Research. This paper summarizes the process and outcomes of this effort, outlining VA's research priorities for biomedical, clinical, rehabilitation, and health services research. PMID:16637953

The top 10 research priorities in cystic fibrosis developed by a partnership between people with CF and healthcare providers

PubMed Central

Rowbotham, Nicola J; Smith, Sherie; Leighton, Paul A; Rayner, Oli C; Gathercole, Katie; Elliott, Zoe C; Nash, Edward F; Daniels, Tracey; Duff, Alistair J A; Collins, Sarah; Chandran, Suja; Peaple, Ursula; Brownlee, Keith

2018-01-01

There remain many treatment uncertainties in cystic fibrosis (CF). With limited resources, research should focus on questions which are most important to the CF community. We conducted a James Lind Alliance Priority Setting Partnership in CF. Research questions were elicited and then prioritised in successive surveys. A workshop agreed the final top 10. Online methods avoided cross infection and widened participation. The elicitation survey had 482 respondents (1080 questions) and prioritisation survey 677 respondents. Participants were drawn equally from the patient and clinical communities globally. We have achieved a consensus on 10 research priorities which will be attractive to funders. PMID:28778919

Approaches to appropriate care delivery from a policy perspective: A case study of Australia, England and Switzerland.

PubMed

Robertson-Preidler, Joelle; Anstey, Matthew; Biller-Andorno, Nikola; Norrish, Alexandra

2017-07-01

Appropriateness is a conceptual way for health systems to balance Triple Aim priorities for improving population health, containing per capita cost, and improving the patient experience of care. Comparing system approaches to appropriate care delivery can help health systems establish priorities and facilitate appropriate care practices. We conceptualized system appropriateness by identifying policies that aim to achieve the Triple Aim and their consequent trade-offs for financing, clinical practice, and the individual patient. We used secondary data sources to compare the appropriate care approaches of Australia, England, and Switzerland according to financial, clinical, and individual appropriateness policies. Health system approaches to appropriate care delivery varied. England prioritizes public health, equity and efficiency at the expense of individual choice, while Switzerland focuses on individual patient preferences, but has higher per capita and out of pocket costs. Australia provides equity in public care access and private health care options that allows for more patient choice, with health care costs falling between the two. Integrating the Triple Aim into health system design and policy can facilitate appropriate care delivery at the system, clinical, and individual levels. Approaches will vary and require countries to negotiate and justify priorities and trade-offs within the context of thehealth system. Copyright © 2017 Elsevier B.V. All rights reserved.

Vision 2020 measures University of New Mexico's success by health of its state.

PubMed

Kaufman, Arthur; Roth, Paul B; Larson, Richard S; Ridenour, Nancy; Welage, Lynda S; Romero-Leggott, Valerie; Nkouaga, Carolina; Armitage, Karen; McKinney, Kara L

2015-01-01

The University of New Mexico Health Sciences Center (UNMHSC) adopted a new Vision to work with community partners to help New Mexico make more progress in health and health equity than any other state by 2020. UNMHSC recognized it would be more successful in meeting communities' health priorities if it better aligned its own educational, research, and clinical missions with their needs. National measures that compare states on the basis of health determinants and outcomes were adopted in 2013 as part of Vision 2020 target measures for gauging progress toward improved health and health care in New Mexico. The Vision focused the institution's resources on strengthening community capacity and responding to community priorities via pipeline education, workforce development programs, community-driven and community-focused research, and community-based clinical service innovations, such as telehealth and "health extension." Initiatives with the greatest impact often cut across institutional silos in colleges, departments, and programs, yielding measurable community health benefits. Community leaders also facilitated collaboration by enlisting University of New Mexico educational and clinical resources to better respond to their local priorities. Early progress in New Mexico's health outcomes measures and state health ranking is a promising sign of movement toward Vision 2020. Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Leveraging a Sturge-Weber Gene Discovery: An Agenda for Future Research.

PubMed

Comi, Anne M; Sahin, Mustafa; Hammill, Adrienne; Kaplan, Emma H; Juhász, Csaba; North, Paula; Ball, Karen L; Levin, Alex V; Cohen, Bernard; Morris, Jill; Lo, Warren; Roach, E Steve

2016-05-01

Sturge-Weber syndrome (SWS) is a vascular neurocutaneous disorder that results from a somatic mosaic mutation in GNAQ, which is also responsible for isolated port-wine birthmarks. Infants with SWS are born with a cutaneous capillary malformation (port-wine birthmark) of the forehead or upper eyelid which can signal an increased risk of brain and/or eye involvement prior to the onset of specific symptoms. This symptom-free interval represents a time when a targeted intervention could help to minimize the neurological and ophthalmologic manifestations of the disorder. This paper summarizes a 2015 SWS workshop in Bethesda, Maryland that was sponsored by the National Institutes of Health. Meeting attendees included a diverse group of clinical and translational researchers with a goal of establishing research priorities for the next few years. The initial portion of the meeting included a thorough review of the recent genetic discovery and what is known of the pathogenesis of SWS. Breakout sessions related to neurology, dermatology, and ophthalmology aimed to establish SWS research priorities in each field. Key priorities for future development include the need for clinical consensus guidelines, further work to develop a clinical trial network, improvement of tissue banking for research purposes, and the need for multiple animal and cell culture models of SWS. Copyright © 2016. Published by Elsevier Inc.

Can the Faculty Development Door Swing Both Ways? Science and Clinical Teaching in the 1990s.

ERIC Educational Resources Information Center

Tedesco, Lisa A.

1988-01-01

The relationship between clinical teaching and research in the basic sciences is discussed. The same energy expended to enhance clinical research will also efficiently build new curricula; ease the strains associated with assigning a priority to teaching or research; and serve to further science, teaching, and technology transfer. (MLW)

42 CFR 68a.12 - What will happen if an individual does not comply with the terms and conditions of participation...

Code of Federal Regulations, 2010 CFR

2010-10-01

... NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS FROM... approved clinical research. Similarly, the research needs and priorities of the ICA and/or the NIH may... utilized in a non-clinical research assignment. Under these circumstances, the following will apply: (i...

Clinical Problem Solving Exercises for Pre-Clinical Medical Education: A Design, Implementation and Preliminary Evaluation.

ERIC Educational Resources Information Center

Bordage, Georges

Clinical problem solving exercises for preclinical medical education that were developed at Michigan State University School of Osteopathic Medicine are described. Two types of outcomes were set as priorities in the design and implementation of the problem solving sessions: small group peer interactions as instructional and evaluative resources;…

Priority setting for health technology assessments: a systematic review of current practical approaches.

PubMed

Noorani, Hussein Z; Husereau, Donald R; Boudreau, Rhonda; Skidmore, Becky

2007-01-01

This study sought to identify and compare various practical and current approaches of health technology assessment (HTA) priority setting. A literature search was performed across PubMed, MEDLINE, EMBASE, BIOSIS, and Cochrane. Given an earlier review conducted by European agencies (EUR-ASSESS project), the search was limited to literature indexed from 1996 onward. We also searched Web sites of HTA agencies as well as HTAi and ISTAHC conference abstracts. Agency representatives were contacted for information about their priority-setting processes. Reports on practical approaches selected through these sources were identified independently by two reviewers. A total of twelve current priority-setting frameworks from eleven agencies were identified. Ten countries were represented: Canada, Denmark, England, Hungary, Israel, Scotland, Spain, Sweden, The Netherlands, and United States. Fifty-nine unique HTA priority-setting criteria were divided into eleven categories (alternatives; budget impact; clinical impact; controversial nature of proposed technology; disease burden; economic impact; ethical, legal, or psychosocial implications; evidence; interest; timeliness of review; variation in rates of use). Differences across HTA agencies were found regarding procedures for categorizing, scoring, and weighing of policy criteria. Variability exists in the methods for priority setting of health technology assessment across HTA agencies. Quantitative rating methods and consideration of cost benefit for priority setting were seldom used. These study results will assist HTA agencies that are re-visiting or developing their prioritization methods.

What should we teach the teachers? Identifying the learning priorities of clinical supervisors.

PubMed

Bearman, Margaret; Tai, Joanna; Kent, Fiona; Edouard, Vicki; Nestel, Debra; Molloy, Elizabeth

2018-03-01

Clinicians who teach are essential for the health workforce but require faculty development to improve their educational skills. Curricula for faculty development programs are often based on expert frameworks without consideration of the learning priorities as defined by clinical supervisors themselves. We sought to inform these curricula by highlighting clinical supervisors own requirements through answering the research question: what do clinical supervisors identify as relative strengths and areas for improvement in their teaching practice? This mixed methods study employed a modified version of the Maastricht Clinical Teaching Questionnaire (mMCTQ) which included free-text reflections. Descriptive statistics were calculated and content analysis was conducted on textual comments. 481 (49%) of 978 clinical supervisors submitted their mMCTQs and associated reflections for the research study. Clinical supervisors self-identified relatively strong capability with interpersonal skills or attributes and indicated least capability with assisting learners to explore strengths, weaknesses and learning goals. The qualitative category 'establishing relationships' was the most reported strength with 224 responses. The qualitative category 'feedback' was the most reported area for improvement, with 151 responses. Key areas for curricular focus include: improving feedback practices; stimulating reflective and agentic learning; and managing the logistics of a clinical education environment. Clinical supervisors' self-identified needs provide a foundation for designing engaging and relevant faculty development programs.

[Computerized monitoring for integrated cervical screening. Rationale, methods and indicators of participation].

PubMed

Bucchi, L; Pierri, C; Caprara, L; Cortecchia, S; De Lillo, M; Bondi, A

2003-02-01

This paper presents a computerised system for the monitoring of integrated cervical screening, i.e. the integration of spontaneous Pap smear practice into organised screening. The general characteristics of the system are described, including background and rationale (integrated cervical screening in European countries, impact of integration on monitoring, decentralised organization of screening and levels of monitoring), general methods (definitions, sections, software description, and setting of application), and indicators of participation (distribution by time interval since previous Pap smear, distribution by screening sector--organised screening centres vs public and private clinical settings--, distribution by time interval between the last two Pap smears, and movement of women between the two screening sectors). Also, the paper reports the results of the application of these indicators in the general database of the Pathology Department of Imola Health District in northern Italy.

Shin splints--a review of terminology.

PubMed

Batt, M E

1995-01-01

This review is intended to improve the understanding of and rationale for the use of the term shin splints. Currently the term is used widely and variably, with little consensus of definition. Broadly, it denotes the occurrence of exertional lower leg pain; more specifically, it refers to an anatomical site of periostitis. The literature reports a multiplicity of descriptions and definitions of shin splints resultant from the complex etiologies and differing perceptions of these conditions. It is proposed that the term shin splint be recognized as generic, rather than diagnostic, and that specific conditions that currently exist under this term be differentiated. The etiology and interaction of these related conditions are considered, and a classification based on the current literature is given of conditions currently termed shin splints, providing a rationale for their clinical presentations, investigative findings, and interactions.

What do young people with rheumatic disease believe to be important to research about their condition? A UK-wide study.

PubMed

Parsons, Suzanne; Thomson, Wendy; Cresswell, Katharine; Starling, Bella; McDonagh, Janet E

2017-07-03

The involvement of people of all ages including young people in research is now widely advocated but prioritisation of research topics is still driven largely by professional agendas. Evidence from adult literature has reported a mismatch between a researcher and patient generated list of research topics. There have been no studies to date exploring the priorities of young people with long term conditions other than in SLE. The study aimed to explore the research priorities of young people across the UK with respect to rheumatic conditions. Focus groups were undertaken with young people aged 11-24 years with rheumatic conditions recruited across the UK via members of the Barbara Ansell National Network for Adolescent Rheumatology BANNAR and relevant national charities. Data was analysed using a Framework approach. Participants discussed their beliefs about what should be researched in: Basic Science; Clinical Medicine; Health Services, Psychosocial, and Public Health. They were then invited to prioritize these areas in terms of how much funding they should receive. Thirteen focus groups were held involving 63 participants (18 males: 45 females, mean age 16 years, range 10 to 24) in all four nations of the UK. Young people's research priorities were influenced by whether they felt research would achieve benefits for all or just some patients and long or short term goals. Another influence was whether participants felt that research areas were already well funded. Across all groups, Basic Science was a key priority and participants felt that psychosocial research should be prioritized more. Health Services Research was a lower priority, as the majority of participants were happy with their care. Clinical medicine was not a high priority as young people were happy with their medication or uncomfortable with trying new ones. Finally, for nearly all groups, Public Health was a low priority. Differences were also observed between the two age groups and across the geographically diverse focus groups. Understanding young people's research priorities is important to develop research that is in tune with their needs. The results highlight the importance of considering the whole age range of adolescence and young adulthood as well as geographical diversity. The findings from this work will inform the future research of the Barbara Ansell National Network for Adolescent Rheumatology BANNAR in the UK.

Rationales and treatment approaches underpinning the use of acupuncture and related techniques for plantar heel pain: a critical interpretive synthesis.

PubMed

Clark, Maria T; Clark, Richard J; Toohey, Shane; Bradbury-Jones, Caroline

2017-03-01

Acupuncture shows promise as a treatment for plantar heel pain (PHP) or plantar fasciitis (PF), but data heterogeneity has undermined demonstration of efficacy. Recognising that acupuncture is a diverse field of practice, the aim of this study was to gain a broader, global perspective on the different approaches and rationales used in the application of acupuncture in PHP. We built upon an earlier systematic review (which was limited by the necessity of a methodological focus on efficacy) using the critical interpretive synthesis (CIS) method to draw upon a wider international sample of 25 clinical sources, including case reports and case series. Multiple tracks of analysis led to an emergent synthesis. Findings are presented at three levels: primary (summarised data); secondary (patterns observed); and tertiary (emergent synthesis). Multiple treatments and rationales were documented but no single approach dominated. Notable contradictions emerged such as the application of moxibustion by some authors and ice by others. Synthesis of findings revealed a 'patchwork' of factors influencing the approaches taken. The complexity of the field of acupuncture was illustrated through the 'lens' of PHP. The 'patchwork' metaphor provides a unifying framework for a previously divergent community of practice and research. Several directions for future research were identified, such as: importance of prior duration; existence of diagnostic subgroups; and how practitioners make clinical decisions and report their findings. CIS was found to provide visibility for multiple viewpoints in developing theory and modelling the processes of 'real world' practice by acupuncturists addressing the problem of PHP. 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/.

Rationale and design of a study using a standardized locally procured macronutrient supplement as adjunctive therapy to HIV treatment in Kenya.

PubMed

Sztam, Kevin A; Ndirangu, Murugi; Sheriff, Muhsin; Arpadi, Stephen M; Hawken, Mark; Rashid, Juma; Deckelbaum, Richard J; El Sadr, Wafaa M

2013-01-01

Poor nutritional status at initiation of antiretroviral therapy (ART) is predictive of mortality. Decreased dietary intake is a major determinant of weight loss in HIV. Despite a biological rationale to treat undernutrition in adults receiving ART, few studies have provided data on feasibility, safety, effectiveness, and sustainability of specific macronutrient supplements with HIV treatment in adults, especially supplements such as a food basket, a supplement approach seldom evaluated in spite of its wide use. We present the rationale and design for a study of a locally procured macronutrient supplement given to HIV-infected patients initiating ART with a body mass index (BMI) ≤20.0 kg/m(2). The objective was to determine feasibility of procurement, distribution, safety and to obtain preliminary effectiveness data for a locally procured supplement. The design was a comparative study for 200 adult participants at two Kenya government-supported clinics. The primary outcome was BMI at 24 weeks. Supplement duration was 24 weeks, total follow-up was 48 weeks, and the study included a comparison site. Novel aspects of this study include use of a standardized macronutrient supplement to protect the participant against household food sharing, and a complementary micronutrient supplement. Comprehensive data collected included dietary intake, HIV-related quality-of-life, food security, neuropsychiatric assessments, laboratory studies, and household geomapping. Assessments were made at baseline, at 24 weeks, and at 48 weeks post-ART initiation. Challenges included establishing a partnership with local millers, distribution from the HIV clinic, food safety, and tracking of participants. These findings will help inform nutrition support programming in Kenya and similar settings, and provide needed data regarding use of macronutrient supplements as an adjunctive intervention with ART.

Setting high-impact clinical research priorities for the Society for Vascular Surgery.

PubMed

Kraiss, Larry W; Conte, Michael S; Geary, Randolph L; Kibbe, Melina; Ozaki, C Keith

2013-02-01

With the overall goal of enhancing the effectiveness and efficiency of vascular care, the Society for Vascular Surgery (SVS) recently completed a process by which it identified its top clinical research priorities to address critical gaps in knowledge guiding practitioners in prevention and treatment of vascular disease. After a survey of the SVS membership, a panel of SVS committee members and opinion leaders considered 53 distinct research questions through a structured process that resulted in identification of nine clinical issues that were felt to merit immediate attention by vascular investigators and external funding agencies. These are, in order of priority: (1) define optimal management of asymptomatic carotid stenosis, (2) compare the effectiveness of medical vs invasive treatment (open or endovascular) of vasculogenic claudication, (3) compare effectiveness of open vs endovascular infrainguinal revascularization as initial treatment of critical limb ischemia, (4) develop and compare the effectiveness of clinical strategies to reduce cardiovascular and other perioperative complications (eg, wound) after vascular intervention, (5) compare the effectiveness of strategies to enhance arteriovenous fistula maturation and durability, (6) develop best practices for management of chronic venous ulcer, (7) define optimal adjunctive medical therapy to enhance the success of lower extremity revascularization, (8) identify and evaluate medical therapy to prevent abdominal aortic aneurysm growth, and (9) evaluate ultrasound vs computed tomographic angiography surveillance after endovascular aneurysm repair. Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Identification of Translational Dermatology Research Priorities in the UK; Results of an e-Delphi Exercise

PubMed Central

Healy, E.; Reynolds, N.J.

2016-01-01

Summary Background Translational research is the direct application of basic and applied research to patient care. It is estimated that there are at least 2,000 different skin diseases, thus there are considerable challenges in seeking to undertake research on each of these disorders. Objective This eDelphi exercise was conducted in order to generate a list of translational dermatology research questions which are regarded as a priority for further investigations. Results During the first phase of the eDelphi, 228 research questions were generated by an expert panel which included clinical academic dermatologists, clinical dermatologists, non-clinical scientists, dermatology trainees and representatives from patient support groups. Following completion of the second and third phases, 40 questions on inflammatory skin disease, 20 questions on structural skin disorders / genodermatoses, 37 questions on skin cancer and 8 miscellaneous questions were designated as priority translational dermatology research questions (PRQs). In addition to PRQs on a variety of disease areas (including multiple PRQs on psoriasis, eczema, squamous cell carcinoma (SCC) and melanoma), there were a number of cross-cutting themes which identified a need to investigate mechanisms / pathogenesis of disease and the necessity to improve treatments for patients with skin disease. Conclusion It is predicted that this list of PRQs will help to provide a strategic direction for translational dermatology research in the UK and that addressing this list of questions will ultimately provide clinical benefit for substantial numbers of subjects with skin disorders. PMID:26149834

Prioritization and willingness to pay for bariatric surgery: the patient perspective

PubMed Central

Gill, Richdeep S.; Majumdar, Sumit R.; Wang, Xiaoming; Tuepah, Rebecca; Klarenbach, Scott W.; Birch, Daniel W.; Karmali, Shahzeer; Sharma, Arya M.; Padwal, Raj S.

2014-01-01

Background Access to publicly funded bariatric surgery is limited, potential candidates face lengthy waits, and no universally accepted prioritization criteria exist. We examined patients’ perspectives regarding prioritization for surgery. Methods We surveyed consecutively recruited patients awaiting bariatric surgery about 9 hypothetical scenarios describing patients waiting for surgery. Respondents were asked to rank the priority of these hypothetical patients on the wait list relative to their own. Scenarios examined variations in age, clinical severity, functional impairment, social dependence and socioeconomic status. Willingness to pay for faster access was assessed using a 5-point ordinal scale and analyzed using multivariable logistic regression. Results The 99 respondents had mean age of 44.7 ± 9.9 years, 76% were women, and the mean body mass index was 47.3 ± SD 7.6. The mean wait for surgery was 34.4 ± 9.4 months. Respondents assigned similar priority to hypothetical patients with characteristics identical to theirs (p = 0.22) and higher priority (greater urgency) to those exhibiting greater clinical severity (p < 0.001) and functional impairment (p = 0.003). Lower priority was assigned to patients at the extremes of age (p = 0.006), on social assistance (p < 0.001) and of high socioeconomic status (p < 0.001). Most (85%) respondents disagreed with payment to expedite access, although participants earning more than $80 000/year were less likely to disagree. Conclusion Most patients waiting for bariatric surgery consider greater clinical severity and functional impairments related to obesity to be important prioritization indicators and disagreed with paying for faster access. These findings may help inform future efforts to develop acceptable prioritization strategies for publicly funded bariatric surgery. PMID:24461224

Patients' views on priority setting in neurosurgery: A qualitative study.

PubMed

Gunaratnam, Caroline; Bernstein, Mark

2016-01-01

Accountability for Reasonableness is an ethical framework which has been implemented in various health care systems to improve and evaluate the fairness of priority setting. This framework is grounded on four mandatory conditions: relevance, publicity, appeals, and enforcement. There have been few studies which have evaluated the patient stakeholders' acceptance of this framework; certainly no studies have been done on patients' views on the prioritization system for allocating patients for operating time in a system with pressure on the resource of inpatient beds. The aim of this study is to examine neurosurgical patients' views on the prioritization of patients for operating theater (OT) time on a daily basis at a tertiary and quaternary referral neurosurgery center. Semi-structured face-to-face interviews were conducted with thirty-seven patients, recruited from the neurosurgery clinic at Toronto Western Hospital. Family members and friends who accompanied the patient to their clinic visit were encouraged to contribute to the discussion. Interviews were audio recorded, transcribed verbatim, and subjected to thematic analysis using open and axial coding. Overall, patients are supportive of the concept of a priority-setting system based on fairness, but felt that a few changes would help to improve the fairness of the current system. These changes include lowering the level of priority given to volume-funded cases and providing scheduled surgeries that were previously canceled a higher level of prioritization. Good communication, early notification, and rescheduling canceled surgeries as soon as possible were important factors that directly reflected the patients' confidence level in their doctor, the hospital, and the health care system. This study is the first clinical qualitative study of patients' perspective on a prioritization system used for allocating neurosurgical patients for OT time on a daily basis in a socialized not-for-profit health care system with fixed resources.

Prioritization and willingness to pay for bariatric surgery: the patient perspective.

PubMed

Gill, Richdeep S; Majumdar, Sumit R; Wang, Xiaoming; Tuepah, Rebecca; Klarenbach, Scott W; Birch, Daniel W; Karmali, Shahzeer; Sharma, Arya M; Padwal, Raj S

2014-02-01

Access to publicly funded bariatric surgery is limited, potential candidates face lengthy waits, and no universally accepted prioritization criteria exist. We examined patients' perspectives regarding prioritization for surgery. We surveyed consecutively recruited patients awaiting bariatric surgery about 9 hypothetical scenarios describing patients waiting for surgery. Respondents were asked to rank the priority of these hypothetical patients on the wait list relative to their own. Scenarios examined variations in age, clinical severity, functional impairment, social dependence and socioeconomic status. Willingness to pay for faster access was assessed using a 5-point ordinal scale and analyzed using multivariable logistic regression. The 99 respondents had mean age of 44.7 ± 9.9 years, 76% were women, and the mean body mass index was 47.3 ± SD 7.6. The mean wait for surgery was 34.4 ± 9.4 months. Respondents assigned similar priority to hypothetical patients with characteristics identical to theirs (p = 0.22) and higher priority (greater urgency) to those exhibiting greater clinical severity (p < 0.001) and functional impairment (p = 0.003). Lower priority was assigned to patients at the extremes of age (p = 0.006), on social assistance (p < 0.001) and of high socioeconomic status (p < 0.001). Most (85%) respondents disagreed with payment to expedite access, although participants earning more than $80 000/year were less likely to disagree. Most patients waiting for bariatric surgery consider greater clinical severity and functional impairments related to obesity to be important prioritization indicators and disagreed with paying for faster access. These findings may help inform future efforts to develop acceptable prioritization strategies for publicly funded bariatric surgery.

Reinterpreting Responsiveness for Health Systems Research in Low and Middle-Income Countries.

