Web-based unfolding cases: a strategy to enhance and evaluate clinical reasoning skills.

PubMed

Johnson, Gail; Flagler, Susan

2013-10-01

Clinical reasoning involves the use of both analytical and nonanalytical intuitive cognitive processes. Fostering student development of clinical reasoning skills and evaluating student performance in this cognitive arena can challenge educators. The use of Web-based unfolding cases is proposed as a strategy to address these challenges. Unfolding cases mimic real-life clinical situations by presenting only partial clinical information in sequential segments. Students receive immediate feedback after submitting a response to a given segment. The student's comparison of the desired and submitted responses provides information to enhance the development of clinical reasoning skills. Each student's set of case responses are saved for the instructor in an individual-student electronic file, providing a record of the student's knowledge and thinking processes for faculty evaluation. For the example case given, the approaches used to evaluate individual components of clinical reasoning are provided. Possible future uses of Web-based unfolding cases are described. Copyright 2013, SLACK Incorporated.

METHODOLOGICAL QUALITY OF ECONOMIC EVALUATIONS ALONGSIDE TRIALS OF KNEE PHYSIOTHERAPY.

PubMed

García-Pérez, Lidia; Linertová, Renata; Arvelo-Martín, Alejandro; Guerra-Marrero, Carolina; Martínez-Alberto, Carlos Enrique; Cuéllar-Pompa, Leticia; Escobar, Antonio; Serrano-Aguilar, Pedro

2017-01-01

The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis. Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale. All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account. Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.

Black raspberries in cancer clinical trials: Past, present and future.

PubMed

Kresty, Laura A; Mallery, Susan R; Stoner, Gary D

Black raspberries (BRB) inhibit a broad range of cancers in preclinical models, including in vivo models of oral, esophageal, colon, breast and skin cancer. Promising preclinical results have led to clinical evaluations in cancer patients or patients at increased risk for cancer development. To summarize clinical investigations targeting cancer or precancerous lesions with BRB and discuss future directions. A thorough literature search was conducted through December 1, 2015 to identify all published studies evaluating BRB in cancer focused clinical trials. Research investigating BRB in clinical settings report positive effects on preneoplastic lesions or cancers of the oral cavity, esophagus and colon. BRB treatment resulted in: histologic regression of oral intraepithelial neoplasia associated with improved histologic grade and significantly reduced loss of heterozygosity at tumor suppressor gene loci, modulated genes linked to RNA processing and growth factor recycling; in the colon, BRB inhibited FAP-associated polyp progression, demethylated tumor suppressor genes and improved plasma cytokine profiles; in Barrett's patients, BRB consumption increased tissue levels of GST-pi and decreased 8-isoprostane, a marker of lipid peroxidation/oxidative stress. The precise dose, duration and optimum mode of BRB delivery for cancer inhibition remains to be fully elucidated. Common themes across studies support that BRB are anti-proliferative, anti- inflammatory, reduce oxidative stress and restore tumor suppressive activity. Future directions are included in the conclusions section.

Development and Evaluation of a Clinical Note Section Header Terminology

PubMed Central

Denny, Joshua C.; Miller, Randolph A.; Johnson, Kevin B.; Spickard, Anderson

2008-01-01

Clinical documentation is often expressed in natural language text, yet providers often use common organizations that segment these notes in sections, such as “history of present illness” or “physical examination.” We developed a hierarchical section header terminology, supporting mappings to LOINC and other vocabularies; it contained 1109 concepts and 4332 synonyms. Physicians evaluated it compared to LOINC and the Evaluation and Management billing schema using a randomly selected corpus of history and physical notes. Evaluated documents contained a median of 54 sections and 27 “major sections.” There were 16,196 total sections in the evaluation note corpus. The terminology contained 99.9% of the clinical sections; LOINC matched 77% of section header concepts and 20% of section header strings in those documents. The section terminology may enable better clinical note understanding and interoperability. Future development and integration into natural language processing systems is needed. PMID:18999303

Evidence of the economic benefit of clinical pharmacy services: 1996-2000.

PubMed

Schumock, Glen T; Butler, Melissa G; Meek, Patrick D; Vermeulen, Lee C; Arondekar, Bhakti V; Bauman, Jerry L

2003-01-01

We sought to summarize and assess original evaluations of the economic impact of clinical pharmacy services published from 1996-2000, and to provide recommendations and methodologic considerations for future research. A systematic literature search was conducted to identify articles that were then blinded and randomly assigned to reviewers who confirmed inclusion and abstracted key information. Results were compared with those of a similar review of literature published from 1988-1995. In the 59 included articles, the studies were conducted across a variety of practice sites that consisted of hospitals (52%), community pharmacies and clinics (41%), health maintenance organizations (3%), and long-term or intermediate care facilities (3%). They focused on a broad range of clinical pharmacy services such as general pharmacotherapeutic monitoring (47%), target drug programs (20%), disease management programs (10%), and patient education or cognitive services (10%). Compared with the studies of the previous review, a greater proportion of evaluations were conducted in community pharmacies or clinics, and the types of services evaluated tended to be more comprehensive rather than specialized. Articles were categorized by type of evaluation: 36% were considered outcome analyses, 24% full economic analyses, 17% outcome descriptions, 15% cost and outcome descriptions, and 8% cost analyses. Compared with the studies of the previous review, a greater proportion of studies in the current review used more rigorous study designs. Most studies reported positive financial benefits of the clinical pharmacy service evaluated. In 16 studies, a benefit:cost ratio was reported by the authors or was able to be calculated by the reviewers (these ranged from 1.7:1-17.0:1, median 4.68:1). The body of literature from this 5-year period provides continued evidence of the economic benefit of clinical pharmacy services. Although the quality of study design has improved, whenever possible, future evaluations of this type should incorporate methodologies that will further enhance the strength of evidence of this literature and the conclusions that may be drawn from it.

A design thinking approach to evaluating interprofessional education.

PubMed

Cahn, Peter S; Bzowyckyj, Andrew; Collins, Lauren; Dow, Alan; Goodell, Kristen; Johnson, Alex F; Klocko, David; Knab, Mary; Parker, Kathryn; Reeves, Scott; Zierler, Brenda K

2016-05-01

The complex challenge of evaluating the impact of interprofessional education (IPE) on patient and community health outcomes is well documented. Recently, at the Radcliffe Institute for Advanced Study in the United States, leaders in health professions education met to help generate a direction for future IPE evaluation research. Participants followed the stages of design thinking, a process for human-centred problem solving, to reach consensus on recommendations. The group concluded that future studies should focus on measuring an intermediate step between learning activities and patient outcomes. Specifically, knowing how IPE-prepared students and preceptors influence the organisational culture of a clinical site as well as how the culture of clinical sites influences learners' attitudes about collaborative practice will demonstrate the value of educational interventions. With a mixed methods approach and an appreciation for context, researchers will be able to identify the factors that foster effective collaborative practice and, by extension, promote patient-centred care.

Appraising the methodological quality of the clinical practice guideline for diabetes mellitus using the AGREE II instrument: a methodological evaluation.

PubMed

Radwan, Mahmoud; Akbari Sari, Ali; Rashidian, Arash; Takian, Amirhossein; Abou-Dagga, Sanaa; Elsous, Aymen

2017-02-01

To evaluate the methodological quality of the Palestinian Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological evaluation. A cross-cultural adaptation framework was followed to translate and develop a standardised Translated Arabic Version of the AGREE II. Palestinian Primary Healthcare Centres. Sixteen appraisers independently evaluated the Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological quality of diabetic guideline. The Translated Arabic Version of the AGREE II showed an acceptable reliability and validity. Internal consistency ranged between 0.67 and 0.88 (Cronbach's α). Intra-class coefficient among appraisers ranged between 0.56 and 0.88. The quality of this guideline is low. Both domains 'Scope and Purpose' and 'Clarity of Presentation' had the highest quality scores (66.7% and 61.5%, respectively), whereas the scores for 'Applicability', 'Stakeholder Involvement', 'Rigour of Development' and 'Editorial Independence' were the lowest (27%, 35%, 36.5%, and 40%, respectively). The findings suggest that the quality of this Clinical Practice Guideline is disappointingly low. To improve the quality of current and future guidelines, the AGREE II instrument is extremely recommended to be incorporated as a gold standard for developing, evaluating or updating the Palestinian Clinical Practice Guidelines. Future guidelines can be improved by setting specific strategies to overcome implementation barriers with respect to economic considerations, engaging of all relevant end-users and patients, ensuring a rigorous methodology for searching, selecting and synthesising the evidences and recommendations, and addressing potential conflict of interests within the development group.

Procedural training and assessment of competency utilizing simulation.

PubMed

Sawyer, Taylor; Gray, Megan M

2016-11-01

This review examines the current environment of neonatal procedural learning, describes an updated model of skills training, defines the role of simulation in assessing competency, and discusses potential future directions for simulation-based competency assessment. In order to maximize impact, simulation-based procedural training programs should follow a standardized and evidence-based approach to designing and evaluating educational activities. Simulation can be used to facilitate the evaluation of competency, but must incorporate validated assessment tools to ensure quality and consistency. True competency evaluation cannot be accomplished with simulation alone: competency assessment must also include evaluations of procedural skill during actual clinical care. Future work in this area is needed to measure and track clinically meaningful patient outcomes resulting from simulation-based training, examine the use of simulation to assist physicians undergoing re-entry to practice, and to examine the use of procedural skills simulation as part of a maintenance of competency and life-long learning. Copyright © 2016 Elsevier Inc. All rights reserved.

Health benefits and health claims of probiotics: bridging science and marketing.

PubMed

Rijkers, Ger T; de Vos, Willem M; Brummer, Robert-Jan; Morelli, Lorenzo; Corthier, Gerard; Marteau, Philippe

2011-11-01

Health claims for probiotics are evaluated by the Panel on Dietetic Products, Nutrition and Allergies of the European Food Safety Authority. Despite a substantial amount of basic and clinical research on the beneficial effects of probiotics, all of the evaluated claim applications thus far have received a negative opinion. With the restrictions on the use of clinical endpoints, validated biomarkers for gut health and immune health in relation to reduction in disease risk are needed. Clear-cut criteria for design as well as evaluation of future studies are needed. An open dialogue between basic and clinical scientists, regulatory authorities, food and nutrition industry, and consumers could bridge the gap between science and marketing of probiotics.

Experiences from an interprofessional student-assisted chronic disease clinic.

PubMed

Frakes, Kerrie-Anne; Brownie, Sharon; Davies, Lauren; Thomas, Janelle; Miller, Mary-Ellen; Tyack, Zephanie

2014-11-01

Faced with significant health and workforce challenges in the region, the Central Queensland Health Service District (CQHSD) commenced a student-assisted clinical service. The Capricornia Allied Health Partnership (CAHP) is an interprofessional clinical placement program in which pre-entry students from exercise physiology, nutrition and dietetics, occupational therapy, pharmacy, podiatry and social work are embedded in a collaborative chronic disease service delivery model. The model coordinates multiple student clinical placements to: address service delivery gaps for previously underserved people with chronic disease in need of early intervention and management; provide an attractive clinical placement opportunity for students that will potentially lead to future recruitment success, and demonstrate leadership in developing future health workforce trainees to attain appropriate levels of interprofessional capacity. The CAHP clinic commenced student placements and client services in February 2010. This report provides early evaluative information regarding student experiences included self-reported changes in practice.

The Health Clinic. School of the Future: Houston.

ERIC Educational Resources Information Center

Iscoe, Louise

The Hogg Foundation for Mental Health created the School of the Future (SoF) project to enable selected Texas schools to coordinate and implement school-based social and health services on their campuses and to demonstrate the effectiveness of this method of service delivery by evaluating the project. SoF operated in four urban sites in Texas,…

Healthcare provider education to support integration of pharmacogenomics in practice: the eMERGE Network experience

PubMed Central

Rohrer Vitek, Carolyn R; Abul-Husn, Noura S; Connolly, John J; Hartzler, Andrea L; Kitchner, Terrie; Peterson, Josh F; Rasmussen, Luke V; Smith, Maureen E; Stallings, Sarah; Williams, Marc S; Wolf, Wendy A; Prows, Cynthia A

2017-01-01

Ten organizations within the Electronic Medical Records and Genomics Network developed programs to implement pharmacogenomic sequencing and clinical decision support into clinical settings. Recognizing the importance of informed prescribers, a variety of strategies were used to incorporate provider education to support implementation. Education experiences with pharmacogenomics are described within the context of each organization's prior involvement, including the scope and scale of implementation specific to their Electronic Medical Records and Genomics projects. We describe common and distinct education strategies, provide exemplars and share challenges. Lessons learned inform future perspectives. Future pharmacogenomics clinical implementation initiatives need to include funding toward implementing provider education and evaluating outcomes. PMID:28639489

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

Training pediatric clinical pharmacology and therapeutics specialists of the future: the needs, the reality, and opportunities for international networking.

PubMed

Gazarian, Madlen

2009-01-01

In recent years there has been a rapid and marked increase in global recognition of the need for better medicines for children, with various initiatives being implemented at global and regional levels. These exciting developments are matched by recognition of the need to build greater capacity in the field of pediatric clinical pharmacology and therapeutics to help deliver on the promise of better medicines for children. A range of pediatric medicines researchers, educators, clinical therapeutics practitioners, and experts in drug evaluation, regulation, and broader medicines policy are needed on a larger scale, in both developed and developing world settings. The current and likely future training needs to meet these diverse challenges, the current realities of trying to meet such needs, and the opportunities for international networking to help meet future training needs are discussed from a global perspective.

Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders

PubMed Central

Kalali, Amir; West, Mark; Walling, David; Hilt, Dana; Engelhardt, Nina; Alphs, Larry; Loebel, Antony; Vanover, Kim; Atkinson, Sarah; Opler, Mark; Sachs, Gary; Nations, Kari; Brady, Chris

2016-01-01

This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit 2014, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. The majority of those polled endorse the value of monitoring data. Case examples of current data quality methodology are presented and discussed. Perspectives of pharmaceutical companies and trial sites regarding data quality monitoring are presented. Potential future developments in CNS data quality monitoring are described. Increased utilization of biomarkers as objective outcomes and for patient selection is considered to be the most impactful development in data quality monitoring over the next 10 years. Additional future outcome measures and patient selection approaches are discussed. PMID:27413584

Hidden benefits of a peer-mentored 'Hospital Orientation Day': first-year medical students' perspectives.

PubMed

Barker, Thomas A; Ngwenya, Nothando; Morley, David; Jones, Ellen; Thomas, Cathryn P; Coleman, Jamie J

2012-01-01

Entering the clinical environment is potentially stressful for junior medical students. We evaluated first-year medical student feedback on a peer-mentored 'Hospital Orientation Day' designed to provide insight into future clinical training. Using a mixed methodology approach data were collected from first-year medical students. Responses to a questionnaire were used to develop a topic guide for focus groups held the next academic year. The questionnaire was completed by 230 first-year students and 32 second years participated in the interviews. Thematic analysis was used to draw conclusions. Analysis of questionnaire responses indicated that students gained insight into future learning. Focus groups then generated five themes: (1) entering the hospital without fear, (2) linking the present with the future, (3) understanding the culture of learning in the clinical years, (4) a 'Backstage Pass' to the clinical world and (5) peer mentors make or break the day. Using peer mentors during the Hospital Orientation Day allowed insight into future learning. We highlight the importance of student Mentors in the success of hospital orientation. To maximise the benefits for first years, we recommend a mentor selection procedure, mentor training opportunities and incentives to optimise mentor performance.

[Evaluation of the first training on clinical research methodology in Chile].

PubMed

Espinoza, Manuel; Cabieses, Báltica; Pedreros, César; Zitko, Pedro

2011-03-01

This paper describes the evaluation of the first training on clinical research methodology in Chile (EMIC-Chile) 12 months after its completion. An online survey was conducted for students and the Delphi method was used for the teaching team. Among the students, the majority reported that the program had contributed to their professional development and that they had shared some of the knowledge acquired with colleagues in their workplace. Forty-one percent submitted a project to obtain research funding through a competitive grants process once they had completed the course. Among the teachers, the areas of greatest interest were the communication strategy, teaching methods, the characteristics of the teaching team, and potential strategies for making the EMIC-Chile permanent in the future. This experience could contribute to future research training initiatives for health professionals. Recognized challenges are the involvement of nonmedical professions in clinical research, the complexities associated with the distance learning methodology, and the continued presence of initiatives of this importance at the national and regional level.

Usability Evaluation of NLP-PIER: A Clinical Document Search Engine for Researchers.

PubMed

Hultman, Gretchen; McEwan, Reed; Pakhomov, Serguei; Lindemann, Elizabeth; Skube, Steven; Melton, Genevieve B

2017-01-01

NLP-PIER (Natural Language Processing - Patient Information Extraction for Research) is a self-service platform with a search engine for clinical researchers to perform natural language processing (NLP) queries using clinical notes. We conducted user-centered testing of NLP-PIER's usability to inform future design decisions. Quantitative and qualitative data were analyzed. Our findings will be used to improve the usability of NLP-PIER.

Cervical pessaries for prevention of spontaneous preterm birth: past, present and future

PubMed Central

Arabin, B; Alfirevic, Z

2013-01-01

This Review describes the rationale for the use of cervical pessaries to prevent spontaneous preterm birth and their gradual introduction into clinical practice, discusses technical aspects of the more commonly used designs and provides guidance for their use and future evaluation. Possible advantages of cervical pessaries include the easy, ‘one-off’ application, good side-effect profile, good patient tolerance and relatively low cost compared with current alternatives. Use of transvaginal sonography to assess cervical length in the second trimester allows much better selection of patients who may benefit from the use of a cervical pessary, but future clinical trials are needed to establish clearly the role of pessaries as a preterm birth prevention strategy worldwide. PMID:23775862

Longitudinal construct validity: establishment of clinical meaning in patient evaluative instruments.

PubMed

Liang, M H

2000-09-01

Although widely used and reported in research for the evaluation of groups, measures of health status and health-related quality of life have had little application in clinical practice for the assessment of individual patients. One of the principal barriers is the demonstration that these measures add clinically significant information to measures of function or symptoms alone. Here, we review the methods for evaluation of construct validity in longitudinal studies and make recommendations for nomenclature, reporting of study results, and future research agenda. Analytical review. The terms "sensitivity" and "responsiveness" have been used interchangeably, and there are few studies that evaluate the extent to which health status or health-related quality-of life measures capture clinically important changes ("responsiveness"). Current methods of evaluating responsiveness are not standardized or evaluated. Approaches for the assessment of a clinically significant or meaningful change are described; rather than normative information, however, standardized transition questions are proposed. They would be reported routinely and as separate axes of description to capture individual perceptions. Research in methods to assess the subject's evaluation of the importance and magnitude of a measured change are critical if health status and health-related quality-of-life measures are to have an impact on patient care.

Robotics in urological surgery: evolution, current status and future perspectives.

PubMed

Sivaraman, A; Sanchez-Salas, R; Prapotnich, D; Barret, E; Mombet, A; Cathala, N; Rozet, F; Galiano, M; Cathelineau, X

2015-09-01

Robotic surgery is rapidly evolving and has become an essential part of surgical practice in several parts of the world. Robotic technology will expand globally and most of the surgeons around the world will have access to surgical robots in the future. It is essential that we are updated about the outcomes of robot assisted surgeries which will allow everyone to develop an unbiased opinion on the clinical utility of this innovation. In this review we aim to present the evolution, objective evaluation of clinical outcomes and future perspectives of robot assisted urologic surgeries. A systematic literature review of clinical outcomes of robotic urological surgeries was made in the PUBMED. Randomized control trials, cohort studies and review articles were included. Moreover, a detailed search in the web based search engine was made to acquire information on evolution and evolving technologies in robotics. The present evidence suggests that the clinical outcomes of the robot assisted urologic surgeries are comparable to the conventional open surgical and laparoscopic results and are associated with fewer complications. However, long term results are not available for all the common robotic urologic surgeries. There are plenty of novel developments in robotics to be available for clinical use in the future. Robotic urologic surgery will continue to evolve in the future. We should continue to critically analyze whether the advances in technology and the higher cost eventually translates to improved overall surgical performance and outcomes. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Evaluating impact of clinical guidelines using a realist evaluation framework.

PubMed

Reddy, Sandeep; Wakerman, John; Westhorp, Gill; Herring, Sally

2015-12-01

The Remote Primary Health Care Manuals (RPHCM) project team manages the development and publication of clinical protocols and procedures for primary care clinicians practicing in remote Australia. The Central Australian Rural Practitioners Association Standard Treatment Manual, the flagship manual of the RPHCM suite, has been evaluated for accessibility and acceptability in remote clinics three times in its 20-year history. These evaluations did not consider a theory-based framework or a programme theory, resulting in some limitations with the evaluation findings. With the RPHCM having an aim of enabling evidence-based practice in remote clinics and anecdotally reported to do so, testing this empirically for the full suite is vital for both stakeholders and future editions of the RPHCM. The project team utilized a realist evaluation framework to assess how, why and for what the RPHCM were being used by remote practitioners. A theory regarding the circumstances in which the manuals have and have not enabled evidence-based practice in the remote clinical context was tested. The project assessed this theory for all the manuals in the RPHCM suite, across government and aboriginal community-controlled clinics, in three regions of Australia. Implementing a realist evaluation framework to generate robust findings in this context has required innovation in the evaluation design and adaptation by researchers. This article captures the RPHCM team's experience in designing this evaluation. © 2015 John Wiley & Sons, Ltd.

Essentials of Pediatric Emergency Medicine Fellowship: Part 3: Clinical Education and Experience.

PubMed

Mittiga, Matthew R; Nagler, Joshua; Eldridge, Charles D; Ishimine, Paul; Zuckerbraun, Noel S; McAneney, Constance M

2016-07-01

This article is the third in a 7-part series that aims to comprehensively describe the current state and future directions of pediatric emergency medicine fellowship training from the essential requirements to considerations for successfully administering and managing a program to the careers that may be anticipated upon program completion. This article focuses on the clinical aspects of fellowship training including the impact of the clinical environment, modalities for teaching and evaluation, and threats and opportunities in clinical education.

Patient characteristics influencing evaluation of written medicine information: lessons for patient education.

PubMed

Koo, Michelle M; Krass, Ines; Aslani, Parisa

2005-09-01

Written medicine information (WMI) is considered an important component of patient education. Despite the wealth of information on many aspects of WMI, there is a paucity of studies examining how patient characteristics influence use and evaluation of WMI. To investigate the influence of patient characteristics on the evaluation and intended future use of consumer medicine information (CMI), a form of WMI. A questionnaire was administered to patients from 3 rheumatology/pain clinics in teaching hospitals and 40 community pharmacies. The questionnaire examined patients' perceptions of CMI (comprehension, perceived usefulness, design rating) and likelihood of using CMI in the future. Information on patient characteristics (demographic data, health literacy level) was also collected. Multiple regression analysis was used to examine associations between patient characteristics and their evaluation and intended future use of CMI. A total of 479 patients participated. Comprehension of CMI was associated with speaking primarily English at home, having attained secondary education or higher, and having adequate health literacy levels. Perceived usefulness of CMI was influenced by age and number of medications. Design rating was influenced by type of CMI, patient age, gender, and highest level of education. Intended future use was affected by health literacy level. In addition to individual patient characteristics, overall comprehension and perceived usefulness of CMI also influenced its intended future use. Patient characteristics were found to influence evaluation and intended future use of CMI. These findings should be taken into consideration in future research, development of WMI, and education of patients in everyday practice.

Feasibility of Automatic Extraction of Electronic Health Data to Evaluate a Status Epilepticus Clinical Protocol.

PubMed

Hafeez, Baria; Paolicchi, Juliann; Pon, Steven; Howell, Joy D; Grinspan, Zachary M

2016-05-01

Status epilepticus is a common neurologic emergency in children. Pediatric medical centers often develop protocols to standardize care. Widespread adoption of electronic health records by hospitals affords the opportunity for clinicians to rapidly, and electronically evaluate protocol adherence. We reviewed the clinical data of a small sample of 7 children with status epilepticus, in order to (1) qualitatively determine the feasibility of automated data extraction and (2) demonstrate a timeline-style visualization of each patient's first 24 hours of care. Qualitatively, our observations indicate that most clinical data are well labeled in structured fields within the electronic health record, though some important information, particularly electroencephalography (EEG) data, may require manual abstraction. We conclude that a visualization that clarifies a patient's clinical course can be automatically created using the patient's electronic clinical data, supplemented with some manually abstracted data. Future work could use this timeline to evaluate adherence to status epilepticus clinical protocols. © The Author(s) 2015.

From selection hits to clinical leads: progress in aptamer discovery

PubMed Central

Maier, Keith E; Levy, Matthew

2016-01-01

Aptamers were discovered more than 25 years ago, yet only one has been approved by the US Food and Drug Administration to date. With some noteworthy advances in their chemical design and the enzymes we use to make them, aptamers and aptamer-based therapeutics have seen a resurgence in interest. New aptamer drugs are being approved for clinical evaluation, and it is certain that we will see increasingly more aptamers and aptamer-like drugs in the future. In this review, we will discuss the production of aptamers with an emphasis on the advances and modifications that enabled early aptamers to succeed in clinical trials as well as those that are likely to be important for future generations of these drugs. PMID:27088106

Developing future clinical leaders for quality improvement: experience from a London children's hospital.

PubMed

Runnacles, Jane; Moult, Beki; Lachman, Peter

2013-11-01

Medical training does not necessarily prepare graduates for the real world of healthcare in which continual improvement is required. Doctors in postgraduate training (DrPGT) rarely have the opportunity to develop skills to implement changes where they work. Paradoxically they are often best placed to identify safety and quality concerns and can innovate across organisational boundaries. In order to address this, educational programmes require a supportive educational environment and should include experiential learning on a safety and quality project, alongside teaching of quality improvement (QI) knowledge and systems theory. Enabling Doctors in Quality Improvement and Patient Safety (EQuIP) has been designed for DrPGT at a London children's hospital. The aim is to prepare trainees for the future of continual improvement to ensure safe and effective services are developed through effective clinical microsystems. This paper describes the rationale and design of EQuIP with evaluation built in the evolving programme. EQuIP supports DrPGTs through a QI project within their department, aligned to the Great Ormond Street NHS Foundation Trust's objectives. This changes the way DrPGTs view healthcare as they become quality champions for their department. A three-level approach to the programme is described. The innovation involves a peer-designed programme while being work-based, delivering organisational strategies. Results of the preprogramme and postprogramme evaluations demonstrate an improvement in knowledge, skills and attitudes. Benefits to both the DrPGTs and the organisation are emphasised and key factors to achieve success and barriers identified by the participants. The design and evaluation of EQuIP may inform similar educational programmes in other organisations. This capacity building is crucial to ensure that future clinical leaders have the skills and motivation to improve the effectiveness of clinical microsystems.

A Brief Review of OPT101 Sensor Application in Near-Infrared Spectroscopy Instrumentation for Intensive Care Unit Clinics

PubMed Central

Li, Ting; Zhong, Fulin; Pan, Boan; Li, Zebin; Huang, Chong; Deng, Zishan

2017-01-01

The optoelectronic sensor OPT101 have merits in advanced optoelectronic response characteristics at wavelength range for medical near-infrared spectroscopy and small-size chip design with build-in trans-impedance amplifier. Our lab is devoted to developing a series of portable near-infrared spectroscopy (NIRS) devices embedded with OPT101 for applications in intensive care unit clinics, based on NIRS principle. Here we review the characteristics and advantages of OPT101 relative to clinical NIRS instrumentation, and the most recent achievements, including early-diagnosis and therapeutic effect evaluation of thrombus, noninvasive monitoring of patients' shock severity, and fatigue evaluation. The future prospect on OPT101 improvements in noninvasive clinical applications is also discussed. PMID:28757564

Key data elements for use in cost-utility modeling of biological treatments for rheumatoid arthritis.

PubMed

Ganz, Michael L; Hansen, Brian Bekker; Valencia, Xavier; Strandberg-Larsen, Martin

2015-05-01

Economic evaluation is becoming more common and important as new biologic therapies for rheumatoid arthritis (RA) are developed. While much has been published about how to design cost-utility models for RA to conduct these evaluations, less has been written about the sources of data populating those models. The goal is to review the literature and to provide recommendations for future data collection efforts. This study reviewed RA cost-utility models published between January 2006 and February 2014 focusing on five key sources of data (health-related quality-of-life and utility, clinical outcomes, disease progression, course of treatment, and healthcare resource use and costs). It provided recommendations for collecting the appropriate data during clinical and other studies to support modeling of biologic treatments for RA. Twenty-four publications met the selection criteria. Almost all used two steps to convert clinical outcomes data to utilities rather than more direct methods; most did not use clinical outcomes measures that captured absolute levels of disease activity and physical functioning; one-third of them, in contrast with clinical reality, assumed zero disease progression for biologic-treated patients; little more than half evaluated courses of treatment reflecting guideline-based or actual clinical care; and healthcare resource use and cost data were often incomplete. Based on these findings, it is recommended that future studies collect clinical outcomes and health-related quality-of-life data using appropriate instruments that can convert directly to utilities; collect data on actual disease progression; be designed to capture real-world courses of treatment; and collect detailed data on a wide range of healthcare resources and costs.

Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation.

PubMed

Evans, Scott R; Follmann, Dean

2016-01-01

In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the totality of the evidence in ways that clinical trials consumers---patients, physicians, insurers---find transparent and allow for informed benefit:risk decision-making. The current approach to the analysis of clinical trials is to analyze efficacy and safety separately and then combine these analyses into a benefit:risk assessment. Many assume that this will effectively describe the impact on patients. But this approach is suboptimal for evaluating the totality of effects on patients. We discuss methods for benefit:risk assessment that have greater pragmatism than methods that separately analyze efficacy and safety. These include the concepts of within-patient analyses and composite benefit:risk endpoints with a goal of understanding how to analyze one patient before trying to figure out how to analyze many. We discuss the desirability of outcome ranking (DOOR) and introduce the partial credit strategy using an example in a clinical trial evaluating the effects of a new antibiotic. As part of the example we introduce a strategy to engage patients as a resource to inform benefit:risk analyses consistent with the goal of measuring and weighing outcomes that are most important from the patient's perspective. We describe a broad vision for the future of clinical trials consistent with increased pragmatism. Greater focus on using endpoints to analyze patients rather than patients to analyze endpoints particularly in late-phase/stage clinical trials is an important part of this vision.

Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation

PubMed Central

Evans, Scott R.; Follmann, Dean

2016-01-01

In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the totality of the evidence in ways that clinical trials consumers---patients, physicians, insurers---find transparent and allow for informed benefit:risk decision-making. The current approach to the analysis of clinical trials is to analyze efficacy and safety separately and then combine these analyses into a benefit:risk assessment. Many assume that this will effectively describe the impact on patients. But this approach is suboptimal for evaluating the totality of effects on patients. We discuss methods for benefit:risk assessment that have greater pragmatism than methods that separately analyze efficacy and safety. These include the concepts of within-patient analyses and composite benefit:risk endpoints with a goal of understanding how to analyze one patient before trying to figure out how to analyze many. We discuss the desirability of outcome ranking (DOOR) and introduce the partial credit strategy using an example in a clinical trial evaluating the effects of a new antibiotic. As part of the example we introduce a strategy to engage patients as a resource to inform benefit:risk analyses consistent with the goal of measuring and weighing outcomes that are most important from the patient’s perspective. We describe a broad vision for the future of clinical trials consistent with increased pragmatism. Greater focus on using endpoints to analyze patients rather than patients to analyze endpoints particularly in late-phase/stage clinical trials is an important part of this vision. PMID:28435515

Clinical value of selective serial sectioning of laryngectomy specimens.

PubMed Central

Browning, G. G.

1976-01-01

A simple routine pathology method for examining laryngectomy specimens has been presented which (1) gives the clinician information regarding the probability of total excision of the tumour; (2) allows more accurate staging of laryngeal tumours; (3) will act as a basis for evaluation of preoperative investigations and future clinical trials of treatment. Images Fig 1 Fig 2 PMID:785476

Social justice as a framework for undergraduate community health clinical experiences in the United States.

PubMed

Boutain, Doris M

2008-01-01

Educating future registered nurses for social justice is an urgent, yet complex undertaking in undergraduate education. Although the need for social justice education is often highlighted, few articles describe practical teaching strategies for ensuring that undertaking. The purpose of this article is to illustrate how a curricular focus on social justice framed and supported the development of a clinical evaluation tool for undergraduate community health clinical experiences. First, social justice is defined and its relationship to baccalaureate nursing education explained. Then a description is provided of how social justice was highlighted in the vision, curriculum, and community health clinical evaluation tool of a College of Nursing. The article subsequently showcases the content and evaluation of students' journal entries about social justice. The development of the social justice component presented in this article may be useful to nurse educators striving to match theory and practice in the evaluation of social justice in students' community health experience.

Evaluation and justification of clinical pharmacy services.

PubMed

Anderson, Scott V; Schumock, Glen T

2009-12-01

Pharmacy managers often must justify clinical pharmacy services (CPSs). This can be done by generalizing evidence from the literature or by conducting local evaluations. In either case, it is important that the clinical, humanistic or economic benefits of CPSs are considered, and limitations of the studies recognized. The basic model for the evaluation of CPSs includes the consideration of costs and outcomes, as well as the inclusion of a comparator group. Recent systematic reviews and individual studies provide good evidence regarding the value of CPSs, and are discussed here. Benefit-to-cost ratios of selected CPSs are also provided. While much of the evidence for CPSs has been conducted in the hospital setting, in the future, CPS expansion will occur in ambulatory care settings and will be benefited by healthcare reform efforts.

The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?*.

PubMed

Opal, Steven M; Dellinger, R Phillip; Vincent, Jean-Louis; Masur, Henry; Angus, Derek C

2014-07-01

The developmental pipeline for novel therapeutics to treat sepsis has diminished to a trickle compared to previous years of sepsis research. While enormous strides have been made in understanding the basic molecular mechanisms that underlie the pathophysiology of sepsis, a long list of novel agents have now been tested in clinical trials without a single immunomodulating therapy showing consistent benefit. The only antisepsis agent to successfully complete a phase III clinical trial was human recumbent activated protein C. This drug was taken off the market after a follow-up placebo-controlled trial (human recombinant activated Protein C Worldwide Evaluation of Severe Sepsis and septic Shock [PROWESS SHOCK]) failed to replicate the favorable results of the initial registration trial performed ten years earlier. We must critically reevaluate our basic approach to the preclinical and clinical evaluation of new sepsis therapies. We selected the major clinical studies that investigated interventional trials with novel therapies to treat sepsis over the last 30 years. Phase II and phase III trials investigating new treatments for sepsis and editorials and critiques of these studies. Selected manuscripts and clinical study reports were analyzed from sepsis trials. Specific shortcomings and potential pit falls in preclinical evaluation and clinical study design and analysis were reviewed and synthesized. After review and discussion, a series of 12 recommendations were generated with suggestions to guide future studies with new treatments for sepsis. We need to improve our ability to define appropriate molecular targets for preclinical development and develop better methods to determine the clinical value of novel sepsis agents. Clinical trials must have realistic sample sizes and meaningful endpoints. Biomarker-driven studies should be considered to categorize specific "at risk" populations most likely to benefit from a new treatment. Innovations in clinical trial design such as parallel crossover design, alternative endpoints, or adaptive trials should be pursued to improve the outlook for future interventional trials in sepsis.

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

PubMed

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

Future directions in the use of dental implants.

PubMed

Bloem, T J

1989-10-01

Future development in implant prosthodontics should be based on the fundamentals of sound research and reliable clinical implementation. The goals should be to research the safety and efficacy of implants with regard to materials, host receptor site and interfacial zone; to develop acceptable uniform standards of evaluation; and to submit findings to scientific methods of analysis in determining benefit-to-risk factors. This presentation will offer a glimpse at some current developments in basic and clinical research focusing on studies in biocompatability and host acceptance; the implant-tissue interface; processes in osteogenesis related to vascularization of host sites; and bioengineering studies related to stress analysis and dimensional accuracy of impression systems for implants. The presentation will further describe future direction in research, training and implementation of services through development of an interdisciplinary team. A center is proposed to address the need for combined efforts in clinical and basic science research, the broad scope of implant utilization, and the teaching of implant procedures within an academic setting and to our colleagues.

Recent advances and future directions in mantle cell lymphoma research: report of the 2016 mantle cell lymphoma consortium workshop.

PubMed

Kahl, Brad S; Dreyling, Martin; Gordon, Leo I; Quintanilla-Martinez, Leticia; Sotomayor, Eduardo M

2017-07-01

Mantle cell lymphoma (MCL) is an aggressive B-cell non-Hodgkin lymphoma typically associated with the t(11;14) chromosomal translocation, resulting in overexpression of cyclin D1. Although MCL is associated with clinical heterogeneity, outcomes are generally poor and no standard treatment has been established. However, the recent approval of ibrutinib provides a new therapeutic option. Moreover, recent clinical trials have provided new perspectives on the relative efficacy and safety of various approaches for both transplant-eligible and transplant-ineligible patients. Multiple novel strategies are being evaluated in the treatment of MCL, including both targeted agents and cellular immunotherapies. At the Lymphoma Research Foundation's 12th MCL Workshop, researchers gathered to discuss research findings, clinical trial results, and future directions related to MCL, its biology, and its treatment. This manuscript, which includes a summary of each presentation, aims to review recent findings in MCL research and highlight potential areas for future study.

Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research.

PubMed

Heisler, Michele

2010-06-01

Much of diabetes care needs to be carried out by patients between office visits with their health care providers. Yet, many patients face difficulties carrying out these tasks. In addition, many adults with diabetes cannot count on effective support from their families and friends to help them with their self-management. Peer support programmes are a promising approach to enhance social and emotional support, assist patients in daily management and living with diabetes and promote linkages to clinical care. This background paper provides a brief overview of different approaches to mobilize peer support for diabetes self-management support, discusses evidence to date on the effectiveness of each of these models, highlights logistical and evaluation issues for each model and concludes with a discussion of directions for future research in this area.

Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research

PubMed Central

2010-01-01

Much of diabetes care needs to be carried out by patients between office visits with their health care providers. Yet, many patients face difficulties carrying out these tasks. In addition, many adults with diabetes cannot count on effective support from their families and friends to help them with their self-management. Peer support programmes are a promising approach to enhance social and emotional support, assist patients in daily management and living with diabetes and promote linkages to clinical care. This background paper provides a brief overview of different approaches to mobilize peer support for diabetes self-management support, discusses evidence to date on the effectiveness of each of these models, highlights logistical and evaluation issues for each model and concludes with a discussion of directions for future research in this area. PMID:19293400

[Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

PubMed

Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

2015-09-01

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

PODCAST: From Lost in Translation to Paradise Found: Enabling Protein Biomarker Method Transfer by Mass Spectrometry | Office of Cancer Clinical Proteomics Research

Cancer.gov

Translation of novel biomarkers into clinical care for the evaluation of therapeutic safety and efficacy has been slow, partly attributable to the cost and complexity of immunoassay development.  The potential for liquid chromatography-tandem mass spectrometry (LC-MS/MS) to streamline the translation of novel protein biomarkers is profound.  Drs. Henry Rodriguez and Andrew Hoofnagle discuss what the future may be for clinical proteomics. This is an American Association for Clinical Chemistry (AACC) podcast.

Clinical Space Medicine Products as Developed by the Medical Operations Support Team (MOST)

NASA Technical Reports Server (NTRS)

Polk, James D.; Doerr, Harold K.; Hurst, Victor W., IV; Schmid, Josef

2007-01-01

Medical Operations Support Team (MOST) is introducing/integrating teaching practices associated with high fidelity human patient simulation into the NASA culture, in particular, into medical training sessions and medical procedure evaluations. Current/Future Products iclude: a) Development of Sub-optimal Airway Protocols for the International Space Station (ISS) using the ILMA; b) Clinical Core Competency Training for NASA Flight Surgeons (FS); c) Post-Soyuz Landing Clinical Training for NASA FS; d) Experimental Integrated Training for Astronaut Crew Medical Officers and NASA FS; and e) Private Clinical Refresher Training.

The Importance of Considering Clinical Utility in the Construction of a Diagnostic Manual.

PubMed

Mullins-Sweatt, Stephanie N; Lengel, Gregory J; DeShong, Hilary L

2016-01-01

The development of major diagnostic manuals primarily has been guided by construct validity rather than clinical utility. The purpose of this article is to summarize recent research and theory examining the importance of clinical utility when constructing and evaluating a diagnostic manual. We suggest that construct validity is a necessary but not sufficient criterion for diagnostic constructs. This article discusses components of clinical utility and how these have applied to the current and forthcoming diagnostic manuals. Implications and suggestions for future research are provided.

The Time Is Now: Using Graduates' Practice Data to Drive Medical Education Reform.

PubMed

Triola, Marc M; Hawkins, Richard E; Skochelak, Susan E

2018-06-01

Medical educators are not yet taking full advantage of the publicly available clinical practice data published by federal, state, and local governments, which can be attributed to individual physicians and evaluated in the context of where they attended medical school and residency training. Understanding how graduates fare in actual practice, both in terms of the quality of the care they provide and the clinical challenges they face, can aid educators in taking an evidence-based approach to medical education. Although in their infancy, efforts to link clinical outcomes data to educational process data hold the potential to accelerate medical education research and innovation. This approach will enable unprecedented insight into the long-term impact of each stage of medical education on graduates' future practice. More work is needed to determine best practices, but the barrier to using these public data is low, and the potential for early results is immediate. Using practice data to evaluate medical education programs can transform how the future physician workforce is trained and better align continuously learning medical education and health care systems.

Patient reported outcomes and patient empowerment in clinical genetics services.

PubMed

McAllister, M; Dearing, A

2015-08-01

Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS. © 2014 The Authors. Clinical Genetics published by John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Review on Technical and Clinical Impact of Microsoft Kinect on Physical Therapy and Rehabilitation

PubMed Central

Mousavi Hondori, Hossein; Khademi, Maryam

2014-01-01

This paper reviews technical and clinical impact of the Microsoft Kinect in physical therapy and rehabilitation. It covers the studies on patients with neurological disorders including stroke, Parkinson's, cerebral palsy, and MS as well as the elderly patients. Search results in Pubmed and Google scholar reveal increasing interest in using Kinect in medical application. Relevant papers are reviewed and divided into three groups: (1) papers which evaluated Kinect's accuracy and reliability, (2) papers which used Kinect for a rehabilitation system and provided clinical evaluation involving patients, and (3) papers which proposed a Kinect-based system for rehabilitation but fell short of providing clinical validation. At last, to serve as technical comparison to help future rehabilitation design other sensors similar to Kinect are reviewed. PMID:27006935

A Review on Technical and Clinical Impact of Microsoft Kinect on Physical Therapy and Rehabilitation.

PubMed

Mousavi Hondori, Hossein; Khademi, Maryam

2014-01-01

This paper reviews technical and clinical impact of the Microsoft Kinect in physical therapy and rehabilitation. It covers the studies on patients with neurological disorders including stroke, Parkinson's, cerebral palsy, and MS as well as the elderly patients. Search results in Pubmed and Google scholar reveal increasing interest in using Kinect in medical application. Relevant papers are reviewed and divided into three groups: (1) papers which evaluated Kinect's accuracy and reliability, (2) papers which used Kinect for a rehabilitation system and provided clinical evaluation involving patients, and (3) papers which proposed a Kinect-based system for rehabilitation but fell short of providing clinical validation. At last, to serve as technical comparison to help future rehabilitation design other sensors similar to Kinect are reviewed.

Electronic decision protocols for ART patient triaging to expand access to HIV treatment in South Africa: a cross sectional study for development and validation.

PubMed

Mitchell, Marc; Hedt, Bethany L; Eshun-Wilson, Ingrid; Fraser, Hamish; John, Melanie-Anne; Menezes, Colin; Grobusch, Martin P; Jackson, Jonathan; Taljaard, Jantjie; Lesh, Neal

2012-03-01

The shortage of doctors and nurses, along with future expansion into rural clinics, will require that the majority of clinic visits by HIV infected patients on antiretroviral therapy (ART) are managed by non-doctors. The goal of this study was to develop and evaluate a screening protocol to determine which patients needed a full clinical assessment and which patients were stable enough to receive their medications without a doctor's consultation. For this study, we developed an electronic, handheld tool to guide non-physician counselors through screening questions. Patients visiting two ART clinics in South Africa for routine follow-up visits between March 2007 and April 2008 were included in our study. Each patient was screened by non-physician counselors using the handheld device and then received a full clinical assessment. Clinicians' report on whether full clinical assessment had been necessary was used as the gold standard for determining "required referral". Observations were randomly divided into two datasets--989 for developing a referral protocol and 200 for validating protocol performance. A third of patients had at least one physical complaint, and 16% had five or more physical complaints. 38% of patients required referral for full clinical assessment. We identify a subset of questions which are 87% sensitive and 47% specific for recommended patient referral. The final screening protocol is highly sensitive and could reduce burden on ART clinicians by 30%. The uptake and acceptance of the handheld tool to support implementation of the protocol was high. Further examination of the data reveals several important questions to include in future referral algorithms to improve sensitivity and specificity. Based on these results, we identify a refined algorithm to explore in future evaluations. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Baseline dental plaque activity, mutans streptococci culture, and future caries experience in children.

PubMed

Hallett, Kerrod B; O'Rourke, Peter K

2013-01-01

The purpose of this study was to evaluate a chairside caries risk assessment protocol utilizing a caries prediction instrument, adenosine triphosphate (ATP) activity in dental plaque, mutans streptococci (MS) culture, and routine dental examination in five- to 10-year-old children at two regional Australian schools with high caries experience. Clinical indicators for future caries were assessed at baseline examination using a standardized prediction instrument. Plaque ATP activity was measured directly in relative light units (RLU) using a bioluminescence meter, and MS culture data were recorded. Each child's dentition was examined clinically and radiographically, and caries experience was recorded using enamel white spot lesions and decayed, missing, and filled surfaces for primary and permanent teeth indices. Univariate one-way analysis of variance between selected clinical indicators, ATP activity, MS count at baseline, and future new caries activity was performed, and a generalized linear model for prediction of new caries activity at 24 months was constructed. Future new caries activity was significantly associated with the presence of visible cavitations, reduced saliva flow, and orthodontic appliances at baseline (R(2)=0.2, P<.001). Baseline plaque adenosine triphosphate activity and mutans streptococci counts were not significantly associated with caries activity at 24 months.

The cost-effectiveness of interventions in diabetes: a review of published economic evaluations in the UK setting, with an eye on the future.

PubMed

Tucker, Daniel M D; Palmer, Andrew J

2011-04-01

To synthesise key outcomes data from cost-effectiveness studies in diabetes, in the UK setting, and describe a narrative for the evidence-base, in order to understand the direction that future health economics research in this field could be heading. The peer-reviewed literature was searched at http://www.pubmed.com for health economics analyses in diabetes in the UK setting published between 1995 and 2008, using the keywords: "costs", "cost-effectiveness", "diabetes", "UK". Studies on screening for diabetes or prevention of diabetes were excluded, along with studies that looked purely at cost of diabetes treatment or monitoring. There were over 350 hits on MEDLINE. A total of 23 articles were identified and reviewed. 18 studies were in type 2, two in type 1 and three studies in both types 1 and type 2 diabetes. All studies evaluated treatment from the perspective of the NHS, with the time horizons varying from 12 months to patient lifetimes. 13 studies estimated quality-adjusted life expectancy (QALE). The majority of studies used health economics modelling techniques to project clinical benefit and cost outcomes beyond the context of clinical trials, with Markov-type models predominating. The United Kingdom Prospective Study of Diabetes was the most frequently cited source of clinical effectiveness and cost data. Most studies were funded by the pharmaceutical industry and evaluated more expensive products, rather than cheaper generic therapies such as human insulin and metformin monotherapy. Treatment-to-target in patients with diabetes in the UK is generally cost-effective and sometimes cost-saving vs. standard care. Ongoing health economics analysis in diabetes is essential as new clinical data are published. Future analysis of clinical and cost outcomes in diabetes could be expected to look beyond the impact of interventions on HbA1c in isolation, as manufacturers seek to differentiate innovative products in the market. Furthermore, it is anticipated that the competitiveness in the market for interventions in diabetes will lead to future cost-effectiveness analysis taking more interest in comparisons of off-patent medication and generic, fixed-dose combination therapies. Copyright © 2010 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Towards an operational definition of pharmacy clinical competency

NASA Astrophysics Data System (ADS)

Douglas, Charles Allen

The scope of pharmacy practice and the training of future pharmacists have undergone a strategic shift over the last few decades. The pharmacy profession recognizes greater pharmacist involvement in patient care activities. Towards this strategic objective, pharmacy schools are training future pharmacists to meet these new clinical demands. Pharmacy students have clerkships called Advanced Pharmacy Practice Experiences (APPEs), and these clerkships account for 30% of the professional curriculum. APPEs provide the only opportunity for students to refine clinical skills under the guidance of an experienced pharmacist. Nationwide, schools of pharmacy need to evaluate whether students have successfully completed APPEs and are ready treat patients. Schools are left to their own devices to develop assessment programs that demonstrate to the public and regulatory agencies, students are clinically competent prior to graduation. There is no widely accepted method to evaluate whether these assessment programs actually discriminate between the competent and non-competent students. The central purpose of this study is to demonstrate a rigorous method to evaluate the validity and reliability of APPE assessment programs. The method introduced in this study is applicable to a wide variety of assessment programs. To illustrate this method, the study evaluated new performance criteria with a novel rating scale. The study had two main phases. In the first phase, a Delphi panel was created to bring together expert opinions. Pharmacy schools nominated exceptional preceptors to join a Delphi panel. Delphi is a method to achieve agreement of complex issues among experts. The principal researcher recruited preceptors representing a variety of practice settings and geographical regions. The Delphi panel evaluated and refined the new performance criteria. In the second phase, the study produced a novel set of video vignettes that portrayed student performances based on recommendations of an expert panel. Pharmacy preceptors assessed the performances with the new performance criteria. Estimates of reliability and accuracy from preceptors' assessments can be used to establish benchmarks for future comparisons. Findings from the first phase suggested preceptors held a unique perspective, where APPE assessments are based in relevance to clinical activities. The second phase analyzed assessment results from pharmacy preceptors who watched the video simulations. Reliability results were higher for non-randomized compared to randomized video simulations. Accuracy results showed preceptors more readily identified high and low student performances compared to average students. These results indicated the need for pharmacy preceptor training in performance assessment. The study illustrated a rigorous method to evaluate the validity and reliability of APPE assessment instruments.

The role of objective personality inventories in suicide risk assessment: an evaluation and proposal.

PubMed

Johnson, W B; Lall, R; Bongar, B; Nordlund, M D

1999-01-01

Objective personality assessment instruments offer a comparatively underutilized source of clinical data in attempts to evaluate and predict risk for suicide. In contrast to focal suicide risk measures, global personality inventories may be useful in identification of long-standing styles that predispose persons to eventual suicidal behavior. This article reviews the empirical literature regarding the efficacy of established personality inventories in predicting suicidality. The authors offer several recommendations for future research with these measures and conclude that such objective personality instruments offer only marginal utility as sources of clinical information in comprehensive suicide risk evaluations. Personality inventories may offer greatest utility in long-term assessment of suicide risk.

New clinical practice guidelines on the classification, evaluation and management of childhood interstitial lung disease in infants: what do they mean?

PubMed

Wambach, Jennifer A; Young, Lisa R

2014-12-01

The American Thoracic Society (ATS) recently published a clinical practice guideline regarding the classification, evaluation, and management of childhood interstitial lung disease in infancy (chILD). As disease entities among infants with ILD are often distinct from forms seen in older children and adults, the guideline encourages an age-based classification system and focuses on the diagnostic approach to neonates and infants <2 years of age. The guideline reviews current evidence and recommendations for the evaluation, relevant genetic studies, and management of symptomatic infants. Here, we summarize the ATS guideline, highlight the major concepts, and discuss future strategies aimed at addressing current gaps in knowledge.

Functional assessment and performance evaluation for assistive robotic manipulators: Literature review.

PubMed

Chung, Cheng-Shiu; Wang, Hongwu; Cooper, Rory A

2013-07-01

The user interface development of assistive robotic manipulators can be traced back to the 1960s. Studies include kinematic designs, cost-efficiency, user experience involvements, and performance evaluation. This paper is to review studies conducted with clinical trials using activities of daily living (ADLs) tasks to evaluate performance categorized using the International Classification of Functioning, Disability, and Health (ICF) frameworks, in order to give the scope of current research and provide suggestions for future studies. We conducted a literature search of assistive robotic manipulators from 1970 to 2012 in PubMed, Google Scholar, and University of Pittsburgh Library System - PITTCat. Twenty relevant studies were identified. Studies were separated into two broad categories: user task preferences and user-interface performance measurements of commercialized and developing assistive robotic manipulators. The outcome measures and ICF codes associated with the performance evaluations are reported. Suggestions for the future studies include (1) standardized ADL tasks for the quantitative and qualitative evaluation of task efficiency and performance to build comparable measures between research groups, (2) studies relevant to the tasks from user priority lists and ICF codes, and (3) appropriate clinical functional assessment tests with consideration of constraints in assistive robotic manipulator user interfaces. In addition, these outcome measures will help physicians and therapists build standardized tools while prescribing and assessing assistive robotic manipulators.

Healthcare students' experiences of an interprofessional, student-led neuro-rehabilitation community-based clinic.

PubMed

Gustafsson, Louise; Hutchinson, Laura; Theodoros, Deborah; Williams, Katrina; Copley, Anna; Fagan, Amy; Desha, Laura

2016-01-01

Student-led clinics are becoming more prominent as educators seek alternate models of clinical education for health professionals. The purpose of this study was to evaluate healthcare students' experiences of an interprofessional student-led clinic for clients with neurological conditions. Thirteen students representing occupational therapy, physiotherapy, and speech pathology were recruited for the study. A sequential mixed-methods evaluation was employed and the results from the Interprofessional Education Scale and focus group revealed that the students experienced positive perceptions of working collaboratively with other professions, forming good relationships with others, as well as an increased respect for the roles of other professions. The findings suggest that providing a capstone opportunity, where students can work as part of an interprofessional team with a real client, in a format they may come across in future clinical practice, may be beneficial in providing them with essential interprofessional skills as new graduate health professionals.

The Translational Science Benefits Model: A New Framework for Assessing the Health and Societal Benefits of Clinical and Translational Sciences

PubMed Central

Sarli, Cathy C.; Suiter, Amy M.; Carothers, Bobbi J.; Combs, Todd B.; Allen, Jae L.; Beers, Courtney E.; Evanoff, Bradley A.

2017-01-01

Abstract We report the development of the Translational Science Benefits Model (TSBM), a framework designed to support institutional assessment of clinical and translational research outcomes to measure clinical and community health impacts beyond bibliometric measures. The TSBM includes 30 specific and potentially measurable indicators that reflect benefits that accrue from clinical and translational science research such as products, system characteristics, or activities. Development of the TSBM was based on literature review, a modified Delphi method, and in‐house expert panel feedback. Three case studies illustrate the feasibility and face validity of the TSBM for identification of clinical and community health impacts that result from translational science activities. Future plans for the TSBM include further pilot testing and a resource library that will be freely available for evaluators, translational scientists, and academic institutions who wish to implement the TSBM framework in their own evaluation efforts. PMID:28887873

Using ballistocardiography to measure cardiac performance: a brief review of its history and future significance.

PubMed

Vogt, Emelie; MacQuarrie, David; Neary, John Patrick

2012-11-01

Ballistocardiography (BCG) is a non-invasive technology that has been used to record ultra-low-frequency vibrations of the heart allowing for the measurement of cardiac cycle events including timing and amplitudes of contraction. Recent developments in BCG have made this technology simple to use, as well as time- and cost-efficient in comparison with other more complicated and invasive techniques used to evaluate cardiac performance. Recent technological advances are considerably greater since the advent of microprocessors and laptop computers. Along with the history of BCG, this paper reviews the present and future potential benefits of using BCG to measure cardiac cycle events and its application to clinical and applied research. © 2012 The Authors Clinical Physiology and Functional Imaging © 2012 Scandinavian Society of Clinical Physiology and Nuclear Medicine.

Judging Surgical Research: How Should We Evaluate Performance and Measure Value?

PubMed Central

Souba, Wiley W.; Wilmore, Douglas W.

2000-01-01

Objective To establish criteria to evaluate performance in surgical research, and to suggest strategies to optimize research in the future. Summary Background Data Research is an integral component of the academic mission, focusing on important clinical problems, accounting for surgical advances, and providing training and mentoring for young surgeons. With constraints on healthcare resources, there is increasing pressure to generate clinical revenues at the expense of the time and effort devoted to surgical research. An approach that would assess the value of research would allow prioritization of projects. Further, alignment of high-priority research projects with clinical goals would optimize research gains and maximize the clinical enterprise. Methods The authors reviewed performance criteria applied to industrial research and modified these criteria to apply to surgical research. They reviewed several programs that align research objectives with clinical goals. Results Performance criteria were categorized along several dimensions: internal measures (quality, productivity, innovation, learning, and development), customer satisfaction, market share, and financial indices (cost and profitability). A “report card” was proposed to allow the assessment of research in an individual department or division. Conclusions The department’s business strategy can no longer be divorced from its research strategy. Alignment between research and clinical goals will maximize the department’s objectives but will create the need to modify existing hierarchical structures and reward systems. Such alignment appears to be the best way to ensure the success of surgical research in the future. PMID:10862192

Clinical Practice Guidelines for Delirium Management: Potential Application in Palliative Care

PubMed Central

Bush, Shirley H.; Bruera, Eduardo; Lawlor, Peter G.; Kanji, Salmaan; Davis, Daniel H.J.; Agar, Meera; Wright, David; Hartwick, Michael; Currow, David C.; Gagnon, Bruno; Simon, Jessica; Pereira, José L.

2014-01-01

Context Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. Objectives This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. Methods We searched PubMed (1990–2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. Results There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from “expert opinion” for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Conclusion Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. PMID:24766743

Boosting Quality Registries with Clinical Decision Support Functionality*. User Acceptance of a Prototype Applied to HIV/TB Drug Therapy.

PubMed

Wannheden, Carolina; Hvitfeldt-Forsberg, Helena; Eftimovska, Elena; Westling, Katarina; Ellenius, Johan

2017-08-11

The care of HIV-related tuberculosis (HIV/TB) is complex and challenging. Clinical decision support (CDS) systems can contribute to improve quality of care, but more knowledge is needed on factors determining user acceptance of CDS. To analyze physicians' and nurses' acceptance of a CDS prototype for evidence-based drug therapy recommendations for HIV/TB treatment. Physicians and nurses were involved in designing a CDS prototype intended for future integration with the Swedish national HIV quality registry. Focus group evaluation was performed with ten nurses and four physicians, respectively. The Unified Theory of Acceptance and Use of Technology (UTAUT) was used to analyze acceptance. We identified several potential benefits with the CDS prototype as well as some concerns that could be addressed by redesign. There was also concern about dependence on physician attitudes, as well as technical, organizational, and legal issues. Acceptance evaluation at a prototype stage provided rich data to improve the future design of a CDS prototype. Apart from design and development efforts, substantial organizational efforts are needed to enable the implementation and maintenance of a future CDS system.

Enhancing diversity in the public health research workforce: the research and mentorship program for future HIV vaccine scientists.

PubMed

Sopher, Carrie J; Adamson, Blythe Jane S; Andrasik, Michele P; Flood, Danna M; Wakefield, Steven F; Stoff, David M; Cook, Ryan S; Kublin, James G; Fuchs, Jonathan D

2015-04-01

We developed and evaluated a novel National Institutes of Health-sponsored Research and Mentorship Program for African American and Hispanic medical students embedded within the international, multisite HIV Vaccine Trials Network, and explored its impact on scientific knowledge, acquired skills, and future career plans. Scholars conducted social, behavioral, clinical, or laboratory-based research projects with HIV Vaccine Trials Network investigators over 8 to 16 weeks (track 1) or 9 to 12 months (track 2). We conducted an in-depth, mixed-methods evaluation of the first 2 cohorts (2011-2013) to identify program strengths, areas for improvement, and influence on professional development. A pre-post program assessment demonstrated increases in self-reported knowledge, professional skills, and interest in future HIV vaccine research. During in-depth interviews, scholars reported that a supportive, centrally administered program; available funding; and highly involved mentors and staff were keys to the program's early success. A multicomponent, mentored research experience that engages medical students from underrepresented communities and is organized within a clinical trials network may expand the pool of diverse public health scientists. Efforts to sustain scholar interest over time and track career trajectories are warranted.

Clinical leadership for high-quality care: developing future ward leaders.

PubMed

Enterkin, Judith; Robb, Elizabeth; McLaren, Susan

2013-03-01

This paper reports upon the development, delivery and evaluation of a leadership programme for aspiring Ward Leaders in one National Health Service Trust in England. The ward sister role is fundamental to quality patient care and clinical leadership, however the role is increasingly difficult to recruit to. A lack of formal preparation and skills development for the role has been widely acknowledged. An evaluation of a programme of education for leadership. Three cohorts (n = 60) completed the programme. Semi-structured questionnaires were completed by participants (n = 36: 60%) at the conclusion of the programme. Qualitative data from questionnaires was analysed using a thematic approach. Participants reported increased political, organizational and self-awareness, increased confidence, feelings of empowerment and the ability to empower others. Opportunities for networking with peers were valued within the action learning approach. For some participants, career intentions were clarified through reflection. The majority of participants had benefited from the leadership programme and valued this development as an empowering preparation for future careers. Investment in leadership preparation for future ward sister roles is strongly recommended as part of a strategy designed to enhance quality improvement, career path development, workforce empowerment and retention. © 2012 Blackwell Publishing Ltd.

Clinical governance in pre-hospital care.

PubMed Central

Robertson-Steel, I; Edwards, S; Gough, M

2001-01-01

This article seeks to discover and recognize the importance of clinical governance within a new and emerging quality National Health Service (NHS) system. It evaluates the present state of prehospital care and recommends how change, via clinical governance, can ensure a paradigm shift from its currently fragmented state to a seamless ongoing patient care episode. Furthermore, it identifies the drivers of a quality revolution, examines the monitoring and supervision of quality care, and evaluates the role of evidence-based practice. A frank and open view of immediate care doctors is presented, with recommendations to improve the quality of skill delivery and reduce the disparity that exists. Finally, it reviews the current problems with pre-hospital care and projects a future course for quality and patient care excellence. PMID:11383428

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

PubMed

Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A; Martin, Michelle Y; Durant, Raegan W; Ford, Jean G

2014-04-01

Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

Cross-System Evaluation of Clinical Trial Search Engines

PubMed Central

Jiang, Silis Y.; Weng, Chunhua

2014-01-01

Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities. PMID:25954590

Cross-system evaluation of clinical trial search engines.

PubMed

Jiang, Silis Y; Weng, Chunhua

2014-01-01

Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

[Effects of practical training to increase motivation for learning and related factors].

PubMed

Yamaguchi, Takumi; Akiyama, Shinji; Sagara, Hidenori; Tanaka, Akihiro; Miyauchi, Yoshirou; Araki, Hiroaki; Shibata, Kazuhiko; Izushi, Fumio; Namba, Hiroyuki

2014-01-01

Under the six-year pharmaceutical education system that was initiated in April 2006, students who had completed the course in March 2012 became the first graduates. The six-year system encourages students to develop a well-rounded personality, a deep sense of ethics, knowledge required for health care professionals, abilities to identify and solve problems, and practical skills required in clinical settings, as well as basic knowledge and skills. Under the new education system based on the "pharmaceutical education model core curriculums" and "practical training model core curriculums", general pharmaceutical education is implemented in each college, and five-month practical training is conducted in clinical settings. Clinical tasks experienced by students for the first time are expected to significantly influence their motivation to learn and future prospects. In the present survey research, students who had completed practical training evaluated the training program, and correspondence and logistic regression analyses of the results were conducted to examine the future effects and influences of the training on the students. The results suggest that the students viewed the practical training program positively. In addition, clinical experience during the training sessions not only influenced their decisions on future careers, but also significantly increased their motivation to learn. Furthermore, their motivation for learning was increased most by the enthusiasm of pharmacists who advised them in clinical settings, rather than the training program itself. To improve pharmaceutical clinical learning, it is important to develop teaching and working environments for pharmacists in charge of advising students in clinical training.

Evaluation of the end user (dentist) experience of undertaking clinical audit in the post April 2001 general dental services (GDS) scheme.

PubMed

Cannell, P J

2012-09-01

A mandatory scheme for clinical audit in the general dental services (GDS) was launched in April 2001. No evaluation of this mandatory scheme exists in the literature. This study provides an evaluation of this scheme. More recently a new dental contract was introduced in the general dental services (GDS) in April 2006. Responsibility for clinical audit activities was devolved to primary care trusts (PCTs) as part of their clinical governance remit. All GDPs within Essex were contacted by letter and invited to participate in the research. A qualitative research method was selected for this evaluation, utilising audio-taped semi-structured research interviews with eight general dental practitioners (GDPs) who had taken part in the GDS clinical audit scheme and who fitted the sampling criteria and strategy. The evaluation focused on dentists' experiences of the scheme. The main findings from the analysis of the GDS scheme data suggest that there is clear evidence of change following audit activities occurring within practices and for the benefit of patients. However, often it is the dentist only that undertakes a clinical audit project rather than the dental team, there is a lack of dissemination of project findings beyond the individual participating practices, very little useful feedback provided to participants who have completed a project and very limited use of formal re-auditing of a particular topic. This study provides evaluation of the GDS clinical audit scheme. Organisations who propose to undertake clinical audit activities in conjunction with dentistry in the future may benefit from incorporating and/or developing some findings from this evaluation into their project design and avoiding others.

Are privacy-enhancing technologies for genomic data ready for the clinic? A survey of medical experts of the Swiss HIV Cohort Study.

