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.

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.

Anodal transcranial direct current stimulation of the left dorsolateral prefrontal cortex enhances emotion recognition in depressed patients and controls.

PubMed

Brennan, Sean; McLoughlin, Declan M; O'Connell, Redmond; Bogue, John; O'Connor, Stephanie; McHugh, Caroline; Glennon, Mark

2017-05-01

Transcranial direct current stimulation (tDCS) can enhance a range of neuropsychological functions but its efficacy in addressing clinically significant emotion recognition deficits associated with depression is largely untested. A randomized crossover placebo controlled study was used to investigate the effects of tDCS over the left dorsolateral prefrontal cortex (L-DLPFC) on a range of neuropsychological variables associated with depression as well as neural activity in the associated brain region. A series of computerized tests was administered to clinical (n = 17) and control groups (n = 20) during sham and anodal (1.5 mA) stimulation. Anodal tDCS led to a significant main effect for overall emotion recognition (p = .02), with a significant improvement in the control group (p = .04). Recognition of disgust was significantly greater in the clinical group (p = .01). Recognition of anger was significantly improved for the clinical group (p = .04) during anodal stimulation. Differences between groups for each of the six emotions at varying levels of expression found that at 40% during anodal stimulation, happy recognition significantly improved for the clinical group (p = .01). Anger recognition at 80% during anodal stimulation significantly improved for the clinical group (p = .02). These improvements were observed in the absence of any change in psychomotor speed or trail making ability during anodal stimulation. Working memory significantly improved during anodal stimulation for the clinical group but not for controls (p = .03). The tentative findings of this study indicate that tDCS can have a neuromodulatory effect on a range of neuropsychological variables. However, it is clear that there was a wide variation in responses to tDCS and that individual difference and different approaches to testing and stimulation have a significant impact on final outcomes. Nonetheless, tDCS remains a promising tool for future neuropsychological research.

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review

PubMed Central

van den Ende, Cornelia H. M.; Houterman, Anne E. J.; Heemskerk, Charlotte P. M.; van Dulmen, Sandra; van den Bemt, Bart J. F.

2017-01-01

Objective This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. Methods A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Results Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Conclusion Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF. PMID:28991903

The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

PubMed

van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

2017-01-01

This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

[Advances in studies on bear bile powder].

PubMed

Zhou, Chao-fan; Gao, Guo-jian; Liu, Ying

2015-04-01

In this paper, a detailed analysis was made on relevant literatures about bear bile powder in terms of chemical component, pharmacological effect and clinical efficacy, indicating bear bile powder's significant pharmacological effects and clinical application in treating various diseases. Due to the complex composition, bear bile powder is relatively toxic. Therefore, efforts shall be made to study bear bile powder's pharmacological effects, clinical application, chemical composition and toxic side-effects, with the aim to provide a scientific basis for widespread reasonable clinical application of bear bile powder.

Confidence intervals for effect sizes: compliance and clinical significance in the Journal of Consulting and clinical Psychology.

PubMed

Odgaard, Eric C; Fowler, Robert L

2010-06-01

In 2005, the Journal of Consulting and Clinical Psychology (JCCP) became the first American Psychological Association (APA) journal to require statistical measures of clinical significance, plus effect sizes (ESs) and associated confidence intervals (CIs), for primary outcomes (La Greca, 2005). As this represents the single largest editorial effort to improve statistical reporting practices in any APA journal in at least a decade, in this article we investigate the efficacy of that change. All intervention studies published in JCCP in 2003, 2004, 2007, and 2008 were reviewed. Each article was coded for method of clinical significance, type of ES, and type of associated CI, broken down by statistical test (F, t, chi-square, r/R(2), and multivariate modeling). By 2008, clinical significance compliance was 75% (up from 31%), with 94% of studies reporting some measure of ES (reporting improved for individual statistical tests ranging from eta(2) = .05 to .17, with reasonable CIs). Reporting of CIs for ESs also improved, although only to 40%. Also, the vast majority of reported CIs used approximations, which become progressively less accurate for smaller sample sizes and larger ESs (cf. Algina & Kessleman, 2003). Changes are near asymptote for ESs and clinical significance, but CIs lag behind. As CIs for ESs are required for primary outcomes, we show how to compute CIs for the vast majority of ESs reported in JCCP, with an example of how to use CIs for ESs as a method to assess clinical significance.

Clinical outcomes and patients' perceptions of nurse-led healthy lifestyle clinics.

PubMed

Marshall, Bob; Floyd, Sue; Forrest, Rachel

2011-03-01

The Nurse-Led Healthy Lifestyle Clinics focussed on lifestyle issues for patients with known health inequalities. Much of the nursing was educative and preventative care. This evaluation assessed patient experiences and opinions, as well as clinical outcomes. Information came from clinical outcome data for 2850 individuals and 424 patient satisfaction surveys. Patients were aged 0-95 years (45% between 40 and 59 years); 60% Pakeha/European, 31.4% Maori, 4.2% Pacific and 4.4% other ethnicities. Only 19% of claimants (approximately 40% were Maori or Pacific) came from quintile 5 addresses, suggesting the target population was not reached effectively. Ninety-four percent of patients had a better understanding of their diagnosis, medication and treatment plan, and were more motivated to self-manage their health needs. This increase in patient empowerment is a significant outcome of the project. Clinical outcome data showed no significant differences between first and last clinic visits for average weight, blood pressure, smoking, glycosylated haemoglobin levels, waist circumference or cardiovascular risk. Significant improvements were shown in the Dartmouth Primary Care Cooperative Information results for social activity, change in health, and overall health (n=89). More effective techniques to access the target population have been implemented, as has an extended period for review of clinical outcomes. More focussed evaluation of clinical outcomes is necessary to provide quantitative data on the clinics. The large percentage of patients who felt more empowered to self-manage their health needs suggests the clinics were effective in this area.

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

PubMed

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

2011-12-01

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

Improving organizational climate for quality and quality of care: does membership in a collaborative help?

PubMed

Nembhard, Ingrid M; Northrup, Veronika; Shaller, Dale; Cleary, Paul D

2012-11-01

The lack of quality-oriented organizational climates is partly responsible for deficiencies in patient-centered care and poor quality more broadly. To improve their quality-oriented climates, several organizations have joined quality improvement collaboratives. The effectiveness of this approach is unknown. To evaluate the impact of collaborative membership on organizational climate for quality and service quality. Twenty-one clinics, 4 of which participated in a collaborative sponsored by the Institute for Clinical Systems Improvement. Pre-post design. Preassessments occurred 2 months before the collaborative began in January 2009. Postassessments of service quality and climate occurred about 6 months and 1 year, respectively, after the collaborative ended in January 2010. We surveyed clinic employees (eg, physicians, nurses, receptionists, etc.) about the organizational climate and patients about service quality. Prioritization of quality care, high-quality staff relationships, and open communication as indicators of quality-oriented climate and timeliness of care, staff helpfulness, doctor-patient communication, rating of doctor, and willingness to recommend doctor's office as indicators of service quality. There was no significant effect of collaborative membership on quality-oriented climate and mixed effects on service quality. Doctors' ratings improved significantly more in intervention clinics than in control clinics, staff helpfulness improved less, and timeliness of care declined more. Ratings of doctor-patient communication and willingness to recommend doctor were not significantly different between intervention and comparison clinics. Membership in the collaborative provided no significant advantage for improving quality-oriented climate and had equivocal effects on service quality.

From Bayes through Marginal Utility to Effect Sizes: A Guide to Understanding the Clinical and Statistical Significance of the Results of Autism Research Findings

ERIC Educational Resources Information Center

Cicchetti, Domenic V.; Koenig, Kathy; Klin, Ami; Volkmar, Fred R.; Paul, Rhea; Sparrow, Sara

2011-01-01

The objectives of this report are: (a) to trace the theoretical roots of the concept clinical significance that derives from Bayesian thinking, Marginal Utility/Diminishing Returns in Economics, and the "just noticeable difference", in Psychophysics. These concepts then translated into: Effect Size (ES), strength of agreement, clinical…

Returns to scientific publications for pharmaceutical products in the United States.

PubMed

Slejko, Julia F; Basu, Anirban; Sullivan, Sean D

2018-02-01

Drug-specific clinical and health economic and outcomes research (HEOR) publications have amassed, but their effect on drug sales is largely unknown. We estimated the impact of publications on pharmaceutical sales in 3 markets (statins, rheumatoid arthritis, and asthma drugs) with varying generic competition. An event-study approach with fixed effects and difference-in-fixed-effects modeling was used to estimate the causal effects of drug-specific publications on subsequent quarter's drug-specific sales and volume. High-impact clinical and HEOR publications have significant positive effects on sales (mediated through price) and volume in the statin market (high generic competition). High-impact clinical publications have a significant positive effect on sales (mediated through volume) in low-generic competition market (asthma). The effects of publications in the rheumatoid arthritis market (no generic competition) on sales were null. Manufacturers' investment in clinical and HEOR publications needs to be strategic and should be anticipated and complemented by public investments in such studies. Copyright © 2017 John Wiley & Sons, Ltd.

A Bereavement Support Group Intervention Is Longitudinally Associated with Salutary Effects on the CD4 Cell Count and Number of Physician Visits

PubMed Central

Goodkin, Karl; Feaster, Daniel J.; Asthana, Deshratn; Blaney, Nancy T.; Kumar, Mahendra; Baldewicz, Teri; Tuttle, Raymond S.; Maher, Kevin J.; Baum, Marianna K.; Shapshak, Paul; Fletcher, Mary Ann

1998-01-01

A randomized, controlled, clinical trial was conducted to examine the impact of a semistructured, 10-week, once weekly, 90-min/session bereavement support group intervention on immunological, neuroendocrine, and clinical health status in human immunodeficiency virus type 1-seropositive (HIV-1+) and HIV-1-seronegative (HIV-1−) homosexual men, compared to a standard of care control condition. A total of 119 homosexual men (74 HIV-1+ and 45 HIV-1−) were assessed at baseline, 10 weeks, and 6 months follow-up. At the 6-month follow-up assessment, the intervention groups exhibited significant beneficial effects compared to controls on changes in CD4 cell, total T-lymphocyte, and total lymphocyte counts, when baseline levels, antiretroviral medication use, CDC stage of disease, and other potentially confounding factors were accounted for. There was no statistically significant effect on the CD4/CD8 ratio or on the CD8 cell count. The effect on CD4 cell count was associated with group attendance and with changes in plasma cortisol level. Plasma cortisol levels decreased significantly among intervention subjects, compared to controls. A significantly reduced number of health care visits over the 6-month follow-up period among the intervention subjects supported the clinical relevance of the immunological changes observed for both HIV-1+ and HIV-1− individuals. These results indicate that behavioral interventions may have salutary immunological and clinical health effects following bereavement among HIV-1-infected individuals. The effect in HIV-1− individuals suggests that this bereavement support group intervention might have similar salutary effects in the general population. Potential effects of such interventions on clinical HIV disease progression are of interest and should be studied. PMID:9605995

The effects of detomidine, romifidine or acepromazine on echocardiographic measurements and cardiac function in normal horses.

PubMed

Buhl, Rikke; Ersbøll, Annette K; Larsen, Nanna H; Eriksen, Lis; Koch, Jørgen

2007-01-01

To evaluate by echo- and electrocardiography the cardiac effects of sedation with detomidine hydrochloride, romifidine hydrochloride or acepromazine maleate in horses. An experimental study using a cross-over design without randomization. Eight clinically normal Standardbred trotters. Echocardiographic examinations (two-dimensional, guided M-mode and colour Doppler) were recorded on five different days. Heart rate (HR) and standard limb lead electrocardiograms were also obtained. Subsequently, horses were sedated with detomidine (0.01 mg kg(-1)), romifidine (0.04 mg kg(-1)) or acepromazine (0.1 mg kg(-1)) administered intravenously and all examinations repeated. Heart rate before treatment with the three drugs did not differ significantly (p = 0.98). Both detomidine and romifidine induced a significant decrease (p < 0.001) in HR during the first 25 minutes after sedation; while acepromazine had a varying effect on HR. For detomidine, there was a significant increase in LVIDd (left ventricular internal diameter in diastole; p = 0.034) and LVIDs (left ventricular internal diameter in systole; p < 0.001). In addition, a significant decrease was found in IVSs (the interventricular septum in systole; p < 0.001), LVFWs (the left ventricular free wall in systole; p = 0.002) and FS% (fractional shortening; p < 0.001). The frequency of pulmonary regurgitation was increased significantly (p < 0.001). Romifidine induced a significant increase in LVIDs (p < 0.001) and a significant decrease in IVSs (p < 0.001) and FS% (p = 0.002). Acepromazine had no significant effect upon any of the measured values. and clinical relevance The results indicate that sedation of horses with detomidine and to a lesser extent romifidine at the doses given in this study has a significant effect on heart function, echocardiographic measurements of heart dimensions and the occurrence of valvular regurgitation. Although the clinical significance of these results may be minimal, the potential effects of sedative drugs should be taken into account when echocardiographic variables are interpreted in clinical cases.

Clinic Design and Continuity in Internal Medicine Resident Clinics: Findings of the Educational Innovations Project Ambulatory Collaborative.

PubMed

Francis, Maureen D; Wieland, Mark L; Drake, Sean; Gwisdalla, Keri Lyn; Julian, Katherine A; Nabors, Christopher; Pereira, Anne; Rosenblum, Michael; Smith, Amy; Sweet, David; Thomas, Kris; Varney, Andrew; Warm, Eric; Wininger, David; Francis, Mark L

2015-03-01

Many internal medicine (IM) programs have reorganized their resident continuity clinics to improve trainees' ambulatory experience. Downstream effects on continuity of care and other clinical and educational metrics are unclear. This multi-institutional, cross-sectional study included 713 IM residents from 12 programs. Continuity was measured using the usual provider of care method (UPC) and the continuity for physician method (PHY). Three clinic models (traditional, block, and combination) were compared using analysis of covariance. Multivariable linear regression analysis was used to analyze the effect of practice metrics and clinic model on continuity. UPC, reflecting continuity from the patient perspective, was significantly different, and was highest in the block model, midrange in combination model, and lowest in the traditional model programs. PHY, reflecting continuity from the perspective of the resident provider, was significantly lower in the block model than in combination and traditional programs. Panel size, ambulatory workload, utilization, number of clinics attended in the study period, and clinic model together accounted for 62% of the variation found in UPC and 26% of the variation found in PHY. Clinic model appeared to have a significant effect on continuity measured from both the patient and resident perspectives. Continuity requires balance between provider availability and demand for services. Optimizing this balance to maximize resident education, and the health of the population served, will require consideration of relevant local factors and priorities in addition to the clinic model.

Clinic Design and Continuity in Internal Medicine Resident Clinics: Findings of the Educational Innovations Project Ambulatory Collaborative

PubMed Central

Francis, Maureen D.; Wieland, Mark L.; Drake, Sean; Gwisdalla, Keri Lyn; Julian, Katherine A.; Nabors, Christopher; Pereira, Anne; Rosenblum, Michael; Smith, Amy; Sweet, David; Thomas, Kris; Varney, Andrew; Warm, Eric; Wininger, David; Francis, Mark L.

2015-01-01

Background Many internal medicine (IM) programs have reorganized their resident continuity clinics to improve trainees' ambulatory experience. Downstream effects on continuity of care and other clinical and educational metrics are unclear. Methods This multi-institutional, cross-sectional study included 713 IM residents from 12 programs. Continuity was measured using the usual provider of care method (UPC) and the continuity for physician method (PHY). Three clinic models (traditional, block, and combination) were compared using analysis of covariance. Multivariable linear regression analysis was used to analyze the effect of practice metrics and clinic model on continuity. Results UPC, reflecting continuity from the patient perspective, was significantly different, and was highest in the block model, midrange in combination model, and lowest in the traditional model programs. PHY, reflecting continuity from the perspective of the resident provider, was significantly lower in the block model than in combination and traditional programs. Panel size, ambulatory workload, utilization, number of clinics attended in the study period, and clinic model together accounted for 62% of the variation found in UPC and 26% of the variation found in PHY. Conclusions Clinic model appeared to have a significant effect on continuity measured from both the patient and resident perspectives. Continuity requires balance between provider availability and demand for services. Optimizing this balance to maximize resident education, and the health of the population served, will require consideration of relevant local factors and priorities in addition to the clinic model. PMID:26217420

The effect of short-term workshop on improving clinical reasoning skill of medical students

PubMed Central

Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader

2016-01-01

Background: Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. Methods: This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. Results: The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Conclusion: Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students. PMID:27579286

The effect of short-term workshop on improving clinical reasoning skill of medical students.

PubMed

Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader

2016-01-01

Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students.

Effect of vitamin D supplementation on knee osteoarthritis: A systematic review and meta-analysis of randomized clinical trials.

PubMed

Diao, Naicheng; Yang, Bo; Yu, Fei

2017-12-01

To provide evidence regarding the effect of vitamin D supplementation on symptomatic knee osteoarthritis (OA). A systematic review and meta-analysis was performed to quantitatively pool the results from randomized clinical trials. Studies were identified from a search of the Embase, MEDLINE and Web of Science databases up to January 22, 2017, and also from conference abstracts, ClinicalTrials.gov and the reference lists of identified studies. A standardized mean difference (SMD) was used to assess effect sizes, as outcomes were reported on different scales. Depending on the degree of heterogeneity, random-effects or fixed-effects models were used to pool outcomes. Up to January 22, 2017, four clinical trials containing 570 subjects in the vitamin D supplementation group and 560 subjects in the placebo group were identified. All of the included studies were of high quality and had a low risk of bias for each domain. The results indicated that vitamin D supplementation had a statistically significant but small-to-moderate effect on pain control in patients with knee OA (SMD=-0.32, 95% CI: -0.63 to -0.02). However, no effects were observed for the change in tibial cartilage volume (SMD=0.12, 95% CI: -0.05 to 0.29) or joint space width (SMD=0.07, 95% CI: -0.08 to 0.23). The subgroup analysis indicated that vitamin D supplementation had no significant effect regardless of whether patients had sufficient or insufficient serum 25(OH)D levels at baseline. The results of this study indicate that vitamin D supplementation may not have a clinically significant effect on pain control or structure progression among patients with knee OA. Longer-term clinical trials with rigorous measurement of symptom and radiologic changes are required to further clarify the effect of vitamin D supplementation in patients with symptomatic knee OA and low serum 25(OH)D levels. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

When Trust Is Not Enough: A Serial Mediation Model Explaining the Effect of Race Identity, eHealth Information Efficacy, and Information Behavior on Intention to Participate in Clinical Research.

PubMed

Strekalova, Yulia A

2018-02-01

Black participants remain significantly underrepresented in clinical research. Mistrust in medical researchers has been named a key barrier to the successful enrollment of minority study participants. However, trust is a social-interactional construct, and its effects on behavior are complex. This study hypothesized that intention to participate in clinical research is mediated by trust in medical researchers, eHealth literacy, and information seeking behavior. The data were collected through an online survey ( N = 340) and analyzed to identify serial mediation. The model showed insignificant direct effect of race identity on behavioral intention, c' = -0.19, t(335) = -1.22, p = .22, but a significant total effect, c = -0.44, t(335) = -2.59, p < .01. The indirect effect of race identity on behavioral intention was also significant. The positive effect of trust in medical researchers on decisions to participate in clinical research can be amplified by stronger eHealth literacy and active information seeking, which can be supported through focused strategic health education and communication interventions. A focus on the development of information literacy that could provide prospective minority research volunteers with skills for informed decision making should be explored as an option for increasing mindful, informed participation in clinical research among currently underrepresented racial and ethnic groups.

Integrating evidence-based practice into RN-to-BSN clinical nursing education.

PubMed

Oh, Eui Geum; Kim, Sunah; Kim, So Sun; Kim, Sue; Cho, Eun Yong; Yoo, Ji-Soo; Kim, Hee Soon; Lee, Ju Hee; You, Mi Ae; Lee, Hyejung

2010-07-01

This study examines the effects of integrating evidence-based practice (EBP) into clinical practicum on EBP efficacy and barriers to research utilization among Korean RN-to-BSN students. A one-group pretest-posttest design was used. Eighty-one students were recruited from a school of nursing in Korea. Evidence-based practice clinical practicum was composed of two consecutive programs during one semester. Lectures, individual mentoring on EBP practicum, small group, and wrap-up conferences were provided. Outcomes of EBP efficacy and barriers to research utilization were analyzed using paired t tests for 74 final participants. Evidence-based practice efficacy scores increased significantly (p < 0.05), and the barriers to research utilization scores decreased significantly after the EBP clinical practicum. The results highlight the effectiveness of EBP education among RN-to-BSN students. These results may help health educators develop effective educational strategies to integrate EBP concepts into a clinical practicum. Copyright 2010, SLACK Incorporated.

Pharmacogenomic and clinical data link non-pharmacokinetic metabolic dysregulation to drug side effect pathogenesis

PubMed Central

Zielinski, Daniel C.; Filipp, Fabian V.; Bordbar, Aarash; Jensen, Kasper; Smith, Jeffrey W.; Herrgard, Markus J.; Mo, Monica L.; Palsson, Bernhard O.

2015-01-01

Drug side effects cause a significant clinical and economic burden. However, mechanisms of drug action underlying side effect pathogenesis remain largely unknown. Here, we integrate pharmacogenomic and clinical data with a human metabolic network and find that non-pharmacokinetic metabolic pathways dysregulated by drugs are linked to the development of side effects. We show such dysregulated metabolic pathways contain genes with sequence variants affecting side effect incidence, play established roles in pathophysiology, have significantly altered activity in corresponding diseases, are susceptible to metabolic inhibitors and are effective targets for therapeutic nutrient supplementation. Our results indicate that metabolic dysregulation represents a common mechanism underlying side effect pathogenesis that is distinct from the role of metabolism in drug clearance. We suggest that elucidating the relationships between the cellular response to drugs, genetic variation of patients and cell metabolism may help managing side effects by personalizing drug prescriptions and nutritional intervention strategies. PMID:26055627

Drug interactions among commonly used medications. Chart simplifies data from critical literature review.

PubMed Central

Crowther, N. R.; Holbrook, A. M.; Kenwright, R.; Kenwright, M.

1997-01-01

OBJECTIVE: To simplify risk assessment, we have developed a way to present critically appraised drug interaction information through a chart. DATA SOURCES: Fifty drugs most frequently prescribed by Canadian family physicians and 16 drugs and substances that frequently interact with these drugs were the basis for a literature review. Drug interaction textbooks and MEDLINE (from 1966 to 1994) were searched for documented interactions. Reports of additive effects and animal or in vitro studies were excluded. STUDY SELECTION: All reports of interactions were evaluated for clinical effect, clinical significance, and quality of evidence. SYNTHESIS: Of the 464 drug-drug or drug-substance pairs evaluated, 387 (83.4%) demonstrated an interaction, 59 (12.7%) documented no effect, and 18 (3.9%) pairs had conflicting evidence. Five percent of interactions were of major clinical significance; only 1.3% were of major clinical significance and supported by good-quality evidence. By using symbols, colours, and legends in a "grid-map" format, a large amount of drug interaction information was reduced to a single-page chart suitable for a desk reference or wall mounting. CONCLUSIONS: Our chart organizes a large amount of drug interaction information in a format that allows for rapid appreciation of outcome, clinical significance, and quality of evidence. PMID:9386884

Use of proton pump inhibitors for the provision of stress ulcer prophylaxis: clinical and economic consequences.

PubMed

Barletta, Jeffrey F; Sclar, David A

2014-01-01

The provision of stress ulcer prophylaxis (SUP) for the prevention of clinically significant bleeding is widely recognized as a crucial component of care in critically ill patients. Nevertheless, SUP is often provided to non-critically ill patients despite a risk for clinically significant bleeding of roughly 0.1 %. The overuse of SUP therefore introduces added risks for adverse drug events and cost, with minimal expected benefit in clinical outcome. Historically, histamine-2-receptor antagonists (H2RAs) have been the preferred agent for SUP; however, recent data have revealed proton pump inhibitors (PPIs) as the most common modality (76 %). There are no high quality randomized controlled trials demonstrating superiority with PPIs compared with H2RAs for the prevention of clinically significant bleeding associated with stress ulcers. In contrast, PPIs have recently been linked to several adverse effects including Clostridium difficile diarrhea and pneumonia. These complications have substantial economic consequences and have a marked impact on the overall cost effectiveness of PPI therapy. Nevertheless, PPI use remains widespread in patients who are at both high and low risk for clinically significant bleeding. This article will describe the utilization of PPIs for SUP and present the clinical and economic consequences linked to their use/overuse.

One-year Effects of Vitamin D and Calcium Supplementation on Chronic Periodontitis

PubMed Central

Garcia, M. Nathalia; Hildebolt, Charles F.; Miley, D. Douglas; Dixon, Debra A.; Couture, Rex A.; Spearie, Catherine L. Anderson; Langenwalter, Eric M.; Shannon, William D.; Deych, Elena; Mueller, Cheryl; Civitelli, Roberto

2012-01-01

Background We previously reported in a cross-sectional study that patients who were in periodontal maintenance programs and were taking vitamin D and calcium supplementation had a trend for better periodontal health compared with patients not taking supplementation. The objective of the present study was to determine, for the same group of subjects, whether there was a difference in periodontal health over a one–year period. Methods Fifty-one patients enrolled in maintenance programs from two dental clinics were recruited. Twenty-three were taking vitamin D (≥400 international units/day) and calcium (≥1000mg/day) supplementation, and twenty-eight were not taking supplementation. All subjects had ≥2 interproximal sites with ≥3 mm clinical attachment loss. For mandibular-posterior teeth, these clinical parameters were recorded: gingival index, plaque index, probing depth, attachment loss, bleeding upon probing, calculus index and furcation involvement. Photostimulable-phosphor, posterior bitewing radiographs were taken to assess alveolar bone. Daily vitamin D and calcium intakes were estimated by nutritional analysis. Data were collected at baseline, 6 months, and 12 months. Results Clinical parameters improved with time in both groups (p<0.01). When clinical measures were considered collectively, the results were borderline significant at baseline (p=0.061), significant at 6 months (p=0.049) but not significant at 12 months (p=0.114). After adjusting for covariates, the effect of supplements was significant at baseline (p=0.037), borderline at 6 months (p=0.058) and not significant at 12 months (p=0.142) Conclusion Calcium and vitamin D supplementation has a modest positive effect on periodontal health, and consistent dental care improves clinical parameters of periodontal disease regardless of such supplements. Calcium and vitamin D supplementation has a modest positive effect on periodontal health, and consistent dental care improves clinical parameters of periodontal disease regardless of such supplements. Our findings raise the possibility that vitamin D, perhaps at higher doses, may positively impact on periodontal disease severity. PMID:20809866

Effect of GH/IGF-1 on Bone Metabolism and Osteoporsosis

PubMed Central

Locatelli, Vittorio; Bianchi, Vittorio E.

2014-01-01

Background. Growth hormone (GH) and insulin-like growth factor (IGF-1) are fundamental in skeletal growth during puberty and bone health throughout life. GH increases tissue formation by acting directly and indirectly on target cells; IGF-1 is a critical mediator of bone growth. Clinical studies reporting the use of GH and IGF-1 in osteoporosis and fracture healing are outlined. Methods. A Pubmed search revealed 39 clinical studies reporting the effects of GH and IGF-1 administration on bone metabolism in osteopenic and osteoporotic human subjects and on bone healing in operated patients with normal GH secretion. Eighteen clinical studies considered the effect with GH treatment, fourteen studies reported the clinical effects with IGF-1 administration, and seven related to the GH/IGF-1 effect on bone healing. Results. Both GH and IGF-1 administration significantly increased bone resorption and bone formation in the most studies. GH/IGF-1 administration in patients with hip or tibial fractures resulted in increased bone healing, rapid clinical improvements. Some conflicting results were evidenced. Conclusions. GH and IGF-1 therapy has a significant anabolic effect. GH administration for the treatment of osteoporosis and bone fractures may greatly improve clinical outcome. GH interacts with sex steroids in the anabolic process. GH resistance process is considered. PMID:25147565

Transportability of imagery-enhanced CBT for social anxiety disorder.

PubMed

McEvoy, Peter M; Erceg-Hurn, David M; Barber, Kevin C; Dupasquier, Jessica R; Moscovitch, David A

2018-07-01

Pilot and open trials suggest that imagery-enhanced group cognitive behaviour therapy (CBT) is highly effective for social anxiety disorder (SAD). However, before being considered reliable and generalisable, the effects of the intervention need to be replicated by clinicians in a setting that is independent of the protocol developers. The current study compared outcomes from clients with a principal diagnosis of SAD at the Australian clinic where the protocol was developed (n = 123) to those from an independent Canadian clinic (n = 46) to investigate whether the large effects would generalise. Trainee clinicians from the independent clinic ran the groups using the treatment protocol without any input from its developers. The treatment involved 12 2-h group sessions plus a one-month follow-up. Treatment retention was comparable across both clinics (74% vs. 78%, ≥9/12 sessions) and the between-site effect size was very small and non-significant on the primary outcome (social interaction anxiety, d = 0.09, p = .752). Within-group effect sizes were very large in both settings (ds = 2.05 vs. 2.19), and a substantial minority (41%-44%) achieved clinically significant improvement at follow-up. Replication of treatment effects within an independent clinic and with trainee clinicians increases confidence that outcomes are generalisable. Copyright © 2018 Elsevier Ltd. All rights reserved.

[Efficacy of regular or intermittent inhalation of corticosteroids in treatment of asthma and its effects on growth and development in children].

PubMed

Li, Lin-Wei; Huang, Ying; Luo, Rong; Yan, Li; Li, Qu-Bei; Peng, Dong-Hong; Shu, Chang

2015-03-01

To observe the efficacy of regular or intermittent inhalation of salmeterol/fluticasone propionate (SM/FP) in the treatment of bronchial asthma and its effects on growth and development in children. A total of 112 children diagnosed with bronchial asthma between September 2012 and October 2013 were assigned to standardized treatment (standard group, n=56) and non-standardized treatment (intermittent group, n=56). Comparisons of clinical symptom scores and main pulmonary function indicators between the two groups were carried out before treatment and at 6 and 12 months after treatment. The growth velocity and changes in body mass index (BMI) were observed in the two groups. At 6 and 12 months after the treatment, the standard group had significantly reduced clinical symptom scores and significantly increased pulmonary function indicators (percentage of predicted peak expiratory flow, PEF%; percentage of forced expiratory volume in 1 second, FEV1%) (P<0.05); the intermittent group had significantly reduced clinical symptom scores and significantly increased FEV1% (P<0.05), but PEF% was significantly increased only at 6 months after treatment (P<0.05). At 12 months after treatment, the standard group had significantly lower clinical symptom scores and significantly higher PEF% and FEV1% when compared with the intermittent group (P<0.05). The growth velocity and BMI showed no significant differences between the two groups at 6 and 12 months after treatment (P>0.05). Compared with intermittent inhalation, long-term regular inhalation of SM/FP performs better in controlling clinical symptoms and enhancing pulmonary function in children with asthma. Inhalation of SM/FP for one year reveals no apparent effect on the growth and development of these children.

Factors influencing acute weight change in patients with schizophrenia treated with olanzapine, haloperidol, or risperidone.

PubMed

Basson, B R; Kinon, B J; Taylor, C C; Szymanski, K A; Gilmore, J A; Tollefson, G D

2001-04-01

Clinical factors predicting weight change in patients with schizophrenia and related disorders during acute treatment with the antipsychotic drugs olanzapine, risperidone, and haloperidol were sought through retrospective analyses. Six-week body-weight data from 2 trials, study 1 comparing olanzapine and haloperidol (N = 1,369) and study 2 olanzapine and risperidone (N = 268), were analyzed. Effects of 8 clinically relevant covariates--therapy, clinical outcome (Brief Psychiatric Rating Scale), baseline body mass index (BBMI), increased appetite, age, gender, race, and dose--on weight were compared. In study 1, olanzapine (vs. haloperidol) therapy, better clinical outcome, lower BBMI, and nonwhite race significantly affected weight gain. Effects of increased appetite and male gender on weight gain were significant for olanzapine but not for haloperidol. In study 2, better clinical outcome, lower BBMI, and younger age significantly affected weight gain. Increased appetite was more frequent during olanzapine treatment than during haloperidol, but not significantly different from risperidone. Significant differences in effect on weight change were found between olanzapine and haloperidol but not between olanzapine and risperidone. No evidence was found that lower antipsychotic drug doses were associated with lower weight gain. This report identifies predictive factors of acute weight change in patients with schizophrenia. Similar factors across antipsychotic drugs in predicting greater weight gain included better clinical outcome, low BBMI, and nonwhite race. Factors differing between conventional (haloperidol) and atypical (olanzapine) agents included increased appetite and gender. Choice of atypical antipsychotic drug (olanzapine vs. risperidone) was of minor importance with regard to influence on acute weight gain.

Service innovation: a comparison of two approaches for physical screening of psychiatric inpatients.

PubMed

Harrison, Mark Richard; McMillan, Catherine Frances; Dickinson, Timothy

2012-06-01

Psychiatric medications have clear links to obesity, diabetes, dyslipidaemia, hypertension, hyperprolactinaemia and movement disorders. These disorders are a common cause of morbidity and mortality in psychiatric patients but physical screening by health services is often haphazard. We report the findings of an audit of physical screening across two hospital wards. Each ward undertook a process of service improvement. One ward modified the admissions proforma and the other developed a discharge screening clinic. The effectiveness of each of these interventions was then compared through a reaudit of practice across both wards. At baseline, screening was performed inconsistently and infrequently. On average, the modified admissions proforma increased screening rates by 4.7% compared to 30.7% for discharge screening clinics. The discharge screening clinic demonstrated statistically significant improvements in screening rates and effectively delivered health promotion advice. Discharge screening clinics are significantly more likely than improved admissions procedures to detect clinically significant abnormalities. If these abnormalities are detected and treated then the long-term physical health of psychiatric patients may be improved.

[THE TRUE OR FALSE BACTERIEMIA: THE SIGNIFICANCE OF EVALUATION CRITERIA OF CLINICAL SIGNIFICANCE OF POSITIVE HEMOCULTURE].

PubMed

Bagirova, N S

2015-08-01

The diagnostic of infections of blood flow using technique of hemofermentation (blood inoculation) is one of the most significant functions of laboratory of clinical microbiology. The effectiveness of the given technique depends on many factors, including criteria of evaluation of clinical significance of episode of bacteriemia and isolated microorganism applied by physician-microbiologist. The intelligent analysis of received results is needed. The physician-microbiologist has to determine if microorganism isolated from given blood sample, is a genuine agent of infections of bloodflow or it is only effect of contamination of analyzed sample at certain stage. The article presents data concerning taxonomic structure of microorganisms isolated under episodes of bacteriemia of adult oncologic hematologic patients during 2005-2013. The criteria of evaluation of clinical significance of episode of bacteriemia and isolated microorganism are described. The given criteria are developed in the N.N. Blokhin Russian oncological research center and are applied since 1977. The cases of contamination and genuine bacteriemia are established. The comparative analysis of international data and results of one's own study are carried out.

A comparison of propensity score-based approaches to health service evaluation: a case study of a preoperative physician-led clinic for high-risk surgical patients.

PubMed

Pham, Clarabelle T; Gibb, Catherine L; Mittinty, Murthy N; Fitridge, Robert A; Marshall, Villis R; Karnon, Jonathan D

2016-10-01

A physician-led clinic for the preoperative optimization and management of high-risk surgical patients was implemented in a South Australian public hospital in 2008. This study aimed to estimate the costs and effects of the clinic using a mixed retrospective and prospective observational study design. Alternative propensity score estimation methods were applied to retrospective routinely collected administrative and clinical data, using weighted and matched cohorts. Supplementary survey-based prospective data were collected to inform the analysis of the retrospective data and reduce potential unmeasured confounding. Using weighted cohorts, clinic patients had a significantly longer mean length of stay and higher mean cost. With the matched cohorts, reducing the calliper width resulted in a shorter mean length of stay in the clinic group, but the costs remained significantly higher. The prospective data indicated potential unmeasured confounding in all analyses other than in the most tightly matched cohorts. The application of alternative propensity-based approaches to a large sample of retrospective data, supplemented with a smaller sample of prospective data, informed a pragmatic approach to reducing potential observed and unmeasured confounding in an evaluation of a physician-led preoperative clinic. The need to generate tightly matched cohorts to reduce the potential for unmeasured confounding indicates that significant uncertainty remains around the effects of the clinic. This study illustrates the value of mixed retrospective and prospective observational study designs but also underlines the need to prospectively plan for the evaluation of costs and effects alongside the implementation of significant service innovations. © 2016 John Wiley & Sons, Ltd.

[Clinical outcomes and economic analysis of two ovulation induction protocols in patients undergoing repeated IVF/ICSI cycles].

PubMed

Chen, Xiao; Geng, Ling; Li, Hong

2014-04-01

To compare the clinical outcomes and cost-effectiveness of luteal phase down-regulation with gonadotrophin-releasing hormone (GnRH) agonist protocol and GnRH antagonist protocol in patients undergoing repeated in vitro fertilization and intracytoplasmic sperm injection (IVF-ICSI) cycles. A retrospective analysis of clinical outcomes and costs was conducted among 198 patients undergoing repeated IVF-ICSI cycles, including 109 receiving luteal phase down-regulation with GnRH agonist protocol (group A) and 89 receiving GnRH antagonist protocol (group B). The numbers of oocytes retrieved and good embryos, clinical pregnancy rate, abortion rate, the live birth rate, mean total cost, and the cost-effective ratio were compared between the two groups. In patients undergoing repeated IVF-ICSI cycles, the two protocols produced no significant differences in the number of good embryos, clinical pregnancy rate, abortion rate, or twin pregnancy rate. Compared with group B, group A had better clinical outcomes though this difference was not statistically significant. The number of retrieved oocytes was significantly greater and live birth rate significantly higher in group A than in group B (9.13=4.98 vs 7.11=4.74, and 20.2% vs 9.0%, respectively). Compared with group B, group A had higher mean total cost per cycle but lower costs for each oocyte retrieved (2729.11 vs 3038.60 RMB yuan), each good embryo (8867.19 vs 9644.85 RMB yuan), each clinical pregnancy (77598.06 vs 96139.85 RMB yuan). For patients undergoing repeated IVF/ICSI cycle, luteal phase down-regulation with GnRH agonist protocol produces good clinical outcomes with also good cost-effectiveness in spite an unsatisfactory ovarian reserve.

Comparison of Two brands of Methylphenidate (Stimdate(®) vs. Ritalin(®)) in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized Clinical Trial.

PubMed

Khodadust, Naser; Jalali, Amir-Hossein; Ahmadzad-Asl, Masoud; Khademolreza, Noushin; Shirazi, Elham

2012-01-01

To compare the effectiveness and safety of the methylphenidate produced in Iran (Stimdate®) with its original brand (Ritalin®) in children with Attention deficit hyperactivity disorder (ADHD). In this double-blinded randomized clinical trial, 30 patients with ADHD who were 6 to 16 years old, were divided into two groups: 15 in Stimdate® and 15 in Ritalin® group. The two groups were compared for side effects profile, Conner's Parent's Rating Scale-Persion version (CPRS-R), Child Symptom Inventory-4 (CSI-4), Clinical Global Impressions (CGI), and Children's Global Assessment Scale (CGAS), at baseline and at the 4(th) and 6(th) weeks. The subjects showed significant decreases in the CPRS-Rand CSI-4 scores and significant increase of CGAS scores during the follow-up, but there were no significant difference between Stimdate® and Ritalin® group, regarding the pattern of changes observed. The mean therapeutic dose and the number of side effects were not significantly different between the two studied groups. Both Stimdate® and Ritalin® had comparable clinical efficacy and safety in children with ADHD.

Effect of dry period length on the effect of an intramammary teat sealant on the risk of mastitis in cattle treated with antibiotics at drying off.