PubMed

Pratt, Bridget; Hyder, Adnan A

2015-07-01

The ethical concept of responsiveness has largely been interpreted in the context of international clinical research. In light of the increasing conduct of externally funded health systems research (HSR) in low- and middle-income countries (LMICs), this article examines how responsiveness might be understood for such research and how it can be applied. It contends that four features (amongst others) set HSR in LMICs apart from international clinical research: a focus on systems; being context-driven; being policy-driven; and being closely linked to development objectives. These features support reinterpreting responsiveness for HSR in LMICs as responsiveness to systems needs, where health system performance assessments can be relied upon to identify systems needs, and/or responsiveness to systems priorities, which entails aligning research with HSR priorities set through country-owned processes involving national and sub-national policymakers from host countries. Both concepts may be difficult to achieve in practice. Country ownership is not an established fact for many countries and alignment to their priorities may be meaningless without it. It is argued that more work is, therefore, needed to identify strategies for how the responsiveness requirement can be ethically fulfilled for HSR in LMICs under non-ideal conditions such as where host countries have not set HSR priorities via country-owned processes. Embeddedness is proposed as one approach that could be the focus of further development. © 2014 John Wiley & Sons Ltd.

Amniotic therapeutic biomaterials in urology: current and future applications.

PubMed

Oottamasathien, Siam; Hotaling, James M; Craig, James R; Myers, Jeremy B; Brant, William O

2017-10-01

To examine the rationale and applications of amniotic tissue augmentation in urological surgery. Published literature in English-language was reviewed for basic science and clinical use of amniotic or amnion-chorionic tissue in genitourinary tissues. Basic science and animal studies support the likely benefit of clinical applications of amnion-derived tissues in a variety of urologic interventions. The broad number of properties found in amniotic membrane, coupled with its immunologically privileged status presents a number of future applications in the urological surgical realm. These applications are in their clinical infancy and suggest that further studies are warranted to investigate the use of these products in a systematic fashion.

Research priorities in cancer cachexia: The University of Rochester Cancer Center NCI Community Oncology Research Program Research Base Symposium on Cancer Cachexia and Sarcopenia.

PubMed

Dunne, Richard F; Mustian, Karen M; Garcia, Jose M; Dale, William; Hayward, Reid; Roussel, Breton; Buschmann, Mary M; Caan, Bette J; Cole, Calvin L; Fleming, Fergal J; Chakkalakal, Joe V; Linehan, David C; Hezel, Aram F; Mohile, Supriya G

2017-12-01

Cancer cachexia remains understudied and there are no standard treatments available despite the publication of an international consensus definition and the completion of several large phase III intervention trials in the past 6 years. In September 2015, The University of Rochester Cancer Center NCORP Research Base led a Symposium on Cancer Cachexia and Sarcopenia with goals of reviewing the state of the science, identifying knowledge gaps, and formulating research priorities in cancer cachexia through active discussion and consensus. Research priorities that emerged from the discussion included the implementation of morphometrics into clinical decision making, establishing specific diagnostic criteria for the stages of cachexia, expanding patient selection in intervention trials, identifying clinically meaningful trial endpoints, and the investigation of exercise as an intervention for cancer cachexia. Standardizing how we define and measure cancer cachexia, targeting its complex biologic mechanisms, enrolling patients early in their disease course, and evaluating exercise, either alone or in combination, were proposed as initiatives that may ultimately result in the improved design of cancer cachexia therapeutic trials.

[Psychiatry with open doors. Part 1: Rational for an open door for acute psychiatry].

PubMed

Sollberger, D; Lang, U E

2014-03-01

Despite the reform efforts of the last decades modern acute psychiatry still stands between conflicting priorities in everyday practice. The protection of patient autonomy might conflict with a regulatory mandate of psychiatry in societal contexts and the necessity of coercive measures and involuntary treatment might become problematic with respect to presumed but contentious interests of the patient. The conflicts particularly concern questions of involuntary commitment, door closing, coercive and isolation measures. Research on the topic of therapeutic effectiveness of these practices is rare. Accordingly, the practice depends on the federal state, hospital and ward and is very heterogeneous. Epidemiological prognosis predicts an increase of psychiatric disorders; however, simultaneously in terms of medical ethics the warranty of patient autonomy, shared decision-making and informed consent in psychiatry become increasingly more important. This challenges structural and practical changes in psychiatry, particularly in situations of self and third party endangerment which are outlined and a rationale for an opening of the doors in acute psychiatric wards is provided.

Ergodic theorem, ergodic theory, and statistical mechanics

PubMed Central

Moore, Calvin C.

2015-01-01

This perspective highlights the mean ergodic theorem established by John von Neumann and the pointwise ergodic theorem established by George Birkhoff, proofs of which were published nearly simultaneously in PNAS in 1931 and 1932. These theorems were of great significance both in mathematics and in statistical mechanics. In statistical mechanics they provided a key insight into a 60-y-old fundamental problem of the subject—namely, the rationale for the hypothesis that time averages can be set equal to phase averages. The evolution of this problem is traced from the origins of statistical mechanics and Boltzman's ergodic hypothesis to the Ehrenfests' quasi-ergodic hypothesis, and then to the ergodic theorems. We discuss communications between von Neumann and Birkhoff in the Fall of 1931 leading up to the publication of these papers and related issues of priority. These ergodic theorems initiated a new field of mathematical-research called ergodic theory that has thrived ever since, and we discuss some of recent developments in ergodic theory that are relevant for statistical mechanics. PMID:25691697

LAWS (Laser Atmospheric Wind Sounder) earth observing system

NASA Technical Reports Server (NTRS)

1988-01-01

Wind profiles can be measured from space using current technology. These wind profiles are essential for answering many of the interdisciplinary scientific questions to be addressed by EOS, the Earth Observing System. This report provides guidance for the development of a spaceborne wind sounder, the Laser Atmospheric Wind Sounder (LAWS), discussing the current state of the technology and reviewing the scientific rationale for the instrument. Whether obtained globally from the EOS polar platform or in the tropics and subtropics from the Space Station, wind profiles from space will provide essential information for advancing the skill of numerical weather prediction, furthering knowledge of large-scale atmospheric circulation and climate dynamics, and improving understanding of the global biogeochemical and hydrologic cycles. The LAWS Instrument Panel recommends that it be given high priority for new instrument development because of the pressing scientific need and the availability of the necessary technology. LAWS is to measure wind profiles with an accuracy of a few meters per second and to sample at intervals of 100 km horizontally for layers km thick.

Economics of Lunar Mineral Exploration

NASA Astrophysics Data System (ADS)

Blair, Brad R.

1999-01-01

Exploration of space is increasingly being rationalized by the potential for long-term commercial payoffs. The commercial use of lunar resources is gaining relevance as technology and infrastructure increase, and will depend on an adequate foundation of geological information. While past lunar exploration has provided detailed knowledge about the composition, geologic history and structural characteristics of the lunar surface at six locations, the rest of the Moon remains largely unexplored. The purpose of this paper is to describe traditional methods and decision criteria used in the mineral exploration business. Rationale for terrestrial mineral exploration is firmly entrenched within the context of economic gain, with asset valuation forming the primary feedback to decision making. The paper presents a summary of relevant knowledge from the field of exploration economics, applying it to the case of space mineral development. It includes a description of the current paradigm of both space exploration and terrestrial mineral exploration, as each pertains to setting priorities and decision making. It briefly examines issues related to space resource demand, extraction and transportation to establish its relevance.

Investment Appeal of the Recreational Potential of the Region

NASA Astrophysics Data System (ADS)

Galanina, T. V.; Mikhailov, V. G.; Golofastova, N. N.; Koroleva, T. G.

2017-01-01

The article deals with the issue of environmental and economic assessment of natural and recreational potential of Kuzbass. The purpose of the research is to study the trends in the development of the regional recreational potential, as well as to develop the methodological bases for creation of resort and recreational areas to improve the health of the population and increase the investment appeal of Kemerovo region. The constraints to improve the investment, environmental and economic performance of regional resorts are identified. The main result of the research is the development of the project to improve the stability of the socio-economic system of the region, on the basis of the mitigation of environmental and economic risks and the systematic development of recreational infrastructure. The practical significance of the study consists of the recommendations for regional and federal authorities concerning the development of socio-economic plans and forecasts, including the provision of a rationale for the status of priority development territories.

Scientific rationale and concepts for in situ probe exploration of Uranus and Neptune

NASA Astrophysics Data System (ADS)

Mousis, O.; Atkinson, D.; Amato, M.; Aslam, S.; Atreya, S.; Blanc, M.; Brugger, B.; Calcutt, S.; Cavalié, T.; Charnoz, S.; Coustenis, A.; Deleuil, M.; Dobrijevic, M.; Encrenaz, T.; Ferri, F.; Fletcher, L.; Guillot, T.; Hartogh, P.; Hofstadter, M.; Hueso, R.

2017-09-01

Uranus and Neptune, referred to as ice giants, are fundamentally different from the better-known gas giants (Jupiter and Saturn). Exploration of an ice giant system is a high-priority science objective, as these systems (including the magnetosphere, satellites, rings, atmosphere, and interior) challenge our understanding of planetary formation and evolution. The importance of the ice giants is reflected in NASA's 2011 Decadal Survey, comments from ESA's SSC in response to L2/L3 mission proposals and results of the 2017 NASA/ESA Ice Giants study. A crucial part of exploration of the ice giants is in situ sampling of the atmosphere via an atmospheric probe. A probe would bring insights in two broad themes: the formation history of our Solar System and the processes at play in planetary atmospheres. Here we summarize the science driver for in situ measurements at these two planets and discuss possible mission concepts that would be consistent with the constraints of ESA M-class missions.

Interim Methadone and Patient Navigation in Jail: Rationale and Design of a Randomized Clinical Trial

PubMed Central

Schwartz, Robert P.; Kelly, Sharon M.; Mitchell, Shannon G.; Dunlap, Laura; Zarkin, Gary A.; Sharma, Anjalee; O’Grady, Kevin E.; Jaffe, Jerome H.

2016-01-01

Background Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. Methods This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30 days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. Results We describe the background and rationale for the study, its aims, hypotheses, and study design. Conclusions Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. PMID:27282117

An assessment of filamentous carbon fibre for the treatment of tendon injury in the horse.

PubMed

Goodship, A E; Brown, P N; Yeats, J J; Jenkins, D H; Silver, I A

1980-03-08

The results of an assessment of carbon fibre for biological use are given, with particular reference to the clinical use of the material in the treatment of equine tendon injury. Biocompatability of the fibres is assessed using fibroblast cell cultures and replacement of normal tendon with carbon fibre prostheses in experimental animals. The rationale and technique for using this material in clinical cases of tendon injury in the racehorse are described. Results are given from 62 implant operations in a limited series of 40 horses.

Omarigliptin (MK-3102): A Novel Long-Acting DPP-4 Inhibitor for Once-Weekly Treatment of Type 2 Diabetes

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

Biftu, Tesfaye; Sinha-Roy, Ranabir; Chen, Ping

In our effort to discover DPP-4 inhibitors with added benefits over currently commercially available DPP-4 inhibitors, MK-3102 (omarigliptin), was identified as a potent and selective dipeptidyl peptidase 4 (DPP-4) inhibitor with an excellent pharmacokinetic profile amenable for once-weekly human dosing and selected as a clinical development candidate. This manuscript summarizes the mechanism of action, scientific rationale, medicinal chemistry, pharmacokinetic properties, and human efficacy data for omarigliptin, which is currently in phase 3 clinical development.

Seizures and Epilepsy: An Overview for Neuroscientists

PubMed Central

Stafstrom, Carl E.; Carmant, Lionel

2015-01-01

Epilepsy is one of the most common and disabling neurologic conditions, yet we have an incomplete understanding of the detailed pathophysiology and, thus, treatment rationale for much of epilepsy. This article reviews the clinical aspects of seizures and epilepsy with the goal of providing neuroscientists an introduction to aspects that might be amenable to scientific investigation. Seizures and epilepsy are defined, diagnostic methods are reviewed, various clinical syndromes are discussed, and aspects of differential diagnosis, treatment, and prognosis are considered to enable neuroscientists to formulate basic and translational research questions. PMID:26033084

Learning to Change: The Rationale for The Use of Motivational Interviewing in Higher Education

ERIC Educational Resources Information Center

Wells, Harvey; Jones, Anna

2018-01-01

Motivational interviewing is a technique developed for use in clinical contexts in order to help people change unhealthy behaviours. However, because it is centred on change, is non-judgemental and collaborative, it is ideal to be adapted for use in teaching. This paper considers the theoretical basis for its use in higher education settings by…

Rationale and design of the vitamin D and type 2 diabetes (D2d) study: a diabetes prevention trial

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supp...

Seven durable ideas.

PubMed

Glaser, John P

2008-01-01

Partners Healthcare, and its affiliated hospitals, have a long track record of accomplishments in clinical information systems implementations and research. Seven ideas have shaped the information systems strategies and tactics at Partners; centrality of processes, organizational partnerships, progressive incrementalism, agility, architecture, embedded research, and engage the field. This article reviews the ideas and discusses the rationale and steps taken to put the ideas into practice.

Seven Durable Ideas

PubMed Central

Glaser, John P.

2008-01-01

Partners Healthcare, and its affiliated hospitals, have a long track record of accomplishments in clinical information systems implementations and research. Seven ideas have shaped the information systems strategies and tactics at Partners; centrality of processes, organizational partnerships, progressive incrementalism, agility, architecture, embedded research, and engage the field. This article reviews the ideas and discusses the rationale and steps taken to put the ideas into practice. PMID:18308978

Investigating methotrexate toxicity within a randomized double-blinded, placebo-controlled trial: rationale and design of the Cardiovascular Inflammation Reduction Trial-Adverse Events (CIRT-AE) Study

USDA-ARS?s Scientific Manuscript database

Background: The role of low dose methotrexate (LDM) in potential serious toxicities remains unclear despite its common use. Prior observational studies investigating LDM toxicity compared LDM to other active drugs. Prior placebo-controlled clinical trials of LDM in inflammatory conditions were not l...

Health care engineering management.

PubMed

Jarzembski, W B

1980-01-01

Today, health care engineering management is merely a concept of dreamers, with most engineering decisions in health care being made by nonengineers. It is the purpose of this paper to present a rationale for an integrated hospital engineering group, and to acquaint the clinical engineer with some of the salient features of management concepts. Included are general management concepts, organization, personnel management, and hospital engineering systems.

Signs of Suicide: Using Road Drawings with Inmates on Suicide Observation at a County Jail

ERIC Educational Resources Information Center

Hanes, Michael J.

2008-01-01

Suicide is a leading cause of death in jails. This article discusses the use of road drawings as part of a clinical interview by an art therapist to evaluate an inmate's risk for self-harm. Following an overview of suicide in correctional settings, the rationale and procedure for administering road drawings are explained. Examples produced by…

Meditation: Rationales, Experimental Effects, and Methodological Issues

DTIC Science & Technology

1986-04-01

psychotherapeutic communities . Such an expansion of the term highlights the growing Western view of meditation as a physiological, as well a a psychological...and other meditations are currently holding the attention of the Western psychiatric community . Together with Yogic techniques. Buddhist meditations...are increasingly contributing to Western psychological doctrine and therapeutic practice. This reception by the clinical community in particular is

A review and rationale for studying the cardiovascular effects of drinking water arsenic in women of reproductive age

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

Kwok, Richard K., E-mail: rkwok@rti.org

2007-08-01

Drinking water arsenic has been shown to be associated with a host of adverse health outcomes at exposure levels > 300 {mu}g of As/L. However, the results are not consistent at exposures below this level. We have reviewed selected articles that examine the effects of drinking water arsenic on cardiovascular outcomes and present a rationale for studying these effects on women of reproductive age, and also over the course of pregnancy when they would potentially be more susceptible to adverse cardiovascular and reproductive outcomes. It is only recently that reproductive effects have been linked to drinking water arsenic. However, theremore » is a paucity of information about the cardiovascular effects of drinking water arsenic on women of reproductive age. Under the cardiovascular challenge of pregnancy, we hypothesize that women with a slightly elevated exposure to drinking water arsenic may exhibit adverse cardiovascular outcomes at higher rates than in the general population. Studying sensitive clinical and sub-clinical indicators of disease in susceptible sub-populations may yield important information about the potentially enormous burden of disease related to low-level drinking water arsenic exposure.« less

A doctor in the house: rationale for providing on-site urological consultation to geriatric patients in nursing health care facilities.

PubMed

Watson, Richard A; Suchak, Nihirika; Steel, Knight

2010-08-01

To establish a rationale for providing on-site urological care on a regular basis in the nursing health care center setting and to share "lessons learned," which we have garnered in providing that care over a 5-year experience. We have reviewed and assessed our experiences in providing urological outreach to nursing health care center patients. Our outreach program has been well received both by patients and by health care center personnel. Over this time, we have capitalized on many advantages that this initiative offers, and we have gained, through this experience, several "lessons learned," not only regarding what to do, but also what to avoid. Advantages to on-site urological care include: (1) timely, targeted clinical intervention; (2) significant disease prevention; (3) expedition of treatment; (4) health care provider education; and (5) rich opportunities for clinical investigation. In addition, the on-site urologist can provide the health care center with helpful advice and validation in meeting federal and state health care requirements. Unfortunately, to date, remuneration for such programs has been discouraging. Federal and state regulations continue to impede innovative change. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Rationale and design of a large registry on renal denervation: the Global SYMPLICITY registry.

PubMed

Böhm, Michael; Mahfoud, Felix; Ukena, Christian; Bauer, Axel; Fleck, Eckart; Hoppe, Uta C; Kintscher, Ulrich; Narkiewicz, Krzysztof; Negoita, Manuela; Ruilope, Luis; Rump, L Christian; Schlaich, Markus; Schmieder, Roland; Sievert, Horst; Weil, Joachim; Williams, Bryan; Zeymer, Uwe; Mancia, Giuseppe

2013-08-22

Hypertension is a global healthcare concern associated with a wide range of comorbidities. The recognition that elevated sympathetic drive plays an important role in the pathogenesis of hypertension led to the use of renal artery denervation to interrupt the efferent and afferent sympathetic nerves between the brain and kidneys to lower blood pressure. Clinical trials of the Symplicity™ renal denervation system have demonstrated that radiofrequency ablation of renal artery nerves is safe and significantly lowers blood pressure in patients with severe resistant (systolic BP >160 mmHg) hypertension. Smaller ancillary studies in hypertensive patients suggest a benefit from renal denervation in a variety of conditions such as chronic kidney disease, glucose intolerance, sleep apnoea and heart failure. The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real-world uncontrolled hypertensive patients, looking first at subjects with severe resistant hypertension to confirm the results of prior clinical trials, but then also subjects with a wider range of baseline blood pressure and coexisting comorbidities. The rationale, design and first baseline data from the Global SYMPLICITY registry are presented.

Recent advances in botulinum neurotoxin inhibitor development.

PubMed

Kiris, Erkan; Burnett, James C; Kane, Christopher D; Bavari, Sina

2014-01-01

Botulinum neurotoxins (BoNTs) are endopeptidases that target motor neurons and block acetylcholine neurotransmitter release. This action results in the muscle paralysis that defines the disease botulism. To date, there are no FDA-approved therapeutics to treat BoNT-mediated paralysis after intoxication of the motor neuron. Importantly, the rationale for pursuing treatments to counter these toxins is driven by their potential misuse. Current drug discovery efforts have mainly focused on small molecules, peptides, and peptidomimetics that can directly and competitively inhibit BoNT light chain proteolytic activity. Although this is a rational approach, direct inhibition of the Zn(2+) metalloprotease activity has been elusive as demonstrated by the dearth of candidates undergoing clinical evaluation. Therefore, broadening the scope of viable targets beyond that of active site protease inhibitors represents an additional strategy that could move the field closer to the clinic. Here we review the rationale, and discuss the outcomes of earlier approaches and highlight potential new targets for BoNT inhibition. These include BoNT uptake and processing inhibitors, enzymatic inhibitors, and modulators of neuronal processes associated with toxin clearance, neurotransmitter potentiation, and other pathways geared towards neuronal recovery and repair.

Clinical pharmacology and therapeutics in undergraduate medical education in the UK: current status.

PubMed Central

Walley, T; Bligh, J; Orme, M; Breckenridge, A

1994-01-01

1. Medical undergraduate education is currently undergoing major changes in the UK in response to calls for the development of a core curriculum. Teaching in clinical pharmacology and therapeutics will also change to meet these demands. A postal survey was conducted to assess the current status of teaching in these subjects. 2. A questionnaire based on previous similar surveys conducted elsewhere was sent to departments or individuals in 27 medical schools in the UK; 22 (81%) replied. 3. Departmental priorities were defined as (in order): clinical research, undergraduate teaching, basic scientific research and clinical service provision. No change in these priorities in the future was foreseen by respondents. 4. Teaching methods were for the most part traditional, with the lecture as the most widely used and important technique. Specific clinical teaching was conducted by some and was considered very important by them. Teaching by problem solving was much less common. 5. Respondents were asked for free text comments; many of the remarks suggested dissatisfaction with the resources and time currently available for teaching in clinical pharmacology and therapeutics. Some expressed significant concerns that their teaching commitment would be reduced further by the development of the core curriculum. PMID:8186059

Identifying educational priorities for occupational therapy students to prepare for mental health practice in Australia and New Zealand: Opinions of practising occupational therapists.

PubMed

Scanlan, Justin Newton; Pépin, Geneviève; Haracz, Kirsti; Ennals, Priscilla; Webster, Jayne S; Meredith, Pamela J; Batten, Rachel; Bowman, Siann; Bonassi, Marianne; Bruce, Rosie

2015-10-01

The effective preparation of occupational therapy students for mental health practice is critical to facilitate positive consumer outcomes, underpin optimal practice and support new graduates' professional identity. This project was established to determine a set of 'educational priorities' for occupational therapy students to prepare them for current (and future) entry-level practice in mental health, from the perspective of mental health occupational therapists in Australia and New Zealand. The study included two phases. In Phase One, participants identified what they considered to be important educational priorities for occupational therapy students to prepare them for practice in mental health. For Phase Two, an 'expert panel' was assembled to review and rank these using a Policy Delphi approach. Eighty-five participants provided educational priorities in Phase One. These were grouped into a total of 149 educational themes. In Phase Two, the expert panel (consisting of 37 occupational therapists from diverse locations and practice settings) prioritised these themes across three Delphi rounds. A final priority list was generated dividing educational themes into three prioritised categories: 29 'Essential', 25 'Important' and 44 'Optional' priorities. Highest-ranked priorities were: clinical reasoning, client-centred practice, therapeutic use of self, functional implications of mental illness, therapeutic use of occupation and mental health fieldwork experience. The priority list developed as part of this project provides additional information to support the review of occupational therapy curricula across Australia and New Zealand to ensure that new graduates are optimally prepared for mental health practice. © 2015 Occupational Therapy Australia.

A Business Case Framework for Planning Clinical Nurse Specialist-Led Interventions.

PubMed

Bartlett Ellis, Rebecca J; Embree, Jennifer L; Ellis, Kurt G

2015-01-01

The purpose of this article is to describe a business case framework that can guide clinical nurse specialists (CNS) in clinical intervention development. Increased emphasis on cost-effective interventions in healthcare requires skills in analyzing the need to make the business case, especially for resource-intensive interventions. This framework assists the CNS to anticipate resource use and then consider if the intervention makes good business sense. We describe a business case framework that can assist the CNS to fully explore the problem and determine if developing an intervention is a good investment. We describe several analyses that facilitate making the business case to include the following: problem identification and alignment with strategic priorities, needs assessment, stakeholder analysis, market analysis, intervention implementation planning, financial analysis, and outcome evaluation. The findings from these analyses can be used to develop a formal proposal to present to hospital leaders in a position to make decisions. By aligning intervention planning with organizational priorities and engaging patients in the process, interventions will be more likely to be implemented in practice and produce robust outcomes. The business case framework can be used to justify to organization decision makers the need to invest resources in new interventions that will make a difference for quality outcomes as well as the financial bottom line. This framework can be used to plan interventions that align with organizational strategic priorities, plan for associated costs and benefits, and outcome evaluation. Clinical nurse specialists are well positioned to lead clinical intervention projects that will improve the quality of patient care and be cost-effective. To do so requires skill development in making the business case.

Recognition and Management of Sepsis in Children: Practice Patterns in the Emergency Department.