PubMed

Raisaro, Jean-Louis; McLaren, Paul J; Fellay, Jacques; Cavassini, Matthias; Klersy, Catherine; Hubaux, Jean-Pierre

2018-03-01

Protecting patient privacy is a major obstacle for the implementation of genomic-based medicine. Emerging privacy-enhancing technologies can become key enablers for managing sensitive genetic data. We studied physicians' attitude toward this kind of technology in order to derive insights that might foster their future adoption for clinical care. We conducted a questionnaire-based survey among 55 physicians of the Swiss HIV Cohort Study who tested the first implementation of a privacy-preserving model for delivering genomic test results. We evaluated their feedback on three different aspects of our model: clinical utility, ability to address privacy concerns and system usability. 38/55 (69%) physicians participated in the study. Two thirds of them acknowledged genetic privacy as a key aspect that needs to be protected to help building patient trust and deploy new-generation medical information systems. All of them successfully used the tool for evaluating their patients' pharmacogenomics risk and 90% were happy with the user experience and the efficiency of the tool. Only 8% of physicians were unsatisfied with the level of information and wanted to have access to the patient's actual DNA sequence. This survey, although limited in size, represents the first evaluation of privacy-preserving models for genomic-based medicine. It has allowed us to derive unique insights that will improve the design of these new systems in the future. In particular, we have observed that a clinical information system that uses homomorphic encryption to provide clinicians with risk information based on sensitive genetic test results can offer information that clinicians feel sufficient for their needs and appropriately respectful of patients' privacy. The ability of this kind of systems to ensure strong security and privacy guarantees and to provide some analytics on encrypted data has been assessed as a key enabler for the management of sensitive medical information in the near future. Providing clinically relevant information to physicians while protecting patients' privacy in order to comply with regulations is crucial for the widespread use of these new technologies. Copyright © 2017. Published by Elsevier Inc.

A framework for evaluating the appropriateness of clinical decision support alerts and responses

PubMed Central

Waitman, Lemuel R; Lewis, Julia B; Wright, Julie A; Choma, David P; Miller, Randolph A; Peterson, Josh F

2011-01-01

Objective Alerting systems, a type of clinical decision support, are increasingly prevalent in healthcare, yet few studies have concurrently measured the appropriateness of alerts with provider responses to alerts. Recent reports of suboptimal alert system design and implementation highlight the need for better evaluation to inform future designs. The authors present a comprehensive framework for evaluating the clinical appropriateness of synchronous, interruptive medication safety alerts. Methods Through literature review and iterative testing, metrics were developed that describe successes, justifiable overrides, provider non-adherence, and unintended adverse consequences of clinical decision support alerts. The framework was validated by applying it to a medication alerting system for patients with acute kidney injury (AKI). Results Through expert review, the framework assesses each alert episode for appropriateness of the alert display and the necessity and urgency of a clinical response. Primary outcomes of the framework include the false positive alert rate, alert override rate, provider non-adherence rate, and rate of provider response appropriateness. Application of the framework to evaluate an existing AKI medication alerting system provided a more complete understanding of the process outcomes measured in the AKI medication alerting system. The authors confirmed that previous alerts and provider responses were most often appropriate. Conclusion The new evaluation model offers a potentially effective method for assessing the clinical appropriateness of synchronous interruptive medication alerts prior to evaluating patient outcomes in a comparative trial. More work can determine the generalizability of the framework for use in other settings and other alert types. PMID:21849334

Medical Ethics Education: Coming of Age.

ERIC Educational Resources Information Center

Miles, Steven H.; And Others

1989-01-01

A discussion of medical ethics in the medical curriculum reviews its recent history, examines areas of consensus, and describes teaching objectives and methods, course content, and program evaluation at preclinical and clinical levels. Prerequisites for successful institutionalization of medical ethics education are defined, and its future is…

Targeting oncogenic vulnerabilities in triple negative breast cancer: biological bases and ongoing clinical studies

PubMed Central

Ocana, Alberto; Pandiella, Atanasio

2017-01-01

Triple negative breast cancer (TNBC) is still an incurable disease despite the great scientific effort performed during the last years. The huge heterogeneity of this disease has motivated the evaluation of a great number of therapies against different molecular alterations. In this article, we review the biological bases of this entity and how the known molecular evidence supports the current preclinical and clinical development of new therapies. Special attention will be given to ongoing clinical studies and potential options for future drug combinations. PMID:28108739

Case study of evaluations that go beyond clinical outcomes to assess quality improvement diabetes programmes using the Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE).

PubMed

Paquette-Warren, Jann; Harris, Stewart B; Naqshbandi Hayward, Mariam; Tompkins, Jordan W

2016-10-01

Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real-world evaluation. Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real-world comprehensive evaluations in health care settings. The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub-steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built-in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale-up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. © 2016 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

Testing the prospective evaluation of a new healthcare system

PubMed Central

Planitz, Birgit; Sanderson, Penelope; Freeman, Clinton; Xiao, Tania; Botea, Adi; Orihuela, Cristina Beltran

2012-01-01

Research into health ICT adoption suggests that the failure to understand the clinical workplace has been a major contributing factor to the failure of many computer-based clinical systems. We suggest that clinicians and administrators need methods for envisioning future use when adopting new ICT. This paper presents and evaluates a six-stage “prospective evaluation” model that clinicians can use when assessing the impact of a new electronic patient information system on a Specialist Outpatients Department (SOPD). The prospective evaluation model encompasses normative, descriptive, formative and projective approaches. We show that this combination helped health informaticians to make reasonably accurate predictions for technology adoption at the SOPD. We suggest some refinements, however, to improve the scope and accuracy of predictions. PMID:23304347

Pilot clinic study of Project EX for smoking cessation with Spanish adolescents.

PubMed

Espada, José P; Gonzálvez, María T; Orgilés, Mireia; Guillén-Riquelme, Alejandro; Soto, Daniel; Sussman, Steve

2015-06-01

Despite efforts to prevent smoking, the prevalence of smoking in Spanish adolescents remains high. So far, there are no evidence-based smoking cessation programs for adolescents in Spain. This study describes the evaluation of Project EX, an eight-session school-based clinic smoking cessation program, with Spanish cigarette smokers 13-19 years of age, from 9 schools (four program condition schools and five control condition schools). A group-randomized controlled trial was used. There were 211 smokers at baseline (112 program group, and 99 control group). Evaluation involved an immediate pretest and posttest survey (administered five-weeks later) and six-month follow-up (after the immediate posttest). At immediate posttest, Project EX significantly reduced future nicotine dependence scores (mFTQ; p<.001), and increased intention to quit smoking (p<.001), and led to a higher previous day (prior to assessment) quit rate (p<.03). At the six-month follow-up, the percentage of quitters in the program group was 14.28%, whereas no smokers quit smoking in the control group (p<.04), and Project EX had a significant influence on future smoking expectation (p=.006) and overall level of 30-day smoking. Results for the Project EX school-based clinic are promising for adolescent smokers in Spain, although difficulties in recruitment and high attrition are of concern. Findings and limitations are discussed and suggestions for future research are suggested. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of psychology practitioner competence in clinical supervision.

PubMed

Gonsalvez, Craig J; Crowe, Trevor P

2014-01-01

There is a growing consensus favouring the development, advancement, and implementation of a competency-based approach for psychology training and supervision. There is wide recognition that skills, attitude-values, and relationship competencies are as critical to a psychologist's competence as are knowledge capabilities, and that these key competencies are best measured during placements, leaving the clinical supervisor in an unparalleled position of advantage to provide formative and summative evaluations on the supervisee's progression towards competence. Paradoxically, a compelling body of literature from across disciplines indicates that supervisor ratings of broad domains of competence are systematically compromised by biases, including leniency error and halo effect. The current paper highlights key issues affecting summative competency evaluations by supervisors: what competencies should be evaluated, who should conduct the evaluation, how (tools) and when evaluations should be conducted, and process variables that affect evaluation. The article concludes by providing research recommendations to underpin and promote future progress and by offering practice recommendations to facilitate a more credible and meaningful evaluation of competence and competencies.

Evidence-based Medicine in Facial Plastic Surgery: Current State and Future Directions.

PubMed

Dedhia, Raj; Hsieh, Tsung-Yen; Tollefson, Travis T; Ishii, Lisa E

2016-08-01

Evidence-based medicine (EBM) encompasses the evaluation and application of best available evidence, incorporation of clinical experience, and emphasis on patient preference and values. Different scales are used to rate levels of evidence. Translating available data for interventions to clinical practice guidelines requires an assessment of both the quality of evidence and the strength of recommendation. Essential to the practice of EBM is evaluating the effectiveness of an intervention through outcome measures. This article discusses principles essential to EBM, resources commonly used in EBM practice, and the strengths and limitations of EBM in facial plastic and reconstructive surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

The clinical effectiveness and cost-effectiveness of testing for cytochrome P450 polymorphisms in patients with schizophrenia treated with antipsychotics: a systematic review and economic evaluation.

PubMed

Fleeman, N; McLeod, C; Bagust, A; Beale, S; Boland, A; Dundar, Y; Jorgensen, A; Payne, K; Pirmohamed, M; Pushpakom, S; Walley, T; de Warren-Penny, P; Dickson, R

2010-01-01

To determine whether testing for cytochrome P450 (CYP) polymorphisms in adults entering antipsychotic treatment for schizophrenia leads to improvement in outcomes, is useful in medical, personal or public health decision-making, and is a cost-effective use of health-care resources. The following electronic databases were searched for relevant published literature: Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, EMBASE, Health Technology Assessment database, ISI Web of Knowledge, MEDLINE, PsycINFO, NHS Economic Evaluation Database, Health Economic Evaluation Database, Cost-effectiveness Analysis (CEA) Registry and the Centre for Health Economics website. In addition, publicly available information on various genotyping tests was sought from the internet and advisory panel members. A systematic review of analytical validity, clinical validity and clinical utility of CYP testing was undertaken. Data were extracted into structured tables and narratively discussed, and meta-analysis was undertaken when possible. A review of economic evaluations of CYP testing in psychiatry and a review of economic models related to schizophrenia were also carried out. For analytical validity, 46 studies of a range of different genotyping tests for 11 different CYP polymorphisms (most commonly CYP2D6) were included. Sensitivity and specificity were high (99-100%). For clinical validity, 51 studies were found. In patients tested for CYP2D6, an association between genotype and tardive dyskinesia (including Abnormal Involuntary Movement Scale scores) was found. The only other significant finding linked the CYP2D6 genotype to parkinsonism. One small unpublished study met the inclusion criteria for clinical utility. One economic evaluation assessing the costs and benefits of CYP testing for prescribing antidepressants and 28 economic models of schizophrenia were identified; none was suitable for developing a model to examine the cost-effectiveness of CYP testing. Tests for determining genotypes appear to be accurate although not all aspects of analytical validity were reported. Given the absence of convincing evidence from clinical validity studies, the lack of clinical utility and economic studies, and the unsuitability of published schizophrenia models, no model was developed; instead key features and data requirements for economic modelling are presented. Recommendations for future research cover both aspects of research quality and data that will be required to inform the development of future economic models.

Development of biosimilars in an era of oncologic drug shortages

PubMed Central

Li, Edward; Subramanian, Janakiraman; Anderson, Scott; Thomas, Dolca; McKinley, Jason; Jacobs, Ira A

2015-01-01

Acute and chronic shortages of various pharmaceuticals and particularly of sterile injectable products are being reported on a global scale, prompting evaluation of more effective strategies to manage current shortages and development of new, high-quality pharmaceutical products to mitigate the risk of potential future shortages. Oncology drugs such as liposomal doxorubicin and 5-fluorouracil represent examples of first-choice drugs critically affected by shortages. Survey results indicate that the majority of hospitals and practicing oncologists have experienced drug shortages, which may have compromised patient safety and clinical outcomes, and increased health care costs, due to delays or changes in treatment regimens. Clinical trials evaluating novel agents in combination with standard-of-care drugs are also being affected by drug shortages. Clinical and ethical considerations on treatment objectives, drug indication, and availability of alternative options may help in prioritizing cancer patients involved in active drug shortages. The United States Food and Drug Administration and the European Medicines Agency have identified manufacturing problems, delays in supply, and lack of available active ingredients as the most frequent causes of recent or ongoing drug shortages, and have released specific guidance to monitor, manage, and reduce the risk of shortages. The upcoming loss of exclusivity for a number of anticancer biologics, together with the introduction of an abbreviated approval pathway for biosimilars, raises the question of whether these products will be vulnerable to shortages. Future supply by reliable manufacturers of well characterized biosimilar monoclonal antibodies, developed in compliance with regulatory and manufacturing guidelines and with substantial investments, may contribute to prevent future biologics shortages and ensure access to effective and safe treatment options for patients with cancer. Preclinical and clinical characterization is ongoing for potential biosimilars of trastuzumab, rituximab, and bevacizumab, with promising results. PMID:26150698

Teledermatology. Current status and future directions.

PubMed

Whited, J D

2001-01-01

Teledermatology is becoming an increasingly common means of delivering dermatologic healthcare worldwide and will almost certainly play a greater role in the future. The type of technology used distinguishes the 2 modes of teledermatology consultation. The store and forward technique uses still digital images generated by a digital camera. Consultations of this type are considered asynchronous since the images are obtained, sent, and reviewed at different times. In contrast, real-time interactive consultations are synchronous. Patients and clinicians interact in real-time through an audio-video communication link. Each modality has its advantages and disadvantages, and studies appear in the literature that assess both technologies. Although diagnostic reliability (precision) assessments for teledermatology are subject to limitations, existing information indicates that both store and forward and real-time interactive technology result in reliable diagnostic outcomes when compared with clinic-based evaluations. Less information regarding diagnostic accuracy is available; however, one evaluation that used store and forward technology found comparable diagnostic accuracy between teledermatology consultations and clinic-based examinations. Currently, little information is available regarding cost effectiveness and patient outcomes. Existing evidence, while inconclusive, suggests that teledermatology may be more costly than traditional clinic-based care, especially when using real-time interactive technology. Teledermatology has been shown to have utility as a triage mechanism for determining the urgency or need for a clinic-based consultation. Overall, patients appear to accept teledermatology and are satisfied with it as a means of obtaining healthcare. Clinicians have also generally reported positive experiences with teledermatology. Future studies that focus on cost effectiveness, patient outcomes, and patient and clinician satisfaction will help further define the potential of teledermatology as a means of dermatologic healthcare delivery.

Overview on Clinical Relevance of Intra-Tumor Heterogeneity.

PubMed

Stanta, Giorgio; Bonin, Serena

2018-01-01

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

Challenges of assessing the clinical efficacy of asexual blood-stage Plasmodium falciparum malaria vaccines.

PubMed

Sheehy, Susanne H; Douglas, Alexander D; Draper, Simon J

2013-09-01

In the absence of any highly effective vaccine candidate against Plasmodium falciparum malaria, it remains imperative for the field to pursue all avenues that may lead to the successful development of such a formulation. The development of a subunit vaccine targeting the asexual blood-stage of Plasmodium falciparum malaria infection has proven particularly challenging with only limited success to date in clinical trials. However, only a fraction of potential blood-stage vaccine antigens have been evaluated as targets, and a number of new promising candidate antigen formulations and delivery platforms are approaching clinical development. It is therefore essential that reliable and sensitive methods of detecting, or ruling out, even modest efficacy of blood-stage vaccines in small clinical trials be established. In this article we evaluate the challenges facing blood-stage vaccine developers, assess the appropriateness and limitations of various in vivo approaches for efficacy assessment and suggest future directions for the field.

Functional assessment and performance evaluation for assistive robotic manipulators: Literature review

PubMed Central

Chung, Cheng-Shiu; Wang, Hongwu; Cooper, Rory A.

2013-01-01

Context The user interface development of assistive robotic manipulators can be traced back to the 1960s. Studies include kinematic designs, cost-efficiency, user experience involvements, and performance evaluation. This paper is to review studies conducted with clinical trials using activities of daily living (ADLs) tasks to evaluate performance categorized using the International Classification of Functioning, Disability, and Health (ICF) frameworks, in order to give the scope of current research and provide suggestions for future studies. Methods We conducted a literature search of assistive robotic manipulators from 1970 to 2012 in PubMed, Google Scholar, and University of Pittsburgh Library System – PITTCat. Results Twenty relevant studies were identified. Conclusion Studies were separated into two broad categories: user task preferences and user-interface performance measurements of commercialized and developing assistive robotic manipulators. The outcome measures and ICF codes associated with the performance evaluations are reported. Suggestions for the future studies include (1) standardized ADL tasks for the quantitative and qualitative evaluation of task efficiency and performance to build comparable measures between research groups, (2) studies relevant to the tasks from user priority lists and ICF codes, and (3) appropriate clinical functional assessment tests with consideration of constraints in assistive robotic manipulator user interfaces. In addition, these outcome measures will help physicians and therapists build standardized tools while prescribing and assessing assistive robotic manipulators. PMID:23820143

A benchmark for comparison of dental radiography analysis algorithms.

PubMed

Wang, Ching-Wei; Huang, Cheng-Ta; Lee, Jia-Hong; Li, Chung-Hsing; Chang, Sheng-Wei; Siao, Ming-Jhih; Lai, Tat-Ming; Ibragimov, Bulat; Vrtovec, Tomaž; Ronneberger, Olaf; Fischer, Philipp; Cootes, Tim F; Lindner, Claudia

2016-07-01

Dental radiography plays an important role in clinical diagnosis, treatment and surgery. In recent years, efforts have been made on developing computerized dental X-ray image analysis systems for clinical usages. A novel framework for objective evaluation of automatic dental radiography analysis algorithms has been established under the auspices of the IEEE International Symposium on Biomedical Imaging 2015 Bitewing Radiography Caries Detection Challenge and Cephalometric X-ray Image Analysis Challenge. In this article, we present the datasets, methods and results of the challenge and lay down the principles for future uses of this benchmark. The main contributions of the challenge include the creation of the dental anatomy data repository of bitewing radiographs, the creation of the anatomical abnormality classification data repository of cephalometric radiographs, and the definition of objective quantitative evaluation for comparison and ranking of the algorithms. With this benchmark, seven automatic methods for analysing cephalometric X-ray image and two automatic methods for detecting bitewing radiography caries have been compared, and detailed quantitative evaluation results are presented in this paper. Based on the quantitative evaluation results, we believe automatic dental radiography analysis is still a challenging and unsolved problem. The datasets and the evaluation software will be made available to the research community, further encouraging future developments in this field. (http://www-o.ntust.edu.tw/~cweiwang/ISBI2015/). Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Clinical practice guidelines for delirium management: potential application in palliative care.

PubMed

Bush, Shirley H; Bruera, Eduardo; Lawlor, Peter G; Kanji, Salmaan; Davis, Daniel H J; Agar, Meera; Wright, David Kenneth; Hartwick, Michael; Currow, David C; Gagnon, Bruno; Simon, Jessica; Pereira, José L

2014-08-01

Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. We searched PubMed (1990-2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from "expert opinion" for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Satisfaction with Healthcare Received at an Interprofessional Student-run Free Clinic: Invested in Training the Next Generation of Healthcare Professionals.

PubMed

Lu, Karen B; Thiel, Bryan; Atkins, Christopher A; Desai, Anand; Botwin, Ariel; Povlow, Michael R; Simms-Cendan, Judith; Pasarica, Magdalena

2018-03-07

Most medical schools in the United States have an associated student-run free clinic (SRFC) providing medical care to the underserved population around the campus. SRFCs provide students with opportunities to practice history-taking and diagnosis skills. There have been a few studies that have evaluated patient satisfaction within SRFCs; however, these studies report limited aspects of care within these clinics. This study hopes to determine the levels of satisfaction with clinical staff and operations and to ensure that the medical needs of patients are being met. Results showed that 91% of the patients were satisfied or very satisfied with their overall clinic experience. The highest scoring parameters were "courtesy/respect of staff", "availability of free or affordable medications", and "doctor's knowledge". Overall, the patients are satisfied with the staff, care, and availability of medicine provided by the Keeping Neighbors in Good Health Through Service (KNIGHTS) clinic. Most patients enjoy participating in the training and education of future physicians and would recommend this clinic to a friend or family member. The lowest satisfaction rates were associated with length of visit and wait time. In the future, SRFCs should work together to assess patient satisfaction in the clinics, identify problem areas, and develop generalizable interventions for improvement.

Agreement among orthodontists experienced with cone-beam computed tomography on the need for follow-up and the clinical impact of craniofacial findings from multiplanar and 3-dimensional reconstructed views.

PubMed

Edwards, Ryan; Alsufyani, Noura; Heo, Giseon; Flores-Mir, Carlos

2015-08-01

In this study, we aimed to assess interrater and intrarater agreement among orthodontic clinicians in their assessments of reported incidental findings in regard to both the need for additional follow-up and the impact on future orthodontic treatment in large-field maxillofacial cone-beam computed tomography (CBCT) imaging. The study sample consisted of 18 nonrandomly selected large-field maxillofacial CBCT volumes containing a reported total of 88 radiographic findings. All scans were associated with formal radiologic reports. However, the suggestions of further follow-up were removed from the radiologic reports so as to not bias the 3 evaluating orthodontists in their subsequent decision making. The evaluators had on average 7.6 years of CBCT usage and self-interpretation experience. Reliability was determined by quantifying the level of agreement between the evaluators' assessments for both research questions for all 88 findings using a binary response (yes/no) as the outcome measure. The Cohen kappa statistic was calculated to quantify intrarater and interrater agreement globally for both statements. Although interrater agreement was considerable, potential decisions with clinical impact were not consistent. This needs to be considered when interpreting maxillofacial incidental findings. Evaluators demonstrated higher levels of agreement for dentoalveolar findings compared with all other extragnathic regions when assessing clinical significance. Among the evaluators who were considered experienced in CBCT, "fair-to-good" interrater agreement and "excellent" intrarater agreement were demonstrated in terms of the need for further follow-up and their potential impact on future orthodontic treatment. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

PubMed

Asano, K; Tanaka, A; Sato, T; Uyama, Y

2013-08-01

Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

Standardized Patients Provide Realistic and Worthwhile Experiences for Athletic Training Students

ERIC Educational Resources Information Center

Walker, Stacy E.; Weidner, Thomas G.

2010-01-01

Context: Standardized patients are more prominently used to both teach and evaluate students' clinical skills and abilities. Objective: To investigate whether athletic training students perceived an encounter with a standardized patient (SP) as realistic and worthwhile and to determine their perceived comfort in future lower extremity evaluations…

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

PubMed

Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

2009-08-01

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

Clinical case definition for the diagnosis of acute intussusception.

PubMed

Bines, Julie E; Ivanoff, Bernard; Justice, Frances; Mulholland, Kim

2004-11-01

Because of the reported association between intussusception and a rotavirus vaccine, future clinical trials of rotavirus vaccines will need to include intussusception surveillance in the evaluation of vaccine safety. The aim of this study is to develop and validate a clinical case definition for the diagnosis of acute intussusception. A clinical case definition for the diagnosis of acute intussusception was developed by analysis of an extensive literature review that defined the clinical presentation of intussusception in 70 developed and developing countries. The clinical case definition was then assessed for sensitivity and specificity using a retrospective chart review of hospital admissions. Sensitivity of the clinical case definition was assessed in children diagnosed with intussusception over a 6.5-year period. Specificity was assessed in patients aged <2 years admitted with bowel obstruction and in patients aged <19 years presenting with symptoms that may occur in intussusception. The clinical case definition accurately identified 185 of 191 assessable cases as "probable" intussusception and six cases as "possible" intussusception (sensitivity, 97%). No case of radiologic or surgically proven intussusception failed to be identified by the clinical case definition. The specificity of the definition in correctly identifying patients who did not have intussusception ranged from 87% to 91%. The clinical case definition for intussusception may assist in the prompt identification of patients with intussusception and may provide an important tool for the future trials of enteric vaccines.

Hologram stability evaluation for Microsoft HoloLens

NASA Astrophysics Data System (ADS)

Vassallo, Reid; Rankin, Adam; Chen, Elvis C. S.; Peters, Terry M.

2017-03-01

Augmented reality (AR) has an increasing presence in the world of image-guided interventions which is amplified by the availability of consumer-grade head-mounted display (HMD) technology. The Microsoft® HoloLensTM optical passthrough device is at the forefront of consumer technology, as it is the first un-tethered head mounted computer (HMC). It shows promise of effectiveness in guiding clinical interventions, however its accuracy and stability must still be evaluated for the clinical environment. We have developed an evaluative protocol for the HoloLensTM using an optical measurement device to digitize the perceived pose of the rendered hologram. This evaluates the ability of the HoloLensTM to maintain the hologram in its intended pose. The stability is measured when actions are performed that may cause a shift in the holograms' pose due to errors in its simultaneous localization and mapping. An emphasis is placed on actions that are more likely to be performed in a clinical setting. This will be used to determine the most applicable use cases for this technology in the future and how to minimize errors when in use. Our results show promise of this device's potential for intraoperative clinical use. Further analysis must be performed to evaluate other potential sources of hologram disruption.

Lessons learned from the Syrian sarin attack: evaluation of a clinical syndrome through social media.

PubMed

Rosman, Yossi; Eisenkraft, Arik; Milk, Nadav; Shiyovich, Arthur; Ophir, Nimrod; Shrot, Shai; Kreiss, Yitshak; Kassirer, Michael

2014-05-06

On the night of 21 August 2013, sarin was dispersed in the eastern outskirts of Damascus, killing 1400 civilians and severely affecting thousands more. This article aims to delineate the clinical presentation and management of a mass casualty event caused by a nerve agent as shown in the social media. Authors searched YouTube for videos uploaded of this attack and identified 210 videos. Of these, 67 met inclusion criteria and were evaluated in the final analysis.These videos displayed 130 casualties; 119 (91.5%) of which were defined as moderately injured or worse. The most common clinical signs were dyspnea (53.0%), diaphoresis (48.5%), and loss of consciousness (40.7%). Important findings included a severe shortage of supporting measures and lack of antidotal autoinjectors. Decontamination, documented in 25% of the videos, was done in an inefficient manner. Protective gear was not noticed, except for sporadic use of latex gloves and surgical masks.This is believed to be the first time that social media was used to evaluate clinical data and management protocols to better prepare against future possible events.

Evolution of an information literacy curriculum for third-year medical students.

PubMed

O'Dwyer, Linda; Kerns, Stephanie C

2011-01-01

Information literacy curriculum for third-year medical students at Northwestern University has evolved over several years under the guidance of librarians at the Galter Health Sciences Library. Starting as a series of rotation-specific information resource overviews, initial evaluation and feedback led to the curriculum being developed to include more focused and interactive clinical information sessions with a quiz-based assessment. Future enhancements will include web-based self-directed learning using online tutorials, additional search exercises that mimic the on-the-go clinical environment, and better assessment of the curriculum's impact on students' information literacy and clinical search skills.

Pediatric Cardiovascular Clinical Trials: An Analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database

PubMed Central

Hill, Kevin D.; Henderson, Heather T.; Hornik, Christoph P.; Li, Jennifer S.

2015-01-01

Recent regulatory initiatives in the United States and Europe have transformed the pediatric clinical trials landscape by significantly increasing capital investment and pediatric trial volume. The purpose of this manuscript is to review the impact of these initiatives on the pediatric cardiovascular trials landscape when compared to other pediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major pediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field. PMID:26377725

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.

PubMed

Hill, Kevin D; Henderson, Heather T; Hornik, Christoph P; Li, Jennifer S

2015-08-01

Recent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.

Healthcare students' evaluation of the clinical learning environment and supervision - a cross-sectional study.

PubMed

Pitkänen, Salla; Kääriäinen, Maria; Oikarainen, Ashlee; Tuomikoski, Anna-Maria; Elo, Satu; Ruotsalainen, Heidi; Saarikoski, Mikko; Kärsämänoja, Taina; Mikkonen, Kristina

2018-03-01

The purpose of clinical placements and supervision is to promote the development of healthcare students´ professional skills. High-quality clinical learning environments and supervision were shown to have significant influence on healthcare students´ professional development. This study aimed to describe healthcare students` evaluation of the clinical learning environment and supervision, and to identify the factors that affect these. The study was performed as a cross-sectional study. The data (n = 1973) were gathered through an online survey using the Clinical Learning Environment, Supervision and Nurse Teacher scale during the academic year 2015-2016 from all healthcare students (N = 2500) who completed their clinical placement at a certain university hospital in Finland. The data were analysed using descriptive statistics and binary logistic regression analysis. More than half of the healthcare students had a named supervisor and supervision was completed as planned. The students evaluated the clinical learning environment and supervision as 'good'. The students´ readiness to recommend the unit to other students and the frequency of separate private unscheduled sessions with the supervisor were the main factors that affect healthcare students` evaluation of the clinical learning environment and supervision. Individualized and goal-oriented supervision in which the student had a named supervisor and where supervision was completed as planned in a positive environment that supported learning had a significant impact on student's learning. The clinical learning environment and supervision support the development of future healthcare professionals' clinical competence. The supervisory relationship was shown to have a significant effect on the outcomes of students' experiences. We recommend the planning of educational programmes for supervisors of healthcare students for the enhancement of supervisors' pedagogical competencies in supervising students in the clinical practice. Copyright © 2018 Elsevier Ltd. All rights reserved.

Inhaled antibiotics in the treatment of non-cystic fibrosis bronchiectasis: clinical and drug delivery perspectives.

PubMed

Sugianto, Tiffanie Daisy; Chan, Hak-Kim

2016-01-01

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic, progressive, suppurative lung disease characterized by permanent dilatation of bronchial subdivisions, which further causes accumulation of sputum and bacterial infections. The advent of inhaled antibiotics over the past two decades has been expected to effectively attenuate the problem of chronic bacterial infections in CF and NCFB subjects with higher, local drug concentrations and minimal systemic side effects. This review summarizes and evaluates current clinical evidence of efficacy and adverse effects of inhaled antibiotics in NCFB, as well as ongoing preclinical and clinical studies, followed by a discussion of issues and challenges in clinical practice and drug delivery strategies, together with future research directions. The evidence base of the clinical efficacy of inhaled antibiotics in NCFB is limited and the degrees of reported clinical benefits have been modest and conflicting. Challenges surrounding inhaled antibiotics application and development include the lack of knowledge of disease factors and optimum management strategies, unreceptive lung pathophysiology and the lack of factors that support compliance and tolerability. Nonetheless, research continues to give birth to new clinical findings and novel formulations such as combination antibiotics and sustained-release formulations, which add great value to the development of efficacious, safe and convenient inhalable antibiotics of the future.

Development of the Computerized Model of Performance-Based Measurement System to Measure Nurses' Clinical Competence.

PubMed

Liou, Shwu-Ru; Liu, Hsiu-Chen; Tsai, Shu-Ling; Cheng, Ching-Yu; Yu, Wei-Chieh; Chu, Tsui-Ping

2016-04-01

Critical thinking skills and clinical competence are for providing quality patient care. The purpose of this study is to develop the Computerized Model of Performance-Based Measurement system based on the Clinical Reasoning Model. The system can evaluate and identify learning needs for clinical competency and be used as a learning tool to increase clinical competency by using computers. The system includes 10 high-risk, high-volume clinical case scenarios coupled with questions testing clinical reasoning, interpersonal, and technical skills. Questions were sequenced to reflect patients' changing condition and arranged by following the process of collecting and managing information, diagnosing and differentiating urgency of problems, and solving problems. The content validity and known-groups validity was established. The Kuder-Richardson Formula 20 was 0.90 and test-retest reliability was supported (r = 0.78). Nursing educators can use the system to understand students' needs for achieving clinical competence, and therefore, educational plans can be made to better prepare students and facilitate their smooth transition to a future clinical environment. Clinical nurses can use the system to evaluate their performance-based abilities and weakness in clinical reasoning. Appropriate training programs can be designed and implemented to practically promote nurses' clinical competence and quality of patient care.

Facilitating comparative effectiveness research in cancer genomics: evaluating stakeholder perceptions of the engagement process.

PubMed

Deverka, Patricia A; Lavallee, Danielle C; Desai, Priyanka J; Armstrong, Joanne; Gorman, Mark; Hole-Curry, Leah; O'Leary, James; Ruffner, B W; Watkins, John; Veenstra, David L; Baker, Laurence H; Unger, Joseph M; Ramsey, Scott D

2012-07-01

The Center for Comparative Effectiveness Research in Cancer Genomics completed a 2-year stakeholder-guided process for the prioritization of genomic tests for comparative effectiveness research studies. We sought to evaluate the effectiveness of engagement procedures in achieving project goals and to identify opportunities for future improvements. The evaluation included an online questionnaire, one-on-one telephone interviews and facilitated discussion. Responses to the online questionnaire were tabulated for descriptive purposes, while transcripts from key informant interviews were analyzed using a directed content analysis approach. A total of 11 out of 13 stakeholders completed both the online questionnaire and interview process, while nine participated in the facilitated discussion. Eighty-nine percent of questionnaire items received overall ratings of agree or strongly agree; 11% of responses were rated as neutral with the exception of a single rating of disagreement with an item regarding the clarity of how stakeholder input was incorporated into project decisions. Recommendations for future improvement included developing standard recruitment practices, role descriptions and processes for improved communication with clinical and comparative effectiveness research investigators. Evaluation of the stakeholder engagement process provided constructive feedback for future improvements and should be routinely conducted to ensure maximal effectiveness of stakeholder involvement.

[Myocardial viability: update in nuclear cardiology].

PubMed

Vallejo, Enrique

2007-01-01

Evaluation of myocardial viability with the aid of radionuclides, is a technique that offers reliable, reproducible information, with an attractive cost-benefit relationship, in the study of the myocardial viability, integrating cardiac molecular, metabolic, and functional aspects. Nowadays, coronary risk stratification in post-myocardial infarction patients pretends to locate them as low-, intermediate, and high risk-subjects that can suffer cardiovascular complications in the very near future. Low-risk patients are characterized by a cardiac-related mortality below 1%, whereas high-risk mortality is greater than 3%. Because of clinical complications following a myocardial infarction are observed during the first month of evolution, clinical guidelines suggest to evaluate the cardiovascular risk before hospital discharge.

Consolidative autologous hematopoietic stem-cell transplantation in first remission for non-Hodgkin lymphoma: current indications and future perspective.

PubMed

Iams, Wade; Reddy, Nishitha M

2014-10-01

The non-Hodgkin lymphomas (NHLs) are a heterogeneous group of diseases with variable clinical outcomes. Autologous hematopoietic stem-cell transplantation (ASCT) as frontline, consolidative therapy has been evaluated based upon histological subtype of NHL. In this review, we summarize the major clinical trials guiding the use of frontline ASCT in NHL. With the constantly changing landscape of upfront therapy and multiple promising novel agents, the ability to conduct randomized trials to evaluate the benefit of consolidative ASCT is not only challenging but may be considered by some an inept utilization of resources. Our recommendation for consolidative ASCT is based on analyzing the current available data.

Designing authentic assessment: strategies for nurse educators.

PubMed

Poindexter, Kathleen; Hagler, Debra; Lindell, Deborah

2015-01-01

Increased emphasis on health care safety requires renewed attention to teaching and learning processes for future health care professionals. When presented with problems situated in a clinical context, learners have rich opportunities to demonstrate integration of concepts. Authentic assessment is an approach to evaluation of learning through which students can demonstrate acquired knowledge, skills, and attitudes in the context of real-world or realistic nursing practice activities. This article describes features, approaches, and examples of authentic assessment processes in the context of classroom, clinical, and online nursing education.

Approaches to the Assessment of Children in the Context of Disasters.

PubMed

Lai, Betty S; Alisic, Eva; Lewis, Rayleen; Ronan, Kevin R

2016-05-01

Children exposed to disasters are a vulnerable population, making the assessment of children post-disaster an important issue. Utilizing a Multiple Gating Stepped Care framework, we highlight recent literature related to post-disaster assessment and intervention for children. In particular, we focus on screening, clinical evaluation, and feedback-informed service delivery. Screening allows large populations of children to be assessed at a relatively low cost. Children identified by screening as being at risk may then be assessed through more in-depth clinical evaluations, in order to assess clinical symptoms, strengths, and stressors, and to make determinations about appropriate interventions. Continued assessment during therapy provides important feedback for the delivery of appropriate care. New formats for assessment, as well as issues related to identifying sources for assessment, are discussed. Recommendations for future directions are provided.

Noninvasive ventilation.

PubMed

Rabatin, J T; Gay, P C

1999-08-01

Noninvasive ventilation refers to the delivery of assisted ventilatory support without the use of an endotracheal tube. Noninvasive positive pressure ventilation (NPPV) can be delivered by using a volume-controlled ventilator, a pressure-controlled ventilator, a bilevel positive airway pressure ventilator, or a continuous positive airway pressure device. During the past decade, there has been a resurgence in the use of noninvasive ventilation, fueled by advances in technology and clinical trials evaluating its use. Several manufacturers produce portable devices that are simple to operate. This review describes the equipment, techniques, and complications associated with NPPV and also the indications for both short-term and long-term applications. NPPV clearly represents an important addition to the techniques available to manage patients with respiratory failure. Future clinical trials evaluating its many clinical applications will help to define populations of patients most apt to benefit from this type of treatment.

Evaluation of LOINC for Representing Constitutional Cytogenetic Test Result Reports

PubMed Central

Heras, Yan Z.; Mitchell, Joyce A.; Williams, Marc S.; Brothman, Arthur R.; Huff, Stanley M.

2009-01-01

Genetic testing is becoming increasingly important to medical practice. Integrating genetics and genomics data into electronic medical records is crucial in translating genetic discoveries into improved patient care. Information technology, especially Clinical Decision Support Systems, holds great potential to help clinical professionals take full advantage of genomic advances in their daily medical practice. However, issues relating to standard terminology and information models for exchanging genetic testing results remain relatively unexplored. This study evaluates whether the current LOINC standard is adequate to represent constitutional cytogenetic test result reports using sample result reports from ARUP Laboratories. The results demonstrate that current standard terminology is insufficient to support the needs of coding cytogenetic test results. The terminology infrastructure must be developed before clinical information systems will be able to handle the high volumes of genetic data expected in the near future. PMID:20351857

Evaluation of LOINC for representing constitutional cytogenetic test result reports.

PubMed

Heras, Yan Z; Mitchell, Joyce A; Williams, Marc S; Brothman, Arthur R; Huff, Stanley M

2009-11-14

Genetic testing is becoming increasingly important to medical practice. Integrating genetics and genomics data into electronic medical records is crucial in translating genetic discoveries into improved patient care. Information technology, especially Clinical Decision Support Systems, holds great potential to help clinical professionals take full advantage of genomic advances in their daily medical practice. However, issues relating to standard terminology and information models for exchanging genetic testing results remain relatively unexplored. This study evaluates whether the current LOINC standard is adequate to represent constitutional cytogenetic test result reports using sample result reports from ARUP Laboratories. The results demonstrate that current standard terminology is insufficient to support the needs of coding cytogenetic test results. The terminology infrastructure must be developed before clinical information systems will be able to handle the high volumes of genetic data expected in the near future.

The STENTYS self-apposing stent technology in coronary artery disease: literature review and future directions.

PubMed

Lu, Huangling; de Winter, Robbert J; Koch, Karel T

2018-06-21

Coronary stent designs have been through extensive developments in the past few decades. Since the first introduction of the self-apposing STENTYS stent, several theoretical advantages of its nitinol platform have been clinically evaluated. This paper reviews the current status, ongoing work and future directions of this device. Areas covered: The OPEN (STENTYS Coronary Bifurcation Stent System fOr the PErcutaNeous treatment of de novo lesions in native bifurcated coronary arteries) trials revealed high technical success rates of the STENTYS performance in bifurcation lesions. The APPOSITION (Assessment of the Safety and Performance of the STENTYS self-expanding Coronary Stent in Acute Myocardial Infarction) trials demonstrated the safety and feasibility of the device in patients with acute myocardial infarction. Optical coherence tomography showed better short-term strut apposition in patients treated with the STENTYS stent in APPOSITION IV. The clinical outcomes of the device in saphenous vein graft lesions and left main coronary artery disease are favourable. Expert Commentary: Despite numerous theoretical advantages of the nitinol platform, superiority of the STENTYS self-apposing stent over currently available DES has not yet been proven. However, the ongoing registries evaluating the performance of the STENTYS Xposition will provide more insights in its clinical performance.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

RE-AIM in Clinical, Community, and Corporate Settings: Perspectives, Strategies, and Recommendations to Enhance Public Health Impact

PubMed Central

Harden, Samantha M.; Smith, Matthew Lee; Ory, Marcia G.; Smith-Ray, Renae L.; Estabrooks, Paul A.; Glasgow, Russell E.

2018-01-01

The RE-AIM Framework is a planning and evaluation model that has been used in a variety of settings to address various programmatic, environmental, and policy innovations for improving population health. In addition to the broad application and diverse use of the framework, there are lessons learned and recommendations for the future use of the framework across clinical, community, and corporate settings. The purposes of this article are to: (A) provide a brief overview of the RE-AIM Framework and its pragmatic use for planning and evaluation; (B) offer recommendations to facilitate the application of RE-AIM in clinical, community, and corporate settings; and (C) share perspectives and lessons learned about employing RE-AIM dimensions in the planning, implementation, and evaluation phases within these different settings. In this article, we demonstrate how the RE-AIM concepts and elements within each dimension can be applied by researchers and practitioners in diverse settings, among diverse populations and for diverse health topics. PMID:29623270

Thinking strategies of baccalaureate nursing students prompted by self-regulated learning strategies.

PubMed

Kuiper, RuthAnne; Murdock, Nancy; Grant, Nancy

2010-08-01

The standard in nursing education today is to prepare nurses for future practice through generic programs with a culminating practicum experience. The clinical faculty in this program was interested in evaluating differences in student thinking strategies that occurred as a result of an increase from 60 to 120 clinical hours, coupled with reflective journaling. The Self-Regulated Learning model was used as a conceptual support for the journaling prompts, as well as a structure for narrative analysis. the 120-hour practicum group revealed a greater use of metacognitive self-evaluation strategies versus greater use of behavioral self-monitoring strategies by the 60-hour practicum group. This finding suggests that although self-observation and self-monitoring are important and desired thinking habits to develop in nursing students, an increase to 120 hours is beneficial. It promotes a greater use of self-evaluation of thinking and greater levels of self-efficacy in making decisions to solve clinical problems.

The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

PubMed

Borgerson, Dawn; Dino, Jennifer

2012-01-01

Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

Food allergy: opportunities and challenges in the clinical practice of allergy and immunology.

PubMed

James, John M

2004-10-01

Food allergy offers numerous opportunities and challenges for the allergy and clinical immunology specialist. Physicians with board certification in allergy and clinical immunology should be the main source of reliable clinical information to educate patients with food-related disorders. There has been a wealth of reliable information published related to food allergy that can be utilized by health care providers in clinical practice. This includes information about the cross-reactivity of food allergens, the evaluation of potential new therapies, and the practical application of new diagnostic methods and management strategies. This article addresses some of the new developments in food allergy, with an emphasis on cross-reactvity of food allergens, recombinant food allergens, and potential future therapies for food allergy.

Current and future initiatives for vascular health management in clinical practice

PubMed Central

Cameron, James D; Asmar, Roland; Struijker-Boudier, Harry; Shirai, Kohji; Sirenko, Yuriy; Kotovskaya, Yulia; Topouchian, Jirar

2013-01-01

Central arterial structure and function comprise a primary determinant of vascular health, and are integral to the important concept of ventriculo-vascular coupling or interaction. Central aortic stiffening is a major influence on central blood pressure, and directly relates to coronary perfusion. The joint session of the International Society of Vascular Health (Eastern Region) and the Ukrainian Congress of Cardiology was held in Kiev, Ukraine, on September 23, 2011; it provided an expert forum to discuss arterial evaluations, clinical applications, and progress toward translating arterial protection into cardiovascular benefits. The conclusions of the expert panel were: Aortic stiffness is not presently a treatment target but may be useful for substratifying cardiovascular risk in individuals in order to better target the intensity of conventional therapy, and it may be useful in assessing response to treatment.Crosstalk between macro- and microcirculation in hypertension has important implications for pharmacological treatment. An antihypertensive regimen should abolish the vicious cycle between the increased resistance in the microcirculation and the increased stiffness of the larger arteries. Such treatment should be based on drugs with multiple actions on the vascular tree, or on drug combinations that target the various segments of the arterial system.Several blood pressure-independent mechanisms of large artery stiffness exist. Future considerations for clinical understanding of large artery stiffness should involve new drugs and new evaluation methods – with a focus on vascular health, for the initiation of cardiovascular prevention, for newly designed studies for treatment evaluation, and for new studies of drug combinations.Arterial stiffening is a sign of cardiovascular aging and is a major factor affecting the biomechanics of large arteries. Arterial stiffness is an attractive therapeutic target in terms of vascular aging. Healthy lifestyle, physical exercise, and smoking cessation are the most effective ways of preventing and treating early vascular aging. Long-term effects of cardiovascular drugs on arterial stiffness need to be further investigated.The emerging clinical data on the cardio ankle vascular index (CAVI) technique of arterial health assessment is presented, showing that the CAVI is elevated in aging, coronary artery diseases, chronic kidney disease, hypertension, diabetes mellitus, smoking, and stress. The CAVI decreased with the administration of statins, angiotensin II receptor blocking agents, and calcium channel blockers. The CAVI is suggested as an important predictor of cardiovascular diseases. Future development of a clinical understanding of large artery stiffness is important and should include consideration of new drugs and new evaluation methods, with a focus on vascular health aimed at cardiovascular prevention. PMID:23745049

Current status and future prospects of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) clinical trials in ovarian cancer.

PubMed

Cowan, Renee A; O'Cearbhaill, Roisin E; Zivanovic, Oliver; Chi, Dennis S

2017-08-01

The natural history of advanced-stage epithelial ovarian cancer is one of clinical remission after surgery and platinum/taxane-based intravenous (IV) and/or intraperitoneal (IP) chemotherapy followed by early or late recurrence in the majority of patients. Prevention of progression and recurrence remains a major hurdle in the management of ovarian cancer. Recently, many investigators have evaluated the use of normothermic and hyperthermic intraoperative IP drug delivery as a management strategy. This is a narrative review of the current status of clinical trials of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) in ovarian cancer and the future directions for this treatment strategy. The existing studies on HIPEC in patients with epithelial ovarian cancer are mostly retrospective in nature, are heterogeneous with regards to combined inclusion of primary and recurrent disease and lack unbiased data. Until data are available from evidence-based trials, it is reasonable to conclude that surgical cytoreduction and HIPEC is a rational and interesting, though still investigative, approach in the management of epithelial ovarian cancer, whose use should be employed within prospective clinical trials.

Towards Automating Clinical Assessments: A Survey of the Timed Up and Go (TUG)

PubMed Central

Sprint, Gina; Cook, Diane; Weeks, Douglas

2016-01-01

Older adults often suffer from functional impairments that affect their ability to perform everyday tasks. To detect the onset and changes in abilities, healthcare professionals administer standardized assessments. Recently, technology has been utilized to complement these clinical assessments to gain a more objective and detailed view of functionality. In the clinic and at home, technology is able to provide more information about patient performance and reduce subjectivity in outcome measures. The timed up and go (TUG) test is one such assessment recently instrumented with technology in several studies, yielding promising results towards the future of automating clinical assessments. Potential benefits of technological TUG implementations include additional performance parameters, generated reports, and the ability to be self-administered in the home. In this paper, we provide an overview of the TUG test and technologies utilized for TUG instrumentation. We then critically review the technological advancements and follow up with an evaluation of the benefits and limitations of each approach. Finally, we analyze the gaps in the implementations and discuss challenges for future research towards automated, self-administered assessment in the home. PMID:25594979

A 3D virtual reality ophthalmoscopy trainer.

PubMed

Wilson, Andrew S; O'Connor, Jake; Taylor, Lewis; Carruthers, David

2017-12-01

Performing eye examinations is an important clinical skill that medical students often find difficult to become proficient in. This paper describes the development and evaluation of an innovative 3D virtual reality (VR) training application to support learning these skills. The VR ophthalmoscope was developed by a clinical team and technologist using the unity game engine, smartphone and virtual reality headset. It has a series of tasks that include performing systematic eye examinations, identifying common eye pathologies and a knowledge quiz. As part of their clinical training, 15 fourth-year medical students were surveyed for their views on this teaching approach. The Technology Acceptance Model was used to evaluate perceived usefulness and ease of use. Data were also collected on the usability of the app, together with the students' written comments about it. Users agreed that the teaching approach improved their understanding of ophthalmoscopy (n = 14), their ability to identify landmarks in the eye (n = 14) and their ability to recognise abnormalities (n = 15). They found the app easy to use (n = 15), the teaching approach informative (n = 13) and that it would increase students' confidence when performing these tasks in future (n = 15). Performing eye examinations is an important clinical skill DISCUSSION: The evaluation showed that a VR app can successfully simulate the processes involved in performing eye examinations. The app was highly rated for all elements of perceived usefulness, ease of use and usability. Medical students stated that they would like to be taught other medical skills in this way in future. © 2017 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

The use of the OSCE in postgraduate education.

PubMed

Arnold, R C; Walmsley, A D

2008-08-01

The Objective Structured Clinical Examination (OSCE) is a method of assessing the clinical skills of undergraduates in medicine, dentistry and other health sciences and is employed increasingly in postgraduate education. To describe the application of the OSCE to the development of Lifelong Learning and Continuing Professional Development (CPD) for General Dental Practitioners (GDPs). A postgraduate course was designed as an OSCE for GDPs. The OSCE comprised 12 stations covering different aspects of general dentistry. After an introductory seminar outlining the aim of the course, the participants spent 7 min at each station. Each question or task required 10 answers and was designed to highlight areas of weakness or interest and to stimulate further study of the presenting topic. Solutions and answers were provided at each station for self-assessment along with a list of locally presented courses related to that subject. Participants were invited to leave contact details and to make suggestions for future postgraduate courses. The final session consisted of a group discussion and participants were invited to complete an evaluation form to express opinions on the course. The evaluation demonstrated that most candidates found participation in the OSCE stimulated their interest in CPD. The OSCE also highlighted areas of weakness in knowledge of certain clinical procedures. Group discussion confirmed that practitioners found the hands-on component valuable and that they were likely to participate in further OSCEs to enhance their CPD. Suggestions received during the discussion were used to modify the course. The OSCE course fulfilled its aim of assisting practitioners to organise their CPD. The reflective nature of the course was helpful in evaluating clinical knowledge and the unique multidisciplinary style fulfilled its objective in promoting thoughts regarding future study.

Using simulation pedagogy to teach clinical education skills: A randomized trial.

PubMed

Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

2016-05-01

Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

Surveying the orientation learning needs of clinical nursing instructors.

PubMed

Davidson, Kathleen M; Rourke, Liam

2012-02-17

The purpose of this study was to describe the knowledge and skills nurses need to be successful clinical instructors. A formal learning needs assessment was conducted to measure the orientation learning needs of new part-time clinical nursing faculty at one university. An existing, validated learning needs instrument was modified and administered online. The respondents (n=44; 16.6%) unanimously identified five essential learning needs for nursing clinical instructors, thus providing sound justification upon which to base an instructor orientation program. From these results, essential content for an orientation workshop to be followed by an online orientation course is outlined. Future research is needed to evaluate the outcomes of clinical instructor orientation; that is, whether participants have acquired the knowledge and skills needed to competently facilitate student learning in the clinical setting.

Addressing neuropsychiatric disturbances during rehabilitation after traumatic brain injury: current and future methods

PubMed Central

Arciniegas, David B.

2011-01-01

Cognitive, emotional, behavioral, and sensorimotor disturbances are the principal clinical manifestations of traumatic brain injury (TBI) throughout the early postinjury period. These post-traumatic neuropsychiatric disturbances present substantial challenges to patients, their families, and clinicians providing their rehabilitative care, the optimal approaches to which remain incompletely developed. In this article, a neuropsychiairically informed, neurobiologically anchored approach to understanding and meeting challenges is described. The foundation for thai approach is laid, with a review of clinical case definitions of TBI and clarification of their intended referents. The differential diagnosis of event-related neuropsychiatric disturbances is considered next, after which the clinical and neurobiological heterogeneity within the diagnostic category of TBI are discussed. The clinical manifestations of biomechanical force-induced brain dysfunction are described as a state of post-traumatic encephalopathy (PTE) comprising several phenomenologically distinct stages, PTE is then used as a framework for understanding and clinically evaluating the neuropsychiatric sequelae of TBI encountered commonly during the early post-injury rehabilitation period, and for considering the types and timings of neurorehabilitative interventions. Finally, directions for future research that may address productively the challenges to TBI rehabilitation presented by neuropsychiatric disturbances are considered. PMID:22034400

Gene and cell therapy for pancreatic cancer.

PubMed

Singh, Hans Martin; Ungerechts, Guy; Tsimberidou, Apostolia M

2015-04-01

The clinical outcomes of patients with pancreatic cancer are poor, and the limited success of classical chemotherapy underscores the need for new, targeted approaches for this disease. The delivery of genetic material to cells allows for a variety of therapeutic concepts. Engineered agents based on synthetic biology are under clinical investigation in various cancers, including pancreatic cancer. This review focuses on Phase I - III clinical trials of gene and cell therapy for pancreatic cancer and on future implications of recent translational research. Trials available in the US National Library of Medicine (www.clinicaltrials.gov) until February 2014 were reviewed and relevant published results of preclinical and clinical studies were retrieved from www.pubmed.gov . In pancreatic cancer, gene and cell therapies are feasible and may have synergistic antitumor activity with standard treatment and/or immunotherapy. Challenges are related to application safety, manufacturing costs, and a new spectrum of adverse events. Further studies are needed to evaluate available agents in carefully designed protocols and combination regimens. Enabling personalized cancer therapy, insights from molecular diagnostic technologies will guide the development and selection of new gene-based drugs. The evolving preclinical and clinical data on gene-based therapies can lay the foundation for future avenues improving patient care in pancreatic cancer.

Clinical audit in the final year of undergraduate medical education: towards better care of future generations.

PubMed

Mak, Donna B; Miflin, Barbara

2012-01-01

In Australia, in an environment undergoing rapidly changing requirements for health services, there is an urgent need for future practitioners to be knowledgeable, skilful and self-motivated in ensuring the quality and safety of their practice. Postgraduate medical education and vocational programs have responded by incorporating training in quality improvement into continuing professional development requirements, but undergraduate medical education has been slower to respond. This article describes the clinical audit programme undertaken by all students in the final year of the medical course at the University of Notre Dame, Fremantle, Australia, and examines the educational worth of this approach. Data were obtained from curricular documents, including the clinical audit handbook, and from evaluation questionnaires administered to students and supervisors. The clinical audit programme is based on sound educational principles, including situated and participatory learning and reflective practice. It has demonstrated multi-dimensional benefits for students in terms of learning the complexities of conducting an effective audit in professional practice, and for health services in terms of facilitating quality improvement. Although this programme was developed in a medical course, the concept is readily transferable to a variety of other health professional curricula in which students undertake clinical placements.

Neurofeedback as supplementary training for optimizing athletes' performance: A systematic review with implications for future research.

PubMed

Mirifar, Arash; Beckmann, Jürgen; Ehrlenspiel, Felix

2017-04-01

Self-regulation plays an important role in enhancing human performance. Neurofeedback is a promising noninvasive approach for modifying human brain oscillation and can be utilized in developing skills for self-regulation of brain activity. So far, the effectiveness of neurofeedback has been evaluated with regard to not only its application in clinical populations but also the enhancement of performance in general. However, reviews of the application of neurofeedback training in the sports domain are absent, although this application goes back to 1991, when it was first applied in archery. Sport scientists have shown an increasing interest in this topic in recent years. This article provides an overview of empirical studies examining the effects of neurofeedback in sports and evaluates these studies against cardinal and methodological criteria. Furthermore, it includes guidelines and suggestions for future evaluations of neurofeedback training in sports. Copyright © 2017 Elsevier Ltd. All rights reserved.

Sex Differences in Clinical Predictors of Suicidal Acts After Major Depression: A Prospective Study

PubMed Central

Oquendo, Maria A.; Bongiovi-Garcia, Mary E.; Galfalvy, Hanga; Goldberg, Pablo H.; Grunebaum, Michael F.; Burke, Ainsley K.; Mann, J. John

2013-01-01

Objective Whether sex differences exist in clinical risk factors associated with suicidal behavior is unknown. The authors postulated that among men with a major depressive episode, aggression, hostility, and history of substance misuse increase risk for future suicidal behavior, while depressive symptoms, childhood history of abuse, fewer reasons for living, and borderline personality disorder do so in depressed women. Method Patients with DSM-III-R major depression or bipolar disorder seeking treatment for a major depressive episode (N=314) were followed for 2 years. Putative predictors were tested with Cox proportional hazards regression analysis. Results During follow-up, 16.6% of the patients attempted or committed suicide. Family history of suicidal acts, past drug use, cigarette smoking, borderline personality disorder, and early parental separation each more than tripled the risk of future suicidal acts in men. For women, the risk for future suicidal acts was sixfold greater for prior suicide attempters; each past attempt increased future risk threefold. Suicidal ideation, lethality of past attempts, hostility, subjective depressive symptoms, fewer reasons for living, comorbid borderline personality disorder, and cigarette smoking also increased the risk of future suicidal acts for women. Conclusions These findings suggest that the importance of risk factors for suicidal acts differs in depressed men and women. This knowledge may improve suicide risk evaluation and guide future research on suicide assessment and prevention. PMID:17202555

Bridge to the future: nontraditional clinical settings, concepts and issues.

PubMed

Faller, H S; Dowell, M A; Jackson, M A

1995-11-01

Healthcare restructuring in the wake of healthcare reform places greater emphasis on primary healthcare. Clinical education in acute care settings and existing community health agencies are not compatible with teaching basic concepts, principles and skills fundamental to nursing. Problems of clients in acute care settings are too complex and clients in the community are often too dispersed for necessary faculty support and supervision of beginning nursing students. Nontraditional learning settings offer the baccalaureate student the opportunity to practice fundamental skills of care and address professional skills of negotiation, assertiveness, organization, collaboration and leadership. An overview of faculty designed clinical learning experiences in nontraditional sites such as McDonald's restaurants, inner city churches, YWCA's, the campus community and homes are presented. The legal, ethical and academic issues associated with nontraditional learning settings are discussed in relation to individual empowerment, decision making and evaluation. Implications for the future address the role of the students and faculty as they interact with the community in which they live and practice.

Applications for detection of acute kidney injury using electronic medical records and clinical information systems: workgroup statements from the 15(th) ADQI Consensus Conference.

PubMed

James, Matthew T; Hobson, Charles E; Darmon, Michael; Mohan, Sumit; Hudson, Darren; Goldstein, Stuart L; Ronco, Claudio; Kellum, John A; Bagshaw, Sean M

2016-01-01

Electronic medical records and clinical information systems are increasingly used in hospitals and can be leveraged to improve recognition and care for acute kidney injury. This Acute Dialysis Quality Initiative (ADQI) workgroup was convened to develop consensus around principles for the design of automated AKI detection systems to produce real-time AKI alerts using electronic systems. AKI alerts were recognized by the workgroup as an opportunity to prompt earlier clinical evaluation, further testing and ultimately intervention, rather than as a diagnostic label. Workgroup members agreed with designing AKI alert systems to align with the existing KDIGO classification system, but recommended future work to further refine the appropriateness of AKI alerts and to link these alerts to actionable recommendations for AKI care. The consensus statements developed in this review can be used as a roadmap for development of future electronic applications for automated detection and reporting of AKI.

Quantitative methods for evaluating the efficacy of thalamic deep brain stimulation in patients with essential tremor.

PubMed

Wastensson, Gunilla; Holmberg, Björn; Johnels, Bo; Barregard, Lars

2013-01-01

Deep brain stimulation (DBS) of the thalamus is a safe and efficient method for treatment of disabling tremor in patient with essential tremor (ET). However, successful tremor suppression after surgery requires careful selection of stimulus parameters. Our aim was to examine the possible use of certain quantitative methods for evaluating the efficacy of thalamic DBS in ET patients in clinical practice, and to compare these methods with traditional clinical tests. We examined 22 patients using the Essential Tremor Rating Scale (ETRS) and quantitative assessment of tremor with the stimulator both activated and deactivated. We used an accelerometer (CATSYS tremor Pen) for quantitative measurement of postural tremor, and a eurythmokinesimeter (EKM) to evaluate kinetic tremor in a rapid pointing task. The efficacy of DBS on tremor suppression was prominent irrespective of the method used. The agreement between clinical rating of postural tremor and tremor intensity as measured by the CATSYS tremor pen was relatively high (rs = 0.74). The agreement between kinetic tremor as assessed by the ETRS and the main outcome variable from the EKM test was low (rs = 0.34). The lack of agreement indicates that the EKM test is not comparable with the clinical test. Quantitative methods, such as the CATSYS tremor pen, could be a useful complement to clinical tremor assessment in evaluating the efficacy of DBS in clinical practice. Future studies should evaluate the precision of these methods and long-term impact on tremor suppression, activities of daily living (ADL) function and quality of life.

Evaluation of moral case deliberation at the Dutch Health Care Inspectorate: a pilot study.

PubMed

Seekles, Wike; Widdershoven, Guy; Robben, Paul; van Dalfsen, Gonny; Molewijk, Bert

2016-05-21

Moral case deliberation (MCD) as a form of clinical ethics support is usually implemented in health care institutions and educational programs. While there is no previous research on the use of clinical ethics support on the level of health care regulation, employees of regulatory bodies are regularly confronted with moral challenges. This pilot study describes and evaluates the use of MCD at the Dutch Health Care Inspectorate (IGZ). The objective of this pilot study is to investigate: 1) the current way of dealing with moral issues at the IGZ; 2) experience with and evaluation of MCD as clinical ethics support, and 3) future preferences and (perceived) needs regarding clinical ethics support for dealing with moral questions at the IGZ. We performed an explorative pilot study. The research questions were assessed by means of: 1) interviews with MCD participants during four focus groups; and 2) interviews with six key stakeholders at the IGZ. De qualitative data is illustrated by data from questionnaires on MCD outcomes, perspective taking and MCD evaluation. Professionals do not always recognize moral issues. Employees report a need for regular and structured moral support in health care regulation. The MCD meetings are evaluated positively. The most important outcomes of MCD are feeling secure and learning from others. Additional support is needed to successfully implement MCD at the Inspectorate. We conclude that the respondents perceive moral case deliberation as a useful form of clinical ethics support for dealing with moral questions and issues in health care regulation.

Utility of Vibratory Stimulation for Reducing Intraoral Injection Pain.

PubMed

Erdogan, Ozgur; Sinsawat, Anatachai; Pawa, Sudeep; Rintanalert, Duangtawan; Vuddhakanok, Suchada

2018-01-01

Intraoral local anesthesia injection is often perceived as a painful and anxiety-causing dental procedure. Vibration stimulus is one of the nonpharmacologic methods used to reduce unwanted sensations of local anesthesia injection. This clinical study evaluated the effectiveness of a recently introduced vibratory stimulation device in intraoral local anesthesia administration. Thirty-two subjects underwent 2 maxillary local anesthesia injections in 2 different sessions: 1 with conventional techniques and 1 with the aid of a vibratory stimulation device (DentalVibe). The pain levels were evaluated with a visual analog scale and the Wong-Baker FACES Pain Rating Scale. The subjects were asked to choose the preferred method for future injections. The data were evaluated statistically. There were no significant differences between the 2 injection methods with regard to either pain evaluation method. The preference of the subjects regarding future injection technique was evenly distributed between the groups. The vibratory stimulation device used in this study did not provide any reduction in pain level associated with maxillary infiltration local anesthesia administration.

Ambient Ionization Mass Spectrometry for Cancer Diagnosis and Surgical Margin Evaluation

PubMed Central

Ifa, Demian R.; Eberlin, Livia S.

2017-01-01

Background There is a clinical need for new technologies that would enable rapid disease diagnosis based on diagnostic molecular signatures. Ambient ionization mass spectrometry has revolutionized the means by which molecular information can be obtained from tissue samples in real time and with minimal sample pretreatment. New developments in ambient ionization techniques applied to clinical research suggest that ambient ionization mass spectrometry will soon become a routine medical tool for tissue diagnosis. Content This review summarizes the main developments in ambient ionization techniques applied to tissue analysis, with focus on desorption electrospray ionization mass spectrometry, probe electrospray ionization, touch spray, and rapid evaporative ionization mass spectrometry. We describe their applications to human cancer research and surgical margin evaluation, highlighting integrated approaches tested for ex vivo and in vivo human cancer tissue analysis. We also discuss the challenges for clinical implementation of these tools and offer perspectives on the future of the field. Summary A variety of studies have showcased the value of ambient ionization mass spectrometry for rapid and accurate cancer diagnosis. Small molecules have been identified as potential diagnostic biomarkers, including metabolites, fatty acids, and glycerophospholipids. Statistical analysis allows tissue discrimination with high accuracy rates (>95%) being common. This young field has challenges to overcome before it is ready to be broadly accepted as a medical tool for cancer diagnosis. Growing research in new, integrated ambient ionization mass spectrometry technologies and the ongoing improvements in the existing tools make this field very promising for future translation into the clinic. PMID:26555455

A nurse- and pharmacist-led treatment advice clinic for patients attending an HIV outpatient clinic.

PubMed

Griffiths, C; Miles, K; Aldam, D; Cornforth, D; Minton, J; Edwards, S; Williams, I

2007-05-01

This paper is a report of a study to map care pathways, examine the approach of different treatment advisors and explore the acceptability of a nurse- and pharmacist-led treatment advice clinic in order to aid decision-making for the future development and evaluation of the clinic. High levels of adherence to antiretroviral drugs are a prerequisite for a successful and durable virological and immunological response to HIV. Treatment guidelines acknowledge that adherence is a process, not a single event, and that adherence support must be integrated into clinical follow-up for all patients receiving these drugs. Data were collected between September 2004 and January 2005 through 17 consultation observations and 10 patient interviews in a specialist treatment advice clinic located within a central London HIV outpatient clinic providing care for over 2200 patients, of whom more than 1300 are taking highly active antiretroviral therapy. The nurses and pharmacist had similar consultation approaches, although follow-up care varied in extent. Benefits of the clinic approach included permitting patients to observe real tablets, tailoring regimens to lifestyles and telephone follow-up. These factors, particularly telephone support, were perceived by patients to assist with adherence. The role of telephone support, perceived to assist with initial adherence, requires further investigation. Future work is also needed to explore the health economics of this approach and to determine the actual impact of the clinic on clinical and adherence outcomes.

Differences in cultural beliefs and values among African American and European American men with prostate cancer.

