Neuropathological Assessment as an Endpoint in Clinical Trial Design.

PubMed

Gentleman, Steve; Liu, Alan King Lun

2018-01-01

Different neurodegenerative conditions can have complex, overlapping clinical presentations that make accurate diagnosis during life very challenging. For this reason, confirmation of the clinical diagnosis still requires postmortem verification. This is particularly relevant for clinical trials of novel therapeutics where it is important to ascertain what disease and/or pathology modifying effects the therapeutics have had. Furthermore, it is important to confirm that patients in the trial actually had the correct clinical diagnosis as this will have a major bearing on the interpretation of trial results. Here we present a simple protocol for pathological assessment of neurodegenerative changes.

A Qualitative Study of Resident Learning in Ambulatory Clinic

ERIC Educational Resources Information Center

Smith, C. Scott; Morris, Magdalena; Francovich, Chris; Hill, William; Gieselman, Janet

2004-01-01

Qualitative analysis of a large ethnographic database from observations of a resident teaching clinic revealed three important findings. The first finding was that breakdown, a situation where an "actor" (such as a person or the group) is not achieving expected effectiveness, was the most important category because of its frequency and explanatory…

Rank-based estimation in the {ell}1-regularized partly linear model for censored outcomes with application to integrated analyses of clinical predictors and gene expression data.

PubMed

Johnson, Brent A

2009-10-01

We consider estimation and variable selection in the partial linear model for censored data. The partial linear model for censored data is a direct extension of the accelerated failure time model, the latter of which is a very important alternative model to the proportional hazards model. We extend rank-based lasso-type estimators to a model that may contain nonlinear effects. Variable selection in such partial linear model has direct application to high-dimensional survival analyses that attempt to adjust for clinical predictors. In the microarray setting, previous methods can adjust for other clinical predictors by assuming that clinical and gene expression data enter the model linearly in the same fashion. Here, we select important variables after adjusting for prognostic clinical variables but the clinical effects are assumed nonlinear. Our estimator is based on stratification and can be extended naturally to account for multiple nonlinear effects. We illustrate the utility of our method through simulation studies and application to the Wisconsin prognostic breast cancer data set.

Enabling professional development in mental health nursing: the role of clinical leadership.

PubMed

Ennis, G; Happell, B; Reid-Searl, K

2015-10-01

Clinical leadership is acknowledged as important to the nursing profession. While studies continue to identify its significance in contributing to positive outcomes for consumers, the role that clinical leadership has in enabling and supporting professional development in mental health nursing is poorly understood. This study utilized a grounded theory methodology to explore the characteristics clinicians consider important for clinical leadership and its significance for mental health nursing in day-to-day clinical practice. Individual face-to-face, semi-structured interviews were conducted with nurses working in mental health settings. Participants described the important role that clinical leaders play in enabling professional development of others through role modelling and clinical teaching. They describe how nurses, whom they perceive as clinical leaders, use role modelling and clinical teaching to influence the professional development of nursing staff and undergraduate nursing students. Attributes such as professionalism and honesty were seen, by participants, as enablers for clinical leaders in effectively and positively supporting the professional development of junior staff and undergraduate nurses in mental health nursing. This paper examines clinical leadership from the perspective of mental health nurses delivering care, and highlights the important role of clinical leaders in supporting professional development in mental health nursing. © 2015 John Wiley & Sons Ltd.

Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use

PubMed Central

Kinoshita, Yoshikazu; Ishimura, Norihisa; Ishihara, Shunji

2018-01-01

Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases including gastroesophageal reflux disease and secondary prevention of aspirin/NSAID-induced ulcers. Although clinically important adverse effects of PPIs can occur, just as with other drugs, those are not frequently observed during or after administration. Thus, PPIs are regarded as relatively safe and considered to be clinically beneficial. Recently, PPIs have become frequently administered to patients with functional gastrointestinal diseases or primary prevention of drug-related gastroduodenal damage, even though their beneficial effects for those conditions have not been fully confirmed. PPIs tend to be given for conditions in which the necessity of the drug has not been clarified, thus otherwise rare adverse effects are presented as clinically relevant. Although several PPI-related adverse effects have been reported, their clinical relevance is not yet clear, since the evidence reported in those studies is not at a high enough level, as the majority are based on retrospective observational studies and the reported hazard ratios are low. It is important to administer PPIs only for patients who will gain a substantial clinical benefit and to continue to investigate their adverse effects with high quality prospective studies. PMID:29605975

Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use.

PubMed

Kinoshita, Yoshikazu; Ishimura, Norihisa; Ishihara, Shunji

2018-04-30

Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases including gastroesophageal reflux disease and secondary prevention of aspirin/NSAID-induced ulcers. Although clinically important adverse effects of PPIs can occur, just as with other drugs, those are not frequently observed during or after administration. Thus, PPIs are regarded as relatively safe and considered to be clinically beneficial. Recently, PPIs have become frequently administered to patients with functional gastrointestinal diseases or primary prevention of drug-related gastroduodenal damage, even though their beneficial effects for those conditions have not been fully confirmed. PPIs tend to be given for conditions in which the necessity of the drug has not been clarified, thus otherwise rare adverse effects are presented as clinically relevant. Although several PPI-related adverse effects have been reported, their clinical relevance is not yet clear, since the evidence reported in those studies is not at a high enough level, as the majority are based on retrospective observational studies and the reported hazard ratios are low. It is important to administer PPIs only for patients who will gain a substantial clinical benefit and to continue to investigate their adverse effects with high quality prospective studies.

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

PubMed

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

2017-01-01

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

Factors influencing the perceived quality of clinical supervision of occupational therapists in a large Australian state.

PubMed

Martin, Priya; Kumar, Saravana; Lizarondo, Lucylynn; Tyack, Zephanie

2016-10-01

Clinical supervision is important for effective health service delivery, professional development and practice. Despite its importance there is a lack of evidence regarding the factors that improve its quality. This study aimed to investigate the factors that influence the quality of clinical supervision of occupational therapists employed in a large public sector health service covering mental health, paediatrics, adult physical and other practice areas. A mixed method, sequential explanatory study design was used consisting of two phases. This article reports the quantitative phase (Phase One) which involved administration of the Manchester Clinical Supervision Scale (MCSS-26) to 207 occupational therapists. Frequency of supervision sessions, choice of supervisor and the type of supervision were found to be the predictor variables with a positive and significant influence on the quality of clinical supervision. Factors such as age, length of supervision and the area of practice were found to be the predictor variables with a negative and significant influence on the quality of clinical supervision. Factors that influence the perceived quality of clinical supervision among occupational therapists have been identified. High quality clinical supervision is an important component of clinical governance and has been shown to be beneficial to practitioners, patients and the organisation. Information on factors that make clinical supervision effective identified in this study can be added to existing supervision training and practices to improve the quality of clinical supervision. © 2016 Occupational Therapy Australia.

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research.

PubMed

Phillips, Kathryn A; Deverka, Patricia A; Sox, Harold C; Khoury, Muin J; Sandy, Lewis G; Ginsburg, Geoffrey S; Tunis, Sean R; Orlando, Lori A; Douglas, Michael P

2017-10-01

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address.Genet Med advance online publication 13 April 2017.

Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research

PubMed Central

Phillips, Kathryn A.; Deverka, Patricia A.; Sox, Harold C.; Khoury, Muin J.; Sandy, Lewis G.; Ginsburg, Geoffrey S.; Tunis, Sean R.; Orlando, Lori A.; Douglas, Michael P.

2017-01-01

Comparative effectiveness research (CER) in genomic medicine (GM) measures the clinical utility of using genomic information to guide clinical care in comparison to appropriate alternatives. We summarized findings of high-quality systematic reviews that compared the analytic and clinical validity and clinical utility of GM tests. We focused on clinical utility findings to summarize CER-derived evidence about GM and identify evidence gaps and future research needs. We abstracted key elements of study design, GM interventions, results, and study quality ratings from 21 systematic reviews published in 2010 through 2015. More than half (N = 13) of the reviews were of cancer-related tests. All reviews identified potentially important clinical applications of the GM interventions, but most had significant methodological weaknesses that largely precluded any conclusions about clinical utility. Twelve reviews discussed the importance of patient-centered outcomes, although few described evidence about the impact of genomic medicine on these outcomes. In summary, we found a very limited body of evidence about the effect of using genomic tests on health outcomes and many evidence gaps for CER to address. Genet Med advance online publication 13 April 2017 PMID:28406488

What are the effective ways to translate clinical leadership into health care quality improvement?

PubMed

McSherry, Robert; Pearce, Paddy

2016-01-01

The presence and/or absence of effective leaders in health care can have a stark consequence on the quality and outcomes of care. The delivery of safe, quality, compassionate health care is dependent on having effective clinical leaders at the frontline. In light of the Kirkup and Francis reports, this article explores some ways of translating clinical leadership into health care quality improvement. This is achieved by exploring what is clinical leadership and why and how this is important to health care quality improvement, clinical leadership, and a duty of candor, along with the importance clinical leadership plays in the provision of quality care improvement and outcomes. Clinical leaders are not predefined roles but emerge from the complex clinical setting by gaining an acquired expertise and from how they then internalize this to develop and facilitate sound relationships within a team. Clinical leaders are effective in facilitating innovation and change through improvement. This is achieved by recognizing, influencing, and empowering individuals through effective communication in order to share and learn from and with each other in practice. The challenge for health care organizations in regard to creating organizational cultures where a duty of candor exists is not to reinvent the wheel by turning something that is simple into something complex, which can become confusing to health care workers, patients, and the public. By focusing on the clinical leader's role and responsibilities we would argue they play a crucial and pivotal role in influencing, facilitating, supporting, and monitoring that this duty of candor happens in practice. This may be possible by highlighting where and how the duty of candor can be aligned within existing clinical governance frameworks.

Do primary care professionals agree about progress with implementation of primary care teams: results from a cross sectional study.

PubMed

Tierney, E; O'Sullivan, M; Hickey, L; Hannigan, A; May, C; Cullen, W; Kennedy, N; Kineen, L; MacFarlane, A

2016-11-22

Primary care is the cornerstone of healthcare reform with policies across jurisdictions promoting interdisciplinary team working. The effective implementation of such health policies requires understanding the perspectives of all actors. However, there is a lack of research about health professionals' views of this process. This study compares Primary Healthcare Professionals' perceptions of the effectiveness of the Primary Care Strategy and Primary Care Team (PCT) implementation in Ireland. Design and Setting: e-survey of (1) General Practitioners (GPs) associated with a Graduate Medical School (N = 100) and (2) Primary Care Professionals in 3 of 4 Health Service Executive (HSE) regions (N = 2309). After piloting, snowball sampling was used to administer the survey. Descriptive analysis was carried out using SPSS. Ratings across groups were compared using non-parametric tests. There were 569 responses. Response rates varied across disciplines (71 % for GPs, 22 % for other Primary Healthcare Professionals (PCPs). Respondents across all disciplines viewed interdisciplinary working as important. Respondents agreed on lack of progress of implementation of formal PCTs (median rating of 2, where 1 is no progress at all and 5 is complete implementation). GPs were more negative about the effectiveness of the Strategy to promote different disciplines to work together (median rating of 2 compared to 3 for clinical therapists and 3.5 for nurses, P = 0.001). Respondents identified resources and GP participation as most important for effective team working. Protected time for meetings and capacity to manage workload for meetings were rated as very important factors for effective team working by GPs, clinical therapists and nurses. A building for co-location of teams was rated as an important factor by nurses and clinical therapists though GPs rated it as less important. Payment to attend meetings and contractual arrangements were considered important factors by GPs but not by nurses or clinical therapists. PCPs and GPs agree there is limited PCT implementation. GPs are most negative about this implementation. There is some disagreement about which resources are most important for effective PCT working. These findings provide valuable data for clinicians and policy makers about implementation of interdisciplinary teams in primary care.

Factors influencing radiation therapy student clinical placement satisfaction

PubMed Central

Bridge, Pete; Carmichael, Mary-Ann

2014-01-01

Introduction: Radiation therapy students at Queensland University of Technology (QUT) attend clinical placements at five different clinical departments with varying resources and support strategies. This study aimed to determine the relative availability and perceived importance of different factors affecting student support while on clinical placement. The purpose of the research was to inform development of future support mechanisms to enhance radiation therapy students’ experience on clinical placement. Methods: This study used anonymous Likert-style surveys to gather data from years 1 and 2 radiation therapy students from QUT and clinical educators from Queensland relating to availability and importance of support mechanisms during clinical placements in a semester. Results: The study findings demonstrated student satisfaction with clinical support and suggested that level of support on placement influenced student employment choices. Staff support was perceived as more important than physical resources; particularly access to a named mentor, a clinical educator and weekly formative feedback. Both students and educators highlighted the impact of time pressures. Conclusions: The support offered to radiation therapy students by clinical staff is more highly valued than physical resources or models of placement support. Protected time and acknowledgement of the importance of clinical education roles are both invaluable. Joint investment in mentor support by both universities and clinical departments is crucial for facilitation of effective clinical learning. PMID:26229635

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

PubMed

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

2011-12-01

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

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

PubMed Central

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

2013-01-01

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

From clinical trial to prescription.

PubMed

Carpenter, William T

2002-03-01

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

Effectiveness of low-dose pasireotide in a patient with Cushing’s disease: antiproliferative effect and predictivity of a short pasireotide suppression test

PubMed Central

Grossrubatscher, Erika; Zampetti, Benedetta; Dalino Ciaramella, Paolo; Doneda, Paola; Loli, Paola

2015-01-01

Key Clinical Message This case shows efficacy of low-dose pasireotide in biochemical and clinical control of severe hypercortisolism and in tumor volume reduction in a patient with an ACTH-secreting macroadenoma. The drug may be an option for long-term treatment in some patients where control of tumor mass is an important clinical endpoint. PMID:26331021

Editorial: The continuing contributions of multimodal treatment of attention over nearly two decades to initial attention-deficit hyperactivity disorder pharmacotherapy and long-term clinical course.

PubMed

Bloch, Michael H

2017-06-01

The initial results of the Multimodal Treatment of Attention Deficit Hyperactivity Disorder (MTA) trial had profound effects on the way that Attention-Deficit Hyperactivity Disorder (ADHD) is managed clinically. Children from the original MTA cohort as well as a control group have been followed longitudinally for well over a decade and are beginning to provide important data regarding the long-term clinical course, treatment and consequences of ADHD into adulthood. Two articles in this issue of JCPP highlight important contributions from the MTA cohort. Swanson et al. highlights the potential long-term effects of stimulants on height whereas Sibley et al. highlights the importance of using multiple informants in assessing adulthood ADHD symptoms similar to children and suggest that current DSM criteria for ADHD may be overly stringent. © 2017 Association for Child and Adolescent Mental Health.

Approaches to preparing young scholars for careers in interdisciplinary team science.

PubMed

Begg, Melissa D; Crumley, Gene; Fair, Alecia M; Martina, Camille A; McCormack, Wayne T; Merchant, Carol; Patino-Sutton, Cecilia M; Umans, Jason G

2014-01-01

To succeed as a biomedical researcher, the ability to flourish in interdisciplinary teams of scientists is becoming ever more important. Institutions supported by the Clinical and Translational Science Awards (CTSAs) from the National Institutes of Health have a specific mandate to educate the next generation of clinical and translational researchers. While they strive to advance integrated and interdisciplinary approaches to education and career development in clinical and translational science, general approaches and evaluation strategies may differ, as there is no single, universally accepted or standardized approach. It is important, therefore, to learn about the different approaches used to determine what is effective. We implemented a Web-based survey distributed to education leaders at the 60 funded CTSA institutions; 95% responded to the survey, which included questions on the importance of preparation for interdisciplinary team science careers, methods used to provide such training, and perceived effectiveness of these training programs. The vast majority (86%) of education leaders reported that such training is important, and about half (52%) of the institutions offer such training. Methods of training most often take the form of courses and seminars, both credit bearing and noncredit. These efforts are, by and large, perceived as effective by the training program leaders, although long-term follow-up of trainees would be required to fully evaluate ultimate effectiveness. Results from the survey suggest that CTSA education directors believe that specific training in interdisciplinary team science for young investigators is very important, but few methodologies are universally practiced in CTSA institutions to provide training or to assess performance. Four specific recommendations are suggested to provide measurable strategic goals for education in team science in the context of clinical and translational research.

The development of evidence-based guidelines in dentistry.

PubMed

Faggion, C M

2013-02-01

Use of guidelines is an important means of reducing the gap between research and clinical practice. Sound and unbiased information should be available to enable dental professionals to provide better clinical treatment for their patients. The development of clinical guidelines in dentistry should follow standard and transparent methodology. The purpose of this article is to propose important steps for developing evidence-based clinical recommendations in dentistry. Initially, dental guidelines should be extensively sought and assessed to answer focused clinical questions. If there is a paucity of guidelines or if existing guidelines are not of good methodological quality, systematic reviews should be searched or conducted to serve as a basis for the development of evidence-based guidelines. When systematic reviews are produced, they should be rigorous in order to provide the best evidence possible. In the last phase of the process, the overall quality of evidence should be scrutinized and assessed, together with other factors (balance between treatment effects and side effects, patients' values, and cost-effectiveness of therapy) to determine the strength of recommendations. It is expected this approach will result in the development of sound clinical guidelines and consequent improvement of dental treatment.

A controlled evaluation of case clinical effect coding by poison center specialists for detection of WMD scenarios.

PubMed

Beuhler, Michael C; Wittler, Mary A; Ford, Marsha; Dulaney, Anna R

2011-08-01

Many public health entities employ computer-based syndromic surveillance to monitor for aberrations including possible exposures to weapons of mass destruction (WMD). Often, this is done by screening signs and symptoms reported for cases against syndromic definitions. Poison centers (PCs) may offer significant contributions to public health surveillance because of their detailed clinical effect data field coding and real-time data entry. Because improper clinical effect coding may impede syndromic surveillance, it is important to assess this accuracy for PCs. An AAPCC-certified regional PC assessed the accuracy of clinical effect coding by specialists in poison information (SPIs) listening to audio recordings of standard cases. Eighteen different standardized cases were used, consisting of six cyanide, six botulism, and six control cases. Cases were scripted to simulate clinically relevant telephone conversations and converted to audio recordings. Ten SPIs were randomly selected from the center's staff to listen to and code case information from the recorded cases. Kappa scores and the percentage of correctly coding a present clinical effect were calculated for individual clinical effects summed over all test cases along with corresponding 95% confidence intervals. The rate of the case coding by the SPIs triggering the PC's automated botulism and cyanide alerts was also determined. The kappa scores and the percentage of correctly coding a present clinical effect varied depending on the specific clinical effect, with greater accuracy observed for the clinical effects of vomiting and agitation/irritability, and poor accuracy observed for the clinical effects of visual defect and anion gap increase. Lack of correct coding resulted in only 60 and 86% of the cases that met the botulism and cyanide surveillance definitions, respectively, triggering the corresponding alert. There was no difference observed in the percentage of coding a present clinical effect between certified (9.0 years experience) and non-certified (2.4 years experience) specialists. There were no cases of coding errors that resulted in the triggering of a false positive alert. The success of syndromic surveillance depends on accurate coding of signs and symptoms. Although PCs generally contribute high-quality data to public health surveillance, it is important to recognize this potential weak link in surveillance methods.

Effectiveness of a Simulated Clinical Examination in the Assessment of the Clinical Competencies of Entry-Level Trainees in a Family Medicine Residency Programme

ERIC Educational Resources Information Center

Curran, Vernon R.; Butler, Roger; Duke, Pauline; Eaton, William H.; Moffatt, Scott M.; Sherman, Greg P.; Pottle, Madge

2012-01-01

Clinical competence is a multidimensional concept and encompasses a variety of skills including procedural, problem-solving and clinical judgement. The initial stages of postgraduate medical training are believed to be a particularly important time for the development of clinical skill competencies. This study reports on an evaluation of a…

Design and analysis issues for economic analysis alongside clinical trials.

PubMed

Marshall, Deborah A; Hux, Margaret

2009-07-01

Clinical trials can offer a valuable and efficient opportunity to collect the health resource use and outcomes data for economic evaluation. However, economic and clinical studies differ fundamentally in the question they seek to answer. The design and analysis of trial-based cost-effectiveness studies require special consideration, which are reviewed in this article. Traditional randomized controlled trials, using an experimental design with a controlled protocol, are designed to measure safety and efficacy for product registration. Cost-effectiveness analysis seeks to measure effectiveness in the context of routine clinical practice, and requires collection of health care resources to allow estimation of cost over an equal timeframe for each treatment alternative. In assessing suitability of a trial for economic data collection, the comparator treatment and other protocol factors need to reflect current clinical practice and the trial follow-up must be sufficiently long to capture important costs and effects. The broadest available population and a measure of effectiveness reflecting important benefits for patients are preferred for economic analyses. Special analytical issues include dealing with missing and censored cost data, assessing uncertainty of the incremental cost-effectiveness ratio, and accounting for the underlying heterogeneity in patient subgroups. Careful consideration also needs to be given to data from multinational studies since practice patterns can differ across countries. Although clinical trials can be an efficient opportunity to collect data for economic evaluation, careful consideration of the suitability of the study design, and appropriate analytical methods must be applied to obtain rigorous results.

Reliable jitter and shimmer measurements in voice clinics: the relevance of vowel, gender, vocal intensity, and fundamental frequency effects in a typical clinical task.

PubMed

Brockmann, Meike; Drinnan, Michael J; Storck, Claudio; Carding, Paul N

2011-01-01

The aims of this study were to examine vowel and gender effects on jitter and shimmer in a typical clinical voice task while correcting for the confounding effects of voice sound pressure level (SPL) and fundamental frequency (F(0)). Furthermore the relative effect sizes of vowel, gender, voice SPL, and F(0) were assessed, and recommendations for clinical measurements were derived. With this cross-sectional single cohort study, 57 healthy adults (28 women, 29 men) aged 20-40 years were investigated. Three phonations of /a/, /o/, and /i/ at "normal" voice loudness were analyzed using Praat (software). The effects of vowel, gender, voice SPL, and F(0) on jitter and shimmer were assessed using descriptive and inferential (analysis of covariance) statistics. The effect sizes were determined with the eta-squared statistic. Vowels, gender, voice SPL, and F(0), each had significant effects either on jitter or on shimmer, or both. Voice SPL was the most important factor, whereas vowel, gender, and F(0) effects were comparatively small. Because men had systematically higher voice SPL, the gender effects on jitter and shimmer were smaller when correcting for SPL and F(0). Surprisingly, in clinical assessments, voice SPL has the single biggest impact on jitter and shimmer. Vowel and gender effects were clinically important, whereas fundamental frequency had a relatively small influence. Phonations at a predefined voice SPL (80 dB minimum) and vowel (/a/) would enhance measurement reliability. Furthermore, gender-specific thresholds applying these guidelines should be established. However, the efficiency of these measures should be verified and tested with patients. Copyright © 2011 The Voice Foundation. All rights reserved.

Exchanging clinical knowledge via Internet.

PubMed

Buchan, I E; Hanka, R

1997-11-01

The need for effective and efficient exchange of clinical knowledge is increasing. Paper based methods for managing clinical knowledge are not meeting the demand for knowledge and this has undoubtedly contributed to the widely reported failures of clinical guidelines. Internet affords both opportunities and dangers for clinical knowledge. Systems such as Wax have demonstrated the importance of intuitive structure in the management of knowledge. We report on a new initiative for the global management of clinical knowledge.

Bactericidal effects of bioactive glasses on clinically important aerobic bacteria.

PubMed

Munukka, Eveliina; Leppäranta, Outi; Korkeamäki, Mika; Vaahtio, Minna; Peltola, Timo; Zhang, Di; Hupa, Leena; Ylänen, Heimo; Salonen, Jukka I; Viljanen, Matti K; Eerola, Erkki

2008-01-01

Bioactive glasses (BAGs) have been studied for decades for clinical use, and they have found many dental and orthopedic applications. BAGs have also been shown to have an antibacterial effect e.g., on some oral microorganisms. In this extensive work we show that six powdered BAGs and two sol-gel derived materials have a clear antibacterial effect on 29 clinically important bacterial species. We also incorporated a rapid and accurate flow cytometric (FCM) method to calculate and standardize the numbers of viable bacteria inoculated in the suspensions used in the tests for antibacterial activity. In all materials tested growth inhibition could be demonstrated, although the concentration and time needed for the effect varied depending on the BAG. The most effective glass was S53P4, which had a clear growth-inhibitory effect on all pathogens tested. The sol-gel derived materials CaPSiO and CaPSiO II also showed a strong antibacterial effect. In summary, BAGs were found to clearly inhibit the growth of a wide selection of bacterial species causing e.g., infections on the surfaces of prostheses in the body after implantation.

General Anesthetics to Treat Major Depressive Disorder: Clinical Relevance and Underlying Mechanisms.

PubMed

Vutskits, Laszlo

2018-01-01

Major depressive disorder is a frequent and devastating psychological condition with tremendous public health impact. The underlying pathophysiological mechanisms involve abnormal neurotransmission and a relatedly impaired synaptic plasticity. Since general anesthetics are potent modulators of neuronal activity and, thereby, can exert long-term context-dependent impact on neural networks, an intriguing hypothesis is that these drugs could enhance impaired neural plasticity associated with certain psychiatric diseases. Clinical observations over the past few decades appear to confirm this possibility. Indeed, equipotency of general anesthesia alone in comparison with electroconvulsive therapy under general anesthesia has been demonstrated in several clinical trials. Importantly, in the past 15 years, intravenous administration of subanesthetic doses of ketamine have also been demonstrated to have rapid antidepressant effects. The molecular, cellular, and network mechanisms underlying these therapeutic effects have been partially identified. Although several important questions remain to be addressed, the ensemble of these experimental and clinical observations opens new therapeutic possibilities in the treatment of depressive disorders. Importantly, they also suggest a new therapeutic role for anesthetics that goes beyond their principal use in the perioperative period to facilitate surgery.

Osteoarthritis subpopulations and implications for clinical trial design

PubMed Central

2011-01-01

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

[Quality assurance and quality improvement in medical practice. Part 3: Clinical audit in medical practice].

PubMed

Godény, Sándor

2012-02-05

The first two articles in the series were about the definition of quality in healthcare, the quality approach, the importance of quality assurance, the advantages of quality management systems and the basic concepts and necessity of evidence based medicine. In the third article the importance and basic steps of clinical audit are summarised. Clinical audit is an integral part of quality assurance and quality improvement in healthcare, that is the responsibility of any practitioner involved in medical practice. Clinical audit principally measures the clinical practice against clinical guidelines, protocols and other professional standards, and sometimes induces changes to ensure that all patients receive care according to principles of the best practice. The clinical audit can be defined also as a quality improvement process that seeks to identify areas for service improvement, develop and carry out plans and actions to improve medical activity and then by re-audit to ensure that these changes have an effect. Therefore, its aims are both to stimulate quality improvement interventions and to assess their impact in order to develop clinical effectiveness. At the end of the article key points of quality assurance and improvement in medical practice are summarised.

[Treatment with inhibitors of new oral direct anticoagulants in patients with severe bleedings or urgent surgical procedures. The new dabigatran antidote: the place of idarucizumab in clinical practice].

PubMed

Boda, Zoltán

2016-03-20

Only vitamin K antagonists could be applied as oral anticoagulants over the past six decades. Coumarols have narrow therapeutic range, and unpredictable anticoagulant effects are resulted by multiple drug interactions. Therefore, regular routine monitoring of the international normalized ratio is necessary. There are two groups of factor-specific anticoagulants: molecules with anti-FIIa (dabigatran) and anti-FXa (rivaroxaban, apixaban and edoxaban) effect. Author summarizes the most important clinical features of the new oral anticoagulants, their indications and the possibilities of laboratory controls. Bleedings are the most important side effects of anticoagulants. This review summarizes the current published evidences for new oral anticoagulants reversal (non-specific and specific) agents, especially in cases with severe acute bleedings or urgent surgery procedures. It reports on how to use inhibitors, the recommended doses and the most important clinical results. The review focuses on idarucizumab - already approved by the U.S. Food and Drug Administration and the European Medicines Agency - which has a key role as the first specific inhibitor of dabigatran.

Predictors of clinic satisfaction among adult survivors of childhood cancer.

PubMed

Absolom, Kate; Greenfield, Diana; Ross, Richard; Horne, Beverly; Davies, Helena; Glaser, Adam; Simpson, Adrian; Waite, Heather; Eiser, Christine

2006-07-01

Childhood cancer survivors experience a wide range of late-effects. As survival rates improve, follow-up in paediatric clinics becomes less feasible, and alternative models of care have been proposed. In this study, satisfaction among those attending a traditional paediatric late-effects clinic was compared with a multi-disciplinary clinic in an adult setting. Survivors (adult clinic n=93, paediatric clinic n=105, age 16-39 years) completed measures of symptoms, understanding of vulnerability to late-effects, purpose of follow-up, satisfaction and number of topics discussed. Predictors of satisfaction were: number of topics discussed, greater understanding of the purpose of follow-up and sex. Females, and those reporting longer waiting time were less satisfied. Aspects of clinic organisation, including shorter waiting times and opportunities to discuss health concerns, are more important in determining patient satisfaction than clinic type. Survivors' understanding of the purpose of follow-up is also integral in determining satisfaction.

Comparative effectiveness research and its utility in In-clinic practice

PubMed Central

Dang, Amit; Kaur, Kirandeep

2016-01-01

One of the important components of patient-centered healthcare is comparative effectiveness research (CER), which aims at generating evidence from the real-life setting. The primary purpose of CER is to provide comparative information to the healthcare providers, patients, and policy makers about the standard of care available. This involves research on clinical questions unanswered by the explanatory trials during the regulatory approval process. Main methods of CER involve randomized controlled trials and observational methods. The limitations of these two methods have been overcome with the help of new statistical methods. After the evidence generation, it is equally important to communicate the results to all the interested organizations. CER is beginning to have its impact in the clinical practice as its results become part of the clinical practice guidelines. CER will have far-reaching scientific and financial impact. CER will make both the treating physician and the patient equally responsible for the treatment offered. PMID:26955571

Health economics in clinical research.

PubMed

Manns, Braden J

2015-01-01

The pressure for health care systems to provide more resource intensive health care and newer, more costly, therapies is significant, despite limited health care budgets. As such, demonstration that a new therapy is effective is no longer sufficient to ensure that it is funded within publicly funded health care systems. The impact of a therapy on health care costs is also an important consideration for decision-makers who must allocate scarce resources. The clinical benefits and costs of a new therapy can be estimated simultaneously using economic evaluation, the strengths and limitations of which are discussed herein. In addition, this chapter includes discussion of the important economic outcomes that can be collected within a clinical trial (alongside the clinical outcome data) enabling consideration of the impact of the therapy on overall resource use, thus enabling performance of an economic evaluation, if the therapy is shown to be effective.

Effect of Educational Package on Lifestyle of Primiparous Mothers during Postpartum Period: A Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Khodabandeh, Farzaneh; Mirghafourvand, Mojgan; KamaliFard, Mahin; Mohammad-Alizadeh-Charandabi, Sakineh; Asghari Jafarabadi, Mohammad

2017-01-01

A healthy lifestyle is important for mothers during the postpartum period. This study was conducted to determine the effects of a lifestyle educational package in primiparous women. This randomized clinical trial was conducted on 220 mothers assigned to two groups using block randomization. In the intervention group, the mothers received…

Students' Perception of Important Teaching Behaviors in Classroom and Clinical Environments of a Community College Nursing and Dental Hygiene Education Program

ERIC Educational Resources Information Center

Kimbrough-Walls, Vickie J.

2012-01-01

Student success is dependent on effective instruction. Yet, effective teaching is difficult to define and described differently by students, faculty, and administrators. Nursing and dental hygiene education programs require faculty to teach in both classroom and clinical environments. However, accreditation agencies for these programs mandate…

Inhibition of serotonin transporters disrupts the enhancement of fear memory extinction by 3,4-methylenedioxymethamphetamine (MDMA).

PubMed

Young, Matthew B; Norrholm, Seth D; Khoury, Lara M; Jovanovic, Tanja; Rauch, Sheila A M; Reiff, Collin M; Dunlop, Boadie W; Rothbaum, Barbara O; Howell, Leonard L

2017-10-01

3,4-Methylenedioxymethamphetamine (MDMA) persistently improves symptoms of post-traumatic stress disorder (PTSD) when combined with psychotherapy. Studies in rodents suggest that these effects can be attributed to enhancement of fear memory extinction. Therefore, MDMA may improve the effects of exposure-based therapy for PTSD, particularly in treatment-resistant patients. However, given MDMA's broad pharmacological profile, further investigation is warranted before moving to a complex clinical population. We aimed to inform clinical research by providing a translational model of MDMA's effect, and elucidating monoaminergic mechanisms through which MDMA enhances fear extinction. We explored the importance of monoamine transporters targeted by MDMA to fear memory extinction, as measured by reductions in conditioned freezing and fear-potentiated startle (FPS) in mice. Mice were treated with selective inhibitors of individual monoamine transporters prior to combined MDMA treatment and fear extinction training. MDMA enhanced the lasting extinction of FPS. Acute and chronic treatment with a 5-HT transporter (5-HTT) inhibitor blocked MDMA's effect on fear memory extinction. Acute inhibition of dopamine (DA) and norepinephrine (NE) transporters had no effect. 5-HT release alone did not enhance extinction. Blockade of MDMA's effect by 5-HTT inhibition also downregulated 5-HT 2A -mediated behavior, and 5-HT 2A antagonism disrupted MDMA's effect on extinction. We validate enhancement of fear memory extinction by MDMA in a translational behavioral model, and reveal the importance of 5-HTT and 5-HT 2A receptors to this effect. These observations support future clinical research of MDMA as an adjunct to exposure therapy, and provide important pharmacological considerations for clinical use in a population frequently treated with 5-HTT inhibitors.

Effects of disclosing financial interests on attitudes toward clinical research.

PubMed

Weinfurt, Kevin P; Hall, Mark A; Dinan, Michaela A; DePuy, Venita; Friedman, Joëlle Y; Allsbrook, Jennifer S; Sugarman, Jeremy

2008-06-01

The effects of disclosing financial interests to potential research participants are not well understood. To examine the effects of financial interest disclosures on potential research participants' attitudes toward clinical research. Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research.

The Role of Surrogate Endpoints in the Evaluation of Efficacy and Safety of Therapeutic Interventions in Diabetes Mellitus

PubMed Central

Wieczorek, Aleksandra; Rys, Przemyslaw; Skrzekowska-Baran, Iwona; Malecki, Maciej

2008-01-01

In this paper, we examine the concept of surrogate endpoints (i.e. substitute outcome measures) and review their use in clinical trials involving therapies for diabetes mellitus using the example of metformin. Trials such as DCCT and UKPDS, in which patient-important endpoints were evaluated, are relatively rare in diabetology. Clinical decisions, therefore, are often based on evidence obtained using surrogate outcomes, usually fasting or postprandial glycemia or glycated hemoglobin level. In contrast to patient-important endpoints, surrogates do not describe direct clinical benefit to the patient. However, a proven association between a surrogate and patient-important endpoint is essential to draw appropriate therapeutic conclusions. In the process of new drug development, the duration of follow-up, sample size and methodology of the studies initially available are often inadequate to demonstrate the effect of the intervention on patient-important endpoints. Evidence concerning the effect of an intervention on surrogate outcomes usually comes first, followed only later by reports describing its influence on patient-important endpoints. Metformin may serve as an example in several ways. The first publications reported beneficial effects on glycemic control and body weight. Outcomes from the subsequent UKPDS study suggested the patient-important efficacy of metformin measured as a reduction in mortality and a decrease in the incidence of diabetic complications, including myocardial infarction. This reasoning process worked for some but not all strategies. It is particularly questionable whether a change in surrogate endpoint was associated with a potential deterioration in patient-important outcomes. Defining the general relationship between surrogates widely used as measures of metabolic control and patient-important endpoints remains an important challenge in contemporary diabetology. PMID:19099084

The role of surrogate endpoints in the evaluation of efficacy and safety of therapeutic interventions in diabetes mellitus.

PubMed

Wieczorek, Aleksandra; Rys, Przemyslaw; Skrzekowska-Baran, Iwona; Malecki, Maciej

2008-01-01

In this paper, we examine the concept of surrogate endpoints (i.e. substitute outcome measures) and review their use in clinical trials involving therapies for diabetes mellitus using the example of metformin. Trials such as DCCT and UKPDS, in which patient-important endpoints were evaluated, are relatively rare in diabetology. Clinical decisions, therefore, are often based on evidence obtained using surrogate outcomes, usually fasting or postprandial glycemia or glycated hemoglobin level. In contrast to patient-important endpoints, surrogates do not describe direct clinical benefit to the patient. However, a proven association between a surrogate and patient-important endpoint is essential to draw appropriate therapeutic conclusions. In the process of new drug development, the duration of follow-up, sample size and methodology of the studies initially available are often inadequate to demonstrate the effect of the intervention on patient-important endpoints. Evidence concerning the effect of an intervention on surrogate outcomes usually comes first, followed only later by reports describing its influence on patient-important endpoints. Metformin may serve as an example in several ways. The first publications reported beneficial effects on glycemic control and body weight. Outcomes from the subsequent UKPDS study suggested the patient-important efficacy of metformin measured as a reduction in mortality and a decrease in the incidence of diabetic complications, including myocardial infarction. This reasoning process worked for some but not all strategies. It is particularly questionable whether a change in surrogate endpoint was associated with a potential deterioration in patient-important outcomes. Defining the general relationship between surrogates widely used as measures of metabolic control and patient-important endpoints remains an important challenge in contemporary diabetology.

Inflammation in Depression and the Potential for Anti-Inflammatory Treatment

PubMed Central

Köhler, Ole; Krogh, Jesper; Mors, Ole; Benros, Michael Eriksen

2016-01-01

Accumulating evidence supports an association between depression and inflammatory processes, a connection that seems to be bidirectional. Clinical trials have indicated antidepressant treatment effects for anti-inflammatory agents, both as add-on treatment and as monotherapy. In particular, nonsteroidal anti-inflammatory drugs (NSAIDs) and cytokine-inhibitors have shown antidepressant treatment effects compared to placebo, but also statins, poly-unsaturated fatty acids, pioglitazone, minocycline, modafinil, and corticosteroids may yield antidepressant treatment effects. However, the complexity of the inflammatory cascade, limited clinical evidence, and the risk for side effects stress cautiousness before clinical application. Thus, despite proof-of-concept studies of anti-inflammatory treatment effects in depression, important challenges remain to be investigated. Within this paper, we review the association between inflammation and depression together with the current evidence on use of anti-inflammatory treatment in depression. Based on this, we address the questions and challenges that seem most important and relevant to future studies, such as timing, most effective treatment lengths and identification of subgroups of patients potentially responding better to different anti-inflammatory treatment regimens. PMID:27640518

Informed consent process: A step further towards making it meaningful!

PubMed Central

Kadam, Rashmi Ashish

2017-01-01

Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process. PMID:28828304

An evidence-based practice-oriented review focusing on canagliflozin in the management of type 2 diabetes

PubMed Central

Messana, Joseph A; Schwartz, Stanley S; Townsend, Raymond R

2017-01-01

Caring for patients with type 2 diabetes mellitus (T2DM) has entered an era with many recent additions to the regimens used to clinically control their hyperglycemia. The most recent class of agents approved by the Food and Drug Administration (FDA) for T2DM is the sodium–glucose-linked transporter type 2 (SGLT2) inhibitors, which work principally in the proximal tubule of the kidney to block filtered glucose reabsorption. In the few years attending this new class arrival in the market, there has been a great deal of interest generated by the novel mechanism of action of SGLT2 inhibitors and by recent large outcome trials suggesting benefit on important clinical outcomes such as death, cardiovascular disease and kidney disease progression. In this review, we focus on canagliflozin, the first-in-class marketed SGLT2 inhibitor in the USA. In some cases, we included data from other SGLT2 inhibitors, such as outcomes in clinical trials, important insights on clinical features and benefits, and adverse effects. These agents represent a fundamentally different way of controlling blood glucose and for the first time in T2DM care to offer the opportunity to reduce glucose, blood pressure, and weight with effects sustained for at least 2 years. Important side effects include genital mycotic infections and the potential for orthostatic hypotension and rare instances of normoglycemic ketoacidosis. Active ongoing clinical trials promise to deepen our experience with the potential benefits, as well as the clinical risks attending the use of this new group of antidiabetic agents. PMID:28255241

Nursing students' perspectives on clinical instructors' effective teaching strategies: A descriptive study.

PubMed

Valiee, Sina; Moridi, Glorokh; Khaledi, Shahnaz; Garibi, Fardin

2016-01-01

An important factor contributing to the quality of clinical education is instructors' teaching performance. The aim of this study was to identify clinical instructors' most effective teaching strategies from nursing and midwifery students' perspectives. This was a descriptive cross-sectional study. All third- and fourth-year bachelor's nursing and midwifery students studying at the Nursing and Midwifery Faculty of Kurdistan University of Medical Sciences were recruited to the study by using the census method. The study instrument consisted of a demographic questionnaire and the self-report 30-item Clinical Instructors' Effective Teaching Strategies Inventory. The SPSS v.16.0 was used for data analysis. The most effective teaching strategies of clinical instructors from nursing and midwifery students' perspectives were respectively 'treating students, clients, and colleagues with respect' and 'being eager for guiding students and manage their problems'. Clinical instructors need to be eager for education and also be able to establish effective communication with students. Empowering clinical instructors in specialized and technical aspects of clinical education seems necessary. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Need for Data-Informed Clinical Supervision in Substance Use Disorder Treatment

PubMed Central

Ramsey, Alex T.; Baumann, Ana; Silver Wolf, David Patterson; Yan, Yan; Cooper, Ben; Proctor, Enola

2017-01-01

Background Effective clinical supervision is necessary for high-quality care in community-based substance use disorder treatment settings, yet little is known about current supervision practices. Some evidence suggests that supervisors and counselors differ in their experiences of clinical supervision; however, the impact of this misalignment on supervision quality is unclear. Clinical information monitoring systems may support supervision in substance use disorder treatment, but the potential use of these tools must first be explored. Aims First, this study examines the extent to which misaligned supervisor-counselor perceptions impact supervision satisfaction and emphasis on evidence-based treatments. This study also reports on formative work to develop a supervision-based clinical dashboard, an electronic information monitoring system and data visualization tool providing real-time clinical information to engage supervisors and counselors in a coordinated and data-informed manner, help align supervisor-counselor perceptions about supervision, and improve supervision effectiveness. Methods Clinical supervisors and frontline counselors (N=165) from five Midwestern agencies providing substance abuse services completed an online survey using Research Electronic Data Capture (REDCap) software, yielding a 75% response rate. Valid quantitative measures of supervision effectiveness were assessed, along with qualitative perceptions of a supervision-based clinical dashboard. Results Through within-dyad analyses, misalignment between supervisor and counselor perceptions of supervision practices was negatively associated with satisfaction of supervision and reported frequency of discussing several important clinical supervision topics, including evidence-based treatments and client rapport. Participants indicated the most useful clinical dashboard functions and reported important benefits and challenges to using the proposed tool. Discussion Clinical supervision tends to be largely an informal and unstructured process in substance abuse treatment, which may compromise the quality of care. Clinical dashboards may be a well-targeted approach to facilitate data-informed clinical supervision in community-based treatment agencies. PMID:28166480

The need for data-informed clinical supervision in substance use disorder treatment.

PubMed

Ramsey, Alex T; Baumann, Ana; Patterson Silver Wolf, David; Yan, Yan; Cooper, Ben; Proctor, Enola

2017-01-01

Effective clinical supervision is necessary for high-quality care in community-based substance use disorder treatment settings, yet little is known about current supervision practices. Some evidence suggests that supervisors and counselors differ in their experiences of clinical supervision; however, the impact of this misalignment on supervision quality is unclear. Clinical information monitoring systems may support supervision in substance use disorder treatment, but the potential use of these tools must first be explored. First, the current study examines the extent to which misaligned supervisor-counselor perceptions impact supervision satisfaction and emphasis on evidence-based treatments. This study also reports on formative work to develop a supervision-based clinical dashboard, an electronic information monitoring system and data visualization tool providing real-time clinical information to engage supervisors and counselors in a coordinated and data-informed manner, help align supervisor-counselor perceptions about supervision, and improve supervision effectiveness. Clinical supervisors and frontline counselors (N = 165) from five Midwestern agencies providing substance abuse services completed an online survey using Research Electronic Data Capture software, yielding a 75% response rate. Valid quantitative measures of supervision effectiveness were administered, along with qualitative perceptions of a supervision-based clinical dashboard. Through within-dyad analyses, misalignment between supervisor and counselor perceptions of supervision practices was negatively associated with satisfaction of supervision and reported frequency of discussing several important clinical supervision topics, including evidence-based treatments and client rapport. Participants indicated the most useful clinical dashboard functions and reported important benefits and challenges to using the proposed tool. Clinical supervision tends to be largely an informal and unstructured process in substance abuse treatment, which may compromise the quality of care. Clinical dashboards may be a well-targeted approach to facilitate data-informed clinical supervision in community-based treatment agencies.

Clinical supervision for nurses in administrative and leadership positions: a systematic literature review of the studies focusing on administrative clinical supervision.

PubMed

Sirola-Karvinen, Pirjo; Hyrkäs, Kristiina

2006-11-01

The aim of this systematic literature review was to describe administrative clinical supervision from the nursing leaders', directors' and administrators' perspective. Administrative clinical supervision is a timely and important topic as organizational structures in health care and nursing leadership are changing in addition to the increasing number of complex challenges present in health care. The material in this review was drawn from national and international databases including doctoral dissertations, distinguished thesis and peer-reviewed articles. The material was analysed by means of content analysis. The theoretical framework for the analysis was based on the three main functions of clinical supervision: administrative, educational and supportive. The findings demonstrated that the experiences of the administrative clinical supervision and its supportiveness were varying. The intervention was seen to provide versatility of learning experiences and support in challenging work experiences. Administrative clinical supervision effects and assures the quality of care. The effects as a means of development were explained through its resemblance to a leading specialist community. The findings support earlier perceptions concerning the importance and significance of administrative clinical supervision for nursing managers and administrators. However, more research is needed to develop administrative clinical supervision and to increase understanding of theoretical assumptions and relationships of the concepts on the background.

Understanding health economic analysis in critical care: insights from recent randomized controlled trials.

PubMed

Sud, Sachin; Cuthbertson, Brian H

2011-10-01

The article reviews the methods of health economic analysis (HEA) in clinical trials of critically ill patients. Emphasis is placed on the usefulness of HEA in the context of positive and 'no effect' studies, with recent examples. The need to control costs and promote effective spending in caring for the critically ill has garnered considerable attention due to the high cost of critical illness. Many clinical trials focus on short-term mortality, ignoring costs and quality of life, and fail to change clinical practice or promote efficient use of resources. Incorporating HEA into clinical trials is a possible solution. Such studies have shown some interventions, although expensive, provide good value, whereas others should be withdrawn from clinical practice. Incorporating HEA into randomized controlled trials (RCTs) requires careful attention to collect all relevant costs. Decision trees, modeling assumptions and methods for collecting costs and measuring outcomes should be planned and published beforehand to minimize bias. Costs and cost-effectiveness are potentially useful outcomes in RCTs of critically ill patients. Future RCTs should incorporate parallel HEA to provide both economic outcomes, which are important to the community, alongside patient-centered outcomes, which are important to individuals.

Clinical trials in predementia stages of Alzheimer disease.

PubMed

Pillai, Jagan A; Cummings, Jeffrey L

2013-05-01

Effective treatments of Alzheimer disease (AD) dementia are an urgent necessity. There is a growing consensus that effective disease-modifying treatment before the onset of clinical dementia and slowing the progression of mild symptoms are needed after recent setbacks in AD therapeutics. The identification of at-risk and preclinical AD populations is becoming important for targeting primary and secondary prevention clinical trials in AD. This article reviews the strategies and challenges in targeting at-risk and preclinical AD populations for a new generation of AD clinical trials. Design, outcome measures, and complexities in successfully completing a clinical trial targeting this population are reviewed. Copyright © 2013 Elsevier Inc. All rights reserved.

[Application of three compartment model and response surface model to clinical anesthesia using Microsoft Excel].

PubMed

Abe, Eiji; Abe, Mari

2011-08-01

With the spread of total intravenous anesthesia, clinical pharmacology has become more important. We report Microsoft Excel file applying three compartment model and response surface model to clinical anesthesia. On the Microsoft Excel sheet, propofol, remifentanil and fentanyl effect-site concentrations are predicted (three compartment model), and probabilities of no response to prodding, shaking, surrogates of painful stimuli and laryngoscopy are calculated using predicted effect-site drug concentration. Time-dependent changes in these calculated values are shown graphically. Recent development in anesthetic drug interaction studies are remarkable, and its application to clinical anesthesia with this Excel file is simple and helpful for clinical anesthesia.

Simulation stimulates learning in a childbearing clinical course.

PubMed

Simonelli, Mary Colleen; Paskausky, Anna L

2012-03-01

Preparing nursing students to become integral members of today's health care team presents educators with unique challenges in both classroom and clinical settings. This study examined the effectiveness of adding high-fidelity simulation to a childbearing clinical course. Our systematic research addressed the importance of evaluating the outcomes of using simulation on both knowledge acquisition and clinical competency. We found simulation to have a positive effect on not only student clinical performance, but also knowledge development in the undergraduate child-bearing clinical course. These outcome data will inform the curriculum changes needed as we strive to facilitate student proficiency in clinical concepts and skills and prepare the next generation of nurses entering our increasingly complex health care system. Copyright 2012, SLACK Incorporated.

Intentional Modelling: A Process for Clinical Leadership Development in Mental Health Nursing.

PubMed

Ennis, Gary; Happell, Brenda; Reid-Searl, Kerry

2016-05-01

Clinical leadership is becoming more relevant for nurses, as the positive impact that it can have on the quality of care and outcomes for consumers is better understood and more clearly articulated in the literature. As clinical leadership continues to become more relevant, the need to gain an understanding of how clinical leaders in nursing develop will become increasingly important. While the attributes associated with effective clinical leadership are recognized in current literature there remains a paucity of research on how clinical leaders develop these attributes. This study utilized a grounded theory methodology to generate new insights into the experiences of peer identified clinical leaders in mental health nursing and the process of developing clinical leadership skills. Participants in this study were nurses working in a mental health setting who were identified as clinical leaders by their peers as opposed to identifying them by their role or organizational position. A process of intentional modeling emerged as the substantive theory identified in this study. Intentional modeling was described by participants in this study as a process that enabled them to purposefully identify models that assisted them in developing the characteristics of effective clinical leaders as well as allowing them to model these characteristics to others. Reflection on practice is an important contributor to intentional modelling. Intentional modelling could be developed as a framework for promoting knowledge and skill development in the area of clinical leadership.

Integrating fluoroquinolones into the hospital formulary.

PubMed

Bertino, J S

2001-10-01

With the increasing availability of new agents, selection of fluoroquinolones for formulary inclusion can be difficult. Appropriate evaluation of the important characteristics (pharmacokinetic and pharmacodynamic properties, antimicrobial activity, efficacy, tolerability, cost) of these agents should allow selection of the most cost-effective ones. Evidence from in vitro studies and clinical trials indicates differences exist among fluoroquinolones, especially in terms of activity against gram-positive, aerobic organisms. For selected clinical situations, it may be important to choose an agent that is available in both intravenous and oral formulations. Comparative drug costs, as well as costs associated with potential clinical failure and adverse events, should be evaluated carefully. Dosage regimens should be considered, as shorter durations of therapy and less frequent dose administration may lead to reduced labor costs and increased patient compliance, thereby improving effectiveness and economic efficiency.

Work-engaged nurses for a better clinical learning environment: a ward-level analysis.

PubMed

Tomietto, Marco; Comparcini, Dania; Simonetti, Valentina; Pelusi, Gilda; Troiani, Silvano; Saarikoski, Mikko; Cicolini, Giancarlo

2016-05-01

To correlate workgroup engagement in nursing teams and the clinical learning experience of nursing students. Work engagement plays a pivotal role in explaining motivational dynamics. Nursing education is workplace-based and, through their clinical placements, nursing students develop both their clinical competences and their professional identity. However, there is currently a lack of evidence on the role of work engagement related to students' learning experiences. A total of 519 nurses and 519 nursing students were enrolled in hospital settings. The Utrecht Work Engagement Scale (UWES) was used to assess work engagement, and the Clinical Learning Environment and Supervision plus nurse Teacher (CLES+T) scale was used to assess students' learning experience. A multilevel linear regression analysis was performed. Group-level work engagement of nurses correlated with students' clinical learning experience (β = 0.11, P < 0.001). Specifically, the 'absorption' and 'dedication' factors mostly contributed to enhancing clinical learning (respectively, β = 0.37, P < 0.001 and β = 0.20, P < 0.001). Nursing teams' work engagement is an important motivational factor to enhance effective nursing education. Nursing education institutions and health-care settings need to conjointly work to build effective organisational climates. The results highlighted the importance of considering the group-level analysis to understand the most effective strategies of intervention for both organisations and nursing education. © 2015 John Wiley & Sons Ltd.

The factors facilitating and inhibiting effective clinical decision-making in nursing: a qualitative study

PubMed Central

Hagbaghery, Mohsen Adib; Salsali, Mahvash; Ahmadi, Fazlolah

2004-01-01

Background Nurses' practice takes place in a context of ongoing advances in research and technology. The dynamic and uncertain nature of health care environment requires nurses to be competent decision-makers in order to respond to clients' needs. Recently, the public and the government have criticized Iranian nurses because of poor quality of patient care. However nurses' views and experiences on factors that affect their clinical function and clinical decision-making have rarely been studied. Methods Grounded theory methodology was used to analyze the participants' lived experiences and their viewpoints regarding the factors affecting their clinical function and clinical decision-making. Semi-structured interviews and participant observation methods were used to gather the data. Thirty-eight participants were interviewed and twelve sessions of observation were carried out. Constant comparative analysis method was used to analyze the data. Results Five main themes emerged from the data. From the participants' points of view, "feeling competent", "being self-confident", "organizational structure", "nursing education", and "being supported" were considered as important factors in effective clinical decision-making. Conclusion As participants in this research implied, being competent and self-confident are the most important personal factors influencing nurses clinical decision-making. Also external factors such as organizational structure, access to supportive resources and nursing education have strengthening or inhibiting effects on the nurses' decisions. Individual nurses, professional associations, schools of nursing, nurse educators, organizations that employ nurses and government all have responsibility for developing and finding strategies that facilitate nurses' effective clinical decision-making. They are responsible for identifying barriers and enhancing factors within the organizational structure that facilitate nurses' clinical decision-making. PMID:15068484

Examining Curricular Integration Strategies To Optimize Learning Of The Anatomical Sciences

NASA Astrophysics Data System (ADS)

Lisk, Kristina Adriana Ayako

Background: Integration of basic and clinical science knowledge is essential to clinical practice. Although the importance of these two knowledge domains is well-recognized, successfully supporting the development of learners' integrated basic and clinical science knowledge, remains an educational challenge. In this dissertation, I examine curricular integration strategies to optimize learning of the anatomical sciences. Objectives: The studies were designed to achieve the following research aims: 1) to objectively identify clinically relevant content for an integrated musculoskeletal anatomy curriculum; 2) to examine the value of integrated anatomy and clinical science instruction compared to clinical science instruction alone on novices' diagnostic accuracy and diagnostic reasoning process; 3) to compare the effect of integrating and segregating anatomy and clinical science instruction along with a learning strategy (self-explanation) on novices' diagnostic accuracy. Methods: A modified Delphi was used to objectively select clinically relevant content for an integrated musculoskeletal anatomy curriculum. Two experimental studies were created to compare different instructional strategies to optimize learning of the curricular content. In both of these studies, novice learners were taught the clinical features of musculoskeletal pathologies using different learning approaches. Diagnostic performance was measured immediately after instruction and one-week later. Results: The results show that the Delphi method is an effective strategy to select clinically relevant content for integrated anatomy curricula. The findings also demonstrate that novices who were explicitly taught the clinical features of musculoskeletal diseases using causal basic science descriptions had superior diagnostic accuracy and a better understanding of the relative importance of key clinical features for disease categories. Conclusions: This research demonstrates how integration strategies can be applied at multiple levels of the curriculum. Further, this work shows the value of cognitive integration of anatomy and clinical science and it emphasizes the importance of purposefully linking the anatomical and clinical sciences in day-to-day teaching.

The evolution of spinal/epidural neostigmine in clinical application: Thoughts after two decades

PubMed Central

Lauretti, Gabriela Rocha

2015-01-01

Since the first clinical application of analgesia following spinal anticholinesterase by 1940's, several clinical double-blind studies have been conducted to date, where intrathecal doses of neostigmine in humans ranged from 750 to 1 μg, due to side-effects. Conversely, epidural neostigmine has been evaluated in proportionally higher doses and represents an alternative, but still deserves more investigation concerning both acute and chronic pain, as it seems devoid of important side-effects. PMID:25558203

RESPONSIVENESS OF THE ACTIVITIES OF DAILY LIVING SCALE OF THE KNEE OUTCOME SURVEY AND NUMERIC PAIN RATING SCALE IN PATIENTS WITH PATELLOFEMORAL PAIN

PubMed Central

Piva, Sara R.; Gil, Alexandra B.; Moore, Charity G.; Fitzgerald, G. Kelley

2016-01-01

Objective To assess internal and external responsiveness of the Activity of Daily Living Scale of the Knee Outcome Survey and Numeric Pain Rating Scale on patients with patellofemoral pain. Design One group pre-post design. Subjects A total of 60 individuals with patellofemoral pain (33 women; mean age 29.9 (standard deviation 9.6) years). Methods The Activity of Daily Living Scale and the Numeric Pain Rating Scale were assessed before and after 8 weeks of physical therapy program. Patients completed a global rating of change scale at the end of therapy. The standardized effect size, Guyatt responsiveness index, and the minimum clinical important difference were calculated. Results Standardized effect size of the Activity of Daily Living Scale was 0.63, Guyatt responsiveness index was 1.4, area under the curve was 0.83 (95% confidence interval: 0.72, 0.94), and the minimum clinical important difference corresponded to an increase of 7.1 percentile points. Standardized effect size of the Numeric Pain Rating Scale was 0.72, Guyatt responsiveness index was 2.2, area under the curve was 0.80 (95% confidence interval: 0.70, 0.92), and the minimum clinical important difference corresponded to a decrease of 1.16 points. Conclusion Information from this study may be helpful to therapists when evaluating the effectiveness of rehabilitation intervention on physical function and pain, and to power future clinical trials on patients with patellofemoral pain. PMID:19229444

Responsiveness of the activities of daily living scale of the knee outcome survey and numeric pain rating scale in patients with patellofemoral pain.

PubMed

Piva, Sara R; Gil, Alexandra B; Moore, Charity G; Fitzgerald, G Kelley

2009-02-01

To assess internal and external responsiveness of the Activity of Daily Living Scale of the Knee Outcome Survey and Numeric Pain Rating Scale on patients with patellofemoral pain. One group pre-post design. A total of 60 individuals with patellofemoral pain (33 women; mean age 29.9 (standard deviation 9.6) years). The Activity of Daily Living Scale and the Numeric Pain Rating Scale were assessed before and after 8 weeks of physical therapy program. Patients completed a global rating of change scale at the end of therapy. The standardized effect size, Guyatt responsiveness index, and the minimum clinical important difference were calculated. Standardized effect size of the Activity of Daily Living Scale was 0.63, Guyatt responsiveness index was 1.4, area under the curve was 0.83 (95% confidence interval: 0.72, 0.94), and the minimum clinical important difference corresponded to an increase of 7.1 percentile points. Standardized effect size of the Numeric Pain Rating Scale was 0.72, Guyatt responsiveness index was 2.2, area under the curve was 0.80 (95% confidence interval: 0.70, 0.92), and the minimum clinical important difference corresponded to a decrease of 1.16 points. Information from this study may be helpful to therapists when evaluating the effectiveness of rehabilitation intervention on physical function and pain, and to power future clinical trials on patients with patellofemoral pain.

Comparative effectiveness research in clinical practice.

PubMed

Lawrence, William F; Chang, Stephanie; Kane, Robert L; Wilt, Timothy J

2014-08-01

The Agency for Healthcare Research and Quality (AHRQ) has funded systematic reviews of comparative effectiveness research in 17 areas over the last 10 years as part of a federal mandate. These reviews provide a reliable and unbiased source of comprehensive information about the effectiveness and risks of treatment alternatives for patients and clinicians. This article describes comparative effectiveness research, provides an overview of how physicians can use it in clinical practice, and references important contributions made by the Minnesota Evidence-based Practice Center.

Rational decision-making in mental health: the role of systematic reviews.

PubMed

Gilbody, Simon M.; Petticrew, Mark

1999-09-01

BACKGROUND: "Systematic reviews" have come to be recognized as the most rigorous method of summarizing confusing and often contradictory primary research in a transparent and reproducible manner. Their greatest impact has been in the summarization of epidemiological literature - particularly that relating to clinical effectiveness. Systematic reviews also have a potential to inform rational decision-making in healthcare policy and to form a component of economic evaluation. AIMS OF THE STUDY: This article aims to introduce the rationale behind systematic reviews and, using examples from mental health, to introduce the strengths and limitations of systematic reviews, particularly in informing mental health policy and economic evaluation. METHODS: Examples are selected from recent controversies surrounding the introduction of new psychiatric drugs (anti-depressants and anti-schizophrenia drugs) and methods of delivering psychiatric care in the community (case management and assertive community treatment). The potential for systematic reviews to (i) produce best estimates of clinical efficacy and effectiveness, (ii) aid economic evaluation and policy decision-making and (iii) highlight gaps in the primary research knowledge base are discussed. Lastly examples are selected from outside mental health to show how systematic reviews have a potential to be explicitly used in economic and health policy evaluation. RESULTS: Systematic reviews produce the best estimates of clinical efficacy, which can form an important component of economic evaluation. Importantly, serious methodological flaws and areas of uncertainty in the primary research literature are identified within an explicit framework. Summary indices of clinical effectiveness can be produced, but it is difficult to produce such summary indices of cost effectiveness by pooling economic data from primary studies. Modelling is commonly used in economic and policy evaluation. Here, systematic reviews can provide the best estimates of effectiveness and, importantly, highlight areas of uncertainty that can be used in "sensitivity analysis". DISCUSSION: Systematic reviews are an important recent methodological advance, the potential for which has only begun to be realized in mental health. This use of systematic reviews is probably most advanced in producing critical summaries of clinical effectiveness data. Systematic reviews cannot produce valid and believable conclusions when the primary research literature is of poor quality. An important function of systematic reviews will be in highlighting this poor quality research which is of little use in mental health decision making. IMPLICATIONS FOR HEALTH PROVISION: Health care provision should be both clinically and cost effective. Systematic reviews are a key component in ensuring that this goal is achieved. IMPLICATIONS FOR HEALTH POLICIES: Systematic reviews have potential to inform health policy. Examples presented show that health policy is often made without due consideration of the research evidence. Systematic reviews can provide robust and believable answers, which can help inform rational decision-making. Importantly, systematic reviews can highlight the need for important primary research and can inform the design of this research such that it provides answers that will help in forming healthcare policy. IMPLICATIONS FOR FURTHER RESEARCH: Systematic reviews should precede costly (and often unnecessary) primary research. Many areas of health policy and practice have yet to be evaluated using systematic review methodology. Methods for the summarization of economic data are methodologically complex and deserve further research

Clinical perspective: creating an effective practice peer review process-a primer.