PubMed

Thompson, Graham C; Macias, Charles G

2015-10-01

Pediatric sepsis remains a leading cause of morbidity and mortality. Understanding current practice patterns and challenges is essential to inform future research and education strategies. Our aim was to describe the practice patterns of pediatric emergency physicians (PEPs) in the recognition and management of sepsis in children and to identify perceived priorities for future research and education. We conducted a cross-sectional, internet-based survey of members of the American Academy of Pediatrics, Section on Emergency Medicine and Pediatric Emergency Research Canada. The survey was internally derived, externally validated, and distributed using a modified Dillman methodology. Rank scores (RS) were calculated for responses using Likert-assigned frequency values. Tachycardia, mental-status changes, and abnormal temperature (RS = 83.7, 80.6, and 79.6) were the highest ranked clinical measures for diagnosing sepsis; white blood cell count, lactate, and band count (RS = 73.5, 70.9, and 69.1) were the highest ranked laboratory investigations. The resuscitation fluid of choice (85.5%) was normal saline. Dopamine was the first-line vasoactive medication (VAM) for cold (57.1%) and warm (42.2%) shock with epinephrine (18.5%) and norepinephrine (25.1%) as second-line VAMs (cold and warm, respectively). Steroid administration increased with complexity of presentation (all-comers 3.8%, VAM-resistant shock 54.5%, chronic steroid users 72.0%). Local ED-specific clinical pathways, national emergency department (ED)-specific guidelines, and identification of clinical biomarkers were described as future priorities. While practice variability exists among clinicians, PEPs continue to rely heavily on clinical metrics for recognizing sepsis. Improved recognition through clinical biomarkers and standardization of care were perceived as priorities. Our results provide a strong framework to guide future research and education strategies in pediatric sepsis. Copyright © 2015 Elsevier Inc. All rights reserved.

Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care--systematic decision aid development and study protocol.

PubMed

Yu, Catherine H; Stacey, Dawn; Sale, Joanna; Hall, Susan; Kaplan, David M; Ivers, Noah; Rezmovitz, Jeremy; Leung, Fok-Han; Shah, Baiju R; Straus, Sharon E

2014-01-22

Care of patients with diabetes often occurs in the context of other chronic illness. Competing disease priorities and competing patient-physician priorities present challenges in the provision of care for the complex patient. Guideline implementation interventions to date do not acknowledge these intricacies of clinical practice. As a result, patients and providers are left overwhelmed and paralyzed by the sheer volume of recommendations and tasks. An individualized approach to the patient with diabetes and multiple comorbid conditions using shared decision-making (SDM) and goal setting has been advocated as a patient-centred approach that may facilitate prioritization of treatment options. Furthermore, incorporating interprofessional integration into practice may overcome barriers to implementation. However, these strategies have not been taken up extensively in clinical practice. To systematically develop and test an interprofessional SDM and goal-setting toolkit for patients with diabetes and other chronic diseases, following the Knowledge to Action framework. 1. Feasibility study: Individual interviews with primary care physicians, nurses, dietitians, pharmacists, and patients with diabetes will be conducted, exploring their experiences with shared decision-making and priority-setting, including facilitators and barriers, the relevance of a decision aid and toolkit for priority-setting, and how best to integrate it into practice.2. Toolkit development: Based on this data, an evidence-based multi-component SDM toolkit will be developed. The toolkit will be reviewed by content experts (primary care, endocrinology, geriatricians, nurses, dietitians, pharmacists, patients) for accuracy and comprehensiveness.3. Heuristic evaluation: A human factors engineer will review the toolkit and identify, list and categorize usability issues by severity.4. Usability testing: This will be done using cognitive task analysis.5. Iterative refinement: Throughout the development process, the toolkit will be refined through several iterative cycles of feedback and redesign. Interprofessional shared decision-making regarding priority-setting with the use of a decision aid toolkit may help prioritize care of individuals with multiple comorbid conditions. Adhering to principles of user-centered design, we will develop and refine a toolkit to assess the feasibility of this approach.

Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care - systematic decision aid development and study protocol

PubMed Central

2014-01-01

Background Care of patients with diabetes often occurs in the context of other chronic illness. Competing disease priorities and competing patient-physician priorities present challenges in the provision of care for the complex patient. Guideline implementation interventions to date do not acknowledge these intricacies of clinical practice. As a result, patients and providers are left overwhelmed and paralyzed by the sheer volume of recommendations and tasks. An individualized approach to the patient with diabetes and multiple comorbid conditions using shared decision-making (SDM) and goal setting has been advocated as a patient-centred approach that may facilitate prioritization of treatment options. Furthermore, incorporating interprofessional integration into practice may overcome barriers to implementation. However, these strategies have not been taken up extensively in clinical practice. Objectives To systematically develop and test an interprofessional SDM and goal-setting toolkit for patients with diabetes and other chronic diseases, following the Knowledge to Action framework. Methods 1. Feasibility study: Individual interviews with primary care physicians, nurses, dietitians, pharmacists, and patients with diabetes will be conducted, exploring their experiences with shared decision-making and priority-setting, including facilitators and barriers, the relevance of a decision aid and toolkit for priority-setting, and how best to integrate it into practice. 2. Toolkit development: Based on this data, an evidence-based multi-component SDM toolkit will be developed. The toolkit will be reviewed by content experts (primary care, endocrinology, geriatricians, nurses, dietitians, pharmacists, patients) for accuracy and comprehensiveness. 3. Heuristic evaluation: A human factors engineer will review the toolkit and identify, list and categorize usability issues by severity. 4. Usability testing: This will be done using cognitive task analysis. 5. Iterative refinement: Throughout the development process, the toolkit will be refined through several iterative cycles of feedback and redesign. Discussion Interprofessional shared decision-making regarding priority-setting with the use of a decision aid toolkit may help prioritize care of individuals with multiple comorbid conditions. Adhering to principles of user-centered design, we will develop and refine a toolkit to assess the feasibility of this approach. PMID:24450385

Research priorities in medical education: A national study.

PubMed

Tootoonchi, Mina; Yamani, Nikoo; Changiz, Tahereh; Yousefy, Alireza

2012-01-01

One preliminary step to strengthen medical education research would be determining the research priorities. The aim of this study was to determine the research priorities of medical education in Iran in 2007-2008. This descriptive study was carried out in two phases. Phase one was performed in 3 stages and used Delphi technique among academic staffs of Isfahan University of Medical Sciences. The three stages included a brainstorming workshop for 140 faculty members and educational experts resulting in a list of research priorities, then, in the second and third stages 99 and 76 questionnaires were distributed among faculty members. In the second phase, the final questionnaires were mailed to educational research center managers of universities type I, II and III, and were distributed among 311 academic members and educational experts to rate the items on a numerical scale ranging from 1 to 10. The most important research priorities included faculty members' development methods, faculty members' motives, satisfaction and welfare, criteria and procedures of faculty members' promotion, teaching methods and learning techniques, job descriptions and professional skills of graduates, quality management in education, second language, clinical education, science production in medicine, faculty evaluation and information technology. This study shows the medial education research priorities in national level and in different types of medical universities in Iran. It is recommended that faculty members and research administrators consider the needs and requirements of education and plan the researches in education according to these priorities.

Research priorities in medical education: A national study

PubMed Central

Tootoonchi, Mina; Yamani, Nikoo; Changiz, Tahereh; Yousefy, Alireza

2012-01-01

BACKGROUND: One preliminary step to strengthen medical education research would be determining the research priorities. The aim of this study was to determine the research priorities of medical education in Iran in 2007-2008. METHODS: This descriptive study was carried out in two phases. Phase one was performed in 3 stages and used Delphi technique among academic staffs of Isfahan University of Medical Sciences. The three stages included a brainstorming workshop for 140 faculty members and educational experts resulting in a list of research priorities, then, in the second and third stages 99 and 76 questionnaires were distributed among faculty members. In the second phase, the final questionnaires were mailed to educational research center managers of universities type I, II and III, and were distributed among 311 academic members and educational experts to rate the items on a numerical scale ranging from 1 to 10. RESULTS: The most important research priorities included faculty members’ development methods, faculty members’ motives, satisfaction and welfare, criteria and procedures of faculty members’ promotion, teaching methods and learning techniques, job descriptions and professional skills of graduates, quality management in education, second language, clinical education, science production in medicine, faculty evaluation and information technology. CONCLUSIONS: This study shows the medial education research priorities in national level and in different types of medical universities in Iran. It is recommended that faculty members and research administrators consider the needs and requirements of education and plan the researches in education according to these priorities. PMID:23248661

Kids and Adults Now! Defeat Obesity (KAN-DO): Rationale, Design and Baseline Characteristics

PubMed Central

Østbye, Truls; Zucker, Nancy; Krause, Katrina M.; Lovelady, Cheryl A.; Evenson, Kelly; Peterson, Bercedis L.; Bastian, Lori A.; Swamy, Geeta K.; West, Deborah J; Brouwer, Rebecca JN

2011-01-01

Background Prevention of childhood obesity is a public health priority. Parents influence a child’s weight by modeling healthy behaviors, controlling food availability and activity opportunities, and appropriate feeding practices. Thus interventions should target education and behavioral change in the parent, and positive, mutually reinforcing behaviors within the family. Methods This paper presents the design, rationale and baseline characteristics of Kids and Adults Now! – Defeat Obesity (KAN-DO), a randomized controlled behavioral intervention trial targeting weight maintenance in children of healthy weight, and weight reduction in overweight children. 400 children aged 2–5 and their overweight or obese mothers in the Triangle and Triad regions of North Carolina are randomized equally to control or the KAN-DO intervention, consisting of mailed family kits encouraging healthy lifestyle change. Eight (monthly) kits are supported by motivational counseling calls and a single group session. Mothers are targeted during a hypothesized “teachable moment” for health behavior change (the birth of a new baby), and intervention content addresses: parenting skills (emotional regulation, authoritative parenting), healthy eating, and physical activity. Results The 400 mother-child dyads randomized to trial are 75% white and 22% black; 19% have a household income of $30,000 or below. At baseline, 15% of children are overweight (85th–95th percentile for body mass index) and 9% are obese (≥95th percentile). Conclusion This intervention addresses childhood obesity prevention by using a family-based, synergistic approach, targeting at-risk children and their mothers during key transitional periods, and enhancing maternal self-regulation and responsive parenting as a foundation for health behavior change. PMID:21300177

Kids and adults now! Defeat Obesity (KAN-DO): rationale, design and baseline characteristics.

PubMed

Ostbye, Truls; Zucker, Nancy L; Krause, Katrina M; Lovelady, Cheryl A; Evenson, Kelly R; Peterson, Bercedis L; Bastian, Lori A; Swamy, Geeta K; West, Deborah G; Brouwer, Rebecca J N

2011-05-01

Prevention of childhood obesity is a public health priority. Parents influence a child's weight by modeling healthy behaviors, controlling food availability and activity opportunities, and appropriate feeding practices. Thus interventions should target education and behavioral change in the parent, and positive, mutually reinforcing behaviors within the family. This paper presents the design, rationale and baseline characteristics of Kids and Adults Now! - Defeat Obesity (KAN-DO), a randomized controlled behavioral intervention trial targeting weight maintenance in children of healthy weight, and weight reduction in overweight children. 400 children aged 2-5 and their overweight or obese mothers in the Triangle and Triad regions of North Carolina are randomized equally to control or the KAN-DO intervention, consisting of mailed family kits encouraging healthy lifestyle change. Eight (monthly) kits are supported by motivational counseling calls and a single group session. Mothers are targeted during a hypothesized "teachable moment" for health behavior change (the birth of a new baby), and intervention content addresses: parenting skills ((e.g., emotional regulation, authoritative parenting), healthy eating, and physical activity. The 400 mother-child dyads randomized to trial are 75% white and 22% black; 19% have a household income of $30,000 or below. At baseline, 15% of children are overweight (85th-95th percentile for body mass index) and 9% are obese (≥ 95th percentile). This intervention addresses childhood obesity prevention by using a family-based, synergistic approach, targeting at-risk children and their mothers during key transitional periods, and enhancing maternal self-regulation and responsive parenting as a foundation for health behavior change. Copyright © 2011 Elsevier Inc. All rights reserved.

Proposed changes in personality and personality disorder assessment and diagnosis for DSM-5 Part I: Description and rationale.

PubMed

Skodol, Andrew E; Clark, Lee Anna; Bender, Donna S; Krueger, Robert F; Morey, Leslie C; Verheul, Roel; Alarcon, Renato D; Bell, Carl C; Siever, Larry J; Oldham, John M

2011-01-01

A major reconceptualization of personality psychopathology has been proposed for DSM-5 that identifies core impairments in personality functioning, pathological personality traits, and prominent pathological personality types. A comprehensive personality assessment consists of four components: levels of personality functioning, personality disorder types, pathological personality trait domains and facets, and general criteria for personality disorder. This four-part assessment focuses attention on identifying personality psychopathology with increasing degrees of specificity, based on a clinician's available time, information, and expertise. In Part I of this two-part article, we describe the components of the new model and present brief theoretical and empirical rationales for each. In Part II, we will illustrate the clinical application of the model with vignettes of patients with varying degrees of personality psychopathology, to show how assessments might be conducted and diagnoses reached.

Rationales for Commonly "Challenged" Taught Books.

ERIC Educational Resources Information Center

Shugert, Diane P., Ed.; And Others

1983-01-01

Intended for teachers, this focused journal issue contains separate rationales for teaching books that have been challenged as appropriate instructional materials. Following a discussion of the purpose for rationales and suggestions for using them, the journal presents rationales for teaching the following books: "To Kill a Mockingbird,""The Diary…

Perceived Educational Needs of the Integrated Care Psychiatric Consultant.

PubMed

Ratzliff, Anna; Norfleet, Kathryn; Chan, Ya-Fen; Raney, Lori; Unützer, Jurgen

2015-08-01

With the increased implementation of models that integrate behavioral health with other medical care, there is a need for a workforce of integrated care providers, including psychiatrists, who are trained to deliver mental health care in new ways and meet the needs of a primary care population. However, little is known about the educational needs of psychiatrists in practice delivering integrated care to inform the development of integrated care training experiences. The educational needs of the integrated care team were assessed by surveying psychiatric consultants who work in integrated care. A convenience sample of 52 psychiatrists working in integrated care responded to the survey. The majority of the topics included in the survey were considered educational priorities (>50% of the psychiatrists rated them as essential) for the psychiatric consultant role. Psychiatrists' perspectives on educational priorities for behavioral health providers (BHPs) and primary care providers (PCPs) were also identified. Almost all psychiatrists reported that they provide educational support for PCPs and BHPs (for PCP 92%; for BHP 96%). The information provided in this report suggests likely educational needs of the integrated care psychiatric consultant and provides insight into the learning needs of other integrated care team members. Defining clear priorities related to the three roles of the integrated care psychiatric consultant (clinical consultant, clinical educator, and clinical team leader) will be helpful to inform residency training programs to prepare psychiatrists for work in this emerging field of psychiatry.

Dose density in adjuvant chemotherapy for breast cancer.

PubMed

Citron, Marc L

2004-01-01

Dose-dense chemotherapy increases the dose intensity of the regimen by delivering standard-dose chemotherapy with shorter intervals between the cycles. This article discusses the rationale for dose-dense therapy and reviews the results with dose-dense adjuvant regimens in recent clinical trials in breast cancer. The papers for this review covered evidence of a dose-response relation in cancer chemotherapy; the rationale for dose-intense (and specifically dose-dense) therapy; and clinical experience with dose-dense regimens in adjuvant chemotherapy for breast cancer, with particular attention to outcomes and toxicity. Evidence supports maintaining the dose intensity of adjuvant chemotherapy within the conventional dose range. Disease-free and overall survival with combination cyclophosphamide, methotrexate, and fluorouracil are significantly improved when patients receive within 85% of the planned dose. Moderate and high dose cyclophosphamide, doxorubicin, and fluorouracil within the standard range results in greater disease-free and overall survival than the low dose regimen. The sequential addition of paclitaxel after concurrent doxorubicin and cyclophosphamide also significantly improves survival. Disease-free and overall survival with dose-dense sequential or concurrent doxorubicin, cyclophosphamide, and paclitaxel with filgrastim (rhG-CSF; NEUPOGEN) support are significantly greater than with conventional schedules (q21d). The delivered dose intensity of adjuvant chemotherapy within the standard dose range is an important predictor of the clinical outcome. Prospective trials of high-dose chemotherapy have shown no improvement over standard regimens, and toxicity was greater. Dose-dense adjuvant chemotherapy improves the clinical outcomes with doxorubicin-containing regimens. Filgrastim support enables the delivery of dose-dense chemotherapy and reduces the risk of neutropenia and its complications.

Checkpoint inhibitors in endometrial cancer: preclinical rationale and clinical activity.

PubMed

Mittica, Gloria; Ghisoni, Eleonora; Giannone, Gaia; Aglietta, Massimo; Genta, Sofia; Valabrega, Giorgio

2017-10-27

Treatment of advanced and recurrent endometrial cancer (EC) is still an unmet need for oncologists and gynecologic oncologists. The Cancer Genome Atlas Research Network (TCGA) recently provided a new genomic classification, dividing EC in four subgroups. Two types of EC, the polymerase epsilon (POLE)-ultra-mutated and the microsatellite instability-hyper-mutated (MSI-H), are characterized by a high mutation rate providing the rationale for a potential activity of checkpoint inhibitors. We analyzed all available evidence supporting the role of tumor microenvironment (TME) in EC development and the therapeutic implications offered by immune checkpoint inhibitors in this setting. We performed a review on Pubmed with Mesh keywords 'endometrial cancer' and the name of each checkpoint inhibitor discussed in the article. The same search was operated on clinicaltrial.gov to identify ongoing clinical trials exploring PD-1/PD-L1 and CTLA-4 axis in EC, particularly focusing on POLE-ultra-muted and MSI-H cancer types. POLE-ultra-mutated and MSI-H ECs showed an active TME expressing high number of neo-antigens and an elevated amount of tumor infiltrating lymphocytes (TILs). Preliminary results from a phase-1 clinical trial (KEYNOTE-028) demonstrated antitumor activity of Pembrolizumab in EC. Moreover, both Pembrolizumab and Nivolumab reported durable clinical responses in POLE-ultra-mutated patients. Immune checkpoint inhibitors are an attractive option in POLE-ultra-mutated and MSI-H ECs. Future investigations in these subgroups include combinations of checkpoints inhibitors with chemotherapy and small tyrosine kinase inhibitors (TKIs) to enhance a more robust intra-tumoral immune response.

Research Priorities in Spasmodic Dysphonia

PubMed Central

Ludlow, Christy L.; Adler, Charles H.; Berke, Gerald S.; Bielamowicz, Steven A.; Blitzer, Andrew; Bressman, Susan B.; Hallett, Mark; Jinnah, H. A.; Juergens, Uwe; Martin, Sandra B.; Perlmutter, Joel S.; Sapienza, Christine; Singleton, Andrew; Tanner, Caroline M.; Woodson, Gayle E.

2009-01-01

OBJECTIVE To identify research priorities for increasing understanding of the pathogenesis, diagnosis and improved treatment of spasmodic dysphonia. STUDY DESIGN AND SETTING A multidisciplinary working group was formed including both scientists and clinicians from multiple disciplines, otolaryngology, neurology, speech pathology, genetics and neuroscience, to review currently available information on spasmodic dysphonia and to identify research priorities. RESULTS Operational definitions for spasmodic dysphonia at different levels of certainty were recommended for diagnosis and recommendations made for a multi-center multidisciplinary validation study. CONCLUSIONS The highest priority is to characterize the disorder and identify risk factors that may contribute to its onset. Future research should compare and contrast spasmodic dysphonia with other forms of focal dystonia. Development of animal models is recommended to explore hypotheses related to pathogenesis. Improved understanding of the pathophysiology of SD should provide the basis for developing new treatment options and exploratory clinical trials. SIGNIFICANCE This document should foster future research to improve the care of patients with this chronic debilitating voice and speech disorder by otolaryngology, neurology, and speech pathology. PMID:18922334

Exploring the challenge of health research priority setting in partnership: reflections on the methodology used by the James Lind Alliance Pressure Ulcer Priority Setting Partnership.

PubMed

Madden, Mary; Morley, Richard

2016-01-01

The James Lind Alliance (JLA) brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs) to identify and prioritise shared uncertainties about the effects of treatment. The JLA emerged from the evidence-informed healthcare movement to address a concern that the research being carried out on treatment effectiveness is not that of most importance to patients and health professionals. In the JLA PSPs, 'hard' evidence-informed ideals meet 'soft' participatory practices. This article explores the challenges of putting co-production methods into practice by reflecting on the methods used by the JLA Pressure Ulcer PSP (JLAPUP). The JLA principles are transparency, inclusivity and avoiding waste in research. This means paying the same close critical attention to how PSPs are designed and run, as is desired in the health research which the JLA seeks to influence. JLAPUP showed that it was possible to work in partnership in a field where patients are often elderly, immobile, unrepresented and particularly unwell, many of whom are living with more than one long term condition. However, for those unfamiliar with it, 'uncertainty' was a difficult term to get to grips with. Also, it was harder for some people than others to take part and to have their voices heard and understood. In keeping with other PSPs, JLAPUP found that the nature and quality of research into pressure ulcer prevention and treatment did not reflect the priorities of those who took part. ᅟ. Studies identifying a mismatch between the priorities of academics and clinicians and those of people with direct experience of a health condition pose a challenge to the assumption that professional researchers can represent the interests of patients and the public in setting priorities for health research. The James Lind Alliance (JLA) brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs) to identify and prioritise shared uncertainties about the effects of treatment. There is no formal evaluation yet to examine the different approaches used by individual PSPs and the impact these methods have on the quality of the partnership and subsequent outputs. There is no gold standard method for health research topic identification and priority setting and reporting on public involvement in this area is predominantly descriptive rather than evaluative. The JLA Pressure Ulcer PSP (JLAPUP) was developed and worked between 2009 and 2013 to identify and prioritise the top 10 'uncertainties' , or 'unanswered questions', about the effects of pressure ulcer interventions. JLAPUP identified a mismatch between the nature and quality of RCTs in pressure ulcer prevention and treatment and the kind of research evidence desired by patients or service users, carers and health professionals. Results and methods have been reported fully elsewhere. The consultative and deliberative methods used to establish health research priorities in PSPs are fundamentally interpretive. PSPs are therefore an arena in which 'hard' evidence-informed ideals meet 'soft' participatory practices. This article provides an account of the challenges faced in one particular PSP. We explain the rationale for the approaches taken, difficulties faced and the limitations at each stage, because these aspects are particularly under-reported. The JLAPUP case is used to identify possible areas for evaluation and reporting across PSPs. Engaging people with very different health and life experiences in the complexities of health science based discussions of uncertainty is challenging. This is particularly the case when engaging groups routinely excluded from participating in health research, for example, older people with multiple comorbidities. The JLA principles of transparency, inclusivity and avoiding waste in research require paying close critical attention to PSP methodology, including full evaluation and reporting of PSP processes and outcomes. Assessing the impact of PSPs is contingent on the decision making processes of commissioners and funders.

Eliciting preferences for priority setting in genetic testing: a pilot study comparing best-worst scaling and discrete-choice experiments.

PubMed

Severin, Franziska; Schmidtke, Jörg; Mühlbacher, Axel; Rogowski, Wolf H

2013-11-01

Given the increasing number of genetic tests available, decisions have to be made on how to allocate limited health-care resources to them. Different criteria have been proposed to guide priority setting. However, their relative importance is unclear. Discrete-choice experiments (DCEs) and best-worst scaling experiments (BWSs) are methods used to identify and weight various criteria that influence orders of priority. This study tests whether these preference eliciting techniques can be used for prioritising genetic tests and compares the empirical findings resulting from these two approaches. Pilot DCE and BWS questionnaires were developed for the same criteria: prevalence, severity, clinical utility, alternatives to genetic testing available, infrastructure for testing and care established, and urgency of care. Interview-style experiments were carried out among different genetics professionals (mainly clinical geneticists, researchers and biologists). A total of 31 respondents completed the DCE and 26 completed the BWS experiment. Weights for the levels of the six attributes were estimated by conditional logit models. Although the results derived from the DCE and BWS experiments differed in detail, we found similar valuation patterns in the DCE and BWS experiments. The respondents attached greatest value to tests with high clinical utility (defined by the availability of treatments that reduce mortality and morbidity) and to testing for highly prevalent conditions. The findings from this study exemplify how decision makers can use quantitative preference eliciting methods to measure aggregated preferences in order to prioritise alternative clinical interventions. Further research is necessary to confirm the survey results.