PubMed

Hughes Halbert, Chanita; Barg, Frances K; Weathers, Benita; Delmoor, Ernestine; Coyne, James; Wileyto, E Paul; Arocho, Justin; Mahler, Brandon; Malkowicz, S Bruce

2007-07-01

Although cultural values are increasingly being recognized as important determinants of psychological and behavioral outcomes following cancer diagnosis and treatment, empirical data are not available on cultural values among men. This study evaluated differences in cultural values related to religiosity, temporal orientation, and collectivism among African American and European American men. Participants were 119 African American and European American men who were newly diagnosed with early-stage and locally advanced prostate cancer. Cultural values were evaluated by self-report using standardized instruments during a structured telephone interview. After controlling for sociodemographic characteristics, African American men reported significantly greater levels of religiosity (Beta = 24.44, P < .001) compared with European American men. African American men (Beta = 6.30, P < .01) also reported significantly greater levels of future temporal orientation. In addition, men with more aggressive disease (eg, higher Gleason scores) (Beta = 5.11, P < .01) and those who were pending treatment (Beta = -6.42, P < .01) reported significantly greater levels of future temporal orientation. These findings demonstrate that while ethnicity is associated with some cultural values, clinical experiences with prostate cancer may also be important. This underscores the importance of evaluating the effects of both ethnicity and clinical factors in research on the influence of cultural values on cancer prevention and control.

An overview of juveniles and school violence.

PubMed

Murakami, Saori; Rappaport, Nancy; Penn, Joseph V

2006-09-01

Despite the relative rarity of school shootings, targeted violence, and school-associated violent deaths, any youth who presents with words, gestures, or actions of a threatening or violent nature in a school setting should be assessed and referred for further evaluation by a mental health professional and, if clinically indicated, a forensic evaluator.The request for a juvenile risk assessment for future dangerousness requires careful delineation of role and agency; confidentiality issues; a comprehensive diagnostic evaluation of the youth; and a detailed assessment of the youth's perceived threat or problematic behavior. Various protective and risk factors and consideration of other individual, family, school/peer, and situational factors should also be explored.There is still much information that is unknown when considering school violence or targeted school violence. There is clearly a need for additional research on the identification of at-risk youths, the contributions and significance of various protective and risk factors, the impact of peer relationships, and perceived rejection, socioeconomic status, subtypes of aggression, and developmental stages. Examples of future research direction might include difference by gender, presence of affective or psychotic disorders, substance abuse, emerging characterologic disturbances, and physiologic markers, such as cortisol or serotonin. Additional research regarding best practices and the development of clinical guidelines or practice parameters is also needed.

Iranian Effective Clinical Nurse Instructor evaluation tool: Development and psychometric testing

PubMed Central

Shahsavari, Hooman; Yekta, Zohreh Parsa; Zare, Zahra; Sigaroodi, Abdolhossain Emami

2014-01-01

Background: Clinical education is the heart of the nursing education program. Effective nursing clinical instructors are needed for graduating the future qualified nurses. There is a well-developed body of knowledge about the effectiveness of clinical teaching and the instructors. However, translating this knowledge into a context-based evaluation tool for measuring the effectiveness of Iranian clinical nursing instructors remains a deficiency. The purpose of this study is to describe the development and psychometric testing process of an instrument to evaluate the characteristics of Iranian effective clinical nurse instructor. Materials and Methods: Following a precise review of Iranian literatures and expert consultation, 83 statements about the characteristics that make clinical nurse instructors effective were extracted. In the next phase, the psychometric properties of the instrument were established by looking at the content validity, face validity, and internal consistency. Content validity of the instrument was assessed based on the comments of an expert panel including 10 nursing faculty members. During this phase, 30 items of the instrument were omitted or merged. Face validity of the instrument was assured based on the advices of 10 nursing students and 10 nursing faculty members. Finally, in the pilot test, the data of 168 filled questionnaires were gathered and analyzed by an exploratory factor analysis to reduce the items and identify the factor structure of the instrument. Results: Through subsequent analyses, of the 83 items, 31 items were merged or omitted. At last, 52 retained items were divided into four subscales including student-centric behaviors, clinical performances, planning ability, and personality traits. The Cronbach's alpha level of the inventory was 0.96, with the value for each domain ranging from 0.87 to 0.94. Conclusions: Iranian Effective Clinical Nurse Instructor evaluation tool has acceptable psychometric properties and can be used in evaluating the effectiveness of clinical nursing instructors. PMID:24834081

A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual

PubMed Central

Sturt, Jackie; Taylor, Hafrun; Docherty, Andrea; Dale, Jeremy; Louise, Taylor

2006-01-01

Background The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews. Methods Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey. Results The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations. Conclusion This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended. PMID:17129376

Process Evaluation of a Community Garden at an Urban Outpatient Clinic.

PubMed

Milliron, Brandy-Joe; Vitolins, Mara Z; Gamble, Elizabeth; Jones, Robert; Chenault, Margaret C; Tooze, Janet A

2017-08-01

In addition to expediting patient recovery, community gardens that are associated with medical facilities can provide fresh produce to patients and their families, serve as a platform for clinic-based nutrition education, and help patients develop new skills and insights that can lead to positive health behavior change. While community gardening is undergoing resurgence, there is a strong need for evaluation studies that employ valid and reliable measures. The objective of this study was to conduct a process evaluation of a community garden program at an urban medical clinic to estimate the prevalence of patient awareness and participation, food security, barriers to participation, and personal characteristics; garden volunteer satisfaction; and clinic staff perspectives in using the garden for patient education/treatment. Clinic patients (n = 411) completed a community garden participation screener and a random sample completed a longer evaluation survey (n = 152); garden volunteers and medical staff completed additional surveys. Among patients, 39% had heard of and 18% had received vegetables from the garden; the greatest barrier for participation was lack of awareness. Volunteers reported learning about gardening, feeling more involved in the neighborhood, and environmental concern; and medical staff endorsed the garden for patient education/treatment. Comprehensive process evaluations can be utilized to quantify benefits of community gardens in medical centers as well as to point out areas for further development, such as increasing patient awareness. As garden programming at medical centers is formalized, future research should include systematic evaluations to determine whether this unique component of the healthcare environment helps improve patient outcomes.

Psychometric Evaluation of the MMPI-2/MMPI-2-RF Restructured Clinical Scales in an Israeli Sample.

PubMed

Shkalim, Eleanor

2015-10-01

The current study cross-culturally evaluated the psychometric properties of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2)/MMPI-2-Restructured Form Restructured Clinical (RC) Scales in psychiatric settings in Israel with a sample of 100 men and 133 women. Participants were administered the MMPI-2 and were rated by their therapists on a 188-item Patient Description Form. Results indicated that in most instances the RC Scales demonstrated equivalent or better internal consistencies and improved intercorrelation patterns relative to their clinical counterparts. Furthermore, external analyses revealed comparable or improved convergent validity (with the exceptions of Antisocial Behavior [RC4] and Ideas of Persecution [RC6] among men), and mostly greater discriminant validity. Overall, the findings indicate that consistent with previous findings, the RC Scales generally exhibit comparable to improved psychometric properties over the Clinical Scales. Implications of the results, limitations, and recommendations for future research are discussed. © The Author(s) 2014.

Innovations in human genetics education. Incorporation of genetics into a problem-based medical school curriculum.

PubMed Central

Swinford, A E; McKeag, D B

1990-01-01

There has been recent interest in the development of problem-based human genetics curricula in U.S. medical schools. The College of Human Medicine at Michigan State University has had a problem-based curriculum since 1974. The vertical integration of genetics within the problem-based curriculum, called "Track II," has recently been revised. On first inspection, the curriculum appeared to lack a significant genetics component; however, on further analysis it was found that many genetics concepts were covered in the biochemistry, microbiology, pathology, and clinical science components. Both basic science concepts and clinical applications of genetics are covered in the curriculum by providing appropriate references for basic concepts and including inherited conditions within the differential diagnosis in the cases studied. Evaluations consist of a multiple-choice content exam and a modified essay exam based on a clinical case, allowing evaluation of both basic concepts and problem-solving ability. This curriculum prepares students to use genetics in a clinical context in their future careers. PMID:2220816

Novel strategies in immunotherapy for allergic diseases.

PubMed

Rajakulendran, Mohana; Tham, Elizabeth Huiwen; Soh, Jian Yi; Van Bever, H P

2018-04-01

Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies. Future approaches may include fungal compounds, parasitic molecules, vitamin D, and traditional Chinese herbs. More robust comparative clinical trials are needed to evaluate the safety, clinical efficacy, and cost effectiveness of various adjuvants in order to determine ideal candidates in disease-specific and allergen-specific models. Other suggested approaches to further optimize outcomes of IT include early introduction of IT during an optimal window period. Alternative routes of administration of IT to optimize delivery and yet minimize potential side effects require further evaluation for safety and efficacy before they can be recommended.

Clinical evaluation of post-operative cerebral infarction in traumatic epidural haematoma.

PubMed

Zhang, Suojun; Wang, Sheng; Wan, Xueyan; Liu, Shengwen; Shu, Kai; Lei, Ting

2017-01-01

Patients with traumatic epidural haematoma, undergoing the prompt and correct treatment, usually have favourable outcomes. However, secondary cerebral infarction may be life-threatening condition, as it is difficult to be identified before neurological impairment occurs. To evaluate the clinical data of patients with traumatic EDH and assess potential risk factors for post-operative cerebral infarction. The clinical data of patients with traumatic EDH were collected and analysed retrospectively. The univariate analysis revealed 10 potential risk factors (the haematoma location, volume, the largest thickness and mid-line shift, basal cisterns compression, traumatic subarachnoid haemorrhage, pupil dilatation, pre-operative Glasgow Coma Scale score, ∆GCS and intraoperative brain pressure) for cerebral infarction with statistically significant difference. Of these factors, haematoma volume and basal cistern compression turned out to be the most significant risk factors through final multivariate logistic regression analysis. The findings of this study can provide predictive factors for development of cerebral infarction and information for clinical decision-making and future studies.

The Future of Clinical Education: Using Futuristic Scenarios to Explore Allied Health Deans' Perspectives on Clinical Education.

PubMed

Romig, Barbara D; Tucker, Ann W; Hewitt, Anne M; O'Sullivan Maillet, Julie

2017-01-01

There is limited information and consensus on the future of clinical education. The Delphi technique was selected to identify agreement among Association of Schools of Allied Health Professions' (ASAHP) allied health deans on the future (2018-2023) of allied health (AH) clinical education. Sixty-one AH deans, 54.9% (61 of 111) of the ASAHP membership, expressed opinions about clinical education through a three-round Delphi study. In conjunction with a conceptual model, four futuristic scenarios were used to encourage deans' feedback on the key factors impacting the future of clinical education. The responses to the four scenarios showed ways the external environment influences which activities the deans recommend. The results presented, by individual scenario and in totality, provide relevant and timely information on the importance and transformation of AH clinical education and its future. Futuristic scenarios, in combination with the Delphi technique, generated information where little exists specific to AH deans' perspectives on AH clinical education. The results offer deans opportunities for future strategic improvements. The use of the futuristic scenarios was suitable for guiding deans' responses and reaching agreement on the future of AH clinical education. These contributions reflect the imminent conditions and healthcare environment identified in the various scenarios and provide additional insight on key factors impacting the future for AH clinical education.

Longitudinal effects of medical students' communication skills on future performance.

PubMed

Dong, Ting; LaRochelle, Jeffrey S; Durning, Steven J; Saguil, Aaron; Swygert, Kimberly; Artino, Anthony R

2015-04-01

The Essential Elements of Communication (EEC) were developed from the Kalamazoo consensus statement on physician-patient communication. The Uniformed Services University of the Health Sciences (USU) has adopted a longitudinal curriculum to use the EEC both as a learning tool during standardized patient encounters and as an evaluation tool culminating with the end of preclerkship objective-structured clinical examinations (OSCE). Medical educators have recently emphasized the importance of teaching communication skills, as evidenced by the United States Medical Licensing Examination testing both the integrated clinical encounter (ICE) and communication and interpersonal skills (CIS) within the Step 2 Clinical Skills exam (CS). To determine the associations between students' EEC OSCE performance at the end of the preclerkship period with later communication skills assessment and evaluation outcomes in the context of a longitudinal curriculum spanning both undergraduate medical education and graduate medical education. Retrospective data from preclerkship (overall OSCE scores and EEC OSCE scores) and clerkship outcomes (internal medicine [IM] clinical points and average clerkship National Board of Medical Examiners [NBME] scores) were collected from 167 USU medical students from the class of 2011 and compared to individual scores on the CIS and ICE components of Step 2 CS, as well as to the communication skills component of the program directors' evaluation of trainees during their postgraduate year 1 (PGY-1) residency. In addition to bivariate Pearson correlation analysis, we conducted multiple linear regression analysis to examine the predictive power of the EEC score beyond the IM clerkship clinical points and the average NBME Subject Exams score on the outcome measures. The EEC score was a significant predictor of the CIS score and the PGY-1 communication skills score. Beyond the average NBME Subject Exams score and the IM clerkship clinical points, the EEC score explained an additional 13% of the variance in the Step 2 CIS score and an additional 6% of the variance in the PGY-1 communication skills score. In addition, the EEC score was more closely associated with the CIS score than the ICE score. The use of a standardized approach with a communication tool like the EEC can help explain future performance in communication skills independent of other education outcomes. In the context of a longitudinal curriculum, this information may better inform medical educators on learners' communication capabilities and more accurately direct future remediation efforts. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

Development and evaluation of a risk communication curriculum for medical students.

PubMed

Han, Paul K J; Joekes, Katherine; Elwyn, Glyn; Mazor, Kathleen M; Thomson, Richard; Sedgwick, Philip; Ibison, Judith; Wong, John B

2014-01-01

To develop, pilot, and evaluate a curriculum for teaching clinical risk communication skills to medical students. A new experience-based curriculum, "Risk Talk," was developed and piloted over a 1-year period among students at Tufts University School of Medicine. An experimental study of 2nd-year students exposed vs. unexposed to the curriculum was conducted to evaluate the curriculum's efficacy. Primary outcome measures were students' objective (observed) and subjective (self-reported) risk communication competence; the latter was assessed using an Observed Structured Clinical Examination (OSCE) employing new measures. Twenty-eight 2nd-year students completed the curriculum, and exhibited significantly greater (p<.001) objective and subjective risk communication competence than a convenience sample of 24 unexposed students. New observational measures of objective competence in risk communication showed promising evidence of reliability and validity. The curriculum was resource-intensive. The new experience-based clinical risk communication curriculum was efficacious, although resource-intensive. More work is needed to develop the feasibility of curriculum delivery, and to improve the measurement of competence in clinical risk communication. Risk communication is an important advanced communication skill, and the Risk Talk curriculum provides a model educational intervention and new assessment tools to guide future efforts to teach and evaluate this skill. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

[Medical treatment of endometriosis: Hormonal treatment of pain, impact on evolution and future perspectives].

PubMed

Geoffron, Sophie; Legendre, Guillaume; Daraï, Emile; Chabbert-Buffet, Nathalie

2017-12-01

Endometriosis is a chronic painful disease, for which hormone therapy is usually offered as a first line option to women not willing to conceive. To analyse and synthesize the literature, from 2006 onwards, on pain control, and disease evolution in oemn using combined hormonal contraceptives, progestins and GnRH analogs. Data on other current and future treatment perspectives is included as well. Medline (Pubmed), the Cochrane Library, and endometriosis treatment recommendations published by European Society of Human Reproduction and Embryology (ESHRE), National Institute for health and Care Excellence (NICE), American College of Obstetricians and Gynecologists (ACOG), Royal College of Obstetricians and Gynaecologists (RCOG) and Société des Obstétriciens et Gynécologues du Canada (SOGC). Meta-analysis and clinical trials are included. Study quality is heterogeneous in general. Hormone therapy inconstantly allows pain relief and prevention of endometrioma and rectovaginal wall nodules recurrence. Available molecules and routes of administration as well as risk benefit balance are evaluated. Data on future perspectives are limited to date and do not allow use in routine. Hormonal treatment of endometriosis relies on combined hormonal contraceptives (using different routes of administration), progestins and particularly the levonorgestrel-releasing IUS, and GnRH analogs as a last option, in combination with an add-back therapy. Promising alternatives are currently under preclinical and clinical evaluation. Copyright © 2017. Published by Elsevier Masson SAS.

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

Clinical use of cardiac PET/MRI: current state-of-the-art and potential future applications.

PubMed

Krumm, Patrick; Mangold, Stefanie; Gatidis, Sergios; Nikolaou, Konstantin; Nensa, Felix; Bamberg, Fabian; la Fougère, Christian

2018-05-01

Combined PET/MRI is a novel imaging method integrating the advances of functional and morphological MR imaging with PET applications that include assessment of myocardial viability, perfusion, metabolism of inflammatory tissue and tumors, as well as amyloid deposition imaging. As such, PET/MRI is a promising tool to detect and characterize ischemic and non-ischemic cardiomyopathies. To date, the greatest benefit may be expected for diagnostic evaluation of systemic diseases and cardiac masses that remain unclear in cardiac MRI, as well as for clinical and scientific studies in the setting of ischemic cardiomyopathies. Diagnosis and therapeutic monitoring of cardiac sarcoidosis has the potential of a possible 'killer-application' for combined cardiac PET/MRI. In this article, we review the current evidence and discuss current and potential future applications of cardiac PET/MRI.

PhysioNet: physiologic signals, time series and related open source software for basic, clinical, and applied research.

PubMed

Moody, George B; Mark, Roger G; Goldberger, Ary L

2011-01-01

PhysioNet provides free web access to over 50 collections of recorded physiologic signals and time series, and related open-source software, in support of basic, clinical, and applied research in medicine, physiology, public health, biomedical engineering and computing, and medical instrument design and evaluation. Its three components (PhysioBank, the archive of signals; PhysioToolkit, the software library; and PhysioNetWorks, the virtual laboratory for collaborative development of future PhysioBank data collections and PhysioToolkit software components) connect researchers and students who need physiologic signals and relevant software with researchers who have data and software to share. PhysioNet's annual open engineering challenges stimulate rapid progress on unsolved or poorly solved questions of basic or clinical interest, by focusing attention on achievable solutions that can be evaluated and compared objectively using freely available reference data.

Quality Measures for Dialysis: Time for a Balanced Scorecard

PubMed Central

2016-01-01

Recent federal legislation establishes a merit-based incentive payment system for physicians, with a scorecard for each professional. The Centers for Medicare and Medicaid Services evaluate quality of care with clinical performance measures and have used these metrics for public reporting and payment to dialysis facilities. Similar metrics may be used for the future merit-based incentive payment system. In nephrology, most clinical performance measures measure processes and intermediate outcomes of care. These metrics were developed from population studies of best practice and do not identify opportunities for individualizing care on the basis of patient characteristics and individual goals of treatment. The In-Center Hemodialysis (ICH) Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey examines patients' perception of care and has entered the arena to evaluate quality of care. A balanced scorecard of quality performance should include three elements: population-based best clinical practice, patient perceptions, and individually crafted patient goals of care. PMID:26316622

Malformations of cortical development: clinical spectrum in a series of 101 patients and review of the literature (Part I).

PubMed

Güngör, Serdal; Yalnizoğlu, Dilek; Turanli, Güzide; Saatçi, Işil; Erdoğan-Bakar, Emel; Topçu, Meral

2007-01-01

Patients with malformations of cortical development (MCD) present with a wide spectrum of clinical manifestations ranging from asymptomatic cases to those with epilepsy and neurodevelopmental problems. Thorough clinical delineation of patients with MCD may provide clues for future phenotype-genotype correlation studies. We studied clinical features of patients with MCD, including developmental risk factors and family history. We evaluated 10 patients with MCD at Hacettepe University Children's Hospital, Department of Pediatric Neurology. All patients underwent neurological evaluation with detailed medical and family history, and neuropsychological evaluation. Routine EEG and MRI were obtained. The patients were between 1 month and 19 years of age (mean: 6.1 +/- 4.4 years). Fifty-four patients were diagnosed with polymicrogyria (PMG), 23 patients with lissencephaly, 12 patients with schizencephaly, and 12 patients with heterotopia. Parents were relatives in 31.7% of the cases; consanguinity was most common in patients with lissencephaly and other MCDs with diffuse/bilateral involvement. Initial clinical presentation was seizures in 61.4% of the cases, developmental delays in 12.9%, and microcephaly in 9.9%. Neurological evaluation revealed most severe abnormalities in patients with lissencephaly, and relatively better outcome in patients with heterotopias. Cognitive functions were better in patients with heterotopias compared to other groups. Overall, 71.3% of patients ha epilepsy. In conclusion, initial presentation and clinical course of patients with MCD are variable and seem to be correlated with the extent of cortical involvement. Epilepsy and mental retardation are the most common problems. The most severe clinical outcome was seen in patients with lissencephaly.

Assessing the feasibility of mobile phones for follow-up of acutely unwell children presenting to village clinics in rural northern Malawi.

PubMed

Hardy, Victoria; Hsieh, Jenny; Chirambo, Baxter; Wu, Tsung-Shu Joseph; O'Donoghue, John; Muula, Adamson S; Thompson, Matthew

2017-03-01

Patient follow-up is a routine component of clinical practice and valuable for evaluating the effectiveness of interventions, but because of the broad dispersion of health facilities and lack of standardised medical reporting in Malawi, collecting patient outcome data can be challenging. Increasing accessibility and affordability of mobile technology in resource-poor settings may facilitate patient follow-up in the community. The objective of this study was to evaluate the potential utility of mobile phones for collecting follow-up clinical data from parents or caregivers of acutely unwell under-5 children, for intervention evaluation purposes. Parents' or caregivers' mobile phone numbers were obtained by health surveillance assistants (HSAs) during study enrollment. Guardians who provided a telephone number were contacted by the study team to establish re-consultations or hospitalisations of their child(ren) within 14 days of recruitment. Health records at village clinics and higher-level health facilities were hand-searched to identify or confirm presentations and abstract clinical data. 87 out of 149 (58.4%) guardians provided a mobile telephone number, of whom the study team could contact 44 (29.5%). Seven guardians stated they took their child for further treatment: three of these returned to village clinics and four presented to secondary care facilities; attendance could only be confirmed from health records for one child. With continued expansion of cellular network coverage and mobile ownership in Malawi, mobile phones may facilitate collection of patient outcomes for intervention evaluation purposes. Future consideration should also be given to integrating mobile technologies into HSA clinical practice.

Evidence-Based Indicators of Neuropsychological Change in the Individual Patient: Relevant Concepts and Methods

PubMed Central

Duff, Kevin

2012-01-01

Repeated assessments are a relatively common occurrence in clinical neuropsychology. The current paper will review some of the relevant concepts (e.g., reliability, practice effects, alternate forms) and methods (e.g., reliable change index, standardized based regression) that are used in repeated neuropsychological evaluations. The focus will be on the understanding and application of these concepts and methods in the evaluation of the individual patient through examples. Finally, some future directions for assessing change will be described. PMID:22382384

Nailfold Capillaroscopy and Clinical Applications in Systemic Sclerosis.

PubMed

Smith, Vanessa; Thevissen, Kristof; Trombetta, Amelia C; Pizzorni, Carmen; Ruaro, Barbara; Piette, Yves; Paolino, Sabrina; De Keyser, Filip; Sulli, Alberto; Melsens, Karin; Cutolo, Maurizio

2016-07-01

Capillary microscopy is a safe and non-invasive tool to evaluate the morphology of the microcirculation typically affected in SSc. Next to being paramount for the "(very) early" diagnosis of SSc eyes are also geared toward capillaroscopy with the aim to be able to use it as a biomarker, especially in the prediction of future occurrence of DU. The following review will explain what capillary microscopy is and will focus additionally on studies evaluating the association between capillaroscopy and DU. © 2016 John Wiley & Sons Ltd.

The role of ultrasound elastographic techniques in chronic liver disease: current status and future perspectives.

PubMed

Piscaglia, Fabio; Marinelli, Sara; Bota, Simona; Serra, Carla; Venerandi, Laura; Leoni, Simona; Salvatore, Veronica

2014-03-01

This review illustrates the state of the art clinical applications and the future perspectives of ultrasound elastographic methods for the evaluation of chronic liver diseases, including the most widely used and validated technique, transient elastography, followed by shear wave elastography and strain imaging elastography. Liver ultrasound elastography allows the non-invasive evaluation of liver stiffness, providing information regarding the stage of fibrosis, comparable to liver biopsy which is still considered the gold standard; in this way, it can help physicians in managing patients, including the decision as to when to start antiviral treatment. The characterization of focal liver lesions and the prognostic role of the elastographic technique in the prediction of complications of cirrhosis are still under investigation. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Lessons From LEADER - All-round Leadership.

PubMed

Kalra, Sanjay

2016-08-01

The large multinational, randomised, double-blind LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A Long Term Evaluation) trial recently reported the cardiovascular (CV) benefits achieved with liraglutide therapy in type 2 diabetes mellitus (T2DM). This editorial analyses the primary and secondary CV outcomes (CVO) results of the LEADER trial, and discusses the impact these will have on clinical practice of diabetes in specific, and medicine in general. It delves into the evolution of clinical and biochemical outcomes used in diabetes, and discusses the role of liraglutide in shaping future outcomes. The editorial describes the potential role of liraglutide in primary, secondary and tertiary prevention of CV disease (CVD), and suggests exaptation of this molecule for use in cardiology, nephrology and neurology.

Novel Applications of Metabolomics in Personalized Medicine: A Mini-Review.

PubMed

Li, Bingbing; He, Xuyun; Jia, Wei; Li, Houkai

2017-07-13

Interindividual variability in drug responses and disease susceptibility is common in the clinic. Currently, personalized medicine is highly valued, the idea being to prescribe the right medicine to the right patient. Metabolomics has been increasingly applied in evaluating the therapeutic outcomes of clinical drugs by correlating the baseline metabolic profiles of patients with their responses, i.e., pharmacometabonomics, as well as prediction of disease susceptibility among population in advance, i.e., patient stratification. The accelerated advance in metabolomics technology pinpoints the huge potential of its application in personalized medicine. In current review, we discussed the novel applications of metabolomics with typical examples in evaluating drug therapy and patient stratification, and underlined the potential of metabolomics in personalized medicine in the future.

Dissemination and implementation science in program evaluation: A telemental health clinical consultation case example.

PubMed

Arora, Prerna G; Connors, Elizabeth H; Blizzard, Angela; Coble, Kelly; Gloff, Nicole; Pruitt, David

2017-02-01

Increased attention has been placed on evaluating the extent to which clinical programs that support the behavioral health needs of youth have effective processes and result in improved patient outcomes. Several theoretical frameworks from dissemination and implementation (D&I) science have been put forth to guide the evaluation of behavioral health program implemented in the context of real-world settings. Although a strong rationale for the integration of D&I science in program evaluation exists, few examples exist available to guide the evaluator in integrating D&I science in the planning and execution of evaluation activities. This paper seeks to inform program evaluation efforts by outlining two D&I frameworks and describing their integration in program evaluation design. Specifically, this paper seeks to support evaluation efforts by illustrating the use of these frameworks via a case example of a telemental health consultation program in pediatric primary care designed to improve access to behavioral health care for children and adolescents in rural settings. Lessons learned from this effort, as well as recommendations regarding the future evaluation of programs using D&I science to support behavioral health care in community-based settings are discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

ACCP: economic evaluations of clinical pharmacy services: 2001-2005.

PubMed

Perez, Alexandra; Doloresco, Fred; Hoffman, James M; Meek, Patrick D; Touchette, Daniel R; Vermeulen, Lee C; Schumock, Glen T

2009-01-01

The objectives of this review were to summarize and evaluate studies that measured the economic impact of clinical pharmacy services published between 2001 and 2005 (inclusive) and to provide guidance on methodologic considerations to individuals performing such research in the future. A systematic literature search using the MEDLINE and International Pharmaceutical Abstracts databases was conducted to identify published economic evaluations of clinical pharmacy services. Studies were screened and then randomly assigned to reviewers, who reassessed inclusion and exclusion criteria and abstracted prespecified data from each study. Among the many characteristics examined in each study were study design and type of economic evaluation, setting and type of clinical pharmacy service, study quality, and results. Ninety-three articles were included in the final analysis. These studies were published in 43 different journals, most of which (68 [73.1%]) were pharmacy-based. Most studies were performed in hospitals (40 [43.0%]), ambulatory care clinics or physician's offices (20 [21.5%]), or community pharmacies (16 [17.2%]). The most common types of clinical pharmacy services evaluated were general pharmacotherapeutic monitoring services (32 [34.4%]), target drug programs (27 [29%]), and disease state-management services (21 [22.6%]). Full economic evaluations were performed in just less than half (45 [48.4%]) of the studies, and a positive economic benefit associated with clinical pharmacy services was noted in 31 (69%) of the 45 studies. Among 15 studies reporting data necessary to determine a benefit:cost ratio, the pooled median value was 4.81:1-meaning that for every $1 invested in clinical pharmacy services, $4.81 was achieved in reduced costs or other economic benefits. The quality of studies varied widely, with less than one half considered to be good to fair (40 [43.0%]); however, the proportion of studies using appropriate study designs increased compared with previous reviews. Based on the evidence examined in this review, clinical pharmacy services continue to provide a significant return on investment, but improvements are still needed in the methods used to evaluate the economic impact of these services.

The MAPP research network: design, patient characterization and operations.

PubMed

Landis, J Richard; Williams, David A; Lucia, M Scott; Clauw, Daniel J; Naliboff, Bruce D; Robinson, Nancy A; van Bokhoven, Adrie; Sutcliffe, Siobhan; Schaeffer, Anthony J; Rodriguez, Larissa V; Mayer, Emeran A; Lai, H Henry; Krieger, John N; Kreder, Karl J; Afari, Niloofar; Andriole, Gerald L; Bradley, Catherine S; Griffith, James W; Klumpp, David J; Hong, Barry A; Lutgendorf, Susan K; Buchwald, Dedra; Yang, Claire C; Mackey, Sean; Pontari, Michel A; Hanno, Philip; Kusek, John W; Mullins, Chris; Clemens, J Quentin

2014-08-01

The "Multidisciplinary Approach to the Study of Chronic Pelvic Pain" (MAPP) Research Network was established by the NIDDK to better understand the pathophysiology of urologic chronic pelvic pain syndromes (UCPPS), to inform future clinical trials and improve clinical care. The evolution, organization, and scientific scope of the MAPP Research Network, and the unique approach of the network's central study and common data elements are described. The primary scientific protocol for the Trans-MAPP Epidemiology/Phenotyping (EP) Study comprises a multi-site, longitudinal observational study, including bi-weekly internet-based symptom assessments, following a comprehensive in-clinic deep-phenotyping array of urological symptoms, non-urological symptoms and psychosocial factors to evaluate men and women with UCPPS. Healthy controls, matched on sex and age, as well as "positive" controls meeting the non-urologic associated syndromes (NUAS) criteria for one or more of the target conditions of Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) or Irritable Bowel Syndrome (IBS), were also evaluated. Additional, complementary studies addressing diverse hypotheses are integrated into the Trans-MAPP EP Study to provide a systemic characterization of study participants, including biomarker discovery studies of infectious agents, quantitative sensory testing, and structural and resting state neuroimaging and functional neurobiology studies. A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies. Recruitment into the central study occurred at six Discovery Sites in the United States, resulting in a total of 1,039 enrolled participants, exceeding the original targets. The biospecimen collection rate at baseline visits reached nearly 100%, and 279 participants underwent common neuroimaging through a standardized protocol. An extended follow-up study for 161 of the UCPPS participants is ongoing. The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS. Findings are expected to provide significant advances in understanding UCPPS pathophysiology that will ultimately inform future clinical trials and lead to improvements in patient care. Furthermore, the structure and methodologies developed by the MAPP Network provide the foundation upon which future studies of other urologic or non-urologic disorders can be based. ClinicalTrials.gov identifier: NCT01098279 "Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)". http://clinicaltrials.gov/show/NCT01098279.

Clinical Research: A Psychotherapeutic Assessment Model for Siblings in Care

ERIC Educational Resources Information Center

Hindle, Debbie

2007-01-01

This paper focuses on the aspects of a qualitative research project that examines an assessment protocol for the placement of siblings in foster care and/or future adoption. A brief description of the background to the study and the research design is given. Evaluating the material from the quantitative instruments used and the psychotherapeutic…

Future role of MR elastography in tissue engineering and regenerative medicine.

PubMed

Othman, Shadi F; Xu, Huihui; Mao, Jeremy J

2015-05-01

Tissue engineering (TE) has been introduced for more than 25 years without a boom in clinical trials. More than 70 TE-related start-up companies spent more than $600 million/year, with only two FDA-approved tissue-engineered products. Given the modest performance in clinically approved organs, TE is a tenaciously promising field. The TE community is advocating the application of clinically driven methodologies in large animal models enabling clinical translation. This challenge is hindered by the scarcity of tissue biopsies and the absence of standardized evaluation tools, but can be negated through non-invasive assessment of growth and integration, with reduced sample size and low cost. Solving this issue will speed the transition to cost-efficient clinical studies. In this paper we: (a) introduce magnetic resonance elastography to the tissue-engineering and regenerative medicine (TERM) community; (b) review recent MRE applications in TERM; and (c) discuss future directions of MRE in TERM. We have used MRE to study engineered tissues both in vitro and in vivo, where the mechanical properties of mesenchymally derived constructs were progressively monitored before and after tissues were implanted in mouse models. This study represents a stepping stone toward the applications of MRE in directing clinical trials with low cost and likely expediting the translation to more relevantly large animal models and clinical trials. Copyright © 2013 John Wiley & Sons, Ltd.

A prospective evaluation of whole-exome sequencing as a first-tier molecular test in infants with suspected monogenic disorders.

PubMed

Stark, Zornitza; Tan, Tiong Y; Chong, Belinda; Brett, Gemma R; Yap, Patrick; Walsh, Maie; Yeung, Alison; Peters, Heidi; Mordaunt, Dylan; Cowie, Shannon; Amor, David J; Savarirayan, Ravi; McGillivray, George; Downie, Lilian; Ekert, Paul G; Theda, Christiane; James, Paul A; Yaplito-Lee, Joy; Ryan, Monique M; Leventer, Richard J; Creed, Emma; Macciocca, Ivan; Bell, Katrina M; Oshlack, Alicia; Sadedin, Simon; Georgeson, Peter; Anderson, Charlotte; Thorne, Natalie; Melbourne Genomics Health Alliance; Gaff, Clara; White, Susan M

2016-11-01

To prospectively evaluate the diagnostic and clinical utility of singleton whole-exome sequencing (WES) as a first-tier test in infants with suspected monogenic disease. Singleton WES was performed as a first-tier sequencing test in infants recruited from a single pediatric tertiary center. This occurred in parallel with standard investigations, including single- or multigene panel sequencing when clinically indicated. The diagnosis rate, clinical utility, and impact on management of singleton WES were evaluated. Of 80 enrolled infants, 46 received a molecular genetic diagnosis through singleton WES (57.5%) compared with 11 (13.75%) who underwent standard investigations in the same patient group. Clinical management changed following exome diagnosis in 15 of 46 diagnosed participants (32.6%). Twelve relatives received a genetic diagnosis following cascade testing, and 28 couples were identified as being at high risk of recurrence in future pregnancies. This prospective study provides strong evidence for increased diagnostic and clinical utility of singleton WES as a first-tier sequencing test for infants with a suspected monogenic disorder. Singleton WES outperformed standard care in terms of diagnosis rate and the benefits of a diagnosis, namely, impact on management of the child and clarification of reproductive risks for the extended family in a timely manner.Genet Med 18 11, 1090-1096.

A Qualitative Exploration of a Clinical Ethicist's Role and Contributions During Family Meetings.

PubMed

Bruce, Courtenay R; Bibler, Trevor M; Pena, Adam M; Kusin, Betsy

2016-12-01

Despite the interpersonal nature of family meetings and the frequency in which they occur, the clinical ethics literature is devoid of any rich descriptions of what clinical ethicists should actually be doing during family meetings. Here, we propose a framework for describing and understanding "transitioning" facilitation skills based on a retrospective review of our internal documentation of 100 consecutive cases (June 01, 2013-December 31, 2014) wherein a clinical ethicist facilitated at least one family meeting. The internal documents were analyzed using qualitative methodologies, i.e., "codes", to identify emergent themes. We identified four different transitioning strategies clinical ethicists use to reach a meaningful resolution. These transitioning strategies serve as a jumping-off point for additional analyses, future research, evaluating clinical ethics consultation, and overall performance improvement of a consultation service.

Rib fracture as a predictor of future fractures in young and older postmenopausal women: National Osteoporosis Risk Assessment (NORA)

PubMed Central

Sajjan, S. G.; Barrett-Connor, E.; McHorney, C. A.; Miller, P. D.; Sen, S. S.; Siris, E.

2013-01-01

Summary A rib fracture history after age 45 was associated with a 5.4-fold increase in new rib fracture risk and a 2.4-fold increase in risk of any new clinical fracture in 155,031 postmenopausal women. A rib fracture history suggests osteoporosis and should be considered when evaluating patients for interventions to prevent fractures. Introduction Until recently, little attention was paid to rib fracture as an osteoporosis marker. Emerging evidence suggests rib fracture may be an osteoporotic fracture in men and women. We report the 5-year independent association between baseline rib fracture histories and self-reported future fractures by age (decade) in the NORA cohort (155,031 postmenopausal women, 50–99 years). Methods Participants reported fracture history and responded to follow-up surveys at years 1, 3, or 6. Women with a baseline rib fracture history without other fractures were compared with women with no fracture. Results At baseline, 4,758 (3.07%) women reported a rib fracture history without other fractures; 6,300 women reported 6,830 new clinical fractures, including wrist (2,271), rib (1,891), spine (1,136), hip (941), and forearm (591). Adjusted relative risk (ARR) values (95% confidence interval [CI]) for future fractures in women with rib fracture history versus women with no fracture history were 5.4 (4.8–6.1) at the rib, 2.1 (1.7–2.6) at the spine, and 1.4 (1.1–1.7) at the wrist, and not significant for forearm or hip fractures. Future fracture risk was at least doubled in women with a rib fracture history in all ages: ARR (95% CI) 3.4 (2.8–4.0) for ages 50–59, 2.5 (2.1–3.0) for ages 60–69, 2.0 (1.7–2.3) for ages 70–79, and 2.0 (1.6–2.6) for ages >80. Conclusions Rib fracture, the second most common clinical fracture in women (after wrist fracture), predicted future fractures of the rib, wrist, and spine at all ages. Women presenting with rib fractures should be evaluated for appropriate management to prevent future fractures. PMID:21904951

Beyond Bevacizumab: An Outlook to New Anti-Angiogenics for the Treatment of Ovarian Cancer.

PubMed

Mahner, Sven; Woelber, Linn; Mueller, Volkmar; Witzel, Isabell; Prieske, Katharina; Grimm, Donata; Keller-V Amsberg, Gunhild; Trillsch, Fabian

2015-01-01

In addition to the monoclonal vascular endothelial growth factor (VEGF) antibody bevacizumab, several alternative anti-angiogenic treatment strategies for ovarian cancer patients have been evaluated in clinical trials. Apart from targeting extracellular receptors by the antibody aflibercept or the peptibody trebananib, the multikinase inhibitors pazopanib, nintedanib, cediranib, sunitinib, and sorafenib were developed to interfere with VEGF receptors and multiple additional intracellular pathways. Nintedanib and pazopanib significantly improved progression-free survival in two positive phase III trials for first-line therapy. A reliable effect on overall survival could, however, not be observed for any anti-angiogenic first-line therapies so far. In terms of recurrent disease, two positive phase III trials revealed that trebananib and cediranib are effective anti-angiogenic agents for this indication. Patient selection and biomarker guided prediction of response seems to be a central aspect for future studies. Combining anti-angiogenics with other targeted therapies to possibly spare chemotherapy in certain constellations represents another very interesting future perspective for clinical trials. This short review gives an overview of current clinical trials for anti-angiogenic treatment strategies beyond bevacizumab. In this context, possible future perspectives combining anti-angiogenics with other targeted therapies and the need for specific biomarkers predicting response are elucidated.

Predictors of future success in otolaryngology residency applicants.

PubMed

Chole, Richard A; Ogden, M Allison

2012-08-01

To evaluate the information available about otolaryngology residency applicants for factors that may predict future success as an otolaryngologist. Retrospective review of residency applications; survey of resident graduates and otolaryngology clinical faculty. Otolaryngology residency program. Otolaryngology program graduates from 2001 to 2010 and current clinical faculty from Barnes-Jewish Hospital/Washington University School of Medicine. Overall ratings of the otolaryngology graduates by clinical faculty (on a 5-point scale) were compared with the resident application attributes that might predict success. The application factors studied are United States Medical Licensing Examination part 1 score, Alpha Omega Alpha Honor Medical Society election, medical school grades, letter of recommendation, rank of the medical school, extracurricular activities, residency interview, experience with acting intern, and extracurricular activities. Forty-six graduates were included in the study. The overall faculty rating of the residents showed good interrater reliability. The objective factors, letters of recommendation, experience as an acting intern, and musical excellence showed no correlation with higher faculty rating. Rank of the medical school and faculty interview weakly correlated with faculty rating. Having excelled in a team sport correlated with higher faculty rating. Many of the application factors typically used during otolaryngology residency candidate selection may not be predictive of future capabilities as a clinician. Prior excellence in a team sport may suggest continued success in the health care team.

Dual-task testing to predict falls in community-dwelling older adults: a systematic review.

PubMed

Muir-Hunter, S W; Wittwer, J E

2016-03-01

Cognitive impairment increases fall risk in older adults. Dual-task testing is an accepted way to assess the interaction between cognition and mobility; however, there is a lack of evidence-based recommendations for dual-task testing to evaluate fall risk in clinical practice. To evaluate the association between dual-task testing protocols and future fall risk, and to identify the specific dual-task test protocols associated with elevated risk. MEDLINE, Pubmed and EMBASE electronic databases were searched from January 1988 to September 2013. Two independent raters identified prospective cohort studies (duration of at least 1 year) of dual-task assessment in community-dwelling participants aged ≥60 years, with 'falls' as the primary outcome. Methodological quality was scored independently by two raters using a published checklist of criteria for evaluating threats to the validity of observational studies. Deterioration in gait during dual-task testing compared with single-task performance was associated with increased fall risk. Shortcomings within the literature significantly limit knowledge translation of dual-task gait protocols into clinical practice. There is a paucity of prospective studies on the association of dual-task gait assessment with fall risk. Changes in gait under dual-task testing are associated with future fall risk, and this association is stronger than that for single-task conditions. Limitations in the available literature preclude development of detailed recommendations for dual-task gait testing procedures in clinical practice to identify and stratify fall risk in older adults. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Development and Validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment Item Banks.

PubMed

Forrest, Christopher B; Meltzer, Lisa J; Marcus, Carole L; de la Motte, Anna; Kratchman, Amy; Buysse, Daniel J; Pilkonis, Paul A; Becker, Brandon D; Bevans, Katherine B

2018-03-13

To develop and evaluate the measurement properties of child-report and parent-proxy versions of the PROMIS ® Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. A national sample of 1,104 children (8-17 years-old) and 1,477 parents of children 5-17 years-old was recruited from an internet panel to evaluate the psychometric properties of 43 sleep health items. A convenience sample of children and parents recruited from a pediatric sleep clinic was obtained to provide evidence of the measures' validity; polysomnography data were collected from a subgroup of these children. Factor analyses suggested two dimensions: sleep disturbance and daytime sleep-related impairment. The final item banks included 15 items for Sleep Disturbance and 13 for Sleep-Related Impairment. Items were calibrated using the graded response model from item response theory. Of the 28 items, 16 are included in the parallel PROMIS adult sleep health measures. Reliability of the measures exceeded 0.90. Validity was supported by correlations with existing measures of pediatric sleep health and higher sleep disturbance and sleep-related impairment scores for children with sleep problems and those with chronic and neurodevelopmental disorders. The sleep health measures were not correlated with results from polysomnography. The PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks provide subjective assessments of a child's difficulties falling and staying asleep as well as daytime sleepiness and its impact on functioning. They may prove useful in the future for clinical research and practice. Future research should evaluate their responsiveness to clinical change in diverse patient populations.

[Cannabis and cannabinoids. Possibilities of their therapeutic use].

PubMed

Heim, M E

1982-03-04

Newer aspects of therapeutic potentials of cannabis and cannabinoids are reviewed. The major active constituent of cannabis sativa, delta-9-tetrahydrocannabinol and synthetic cannabinoids are evaluated in several clinical trials on their antiemetic efficacy in cancer chemotherapy induced vomiting. 80% of patients refractory to standard antiemetic treatment could be improved with the synthetic cannabinoid levonantradol. Other therapeutic effects, which are presently investigated in clinical trials are analgesia, antispasticity, anticonvulsion and the reduction of intraocular pressure in glaucoma. The future goal of cannabinoid research is the separation between specific pharmacologic activities and undesirable psychotropic effects.

Vitamin K status in chronic kidney disease.

PubMed

McCabe, Kristin M; Adams, Michael A; Holden, Rachel M

2013-11-07

The purpose of this review is to summarize the research to date on vitamin K status in chronic kidney disease (CKD). This review includes a summary of the data available on vitamin K status in patients across the spectrum of CKD as well as the link between vitamin K deficiency in CKD and bone dynamics, including mineralization and demineralization, as well as ectopic mineralization. It also describes two current clinical trials that are underway evaluating vitamin K treatment in CKD patients. These data may inform future clinical practice in this population.

Depression and prospection.

PubMed

Roepke, Ann Marie; Seligman, Martin E P

2016-03-01

Prospection, the mental representation of possible futures, is usually adaptive. When it goes awry, however, it disrupts emotion and motivation. A negative view of the future is typically seen as one symptom of depression, but we suggest that such negative prospection is the core causal element of depression. Here, we describe the empirical evidence supporting this framework, and we explore the implications for clinical interventions. We integrate several literatures: Using the database PsycInfo, we retrieved empirical studies with the keywords prospection, prediction, expectation, pessimism, mental simulation, future-thinking, future-directed thinking, foresight, and/or mental time travel, in conjunction with depression, depressed, or depressive. Three kinds of faulty prospection, taken together, could drive depression: Poor generation of possible futures, poor evaluation of possible futures, and negative beliefs about the future. Depressed mood and poor functioning, in turn, may maintain faulty prospection and feed a vicious cycle. Future-oriented treatment strategies drawn from cognitive-behavioural therapy help to fix poor prospection, and they deserve to be developed further. Prospection-based techniques may lead to transdiagnostic treatment strategies for depression and other disorders. © 2015 The British Psychological Society.

Facilitating comparative effectiveness research in cancer genomics: evaluating stakeholder perceptions of the engagement process

PubMed Central

Deverka, Patricia A; Lavallee, Danielle C; Desai, Priyanka J; Armstrong, Joanne; Gorman, Mark; Hole-Curry, Leah; O’Leary, James; Ruffner, BW; Watkins, John; Veenstra, David L; Baker, Laurence H; Unger, Joseph M; Ramsey, Scott D

2013-01-01

Aims The Center for Comparative Effectiveness Research in Cancer Genomics completed a 2-year stakeholder-guided process for the prioritization of genomic tests for comparative effectiveness research studies. We sought to evaluate the effectiveness of engagement procedures in achieving project goals and to identify opportunities for future improvements. Materials & methods The evaluation included an online questionnaire, one-on-one telephone interviews and facilitated discussion. Responses to the online questionnaire were tabulated for descriptive purposes, while transcripts from key informant interviews were analyzed using a directed content analysis approach. Results A total of 11 out of 13 stakeholders completed both the online questionnaire and interview process, while nine participated in the facilitated discussion. Eighty-nine percent of questionnaire items received overall ratings of agree or strongly agree; 11% of responses were rated as neutral with the exception of a single rating of disagreement with an item regarding the clarity of how stakeholder input was incorporated into project decisions. Recommendations for future improvement included developing standard recruitment practices, role descriptions and processes for improved communication with clinical and comparative effectiveness research investigators. Conclusions Evaluation of the stakeholder engagement process provided constructive feedback for future improvements and should be routinely conducted to ensure maximal effectiveness of stakeholder involvement. PMID:23459832

Do Orthopaedic Oncologists Agree on the Diagnosis and Treatment of Cartilage Tumors of the Appendicular Skeleton?

PubMed

Zamora, Tomas; Urrutia, Julio; Schweitzer, Daniel; Amenabar, Pedro Pablo; Botello, Eduardo

2017-09-01

Distinguishing a benign enchondroma from a low-grade chondrosarcoma is a common diagnostic challenge for orthopaedic oncologists. Low interrater agreement has been observed for the diagnosis of cartilaginous neoplasms among radiologists and pathologists, but, to our knowledge, no study has evaluated inter- and intraobserver agreement among orthopaedic oncologists grading these lesions using initial clinical and imaging information. Determining such agreement is important since it reflects the certainty in the diagnosis by orthopaedic oncologists. Agreement also is important as it will guide future treatment and prognosis, considering that there is no gold standard for diagnosis of these lesions. (1) to determine inter- and intraobserver agreement among a multinational panel of expert orthopaedic oncologists in diagnosing cartilaginous neoplasms based on their assessment of clinical symptoms and imaging at diagnosis. (2) To describe the most important clinical and imaging features that experts use during the initial diagnostic process. (3) To determine interobserver agreement for proposed initial treatment strategies for cartilaginous neoplasms by this panel of evaluators. Thirty-nine patients with intramedullary cartilaginous neoplasms of the appendicular skeleton of various histopathologic grades were selected and classified as having benign, low-grade malignant, or intermediate- or high-grade malignant neoplasms by 10 experienced orthopaedic oncologists based on clinical and imaging information. Additionally, they chose the three most important clinical or imaging features for the diagnosis of these neoplasms, and they proposed a treatment strategy for each patient. The Kappa coefficient (κ) was used to determine inter- and intraobserver agreement. Inter- and intraobserver agreements were only fair to good, κ = 0.44(95% CI, 0.41-0.48) and κ = 0.62 (95% CI, 0.52-0.72), respectively. The three factors most frequently identified as helpful in making the diagnosis by our panel were cortical involvement in 65% of evaluations (253/390), neoplasm size in 51% (198/390), and pain in 50% (194/390). The interobserver agreement for the proposed initial treatment strategy after diagnosis was poor (κ = 0.21; 95% CI, 0.18-0.24). This study showed barely fair interobserver and fair to good intraobserver agreement for grading of intramedullary cartilaginous neoplasms by orthopaedic oncologists using initial clinical and imaging findings. These results reflect the insufficient guidance interpreting clinical and imaging features, and the limitations of the systems we use today when making these diagnoses. In the same way, they generate concern for the implications that this may have on different treatment strategies and the future prognosis of our patients. Future studies should build on these observations and focus on clarifying our criteria of diagnosis so that treatment recommendations are standardized regardless of the treating institution or oncologist. Level III, diagnostic study.

Ultrasound and MRI of nerves for monitoring disease activity and treatment effects in chronic dysimmune neuropathies - Current concepts and future directions.

PubMed

Décard, Bernhard F; Pham, Mirko; Grimm, Alexander

2018-01-01

New imaging modalities like high-resolution-ultrasound (HRUS) and MR-Neurography (MRN) are increasingly used for the evaluation of the peripheral nervous system. The increasing knowledge on morphological changes observed in different neuropathies has led to a better understanding of underlying pathophysiological processes. The diagnosis of acquired chronic dysimmune neuropathies (CDN) like chronic inflammatory demyelinating polyneuropathy (CIDP), Lewis-Sumner Syndrome (LSS) or multifocal motor neuropathy (MMN) can be challenging. The current diagnostic criteria and outcome parameters are mainly based on clinical and electrophysiological parameters. Especially in CDN cases with atypical presentation or during early disease stages, the diagnostic accuracy is low and standardized protocols for the evaluation of disease activity and treatment response are lacking. The establishment of combined diagnostic criteria for CDN including imaging modalities could help to improve the diagnostic accuracy, allow a better differentiation of subtypes and facilitate the follow-up of disease course. The appropriate selection of eligible patients and sensitive monitoring of treatment response is mandatory future in treatment trials. In this article, we briefly summarize the clinical presentations and pathophysiological concepts of different CDN like CIDP, LSS and MMN. Furthermore, this review focuses on the diagnostic value of HRUS/MRN and its potential role for the monitoring of disease activity. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Creativity in clinical communication: from communication skills to skilled communication.

PubMed

Salmon, Peter; Young, Bridget

2011-03-01

Medical Education 2011: 45: 217-226 Objectives  The view that training in communication skills produces skilled communication is sometimes criticised by those who argue that communication is individual and intuitive. We therefore examine the validity of the concept of communication as a skill and identify alternative principles to underpin future development of this field. Methods  We critically examine research evidence about the nature of clinical communication, and draw from theory and evidence concerning education and evaluation, particularly in creative disciplines. Results  Skilled communication cannot be fully described using the concept of communication skills. Attempts to do so risk constraining and distorting pedagogical development in communication. Current education practice often masks the difficulties with the concept by introducing subjectivity into the definition and assessment of skills. As all clinical situations differ to some extent, clinical communication is inherently creative. Because it is rarely possible to attribute specific effects to specific elements of communication, communication needs to be taught and evaluated holistically. Conclusions  For communication teaching to be pedagogically and clinically valid in supporting the inherent creativity of clinical communication, it will need to draw from education theory and practice that have been developed in explicitly creative disciplines. © Blackwell Publishing Ltd 2011.

The Correction of Myopia Evaluation Trial: lessons from the study design.

PubMed

Hyman, L; Gwiazda, J

2004-01-01

The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.

Generation of clinical-grade human induced pluripotent stem cells in Xeno-free conditions.

PubMed

Wang, Juan; Hao, Jie; Bai, Donghui; Gu, Qi; Han, Weifang; Wang, Lei; Tan, Yuanqing; Li, Xia; Xue, Ke; Han, Pencheng; Liu, Zhengxin; Jia, Yundan; Wu, Jun; Liu, Lei; Wang, Liu; Li, Wei; Liu, Zhonghua; Zhou, Qi

2015-11-12

Human induced pluripotent stem cells (hiPSCs) are considered as one of the most promising seed cell sources in regenerative medicine. Now hiPSC-based clinical trials are underway. To ensure clinical safety, cells used in clinical trials or therapies should be generated under GMP conditions, and with Xeno-free culture media to avoid possible side effects like immune rejection that induced by the Xeno reagents. However, up to now there are no reports for hiPSC lines developed completely under GMP conditions using Xeno-free reagents. Clinical-grade human foreskin fibroblast (HFF) cells used as feeder cells and parental cells of the clinical-grade hiPSCs were isolated from human foreskin tissues and cultured in Xeno-free media. Clinical-grade hiPSCs were derived by integration-free Sendai virus-based reprogramming kit in Xeno-free pluriton™ reprogramming medium or X medium. Neural cells and cardiomyocytes differentiation were conducted following a series of spatial and temporal specific signals induction according to the corresponding lineage development signals. Biological safety evaluation of the clinical-grade HFF cells and hiPSCs were conducted following the guidance of the "Pharmacopoeia of the People's Republic of China, Edition 2010, Volume III". We have successfully derived several integration-free clinical-grade hiPSC lines under GMP-controlled conditions and with Xeno-free reagents culture media in line with the current guidance of international and national evaluation criteria. As for the source of hiPSCs and feeder cells, biological safety evaluation of the HFF cells have been strictly reviewed by the National Institutes for Food and Drug Control (NIFDC). The hiPSC lines are pluripotent and have passed the safety evaluation. Moreover, one of the randomly selected hiPSC lines was capable of differentiating into functional neural cells and cardiomyocytes in Xeno-free culture media. The clinical-grade hiPSC lines therefore could be valuable sources for future hiPSC-based clinical trials or therapies and for drug screening.

Strength and balance training for adults with peripheral neuropathy and high risk of fall: current evidence and implications for future research.

PubMed

Tofthagen, Cindy; Visovsky, Constance; Berry, Donna L

2012-09-01

To evaluate the evidence for strength- and balance-training programs in patients at high risk for falls, discuss how results of existing studies might guide clinical practice, and discuss directions for additional research. A search of PubMed and CINAHL® databases was conducted in June 2011 using the terms strength, balance training, falls, elderly, and neuropathy. Only clinical trials conducted using specific strength- or balance-training exercises that included community-dwelling adults and examined falls, fall risk, balance, and/or strength as outcome measures were included in this review. One matched case-control study and two randomized, controlled studies evaluating strength and balance training in patients with diabetes-related peripheral neuropathy were identified. Eleven studies evaluating strength and balance programs in community-dwelling adults at high risk for falls were identified. The findings from the reviewed studies provide substantial evidence to support the use of strength and balance training for older adults at risk for falls, and detail early evidence to support strength and balance training for individuals with peripheral neuropathy. The evidence demonstrates that strength and balance training is safe and effective at reducing falls and improving lower extremity strength and balance in adults aged 50 years and older at high risk for falls, including patients with diabetic peripheral neuropathy. Future studies should evaluate the effects of strength and balance training in patients with cancer, particularly individuals with chemotherapy-induced peripheral neuropathy.

Contemporary challenges for specialist nursing in interstitial lung disease

PubMed Central

Russell, Anne Marie; Olive, Sandra; Lines, Sarah; Murphy, Anna; Hocking, Julie; Newell, Karen; Morris, Helen; Harris, Emma; Dixon, Catherine; Agnew, Sarah; Burge, Geraldine

2018-01-01

The role of clinical nurse specialists (CNSs) in interstitial lung disease (ILD) is evolving in response to clinical guidelines and the growth of clinical research. The role is well established in the UK, although more ILD posts are needed to ensure supply meets clinical demand. This phenomenon is also happening across Europe. An appreciation of the similarities and differences between CNS and advanced nurse practitioners is important given the challenges in defining, developing and supporting this nursing specialisation. Globally, different models exist. In some countries charitable organisations take a leading role in supporting patients. Many European centres look to the National Institute for Health and Care Excellence guidelines and quality standards as a template to develop and evaluate the role of the ILD CNS. We present a UK perspective in the context of a government subsidised healthcare system to promote professional discussion and debate regarding the future of nursing practice in the ILD specialty. Key points ILDs are often complex and associated with significant mortality, morbidity and co-morbid conditions that require a technical healthcare skill set There is worldwide shortage of nurses, low retention rates and retirement of many skilled nurses Collaboration across the ILD interdisciplinary community is needed to safeguard the future of our professions and high-quality patient care The ILD interdisciplinary and nurse network has identified key priorities to help secure the future of the ILD clinical and academic nurse specialism Educational aims To explain the similarities and differences between clinical nurse specialists (CNSs) and advanced nurse practitioners (ANPs) in the context of ILD specialism To review contemporary nursing specialism in the UK’s government subsidised healthcare system To stimulate discussion and debate across the European/international respiratory community regarding the clinical and academic development of the ILD CNS To identify key priorities that will support collaboration across the ILD interdisciplinary workforce in clinical practice and research PMID:29515666

Contemporary challenges for specialist nursing in interstitial lung disease.

PubMed

Russell, Anne Marie; Olive, Sandra; Lines, Sarah; Murphy, Anna; Hocking, Julie; Newell, Karen; Morris, Helen; Harris, Emma; Dixon, Catherine; Agnew, Sarah; Burge, Geraldine

2018-03-01

The role of clinical nurse specialists (CNSs) in interstitial lung disease (ILD) is evolving in response to clinical guidelines and the growth of clinical research. The role is well established in the UK, although more ILD posts are needed to ensure supply meets clinical demand. This phenomenon is also happening across Europe. An appreciation of the similarities and differences between CNS and advanced nurse practitioners is important given the challenges in defining, developing and supporting this nursing specialisation. Globally, different models exist. In some countries charitable organisations take a leading role in supporting patients. Many European centres look to the National Institute for Health and Care Excellence guidelines and quality standards as a template to develop and evaluate the role of the ILD CNS. We present a UK perspective in the context of a government subsidised healthcare system to promote professional discussion and debate regarding the future of nursing practice in the ILD specialty. ILDs are often complex and associated with significant mortality, morbidity and co-morbid conditions that require a technical healthcare skill setThere is worldwide shortage of nurses, low retention rates and retirement of many skilled nursesCollaboration across the ILD interdisciplinary community is needed to safeguard the future of our professions and high-quality patient careThe ILD interdisciplinary and nurse network has identified key priorities to help secure the future of the ILD clinical and academic nurse specialism. To explain the similarities and differences between clinical nurse specialists (CNSs) and advanced nurse practitioners (ANPs) in the context of ILD specialismTo review contemporary nursing specialism in the UK's government subsidised healthcare systemTo stimulate discussion and debate across the European/international respiratory community regarding the clinical and academic development of the ILD CNSTo identify key priorities that will support collaboration across the ILD interdisciplinary workforce in clinical practice and research.

The Importance of Clinical Phenotype in Understanding and Preventing Spontaneous Preterm Birth.

PubMed

Esplin, M Sean

2016-02-01

Spontaneous preterm birth (SPTB) is a well-known cause of maternal and neonatal morbidity. The search for the underlying pathways, documentation of the genetic causes, and identification of markers of spontaneous PTB have been marginally successful due to the fact that it is highly complex, with numerous processes that lead to a final common pathway. There is a great need for a comprehensive, consistent, and uniform classification system, which will be useful in identifying mechanisms, assigning prognosis, aiding in clinical management, and can identify areas of interest for intervention and future study. Effective classification systems must overcome obstacles including the lack of widely accepted definitions and uncertainty about inclusion of classifying features (e.g., presentation at delivery and multiple gestations) and levels of detail of these features. The optimal classification system should be based on the clinical phenotype, including characteristics of the mother, fetus, placenta, and the presentation for delivery. We present a proposed phenotyping system for spontaneous PTB. Future classification systems must establish a universally accepted set of definitions and a standardized clinical workup for all PTBs including the minimum clinical data to be collected and the laboratory and pathologic evaluation that should be completed. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Comprehensive Characterization of Reference Standard Lots of HIV-1 Subtype C Gp120 Proteins for Clinical Trials in Southern African Regions

PubMed Central

Wang, Zihao; Lorin, Clarisse; Koutsoukos, Marguerite; Franco, David; Bayat, Babak; Zhang, Ying; Carfi, Andrea; Barnett, Susan W.; Porter, Frederick

2016-01-01

Two HIV-1 subtype C gp120 protein candidates were the selected antigens for several experimental vaccine regimens now under evaluation in HVTN 100 Phase I/II clinical trial aiming to support the start of the HVTN 702 Phase IIb/III trial in southern Africa, which is designed to confirm and extend the partial protection seen against HIV-1 infection in the RV144 Thai trial. Here, we report the comprehensive physicochemical characterization of the gp120 reference materials that are representative of the clinical trial materials. Gp120 proteins were stably expressed in Chinese Hamster Ovary (CHO) cells and subsequently purified and formulated. A panel of analytical techniques was used to characterize the physicochemical properties of the two protein molecules. When formulated in the AS01 Adjuvant System, the bivalent subtype C gp120 antigens elicited 1086.C- and TV1.C-specific binding antibody and CD4+ T cell responses in mice. All the characteristics were highly representative of the Clinical Trial Materials (CTM). Data from this report demonstrate the immunogenicity of the gp120 antigens, provide comprehensive characterization of the molecules, set the benchmark for assessment of current and future CTM lots, and lay the physicochemical groundwork for interpretation of future clinical trial data. PMID:27187483

Pharmacogenetics and pharmacogenomics in psoriasis treatment: current challenges and future prospects.

PubMed

Sutherland, Alison; Power, Rebecca J; Rahman, Proton; O'Rielly, Darren D

2016-08-01

Topical, systemic, oral disease modifying, and biologic agents are part of the armamentarium to manage psoriatic disease. The choice of therapy depends upon disease severity, relevant co-morbidities and patient preference. There is great variability in patient response with these agents, and there is still no clear method of selecting the preferred therapeutic agent for efficacy or lack of adverse events. This article will review the pharmacogenetic and pharmacogenomic targets that are currently known with respect to psoriasis vulgaris, and the most frequent co-morbidity of psoriasis, psoriatic arthritis. Presently, no clinically actionable biomarker exists for any therapeutic agent used to treat psoriasis or psoriatic arthritis. The lack of validated outcome measures and conflicting results of open-label studies conducted may be attributed to a multitude of issues that confound discovery. Consequently, studies have been underpowered to identify genes or genetic variants worth translating to clinical practice. In order to achieve a pharmacogenetic/pharmacogenomic signature, improvements in study design of future investigations are required, including carefully designed prospective studies. It is imperative to combine known clinical, serological, and molecular markers with consistent outcomes and an adequate health economic evaluation before they can be adopted widely in clinical practice.

On individual differences in person perception: raters' personality traits relate to their psychopathy checklist-revised scoring tendencies.

PubMed

Miller, Audrey K; Rufino, Katrina A; Boccaccini, Marcus T; Jackson, Rebecca L; Murrie, Daniel C

2011-06-01

This study investigated raters' personality traits in relation to scores they assigned to offenders using the Psychopathy Checklist-Revised (PCL-R). A total of 22 participants, including graduate students and faculty members in clinical psychology programs, completed a PCL-R training session, independently scored four criminal offenders using the PCL-R, and completed a comprehensive measure of their own personality traits. A priori hypotheses specified that raters' personality traits, and their similarity to psychopathy characteristics, would relate to raters' PCL-R scoring tendencies. As hypothesized, some raters assigned consistently higher scores on the PCL-R than others, especially on PCL-R Facets 1 and 2. Also as hypothesized, raters' scoring tendencies related to their own personality traits (e.g., higher rater Agreeableness was associated with lower PCL-R Interpersonal facet scoring). Overall, findings underscore the need for future research to examine the role of evaluator characteristics on evaluation results and the need for clinical training to address evaluators' personality influences on their ostensibly objective evaluations.

Exploring for the optimal structural design for the 3D-printing technology for cranial reconstruction: a biomechanical and histological study comparison of solid vs. porous structure.

PubMed

Lim, Jun Young; Kim, Namhyun; Park, Jong-Chul; Yoo, Sun K; Shin, Dong Ah; Shim, Kyu-Won

2017-09-01

Cranioplasty for recovering skull defects carries the risk for a number of complications. Various materials are used, including autologous bone graft, metallic materials, and non-metallic materials, each of which has advantages and disadvantages. If the use of autologous bone is not feasible, those artificial materials also have constraints in the case of complex anatomy and/or irregular defects. This study used metal 3D-printing technology to overcome these existing drawbacks and analyze the clinical and mechanical performance requirements. To find an optimal structure that satisfied the structural and mechanical stability requirements, we evaluated biomechanical stability using finite element analysis (FEA) and mechanical testing. To ensure clinical applicability, the model was subjected to histological evaluation. Each specimen was implanted in the femur of a rabbit and was evaluated using histological measurements and push-out test. We believe that our data will provide the basis for future applications of a variety of unit structures and further clinical trials and research, as well as the direction for the study of other patient-specific implants.