PubMed

Gandhi, Manisha; Louis, Frances S; Wilson, Shae H; Clark, Steven L

2017-03-01

Peer review serves as an important adjunct to other hospital quality and safety programs. Despite its importance, the available literature contains virtually no guidance regarding the structure and function of effective peer review committees. This Clinical Perspective provides a summary of the purposes, structure, and functioning of effective peer review committees. We also discuss important legal considerations that are a necessary component of such processes. This discussion includes useful templates for case selection and review. Proper committee structure, membership, work flow, and leadership as well as close cooperation with the hospital medical executive committee and legal representatives are essential to any effective peer review process. A thoughtful, fair, systematic, and organized approach to creating a peer review process will lead to confidence in the committee by providers, hospital leadership, and patients. If properly constructed, such committees may also assist in monitoring and enforcing compliance with departmental protocols, thus reducing harm and promoting high-quality practice. Copyright © 2016 Elsevier Inc. All rights reserved.

Minimal clinically important difference in the fibromyalgia impact questionnaire.

PubMed

Bennett, Robert M; Bushmakin, Andrew G; Cappelleri, Joseph C; Zlateva, Gergana; Sadosky, Alesia B

2009-06-01

The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, >or= 39 to <59 a moderate effect, and >or=59 to 100 a severe effect. The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice.

Challenges Evaluating Chemotherapy-Induced Peripheral Neuropathy in Childhood Cancer Survivors.

PubMed

Mohrmann, Caroline; Armer, Jane; Hayashi, Robert J

Children treated for cancer are exposed to a variety of chemotherapeutic agents with known toxicity to the peripheral nervous system. The side effect of peripheral neuropathy can cause changes in sensation, function, and even cause pain. Although peripheral neuropathy is recognized by pediatric oncology nurses as an important and significant side effect, measuring neuropathy can be quite complex for clinical care and research efforts. With more children surviving a cancer diagnosis today, this issue is increasingly important for childhood cancer survivors. This article has reviewed existing literature examining peripheral neuropathy in childhood cancer survivors with particular interest paid to measurement tools available and needs for future research. It is important for nurses to choose appropriate measures for clinical care and research methods in order to have an impact on patients experiencing this condition.

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

PubMed Central

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

2015-01-01

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

Effectiveness of low-dose pasireotide in a patient with Cushing's disease: antiproliferative effect and predictivity of a short pasireotide suppression test.

PubMed

Grossrubatscher, Erika; Zampetti, Benedetta; Dalino Ciaramella, Paolo; Doneda, Paola; Loli, Paola

2015-08-01

This case shows efficacy of low-dose pasireotide in biochemical and clinical control of severe hypercortisolism and in tumor volume reduction in a patient with an ACTH-secreting macroadenoma. The drug may be an option for long-term treatment in some patients where control of tumor mass is an important clinical endpoint.

The effectiveness of clinical supervision for a group of ward managers based in a district general hospital: an evaluative study.

PubMed

Davis, Cynthia; Burke, Linda

2012-09-01

To present an evaluative audit assessing the effectiveness of clinical supervision for ward managers. A year-long project to introduce clinical supervision to ward managers was implemented and evaluated. The objectives were to evaluate staff perceptions of implementing clinical supervision and determine its outcomes. An audit evaluation process was used. Findings are presented against perceptions, implementation and reported outcomes of clinical supervision. Insights were gained into its relevance and importance to nurses and the organisation. Findings show that clinical supervision was perceived to be effective and helped improve patient care, but some feared it becoming a form of managerial control. Ward managers perceived advantages for personal and professional development from adopting this process. There is a need for greater understanding of clinical supervision before Trusts implement it. The introduction of a resource pack for clinical areas would also be of value. Finally, there needs to be a named person who has a special knowledge of clinical supervision to act as a champion and change agent in effecting implementation at both the executive level and within each clinical area. © 2011 Blackwell Publishing Ltd.

The Role of Clinical Pharmacists in Educating Nurses to Reduce Drug-Food Interactions (Absorption Phase) in Hospitalized Patients

PubMed Central

Abbasi Nazari, Mohammad; Salamzadeh, Jamshid; Hajebi, Giti; Gilbert, Benjamin

2011-01-01

Drug-food interactions can increase or decrease drug effects, resulting in therapeutic failure or toxicity. Activities that reduce these interactions play an important role for clinical pharmacists. This study was planned and performed in order to determine the role of clinical pharmacist in the prevention of absorption drug-food interactions through educating the nurses in a teaching hospital affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran. The rate of interactions was determined using direct observation methods before and after the nurse training courses in four wards including gastrointestinal-liver, endocrine, vascular surgery and nephrology. Training courses consisted of the nurse attendance lecture delivered by a clinical pharmacist which included receiving information pamphlets. Total incorrect drug administration fell down from 44.6% to 31.5%. The analysis showed that the rate of absorption drug-food interactions significantly decreased after the nurse training courses (p < 0.001). Clinical pharmacist can play an important role in nurse training as an effective method to reduce drug-food interactions in hospitals. PMID:24363698

Developing an evidence-based practice protocol: implications for midwifery practice.

PubMed

Carr, K C

2000-01-01

Evidence-based practice is defined and its importance to midwifery practice is presented. Guidelines are provided for the development of an evidence-based practice protocol. These include: identifying the clinical question, obtaining the evidence, evaluating the validity and importance of the evidence, synthesizing the evidence and applying it to the development of a protocol or clinical algorithm, and, finally, developing an evaluation plan or measurement strategy to see if the new protocol is effective.

How clinical communication has become a core part of medical education in the UK.

PubMed

Brown, Jo

2008-03-01

This paper sets out to analyse and interpret the complex events of the last 20 years in order to understand how the teaching and learning of clinical communication has emerged as a core part of the modern undergraduate medical curriculum in most medical schools in the UK. The paper analyses the effects of key political, sociological, historical and policy influences on clinical communication development. Political influences include: the effects of neo-liberalism on society and on the professions in general; the challenging of traditional notions of professionalism in medicine; the creation of an internal market within the National Health Service, and the disempowerment of the medical lobby. Sociological influences include: the effects of a 'marketised' society on medicine and subtle shifts in the doctor-patient relationship because of this; the emergence of globalised information through the Internet, and the influence of increased litigation against doctors. Historical influences include: the effects of a change in emphasis for medical education away from an inflated factual curriculum towards a curriculum that recognises the importance of student attitudes and the teaching and learning of clinical communication skills. Policy influences include the important effects of Tomorrow's Doctors and the Dearing Report on the modern medical curriculum. The paper concludes with a developmental map that charts the complex influences on clinical communication teaching and learning and a brief commentary on the growing body of teachers who deliver and develop the subject today.

Clinical evaluation of patients with patellofemoral disorders.

PubMed

Post, W R

1999-01-01

Accurate clinical evaluation of patients with patellofemoral disorders is the cornerstone of effective treatment. This article defines how a careful history and physical examination can direct strategies for nonoperative and operative management. A critical analysis of traditional methods of evaluation and a streamlined rational approach to clinical evaluation is presented. Key questions and important physical findings that affect treatment decisions are emphasized.

Where are the history and the physical?

PubMed Central

Bordage, G

1995-01-01

In clinical practice, the history and physical examination are being superseded by laboratory tests and biomedical technology. The author discusses the importance of the clinical examination as the basis for clinical reasoning and of direct observation of students at the patients' bedside in order to assess their diagnostic reasoning. Greater attention to the clinical examination would lead not only to improved clinical skills but also to more cost-effective use of ancillary investigations and, moreover, to a better understanding of the patient by the physician. PMID:7743445

Climate Change Effects on Respiratory Health: Implications for Nursing.

PubMed

George, Maureen; Bruzzese, Jean-Marie; Matura, Lea Ann

2017-11-01

Greenhouse gases are driving climate change. This article explores the adverse health effects of climate change on a particularly vulnerable population: children and adults with respiratory conditions. This review provides a general overview of the effects of increasing temperatures, extreme weather, desertification, and flooding on asthma, chronic obstructive lung disease, and respiratory infections. We offer suggestions for future research to better understand climate change hazards, policies to support prevention and mitigation efforts targeting climate change, and clinical actions to reduce individual risk. Climate change produces a number of changes to the natural and built environments that may potentially increase respiratory disease prevalence, morbidity, and mortality. Nurses might consider focusing their research efforts on reducing the effects of greenhouse gases and in directing policy to mitigate the harmful effects of climate change. Nurses can also continue to direct educational and clinical actions to reduce risks for all populations, but most importantly, for our most vulnerable groups. While advancements have been made in understanding the impact of climate change on respiratory health, nurses can play an important role in reducing the deleterious effects of climate change. This will require a multipronged approach of research, policy, and clinical action. © 2017 Sigma Theta Tau International.

Lymphatic filariasis: patients and the global elimination programme.

PubMed

Mackenzie, C D; Lazarus, W M; Mwakitalu, M E; Mwingira, U; Malecela, M N

2009-10-01

The defining images of lymphatic filariasis are the horrendous disfigurements of lymphoedema, elephantiasis and hydrocele. These clinical presentations, although obviously important and life changing, are not, however, the only outcomes of this wide-spread filarial infection. The other effects of the disease range from severe, acute but short-term bouts of sickness to psychological impairment, poverty and family hardship. It is important to support cases of the disease through all means available, such as reparative hydrocelectomy, hygiene training and facilitation, and the provision of adequate chemotherapy. Although only a minority of the residents in any endemic community is affected with the severe clinical manifestations of this parasitic infection, these cases are central to, and important advocates for, the current global effort to eliminate the infection through mass drug administrations (MDA). Their clinical improvement acts as an important catalyst for the general population and encourages high compliance in the MDA. This communication discusses the central role that filariasis patients have played in the Tanzania Lymphatic Filariasis Elimination Programme to date, and covers some of the clinical successes achieved in the past 10 years. The abolition of the clinical manifestations of filarial infection remains the ultimate goal of the Global Programme to Eliminate Lymphatic Filariasis, and maintaining a focus on the affected individuals and their clinical condition is vital to that programme's overall success.

Is Religiosity Related to Attitudes Towards Clinical Trials Participation?

PubMed Central

Daverio-Zanetti, Svetlana; Schultz, Kathryn; del Campo, Miguel A. Martin; Malcarne, Vanessa; Riley, Natasha; Sadler, Georgia Robins

2014-01-01

Research indicates that a low percentage of cancer patients enroll in cancer clinical trials. This is especially true among minority groups such as Hispanic Americans. Considering the importance of religion in the Hispanic American community, it is important to understand its relationship to perceptions of clinical trials. Five hundred and three Latina women completed the Barriers to Clinical Trials Participation Scale and the Duke University Religion Index. For the total sample, higher organizational and intrinsic religiosity were significantly associated with perceived lack of community support for clinical trials participation. In subgroup analysis, the relationship between organizational religiosity and lack of support was stronger among Latinas who were Spanish language-preference, and Latinas who were Catholic. Intrinsic religiosity was associated with mistrust among Spanish language-preference Latinas, and both organizational and intrinsic religiosity were associated with lack of familiarity with clinical trials among Christian (non-Catholic) Latinas. These results indicate religious institutions that serve Latinas may be an effective venue for disseminating clinical trial education programs to improve attitudes toward clinical trials participation. PMID:24953236

Minimum Clinically Important Difference and Substantial Clinical Benefit in Pain, Functional, and Quality of Life Scales in Failed Back Surgery Syndrome Patients.

PubMed

Park, Ki Byung; Shin, Joon-Shik; Lee, Jinho; Lee, Yoon Jae; Kim, Me-Riong; Lee, Jun-Hwan; Shin, Kyung-Min; Shin, Byung-Cheul; Cho, Jae-Heung; Ha, In-Hyuk

2017-04-15

.: Prospective observational 1-year study. .: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient. .: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined. .: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach. .: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively. .: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients. 3.

[Discussion on six errors of formulas corresponding to syndromes in using the classic formulas].

PubMed

Bao, Yan-ju; Hua, Bao-jin

2012-12-01

The theory of formulas corresponding to syndromes is one of the characteristics of Treatise on Cold Damage and Miscellaneous Diseases (Shanghan Zabing Lun) and one of the main principles in applying classic prescriptions. It is important to take effect by following the principle of formulas corresponding to syndromes. However, some medical practitioners always feel that the actual clinical effect is far less than expected. Six errors in the use of classic prescriptions as well as the theory of formulas corresponding to syndromes are the most important causes to be considered, i.e. paying attention only to the local syndromes while neglecting the whole, paying attention only to formulas corresponding to syndromes while neglecting the pathogenesis, paying attention only to syndromes while neglecting the pulse diagnosis, paying attention only to unilateral prescription but neglecting the combined prescriptions, paying attention only to classic prescriptions while neglecting the modern formulas, and paying attention only to the formulas but neglecting the drug dosage. Therefore, not only the patients' clinical syndromes, but also the combination of main syndrome and pathogenesis simultaneously is necessary in the clinical applications of classic prescriptions and the theory of prescription corresponding to syndrome. In addition, comprehensive syndrome differentiation, modern formulas, current prescriptions, combined prescriptions, and drug dosage all contribute to avoid clinical errors and improve clinical effects.

Barriers to Practical Learning in the Field: A Qualitative Study of Iranian Nursing Students' Experiences.

PubMed

Jahanpour, Faezeh; Azodi, Parviz; Azodi, Farzan; Khansir, Ali Akbar

2016-06-01

Clinical training is an integral part of nursing education; however, some studies have shown that it is not always efficient. This study aimed to find out the factors that can impede nursing students' clinical learning. In this qualitative study, data were collected via reflective journal writing. Purposeful sampling was used, and 12 senior nursing students were recruited to the study. The data were analyzed using a content analysis method. Three main categories were derived, including inappropriate communication, ineffective role models, and theory-practice gaps. Students perceived that inappropriate communication between instructors, staff members, and students had the greatest impact on student learning. The competence of clinical instructors and staff is an important factor affecting students' training. The clinical learning environment does not always integrate theory and practice together. Nursing students did not experience effective clinical learning. Having expert instructors and supportive communication are important factors in creating a clinical learning environment.

Establishing a successful clinical research program.

PubMed

Scoglio, Daniele; Fichera, Alessandro

2014-06-01

Clinical research (CR) is a natural corollary to clinical surgery. It gives an investigator the opportunity to critically review their results and develop new strategies. This article covers the critical factors and the important components of a successful CR program. The first and most important step is to build a dedicated research team to overcome time constraints and enable a surgical practice to make CR a priority. With the research team in place, the next step is to create a program on the basis of an original idea and new clinical hypotheses. This often comes from personal experience supported by a review of the available evidence. Randomized controlled (clinical) trials are the most stringent way of determining whether a cause-effect relationship exists between the intervention and the outcome. In the proper setting, translational research may offer additional avenues allowing clinical application of basic science discoveries.

Clinical decision support: effectiveness in improving quality processes and clinical outcomes and factors that may influence success.

PubMed

Murphy, Elizabeth V

2014-06-01

The use of electronic health records has skyrocketed following the 2009 HITECH Act, which provides financial incentives to health care providers for the "meaningful use" of electronic medical record systems. An important component of the "Meaningful Use" legislation is the integration of Clinical Decision Support Systems (CDSS) into the computerized record, providing up-to-date medical knowledge and evidence-based guidance to the physician at the point of care. As reimbursement is increasingly tied to process and clinical outcomes, CDSS will be integral to future medical practice. Studies of CDSS indicate improvement in preventive services, appropriate care, and clinical and cost outcomes with strong evidence for CDSS effectiveness in process measures. Increasing provider adherence to CDSS recommendations is essential in improving CDSS effectiveness, and factors that influence adherence are currently under study.

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

PubMed

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

2014-10-01

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

The heart and potassium: a banana republic.

PubMed

Khan, Ehsan; Spiers, Christine; Khan, Maria

2013-03-01

The importance of potassium in maintaining stable cardiac function is a clinically understood phenomenon. Physiologically the importance of potassium in cardiac function is described by the large number of different kinds of potassium ions channels found in the heart compared to channels and membrane transport mechanisms for other ions such as sodium and calcium. Potassium is important in physiological homeostatic control of cardiac function, but is also of relevance to the diseased state, as potassium-related effects may stabilize or destabilize cardiac function. This article aims to provide a detailed understanding of potassium-mediated cardiac function. This will help the clinical practitioner evaluate how modulation of potassium ion channels by disease and pharmacological manipulation affect the cardiac patient, thus aiding in decision making when faced with clinical problems related to potassium.

Molecular targets of curcumin for cancer therapy: an updated review.

PubMed

Kasi, Pandima Devi; Tamilselvam, Rajavel; Skalicka-Woźniak, Krystyna; Nabavi, Seyed Fazel; Daglia, Maria; Bishayee, Anupam; Pazoki-Toroudi, Hamidreza; Nabavi, Seyed Mohammad

2016-10-01

In recent years, natural edible products have been found to be important therapeutic agents for the treatment of chronic human diseases including cancer, cardiovascular disease, and neurodegeneration. Curcumin is a well-known diarylheptanoid constituent of turmeric which possesses anticancer effects under both pre-clinical and clinical conditions. Moreover, it is well known that the anticancer effects of curcumin are primarily due to the activation of apoptotic pathways in the cancer cells as well as inhibition of tumor microenvironments like inflammation, angiogenesis, and tumor metastasis. In particular, extensive studies have demonstrated that curcumin targets numerous therapeutically important cancer signaling pathways such as p53, Ras, PI3K, AKT, Wnt-β catenin, mTOR and so on. Clinical studies also suggested that either curcumin alone or as combination with other drugs possess promising anticancer effect in cancer patients without causing any adverse effects. In this article, we critically review the available scientific evidence on the molecular targets of curcumin for the treatment of different types of cancer. In addition, we also discuss its chemistry, sources, bioavailability, and future research directions.

Trustworthiness and relevance in web-based clinical question answering.

PubMed

Cruchet, Sarah; Boyer, Célia; van der Plas, Lonneke

2012-01-01

Question answering systems try to give precise answers to a user's question posed in natural language. It is of utmost importance that the answers returned are relevant to the user's question. For clinical QA, the trustworthiness of answers is another important issue. Limiting the document collection to certified websites helps to improve the trustworthiness of answers. On the other hand, limited document collections are known to harm the relevancy of answers. We show, however, in a comparative evaluation, that promoting trustworthiness has no negative effect on the relevance of the retrieved answers in our clinical QA system. On the contrary, the answers found are in general more relevant.

Cost-effectiveness of the PECARN rules in children with minor head trauma.

PubMed

Nishijima, Daniel K; Yang, Zhuo; Urbich, Michael; Holmes, James F; Zwienenberg-Lee, Marike; Melnikow, Joy; Kuppermann, Nathan

2015-01-01

To improve the efficiency and appropriateness of computed tomography (CT) use in children with minor head trauma, clinical prediction rules were derived and validated by the Pediatric Emergency Care Applied Research Network (PECARN). The objective of this study was to conduct a cost-effectiveness analysis comparing the PECARN traumatic brain injury prediction rules to usual care for selective CT use. We used decision analytic modeling to project the outcomes, costs, and cost-effectiveness of applying the PECARN rules compared with usual care in a hypothetical cohort of 1,000 children with minor blunt head trauma. Clinical management was directed by level of risk as specified by the presence or absence of variables in the PECARN traumatic brain injury prediction rules. Immediate costs of care (diagnostic testing, treatment [not including clinician time], and hospital stay) were derived on single-center data. Quality-adjusted life-year losses related to the sequelae of clinically important traumatic brain injuries and to radiation-induced cancers, number of CT scans, number of radiation-induced cancers, number of missed clinically important traumatic brain injury, and total costs were evaluated. Compared with the usual care strategy, the PECARN strategy was projected to miss slightly more children with clinically important traumatic brain injuries (0.26 versus 0.02 per 1,000 children) but used fewer cranial CT scans (274 versus 353), resulted in fewer radiation-induced cancers (0.34 versus 0.45), cost less ($904,940 versus $954,420), and had lower net quality-adjusted life-year loss (-4.64 versus -5.79). Because the PECARN strategy was more effective (less quality-adjusted life-year loss) and less costly, it dominated the usual care strategy. Results were robust under sensitivity analyses. Application of the PECARN traumatic brain injury prediction rules for children with minor head trauma would lead to beneficial outcomes and more cost-effective care. Copyright © 2014 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes

PubMed Central

Koh, Shizuka

2015-01-01

Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of “Tear Film Oriented Therapy (TFOT)”, an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described. PMID:26028958

Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes.

PubMed

Koh, Shizuka

2015-01-01

Diquafosol is a drug used for dry eye treatment with a novel mechanism of action. It stimulates the secretion of tear fluid and mucin on the ocular surface, thus enabling us to selectively treat the tear film layer, playing an important role in the establishment of the concept of "Tear Film Oriented Therapy (TFOT)", an effective therapeutic approach to dry eye in Japan. The 3% diquafosol ophthalmic solution has been widely used for the treatment of dry eye in clinical practice, and it is currently available in Japan and South Korea. This review provides an overview of the clinical utility of 3% diquafosol ophthalmic solution, focusing on the results of clinical studies on various types of dry eye, including aqueous-deficient dry eye, short tear film breakup time-type dry eye, and post dry eye after laser in situ keratomileusis. It also introduces the additive effect of diquafosol on sodium hyaluronate monotherapy for dry eye, and the effect of 3% diquafosol ophthalmic solution for dry eye-related conditions. Additionally, it summarizes the ocular effects of diquafosol in healthy human eyes. Lastly, the importance of improving tear film stability in dry eye treatment, as well as general advances in dry eye treatments, are described.

The influence of role models in undergraduate nurse education.

PubMed

Jack, Kirsten; Hamshire, Claire; Chambers, Alison

2017-12-01

To explore the concept of role modelling in undergraduate nurse education and its effect on the personal and professional development of student nurses. Effective educative strategies are important for student nurses, who have to cope with learning in both clinical and university settings. Given the contemporary issues facing nurse education and practice in the United Kingdom (UK), it is timely and important to undertake pedagogical research into the concept of role modelling as an effective educative method. A descriptive narrative approach. Unstructured interviews were conducted with 14 current/recently discontinued students from Adult and Mental Health branches of nursing degree programmes in the north-west region of England, United Kingdom (UK). Data were thematically analysed. Students valued exposure to positive role models in clinical and university settings and viewed them as beneficial to their learning. Exposure to negative role models occurred, and this provided students with opportunities to consider the type of nurse they aspired to become. In some cases, students' exposure to perceived poor practice had an adverse effect on their learning and led to negative feelings about nursing work. Clinical staff might be perceived as more relevant role models than those in the university setting although there were still opportunities for academic staff to model professional behaviours. The study found that role modelling is an effective way to support learning and led to student satisfaction across both clinical and university settings. The findings support the use of role models in nurse education, and further research about conscious positive modelling of practice is required. Exploring the use of role models is important when examining ways in which the quality of nurse education might be developed. © 2017 John Wiley & Sons Ltd.

Chimeric Antigen Receptor-Modified T Cells for Solid Tumors: Challenges and Prospects

PubMed Central

Guo, Yelei; Wang, Yao; Han, Weidong

2016-01-01

Recent studies have highlighted the successes of chimeric antigen receptor-modified T- (CART-) cell-based therapy for B-cell malignancies, and early phase clinical trials have been launched in recent years. The few published clinical studies of CART cells in solid tumors have addressed safety and feasibility, but the clinical outcome data are limited. Although antitumor effects were confirmed in vitro and in animal models, CART-cell-based therapy still faces several challenges when directed towards solid tumors, and it has been difficult to achieve the desired outcomes in clinical practice. Many studies have struggled to improve the clinical responses to and benefits of CART-cell treatment of solid tumors. In this review, the status quo of CART cells and their clinical applications for solid tumors will be summarized first. Importantly, we will suggest improvements that could increase the therapeutic effectiveness of CART cells for solid tumors and their future clinical applications. These interventions will make treatment with CART cells an effective and routine therapy for solid tumors. PMID:26998495

What makes a competent clinical teacher?

PubMed Central

Wealthall, Stephen; Henning, Marcus

2012-01-01

Background Clinical teaching competency is a professional necessity ensuring that clinicians’ knowledge, skills and attitudes are effectively transmitted from experts to novices. The aim of this paper is to consider how clinical skills are transmitted from a historical and reflective perspective and to link these ideas with student and teacher perceptions of competence in clinical teaching. Methods The reflections are informed by a Delphi process and professional development survey designed to capture students’ and clinicians’ ideas about the attributes of a competent clinical teacher. In addition, the survey process obtained information on the importance and ‘teachability’ of these characteristics. Results Four key characteristics of the competent teacher emerged from the Delphi process: clinically competent, efficient organizer, group communicator and person–centred. In a subsequent survey, students were found to be more optimistic about the ‘teachability’ of these characteristics than clinicians and scored the attribute of person-centredness higher than clinicians. Clinicians, on the other hand, ascribed higher levels of importance to clinical competency, efficient organization and group communication than students. Conclusions The Delphi process created a non-threatening system for gathering student and clinician expectations of teachers and created a foundation for developing methods for evaluating clinical competency. This provided insights into differences between teachers’ and students’ expectations, their importance, and professional development. PMID:26451184

Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

PubMed

Keefe, Richard S E; Kraemer, Helena C; Epstein, Robert S; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P; McNulty, James; Reed, Shelby D; Sanchez, Juan; Leon, Andrew C

2013-05-01

This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

Clinical Decision Support to Implement CYP2D6 Drug-Gene Interaction.

PubMed

Caraballo, Pedro J; Parkulo, Mark; Blair, David; Elliott, Michelle; Schultz, Cloann; Sutton, Joseph; Rao, Padma; Bruflat, Jamie; Bleimeyer, Robert; Crooks, John; Gabrielson, Donald; Nicholson, Wayne; Rohrer Vitek, Carolyn; Wix, Kelly; Bielinski, Suzette J; Pathak, Jyotishman; Kullo, Iftikhar

2015-01-01

The level of CYP2D6 metabolic activity can be predicted by pharmacogenomic testing, and concomitant use of clinical decision support has the potential to prevent adverse effects from those drugs metabolized by this enzyme. Our initial findings after implementation of clinical decision support alerts integrated in the electronic health records suggest high feasibility, but also identify important challenges.

The Responsiveness and Correlation between Fugl-Meyer Assessment, Motor Status Scale, and the Action Research Arm Test in Chronic Stroke with Upper-Extremity Rehabilitation Robotic Training

ERIC Educational Resources Information Center

Wei, Xi-Jun; Tong, Kai-yu; Hu, Xiao-ling

2011-01-01

Responsiveness of clinical assessments is an important element in the report of clinical effectiveness after rehabilitation. The correlation could reflect the validity of assessments as an indication of clinical performance before and after interventions. This study investigated the correlation and responsiveness of Fugl-Meyer Assessment (FMA),…

Let your communication skills equal your clinical skills.

PubMed

Demarais, Ann; Baum, Neil

2012-01-01

Relating effectively with patients is among the most valued skills of clinical care. Honing your communication skills is an art that every physician needs to learn and understand. In this era of increased volume of patients there is a tendency to lose sight of the importance of having good communication skills. This article will review 11 suggestions for letting your communication skills equal your clinical skills.

Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review.

PubMed

Saragiotto, Bruno T; Maher, Christopher G; Yamato, Tiê P; Costa, Leonardo O P; Costa, Luciola C Menezes; Ostelo, Raymond W J G; Macedo, Luciana G

2016-08-15

A systematic review. The aim of this review was to evaluate the effectiveness of motor control exercise (MCE) in patients with nonspecific low back pain (LBP). MCE is a common form of exercise used for managing LBP. MCE focuses on the activation of the deep trunk muscles and targets the restoration of control and coordination of these muscles, progressing to more complex and functional tasks integrating the activation of deep and global trunk muscles. We conducted electronic searches of CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers from their inception up to April 2015. Two independent review authors screened the search results, assessed risk of bias, and extracted the data. A third reviewer resolved any disagreement. We included randomized controlled trials comparing MCE with no treatment, another treatment, or as a supplement to other interventions in patients with nonspecific LBP. Primary outcomes were pain intensity and disability. We assessed risk of bias using the Cochrane Back and Neck (CBN) Review Group 12-item criteria. We combined results in a meta-analysis expressed as mean difference and 95% confidence interval. We assessed the overall quality of the evidence using the GRADE approach. We included 32 trials (n = 2628). Most included trials had a low risk of bias. For acute LBP, low to moderate quality evidence indicates no clinically important differences between MCE and spinal manipulative therapy or other forms of exercise. There is very low-quality evidence that the addition of MCE to medical management does not provide clinically important improvements. For recurrence at one year, there is very low-quality evidence that MCE and medical management decrease the risk of recurrence. For chronic LBP, there is low to moderate quality evidence that MCE is effective for reducing pain compared with minimal intervention. There is low to high-quality evidence that MCE is not clinically more effective than other exercises or manual therapy. There is very low to low quality evidence that MCE is clinically more effective than exercise and electrophysical agents (EPAs) or telerehabilitation for pain and disability. MCE is probably more effective than a minimal intervention for reducing pain, but probably does not have an important effect on disability, in patients with chronic LBP. There was no clinically important difference between MCE and other forms of exercises or manual therapy for acute and chronic LBP. 1.

Clinical Trials: More than an Assessment of Treatment Effect – LXV Edward Jackson Memorial Lecture

PubMed Central

Ferris, Frederick L.

2008-01-01

Purpose To review the development of clinical trials and demonstrate their value beyond the assessment of the treatment effect. Design Retrospective literature review Methods Retrospective literature review Results There has been a rapid increase in the number of clinical trials in ophthalmology as assessed by the number of ophthalmic publications and the number of ongoing National Eye Institute (NEI) sponsored clinical trials over the last four decades. The public health significance of the results of these NEI clinical trials goes beyond the demonstration of treatment effects and side effects. From these trials we learn about the clinical course and risk factors of disease allowing us to better determine who and when to treat. Furthermore, the collaboration of investigators, as they develop and carry out protocols, facilitates incorporation of new ideas into the practice of medicine. Conclusions The practice of medicine is increasingly dependent on the results of carefully designed clinical trials. The determination as to whether a new treatment is safe and effective is important, but the additional information we can obtain regarding natural history, risk factors, and patient satisfaction adds immeasurably to our ability to care for our patients. PMID:19100353

Perceived outcomes of web-based modules designed to enhance athletic trainers' knowledge of evidence-based practice.

PubMed

Welch, Cailee E; Van Lunen, Bonnie L; Hankemeier, Dorice A; Wyant, Aimee L; Mutchler, Jessica M; Pitney, William A; Hays, Danica G

2014-01-01

The release of evidence-based practice (EBP) Web-based learning modules to the membership of the National Athletic Trainers' Association has provided athletic trainers (ATs) the opportunity to enhance their knowledge of the various EBP concepts. Whereas increasing the knowledge of EBP among ATs is important, assessing whether this newfound knowledge is being translated into clinical practice and didactic education is crucial. To explore the effectiveness of an educational intervention regarding EBP on the didactic instruction patterns of athletic training educators and the clinical practice behaviors of clinicians. Qualitative study. Individual telephone interviews. A total of 25 ATs (12 educators, 13 clinicians; experience as an AT = 16.00 ± 9.41 years) were interviewed. We conducted 1 individual telephone interview with each participant. After transcription, the data were analyzed and coded into common themes and categories. Triangulation of the data occurred via the use of multiple researchers and member checking to confirm the accuracy of the data. Participants perceived the EBP Web-based modules to produce numerous outcomes regarding education and clinical practice. These outcomes included perceived knowledge gain among participants, an increase in the importance and scope of EBP, a positive effect on educators' didactic instruction patterns and on instilling value and practice of EBP among students, and an enhanced ability among clinicians to implement EBP within clinical practice. However, some clinicians reported the Web-based modules had no current effect on clinical practice. Although the EBP Web-based modules were successful at enhancing knowledge among ATs, translation of knowledge into the classroom and clinical practice remains limited. Researchers should aim to identify effective strategies to help ATs implement EBP concepts into didactic education and clinical practice.

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.

Perceived Outcomes of Web-Based Modules Designed to Enhance Athletic Trainers' Knowledge of Evidence-Based Practice

PubMed Central

Welch, Cailee E.; Van Lunen, Bonnie L.; Hankemeier, Dorice A.; Wyant, Aimee L.; Mutchler, Jessica M.; Pitney, William A.; Hays, Danica G.

2014-01-01

Context: The release of evidence-based practice (EBP) Web-based learning modules to the membership of the National Athletic Trainers' Association has provided athletic trainers (ATs) the opportunity to enhance their knowledge of the various EBP concepts. Whereas increasing the knowledge of EBP among ATs is important, assessing whether this newfound knowledge is being translated into clinical practice and didactic education is crucial. Objective: To explore the effectiveness of an educational intervention regarding EBP on the didactic instruction patterns of athletic training educators and the clinical practice behaviors of clinicians. Design: Qualitative study. Setting: Individual telephone interviews. Patients or Other Participants: A total of 25 ATs (12 educators, 13 clinicians; experience as an AT = 16.00 ± 9.41 years) were interviewed. Data Collection and Analysis: We conducted 1 individual telephone interview with each participant. After transcription, the data were analyzed and coded into common themes and categories. Triangulation of the data occurred via the use of multiple researchers and member checking to confirm the accuracy of the data. Results: Participants perceived the EBP Web-based modules to produce numerous outcomes regarding education and clinical practice. These outcomes included perceived knowledge gain among participants, an increase in the importance and scope of EBP, a positive effect on educators' didactic instruction patterns and on instilling value and practice of EBP among students, and an enhanced ability among clinicians to implement EBP within clinical practice. However, some clinicians reported the Web-based modules had no current effect on clinical practice. Conclusions: Although the EBP Web-based modules were successful at enhancing knowledge among ATs, translation of knowledge into the classroom and clinical practice remains limited. Researchers should aim to identify effective strategies to help ATs implement EBP concepts into didactic education and clinical practice. PMID:24576306

Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer’s Disease

PubMed Central

Arendash, Gary W.

2016-01-01

We have demonstrated in multiple studies that daily, long-term electromagnetic field (EMF) treatment in the ultra-high frequency range not only protects Alzheimer’s disease (AD) transgenic mice from cognitive impairment, but also reverses such impairment in aged AD mice. Moreover, these beneficial cognitive effects appear to be through direct actions on the AD process. Based on a large array of pre-clinical data, we have initiated a pilot clinical trial to determine the safety and efficacy of EMF treatment to mild-moderate AD subjects. Since it is important to establish the safety of this new neuromodulatory approach, the main purpose of this review is to provide a comprehensive assessment of evidence supporting the safety of EMFs, particularly through transcranial electromagnetic treatment (TEMT). In addition to our own pre-clinical studies, a rich variety of both animal and cell culture studies performed by others have underscored the anticipated safety of TEMT in clinical AD trials. Moreover, numerous clinical studies have determined that short- or long-term human exposure to EMFs similar to those to be provided clinically by TEMT do not have deleterious effects on general health, cognitive function, or a variety of physiologic measures—to the contrary, beneficial effects on brain function/activity have been reported. Importantly, such EMF exposure has not been shown to increase the risk of any type of cancer in human epidemiologic studies, as well as animal and cell culture studies. In view of all the above, clinical trials of safety/efficacy with TEMT to AD subjects are clearly warranted and now in progress. PMID:27258417

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

"Radiobiology of Proton Therapy": Results of an international expert workshop.

PubMed

Lühr, Armin; von Neubeck, Cläre; Pawelke, Jörg; Seidlitz, Annekatrin; Peitzsch, Claudia; Bentzen, Søren M; Bortfeld, Thomas; Debus, Jürgen; Deutsch, Eric; Langendijk, Johannes A; Loeffler, Jay S; Mohan, Radhe; Scholz, Michael; Sørensen, Brita S; Weber, Damien C; Baumann, Michael; Krause, Mechthild

2018-05-31

The physical properties of proton beams offer the potential to reduce toxicity in tumor-adjacent normal tissues. Toward this end, the number of proton radiotherapy facilities has steeply increased over the last 10-15 years to currently around 70 operational centers worldwide. However, taking full advantage of the opportunities offered by proton radiation for clinical radiotherapy requires a better understanding of the radiobiological effects of protons alone or combined with drugs or immunotherapy on normal tissues and tumors. This report summarizes the main results of the international expert workshop "Radiobiology of Proton Therapy" that was held in November 2016 in Dresden. It addresses the major topics (1) relative biological effectiveness (RBE) in proton beam therapy, (2) interaction of proton radiobiology with radiation physics in current treatment planning, (3) biological effects in proton therapy combined with systemic treatments, and (4) testing biological effects of protons in clinical trials. Finally, important research avenues for improvement of proton radiotherapy based on radiobiological knowledge are identified. The clinical distribution of radiobiological effectiveness of protons alone or in combination with systemic chemo- or immunotherapies as well as patient stratification based on biomarker expressions are key to reach the full potential of proton beam therapy. Dedicated preclinical experiments, innovative clinical trial designs, and large high-quality data repositories will be most important to achieve this goal. Copyright © 2018 Elsevier B.V. All rights reserved.

Clinical informatics in undergraduate teaching of health informatics.

PubMed

Pantazi, Stefan V; Pantazi, Felicia; Daly, Karen

2011-01-01

We are reporting on a recent experience with Health Informatics (HI) teaching at undergraduate degree level to an audience of HI and Pharmacy students. The important insight is that effective teaching of clinical informatics must involve highly interactive, applied components in addition to the traditional theoretical material. This is in agreement with general literature underlining the importance of simulations and role playing in teaching and is well supported by our student evaluation results. However, the viability and sustainability of such approaches to teaching hinges on significant course preparation efforts. These efforts consist of time-consuming investigations of informatics technologies, applications and systems followed by the implementation of workable solutions to a wide range of technical problems. In effect, this approach to course development is an involved process that relies on a special form of applied research whose technical complexity could explain the dearth of published reports on similar approaches in HI education. Despite its difficulties, we argue that this approach can be used to set a baseline for clinical informatics training at undergraduate level and that its implications for HI education in Canada are of importance.

Prelicensure Baccalaureate Nursing Students' Perceptions of Their Development of Clinical Reasoning.

PubMed

Herron, Elizabeth K; Sudia, Tanya; Kimble, Laura P; Davis, Alison H

2016-06-01

Establishing a strong foundation for the development of clinical reasoning in nursing students is essential to ensure safe and effective patient care. This study explored prelicensure baccalaureate nursing students' perceptions of their development of clinical reasoning, as well as their perceptions of how it is taught. In this phenomenological study, individual semistructured interviews were conducted to gather data related to participants' perceptions of their development of clinical reasoning. Data were analyzed using procedural steps delineated by Giorgi. Data analysis revealed three main themes: Instructor Characteristics, Importance of Clinical Reasoning, and Best Place to Learn Clinical Reasoning. Students recognized how clinical reasoning enhances safe and effective clinical practice and indicated the clinical arena was the most beneficial environment in which to learn clinical reasoning. Understanding students' perceptions of learning benefits nurse educators in planning nursing program curricula to enhance and facilitate the development of clinical reasoning. [J Nurs Educ. 2016;55(6):329-335.]. Copyright 2016, SLACK Incorporated.

Clinical biomarkers of angiogenesis inhibition

PubMed Central

Brown, Aaron P.; Citrin, Deborah E.; Camphausen, Kevin A.

2009-01-01

Introduction An expanding understanding of the importance of angiogenesis in oncology and the development of numerous angiogenesis inhibitors are driving the search for biomarkers of angiogenesis. We review currently available candidate biomarkers and surrogate markers of anti-angiogenic agent effect. Discussion A number of invasive, minimally invasive, and non-invasive tools are described with their potential benefits and limitations. Diverse markers can evaluate tumor tissue or biological fluids, or specialized imaging modalities. Conclusions The inclusion of these markers into clinical trials may provide insight into appropriate dosing for desired biological effects, appropriate timing of additional therapy, prediction of individual response to an agent, insight into the interaction of chemotherapy and radiation following exposure to these agents, and perhaps most importantly, a better understanding of the complex nature of angiogenesis in human tumors. While many markers have potential for clinical use, it is not yet clear which marker or combination of markers will prove most useful. PMID:18414993

Disseminating a clinically effective physical activity program to preserve mobility in a community setting for older adults

USDA-ARS?s Scientific Manuscript database

Background: As the population of older adults continues to increase, the dissemination of strategies to maintain independence of older persons is of critical public health importance. Recent large-scale clinical trial evidence has definitively shown intervention of moderate-intensity physical activi...

The Autonomous Self vs. the Relational Self: Implications for Clinical Assessment and Treatment in Child Psychotherapy.

ERIC Educational Resources Information Center

Atwood, Richard; Safyer, Andrew W.

1993-01-01

Reviews and discusses the debate between the traditional psychoanalytic perspective on separation-individuation and the newer "rational" view of self-development. Finds each have equal importance both for understanding psychopathology and for providing effective and empathically-attuned psychotherapy. Provides clinical vignettes derived…

Reflective Observation in the Clinical Education Setting: A Way to Promote Learning

ERIC Educational Resources Information Center

Mazerolle, Stephanie M.; Bowman, Thomas G.; Benes, Sarah S.

2015-01-01

Context: Clinical experiences help athletic training students gain real-time learning experiences by engaging in patient care. Observational learning has been identified as important to athletic training student development, yet little is known about its effectiveness. Objective: To explore the athletic training students' perspectives on their…

Clinical and Practicum Education in the Professions: The Student Voice

ERIC Educational Resources Information Center

Ralph, Edwin; Wimmer, Randy; Walker, Keith

2008-01-01

Undergraduate students in professional education programs typically rate their clinical or practicum experiences as the most important component of their entire pre-service preparation. This essay addresses the value of students' views regarding the effectiveness of practicum programs. We summarize the views of 546 post-practicum students from…

Monthly high dose vitamin D treatment for the prevention of functional decline: a randomized clinical trial

USDA-ARS?s Scientific Manuscript database

Importance: Vitamin D deficiency has been associated with poor physical performance. Objective: To determine the effectiveness of high dose vitamin D in lowering the risk of functional decline. Design, Setting, and Participants: One-year double-blind, randomized clinical trial conducted in Zurich,...

Exercise Ventilatory Limitation: The Role Of Expiratory Flow Limitation

PubMed Central

Babb, Tony G.

2012-01-01

Ventilatory limitation to exercise remains an important unresolved clinical issue; as a result, many individuals misinterpret the effects of expiratory flow limitation as an all-or-nothing phenomenon. Expiratory flow limitation is not all-or-none; approaching maximal expiratory flow can have important effects not only on ventilatory capacity but also on breathing mechanics, ventilatory control, and possibly exertional dyspnea and exercise intolerance. PMID:23038244

Clinical Decision Support: Effectiveness in Improving Quality Processes and Clinical Outcomes and Factors That May Influence Success

PubMed Central

Murphy, Elizabeth V.

2014-01-01

The use of electronic health records has skyrocketed following the 2009 HITECH Act, which provides financial incentives to health care providers for the “meaningful use” of electronic medical record systems. An important component of the “Meaningful Use” legislation is the integration of Clinical Decision Support Systems (CDSS) into the computerized record, providing up-to-date medical knowledge and evidence-based guidance to the physician at the point of care. As reimbursement is increasingly tied to process and clinical outcomes, CDSS will be integral to future medical practice. Studies of CDSS indicate improvement in preventive services, appropriate care, and clinical and cost outcomes with strong evidence for CDSS effectiveness in process measures. Increasing provider adherence to CDSS recommendations is essential in improving CDSS effectiveness, and factors that influence adherence are currently under study. PMID:24910564

Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

NASA Astrophysics Data System (ADS)

Chaibub Neto, Elias

2016-11-01

Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

[The informed consent in international clinical trials including developing countries].

PubMed

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

Resistant starch: a promising dietary agent for the prevention/treatment of inflammatory bowel disease and bowel cancer.

PubMed

Higgins, Janine A; Brown, Ian L

2013-03-01

Resistant starch represents a diverse range of indigestible starch-based dietary carbohydrates. Resistant starch has been investigated in the past for its effects on bowel health (pH, epithelial thickness, and apoptosis of colorectal cancer cells); reduction in postprandial glycemia; increased insulin sensitivity; and effects on the gut microbiome. This review highlights advances as resistant starch gains clinical relevance as a potential treatment/preventive tool for diseases such as colorectal cancer (CRC) and diabetes. Recent articles have evaluated the comparative physiological effects of different types of resistant starch and investigated the effects of resistant starch on blood lipids, body weight, and defining resistant starch-induced changes to the micriobiome that may be important in health and disease. The most novel and relevant recent data describe a role for resistant starch in ameliorating inflammation; the use of resistant starch for optimal bowel health and prevention of CRC; and, further, that the systemic effects of resistant starch may be important for the treatment of other forms of cancer, such as breast cancer. This review describes advances in resistant starch research highlighting the gastrointestinal effects that are now being linked to systemic, whole body effects with clinical relevance. These effects have important implications for overall health and the prevention or amelioration of various chronic diseases.

What are the pros and cons of electronically monitoring inhaler use in asthma? A multistakeholder perspective.

PubMed

Howard, Sam; Lang, Alexandra; Sharples, Sarah; Shaw, Dominick

2016-01-01

Electronic monitoring devices (EMDs) are the optimal method for collecting objective data on inhaler use in asthma. Recent research has investigated the attitudes of patients with asthma towards these devices. However, no research to date has formally considered the opinions of stakeholders and decision-makers in asthma care. These individuals have important clinical requirements that need to be taken into account if EMDs are to be successfully provisioned, making collecting their opinions on the key barriers facing these devices a valuable process. Three rounds of surveys in a Delphi format were used to assess the most important pros and cons of EMDs for asthma care in a sample of 31 stakeholders which included healthcare professionals and members of clinical commissioning groups. The respondents identified 29 pros and 32 cons. Pros that were rated as most important included new visual evidence to aid clinical discussions with a patient and an increase in patient involvement and motivation. The cons that were rated as most important included a need for more clinical evidence of the effectiveness of EMDs, as well as better clarity over who has responsibilities in managing, interpreting and discussing data with a patient. The research provides a guide for EMD developers by highlighting where these devices may provide the most benefit as well as prioritising the key issues that need addressing if they are to be used effectively in everyday asthma care.

What are the pros and cons of electronically monitoring inhaler use in asthma? A multistakeholder perspective

PubMed Central

Howard, Sam; Lang, Alexandra; Sharples, Sarah; Shaw, Dominick

2016-01-01

Introduction Electronic monitoring devices (EMDs) are the optimal method for collecting objective data on inhaler use in asthma. Recent research has investigated the attitudes of patients with asthma towards these devices. However, no research to date has formally considered the opinions of stakeholders and decision-makers in asthma care. These individuals have important clinical requirements that need to be taken into account if EMDs are to be successfully provisioned, making collecting their opinions on the key barriers facing these devices a valuable process. Methods Three rounds of surveys in a Delphi format were used to assess the most important pros and cons of EMDs for asthma care in a sample of 31 stakeholders which included healthcare professionals and members of clinical commissioning groups. Results The respondents identified 29 pros and 32 cons. Pros that were rated as most important included new visual evidence to aid clinical discussions with a patient and an increase in patient involvement and motivation. The cons that were rated as most important included a need for more clinical evidence of the effectiveness of EMDs, as well as better clarity over who has responsibilities in managing, interpreting and discussing data with a patient. Conclusions The research provides a guide for EMD developers by highlighting where these devices may provide the most benefit as well as prioritising the key issues that need addressing if they are to be used effectively in everyday asthma care. PMID:27933181

Clinical learning environment at Shiraz Medical School.

PubMed

Rezaee, Rita; Ebrahimi, Sedigheh

2013-01-01

Clinical learning occurs in the context of a dynamic environment. Learning environment found to be one of the most important factors in determining the success of an effective teaching program. To investigate, from the attending and resident's perspective, factors that may affect student leaning in the educational hospital setting at Shiraz University of Medical Sciences (SUMS). This study combined qualitative and quantitative methods to determine factors affecting effective learning in clinical setting. Residents evaluated the perceived effectiveness of the university hospital learning environment. Fifty two faculty members and 132 residents participated in this study. Key determinants that contribute to an effective clinical teaching were autonomy, supervision, social support, workload, role clarity, learning opportunity, work diversity and physical facilities. In a good clinical setting, residents should be appreciated and given appropriate opportunities to study in order to meet their objectives. They require a supportive environment to consolidate their knowledge, skills and judgment. © 2013 Tehran University of Medical Sciences. All rights reserved.

A concomitant review of the effects of diabetes mellitus and hypothyroidism in wound healing

PubMed Central

Ekmektzoglou, Konstantinos A; Zografos, Georgios C

2006-01-01

This paper reviews the negative impact of diabetes mellitus or hypothyroidism on wound healing, both in experimental and clinical settings. Since both are metabolic disorders of great clinical importance, special attention is given, not only to their pathophysiology, but also to their biochemical and histological effects on tissue integrity and regeneration. Also, special focus is awarded on wound healing of the gastrointestinal tract, i.e. in intestinal anastomosis, and how these disorders can lead to wound dehiscence. Since diabetes mellitus and hypothyroidism can coexist in clinical settings, more research must be directed on their influence on wound healing, considering them as one clinical entity. PMID:16718759

Clinically Enhancing Local Anesthesia Techniques for Endodontic Treatment.

PubMed

Bahcall, James; Xie, Qian

2017-02-01

Local anesthesia is one of the most important drugs given to patients who undergo endodontic treatment. Yet, clinicians often do not view local anesthetic agents as drugs and, therefore, struggle clinically to consistently achieve profound pulpal anesthesia. To improve the clinical effects of local anesthesia for endodontic treatment, in conjunction with selecting the correct type of local anesthesia, clinicians need to thoroughly understand how the local anesthetic process works and how to objectively test for clinical signs of pulpal anesthesia and integrate supplemental anesthesia when appropriate.

Clinical results in cachexia therapeutics.

PubMed

Crawford, Jeffrey

2016-05-01

This article highlights recent developments in the area of cancer cachexia and therapeutic interventions. Therapeutic interventions in cancer cachexia have been guided by clinical studies focused on the central role of muscle and the increased use of CT imaging to measure the impact of skeletal muscle loss on clinical outcomes. At the translational level, a number of different model systems have emphasized the importance of blockade of tumor-induced inflammation and its potential impact on reversing the cachexia phenotype, including FN14, a receptor in the TNF pathway, as well as the parathyroid hormone-related protein. Clinical studies continue to demonstrate the importance of nutrition and exercise as part of a multimodality approach. Although a number of promising agents are being evaluated, both enobosarm, a selected androgen receptor modulator, and anamorelin, a ghrelin agonist have completed phase III trials. Both agents have shown significant impact on reversal of skeletal muscle loss, but inconsistent effect on physical function improvement. Anamorelin also has a positive effect on appetite and weight gain. Further analysis of these studies, along with regulatory guidance, will be critical in the further development of these and other promising agents in the clinical management of patients with cancer cachexia.

What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study).

PubMed

Kwon, S; Perera, S; Pahor, M; Katula, J A; King, A C; Groessl, E J; Studenski, S A

2009-06-01

Performance measures provide important information, but the meaning of change in these measures is not well known. The purpose of this research is to 1) examine the effect of treatment assignment on the relationship between self-report and performance; 2) to estimate the magnitude of meaningful change in 400-meter walk time (400MWT), 4-meter gait speed (4MGS), and Short Physical Performance Battery (SPPB) and 3) to evaluate the effect of direction of change on estimates of magnitude. This is a secondary analysis of data from the LIFE-P study, a single blinded randomized clinical trial. Using change over one year, we applied distribution-based and anchor-based methods for self-reported mobility to estimate minimally important and substantial change in 400MWT, 4MGS and SPPB. Four university-based clinical research sites. Sedentary adults aged 70-89 whose SPPB scores were less than 10 and who were able to complete a 400MW at baseline (n=424). A structured exercise program versus health education. 400MWT, 4MGS, SPPB. Relationships between self-report and performance measures were consistent between treatment arms. Minimally significant change estimates were 400MWT: 20-30 seconds, 4MGS: 0.03-0.05m/s and SPPB: 0.3 - 0.8 points. Substantial changes were 400MWT: 50-60 seconds, 4MGS: 0.08m/s, SPPB: 0.4 - 1.5 points. Magnitudes of change for improvement and decline were not significantly different. The magnitude of clinically important change in physical performance measures is reasonably consistent using several analytic techniques and appears to be achievable in clinical trials of exercise. Due to limited power, the effect of direction of change on estimates of magnitude remains uncertain.

Evolution of Functional Family Therapy as an Evidence-Based Practice for Adolescents with Disruptive Behavior Problems.

PubMed

Robbins, Michael S; Alexander, James F; Turner, Charles W; Hollimon, Amy

2016-09-01

This article summarizes the evolution of functional family therapy (FFT) based upon four decades of clinical practice and scientific scrutiny through research evidence. FFT research has evolved from an initial focus upon clinical process research, which examined sequential exchanges between therapists and family members. A key element of this research has been an examination of the way in which clinicians acquire, consolidate, and maintain the skills needed to implement FFT effectively with youth and families. Many randomized efficacy and effectiveness studies have evaluated the impact of FFT across diverse clinical populations. Subsequent research investigated factors that influence the effectiveness of implementation across more than 300 clinical settings in which more than 2,500 trained clinicians have provided service to nearly 400,000 families. Another important set of investigations concerned the cost-effectiveness of the interventions. © 2016 Family Process Institute.

[Effective communication strategies to frame the trainer-trainee dialogue in the clinical setting].

PubMed

Gachoud, D; Félix, S; Monti, M

2015-11-04

Communication between trainer and trainee plays a central role in teaching and learning in the clinical environment. There are various strategies to frame the dialogue between trainee and trainer. These strategies allow trainers to be more effective in their supervision, which is important in our busy clinical environment. Communication strategies are well adapted to both in- and out-patient settings, to both under- and postgraduate contexts. This article presents three strategies that we think are particularly useful. They are meant to give feedback, to ask questions and to present a case.

The role of effective communication in achieving informed consent for clinical trials.

PubMed

Pick, Andrew; Gilbert, Kayleigh; McCaul, James

2014-11-11

Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.

A method for assessing the cost-effectiveness and the break-even point of clinical practice guidelines.

PubMed

Gandjour, A; Lauterbach, K W

2001-01-01

Assessing the costs and benefits of developing a clinical practice guideline is important because investments in guidelines compete with investments in other clinical programs. Despite the considerable number of guidelines in many industrialized countries, little is known about their costs and cost-effectiveness. The authors have developed specific measures to determine the cost-effectiveness of guidelines, using a German evidence-based guideline on obesity for the diagnosis and treatment of obese patients as a model. The measures are: the number of people needed to cure, the number of people needed to prevent from developing the disease in question, and the number of people to treat in order to break even.

Immunosuppression by hypoxic cell radiosensitizers: a phenomenon of potential clinical importance

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

Rockwell, S.; Kapp, D.S.

1982-06-01

The nitroimidazoles metronidazole, misonidazol, and desmethyl misonidazole are currently undergoing clinical trials as possible adjuncts to radiotherapy. Ongoing clinical trials are evaluating the effectiveness of these agents and also documenting the pharmacokinetics and toxicities of radiosensitizing doses of these drugs in man. A variety of toxic effects have been noted in man, including anorexia, nausea and vomiting, peripheral neuropathy, central nervous system symptoms, ototoxicity, allergy, and fear. Laboratory studies have also suggested that these agents have potential to be mutagenic, carcinogenic, and teratogenic. In the editorial presented, the author attempts to draw attention to an additional toxic effect of nitroimidazolesmore » - the inhibition of cell-mediated immune responses. (JMT)« less

Influence on general practitioners of teaching undergraduates: qualitative study of London general practitioner teachers

PubMed Central

Hartley, Sarah; Macfarlane, Fraser; Gantley, Madeleine; Murray, Elizabeth

1999-01-01

Objective To examine the perceived effect of teaching clinical skills and associated teacher training programmes on general practitioners' morale and clinical practice. Design Qualitative semistructured interview study. Setting General practices throughout north London. Subjects 30 general practitioners who taught clinical skills were asked about the effect of teaching and teacher training on their morale, confidence in clinical and teaching skills, and clinical practice. Results The main theme was a positive effect on morale. Within teacher training this was attributed to developing peer and professional support; improved teaching skills; and revision of clinical knowledge and skills. Within teaching this was attributed to a broadening of horizons; contact with enthusiastic students; increased time with patients; improved clinical practice; improved teaching skills; and an improved image of the practice. Problems with teaching were due to external factors such as lack of time and space and anxieties about adequacy of clinical cover while teaching. Conclusions Teaching clinical skills can have a positive effect on the morale of general practitioner teachers as a result of contact with students and peers, as long as logistic and funding issues are adequately dealt with. Key messagesThe increase in community based teaching of clinical skills requires an increase in the number of general practitioner teachersLittle evidence is available about the effect of teaching of clinical skills and teacher training on general practitioner teachers and practicesGeneral practitioner teachers reported an increase in morale, improvements in clinical skills, and changes in clinical practice and in practice infrastructure as a result of teaching and trainingGeneral practitioner teachers reported problems because of pressure on time, lack of space, problems recruiting patients, and unsupportive practice partnersPositive effects on morale and clinical practice may be important for sustainable teaching and continuing medical education PMID:10541508

Clinical knowledge-based inverse treatment planning

NASA Astrophysics Data System (ADS)

Yang, Yong; Xing, Lei

2004-11-01

Clinical IMRT treatment plans are currently made using dose-based optimization algorithms, which do not consider the nonlinear dose-volume effects for tumours and normal structures. The choice of structure specific importance factors represents an additional degree of freedom of the system and makes rigorous optimization intractable. The purpose of this work is to circumvent the two problems by developing a biologically more sensible yet clinically practical inverse planning framework. To implement this, the dose-volume status of a structure was characterized by using the effective volume in the voxel domain. A new objective function was constructed with the incorporation of the volumetric information of the system so that the figure of merit of a given IMRT plan depends not only on the dose deviation from the desired distribution but also the dose-volume status of the involved organs. The conventional importance factor of an organ was written into a product of two components: (i) a generic importance that parametrizes the relative importance of the organs in the ideal situation when the goals for all the organs are met; (ii) a dose-dependent factor that quantifies our level of clinical/dosimetric satisfaction for a given plan. The generic importance can be determined a priori, and in most circumstances, does not need adjustment, whereas the second one, which is responsible for the intractable behaviour of the trade-off seen in conventional inverse planning, was determined automatically. An inverse planning module based on the proposed formalism was implemented and applied to a prostate case and a head-neck case. A comparison with the conventional inverse planning technique indicated that, for the same target dose coverage, the critical structure sparing was substantially improved for both cases. The incorporation of clinical knowledge allows us to obtain better IMRT plans and makes it possible to auto-select the importance factors, greatly facilitating the inverse planning process. The new formalism proposed also reveals the relationship between different inverse planning schemes and gives important insight into the problem of therapeutic plan optimization. In particular, we show that the EUD-based optimization is a special case of the general inverse planning formalism described in this paper.

The effectiveness of an air cleaner in controlling droplet/aerosol particle dispersion emitted from a patient's mouth in the indoor environment of dental clinics.

PubMed

Chen, Chun; Zhao, Bin; Cui, Weilin; Dong, Lei; An, Na; Ouyang, Xiangying

2010-07-06

Dental healthcare workers (DHCWs) are at high risk of occupational exposure to droplets and aerosol particles emitted from patients' mouths during treatment. We evaluated the effectiveness of an air cleaner in reducing droplet and aerosol contamination by positioning the device in four different locations in an actual dental clinic. We applied computational fluid dynamics (CFD) methods to solve the governing equations of airflow, energy and dispersion of different-sized airborne droplets/aerosol particles. In a dental clinic, we measured the supply air velocity and temperature of the ventilation system, the airflow rate and the particle removal efficiency of the air cleaner to determine the boundary conditions for the CFD simulations. Our results indicate that use of an air cleaner in a dental clinic may be an effective method for reducing DHCWs' exposure to airborne droplets and aerosol particles. Further, we found that the probability of droplet/aerosol particle removal and the direction of airflow from the cleaner are both important control measures for droplet and aerosol contamination in a dental clinic. Thus, the distance between the air cleaner and droplet/aerosol particle source as well as the relative location of the air cleaner to both the source and the DHCW are important considerations for reducing DHCWs' exposure to droplets/aerosol particles emitted from the patient's mouth during treatments.

The effectiveness of an air cleaner in controlling droplet/aerosol particle dispersion emitted from a patient's mouth in the indoor environment of dental clinics

PubMed Central

Chen, Chun; Zhao, Bin; Cui, Weilin; Dong, Lei; An, Na; Ouyang, Xiangying

2010-01-01

Dental healthcare workers (DHCWs) are at high risk of occupational exposure to droplets and aerosol particles emitted from patients' mouths during treatment. We evaluated the effectiveness of an air cleaner in reducing droplet and aerosol contamination by positioning the device in four different locations in an actual dental clinic. We applied computational fluid dynamics (CFD) methods to solve the governing equations of airflow, energy and dispersion of different-sized airborne droplets/aerosol particles. In a dental clinic, we measured the supply air velocity and temperature of the ventilation system, the airflow rate and the particle removal efficiency of the air cleaner to determine the boundary conditions for the CFD simulations. Our results indicate that use of an air cleaner in a dental clinic may be an effective method for reducing DHCWs' exposure to airborne droplets and aerosol particles. Further, we found that the probability of droplet/aerosol particle removal and the direction of airflow from the cleaner are both important control measures for droplet and aerosol contamination in a dental clinic. Thus, the distance between the air cleaner and droplet/aerosol particle source as well as the relative location of the air cleaner to both the source and the DHCW are important considerations for reducing DHCWs' exposure to droplets/aerosol particles emitted from the patient's mouth during treatments. PMID:20031985

Patient-specific bone modeling and analysis: the role of integration and automation in clinical adoption.

PubMed

Zadpoor, Amir A; Weinans, Harrie

2015-03-18

Patient-specific analysis of bones is considered an important tool for diagnosis and treatment of skeletal diseases and for clinical research aimed at understanding the etiology of skeletal diseases and the effects of different types of treatment on their progress. In this article, we discuss how integration of several important components enables accurate and cost-effective patient-specific bone analysis, focusing primarily on patient-specific finite element (FE) modeling of bones. First, the different components are briefly reviewed. Then, two important aspects of patient-specific FE modeling, namely integration of modeling components and automation of modeling approaches, are discussed. We conclude with a section on validation of patient-specific modeling results, possible applications of patient-specific modeling procedures, current limitations of the modeling approaches, and possible areas for future research. Copyright © 2014 Elsevier Ltd. All rights reserved.

Efficacy, Tolerability, and Dose-Dependent Effects of Opioid Analgesics for Low Back Pain: A Systematic Review and Meta-analysis.

PubMed

Abdel Shaheed, Christina; Maher, Chris G; Williams, Kylie A; Day, Richard; McLachlan, Andrew J

2016-07-01

Opioid analgesics are commonly used for low back pain, however, to our knowledge there has been no systematic evaluation of the effect of opioid dose and use of enrichment study design on estimates of treatment effect. To evaluate efficacy and tolerability of opioids in the management of back pain; and investigate the effect of opioid dose and use of an enrichment study design on treatment effect. Medline, EMBASE, CENTRAL, CINAHL, and PsycINFO (inception to September 2015) with citation tracking from eligible randomized clinical trials (RCTs). Placebo-controlled RCTs in any language. Two authors independently extracted data and assessed risk of bias. Data were pooled using a random effects model with strength of evidence assessed using the grading of recommendations assessment, development, and evaluation (GRADE). The primary outcome measure was pain. Pain and disability outcomes were converted to a common 0 to 100 scale, with effects greater than 20 points considered clinically important. Of 20 included RCTs of opioid analgesics (with a total of 7925 participants), 13 trials (3419 participants) evaluated short-term effects on chronic low back pain, and no placebo-controlled trials enrolled patients with acute low back pain. In half of these 13 trials, at least 50% of participants withdrew owing to adverse events or lack of efficacy. There was moderate-quality evidence that opioid analgesics reduce pain in the short term; mean difference (MD), -10.1 (95% CI, -12.8 to -7.4). Meta-regression revealed a 12.0 point greater pain relief for every 1 log unit increase in morphine equivalent dose (P = .046). Clinically important pain relief was not observed within the dose range evaluated (40.0-240.0-mg morphine equivalents per day). There was no significant effect of enrichment study design. For people with chronic low back pain who tolerate the medicine, opioid analgesics provide modest short-term pain relief but the effect is not likely to be clinically important within guideline recommended doses. Evidence on long-term efficacy is lacking. The efficacy of opioid analgesics in acute low back pain is unknown.

Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

PubMed Central

Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

2013-01-01

Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

Solute transport across the articular surface of injured cartilage.

PubMed

Chin, Hooi Chuan; Moeini, Mohammad; Quinn, Thomas M

2013-07-15

Solute transport through extracellular matrix (ECM) is important to physiology and contrast agent-based clinical imaging of articular cartilage. Mechanical injury is likely to have important effects on solute transport since it involves alteration of ECM structure. Therefore it is of interest to characterize effects of mechanical injury on solute transport in cartilage. Using cartilage explants injured by an established mechanical compression protocol, effective partition coefficients and diffusivities of solutes for transport across the articular surface were measured. A range of fluorescent solutes (fluorescein isothiocyanate, 4 and 40kDa dextrans, insulin, and chondroitin sulfate) and an X-ray contrast agent (sodium iodide) were used. Mechanical injury was associated with a significant increase in effective diffusivity versus uninjured explants for all solutes studied. On the other hand, mechanical injury had no effects on effective partition coefficients for most solutes tested, except for 40kDa dextran and chondroitin sulfate where small but significant changes in effective partition coefficient were observed in injured explants. Findings highlight enhanced diffusive transport across the articular surface of injured cartilage, which may have important implications for injury and repair situations. Results also support development of non-equilibrium methods for identification of focal cartilage lesions by contrast agent-based clinical imaging. Copyright © 2013 Elsevier Inc. All rights reserved.

A Strategy to Use Soft Data Effectively in Randomized Controlled Clinical Trials.

ERIC Educational Resources Information Center

Kraemer, Helena Chmura; Thiemann, Sue

1989-01-01

Sees soft data, measures having substantial intrasubject variability due to errors of measurement or response inconsistency, as important measures of response in randomized clinical trials. Shows that using intensive design and slope of response on time as outcome measure maximizes sample retention and decreases within-group variability, thus…

The Impact of Humanities-Based Teaching and Learning Strategies on Critical Thinking and Clinical Reasoning Development among BSN Students

ERIC Educational Resources Information Center

Brodhead, Josette

2016-01-01

The ability to function effectively in a dynamic, culturally diverse healthcare environment requires both critical thinking and clinical reasoning skills. The American Association of Colleges of Nursing (AACN, 2008) recognizes the importance of humanities in the baccalaureate nursing curriculum. This quasi-experimental, nonrandomized…

Parental Functioning in Families of Children with ADHD: Evidence for Behavioral Parent Training and Importance of Clinically Meaningful Change

ERIC Educational Resources Information Center

Gerdes, Alyson C.; Haack, Lauren M.; Schneider, Brian W.

2012-01-01

Objective/Method: Statistically significant and clinically meaningful effects of behavioral parent training on parental functioning were examined for 20 children with ADHD and their parents who had successfully completed a psychosocial treatment for ADHD. Results/Conclusion: Findings suggest that behavioral parent training resulted in…

Medical Management of Parkinson’s Disease: Focus on Neuroprotection

PubMed Central

Boll, Marie-Catherine; Alcaraz-Zubeldia, Mireya; Rios, Camilo

2011-01-01

Neuroprotection refers to the protection of neurons from excitotoxicity, oxidative stress and apoptosis as principal mechanisms of cell loss in a variety of diseases of the central nervous system. Our interest in Parkinson’s disease (PD) treatment is focused on drugs with neuroprotective properties in preclinical experiments and evidence-based efficacy in human subjects. To this date, neuroprotection has never been solidly proven in clinical trials but recent adequate markers and/or strategies to study and promote this important goal are described. A myriad of compounds with protective properties in cell cultures and animal models yield to few treatments in clinical practice. At present, markers of neuronal vitality, disease modifying effects and long term clinical stability are the elements searched for in clinical trials. This review highlights new strategies to monitor patients with PD. Currently, neuroprotection in subjects has not been solidly achieved for selegiline and pramipexole; however, a recent rasagiline trial design is showing new indications of disease course modifying effects. In neurological practice, it is of utmost importance to take into account the potential neuroprotection exerted by a treatment in conjunction with its symptomatic efficacy. PMID:22131943

Medical management of Parkinson's disease: focus on neuroprotection.

PubMed

Boll, Marie-Catherine; Alcaraz-Zubeldia, Mireya; Rios, Camilo

2011-06-01

Neuroprotection refers to the protection of neurons from excitotoxicity, oxidative stress and apoptosis as principal mechanisms of cell loss in a variety of diseases of the central nervous system. Our interest in Parkinson's disease (PD) treatment is focused on drugs with neuroprotective properties in preclinical experiments and evidence-based efficacy in human subjects. To this date, neuroprotection has never been solidly proven in clinical trials but recent adequate markers and/or strategies to study and promote this important goal are described. A myriad of compounds with protective properties in cell cultures and animal models yield to few treatments in clinical practice. At present, markers of neuronal vitality, disease modifying effects and long term clinical stability are the elements searched for in clinical trials. This review highlights new strategies to monitor patients with PD. Currently, neuroprotection in subjects has not been solidly achieved for selegiline and pramipexole; however, a recent rasagiline trial design is showing new indications of disease course modifying effects. In neurological practice, it is of utmost importance to take into account the potential neuroprotection exerted by a treatment in conjunction with its symptomatic efficacy.

Anti-TNF-A therapy about infliximab and adalimamab for the effectiveness in ulcerative colitis compared with conventional therapy: a meta-analysis.

PubMed

Zhou, Zheng; Dai, Cong; Liu, Wei-Xin

2015-01-01

TNF-α has an important role in the pathogenesis of ulcerative colitis (UC). It seems that anti-TNF-α therapy is beneficial in the treatment of UC. The aim was to assess the effectiveness of Infliximab and Adalimamab with UC compared with conventional therapy. The Pubmed and Embase databases were searched for studies investigating the efficacy of infliximab and adalimumab on UC. Infliximab had a statistically significant effects in induction of clinical response (RR = 1.67; 95% CI 1.12 to 2.50) of UC compared with conventional therapy, but those had not a statistically significant effects in clinical remission (RR = 1.63; 95% CI 0.84 to 3.18) and reduction of colectomy rate (RR = 0.54; 95% CI 0.26 to 1.12) of UC. And adalimumab had a statistically significant effects in induction of clinical remission (RR = 1.82; 95% CI 1.24 to 2.67) and clinical response (RR = 1.36; 95% CI 1.13 to 1.64) of UC compared with conventional therapy. Our meta-analyses suggested that Infliximab had a statistically significant effects in induction of clinical response of UC compared with conventional therapy and adalimumab had a statistically significant effects in induction of clinical remission and clinical response of UC compared with conventional therapy.

Anti-TNF-A Therapy about Infliximab and Adalimamab for the Effectiveness in Ulcerative Colitis Compared with Conventional Therapy: A Meta-Analysis.

PubMed

Zhou, Zheng; Dai, Cong; Liu, Wei-xin

2015-06-01

TNF-α has an important role in the pathogenesis of ulcerative colitis (UC). It seems that anti-TNF-α therapy is beneficial in the treatment of UC. The aim was to assess the effectiveness of Infliximab and Adalimamab with UC compared with con- ventional therapy. The Pubmed and Embase databases were searched for studies investigating the efficacy of infliximab and adalimumab on UC. Infliximab had a statistically significant effects in induction of clinical response (RR = 1.67; 95% CI 1.12 to 2.50) of UC compared with conventional therapy, but those had not a statistically significant effects in clinical remission (RR = 1.63; 95% CI 0.84 to 3.18) and reduction of colectomy rate (RR = 0.54; 95% CI 0.26 to 1.12) of UC. And adalimumab had a statistically significant effects in induction of clinical remission (RR =1.82; 95% CI 1.24 to 2.67) and clinical response (RR =1.36; 95% CI 1.13 to 1.64) of UC compared with conventional therapy. Our meta-analyses suggested that Infliximab had a statistically significant effects in induction of clinical response of UC compared with conventional therapy and adalimumab had a statistically significant effects in induction of clinical remission and clinical response of UC compared with conventional therapy.

Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers.

PubMed

Goldstein, Judith E; Jackson, Mary Lou; Fox, Sandra M; Deremeik, James T; Massof, Robert W

2015-07-01

To facilitate comparative clinical outcome research in low vision rehabilitation, we must use patient-centered measurements that reflect clinically meaningful changes in visual ability. To quantify the effects of currently provided low vision rehabilitation (LVR) on patients who present for outpatient LVR services in the United States. Prospective, observational study of new patients seeking outpatient LVR services. From April 2008 through May 2011, 779 patients from 28 clinical centers in the United States were enrolled in the Low Vision Rehabilitation Outcomes Study. The Activity Inventory, a visual function questionnaire, was administered to measure overall visual ability and visual ability in 4 functional domains (reading, mobility, visual motor function, and visual information processing) at baseline and 6 to 9 months after usual LVR care. The Geriatric Depression Scale, Telephone Interview for Cognitive Status, and Medical Outcomes Study 36-Item Short-Form Health Survey physical functioning questionnaires were also administered to measure patients' psychological, cognitive, and physical health states, respectively, and clinical findings of patients were provided by study centers. Mean changes in the study population and minimum clinically important differences in the individual in overall visual ability and in visual ability in 4 functional domains as measured by the Activity Inventory. Baseline and post-rehabilitation measures were obtained for 468 patients. Minimum clinically important differences (95% CIs) were observed in nearly half (47% [95% CI, 44%-50%]) of patients in overall visual ability. The prevalence rates of patients with minimum clinically important differences in visual ability in functional domains were reading (44% [95% CI, 42%-48%]), visual motor function (38% [95% CI, 36%-42%]), visual information processing (33% [95% CI, 31%-37%]), and mobility (27% [95% CI, 25%-31%]). The largest average effect size (Cohen d = 0.87) for the population was observed in overall visual ability. Age (P = .006) was an independent predictor of changes in overall visual ability, and logMAR visual acuity (P = .002) was predictive of changes in visual information processing. Forty-four to fifty percent of patients presenting for outpatient LVR show clinically meaningful differences in overall visual ability after LVR, and the average effect sizes in overall visual ability are large, close to 1 SD.

The temporal pattern of stimulation may be important to the mechanism of deep brain stimulation

PubMed Central

Hess, Christopher W.; Vaillancourt, David E.; Okun, Michael S.

2013-01-01

Deep brain stimulation (DBS) has emerged as an important and potentially powerful treatment option for the management of carefully selected patients with advanced Parkinson's disease (PD) who are not adequately controlled by standard medication therapy. Though considerable advances have been made, the mechanisms underlying the therapeutic effects of DBS remain unclear despite its clinical efficacy. It is now widely held that both excitation and inhibition can occur secondary to stimulation, and it is suspected that abnormal synchronized oscillations may also be important in the mechanism of DBS. Other potentially important processes, including blood flow changes, local and upstream neurogenesis, and the modulation of neurotransmitters through stimulation of bordering astrocytes are also being investigated. Recent research has suggested that the temporal pattern of DBS stimulation is also an important variable in DBS neuromodulation, yet the extent of its influence on DBS efficacy has yet to be determined. As high stimulation frequency alone does not appear to be sufficient for optimal symptom suppression, attention to stimulation pattern might lead to more effective symptom control and reduced side effects, possibly at a lower frequency. Stimulation pattern may be potentially amenable to therapeutic modulation and its role in the clinical efficacy of DBS should be addressed through further focus and research. PMID:23399890

Ibogaine-associated cardiac arrest and death: case report and review of the literature.

PubMed

Meisner, Jessica A; Wilcox, Susan R; Richards, Jeremy B

2016-04-01

A naturally occurring hallucinogenic plant alkaloid, ibogaine has been used as an adjuvant for opiate withdrawal for the past 50 years. In the setting of an escalating nationwide opiate epidemic, use of substances such as ibogaine may also increase. Therefore, familiarity with the mechanisms and potential adverse effects of ibogaine is important for clinicians. We present the case report of a man whose use of ibogaine resulted in cardiac arrest and death, complemented by a review of the literature regarding ibogaine's clinical effects. A 40-year-old man who used ibogaine for symptoms of heroin withdrawal suffered acute cardiac arrest leading to cerebral edema and brain death. His presentation was consistent with ibogaine-induced cardiotoxicity and ibogaine-induced cardiac arrest, and a review of the literature regarding the history, mechanisms, risks and clinical outcomes associated with ibogaine is presented. The case presented underscores the significant potential clinical risks of ibogaine. It is important the healthcare community be aware of the possible effects of ibogaine such that clinicians can provide informed counseling to their patients regarding the risks of attempting detoxification with ibogaine.

Ibogaine-associated cardiac arrest and death: case report and review of the literature

PubMed Central

Meisner, Jessica A.; Wilcox, Susan R.; Richards, Jeremy B.

2016-01-01

A naturally occurring hallucinogenic plant alkaloid, ibogaine has been used as an adjuvant for opiate withdrawal for the past 50 years. In the setting of an escalating nationwide opiate epidemic, use of substances such as ibogaine may also increase. Therefore, familiarity with the mechanisms and potential adverse effects of ibogaine is important for clinicians. We present the case report of a man whose use of ibogaine resulted in cardiac arrest and death, complemented by a review of the literature regarding ibogaine’s clinical effects. A 40-year-old man who used ibogaine for symptoms of heroin withdrawal suffered acute cardiac arrest leading to cerebral edema and brain death. His presentation was consistent with ibogaine-induced cardiotoxicity and ibogaine-induced cardiac arrest, and a review of the literature regarding the history, mechanisms, risks and clinical outcomes associated with ibogaine is presented. The case presented underscores the significant potential clinical risks of ibogaine. It is important the healthcare community be aware of the possible effects of ibogaine such that clinicians can provide informed counseling to their patients regarding the risks of attempting detoxification with ibogaine. PMID:27141291

Incorporating Stroke and Bleeding Risk Stratification Tools into Atrial Fibrillation Management Making Sense of the Alphabet Soup.

PubMed

Deering, Thomas F

2017-01-01

Atrial fibrillation (AF) is a common arrhythmia managed by many physicians in a variety of clinical settings. One of the most important clinical decisions related to effective AF management centers upon the need to perform accurate thromboembolic risk stratification followed by effective management decisions that align with established guidelines. This manuscript will review the present state of the art and provide guidance to physicians to enhance patient outcomes.

Response Expectancy and the Placebo Effect.

PubMed

Kirsch, Irving

2018-01-01

In this chapter, I review basic tenets of response expectancy theory (Kirsch, 1985), beginning with the important distinction between response expectancies and stimulus expectancies. Although both can affect experience, the effects of response expectancies are stronger and more resistant to extinction than those of stimulus expectancies. Further, response expectancies are especially important to understanding placebo effects. The response expectancy framework is consistent with and has been amplified by the Bayesian model of predictive coding. Clinical implications of these phenomena are exemplified. © 2018 Elsevier Inc. All rights reserved.

Food-drug interactions.

PubMed

Schmidt, Lars E; Dalhoff, Kim

2002-01-01

Interactions between food and drugs may inadvertently reduce or increase the drug effect. The majority of clinically relevant food-drug interactions are caused by food-induced changes in the bioavailability of the drug. Since the bioavailability and clinical effect of most drugs are correlated, the bioavailability is an important pharmacokinetic effect parameter. However, in order to evaluate the clinical relevance of a food-drug interaction, the impact of food intake on the clinical effect of the drug has to be quantified as well. As a result of quality review in healthcare systems, healthcare providers are increasingly required to develop methods for identifying and preventing adverse food-drug interactions. In this review of original literature, we have tried to provide both pharmacokinetic and clinical effect parameters of clinically relevant food-drug interactions. The most important interactions are those associated with a high risk of treatment failure arising from a significantly reduced bioavailability in the fed state. Such interactions are frequently caused by chelation with components in food (as occurs with alendronic acid, clodronic acid, didanosine, etidronic acid, penicillamine and tetracycline) or dairy products (ciprofloxacin and norfloxacin), or by other direct interactions between the drug and certain food components (avitriptan, indinavir, itraconazole solution, levodopa, melphalan, mercaptopurine and perindopril). In addition, the physiological response to food intake, in particular gastric acid secretion, may reduce the bioavailability of certain drugs (ampicillin, azithromycin capsules, didanosine, erythromycin stearate or enteric coated, and isoniazid). For other drugs, concomitant food intake may result in an increase in drug bioavailability either because of a food-induced increase in drug solubility (albendazole, atovaquone, griseofulvin, isotretinoin, lovastatin, mefloquine, saquinavir and tacrolimus) or because of the secretion of gastric acid (itraconazole capsules) or bile (griseofulvin and halofantrine) in response to food intake. For most drugs, such an increase results in a desired increase in drug effect, but in others it may result in serious toxicity (halofantrine).

Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

PubMed Central

Jones, Paul W; Rennard, Stephen; Tabberer, Maggie; Riley, John H; Vahdati-Bolouri, Mitra; Barnes, Neil C

2016-01-01

One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs) in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique) the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of the study population. For the practising clinician, the most important consideration is the importance of individualization of treatment (and of treatment goals). To inform such treatment, clinicians need to critically review PRO data. The hope is that the questions posed here will help to build a framework for this critical review. PMID:27994447

Interpreting patient-reported outcomes from clinical trials in COPD: a discussion.

PubMed

Jones, Paul W; Rennard, Stephen; Tabberer, Maggie; Riley, John H; Vahdati-Bolouri, Mitra; Barnes, Neil C

2016-01-01

One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs) in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique) the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George's Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of the study population. For the practising clinician, the most important consideration is the importance of individualization of treatment (and of treatment goals). To inform such treatment, clinicians need to critically review PRO data. The hope is that the questions posed here will help to build a framework for this critical review.

A qualitative evaluation of a Local Professional Network programme "Baby Teeth DO Matter".

PubMed

Brocklehurst, P; Bridgman, C; Davies, G

2013-12-01

The objective of this study was to use a qualitative approach to examine the perceptions of dentists who led a health promotion programme entitled "Baby Teeth DO Matter". Semi-structured interviews were undertaken with a variety of participants in a health promotional programme facilitated by a shadow Local Professional Network. These were then recorded and transcribed verbatim. The transcripts were line numbered and subjected to thematic analysis to develop a coding frame. Overarching themes were developed from the coded transcripts by organising them into clusters based on the similarity of their meaning and checked against the coded extracts and the raw data. General Dental Practice. General Dental Practitioners. A Greater Manchester-wide prevention programme entitled "Baby teeth DO Matter". To determine the perceptions of involved clinicians and whether "clinically owned and clinically led" services add value. Eight codes were generated: "Success of the project", "Down-stream to up-stream", "Importance of clinically led and clinically owned", "Keeping the approach simple", "Importance of networking", "Importance of Dental Public Health", "Importance of task and finish" and "Threats to the future of the Local Professional Network". These were organised into three over-arching themes. "Clinically Led and Clinically Owned" projects appear to empower local practitioners and add value. They encourage community-facing practitioners, build capacity and develop personal skills;--all in accordance with the fundamental principles of the Ottawa Charter. Distributed leadership was seen to be effective and Dental Public Health input, "Task and Finishing", resources and clarity of communication were all considered to be of critical importance.

Role of mixed ion channel effects in the cardiovascular safety assessment of the novel anti-MRSA fluoroquinolone JNJ-Q2.

PubMed

Eichenbaum, G; Pugsley, M K; Gallacher, D J; Towart, R; McIntyre, G; Shukla, U; Davenport, J M; Lu, H R; Rohrbacher, J; Hillsamer, V

2012-07-01

JNJ-Q2, a novel broad-spectrum fluoroquinolone with anti-methicillin-resistant Staphylococcus aureus activity, was evaluated in a comprehensive set of non-clinical and clinical cardiovascular safety studies. The effect of JNJ-Q2 on different cardiovascular parameters was compared with that of moxifloxacin, sparfloxacin and ofloxacin. Through comparisons with these well-known fluoroquinolones, the importance of effects on compensatory ion channels to the cardiovascular safety of JNJ-Q2 was investigated. JNJ-Q2 and comparator fluoroquinolones were evaluated in the following models/test systems: hERG-transfected HEK293 cells sodium channel-transfected CHO cells, guinea pig right atria, arterially perfused rabbit left ventricular wedge preparations and in vivo studies in anaesthetized guinea pigs, anaesthetized and conscious telemetered dogs, and a thorough QT study in humans. The trend for effects of JNJ-Q2 on Tp-Te, QT, QRS and PR intervals in the non-clinical models and the plateau in QTc with increasing plasma concentration in humans are consistent with offsetting sodium and calcium channel activities that were observed in the non-clinical studies. These mixed ion channel activities result in the less pronounced or comparable increase in QTc interval for JNJ-Q2 compared with moxifloxacin and sparfloxacin despite its greater in vitro inhibition of I(Kr). Based on the non-clinical and clinical cardiovascular safety assessment, JNJ-Q2 has a safe cardiovascular profile for administration in humans with comparable or reduced potential to prolong QT intervals, compared with moxifloxacin. The results demonstrate the importance of compensatory sodium and calcium channel activity in offsetting potassium channel activity for compounds with a fluoroquinolone core. © 2012 Janssen Pharmaceutical Companies of Johnson & Johnson. British Journal of Pharmacology © 2012 The British Pharmacological Society.

Importance of placebo effect in cough clinical trials.

PubMed

Eccles, Ron

2010-01-01

Cough is a unique symptom because, unlike sneeze and other symptoms, it can be under voluntary control and this complicates clinical trials on cough medicines. All over-the-counter cough medicines (OTC) are very effective treatments because of their placebo effect. The placebo effect is enhanced by expectancy related to advertising, brand, packaging, and formulation. This placebo effect creates a problem for the conduct of clinical trials on OTC cough medicines that attempt to demonstrate the efficacy of a pharmacological agent above that of any placebo effect. Up to 85% of the efficacy of some cough medicines can be attributed to a placebo effect. The placebo effect apparent in clinical trials consists of several components: natural recovery, regression of cough response toward mean, demulcent effect, effect of sweetness, voluntary control, and effects related to expectancy and meaning of the treatment. The placebo effect has been studied most in the pain model, and placebo analgesia is reported to depend on the activation of endogenous opioid systems in the brain; this model may be applicable to cough. A balanced placebo design may help to control for the placebo effect, but this trial design may not be acceptable due to deception of patients. The placebo effect in clinical trials may be controlled by use of a crossover design, where feasible, and the changes in the magnitude of the placebo effect in this study design are discussed.

Epidemiology and control of schistosomiasis: present situation and priorities for further research. Scientific Working Group on Schistosomiasis.

PubMed

1978-01-01

The article highlights specific aspects of the epidemiology of schistosomiasis where insufficient data are available on which to base appropriate control strategies. Emphasis is placed on the part that immunological techniques might play in improving the baseline epidemiological data. A study of acquired resistance to the disease is also important in relation to epidemiology and control. The clinical manifestations of the disease vary in different areas and further study of the relation between the clinical and pathological manifestations are therefore required. In relation to the intermediate host, the main priority for research concerns the definition of the location and time-patterns of transmission foci within any particular area: variations in transmission are of particular importance in relation to man-made water resources. Although chemotherapy will play an increasing role in control, its importance will depend on local conditions: coordinated and standardized trials are required of chemotherapeutic agents in different regions and in various defined groups of subjects. The effects of chemotherapy on immunity to reinfection and on immunopathology also require study. With all types of snail control-chemical, ecological, and biological-cost-effectiveness aspects are important. With chemicals, it is important to bear in mind other possible effects on the environment. In the field of water supplies and sanitation, several aspects are important in relation to schistosomiasis transmission and community involvement should be encouraged.

An Analysis of the Effectiveness of University Counselling Services

ERIC Educational Resources Information Center

Murray, Aja L.; McKenzie, Karen; Murray, Kara R.; Richelieu, Marc

2016-01-01

It is important to demonstrate replicable evidence of the effectiveness of counselling procedures. The study aimed to contribute to the currently limited evidence base examining the effectiveness of university student counselling in the UK. Information on therapeutic outcome [based on Clinical Outcomes in Routine Evaluation-Outcome Measure…

Developing performance indicators for clinical governance in dimensions of risk management and clinical effectiveness.

PubMed

Azami-Aghdash, Saber; Tabrizi, Jafar Sadegh; Sadeghi-Bazargani, Homayoun; Hajebrahimi, Sakineh; Naghavi-Behzad, Mohammad

2015-04-01

This study has been designed and conducted to develop domestic indicators for evaluating the performance of clinical governance in dimensions of risk management and clinical effectiveness. This study implemented a 5-stage process including conducting a comprehensive literature review, expert panel (∼ 1000 h per person per session, 11 experts), semi-structured interviews, a 2-round Delphi study (33 experts were in attendance) and a final expert panel (8 experts were in attendance). East Azerbaijan-Iran Province. Fifty-six specialists and experts in different fields of medical sciences. Importance and applicability of indicators. Using a thorough literature review, 361 indicators (129 risk management indicators in 4 dimensions and 232 clinical effectiveness indicators in 18 dimensions) were found. After conducting expert panels and interviews, the number of indicators decreased to 168 cases (65 risk management indicators in 4 dimensions and 103 clinical effectiveness indicators in 12 dimensions). Two rounds of Delphi identified four indicators that were omitted. The members of the final expert panel agreed on 113 indicators (43 risk management indicators in 4 dimensions and 70 clinical effectiveness indicators in 11 dimensions). In this study, indicators for assessing clinical governance in domains of risk management and clinical effectiveness were designed that can be used by policy-makers and other authorities for improving the quality of services and evaluating the performance of clinical governance. Those indicators can be used with slight modifications in other countries having healthcare systems similar to that of Iran. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Preclinical to Clinical Translation of Studies of Transcranial Direct-Current Stimulation in the Treatment of Epilepsy: A Systematic Review

PubMed Central

Regner, Gabriela G.; Pereira, Patrícia; Leffa, Douglas T.; de Oliveira, Carla; Vercelino, Rafael; Fregni, Felipe; Torres, Iraci L. S.

2018-01-01

Epilepsy is a chronic brain syndrome characterized by recurrent seizures resulting from excessive neuronal discharges. Despite the development of various new antiepileptic drugs, many patients are refractory to treatment and report side effects. Non-invasive methods of brain stimulation, such as transcranial direct current stimulation (tDCS), have been tested as alternative approaches to directly modulate the excitability of epileptogenic neural circuits. Although some pilot and initial clinical studies have shown positive results, there is still uncertainty regarding the next steps of investigation in this field. Therefore, we reviewed preclinical and clinical studies using the following framework: (1) preclinical studies that have been successfully translated to clinical studies, (2) preclinical studies that have failed to be translated to clinical studies, and (3) clinical findings that were not previously tested in preclinical studies. We searched PubMed, Web of Science, Embase, and SciELO (2002–2017) using the keywords “tDCS,” “epilepsy,” “clinical trials,” and “animal models.” Our initial search resulted in 64 articles. After applying inclusion and exclusion criteria, we screened 17 full-text articles to extract findings about the efficacy of tDCS, with respect to the therapeutic framework used and the resulting reduction in seizures and epileptiform patterns. We found that few preclinical findings have been translated into clinical research (number of sessions and effects on seizure frequency) and that most findings have not been tested clinically (effects of tDCS on status epilepticus and absence epilepsy, neuroprotective effects in the hippocampus, and combined use with specific medications). Finally, considering that clinical studies on tDCS have been conducted for several epileptic syndromes, most were not previously tested in preclinical studies (Rasmussen's encephalitis, drug resistant epilepsy, and hippocampal sclerosis-induced epilepsy). Overall, most studies report positive findings. However, it is important to underscore that a successful preclinical study may not indicate success in a clinical study, considering the differences highlighted herein. Although most studies report significant findings, there are still important insights from preclinical work that must be tested clinically. Understanding these factors may improve the evidence for the potential use of this technique as a clinical tool in the treatment of epilepsy. PMID:29623027

Smoking Cessation Advice: Knowledge, Attitude, and Practice among Clinical Dental Students’

PubMed Central

Prabhu, Allama; Jain, Jayesh Kumar; Sakeenabhi, B.; Kumar, P. G. Naveen; Imranulla, Mohamed; Ragher, Mallikarjuna

2017-01-01

Background: Smoking is the single most important public health challenge facing the National Health Service. The detrimental effects on the general health of tobacco smoking are well documented. Smoking is a primary risk factor for oral cancer and many oral diseases. Dental professional scan plays an important role in preventing adverse health effects by promoting smoking cessation. Objective: To assess the knowledge, attitude, and practice among clinical dental students in giving smoking cessation advice and to explore the barriers to this activity. Materials and Methods: A total of 262 clinical dental trainee of two dental colleges (College of Dental Sciences and Bapuji Dental College) of Davangere city were included in the survey. A self-administered questionnaire was administered to assess the knowledge, attitude, and practice toward Tobacco Cessation Advise. Results: Among the 262 participants in the study, around 51% said they know about Nicotine Replacement Therapy, and among them, only 4.6% were aware of the options available in the market. When asked about 5A's of tobacco cessation, only 35.5% were aware of it. Similarly, when asked about 5R's of tobacco cessation, 48.5% were unaware of it. Conclusions: The respondents did not have sufficient knowledge regarding tobacco cessation advice. With patient's disinterest and lack of time being quoted as the important barriers in providing tobacco cessation advice, it is highly recommended that there is need to incorporate few chapters on tobacco, its effect and cessation of habit in the undergraduate dental curriculum with simultaneous application of the same in clinical practice. PMID:29284949

Quality improvement in New Zealand healthcare. Part 3: achieving effective care through clinical audit.

PubMed

Seddon, Mary; Buchanan, John

2006-08-04

In this third article in the Series on quality improvement, we examine the effectiveness of dimension of healthcare quality. To satisfy this dimension, two equally important facets must be attended to. First the best available evidence must be sought through research, and second that evidence must be applied--this second function is the domain of quality improvement activities generally and clinical audit in particular. Clinical audit is one of the main tools to establish whether the best evidence is being used in practice, as it compares actual practice to a standard of practice. Clinical audit identifies any gaps between what is done and what should be done, and rectifies any deficiencies in the actual processes of care. In this article, the steps involved in a clinical audit, how it is different to research, and the question of whether clinical audit requires ethical approval are explored.

Building Networks for Global Clinical Research: The Basics.

PubMed

Shearer, David W; Volberding, Paul A; Schemitsch, Emil H; Cook, Gillian E; Slobogean, Gerard P; Morshed, Saam

2015-12-01

Over the last several decades, interest in global health across all fields of medicine, including orthopaedic surgery, has grown markedly. Cross-national collaborations are an effective means of conducting high-quality clinical research and offer many advantages over single-center investigations. Successful collaboration requires a well-designed research protocol, development of an effective team structure, and the funding to ensure the project is sustained to completion. Equally important, investigators must consider the social, linguistic, and cultural context in which the study is being undertaken. Although randomized clinical trials are the highest level of evidence, study designs may have to be adapted to accommodate available resources, expertise, and local contextual factors. With appropriate planning, these collaborative endeavors can generate changes in clinical practice and positively impact health policy.

Neuroprotection as a Therapeutic Target for Diabetic Retinopathy.

PubMed

Hernández, Cristina; Dal Monte, Massimo; Simó, Rafael; Casini, Giovanni

2016-01-01

Diabetic retinopathy (DR) is a multifactorial progressive disease of the retina and a leading cause of vision loss. DR has long been regarded as a vascular disorder, although neuronal death and visual impairment appear before vascular lesions, suggesting an important role played by neurodegeneration in DR and the appropriateness of neuroprotective strategies. Upregulation of vascular endothelial growth factor (VEGF), the main target of current therapies, is likely to be one of the first responses to retinal hyperglycemic stress and VEGF may represent an important survival factor in early phases of DR. Of central importance for clinical trials is the detection of retinal neurodegeneration in the clinical setting, and spectral domain optical coherence tomography seems the most indicated technique. Many substances have been tested in animal studies for their neuroprotective properties and for possible use in humans. Perhaps, the most intriguing perspective is the use of endogenous neuroprotective substances or nutraceuticals. Together, the data point to the central role of neurodegeneration in the pathogenesis of DR and indicate neuroprotection as an effective strategy for treating this disease. However, clinical trials to determine not only the effectiveness and safety but also the compliance of a noninvasive route of drug administration are needed.

Neuroprotection as a Therapeutic Target for Diabetic Retinopathy

PubMed Central

Hernández, Cristina; Simó, Rafael

2016-01-01

Diabetic retinopathy (DR) is a multifactorial progressive disease of the retina and a leading cause of vision loss. DR has long been regarded as a vascular disorder, although neuronal death and visual impairment appear before vascular lesions, suggesting an important role played by neurodegeneration in DR and the appropriateness of neuroprotective strategies. Upregulation of vascular endothelial growth factor (VEGF), the main target of current therapies, is likely to be one of the first responses to retinal hyperglycemic stress and VEGF may represent an important survival factor in early phases of DR. Of central importance for clinical trials is the detection of retinal neurodegeneration in the clinical setting, and spectral domain optical coherence tomography seems the most indicated technique. Many substances have been tested in animal studies for their neuroprotective properties and for possible use in humans. Perhaps, the most intriguing perspective is the use of endogenous neuroprotective substances or nutraceuticals. Together, the data point to the central role of neurodegeneration in the pathogenesis of DR and indicate neuroprotection as an effective strategy for treating this disease. However, clinical trials to determine not only the effectiveness and safety but also the compliance of a noninvasive route of drug administration are needed. PMID:27123463

Development and psychometric testing of the Clinical Learning Organisational Culture Survey (CLOCS).

PubMed

Henderson, Amanda; Creedy, Debra; Boorman, Rhonda; Cooke, Marie; Walker, Rachel

2010-10-01

This paper describes the development and psychometric testing of the Clinical Learning Organisational Culture Survey (CLOCS) that measures prevailing beliefs and assumptions important for learning to occur in the workplace. Items from a tool that measured motivation in workplace learning were adapted to the nursing practice context. The tool was tested in the clinical setting, and then further modified to enhance face and content validity. Registered nurses (329) across three major Australian health facilities were surveyed between June 2007 and September 2007. An exploratory factor analysis identified five concepts--recognition, dissatisfaction, affiliation, accomplishment, and influence. VALIDITY AND RELIABILITY: Internal consistency measures of reliability revealed that four concepts had good internal consistency: recognition (alpha=.914), dissatisfaction (alpha=.771), affiliation (alpha=.801), accomplishment (alpha=.664), but less so for influence (alpha=.529). This tool effectively measures recognition, affiliation and accomplishment--three concepts important for learning in practice situations, as well as dissatisfied staff across all these domains. Testing of additional influence items identify that this concept is difficult to delineate. The CLOCS can effectively inform leaders about concepts inherent in the culture important for maximising learning by staff. Crown Copyright © 2009. Published by Elsevier Ltd. All rights reserved.

Integrating Bioethics into Clinical and Translational Science Research: A Roadmap

PubMed Central

Shapiro, Robyn S.; Layde, Peter M.

2008-01-01

Abstract Recent initiatives to improve human health emphasize the need to effectively and appropriately translate new knowledge gleaned from basic biomedical and behavioral research to clinical and community application. To maximize the beneficial impact of scientific advances in clinical practice and community health, and to guard against potential deleterious medical and societal consequences of such advances, incorporation of bioethics at each stage of clinical and translational science research is essential. At the earliest stage, bioethics input is critical to address issues such as whether to limit certain areas of scientific inquiry. Subsequently, bioethics input is important to assure not only that human subjects trials are conducted and reported responsibly, but also that results are incorporated into clinical and community practices in a way that promotes and protects bioethical principles. At the final stage of clinical and translational science research, bioethics helps to identify the need and approach for refining clinical practices when safety or other concerns arise. The framework we present depicts how bioethics interfaces with each stage of clinical and translational science research, and suggests an important research agenda for systematically and comprehensively assuring bioethics input into clinical and translational science initiatives. PMID:20443821

Vertical integration of biochemistry and clinical medicine using a near-peer learning model.

PubMed

Gallan, Alexander J; Offner, Gwynneth D; Symes, Karen

2016-11-12

Vertical integration has been extensively implemented across medical school curricula but has not been widely attempted in the field of biochemistry. We describe a novel curricular innovation in which a near-peer learning model was used to implement vertical integration in our medical school biochemistry course. Senior medical students developed and facilitated a case-based small group session for first year biochemistry students. Students were surveyed before and after the session on their attitudes about biochemistry, as well as the effectiveness of the session. Prior to the session, the students believed biochemistry was more important to understanding the basic science of medicine than it was to understanding clinical medicine or becoming a good physician. The session improved students' attitudes about the importance of biochemistry in clinical medicine, and after the session they now believe that understanding biochemistry is equally important to the basic sciences as clinical medicine. Students would like more sessions and believe the senior student facilitators were knowledgeable and effective teachers. The facilitators believe they improved their teaching skills. This novel combination of near-peer learning and vertical integration in biochemistry provided great benefit to both first year and senior medical students, and can serve as a model for other institutions. © 2016 by The International Union of Biochemistry and Molecular Biology, 44(6):507-516, 2016. © 2016 The International Union of Biochemistry and Molecular Biology.

Attitudes towards the Infection Prevention and Control Nurse: an interview study.

PubMed

Ward, Deborah J

2012-07-01

A study was undertaken involving nursing students and nurse mentors to investigate the experiences and learning needs of nursing students in relation to infection prevention. One of the objectives was to consider the views of both nursing students and mentors towards the Infection Prevention and Control Nurse (IPCN) as an important staff member in infection prevention and control. Infection prevention and control is a national and international priority but compliance with precautions can be low. One reason for this is staff attitudes. Infection Prevention and Control Nurses have an important role to play in the management of patient care through clinical staff and it is therefore important that they are seen as approachable and effective in their role. Using a qualitative approach, data were obtained through semistructured interviews with 31 nursing students and 32 nurse mentors. Interviews were recorded, transcribed and analysed using framework analysis. Three themes emerged: attitudes towards the IPCN, effects of the presence of the IPCN and preferred qualities in IPCNs. Areas for future research are identified and recommendations made to address areas where attitudes may affect both clinical practice and the education of nursing students in clinical placements. Nurse specialists or practitioners, who are often seen within a management role, need to consider how they work with clinical staff in order to foster more collaborative relationships. © 2012 Blackwell Publishing Ltd.

What is the effect of surgery on the quality of life of the adolescent with adolescent idiopathic scoliosis? A review and statistical analysis of the literature.

PubMed

Rushton, Paul R P; Grevitt, Michael P

2013-04-20

Review and statistical analysis of studies evaluating the effect of surgery on the health-related quality of life of adolescents with adolescent idiopathic scoliosis, using Scoliosis Research Society (SRS) outcomes. Apply published minimum clinical important differences (MCID) values for the SRS22r questionnaire to the literature to identify what areas of health-related quality of life are consistently affected by surgery and whether changes are clinically meaningful. The interpretation of published studies using the SRS outcomes has been limited by the lack of MCID values for the questionnaire domains. The recent publication of these data allows the clinical importance of any changes in these studies to be examined for the first time. A literature search was undertaken to locate suitable studies that were then analyzed. Statistically significant differences from baseline to 2 years postoperatively were ascertained by narratively reporting the analyses within included studies. When possible, clinically significant changes were assessed using 95% confidence intervals for the change in mean domain score. If the lower bound of the confidence intervals for the change exceeded the MCID for that domain, the change was considered clinically significant. The numbers of cohorts available for the different analyses varied (5-16). Eighty-one percent and 94% of included cohorts experienced statistically significant improvements in pain and self-image domains. In terms of clinical significance, it was only self-image that regularly improved by more than MCID, doing so in 4 of 5 included cohorts (80%) compared with 1 of 12 cohorts (8%) for pain. No clinically relevant changes occurred in mental health or activity domains. Evidence suggests that surgery can lead to clinically important improvement in patient self-image. Surgeons and patients should be aware of the limited evidence for improvements in domains other than self-image after surgery. Surgical decision-making will also be influenced by the natural history of adolescent idiopathic scoliosis.

The Influence of Context on Residents' Evaluations: Effects of Priming on Clinical Judgment and Affect

ERIC Educational Resources Information Center

Teunissen, P. W.; Stapel, D. A.; Scheele, F.; Scherpbier, A. J. J. A.; Boor, K.; van Diemen-Steenvoorde, J. A. A. M.; van der Vleuten, C. P. M.

2009-01-01

Different lines of research have suggested that context is important in acting and learning in the clinical workplace. It is not clear how contextual information influences residents' constructions of the situations in which they participate. The category accessibility paradigm from social psychology appears to offer an interesting perspective for…

Learning on clinical placement: the experience of six Australian student nurses.

PubMed

Nolan, C A

1998-11-01

Concerns about the adequacy of clinical education in nursing courses in Australia have escalated since the transfer of pre-registration nursing education into the tertiary sector. This descriptive, interpretative study, informed by the tradition of critical social science, sought to understand the clinical learning experiences of undergraduate nursing students. At the same time, it fostered an active participation of students in their own learning. Daily post-clinical conferences with the students were taped and transcribed verbatim to provide data for the study. Additional data was collected from informal discussions and observations of the students during the placement. Analysis revealed three main categories, which reflected the students' experiences. These included: (1) I don't belong; (2) doing and practising: progress at last; and (3) transitions in thinking. Feeling part of the team was closely linked to the opportunity to learn, emphasizing the important role not only of educators but also clinicians in undergraduate learning on clinical placement. Though the findings reflect age-long problems associated with student learning in the clinical field, it serves to remind all nurses of the importance they play in the learning process. This study reflects the importance of effective communication between the health and education sectors and the need to concentrate on strategies which will strengthen this bond.

Observer agreement in the reporting of knee and lumbar spine magnetic resonance (MR) imaging examinations: selectively trained MR radiographers and consultant radiologists compared with an index radiologist.

PubMed

Brealey, S; Piper, K; King, D; Bland, M; Caddick, J; Campbell, P; Gibbon, A; Highland, A; Jenkins, N; Petty, D; Warren, D

2013-10-01

To assess agreement between trained radiographers and consultant radiologists compared with an index radiologist when reporting on magnetic resonance imaging (MRI) examinations of the knee and lumbar spine and to examine the subsequent effect of discordant reports on patient management and outcome. At York Hospital two MR radiographers, two consultant radiologists and an index radiologist reported on a prospective, random sample of 326 MRI examinations. The radiographers reported in clinical practice conditions and the radiologists during clinical practice. An independent consultant radiologist compared these reports with the index radiologist report for agreement. Orthopaedic surgeons then assessed whether the discordance between reports was clinically important. Overall observer agreement with the index radiologist was comparable between observers and ranged from 54% to 58%; for the knee it was 46-57% and for the lumbar spine was 56-66%. There was a very small observed difference of 0.6% (95% CI -11.9 to 13.0) in mean agreement between the radiographers and radiologists (P=0.860). For the knee, lumbar spine and overall, radiographers' discordant reports, when compared with the index radiologist, were less likely to have a clinically important effect on patient outcome than the radiologists' discordant reports. Less than 10% of observer's reports were sufficiently discordant with the index radiologist's reports to be clinically important. Carefully selected MR radiographers with postgraduate education and training reported in clinical practice conditions on specific MRI examinations of the knee and lumbar spine to a level of agreement comparable with non-musculoskeletal consultant radiologists. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Cross-sector sponsorship of research in eosinophilic esophagitis: a collaborative model for rational drug development in rare diseases.

PubMed

Fiorentino, Robert; Liu, Gumei; Pariser, Anne R; Mulberg, Andrew E

2012-09-01

Like many rare diseases, eosinophilic esophagitis (EoE) is a poorly understood disorder, and assessment tools to accurately determine disease activity, remission, and natural history have long been inadequate. Clinical outcome end points able to assess the effectiveness of candidate therapeutic agents in clinical trials have been a particular deficiency and are urgently needed. With no approved therapy available to patients and with the prevalence of EoE on the increase, collaborative approaches to drug development are becoming ever more important. We describe a collaborative effort mobilized across institutions, including both the public and private sectors, that was initiated within the past 18 months expressly to address the need for further clinical research into the cause and treatment of EoE. Collaborators include the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition; the International Gastrointestinal Eosinophilic Researchers; and the US Food and Drug Administration. This effort has resulted in the elucidation of several parameters essential for effective EoE registration trials, including the need for clinically meaningful end points that measure changes in clinical symptoms in addition to the assessment of intraepithelial mucosal eosinophilia. The development and use of biomarkers, particularly in early-phase drug development, have become an important focus for investigations that might reduce clinical reliance on serial invasive monitoring. The concerted efforts described here to develop rational therapeutics and drug development paradigms in EoE also appear to provide a model for effective collaboration in the context of drug development for rare diseases and perhaps more generally for public health initiatives. Published by Mosby, Inc.

The importance of building trust and tailoring interactions when meeting older adults' health literacy needs.

PubMed

Brooks, Charlotte; Ballinger, Claire; Nutbeam, Don; Adams, Jo

2017-11-01

Health literacy is the ability to access, understand and use health information. This study qualitatively explored the views and experiences of older adults with varying health literacy levels who had attended a falls clinic on their overall experience of the falls clinic, access to the service and provider-patient interaction. Individual semi-structured interviews were conducted with nine older adults using a falls clinic in England. Health literacy was assessed using the REALM and NVS-UK. Interviews were audio-recorded, transcribed verbatim and interrogated using interpretative phenomenological analysis (IPA). Two superordinate themes emerged from the analysis: The importance of trust and relationship building to achieve effective communication with older adults; and the importance of tailoring education and healthcare to older adults' individual health literacy needs and preferences. The findings corroborate previous research emphasising the importance of face-to-face communication in responding to older adults' individual health literacy needs. Building trust in the relationship and tailoring communication to older adults' individual attributes and preferred learning styles is essential. Healthcare practitioners and managers should consider how service organisation and communication methods can enhance positive and effective relationships with patients. Improved training could support healthcare providers in meeting patients' personal communication needs. Implications for Rehabilitation Rehabilitation professionals should be aware of their patients' individual health literacy needs and communication/learning preferences. It is important to build relationships and trust with older adults attending rehabilitation services. Further training for rehabilitation professionals could support them in meeting patients' personal communication needs.

Designed experiment evaluation of key variables affecting the cutting performance of rotary instruments.

PubMed

Funkenbusch, Paul D; Rotella, Mario; Ercoli, Carlo

2015-04-01

Laboratory studies of tooth preparation are often performed under a limited range of conditions involving single values for all variables other than the 1 being tested. In contrast, in clinical settings not all variables can be tightly controlled. For example, a new dental rotary cutting instrument may be tested in the laboratory by making a specific cut with a fixed force, but in clinical practice, the instrument must make different cuts with individual dentists applying a range of different forces. Therefore, the broad applicability of laboratory results to diverse clinical conditions is uncertain and the comparison of effects across studies is difficult. The purpose of this study was to examine the effect of 9 process variables on dental cutting in a single experiment, allowing each variable to be robustly tested over a range of values for the other 8 and permitting a direct comparison of the relative importance of each on the cutting process. The effects of 9 key process variables on the efficiency of a simulated dental cutting operation were measured. A fractional factorial experiment was conducted by using a computer-controlled, dedicated testing apparatus to simulate dental cutting procedures and Macor blocks as the cutting substrate. Analysis of Variance (ANOVA) was used to judge the statistical significance (α=.05). Five variables consistently produced large, statistically significant effects (target applied load, cut length, starting rpm, diamond grit size, and cut type), while 4 variables produced relatively small, statistically insignificant effects (number of cooling ports, rotary cutting instrument diameter, disposability, and water flow rate). The control exerted by the dentist, simulated in this study by targeting a specific level of applied force, was the single most important factor affecting cutting efficiency. Cutting efficiency was also significantly affected by factors simulating patient/clinical circumstances as well as hardware choices. These results highlight the importance of local clinical conditions (procedure, dentist) in understanding dental cutting procedures and in designing adequate experimental methodologies for future studies. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Clinically important drug interactions with zopiclone, zolpidem and zaleplon.

PubMed

Hesse, Leah M; von Moltke, Lisa L; Greenblatt, David J

2003-01-01

Insomnia, an inability to initiate or maintain sleep, affects approximately one-third of the American population. Conventional benzodiazepines, such as triazolam and midazolam, were the treatment of choice for short-term insomnia for many years but are associated with adverse effects such as rebound insomnia, withdrawal and dependency. The newer hypnosedatives include zolpidem, zaleplon and zopiclone. These agents may be preferred over conventional benzodiazepines to treat short-term insomnia because they may be less likely to cause significant rebound insomnia or tolerance and are as efficacious as the conventional benzodiazepines. This review aims to summarise the published clinical drug interaction studies involving zolpidem, zaleplon and zopiclone. The pharmacokinetic and pharmacodynamic interactions that may be clinically important are highlighted. Clinical trials have studied potential interactions of zaleplon, zolpidem and zopiclone with the following types of drugs: cytochrome P450 (CYP) inducers (rifampicin), CYP inhibitors (azoles, ritonavir and erythromycin), histamine H(2) receptor antagonists (cimetidine and ranitidine), antidepressants, antipsychotics, antagonists of benzodiazepines and drugs causing sedation. Rifampicin significantly induced the metabolism of the newer hypnosedatives and decreased their sedative effects, indicating that a dose increase of these agents may be necessary when they are administered with rifampicin. Ketoconazole, erythromycin and cimetidine inhibited the metabolism of the newer hypnosedatives and enhanced their sedative effects, suggesting that a dose reduction may be required. Addition of ethanol to treatment with the newer hypnosedatives resulted in additive sedative effects without altering the pharmacokinetic parameters of the drugs. Compared with some of the conventional benzodiazepines, fewer clinically important interactions appear to have been reported in the literature with zaleplon, zolpidem and zopiclone. The fact that these drugs are newer to the market and have not been as extensively studied as the conventional benzodiazepines may be the reason for this. Another explanation may be a difference in CYP metabolism. While triazolam and midazolam are biotransformed almost entirely via CYP3A4, the newer hypnosedatives are biotransformed by several CYP isozymes in addition to CYP3A4, resulting in CYP3A4 inhibitors and inducers having a lesser effect on their biotransformation.

Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography

PubMed Central

Byers, Robert A.; Maiti, Raman; Danby, Simon G.; Pang, Elaine J.; Mitchell, Bethany; Carré, Matt J.; Lewis, Roger; Cork, Michael J.; Matcher, Stephen J.

2018-01-01

Measurement of sub-clinical atopic dermatitis (AD) is important for determining how long therapies should be continued after clinical clearance of visible AD lesions. An important biomarker of sub-clinical AD is epidermal hypertrophy, the structural measures of which often make optical coherence tomography (OCT) challenging due to the lack of a clearly delineated dermal-epidermal junction in AD patients. Alternatively, angiographic OCT measurements of vascular depth and morphology may represent a robust biomarker for quantifying the severity of clinical and sub-clinical AD. To investigate this, angiographic data sets were acquired from 32 patients with a range of AD severities. Deeper vascular layers within skin were found to correlate with increasing clinical severity. Furthermore, for AD patients exhibiting no clinical symptoms, the superficial plexus depth was found to be significantly deeper than healthy patients at both the elbow (p = 0.04) and knee (p<0.001), suggesting that sub-clinical changes in severity can be detected. Furthermore, the morphology of vessels appeared altered in patients with severe AD, with significantly different vessel diameter, length, density and fractal dimension. These metrics provide valuable insight into the sub-clinical severity of the condition, allowing the effects of treatments to be monitored past the point of clinical remission. PMID:29675335

[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.

[Gastritis and gastropathy].

PubMed

Mihály, Emese; Micsik, Tamás; Juhász, Márk; Herszényi, László; Tulassay, Zsolt

2014-01-12

Alterations of the stomach mucosa in response to different adverse effects result in various morphological and clinical symptoms. Gastric mucosa alterations can be classified on the bases of diverse viewpoints. It makes this overview difficult, that identical toxic effects may cause different mucosal changes and different toxic agents may produce similar mucosal appearance. The more accurate understanding of the pathological processes which develop in the stomach mucosa needs reconsideration. The authors make an attempt to define gastritis and gastropathy in order to classify and present their features. Gastritis is a histological definition indicating mucosal inflammation. Acute gastritis is caused by infections. The two most important forms of chronic gastritis are metaplastic atrophic gastritis with an autoimmune origin and Helicobacter pylori inflammation. Gastropathy is the name of different structural alterations of the mucosa. Its most important feature is the paucity of inflammatory signs. Gastropathies can be divided into 4 categories based on the nature of the underlying pathological effect, on its morphological appearance and the way of the development. Differential diagnosis is an important pathological and clinical task because different treatment methods and prognosis.

[Dementia and small vessel diseases of the brain].

PubMed

Damulin, I V

2014-01-01

Clinical and pathogenetic characteristics of dementia caused by small vessel lesions are presented. It is emphasized that this variant of vascular dementia is the most frequent in clinical practice. Clinical examination, accurate assessment of the disease history and using of modern neuroimaging techniques are important for the diagnosis. The drugs that impact on risk factors, including disaggregants, and metabolic drugs (nicergoline) are widely used in the treatment of dementia. These drugs are highly effective and safe.

Real-World Effectiveness and Safety of a Live-Attenuated Herpes Zoster Vaccine: A Comprehensive Review.

PubMed

Ansaldi, Filippo; Trucchi, Cecilia; Alicino, Cristiano; Paganino, Chiara; Orsi, Andrea; Icardi, Giancarlo

2016-07-01

Herpes zoster (HZ) is a common, painful and debilitating disease caused by the reactivation of latent varicella-zoster virus in ganglia. This clinical event occurs more frequently in the elderly and those who are immunocompromised. The most common complication of HZ is post-herpetic neuralgia (PHN) which is responsible for the highest HZ-related burden of illness and is challenging to treat. Due to the important clinical and economic impact of HZ and PHN, and the suboptimal treatments that are currently available, HZ vaccination is an important approach to reduce the burden of illness. Currently, one-dose, live-attenuated vaccine is licensed in the United States and Europe to prevent HZ and it is included in some national immunization programs. The clinical efficacy, safety and tolerability of the vaccine has been demonstrated in two large phase III clinical trials, involving more than 38,000 and 22,000 individuals aged ≥60 and 50-59 years, respectively. This comprehensive review summarizes the extensive "real-world" effectiveness and safety data from both immunocompetent and immunocompromised individuals. These data confirm those from the clinical trials, supporting the use of HZ vaccine in clinical practice and provide evidence that the current recommendations for immunocompromised individuals should be revised. Funding for the editorial assistance, article processing charges, and open access fee for this publication was provided by Sanofi Pasteur MSD.

Reporting Point and Interval Estimates of Effect-Size for Planned Contrasts: Fixed within Effect Analyses of Variance

ERIC Educational Resources Information Center

Robey, Randall R.

2004-01-01

The purpose of this tutorial is threefold: (a) review the state of statistical science regarding effect-sizes, (b) illustrate the importance of effect-sizes for interpreting findings in all forms of research and particularly for results of clinical-outcome research, and (c) demonstrate just how easily a criterion on reporting effect-sizes in…

Current clinical trials testing combinations of immunotherapy and radiation.

PubMed

Crittenden, Marka; Kohrt, Holbrook; Levy, Ronald; Jones, Jennifer; Camphausen, Kevin; Dicker, Adam; Demaria, Sandra; Formenti, Silvia

2015-01-01

Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an abscopal effect. Granulocyte-macrophage colony-stimulating factor was administered during radiotherapy to a metastatic site in patients with metastatic solid tumors to translate evidence obtained in a murine model of syngeneic mammary carcinoma treated with cytokine FLT-3L and radiation. Subsequent clinical availability of vaccines and immune checkpoint inhibitors has triggered a wave of enthusiasm for testing them in combination with radiotherapy. Examples of ongoing clinical trials are described in this report. Importantly, most of these trials include careful immune monitoring of the patients enrolled and will generate important data about the proimmunogenic effects of radiation in combination with a variety of immune modulators, in different disease settings. Results of these studies are building a platform of evidence for radiotherapy as an adjuvant to immunotherapy and encourage the growth of this novel field of radiation oncology. Copyright © 2015 Elsevier Inc. All rights reserved.

A point of minimal important difference (MID): a critique of terminology and methods.

PubMed

King, Madeleine T

2011-04-01

The minimal important difference (MID) is a phrase with instant appeal in a field struggling to interpret health-related quality of life and other patient-reported outcomes. The terminology can be confusing, with several terms differing only slightly in definition (e.g., minimal clinically important difference, clinically important difference, minimally detectable difference, the subjectively significant difference), and others that seem similar despite having quite different meanings (minimally detectable difference versus minimum detectable change). Often, nuances of definition are of little consequence in the way that these quantities are estimated and used. Four methods are commonly employed to estimate MIDs: patient rating of change (global transition items); clinical anchors; standard error of measurement; and effect size. These are described and critiqued in this article. There is no universal MID, despite the appeal of the notion. Indeed, for a particular patient-reported outcome instrument or scale, the MID is not an immutable characteristic, but may vary by population and context. At both the group and individual level, the MID may depend on the clinical context and decision at hand, the baseline from which the patient starts, and whether they are improving or deteriorating. Specific estimates of MIDs should therefore not be overinterpreted. For a given health-related quality-of-life scale, all available MID estimates (and their confidence intervals) should be considered, amalgamated into general guidelines and applied judiciously to any particular clinical or research context.

How Can We Improve Outcomes for Patients and Families Under Palliative Care? Implementing Clinical Audit for Quality Improvement in Resource Limited Settings

PubMed Central

Selman, Lucy; Harding, Richard

2010-01-01

Palliative care in India has made enormous advances in providing better care for patients and families living with progressive disease, and many clinical services are well placed to begin quality improvement initiatives, including clinical audit. Clinical audit is recognized globally to be essential in all healthcare, as a way of monitoring and improving quality of care. However, it is not common in developing country settings, including India. Clinical audit is a cyclical activity involving: identification of areas of care in need of improvement, through data collection and analysis utilizing an appropriate questionnaire; setting measurable quality of care targets in specific areas; designing and implementing service improvement strategies; and then re-evaluating quality of care to assess progress towards meeting the targets. Outcome measurement is an important component of clinical audit that has additional advantages; for example, establishing an evidence base for the effectiveness of services. In resource limited contexts, outcome measurement in clinical audit is particularly important as it enables service development to be evidence-based and ensures resources are allocated effectively. Key success factors in conducting clinical audit are identified (shared ownership, training, managerial support, inclusion of all members of staff and a positive approach). The choice of outcome measurement tool is discussed, including the need for a culturally appropriate and validated measure which is brief and simple enough to incorporate into clinical practice and reflects the holistic nature of palliative care. Support for clinical audit is needed at a national level, and development and validation of an outcome measurement tool in the Indian context is a crucial next step. PMID:20859465

Bridging the boundaries between scientists and clinicians-mechanistic hypotheses and patient stories in risk assessment of drugs.

PubMed

Rocca, Elena

2017-02-01

The cultural divide between scientists and clinicians has been described as undermining the advance of medical science, by hindering the production of practice-relevant research and of research-informed clinical decisions. Here, I consider the field of post-marketing risk assessment of drugs as an example of strict interdependence between basic biomedical research, clinical research, and clinical evaluation and show how it would benefit from a closer collaboration between scientists and clinicians. The risk assessment of drugs after their marketing relies on spontaneous adverse effect reports to drug agencies and on peer-reviewed case reports. I emphasize the importance of qualitative analysis of such reports for the improvement of mechanistic understanding of harmful effects of drugs. I argue that mechanistic explanations of drug effects are at least as important as determination of their frequency, in order to establish causation. An ideal risk assessment, then, verifies not only the frequency of undesired effects but also why and how the harm happens. For this purpose, the frequency or novelty of the unintended outcome, although contextually indicative, should not determine the epistemic value of a report. Details about the context that generated an unexpected outcome, instead, can offer the chance of improving causal understanding about how the intervention works. This is illustrated through examples from medical research. Mechanistic understanding is a domain of joint collaboration among (1) clinicians, in charge of detailed, qualitative reporting of patient stories about side effects, (2) qualitative clinical researchers, in charge of analyzing clinical contexts or harmful effects and formulating explanatory hypotheses, and (3) basic biomedical researchers, in charge of verifying such hypotheses. In addition, direct information flow can on one side focus clinicians' attention on knowledge gaps about drugs/effects where more research is needed, while on the other side create a more contextualized concept of mechanism among scientists. © 2016 John Wiley & Sons, Ltd.

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

PubMed

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

2018-06-01

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

Does the choice of display system influence perception and visibility of clinically relevant features in digital pathology images?

NASA Astrophysics Data System (ADS)

Kimpe, Tom; Rostang, Johan; Avanaki, Ali; Espig, Kathryn; Xthona, Albert; Cocuranu, Ioan; Parwani, Anil V.; Pantanowitz, Liron

2014-03-01

Digital pathology systems typically consist of a slide scanner, processing software, visualization software, and finally a workstation with display for visualization of the digital slide images. This paper studies whether digital pathology images can look different when presenting them on different display systems, and whether these visual differences can result in different perceived contrast of clinically relevant features. By analyzing a set of four digital pathology images of different subspecialties on three different display systems, it was concluded that pathology images look different when visualized on different display systems. The importance of these visual differences is elucidated when they are located in areas of the digital slide that contain clinically relevant features. Based on a calculation of dE2000 differences between background and clinically relevant features, it was clear that perceived contrast of clinically relevant features is influenced by the choice of display system. Furthermore, it seems that the specific calibration target chosen for the display system has an important effect on the perceived contrast of clinically relevant features. Preliminary results suggest that calibrating to DICOM GSDF calibration performed slightly worse than sRGB, while a new experimental calibration target CSDF performed better than both DICOM GSDF and sRGB. This result is promising as it suggests that further research work could lead to better definition of an optimized calibration target for digital pathology images resulting in a positive effect on clinical performance.

Hypnotic Approaches for Chronic Pain Management

PubMed Central

Jensen, Mark P.; Patterson, David R.

2015-01-01

The empirical support for hypnosis for chronic pain management has flourished over the past two decades. Clinical trials show that hypnosis is effective for reducing chronic pain, although outcomes vary between individuals. The findings from these clinical trials also show that hypnotic treatments have a number of positive effects beyond pain control. Neurophysiological studies reveal that hypnotic analgesia has clear effects on brain and spinal-cord functioning that differ as a function of the specific hypnotic suggestions made, providing further evidence for the specific effects of hypnosis. The research results have important implications for how clinicians can help their clients experience maximum benefits from hypnosis and treatments that include hypnotic components. PMID:24547802

The effect of pre- and after-treatment of sevoflurane on central ischemia tolerance and the underlying mechanisms

PubMed Central

2018-01-01

In recent years, with continuous research efforts targeted at studying the effects of pre- and after-treatment of inhaled anesthetics, significant progress has been made regarding the common clinical use of low concentrations of inhaled sevoflurane and its effect on induced central ischemia tolerance by pre- and post-treatment. In this study, we collected, analyzed, classified, and summarized recent literature regarding the effect of sevoflurane on central ischemia tolerance and its related mechanisms. In addition, we provide a theoretical basis for the clinical application of sevoflurane to protect the central nervous system and other important organs against ischemic injury. PMID:29556553

Safety and clinical effectiveness of a compounded sustained-release formulation of buprenorphine for postoperative analgesia in New Zealand White rabbits.