3min. poster presentations of B01

NASA Astrophysics Data System (ADS)

Foing, Bernard H.

We give a report on recommendations from ILEWG International conferences held at Cape Canaveral in 2008 (ICEUM10), and in Beijing in May 2010 with IAF (GLUC -ICEUM11). We discuss the different rationale for Moon exploration. Priorities for scientific investigations include: clues on the formation and evolution of rocky planets, accretion and bombardment in the inner solar system, comparative planetology processes (tectonic, volcanic, impact cratering, volatile delivery), historical records, astrobiology, survival of organics; past, present and future life. The ILEWG technology task group set priorities for the advancement of instrumenta-tion: Remote sensing miniaturised instruments; Surface geophysical and geochemistry package; Instrument deployment and robotic arm, nano-rover, sampling, drilling; Sample finder and collector. Regional mobility rover; Autonomy and Navigation; Artificially intelligent robots, Complex systems. The ILEWG ExogeoLab pilot project was developed as support for instru-ments, landers, rovers,and preparation for cooperative robotic village. The ILEWG lunar base task group looked at minimal design concepts, technologies in robotic and human exploration with Tele control, telepresence, virtual reality; Man-Machine interface and performances. The ILEWG ExoHab pilot project has been started with support from agencies and partners. We discuss ILEWG terrestrial Moon-Mars campaigns for validation of technologies, research and human operations. We indicate how Moon-Mars Exploration can inspire solutions to global Earth sustained development: In-Situ Utilisation of resources; Establishment of permanent robotic infrastructures, Environmental protection aspects; Life sciences laboratories; Support to human exploration. Co-Authors: ILEWG Task Groups on: Science, Technology, Robotic village, Lunar Bases , Commercial and Societal aspects, Roadmap synergies with other programmes, Public en-gagemnet and Outreach, Young Lunar Explorers.

New developments in children's environmental health in Europe.

PubMed

Tamburlini, Giorgio

2006-09-01

Important developments have taken place in Europe regarding children's environmental health (CEH) over the last few years. In 1999 the Third Ministerial Conference on Environment and Health identified CEH as a priority area and started a process of scientific review and policy development that culminated at the Fourth Ministerial Conference held in Budapest in June 2004 with the adoption of the Children's Environment and Health Action Plan for Europe (CEHAPE). The rationale of the CEHAPE is based on a thorough review of the scientific evidence on CEH and on a study that quantified for the first time the burden of disease related to the main environmental exposures of children and adolescents in Europe. The Action Plan suggests actions and policies to achieve the four main priority goals: clean air, safe water, chemical and physical agents, and injuries. Over the same period, the European Commission (EC) has strengthened its focus on environment and health issues, has supported research on CEH, and has developed a proposal for a new EU regulatory framework for chemicals that has clear implications for children and for the reproductive period. The proposed new system, called REACH (Registration, Evaluation, and Authorization of Chemicals), currently under examination by the European Parliament, aims at reducing risks to human health and improvement of environmental quality through the better and earlier identification of the properties of chemical substances. The EC also adopted policies and action plans that are very relevant to children, such as the EU European Environment and Health Strategy, referred to as the SCALE initiative (Science, Children, Awareness, Legislation, Evaluation), and the 2004-2010 Environment and Health Action Plan.

Birds of a feather

USGS Publications Warehouse

Knick, Steven T.; Gondhaleker, Carmen

2014-01-01

Greater sage-grouse (Centrocercus urophasiunus, hereafter sage-grouse) are broadly distributed, occupy a diversity of sagebrush habitats, and face multiple threats. As a result of these threats, sage-grouse populations are declining and are now absent from almost one-half of their estimated range prior to Euro-American settlement. The risks to sage-grouse are significant enough to merit candidate status for this species for listing under the U.S. Endangered Species Act (Federal Register Notice, March 5, 2010). According to this decision by the U.S. Fish and Wildlife Service in 2010, population and habitat fragmentation coupled with lack of regulatory mechanisms warranted listing, although implementation of actions has been precluded by other priorities. Candidate status for listing under the Endangered Species Act and possible regulatory action in the near future provide strong motivation to better understand the dynamics of sage-grouse populations and their habitat requirements. The general approach currently taken by managers focuses on maintaining or enhancing sage-grouse populations across their distribution in regions containing the highest densities of breeding birds and their important seasonal habitats, also known as priority areas for conservation (PACs). The rationale behind this approach is that it permits limited resources to be applied in regions that have the greatest potential to benefit the largest proportion of sage-grouse. Development and other forms of land use can then proceed under standard regulations in areas outside PACs. Implementation of this approach requires detailed information about habitat, connections among sage-grouse populations, and approaches to restore and maintain sagebrush. These are important topics of study by the U.S. Geological Survey (USGS) and its research partners.

2015 revised Utstein-style recommended guidelines for uniform reporting of data from drowning-related resuscitation: An ILCOR advisory statement.

PubMed

Idris, Ahamed H; Bierens, Joost J L M; Perkins, Gavin D; Wenzel, Volker; Nadkarni, Vinay; Morley, Peter; Warner, David S; Topjian, Alexis; Venema, Allart M; Branche, Christine M; Szpilman, David; Morizot-Leite, Luiz; Nitta, Masahiko; Løfgren, Bo; Webber, Jonathon; Gräsner, Jan-Thorsten; Beerman, Stephen B; Youn, Chun Song; Jost, Ulrich; Quan, Linda; Dezfulian, Cameron; Handley, Anthony J; Hazinski, Mary Fran

2017-09-01

Utstein-style guidelines use an established consensus process, endorsed by the international resuscitation community, to facilitate and structure resuscitation research and publication. The first "Guidelines for Uniform Reporting of Data From Drowning" were published over a decade ago. During the intervening years, resuscitation science has advanced considerably, thus making revision of the guidelines timely. In particular, measurement of cardiopulmonary resuscitation elements and neurological outcomes reporting have advanced substantially. The purpose of this report is to provide updated guidelines for reporting data from studies of resuscitation from drowning. An international group with scientific expertise in the fields of drowning research, resuscitation research, emergency medical services, public health, and development of guidelines met in Potsdam, Germany, to determine the data that should be reported in scientific articles on the subject of resuscitation from drowning. At the Utstein-style meeting, participants discussed data elements in detail, defined the data, determined data priority, and decided how data should be reported, including scoring methods and category details. The template for reporting data from drowning research was revised extensively, with new emphasis on measurement of quality of resuscitation, neurological outcomes, and deletion of data that have proved to be less relevant or difficult to capture. The report describes the consensus process, rationale for selecting data elements to be reported, definitions and priority of data, and scoring methods. These guidelines are intended to improve the clarity of scientific communication and the comparability of scientific investigations. Copyright © 2017 European Resuscitation Council, American Heart Association, Inc. Published by Elsevier B.V. All rights reserved.

Radiopharmaceuticals in nuclear medicine practice

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

Kowalsky, R.J.; Perry, J.R.

1987-01-01

This book discusses the basic principles and clinical applications of radiopharmaceuticals. Topics include atomic physics as applied to radiopharmaceuticals, radionuclide generator function, nuclear pharmacy and safety, and radiopharmaceutical use in evaluating the major organ systems of the body. For each body system the author explains rationale for use, typical procedures, current agents of choice, and interpretation of results. Images, tables, and graphs illustrate normal and abnormal studies.

Consulting patients in setting priorities in Myalgic Encephalomyelitis (M.E.) research: findings from a national on-line survey.

PubMed

Childs, Nicola; Robinson, Lisa; Chowdhury, Sonya; Ogden, Clare; Newton, Julia L

2015-01-01

Myalgic encephalitis (M.E.) is a common condition, the cause of which is not known and there are no treatments available. In this study the national patient support group Action for M.E. sought the opinions of their members via an online survey as to what they felt should be future priorities for M.E. Respondents were asked what they considered first, second and third research priorities to be from a list of 13 pre-defined options. Individuals were invited to provide additional free text comments about Action for M.E.'s research priorities in general. Of the 1144 respondents: 822 had M.E.; 94 were a supporting a member of Action for M.E. ; 66 were carers for someone with M.E.; 26 were professionals with an interest in M.E.; 136 had a family member or colleague with M.E. Individuals selected more than one category as applicable. The top five research priorities identified were: disease processes to achieve a better understanding of the causes of M.E.; more effective treatments; faster and more accurate diagnosis; clinical course of M.E.; outcomes and natural history; and severely affected patients. Least popular priorities were: sleep; economic research towards identifying the cost of ME; and psychological aspects. Much of the free text comments emphasised the importance of funding biomedical research into disease processes to achieve a better understanding of the causes of M.E. Three themes were identified in relation to this topic: accurate diagnosis and awareness; risk factors and causes; drug development and curative therapies. In conclusion; individuals affected by M.E. have clear views regarding priorities for research investment. These have informed Action for M.E.'s ongoing research strategy and ultimately will inform national and international research priorities.

American Society of Clinical Oncology Obesity Initiative: Rationale, Progress, and Future Directions.

PubMed

Ligibel, Jennifer A; Wollins, Dana

2016-12-10

Obesity is increasingly being linked to the risk of developing and dying from cancer. In recognition of the growing contribution of obesity to cancer risk and outcomes, ASCO made obesity and cancer one of its core initiatives in 2014. The goals of this initiative included raising awareness of the relationship between obesity and cancer, providing tools and resources to oncology providers and patients to help encourage conversations regarding weight management in cancer survivors, fostering a robust research agenda, and advocating for access to evidence-based weight management programs for cancer survivors. Efforts to date have included developing patient and provider toolkits focused on weight management and physical activity, publishing a policy statement outlining ASCO's initiatives in this area, and hosting a summit focused on obesity research in cancer populations. As ASCO has defined its priorities in the area of obesity and cancer, it has become increasingly clear that obesity is a problem that extends far beyond its impact on cancer risk and outcomes. Many groups, including those focused on heart disease, diabetes, and endocrinology, have been developing, testing, and implementing obesity prevention and treatment strategies for years. As ASCO moves forward with its obesity initiative, the next steps will focus on forging collaboration with groups working on obesity-related initiatives both within and outside of the field of cancer to learn from their efforts and to partner with them on efforts to increase the education of medical professionals; raising awareness in lay populations regarding the negative health consequences of obesity and effective strategies to foster weight loss; developing collaborative research initiatives; and working together to advocate for the societal changes that will be needed to combat the obesity epidemic in the United States and beyond.

Hearts and minds.

PubMed

Naylor, A R

2012-01-01

The American Heart Association liberalised guidelines for carotid stenting (CAS) into average risk patients based on the following interpretations and assumptions; (i) CAS doubles the risk of procedural stroke; (ii) CEA doubles the risk of procedural myocardial infarction (MI); (iii) peri-operative MI significantly reduces long-term survival; (iv) poorer long-term survival is attributable to a greater proportion of CEA patients dying after their peri-operative MI. (v) reduced survival in CEA patients suffering a peri-operative MI offsets any benefit conferred by the lower procedural stroke risk so that; (vi) CAS is considered equivalent to CEA and may even be safer in those considered high risk for procedural MI. However, this much publicised rationale is flawed by the simple fact that the poorer survival rates observed in CREST were not attributable to a greater proportion of CEA patients dying following their procedural MI. In fact, a relatively higher proportion of CAS patients suffering a peri-operative MI died during follow-up. This observation changes how the literature should be interpreted. The clinical reality is that up to 10% of patients will suffer a stroke within seven days of their index TIA and the benefits of intervening in the hyperacute period after onset of symptoms (ie offering greater stroke prevention) will far outweigh any potential consequences of peri-operative MI and reduced life expectancy. Peri-operative MI should inform, but not drive the current debate. More importantly, it should not deflect attention away from the most important management priority; the prevention of stroke. This is one situation where the heart should not rule the head! Copyright © 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Effects of zolpidem alone and in combination with nabilone on cannabis withdrawal and a laboratory model of relapse in cannabis users

PubMed Central

Herrmann, Evan S.; Cooper, Ziva D.; Bedi, Gillinder; Ramesh, Divya; Reed, Stephanie C.; Comer, Sandra D.; Foltin, Richard W.; Haney, Margaret

2017-01-01

Rationale Each year over 300,000 individuals in the U.S. enter treatment for Cannabis Use Disorder (CUD). The development of effective pharmacotherapy for CUD is a priority. Objective This placebo-controlled study examined the effects of zolpidem alone and in combination with nabilone on cannabis withdrawal and a laboratory measure of relapse. Methods Eleven daily, non-treatment-seeking cannabis users completed three, 8-day inpatient phases; each phase tested a different medication condition in counter-balanced order. On the first day of each phase, participants were administered placebo capsules t.i.d. and smoked experimenter-administered active cannabis (5.6% THC). On days 2–8, participants were administered capsules containing either placebo (0 mg at 0900, 1800, and 2300), zolpidem (0 mg at 0900 and 1800 and 12.5 mg at 2300) or zolpidem (12.5 mg at 2300) and nabilone (3 mg at 0900 and 1800). Cannabis withdrawal, subjective capsule effects, and cognitive performance were examined on days 3–4, when only inactive cannabis (0.0% THC) was available for self-administration. ‘Relapse’ was measured on days 5–8, when participants could self-administer active cannabis. Results Both medication conditions decreased withdrawal-related disruptions in sleep, but only zolpidem in combination with nabilone decreased withdrawal-related disruptions in mood and food intake relative to placebo. Zolpidem in combination with nabilone, but not zolpidem alone, decreased self-administration of active cannabis. Zolpidem in combination with nabilone also produced small increases in certain abuse-related subjective capsule ratings, while zolpidem alone did not. Neither medication condition altered cognitive performance. Conclusions Clinical testing of nabilone, either alone, or in combination with zolpidem is warranted. PMID:27085870

Working to improve the management of sarcoma patients across Europe: a policy checklist.

PubMed

Kasper, Bernd; Lecointe-Artzner, Estelle; Wait, Suzanne; Boldon, Shannon; Wilson, Roger; Gronchi, Alessandro; Valverde, Claudia; Eriksson, Mikael; Dumont, Sarah; Drove, Nora; Kanli, Athanasia; Wartenberg, Markus

2018-04-16

The Sarcoma Policy Checklist was created by a multidisciplinary expert group to provide policymakers with priority areas to improve care for sarcoma patients. This paper draws on this research, by looking more closely at how France, Germany, Italy, Spain, Sweden and the United Kingdom are addressing each of these priority areas. It aims to highlight key gaps in research, policy and practice, as well as ongoing initiatives that may impact the future care of sarcoma patients in different European countries. A pragmatic review of the published and web-based literature was undertaken. Telephone interviews were conducted in each country with clinical and patient experts to substantiate findings. Research findings were discussed within the expert group and developed into five core policy recommendations. The five identified priority areas were: the development of designated and accredited centres of reference; more professional training; multidisciplinary care; greater incentives for research and innovation; and more rapid access to effective treatments. Most of the countries studied have ongoing initiatives addressing many of these priorities; however, many are in early stages of development, or require additional funding and resources. Gaps in access to quality care are particularly concerning in many of Europe's lower-resourced countries. Equitable access to information, clinical trials, innovative treatments and quality specialist care should be available to all sarcoma patients. Achieving this across Europe will require close collaboration between all stakeholders at both the national and European level.

Priority issues for pressure injury research: An Australian consensus study.

PubMed

Haesler, Emily; Carville, Keryln; Haesler, Paul

2018-06-08

Pressure injuries are a significant health concern in all clinical settings. The current body of research on pressure injuries reported in the literature presents primarily low level evidence. The purpose of the current study was to identify and prioritize pressure injury research issues. The approach entailed evidence scoping and implementing a formal consensus process using a modified nominal group technique based on the Research and Development/University of California at Los Angeles appropriateness method. Sixteen Australian pressure injury experts participated in five consensus voting rounds in May to June 2015. From 60 initial research issues, the experts reached agreement that 26 issues are a priority for future pressure injury research. The highest priorities were strategies to assess skin and tissues, appropriate outcome measures for indicators of pressure injury healing and recurrence, heel pressure off-loading and shear reduction strategies, economic cost of pressure injuries and their management and effectiveness of skin moisturizers and barrier products. Developing a prioritized research agenda, informed by clinical and academic pressure injury experts, can assist in reducing the burden of pressure injuries by identifying topics of the highest need for further research. A web-based nominal group voting process was successful in engaging expert decision-making and has wide-reaching international appeal in facilitating cost-effective consensus methodologies. The priority list generated from this research is currently used in Australia to inform government investment in pressure injury research. © 2018 Wiley Periodicals, Inc.

An American Thoracic Society Official Research Statement: Future Directions in Lung Fibrosis Research.

PubMed

White, Eric S; Borok, Zea; Brown, Kevin K; Eickelberg, Oliver; Guenther, Andreas; Jenkins, R Gisli; Kolb, Martin; Martinez, Fernando J; Roman, Jesse; Sime, Patricia

2016-04-01

Pulmonary fibrosis encompasses a group of lung-scarring disorders that occur owing to known or unknown insults and accounts for significant morbidity and mortality. Despite intense investigation spanning decades, much remains to be learned about the natural history, pathophysiology, and biologic mechanisms of disease. To identify the most pressing research needs in the lung fibrosis community and to provide a roadmap of priorities to investigators, funding agencies, patient advocacy groups, and other interested stakeholders. An ad hoc international working group of the American Thoracic Society with experience in clinical, translational, and bench-based research in fibrotic lung diseases was convened. The group used an iterative consensus process to identify successes and challenges in pulmonary fibrosis research. The group identified five main priority areas in which substantial resources should be invested to advance our understanding and to develop novel therapies for patients with pulmonary fibrosis. These priorities include develop newer models of human lung fibrosis, engage current and new stakeholders to provide sustained funding for the initiatives, create a global infrastructure for storing patient-derived materials, establish collaborative preclinical and clinical research networks in fibrotic lung disease, and create a global lung fibrosis initiative that unites these multifaceted efforts into a single virtual umbrella structure. Despite recent advances in the treatment of some forms of lung fibrosis, many gaps in knowledge about natural history, pathophysiology, and treatment remain. Investment in the research priorities enumerated above will help address these shortcomings and enhance patient care worldwide.

Teaching Economics to Young Adolescents: A Research-Based Rationale.

ERIC Educational Resources Information Center

Davis, James E.

This booklet presents a research-based rationale for teaching economics at the middle/junior high school level in the United States. Chapter 1, "Introduction," describes the project in which the rationale was developed and outlines the remainder of the document. Chapter 2, "Elements of a Rationale for Middle School Economic Education," presents…

The credibility of exposure therapy: Does the theoretical rationale matter?

PubMed

Arch, Joanna J; Twohig, Michael P; Deacon, Brett J; Landy, Lauren N; Bluett, Ellen J

2015-09-01

Little is understood about how the public perceives exposure-based therapy (ET) for treating anxiety and trauma-related disorders or how ET rationales affect treatment credibility. Distinct approaches to framing ET are practiced, including those emphasized in traditional cognitive behavioral therapy, acceptance and commitment therapy, and the more recent inhibitory learning model. However, their relative effect on ET's credibility remains unknown. A final sample of 964 U.S. adults provided baseline views of ET. Participants rated ET treatment credibility following a simple ET definition (pre-rationale) and following randomization to rationale modules addressing ET goals, fear, and cognitive strategies from distinct theoretical perspectives (post-rationale). Baseline ET views, symptoms, and sociodemographic characteristics were examined as putative moderators and predictors. At baseline, the majority had never heard of ET. From pre- to post-rationale, ET treatment credibility significantly increased but the rationales' theoretical perspective had little impact. More negative baseline ET views, specific ethnic/racial minority group status, and lower education moderated or predicted greater increases in treatment credibility following the rationale. ET remains relatively unknown as a treatment for anxiety or trauma, supporting the need for direct-to-consumer marketing. Diverse theory-driven rationales similarly increased ET credibility, particularly among those less likely to use ET. Copyright © 2015 Elsevier Ltd. All rights reserved.

Analysis of Nursing Clinical Decision Support Requests and Strategic Plan in a Large Academic Health System

PubMed Central

Bavuso, Karen; Bouyer-Ferullo, Sharon; Goldsmith, Denise; Fairbanks, Amanda; Gesner, Emily; Lagor, Charles; Collins, Sarah

2016-01-01

Summary Objectives To understand requests for nursing Clinical Decision Support (CDS) interventions at a large integrated health system undergoing vendor-based EHR implementation. In addition, to establish a process to guide both short-term implementation and long-term strategic goals to meet nursing CDS needs. Materials and Methods We conducted an environmental scan to understand current state of nursing CDS over three months. The environmental scan consisted of a literature review and an analysis of CDS requests received from across our health system. We identified existing high priority CDS and paper-based tools used in nursing practice at our health system that guide decision-making. Results A total of 46 nursing CDS requests were received. Fifty-six percent (n=26) were specific to a clinical specialty; 22 percent (n=10) were focused on facilitating clinical consults in the inpatient setting. “Risk Assessments/Risk Reduction/Promotion of Healthy Habits” (n=23) was the most requested High Priority Category received for nursing CDS. A continuum of types of nursing CDS needs emerged using the Data-Information-Knowledge-Wisdom Conceptual Framework: 1) facilitating data capture, 2) meeting information needs, 3) guiding knowledge-based decision making, and 4) exposing analytics for wisdom-based clinical interpretation by the nurse. Conclusion Identifying and prioritizing paper-based tools that can be modified into electronic CDS is a challenge. CDS strategy is an evolving process that relies on close collaboration and engagement with clinical sites for short-term implementation and should be incorporated into a long-term strategic plan that can be optimized and achieved overtime. The Data-Information-Knowledge-Wisdom Conceptual Framework in conjunction with the High Priority Categories established may be a useful tool to guide a strategic approach for meeting short-term nursing CDS needs and aligning with the organizational strategic plan. PMID:27437036

Setting a research agenda for progressive multiple sclerosis: the International Collaborative on Progressive MS.

PubMed

Fox, Robert J; Thompson, Alan; Baker, David; Baneke, Peer; Brown, Doug; Browne, Paul; Chandraratna, Dhia; Ciccarelli, Olga; Coetzee, Timothy; Comi, Giancarlo; Feinstein, Anthony; Kapoor, Raj; Lee, Karen; Salvetti, Marco; Sharrock, Kersten; Toosy, Ahmed; Zaratin, Paola; Zuidwijk, Kim

2012-11-01

Despite significant progress in the development of therapies for relapsing MS, progressive MS remains comparatively disappointing. Our objective, in this paper, is to review the current challenges in developing therapies for progressive MS and identify key priority areas for research. A collaborative was convened by volunteer and staff leaders from several MS societies with the mission to expedite the development of effective disease-modifying and symptom management therapies for progressive forms of multiple sclerosis. Through a series of scientific and strategic planning meetings, the collaborative identified and developed new perspectives on five key priority areas for research: experimental models, identification and validation of targets and repurposing opportunities, proof-of-concept clinical trial strategies, clinical outcome measures, and symptom management and rehabilitation. Our conclusions, tackling the impediments in developing therapies for progressive MS will require an integrated, multi-disciplinary approach to enable effective translation of research into therapies for progressive MS. Engagement of the MS research community through an international effort is needed to address and fund these research priorities with the ultimate goal of expediting the development of disease-modifying and symptom-relief treatments for progressive MS.

The perceived urgency of auditory warning alarms used in the hospital operating room is inappropriate.

PubMed

Mondor, Todd A; Finley, G Allen

2003-03-01

To examine the perceived urgency of 13 auditory warning alarms commonly occurring in the hospital operating room. Undergraduate students, who were naïve with respect to the clinical situation associated with the alarms, judged perceived urgency of each alarm on a ten-point scale. The perceived urgency of the alarms was not consistent with the actual urgency of the clinical situation that triggers it. In addition, those alarms indicating patient condition were generally perceived as less urgent than those alarms indicating the operation of equipment. Of particular interest were three sets of alarms designed by equipment manufacturers to indicate specific priorities for action. Listeners did not perceive any differences in the urgency of the 'information only', 'medium' and 'high' priority alarms of two of the monitors with all judged as low to moderate in urgency. In contrast, the high priority alarm of the third monitor was judged as significantly more urgent than its low and medium urgency counterparts. The alarms currently in use do not convey the intended sense of urgency to naïve listeners, and this holds even for two sets of alarms designed specifically by manufacturers to convey different levels of urgency.