An Official American Thoracic Society Clinical Practice Guideline: Classification, Evaluation, and Management of Childhood Interstitial Lung Disease in Infancy

PubMed Central

Kurland, Geoffrey; Deterding, Robin R.; Hagood, James S.; Young, Lisa R.; Brody, Alan S.; Castile, Robert G.; Dell, Sharon; Fan, Leland L.; Hamvas, Aaron; Hilman, Bettina C.; Langston, Claire; Nogee, Lawrence M.; Redding, Gregory J.

2013-01-01

Background: There is growing recognition and understanding of the entities that cause interstitial lung disease (ILD) in infants. These entities are distinct from those that cause ILD in older children and adults. Methods: A multidisciplinary panel was convened to develop evidence-based guidelines on the classification, diagnosis, and management of ILD in children, focusing on neonates and infants under 2 years of age. Recommendations were formulated using a systematic approach. Outcomes considered important included the accuracy of the diagnostic evaluation, complications of delayed or incorrect diagnosis, psychosocial complications affecting the patient’s or family’s quality of life, and death. Results: No controlled clinical trials were identified. Therefore, observational evidence and clinical experience informed judgments. These guidelines: (1) describe the clinical characteristics of neonates and infants (<2 yr of age) with diffuse lung disease (DLD); (2) list the common causes of DLD that should be eliminated during the evaluation of neonates and infants with DLD; (3) recommend methods for further clinical investigation of the remaining infants, who are regarded as having “childhood ILD syndrome”; (4) describe a new pathologic classification scheme of DLD in infants; (5) outline supportive and continuing care; and (6) suggest areas for future research. Conclusions: After common causes of DLD are excluded, neonates and infants with childhood ILD syndrome should be evaluated by a knowledgeable subspecialist. The evaluation may include echocardiography, controlled ventilation high-resolution computed tomography, infant pulmonary function testing, bronchoscopy with bronchoalveolar lavage, genetic testing, and/or lung biopsy. Preventive care, family education, and support are essential. PMID:23905526

Collaborative learning in pre-clinical dental hygiene education.

PubMed

Mueller-Joseph, Laura J; Nappo-Dattoma, Luisa

2013-04-01

Dental hygiene education continues to move beyond mastery of content material and skill development to learning concepts that promote critical-thinking and problem-solving skills. The purpose of this research was to evaluate the effectiveness of collaborative learning and determine the growth in intellectual development of 54 first-year dental hygiene students. The control group used traditional pre-clinical teaching and the experimental group used collaborative pedagogy for instrument introduction. All students were subjected to a post-test evaluating their ability to apply the principles of instrumentation. Intellectual development was determined using pre- and post-tests based on the Perry Scheme of Intellectual Development. Student attitudes were assessed using daily Classroom Assessment Activities and an end-of-semester departmental course evaluation. Findings indicated no significant difference between collaborative learning and traditional learning in achieving pre-clinical competence as evidenced by the students' ability to apply the principles of instrumentation. Advancement in intellectual development did not differ significantly between groups. Value added benefits of a collaborative learning environment as identified by the evaluation of student attitudes included decreased student reliance on authority, recognition of peers as legitimate sources of learning and increased self-confidence. A significant difference in student responses to daily classroom assessments was evident on the 5 days a collaborative learning environment was employed. Dental hygiene students involved in a pre-clinical collaborative learning environment are more responsible for their own learning and tend to have a more positive attitude toward the subject matter. Future studies evaluating collaborative learning in clinical dental hygiene education need to investigate the cost/benefit ratio of the value added outcomes of collaborative learning.

Nailfold capillaroscopy for prediction of novel future severe organ involvement in systemic sclerosis.

PubMed

Smith, Vanessa; Riccieri, Valeria; Pizzorni, Carmen; Decuman, Saskia; Deschepper, Ellen; Bonroy, Carolien; Sulli, Alberto; Piette, Yves; De Keyser, Filip; Cutolo, Maurizio

2013-12-01

Assessment of associations of nailfold videocapillaroscopy (NVC) scleroderma (systemic sclerosis; SSc) ("early," "active," and "late") with novel future severe clinical involvement in 2 independent cohorts. Sixty-six consecutive Belgian and 82 Italian patients with SSc underwent NVC at baseline. Images were blindly assessed and classified into normal, early, active, or late NVC pattern. Clinical evaluation was performed for 9 organ systems (general, peripheral vascular, skin, joint, muscle, gastrointestinal tract, lung, heart, and kidney) according to the Medsger disease severity scale (DSS) at baseline and in the future (18-24 months of followup). Severe clinical involvement was defined as category 2 to 4 per organ of the DSS. Logistic regression analysis (continuous NVC predictor variable) was performed. The OR to develop novel future severe organ involvement was stronger according to more severe NVC patterns and similar in both cohorts. In simple logistic regression analysis the OR in the Belgian/Italian cohort was 2.16 (95% CI 1.19-4.47, p = 0.010)/2.33 (95% CI 1.36-4.22, p = 0.002) for the early NVC SSc pattern, 4.68/5.42 for the active pattern, and 10.14/12.63 for the late pattern versus the normal pattern. In multiple logistic regression analysis, adjusting for disease duration, subset, and vasoactive medication, the OR was 2.99 (95% CI 1.31-8.82, p = 0.007)/1.88 (95% CI 1.00-3.71, p = 0.050) for the early NVC SSc pattern, 8.93/3.54 for the active pattern, and 26.69/6.66 for the late pattern versus the normal pattern. Capillaroscopy may be predictive of novel future severe organ involvement in SSc, as attested by 2 independent cohorts.

The effectiveness of toolkits as knowledge translation strategies for integrating evidence into clinical care: a systematic review

PubMed Central

Yamada, Janet; Shorkey, Allyson; Barwick, Melanie; Widger, Kimberley; Stevens, Bonnie J

2015-01-01

Objectives The aim of this systematic review was to evaluate the effectiveness of toolkits as a knowledge translation (KT) strategy for facilitating the implementation of evidence into clinical care. Toolkits include multiple resources for educating and/or facilitating behaviour change. Design Systematic review of the literature on toolkits. Methods A search was conducted on MEDLINE, EMBASE, PsycINFO and CINAHL. Studies were included if they evaluated the effectiveness of a toolkit to support the integration of evidence into clinical care, and if the KT goal(s) of the study were to inform, share knowledge, build awareness, change practice, change behaviour, and/or clinical outcomes in healthcare settings, inform policy, or to commercialise an innovation. Screening of studies, assessment of methodological quality and data extraction for the included studies were conducted by at least two reviewers. Results 39 relevant studies were included for full review; 8 were rated as moderate to strong methodologically with clinical outcomes that could be somewhat attributed to the toolkit. Three of the eight studies evaluated the toolkit as a single KT intervention, while five embedded the toolkit into a multistrategy intervention. Six of the eight toolkits were partially or mostly effective in changing clinical outcomes and six studies reported on implementation outcomes. The types of resources embedded within toolkits varied but included predominantly educational materials. Conclusions Future toolkits should be informed by high-quality evidence and theory, and should be evaluated using rigorous study designs to explain the factors underlying their effectiveness and successful implementation. PMID:25869686

Applying tattoo dye as a third-harmonic generation contrast agent for in vivo optical virtual biopsy of human skin

NASA Astrophysics Data System (ADS)

Tsai, Ming-Rung; Lin, Chen-Yu; Liao, Yi-Hua; Sun, Chi-Kuang

2013-02-01

Third-harmonic generation (THG) microscopy has been reported to provide intrinsic contrast in elastic fibers, cytoplasmic membrane, nucleus, actin filaments, lipid bodies, hemoglobin, and melanin in human skin. For advanced molecular imaging, exogenous contrast agents are developed for a higher structural or molecular specificity. We demonstrate the potential of the commonly adopted tattoo dye as a THG contrast agent for in vivo optical biopsy of human skin. Spectroscopy and microscopy experiments were performed on cultured cells with tattoo dyes, in tattooed mouse skin, and in tattooed human skin to demonstrate the THG enhancement effect. Compared with other absorbing dyes or nanoparticles used as exogenous THG contrast agents, tattoo dyes are widely adopted in human skin so that future clinical biocompatibility evaluation is relatively achievable. Combined with the demonstrated THG enhancement effect, tattoo dyes show their promise for future clinical imaging applications.

Medical beam monitor—Pre-clinical evaluation and future applications

NASA Astrophysics Data System (ADS)

Frais-Kölbl, Helmut; Griesmayer, Erich; Schreiner, Thomas; Georg, Dietmar; Pernegger, Heinz

2007-10-01

Future medical ion beam applications for cancer therapy which are based on scanning technology will require advanced beam diagnostics equipment. For a precise analysis of beam parameters we want to resolve time structures in the range of microseconds to nanoseconds. A prototype of an advanced beam monitor was developed by the University of Applied Sciences Wiener Neustadt and its research subsidiary Fotec in co-operation with CERN RD42, Ohio State University and the Jožef Stefan Institute in Ljubljana. The detector is based on polycrystalline Chemical Vapor Deposition (pCVD) diamond substrates and is equipped with readout electronics up to 2 GHz analog bandwidth. In this paper we present the design of the pCVD-detector system and results of tests performed in various particle accelerator based facilities. Measurements performed in clinical high energy photon beams agreed within 1.2% with results obtained by standard ionization chambers.

Neuroprotective Strategies after Neonatal Hypoxic Ischemic Encephalopathy

PubMed Central

Dixon, Brandon J.; Reis, Cesar; Ho, Wing Mann; Tang, Jiping; Zhang, John H.

2015-01-01

Neonatal hypoxic ischemic encephalopathy (HIE) is a devastating disease that primarily causes neuronal and white matter injury and is among the leading cause of death among infants. Currently there are no well-established treatments; thus, it is important to understand the pathophysiology of the disease and elucidate complications that are creating a gap between basic science and clinical translation. In the development of neuroprotective strategies and translation of experimental results in HIE, there are many limitations and challenges to master based on an appropriate study design, drug delivery properties, dosage, and use in neonates. We will identify understudied targets after HIE, as well as neuroprotective molecules that bring hope to future treatments such as melatonin, topiramate, xenon, interferon-beta, stem cell transplantation. This review will also discuss some of the most recent trials being conducted in the clinical setting and evaluate what directions are needed in the future. PMID:26389893

Economic evaluations of clinical pharmacist interventions on hospital inpatients: a systematic review of recent literature.

PubMed

Gallagher, James; McCarthy, Suzanne; Byrne, Stephen

2014-12-01

Clinical and cost-effectiveness evidence are needed to justify the existence or extension of routine clinical pharmacy services in hospital settings. Previous reviews have indicated that clinical pharmacist interventions are likely to have a positive economic impact on hospital budgets but highlighted issues relating to the quality of studies. The primary aim of this review was to feature economic evaluations of clinical pharmacy services which targeted hospital inpatients. The review focused on the current cost-effectiveness status of different services, in addition to evaluating the quality of individual studies. Results of this systematic review were compared with cost-effectiveness and quality related findings of reviews which considered earlier time frames and alternative settings. A systematic review of the literature included a review of the following databases: Academic Search Complete, Cochrane Library, EconLit, Embase Elsevier, NHS Economic Evaluation Database and PubMed. Only studies with an economic assessment of a clinical pharmacy service provided in a hospital setting were included. Data relating to the cost-effectiveness was extracted from eligible studies. Methodologies employed and overall quality of the studies was also reviewed. A grading system was applied to determine the quality of studies. Consolidated Health Economic Evaluation Reporting Standards statement was employed to determine which aspects of a high quality health economic study were employed. Twenty studies were deemed eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15 %) were deemed to be "good-quality" studies. No 'novel'clinical pharmacist intervention was identified during the course of this review. Clinical pharmacy interventions continue to provide cost savings. However, the standard of studies published has stagnated or even deteriorated in comparison with those included in previous reviews. Utilisation of published guidelines at initial stages of future studies may help improve the overall quality of studies.

Evaluation of a Theory-Driven E-Learning Intervention for Future Oral Healthcare Providers on Secondary Prevention of Disordered Eating Behaviors

ERIC Educational Resources Information Center

DeBate, Rita D.; Severson, Herbert H.; Cragun, Deborah L.; Gau, Jeff M.; Merrell, Laura K.; Bleck, Jennifer R.; Christiansen, Steve; Koerber, Anne; Tomar, Scott L.; Brown, Kelli R. McCormack; Tedesco, Lisa A.; Hendricson, William

2013-01-01

Oral healthcare providers have a clinical opportunity for early detection of disordered eating behaviors because they are often the first health professionals to observe overt oral and physical signs. Curricula regarding early recognition of this oral/systemic medical condition are limited in oral health educational programs. Web-based learning…

Modeling paradigms for medical diagnostic decision support: a survey and future directions.

PubMed

Wagholikar, Kavishwar B; Sundararajan, Vijayraghavan; Deshpande, Ashok W

2012-10-01

Use of computer based decision tools to aid clinical decision making, has been a primary goal of research in biomedical informatics. Research in the last five decades has led to the development of Medical Decision Support (MDS) applications using a variety of modeling techniques, for a diverse range of medical decision problems. This paper surveys literature on modeling techniques for diagnostic decision support, with a focus on decision accuracy. Trends and shortcomings of research in this area are discussed and future directions are provided. The authors suggest that-(i) Improvement in the accuracy of MDS application may be possible by modeling of vague and temporal data, research on inference algorithms, integration of patient information from diverse sources and improvement in gene profiling algorithms; (ii) MDS research would be facilitated by public release of de-identified medical datasets, and development of opensource data-mining tool kits; (iii) Comparative evaluations of different modeling techniques are required to understand characteristics of the techniques, which can guide developers in choice of technique for a particular medical decision problem; and (iv) Evaluations of MDS applications in clinical setting are necessary to foster physicians' utilization of these decision aids.

Adoption and correlates of Postgraduate Hospital Educational Environment Measure (PHEEM) in the evaluation of learning environments - A systematic review.

PubMed

Chan, Christopher Yi Wen; Sum, Min Yi; Lim, Wee Shiong; Chew, Nicholas Wuen Ming; Samarasekera, Dujeepa D; Sim, Kang

2016-12-01

The Postgraduate Hospital Educational Environment Measure (PHEEM) is a highly reliable and valid instrument to measure the educational environment during post graduate medical training. This review extends earlier reports by evaluating the extant adoption of PHEEM in various international clinical training sites, and its significant correlations in order to expand our understanding on the use of PHEEM and facilitate future applications and research. A systematic literature review was conducted on all articles between 2005 and October 2015 that adopted and reported data using the PHEEM. Overall 30 studies were included, encompassing data from 14 countries internationally. Notable differences in the PHEEM scores were found between different levels of training, disciplines, and clinical training sites. Common strengths and weaknesses in learning environments were observed and there were significant correlations between PHEEM scores and In-Training Exam (ITE) performance (positive correlation) and level of burnout (negative correlation), respectively. PHEEM is widely adopted in different learning settings, and is a useful tool to identify the strengths and weaknesses of an educational environment. Future research can examine other correlates of PHEEM and longitudinal changes in interventional studies.

Tissue Doppler and strain imaging: anything left in the echo-lab?

PubMed Central

Citro, Rodolfo; Bossone, Eduardo; Kuersten, Bettina; Gregorio, Giovanni; Salustri, Alessandro

2008-01-01

Medline research indicates that an increasing number of manuscripts have been published in the last decade claiming, the feasibility and the potential clinical role of tissue Doppler and strain/strain rate imaging. However, despite this amount of scientific evidence, these technologies are still confined to dedicated, high-tech, research-oriented echocardiography laboratories. In this review we have critically evaluated these techniques, analysing their physical principles, the technical problems related to their current clinical application, and the future perspectives. Finally, this review explores the reasons why these technologies are still defined "new technologies" and the impact of their implementation on the current clinical activity of an echocardiography laboratory. PMID:18973677

Evaluation and Management of Hepatic Encephalopathy: Current Status and Future Directions

PubMed Central

Suraweera, Duminda; Sundaram, Vinay; Saab, Sammy

2016-01-01

Hepatic encephalopathy is a spectrum of neurocognitive manifestations often seen in patients with liver injury or rarely in patients with portosystemic shunting without liver injury. It can be divided into minimal (covert) hepatic encephalopathy and overt hepatic encephalopathy, depending on the severity. Patients with hepatic encephalopathy have compromised clinical outcomes, decreased quality of life, and increased healthcare utilization, often resulting in a heavy financial and personal burden on caregivers. The diagnosis remains largely clinical, with the exclusion of possible other causes for the altered mental status. Current treatment strategies include nonabsorbable disaccharides and antibiotics. This review will focus on the diagnosis, management and clinical impact of hepatic encephalopathy. PMID:27377741

The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

PubMed

Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

2016-04-01

Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

CFD for evaluation and treatment planning of aneurysms: review of proposed clinical uses and their challenges.

PubMed

Chung, Bongjae; Cebral, Juan Raul

2015-01-01

Computational fluid dynamics (CFD) has been used for several years to identify mechanical risk factors associated with aneurysmal evolution and rupture as well as to understand flow characteristics before and after surgical treatments in order to help the clinical decision making process. We used the keywords, "CFD" and "aneurysms" to search recent publications since about 2000, and categorized them into (i) studies of rupture risk factors and (ii) investigations of pre- and post-evaluations of surgical treatment with devices like coils and flow diverters (FD). This search enables us to examine the current status of CFD as a clinical tool and to determine if CFD can potentially become an important part of the routine clinical practice for the evaluation and treatment of aneurysms in near future. According to previous reports, it has been argued that CFD has become a quite robust non-invasive tool for the evaluation of surgical devices, especially in the early stages of device design and it has also been applied successfully to the study of rupture risk assessment. However, we find that due to the large number of pre-processing inputs further efforts of validation and reproducibility of CFD with larger clinical datasets are still essential to identify standardized mechanical risk factors. As a result, we identify the following needs to have a robust CFD tool for clinical use: (i) more reliability tests through validation studies, (ii) analyses of larger generalized clinical datasets to find converging universal risk parameters, (iii) fluid structure interaction (FSI) analyses to better understand the detailed vascular remodeling processes associated with aneurysm growth, evolution and rupture, and (iv) better coordinated and organized communications and collaborations between engineers and clinicians.

Cerebrovascular accident patients: an interdisciplinary/multidisciplinary audit.

PubMed

Penman, G M; Wojnar-Horton, S A; Bebee, R

1991-01-01

To develop appropriate standards to assess the intervention with cerebrovascular accident (CVA) patients by allied health professionals; to establish baseline data with which subsequent information collected could be compared. Retrospective criteria auditing of hospital files was undertaken to evaluate whether the allied health professionals were meeting the expected clinical standards for patients admitted with a diagnosis of CVA. Written documentation in hospital files did not meet expected standards in all criteria and varied between professions. The data obtained provided a baseline against which future results could be measured. It was expected that subsequent evaluations would provide improved results. All departments agreed that meeting clinical standards was important and it was agreed to repeat the audit in one year and to include some outcome standards using patients' perceptions of service provision.

Specialized inpatient treatment of adult anorexia nervosa: effectiveness and clinical significance of changes.

PubMed

Schlegl, Sandra; Quadflieg, Norbert; Löwe, Bernd; Cuntz, Ulrich; Voderholzer, Ulrich

2014-09-06

Previous studies have predominantly evaluated the effectiveness of inpatient treatment for anorexia nervosa at the group level. The aim of this study was to evaluate treatment outcomes at an individual level based on the clinical significance of improvement. Patients' treatment outcomes were classified into four groups: deteriorated, unchanged, reliably improved and clinically significantly improved. Furthermore, the study set out to explore predictors of clinically significant changes in eating disorder psychopathology. A total of 435 inpatients were assessed at admission and at discharge on the following measures: body-mass-index, eating disorder symptoms, general psychopathology, depression and motivation for change. 20.0-32.0% of patients showed reliable changes and 34.1-55.3% showed clinically significant changes in the various outcome measures. Between 23.0% and 34.5% remained unchanged and between 1.7% and 3.0% deteriorated. Motivation for change and depressive symptoms were identified as positive predictors of clinically significant changes in eating disorder psychopathology, whereas body dissatisfaction, impulse regulation, social insecurity and education were negative predictors. Despite high rates of reliable and clinically significant changes following intensive inpatient treatment, about one third of anorexia nervosa patients showed no significant response to treatment. Future studies should focus on the identification of non-responders as well as on the development of treatment strategies for these patients.

A future-proof architecture for telemedicine using loose-coupled modules and HL7 FHIR.

PubMed

Gøeg, Kirstine Rosenbeck; Rasmussen, Rune Kongsgaard; Jensen, Lasse; Wollesen, Christian Møller; Larsen, Søren; Pape-Haugaard, Louise Bilenberg

2018-07-01

Most telemedicine solutions are proprietary and disease specific which cause a heterogeneous and silo-oriented system landscape with limited interoperability. Solving the interoperability problem would require a strong focus on data integration and standardization in telemedicine infrastructures. Our objective was to suggest a future-proof architecture, that consisted of small loose-coupled modules to allow flexible integration with new and existing services, and the use of international standards to allow high re-usability of modules, and interoperability in the health IT landscape. We identified core features of our future-proof architecture as the following (1) To provide extended functionality the system should be designed as a core with modules. Database handling and implementation of security protocols are modules, to improve flexibility compared to other frameworks. (2) To ensure loosely coupled modules the system should implement an inversion of control mechanism. (3) A focus on ease of implementation requires the system should use HL7 FHIR (Fast Interoperable Health Resources) as the primary standard because it is based on web-technologies. We evaluated the feasibility of our architecture by developing an open source implementation of the system called ORDS. ORDS is written in TypeScript, and makes use of the Express Framework and HL7 FHIR DSTU2. The code is distributed on GitHub. All modules have been tested unit wise, but end-to-end testing awaits our first clinical example implementations. Our study showed that highly adaptable and yet interoperable core frameworks for telemedicine can be designed and implemented. Future work includes implementation of a clinical use case and evaluation. Copyright © 2018 Elsevier B.V. All rights reserved.

Outcome definitions and clinical predictors influence pharmacogenetic associations between HTR3A gene polymorphisms and response to clozapine in patients with schizophrenia.

PubMed

Rajkumar, A P; Poonkuzhali, B; Kuruvilla, A; Srivastava, A; Jacob, M; Jacob, K S

2012-12-01

Pharmacogenetics of schizophrenia has not yet delivered anticipated clinical dividends. Clinical heterogeneity of schizophrenia contributes to the poor replication of the findings of pharmacogenetic association studies. Functionally important HTR3A gene single-nucleotide polymorphisms (SNPs) were reported to be associated with response to clozapine. The aim of this study was to investigate how the association between HTR3A gene SNP and response to clozapine is influenced by various clinical predictors and by differing outcome definitions in patients with treatment-resistant schizophrenia (TRS). We recruited 101 consecutive patients with TRS, on stable doses of clozapine, and evaluated their HTR3A gene SNP (rs1062613 and rs2276302), psychopathology, and serum clozapine levels. We assessed their socio-demographic and clinical profiles, premorbid adjustment, traumatic events, cognition, and disability using standard assessment schedules. We evaluated their response to clozapine, by employing six differing outcome definitions. We employed appropriate multivariate statistics to calculate allelic and genotypic association, accounting for the effects of various clinical variables. T allele of rs1062613 and G allele of rs2276302 were significantly associated with good clinical response to clozapine (p = 0.02). However, varying outcome definitions make these associations inconsistent. rs1062613 and rs2276302 could explain only 13.8 % variability in the responses to clozapine, while combined clinical predictors and HTR3A pharmacogenetic association model could explain 38 % variability. We demonstrated that the results of pharmacogenetic studies in schizophrenia depend heavily on their outcome definitions and that combined clinical and pharmacogenetic models have better predictive values. Future pharmacogenetic studies should employ multiple outcome definitions and should evaluate associated clinical variables.

[The objective structured clinical evaluation of teaching in anaesthesiology and resuscitation].

PubMed

Echevarría Moreno, M; Prieto Vera, C; Martín Tellería, A; Neira Reina, F; Martín, J S; Fernández Jurado, M L; Luis Navarro, J C; Ortega Garcia, J L; Alarcón Martínez, L; López-Cuervo Derqui, R

2012-03-01

To find out the acquirement of professional competencies of Anaesthesiology and Resuscitation medical residents at the end of their training period using the Objective Structured Clinical Evaluation (OCSE) tool. Six competency components to evalúate were defined as follows: clinical interview (communication), technical ability and relationship abilities (leadership, decision making, work in a team), diagnostic assessment, therapeutic management, and medical records. Different methodologies were determined depending on the knowledge and skills to evaluate. Twelve clinical cases were developed that were performed in 12 stations. A total of 107 Ítems, specified within the stations, evaluated the competency components. A total of 43 residents were invited to participate in the last 4 months of their training in hospitals in Andalusia and Extremadura. A total of 33 residents participated. The overall mean of the classifications obtained in the 12 stations was 64.2 out of a maximum of 100. The medical residents demonstrated higher competency in obstetrics, paediatric anaesthesia, and that associated with difficult airway. The main competency gaps were detected in the area of one-day surgery, chronic pain, and literature management, in which approximately half passed the test. We believe that training evaluations, such as the OCSE, help in determining the skill levels of the medical resident, making it easier to continually improve the training of the future anaesthesiologist. Copyright © 2011 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España.. All rights reserved.

Evaluating Trauma Sonography for Operational Use in the Microgravity Environment

NASA Technical Reports Server (NTRS)

Kirkpatrick, Andrew W.; Jones, Jeffrey A.; Sargsyan, Ashot; Hamilton, Douglas; Melton, Shannon; Beck, George; Nicolaou, Savvas; Campbell, Mark; Dulchavsky, Scott

2007-01-01

Sonography is the only medical imaging modality aboard the ISS, and is likely to remain the leading imaging modality in future human space flight programs. While trauma sonography (TS) has been well recognized for terrestrial trauma settings, the technique had to be evaluated for suitability in space flight prior to adopting it as an operational capability. The authors found the following four-phased evaluative approach applicable to this task: 1) identifying standard or novel terrestrial techniques for potential use in space medicine; 2) developing and testing these techniques with suggested modifications on the ground (1g) either in clinical settings or in animal models, as appropriate; 3) evaluating and refining the techniques in parabolic flight (0g); and 4) validating and implementing for clinical use in space. In Phase I of the TS project, expert opinion and literature review suggested TS to be a potential screening tool for trauma in space. In Phase II, animal models were developed and tested in ground studies, and clinical studies were carried out in collaborating trauma centers. In Phase III, animal models were flight-tested in the NASA KC-135 Reduced Gravity Laboratory. Preliminary results of the first three phases demonstrated potential clinical utility of TS in microgravity. Phase IV studies have begun to address crew training issues, on-board imaging protocols, and data transfer procedures necessary to offer the modified TS technique for space use.

Conclusions and future directions for the REiNS International Collaboration

PubMed Central

Blakeley, Jaishri O.; Dombi, Eva; Fisher, Michael J.; Hanemann, Clemens O.; Walsh, Karin S.; Wolters, Pamela L.; Plotkin, Scott R.

2013-01-01

The Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration was established with the goal to develop consensus recommendations for the use of endpoints in neurofibromatosis (NF) clinical trials. This supplement includes the first series of REiNS recommendations for the use of patient-reported, functional, and visual outcomes, and for the evaluation of imaging response in NF clinical trials. Recommendations for neurocognitive outcome measures, the use of whole-body MRI in NF, the evaluation of potential biomarkers of disease, and the comprehensive evaluation of functional and patient-reported outcomes in NF are in development. The REiNS recommendations are made based on current knowledge. Experience with the use of the recommended endpoints in clinical trials, development of new tools and technologies, new knowledge of the natural history of NF, and advances in the methods used to analyze endpoints will likely lead to modifications of the currently proposed guidelines, which will be shared with the NF research community through the REiNS Web site www.reinscollaboration.org. Due to the clinical complexity of NF, there is a need to seek expertise from multiple medical disciplines, regulatory agencies, and industry to develop trial endpoints and designs, which will lead to the identification and approval of effective treatments for NF tumor and nontumor manifestations. The REiNS Collaboration welcomes anyone interested in providing his or her expertise toward this effort. PMID:24249805

Forecasting the absolute and relative shortage of physicians in Japan using a system dynamics model approach

PubMed Central

2013-01-01

Background In Japan, a shortage of physicians, who serve a key role in healthcare provision, has been pointed out as a major medical issue. The healthcare workforce policy planner should consider future dynamic changes in physician numbers. The purpose of this study was to propose a physician supply forecasting methodology by applying system dynamics modeling to estimate future absolute and relative numbers of physicians. Method We constructed a forecasting model using a system dynamics approach. Forecasting the number of physician was performed for all clinical physician and OB/GYN specialists. Moreover, we conducted evaluation of sufficiency for the number of physicians and sensitivity analysis. Result & conclusion As a result, it was forecast that the number of physicians would increase during 2008–2030 and the shortage would resolve at 2026 for all clinical physicians. However, the shortage would not resolve for the period covered. This suggests a need for measures for reconsidering the allocation system of new entry physicians to resolve maldistribution between medical departments, in addition, for increasing the overall number of clinical physicians. PMID:23981198

Lung capillary injury and repair in left heart disease: a new target for therapy?

PubMed

Azarbar, Sayena; Dupuis, Jocelyn

2014-07-01

The lungs are the primary organs affected in LHD (left heart disease). Increased left atrial pressure leads to pulmonary alveolar-capillary stress failure, resulting in cycles of alveolar wall injury and repair. The reparative process causes the proliferation of MYFs (myofibroblasts) with fibrosis and extracellular matrix deposition, resulting in thickening of the alveolar wall. Although the resultant reduction in vascular permeability is initially protective against pulmonary oedema, the process becomes maladaptive causing a restrictive lung syndrome with impaired gas exchange. This pathological process may also contribute to PH (pulmonary hypertension) due to LHD. Few clinical trials have specifically evaluated lung structural remodelling and the effect of related therapies in LHD. Currently approved treatment for chronic HF (heart failure) may have direct beneficial effects on lung structural remodelling. In the future, novel therapies specifically targeting the remodelling processes may potentially be utilized. In the present review, we summarize data supporting the clinical importance and pathophysiological mechanisms of lung structural remodelling in LHD and propose that this pathophysiological process should be explored further in pre-clinical studies and future therapeutic trials.

Forecasting the absolute and relative shortage of physicians in Japan using a system dynamics model approach.

PubMed

Ishikawa, Tomoki; Ohba, Hisateru; Yokooka, Yuki; Nakamura, Kozo; Ogasawara, Katsuhiko

2013-08-27

In Japan, a shortage of physicians, who serve a key role in healthcare provision, has been pointed out as a major medical issue. The healthcare workforce policy planner should consider future dynamic changes in physician numbers. The purpose of this study was to propose a physician supply forecasting methodology by applying system dynamics modeling to estimate future absolute and relative numbers of physicians. We constructed a forecasting model using a system dynamics approach. Forecasting the number of physician was performed for all clinical physician and OB/GYN specialists. Moreover, we conducted evaluation of sufficiency for the number of physicians and sensitivity analysis. As a result, it was forecast that the number of physicians would increase during 2008-2030 and the shortage would resolve at 2026 for all clinical physicians. However, the shortage would not resolve for the period covered. This suggests a need for measures for reconsidering the allocation system of new entry physicians to resolve maldistribution between medical departments, in addition, for increasing the overall number of clinical physicians.

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

PubMed Central

2014-01-01

Background There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. PMID:24885146

Using Qualitative Methods to Evaluate a Family Behavioral Intervention for Type 1 Diabetes

PubMed Central

Herbert, Linda Jones; Sweenie, Rachel; Kelly, Katherine Patterson; Holmes, Clarissa; Streisand, Randi

2013-01-01

Introduction The objectives of this study were to qualitatively evaluate a dyadic adolescent-parent type 1 diabetes (T1D) program developed to prevent deterioration in diabetes care among adolescents with T1D and provide recommendations for program refinement. Method Thirteen adolescent-parent dyads who participated in the larger RCT, the TeamWork Project, were interviewed regarding their perceptions of their participation in the program and current T1D challenges. Interviews were transcribed and coded to establish broad themes. Results Adolescents and parents thought the TeamWork Project sessions were helpful and taught them new information. Five themes catalog findings from the qualitative interviews: TeamWork content, TeamWork structure, transition of responsibility, current and future challenges, and future intervention considerations. Discussion Addressing T1D challenges as a parent-adolescent dyad via a behavioral clinic program is helpful to families during adolescence. Findings highlight the utility of qualitative evaluation to tailor interventions for the unique challenges related to pediatric chronic illness. PMID:24269281

Clinical application of near-infrared spectroscopy in patients with traumatic brain injury: a review of the progress of the field.

PubMed

Sen, Anish N; Gopinath, Shankar P; Robertson, Claudia S

2016-07-01

Near-infrared spectroscopy (NIRS) is a technique by which the interaction between light in the near-infrared spectrum and matter can be quantitatively measured to provide information about the particular chromophore. Study into the clinical application of NIRS for traumatic brain injury (TBI) began in the 1990s with early reports of the ability to detect intracranial hematomas using NIRS. We highlight the advances in clinical applications of NIRS over the past two decades as they relate to TBI. We discuss recent studies evaluating NIRS techniques for intracranial hematoma detection, followed by the clinical application of NIRS in intracranial pressure and brain oxygenation measurement, and conclude with a summary of potential future uses of NIRS in TBI patient management.

[Proposal for graduate school education in the future: from the viewpoint of the Department of clinical Laboratory in a university hospital].

PubMed

Ishii, Junichi

2009-08-01

Fujita Health University Hospital, located in Toyoake, is a large teaching hospital with 1,505 beds. The Department of Clinical Laboratory in our hospital, in which 136 medical technologists work, is one of the largest clinical laboratories in Japan. Medical technologists in our hospital are required not only to perform accurate laboratory examinations, but also to contribute to the medical care team. In addition, they must educate students and trainee medical technologists. Furthermore, they conduct research to develop and evaluate new laboratory methods. Thus, we hope that education in graduate schools of medical technology (Master's course), along with promoting the specialty of laboratory techniques, will develop students' clinical skills to examine patients and research skills to conduct studies.

From the RNA world to the clinic.

PubMed

Sullenger, Bruce A; Nair, Smita

2016-06-17

The study of RNA has continually emphasized the structural and functional versatility of RNA molecules. This versatility has inspired translational and clinical researchers to explore the utility of RNA-based therapeutic agents for a wide variety of medical applications. Several RNA therapeutics, with diverse modes of action, are being evaluated in large late-stage clinical trials, and many more are in early clinical development. Hundreds of patients are enrolled in large trials testing messenger RNAs to combat cancer, small interfering RNAs to treat renal and hepatic disorders, and aptamers to combat ocular and cardiovascular disease. Results from these studies are generating considerable interest among the biomedical community and the public and will be important for the future development of this emerging class of therapeutic agents. Copyright © 2016, American Association for the Advancement of Science.

NHS Blood Tracking Pilot: City University Evaluation Project

NASA Astrophysics Data System (ADS)

Goddard, Kate; Shabestari, Omid; Adriano, Juan; Kay, Jonathan; Roudsari, Abdul

Automation of healthcare processes is an emergent theme in the drive to increase patient safety. The Mayday Hospital has been chosen as the pilot site for the implementation of the Electronic Clinical Transfusion Management System to track blood from the point of ordering to the final transfusion. The Centre for Health Informatics at City University is carrying out an independent evaluation of the system implementation using a variety of methodologies to both formatively inform the implementation process and summatively provide an account of the lessons learned for future implementations.

Acne Scarring—Pathogenesis, Evaluation, and Treatment Options

PubMed Central

Connolly, Deirdre; Vu, Ha Linh; Mariwalla, Kavita

2017-01-01

Acne vulgaris is a ubiquitous problem affecting 80 percent of people ages 11 to 30 years, with many patients experiencing some degree of scarring. This review focuses on atrophic scars, the most common type of acne scar. We briefly address the cellular sequelae that lead to scar formation and the initial evaluation of patients with acne scars. We then discuss an algorithmic approach to the treatment of acne scarring based on the classification of scars into erythematous and atrophic types. Lastly, we discuss the future treatment of acne scars and ongoing clinical trials. PMID:29344322

Patients' attitudes and preferences about participation and recruitment strategies in clinical trials.

PubMed

Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S; Loehrer, Laura L; Wahner-Roedler, Dietlind L

2009-03-01

To assess attitudes of patients about participation in clinical trials. This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results.

Patients' Attitudes and Preferences About Participation and Recruitment Strategies in Clinical Trials

PubMed Central

Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S.; Loehrer, Laura L.; Wahner-Roedler, Dietlind L.

2009-01-01

OBJECTIVE: To assess attitudes of patients about participation in clinical trials. PATIENTS AND METHODS: This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. RESULTS: Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. CONCLUSION: Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results. PMID:19252111

Novel strategies in immunotherapy for allergic diseases

PubMed Central

Tham, Elizabeth Huiwen; Soh, Jian Yi; Van Bever, HP

2018-01-01

Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies. Future approaches may include fungal compounds, parasitic molecules, vitamin D, and traditional Chinese herbs. More robust comparative clinical trials are needed to evaluate the safety, clinical efficacy, and cost effectiveness of various adjuvants in order to determine ideal candidates in disease-specific and allergen-specific models. Other suggested approaches to further optimize outcomes of IT include early introduction of IT during an optimal window period. Alternative routes of administration of IT to optimize delivery and yet minimize potential side effects require further evaluation for safety and efficacy before they can be recommended. PMID:29732290

National Lipid Association Annual Summary of Clinical Lipidology 2015.

PubMed

Bays, Harold E; Jones, Peter H; Brown, W Virgil; Jacobson, Terry A

2014-01-01

The National Lipid Association (NLA) Annual Summary of Clinical Lipidology 2015 is a summary of principles important to the patient-centered evaluation, management, and care of patients with dyslipidemia. This summary is intended to be a "living document," with future annual updates based on emerging science, clinical considerations, and new NLA Position and Consensus Statements. The goal is to provide clinicians an ongoing resource that translates the latest advances in medical science toward the evaluation and treatment of patients with dyslipidemia. The 2015 NLA Annual Summary of Clinical Lipidology was founded on the principles of evidence-based medicine and is generally consistent with established national and international lipid guidelines. Topics include a general discussion of the 2014 NLA Recommendations for Patient-Centered Management of Dyslipidemia, genetics, secondary causes of dyslipidemia, biomarkers and "advanced lipid testing," medical nutrition, physical activity, obesity, pharmacotherapy, statin safety, lipid-altering drug interactions, lipoprotein apheresis, dyslipidemia in children and adolescence, dyslipidemia in older individuals, race/ethnicity, and women, health information technology and electronic medical records, as well as investigational lipid-altering drugs in development. Copyright © 2014 National Lipid Association. All rights reserved.

The Ling 6(HL) test: typical pediatric performance data and clinical use evaluation.

PubMed

Glista, Danielle; Scollie, Susan; Moodie, Sheila; Easwar, Vijayalakshmi

2014-01-01

The Ling 6(HL) test offers a calibrated version of naturally produced speech sounds in dB HL for evaluation of detection thresholds. Aided performance has been previously characterized in adults. The purpose of this work was to evaluate and refine the Ling 6(HL) test for use in pediatric hearing aid outcome measurement. This work is presented across two studies incorporating an integrated knowledge translation approach in the characterization of normative and typical performance, and in the evaluation of clinical feasibility, utility, acceptability, and implementation. A total of 57 children, 28 normally hearing and 29 with binaural sensorineural hearing loss, were included in Study 1. Children wore their own hearing aids fitted using Desired Sensation Level v5.0. Nine clinicians from The Network of Pediatric Audiologists participated in Study 2. A CD-based test format was used in the collection of unaided and aided detection thresholds in laboratory and clinical settings; thresholds were measured clinically as part of routine clinical care. Confidence intervals were derived to characterize normal performance and typical aided performance according to hearing loss severity. Unaided-aided performance was analyzed using a repeated-measures analysis of variance. The audiologists completed an online questionnaire evaluating the quality, feasibility/executability, utility/comparative value/relative advantage, acceptability/applicability, and interpretability, in addition to recommendation and general comments sections. Ling 6(HL) thresholds were reliably measured with children 3-18 yr old. Normative and typical performance ranges were translated into a scoring tool for use in pediatric outcome measurement. In general, questionnaire respondents generally agreed that the Ling 6(HL) test was a high-quality outcome evaluation tool that can be implemented successfully in clinical settings. By actively collaborating with pediatric audiologists and using an integrated knowledge translation framework, this work supported the creation of an evidence-based clinical tool that has the potential to be implemented in, and useful to, clinical practice. More research is needed to characterize performance in alternative listening conditions to facilitate use with infants, for example. Future efforts focused on monitoring the use of the Ling 6(HL) test in daily clinical practice may help describe whether clinical use has been maintained across time and if any additional adaptations are necessary to facilitate clinical uptake. American Academy of Audiology.

[Critical evaluation of the first draft of DSM-V].

PubMed

Frances, A

2011-02-16

Critical evaluation of DSM-V first draft This is an evaluation of the first DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) draft from the DSM-IV chairman. First, a brief history of DSM is reported. Then, major reasons for present controversies and the threat they raise to APA leadership in the field are discussed. Third point is careful recollection of the several conflicting aspects of the DSM-V draft, paying attention to drawbacks and their implications for future clinical practice, research and forensic activity. Comment is finally provided about APA (American Psychiatric Association) decisions aimed at reaching more consensus about this basic instrument of American psychiatry.

Impact of different concentrations of an octenidine dihydrochloride mouthwash on salivary bacterial counts: a randomized, placebo-controlled cross-over trial.

PubMed

Lorenz, Katrin; Jockel-Schneider, Yvonne; Petersen, Nicole; Stölzel, Peggy; Petzold, Markus; Vogel, Ulrich; Hoffmann, Thomas; Schlagenhauf, Ulrich; Noack, Barbara

2018-03-02

This bi-centric, placebo-controlled, randomized, evaluator-blinded, incomplete cross-over clinical phase II trial was initialized to identify the most appropriate concentration of octenidine dihydrochloride (OCT) in mouth rinses. Rinses of 0.10, 0.15, and 0.20% OCT were compared to a saline placebo rinse regarding the reduction of salivary bacterial counts (SBCs) in 90 gingivitis patients over 4 days. Changes in plaque (PI) and gingival index (GI), taste perception, and safety issues were evaluated. At baseline, the first OCT (0.10, 0.15, 0.20%) rinse resulted in a decrease of SBC (reduction by 3.63-5.44 log 10 colony forming units [CFU]) compared to placebo (p < 0.001). Differences between OCT concentrations were not verified. After 4 days, the last OCT rinse again resulted in a significant SBC decrease (3.69-4.22 log 10 CFU) compared to placebo (p < 0.001). Overall, SBC reduction between baseline and day 4 was significantly higher in OCT 0.15 and 0.20% groups compared to OCT 0.10% and placebo. Mean GI/PIs were significantly lower in OCT groups than in the placebo group (p < 0.001). Differences in GI/PI between OCT groups were not verified. Adverse effects increased with increasing OCT concentrations. Considering antibacterial efficacy, frequency of adverse events, and user acceptance, 0.10% OCT was identified as the preferred concentration to be used in future clinical trials. Due to its low toxicity and pronounced antibacterial properties, octenidine dihydrochloride (OCT) is a promising candidate for the use in antiseptic mouth rinses. OCT concentrations of 0.10% are recommended for future clinical trials evaluating the plaque-reducing properties of OCT mouth rinses. ( www.clinicaltrials.gov , NCT022138552).

Risk assessment analysis of the future technical unit dedicated to the evaluation and treatment of motor disabilities.

PubMed

Grelier, S; Thetio, M; Quentin, V; Achache, V; Sanchez, N; Leroux, V; Durand, E; Pequignot, R

2011-03-01

The National Hospital of Saint Maurice (HNSM) for Physical Medicine and Rehabilitation aims at strengthening its position as a pivot rehabilitation and physical therapy center. The opening in 2011 of a new unit for the evaluation and treatment of motor disabilities meets this objective. This project includes several parts: clinical, financial, architectural, organizational, applied clinical research as well as dealing with medical equipments and information system. This study focuses on the risk assessment of this future technical unit. This study was conducted by a group of professionals working for the hospital. It started with the design of a functional model to better comprehend the system to be analyzed. Risk assessment consists in confronting this functional model to a list of dangers in order to determine the vulnerable areas of the system. Then the team designed some scenarios to identify the causes, securities barriers and consequences in order to rank the risks. The analysis targeted various dangers, e.g. political, strategic, financial, economical, marketing, clinical and operational. The team identified more than 70 risky scenarios. For 75% of them the criticality level was deemed initially tolerable and under control or unacceptable. The implementation of an action plan for reducing the level of risks before opening this technical unit brought the system down to an acceptable level at 66%. A year prior to opening this technical unit for the evaluation and treatment of motor disabilities, conducting this preliminary risk assessment, with its exhaustive and rigorous methodology, enabled the concerned professionals to work together around an action plan for reducing the risks. 2011 Elsevier Masson SAS. All rights reserved.

Update on the evaluation and treatment of osteogenesis imperfecta.

PubMed

Harrington, Jennifer; Sochett, Etienne; Howard, Andrew

2014-12-01

Osteogenesis imperfecta (OI) is a heritable bone fragility disorder that presents with a wide clinical phenotype spectrum: from perinatal lethality and severe deformities to very mild forms without fractures. Most cases of OI are due to autosomal dominant mutations of the type I collagen genes. A multidisciplinary approach with rehabilitation, orthopedic surgery, and consideration of medical therapy with bisphosphonates underpins current management. Greater understanding of the pathogenesis of OI may lead to novel, therapeutic approaches to help improve clinical symptoms of children with OI in the future. Copyright © 2014 Elsevier Inc. All rights reserved.

A clinical protocol to increase chewing and assess mastication in children with feeding disorders.

PubMed

Volkert, Valerie M; Peterson, Kathryn M; Zeleny, Jason R; Piazza, Cathleen C

2014-09-01

Children with feeding disorders often cannot or do not chew when presented with table food. Children with chewing deficits also often swallow the bite before masticating it appropriately, which we will refer to as early swallowing. In the current study, we evaluated a clinical protocol to increase chews per bite, assess mastication, and eliminate early swallowing with three children with feeding disorders. The current study adds to a small body of literature on chewing and mastication of children with feeding disorders. Suggestions for future research are also discussed. © The Author(s) 2014.

Involving clinical librarians at the point of care: results of a controlled intervention.

PubMed

Aitken, Elizabeth M; Powelson, Susan E; Reaume, Renée D; Ghali, William A

2011-12-01

To measure the effect of including a clinical librarian in the health care team on medical residents and clinical clerks. In 2009, medical residents and clinical clerks were preassigned to one of two patient care teams (intervention and control). Each team had a month-long rotation on the general medicine teaching unit. The clinical librarian joined the intervention team for morning intake, clinical rounding, or an afternoon patient list review, providing immediate literature searches, formal group instruction, informal bedside teaching, and/or individual mentoring for use of preappraised resources and evidence-based medicine search techniques. Both intervention and control teams completed pre and post surveys comparing their confidence levels and awareness of resources as well as their self-reported use of evidence for making patient care decisions. The nonintervention team was surveyed as the control group. The clinical librarian intervention had a significant positive effect on medical trainees' self-reported ability to independently locate and evaluate evidence resources to support patient care decisions. Notably, 30 of 34 (88%) reported having changed a treatment plan based on skills taught by the clinical librarian, and 27 of 34 (79%) changed a treatment plan based on the librarian's mediated search support. Clinical librarians on the care team led to positive effects on self-reported provider attitudes, provider information retrieval tendencies, and, notably, clinical decision making. Future research should evaluate economic effects of widespread implementation of on-site clinical librarians.

Nucleic acid tests for the detection of alpha human papillomaviruses.

PubMed

Poljak, Mario; Cuzick, Jack; Kocjan, Boštjan J; Iftner, Thomas; Dillner, Joakim; Arbyn, Marc

2012-11-20

Testing for high-risk types of alpha human papillomaviruses (HPV) is an invaluable part of clinical guidelines for cervical carcinoma screening, management and treatment. In this comprehensive inventory of commercial tests for detection of alpha-HPV, we identified at least 125 distinct HPV tests and at least 84 variants of the original tests. However, only a small subset of HPV tests has documented clinical performance for any of the standard HPV testing indications. For more than 75% of HPV tests currently on the market, no single publication in peer-reviewed literature can be identified. HPV tests that have not been validated and lack proof of reliability, reproducibility and accuracy should not be used in clinical management. Once incorporated in the lab, it is essential that the whole procedure of HPV testing is subject to continuous and rigorous quality assurance to avoid sub-optimal, potentially harmful practices. Manufacturers of HPV tests are urged to put more effort into evaluating their current and future products analytically, using international standards, and for clinical applications, using clinically validated endpoints. To assist with analytical validation, the World Health Organization is developing international standards for HPV types other than HPV16 and HPV18 and is planning development of external quality control panels specifically designed to be used for performance evaluation of current and future HPV tests. There is a need for more competitively priced HPV tests, especially for resource-poor countries, and uniform test validation criteria based on international standards should enable issuing more competitive and fair tender notices for purchasing. Automation systems allowing large-scale testing, as well as further increases in clinical performance, are the main needs in the further improvement of HPV tests. This article forms part of a special supplement entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine Volume 30, Supplement 5, 2012. Copyright © 2012 Elsevier Ltd. All rights reserved.

A single mothers' group for mothers of children attending an outpatient psychiatric clinic: preliminary results.

PubMed

McNamee, J E; Lipman, E L; Hicks, F

1995-09-01

To provide a preliminary report of data from 2 support groups for single mothers, all of whom were mothers of children attending a child outpatient psychiatric clinic. The groups' 2 purposes were: 1. to assess the feasibility of adding structured evaluation to a common clinical intervention; 2. to improve single mothers' parenting skills through raised levels of self-esteem, increased capacity for family functioning and reduced levels of depression. Three structured evaluation instruments were used to measure the domains of self-esteem, family functioning and depression. These instruments were given to both groups of women on 3 occasions: 1. before the group; 2. after the group; 3. at a follow-up session 4 months after group termination. Open-ended questions were also asked at group termination. The questionnaire response rate was 100%; overall response rate for the 3 open-ended questions was 89%. Comparisons of pre-group and post-group scores showed that there was a significant increase in self-esteem (p < 0.01) and significant improvements in family functioning (p < 0.05) and depression (p < 0.01). It is possible to introduce a structured evaluation component into a common clinical intervention, and this support group seemed to assist single mothers' parenting skills. Methodologic concerns and future directions are discussed.

The intersection of physician wellbeing and clinical application of diabetes guidelines.

PubMed

Seehusen, Dean A; Deavers, Justin; Mainous, Arch G; Ledford, Christy J W

2018-05-01

Prediabetes (preDM) and diabetes are complex conditions that place significant strain on medical providers. This can have a negative impact on providers' wellbeing and could impact clinical decisions. We investigated the interplay of caring for patients with prediabetes, physician mental wellbeing, and clinical care. Using the theory of planned behavior, we conducted a secondary analysis to evaluate physicians' self-reported provision of care to patients with preDM. We evaluated the effect of mental wellbeing and perceived barriers to caring for patients with preDM. Among 1015 academic physicians, a greater perception of barriers to care and a higher percentage of patients seen with preDM were both significantly associated with a less positive physician state of mind. Physician state of mind was not associated with self-reported clinical behavior. Physician perception of patient barriers has a positive correlation with their likelihood of prescribing metformin for preDM. Caring for a larger proportion of patients with preDM is associated with worse mental wellbeing. Physician attitudes and subjective norms may predict adherence to guidelines, while physician attitudes and wellbeing affect self-reported prescribing behavior. Future research should evaluate ways to lessen the psychological burden of caring for patients with diabetes and preDM. Published by Elsevier B.V.

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

PubMed

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

2017-03-01

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

"I understood…but some parts were confusing and hard to grasp": Patients' perception of informed consent forms and clinical trials in Eldoret, Kenya.

PubMed

Naanyu, Violet; Some, Fatma F; Siika, Abraham M

2014-01-01

A signed informed consent (IC) form proves voluntary participation in a study. Yet the development of accessible and understandable IC forms comes with its own set of challenges, particularly when conducting international research. This study explores understanding by participants in an Eldoret-based clinical trial of IC and its implications as well as whether they will volunteer for future trials. In mid-2010, in-depth interviews with trial participants were recorded in audio format. Content analysis provides a description of trial participants' experiences and thoughts. All participants were informed about the trial and its voluntariness and they consented. However, some were too ill to scrutinize trial details. Thus, they relied on their health care provider's advice, or on their guardians. In general, participants understood their role and were happy to volunteer or invite others to participate in future trials. They also emphasised the importance of an open on-going dialogue in order for participants to be able to ask questions. Clinical trial participants in Eldoret seem to understand their role, but rely on providers and guardians when consenting. They are very willing to participate in future trials. Evaluation of research participants' opinions may improve trial protocols, increase comprehension and guard against manipulation of study participants. In addition, this research focus should guide development of consent forms and process that facilitates a truly IC.

Identification and preparation of sperm for ART.

PubMed

Mehta, Akanksha; Sigman, Mark

2014-02-01

State-of-the-art techniques attempt to select sperm with the best functional capacity to produce pregnancy and, subsequently, healthy offspring. A variety of approaches are now being evaluated. Future approaches may allow for selection of sperm based on sperm DNA integrity, degree of aneuploidy, or apoptosis. Other approaches involve attempting to improve the in vitro function of sperm with exposure to compounds such as pentoxifylline or platelet activating factor. In the future, we are likely to see significant improvements in the ability to select the best sperm for assisted-reproductive-technology procedures and the use of these procedures in routine clinical practice. Copyright © 2014 Elsevier Inc. All rights reserved.

KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors.

PubMed

Lentine, Krista L; Kasiske, Bertram L; Levey, Andrew S; Adams, Patricia L; Alberú, Josefina; Bakr, Mohamed A; Gallon, Lorenzo; Garvey, Catherine A; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L; Taler, Sandra J; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G; Cheung, Michael; Garg, Amit X

2017-08-01

The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a "proof-in-concept" risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided.In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017;101(Suppl 8S):S1-S109.

Quality Measures for Dialysis: Time for a Balanced Scorecard.

PubMed

Kliger, Alan S

2016-02-05

Recent federal legislation establishes a merit-based incentive payment system for physicians, with a scorecard for each professional. The Centers for Medicare and Medicaid Services evaluate quality of care with clinical performance measures and have used these metrics for public reporting and payment to dialysis facilities. Similar metrics may be used for the future merit-based incentive payment system. In nephrology, most clinical performance measures measure processes and intermediate outcomes of care. These metrics were developed from population studies of best practice and do not identify opportunities for individualizing care on the basis of patient characteristics and individual goals of treatment. The In-Center Hemodialysis (ICH) Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey examines patients' perception of care and has entered the arena to evaluate quality of care. A balanced scorecard of quality performance should include three elements: population-based best clinical practice, patient perceptions, and individually crafted patient goals of care. Copyright © 2016 by the American Society of Nephrology.

Sensory processing issues in young children presenting to an outpatient feeding clinic.

PubMed

Davis, Ann M; Bruce, Amanda S; Khasawneh, Rima; Schulz, Trina; Fox, Catherine; Dunn, Winifred

2013-02-01

The aim of the study was to describe the relation between sensory issues and medical complexity in a series of patients presenting to an outpatient multidisciplinary feeding team for evaluation, by a standardized measure of sensory-processing abilities. A retrospective chart review of all of the patients seen from 2004 to 2009 on 2 key variables: medical diagnostic category and short sensory profile (SSP) score. On the SSP, 67.6% of children scored in the clinical ("definite difference") range. The most common diagnostic categories were developmental (n = 23), gastrointestinal (n = 16), and neurological (n = 13). Behavioral and cardiorespiratory medical diagnostic categories were significantly related to SSP total score and SSP definite difference score. Children who present for feeding evaluation do indeed tend to have clinically elevated scores regarding sensory processing, and these elevated scores are significantly related to certain medical diagnostic categories. Future research is needed to determine why these significant relations exist as well as their implications for treatment of feeding-related issues.

Does NDPH exist? Some clinical considerations.

PubMed

Manzoni, G C; Torelli, P

2011-05-01

The analysis of case series of new daily persistent headache (NDPH) reported so far in the literature and the clinical evaluation of affected patients seen at headache clinics suggest that the current International Classification of Headache Disorders (ICHD-II) diagnostic criteria for NDPH are not adequate. In particular, in several instances headache features are not consistent with those of tension-type headache, as the ICHD-II expects. Before making a diagnosis of primary NDPH, it is imperative to rule out that it may be due to any underlying systemic disease. Just as importantly, the presence of psychiatric comorbidity and the possible role played by stressful life factors in triggering NDPH onset should also be searched for. Probably, it will only be through some future improvement in the classification of headache attributed to psychiatric disorder (chapter 12 of the ICHD-II) on the one hand, and through a careful psychological evaluation of patients currently diagnosed as NDPH sufferers on the other, that we will finally know whether primary NDPH actually exists.

Contemporary best practice in the evaluation and management of stuttering priapism.

PubMed

Kousournas, Georgios; Muneer, Asif; Ralph, David; Zacharakis, Evangelos

2017-01-01

Stuttering priapism is rare and under-investigated clinical entity. Although it shares similarities with ischaemic priapism, by definition, stuttering priapism has distinct characteristics that advocate for a different management in the clinical setting. Therefore, the management of stuttering priapism aims primarily to prevent recurrence rather than the resolution of spontaneous attacks. A multimodal approach and the individualization of each case are essential because of the diversity of the condition and the plethora of proposed therapeutic strategies. Understanding the underlying pathophysiology and familiarity with contemporary, past and emerging future agents and therapeutic options are required in order to provide an optimal solution for each patient. In addition, patient counselling and the option to combine therapeutic strategies and challenge second-line therapies are essential weapons in the armament of the urologist. Although further clinical trials and studies are mandatory in order to obtain solid data and provide recommendations, all therapeutic options are analysed, with specific interest in the potential advantages and disadvantages. A structured evaluation procedure is also described.

The Associations Between Clerkship Objective Structured Clinical Examination (OSCE) Grades and Subsequent Performance.

PubMed

Dong, Ting; Zahn, Christopher; Saguil, Aaron; Swygert, Kimberly A; Yoon, Michelle; Servey, Jessica; Durning, Steven

2017-01-01

Construct: We investigated the extent of the associations between medical students' clinical competency measured by performance in Objective Structured Clinical Examinations (OSCE) during Obstetrics/Gynecology and Family Medicine clerkships and later performance in both undergraduate and graduate medical education. There is a relative dearth of studies on the correlations between undergraduate OSCE scores and future exam performance within either undergraduate or graduate medical education and almost none on linking these simulated encounters to eventual patient care. Of the research studies that do correlate clerkship OSCE scores with future performance, these often have a small sample size and/or include only 1 clerkship. Students in USU graduating classes of 2007 through 2011 participated in the study. We investigated correlations between clerkship OSCE grades with United States Medical Licensing Examination Step 2 Clinical Knowledge, Clinical Skills, and Step 3 Exams scores as well as Postgraduate Year 1 program director's evaluation scores on Medical Expertise and Professionalism. We also conducted contingency table analysis to examine the associations between poor performance on clerkship OSCEs with failing Step 3 and receiving poor program director ratings. The correlation coefficients were weak between the clerkship OSCE grades and the outcomes. The strongest correlations existed between the clerkship OSCE grades and the Step 2 CS Integrated Clinical Encounter component score, Step 2 Clinical Skills, and Step 3 scores. Contingency table associations between poor performances on both clerkships OSCEs and poor Postgraduate Year 1 Program Director ratings were significant. The results of this study provide additional but limited validity evidence for the use of OSCEs during clinical clerkships given their associations with subsequent performance measures.

An evaluation of the role of the clinical education facilitator.

PubMed

McCormack, Brendan; Slater, Paul

2006-02-01

The objective of the study was to identify whether clinical education facilitators made a difference to the learning experiences of nurses in a large teaching hospital. Strategies for enabling continuous professional development are well established in health care organizations as key components of approaches to lifelong learning. The benefits of continuous professional development include the maintenance of high standards of care, the improvement and development of services, ensuring the competency of all nursing staff and guaranteeing the accountability of nurses for their actions. The role of clinical education facilitator is relatively new and little evaluation of this role has been undertaken. This study highlights important issues to be considered in developing a 'learning culture' in a hospital organization, through the adoption of such roles as clinical education facilitators. Whilst the roles have had an important function in the active coordination of learning activities in the hospital, there is little evidence of the role directly impacting on the learning culture of clinical settings. Learning mechanisms have been identified. The results of this evaluation can be subjected to further testing through ongoing evaluation of the outcomes arising from the learning mechanisms in place. Given the emphasis on work-based learning and continuing professional development in health care, then this ongoing evaluation can yield important information about future directions for nurse education. The study highlights the importance of supported learning in the workplace. However, more importantly, it identifies the need for a culture of professional practice to be developed in order to sustain learning in practice. Classroom-based learning alone, cannot create a culture of development in nursing and there is thus a need for models of work-based learning to be integrated into practice environments.

The MAPP research network: design, patient characterization and operations

PubMed Central

2014-01-01

Background The “Multidisciplinary Approach to the Study of Chronic Pelvic Pain” (MAPP) Research Network was established by the NIDDK to better understand the pathophysiology of urologic chronic pelvic pain syndromes (UCPPS), to inform future clinical trials and improve clinical care. The evolution, organization, and scientific scope of the MAPP Research Network, and the unique approach of the network’s central study and common data elements are described. Methods The primary scientific protocol for the Trans-MAPP Epidemiology/Phenotyping (EP) Study comprises a multi-site, longitudinal observational study, including bi-weekly internet-based symptom assessments, following a comprehensive in-clinic deep-phenotyping array of urological symptoms, non-urological symptoms and psychosocial factors to evaluate men and women with UCPPS. Healthy controls, matched on sex and age, as well as “positive” controls meeting the non-urologic associated syndromes (NUAS) criteria for one or more of the target conditions of Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) or Irritable Bowel Syndrome (IBS), were also evaluated. Additional, complementary studies addressing diverse hypotheses are integrated into the Trans-MAPP EP Study to provide a systemic characterization of study participants, including biomarker discovery studies of infectious agents, quantitative sensory testing, and structural and resting state neuroimaging and functional neurobiology studies. A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies. Recruitment into the central study occurred at six Discovery Sites in the United States, resulting in a total of 1,039 enrolled participants, exceeding the original targets. The biospecimen collection rate at baseline visits reached nearly 100%, and 279 participants underwent common neuroimaging through a standardized protocol. An extended follow-up study for 161 of the UCPPS participants is ongoing. Discussion The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS. Findings are expected to provide significant advances in understanding UCPPS pathophysiology that will ultimately inform future clinical trials and lead to improvements in patient care. Furthermore, the structure and methodologies developed by the MAPP Network provide the foundation upon which future studies of other urologic or non-urologic disorders can be based. Trial registration ClinicalTrials.gov identifier: NCT01098279 “Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)”. http://clinicaltrials.gov/show/NCT01098279 PMID:25085119

Nursing students' experiences of the clinical learning environment in nursing homes: a questionnaire study using the CLES+T evaluation scale.

PubMed

Carlson, Elisabeth; Idvall, Ewa

2014-07-01

One major challenge facing the health care systems worldwide is the growing demand for registered nurses able to provide qualified nursing care for a vulnerable population. Positive learning experiences during clinical practice influence not only learning outcomes, but also how students reason in relation to future career choices. To investigate student nurses' experiences of the clinical learning environment during clinical practice in nursing homes, and to compare perceptions among student nurses with or without prior work experience as health care assistants in elderly care. A cross-sectional study was designed, utilising the Swedish version of the CLES+T evaluation scale. 260 student nurses (response rate 76%) who had completed a five week long clinical placement in nursing homes returned the questionnaire during the data collection period in 2011-2012. Data were analysed using descriptive statistics. Mann-Whitney U-test was used to examine differences in relation to students with or without prior experience of elderly care. Overall, the clinical learning environment was evaluated in a predominantly positive way. The sub-dimension Supervisory relationship displayed the highest mean value, and the lowest score was calculated for the sub-dimension Leadership style of the ward manager. Statistical significant differences between sub-groups were displayed for four out of 34 items. The supervisory relationship had the greatest impact on how student nurses experienced the clinical learning environment in nursing homes. It is therefore, of utmost importance that collaborative activities, between educational and nursing home settings, supporting the work of preceptors are established and maintained. Copyright © 2014 Elsevier Ltd. All rights reserved.

Chinese SLE Treatment and Research group (CSTAR) registry: I. Major clinical characteristics of Chinese patients with systemic lupus erythematosus.

PubMed

Li, M; Zhang, W; Leng, X; Li, Z; Ye, Z; Li, C; Li, X; Zhu, P; Wang, Z; Zheng, Y; Li, X; Zhang, M; Zhang, F; Zhao, Y; Zeng, X

2013-10-01

The Chinese systemic lupus erythematosus (SLE) treatment and research group (CSTAR) provides major clinical characteristics of SLE in China and establishes a platform to provide resources for future basic and clinical studies. CSTAR originated as a multicentre, consecutive, and prospective design. The data were collected online from 104 rheumatology centers, which covered 30 provinces in China. The registered patients were required to meet four or more of the American College of Rheumatology (ACR) criteria for the classification of SLE. All CSTAR centers use the same protocol-directed methods to provide uniform evaluations, which included demographic data, clinical features, laboratory examinations, and disease activity evaluations. The patient samples, including DNA samples and sera, were also collected for further quality controls and additional studies. Preliminary analysis from 2104 baseline evaluations was available for this analysis. Of 1914 female and 190 male patients (F:M=10.1), the mean age at onset was 29.2 y with confirmed diagnosis one year later at the age of 30.3 y. Eighty four (4.2%) of 2002 patients had a family history of rheumatic diseases, including 34 (1.7%) cases with SLE. In addition, one hundred and seven (5.2%) abnormal pregnancies were recorded among 2026 experiences. The characteristics of the CSTAR cohort were compared to similarly sized cohorts from other studies. We found that 56.1% of patients presented with concurrent hematological disorders compared to only 18.2% of European patients. Moreover, 47.4% of patients presented with nephropathy compared to 27.9% of European patients. Conversely, neurological manifestations were only seen in 4.8% of Chinese SLE patients compared to 19.4% of European patients, 12.1% of U.S. patients, 22.8% of Malaysian patients and 26.4% of Latin Americans. Pulmonary arterial hypertension and interstitial lung diseases were complications identified in 3.8% and 4.2% of Chinese lupus patients, respectively. The CSTAR registry has provided epidemiological data and phenotypes of Chinese patients with SLE, and has demonstrated several differences between ethnicities. Clinical data and biologic samples would be valuable resources for future translational studies with national and international collaboration.