PubMed

Laven, R A; Balcomb, C C; Tulley, W T; Lawrence, K E

2014-07-01

The aim of this study was to evaluate, under farm conditions, the use of a teat sealant in addition to whole herd dry cow antibiotic therapy on the risk of clinical mastitis in dairy cattle at pasture, and to evaluate the impact of dry period length on that risk and the impact of the teat sealant on that risk. Dairy cows in three herds which used routine whole herd antibiotic therapy were randomly assigned to receive either treatment with an internal teat sealant (n=322) or no additional treatment (n=313) at drying-off between March and May 2010. All clinical mastitis cases during the dry period and to the end of the subsequent lactation were recorded by farm staff; factors affecting risk of clinical mastitis were then analysed using a Cox proportional hazards model. Median duration of the dry period was 112 days with >25% of cows having a dry period >130 days. The incidence risk of mastitis during lactation for cows treated with teat sealant was 9.9 (95% CI=6.9-13.7) cases per 100 cows compared with 17.9 (95% CI=13.8-22.6) cases per 100 cows for cows treated with antibiotic alone. The addition of a teat sealant to dry cow antibiotic therapy decreased the risk of clinical mastitis only in the first 33 days after calving (Hazard risk 0.24 (95% CI=0.12-0.48)). Length of dry period did not significantly affect the risk of clinical mastitis, or the effect of adding teat sealant to dry cow antibiotic therapy on the risk of clinical mastitis. In these herds where, based on the mastitis history, whole herd antibiotic therapy had been recommended, the use of a teat sealant significantly reduced the risk of clinical mastitis. This effect was limited to the first 33 days after calving; subsequently there was no significant effect of treatment. There was no effect of dry period length on risk of clinical mastitis, nor any significant interaction with treatment. Combination therapy with teat sealant and antibiotic was effective under New Zealand conditions in herds using whole herd antibiotic treatment at drying off. Teat sealant reduced risk of clinical mastitis in cattle with dry periods substantially longer than 100 days, and there was no evidence that this effect changed as dry period length increased.

Results from the Xylitol for Adult Caries Trial (X-ACT)

PubMed Central

Bader, James D.; Vollmer, William M.; Shugars, Daniel A.; Gilbert, Gregg H.; Amaechi, Bennett T.; Brown, John P.; Laws, Reesa L.; Funkhouser, Kimberly A.; Makhija, Sonia K.; Ritter, André V.; Leo, Michael C.

2013-01-01

Background Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults. Methods X-ACT was a three-site placebo-controlled randomized trial. Participants (n=691) ages 21–80 consumed five 1.0 g xylitol or placebo lozenges daily for 33 months. Clinical examinations occurred at baseline, 12, 24 and 33 months. Results Xylitol lozenges reduced the caries increment 11%. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among elevated caries-risk adults. Clinical Implications These results suggest that xylitol used as a supplement in adults does not significantly reduce their caries experience. PMID:23283923

Do clinical safety charts improve paramedic key performance indicator results? (A clinical improvement programme evaluation).

PubMed

Ebbs, Phillip; Middleton, Paul M; Bonner, Ann; Loudfoot, Allan; Elliott, Peter

2012-07-01

Is the Clinical Safety Chart clinical improvement programme (CIP) effective at improving paramedic key performance indicator (KPI) results within the Ambulance Service of New South Wales? The CIP intervention area was compared with the non-intervention area in order to determine whether there was a statistically significant improvement in KPI results. The CIP was associated with a statistically significant improvement in paramedic KPI results within the intervention area. The strategies used within this CIP are recommended for further consideration.

Clinical value of concurrent radiochemotherapy in cervical cancer and comparison of ultrasonography findings before and after radiochemotherapy.

PubMed

Yan, W M; Li, X Z; Yu, Z L; Zhang, J; Sun, X G

2015-04-17

Herein, we investigated the clinical value of concurrent radiochemotherapy for patients with advanced cervical cancer and its effects on adverse clinical symptoms. Forty patients with cervical cancer were recruited from January 2011 to January 2014 for this study. Participants were randomly allocated into a test or control group, with 20 patients in each group. Patients in the test group were treated with concurrent radiochemotherapy, whereas patients in the control group received only traditional radiotherapy. At the end of the observation period, clinical efficacy in the two groups was compared. Patients were followed up for 2 years, and the rates of recurrence, survival, and complications were compared; ultrasonographic findings before and after radiotherapy were also correlated. Patients in the test group who received concurrent radiochemotherapy showed significantly higher clinical efficacy than the control group at the end of treatment cycles. After 2 years of follow-up, the rates of recurrence, mortality, and complications were all significantly lower in the test group than in the control group (P < 0.05). Comparison of ultrasonographic findings before and after radiochemotherapy showed that the size of the tumor was significantly smaller in patients after concurrent radiochemotherapy. Compared with traditional radiotherapy, concurrent radiochemotherapy significantly improved clinical outcomes in patients with advanced cervical cancer. Concurrent radiochemotherapy also enhanced the rate of survival and decreased the rate of relapse, with enhanced clinical safety and no significant side effects. Thus, concurrent radiochemotherapy can be more broadly applied in the treatment of advanced cervical cancer.

Comparing the effectiveness of ultrasound-guided versus blind steroid injection in the treatment of severe carpal tunnel syndrome

PubMed

Karaahmet, Özgür Zeliha; Gürçay, Eda; Kara, Murat; Serçe, Azize; Kıraç Ünal, Zeynep; Çakcı, Aytül

2017-12-19

Background/aim: This study aimed to compare the effectiveness of ultrasound (US)-guided injection versus blind injection of corticosteroids in the treatment of carpal tunnel syndrome (CTS). Materials and methods: This prospective, randomized clinical trial included patients with severe CTS based on clinical and electrophysiological criteria. The patients were evaluated for clinical and electrophysiological parameters at baseline and 4 weeks after treatment. Symptom severity and hand function were assessed by the Boston questionnaire. The patients underwent blind injection or US-guided injection. Results: When compared with baseline, both groups showed significant improvement in Boston questionnaire scores and all electrophysiological parameters. Significant differences were observed between the groups for clinical parameters (Boston Symptom Severity Scale: P = 0.007; Functional Status Scale: P < 0.001) in favor of the US-guided group. Conclusion: This study demonstrated that both US-guided and blind injections were effective in reducing symptoms and improving hand function. US-guided injections may yield more effective clinical results in the short-term than blind injections in the treatment of patients with severe CTS.

Effect of surgical hand scrub time on subsequent bacterial growth.

PubMed

Wheelock, S M; Lookinland, S

1997-06-01

In this experimental study, the researchers evaluated the effect of surgical hand scrub time on subsequent bacterial growth and assessed the effectiveness of the glove juice technique in a clinical setting. In a randomized crossover design, 25 perioperative staff members scrubbed for two or three minutes in the first trial and vice versa in the second trial, after which the wore sterile surgical gloves for one hour under clinical conditions. The researchers then sampled the subjects' nondominant hands for bacterial growth, cultured aliquots from the sampling solution, and counted microorganisms. Scrubbing for three minutes produced lower mean log bacterial counts than scrubbing for two minutes. Although the mean bacterial count differed significantly (P = .02) between the two-minute and three-minute surgical hand scrub times, it fell below 0.5 log, which is the threshold for practical and clinical significance. This finding suggests that a two-minute surgical hand scrub is clinically as effective as a three-minute surgical had scrub. The glove juice technique demonstrated sensitivity and reliability in enumerating bacteria on the hands of perioperative staff members in a clinical setting.

Efficacy of rivastigmine for cognitive symptoms in Parkinson disease with dementia.

PubMed

Almaraz, Amy C; Driver-Dunckley, Erika D; Woodruff, Bryan K; Wellik, Kay E; Caselli, Richard J; Demaerschalk, Bart M; Adler, Charles H; Caviness, John N; Wingerchuk, Dean M

2009-07-01

Impairment of multiple neurotransmitter networks, including acetylcholine, may contribute to the cognitive impairment in patients with Parkinson disease with dementia (PDD). Therefore, cholinesterase inhibitors might improve cognitive function in PDD. On the other hand, enhancing cholinergic function could plausibly worsen features of parkinsonism. To determine if oral cholinesterase inhibitors improve measures of cognitive outcome and are tolerated by people with PDD. We addressed the question through the development of a critically appraised topic. Participants included consultant and resident neurologists, clinical epidemiologists, a medical librarian, and behavioral neurology and movement disorder specialists. Participants began with a structured clinical question, devised search strategies, compiled the best evidence, performed a critical appraisal, summarized the evidence, provided commentary, and declared bottom-line conclusions. A randomized controlled trial (n = 541) showed that, compared with placebo, rivastigmine (mean, 8.6 mg/d) significantly improved scores on 2 coprimary cognitive outcome scales in PDD, including the Alzheimer disease Cooperative Study-Clinician's Global Impression of Change. When dichotomized to evaluate clinically significant benefit (moderate or marked improvement), this outcome was not significant (risk difference = 5.3%; 95% confidence interval (CI) = -1.6 to 12.1). The number needed to treat (NNT) to avoid clinically significant worsening of cognition was 10 (95% CI = 6-28). The NNT for the combined outcome of either achieving clinically significant benefit or avoiding significant worsening was 7. The numbers needed to harm for cholinergic side effects were 9 (95% CI = 5-24) for parkinsonian symptoms and 11 (95% CI = 6-32) for rivastigmine discontinuation due to any side effect. Rivastigmine therapy for PDD is associated with significant tradeoffs in efficacy and adverse effects. Carefully monitored trials of rivastigmine may provide meaningful benefits for a minority of PDD patients.

Ulysses: the effectiveness of a multidisciplinary cognitive behavioural pain management programme-an 8-year review.

PubMed

Fullen, B M; Blake, C; Horan, S; Kelley, V; Spencer, O; Power, C K

2014-06-01

To characterise a cohort of patients with chronic pain registered to the Ulysses cognitive behavioural pain management programme (CBT-PMP) and to evaluate the effectiveness of the CBT-PMP 6 months post-discharge. A review of patients referred to the Ulysses CBT-PMP from 2002 to 2010 was undertaken. The profile of patients was established. Domains measured included pain, physical and psychological function. Relationships between these factors were explored. Clinically significant changes in outcome measures were established at the 6-month follow-up. In total 553 patients registered to the CBT-PMP, pre-post data were available for 91 % of patients and 52 % at 6 months. The majority of patients were female and aged between 40 and 50 years. Most patients had significant psychological morbidity (76 % depression, 84.5 % anxiety), moderate reports of pain [numerical rating scale, mean (SD) 6.0 (2.2)], and low levels of functional activity. At 6 months follow-up, statistically significant positive findings for physical and psychological outcome measures are supplemented by results showing their clinical significance. With regard to psychological function, a clinically significant change (depending on outcome measure) was shown between 1 in 2 and 1 in 10 patients. Improvements in physical function were lower with rates of 1 in 4 to 1 in 14 reporting significant gains. The effectiveness of the Ulysses CBT-PMP is established with measures of clinically significant change for physical and psychological outcomes contributing to the evidence for this novel approach of analysis. Future research determining benchmarks for CBT-PMP outcomes will assist clinicians in monitoring and enhancing patient's progress in clinical practice.

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.

Valbenazine for Tardive Dyskinesia.

PubMed

Freudenreich, Oliver; Remington, Gary

Tardive dyskinesia (TD) remains a clinical concern for any patient who receives an antipsychotic. While the overall risk of developing TD is lower with newer antipsychotics compared to older agents, a significant number of patients who require long-term treatment will develop TD. Recently, valbenazine (brand name Ingrezza) became the first drug to be approved by the FDA specifically for the treatment of TD. In this New Drug Review, we summarize the basic pharmacology and clinical trial results for valbenazine. Valbenazine is a modified metabolite of the vesicular monoamine transporter 2 (VMAT-2) inhibitor tetrabenazine, which is approved for the treatment of the hyperkinetic movement disorder, Huntington's disease. In short-term clinical trials, valbenazine at a dose of 80 mg/day improved TD, with an effect size that is clinically significant (d=0.90). The effect size for the 40-mg/day dose was lower (d=0.52). Compared to tetrabenazine, valbenazine has better clinical characteristics (i.e., once-a-day dosing, better short-term side effect profile). However, only long-term experience in routine clinical populations can delineate valbenazine's full benefits, optimal dosing, and risks not identified during short-term registration trials.

The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials.

PubMed

Stanmore, Emma; Stubbs, Brendon; Vancampfort, Davy; de Bruin, Eling D; Firth, Joseph

2017-07-01

Physically-active video games ('exergames') have recently gained popularity for leisure and entertainment purposes. Using exergames to combine physical activity and cognitively-demanding tasks may offer a novel strategy to improve cognitive functioning. Therefore, this systematic review and meta-analysis was performed to establish effects of exergames on overall cognition and specific cognitive domains in clinical and non-clinical populations. We identified 17 eligible RCTs with cognitive outcome data for 926 participants. Random-effects meta-analyses found exergames significantly improved global cognition (g=0.436, 95% CI=0.18-0.69, p=0.001). Significant effects still existed when excluding waitlist-only controlled studies, and when comparing to physical activity interventions. Furthermore, benefits of exergames where observed for both healthy older adults and clinical populations with conditions associated with neurocognitive impairments (all p<0.05). Domain-specific analyses found exergames improved executive functions, attentional processing and visuospatial skills. The findings present the first meta-analytic evidence for effects of exergames on cognition. Future research must establish which patient/treatment factors influence efficacy of exergames, and explore neurobiological mechanisms of action. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Disentangling body image: The relative associations of overvaluation, dissatisfaction, and preoccupation with psychological distress and eating disorder behaviors in male and female adolescents.

PubMed

Mitchison, Deborah; Hay, Phillipa; Griffiths, Scott; Murray, Stuart B; Bentley, Caroline; Gratwick-Sarll, Kassandra; Harrison, Carmel; Mond, Jonathan

2017-02-01

The distinctiveness and relative clinical significance of overvaluation, dissatisfaction, and preoccupation with body weight/shape remains inconclusive. This study sought to add to the evidence by testing associations between these three body image constructs and indicators of clinical significance. Male and female secondary students (N = 1,666) aged 12-18 years completed a survey that included measures of dissatisfaction with, overvaluation of, and preoccupation with weight/shape, psychological distress, eating disorder behaviors, and basic demographic information. Conditional process analysis was employed to test the independent and mediating effects of overvaluation, dissatisfaction, and preoccupation on distress, dietary restraint, and objective binge eating. Overvaluation, dissatisfaction, and preoccupation were highly correlated (r = 0.47-0.84). In girls, preoccupation demonstrated the strongest independent and mediating effects on distress, dietary restraint, and binge eating; whereas neither the direct or indirect effects of dissatisfaction on distress and overvaluation on binge eating were significant. Among boys however, the direct and indirect effects of overvaluation, dissatisfaction, and preoccupation on distress and eating disorder behaviors were relatively equal. Preoccupation with weight/shape may be particularly clinically significant in girls, whereas all constructs of body image disturbance may be equally clinically significant in boys. The findings are consistent with the view that these constructs, while closely related, are distinct. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:118-126). © 2016 Wiley Periodicals, Inc.

A patient-centered clinical evaluation of acellular dermal matrix graft in the treatment of gingival recession defects.

PubMed

Mahajan, Ajay; Dixit, Jaya; Verma, Umesh Pratap

2007-12-01

The present randomized controlled trial was conducted to evaluate acellular dermal matrix (ADM) graft in terms of patient satisfaction and its effectiveness and efficiency in the treatment of gingival recession. Fourteen patients (seven males and seven females) with Miller Class I and II recessions > or =3 mm participated in this 6-month clinical study. They were assigned randomly to the ADM group (ADM graft and coronally positioned flap [CPF]) or the CPF group (CPF alone). Results were evaluated based on parameters measuring patient satisfaction and clinical outcomes associated with the two treatment procedures. Significance was set at P <0.05. The mean recession was 4.0 +/- 1.0 mm and 3.7 +/- 0.7 mm for the ADM and CPF groups, respectively. For the ADM group, the defect coverage was 3.85 +/- 0.89 mm or 97.14% compared to the CPF group, in which the defect coverage was 2.85 +/- 0.89 mm or 77.42%. The difference between the two groups was statistically significant (P <0.05). There were no statistically significant differences between the two groups in the remaining clinical parameters and overall patient satisfaction except in criteria related to patient comfort and cost effectiveness, in which CPF alone produced significantly better results (P <0.03). ADM graft is significantly superior with regard to effectiveness and efficiency in the treatment of gingival recession than CPF alone. CPF emerges as a better option than ADM graft in terms of cost effectiveness and patient comfort.

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

PubMed

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

2002-01-01

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

Clinical study of double dose of valsartan combined with tacrolimus in treatment of diabetic nephropathy.

PubMed

Jin, H; Zhang, H-N; Hou, X-L; Zhang, B; Wu, J; Zhang, H-B

2016-01-01

To investigate the clinical effect of double dose of valsartan combined with tacrolimus in the treatment of diabetic nephropathy (DN). HA total of 86 cases diagnosed with DN were selected from October 2013 to October 2014 in Zaozhuang Municipal Hospital, China. The study was approved by our hospital Ethics Committee and written consent was obtained from patients and their family members. Patients were randomly divided into three groups according to the sequence of admission, group A (conventional dose of valsartan group, n = 28 cases), group B (double dose of valsartan group, n = 29 cases) and group C (double dose of valsartan combined with tacrolimus group, n = 29). Clinical effects were compared by analyzing the renal function tests after 8 weeks. 24h urine protein, serum creatinine level of patients in group B and group C were significantly lower than that of group A. Those in group C was much lower. The glomerular filtration rates were significantly higher for group B and C than that of group A, and those in group C were much higher. The difference is statistically significant (p < 0.05). High-sensitivity C-reactive protein (hs CRP) and adiponectin levels of patients in group B and C of were significantly lower than that of group A and those in group C were much lower. The difference is statistically significant (p < 0.05). The high mobility group protein 1 (HMGB1) and renal tubular and interstitial damage index (TDI) of patients in B and C groups were significantly lower than those in the A group, and those in C group were significantly lower. The difference was statistically significant p < 0.05). The clinical effective rates of patients in group B and C were significantly higher than that in group A, and those of group C were much higher. The difference is statistically significant (p < 0.05). The recurrence rates of patients in group B and group C were significantly lower than those of group A and those in group C were much lower. The difference is statistically significant (p < 0.05). Patients in three groups showed no obvious drug complications. Double dose of valsartan combined with tacrolimus treatment of DN patients can improve clinical symptoms, reducing inflammation, inhibiting or even reversing the interstitial fibrosis, which will improve the curative effect and reduce the recurrence, as to provide a new theoretical basis for the clinical treatment of the disease.

Intensive inpatient treatment for bulimia nervosa: Statistical and clinical significance of symptom changes.

PubMed

Diedrich, Alice; Schlegl, Sandra; Greetfeld, Martin; Fumi, Markus; Voderholzer, Ulrich

2018-03-01

This study examines the statistical and clinical significance of symptom changes during an intensive inpatient treatment program with a strong psychotherapeutic focus for individuals with severe bulimia nervosa. 295 consecutively admitted bulimic patients were administered the Structured Interview for Anorexic and Bulimic Syndromes-Self-Rating (SIAB-S), the Eating Disorder Inventory-2 (EDI-2), the Brief Symptom Inventory (BSI), and the Beck Depression Inventory-II (BDI-II) at treatment intake and discharge. Results indicated statistically significant symptom reductions with large effect sizes regarding severity of binge eating and compensatory behavior (SIAB-S), overall eating disorder symptom severity (EDI-2), overall psychopathology (BSI), and depressive symptom severity (BDI-II) even when controlling for antidepressant medication. The majority of patients showed either reliable (EDI-2: 33.7%, BSI: 34.8%, BDI-II: 18.1%) or even clinically significant symptom changes (EDI-2: 43.2%, BSI: 33.9%, BDI-II: 56.9%). Patients with clinically significant improvement were less distressed at intake and less likely to suffer from a comorbid borderline personality disorder when compared with those who did not improve to a clinically significant extent. Findings indicate that intensive psychotherapeutic inpatient treatment may be effective in about 75% of severely affected bulimic patients. For the remaining non-responding patients, inpatient treatment might be improved through an even stronger focus on the reduction of comorbid borderline personality traits.

Long-term Treatment with Finasteride Resulted in a Significant Improvement Relative to Placebo in Clinical Progression of Benign Prostatic Hyperplasia (BPH) in Men with Enlarged Prostates (≥30 mL), But Not in Those with Smaller Prostates (<30 mL): Data from the Medical Therapy of Prostatic Symptoms (MTOPS) Trial

PubMed Central

Kaplan, Steven A.; Lee, Jeannette Y.; Meehan, Alan G.; Kusek, John W.

2013-01-01

Purpose This post hoc analysis of the Medical Therapy of Prostatic Symptoms (MTOPS) trial examined the effect of finasteride alone compared to placebo on clinical progression of benign prostatic hyperplasia (BPH) in men with baseline prostate volume (PV) <30 mL and ≥30 mL. Materials and Methods Men were randomized to placebo (n=737), doxazosin alone (4 to 8 mg) (n=756), finasteride alone (5 mg) (n=768), or doxazosin plus finasteride (n=786) (average duration of follow-up was 4.5 yrs); ~50% of patients had a baseline PV ≥30 mL. The present analysis was based on the finasteride alone and placebo arms only and included patients for whom baseline and end of study data were available. We examined the effect of treatment on the cumulative percentage of men who did not experience clinical progression of BPH by study end. Results In men with baseline PV ≥30 mL, treatment with finasteride produced a significant (p<0.001) increase relative to placebo in the cumulative percentage of patients who did not experience clinical progression of BPH (finasteride, 88.1%, versus placebo, 77.8%). There was no significant (p=0.441) between-group difference in men with baseline PV <30 mL (91.4% versus 89.1%, respectively). Conclusions Long-term treatment with finasteride led to a significant beneficial effect compared to placebo on clinical progression of BPH in LUTS patients with enlarged prostates (baseline PV ≥30 mL). Finasteride had no significant effect, compared to placebo on clinical progression of BPH in LUTS patients with smaller prostates (baseline PV <30 mL). PMID:21334655

The efficacy of supplementation with the novel medical food, Souvenaid, in patients with Alzheimer's disease: A systematic review and meta-analysis of randomized clinical trials.

PubMed

Onakpoya, Igho J; Heneghan, Carl J

2017-05-01

Certain nutritional supplements are being marketed for the management of Alzheimer's disease (AD), but the evidence for their effectiveness is not established. The objective of this review was to evaluate the evidence from randomized clinical trial (RCTs) examining the effect of Souvenaid in patients with AD. We conducted electronic searches in Medline, Embase, PsychINFO, CINAHL, and The Cochrane Library. The reporting quality of the included studies was determined using the Cochrane collaboration tool for assessing the risk of bias. Two reviewers independently determined eligibility, assessed the reporting quality of included studies and extracted data. Three studies with a total of 1011 participants were included. All were of good reporting quality. Meta-analyses revealed non-significant differences in cognition (ADAS-cog scores MD: 0.08, 95% CI: -0.71 to 0.88) and function (ADCS-ADL scores MD: 0.36, 95% CI: -0.54 to 1.25) between Souvenaid and placebo. One study showed significant increase in neuropsychological test battery composite z-score with Souvenaid compared with placebo, and another reported significant improvement in delayed verbal recall for a subgroup of patients with very mild AD. There was no significant effect on global clinical function. No serious adverse events were observed. The evidence from published clinical trials does not show that supplementation with Souvenaid has beneficial effects on functional ability, behaviour, or global clinical change. Souvenaid may cause improvements in verbal recall in patients at early stages of AD. Few RCTs examining the effect of Souvenaid have been conducted, and they are all funded by same manufacturer. Future research should include using unified tools to measure cognition, function, and behaviour in AD.

Ablation effects of noninvasive radiofrequency field-induced hyperthermia on liver cancer cells.

PubMed

Chen, Kaiyun; Zhu, Shuguang; Xiang, Guoan; Duan, Xiaopeng; He, Jiwen; Chen, Guihua

2016-05-01

To have in-depth analysis of clinical ablation effect of noninvasive radiofrequency field-induced hyperthermia on liver cancer cells, this paper collected liver cancer patients' treatment information from 10 hospitals during January 2010 and December 2011, from which 1050 cases of patients were randomly selected as study object of observation group who underwent noninvasive radiofrequency field-induced hyperthermia treatment; in addition, 500 cases of liver cancer patients were randomly selected as study object of control group who underwent clinical surgical treatment. After treatment was completed, three years of return visit were done, survival rates of the two groups of patients after 1 year, 2 years, and 3 years were compared, and clinical effects of radiofrequency ablation of liver cancer were evaluated. Zoom results show that the two groups are similar in terms of survival rate, and the difference is without statistical significance. 125 patients in observation group had varying degrees of adverse reactions, while 253 patients in control group had adverse reactions. There was difference between groups P < 0.05, with significant statistical significance. It can be concluded that radiofrequency ablation of liver cancer is more secure. Therefore, the results of this study fully demonstrate that liver cancer treatment with noninvasive radiofrequency field-induced hyperthermia is with safety effect and satisfactory survival rate, thus with relatively high clinical value in clinical practice.

Can Cognitive Behavioral Therapy for Insomnia also treat fatigue, pain, and mood symptoms in individuals with traumatic brain injury? - A multiple case report.

PubMed

Lu, William; Krellman, Jason W; Dijkers, Marcel P

2016-01-01

Individuals with traumatic brain injury (TBI) often develop sleep disorders post-injury. The most common one is insomnia, which can exacerbate other post-injury symptoms, including fatigue, impaired cognition, depression, anxiety, and pain. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a manualized treatment that effectively treats insomnia with secondary effects on cognition, mood, and pain in various populations. This paper reviews the use of CBT-I for three participants with TBI of different severities. Pre- and post-treatment assessments of insomnia, fatigue, depression, anxiety, and pain were conducted. Mood was further assessed at follow-up. Minimal clinically important difference (MCID) scores derived from the research literature were used to establish clinically meaningful symptom improvement on self-report questionnaires. The reduction in insomnia severity scores for all three participants were not large enough to be considered a clinically significant improvement following CBT-I, although trends toward improvement were observed. However, all participants showed clinically significant reductions in anxiety at post-treatment; the effects persisted for 2 participants at follow-up. Reductions in depression symptoms were observed for 2 participants at post-treatment, and treatment effects persisted for 1 participant at follow-up. One participant endorsed clinically significant improvements in fatigue and pain severity. We conclude that CBT-I may provide secondary benefits for symptoms commonly experienced by individuals with TBI, especially mood disturbances.

[Clinical study on treatment of 405 cases of irregular menstruation by tiaojing zhixue granules].

PubMed

Ma, Kun; Sun, Li-hua; Wang, Qing-hua

2003-01-01

To provide scientific and objective basis for Tiaojing zhixue granules treating irregular menstruation of clinical effect. Choose 405 cases suffering from irregular menstruation and make a systematic study 304 patients were treated with Tiaojing Zhixue granules, 101 patients received Fuxuening treatment. After treatment, the obvious effective rate of Tiaojing Zhixue granules was 78.3% and the total effective rate 97.4%, granule cure rate of Fuxuening was 38.6% and the total effective rate 87.1%. Comparison showed significant difference (P < 0.001). Safety spithetical observation did not discover harmful effects and toxicity and side effects antagonize common symptoms 26 entries of clinical studying, the 7 entry are: weary and tired, short breaths, sore loins, weak knees, insomnia and eccessive dreaming, rapid and thready pulse, colliquative, distending pain in the lower abdomen and hypochondria. Among them, the comparison showed significant difference about treatments(P < 0.01-0.001). Tiaojing Zhixue granules treatment irregular menstruation are scientific and effective.

Tocotrienol Treatment in Familial Dysautonomia: Open-Label Pilot Study.

PubMed

Cheishvili, David; Maayan, Channa; Holzer, Naama; Tsenter, Jeanna; Lax, Elad; Petropoulos, Sophie; Razin, Aharon

2016-07-01

Familial dysautonomia (FD) is an autosomal recessive congenital neuropathy, primarily presented in Ashkenazi Jews. The most common mutation in FD patients results from a single base pair substitution of an intronic splice site in the IKBKAP gene which disrupts normal mRNA splicing and leads to tissue-specific reduction of IKBKAP protein (IKAP). To date, treatment of FD patients remains preventative, symptomatic and supportive. Based on previous in vitro evidence that tocotrienols, members of the vitamin E family, upregulate transcription of the IKBKAP gene, we aimed to investigate whether a similar effects was observed in vivo. In the current study, we assessed the effects of tocotrienol treatment on FD patients' symptoms and IKBKAP expression in white blood cells. The initial daily doses of 50 or 100 mg tocotrienol, doubled after 3 months, was administered to 32 FD patients. Twenty-eight FD patients completed the 6-month study. The first 3 months of tocotrienol treatment was associated with a significant increase in IKBKAP expression level in FD patients' blood. Despite doubling the dose after the initial 3 months of treatment, IKBKAP expression level returned to baseline by the end of the 6-month treatment. Clinical improvement was noted in the reported clinical questionnaire (with regard to dizziness, bloching, sweating, number of pneumonia, cough episodes, and walking stability), however, no significant effect was observed in any clinical measurements (weight, height, oxygen saturation, blood pressure, tear production, histamine test, vibration threshold test, nerve conduction, and heart rate variability) following Tocotrienol treatment. In conclusion, tocotrienol treatment appears significantly beneficial by clinical evaluation for some FD patients in a few clinical parameters; however it was not significant by clinical measurements. This open-label study shows the complexity of effect of tocotrienol treatment on FD patients' clinical outcomes and on IKBKAP expression level compared to in vitro results. A longitudinal study with an increased sample size is required in the future to better understand tocotrienol affect on FD patients.

Antiproliferative and Apoptotic Effects of Lidocaine on Human Hepatocarcinoma Cells. A preliminary study.

PubMed

Jurj, Ancuta; Tomuleasa, Ciprian; Tat, Tiberiu T; Berindan-Neagoe, Ioana; Vesa, Stefan V; Ionescu, Daniela C

2017-03-01

It is now well documented that certain anesthetic techniques may influence long term outcome in cancer patients undergoing surgery. More recently, local anesthetics proved certain antiproliferative effects in cancer cells. In our study, we aimed to investigate if lidocaine has antiproliferative effects in human hepatocarcinoma cells and to identify possible mechanisms of these effects. We investigated the inhibitory effect of different concentrations of lidocaine on the proliferation of cultured HepG2 human hepatocarcinoma cells and LX2 normal liver fibroblasts. Cells were exposed to nine different concentrations of lidocaine for 72h. MTT assay was used to investigate HepG2 and LX2 proliferation while Western blotting was used for detection of p53 expression level. Our data showed that lidocaine inhibited cell proliferation in a concentration-dependent manner in both HepG2 and LX2. The antiproliferative effects of lidocaine in LX2 were significantly diminished as compared with those in HepG2 (p< 0.001). Similarly, the expression level of p53 was significant decreased in HepG2 lines treated with lidocaine as compared with control and LX2 (p = 0.0241). In clinically relevant concentrations, lidocaine had significant antiproliferative effects on human hepatocarcinoma cells. These effects were time and dose-dependent. One of the possible mechanisms of these effects is by modifying the P53 expression level. The relevance of these findings in clinical practice is limited; clinical impact of these effects on the outcome of patients with hepatocarcinoma undergoing surgery or minimal invasive procedures needs to be demonstrated in future animal models and clinical studies.

The timing of administration of a clinically relevant dose of losartan influences the healing process after contusion induced muscle injury.

PubMed

Kobayashi, Tetsuo; Uehara, Kenji; Ota, Shusuke; Tobita, Kimimasa; Ambrosio, Fabrisia; Cummins, James H; Terada, Satoshi; Fu, Freddie H; Huard, Johnny

2013-01-15

Losartan (Los) is a Food and Drug Administration-approved antihypertensive medication that has a well-tolerated side effect profile. We have demonstrated that treatment with Los immediately after injury was effective at promoting muscle healing and inducing an antifibrotic effect in a murine model of skeletal muscle injury. We initially investigated the minimum effective dose of Los administration immediately after injury and subsequently determined whether the timing of administering a clinically relevant dose of Los would influence its effectiveness at improving muscle healing after muscle injury. In the first part of this study, mice were administered 3, 10, 30, or 300 mg·kg(-1)·day(-1) of Los immediately after injury, and the healing process was evaluated histologically and physiologically 4 wk after injury. In the second study, the clinically relevant dose of 10 mg·kg(-1)·day(-1) was administered immediately or started at 3 or 7 days postinjury. The administration of 300 mg·kg(-1)·day(-1) immediately following injury led to a significant increase in muscle regeneration, a significant decrease in fibrosis, and an improvement in muscle function. Moreover, we observed a significant decrease in fibrosis and a significant increase in muscle regeneration at 4 wk postinjury, when the clinically relevant dose of 10 mg·kg(-1)·day(-1) was administered at 3 or 7 days postinjury. Functional evaluation also demonstrated a significant improvement compared with the injured untreated control when Los treatment was initiated 3 days after injury. Our study revealed accelerated muscle healing when the 300 mg·kg(-1)·day(-1) of Los was administered immediately after injury and a clinically relevant dose of 10 mg·kg(-1)·day(-1) of Los was administered at 3 or 7 days postinjury.

Lipemia interferences in routine clinical biochemical tests.

PubMed

Calmarza, Pilar; Cordero, José

2011-01-01

Lipemic specimens are a common and frequent, but yet unresolved problem in clinical chemistry, and may produce significant interferences in the analytical results of different biochemical parameters. The aim of this study was to examine the effect of lipid removal using ultracentrifugation of lipemic samples, on some routine biochemistry parameters. Among all the samples obtained daily in our laboratory, the ones which were visibly muddy were selected and underwent to a process of ultracentrifugation, being determined a variety of biochemical tests before and after ultracentrifugation. A total of 110 samples were studied. We found significant differences in all the parameters studied except for total bilirubin, glucose, gamma-glutamyl transferase (GGT) and aspartate aminotransferase (AST). The greatest differences in the parameters analyzed were found in the concentration of alanine aminotransferase (ALT) (7.36%) and the smallest ones in the concentration of glucose (0.014%). Clinically significant interferences were found for phosphorus, creatinine, total protein and calcium. Lipemia causes clinically significant interferences for phosphorus, creatinine, total protein and calcium measurement and those interferences could be effectively removed by ultracentrifugation.

Vedolizumab: a review of its use in adult patients with moderately to severely active ulcerative colitis or Crohn's disease.

PubMed

Garnock-Jones, K P

2015-02-01

Vedolizumab (Entyvio™) is a humanized monoclonal antibody α4β7 integrin-receptor antagonist indicated for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn's disease. This article reviews the pharmacological properties of intravenous infusions of vedolizumab and its clinical efficacy in adult patients with these diseases. In phase III clinical trials, patients with ulcerative colitis had significantly higher rates of clinical response and clinical remission when treated with vedolizumab than when receiving placebo at both 6 and 52 weeks. However, outcomes with vedolizumab in patients with Crohn's disease were mixed. In a study that evaluated both clinical remission rate and CDAI-100 response rate as primary endpoints, only the clinical remission rate at 6 weeks was significantly higher with vedolizumab than placebo. In another trial, there was no significant between-group difference in the clinical remission rate in TNF-antagonist failure patients at 6 weeks (primary endpoint), although there was a significant difference at 10 weeks. In the Crohn's disease study that included maintenance treatment, vedolizumab was significantly more effective at 52 weeks than placebo in both endpoints (clinical remission was the only primary endpoint in the maintenance study). Vedolizumab was generally well tolerated in these trials. As vedolizumab is a specific α4β7 integrin antagonist, with gut-specific effects, it is unlikely to be associated with the development of progressive multifocal leukoencephalopathy, a risk observed with the less selective α4β7/α4β1 integrin antagonist natalizumab. Vedolizumab is a useful addition to the treatment options available for patients with moderately to severely active ulcerative colitis and Crohn's disease.

Clinical relevance of findings in trials of CBT for depression.

PubMed

Lepping, P; Whittington, R; Sambhi, R S; Lane, S; Poole, R; Leucht, S; Cuijpers, P; McCabe, R; Waheed, W

2017-09-01

Cognitive behavioural therapy (CBT) is beneficial in depression. Symptom scores can be translated into Clinical Global Impression (CGI) scale scores to indicate clinical relevance. We aimed to assess the clinical relevance of findings of randomised controlled trials (RCTs) of CBT in depression. We identified RCTs of CBT that used the Hamilton Rating Scale for Depression (HAMD). HAMD scores were translated into Clinical Global Impression - Change scale (CGI-I) scores to measure clinical relevance. One hundred and seventy datasets from 82 studies were included. The mean percentage HAMD change for treatment arms was 53.66%, and 29.81% for control arms, a statistically significant difference. Combined active therapies showed the biggest improvement on CGI-I score, followed by CBT alone. All active treatments had better than expected HAMD percentage reduction and CGI-I scores. CBT has a clinically relevant effect in depression, with a notional CGI-I score of 2.2, indicating a significant clinical response. The non-specific or placebo effect of being in a psychotherapy trial was a 29% reduction of HAMD. Copyright © 2017. Published by Elsevier Masson SAS.

Evaluation of Clinical and Communication Skills of Pharmacy Students and Pharmacists with an Objective Structured Clinical Examination.

PubMed

Urteaga, Elizabeth M; Attridge, Rebecca L; Tovar, John M; Witte, Amy P

2015-10-25

Objective. To evaluate how effectively pharmacy students and practicing pharmacists communicate and apply knowledge to simulations of commonly encountered patient scenarios using an objective structured clinical examination (OSCE). Design. Second-, third-, and fourth-year pharmacy students completed an OSCE as part of their required courses in 2012 and 2013. All students in both years completed identical OSCE cases. Licensed pharmacists were recruited to complete the OSCE and serve as controls in 2012. A survey assessed student perception and acceptance of the OSCE as well as student confidence in performance. Assessment. Licensed pharmacists had significantly higher clinical and communication skills scores than did pharmacy students. Student progression in communication and clinical skills improved significantly over time. Survey results indicated that students felt the OSCE was well-structured and assessed clinical skills taught in pharmacy school; 86% of students felt confident they could provide these skills. Conclusion. Objective structured clinical examinations can evaluate clinical competence and communication skills among professional students. Implementation of OSCEs may be an effective tool for assessment of the Center for the Advancement of Pharmacy Education domains.

Infrared sauna in patients with rheumatoid arthritis and ankylosing spondylitis. A pilot study showing good tolerance, short-term improvement of pain and stiffness, and a trend towards long-term beneficial effects.

PubMed

Oosterveld, Fredrikus G J; Rasker, Johannes J; Floors, Mark; Landkroon, Robert; van Rennes, Bob; Zwijnenberg, Jan; van de Laar, Mart A F J; Koel, Gerard J

2009-01-01

To study the effects of infrared (IR) Sauna, a form of total-body hyperthermia in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) patients were treated for a 4-week period with a series of eight IR treatments. Seventeen RA patients and 17 AS patients were studied. IR was well tolerated, and no adverse effects were reported, no exacerbation of disease. Pain and stiffness decreased clinically, and improvements were statistically significant (p < 0.05 and p < 0.001 in RA and AS patients, respectively) during an IR session. Fatigue also decreased. Both RA and AS patients felt comfortable on average during and especially after treatment. In the RA and AS patients, pain, stiffness, and fatigue also showed clinical improvements during the 4-week treatment period, but these did not reach statistical significance. No relevant changes in disease activity scores were found, indicating no exacerbation of disease activity. In conclusion, infrared treatment has statistically significant short-term beneficial effects and clinically relevant period effects during treatment in RA and AS patients without enhancing disease activity. IR has good tolerability and no adverse effects.

A review of the effects of impermeable bedding encasements on dust-mite allergen exposure and bronchial hyper-responsiveness in dust-mite-sensitized patients.

PubMed

Recer, G M

2004-02-01

Sensitization and exposure to dust-mite antigens are causative factors in the development and exacerbation of asthma. Impermeable bedding encasements are considered a first-line treatment to reduce dust-mite antigen exposure in clinical asthma-management guidelines. Public-health recommendations for environmental asthma treatments should be based on the weight of evidence supporting the reliability of environmental interventions so that uncertainties regarding their effectiveness can be accurately communicated to patients, and so that limited public-health resources can be most effectively utilized. To evaluate the strength of a clinical-trial evidence supporting the efficacy of bedding encasements as an asthma treatment. A narrative review was conducted of all clinical trials involving bedding encasement for the treatment of asthma. Collective statistical analyses were also performed to characterize the quantitative effect of bedding encasement on dust-mite allergen exposure and bronchial hyper-responsiveness (BHR) when used by asthma patients. Over 30 clinical trials were reviewed. Of those studies reporting adequate exposure and BHR results, four reported significant reduction in dust-mite allergen exposure and concomitant BHR reduction in active-treatment groups using bedding encasements. In 10 studies, mite-allergen exposure was reportedly decreased during the study, but BHR was not changed in the active-treatment group or was reduced to a similar degree in the active-treatment and control groups. Five other studies reported a lack of significant effect of the intervention on exposure and BHR. Collective paired analyses found that the effect of bedding encasement on allergen exposure and BHR tended toward only a modest, non-significant improvement. Collectively, effects of bedding encasement on BHR and dust-mite allergen exposure were modestly correlated only when the baseline exposure was above 2 microg Type 1 antigen per gram settled dust. Although bedding encasement might be an effective asthma treatment under some conditions, when implemented in clinical trials by asthma patients, its effectiveness is inconsistent and appears to be, at best, modest. Therefore, its significance as a reliable asthma management modality for any individual asthma patient is uncertain. Where resource constraints are significant, targeting the use of variably effective interventions such as bedding encasements toward those patient sub-populations most likely to derive substantial benefit may gain the largest net public-health benefit.