PubMed

DiVincenti, Louis; Meirelles, Luiz A D; Westcott, Robin A

2016-04-01

To determine the clinical effectiveness and safety of a compounded sustained-release formulation of buprenorphine, compared with effects of regular buprenorphine, for postoperative analgesia in rabbits. Blinded randomized controlled clinical trial. 24 purpose-bred adult male New Zealand White rabbits. Rabbits received titanium implants in each tibia as part of another study. Immediately prior to surgery, each rabbit received regular buprenorphine hydrochloride (0.02 mg/kg [0.009 mg/lb], SC, q 12 h for 3 days) or 1 dose of a compounded sustained-release formulation of buprenorphine (0.12 mg/kg [0.055 mg/lb], SC) followed by an equal volume of saline (0.9% NaCl) solution (SC, q 12 h for 3 days) after surgery. For 7 days after surgery, rabbits were evaluated for signs of pain by means of rabbit grimace and activity scoring and for adverse effects. No significant differences were identified between treatment groups in grimace and activity scores at any point. No major adverse effects were detected for either drug. However, 3 rabbits that received regular buprenorphine had pain scores suggestive of moderate to severe pain by the time dose administration was due (ie, within the 12-hour administration interval). No clinically important differences were detected in intraoperative anesthetic or postoperative recovery variables. Sustained-release buprenorphine administered SC at 0.12 mg/kg was at least as effective as regular buprenorphine in providing analgesia for rabbits following orthopedic surgery without any major adverse effects. This sustained-release formulation represents an important alternative for rabbit analgesia with potential to improve rabbit welfare over existing analgesic standards.

Nutraceuticals in cardiovascular prevention: lessons from studies on endothelial function.

PubMed

Zuchi, Cinzia; Ambrosio, Giuseppe; Lüscher, Thomas F; Landmesser, Ulf

2010-08-01

An "unhealthy" diet is considered as a main cause of increased atherosclerotic cardiovascular disease in the industrialized countries. There is a substantial interest in the potential cardiovascular protective effects of "nutraceuticals," that is food-derived substances that exert beneficial health effects. The correct understanding of cardiovascular effects of these compounds will have important implications for cardiovascular prevention strategies. Endothelial dysfunction is thought to play an important role in development and progression of atherosclerosis, and the characterization of the endothelial effects of several nutraceuticals may provide important insights into their potential role in cardiovascular prevention. At the same time, the analysis of the endothelial effects of nutraceuticals may also provide valuable insights into mechanisms of why certain nutraceuticals may not be effective in cardiovascular prevention, and it may aid in the identification of food-derived substances that may have detrimental cardiovascular effects. These findings further support the notion that nutraceuticals do need support from large clinical outcome trials with respect to their efficacy and safety profile for cardiovascular prevention, before their widespread use can be recommended. In fact, the term nutraceutical was coined to encourage an extensive and profound research activity in this field, and numerous large-scale clinical outcome trials to examine the effects of nutraceuticals on cardiovascular events have now been performed or are still ongoing. Whereas it is possible that single nutraceuticals may be effective in cardiovascular prevention, this field of research provides also valuable insights into which food components may be particularly important for cardiovascular prevention, to further advice the composition of a particularly healthy diet. The present review summarizes recent studies on the endothelial effects of several nutraceuticals, that have been intensely studied.

Midodrine Exacerbates Promethazine-induced Akathisia

NASA Technical Reports Server (NTRS)

Platts, Steven H.; Shi, Shang-Jin; Meck, Janice V.

2006-01-01

The study of physiological changes during spaceflight, and the pursuit of remedies to counteract those changes, often requires unique research protocols that lead to unexpected findings; some with important clinical implications. In our research into the development of treatments to counteract the detrimental cardiovascular effects of spaceflight, we have discovered an important drug interaction between promethazine and midodrine.

Academic detailing can play a key role in assessing and implementing comparative effectiveness research findings.

PubMed

Fischer, Michael A; Avorn, Jerry

2012-10-01

Comparative effectiveness research evaluates the relative effectiveness, safety, and value of competing treatment options in clinically realistic settings. Such evaluations can be methodologically complex and difficult to interpret. There will be a growing need for critical evaluation of comparative effectiveness studies to assess the adequacy of their design and to put new information into a broader context. Equally important, this knowledge will have to be communicated to clinicians in a way that will actually change practice. We identify three challenges to effective dissemination of comparative effectiveness research findings: the difficulty of interpreting comparative effectiveness research data, the need for trusted sources of information, and the challenge of turning research results into clinical action. We suggest that academic detailing-direct outreach education that gives clinicians an accurate and unbiased synthesis of the best evidence for practice in a given clinical area-can translate comparative effectiveness research findings into actions that improve health care decision making and patient outcomes.

Outcomes research in cancer clinical trial cooperative groups: the RTOG model.

PubMed

Bruner, D W; Movsas, B; Konski, A; Roach, M; Bondy, M; Scarintino, C; Scott, C; Curran, W

2004-08-01

The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials. This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations. The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.

Deciphering Sources of Variability in Clinical Pathology.

PubMed

Tripathi, Niraj K; Everds, Nancy E; Schultze, A Eric; Irizarry, Armando R; Hall, Robert L; Provencher, Anne; Aulbach, Adam

2017-01-01

The objectives of this session were to explore causes of variability in clinical pathology data due to preanalytical and analytical variables as well as study design and other procedures that occur in toxicity testing studies. The presenters highlighted challenges associated with such variability in differentiating test article-related effects from the effects of experimental procedures and its impact on overall data interpretation. These presentations focused on preanalytical and analytical variables and study design-related factors and their influence on clinical pathology data, and the importance of various factors that influence data interpretation including statistical analysis and reference intervals. Overall, these presentations touched upon potential effect of many variables on clinical pathology parameters, including animal physiology, sample collection process, specimen handling and analysis, study design, and some discussion points on how to manage those variables to ensure accurate interpretation of clinical pathology data in toxicity studies. This article is a brief synopsis of presentations given in a session entitled "Deciphering Sources of Variability in Clinical Pathology-It's Not Just about the Numbers" that occurred at the 35th Annual Symposium of the Society of Toxicologic Pathology in San Diego, California.

Evidence-based health care: its place within clinical governance.

PubMed

McSherry, R; Haddock, J

This article explores the principles of evidence-based practice and its role in achieving quality improvements within the clinical governance framework advocated by the recent White Papers 'The New NHS: Modern, Dependable' (Department of Health (DoH), 1997) and 'A First Class Service: Quality in the New NHS' (DoH, 1998a). Within these White Papers there is an emphasis on improving quality of care, treatment and services through employing the principles of clinical governance. A major feature of clinical governance is guaranteeing quality to the public and the NHS, and ensuring that clinical, managerial and educational practice is based on scientific evidence. This article also examines what evidence-based practice is and what processes are required to promote effective healthcare interventions. The authors also look at how clinical governance relates to other methods/systems involved in clinical effectiveness. Finally, the importance for nurses and other healthcare professionals of familiarizing themselves with the development of critical appraisal skills, and their implications for developing evidence-based practice, is emphasized.

Effectiveness of clinical pathways for total knee and total hip arthroplasty: literature review.

PubMed

Kim, Stephen; Losina, Elena; Solomon, Daniel H; Wright, John; Katz, Jeffrey N

2003-01-01

Although many hospitals have implemented clinical pathways to standardize the process of care, the effectiveness of clinical pathways for total hip and knee arthroplasties has not been reviewed critically. We searched for articles comparing outcomes of total hip or knee arthroplasty for patients who were treated using clinical pathways as opposed to patients treated without these pathways. Eleven studies met criteria for inclusion. Ten used historical controls, and 1 was a randomized trial. The studies had important methodological limitations. In general, the articles showed that patients treated using pathways experienced shorter hospital stays and lower costs, with comparable clinical outcomes as compared with patients treated without clinical pathways. We concluded that clinical pathways appear successful in reducing costs and length of stay in the acute care hospital, with no compromise in patient outcomes. However, interpretation of these studies is complicated by substantial methodological limitations, particularly the use of historical controls and failure to account for length of stay in rehabilitation facilities. Copyright 2003, Elsevier Science (USA). All rights reserved.

Cost-effectiveness analysis of unsafe abortion and alternative first-trimester pregnancy termination strategies in Nigeria and Ghana.

PubMed

Hu, Delphine; Grossman, Daniel; Levin, Carol; Blanchard, Kelly; Adanu, Richard; Goldie, Sue J

2010-06-01

To explore the policy implications of increasing access to safe abortion in Nigeria and Ghana, we developed a computer-based decision analytic model which simulates induced abortion and its potential complications in a cohort of women, and comparatively assessed the cost-effectiveness of unsafe abortion and three first-trimester abortion modalities: hospital-based dilatation and curettage, hospital- and clinic-based manual vacuum aspiration (MVA), and medical abortion using misoprostol (MA). Assuming all modalities are equally available, clinic-based MVA is the most cost-effective option in Nigeria. If clinic-based MVA is not available, MA is the next best strategy. Conversely, in Ghana, MA is the most cost-effective strategy, followed by clinic-based MVA if MA is not available. From a real world policy perspective, increasing access to safe abortion in favor over unsafe abortion is the single most important factor in saving lives and societal costs, and is more influential than the actual choice of safe abortion modality.

Student's perceptions of effective clinical teaching revisited.

PubMed

Kelly, Claudette

2007-11-01

Despite a wealth of research on clinical teaching, the criteria for determining what constitutes effective clinical teaching remain poorly defined [Cholowski, K., 2002. Nursing students' and clinical educators' perceptions of characteristics of effective clinical educators in an Australian university school of nursing. Journal of Advanced Nursing 39 (5), 412-420]. This paper reports on two studies exploring second and third year nursing student's perceptions of effective clinical teaching over 14 years (1989-2003). The aim of the inquiry was to compare student's perceptions in diploma and baccalaureate programs within existing clinical contexts. This research used a generative approach to elicit learner's views of what teacher characteristics and contextual influences impact them in clinical settings. A convenience sample of 30 students at the end of second and third years volunteered to be interviewed in-depth for each study. The first study was conducted in a diploma program, whereas in the second study all but a few students were elected to complete a four year baccalaureate nursing degree. Findings from both studies are remarkably consistent. Students in both studies rated teacher knowledge as most important followed by feedback and communication skills. Teacher knowledge appeared critical in four areas: as it pertains to the clinical setting, the curriculum, the learner and teaching/learning theory. How well students perceived that they were accepted by staff, student-teacher ratios and peer support also appeared to impact student's views of effective clinical teaching. This research has implications for employment and evaluation practices for teachers in applied fields such as nursing. The study raises questions about the recent trend toward temporary employment of clinical teachers and in the separation of academic and clinical roles of nurse educators.

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.

PubMed

Koren, Eugen; Smith, Holly W; Shores, Elizabeth; Shankar, Gopi; Finco-Kent, Deborah; Rup, Bonita; Barrett, Yu-Chen; Devanarayan, Viswanath; Gorovits, Boris; Gupta, Shalini; Parish, Thomas; Quarmby, Valerie; Moxness, Michael; Swanson, Steven J; Taniguchi, Gary; Zuckerman, Linda A; Stebbins, Christopher C; Mire-Sluis, Anthony

2008-04-20

The appropriate evaluation of the immunogenicity of biopharmaceuticals is of major importance for their successful development and licensure. Antibodies elicited by these products in many cases cause no detectable clinical effects in humans. However, antibodies to some therapeutic proteins have been shown to cause a variety of clinical consequences ranging from relatively mild to serious adverse events. In addition, antibodies can affect drug efficacy. In non-clinical studies, anti-drug antibodies (ADA) can complicate interpretation of the toxicity, pharmacokinetic (PK) and pharmacodynamic (PD) data. Therefore, it is important to develop testing strategies that provide valid assessments of antibody responses in both non-clinical and clinical studies. This document provides recommendations for antibody testing strategies stemming from the experience of contributing authors. The recommendations are intended to foster a more unified approach to antibody testing across the biopharmaceutical industry. The strategies proposed are also expected to contribute to better understanding of antibody responses and to further advance immunogenicity evaluation.

Exploring cognitive integration of basic science and its effect on diagnostic reasoning in novices.

PubMed

Lisk, Kristina; Agur, Anne M R; Woods, Nicole N

2016-06-01

Integration of basic and clinical science knowledge is increasingly being recognized as important for practice in the health professions. The concept of 'cognitive integration' places emphasis on the value of basic science in providing critical connections to clinical signs and symptoms while accounting for the fact that clinicians may not spontaneously articulate their use of basic science knowledge in clinical reasoning. In this study we used a diagnostic justification test to explore the impact of integrated basic science instruction on novices' diagnostic reasoning process. Participants were allocated to an integrated basic science or clinical science training group. The integrated basic science group was taught the clinical features along with the underlying causal mechanisms of four musculoskeletal pathologies while the clinical science group was taught only the clinical features. Participants completed a diagnostic accuracy test immediately after initial learning, and one week later a diagnostic accuracy and justification test. The results showed that novices who learned the integrated causal mechanisms had superior diagnostic accuracy and better understanding of the relative importance of key clinical features. These findings further our understanding of cognitive integration by providing evidence of the specific changes in clinical reasoning when basic and clinical sciences are integrated during learning.

Grace under fire: aesthetic leadership in clinical nursing.

PubMed

Mannix, Judy; Wilkes, Lesley; Daly, John

2015-09-01

This paper reports the results of an online descriptive survey that sought to determine nurses' perceptions of aesthetic leadership among clinical leaders in nursing. Clinical leadership has been identified as an essential component to ensuring the delivery of safe, high-quality health care. Leadership has been increasingly linked in the literature to aesthetics. However, little consideration has been given to aesthetics in relation to clinical leadership in nursing. A mixed-method, online descriptive survey. Participants were recruited via e-learning platforms and social media. A total of 66 surveys were completed, including 31 written accounts of aesthetic leadership in practice. Aesthetic leadership characteristics in clinical leaders most valued are support, communication and the approach taken to colleagues. Taking risks and challenging processes were least likely to be evident among effective clinical leaders. Aesthetic leadership is multi-dimensional and a style of leadership to positively influence the clinical workplace. Support, effective communication and taking into consideration the feelings of colleagues are important dimensions of aesthetic leadership. Aesthetic leadership represents a way for clinical leaders to create and sustain a calm and positive clinical workplace. © 2015 John Wiley & Sons Ltd.

Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics.

PubMed

Simon, Richard

2008-06-01

Developments in genomics and biotechnology provide unprecedented opportunities for the development of effective therapeutics and companion diagnostics for matching the right drug to the right patient. Effective co-development involves many new challenges with increased opportunity for success as well as delay and failure. Clinical trial designs and adaptive analysis plans for the prospective design of pivotal trials of new therapeutics and companion diagnostics are reviewed. Effective co-development requires careful prospective planning of the design and analysis strategy for pivotal clinical trials. Randomized clinical trials continue to be important for evaluating the effectiveness of new treatments, but the target populations for analysis should be prospectively specified based on the companion diagnostic. Post hoc analyses of traditionally designed randomized clinical trials are often deeply problematic. Clear separation is generally required of the data used for developing the diagnostic test, including their threshold of positivity, from the data used for evaluating treatment effectiveness in subsets determined by the test. Adaptive analysis can be used to provide flexibility to the analysis but the use of such methods requires careful planning and prospective definition in order to assure that the pivotal trial adequately limits the chance of erroneous conclusions.

Pressure ulcer prevention in frail older people.

PubMed

Barry, Maree; Nugent, Linda

2015-12-16

Pressure ulcers are painful and cause discomfort, have a negative effect on quality of life, and are costly to treat. The incidence and severity of preventable pressure ulcers is an important indicator of quality of care; it is essential that healthcare providers monitor prevalence and incidence rates to ensure that care strategies implemented are effective. Frail older people are at increased risk of developing pressure ulcers. This article discusses the complexities of preventing pressure ulcers in frail older people and emphasises the importance of structured educational programmes that incorporate effective clinical leadership and multidisciplinary teamwork.

Investigating the Use of Mastery-Style Online Homework Exercises in Introductory Algebra-Based Mechanics in a Controlled Clinical Study

ERIC Educational Resources Information Center

Evans, William R.; Selen, Mats A.

2017-01-01

Homework in introductory physics represents an important part of a student's learning experience; therefore, choosing the manner in which homework is presented merits investigation. We performed three rounds of clinical trials comparing the effects of mastery-style homework vs. traditional-style homework with students in both algebra-based and…

Clinical leadership in health care: a position statement.

PubMed

Millward, Lynne J; Bryan, Karen

2005-01-01

This paper aims to briefly review leadership within the contemporary UK National Health Services (NHS) including Department of Health and Royal College of Nursing (RCN) initiatives. It is argued that the concept of clinical leadership is a viable and important one, and is theoretically consistent with the contemporary social psychological literature on the importance of "local" leadership to effective organizational functioning. Field theory proposes that local influences (e.g. local management) on attitudes and behaviour will to a large extent mediate the impact of the organization (e.g. organisational structure and values) on (in this instance) health care delivery. The reality of clinical leadership must involve a judicious blend effective management in the conventional sense with skill in transformational change in order to make real difference to the care delivery process. For leadership initiatives to become truly culturally embedded into the "way we do things around here", they require more than just individual training and development. A view is offered for the practical interpretation of the clinical leadership concept in relationship terms. This will involve management of the relationship between health care professionals, between health care professionals and the "organizations" to which they are accountable and between health care professionals and service users.

Beta-Blockers and Nitrates: Pharmacotherapy and Indications.

PubMed

Facchini, Emanuela; Degiovanni, Anna; Cavallino, Chiara; Lupi, Alessandro; Rognoni, Andrea; Bongo, Angelo S

2015-01-01

Many clinically important differences exist between beta blockers. B1-selectivity is of clinical interest because at clinically used doses, b1- selective agents block cardiac b-receptors while having minor effects on bronchial and vascular b-receptors. Beta-adrenergic blocking agents significantly decrease the frequency and duration of angina pectoris, instead the prognostic benefit of beta-blockers in stable angina has been extrapolated from studies of post myocardial infarction but has not yet been documented without left ventricular disfunction or previous myocardial infarction. Organic nitrates are among the oldest drugs, but they still remain a widely used adjuvant in the treatment of symptomatic coronary artery disease. While their efficacy in relieving angina pectoris symptoms in acute settings and in preventing angina before physical or emotional stress is undisputed, the chronic use of nitrates has been associated with potentially important side effects such as tolerance and endothelial dysfunction. B-blockers are the firstline anti-anginal therapy in stable stable angina patients without contraindications, while nitrates are the secondline anti-anginal therapy. Despite 150 years of clinical practice, they remain fascinating drugs, which in a chronic setting still deserve investigation. This review evaluated pharmacotherapy and indications of Beta-blockers and nitrates in stable angina.

Athletic Training Clinical Instructors as Situational Leaders.

PubMed

Meyer, Linda Platt

2002-12-01

OBJECTIVE: To present Situational Leadership as a model that can be implemented by clinical instructors during clinical education. Effective leadership occurs when the leadership style is matched with the observed followers' characteristics. Effective leaders anticipate and assess change and adapt quickly and grow with the change, all while leading followers to do the same. As athletic training students' levels of readiness change, clinical instructors also need to transform their leadership styles and strategies to match the students' ever-changing observed needs in different situations. DATA SOURCES: CINAHL (1982-2002), MEDLINE (1990-2001), SPORT Discus (1949-2002), ERIC (1966-2002), and Internet Web sites were searched. Search terms included leadership, situational leadership, clinical instructors and leadership, teachers as leaders, and clinical education. DATA SYNTHESIS: Situational Leadership is presented as a leadership model to be used by clinical instructors while teaching and supervising athletic training students in the clinical setting. This model can be implemented to improve the clinical-education process. Situational leaders, eg, clinical instructors, must have the flexibility and range of skills to vary their leadership styles to match the challenges that occur while teaching athletic training students. CONCLUSIONS/RECOMMENDATIONS: This leadership style causes the leader to carry a substantial responsibility to lead while giving power away. Communication is one of the most important leadership skills to develop to become an effective leader. It is imperative for the future of the profession that certified athletic trainers continue to develop effective leadership skills to address the changing times in education and expectations of the athletic training profession.

Pharmacological interventions to improve cognition and adaptive functioning in Down syndrome: Strides to date.

PubMed

Hart, Sarah J; Visootsak, Jeannie; Tamburri, Paul; Phuong, Patrick; Baumer, Nicole; Hernandez, Maria-Clemencia; Skotko, Brian G; Ochoa-Lubinoff, Cesar; Liogier D'Ardhuy, Xavier; Kishnani, Priya S; Spiridigliozzi, Gail A

2017-11-01

Although an increasing number of clinical trials have been developed for cognition in Down syndrome, there has been limited success to date in identifying effective interventions. This review describes the progression from pre-clinical studies with mouse models to human clinical trials research using pharmacological interventions to improve cognition and adaptive functioning in Down syndrome. We also provide considerations for investigators when conducting human clinical trials and describe strategies for the pharmaceutical industry to advance the field in drug discovery for Down syndrome. Future research focusing on earlier pharmaceutical interventions, development of appropriate outcome measures, and greater collaboration between industry, academia, advocacy, and regulatory groups will be important for addressing limitations from prior studies and developing potential effective interventions for cognition in Down syndrome. © 2017 Wiley Periodicals, Inc.

Linking the Tinnitus Questionnaire and the subjective Clinical Global Impression: Which differences are clinically important?

PubMed Central

2012-01-01

Background Development of new tinnitus treatments requires prospective placebo-controlled randomized trials to prove their efficacy. The Tinnitus Questionnaire (TQ) is a validated and commonly used instrument for assessment of tinnitus severity and has been used in many clinical studies. Defining the Minimal Clinically Important Difference (MCID) for TQ changes is an important step to a better interpretation of the clinical relevance of changes observed in clinical trials. In this study we aimed to estimate the minimum change of the TQ score that could be considered clinically relevant. Methods 757 patients with chronic tinnitus were pooled from the TRI database and the RESET study. An anchor-based approach using the Clinical Global Impression (CGI) scale and distributional approaches were used to estimate MCID. Receiver Operating Characteristic (ROC) curves were calculated to define optimal TQ change cutoffs discriminating between minimally changed and unchanged subjects. Results The relationship between TQ change scores and CGI ratings of change was good (r = 0.52, p < 0.05). Mean change scores associated with minimally better and minimally worse CGI categories were −6.65 and +2.72 respectively. According to the ROC method MCID for improvement was −5 points and for deterioration +1 points. Conclusion Distribution and anchor-based methods yielded comparable results in identifying MCIDs. ΔTQ scores of −5 and +1 points were identified as the minimal clinically relevant change for improvement and worsening respectively. The asymmetry of the MCIDs for improvement and worsening may be related to expectation effects. PMID:22781703

Undergraduate nursing students' experience related to their clinical learning environment and factors affecting to their clinical learning process.

PubMed

Arkan, Burcu; Ordin, Yaprak; Yılmaz, Dilek

2018-03-01

Clinical education is an essential part of nursing education. The purpose of this study was to explore nurse students' experiences related to cinical learning environments, factors effecting to clinical learning process. Descriptive qualitative design was used in this study, and data were collected from 2nd class nursing student (n = 14). The study took the form of in-depth interviews between August-October 2015. The qualitative interviews were analyzed by using simple content analysis. Data were analyzed manually. Experiences nurse students are described five themes. The themes of the study are (1) effecting persons to clinical learning, (2) educational atmosphere, (3) students' personal charactering, (4) the impact of education in school, and (5) students' perceptions related to clinical learning. Participants stated that they experienced many difficulties during clinical learning process. All students importantly stated that nurse teacher is very effecting to clinical learning. This study contributes to the literature by providing data on beginner nursing student' experiences about clinical learning process. The data of this present study show to Turkish nursing student is affecting mostly from persons in clinical learning. The data of this present study will guide nurse teacher when they plan to interventions to be performed to support student during clinical learning process. Copyright © 2017 Elsevier Ltd. All rights reserved.

Clinical leadership in mental health nursing: the importance of a calm and confident approach.

PubMed

Ennis, Gary; Happell, Brenda; Reid-Searl, Kerry

2015-01-01

Explore the perceptions of nurses working in mental health of effective clinical leadership. In-depth interviews were conducted with registered nurses employed in a mental health setting. Qualitative research using grounded theory. Remaining calm and confident in times of crisis and uncertainty was identified as one attribute of clinical leadership. Participants noted clinical leaders' demeanor during stressful or crisis situations, and their ability to manage unpredictable or unexpected clinical situations as contributing positively to clinical practice. Understanding these characteristics and how they can influence positive outcomes for clients is crucial in addressing the recruitment and retention challenges for the nursing workforce. © 2014 Wiley Periodicals, Inc.

Can we "predict" long-term outcome for ambulatory transcutaneous electrical nerve stimulation in patients with chronic pain?

PubMed

Köke, Albère J; Smeets, Rob J E M; Perez, Roberto S; Kessels, Alphons; Winkens, Bjorn; van Kleef, Maarten; Patijn, Jacob

2015-03-01

Evidence for effectiveness of transcutaneous electrical nerve stimulation (TENS) is still inconclusive. As heterogeneity of chronic pain patients might be an important factor for this lack of efficacy, identifying factors for a successful long-term outcome is of great importance. A prospective study was performed to identify variables with potential predictive value for 2 outcome measures on long term (6 months); (1) continuation of TENS, and (2) a minimally clinical important pain reduction of ≥ 33%. At baseline, a set of risk factors including pain-related variables, psychological factors, and disability was measured. In a multiple logistic regression analysis, higher patient's expectations, neuropathic pain, no severe pain (< 80 mm visual analogue scale [VAS]) were independently related to long-term continuation of TENS. For the outcome "minimally clinical important pain reduction," the multiple logistic regression analysis indicated that no multisited pain (> 2 pain locations) and intermittent pain were positively and independently associated with a minimally clinical important pain reduction of ≥ 33%. The results showed that factors associated with a successful outcome in the long term are dependent on definition of successful outcome. © 2014 World Institute of Pain.

A Study on Fitts' Law Based Gait Symmetric Evaluation and It's Clinic Application.

PubMed

Rencheng, Wang; Meiqin, Zhang; Xiaonan, Deng; Dewen, Jin; Maobin, Wang; Guangqing, Li

2005-01-01

Symmetry, one of the prominent characters of normal human gait, could be destroyed by some special or abnormal factors such as barrier spanning, walking impediment, etc. Therefore, it becomes an important factor used to evaluate qualities and functions of walking. In this paper, the fitts' law based symmetry index calculation is introduced and its application in clinic test is also reported. The results show that the fitts' law based index is effective in clinic evaluation.

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

Understanding the Role of P Values and Hypothesis Tests in Clinical Research.

PubMed

Mark, Daniel B; Lee, Kerry L; Harrell, Frank E

2016-12-01

P values and hypothesis testing methods are frequently misused in clinical research. Much of this misuse appears to be owing to the widespread, mistaken belief that they provide simple, reliable, and objective triage tools for separating the true and important from the untrue or unimportant. The primary focus in interpreting therapeutic clinical research data should be on the treatment ("oomph") effect, a metaphorical force that moves patients given an effective treatment to a different clinical state relative to their control counterparts. This effect is assessed using 2 complementary types of statistical measures calculated from the data, namely, effect magnitude or size and precision of the effect size. In a randomized trial, effect size is often summarized using constructs, such as odds ratios, hazard ratios, relative risks, or adverse event rate differences. How large a treatment effect has to be to be consequential is a matter for clinical judgment. The precision of the effect size (conceptually related to the amount of spread in the data) is usually addressed with confidence intervals. P values (significance tests) were first proposed as an informal heuristic to help assess how "unexpected" the observed effect size was if the true state of nature was no effect or no difference. Hypothesis testing was a modification of the significance test approach that envisioned controlling the false-positive rate of study results over many (hypothetical) repetitions of the experiment of interest. Both can be helpful but, by themselves, provide only a tunnel vision perspective on study results that ignores the clinical effects the study was conducted to measure.

Effect of Listeners' Linguistic Background on Perceptual Judgements of Hypernasality

ERIC Educational Resources Information Center

Lee, Alice; Brown, Susanna; Gibbon, Fiona E.

2008-01-01

Background: Many speech and language therapists work in a multilingual environment, making cross-linguistic studies of speech disorders clinically and theoretically important. Aims: To investigate the effect of listeners' linguistic background on their perceptual ratings of hypernasality and the reliability of the ratings. Methods &…

Early Learner Perceptions of the Attributes of Effective Preceptors

ERIC Educational Resources Information Center

Huggett, Kathryn N.; Warrier, Rugmini; Maio, Anna

2008-01-01

Medical education in the US has adapted to the shift of patient care from hospital to ambulatory settings by developing educational opportunities in outpatient settings. Faculty development efforts must acknowledge learners' perspectives to be effective in improving teaching and learning. Clinics provide important and unique learning…

Review of patient-reported outcome measures in chronic hepatitis C

PubMed Central

2012-01-01

Background Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design. Methods A three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest. Results This multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations. Conclusions This review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to ensure that CHC clinical trials evaluate concepts that are important to patients and include measures that have evidence supporting content validity, reliability, construct validity, and responsiveness. PMID:22871087

Cost, Coverage, and Comparative Effectiveness Research: The Critical Issues for Oncology

PubMed Central

Pearson, Steven D.

2012-01-01

A new national initiative in comparative effectiveness research (CER) is part of a broad and long-term evolution toward greater reliance on scientific evidence in clinical practice and medical policy. But CER has been controversial because of its high profile in the health care reform effort, its instantiation in a prominent new national research institute, and lingering concerns that the ultimate goal of CER is to empower the government and private insurers to reduce health care costs by restricting access to expensive new medical tests and treatments. This article presents an analysis of the policy development behind CER and focuses on its potential impact on insurance coverage and payment for oncology services. By itself, CER will not solve the tension that exists between the goal of innovative, personalized care and the eroding affordability of cancer treatment in the United States. But CER does offer an important opportunity for progress. Oncologists have taken important first steps in acknowledging their responsibility for addressing cost issues; as a professional society, they should now move forward to assume leadership in the effort to integrate clinical evidence with considerations of cost effectiveness to guide clinical practice and insurer policies. PMID:23071229

EXTRAHEPATIC TOXICITY OF ACETAMINOPHEN: CRITICAL EVALUATION OF THE EVIDENCE AND PROPOSED MECHANISMS

PubMed Central

Kennon-McGill, Stefanie; McGill, Mitchell R.

2017-01-01

Research on acetaminophen (APAP) toxicity over the last several decades has focused on the pathophysiology of liver injury, but increasing attention is being paid to other known and possible adverse effects. It has been known for decades that APAP causes acute kidney injury, but confusion exists regarding prevalence, and the mechanisms have not been well investigated. More recently, a number of experimental, clinical and epidemiological studies have reported evidence for pulmonary, endocrine, neurological and neurodevelopmental toxicity, but the quality of evidence from those studies varies. It is important to consider these data due to implications for regulation and clinical practice. Here, we review the evidence and proposed mechanisms for extrahepatic adverse effects of APAP and weigh weaknesses and strengths in the data. We consider results from clinical, epidemiological and experimental research. Our goal is to determine the strength of claims regarding extrahepatic toxicity of APAP and to identify areas of need for future research. It is especially important to view claims of developmental effects of antenatal APAP exposure with a critical eye because APAP is currently the only over-the-counter medication recommended for pregnant women to self-treat pain and fever. PMID:29457141

Exploring the link between clinical managers involvement in budgeting and performance: Insights from the Italian public health care sector.

PubMed

Macinati, Manuela S; Rizzo, Marco G

2016-01-01

The public health care sector has had an increase in initiatives, mostly inspired by New Public Management principles, aimed at assigning financial accountability to clinical managers. However, clinical managers might experience a scarce alignment between professional values and organizational requirements, which is a potentially important phenomena that may result in negative consequences on clinical managers' job performance. Building on Psychological Ownership Theory and adopting a psychology-based management accounting research approach, we focus on the managerial (nonmedical) role the clinical manager fulfills and explore the budgetary participation-performance link via the indirect effects of job-based psychological ownership, role clarity, and clinical managers' affective commitment toward managerial roles. The data were collected by a survey conducted in an Italian hospital. The research hypotheses were tested employing a path model. Our study revealed new insights that shed some light on underexplored processes through which mental states mediate the participation-performance link. Among these latter, the findings demonstrate that (a) budgetary participation has a direct effect on job-based psychological ownership; (b) role clarity mediates participation- and job-based psychological ownership link; (c) role clarity and job-based psychological ownership partially mediate the participation-commitment link; and (d) job-based psychological ownership, role clarity, and commitment fully mediate the participation-performance link. From a managerial viewpoint, an understanding of how clinical managers' feelings of ownership toward managerial roles could be enhanced is imperative in health care because ownership accounts for important attitudinal and organizational consequences. Results suggest that health care organizations that invest in budgetary participation will directly and indirectly affect clinical managers' psychological ownership, and this, along with role clarity, motivates clinical managers' managerial work attitudes and performance.

Functional decline after incident wrist fractures—Study of Osteoporotic Fractures: prospective cohort study

PubMed Central

Song, Jing; Dunlop, Dorothy D; Fink, Howard A; Cauley, Jane A

2010-01-01

Objective To study the effect of an incident wrist fracture on functional status in women enrolled in the Study of Osteoporotic Fractures. Design Prospective cohort study. Setting Baltimore, Minneapolis, Portland, and the Monongahela valley in Pennsylvania, USA Participants 6107 women aged 65 years and older without previous wrist or hip fracture recruited from the community between September 1986 and October 1988. Main outcome measure Clinically important functional decline, defined as a functional deterioration of 5 points in five activities of daily living each scored from 0 to 3 (equivalent to one standard deviation decrease in functional ability). Results Over a mean follow-up of 7.6 years, 268 women had an incident wrist fracture and 41 (15%) of these developed clinically important functional decline. Compared with women without wrist fractures, those with incident wrist fractures had greater annual functional decline after adjustment for age, body mass index, and health status. Occurrence of a wrist fracture increased the odds of having a clinically important functional decline by 48% (odds ratio 1.48, 95% confidence interval 1.04 to 2.12), even after adjustment for age, body mass index, health status, baseline functional status, lifestyle factors, comorbidities, and neuromuscular function. Conclusions Wrist fractures contribute to clinically important functional decline in older women. PMID:20616099

Antiepileptic treatment in paediatric oncology--an interdisciplinary challenge.

PubMed

Tibussek, D; Distelmaier, F; Schönberger, S; Göbel, U; Mayatepek, E

2006-01-01

Epileptic seizures are a common and clinically relevant problem in paediatric oncology. Attributable to the heterogeneity of this group of patients and a number of possible comorbidities antiepileptic treatment in paediatric oncology poses a number of diagnostic and therapeutic challenges. This requires a close interdisciplinary approach to the seizing child or adolescent. A prompt and detailed diagnostic work-up is needed in every case in order to establish the diagnosis and, equally important, to detect secondary aetiological factors, e. g. epileptogenic drugs or any acute underlying pathology, such as metabolic or toxic encephalopathies, CNS-infections or cerebrovascular events. This might offer the opportunity for a specific causative treatment and thus prevent unnecessary long-term antiepileptic drug (AED) treatment. If AED treatment is initiated several aspects have to be taken into account. Most importantly, AEDs and chemotherapeutic drugs (CTDs) may interact. Depending on the comedication this may result in reduced tumour or seizure control or unexpected toxicity of AEDs or CTDs. Understanding these interactions will allow to anticipate clinically relevant adverse effects. AED may be further complicated by side-effects, some of them of particular concern for children or adolescents, such as cognitive effects, myelotoxicity, serious rashes, endocrinological disturbances, and many more. Beside critically questioning the need for AED treatment it is therefore important to prefer AED with a good safety-profile in this population. Enzyme-inducing and inhibiting AED should be avoided if possible. Preliminary studies indicate that gabapentin and levetiracetam may provide good options in terms of efficacy and safety. However, more properly designed clinical studies are warranted to raise the level of evidence for robust clinical recommendations. Until that time, clinicians will need to continue to question current policies and adapt their daily practice to evolving scientific data.

Treating sarcopenia in clinical practice: where are we now?

PubMed

De Spiegeleer, Anton; Petrovic, Mirko; Boeckxstaens, Pauline; Van Den Noortgate, Nele

2016-08-01

Sarcopenia - or the loss of muscle mass, strength and function with ageing - represents an important health issue of the twenty-first century because of its devastating effects in addition to an increased prevalence of aged people. The devastating health effects of sarcopenia are multiple: an increased falls risk, a decreased physical ability and quality of life and an independent increase of all-cause mortality. Although the ultimate remedy for sarcopenia yet has to be found, some interventions have proven their merit and might be of practical use in clinical practice, especially for geriatricians, who deal most with sarcopenia. This review intends to summarize the current therapeutic interventions, their proposed mechanism of action as well as their clinical value. The results of our review highlight the importance of exercise (50% resistance training, 50% endurance training), nutrition (25-30 g proteins with essential amino acids every meal and long-chain ω-3 fatty acids) and limitation of alcohol and smoking. In addition, studies also suggest a place for vitamin D (aim serum levels >30 ng/L), testosterone (aim serum levels >300 ng/dL) and creatine (15-20 g/d for five days, thereafter 3-5 g/d). In conclusion, although more studies are needed to elucidate the exact effectiveness and safety of many sarcopenia interventions, the current evidence already provides clinically useful information, which might benefit the patient with (pre-)sarcopenia.

Liposomal Bupivacaine Does Not Reduce Inpatient Opioid Prescription or Related Complications after Knee Arthroplasty: A Database Analysis.

PubMed

Pichler, Lukas; Poeran, Jashvant; Zubizarreta, Nicole; Cozowicz, Crispiana; Sun, Eric C; Mazumdar, Madhu; Memtsoudis, Stavros G

2018-05-21

Although some trials suggest benefits of liposomal bupivacaine, data on real-world use and effectiveness is lacking. This study analyzed the impact of liposomal bupivacaine use (regardless of administration route) on inpatient opioid prescription, resource utilization, and opioid-related complications among patients undergoing total knee arthroplasties with a peripheral nerve block. It was hypothesized that liposomal bupivacaine has limited clinical influence on the studied outcomes. The study included data on 88,830 total knee arthroplasties performed with a peripheral nerve block (Premier Healthcare Database 2013 to 2016). Multilevel multivariable regressions measured associations between use of liposomal bupivacaine and (1) inpatient opioid prescription (extracted from billing) and (2) length of stay, cost of hospitalization, as well as opioid-related complications. To reflect the difference between statistical and clinical significance, a relative change of -15% in outcomes was assumed to be clinically important. Overall, liposomal bupivacaine was used in 21.2% (n = 18,817) of patients that underwent a total knee arthroplasty with a peripheral nerve block. Liposomal bupivacaine use was not associated with a clinically meaningful reduction in inpatient opioid prescription (group median, 253 mg of oral morphine equivalents, adjusted effect -9.3% CI -11.1%, -7.5%; P < 0.0001) and length of stay (group median, 3 days, adjusted effect -8.8% CI -10.1%, -7.5%; P < 0.0001) with no effect on cost of hospitalization. Most importantly, liposomal bupivacaine use was not associated with decreased odds for opioid-related complications. Liposomal bupivacaine was not associated with a clinically relevant improvement in inpatient opioid prescription, resource utilization, or opioid-related complications in patients who received modern pain management including a peripheral nerve block.

The clinical importance of the metabolite equol-a clue to the effectiveness of soy and its isoflavones.

PubMed

Setchell, Kenneth D R; Brown, Nadine M; Lydeking-Olsen, Eva

2002-12-01

Equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman] is a nonsteroidal estrogen of the isoflavone class. It is exclusively a product of intestinal bacterial metabolism of dietary isoflavones and it possesses estrogenic activity, having affinity for both estrogen receptors, ERalpha and ERbeta. Equol is superior to all other isoflavones in its antioxidant activity. It is the end product of the biotransformation of the phytoestrogen daidzein, one of the two main isoflavones found in abundance in soybeans and most soy foods. Once formed, it is relatively stable; however, equol is not produced in all healthy adults in response to dietary challenge with soy or daidzein. Several recent dietary intervention studies examining the health effects of soy isoflavones allude to the potential importance of equol by establishing that maximal clinical responses to soy protein diets are observed in people who are good "equol-producers." It is now apparent that there are two distinct subpopulations of people and that "bacterio-typing" individuals for their ability to make equol may hold the clue to the effectiveness of soy protein diets in the treatment or prevention of hormone-dependent conditions. In reviewing the history of equol, its biological properties, factors influencing its formation and clinical data, we propose a new paradigm. The clinical effectiveness of soy protein in cardiovascular, bone and menopausal health may be a function of the ability to biotransform soy isoflavones to the more potent estrogenic isoflavone, equol. The failure to distinguish those subjects who are "equol-producers" from "nonequol producers" in previous clinical studies could plausibly explain the variance in reported data on the health benefits of soy.

Meta-analysis in clinical trials revisited.

PubMed

DerSimonian, Rebecca; Laird, Nan

2015-11-01

In this paper, we revisit a 1986 article we published in this Journal, Meta-Analysis in Clinical Trials, where we introduced a random-effects model to summarize the evidence about treatment efficacy from a number of related clinical trials. Because of its simplicity and ease of implementation, our approach has been widely used (with more than 12,000 citations to date) and the "DerSimonian and Laird method" is now often referred to as the 'standard approach' or a 'popular' method for meta-analysis in medical and clinical research. The method is especially useful for providing an overall effect estimate and for characterizing the heterogeneity of effects across a series of studies. Here, we review the background that led to the original 1986 article, briefly describe the random-effects approach for meta-analysis, explore its use in various settings and trends over time and recommend a refinement to the method using a robust variance estimator for testing overall effect. We conclude with a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases. Published by Elsevier Inc.

Meta-Analysis in Clinical Trials Revisited

PubMed Central

Laird, Nan

2015-01-01

In this paper, we revisit a 1986 article we published in this Journal, Meta-Analysis in Clinical Trials, where we introduced a random-effect model to summarize the evidence about treatment efficacy from a number of related clinical trials. Because of its simplicity and ease of implementation, our approach has been widely used (with more than 12,000 citations to date) and the “DerSimonian and Laird method” is now often referred to as the ‘standard approach’ or a ‘popular’ method for meta-analysis in medical and clinical research. The method is especially useful for providing an overall effect estimate and for characterizing the heterogeneity of effects across a series of studies. Here, we review the background that led to the original 1986 article, briefly describe the random-effects approach for meta-analysis, explore its use in various settings and trends over time and recommend a refinement to the method using a robust variance estimator for testing overall effect. We conclude with a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases. PMID:26343745

Antiepileptic drug therapy: clinical laboratory significance.

PubMed

Naradzay, J F; Olshaker, J S

1996-01-01

When evaluating a patient who is taking an antiepileptic medication, it is important for the emergency physician to correlate the clinical presentation with the antiepileptic drug level. Therapeutic ranges have been suggested for most antiepileptic medications, but these must be interpreted in light of clinical efficacy and patient tolerance. When considering the efficacy of anti-epileptic medications, it is necessary to consider the patient's unique metabolism, side-effect tolerance, and overall response to therapy. Suggested therapeutic ranges should be the first reference for the emergency physician. The purpose of this report is to discuss the laboratory values of commonly prescribed antiepileptic medications. Therapeutic ranges, side-effects, and common medication interactions are discussed concerning phenytoin, phenobarbital, carbamezapine, and valproic acid.

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Redesigning an intensive insulin service for patients with type 1 diabetes: a patient consultation exercise

PubMed Central

Ozcan, Seyda; Rogers, Helen; Choudhary, Pratik; Amiel, Stephanie A; Cox, Alison; Forbes, Angus

2013-01-01

Context Providing effective support for patients in using insulin effectively is essential for good diabetes care. For that support to be effective it must reflect and attend to the needs of patients. Purpose To explore the perspectives of adult type 1 diabetes patients on their current diabetes care in order to generate ideas for creating a new patient centered intensive insulin clinic. Methods A multi-method approach was used, comprising: an observational exercise of current clinical care; three focus groups (n = 17); and a survey of service users (n = 419) to test the ideas generated from the observational exercise and focus groups (rating 1 to 5 in terms of importance). The ideas generated by the multi-method approach were organized thematically and mapped onto the Chronic Care Model (CCM). Results The themes and preferences for service redesign in relation to CCM components were: health care organization, there was an interest in having enhanced systems for sharing clinical information; self-management support, patients would like more flexible and easy to access resources and more help with diabetes technology and psychosocial support; delivery system design and clinical information systems, the need for greater integration of care and better use of clinic time; productive relationships, participants would like more continuity; access to health professionals, patient involvement and care planning. The findings from the patient survey indicate high preferences for most of the areas for service enhancement identified in the focus groups and observational exercise. Clinical feedback and professional continuity (median = 5, interquartile range = 1) were the most highly rated. Conclusion The patient consultation process had generated important ideas on how the clinical team and service can improve the care provided. Key areas for service development were: a stronger emphasis of collaborative care planning; improved patient choice in the use of health technology; more resources for self-management support; and a more explicit format for the process of care in the clinic. PMID:23776329

Incremental cost effectiveness evaluation in clinical research.

PubMed

Krummenauer, Frank; Landwehr, I

2005-01-28

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

[Practice and experience in early clinical education of dental students in preventive dentistry].

PubMed

Tao, Dan-ying; Shu, Chen-bin; Pan, Ying; Feng, Xi-ping

2013-02-01

To help dental students acquaint the medical environment, doctor-patient communication and relationship, early clinic education was arranged in our college of stomatology. The interesting topics were chosen to enhance the learning enthusiasm of the students in the teaching practice of preventive dentistry. Students were encouraged to practice the skill of doctor-patient communication. To obtain the satisfactory teaching effect and aim, it was important to pay attention to the aspects in the groups and clinical practice. Early clinic education in preventive dentistry help the students understand the specialty of preventive dentistry.

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

PubMed Central

PhD, Greg Alexander; Staggers, Nancy

2010-01-01

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

Alternative Lipid Emulsions in the Critically Ill: A Systematic Review of the Evidence

PubMed Central

Manzanares, William; Dhaliwal, Rupinder; Jurewitsch, Brian; Stapleton, Renee D.; Jeejeebhoy, Khursheed N.; Heyland, Daren K.

2015-01-01

Introduction Parenteral lipid emulsions (LEs) are commonly rich in long-chain triglycerides (LCT) derived from soybean oil (SO). SO containing emulsions may promote systemic inflammation and therefore may adversely affect clinical outcomes. We hypothesized that alternative oil-based LEs (SO-sparing strategies) may improve clinical outcomes in critically ill adult patients compared to SO emulsion only products. The purpose of this systematic review was to evaluate the effect of parenteral SO-sparing strategies on clinical outcomes in intensive care unit (ICU) patients. Methods We searched computerized databases from 1980 to 2013. We included randomized controlled trials (RCTs) conducted in critically ill adult patients that evaluated SO-sparing strategies versus SO-based LEs in the context of parenteral nutrition (PN). Results A total of 12 RCTs met inclusion criteria. When the results of these RCTs that were statistically aggregated, SO-sparing strategies were associated with clinically important reductions in mortality (risk ratio RR= 0.83, 95% confidence intervals CI 0.62, 1.11, P = 0.20), in duration of ventilation (weighted mean difference, WMD −2.57, 95% CI −5.51, 0.37, P= 0.09), and in ICU length of stay (WMD −2.31, 95% CI −5.28, 0.66, P= 0.13) but none of these differences were statistically significant. SO-sparing strategies had no effect on infectious complications (RR=1.13, 95% CI 0.87, 1.46, P=0.35). Conclusion Alternative oil-based LEs may be associated with clinically important reductions in mortality, duration of ventilation, and ICU LOS but lack of statistical precision precludes any clinical recommendations at this time. Further research is warranted to confirm these potential positive treatment effects. PMID:23812404

Alternative lipid emulsions in the critically ill: a systematic review of the evidence.

PubMed

Manzanares, William; Dhaliwal, Rupinder; Jurewitsch, Brian; Stapleton, Renee D; Jeejeebhoy, Khursheed N; Heyland, Daren K

2013-10-01

Parenteral lipid emulsions (LEs) are commonly rich in long-chain triglycerides derived from soybean oil (SO). SO-containing emulsions may promote systemic inflammation and therefore may adversely affect clinical outcomes. We hypothesized that alternative oil-based LEs (SO-sparing strategies) may improve clinical outcomes in critically ill adult patients compared to products containing SO emulsion only. The purpose of this systematic review was to evaluate the effect of parenteral SO-sparing strategies on clinical outcomes in intensive care unit (ICU) patients. We searched computerized databases from 1980 to 2013. We included randomized controlled trials (RCTs) conducted in critically ill adult patients that evaluated SO-sparing strategies versus SO-based LEs in the context of parenteral nutrition. A total of 12 RCTs met the inclusion criteria. When the results of these RCTs were statistically aggregated, SO-sparing strategies were associated with clinically important reductions in mortality (risk ratio, RR 0.83; 95 % confidence intervals, CI 0.62, 1.11; P = 0.20), in duration of ventilation (weighted mean difference, WMD -2.57; 95 % CI -5.51, 0.37; P = 0.09), and in ICU length of stay (LOS) (WMD -2.31; 95 % CI -5.28, 0.66; P = 0.13) but none of these differences were statistically significant. SO-sparing strategies had no effect on infectious complications (RR 1.13; 95 % CI 0.87, 1.46; P = 0.35). Alternative oil-based LEs may be associated with clinically important reductions in mortality, duration of ventilation, and ICU LOS but lack of statistical precision precludes any clinical recommendations at this time. Further research is warranted to confirm these potential positive treatment effects.

Coping - Care for Childhood Cancer Survivors

Cancer.gov

Survivorship care for children who have been treated for cancer is important. Get your child's treatment summary, survivorship plan, and recommendations on follow-up care clinics. Learn about long-term and late effects.

Comparison of untreated adolescent idiopathic scoliosis with normal controls: a review and statistical analysis of the literature.

PubMed

Rushton, Paul R P; Grevitt, Michael P

2013-04-20

Review and statistical analysis of studies evaluating health-related quality of life (HRQOL) in adolescents with untreated adolescent idiopathic scoliosis (AIS) using Scoliosis Research Society (SRS) outcomes. To apply normative values and minimum clinical important differences for the SRS-22r to the literature. Identify whether the HRQOL of adolescents with untreated AIS differs from unaffected peers and whether any differences are clinically relevant. The effect of untreated AIS on adolescent HRQOL is uncertain. The lack of published normative values and minimum clinical important difference for the SRS-22r has so far hindered our interpretation of previous studies. The publication of this background data allows these studies to be re-examined. Using suitable inclusion criteria, a literature search identified studies examining HRQOL in untreated adolescents with AIS. Each cohort was analyzed individually. Statistically significant differences were identified by using 95% confidence intervals for the difference in SRS-22r domain mean scores between the cohorts with AIS and the published data for unaffected adolescents. If the lower bound of the confidence interval was greater than the minimum clinical important difference, the difference was considered clinically significant. Of the 21 included patient cohorts, 81% reported statistically worse pain than those unaffected. Yet in only 5% of cohorts was this difference clinically important. Of the 11 cohorts included examining patient self-image, 91% reported statistically worse scores than those unaffected. In 73% of cohorts this difference was clinically significant. Affected cohorts tended to score well in function/activity and mental health domains and differences from those unaffected rarely reached clinically significant values. Pain and self-image tend to be statistically lower among cohorts with AIS than those unaffected. The literature to date suggests that it is only self-image which consistently differs clinically. This should be considered when assessing the possible benefits of surgery.

Medical Student Bias and Care Recommendations for an Obese versus Non-Obese Virtual Patient

PubMed Central

Persky, Susan; Eccleston, Collette P.

2010-01-01

Objective This study examined the independent effect of a patient's weight on medical students' attitudes, beliefs, and interpersonal behavior toward the patient, in addition to the clinical recommendations they make for her care. Design Seventy-six clinical-level medical students were randomly assigned to interact with a digital, virtual female patient who was visibly either obese or non-obese. Methods Interactions with the patient took place in an immersive virtual clinical environment (i.e., virtual reality) which allowed standardization of all patient behaviors and characteristics except for weight. Visual contact behavior was automatically recorded during the interaction. Afterward, participants filled out a battery of self-report questionnaires. Results Analyses revealed more negative stereotyping, less anticipated patient adherence, worse perceived health, more responsibility attributed for potentially weight-related presenting complaints, and less visual contact directed toward the obese version of a virtual patient than the non-obese version of the patient. In contrast, there was no clear evidence of bias in clinical recommendations made for the patient's care. Conclusion Biases in attitudes, beliefs, and interpersonal behavior have important implications because they can influence the tone of clinical encounters and rapport in the patient-provider relationship, which can have important downstream consequences. Gaining a clear understanding of the nature and source of weight bias in the clinical encounter is an important first step toward development of strategies to address it. PMID:20820169

Observational Research Opportunities and Limitations

PubMed Central

Boyko, Edward J.

2013-01-01

Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principle engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision. PMID:24055326

Observational research--opportunities and limitations.

PubMed

Boyko, Edward J

2013-01-01

Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principal engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision. © 2013.

[Isotretinoin embryopathy: An entity that can be avoided].

PubMed

Cammarata-Scalisi, Francisco; Nieves, Dairelis; Avendaño, Andrea; Lacruz-Rengel, María A; Alviárez, Karelys; Dávila, Francys; Yavuz, Izzet; Callea, Michele

2018-04-01

Isotretinoin is the most effective drug in the treatment of severe recalcitrant nodulocystic acne. However, treatment with this drug is associated with adverse effects, the most severe being teratogenesis. It has been estimated that 40% of pregnancies exposed to isotretinoin present spontaneous abortion and 35% develop embryopathy. We present the case of a newborn with a history of prenatal exposure to isotretinoin, a clinical entity that can be avoided, with severe congenital defects in the central nervous system and important facial dysmorphisms, with unfavorable clinical course. Sociedad Argentina de Pediatría.

Clinical efficacy analysis of the mouth rinsing with pomegranate and chamomile plant extracts in the gingival bleeding reduction.

PubMed

Batista, Ana Luzia Araújo; Lins, Ruthineia Diógenes Alves Uchôa; de Souza Coelho, Renata; do Nascimento Barbosa, Danielle; Moura Belém, Nayara; Alves Celestino, Frayni Josley

2014-02-01

Medicinal plants represent important therapeutic resources to health restoration, including the use of herbal products in the mouth conditions treatment. A randomized controlled clinical trial was performed in order to evaluate the effectiveness of mouth rinse with pomegranate and chamomile plant extracts, against chlorhexidine 0.12% in the gingiva bleeding condition. The mouth rinses with the herbal products were effective for this case, showing thus, antimicrobial and anti-inflammatory properties similar to that of chlorhexidine 0.12%. Copyright © 2013 Elsevier Ltd. All rights reserved.

Importance of Pharmaceutical Training and Clinical Research at Medical Facilities.

PubMed

Myotoku, Michiaki

2017-01-01

To respond to advancements in medical techniques, and to address the separation of medical and dispensary practices, clinical professors are required to educate human resource staff to become highly-skilled pharmacists. For this purpose, it is extremely important for these professors to learn about cutting-edge practical skills and knowledge, as well as to advance their expertise. In addition, they need to conduct clinical research in cooperation with relevant facilities. As our university does not have its own hospital or pharmacy, it is important to provide training for clinical professors in clinical facilities. Such training mainly involves medical teams' in-hospital rounds and participation in conferences (nutrition support team; NST), operation of the pharmacy department, and intervention targeting improvement in the department's duties. We have conducted collaborative studies, provided research instructions, implemented studies aimed at improving the department's work (pharmacists appointed on wards at all times to ensure medical safety) as well as studies regarding team medical care (nutritional evaluation during outpatient chemotherapy), and resolved issues regarding this work (drug solution mixability in a hand-held constant infusion pump, and a safe pump-filling methods). Thus, it has become possible to keep track of the current state of a pharmacists' work within team medical care, to access information about novel drugs, to view clinical and prescription-claim data, to cooperate with other professionals (e.g., doctors and nurses), to promote pharmacists' self-awareness of their roles in cooperative medical practice, and to effectively maintain the hospital's clinical settings.

The Importance of Interprofessional Education for Students in Communication Sciences and Disorders

ERIC Educational Resources Information Center

Goldberg, Lynette R.

2015-01-01

Interprofessional education (IPE) is recognized as a critical component in preparing students for effective interprofessional practice in health care. IPE is supported by the American Speech-Language-Hearing Association and students' competence in interprofessional practice is expected by clinical supervisors for effective work in any…

Neuroimaging Week: A Novel, Engaging, and Effective Curriculum for Teaching Neuroimaging to Junior Psychiatric Residents

ERIC Educational Resources Information Center

Downar, Jonathan; Krizova, Adriana; Ghaffar, Omar; Zaretsky, Ari

2010-01-01

Objective: Neuroimaging techniques are increasingly important in psychiatric research and clinical practice, but few postgraduate psychiatry programs offer formal training in neuroimaging. To address this need, the authors developed a course to prepare psychiatric residents to use neuroimaging techniques effectively in independent practice.…

Immunomodulatory effect of morphine: therapeutic implications.

PubMed

Dinda, Amit; Gitman, Michael; Singhal, Pravin C

2005-07-01

The immunosuppressive as well as modulatory effects of morphine have been known in clinical medicine for > 100 years. Recent developments in molecular immunology, including experiments in mu (mu) opioid receptor knockout mice has led to a better understanding of central and peripheral mechanisms involved in this process. Though there is a large volume of literature documenting adverse effects of immunosupression following the use of morphine, several reports confirm its potential usefulness as an immunomodulator. In vitro and in vivo animal experiments have demonstrated wide-spectrum effects of morphine, including anti-inflammatory, antifibrotic, antitumour, cardioprotective and renoprotective. Immunomodulation is an important field in modern medicine with rapid advancement in recent years. Though a final statement regarding the clinical relevance of morphine-induced immunomodulation cannot be made at this juncture, nevertheless, it is worthwhile to review current developments. It may encourage further clinical studies to elucidate the influence of morphine treatment on immune regulation in different specialties of medicine.

The timing of exposure in clinic-based treatment for childhood anxiety disorders.

PubMed

Gryczkowski, Michelle R; Tiede, Michael S; Dammann, Julie E; Jacobsen, Amy Brown; Hale, Lisa R; Whiteside, Stephen P H

2013-03-01

The present study examines treatment length and timing of exposure from two child anxiety disorders clinics. Data regarding symptoms and treatment characteristics for 28 youth were prospectively obtained through self, parent, and therapist report at each session. Information regarding length of treatment, timing of exposure initiation, and drop-out rates were compared with those obtained through efficacy and effectiveness trials of manualized treatment for anxious youth. Findings from the authors' clinical data revealed significantly shorter treatment duration with exposures implemented sooner than in the previous studies. Dropout rates were significantly higher than in the efficacy trial but comparable with the effectiveness trial. Outcome data from a subset of eight patients revealed large effect sizes. These findings suggest that effective treatment can be shorter and more focused on exposure than is often outlined in manuals and have important implications for outcome research and dissemination.

Three combinations of manual therapy techniques within naprapathy in the treatment of neck and/or back pain: a randomized controlled trial.

PubMed

Paanalahti, Kari; Holm, Lena W; Nordin, Margareta; Höijer, Jonas; Lyander, Jessica; Asker, Martin; Skillgate, Eva

2016-04-23

Manual therapy as spinal manipulation, spinal mobilization, stretching and massage are common treatment methods for neck and back pain. The objective was to compare the treatment effect on pain intensity, pain related disability and perceived recovery from a) naprapathic manual therapy (spinal manipulation, spinal mobilization, stretching and massage) to b) naprapathic manual therapy without spinal manipulation and to c) naprapathic manual therapy without stretching for male and female patients seeking care for back and/or neck pain. Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan - the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes. At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately. The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option. Current Controlled Trials ISRCTN92249294.

Identification and Prioritization of Important Attributes of Disease-Modifying Drugs in Decision Making among Patients with Multiple Sclerosis: A Nominal Group Technique and Best-Worst Scaling.

PubMed

Kremer, Ingrid E H; Evers, Silvia M A A; Jongen, Peter J; van der Weijden, Trudy; van de Kolk, Ilona; Hiligsmann, Mickaël

2016-01-01

Understanding the preferences of patients with multiple sclerosis (MS) for disease-modifying drugs and involving these patients in clinical decision making can improve the concordance between medical decisions and patient values and may, subsequently, improve adherence to disease-modifying drugs. This study aims first to identify which characteristics-or attributes-of disease-modifying drugs influence patients´ decisions about these treatments and second to quantify the attributes' relative importance among patients. First, three focus groups of relapsing-remitting MS patients were formed to compile a preliminary list of attributes using a nominal group technique. Based on this qualitative research, a survey with several choice tasks (best-worst scaling) was developed to prioritize attributes, asking a larger patient group to choose the most and least important attributes. The attributes' mean relative importance scores (RIS) were calculated. Nineteen patients reported 34 attributes during the focus groups and 185 patients evaluated the importance of the attributes in the survey. The effect on disease progression received the highest RIS (RIS = 9.64, 95% confidence interval: [9.48-9.81]), followed by quality of life (RIS = 9.21 [9.00-9.42]), relapse rate (RIS = 7.76 [7.39-8.13]), severity of side effects (RIS = 7.63 [7.33-7.94]) and relapse severity (RIS = 7.39 [7.06-7.73]). Subgroup analyses showed heterogeneity in preference of patients. For example, side effect-related attributes were statistically more important for patients who had no experience in using disease-modifying drugs compared to experienced patients (p < .001). This study shows that, on average, patients valued effectiveness and unwanted effects as most important. Clinicians should be aware of the average preferences but also that attributes of disease-modifying drugs are valued differently by different patients. Person-centred clinical decision making would be needed and requires eliciting individual preferences.

Identification and Prioritization of Important Attributes of Disease-Modifying Drugs in Decision Making among Patients with Multiple Sclerosis: A Nominal Group Technique and Best-Worst Scaling

PubMed Central

Kremer, Ingrid E. H.; van der Weijden, Trudy; van de Kolk, Ilona

2016-01-01

Objectives Understanding the preferences of patients with multiple sclerosis (MS) for disease-modifying drugs and involving these patients in clinical decision making can improve the concordance between medical decisions and patient values and may, subsequently, improve adherence to disease-modifying drugs. This study aims first to identify which characteristics–or attributes–of disease-modifying drugs influence patients´ decisions about these treatments and second to quantify the attributes’ relative importance among patients. Methods First, three focus groups of relapsing-remitting MS patients were formed to compile a preliminary list of attributes using a nominal group technique. Based on this qualitative research, a survey with several choice tasks (best-worst scaling) was developed to prioritize attributes, asking a larger patient group to choose the most and least important attributes. The attributes’ mean relative importance scores (RIS) were calculated. Results Nineteen patients reported 34 attributes during the focus groups and 185 patients evaluated the importance of the attributes in the survey. The effect on disease progression received the highest RIS (RIS = 9.64, 95% confidence interval: [9.48–9.81]), followed by quality of life (RIS = 9.21 [9.00–9.42]), relapse rate (RIS = 7.76 [7.39–8.13]), severity of side effects (RIS = 7.63 [7.33–7.94]) and relapse severity (RIS = 7.39 [7.06–7.73]). Subgroup analyses showed heterogeneity in preference of patients. For example, side effect-related attributes were statistically more important for patients who had no experience in using disease-modifying drugs compared to experienced patients (p < .001). Conclusions This study shows that, on average, patients valued effectiveness and unwanted effects as most important. Clinicians should be aware of the average preferences but also that attributes of disease-modifying drugs are valued differently by different patients. Person-centred clinical decision making would be needed and requires eliciting individual preferences. PMID:27812117

Curcuma as a functional food in the control of cancer and inflammation.

PubMed

Schaffer, Moshe; Schaffer, Pamela M; Zidan, Jamal; Bar Sela, Gil

2011-11-01

Several nutritional compounds are the focus of public attention because of their potential beneficial health effects. Turmeric is a spice that comes from the root Curcuma longa. Extensive research over the past half century and especially in recent years has revealed important functions of curcumin and a timely review of clinical state-of-the-art using curcumin. In-vitro and in-vivo research has shown various activities, such as anti-inflammatory, antiviral, antifungal, cytokines release, antioxidant, immunomodulatory, enhancing of the apoptotic process, and antiangiogenic properties. Curcumin also have been shown to be a mediator of chemo-resistance and radio-resistance. Various in-vitro and in-vivo and scarce number of clinical studies on curcumin were identified. The various effects and properties of curcumin are summarized in this review, including preclinical and especially clinical studies. This review concentrates on recent knowledge and research with curcumin clinical applications, and clinical studies, focusing on studies published between 2008 and 2011 demonstrating the gap between preclinical and clinical research.