Setting a research agenda for progressive multiple sclerosis: The International Collaborative on Progressive MS

PubMed Central

Thompson, Alan; Baker, David; Baneke, Peer; Brown, Doug; Browne, Paul; Chandraratna, Dhia; Ciccarelli, Olga; Coetzee, Timothy; Comi, Giancarlo; Feinstein, Anthony; Kapoor, Raj; Lee, Karen; Salvetti, Marco; Sharrock, Kersten; Toosy, Ahmed; Zaratin, Paola; Zuidwijk, Kim

2012-01-01

Despite significant progress in the development of therapies for relapsing MS, progressive MS remains comparatively disappointing. Our objective, in this paper, is to review the current challenges in developing therapies for progressive MS and identify key priority areas for research. A collaborative was convened by volunteer and staff leaders from several MS societies with the mission to expedite the development of effective disease-modifying and symptom management therapies for progressive forms of multiple sclerosis. Through a series of scientific and strategic planning meetings, the collaborative identified and developed new perspectives on five key priority areas for research: experimental models, identification and validation of targets and repurposing opportunities, proof-of-concept clinical trial strategies, clinical outcome measures, and symptom management and rehabilitation. Our conclusions, tackling the impediments in developing therapies for progressive MS will require an integrated, multi-disciplinary approach to enable effective translation of research into therapies for progressive MS. Engagement of the MS research community through an international effort is needed to address and fund these research priorities with the ultimate goal of expediting the development of disease-modifying and symptom-relief treatments for progressive MS. PMID:22917690

Mycoplasma genitalium From Basic Science to Public Health: Summary of the Results From a National Institute of Allergy and Infectious Disesases Technical Consultation and Consensus Recommendations for Future Research Priorities.

PubMed

Martin, David H; Manhart, Lisa E; Workowski, Kimberly A

2017-07-15

This article lays out the research priorities for Mycoplasma genitalium research agreed upon by the participants in a 2016 National Institutes of Allergy and Infectious Diseases-funded Technical Consultation focused on this organism. The state of current knowledge concerning the microbiology, epidemiology, clinical manifestations of infection, treatment, and public health significance of M. genitalium reviewed at the meeting is described in detail in the individual articles included in this supplemental edition of the Journal of Infectious Diseases. Here we summarize the points made in these articles most relevant to the formulation of the research priorities listed in this article. The most important recommendation resulting from this Technical Consultation is the initiation of clinical trials designed to determine definitively whether screening for and treatment of M. genitalium infections in women and their sexual partners improve reproductive health in women and/or prevent human immunodeficiency virus transmission. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Tracing Spasmodic Dysphonia: The Source of Ludwig Traube's Priority.

PubMed

Lorch, Marjorie Perlman; Whurr, Renata

2016-08-01

Since the mid-20th century, one citation is given historical priority as the first description of spasmodic dysphonia (SD): Ludwig Traube's 1871 case of the "spastic form of nervous hoarseness." Our objective is to understand how this case serves as the foundation of understanding laryngeal movement disorders. The original German paper was located and translated. Bibliographical and bibliometric methods are used to determine the citation history of this original source over the past 140 years. Although secondary citations in contemporary publications typically credit Traube for establishing the clinical entity SD, his case does not conform to currently accepted diagnostic features. Citation patterns indicate the source of Traube's priority is publications by Arnold and Luchsinger, mid-20th-century ENT clinicians, particularly their influential 1965 textbook used to train US and UK clinicians on voice disorders for several generations. Sometimes secondary citations in medical literature lead to the inadvertent perpetuation of factual misrepresentation. The clinical picture of Traube's original case does not represent what clinicians would recognize as SD today. The rich 19th-century literature on voice disorders is a valuable resource for present day clinicians. © The Author(s) 2016.

NeuroMind: Past, present, and future.

PubMed

Kubben, Pieter L

2017-01-01

This narrative report describes the underlying rationale and technical developments of NeuroMind, a mobile clinical decision support system for neurosurgery. From the perspective of a neurosurgeon - (app) developer it explains how technical progress has shaped the world's "most rated and highest rated" neurosurgical mobile application, with particular attention for operating system diversity on mobile hardware, cookbook medicine, regulatory affairs (in particular regarding software as a medical device), and new developments in the field of clinical data science, machine learning, and predictive analytics. Finally, the concept of "computational neurosurgery" is introduced as a vehicle to reach new horizons in neurosurgery.

Photodynamic therapy in treatment of severe oral lichen planus.

PubMed

Rabinovich, O F; Rabinovich, I M; Guseva, A V

2016-01-01

The aim of the study was to elaborate the rationale for the application of photodynamic therapy in complex treatment of patient with severe oral lichen planus. Complex clinical and laboratory examination and treatment was performed in 54 patients divided on 3 groups. Diagnosis of oral lichen planus was based on clinical, histological and immunohistochemical features. Group 1 received standard treatment, in the second group photodynamic therapy was conducted in addition to conventional treatment, patients in the third group received only photodynamic therapy. The study results proved photodynamic therapy to be useful tool in complex treatment of severe oral lichen planus.

Evaluation of nursing practice: process and critique.

PubMed

Braunstein, M S

1998-01-01

This article describes the difficulties in conducting clinical trials to evaluate nursing practice models. Suggestions are offered for strengthening the process. A clinical trial of a nursing practice model based on a synthesis of Aristotelian theory with Rogers' science is described. The rationale for decisions regarding the research procedures used in presented. Methodological limitations of the study design and the specifications of the practice model are examined. It is concluded that clear specification of theoretical relationships within a practice model and clear identification of key intervening variables will enable researchers to better connect the treatment with the outcome.

NeuroMind: Past, present, and future

PubMed Central

Kubben, Pieter L.

2017-01-01

This narrative report describes the underlying rationale and technical developments of NeuroMind, a mobile clinical decision support system for neurosurgery. From the perspective of a neurosurgeon – (app) developer it explains how technical progress has shaped the world's “most rated and highest rated” neurosurgical mobile application, with particular attention for operating system diversity on mobile hardware, cookbook medicine, regulatory affairs (in particular regarding software as a medical device), and new developments in the field of clinical data science, machine learning, and predictive analytics. Finally, the concept of “computational neurosurgery” is introduced as a vehicle to reach new horizons in neurosurgery. PMID:28966822

The Edwin Smith papyrus: a clinical reappraisal of the oldest known document on spinal injuries

PubMed Central

Sanchez, Gonzalo M.; Burridge, Alwyn L.

2010-01-01

Dating from the seventeenth century b.c. the Edwin Smith papyrus is a unique treatise containing the oldest known descriptions of signs and symptoms of injuries of the spinal column and spinal cord. Based on a recent “medically based translation” of the Smith papyrus, its enclosed treasures in diagnostic, prognostic and therapeutic reasoning are revisited. Although patient demographics, diagnostic techniques and therapeutic options considerably changed over time, the documented rationale on spinal injuries can still be regarded as the state-of-the-art reasoning for modern clinical practice. PMID:20697750

A modified tensionless gingival grafting technique using acellular dermal matrix.

PubMed

Taylor, John B; Gerlach, Robert C; Herold, Robert W; Bisch, Frederick C; Dixon, Douglas R

2010-10-01

Conventional surgical procedures designed for autogenous tissue material may not be appropriate when using acellular dermal matrix (ADM) for the treatment of gingival recessions. This article describes a new surgical technique that addresses the unique and sensitive aspects of ADM specifically to improve esthetic outcomes and gain increased clinical predictability when treating Miller Class I and II gingival recession defects. In this paper, a root coverage case is described and the specific steps and rationale for this new technique are explained. This technique has been predictable clinically, with results comparable to those achieved using autogenous tissue.

Effects of Providing a Rationale for Learning a Lesson on Students' Motivation and Learning in Online Learning Environments

ERIC Educational Resources Information Center

Shin, Tae Seob

2010-01-01

This study examined whether providing a rationale for learning a particular lesson influences students' motivation and learning in online learning environments. A mixed-method design was used to investigate the effects of two types of rationales (former student vs. instructor rationales) presented in an online introductory educational psychology…

Why Do Higher Education Institutions Internationalize? An Investigation of the Multilevel Determinants of Internationalization Rationales

ERIC Educational Resources Information Center

Seeber, Marco; Cattaneo, Mattia; Huisman, Jeroen; Paleari, Stefano

2016-01-01

In recent decades internationalization has risen to prominence in higher education institutions (HEIs). Scholars have identified several rationales for internationalization. There is however a lack of conceptual understanding and empirical evidence for which rationale(s) for internationalization are chosen by a given HEI and why. The goal of this…

Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange.

PubMed

Agiostratidou, Gina; Anhalt, Henry; Ball, Dana; Blonde, Lawrence; Gourgari, Evgenia; Harriman, Karen N; Kowalski, Aaron J; Madden, Paul; McAuliffe-Fogarty, Alicia H; McElwee-Malloy, Molly; Peters, Anne; Raman, Sripriya; Reifschneider, Kent; Rubin, Karen; Weinzimer, Stuart A

2017-12-01

To identify and define clinically meaningful type 1 diabetes outcomes beyond hemoglobin A 1c (HbA 1c ) based upon a review of the evidence, consensus from clinical experts, and input from researchers, people with type 1 diabetes, and industry. Priority outcomes include hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). While priority outcomes for type 1 and type 2 diabetes may overlap, type 1 diabetes was the focus of this work. A Steering Committee-comprising representatives from the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange-was the decision-making body for the Type 1 Diabetes Outcomes Program. Their work was informed by input from researchers, industry, and people with diabetes through Advisory Committees representing each stakeholder group. Stakeholder surveys were used to identify priority outcomes. The outcomes prioritized in the surveys were hypoglycemia, hyperglycemia, time in range, DKA, and PROs. To develop consensus on the definitions of these outcomes, the Steering Committee relied on published evidence, their clinical expertise, and feedback from the Advisory Committees. The Steering Committee developed definitions for hypoglycemia, hyperglycemia, time in range, and DKA in type 1 diabetes. The definitions reflect their assessment of the outcome's short- and long-term clinical impact on people with type 1 diabetes. Knowledge gaps to be addressed by future research were identified. The Steering Committee discussed PROs and concluded that further type 1 diabetes-specific development is needed. The Steering Committee recommends use of the defined clinically meaningful outcomes beyond HbA 1c in the research, development, and evaluation of type 1 diabetes therapies. © 2017 by the American Diabetes Association.

Evaluation of evidence-based literature and formulation of recommendations for the clinical preventive guidelines for immigrants and refugees in Canada

PubMed Central

Tugwell, Peter; Pottie, Kevin; Welch, Vivian; Ueffing, Erin; Chambers, Andrea; Feightner, John

2011-01-01

Background: This article describes the evidence review and guideline development method developed for the Clinical Preventive Guidelines for Immigrants and Refugees in Canada by the Canadian Collaboration for Immigrant and Refugee Health Guideline Committee. Methods: The Appraisal of Guidelines for Research and Evaluation (AGREE) best-practice framework was combined with the recently developed Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to produce evidence-based clinical guidelines for immigrants and refugees in Canada. Results: A systematic approach was designed to produce the evidence reviews and apply the GRADE approach, including building on evidence from previous systematic reviews, searching for and comparing evidence between general and specific immigrant populations, and applying the GRADE criteria for making recommendations. This method was used for priority health conditions that had been selected by practitioners caring for immigrants and refugees in Canada. Interpretation: This article outlines the 14-step method that was defined to standardize the guideline development process for each priority health condition. PMID:20573711

Engaging Patients and Clinicians in Establishing Research Priorities for Gestational Diabetes Mellitus.

PubMed

Rees, Sandra E; Chadha, Rati; Donovan, Lois E; Guitard, Adrienne L T; Koppula, Sudha; Laupacis, Andreas; Simpson, Sara; Johnson, Jeffrey A

2017-04-01

We involved patients and clinicians in Alberta, Canada, to establish research priorities in gestational diabetes mellitus (GDM), using an approach based on a model proposed by the James Lind Alliance (JLA). We adapted the 4-step JLA process to engage women with GDM and clinicians to identify uncertainties about the management of GDM. Uncertainties were identified through a survey and a review of the clinical practice guidelines (CPG). Uncertainties were short-listed by a steering committee, followed by a 1-day facilitated workshop using a nominal group format and involving a similar number of patients and clinicians, who identified the top 10 research priorities. Across the various survey formats, 75 individuals submitted 389 uncertainties, the majority (44; 59%) coming from patients. We removed 9 questions as being out of scope or unclear, and 41 were identified on a review of CPG, resulting in a total of 421 uncertainties. After the priority setting process, the final top 10 research priorities included questions about a simpler, more accurate and convenient screening test; risk factors for GDM; improving postpartum diabetes screening; the impact of GDM on the future health of the children; lifestyle challenges and mental health issues; safety, effectiveness and/or impact of diet and/or medication treatments; appropriate timing for delivery; and how care is provided, organized or communicated. These top 10 research priorities were informed through a comprehensive and transparent process involving women who have experienced GDM as well as clinicians, and they may be regarded as research priorities for GDM. Copyright © 2016 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study.

PubMed

Ielasi, Alfonso; Varricchio, Attilio; Campo, Gianluca; Leoncini, Massimo; Cortese, Bernardo; Vicinelli, Paolo; Brugaletta, Salvatore; di Uccio, Fortunato Scotto; Latib, Azeem; Tespili, Maurizio

2017-06-01

To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events. This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781. The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up. This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Advance Care Planning: Understanding Clinical Routines and Experiences of Interprofessional Team Members in Diverse Health Care Settings.

PubMed

Arnett, Kelly; Sudore, Rebecca L; Nowels, David; Feng, Cindy X; Levy, Cari R; Lum, Hillary D

2017-12-01

Interprofessional health care team members consider advance care planning (ACP) to be important, yet gaps remain in systematic clinical routines to support ACP. A clearer understanding of the interprofessional team members' perspectives on ACP clinical routines in diverse settings is needed. One hundred eighteen health care team members from community-based clinics, long-term care facilities, academic clinics, federally qualified health centers, and hospitals participated in a 35-question, cross-sectional online survey to assess clinical routines, workflow processes, and policies relating to ACP. Respondents were 53% physicians, 18% advanced practice nurses, 11% nurses, and 18% other interprofessional team members including administrators, chaplains, social workers, and others. Regarding clinical routines, respondents reported that several interprofessional team members play a role in facilitating ACP (ie, physician, social worker, nurse, others). Most (62%) settings did not have, or did not know of, policies related to ACP documentation. Only 14% of settings had a patient education program. Two-thirds of the respondents said that addressing ACP is a high priority and 85% felt that nonphysicians could have ACP conversations with appropriate training. The clinical resources needed to improve clinical routines included training for providers and staff, dedicated staff to facilitate ACP, and availability of patient/family educational materials. Although interprofessional health care team members consider ACP a priority and several team members may be involved, clinical settings lack systematic clinical routines to support ACP. Patient educational materials, interprofessional team training, and policies to support ACP clinical workflows that do not rely solely on physicians could improve ACP across diverse clinical settings.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction.

PubMed

Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

2017-01-01

This series of articles, Standards for Clinical Trials in Male and Female Sexual Dysfunction, began with the discussion of a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for the selection of study population and study duration in male and female sexual dysfunction. The second article in this series discussed fundamental principles in development, validation, and selection of patient- (and partner-) reported outcome assessment. The third and present article in this series discusses selected aspects of sexual dysfunction that are that are unique to male sexual dysfunctions and relevant to the conduct of clinical trials of candidate treatments for men. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Clinical development of CT-P10 and other biosimilar cancer therapeutics.

PubMed

Kim, Won Seog; Coiffier, Bertrand; Kwon, Hyuk-Chan; Kim, SuYeon

2017-05-01

Biosimilars are highly similar versions of approved biologic drugs that may confer equivalent efficacy at a reduced cost. Patents for several biological cancer therapeutics are past or approaching expiry, presenting an opportunity to increase affordability and global accessibility of key drugs through the development of biosimilars. To receive approval, a biosimilar must show no clinically meaningful differences from the reference product in terms of efficacy or safety. The first monoclonal antibody biosimilar cancer therapeutic to gain approval was CT-P10, a biosimilar of rituximab. Here, we review the oncology clinical development program for CT-P10, providing insights into the rationale for, and design of, CT-P10 clinical trials in patients with cancer. Trials of biosimilar cancer therapeutics in development are also discussed.

Technical standards and guidelines: molecular genetic testing for ultra-rare disorders.

PubMed

Maddalena, Anne; Bale, Sherri; Das, Soma; Grody, Wayne; Richards, Sue

2005-10-01

These standards and guidelines are designed primarily as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These standards and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the clinical molecular geneticist should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the laboratory record the rationale for any significant deviation from these standards and guidelines.

Clinical Uncertainties, Health Service Challenges, and Ethical Complexities of HIV “Test-and-Treat”: A Systematic Review

PubMed Central

Shah, Kavita R.; Sarma, Karthik V.; Mahajan, Anish P.

2013-01-01

Despite the HIV “test-and-treat” strategy’s promise, questions about its clinical rationale, operational feasibility, and ethical appropriateness have led to vigorous debate in the global HIV community. We performed a systematic review of the literature published between January 2009 and May 2012 using PubMed, SCOPUS, Global Health, Web of Science, BIOSIS, Cochrane CENTRAL, EBSCO Africa-Wide Information, and EBSCO CINAHL Plus databases to summarize clinical uncertainties, health service challenges, and ethical complexities that may affect the test-and-treat strategy’s success. A thoughtful approach to research and implementation to address clinical and health service questions and meaningful community engagement regarding ethical complexities may bring us closer to safe, feasible, and effective test-and-treat implementation. PMID:23597344

[30 years since the first AIDS cases were reported: history and the present. Part I].

PubMed

Brůcková, Marie

2012-05-01

The 30-year natural history of AIDS disease is presented from the first clinical cases reported in 1981 to the identification of the HIV as the etiological agent of the disease. The priority dispute between Robert C. Gallo and Luc Montagnier over the discovery of the human immunodeficiency virus is briefly addressed. The final confirmation of the French priority was provided by the fact that the Nobel Prize in Medicine 2008 was awarded to Luc Montagnier and Francoise Barré--Sinoussi from the Pasteur Institute in Paris.

Coherent exchange of healthcare knowledge in open systems.

PubMed

Buchan, I; Hanka, R

1997-01-01

This paper outlines design philosophies and methods for healthcare knowledge systems. Clinical priorities for knowledge are discussed in terms of temporal and individual needs. Book centred organisation of healthcare knowledge, which has proven effective in clinical practice, is proposed as the basis of virtual libraries available at the point of care for target groups of healthcare professionals.

Ontology-Based Data Integration of Open Source Electronic Medical Record and Data Capture Systems

ERIC Educational Resources Information Center

Guidry, Alicia F.

2013-01-01

In low-resource settings, the prioritization of clinical care funding is often determined by immediate health priorities. As a result, investment directed towards the development of standards for clinical data representation and exchange are rare and accordingly, data management systems are often redundant. Open-source systems such as OpenMRS and…

Extracorporeal carbon dioxide removal in acute exacerbations of chronic obstructive pulmonary disease

PubMed Central

Pettenuzzo, Tommaso; Fan, Eddy

2018-01-01

Extracorporeal carbon dioxide removal (ECCO2R) has been proposed as an adjunctive intervention to avoid worsening respiratory acidosis, thereby preventing or shortening the duration of invasive mechanical ventilation (IMV) in patients with exacerbation of chronic obstructive pulmonary disease (COPD). This review will present a comprehensive summary of the pathophysiological rationale and clinical evidence of ECCO2R in patients suffering from severe COPD exacerbations. PMID:29430448

Attachment-based family therapy interventions.

PubMed

Diamond, Gary M

2014-03-01

Attachment-Based Family Therapy is a treatment model designed specifically for depressed and suicidal adolescents. The primary goal of the treatment is to promote developmentally appropriate adolescent-parent attachment. Three core interventions are discussed: relational reframes; focusing on primary emotions and unmet attachment needs; and facilitating corrective attachment episodes. For each intervention, the theoretical/clinical rationale is presented followed by a brief illustration and relevant research findings. (c) 2014 APA, all rights reserved.

Fibroepithelial polyp in a child.

PubMed

Mydlo, J; Reda, E; Gill, B; Kogan, S J; Ziprkowski, M N; Weiss, R; Levitt, S B

1988-04-01

Only 15 cases of fibroepithelial polyp in children have been reported in the world medical literature. Clinical differentiation between this tumor and a malignant ureteral tumor is difficult and often results in unnecessary nephrectomy. We report the sixteenth case of a child with fibroepithelial polyp of the ureter. The lesion was resected, and the kidney was preserved. Optimum treatment of this lesion mandates renal preservation in children. The rationale for this recommendation is explored.

An evidence-based systematic review of elderberry and elderflower (Sambucus nigra) by the Natural Standard Research Collaboration.

PubMed

Ulbricht, Catherine; Basch, Ethan; Cheung, Lisa; Goldberg, Harley; Hammerness, Paul; Isaac, Richard; Khalsa, Karta Purkh Singh; Romm, Aviva; Rychlik, Idalia; Varghese, Minney; Weissner, Wendy; Windsor, Regina C; Wortley, Jayme

2014-03-01

An evidence-based systematic review of elderberry and elderflower (Sambucus nigra) by the Natural Standard Research Collaboration consolidates the safety and efficacy data available in the scientific literature using a validated, reproducible grading rationale. This article includes written and statistical analysis of clinical trials, plus a compilation of expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

Client cognitive responses to counselor paradoxical and nonparadoxical directives.

PubMed

Lee, D Y; Rossiter, B; Martin, J; Uhlemann, M R

1990-09-01

Client cognitive responses to counselor paradoxical and nonparadoxical directives were examined. It was predicted (a) that clients who received paradoxical symptom prescriptions would display a greater negativity toward the counselor and counseling than those who received nonparadoxical directives; and (b) that clients who received no rationale for the paradoxical directives would display a greater negativity than those who received a rationale. Thirty clients who had reported performance anxiety received one 45-minute counseling interview. Ten clients received paradoxical directives with a rationale, 10 received paradoxical directives with no rationale, and 10 received nonparadoxical directives. Results showed no significant differences in either client in-session negativity or out-of-session implementation of directives between the paradoxical and nonparadoxical conditions and between the rationale and no rationale paradoxical conditions. Possible implications of the findings are discussed.

Rationale for Developing a Specimen Bank to Study the Pathogenesis of High-Grade Serous Carcinoma: A Review of the Evidence.

PubMed

Sherman, Mark E; Drapkin, Ronny I; Horowitz, Neil S; Crum, Christopher P; Friedman, Sue; Kwon, Janice S; Levine, Douglas A; Shih, Ie-Ming; Shoupe, Donna; Swisher, Elizabeth M; Walker, Joan; Trabert, Britton; Greene, Mark H; Samimi, Goli; Temkin, Sarah M; Minasian, Lori M

2016-09-01

Women with clinically detected high-grade serous carcinomas (HGSC) generally present with advanced-stage disease, which portends a poor prognosis, despite extensive surgery and intensive chemotherapy. Historically, HGSCs were presumed to arise from the ovarian surface epithelium (OSE), but the inability to identify early-stage HGSCs and their putative precursors in the ovary dimmed prospects for advancing our knowledge of the pathogenesis of these tumors and translating these findings into effective prevention strategies. Over the last decade, increased BRCA1/2 mutation testing coupled with performance of risk-reducing surgeries has enabled studies that have provided strong evidence that many, but probably not all, HGSCs among BRCA1/2 mutation carriers appear to arise from the fallopian tubes, rather than from the ovaries. This shift in our understanding of the pathogenesis of HGSCs provides an important opportunity to achieve practice changing advances; however, the scarcity of clinically annotated tissues containing early lesions, particularly among women at average risk, poses challenges to progress. Accordingly, we review studies that have kindled our evolving understanding of the pathogenesis of HGSC and present the rationale for developing an epidemiologically annotated national specimen resource to support this research. Cancer Prev Res; 9(9); 713-20. ©2016 AACR. ©2016 American Association for Cancer Research.

Advances in combination therapy of lung cancer: Rationales, delivery technologies and dosage regimens.