The effect of high-fidelity patient simulation on the critical thinking and clinical decision-making skills of new graduate nurses.

PubMed

Maneval, Rhonda; Fowler, Kimberly A; Kays, John A; Boyd, Tiffany M; Shuey, Jennifer; Harne-Britner, Sarah; Mastrine, Cynthia

2012-03-01

This study was conducted to determine whether the addition of high-fidelity patient simulation to new nurse orientation enhanced critical thinking and clinical decision-making skills. A pretest-posttest design was used to assess critical thinking and clinical decision-making skills in two groups of graduate nurses. Compared with the control group, the high-fidelity patient simulation group did not show significant improvement in mean critical thinking or clinical decision-making scores. When mean scores were analyzed, both groups showed an increase in critical thinking scores from pretest to posttest, with the high-fidelity patient simulation group showing greater gains in overall scores. However, neither group showed a statistically significant increase in mean test scores. The effect of high-fidelity patient simulation on critical thinking and clinical decision-making skills remains unclear. Copyright 2012, SLACK Incorporated.

Determination of minimum suction level necessary for field dental units.

PubMed

Charlton, David G

2010-04-01

A significant problem with most field dental units is that their suction is too weak to effectively remove debris from the mouth. The purpose of this study was to determine the minimum clinically acceptable suction level for routine dentistry. A vacuum pump was connected to a high-volume dental evacuation line in a simulated clinical setting and different suction airflow rates were evaluated by nine evaluator dentists for their capability to effectively remove amalgam debris and water. Airflow levels were rated as "clinically acceptable" or "clinically unacceptable" by each evaluator. Data were analyzed using a chi2 test for trend. Analysis indicated a significant linear trend between airflow and ratings (p < 0.0001). The first airflow level considered by all evaluators as producing clinically acceptable suction was 4.5 standard cubic feet per minute (0.127 standard cubic meters per minute). This value should be the minimum level required for all military field dental units.

[Development and Effects of Assertiveness Training applying Dongsasub Training for Nursing Students in Clinical Practice].

PubMed

Kim, Myoungsuk

2016-08-01

This study was conducted to develop assertiveness training applying Dongsasub training for junior nursing students, and to verify effectiveness of the training on assertiveness behavior, self-esteem, clinical practice stress, and clinical competence. The study design was a non-equivalent control group non-synchronized design. Participants were 63 nursing students in clinical training (31 students in the experimental group and 32 students in the control group). The assertiveness training applying Dongsasub training consisted of four sessions. Outcome variables included assertiveness behavior, self-esteem, clinical practice stress, and clinical competence. Data were analyzed using Chi-square, Fisher's exact test and independent samples t-test with SPSS/WIN 21.0. Scores of assertiveness behavior (t=-2.49, p=.015), self-esteem (t=-4.80, p<.001) and clinical competence (t=-2.33, p=.023) were significantly higher and clinical practice stress (t=4.22, p<.001) was significantly lower in the experimental group compared to the control group. Results indicate that the assertiveness training applying Dongsasub training can be used as a nursing intervention to lower clinical practice stress and improve the clinical competence of nursing students.

Effects of Home-Based Versus Clinic-Based Rehabilitation Combining Mirror Therapy and Task-Specific Training for Patients With Stroke: A Randomized Crossover Trial.

PubMed

Hsieh, Yu-Wei; Chang, Ku-Chou; Hung, Jen-Wen; Wu, Ching-Yi; Fu, Mu-Hui; Chen, Chih-Chi

2018-04-25

We investigated the treatment effects of a home-based rehabilitation program compared with clinic-based rehabilitation in patients with stroke. A single-blinded, 2-sequence, 2-period, crossover-designed study. Rehabilitation clinics and participant's home environment. Individuals with disabilities poststroke. During each intervention period, each participant received 12 training sessions, with a 4-week washout phase between the 2 periods. Participants were randomly allocated to home-based rehabilitation first or clinic-based rehabilitation first. Intervention protocols included mirror therapy and task-specific training. Outcome measures were selected based on the International Classification of Functioning, Disability and Health. Outcomes of impairment level were the Fugl-Meyer Assessment, Box and Block Test, and Revised Nottingham Sensory Assessment. Outcomes of activity and participation levels included the Motor Activity Log, 10-meter walk test, sit-to-stand test, Canadian Occupational Performance Measure, and EuroQoL-5D Questionnaire. Pretest analyses showed no significant evidence of carryover effect. Home-based rehabilitation resulted in significantly greater improvements on the Motor Activity Log amount of use subscale (P=.01) and the sit-to-stand test (P=.03) than clinic-based rehabilitation. The clinic-based rehabilitation group had better benefits on the health index measured by the EuroQoL-5D Questionnaire (P=.02) than the home-based rehabilitation group. Differences between the 2 groups on the other outcomes were not statistically significant. The home-based and clinic-based rehabilitation groups had comparable benefits in the outcomes of impairment level but showed differential effects in the outcomes of activity and participation levels. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Advances in the management of multiple sclerosis spasticity: recent clinical trials.

PubMed

Fernández, Oscar

2014-01-01

Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex®) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. In pivotal clinical trials of THC:CBD oromucosal spray, a meaningful proportion of patients with treatment-resistant MS spasticity achieved clinically relevant improvement with active treatment versus placebo. The utility of a 4-week trial of therapy to identify patients who respond to treatment was demonstrated in an enriched-design study. THC:CBD oromucosal spray was well tolerated in these studies, with no evidence of effects typically associated with recreational cannabis use. In a subsequent post approval clinical trial, THC:CBD oromucosal spray had no statistically significant effect on cognition and mood compared with placebo. Moreover, after 50 weeks' treatment, approximately two-thirds of patients, physicians and caregivers reported improvement from baseline in spasticity based on global impressions of change. Key Messages: In phase III clinical trials, approximately one-third of MS patients with treatment-resistant spasticity had a clinically relevant and statistically significant response to THC:CBD oromucosal spray. In addition to a reduction in spasticity, responders experienced meaningful relief from associated symptoms. THC:CBD oromucosal spray was generally well tolerated and efficacy was maintained over the longer term. A post-approval clinical trial indicated no effect of THC:CBD oromucosal spray on cognition or mood after 50 weeks of use. © 2014 S. Karger AG, Basel.

Comparative study between: Carboxytherapy, platelet-rich plasma, and tripolar radiofrequency, their efficacy and tolerability in striae distensae.

PubMed

Ahmed, Naglaa A; Mostafa, Osama M

2018-06-19

Striae distensae are very common cutaneous disorders that produce great psychological stress for women. measure and compare between efficacy and tolerability of three modalities for treatment of striae distensae. Forty-five female patients with striae distensae were randomly selected from the outpatient dermatology clinics of Al-Zahra university Hospital within 6 months period. Patients divided into three groups according to the therapeutic modalities were used. Group A: treated with carboxytherapy using carbon dioxide (CO2) injection, Group B: where patients were treated with intradermal injection of autologous platelet-rich plasma (PRP), and Group C: where we used tripolar radiofrequency (RF) for treatment. All treated groups showed overall clinical improvement as regards the width, texture, and overall improvement after treatment (P > .05), with no statistically significant differences between the three groups. Patient's satisfaction was statistically significantly better in both group C (93.33%) and group A (80%) while group B (53.33%) was less with minimal side effects such as pain and ecchymosis, which were more frequent in group B than the other two groups; but with no statistically significance differences both groups A and C were effective with no significant differences in both types of striae and in any site of the body but group B is significantly more effective on striae rubra on trunk, with better improvement of lesions texture. The three modalities of treatments proved to be effective clinically and histopathologically in treating both types of striae, which were well tolerated by the patients with minimal, transient side effects and our study results gave us guidelines for their clinical application. © 2018 Wiley Periodicals, Inc.

Relation between spiritual intelligence and clinical competency of nurses in Iran

PubMed Central

Karimi-Moonaghi, Hossein; Gazerani, Akram; Vaghee, Saeed; Gholami, Hassan; Salehmoghaddam, Amir Reza; Gharibnavaz, Raheleh

2015-01-01

Background: Clinical competency is one of the most important requirements in nursing profession, based on which nurses are assessed. To obtain an effective and improved form of clinical competency, several factors are observed and monitored by the health educational systems. Among these observed factors, spiritual intelligence is considered as one of the most significant factors in nurses’ success and efficacy. In this study, it is aimed to determine the spiritual intelligence status and its relationship with clinical competency. Materials and Methods: The descriptive–correlational research was carried out on 250 nurses in Mashhad educational hospitals, selected by multi-stage sampling. Demographic, clinical competency, and spiritual intelligence questionnaires were used for data collection and 212 questionnaires were analyzed. Results: About 53.3% of nurses obtained above average scores in spiritual intelligence. Clinical competency was evaluated by both self-evaluation and head nurse evaluation methods. Most nurses (53.8%) were having good level of clinical competency based on self-evaluation, 48.2% were at average level based on head nurse evaluation, and 53.3% were at average level based on overall score. A significant correlation was found between spiritual intelligence and clinical competency. Conclusions: In this study, the positive significant correlation between nurses’ spiritual intelligence and their clinical competency is investigated. Because of the positive effects of spiritual intelligence on nurses’ clinical competency and quality of care, it is recommended to develop nurses’ spiritual intelligence during their education and by way of continuous medical education. PMID:26793250

Effect of Adding Oral Calcium Dobesilate to Laser Photocoagulation on the Macular Thickness in Patients with Diabetic Macular Edema: A Randomized Clinical Trial

PubMed Central

Feghhi, Mostafa; Farrahi, Fereydoun; Abbaspour, Mohammadreza; Takhtaeian, Akbar

2014-01-01

Purpose: To evaluate the effect of oral calcium dobesilate (Doxium) on macular thickness in clinically significant macular edema (CSME). Methods: Overall, 71 eyes of 40 patients with non-proliferative diabetic retinopathy and clinically significant macular edema were included. All patients were received laser treatment for macular edema. Coherence optical tomography was used to determine the retinal thickness. Patients were randomized into two groups: group A received three Doxium capsule daily and group B received three placebo capsule daily for six months. Results: The mean macular thickness before and after treatment in the group A was 340 and 257 micrometers respectively (24.5% reduced), and in the group B was 336 micrometers and 263 micrometers respectively (21.5% reduced). Macular thickness significantly decreased after treatment in both groups and the reduction in group A is higher but the difference of reduction between the two groups was not statistically significant (P>0.05). Conclusion: In respect to the effect of adding oral Doxium to Laser Photocoagulation on the macular thickness in patients with diabetic macular edema, this study showed no statistically significant difference between Doxium and placebo. PMID:25436194

Ginger extracts influence the expression of IL-27 and IL-33 in the central nervous system in experimental autoimmune encephalomyelitis and ameliorates the clinical symptoms of disease.

PubMed

Jafarzadeh, A; Mohammadi-Kordkhayli, M; Ahangar-Parvin, R; Azizi, V; Khoramdel-Azad, H; Shamsizadeh, A; Ayoobi, A; Nemati, M; Hassan, Z M; Moazeni, S M; Khaksari, M

2014-11-15

The immunomodulatory effects of the IL-27 and IL-33 and the anti-inflammatory effects of ginger have been reported in some studies. The aim was to evaluate the effects of the ginger extract on the expression of IL-27 and IL-33 in a model of experimental autoimmune encephalomyelitis (EAE). In PBS-treated EAE mice the expression of IL-27 P28 was significantly lower whereas the expression of IL-33 was significantly higher than unimmunized control mice. In 200 and 300 mg/kg ginger-treated EAE groups the expression of IL-27 P28 and IL-27 EBI3 was significantly higher whereas the expression of IL-33 was significantly lower than PBS-treated EAE mice. The EAE clinical symptoms and the pathological scores were significantly lower in ginger-treated EAE groups. These results showed that the ginger extract modulates the expression of the IL-27 and IL-33 in the spinal cord of EAE mice and ameliorates the clinical symptoms of disease. Copyright © 2014 Elsevier B.V. All rights reserved.

Therapist effects and IAPT Psychological Wellbeing Practitioners (PWPs): a multilevel modelling and mixed methods analysis.

PubMed

Green, Helen; Barkham, Michael; Kellett, Stephen; Saxon, David

2014-12-01

The aim of this research was (a) to determine the extent of therapist effects in Psychological Wellbeing Practitioners (PWPs) delivering guided self-help in IAPT services and (b) to identify factors that defined effective PWP clinical practice. Using patient (N = 1122) anxiety and depression outcomes (PHQ-9 and GAD-7), the effectiveness of N = 21 PWPs across 6 service sites was examined using multi-level modelling. PWPs and their clinical supervisors were also interviewed and completed measures of ego strength, intuition and resilience. Therapist effects accounted for around 9 per cent of the variance in patient outcomes. One PWP had significantly better than average outcomes on both PHQ-9 and GAD-7 while 3 PWPs were significantly below average on the PHQ-9 and 2 were below average on the GAD-7. Computed PWP ranks identified quartile clusters of the most (N = 5) and least (N = 5) effective PWPs. More effective PWPs generated higher rates of reliable and clinically significant change and displayed greater resilience, organisational abilities, knowledge and confidence. Study weaknesses are identified and methodological considerations for future studies examining therapist effects in low intensity cognitive behaviour therapy are provided. Copyright © 2014 Elsevier Ltd. All rights reserved.

The American Society for Clinical Pathology resident in-service examination: does resident performance provide insight into the effectiveness of clinical pathology education?

PubMed

McKenna, Barbara J

2007-06-01

The resident in-service examination in pathology is an in-training exercise that is taken by virtually all pathology residents in the United States as well as by some participants in Canada, Ireland, and Lebanon. Although all of the anatomic pathology topics in the examination, with only one exception-forensic pathology, show significant improvement in scores over the 4 years of residency training, three areas of clinical pathology training (laboratory administration, clinical chemistry, and microbiology) show significantly lower improvement in performance over the years of residency training. By contrast, transfusion medicine, hematopathology and the special topics section of the examination all demonstrate improved performance by residents over time. While the reason behind these differences must remain speculative at this time, these findings suggest that measures to improve effectiveness in clinical pathology training might be suggested by examining the differences between residency training practices between higher and lower performing areas of clinical pathology.

Selexipag in Pulmonary Arterial Hypertension: Most Updated Evidence From Recent Preclinical and Clinical Studies.

PubMed

Ghosh, Raktim K; Ball, Somedeb; Das, Avash; Bandyopadhyay, Dhrubajyoti; Mondal, Samhati; Saha, Debjit; Gupta, Anjan

2017-05-01

Pulmonary arterial hypertension (PAH) is a relatively rare disease that, due to its chronic nature, has always been difficult to treat effectively. Selexipag is an oral prostacyclin (PGI 2 ) agonist that was approved by US Food and Drug Administration (US FDA) in December 2015 for the treatment of PAH. After its success in phase 1 and phase 2 clinical trials regarding the convenient oral twice-daily dosing and low side-effect profile, selexipag raised the hope of controlling the disease progression in PAH patients. In the recently completed multicentered phase 3 study (GRIPHON), selexipag has been shown to reduce death and hospitalization due to PAH significantly, an effect that was consistent across different ranges of maintenance dose. In the same study selexipag use was also associated with an increase in 6-minute walk distance (a measure of symptom severity) from baseline, but no significant improvement in all-cause mortality could be observed. The results of the ongoing phase 3 studies (TRITON and TRANSIT-1) are expected to throw some more light on the safety and efficacy of this novel molecule across various treatment scenarios. Hence, our article aims to summarize all the available information from preclinical and clinical studies published to date on the pharmacodynamics, pharmacokinetics, efficacy, safety (in general and in scenarios such as hepatic and renal function impairment), significant drug interactions (with warfarin and antiretroviral drugs), and clinical significance of oral selexipag in patients with PAH. © 2016, The American College of Clinical Pharmacology.

Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.

PubMed

Ciudad, Antonio; Gutiérrez, Miguel; Cañas, Fernando; Gibert, Juan; Gascón, Josep; Carrasco, José-Luis; Bobes, Julio; Gómez, Juan-Carlos; Alvarez, Enrique

2005-07-01

This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy. 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (p<0.0001). Response rate was significantly higher in the OGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

Effects of additional team-based learning on students' clinical reasoning skills: a pilot study.

PubMed

Jost, Meike; Brüstle, Peter; Giesler, Marianne; Rijntjes, Michel; Brich, Jochen

2017-07-14

In the field of Neurology good clinical reasoning skills are essential for successful diagnosing and treatment. Team-based learning (TBL), an active learning and small group instructional strategy, is a promising method for fostering these skills. The aim of this pilot study was to examine the effects of a supplementary TBL-class on students' clinical decision-making skills. Fourth- and fifth-year medical students participated in this pilot study (static-group comparison design). The non-treatment group (n = 15) did not receive any additional training beyond regular teaching in the neurology course. The treatment group (n = 11) took part in a supplementary TBL-class optimized for teaching clinical reasoning in addition to the regular teaching in the neurology course. Clinical decision making skills were assessed using a key-feature problem examination. Factual and conceptual knowledge was assessed by a multiple-choice question examination. The TBL-group performed significantly better than the non-TBL-group (p = 0.026) in the key-feature problem examination. No significant differences between the results of the multiple-choice question examination of both groups were found. In this pilot study participants of a supplementary TBL-class significantly improved clinical decision-making skills, indicating that TBL may be an appropriate method for teaching clinical decision making in neurology. Further research is needed for replication in larger groups and other clinical fields.

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.

Effect of therapeutic ultrasound intensity on subcutaneous tissue temperature and ulnar nerve conduction velocity.

PubMed

Kramer, J F

1985-02-01

Twenty subjects completed 5 min. periods of sonation, at each of six US intensities, over the ulnar nerve in the proximal forearm. All posttreatment NCV's differed significantly from the respective pretreatment velocities. The immediate posttreatment NCV associated with placebo US was significantly (p less than 0.01) less than that observed immediately pretreatment (2.81 m/s), while the five clinical US intensities produced significantly increased immediate posttreatment velocities: 0.5 w/cm2 (2.23 m/s) at (p less than 0.05), and 1.0 w/cm2 (2.78 m/s), 1.5 w/cm2 (3.15 m/s), 2.0 w/cm2 (4.47 m/s) and 2.5 w/cm2 (2.97 m/s) at (p less than 0.01). The posttreatment velocities associated with the five clinical intensities were all significantly greater (p less than 0.01) than that associated with placebo US. Subcutaneous tissue temperatures were directly related to the intensity of US. Not until US intensity had reached 1.5 w/cm2 did the heating effect of US negate the cooling effect of the US transmission gel, to produce significantly increased subcutaneous tissue temperatures after 5 min. sonation. The decreased ulnar motor NCV's associated with placebo US are attributed to the cooling effect of the US transmission gel. The increased ulnar motor NCV's associated with the clinical intensities of US are attributed to the deep heating effect of US. The breakdown of this linear relationship at 2.5 w/cm2 intensity suggests that at this point heating on the nerve and/or the mechanical effects of US were of sufficient magnitude so as to limit the increase in conduction velocity. Sonation over an area of approximately 4.5 times the soundhead for 5 min., along the proximal forearm, at clinical intensities did not have a bipositive effect on motor NCV.

Effects of structured written feedback by cards on medical students' performance at Mini Clinical Evaluation Exercise (Mini-CEX) in an outpatient clinic.

PubMed

Haghani, Fariba; Hatef Khorami, Mohammad; Fakhari, Mohammad

2016-07-01

Feedback cards are recommended as a feasible tool for structured written feedback delivery in clinical education while effectiveness of this tool on the medical students' performance is still questionable.  The purpose of this study was to compare the effects of structured written feedback by cards as well as verbal feedback versus verbal feedback alone on the clinical performance of medical students at the Mini Clinical Evaluation Exercise (Mini-CEX) test in an outpatient clinic. This is a quasi-experimental study with pre- and post-test comprising four groups in two terms of medical students' externship. The students' performance was assessed through the Mini-Clinical Evaluation Exercise (Mini-CEX) as a clinical performance evaluation tool. Structured written feedbacks were given to two experimental groups by designed feedback cards as well as verbal feedback, while in the two control groups feedback was delivered verbally as a routine approach in clinical education. By consecutive sampling method, 62 externship students were enrolled in this study and seven students were excluded from the final analysis due to their absence for three days. According to the ANOVA analysis and Post Hoc Tukey test,  no statistically significant difference was observed among the four groups at the pre-test, whereas a statistically significant difference was observed between the experimental and control groups at the post-test  (F = 4.023, p =0.012). The effect size of the structured written feedbacks on clinical performance was 0.19. Structured written feedback by cards could improve the performance of medical students in a statistical sense. Further studies must be conducted in other clinical courses with longer durations.

Effect of Ranirestat on Sensory and Motor Nerve Function in Japanese Patients with Diabetic Polyneuropathy: A Randomized Double-Blind Placebo-Controlled Study

PubMed Central

Satoh, Jo; Kohara, Nobuo; Sekiguchi, Kenji; Yamaguchi, Yasuyuki

2016-01-01

We conducted a 26-week oral-administration study of ranirestat (an aldose reductase inhibitor) at a once-daily dose of 20 mg to evaluate its efficacy and safety in Japanese patients with diabetic polyneuropathy (DPN). The primary endpoint was summed change in sensory nerve conduction velocity (NCV) for the bilateral sural and proximal median sensory nerves. The sensory NCV was significantly (P = 0.006) improved by ranirestat. On clinical symptoms evaluated with the use of modified Toronto Clinical Neuropathy Score (mTCNS), obvious efficacy was not found in total score. However, improvement in the sensory test domain of the mTCNS was significant (P = 0.037) in a subgroup of patients diagnosed with neuropathy according to the TCNS severity classification. No clinically significant effects on safety parameters including hepatic and renal functions were observed. Our results indicate that ranirestat is effective on DPN (Japic CTI-121994). PMID:26881251

Efficacy of a botanical preparation for the intramammary treatment of clinical mastitis on an organic dairy farm

PubMed Central

Pinedo, Pablo; Karreman, Hubert; Bothe, Hans; Velez, Juan; Risco, Carlos

2013-01-01

The objective was to evaluate the efficacy of a botanical product (PHYTO-MAST®) for the intra-mammary treatment of clinical mastitis (CM) in dairy cows managed in an organic system. The study involved 194 naturally occurring cases of clinical mastitis. Treatment was applied every 12 hours for 3 days and cows were evaluated for clinical cure starting on day 4. Outcomes of interest consisted of mastitis resolution at day 4, time to resolution, somatic cell score (SCS) after recovery, and bacteriological cure at 14 and 28 d after treatment. There was no significant effect on clinical mastitis resolution at day 4 for treatment compared with the control group. However, there was a faster recovery for the treatment group compared to the control group with median intervals from end of treatment to recovery of 4.6 d and 6.5 d, respectively. There was no effect on the probability of a SCS < 4 (200 000 SC/mL) after treatment. No significant effects were found for treatment on bacteriological cure at days 14 and 28. PMID:24155432

Clinical significance of achieving a flexion limitation with a tension band system in grade 1 degenerative spondylolisthesis: a minimum 5-year follow-up.

PubMed

Lee, Sang-Ho; Lee, Ho-Yeon; Baek, Oon Ki; Bae, Jun Seok; Yoo, Seung-Hwa; Lee, June-Ho

2015-03-15

Retrospective clinical study. To evaluate the effect of the limitation of flexion rotation clinically and radiologically after interspinous soft stabilization using a tension band system in grade 1 degenerative spondylolisthesis. Although several studies have been published on the clinical effects of limiting rotatory motion using tension band systems, which mainly targets the limitation of flexion rather than that of extension, they were confined to the category of pedicle screw-based systems, revealing inconsistent long-term outcomes. Sixty-one patients with a mean age of 60.6 years (range, 28-76 yr) who underwent interspinous soft stabilization after decompression for grade 1 degenerative spondylolisthesis with stenosis between 2002 and 2004 were analyzed. At follow-up, the patients were divided into 2 groups on the basis of their achievement or failure to achieve flexion limitation. The clinical and radiological findings were analyzed. A multiple linear regression analysis was performed to determine the prognostic factors for surgical outcomes. At a mean follow-up duration of 72.5 months (range, 61-82 mo), 51 patients were classified into the flexion-limited group and 10 into the flexion-unlimited group. Statistically significant improvements were noted only in the flexion-limited group in all clinical scores. In the flexion-unlimited group, there were significant deteriorations in flexion angle (P = 0.009), axial thickness of the ligamentum flavum (P = 0.013), and the foraminal cross-sectional area (P = 0.011), resulting in significant intergroup differences. The preoperative extension angle was identified as the most influential variable for the flexion limitation and the clinical outcomes. The effects of the limitation of flexion rotation achieved through interspinous soft stabilization using a tension band system after decompression were related to the prevention of late recurrent stenosis and resultant radicular pain caused by flexion instability. The extension potential at the index level was recognized as a major prognostic factor that can predict the flexion limitation and the clinical results. 4.

Blood Group Antibodies in Obstetrics

PubMed Central

Neurath, Doris; Nimrod, Carl

1991-01-01

A retrospective survey of the frequency, nature, and effect of blood group antibodies on obstetrical outcome was conducted over 4 years in a large community hospital. A total of 189 antibodies were identified in 165 patients. Twenty clinically significant outcomes occurred, including three stillbirths. All clinically significant cases of hemolytic disease of the newborn were caused by Rh antibodies. PMID:21229104

Individual and group cognitive processing therapy: Effectiveness across two veterans affairs posttraumatic stress disorder treatment clinics.

PubMed

Lamp, Kristen E; Avallone, Kimberly M; Maieritsch, Kelly P; Buchholz, Katherine R; Rauch, Sheila A M

2018-05-14

In accordance with Veterans Affairs (VA) policy, VA posttraumatic stress disorder (PTSD) clinics offer evidence-based treatments including cognitive processing therapy (CPT). To facilitate access to care, CPT is offered in both group and individual formats in many VA PTSD clinics. Group and individual delivery of CPT have been directly compared in active duty samples, but these findings have not been extended to VA populations. The present article directly compares the effectiveness of group and individual CPT with a written trauma account (CPT+A) across two VA PTSD clinics. Veterans (N = 465) completed initial evaluations and enrolled in either group CPT+A (N = 146) or individual CPT+A (N = 319). Self-report measures of PTSD and depression symptoms were collected at pre-, mid-, and posttreatment; combined across treatment sites; and analyzed using hierarchical linear modeling. PTSD and depression symptoms reduced significantly over the course of group and individual CPT+A. Medium treatment effects were found for group CPT+A (d = .66 for PTSD, d = .68 for depression), and large treatment effects were found for individual CPT+A (d = .96 for PTSD, d = .79 for depression). Individual CPT+A led to significantly greater PTSD and depression symptom reduction than group CPT+A, indicating that in VA outpatient PTSD clinic settings, individual CPT+A may be a more effective approach than group CPT-A. In addition, PTSD symptoms reduced significantly more for Caucasian veterans than for African American veterans during CPT+A, indicating the importance of providing culturally competent trauma-focused care. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Integration of biomimicry and nanotechnology for significantly improved detection of circulating tumor cells (CTCs).

PubMed

Myung, Ja Hye; Park, Sin-Jung; Wang, Andrew Z; Hong, Seungpyo

2017-12-13

Circulating tumor cells (CTCs) have received a great deal of scientific and clinical attention as a biomarker for diagnosis and prognosis of many types of cancer. Given their potential significance in clinics, a variety of detection methods, utilizing the recent advances in nanotechnology and microfluidics, have been introduced in an effort of achieving clinically significant detection of CTCs. However, effective detection and isolation of CTCs still remain a tremendous challenge due to their extreme rarity and phenotypic heterogeneity. Among many approaches that are currently under development, this review paper focuses on a unique, promising approach that takes advantages of naturally occurring processes achievable through application of nanotechnology to realize significant improvement in sensitivity and specificity of CTC capture. We provide an overview of successful outcome of this biomimetic CTC capture system in detection of tumor cells from in vitro, in vivo, and clinical pilot studies. We also emphasize the clinical impact of CTCs as biomarkers in cancer diagnosis and predictive prognosis, which provides a cost-effective, minimally invasive method that potentially replaces or supplements existing methods such as imaging technologies and solid tissue biopsy. In addition, their potential prognostic values as treatment guidelines and that ultimately help to realize personalized therapy are discussed. Copyright © 2017. Published by Elsevier B.V.

Assessment of statistical significance and clinical relevance.

PubMed

Kieser, Meinhard; Friede, Tim; Gondan, Matthias

2013-05-10

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

Undergraduate nursing students' perceptions of the effectiveness of clinical teaching behaviours in Malaysia: A cross-sectional, correlational survey.

PubMed

Ludin, Salizar Mohamed; Fathullah, Nik Mohamed Nik

2016-09-01

Clinical teachers are a critical determinant of the quality of nursing students' clinical learning experiences. Understanding students' perceptions of clinical teachers' behaviours can provide the basis for recommendations that will help improve the quality of clinical education in clinical settings by developing better clinical teachers. To understand clinical teaching behaviours and their influence on students' learning from the perspective of undergraduate nursing students. A cross-sectional, correlational survey. A nursing faculty in Kuantan, Pahang, Malaysia. A sample of 120/154 (78%) students from Year 2-Year 4 were recruited according to set criteria. A self-administered questionnaire was employed to collect demographic data, and students' perceptions of clinical teaching behaviours and their impact on learning using the Nursing Clinical Teaching Effectiveness Inventory (NCTEI). Year 3 and 4 students perceived faculty clinical teaching behaviours positively. There was a significant association between clinical teaching behaviours and their influence on students' clinical learning. Teachers' competence rated as the most significant influential factor, while teachers' personality rated as least influential. Participants were able to identify the attributes of good clinical teachers and which attributes had the most influence on their learning. Overall, they perceived their teachers as providing good clinical teaching resulting in good clinical learning. Novice clinical teachers and nursing students can use this positive association between teaching behaviours and quality of clinical learning as a guide to clinical teaching and learning. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Two-Week Psychosocial Intervention Reduces Future Aggression and Incarceration in Clinically Aggressive Juvenile Offenders.

PubMed

Kendall, Ashley D; Emerson, Erin M; Hartmann, William E; Zinbarg, Richard E; Donenberg, Geri R

2017-12-01

There is a largely unmet need for evidence-based interventions that reduce future aggression and incarceration in clinically aggressive juvenile offenders serving probation. We addressed this gap using a group randomized controlled trial. Offenders both with and without clinical aggression were included, enabling comparison of intervention effects. Juveniles 13 to 17 years old (N = 310, mean = 16 years, 90% African-American, 66% male) on probation were assigned to a 2-week intervention targeting psychosocial factors implicated in risky behavior (e.g., learning strategies to manage "hot" emotions that prompt risk taking) or to an equally intensive health promotion control. Participants completed aggression measures at baseline, 6-, and 12-month follow-up and reported on incarceration at 12 months. Spline regression tested symptom change. Among clinically aggressive offenders (n = 71), the intervention arm showed significantly greater reductions in aggression over the first 6 months compared with controls. Juveniles from the intervention no longer met clinical criteria, on average, but clinically significant symptoms persisted in the control group. By 12 months, participants from the intervention appeared to maintain treatment gains, but their symptom levels no longer differed significantly from those in the control. However, the intervention group was nearly 4 times less likely than controls to report incarceration. Intervention effects were significantly stronger for offenders with clinical than with nonclinical (n = 239) baseline aggression. A 2-week intervention expedited improvements in aggression and reduced incarceration in clinically aggressive juvenile offenders. The findings underscore the importance of directing intervention resources to the most aggressive youth. Clinical trial registration information-PHAT Life: Preventing HIV/AIDS Among Teens in Juvenile Justice (PHAT Life); http://clinicaltrials.gov/; NCT02647710. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Early exposure to probiotics in a canine model of atopic dermatitis has long-term clinical and immunological effects.

PubMed

Marsella, Rosanna; Santoro, Domenico; Ahrens, Kim

2012-04-15

Probiotics modulate the immune response and may have protective effects against atopic dermatitis (AD). Clinical trials using dogs with spontaneous disease are limited by confounding factors such as different diets, environments and sensitizations while a more controlled evaluation is possible using experimental models. A validated model of canine AD showed that early exposure to Lactobacillus rhamnosus GG (LGG) significantly decreases allergen-specific IgE and partially prevents AD in the first 6 months of life. This study is a follow-up three years after discontinuation of LGG. Clinical signs were evaluated after allergen challenge with ragweed, timothy, Dermatophagoides farinae. Allergen-specific IgE, IL-10 and TGF-β were measured on the 1st day of challenge, before allergen exposure. Normal dogs were included as controls. Analyses included seven dogs in the non-probiotic and nine in the probiotic litter. For clinical scores, a 2-Group × 9-Time Analysis of Variance showed significant effects of group (p=0.0003, probiotic

Remote preconditioning and major clinical complications following adult cardiovascular surgery: systematic review and meta-analysis.

PubMed

Healy, D A; Khan, W A; Wong, C S; Moloney, M Clarke; Grace, P A; Coffey, J C; Dunne, C; Walsh, S R; Sadat, U; Gaunt, M E; Chen, S; Tehrani, S; Hausenloy, D J; Yellon, D M; Kramer, R S; Zimmerman, R F; Lomivorotov, V V; Shmyrev, V A; Ponomarev, D N; Rahman, I A; Mascaro, J G; Bonser, R S; Jeon, Y; Hong, D M; Wagner, R; Thielmann, M; Heusch, G; Zacharowski, K; Meybohm, P; Bein, B; Tang, T Y

2014-09-01

A number of 'proof-of-concept' trials suggest that remote ischaemic preconditioning (RIPC) reduces surrogate markers of end-organ injury in patients undergoing major cardiovascular surgery. To date, few studies have involved hard clinical outcomes as primary end-points. Randomised clinical trials of RIPC in major adult cardiovascular surgery were identified by a systematic review of electronic abstract databases, conference proceedings and article reference lists. Clinical end-points were extracted from trial reports. In addition, trial principal investigators provided unpublished clinical outcome data. In total, 23 trials of RIPC in 2200 patients undergoing major adult cardiovascular surgery were identified. RIPC did not have a significant effect on clinical end-points (death, peri-operative myocardial infarction (MI), renal failure, stroke, mesenteric ischaemia, hospital or critical care length of stay). Pooled data from pilot trials cannot confirm that RIPC has any significant effect on clinically relevant end-points. Heterogeneity in study inclusion and exclusion criteria and in the type of preconditioning stimulus limits the potential for extrapolation at present. An effort must be made to clarify the optimal preconditioning stimulus. Following this, large-scale trials in a range of patient populations are required to ascertain the role of this simple, cost-effective intervention in routine practice. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

[The effects of case-based learning using video on clinical decision making and learning motivation in undergraduate nursing students].

PubMed

Yoo, Moon-Sook; Park, Jin-Hee; Lee, Si-Ra

2010-12-01

The purpose of this study was to examine the effects of case-base learning (CBL) using video on clinical decision-making and learning motivation. This research was conducted between June 2009 and April 2010 as a nonequivalent control group non-synchronized design. The study population was 44 third year nursing students who enrolled in a college of nursing, A University in Korea. The nursing students were divided into the CBL and the control group. The intervention was the CBL with three cases using video. The controls attended a traditional live lecture on the same topics. With questionnaires objective clinical decision-making, subjective clinical decision-making, and learning motivation were measured before the intervention, and 10 weeks after the intervention. Significant group differences were observed in clinical decision-making and learning motivation. The post-test scores of clinical decision-making in the CBL group were statistically higher than the control group. Learning motivation was also significantly higher in the CBL group than in the control group. These results indicate that CBL using video is effective in enhancing clinical decision-making and motivating students to learn by encouraging self-directed learning and creating more interest and curiosity in learning.

Travel distance as factor in follow-up visit compliance in postlaparoscopic adjustable gastric banding population.

PubMed

DeNino, Walter F; Osler, Turner; Evans, Ellen G; Forgione, Patrick M

2010-01-01

Despite the 2008 "American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic and Bariatric Surgery Medical Guidelines for Clinical Practice for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient," consensus does not exist for postoperative care in laparoscopic adjustable gastric banding (LAGB) patients (grade D evidence). It has been suggested that regular follow-up is related to better outcomes, specifically greater weight loss. The aim of the present study was to investigate the effects of travel distance to the clinic on the adherence to follow-up visits and weight loss in a cohort of LAGB patients in the setting of a rural, university-affiliated teaching hospital in the United States. A retrospective chart review was performed of all consecutive LAGB patients for a 1-year period. Linear regression analysis was used to identify the relationships between appointment compliance and the distance traveled and between the amount of weight loss and the distance traveled. Linear regression analysis was performed to investigate the effect of the travel distance to the clinic on the percentage of follow-up visits postoperatively. This effect was not significant (P = .4). Linear regression analysis was also performed to elucidate the effect of the travel distance to the clinic on the amount of weight loss. This effect was significant (P = .04). The travel distance to the clinic did not seem to be a significant predictor of compliance in a cohort of LAGB patients with ≤ 1 year of follow-up in a rural setting. However, a weak relationship was found between the travel distance to the clinic and weight loss, with patients who traveled further seeming to lose slightly more weight. Copyright © 2010 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

[Studies on the adverse effects of fluvoxamine treatment in children with autistic disorder: correlation with genetic polymorphism in serotonin related genes].

PubMed

Sugie, Yoko; Sugie, Hideo; Fukuda, Tokiko; Ito, Masataka; Ohzeki, Takehiko

2003-05-01

Selective serotonin re-uptake inhibitors (SSRIs) have recently been applied to the children with autistic disorder. To create better treatment, we studied here clinical adverse effects of fluvoxamine and correlated them with genetic polymorphism of two genes, the promoter region of serotonin transporter gene (5-HTTLPR) and serotonin 2A receptor gene (5-HT2AR). Twenty-eight subjects, consisting of 23 boys and 5 girls, aged from 3 to 18 years old diagnosed as having autistic disorder were analyzed during fluvoxamine administration. The dosages and duration of fluvoxamine treatment are 1.5 to 3 mg/kg/day and 2 weeks to 17 months (mean 7.9 months), respectively. There were several clinical adverse effects such as sleep disturbance in 9 cases, climb up to high places in 8, gastrointestinal symptoms in 6, hyperactivities in 5, excitement in 4, general fatigability in 2 and urticaria in 1. Medication was discontinued in 2 patients with fatigability and 1 with sleep disturbance, diarrhea and poor appetite. There was no significant correlation between genetic polymorphism in 5-HTTLPR and the occurrence of clinical adverse effects of fluvoxamine. However hyperactivity was significantly more frequent in the subjects with 102T/102T polymorphism of 5-HT2AR, and patients with sleep disturbance were significantly less frequent in the subjects with 102C/102C polymorphism. We conclude that the clinical adverse effects such as climb up to high places and hyperactivity during fluvoxamine treatment may be relatively specific in children, and that genetic polymorphism of 5-HT2AR may be related to the appearance of clinical adverse effects.

The effect of cactus pear (Opuntia ficus-indica) on body weight and cardiovascular risk factors: a systematic review and meta-analysis of randomized clinical trials.