Semantic Role Labeling of Clinical Text: Comparing Syntactic Parsers and Features

PubMed Central

Zhang, Yaoyun; Jiang, Min; Wang, Jingqi; Xu, Hua

2016-01-01

Semantic role labeling (SRL), which extracts shallow semantic relation representation from different surface textual forms of free text sentences, is important for understanding clinical narratives. Since semantic roles are formed by syntactic constituents in the sentence, an effective parser, as well as an effective syntactic feature set are essential to build a practical SRL system. Our study initiates a formal evaluation and comparison of SRL performance on a clinical text corpus MiPACQ, using three state-of-the-art parsers, the Stanford parser, the Berkeley parser, and the Charniak parser. First, the original parsers trained on the open domain syntactic corpus Penn Treebank were employed. Next, those parsers were retrained on the clinical Treebank of MiPACQ for further comparison. Additionally, state-of-the-art syntactic features from open domain SRL were also examined for clinical text. Experimental results showed that retraining the parsers on clinical Treebank improved the performance significantly, with an optimal F1 measure of 71.41% achieved by the Berkeley parser. PMID:28269926

Clinical Practice Guideline Selection, Development, Implementation, and Evaluation

DTIC Science & Technology

2000-02-01

interventions for a particular diagnosis” (Henning, 1997) developed by members of the hospital staff. They can be Clinical Practice Guidelines6 conceptualized...health care environment , it is more important than ever for health care organizations to select the most cost-effective procedures, and to continuously...of the studies regarding the targeted illness/injury will enable this team to identify those interventions strongly supported by significant

The Outcomes of Peer-Led Diabetes Education in Comparison to Education Delivered by Health Professionals in Iranian Patients

ERIC Educational Resources Information Center

Ahmadi, Zakieh; Sadeghi, Tabandeh; Loripoor, Marzeyeh

2018-01-01

Education is an important aspect of care for diabetic patients. This study aimed to compare the effect of education by health care provider and peer on self-care behaviors among Iranian patients with diabetes. In this clinical randomized control trial, we enrolled 120 patients with type 2 diabetes who were referred to the Diabetes Clinic at a…

Clinical importance of voluntary and induced Bennett movement.

PubMed

Tupac, R G

1978-07-01

A total of 136 dentulous patients were divided into three groups for purposes of quantitative pantographic comparison of voluntary and induced Bennett movement. The effects of patient age and operator experience on recording the Bennett movement were also studied. The results indicates that for patients studied with Bennett movement iduced in the manner described: 1. Experienced operators can obtain more induced Bennett movement that inexperienced operators. 2. Inducing Bennett movement has a greater effect on the immediate side shift component than it has on the progressive side shift component. 3. For older individuals the amount and direction of induced immediate side shift is greater than for younger patients, statistically highly significant, and therefore clinically important. In conclusion, if the objective of a pantographic survey is to record the complete capacity of the joint to move, *lateral jaw movements must be induced.

Power analysis on the time effect for the longitudinal Rasch model.

PubMed

Feddag, M L; Blanchin, M; Hardouin, J B; Sebille, V

2014-01-01

Statistics literature in the social, behavioral, and biomedical sciences typically stress the importance of power analysis. Patient Reported Outcomes (PRO) such as quality of life and other perceived health measures (pain, fatigue, stress,...) are increasingly used as important health outcomes in clinical trials or in epidemiological studies. They cannot be directly observed nor measured as other clinical or biological data and they are often collected through questionnaires with binary or polytomous items. The Rasch model is the well known model in the item response theory (IRT) for binary data. The article proposes an approach to evaluate the statistical power of the time effect for the longitudinal Rasch model with two time points. The performance of this method is compared to the one obtained by simulation study. Finally, the proposed approach is illustrated on one subscale of the SF-36 questionnaire.

Patient safety competencies in undergraduate nursing students: a rapid evidence assessment.

PubMed

Bianchi, Monica; Bressan, Valentina; Cadorin, Lucia; Pagnucci, Nicola; Tolotti, Angela; Valcarenghi, Dario; Watson, Roger; Bagnasco, Annamaria; Sasso, Loredana

2016-12-01

To identify patient safety competencies, and determine the clinical learning environments that facilitate the development of patient safety competencies in nursing students. Patient safety in nursing education is of key importance for health professional environments, settings and care systems. To be effective, safe nursing practice requires a good integration between increasing knowledge and the different clinical practice settings. Nurse educators have the responsibility to develop effective learning processes and ensure patient safety. Rapid Evidence Assessment. MEDLINE, CINAHL, SCOPUS and ERIC were searched, yielding 500 citations published between 1 January 2004-30 September 2014. Following the Rapid Evidence Assessment process, 17 studies were included in this review. Hawker's (2002) quality assessment tool was used to assess the quality of the selected studies. Undergraduate nursing students need to develop competencies to ensure patient safety. The quality of the pedagogical atmosphere in the clinical setting has an important impact on the students' overall level of competence. Active student engagement in clinical processes stimulates their critical reasoning, improves interpersonal communication and facilitates adequate supervision and feedback. Few studies describe the nursing students' patient safety competencies and exactly what they need to learn. In addition, studies describe only briefly which clinical learning environments facilitate the development of patient safety competencies in nursing students. Further research is needed to identify additional pedagogical strategies and the specific characteristics of the clinical learning environments that encourage the development of nursing students' patient safety competencies. © 2016 John Wiley & Sons Ltd.

A putative biomarker signature for clinically effective AKT inhibition: correlation of in vitro, in vivo and clinical data identifies the importance of modulation of the mTORC1 pathway.

PubMed

Cheraghchi-Bashi, Azadeh; Parker, Christine A; Curry, Ed; Salazar, Jean-Frederic; Gungor, Hatice; Saleem, Azeem; Cunnea, Paula; Rama, Nona; Salinas, Cristian; Mills, Gordon B; Morris, Shannon R; Kumar, Rakesh; Gabra, Hani; Stronach, Euan A

2015-12-08

Our identification of dysregulation of the AKT pathway in ovarian cancer as a platinum resistance specific event led to a comprehensive analysis of in vitro, in vivo and clinical behaviour of the AKT inhibitor GSK2141795. Proteomic biomarker signatures correlating with effects of GSK2141795 were developed using in vitro and in vivo models, well characterised for related molecular, phenotypic and imaging endpoints. Signatures were validated in temporally paired biopsies from patients treated with GSK2141795 in a clinical study. GSK2141795 caused growth-arrest as single agent in vitro, enhanced cisplatin-induced apoptosis in vitro and reduced tumour volume in combination with platinum in vivo. GSK2141795 treatment in vitro and in vivo resulted in ~50-90% decrease in phospho-PRAS40 and 20-80% decrease in fluoro-deoxyglucose (FDG) uptake. Proteomic analysis of GSK2141795 in vitro and in vivo identified a signature of pathway inhibition including changes in AKT and p38 phosphorylation and total Bim, IGF1R, AR and YB1 levels. In patient biopsies, prior to treatment with GSK2141795 in a phase 1 clinical trial, this signature was predictive of post-treatment changes in the response marker CA125. Development of this signature represents an opportunity to demonstrate the clinical importance of AKT inhibition for re-sensitisation of platinum resistant ovarian cancer to platinum.

Effects of an intensive clinical skills course on senior nursing students' self-confidence and clinical competence: A quasi-experimental post-test study.

PubMed

Park, Soohyun

2018-02-01

To foster nursing professionals, nursing education requires the integration of knowledge and practice. Nursing students in their senior year experience considerable stress in performing the core nursing skills because, typically, they have limited opportunities to practice these skills in their clinical practicum. Therefore, nurse educators should revise the nursing curricula to focus on core nursing skills. To identify the effect of an intensive clinical skills course for senior nursing students on their self-confidence and clinical competence. A quasi-experimental post-test study. A university in South Korea during the 2015-2016 academic year. A convenience sample of 162 senior nursing students. The experimental group (n=79) underwent the intensive clinical skills course, whereas the control group (n=83) did not. During the course, students repeatedly practiced the 20 items that make up the core basic nursing skills using clinical scenarios. Participants' self-confidence in the core clinical nursing skills was measured using a 10-point scale, while their clinical competence with these skills was measured using the core clinical nursing skills checklist. Independent t-test and chi-square tests were used to analyze the data. The mean scores in self-confidence and clinical competence were higher in the experimental group than in the control group. This intensive clinical skills courses had a positive effect on senior nursing students' self-confidence and clinical competence for the core clinical nursing skills. This study emphasizes the importance of reeducation using a clinical skills course during the transition from student to nursing professional. Copyright © 2017. Published by Elsevier Ltd.

The intelligent clinical laboratory as a tool to increase cancer care management productivity.

PubMed

Mohammadzadeh, Niloofar; Safdari, Reza

2014-01-01

Studies of the causes of cancer, early detection, prevention or treatment need accurate, comprehensive, and timely cancer data. The clinical laboratory provides important cancer information needed for physicians which influence clinical decisions regarding treatment, diagnosis and patient monitoring. Poor communication between health care providers and clinical laboratory personnel can lead to medical errors and wrong decisions in providing cancer care. Because of the key impact of laboratory information on cancer diagnosis and treatment the quality of the tests, lab reports, and appropriate lab management are very important. A laboratory information management system (LIMS) can have an important role in diagnosis, fast and effective access to cancer data, decrease redundancy and costs, and facilitate the integration and collection of data from different types of instruments and systems. In spite of significant advantages LIMS is limited by factors such as problems in adaption to new instruments that may change existing work processes. Applications of intelligent software simultaneously with existing information systems, in addition to remove these restrictions, have important benefits including adding additional non-laboratory-generated information to the reports, facilitating decision making, and improving quality and productivity of cancer care services. Laboratory systems must have flexibility to change and have the capability to develop and benefit from intelligent devices. Intelligent laboratory information management systems need to benefit from informatics tools and latest technologies like open sources. The aim of this commentary is to survey application, opportunities and necessity of intelligent clinical laboratory as a tool to increase cancer care management productivity.

Responsiveness of the VISA-P scale for patellar tendinopathy in athletes.

PubMed

Hernandez-Sanchez, Sergio; Hidalgo, Ma Dolores; Gomez, Antonia

2014-03-01

Patient-reported outcome measures are increasingly used in sports medicine to assess results after treatment, but interpretability of change for many instruments remains unclear. To define the minimum clinically important difference (MCID) for the Victorian Institute of Sport Assessment scale (VISA-P) in athletes with patellar tendinopathy (PT) who underwent conservative treatment. Ninety-eight athletes with PT were enrolled in the study. Each participant completed the VISA-P at admission, after 1 week, and at the final visit. Athletes also assessed their clinical change at discharge on a 15-point Likert scale. We equated important change with a score of ≥3 (somewhat better). Receiver-operating characteristic (ROC) curve analysis and mean change score were used to determine MCID. Minimal detectable change was calculated. The effect of baseline scores on MCID and different criteria used to define important change were investigated. A Bayesian analysis was used to establish the posterior probability of reporting clinical changes related to MCID value. Athletes with PT who showed an absolute change greater than 13 points in the VISA-P score or 15.4-27% of relative change achieved a minimal important change in their clinical status. This value depended on baseline scores. The probability of a clinical change in a patient was 98% when this threshold was achieved and 45% when MCID was not achieved. Definition of the MCID will enhance the interpretability of changes in the VISA-P score in the athletes with PT, but caution is required when these values are used.

Theta Burst Stimulation in the Rehabilitation of the Upper Limb: A Semirandomized, Placebo-Controlled Trial in Chronic Stroke Patients

PubMed Central

Talelli, Penelope; Wallace, Amanda; Dileone, Michelle; Hoad, Damon; Cheeran, Binith; Oliver, Rupert; VandenBos, Mehdi; Hammerbeck, Ulrike; Barratt, Karen; Gillini, Cecilia; Musumeci, Gabriella; Boudrias, Marie-Hélène; Cloud, Geoffrey C.; Ball, Joanna; Marsden, Jonathan F.; Ward, Nicholas S.; Di Lazzaro, Vincenzo; Greenwood, Richard G.; Rothwell, John C.

2013-01-01

Background Noninvasive cortical stimulation could represent an add-on treatment to enhance motor recovery after stroke. However, its clinical value, including anticipated size and duration of the treatment effects, remains largely unknown. Objective The authors designed a small semi-randomized clinical trial to explore whether long-lasting clinically important gains can be achieved by adding theta burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (TMS), to a rehabilitation program for the hand. Methods A total of 41 chronic stroke patients received excitatory TBS to the ipsilesional hemisphere or inhibitory TBS to the contralesional hemisphere in 2 centers; each active group was compared with a group receiving sham TBS. TBS was followed by physical therapy for 10 working days. Patients and therapists were blinded to the type of TBS. Primary outcome measures (9-hole Peg Test [9HPT], Jebsen Taylor Test [JTT], and grip and pinch-grip dynamometry) were assessed 4, 30, and 90 days post treatment. The clinically important difference was defined as 10% of the maximum score. Results There were no differences between the active treatment and sham groups in any of the outcome measures. All patients achieved small sustainable improvements—9HPT, 5% of maximum (confidence interval [CI] = 3%-7%); JTT, 5.7% (CI = 3%-8%); and grip strength, 6% (CI = 2%-10%)—all below the defined clinically important level. Conclusions Cortical stimulation did not augment the gains from a late rehabilitation program. The effect size anticipated by the authors was overestimated. These results can improve the design of future work on therapeutic uses of TMS. PMID:22412171

Assessment of cognitive safety in clinical drug development

PubMed Central

Roiser, Jonathan P.; Nathan, Pradeep J.; Mander, Adrian P.; Adusei, Gabriel; Zavitz, Kenton H.; Blackwell, Andrew D.

2016-01-01

Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design and statistical analysis, from Phase I through to postmarketing. The crucial issue of how cognition should be assessed is emphasized, especially the sensitivity of measurement. We also consider how best to interpret the magnitude of any identified effects, including comparison with benchmarks. We conclude by discussing strategies for the effective communication of cognitive risks. PMID:26610416

[Effect of RAAS inhibition on stroke prevention].

PubMed

Tanahashi, Norio

2012-09-01

Recently, molecular and experimental studies revealed that the brain possesses its own renin-angiotensin-aldosterone system(RAAS) and the brain angiotensin(Ang) II plays an important role on stroke protection, mediating its effects through stimulation of AT2 and possibly the AT4 receptors. Moreover, the novel ACE2/Ang-(1-7)/Mas receptor axis was found to counterbalance the vasoconstrictive actions of the ACE/Ang II/AT1 receptor. Recent clinical trials indicate that blockade of RAAS has a potential role in stroke prevention, but was not conclusive. More carefully designed large clinical trial are needed to verify blood pressure-independent stroke prevention effect by RAAS inhibition.

Comparative effectiveness research.

PubMed

Hirsch, J A; Schaefer, P W; Romero, J M; Rabinov, J D; Sanelli, P C; Manchikanti, L

2014-09-01

The goal of comparative effectiveness research is to improve health care while dealing with the seemingly ever-rising cost. An understanding of comparative effectiveness research as a core topic is important for neuroradiologists. It can be used in a variety of ways. Its goal is to look at alternative methods of interacting with a clinical condition, ideally, while improving delivery of care. While the Patient-Centered Outcome Research initiative is the most mature US-based foray into comparative effectiveness research, it has been used more robustly in decision-making in other countries for quite some time. The National Institute for Health and Clinical Excellence of the United Kingdom is a noteworthy example of comparative effectiveness research in action. © 2014 by American Journal of Neuroradiology.

Review on research of suppression male fertility and male contraceptive drug development by natural products.

PubMed

Bajaj, Vijay Kumar; Gupta, Radhey S

2013-08-01

Male contraceptive development in the present scenario is most viable aspect of research due to uncontrolled population growth in the world. In this respect investigators are busy to find out a safe male contraceptive drug. Researchers have started their finding for a suitable drug from natural sources because these are safe and easily acceptable for common man, most of natural sources are plants and their products. In this review 137 plants and their effects on reproduction and reproductive physiology are summarized. Some of them have intense effect on male reproductive system and do not produce any side effects. Reproductive toxicological studies are also important aspects of these kinds of researches, so it is important that drugs are safe and widely acceptable. An ideal male contraceptive can influence semen, testes, hormone level, accessory reproductive organs and general physiology of animals and produced some alterations. Many plants in this review are showing antifertility as well as antispermatogenic effects, so these may be used for further study for contraceptives development but it is important to find out the mechanism of reaction and further laboratory and clinical research on some plants are needed for final male contraceptive drug development. In conclusion this review will help for finding suitable plant products for male contraceptive clinical and laboratory studies.

Adherence issues related to sublingual immunotherapy as perceived by allergists

PubMed Central

Scurati, Silvia; Frati, Franco; Passalacqua, Gianni; Puccinelli, Paola; Hilaire, Cecile; Incorvaia, Cristoforo

2010-01-01

Objectives: Sublingual immunotherapy (SLIT) is a viable alternative to subcutaneous immunotherapy to treat allergic rhinitis and asthma, and is widely used in clinical practice in many European countries. The clinical efficacy of SLIT has been established in a number of clinical trials and meta-analyses. However, because SLIT is self-administered by patients without medical supervision, the degree of patient adherence with treatment is still a concern. The objective of this study was to evaluate the perception by allergists of issues related to SLIT adherence. Methods: We performed a questionnaire-based survey of 296 Italian allergists, based on the adherence issues known from previous studies. The perception of importance of each item was assessed by a VAS scale ranging from 0 to 10. Results: Patient perception of clinical efficacy was considered the most important factor (ranked 1 by 54% of allergists), followed by the possibility of reimbursement (ranked 1 by 34%), and by the absence of side effects (ranked 1 by 21%). Patient education, regular follow-up, and ease of use of SLIT were ranked first by less than 20% of allergists. Conclusion: These findings indicate that clinical efficacy, cost, and side effects are perceived as the major issues influencing patient adherence to SLIT, and that further improvement of adherence is likely to be achieved by improving the patient information provided by prescribers. PMID:20622914

Education strategies to foster health professional students' clinical reasoning skills.

PubMed

Rochmawati, Erna; Wiechula, Rick

2010-06-01

Clinical reasoning is an important skill for health professionals that should be developed to achieve high levels of expertise. Several education strategies have been suggested for implementation by health professional educators to foster their students' clinical reasoning skills. The strategies have included the following: problem-based learning, the integrative curriculum, reflection, and concept mapping. This review assesses which is the most effective education strategy for developing the clinical reasoning skills of health professional students. Four publications, from a total of 692 identified records, were included. Overall, this review was not able to make a final conclusion to answer the question. Therefore, there is a need to conduct more studies with larger samples and to undertake research that evaluates the following aspects: more alternate education interventions, variations in the delivery of education interventions, and the cost-effectiveness of implementing education strategies.

Clinical and translational research in global health and emergency care: a research agenda.

PubMed

Runyon, Michael S; Sawe, Hendry R; Levine, Adam C; Pousson, Amelia; House, Darlene R; Agrawal, Pooja; Osei-Ampofo, Maxwell; Weiner, Scott G; Douglass, Katherine

2013-12-01

As policy-makers increasingly recognize emergency care to be a global health priority, the need for high-quality clinical and translational research in this area continues to grow. As part of the proceedings of the 2013 Academic Emergency Medicine consensus conference, this article discusses the importance of: 1) including clinical and translational research in the initial emergency care development plan, 2) defining the burden of acute disease and the barriers to conducting research in resource-limited settings, 3) assessing the appropriateness and effectiveness of local and global acute care guidelines within the local context, 4) studying the local research infrastructure needs to understand the best methods to build a sustainable research infrastructure, and 5) studying the long-term effects of clinical research programs on health care systems. © 2013 by the Society for Academic Emergency Medicine.

Beyond lung function in COPD management: effectiveness of LABA/LAMA combination therapy on patient-centred outcomes.

PubMed

van der Molen, Thys; Cazzola, Mario

2012-03-01

Bronchodilators are central to the management of chronic obstructive pulmonary disease (COPD). Clinical studies combining different classes of bronchodilators, in particular a long-acting muscarinic antagonist (LAMA) and a long-acting β2-agonist (LABA), have demonstrated greater improvements in lung function (forced expiratory volume in 1 second, FEV1) in patients with COPD than monotherapy. FEV1 has served as an important diagnostic measurement of COPD, and the majority of clinical studies of currently available pharmacotherapies grade effectiveness of treatment regimens based on improvements in FEV1. However, FEV1 alone may not adequately reflect the overall health status of the patient. Published evidence suggests that LABA/LAMA combination therapies demonstrate greater improvements in patient-centred outcomes such as dyspnoea, symptoms, rescue medication use, and quality of life than individual drugs used alone. Evaluating patient-centred outcomes associated with COPD is likely to play an important role in future research as a measure of overall treatment effectiveness. Raising awareness of the importance of outcomes beyond lung function alone, particularly in primary care where most patients initially present themselves for medical evaluation, should form a fundamental part of a more holistic approach to COPD management.

Effects of occupational stress on the gastrointestinal tract

PubMed Central

Huerta-Franco, María-Raquel; Vargas-Luna, Miguel; Tienda, Paola; Delgadillo-Holtfort, Isabel; Balleza-Ordaz, Marco; Flores-Hernandez, Corina

2013-01-01

The aim of this review is to provide a general overview of the relationship between occupational stress and gastrointestinal alterations. The International Labour Organization suggests occupational health includes psychological aspects to achieve mental well-being. However, the definition of health risks for an occupation includes biological, chemical, physical and ergonomic factors but does not address psychological stress or other affective disorders. Nevertheless, multiple investigations have studied occupational stress and its physiological consequences, focusing on specific risk groups and occupations considered stressful. Among the physiological effects of stress, gastrointestinal tract (GIT) alterations are highly prevalent. The relationship between occupational stress and GIT diseases is evident in everyday clinical practice; however, the usual strategy is to attack the effects but not the root of the problem. That is, in clinics, occupational stress is recognized as a source of GIT problems, but employers do not ascribe it enough importance as a risk factor, in general, and for gastrointestinal health, in particular. The identification, stratification, measurement and evaluation of stress and its associated corrective strategies, particularly for occupational stress, are important topics to address in the near future to establish the basis for considering stress as an important risk factor in occupational health. PMID:24244879

Placebo Mechanisms of Manual Therapy: A Sheep in Wolf's Clothing?

PubMed

Bialosky, Joel E; Bishop, Mark D; Penza, Charles W

2017-05-01

When a physical therapist provides a manual therapy (MT) intervention for a patient presenting with pain and the patient experiences a positive clinical outcome, we cannot answer as to why this occurs. Would we continue to devote valuable time and financial resources to learning and improving our skills in providing MT interventions if the related clinical outcomes were placebo responses? In this Viewpoint, the authors conceptualize placebo as an active and important mechanism of MT and argue that placebo mechanisms deserve consideration as an important component of the treatment effect. J Orthop Sports Phys Ther 2017;47(5):301-304. doi:10.2519/jospt.2017.0604.

Athletic Training Clinical Instructors as Situational Leaders

PubMed Central

Meyer, Linda Platt

2002-01-01

Objective: To present Situational Leadership as a model that can be implemented by clinical instructors during clinical education. Effective leadership occurs when the leadership style is matched with the observed followers' characteristics. Effective leaders anticipate and assess change and adapt quickly and grow with the change, all while leading followers to do the same. As athletic training students' levels of readiness change, clinical instructors also need to transform their leadership styles and strategies to match the students' ever-changing observed needs in different situations. Data Sources: CINAHL (1982–2002), MEDLINE (1990–2001), SPORT Discus (1949–2002), ERIC (1966–2002), and Internet Web sites were searched. Search terms included leadership, situational leadership, clinical instructors and leadership, teachers as leaders, and clinical education. Data Synthesis: Situational Leadership is presented as a leadership model to be used by clinical instructors while teaching and supervising athletic training students in the clinical setting. This model can be implemented to improve the clinical-education process. Situational leaders, eg, clinical instructors, must have the flexibility and range of skills to vary their leadership styles to match the challenges that occur while teaching athletic training students. Conclusions/Recommendations: This leadership style causes the leader to carry a substantial responsibility to lead while giving power away. Communication is one of the most important leadership skills to develop to become an effective leader. It is imperative for the future of the profession that certified athletic trainers continue to develop effective leadership skills to address the changing times in education and expectations of the athletic training profession. PMID:12937555

The use of clinical trials in comparative effectiveness research on mental health.

PubMed

Blanco, Carlos; Rafful, Claudia; Olfson, Mark

2013-08-01

A large body of comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health. Examination of three ongoing randomized clinical trials in psychiatry addressing issues that would pose difficulties for nonexperimental CER methods. Existing statistical approaches to nonexperimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout. Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult-to-reach populations, or when examining sequential treatments or stepped-care algorithms. Progress in CER on mental health will require careful consideration of appropriate selection between clinical trials and nonexperimental designs and on allocation of research resources to optimally inform key treatment decisions for each patient. Copyright © 2013 Elsevier Inc. All rights reserved.

Diagnostic criteria, severity classification and guidelines of systemic sclerosis.

PubMed

Asano, Yoshihide; Jinnin, Masatoshi; Kawaguchi, Yasushi; Kuwana, Masataka; Goto, Daisuke; Sato, Shinichi; Takehara, Kazuhiko; Hatano, Masaru; Fujimoto, Manabu; Mugii, Naoki; Ihn, Hironobu

2018-06-01

Several effective drugs have been identified for the treatment of systemic sclerosis (SSc). However, in advanced cases, not only their effectiveness is reduced but they may be also harmful due to their side-effects. Therefore, early diagnosis and early treatment is most important for the treatment of SSc. We established diagnostic criteria for SSc in 2003 and early diagnostic criteria for SSc in 2011, for the purpose of developing evaluation of each organ in SSc. Moreover, in November 2013, the American College of Rheumatology and the European Rheumatology Association jointly developed new diagnostic criteria for increasing their sensitivity and specificity, so we revised our diagnostic criteria and severity classification of SSc. Furthermore, we have revised the clinical guideline based on the newest evidence. In particular, the clinical guideline was established by clinical questions based on evidence-based medicine according to the New Minds Clinical Practice Guideline Creation Manual (version 1.0). We aimed to make the guideline easy to use and reliable based on the newest evidence, and to present guidance as specific as possible for various clinical problems in treatment of SSc. © 2018 Japanese Dermatological Association.

The challenge and promise of anti-epileptic therapy development in animal models

PubMed Central

Simonato, Michele; Brooks-Kayal, Amy R; Engel, Jerome; Galanopoulou, Aristea S; Jensen, Frances E; Moshé, Solomon L; O’Brien, Terence J; Pitkanen, Asla; Wilcox, Karen S; French, Jacqueline A

2016-01-01

Translation of successful target and compound validation studies into clinically effective therapies is a major challenge, with potential for costly clinical trial failures. This situation holds true for the epilepsies—complex diseases with different causes and symptoms. Although the availability of predictive animal models has led to the development of effective antiseizure therapies that are routinely used in clinical practice, showing that translation can be successful, several important unmet therapeutic needs still exist. Available treatments do not fully control seizures in a third of patients with epilepsy, and produce substantial side-effects. No treatment can prevent the development of epilepsy in at-risk patients or cure patients with epilepsy. And no specific treatment for epilepsy-associated comorbidities exists. To meet these demands, a redesign of translational approaches is urgently needed. PMID:25127174

Should we use philosophy to teach clinical communication skills?

PubMed

Gerber, Berna

2016-11-16

Effective communication between the doctor and patient is crucial for good quality health care. Yet, this form of communication is often problematic, which may lead to several negative consequences for both patients and doctors. Clinical communication skills have become important components of medical training programmes. The traditional approach is to teach students particular communication skills, such as listening to patients and asking open-ended questions. Despite their importance, such training approaches do not seem to be enough to deliver medical practitioners who are able and committed to communicate effectively with patients. This might be due to the pervasive negative influence of the medical profession's (mistaken) understanding of itself as a natural science on doctor-patient communication. Doctors who have been trained according to a positivist framework may consider their only responsibility to be the physical treatment of physical disorders. They may thus have little regard for the patient's psychological and social world and by extension for communication with the patient and/or their caregivers. To address this problem, I propose a curriculum, based on the academic field of philosophy, for teaching clinical communication.

Should we use philosophy to teach clinical communication skills?

PubMed Central

2016-01-01

Effective communication between the doctor and patient is crucial for good quality health care. Yet, this form of communication is often problematic, which may lead to several negative consequences for both patients and doctors. Clinical communication skills have become important components of medical training programmes. The traditional approach is to teach students particular communication skills, such as listening to patients and asking open-ended questions. Despite their importance, such training approaches do not seem to be enough to deliver medical practitioners who are able and committed to communicate effectively with patients. This might be due to the pervasive negative influence of the medical profession’s (mistaken) understanding of itself as a natural science on doctor–patient communication. Doctors who have been trained according to a positivist framework may consider their only responsibility to be the physical treatment of physical disorders. They may thus have little regard for the patient’s psychological and social world and by extension for communication with the patient and/or their caregivers. To address this problem, I propose a curriculum, based on the academic field of philosophy, for teaching clinical communication. PMID:28155325

Rethinking clinical governance: healthcare professionals' views: a Delphi study.

PubMed

Veenstra, Gepke L; Ahaus, Kees; Welker, Gera A; Heineman, Erik; van der Laan, Maarten J; Muntinghe, Friso L H

2017-01-12

Although the guiding principle of clinical governance states that healthcare professionals are the leading contributors to quality and safety in healthcare, little is known about what healthcare professionals perceive as important for clinical governance. The aim of this study is to clarify this by exploring healthcare professionals' views on clinical governance. Based on a literature search, a list of 99 elements related to clinical governance was constructed. This list was refined, extended and restricted during a three-round Delphi study. The panel of experts was formed of 24 healthcare professionals from an academic hospital that is seen as a leader in terms of its clinical governance expertise in the Netherlands. Rated importance of each element on a four-point scale. The 50 elements that the panel perceived as most important related to adopting a bottom-up approach to clinical governance, ownership, teamwork, learning from mistakes and feedback. The panel did not reach a consensus concerning elements that referred to patient involvement. Elements that referred to a managerial approach to clinical governance and standardisation of work were rejected by the panel. In the views of the panel of experts, clinical governance is a practice-based, value-driven approach that has the goal of delivering the highest possible quality care and ensuring the safety of patients. Bottom-up approaches and effective teamwork are seen as crucial for high quality and safe healthcare. Striving for high quality and safe healthcare is underpinned by continuous learning, shared responsibility and good relationships and collaboration between healthcare professionals, managers and patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Clinical pharmacology of novel anti-Alzheimer disease modifying medications.

PubMed

Caraci, Filippo; Bosco, Paolo; Leggio, Gian Marco; Malaguarnera, Michele; Drago, Filippo; Bucolo, Claudio; Salomone, Salvatore

2013-01-01

In recent years, efforts have been directed to develop "disease-modifying" medications to treat Alzheimer's disease (AD), able to halt or slow the pathological process. Because the earlier the treatment starts, the greater is the possibility of efficacy, it is important to set up biomarkers for early diagnosis of functional brain abnormalities, before the clinical manifestation of the overt disease. Up to now, strategies to develop disease-modifying drugs have mainly targeted β amyloid (Aβ, accumulation, aggregation, clearance) and/or tau protein (phosphorylation and aggregation). Active and passive immunotherapy is the main strategy aimed at increasing Aβ clearance. Unfortunately several candidate diseasemodifying drugs have failed in phase III clinical trials conducted in mild to moderate AD. More recently, in phase III studies, bapineuzumab has been discontinued because it did not prove clinically effective (despite its significant effect on biomarkers), while solaneuzumab has been found effective in slowing AD progression. Several methological problems have been recently pointed out to explain the lack of clinical efficacy of novel disease-modifying drug-treatments; moreover, new insights in pathophysiology of AD give the premise to develop novel drug targeting. Clinical trials recently completed and/or still ongoing are discussed in the present review.

Ocimum basilicum: Antibacterial activity and association study with antibiotics against bacteria of clinical importance.

PubMed

Araújo Silva, Viviane; Pereira da Sousa, Janiere; de Luna Freire Pessôa, Hilzeth; Fernanda Ramos de Freitas, Andrea; Douglas Melo Coutinho, Henrique; Beuttenmuller Nogueira Alves, Larissa; Oliveira Lima, Edeltrudes

2016-01-01

Ocimum basilicum L. (Lamiaceae), popularly known as basil, is part of a group of medicinal plants widely used in cooking and known for its beneficial health properties, possessing significant antioxidant effects, antinociceptive, and others. The objective of this study is to determine the pharmacological effects produced on the bacterial strains Staphylococcus aureus and Pseudomonas aeruginosa when standard antibiotics and O. basilicum essential oil are combined. The extraction of O. basilicum (leaves) components was done by steam distillation. The Minimum inhibitory concentration (MIC) was calculated using microdilution technique, where the oil concentrations varied from 2 to 1024 μg/mL. The combinations of O. basilicum oil with ciprofloxacin or imipenem were analyzed by the checkerboard method where fractional inhibitory concentration (FIC) indices were calculated. Ocimum basilicum essential oil, imipenem, and ciprofloxacin showed respective MIC antibacterial activities of 1024, 4, and 2 μg/mL, against S. aureus. In S. aureus, the oil with imipenem association showed synergistic effect (FIC = 0.0625), while the oil with ciprofloxacin showed antagonism (FIC value = 4.25). In P. aeruginosa, the imipenem/oil association showed additive effect for ATCC strains, and synergism for the clinical strain (FIC values = 0.75 and 0.0625). The association of O. basilicum essential oil with ciprofloxacin showed synergism for clinical strains (FIC value = 0.09). Ocimum basilicum essential oil associated with existing standard antibiotics may increase their antibacterial activity, resulting in a synergistic activity against bacterial strains of clinical importance. The antibacterial activity of O. basilicum essential oil may be associated with linalool.

Monomeric DR2/MOG-35-55 recombinant TCR ligand treats relapses of experimental encephalomyelitis in DR2 transgenic mice.

PubMed

Link, Jason M; Rich, Cathleen M; Korat, Maya; Burrows, Gregory G; Offner, Halina; Vandenbark, Arthur A

2007-04-01

Treatment of human autoimmune diseases such as multiple sclerosis (MS) will likely require agents that can prevent or reverse the inflammatory process that results in clinical relapses and disease progression. We evaluated the ability of a newly designed monomeric recombinant TCR ligand (RTL342M) containing HLA-DR2 peptide-binding domains covalently linked to MOG-35-55 peptide to prevent and treat both the initial episode and subsequent relapses of experimental autoimmune encephalomyelitis (EAE) in HLA-DR2 transgenic mice. Single doses of RTL342M given either i.v. or s.c. to HLA-DR2 mice produced a rapid (within 24 h) and dose-dependent reversal of clinical signs of paralytic EAE, and even a single dose < or = 2 microg could produce a significant treatment effect. Multiple daily doses were even more effective than the same total amount of RTL given as a single dose. By establishing the minimal effective dose, we determined that RTLs may be 50 times more potent than molar equivalent doses of myelin peptide alone. RTL342M given prior to induction of EAE prevented disease in most mice, and the remainder could be successfully retreated with RTL. Most important for clinical application, RTL342M was highly effective for treating EAE relapses when given periodically prior to the relapse or even after relapses had occurred. These data demonstrate the rapid and potent clinical effects of RTL342M at disease onset and during relapses in EAE and establish important principles governing the application of this novel approach as a possible therapy for patients with MS.

Artemisinin as an anticancer drug: Recent advances in target profiling and mechanisms of action.

PubMed

Wong, Yin Kwan; Xu, Chengchao; Kalesh, Karunakaran A; He, Yingke; Lin, Qingsong; Wong, W S Fred; Shen, Han-Ming; Wang, Jigang

2017-11-01

Artemisinin and its derivatives (collectively termed as artemisinins) are among the most important and effective antimalarial drugs, with proven safety and efficacy in clinical use. Beyond their antimalarial effects, artemisinins have also been shown to possess selective anticancer properties, demonstrating cytotoxic effects against a wide range of cancer types both in vitro and in vivo. These effects appear to be mediated by artemisinin-induced changes in multiple signaling pathways, interfering simultaneously with multiple hallmarks of cancer. Great strides have been taken to characterize these pathways and to reveal their anticancer mechanisms of action of artemisinin. Moreover, encouraging data have also been obtained from a limited number of clinical trials to support their anticancer property. However, there are several key gaps in knowledge that continue to serve as significant barriers to the repurposing of artemisinins as effective anticancer agents. This review focuses on important and emerging aspects of this field, highlighting breakthroughs in unresolved questions as well as novel techniques and approaches that have been taken in recent studies. We discuss the mechanism of artemisinin activation in cancer, novel and significant findings with regards to artemisinin target proteins and pathways, new understandings in artemisinin-induced cell death mechanisms, as well as the practical issues of repurposing artemisinin. We believe these will be important topics in realizing the potential of artemisinin and its derivatives as safe and potent anticancer agents. © 2017 Wiley Periodicals, Inc.

Effect of Clothing on Measurement of Bone Mineral Density.

PubMed

McNamara, Elizabeth A; Feldman, Anna Z; Malabanan, Alan O; Abate, Ejigayehu G; Whittaker, LaTarsha G; Yano-Litwin, Amanda; Dorazio, Jolene; Rosen, Harold N

2016-01-01

It is unknown whether allowing patients to have BMD (bone mineral density) studies acquired while wearing radiolucent clothing adlib contributes appreciably to the measurement error seen. To examine this question, a spine phantom was scanned 30 times without any clothing, while draped with a gown, and while draped with heavy winter clothing. The effect on mean BMD and on SD (standard deviation) was assessed. The effect of clothing on mean or SD of the area was not significant. The effect of clothing on mean and SD for BMD was small but significant and was around 1.6% for the mean. However, the effect on BMD precision was much more clinically important. Without clothing the spine phantom had an least significant change of 0.0077 gm/cm(2), while when introducing variability of clothing the least significant change rose as high as 0.0305 gm/cm(2). We conclude that, adding clothing to the spine phantom had a small but statistically significant effect on the mean BMD and on variance of the measurement. It is unlikely that the effect on mean BMD has any clinical significance, but the effect on the reproducibility (precision) of the result is likely clinically significant. Copyright © 2016 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

The Effects of Constraint-Induced Movement Therapy on Activities Important to Independent School Participation of Children with Hemiparesis

ERIC Educational Resources Information Center

Carney, Joan

2012-01-01

This study investigated the efficacy of constraint-induced movement therapy (CI therapy) on activities important to school participation in children with hemiparesis. Four children, ages 4-0 to 7-10 participated in an intensive CI therapy program in a clinical setting. Constraining casts were worn 24 hours daily. Therapy was delivered 6 hours…

Mechanisms of Dexamethasone-Mediated Inhibition of Toll-Like Receptor Signaling Induced by Neisseria meningitidis and Streptococcus pneumoniae▿

PubMed Central

Mogensen, Trine H.; Berg, Randi S.; Paludan, Søren R.; Østergaard, Lars

2008-01-01

Excessive inflammation contributes to the pathogenesis of bacterial meningitis, which remains a serious disease despite treatment with antibiotics. Therefore, anti-inflammatory drugs have important therapeutic potential, and clinical trials have revealed that early treatment with dexamethasone significantly reduces mortality and morbidity from bacterial meningitis. Here we investigate the molecular mechanisms behind the inhibitory effect of dexamethasone upon the inflammatory responses evoked by Neisseria meningitidis and Streptococcus pneumoniae, two of the major causes of bacterial meningitis. The inflammatory cytokine response was dependent on Toll-like receptor signaling and was strongly inhibited by dexamethasone. Activation of the NF-κB pathway was targeted at several levels, including inhibition of IκB phosphorylation and NF-κB DNA-binding activity as well as upregulation of IκBα synthesis. Our data also revealed that the timing of steroid treatment relative to infection was important for achieving strong inhibition, particularly in response to S. pneumoniae. Altogether, we describe important targets of dexamethasone in the inflammatory responses evoked by N. meningitidis and S. pneumoniae, which may contribute to our understanding of the clinical effect and the importance of timing with respect to corticosteroid treatment during bacterial meningitis. PMID:17938219

Building effective service linkages in primary mental health care: a narrative review part 2

PubMed Central

2011-01-01

Background Primary care services have not generally been effective in meeting mental health care needs. There is evidence that collaboration between primary care and specialist mental health services can improve clinical and organisational outcomes. It is not clear however what factors enable or hinder effective collaboration. The objective of this study was to examine the factors that enable effective collaboration between specialist mental health services and primary mental health care. Methods A narrative and thematic review of English language papers published between 1998 and 2009. An expert reference group helped formulate strategies for policy makers. Studies of descriptive and qualitative design from Australia, New Zealand, UK, Europe, USA and Canada were included. Data were extracted on factors reported as enablers or barriers to development of service linkages. These were tabulated by theme at clinical and organisational levels and the inter-relationship between themes was explored. Results A thematic analysis of 30 papers found the most frequently cited group of factors was "partnership formation", specifically role clarity between health care workers. Other factor groups supporting clinical partnership formation were staff support, clinician attributes, clinic physical features and evaluation and feedback. At the organisational level a supportive institutional environment of leadership and change management was important. The expert reference group then proposed strategies for collaboration that would be seen as important, acceptable and feasible. Because of the variability of study types we did not exclude on quality and findings are weighted by the number of studies. Variability in local service contexts limits the generalisation of findings. Conclusion The findings provide a framework for health planners to develop effective service linkages in primary mental health care. Our expert reference group proposed five areas of strategy for policy makers that address organisational level support, joint clinical problem solving, local joint care guidelines, staff training and supervision and feedback. PMID:21435273

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.

Trichuris suis ova in relapsing-remitting multiple sclerosis and clinically isolated syndrome (TRIOMS): study protocol for a randomized controlled trial.

PubMed

Rosche, Berit; Wernecke, Klaus-Dieter; Ohlraun, Stephanie; Dörr, Jan-Markus; Paul, Friedemann

2013-04-25

Trichuris suis ova is a probiotic treatment based on the hygiene hypothesis. It has been demonstrated as safe and effective in autoimmune inflammatory bowel diseases and clinical trials indicate that helminth infections also have an immunomodulatory effect in multiple sclerosis.We hypothesize that administering 2,500 Trichuris suis ova eggs orally every two weeks for 12 months is--due to its immunomodulatory and anti-inflammatory effect--significantly more effective than oral placebo in preventing new T2 and Gd+ lesions, as quantified by cerebral MRI and clinical examination, in relapsing-remitting multiple sclerosis and clinically isolated syndrome. Fifty patients with relapsing-remitting multiple sclerosis or clinically isolated syndrome with clinical activity, not undergoing any standard therapies, will be randomized 1:1 to Trichuris suis ova 2,500 eggs every two weeks or matching placebo. The safety, tolerability and effect on disease activity and in vivo mechanisms of action of Trichuris suis ova in MS will be assessed by neurological, laboratory and immunological exams and magnetic resonance imaging throughout the 12-month treatment period and over a follow-up period of 6 months. Various immunological analyses will be used to assess the overall patient immune response prior to and at varying time points following treatment with Trichuris suis ova. We anticipate that Trichuris suis ova will be well tolerated and more effective than the placebo in preventing new T2 and Gd+ lesions, as quantified by MRI. We also expect the Th1/Th17 proinflammatory response to shift towards the more anti-inflammatory Th2 response. This study has important clinical implications and will involve extensive research on the immunology of helminth therapy. ClinicalTrials.gov: NCT01413243.

Clinical trial design for orthodontists.

PubMed

Pandis, Nikolaos; Cobourne, Martyn T

2013-06-01

High-quality research should form the basis of all clinical practice. Randomized controlled trials currently provide the gold standard for investigating the effectiveness of treatment interventions and these are increasingly being used in orthodontics. Here we discuss the reasons why this form of investigation provides the most useful evidence for assessing treatment outcome. The methods available to achieve true randomization, a fundamental component in the design of these trials, are also discussed. In addition, we focus on how to minimize bias in clinical research, not only during the design and management of a trial, but also when disseminating results. We focus on the importance of using control groups correctly and describe methods that are available to adequately power a trial. Finally, we emphasise the importance of accurate and transparent reporting, which facilitates correct communication and assessment of the evidence.

Uric acid in metabolic syndrome: From an innocent bystander to a central player

PubMed Central

Kanbay, Mehmet; Jensen, Thomas; Solak, Yalcin; Le, Myphuong; Roncal-Jimenez, Carlos; Rivard, Chris; Lanaspa, Miguel A.; Nakagawa, Takahiko; Johnson, Richard J.

2016-01-01

Uric acid, once viewed as an inert metabolic end-product of purine metabolism, has been recently incriminated in a number of chronic disease states, including hypertension, metabolic syndrome, diabetes, non-alcoholic fatty liver disease, and chronic kidney disease. Several experimental and clinical studies support a role for uric acid as a contributory causal factor in these conditions. Here we discuss some of the major mechanisms linking uric acid to metabolic and cardiovascular diseases. At this time the key to understanding the importance of uric acid in these diseases will be the conduct of large clinical trials in which the effect of lowering uric acid on hard clinical outcomes is assessed. Elevated uric acid may turn out to be one of the more important remediable risk factors for metabolic and cardiovascular diseases. PMID:26703429

Enhancing healthcare process design with human factors engineering and reliability science, part 2: applying the knowledge to clinical documentation systems.

PubMed

Boston-Fleischhauer, Carol

2008-02-01

The demand to redesign healthcare processes that achieve efficient, effective, and safe results is never-ending. Part 1 of this 2-part series introduced human factors engineering and reliability science as important knowledge to enhance existing operational and clinical process design methods in healthcare organizations. In part 2, the author applies this knowledge to one of the most common operational processes in healthcare: clinical documentation. Specific implementation strategies and anticipated results are discussed, along with organizational challenges and recommended executive responses.

Self-esteem: a closer look at clinical interventions.

PubMed

Meisenhelder, J B

1985-01-01

Self-esteem, a positive regard for oneself, is a universal need for every human being and a key component in restoring and maintaining mental and physical health. Yet, this important concept is remarkably neglected in nursing literature and easily overlooked in clinical practice. This article examines the existing research on the antecedents of self-esteem and compiles a list of factors which can facilitate the nurse's therapeutic effect on her client's positive self-concept. From this list, specific nursing interventions are provided for raising and maintaining a client's self-esteem. Since the impact of nursing interventions varies with clinical circumstances, the nursing actions are correlated with their most effective health care settings. This article provides a global and practical approach to the enhancement of clients' self-esteem.

Cryopreservation of Human Mesenchymal Stem Cells for Clinical Applications: Current Methods and Challenges.

PubMed

Yong, Kar Wey; Wan Safwani, Wan Kamarul Zaman; Xu, Feng; Wan Abas, Wan Abu Bakar; Choi, Jane Ru; Pingguan-Murphy, Belinda

2015-08-01

Mesenchymal stem cells (MSCs) hold many advantages over embryonic stem cells (ESCs) and other somatic cells in clinical applications. MSCs are multipotent cells with strong immunosuppressive properties. They can be harvested from various locations in the human body (e.g., bone marrow and adipose tissues). Cryopreservation represents an efficient method for the preservation and pooling of MSCs, to obtain the cell counts required for clinical applications, such as cell-based therapies and regenerative medicine. Upon cryopreservation, it is important to preserve MSCs functional properties including immunomodulatory properties and multilineage differentiation ability. Further, a biosafety evaluation of cryopreserved MSCs is essential prior to their clinical applications. However, the existing cryopreservation methods for MSCs are associated with notable limitations, leading to a need for new or improved methods to be established for a more efficient application of cryopreserved MSCs in stem cell-based therapies. We review the important parameters for cryopreservation of MSCs and the existing cryopreservation methods for MSCs. Further, we also discuss the challenges to be addressed in order to preserve MSCs effectively for clinical applications.

Coping with Memory Effect and Serial Correlation when Estimating Reliability in a Longitudinal Framework

ERIC Educational Resources Information Center

Laenen, Annouschka; Alonso, Ariel; Molenberghs, Geert; Vangeneugden, Tony; Mallinckrodt, Craig H.

2010-01-01

Longitudinal studies are permeating clinical trials in psychiatry. Therefore, it is of utmost importance to study the psychometric properties of rating scales, frequently used in these trials, within a longitudinal framework. However, intrasubject serial correlation and memory effects are problematic issues often encountered in longitudinal data.…

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

PubMed Central

2014-01-01

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

Text Mining for Precision Medicine: Bringing structure to EHRs and biomedical literature to understand genes and health

PubMed Central

Simmons, Michael; Singhal, Ayush; Lu, Zhiyong

2018-01-01

The key question of precision medicine is whether it is possible to find clinically actionable granularity in diagnosing disease and classifying patient risk. The advent of next generation sequencing and the widespread adoption of electronic health records (EHRs) have provided clinicians and researchers a wealth of data and made possible the precise characterization of individual patient genotypes and phenotypes. Unstructured text — found in biomedical publications and clinical notes — is an important component of genotype and phenotype knowledge. Publications in the biomedical literature provide essential information for interpreting genetic data. Likewise, clinical notes contain the richest source of phenotype information in EHRs. Text mining can render these texts computationally accessible and support information extraction and hypothesis generation. This chapter reviews the mechanics of text mining in precision medicine and discusses several specific use cases, including database curation for personalized cancer medicine, patient outcome prediction from EHR-derived cohorts, and pharmacogenomic research. Taken as a whole, these use cases demonstrate how text mining enables effective utilization of existing knowledge sources and thus promotes increased value for patients and healthcare systems. Text mining is an indispensable tool for translating genotype-phenotype data into effective clinical care that will undoubtedly play an important role in the eventual realization of precision medicine. PMID:27807747

Text Mining for Precision Medicine: Bringing Structure to EHRs and Biomedical Literature to Understand Genes and Health.

PubMed

Simmons, Michael; Singhal, Ayush; Lu, Zhiyong

2016-01-01

The key question of precision medicine is whether it is possible to find clinically actionable granularity in diagnosing disease and classifying patient risk. The advent of next-generation sequencing and the widespread adoption of electronic health records (EHRs) have provided clinicians and researchers a wealth of data and made possible the precise characterization of individual patient genotypes and phenotypes. Unstructured text-found in biomedical publications and clinical notes-is an important component of genotype and phenotype knowledge. Publications in the biomedical literature provide essential information for interpreting genetic data. Likewise, clinical notes contain the richest source of phenotype information in EHRs. Text mining can render these texts computationally accessible and support information extraction and hypothesis generation. This chapter reviews the mechanics of text mining in precision medicine and discusses several specific use cases, including database curation for personalized cancer medicine, patient outcome prediction from EHR-derived cohorts, and pharmacogenomic research. Taken as a whole, these use cases demonstrate how text mining enables effective utilization of existing knowledge sources and thus promotes increased value for patients and healthcare systems. Text mining is an indispensable tool for translating genotype-phenotype data into effective clinical care that will undoubtedly play an important role in the eventual realization of precision medicine.

Factors Influencing Clinical Correlates of Chronic Traumatic Encephalopathy (CTE): A Review

PubMed Central

Asken, Breton M.; Sullan, Molly J.; Snyder, Aliyah R.; Houck, Zachary M.; Bryant, Vaughn E.; Hizel, Loren P.; McLaren, Molly E.; Dede, Duane E.; Jaffee, Michael S.; DeKosky, Steven T.; Bauer, Russell M.

2017-01-01

Chronic traumatic encephalopathy (CTE) is a neuropathologically defined disease reportedly linked to a history of repetitive brain trauma. As such, retired collision sport athletes are likely at heightened risk for developing CTE. Researchers have described distinct pathological features of CTE as well a wide range of clinical symptom presentations, recently termed traumatic encephalopathy syndrome (TES). These clinical symptoms are highly variable, non-specific to individuals described as having CTE pathology in case reports, and are often associated with many other factors. This review describes the cognitive, emotional, and behavioral changes associated with 1) developmental and demographic factors, 2) neurodevelopmental disorders, 3) normal aging, 4) adjusting to retirement, 5) drug and alcohol abuse, 6) surgeries and anesthesia, and 7) sleep difficulties, as well as the relationship between these factors and risk for developing dementia-related neurodegenerative disease. We discuss why some professional athletes may be particularly susceptible to many of these effects and the importance of choosing appropriate controls groups when designing research protocols. We conclude that these factors should be considered as modifiers predominantly of the clinical outcomes associated with repetitive brain trauma within a broader biopsychosocial framework when interpreting and attributing symptom development, though also note potential effects on neuropathological outcomes. Importantly, this could have significant treatment implications for improving quality of life. PMID:27561662

Effects of a Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients With Cancer Regarding Clinical Trial Participation: A Multicenter Randomized Controlled Trial

PubMed Central

Jacobsen, Paul B.; Wells, Kristen J.; Meade, Cathy D.; Quinn, Gwendolyn P.; Lee, Ji-Hyun; Fulp, William J.; Gray, Jhanelle E.; Baz, Rachid C.; Springett, Gregory M.; Levine, Richard M.; Markham, Merry-Jennifer; Schreiber, Fred J.; Cartwright, Thomas H.; Burke, James M.; Siegel, Robert D.; Malafa, Mokenge P.; Sullivan, Daniel

2012-01-01

Purpose The negative attitudes of patients with cancer regarding clinical trials are an important contributor to low participation rates. This study evaluated whether a brief psychoeducational intervention was effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials. Patients and Methods A total of 472 adults with cancer who had not been asked previously to participate in a clinical trial were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials. The primary (attitudes) and secondary outcomes (knowledge, self-efficacy, receptivity, and willingness) were assessed via patient self-report before random assignment and 7 to 28 days later. Results Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials (P = .016) and greater willingness to participate (P = .011) at follow-up than patients who received printed educational information. Evidence of an indirect effect of intervention assignment on willingness to participate (estimated at 0.168; 95% CI, 0.088 to 0.248) suggested that the benefits of psychoeducation on willingness to participate were explained by the positive impact of psychoeducation on attitudes toward clinical trials. Conclusion A brief psychoeducational intervention can improve the attitudes of patients with cancer toward clinical trials and thereby increase their willingness to participate in clinical trials. Findings support conducting additional research to evaluate effects of this intervention on quality of decision making and rates of participation among patients asked to enroll onto therapeutic clinical trials. PMID:22614993

Possible benefits of strontium ranelate in complicated long bone fractures.

PubMed

Alegre, Duarte Nuno; Ribeiro, Costa; Sousa, Carlos; Correia, João; Silva, Luís; de Almeida, Luís

2012-02-01

Osteoporosis drugs are prescribed to prevent fragility fractures, which is the principal aim of the management of osteoporosis. However, if fracture does occur, then it is also important to promote a fast and uneventful healing process. Despite this, little is known about the effect of osteoporosis drugs on bone healing in humans. Strontium ranelate is an osteoporosis agent that increases bone formation and reduces bone resorption and may therefore be beneficial in fracture healing. We report four cases of fracture non-union for up to 20 months. Treatment with strontium ranelate (2 g/day) for between 6 weeks and 6 months appeared to contribute to bone consolidation in the four cases. Animal studies support beneficial effects of strontium ranelate on bone healing via improvement of bone material properties and microarchitecture in the vicinity of the fracture. The clinical cases described herein provide new information on these effects, in the absence of randomized controlled studies on the clinical efficacy of pharmacological treatments in osteoporosis in fracture repair. Further studies are necessary. Fracture healing is an important topic in orthopedic research and is also a concern for patients with postmenopausal osteoporosis. Evidence from case reports and animal studies suggests that strontium ranelate improves bone microarchitecture and accelerates fracture healing. A positive effect of osteoporosis treatments on bone healing is an interesting possibility and merits further clinical research.

The Lived Experience and Training Needs of Librarians Serving at the Clinical Point-of-Care

PubMed Central

Kuntz, Gretchen M.; Edwards, Mary E.; Butson, Linda C.; Auten, Beth

2016-01-01

This study examines the emotional experiences and perceptions of librarians embedded into clinical care teams and how those perceptions affect their training and preparation needs. Qualitative research methodologies were applied to textual data drawn from focus groups (n=21), interviews (n=2), and an online survey (n=167), supplemented by quantitative survey data. Phenomenological results show librarians experience strongly effective responses to clinical rounding. Important factors include personal confidence; relationships with team members, patients, and families; and the stressful environment. Analysis of librarians’ perceived educational needs indicates that training must address specialized subjects including medical knowledge, clinical culture, and institutional politics. PMID:26211792

Experimental and clinical psychopharmacology: National Institute on Drug Abuse's clinical research agenda.

PubMed

Leshner, Alan I

2002-08-01

Studies of drugs and behavior are a core component of virtually every portfolio within the broad purview of the National Institute on Drug Abuse (NIDA). Moreover, psychopharmacological research is an important vehicle for advancing understanding of how drugs of abuse produce their effects, particularly including addiction. However, as with all major public health issues, simply understanding the issue is not enough. NIDA's psychopharmacology projects, therefore, span basic, clinical, and applied (e.g., medication development) research activities. These include the establishment of a nationwide clinical trials network designed to provide an infrastructure to test both behavioral and psychopharmacological treatments in a real-life practice setting with diverse patients.

Correlations of fatty acid supplementation, aeroallergens, shampoo, and ear cleanser with multiple parameters in pruritic dogs.

PubMed

Nesbitt, Gene H; Freeman, Lisa M; Hannah, Steven S

2004-01-01

Seventy-two pruritic dogs were fed one of four diets controlled for n-6:n-3 fatty acid ratios and total dietary intake of fatty acids. Multiple parameters were evaluated, including clinical and cytological findings, aeroallergen testing, microbial sampling techniques, and effects of an anti-fungal/antibacterial shampoo and ear cleanser. Significant correlations were observed between many clinical parameters, anatomical sampling sites, and microbial counts when data from the diet groups was combined. There were no statistically significant differences between individual diets for any of the clinical parameters. The importance of total clinical management in the control of pruritus was demonstrated.

Clinical aspects of autoimmune rheumatic diseases.

PubMed

Goldblatt, Fiona; O'Neill, Sean G

2013-08-31

Multisystem autoimmune rheumatic diseases are heterogeneous rare disorders associated with substantial morbidity and mortality. Efforts to create international consensus within the past decade have resulted in the publication of new classification or nomenclature criteria for several autoimmune rheumatic diseases, specifically for systemic lupus erythematosus, Sjögren's syndrome, and the systemic vasculitides. Substantial progress has been made in the formulation of new criteria in systemic sclerosis and idiopathic inflammatory myositis. Although the autoimmune rheumatic diseases share many common features and clinical presentations, differentiation between the diseases is crucial because of important distinctions in clinical course, appropriate drugs, and prognoses. We review some of the dilemmas in the diagnosis of these autoimmune rheumatic diseases, and focus on the importance of new classification criteria, clinical assessment, and interpretation of autoimmune serology. In this era of improvement of mortality rates for patients with autoimmune rheumatic diseases, we pay particular attention to the effect of leading complications, specifically cardiovascular manifestations and cancer, and we update epidemiology and prognosis. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical nursing informatics. Developing tools for knowledge workers.

PubMed

Ozbolt, J G; Graves, J R

1993-06-01

Current research in clinical nursing informatics is proceeding along three important dimensions: (1) identifying and defining nursing's language and structuring its data; (2) understanding clinical judgment and how computer-based systems can facilitate and not replace it; and (3) discovering how well-designed systems can transform nursing practice. A number of efforts are underway to find and use language that accurately represents nursing and that can be incorporated into computer-based information systems. These efforts add to understanding nursing problems, interventions, and outcomes, and provide the elements for databases from which nursing's costs and effectiveness can be studied. Research on clinical judgment focuses on how nurses (perhaps with different levels of expertise) assess patient needs, set goals, and plan and deliver care, as well as how computer-based systems can be developed to aid these cognitive processes. Finally, investigators are studying not only how computers can help nurses with the mechanics and logistics of processing information but also and more importantly how access to informatics tools changes nursing care.

Raising Public Awareness of Clinical Trials: Development of Messages for a National Health Communication Campaign.

PubMed

Massett, Holly A; Dilts, David M; Bailey, Robert; Berktold, Jennifer; Ledsky, Rebecca; Atkinson, Nancy L; Mishkin, Grace; Denicoff, Andrea; Padberg, Rose Mary; Allen, Marin P; Silver, Karen; Carrington, Kelli; Johnson, Lenora E

2017-05-01

Clinical trials are essential for developing new and effective treatments and improving patient quality of life; however, many trials cannot answer their primary research questions because they fall short of their recruitment goals. This article reports the results of formative research conducted in two populations, the public and primary care physicians, to identify messages that may raise awareness and increase interest in clinical trials and be used in a national communication campaign. Results suggested that participants were primarily motivated to participate in clinical trials out of a self-interest to help themselves first. Messages illustrated that current treatments were tested via clinical trials, helped normalize trials as routine practices, and reduced concerns over trying something new first. Participants wanted messages that portray trials as state-of-the-art choices that offer some hope, show people like themselves, and are described in a clear, concise manner with actionable steps for them to take. The study revealed some differences in message salience, with healthy audiences exhibiting lower levels of interest. Our results suggest that targeted messages are needed, and that communication with primary health-care providers is an important and necessary component in raising patient awareness of the importance of clinical trials.

Identifying the domains of context important to implementation science: a study protocol.

PubMed

Squires, Janet E; Graham, Ian D; Hutchinson, Alison M; Michie, Susan; Francis, Jill J; Sales, Anne; Brehaut, Jamie; Curran, Janet; Ivers, Noah; Lavis, John; Linklater, Stefanie; Fenton, Shannon; Noseworthy, Thomas; Vine, Jocelyn; Grimshaw, Jeremy M

2015-09-28

There is growing recognition that "context" can and does modify the effects of implementation interventions aimed at increasing healthcare professionals' use of research evidence in clinical practice. However, conceptual clarity about what exactly comprises "context" is lacking. The purpose of this research program is to develop, refine, and validate a framework that identifies the key domains of context (and their features) that can facilitate or hinder (1) healthcare professionals' use of evidence in clinical practice and (2) the effectiveness of implementation interventions. A multi-phased investigation of context using mixed methods will be conducted. The first phase is a concept analysis of context using the Walker and Avant method to distinguish between the defining and irrelevant attributes of context. This phase will result in a preliminary framework for context that identifies its important domains and their features according to the published literature. The second phase is a secondary analysis of qualitative data from 13 studies of interviews with 312 healthcare professionals on the perceived barriers and enablers to their application of research evidence in clinical practice. These data will be analyzed inductively using constant comparative analysis. For the third phase, we will conduct semi-structured interviews with key health system stakeholders and change agents to elicit their knowledge and beliefs about the contextual features that influence the effectiveness of implementation interventions and healthcare professionals' use of evidence in clinical practice. Results from all three phases will be synthesized using a triangulation protocol to refine the context framework drawn from the concept analysis. The framework will then be assessed for content validity using an iterative Delphi approach with international experts (researchers and health system stakeholders/change agents). This research program will result in a framework that identifies the domains of context and their features that can facilitate or hinder: (1) healthcare professionals' use of evidence in clinical practice and (2) the effectiveness of implementation interventions. The framework will increase the conceptual clarity of the term "context" for advancing implementation science, improving healthcare professionals' use of evidence in clinical practice, and providing greater understanding of what interventions are likely to be effective in which contexts.

Understanding the 'Silver Book' - An important reference for standardised nomenclature in clinical laboratory sciences.