PubMed

Wu, Lan; Leng, Donglei; Cun, Dongmei; Foged, Camilla; Yang, Mingshi

2017-08-28

Lung cancer is a complex disease caused by a multitude of genetic and environmental factors. The progression of lung cancer involves dynamic changes in the genome and a complex network of interactions between cancer cells with multiple, distinct cell types that form tumors. Combination therapy using different pharmaceuticals has been proven highly effective due to the ability to affect multiple cellular pathways involved in the disease progression. However, the currently used drug combination designs are primarily based on empirical clinical studies, and little attention has been given to dosage regimens, i.e. how administration routes, onsets, and durations of the combinations influence the therapeutic outcome. This is partly because combination therapy is challenged by distinct physicochemical properties and in vivo pharmacokinetics/pharmacodynamics of the individual pharmaceuticals, including small molecule drugs and biopharmaceuticals, which make the optimization of dosing and administration schedule challenging. This article reviews the recent advances in the design and development of combinations of pharmaceuticals for the treatment of lung cancer. Focus is primarily on rationales for the selection of specific combination therapies for lung cancer treatment, and state of the art of delivery technologies and dosage regimens for the combinations, tested in preclinical and clinical trials. Copyright © 2017 Elsevier B.V. All rights reserved.

An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment.

PubMed

Jepson, Marcus; Elliott, Daisy; Conefrey, Carmel; Wade, Julia; Rooshenas, Leila; Wilson, Caroline; Beard, David; Blazeby, Jane M; Birtle, Alison; Halliday, Alison; Stein, Rob; Donovan, Jenny L

2018-07-01

To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. Qualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties. One in 10 appointments did not include any mention of randomization. Most included a description of the method or process of allocation. Descriptions often made reference to gambling-related metaphors or similes, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was "best for them". Descriptions of the rationale for randomization were rarely present and often only came about as a consequence of patients questioning the reason for a random allocation. The methods and processes of randomization were usually described by recruiters, but often without clarity, which could lead to patient misunderstanding. The rationale for randomization was rarely mentioned. Recruiters should avoid problematic gambling metaphors and illusions of agency in their explanations and instead focus on clearer descriptions of the rationale and method of randomization to ensure patients are better informed about randomization and RCT participation. Copyright © 2018 University of Bristol. Published by Elsevier Inc. All rights reserved.

Theoretical rationale for music selection in oncology intervention research: an integrative review.

PubMed

Burns, Debra S

2012-01-01

Music-based interventions have helped patients with cancer improve their quality of life, decrease treatment related distress, and manage pain. However, quantitative findings from music intervention studies are inconsistent. The purpose of this review was to explore the theoretical underpinnings for the selection of the music stimuli used to influence targeted outcomes. It was hypothesized that disparate findings were due in part to the atheoretical nature of music selection and the resulting diversity in music stimuli between and within studies. A systematic research synthesis including a comprehensive database and reference list search resulted in 22 studies. Included studies were compiled into two tables cataloging intervention theory, intervention content, and outcomes. A majority of studies did not provide a rationale or intervention theory for the delivery of music or choice of outcomes. Recorded music was the most common delivery method, but the specific music was rarely included within the report. Only two studies that included a theoretical framework reported null results on at least some of the outcomes. Null results are partially explained by an incomplete or mismatch in intervention theory and music selection and delivery. While the inclusion of an intervention theory does not guarantee positive results, including a theoretical rationale for the use of music, particular therapeutic processes or mechanisms, and the specifics of how music is selected and delivered increases scientific rigor and the probability of clinical translation.

An Evaluation of the Implementation of Maternal Obesity Pathways of Care: A Mixed Methods Study with Data Integration

PubMed Central

Heslehurst, Nicola; Dinsdale, Sarah; Sedgewick, Gillian; Simpson, Helen; Sen, Seema; Summerbell, Carolyn Dawn; Rankin, Judith

2015-01-01

Objectives Maternal obesity has multiple associated risks and requires substantial intervention. This research evaluated the implementation of maternal obesity care pathways from multiple stakeholder perspectives. Study Design A simultaneous mixed methods model with data integration was used. Three component studies were given equal priority. 1: Semi-structured qualitative interviews explored obese pregnant women’s experiences of being on the pathways. 2: A quantitative and qualitative postal survey explored healthcare professionals’ experiences of delivering the pathways. 3: A case note audit quantitatively assessed pathway compliance. Data were integrated using following a thread and convergence coding matrix methods to search for agreement and disagreement between studies. Results Study 1: Four themes were identified: women’s overall (positive and negative) views of the pathways; knowledge and understanding of the pathways; views on clinical and weight management advice and support; and views on the information leaflet. Key results included positive views of receiving additional clinical care, negative experiences of risk communication, and weight management support was considered a priority. Study 2: Healthcare professionals felt the pathways were worthwhile, facilitated good practice, and increased confidence. Training was consistently identified as being required. Healthcare professionals predominantly focussed on women’s response to sensitive obesity communication. Study 3: There was good compliance with antenatal clinical interventions. However, there was poor compliance with public health and postnatal interventions. There were some strong areas of agreement between component studies which can inform future development of the pathways. However, disagreement between studies included a lack of shared priorities between healthcare professionals and women, different perspectives on communication issues, and different perspectives on women’s prioritisation of weight management. Conclusion The differences between healthcare professionals’ and women’s priorities and perspectives are important factors to consider when developing care pathways. Shared perspectives could help facilitate more effective implementation of the pathway interventions that have poor compliance. PMID:26018338

A national stakeholder consensus study of challenges and priorities for clinical learning environments in postgraduate medical education.

PubMed

Kilty, Caroline; Wiese, Anel; Bergin, Colm; Flood, Patrick; Fu, Na; Horgan, Mary; Higgins, Agnes; Maher, Bridget; O'Kane, Grainne; Prihodova, Lucia; Slattery, Dubhfeasa; Stoyanov, Slavi; Bennett, Deirdre

2017-11-22

High quality clinical learning environments (CLE) are critical to postgraduate medical education (PGME). The understaffed and overcrowded environments in which many residents work present a significant challenge to learning. The purpose of this study was to develop a national expert group consensus amongst stakeholders in PGME to; (i) identify important barriers and facilitators of learning in CLEs and (ii) indicate priority areas for improvement. Our objective was to provide information to focus efforts to provide high quality CLEs. Group Concept Mapping (GCM) is an integrated mixed methods approach to generating expert group consensus. A multi-disciplinary group of experts were invited to participate in the GCM process via an online platform. Multi-dimensional scaling and hierarchical cluster analysis were used to analyse participant inputs in regard to barriers, facilitators and priorities. Participants identified facilitators and barriers in ten domains within clinical learning environments. Domains rated most important were those which related to residents' connection to and engagement with more senior doctors. Organisation and conditions of work and Time to learn with senior doctors during patient care were rated as the most difficult areas in which to make improvements. High quality PGME requires that residents engage and connect with senior doctors during patient care, and that they are valued and supported both as learners and service providers. Academic medicine and health service managers must work together to protect these elements of CLEs, which not only shape learning, but impact quality of care and patient safety.

Identification of translational dermatology research priorities in the U.K.: results of an electronic Delphi exercise.

PubMed

Healy, E; Brown, S J; Langan, S M; Nicholls, S G; Shams, K; Reynolds, N J

2015-11-01

Translational research is the direct application of basic and applied research to patient care. It is estimated that there are at least 2000 different skin diseases; thus, there are considerable challenges in seeking to undertake research on each of these disorders. This electronic Delphi (e-Delphi) exercise was conducted in order to generate a list of translational dermatology research questions that are regarded as a priority for further investigations. During the first phase of the e-Delphi exercise, 228 research questions were generated by an expert panel that included clinical academic dermatologists, clinical dermatologists, nonclinical scientists, dermatology trainees and representatives from patient support groups. Following completion of the second and third phases, 40 questions on inflammatory skin disease, 20 questions on structural skin disorders/genodermatoses, 37 questions on skin cancer and eight miscellaneous questions were designated as priority translational dermatology research questions (PRQs). In addition to PRQs on a variety of disease areas (including multiple PRQs on psoriasis, eczema, squamous cell carcinoma and melanoma), there were a number of cross-cutting themes that identified a need to investigate mechanisms/pathogenesis of disease and the necessity to improve treatments for patients with skin disease. It is predicted that this list of PRQs will help to provide a strategic direction for translational dermatology research in the U.K. and that addressing this list of questions will ultimately provide clinical benefit for substantial numbers of patients with skin disorders. © 2015 British Association of Dermatologists.

Locating Errors Through Networked Surveillance: A Multimethod Approach to Peer Assessment, Hazard Identification, and Prioritization of Patient Safety Efforts in Cardiac Surgery.

PubMed

Thompson, David A; Marsteller, Jill A; Pronovost, Peter J; Gurses, Ayse; Lubomski, Lisa H; Goeschel, Christine A; Gosbee, John W; Wahr, Joyce; Martinez, Elizabeth A

2015-09-01

The objectives were to develop a scientifically sound and feasible peer-to-peer assessment model that allows health-care organizations to evaluate patient safety in cardiovascular operating rooms and to establish safety priorities for improvement. The locating errors through networked surveillance study was conducted to identify hazards in cardiac surgical care. A multidisciplinary team, composed of organizational sociology, organizational psychology, applied social psychology, clinical medicine, human factors engineering, and health services researchers, conducted the study. We used a transdisciplinary approach, which integrated the theories, concepts, and methods from each discipline, to develop comprehensive research methods. Multiple data collection was involved: focused literature review of cardiac surgery-related adverse events, retrospective analysis of cardiovascular events from a national database in the United Kingdom, and prospective peer assessment at 5 sites, involving survey assessments, structured interviews, direct observations, and contextual inquiries. A nominal group methodology, where one single group acts to problem solve and make decisions was used to review the data and develop a list of the top priority hazards. The top 6 priority hazard themes were as follows: safety culture, teamwork and communication, infection prevention, transitions of care, failure to adhere to practices or policies, and operating room layout and equipment. We integrated the theories and methods of a diverse group of researchers to identify a broad range of hazards and good clinical practices within the cardiovascular surgical operating room. Our findings were the basis for a plan to prioritize improvements in cardiac surgical care. These study methods allowed for the comprehensive assessment of a high-risk clinical setting that may translate to other clinical settings.

[The Jena Anxiety Monitoring List (JAMoL) - a tool for the evidence-based treatment of panic disorder with or without agoraphobia in primary care].

PubMed

Hiller, Thomas Stephan; Freytag, Antje; Breitbart, Jörg; Teismann, Tobias; Schöne, Elisabeth; Blank, Wolfgang; Schelle, Mercedes; Vollmar, Horst Christian; Margraf, Jürgen; Gensichen, Jochen

2018-04-01

Behavior therapy-oriented methods are recommended for treating anxiety disorders in primary care. The treatment of patients with long-term conditions can be improved by case management and structured clinical monitoring. The present paper describes the rationale, design and application of the 'Jena Anxiety Monitoring List' (JAMoL), a monitoring tool for the treatment of patients with panic disorder, with or without agoraphobia, in primary care. JAMoL's design was based on established clinical measures, the rationale of exposure-based anxiety treatment, and research on family practice-based case management. After piloting, the JAMoL was used in the clinical study 'Jena-PARADISE' (ISRCTN64669297), where non-physician practice staff monitored patients with panic disorder by telephone. Using semi-structured interviews in concomitant studies, study participants were asked about the instrument's functionality. The JAMoL assesses the severity of anxiety symptoms (6 items) as well as the patient's adherence to therapy (4 items) and fosters the case management-related information exchange (3 items). An integrated traffic light scheme facilitates the evaluation of monitoring results. Within the clinical study, non-physician practice staff carried out a total of 1,525 JAMoL-supported monitoring calls on 177 patients from 30 primary care practices (median calls per patient: 10 [interquartile range, 9-10]). Qualitative analyses revealed that most practice teams and patients rated the JAMoL as a practicable and treatment-relevant tool. The JAMoL enables primary care practice teams to continuously monitor anxiety symptoms and treatment adherence in patients with panic disorder with or without agoraphobia. Within the behavior therapy-oriented treatment program 'Jena-PARADISE', the JAMoL constitutes an important case management tool. Copyright © 2018. Published by Elsevier GmbH.

Targeting the cyclin D-cyclin-dependent kinase (CDK) 4/6-retinoblastoma pathway with selective CDK 4/6 inhibitors in hormone receptor-positive breast cancer: rationale, current status, and future directions.

PubMed

Spring, Laura; Bardia, Aditya; Modi, Shanu

2016-01-01

Dysregulation of the cyclin D-cyclin-dependent kinase (CDK) 4/6-INK4-retinoblastoma (Rb) pathway is an important contributor to endocrine therapy resistance. Recent clinical development of selective inhibitors of CDK4 and CDK6 kinases has led to renewed interest in cell cycle regulators, following experience with relatively non-selective pan-CDK inhibitors that often resulted in limited activity and poor safety profiles in the clinic. The highly selective oral CDK 4/6 inhibitors palbociclib (PD0332991), ribociclib (LEE011), and abemaciclib (LY2835219) are able to inhibit the proliferation of Rb-positive tumor cells and have demonstrated dose-dependent growth inhibition in ER+ breast cancer models. In metastatic breast cancer, all three agents are being explored in combination with endocrine therapy in Phase III studies. Results so far indicated promising efficacy and manageable safety profiles, and led to the FDA approval of palbociclib. Phase II-III studies of these agents, in combination with endocrine therapy, are also underway in early breast cancer in the neoadjuvant and adjuvant settings. Selective CDK 4/6 inhibitors are also being investigated with other targeted agents or chemotherapy in the advanced setting. This article reviews the rationale for targeting cyclin D-CDK 4/6 in hormone receptor-positive (HR+) breast cancer, provides an overview of the available preclinical and clinical data with CDK 4/6 inhibitors in breast cancer to date, and summarizes the main features of ongoing clinical trials of these new agents in breast cancer. Future trials evaluating further combination strategies with CDK 4/6 backbone and translational studies refining predictive biomarkers are needed to help personalize the optimal treatment regimen for individual patients with ER+ breast cancer.

The top 10 research priorities in cystic fibrosis developed by a partnership between people with CF and healthcare providers.

PubMed

Rowbotham, Nicola J; Smith, Sherie; Leighton, Paul A; Rayner, Oli C; Gathercole, Katie; Elliott, Zoe C; Nash, Edward F; Daniels, Tracey; Duff, Alistair J A; Collins, Sarah; Chandran, Suja; Peaple, Ursula; Hurley, Matthew N; Brownlee, Keith; Smyth, Alan R

2018-04-01

There remain many treatment uncertainties in cystic fibrosis (CF). With limited resources, research should focus on questions which are most important to the CF community. We conducted a James Lind Alliance Priority Setting Partnership in CF. Research questions were elicited and then prioritised in successive surveys. A workshop agreed the final top 10. Online methods avoided cross infection and widened participation. The elicitation survey had 482 respondents (1080 questions) and prioritisation survey 677 respondents. Participants were drawn equally from the patient and clinical communities globally. We have achieved a consensus on 10 research priorities which will be attractive to funders. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Justify Your Answer: The Role of Written Think Aloud in Script Concordance Testing.

PubMed

Power, Alyssa; Lemay, Jean-Francois; Cooke, Suzette

2017-01-01

Construct: Clinical reasoning assessment is a growing area of interest in the medical education literature. Script concordance testing (SCT) evaluates clinical reasoning in conditions of uncertainty and has emerged as an innovative tool in the domain of clinical reasoning assessment. SCT quantifies the degree of concordance between a learner and an experienced clinician and attempts to capture the breadth of responses of expert clinicians, acknowledging the significant yet acceptable variation in practice under situations of uncertainty. SCT has been shown to be a valid and reliable clinical reasoning assessment tool. However, as SCT provides only quantitative information, it may not provide a complete assessment of clinical reasoning. Think aloud (TA) is a qualitative research tool used in clinical reasoning assessment in which learners verbalize their thought process around an assigned task. This study explores the use of TA, in the form of written reflection, in SCT to assess resident clinical reasoning, hypothesizing that the information obtained from the written TA would enrich the quantitative data obtained through SCT. Ninety-one pediatric postgraduate trainees and 21 pediatricians from 4 Canadian training centers completed an online test consisting of 24 SCT cases immediately followed by retrospective written TA. Six of 24 cases were selected to gather TA data. These cases were chosen to allow all phases of clinical decision making (diagnosis, investigation, and treatment) to be represented in the TA data. Inductive thematic analysis was employed when systematically reviewing TA responses. Three main benefits of adding written TA to SCT were identified: (a) uncovering instances of incorrect clinical reasoning despite a correct SCT response, (b) revealing sound clinical reasoning in the context of a suboptimal SCT response, and (c) detecting question misinterpretation. Written TA can optimize SCT by demonstrating when correct examinee responses are based on guessing or uncertainty rather than robust clinical rationale. TA can also enhance SCT by allowing examinees to provide justification for responses that otherwise would have been considered incorrect and by identifying questions that are frequently misinterpreted to avoid including them in future examinations. TA also has significant value in differentiating between acceptable variations in expert clinician responses and deviance associated with faulty rationale or question misinterpretation; this could improve SCT reliability. A written TA protocol appears to be a valuable tool to assess trainees' clinical reasoning and can strengthen the quantitative assessment provided by SCT.

Social values and health priority setting in Australia: an analysis applied to the context of health technology assessment.

PubMed

Whitty, Jennifer A; Littlejohns, Peter

2015-02-01

To describe the role of social values in priority setting related to health technology assessment processes and decision-making in Australia. The processes and decision criteria of the Pharmaceutical and Medical Benefits Advisory Committees are described based on literature and policy sources, and analysed using a framework for identifying social values in priority-setting. Transparency and accountability of processes are apparent. Participation balances inclusiveness and effectiveness of decision-making, but presents an opportunity to enhance priority setting processes. Clinical and cost-effectiveness are important content considerations. Social values related to justice/equity are considered, without quantification of criteria weights for equity relative to other factors. HTA processes support solidarity through subsidising approved technologies for all Australians, whilst retaining autonomy by permitting non-subsidised technologies to be accessed privately, leading to possible tension between the values of solidarity, autonomy and equity. Priority setting related to health technology subsidy incorporates a range of inter-related social values in the processes and content of decision-making. Participation in decision-making could arguably be improved if a patient and public engagement policy were to be formulated alongside more widespread changes across processes to assess social values using approaches such as the Citizens' Jury. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Improvement Research Priorities: USA Survey and Expert Consensus

PubMed Central

Stevens, Kathleen R.; Ovretveit, John

2013-01-01

The purpose of this study was to identify stakeholder views about national priorities for improvement science and build agreement for action in a national improvement and implementation research network in the USA. This was accomplished using three stages of identification and consensus. (1) Topics were identified through a multipronged environmental scan of the literature and initiatives. (2) Based on this scan, a survey was developed, and stakeholders (n = 2,777) were invited to rate the resulting 33-topic, 9-category list, via an online survey. Data from 560 respondents (20% response) were analyzed. (3) An expert panel used survey results to further refine the research priorities through a Rand Delphi process. Priorities identified were within four categories: care coordination and transitions, high-performing clinical systems and microsystems improvement approaches, implementation of evidence-based improvements and best practices, and culture of quality and safety. The priorities identified were adopted by the improvement science research network as the research agenda to guide strategy. The process and conclusions may be of value to quality improvement research funding agencies, governments, and research units seeking to concentrate their resources on improvement topics where research is capable of yielding timely and actionable answers as well as contributing to the knowledge base for improvement. PMID:24024029

A historical perspective on ventilator management.

PubMed

Shapiro, B A

1994-02-01

Paralysis via neuromuscular blockade in ICU patients requires mechanical ventilation. This review historically addresses the technological advances and scientific information upon which ventilatory management concepts are based, with special emphasis on the influence such concepts have had on the use of neuromuscular blocking agents. Specific reference is made to the scientific information and technological advances leading to the newer concepts of ventilatory management. Information from > 100 major studies in the peer-reviewed medical literature, along with the author's 25 yrs of clinical experience and academic involvement in acute respiratory care is presented. Nomenclature related to ventilatory management is specifically defined and consistently utilized to present and interpret the data. Pre-1970 ventilatory management is traced from the clinically unacceptable pressure-limited devices to the reliable performance of volume-limited ventilators. The scientific data and rationale that led to the concept of relatively large tidal volume delivery are reviewed in the light of today's concerns regarding alveolar overdistention, control-mode dyssynchrony, and auto-positive end-expiratory pressure. Also presented are the post-1970 scientific rationales for continuous positive airway pressure/positive end-expiratory pressure therapy, avoidance of alveolar hyperxia, and partial ventilatory support techniques (intermittent mandatory ventilation/synchronized intermittent mandatory ventilation). The development of pressure-support devices is discussed and the capability of pressure-control techniques is presented. The rationale for more recent concepts of total ventilatory support to avoid ventilator-induced lung injury is presented. The traditional techniques utilizing volume-preset ventilators with relatively large tidal volumes remain valid and desirable for the vast majority of patients requiring mechanical ventilation. Neuromuscular blockade is best avoided in these patients. However, adequate analgesia, amnesia, and sedation are required. For patients with severe lung disease, alveolar overdistention and hyperoxia should be avoided and may be best accomplished by total ventilatory support techniques, such as pressure control. Total ventilatory support requires neuromuscular blockade and may not provide eucapnic ventilation.

Short-term predictive capacity of two different triage systems in patients with acute heart failure: TRICA-EAHFE study.

PubMed

Miró, Òscar; Tost, Josep; Herrero, Pablo; Jacob, Javier; Martín-Sánchez, Francisco Javier; Gil, Víctor; Fernández-Pérez, Cristina; Escoda, Rosa; Llorens, Pere

2016-12-01

To evaluate whether prioritization of patients with acute heart failure (AHF) in the Andorran Triage Model/Spanish Triage System (MAT/SET) and the Manchester Triage System (MTS) also allows the identification of different profiles of outcome and prognosis and determine whether either system has a better predictive capacity of outcomes. Patients with AHF included in the Spanish EAHFE registry from hospitals using the MAT/SET or MTS were selected and divided according to the triage system used. Outcome variables included hospital admission, length of stay, death during admission, 3, 7, and 30-day all-cause mortality, and emergency department (ED) reconsultation at 30 days. The results were compared according to the level of priority and the triage system used. We included 3837 patients (MAT/SET=2474; MTS=1363) classified as follows: 4.0% level 1; 34.7% level 2; 55.1% level 3; and 6.3% levels 4-5. Both systems associated greater priority with higher rates of admission and mortality; the MTS associated greater priority with greater ED reconsultation and the MAT/SET found greater priority to be associated with less ED reconsultation. The discriminative capacity of the two scales for adverse outcomes was statistically significant, albeit poor, for almost all the outcome events and it was of scarce clinical relevance (Area under the curve of the receiver operating characteristic between 0.458 and 0.661). The prediction of the outcome of patients with AHF determined with the MAT/SET or MTS showed scarce differences between the two systems, and their discriminative capacity does not seem to be clinically relevant.

Pharmacotherapy of traumatic brain injury: state of the science and the road forward: report of the Department of Defense Neurotrauma Pharmacology Workgroup.

PubMed

Diaz-Arrastia, Ramon; Kochanek, Patrick M; Bergold, Peter; Kenney, Kimbra; Marx, Christine E; Grimes, Col Jamie B; Loh, L T C Yince; Adam, L T C Gina E; Oskvig, Devon; Curley, Kenneth C; Salzer, Wanda

2014-01-15

Despite substantial investments by government, philanthropic, and commercial sources over the past several decades, traumatic brain injury (TBI) remains an unmet medical need and a major source of disability and mortality in both developed and developing societies. The U.S. Department of Defense neurotrauma research portfolio contains more than 500 research projects funded at more than $700 million and is aimed at developing interventions that mitigate the effects of trauma to the nervous system and lead to improved quality of life outcomes. A key area of this portfolio focuses on the need for effective pharmacological approaches for treating patients with TBI and its associated symptoms. The Neurotrauma Pharmacology Workgroup was established by the U.S. Army Medical Research and Materiel Command (USAMRMC) with the overarching goal of providing a strategic research plan for developing pharmacological treatments that improve clinical outcomes after TBI. To inform this plan, the Workgroup (a) assessed the current state of the science and ongoing research and (b) identified research gaps to inform future development of research priorities for the neurotrauma research portfolio. The Workgroup identified the six most critical research priority areas in the field of pharmacological treatment for persons with TBI. The priority areas represent parallel efforts needed to advance clinical care; each requires independent effort and sufficient investment. These priority areas will help the USAMRMC and other funding agencies strategically guide their research portfolios to ensure the development of effective pharmacological approaches for treating patients with TBI.