PubMed

Onakpoya, Igho J; O'Sullivan, Jack; Heneghan, Carl J

2015-05-01

Hundreds of dietary supplements are currently marketed as weight loss supplements. However, the advertised health claims of effectiveness for most of these have not been proven. The aim of this study was to critically appraise and evaluate the evidence for effectiveness of cactus pear, Opuntia ficus-indica (OFI), using data from published randomized clinical trials. We conducted electronic searches in Medline, Embase, Amed, Cinahl, and the Cochrane Library. No restrictions on age, time, or language were imposed. The risk for bias in the studies included was assessed using the Cochrane Collaboration criteria. Two reviewers independently determined the eligibility of included studies, assessed reporting quality, and extracted data. We identified seven eligible studies, of which five were included. The studies varied in design and reporting quality. Meta-analysis revealed a nonsignificant difference in body weight between OFI and controls (mean difference = -0.83 kg; 95% confidence interval, -2.49 to 0.83; I(2) = 93%). Significant reductions in body mass index, percentage body fat, systolic and diastolic blood pressures, and total cholesterol were observed. Adverse events included gastric intolerance and flu symptoms. The evidence from randomized clinical trials does not indicate that supplementation with OFI generates statistically significant effects on body weight. Consumption of OFI can cause significant reductions in percentage body fat, blood pressure, and total cholesterol. Few clinical trials evaluating the effects of OFI have been published. They vary in design and methodology, and are characterized by inconsistent quality of reporting. Further clinical trials evaluating the effects of OFI on body composition and metabolic parameters are warranted. Copyright © 2015 Elsevier Inc. All rights reserved.

Testing the effects of educational toilet posters: a novel way of reducing haemolysis of blood samples within ED.

PubMed

Corkill, David

2012-02-01

Haemolysed blood samples are an unnecessary burden on Emergency Departments (ED) as they increase workloads and drive down efficiencies. Little empirical data exists that demonstrates the effectiveness of educational posters displayed in staff toilet cubicles. This study explored the impact educational toilet posters have on reducing haemolysis rates within the ED. A time series study of the clinical effect of educational toilet posters on reducing haemolysis rates throughout a 12 month period at the Gold Coast Hospital ED was undertaken. The GCH ED is a tertiary emergency service that has approximately 66,000 patient presentations per year. Data was collected prospectively. Analysis was undertaken to investigate the effects on total number of haemolysed samples and those clinically significant samples with a haemolytic index >3. Further investigation explored the specific effects on medical and nursing staff. Analysis undertaken using an independent t-test found that the pre-intervention data demonstrates a medium haemolysis rate of 4.92% (SD=1.04). This is a statistically significantly different (t=3.56, df=50, p=0.001) from the median post intervention data of 3.95% (SD=0.84). The difference of 0.97% (95%CI=0.42, 1.52) represents a 19.72% reduction in clinically significant haemolysed samples over the study period. This study reveals that the use of educational toilet posters had a positive impact on reducing the rates of haemolysed samples collected within the ED. This simple and cost effective educational initiative changed the behaviour of clinical staff. Further investigation is warranted to examine the impact of educational toilet posters on additional clinical scenarios. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

PubMed

Guerrero, D; Garrigue, E

2017-01-01

Atopic dermatitis (AD) is the most frequent disease treated at the Avène hydrotherapy center. Children represent a large part of the population due to the high prevalence of AD in early childhood. Avène thermal spring water (ATSW) has been known for its therapeutic effects since the middle of the 18 th century. It has been greatly studied over the last decades, with a comprehensive fundamental, pharmaco-clinical and clinical approach. Cohort studies using the Scoring Atopic Dermatitis (SCORAD) clinical score and the Dermatology Life Quality Index (DLQI) or the Children's Dermatology Life Quality Index [CDLQI]) quality of life scores, allowed to confirm the clinical results obtained from the previous studies. These results were corroborated by clinical trials conducted in atopic patients outside the Avène hydrotherapy center, allowing to demonstrate the specific effect of the ATSW. Pharmacological and pharmaco-clinical studies evidenced several effects that could explain the healing effect of ATSW: effect on histamine release, anti-inflammatory effects on standardized models, immuno-modulation of some cytokines involved in DA physiopathology (interferon [INF], interleukin 2 and 4 [IL-2, IL-4]), improvement of keratinocyte differentiation, effect on the skin microbioma by promoting the development of a diversified non-pathogenic flora. In addition, an original microorganism, Aquaphilus dolomiae, never described in another medium, has very recently been identified in the ATSW. Aquaphilus dolomiae is responsible for significant pharmacological activities on inflammation, pruritus and enhancement of innate immunity. This set of works confirms the medical significance of the hydrotherapy which should be considered as a complementary care in the sometimes difficult management of AD. © 2017 Elsevier Masson SAS. Tous droits réservés.

Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis.

PubMed

Jakobsen, Janus Christian; Katakam, Kiran Kumar; Schou, Anne; Hellmuth, Signe Gade; Stallknecht, Sandra Elkjær; Leth-Møller, Katja; Iversen, Maria; Banke, Marianne Bjørnø; Petersen, Iggiannguaq Juhl; Klingenberg, Sarah Louise; Krogh, Jesper; Ebert, Sebastian Elgaard; Timm, Anne; Lindschou, Jane; Gluud, Christian

2017-02-08

The evidence on selective serotonin reuptake inhibitors (SSRIs) for major depressive disorder is unclear. Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo, 'active' placebo, or no intervention in adult participants with major depressive disorder. We searched for eligible randomised clinical trials in The Cochrane Library's CENTRAL, PubMed, EMBASE, PsycLIT, PsycINFO, Science Citation Index Expanded, clinical trial registers of Europe and USA, websites of pharmaceutical companies, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency until January 2016. All data were extracted by at least two independent investigators. We used Cochrane systematic review methodology, Trial Sequential Analysis, and calculation of Bayes factor. An eight-step procedure was followed to assess if thresholds for statistical and clinical significance were crossed. Primary outcomes were reduction of depressive symptoms, remission, and adverse events. Secondary outcomes were suicides, suicide attempts, suicide ideation, and quality of life. A total of 131 randomised placebo-controlled trials enrolling a total of 27,422 participants were included. None of the trials used 'active' placebo or no intervention as control intervention. All trials had high risk of bias. SSRIs significantly reduced the Hamilton Depression Rating Scale (HDRS) at end of treatment (mean difference -1.94 HDRS points; 95% CI -2.50 to -1.37; P < 0.00001; 49 trials; Trial Sequential Analysis-adjusted CI -2.70 to -1.18); Bayes factor below predefined threshold (2.01*10 -23 ). The effect estimate, however, was below our predefined threshold for clinical significance of 3 HDRS points. SSRIs significantly decreased the risk of no remission (RR 0.88; 95% CI 0.84 to 0.91; P < 0.00001; 34 trials; Trial Sequential Analysis adjusted CI 0.83 to 0.92); Bayes factor (1426.81) did not confirm the effect). SSRIs significantly increased the risks of serious adverse events (OR 1.37; 95% CI 1.08 to 1.75; P = 0.009; 44 trials; Trial Sequential Analysis-adjusted CI 1.03 to 1.89). This corresponds to 31/1000 SSRI participants will experience a serious adverse event compared with 22/1000 control participants. SSRIs also significantly increased the number of non-serious adverse events. There were almost no data on suicidal behaviour, quality of life, and long-term effects. SSRIs might have statistically significant effects on depressive symptoms, but all trials were at high risk of bias and the clinical significance seems questionable. SSRIs significantly increase the risk of both serious and non-serious adverse events. The potential small beneficial effects seem to be outweighed by harmful effects. PROSPERO CRD42013004420.

The effects of black pepper on the intestinal absorption and hepatic metabolism of drugs.

PubMed

Han, Hyo-Kyung

2011-06-01

There is currently a need for a better understanding of the mechanisms of food-drug interaction as well as the clinical implication to maximize the effectiveness and applicability of black pepper or its active component, piperine, as a bioavailability enhancer in the clinical arena. This review deals with the effects of black pepper and piperine on drug metabolizing enzymes as well as on intestinal drug absorption. The review provides the reader with a comprehensive update on the potential mechanisms and pharmacokinetic interactions of black pepper and piperine with co-administered medicines. The article also provides a comprehensive update on the current known issues with black pepper and piperine. The information provided is used to assess the clinical significance of black pepper and piperine and optimize their effectiveness as a bioavailability enhancer. For black pepper or piperine to be widely applicable in current medical practice, as a combination therapy, the clinical significance of food-drug interactions caused by concurrent use of black pepper or piperine should be carefully assessed with consideration for many compounding factors affecting the clinical outcome of pharmacokinetic interactions (e.g., dose, dosing regimen, genetic variation and species). Furthermore, the effective formulation strategy for the optimization of the pharmacokinetic characteristics of dietary components is crucial to improve their in vivo performance and ultimately maximize their effectiveness as a bioavailability enhancer.

Effects of enzyme-potentiated desensitization in the treatment of pollinosis: a double-blind placebo-controlled trial.

PubMed

Astarita, C; Scala, G; Sproviero, S; Franzese, A

1996-01-01

Several controlled clinical trials have shown that specific immunotherapy (SIT) using incremental injections of allergens can be effective in the treatment of allergic rhinitis and asthma. Nevertheless, the risk of side effects have led to some recommended limitations of SIT. Enzyme-potentiated desensitization (EPD) is a proposed method for immunotherapy with very low doses of mixed allergens plus beta-glucuronidase enzyme, for which irrelevant or no side effects have been claimed. The aim of this study was to determine the clinical efficacy of EPD in the treatment of pollinosis. A double-blind placebo-controlled trial of EPD among 20 patients sensitive to Parietaria and grass pollen was performed. All patients recorded daily symptom scores for nine months following a single intradermal injection of EPD or buffered saline received in February. Symptoms recorded were nasal itching and obstruction, sneezing, rhinorrhea, itchy eyes and excessive tear production. Moreover, total and specific lgE were measured and CD3+, CD4+ and CD8+ peripheral blood lymphocytes were counted at different times. In the same period, ten additional subjects, with an allergic clinical profile similar to the subjects admitted to the double-blind trial, were studied in an open clinical trial in order to evaluate the effects of EPD without enzyme using a mixture of allergens. Symptom scores were higher in the placebo group (p < 0.001), with a similar level of significance for both global symptom score and for each individual symptom. Active-treated patients had a significant post-treatment increase in the mean percentage of T-CD8+ peripheral blood cells and a significant post-seasonal decrease in the mean percentage of Parietaria specific lgE. On the contrary, placebo-treated patients had a borderline significant post-seasonal decrease in the mean percentage of CD8+ circulating cells and a significant seasonal increase in the mean percentage of Parietaria specific lgE with no significant post-seasonal decrease. Finally, clinical results of the mixture of allergens injection were similar to those of the placebo in the double-blind trial. EPD injection caused only an asymptomatic, local wheal and flare lasting about two hours. Two patients (20%) in the active-treated group experienced a delayed, mild, unusual headache lasting about two days. In conclusion, EPD is clinically effective in the treatment of pollinosis. Some immunological modifications observed in the EPD-treated patients suggest an EPD-induced enhancement of tolerogenic mechanisms like "immune deviation."

Third party laboratory data management: Perspective with respect to clinical data management.

PubMed

Johnson, Jasmin; Kanagali, Vishwanath; Prabu, D

2014-01-01

Third party lab vendor provides support for laboratory, biological samples analytics data, collected during the clinical trial. Third party laboratory data is considered to be very significant for the clinical trial data management process. Although outsourcing these services is considered to be advantageous for clinical trials, there are some risks involved. Hence, pharmaceutical companies proactively select, track and evaluate third party vendors on a regular basis before, during and after the completion of the contract. The data manager has a significant role to play in effective management of third party vendor data.

Third party laboratory data management: Perspective with respect to clinical data management

PubMed Central

Johnson, Jasmin; Kanagali, Vishwanath; Prabu, D.

2014-01-01

Third party lab vendor provides support for laboratory, biological samples analytics data, collected during the clinical trial. Third party laboratory data is considered to be very significant for the clinical trial data management process. Although outsourcing these services is considered to be advantageous for clinical trials, there are some risks involved. Hence, pharmaceutical companies proactively select, track and evaluate third party vendors on a regular basis before, during and after the completion of the contract. The data manager has a significant role to play in effective management of third party vendor data. PMID:24551587

Training and orthotic effects related to functional electrical stimulation of the peroneal nerve in stroke.

PubMed

Street, Tamsyn; Swain, Ian; Taylor, Paul

2017-01-31

To examine the evidence for a training effect on the lower limb of functional electrical stimulation. Cohort study. A total of 133 patients >6 months post-stroke. Training and orthotic effects were determined from walking speed over 10 m, associated minimal and substantial clinically important differences (i.e. >0.05 and >0.10 m/s), and Functional Ambulation Category (FAC), ranging from household walking to independent walking in the community. An overall significant (p < 0.01) training effect was found that was not a clinically important difference (0.02 m/s); however, "community" FAC (≥ 0.8 m/s) and "most limited community walkers" FAC (0.4-0.58 m/s), but not "household walkers" (< 0.4 m/s), benefitted from a clinically important difference. A highly significant (p< 0.001), substantial clinically important orthotic effect (0.10 m/s) was found. In terms of overall improvement of one or more FACs, 23% achieved this due to a training effect, compared with 43% due to an orthotic effect. The findings suggest that functional electrical stimulation provides a training effect in those who are less impaired. Further work, which optimizes the use of the device for restoration of function, rather than as an orthotic device, will provide greater clarity on the effectiveness of functional electrical stimulation for eliciting a training effect.

Levobupivacaine: a review of its use in regional anaesthesia and pain management.

PubMed

Sanford, Mark; Keating, Gillian M

2010-04-16

Levobupivacaine (Chirocaine) is a long-acting amide local anaesthetic that is effective when administered as an epidural, spinal, peripheral nerve or ocular block, or by topical application or local infiltration. In comparative trials, its clinical effects were not generally significantly different from those of bupivacaine or ropivacaine, although there was some variability in efficacy findings in different clinical populations. Levobupivacaine was generally well tolerated. Levobupivacaine provides effective anaesthesia and analgesia for a wide range of clinical populations and is a useful alternative to bupivacaine.

The Effectiveness of Ultra-Low Magnitude Reinforcers: Findings From a "Real-World" Application of Contingency Management.

PubMed

Kropp, Frankie; Lewis, Daniel; Winhusen, Theresa

2017-01-01

Research has consistently found contingency management (CM) to be an effective tool in increasing desired patient behaviors in substance use disorder (SUD) treatment. Despite the strong evidence for the effectiveness of this intervention, practical issues and the cost of implementing CM in treatment programs have been significant barriers to adoption. To evaluate the impact of a CM program designed and implemented by university-affiliated methadone clinic staff to increase patient group attendance. The CM program consisted of a weekly raffle for patients attending clinician-led group counseling and/or in-clinic Methadone Anonymous (MA) groups in which slips with patient ID#s were entered and one ID slip was drawn per week with a fee credit for a dose of methadone ($15) as the prize. The CM program continued for 12 months. Group attendance was tracked before, during, and after CM implementation as part of ongoing clinic service utilization monitoring. Following the implementation of CM, attendance at any clinician-led or MA groups increased significantly from baseline to month 1 (X 2 =5.78, p<0.05) but this increase was not sustained beyond month 6. Analysis of attendance by type of group revealed that clinician-led group attendance did not increase significantly but there was a significant increase in in-clinic MA group attendance from baseline to month 1 (X 2 =20.27, p<0.001), which was sustained through the 12-month implementation period (X 2 =11.21, p<0.001) and through 3 months post-implementation (X 2 =14.73; p<0.001). A low-cost, simple CM intervention implemented by clinic staff was associated with significant increases in the target behavior of increasing group attendance. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of weighted and un-weighted pendulum exercises on ultrasonographic acromiohumeral distance in patients with subacromial impingement syndrome.

PubMed

Akkaya, Nuray; Akkaya, Semih; Gungor, Harun R; Yaşar, Gokce; Atalay, Nilgun Simsir; Sahin, Fusun

2017-01-01

Although functional results of combined rehabilitation programs are reported, there have been no reports studying the effects of solo pendulum exercises on ultrasonographic measurements of acromiohumeral distance (AHD). To investigate the effects of weighted and un-weighted pendulum exercises on ultrasonographic AHD and clinical symptoms in patients with subacromial impingement syndrome. Patients with subacromial impingement syndrome were randomized to performing weighted (1.5 kilograms hand held dumbbell, N= 18) or un-weighted (free of weight, N= 16) pendulum exercises for 4 weeks, 3 sessions/day. Exercises were repeated for each direction of shoulder motion in each session (ten minutes). Clinical situation was evaluated by Constant score and Shoulder Pain Disability Index (SPADI). Ultrasonographic measurements of AHD at 0°, 30° and 60° shoulder abduction were performed. All clinical and ultrasonographic evaluations were performed at the beginning of the exercise program and at end of 4 weeks of exercise program. Thirty-four patients (23 females, 11 males; mean age 41.7 ± 8.9 years) were evaluated. Significant clinical improvements were detected in both exercise groups between pre and post-treatment evaluations (p < 0.05). There was no significant difference for pre and post-treatment AHD measurements at 0°, 30°, and 60° shoulder abduction between groups (p > 0.05). There was no significant difference for pre and post-treatment narrowing of AHD (narrowing of 0°-30°, and 0°-60°) between groups (p > 0.05). While significant clinical improvements were achieved with both weighted and un-weighted solo pendulum exercises, no significant difference was detected for ultrasonographic AHD measurements between exercise groups.

Topical isotretinoin for melasma in Thai patients: a vehicle-controlled clinical trial.

PubMed

Leenutaphong, V; Nettakul, A; Rattanasuwon, P

1999-09-01

Melasma is an acquired hyperpigmentary disorder commonly seen in Orientals. Recently it has been demonstrated that tretinoin (all-trans-retinoic acid) can produce significant clinical improvement of melasma. However, moderate cutaneous side effects (retinoid dermatitis) occurred in a number of patients. To investigate the efficacy of topical 0.05 per cent isotretinoin gel (Isotrex) in the treatment of melasma in Thai patients. Thirty patients with moderate to severe melasma entered a 40-week, randomized, vehicle-controlled clinical trial in which they applied either 0.05 per cent isotretinoin gel, or its vehicle base together with a broad spectrum sunscreen (SPF 28) daily to the entire face. They were evaluated clinically (using Melasma Area and Severity Index), and colorimetrically (using our Melasma Area and Melanin Index). After 40 weeks, the average MASI and MAMI scores of the isotretinoin-treated group decreased by 68.2 per cent and 47 per cent respectively, while the corresponding control scores declined 60 per cent and 34 per cent. There was no statistically significant difference between the isotretinoin and vehicle groups. When the MASI and MAMI scores of each visit were compared to their baseline data, a statistically significant reduction of the score was first noted at weeks 4 and 12 respectively. Lightening of melasma, as determined clinically (MASI score), correlated well with pigmentation measurements (MAMI score). Side effects were limited to a mild transient "retinoid dermatitis" occurring in 27 per cent of isotretinoin-treated patients. Daily use of broad spectrum sunscreen has a significant lightening effect on melasma in Thai patients. However, there was no statistically significant difference between the isotretinoin and vehicle-treated group.

[A clinical study of endodontic flare-ups].

PubMed

Yeh, S J; Lin, Y T; Lu, S Y

1994-06-01

The purpose of this study was to investigate the clinical variables influencing endodontic flare-ups. Three hundred and thirteen teeth receiving endodontic treatment at the Endodontic Department, Chang Gung Memorial Hospital were studied from December 1992 to February 1993. Among them, 21 teeth with significant pain and 9 with apical swelling were noted after the first appointment of treatment. Three teeth with persistent pain and one with apical swelling were also found one week after completion of endodontic therapy. The results showed significant improvement of clinical symptoms and signs one week after completion of endodontic treatment in comparison with pretreatment and after the first appointment (p < 0.025). The factors such as presence of pretreatment complaints, periapical lesions and vital pulp had significant effects on the incidence of endodontic flare-ups after the first appointment of treatment (P < 0.025). In contrast, patients' sex, the number of visits, and whether this was a retreatment case or not had no significant effect on the frequency of these endodontic flare-ups.

Randomized trial of harp therapy during in vitro fertilization-embryo transfer.

PubMed

Murphy, Erin M; Nichols, Jennifer; Somkuti, Steve G; Sobel, Michael; Braverman, Andrea; Barmat, Larry I

2014-04-01

This study evaluated whether harp therapy reduces levels of stress and improves clinical outcomes in patients undergoing embryo transfer. This prospective randomized trial enrolled 181 women undergoing embryo transfer, who were randomized to harp therapy during embryo transfer or standard treatment. Patients underwent standardized psychological testing and physiologic assessment of stress. The study was conducted in a reproductive medicine practice. No statistically significant differences were found in the heart and respiratory rates, nor was there a significant difference in event-based anxiety at baseline. Harp therapy had a significantly larger decrease in state anxiety from pre- to post-embryo transfer. Clinical pregnancy was 53% versus 48% for the harp therapy and standard treatment groups, respectively. Harp therapy decreases state, or event-based, anxiety, significantly lowering state scores posttransfer and having a positive effect on acute levels of stress. There was an increased pregnancy rate, but larger sample sizes are needed to evaluate whether harp therapy has an effect on clinical outcomes.

Silybin and the liver: From basic research to clinical practice

PubMed Central

Loguercio, Carmela; Festi, Davide

2011-01-01

Herbal products are increasingly used, mainly in chronic liver disease. Extracts of milk thistle, Silymarin and silybin, are the most prescribed natural compounds, with different indications, but with no definitive results in terms of clinical efficacy. This review analyzes the available studies on the effects of the purified product silybin, both as a free and a conjugated molecule, on liver cells or on experimentally induced liver damage, and in patients with liver disease. We searched PUBMED for articles pertaining to the in vitro and in vivo effects of silybin, its antifibrotic, anti-inflammatory, and antioxidant properties, as well as its metabolic effects, combined with the authors’ own knowledge of the literature. Results indicate that the bioavailability of silybin phytosome is higher than that of silymarin and is less influenced by liver damage; silybin does not show significant interactions with other drugs and at doses < 10 g/d has no significant side effects. Experimental studies have clearly demonstrated the antifibrotic, antioxidant and metabolic effects of silybin; previous human studies were insufficient for confirming the clinical efficacy in chronic liver disease, while ongoing clinical trials are promising. On the basis of literature data, silybin seems a promising drug for chronic liver disease. PMID:21633595

Concomitant Anticonvulsants With Bitemporal Electroconvulsive Therapy: A Randomized Controlled Trial With Clinical and Neurobiological Application.

PubMed

Rakesh, Gopalkumar; Thirthalli, Jagadisha; Kumar, Channaveerachari Naveen; Muralidharan, Kesavan; Phutane, Vivek H; Gangadhar, Bangalore N

2017-03-01

Electroconvulsive therapy (ECT) is an effective treatment for major affective disorders. The combined use of ECT and anticonvulsant mood stabilizers is a common clinical scenario. There is dearth of systematic studies on the use of this combination with regard to clinical or cognitive outcomes. We aimed to compare clinical improvement and cognitive adverse effects between patients who received only ECT versus those who received ECT and anticonvulsants. We hypothesized that improvement would be fastest in patients who received only ECT. We conducted a randomized controlled trial in which patients prescribed ECT while being treated with anticonvulsants were randomized into 3 groups: full-dose (FD), half-dose (HD), and stop anticonvulsant. A blind rater assessed clinical improvement in patients using rating scales [Young's Mania Rating Scale (YMRS) and Clinical Global Impression] for clinical improvement and cognitive adverse effects (Postgraduate Institute memory scale). Analysis was done using mixed-effects modeling to delineate differences in clinical and cognitive outcomes across the 3 arms of the study over the course of ECT. Of the 54 patients recruited, 36 patients went into treatment allocation arms per the initial randomization plan. The main anticonvulsants prescribed were sodium valproate and carbamazepine. Patients in the 3 groups were comparable on clinical features. The most common diagnosis was bipolar affective disorder-with current episode of mania. Overall, there was no difference across the 3 groups in final clinical outcome scores (YMRS and Clinical Global Impression) when analyzed as intention to treat (ITT) or "as treated." In both analyses, group × time interaction was significant when comparing trend of YMRS scores between the FD anticonvulsant group and the HD group from baseline to last ECT (P = 0.0435 in ITT and P = 0.0055 in as treated). Patients in the FD group improved faster than those in the HD group. There were no differences across the 3 groups with regard to their cognitive adverse effects in the ITT analysis; "as-treated analysis" showed the HD patients to have performed poorly on some domains. Seizure parameters showed no significant difference across the 3 groups. This is a preliminary prospective study examining whether coprescription of anticonvulsants with ECT affected clinical or cognitive outcomes. The most important takeaway point from this study is the significant reduction in YMRS scores when ECT was given with FD anticonvulsant compared with halving the dose (HD) of anticonvulsant. This difference was shown in both ITT and as-treated analysis. There is a need for more prospective studies to examine this clinical question.

Rivastigmine for Alzheimer's disease: Canadian interpretation of intermediate outcome measures and cost implications.

PubMed

Baladi, J F; Bailey, P A; Black, S; Bouchard, R W; Farcnik, K D; Gauthier, S; Kertesz, A; Mohr, E; Robillard, A

2000-12-01

Clinical studies have shown that patients with Alzheimer's disease (AD) who are treated with rivastigmine have statistically significantly better scores on 5 scales used to assess AD than control patients receiving placebo. However, the clinical meaning and cost implications of these differences are not clear. The purpose of this study was to assess the clinical meaning and cost implications of statistically significant results obtained in clinical trials of rivastigmine for the treatment of AD. Potential cost implications for the health care system, caregivers, and society are considered. Data on clinical effects of rivastigmine were obtained from published North American and European clinical studies of patients with mild to moderately severe AD receiving rivastigmine 6 to 12 mg/d (n = 828) or placebo (n = 647). Differences in scores on the Alzheimer's Disease Assessment Scale-Cognitive Function, Clinician's Interview-Based Impression of Change with both clinical and caregiver information considered, Progressive Deterioration Scale, Mini-Mental State Examination (MMSE), and Global Deterioration Scale were assessed. A convenience panel of 9 Canadian specialists experienced in the treatment of AD provided their opinions on the clinical importance of the trial results. Chart review was performed to identify specific behaviors that improved, and cost implications of improvements were assessed. The panel determined that statistically significant differences in scores on all scales except the MMSE were likely associated with functional or cognitive differences that were clinically relevant for patients, reflecting stabilization that would have beneficial consequences for caregivers and health care resource use. Subsequent chart review showed that improvement on specific scale items confirmed the physician panel's opinion. Analysis of possible cost implications to society indicated that medication expenditures would be offset largely by delays in the need for paid home care and institutionalization, positive effects on caregiver health, and less time lost from work for the caregiver. From the perspective of a Canadian specialist panel, rivastigmine treatment for AD produces clinically relevant effects for patients that are beneficial to caregivers. These effects suggest decreased use of caregiver resources and delays in the need for institutionalization, both of which reduce societal costs.

Single and Multiple Clinical Syndromes in Incarcerated Offenders: Associations With Dissociative Experiences and Emotionality

PubMed Central

Garofalo, Carlo; Velotti, Patrizia; Crocamo, Cristina; Carrà, Giuseppe

2017-01-01

The present study examined the prevalence and correlates of clinical syndromes in a large group (N = 438) of incarcerated violent offenders, looking at differences between inmates with one and those with more than one clinical syndromes. More than a half of the sample (57%) reported clinically relevant symptoms for at least one clinical syndrome (n = 252), and the majority of them (38%) reported more syndromes in comorbidity (n = 169). Increased severity of clinical conditions (none, one, more than one syndrome) corresponded with significantly greater levels of personality disorder traits, psychological symptoms, dissociation, and negative emotionality, with large effect sizes. After controlling for co-occurrence of personality disorder traits and other symptoms, the presence of more than one comorbid syndrome significantly predicted unique variance in dissociation (positively) and positive emotionality (negatively). The presence of one clinical syndrome significantly and positively predicted negative emotionality. Findings support the possibility that the complexity, and not just the presence, of psychopathology could identify different groups of inmates. PMID:27913716

Single and Multiple Clinical Syndromes in Incarcerated Offenders: Associations With Dissociative Experiences and Emotionality.

PubMed

Garofalo, Carlo; Velotti, Patrizia; Crocamo, Cristina; Carrà, Giuseppe

2018-04-01

The present study examined the prevalence and correlates of clinical syndromes in a large group ( N = 438) of incarcerated violent offenders, looking at differences between inmates with one and those with more than one clinical syndromes. More than a half of the sample (57%) reported clinically relevant symptoms for at least one clinical syndrome ( n = 252), and the majority of them (38%) reported more syndromes in comorbidity ( n = 169). Increased severity of clinical conditions (none, one, more than one syndrome) corresponded with significantly greater levels of personality disorder traits, psychological symptoms, dissociation, and negative emotionality, with large effect sizes. After controlling for co-occurrence of personality disorder traits and other symptoms, the presence of more than one comorbid syndrome significantly predicted unique variance in dissociation (positively) and positive emotionality (negatively). The presence of one clinical syndrome significantly and positively predicted negative emotionality. Findings support the possibility that the complexity, and not just the presence, of psychopathology could identify different groups of inmates.

A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.

PubMed

Felicitas-Perkins, Jamie Q; Palalay, Melvin Paul; Cuaresma, Charlene; Ho, Reginald Cs; Chen, Moon S; Dang, Julie; Loui, William S

2017-07-01

We conducted an experimental pilot study in an oncology clinic in Honolulu, Hawai'i to determine the effect of a culturally-tailored educational DVD on cancer clinical trial participation among Filipino cancer patients. Thirty-seven patients participated in the study, with 17 randomized into the control group (ie, usual education) and 20 into the intervention group (ie, usual education plus educational DVD). Participants completed pre- and post-educational questionnaires with items asking about understanding of several cancer topics, behavioral outcomes, and attitudes regarding several treatment and physician related topics. A Fisher's exact test was conducted to explore the association between enrollment into a clinical trial and group assignment. General linear models were created to determine significant differences between study groups in post-education response scores for each questionnaire item after controlling for age, gender, education, and pre-education response scores. Two participants from the control group and three participants from the intervention group enrolled into clinical trials. Results showed no significant association between clinical trial enrollment and study group assignment ( P > .99). A significant difference was found between study groups on surety of joining the clinical trial suggested to them ( P = .013). A multilingual educational DVD to supplement clinical trial education may positively influence Filipino cancer patients to move forward with the decision to join a cancer clinical trial. However, health literacy may serve as a major barrier to actual enrollment into the particular clinical trial available to a patient.

Finishing effectiveness of different archwires using SmartClip™ self-ligating brackets: a clinical study.

PubMed

Ferrari, Simona; Bellincampi, Marta; Sfondrini, M Francesca; Caprioglio, Alberto; Gandini, Paola

2014-03-01

The aim of this clinical prospective trial was to evaluate finishing effectiveness of stainless steel (SS) archwires versus titanium molybdenum alloy (TMA) archwires using SmartClip™ self-ligating brackets. Thirty-two patients were divided in two groups: a group of 21 (G1-SS) and a group of 12 (G2-TMA). The protocol consisted of two different finishing archwires coupled with self-ligating brackets: .019 × .025" SS archwires for G1-SS and .019 × .025" TMA archwires for G2-TMA. Lateral cephalometric radiographs obtained at the beginning (T1) and end (T2) of treatment were used to assess the changes in incisor inclination, and measurements of irregularity index (LII), interdental widths, arch length (AL) and arch depth (AD) were made on dental casts to investigate changes associated with crowding correction. No significant differences from T1 to T2 were found for incisors proclination and AL changes. Statistically significant differences were found for LII (higher decrease in G1-SS), maxillary AD (higher increase in G1-SS) and three interdental maxillary widths (higher in G1-SS). The statistically significant differences found were few and clinically negligible. Self-ligating brackets system coupled with .019 × .025" archwires showed good finishing effectiveness, but no clinically significant differences were found between SS and TMA. Copyright © 2013 CEO. Published by Elsevier Masson SAS. All rights reserved.

Association between the clinical classification of hypothyroidism and reduced TSH in LT4 supplemental replacement treatment for pregnancy in China.

PubMed

Zhang, Lyu; Zhang, Zhaoyun; Ye, Hongying; Zhu, Xiaoming; Li, Yiming

2016-01-01

The study was aimed to evaluate the effects of levothyroxine (LT4) supplemental replacement treatment for pregnancy and analyze the associations between the clinical classification of hypothyroidism and reduced thyroid-stimulating hormone (TSH) in LT4 therapy. Totally, 195 pregnant women with hypothyroidism receiving routine prenatal care were enrolled. They were categorized into three groups: overt hypothyroidism (OH), subclinical hypothyroidism (SCH) with negative thyroperoxidase antibody (TPOAb), and SCH with positive TPOAb. The association between the clinical classification and reduced TSH in LT4 supplemental replacement treatment was assessed. The results indicated that reduced TSH was significantly different among the groups according to the clinical classifications (p = 0.043). The result was also significantly different between patients with OH and patients with SCH and negative TPOAb (p = 0.036). Similar result was reported for the comparison between patients with OH and patients with SCH and positive TPOAb (p = 0.016). Multiple variable analyses showed that LT4 supplementation, gestational age and the variable of clinical classifications were associated with reduced TSH independently. Our data suggested that the therapeutic effect of substitutive treatment with LT4 was significantly associated with different clinical classifications of hypothyroidism in pregnancy and the treatment should begin as soon as possible after diagnosis.

[Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections].

PubMed

Ma, Ling; Zhang, Yuan-Zhen; Zheng, Yi-Lin; Wang, Ze-Hua; Xu, You-di; Kong, Li-Na

2010-10-01

to evaluate clinical efficacy and safety of levornidazole in the treatment of pelvic anaerobic infections. a multicenter randomized controlled clinical study was conducted to evaluate clinical efficacy and safety of levornidazole. One hundred and fourty-three patients with pelvic anaerobic bacteria infection were classified into 70 cases treated by levornidazole in study group and 73 cases treated by Ornidazole in control group. Those patients in two groups were both administered at a dose of 0.5 g twice daily for 5 - 7 days. The rate of clinical efficacy, bacteria clearance and adverse effect were recorded and compared between two groups. at the endpoint, the rate of clinical efficacy were 80% (56/70) in study group and 81% (59/73) in control group, which did not reach significant difference (P > 0.05). The rate of bacteria clearance were 97% (36/37) in study group and 92% (22/24) in control group, which also did not reach significant difference (P > 0.05). The rate of adverse reaction of 3% (20/70) in study group was significantly lower than 22% (16/73) in control group (P < 0.05). it is effective and safe to treat pelvic anaerobic infections with levornidazole and sodium chloride injection.

Comparing performance of amoxicillin and intramuscular benzathine penicillin in relieving manifestations of streptococcal pharyngitis in children.

PubMed

Eslami, S T; Nassirian, A; Nassirian, H; Hatami, E; Sobhani, E; Najibpour, R

2014-12-01

To compare clinical and bacteriologic responses to intramuscular benzathine penicillin G (BPG) and single dose of amoxicillin in Group A streptococcal (GAS) pharyngitis. This study included 571 children from 6 to 15 years old age, with pharyngitis, who were admitted to 45 elementary and guidance schools from 7 regions of Education Organization in North-East of Iran, Mashhad. They were screened for enrollment and if he/she presented pharyngitis with clinical criteria of sore throat, erythema, exudate and tender or enlarged anterior cervical lymph nodes. Exclusion criteria included reports of antibiotic use, negative throat culture for GAS and history of allergy to the drugs. Clinical and bacteriologic responses to BPG and once daily orally amoxicillin were considered and compared. In the amoxicillin group, treatment failure was more than the penicillin group (18.9% vs. 6.4%, respectively) but the difference was not statistically significant (p < 0.05). Both drugs were significantly effective in reducing pharyngitis manifestations but penicillin was significantly more effective in reducing exudate than amoxicillin. Our study was in line with studies comparing the two drugs. The results show that once-daily therapy with amoxicillin is as effective as intramuscular benzathine penicillin G for the treatment of GAS pharyngitis, but penicillin was significantly more effective in reducing exudate and concurrent signs vs. amoxicillin.

Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

PubMed

Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

2011-11-01

Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

The effect of an automated clinical reminder on weight loss in primary care.

PubMed

O'Grady, Jason S; Thacher, Tom D; Chaudhry, Rajeev

2013-01-01

Overweight and obese individuals have increased health risks. Clinical reminders positively affect health outcomes in diabetes and osteoporosis, but the effect of automated prompts on weight loss in obesity has not been studied. Our objective was to determine whether an automatic prompt for the clinician to recommend lifestyle changes to patients with a body mass index (BMI) >25 kg/m(2) led to greater weight loss over a 3- to 6-month interval compared with the absence of a clinical reminder. We conducted a retrospective analysis of electronic medical records of obese adult patients with a BMI >25 kg/m(2) who were seen in 2009 and 2010, before and after implementation of an automated printed clinical reminder, respectively. We evaluated 1600 patients in each of the control and intervention groups. The primary outcome was the mean change in BMI between the control and intervention groups. Multiple linear regression was used to assess the effect of the clinical reminder on the change in BMI while adjusting for baseline BMI and potential confounding factors. The reduction in BMI (mean ± standard deviation) in the group with the clinical reminder (-0.084 ± 1.56 kg/m(2)) was not significantly greater than the control group (-0.053 ± 1.49 kg/m(2); P = .56). A regression model incorporating the clinical reminder, age, baseline BMI, obesity diagnosis, diabetes, and hyperlipidemia found that baseline BMI (P < .001), obesity diagnosis (P < .001), age (P = .001), and hyperlipidemia diagnosis (P = .02) were significant predictors of weight loss, but the clinical reminder was not (P = .78). There was a significant interaction between the clinical reminder and baseline BMI (P = .005), as the prompt increased weight loss more in those with lower baseline BMI. Automated clinical reminders alone do not improve weight loss in overweight and obese patients. Physician diagnoses of obesity or hyperlipidemia were associated with weight loss, suggesting that formally noting these diagnoses contributes to successful weight loss.

The effects of Clinical Pilates exercises on patients with shoulder pain: A randomised clinical trial.

PubMed

Atılgan, Esra; Aytar, Aydan; Çağlar, Aslıcan; Tığlı, Ayça Aytar; Arın, Gamze; Yapalı, Gökmen; Kısacık, Pınar; Berberoğlu, Utku; Şener, Hülya Özlem; Ünal, Edibe

2017-10-01

The purpose of this study was to determine the effect of Clinical Pilates exercises on patients with shoulder pain. Thirty-three patients, experiencing shoulder pain continuously for at least four weeks were selected as study subjects. The patients were randomly divided into two groups, namely Clinical Pilates exercise (n = 17) group and conventional exercise (n = 16) group. The patients were treated for five days a week, the total treatment being carried out for 10 days. The assessment of pain and disability amongst the patients were done at the baseline and at the end of the treatment sessions, using Visual Analogue Scale (VAS) and Shoulder Pain and Disability Index (SPADI). The clinical Pilates exercise group showed a significant improvement in all scores used for assessment (p < 0.05), while the conventional exercise group demonstrated a significant improvement only in the SPADI total score (p < 0.05). A comparison of scores for the VAS, SPADI-Pain and SPADI-Total between the two groups, revealed a significant improvement in the Clinical Pilates exercise group (p < 0.05). It was demonstrated by the study that Clinical Pilates exercise is an efficient technique for patients experiencing shoulder pain, as it helps reduce pain and disability among them. Copyright © 2017 Elsevier Ltd. All rights reserved.

Clinical evaluation of an innovative operative procedure in the treatment of the tethered cord syndrome.

PubMed

Hou, Yang; Sun, Jingchuan; Shi, Jiangang; Guo, Yongfei; Wang, Yuan; Shi, Guodong; Xu, Guohua

2018-06-01

The tethered cord syndrome (TCS) characterized by urination dysfunction has long been a worldwide clinical problem, of which clinical effects remains controversial. The objective of this study was to evaluate the clinical effects of an innovative surgical method for the treatment of TCS. This is a retrospective clinical study. There were 15 patients included in this study. The visual analog scale (VAS) and the Japanese Orthopaedic Association (JOA) scores were evaluated. The incidence of complications after surgery was also analyzed. A total of 15 patients including 9 men and 6 women with TCS underwent homogeneous spinal-shortening axial decompression (HSAD) from September 2011 to February 2015. The average age at the time of surgery was 38.1±17.7 years. The average postoperative follow-up period was 21.5±7.5 months. The VAS and JOA scores were used to evaluate the clinical effects of the new operational procedure. In addition, the incidence of complications was also recorded and analyzed. The VAS scores decreased from 3.93±2.52 to 1.80±1.21 at the final follow-up after surgery with a significant statistical difference (p=.006). The JOA scores also significantly increased from 9.93±3.43 to 21.20±4.18 at the final follow-up (p<.001). Fourteen cases (93.3%) with bladder dysfunction and 7 cases with sensory dysfunction of the lower limbs (87.5%) had a significant improvement postoperatively. Complications such as infection, pulmonary embolism, nerve injury, and broken rod were not observed during the follow-up period. The operation of HSAD was an effective and safe surgical method for TCS, which can achieve direct decompression of the tethered spinal cord. Copyright © 2017. Published by Elsevier Inc.