Value of information analysis optimizing future trial design from a pilot study on catheter securement devices.

PubMed

Tuffaha, Haitham W; Reynolds, Heather; Gordon, Louisa G; Rickard, Claire M; Scuffham, Paul A

2014-12-01

Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach, which is based on type I and type II errors, in determining sample sizes for randomized clinical trials. However, in addition to sample size calculation, value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times, by considering trial designs that maximize the expected net benefit of research, which is the difference between the expected cost of the trial and the expected value of additional information. To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial. An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices: standard polyurethane, tissue adhesive, bordered polyurethane and sutureless securement device. Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information. To guide the optimal future trial design, the expected costs and benefits of the alternative trial designs were estimated and compared. Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile. Among the possible designs for the future trial, a four-arm study with 220 patients/arm would provide the highest expected net benefit corresponding to 130% return-on-investment. The initially considered design of 388 patients/arm, based on hypothesis testing calculations, would provide lower net benefit with return-on-investment of 79%. Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation. Another limitation was that different follow-up durations for the larger trial were not evaluated. The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research. This approach should be considered early in the design of randomized clinical trials. © The Author(s) 2014.

Deep Patient: An Unsupervised Representation to Predict the Future of Patients from the Electronic Health Records

PubMed Central

Miotto, Riccardo; Li, Li; Kidd, Brian A.; Dudley, Joel T.

2016-01-01

Secondary use of electronic health records (EHRs) promises to advance clinical research and better inform clinical decision making. Challenges in summarizing and representing patient data prevent widespread practice of predictive modeling using EHRs. Here we present a novel unsupervised deep feature learning method to derive a general-purpose patient representation from EHR data that facilitates clinical predictive modeling. In particular, a three-layer stack of denoising autoencoders was used to capture hierarchical regularities and dependencies in the aggregated EHRs of about 700,000 patients from the Mount Sinai data warehouse. The result is a representation we name “deep patient”. We evaluated this representation as broadly predictive of health states by assessing the probability of patients to develop various diseases. We performed evaluation using 76,214 test patients comprising 78 diseases from diverse clinical domains and temporal windows. Our results significantly outperformed those achieved using representations based on raw EHR data and alternative feature learning strategies. Prediction performance for severe diabetes, schizophrenia, and various cancers were among the top performing. These findings indicate that deep learning applied to EHRs can derive patient representations that offer improved clinical predictions, and could provide a machine learning framework for augmenting clinical decision systems. PMID:27185194

Deep Patient: An Unsupervised Representation to Predict the Future of Patients from the Electronic Health Records

NASA Astrophysics Data System (ADS)

Miotto, Riccardo; Li, Li; Kidd, Brian A.; Dudley, Joel T.

2016-05-01

Secondary use of electronic health records (EHRs) promises to advance clinical research and better inform clinical decision making. Challenges in summarizing and representing patient data prevent widespread practice of predictive modeling using EHRs. Here we present a novel unsupervised deep feature learning method to derive a general-purpose patient representation from EHR data that facilitates clinical predictive modeling. In particular, a three-layer stack of denoising autoencoders was used to capture hierarchical regularities and dependencies in the aggregated EHRs of about 700,000 patients from the Mount Sinai data warehouse. The result is a representation we name “deep patient”. We evaluated this representation as broadly predictive of health states by assessing the probability of patients to develop various diseases. We performed evaluation using 76,214 test patients comprising 78 diseases from diverse clinical domains and temporal windows. Our results significantly outperformed those achieved using representations based on raw EHR data and alternative feature learning strategies. Prediction performance for severe diabetes, schizophrenia, and various cancers were among the top performing. These findings indicate that deep learning applied to EHRs can derive patient representations that offer improved clinical predictions, and could provide a machine learning framework for augmenting clinical decision systems.

Developing a primary dental care outreach (PDCO) course--part 1: practical issues and evaluation of clinical activity.

PubMed

Hind, V; Waterhouse, P J; Maguire, A; Tabari, D; Lloyd, J

2009-11-01

The primary dental care outreach (PDCO) course in Newcastle, UK commenced in September 2004 with dental undergraduates attending outreach clinics on a fortnightly rotation over a 2 year continuous placement. To evaluate the PDCO with respect to practical issues and clinical activity. Clinical activity data were collected using data sheets and Access software together with data on patient attendances and Structured Clinical Operative Tests (SCOTs). Comparative clinical data were collected from the same group of students in Child Dental Health (CDH) in the School of Dental Sciences. In 2004/2005, 1683 clinical procedures were undertaken in PDCO and 1362 in CDH. Of the treatment undertaken in PDCO, 37.1% was examination and treatment planning, 17.1% basic intracoronal restorations and 13.1% fissure sealing, the activity representative of day to day in general practice. Completion rates for the five piloted SCOTs in cross infection control, writing a prescription, writing a referral letter, taking a valid consent and taking a radiograph ranged from 74% to 97% in 2004/2006. The practical issues and challenges of delivering a new clinical course broadly related to induction of new PDCO staff, support of staff, establishing effective communication, timetabling logistics, delivery of clinical teaching and quality assurance. Once the practical issues and challenges of setting up a new clinical course have been overcome PDCO has a valuable role to play in preparing undergraduates for their future practising careers.

Silent Brain Infarction and Risk of Future Stroke: A Systematic Review and Meta-Analysis

PubMed Central

Gupta, Ajay; Giambrone, Ashley E.; Gialdini, Gino; Finn, Caitlin; Delgado, Diana; Gutierrez, Jose; Wright, Clinton; Beiser, Alexa S.; Seshadri, Sudha; Pandya, Ankur; Kamel, Hooman

2016-01-01

Background and Purpose Silent brain infarction (SBI) on magnetic resonance imaging (MRI) has been proposed as a subclinical risk marker for future symptomatic stroke. We performed a systematic review and meta-analysis to summarize the association between MRI-defined SBI and future stroke risk. Methods We searched the medical literature to identify cohort studies involving adults with MRI detection of SBI who were subsequently followed for incident clinically-defined stroke. Study data and quality assessment were recorded in duplicate with disagreements in data extraction resolved by a third reader. Strength association between MRI detected SBI and future symptomatic stroke measured by a hazard ratio (HR). Results The meta-analysis included 13 studies (14,764 subjects) with a mean follow-up ranging from 25.7 to 174 months. SBI predicted the occurrence of stroke with a random effects crude relative risk of 2.94 (95% CI 2.24–3.86, P<0.001; Q=39.65, P<0.001). In the eight studies of 10,427 subjects providing HR adjusted for cardiovascular risk factors, SBI was an independent predictor of incident stroke (HR 2.08 [95% CI 1.69–2.56, P<0.001]; Q=8.99, P=0.25). In a subgroup analysis pooling 9,483 stroke-free individuals from large population-based studies, SBI was present in ~18% of participants and remained a strong predictor of future stroke (HR 2.06 [95% CI 1.64–2.59], p<0.01). Conclusions SBI is present in approximately one in five stroke-free older adults and is associated with a 2-fold increased risk of future stroke. Future studies of in-depth stroke risk evaluations and intensive prevention measures are warranted in patients with clinically unrecognized radiologically evident brain infarctions. PMID:26888534

Mentor-mentee relationship in clinical microbiology.

PubMed

Opota, O; Greub, G

2017-07-01

Clinical microbiology is a field in constant evolution, with increasing technological opportunities and a growing emphasis on human and social issues. Maintaining knowledge and skills and anticipating future changes is challenging both for laboratory managers and for all the co-workers. Training and succession preparation represents a unique opportunity to adapt/prepare future generations according to the evolutions of the field. The aim of this review is to provide to clinical microbiologists a reflection on ongoing technological and social changes in their field and a deepening of the central role of preparing future generations to these changes through a fruitful mentor-mentee relationship. This narrative review relies on selected publications addressing mentor-mentee interactions in various academic fields, on interview with our colleagues and pairs, as well as on our personal experience. From the qualities and aspects that emerged as necessary for a productive mentor-mentee interaction, we selected and discuss five of them for the mentor: the role and responsibility, the positioning, the vision, the scientific credibility, and the moral credibility, as well as five for the mentee: creativity, flexibility, energy, responsibility, and self evaluation. This review emphasizes the importance of both the scientific and the ethical credibility of the mentor and the mentee as well as the importance of human and social values such as solidarity, equality, equity, respectfulness, and empathy, and might support mentor and mentee in the field of clinical microbiology and also in the field of infectious disease in their intent for a fruitful interaction. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

The Future of e-Learning in Medical Education: Current Trend and Future Opportunity

PubMed Central

2006-01-01

A wide range of e-learning modalities are widely integrated in medical education. However, some of the key questions related to the role of e-learning remain unanswered, such as (1) what is an effective approach to integrating technology into pre-clinical vs. clinical training?; (2) what evidence exists regarding the type and format of e-learning technology suitable for medical specialties and clinical settings?; (3) which design features are known to be effective in designing on-line patient simulation cases, tutorials, or clinical exams?; and (4) what guidelines exist for determining an appropriate blend of instructional strategies, including on-line learning, face-to-face instruction, and performance-based skill practices? Based on the existing literature and a variety of e-learning examples of synchronous learning tools and simulation technology, this paper addresses the following three questions: (1) what is the current trend of e-learning in medical education?; (2) what do we know about the effective use of e-learning?; and (3) what is the role of e-learning in facilitating newly emerging competency-based training? As e-learning continues to be widely integrated in training future physicians, it is critical that our efforts in conducting evaluative studies should target specific e-learning features that can best mediate intended learning goals and objectives. Without an evolving knowledge base on how best to design e-learning applications, the gap between what we know about technology use and how we deploy e-learning in training settings will continue to widen. PMID:19223995

From bench to almost bedside: the long road to a licensed Ebola virus vaccine.

PubMed

Wong, Gary; Mendoza, Emelissa J; Plummer, Francis A; Gao, George F; Kobinger, Gary P; Qiu, Xiangguo

2018-02-01

The Ebola virus (EBOV) disease epidemic during 2014-16 in West Africa has accelerated the clinical development of several vaccine candidates that have demonstrated efficacy in the gold standard nonhuman primate (NHP) model, namely cynomolgus macaques. Areas covered: This review discusses the pre-clinical research and if available, clinical evaluation of the currently available EBOV vaccine candidates, while emphasizing the translatability of pre-clinical data generated in the NHP model to clinical data in humans. Expert opinion: Despite the existence of many successful EBOV vaccine candidates in the pre-clinical stages, only two platforms became the focus of Phase 2/3 efficacy trials in Liberia, Sierra Leone, and Guinea near the peak of the epidemic: the Vesicular stomatitis virus (VSV)-vectored vaccine and the chimpanzee adenovirus type 3 (ChAd3)-vectored vaccine. The results of three distinct clinical trials involving these candidates may soon pave the way for a licensed, safe and efficacious EBOV vaccine to help combat future epidemics.

From bench to almost bedside: The long road to a licensed Ebola virus vaccine

PubMed Central

Wong, Gary; Mendoza, Emelissa J.; Plummer, Francis A.; Gao, George F.; Kobinger, Gary P.; Qiu, Xiangguo

2018-01-01

Introduction The Ebola virus (EBOV) disease epidemic during 2014-16 in West Africa has accelerated the clinical development of several vaccine candidates that have demonstrated efficacy in the gold standard nonhuman primate (NHP) model, namely cynomolgus macaques. Areas covered This review discusses the pre-clinical research and if available, clinical evaluation of the currently available EBOV vaccine candidates, while emphasizing the translatability of pre-clinical data generated in the NHP model to clinical data in humans. Expert opinion Despite the existence of many successful EBOV vaccine candidates in the pre-clinical stages, only two platforms became the focus of Phase 2/3 efficacy trials in Liberia, Sierra Leone, and Guinea near the peak of the epidemic: the Vesicular stomatitis virus (VSV)-vectored vaccine and the chimpanzee adenovirus type 3 (ChAd3)-vectored vaccine. The results of three distinct clinical trials involving these candidates may soon pave the way for a licensed, safe and efficacious EBOV vaccine to help combat future epidemics. PMID:29148858

Measuring outcomes of type 2 diabetes disease management program in an HMO setting.

PubMed

Ibrahim, Ibrahim Awad; Beich, Jeff; Sidorov, Jaan; Gabbay, Robert; Yu, Lucy

2002-01-01

There is a need to evaluate empirical disease management programs used in managing chronic diseases such as diabetes mellitus in managed care settings. We analyzed data from 252 patients with type 2 diabetes before and 1 year after enrollment in a disease management program. We examined clinical indicators such as HbA1C, HDL, LDL, total cholesterol, diastolic blood pressure, and BMI in addition to self-reported health status measured by SF-36 instrument. All clinical indicators showed statistically and clinically significant improvements. Only vitality and mental health showed statistically significant improvements in health status. Weak to moderate significant correlation between clinical indicators and health status was observed. Disease management can be effective at making significant clinical improvements for participants in a mixed-model HMO setting. No strong relationship between clinical indicators and health status was found. Future research is needed using a more specific health status measuring instrument and a randomized clinical trial design.

The Roles of Ethnicity, Sex, and Parental Pain Modeling in Rating of Experienced and Imagined Pain Events

PubMed Central

Boissoneault, Jeff; Bunch, Jennifer R.; Robinson, Michael

2015-01-01

To investigate the association of ethnicity, sex, and parental pain modeling on the evaluation of experienced and imagined painful events, 173 healthy volunteers (96 women) completed the Prior Pain Experience Questionnaire, a 79-question assessment of the intensity of painful events, and a questionnaire regarding exposure to parental pain models. Consistent with existing literature, greater ratings of experienced pain were noted among Black vs. White participants. Parental pain modeling was associated with higher imagined pain ratings, but only when the parent matched the participant’s sex. This effect was greater among White and Asian participants than Black or Hispanic participants, implying ethno-cultural effects may moderate the influence of pain modeling on the evaluation of imagined pain events. The clinical implications of these findings, as well as the predictive ability of imagined pain ratings for determining future experiences of pain, should be investigated in future studies. PMID:26085306

The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.

PubMed

Bijwaard, Karen; Dickey, Jennifer S; Kelm, Kellie; Težak, Živana

2015-01-01

The rapid emergence and clinical translation of novel high-throughput sequencing technologies created a need to clarify the regulatory pathway for the evaluation and authorization of these unique technologies. Recently, the US FDA authorized for marketing four next generation sequencing (NGS)-based diagnostic devices which consisted of two heritable disease-specific assays, library preparation reagents and a NGS platform that are intended for human germline targeted sequencing from whole blood. These first authorizations can serve as a case study in how different types of NGS-based technology are reviewed by the FDA. In this manuscript we describe challenges associated with the evaluation of these novel technologies and provide an overview of what was reviewed. Besides making validated NGS-based devices available for in vitro diagnostic use, these first authorizations create a regulatory path for similar future instruments and assays.

Alzheimer's Caregiver Support Online: lessons learned, initial findings and future directions.

PubMed

Glueckauf, Robert L; Loomis, Jeffrey S

2003-01-01

Family caregivers of older adults with progressive dementia (e.g., Alzheimer's disease) are faced with a variety of emotional and behavioral difficulties, such as dealing with persistent, repetitive questions, managing agitation and depression, and monitoring hygiene and self-care activities. Although professional and governmental organizations have called for the creation of community-based education and support programs, most dementia caregivers continue to receive little or no formal instruction in responding effectively to these challenges. The current paper describes the development and implementation of Alzheimer's Caregiver Support Online, a Web- and telephone-based education and support network for caregivers of individuals with progressive dementia. Lessons learned from the first two years of this state-supported initiative are discussed, followed by the findings of a Robert Wood Johnson Foundation-funded strategic marketing initiative and an initial program evaluation of AlzOnline's Positive Caregiving classes. Finally, clinical implications and future directions for program development and evaluation research are proposed.

Measurement properties of existing clinical assessment methods evaluating scapular positioning and function. A systematic review.

PubMed

Larsen, Camilla Marie; Juul-Kristensen, Birgit; Lund, Hans; Søgaard, Karen

2014-10-01

The aims were to compile a schematic overview of clinical scapular assessment methods and critically appraise the methodological quality of the involved studies. A systematic, computer-assisted literature search using Medline, CINAHL, SportDiscus and EMBASE was performed from inception to October 2013. Reference lists in articles were also screened for publications. From 50 articles, 54 method names were identified and categorized into three groups: (1) Static positioning assessment (n = 19); (2) Semi-dynamic (n = 13); and (3) Dynamic functional assessment (n = 22). Fifteen studies were excluded for evaluation due to no/few clinimetric results, leaving 35 studies for evaluation. Graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN checklist), the methodological quality in the reliability and validity domains was "fair" (57%) to "poor" (43%), with only one study rated as "good". The reliability domain was most often investigated. Few of the assessment methods in the included studies that had "fair" or "good" measurement property ratings demonstrated acceptable results for both reliability and validity. We found a substantially larger number of clinical scapular assessment methods than previously reported. Using the COSMIN checklist the methodological quality of the included measurement properties in the reliability and validity domains were in general "fair" to "poor". None were examined for all three domains: (1) reliability; (2) validity; and (3) responsiveness. Observational evaluation systems and assessment of scapular upward rotation seem suitably evidence-based for clinical use. Future studies should test and improve the clinimetric properties, and especially diagnostic accuracy and responsiveness, to increase utility for clinical practice.

Designing clinical trials of interventions for mobility disability: results from the lifestyle interventions and independence for elders pilot (LIFE-P) trial.

PubMed

Espeland, Mark A; Gill, Thomas M; Guralnik, Jack; Miller, Michael E; Fielding, Roger; Newman, Anne B; Pahor, Marco

2007-11-01

Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. Results are described from a pilot clinical trial in which 424 volunteers aged 70-89 years were randomly assigned to one of two interventions-physical activity or a healthy aging education program-and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in < or =10 seconds, a physical performance battery, and a questionnaire focused on physical function. Changes in all four outcomes were interrelated over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e., appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A 4-year trial based on the outcome of the 400-meter walk is projected to require N = 962-2234 to detect an intervention effect of 30%-20% with 90% power. Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400-meter walk as their primary outcome.

Patient representatives' views on patient information in clinical cancer trials.

PubMed

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-02-01

Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

Recommendations for designing and conducting veterinary clinical pathology biologic variation studies.

PubMed

Freeman, Kathleen P; Baral, Randolph M; Dhand, Navneet K; Nielsen, Søren Saxmose; Jensen, Asger L

2017-06-01

The recent creation of a veterinary clinical pathology biologic variation website has highlighted the need to provide recommendations for future studies of biologic variation in animals in order to help standardize and improve the quality of published information and to facilitate review and selection of publications as standard references. The following recommendations are provided in the format and order commonly found in veterinary publications. A checklist is provided to aid in planning, implementing, and evaluating veterinary studies on biologic variation (Appendix S1). These recommendations provide a valuable resource for clinicians, laboratorians, and researchers interested in conducting studies of biologic variation and in determining the quality of studies of biologic variation in veterinary laboratory testing. © 2017 American Society for Veterinary Clinical Pathology.

[Use of evidence in heath policies and programs contributions of the instituto nacional de salud].

PubMed

Gutierrez, Ericson L; Piazza, Marina; Gutierrez-Aguado, Alfonso; Hijar, Gisely; Carmona, Gloria; Caballero, Patricia; Reyes, Nora; Canelo, Carlos; Aparco, Juan Pablo; Tejada, Romina A; Bolaños-Díaz, Rafael; Saravia, Silvia; Gozzer, Ernesto

2016-01-01

This article analyzes some examples about how the Ministry of Health of Peru has used evidence for policy and program formulation, implementation and evaluation. It describes the process by which health budget programs are based and strengthened with scientific evidence. Provides an overview about how the development of clinical guidelines methodology is facilitating the generation of high quality evidence based clinical guidelines.It presents some examples of specific information needs of the Ministry of Health to which the Instituto Nacional de Salud has responded, and the impact of that collaboration. Finally, the article proposes future directions for the use of research methodology especially relevant for the development and evaluation of policy and programs, as well as the development of networks of health technology assessment at the national and international level.

Motor Rehabilitation Using Kinect: A Systematic Review.

PubMed

Da Gama, Alana; Fallavollita, Pascal; Teichrieb, Veronica; Navab, Nassir

2015-04-01

Interactive systems are being developed with the intention to help in the engagement of patients on various therapies. Amid the recent technological advances, Kinect™ from Microsoft (Redmond, WA) has helped pave the way on how user interaction technology facilitates and complements many clinical applications. In order to examine the actual status of Kinect developments for rehabilitation, this article presents a systematic review of articles that involve interactive, evaluative, and technical advances related to motor rehabilitation. Systematic research was performed in the IEEE Xplore and PubMed databases using the key word combination "Kinect AND rehabilitation" with the following inclusion criteria: (1) English language, (2) page number >4, (3) Kinect system for assistive interaction or clinical evaluation, or (4) Kinect system for improvement or evaluation of the sensor tracking or movement recognition. Quality assessment was performed by QualSyst standards. In total, 109 articles were found in the database research, from which 31 were included in the review: 13 were focused on the development of assistive systems for rehabilitation, 3 in evaluation, 3 in the applicability category, 7 on validation of Kinect anatomic and clinical evaluation, and 5 on improvement techniques. Quality analysis of all included articles is also presented with their respective QualSyst checklist scores. Research and development possibilities and future works with the Kinect for rehabilitation application are extensive. Methodological improvements when performing studies on this area need to be further investigated.

Implementation of workflow engine technology to deliver basic clinical decision support functionality.

PubMed

Huser, Vojtech; Rasmussen, Luke V; Oberg, Ryan; Starren, Justin B

2011-04-10

Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. We describe an implementation of a free workflow technology software suite (available at http://code.google.com/p/healthflow) and its application in the domain of clinical decision support. Our implementation seamlessly supports clinical logic testing on retrospective data and offers a user-friendly knowledge representation paradigm. With the presented software implementation, we demonstrate that workflow engine technology can provide a decision support platform which evaluates well against an established clinical decision support architecture evaluation framework. Due to cross-industry usage of workflow engine technology, we can expect significant future functionality enhancements that will further improve the technology's capacity to serve as a clinical decision support platform.

Drug Information Services Today: Current Role and Future Perspectives in Rational Drug Therapy.

PubMed

Amundstuen Reppe, Linda; Spigset, Olav; Schjøtt, Jan

2016-02-01

Polypharmacy and complex drug treatment regimens are becoming increasingly common, which may lead to adverse drug reactions, drug interactions, medication nonadherence, and increasing costs and thus challenge the rational use of drugs. At the same time, the accessibility of drug information increases, and health care professionals may have limited opportunities and capabilities to search and critically evaluate drug information. Clinicians have reported difficulties in searching the best evidence and translating study findings into clinically meaningful information applicable to specific patients. Consequently, it remains a challenge to ensure the rational use of drugs in the years to come. Drug information centers (DICs) have been established to promote the rational use of drugs. One of the most important tasks of DICs is the question and answer services for health care professionals posing drug-related questions. DICs staffed by pharmacists and clinical pharmacologists hold expertise in searching for drug information and critical evaluation of the literature. The uniqueness in this service lies not only in the identification and interpretation of the scientific literature but also in the adaptation of the findings into specific clinical situations and the discussion of possible solutions with the enquirer. Thus, DICs could provide valuable decision support to the clinic. Taking into account the increasing number of possible drug-related questions that will arise today and in the future, the DICs will remain highly relevant in the years to come. However, the DICs must follow the developments in health information technology to disseminate relevant, unbiased drug information to old and new users of the service. Moreover, the DICs are important tools to counterbalance the drug information published by the pharmaceutical industry. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Evaluating the Past, Present, and Future of Regenerative Medicine: A Global View.

PubMed

Ronfard, Vincent; Vertès, Alain A; May, Michael H; Dupraz, Anne; van Dyke, Mark E; Bayon, Yves

2017-04-01

"Evaluating the Past and Present of Regenerative Medicine (RM)" was the first part of an Industry Symposium dedicated to the subject during the 2015 TERMIS World Congress in Boston. This working session presented a critical review of the current RM landscape in Europe and North America with possible projections for the future. Interestingly, the RM development cycle seems to obey the Gartner hype cycle, now at the enlightenment phase, after past exaggerated expectations and discouragements, as suggested by increasing numbers of clinical trials and recent market approvals of RM solutions in both Europe (Glybera and Holoclar ® from Chiesi Pharma and Strimvelis ® from GSK) and Japan (Remestemcel-L from Mesoblast ® ). The successful commercial translation of RM research is governed by five major drivers: (i) fully validated manufacturing capability for autologous or allogeneic products, (ii) reimbursement for targeted clinical indications with high and demonstrable medico-economic benefits versus standard of care, (iii) implication of regulatory bodies in the design and development plan of any RM solution, which should be well characterized, robust, with proven consistent efficacy and an acceptable and controlled positive benefit/risk ratio, (iv) collaborations facilitated by multicompetence hubs/consortia of excellence, (v) well-thought-out clinical development plans for reducing the risk of failure. Benefiting from past and present experience, the RM burgeoning industry is expected to accelerate the market release of cost-effective RM products with real curative potential for specific clinical indications with high unmet needs. This should be achieved by wisely leveraging all possible synergies of the different stakeholders, for example, patients, clinicians, reimbursement and health technology assessment (HTA) agencies, regulatory authorities, public/private investors, academia, and companies.

Acute respiratory distress syndrome 40 years later: time to revisit its definition.

PubMed

Phua, Jason; Stewart, Thomas E; Ferguson, Niall D

2008-10-01

Acute respiratory distress syndrome is a common disorder associated with significant mortality and morbidity. The aim of this article is to critically evaluate the definition of acute respiratory distress syndrome and examine the impact the definition has on clinical practice and research. Articles from a MEDLINE search (1950 to August 2007) using the Medical Subject Heading respiratory distress syndrome, adult, diagnosis, limited to the English language and human subjects, their relevant bibliographies, and personal collections, were reviewed. The definition of acute respiratory distress syndrome is important to researchers, clinicians, and administrators alike. It has evolved significantly over the last 40 years, culminating in the American-European Consensus Conference definition, which was published in 1994. Although the American-European Consensus Conference definition is widely used, it has some important limitations that may impact on the conduct of clinical research, on resource allocation, and ultimately on the bedside management of such patients. These limitations stem partially from the fact that as defined, acute respiratory distress syndrome is a heterogeneous entity and also involve the reliability and validity of the criteria used in the definition. This article critically evaluates the American-European Consensus Conference definition and its limitations. Importantly, it highlights how these limitations may contribute to clinical trials that have failed to detect a potential true treatment effect. Finally, recommendations are made that could be considered in future definition modifications with an emphasis on the significance of accurately identifying the target population in future trials and subsequently in clinical care. How acute respiratory distress syndrome is defined has a significant impact on the results of randomized, controlled trials and epidemiologic studies. Changes to the current American-European Consensus Conference definition are likely to have an important role in advancing the understanding and management of acute respiratory distress syndrome.

Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation

PubMed Central

Grogl, Max; Boni, Marina; Carvalho, Edgar M.; Chebli, Houda; Cisse, Mamoudou; Diro, Ermias; Fernandes Cota, Gláucia; Erber, Astrid C.; Gadisa, Endalamaw; Handjani, Farhad; Khamesipour, Ali; Llanos-Cuentas, Alejandro; López Carvajal, Liliana; Grout, Lise; Lmimouni, Badre Eddine; Mokni, Mourad; Nahzat, Mohammad Sami; Ben Salah, Afif; Ozbel, Yusuf; Pascale, Juan Miguel; Rizzo Molina, Nidia; Rode, Joelle; Romero, Gustavo; Ruiz-Postigo, José Antonio; Gore Saravia, Nancy; Soto, Jaime; Uzun, Soner; Mashayekhi, Vahid; Vélez, Ivan Dario; Vogt, Florian; Zerpa, Olga; Arana, Byron

2018-01-01

Introduction Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL). Materials and methods Using a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings. Results Findings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized. Conclusions The consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments. PMID:29329311

The diagnosis of idiopathic pulmonary fibrosis: current and future approaches

PubMed Central

Martinez, Fernando J; Chisholm, Alison; Collard, Harold R; Flaherty, Kevin R; Myers, Jeffrey; Raghu, Ganesh; Walsh, Simon LF; White, Eric S; Richeldi, Luca

2017-01-01

With the recent development of two effective treatments for patients with idiopathic pulmonary fibrosis, an accurate diagnosis is crucial. The traditional approach to diagnosis emphasises the importance of thorough clinical and laboratory evaluations to exclude secondary causes of disease. High-resolution CT is a critical initial diagnostic test and acts as a tool to identify patients who should undergo surgical lung biopsy to secure a definitive histological diagnosis of usual interstitial pneumonia pattern. This diagnostic approach faces several challenges. Many patients with suspected idiopathic pulmonary fibrosis present with atypical high-resolution CT characteristics but are unfit for surgical lung biopsy, therefore preventing a confident diagnosis. The state of the art suggests an iterative, multidisciplinary process that incorporates available clinical, laboratory, imaging, and histological features. Recent research has explored genomic techniques to molecularly phenotype patients with interstitial lung disease. In the future, clinicians will probably use blood-specific or lung-specific molecular markers in combination with other clinical, physiological, and imaging features to enhance diagnostic efforts, refine prognostic recommendations, and influence the initial or subsequent treatment options. There is an urgent and increasing need for well designed, large, prospective studies measuring the effect of different diagnostic approaches. Ultimately, this will help to inform the development of guidelines and tailor clinical practice for the benefit of patients. PMID:27932290

Everolimus as first line therapy for pancreatic neuroendocrine tumours: current knowledge and future perspectives.

PubMed

Gallo, Marco; Malandrino, Pasqualino; Fanciulli, Giuseppe; Rota, Francesca; Faggiano, Antongiulio; Colao, Annamaria

2017-07-01

Everolimus has been shown to be effective for advanced pancreatic neuroendocrine tumours (pNETs), but its positioning in the therapeutic algorithm for pNETs is matter of debate. With the aim to shed light on this point, we performed an up-to-date critical review taking into account the results of both retrospective and prospective published studies, and the recommendations of international guidelines. In addition, we performed an extensive search on the Clinical Trial Registries databases worldwide, to gather information on the ongoing clinical trials related to this specific topic. We identified eight retrospective published studies, two prospective published studies, and five registered clinical trials. Moreover, we analyzed the content of four widespread international guidelines. Our critical review confirms the lack of high-quality data to recommend everolimus as the first line therapy for pNETs. The ongoing clinical trials reported in this review will hopefully help clinicians, in the near future, to better evaluate the role of everolimus as the first line therapy for pNETs. However, at the moment, there is already enough evidence to recommend everolimus as the first line therapy for patients with symptomatic malignant unresectable insulin-secreting pNETs, to control the endocrine syndrome regardless of tumour growth.

Open-source Software for Demand Forecasting of Clinical Laboratory Test Volumes Using Time-series Analysis.

PubMed

Mohammed, Emad A; Naugler, Christopher

2017-01-01

Demand forecasting is the area of predictive analytics devoted to predicting future volumes of services or consumables. Fair understanding and estimation of how demand will vary facilitates the optimal utilization of resources. In a medical laboratory, accurate forecasting of future demand, that is, test volumes, can increase efficiency and facilitate long-term laboratory planning. Importantly, in an era of utilization management initiatives, accurately predicted volumes compared to the realized test volumes can form a precise way to evaluate utilization management initiatives. Laboratory test volumes are often highly amenable to forecasting by time-series models; however, the statistical software needed to do this is generally either expensive or highly technical. In this paper, we describe an open-source web-based software tool for time-series forecasting and explain how to use it as a demand forecasting tool in clinical laboratories to estimate test volumes. This tool has three different models, that is, Holt-Winters multiplicative, Holt-Winters additive, and simple linear regression. Moreover, these models are ranked and the best one is highlighted. This tool will allow anyone with historic test volume data to model future demand.

Open-source Software for Demand Forecasting of Clinical Laboratory Test Volumes Using Time-series Analysis

PubMed Central

Mohammed, Emad A.; Naugler, Christopher

2017-01-01

Background: Demand forecasting is the area of predictive analytics devoted to predicting future volumes of services or consumables. Fair understanding and estimation of how demand will vary facilitates the optimal utilization of resources. In a medical laboratory, accurate forecasting of future demand, that is, test volumes, can increase efficiency and facilitate long-term laboratory planning. Importantly, in an era of utilization management initiatives, accurately predicted volumes compared to the realized test volumes can form a precise way to evaluate utilization management initiatives. Laboratory test volumes are often highly amenable to forecasting by time-series models; however, the statistical software needed to do this is generally either expensive or highly technical. Method: In this paper, we describe an open-source web-based software tool for time-series forecasting and explain how to use it as a demand forecasting tool in clinical laboratories to estimate test volumes. Results: This tool has three different models, that is, Holt-Winters multiplicative, Holt-Winters additive, and simple linear regression. Moreover, these models are ranked and the best one is highlighted. Conclusion: This tool will allow anyone with historic test volume data to model future demand. PMID:28400996

Ginseng and Anticancer Drug Combination to Improve Cancer Chemotherapy: A Critical Review

PubMed Central

Chen, Shihong; Huang, Ying; O'Barr, Stephen A.; Wong, Rebecca A.; Chow, Moses Sing Sum

2014-01-01

Ginseng, a well-known herb, is often used in combination with anticancer drugs to enhance chemotherapy. Its wide usage as well as many documentations are often cited to support its clinical benefit of such combination therapy. However the literature based on objective evidence to make such recommendation is still lacking. The present review critically evaluated relevant studies reported in English and Chinese literature on such combination. Based on our review, we found good evidence from in vitro and in vivo animal studies showing enhanced antitumor effect when ginseng is used in combination with some anticancer drugs. However, there is insufficient clinical evidence of such benefit as very few clinical studies are available. Future research should focus on clinically relevant studies of such combination to validate the utility of ginseng in cancer. PMID:24876866

Candida bloodstream infection: a clinical microbiology laboratory perspective.

PubMed

Pongrácz, Júlia; Kristóf, Katalin

2014-09-01

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

[Clinical and radiographic evaluation of a new percutaneous technique for moderate to severe hallux valgus deformity].

PubMed

Vélez-de Lachica, J C; Valdez-Jiménez, L A; Inzunza-Sánchez, J M

2017-01-01

Hallux valgus is considered the most common musculoskeletal deformity, with a prevalence of 88%. There are more than 130 surgical techniques for its treatment; currently, percutaneous ones are popular; however, they do not take into account the metatarsal-phalangeal correction angle. The aim of this study is to propose a modified technique for the correction of the percutaneous metatarsal-phalangeal and inter-metatarsal angles and to evaluate its clinical and radiological results. An experimental, prospective and longitudinal study in 10 patients with moderate to severe hallux valgus according to the classification of Coughlin and Mann were collected; the results were evaluated with the AOFAS scale at 15, 30, 60 and 90 days. The McBride technique and the technique of percutaneous anchor with the proposed amendment were performed. The AOFAS scale was applied as described, finding a progressive increase of the rating; the average correction of the inter-metatarsal angle was 8.8 degrees and of the metatarsal-phalangeal, 9.12. The modified technique of percutaneous anchor showed clear clinical and radiographic improvements in the short term. Our modified technique is proposed for future projects, including a large sample with long-term follow-up.

Evaluation of a depression screening and treatment program in primary care for patients with diabetes mellitus: insights and future directions.

PubMed

Palmer, Carrie; Vorderstrasse, Allison; Weil, Amy; Colford, Cristin; Dolan-Soto, Diane

2015-03-01

To evaluate a collaborative depression care program by assessing adherence to the program by internal medicine clinic (IMC) staff, and the program's effectiveness in treating depression in patients with diabetes mellitus. We also describe the rate of depression among patients with diabetes in the IMC. Data for this program were obtained from a de-identified disease registry and included 1312 outpatient IMC visits in adult patients with diabetes between March 2011 and September 2011. Collaborative depression care results in high rates of screening for and identification of depression, high rates of antidepressant utilization, and improved depression scores; however, more focused interventions are needed to improve diabetes outcomes in patients with depression and diabetes. The results indicate that the multidisciplinary IMC staff can work together with patients to identify and monitor depression within primary care. This study provides valuable information about models of depression care that can be implemented and evaluated in a clinical setting. ©2014 American Association of Nurse Practitioners.

Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists.

PubMed

Griffith, Niesha; McBride, Ali; Stevenson, James G; Green, Larry

2014-10-01

Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions' information technology systems.

Objective structured clinical examination for pharmacy students in Qatar: cultural and contextual barriers to assessment.

PubMed

Wilby, K J; Black, E K; Austin, Z; Mukhalalati, B; Aboulsoud, S; Khalifa, S I

2016-07-10

This study aimed to evaluate the feasibility and psychometric defensibility of implementing a comprehensive objective structured clinical examination (OSCE) on the complete pharmacy programme for pharmacy students in a Middle Eastern context, and to identify facilitators and barriers to implementation within new settings. Eight cases were developed, validated, and had standards set according to a blueprint, and were assessed with graduating pharmacy students. Assessor reliability was evaluated using inter-class coefficients (ICCs). Concurrent validity was evaluated by comparing OSCE results to professional skills course grades. Field notes were maintained to generate recommendations for implementation in other contexts. The examination pass mark was 424 points out of 700 (60.6%). All 23 participants passed. Mean performance was 74.6%. Low to moderate inter-rater reliability was obtained for analytical and global components (average ICC 0.77 and 0.48, respectively). In conclusion, OSCE was feasible in Qatar but context-related validity and reliability concerns must be addressed prior to future iterations in Qatar and elsewhere.

Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists

PubMed Central

McBride, Ali; Stevenson, James G.; Green, Larry

2014-01-01

Abstract Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions’ information technology systems. PMID:25477613

Application of new WAIS-III/WMS-III discrepancy scores for evaluating memory functioning: relationship between intellectual and memory ability.

PubMed

Lange, Rael T; Chelune, Gordon J

2006-05-01

Analysis of the discrepancy between memory and intellectual ability has received some support as a means for evaluating memory impairment. Recently, comprehensive base rate tables for General Ability Index (GAI) minus memory discrepancy scores (i.e., GAI-memory) were developed using the WAIS-III/WMS-III standardization sample (Lange, Chelune, & Tulsky, in press). The purpose of this study was to evaluate the clinical utility of GAI-memory discrepancy scores to identify memory impairment in 34 patients with Alzheimer's type dementia (DAT) versus a sample of 34 demographically matched healthy participants. On average, patients with DAT obtained significantly lower scores on all WAIS-III and WMS-III indexes and had larger GAI-memory discrepancy scores. Clinical outcome analyses revealed that GAI-memory scores were useful at identifying memory impairment in patients with DAT versus matched healthy participants. However, GAI-memory discrepancy scores failed to provide unique interpretive information beyond that which is gained from the memory indexes alone. Implications and future research directions are discussed.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials.

PubMed

Fouad, Mona N; Acemgil, Aras; Bae, Sejong; Forero, Andres; Lisovicz, Nedra; Martin, Michelle Y; Oates, Gabriela R; Partridge, Edward E; Vickers, Selwyn M

2016-06-01

Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute-designated comprehensive cancer center. Lay individuals were hired and trained to serve as PNs for clinical trials. African American patients potentially eligible for clinical trials were identified through chart review or referrals by clinic nurses, physicians, and social workers. PNs provided two levels of services: education about clinical trials and tailored support for patients who enrolled in clinical trials. Between 2007 and 2014, 424 African American patients with cancer were referred to the Increasing Minority Participation in Clinical Trials project. Of those eligible for a clinical trial (N = 378), 304 (80.4%) enrolled in a trial and 272 (72%) consented to receive patient navigation support. Of those receiving patient navigation support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support. The difference in retention rates between the two groups was statistically significant (P < .001). Participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%. Patient navigation for clinical trials successfully retained African Americans in therapeutic trials compared with non-patient navigation trial participation. The model holds promise as a strategy to reduce disparities in cancer clinical trial participation. Future studies should evaluate it with racial/ethnic minorities across cancer centers. Copyright © 2016 by American Society of Clinical Oncology.

Influences on self-evaluation during a clinical skills programme for nurses.

PubMed

Yeo, J; Steven, A; Pearson, P; Price, C

2010-05-01

Education has moved from teacher to student-centred practices. Increasing emphasis is placed on 'life-long' learning in the context of a rapidly changing knowledge base. Self-evaluation is seen as one strategy to facilitate student-centred continuous professional development. The literature, however, suggests that learners' ability to self-assess is mixed, and little is known regarding how students perform self-assessment. This study focussed on senior nurses undertaking a scenario-based clinical skills course. Learners were asked to self-evaluate several times during the course. This research explored the influences on using the self-evaluation exercise. The study drew upon grounded theory methodology and was influenced by constructionist and postmodernist theories. Three methods of data collection were used: semi-structured interviews, observation of supervision sessions and recording of the numerical self-evaluation ratings. Multiple interviews with students (n = 14) and the educational supervisor (n = 1) were conducted. Thematic analysis and data collection were conducted iteratively. The study found that feeling confident and stating that confidence were not necessarily the same. Feeling confident was complex, influenced by changing perceptions of clinical skills and credibility. Changing frames of reference were used to judge feelings of confidence. Stating confidence appeared to be socially negotiated, influenced by social acceptability considerations such as modesty and the need to show progress over time. The discourses of empowerment and surveillance were influential and self-evaluation is discussed using Foucault's theory of governmentality, illustrating how learners can be both empowered and controlled through self-evaluation. Further consideration of the socially constructed nature of self-evaluations would benefit both educational practice and future research.

Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes.

PubMed

Sakamoto, Shinji; Takaki, Manabu; Okahisa, Yuko; Mizuki, Yutaka; Inagaki, Masatoshi; Ujike, Hiroshi; Mitsuhashi, Toshiharu; Takao, Soshi; Ikeda, Masashi; Uchitomi, Yosuke; Iwata, Nakao; Yamada, Norihito

2016-04-01

Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study.

2014 consensus statement from the first Economics of Physical Inactivity Consensus (EPIC) conference (Vancouver).

PubMed

Davis, Jennifer C; Verhagen, Evert; Bryan, Stirling; Liu-Ambrose, Teresa; Borland, Jeff; Buchner, David; Hendriks, Marike R C; Weiler, Richard; Morrow, James R; van Mechelen, Willem; Blair, Steven N; Pratt, Mike; Windt, Johann; al-Tunaiji, Hashel; Macri, Erin; Khan, Karim M

2014-06-01

This article describes major topics discussed from the 'Economics of Physical Inactivity Consensus Workshop' (EPIC), held in Vancouver, Canada, in April 2011. Specifically, we (1) detail existing evidence on effective physical inactivity prevention strategies; (2) introduce economic evaluation and its role in health policy decisions; (3) discuss key challenges in establishing and building health economic evaluation evidence (including accurate and reliable costs and clinical outcome measurement) and (4) provide insight into interpretation of economic evaluations in this critically important field. We found that most methodological challenges are related to (1) accurately and objectively valuing outcomes; (2) determining meaningful clinically important differences in objective measures of physical inactivity; (3) estimating investment and disinvestment costs and (4) addressing barriers to implementation. We propose that guidelines specific for economic evaluations of physical inactivity intervention studies are developed to ensure that related costs and effects are robustly, consistently and accurately measured. This will also facilitate comparisons among future economic evidence. 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.

Assessment of the feasibility and clinical value of further research to evaluate the management options for children with Down syndrome and otitis media with effusion: a feasibility study.

PubMed

Fortnum, Heather; Leighton, Paul; Smith, Murray D; Brown, Lisa; Jones, Matthew; Benton, Claire; Marder, Elizabeth; Marshall, Andrew; Sutton, Kate

2014-09-01

There is clinical uncertainty of the benefits and costs of different treatment options for children with Down syndrome who have glue ear. This study was designed to assess the extent of this lack of knowledge and determine if pursuing further information would be practical, beneficial and cost-effective. To assess the level and practical effect of current uncertainty around treatment options for children with Down syndrome and glue ear. To assess the feasibility of studying the options for management of glue ear in children with Down syndrome via a randomised controlled trial (RCT) or multicentre prospective cohort study by evaluating the willingness of (1) parents to agree to randomisation for their children and (2) clinicians to recruit participants to a definitive study. To undertake value of information analyses to demonstrate the potential economic benefit from undertaking further research. A feasibility study exploring the views of parents of children with Down syndrome and professionals who have responsibility for the health and education of children with Down syndrome, on the participation in, and value of, future research into interventions for glue ear. Data were collected from parents via self-completed questionnaires, face-to-face interviews and focus groups and from professionals via online questionnaires and a Delphi review exercise. Development of economic models to represent clinical pathways of care and a RCT informed a value of information (VOI) analysis. UK (professionals); East Midlands region of the UK (parents). Parents of children aged 1-11 years with Down syndrome (n = 156). Professionals including audiologists, ear, nose and throat surgeons, audiological physicians, speech and language therapists, and teachers of the deaf (n = 128). Quantitative and qualitative data on parental views and experiences of glue ear and its effects; interventions and treatment received; taking part in research and factors that would encourage or discourage participation; and the importance of various outcome domains to them and for their children. For professionals: information on caseloads; approaches to clinical management; opinions on frequency and significance of the consequences of glue ear for this population; importance of different outcome measures; opinions of interventions and their role in future research; views on health research; facilitators and barriers to recruitment, and participation in research involving RCTs. The complexity of the experience and individual characteristics of children with Down syndrome poses challenges for the design of any future research but these challenges were not considered by professionals to raise sufficient barriers to prevent it being undertaken. Parents were generally supportive of the need for, and value of, research but identified practical and emotional issues that would need addressing. Glue ear was considered to impact more on speech, language and communication than on hearing. Outcome measures for future research would need to evaluate these elements but measures should be designed specifically for the population. Parents and professionals identified randomisation as a significant barrier to participation. The VOI analyses identified lack of data as problematic but concluded that a future trial involving surgical intervention would be feasible at costs of < £650,000. Future research into the benefits of interventions for glue ear in children with Down syndrome would be feasible and could be cost-effective but should be carefully designed to facilitate and maximise participation from parents and professionals responsible for recruitment. The National Institute for Health Research Health Technology Assessment programme.

OR.NET: multi-perspective qualitative evaluation of an integrated operating room based on IEEE 11073 SDC.

PubMed

Rockstroh, M; Franke, S; Hofer, M; Will, A; Kasparick, M; Andersen, B; Neumuth, T

2017-08-01

Clinical working environments have become very complex imposing many different tasks in diagnosis, medical treatment, and care procedures. During the German flagship project OR.NET, more than 50 partners developed technologies for an open integration of medical devices and IT systems in the operating room. The aim of the present work was to evaluate a large set of the proposed concepts from the perspectives of various stakeholders. The demonstration OR is focused on interventions from the head and neck surgery and was developed in close cooperation with surgeons and numerous colleagues of the project partners. The demonstration OR was qualitatively evaluated including technical as well as clinical aspects. In the evaluation, a questionnaire was used to obtain feedback from hospital operators. The clinical implications were covered by structured interviews with surgeons, anesthesiologists and OR staff. In the present work, we qualitatively evaluate a subset of the proposed concepts from the perspectives of various stakeholders. The feedback of the clinicians indicates that there is a need for a flexible data and control integration. The hospital operators stress the need for tools to simplify risk management in openly integrated operating rooms. The implementation of openly integrated operating rooms will positively affect the surgeons, the anesthesiologists, the surgical nursing staff, as well as the technical personnel and the hospital operators. The evaluation demonstrated the need for OR integration technologies and identified the missing tools to support risk management and approval as the main barriers for future installments.

Evaluation of Psychology Clinicians' Attitudes towards Computerized Cognitive Behavior Therapy, for Use in Their Future Clinical Practice, with Regard to Treating Those Suffering from Anxiety and Depression

ERIC Educational Resources Information Center

Dunne, Nivek

2017-01-01

Computerized Cognitive Behavioural Therapy (CCBT) is an empirically supported therapeutic modality used in the treatment of anxiety and depression. It is an important area of research considering there is much research lacking in this area, especially regarding trainee and qualified psychology clinicians' attitudes which are informative in terms…

Penicillin allergy: optimizing diagnostic protocols, public health implications, and future research needs.

PubMed

Macy, Eric

2015-08-01

Unverified penicillin allergy is being increasingly recognized as a public health concern. The ideal protocol for verifying true clinically significant IgE-mediated penicillin allergy needs to use only commercially available materials, be well tolerated and easy to perform in both the inpatient and outpatient settings, and minimize false-positive determinations. This review concentrates on articles published in 2013 and 2014 that present new data relating to the diagnosis and management of penicillin allergy. Penicillin allergy can be safely evaluated at this time, in patients with an appropriate clinical history of penicillin allergy, using only penicilloyl-poly-lysine and native penicillin G as skin test reagents, if an oral challenge with amoxicillin 250 mg, followed by 1 h of observation, is given to all skin test negative individuals. Millions of individuals falsely labeled with penicillin allergy need to be evaluated to safely allow them to use penicillin-class antibiotics and avoid morbidity associated with penicillin avoidance. Further research is needed to determine optimal protocol(s). There will still be a 1-2% rate of adverse reactions reported with all future therapeutic penicillin-class antibiotic use, even with optimal methods used to determine acute penicillin tolerance. Only a small minority of these new reactions will be IgE-mediated.

Health economic evaluation of treatments for Alzheimer's disease: impact of new diagnostic criteria.

PubMed

Wimo, A; Ballard, C; Brayne, C; Gauthier, S; Handels, R; Jones, R W; Jonsson, L; Khachaturian, A S; Kramberger, M

2014-03-01

The socio-economic impact of Alzheimer's disease (AD) and other dementias is enormous, and the potential economic challenges ahead are clear given the projected future numbers of individuals with these conditions. Because of the high prevalence and cost of dementia, it is very important to assess any intervention from a cost-effectiveness viewpoint. The diagnostic criteria for preclinical AD suggested by the National Institute on Aging and Alzheimer's Association workgroups in combination with the goal of effective disease-modifying treatment (DMT) are, however, a challenge for clinical practice and for the design of clinical trials. Key issues for future cost-effectiveness studies include the following: (i) the consequences for patients if diagnosis is shifted from AD-dementia to predementia states, (ii) bridging the gap between clinical trial populations and patients treated in clinical practice, (iii) translation of clinical trial end-points into measures that are meaningful to patients and policymakers/payers and (iv) how to measure long-term effects. To improve cost-effectiveness studies, long-term population-based data on disease progression, costs and outcomes in clinical practice are needed not only in dementia but also in predementia states. Reliable surrogate end-points in clinical trials that are sensitive to detect effects even in predementia states are also essential as well as robust and validated modelling methods from predementia states that also take into account comorbidities and age. Finally, the ethical consequences of early diagnosis should be considered. © 2014 The Association for the Publication of the Journal of Internal Medicine.

Clinical Findings and Pain Symptoms as Potential Risk Factors for Chronic TMD: Descriptive Data and Empirically Identified Domains from the OPPERA Case-Control Study

PubMed Central

Ohrbach, Richard; Fillingim, Roger B.; Mulkey, Flora; Gonzalez, Yoly; Gordon, Sharon; Gremillion, Henry; Lim, Pei-Feng; Ribeiro-Dasilva, Margarete; Greenspan, Joel D.; Knott, Charles; Maixner, William; Slade, Gary

2011-01-01

Clinical characteristics might be associated with temporomandibular disorders (TMD) because they are antecedent risk factors that increase the likelihood of a healthy person developing the condition or because they represent signs or symptoms of either subclinical or overt TMD. In this baseline case-control study of the multisite Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA) project, 1,633 controls and 185 cases with chronic, painful TMD completed questionnaires and received clinical examinations. Odds ratios measuring association between each clinical factor and TMD were computed, with adjustment for study-site as well as age, sex, and race/ethnicity. Compared to controls, TMD cases reported more trauma, greater parafunction, more headaches and other pain disorders, more functional limitation in using the jaw, more nonpain symptoms in the facial area, more temporomandibular joint noises and jaw locking, more neural or sensory medical conditions, and worse overall medical status. They also exhibited on examination reduced jaw mobility, more joint noises, and a greater number of painful masticatory, cervical, and body muscles upon palpation. The results indicated that TMD cases differ substantially from controls across almost all variables assessed. Future analyses of follow-up data will determine whether these clinical characteristics predict increased risk for developing first-onset pain-related TMD Perspective Clinical findings from OPPERA’s baseline case-control study indicate significant differences between chronic TMD cases and controls with respect to trauma history, parafunction, other pain disorders, health status, and clinical examination data. Future analyses will examine their contribution to TMD onset. PMID:22074750

Instruments evaluating the quality of the clinical learning environment in nursing education: A systematic review of psychometric properties.

PubMed

Mansutti, Irene; Saiani, Luisa; Grassetti, Luca; Palese, Alvisa

2017-03-01

The clinical learning environment is fundamental to nursing education paths, capable of affecting learning processes and outcomes. Several instruments have been developed in nursing education, aimed at evaluating the quality of the clinical learning environments; however, no systematic review of the psychometric properties and methodological quality of these studies has been performed to date. The aims of the study were: 1) to identify validated instruments evaluating the clinical learning environments in nursing education; 2) to evaluate critically the methodological quality of the psychometric property estimation used; and 3) to compare psychometric properties across the instruments available. A systematic review of the literature (using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines) and an evaluation of the methodological quality of psychometric properties (using the COnsensus-based Standards for the selection of health Measurement INstruments guidelines). The Medline and CINAHL databases were searched. Eligible studies were those that satisfied the following criteria: a) validation studies of instruments evaluating the quality of clinical learning environments; b) in nursing education; c) published in English or Italian; d) before April 2016. The included studies were evaluated for the methodological quality of the psychometric properties measured and then compared in terms of both the psychometric properties and the methodological quality of the processes used. The search strategy yielded a total of 26 studies and eight clinical learning environment evaluation instruments. A variety of psychometric properties have been estimated for each instrument, with differing qualities in the methodology used. Concept and construct validity were poorly assessed in terms of their significance and rarely judged by the target population (nursing students). Some properties were rarely considered (e.g., reliability, measurement error, criterion validity), whereas others were frequently estimated, but using different coefficients and statistical analyses (e.g., internal consistency, structural validity), thus rendering comparison across instruments difficult. Moreover, the methodological quality adopted in the property assessments was poor or fair in most studies, compromising the goodness of the psychometric values estimated. Clinical learning placements represent the key strategies in educating the future nursing workforce: instruments evaluating the quality of the settings, as well as their capacity to promote significant learning, are strongly recommended. Studies estimating psychometric properties, using an increased quality of research methodologies are needed in order to support nursing educators in the process of clinical placements accreditation and quality improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

Using reusable learning objects (rlos) in injection skills teaching: Evaluations from multiple user types.

PubMed

Williams, Julia; O'Connor, Mórna; Windle, Richard; Wharrad, Heather J

2015-12-01

Clinical skills are a critical component of pre-registration nurse education in the United Kingdom, yet there is widespread concern about the clinical skills displayed by newly-qualified nurses. Novel means of supporting clinical skills education are required to address this. A package of Reusable Learning Objects (RLOs) was developed to supplement pre-registration teaching on the clinical skill of administering injection medication. RLOs are electronic resources addressing a single learning objective whose interactivity facilitates learning. This article evaluates a package of five injection RLOs across three studies: (1) questionnaires administered to pre-registration nursing students at University of Nottingham (UoN) (n=46) evaluating the RLO package as a whole; (2) individual RLOs evaluated in online questionnaires by educators and students from UoN; from other national and international institutions; and healthcare professionals (n=265); (3) qualitative evaluation of the RLO package by UoN injection skills tutors (n=6). Data from all studies were assessed for (1) access to, (2) usefulness, (3) impact and (4) integration of the RLOs. Study one found that pre-registration nursing students rate the RLO package highly across all categories, particularly underscoring the value of their self-test elements. Study two found high ratings in online assessments of individual RLOs by multiple users. The global reach is particularly encouraging here. Tutors reported insufficient levels of student-RLO access, which might be explained by the timing of their student exposure. Tutors integrate RLOs into teaching and agree on their use as teaching supplements, not substitutes for face-to-face education. This evaluation encompasses the first years postpackage release. Encouraging data on evaluative categories in this early review suggest that future evaluations are warranted to track progress as the package is adopted and evaluated more widely. Copyright © 2015 Elsevier Ltd. All rights reserved.

TIA Management

PubMed Central

Mijalski, Christina

2015-01-01

Transient ischemic attack (TIA) has gained increasing attention over the last 2 decades with the realization that the condition is common, portends potentially serious consequences, and, when identified early, can be evaluated and treated to modify future risk. In this review, we examine the issues of whether all TIA patients need admission and whether such patients should receive short-term dual antiplatelet therapy. Not all patients require admission if evaluation and treatment are done promptly. There may be a role for dual antiplatelet therapy, but the results of further clinical trials will help provide better clarity on which patients are the best candidates for this treatment. PMID:26288673

Application of Model Animals in the Study of Drug Toxicology

NASA Astrophysics Data System (ADS)

Song, Yagang; Miao, Mingsan

2018-01-01

Drug safety is a key factor in drug research and development, Drug toxicology test is the main method to evaluate the safety of drugs, The body condition of an animal has important implications for the results of the study, Previous toxicological studies of drugs were carried out in normal animals in the past, There is a great deviation from the clinical practice.The purpose of this study is to investigate the necessity of model animals as a substitute for normal animals for toxicological studies, It is expected to provide exact guidance for future drug safety evaluation.

Commentary: Factors predicting family court decisions in high-conflict divorce.

PubMed

Stover, Carla Smith

2013-01-01

Factors that predict custody and visitation decisions are an important area of research, especially in the context of high-conflict divorce. In these cases, youths are at significantly higher risk for exposure to ongoing conflict, violence, and triangulation in their parents' disputes. What variables courts and evaluation clinics use to make custody decisions and whether they are the most salient requires further study. The work by Raub and colleagues in this issue extends our understanding of important factors considered by the courts and custody evaluators in high-conflict divorce and points to directions for future research in this area.

Supportive Care Treatment Guidelines: Value, Limitations, and Opportunities

PubMed Central

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

2013-01-01

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

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement.

PubMed

Ruiz, Carlos E; Hahn, Rebecca T; Berrebi, Alain; Borer, Jeffrey S; Cutlip, Donald E; Fontana, Greg; Gerosa, Gino; Ibrahim, Reda; Jelnin, Vladimir; Jilaihawi, Hasan; Jolicoeur, E Marc; Kliger, Chad; Kronzon, Itzhak; Leipsic, Jonathon; Maisano, Francesco; Millan, Xavier; Nataf, Patrick; O'Gara, Patrick T; Pibarot, Philippe; Ramee, Stephen R; Rihal, Charanjit S; Rodes-Cabau, Josep; Sorajja, Paul; Suri, Rakesh; Swain, Julie A; Turi, Zoltan G; Tuzcu, E Murat; Weissman, Neil J; Zamorano, Jose L; Serruys, Patrick W; Leon, Martin B

2017-04-25

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted. Copyright © 2017 American College of Cardiology Foundation and European Society of Cardiology. Published by Elsevier Inc. All rights reserved.

18 F-Fluorodeoxyglucose-Positron Emission Tomography As an Imaging Biomarker in a Prospective, Longitudinal Cohort of Patients With Large Vessel Vasculitis.

PubMed

Grayson, Peter C; Alehashemi, Sara; Bagheri, Armin A; Civelek, Ali Cahid; Cupps, Thomas R; Kaplan, Mariana J; Malayeri, Ashkan A; Merkel, Peter A; Novakovich, Elaine; Bluemke, David A; Ahlman, Mark A

2018-03-01

To assess the clinical value of 18 F-fluorodeoxyglucose (FDG) positron emission tomography (PET) in a prospective cohort of patients with large vessel vasculitis (LVV) and comparator subjects. Patients with Takayasu arteritis and giant cell arteritis were studied, along with a comparator group consisting of patients with hyperlipidemia, patients with diseases that mimic LVV, and healthy controls. Participants underwent clinical evaluation and FDG-PET imaging, and patients with LVV underwent serial imaging at 6-month intervals. We calculated sensitivity and specificity of FDG-PET interpretation for distinguishing patients with clinically active LVV from comparator subjects and from patients with disease in clinical remission. A qualitative summary score based on global arterial FDG uptake, the PET Vascular Activity Score (PETVAS), was used to study associations between activity on PET scan and clinical characteristics and to predict relapse. A total of 170 FDG-PET scans were performed in 115 participants (56 patients with LVV and 59 comparator subjects). FDG-PET distinguished patients with clinically active LVV from comparator subjects with a sensitivity of 85% (95% confidence interval [95% CI] 69, 94) and a specificity of 83% (95% CI 71, 91). FDG-PET scans were interpreted as active vasculitis in most patients with LVV in clinical remission (41 of 71 [58%]). Clinical disease activity status, disease duration, body mass index, and glucocorticoid use were independently associated with activity on PET scan. Among patients who underwent PET during clinical remission, future clinical relapse was more common in patients with a high PETVAS than in those with a low PETVAS (55% versus 11%; P = 0.03) over a median follow-up period of 15 months. FDG-PET provides information about vascular inflammation that is complementary to, and distinct from, clinical assessment in LVV. FDG-PET scan activity during clinical remission was associated with future clinical relapse. © 2017, American College of Rheumatology.

Perceived preparedness for physiatric specialization and future career goals of graduating postgraduate year IV residents during the 2004-2005 academic year.

PubMed

Raj, Vishwa S; Rintala, Diana H

2007-12-01

The purpose of this study was to evaluate trends among postgraduate year (PGY) IV physiatry residents, at the time of graduation from residency, in terms of their perceived experiences in the core clinical areas, confidence with procedural subspecialization, choice in career specialization, and desire to pursue clinical fellowship. Surveys were distributed to 386 PGY IV residents in physiatry at the end of the 2004-2005 academic year. Ninety-three residents (24%) completed responses in a confidential manner. Residents who were generally more confident in core clinical areas, as defined by the Self-Assessment Examination, and specialty prescription writing also believed themselves to be more prepared to practice these topics in their careers. Overall levels of confidence and perceived preparedness correlated positively with months of training and negatively with the belief in the need for postresidency fellowship training to incorporate these areas into clinical practice. Positive correlations also existed among perceived levels of preparedness in performing various physiatric procedures. Statistically significant differences in levels of confidence and preparedness existed among geographic regions when evaluating core physiatric subject matter. Fifty-six percent of residents who responded planned to pursue fellowship training, and a majority of residents intended to perform interventional procedures and musculoskeletal medicine in their practices. These results provide insight into how trainees perceive their current clinical education. With validation of measures for confidence and preparedness, this survey may be useful as an adjunct resource for residency programs to evaluate their trainees.

ILCOR Scientific Knowledge Gaps and Clinical Research Priorities for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: A Consensus Statement.

PubMed

Kleinman, Monica E; Perkins, Gavin D; Bhanji, Farhan; Billi, John E; Bray, Janet E; Callaway, Clifton W; de Caen, Allan; Finn, Judith C; Hazinski, Mary Fran; Lim, Swee Han; Maconochie, Ian; Morley, Peter; Nadkarni, Vinay; Neumar, Robert W; Nikolaou, Nikolaos; Nolan, Jerry P; Reis, Amelia; Sierra, Alfredo F; Singletary, Eunice M; Soar, Jasmeet; Stanton, David; Travers, Andrew; Welsford, Michelle; Zideman, David

2018-04-26

Despite significant advances in the field of resuscitation science, important knowledge gaps persist. Current guidelines for resuscitation are based on the International Liaison Committee on Resuscitation 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations, which includes treatment recommendations supported by the available evidence. The writing group developed this consensus statement with the goal of focusing future research by addressing the knowledge gaps identified during and after the 2015 International Liaison Committee on Resuscitation evidence evaluation process. Key publications since the 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations are referenced, along with known ongoing clinical trials that are likely to affect future guidelines. © 2018 European Resuscitation Council and American Heart Association, Inc. Published by Elsevier B.V. All rights reserved. Copyright © 2018 European Resuscitation Council and American Heart Association, Inc. Published by Elsevier B.V. All rights reserved.

Are Genetic Tests for Atherosclerosis Ready for Routine Clinical Use?

PubMed

Paynter, Nina P; Ridker, Paul M; Chasman, Daniel I

2016-02-19

In this review, we lay out 3 areas currently being evaluated for incorporation of genetic information into clinical practice related to atherosclerosis. The first, familial hypercholesterolemia, is the clearest case for utility of genetic testing in diagnosis and potentially guiding treatment. Already in use for confirmatory testing of familial hypercholesterolemia and for cascade screening of relatives, genetic testing is likely to expand to help establish diagnoses and facilitate research related to most effective therapies, including new agents, such as PCSK9 inhibitors. The second area, adding genetic information to cardiovascular risk prediction for primary prevention, is not currently recommended. Although identification of additional variants may add substantially to prediction in the future, combining known variants has not yet demonstrated sufficient improvement in prediction for incorporation into commonly used risk scores. The third area, pharmacogenetics, has utility for some therapies today. Future utility for pharmacogenetics will wax or wane depending on the nature of available drugs and therapeutic strategies. © 2016 American Heart Association, Inc.

Towards an Immunophenotype of Schizophrenia: Progress, Potential Mechanisms, and Future Directions

PubMed Central

Miller, Brian J; Goldsmith, David R

2017-01-01

The evidence to date, coupled with advances in immunology and genetics has afforded the field an unparalleled opportunity to investigate the hypothesis that a subset of patients with schizophrenia may manifest an immunophenotype, toward new potential diagnostics and therapeutics to reduce risk, alleviate symptoms, and improve quality of life in both at-risk populations and patients with established schizophrenia. In this paper, we will first summarize the findings on immune dysfunction in schizophrenia, including (1) genetic, prenatal, and premorbid immune risk factors and (2) immune markers across the clinical course of the disorder, including cytokines; C-reactive protein; immune cells; antibodies, autoantibodies and comorbid autoimmune disorders; complement; oxidative stress; imaging of neuroinflammation; infections; and clinical trials of anti-inflammatory agents and immunotherapy. We will then discuss a potential mechanistic framework toward increased understanding of a potential schizophrenia immunophenotype. We will then critically appraise the existing literature, and discuss suggestions for the future research agenda in this area that are needed to rigorously evaluate this hypothesis. PMID:27654215

Muscular dystrophy in a family of Labrador Retrievers with no muscle dystrophin and a mild phenotype.