Pharmacotherapy of Traumatic Brain Injury: State of the Science and the Road Forward: Report of the Department of Defense Neurotrauma Pharmacology Workgroup

PubMed Central

Kochanek, Patrick M.; Bergold, Peter; Kenney, Kimbra; Marx, Christine E.; Grimes, Col. Jamie B.; Loh, LTC Yince; Adam, LTC Gina E.; Oskvig, Devon; Curley, Kenneth C.; Salzer, Col. Wanda

2014-01-01

Abstract Despite substantial investments by government, philanthropic, and commercial sources over the past several decades, traumatic brain injury (TBI) remains an unmet medical need and a major source of disability and mortality in both developed and developing societies. The U.S. Department of Defense neurotrauma research portfolio contains more than 500 research projects funded at more than $700 million and is aimed at developing interventions that mitigate the effects of trauma to the nervous system and lead to improved quality of life outcomes. A key area of this portfolio focuses on the need for effective pharmacological approaches for treating patients with TBI and its associated symptoms. The Neurotrauma Pharmacology Workgroup was established by the U.S. Army Medical Research and Materiel Command (USAMRMC) with the overarching goal of providing a strategic research plan for developing pharmacological treatments that improve clinical outcomes after TBI. To inform this plan, the Workgroup (a) assessed the current state of the science and ongoing research and (b) identified research gaps to inform future development of research priorities for the neurotrauma research portfolio. The Workgroup identified the six most critical research priority areas in the field of pharmacological treatment for persons with TBI. The priority areas represent parallel efforts needed to advance clinical care; each requires independent effort and sufficient investment. These priority areas will help the USAMRMC and other funding agencies strategically guide their research portfolios to ensure the development of effective pharmacological approaches for treating patients with TBI. PMID:23968241

Accelerating Research Impact in a Learning Health Care System

PubMed Central

Elwy, A. Rani; Sales, Anne E.; Atkins, David

2017-01-01

Background: Since 1998, the Veterans Health Administration (VHA) Quality Enhancement Research Initiative (QUERI) has supported more rapid implementation of research into clinical practice. Objectives: With the passage of the Veterans Access, Choice and Accountability Act of 2014 (Choice Act), QUERI further evolved to support VHA’s transformation into a Learning Health Care System by aligning science with clinical priority goals based on a strategic planning process and alignment of funding priorities with updated VHA priority goals in response to the Choice Act. Design: QUERI updated its strategic goals in response to independent assessments mandated by the Choice Act that recommended VHA reduce variation in care by providing a clear path to implement best practices. Specifically, QUERI updated its application process to ensure its centers (Programs) focus on cross-cutting VHA priorities and specify roadmaps for implementation of research-informed practices across different settings. QUERI also increased funding for scientific evaluations of the Choice Act and other policies in response to Commission on Care recommendations. Results: QUERI’s national network of Programs deploys effective practices using implementation strategies across different settings. QUERI Choice Act evaluations informed the law’s further implementation, setting the stage for additional rigorous national evaluations of other VHA programs and policies including community provider networks. Conclusions: Grounded in implementation science and evidence-based policy, QUERI serves as an example of how to operationalize core components of a Learning Health Care System, notably through rigorous evaluation and scientific testing of implementation strategies to ultimately reduce variation in quality and improve overall population health. PMID:27997456

[Comparison of different moxibustion techniques in clinical treatment of diseases based on data mining].

PubMed

Zhu, Xue-liang; Tan, Zhan-na; Li, Bo-ying; Wang, Jian-ling; Shi, Jing; Sun, Yan-hui; Li, Xiao- feng; Xu, Jing; Zhang, Xuan-ping; Zhang, Xin; Du, Yu-zhu; Jia, Chun-shieng

2014-09-01

To explore the specific efficacy of different moxibustion techniques in treatment of common diseases and clinical indications, and compare the specificity in clinical indications and efficacy among different moxibustion techniques so as to guide clinical practice better. The modern computerization and data mining technology were adopted to set up moxibustion literature database. The relevant literature of moxibustion techniques in recent 60 years were collected, screened, examined, extracted and analyzed statistically so as to explore the advantages of different moxibustion techniques in clinical treatment. (1) Of 2,516 literature, moxa stick, moxe cone and moxa device were used in the highest frequency in internal medicine department, for 730 times, 278 times and 102 times respectively. The warm needling technique was used in the highest frequency, for 70 times in the surgical department. (2) In the dermatology department, the curative rate with moxa cone was the highest, 75%. In the ear-nose-throat department, the warm needing technique and moxa device achieved the highest curative rate, 49% for both of them. In the internal medicine department and surgical department, the curative rate of warm needling technique was 53% and 58% respectively. In the gynecology department, the curative rate of moxa device was the highest, 59%. In the pediatrics department, the curative rate of moxa cone was the highest, 80%. (3) The numbers of priority disorders, frequency ≥20 times: 24 kinds of disease for moxa stick, five kinds of disease for moxa cone, 2 kinds of disease for warm needling technqiue and one disorder for moxa device. Facial paralysis, diarrhea, lumbar and leg pain and elbow and knee swelling pain were of the highest priority, treated with these 4 moxibustion techniques, with a certain of literature research values. (4) The warm needling technique achieved the better efficacy on elbow and knee swelling pain, lumbar and leg pain and diarrhea compared with the other three techniques and the curative rate was higher. The moxa device tecnique achieved the higher curative rate for facial paralysis compared with the other three techniques. Through the comparison of application frequency, curative rate, clinical application frequency in disorders and the efficacy of priority disorders in the treatment with different moxibustion techniques, it is found that moxa stick, moxa cone and moxa device are simple in manipulation, safe and effective. Hence, they can be extensively used in the treatment of common disorders in every department in clinic. The warm needling technique acts on the body by the co-work of needling and warming stimulation of mugwort. It achieves the particular effect on the disorders with complicated etiologies compared with the other three techniques. It can be chosen in priority for the disorders caused by blockage in meridian and collateral and stagnation of qi and blood.

An anthology: Rationale for a US ballistic missile defense (1969 - 1984)

NASA Astrophysics Data System (ADS)

Tircuit, E. C.

1985-04-01

This anthology is a selection and short synopsis of representative articles on the rationale for a US ballistic missile defense (BMD). Unclassified articles and documents were reviewed and analyzed to identify and include nine representative articles in the anthology. The anthology reduces the search for quality material on the subject and documents the fundamental rationale for a BMD. The author concluded that the fundamental rationale for a US BMD is to deter nuclear war. In addition, specific rationale for a US BMD is provided in the anthology. Finally, an extensive bibliography is included in the anthology to enhance further research on the subject.

A CTSA Agenda to Advance Methods for Comparative Effectiveness Research

PubMed Central

Helfand, Mark; Tunis, Sean; Whitlock, Evelyn P.; Pauker, Stephen G.; Basu, Anirban; Chilingerian, Jon; Harrell Jr., Frank E.; Meltzer, David O.; Montori, Victor M.; Shepard, Donald S.; Kent, David M.

2011-01-01

Abstract Clinical research needs to be more useful to patients, clinicians, and other decision makers. To meet this need, more research should focus on patient‐centered outcomes, compare viable alternatives, and be responsive to individual patients’ preferences, needs, pathobiology, settings, and values. These features, which make comparative effectiveness research (CER) fundamentally patient‐centered, challenge researchers to adopt or develop methods that improve the timeliness, relevance, and practical application of clinical studies. In this paper, we describe 10 priority areas that address 3 critical needs for research on patient‐centered outcomes (PCOR): (1) developing and testing trustworthy methods to identify and prioritize important questions for research; (2) improving the design, conduct, and analysis of clinical research studies; and (3) linking the process and outcomes of actual practice to priorities for research on patient‐centered outcomes. We argue that the National Institutes of Health, through its clinical and translational research program, should accelerate the development and refinement of methods for CER by linking a program of methods research to the broader portfolio of large, prospective clinical and health system studies it supports. Insights generated by this work should be of enormous value to PCORI and to the broad range of organizations that will be funding and implementing CER. Clin Trans Sci 2011; Volume 4: 188–198 PMID:21707950

Integrating research into clinical internship training bridging the science/practice gap in pediatric psychology.

PubMed

McQuaid, Elizabeth L; Spirito, Anthony

2012-03-01

Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a "capstone experience"; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the "business of science." Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists.

Treatment-Resistant Major Depression: Rationale for NMDA Receptors as Targets and Nitrous Oxide as Therapy

PubMed Central

Zorumski, Charles F.; Nagele, Peter; Mennerick, Steven; Conway, Charles R.

2015-01-01

Major depressive disorder (MDD) remains a huge personal and societal encumbrance. Particularly burdensome is a virulent subtype of MDD, treatment resistant major depression (TMRD), which afflicts 15–30% of MDD patients. There has been recent interest in N-methyl-d-aspartate receptors (NMDARs) as targets for treatment of MDD and perhaps TMRD. To date, most pre-clinical and clinical studies have focused on ketamine, although psychotomimetic and other side effects may limit ketamine’s utility. These considerations prompted a recent promising pilot clinical trial of nitrous oxide, an NMDAR antagonist that acts through a mechanism distinct from that of ketamine, in patients with severe TRMD. In this paper, we review the clinical picture of TRMD as a subtype of MDD, the evolution of ketamine as a fast-acting antidepressant, and clinical and basic science studies supporting the possible use of nitrous oxide as a rapid antidepressant. PMID:26696909

Adjunctive 5-hydroxytryptophan slow-release for treatment-resistant depression: Clinical and pre-clinical rationale

PubMed Central

Jacobsen, Jacob P.R.; Krystal, Andrew D.; Krishnan, K. Ranga R.; Caron, Marc G.

2017-01-01

Serotonin transporter (SERT) inhibitors treat depression by elevating brain extracellular 5-hydroxytryptamine (5-HTExt). However, only one-third of patients respond adequately. Treatment-resistant depression (TRD) is a major unmet need. Interestingly, elevating 5-HTExt beyond what is achieved by a SERT inhibitor appears to treat TRD. Adjunctive administration of 5-hydroxytryptophan (5-HTP) safely elevates 5-HTExt beyond the SERT inhibitor effect in humans; but, 5-HTP cannot be a clinically viable drug because of its poor pharmacokinetics. A slow-release (SR) delivery mode would be predicted to overcome the pharmacokinetic limitations of 5-HTP, substantially enhance the pharmacological action, and transform 5-HTP into a clinically viable drug. Animal studies bear out this prediction. Thus, adjunct 5-HTP SR could be an important new treatment for TRD. Here we review the clinical and preclinical evidence. PMID:27692695

Predicting adverse hemodynamic events in critically ill patients.

PubMed

Yoon, Joo H; Pinsky, Michael R

2018-06-01

The art of predicting future hemodynamic instability in the critically ill has rapidly become a science with the advent of advanced analytical processed based on computer-driven machine learning techniques. How these methods have progressed beyond severity scoring systems to interface with decision-support is summarized. Data mining of large multidimensional clinical time-series databases using a variety of machine learning tools has led to our ability to identify alert artifact and filter it from bedside alarms, display real-time risk stratification at the bedside to aid in clinical decision-making and predict the subsequent development of cardiorespiratory insufficiency hours before these events occur. This fast evolving filed is primarily limited by linkage of high-quality granular to physiologic rationale across heterogeneous clinical care domains. Using advanced analytic tools to glean knowledge from clinical data streams is rapidly becoming a reality whose clinical impact potential is great.

Leveraging Epidemiology and Clinical Studies of Cancer Outcomes: Recommendations and Opportunities for Translational Research

PubMed Central

2013-01-01

As the number of cancer survivors continues to grow, research investigating the factors that affect cancer outcomes, such as disease recurrence, risk of second malignant neoplasms, and the late effects of cancer treatments, becomes ever more important. Numerous epidemiologic studies have investigated factors that affect cancer risk, but far fewer have addressed the extent to which demographic, lifestyle, genomic, clinical, and psychosocial factors influence cancer outcomes. To identify research priorities as well as resources and infrastructure needed to advance the field of cancer outcomes and survivorship research, the National Cancer Institute sponsored a workshop titled “Utilizing Data from Cancer Survivor Cohorts: Understanding the Current State of Knowledge and Developing Future Research Priorities” on November 3, 2011, in Washington, DC. This commentary highlights recent findings presented at the workshop, opportunities to leverage existing data, and recommendations for future research, data, and infrastructure needed to address high priority clinical and research questions. Multidisciplinary teams that include epidemiologists, clinicians, biostatisticians, and bioinformaticists will be essential to facilitate future cancer outcome studies focused on improving clinical care of cancer patients, identifying those at high risk of poor outcomes, and implementing effective interventions to ultimately improve the quality and duration of survival. PMID:23197494

Adhesives: Test Method, Group Assignment, and Categorization Guide for High-Loading Rate Applications - History and Rationale

DTIC Science & Technology

2017-04-20

Categorization Guide for High -Loading- Rate Applications – History and Rationale by Robert Jensen, David Flanagan, Daniel DeSchepper, and Charles...Adhesives: Test Method, Group Assignment, and Categorization Guide for High -Loading- Rate Applications – History and Rationale by Robert Jensen...Categorization Guide for High - Loading-Rate Applications – History and Rationale 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6

Implementation Strategies for Gender-Sensitive Public Health Practice: A European Workshop.

PubMed

Oertelt-Prigione, Sabine; Dalibert, Lucie; Verdonk, Petra; Stutz, Elisabeth Zemp; Klinge, Ineke

2017-11-01

Providing a robust scientific background for the focus on gender-sensitive public health and a systematic approach to its implementation. Within the FP7-EUGenMed project ( http://eugenmed.eu ) a workshop on sex and gender in public health was convened on February 2-3, 2015. The experts participated in moderated discussion rounds to (1) assemble available knowledge and (2) identify structural influences on practice implementation. The findings were summarized and analyzed in iterative rounds to define overarching strategies and principles. The participants discussed the rationale for implementing gender-sensitive public health and identified priorities and key stakeholders to engage in the process. Communication strategies and specific promotion strategies with distinct stakeholders were defined. A comprehensive list of gender-sensitive practices was established using the recently published taxonomy of the Expert Recommendations for Implementing Change (ERIC) project as a blueprint. A clearly defined implementation strategy should be mandated for all new projects in the field of gender-sensitive public health. Our tool can support researchers and practitioners with the analysis of current and past research as well as with the planning of new projects.

[Territory, intersectoriality and stages: requirements for the effectiveness of the sustainable development goals].

PubMed

Gallo, Edmundo; Setti, Andréia Faraoni Freitas

2014-11-01

The post-2015 development agenda highlights the incorporation of sustainability in approaches developed and/or applied to distinct fields of knowledge and action and the demonstration of the effectiveness of experiences of sustainable and healthy territories. This process results from the confrontation of different viewpoints which seek to address social production vis-à-vis their project, with the possibility of updating the hegemonic mode of production and consumption or the emergence of counter-hegemonic rationales. Health, as one of the SDGs, has the challenge of imposing an intersectorial agenda that addresses its social determinants, in a process of participative governance able to build a hierarchy of priorities based on the needs of the territory and build techno-political solutions based on the ecology of knowledge, constituting a strategic-situational and communicative management process. The consistency in formulation of the agenda and potential challenges to its implementation are analyzed, considering its intersectoriality, its strategic governance and management, and especially an assessment of its effectiveness. Moreover, it tests the evaluative tools used and their ability to analyze the consistency in the formulation of the agenda.

Event-Based Surveillance During EXPO Milan 2015: Rationale, Tools, Procedures, and Initial Results

PubMed Central

Manso, Martina Del; Caporali, Maria Grazia; Napoli, Christian; Linge, Jens P.; Mantica, Eleonora; Verile, Marco; Piatti, Alessandra; Pompa, Maria Grazia; Vellucci, Loredana; Costanzo, Virgilio; Bastiampillai, Anan Judina; Gabrielli, Eugenia; Gramegna, Maria; Declich, Silvia

2016-01-01

More than 21 million participants attended EXPO Milan from May to October 2015, making it one of the largest protracted mass gathering events in Europe. Given the expected national and international population movement and health security issues associated with this event, Italy fully implemented, for the first time, an event-based surveillance (EBS) system focusing on naturally occurring infectious diseases and the monitoring of biological agents with potential for intentional release. The system started its pilot phase in March 2015 and was fully operational between April and November 2015. In order to set the specific objectives of the EBS system, and its complementary role to indicator-based surveillance, we defined a list of priority diseases and conditions. This list was designed on the basis of the probability and possible public health impact of infectious disease transmission, existing statutory surveillance systems in place, and any surveillance enhancements during the mass gathering event. This article reports the methodology used to design the EBS system for EXPO Milan and the results of 8 months of surveillance. PMID:27314656

The geography of graduate medical education: imbalances signal need for new distribution policies.

PubMed

Mullan, Fitzhugh; Chen, Candice; Steinmetz, Erika

2013-11-01

Graduate medical education (GME) determines the overall number, specialization mix, and geographic distribution of the US physician workforce. Medicare GME payments-which represent the largest single public investment in health workforce development-are allocated based on an inflexible system whose rationale, effectiveness, and balance are increasingly being scrutinized. We analyzed Medicare cost reports from teaching hospitals and found large state-level differences in the number of Medicare-sponsored residents per 100,000 population (1.63 in Montana versus 77.13 in New York), total Medicare GME payments ($1.64 million in Wyoming versus $2 billion in New York), payments per person ($1.94 in Montana versus $103.63 in New York), and average payments per resident ($63,811 in Louisiana versus $155,135 in Connecticut). Ways to address these imbalances include revising Medicare's GME funding formulas and protecting those states that receive less Medicare GME support in case funding is decreased and making them a priority if it is increased. The GME system badly needs a coordinating body to deliberate and make policy about public investments in graduate medical education.

Therapeutic Evaluation of Mesenchymal Stem Cells in Chronic Gut Inflammation

DTIC Science & Technology

2017-11-01

acute ) models of chemically-induced colitis. Based upon our studies, we believe the the rationale for the use of MSCs to treat patients with...rodent models of IBD, virtually all of these studies have used clinically-questionable doses of MSCs in 10 erosive, self-limiting (i.e. acute ...been demonstrated that ILC3-derived IL-22 attenuates acute and chronic intestinal inflam- mation induced in lymphopenic mice (Rag−/− mice) by Citrobacter

Rebuilding the Tower of Babel: A Revised Nomenclature for the Study of Suicide and Suicidal Behaviors. Part 2: Suicide-Related Ideations, Communications, and Behaviors

ERIC Educational Resources Information Center

Silverman, Morton M.; Berman, Alan L.; Sanddal, Nels D.; O'Carroll, Patrick W.; Joiner, Thomas E., Jr.

2007-01-01

Although a number of investigators have adopted the O'Carroll et al. (1996) nomenclature and applied it in their studies, and others have acknowledged its role in highlighting the need for clarification of terms, the nomenclature has not been widely used in the research and clinical communities. The rationale behind the rebuilding of the O'Carroll…

Organ Donation in the 50+ Age Demographic: Survey Results on Decision Rationale and Information Preferences.

PubMed

Tartaglia, Alexander; Dodd-McCue, Diane; Myer, Kevin A; Mullins, Andrew

2016-09-01

The rate of organ donation by older potential donors is significantly declining even though recent studies show positive clinical outcomes with organs transplanted from older donors. This study examined the 50+ age demographic to identify the rationale for donation decisions, preferred media methods of donation information delivery, and responsiveness to an age-tailored donation message. Results from 579 surveys, 87% from the 50+ age demographic, found respondents prone to self-select themselves as medically ineligible based on current medication and health status, even though they might be medically suitable donors. Their incentive to pursue additional information on donation is limited except when motivated by personal accounts within their families and communities. In addition, even when computer literate, they continue to favor the printed or spoken word for donation information delivery. The results suggest an opportunity for those working with older adults to develop more personalized, localized donation education programs targeting this age demographic. © The Author(s) 2014.

Application of plantar pressure assessment in footwear and insert design.

PubMed

Mueller, M J

1999-12-01

This clinical perspective describes the application of plantar pressure assessment in footwear and insert design. First, the rationale and evidence for using pressure assessment to assist in the design of footwear for patients with diabetes is described. I discuss 2 important measures obtained from pressure assessment: peak pressure, because it represents the magnitude of potential mechanical stresses that can contribute to skin breakdown, and contact area, because this identifies the treatment areas. Using measures obtained from pressure assessment, guidelines are presented to maximize contact area of the insert to the foot and reduce highest peak pressures on the skin, with the goal of preventing skin breakdown. Second, a rationale and guidelines are presented for the application of plantar pressure assessment in the evaluation and design of footwear for people without impairments (i.e., the general public). Finally, future applications of pressure assessment to improve the design and fit of shoes are discussed. Benefits and limitations of using pressure assessment to assist in footwear design are addressed throughout.

Rationale for the Use of CAD/CAM Technology in Implant Prosthodontics

PubMed Central

Abduo, Jaafar; Lyons, Karl

2013-01-01

Despite the predictable longevity of implant prosthesis, there is an ongoing interest to continue to improve implant prosthodontic treatment and outcomes. One of the developments is the application of computer-aided design and computer-aided manufacturing (CAD/CAM) to produce implant abutments and frameworks from metal or ceramic materials. The aim of this narrative review is to critically evaluate the rationale of CAD/CAM utilization for implant prosthodontics. To date, CAD/CAM allows simplified production of precise and durable implant components. The precision of fit has been proven in several laboratory experiments and has been attributed to the design of implants. Milling also facilitates component fabrication from durable and aesthetic materials. With further development, it is expected that the CAD/CAM protocol will be further simplified. Although compelling clinical evidence supporting the superiority of CAD/CAM implant restorations is still lacking, it is envisioned that CAD/CAM may become the main stream for implant component fabrication. PMID:23690778

BiomarCaRE: rationale and design of the European BiomarCaRE project including 300,000 participants from 13 European countries.

PubMed

Zeller, Tanja; Hughes, Maria; Tuovinen, Tarja; Schillert, Arne; Conrads-Frank, Annette; Ruijter, Hester den; Schnabel, Renate B; Kee, Frank; Salomaa, Veikko; Siebert, Uwe; Thorand, Barbara; Ziegler, Andreas; Breek, Heico; Pasterkamp, Gerard; Kuulasmaa, Kari; Koenig, Wolfgang; Blankenberg, Stefan

2014-10-01

Biomarkers are considered as tools to enhance cardiovascular risk estimation. However, the value of biomarkers on risk estimation beyond European risk scores, their comparative impact among different European regions and their role towards personalised medicine remains uncertain. Biomarker for Cardiovascular Risk Assessment in Europe (BiomarCaRE) is an European collaborative research project with the primary objective to assess the value of established and emerging biomarkers for cardiovascular risk prediction. BiomarCaRE integrates clinical and epidemiological biomarker research and commercial enterprises throughout Europe to combine innovation in biomarker discovery for cardiovascular disease prediction with consecutive validation of biomarker effectiveness in large, well-defined primary and secondary prevention cohorts including over 300,000 participants from 13 European countries. Results from this study will contribute to improved cardiovascular risk prediction across different European populations. The present publication describes the rationale and design of the BiomarCaRE project.

Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association.