Comparison of the effect of endodontic-periodontal combined lesion on the outcome of endodontic microsurgery with that of isolated endodontic lesion: survival analysis using propensity score analysis.

PubMed

Song, Minju; Kang, Minji; Kang, Dae Ryong; Jung, Hoi In; Kim, Euiseong

2018-05-01

The purpose of this retrospective clinical study was to evaluate the effect of lesion types related to endodontic microsurgery on the clinical outcome. Patients who underwent endodontic microsurgery between March 2001 and March 2014 with a postoperative follow-up period of at least 1 year were included in the study. Survival analyses were conducted to compare the clinical outcomes between isolated endodontic lesion group (endo group) and endodontic-periodontal combined lesion group (endo-perio group) and to evaluate other clinical variables. To reduce the effect of selection bias in this study, the estimated propensity scores were used to match the cases of the endo group with those of the endo-perio group. Among the 414 eligible cases, the 83 cases in the endo-perio group were matched to 166 out of the 331 cases in the endo group based on propensity score matching (PSM). The cumulated success rates of the endo and endo-perio groups were 87.3 and 72.3%, respectively. The median success period of the endo-perio group was 12 years (95% CI: 5.507, 18.498). Lesion type was found to be significant according to both Log-rank test (P = 0.002) and Cox proportional hazard regression analysis (P = 0.001). Among the other clinical variables, sex (female or male), age, and tooth type (anterior, premolar, or molar) were determined to be significant in Cox regression analysis (P < 0.05). Endodontic-periodontal combined lesions had a negative effect on the clinical outcome based on an analysis that utilized PSM, a useful statistical matching method for observational studies. Lesion type is a significant predictor of the outcome of endodontic microsurgery.

The Effect of Cognitive Behavior Therapy in Insomnia due to Methadone Maintenance Therapy: A Randomized Clinical Trial

PubMed Central

Soleimani, Robabeh; Modabbernia, Mohammad Jafar; Habibi, Sharareh; Roudsary, Maryam Habibi; Elahi, Masoumeh

2015-01-01

Background: Sleep disturbance is a common complaint of patients undergoing methadone maintenance therapy (MMT). There are limited studies about the effect of different treatments on insomnia due to MMT. In this study, we evaluated the effect of cognitive-behavioral treatment for insomnia (CBTI) on sleep disorders in patients undergoing MMT. Methods: Twenty-two patients with insomnia due to MMT (aged 18-60 years) participated in this randomized double-blind clinical trial. The intervention group received CBTI from a clinical psychologist for 8 weeks, whereas the control group received behavioral placebo therapy (BPT). The duration of individual sessions was 45 minutes, which was conducted once a week. The primary outcome was sleep disturbance assessed with Pittsburgh Sleep Quality Index (PSQI). Data were analyzed using SPSS software version 19. Results: Eleven patients were assigned to each group. Two groups were matched according to demographic characteristics (age, marital status, education, and daily methadone doses). Although PSQI score was significantly reduced during weeks 5 and 8 after both interventions, there was a significant difference in intervention versus time interaction (P<0.02). The effects of CBTI versus placebo were significantly different (P<0.001). The time course was also significant (P<0.001). Conclusion: This study showed that CBTI is more effective than BPT in overall sleep quality. We recommend further studies, with a larger sample, on CBTI in patients undergoing MMT. PMID:26379345

Two-Implant-Supported Mandibular Overdentures: Do Clinical Denture Quality and Inter-Implant Distance Affect Patient Satisfaction?

PubMed

Alfadda, Sara A; Al Amri, Mohammad D; Al-Ohali, Amal; Al-Hakami, Arwa; Al-Madhi, Noura

To investigate the following three null hypotheses in patients rehabilitated with a mandibular overdenture supported by two unsplinted implants: (1) patient satisfaction is not related to the clinical quality of the dentures; (2) inter-implant distance (IID) has no effect on the clinical quality of the dentures; and (3) IID does not influence patient satisfaction. Forty edentulous patients who were rehabilitated with a two-implant-supported mandibular overdenture participated in the study. Independent investigators evaluated the dentures on the basis of five clinical criteria using the validated Denture Quality Evaluation Form, and the patients completed the validated Denture Satisfaction Scale. Irreversible hydrocolloid impressions of the mandible were made and poured immediately in die stone. The IID was measured by adapting an orthodontic wire to the mandibular alveolar ridge crest, extending from the center of one implant to the center of the other. Spearman correlation analyses were used to identify possible correlations, with a significance level set at P < .05. The clinicians' overall mean rating of the clinical quality of the dentures was 91.5% (standard deviation 6.27%). The stability of the mandibular overdenture and of the maxillary conventional complete denture was significantly related to satisfaction (r = 0.389 and r = 0.44, respectively). Significant associations were found between the mandibular stability items and satisfaction with both maxillary and mandibular dentures. The stability of the maxillary denture was significantly associated with patient satisfaction with mandibular denture retention, stability, and comfort. None of the 12 denture satisfaction items were significantly associated with IID. Similarly, IID did not have an effect on the quality of either denture in terms of retention, stability, or occlusion. Denture stability was the feature that had the most influence on patient satisfaction with the mandibular overdenture and with the maxillary conventional denture. IID had no effect on the clinical quality of either denture and did not influence patient satisfaction.

Brief strategic therapy for obsessive–compulsive disorder: a clinical and research protocol of a one-group observational study

PubMed Central

Pietrabissa, Giada; Manzoni, Gian Mauro; Gibson, Padraic; Boardman, Donald; Gori, Alessio; Castelnuovo, Gianluca

2016-01-01

Introduction Obsessive–compulsive disorder (OCD) is a disabling psychopathology. The mainstay of treatment includes cognitive–behavioural therapy (CBT) and medication management. However, individual suffering, functional impairments as well as the direct and indirect costs associated with the disease remain substantial. New treatment programmes are necessary and the brief strategic therapy (BST) has recently shown encouraging results in clinical practice but no quantitative study has as yet been conducted. Methods and analysis The clinical effectiveness of the OCD-specific BST protocol will be evaluated in a one-group observational study. Participants will be sequentially recruited from a state community psychotherapy clinic in Dublin, Ireland. Outcome measures will be the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Beck Depression Inventory-II (BDI-II). Data will be collected at baseline, at treatment termination and at 3 month follow-up. The statistical significance of the post-treatment effect will be assessed by the paired-sample Student t test, while clinical significance will be evaluated by means of the equivalence testing method, which will be also used to assess the maintenance of effect at follow-up. Ethics/dissemination The present study is approved by the Hesed House Ethics Board in Dublin. Findings will enhance the evidence-based knowledge about the clinical effectiveness of BST in treating OCD symptoms, prior to assessing its efficacy in a randomised and controlled clinical trial, and will be disseminated through publication in peer-reviewed journals and conference presentations. PMID:27013594

[Effects of Gushen Antai pills combined with progestin on serum β-HCG, P, E2 and CA125 in patients with threatened abortion].

PubMed

Tian, Chun-Man; Chen, Bo

2016-01-01

To investigate the clinical effect of Gushen Antai pills and progesterone in the treatment of threatened abortion, in order to provide references for early clinical intervention with threatened abortion. The 112 cases of patients with threatened abortion were randomly divided into the control group and the observation group. 56 cases in each group. Patients in the control group was injected with progesterone, the observation group was treated with Gushen Antai pills in addition to the therapy of the control group. Both groups were treated by drugs for two weeks. Their venous bloods (5 mL) were collected before treatment and in 1, 2 weeks after treatment to determine serum levels of β-HCG, P, E2 and CA125. The differences between the two groups after treatment were compared. The total effective rate of the control group and the observation group were 79% and 91.9% respectively, with a statistically significant difference between the two groups (P＜0.05). Two weeks after the treatment, the serum levels of P and E2 in the observation group were significantly higher than before treatment, but the serum CA125 levels decreased significantly after treatment (P<0.05). These indicators showed statistically significant difference compared with that of the control group (P<0.05). After treatment, the serum β-HCG levels of the two groups were significantly higher than before treatment (P<0.05), but there was no statistically significant difference between the two groups. Gushen Antai pills and progesterone had a better clinical curative effect in treatment threatened abortion, which could significantly raise serum β-HCG, P and E2, reduce serum CA125 and increase the tocolysis efficiency, and so it was worth promoted in clinic. Copyright© by the Chinese Pharmaceutical Association.

[Clinical effect of hemoperfusion combined with hemodialysis in treatment of severe organophosphate pesticide poisoning].

PubMed

Guo, Lei; Ye, Hua; Pan, Liwei; Sun, Laifang; Ying, Binyu

2014-12-01

To investigate the clinical effect of hemoperfusion combined with hemodialysis in the treatment of severe organophosphate pesticide poisoning. Ninety-eight patients with severe organophosphate pesticide poisoning who were admitted to the emergency department of our hospital from March 2005 to September 2013 were equally divided into control group and observation group according to treatment methods. The control group was given conventional emergency treatment, while the observation group was given hemoperfusion combined with hemodialysis and the conventional emergency treatment. The clinical outcomes and complications of two groups were compared. In the control group, 35 patients were cured and 14 patients died, so the cure rate was 71.4%. In the treatment group, 46 patients were cured and 3 patients died, so the cure rate was 93.9%. The treatment group had a significantly higher cure rate than the control group (χ² = 8.611, P < 0.05). And the treatment group had significantly shorter duration of coma (P < 0.01), mean length of hospital stay (P < 0.01), and time to recovery of cholinesterase activity (P < 0.01) and a significantly reduced dose of atropine than the control group (P < 0.01). The control group had significantly more cases of urinary retention than the treatment group (18 vs. 6, χ² = 4.991, P < 0.05). And the control group had more cases of intermediate syndrome, respiratory failure, delayed neurological damage, and rebound than the treatment group. Hemoperfusion combined hemodialysis has a good clinical effect and causes fewer complications in treating severe organophosphate pesticide poisoning, so it is worthy of clinical promotion.

Treatment of painful bone metastases in prostate and breast cancer patients with the therapeutic radiopharmaceutical rhenium-188-HEDP. Clinical benefit in a real-world study.

PubMed

Lange, Rogier; Overbeek, Floor; de Klerk, John M H; Pasker-de Jong, Pieternel C M; van den Berk, Alexandra M; Ter Heine, Rob; Rodenburg, Cees J; Kooistra, Anko; Hendrikse, N Harry; Bloemendal, Haiko J

2016-09-26

Rhenium-188-HEDP ((188)Re-HEDP) is an effective radiopharmaceutical for the palliative treatment of osteoblastic bone metastases. However, only limited data on its routine use are available and its effect on quality of life (QoL) has not been studied. Therefore, we evaluated the clinical benefit of (188)Re-HEDP in routine clinical care. Prostate or breast cancer patients with painful bone metastases receiving (188)Re-HEDP as a routine clinical procedure were eligible for evaluation. Clinical benefit was assessed in terms of efficacy and toxicity. Pain palliation and QoL were monitored using the visual analogue scale (VAS), corrected for opioid intake, and the EORTC QLQ-C30 Global health status/QoL-scale. Thrombocyte and leukocyte nadirs were used to assess haematological toxicity. 45 and 47 patients were evaluable for pain palliation and QoL, respectively. After a single injection of (188)Re-HEDP, the overall pain response rate was 69% and mean VAS-scores decreased relevantly and significantly (p < 0.05). Repeated treatment resulted in similar pain response. The overall QoL response rate was 68% and mean Global health status/QoL-scores increased relevantly and significantly. Haematological side effects were mild and transient. The clinically relevant response on pain and quality of life and the limited adverse events prove clinical benefit of treatment with (188)Re-HEDP and support its use in routine clinical care. Its effectiveness appears comparable to that of external beam radiotherapy.

Comparison of quality of life between two clinical conditions with immunosuppressive therapy: liver transplantation and multiple sclerosis.

PubMed

Fernández-Jiménez, E; Pérez-San-Gregorio, M A; Martín-Rodríguez, A; Domínguez-Cabello, E; Navarro-Mascarell, G; Bernardos-Rodríguez, A

2012-11-01

We aimed to compare quality of life in two clinical conditions treated with immunosuppressants: cadaveric liver transplant recipients and multiple sclerosis patients. We also assessed the clinical significance of these results regarding a representative age-adjusted sample of the general Spanish population. Using a cross-sectional design, the SF-36 Health Survey was used to evaluate 62 patients with these chronic conditions (31 in each group) who were matched for gender. An analysis of covariance was performed to control for the influence of time from multiple sclerosis diagnosis and liver transplantation surgery until assessment. Student t test of covariate-adjusted mean values was used as the statistical test and Cohen's d effect size index, to assess the magnitude of intergroup differences and assess clinical significance. Significantly worse scores were observed among the neurological patients compared with transplant recipients regarding role-physical (P = .038), general health (P = .003), vitality (P = .034), and physical functioning (P = .049), with medium effect sizes (Cohen's ds from -0.511 to -0.785). Against normative values, liver transplant recipients displayed relevant differences in all SF-36 subscales (Cohen's ds from -0.569 to -0.974) except for mental health (small effect size). Likewise, multiple sclerosis patients showed much greater differences versus the general population (Cohen's ds from -0.846 to -1.760). Liver transplant recipients showed better quality of life than multiple sclerosis patients (medium effect sizes) in physical quality-of-life dimensions. Interestingly, despite having controlled for time from diagnosis/transplantation, both medical conditions showed clinically significant impairments (large and medium effect sizes) in physical and psychosocial quality-of-life domains. We concluded that transplant recipients belong to a population that still requires special health care because, even after having undergone their treatment of choice, they do not achieve normal levels of biopsychosocial functioning. Copyright © 2012 Elsevier Inc. All rights reserved.

Effectiveness of Computer-Based Treatment for Dyslexia in a Clinical Care Setting: Outcomes and Moderators

ERIC Educational Resources Information Center

Tijms, Jurgen

2011-01-01

The clinical effectiveness of a treatment for children with dyslexia was examined, as well as the moderating impact of plausible cognitive and socio-economic factors on treatment success. Results revealed that the treatment group accrued significant greater gains than the control group in reading and spelling skills. The treatment group obtained a…

The Effect of an Extramural Program on the Perceived Clinical Competence of Dental Hygiene Students.

ERIC Educational Resources Information Center

Butters, Janice M.; Vaught, Randall L.

1999-01-01

A study investigated the effect of an extramural rotation on dental-hygiene students' self-perceptions of competence in specific clinical areas. Results indicate student perceptions of competence improved significantly on six of 19 dimensions of dental-hygiene practice over the course of the rotation, suggesting that rotation is a valuable…

Evaluation of the implementation of a clinical pharmacy service on an acute internal medicine ward in Italy.

PubMed

Lombardi, Nicola; Wei, Li; Ghaleb, Maisoon; Pasut, Enrico; Leschiutta, Silvia; Rossi, Paolo; Troncon, Maria Grazia

2018-04-10

Successful implementation of clinical pharmacy services is associated with improvement of appropriateness of prescribing. Both high clinical significance of pharmacist interventions and their high acceptance rate mean that potential harm to patients could be avoided. Evidence shows that low acceptance rate of pharmacist interventions can be associated with lack of communication between pharmacists and the rest of the healthcare team. The objective of this study was to evaluate the effect of a structured communication strategy on acceptance rate of interventions made by a clinical pharmacist implementing a ward-based clinical pharmacy service targeting elderly patients at high risk of drug-related problems. Characteristics of interventions made to improve appropriateness of prescribing, their clinical significance and intervention acceptance rate by doctors were recorded. A clinical pharmacy intervention study was conducted between September 2013 and December 2013 in an internal medicine ward of a teaching hospital. A trained clinical pharmacist provided pharmaceutical care to 94 patients aged over 70 years. The clinical pharmacist used the following communication and marketing tools to implement the service described: Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis; Specific, Measurable, Achievable, Realistic and Timely (SMART) goals; Awareness, Interest, Desire, Action (AIDA) model. A total of 740 interventions were made by the clinical pharmacist. The most common drug classes involved in interventions were: antibacterials for systemic use (11.1%) and anti-parkinson drugs (10.8%). The main drug-related problem categories triggering interventions were: no specific problem (15.9%) and prescription writing error (12.0%). A total of 93.2% of interventions were fully accepted by physicians. After assessment by an external panel 63.2% of interventions (96 interventions/ per month) were considered of moderate clinical significance and 23.4% (36 interventions/ per month) of major clinical significance. The most frequent interventions were to educate a healthcare professional (20.4%) and change dose (16.1%). To our knowledge this is the first study evaluating the effect of a structured communication strategy on acceptance rate of pharmacist interventions. Pharmaceutical care delivered by the clinical pharmacist is likely to have had beneficial outcomes. Clinical pharmacy services like the one described should be implemented widely to increase patient safety.

The Effect of Endothelin Receptor Antagonists in Patients with Eisenmenger Syndrome: A Systematic Review.

PubMed

Elshafay, Abdelrahman; Truong, Duy Hieu; AboElnas, Mohamed M; Idrees, Hossam; Metwali, Hatem G; Vuong, Nguyen Lam; Saad, Omar Ahmed; Hirayama, Kenji; Huy, Nguyen Tien

2018-04-01

The efficacy of endothelin receptor antagonists (ERAs) in the management of Eisenmenger syndrome (ES) remains controversial. The aim of this study is to systemically review the safety and effects of ERAs in improving the quality of life and basic cardiac functions of these patients. Twelve databases were searched, including PubMed, Web of Science, Scopus, Virtual Health Library, World Health Organization (WHO) Global Health Library, Google Scholar, POPLINE, Systems for Information of Grey Literature in Europe, New York Academy of Medicine, ClinicalTrials.gov, metaRegister of Controlled Trials and the WHO International Clinical Trials Registry Platform, through August 2016. We included randomized clinical trials addressing the effect of ERAs on cardiac functions in patients with ES. The quality of studies was assessed using the Cochrane Collaboration tool. We included two trials represented by four papers, of which three papers reported the efficacy of bosentan against placebo and one paper reported the results of a combination of bosentan and sildenafil versus placebo and bosentan. One trial showed a significant effect of bosentan treatment over placebo on indexed pulmonary vascular resistance and mean pulmonary artery pressure, but a non-significant increase in 6-min walk distance and a non-significant effect on systemic pulse oximetry. The other trial reported the safe but non-significant effect of combination therapy of bosentan and sildenafil compared with bosentan and placebo. This study demonstrated safety and improved hemodynamic effects of bosentan in ES, with a controversial effect on exercise capacity. Further randomized controlled trials with longer follow-up duration are needed to confirm these results.

Alzheimer's Therapeutics: Translation of Preclinical Science to Clinical Drug Development

PubMed Central

Savonenko, Alena V; Melnikova, Tatiana; Hiatt, Andrew; Li, Tong; Worley, Paul F; Troncoso, Juan C; Wong, Phil C; Price, Don L

2012-01-01

Over the past three decades, significant progress has been made in understanding the neurobiology of Alzheimer's disease. In recent years, the first attempts to implement novel mechanism-based treatments brought rather disappointing results, with low, if any, drug efficacy and significant side effects. A discrepancy between our expectations based on preclinical models and the results of clinical trials calls for a revision of our theoretical views and questions every stage of translation—from how we model the disease to how we run clinical trials. In the following sections, we will use some specific examples of the therapeutics from acetylcholinesterase inhibitors to recent anti-Aβ immunization and γ-secretase inhibition to discuss whether preclinical studies could predict the limitations in efficacy and side effects that we were so disappointed to observe in recent clinical trials. We discuss ways to improve both the predictive validity of mouse models and the translation of knowledge between preclinical and clinical stages of drug development. PMID:21937983

Assessment of Clinical Effect of Perioperative Comprehensive Nursing Intervention Pattern in 23G Minimally Invasive Vitreous Surgery.

PubMed

Shen, Jie; Li, Su-Yan; Wang, Jian-Yu; Chen, Jing; Wang, Wen

2016-01-01

We observed the clinical effects of comprehensive nursing intervention pattern in 23G minimally invasive vitreous surgery according to the comprehensive nursing intervention table developed by our hospital, which would supply a basis for its clinical application. In this prospective study, we followed 120 patients undergoing 23G minimally invasive vitreous surgery from Xuzhou First People's Hospital from February 2013 to February 2015 and divided them into control and observation groups by a random number table (60 patients in each group). A regular nursing pattern was adopted for the control group, and a comprehensive nursing intervention pattern was adopted for the observation group. After that, a comparative analysis was made to identify the differences between the clinical effects of the two groups. Scores of cognition ratio, patient compliance and comfort level of patients in the observation group were higher than those of the control group were, and there was significant difference between the groups (P< 0.05). Complication incidence of the observation group is significantly lower than that of the control group (P<0.05). The comprehensive nursing intervention pattern developed by our hospital can improve clinical effects notably, which is of application value .We recommend it to be applied in eye diseases.

Is computerised CBT really helpful for adult depression?-A meta-analytic re-evaluation of CCBT for adult depression in terms of clinical implementation and methodological validity.

PubMed

So, Mirai; Yamaguchi, Sosei; Hashimoto, Sora; Sado, Mitsuhiro; Furukawa, Toshi A; McCrone, Paul

2013-04-15

Depression is a major cause of disability worldwide, and computerised cognitive behavioural therapy (CCBT) is expected to be a more augmentative and efficient treatment. According to previous meta-analyses of CCBT, there is a need for a meta-analytic revaluation of the short-term effectiveness of this therapy and for an evaluation of its long-term effects, functional improvement and dropout. Five databases were used (MEDLINE, PsycINFO, EMBASE, CENTRAL and CiNii). We included all RCTs with proper concealment and blinding of outcome assessment for the clinical effectiveness of CCBT in adults (aged 18 and over) with depression. Using Cohen's method, the standard mean difference (SMD) for the overall pooled effects across the included studies was estimated with a random effect model. The main outcome measure and the relative risk of dropout were included in the meta-analysis. Fourteen trials met the inclusion criteria, and sixteen comparisons from these were used for the largest meta-analysis ever. All research used appropriate random sequence generation and Intention-to-Treat analyses (ITT), and employed self-reported measures as the primary outcome. For the sixteen comparisons (2807 participants) comparing CCBT and control conditions, the pooled SMD was -0.48 [95% IC -0.63 to -0.33], suggesting similar effect to the past reviews. Also, there was no significant clinical effect at long follow-up and no improvement of function found. Furthermore, a significantly higher drop-out rate was found for CCBT than for controls. When including studies without BDI as a rating scale and with only modern imputation as sensitivity analysis, the pooled SMD remained significant despite the reduction from a moderate to a small effect. Significant publication bias was found in a funnel plot and on two tests (Begg's p = 0.09; Egger's p = 0.01). Using a trim and fill analysis, the SMD was -0.32 [95% CI -0.49 to -0.16]. Despite a short-term reduction in depression at post-treatment, the effect at long follow-up and the function improvement were not significant, with significantly high drop-out. Considering the risk of bias, our meta-analysis implied that the clinical usefulness of current CCBT for adult depression may need to be re-considered downwards in terms of practical implementation and methodological validity.

Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis.

PubMed

Liu, Xiaoqian; Machado, Gustavo C; Eyles, Jillian P; Ravi, Varshini; Hunter, David J

2018-02-01

To investigate the efficacy and safety of dietary supplements for patients with osteoarthritis. An intervention systematic review with random effects meta-analysis and meta-regression. MEDLINE, EMBASE, Cochrane Register of Controlled Trials, Allied and Complementary Medicine and Cumulative Index to Nursing and Allied Health Literature were searched from inception to April 2017. Randomised controlled trials comparing oral supplements with placebo for hand, hip or knee osteoarthritis. Of 20 supplements investigated in 69 eligible studies, 7 (collagen hydrolysate, passion fruit peel extract, Curcuma longa extract, Boswellia serrata extract, curcumin, pycnogenol and L-carnitine) demonstrated large (effect size >0.80) and clinically important effects for pain reduction at short term. Another six (undenatured type II collagen, avocado soybean unsaponifiables, methylsulfonylmethane, diacerein, glucosamine and chondroitin) revealed statistically significant improvements on pain, but were of unclear clinical importance. Only green-lipped mussel extract and undenatured type II collagen had clinically important effects on pain at medium term. No supplements were identified with clinically important effects on pain reduction at long term. Similar results were found for physical function. Chondroitin demonstrated statistically significant, but not clinically important structural improvement (effect size -0.30, -0.42 to -0.17). There were no differences between supplements and placebo for safety outcomes, except for diacerein. The Grading of Recommendations Assessment, Development and Evaluation suggested a wide range of quality evidence from very low to high. The overall analysis including all trials showed that supplements provided moderate and clinically meaningful treatment effects on pain and function in patients with hand, hip or knee osteoarthritis at short term, although the quality of evidence was very low. Some supplements with a limited number of studies and participants suggested large treatment effects, while widely used supplements such as glucosamine and chondroitin were either ineffective or showed small and arguably clinically unimportant treatment effects. Supplements had no clinically important effects on pain and function at medium-term and long-term follow-ups. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Assessing adverse effects of intra-articular botulinum toxin A in healthy Beagle dogs: A placebo-controlled, blinded, randomized trial

PubMed Central

Jokinen, Tarja S.; Syrjä, Pernilla; Junnila, Jouni; Hielm-Björkman, Anna; Laitinen-Vapaavuori, Outi

2018-01-01

Objective To investigate the clinical, cytological, and histopathological adverse effects of intra-articularly injected botulinum toxin A in dogs and to study whether the toxin spreads from the joint after the injection. Methods A longitudinal, placebo-controlled, randomized clinical trial was conducted with six healthy laboratory Beagle dogs. Stifle joints were randomized to receive either 30 IU of onabotulinum toxin A or placebo in a 1:1 ratio. Adverse effects and spread of the toxin were examined by evaluating dynamic and static weight-bearing of the injected limbs, by assessing painless range of motion and pain on palpation of joints, and by performing synovial fluid analysis, neurological examination, and electrophysiological recordings at different examination time-points in a 12-week period after the injections. The dogs were then euthanized and autopsy and histopathological examination of joint structures and adjacent muscles and nerves were performed. Results Intra-articular botulinum toxin A did not cause local weakness or injection site pain. Instead, static weight-bearing and painless range of motion of stifle joints decreased in the placebo limbs. No clinically significant abnormalities associated with intra-articular botulinum toxin A were detected in the neurological examinations. Electrophysiological recordings showed low compound muscle action potentials in two dogs in the botulinum toxin A-injected limb. No significant changes were detected in the synovial fluid. Autopsy and histopathological examination of the joint and adjacent muscles and nerves did not reveal histopathological adverse effects of the toxin. Conclusion Intra-articular botulinum toxin A does not produce significant clinical, cytological, or histopathological adverse effects in healthy dogs. Based on the electrophysiological recordings, the toxin may spread from the joint, but its clinical impact seems to be low. PMID:29320549

Assessing adverse effects of intra-articular botulinum toxin A in healthy Beagle dogs: A placebo-controlled, blinded, randomized trial.

PubMed

Heikkilä, Helka M; Jokinen, Tarja S; Syrjä, Pernilla; Junnila, Jouni; Hielm-Björkman, Anna; Laitinen-Vapaavuori, Outi

2018-01-01

To investigate the clinical, cytological, and histopathological adverse effects of intra-articularly injected botulinum toxin A in dogs and to study whether the toxin spreads from the joint after the injection. A longitudinal, placebo-controlled, randomized clinical trial was conducted with six healthy laboratory Beagle dogs. Stifle joints were randomized to receive either 30 IU of onabotulinum toxin A or placebo in a 1:1 ratio. Adverse effects and spread of the toxin were examined by evaluating dynamic and static weight-bearing of the injected limbs, by assessing painless range of motion and pain on palpation of joints, and by performing synovial fluid analysis, neurological examination, and electrophysiological recordings at different examination time-points in a 12-week period after the injections. The dogs were then euthanized and autopsy and histopathological examination of joint structures and adjacent muscles and nerves were performed. Intra-articular botulinum toxin A did not cause local weakness or injection site pain. Instead, static weight-bearing and painless range of motion of stifle joints decreased in the placebo limbs. No clinically significant abnormalities associated with intra-articular botulinum toxin A were detected in the neurological examinations. Electrophysiological recordings showed low compound muscle action potentials in two dogs in the botulinum toxin A-injected limb. No significant changes were detected in the synovial fluid. Autopsy and histopathological examination of the joint and adjacent muscles and nerves did not reveal histopathological adverse effects of the toxin. Intra-articular botulinum toxin A does not produce significant clinical, cytological, or histopathological adverse effects in healthy dogs. Based on the electrophysiological recordings, the toxin may spread from the joint, but its clinical impact seems to be low.

The effects of resveratrol on markers of oxidative stress in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial.

PubMed

Seyyedebrahimi, ShadiSadat; Khodabandehloo, Hadi; Nasli Esfahani, Ensieh; Meshkani, Reza

2018-04-01

Oxidative stress plays a pivotal role in the pathogenesis of type 2 diabetes (T2D). In vitro and animal studies have shown that resveratrol exerts an antioxidant effect, but clinical trials addressing this effect in patients with T2D are limited. The aim of this study was to determine whether resveratrol supplementation affects oxidative stress markers in a randomized, placebo-controlled, double-blind clinical trial. A total of 48 patients with T2D randomly were assigned to receive 800 mg/day resveratrol or placebo for 2 months. Plasma total antioxidant capacity, malondialdehyde concentration, protein carbonyl and total thiol contents, intracellular superoxide anion (O 2 - ·) and hydrogen peroxide (H 2 O 2 ) in PBMCs, the expression of genes involved in oxidative stress responses (Nrf2, SOD, Cat, HO-1, RAGE, NOS) in PBMCs, and metabolic and anthropometric parameters were measured at the baseline and at the trial end. Compared with the placebo group, resveratrol reduced plasma protein carbonyl content and PBMCs O 2 - · level and significantly increased plasma total antioxidant capacity and total thiol content. Furthermore, the expression of Nrf2 and SOD was significantly increased after resveratrol consumption. Resveratrol had no significant effects on the metabolic and anthropometric parameters except for a significant reduction in weight, BMI, and blood pressure levels. Resveratrol was well tolerated, and no serious adverse event was occurred. Our study demonstrated that 8 weeks of supplementation with 800 mg/day resveratrol has an antioxidant effect in the blood and PBMCs of patients with T2D. Clinical Trial Registry number and website IRCT registration number: IRCT2015072523336N1 and http://en.search.irct.ir/view/24752 .

Clinic Design as Placebo—Using Design to Promote Healing and Support Treatments

PubMed Central

Schuster, Kai

2017-01-01

Analogously to the medical placebo effect, people seem to anticipate the quality of treatments based on external stimuli. In order to gain insights on the effect the built environment can have on a person’s judgments and behavior with a particular focus on health related issues, a quantitative survey (N = 851) with four groups before and after the renovation of a rehabilitation clinic has been conducted. In line with an overall modernization of the clinic, the entrance, the lobby, and some patient rooms have been changed. In the lobby, a service counter and coffee bar have been added as well as light colors and new flooring material to achieve a more modern and clean atmosphere in the sense of aesthetical appearance of the space. The outcome revealed that patients rate the intention to change their health behavior as well as the quality of food or significantly higher in a modernized clinic. These differences cannot be directly attributed solely to the changes in the building. Analogously to the medical placebo, an effect referred to as design placebo effect is, therefore, proposed to explain improved ratings of aspects that have not directly been changed due to the intervention. Other significant effects are attributable to winter and summer climate. During summer time, ratings for waiting area, atmosphere, patient rooms, as well as for staff were significantly higher. It is, therefore, assumed that aesthetic attributes, such as architectural design, or friendliness of the weather, exert their effects as perceptual placebos that directly influence judgment outcomes and behavioral intentions. Further research is needed to match certain design and general environmental features to their effects on patients and investigate their effect strength. PMID:29120378

Clinic Design as Placebo-Using Design to Promote Healing and Support Treatments.

PubMed

Rehn, Jonas; Schuster, Kai

2017-11-09

Analogously to the medical placebo effect, people seem to anticipate the quality of treatments based on external stimuli. In order to gain insights on the effect the built environment can have on a person's judgments and behavior with a particular focus on health related issues, a quantitative survey ( N = 851) with four groups before and after the renovation of a rehabilitation clinic has been conducted. In line with an overall modernization of the clinic, the entrance, the lobby, and some patient rooms have been changed. In the lobby, a service counter and coffee bar have been added as well as light colors and new flooring material to achieve a more modern and clean atmosphere in the sense of aesthetical appearance of the space. The outcome revealed that patients rate the intention to change their health behavior as well as the quality of food or significantly higher in a modernized clinic. These differences cannot be directly attributed solely to the changes in the building. Analogously to the medical placebo, an effect referred to as design placebo effect is, therefore, proposed to explain improved ratings of aspects that have not directly been changed due to the intervention. Other significant effects are attributable to winter and summer climate. During summer time, ratings for waiting area, atmosphere, patient rooms, as well as for staff were significantly higher. It is, therefore, assumed that aesthetic attributes, such as architectural design, or friendliness of the weather, exert their effects as perceptual placebos that directly influence judgment outcomes and behavioral intentions. Further research is needed to match certain design and general environmental features to their effects on patients and investigate their effect strength.

Pharmaco-electroencephalographic and clinical effects of the cholinergic substance--acetyl-L-carnitine--in patients with organic brain syndrome.

PubMed

Herrmann, W M; Dietrich, B; Hiersemenzel, R

1990-01-01

In two double-blind, placebo-controlled clinical studies of the nootropic compound acetyl-L-carnitine on the electroencephalogram (EEG) and impaired brain functions of elderly outpatients with mild to moderate cognitive decline of the organic brain syndrome, statistically significant effects could be detected after eight weeks (on the EEG), and after 12 weeks of treatment (on the physician's clinical global impression and the patient-rated level of activities of daily living). Side-effects of acetyl-L-carnitine were generally minor and overall rare. Longer treatment periods and further specifications with regard to the aetiopathology and degree of cognitive impairment are recommended for further clinical studies of this promising compound.

Acupuncture for Children with Autism Spectrum Disorders: A Systematic Review of Randomized Clinical Trials

ERIC Educational Resources Information Center

Lee, Myeong Soo; Choi, Tae-Young; Shin, Byung-Cheul; Ernst, Edzard

2012-01-01

This study aimed to assess the effectiveness of acupuncture as a treatment for autism spectrum disorders (ASD). We searched the literature using 15 databases. Eleven randomized clinical trials (RCTs) met our inclusion criteria. Most had significant methodological weaknesses. The studies' statistical and clinical heterogeneity prevented us from…

The effect of propolis honey candy on C. Albicans and clinical isolate biofilms viability (in-vitro)

NASA Astrophysics Data System (ADS)

Soekanto, Sri Angky; Bachtiar, Endang W.; Ramadhan, Amatul Firdaus; Febrina, Riri; Sahlan, Muhamad

2018-02-01

The objective of this study was to analyze the effectiveness of Propolis honey candy on the formation of C. Albicans ATCC 10231 and Clinical Isolate biofilms. C. Albicans ATCC 10231 and Clinical Isolate were cultured on 96-wellplates that were previously coated with saliva and serum on each well plate. On each group, a solution of Propolis honey candy, X candy, and honey candy was distributed with a 50% concentration of solution. The well plates were then tested using MTT assay. For the X Candy, both C. Albicans ATCC 10231 and Clinical Isolate biofilms that were coated with saliva and serum showed a significant increase of biofilm formation (0.669±0.320) compared to the control (0.223±0.138). However, there were no significant differences between Propolis honey candy (0.171±0.120) and honey candy (0.217±0.112) in the formation of C. Albicans ATCC 10231 and Clinical Isolate biofilms compared to control. Propolis honey candy has a tendency to decrease the formation of C. Albicans ATCC 10231 and Clinical Isolate biofilms.

Therapeutic role of rifampicin in Alzheimer's disease.

PubMed

Yulug, Burak; Hanoglu, Lütfü; Ozansoy, Mehmet; Isık, Dogan; Kilic, Ulkan; Kilic, Ertugrul; Schabitz, Wolf Rüdiger

2018-03-01

Rifampicin exerts significant brain protective functions in multiple experimental models. Here we summarize the underlying mechanisms of the neuroprotective and pro-cognitive effects of rifampicin that are mediated by its anti-inflammatory, anti-tau, anti-amyloid, and cholinergic effects. Beyond suggesting that rifampicin shows strong brain protective effects in preclinical models of Alzheimer's disease, we also provide substantial clinical evidence for the neuroprotective and pro-cognitive effects of rifampicin. Future neuroimaging studies combined with clinical assessment scores are the following steps to be taken in this field of research. © 2018 The Authors. Psychiatry and Clinical Neurosciences © 2018 Japanese Society of Psychiatry and Neurology.

Using Theater to Teach Clinical Empathy: A Pilot Study

PubMed Central

Leong, David; Anderson, Aaron; Wenzel, Richard P.

2007-01-01

Background Clinical empathy, a critical skill for the doctor–patient relationship, is infrequently taught in graduate medical education. No study has tested if clinical empathy can be taught effectively. Objective To assess whether medicine residents can learn clinical empathy techniques from theater professors. Design A controlled trial of a clinical empathy curriculum taught and assessed by 4 theater professors. Setting Virginia Commonwealth University, Richmond, Virginia, a large urban university and health system. Participants Twenty Internal Medicine residents: 14 in the intervention group, 6 in the control group. Intervention Six hours of classroom instruction and workshop time with professors of theater. Measurements Scores derived from an instrument with 6 subscores designed to measure empathy in real-time patient encounters. Baseline comparisons were made using two-sample T tests. A mixed-effects analysis of variance model was applied to test for significance between the control and intervention groups. Results The intervention group demonstrated significant improvement (p ≤ .011) across all 6 subscores between pre-intervention and post-intervention observations. Compared to the control group, the intervention group had better posttest scores in 5 of 6 subscores (p ≤ .01). Limitations The study was neither randomized nor blinded. Conclusions Collaborative efforts between the departments of theater and medicine are effective in teaching clinical empathy techniques. PMID:17486385

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.

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 predictive effect of insight on adverse clinical outcomes in bipolar I disorder: a two-year prospective study.

PubMed

Yen, Cheng-Fang; Chen, Cheng-Sheng; Yen, Ju-Yu; Ko, Chih-Hung

2008-05-01

Research has revealed that a lack of insight is associated with poorer clinical outcomes in schizophrenia; however, the predictive value of insight on adverse clinical outcomes among bipolar patients is quite understudied. The aim of this prospective study was to examine the impact of insight on adverse clinical outcomes among the patients with bipolar I disorder over a 2-year period. Sixty-five remitted bipolar I disorder patients received follow-up assessments at 3, 6, 9, 12, 18, and 24 months to detect the adverse clinical outcomes defined by the incidence of bipolar-related psychiatric hospitalization, emergency room visits, violent or suicidal behavior. The Schedule of Assessment of Insight was used to provide a baseline insight score. Cox regression analysis was used to examine the predictive value of insight on the adverse clinical outcomes. Impaired insight into treatment and a greater number of previous hospitalizations significantly increased the risk of adverse clinical outcomes with bipolar disorder in the 2-year period. However, insight into recognition of the illness and re-labeling of psychotic phenomena did not have any significant effect on adverse clinical outcomes. Bipolar patients' insight into treatment is an independent predictor of adverse clinical outcomes. Improving insight into treatment might be a promising target for a better outcome.

Effect of repeated simulated clinical use and sterilization on the cutting efficiency and flexibility of Hyflex CM nickel-titanium rotary files.

PubMed

Seago, Scott T; Bergeron, Brian E; Kirkpatrick, Timothy C; Roberts, Mark D; Roberts, Howard W; Himel, Van T; Sabey, Kent A

2015-05-01

Recent nickel-titanium manufacturing processes have resulted in an alloy that remains in a twinned martensitic phase at operating temperature. This alloy has been shown to have increased flexibility with added tolerance to cyclic and torsional fatigue. The aim of this study was to assess the effect of repeated simulated clinical use and sterilization on cutting efficiency and flexibility of Hyflex CM rotary files. Cutting efficiency was determined by measuring the load required to maintain a constant feed rate while instrumenting simulated canals. Flexibility was determined by using a 3-point bending test. Files were autoclaved after each use according to the manufacturer's recommendations. Files were tested through 10 simulated clinical uses. For cutting efficiency, mean data were analyzed by using multiple factor analysis of variance and the Dunnett post hoc test (P < .05). For flexibility, mean data were analyzed by using Levene's Test of Equality of Error and a general linear model (P < .05). No statistically significant decrease in cutting efficiency was noted in groups 2, 5, 6, and 7. A statistically significant decrease in cutting efficiency was noted in groups 3, 4, 8, 9, and 10. No statistically significant decrease in flexibility was noted in groups 2, 3, and 7. A statistically significant decrease in flexibility was noted in groups 4, 5, 6, 8, 9, 10, and 11. Repeated simulated clinical use and sterilization showed no effect on cutting efficiency through 1 use and no effect on flexibility through 2 uses. Published by Elsevier Inc.