PubMed

Vieira, Natassia M; Guo, Ling T; Estrela, Elicia; Kunkel, Louis M; Zatz, Mayana; Shelton, G Diane

2015-05-01

Animal models of dystrophin deficient muscular dystrophy, most notably canine X-linked muscular dystrophy, play an important role in developing new therapies for human Duchenne muscular dystrophy. Although the canine disease is a model of the human disease, the variable severity of clinical presentations in the canine may be problematic for pre-clinical trials, but also informative. Here we describe a family of Labrador Retrievers with three generations of male dogs having markedly increased serum creatine kinase activity, absence of membrane dystrophin, but with undetectable clinical signs of muscle weakness. Clinically normal young male Labrador Retriever puppies were evaluated prior to surgical neuter by screening laboratory blood work, including serum creatine kinase activity. Serum creatine kinase activities were markedly increased in the absence of clinical signs of muscle weakness. Evaluation of muscle biopsies confirmed a dystrophic phenotype with both degeneration and regeneration. Further evaluations by immunofluorescence and western blot analysis confirmed the absence of muscle dystrophin. Although dystrophin was not identified in the muscles, we did not find any detectable deletions or duplications in the dystrophin gene. Sequencing is now ongoing to search for point mutations. Our findings in this family of Labrador Retriever dogs lend support to the hypothesis that, in exceptional situations, muscle with no dystrophin may be functional. Unlocking the secrets that protect these dogs from a severe clinical myopathy is a great challenge which may have important implications for future treatment of human muscular dystrophies. Copyright © 2015 Elsevier B.V. All rights reserved.

Patient-reported outcomes of pain and physical functioning in neurofibromatosis clinical trials.

PubMed

Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Tonsgard, James H; Solomon, Sondra E; Baldwin, Andrea; Bergner, Amanda L; Walsh, Karin; Thompson, Heather L; Gardner, Kathy L; Hingtgen, Cynthia M; Schorry, Elizabeth; Dudley, William N; Franklin, Barbara

2016-08-16

Tumors and other disease complications of neurofibromatosis (NF) can cause pain and negatively affect physical functioning. To document the clinical benefit of treatment in NF trials targeting these manifestations, patient-reported outcomes (PROs) assessing pain and physical functioning should be included as study endpoints. Currently, there is no consensus on the selection and use of such measures in the NF population. This article presents the recommendations of the PRO group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration for assessing the domains of pain and physical functioning for NF clinical trials. The REiNS PRO group reviewed and rated existing PRO measures assessing pain intensity, pain interference, and physical functioning using their systematic method. Final recommendations are based primarily on 4 main criteria: patient characteristics, item content, psychometric properties, and feasibility for clinical trials. The REiNS PRO group chose the Numeric Rating Scale-11 (≥8 years) to assess pain intensity, the Pain Interference Index (6-24 years) and the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale (≥18 years) to evaluate pain interference, and the PROMIS Physical Functioning Scale to measure upper extremity function and mobility (≥5 years) for NF clinical trials. The REiNS Collaboration currently recommends these PRO measures to assess the domains of pain and physical functioning for NF clinical trials; however, further research is needed to evaluate their use in individuals with NF. A final consensus recommendation for the pain interference measure will be disseminated in a future publication based on findings from additional published research. © 2016 American Academy of Neurology.

Fall risk: the clinical relevance of falls and how to integrate fall risk with fracture risk.

PubMed

Peeters, G; van Schoor, Natasja M; Lips, Paul

2009-12-01

In old age, 5-10% percent of all falls result in a fracture, and up to 90% of all fractures result from a fall. This article describes the link between fall risk and fracture risk in community-dwelling older persons. Which factors attribute to both the fall risk and the fracture risk? Which falls result in a fracture? Which tools are available to predict falls and fractures? Directions for the use of prediction tools in clinical practice are given. Challenges for future research include further validation of existing prediction tools and evaluation of the cost-effectiveness of treatment after screening.

Development of a combined OCT-Raman probe for the prospective in vivo clinical melanoma skin cancer screening

NASA Astrophysics Data System (ADS)

Mazurenka, M.; Behrendt, L.; Meinhardt-Wollweber, M.; Morgner, U.; Roth, B.

2017-10-01

A combined optical coherence tomography (OCT)-Raman probe was designed and built into a spectral domain OCT head, and its performance was evaluated and compared to the most common Raman probe setups, based on a fiber bundle and confocal free space optics. Due to the use of the full field of view of an OCT scanning lens, the combined probe has a superior performance within maximum permissible exposure limits, compared to the other two probes. Skin Raman spectra, recorded in vivo, further prove the feasibility of the OCT-Raman probe for the future in vivo clinical applications in skin cancer screening.

PCR examination of bronchoalveolar lavage samples is a useful tool in pre-clinical diagnosis of ovine pulmonary adenocarcinoma (Jaagsiekte).

PubMed

Voigt, K; Brügmann, M; Huber, K; Dewar, P; Cousens, C; Hall, M; Sharp, J M; Ganter, M

2007-12-01

Ovine pulmonary adenocarcinoma (OPA) is a contagious lung tumour of sheep caused by Jaagsiekte sheep retrovirus (JSRV). The disease is a particular problem in flocks in many parts of the world. The aim of the study was to assess screening methods for individual animals as a prelude to future eradication trials. Results of histological examination were used as the standard to evaluate the relative sensitivity and specificity of an established heminested polymerase chain reaction (PCR) test for JSRV proviral DNA from blood and bronchoalveolar lavage (BAL) samples. PCR results from tissue samples are included as control data. PCR testing of blood samples was found to have an estimated sensitivity of only 10% (95% confidence interval (CI) 3-20) while the sensitivity of the PCR test on BAL samples was 89% (CI 79-96) in comparison to the results of histological examination. We conclude that PCR testing of BAL samples is an effective confirmatory test for sheep with suspected clinical OPA. It is also a useful tool for the pre-clinical identification of individual infected sheep within an infected flock and therefore may prove beneficial in future control or eradication programmes.

Management of refractory anti-phospholipid syndrome.

PubMed

Scoble, Tina; Wijetilleka, Sonali; Khamashta, Munther A

2011-09-01

Anti-phospholipid syndrome (APS) is an autoimmune prothrombotic disorder characterised by the predisposition to venous and/or arterial thrombosis and obstetric morbidity. Management of APS centres on attenuating the procoagulant state whilst balancing the risks of anticoagulant therapy. Cases of recurrent thromboses and obstetric complications occur despite optimum therapy. Alternative therapies for refractory cases are subject to disparity among clinicians due to the current lack of clinical evidence present. This review aims to address the current management strategies for refractory thrombotic and obstetric cases and future therapeutic interventions. The role and current clinical evidence of using long term low molecular weight heparin (LMWH) as an alternative to warfarin therapy for refractory thromboses is evaluated. Potential alternatives for thromboses including statins, hydroxychloroquine, Rituximab are reviewed as well as the additional avenues to target in the future as the pathogenic mechanisms of APS are unveiled. The optimal management for refractory obstetric APS cases is subject to controversy. This review focuses and assesses the current evidence for the uses of low dose prednisolone, intravenous immunoglobulin and hydroxycholoroquine in obstetric cases. The treatment modalities for the management of refractory APS require further clinical evidence. Copyright © 2011 Elsevier B.V. All rights reserved.

Evidence-based clinical policy: case report of a reproducible process to encourage understanding and evaluation of evidence.

PubMed

Rikard-Bell, G; Waters, E; Ward, J

2006-07-01

We report within a case study a reproducible process to facilitate the explicit incorporation of evidence by a multidisciplinary group into clinical policy development. To support the decision-making of a multidisciplinary Intersectoral Advisory Group (IAG) convened by the Royal Australasian College of Physicians Health Policy Unit, a systematic review of randomized controlled trials about environmental tobacco smoke and smoking cessation interventions in paediatric settings was first undertaken. As reported in detail here, IAG members were then formally engaged in a transparent and replicable process to understand and interpret the synthesized evidence and to proffer their independent reactions regarding policy, practice and research. Our intention was to ensure that all IAG members were democratically engaged and made aware of the available evidence. As clinical policy must engage stakeholder representatives from diverse backgrounds, a process to equalize understanding of the evidence and 'democratize' judgment about its implications is needed. Future research must then examine the benefits of such explicit steps when guidelines, in turn, are implemented. We hypothesize that changes to future practice will be more likely if processes undertaken to develop guidelines are transparent to clinicians and other target groups.

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.

VTE Risk assessment - a prognostic Model: BATER Cohort Study of young women.

PubMed

Heinemann, Lothar Aj; Dominh, Thai; Assmann, Anita; Schramm, Wolfgang; Schürmann, Rolf; Hilpert, Jan; Spannagl, Michael

2005-04-18

BACKGROUND: Community-based cohort studies are not available that evaluated the predictive power of both clinical and genetic risk factors for venous thromboembolism (VTE). There is, however, clinical need to forecast the likelihood of future occurrence of VTE, at least qualitatively, to support decisions about intensity of diagnostic or preventive measures. MATERIALS AND METHODS: A 10-year observation period of the Bavarian Thromboembolic Risk (BATER) study, a cohort study of 4337 women (18-55 years), was used to develop a predictive model of VTE based on clinical and genetic variables at baseline (1993). The objective was to prepare a probabilistic scheme that discriminates women with virtually no VTE risk from those at higher levels of absolute VTE risk in the foreseeable future. A multivariate analysis determined which variables at baseline were the best predictors of a future VTE event, provided a ranking according to the predictive power, and permitted to design a simple graphic scheme to assess the individual VTE risk using five predictor variables. RESULTS: Thirty-four new confirmed VTEs occurred during the observation period of over 32,000 women-years (WYs). A model was developed mainly based on clinical information (personal history of previous VTE and family history of VTE, age, BMI) and one composite genetic risk markers (combining Factor V Leiden and Prothrombin G20210A Mutation). Four levels of increasing VTE risk were arbitrarily defined to map the prevalence in the study population: No/low risk of VTE (61.3%), moderate risk (21.1%), high risk (6.0%), very high risk of future VTE (0.9%). In 10.6% of the population the risk assessment was not possible due to lacking VTE cases. The average incidence rates for VTE in these four levels were: 4.1, 12.3, 47.2, and 170.5 per 104 WYs for no, moderate, high, and very high risk, respectively. CONCLUSION: Our prognostic tool - containing clinical information (and if available also genetic data) - seems to be worthwhile testing in medical practice in order to confirm or refute the positive findings of this study. Our cohort study will be continued to include more VTE cases and to increase predictive value of the model.

A Pilot Evaluation of On-Road Detection Performance by Drivers with Hemianopia Using Oblique Peripheral Prisms

PubMed Central

Bowers, Alex R.; Tant, Mark; Peli, Eli

2012-01-01

Aims. Homonymous hemianopia (HH), a severe visual consequence of stroke, causes difficulties in detecting obstacles on the nonseeing (blind) side. We conducted a pilot study to evaluate the effects of oblique peripheral prisms, a novel development in optical treatments for HH, on detection of unexpected hazards when driving. Methods. Twelve people with complete HH (median 49 years, range 29–68) completed road tests with sham oblique prism glasses (SP) and real oblique prism glasses (RP). A masked evaluator rated driving performance along the 25 km routes on busy streets in Ghent, Belgium. Results. The proportion of satisfactory responses to unexpected hazards on the blind side was higher in the RP than the SP drive (80% versus 30%; P = 0.001), but similar for unexpected hazards on the seeing side. Conclusions. These pilot data suggest that oblique peripheral prisms may improve responses of people with HH to blindside hazards when driving and provide the basis for a future, larger-sample clinical trial. Testing responses to unexpected hazards in areas of heavy vehicle and pedestrian traffic appears promising as a real-world outcome measure for future evaluations of HH rehabilitation interventions aimed at improving detection when driving. PMID:23316415

Recent advances in anti-neutrophil cytoplasmic antibody-associated vasculitis

PubMed Central

Lazarus, B.; John, G. T.; O’Callaghan, C.; Ranganathan, D.

2016-01-01

Anti-neutrophil cytoplasmic antibody-associated vasculitis is an uncommon inflammatory disease of small to medium-sized vessels that frequently presents with rapidly progressive glomerulonephritis and renal failure though it can affect any organ system. If untreated, the vast majority of patients will die within a year. Current treatments improve prognosis but affected patients remain at a substantially higher risk of death and adverse outcomes. We review the classification of the disease, our understanding of the pathogenesis and epidemiology, and propose future directions for research. We also evaluate the evidence supporting established treatment regimens and the progress of clinical trials for newer treatments to inform the design of future studies. PMID:27051131

Ten-year NEDO BVAD development program: moving forward to the clinical arena.

PubMed

Motomura, Tadashi; Okubo, Hisashi; Oda, Takeshi; Ogawa, Daisuke; Okahisa, Toshiya; Igo, Stephen; Shinohara, Toshiyuki; Yamamoto, Yoshiro; Noguchi, Chikaya; Ishizuka, Tsukasa; Okamoto, Eiji; Nosé, Yukihiko

2006-01-01

Since 1995, the Baylor Group has been developing a totally implantable NEDO BVAD system. This 10-year program was completed in March 2005, and preparation for clinical trials is underway. This article summarizes the entire 10-year NEDO program and describes the strategy for clinical trials. The project aimed to achieve: (1) dual centrifugal pumps with the ability of full biventricular support, (2) a compact system implantable into small adults, (3) a totally implantable system with transcutaneous energy transmission system (TETS), (4) a durable system with a lifetime of over 5 years, and (5) a system free of thrombus and with minimal hemolysis. The final goals are to complete preclinical system evaluations and commence the clinical trials in the near future. In vitro studies have demonstrated a pump capacity of over 8.5 l/min and an Index of Hemolysis of <0.004 g/100 l. The pump-bearing life expectancy was over 5 years. To date, eight pumps endured in vivo studies of over 3 months without complications, including thromboembolic events. The in vitro endurance studies of eight pumps are longer than 1 year. There were no mechanical malfunctions or pump failure. A stepwise clinical trial is being planned: Step1, a wearable BVAD/VAD will be clinically studied; Step 2, the BVAD/VAD will be implanted intracorporeally without TETS; and, Step 3, a totally implantable system will be clinically evaluated. The NEDO BVAD system has completed preclinical testing. Clinical trial preparation is underway.

Effectiveness of a Clinic-Based Early Literacy Program in Changing Parent-Child Early Literacy Habits.

PubMed

Fricke, Jonathan; Navsaria, Dipesh; Mahony, Karin

2016-12-01

Reach Out and Read (ROR) improves children's development and kindergarten readiness by encouraging parents to routinely share books with their children. Primary care providers give age-appropriate books and anticipatory guidance on reading at each well-child visit. This study evaluated parent attitudes and behaviors of early literacy related to ROR participation in Wisconsin clinics. A survey of early literacy attitudes and behaviors was administered to parents of children ages 6 months to 5 years in 36 Wisconsin clinics. Ten clinics were established ROR sites (intervention group) and 26 clinics had applied to become ROR programs but had not yet initiated the program (control group). Parents at clinics with ROR programs were more likely to read with a child under the age of 6 months (OR=1.58, 95% CI, 1.05-2.38). Other literacy metrics trended toward improvement but none reached statistical significance. Paradoxically, the odds of parents reporting reading as a bedtime habit were decreased among those who participated in ROR. Our study finds mixed support of the effectiveness of ROR outside of academic settings. The apparent discrepancy between these results and those from national studies on ROR may be related to differences in respondent demographics and educational attainment or differences in program implementation and fidelity. We believe that the results will become clearer with future study as clinics are prospectively evaluated over time rather than being compared to non-ROR clinics in a cross-sectional snapshot.

Organizational structure, team process, and future directions of interprofessional health care teams.

PubMed

Cole, Kenneth D; Waite, Martha S; Nichols, Linda O

2003-01-01

For a nationwide Geriatric Interdisciplinary Team Training (GITT) program evaluation of 8 sites and 26 teams, team evaluators developed a quantitative and qualitative team observation scale (TOS), examining structure, process, and outcome, with specific focus on the training function. Qualitative data provided an important expansion of quantitative data, highlighting positive effects that were not statistically significant, such as role modeling and training occurring within the clinical team. Qualitative data could also identify "too much" of a coded variable, such as time spent in individual team members' assessments and treatment plans. As healthcare organizations have increasing demands for productivity and changing reimbursement, traditional models of teamwork, with large teams and structured meetings, may no longer be as functional as they once were. To meet these constraints and to train students in teamwork, teams of the future will have to make choices, from developing and setting specific models to increasing the use of information technology to create virtual teams. Both quantitative and qualitative data will be needed to evaluate these new types of teams and the important outcomes they produce.

Longitudinal changes in white matter disease and cognition in the first year of the Alzheimer disease neuroimaging initiative.

PubMed

Carmichael, Owen; Schwarz, Christopher; Drucker, David; Fletcher, Evan; Harvey, Danielle; Beckett, Laurel; Jack, Clifford R; Weiner, Michael; DeCarli, Charles

2010-11-01

To evaluate relationships between magnetic resonance imaging (MRI)-based measures of white matter hyperintensities (WMHs), measured at baseline and longitudinally, and 1-year cognitive decline using a large convenience sample in a clinical trial design with a relatively mild profile of cardiovascular risk factors. Convenience sample in a clinical trial design. A total of 804 participants in the Alzheimer Disease Neuroimaging Initiative who received MRI scans, cognitive testing, and clinical evaluations at baseline, 6-month follow-up, and 12-month follow-up visits. For each scan, WMHs were detected automatically on coregistered sets of T1, proton density, and T2 MRI images using a validated method. Mixed-effects regression models evaluated relationships between risk factors for WMHs, WMH volume, and change in outcome measures including Mini-Mental State Examination (MMSE), Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and Clinical Dementia Rating Scale sum of boxes scores. Covariates in these models included race, sex, years of education, age, apolipoprotein E genotype, baseline clinical diagnosis (cognitively normal, mild cognitive impairment, or Alzheimer disease), cardiovascular risk score, and MRI-based hippocampal and brain volumes. Higher baseline WMH volume was associated with greater subsequent 1-year increase in ADAS-Cog and decrease in MMSE scores. Greater WMH volume at follow-up was associated with greater ADAS-Cog and lower MMSE scores at follow-up. Higher baseline age and cardiovascular risk score and more impaired baseline clinical diagnosis were associated with higher baseline WMH volume. White matter hyperintensity volume predicts 1-year cognitive decline in a relatively healthy convenience sample that was similar to clinical trial samples, and therefore should be considered as a covariate of interest at baseline and longitudinally in future AD treatment trials.

How Stable are Temperaments in the Clinical Setting: A Pilot Study

PubMed Central

Karam, Elie G.; El Khoury, Elaine; Itani, Lynn

2016-01-01

Background An essential point in evaluating the utility of measuring temperaments is the stability of the instrument used especially in the presence of mental disorders. One of the most commonly used instruments in the clinical setting is the Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire (TEMPS-A). To our knowledge, the TEMPS-A’s stability in an outpatient adult clinical setting has not been evaluated. Objective: To assess the stability of the effect of temperament, time and clinical intervention. Methods: A sample of 89 adult outpatients was assessed at baseline and follow-up on their TEMPS-A scores. Diagnoses of mental disorders were reached through clinical interviews, and the severity of the conditions was clinically assessed at baseline and follow-up on a Likert scale. Changes in scores were examined in terms of z-scores, and possible predictors of the change in scores were assessed. Results: Eighty-nine percent of all subjects’ temperaments scores did not change or changed less than one z-score, and specifically: 84.2% in the case of depressive, 89.9% for cyclothymic, 92.1% for hyperthymic, 92.2% for irritable, and 86.5% for anxious temperaments. For all of the five temperaments, age, gender, time difference between baseline and follow up, number of diagnoses, and percent improvement were not significantly associated with the change in temperament scores. Limitations: Well-established severity measures would add to the validity of any future findings. Conclusion: Shifts in temperament scores between baseline and follow-up were minor, thus proving the stability of temperaments and the TEMPS-A scale in a clinical setting. PMID:27733865

Bridging the Gap between Research and Clinical Practice in Asymptomatic Alzheimer's Disease.

PubMed

Downing, A M; Yaari, R; Ball, D E; Selzler, K J; Devous, M D

2016-01-01

Due to the growing global health impact of Alzheimer's disease (AD), there is a greater need for interventions that prevent or delay the onset of clinical symptoms of this debilitating disease. Clinical trials for disease-modifying compounds in AD have shifted towards earlier stages in the spectrum of illness, including the stage prior to cognitive symptoms. A population of specific interest for clinical research includes individuals with evidence of Alzheimer's disease pathology who are asymptomatic (ADPa). The challenges and barriers regarding medical treatment of ADPa must be identified and addressed prior to the completion of a positive clinical trial in order to accelerate the translation of research findings to clinical practice. This report applies an existing public health impact model from Spencer and colleagues (2013) to evaluate the readiness of the clinical practice environment to treat ADPa individuals if a disease-modifying agent achieves approval. We contrast the current clinical practice environment with a potential future state through investigating the effectiveness, reach, feasibility, sustainability, and transferability of the practice of treating ADPa individuals.

Evaluation of a primary care adult mental health service: Year 2

PubMed Central

2013-01-01

Aims This study aimed to examine the effectiveness of a primary care adult mental health service operating within a stepped care model of service delivery. Methods Supervised by a principal psychologist manager, psychology graduate practitioners provided one-to-one brief cognitive behavioural therapy (CBT) to service users. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) was used to assess service user treatment outcomes. Satisfaction questionnaires were administered to service users and referring general practitioners (GPs). Results A total of 43 individuals attended for an initial appointment, of whom 19 (44.2%) completed brief CBT treatment. Of the 13 service users who were in the clinical range pre-treatment, 11 (84.6%) achieved clinical and reliably significant improvement. Of the six service users who were in the non-clinical range pre-treatment, three (50%) achieved reliably significant improvement. Both service users and GPs indicated high levels of satisfaction with the service, although service accessibility was highlighted as needing improvement. Conclusion The service was effective in treating mild to moderate mental health problems in primary care. Stricter adherence to a stepped care model through the provision of low-intensity, high-throughput interventions would be desirable for future service provision. PMID:24381655

The PBRN Initiative

PubMed Central

Curro, F.A.; Vena, D.; Naftolin, F.; Terracio, L.; Thompson, V.P.

2012-01-01

The NIDCR-supported Practice-based Research Network initiative presents dentistry with an unprecedented opportunity by providing a pathway for modifying and advancing the profession. It encourages practitioner participation in the transfer of science into practice for the improvement of patient care. PBRNs vary in infrastructure and design, and sustaining themselves in the long term may involve clinical trial validation by regulatory agencies. This paper discusses the PBRN concept in general and uses the New York University College of Dentistry’s Practitioners Engaged in Applied Research and Learning (PEARL) Network as a model to improve patient outcomes. The PEARL Network is structured to ensure generalizability of results, data integrity, and to provide an infrastructure in which scientists can address clinical practitioner research interests. PEARL evaluates new technologies, conducts comparative effectiveness research, participates in multidisciplinary clinical studies, helps evaluate alternative models of healthcare, educates and trains future clinical faculty for academic positions, expands continuing education to include “benchmarking” as a form of continuous feedback to practitioners, adds value to dental schools’ educational programs, and collaborates with the oral health care and pharmaceutical industries and medical PBRNs to advance the dental profession and further the integration of dental research and practice into contemporary healthcare (NCT00867997, NCT01268605). PMID:22699662

Innovative regenerative medicines in the EU: a better future in evidence?

PubMed

Corbett, Mark S; Webster, Andrew; Hawkins, Robert; Woolacott, Nerys

2017-03-08

Despite a steady stream of headlines suggesting they will transform the future of healthcare, high-tech regenerative medicines have, to date, been quite inaccessible to patients, with only eight having been granted an EU marketing licence in the last 7 years. Here, we outline some of the historical reasons for this paucity of licensed innovative regenerative medicines. We discuss the challenges to be overcome to expedite the development of this complex and rapidly changing area of medicine, together with possible reasons to be more optimistic for the future. Several factors have contributed to the scarcity of cutting-edge regenerative medicines in clinical practice. These include the great expense and difficulties involved in planning how individual therapies will be developed, manufactured to commercial levels and ultimately successfully delivered to patients. Specific challenges also exist when evaluating the safety, efficacy and cost-effectiveness of these therapies. Furthermore, many treatments are used without a licence from the European Medicines Agency, under "Hospital Exemption" from the EC legislation. For products which are licensed, alternative financing approaches by healthcare providers may be needed, since many therapies will have significant up-front costs but uncertain benefits and harms in the long-term. However, increasing political interest and more flexible mechanisms for licensing and financing of therapies are now evident; these could be key to the future growth and development of regenerative medicine in clinical practice. Recent developments in regulatory processes, coupled with increasing political interest, may offer some hope for improvements to the long and often difficult routes from laboratory to marketplace for leading-edge cell or tissue therapies. Collaboration between publicly-funded researchers and the pharmaceutical industry could be key to the future development of regenerative medicine in clinical practice; such collaborations might also offer a possible antidote to the innovation crisis in the pharmaceutical industry.

Deriving Competencies for Mentors of Clinical and Translational Scholars

PubMed Central

Abedin, Zainab; Biskup, Ewelina; Silet, Karin; Garbutt, Jane M.; Kroenke, Kurt; Feldman, Mitchell D.; McGee, Jr, Richard; Fleming, Michael; Pincus, Harold Alan

2012-01-01

Abstract Although the importance of research mentorship has been well established, the role of mentors of junior clinical and translational science investigators is not clearly defined. The authors attempt to derive a list of actionable competencies for mentors from a series of complementary methods. We examined focus groups, the literature, competencies derived for clinical and translational scholars, mentor training curricula, mentor evaluation forms and finally conducted an expert panel process in order to compose this list. These efforts resulted in a set of competencies that include generic competencies expected of all mentors, competencies specific to scientists, and competencies that are clinical and translational research specific. They are divided into six thematic areas: (1) Communication and managing the relationship, (2) Psychosocial support, (3) Career and professional development, (4) Professional enculturation and scientific integrity, (5) Research development, and (6) Clinical and translational investigator development. For each thematic area, we have listed associated competencies, 19 in total. For each competency, we list examples that are actionable and measurable. Although a comprehensive approach was used to derive this list of competencies, further work will be required to parse out how to apply and adapt them, as well future research directions and evaluation processes. Clin Trans Sci 2012; Volume 5: 273–280 PMID:22686206

Probiotic and synbiotic safety in infants under two years of age.

PubMed

van den Nieuwboer, M; Claassen, E; Morelli, L; Guarner, F; Brummer, R J

2014-03-01

In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.

Development of a PCR Assay to Detect Low Level Trypanosoma cruzi in Blood Specimens Collected with PAXgene Blood DNA Tubes for Clinical Trials Treating Chagas Disease.

PubMed

Wei, Bo; Chen, Lei; Kibukawa, Miho; Kang, John; Waskin, Hetty; Marton, Matthew

2016-12-01

Chagas disease is caused by the parasitic infection of Trypanosoma cruzi (T. cruzi). The STOP CHAGAS clinical trial was initiated in 2011 to evaluate posaconazole in treating Chagas disease, with treatment success defined as negative qualitative PCR results of detecting the parasites in blood specimens collected post-treatment. PAXgene Blood DNA tubes were utilized as a simple procedure to collect and process blood specimens. However, the PAXgene blood specimens challenged published T. cruzi PCR methods, resulting in poor sensitivity and reproducibility. To accurately evaluate the treatment efficacy of the clinical study, we developed and validated a robust PCR assay for detecting low level T. cruzi in PAXgene blood specimens. The assay combines a new DNA extraction method with a custom designed qPCR assay, resulting in limit of detection of 0.005 and 0.01 fg/μl for K98 and CL Brener, two representative strains of two of T. cruzi's discrete typing units. Reliable qPCR standard curves were established for both strains to measure parasite loads, with amplification efficiency ≥ 90% and the lower limit of linearity ≥ 0.05 fg/μl. The assay successfully analyzed the samples collected from the STOP CHAGAS study and may prove useful for future global clinical trials evaluating new therapies for asymptomatic chronic Chagas disease.

Metastatic melanoma - a review of current and future drugs.

PubMed

Velho, Tiago Rodrigues

2012-11-19

Melanoma is one of the most aggressive cancers, and it is estimated that 76,250 men and women will be diagnosed with melanoma of the skin in the USA in 2012. Over the last few decades many drugs have been developed but only in 2011 have new drugs demonstrated an impact on survival in metastatic melanoma. A systematic search of literature was conducted, and studies providing data on the effectiveness of current and/or future drugs used in the treatment of metastatic melanoma were selected for review. This review discusses the advantages and limitations of these agents, evaluating past, current and future clinical trials designed to overcome such limitations. To date, there are four drugs approved by the Food and Drug Administration for melanoma (dacarbazine, interleukin-2, ipilimumab and vemurafenib). Despite efforts to develop new drugs, few of them have demonstrated any clinical benefits. Approved in 1975, dacarbazine remains the gold standard in chemotherapy, although ipilimumab and vemurafenib have raised many hopes in the last few years. Combining dacarbazine or other chemotherapy agents with new pharmacological agents may be a new way to achieve better clinical responses in patients with metastatic melanoma. Advances in the molecular knowledge of melanoma have led to major improvements in the treatment of patients with metastatic melanoma, providing new targets and insights. However, heterogeneity amongst study populations, different approaches to treatment and the different melanoma types and localisations included in the trials makes their comparison difficult. New studies focusing on drugs developed in recent decades are warranted.

Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients

PubMed Central

2012-01-01

Background Type 2 Diabetes Mellitus (DM) is a common chronic disease associated with multiple clinical complications. Management guidelines have been established which recommend a risk-stratified approach to managing these patients in primary care. This study aims to evaluate the quality of care (QOC) and effectiveness of a multi-disciplinary risk assessment and management programme (RAMP) for type 2 diabetic patients attending government-funded primary care clinics in Hong Kong. The evaluation will be conducted using a structured and comprehensive evidence-based evaluation framework. Method/design For evaluation of the quality of care, a longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the pre-set target standards for criteria related to the structure and process of care are achieved. Each participating clinic will be invited to complete a Structure of Care Questionnaire evaluating pre-defined indicators which reflect the setting in which care is delivered, while process of care will be evaluated against the pre-defined indicators in the evaluation framework. Effectiveness of the programme will be evaluated in terms of clinical outcomes, service utilization outcomes, and patient-reported outcomes. A cohort study will be conducted on all eligible diabetic patients who have enrolled into RAMP for more than one year to compare their clinical and public service utilization outcomes of RAMP participants and non-participants. Clinical outcome measures will include HbA1c, blood pressure (both systolic and diastolic), lipids (low-density lipoprotein cholesterol) and future cardiovascular diseases risk prediction; and public health service utilization rate will include general and specialist outpatient, emergency department attendances, and hospital admissions annually within 5 years. For patient-reported outcomes, a total of 550 participants and another 550 non-participants will be followed by telephone to monitor quality of life, patient enablement, global rating of change in health and private health service utilization at baseline, 6, 12, 36 and 60 months. Discussion The quality of care and effectiveness of the RAMP in enhancing the health for patients with type 2 diabetes will be determined. Possible areas for quality enhancement will be identified and standards of good practice can be established. The information will be useful in guiding service planning and policy decision making. PMID:23216708

Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients.

PubMed

Fung, Colman S C; Chin, Weng Yee; Dai, Daisy S K; Kwok, Ruby L P; Tsui, Eva L H; Wan, Yuk Fai; Wong, Wendy; Wong, Carlos K H; Fong, Daniel Y T; Lam, Cindy L K

2012-12-05

Type 2 Diabetes Mellitus (DM) is a common chronic disease associated with multiple clinical complications. Management guidelines have been established which recommend a risk-stratified approach to managing these patients in primary care. This study aims to evaluate the quality of care (QOC) and effectiveness of a multi-disciplinary risk assessment and management programme (RAMP) for type 2 diabetic patients attending government-funded primary care clinics in Hong Kong. The evaluation will be conducted using a structured and comprehensive evidence-based evaluation framework. For evaluation of the quality of care, a longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the pre-set target standards for criteria related to the structure and process of care are achieved. Each participating clinic will be invited to complete a Structure of Care Questionnaire evaluating pre-defined indicators which reflect the setting in which care is delivered, while process of care will be evaluated against the pre-defined indicators in the evaluation framework.Effectiveness of the programme will be evaluated in terms of clinical outcomes, service utilization outcomes, and patient-reported outcomes. A cohort study will be conducted on all eligible diabetic patients who have enrolled into RAMP for more than one year to compare their clinical and public service utilization outcomes of RAMP participants and non-participants. Clinical outcome measures will include HbA1c, blood pressure (both systolic and diastolic), lipids (low-density lipoprotein cholesterol) and future cardiovascular diseases risk prediction; and public health service utilization rate will include general and specialist outpatient, emergency department attendances, and hospital admissions annually within 5 years. For patient-reported outcomes, a total of 550 participants and another 550 non-participants will be followed by telephone to monitor quality of life, patient enablement, global rating of change in health and private health service utilization at baseline, 6, 12, 36 and 60 months. The quality of care and effectiveness of the RAMP in enhancing the health for patients with type 2 diabetes will be determined. Possible areas for quality enhancement will be identified and standards of good practice can be established. The information will be useful in guiding service planning and policy decision making.

Stakeholders' Perspectives on Preclinical Testing for Alzheimer's Disease.

PubMed

Arias, Jalayne J; Cummings, Jeffrey; Grant, Alexander Rae; Ford, Paul J

2015-01-01

Progress towards validating amyloid beta as an early indicator of Alzheimer's disease (AD) heightens the need for evaluation of stakeholders' perspectives of the benefits and harms of preclinical testing in asymptomatic individuals. Investigators conducted and analyzed 14 semi-structured interviews with family members of patients diagnosed with AD. Participants reported benefits, including the potential to seek treatment, make lifestyle changes, and prepare for cognitive impairment. Participants identified harms, including social harms, adverse life decisions, and psychological harms. Nine participants reported either a "positive global perspective" or a "positive global perspective (qualified)." Results from this study characterized stakeholders' perspectives on the potential benefits and harms of clinical use of preclinical testing for AD. Investigators used data from this study to develop a framework that contributes to ongoing discussions that will evaluate widespread adoption of preclinical testing and will inform future research. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

[Antibacterial and antifungal activity of Salvia apiana against clinically important microorganisms].

PubMed

Córdova-Guerrero, Iván; Aragon-Martinez, Othoniel H; Díaz-Rubio, Laura; Franco-Cabrera, Santiago; Serafín-Higuera, Nicolas A; Pozos-Guillén, Amaury; Soto-Castro, Tely A; Martinez-Morales, Flavio; Isiordia-Espinoza, Mario

Due to the great global concern regarding bacterial resistance to antibiotics, an ongoing search for new molecules having antibacterial activity is necessary. This study evaluated the antibacterial and anticandidal effects of a hexane extract from the root of Salvia apiana. Salvia extracts at concentrations of 27, 13.5, 6.8 and 3.4mg/ml caused growth inhibition of Staphylococcus aureus, Streptococcus pyogenes, Enterococcus faecalis and Candida albicans. However, no significant effect was observed on Escherichia coli and Candida tropicalis in comparison to vehicle. It was here demonstrated for the first time that Salvia apiana has an important antimicrobial effect on human pathogens of great clinical value, thus opening the field to continue the evaluation of this lamiaceous plant for its future use as a therapeutic agent. Copyright © 2016 Asociación Argentina de Microbiología. Publicado por Elsevier España, S.L.U. All rights reserved.

SHOULDER ARTHROPLASTY RECORDS

PubMed Central

Filho, Geraldo Motta; Galvão, Marcus Vinicius; Monteiro, Martim; Cohen, Marcio; Brandão, Bruno

2015-01-01

The study's objective is to evaluate the characteristics and problems of patients who underwent shoulder arthroplasties between July 2004 and November 2006. Methodology: During the period of the study, 145 shoulder arthroplasties were performed. A prospective protocol was used for every patient; demographic, clinical and surgical procedure data were collected. All gathered data were included in the data base. The patients were divided in three major groups: fractures, degenerative diseases and trauma sequels. Information obtained from the data base was correlated in order to determine patients' epidemiologic, injuries, and surgical procedure profiles. Results: Of the 145 shoulder arthroplasties performed, 37% presented trauma sequels, 30% degenerative diseases, and 33% proximal humerus fracture. 12% of the cases required total arthroplasties and 88% partial arthroplasties. Five major complications were observed on early postoperative period. Conclusion: Shoulder arthroplasties have become a common procedure in orthopaedic practice. Surgical records are important in evidencing progressive evolution and in enabling future clinical outcomes evaluation. PMID:26998463

Models for the study of Clostridium difficile infection

PubMed Central

Best, Emma L.; Freeman, Jane; Wilcox, Mark H.

2012-01-01

Models of Clostridium difficile infection (C. difficile) have been used extensively for Clostridium difficile (C. difficile) research. The hamster model of C. difficile infection has been most extensively employed for the study of C. difficile and this has been used in many different areas of research, including the induction of C. difficile, the testing of new treatments, population dynamics and characterization of virulence. Investigations using in vitro models for C. difficile introduced the concept of colonization resistance, evaluated the role of antibiotics in C. difficile development, explored population dynamics and have been useful in the evaluation of C. difficile treatments. Experiments using models have major advantages over clinical studies and have been indispensible in furthering C. difficile research. It is important for future study programs to carefully consider the approach to use and therefore be better placed to inform the design and interpretation of clinical studies. PMID:22555466

An Evaluation of Instructive Feedback to Teach Play Behavior to a Child with Autism Spectrum Disorder.

PubMed

Grow, Laura L; Kodak, Tiffany; Clements, Andrea

2017-09-01

Instructive feedback is used to expose learners to secondary targets during skill acquisition programs (Reichow & Wolery, in Journal of Applied Behavior Analysis, 44 , 327-340, 2011; Werts, Wolery, Gast, & Holcombe, in Journal of Behavioral Education, 5 , 55-75, 1995). Although unrelated feedback may have clinical utility in practice, very little research has evaluated unrelated instructive feedback, particularly for promoting play behavior (Colozzi, Ward, & Crotty, in Education and Training in Developmental Disabilities, 43 , 226-248, 2008). The purpose of the study was to determine if play emerged after embedding instructive feedback during the consequence portion of discrete trial training to teach tacts. An adapted alternating treatments design was used to compare tact training with and without instructive feedback for play behaviors. Instructive feedback resulted in the emergence of play behaviors during tabletop instruction and a play area of a classroom. We discuss the results in terms of clinical practice and future research.

Personal digital assistants herald new approaches to teaching and evaluation in medical education.

PubMed

Bertling, Chad J; Simpson, Deborah E; Hayes, Avery M; Torre, Dario; Brown, Diane L; Schubot, David B

2003-01-01

Since its arrival in 1994, the personal digital assistant (PDA) has made significant inroads in the handheld industry, with 50% of physicians anticipated as users by 2005 due to its functionality as a point-of-care medical informatics tool. However, its use in medical education is less well documented. Since 1998, PDAs have been used at Medical College of Wisconsin (MCW) as both a teaching and an evaluation tool for medical student and resident education. This article highlights the use of the PDA in medical education and describes current applications for monitoring clinical experiences of students/residents, and teaching resources for hypertension, cardiac auscultation, and community health. MCW's experiences with the PDA as a real time teaching and data collection tool serves as a model for other medical schools and for our students who are educated in the importance of self-monitoring one's clinical experiences and the need for continuous improvement as future physicians.

Research using qualitative, quantitative or mixed methods and choice based on the research.

PubMed

McCusker, K; Gunaydin, S

2015-10-01

Research is fundamental to the advancement of medicine and critical to identifying the most optimal therapies unique to particular societies. This is easily observed through the dynamics associated with pharmacology, surgical technique and the medical equipment used today versus short years ago. Advancements in knowledge synthesis and reporting guidelines enhance the quality, scope and applicability of results; thus, improving health science and clinical practice and advancing health policy. While advancements are critical to the progression of optimal health care, the high cost associated with these endeavors cannot be ignored. Research fundamentally needs to be evaluated to identify the most efficient methods of evaluation. The primary objective of this paper is to look at a specific research methodology when applied to the area of clinical research, especially extracorporeal circulation and its prognosis for the future. © The Author(s) 2014.

From the patient to the clinical mycology laboratory: how can we optimise microscopy and culture methods for mould identification?

PubMed

Vyzantiadis, Timoleon-Achilleas A; Johnson, Elizabeth M; Kibbler, Christopher C

2012-06-01

The identification of fungi relies mainly on morphological criteria. However, there is a need for robust and definitive phenotypic identification procedures in order to evaluate continuously evolving molecular methods. For the future, there is an emerging consensus that a combined (phenotypic and molecular) approach is more powerful for fungal identification, especially for moulds. Most of the procedures used for phenotypic identification are based on experience rather than comparative studies of effectiveness or performance and there is a need for standardisation among mycology laboratories. This review summarises and evaluates the evidence for the major existing phenotypic identification procedures for the predominant causes of opportunistic mould infection. We have concentrated mainly on Aspergillus, Fusarium and mucoraceous mould species, as these are the most important clinically and the ones for which there are the most molecular taxonomic data.

Survey on multisensory feedback virtual reality dental training systems.

PubMed

Wang, D; Li, T; Zhang, Y; Hou, J

2016-11-01

Compared with traditional dental training methods, virtual reality training systems integrated with multisensory feedback possess potentials advantages. However, there exist many technical challenges in developing a satisfactory simulator. In this manuscript, we systematically survey several current dental training systems to identify the gaps between the capabilities of these systems and the clinical training requirements. After briefly summarising the components, functions and unique features of each system, we discuss the technical challenges behind these systems including the software, hardware and user evaluation methods. Finally, the clinical requirements of an ideal dental training system are proposed. Future research/development areas are identified based on an analysis of the gaps between current systems and clinical training requirements. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Ongoing Use of Data and Specimens from NCI Sponsored Cancer Prevention Clinical Trials in the Community Clinical Oncology Program

PubMed Central

Minasian, Lori; Tangen, Catherine M.; Wickerham, D. Lawrence

2015-01-01

Large cancer prevention trials provide opportunities to collect a wide array of data and biospecimens at study entry and longitudinally, for a healthy, aging population without cancer. This provides an opportunity to use pre-diagnostic data and specimens to evaluate hypotheses about the initial development of cancer. This paper reports on strides made by, and future possibilities for, the use of accessible biorepositories developed from precisely annotated samples obtained through large-scale National Cancer Institute (NCI)-sponsored cancer prevention clinical trials conducted by the NCI Cooperative Groups. These large cancer prevention studies, which have enrolled over 80,000 volunteers, continue to contribute to our understanding of cancer development more than 10 years after they were closed. PMID:26433556

Reliability, validity, and utility of the Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) in assessments of bariatric surgery candidates.

PubMed

Tarescavage, Anthony M; Wygant, Dustin B; Boutacoff, Lana I; Ben-Porath, Yossef S

2013-12-01

In the current study, we examined the reliability, validity, and clinical utility of Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF; Ben-Porath & Tellegen, 2011) scores in a sample of 759 bariatric surgery candidates. We provide descriptives for all scales, internal consistency and standard error of measurement estimates for all substantive scales, external correlates of substantive scales using chart review and self-report criteria, and relative risk ratios to assess the clinical utility of the instrument. Results generally support the reliability, validity, and clinical utility of MMPI-2-RF scale scores in the psychological evaluation of bariatric surgery candidates. Limitations, future directions, and practical application of these results are discussed. (c) 2013 APA, all rights reserved.

Future directions in treatment of brain metastases

PubMed Central

Barani, Igor J.; Larson, David A.; Berger, Mitchel S.

2013-01-01

Background: Brain metastases affect up to 30% of patients with cancer. Management of brain metastases continues to evolve with ever increasing focus on cognitive preservation and quality of life. This manuscript reviews current state of brain metastases management and discusses various treatment controversies with focus on future clinical trials. Stereotactic radiosurgery (SRS) and whole-brain radiotherapy (WBRT) are discussed in context of multiple (4+ brain metastases) as well as new approaches combining radiation and targeted agents. A brief discussion of modified WBRT approaches, including hippocampal-avoidance WBRT (HA-WBRT) is included as well as a section on recently presented results of Radiation Therapy Oncology Group (RTOG) 0614, a randomized, double-blind, placebo-controlled trial of menantine for prevention of neurocognitive injury after WBRT. Methods: A search of selected studies relevant to management of brain metastases was performed in PubMed as well as in various published meeting abstracts. This data was collated and analyzed in context of contemporary management and future clinical trial plans. This data is presented in tabular form and discussed extensively in the text. Results: The published data demonstrate continued evolution of clinical trials and management strategies designed to minimize and/or prevent cognitive decline following radiation therapy management of brain metastases. Hippocampal avoidance whole-brain radiation therapy (HA-WBRT) and radiosurgery treatments for multiple brain metastases are discussed along with preliminary results of RTOG 0614, a trial of memantine therapy to prevent cognitive decline following WBRT. Trial results appear to support the use of memantine for prevention of cognitive decline. Conclusions: Different management strategies for multiple brain metastases (>4 brain metastases) are currently being evaluated in prospective clinical trials to minimize the likelihood of cognitive decline following WBRT. PMID:23717793

Future directions in treatment of brain metastases.

PubMed

Barani, Igor J; Larson, David A; Berger, Mitchel S

2013-01-01

Brain metastases affect up to 30% of patients with cancer. Management of brain metastases continues to evolve with ever increasing focus on cognitive preservation and quality of life. This manuscript reviews current state of brain metastases management and discusses various treatment controversies with focus on future clinical trials. Stereotactic radiosurgery (SRS) and whole-brain radiotherapy (WBRT) are discussed in context of multiple (4+ brain metastases) as well as new approaches combining radiation and targeted agents. A brief discussion of modified WBRT approaches, including hippocampal-avoidance WBRT (HA-WBRT) is included as well as a section on recently presented results of Radiation Therapy Oncology Group (RTOG) 0614, a randomized, double-blind, placebo-controlled trial of menantine for prevention of neurocognitive injury after WBRT. A search of selected studies relevant to management of brain metastases was performed in PubMed as well as in various published meeting abstracts. This data was collated and analyzed in context of contemporary management and future clinical trial plans. This data is presented in tabular form and discussed extensively in the text. The published data demonstrate continued evolution of clinical trials and management strategies designed to minimize and/or prevent cognitive decline following radiation therapy management of brain metastases. Hippocampal avoidance whole-brain radiation therapy (HA-WBRT) and radiosurgery treatments for multiple brain metastases are discussed along with preliminary results of RTOG 0614, a trial of memantine therapy to prevent cognitive decline following WBRT. Trial results appear to support the use of memantine for prevention of cognitive decline. Different management strategies for multiple brain metastases (>4 brain metastases) are currently being evaluated in prospective clinical trials to minimize the likelihood of cognitive decline following WBRT.

Usability Evaluation of Electronic Health Record System around Clinical Notes Usage-An Ethnographic Study.

PubMed

Rizvi, Rubina F; Marquard, Jenna L; Hultman, Gretchen M; Adam, Terrence J; Harder, Kathleen A; Melton, Genevieve B

2017-10-01

Background A substantial gap exists between current Electronic Health Record (EHR) usability and potential optimal usability. One of the fundamental reasons for this discrepancy is poor incorporation of a User-Centered Design (UCD) approach during the Graphical User Interface (GUI) development process. Objective To evaluate usability strengths and weaknesses of two widely implemented EHR GUIs for critical clinical notes usage tasks. Methods Twelve Internal Medicine resident physicians interacting with one of the two EHR systems (System-1 at Location-A and System-2 at Location-B) were observed by two usability evaluators employing an ethnographic approach. User comments and observer findings were analyzed for two critical tasks: (1) clinical notes entry and (2) related information-seeking tasks. Data were analyzed from two standpoints: (1) usability references categorized by usability evaluators as positive, negative, or equivocal and (2) usability impact of each feature measured through a 7-point severity rating scale. Findings were also validated by user responses to a post observation questionnaire. Results For clinical notes entry, System-1 surpassed System-2 with more positive (26% vs. 12%) than negative (12% vs. 34%) usability references. Greatest impact features on EHR usability (severity score pertaining to each feature) for clinical notes entry were: autopopulation (6), screen options (5.5), communication (5), copy pasting (4.5), error prevention (4.5), edit ability (4), and dictation and transcription (3.5). Both systems performed equally well on information-seeking tasks and features with greatest impacts on EHR usability were navigation for notes (7) and others (e.g., looking for ancillary data; 5.5). Ethnographic observations were supported by follow-up questionnaire responses. Conclusion This study provides usability-specific insights to inform future, improved, EHR interface that is better aligned with UCD approach.

Associations Between Traumatic Brain Injury History and Future Headache Severity in Veterans: A Longitudinal Study.

PubMed

Suri, Pradeep; Stolzmann, Kelly; Iverson, Katherine M; Williams, Rhonda; Meterko, Mark; Yan, Kun; Gormley, Katelyn; Pogoda, Terri K

2017-11-01

To determine whether traumatic brain injury (TBI) history is associated with worse headache severity outcomes. Prospective cohort study. Department of Veterans Affairs (VA) outpatient clinics. Veterans (N=2566) who completed a mail follow-up survey an average of 3 years after a comprehensive TBI evaluation (CTBIE). Not applicable. The presence or absence of TBI, and TBI severity were evaluated by a trained clinician and classified according to VA/Department of Defense clinical practice guidelines. Headache severity was evaluated at both the baseline CTBIE assessment and 3-year follow-up using a 5-level headache score ranging from 0 ("none") to 4 ("very severe") based on headache-associated activity interference in the past 30 days. We examined associations of mild and moderate/severe TBI history, as compared to no TBI history, with headache severity in cross-sectional and longitudinal analyses, with and without adjustment for potential confounders. Mean headache severity scores were 2.4 at baseline and 2.3 at 3-year follow-up. Mild TBI was associated with greater headache severity in multivariate-adjusted cross-sectional analyses (β [SE]=.61 [.07], P<.001), as compared with no TBI, but not in longitudinal analyses (β [SE]=.09 [.07], P=.20). Moderate/severe TBI was significantly associated with greater headache severity in both cross-sectional (β [SE]=.66 [.09], P<.001) and longitudinal analyses (β [SE]=.18 [.09], P=.04). Headache outcomes are poor in veterans who receive VA TBI evaluations, irrespective of past TBI exposure, but significantly worse in those with a history of moderate/severe TBI. No association was found between mild TBI and future headache severity in veterans. Veterans with headache presenting for TBI evaluations, and particularly those with moderate/severe TBI, may benefit from further evaluation and treatment of headache. Published by Elsevier Inc.

Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

PubMed

Logvinov, Ilana

2014-03-01

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical development of Ebola vaccines

PubMed Central

Sridhar, Saranya

2015-01-01

The ongoing outbreak of Ebola virus disease in West Africa highlighted the lack of a licensed drug or vaccine to combat the disease and has renewed the urgency to develop a pipeline of Ebola vaccines. A number of different vaccine platforms are being developed by assessing preclinical efficacy in animal models and expediting clinical development. Over 15 different vaccines are in preclinical development and 8 vaccines are now in different stages of clinical evaluation. These vaccines include DNA vaccines, virus-like particles and viral vectors such as live replicating vesicular stomatitis virus (rVSV), human and chimpanzee adenovirus, and vaccinia virus. Recently, in preliminary results reported from the first phase III trial of an Ebola vaccine, the rVSV-vectored vaccine showed promising efficacy. This review charts this rapidly advancing area of research focusing on vaccines in clinical development and discusses the future opportunities and challenges faced in the licensure and deployment of Ebola vaccines. PMID:26668751

Narrative thematic analysis of baccalaureate nursing students' reflections: critical thinking in the clinical education context.

PubMed

Naber, Jessica L; Hall, Joanne; Schadler, Craig Matthew

2014-09-01

This study sought to identify characteristics of clinically situated critical thinking in nursing students' reflections, originally part of a study guided by Richard Paul's model of critical thinking. Nurses are expected to apply critical thinking in all practice situations to improve health outcomes, including patient safety and satisfaction. In a previous study, Paul's model of critical thinking was used to develop questions for reflective writing assignments. Within that study, 30 nursing students completed six open-ended narratives of nurse-patient clinical encounters during an 8-week period. Improvements were seen in critical thinking scores after the intervention. This article reports the qualitative analysis of the content of six open-ended narratives. Six overarching themes were identified and combined into a tentative conceptual model. Faculty's understanding of the characteristics of critical thinking in the context of clinical education will help them to teach and evaluate students' progress and competencies for future practice.

European Vaccine Initiative: lessons from developing malaria vaccines.

PubMed

Geels, Mark J; Imoukhuede, Egeruan B; Imbault, Nathalie; van Schooten, Harry; McWade, Terry; Troye-Blomberg, Marita; Dobbelaer, Roland; Craig, Alister G; Leroy, Odile

2011-12-01

For over 10 years, the European Vaccine Initiative (EVI; European Malaria Vaccine Initiative until 2009) has contributed to the development of 24 malaria candidate vaccine antigens with 13 vaccine candidates being advanced into Phase I clinical trials, two of which have been transitioned for further clinical development in sub-Saharan Africa. Since its inception the EVI organization has operated as a funding agency, but with a clear service-oriented strategy. The scientific successes and difficulties encountered during these years and how these efforts have led to standardization and harmonization in vaccine development through large-scale European consortia are discussed. In the future, the EVI will remain instrumental in the pharmaceutical and clinical development of vaccines against 'diseases of poverty' with a continued focus on malaria. EVI will continue to focus on funding and managing preclinical evaluation up to Phase I/II clinical trials and strengthening the vaccine-development infrastructure in Europe, albeit with a global orientation.

Evidence-Based Parenting Interventions to Promote Secure Attachment

PubMed Central

Wright, Barry; Edginton, Elizabeth

2016-01-01

Various interventions are used in clinical practice to address insecure or disorganized attachment patterns and attachment disorders. The most common of these are parenting interventions, but not all have a robust empirical evidence base. We undertook a systematic review of randomized trials comparing a parenting intervention with a control, where these used a validated attachment instrument, in order to evaluate the clinical and cost-effectiveness of interventions aiming to improve attachment in children with severe attachment problems (mean age <13 years). This article aims to inform clinicians about the parenting interventions included in our systematic review that were clinically effective in promoting secure attachment. For completeness, we also briefly discuss other interventions without randomized controlled trial evidence, identified in Patient Public Involvement workshops and expert groups at the point our review was completed as being used or recommended. We outline the key implications of our findings for clinical practice and future research. PMID:27583298

The subcutaneous implantable cardioverter-defibrillator.

PubMed

Grace, Andrew

2014-01-01

To consider the case of need that underpinned the development of the subcutaneous implantable cardioverter-defibrillator (SICD), the preclinical and clinical data obtained so far, its current role and likely future. The data from prospective clinical evaluation of the device demonstrated safety and efficacy leading to Food and Drug Administration approval. This superseded earlier reports from Europe that raised some clinical concerns, previously anticipated through the introduction of new technology. Recent estimates indicate maybe 55% of patients in routine clinical practice needing an ICD are potentially suitable for a subcutaneous device. The SICD provides a useful alternative for high-energy (ICD) therapy in those deemed at risk and who need defibrillation and in whom there are no indications for cardiac resynchronization, bradycardia support or antitachycardia pacing. There is the possibility of both higher specificity and the avoidance of myo-cellular damage with shock delivery, and if these two aspects play out subcutaneous defibrillation could become an option of choice in many settings.

Clinical Trials Methods for Evaluation of Potential Reduced Exposure Products

PubMed Central

Hatsukami, Dorothy K.; Hanson, Karen; Briggs, Anna; Parascandola, Mark; Genkinger, Jeanine M.; O'Connor, Richard; Shields, Peter

2009-01-01

Potential reduced exposure tobacco products (PREPs) may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Assessment involves determining the effects of these products on biomarkers of exposure and of effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article raises the critical methodological issues associated with PREP assessment, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations for clinical trials PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop are provided. PMID:19959672

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

PubMed Central

Buch, Maya H; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

2015-01-01

Objectives Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. Methods We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A ‘0–10’ agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Results Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. Conclusions This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes. PMID:24827533

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer.

PubMed

Vargas, Roberto B; Ryan, Gery W; Jackson, Catherine A; Rodriguez, Rian; Freeman, Harold P

2008-07-15

Patient navigation is an intervention developed to reduce disparities in cancer care that is being widely replicated and receiving considerable support for demonstration projects and research to test its effectiveness. In the current study, the authors present an in-depth descriptive analysis of the original patient navigation programs to inform current and future program development. A qualitative multistakeholder case study using interviews and site visits of the first patient navigation site and 2 sites subsequently developed by the leadership of the original site were evaluated. At these sites, patient navigation is a system, as opposed to a person, comprised primarily of navigators and directors that work together to remove barriers and facilitate access in a well-defined course of care; navigators were from the community or were culturally similar to the patient population served but were also paid employees of the clinical care site with detailed knowledge of the clinical course patients must traverse to complete care plans. Directors had administrative authority over the clinical facility and social capital across institutions, and communicated regularly and openly with navigators to implement system level changes to remove barriers to care. Contextual factors such as policies supporting breast cancer care also influenced the implementation of these programs. The first patient navigation programs combined community and culturally sensitive care-coordination with aspects of disease management programs to reduce racial, ethnic, and poverty-driven disparities in care. Future efforts to replicate and evaluate patient navigation should take into account these unique aspects of the original patient navigation programs. (c) 2008 American Cancer Society.

Resident Evaluation of a Required Telepsychiatry Clinical Experience.

PubMed

Teshima, John; Hodgins, Michael; Boydell, Katherine M; Pignatiello, Antonio

2016-04-01

The authors explored resident experiences of telepsychiatry clinical training. This paper describes an analysis of evaluation forms completed by psychiatry residents following a required training experience in telepsychiatry. Retrospective numeric and narrative data were collected from 2005 to 2012. Using a five-point Likert-type scale (1 = strongly disagree and 5 = strongly agree), residents ranked the session based on the following characteristics: the overall experience, interest in participating in telepsychiatry in the future, understanding service provision to underserved areas, telepsychiatry as mode of service delivery, and the unique aspects of telepsychiatry work. The authors also conducted a content analysis of narrative comments in response to open-ended questions about the positive and negative aspects of the training experience. In all, 88% of residents completed (n = 335) an anonymous evaluation following their participation in telepsychiatry consultation sessions. Numeric results were mostly positive and indicated that the experience was interesting and enjoyable, enhanced interest in participating in telepsychiatry in the future, and increased understanding of providing psychiatric services to underserved communities. Narrative data demonstrated that the most valuable aspects of training included the knowledge acquired in terms of establishing rapport and engaging with patients, using the technology, working collaboratively, identifying different approaches used, and awareness of the complexity of cases. Resident desire for more training of this nature was prevalent, specifically a wish for more detail, additional time for discussion and debriefing, and further explanation of the unique aspects of telepsychiatry as mode of delivery. More evaluation of telepsychiatry training, elective or required, is needed. The context of this training offered potential side benefits of learning about interprofessional and collaborative care for the underserved.

iss050e042164

NASA Image and Video Library

2017-02-13

iss050e042164 (02/13/2017) --- NASA astronaut Peggy Whitson (right) and ESA (European Space Agency) astronaut Thomas Pesquet setup the Microgravity Science Glovebox (MSG) for the Microgravity Expanded Stem Cells (MESC) experiment. MESC cultivates human stem cells aboard the International Space Station for use in clinical trials to evaluate their use in treating disease. Results also advance future studies on how to scale up expansion of stem cells for treating stroke and other conditions.

The therapeutic potential of plant-derived vaccines and antibodies.

PubMed

Rodgers, P B; Hamilton, W D; Adair, J R

1999-03-01

The production of recombinant proteins in plants is reviewed with a particular focus on plant-derived vaccines and antibodies for human healthcare. Issues relating to foreign gene expression, such as protein yield, localisation and glycosylation are also considered. Emphasis is placed on reporting progress with preclinical and clinical evaluation of plant-derived vaccines and antibodies. An assessment is made of the likely future direction of research and development in this area.

Designing Clinical Trials of Interventions for Mobility Disability: Results from the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) Trial

PubMed Central

Espeland, Mark A.; Gill, Thomas M.; Guralnik, Jack; Miller, Michael E.; Fielding, Roger; Newman, Anne B.; Pahor, Marco

2008-01-01

Background Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. Methods Results are described from a pilot clinical trial in which 424 volunteers aged 70–89 years were randomly assigned to one of two interventions -- physical activity or a healthy aging education program -- and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in ≤10 seconds, a physical performance battery, and a questionnaire focused on physical function. Results Changes in all four outcomes were inter-related over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e. appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A four-year trial based on the outcome of 400 meter walk is projected to require N = 962 to 2,234 to detect an intervention effect of 30% to 20% with 90% power. Conclusions Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400 meter walk as their primary outcome. PMID:18000143

Update on the management of ulcerative colitis.

PubMed

Taba Taba Vakili, Sahar; Taher, Mohammad; Ebrahimi Daryani, Nasser

2012-01-01

The present treatment goals for inflammatory bowel diseases (IBD) especially ulcerative colitis (UC) include rapid induction of clinical remission, steroid-free maintenance of clinical remission, mucosal healing and improvement of quality of life in UC patients. Immunomodulators have been reserved for steroid- dependent or steroid- refractory UC patients. Among these agents, azathioprine/6-mercaptopurine should be used for maintenance of remission in quiescent UC. Calcineurin inhibitors can be prescribed as a short-term rescue therapy in steroid- refractory UC patients, but the long term efficacy of these agents remains unclear. According to retrospective studies, methotraxate is not recommended for inducing and maintaining remission in UC. Novel biological therapies targeting different specific immunological pathways continue to be developed and introduced for a variety of clinical scenarios in IBD. Infliximab is currently used for induction and maintenance therapy in patients who have moderately to severely active UC with an inadequate response to conventional agents such as aminosalicylates, corticosteroids, or immunomodulators. Other anti-TNF agents and biologic therapies are undergoing evaluation in clinical trials for their efficacy in IBD. Most patients who start biologics should continue treatment for the foreseeable future and potential consequences of discontinuation should be discussed with individual patients. Currently, data do not exist to administer biologics as first-line therapy in UC. Emerging data suggest that biologics may have the potential to prevent complications and limit disease progression. If such benefits are proven, biologics may be used in the future to modulate subclinical inflammation and to prevent the development of clinical disease.

Artificial neural networks in gynaecological diseases: current and potential future applications.

PubMed

Siristatidis, Charalampos S; Chrelias, Charalampos; Pouliakis, Abraham; Katsimanis, Evangelos; Kassanos, Dimitrios

2010-10-01

Current (and probably future) practice of medicine is mostly associated with prediction and accurate diagnosis. Especially in clinical practice, there is an increasing interest in constructing and using valid models of diagnosis and prediction. Artificial neural networks (ANNs) are mathematical systems being used as a prospective tool for reliable, flexible and quick assessment. They demonstrate high power in evaluating multifactorial data, assimilating information from multiple sources and detecting subtle and complex patterns. Their capability and difference from other statistical techniques lies in performing nonlinear statistical modelling. They represent a new alternative to logistic regression, which is the most commonly used method for developing predictive models for outcomes resulting from partitioning in medicine. In combination with the other non-algorithmic artificial intelligence techniques, they provide useful software engineering tools for the development of systems in quantitative medicine. Our paper first presents a brief introduction to ANNs, then, using what we consider the best available evidence through paradigms, we evaluate the ability of these networks to serve as first-line detection and prediction techniques in some of the most crucial fields in gynaecology. Finally, through the analysis of their current application, we explore their dynamics for future use.

The use of functional neuroimaging to evaluate psychological and other non-pharmacological treatments for clinical pain

PubMed Central

Jensen, Karin B.; Berna, Chantal; Loggia, Marco L.; Wasan, Ajay; Edwards, Robert R.; Gollub, Randy L.

2013-01-01

A large number of studies have provided evidence for the efficacy of psychological and other non-pharmacological interventions in the treatment of chronic pain. While these methods are increasingly used to treat pain, remarkably few studies focused on the exploration of their neural correlates. The aim of this article was to review the findings from neuroimaging studies that evaluated the neural response to distraction-based techniques, cognitive behavioral therapy (CBT), clinical hypnosis, mental imagery, physical therapy/exercise, biofeedback, and mirror therapy. To date, the results from studies that used neuroimaging to evaluate these methods have not been conclusive and the experimental methods have been suboptimal for assessing clinical pain. Still, several different psychological and non-pharmacological treatment modalities were associated with increased painrelated activations of executive cognitive brain regions, such as the ventral- and dorsolateral prefrontal cortex. There was also evidence for decreased pain-related activations in afferent pain regions and limbic structures. If future studies will address the technical and methodological challenges of today’s experiments, neuroimaging might have the potential of segregating the neural mechanisms of different treatment interventions and elucidate predictive and mediating factors for successful treatment outcomes. Evaluations of treatment-related brain changes (functional and structural) might also allow for sub-grouping of patients and help to develop individualized treatments. PMID:22445888

[How to assess mindfulness? Problems and future].

PubMed

Trousselard, M; Steiler, D; Claverie, D; Canini, F

2016-02-01

The concept of mindfulness is characterized by awareness and acceptance of experiences; flexible regulation of attention; an objective receptivity to experience and an orientation to the here-and-now. Interest in 'mindfulness' and 'mindfulness meditation' is recent and growing both at the levels of research and of clinical practice in the West as mindfulness is associated with health and well-being. It (mindfulness) is attained by the practice of certain types of meditation. One of the current key challenges is to evaluate and measure the level of mindfulness of a subject and its evolution. The paper proposes a reflexion on the concept of mindfulness with a view to improving the operational evaluation of mindfulness level for clinical and non-clinical subjects. First, the problems with the use of existing self-report questionnaires assessing mindfulness level are discussed. Second, an analysis of the cognitive processes that come into play in mindfulness acquisition (by meditation) can highlight the significance of certain cognitive tools in a more accurate evaluation of the level of mindfulness of individuals. Self-regulation of attention, and orientation to lived experience could be operational candidates for assessing the level of mindfulness. The pertinence of well-known paradigms evaluating self-regulation of attention and orientation to experience are discussed. Copyright © 2015 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

A human factors systems approach to understanding team-based primary care: a qualitative analysis

PubMed Central

Mundt, Marlon P.; Swedlund, Matthew P.