PubMed

Flatman, Robert; Férard, Georges; Dybkaer, René

2017-04-01

Clinical laboratories perform a wide menu of testing (examinations). Successful requesting, examination, and ordering in this environment requires clear standardised nomenclature. The Silver Book (SB) is an IUPAC (International Union of Pure and Applied Chemistry) publication, produced with the support of both IUPAC and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine), that makes recommendations on logical standardised nomenclature, symbols, properties, and units in many disciplines of the clinical laboratory sciences. These recommendations are founded on and in agreement with the principles and work of the International Organization for Standardization (ISO), Bureau International des Poids et Mesures (BIPM), IUPAC, and the IFCC. Practical applications described are based on those scientific principles. The SB recommendations apply to all types of examination, not only to measurement of quantities but also examination of nominal properties where no magnitude is involved. The SB is applicable not only to clinical chemistry, but to many other clinical laboratory disciplines. For examples, reports regarding haemostasis, toxicology, clinical microbiology, reproduction and fertility, clinical pharmacology, clinical allergology, clinical molecular biology, and clinical immunohaematology have been published by the IUPAC and the IFCC. Peak scientific bodies such as the IUPAC and the IFCC have important roles in the development of sound international standards for nomenclature of examinations. Such standards support safe and effective representation of patient health information, foster portability, and empower future decision support systems. Copyright © 2016. Published by Elsevier B.V.

Clinical significance in nursing research: A discussion and descriptive analysis.

PubMed

Polit, Denise F

2017-08-01

It is widely understood that statistical significance should not be equated with clinical significance, but the topic of clinical significance has not received much attention in the nursing literature. By contrast, interest in conceptualizing and operationalizing clinical significance has been a "hot topic" in other health care fields for several decades. The major purpose of this paper is to briefly describe recent advances in defining and quantifying clinical significance. The overview covers both group-level indicators of clinical significance (e.g., effect size indexes), and individual-level benchmarks (e.g., the minimal important change index). A secondary purpose is to describe the extent to which developments in clinical significance have penetrated the nursing literature. A descriptive analysis of a sample of primary research articles published in three high-impact nursing research journals in 2016 was undertaken. A total of 362 articles were electronically searched for terms relating to statistical and clinical significance. Of the 362 articles, 261 were reports of quantitative studies, the vast majority of which (93%) included a formal evaluation of the statistical significance of the results. By contrast, the term "clinical significance" or related surrogate terms were found in only 33 papers, and most often the term was used informally, without explicit definition or assessment. Raising consciousness about clinical significance should be an important priority among nurse researchers. Several recommendations are offered to improve the visibility and salience of clinical significance in nursing science. Copyright © 2017 Elsevier Ltd. All rights reserved.

The relaxant effect of Nigella sativa on smooth muscles, its possible mechanisms and clinical applications

PubMed Central

Keyhanmanesh, Rana; Gholamnezhad, Zahra; Boskabady, Mohammad Hossien

2014-01-01

Nigella sativa (N. sativa) is a spice plant which has been traditionally used for culinary and medicinal purposes. Different therapeutic properties including the beneficial effects on asthma and dyspnea, digestive and gynecology disorders have been described for the seeds of N. sativa. There is evidence of the relaxant effects of this plant and some of its constituents on different types of smooth muscle including rabbit aorta, rabbit jejunum and trachea. The relaxant effect of N. sativa could be of therapeutic importance such as bronchodilation in asthma, vasodilation in hypertension and therapeutic effect on digestive or urogenital disorders. Therefore in the present article, the relaxant effects of N. sativa and its constituents on smooth muscles and its possible mechanisms as well as clinical application of this effect were reviewed. PMID:25859297

Gut microbiota and probiotics: Focus on diabetes mellitus.

PubMed

Bordalo Tonucci, Livia; Dos Santos, Karina Maria Olbrich; De Luces Fortes Ferreira, Celia Lucia; Ribeiro, Sonia Machado Rocha; De Oliveira, Leandro Licursi; Martino, Hercia Stampini Duarte

2017-07-24

The characterization of gut microbiota has become an important area of research in several clinical conditions, including type 2 diabetes (T2DM). Changes in the composition and/or metabolic activity of the gut microbiota can contribute to human health. Thus, this review discusses the effects of probiotics and gut microbiota on metabolic control in these individuals. Relevant studies were obtained from electronic databases such as PubMed/Medline and ISI Web of Science. The main probiotics used in these studies belonged to the genera Lactobacillus and Bifidobacterium. The authors found seven randomized placebo-controlled clinical trials and 13 experimental studies directly related to the effect of probiotics on metabolic control in the context of T2DM. The hypothesis that gut microbiota plays a role in the development of diabetes indicates an important beginning, and the potential of probiotics to prevent and reduce the severity of T2DM is better observed in animal studies. In clinical trials, the use of probiotics in glycemic control presented conflicting results, and only few studies have attempted to evaluate factors that justify metabolic changes, such as markers of oxidative stress, inflammation, and incretins. Thus, further research is needed to assess the effects of probiotics in the metabolism of diabetic individuals, as well as the main mechanisms involved in this complex relationship.

Nonlinear dynamics of the patient’s response to drug effect during general anesthesia

NASA Astrophysics Data System (ADS)

Ionescu, Clara; Tenreiro Machado, Jose; De Keyser, Robin; Decruyenaere, Johan; Struys, Michel M. R. F.

2015-03-01

In today's healthcare paradigm, optimal sedation during anesthesia plays an important role both in patient welfare and in the socio-economic context. For the closed-loop control of general anesthesia, two drugs have proven to have stable, rapid onset times: propofol and remifentanil. These drugs are related to their effect in the bispectral index, a measure of EEG signal. In this paper wavelet time-frequency analysis is used to extract useful information from the clinical signals, since they are time-varying and mark important changes in patient's response to drug dose. Model based predictive control algorithms are employed to regulate the depth of sedation by manipulating these two drugs. The results of identification from real data and the simulation of the closed loop control performance suggest that the proposed approach can bring an improvement of 9% in overall robustness and may be suitable for clinical practice.

Vitamin E in the prevention of cardiovascular disease: the importance of proper patient selection

PubMed Central

Vardi, Moshe; Levy, Nina S.; Levy, Andrew P.

2013-01-01

Vitamin E is a naturally occurring fat-soluble antioxidant which has been proposed as a treatment for both primary and secondary protection against cardiovascular (CV) events. Promising data from observational epidemiological studies associating higher vitamin E dietary intake with lower risk of CV events have not been validated in randomized controlled clinical trials assessing the effect of vitamin E on CV outcomes. While the pendulum of medical opinion has swung to suggest that high dose vitamin E supplements have no place in the treatment and prevention of CV disease, new data is emerging that allows identification of a specific target population for this treatment, namely patients with diabetes mellitus and the haptoglobin genotype 2-2. This review details the scientific basis and clinical evidence related to the effect of vitamin E on CV outcomes, and the importance of proper patient selection in gaining therapeutic benefit from this intervention. PMID:23505320

Androgens: basic biology and clinical implication.

PubMed

Orwoll, E S

2001-10-01

Although androgens have been considered essential modulators of bone biology in men, recent studies have indicated that estrogen may have an important, if not dominant, role. Nevertheless, there is strong evidence that androgens have independent skeletal actions. Nonaromatizable androgens influence a variety of aspects of bone cell biology and are capable of modulating bone remodeling and bone mass. It appears that androgens are particularly important in the control of periosteal bone formation, an effect that might underlie the gender difference in bone size. Alterations in androgen receptor function affect bone metabolism, and new information suggests that androgens modulate receptor homeostasis. The clinical implications of androgen effects, and how they interact with those of estrogens, are somewhat unclear. It is likely that overall bone homeostasis and gender differences depend on a combination of androgenic and estrogenic actions. Androgens may well provide advantages in the prevention and therapy of metabolic bone disorders in both men and women.

The relationship between agreeableness and the development of the working alliance in patients with borderline personality disorder.

PubMed

Hirsh, Jacob B; Quilty, Lena C; Bagby, R Michael; McMain, Shelley F

2012-08-01

The working alliance between therapist and patient is an important component of effective interventions for borderline personality disorder (BPD). The current study examines whether client personality affects the development of the working alliance during the treatment of BPD, and whether this influences treatment effectiveness. Data was based on 87 patients with BPD who were participants in a randomized controlled trial comparing Dialectical Behavior Therapy (DBT) and general psychiatric management. Higher levels of trait Agreeableness were associated with steeper increases in working alliance throughout treatment, but only in the DBT condition. Increases in working alliance were in turn associated with better clinical outcomes. Mediation models revealed a significant indirect path from Agreeableness to better clinical outcomes, mediated through larger improvements in working alliance over time. These results highlight the role that patient personality can play during the therapeutic process, with a specific focus on the importance of Agreeableness for alliance development.

Mediating role of critical thinking disposition in the relationship between perceived barriers to research use and evidence-based practice.

PubMed

Kim, Sun-Ae; Song, Youngshin; Sim, Hee-Sook; Ahn, Eun-Kyong; Kim, Jung-Hee

2015-01-01

Despite the importance of critical thinking in clinical and educational settings, little is known about its role in evidence-based practice (EBP). This study examined whether critical thinking disposition (CTD) mediates the relationship between perceived barriers to research use and EBP in clinical nurses (N=409). A path diagram using structural equation modeling was used to estimate the direct and indirect effects of perceived barriers to research use on EBP, controlling for CTD as a mediator. CTD partially mediated the relationship between perceived barriers to research use and EBP. Furthermore, the hypothesized mediation model demonstrated an appropriate fit to the data. Individual and organizational efforts are needed to help nurses further improve their critical thinking skills. CTD is important as research barriers to engage effectively in EBP. Without the skills to evaluate evidence carefully, research utilization may be compromised.

Religion, health and medicine in African Americans: implications for physicians.

PubMed

Levin, Jeff; Chatters, Linda M; Taylor, Robert Joseph

2005-02-01

Recent years have seen a burgeoning of research and writing on the connections between religion and health. The very best of this work comes from epidemiologic studies of African Americans. This paper summarizes results of these investigations, including findings identifying effects of religious participation on both physical and mental health outcomes. Evidence mostly supports a protective religious effect on morbidity and mortality and on depressive symptoms and overall psychological distress among African Americans. This paper also carefully discusses what the results of these studies mean and do not mean, an important consideration due to frequent misinterpretations of findings on this topic. Because important distinctions between epidemiologic and clinical studies tend to get glossed over, reports of religion-health associations oftentimes draw erroneous conclusions that foster unrealistic expectations about the role of faith and spirituality in health and healing. Finally, implications are discussed for clinical practice, medical education and public health.

The Importance of First Impressions: Early Events in Mycobacterium tuberculosis Infection Influence Outcome.

PubMed

Cadena, Anthony M; Flynn, JoAnne L; Fortune, Sarah M

2016-04-05

Tuberculosis remains a major health threat in much of the world. New vaccines against Mycobacterium tuberculosis are essential for preventing infection, disease, and transmission. However, the host immune responses that need to be induced by an effective vaccine remain unclear. Increasingly, it has become clear that early events in infection are of major importance in the eventual outcome of the infection. Studying such events in humans is challenging, as they occur within the lung and thoracic lymph nodes, and any clinical signs of early infection are relatively nonspecific. Nonetheless, clinical studies and animal models of tuberculosis have provided new insights into the local events that occur in the first few weeks of tuberculosis. Development of an effective vaccine requires a clear understanding of the successful (and detrimental) early host responses against M. tuberculosis, with the goal to improve upon natural immune responses and prevent infection or disease. Copyright © 2016 Cadena et al.

Religion, health and medicine in African Americans: implications for physicians.

PubMed Central

Levin, Jeff; Chatters, Linda M.; Taylor, Robert Joseph

2005-01-01

Recent years have seen a burgeoning of research and writing on the connections between religion and health. The very best of this work comes from epidemiologic studies of African Americans. This paper summarizes results of these investigations, including findings identifying effects of religious participation on both physical and mental health outcomes. Evidence mostly supports a protective religious effect on morbidity and mortality and on depressive symptoms and overall psychological distress among African Americans. This paper also carefully discusses what the results of these studies mean and do not mean, an important consideration due to frequent misinterpretations of findings on this topic. Because important distinctions between epidemiologic and clinical studies tend to get glossed over, reports of religion-health associations oftentimes draw erroneous conclusions that foster unrealistic expectations about the role of faith and spirituality in health and healing. Finally, implications are discussed for clinical practice, medical education and public health. PMID:15712787

Long-Term Acupuncture Therapy for Low-Income Older Adults with Multimorbidity: A Qualitative Study of Patient Perceptions.

PubMed

Pagones, Rachel; Lee, Janet L; Hurst, Samantha

2018-02-01

Multimorbidity is common, but often poorly managed, among the rapidly growing population of older adults. The existing guidelines followed by physicians frequently lead to polypharmacy and a complex treatment burden. The objective of this study was to explore what benefits are perceived by older adults with multimorbidity as a result of long-term, regular acupuncture treatment. A qualitative design with inductive thematic analysis of semistructured interviews. Participants were recruited from a no-cost, college-affiliated acupuncture clinic for low-income older adults in an urban, racially/ethnically diverse neighborhood in southern California. Fifteen patients aged 60 years and older suffering from at least two chronic conditions. Five themes were identified: (1) mind-body effects, (2) the enhanced therapeutic alliance, (3) what they liked best, (4) the conventional healthcare system, and (5) importance of regular schedule. A notable mind-body effect, reported by a substantial number of participants, was medication reduction. Participants also cited changes in mood, energy, and well-being as important benefits. In addition, they voiced widespread dissatisfaction with conventional healthcare. Keeping up regular treatments as a way to deal with new complaints and encourage a healthier lifestyle was seen an important aspect of care at the clinic. This cohort of older adults with multimorbidity valued acupuncture as a way to reduce medication as well as a means to maintain physical and mental health. In addition, they developed a strong trust in the clinic's ability to support the totality of their health as individuals, which they contrasted to the specialized and impersonal approach of the conventional medical clinic.

The changing training needs of clinical nurse managers: exploring issues for continuing professional development.

PubMed

Gould, D; Kelly, D; Goldstone, L; Maidwell, A

2001-04-01

To identify areas where clinical nurse managers perceived that they would benefit from further training and to make recommendations for planning future programmes to meet their needs. The effectiveness of the clinical nurse manager has traditionally been associated with maintaining standards of care. Continuing professional development (CPD) is essential to ensure this important group feel adequately prepared to perform their role and has been recognized as an important factor in maintaining job satisfaction and reducing wasteful staff turnover. A review of the literature indicated that since the 1980s the CPD needs of clinical nurse managers have tended to be overlooked despite increasing complexity of the tasks expected of them. Thus it appeared that a fresh study to address these needs would be justified and should take into account sources of work-related stress and variables relating to job satisfaction. The study involved clinical nurse managers employed in all four acute hospital National Health Service (NHS) trusts where training needs were served by a major inner city educational consortium. Data collection proceeded in two stages. Initially interviews were undertaken with a random sample of 15 clinical nurse managers to provide in-depth, qualitative data. This information was used to develop a survey questionnaire distributed to the remaining 182 clinical nurse managers in each of the trusts. Data from the interviews indicated that clinical nurse managers appeared to feel clinically competent but generally experienced lack of confidence when dealing with a range of issues, in particular; human resources, managing budgets, deputizing for senior colleagues across the trust ('acting up') and using information technology in everyday practice. Response rate to the survey was good (65%). The results corroborated the interview findings, indicating a need for updating in the same wide range of topics. There were few differences in training needs across all four trusts. Clinical nurse managers who perceived that they had been well-prepared for their role demonstrated higher levels of job satisfaction. Perceived preparation for clinical leadership was the same irrespective of the employing trust, length of time in post and other sociodemographic variables. The study findings confirm that CPD remains a major issue for clinical nurse managers in the United Kingdom (UK) and that providing opportunities for such development may be an important factor in enhancing job satisfaction. The study findings should help those providing CPD to plan more effectively for this group and have implications for staff recruitment and retention.

AHRQ series paper 2: principles for developing guidance: AHRQ and the effective health-care program.

PubMed

Helfand, Mark; Balshem, Howard

2010-05-01

This article describes some of the fundamental principles that have been developed to guide the work of producing comparative effectiveness reviews (CERs). We briefly describe the role stakeholders play in providing important insights that inform the evidence-gathering process, and discuss the critical role of analytic frameworks in illuminating the relationship between surrogate measures and health outcomes, providing an understanding of the context in which clinical decisions are made and the uncertainties that underlie clinical controversies. We describe the Effective Health Care program conceptual model for considering different types of evidence that emphasizes minimizing the risk of bias, but places high-quality, highly applicable evidence about effectiveness at the top of the hierarchy. Finally, we briefly describe areas of future methodological research. CERs have become a foundation for decision-making in clinical practice and health policy. To be useful, CERs must approach the evidence from a patient-centered perspective; explore the clinical logic underlying the rationale for a service; cast a broad net with respect to types of evidence, placing a high value on effectiveness and applicability, in addition to internal validity; and, present benefits and harms for treatments and tests in a consistent way.

FDA: Evidentiary Standards for Drug Development and Approval

PubMed Central

Katz, Russell

2004-01-01

Summary: The United States Food and Drug Administration is charged with approving drug treatments that have been shown to be safe and effective. Relevant statutes and regulations provide a legal framework for establishing safety and effectiveness that is sufficiently flexible to ensure that appropriate scientific data are collected for specific treatments targeted to particular diseases. Nonetheless, all clinical trials proposed to establish effectiveness must incorporate common elements in order for the appropriate legal and scientific standards of drug approval to be met. This article will discuss the relevant laws and regulations pertaining to the current effectiveness standard and will discuss the most important clinical trial design elements currently considered acceptable for applications for treatments of neurologic and psychiatric illness. PMID:15717032

How I do it: Awake craniotomy.

PubMed

Hill, Ciaran Scott; Severgnini, Flavio; McKintosh, Edward

2017-01-01

Awake craniotomy allows continuous assessment of a patient's clinical and neurological status during open brain surgery. This facilitates early detection of interference with eloquent cortex, and hence can allow a surgeon to maximize resection margins without compromising neurological function. Awake craniotomy requires an effective scalp blockade, intraoperative assessment, and a carefully co-ordinated theatre team. A variety of clinical and electrophysiological techniques can be used to assess cortical function. Effective scalp blockade and awake craniotomy provides the opportunity to intraoperatively assess cortical function in the awake patient, thus providing an important neurosurgical option for lesions near eloquent cortex.

Nursing knowledge: hints from the placebo effect.

PubMed

Zanotti, Renzo; Chiffi, Daniele

2017-07-01

Nursing knowledge stems from a dynamic interplay between population-based scientific knowledge (the general) and specific clinical cases (the particular). We compared the 'cascade model of knowledge translation', also known as 'classical biomedical model' in clinical practice (in which knowledge gained at population level may be applied directly to a specific clinical context), with an emergentist model of knowledge translation. The structure and dynamics of nursing knowledge are outlined, adopting the distinction between epistemic and non-epistemic values. Then, a (moderately) emergentist approach to nursing knowledge is proposed, based on the assumption of a two-way flow from the general to the particular and vice versa. The case of the 'placebo effect' is analysed as an example of emergentist knowledge. The placebo effect is usually considered difficult to be explained within the classical biomedical model, and we underscore its importance in shaping nursing knowledge. In fact, nurses are primarily responsible for administering placebo in the clinical setting and have an essential role in promoting the placebo effect and reducing the nocebo effect. The beliefs responsible for the placebo effect are as follows: (1) interactive, because they depend on the relationship between patients and health care professionals; (2) situated, because they occur in a given clinical context related to certain rituals; and (3) grounded on higher order beliefs concerning what an individual thinks about the beliefs of others. It is essential to know the clinical context and to understand other people's beliefs to make sense of the placebo effect. The placebo effect only works when the (higher order) beliefs of doctors, nurses and patients interact in a given setting. Finally, we argue for a close relationship between placebo effect and nursing knowledge. © 2016 John Wiley & Sons Ltd.

Intercultural Usage of Mori Folium: Comparison Review from a Korean Medical Perspective

PubMed Central

Joh, Byungjin; Jeon, Eun Sang; Lim, Su Hye; Park, Yu Lee; Park, Wansu

2015-01-01

Objectives. A review on studies related to the use of Mori folium, the leaves of Morus alba, was conducted with the goal of identifying new clinical applications in Korean medicine. Methods. Global literature search was conducted using three electronic databases up to January 2015 with the term Morus alba and its Korean terms. KM literatures including textbooks and standard pharmacopoeia were separately hand-searched and reviewed to provide comparison. Data were extracted according to predetermined criteria, and clinical uses were standardized with ICD-10 categories. Results. 159 potentially relevant studies were identified, and 18 articles including 12 ethnopharmacologic and 6 clinical studies were finally included in this analysis. Ethnopharmacologic studies from 8 countries provided 17 clinical uses. We found that five out of six clinical trials were related to diabetes and suggested a moderate short-term to mild long-term effect. And 43 Korean texts also provided 156 clinical uses in 35 categories including ocular and respiratory disorders. Discussion and Conclusions. Though majority of the clinical uses were also found in Korean medicine literature, treatment of infertility, jaundice, cognitive disorder, and hyperpigmentation was found to be effective and diabetes with Morus alba was recognized to have clinical importance. PMID:26539223

Spinal cord injury: promising interventions and realistic goals.

PubMed

McDonald, John W; Becker, Daniel

2003-10-01

Long regarded as impossible, spinal cord repair is approaching the realm of reality as efforts to bridge the gap between bench and bedside point to novel approaches to treatment. It is important to recognize that the research playing field is rapidly changing and that new mechanisms of resource development are required to effectively make the transition from basic science discoveries to effective clinical treatments. This article reviews recent laboratory studies and phase 1 clinical trials in neural and nonneural cell transplantation, stressing that the transition from basic science to clinical applications requires a parallel rather than serial approach, with continuous, two-way feedback to most efficiently translate basic science findings, through evaluation and optimization, to clinical treatments. An example of mobilizing endogenous stem cells for repair is reviewed, with emphasis on the rapid application of basic science to clinical therapy. Successful and efficient transition from basic science to clinical applications requires (1) a parallel rather than a serial approach; (2) development of centers that integrate three spheres of science, translational, transitional, and clinical trials; and (3) development of novel resources to fund the most critically limited step of transitional to clinical trials.

[The inpatient treatment of patients with anorexia nervosa in German clinics].

PubMed

Föcker, Manuel; Heidemann-Eggert, Elke; Antony, Gisela; Becker, Katja; Egberts, Karin; Ehrlich, Stefan; Fleischhaker, Christian; Hahn, Freia; Jaite, Charlotte; Kaess, Michael; M E Schulze, Ulrike; Sinzig, Judith; Wagner, Catharina; Legenbauer, Tanja; Renner, Tobias; Wessing, Ida; Herpertz-Dahlmann, Beate; Hebebrand, Johannes; Bühren, Katharina

2017-09-01

The medium- and long-term effects and side effects of inpatient treatment of patients with anorexia nervosa is still a matter of debate. The German S3-guidelines underline the importance of providing specialized and competent treatment. In this article we focus on the inpatient service structure in German child and adolescent psychiatric clinics with regard to their diagnostic and therapeutic concepts. A self-devised questionnaire was sent to 163 German child and adolescent psychiatric clinics. The questionnaire focused on the characteristics of the respective clinic as well as its diagnostic and therapeutic strategies. All clinics with an inpatient service for patients with anorexia nervosa (N = 84) provide single-therapy, family-based interventions and psychoeducation. A target weight is defined in nearly all clinics, and the mean intended weight gain per week is 486 g (range: 200 g to 700 g/week; SD = 117). Certain diagnostic tests and therapeutic interventions are used heterogeneously. This is the first study investigating the inpatient service structure for patients with anorexia nervosa in German clinics. Despite the provision of guideline-based therapy in all clinics, heterogeneous approaches were apparent with respect to specific diagnostic and therapeutic concepts.

Becoming a professional: What is the influence of registered nurses on nursing students' learning in the clinical environment?

PubMed

Ó Lúanaigh, Padraig

2015-11-01

This research was undertaken to understand the influence of registered nurses on nursing students' learning in the clinical environment to inform strategies to enable registered nurses to provide effective support to learners while also assisting nursing students to adopt approaches to maximise their learning in the clinical environment. A case study approach was applied in this research to explore descriptions of clinical experience of five final year nursing students. The student participants identified the importance of the clinical environment to their learning and wanted to and had actively managed their learning in the clinical environment. The students did not passively acquire knowledge or simply replicate what they observed from others. There was evidence that the students had strong and established perceptions of what constituted 'good' nursing and described an ability to discriminate between differing levels of nursing practice. Nursing knowledge was gained from respected registered nurses who were best able to describe and demonstrate the 'tricks of the trade' and 'little things that matter' when providing 'good' nursing. The outcomes from this research indicate an important role for registered nurses in both shaping nursing students' professional nursing identity and access to clinical learning. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evidence-based clinical practice, [corrected] evidence-based medicine and the Cochrane collaboration.

PubMed

Gambrill, E

1999-03-01

Encouraging professionals in training and later to consider practice-related research findings when making important clinical decisions is an on-going concern. Evidenced-Based Medicine (EBM) and the Cochrane Collaboration (CC) provide a source of tools and ideas for doing so, as well as a roster of colleagues who share this interest. Evidenced-based medicine involves integrating clinical expertise with the best available external evidence from systematic research as well as considering the values and expectations of patients/clients. Advantage can be taken of educational formats developed in EBM, such as problem-based learning and critical-appraisal workshops in which participants learn how to ask key answerable questions related to important clinical practice questions (e.g., regarding effectiveness, accuracy of assessment measures, prediction, prevention, and quality of clinical practice guidelines) and to access and critically appraise related research. The Cochrane Collaboration is a world-wide network of centers that prepare, maintain, and disseminate high-quality systematic reviews on the efficacy of healthcare. These databases allow access to evidence related to clinical practice decisions. Forging reciprocal working relationships with those involved in EBM reciprocal and the CC should contribute to the pursuit of shared goals such as basing clinical decisions on the best-available evidence and involving clients as informed consumers.

[Generalization of the results of clinical studies through the analysis of subgroups].

PubMed

Costa, João; Fareleira, Filipa; Ascensão, Raquel; Vaz Carneiro, António

2012-01-01

Subgroup analysis in clinical trials are usually performed to define the potential heterogeneity of treatment effect in relation with the baseline risk, physiopathology, practical application of therapy or the under-utilization in clinical practice of effective interventions due to uncertainties of its benefit/risk ratio. When appropriately planned, subgroup analysis are a valid methodology the define benefits in subgroups of patients, thus providing good quality evidence to support clinical decision making. However, in order to be correct, subgroup analysis should be defined a priori, done in small numbers, should be fully reported and, most important, must endure statistical tests for interaction. In this paper we present an example of the treatment of post-menopausal osteoporosis, in which the benefits of an intervention (the higher the fracture risk is, the better the benefit is) with a specific agent (bazedoxifene) was only disclosed after a post-hoc analysis of the initial global trial sample.

Clinical utility of measures of breathlessness.

PubMed

Cullen, Deborah L; Rodak, Bernadette

2002-09-01

The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea measurement instruments we studied meet important standards of validity and reliability. Discriminative measures have limited clinical utility and, when used for populations or conditions for which they are not designed or validated, the data collected may not be clinically relevant. Evaluative measures have greater clinical utility and can be applied for outcome purposes. Measures should be applied to the populations and conditions for which they were designed. The relationship between clinical therapies and the measurement of dyspnea as an outcome can develop as respiratory therapists become more comfortable with implementing dyspnea measurement instruments and use the data to improve patient treatment. Dyspnea evaluation should be considered for all clinical practice guidelines and care pathways.

[Implications in primary health care of medical genetics and genomic in type 2 diabetes mellitus].

PubMed

Ramirez-Garcia, Sergio Alberto; Cabrera-Pivaral, Carlos E; Huacuja-Ruiz, Luis; Flores-Alvarado, Luis Javier; Pérez-García, Guillermo; González-Rico, José Luis; López-Velázquez, Alma; Topete-González, Luz Rosalba; Rosales-Góme, Roberto Carlos; Candelario-Mejía, Gerardo; Villa-Ruano, Nemesio

2013-01-01

Type 2 diabetes mellitus is a complex disease and a global health problem. Therefore, the first level of health care should handle the approaches of medical genetics and genomics to reduce its incidence. The aim is to present perspectives analyzed by our group in two areas of genetics and its clinical application. Emphasis is placed on the coexistence of several genetic forms clinically detectable in patients with diabetes, missing heritability associated with low penetrance, and epigenomics mechanism. It is discussed the effect of genetic variation associated with resistance to insulin, beta-cell dysfunction, shaft incretin, and other points of interest, such as thrifty genotype hypothesis, conformational disease, genetically unknown foods, phenocopies as clinically silent hypercortisolism, molecular phytopharmacology in the clinical management. Finally, the result was displayed in the Mexican population from genetic studies and new findings of clinical importance, such as involvement of melatonin and effect of variations in the number of copies in a genomic region.

Effects of communication with important social referents on beliefs and intentions to use condoms.

PubMed

Strader, M K; Beaman, M L; McSweeney, M

1992-06-01

Data from a 1989 survey using the condom attitude and belief instrument with 310 clients from two sexually transmitted disease clinics identified significant social referents who influence condom-use intentions. They are sexual partner, father and friends. The present study found that communication with these referents had a positive net effect on beliefs about and intentions to use condoms. Implications applicable for intervention programmes to increase condom use are to promote talking about condoms between the sexual partners and important social referents and to develop such communication skills.

Allergic contact dermatitis to benzocaine: the importance of concomitant positive patch test results.

PubMed

González-Rodríguez, A J; Gutiérrez-Paredes, E M; Revert Fernández, Á; Jordá-Cuevas, E

2013-03-01

Local anesthetics are widely used in clinical practice, and adverse effects are not uncommon. Delayed hypersensitivity reactions are among the most common effects, but immediate-type reactions may also occur. Patch testing should be considered in patients with hypersensitivity reactions. We present a case of allergic contact dermatitis to benzocaine that was detected incidentally by patch testing and highlight the importance of correctly interpreting patch test results when there are concomitant positive reactions. Copyright © 2011 Elsevier España, S.L. and AEDV. All rights reserved.

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

PubMed Central

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

2014-01-01

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

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

PubMed

Bates, Katherine E; Vetter, Victoria L; Li, Jennifer S; Cummins, Susan; Aguel, Fernando; Almond, Christopher; Dubin, Anne M; Elia, Josephine; Finkle, John; Hausner, Elizabeth A; Joseph, Francesca; Karkowsky, Abraham M; Killeen, Matthew; Lemacks, Jodi; Mathis, Lisa; McMahon, Ann W; Pinnow, Ellen; Rodriguez, Ignacio; Stockbridge, Norman L; Stockwell, Margaret; Tassinari, Melissa; Krucoff, Mitchell W

2012-10-01

Development of pediatric medications and devices is complicated by differences in pediatric physiology and pathophysiology (both compared with adults and within the pediatric age range), small patient populations, and practical and ethical challenges to designing clinical trials. This article summarizes the discussions that occurred at a Cardiac Safety Research Consortium-sponsored Think Tank convened on December 10, 2010, where members from academia, industry, and regulatory agencies discussed important issues regarding pediatric cardiovascular safety of medications and cardiovascular devices. Pediatric drug and device development may use adult data but often requires additional preclinical and clinical testing to characterize effects on cardiac function and development. Challenges in preclinical trials include identifying appropriate animal models, clinically relevant efficacy end points, and methods to monitor cardiovascular safety. Pediatric clinical trials have different ethical concerns from adult trials, including consideration of the subjects' families. Clinical trial design in pediatrics should assess risks and benefits as well as incorporate input from families. Postmarketing surveillance, mandated by federal law, plays an important role in both drug and device safety assessment and becomes crucial in the pediatric population because of the limitations of premarketing pediatric studies. Solutions for this wide array of issues will require collaboration between academia, industry, and government as well as creativity in pediatric study design. Formation of various epidemiologic tools including registries to describe outcomes of pediatric cardiac disease and its treatment as well as cardiac effects of noncardiovascular medications, should inform preclinical and clinical development and improve benefit-risk assessments for the patients. The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive and provide suggestions for additional research to further our knowledge and understanding of this topic. Copyright © 2012 Mosby, Inc. All rights reserved.

Ingestion of Laundry Detergent Packets in Children.

PubMed

Shah, Lindsey Wilson

2016-08-01

Ingestion of laundry detergent packets is an important threat to young children. Because of their developmental stage, toddlers are prone to place these small, colorful packets in their mouths. The packets can easily burst, sending a large volume of viscous, alkaline liquid throughout the oropharynx. Ingestion causes major toxic effects, including depression of the central nervous system, metabolic acidosis, respiratory distress, and dysphagia. Critical care nurses should anticipate these clinical effects and facilitate prompt intervention. Increased understanding of the risks and clinical effects of ingestion of laundry detergent packets will better prepare critical care nurses to provide care for these children. (Critical Care Nurse 2016; 36[4]:70-75). ©2016 American Association of Critical-Care Nurses.

Basics of Compounding: Clinical Pharmaceutics, Part 2.

PubMed

Allen, Loyd V

2016-01-01

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

Sports Medicine and Athletic Training in the 21st Century: Bridging the Gap between Research and Clinical Practice

ERIC Educational Resources Information Center

Guskiewicz, Kevin M.

2008-01-01

Sport and recreational activity is a vital part of today's society, and athletic training researchers are playing an important role in gaining a better understanding of how to promote safe and healthy participation for athletes of all ages. This article aims to illustrate the importance of research to prevent and effectively treat sport and…

Using digital multimedia to improve parents' and children's understanding of clinical trials.

PubMed

Tait, Alan R; Voepel-Lewis, Terri; Levine, Robert

2015-06-01

Data show that many research subjects have difficulty understanding study information using traditional paper consent documents. This study, therefore, was designed to evaluate the effect of an interactive multimedia program on improving parents' and children's understanding of clinical trial concepts and participation. Parents (n=148) and children (n=135) were each randomised to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with inline exercises. Participants' understanding of the information was assessed using semistructured interviews prior to (pretest) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process. Regardless of the mode of information delivery, all participants demonstrated improved pretest to post-test understanding. While there were no statistical differences in parents' post-test understanding between the TF and IP groups, children in the IP group had significantly greater post-test understanding compared with children in the TF group (11.65 (4.1) vs 8.85 (4.1) (2.8, 1.4, 4.2) 0-18 scale where 18=complete understanding). Furthermore, the IP was found to be significantly 'easier to follow' and 'more effective' in presenting information compared with the TF. Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children. Importantly, the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery, particularly among children, supports this approach as a novel and effective vehicle for enhancing the informed consent process. 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.

In vivo clinical and radiological effects of platelet-rich plasma on interstitial supraspinatus lesion: Case series.

PubMed

Lädermann, A; Zumstein, M A; Kolo, F C; Grosclaude, M; Koglin, L; Schwitzguebel, A J P

2016-12-01

Rotator cuff tear (RCT) is a frequent condition of clinical relevance that can be managed with a symptomatic conservative treatment, but surgery is often needed. Biological components like leukocytes and platelet rich plasma (L-PRP) could represent an alternative curative method for interstitial RCT. It has been hypothesized that an ultrasound guided L-PRP injection in supraspinatus interstitial RCT could induce radiological healing. A prospective case series including 25 patients was performed in order to assess the effect of L-PRP infiltration into supraspinatus interstitial RCTs. Primary outcome was tear size change determined by magnetic resonance imaging arthrogram (MRA) before and 6 months after L-PRP infiltration. Secondary outcomes were Constant score, SANE score, and pain visual analog scale (VAS) after L-PRP infiltration. Tear volume diminution was statistically significant (P=.007), and a >50% tear volume diminution was observed in 15 patients. A statistically significant improvement of Constant score (P<.001), SANE score (P=.001), and VAS (P<.001) was observed. In 21 patients, Constant score improvement reached the minimal clinical important difference of 10.4 points. We observed a statistically significant and clinically relevant effect on RCT size and clinical parameters after L-PRP infiltration. Such an important improvement of supraspinatus interstitial RCT with conservative management is uncommon, therefore intratendinous L-PRP infiltrations could have been beneficial. This encouraging result could pave the way for future randomized studies in order to formally determinate whether L-PRP infiltrations are a possible alternative to surgical treatment of interstitial RCT. Prospective observational study; Level of evidence II. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

The potential impact of recruitment method on sample characteristics and treatment outcomes in a psychosocial trial for women with co-occurring substance use disorder and PTSD.

PubMed

Winhusen, Theresa; Winstanley, Erin L; Somoza, Eugene; Brigham, Gregory

2012-01-01

Recruitment method can impact the sample composition of a clinical trial and, thus, the generalizability of the results, but the importance of recruitment method in substance use disorder trials has received little attention. The present paper sought to address this research gap by evaluating the association between recruitment method and sample characteristics and treatment outcomes in a substance use disorder trial. In a multi-site trial evaluating Seeking Safety (SS), relative to Women's Health Education (WHE), for women with co-occurring PTSD (either sub-threshold or full PTSD) and substance use disorders, one site assessed the method by which each participant was recruited. Data from this site (n=106), which recruited participants from newspaper advertising and clinic intakes, were analyzed. Participants recruited through advertising, relative to those from the clinic, had significantly higher levels of baseline drug use and higher rates of meeting DSM-IV-TR criteria for full PTSD. Results suggest that the effectiveness of SS in decreasing PTSD symptoms was greater for participants recruited through advertising relative to those recruited from the clinic. Conversely, the results revealed a significant treatment effect in the clinic-recruited participants, not seen in the advertising-recruited participants, with SS, relative to WHE, participants being more likely to report past week drug use during the follow-up phase. Recruitment method may impact sample composition and treatment effects. Replication of this finding would have important implications for substance use disorder efficacy trials which often utilize advertising to recruit participants. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Clinical processes in behavioral couples therapy.

PubMed

Fischer, Daniel J; Fink, Brandi C

2014-03-01

Behavioral couples therapy is a broad term for couples therapies that use behavioral techniques based on principles of operant conditioning, such as reinforcement. Behavioral shaping and rehearsal and acceptance are clinical processes found across contemporary behavioral couples therapies. These clinical processes are useful for assessment and case formulation, as well as teaching couples new methods of conflict resolution. Although these clinical processes assist therapists in achieving efficient and effective therapeutic change with distressed couples by rapidly stemming couples' corrosive affective exchanges, they also address the thoughts, emotions, and issues of trust and intimacy that are important aspects of the human experience in the context of a couple. Vignettes are provided to illustrate the clinical processes described. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

Producing Competent Doctors - The Art and Science of Teaching Clinical Skills.

PubMed

Dhaliwal, Upreet; Supe, Avinash; Gupta, Piyush; Singh, Tejinder

2017-05-15

For a doctor to provide medical care with competence, he must not only have knowledge but must also be able to translate that knowledge into action. It is his competence in clinical skills that will enable him to practice safely and effectively in the real world. To ensure acquisition of clinical skills, medical teachers must adopt teaching methods that prioritise observation, practice, feedback; and more practice. We try to elucidate the meaning of clinical skills, the challenges inherent in clinical skills training in India, training models that have shown success in practice and can be adopted in the Indian context, and various techniques to enhance skill-training, including the giving of feedback, which is a critically important component of skills development.

Classic hallucinogens in the treatment of addictions.

PubMed

Bogenschutz, Michael P; Johnson, Matthew W

2016-01-04

Addictive disorders are very common and have devastating individual and social consequences. Currently available treatment is moderately effective at best. After many years of neglect, there is renewed interest in potential clinical uses for classic hallucinogens in the treatment of addictions and other behavioral health conditions. In this paper we provide a comprehensive review of both historical and recent clinical research on the use of classic hallucinogens in the treatment of addiction, selectively review other relevant research concerning hallucinogens, and suggest directions for future research. Clinical trial data are very limited except for the use of LSD in the treatment of alcoholism, where a meta-analysis of controlled trials has demonstrated a consistent and clinically significant beneficial effect of high-dose LSD. Recent pilot studies of psilocybin-assisted treatment of nicotine and alcohol dependence had strikingly positive outcomes, but controlled trials will be necessary to evaluate the efficacy of these treatments. Although plausible biological mechanisms have been proposed, currently the strongest evidence is for the role of mystical or other meaningful experiences as mediators of therapeutic effects. Classic hallucinogens have an excellent record of safety in the context of clinical research. Given our limited understanding of the clinically relevant effects of classic hallucinogens, there is a wealth of opportunities for research that could contribute important new knowledge and potentially lead to valuable new treatments for addiction. Copyright © 2015 Elsevier Inc. All rights reserved.

Innovative strategies for early clinical R&D.

PubMed

Butz, Robert F; Morelli, Gaetano

2008-01-01

Developments in translational medicine and regulatory initiatives associated with the FDA's Critical Path Initiative are creating new opportunities for innovation in early clinical R&D. The introduction of the exploratory IND process allows small, 'phase 0' clinical trials to be conducted prior to traditional phase I trials - sometimes requiring considerably less chemistry, manufacturing and controls, or preclinical support. Phase 0 clinical trials involving subtherapeutic, yet pharmacologically active, dose levels can provide an early demonstration of clinical proof of concept; such demonstration is of particular importance to small pharmaceutical and early-stage biotechnology companies. However, these opportunities for rapid entry into the clinic must be balanced by a consideration of the unique risks associated with first-in-human clinical trials, and by accounting for public concerns regarding drug safety in general. This feature review discusses how innovative clinical strategies can be used effectively in early drug development.

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines

PubMed Central

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-01-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association’s governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research;Improving patient care provided by members by providing focus on quality and evidence;Creating legislative environments that favour effective clinical practice;Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; andIdentifying areas that require further information or research to improve clinical care.The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement. PMID:25314352

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines.

PubMed

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-10-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association's governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research; Improving patient care provided by members by providing focus on quality and evidence; Creating legislative environments that favour effective clinical practice; Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; and Identifying areas that require further information or research to improve clinical care. The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement.

Opportunities and pitfalls in clinical proof-of-concept: principles and examples.

PubMed

Chen, Chao

2018-04-01

Clinical proof-of-concept trials crucially inform major resource deployment decisions. This paper discusses several mechanisms for enhancing their rigour and efficiency. The importance of careful consideration when using a surrogate endpoint is illustrated; situational effectiveness of run-in patient enrichment is explored; a versatile tool is introduced to ensure a strong pharmacological underpinning; the benefits of dose-titration are revealed by simulation; and the importance of adequately scheduled observations is shown. The general process of model-based trial design and analysis is described and several examples demonstrate the value in historical data, simulation-guided design, model-based analysis and trial adaptation informed by interim analysis. Copyright © 2018 Elsevier Ltd. All rights reserved.

Bisphosphonate-Induced Osteonecrosis of the Maxilla Resembling a Persistent Endodontic Lesion.

PubMed

Mosaferi, Hossein; Fazlyab, Mahta; Sharifi, Sanaz; Rahimian, Sepideh

2016-01-01

A 52-year-old Caucasian woman suffering from pain in the anterior maxillary region, presented to the clinic. Examination revealed a draining sinus tract in the buccal vestibule of the maxilla in the left anterior segment and expansion in the middle of palate. On conventional radiographic examination the lesion was initially assumed to be a periapical problem related to the incisors but subsequently it was diagnosed to be a bisphosphonate osteonecrosis. Acquiring a comprehensive medical history from the patients, conducting the clinical vitality tests and most importantly being familiar with the non-odontogenic lesions that can be side effects of specific medications are important requirements for reaching a correct diagnosis.

Bisphosphonate-Induced Osteonecrosis of the Maxilla Resembling a Persistent Endodontic Lesion

PubMed Central

Mosaferi, Hossein; Fazlyab, Mahta; Sharifi, Sanaz; Rahimian, Sepideh

2016-01-01

A 52-year-old Caucasian woman suffering from pain in the anterior maxillary region, presented to the clinic. Examination revealed a draining sinus tract in the buccal vestibule of the maxilla in the left anterior segment and expansion in the middle of palate. On conventional radiographic examination the lesion was initially assumed to be a periapical problem related to the incisors but subsequently it was diagnosed to be a bisphosphonate osteonecrosis. Conclusion: Acquiring a comprehensive medical history from the patients, conducting the clinical vitality tests and most importantly being familiar with the non-odontogenic lesions that can be side effects of specific medications are important requirements for reaching a correct diagnosis. PMID:26843881

Exploring the environment of clinical baccalaureate nursing students' education in Iran; A qualitative descriptive study.

PubMed

Yousefy, Alireza; Yazdannik, Ahmad reza; Mohammadi, Sepideh

2015-12-01

Today's students are the nurses of tomorrow. They need appropriate clinical learning opportunities in order to shape their professional identity, attitudes and values. Despite undeniable progresses of nursing education in Iran, the quality of the clinical education in Iran is not favorable. There is a need to explore the environment of clinical baccalaureate nursing students' education for developing, maintaining and enhancing the quality of clinical program. This is a qualitative study and was conducted based on content analysis multimethod design. Data were collected by individual interviews, focus groups and direct observations. 54 nursing students and 8 clinical educators from the four geographically diverse universities in the Iran composed the study sample. A purposive sampling was used. Five themes were emerged from data analysis including; ambiguity in the nursing care role, routine-based nursing care, uncritical and dependent thinking climate, incompetency of clinical educators and patient education as important component of nursing. The findings of this study describe a clearer understanding of the real environment of the clinical education in Iran. All of themes that emerged from the study play an important role in student learning and nursing education. It is crucial to pay more attention to reconsider care concept as an operational component of nursing, maximize meaningful learning opportunities, reevaluate clinical instructor as role models and prepare effective operational plan to combine theoretical and evidence based knowledge with clinical practice. Copyright © 2015 Elsevier Ltd. All rights reserved.

Practice education learning environments: the mismatch between perceived and preferred expectations of undergraduate health science students.

PubMed

Brown, Ted; Williams, Brett; McKenna, Lisa; Palermo, Claire; McCall, Louise; Roller, Louis; Hewitt, Lesley; Molloy, Liz; Baird, Marilyn; Aldabah, Ligal

2011-11-01

Practical hands-on learning opportunities are viewed as a vital component of the education of health science students, but there is a critical shortage of fieldwork placement experiences. It is therefore important that these clinical learning environments are well suited to students' perceptions and expectations. To investigate how undergraduate students enrolled in health-related education programs view their clinical learning environments and specifically to compare students' perception of their 'actual' clinical learning environment to that of their 'preferred/ideal' clinical learning environment. The Clinical Learning Environment Inventory (CLEI) was used to collect data from 548 undergraduate students (55% response rate) enrolled in all year levels of paramedics, midwifery, radiography and medical imaging, occupational therapy, pharmacy, nutrition and dietetics, physiotherapy and social work at Monash University via convenience sampling. Students were asked to rate their perception of the clinical learning environment at the completion of their placements using the CLEI. Satisfaction of the students enrolled in the health-related disciplines was closely linked with the five constructs measured by the CLEI: Personalization, Student Involvement, Task Orientation, Innovation, and Individualization. Significant differences were found between the student's perception of their 'actual' clinical learning environment and their 'ideal' clinical learning environment. The study highlights the importance of a supportive clinical learning environment that places emphasis on effective two-way communication. A thorough understanding of students' perceptions of their clinical learning environments is essential. Copyright © 2010 Elsevier Ltd. All rights reserved.

RBE and related modeling in carbon-ion therapy

NASA Astrophysics Data System (ADS)

Karger, Christian P.; Peschke, Peter

2018-01-01

Carbon ion therapy is a promising evolving modality in radiotherapy to treat tumors that are radioresistant against photon treatments. As carbon ions are more effective in normal and tumor tissue, the relative biological effectiveness (RBE) has to be calculated by bio-mathematical models and has to be considered in the dose prescription. This review (i) introduces the concept of the RBE and its most important determinants, (ii) describes the physical and biological causes of the increased RBE for carbon ions, (iii) summarizes available RBE measurements in vitro and in vivo, and (iv) describes the concepts of the clinically applied RBE models (mixed beam model, local effect model, and microdosimetric-kinetic model), and (v) the way they are introduced into clinical application as well as (vi) their status of experimental and clinical validation, and finally (vii) summarizes the current status of the use of the RBE concept in carbon ion therapy and points out clinically relevant conclusions as well as open questions. The RBE concept has proven to be a valuable concept for dose prescription in carbon ion radiotherapy, however, different centers use different RBE models and therefore care has to be taken when transferring results from one center to another. Experimental studies significantly improve the understanding of the dependencies and limitations of RBE models in clinical application. For the future, further studies investigating quantitatively the differential effects between normal tissues and tumors are needed accompanied by clinical studies on effectiveness and toxicity.

Poly-(ADP-ribose)-polymerase inhibitors as radiosensitizers: a systematic review of pre-clinical and clinical human studies.

PubMed

Lesueur, Paul; Chevalier, François; Austry, Jean-Baptiste; Waissi, Waisse; Burckel, Hélène; Noël, Georges; Habrand, Jean-Louis; Saintigny, Yannick; Joly, Florence

2017-09-15

Poly-(ADP-Ribose)-Polymerase (PARP) inhibitors are becoming important actors of anti-neoplasic agents landscape, with recent but narrow FDA's approvals for ovarian BRCA mutated cancers and prostatic cancer. Nevertheless, PARP inhibitors are also promising drugs for combined treatments particularly with radiotherapy. More than seven PARP inhibitors have been currently developed. Central Role of PARP in DNA repair, makes consider PARP inhibitor as potential radiosensitizers, especially for tumors with DNA repair defects, such as BRCA mutation, because of synthetic lethality. Furthermore the replication-dependent activity of PARP inhibitor helps to maintain the differential effect between tumoral and healthy tissues. Inhibition of chromatin remodeling, G2/M arrest, vasodilatory effect induced by PARP inhibitor, also participate to their radio-sensitization effect. Here, after highlighting mechanisms of PARP inhibitors radiosensitization we methodically searched PubMed, Google Scholar, Cochrane Databases and meeting proceedings for human pre-clinical and clinical studies that evaluated PARP inhibitor radiosensitizing effect. Enhancement ratio, when available, was systematically reported. Sixty four studies finally met our selection criteria and were included in the analysis. Only three pre-clinical studies didn't find any radiosensitizing effect. Median enhancement ratio vary from 1,3 for prostate tumors to 1,5 for lung cancers. Nine phase I or II trials assessed safety data. PARP inhibitors are promising radiosensitizers, but need more clinical investigation. The next ten years will be determining for judging their real potential.

Minimum clinically important differences in chronic pain vary considerable by baseline pain and methodological factors: systematic review of empirical studies.

PubMed

Frahm Olsen, Mette; Bjerre, Eik; Hansen, Maria Damkjær; Tendal, Britta; Hilden, Jørgen; Hróbjartsson, Asbjørn

2018-05-21

The minimum clinically important difference (MCID) is used to interpret the relevance of treatment effects, e.g., when developing clinical guidelines, evaluating trial results or planning sample sizes. There is currently no agreement on an appropriate MCID in chronic pain and little is known about which contextual factors cause variation. This is a systematic review. We searched PubMed, EMBASE, and Cochrane Library. Eligible studies determined MCID for chronic pain based on a one-dimensional pain scale, a patient-reported transition scale of perceived improvement, and either a mean change analysis (mean difference in pain among minimally improved patients) or a threshold analysis (pain reduction associated with best sensitivity and specificity for identifying minimally improved patients). Main results were descriptively summarized due to considerable heterogeneity, which were quantified using meta-analyses and explored using subgroup analyses and metaregression. We included 66 studies (31.254 patients). Median absolute MCID was 23 mm on a 0-100 mm scale (interquartile range [IQR] 12-39) and median relative MCID was 34% (IQR 22-45) among studies using the mean change approach. In both cases, heterogeneity was very high: absolute MCID I 2  = 99% and relative MCID I 2  = 96%. High variation was also seen among studies using the threshold approach: median absolute MCID was 20 mm (IQR 15-30) and relative MCID was 32% (IQR 15-41). Absolute MCID was strongly associated with baseline pain, explaining approximately two-thirds of the variation, and to a lesser degree with the operational definition of minimum pain relief and clinical condition. A total of 15 clinical and methodological factors were assessed as possible causes for variation in MCID. MCID for chronic pain relief vary considerably. Baseline pain is strongly associated with absolute, but not relative, measures. To a much lesser degree, MCID is also influenced by the operational definition of relevant pain relief and possibly by clinical condition. Explicit and conscientious reflections on the choice of an MCID are required when classifying effect sizes as clinically important or trivial. Copyright © 2018 Elsevier Inc. All rights reserved.

The Clinical Practice of Assessing Cognitive Function in Adults Receiving Electroconvulsive Therapy: Whom Are We Missing?

PubMed

Obbels, Jasmien; Vanbrabant, Koen; Bouckaert, Filip; Verwijk, Esmée; Sienaert, Pascal

2016-06-01

Cognition can be affected by electroconvulsive therapy (ECT). Good clinical practice includes neuropsychological assessment, although this is seldom a part of routine clinical practice. It looks like a substantial part of patients fail to complete cognitive assessments. This constitutes a problem in the generalizability of published clinical research on cognitive side effects. Most studies of ECT-related cognitive adverse effects do not discuss this important issue of so-called cognitive test nonparticipants. Recent findings suggest that cognitive test nonparticipants are more severely ill, and probably more vulnerable to cognitive side effects. To examine the feasibility of a neuropsychological test battery in daily clinical practice, in an adult population referred for ECT. We reviewed the clinical records of 84 patients referred for ECT. Demographic and clinical characteristics of those patients who were able to complete our routine cognitive testing at baseline are compared with those who could not complete the assessment. From 84 ECT patients, 60 (71%) completed a pre-ECT cognitive assessment, whereas 24 (29%) did not. Patients with a unipolar depression, with psychotic symptoms, who started their treatment with a bitemporal electrode placement were more likely to be test noncompleters than test completers. Patients with a unipolar depression, with psychotic features, who are treated with a bitemporal electrode placement, have a higher likelihood of not completing a pre-ECT cognitive assessment. These patients probably represent a subgroup more vulnerable to cognitive side effects.

A decision-support system for the analysis of clinical practice patterns.

PubMed

Balas, E A; Li, Z R; Mitchell, J A; Spencer, D C; Brent, E; Ewigman, B G

1994-01-01

Several studies documented substantial variation in medical practice patterns, but physicians often do not have adequate information on the cumulative clinical and financial effects of their decisions. The purpose of developing an expert system for the analysis of clinical practice patterns was to assist providers in analyzing and improving the process and outcome of patient care. The developed QFES (Quality Feedback Expert System) helps users in the definition and evaluation of measurable quality improvement objectives. Based on objectives and actual clinical data, several measures can be calculated (utilization of procedures, annualized cost effect of using a particular procedure, and expected utilization based on peer-comparison and case-mix adjustment). The quality management rules help to detect important discrepancies among members of the selected provider group and compare performance with objectives. The system incorporates a variety of data and knowledge bases: (i) clinical data on actual practice patterns, (ii) frames of quality parameters derived from clinical practice guidelines, and (iii) rules of quality management for data analysis. An analysis of practice patterns of 12 family physicians in the management of urinary tract infections illustrates the use of the system.

Antidiabetic Properties of Germinated Brown Rice: A Systematic Review

PubMed Central

Bhanger, Muhammad Iqbal; Ismail, Norsharina; Ismail, Maznah

2012-01-01

Diet is an important variable in the course of type 2 diabetes, which has generated interest in dietary options like germinated brown rice (GBR) for effective management of the disease among rice-consuming populations. In vitro data and animal experiments show that GBR has potentials as a functional diet for managing this disease, and short-term clinical studies indicate encouraging results. Mechanisms for antidiabetic effects of GBR due to bioactive compounds like γ-aminobutyric acid (GABA), γ-oryzanol, dietary fibre, phenolics, vitamins, acylated steryl β-glucoside, and minerals include antihyperglycemia, low insulin index, antioxidative effect, antithrombosis, antihypertensive effect, hypocholesterolemia, and neuroprotective effects. The evidence so far suggests that there may be enormous benefits for diabetics in rice-consuming populations if white rice is replaced with GBR. However, long-term clinical studies are still needed to verify these findings on antidiabetic effects of GBR. Thus, we present a review on the antidiabetic properties of GBR from relevant preclinical and clinical studies, in order to provide detailed information on this subject for researchers to review the potential of GBR in combating this disease. PMID:23304216

Extrapyramidal side effects of antipsychotic treatment: scope of problem and impact on outcome.

PubMed

Tandon, Rajiv; Jibson, Michael D

2002-06-01

Previously, clinicians worked with antipsychotic drugs (conventional or typical) that almost invariably caused extrapyramidal symptoms (EPS) at clinically effective doses. This led to the false impression that all antipsychotics were the same, and that EPS were an unavoidable consequence of effective antipsychotic therapy. EPS adversely impact several aspects of antipsychotic efficacy and tolerability, thereby worsening outcome of afflicted individuals. EPS reduce beneficial effects of antipsychotic treatment on the negative, cognitive, and mood symptom domains, while increasing the risk of tardive dyskinesia and reducing compliance. By definition, the newer generation of "atypical" antipsychotic agents are significantly better than conventional agents with regard to EPS (i.e., they are clinically effective at doses at which they do not cause EPS). Pharmacologically, this difference is expressed in the greater degree of separation between respective dose response curves for antipsychotic and EPS effects observed for "atypical" in contrast to conventional agents. Clinically, this EPS advantage of atypical antipsychotics translates into several important benefits, including better negative symptom efficacy, less dysphoria, less impaired cognition, a lower risk of TD, and better overall outcome.

Interpretation of correlations in clinical research.

PubMed

Hung, Man; Bounsanga, Jerry; Voss, Maren Wright

2017-11-01

Critically analyzing research is a key skill in evidence-based practice and requires knowledge of research methods, results interpretation, and applications, all of which rely on a foundation based in statistics. Evidence-based practice makes high demands on trained medical professionals to interpret an ever-expanding array of research evidence. As clinical training emphasizes medical care rather than statistics, it is useful to review the basics of statistical methods and what they mean for interpreting clinical studies. We reviewed the basic concepts of correlational associations, violations of normality, unobserved variable bias, sample size, and alpha inflation. The foundations of causal inference were discussed and sound statistical analyses were examined. We discuss four ways in which correlational analysis is misused, including causal inference overreach, over-reliance on significance, alpha inflation, and sample size bias. Recent published studies in the medical field provide evidence of causal assertion overreach drawn from correlational findings. The findings present a primer on the assumptions and nature of correlational methods of analysis and urge clinicians to exercise appropriate caution as they critically analyze the evidence before them and evaluate evidence that supports practice. Critically analyzing new evidence requires statistical knowledge in addition to clinical knowledge. Studies can overstate relationships, expressing causal assertions when only correlational evidence is available. Failure to account for the effect of sample size in the analyses tends to overstate the importance of predictive variables. It is important not to overemphasize the statistical significance without consideration of effect size and whether differences could be considered clinically meaningful.

Framing of Feedback Impacts Student's Satisfaction, Self-Efficacy and Performance

ERIC Educational Resources Information Center

van de Ridder, J. M. Monica; Peters, Claudia M. M.; Stokking, Karel M.; de Ru, J. Alexander; ten Cate, Olle Th. J.

2015-01-01

Feedback is considered important to acquire clinical skills. Research evidence shows that feedback does not always improve learning and its effects may be small. In many studies, a variety of variables involved in feedback provision may mask either one of their effects. E.g., there is reason to believe that the way oral feedback is framed may…

Strategies for Data Collection in Social Skills Group Interventions: A Case Study

ERIC Educational Resources Information Center

Goforth, Anisa N.; Rennie, Brandon J.; Hammond, Julia; Schoffer Closson, Jennifer K.

2016-01-01

For many practitioners in schools and clinics, collecting data to show the effectiveness of an intervention is probably one of the most important yet challenging components of intervention implementation. This article provides practitioners with an example case study of how data can be organized and collected to determine the effectiveness of a…

[How to prevent hazards and to reduce risk in clinical trials?].

PubMed

Czarkowski, Marek

2008-12-01

Different stakeholders involved in clinical trials are exposed to hazards related with this biomedical research. Beside clinical trials participants other important stakeholders are: investigators, sponsors, centers and clinical research organizations. Hazard prevention needs effective methods of hazard disclosure and analysis. A reduction of risks related with clinical trials is possible due to education, training, inspections, research discipline and penalties. Effective ways of hazard elimination or hazard reduction should be developed as well. Education and training should be offered to all stakeholders but their forms and contents should be adapted to different types of stakeholders. Direct control of the clinical trials should be held by stakeholders conducting clinical trials and outside inspections should be done by other institutions like clinical research organizations, research ethics committees and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Serious oversight is an absence of any independent inspection during a phase of publication of clinical trial results. We should not accept any exception from the golden rule that results of all clinical trials must be published. Indemnity for damages is a popular way of compensation for clinical trials participants. Investigators, sponsors and centers should have valid liability insurance. Drastic measures for reduction of risks in clinical trials are different kinds of penalties. They should prevent participation of unreliable stakeholders and promote those who respect regulations and high ethical standards.

Pain management in the geriatric population.

PubMed

Borsheski, Robert; Johnson, Quinn L

2014-01-01

Pain is a highly prevalent and clinically important problem in the elderly. Unfortunately, due to difficulties in assessing pain in geriatric patients, the complexities of multiple comorbidities, and the high prevalence of polypharmacy, many practitioners are reluctant to treat pain aggressively in this unique patient population. Safe and effective treatment therefore, requires a working knowledge of the physiologic changes associated with aging, the challenges of accurately assessing pain, the unique effects of common therapeutic agents upon the elderly as well as the importance of adjunctive therapies. The following review is intended to provide the practitioner with practical knowledge for safer and more effective treatment of pain.

The laboratory workforce shortage: a managerial perspective.

PubMed

Cortelyou-Ward, Kendall; Ramirez, Bernardo; Rotarius, Timothy

2011-01-01

Most clinical laboratories in the nation report severe difficulties in recruitment and retention of most types of personnel. Other important factors impacting this problem include work complexities, increased automation, and a graying workforce. As a further challenge, institutional needs for clinical laboratory personnel are expected to grow significantly in the next decade. This article examines the current situation of the clinical laboratory workforce. It analyzes the different types of personnel; the managerial, supervision, and line positions that are key for different types of laboratories; the job outlook and recent projections for different types of staff; and the current issues, trends, and challenges of the laboratory workforce. Laboratory managers need to take action with strategies suggested for overcoming these challenges. Most importantly, they need to become transformational leaders by developing effective staffing models, fostering healthy and productive work environments, and creating value with a strategic management culture and implementation of knowledge management.

Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design

PubMed Central

Dokainish, Hisham; Elbarasi, Esam; Masiero, Simona; Van de Heyning, Caroline; Brambatti, Michela; Ghazal, Sami; AL-Maashani, Said; Capucci, Alessandro; Buikema, Lisanne; Leong, Darryl; Shivalkar, Bharati; Saenen, Johan; Miljoen, Hielko; Morillo, Carlos; Divarakarmenon, Syam; Amit, Guy; Ribas, Sebastian; Brautigam, Aaron; Baiocco, Erika; Maolo, Alessandro; Romandini, Andrea; Maffei, Simone; Connolly, Stuart; Healey, Jeff

2015-01-01

Given the increasing numbers of cardiac device implantations worldwide, it is important to determine whether permanent endocardial leads across the tricuspid valve can promote tricuspid regurgitation (TR). Virtually all current data is retrospective, and indicates a signal of TR being increased after permanent lead implantation. However, the precise incidence of moderate or greater TR post-procedure, the exact mechanisms (mechanical, traumatic, functional), and the hemodynamic burden and clinical effects of this putative increase in TR, remain uncertain. We have therefore designed a multicenter, international, prospective study of 300 consecutive patients (recruitment completed, baseline data presented) who will undergo echocardiography and clinical assessment prior to, and at 1-year post device insertion. This prospective study will help determine whether cardiac device-associated TR is real, what are its potential mechanisms, and whether it has an important clinical impact on cardiac device patients. PMID:26779517

Effective Strategies for Affordable Care Act Enrollment in Immigrant-Serving Safety Net Clinics in New Mexico.