The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals

PubMed Central

Shaw, Charles D.; Groene, Oliver; Botje, Daan; Sunol, Rosa; Kutryba, Basia; Klazinga, Niek; Bruneau, Charles; Hammer, Antje; Wang, Aolin; Arah, Onyebuchi A.; Wagner, Cordula; Klazinga, N; Kringos, DS; Lombarts, K; Plochg, T; Lopez, MA; Secanell, M; Sunol, R; Vallejo, P; Bartels, P; Kristensen, S; Michel, P; Saillour-Glenisson, F; Vlcek, F; Car, M; Jones, S; Klaus, E; Garel, P; Hanslik, K; Saluvan, M; Bruneau, C; Depaigne-Loth, A; Shaw, C; Hammer, A; Ommen, O; Pfaff, H; Groene, O; Botje, D; Wagner, C; Kutaj-Wasikowska, H; Kutryba, B; Escoval, A; Franca, M; Almeman, F; Kus, H; Ozturk, K; Mannion, R; Arah, OA; Chow, A; DerSarkissian, M; Thompson, C; Wang, A; Thompson, A

2014-01-01

Objective To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals. Design A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways. Setting and Participants Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Main Outcome Measure Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways. Results Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke). Conclusions Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes. PMID:24615598

The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals.

PubMed

Shaw, Charles D; Groene, Oliver; Botje, Daan; Sunol, Rosa; Kutryba, Basia; Klazinga, Niek; Bruneau, Charles; Hammer, Antje; Wang, Aolin; Arah, Onyebuchi A; Wagner, Cordula

2014-04-01

To investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals. A mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways. Seventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey. Four composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways. Accreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke). Accreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.

Reaching Urban Poor Hypertensive Patients: A Novel Model of Chronic Disease Care Versus a Traditional Fee-for-Service Approach.

PubMed

Sanders, Jim; Guse, Clare E

2016-08-09

There is a significant disparity in hypertensive treatment rates between those with and without health insurance. If left untreated, hypertension leads to significant morbidity and mortality. The uninsured face numerous barriers to access chronic disease care. We developed the Community-based Chronic Disease Management (CCDM) clinics specifically for the uninsured with hypertension utilizing nurse-led teams, community-based locations, and evidence-based clinical protocols. All services, including laboratory and medications, are provided on-site and free of charge. In order to ascertain if the CCDM model of care was as effective as traditional models of care in achieving blood pressure goals, we compared CCDM clinics' hypertensive care outcomes with 2 traditional fee-for-service physician-led clinics. All the clinics are located near one another in poor urban neighborhoods of Milwaukee, Wisconsin. Patients seen at the CCDM clinics and at 1 of the 2 traditional clinics showed a statistically significant improvement in reaching blood pressure goal at 6 months (P < .001 and P < .05, respectively). Logistic regression analysis found no difference in attaining blood pressure goal at 6 months for either of the 2 fee-for-service clinics when compared with the CCDM clinics. The CCDM model of care is at least as effective in controlling hypertension as more traditional fee-for-service models caring for the same population. The CCDM model of care to treat hypertension may offer another approach for engaging the urban poor in chronic disease care. © The Author(s) 2016.

Enhancing Placebo Effects: Insights From Social Psychology

PubMed Central

SLIWINSKI, JIM; ELKINS, GARY R.

2012-01-01

Placebo effects are widely recognized as having a potent impact upon treatment outcomes in both medical and psychological interventions, including hypnosis. In research utilizing randomized clinical trials, there is usually an effort to minimize or control placebo effects. However, in clinical practice there may be significant benefits in enhancing placebo effects. Prior research from the field of social psychology has identified three factors that may enhance placebo effects, namely: priming, client perceptions, and the theory of planned behavior. These factors are reviewed and illustrated via a case example. The consideration of social-psychological factors to enhance positive expectancies and beliefs has implications for clinical practice as well as future research into hypnotic interventions. PMID:23488251

Meta-analytic review of the effects of a single dose of intranasal oxytocin on threat processing in humans.

PubMed

Leppanen, Jenni; Ng, Kah Wee; Kim, Youl-Ri; Tchanturia, Kate; Treasure, Janet

2018-01-01

Heightened threat sensitivity is a transdiagnostic feature in several psychiatric disorders. The neuropeptide oxytocin has been shown to reduce fear related behaviours and facilitated fear extinction in animals. These findings have led to increasing interest to explore the effects of intranasal oxytocin on threat processing in humans. The review included 26 studies (N = 1173), nine of which included clinical populations (N = 234). The clinical groups included were people with borderline personality disorder (BPD), anorexia nervosa, bulimia nervosa, depression, anxiety, and alcohol dependence disorder. We examined the effects of a single dose of intranasal oxytocin on startle response, attentional responses, and behavioural responses to threat. A single dose of intranasal oxytocin significantly increased the physiological startle response to threat in healthy people with a small effect size. However, oxytocin did not have significant effects on attentional bias towards social or disorder-specific threat, fixation towards threatening stimuli among healthy or clinical populations, or on threat related behavioural approach or avoidance responses. No studies investigated the effects of oxytocin on the startle response to threat among clinical populations. Additionally, only one of the reviewed studies had sufficient power to detect at least a moderate effect of oxytocin according to our criterion. The synthesis of literature suggest that oxytocin may influence the salience of threatening stimuli among healthy individuals, increasing the startle response to threat. It would be of interest to investigate the effects of oxytocin on the startle response to threat among clinical populations. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of using mobile device-based academic electronic medical records for clinical practicum by undergraduate nursing students: A quasi-experimental study.

PubMed

Choi, Mona; Lee, HyeongSuk; Park, Joon Ho

2018-02-01

The academic electronic medical record (AEMR) system is applied with the expectation that nursing students will be able to attain competence in healthcare decision-making and nursing informatics competencies. However, there is insufficient evidence regarding the advantage of applying mobile devices to clinical practicum. This study aimed to examine the effect of an experiment that introduced a mobile AEMR application for undergraduate nursing students in their practicum. A quasi-experimental design was used. The subjects were 75 third-year nursing students enrolled in clinical practicum and were divided into an experimental (practicum with AEMR) and a control (conventional practicum) group. Nursing informatics competencies, critical thinking disposition, and satisfaction with clinical practicum were measured before and after the clinical practicum for each group. The usability of the AEMR application was also examined for the experimental group after the experiment. After the experiment, the experimental group showed a significant increase in the informatics knowledge domain of nursing informatics competencies in the post-test. The difference in critical thinking between the experimental and control groups was not statistically significant. Regarding satisfaction with the clinical practicum, the experimental group exhibited a significantly higher level of satisfaction in "preparation of a diagnostic test or laboratory test and understanding of the results" and "nursing intervention and documentation" than the control group. Students who participated in the practicum using the AEMR application considered it useful. The AEMR application was an effective educational method for practicing the immediate documentation of students' observations and interventions and was available at the patients' bedsides. To improve critical thinking, it is necessary to apply a variety of approaches when solving clinical problems. Copyright © 2017 Elsevier Ltd. All rights reserved.

The effect of Zataria multiflora extract on the clinical endometritis and reproductive indices in lactating Holstein dairy cows.

PubMed

Hajibemani, Abolfazl; Mirzaei, Abdolah; Rowshan Ghasrodashti, Abbas; Memarzadeh, Mohammad Reza

2016-01-01

In the present study, the effect of intrauterine infusion of Zataria multiflora extract on the clinical endometritis was investigated. Vaginal examination, transrectal palpation and ultrasonography were used to inspect the genital tract at 30-40 days in milk and two weeks later the same approach was applied. Cows with clinical endometritis were randomly divided into three treatment groups: Z. multiflora extract (n = 56), penicillin + streptomycin (pen + strep, n = 55), and placebo (n = 20). Cervical cytology, reagent strip test and cell counting by means of Neubauer hemocytometer were carried out in both examinations. Clinical cure rate of cows with endometritis of score 1 were 45.5, 34.5 and 53.6% in placebo, pen + strep and Z. multiflora , respectively. Clinical cure rate of cows with endometritis of score 2, 3 were 66.7, 84.6 and 56.0% in placebo, pen + strep and Z. multiflora , respectively. Overall, proportions of successfully treated cows were 55.0, 58.2 and 54.7% in placebo, pen + strep and Z. multiflora , respectively ( p > 0.05). In placebo, none of the parameters were significantly different between first and second examination, while we found the significant differences in percentage of neutrophils and leukocyte esterase activity in other groups ( p < 0.05). First service conception rate of cows was higher in Z. multiflora compared to other groups; however, this difference was not significant. In conclusion, pen + strep and Z. multiflora extract can be effective on the clinical endometritis and may improve reproductive performance. The extract of Z. multiflora can be useful as an alternative therapy for treatment of clinical endometritis in lactating dairy cows.

The effect of Zataria multiflora extract on the clinical endometritis and reproductive indices in lactating Holstein dairy cows

PubMed Central

Hajibemani, Abolfazl; Mirzaei, Abdolah; Rowshan Ghasrodashti, Abbas; Memarzadeh, Mohammad Reza

2016-01-01

In the present study, the effect of intrauterine infusion of Zataria multiflora extract on the clinical endometritis was investigated. Vaginal examination, transrectal palpation and ultrasonography were used to inspect the genital tract at 30-40 days in milk and two weeks later the same approach was applied. Cows with clinical endometritis were randomly divided into three treatment groups: Z. multiflora extract (n = 56), penicillin + streptomycin (pen + strep, n = 55), and placebo (n = 20). Cervical cytology, reagent strip test and cell counting by means of Neubauer hemocytometer were carried out in both examinations. Clinical cure rate of cows with endometritis of score 1 were 45.5, 34.5 and 53.6% in placebo, pen + strep and Z. multiflora, respectively. Clinical cure rate of cows with endometritis of score 2, 3 were 66.7, 84.6 and 56.0% in placebo, pen + strep and Z. multiflora, respectively. Overall, proportions of successfully treated cows were 55.0, 58.2 and 54.7% in placebo, pen + strep and Z. multiflora, respectively (p > 0.05). In placebo, none of the parameters were significantly different between first and second examination, while we found the significant differences in percentage of neutrophils and leukocyte esterase activity in other groups (p < 0.05). First service conception rate of cows was higher in Z. multiflora compared to other groups; however, this difference was not significant. In conclusion, pen + strep and Z. multiflora extract can be effective on the clinical endometritis and may improve reproductive performance. The extract of Z. multiflora can be useful as an alternative therapy for treatment of clinical endometritis in lactating dairy cows. PMID:28144422

Clinical and microbiological effects of levofloxacin in the treatment of chronic periodontitis: a randomized, placebo-controlled clinical trial.

PubMed

Pradeep, Avani R; Singh, Sonender P; Martande, Santosh S; Naik, Savitha B; N, Priyanka; Kalra, Nitish; Suke, Deepak K

2015-08-01

The aim of the present study was to evaluate the clinical and microbiological effect of systemic levofloxacin (LFX) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis (CP). Sixty-five patients with CP were randomly divided into a test (n = 33, SRP and LFX 500 mg, once daily [o.d.]) and a control group (n = 32, SRP and placebo, o.d.). Plaque index (PI), gingival index (GI), percentage of sites with bleeding on probing (%BoP), probing depth (PD), and clinical attachment level (CAL) were recorded at baseline, 10 days, and 1-, 3-, and 6-month intervals. The percentage of sites positive for Aggregatibacter actinomycetemcomitans (A. actinomycetemcomitans), Porphyromonas gingivalis, and Tannerella forsythia were recorded at baseline and at 3 and 6 months. Patients receiving LFX showed statistically-significant improvements in mean PD and CAL. The intergroup difference in PI, GI, and%BoP was not significant at any interval. There was a reduction in the percentage of sites positive for periodontopathic bacteria over the duration of the study in both groups, and a statistically-significant reduction in the number of sites positive for A. actinomycetemcomitans in the LFX group (P < 0.001). Levofloxacin was found to significantly improve the clinical and microbiological parameters in CP individuals. © 2014 Wiley Publishing Asia Pty Ltd.

[Quantitative Prediction of Drug-Drug Interaction Caused by CYP Inhibition and Induction from In Vivo Data and Its Application in Daily Clinical Practices-Proposal for the Pharmacokinetic Interaction Significance Classification System (PISCS)].

PubMed

Ohno, Yoshiyuki

2018-01-01

　Drug-drug interactions (DDIs) can affect the clearance of various drugs from the body; however, these effects are difficult to sufficiently evaluate in clinical studies. This article outlines our approach to improving methods for evaluating and providing drug information relative to the effects of DDIs. In a previous study, total exposure changes to many substrate drugs of CYP caused by the co-administration of inhibitor or inducer drugs were successfully predicted using in vivo data. There are two parameters for the prediction: the contribution ratio of the enzyme to oral clearance for substrates (CR), and either the inhibition ratio for inhibitors (IR) or the increase in clearance of substrates produced by induction (IC). To apply these predictions in daily pharmacotherapy, the clinical significance of any pharmacokinetic changes must be carefully evaluated. We constructed a pharmacokinetic interaction significance classification system (PISCS) in which the clinical significance of DDIs was considered in a systematic manner, according to pharmacokinetic changes. The PISCS suggests that many current 'alert' classifications are potentially inappropriate, especially for drug combinations in which pharmacokinetics have not yet been evaluated. It is expected that PISCS would contribute to constructing a reliable system to alert pharmacists, physicians and consumers of a broad range of pharmacokinetic DDIs in order to more safely manage daily clinical practices.

Electronic Immunization Alerts and Spillover Effects on Other Preventive Care.

PubMed

Kim, Julia M; Rivera, Maria; Persing, Nichole; Bundy, David G; Psoter, Kevin J; Ghazarian, Sharon R; Miller, Marlene R; Solomon, Barry S

2017-08-01

The impact of electronic health record (EHR) immunization clinical alert systems on the delivery of other preventive services remains unknown. We assessed for spillover effects of an EHR immunization alert on delivery of 6 other preventive services, in children 18 to 30 months of age needing immunizations. We conducted a secondary data analysis, with additional primary data collection, of a randomized, historically controlled trial to improve immunization rates with EHR alerts, in an urban, primary care clinic. No significant differences were found in screening for anemia, lead, development, nutrition, and injury prevention counseling in children prompting EHR immunization alerts (n = 129), compared with controls (n = 135). Significant increases in oral health screening in patients prompting EHR alerts (odds ratio = 4.8, 95% CI = 1.8-13.0) were likely due to practice changes over time. An EHR clinical alert system targeting immunizations did not have a spillover effect on the delivery of other preventive services.

Antimicrobial effects of a new therapeutic liquid dentifrice formulation on oral bacteria including odorigenic species.

PubMed

Sreenivasan, P K; Furgang, D; Zhang, Y; DeVizio, W; Fine, D H

2005-03-01

The control of oral malodor is well-recognized in efforts to improve oral health. Antimicrobial formulations can mitigate oral malodor, however, procedures to assess effects on oral bacteria including those implicated in halitosis are unavailable. This investigation examined the antimicrobial effects of a new liquid triclosan/copolymer dentifrice (test) formulation that demonstrated significant inhibition of oral malodor in previous organoleptic clinical studies. Procedures compared antimicrobial effects of the test and control formulations on a range of oral micro-organisms including members implicated in halitosis, substantive antimicrobial effects of formulations with hydroxyapatite as a surrogate for human teeth and ex vivo effects on oral bacteria from human volunteers. With Actinomyces viscosus, as a model system, the test formulation demonstrated a dose-dependent effect. At these concentrations the test formulation provided significant antimicrobial effects on 13 strains of oral bacteria including those implicated in bad breath at selected posttreatment time points. Treatment of hydroxyapatite by the test dentifrice resulted in a significant and substantive antimicrobial effect vs. controls. Oral bacteria from subjects treated ex vivo with the test dentifrice resulted in significant reductions in cultivable oral bacteria and odorigenic bacteria producing hydrogen sulfide. In summary, microbiological methods adapted to study odorigenic bacteria demonstrate the significant antimicrobial effects of the test (triclosan/copolymer) dentifrice with laboratory and clinical strains of oral bacteria implicated in bad breath.

Quantitative evaluation of the clinical efficacy of attention bias modification treatment for anxiety disorders.

PubMed

Linetzky, Marian; Pergamin-Hight, Lee; Pine, Daniel S; Bar-Haim, Yair

2015-06-01

Attention bias modification treatment (ABMT) is a novel treatment for anxiety disorders. Although a number of other meta-analytic reviews exist, the purpose of the present meta-analysis is to examine issues unaddressed in prior reviews. Specifically, the review estimates the efficacy of ABMT in clinically anxious patients and examines the effect of delivery context (clinic vs. home) on symptom reduction. A literature search using PsychInfo and Web of Science databases was performed. Only randomized controlled trials (RCTs) examining dot-probe-based ABMT in clinically diagnosed anxious patients were included. From 714 articles located through the search, 36 ABMT studies were identified and 11 studies met inclusion criteria (N = 589 patients). ABMT was associated with greater clinician-rated reductions in anxiety symptoms relative to control training: between-groups effect (d = 0.42, P = .001, confidence interval (CI) = 0.18-0.66), contrast of within-group effects (Q = 7.25, P < .01). More patients in the treatment group no longer met formal diagnostic criteria for their anxiety disorder posttreatment relative to patients in the control condition (P < .05). Analyses of patients' self-reported anxiety were nonsignificant for the between-groups contrast (P = .35), and were at a trend level of significance for the contrast between the within-group effects (P = .06). Moderation analysis of the between-groups effect revealed a significant effect for ABMT delivered in the clinic (d = 0.34, P = 0.01, CI = 0.07-0.62), and a nonsignificant effect for ABMT delivered at home (d = -0.10, P = 0.40, CI = -0.33-0.13). The current meta-analysis provides support for ABMT as a novel evidenced-based treatment for anxiety disorders. Overall, ABMT effects are mainly evident when it is delivered in the clinic and when clinical outcome is evaluated by a clinician. More RCTs of ABMT in specific anxiety disorders are warranted. © 2015 Wiley Periodicals, Inc.

[Observation on clinical therapeutic effect of improved thunder-fire miraculous needle on vertigo].

PubMed

Zhang, Gong-an; Luo, Jian; Huang, Liu-he

2008-04-01

To Compare clinical therapeutic effect of improved thunder-fire miraculous needle and moxibustion on vertigo. One hundred and seventeen cases conformed with the TCM criteria of vertigo were randomly divided into an observation group (n=66) and a control group (n=51). The observation group were treated with improved thunder-fire miraculous needle and the control group with pressing and moxibustion at Baihui (GV 20). After treatment of one therapeutic course, the therapeutic effect was assessed by vertigo symptom rating scores. The total effective rate was 86.4% in the observation group and 66.7% in the control group, with a significant difference between the two groups (P<0.05). The improved thunder-fire miraculous needle can significantly relieve and eliminate symptoms of vertigo, with no adverse effect.

The Effect of Cognitive-Behavioral Therapy versus Treatment as Usual for Anxiety in Children with Autism Spectrum Disorders: A Randomized, Controlled Trial

ERIC Educational Resources Information Center

Storch, Eric A.; Arnold, Elysse B.; Lewin, Adam B.; Nadeau, Josh M.; Jones, Anna M.; De Nadai, Alessandro S.; Mutch, P. Jane; Selles, Robert R.; Ung, Danielle; Murphy, Tanya K.

2013-01-01

Objective: To examine the efficacy of a modular cognitive-behavioral therapy (CBT) protocol relative to treatment as usual (TAU) among children with high-functioning autism spectrum disorders (ASD) and clinically significant anxiety. Method: A total of 45 children (7-11 years of age) with high-functioning ASD and clinically significant anxiety…

The experience of clinical supervision for nurses and healthcare assistants in a secure adolescent service: Affecting service improvement.

PubMed

McCarron, R H; Eade, J; Delmage, E

2018-04-01

WHAT IS KNOWN ON THE SUBJECT?: Regular and effective clinical supervision for mental health nurses and healthcare assistants (HCAs) is an important tool in helping to reduce stress and burnout, and in ensuring safe, effective and high-quality mental health care. Previous studies of clinical supervision within secure mental health environments have found both a low availability of clinical supervision, and a low level of staff acceptance of its value, particularly for HCAs. WHAT DOES THIS PAPER ADD TO EXISTING KNOWLEDGE?: In previous studies, the understanding shown by HCAs and nurses around the benefits of clinical supervision may have been limited by the methods used. This study was specifically designed to help them best express their views. In contrast to previous studies, both nurses and HCAs showed a good understanding of the function and value of clinical supervision. Significant improvements in the experience of, and access to, clinical supervision for nurses and HCAs working in secure mental health services may be achieved by raising staff awareness, demonstrating organizational support and increasing monitoring of clinical supervision. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Organizations should consider reviewing their approach to supervision to include raising staff awareness, multidisciplinary supervision, group supervision, and recording and tracking of supervision rates. Organizations should be mindful of the need to provide effective clinical supervision to HCAs as well as nurses. Introduction Studies have found a low availability and appreciation of clinical supervision, especially for healthcare assistants (HCAs). Qualitative research is needed to further understand this. Aims Increase understanding of nurses' and HCAs' experiences of, and access to, clinical supervision. Identify nurses' and HCAs' perceptions of the value and function of clinical supervision. Assess how interventions affect staff's experiences of clinical supervision. Methods In 2013, HCAs and nurses in a secure adolescent service were surveyed about clinical supervision. Forty-nine HCAs and 20 nurses responded. In 2014, interventions to facilitate supervision were introduced. In 2016, the study was repeated. Forty HCAs and 30 nurses responded. Responses were analysed using a mixed methods approach. Results Significantly more HCAs found supervision to be a positive experience in 2016, and both nurses and HCAs reported significantly fewer challenges in accessing supervision. HCAs and nurses understood the value of clinical supervision. Discussion Significant improvements in the experience of clinical supervision were achieved following increased staff awareness, multidisciplinary and group supervision, and recording supervision rates. HCAs and nurses understood the consequences of inadequate supervision. Implications for practice Organizations could adopt the interventions to facilitate clinical supervision. Supervision should not be overlooked for HCAs. © 2017 John Wiley & Sons Ltd.

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.

Effectiveness of Internet-based cognitive-behavior therapy for social anxiety disorder in clinical psychiatry.

PubMed

El Alaoui, Samir; Hedman, Erik; Kaldo, Viktor; Hesser, Hugo; Kraepelien, Martin; Andersson, Evelyn; Rück, Christian; Andersson, Gerhard; Ljótsson, Brjánn; Lindefors, Nils

2015-10-01

Internet-based cognitive-behavioral therapy (ICBT) has received increased attention as an innovative approach to improve access to evidence-based psychological treatments. Although the efficacy of ICBT for social anxiety disorder has been established in several studies, there is limited knowledge of its effectiveness and application in clinical psychiatric care. The purpose of this study was to evaluate the effectiveness of ICBT in the treatment of social anxiety disorder and to determine the significance of patient adherence and the clinic's years of experience in delivering ICBT. A longitudinal cohort study was conducted using latent growth curve modeling of patients (N = 654) treated with ICBT at an outpatient psychiatric clinic between 2009 and 2013. The primary outcome measure was the Liebowitz Social Anxiety Scale-Self-Rated. Significant reductions in symptoms of social anxiety were observed after treatment (effect size d = 0.86, 99% CI [0.74, 0.98]). Improvements were sustained at 6-month follow-up (d = 1.15, 99% CI [0.99, 1.32]). Patient adherence had a positive effect on the rate of improvement. A positive association between the clinic's years of experience with ICBT and treatment outcome was also observed. This study suggests that ICBT for social anxiety disorder is effective when delivered within the context of a unit specialized in Internet-based psychiatric care and may be considered as a treatment alternative for implementation within the mental health care system. (c) 2015 APA, all rights reserved).

Effects of Team-Based Learning on the Core Competencies of Nursing Students: A Quasi-Experimental Study.

PubMed

Lee, Kyung Eun

2018-04-01

An important goal of nursing education is helping students achieve core competencies efficiently. One proposed way of improving nursing education is team-based learning (TBL). The aim of this study was to assess the comparative effectiveness of TBL and lecture-style classes in terms of teaching core competencies in nursing education, which include clinical competence skills, problem-solving ability, communication competencies, critical thinking ability, and self-leadership. This quasi-experimental study enrolled 183 students as participants, with 95 and 88 in the experimental and control groups, respectively. These two groups attended 6 hours (2 hours weekly for 3 weeks) of TBL and lecture-style classes, respectively. Differences in core competencies between the two groups were compared before and after the intervention. The experimental group achieved significantly higher scores for clinical competence skills, communication competence, critical thinking ability, and self-leadership at posttest than at pretest, whereas the control group achieved significantly higher scores for clinical competence skills and critical thinking ability at posttest than at pretest. After the intervention, the experimental group had significantly better clinical competence skills, communication competence, and self-leadership than the control group. TBL is an effective approach method to teaching core competencies in nursing education.

The effect of N-acetyl-l-cysteine (NAC) on liver toxicity and clinical outcome after hematopoietic stem cell transplantation.

PubMed

El-Serafi, Ibrahim; Remberger, Mats; El-Serafi, Ahmed; Benkessou, Fadwa; Zheng, Wenyi; Martell, Eva; Ljungman, Per; Mattsson, Jonas; Hassan, Moustapha

2018-05-29

Busulphan (Bu) is a myeloablative drug used for conditioning prior to hematopoietic stem cell transplantation. Bu is predominantly metabolized through glutathione conjugation, a reaction that consumes the hepatic glutathione. N-acetyl-l-cysteine (NAC) is a glutathione precursor used in the treatment of acetaminophen hepatotoxicity. NAC does not interfere with the busulphan myeloablative effect. We investigated the effect of NAC concomitant treatment during busulphan conditioning on the liver enzymes as well as the clinical outcome. Prophylactic NAC treatment was given to 54 patients upon the start of busulphan conditioning. These patients were compared with 54 historical matched controls who did not receive NAC treatment. In patients treated with NAC, aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) were significantly (P < 0.05) decreased after conditioning compared to their start values. Within the NAC-group, liver enzymes were normalized in those patients (30%) who had significantly high start values. No significant decrease in enzyme levels was observed in the control group. Furthermore, NAC affected neither Bu kinetics nor clinical outcome (sinusoidal obstruction syndrome incidence, graft-versus-host disease and/or graft failure). NAC is a potential prophylactic treatment for hepatotoxicity during busulphan conditioning. NAC therapy did not alter busulphan kinetics or affect clinical outcome.

Effect of surgical periodontal treatment associated to antimicrobial photodynamic therapy on chronic periodontitis: A randomized controlled clinical trial.

PubMed

Martins, Sérgio H L; Novaes, Arthur B; Taba, Mario; Palioto, Daniela B; Messora, Michel R; Reino, Danilo M; Souza, Sérgio L S

2017-07-01

This randomized controlled clinical trial evaluated the effects of an adjunctive single application of antimicrobial photodynamic therapy (aPDT) in Surgical Periodontal Treatment (ST) in patients with severe chronic periodontitis (SCP). In a split-mouth design, 20 patients with SCP were treated with aPDT+ST (Test Group, TG) or ST only (Control Group, CG). aPDT was applied in a single episode, using a diode laser and a phenothiazine photosensitizer. All patients were monitored until 90 days after surgical therapy. Levels of 40 subgingival species were measured by checkerboard DNA-DNA hybridization at baseline, 60 and 150 days. Clinical and microbiological parameters were evaluated. In deep periodontal pockets depth (PPD ≥5 mm), Test Group presented a significantly higher decrease in PPD than Control Group at 90 days after surgical therapy (p < .05). Test Group also demonstrated significantly less periodontal pathogens of red complex (Treponema denticola) (p < .05). A single episode of aPDT used in adjunct to open flap debridement of the root surface in the surgical treatment of SCP: i) significantly improved clinical periodontal parameters; ii) eliminates periodontal pathogens of the red complex more effectively (NCT02734784). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effects of hyperimmune equine plasma on clinical and cellular responses in a low-dose endotoxaemia model in horses.

PubMed

Forbes, G; Church, S; Savage, C J; Bailey, S R

2012-02-01

Endotoxaemia is a major cause of equine morbidity, and plasma from horses immunised against Escherichia coli is used in its treatment. The aim of this study was to determine the effects of hyperimmune plasma on the clinical and leukocyte responses, including production and activity of TNFα, in an in vivo endotoxin challenge model. Pre-treatment with hyperimmune equine plasma had no significant effect on peak total plasma TNFα concentration (occurring 90min after the administration of 30ng/kg LPS). However, the bioavailable (unbound) TNFα measured by bioassay was significantly reduced in plasma-treated horses (1044.44±193.93pg/ml at 90min) compared to saline treated controls (1373.92±107.63pg/ml; P=0.05). Therefore, although pre-treatment with hyperimmune equine plasma did not significantly modify the clinical signs of endotoxaemia in this model, there was some evidence of reduced TNF bioactivity, which may be due to factors in the plasma which bind and reduce the activity of this cytokine. Copyright © 2010 Elsevier Ltd. All rights reserved.

ANTIPLAQUE AND ANTIGINGIVITIS EFFECT OF LIPPIA SIDOIDES. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

PubMed Central

Rodrigues, Ítalo Sarto Carvalho; Tavares, Vinícius Nascimento; Pereira, Sérgio Luís da Silva; da Costa, Flávio Nogueira

2009-01-01

Objectives: The antiplaque and antigingivitis effect of Lippia Sidoides (LS) was evaluated in this in vivo investigation. Material and Methods: Twenty-three subjects participated in a cross-over, double-blind clinical study, using 21-day partial-mouth experimental model of gingivitis. A toothshield was constructed for each volunteer, avoiding the brushing of the 4 experimental posterior teeth in the lower left quadrant. The subjects were randomly assigned initially to use either the placebo gel (control group) or the test gel, containing 10% LS (test group). Results: The clinical results showed statistically significant differences for plaque index (PLI) (p<0.01) between days 0 and 21 in both groups, however only the control group showed statistically significant difference (p<0.01) for the bleeding (IB) and gingival (GI) index within the experimental period of 21 days. On day 21, the test group presented significantly better results than the control group with regard to the GI (p<0.05). Conclusions: The test gel containing 10% LS was effective in the control of gingivitis. PMID:19936516

Parent Depression and Anger in Peer-Delivered Parent Support Services

PubMed Central

Shen, Sa; Rodriguez, James; Radigan, Marleen; Burton, Geraldine; Hoagwood, Kimberly E.

2017-01-01

Knowledge about parents who seek peer-delivered parent support services in children’s mental health is limited. In this prospective study, characteristics of 124 parents who sought peer parent advocate services related to their children’s behavioral difficulties are described. This urban sample consisted primarily of low-income mothers of color, 80% of whom were caring for children with clinically significant behavioral problems. Of these parents, 64% endorsed clinically significant levels of depressive symptoms at baseline. Linear mixed effects models were used to examine associations between parent depression and anger expression with working alliances with peer advocates. No independent or combined effects of parent depression or anger expression on working alliance were found. However, adjusting for family demographic factors, caregiver strain and child symptoms, parent depression interacted with anger expression to influence working alliances, primarily around agreement and mutual engagement on goals. Among parents who endorsed clinically significant depressive symptoms, anger expression did not influence working alliance but among non-depressed parents, anger expression was negatively associated with working alliance. Implications for training peer parent advocates to more effectively engage low income parents are discussed. PMID:28775660

Parent Depression and Anger in Peer-Delivered Parent Support Services.

PubMed

Olin, S Serene; Shen, Sa; Rodriguez, James; Radigan, Marleen; Burton, Geraldine; Hoagwood, Kimberly E

2015-11-01

Knowledge about parents who seek peer-delivered parent support services in children's mental health is limited. In this prospective study, characteristics of 124 parents who sought peer parent advocate services related to their children's behavioral difficulties are described. This urban sample consisted primarily of low-income mothers of color, 80% of whom were caring for children with clinically significant behavioral problems. Of these parents, 64% endorsed clinically significant levels of depressive symptoms at baseline. Linear mixed effects models were used to examine associations between parent depression and anger expression with working alliances with peer advocates. No independent or combined effects of parent depression or anger expression on working alliance were found. However, adjusting for family demographic factors, caregiver strain and child symptoms, parent depression interacted with anger expression to influence working alliances, primarily around agreement and mutual engagement on goals. Among parents who endorsed clinically significant depressive symptoms, anger expression did not influence working alliance but among non-depressed parents, anger expression was negatively associated with working alliance. Implications for training peer parent advocates to more effectively engage low income parents are discussed.

[Respiratory hypercapnic-hypoxic training is an effective component of complex therapy of polyneuropathy in children with diabetes type 1].

PubMed

Smirnov, K V; Smirnova, Yu V; Kulikov, V P; Nazarkina, O M

2018-01-01

To study the effectiveness of respiratory hypercapnic-hypoxic training in complex treatment of neuropathy due to diabetes type 1. Fifty children, 31 girls and 19 boys, were examined. The inclusion criteria were the presence of polyneuropathy, verified on the basis of clinical data and electromyographic changes. The patients were divided into 2 groups: the main group (n=25, 15 girls and 10 boys, mean age 12.9±1.8 years (M±SD) and the comparison group (n=25, 16 girls and 9 boys, mean age 13.2±2.0 years). Patients of the main group, along with standard therapy received respiratory hypercapnic-hypoxic training. The positive clinical and neurophysiological dynamics was noted in both groups, with more significant changes in children after respiratory training. Hypercapnic exercises significantly contribute to the pathogenetic therapy of diabetes mellitus and polyneuropathy in this disease, have a significant clinical effects reducing serum concentrations of fasting glucose and severity of neurological deficit scores on the NIS-LL, increasing the speed of conduction of excitation through the nerves, reducing the residual latency of EMG activity.

Efficacy and Safety of Daikenchuto for Constipation and Dose-Dependent Differences in Clinical Effects.

PubMed

Hirose, Tatsuya; Shinoda, Yasutaka; Kuroda, Ayaka; Yoshida, Aya; Mitsuoka, Machiko; Mori, Kouki; Kawachi, Yuki; Moriya, Akihiro; Tanaka, Kouji; Takeda, Atsuko; Yoshimura, Tomoaki; Sugiyama, Tadashi

2018-01-01

Daikenchuto (DKT) is a Kampo medicine used for the treatment of constipation. In this study, we evaluated the effectiveness of DKT against constipation. Thirty-three patients administered DKT for constipation were selected and divided into low-dose (7.5 g DKT; n = 22) and high-dose (15 g DKT; n = 11) groups. We retrospectively evaluated weekly defaecation frequency, side effects, and clinical laboratory data. Median defaecation frequencies after DKT administration (5, 5.5, 5, and 8 for the first, second, third, and fourth weeks, resp.) were significantly higher than that before DKT administration (2) in all 33 cases ( P < 0.01). One case (3%) of watery stool, one case of loose stools (3%), and no cases of abdominal pain (0%) were observed. Median defaecation frequencies in the high-dose group (7 and 9) were significantly higher than those in the low-dose group (4 and 3) in the first ( P = 0.0133) and second ( P = 0.0101) weeks, respectively. There was no significant change in clinical laboratory values. We suggest that DKT increases defaecation frequency and is safe for treating constipation.

Interventions Delivered in Clinical Settings are Effective in Reducing Risk of HIV Transmission Among People Living with HIV: Results from the Health Resources and Services Administration (HRSA)’s Special Projects of National Significance Initiative

PubMed Central

Shade, Starley B.; Rose, Carol Dawson; Koester, Kimberly; Maiorana, Andre; Malitz, Faye E.; Bie, Jennifer; Kang-Dufour, Mi-Suk; Morin, Stephen F.

2010-01-01

To support expanded prevention services for people living with HIV, the US Health Resources and Services Administration (HRSA) sponsored a 5-year initiative to test whether interventions delivered in clinical settings were effective in reducing HIV transmission risk among HIV-infected patients. Across 13 demonstration sites, patients were randomized to one of four conditions. All interventions were associated with reduced unprotected vaginal and/or anal intercourse with persons of HIV-uninfected or unknown status among the 3,556 participating patients. Compared to the standard of care, patients assigned to receive interventions from medical care providers reported a significant decrease in risk after 12 months of participation. Patients receiving prevention services from health educators, social workers or paraprofessional HIV-infected peers reported significant reduction in risk at 6 months, but not at 12 months. While clinics have a choice of effective models for implementing prevention programs for their HIV-infected patients, medical provider-delivered methods are comparatively robust. PMID:20229132

Experimental study on the clinical effects of Xiaoru Sanjie Jiaonang on mammary glands hyperplasia and ki-67

PubMed Central

Zheng, Zi-Hao; Liu, Lin; Zou, Shi-Fang; Xu, Yu-Ting; Chen, Cui-Cui; Liang, Wen-Long; Guo, Bao-Liang; Wang, Yu; Zhu, Kai-Yuan; Liu, Jie-Na; Xu, Dan-Dan; Wang, Ji-Yan; Lin, Jia-Yan; Liu, Li; Zhang, Jian Guo; Chen, Xi

2018-01-01

Objective: This study aims to observe the effect and mechanism of Xiaoru Sanjie Jiaonang (XRSJ) on the treatment of mammary gland hyperplasia, and provide a theoretical basis and clinical evidence for clinical expansion. Methods: Japanese white rabbits were randomly divided into three groups: high-, middle- and low-dose groups; Xiaoyao Pill group; model control group; normal control group. The observation points were as follows: before XRSJ administration, three months after XRSJ administration, and three months after XRSJ discontinuance. Changes in breast height, morphological changes of the mammary gland under a light and electron microscope, and the expression of ki-67 were observed. At the same time, patients diagnosed with mammary gland hyperplasia at an Outpatient Clinic were selected and divided into treatment groups. These patients received XRSJ and Xiaoyao Pills, respectively, for one month, while patients in the control group did not receive any drug treatment. Clinical efficacy was observed while rechecking at the Outpatient Clinic after three months. Treatment with a therapeutic dose of XRSJ could significantly reduce breast height, decrease the number of lobules and acini in hyperplastic mammary glands and the layer number of ductal glandular epithelial cells, substantially lower the content of serum estradiol (E2), significantly downregulate the expression of ki-67 protein in mammary tissues, and inhibit mammary gland hyperplasia. Conclusion: XRSJ treatment can relieve mammary tissue hyperplastic lesions, reduce E2 levels and downregulate the expression of ki-67. It has a significant therapeutic effect on mammary gland hyperplasia. PMID:29636873

Review of clinical and laboratory experiences with molindone hydrochloride.

PubMed

Claghorn, J L

1985-08-01

The literature concerning the pharmacokinetics, pharmacodynamics, receptor physiology, and clinical use of molindone is reviewed. Unanswered questions about the drug are addressed. Although molindone is reputed to have a short half-life (1.5 hours), clinical observations report a prolonged effect from a once-daily dose. Early in treatment, some patients show intolerance due to akathisia or extrapyramidal symptoms. This may be withdrawal dyskinesia due to discontinuation of another drug or an early adverse effect of molindone. Different effects on dopamine receptors have been described, but the significance of these properties for the development of tardive dyskinesia remains unclear.

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.

Osmotherapy for intracranial hypertension: mannitol versus hypertonic saline.

PubMed

Fink, Matthew E

2012-06-01

Hyperosmolar therapy is one of the core medical treatments for brain edema and intracranial hypertension, but controversy exists regarding the use of the most common agents, mannitol, and hypertonic saline. This article describes the relative merits and adverse effects of these agents using the best available clinical evidence. Mannitol is effective and has been used for decades in the treatment of traumatic brain injury, but it may precipitate acute renal failure if serum osmolarity exceeds 320 mOsm/L. Hypertonic saline appears to be safe, and serum sodium has been elevated to as high as 180 mEq/L in clinical settings without significant neurologic, cardiac, or renal injury. In small comparative trials both agents are effective and no clinically significant difference has been noted, but a properly powered trial has not yet been performed. Both mannitol and hypertonic saline are effective and have an acceptable risk profile for use in the treatment of elevated intracranial pressure secondary to brain edema.