2016-01-01

Background. Research shows that high-functioning teams improve patient outcomes in primary care. However, there is no consensus on a conceptual model of team-based primary care that can be used to guide measurement and performance evaluation of teams. Objective. To qualitatively understand whether the Systems Engineering Initiative for Patient Safety (SEIPS) model could serve as a framework for creating and evaluating team-based primary care. Methods. We evaluated qualitative interview data from 19 clinicians and staff members from 6 primary care clinics associated with a large Midwestern university. All health care clinicians and staff in the study clinics completed a survey of their communication connections to team members. Social network analysis identified key informants for interviews by selecting the respondents with the highest frequency of communication ties as reported by their teammates. Semi-structured interviews focused on communication patterns, team climate and teamwork. Results. Themes derived from the interviews lent support to the SEIPS model components, such as the work system (Team, Tools and Technology, Physical Environment, Tasks and Organization), team processes and team outcomes. Conclusions. Our qualitative data support the SEIPS model as a promising conceptual framework for creating and evaluating primary care teams. Future studies of team-based care may benefit from using the SEIPS model to shift clinical practice to high functioning team-based primary care. PMID:27578837

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools

PubMed Central

2012-01-01

Background Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. Methods The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Results Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. Conclusions This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high “rule in” ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs. PMID:22646313

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools.

PubMed

Pressler, Taylor R; Yen, Po-Yin; Ding, Jing; Liu, Jianhua; Embi, Peter J; Payne, Philip R O

2012-05-30

Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high "rule in" ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs.

Steroid Sulfatase Inhibition by Aryl Sulfamates: Clinical Progress, Mechanism and Future Prospects.

PubMed

Potter, Barry V L

2018-04-04

Steroid sulfatase is an emerging drug target for the endocrine therapy of hormone-dependent diseases, catalyzing estrogen sulfate hydrolysis to estrogen. Drug discovery, developing the core aryl O-sulfamate pharmacophore, has led to steroidal and non-steroidal drugs entering numerous clinical trials, with promising results in oncology and women's health. Steroidal estrogen sulfamate derivatives were the first irreversible active-site-directed inhibitors and one was developed clinically as an oral estradiol pro-drug and for endometriosis applications. This review summarizes work leading to the therapeutic concept of sulfatase inhibition, clinical trials executed to date and new insights into the mechanism of inhibition of steroid sulfatase. To date the non-steroidal sulfatase inhibitor Irosustat has been evaluated clinically in breast cancer, alone and in combination, in endometrial cancer and in prostate cancer. The versatile core pharmacophore both imbues attractive pharmaceutical properties and functions via three distinct mechanisms of action, as a pro-drug, an enzyme active site-modifying motif, likely through direct sulfamoyl group transfer, and as a structural component augmenting activity, for example by enhancing interactions at the colchicine binding site of tubulin. Preliminary new structural data on the Pseudomonas aeruginosa arylsulfatase enzyme suggest two possible sulfamate-based adducts with active site hydrated formylglycine as candidates for the inhibition end product via sulfamoyl group transfer, and a speculative choice is suggested. The clinical status of sulfatase inhibition is surveyed and how it might develop in the future. Also discussed are dual-targeting approaches, development of 2-substituted steroidal sulfamates and nonsteroidal derivatives as multi-targeting agents for hormone-independent tumours with other emerging directions.

A Preliminary Study of Clinical Abbreviation Disambiguation in Real Time.

PubMed

Wu, Y; Denny, J C; Rosenbloom, S T; Miller, R A; Giuse, D A; Song, M; Xu, H

2015-01-01

To save time, healthcare providers frequently use abbreviations while authoring clinical documents. Nevertheless, abbreviations that authors deem unambiguous often confuse other readers, including clinicians, patients, and natural language processing (NLP) systems. Most current clinical NLP systems "post-process" notes long after clinicians enter them into electronic health record systems (EHRs). Such post-processing cannot guarantee 100% accuracy in abbreviation identification and disambiguation, since multiple alternative interpretations exist. Authors describe a prototype system for real-time Clinical Abbreviation Recognition and Disambiguation (rCARD) - i.e., a system that interacts with authors during note generation to verify correct abbreviation senses. The rCARD system design anticipates future integration with web-based clinical documentation systems to improve quality of healthcare records. When clinicians enter documents, rCARD will automatically recognize each abbreviation. For abbreviations with multiple possible senses, rCARD will show a ranked list of possible meanings with the best predicted sense at the top. The prototype application embodies three word sense disambiguation (WSD) methods to predict the correct senses of abbreviations. We then conducted three experments to evaluate rCARD, including 1) a performance evaluation of different WSD methods; 2) a time evaluation of real-time WSD methods; and 3) a user study of typing clinical sentences with abbreviations using rCARD. Using 4,721 sentences containing 25 commonly observed, highly ambiguous clinical abbreviations, our evaluation showed that the best profile-based method implemented in rCARD achieved a reasonable WSD accuracy of 88.8% (comparable to SVM - 89.5%) and the cost of time for the different WSD methods are also acceptable (ranging from 0.630 to 1.649 milliseconds within the same network). The preliminary user study also showed that the extra time costs by rCARD were about 5% of total document entry time and users did not feel a significant delay when using rCARD for clinical document entry. The study indicates that it is feasible to integrate a real-time, NLP-enabled abbreviation recognition and disambiguation module with clinical documentation systems.

Queerin' the PGD clinic : human enhancement and the future of bodily diversity.

PubMed

Sparrow, Robert

2013-06-01

Disability activists influenced by queer theory and advocates of "human enhancement" have each disputed the idea that what is "normal" is normatively significant, which currently plays a key role in the regulation of pre-implantation genetic diagnosis (PGD). Previously, I have argued that the only way to avoid the implication that parents have strong reasons to select children of one sex (most plausibly, female) over the other is to affirm the moral significance of sexually dimorphic human biological norms. After outlining the logic that generates this conclusion, I investigate the extent to which it might also facilitate an alternative, progressive, opening up of the notion of the normal and of the criteria against which we should evaluate the relative merits of different forms of embodiment. This paper therefore investigates the implications of ideas derived from queer theory for the future of PGD and of PGD for the future of queerness.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

PubMed

Jermendy, György

2018-04-01

Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

Advanced morphological and biochemical magnetic resonance imaging of cartilage repair procedures in the knee joint at 3 Tesla.

PubMed

Welsch, Goetz H; Mamisch, Tallal C; Hughes, Timothy; Domayer, Stephan; Marlovits, Stefan; Trattnig, Siegfried

2008-09-01

Morphological and biochemical magnetic resonance imaging (MRI) is due to high field MR systems, advanced coil technology, and sophisticated sequence protocols capable of visualizing articular cartilage in vivo with high resolution in clinical applicable scan time. Several conventional two-dimensional (2D) and three-dimensional (3D) approaches show changes in cartilage structure. Furthermore newer isotropic 3D sequences show great promise in improving cartilage imaging and additionally in diagnosing surrounding pathologies within the knee joint. Functional MR approaches are additionally able to provide a specific measure of the composition of cartilage. Cartilage physiology and ultra-structure can be determined, changes in cartilage macromolecules can be detected, and cartilage repair tissue can thus be assessed and potentially differentiated. In cartilage defects and following nonsurgical and surgical cartilage repair, morphological MRI provides the basis for diagnosis and follow-up evaluation, whereas biochemical MRI provides a deeper insight into the composition of cartilage and cartilage repair tissue. A combination of both, together with clinical evaluation, may represent a desirable multimodal approach in the future, also available in routine clinical use.

Evaluation of a microwave method for dry matter determination in faecal samples from weaned pigs with or without clinical diarrhoea.

PubMed

Pedersen, Ken Steen; Stege, Helle; Nielsen, Jens Peter

2011-07-01

Microwave drying as a procedure for determination of faecal dry matter in weaned pigs was evaluated and clinical relevant cut-off values between faecal consistency scores were determined. Repeatability and reproducibility were evaluated. Overall coefficient of variation was 0.03. The 95% confidence limits for any future faecal subsample examined by any operator in any replica were ± 0.85% faecal dry matter. Robustness in relation to weight of wet faeces was evaluated. The weight categories were 0.5, 1.0, 1.5, 2.0 and 3.0 g. Samples of 0.5 g gave significantly different mean faecal dry matter content compared to weighing of 1.0-3.0 g. Agreement with freeze-drying was evaluated. Lin's concordance correlation coefficient was 0.94. On average the faecal dry matter values was 1.7% (SD=1.99%) higher in freeze dried compared to micro waved samples. Non-parametric ROC analyses were used to determine optimal faecal dry matter cut-off values for clinical faecal consistency scores. The 4 consistency scores were score 1=firm and shaped, score 2=soft and shaped, score 3=loose and score 4=watery. The cut-off values were score 1: faecal dry matter content >19.5%, score 2: faecal dry matter content ≤ 19.5% and >18.0%, score 3: faecal dry matter content ≤ 18.0% and >11.3%, score 4: faecal dry matter content ≤ 11.3%. In conclusion, the microwave procedure has an acceptable repeatability/reproducibility and good agreement with freeze drying can be expected. A minimum of 1.0 g of wet faeces must be used for analyses. Faecal dry matter cut-off values between 4 different clinical consistency scores were determined. © 2011 Elsevier B.V. All rights reserved.

Curtailing the high rate of late-stage attrition of investigational therapeutics against unprecedented targets in patients with lung and other malignancies.

PubMed

Rowinsky, Eric K

2004-06-15

A greater understanding of the pathogenesis and biology of cancer coupled with major advances in biotechnology has resulted in the identification of rationally designed, target-based (RDTB) anticancer therapeutics, ushering in new therapeutic opportunities and high expectations for the future as well as developmental challenges. Because these agents appear to principally target malignant cells, it is expected that they will produce less toxicity at clinically effective doses than nonspecific cytotoxic agents, but their target requirements are likely to be much more stringent. The innate complexity of the networks that contain elements targeted by these agents also decreases the probability that any single therapeutic manipulation will result in robust clinical activity and success when used alone, particularly in patients with solid malignancies that have multiple relevant signaling aberrations. In contrast, proof of principle and robust antitumor activity may be most efficiently demonstrated in nonrandomized evaluations involving tumors that are principally driven by aberrations of the specific target. The predominant therapeutic manifestation of RDTB agents in preclinical studies is due to decreased tumor growth rates and will likely be similar in the clinic; however, such manifestations are not readily detectable and quantifiable using nonrandomized clinical evaluations. To curtail the increasing rate of late-stage attrition of RDTB agents, which, if maintained, will stymie progress in cancer therapy, the design of initial nonrandomized evaluations, particularly the selection of tumors and patients, must be guided by the principal biological features of the agents. Next, evaluations, some of which must be randomized, can be performed in a wide range of tumor types, depending on the presence and relevance of the target. To validate the concept of RDTB therapeutics and to realize their full potential, radically different development, evaluation, and regulatory paradigms must be adopted.

Identifying clinical learning needs using structured group feedback: first year evaluation of pre-registration nursing and midwifery degree programmes.

PubMed

Frazer, Kate; Connolly, Michael; Naughton, Corina; Kow, Veronica

2014-07-01

Facilitating and supporting clinical learning for student nurses and midwives are essential within their practice environments. Clinical placements provide unique opportunities in preparation for future roles. Understanding the experiences of first year student nurses and midwives following clinical exposures and examining the clinical facilitators and barriers can assist in maintaining and developing clinical supports. The study used a structured group feedback approach with a convenience sample of 223 first year nursing and midwifery students in one Irish university in April 2011 to ascertain feedback on the clinical aspects of their degree programme. Approximately 200 students participated in the process. Two key clinical issues were identified by students: facilitating clinical learning and learning experiences and needs. Positive learning environments, supportive staff and increased opportunities for reflection were important issues for first year students. The role of supportive mentoring staff in clinical practice is essential to enhance student learning. Students value reflection in practice and require more opportunities to engage during placements. More collaborative approaches are required to ensure evolving and adapting practice environments can accommodate student learning. Copyright © 2014 Elsevier Ltd. All rights reserved.

Emergency recompression: clinical audit of service delivery at a national level.

PubMed

Ross, John As; Sayer, Martin Dj

2009-03-01

Clinical audit is an essential element to the maintenance or improvement of delivery of any medical service. During the development phase of a National Recompression Registration Service for Scotland, clinical audit was initiated to provide a standardised tool to monitor the quality of outcome with respect to the severity of presentation. A functional audit process was an essential consideration for planned future measurement of treatment efficacy at local (single hyperbaric unit) and national (multiple hyperbaric units) scales. The audit process was designed to be undemanding, robust and informative, irrespective of the experience of treatment centre and of the clinician in charge of treatment. The clinical records from 104 cases of divers with decompression illness were used to derive and evaluate measures of severity and clinical outcome that could be used for audit and quality assurance. The various measures of disease severity were examined against clinical outcome and days spent in care after admission to a hyperbaric unit. An initial version of the clinical audit format that was developed from this process is presented.

Usability study of clinical exome analysis software: top lessons learned and recommendations.

PubMed

Shyr, Casper; Kushniruk, Andre; Wasserman, Wyeth W

2014-10-01

New DNA sequencing technologies have revolutionized the search for genetic disruptions. Targeted sequencing of all protein coding regions of the genome, called exome analysis, is actively used in research-oriented genetics clinics, with the transition to exomes as a standard procedure underway. This transition is challenging; identification of potentially causal mutation(s) amongst ∼10(6) variants requires specialized computation in combination with expert assessment. This study analyzes the usability of user interfaces for clinical exome analysis software. There are two study objectives: (1) To ascertain the key features of successful user interfaces for clinical exome analysis software based on the perspective of expert clinical geneticists, (2) To assess user-system interactions in order to reveal strengths and weaknesses of existing software, inform future design, and accelerate the clinical uptake of exome analysis. Surveys, interviews, and cognitive task analysis were performed for the assessment of two next-generation exome sequence analysis software packages. The subjects included ten clinical geneticists who interacted with the software packages using the "think aloud" method. Subjects' interactions with the software were recorded in their clinical office within an urban research and teaching hospital. All major user interface events (from the user interactions with the packages) were time-stamped and annotated with coding categories to identify usability issues in order to characterize desired features and deficiencies in the user experience. We detected 193 usability issues, the majority of which concern interface layout and navigation, and the resolution of reports. Our study highlights gaps in specific software features typical within exome analysis. The clinicians perform best when the flow of the system is structured into well-defined yet customizable layers for incorporation within the clinical workflow. The results highlight opportunities to dramatically accelerate clinician analysis and interpretation of patient genomic data. We present the first application of usability methods to evaluate software interfaces in the context of exome analysis. Our results highlight how the study of user responses can lead to identification of usability issues and challenges and reveal software reengineering opportunities for improving clinical next-generation sequencing analysis. While the evaluation focused on two distinctive software tools, the results are general and should inform active and future software development for genome analysis software. As large-scale genome analysis becomes increasingly common in healthcare, it is critical that efficient and effective software interfaces are provided to accelerate clinical adoption of the technology. Implications for improved design of such applications are discussed. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Building Capacity for Complementary and Integrative Medicine Through a Large, Cross-Agency, Acupuncture Training Program: Lessons Learned from a Military Health System and Veterans Health Administration Joint Initiative Project.

PubMed

Niemtzow, Richard; Baxter, John; Gallagher, Rollin M; Pock, Arnyce; Calabria, Kathryn; Drake, David; Galloway, Kevin; Walter, Joan; Petri, Richard; Piazza, Thomas; Burns, Stephen; Hofmann, Lew; Biery, John; Buckenmaier, Chester

2018-03-26

Complementary and integrative medicine (CIM) use in the USA continues to expand, including within the Military Health System (MHS) and Veterans Health Administration (VHA). To mitigate the opioid crisis and provide additional non-pharmacological pain management options, a large cross-agency collaborative project sought to develop and implement a systems-wide curriculum, entitled Acupuncture Training Across Clinical Settings (ATACS). ATACS curriculum content and structure were created and refined over the course of the project in response to consultations with Subject Matter Experts and provider feedback. Course content was developed to be applicable to the MHS and VHA environments and training was open to many types of providers. Training included a 4-hr didactic and "hands on" clinical training program focused on a single auricular acupuncture protocol, Battlefield Acupuncture. Trainee learning and skills proficiency were evaluated by trainer-observation and written examination. Immediately following training, providers completed an evaluation survey on their ATACS experience. One month later, they were asked to complete another survey regarding their auricular acupuncture use and barriers to use. The present evaluation describes the ATACS curriculum, faculty and trainee characteristics, as well as trainee and program developer perspectives. Over the course of a 19-mo period, 2,712 providers completed the in-person, 4-hr didactic and hands-on clinical training session. Due to the increasing requests for training, additional ATACS faculty were trained. Overall, 113 providers were approved to be training faculty. Responses from the trainee surveys indicated high satisfaction with the ATACS training program and illuminated several challenges to using auricular acupuncture with patients. The most common reported barrier to using auricular acupuncture was the lack of obtaining privileges to administer auricular acupuncture within clinical practice. The ATACS program provided a foundational template to increase CIM across the MHS and VHA. The lessons learned in the program's implementation will aid future CIM training programs and improve program evaluations. Future work is needed to determine the most efficient means of improving CIM credentialing and privileging procedures, standardizing and adopting uniform CIM EHR codes and documentation, and examining the effectiveness of CIM techniques in real-world settings.

Implementation of workflow engine technology to deliver basic clinical decision support functionality

PubMed Central

2011-01-01

Background Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. Results We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. Conclusions We describe an implementation of a free workflow technology software suite (available at http://code.google.com/p/healthflow) and its application in the domain of clinical decision support. Our implementation seamlessly supports clinical logic testing on retrospective data and offers a user-friendly knowledge representation paradigm. With the presented software implementation, we demonstrate that workflow engine technology can provide a decision support platform which evaluates well against an established clinical decision support architecture evaluation framework. Due to cross-industry usage of workflow engine technology, we can expect significant future functionality enhancements that will further improve the technology's capacity to serve as a clinical decision support platform. PMID:21477364

Passing the baton: a grounded practical theory of handoff communication between multidisciplinary providers in two Department of Veterans Affairs outpatient settings.

PubMed

Koenig, Christopher J; Maguen, Shira; Daley, Aaron; Cohen, Greg; Seal, Karen H

2013-01-01

Handoffs are communication processes that enact the transfer of responsibility between providers across clinical settings. Prior research on handoff communication has focused on inpatient settings between provider teams and has emphasized patient safety. This study examines handoff communication within multidisciplinary provider teams in two outpatient settings. To conduct an exploratory study that describes handoff communication among multidisciplinary providers, to develop a theory-driven descriptive framework for outpatient handoffs, and to evaluate the strengths and weaknesses of different handoff types. Qualitative, in-depth, semi-structured interviews with 31 primary care, mental health, and social work providers in two Department of Veterans Affairs (VA) Medical Center outpatient clinics. Audio-recorded interviews were transcribed and analyzed using Grounded Practical Theory to develop a theoretical model of and a descriptive framework for handoff communication among multidisciplinary providers. Multidisciplinary providers reported that handoff decisions across settings were made spontaneously and without clear guidelines. Two situated values, clinic efficiency and patient-centeredness, shaped multidisciplinary providers' handoff decisions. Providers reported three handoff techniques along a continuum: the electronic handoff, which was the most clinically efficient; the provider-to-provider handoff, which balanced clinic efficiency and patient-centeredness; and the collaborative handoff, which was the most patient-centered. Providers described handoff choice as a practical response to manage constituent features of clinic efficiency (time, space, medium of communication) and patient-centeredness (information continuity, management continuity, relational continuity, and social interaction). We present a theoretical and descriptive framework to help providers evaluate differential handoff use, reflect on situated values guiding clinic communication, and guide future research. Handoff communication reflected multidisciplinary providers' efforts to balance clinic efficiency with patient-centeredness within the constraints of day-to-day clinical practice. Evaluating the strengths and weaknesses among alternative handoff options may enhance multidisciplinary provider handoff decision-making and may contribute to increased coordination and continuity of care across outpatient settings.

An evaluation of multimedia and online support groups (OSG) contents and application of information by infertile patients: Mixed method study

NASA Astrophysics Data System (ADS)

Wiweko, Budi; Narasati, Shabrina; Agung, Prince Gusti; Zesario, Aulia; Wibawa, Yohanes Satrya; Maidarti, Mila; Harzif, Achmad Kemal; Pratama, Gita; Sumapradja, Kanadi; Muharam, Raden; Hestiantoro, Andon

2018-02-01

Background: The presence of Online Support Groups (OSG) is expected to empower patients with infertility, thus allowing patients to be the focus of healthcare services. This study will evaluate multimedia content, OSG, and utilization of information for decision-making by patients using infertility services. This study is a mixed method study conducted from January - June 2016 at Yasmin IVF Clinic, Dr. Cipto Mangunkusumo General Hospital; and SMART IVF Clinic, Jakarta. The subjects are patients with infertility who sought treatment at the clinics. Data was collected through a structured interview in the form of a questionnaire. Informed consent was obtained from all individual participants included in the study. All procedures that performed in studies were by the ethical standards of the institutional. The result from 72 respondents showed quantitative analysis did not reveal any association between multimedia and OSG information sources with patient knowledge regarding infertility management. However, qualitative analysis highlighted three issues: the information regarding infertility services in the available multimedia and the OSG; use of the available information by patients when deciding to use infertility services. The level of awareness of respondents on searching information regarding infertility on the clinic website is still limited. It happened because most of the patients in the clinic are unaware of clinic website existence which provided the infertility information. Therefore, the clinic website needs to be promoted so the usage of this website will increase in the future.

Clinical evaluation of liquid placebos for an herbal supplement, STW5, in healthy volunteers.

PubMed

Yoon, Saunjoo L; Grundmann, Oliver; Keane, Devan; Urbano, Theodore; Moshiree, Baharak

2012-10-01

Although clinical trials are needed to evaluate the efficacy of liquid herbal medicinal products, design of feasible placebos that mimic the appearance, taste, and smell of such products is particularly challenging. The design and feasibility of a liquid placebo for STW5, an herbal medicinal product used for various gastrointestinal problems, was explored in this study. Four sample products-STW5, a fresh and aged version of a placebo made from a seasoning mix (Maggi™), and a placebo with aged artificial flavor and food coloring-were compared in two organoleptic (sensory), single-blind trials with a total of 60 (N=60) healthy volunteers (n(1)=30, n(2)=30). The appearance, smell, and taste of each solution were evaluated using a Likert scale questionnaire. The liquid placebos evaluated were similar in regard to appearance, smell, and taste. However, participants indicated that for a clinical trial with STW5, the aged Maggi™ placebo would be more viable compared to the fresh Maggi placebo or the aged artificial food coloring placebo with licorice flavor. Participants also noted that the mint flavor and smell of STW5 was distinctly different from the placebo solutions. The trials were conducted in healthy volunteers, not in actual patients. The aged Maggi™ liquid mix may be more favorable as a placebo than the artificially created one. However, further adjustment will need to be made to the Maggi™ placebo to simulate the complex aromatic composition of STW5 for clinical studies in the future. Copyright © 2012 Elsevier Ltd. All rights reserved.

Management of an affiliated Physics Residency Program using a commercial software tool.

PubMed

Zacarias, Albert S; Mills, Michael D

2010-06-01

A review of commercially available allied health educational management software tools was performed to evaluate their capacity to manage program data associated with a CAMPEP-accredited Therapy Physics Residency Program. Features of these software tools include: a) didactic course reporting and organization, b) competency reporting by topic, category and didactic course, c) student time management and accounting, and d) student patient case reporting by topic, category and course. The software package includes features for recording school administrative information; setting up lists of courses, faculty, clinical sites, categories, competencies, and time logs; and the inclusion of standardized external documents. There are provisions for developing evaluation and survey instruments. The mentors and program may be evaluated by residents, and residents may be evaluated by faculty members using this feature. Competency documentation includes the time spent on the problem or with the patient, time spent with the mentor, date of the competency, and approval by the mentor and program director. Course documentation includes course and lecture title, lecturer, topic information, date of lecture and approval by the Program Director. These software tools have the facility to include multiple clinical sites, with local subadministrators having the ability to approve competencies and attendance at clinical conferences. In total, these software tools have the capability of managing all components of a CAMPEP-accredited residency program. The application database lends the software to the support of multiple affiliated clinical sites within a single residency program. Such tools are a critical and necessary component if the medical physics profession is to meet the projected needs for qualified medical physicists in future years.

The assessment, serial evaluation, and subsequent sequelae of acute kidney injury (ASSESS-AKI) study: design and methods.

PubMed

Go, Alan S; Parikh, Chirag R; Ikizler, T Alp; Coca, Steven; Siew, Edward D; Chinchilli, Vernon M; Hsu, Chi-Yuan; Garg, Amit X; Zappitelli, Michael; Liu, Kathleen D; Reeves, W Brian; Ghahramani, Nasrollah; Devarajan, Prasad; Faulkner, Georgia Brown; Tan, Thida C; Kimmel, Paul L; Eggers, Paul; Stokes, John B

2010-08-27

The incidence of acute kidney injury (AKI) has been increasing over time and is associated with a high risk of short-term death. Previous studies on hospital-acquired AKI have important methodological limitations, especially their retrospective study designs and limited ability to control for potential confounding factors. The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study was established to examine how a hospitalized episode of AKI independently affects the risk of chronic kidney disease development and progression, cardiovascular events, death, and other important patient-centered outcomes. This prospective study will enroll a cohort of 1100 adult participants with a broad range of AKI and matched hospitalized participants without AKI at three Clinical Research Centers, as well as 100 children undergoing cardiac surgery at three Clinical Research Centers. Participants will be followed for up to four years, and will undergo serial evaluation during the index hospitalization, at three months post-hospitalization, and at annual clinic visits, with telephone interviews occurring during the intervening six-month intervals. Biospecimens will be collected at each visit, along with information on lifestyle behaviors, quality of life and functional status, cognitive function, receipt of therapies, interim renal and cardiovascular events, electrocardiography and urinalysis. ASSESS-AKI will characterize the short-term and long-term natural history of AKI, evaluate the incremental utility of novel blood and urine biomarkers to refine the diagnosis and prognosis of AKI, and identify a subset of high-risk patients who could be targeted for future clinical trials to improve outcomes after AKI.

Discharge clinical characteristics and 60-day readmission in patients hospitalized with heart failure.

PubMed

Anderson, Kelley M

2014-01-01

Heart failure is a clinical syndrome that incurs a high prevalence, mortality, morbidity, and economic burden in our society. Patients with heart failure may experience hospitalization because of an acute exacerbation of their condition. Recurrent hospitalizations soon after discharge are an unfortunate occurrence in this patient population. The purpose of this study was to explore the clinical and diagnostic characteristics of individuals hospitalized with a primary diagnosis of heart failure at the time of discharge and to compare the association of these indicators in individuals who did and did not experience a heart failure hospitalization within 60 days of the index stay. The study is a descriptive, correlational, quantitative study using a retrospective review of 134 individuals discharged with a primary diagnosis of heart failure. Records were reviewed for sociodemographic characteristics, health histories, clinical assessment findings, and diagnostic information. Significant predictors of 60-day heart failure readmissions were dyspnea (β = 0.579), crackles (β = 1.688), and assistance with activities of daily living (β = 2.328), independent of age, gender, and multiple other factors. By using hierarchical logistical regression, a model was derived that demonstrated the ability to correctly classify 77.4% of the cohort, 78.2% of those who did have a readmission (sensitivity of the prediction), and 76.7% of the subjects in whom the predicted event, readmission, did not occur (specificity of the prediction). Hospitalizations for heart failure are markers of clinical instability. Future events after hospitalization are common in this patient population, and this study provides a novel understanding of clinical characteristics at the time of discharge that are associated with future outcomes, specifically 60-day heart failure readmissions. A consideration of these characteristics provides an additional perspective to guide clinical decision making and the evaluation of discharge readiness.

Trying on the professional self: nursing students' perceptions of learning about roles, identity and teamwork in an interprofessional clinical placement.

PubMed

Hood, Kerry; Cant, Robyn; Leech, Michelle; Baulch, Julie; Gilbee, Alana

2014-05-01

This study aims to describe how senior nursing students viewed the clinical learning environment and matured their professional identity through interprofessional learning in a student-led hospital 'ward'. Undergraduate nursing and medical student teams participated in a trial of ward-based interprofessional clinical learning, managing patients over 2 weeks in a rehabilitation ward. Qualitative and quantitative program evaluation was conducted using exit student focus groups and a satisfaction survey. Twenty-three nursing and medical students in three placement rounds provided positive feedback. Five main themes emerged describing their engagement in 'trying on' a professional role: 'experiencing independence and autonomy'; 'seeing clearly what nursing's all about'; 'altered images of other professions'; 'ways of communicating and collaborating' and 'becoming a functioning team'. Ward-based interprofessional clinical placements offer senior students authentic ideal clinical experiences. We consider this essential learning for future interprofessional collaboration which should be included in senior nursing students' education. © 2014.

The physical therapy clinical research network (PTClinResNet): methods, efficacy, and benefits of a rehabilitation research network.

PubMed

Winstein, Carolee; Pate, Patricia; Ge, Tingting; Ervin, Carolyn; Baurley, James; Sullivan, Katherine J; Underwood, Samantha J; Fowler, Eileen G; Mulroy, Sara; Brown, David A; Kulig, Kornelia; Gordon, James; Azen, Stanley P

2008-11-01

This article describes the vision, methods, and implementation strategies used in building the infrastructure for PTClinResNet, a clinical research network designed to assess outcomes for health-related mobility associated with evidence-based physical therapy interventions across and within four different disability groups. Specific aims were to (1) create the infrastructure necessary to develop and sustain clinical trials research in rehabilitation, (2) generate evidence to evaluate the efficacy of resistance exercise-based physical interventions designed to improve muscle performance and movement skills, and (3) provide education and training opportunities for present and future clinician-researchers and for the rehabilitation community at-large in its support of evidence-based practice. We present the network's infrastructure, development, and several examples that highlight the benefits of a clinical research network. We suggest that the network structure is ideal for building research capacity and fostering multisite, multiinvestigator clinical research projects designed to generate evidence for the efficacy of rehabilitation interventions.

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

PubMed

Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

2011-12-01

New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

PubMed Central

Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

2013-01-01

New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

PubMed

Maeda, Kojiro; Kaneko, Masayuki; Narukawa, Mamoru; Arato, Teruyo

2017-08-23

The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. The development of ultra-orphan drugs requires various arrangements regarding evidence collection, data sources and the clinical trial design. We expect that this draft guidance is useful for ultra-orphan drugs developments in future.

Clinical descriptors for the recognition of central sensitization pain in patients with knee osteoarthritis.

PubMed

Lluch, Enrique; Nijs, Jo; Courtney, Carol A; Rebbeck, Trudy; Wylde, Vikki; Baert, Isabel; Wideman, Timothy H; Howells, Nick; Skou, Søren T

2017-08-02

Despite growing awareness of the contribution of central pain mechanisms to knee osteoarthritis pain in a subgroup of patients, routine evaluation of central sensitization is yet to be incorporated into clinical practice. The objective of this perspective is to design a set of clinical descriptors for the recognition of central sensitization in patients with knee osteoarthritis that can be implemented in clinical practice. A narrative review of original research papers was conducted by nine clinicians and researchers from seven different countries to reach agreement on clinically relevant descriptors. It is proposed that identification of a dominance of central sensitization pain is based on descriptors derived from the subjective assessment and the physical examination. In the former, clinicians are recommended to inquire about intensity and duration of pain and its association with structural joint changes, pain distribution, behavior of knee pain, presence of neuropathic-like or centrally mediated symptoms and responsiveness to previous treatment. The latter includes assessment of response to clinical test, mechanical hyperalgesia and allodynia, thermal hyperalgesia, hypoesthesia and reduced vibration sense. This article describes a set of clinically relevant descriptors that might indicate the presence of central sensitization in patients with knee osteoarthritis in clinical practice. Although based on research data, the descriptors proposed in this review require experimental testing in future studies. Implications for Rehabilitation Laboratory evaluation of central sensitization for people with knee osteoarthritis is yet to be incorporated into clinical practice. A set of clinical indicators for the recognition of central sensitization in patients with knee osteoarthritis is proposed. Although based on research data, the clinical indicators proposed require further experimental testing of psychometric properties.

The Observed Longitudinal Relationship between Future Orientation and Substance Use Among a Cohort of Youth with Serious Criminal Offenses.

PubMed

Brooks, Merrian; Miller, Elizabeth; Abebe, Kaleab; Mulvey, Edward

2018-03-06

Future orientation (FO), an essential construct in youth development, encompassing goals, expectations for life, and ability to plan for the future. This study uses a multidimensional measure of future orientation to assess the relationship between change in future orientation and change in substance use over time. Data were from the Pathways to Desistence study. Justice involved youth (n = 1,354), ages 14 to 18 at time of recruitment, completed interviews every six months for three years. Multiple measures were chosen a priori as elements of future orientation. After evaluating the psychometrics of a new measure for future orientation, we ran mixed effects cross-lagged panel models to assess the relationship between changes in future orientation and substance use (tobacco, marijuana, hard drugs, and alcohol). There was a significant bidirectional relationship between future orientation and all substance use outcomes. Adjusted models accounted for different sites, sex, age, ethnicity, parental education, and proportion of time spent in a facility. In adjusted models, higher levels of future orientation resulted in smaller increases in substance use at future time points. Future orientation and substance use influence each other in this sample of adolescent offenders. Treating substance use disorders is also likely to increase future orientation, promoting positive youth development more generally. This study expands our understanding of the longitudinal relationship between changes in future orientation and changes in levels of substance use in a sample of justice involved youth with high levels of substance use, a group of considerable clinical and policy interest.

Graphene Materials in Antimicrobial Nanomedicine: Current Status and Future Perspectives.

PubMed

Karahan, Hüseyin Enis; Wiraja, Christian; Xu, Chenjie; Wei, Jun; Wang, Yilei; Wang, Liang; Liu, Fei; Chen, Yuan

2018-03-05

Graphene materials (GMs), such as graphene, graphene oxide (GO), reduced GO (rGO), and graphene quantum dots (GQDs), are rapidly emerging as a new class of broad-spectrum antimicrobial agents. This report describes their state-of-the-art and potential future covering both fundamental aspects and biomedical applications. First, the current understanding of the antimicrobial mechanisms of GMs is illustrated, and the complex picture of underlying structure-property-activity relationships is sketched. Next, the different modes of utilization of antimicrobial GMs are explained, which include their use as colloidal dispersions, surface coatings, and photothermal/photodynamic therapy agents. Due to their practical relevance, the examples where GMs function as synergistic agents or release platforms for metal ions and/or antibiotic drugs are also discussed. Later, the applicability of GMs in the design of wound dressings, infection-protective coatings, and antibiotic-like formulations ("nanoantibiotics") is assessed. Notably, to support our assessments, the existing clinical applications of conventional carbon materials are also evaluated. Finally, the key hurdles of the field are highlighted, and several possible directions for future investigations are proposed. We hope that the roadmap provided here will encourage researchers to tackle remaining challenges toward clinical translation of promising research findings and help realize the potential of GMs in antimicrobial nanomedicine. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[The directional axes in the reform of medical teaching. A strategic proposal].

PubMed

Martins e Silva, J

1993-10-01

The circumstances preceding the future revision of the medical curriculum are analysed, main internal and external stimuli are described, and sources of resistance to changes in medical training require new educational philosophy, privileging oriented training during undergraduation, as a preliminary phase of medical education. The definition and accompaniment of the general and specific objectives, the strategy and programme used, the design and adequacy of the available support, and the related engagement of all political, academic and socially responsible persons and institutions, are fundamental factors for successful change. The education and training of polyvalent medical doctors requires methodological modifications, namely the definition of a core curriculum, made dynamic through the teaching of interdependent subjects and earlier contact with common clinical problems. Learning through interconnected basic and clinical matters will benefit the technical and psychosocial education of future doctors. The education resulting from a renewal in undergraduate medical education will be mostly determined by organizational and institutional frameworks, teaching methods and the evaluation process used, as well as by teacher commitment, pedagogic and scientific capacities. Professional competence should be the end product of efficient training. Otherwise, undergraduate medical education would not prepare the professional development of the young doctors, thus diminishing the quality of medical training in the future.

A 71-year-old man with anaphylaxis after eating grits

PubMed Central

Posthumus, Jonathon; Borish, Larry

2014-01-01

The allergist is frequently called on to evaluate patients after episodes of anaphylaxis to determine the cause and implement preventive measures that will reduce the patient’s risk from future episodes. The etiology of anaphylaxis can be the result of numerous causes that may go undiagnosed if a thorough evaluation is not performed. We present a 71-year-old man with no history of food allergy or atopy who presented to the emergency room and then our allergy clinic for evaluation after suffering anaphylaxis after a meal of grits and shrimp. The underlying diagnosis, which was subsequently determined, requires a high index of suspicion and should be included in the differential diagnosis of any patient presenting with unexplained anaphylaxis. PMID:22370536

Whittling Down the Wait Time: Exploring Models to Minimize the Delay from Initial Concern to Diagnosis and Treatment of Autism Spectrum Disorder.

PubMed

Gordon-Lipkin, Eliza; Foster, Jessica; Peacock, Georgina

2016-10-01

The process from initial concerns to diagnosis of autism spectrum disorder (ASD) can be a long and complicated process. The traditional model for evaluation and diagnosis of ASD often consists of long wait-lists and evaluations that result in a 2-year difference between the earliest signs of ASD and mean age of diagnosis. Multiple factors contribute to this diagnostic bottleneck, including time-consuming evaluations, cost of care, lack of providers, and lack of comfort of primary care providers to diagnose autism. This article explores innovative clinical models that have been implemented to address this as well as future directions and opportunities. Copyright © 2016 Elsevier Inc. All rights reserved.

KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors

PubMed Central

Lentine, Krista L.; Kasiske, Bertram L.; Levey, Andrew S.; Adams, Patricia L.; Alberú, Josefina; Bakr, Mohamed A.; Gallon, Lorenzo; Garvey, Catherine A.; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L.; Taler, Sandra J.; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G.; Cheung, Michael; Garg, Amit X.

2017-01-01

Abstract The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a “proof-in-concept” risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided. In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017;101(Suppl 8S):S1–S109. PMID:28742762

[Evaluation of Gastric Mucosal Injury Model Animals of Rebamipide Formulation--Study of Therapeutic Equivalence].

PubMed

Abe, Noriaki; Funato, Hiroki; Hirata, Ayumu; Nakai, Megumi; Iizuka, Michiro; Shiraishi, Hisashi; Jobu, Kohei; Yagi, Yusuke; Kadota, Aki; Ogi, Kyoko; Yokota, Junko; Miyamura, Mitsuhiko

2016-01-01

The introduction of generic drugs is promoted from the perspective of medical economics. In this context, we need to understand not only the bioequivalence of generic drugs specified in "the Guidelines for Bioequivalence Studies of Generic Products", but also formulation properties to consider their effect on pharmacological therapy. We evaluated the pharmaceutical characteristics of rebamipide formulations, a brand-name drug and two generic drugs, and their clinical functionality by using rat models of gastric mucosal injury induced by non-steroidal anti-inflammatory drugs (NSAIDs). Pharmaceutical evaluation showed significant differences in hardness. The inter-lot variation was small in all rebamipide formulations. In the clinical functionality study, biochemistry test values 7 d after the administration of rebamipide showed no differences among formulations. Higher levels of mucosal fluid secretion and antioxidative enzymes were observed in the groups administered rebamipide than in the control group. The levels of lipid peroxide were lower in the groups administered rebamipide than the control group. Multivariate analysis showed slight divergence between the brand-name and generic drugs. In future, it will be necessary to select generic drugs after careful consideration of bioequivalence, clinical functionality, and therapeutic equivalence by reviewing scientific evidence such as indication and formulation design, not to mention stable provision.

Evaluation Metrics for Biostatistical and Epidemiological Collaborations

PubMed Central

Rubio, Doris McGartland; del Junco, Deborah J.; Bhore, Rafia; Lindsell, Christopher J.; Oster, Robert A.; Wittkowski, Knut M.; Welty, Leah J.; Li, Yi-Ju; DeMets, Dave

2011-01-01

Increasing demands for evidence-based medicine and for the translation of biomedical research into individual and public health benefit have been accompanied by the proliferation of special units that offer expertise in biostatistics, epidemiology, and research design (BERD) within academic health centers. Objective metrics that can be used to evaluate, track, and improve the performance of these BERD units are critical to their successful establishment and sustainable future. To develop a set of reliable but versatile metrics that can be adapted easily to different environments and evolving needs, we consulted with members of BERD units from the consortium of academic health centers funded by the Clinical and Translational Science Award Program of the National Institutes of Health. Through a systematic process of consensus building and document drafting, we formulated metrics that covered the three identified domains of BERD practices: the development and maintenance of collaborations with clinical and translational science investigators, the application of BERD-related methods to clinical and translational research, and the discovery of novel BERD-related methodologies. In this article, we describe the set of metrics and advocate their use for evaluating BERD practices. The routine application, comparison of findings across diverse BERD units, and ongoing refinement of the metrics will identify trends, facilitate meaningful changes, and ultimately enhance the contribution of BERD activities to biomedical research. PMID:21284015

Clinical evaluation and mutational analysis of GALK and GALE genes in patients with galactosemia in Greece: one novel mutation and two rare cases.

PubMed

Schulpis, Kleopatra H; Thodi, Georgia; Iakovou, Konstantinos; Chatzidaki, Maria; Dotsikas, Yannis; Molou, Elina; Triantafylli, Olga; Loukas, Yannis L

2017-07-26

Deficiencies of galactokinase (GALK) and UDP-epimerase (GALE) are implicated with galactose metabolic disorders. The aim of the study was the identification of mutations in GALK and GALE genes and clinical evaluation of patients. Five patients with GALK and five with GALE deficiency were picked up via the Neonatal Screening Program. Additionally, two females, 4 years old, were referred with late diagnosed galactosemia, as rare cases. Mutational analysis was conducted via Sanger sequencing, while in silico analysis tools were utilized for the novel mutation. Psychomotor and speech development tests were performed, as well. The mutation p.Pro28Thr was identified in both alleles in GALK-deficient patients of Roma (gypsy) origin, whereas the novel p.Asn39Ser was detected in two non-Roma patients. In GALE-deficient patients benign and/or likely benign mutations were found. Psychomotor and speech delay were determined in the Roma GALK patients. In each of the late diagnosed females, four mutations were identified in all galactosemia-related genes. The mutational spectrums of GALE- and GALK-deficient patients in Greece are presented for the first time along with a clinical evaluation. Mutational analysis in all galactosemia-related genes of symptomatic patients is highly recommended for future cases.

Is Episodic Future Thinking Important for Instrumental Activities of Daily Living? A Study in Neurological Patients and Healthy Older Adults.

PubMed

Brunette, Amanda M; Calamia, Matthew; Black, Jenah; Tranel, Daniel

2018-06-11

Episodic future thinking is the ability to mentally project oneself into the future. This construct has been explored extensively in cognitive neuroscience and may be relevant for adaptive functioning. However, it has not been determined whether the measurement of episodic future thinking might be valuable in a clinical neuropsychological setting. The current study investigated (1) the relationship between episodic future thinking and instrumental activities of daily living (IADLs); and (2) whether episodic future thinking is related to IADLs over and above standard measures of cognition. Sixty-one older adults with heterogeneous neurological conditions and 41 healthy older adults completed a future thinking task (the adapted Autobiographical Interview), a performance-based measure of instrumental activities of daily living (the Independent Living Scales), and standard clinical measures of memory and executive functioning. Episodic future thinking significantly predicted IADLs after accounting for age, education, gender, and depression (increase in R2 = .050, p = .010). Episodic future thinking significantly predicted IADLs over and above executive functioning (increase in R2 = .025, p = .030), but was not predictive of IADLs over and above memory (p = .157). This study suggests that episodic future thinking is significantly associated with IADLs, beyond what can be accounted for by executive functioning. However, episodic future thinking did not predict IADLs over and above memory. Overall, there is limited evidence for the clinical utility of episodic future thinking. The findings suggest that an episodic future thinking task does not provide enough valuable information about IADLs to justify its inclusion in a clinical neuropsychological setting.

Comparing student clinical self-efficacy and team process outcomes for a DEU, blended, and traditional clinical setting: A quasi-experimental research study.

PubMed

Plemmons, Christina; Clark, Michele; Feng, Du

2018-03-01

Clinical education is vital to both the development of clinical self-efficacy and the integration of future nurses into health care teams. The dedicated education unit clinical teaching model is an innovative clinical partnership, which promotes skill development, professional growth, clinical self-efficacy, and integration as a team member. Blended clinical teaching models are combining features of the dedicated education unit and traditional clinical model. The aims of this study are to explore how each of three clinical teaching models (dedicated education unit, blended, traditional) affects clinical self-efficacy and attitude toward team process, and to compare the dedicated education unit model and blended model to traditional clinical. A nonequivalent control-group quasi-experimental design was utilized. The convenience sample of 272 entry-level baccalaureate nursing students included 84 students participating in a dedicated education unit model treatment group, 66 students participating in a blended model treatment group, and 122 students participating in a traditional model control group. Perceived clinical self-efficacy was evaluated by the pretest/posttest scores obtained on the General Self-Efficacy scale. Attitude toward team process was evaluated by the pretest/posttest scores obtained on the TeamSTEPPS® Teamwork Attitude Questionnaire. All three clinical teaching models resulted in significant increases in both clinical self-efficacy (p=0.04) and attitude toward team process (p=0.003). Students participating in the dedicated education unit model (p=0.016) and students participating in the blended model (p<0.001) had significantly larger increases in clinical self-efficacy compared to students participating in the traditional model. These findings support the use of dedicated education unit and blended clinical partnerships as effective alternatives to the traditional model to promote both clinical self-efficacy and team process among entry-level baccalaureate nursing students. Copyright © 2017 Elsevier Ltd. All rights reserved.

Poly(amido amine) dendrimers in oral delivery.

PubMed

Yellepeddi, Venkata K; Ghandehari, Hamidreza

2016-01-01

Poly(amidoamine) (PAMAM) dendrimers have been extensively investigated for oral delivery applications due to their ability to translocate across the gastrointestinal epithelium. In this Review, we highlight recent advances in the evaluation of PAMAM dendrimers as oral drug delivery carriers. Specifically, toxicity, mechanisms of transepithelial transport, models of the intestinal epithelial barrier including isolated human intestinal tissue model, detection of dendrimers, and surface modification are discussed. We also highlight evaluation of various PAMAM dendrimer-drug conjugates for their ability to transport across gastrointestinal epithelium for improved oral bioavailability. In addition, current challenges and future trends for clinical translation of PAMAM dendrimers as carriers for oral delivery are discussed.

Potential new treatments for diabetic kidney disease.

PubMed

Kania, Deanna S; Smith, Cory T; Nash, Christy L; Gonzalvo, Jasmine D; Bittner, Andrea; Shepler, Brian M

2013-01-01

Antifibrotic agents, antioxidant agents, ET-a receptor antagonists, and a few other agents with nonspecific or multifaceted mechanisms of action have been evaluated and progressed to small clinical studies in human subjects. Although there are limited data at the present time, these early evaluations have produced some favorable results that at least warrant further investigation. There is certainly not enough compelling evidence to justify the routine use of any of these products specifically for DKD at the moment; however, more well-controlled and adequately powered studies in several hundred patients will help determine which of these may have a place in the DKD treatment armamentarium of the future. Published by Elsevier Inc.

Poly(amido amine) dendrimers in oral delivery

PubMed Central

Yellepeddi, Venkata K.; Ghandehari, Hamidreza

2016-01-01

ABSTRACT Poly(amidoamine) (PAMAM) dendrimers have been extensively investigated for oral delivery applications due to their ability to translocate across the gastrointestinal epithelium. In this Review, we highlight recent advances in the evaluation of PAMAM dendrimers as oral drug delivery carriers. Specifically, toxicity, mechanisms of transepithelial transport, models of the intestinal epithelial barrier including isolated human intestinal tissue model, detection of dendrimers, and surface modification are discussed. We also highlight evaluation of various PAMAM dendrimer-drug conjugates for their ability to transport across gastrointestinal epithelium for improved oral bioavailability. In addition, current challenges and future trends for clinical translation of PAMAM dendrimers as carriers for oral delivery are discussed. PMID:27358755

A court-mandated workshop for adolescent children of divorcing parents: a program evaluation.

PubMed

Young, D M

1980-01-01

This article provides a description and an empirical evaluation of a predivorce workshop established by the Family Court of Allen County, Indiana, for adolescent children (N = 48) of divorcing parents. Highlighted are the concerns of the adolescents, the approaches taken by the workshop staff, and the impact of the program on the participants. Viewpoints on the clinical, ethical, and legal issues involved in "required" predivorce counseling for adolescents are presented. The preventive nature of the program, its means of transforming initial resentment toward the workshop experience into positive feelings, and the implications for future practice and research are also discussed.

Pharmacological enhancement of drug cue extinction learning: translational challenges

PubMed Central

Kantak, K.M.; Nic Dhonnchadha, B.Á.

2010-01-01

Augmentation of cue exposure (extinction) therapy with cognitive-enhancing pharmacotherapy may constitute a rational strategy for the clinical management of drug relapse. While certain success has been reported for this form of therapy in anxiety disorders, in this article we highlight several obstacles that may undermine the efficacy of exposure therapy for substance use disorders. We also review translational studies that have evaluated the facilitative effects of the cognitive enhancer D-cycloserine on extinction targeting drug-related cues. Finally, important considerations for the design and implementation of future studies evaluating exposure therapy combined with pharmacotherapy for substance use disorders are discussed. PMID:21272016

Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial

PubMed Central

Paul, Mandira; Iyengar, Kirti; Essén, Birgitta; Gemzell-Danielsson, Kristina; Iyengar, Sharad D.; Bring, Johan; Soni, Sunita; Klingberg-Allvin, Marie

2015-01-01

Background Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education. Objective To investigate women’s acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India. Design Secondary outcome of a randomised, controlled, non-inferiority trial. Setting Outpatient primary health care clinics in rural and urban Rajasthan, India. Population Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85mg/l and were below 18 years. Methods Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible. Main Outcome Measures Women’s acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups. Results 731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%), in the home-assessment group preferred home-assessment in the future, as compared with 188 (70%) of women in the clinic follow-up group, who preferred clinic follow-up in the future (p < 0.001). Conclusion Home-assessment is highly acceptable among women in low-resource, and rural, settings. The choice to follow-up an early medical abortion according to women’s preference should be offered to foster women’s reproductive autonomy. Trial Registration ClinicalTrials.gov NCT01827995 PMID:26327217

Students' voices: the lived experience of faculty incivility as a barrier to professional formation in associate degree nursing education.

PubMed

Del Prato, Darlene

2013-03-01

Nursing faculty play an important role in constructing learning environments that foster the positive formation of future nurses. The students' construction of a nursing identity is grounded in social interactions with faculty and is shaped by values and norms learned in both the formal and informal curriculum. The informal curriculum is communicated in faculty teaching practices and relationships established with students. To acquire an understanding of the students' lived experience in associate degree nursing education and identify educational practices that support students' professional formation. A phenomenological design was chosen to study the lived experience of nursing education. In-depth interviews were conducted with 13 participants. Five students participated in second interviews for a total of 18 interviews. Symbolic interactionism guided data analysis. Participants represented three ADN programs in the northeastern U.S. and were diverse in terms of gender and age and to a lesser extent race, and sexual orientation. Faculty incivility included demeaning experiences, subjective evaluation, rigid expectations, and targeting and weeding out practices. Targeting practices contributed to a perceived focus on clinical evaluation and inhibited clinical learning. Faculty incivility hindered professional formation by interfering with learning, self-esteem, self-efficacy, and confidence. Faculty who model professional values in the formal and hidden curriculum contribute to the positive formation of future nurses. Nursing faculty should be formally prepared as educators to establish respectful, connected relationships with students. Faculty should role model professional values, deemphasize their evaluative role, provide constructive formative feedback, and remain open to the student's potential for growth. Copyright © 2012 Elsevier Ltd. All rights reserved.

Touchless interaction with software in interventional radiology and surgery: a systematic literature review.

PubMed

Mewes, André; Hensen, Bennet; Wacker, Frank; Hansen, Christian

2017-02-01

In this article, we systematically examine the current state of research of systems that focus on touchless human-computer interaction in operating rooms and interventional radiology suites. We further discuss the drawbacks of current solutions and underline promising technologies for future development. A systematic literature search of scientific papers that deal with touchless control of medical software in the immediate environment of the operation room and interventional radiology suite was performed. This includes methods for touchless gesture interaction, voice control and eye tracking. Fifty-five research papers were identified and analyzed in detail including 33 journal publications. Most of the identified literature (62 %) deals with the control of medical image viewers. The others present interaction techniques for laparoscopic assistance (13 %), telerobotic assistance and operating room control (9 % each) as well as for robotic operating room assistance and intraoperative registration (3.5 % each). Only 8 systems (14.5 %) were tested in a real clinical environment, and 7 (12.7 %) were not evaluated at all. In the last 10 years, many advancements have led to robust touchless interaction approaches. However, only a few have been systematically evaluated in real operating room settings. Further research is required to cope with current limitations of touchless software interfaces in clinical environments. The main challenges for future research are the improvement and evaluation of usability and intuitiveness of touchless human-computer interaction and the full integration into productive systems as well as the reduction of necessary interaction steps and further development of hands-free interaction.

Future therapeutic directions for factor Xa inhibition in the prophylaxis and treatment of thrombotic disorders.

PubMed

Turpie, Alexander G G

2003-11-15

The targeted mechanism of factor Xa inhibition has been studied extensively, initially as prophylaxis for venous thromboembolism (VTE) in the orthopedic surgical setting. Future therapeutic directions for selective factor Xa inhibition in the management of other thrombotic diseases are discussed. Thromboembolic diseases can occur in the venous or arterial sides of the circulatory system. Factor Xa inhibition is a targeted approach to anticoagulation that resulted from significant advances in our understanding of the coagulation cascade. The factor Xa inhibitor fondaparinux has been studied extensively in the orthopedic surgical setting for the prophylaxis of VTE. Current investigations that are under way or completed evaluate the efficacy and safety of fondaparinux for the management of various thrombotic diseases. The future development of fondaparinux resides primarily in three therapeutic areas: prevention of VTE, treatment of VTE, and treatment of acute coronary syndromes. For the prevention of VTE, fondaparinux has been studied as extended prophylaxis following hip fracture surgery (PENTHIFRA Plus), for use in high-risk abdominal surgical patients (PEGASUS and APOLLO), and for use in medical patients (ARTEMIS). Studies evaluating fondaparinux for the treatment of VTE are part of the large MATISSE clinical program (MATISSE DVT and MATISSE PE). Fondaparinux was investigated in phase 2 studies for the treatment of acute coronary syndromes, including acute ST-segment myocardial infarction (PENTALYSE) and unstable angina (PENTUA). Encouraging data from these trials are the basis for phase 3 programs in this area (MICHELANGELO). The orthopedic prophylactic and nonorthopedic clinical programs for fondaparinux in the management of thrombosis support the concept that targeted inhibition of coagulation is an effective advance in antithrombotic therapy.

Economic analysis of the first 20 years of universal hepatitis B vaccination program in Italy: an a posteriori evaluation and forecast of future benefits.

PubMed

Boccalini, Sara; Taddei, Cristina; Ceccherini, Vega; Bechini, Angela; Levi, Miriam; Bartolozzi, Dario; Bonanni, Paolo

2013-05-01

Italy was one of the first countries in the world to introduce a routine vaccination program against HBV for newborns and 12-y-old children. From a clinical point of view, such strategy was clearly successful. The objective of our study was to verify whether, at 20 y from its implementation, hepatitis B universal vaccination had positive effects also from an economic point of view. An a posteriori analysis evaluated the impact that the hepatitis B immunization program had up to the present day. The implementation of vaccination brought an extensive reduction of the burden of hepatitis B-related diseases in the Italian population. As a consequence, the past and future savings due to clinical costs avoided are particularly high. We obtained a return on investment nearly equal to 1 from the National Health Service perspective, and a benefit-to-cost ratio slightly less than 1 for the Societal perspective, considering only the first 20 y from the start of the program. In the longer-time horizon, ROI and BCR values were positive (2.78 and 2.46, respectively). The break-even point was already achieved few years ago for the NHS and for the Society, and since then more and more money is progressively saved. The implementation of universal hepatitis B vaccination was very favorable during the first 20 y of adoption, and further benefits will be increasingly evident in the future. The hepatitis B vaccination program in Italy is a clear example of the great impact that universal immunization is able to provide in the medium-long-term when health care authorities are so wise as to invest in prevention.

The perceived value of clinical pharmacy service provision by pharmacists and physicians: an initial assessment of family medicine and internal medicine providers.

PubMed

Wietholter, Jon P; Ponte, Charles D; Long, Dustin M

2017-10-01

Few publications have addressed the perceptions of pharmacists and physicians regarding the value of clinical pharmacist services. A survey-based study was conducted to determine whether Internal Medicine (IM) and Family Medicine (FM) pharmacists and physicians differed in their attitudes regarding the benefits of collaboration in an acute care setting. The primary objective was to evaluate perceived differences regarding self-assessment of value between IM and FM pharmacists. The secondary objective was to evaluate perceived differences of clinical pharmacist benefit between IM and FM physicians. An eight-item questionnaire assessed the attitudes and beliefs of pharmacists and physicians regarding the value of clinical pharmacy services. Surveys were emailed and participants marked their responses using a 7-point Likert scale for each item. Demographic data and overall comments were collected from each participant. Overall, 167 surveys were completed. When comparing cumulative physician and pharmacist responses, none of the eight questions showed significant differences. Statistically significant differences were noted when comparing IM and FM clinical pharmacists on five of the eight survey items; for each of these items, FM pharmacists had more favourable perceptions than their IM counterparts. No statistically significant differences were noted when comparing responses of IM and FM physicians. This study found that FM pharmacists perceived a greater benefit regarding participation in inpatient acute care rounds when compared to their IM pharmacist counterparts. Future studies are necessary to determine if other medical specialties' perceptions of clinical pharmacy provision differ from our findings and to evaluate the rationale behind specific attitudes and behaviours. © 2016 Royal Pharmaceutical Society.

Introduction to the special issue on the personality assessment inventory.

PubMed

Kurtz, John E; Blais, Mark A

2007-02-01

This special issue of the Journal of Personality Assessment brings together 13 new research studies on the Personality Assessment Inventory (PAI; Morey, 1991) that should inform users and stimulate future empirical activity with this measure. In 4 articles, authors evaluate the validity scales and indexes of the PAI using both analog and criterion designs and samples from a variety of clinical and forensic settings. In a 5th article, the authors describe a novel approach to profile interpretation using two PAI negative distortion measures. The authors present applications of the PAI to new populations and problems including a German translation of the PAI and profile information for male batterers and victims of head injury. The authors of 2 studies extend research on the validity of the PAI for the assessment of borderline personality disorder. In the final 3 studies, the authors evaluate the validity of PAI measures of violence and aggression to predict subsequent aggressive behavior and institutional misconduct. Finally, the authors offer several suggestions for future research with the PAI.

Targeting the DNA damage response in oncology: past, present and future perspectives.

PubMed

Basu, Bristi; Yap, Timothy A; Molife, L Rhoda; de Bono, Johann S

2012-05-01

The success of poly(ADP-ribose) polymerase inhibition in BRCA1 or BRCA2 deficient tumors as an anticancer strategy provided proof-of-concept for a synthetic lethality approach in oncology. There is therefore now active interest in expanding this approach to include other agents targeting the DNA damage response (DDR). We review lessons learnt from the development of inhibitors against DNA damage response mechanisms and envision the future of DNA repair inhibition in oncology. Preclinical synthetic lethality screens may potentially identify the best combinations of DNA-damaging drugs with inhibitors of DNA repair and the DDR or two agents acting within the DDR. Efforts are currently being made to establish robust and cost-effective assays that may be implemented within appropriate time-scales in parallel with future clinical studies. Detection of relevant mutations in a high-throughput manner, such as with next-generation sequencing for genes implicated in homologous recombination, including BRCA1, BRCA2, and ataxia telangiectasia mutated is anticipated. Novel approaches targeting the DDR are currently being evaluated and inhibitors of ATM, RAD51 and DNA-dependent protein kinase are now in early drug discovery and development. There remains great enthusiasm in oncology practice for pursuing the strategy of synthetic lethality. The future development of antitumor agents targeting the DDR should include detailed correlative biomarker work within early phase clinical studies wherever possible, with clear attempts to identify doses at which robust target modulation is observed.

A critical assessment of boron target compounds for boron neutron capture therapy.

PubMed

Hawthorne, M Frederick; Lee, Mark W

2003-01-01

Boron neutron capture therapy (BNCT) has undergone dramatic developments since its inception by Locher in 1936 and the development of nuclear energy during World War II. The ensuing Cold War spawned the entirely new field of polyhedral borane chemistry, rapid advances in nuclear reactor technology and a corresponding increase in the number to reactors potentially available for BNCT. This effort has been largely oriented toward the eradication of glioblastoma multiforme (GBM) and melanoma with reduced interest in other types of malignancies. The design and synthesis of boron-10 target compounds needed for BNCT was not channeled to those types of compounds specifically required for GBM or melanoma. Consequently, a number of potentially useful boron agents are known which have not been biologically evaluated beyond a cursory examination and only three boron-10 enriched target species are approved for human use following their Investigational New Drug classification by the US Food and Drug Administration; BSH, BPA and GB-10. All ongoing clinical trials with GBM and melanoma are necessarily conducted with one of these three species and most often with BPA. The further development of BNCT is presently stalled by the absence of strong support for advanced compound evaluation and compound discovery driven by recent advances in biology and chemistry. A rigorous demonstration of BNCT efficacy surpassing that of currently available protocols has yet to be achieved. This article discusses the past history of compound development, contemporary problems such as compound classification and those problems which impede future advances. The latter include means for biological evaluation of new (and existing) boron target candidates at all stages of their development and the large-scale synthesis of boron target species for clinical trials and beyond. The future of BNCT is bright if latitude is given to the choice of clinical disease to be treated and if a recognized study demonstrating improved efficacy is completed. Eventually, BNCT in some form will be commercialized.

Patient-provider communications in outpatient clinic settings: a clinic-based evaluation of mobile device and multimedia mediated communications for patient education.

PubMed

Schooley, Benjamin; San Nicolas-Rocca, Tonia; Burkhard, Richard

2015-01-12

Many studies have provided evidence of the importance of quality provider-patient communications and have suggested improvements to patient understanding by using video-based instruction. The objective of this study was to understand how mobile information technology assisted video and three-dimensional (3D) image instruction, provided by a health care worker, influences two categories of outcome: (1) patient understanding of information about their condition and detailed medical discharge instructions; and (2) patient perceptions and attitudes toward their health care providers, which included physicians, nurses, and staff. We hypothesize that video and 3D image instruction, provided on a mobile, tablet hardware platform, will improve patient understanding about the diagnostic testing, diagnoses, procedures, medications, and health topics provided to them. We also propose that use of the tablet/video combination will result in improved attitudinal evaluation by patients of their providers and the treatment plan. This study evaluated a hospital clinic-based trial (patient N=284) of video and 3D image instruction, provided on a mobile, tablet hardware platform, and its potential to improve patient understanding about the diagnostic testing, diagnoses, procedures, medications, and health topics provided to them. Results showed strong evidence that the system was perceived as helpful for improving patient understanding, and that it improved communication between physicians and patients (P<.001). The advanced age of some patients had no effect on their perceptions of the tablet-based mediation. Physician comments provided useful insights on effective use of such systems in the future. Implications for further development and future research are discussed. This study added to the body of evidence that computer-assisted video instructional systems for patients can improve patient understanding of medical instructions from their health care providers and assist with patient compliance. In addition, such systems can be appealing to both patient and provider.

Patient-Provider Communications in Outpatient Clinic Settings: A Clinic-Based Evaluation of Mobile Device and Multimedia Mediated Communications for Patient Education

PubMed Central

Schooley, Benjamin; San Nicolas-Rocca, Tonia

2015-01-01

Background Many studies have provided evidence of the importance of quality provider-patient communications and have suggested improvements to patient understanding by using video-based instruction. Objective The objective of this study was to understand how mobile information technology assisted video and three-dimensional (3D) image instruction, provided by a health care worker, influences two categories of outcome: (1) patient understanding of information about their condition and detailed medical discharge instructions; and (2) patient perceptions and attitudes toward their health care providers, which included physicians, nurses, and staff. We hypothesize that video and 3D image instruction, provided on a mobile, tablet hardware platform, will improve patient understanding about the diagnostic testing, diagnoses, procedures, medications, and health topics provided to them. We also propose that use of the tablet/video combination will result in improved attitudinal evaluation by patients of their providers and the treatment plan. Methods This study evaluated a hospital clinic-based trial (patient N=284) of video and 3D image instruction, provided on a mobile, tablet hardware platform, and its potential to improve patient understanding about the diagnostic testing, diagnoses, procedures, medications, and health topics provided to them. Results Results showed strong evidence that the system was perceived as helpful for improving patient understanding, and that it improved communication between physicians and patients (P<.001). The advanced age of some patients had no effect on their perceptions of the tablet-based mediation. Physician comments provided useful insights on effective use of such systems in the future. Implications for further development and future research are discussed. Conclusions This study added to the body of evidence that computer-assisted video instructional systems for patients can improve patient understanding of medical instructions from their health care providers and assist with patient compliance. In addition, such systems can be appealing to both patient and provider. PMID:25583145

Modulation of hepcidin to treat iron deregulation: potential clinical applications

PubMed Central

Blanchette, Nicole L.; Manz, David H.; Torti, Frank M.

2016-01-01

The secreted peptide hormone hepcidin regulates systemic and local iron homeostasis through degradation of the iron exporter ferroportin. Dysregulation of hepcidin leads to altered iron homeostasis and development of pathological disorders including hemochromatosis, and iron loading and iron restrictive anemias. Therapeutic modulation of hepcidin is a promising method to ameliorate these conditions. Several approaches have been taken to enhance or reduce the effects of hepcidin in vitro and in vivo. Based on these approaches, hepcidin modulating drugs have been developed and are undergoing clinical evaluation. In this article we review the rationale for development of these drugs, the data concerning their safety and efficacy, their therapeutic uses, and potential future prospects. PMID:26669208

Female arsonists: key features, psychopathologies, and treatment needs.