PubMed

Getrich, Christina M; García, Jacqueline M; Solares, Angélica; Kano, Miria

2017-01-01

In the new Affordable Care Act (ACA) health care environment, safety-net institutions continue to serve as important sources of culturally appropriate care for different groups of immigrant patients. This article reports on a qualitative study examining the early ACA enrollment experiences of a range of health care providers (n = 29) in six immigrant-serving safety-net clinics in New Mexico. The six clinics configured their ACA enrollment strategies differently with regard to operations, staffing, and outreach. Providers reported a generally chaotic rollout overall and expressed frustration with strategies that did not accommodate patients, provided little training for providers, and engaged in minimal outreach. Conversely, providers lauded strategies that flexibly met patient needs, leveraged trust through strategic use of staff, and prioritized outreach. Findings underscore the importance of using and funding concerted strategies for future enrollment of immigrant patients, such as featuring community health workers and leveraging trust for outreach.

Mitochondrial disorders: Challenges in diagnosis & treatment

PubMed Central

Khan, Nahid Akhtar; Govindaraj, Periyasamy; Meena, Angamuthu Kannan; Thangaraj, Kumarasamy

2015-01-01

Mitochondrial dysfunctions are known to be responsible for a number of heterogenous clinical presentations with multi-systemic involvement. Impaired oxidative phosphorylation leading to a decrease in cellular energy (ATP) production is the most important cause underlying these disorders. Despite significant progress made in the field of mitochondrial medicine during the last two decades, the molecular mechanisms underlying these disorders are not fully understood. Since the identification of first mitochondrial DNA (mtDNA) mutation in 1988, there has been an exponential rise in the identification of mtDNA and nuclear DNA mutations that are responsible for mitochondrial dysfunction and disease. Genetic complexity together with ever widening clinical spectrum associated with mitochondrial dysfunction poses a major challenge in diagnosis and treatment. Effective therapy has remained elusive till date and is mostly efficient in relieving symptoms. In this review, we discuss the important clinical and genetic features of mitochondrials disorders with special emphasis on diagnosis and treatment. PMID:25857492

Teaching and assessing professionalism in medicine.

PubMed

Duff, Patrick

2004-12-01

Professionalism is the single most important of the clinical competencies. Lack of professional behavior, in turn, is the single most common cause for disciplinary action against third and fourth-year medical students, residents, fellows, and clinical practitioners. Desirable professional attributes include humility, honesty, responsibility, reliability, and accountability. The ability to preserve an appropriate balance between patient care responsibilities and personal commitments also is an important feature of professional behavior. Altruism, respectfulness, loyalty, compassion, sensitivity, and tactfulness are other desirable professional attributes. In addition, professionalism requires a heightened sense of intellectual curiosity, insight into personal strengths and weaknesses, maturity, and commitment to clinical excellence and self-directed learning. Professionalism can be taught and assessed through lectures, small-group seminars, role-playing exercises, directed reading, and one-on-one observation and counseling. However, the most effective way of teaching professionalism is for instructors to model appropriate behavior and to impose a consistent policy of zero tolerance for unprofessional behavior.

Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect.

PubMed

Mintzes, Barbara; Lexchin, Joel; Quintano, Ancella Santos

2015-01-01

Although selective and incomplete publication is widely acknowledged to be a problem, full access to clinical trial data remains illusive. Authors' personal files, key documents from Food and Drug Administration and European Medicines Agency and focussed searches of PubMed. Existing sources of information provide an incomplete overview of scientific research. Persistent arguments about commercial confidentiality and the potential difficulties in de-identifying raw data can block important progress. Current industry efforts are voluntary and only partially satisfy the need for complete data. Requirements for trial registration are increasing. Important regulatory changes in particular in Europe have the potential to result in the release of more information. Documenting the effects of prospective trial registration and requirements for proactive clinical trial publication on healthcare decisions, public health and rational resource allocation. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Clinical review: Neuromonitoring - an update

PubMed Central

2013-01-01

Critically ill patients are frequently at risk of neurological dysfunction as a result of primary neurological conditions or secondary insults. Determining which aspects of brain function are affected and how best to manage the neurological dysfunction can often be difficult and is complicated by the limited information that can be gained from clinical examination in such patients and the effects of therapies, notably sedation, on neurological function. Methods to measure and monitor brain function have evolved considerably in recent years and now play an important role in the evaluation and management of patients with brain injury. Importantly, no single technique is ideal for all patients and different variables will need to be monitored in different patients; in many patients, a combination of monitoring techniques will be needed. Although clinical studies support the physiologic feasibility and biologic plausibility of management based on information from various monitors, data supporting this concept from randomized trials are still required. PMID:23320763

Acetaminophen (paracetamol) oral absorption and clinical influences.

PubMed

Raffa, Robert B; Pergolizzi, Joseph V; Taylor, Robert; Decker, John F; Patrick, Jeffrey T

2014-09-01

Acetaminophen (paracetamol) is a widely used nonopioid, non-NSAID analgesic that is effective against a variety of pain types, but the consequences of overdose can be severe. Because acetaminophen is so widely available as a single agent and is increasingly being formulated in fixed-ratio combination analgesic products for the potential additive or synergistic analgesic effect and/or reduced adverse effects, accidental cumulative overdose is an emergent concern. This has rekindled interest in the sites, processes, and pharmacokinetics of acetaminophen oral absorption and the clinical factors that can influence these. The absorption of oral acetaminophen occurs primarily along the small intestine by passive diffusion. Therefore, the rate-limiting step is the rate of gastric emptying into the intestines. Several clinical factors can affect absorption per se or the rate of gastric emptying, such as diet, concomitant medication, surgery, pregnancy, and others. Although acetaminophen does not have the abuse potential of opioids or the gastrointestinal bleeding or organ adverse effects of NSAIDs, excess amounts can produce serious hepatic injury. Thus, an understanding of the sites and features of acetaminophen absorption--and how they might be influenced by factors encountered in clinical practice--is important for pain management using this agent. It can also provide insight for design of formulations that would be less susceptible to clinical variables. © 2013 World Institute of Pain.

Clinical effects of probiotics in cystic fibrosis patients: A systematic review.

PubMed

Van Biervliet, Stephanie; Declercq, Dimitri; Somerset, Shawn

2017-04-01

Cystic fibrosis (CF) is characterised by a build-up of thick, intransient mucus linings of the digestive and respiratory mucosa, which disrupts digestive system functioning and microbiota composition. In view of the potential for probiotics to enhance microbiota composition in other contexts, this study investigated the current evidence for probiotics as an adjunct to usual therapy for CF. Electronic clinical databases were interrogated for human randomised, controlled, intervention trials (1985-2015) testing the effects of probiotics on clinical endpoints in CF were reviewed. From 191 articles identified in initial searches, six studies met the critical inclusion criteria, and were reviewed in detail. These studies varied in size (n = 22 to 61) but were generally small and showed substantial diversity in protocol, specific probiotic species used and range of clinical outcomes measured. Probiotic administration showed beneficial effects on fecal calprotectin levels, pulmonary exacerbation risk, and quality of life indicators. In one study, such changes were associated with variations in gut microbiota composition. Despite encouraging preliminary results, the limited number of small and highly varied studies to date do not justify the addition of probiotics as an adjunct to current CF treatment protocols. Importantly, very minimal adverse effects of probiotics have been reported. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Contextualizing the relevance of basic sciences: small-group simulation with debrief for first- and second-year medical students in an integrated curriculum.

PubMed

Ginzburg, Samara B; Brenner, Judith; Cassara, Michael; Kwiatkowski, Thomas; Willey, Joanne M

2017-01-01

There has been a call for increased integration of basic and clinical sciences during preclinical years of undergraduate medical education. Despite the recognition that clinical simulation is an effective pedagogical tool, little has been reported on its use to demonstrate the relevance of basic science principles to the practice of clinical medicine. We hypothesized that simulation with an integrated science and clinical debrief used with early learners would illustrate the importance of basic science principles in clinical diagnosis and management of patients. Small groups of first- and second-year medical students were engaged in a high-fidelity simulation followed by a comprehensive debrief facilitated by a basic scientist and clinician. Surveys including anchored and open-ended questions were distributed at the conclusion of each experience. The majority of the students agreed that simulation followed by an integrated debrief illustrated the clinical relevance of basic sciences (mean ± standard deviation: 93.8% ± 2.9% of first-year medical students; 96.7% ± 3.5% of second-year medical students) and its importance in patient care (92.8% of first-year medical students; 90.4% of second-year medical students). In a thematic analysis of open-ended responses, students felt that these experiences provided opportunities for direct application of scientific knowledge to diagnosis and treatment, improving student knowledge, simulating real-world experience, and developing clinical reasoning, all of which specifically helped them understand the clinical relevance of basic sciences. Small-group simulation followed by a debrief that integrates basic and clinical sciences is an effective means of demonstrating the relationship between scientific fundamentals and patient care for early learners. As more medical schools embrace integrated curricula and seek opportunities for integration, our model is a novel approach that can be utilized.

Effective utilization of clinical laboratories.

PubMed

Murphy, J; Henry, J B

1978-11-01

Effective utilization of clinical laboratories requires that underutilization, overutilization, and malutilization be appreciated and eliminated or reduced. Optimal patient care service, although subjective to a major extent, is reflected in terms of outcome and cost. Increased per diem charges, reduced hospital stay, and increased laboratory workload over the past decade all require each laboratory to examine its internal operations to achieve economy and efficiency as well as maximal effectiveness. Increased research and development, an active managerial role on the part of pathologists, internal self-assessment, and an aggressive response to sophisticated scientific and clinical laboratory data base requirements are not only desirable but essential. The importance of undergraduate and graduate medical education in laboratory medicine to insure understanding as well as effective utilization is stressed. The costs and limitations as well as the accuracy, precision, sensitivity, specificity, and pitfalls of measurements and examinations must also be fully appreciated. Medical malpractice and defensive medicine and the use of critical values, emergency and routine services, and an active clinical role by the pathologist are of the utmost value in assuring effective utilization of the laboratory. A model for the optimal use of the laboratory including economy and efficiency has been achieved in the blood bank in regard to optimal hemotherapy for elective surgery, assuring superior patient care in a cost effective and safe manner.

The ENDOCARE questionnaire guides European endometriosis clinics to improve the patient-centeredness of their care.

PubMed

Dancet, E A F; Apers, S; Kluivers, K B; Kremer, J A M; Sermeus, W; Devriendt, C; Nelen, W L D M; D'Hooghe, T M

2012-11-01

How patient-centered are two included specialized endometriosis clinics relative to each other and how can they improve the patient-centeredness of their care? The validated ENDOCARE questionnaire (ECQ) reliably concluded that the adjusted overall patient-centeredness did not differ between the clinics, that each clinic was significantly more patient-centered for 2 out of 10 dimensions of patient-centered endometriosis care and that clinics 1 and 2 had to improve 8 and 13 specific care aspects, respectively. Patient-centered endometriosis care is essential to high-quality care and is defined by 10 dimensions. The ECQ was developed, validated and proved to be reliable in a European setting of self-reported endometriosis patients but had not yet been used at a clinic level for quality management. A cross-sectional survey was disseminated in 2011 to all 514 women diagnosed with endometriosis during a laparoscopy indicated for pain and/or infertility during a retrospective 2-year period (2009-2010) in two university clinics from two different European countries. In total 337 patients completed the ECQ (216 and 121 per clinic). Respondents had a mean age of 34.3 years. Three in four reported a surgical diagnosis of moderate or severe endometriosis and the majority reported surgical treatment by a multidisciplinary team. The ECQ assessed the 10 dimensions of patient-centeredness, more specifically whether the health-care performance, as perceived by patients, measured up to what is important to patients in general. The ECQ was completed by 337 respondents (response rate = 65.6%). Reliability and validity of the ECQ for use on clinic level were confirmed. Clinics did not differ in overall mean importance scores; importance rankings of the ECQ dimensions were almost identical. The overall patient-centeredness scores (PCS), adjusted for education level, did not discriminate between the clinics. However, the adjusted PCS for the dimensions 'clinic staff' and 'technical skills' were significantly better in clinic 1, whereas the dimensions 'physical comfort' and 'access to care' were significantly better in clinic 2. There were 8 (clinic 1) and 13 (clinic 2) targets identified for joint and cross-clinic improvement. Response rates were relatively high. Recall bias was the most important limitation and research in more clinics is needed to define the statistical discriminative value of the ECQ. European endometriosis clinics can use the validated ECQ for reliable assessment of their 'patient-centeredness', for comparison with others and for setting specific targets to improve the patient-centeredness of their endometriosis care, to plan interventions, and to evaluate their effectiveness. This work was funded by KU Leuven and European Network of Endometriosis (ENE), supported by the European Commission (Public Health Executive Agency). No competing interests are declared.

Which potential harms and benefits of using ginger in the management of nausea and vomiting of pregnancy should be addressed? a consensual study among pregnant women and gynecologists.

PubMed

Shawahna, Ramzi; Taha, Assim

2017-04-08

Nausea and vomiting of pregnancy (NVP) affect approximately 80-90% of the pregnant women. Ginger (Zingiber officinale Roscoe) is the most widely used herbal therapy in the management of NVP. Like conventional therapies, herbal therapies have potential harms and benefits that patients need to be informed about in order to develop their therapy preferences. The aim of this study was to achieve consensus among women who suffered NVP and physicians often consulted by pregnant women on a core list of potential harms and benefits of using ginger to manage NVP to be addressed during clinical consultations. In this study, the Delphi technique was used to achieve consensus on a core list of important harms and benefits of using ginger in the management of NVP to be addressed during the clinical consultation. A Delphi process was followed in two panels in parallel sessions. One panel was composed of 50 gynecologists and other physicians who are often consulted by pregnant women suffering NVP and the other panel was composed of 50 women who suffered NVP. Consensus was achieved on 21 (75%) of the 28 potential harms presented to the panelists. Panelists agreed that potential harms of the anticoagulant effects of ginger, risk with other co-morbidities, and risk of potential allergic reactions are important to address during the clinical consultation. Of the 14 potential benefits presented to the panelists in both panels, consensus was achieved on 13 (92.9%). Partial consensus on 7 potential harms and 1 potential benefit was achieved in both panels. Addressing important potential harms and benefits of using ginger for the management of NVP during the clinical consultations is important in promoting congruence and reducing patient dissatisfaction in clinical practice. Consensus was achieved on a core list of important harms and benefits of using ginger for the management of NVP to be addressed during the clinical consultations by a panel of women and a panel of physicians. Further studies are still needed to investigate what is being addressed during clinical consultations.

Controlled clinical trial of cannabidiol in Huntington's disease.

PubMed

Consroe, P; Laguna, J; Allender, J; Snider, S; Stern, L; Sandyk, R; Kennedy, K; Schram, K

1991-11-01

Based on encouraging preliminary findings, cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, was evaluated for symptomatic efficacy and safety in 15 neuroleptic-free patients with Huntington's Disease (HD). The effects of oral CBD (10 mg/kg/day for 6 weeks) and placebo (sesame oil for 6 weeks) were ascertained weekly under a double-blind, randomized cross-over design. A comparison of the effects of CBD and placebo on chorea severity and other therapeutic outcome variables, and on a Cannabis side effect inventory, clinical lab tests and other safety outcome variables, indicated no significant (p greater than 0.05) or clinically important differences. Correspondingly, plasma levels of CBD were assayed by GC/MS, and the weekly levels (mean range of 5.9 to 11.2 ng/ml) did not differ significantly over the 6 weeks of CBD administration. In summary, CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with HD.

Clinical review: Breast development in trans women receiving cross-sex hormones.

PubMed

Wierckx, Katrien; Gooren, Louis; T'Sjoen, Guy

2014-05-01

In trans women (male-to-female transsexual persons), cross-sex hormone therapy is administered to induce feminization. Breast development is an important part of feminization for most trans women. The aim of this study is to assess the effect of cross-sex hormone therapy on breast development in adult trans women. Additionally, we aimed to investigate the benefit or harm of administration of progestogens on breast development. A review of the literature in Embase, Medline, The Cochrane Library, PsycINFO databases, PubMed, and Web of Knowledge until January 2014. Effects of cross-sex hormone therapy and progestogens on breast development in trans women. Only few studies with low quality of evidence addressed these topics. The available evidence suggests that breast development is insufficient for the majority of trans women and that type and dosage of hormonal therapy seem not to have an important role on final breast size. Our knowledge concerning the natural history and effects of different cross-sex hormone therapies on breast development in trans women is extremely sparse and based on low quality of evidence. Current evidence does not provide evidence that progestogens enhance breast development in trans women. Neither do they prove the absence of such an effect. This prevents us from drawing any firm conclusion at this moment and demonstrates the need for further research to clarify these important clinical questions. © 2014 International Society for Sexual Medicine.

A pharmacokinetic-pharmacodynamic model for intrathecal baclofen in patients with severe spasticity.

PubMed

Heetla, H W; Proost, J H; Molmans, B H; Staal, M J; van Laar, T

2016-01-01

Intrathecal baclofen (ITB) has proven to be an effective and safe treatment for severe spasticity. However, although ITB is used extensively, clinical decisions are based on very scarce pharmacokinetic-pharmacodynamic (PKPD) data. The aim of this study was to measure baclofen CSF concentrations and clinical effects after administration of various ITB boluses in patients with spasticity and to create a PKPD model for ITB. Twelve patients with severe spasticity received four different bolus doses of ITB (0, 25, 50, 75 μg and an optional dose of 100 μg), administered via a catheter with the tip at thoracic level (Th) 10. After each bolus, 10 CSF samples were taken at fixed time intervals, using a catheter with the tip located at Th12. Clinical effect was assessed by measuring spasticity with the Modified Ashworth Scale (MAS). These data were used to develop a PKPD model. All patients achieved an adequate spasmolytic effect with ITB doses varying from 50 to 100 μg. No serious side effects were observed. CSF baclofen concentrations, as well as the clinical effects, correlated significantly with ITB doses. The PK model predicted a steep spinal concentration gradient of ITB along the spinal axis. The clinical effect could be predicted using a delayed-effect model. ITB is an effective and safe therapy with, however, a steep concentration gradient along the spinal axis. This means that the administered baclofen is staying mainly around the catheter tip, which stresses the importance to position the ITB catheter tip closely to the targeted spinal level. © 2015 The British Pharmacological Society.

Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus.

PubMed

Evers, Andrea W M; Colloca, Luana; Blease, Charlotte; Annoni, Marco; Atlas, Lauren Y; Benedetti, Fabrizio; Bingel, Ulrike; Büchel, Christian; Carvalho, Claudia; Colagiuri, Ben; Crum, Alia J; Enck, Paul; Gaab, Jens; Geers, Andrew L; Howick, Jeremy; Jensen, Karin B; Kirsch, Irving; Meissner, Karin; Napadow, Vitaly; Peerdeman, Kaya J; Raz, Amir; Rief, Winfried; Vase, Lene; Wager, Tor D; Wampold, Bruce E; Weimer, Katja; Wiech, Katja; Kaptchuk, Ted J; Klinger, Regine; Kelley, John M

2018-06-12

Placebo and nocebo effects occur in clinical or laboratory medical contexts after administration of an inert treatment or as part of active treatments and are due to psychobiological mechanisms such as expectancies of the patient. Placebo and nocebo studies have evolved from predominantly methodological research into a far-reaching interdisciplinary field that is unravelling the neurobiological, behavioural and clinical underpinnings of these phenomena in a broad variety of medical conditions. As a consequence, there is an increasing demand from health professionals to develop expert recommendations about evidence-based and ethical use of placebo and nocebo effects for clinical practice. A survey and interdisciplinary expert meeting by invitation was organized as part of the 1st Society for Interdisciplinary Placebo Studies (SIPS) conference in 2017. Twenty-nine internationally recognized placebo researchers participated. There was consensus that maximizing placebo effects and minimizing nocebo effects should lead to better treatment outcomes with fewer side effects. Experts particularly agreed on the importance of informing patients about placebo and nocebo effects and training health professionals in patient-clinician communication to maximize placebo and minimize nocebo effects. The current paper forms a first step towards developing evidence-based and ethical recommendations about the implications of placebo and nocebo research for medical practice, based on the current state of evidence and the consensus of experts. Future research might focus on how to implement these recommendations, including how to optimize conditions for educating patients about placebo and nocebo effects and providing training for the implementation in clinical practice. © 2018 S. Karger AG, Basel.

The role of depression pharmacogenetic decision support tools in shared decision making.

PubMed

Arandjelovic, Katarina; Eyre, Harris A; Lenze, Eric; Singh, Ajeet B; Berk, Michael; Bousman, Chad

2017-10-29

Patients discontinue antidepressant medications due to lack of knowledge, unrealistic expectations, and/or unacceptable side effects. Shared decision making (SDM) invites patients to play an active role in their treatment and may indirectly improve outcomes through enhanced engagement in care, adherence to treatment, and positive expectancy of medication outcomes. We believe decisional aids, such as pharmacogenetic decision support tools (PDSTs), facilitate SDM in the clinical setting. PDSTs may likewise predict drug tolerance and efficacy, and therefore adherence and effectiveness on an individual-patient level. There are several important ethical considerations to be navigated when integrating PDSTs into clinical practice. The field requires greater empirical research to demonstrate clinical utility, and the mechanisms thereof, as well as exploration of the ethical use of these technologies.

Prazosin for Veterans with Posttraumatic Stress Disorder and Comorbid Alcohol Dependence: A Clinical Trial.

PubMed

Petrakis, Ismene L; Desai, Nitigna; Gueorguieva, Ralitza; Arias, Albert; O'Brien, Erin; Jane, J Serrita; Sevarino, Kevin; Southwick, Steven; Ralevski, Elizabeth

2016-01-01

Posttraumatic stress disorder (PTSD) is an important and timely clinical issue particularly for combat veterans. Few pharmacologic options are available to treat PTSD, particularly among military personnel, and they are not based on rational neurobiology. The evidence for noradrenergic dysregulation in PTSD is strong, and the alpha-adrenergic agonist prazosin is one of the most promising medications to treat sleep disturbances associated with PTSD as well as PTSD symptoms among both veterans and civilians. Evidence also implicates noradrenergic dysregulation in the pathophysiology of alcohol dependence (AD); prazosin also may have efficacy in treating this disorder. The use of prazosin represents a rational and compelling approach for the treatment of PTSD and comorbid AD. Given the high rates of comorbid AD in trauma survivors with PTSD, and the enormous impact that these comorbid disorders have on psychosocial function and well-being, finding effective treatments for this population is of high clinical importance. Ninety-six veterans with PTSD and comorbid AD were randomized to receive prazosin (16 mg) or placebo in an outpatient, randomized, double-blind, clinical trial for 13 weeks. Main outcomes included symptoms of PTSD, sleep disturbances, and alcohol use. Symptoms of PTSD improved over time, but contrary to the hypothesis, there was no medication effect on PTSD symptoms, or on sleep. Alcohol consumption also decreased over time, but there were no significant differences in outcomes between medication groups. Prazosin was not effective in treating PTSD symptoms, improving sleep, or reducing alcohol consumption overall in this dually diagnosed group. This does not support the use of prazosin in an actively drinking population and suggests that the presence of a comorbid condition affects the efficacy of this medication. This study highlights the importance of conducting clinical trials in "real-world" patients, as results may vary based on comorbid conditions. Copyright © 2015 by the Research Society on Alcoholism. This article has been contributed to by US Government employees and their work is in the public domain in the USA.

When It Comes to Lifestyle Recommendations, More is Sometimes Less: A Meta-Analysis of Theoretical Assumptions Underlying the Effectiveness of Interventions Promoting Multiple Behavior Domain Change

PubMed Central

Wilson, Kristina; Senay, Ibrahim; Durantini, Marta; Sánchez, Flor; Hennessy, Michael; Spring, Bonnie; Albarracín, Dolores

2016-01-01

A meta-analysis of 150 research reports summarizing the results of multiple behavior domain interventions examined theoretical predictions about the effects of the included number of recommendations on behavioral and clinical change in the domains of smoking, diet, and physical activity. The meta-analysis yielded three main conclusions. First, there is a curvilinear relation between the number of behavioral recommendations and improvements in behavioral and clinical measures, with a moderate number of recommendations producing the highest level of change. A moderate number of recommendations is likely to be associated with stronger effects because the intervention ensures the necessary level of motivation to implement the recommended changes, thereby increasing compliance with the goals set by the intervention, without making the intervention excessively demanding. Second, this curve was more pronounced when samples were likely to have low motivation to change, such as when interventions were delivered to non-patient (vs. patient) populations, were implemented in non-clinic (vs. clinic) settings, used lay community (vs. expert) facilitators, and involved group (vs. individual) delivery formats. Finally, change in behavioral outcomes mediated the effects of number of recommended behaviors on clinical change. These findings provide important insights that can help guide the design of effective multiple behavior domain interventions. PMID:25528345

The use of clinical trials in comparative effectiveness research on mental health

PubMed Central

Blanco, Carlos; Rafful, Claudia; Olfson, Mark

2013-01-01

Objectives A large body of research on comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health. Study Design and Setting Examination of three ongoing randomized clinical trials in psychiatry that address issues which would pose difficulties for non-experimental CER methods. Results Existing statistical approaches to non-experimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout. Conclusions Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult to reach populations or when examining sequential treatments or stepped-care algorithms. Progress in CER in mental health will require careful consideration of appropriate selection between clinical trials and non-experimental designs and on allocation of research resources to optimally inform key treatment decisions for each individual patient. PMID:23849150

Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency.

PubMed

Anker, Stefan D; Schroeder, Stefan; Atar, Dan; Bax, Jeroen J; Ceconi, Claudio; Cowie, Martin R; Crisp, Adam; Dominjon, Fabienne; Ford, Ian; Ghofrani, Hossein-Ardeschir; Gropper, Savion; Hindricks, Gerhard; Hlatky, Mark A; Holcomb, Richard; Honarpour, Narimon; Jukema, J Wouter; Kim, Albert M; Kunz, Michael; Lefkowitz, Martin; Le Floch, Chantal; Landmesser, Ulf; McDonagh, Theresa A; McMurray, John J; Merkely, Bela; Packer, Milton; Prasad, Krishna; Revkin, James; Rosano, Giuseppe M C; Somaratne, Ransi; Stough, Wendy Gattis; Voors, Adriaan A; Ruschitzka, Frank

2016-05-01

Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and have adequate power to draw conclusions about the efficacy and safety of new treatments for heart failure. Additionally, the societal and health system perspectives on heart failure have raised interest in ascertaining the effects of therapy on outcomes such as repeat hospitalization and the patient's burden of disease. Thus, novel methods for using composite endpoints in clinical trials (e.g. clinical status composite endpoints, recurrent event analyses) are being applied in current and planned trials. Endpoints that measure functional status or reflect the patient experience are important but used cautiously because heart failure treatments may improve function yet have adverse effects on mortality. This paper discusses the use of traditional and new composite endpoints, identifies qualities of robust composites, and outlines opportunities for future research. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

A survey of informatics platforms that enable distributed comparative effectiveness research using multi-institutional heterogeneous clinical data

PubMed Central

Sittig, Dean F.; Hazlehurst, Brian L.; Brown, Jeffrey; Murphy, Shawn; Rosenman, Marc; Tarczy-Hornoch, Peter; Wilcox, Adam B.

2012-01-01

Comparative Effectiveness Research (CER) has the potential to transform the current healthcare delivery system by identifying the most effective medical and surgical treatments, diagnostic tests, disease prevention methods and ways to deliver care for specific clinical conditions. To be successful, such research requires the identification, capture, aggregation, integration, and analysis of disparate data sources held by different institutions with diverse representations of the relevant clinical events. In an effort to address these diverse demands, there have been multiple new designs and implementations of informatics platforms that provide access to electronic clinical data and the governance infrastructure required for inter-institutional CER. The goal of this manuscript is to help investigators understand why these informatics platforms are required and to compare and contrast six, large-scale, recently funded, CER-focused informatics platform development efforts. We utilized an 8-dimension, socio-technical model of health information technology use to help guide our work. We identified six generic steps that are necessary in any distributed, multi-institutional CER project: data identification, extraction, modeling, aggregation, analysis, and dissemination. We expect that over the next several years these projects will provide answers to many important, and heretofore unanswerable, clinical research questions. PMID:22692259

Basic and Clinical Research Against Advanced Glycation End Products (AGEs): New Compounds to Tackle Cardiovascular Disease and Diabetic Complications.

PubMed

Nenna, Antonio; Spadaccio, Cristiano; Lusini, Mario; Ulianich, Luca; Chello, Massimo; Nappi, Francesco

2015-01-01

Diabetes is a major risk factor for cardiovascular disease, and recent advances in research indicate that a detailed understanding of the pathophysiology of its effects is mandatory to reduce diabetes-related mortality and morbidity. Advanced Glycation End Products (AGEs) play a central role in the genesis and progression of complications of both type 1 and type 2 diabetes mellitus, and have been found to be important even in non-diabetic patients as a marker of cardiovascular disease. AGEs have a profound impact on patient's prognosis regardless of the glycemic control, and therefore pharmacologic approaches against AGEs accumulation have been proposed over the years to treat cardiovascular diseases, parallel to a more detailed understanding of AGEs pathophysiology. Compounds with anti-AGEs effects are currently under investigation in both pre-clinical and clinical scenarios, and many of the drugs previously used to treat specific diseases have been found to have AGE-inhibitory effects. Some products are still in "bench evaluation", whereas others have been already investigated in clinical trials with conflicting evidences. This review aims at summarizing the mechanisms of AGEs formation and accumulation, and the most relevant issues in pre-clinical and clinical experiences in anti-AGEs treatment in cardiovascular research.

Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations.

PubMed

Kotrla Topic, Marina; Perkovic Kovacevic, Marina; Mlacic, Boris

2012-10-01

To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N=92) and non-clinical (high-school students, N=87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from 0.000 to 0.021) with Autodestructiveness and Suicidal Depression, even after controlling for the sex and group effects or, when analyzing Suicidal Depression, after controlling the effect of other subscales. The results indicate that dimensions of the Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior.

Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations

PubMed Central

Kotrla Topić, Marina; Perković Kovačević, Marina; Mlačić, Boris

2012-01-01

Aim To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Methods Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N = 92) and non-clinical (high-school students, N = 87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Results Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from <0.001 to 0.021) with Autodestructivness and Suicidal Depression, even after controlling for the sex and group effects or, when analyzing Suicidal Depression, after controlling the effect of other subscales. Conclusion The results indicate that dimensions of the Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior. PMID:23100207

The role of the independent clinical laboratory in new assay development and commercialization.

PubMed

Ellis, David G

2003-01-01

Most would agree that these are exciting times in the field of laboratory medicine. As the body of scientific knowledge expands and research activities, such as those catalyzed by the sequencing of the human genome, bring us closer to the promise of personalized medicine, the clinical laboratory industry will have increasing opportunities to partner with owners of intellectual property to develop and commercialize new diagnostic tests. The large, independent clinical laboratories are particularly well positioned to commercialize important new tests, with their broad market penetration, infrastructure, and the scale to run esoteric tests cost-effectively.

Zika virus vaccines.

PubMed

Abbink, Peter; Stephenson, Kathryn E; Barouch, Dan H

2018-06-19

The recent epidemic of Zika virus (ZIKV) in the Americas has revealed the devastating consequences of ZIKV infection, particularly in pregnant women. Congenital Zika syndrome, characterized by malformations and microcephaly in neonates as well as developmental challenges in children, highlights the need for the development of a safe and effective vaccine. Multiple vaccine candidates have been developed and have shown promising results in both animal models and phase I clinical trials. However, important challenges remain for the clinical development of these vaccines. In this Progress article, we discuss recent preclinical studies and lessons learned from first-in-human clinical trials with ZIKV vaccines.

Clinical imprinting: the impact of early clinical learning on career long professional development in nursing.

PubMed

Andrew, Nicola

2013-05-01

The literature recognises a relationship between clinical experience and a successful undergraduate experience in nursing; however what constitutes an effective approach remains the subject of debate, particularly in relation to first year of learning. There is evidence from a biological standpoint that early experience impacts on the behavioural development of animals, described by Konrad Lorenz (1903-1989) as 'imprinting'. The concept of imprinting has resonance for nursing. In this article the importance of 'getting it right at the beginning' is explored and what, if anything, Lorenz's theory tells us about the impact of early clinical learning on subsequent professional development. Copyright © 2012 Elsevier Ltd. All rights reserved.

Embedding clinical interventions into observational studies

PubMed Central

Newman, Anne B.; Avilés-Santa, M. Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm. James; Krucoff, Mitchell; Kuller, Lewis H.; Lewis, Cora E.; Robinson, Jennifer G.; Taylor, Herman; Treviño, Roberto P.; Weintraub, William

2017-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

Transcultural Endocrinology: Adapting Type-2 Diabetes Guidelines on a Global Scale.

PubMed

Nieto-Martínez, Ramfis; González-Rivas, Juan P; Florez, Hermes; Mechanick, Jeffrey I

2016-12-01

Type-2 diabetes (T2D) needs to be prevented and treated effectively to reduce its burden and consequences. White papers, such as evidence-based clinical practice guidelines (CPG) and their more portable versions, clinical practice algorithms and clinical checklists, may improve clinical decision-making and diabetes outcomes. However, CPG are underused and poorly validated. Protocols that translate and implement these CPG are needed. This review presents the global dimension of T2D, details the importance of white papers in the transculturalization process, compares relevant international CPG, analyzes cultural variables, and summarizes translation strategies that can improve care. Specific protocols and algorithmic tools are provided. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical stakeholders’ opinions on the use of selective decontamination of the digestive tract in critically ill patients in intensive care units: an international Delphi study

PubMed Central

2013-01-01

Introduction Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic regimen that is not widely used in practice. We aimed to describe the opinions of key ‘stakeholders’ about the validity of the existing evidence base, likely consequences of implementation, relative importance of their opinions in influencing overall practice, likely barriers to implementation and perceptions of the requirement for further research to inform the decision about whether to embark on a further large randomised controlled trial. Methods This was a Delphi study informed by comprehensive framework of possible determinants of health professionals’ behaviour to study Critical Care practice in four countries. There were four key stakeholder participant groups including ICU physicians, pharmacists, clinical leads, and clinical microbiologists/ infectious disease physicians. Round one comprised participant interviews and Rounds two and three were online questionnaires using Delphi method. Results In this study, 141 participants were recruited of whom 82% were retained. Participants rated themselves as knowledgeable about SDD. Antibiotic resistance was identified as the most important issue. SDD was seen as a low clinical priority but few participants reported strong opposition. There was moderate agreement that research to date has not adequately addressed concerns about antibiotic resistance and lacks generalizability. Participants indicated equipoise with regard to benefits and harms of SDD, and indicated strong support for a further randomised trial. Conclusions Clinicians have clinical equipoise about the effectiveness of SDD. Future research requires longer follow up to assess antibiotic resistance as well as greater validity/generalizability to provide definitive answers on the effectiveness of decontamination and effects on antibiotic resistance. SDD was regarded as not being a high clinical priority, which may limit future trial participation. These results have identified that further large randomised controlled trial of SDD in critical care is both warranted and appropriate. PMID:24207137

DEVELOPING BIOMARKERS FOR MYCOTOXIN EXPOSURE AND EFFECT

USDA-ARS?s Scientific Manuscript database

The purpose of this presentation is to briefly summarize the toxicology and current state of biomarker development for commercially important mycotoxins with a focus on their potential usefulness in farm animals. Combining information about known exposure, clinical indicators and biomarkers will pro...

How large must a treatment effect be before it matters to practitioners? An estimation method and demonstration.

PubMed

Miller, William R; Manuel, Jennifer Knapp

2008-09-01

Treatment research is sometimes criticised as lacking in clinical relevance, and one potential source of this friction is a disconnection between statistical significance and what clinicians regard to be a meaningful difference in outcomes. This report demonstrates a novel methodology for estimating what substance abuse practitioners regard to be clinically important differences. To illustrate the estimation method, we surveyed 50 substance abuse treatment providers participating in the National Institute on Drug Abuse (NIDA) Clinical Trials Network. Practitioners identified thresholds for clinically meaningful differences on nine common outcome variables, indicated the size of effect that would justify their learning a new treatment method and estimated current outcomes from their services. Clinicians judged a difference between two treatments to be meaningful if outcomes were improved by about 10 - 12 points on the percentage of patients totally abstaining, arrested for driving while intoxicated, employed or having abnormal liver enzymes. A 5 percentage-point reduction in patient mortality was regarded as clinically significant. On continuous outcome measures (such as percentage of days abstinent or drinks per drinking day), practitioners judged an outcome to be significant when it doubled or halved the base rate. When a new treatment meets such criteria, practitioners were interested in learning it. Effects that are statistically significant in clinical trials may be unimpressive to practitioners. Clinicians' judgements of meaningful differences can inform the powering of clinical trials.

RU 486, the FDA and free enterprise.

PubMed

Buc, N L

1992-01-01

The legal question whether RU-486 can meet the standards for US Food and Drug Administration (FDA) approval for a drug indicated for abortion can be answered in the affirmative. Under the Food, Drug, and Cosmetic Act, efficacy must be demonstrated by evidence consisting of adequate and well-controlled investigations to show that a drug is safe and effective for its intended use. The FDA will approve it if on the basis of the clinical trials it could be concluded that the drug will have the effect it purports as prescribed in the labeling, and if the drug is safe. In congressional hearings and in the newspapers the so-called import alert issued by the FDA to prevent the importing of RU-486 under certain circumstances has been publicized. The import alert is no bar to conducting clinical studies in the US under an investigational new drug application (IND) nor is the import alert a bar to the filing and the pursuit of a new drug application (NDA) to allow marketing in the US. The import alert is no bar to anything except importation without an IND or NDA. The real problem is that there is no seller of RU-486 in the US and no sponsor of an NDA offering clinical evidence of safety and efficacy as well as the ability to manufacture the drug and the necessary prostaglandins properly. In additions to abortion, other uses of RU-486 include contraception, breast cancer, and Cushing syndrome. Some limited research could be done under INDs with small supplies of the drug obtained elsewhere on the world market. There are only 2 solutions to this problem. One is that Roussel must change its mind or have its mind changed as the example of the AIDS community showed, which has managed to induce the development of drugs that were impossible 8 or 10 years ago. The other solution is to found a pharmaceutical company that could induce competition for manufacturing RU-486.

Thyroid Hormone Receptor Antagonists: From Environmental Pollution to Novel Small Molecules.

PubMed

Mackenzie, Louise S

2018-01-01

Thyroid hormone receptors (TRs) are nuclear receptors which control transcription, and thereby have effects in all cells within the body. TRs are an important regulator in many basic physiological processes including development, growth, metabolism, and cardiac function. The hyperthyroid condition results from an over production of thyroid hormones resulting in a continual stimulation of thyroid receptors which is detrimental for the patient. Therapies for hyperthyroidism are available, but there is a need for new small molecules that act as TR antagonists to treat hyperthyroidism. Many compounds exhibit TR antagonism and are considered detrimental to health. Some drugs in the clinic (most importantly, amiodarone) and environmental pollution exhibit TR antagonist properties and thus have the potential to induce hypothyroidism in some people. This chapter provides an overview of novel small molecules that have been specifically designed or screened for their TR antagonist activity as novel treatments for hyperthyroidism. While novel compounds have been identified, to date none have been developed sufficiently to enter clinical trials. Furthermore, a discussion on other sources of TR antagonists is discussed in terms of side effects of current drugs in the clinic as well as environmental pollution. © 2018 Elsevier Inc. All rights reserved.

Structural Analysis of the Tobramycin and Gentamicin Clinical Resistome Reveals Limitations for Next-generation Aminoglycoside Design.

PubMed

Bassenden, Angelia V; Rodionov, Dmitry; Shi, Kun; Berghuis, Albert M

2016-05-20

Widespread use and misuse of antibiotics has allowed for the selection of resistant bacteria capable of avoiding the effects of antibiotics. The primary mechanism for resistance to aminoglycosides, a broad-spectrum class of antibiotics, is through covalent enzymatic modification of the drug, waning their bactericidal effect. Tobramycin and gentamicin are two medically important aminoglycosides targeted by several different resistance factors, including aminoglycoside 2″-nucleotidyltransferase [ANT(2″)], the primary cause of aminoglycoside resistance in North America. We describe here two crystal structures of ANT(2″), each in complex with AMPCPP, Mn(2+), and either tobramycin or gentamicin. Together these structures outline ANT(2″)'s specificity for clinically used substrates. Importantly, these structures complete our structural knowledge for the set of enzymes that most frequently confer clinically observed resistance to tobramycin and gentamicin. Comparison of tobramycin and gentamicin binding to enzymes in this resistome, as well as to the intended target, the bacterial ribosome, reveals surprising diversity in observed drug-target interactions. Analysis of the diverse binding modes informs that there are limited opportunities for developing aminoglycoside analogs capable of evading resistance.

Adverse effects of anticancer agents that target the VEGF pathway.

PubMed

Chen, Helen X; Cleck, Jessica N

2009-08-01

Antiangiogenesis agents that target the VEGF/VEGF receptor pathway have become an important part of standard therapy in multiple cancer indications. With expanded clinical experience with this class of agents has come the increasing recognition of the diverse adverse effects related to disturbance of VEGF-dependent physiological functions and homeostasis in the cardiovascular and renal systems, as well as wound healing and tissue repair. Although most adverse effects of VEGF inhibitors are modest and manageable, some are associated with serious and life-threatening consequences, particularly in high-risk patients and in certain clinical settings. This Review examines the toxicity profiles of anti-VEGF antibodies and small-molecule inhibitors. The potential mechanisms of the adverse effects, risk factors, and the implications for selection of patients and management are discussed.

Technical pre-analytical effects on the clinical biochemistry of Atlantic salmon (Salmo salar L.).

PubMed

Braceland, M; Houston, K; Ashby, A; Matthews, C; Haining, H; Rodger, H; Eckersall, P D

2017-01-01

Clinical biochemistry has long been utilized in human and veterinary medicine as a vital diagnostic tool, but despite occasional studies showing its usefulness in monitoring health status in Atlantic salmon (Salmo salar L.), it has not yet been widely utilized within the aquaculture industry. This is due, in part, to a lack of an agreed protocol for collection and processing of blood prior to analysis. Moreover, while the analytical phase of clinical biochemistry is well controlled, there is a growing understanding that technical pre-analytical variables can influence analyte concentrations or activities. In addition, post-analytical interpretation of treatment effects is variable in the literature, thus making the true effect of sample treatment hard to evaluate. Therefore, a number of pre-analytical treatments have been investigated to examine their effect on analyte concentrations and activities. In addition, reference ranges for salmon plasma biochemical analytes have been established to inform veterinary practitioners and the aquaculture industry of the importance of clinical biochemistry in health and disease monitoring. Furthermore, a standardized protocol for blood collection has been proposed. © 2016 The Authors Journal of Fish Diseases Published by John Wiley & Sons Ltd.

European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries.

PubMed

Kleiboer, Annet; Smit, Jan; Bosmans, Judith; Ruwaard, Jeroen; Andersson, Gerhard; Topooco, Naira; Berger, Thomas; Krieger, Tobias; Botella, Cristina; Baños, Rosa; Chevreul, Karine; Araya, Ricardo; Cerga-Pashoja, Arlinda; Cieślak, Roman; Rogala, Anna; Vis, Christiaan; Draisma, Stasja; van Schaik, Anneke; Kemmeren, Lise; Ebert, David; Berking, Matthias; Funk, Burkhardt; Cuijpers, Pim; Riper, Heleen

2016-08-03

Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015.

Incidence and severity of self-reported chemotherapy side effects in routine care: A prospective cohort study

PubMed Central

Haas, Marion; Viney, Rosalie; Pearson, Sallie-Anne; Haywood, Philip; Brown, Chris; Ward, Robyn

2017-01-01

Aim Chemotherapy side effects are often reported in clinical trials; however, there is little evidence about their incidence in routine clinical care. The objective of this study was to describe the frequency and severity of patient-reported chemotherapy side effects in routine care across treatment centres in Australia. Methods We conducted a prospective cohort study of individuals with breast, lung or colorectal cancer undergoing chemotherapy. Side effects were identified by patient self-report. The frequency, prevalence and incidence rates of side effects were calculated by cancer type and grade, and cumulative incidence curves for each side effect computed. Frequencies of side effects were compared between demographic subgroups using chi-squared statistics. Results Side effect data were available for 449 eligible individuals, who had a median follow-up of 5.64 months. 86% of participants reported at least one side effect during the study period and 27% reported a grade IV side effect, most commonly fatigue or dyspnoea. Fatigue was the most common side effect overall (85%), followed by diarrhoea (74%) and constipation (74%). Prevalence and incidence rates were similar across side effects and cancer types. Age was the only demographic factor associated with the incidence of side effects, with older people less likely to report side effects. Conclusion This research has produced the first Australian estimates of self-reported incidence of chemotherapy side effects in routine clinical care. Chemotherapy side effects in routine care are common, continue throughout chemotherapy and can be serious. This work confirms the importance of observational data in providing clinical practice-relevant information to decision-makers. PMID:29016607

Incidence and severity of self-reported chemotherapy side effects in routine care: A prospective cohort study.

PubMed

Pearce, Alison; Haas, Marion; Viney, Rosalie; Pearson, Sallie-Anne; Haywood, Philip; Brown, Chris; Ward, Robyn

2017-01-01

Chemotherapy side effects are often reported in clinical trials; however, there is little evidence about their incidence in routine clinical care. The objective of this study was to describe the frequency and severity of patient-reported chemotherapy side effects in routine care across treatment centres in Australia. We conducted a prospective cohort study of individuals with breast, lung or colorectal cancer undergoing chemotherapy. Side effects were identified by patient self-report. The frequency, prevalence and incidence rates of side effects were calculated by cancer type and grade, and cumulative incidence curves for each side effect computed. Frequencies of side effects were compared between demographic subgroups using chi-squared statistics. Side effect data were available for 449 eligible individuals, who had a median follow-up of 5.64 months. 86% of participants reported at least one side effect during the study period and 27% reported a grade IV side effect, most commonly fatigue or dyspnoea. Fatigue was the most common side effect overall (85%), followed by diarrhoea (74%) and constipation (74%). Prevalence and incidence rates were similar across side effects and cancer types. Age was the only demographic factor associated with the incidence of side effects, with older people less likely to report side effects. This research has produced the first Australian estimates of self-reported incidence of chemotherapy side effects in routine clinical care. Chemotherapy side effects in routine care are common, continue throughout chemotherapy and can be serious. This work confirms the importance of observational data in providing clinical practice-relevant information to decision-makers.

Clinical application of ghrelin for chronic respiratory failure.

PubMed

Matsumoto, Nobuhiro; Tsubouchi, Hironobu; Imazu, Yoshifumi; Arimura, Yasuji; Yanagi, Shigehisa; Iiboshi, Hirotoshi; Nakazato, Masamitsu

2017-01-01

Chronic respiratory failure, which is often caused by chronic obstructive pulmonary disease, chronic lower respiratory tract infection, or interstitial pneumonia, often leads to cachexia with disease progression. Patients who have chronic respiratory failure with cachexia exhibit increased morbidity. Although cachectic status is an important clinical problem, there are no effective therapies for cachexia. Ghrelin has various effects, including increasing food intake, attenuating sympathetic nerve activity, inhibiting inflammation, increasing cardiac output, and controlling fat utilization. These effects of ghrelin are ideal targets for the treatment of severely wasting chronic respiratory disease. In a few clinical studies, including a small randomized controlled trial, ghrelin administration to cachectic patients with chronic respiratory failure improved exercise tolerance, dyspnea, and appetite. The patients in these studies gained muscle mass and weight. In another study of chronic lower respiratory tract infection with cachexia, ghrelin suppressed airway inflammation by decreasing neutrophil accumulation in the airway, resulting in improvements in oxygenation and exercise tolerance. Although further clinical investigations are needed to clarify its usefulness, ghrelin is expected to become a novel therapy for cachectic patients with chronic respiratory failure.

Multiscale Modeling of Drug-induced Effects of ReDuNing Injection on Human Disease: From Drug Molecules to Clinical Symptoms of Disease

NASA Astrophysics Data System (ADS)

Luo, Fang; Gu, Jiangyong; Zhang, Xinzhuang; Chen, Lirong; Cao, Liang; Li, Na; Wang, Zhenzhong; Xiao, Wei; Xu, Xiaojie

2015-05-01

ReDuNing injection (RDN) is a patented traditional Chinese medicine, and the components of it were proven to have antiviral and important anti-inflammatory activities. Several reports showed that RDN had potential effects in the treatment of influenza and pneumonia. Though there were several experimental reports about RDN, the experimental results were not enough and complete due to that it was difficult to predict and verify the effect of RDN for a large number of human diseases. Here we employed multiscale model by integrating molecular docking, network pharmacology and the clinical symptoms information of diseases and explored the interaction mechanism of RDN on human diseases. Meanwhile, we analyzed the relation among the drug molecules, target proteins, biological pathways, human diseases and the clinical symptoms about it. Then we predicted potential active ingredients of RDN, the potential target proteins, the key pathways and related diseases. These attempts may offer several new insights to understand the pharmacological properties of RDN and provide benefit for its new clinical applications and research.

HDAC Inhibition and Graft Versus Host Disease

PubMed Central

Choi, Sung; Reddy, Pavan

2011-01-01

Histone deacetylase (HDAC) inhibitors are currently used clinically as anticancer drugs. Recent data have demonstrated that some of these drugs have potent antiinflammatory or immunomodulatory effects at noncytotoxic doses. The immunomodulatory effects have shown potential for therapeutic benefit after allogeneic bone marrow transplantation in several experimental models of graft versus host disease (GVHD). These effects, at least in part, result from the ability of HDAC inhibitors (HDACi) to suppress the function of host antigen presenting cells such as dendritic cells (DC). HDACi reduce the dendritic cell (DC) responses, in part, by enhancing the expression of indoleamine 2,3-dioxygenase (IDO) in a signal transducer and activator of transcription-3 (STAT-3) dependent manner. They also alter the function of other immune cells such as T regulatory cells and natural killer (NK) cells, which also play important roles in the biology of GVHD. Based on these observations, a clinical trial has been launched to evaluate the impact of HDAC inhibitors on clinical GVHD. The experimental, mechanistic studies along with the brief preliminary observations from the ongoing clinical trial are discussed in this review. PMID:21298214

Implementation of national comprehensive cancer network evidence-based guidelines to prevent and treat cancer-related infections.

PubMed

Wood, Sylvia K; Payne, Judith K

2012-06-01

Clinical practice guidelines are an important result of evidence-based research. However, current clinical practice remains out of step with the rapid pace of research advancements. Often, decades pass before research is translated into clinical practice. The National Comprehensive Cancer Network (NCCN) has created evidence-based clinical guidelines to promote effective clinical practice. Formerly, the NCCN established guidelines to reduce cancer-related infections only for neutropenic patients; however, they have expanded their guidelines beyond neutropenia to prevent and treat cancer-related infections. Implementing scientific evidence into clinical practice is challenging and complex, and healthcare professionals should understand barriers to implementing clinical practice guidelines to ensure successful translation into practice. This article provides a brief review of NCCN guidelines and describes common barriers encountered during implementation. In addition, a conceptual framework is offered to help identify and address potential concerns before and after adoption of guidelines.

Rheumatic effects of vibration at work

PubMed Central

Palmer, Keith T; Bovenzi, Massimo

2016-01-01

Occupational exposures to vibration come in many guises and are very common at a population level. It follows that an important minority of working-aged patients seen by medical services will have been exposed to this hazard of employment. Vibration can cause human health effects which may manifest in the patients that rheumatologists see. In this chapter we identify the health effects of relevance to them, and review their epidemiology, pathophysiology, clinical presentation, differential diagnosis, and vocational and clinical management. On either side of this, we describe the nature and assessment of the hazard, the scale and common patterns of exposure to vibration in the community, and the legal basis for controlling health risks, and comment on the role of health surveillance in detecting early adverse effects and what can be done to prevent the rheumatic effects of vibration at work. PMID:26612239

Financial impact of community-based dental education.

PubMed

Bailit, Howard L

2010-10-01

The financial impact of community-based dental education on dental school and community clinic budgets is a major issue. The evidence suggests that community experiences for dental students of fifty or more days, if effectively managed, can increase school net revenues due to the following factors: 1) the community rotations increase student productivity, approximating the loss of dental school clinical income; 2) the reallocation of unused clinical resources at the dental school reduces student clinic deficits; 3) schools and federally qualified health centers (FQHCs) that share surplus student patient revenues generate additional net income; and 4) enrollment of more students without additional new facilities and faculty increases total school tuition revenues. For FQHC dental clinics, student rotations increase the number of patients treated and may generate surplus revenues. Community-based dental education also provides schools and clinics important non-financial advantages.

Clinical importance of IL-22 cascade in IBD.

PubMed

Mizoguchi, Atsushi; Yano, Arisa; Himuro, Hidetomo; Ezaki, Yui; Sadanaga, Takayuki; Mizoguchi, Emiko

2018-04-01

IL-22 is a relatively new cytokine that is characterized by several unique biological properties. In the intestines, the effect of IL-22 is restricted mainly to non-lymphoid cells such as epithelial cells. Interestingly, the expression pattern and major cellular source of IL-22 have distinct difference between large and small intestines. IL-22 possesses an ability to constitutively activate STAT3 for promoting epithelial cell regeneration and reinforcing mucosal barrier integrity through stimulating the expression of anti-bacterial peptide and mucins. Of note, IL-22 is characterized as a two-faced cytokine that can play not only protective but also deleterious roles in the intestinal inflammation depending on the cytokine environment such as the expression levels of IL-23, T-bet, and IL-22 binding protein. Most importantly, clinical relevance of IL-22 to inflammatory bowel disease has been well highlighted. Mucosal healing, which represents the current therapeutic goal for IBD, can be induced by IL-22. Indeed, indigo naturalis, which can activate IL-22 pathway through Ahr, has been shown in a clinical trial to exhibit a strong therapeutic effect on ulcerative colitis. Despite the beneficial effect of IL-22, continuous activation of the IL-22 pathway increases the risk of colitis-associated cancer, particularly in patients with an extended history of IBD. This review article discusses how IL-22 regulates colitis, how beneficial versus deleterious effects of IL-22 is determined, and why IL-22 represents a promising target for IBD therapy.

[Effect of a self-createdquestionnaire to the history collection of patients with vertigo or dizziness].

PubMed

Li, J J; Li, Y F; Li, Q; Liu, X L; Liu, Y L; Shi, W Y; Liu, R

2018-06-05

Objective: To develop a self-designed questionnaire for history collection of patients with vertigo or dizziness, and to analyze its effect to clinical work. Method: An observational study was conducted to collect 69 patients who had undergone vestibular function tests in our department with main complaints of " dizziness and dizziness".Information was extracted from the questionnaires filled by patients themselves and the inpatient medical records wrote by doctors.The differences in ability to reflect clinically important information was investigated between the questionnaire and medical record. Result: Questionnaire is more comprehensive and meticulous for history collection. It is better than inpatient medical documents. It contains character of vertigo, duration, frequency of attack, time of onset, inducing and aggravating factors, relation with position and posture, concomitant symptoms, ear condition, vision, headache, conditions of other systems, consciousness, medication, VAS score of instability, previous history, personal history, family history, and positive results of examinations.It has a better detection rate in terms of vertigo frequency, duration, suspicious otolith or not, and vestibular compensation than that of inpatient medical record ( P <0.05). Conclusion: This self-designed questionnaire can help doctors to collect medical history of patients with vertigo or dizziness.It is worthy of clinical promotion as an important supplement for inpatient and outpatient medical records. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

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

PubMed Central

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

2012-01-01

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

Pleiotropic effects of statins on the treatment of chronic periodontitis--a systematic review.

PubMed

Estanislau, Ilanna Mara Gomes; Terceiro, Icrólio Ribeiro Colares; Lisboa, Mario Roberto Pontes; Teles, Patrícia de Barros; Carvalho, Rosimary de Sousa; Martins, Ricardo Souza; Moreira, Maria Mônica Studart Mendes

2015-06-01

Statins are inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase and are an important group of hypolipidaemic drugs, widely used in the treatment of hypercholesterolaemia and cardiovascular disease. Some studies have shown that statins are able to modulate inflammation and alveolar bone loss. In order to evaluate whether statins could influence periodontal treatment, improving the clinical and radiographic parameters in chronic periodontitis, a systematic review was conducted in the databases PUBMED and BIREME, searching for articles in English and Portuguese, published between the years 2004 and 2014, using the combined keywords statin, periodontal disease, periodontitis and alveolar bone. Studies regarding the treatment of chronic periodontitis in humans, blind or double-blind, retrospective cohort or randomized controlled trials that used statins topically or systemically were selected. Statins have important anti-inflammatory and immune effects, reducing levels of C-reactive protein and matrix metalloproteinases and their intermediate products, such as tumour necrosis factor-α, and are also able to inhibit the adhesion and extravasation of leukocytes, which block the co-stimulation of T cells. Statins reduce bone resorption by inhibiting osteoclast formation and lead to increased apoptosis of these cells. The effect of statins on bone formation is related to the increased gene expression of bone morphogenetic protein in osteoblasts. Although we found biological mechanisms and clinical results that show lower alveolar bone loss and reduction of clinical signs of inflammation, further studies are needed to evaluate the clinical applicability of statins in the routine treatment of chronic periodontitis. © 2014 The British Pharmacological Society.

Metabolomic responses to lumacaftor/ivacaftor in cystic fibrosis.

PubMed

Kopp, Benjamin T; McCulloch, Scott; Shrestha, Chandra L; Zhang, Shuzhong; Sarzynski, Lisa; Woodley, Frederick W; Hayes, Don

2018-05-01

Cystic fibrosis (CF) is a life-limiting disease caused by a defect in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Lumacaftor/Ivacaftor is a novel CFTR modulator approved for patients that are homozygous for Phe508del CFTR, but its clinical effectiveness varies amongst patients, making it difficult to determine clinical responders. Therefore, identifying biochemical biomarkers associated with drug response are clinically important for follow-up studies. Serum metabolomics was performed on twenty patients with CF pre- and 6-month post-Lumacaftor/Ivacaftor response via Ultrahigh Performance Liquid Chromatography-Tandem Mass Spectroscopy (UPLC-MS/MS). Correlation with clinical variables was performed. Metabolomics analysis demonstrated 188 differentially regulated metabolites between patients pre- and post-Lumacaftor/Ivacaftor initiation, with a predominance of lipid and amino acid alterations. The top 30 metabolites were able to differentiate pre- and post-Lumacaftor/Ivacaftor status in greater than 90% of patients via a random-forest confusion matrix. Alterations in bile acids, phospholipids, and bacteria-associated metabolites were the predominant changes associated with drug response. Importantly, changes in metabolic patterns were associated with clinical responders. Selected key lipid and amino acid metabolic pathways were significantly affected by Lumacaftor/Ivacaftor initiation and similar pathways were affected in clinical responders. Targeted metabolomics may provide useful and relevant biomarkers of CFTR modulator responses. © 2018 Wiley Periodicals, Inc.

The role of the nurse teacher in clinical practice: an empirical study of Finnish student nurse experiences.

PubMed

Saarikoski, Mikko; Warne, Tony; Kaila, Päivi; Leino-Kilpi, Helena

2009-08-01

This paper focuses on the role of the nurse teacher (NT) in supporting student nurse education in clinical practice. The paper draws on the outcomes of a study aimed at exploring student nurse experiences of the pedagogical relationship with NTs during their clinical placements. The participants (N=549) were student nurses studying on pre-registration nursing programmes in Finland. Data were analysed using descriptive statistics, cross-tabulation and ANOVA. The study showed that the core aspect of NTs work in clinical practice revolved around the relationship between student, mentor and NT. Higher levels of satisfaction were experienced in direct proportion to the number of meetings held between the student and NT. However, whilst the importance of this relationship has been reported elsewhere, an additional aspect of this relationship emerged in the data analysis. Those NT who facilitated good face to face contact also used other methods to enhance the relationship, particularly e-mail, virtual learning environment and texting. This outcome suggests that NT's interpersonal and communicative skills are as important as their clinical knowledge and skills in promoting effective learning in the clinical practice area. The paper argues for such approaches to be utilised within the emergent opportunities afforded by new communication and educational technologies.

Medications Development for the Treatment of Alcohol Use Disorder: Insights into the Predictive Value of Animal and Human Laboratory Models

PubMed Central

Yardley, Megan M.; Ray, Lara A.

2016-01-01

Development of effective treatments for alcohol use disorder (AUD) represents an important public health goal. This review provides a summary of completed preclinical and clinical studies testing pharmacotherapies for treatment of AUD. We discuss opportunities for improving the translation from preclinical findings to clinical trial outcomes, focusing on the validity and predictive value of animal and human laboratory models of AUD. Specifically, while preclinical studies of medications development have offered important insights into the neurobiology of the disorder and alcohol's molecular targets, limitations include the lack of standardized methods and streamlined processes whereby animal studies can readily inform human studies. Behavioral pharmacology studies provide a less expensive and valuable opportunity to assess the feasibility of a pharmacotherapy prior to initiating larger scale clinical trials by providing insights into the mechanism of the drug, which can then inform recruitment, analyses, and assessments. Summary tables are provided to illustrate the wide range of preclinical, human laboratory, and clinical studies of medications development for alcoholism. Taken together, this review highlights the challenges associated with animal paradigms, human laboratory studies and clinical trials with the overarching goal of advancing treatment development and highlighting opportunities to bridge the gap between preclinical and clinical research. PMID:26833803

Working memory, reasoning, and expertise in medicine-insights into their relationship using functional neuroimaging.

PubMed

Hruska, Pam; Krigolson, Olav; Coderre, Sylvain; McLaughlin, Kevin; Cortese, Filomeno; Doig, Christopher; Beran, Tanya; Wright, Bruce; Hecker, Kent G

2016-12-01

Clinical reasoning is dependent upon working memory (WM). More precisely, during the clinical reasoning process stored information within long-term memory is brought into WM to facilitate the internal deliberation that affords a clinician the ability to reason through a case. In the present study, we examined the relationship between clinical reasoning and WM while participants read clinical cases with functional magnetic resonance imaging (fMRI). More specifically, we examined the impact of clinical case difficulty (easy, hard) and clinician level of expertise (2nd year medical students, senior gastroenterologists) on neural activity within regions of cortex associated with WM (i.e., the prefrontal cortex) during the reasoning process. fMRI was used to scan ten second-year medical students and ten practicing gastroenterologists while they reasoned through sixteen clinical cases [eight straight forward (easy) and eight complex (hard)] during a single 1-h scanning session. Within-group analyses contrasted the easy and hard cases which were then subsequently utilized for a between-group analysis to examine effects of expertise (novice > expert, expert > novice). Reading clinical cases evoked multiple neural activations in occipital, prefrontal, parietal, and temporal cortical regions in both groups. Importantly, increased activation in the prefrontal cortex in novices for both easy and hard clinical cases suggests novices utilize WM more so than experts during clinical reasoning. We found that clinician level of expertise elicited differential activation of regions of the human prefrontal cortex associated with WM during clinical reasoning. This suggests there is an important relationship between clinical reasoning and human WM. As such, we suggest future models of clinical reasoning take into account that the use of WM is not consistent throughout all clinical reasoning tasks, and that memory structure may be utilized differently based on level of expertise.

[Decision aids in complex polypharmacy : Medication data bases and counselling by clinical pharmacists].

PubMed

Weinrebe, W; Preda, R; Bischoff, S; Nussbickel, D; Humm, M; Jeckelmann, K; Goetz, S

2017-07-18

The number of older people with polypharmacy (more than six drugs taken simultaneously) is increasing. The greatest proportion consists of guideline drugs, analgesics and psychopharmaceuticals because in many cases of geriatric multimorbidity several underlying main diseases are present which must be treated according to the guidelines. Polypharmacy is a complex and difficult situation for all treating physicians because substantial side effects and intoxication can be induced but it can also be very difficult to recognize which drug was at fault and how a reduction can be safely made. This article describes the exemplary case of a 77-year-old patient with drug-induced delirium and demonstrates the procedure followed. The question of rapid assistance by the utilization of medication data bases is described and the importance of clinical pharmacists is demonstrated. In the future working with medication data bases will possibly become increasingly more important for physicians and hopefully simpler. The case presented here also shows that the effective and justified reduction of drugs can show a very good effect and is possible.