The clinical and cost effectiveness of bee honey dressing in the treatment of diabetic foot ulcers.

PubMed

Moghazy, A M; Shams, M E; Adly, O A; Abbas, A H; El-Badawy, M A; Elsakka, D M; Hassan, S A; Abdelmohsen, W S; Ali, O S; Mohamed, B A

2010-09-01

Honey is known, since antiquity, as an effective wound dressing. Emergence of resistant strains and the financial burden of modern dressings, have revived honey as cost-effective dressing particularly in developing countries. Its suitability for all stages of wound healing suggests its clinical effectiveness in diabetic foot wound infections. Thirty infected diabetic foot wounds were randomly selected from patients presenting to Surgery Department, Suez Canal University Hospital, Ismailia, Egypt. Honey dressing was applied to wounds for 3 months till healing, grafting or failure of treatment. Changes in grade and stage of wounds, using University of Texas Diabetic Wound Classification, as well as surface area were recorded weekly. Bacterial load was determined before and after honey dressing. Complete healing was significantly achieved in 43.3% of ulcers. Decrease in size and healthy granulation was significantly observed in another 43.3% of patients. Bacterial load of all ulcers was significantly reduced after the first week of honey dressing. Failure of treatment was observed in 6.7% of ulcers. This study proves that commercial clover honey is a clinical and cost-effective dressing for diabetic wound in developing countries. It is omnipresence and concordance with cultural beliefs makes it a typical environmentally based method for treating these conditions. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

Patient Expectancy as a Mediator of Placebo Effects in Antidepressant Clinical Trials.

PubMed

Rutherford, Bret R; Wall, Melanie M; Brown, Patrick J; Choo, Tse-Hwei; Wager, Tor D; Peterson, Bradley S; Chung, Sarah; Kirsch, Irving; Roose, Steven P

2017-02-01

Causes of placebo effects in antidepressant trials have been inferred from observational studies and meta-analyses, but their mechanisms have not been directly established. The goal of this study was to examine in a prospective, randomized controlled trial whether patient expectancy mediates placebo effects in antidepressant studies. Adult outpatients with major depressive disorder were randomly assigned to open or placebo-controlled citalopram treatment. Following measurement of pre- and postrandomization expectancy, participants were treated with citalopram or placebo for 8 weeks. Independent samples t tests determined whether patient expectancy differed between the open and placebo-controlled groups, and mixed-effects models assessed group effects on Hamilton Depression Rating Scale (HAM-D) scores over time while controlling for treatment assignment. Finally, mediation analyses tested whether between-group differences in patient expectancy mediated the group effect on HAM-D scores. Postrandomization expectancy scores were significantly higher in the open group (mean=12.1 [SD=2.1]) compared with the placebo-controlled group (mean=11.0 [SD=2.0]). Mixed-effects modeling revealed a significant week-by-group interaction, indicating that HAM-D scores for citalopram-treated participants declined at a faster rate in the open group compared with the placebo-controlled group. Patient expectations postrandomization partially mediated group effects on week 8 HAM-D. Patient expectancy is a significant mediator of placebo effects in antidepressant trials. Expectancy-related interventions should be investigated as a means of controlling placebo responses in antidepressant clinical trials and improving patient outcome in clinical treatment.

CLINICAL outcomes and loss to follow-up among people living with HIV participating in the NAMWEZA intervention in Dar es Salaam, Tanzania: a prospective cohort study.

PubMed

Siril, Hellen N; Kaaya, Sylvia F; Smith Fawzi, Mary Kay; Mtisi, Expeditho; Somba, Magreat; Kilewo, Japheth; Mugusi, Ferdinand; Minja, Anna; Kaale, Anna; Todd, Jim

2017-03-28

Psychosocial factors have been linked with loss to follow-up (LTFU) and clinical outcomes among people living with HIV (PLH), however little is known about the effect of psychosocial support on LTFU among PLH in treatment and care. The purpose of this study was to explore the effect of NAMWEZA ("Yes, together we can") friends' psychosocial support intervention on clinical outcomes and LTFU among PLH. NAMWEZA is based on a novel program using "appreciative inquiry", positive psychology approaches to empower, promote positive attitudes and foster hope. PLH participating in the NAMWEZA intervention in HIV care clinics in Dar es Salaam Tanzania were compared with non-exposed PLH obtained from facilities that routinely collect clinical information and both followed longitudinally for 24 months. Baseline sociodemographic, clinical measures (CD4 cell count, hemoglobin (HGB), weight), and LTFU measures were collected. Chi square, Fisher's exact tests, and t-tests were used to compare the frequencies for categorical variables and the means of continuous variables from the intervention and the comparison groups to identify variables that were significantly different across the two groups. Random effects models were performed to examine the bivariate associations between the intervention status and clinical outcomes. At the end of 24 months of follow-up mean CD4 count and HGB levels increased significantly in both intervention and comparison groups (p = 0.009 and p < 0.0001, respectively). Weight increased significantly only in the intervention group (p = 0.003). Cumulative LTFU was three times higher in the comparison compared to the intervention (p < 0.001) group. Having a low CD4 count, extremes of weight, low HGB, younger age, and male gender were significantly associated with LTFU among the unexposed group, while being on ART for duration of 12 months or more was protective against LTFU in those intervened. Among PLH on ART, exposed or not exposed to NAMWEZA intervention, clinical care outcomes improved over time. LTFU was much higher in the comparison group with factors commonly known to predict LTFU only apparent in the comparison group. NAMWEZA could be a promising peer-facilitated model to reduce LTFU among PLH in care that can be integrated in ART services; however, more research is needed to evaluate its longer term effects.

Tissue Engineering of the Urethra: A Systematic Review and Meta-analysis of Preclinical and Clinical Studies.

PubMed

Versteegden, Luuk R M; de Jonge, Paul K J D; IntHout, Joanna; van Kuppevelt, Toin H; Oosterwijk, Egbert; Feitz, Wout F J; de Vries, Rob B M; Daamen, Willeke F

2017-10-01

Urethra repair by tissue engineering has been extensively studied in laboratory animals and patients, but is not routinely used in clinical practice. To systematically investigate preclinical and clinical evidence of the efficacy of tissue engineering for urethra repair in order to stimulate translation of preclinical studies to the clinic. A systematic search strategy was applied in PubMed and EMBASE. Studies were independently screened for relevance by two reviewers, resulting in 80 preclinical and 23 clinical studies of which 63 and 13 were selected for meta-analysis to assess side effects, functionality, and study completion. Analyses for preclinical and clinical studies were performed separately. Full circumferential and inlay procedures were assessed independently. Evaluated parameters included seeding of cells and type of biomaterial. Meta-analysis revealed that cell seeding significantly reduced the probability of encountering side effects in preclinical studies. Remarkably though, cells were only sparsely used in the clinic (4/23 studies) and showed no significant reduction of side effects. ln 21 out of 23 clinical studies, decellularized templates were used, while in preclinical studies other biomaterials showed promising outcomes as well. No direct comparison to current clinical practice could be made due to the limited number of randomized controlled studies. Due to a lack of controlled (pre)clinical studies, the efficacy of tissue engineering for urethra repair could not be determined. Meta-analysis outcome measures were similar to current treatment options described in literature. Surprisingly, it appeared that favorable preclinical results, that is inclusion of cells, were not translated to the clinic. Improved (pre)clinical study designs may enhance clinical translation. We reviewed all available literature on urethral tissue engineering to assess the efficacy in preclinical and clinical studies. We show that improvements to (pre)clinical study design is required to improve clinical translation of tissue engineering technologies. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

The Cognitive Effects of Antidepressants in Major Depressive Disorder: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

PubMed Central

Rosenblat, Joshua D; Kakar, Ron

2016-01-01

Background: Cognitive dysfunction is often present in major depressive disorder (MDD). Several clinical trials have noted a pro-cognitive effect of antidepressants in MDD. The objective of the current systematic review and meta-analysis was to assess the pooled efficacy of antidepressants on various domains of cognition in MDD. Methods: Trials published prior to April 15, 2015, were identified through searching the Cochrane Central Register of Controlled Trials, PubMed, Embase, PsychINFO, Clinicaltrials.gov, and relevant review articles. Data from randomized clinical trials assessing the cognitive effects of antidepressants were pooled to determine standard mean differences (SMD) using a random-effects model. Results: Nine placebo-controlled randomized trials (2 550 participants) evaluating the cognitive effects of vortioxetine (n = 728), duloxetine (n = 714), paroxetine (n = 23), citalopram (n = 84), phenelzine (n = 28), nortryptiline (n = 32), and sertraline (n = 49) were identified. Antidepressants had a positive effect on psychomotor speed (SMD 0.16; 95% confidence interval [CI] 0.05–0.27; I2 = 46%) and delayed recall (SMD 0.24; 95% CI 0.15–0.34; I2 = 0%). The effect on cognitive control and executive function did not reach statistical significance. Of note, after removal of vortioxetine from the analysis, statistical significance was lost for psychomotor speed. Eight head-to-head randomized trials comparing the effects of selective serotonin reuptake inhibitors (SSRIs; n = 371), selective serotonin and norepinephrine reuptake inhibitors (SNRIs; n = 25), tricyclic antidepressants (TCAs; n = 138), and norepinephrine and dopamine reuptake inhibitors (NDRIs; n = 46) were identified. No statistically significant difference in cognitive effects was found when pooling results from head-to-head trials of SSRIs, SNRIs, TCAs, and NDRIs. Significant limitations were the heterogeneity of results, limited number of studies, and small sample sizes. Conclusions: Available evidence suggests that antidepressants have a significant positive effect on psychomotor speed and delayed recall. PMID:26209859

The Effect of Aroma Hand Massage Therapy for People with Dementia.

PubMed

Yoshiyama, Kazuyo; Arita, Hideko; Suzuki, Jinichi

2015-12-01

Clinical aromatherapy is a complementary therapy that may be very helpful for elderly dementia care. Aromatherapy may reduce the behavioral and psychological symptoms of dementia (BPSD), improve quality of care, and thus improve the quality of life for people with dementia. In this pilot study, aroma hand massage therapy was used for elderly patients in a medical institution in Japan. The study assessed the effectiveness and safety of clinical aromatherapy as part of routine integrative care among people with dementia in a clinical care setting. The randomized, crossover pilot trials were performed among 14 patients with mild-to-moderate dementia older than age 65 years living in a nursing home in Nara, Japan. Participants were divided into two groups and offered, alternately, control therapy and clinical aromatherapy 3 times a week for the 4-week trials. The effects on BPSD and activities of daily living (ADLs) were evaluated quantitatively before and after the study and 4 weeks after the study ended as a follow-up. Observation records were also collected to obtain qualitative data. The quantitative data showed that neither therapy significantly improved the BPSD or ADL results. The qualitative data were classified into four main categories-mood, behavior, verbal communication, and nonverbal communication-reflecting the positive experiences of participants during both therapies. No harmful reactions or changes in medication occurred during the study. This pilot study demonstrated that clinical aromatherapy was clinically safe but did not lead to statistically significant improvements in BPSD or ADL among people with dementia. Further research on therapeutic effects is needed to develop high-quality care with clinical aromatherapy for elderly patients with dementia in Japan and to fully establish evidence for effective and safe practice in health care institutions.

The Flynn effect and memory function.

PubMed

Baxendale, Sallie

2010-08-01

The Flynn effect refers to the steady increase in IQ that appears to date back at least to the inception of modern-day IQ tests. This study examined the possible Flynn effects on clinical memory tests involving the learning and recall of verbal and nonverbal material. Comparisons of the age-related norms on the list learning and design learning tasks from the Adult Memory and Information Processing Battery (AMIPB), published in 1985, and its successor, the BIRT (Brain Injury Rehabilitation Trust) Memory and Information Processing Battery (BMIPB) published in 2007, indicate that there is a significant Flynn effect on tests of memory function. This effect appears to be material specific with statistically significant improvements in all scores on tests involving the learning and recall of visual material in every age range evident over a 22-year period. Verbal memory abilities appear to be relatively stable with no significant differences between the scores in the majority of age ranges. The ramifications for the clinical interpretation of these tests are discussed.

[Clinical observation of modified Da Chaihu decoction in treating essential hypertension with anxiety].

PubMed

Zhang, Xiang-Dong; Cheng, Wang-Qiang; Wang, Yong-Gang; Zhang, Zheng

2017-06-01

To observe the clinical efficacy of modified Da Chaihu decoction in treating essential hypertension with anxiety, the randomized, controlled, clinical trial was performed in this study. One hundred and twenty-six hypertensive patients with anxiety meeting the inclusive criteria were randomized into the treatment group and the control group. All of the included patients in the above 2 groups were treated by amlodipine besylate tablets. Patients in the treatment group were given Chinese herbal medicine modified Da Chaihu decoction every day. And patients in the control group were given flupentixol and melitracen tablets. The treatment course was 4 weeks. Blood pressure, the score of traditional Chinese medicine syndrome, blood lipids, C reactive protein, the Hamilton anxiety scale score and adverse effects were observed. It has been identified that, both systolic and diastolic blood pressure were significantly reduced (P<0.05). However, no significant difference between the treatment group and the control group was identified. For traditional Chinese medicine syndrome, it was significantly improved in the treatment group (P<0.05). For blood lipids, TC, TG, HDL-C, and LDL-C were significantly improved in the treatment group (P<0.05). After treatment, only TC was significantly reduced in the treatment group when compared to the control group (P<0.05). For C reactive protein, it was significantly reduced in the treatment group after treatment (P<0.05). For anxiety, no significant difference between the treatment group and the control group on the Hamilton anxiety scale score was identified. For adverse effect, no severe adverse effect was identified in this study. The modified Da Chaihu decoction maybe effective in the treatment of essential hypertension with anxiety. In addition to a certain role in lowering blood pressure, the modified Da Chaihu decoction was also effective in improving traditional Chinese medicine syndrome and blood lipids, reducing the level of C reactive protein, relieving anxiety with little adverse effect. Copyright© by the Chinese Pharmaceutical Association.

Does the decision in a validation process of a surrogate endpoint change with level of significance of treatment effect? A proposal on validation of surrogate endpoints.

PubMed

Sertdemir, Y; Burgut, R

2009-01-01

In recent years the use of surrogate end points (S) has become an interesting issue. In clinical trials, it is important to get treatment outcomes as early as possible. For this reason there is a need for surrogate endpoints (S) which are measured earlier than the true endpoint (T). However, before a surrogate endpoint can be used it must be validated. For a candidate surrogate endpoint, for example time to recurrence, the validation result may change dramatically between clinical trials. The aim of this study is to show how the validation criterion (R(2)(trial)) proposed by Buyse et al. are influenced by the magnitude of treatment effect with an application using real data. The criterion R(2)(trial) proposed by Buyse et al. (2000) is applied to the four data sets from colon cancer clinical trials (C-01, C-02, C-03 and C-04). Each clinical trial is analyzed separately for treatment effect on survival (true endpoint) and recurrence free survival (surrogate endpoint) and this analysis is done also for each center in each trial. Results are used for standard validation analysis. The centers were grouped by the Wald statistic in 3 equal groups. Validation criteria R(2)(trial) were 0.641 95% CI (0.432-0.782), 0.223 95% CI (0.008-0.503), 0.761 95% CI (0.550-0.872) and 0.560 95% CI (0.404-0.687) for C-01, C-02, C-03 and C-04 respectively. The R(2)(trial) criteria changed by the Wald statistics observed for the centers used in the validation process. Higher the Wald statistic groups are higher the R(2)(trial) values observed. The recurrence free survival is not a good surrogate for overall survival in clinical trials with non significant treatment effects and moderate for significant treatment effects. This shows that the level of significance of treatment effect should be taken into account in validation process of surrogate endpoints.

Bedtime Blood Pressure Chronotherapy Significantly Improves Hypertension Management.

PubMed

Hermida, Ramón C; Ayala, Diana E; Fernández, José R; Mojón, Artemio; Crespo, Juan J; Ríos, María T; Smolensky, Michael H

2017-10-01

Consistent evidence of numerous studies substantiates the asleep blood pressure (BP) mean derived from ambulatory BP monitoring (ABPM) is both an independent and a stronger predictor of cardiovascular disease (CVD) risk than are daytime clinic BP measurements or the ABPM-determined awake or 24-hour BP means. Hence, cost-effective adequate control of sleep-time BP is of marked clinical relevance. Ingestion time, according to circadian rhythms, of hypertension medications of 6 different classes and their combinations significantly improves BP control, particularly sleep-time BP, and reduces adverse effects. Copyright © 2017 Elsevier Inc. All rights reserved.

Tracking medication changes to assess outcomes in comparative effectiveness research: A bipolar CHOICE study.

PubMed

Reilly-Harrington, Noreen A; Sylvia, Louisa G; Rabideau, Dustin J; Gold, Alexandra K; Deckersbach, Thilo; Bowden, Charles L; Bobo, William V; Singh, Vivek; Calabrese, Joseph R; Shelton, Richard C; Friedman, Edward S; Thase, Michael E; Kamali, Masoud; Tohen, Mauricio; McInnis, Melvin G; McElroy, Susan L; Ketter, Terence A; Kocsis, James H; Kinrys, Gustavo; Nierenberg, Andrew A

2016-11-15

Comparative effectiveness research uses multiple tools, but lacks outcome measures to assess large electronic medical records and claims data. Aggregate changes in medications in response to clinical need may serve as a surrogate outcome measure. We developed the Medication Recommendation Tracking Form (MRTF) to record the frequency, types, and reasons for medication adjustments in order to calculate Necessary Clinical Adjustments (NCAs), medication adjustments to reduce symptoms, maximize treatment response, or address problematic side effects. The MRTF was completed at every visit for 482 adult patients in Bipolar CHOICE, a 6-month randomized comparative effectiveness trial. Responders had significantly fewer NCAs compared to non-responders. NCAs predicted subsequent response status such that every additional NCA during the previous visit decreased a patient's odds of response by approximately 30%. Patients with more severe symptoms had a greater number of NCAs at the subsequent visit. Patients with a comorbid anxiety disorder demonstrated a significantly higher rate of NCAs per month than those without a comorbid anxiety disorder. Patients with greater frequency, intensity, and interference of side effects had higher rates of NCAs. Participants with fewer NCAs reported a higher quality of life and decreased functional impairment. The MRTF has not been examined in community clinic settings and did not predict response more efficiently than the Clinical Global Impression-Bipolar Version (CGI-BP). The MRTF is a feasible proxy of clinical outcome, with implications for clinical training and decision-making. Analyses of big data could use changes in medications as a surrogate outcome measure. Copyright © 2016 Elsevier B.V. All rights reserved.

The effect of mentoring on clinical perioperative competence in operating room nursing students.

PubMed

Mirbagher Ajorpaz, Neda; Zagheri Tafreshi, Mansoureh; Mohtashami, Jamileh; Zayeri, Farid; Rahemi, Zahra

2016-05-01

The aim of this study was to investigate the effects of mentoring on the clinical perioperative competence of nursing operating room students in Iran. Mentoring is an essential part of clinical education, which has been studied in different populations of students. However, there is a need to assess its effectiveness in operating room students' competence. A randomised controlled trial was performed. Sixty nursing operating room students were randomly assigned to experimental and control groups. Both the control and experimental groups had routine training in the form of faculty supervision. The experimental group had an additional mentoring program. Using the Persian Perceived Perioperative Competence Scale-Revised, clinical competence was compared between the two groups, before and after the intervention. Using SPSS 19, descriptive and inferential statistics, including chi-square and t-tests, were conducted. In the experimental group, the difference between the mean scores of clinical competence before (19·43 ± 2·80) and after (27·86 ± 1·87) the intervention was significant (p ≤ 0·001). After intervention, the difference between the mean scores of the control (3·9 ± 0·15) and experimental (8·61 ± 0·68) groups was significant (p ≤ 0·003). Findings affirmed the positive effect of mentorship programmes on clinical competence in nursing operating room students. Mentoring is an effective method for preparing nursing students in practice. Health care systems may improve as a result of staff-student relationships that ultimately increase the quality care for patients. © 2016 John Wiley & Sons Ltd.

Effect of carprofen on hemostatic variables in dogs.

PubMed

Hickford, F H; Barr, S C; Erb, H N

2001-10-01

To evaluate the effect of carprofen on hemostatic variables in clinically normal dogs. 12 clinically normal Labrador Retrievers. 10 dogs (6 females, 4 males) received carprofen (2.2 mg/kg of body weight, PO, q 12 h) for 5 days. Two dogs (untreated control group; 1 female, 1 male) did not receive carprofen. Hemostatic variables (platelet count, activated partial thromboplastin time, prothrombin time, fibrinogen, platelet aggregation, and bleeding time) were assessed for all dogs prior to treatment, on day 5 of treatment, and 2 and 7 days after discontinuation of the drug (days 7 and 12). Serum biochemical variables and Hct were assessed prior to treatment and on days 5 and 12. In dogs receiving carprofen, platelet aggregation was significantly decreased, and onset of aggregation was significantly delayed on days 5, 7, and 12, compared with pretreatment values. Activated partial thromboplastin time was significantly increased on days 5, 7, and 12 over pretreatment values in treated dogs, but values remained within reference ranges. Significant differences were not detected in buccal mucosal bleeding time, other serum biochemical and hemostatic variables, or Hct, compared with pretreatment values and the internal control group. Administration of carprofen for 5 days causes minor but not clinically important alterations in hemostatic and serum biochemical variables in clinically normal Labrador Retrievers. Carprofen is commonly used to treat osteoarthritis and chronic pain in dogs, but prior to this study, its effect on platelet aggregation and hemostatic variables was unknown.

Peritoneal adhesions: etiology, pathophysiology, and clinical significance. Recent advances in prevention and management.

PubMed

Liakakos, T; Thomakos, N; Fine, P M; Dervenis, C; Young, R L

2001-01-01

To summarize the most common etiologic factors and describe the pathophysiology in the formation of peritoneal adhesions, to outline their clinical significance and consequences, and to evaluate the pharmacologic, mechanical, and surgical adjuvant strategies to minimize peritoneal adhesion formation. We performed an extensive MEDLINE search of the internationally published English literature of all medical and epidemiological journal articles, textbooks, scientific reports, and scientific journals from 1940 to 1997. We also reviewed reference lists in all the articles retrieved in the search as well as those of major texts regarding intraperitoneal postsurgical adhesion formation. All sources identified were reviewed with particular attention to risk factors, pathophysiology, clinical manifestations, various methods, and innovative techniques for effectively and safely reducing the formation of postsurgical adhesions. The formation of postoperative peritoneal adhesions is an important complication following gynecological and general abdominal surgery, leading to clinical and significant economical consequences. Adhesion occur in more than 90% of the patients following major abdominal surgery and in 55-100% of the women undergoing pelvic surgery. Small-bowel obstruction, infertility, chronic abdominal and pelvic pain, and difficult reoperative surgery are the most common consequences of peritoneal adhesions. Despite elaborate efforts to develop effective strategies to reduce or prevent adhesions, their formation remains a frequent occurrence after abdominal surgery. Until additional information and findings from future clinical investigations exist, only a meticulous surgical technique can be advocated in order to reduce unnecessary morbidity and mortality rates from these untoward effects of surgery. Copyright 2001 S. Karger AG, Basel

The treatment of melasma by silymarin cream

PubMed Central

2012-01-01

Background Melasma is an acquired increased pigmentation of the skin characterized by symmetrical and confluent grey-brown patches usually on the areas of the face exposed to the sun. Silymarin strongly prevents photocarcinogenesis, and significantly prevented melanin production. The objectives of this study were the assessment of safety and efficacy of topical Silymain (SM) cream in a double-blind placebo controlled study for treatment of melasma patients. Methods Experimentally on 24 Albino rabbits were randomly divided into 4 equal groups. [A] No treatment, [B] received placebo, [C] treated with SM cream (0.1), & [D] treated by SM (0.2), were applied topically before UV sun light exposure for 30 days, assessed clinically & tissue pathology. Clinically on 96 adults diagnosed with melasma randomized to three equal groups to receive one of the tested drugs applied twice daily for 4 weeks, evaluated by the response; lesion size, melasma area and severity index score, Physician global assessment, and subjective assessment. Results The Clinical and histopathology observations were reduced significantly in SM groups. Clinically; all patients showed significant excellent pigment improvement & lesion size reduction with SM treatments from the 1st week. All patients were fully satisfied 100%. No side effects were observed. Conclusions Silymarin showed tremendous improvement of melasma in a dose-dependent manner, and was effective in prevention of skin damage caused by U.V. sunlight. It is a safe new candidate effective treatment for melasma. Trial registration Australian New Zealand Clinical Trials Registry - ACTRN12612000602820 PMID:23031632

Women with breast cancer report substantially more disease- and treatment-related side or late effects than registered by clinical oncologists: a cross-sectional study of a standard follow-up program in an oncological department.

PubMed

Ellegaard, Mai-Britt Bjørklund; Grau, Cai; Zachariae, Robert; Jensen, Anders Bonde

2017-08-01

Follow-up after breast cancer treatment is standard due to the risk of development of new primary cancers and recurrent disease. The aim of the present study was to evaluate a standard follow-up program in an oncological department by assessing: (1) Symptoms or signs of new primary cancer or recurrent disease, (2) Disease- and treatment-related physical and psychosocial side or late effects, and (3) relevant actions by oncology staff. In a cross-sectional study, 194 women who came for follow-up visit after treatment for primary surgery were included. The clinical oncologists registered symptoms and signs of recurrent disease or new primary cancer. Side or late effects were both assessed by patient and the clinical oncologists. Loco-regional or distant signs of recurrent disease were suspected in eight (5%) patients. Further examinations revealed no disease recurrence. Most patients (93%) reported some degree of side or late effects. Statistically significant more side or late effects were reported by the women (average: 6.9) than registered by the clinical oncologists (average: 2.4), p < 0.001. The three most often patient-reported side or late effects were hot flushes (35%), fatigue (32%), and sleep disturbance (31%). None of the scheduled or additional visits resulted in detection of recurrent disease. Furthermore, the majority of patients reported side or late effects. Statistically significant more women reported side or late effects than registered by the clinical oncologists. This suggests the need for rethinking of the follow-up programs with more emphasis upon side or late effects of the treatment.

Comparative effectiveness and acceptability of home-based and clinic-based sampling methods for sexually transmissible infections screening in females aged 14-50 years: a systematic review and meta-analysis.

PubMed

Odesanmi, Tolulope Y; Wasti, Sharada P; Odesanmi, Omolola S; Adegbola, Omololu; Oguntuase, Olubukola O; Mahmood, Sajid

2013-12-01

Home-based sampling is a strategy to enhance uptake of sexually transmissible infection (STI) screening. This review aimed to compare the screening uptake levels of home-based self-sampling and clinic-based specimen collection for STIs (chlamydia (Chlamydia trachomatis), gonorrhoea (Neisseria gonorrhoeae) and trichomoniasis) in females aged 14-50 years. Acceptability and effect on specimen quality were determined. Sixteen electronic databases were searched from inception to September 2012. Randomised controlled trials (RCTs) comparing the uptake levels of home-based self-sampling and clinic-based sampling for chlamydia, gonorrhoea and trichomoniasis in females aged 14-50 years were eligible for inclusion. The risk of bias in the trials was assessed. Risk ratios (RRs) for dichotomous outcomes were meta-analysed. Of 3065 papers, six studies with seven RCTs contributed to the final review. Compared with clinic-based methods, home-based screening increased uptake significantly (P=0.001-0.05) in five trials and was substantiated in a meta-analysis (RR: 1.55; 95% confidence interval: 1.30-1.85; P=0.00001) of two trials. In three trials, a significant preference for home-based testing (P=0.001-0.05) was expressed. No significant difference was observed in specimen quality. Sampling was rated as easy by a significantly higher number of women (P=0.01) in the clinic group in one trial. The review provides evidence that home-based testing results in greater uptake of STI screening in females (14-50 years) than clinic-based testing without compromising quality in the developed world. Home collection strategies should be added to clinic-based screening programs to enhance uptake.

Influence of clinical mastitis and its treatment outcome on reproductive performance in crossbred cows: A retrospective study.

PubMed

Kumar, Narender; Manimaran, A; Sivaram, M; Kumaresan, A; Jeyakumar, S; Sreela, L; Mooventhan, P; Rajendran, D

2017-05-01

Evaluation of the effect of clinical mastitis (CM) and its treatment outcome on the reproductive performance in crossbred cows retrospectively. Datasets of 835 lactating cows affected with CM during a period of 12 years (2001-2012) were considered for this study. Mastitis treatment related data and reproductive parameters such as days to first detected heat (DTFDH), days to first insemination (DTFI), days open (DO), and number of services per conception (SC) were collected from mastitis treatment and artificial insemination registers, respectively. Data were analyzed by ANOVA using SPSS 20 software. The means were compared with the Duncan's multiple comparison post-hoc test. CM affected cows had significantly (p<0.05) higher DTFDH, DTFI, DO and SC compared to clinically healthy cows. Cows diagnosed with a single episode of CM had significantly (p<0.05) delayed DTFDH while, DO and SC were significantly higher (p<0.05) in cows diagnosed by multiple episodes of CM. SC was significantly (p<0.05) higher in cows diagnosed with both relapse and recurrence. Severe CM affected cows had significantly (p<0.05) altered reproductive parameters. The reproductive parameters were altered to high extent when CM occurred during the breeding period. CM-affected cows had higher DTFDH, DTFI, DO and SC compared to clinically healthy cows. The negative effects of CM on reproduction parameters were higher when CM occurred during the breeding period.

Adaptive servo-ventilation therapy for patients with chronic heart failure in a confirmatory, multicenter, randomized, controlled study.

PubMed

Momomura, Shin-Ichi; Seino, Yoshihiko; Kihara, Yasuki; Adachi, Hitoshi; Yasumura, Yoshio; Yokoyama, Hiroyuki; Wada, Hiroshi; Ise, Takayuki; Tanaka, Koichi

2015-01-01

Adaptive servo-ventilation (ASV) therapy is expected to be novel nonpharmacotherapy with hemodynamic effects on patients with chronic heart failure (CHF), but sufficient evidence has not been obtained. A 24-week, open-label, randomized, controlled study was performed to confirm the cardiac function-improving effect of ASV therapy on CHF patients. At 39 institutions, 213 outpatients with CHF, whose left ventricular ejection fraction (LVEF) was <40% and who had mild to severe symptoms [New York Heart Association (NYHA) class: ≥II], were enrolled. After excluding 8 patients, 102 and 103 underwent ASV plus guideline-directed medical therapy (GDMT) [ASV group] and GDMT only [control group], respectively. The primary endpoint was LVEF, and the secondary endpoints were HF deterioration, B-type natriuretic peptide (BNP), and clinical composite response (CCR: NYHA class+HF deterioration). LVEF and BNP improved significantly at completion against the baseline values in the 2 groups. However, no significant difference was found between these groups. HF deterioration tended to be suppressed. The ASV group showed a significant improvement in CCR corroborated by significant improvements in NYHA class and ADL against the control group. Under the present study's conditions, ASV therapy was not superior to GDMT in the cardiac function-improving effect but showed a clinical status-improving effect, thus indicating a given level of clinical benefit.

Using Lean Thinking at an otorhinolaryngology outpatient clinic to improve quality of care.

PubMed

van Leijen-Zeelenberg, Janneke E; Brunings, Jan Wouter; Houkes, Inge; van Raak, Arno J A; Ruwaard, Dirk; Vrijhoef, Hubertus J M; Kremer, Bernd

2016-04-01

Although Lean Thinking has led to considerable improvement in a variety of healthcare settings, its effects on otorhinolaryngology remain underexposed. This study reports on how the implementation of Lean Thinking at an otorhinolaryngology outpatient clinic has affected patient and provider satisfaction, waste reduction, and organizational culture. Prospective before-and-after design. The 18-month prospective before-and-after design used mixed methods for data collection and analysis. A survey was conducted to measure satisfaction among patients and providers. Semistructured interviews were conducted to evaluate the effect of Lean Thinking on waste and organizational culture. During the project, 69 issues were posted on the Lean board. Improvements were made on 36 inefficiency issues, not all concerning a specific type of waste. Employees reported considerable improvement in transportation, motion, and waiting. Patient satisfaction was high both at baseline and follow-up and did not change significantly. The effects on provider satisfaction were slight; satisfaction with autonomy and participation decreased significantly, but satisfaction with communication increased significantly. The implementation of Lean Thinking at an otorhinolaryngology outpatient clinic reduced waste and increased provider satisfaction with communication. Although patient satisfaction did not change significantly, it cannot be concluded that the intervention had no effect on perceived quality of care. Other approaches to measure patients' perceptions should be considered. NA. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

An acceptance-oriented cognitive-behavioral therapy in multimodal rehabilitation: a pre-post test evaluation in highly distressed patients with rheumatic diseases.

PubMed

Vriezekolk, Johanna E; Eijsbouts, Agnes M M; van Lankveld, Wim G J M; Beenackers, Hanneke; Geenen, Rinie; van den Ende, Cornelia H M

2013-06-01

To examine the potential effectiveness of a multimodal rehabilitation program including an acceptance-oriented cognitive-behavioral therapy for highly distressed patients with rheumatic diseases. An observational study employing a one-group pre-post test design (N=25). The primary outcome was psychological distress. Secondary outcomes were quality of life, illness acceptance, and coping flexibility. Group pre-to-post and pre-to-12 months follow-up treatment changes were evaluated by paired-samples t-tests and Cohen's effect sizes (d). Individual changes were evaluated by the reliable change index (RCI) and clinically significant change (CSC) parameters. Significant effects were found post-treatment and maintained at 12 months in psychological distress (d>0.80), illness acceptance (d=1.48) and the SF-36 subscales role physical, vitality, and mental health (d ≥ 0.65). No significant effects were found for coping flexibility and the SF-36 subscales physical functioning, bodily pain, social functioning, and role emotional. Both a reliable (RCI) and clinically significant (CSC) improvement was observed for almost half of the highly distressed patients. The patients enrolled in the multimodal rehabilitation program showed improved psychological health status from pre to post-treatment. A randomized clinical trial is needed to confirm or refute the added value of an acceptance-oriented cognitive-behavioral therapy for highly distressed patients in rehabilitation. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Approaches for estimating minimal clinically important differences in systemic lupus erythematosus.

PubMed

Rai, Sharan K; Yazdany, Jinoos; Fortin, Paul R; Aviña-Zubieta, J Antonio

2015-06-03

A minimal clinically important difference (MCID) is an important concept used to determine whether a medical intervention improves perceived outcomes in patients. Prior to the introduction of the concept in 1989, studies focused primarily on statistical significance. As most recent clinical trials in systemic lupus erythematosus (SLE) have failed to show significant effects, determining a clinically relevant threshold for outcome scores (that is, the MCID) of existing instruments may be critical for conducting and interpreting meaningful clinical trials as well as for facilitating the establishment of treatment recommendations for patients. To that effect, methods to determine the MCID can be divided into two well-defined categories: distribution-based and anchor-based approaches. Distribution-based approaches are based on statistical characteristics of the obtained samples. There are various methods within the distribution-based approach, including the standard error of measurement, the standard deviation, the effect size, the minimal detectable change, the reliable change index, and the standardized response mean. Anchor-based approaches compare the change in a patient-reported outcome to a second, external measure of change (that is, one that is more clearly understood, such as a global assessment), which serves as the anchor. Finally, the Delphi technique can be applied as an adjunct to defining a clinically important difference. Despite an abundance of methods reported in the literature, little work in MCID estimation has been done in the context of SLE. As the MCID can help determine the effect of a given therapy on a patient and add meaning to statistical inferences made in clinical research, we believe there ought to be renewed focus on this area. Here, we provide an update on the use of MCIDs in clinical research, review some of the work done in this area in SLE, and propose an agenda for future research.

Amyloid-β--associated clinical decline occurs only in the presence of elevated P-tau.

PubMed

Desikan, Rahul S; McEvoy, Linda K; Thompson, Wesley K; Holland, Dominic; Brewer, James B; Aisen, Paul S; Sperling, Reisa A; Dale, Anders M

2012-06-01

To elucidate the relationship between the 2 hallmark proteins of Alzheimer disease (AD), amyloid-(Aβ) and tau, and clinical decline over time among cognitively normal older individuals. A longitudinal cohort of clinically and cognitively normal older individuals assessed with baseline lumbar puncture and longitudinal clinical assessments. Research centers across the United States and Canada. We examined 107 participants with a Clinical Dementia Rating (CDR) of 0 at baseline examination. Using linear mixed effects models, we investigated the relationship between cerebrospinal fluid (CSF) phospho-tau 181 (p-tau(181p)),CSF Aβ(1-42), and clinical decline as assessed using longitudinal change in global CDR, CDR-Sum of Boxes, and the Alzheimer Disease Assessment Scale-cognitive subscale. We found a significant relationship between decreased CSF Aβ(1-42) and longitudinal change in global CDR,CDR-Sum of Boxes, and Alzheimer Disease Assessment Scale-cognitive subscale in individuals with elevated CSFp-tau(181p). In the absence of CSF p-tau(181p), the effect of CSF Aβ(1-42) on longitudinal clinical decline was not significantly different from 0. In cognitively normal older individuals,A-associated clinical decline during a mean of 3 years may occur only in the presence of ongoing downstream neurodegeneration.

Short-term SSRI treatment normalises amygdala hyperactivity in depressed patients.

PubMed

Godlewska, B R; Norbury, R; Selvaraj, S; Cowen, P J; Harmer, C J

2012-12-01

Antidepressant drugs such as selective serotonin re-uptake inhibitors (SSRIs) remediate negative biases in emotional processing in depressed patients in both behavioural and neural outcome measures. However, it is not clear if these effects occur before, or as a consequence of, changes in clinical state. In the present study, we investigated the effects of short-term SSRI treatment in depressed patients on the neural response to fearful faces prior to clinical improvement in mood. Altogether, 42 unmedicated depressed patients received SSRI treatment (10 mg escitalopram daily) or placebo in a randomised, parallel-group design. The neural response to fearful and happy faces was measured on day 7 of treatment using functional magnetic resonance imaging. A group of healthy controls was imaged in the same way. Amygdala responses to fearful facial expressions were significantly greater in depressed patients compared to healthy controls. However, this response was normalised in patients receiving 7 days treatment with escitalopram. There was no significant difference in clinical depression ratings at 7 days between the escitalopram and placebo-treated patients. Our results suggest that short-term SSRI treatment in depressed patients remediates amygdala hyperactivity in response to negative emotional stimuli prior to clinical improvement in depressed mood. This supports the hypothesis that the clinical effects of antidepressant treatment may be mediated in part through early changes in emotional processing. Further studies will be needed to show if these early effects of antidepressant medication predict eventual clinical outcome.

Do team processes really have an effect on clinical performance? A systematic literature review.

PubMed

Schmutz, J; Manser, T

2013-04-01

There is a growing literature on the relationship between team processes and clinical performance. The purpose of this review is to summarize these articles and examine the impact of team process behaviours on clinical performance. We conducted a literature search in five major databases. Inclusion criteria were: English peer-reviewed papers published between January 2001 and May 2012, which showed or tried to show (i) a statistical relationship of a team process variable and clinical performance or (ii) an improvement of a performance variable through a team process intervention. Study quality was assessed using predefined quality indicators. For every study, we calculated the relevant effect sizes. We included 28 studies in the review, seven of which were intervention studies. Every study reported at least one significant relationship between team processes or an intervention and performance. Also, some non-significant effects were reported. Most of the reported effect sizes were large or medium. The study quality ranged from medium to high. The studies are highly diverse regarding the specific team process behaviours investigated and also regarding the methods used. However, they suggest that team process behaviours do influence clinical performance and that training results in increased performance. Future research should rely on existing theoretical frameworks, valid, and reliable methods to assess processes such as teamwork or coordination and focus on the development of adequate tools to assess process performance, linking them with outcomes in the clinical setting.

The effects of mobile applications in cardiopulmonary assessment education.