PubMed

Demaerschalk, Bart M; Kleindorfer, Dawn O; Adeoye, Opeolu M; Demchuk, Andrew M; Fugate, Jennifer E; Grotta, James C; Khalessi, Alexander A; Levy, Elad I; Palesch, Yuko Y; Prabhakaran, Shyam; Saposnik, Gustavo; Saver, Jeffrey L; Smith, Eric E

2016-02-01

To critically review and evaluate the science behind individual eligibility criteria (indication/inclusion and contraindications/exclusion criteria) for intravenous recombinant tissue-type plasminogen activator (alteplase) treatment in acute ischemic stroke. This will allow us to better inform stroke providers of quantitative and qualitative risks associated with alteplase administration under selected commonly and uncommonly encountered clinical circumstances and to identify future research priorities concerning these eligibility criteria, which could potentially expand the safe and judicious use of alteplase and improve outcomes after stroke. Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association Stroke Council's Scientific Statement Oversight Committee and the American Heart Association's Manuscript Oversight Committee. The writers used systematic literature reviews, references to published clinical and epidemiology studies, morbidity and mortality reports, clinical and public health guidelines, authoritative statements, personal files, and expert opinion to summarize existing evidence and to indicate gaps in current knowledge and, when appropriate, formulated recommendations using standard American Heart Association criteria. All members of the writing group had the opportunity to comment on and approved the final version of this document. The document underwent extensive American Heart Association internal peer review, Stroke Council Leadership review, and Scientific Statements Oversight Committee review before consideration and approval by the American Heart Association Science Advisory and Coordinating Committee. After a review of the current literature, it was clearly evident that the levels of evidence supporting individual exclusion criteria for intravenous alteplase vary widely. Several exclusionary criteria have already undergone extensive scientific study such as the clear benefit of alteplase treatment in elderly stroke patients, those with severe stroke, those with diabetes mellitus and hyperglycemia, and those with minor early ischemic changes evident on computed tomography. Some exclusions such as recent intracranial surgery are likely based on common sense and sound judgment and are unlikely to ever be subjected to a randomized, clinical trial to evaluate safety. Most other contraindications or warnings range somewhere in between. However, the differential impact of each exclusion criterion varies not only with the evidence base behind it but also with the frequency of the exclusion within the stroke population, the probability of coexistence of multiple exclusion factors in a single patient, and the variation in practice among treating clinicians. © 2015 American Heart Association, Inc.

Combinations of Drugs in the Treatment of Obesity

PubMed Central

Halpern, Bruno; Oliveira, Eduardo S. L.; Faria, André M.; Halpern, Alfredo; de Melo, Maria Edna; Cercato, Cintia; Mancini, Marcio C.

2010-01-01

Obesity is a chronic disease associated with excess morbidity and mortality. Clinical treatment, however, currently offers disappointing results, with very high rates of weight loss failure or weight regain cycles, and only two drugs (orlistat and sibutramine) approved for long-term use. Drugs combinations can be an option for its treatment but, although widely used in clinical practice, very few data are available in literature for its validation. Our review focuses on the rationale for their use, with advantages and disadvantages; on combinations often used, with or without studies; and on new perspectives of combinations being studied mainly by the pharmaceutical industry. PMID:27713360

Double incision iso-anatomical ACL reconstruction: the freedom to place the femoral tunnel within the anatomical attachment site without exception.

PubMed

Arnold, Markus P; Duthon, Victoria; Neyret, Philippe; Hirschmann, Michael T

2013-02-01

The present paper describes the rationale behind the surgical technique and the clinical results of the iso-anatomical, single bundle bone patellar-tendon bone anterior cruciate ligament (ACL) reconstruction. Using a second incision on the distal lateral femur an outside-in femoral tunnel is drilled. Guided by a special aiming device it is possible to place the femoral tunnel in the centre of the ACL footprint in every single case. Since every crucial step of the procedure is under visual control, the technique is safe and reliable, which is mirrored by good clinical results.

Treatment of rheumatoid arthritis: a global perspective on the use of antirheumatic drugs

PubMed Central

Envalds, Minja; Pincus, Theodore

2008-01-01

Modern therapy for rheumatoid arthritis (RA) is based on knowledge of the severity of the natural history of the disease. RA patients are approached with early and aggressive treatment strategies, methotrexate as an anchor drug, biological targeted therapies in those with inadequate response to methotrexate, and “tight control,” aiming for remission and low disease activity according to quantitative monitoring. This chapter presents a rationale for current treatment strategies for RA with antirheumatic drugs, a review of published reports concerning treatments in clinical cohorts outside of clinical trials, and current treatments at 61 sites in 21 countries in the QUEST-RA database. PMID:18437286

Select clinical recommendations for military medical practitioners conducting humanitarian and civic assistance activities.

PubMed

Hollon, Justin R; Hickey, Patrick W

2010-09-01

Training and planning for stability, security, transition, and reconstruction, to include humanitarian and civic assistance activities, has taken on new importance for today's military forces. Deployed medical forces providing medical care to local populations are presented with the challenge of limited resources, complex public health needs, and complex cultural and linguistic barriers to care. In this article, we review some of the clinical situations commonly encountered during these operations and provide an evidence-based rationale for proposed courses of action. This report is timely given expanding operations in Afghanistan and the stand-up of the U.S. African Command (AFRICOM).

Adoptive therapy with chimeric antigen receptor-modified T cells of defined subset composition.

PubMed

Riddell, Stanley R; Sommermeyer, Daniel; Berger, Carolina; Liu, Lingfeng Steven; Balakrishnan, Ashwini; Salter, Alex; Hudecek, Michael; Maloney, David G; Turtle, Cameron J

2014-01-01

The ability to engineer T cells to recognize tumor cells through genetic modification with a synthetic chimeric antigen receptor has ushered in a new era in cancer immunotherapy. The most advanced clinical applications are in targeting CD19 on B-cell malignancies. The clinical trials of CD19 chimeric antigen receptor therapy have thus far not attempted to select defined subsets before transduction or imposed uniformity of the CD4 and CD8 cell composition of the cell products. This review will discuss the rationale for and challenges to using adoptive therapy with genetically modified T cells of defined subset and phenotypic composition.

Assessment of cognitive safety in clinical drug development

PubMed Central

Roiser, Jonathan P.; Nathan, Pradeep J.; Mander, Adrian P.; Adusei, Gabriel; Zavitz, Kenton H.; Blackwell, Andrew D.

2016-01-01

Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design and statistical analysis, from Phase I through to postmarketing. The crucial issue of how cognition should be assessed is emphasized, especially the sensitivity of measurement. We also consider how best to interpret the magnitude of any identified effects, including comparison with benchmarks. We conclude by discussing strategies for the effective communication of cognitive risks. PMID:26610416

Seeing Students Squirm: Nursing Students' Experiences of Bullying Behaviors During Clinical Rotations.

PubMed

Smith, Carolyn R; Gillespie, Gordon Lee; Brown, Kathryn C; Grubb, Paula L

2016-09-01

Bullying remains a troubling problem in the nursing profession. Nursing students may encounter bullying behavior in clinical settings. However, they may not be adequately prepared to recognize and handle bullying behavior when it occurs. This study's purpose was to gain a greater understanding of nursing students' experiences of bullying behaviors in the clinical setting. Using a descriptive qualitative approach, eight focus groups were held with 56 undergraduate baccalaureate nursing students from four college campuses. Focus group data were coded and analyzed for themes. Four categories were identified: Bullying Behaviors, Rationale for Bullying, Response to Bullying, and Recommendations to Address Bullying. Each category and its corresponding themes are presented. Interventions for nurse educators to address the bullying of nursing students in clinical settings are presented. [J Nurs Educ. 2016;55(9):505-513.]. Copyright 2016, SLACK Incorporated.

Seeing Students Squirm: Nursing Students’ Experiences of Bullying Behaviors During Clinical Rotations

PubMed Central

Smith, Carolyn R.; Gillespie, Gordon Lee; Brown, Kathryn C.; Grubb, Paula L.

2016-01-01

Background Bullying remains a troubling problem in the nursing profession. Nursing students may encounter bullying behavior in clinical settings. However nursing students may not be adequately prepared to recognize and handle bullying behavior when it occurs. The purpose of this study was to gain greater understanding of nursing students’ experiences of bullying behaviors in the clinical setting. Method Using a descriptive qualitative approach, eight focus groups were held with 56 undergraduate baccalaureate nursing students from four college campuses. Focus group data were coded and analyzed for themes. Results Four categories of themes were identified: bullying behaviors, rationale for bullying, response to bullying, and recommendations to address bullying. Each category and its corresponding themes are presented. Conclusion Interventions for nurse educators to address bullying of nursing students in clinical settings are presented. PMID:27560118

The Pan-University Network for Global Health: framework for collaboration and review of global health needs.

PubMed

Winchester, M S; BeLue, R; Oni, T; Wittwer-Backofen, U; Deobagkar, D; Onya, H; Samuels, T A; Matthews, S A; Stone, C; Airhihenbuwa, C

2016-04-21

In the current United Nations efforts to plan for post 2015-Millennium Development Goals, global partnership to address non-communicable diseases (NCDs) has become a critical goal to effectively respond to the complex global challenges of which inequity in health remains a persistent challenge. Building capacity in terms of well-equipped local researchers and service providers is a key to bridging the inequity in global health. Launched by Penn State University in 2014, the Pan University Network for Global Health responds to this need by bridging researchers at more than 10 universities across the globe. In this paper we outline our framework for international and interdisciplinary collaboration, as well the rationale for our research areas, including a review of these two themes. After its initial meeting, the network has established two central thematic priorities: 1) urbanization and health and 2) the intersection of infectious diseases and NCDs. The urban population in the global south will nearly double in 25 years (approx. 2 billion today to over 3.5 billion by 2040). Urban population growth will have a direct impact on global health, and this growth will be burdened with uneven development and the persistence of urban spatial inequality, including health disparities. The NCD burden, which includes conditions such as hypertension, stroke, and diabetes, is outstripping infectious disease in countries in the global south that are considered to be disproportionately burdened by infectious diseases. Addressing these two priorities demands an interdisciplinary and multi-institutional model to stimulate innovation and synergy that will influence the overall framing of research questions as well as the integration and coordination of research.

Clinical findings provide criteria to evaluate priorities of ophthalmologic intervention in conscious multiple trauma patients.

PubMed

Shams-Vahdati, Samad; Gholipour, Changiz; Jalilzadeh-Binazar, Mehran; Moharamzadeh, Payman; Sorkhabi, Rana; Jalilian, Respina

2015-07-01

Multiple trauma patients frequently suffer eye injuries, especially those patients with head traumas. We evaluated the accuracy of physical findings to determine the priorities of emergency ophthalmologic intervention in these patients. This study included all multiple trauma patients with ophthalmic trauma who had a GCS of 15 when they arrived at the emergency department during the period of March, 2008-March, 2009. First, we evaluated the patients according to the criteria of the study. Then, an ophthalmologist evaluated them. From March 2008-March 2009, 306 multiple trauma patients with ocular trauma came to our ED. The sensitivity and accuracy of emergency physicians in diagnosing the priority of ophthalmologic treatment were comparable to an ophthalmologist (measure of agreement in kappa=0.967). The ability of an emergency physician or general surgeon to determine the actual need of early ophthalmologist intervention can improve decision making and saving both time and money. Our study suggests that it is possible to determine according to clinical findings the need of the patient to have ophthalmologic intervention without referring the patient to ophthalmologist examination. Defining specific criteria of ophthalmologic examinations can clarify the necessity of emergency ophthalmologic examination and intervention. Copyright © 2014 Elsevier Ltd. All rights reserved.

From reactive to proactive: developing a valid clinical ethics needs assessment survey to support ethics program strategic planning (part 1 of 2).

PubMed

Frolic, Andrea; Jennings, Barb; Seidlitz, Wendy; Andreychuk, Sandy; Djuric-Paulin, Angela; Flaherty, Barb; Peace, Donna

2013-03-01

As ethics committees and programs become integrated into the "usual business" of healthcare organizations, they are likely to face the predicament of responding to greater demands for service and higher expectations, without an influx of additional resources. This situation demands that ethics committees and programs allocate their scarce resources (including their time, skills and funds) strategically, rather than lurching from one ad hoc request to another; finding ways to maximize the effectiveness, efficiency, impact and quality of ethics services is essential in today's competitive environment. How can Hospital Ethics Committees (HECs) begin the process of strategic priority-setting to ensure they are delivering services where and how they are most needed? This paper describes the creation of the Clinical Ethics Needs Assessment Survey (CENAS) as a tool to understand interprofessional staff perceptions of the organization's ethical climate, challenging ethical issues and educational priorities. The CENAS was designed to support informed resource allocation and advocacy by HECs. By sharing our process of developing and validating this ethics needs assessment survey we hope to enable strategic priority-setting in other resource-strapped ethics programs, and to empower HECs to shift their focus to more proactive, quality-focused initiatives.

The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products

PubMed Central

Berman, Jonathan; Radhakrishna, Tanya

2017-01-01

The Neglected Tropical Disease Voucher Program is a Congressionally-mandated program intended to promote approval of products for tropical diseases because it provides spectacular financial compensation consequent to FDA approval of a priority product. Three drug approvals–artemether/lumifantrine for malaria, bedaquiline for multidrug resistant tuberculosis, miltefosine for leishmaniasis–have received Tropical Disease Vouchers to date. We give our view of the type of products that might qualify for a Tropical Disease Voucher, financial considerations in venturing capital to support product development, clinical ramifications of a successful product approval, and an overall evaluation of the Program. PMID:27573627

Benchmarking for the competitive marketplace.

PubMed

Clarke, R W; Sucher, T O

1999-07-01

One would get little argument these days regarding the importance of performance measurement in the health care industry. The traditional approach has been the straightforward use of measurable units such as financial comparisons and clinical indicators (e.g., length of stay). Also we in the health care industry have traditionally benchmarked our performance and strategies against those most like ourselves. Today's competitive market demands a more customer-focused set of performance measures that go beyond traditional approaches such as customer service. The most important task in today's environment is to study the customers' emerging priorities and adjust our business to meet those priorities.

The no-show rate in a high-risk obstetric clinic.

PubMed

Campbell, J D; Chez, R A; Queen, T; Barcelo, A; Patron, E

2000-10-01

We wished to determine the reasons for an average missed appointment rate of 28% in a high-risk pregnancy clinic. Only 41% of the 261 women in the study group could be reached by telephone. The reasons included not having a phone, the phone had been disconnected, incorrect phone number on the chart, the patient had moved, and the patient did not respond to the answering machine message. The reasons for missing the appointment included lack of transportation, scheduling problems, overslept or forgot, presence of a sick child or relative, and lack of child care. The response of patients to assessing prenatal care may reflect their priority of medical care relative to other priorities associated with day-to-day existence. There may be a baseline missed appointment rate for prenatal care in lower socioeconomic populations of women. The commitment of personnel time and energy to attempt to modify the no-show rate should be reexamined.

Neuroprosthetic technology for individuals with spinal cord injury

PubMed Central

Collinger, Jennifer L.; Foldes, Stephen; Bruns, Tim M.; Wodlinger, Brian; Gaunt, Robert; Weber, Douglas J.

2013-01-01

Context Spinal cord injury (SCI) results in a loss of function and sensation below the level of the lesion. Neuroprosthetic technology has been developed to help restore motor and autonomic functions as well as to provide sensory feedback. Findings This paper provides an overview of neuroprosthetic technology that aims to address the priorities for functional restoration as defined by individuals with SCI. We describe neuroprostheses that are in various stages of preclinical development, clinical testing, and commercialization including functional electrical stimulators, epidural and intraspinal microstimulation, bladder neuroprosthesis, and cortical stimulation for restoring sensation. We also discuss neural recording technologies that may provide command or feedback signals for neuroprosthetic devices. Conclusion/clinical relevance Neuroprostheses have begun to address the priorities of individuals with SCI, although there remains room for improvement. In addition to continued technological improvements, closing the loop between the technology and the user may help provide intuitive device control with high levels of performance. PMID:23820142

Clinical response of salaried consultants to economic incentives.

PubMed

Iversen, T

1998-01-01

Several studies have found a relation between economic incentives and physicians' clinical decisions. The bulk of these studies deals with data from private organisations providing medical care. The purpose of the present study is to explore whether a similar relationship is valid in a system where hospital care is provided by salaried physicians in the public sector. A distinction is made between medical and economic prioritysetting. If the relative fees influence the proportion of outpatient surgery or the compositions of treatments, economic prioritysetting is said to take place. Data were collected from a sample of Norwegian hospitals. The main findings of the empirical section can be summarised in two points: (i) Economic prioritysetting seems to be applied in the choice between inpatient and outpatient surgical treatment for patients with an identical diagnosis. (ii) Medical priority setting seems to be applied in the priority among patients with different diagnoses.

Treatment of early-onset schizophrenia spectrum disorders (TEOSS): rationale, design, and methods.

PubMed

McClellan, Jon; Sikich, Linmarie; Findling, Robert L; Frazier, Jean A; Vitiello, Benedetto; Hlastala, Stefanie A; Williams, Emily; Ambler, Denisse; Hunt-Harrison, Tyehimba; Maloney, Ann E; Ritz, Louise; Anderson, Robert; Hamer, Robert M; Lieberman, Jeffrey A

2007-08-01

The Treatment of Early Onset Schizophrenia Spectrum Disorders Study is a publicly funded clinical trial designed to compare the therapeutic benefits, safety, and tolerability of risperidone, olanzapine, and molindone in youths with early-onset schizophrenia spectrum disorders. The rationale, design, and methods of the Treatment of Early Onset Schizophrenia Spectrum Disorders Study are described. Using a randomized, double-blind, parallel-group design at four sites, youths with EOSS (ages 8-19 years) were assigned to an 8-week acute trial of risperidone (0.5-6.0 mg/day), olanzapine (2.5-20 mg/day), or molindone (10-140 mg/day). Responders continued double-blind treatment for 44 weeks. The primary outcome measure was responder status at 8 weeks, defined by a 20% reduction in baseline Positive and Negative Symptom Scale scores plus ratings of significant improvement on the Clinical Global Impressions. Secondary outcome measures included assessments of psychopathology, functional impairment, quality of life, and medication safety. An intent-to-treat analytic plan was used. From February 2002 to May 2006, 476 youths were screened, 173 were further evaluated, and 119 were randomized. Several significant study modifications were required to address safety, the use of adjunctive medications, and the termination of the olanzapine treatment arm due to weight gain. The Treatment of Early Onset Schizophrenia Spectrum Disorders Study will inform clinical practice regarding the use of antipsychotic medications for youths with early-onset schizophrenia spectrum disorders. Important safety concerns emerged during the study, including higher than anticipated rates of suicidality and problems tapering thymoleptic agents before randomization.

COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

PubMed Central

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-01-01

Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. PMID:21241828

Rationale and methodology of a collaborative learning project in congenital cardiac care

PubMed Central

Wolf, Michael J.; Lee, Eva K.; Nicolson, Susan C.; Pearson, Gail D.; Witte, Madolin K.; Huckaby, Jeryl; Gaies, Michael; Shekerdemian, Lara S.; Mahle, William T.

2018-01-01

Background Collaborative learning is a technique through which individuals or teams learn together by capitalizing on one another’s knowledge, skills, resources, experience, and ideas. Clinicians providing congenital cardiac care may benefit from collaborative learning given the complexity of the patient population and team approach to patient care. Rationale and development Industrial system engineers first performed broad-based time-motion and process analyses of congenital cardiac care programs at 5 Pediatric Heart Network core centers. Rotating multidisciplinary team site visits to each center were completed to facilitate deep learning and information exchange. Through monthly conference calls and an in-person meeting, we determined that duration of mechanical ventilation following infant cardiac surgery was one key variation that could impact a number of clinical outcomes. This was underscored by one participating center’s practice of early extubation in the majority of its patients. A consensus clinical practice guideline using collaborative learning was developed and implemented by multidisciplinary teams from the same 5 centers. The 1-year prospective initiative was completed in May 2015, and data analysis is under way. Conclusion Collaborative learning that uses multidisciplinary team site visits and information sharing allows for rapid structured fact-finding and dissemination of expertise among institutions. System modeling and machine learning approaches objectively identify and prioritize focused areas for guideline development. The collaborative learning framework can potentially be applied to other components of congenital cardiac care and provide a complement to randomized clinical trials as a method to rapidly inform and improve the care of children with congenital heart disease. PMID:26995379

COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

PubMed

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-05-01

Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

The design and rationale of an interdisciplinary, non-prescriptive, and Health at Every Size®-based clinical trial: The "Health and Wellness in Obesity" study.

PubMed

Ulian, Mariana D; Gualano, Bruno; Benatti, Fabiana B; de Campos-Ferraz, Patricia Lopes; Coelho, Desire; Roble, Odilon J; Sabatini, Fernanda; Perez, Isabel; Aburad, Luiz; Pinto, Ana Jéssica; Vessoni, André; Victor, Jhessica Campos; Lima, Victoria Kupper; Unsain, Ramiro Fernandez; de Morais Sato, Priscila; Rogero, Marcelo Macedo; Toporcov, Tatiana Natasha; Scagliusi, Fernanda B

2017-12-01

This manuscript describes the design and rationale of a clinical trial that aims to investigate the multiple physiological, attitudinal, nutritional, and behavioral effects of a new interdisciplinary intervention based on the Health at Every Size® (HAES®) approach in obese women. This will be a prospective, 7-month, randomized (2:1), mixed-method clinical trial. Obese women will be recruited and randomly allocated into two groups. The intervention group (I-HAES®; proposed n = 40) will undertake a novel HAES®-based intervention. Participants will take part in an exercise program, nutrition counseling sessions, and philosophical workshops, all aligned with the principles of the HAES® approach. The control group (CTRL; proposed n = 20) will participate in a program using a traditional HAES®-based group format, characterized by bimonthly lectures about the same topics offered to the experimental group, encouraging the adoption of a healthy lifestyle. The following multiple quantitative outcomes will be assessed pre and post intervention: health-related quality of life, cardiovascular risk factors, anthropometric assessments, physical activity level, physical capacity and function, and psychological and behavioral assessments. Qualitative analysis will be used to evaluate the experiences of the participants throughout the intervention, as assessed by focus groups and semi-structured interviews. The interdisciplinary research team leading this study has varied and complementary expertise. The knowledge arising from this study will help to guide new interdisciplinary interventions with the potential to holistically improve the health of obese individuals. This trial is registered at Clinicaltrials.gov (NCT02102061).

Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

PubMed

Cho, Alex H; Killeya-Jones, Ley A; O'Daniel, Julianne M; Kawamoto, Kensaku; Gallagher, Patrick; Haga, Susanne; Lucas, Joseph E; Trujillo, Gloria M; Joy, Scott V; Ginsburg, Geoffrey S

2012-01-18

Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve patients' clinical outcomes, risk perceptions, and/or their engagement in healthy behavior change. In addition, study design features such as the use of existing clinic personnel for risk counseling could inform the future development and implementation of care models for the use of individual genetic risk information in primary care. ClinicalTrials.gov: NCT00849563.

Accountable priority setting for trust in health systems--the need for research into a new approach for strengthening sustainable health action in developing countries.

PubMed

Byskov, Jens; Bloch, Paul; Blystad, Astrid; Hurtig, Anna-Karin; Fylkesnes, Knut; Kamuzora, Peter; Kombe, Yeri; Kvåle, Gunnar; Marchal, Bruno; Martin, Douglas K; Michelo, Charles; Ndawi, Benedict; Ngulube, Thabale J; Nyamongo, Isaac; Olsen, Oystein E; Onyango-Ouma, Washington; Sandøy, Ingvild F; Shayo, Elizabeth H; Silwamba, Gavin; Songstad, Nils Gunnar; Tuba, Mary

2009-10-24

Despite multiple efforts to strengthen health systems in low and middle income countries, intended sustainable improvements in health outcomes have not been shown. To date most priority setting initiatives in health systems have mainly focused on technical approaches involving information derived from burden of disease statistics, cost effectiveness analysis, and published clinical trials. However, priority setting involves value-laden choices and these technical approaches do not equip decision-makers to address a broader range of relevant values - such as trust, equity, accountability and fairness - that are of concern to other partners and, not least, the populations concerned. A new focus for priority setting is needed.Accountability for Reasonableness (AFR) is an explicit ethical framework for legitimate and fair priority setting that provides guidance for decision-makers who must identify and consider the full range of relevant values. AFR consists of four conditions: i) relevance to the local setting, decided by agreed criteria; ii) publicizing priority-setting decisions and the reasons behind them; iii) the establishment of revisions/appeal mechanisms for challenging and revising decisions; iv) the provision of leadership to ensure that the first three conditions are met.REACT - "REsponse to ACcountable priority setting for Trust in health systems" is an EU-funded five-year intervention study started in 2006, which is testing the application and effects of the AFR approach in one district each in Kenya, Tanzania and Zambia. The objectives of REACT are to describe and evaluate district-level priority setting, to develop and implement improvement strategies guided by AFR and to measure their effect on quality, equity and trust indicators. Effects are monitored within selected disease and programme interventions and services and within human resources and health systems management. Qualitative and quantitative methods are being applied in an action research framework to examine the potential of AFR to support sustainable improvements to health systems performance.This paper reports on the project design and progress and argues that there is a high need for research into legitimate and fair priority setting to improve the knowledge base for achieving sustainable improvements in health outcomes.