Beyond "getting drugs into bodies": social science perspectives on pre-exposure prophylaxis for HIV.

PubMed

Auerbach, Judith D; Hoppe, Trevor A

2015-01-01

Social scientists have much to contribute to the analysis of the real and potential contribution of pre-exposure prophylaxis (PrEP) to HIV prevention around the world. Beyond just a matter of clinical efficacy and getting pills into people's mouths, PrEP raises a number of important social-psychological questions that must be attended to in order to translate biomedical and clinical findings into uptake of PrEP among enough people at risk of HIV infection to produce population-level effectiveness. PrEP is a dynamic phenomenon with "dialectical" attributes that invite both optimism and cynicism as a desirable and effective HIV prevention strategy. PrEP disrupts traditional notions of "safe" and "unsafe" sex; it confers on its users a level of agency and control not generally achieved with condoms; and it affects sexual practices and sexual cultures in meaningful ways. As these dynamics play out in different contexts, and as new modes of PrEP administration emerge, it will be important for social scientists to be engaged in assessing their impact on PrEP implementation and effectiveness.

Evaluation of the impact of urban pollution on the quality of skin: a multicentre study in Mexico.

PubMed

Lefebvre, M-A; Pham, D-M; Boussouira, B; Bernard, D; Camus, C; Nguyen, Q-L

2015-06-01

After pilot and preliminary studies aimed at identifying pertinent biochemical parameters, a multicenter clinical study was performed to evaluate the effect of pollution on human skin. The clinical study was performed in collaboration with the 'Centre Régional de lutte contre le cancer de Montpellier' and the 'National Institute of Public Health of Mexico' on 96 subjects in Mexico City (exposed to pollution) and 93 subjects in Cuernavaca (less exposed to pollution). Both biochemical and clinical skin parameters were studied. The study demonstrated significant quantitative and qualitative modifications of parameters related to sebum excretion in Mexico City compared to Cuernavaca one: An increased level of sebum excretion rate, a lower level of vitamin E and squalene in sebum, an increase of lactic acid and a higher erythematous index on the face of the subjects. In the stratum corneum, a significant higher level of carbonylated proteins and a lower level of IL 1α were noticed, as well as a decrease of ATP concentration with a decrease of chymotrysin like activity, without modifications of corneodesmosin content and trypsin like activity. From a clinical point of view, a higher frequency of atopic and urticarial skins, a higher frequency of red dermographism, an important seborrheic status at the forehead level and a lower level of dandruffs were noted in Mexico City population. The analysis taking into account the sex does not modify the observed results. The study demonstrated an important impact of polluted environmental conditions on skin quality, evidencing important modifications of superficial biochemical parameters. The cause/effects relationships of these modifications remain, however, to be further assessed by a complementary in vitro/in vivo approaches. © 2015 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

Comparative Effect of Contrast Media Type on the Incidence of Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

PubMed

Eng, John; Wilson, Renee F; Subramaniam, Rathan M; Zhang, Allen; Suarez-Cuervo, Catalina; Turban, Sharon; Choi, Michael J; Sherrod, Cheryl; Hutfless, Susan; Iyoha, Emmanuel E; Bass, Eric B

2016-03-15

Iodine contrast media are essential components of many imaging procedures. An important potential side effect is contrast-induced nephropathy (CIN). To compare CIN risk for contrast media within and between osmolality classes in patients receiving diagnostic or therapeutic imaging procedures. PubMed, EMBASE, Cochrane Library, Clinical Trials.gov, and Scopus through June 2015. Randomized, controlled trials that reported CIN-related outcomes in patients receiving low-osmolar contrast media (LOCM) or iso-osmolar contrast media for imaging. Independent study selection and quality assessment by 2 reviewers and dual extraction of study characteristics and results. None of the 5 studies that compared types of LOCM reported a statistically significant or clinically important difference among study groups, but the strength of evidence was low. Twenty-five randomized, controlled trials found a slight reduction in CIN risk with the iso-osmolar contrast media agent iodixanol compared with a diverse group of LOCM that just reached statistical significance in a meta-analysis (pooled relative risk, 0.80 [95% CI, 0.65 to 0.99]; P = 0.045). This comparison's strength of evidence was moderate. In a meta regression of randomized, controlled trials of iodixanol, no relationship was found between route of administration and comparative CIN risk. Few studies compared LOCM. Procedural details about contrast administration were not uniformly reported. Few studies specified clinical indications or severity of baseline renal impairment. No differences were found in CIN risk among types of LOCM. Iodixanol had a slightly lower risk for CIN than LOCM, but the lower risk did not exceed a criterion for clinical importance. Agency for Healthcare Research and Quality.

Does frenotomy improve breast-feeding difficulties in infants with ankyloglossia?

PubMed

Ito, Yasuo

2014-08-01

The aim of this systematic review was to critically examine the existing literature regarding the effectiveness of tongue-tie division in infants with ankyloglossia, using the new grades of recommendations, assessment, development, and evaluation (GRADE) rating system. A clinical question was structured according to patient, intervention, comparison, and outcome, as follows: in infants with poor breast-feeding and ankyloglossia (patient), does frenotomy (intervention), compared to lactation support alone (comparison), improve feeding (outcome)? An electronic literature search was systematically conducted from databases including PubMed, Japana Centra Revuo Medicina (Igaku Chuo Zasshi), CINAHL, and Cochrane Library using the key words "ankyloglossia," "tongue-tie," "frenotomy," and/or "breast-feeding" in English and equivalent terms in Japanese. The literature search yielded four randomized clinical trials, and 12 observational studies for analysis. The quality of the literature was rated in regard to the two most important outcomes (sucking/latching, and nipple pain) and five less important outcomes (milk supply/milk production, continuation of breast-feeding, weight gain, adverse events, and dyad distress) in accordance with the GRADE system. Evidence levels of the most important outcomes were rated either A (strong evidence) or B (moderate evidence), and less important outcomes were rated C (weak evidence); every outcome consistently showed a favorable effect of frenotomy on breast-feeding. The literature review supported an overall moderate quality of evidence for the effectiveness of frenotomy for the treatment of breast-feeding difficulties in infants with ankyloglossia. No major complications from frenotomy were reported. © 2014 Japan Pediatric Society.

77 FR 72409 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

... Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on October 16, 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... import the listed controlled substance for analytical research and clinical trials. The import of the...

An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies

PubMed Central

Iffland, Kerstin; Grotenhermen, Franjo

2017-01-01

Abstract Introduction: This literature survey aims to extend the comprehensive survey performed by Bergamaschi et al. in 2011 on cannabidiol (CBD) safety and side effects. Apart from updating the literature, this article focuses on clinical studies and CBD potential interactions with other drugs. Results: In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epilepsy and psychotic disorders. Here, the most commonly reported side effects were tiredness, diarrhea, and changes of appetite/weight. In comparison with other drugs, used for the treatment of these medical conditions, CBD has a better side effect profile. This could improve patients' compliance and adherence to treatment. CBD is often used as adjunct therapy. Therefore, more clinical research is warranted on CBD action on hepatic enzymes, drug transporters, and interactions with other drugs and to see if this mainly leads to positive or negative effects, for example, reducing the needed clobazam doses in epilepsy and therefore clobazam's side effects. Conclusion: This review also illustrates that some important toxicological parameters are yet to be studied, for example, if CBD has an effect on hormones. Additionally, more clinical trials with a greater number of participants and longer chronic CBD administration are still lacking. PMID:28861514

Individual variability in clinical effect and tolerability of opioid analgesics - Importance of drug interactions and pharmacogenetics.

PubMed

Solhaug, Vigdis; Molden, Espen

2017-10-01

As pain is often a comorbid condition, many patients use opioid analgesics in combination with several other drugs. This implies a generally increased risk of drug interactions, which along with inherent pharmacogenetic variability and other factors may cause differences in therapeutic response of opioids. To provide an overview of interactions and pharmacogenetic variability of relevance for individual differences in effect and tolerability of opioid analgesics, which physicians and other healthcare professionals should be aware of in clinical practice. The article was based on unsystematic searches in PubMed to identify literature highlighting the clinical impact of drug interactions and pharmacogenetics as sources of variable response of opioid analgesics. Cytochrome P450 (CYP)-mediated metabolism is an important process for both clinically relevant interactions and pharmacogenetic variability of several opioids. Concomitant use of CYP inhibitors (e.g. paroxetine, fluoxetine and bupropion) or inducers (e.g. carbamazepine, phenobarbital and phenytoin) could counteract the clinical effect or trigger side effects of analgesics in the same manner as genetically determined differences in CYP2D6-mediated metabolism of many opioids. Moreover, combination treatment with drugs that inhibit or induce P-glycoprotein (ABCB1), a blood-brain barrier efflux transporter, may alter the amount ('dose') of opioids distributed to the brain. At the pharmacodynamic level, it is crucial to be aware of the potential risk of interaction causing serotonergic syndrome when combining opioids and serotonergic drugs, in particular antidepressants inhibiting serotonin reuptake (SSRIs and SNRIs). Regarding pharmacogenetics at the receptor level of pain treatment, the knowledge is currently scarce, but an allelic variant of the μ1 opioid receptor (OPRM1) gene has been associated with higher dosage requirement to achieve analgesia. Drug interactions and pharmacogenetic differences may lead to therapeutic failure or serious side effects of opioid analgesics. Many interactions involve combinations with antidepressants and antiepileptics, which are highly relevant drugs in patients suffering from pain. To prevent unfavourable drug interactions it is important that clinicians pay close attention and use electronic drug interaction checkers when treatments are initiated or discontinued. For the management of issues related to pharmacogenetic differences, blood-based CYP genotyping is available as routine test at many laboratories, and provide a valuable tool for proper choice of drugs and doses for treatment of pain and other diseases. Copyright © 2017 Scandinavian Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Importance of Building Confidence in Patient Communication and Clinical Skills Among Chiropractic Students

PubMed Central

Hecimovich, Mark D.; Volet, Simone E.

2009-01-01

Purpose: One important objective of chiropractic education is to foster student professional confidence and competence in patient communication and clinical skills. Therefore, the aim of this article is to review the extant literature on this topic, stressing the significance of building students' confidence for effective practice and the need for more research in this area. Methods: The authors reviewed MEDLINE and ERIC from 1980 through 2008 using several key words pertinent to confidence and health care. Three distinct, but interrelated, bodies of literature were assessed, including professional confidence in health care research, the nature and development of confidence in educational psychology research, and fostering professional confidence in chiropractic education. Results: It was apparent through the review that chiropractic education has developed educational methods and opportunities that may help develop and build student confidence in patient communication and clinical skills. However, there has not been sufficient research to provide empirical evidence of the impact. Conclusion: Fostering chiropractic students' development of confidence in what they say and do is of paramount importance not only to them as new practitioners but more importantly to the patient. There is no doubt that a better understanding of how confidence can be developed and consolidated during tertiary study should be a major goal of chiropractic education PMID:19826543

Counseling Self-Efficacy, Quality of Services and Knowledge of Evidence-Based Practices in School Mental Health

ERIC Educational Resources Information Center

Schiele, Bryn E.; Weist, Mark D.; Youngstrom, Eric A.; Stephan, Sharon H.; Lever, Nancy A.

2014-01-01

Counseling self-efficacy (CSE), defined as one's beliefs about his or her ability to effectively counsel a client, is an important precursor of effective clinical practice. While research has explored the association of CSE with variables such as counselor training, aptitude and level of experience, little attention has been paid to CSE among…

When you can't have the cake and eat it too: a study of medical doctors' priorities in complex choice situations.

PubMed

Carlsen, Benedicte; Hole, Arne Risa; Kolstad, Julie Riise; Norheim, Ole Frithjof

2012-12-01

Available literature provides little insight into medical doctors' prescription choices when they are required to make complex trade-offs between different concerns such as treatment effect, costs, and patient preferences simultaneously. This study investigates this issue. It is based on a Discrete Choice Experiment (DCE) conducted with 571 Norwegian doctors, where the DCE captures preferences for medications described along five dimensions important for both clinical decision-making and prioritisation in the health sector. Although effectiveness is the most important determinant of choice in our study, doctors also put considerable weight on patients' preferences and on avoiding high total costs. The probability of choosing a particular medication increases when doctors have a positive experience with the medication. GPs value high clinical effectiveness less than hospital consultants do. They are also less concerned with patient preferences. For both groups of doctors it turns out that they are willing to make difficult trade-offs between attributes they are often assumed not to be willing to compromise on, like effectiveness or patient preferences, and cost measures - given that they have proper information about these attributes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Aromatherapy and Aromatic Plants for the Treatment of Behavioural and Psychological Symptoms of Dementia in Patients with Alzheimer's Disease: Clinical Evidence and Possible Mechanisms

PubMed Central

Scuteri, Damiana; Morrone, Luigi Antonio; Rombolà, Laura; Avato, Pina Rosa; Corasaniti, Maria Tiziana; Sakurada, Shinobu; Sakurada, Tsukasa

2017-01-01

The treatment of agitation and aggression, typical Behavioural and Psychological Symptoms of Dementia (BPSDs) of Alzheimer's Disease (AD), is one of the most complicated aspects of handling patients suffering from dementia. Currently, the management of these symptoms often associated with an increased pain perception, which notably reduces the patients' quality of life (QoL), relies on the employment of antipsychotic drugs. Unfortunately, the use of these pharmacological agents has some limits: in the long term, they do not result in being equally effective as in the first weeks of treatment and they present important side effects. Therefore, there is growing interest, supported by clinical evidence, in aromatherapy for the control of agitation, aggression, and psychotic symptoms. Some molecular mechanisms have been proposed to explain the behavioural effects of essential oils, as the whole phytocomplex or the single components, but important basic research effort is still needed. For this reason, rigorous preclinical studies are necessary in order to understand the pharmacological basis of aromatherapy in the treatment of BPSDs and to widen the cluster of effective essential oils in pharmacotherapeutic practice. PMID:28465709

Towards evidence-based resuscitation of the newborn infant.

PubMed

Manley, Brett J; Owen, Louise S; Hooper, Stuart B; Jacobs, Susan E; Cheong, Jeanie L Y; Doyle, Lex W; Davis, Peter G

2017-04-22

Effective resuscitation of the newborn infant has the potential to save many lives around the world and reduce disabilities in children who survive peripartum asphyxia. In this Series paper, we highlight some of the important advances in the understanding of how best to resuscitate newborn infants, which includes monitoring techniques to guide resuscitative efforts, increasing awareness of the adverse effects of hyperoxia, delayed umbilical cord clamping, the avoidance of routine endotracheal intubation for extremely preterm infants, and therapeutic hypothermia for hypoxic-ischaemic encephalopathy. Despite the challenges of performing high-quality clinical research in the delivery room, researchers continue to refine and advance our knowledge of effective resuscitation of newborn infants through scientific experiments and clinical trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Fostering EMA's transparency policy.

PubMed

Banzi, Rita; Bertele', Vittorio; Demotes-Mainard, Jacques; Garattini, Silvio; Gluud, Christian; Kubiak, Christine; Ohmann, Christian

2014-10-01

The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also promote and develop standard practices for data sharing. The release of the EMA draft policy on publication and access to clinical trial data in 2013 has fueled a lively debate among academia, industry, and the public in general that is still ongoing. As clinical researchers and producers and users of clinical trial data, we endorse the European Medicines Agency's opening and offer a few suggestions for complete, safe, and effective data sharing. Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium†

PubMed Central

Leon, Martin B.; Piazza, Nicolo; Nikolsky, Eugenia; Blackstone, Eugene H.; Cutlip, Donald E.; Kappetein, Arie Pieter; Krucoff, Mitchell W.; Mack, Michael; Mehran, Roxana; Miller, Craig; Morel, Marie-angèle; Petersen, John; Popma, Jeffrey J.; Takkenberg, Johanna J.M.; Vahanian, Alec; van Es, Gerrit-Anne; Vranckx, Pascal; Webb, John G.; Windecker, Stephan; Serruys, Patrick W.

2011-01-01

Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Background Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. Methods and results The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended. Conclusion Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes. PMID:21216739

Methodology for Knowledge Synthesis of the Management of Vaccination Pain and Needle Fear.

PubMed

Taddio, Anna; McMurtry, C Meghan; Shah, Vibhuti; Yoon, Eugene W; Uleryk, Elizabeth; Pillai Riddell, Rebecca; Lang, Eddy; Chambers, Christine T; Noel, Melanie; MacDonald, Noni E

2015-10-01

A knowledge synthesis was undertaken to inform the development of a revised and expanded clinical practice guideline about managing vaccination pain in children to include the management of pain across the lifespan and the management of fear in individuals with high levels of needle fear. This manuscript describes the methodological details of the knowledge synthesis and presents the list of included clinical questions, critical and important outcomes, search strategy, and search strategy results. The Grading of Assessments, Recommendations, Development and Evaluation (GRADE) and Cochrane methodologies provided the general framework. The project team voted on clinical questions for inclusion and critically important and important outcomes. A broad search strategy was used to identify relevant randomized-controlled trials and quasi-randomized-controlled trials. Quality of research evidence was assessed using the Cochrane risk of bias tool and quality across studies was assessed using GRADE. Multiple measures of the same construct within studies (eg, observer-rated and parent-rated infant distress) were combined before pooling. The standardized mean difference and 95% confidence intervals (CI) or relative risk and 95% CI was used to express the effects of an intervention. Altogether, 55 clinical questions were selected for inclusion in the knowledge synthesis; 49 pertained to pain management during vaccine injections and 6 pertained to fear management in individuals with high levels of needle fear. Pain, fear, and distress were typically prioritized as critically important outcomes across clinical questions. The search strategy identified 136 relevant studies. This manuscript describes the methodological details of a knowledge synthesis about pain management during vaccination and fear management in individuals with high levels of needle fear. Subsequent manuscripts in this series will present the results for the included questions.

Importance of intellectual property generated by biomedical research at universities and academic hospitals

PubMed Central

Heus, Joris J.; de Pauw, Elmar S.; Leloux, Mirjam; Morpurgo, Margherita; Hamblin, Michael R; Heger, Michal

2017-01-01

Biomedical research has many different facets. Researchers and clinicians study disease biology and biochemistry to discover novel therapeutic targets, unravel biochemical pathways and identify biomarkers to improve diagnosis, or devise new approaches to clinically manage diseases more effectively. In all instances, the overall goal of biomedical research is to ensure that results thereof (such as a therapy, a device, or a method which may be broadly referred to as “inventions”) are clinically implemented. Most of the researchers’ efforts are centered on the advance of technical and scientific aspects of an invention. The development and implementation of an invention can be arduous and very costly. Historically, it has proven to be crucial to protect intellectual property rights (IPR) to an invention (i.e., a patent) to ensure that companies can obtain a fair return on their investment that is needed to develop an academic invention into a product for the benefit of patients. However, the importance of IPR is not generally acknowledged among researchers at academic institutions active in biomedical research. Therefore this paper aims to (1) raise IP awareness amongst clinical and translational researchers; (2) provide a concise overview of what the patenting trajectory entails; and (3) highlight the importance of patenting for research and the researcher. Importance for patients Adequate patent protection of inventions generated through biomedical research at academic institutions increases the probability that patients will benefit from these inventions, and indirectly enables the financing of clinical studies, mainly by opening up funding opportunities (e.g. specific grants aimed at start-ups, pre-seed and seed capital) that otherwise would not be accessible. As a consequence, patented inventions are more likely to become clinically tested and reach the market, providing patients with more treatment options. PMID:29623295

Glutamate Receptor Antagonists as Fast-Acting Therapeutic Alternatives for the Treatment of Depression: Ketamine and Other Compounds

PubMed Central

Niciu, Mark J.; Henter, Ioline D.; Luckenbaugh, David A.; Zarate, Carlos A.; Charney, Dennis S.

2014-01-01

The N-methyl-d-aspartate (NMDA) receptor antagonist ketamine has rapid and potent antidepressant effects in treatment-resistant major depressive disorder and bipolar depression. These effects are in direct contrast to the more modest effects seen after weeks of treatment with classic monoaminergic antidepressants. Numerous open-label and case studies similarly validate ketamine’s antidepressant properties. These clinical findings have been reverse-translated into preclinical models in an effort to elucidate ketamine’s antidepressant mechanism of action, and three important targets have been identified: mammalian target of rapamycin (mTOR), eukaryotic elongation factor 2 (eEF2), and glycogen synthase kinase-3 (GSK-3). Current clinical and preclinical research is focused on (a) prolonging/maintaining ketamine’s antidepressant effects, (b) developing more selective NMDA receptor antagonists free of ketamine’s adverse effects, and (c) identifying predictor, mediator/moderator, and treatment response biomarkers of ketamine’s antidepressant effects. PMID:24392693

The picture superiority effect in patients with Alzheimer's disease and mild cognitive impairment.

PubMed

Ally, Brandon A; Gold, Carl A; Budson, Andrew E

2009-01-01

The fact that pictures are better remembered than words has been reported in the literature for over 30 years. While this picture superiority effect has been consistently found in healthy young and older adults, no study has directly evaluated the presence of the effect in patients with Alzheimer's disease (AD) or mild cognitive impairment (MCI). Clinical observations have indicated that pictures enhance memory in these patients, suggesting that the picture superiority effect may be intact. However, several studies have reported visual processing impairments in AD and MCI patients which might diminish the picture superiority effect. Using a recognition memory paradigm, we tested memory for pictures versus words in these patients. The results showed that the picture superiority effect is intact, and that these patients showed a similar benefit to healthy controls from studying pictures compared to words. The findings are discussed in terms of visual processing and possible clinical importance.

The picture superiority effect in patients with Alzheimer’s disease and mild cognitive impairment

PubMed Central

Ally, Brandon A.; Gold, Carl A.; Budson, Andrew E.

2009-01-01

The fact that pictures are better remembered than words has been reported in the literature for over 30 years. While this picture superiority effect has been consistently found in healthy young and older adults, no study has directly evaluated the presence of the effect in patients with Alzheimer’s disease (AD) or mild cognitive impairment (MCI). Clinical observations have indicated that pictures enhance memory in these patients, suggesting that the picture superiority effect may be intact. However, several studies have reported visual processing impairments in AD and MCI patients which might diminish the picture superiority effect. Using a recognition memory paradigm, we tested memory for pictures versus words in these patients. The results showed that the picture superiority effect is intact, and that these patients showed a similar benefit to healthy controls from studying pictures compared to words. The findings are discussed in terms of visual processing and possible clinical importance. PMID:18992266

Clinical relevance of the effects of reach-to-grasp training using trunk restraint in individuals with hemiparesis poststroke: A systematic review.

PubMed

Greisberger, Andrea; Aviv, Hanna; Garbade, Sven F; Diermayr, Gudrun

2016-04-28

To evaluate the evidence for, and clinical relevance of, immediate and long-term effects of trunk restraint during reach-to-grasp training poststroke on movement patterns and functional abilities within the framework of the International Classification of Functioning, Disability and Health. PubMed, Web of Science, CINAHL, Embase, PEDro, Cochrane Library (publication dates January 1985 to March 2015). Randomized controlled trials comparing training using trunk restraint with any other exercise training. Data were extracted by one researcher and checked by two other researchers. The Cochrane Collaboration's tool for assessing risk of bias and the Physiotherapy Evidence Database scale were used by two researchers to assess study quality and risk of bias. Eight studies met the inclusion criteria. Five studies found better recovery of movement patterns (trunk displacement, elbow extension, and/or shoulder flexion - body function/structure) at post-test in the experimental compared with the control groups. Functional abilities (activity/participation) improved more in the experimental groups in 3 studies at post-test. Long-term effects were found in one study after 4 weeks. Trunk restraint has immediate and some long-term effects in adults with chronic stroke. However, these effects are not consistently clinically relevant when referring to minimal detectable change or minimal clinically important difference values.

Family physicians believe the placebo effect is therapeutic but often use real drugs as placebos.

PubMed

Kermen, Rachel; Hickner, John; Brody, Howard; Hasham, Irma

2010-10-01

Few national data exist on physicians' use of and beliefs about placebos in routine health care. We mailed a 22-question, confidential survey about placebo use and beliefs to a random sample of 1,000 members of the American Academy of Family Physicians. A total of 412 of 970 (43%) eligible physicians responded, and 56% of respondents said they had used a placebo in clinical practice. Forty percent of respondents had used an antibiotic as a placebo, and 11% had used inert substances. The most common reason for prescribing placebos was "after unjustified demand for medication." Eighty-five percent of respondents believed placebos can have both psychological and physical benefits. The majority (61%) recommended a placebo over offering no treatment, while 8% said clinical placebo use should be categorically prohibited. Nearly all respondents believed a number of routine clinical practices promote the placebo effect. Many US family physicians use placebos and generally believe the placebo effect has both psychological and physical benefits. Physicians recognize the broader application of the placebo effect but they commonly use active medication as placebos. The responses to this survey raise important questions about the appropriate use of placebos and the therapeutic value of the placebo effect in clinical practice.

A mediator effect size in randomized clinical trials.

PubMed

Kraemer, Helena Chmura

2014-12-01

To understand the process by which a treatment (T) achieves an effect on outcome (O) and thus to improve the effect of T on O, it is vital to detect mediators, to compare the impact of different mediators, and to develop hypotheses about the causal factors (all mediators) linking T and O. An index is needed to facilitate interpretation of the potential clinical importance of a mediator (M) of choice of T on treatment O in randomized clinical trials (RCTs). Ideally such a mediator effect size should (1) be invariant under any rescaling of M and O consistent with the model used, and (2) reflect the difference between the overall observed effect of T on O and what the maximal effect of T on O could be were the association between T and M broken. A mediator effect size is derived first for the traditional linear model, and then more generally for any categorical (ordered or non-ordered) potential mediator. Issues such as the problem of multiple treatments, outcomes and mediators, and of causal inferences, and the correspondence between this approach and earlier ones, are discussed. Illustrations are given of the application of the approach. Copyright © 2014 John Wiley & Sons, Ltd.

Current and future challenges in the development of antimicrobial agents.

PubMed

Rennie, Robert P

2012-01-01

Micro-organisms exist to survive. Even in the absence of antimicrobial agents, many have determinants of resistance that may be expressed phenotypically, should the need arise. With the advent of the antibiotic age, as more and more drugs were developed to treat serious infections, micro-organisms (particularly bacteria) rapidly developed resistance determinants to prevent their own demise.The most important determinants of resistance have been in the Gram-positive and Gram-negative bacteria. Among Gram-positive bacteria, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and penicillin-resistant Streptococcus pneumoniae (PRSP) have taxed researchers and pharmaceutical companies to develop new agents that are effective against these resistant strains. Among the Gram-negative bacteria, extended-spectrum beta-lactamase (ESBL) enzymes, carbapenemases (CREs) and the so-called amp-C enzymes that may be readily transferred between species of enterobacteriaceae and other facultative species have created multi-drug resistant organisms that are difficult to treat. Other resistance determinants have been seen in other clinically important bacterial species such as Neisseria gonorrhoeae, Clostridium difficile, Haemophilus influenzae and Mycobacterium tuberculosis. These issues have now spread to fungal agents of infection.A variety of modalities have been used to stem the tide of resistance. These include the development of niche compounds that target specific resistance determinants. Other approaches have been to find new targets for antimicrobial activity, use of combination agents that are effective against more than one target in the cell, or new delivery mechanism to maximize the concentration of antimicrobial agents at the site of infection without causing toxicity to the host. It is important that such new modalities have been proved effective for clinical therapy. Animal models and non-mammalian systems have been developed to determine if new agents will reach sufficient concentrations at infection sites to predict clinical efficacy without toxicity. It will also be key to consider antimicrobial stewardship as an important component of the continuing battle to prevent the development of antimicrobial resistance.

Translating research findings to clinical nursing practice.

PubMed

Curtis, Kate; Fry, Margaret; Shaban, Ramon Z; Considine, Julie

2017-03-01

To describe the importance of, and methods for, successfully conducting and translating research into clinical practice. There is universal acknowledgement that the clinical care provided to individuals should be informed on the best available evidence. Knowledge and evidence derived from robust scholarly methods should drive our clinical practice, decisions and change to improve the way we deliver care. Translating research evidence to clinical practice is essential to safe, transparent, effective and efficient healthcare provision and meeting the expectations of patients, families and society. Despite its importance, translating research into clinical practice is challenging. There are more nurses in the frontline of health care than any other healthcare profession. As such, nurse-led research is increasingly recognised as a critical pathway to practical and effective ways of improving patient outcomes. However, there are well-established barriers to the conduct and translation of research evidence into practice. This clinical practice discussion paper interprets the knowledge translation literature for clinicians interested in translating research into practice. This paper is informed by the scientific literature around knowledge translation, implementation science and clinician behaviour change, and presented from the nurse clinician perspective. We provide practical, evidence-informed suggestions to overcome the barriers and facilitate enablers of knowledge translation. Examples of nurse-led research incorporating the principles of knowledge translation in their study design that have resulted in improvements in patient outcomes are presented in conjunction with supporting evidence. Translation should be considered in research design, including the end users and an evaluation of the research implementation. The success of research implementation in health care is dependent on clinician/consumer behaviour change and it is critical that implementation strategy includes this. Translating best research evidence can make for a more transparent and sustainable healthcare service, to which nurses are central. © 2016 The Authors. Journal of Clinical Nursing Published by John Wiley & Sons Ltd.

Studies demonstrate modified T cells effective in treating blood-borne cancers

Cancer.gov

At the 2013 American Society of Hematology meeting in Dec. 2013, James Kochenderfer, M.D., NCI, presented findings from two clinical trials evaluating the use of genetically modified immune system T cells as cancer therapy. These reports represent import

Thyroid Hormone Disruption Effects Lamination of the Neocortex but not the Cerebellum in a Model of Developmental Hypothyroidism and Hypothyroxinemia

EPA Science Inventory

Introduction: Research on neurodevelopmental changes resulting from thyroid hormone (TH) disruption has important basic and clinical implications. We previously demonstrated, in a rodent model, that developmental hypothyroidism or hypothyroxinemia can cause ...

Interferon-Lambda: A Potent Regulator of Intestinal Viral Infections.

PubMed

Lee, Sanghyun; Baldridge, Megan T

2017-01-01

Interferon-lambda (IFN-λ) is a recently described cytokine found to be of critical importance in innate immune regulation of intestinal viruses. Endogenous IFN-λ has potent antiviral effects and has been shown to control multiple intestinal viruses and may represent a factor that contributes to human variability in response to infection. Importantly, recombinant IFN-λ has therapeutic potential against enteric viral infections, many of which lack other effective treatments. In this mini-review, we describe recent advances regarding IFN-λ-mediated regulation of enteric viruses with important clinical relevance including rotavirus, reovirus, and norovirus. We also briefly discuss IFN-λ interactions with other cytokines important in the intestine, and how IFN-λ may play a role in regulation of intestinal viruses by the commensal microbiome. Finally, we indicate currently outstanding questions regarding IFN-λ control of enteric infections that remain to be explored to enhance our understanding of this important immune molecule.

Interferon-Lambda: A Potent Regulator of Intestinal Viral Infections

PubMed Central

Lee, Sanghyun; Baldridge, Megan T.

2017-01-01

Interferon-lambda (IFN-λ) is a recently described cytokine found to be of critical importance in innate immune regulation of intestinal viruses. Endogenous IFN-λ has potent antiviral effects and has been shown to control multiple intestinal viruses and may represent a factor that contributes to human variability in response to infection. Importantly, recombinant IFN-λ has therapeutic potential against enteric viral infections, many of which lack other effective treatments. In this mini-review, we describe recent advances regarding IFN-λ-mediated regulation of enteric viruses with important clinical relevance including rotavirus, reovirus, and norovirus. We also briefly discuss IFN-λ interactions with other cytokines important in the intestine, and how IFN-λ may play a role in regulation of intestinal viruses by the commensal microbiome. Finally, we indicate currently outstanding questions regarding IFN-λ control of enteric infections that remain to be explored to enhance our understanding of this important immune molecule. PMID:28713375

The weak relationship between anatomy competence and clinical skills in junior medical students.

PubMed

Schoeman, Scarpa; Chandratilake, Madawa

2012-01-01

In modern curricula, the early integration of anatomy and clinical skills education at undergraduate level is seen as important. However, the direct relationship between medical students' competence in anatomy, and their clinical proficiency during early undergraduate years, has scarcely been studied. In this study, the marks for anatomy and clinical skills of three consecutive cohorts of medical students (n = 538 in total) during their first two years were correlated. The anatomy competence was measured using a new marker, the Anatomy Competence Score (ACS) which was calculated with equal contributions from theory knowledge and its practical and clinical application. Proficiency in clinical skills was determined by OSCE performance marks for stations which examined physical examination and practical procedural skills. The possible compounding effect of students' general academic ability was investigated by using the overall performance mark for each student based on their performance in all subjects over the first two years of the medical curriculum. We found that the correlation between anatomy and clinical skills marks was weak to moderate. However, this correlation was virtually nullified once the effect of academic ability was accounted for. Although these findings suggest that anatomy education does not compliment early clinical education, the lack of complexity of clinical problems used in clinical skills assessments (OSCEs) during the early stages may well be the primary contributing factor to this finding. Copyright © 2012 American Association of Anatomists.

Methodologic Guide for Evaluating Clinical Performance and Effect of Artificial Intelligence Technology for Medical Diagnosis and Prediction.

PubMed

Park, Seong Ho; Han, Kyunghwa

2018-03-01

The use of artificial intelligence in medicine is currently an issue of great interest, especially with regard to the diagnostic or predictive analysis of medical images. Adoption of an artificial intelligence tool in clinical practice requires careful confirmation of its clinical utility. Herein, the authors explain key methodology points involved in a clinical evaluation of artificial intelligence technology for use in medicine, especially high-dimensional or overparameterized diagnostic or predictive models in which artificial deep neural networks are used, mainly from the standpoints of clinical epidemiology and biostatistics. First, statistical methods for assessing the discrimination and calibration performances of a diagnostic or predictive model are summarized. Next, the effects of disease manifestation spectrum and disease prevalence on the performance results are explained, followed by a discussion of the difference between evaluating the performance with use of internal and external datasets, the importance of using an adequate external dataset obtained from a well-defined clinical cohort to avoid overestimating the clinical performance as a result of overfitting in high-dimensional or overparameterized classification model and spectrum bias, and the essentials for achieving a more robust clinical evaluation. Finally, the authors review the role of clinical trials and observational outcome studies for ultimate clinical verification of diagnostic or predictive artificial intelligence tools through patient outcomes, beyond performance metrics, and how to design such studies. © RSNA, 2018.

Effects of vedolizumab on health-related quality of life in patients with ulcerative colitis: results from the randomised GEMINI 1 trial.

PubMed

Feagan, B G; Patel, H; Colombel, J-F; Rubin, D T; James, A; Mody, R; Lasch, K

2017-01-01

Health-related quality of life (HRQL) is often diminished in patients with ulcerative colitis. To evaluate the effects of vedolizumab on HRQL in patients with ulcerative colitis. Using maintenance phase data from the GEMINI 1 study, an analysis of covariance model was used to calculate mean differences between the vedolizumab and placebo groups in changes from baseline to week 52 for 3 HRQL instruments: The Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Health Survey (SF-36), and EQ-5D. Proportions of patients meeting minimal clinically important difference (MCID) thresholds for changes on these instruments were compared between treatment groups for the overall population and for clinically important subgroups. Concordance between clinical remission and remission defined using IBDQ scores was examined. Compared with placebo-treated patients, vedolizumab-treated patients had greater improvements (152-201%) in IBDQ, EQ-5D visual analogue scale (VAS), and EQ-5D utility scores. Greater proportions (6.9-19.9%) of vedolizumab-treated patients than placebo-treated patients met MCID thresholds for all the instruments. Vedolizumab-treated patients with lower baseline disease activity and those without prior tumour necrosis factor (TNF) antagonist failure had greater HRQL improvements. Among 127 patients with clinical remission based on complete Mayo Clinic scores, >80% also had IBDQ remission; >70% of the 150 patients with IBDQ remission demonstrated clinical remission. Vedolizumab therapy was associated with significant improvements in HRQL measures compared with placebo. Benefits were greater in patients with lower disease activity and no prior TNF antagonist failure. © 2016 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

The new chimaera: the industrialization of organ transplantation. International Forum for Transplant Ethics.

PubMed

Tilney, N L; Guttmann, R D; Daar, A S; Hoffenberg, R; Kennedy, I; Lock, M; Radcliffe-Richards, J; Sells, R A

2001-03-15

Clinical organ transplantation has evolved through advances in patient care in parallel with investigations in associated biologies. It has developed from a cottage industry to an important medical specialty driven increasingly by the availability of newer and more effective immunosuppressive drugs, and dependent on consistently close collaborations between university-based clinical scientists and the pharmaceutical industry. Particularly during the past decade, however, this industry has undergone striking changes, consolidating into huge multi-national corporations, each competing for patients, their doctors, and for support of the allied hospitals. Because of the growth of "Big Pharma," the relationship between academia and industry has changed. There have been many advantages to such mutually dependent interactions. A combination of university-based expertise and the specialized knowledge and resources of industry have produced important scientific gains in drug development. Commercial sponsorship of applied research has been crucial. The orchestration of multicenter controlled clinical drug trials has provided invaluable information about the effectiveness of newer agents. But there are also disadvantages of increasing concern. Indeed, the power of "Big Pharma" in many medical fields including transplantation is such that presentation of data can be delayed, adverse results withheld, and individual investigations hampered. Clinical trials may be protracted to stifle competition. Monetary considerations may transcend common sense. Several measures to enhance the clinical relationship between the pharmaceutical industry and those involved with organ transplantation are suggested, particularly the use of third party advisors in the production of clinical trials, support for more basic research and in the dissemination of results. In this way, the increasingly problematic phenomenon of commercialization of the field of transplantation can be tempered and controlled.

A core outcome set for clinical trials in acute diarrhoea.

PubMed

Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; Lo Vecchio, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania

2015-04-01

Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects. The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set. 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.

So different, yet so similar: meta-analysis and policy modeling of willingness to participate in clinical trials among Brazilians and Indians.

PubMed

Zammar, Guilherme; Meister, Henrique; Shah, Jatin; Phadtare, Amruta; Cofiel, Luciana; Pietrobon, Ricardo

2010-12-16

With the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research. We conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model. Five studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians. Our study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme.

CAG repeat testing of androgen receptor polymorphism: is this necessary for the best clinical management of hypogonadism?

PubMed

Francomano, Davide; Greco, Emanuela A; Lenzi, Andrea; Aversa, Antonio

2013-10-01

It is controversial whether or not testing the length of the androgen receptor polymorphism in clinical practice is useful for correct diagnosis and treatment of hypogonadism. To describe the molecular and clinical implications of testing the length of the androgen receptor polymorphism for treatment of hypogonadism in both male and female subjects. A systematic Medline search was conducted using several terms related to and including the terms "androgen receptor," "CAG-repeat polymorphism," "male hypogonadism," "female hypogonadism," and "neurodegenerative disease." Clinical evidence that demonstrates the importance of CAG repeat number investigation in male and female hypogonadism. A thorough review of the clinical utility of CAG repeat polymorphism investigation in men and women with hypogonadism is presented. The role of AR CAG repeat number investigation in hypogonadism (male and female) is not yet established in the clinical practice. In both sexes, a role during clinical management of hormonal replacement therapies may be hypothesized, but the CAG repeat number's relationship with the presence or absence of hypogonadal symptoms remains unclear. Pharmacogenomic investigations of the AR polymorphism may be a future option to tailor testosterone titration individually and to better identify subjects as potentially more or less responsive to treatments; also, investigation may be important to individually predict beneficial and side effects in special subpopulations, specifically, obese men and postmenopausal women. © 2013 International Society for Sexual Medicine.

Patient-specific analysis of post-operative aortic hemodynamics: a focus on thoracic endovascular repair (TEVAR)

NASA Astrophysics Data System (ADS)

Auricchio, F.; Conti, M.; Lefieux, A.; Morganti, S.; Reali, A.; Sardanelli, F.; Secchi, F.; Trimarchi, S.; Veneziani, A.

2014-10-01

The purpose of this study is to quantitatively evaluate the impact of endovascular repair on aortic hemodynamics. The study addresses the assessment of post-operative hemodynamic conditions of a real clinical case through patient-specific analysis, combining accurate medical image analysis and advanced computational fluid-dynamics (CFD). Although the main clinical concern was firstly directed to the endoluminal protrusion of the prosthesis, the CFD simulations have demonstrated that there are two other important areas where the local hemodynamics is impaired and a disturbed blood flow is present: the first one is the ostium of the subclavian artery, which is partially closed by the graft; the second one is the stenosis of the distal thoracic aorta. Besides the clinical relevance of these specific findings, this study highlights how CFD analyses allow to observe important flow effects resulting from the specific features of patient vessel geometries. Consequently, our results demonstrate the potential impact of computational biomechanics not only on the basic knowledge of physiopathology, but also on the clinical practice, thanks to a quantitative extraction of knowledge made possible by merging medical data and mathematical models.

Multidisciplinary approach to non-surgical management of inguinal disruption in a professional hockey player treated with platelet-rich plasma, manual therapy and exercise: a case report

PubMed Central

St-Onge, Eric; MacIntyre, Ian G.; Galea, Anthony M.

2015-01-01

Objective: To present the clinical management of inguinal disruption in a professional hockey player and highlight the importance of a multidisciplinary approach to diagnosis and management. Clinical Features: A professional hockey player with recurrent groin pain presented to the clinic after an acute exacerbation of pain while playing hockey. Intervention: The patient received a clinical diagnosis of inguinal disruption. Imaging revealed a tear in the rectus abdominis. Management included two platelet-rich plasma (PRP) injections to the injured tissue, and subsequent manual therapy and exercise. The patient returned to his prior level of performance in 3.5 weeks. Discussion: This case demonstrated the importance of a multidisciplinary team and the need for advanced imaging in athletes with groin pain. Summary: Research quality concerning the non-surgical management of inguinal disruption remains low. This case adds evidence that PRP, with the addition of manual therapy and exercise may serve as a relatively quick and effective non-surgical management strategy. PMID:26816415

Development and delivery of clinical pharmacology in regulatory agencies.

PubMed

Breckenridge, Alasdair

2012-06-01

Medicines regulation is based on a foundation of science, policy and judgement. It operates within several frameworks (scientific, legal and public health), which are interdependent. While safety, quality and efficacy remain the criteria by which medicines are assessed, the benefit-to-harm balance for any medicine or medical device is of paramount importance. While the regulator was hitherto the gatekeeper who allowed a medicine on to the market, payers now require, in addition, assessment of cost and clinical effectiveness before use. As regulatory frameworks develop, several changes will occur, as follows: (i) formal benefit-harm assessment will become an integral part of submission for marketing authorizations; (ii) there will be greater use of surveillance for adverse reactions to new medicines using methods other than voluntary reporting; (iii) risk management plans will become benefit-risk management plans; (iv) life-saving medicines will be approved earlier; and (v) regulation and health technology assessment will take place simultaneously. Clinical pharmacologists will play important roles in these developments. © 2012 The Author. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.

Clinical supervision in the emergency department: a critical incident study

PubMed Central

Kilroy, D A

2006-01-01

Objectives To identify the key features of effective clinical supervision in the emergency department (ED) from the perspectives of enthusiastic consultants and specialist registrars. To highlight the importance of clinical supervision within emergency medicine, and identify obstructions to its occurrence in everyday practice. Methods A critical incident study was undertaken consisting of structured interviews, conducted by telephone or in person, with 18 consultants and higher level trainees selected for their interest in supervision. Results Direct clinical supervision of key practical skills and patient management steps was considered to be of paramount importance in providing quality patient care and significantly enhancing professional confidence. The adequacy of supervision varied depending upon patient presentation. Trainees were concerned with the competence and skills of their supervisor; consultants were concerned with wider systemic constraints upon the provision of adequate supervision to juniors. Conclusions The value of supervision extends to all patient presentations in the ED. The study raised questions concerning the appropriate attitudes and qualifications for supervisors. Protected supervisory time for those with trainees is mandatory, and must be incorporated within ED consultant job planning. PMID:16439737

Pharmacogenetic studies of antidepressant response: how far from the clinic?

PubMed

Perlis, Roy H

2007-03-01

Because the US FDA has begun to focus on disclosure of pharmacogenetic testing results in applications for new drug approval and review of existing drugs (see, eg, http://www.fda.gov/OHRMS/DOCKETS/AC/05/slides/2005-4194S1_Slide-Index.htm), the application of such testing in a clinical setting is likely to increase substantially. Instead of small cohorts of patients, potentially nearly every participant in the large pivotal trials required for drug approval could help inform the future application of that drug. Psychiatry as a whole, and antidepressant prescribing ni particular, stands to benefit in the near term from the identification of newer treatment targets that may overcome some of the limitations of current therapeutics. On the other hand, despite the excitement about the rapid pace of development in psychiatric pharmacogenetics, a number of key issues remain to be addressed before these discoveries are applied in a clinical setting. Close coordination will be required between those who study treatment efficacy and effectiveness and those who study genetic variation in populations to ensure that studies yield results that have scientific importance and clinical importance as well.

The costs, resource use and cost-effectiveness of Clinical Nurse Specialist–led interventions for patients with palliative care needs: A systematic review of international evidence

PubMed Central

Salamanca-Balen, Natalia; Seymour, Jane; Caswell, Glenys; Whynes, David; Tod, Angela

2017-01-01

Background: Patients with palliative care needs do not access specialist palliative care services according to their needs. Clinical Nurse Specialists working across a variety of fields are playing an increasingly important role in the care of such patients, but there is limited knowledge of the extent to which their interventions are cost-effective. Objectives: To present results from a systematic review of the international evidence on the costs, resource use and cost-effectiveness of Clinical Nurse Specialist–led interventions for patients with palliative care needs, defined as seriously ill patients and those with advanced disease or frailty who are unlikely to be cured, recover or stabilize. Design: Systematic review following PRISMA methodology. Data sources: Medline, Embase, CINAHL and Cochrane Library up to 2015. Studies focusing on the outcomes of Clinical Nurse Specialist interventions for patients with palliative care needs, and including at least one economic outcome, were considered. The quality of studies was assessed using tools from the Joanna Briggs Institute. Results: A total of 79 papers were included: 37 randomized controlled trials, 22 quasi-experimental studies, 7 service evaluations and other studies, and 13 economic analyses. The studies included a wide variety of interventions including clinical, support and education, as well as care coordination activities. The quality of the studies varied greatly. Conclusion: Clinical Nurse Specialist interventions may be effective in reducing specific resource use such as hospitalizations/re-hospitalizations/admissions, length of stay and health care costs. There is mixed evidence regarding their cost-effectiveness. Future studies should ensure that Clinical Nurse Specialists’ roles and activities are clearly described and evaluated. PMID:28655289

Impact of postgraduate training on communication skills teaching: a controlled study.

PubMed

Junod Perron, Noelle; Nendaz, Mathieu; Louis-Simonet, Martine; Sommer, Johanna; Gut, Anne; Cerutti, Bernard; van der Vleuten, Cees P; Dolmans, Diana

2014-04-14

Observation of performance followed by feedback is the key to good teaching of communication skills in clinical practice. The fact that it occurs rarely is probably due to clinical supervisors' perceived lack of competence to identify communication skills and give effective feedback. We evaluated the impact of a faculty development programme on communication skills teaching on clinical supervisors' ability to identify residents' good and poor communication skills and to discuss them interactively during feedback. We conducted a pre-post controlled study in which clinical supervisors took part to a faculty development program on teaching communication skills in clinical practice. Outcome measures were the number and type of residents' communication skills identified by supervisors in three videotaped simulated resident-patient encounters and the number and type of communication skills discussed interactively with residents during three feedback sessions. 48 clinical supervisors (28 intervention group; 20 control group) participated. After the intervention, the number and type of communication skills identified did not differ between both groups. There was substantial heterogeneity in the number and type of communication skills identified. However, trained participants engaged in interactive discussions with residents on a significantly higher number of communication items (effect sizes 0.53 to 1.77); communication skills items discussed interactively included both structural and patient-centered elements that were considered important to be observed by expert teachers. The faculty development programme did not increase the number of communication skills recognised by supervisors but was effective in increasing the number of communication issues discussed interactively in feedback sessions. Further research should explore the respective impact of accurate identification of communication skills and effective teaching skills on achieving more effective communication skills teaching in clinical practice.

Impact of postgraduate training on communication skills teaching: a controlled study

PubMed Central

2014-01-01

Background Observation of performance followed by feedback is the key to good teaching of communication skills in clinical practice. The fact that it occurs rarely is probably due to clinical supervisors’ perceived lack of competence to identify communication skills and give effective feedback. We evaluated the impact of a faculty development programme on communication skills teaching on clinical supervisors’ ability to identify residents’ good and poor communication skills and to discuss them interactively during feedback. Methods We conducted a pre-post controlled study in which clinical supervisors took part to a faculty development program on teaching communication skills in clinical practice. Outcome measures were the number and type of residents’ communication skills identified by supervisors in three videotaped simulated resident-patient encounters and the number and type of communication skills discussed interactively with residents during three feedback sessions. Results 48 clinical supervisors (28 intervention group; 20 control group) participated. After the intervention, the number and type of communication skills identified did not differ between both groups. There was substantial heterogeneity in the number and type of communication skills identified. However, trained participants engaged in interactive discussions with residents on a significantly higher number of communication items (effect sizes 0.53 to 1.77); communication skills items discussed interactively included both structural and patient-centered elements that were considered important to be observed by expert teachers. Conclusions The faculty development programme did not increase the number of communication skills recognised by supervisors but was effective in increasing the number of communication issues discussed interactively in feedback sessions. Further research should explore the respective impact of accurate identification of communication skills and effective teaching skills on achieving more effective communication skills teaching in clinical practice. PMID:24731477

[Interaction of opioid analgesics at the level of biotransformation].

PubMed

Petri, H; Grandt, D

2016-12-01

Opioids are an important component of the drug treatment of patients with acute and chronic pain. They differ in effectiveness, side effect profile and the risk of interactions. In this article the pharmacokinetic mechanisms of drug-drug interactions at the level of biotransformation are described and the clinical consequences which can arise are discussed. The relation of the active components to the two isoenzymes CYP2D6 and CYP3A4 is of major importance for assessing the potential drug-drug interactions of opioid analgesics at the level of the cytochrome P450 enzyme.

[Diagnosis and therapy of gigantism].

PubMed

Sorgo, W; Teller, W M

1987-01-01

Some of the most important types of nonfamilial tall stature are discussed by stressing the clinical features, diagnostic aspects and therapeutic possibilities. The indications of treatment, the diagnostic procedures and steroid therapy of the familial type of tall stature, the predominant variant of tall stature, are presented in detail. The effects, side effects and contraindications of high dose steroid treatment are described. The important prerequisite for the evaluation of psychosomatic problems of tall stature is the understanding of the dynamics and variations of normal growth. This and the knowledge of methods concerning growth analyses continue to be the basis of an accurate diagnosis.

Combatant eye protection: an introduction to the blue light hazard

NASA Astrophysics Data System (ADS)

Lattimore, Morris R.

2016-05-01

Emerging evidence of metabolic vulnerability to visible blue light is vitally important, as it is indicative of a scalable threshold effect. Added stressors (e.g., increased altitude or contact lens wear) could shift the wavelength effects toward a more damaging clinical picture. Recent reports have indicated rod photo-pigment damage resulting from solar blue-light exposures, adversely affecting unaided night vision, a militarily important performance decrement. The activation wavelength for the daily synchronous setting of the Circadian Clock, which regulates the synchronization of all hormonal and organ systems throughout the body, falls within this blue light perceptual range.

Chlorpromazine versus clotiapine for schizophrenia.

PubMed

Mazhari, Shahrzad; Esmailian, Saeed; Shah-Esmaeili, Armita; Goughari, Ali S; Bazrafshan, Azam; Zare, Morteza

2017-04-07

Schizophrenia is a chronic, disabling and severe mental disorder, characterised by disturbance in perception, thought, language, affect and motor behaviour. Chlorpromazine and clotiapine are among antipsychotic drugs used for the treatment of people with schizophrenia. To determine the clinical effects, safety and cost-effectiveness of chlorpromazine compared with clotiapine for adults with schizophrenia. We searched Cochrane Schizophrenia's Trials Register (last update search 16/01/2016), which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the Register. All randomised clinical trials focusing on chlorpromazine versus clotiapine for schizophrenia. We included trials meeting our selection criteria and reporting useable data. We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE. We have included four studies, published between 1974 and 2003, randomising 276 people with schizophrenia to receive either chlorpromazine or clotiapine. The studies were poor at concealing allocation of treatment and blinding of outcome assessment. Our main outcomes of interest were clinically important change in global and mental state, specific change in negative symptoms, incidence of movement disorder (dyskinesia), leaving the study early for any reason, and costs. All reported data were short-term (under six months' follow-up).The trials did not report data for the important outcomes of clinically important change in global or mental state, or cost of care. Improvement in mental state was reported using the Positive and Negative Syndrome Scale (PANSS). When chlorpromazine was compared with clotiapine the average improvement scores for mental state using the PANSS total was higher in the clotiapine group (1 RCT, N = 31, MD 11.50 95% CI 9.42 to 13.58, very low-quality evidence). The average change scores on the PANSS negative sub-scale were similar between treatment groups (1 RCT, N = 21, MD -0.97 95% CI -2.76 to 0.82, very low-quality evidence). There was no clear difference in incidence of dyskinesia (1 RCT, N = 68, RR 3.00 95% CI 0.13 to 71.15, very low-quality evidence). Similar numbers of participants left the study early from each treatment group (3 RCTs, N = 158, RR 0.68 95% CI 0.24 to 1.88, very low-quality evidence). Clinically important changes in global and mental state were not reported. Only one trial reported the average change in overall mental state; results favour clotiapine but these limited data are very difficult to trust due to methodological limitations of the study. The comparative effectiveness of chlorpromazine compared to clotiapine on change in global state remains unanswered. Results in this review suggest chlorpromazine and clotiapine cause similar adverse effects, although again, the quality of evidence for this is poor, making firm conclusions difficult.

Dental Students' Clinical Experience Across Three Successive Curricula at One U.S. Dental School.

PubMed

White, Joel M; Jenson, Larry E; Gansky, Stuart A; Walsh, Cameron J; Accurso, Brent T; Vaderhobli, Ram M; Kalenderian, Elsbeth; Walji, Muhammad F; Cheng, Jing

2017-04-01

As dental schools continue to seek the most effective ways to provide clinical education for students, it is important to track the effects innovations have on students' clinical experience to allow for quantitative comparisons of various curricula. The aim of this study was to compare the impact of three successive clinical curricula on students' experience at one U.S. dental school. The three were a discipline-based curriculum (DBC), a comprehensive care curriculum (CCC), and a procedural requirement curriculum plus externships (PRCE). Students' clinic experience data from 1992 to 2013 were analyzed for total experience and in five discipline areas. Clinic experience metrics analyzed were patient visits (PVs), relative value units (RVUs), and equivalent amounts (EQAs). A minimum experience threshold (MET) and a high experience threshold (HET) were set at one standard deviation above and below the mean for the DBC years. Students below the MET were designated as low achievers; students above the HET were designated as high achievers. The results showed significant differences among the three curricula in almost all areas of comparison: total PVs, total EQAs, total RVUs, RVUs by discipline, and number of high and low achievers in total clinical experience and by discipline. The comprehensive care approach to clinical education did not negatively impact students' clinical experience and in many cases enhanced it. The addition of externships also enhanced student total clinical experience although more study is needed to determine their effectiveness. The insights provided by this study suggest that the methodology used including the metrics of PVs, EQAs, and RVUs may be helpful for other dental schools in assessing students' clinical experience.

Concussion management in US college football: progress and pitfalls

PubMed Central

Kroshus, Emily

2015-01-01

Reducing the frequency and severity of concussions from sport is an important issue in public health currently addressed by a multifaceted approach. Given the large number of participants and the comparatively high risk of injury, American football is an important sport to consider when examining concussion management practices. Focusing on American football at the collegiate level, this manuscript describes current research regarding concussion epidemiology, policy, implementation of clinical diagnosis, management and return-to-play standards and athlete concussion education. Although American collegiate sports leagues have put forth concussion-related policies in recent years, the implementation of these policies and related effects on athlete concussion education, clinical management of concussion and ultimately athlete health outcomes are not well understood. Additional research is needed. PMID:27064258

On the value of therapeutic interventions targeting the complement system in acute myocardial infarction.

PubMed

Emmens, Reindert W; Wouters, Diana; Zeerleder, Sacha; van Ham, S Marieke; Niessen, Hans W M; Krijnen, Paul A J

2017-04-01

The complement system plays an important role in the inflammatory response subsequent to acute myocardial infarction (AMI). The aim of this study is to create a systematic overview of studies that have investigated therapeutic administration of complement inhibitors in both AMI animal models and human clinical trials. To enable extrapolation of observations from included animal studies toward post-AMI clinical trials, ex vivo studies on isolated hearts and proof-of-principle studies on inhibitor administration before experimental AMI induction were excluded. Positive therapeutic effects in AMI animal models have been described for cobra venom factor, soluble complement receptor 1, C1-esterase inhibitor (C1-inh), FUT-175, C1s-inhibitor, anti-C5, ADC-1004, clusterin, and glycosaminoglycans. Two types of complement inhibitors have been tested in clinical trials, being C1-inh and anti-C5. Pexelizumab (anti-C5) did not result in reproducible beneficial effects for AMI patients. Beneficial effects were reported in AMI patients for C1-inhibitor, albeit in small patient groups. In general, despite the absence of consistent positive effects in clinical trials thus far, the complement system remains a potentially interesting target for therapy in AMI patients. Based on the study designs of previous animal studies and clinical trials, we discuss several issues which require attention in the design of future studies: adjustment of clinical trial design to precise mechanism of action of administered inhibitor, optimizing the duration of therapy, and optimization of time point(s) on which therapeutic effects will be evaluated. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2007-01-01

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

Multivariate evaluation of the cutting performance of rotary instruments with electric and air-turbine handpieces.

PubMed

Funkenbusch, Paul D; Rotella, Mario; Chochlidakis, Konstantinos; Ercoli, Carlo

2016-10-01

Laboratory studies of tooth preparation often involve single values for all variables other than the one being tested. In contrast, in clinical settings, not all variables can be adequately controlled. For example, a new dental rotary cutting instrument may be tested in the laboratory by making a specific cut with a fixed force, but, in clinical practice, the instrument must make different cuts with individual dentists applying different forces. Therefore, the broad applicability of laboratory results to diverse clinical conditions is uncertain and the comparison of effects across studies difficult. The purpose of this in vitro study was to examine the effects of 9 process variables on the dental cutting of rotary cutting instruments used with an electric handpiece and compare them with those of a previous study that used an air-turbine handpiece. The effects of 9 key process variables on the efficiency of a simulated dental cutting operation were measured. A fractional factorial experiment was conducted by using an electric handpiece in a computer-controlled, dedicated testing apparatus to simulate dental cutting procedures with Macor blocks as the cutting substrate. Analysis of variance (ANOVA) was used to assess the statistical significance (α=.05). Four variables (targeted applied load, cut length, diamond grit size, and cut type) consistently produced large, statistically significant effects, whereas 5 variables (rotation per minute, number of cooling ports, rotary cutting instrument diameter, disposability, and water flow rate) produced relatively small, statistically insignificant effects. These results are generally similar to those previously found for an air-turbine handpiece. Regardless of whether an electric or air-turbine handpiece was used, the control exerted by the dentist, simulated in this study by targeting a specific level of applied force, was the single most important factor affecting cutting efficiency. Cutting efficiency was also significantly affected by factors simulating patient/clinical circumstances and hardware choices. These results highlight the greater importance of local clinical conditions (procedure, dentist) in understanding dental cutting as opposed to other hardware-related factors. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Honey - A Novel Antidiabetic Agent

PubMed Central

Erejuwa, Omotayo O.; Sulaiman, Siti A.; Wahab, Mohd S. Ab

2012-01-01

Diabetes mellitus remains a burden worldwide in spite of the availability of numerous antidiabetic drugs. Honey is a natural substance produced by bees from nectar. Several evidence-based health benefits have been ascribed to honey in the recent years. In this review article, we highlight findings which demonstrate the beneficial or potential effects of honey in the gastrointestinal tract (GIT), on the gut microbiota, in the liver, in the pancreas and how these effects could improve glycemic control and metabolic derangements. In healthy subjects or patients with impaired glucose tolerance or diabetes mellitus, various studies revealed that honey reduced blood glucose or was more tolerable than most common sugars or sweeteners. Pre-clinical studies provided more convincing evidence in support of honey as a potential antidiabetic agent than clinical studies did. The not-too-impressive clinical data could mainly be attributed to poor study designs or due to the fact that the clinical studies were preliminary. Based on the key constituents of honey, the possible mechanisms of action of antidiabetic effect of honey are proposed. The paper also highlights the potential impacts and future perspectives on the use of honey as an antidiabetic agent. It makes recommendations for further clinical studies on the potential antidiabetic effect of honey. This review provides insight on the potential use of honey, especially as a complementary agent, in the management of diabetes mellitus. Hence, it is very important to have well-designed, randomized controlled clinical trials that investigate the reproducibility (or otherwise) of these experimental data in diabetic human subjects. PMID:22811614

Low Intensity Shock Wave Treatment for Erectile Dysfunction-How Long Does the Effect Last?

PubMed

Kitrey, Noam D; Vardi, Yoram; Appel, Boaz; Shechter, Arik; Massarwi, Omar; Abu-Ghanem, Yasmin; Gruenwald, Ilan

2018-03-01

We studied the long-term efficacy of penile low intensity shock wave treatment 2 years after an initially successful outcome. Men with a successful outcome of low intensity shock wave treatment according to the minimal clinically important difference on the IIEF-EF (International Index of Erectile Function-Erectile Function) questionnaire were followed at 6, 12, 18 and 24 months. Efficacy was assessed by the IIEF-EF. Failure during followup was defined as a decrease in the IIEF-EF below the minimal clinically important difference. We screened a total of 156 patients who underwent the same treatment protocol but participated in different clinical studies. At 1 month treatment was successful in 99 patients (63.5%). During followup a gradual decrease in efficacy was observed. The beneficial effect was maintained after 2 years in only 53 of the 99 patients (53.5%) in whom success was initially achieved. Patients with severe erectile dysfunction were prone to earlier failure than those with nonsevere erectile dysfunction. During the 2-year followup the effect of low intensity shock wave treatment was lost in all patients with diabetes who had severe erectile dysfunction at baseline. On the other hand, patients with milder forms of erectile dysfunction without diabetes had a 76% chance that the beneficial effect of low intensity shock wave treatment would be preserved after 2 years. Low intensity shock wave treatment is effective in the short term but treatment efficacy was maintained after 2 years in only half of the patients. In patients with milder forms of erectile dysfunction the beneficial effect is more likely to be preserved. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Clinical Outcomes of Specific Immunotherapy in Advanced Pancreatic Cancer: A Systematic Review and Meta-Analysis

PubMed Central

Qi, Xing-Shun

2017-01-01

Specific immunotherapies, including vaccines with autologous tumor cells and tumor antigen-specific monoclonal antibodies, are important treatments for PC patients. To evaluate the clinical outcomes of PC-specific immunotherapy, we performed a systematic review and meta-analysis of the relevant published clinical trials. The effects of specific immunotherapy were compared with those of nonspecific immunotherapy and the meta-analysis was executed with results regarding the overall survival (OS), immune responses data, and serum cancer markers data. The pooled analysis was performed by using the random-effects model. We found that significantly improved OS was noted for PC patients utilizing specific immunotherapy and an improved immune response was also observed. In conclusion, specific immunotherapy was superior in prolonging the survival time and enhancing immunological responses in PC patients. PMID:28265583