PubMed

Gannon, Theresa A

2010-01-01

Female-perpetrated arson is a topic that has received relatively little research attention from either psychiatrists or psychologists. In this review, available research regarding the characteristics, psychopathologies, and current treatment efforts with female arsonists is reviewed. Evaluation of current research with female arsonists suggests that very few researchers have compared female arsonists either to suitable female offender control groups or male arsons. Consequently, clinical knowledge and practice regarding female-perpetrated arson is underdeveloped relative to both other areas of forensic-clinical psychiatry and to knowledge of male arsonists. Suggestions are made for translating current research into arson interventions with female arsonists. Core arenas for future treatment and research provision are also highlighted.

A combined group treatment for nightmares and insomnia in combat veterans: a pilot study.

PubMed

Swanson, Leslie M; Favorite, Todd K; Horin, Elizabeth; Arnedt, J Todd

2009-12-01

Insomnia and nightmares are hallmarks of posttraumatic stress disorder (PTSD). Sleep disturbances in PTSD negatively impact clinical course and functioning. In this open clinical trial, the preliminary effects of a combined treatment for insomnia and nightmares in combat veterans with PTSD were assessed. Ten combat veterans participated in a 10-session group treatment combining cognitive-behavioral therapy for insomnia with exposure, rescripting, and relaxation therapy. Participants maintained daily sleep and dream diaries and completed self-report measures of sleep quality and PTSD symptoms pre- and posttreatment. Participants reported improvements in sleep and nightmares following treatment. Future research using controlled designs to evaluate this treatment is warranted.

Ultrasound in the Diagnosis & Management of Pleural Effusions

PubMed Central

Soni, Nilam J.; Franco, Ricardo; Velez, Maria I.; Schnobrich, Daniel; Dancel, Ria; Restrepo, Marcos I.; Mayo, Paul H.

2015-01-01

We review the literature on the use of point-of-care ultrasound to evaluate and manage pleural effusions. Point-of-care ultrasound is more sensitive than physical exam and chest radiography to detect and characterize pleural fluid, and avoids many negative aspects of computerized tomography (CT). Additionally, point-of-care ultrasound can be used to assess pleural fluid volume and character, revealing possible underlying pathologies and guiding management. Thoracentesis performed with ultrasound guidance has lower risk of pneumothorax and bleeding complications. Future research should focus on the clinical-effectiveness of point-of-care ultrasound in the routine management of pleural effusions and how new technologies may expand its clinical utility. PMID:26218493

Confocal laser endomicroscopy in the "in vivo" histological diagnosis of the gastrointestinal tract.

PubMed

De Palma, Giovanni D

2009-12-14

Recent technological advances in miniaturization have allowed for a confocal scanning microscope to be integrated into a conventional flexible endoscope, or into trans-endoscopic probes, a technique now known as confocal endomicroscopy or confocal laser endomicroscopy. This newly-developed technology has enabled endoscopists to collect real-time in vivo histological images or "virtual biopsies" of the gastrointestinal mucosa during endoscopy, and has stimulated significant interest in the application of this technique in clinical gastroenterology. This review aims to evaluate the current data on the technical aspects and the utility of this new technology in clinical gastroenterology and its potential impact in the future, particularly in the screening or surveillance of gastrointestinal neoplasia.

Replication Study of the Milwaukee Inventory for Subtypes of Trichotillomania–Adult Version in a Clinically Characterized Sample

PubMed Central

Keuthen, Nancy J.; Tung, Esther S.; Woods, Douglas W.; Franklin, Martin E.; Altenburger, Erin M.; Pauls, David L.; Flessner, Christopher A.

2015-01-01

In the present study, we evaluated the Milwaukee Inventory for Subtypes of Trichotillomania–Adult Version (MIST-A) in a replication sample of clinically characterized hair pullers using exploratory factor analysis (EFA; N = 193). EFA eigenvalues and visual inspection of our scree plot revealed a two-factor solution. Factor structure coefficients and internal consistencies suggested a 13-item scale with an 8-item “Intention” scale and a 5-item “Emotion” scale. Both scales displayed good construct and discriminant validity. These findings indicate the need for a revised scale that provides a more refined assessment of pulling phenomenology that can facilitate future treatment advances. PMID:25868534

Antimycobacterial activity of pyrazinoate prodrugs in replicating and non-replicating Mycobacterium tuberculosis.

PubMed

Segretti, Natanael Dante; Simões, Cristina Kortstee; Corrêa, Michelle Fidelis; Felli, Veni Maria Andres; Miyata, Marcelo; Cho, Sang Hyun; Franzblau, Scott Gary; Fernandes, João Paulo Dos Santos

2016-07-01

Tuberculosis (TB) is an important infectious disease caused by Mycobacterium tuberculosis (Mtb) and responsible for thousands of deaths every year. Although there are antimycobacterial drugs available in therapeutics, just few new chemical entities have reached clinical trials, and in fact, since introduction of rifampin only two important drugs had reached the market. Pyrazinoic acid (POA), the active agent of pyrazinamide, has been explored through prodrug approach to achieve novel molecules with anti-Mtb activity, however, there is no activity evaluation of these molecules against non-replicating Mtb until the present. Additionally, pharmacokinetic must be preliminary evaluated to avoid future problems during clinical trials. In this paper, we have presented six POA esters as prodrugs in order to evaluate their anti-Mtb activity in replicating and non-replicating Mtb, and these showed activity highly influenced by medium composition (especially by albumin). Lipophilicity seems to play the main role in the activity, possibly due to controlling membrane passage. Novel duplicated prodrugs of POA were also described, presenting interesting activity. Cytotoxicity of these prodrugs set was also evaluated, and these showed no important cytotoxic profile. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluating impact of a multi-dimensional education programme on perceived performance of primary care professionals in diabetes care.

PubMed

Parekh, Sanjoti; Bush, Robert; Cook, Susan; Grant, Phillipa

2015-11-01

The purpose of this study is to evaluate an educational programme, 'Diabetes Connect: Connecting Professions', which was developed to enhance communication across primary care networks, to support best practice in clinical interventions and progress multidisciplinary team work to benefit patients in diabetes care. A total of 26 workshops were successfully delivered for 309 primary care professionals across the state of Queensland in Australia from November 2011. It consists of two separate, but complementary training elements: a series of online clinical education training modules and state-wide interprofessional learning workshops developed to enhance professional competencies. The evaluation design included completion of online surveys by the participants at two time points: first upon registering for the online modules or workshops; second, one week after attending a workshop. The survey included questions to evaluate the change in role performance measures. Overall, significant increases in participants' current knowledge, perceived ability to adopt this knowledge at work and willingness to change professional behaviour in the short term were observed. The study suggests that for maximum benefit both, workshop and online training, should be combined and made available widely. Future programmes should use a randomised trial design to test the delivery model.

Investigating Non-Invasive Hemodynamic Monitoring Devices Using Severe Dengue as a Surrogate for Trauma-Induced Shock

DTIC Science & Technology

2014-12-01

dengue hemorrhagic fever. In future work we will continue to evaluate the use of pulse wave forms to predict shock and will assess other...Index Three laboratory Phase I clinical trials have been completed to support a 510(k) application for FDA approval of the first prototype Pulse ... Oximeter with the CRI algorithm and capability for real-time continuous collection of photoplethymographic (PPG) analog signals. An FDA-cleared

Self-forgiveness in anorexia nervosa and bulimia nervosa.

PubMed

Watson, Michelle J; Lydecker, Janet A; Jobe, Rebecca L; Enright, Robert D; Gartner, Aubrey; Mazzeo, Suzanne E; Worthington, Everett L

2012-01-01

This study investigated whether low levels of self-forgiveness were associated with eating disorder symptomatology. Participating women (N = 51) had diagnoses of anorexia nervosa, bulimia nervosa, or no eating disorder diagnosis. They completed 3 measures of self-forgiveness. Women with eating disorders had lower levels of self-forgiveness compared with control participants. Results suggest that incorporating self-forgiveness interventions into current eating disorder treatments should be evaluated in future research as they might enhance clinical outcomes.

Envisioning a Future Contemplative Science of Mindfulness: Fruitful Methods and New Content for the Next Wave of Research

PubMed Central

Garland, Eric; Gaylord, Susan

2010-01-01

Mindfulness is an ancient spiritual practice as well as a unique behavioral technique involving the cultivation of non-judgmental, non-reactive, metacognitive awareness of present-moment experience. Given the growing interest in mindfulness across numerous academic and clinical disciplines, an agenda is needed to guide the next wave of research. Here, we suggest four areas that, in our view, are important for a future contemplative science of mindfulness: performance-based measures of mindfulness, scientific evaluation of Buddhist claims, neurophenomenology of mindfulness, and measuring changes in mindfulness-induced gene expression. By exploring these domains, the wisdom of the meditative traditions may be complemented by leading-edge empirical research methodologies. PMID:20671798

Is the Movement Assessment Battery for Children-2nd edition a reliable instrument to measure motor performance in 3 year old children?

PubMed

Smits-Engelsman, Bouwien C M; Niemeijer, Anuschka S; van Waelvelde, Hilde

2011-01-01

Formal testing of 3 year old children is a new feature in the revised version of the Movement Assessment Battery for Children (Movement ABC-2). Our study evaluated the reliability and explored the clinical applicability of the Movement ABC-2 Test in this young age group. A total of 50 typically children were given two trials of the test within a one to two week interval by two physical therapists: same assessor (n=28 children) and different assessors (n=22 children). Psychometric properties were evaluated by calculating internal consistency (Cronbach α), intra-class correlation (ICC), the standard error of measurement (SEM), the smallest detectable difference (SDD) and Kappa values for classification agreement. The results are promising for future implementation of the Movement ABC-2 in clinical practice. The children's performance was highly reproducible when tested by the same assessor (ICC .94) The SEM was 1.7 or 2.1 standard scores for 90% or 95% confidence intervals respectively, making the test sensitive enough to detect individual changes. If two different assessors tested the children the ICC was .76. In conclusion, the revised test can be applied to assess motor performance in typically developing 3-year old children. Future studies are needed to confirm if the same can be said for children with motor delays. Copyright © 2011 Elsevier Ltd. All rights reserved.

A new method for cryopreserving adipose-derived stem cells: an attractive and suitable large-scale and long-term cell banking technology.

PubMed

De Rosa, Alfredo; De Francesco, Francesco; Tirino, Virginia; Ferraro, Giuseppe A; Desiderio, Vincenzo; Paino, Francesca; Pirozzi, Giuseppe; D'Andrea, Francesco; Papaccio, Gianpaolo

2009-12-01

Recent studies have shown potential ways for improving stem cell cryopreservation. The major need for autologous stem cell use is a long-term storage: this arises from the humans' hope of future use of their own cells. Therefore, it is important to evaluate the cell potential of vitality and differentiation before and after cryopreservation. Although several studies have shown a long-term preservation of adipose tissue, a few of them focused their attention to stem cells. The aim of this study was to evaluate the fate of cryopreserved stem cells collected from adipose tissue and stored at low a temperature in liquid nitrogen through an optimal cryopreservation solution (using slowly cooling in 6% threalose, 4% dimethyl sulfoxide, and 10% fetal bovine serum) and to develop a novel approach to efficiently preserve adipose-derived stem cells (ASCs) for future clinical applications. Results showed that stem cells, after being thawed, are still capable of differentiation and express all surface antigens detected before storage, confirming the integrity of their biology. In particular, ASCs differentiated into adipocytes, showed diffuse positivity for PPARgamma and adiponectin, and were also able to differentiate into endothelial cells without addition of angiogenic factors. Therefore, ASCs can be long-term cryopreserved, and this, due to their great numbers, is an attractive tool for clinical applications as well as of impact for the derived market.

Books and reading: evidence-based standard of care whose time has come.

PubMed

Zuckerman, Barry; Augustyn, Marilyn

2011-01-01

Reach Out and Read (ROR) is the only systematically evaluated clinical activity to promote child development in primary care used throughout the United States. The ROR intervention is straightforward: clinicians provide advice about the benefits of reading aloud, as well as directly giving books to high-risk children and parents to take home at each pediatric visit of children aged 6 months to 5 years. ROR builds upon a significant evidence base of the value of reading aloud to young children. The studies evaluating ROR from different sites from subjects from different racial backgrounds and numerous outcome measures are consistently positive. From its initial single site at Boston City Hospital in 1989, to over 4600 clinical sites in 2010, over 30 000 clinicians distributed over 6.2 million books a year to 3.9 million children across the United States. The future efforts for ROR include integrating mental health competencies found in American Academy of Pediatrics guidelines as part of residency and clinician training into the ROR paradigm, quality improvement to ensure fidelity to the intervention, and expanded pediatric clinician involvement in local early childhood/school readiness community efforts. Finally, the most important future goal is the adoption of giving advice about reading aloud and giving developmentally appropriate books to high-risk families as best practice by official bodies. Copyright © 2011 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

SU-F-T-433: Evaluation of a New Dose Mimicking Application for Clinical Flexibility and Reliability

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

Hoffman, D; Nair, C Kumaran; Wright, C

2016-06-15

Purpose: Clinical workflow and machine down time occasionally require patients to be temporarily treated on a system other than the initial treatment machine. A new commercial dose mimicking application provides automated cross-platform treatment planning to expedite this clinical flexibility. The aim of this work is to evaluate the feasibility of automatic plan creation and establish a robust clinical workflow for prostate and pelvis patients. Methods: Five prostate and five pelvis patients treated with helical plans were selected for re-planning with the dose mimicking application, covering both simple and complex scenarios. Two-arc VMAT and 7- and 9-field IMRT plans were generatedmore » for each case, with the objective function of achieving similar dose volume histogram from the initial helical plans. Dosimetric comparisons include target volumes and organs at risk (OARs) (rectum, bladder, small bowel, femoral heads, etc.). Dose mimicked plans were evaluated by a radiation oncologist, and patient-specific QAs were performed to validate delivery. Results: Overall plan generation and transfer required around 30 minutes of dosimetrist’s time once the dose-mimicking protocol is setup for each site. The resulting VMAT and 7- and 9-field IMRT plans achieved equivalent PTV coverage and homogeneity (D99/DRx = 97.3%, 97.2%, 97.2% and HI = 6.0, 5.8, and 5.9, respectively), compared to helical plans (97.6% and 4.6). The OAR dose discrepancies were up to 6% in rectum Dmean, but generally lower in bladder, femoral heads, bowel and penile bulb. In the context of 1–5 fractions, the radiation oncologist evaluated the dosimetric changes as not clinically significant. All delivery QAs achieved >90% pass with a 3%/3mm gamma criteria. Conclusion: The automated dose-mimicking workflow offers a strategy to avoid missing treatment fractions due to machine down time with non-clinically significant changes in dosimetry. Future work will further optimize dose mimicking plans and investigate other cross-platform treatment delivery options.« less

A Systematic Review and Appraisal of Clinical Practice Guidelines for Musculoskeletal Soft Tissue Injuries and Conditions.

PubMed

Pincus, Daniel; Kuhn, John E; Sheth, Ujash; Rizzone, Katie; Colbenson, Kristi; Dwyer, Tim; Karpinos, Ashley; Marks, Paul H; Wasserstein, David

2017-05-01

Clinical practice guidelines (CPGs) are published by several sports medicine institutions. A systematic evaluation can help identify the highest quality CPGs for clinical use and identify any deficiencies that remain. To identify and appraise CPGs relevant to clinical sports medicine professionals. Systematic review. Predetermined selection criteria were utilized by 2 reviewers who independently identified published CPGs before January 1, 2014. CPGs were excluded if they focused on injured workers, radiological criteria, medical pathology, or the axial skeleton (back/neck). The remaining guidelines were scored by 6 reviewers with different clinical backgrounds using the Appraisal of Guidelines for Research and Evaluation II (AGREE II). Scores lower than 50% indicated deficiency. Scores were also stratified by the publishing institution and anatomic location and compared using Kruskal-Wallis tests. The Spearman correlation coefficient was used to assess the range of interobserver agreement between the evaluators. Seventeen CPGs met the inclusion criteria. The majority of guidelines pertained to the knee, ankle, or shoulder. Interobserver agreement was strong ( r = 0.548-0.740), and mean total scores between nonsurgical (107.8) and surgical evaluators (109.3) were not statistically different. Overall guideline quality was variable but not deficient for 16 of 17 guidelines (>50%), except regarding clinical "applicability" and "editorial independence." No difference was found between CPGs of the knee, shoulder, foot/ankle, or chronic conditions. However, CPG publishing institutions had significantly different scores; the American Academy of Orthopaedic Surgeons (AAOS) guidelines scored significantly higher (141.4) than the total mean score (108.0). The overall quality of sports medicine CPGs was variable but generally not deficient, except regarding applicability and editorial independence. Bias through poor editorial independence is a concern. To improve future guideline quality, authors should pay particular attention to these areas and use existing highest quality guidelines, or the AGREE II instrument, as templates. CPGs dedicated to anatomic areas other than the knee, ankle, and shoulder are needed.

Evaluation of Frailty in Older Adults With Cardiovascular Disease

PubMed Central

Gary, Rebecca

2013-01-01

Rapid growth in the numbers of older adults with cardiovascular disease (CVD) is raising awareness and concern of the impact that common geriatric syndromes such as frailty may have on clinical outcomes, health-related quality of life, and rising economic burden associated with healthcare. Increasingly, frailty is recognized to be a highly prevalent and important risk factor that is associated with adverse cardiovascular outcomes. A limitation of previous studies in patients with CVD has been the lack of a consistent definition and measures to evaluate frailty. In this review, building upon the work of Fried and colleagues, a definition of frailty is provided that is applicable for evaluating frailty in older adults with CVD. Simple, well-established performance-based measures widely used in comprehensive geriatric assessment are recommended that can be readily implemented by nurses in most practice settings. The limited studies conducted in older adults with CVD have shown physical performance measures to be highly predictive of clinical outcomes. Implications for practice and areas for future research are described for the growing numbers of elderly cardiac patients who are frail frailty and at risk for disability. PMID:22334147

HbA1c for diagnosis and prognosis of gestational diabetes mellitus.

PubMed

Kwon, Soon Sung; Kwon, Ja-Young; Park, Yong-Won; Kim, Young-Han; Lim, Jong-Baeck

2015-10-01

HbA1c is a widely used marker in diagnosing type 2 diabetes mellitus (DM), but its clinical utility in diagnosing gestational diabetes mellitus (GDM) is not established. Here, we evaluated the clinical usefulness of HbA1c in diagnosing GDM and predicting the risk of future type 2 DM development among GDM patients. This retrospective, cross-sectional study included 321 subjects who underwent 100-g oral glucose tolerance tests (OGTT) during pregnancy. HbA1c and other variables were analyzed to evaluate their diagnostic performance for GDM. To evaluate the clinical usefulness of HbA1c in predicting future type 2 DM development, we classified GDM subjects who had more than 3 months of follow-up data into two subgroups: those who developed postpartum type 2 DM (PDM) and those who did not. HbA1c was significantly higher in the GDM group than in the normal control group. With the 100-g OGTT as reference, HbA1c showed 91.3% sensitivity and 62% specificity at a cut-off value of 5.05% (32 mmol/mol) for GDM diagnosis. At a cut-off value of 5.25% (34 mmol/mol), sensitivity was 73.6% and specificity was 77.2%. HbA1c levels during pregnancy were higher in those with PDM than in those without PDM (5.91 [41 mmol/mol] vs. 5.44% [36 mmol/mol], p<0.001). The prognostic value of HbA1c for PDM was evaluated by ROC curve analysis, with sensitivity of 78.6% and specificity of 72.5% at a cut-off value of 5.55% (37 mmol/mol). HbA1c showed high sensitivity with relatively low specificity for diagnosis of GDM in pregnant women and was a potential predictor of PDM. HbA1c may be able to be used as a simple and less invasive alternative screening test for OGTT in GDM patients. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Progression of Ebola Therapeutics During the 2014-2015 Outbreak.

PubMed

Mendoza, Emelissa J; Qiu, Xiangguo; Kobinger, Gary P

2016-02-01

The recent Ebola virus (EBOV) outbreak in West Africa was the deadliest EBOV epidemic in history, highlighting the need for a safe and efficacious treatment against EBOV disease (EVD). In the absence of an approved treatment, experimental drugs were utilized under compassionate grounds hoping to diminish EVD-associated morbidity and mortality. As more data were collected from safety studies, Phase II/III clinical trials were introduced in Guinea, Sierra Leone, and Liberia to test promising candidates, including small-molecule drugs, RNA-based treatments, and antibody-based therapies. In this review, we summarize the use of, and preliminary observations from, current clinical trials with EVD therapeutics, shedding light on experimental drug selection, emergency clinical evaluation, and the impact these factors may have on future infectious disease outbreaks. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Imaging: Guiding the Clinical Translation of Cardiac Stem Cell Therapy

PubMed Central

Nguyen, Patricia K.; Lan, Feng; Wang, Yongming; Wu, Joseph C.

2011-01-01

Stem cells have been touted as the holy grail of medical therapy with promises to regenerate cardiac tissue, but it appears the jury is still out on this novel therapy. Using advanced imaging technology, scientists have discovered that these cells do not survive nor engraft long-term. In addition, only marginal benefit has been observed in large animal studies and human trials. However, all is not lost. Further application of advanced imaging technology will help scientists unravel the mysteries of stem cell therapy and address the clinical hurdles facing its routine implementation. In this review, we will discuss how advanced imaging technology will help investigators better define the optimal delivery method, improve survival and engraftment, and evaluate efficacy and safety. Insights gained from this review may direct the development of future preclinical investigations and clinical trials. PMID:21960727

Clinical studies in restorative dentistry: New directions and new demands.

PubMed

Opdam, N J M; Collares, K; Hickel, R; Bayne, S C; Loomans, B A; Cenci, M S; Lynch, C D; Correa, M B; Demarco, F; Schwendicke, F; Wilson, N H F

2018-01-01

Clinical research of restorative materials is confounded by problems of study designs, length of trials, type of information collected, and costs for trials, despite increasing numbers and considerable development of trials during the past 50 years. This opinion paper aims to discuss advantages and disadvantages of different study designs and outcomes for evaluating survival of dental restorations and to make recommendations for future study designs. Advantages and disadvantages of randomized trials, prospective and retrospective longitudinal studies, practice-based, pragmatic and cohort studies are addressed and discussed. The recommendations of the paper are that clinical trials should have rational control groups, include confounders such as patient risk factors in the data and analysis and should use outcome parameters relevant for profession and patients. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Recent developments of cyclotron produced radionuclides for nuclear cardiology

NASA Astrophysics Data System (ADS)

Kulkarni, P. V.; Jansen, D. E.; Corbett, J. R.

1987-04-01

For over a decade myocardial perfusion imaging with thallium-201, a cyclotron product, has been routinely used in clinical medicine. Recent advances have allowed the efficient production of very high purity (> 99.8%) iodine-123. New metabolically active 123I labeled radiopharmaceuticals, including alkyl and phenyl fatty acids, and norepinephrine analogs, have been developed and are undergoing clinical trials. Fab' fragments of monoclonal antibodies to cardiac myosin have been labeled with indium-111 ( 111In) and are undergoing clinical evaluation for imaging myocardial infarcts. Monoclonal antibodies to platelets, fibrin, and the thrombolytic agent, tissue plasminogen activator (TPA), have recently been labeled with 111In. Together these developments in radiotracers and instrumentation should have a significant impact on the future of cardiovascular nuclear medicine. This manuscript will discuss developments in single photon emitting radiotracers for myocardial imaging.

An update on safety and immunogenicity of vaccines containing emulsion-based adjuvants.

PubMed

Fox, Christopher B; Haensler, Jean

2013-07-01

With the exception of alum, emulsion-based vaccine adjuvants have been administered to far more people than any other adjuvant, especially since the 2009 H1N1 influenza pandemic. The number of clinical safety and immunogenicity evaluations of vaccines containing emulsion adjuvants has correspondingly mushroomed. In this review, the authors introduce emulsion adjuvant composition and history before detailing the most recent findings from clinical and postmarketing data regarding the effects of emulsion adjuvants on vaccine immunogenicity and safety, with emphasis on the most widely distributed emulsion adjuvants, MF59® and AS03. The authors also present a summary of other emulsion adjuvants in clinical development and indicate promising avenues for future emulsion-based adjuvant development. Overall, emulsion adjuvants have demonstrated potent adjuvant activity across a number of disease indications along with acceptable safety profiles.

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.

Cannabinoids and Epilepsy.

PubMed

Rosenberg, Evan C; Tsien, Richard W; Whalley, Benjamin J; Devinsky, Orrin

2015-10-01

Cannabis has been used for centuries to treat seizures. Recent anecdotal reports, accumulating animal model data, and mechanistic insights have raised interest in cannabis-based antiepileptic therapies. In this study, we review current understanding of the endocannabinoid system, characterize the pro- and anticonvulsive effects of cannabinoids [e.g., Δ9-tetrahydrocannabinol and cannabidiol (CBD)], and highlight scientific evidence from pre-clinical and clinical trials of cannabinoids in epilepsy. These studies suggest that CBD avoids the psychoactive effects of the endocannabinoid system to provide a well-tolerated, promising therapeutic for the treatment of seizures, while whole-plant cannabis can both contribute to and reduce seizures. Finally, we discuss results from a new multicenter, open-label study using CBD in a population with treatment-resistant epilepsy. In all, we seek to evaluate our current understanding of cannabinoids in epilepsy and guide future basic science and clinical studies.

[Talks on evaluation of students' writing (discussion)].

PubMed

Terazawa, K; Otaki, J; Abe, K

2001-09-01

We talked about the evaluation of students' writing; this is thought to be difficult for teachers. We have a class "history of medicine" for freshmen in the second semester of the medical course. Students give lecture by themselves on famous historical persons in medicine such as Hippocrates, Vesalius, Pasteur and Sackett, referring to their historical significance in present medicine. As the final work of the subject they write report on "clinical medicine or medical researches 20 years in future and myself". We talked generally about educational evaluation in various aspects, concerning the methods for writing. We discussed mainly on two themes--ability to write and originality in thinking. We give a larger point to the originality, which correlates to ability to write, though we feel difficult in evaluating students' originality only by reading their reports. We also emphasize the importance of active interaction between students and teachers, and to evaluate educational activities of teachers in Japanese universities.

Case study of evaluations that go beyond clinical outcomes to assess quality improvement diabetes programmes using the Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE)

PubMed Central

Harris, Stewart B.; Naqshbandi Hayward, Mariam; Tompkins, Jordan W.

2016-01-01

Abstract Rationale, aims and objectives Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real‐world evaluation. Method Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real‐world comprehensive evaluations in health care settings. Results The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub‐steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built‐in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. Conclusions This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale‐up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. PMID:26804339

Pharmacological management of chronic lower back pain: a review of cost effectiveness.

PubMed

Haas, Marion; De Abreu Lourenco, Richard

2015-06-01

Lower back pain is one of the most prevalent musculoskeletal conditions in the developed world and accounts for significant health services use. The American College of Physicians and the American Pain Society have published a joint clinical guideline that recommends providing patients with information on prognosis and self-management, the use of medications with proven benefits and, for those who do not improve, consideration be given to the use of spinal manipulation (for acute lower back pain only), interdisciplinary rehabilitation, exercise, acupuncture, massage, yoga, cognitive behavioural therapy or relaxation. The purpose of this review was to evaluate published economic evaluations of pharmacological management for chronic lower back pain. A total of seven studies were eligible for inclusion in there view. The quality of the economic evaluations undertaken in the included studies was not high. This was primarily because of the nature of the underlying clinical evidence, most of which did not come from rigorous randomised controlled trials (RCTs), and the manner in which it was incorporated into the economic evaluations. All studies provided reasonable information about what aspects of healthcare and other resource use were identified, measured and valued. However, the reporting of total costs was not uniform across studies. Measures of pain and disability were the most commonly collected outcomes measures. Two studies collected information on quality of life directly from participants while two studies modelled this information based on the literature. Future economic evaluations of interventions for chronic lower back pain, including pharmacological interventions, should be based on the results of well-conducted RCTs where the measurement of costs and outcomes such as quality of life and quality-adjusted life-years is included in the trial protocol, and which have a follow-up period sufficient to capture meaningful changes in both costs and outcomes. In the absence of RCT data, economic models should be used to estimate future costs and outcomes using robust methods.

Reproducibility of clinical research in critical care: a scoping review.

PubMed

Niven, Daniel J; McCormick, T Jared; Straus, Sharon E; Hemmelgarn, Brenda R; Jeffs, Lianne; Barnes, Tavish R M; Stelfox, Henry T

2018-02-21

The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies. We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants. Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt. A minority of critical care practices with research published in high-profile journals were evaluated for reproducibility; less than half had reproducible effects.

Evaluating the effectiveness of clinical medical librarian programs: a systematic review of the literature*

PubMed Central

Wagner, Kay Cimpl; Byrd, Gary D.

2004-01-01

Objective: This study was undertaken to determine if a systematic review of the evidence from thirty years of literature evaluating clinical medical librarian (CML) programs could help clarify the effectiveness of this outreach service model. Methods: A descriptive review of the CML literature describes the general characteristics of these services as they have been implemented, primarily in teaching-hospital settings. Comprehensive searches for CML studies using quantitative or qualitative evaluation methods were conducted in the medical, allied health, librarianship, and social sciences literature. Findings: Thirty-five studies published between 1974 and 2001 met the review criteria. Most (30) evaluated single, active programs and used descriptive research methods (e.g., use statistics or surveys/questionnaires). A weighted average of 89% of users in twelve studies found CML services useful and of high quality, and 65% of users in another overlapping, but not identical, twelve studies said these services contributed to improved patient care. Conclusions: The total amount of research evidence for CML program effectiveness is not great and most of it is descriptive rather than comparative or analytically qualitative. Standards are needed to consistently evaluate CML or informationist programs in the future. A carefully structured multiprogram study including three to five of the best current programs is needed to define the true value of these services. PMID:14762460

Evaluation in undergraduate medical education: Conceptualizing and validating a novel questionnaire for assessing the quality of bedside teaching.

PubMed

Dreiling, Katharina; Montano, Diego; Poinstingl, Herbert; Müller, Tjark; Schiekirka-Schwake, Sarah; Anders, Sven; von Steinbüchel, Nicole; Raupach, Tobias

2017-08-01

Evaluation is an integral part of curriculum development in medical education. Given the peculiarities of bedside teaching, specific evaluation tools for this instructional format are needed. Development of these tools should be informed by appropriate frameworks. The purpose of this study was to develop a specific evaluation tool for bedside teaching based on the Stanford Faculty Development Program's clinical teaching framework. Based on a literature review yielding 47 evaluation items, an 18-item questionnaire was compiled and subsequently completed by undergraduate medical students at two German universities. Reliability and validity were assessed in an exploratory full information item factor analysis (study one) and a confirmatory factor analysis as well as a measurement invariance analysis (study two). The exploratory analysis involving 824 students revealed a three-factor structure. Reliability estimates of the subscales were satisfactory (α = 0.71-0.84). The model yielded satisfactory fit indices in the confirmatory factor analysis involving 1043 students. The new questionnaire is short and yet based on a widely-used framework for clinical teaching. The analyses presented here indicate good reliability and validity of the instrument. Future research needs to investigate whether feedback generated from this tool helps to improve teaching quality and student learning outcome.

Screening for DSM-5 Other Specified Feeding or Eating Disorder in a Weight-Loss Treatment–Seeking Obese Sample

PubMed Central

Gorman, Mark J.; Sogg, Stephanie; Lamont, Evan M.; Eddy, Kamryn T.; Becker, Anne E.; Thomas, Jennifer J.

2014-01-01

Objective: To evaluate the effectiveness of specific self-report questionnaires in detecting DSM-5 eating disorders identified via structured clinical interview in a weight-loss treatment–seeking obese sample, to improve eating disorder recognition in general clinical settings. Method: Individuals were recruited over a 3-month period (November 2, 2011, to January 10, 2012) when initially presenting to a hospital-based weight-management center in the northeastern United States, which offers evaluation and treatment for outpatients who are overweight or obese. Participants (N = 100) completed the Structured Clinical Interview for DSM-IV eating disorder module, a DSM-5 feeding and eating disorders interview, and a battery of self-report questionnaires. Results: Self-reports and interviews agreed substantially in the identification of bulimia nervosa (DSM-IV and DSM-5: tau-b = 0.71, P < .001) and binge-eating disorder (DSM-IV and DSM-5: tau-b = 0.60, P < .001), modestly for subthreshold binge-eating disorder (tau-b = 0.44, P < .001), and poorly for other subthreshold conditions (night-eating syndrome: tau-b = –0.04, P = .72, r = 0.06 [DSM-5]). Discussion: Current self-report assessments are likely to identify full syndrome DSM-5 eating disorders in treatment-seeking obese samples, but unlikely to detect DSM-5 other specified feeding or eating disorders. We propose specific content changes that might enhance clinical utility as suggestions for future evaluation. PMID:25667810

Clinical applications of the functional connectome

PubMed Central

Castellanos, F. Xavier; Di Martino, Adriana; Craddock, R. Cameron; Mehta, Ashesh D.; Milham, Michael P.

2013-01-01

Central to the development of clinical applications of functional connectomics for neurology and psychiatry is the discovery and validation of biomarkers. Resting state fMRI (R-fMRI) is emerging as a mainstream approach for imaging-based biomarker identification, detecting variations in the functional connectome that can be attributed to clinical variables (e.g., diagnostic status). Despite growing enthusiasm, many challenges remain. Here, we assess evidence of the readiness of R-fMRI based functional connectomics to lead to clinically meaningful biomarker identification through the lens of the criteria used to evaluate clinical tests (i.e., validity, reliability, sensitivity, specificity, and applicability). We focus on current R-fMRI-based prediction efforts, and survey R-fMRI used for neurosurgical planning. We identify gaps and needs for R-fMRI-based biomarker identification, highlighting the potential of emerging conceptual, analytical and cultural innovations (e.g., the Research Domain Criteria Project (RDoC), open science initiatives, and Big Data) to address them. Additionally, we note the need to expand future efforts beyond identification of biomarkers for disease status alone to include clinical variables related to risk, expected treatment response and prognosis. PMID:23631991

Impact of clinical pharmacy services in a short stay unit of a hospital emergency department in Qatar.

PubMed

Abdelaziz, Hani; Al Anany, Rasha; Elmalik, Ashraf; Saad, Mohammad; Prabhu, Kirti; Al-Tamimi, Haleema; Salah, Salem Abu; Cameron, Peter

2016-08-01

Background The presence of a clinical pharmacist in a hospital's Emergency Department (ED) is important to decrease the potential for medication errors. To our knowledge, no previous studies have been conducted to evaluate the impact of implementing clinical pharmacy services in the ED in Qatar. Objective To characterize the contributions of clinical pharmacists in a short stay unit of ED in order to implement and scale-up the service to all ED areas in the future. Methods A retrospective study conducted for 7 months in the ED of Hamad General Hospital, Qatar. The intervention recommendations were made by clinical pharmacists to the physician in charge during medical rounds. Results A total of 824 documented pharmacist recommendations were analyzed. The interventions included the following: Providing information to the physician (24.4 %) and recommending medication discontinuation (22.0 %), dose adjustment (19.3 %), medication addition (16.0 %), changes in frequency of medications (7.6 %), medication resumption (5.7 %), and patient education (5.0 %). Conclusion Clinical pharmacists in the ED studied play an important role in patient care.

Molecular Dimensions of Gastric Cancer: Translational and Clinical Perspectives.

PubMed

Choi, Yoon Young; Noh, Sung Hoon; Cheong, Jae-Ho

2016-01-01

Gastric cancer is a global health burden and has the highest incidence in East Asia. This disease is complex in nature because it arises from multiple interactions of genetic, local environmental, and host factors, resulting in biological heterogeneity. This genetic intricacy converges on molecular characteristics reflecting the pathophysiology, tumor biology, and clinical outcome. Therefore, understanding the molecular characteristics at a genomic level is pivotal to improving the clinical care of patients with gastric cancer. A recent landmark study, The Cancer Genome Atlas (TCGA) project, showed the molecular landscape of gastric cancer through a comprehensive molecular evaluation of 295 primary gastric cancers. The proposed molecular classification divided gastric cancer into four subtypes: Epstein-Barr virus-positive, microsatellite unstable, genomic stable, and chromosomal instability. This information will be taken into account in future clinical trials and will be translated into clinical therapeutic decisions. To fully realize the clinical benefit, many challenges must be overcome. Rapid growth of high-throughput biology and functional validation of molecular targets will further deepen our knowledge of molecular dimensions of this cancer, allowing for personalized precision medicine.

Radiological input during paediatric multidisciplinary team meetings and its influence on clinical patient management.

PubMed

Llewellyn-Jones, Glyn; Pereira, John

2016-04-01

There is little information about the role of the radiologist at multidisciplinary team meetings; in particular their influence on patient management. To evaluate the influence of radiologists on clinical patient management during multidisciplinary meetings. Prospective data were collected over a 5-week period from multidisciplinary team meetings across four paediatric clinical domains. Radiological input was recorded for each case discussion, including the type of influence and its potential effect on clinical patient management. One hundred and forty paediatric cases were reviewed. Radiological advice was requested from the radiologist for 25.7% (N = 36) of cases. In 17.9% (N = 25) this advice was judged to have influenced clinical patient management. There were two cases where new imaging findings were discovered. Radiologists influence clinical patient management during multidisciplinary team meetings primarily by providing differential diagnoses and guidance regarding future imaging, with respect to both the necessity and the modality. Occasionally, when imaging is reviewed at these meetings, new findings are discovered that impact on patient management. © 2016 The Royal Australian and New Zealand College of Radiologists.

The Challenge of Targeting Notch in Hematologic Malignancies

PubMed Central

Hernandez Tejada, Fiorela N.; Galvez Silva, Jorge R.; Zweidler-McKay, Patrick A.

2014-01-01

Notch signaling can play oncogenic and tumor suppressor roles depending on cell type. Hematologic malignancies encompass a wide range of transformed cells, and consequently the roles of Notch are diverse in these diseases. For example Notch is a potent T-cell oncogene, with >50% of T-cell acute lymphoblastic leukemia (T-ALL) cases carry activating mutations in the Notch1 receptor. Targeting Notch signaling in T-ALL with gamma-secretase inhibitors, which prevent Notch receptor activation, has shown pre-clinical activity, and is under evaluation clinically. In contrast, Notch signaling inhibits acute myeloblastic leukemia growth and survival, and although targeting Notch signaling in AML with Notch activators appears to have pre-clinical activity, no Notch agonists are clinically available at this time. As such, despite accumulating evidence about the biology of Notch signaling in different hematologic cancers, which provide compelling clinical promise, we are only beginning to target this pathway clinically, either on or off. In this review, we will summarize the evidence for oncogenic and tumor suppressor roles of Notch in a wide range of leukemias and lymphomas, and describe therapeutic opportunities for now and the future. PMID:24959528

[Upon scientific accuracy scheme at clinical specialties].

PubMed

Ortega Calvo, M

2006-11-01

Will be medical specialties like sciences in the future? Yes, progressively they will. Accuracy in clinical specialties will be dissimilar in the future because formal-logic mathematics, quantum physics advances and relativity theory utilities. Evidence based medicine is now helping to clinical specialties on scientific accuracy by the way of decision theory.

Current evidence and future directions for research with omega-3 fatty acids and attention deficit hyperactivity disorder.

PubMed

Gow, Rachel V; Hibbeln, Joseph R; Parletta, Natalie

2015-03-01

Nutritional insufficiencies of nutrients such as omega-3 highly unsaturated fatty acids (HUFAs), vitamins and minerals have been linked to suboptimal developmental outcomes including attention deficit hyperactivity disorder (ADHD). Although the predominant treatment is currently psychostimulant medications, randomized clinical trials with omega-3 HUFAs have reported small-to-modest effects in reducing symptoms of ADHD in children despite arguable individual methodological and design misgivings. This review presents, discusses and critically evaluates data and findings from meta-analytic and systematic reviews and clinical trials published within the last 12 months. Recent trajectories of this research are discussed, such as comparing eicosapentaenoic acid and docosahexaenoic acid and testing the efficacy of omega-3 HUFAs as an adjunct to methylphenidate. Discussion includes highlighting limitations and potential future directions such as addressing variable findings by accounting for other nutritional deficiencies and behavioural food intolerances. The authors conclude that given the current economic burden of ADHD, estimated in the region of $77 billion in the USA alone, in addition to the fact that a proportion of patients with ADHD are either treatment resistant, nonresponders or withdraw from medication because of adverse side-effects, the investigation of nonpharmacological interventions including omega-3 HUFAs in clinical practice warrants extrapolating.

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.

Clinical Predictors of Severe Cetuximab-Induced Rash: Observations from 933 Patients Enrolled in North Central Cancer Treatment Group Study N0147

PubMed Central

Jatoi, Aminah; Green, Erin M.; Rowland, Jr., Kendrith M.; Sargent, Daniel J.; Alberts, Steven R.

2009-01-01

Objective Epidermal growth factor receptor inhibitors can result in a severe rash in 5–10% of patients and can detract from quality of life. The objective of this study was to identify clinical predictors of severe rash in the hope of utilizing such factors in the design of future rash palliative and prevention trials. Methods 933 cetuximab-treated patients enrolled on N0147, an adjuvant chemotherapy trial for colon cancer, were evaluated for clinical risk factors of severe rash. Results Within this cohort, 50 patients (5%) developed a severe rash (grade 3). More men compared to women developed such a rash: 34 (7%) versus 16 (3%) (multivariate odds ratio = 2.12; 95% confidence interval: 1.14–3.88; p = 0.017). A greater number of younger patients (<70 years of age) also developed a rash: 48 (6%) versus 2 (1%) (multivariate odds ratio = 0.21; 95% confidence interval: 0.05–0.88; p = 0.032). Race and performance score were not predictive. Conclusion Men and younger patients are at greater risk for a severe cetuximab-induced rash although overall the risk is low. These observations are particularly important in designing future rash prevention and palliation trials. PMID:19622902

Sensorimotor Training in Virtual Reality: A Review

PubMed Central

Adamovich, Sergei V.; Fluet, Gerard G.; Tunik, Eugene; Merians, Alma S.

2010-01-01

Recent experimental evidence suggests that rapid advancement of virtual reality (VR) technologies has great potential for the development of novel strategies for sensorimotor training in neurorehabilitation. We discuss what the adaptive and engaging virtual environments can provide for massive and intensive sensorimotor stimulation needed to induce brain reorganization. Second, discrepancies between the veridical and virtual feedback can be introduced in VR to facilitate activation of targeted brain networks, which in turn can potentially speed up the recovery process. Here we review the existing experimental evidence regarding the beneficial effects of training in virtual environments on the recovery of function in the areas of gait, upper extremity function and balance, in various patient populations. We also discuss possible mechanisms underlying these effects. We feel that future research in the area of virtual rehabilitation should follow several important paths. Imaging studies to evaluate the effects of sensory manipulation on brain activation patterns and the effect of various training parameters on long term changes in brain function are needed to guide future clinical inquiry. Larger clinical studies are also needed to establish the efficacy of sensorimotor rehabilitation using VR approaches in various clinical populations and most importantly, to identify VR training parameters that are associated with optimal transfer into real-world functional improvements. PMID:19713617

Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting.

PubMed

Bouça-Machado, Raquel; Rosário, Madalena; Alarcão, Joana; Correia-Guedes, Leonor; Abreu, Daisy; Ferreira, Joaquim J

2017-01-25

Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care. We performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool. We retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding. While the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.

Patient-reported outcomes and socioeconomic status as predictors of clinical outcomes following hematopoietic stem cell transplantation: A study from the BMT CTN 0902 trial

PubMed Central

Knight, Jennifer M; Syrjala, Karen L; Majhail, Navneet S; Martens, Michael; Le-Rademacher, Jennifer; Logan, Brent R; Lee, Stephanie J; Jacobsen, Paul B; Wood, William A; Jim, Heather SL; Wingard, John R; Horowitz, Mary M; Abidi, Muneer H; Fei, Mingwei; Rawls, Laura; Rizzo, J Douglas

2016-01-01

This secondary analysis of a large, multi-center Blood and Marrow Transplant Clinical Trials Network (BMT CTN) randomized trial assessed whether patient-reported outcomes (PROs) and socioeconomic status (SES) before hematopoietic stem cell transplantation (HCT) are associated with each other and predictive of clinical outcomes including time to hematopoietic recovery, acute graft-versus-host disease, hospitalization days, and overall survival (OS) among 646 allogeneic and autologous HCT recipients. Pre-transplant Cancer and Treatment Distress (CTXD), Pittsburgh Sleep Quality Index (PSQI), and mental and physical component scores (MCS and PCS) of the SF-36 were correlated with each other and with SES variables. PROs and SES variables were further evaluated as predictors of clinical outcomes, with the PSQI and CTXD evaluated as OS predictors (p<.01 considered significant given multiple testing). Lower attained education was associated with increased distress (p=.002); lower income was related to worse physical functioning (p=.005) and increased distress (p=.008); lack of employment pre-transplant was associated with worse physical functioning (p<.01); unmarried status was associated with worse sleep (p=.003). In this large heterogeneous cohort of HCT recipients, while PROs and SES variables were correlated at baseline, they were not associated with any clinical outcomes. Future research should focus on HCT recipients at greater psychosocial disadvantage. PMID:27565521

Prototypes for Content-Based Image Retrieval in Clinical Practice

PubMed Central

Depeursinge, Adrien; Fischer, Benedikt; Müller, Henning; Deserno, Thomas M

2011-01-01

Content-based image retrieval (CBIR) has been proposed as key technology for computer-aided diagnostics (CAD). This paper reviews the state of the art and future challenges in CBIR for CAD applied to clinical practice. We define applicability to clinical practice by having recently demonstrated the CBIR system on one of the CAD demonstration workshops held at international conferences, such as SPIE Medical Imaging, CARS, SIIM, RSNA, and IEEE ISBI. From 2009 to 2011, the programs of CADdemo@CARS and the CAD Demonstration Workshop at SPIE Medical Imaging were sought for the key word “retrieval” in the title. The systems identified were analyzed and compared according to the hierarchy of gaps for CBIR systems. In total, 70 software demonstrations were analyzed. 5 systems were identified meeting the criterions. The fields of application are (i) bone age assessment, (ii) bone fractures, (iii) interstitial lung diseases, and (iv) mammography. Bridging the particular gaps of semantics, feature extraction, feature structure, and evaluation have been addressed most frequently. In specific application domains, CBIR technology is available for clinical practice. While system development has mainly focused on bridging content and feature gaps, performance and usability have become increasingly important. The evaluation must be based on a larger set of reference data, and workflow integration must be achieved before CBIR-CAD is really established in clinical practice. PMID:21892374

A critical evaluation of the clinical evidence for pomegranate preparations in the prevention and treatment of cardiovascular diseases.

PubMed

Vlachojannis, Christian; Erne, Paul; Schoenenberger, Andreas W; Chrubasik-Hausmann, Sigrun

2015-04-01

This study attempts a critical evaluation of the clinical evidence behind the use of dietary pomegranate preparations in the prevention and treatment of cardiovascular diseases. A search of PubMed on August 10, 2014 identified 228 references, which yielded extractable data from 24 clinical studies of pomegranate preparations. Hand searching identified two further studies. The quality of the studies and evidence of effectiveness of pomegranate were assessed by an established set of conventional criteria. Overall, the study quality was poor. Even in the best studies, indications of benefit did not reach the conventional levels of statistical significance. The only study with a definitive design had a biochemical rather than a clinical endpoint: it showed the expected difference in blood concentrations of myeloperoxidase after a single dose of either pomegranate or placebo. Only 10 of the 26 studies provided HPLC data on the amounts of co-active ingredients in the preparations that were consumed by the subjects. If pomegranate has a role in the prevention and treatment of cardiovascular diseases, there is a pressing need for dose-finding and long-term confirmatory studies. The ultimate endpoint for definitive studies would be mortality, but reductions in blood pressure or demonstrable decreases in atherosclerotic plaques would be useful surrogates. Sample sizes for various assumptions are provided. Future studies need to prove the clinical benefit. Copyright © 2015 John Wiley & Sons, Ltd.

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

Inflammatory Biomarkers Associated with Lethal Rift Valley Fever Encephalitis in the Lewis Rat Model

PubMed Central

Caroline, Amy L.; Kujawa, Michael R.; Oury, Tim D.; Reed, Douglas S.; Hartman, Amy L.

2016-01-01

Rift Valley fever (RVF) is an emerging viral disease that causes significant human and veterinary illness in Africa and the Arabian Peninsula. Encephalitis is one of the severe complications arising from RVF virus (RVFV) infection of people, and the pathogenesis of this form of RVF is completely unknown. We use a novel reproducible encephalitic disease model in rats to identify biomarkers of lethal infection. Lewis rats were infected with RVFV strain ZH501 by aerosol exposure, then sacrificed daily to determine the course of infection and evaluation of clinical, virological, and immunological parameters. Weight loss, fever, and clinical signs occurred during the last 1–2 days prior to death. Prior to onset of clinical indications of disease, rats displayed marked granulocytosis and thrombocytopenia. In addition, high levels of inflammatory chemokines (MCP-1, MCS-F, Gro/KC, RANTES, and IL-1β) were detected first in serum (3–5 dpi) followed by brain (5–7 dpi). The results of this study are consistent with clinical data from human RVF patients and validate Lewis rats as an appropriate small animal model for RVF encephalitis. The biomarkers we identified here will be useful in future studies evaluating the efficacy of novel vaccines and therapeutics. PMID:26779164

Engaging GPs in commissioning: realist evaluation of the early experiences of Clinical Commissioning Groups in the English NHS.

PubMed

McDermott, Imelda; Checkland, Kath; Coleman, Anna; Osipovič, Dorota; Petsoulas, Christina; Perkins, Neil

2017-01-01

Objectives To explore the 'added value' that general practitioners (GPs) bring to commissioning in the English NHS. We describe the experience of Clinical Commissioning Groups (CCGs) in the context of previous clinically led commissioning policy initiatives. Methods Realist evaluation. We identified the programme theories underlying the claims made about GP 'added value' in commissioning from interviews with key informants. We tested these theories against observational data from four case study sites to explore whether and how these claims were borne out in practice. Results The complexity of CCG structures means CCGs are quite different from one another with different distributions of responsibilities between the various committees. This makes it difficult to compare CCGs with one another. Greater GP involvement was important but it was not clear where and how GPs could add most value. We identified some of the mechanisms and conditions which enable CCGs to maximize the 'added value' that GPs bring to commissioning. Conclusion To maximize the value of clinical input, CCGs need to invest time and effort in preparing those involved, ensuring that they systematically gather evidence about service gaps and problems from their members, and engaging members in debate about the future shape of services.

Engaging GPs in commissioning: realist evaluation of the early experiences of Clinical Commissioning Groups in the English NHS

PubMed Central

Checkland, Kath; Coleman, Anna; Osipovič, Dorota; Petsoulas, Christina; Perkins, Neil

2016-01-01

Objectives To explore the ‘added value’ that general practitioners (GPs) bring to commissioning in the English NHS. We describe the experience of Clinical Commissioning Groups (CCGs) in the context of previous clinically led commissioning policy initiatives. Methods Realist evaluation. We identified the programme theories underlying the claims made about GP ‘added value’ in commissioning from interviews with key informants. We tested these theories against observational data from four case study sites to explore whether and how these claims were borne out in practice. Results The complexity of CCG structures means CCGs are quite different from one another with different distributions of responsibilities between the various committees. This makes it difficult to compare CCGs with one another. Greater GP involvement was important but it was not clear where and how GPs could add most value. We identified some of the mechanisms and conditions which enable CCGs to maximize the ‘added value’ that GPs bring to commissioning. Conclusion To maximize the value of clinical input, CCGs need to invest time and effort in preparing those involved, ensuring that they systematically gather evidence about service gaps and problems from their members, and engaging members in debate about the future shape of services. PMID:27151153

Management of intrathecal baclofen therapy for severe acquired brain injury: consensus and recommendations for good clinical practice.

PubMed

De Tanti, Antonio; Scarponi, Federico; Bertoni, Michele; Gasperini, Giulio; Lanzillo, Bernardo; Molteni, Franco; Posteraro, Federico; Vitale, Dino Francesco; Zanpolini, Mauro

2017-08-01

Although widespread in the treatment of generalised spasticity due to severe acquired brain injury, clinical use of intrathecal baclofen administered through an implanted catheter is not yet supported by full scientific evidence. The aim of the study is to provide recommendations for good clinical practice regarding intrathecal baclofen therapy. We used a modified RAND Delphi method to develop consensus-based medical guidelines, involving clinicians who use intrathecal baclofen therapy throughout Italy. The clinicians were asked 38 questions grouped in six areas (patient selection, contraindications for implant, tests prior to implant, method of implant and management of therapy, efficacy evaluation and goal setting, and management of complications). To establish consensus, 75% agreement was required in answers to every question. Consensus was reached on the second round of the Delphi process on 27/38 questions (71%), specifically those regarding identification of objectives, efficacy evaluation, and method of implant and management of therapy, whereas management of complications and contraindications for implant remained critical areas. Despite the limits of our method, a set of recommendations was drawn up for clinical practice in this sector. The study also revealed residual critical areas and indicated future lines of research necessary to reach evidence-based consensus.

Perceptions of Massage Therapists Participating in a Randomized Controlled Trial

PubMed Central

Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather

2015-01-01

Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961

Teaching teamwork: an evaluation of an interprofessional training ward placement for health care students

PubMed Central

Morphet, Julia; Hood, Kerry; Cant, Robyn; Baulch, Julie; Gilbee, Alana; Sandry, Kate

2014-01-01

The establishment of interprofessional teamwork training in the preprofessional health care curriculum is a major challenge for teaching faculties. Interprofessional clinical placements offer an opportunity for teamwork education, as students in various professions can work and learn together. In this sequential, mixed-method study, focus group and survey techniques were used to evaluate students’ educational experiences after 2-week ward-based interprofessional clinical placements. Forty-five senior nursing, medicine, and other health care students cared for patients in hospital wards under professional supervision, with nursing-medicine student “teams” leading care. Thirty-six students attended nine exit focus groups. Five central themes that emerged about training were student autonomy and workload, understanding of other professional roles, communication and shared knowledge, interprofessional teamwork/collaboration, and the “inner circle”, or being part of the unit team. The learning environment was described as positive. In a postplacement satisfaction survey (n=38), students likewise rated the educational experience highly. In practicing teamwork and collaboration, students were able to rehearse their future professional role. We suggest that interprofessional clinical placements be regarded as an essential learning experience for senior preprofessional students. More work is needed to fully understand the effect of this interactive program on students’ clinical learning and preparation for practice. PMID:25028569

Teaching teamwork: an evaluation of an interprofessional training ward placement for health care students.

PubMed

Morphet, Julia; Hood, Kerry; Cant, Robyn; Baulch, Julie; Gilbee, Alana; Sandry, Kate

2014-01-01

The establishment of interprofessional teamwork training in the preprofessional health care curriculum is a major challenge for teaching faculties. Interprofessional clinical placements offer an opportunity for teamwork education, as students in various professions can work and learn together. In this sequential, mixed-method study, focus group and survey techniques were used to evaluate students' educational experiences after 2-week ward-based interprofessional clinical placements. Forty-five senior nursing, medicine, and other health care students cared for patients in hospital wards under professional supervision, with nursing-medicine student "teams" leading care. Thirty-six students attended nine exit focus groups. Five central themes that emerged about training were student autonomy and workload, understanding of other professional roles, communication and shared knowledge, interprofessional teamwork/collaboration, and the "inner circle", or being part of the unit team. The learning environment was described as positive. In a postplacement satisfaction survey (n=38), students likewise rated the educational experience highly. In practicing teamwork and collaboration, students were able to rehearse their future professional role. We suggest that interprofessional clinical placements be regarded as an essential learning experience for senior preprofessional students. More work is needed to fully understand the effect of this interactive program on students' clinical learning and preparation for practice.

[Directions for future development of preventive medicine in Korea].

PubMed

Kim, Joon Youn

2006-05-01

It is the actual state of the medical society in our country that many graduates of medical schools want to be clinicians, and accordingly Korea's medical situation is relatively too focused on curative medicine. However, this situation is changing due to several factors including a growing number of doctors, inappropriate regulations for medical fees, changes in social status of doctors themselves, and excessive competition between doctors. Furthermore, we expect more advances in medical field of Korea since Korean government started to attach great importance to sciences and produced policies to support sciences, and as a result, more and more interest and effort in the fields of basic research including preventive medicine is being attached especially by young doctors as compared against the past. However, decline of clinical medicine fields doesn't always mean bright future for the field of preventive medicine. True future is possible and meaningful only when we prepare for it by ourselves. In other words, as the promising future is closed to one who spares no effort, we shouldn't fear to oppose unknown challenges and simultaneously need to support colleagues who bear such a positive mind. It is the most important thing for our preventive medicine doctors to evaluate the past and the present of preventive medicine and to foster a prospective mind to prepare for the future of preventive medicine. I set forth my several views according to directions for the development of preventive medicine which we already discussed and publicized in the academic circle of preventive medicine. Those directions are recommen dation of clinical preventive medicine, promotion of preventive medicine specialty, fostering the next generations, improving the quality of genetic epidemiologic study, participation in control of environmental pollution and food safety, contribution to chronic disease control, and preparation to role in medical services for unified Korea.

[My hybrid carrier of clinical pathologist].

PubMed

Honda, Takayuki

2011-03-01

In this review, I showed a brief summary of my carrier in multiple special fields (clinical pathologist, anatomical pathologist of lung, respiratory physician and infection control doctor), my studies and my own view of laboratory medicine. We chiefly study pathology of the lung, especially about type II pneumocytes. Type II pneumocytes had abundant surface coat on the apical surface containing a specific carbohydrate structure of Thomsen-Friedenreich (TF) antigen. TF antigen is a marker of type II pneumocytes beyond animal species, and can be used for evaluating activity of various interstitial pneumonia as type II pneumocyte index (number/lmm alveolar length). Three dimensional views generated from thick sections of ordinary processed paraffin blocks showed new information of normal and abnormal lung morphology. Type II pneumocytes linearly located along the elastic fibers forming framework of polygonal alveoli, and in usual interstitial pneumonia, destruction of these elastic fibers were observed. In Japan, roles of a clinical pathologist are not definite as a radiologist, and clinical laboratory in a hospital is recognized as a section only performing blood and chemical tests. Evaluation of the data and participation in diagnosis were not requested. In future, medical doctors devote themselves to treat patients, and clinical pathologists and laboratory technicians have to help the doctors in diagnostic process. Routine tests (blood and urine) are most frequently performed in clinical medicine, but the data are not adequately used. Therefore, a system is necessary for interpreting routine tests and reporting them to other medical staffs.

Patient-Reported Outcomes and Socioeconomic Status as Predictors of Clinical Outcomes after Hematopoietic Stem Cell Transplantation: A Study from the Blood and Marrow Transplant Clinical Trials Network 0902 Trial.

PubMed

Knight, Jennifer M; Syrjala, Karen L; Majhail, Navneet S; Martens, Michael; Le-Rademacher, Jennifer; Logan, Brent R; Lee, Stephanie J; Jacobsen, Paul B; Wood, William A; Jim, Heather S L; Wingard, John R; Horowitz, Mary M; Abidi, Muneer H; Fei, Mingwei; Rawls, Laura; Rizzo, J Douglas

2016-12-01

This secondary analysis of a large, multicenter Blood and Marrow Transplant Clinical Trials Network randomized trial assessed whether patient-reported outcomes (PROs) and socioeconomic status (SES) before hematopoietic stem cell transplantation (HCT) are associated with each other and predictive of clinical outcomes, including time to hematopoietic recovery, acute graft-versus-host disease, hospitalization days, and overall survival (OS) among 646 allogeneic and autologous HCT recipients. Pretransplantation Cancer and Treatment Distress (CTXD), Pittsburgh Sleep Quality Index (PSQI), and mental and physical component scores of the Short-Form 36 were correlated with each other and with SES variables. PROs and SES variables were further evaluated as predictors of clinical outcomes, with the PSQI and CTXD evaluated as OS predictors (P < .01 considered significant given multiple testing). Lower attained education was associated with increased distress (P = .002), lower income was related to worse physical functioning (P = .005) and increased distress (P = .008), lack of employment before transplantation was associated with worse physical functioning (P < .01), and unmarried status was associated with worse sleep (P = .003). In this large heterogeneous cohort of HCT recipients, although PROs and SES variables were correlated at baseline, they were not associated with any clinical outcomes. Future research should focus on HCT recipients at greater psychosocial disadvantage. Copyright © 2016 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology.

PubMed

Buch, Maya H; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

2015-06-01

Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A '0-10' agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes. 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.

Evaluation of neurofeedback in ADHD: the long and winding road.

PubMed

Arns, Martijn; Heinrich, Hartmut; Strehl, Ute

2014-01-01

Among the clinical applications of neurofeedback, most research has been conducted in ADHD. As an introduction a short overview of the general history of neurofeedback will be given, while the main part of the paper deals with a review of the current state of neurofeedback in ADHD. A meta-analysis on neurofeedback from 2009 found large effect sizes for inattention and impulsivity and medium effects sizes for hyperactivity. Since 2009 several new studies, including 4 placebo-controlled studies, have been published. These latest studies are reviewed and discussed in more detail. The review focuses on studies employing (1) semi-active, (2) active, and (3) placebo-control groups. The assessment of specificity of neurofeedback treatment in ADHD is discussed and it is concluded that standard protocols such as theta/beta, SMR and slow cortical potentials neurofeedback are well investigated and have demonstrated specificity. The paper ends with an outlook on future questions and tasks. It is concluded that future controlled clinical trials should, in a next step, focus on such known protocols, and be designed along the lines of learning theory. Copyright © 2013 Elsevier B.V. All rights reserved.

Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis

PubMed Central

Thariani, Rahber; Henry, Norah Lynn; Ramsey, Scott D; Blough, David K; Barlow, Bill; Gralow, Julie R; Veenstra, David L

2014-01-01

Background Breast cancer tumor markers are used by some clinicians to screen for disease recurrence risk. Since there is limited evidence of benefit, additional research may be warranted. Aim To assess the potential value of a randomized clinical trial of breast tumor marker testing in routine follow-up of high-risk, stage II–III breast cancer survivors. Materials & methods We developed a decision-analytic model of tumor marker testing plus standard surveillance every 3–6 months for 5 years. The expected value of sample information was calculated using probabilistic simulations and was a function of: the probability of selecting the optimal monitoring strategy with current versus future information; the impact of choosing the nonoptimal strategy; and the size of the population affected. Results The value of information for a randomized clinical trial involving 9000 women was US$214 million compared with a cost of US$30–60 million to conduct such a trial. The probability of making an alternate, nonoptimal decision and choosing testing versus no testing was 32% with current versus future information from the trial. The impact of a nonoptimal decision was US$2150 and size of population impacted over 10 years was 308,000. The value of improved information on overall survival was US$105 million, quality of life US$37 million and test performance US$71 million. Conclusion Conducting a randomized clinical trial of breast cancer tumor markers appears to offer a good societal return on investment. Retrospective analyses to assess test performance and evaluation of patient quality of life using tumor markers may also offer valuable areas of research. However, alternative investments may offer even better returns in investments and, as such, the trial concept deserves further study as part of an overall research-portfolio evaluation. PMID:24236631

Latin American and Caribbean countries' baseline clinical and policy guidelines for responding to intimate partner violence and sexual violence against women.

PubMed

Stewart, Donna E; Aviles, Raquel; Guedes, Alessandra; Riazantseva, Ekaterina; MacMillan, Harriet

2015-07-15

Violence against women is a global public health problem with negative effects on physical, mental, and reproductive health. The World Health Organization (WHO) has identified intimate partner violence (IPV) and sexual violence (SV) as major targets for prevention and amelioration and recently developed clinical and policy guidelines to assist healthcare providers. This project was undertaken to determine the 2013 baseline national policies and clinical guidelines on IPV and SV within the Latin American and Caribbean (LAC) region to identify strengths and gaps requiring action. Each Pan American Health Organization/World Health Organization Regional Office for the Americas (PAHO/WHO) country focal point was contacted to request their current national policy and clinical guidelines (protocol) on IPV/SV. We augmented this by searching the internet and the United Nations Women website. Each country's policy and clinical guideline (where available) was reviewed and entered into a scoring matrix based on WHO Clinical and Policy Guidelines. A total score for each heading and subheading was developed by adding positive responses to identify LAC regional strengths and gaps. We obtained 15 national policies and 12 national clinical guidelines (protocols) from a total of 18 countries ("response" rate 66.7%). National policies were comprehensive in terms of physical, emotional, and sexual violence and recommended good intersectoral collaboration. The greatest gap was in the training of health-care providers. National Guidelines for women-centered care for IPV/SV survivors were strong in the vital areas of privacy, confidentiality, danger assessment, safety planning, and supportive reactions to disclosure. The largest gaps noted were again in training healthcare professionals and strengthening monitoring and evaluation of services. Baseline measurement of policy and clinical guidelines for IPV/SV in LAC PAHO/WHO member countries at the time of issuing the 2013 WHO Clinical and Policy Guidelines reveals some important strengths, but also serious gaps that need to be addressed. The most pressing needs are for concerted training initiatives for healthcare providers and strengthening multisectoral monitoring and evaluation of services. A future evaluation of national policies, clinical guidelines, monitoring and evaluation will need to be conducted to measure the progress of the required scaling-up process.

Children facing a family member's acute illness: a review of intervention studies.

PubMed

Spath, Mary L

2007-07-01

A review of psycho-educational intervention studies to benefit children adapting to a close (parent, sibling, or grandparent) family member's serious illness was conducted. To review the literature on studies addressing this topic, critique research methods, describe clinical outcomes, and make recommendations for future research efforts. Research citations from 1990 to 2005 from Medline, CINAHL, Health Source: Nursing/Academic Edition, PsycARTICLES, and PsycINFO databases were identified. Citations were reviewed and evaluated for sample, design, theoretical framework, intervention, threats to validity, and outcomes. Reviewed studies were limited to those that included statistical analysis to evaluate interventions and outcomes. Six studies were reviewed. Positive outcomes were reported for all of the interventional strategies used in the studies. Reviewed studies generally lacked a theoretical framework and a control group, were generally composed of small convenience samples, and primarily used non-tested investigator instruments. They were diverse in terms of intervention length and intensity, and measured short-term outcomes related to participant program satisfaction, rather than participant cognitive and behavioral change. The paucity of interventional studies and lack of systematic empirical precision to evaluate intervention effectiveness necessitates future studies that are methodologically rigorous.