PubMed

Yoo, In-Young; Lee, Young-Mi

2015-02-01

Mobile applications can be used as effective simulations for nursing education. However, little is known regarding the effects of mobile application-mediated training on nursing. The aim of this study was to determine the effectiveness of mobile applications by comparing the effectiveness of a high-fidelity human patient simulator to that of a mobile application on student learning. Following lectures on the lungs and the heart, twenty-two students were separated into two groups to perform a simulation exercise. Then, the students' education effects were evaluated based on their knowledge of lung and heart assessments, their clinical assessment skill, and satisfaction with their education. After four weeks, the mobile application group maintained their knowledge, whereas the high-fidelity human patient simulator group exhibited significantly decreased knowledge of the lung assessment. Knowledge of the heart assessment was significantly increased in both groups. There was no significant difference in clinical assessment skill or educational satisfaction between the groups. We found that mobile applications provide educational tools similarly effective to a high-fidelity human patient simulator to maintain memory and to teach cardiopulmonary assessment skills. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effectiveness of betahistine (48 mg/day) in patients with vestibular vertigo during routine practice: The VIRTUOSO study.

PubMed

Parfenov, Vladimir A; Golyk, Volodymyr A; Matsnev, Eduard I; Morozova, Svetlana V; Melnikov, Oleg A; Antonenko, Ludmila M; Sigaleva, Elena E; Situkho, Maksym I; Asaulenko, Olena I; Popovych, Vasyl I; Zamergrad, Maxim V

2017-01-01

Vestibular vertigo is associated with substantially reduced quality of life. Betahistine is effective in improving vertigo-associated symptoms, with longer treatment periods leading to greater improvements; however, it is not known whether these effects persist after treatment cessation. VIRTUOSO was a prospective, multinational, non-comparative, post-marketing observational programme investigating the effectiveness of betahistine (48 mg/day) and the course of vertigo after the discontinuation of treatment. Patients with vestibular vertigo who were prescribed 48 mg/day betahistine were enrolled in Russia and Ukraine. Treatment duration was up to 2 months, and patients were followed up for 2 months after discontinuation of betahistine. Efficacy endpoints included clinical response (assessed by change in vertigo severity), monthly attack frequency, and physician and patient grading of overall clinical response and improvement of vertigo-associated symptoms. Overall, 309 patients were enrolled and 305 completed the study. Clinical response was rated as good, very good or excellent in 74.1% of patients at end of treatment, with vertigo severity significantly decreased from baseline (p < 0.001). Monthly vertigo attack frequency decreased significantly during the 2 months of treatment (p < 0.001 from baseline) and further decreased during the 2-month follow-up (p < 0.001 from end of treatment). Overall, clinical response was graded as good or excellent by 94.4% of physicians and 95.4% of patients. Clinical improvement was considered either good or excellent by 82.6-90.5% of physicians and patients for nausea, vomiting and faintness. Only one adverse event was reported, with no serious adverse events. Our findings suggest that betahistine (48 mg/day) therapy is effective in treating vertigo in routine clinical settings. The observed effects persisted for 2 months after treatment cessation, suggesting that betahistine may facilitate lasting vestibular compensation.

Retention of Knowledge in Clinical Biochemistry and the Effect of the Keller Plan.

ERIC Educational Resources Information Center

Schwartz, Peter L.

1981-01-01

A controlled trial of teaching clinical biochemistry by the Keller Plan at the University of Otago Medical School is described. The Keller Plan group performed significantly better than the control group on the final examination. (MLW)

Zhen gan xi feng decoction, a traditional chinese herbal formula, for the treatment of essential hypertension: a systematic review of randomized controlled trials.

PubMed

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use.

Effects of a kinesthetic cursive handwriting intervention for grade 4-6 students.

PubMed

Roberts, Gwenyth I; Siever, Jodi E; Mair, Judith A

2010-01-01

We studied whether Grade 4-6 students who participated in a kinesthetic writing intervention improved in legibility, speed, and personal satisfaction with cursive handwriting. Small groups of students with handwriting difficulties were seen weekly for 7 wk using a kinesthetic writing system. A repeated measures design was used to evaluate change in global legibility, individual letter formation, specific features of handwriting, and personal satisfaction. Analysis revealed (1) a significant increase in ratings of global legibility (p <.01; clinically significant improvements in 39% of students); (2) significant improvements in letter formation and legibility features of baseline, closure, and line quality (all p < .05); (3) increased handwriting speed (p < .05; not clinically significant); and (4) significant increase in measures with personal satisfaction of handwriting (p < .01). CONCLUSION. A kinesthetic handwriting intervention may be effective in improving the skills of students with handwriting challenges.

Evaluation of the clinical efficacy of meloxicam in cats with painful locomotor disorders.

PubMed

Lascelles, B D; Henderson, A J; Hackett, I J

2001-12-01

The ability of two non-steroidal anti-inflammatory drugs to modify the clinical manifestations of pain associated with locomotor disease was assessed. Sixty-nine cats with acute or chronic locomotor disorders were recruited from 14 first opinion UK veterinary practices and randomly allocated to one of two treatment groups. Group A received meloxicam drops (0.3 mg/kg orally on day 1 followed by 0.1 mg/kg daily for four more consecutive days) and group B received ketoprofen tablets (1.0 mg/kg orally once daily for five days). Each cat underwent a full clinical examination before treatment, 24 hours after initiation of treatment and 24 hours after completion of treatment. General clinical parameters (demeanour and feed intake) and specific locomotor parameters (weightbearing, lameness, local inflammation and pain on palpation) were scored using a discontinuous scale scoring system. The two groups did not differ in terms of age, weight, gender distribution or duration of clinical signs; nor did they differ in terms of general clinical or specific locomotor scores pretreatment. Both treatment regimens resulted in a significant improvement in demeanour, feed intake and weightbearing, and a significant reduction in lameness, pain on palpation and inflammation. No significant difference was observed between the two treatment groups with respect to any of the parameters measured and both treatments were associated with minimal observed side effects. Meloxicam and ketoprofen were found to be effective analgesics and well tolerated in cats with acute or chronic locomotor disorders when administered for short-term treatment (five days) in such cases. However, meloxicam was assessed to be significantly more palatable than ketoprofen.

The analgesic effects of exogenous melatonin in humans.

PubMed

Andersen, Lars Peter Holst

2016-10-01

The hormone, melatonin is produced with circadian rhythm by the pineal gland in humans. The melatonin rhythm provides an endogenous synchronizer, modulating e.g. blood pressure, body temperature, cortisol rhythm, sleep-awake-cycle, immune function and anti-oxidative defence. Interestingly, a number of experimental animal studies demonstrate significant dose-dependent anti-nociceptive effects of exogenous melatonin. Similarly, recent experimental- and clinical studies in humans indicate significant analgesic effects. In study I, we systematically reviewed all randomized studies investigating clinical effects of perioperative melatonin. Meta-analyses demonstrated significant analgesic and anxiolytic effects of melatonin in surgical patients, equating reductions of 20 mm and 19 mm, respectively on a VAS, compared with placebo. Profound heterogeneity between the included studies was, however, present. In study II, we aimed to investigate the analgesic, anti-hyperalgesic and anti-inflammatory effects of exogenous melatonin in a validated human inflammatory pain model, the human burn model. The study was performed as a randomized, double blind placebo-controlled crossover study. Primary outcomes were pain during the burn injury and areas of secondary hyperalgesia. No significant effects of exogenous melatonin were observed with respect to primary or secondary outcomes, compared to placebo. Study III and IV estimated the pharmacokinetic variables of exogenous melatonin. Oral melatonin demonstrated a t max value of 41 minutes. Bioavailability of oral melatonin was only 3%. Elimination t 1/2 were approximately 45 minutes following both oral and intravenous administration, respectively. High-dose intravenous melatonin was not associated with increased sedation, in terms of simple reaction times, compared to placebo. Similarly, no other adverse effects were reported. In Study V, we aimed to re-analyse data obtained from a randomized analgesic drug trial by a selection of standard statistical test. Furthermore, we presented an integrated assessment method of longitudinally measured pain intensity and opioid consumption. Our analyses documented that the employed statistical method impacted the statistical significance of post-operative analgesic outcomes. Furthermore, the novel integrated assessment method combines two interdependent outcomes, lowers the risk of type 2 errors, increases the statistical power, and provides a more accurate description of post-operative analgesic efficacy. Exogenous melatonin may offer an effective and safe analgesic drug. At this moment, however, the results of human studies have been contradictory. High-quality randomized experimental- and clinical studies are still needed to establish a "genuine" analgesic effect of the drug in humans. Other perioperative effects of exogenous melatonin should also be investigated, before melatonin can be introduced for clinical routine use in surgical patients. Despite promising experimental and clinical findings, several unanswered questions also relate to optimal dosage, timing of administration and administration route of exogenous melatonin.

Clinical effectiveness and safety of vildagliptin in >19 000 patients with type 2 diabetes: the GUARD study.

PubMed

Rosales, R; Abou Jaoude, E; Al-Arouj, M; Fawwad, A; Orabi, A; Shah, P; DiTommaso, S; Vaz, J; Latif, Z A

2015-06-01

The present GUARD study was a prospective, non-interventional study evaluating the clinical effectiveness, safety and tolerability of vildagliptin with or without metformin in adult patients with type 2 diabetes mellitus (T2DM) studied in routine clinical practice. Patients were enrolled from countries across four geographical regions. The primary endpoint was change in glycated haemoglobin (HbA1c) concentration from baseline after 24 weeks of treatment with vildagliptin with or without metformin. Of 19 331 patients analysed, 3511 received vildagliptin and 15 820 received vildagliptin plus metformin. At week 24, the mean HbA1c was reduced significantly from baseline by -1.27% (vildagliptin: -1.17%; vildagliptin plus metformin: -1.29%; p < 0.0001). Significant reductions in HbA1c from baseline were consistently reported regardless of patient age, body mass index (BMI) or baseline HbA1c. Weight and BMI were also significantly reduced from baseline. Vildagliptin treatment with or without metformin was generally well tolerated. It provided clinically relevant glycaemic and weight control, and was well tolerated in a large multi-ethnic population of patients with T2DM studied in routine clinical practice. © 2015 John Wiley & Sons Ltd.

Comparison of high glucose concentration blood and crystalloid cardioplegia in paediatric cardiac surgery: a randomized clinical trial

PubMed Central

Mimic, Branko; Ilic, Slobodan; Vulicevic, Irena; Milovanovic, Vladimir; Tomic, Danijela; Mimic, Ana; Stankovic, Sanja; Zecevic, Tatjana; Davies, Ben; Djordjevic, Miroslav

2016-01-01

OBJECTIVES This study investigates the effects of high glucose content on patients undergoing cold crystalloid versus cold blood cardioplegia in terms of early clinical results, functional myocardial recovery and ischaemia–reperfusion injury in patients undergoing repair of acyanotic cardiac lesions. METHODS Patients were randomly assigned to receive either crystalloid (n = 31) or blood cardioplegia (n = 31). Early clinical results were assessed. Changes in left ventricular fractional shortening, arterial blood lactate levels, central venous saturation, cardiac Troponin I release and blood glucose concentration were measured during the first 24 h after ischaemia. RESULTS There was no significant difference in clinical outcomes and postoperative complication rates between groups. The postoperative changes in left ventricular function, lactate levels, central venous saturation and Troponin I were not significantly different between groups. The use of crystalloid cardioplegia was associated with significant increases in serum glucose compared with blood cardioplegia. CONCLUSIONS A high glucose content blood cardioplegia does not show any advantage compared with crystalloid cardioplegia in terms of clinical outcomes, functional recovery and the degree of ischaemic injury in infants and children undergoing repair of acyanotic heart lesions. High glucose concentration of the cardioplegic solution might potentiate ischaemia–reperfusion injury and diminish the beneficial effects of blood cardioplegia. PMID:26831677

A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

PubMed

Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

2016-01-01

The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p<0.01). However, no significant differences were found between the 2 groups regarding American Orthopaedic Foot and Ankle Society's clinical rating system, Painful Foot Evaluation scale of Maryland University scores, or radiologic evaluation (p>0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (p<0.05) and significantly more shortening at the first metatarsal (p<0.05). In moderate hallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

Statistical evaluation of surrogate endpoints with examples from cancer clinical trials.

PubMed

Buyse, Marc; Molenberghs, Geert; Paoletti, Xavier; Oba, Koji; Alonso, Ariel; Van der Elst, Wim; Burzykowski, Tomasz

2016-01-01

A surrogate endpoint is intended to replace a clinical endpoint for the evaluation of new treatments when it can be measured more cheaply, more conveniently, more frequently, or earlier than that clinical endpoint. A surrogate endpoint is expected to predict clinical benefit, harm, or lack of these. Besides the biological plausibility of a surrogate, a quantitative assessment of the strength of evidence for surrogacy requires the demonstration of the prognostic value of the surrogate for the clinical outcome, and evidence that treatment effects on the surrogate reliably predict treatment effects on the clinical outcome. We focus on these two conditions, and outline the statistical approaches that have been proposed to assess the extent to which these conditions are fulfilled. When data are available from a single trial, one can assess the "individual level association" between the surrogate and the true endpoint. When data are available from several trials, one can additionally assess the "trial level association" between the treatment effect on the surrogate and the treatment effect on the true endpoint. In the latter case, the "surrogate threshold effect" can be estimated as the minimum effect on the surrogate endpoint that predicts a statistically significant effect on the clinical endpoint. All these concepts are discussed in the context of randomized clinical trials in oncology, and illustrated with two meta-analyses in gastric cancer. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Beyond Readability: Investigating Coherence of Clinical Text for Consumers

PubMed Central

Hetzel, Scott; Dalrymple, Prudence; Keselman, Alla

2011-01-01

Background A basic tenet of consumer health informatics is that understandable health resources empower the public. Text comprehension holds great promise for helping to characterize consumer problems in understanding health texts. The need for efficient ways to assess consumer-oriented health texts and the availability of computationally supported tools led us to explore the effect of various text characteristics on readers’ understanding of health texts, as well as to develop novel approaches to assessing these characteristics. Objective The goal of this study was to compare the impact of two different approaches to enhancing readability, and three interventions, on individuals’ comprehension of short, complex passages of health text. Methods Participants were 80 university staff, faculty, or students. Each participant was asked to “retell” the content of two health texts: one a clinical trial in the domain of diabetes mellitus, and the other typical Visit Notes. These texts were transformed for the intervention arms of the study. Two interventions provided terminology support via (1) standard dictionary or (2) contextualized vocabulary definitions. The third intervention provided coherence improvement. We assessed participants’ comprehension of the clinical texts through propositional analysis, an open-ended questionnaire, and analysis of the number of errors made. Results For the clinical trial text, the effect of text condition was not significant in any of the comparisons, suggesting no differences in recall, despite the varying levels of support (P = .84). For the Visit Note, however, the difference in the median total propositions recalled between the Coherent and the (Original + Dictionary) conditions was significant (P = .04). This suggests that participants in the Coherent condition recalled more of the original Visit Notes content than did participants in the Original and the Dictionary conditions combined. However, no difference was seen between (Original + Dictionary) and Vocabulary (P = .36) nor Coherent and Vocabulary (P = .62). No statistically significant effect of any document transformation was found either in the open-ended questionnaire (clinical trial: P = .86, Visit Note: P = .20) or in the error rate (clinical trial: P = .47, Visit Note: P = .25). However, post hoc power analysis suggested that increasing the sample size by approximately 6 participants per condition would result in a significant difference for the Visit Note, but not for the clinical trial text. Conclusions Statistically, the results of this study attest that improving coherence has a small effect on consumer comprehension of clinical text, but the task is extremely labor intensive and not scalable. Further research is needed using texts from more diverse clinical domains and more heterogeneous participants, including actual patients. Since comprehensibility of clinical text appears difficult to automate, informatics support tools may most productively support the health care professionals tasked with making clinical information understandable to patients. PMID:22138127

The differences in the assessments of side effects at an oncology outpatient clinic.

PubMed

Bayraktar-Ekincioglu, A; Kucuk, E

2018-04-01

Background There is a growing interest in the use of targeted and immunotherapies in oncology. However, the assessment of side effects can be different due to interpretation of patients' health status by healthcare professionals in oncology outpatient clinics. Objective To demonstrate the differences in the assessments of side effects conducted independently by a clinical pharmacist and nurses in patients who receive targeted therapies at an oncology outpatient clinic. Setting The study was conducted at the University Oncology Hospital in an outpatient clinic from October 2015 to March 2016. Method Patients receiving ipilimumab, nivolumab, pembrolizumab, bevacizumab, panitumumab or cetuximab during study period were included. The assessment of side effects was conducted by a pharmacist and nurse independently using the NCI-CTCAE version-2. Main outcome measure To compare the severity assessments of side effects between a clinical pharmacist and nurses in an outpatient clinic. Results During the study, 204 visits for 43 patients with a total of 5508 side effect assessments were recorded where 1137 (20.64%) assessments were graded differently. Out of 1137 assessments, 473 of them were graded higher by a clinical pharmacist whereas 664 were graded higher by nurses. Statistically significant differences were detected in the assessment of vomiting, taste changes, sense changes, alopecia, fatigue, mood changes, anxiety, hearing impairment, and allergic reactions. Conclusion An assessment of side effects by healthcare providers in patients with cancer may be challenging due to an increased workload in clinics and undistinguishable symptoms of side effects and cancer itself. Therefore, a new care model which increases an interprofessional communication may improve pharmaceutical care in oncology outpatient clinics.

The effects of acupuncture on rates of clinical pregnancy among women undergoing in vitro fertilization: a systematic review and meta-analysis

PubMed Central

Manheimer, Eric; van der Windt, Daniëlle; Cheng, Ke; Stafford, Kristen; Liu, Jianping; Tierney, Jayne; Lao, Lixing; Berman, Brian M.; Langenberg, Patricia; Bouter, Lex M.

2013-01-01

BACKGROUND Recent systematic reviews of adjuvant acupuncture for IVF have pooled heterogeneous trials, without examining variables that might explain the heterogeneity. The aims of our meta-analysis were to quantify the overall pooled effects of adjuvant acupuncture on IVF clinical pregnancy success rates, and evaluate whether study design-, treatment- and population-related factors influence effect estimates. METHODS We included randomized controlled trials that compared needle acupuncture administered within 1 day of embryo transfer, versus sham acupuncture or no adjuvant treatment. Our primary outcome was clinical pregnancy rates. We obtained from all investigators additional methodological details and outcome data not included in their original publications. We analysed sham-controlled and no adjuvant treatment-controlled trials separately, but since there were no large or significant differences between these two subsets, we pooled all trials for subgroup analyses. We prespecified 11 subgroup variables (5 clinical and 6 methodological) to investigate sources of heterogeneity, using single covariate meta-regressions. RESULTS Sixteen trials (4021 participants) were included in the meta-analyses. There was no statistically significant difference between acupuncture and controls when combining all trials [risk ratio (RR) 1.12, 95% confidence interval (CI), 0.96–1.31; I2 = 68%; 16 trials; 4021 participants], or when restricting to sham-controlled (RR 1.02, 0.83–1.26; I2 = 66%; 7 trials; 2044 participants) or no adjuvant treatment-controlled trials (RR 1.22, 0.97–1.52; I2 = 67%; 9 trials; 1977 participants). The type of control used did not significantly explain the statistical heterogeneity (interaction P = 0.27). Baseline pregnancy rate, measured as the observed rate of clinical pregnancy in the control group of each trial, was a statistically significant effect modifier (interaction P < 0.001), and this covariate explained most of the heterogeneity of the effects of adjuvant acupuncture across all trials (adjusted R2 = 93%; I2 residual = 9%). Trials with lower control group rates of clinical pregnancy showed larger effects of adjuvant acupuncture (RR 1.53, 1.28–1.84; 7 trials; 1732 participants) than trials with higher control group rates of clinical pregnancy (RR 0.90, 0.80–1.01; 9 trials; 2289 participants). The asymmetric funnel plot showed a tendency for the intervention effects to be more beneficial in smaller trials. CONCLUSIONS We found no pooled benefit of adjuvant acupuncture for IVF. The subgroup finding of a benefit in trials with lower, but not higher, baseline pregnancy rates (the only statistically significant subgroup finding in our earlier review) has been confirmed in this update, and was not explained by any confounding variables evaluated. However, this baseline pregnancy rate subgroup finding among published trials requires further confirmation and exploration in additional studies because of the multiple subgroup tests conducted, the risk of unidentified confounders, the multiple different factors that determine baseline rates, and the possibility of publication bias. PMID:23814102

Dairy products, satiety and food intake: A meta-analysis of clinical trials.

PubMed

Onvani, Shokouh; Haghighatdoost, Fahimeh; Surkan, Pamela J; Azadbakht, Leila

2017-04-01

Research on how dairy products affect appetite has shown conflicting results. To conduct a meta-analysis of clinical trials to assess the effects of dairy products consumption on satiety and its components (appetite, hunger, prospective food consumption, fullness, desire to eat and second meal food intake). We used PubMed, ISI Web of Science and Google Scholar to search for eligible clinical trials published before February 2015. From over 3000 articles, 13 clinical trials met the inclusion criteria. Analyses were performed to evaluate the effect of dairy consumption on energy intake in a second meal and to study sources of heterogeneity. We also assessed the effects of dairy consumption and subjective indicators of satiety. Primary analyses indicated that dairy consumption decreased energy intake in a second meal but that there was significant heterogeneity (Cochrane Q test, P < 0.001, I 2  = 88.2%). Heterogeneity was eliminated through subgroup analyses based on the type of preload consumed by the control group. All subgroups showed significant decreases in energy intake after consumption of preloads except for fruit drinks, cola, and chocolate bars. Consumption of more than 500 ml of dairy products influenced fullness, hunger, and PFC. Although not statistically significant, dairy consumption was associated with decreased appetite (-3.97, 95%CI: -9.37, 1.43) and desire to eat (-0.11, 95%CI: -4.21, 3.98). However, dairy product consumption significantly increased satiety (7.94, 95%CI: 0.60, 15.28). Consumption of over 500 ml of dairy products can increase satiety and its components. Moreover, the nature of the preload consumed by the control group influenced the effects of increased satiety on decreases in food intake during a second meal. Consumption of dairy products also increased the risk of inducing positive energy balance. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Targeting intensive versus conventional glycaemic control for type 1 diabetes mellitus: a systematic review with meta-analyses and trial sequential analyses of randomised clinical trials

PubMed Central

Kähler, Pernille; Grevstad, Berit; Almdal, Thomas; Gluud, Christian; Wetterslev, Jørn; Vaag, Allan; Hemmingsen, Bianca

2014-01-01

Objective To assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus. Design A systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. Data sources The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded and LILACS to January 2013. Study selection Randomised clinical trials that prespecified different targets of glycaemic control in participants at any age with type 1 diabetes mellitus were included. Data extraction Two authors independently assessed studies for inclusion and extracted data. Results 18 randomised clinical trials included 2254 participants with type 1 diabetes mellitus. All trials had high risk of bias. There was no statistically significant effect of targeting intensive glycaemic control on all-cause mortality (risk ratio 1.16, 95% CI 0.65 to 2.08) or cardiovascular mortality (0.49, 0.19 to 1.24). Targeting intensive glycaemic control reduced the relative risks for the composite macrovascular outcome (0.63, 0.41 to 0.96; p=0.03), and nephropathy (0.37, 0.27 to 0.50; p<0.00001. The effect estimates of retinopathy, ketoacidosis and retinal photocoagulation were not consistently statistically significant between random and fixed effects models. The risk of severe hypoglycaemia was significantly increased with intensive glycaemic targets (1.40, 1.01 to 1.94). Trial sequential analyses showed that the amount of data needed to demonstrate a relative risk reduction of 10% were, in general, inadequate. Conclusions There was no significant effect towards improved all-cause mortality when targeting intensive glycaemic control compared with conventional glycaemic control. However, there may be beneficial effects of targeting intensive glycaemic control on the composite macrovascular outcome and on nephropathy, and detrimental effects on severe hypoglycaemia. Notably, the data for retinopathy and ketoacidosis were inconsistent. There was a severe lack of reporting on patient relevant outcomes, and all trials had poor bias control. PMID:25138801

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

The effect of a combination therapy with myo-inositol and a combined oral contraceptive pill versus a combined oral contraceptive pill alone on metabolic, endocrine, and clinical parameters in polycystic ovary syndrome.

PubMed

Minozzi, Massimo; Costantino, Demetrio; Guaraldi, Claudia; Unfer, Vittorio

2011-11-01

Compare the effects of a combined contraceptive pill (OCP) in combination with myo-inositol (MI) on endocrine, metabolic, and clinical parameters in patients with polycystic ovary syndrome (PCOS). One hundred fifty-five patients with PCOS were enrolled in this prospective, open-label clinical study. Patients were assigned to receive oral treatment with OCP alone (estradiol (EE) 30 μg/gestodene 75 μg) or in combination with myo-inositol 4 g/die, for 12 months. OCP plus MI therapy resulted in a higher reduction of FG score compared with OCP alone therapy. The combined therapy (OCP plus MI) significantly decreased hyperinsulinaemia, by positively affecting the fasting insulin and glucose levels and homeostasis model assessment-insulin resistance parameters, while no significant changes were observed in the OCP group. Androgens serum levels decreased in both groups, but significantly more in the combined therapy group. The lipid profile was improved in the combined therapy group, by reducing low-density lipoprotein cholesterol levels and enhancing high-density lipoprotein cholesterol levels. Our data show that a combination of combined contraceptive pill and MI may be more effective in controlling endocrine, metabolic, and clinical profile in patients with PCOS than OCP alone, and may reduce insulin levels and insulin resistance. Hence, combined treatment may become a more effective long-term therapeutic choice for controlling PCOS symptoms.

Cost-effectiveness analysis of a new 8% capsaicin patch compared to existing therapies for postherpetic neuralgia.

PubMed

Armstrong, Edward P; Malone, Daniel C; McCarberg, Bill; Panarites, Christopher J; Pham, Sissi V

2011-05-01

The purpose of this study was to compare the cost effectiveness of a new 8% capsaicin patch, compared to the current treatments for postherpetic neuralgia (PHN), including tricyclic antidepressants (TCAs), topical lidocaine patches, duloxetine, gabapentin, and pregabalin. A 1-year Markov model was constructed for PHN with monthly cycles, including dose titration and management of adverse events. The perspective of the analysis was from a payer perspective, managed-care organization. Clinical trials were used to determine the proportion of patients achieving at least a 30% improvement in PHN pain, the efficacy parameter. The outcome was cost per quality-adjusted life-year (QALY); second-order probabilistic sensitivity analyses were conducted. The effectiveness results indicated that 8% capsaicin patch and topical lidocaine patch were significantly more effective than the oral PHN products. TCAs were least costly and significantly less costly than duloxetine, pregabalin, topical lidocaine patch, 8% capsaicin patch, but not gabapentin. The incremental cost-effectiveness ratio for the 8% capsaicin patch overlapped with the topical lidocaine patch and was within the accepted threshold of cost per QALY gained compared to TCAs, duloxetine, gabapentin, and pregablin. The frequency of the 8% capsaicin patch retreatment assumption significantly impacts its cost-effectiveness results. There are several limitations to this analysis. Since no head-to-head studies were identified, this model used inputs from multiple clinical trials. Also, a last observation carried forward process was assumed to have continued for the duration of the model. Additionally, the trials with duloxetine may have over-predicted its efficacy in PHN. Although a 30% improvement in pain is often an endpoint in clinical trials, some patients may require greater or less improvement in pain to be considered a clinical success. The effectiveness results demonstrated that 8% capsaicin and topical lidocaine patches had significantly higher effectiveness rates than the oral agents used to treat PHN. In addition, this cost-effectiveness analysis found that the 8% capsaicin patch was similar to topical lidocaine patch and within an accepted cost per QALY gained threshold compared to the oral products.

Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain.

PubMed

van Tilburg, C W J; Stronks, D L; Groeneweg, J G; Huygen, F J P M

2017-03-01

Investigate the effect of percutaneous radiofrequency compared to a sham procedure, applied to the ramus communicans for treatment of lumbar disc pain. Randomized sham-controlled, double-blind, crossover, multicenter clinical trial. Multidisciplinary pain centres of two general hospitals. Sixty patients aged 18 or more with medical history and physical examination suggestive for lumbar disc pain and a reduction of two or more on a numerical rating scale (0-10) after a diagnostic ramus communicans test block. Treatment group: percutaneous radiofrequency treatment applied to the ramus communicans; sham: same procedure except radiofrequency treatment. pain reduction. Secondary outcome measure: Global Perceived Effect. No statistically significant difference in pain level over time between the groups, as well as in the group was found; however, the factor period yielded a statistically significant result. In the crossover group, 11 out of 16 patients experienced a reduction in NRS of 2 or more at 1 month (no significant deviation from chance). No statistically significant difference in satisfaction over time between the groups was found. The independent factors group and period also showed no statistically significant effects. The same applies to recovery: no statistically significant effects were found. The null hypothesis of no difference in pain reduction and in Global Perceived Effect between the treatment and sham group cannot be rejected. Post hoc analysis revealed that none of the investigated parameters contributed to the prediction of a significant pain reduction. Interrupting signalling through the ramus communicans may interfere with the transition of painful information from the discs to the central nervous system. Methodological differences exist in studies evaluating the efficacy of radiofrequency treatment for lumbar disc pain. A randomized, sham-controlled, double-blind, multicenter clinical trial on the effect of radiofrequency at the ramus communicans for lumbar disc pain was conducted. The null hypothesis of no difference in pain reduction and in Global Perceived Effect between the treatment and sham group cannot be rejected. © 2016 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC®.

Students' self-explanations while solving unfamiliar cases: the role of biomedical knowledge.

PubMed

Chamberland, Martine; Mamede, Sílvia; St-Onge, Christina; Rivard, Marc-Antoine; Setrakian, Jean; Lévesque, Annie; Lanthier, Luc; Schmidt, Henk G; Rikers, Remy M J P

2013-11-01

General guidelines for teaching clinical reasoning have received much attention, despite a paucity of instructional approaches with demonstrated effectiveness. As suggested in a recent experimental study, self-explanation while solving clinical cases may be an effective strategy to foster reasoning in clinical clerks dealing with less familiar cases. However, the mechanisms that mediate this benefit have not been specifically investigated. The aim of this study was to explore the types of knowledge used by students when solving familiar and less familiar clinical cases with self-explanation. In a previous study, 36 third-year medical students diagnosed familiar and less familiar clinical cases either by engaging in self-explanation or not. Based on an analysis of previously collected data, the present study compared the content of self-explanation protocols generated by seven randomly selected students while solving four familiar and four less familiar cases. In total, 56 verbal protocols (28 familiar and 28 less familiar) were segmented and coded using the following categories: paraphrases, biomedical inferences, clinical inferences, monitoring statements and errors. Students provided more self-explanation segments from less familiar cases (M = 275.29) than from familiar cases (M = 248.71, p = 0.046). They provided significantly more paraphrases (p = 0.001) and made more errors (p = 0.008). A significant interaction was found between familiarity and the type of inferences (biomedical versus clinical, p = 0.016). When self-explaining less familiar cases, students provided significantly more biomedical inferences than familiar cases. Lack of familiarity with a case seems to stimulate medical students to engage in more extensive thinking during self-explanation. Less familiar cases seem to activate students' biomedical knowledge, which in turn helps them to create new links between biomedical and clinical knowledge, and eventually construct a more coherent mental representation of diseases. This may clarify the previously found positive effect that self-explanation has on the diagnosis of unfamiliar cases. © 2013 John Wiley & Sons Ltd.

Cost-effectiveness of prize-based incentives for stimulant abusers in outpatient psychosocial treatment programs.

PubMed

Olmstead, Todd A; Sindelar, Jody L; Petry, Nancy M

2007-03-16

To evaluate the cost-effectiveness of a prize-based intervention as an addition to usual care for stimulant abusers. This cost-effectiveness analysis is based on a randomized clinical trial implemented within the National Drug Abuse Treatment Clinical Trials Network. The trial was conducted at eight community-based outpatient psychosocial drug abuse treatment clinics. Four hundred and fifteen stimulant abusers were assigned to usual care (N=206) or usual care plus abstinence-based incentives (N=209) for 12 weeks. Participants randomized to the incentive condition earned the chance to draw for prizes for submitting substance negative samples; the number of draws earned increased with continuous abstinence time. Incremental cost-effectiveness ratios were estimated to compare prize-based incentives relative to usual care. The primary patient outcome was longest duration of confirmed stimulant abstinence (LDA). Unit costs were obtained via surveys administered at the eight participating clinics. Resource utilizations and patient outcomes were obtained from the clinical trial. Acceptability curves are presented to illustrate the uncertainty due to the sample and to provide policy relevant information. The incremental cost to lengthen the LDA by 1 week was 258 US dollars (95% confidence interval, 191-401 US dollars). Sensitivity analyses on several key parameters show that this value ranges from 163 to 269 US dollars. Compared with the usual care group, the incentive group had significantly longer LDAs and significantly higher costs.

[Clinical effect of Saccharomyces boulardii powder combined with azithromycin sequential therapy in treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia].

PubMed

Chen, Qi-Fen; Zhang, Yi-Wei

2018-02-01

To investigate the clinical effect of Saccharomyces boulardii powder combined with azithromycin sequential therapy in the treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia. A total of 88 children with diarrhea secondary to Mycoplasma pneumoniae pneumonia between June 2015 and March 2017 were divided into control group and study group using a random number table, with 44 children in each group. The children in the control group were given routine treatment combined with azithromycin sequential therapy, and those in the study group were given oral Saccharomyces boulardii powder in addition to the treatment in the control group until the end of azithromycin sequential therapy. After the treatment ended, the two groups were compared in terms of time to improvement of clinical symptoms, length of hospital stay, clinical outcome, defecation frequency before and after treatment, condition of intestinal dysbacteriosis, and incidence of adverse events. Compared with the control group, the study group had significantly shorter time to improvement of clinical symptoms and length of hospital stay (P<0.05). The study group had a significantly higher response rate than the control group (P<0.05). On days 3 and 5 of treatment, the study group had a significant reduction in defecation frequency compared with the control group (P<0.05). The study group had a significantly lower rate of intestinal dysbacteriosis than the control group (P<0.05). There was no significant difference in the incidence of adverse events between the two groups (P>0.05). In the treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia, Saccharomyces boulardii powder combined with azithromycin sequential therapy can improve clinical symptoms, shorten the length of hospital stay, reduce defecation frequency and the incidence of intestinal dysbacteriosis, and improve clinical outcomes, and does not increase the risk of adverse events.

Comparison of Technical and Clinical Outcome of Transjugular Portosystemic Shunt Placement Between a Bare Metal Stent and a PTFE-Stentgraft Device.

PubMed

Lauermann, J; Potthoff, A; Mc Cavert, M; Marquardt, S; Vaske, B; Rosenthal, H; von Hahn, T; Wacker, F; Meyer, B C; Rodt, Thomas

2016-04-01

To analyse technical and clinical success of transjugular intrahepatic portosystemic shunt (TIPS) in patients with portal hypertension and compare a stent and a stentgraft with regard to clinical and technical outcome and associated costs. 170 patients (56 ± 12 years, 32.9% females) treated with TIPS due to portal hypertension were reviewed. 80 patients received a stent (group 1) and 83 a stentgraft (group 2), and seven interventions were unsuccessful. Technical data, periprocedural imaging, follow-up ultrasound and clinical data were analysed with focus on technical success, patency, clinical outcome and group differences. Cost analysis was performed. Portal hypertension was mainly caused by ethyltoxic liver cirrhosis with ascites as dominant symptom (80%). Technical success was 93.5% with mean portosystemic gradient decrease from 16.1 ± 4.8 to 5.1 ± 2.1 mmHg. No significant differences in technical success and portosystemic gradient decrease between the groups were observed. Kaplan-Meier analysis yielded significant differences in primary patency after 14 days, 6 months and 2 years in favour of the stentgraft. Both groups showed good clinical results without significant difference in 1-year survival and hepatic encephalopathy rate. Costs to establish TIPS and to manage 2-year follow-up with constant patency and clinical success were 8876 € (group 1) and 9394 € (group 2). TIPS is a safe and effective procedure to manage portal hypertension. Stent and stentgraft enabled good technical and clinical results with a low complication rate. Primary patency rates are clearly in favour of the stentgraft, whereas the stent was more cost effective with similar clinical results in both groups.

Comparison of Technical and Clinical Outcome of Transjugular Portosystemic Shunt Placement Between a Bare Metal Stent and a PTFE-Stentgraft Device

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

Lauermann, J., E-mail: jostlauermann@gmail.com; Potthoff, A.; Mc Cavert, M.

PurposeTo analyse technical and clinical success of transjugular intrahepatic portosystemic shunt (TIPS) in patients with portal hypertension and compare a stent and a stentgraft with regard to clinical and technical outcome and associated costs.Materials and Methods170 patients (56 ± 12 years, 32.9 % females) treated with TIPS due to portal hypertension were reviewed. 80 patients received a stent (group 1) and 83 a stentgraft (group 2), and seven interventions were unsuccessful. Technical data, periprocedural imaging, follow-up ultrasound and clinical data were analysed with focus on technical success, patency, clinical outcome and group differences. Cost analysis was performed.ResultsPortal hypertension was mainly caused by ethyltoxicmore » liver cirrhosis with ascites as dominant symptom (80 %). Technical success was 93.5 % with mean portosystemic gradient decrease from 16.1 ± 4.8 to 5.1 ± 2.1 mmHg. No significant differences in technical success and portosystemic gradient decrease between the groups were observed. Kaplan–Meier analysis yielded significant differences in primary patency after 14 days, 6 months and 2 years in favour of the stentgraft. Both groups showed good clinical results without significant difference in 1-year survival and hepatic encephalopathy rate. Costs to establish TIPS and to manage 2-year follow-up with constant patency and clinical success were 8876 € (group 1) and 9394 € (group 2).ConclusionTIPS is a safe and effective procedure to manage portal hypertension. Stent and stentgraft enabled good technical and clinical results with a low complication rate. Primary patency rates are clearly in favour of the stentgraft, whereas the stent was more cost effective with similar clinical results in both groups.« less

The effect of colour and design in labour and delivery: A scientific approach

NASA Astrophysics Data System (ADS)

Duncan, Jane

2011-03-01

This study was part of a broader three year research project at London's Chelsea and Westminster Hospital, "A Study of the Effect of the Visual and Performing Arts in Healthcare", exploring whether visual and performing arts have any measurable effect on physiological, psychological and biological outcomes of clinical significance on patient recovery, and providing a potential cost saving benefit to the NHS. In this specific study of women in labour, two measurements were identified as having clinical significance for achieving optimal outcomes during labour and delivery: length of labour and frequency of requirement for analgesia. A screen was designed to hide emergency equipment with the joint aim of reducing women's anxieties and (through visual art) acting as a focal point of attention and distraction during labour, thus diminishing requirements for analgesia. Results demonstrated, in the presence of the screen, a statistically significant shortening of the duration of labour by 2.1h with frequency of requests for epidural analgesia 7% lower in the study group than in the control group. The significant clinical outcomes of this research provide the evidence of the value of integrating visual art into the environment of a labour and delivery room, improving the quality of the maternity service and potentially delivering real cost savings benefits to Hospitals.

Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study).

PubMed

Suh, Sunghwan; Song, Sun Ok; Kim, Jae Hyeon; Cho, Hyungjin; Lee, Woo Je; Lee, Byung-Wan

2017-01-01

The present observational study aimed to evaluate the clinical effectiveness of vildagliptin with metformin in Korean patients with type 2 diabetes mellitus (T2DM). Data were pooled from the vildagliptin postmarketing survey (PMS), the vildagliptin/metformin fixed drug combination (DC) PMS, and a retrospective observational study of vildagliptin/metformin (fixed DC or free DC). The effectiveness endpoint was the proportion of patients who achieved a glycemic target (HbA1c) of ≤7.0% at 24 weeks. In total, 4303 patients were included in the analysis; of these, 2087 patients were eligible. The mean patient age was 56.99 ± 11.25 years. Overall, 58.94% patients achieved an HbA1c target of ≤7.0% at 24 weeks. The glycemic target achievement rate was significantly greater in patients with baseline HbA1c < 7.5% versus ≥7.5% (84.64% versus 43.97%), receiving care at the hospital versus clinic (67.95% versus 52.33%), and receiving vildagliptin/metformin fixed DC versus free DC (70.69% versus 55.42%). Multivariate logistic regression analysis indicated that disease duration ( P < 0.0001), baseline HbA1c ( P < 0.0001), and DC type ( P = 0.0103) had significant effects on drug effectiveness. Vildagliptin plus metformin appeared as an effective treatment option for patients with T2DM in clinical practice settings in Korea.

A clinically meaningful training effect in walking speed using functional electrical stimulation for motor-incomplete spinal cord injury.

PubMed

Street, Tamsyn; Singleton, Christine

2018-05-01

The study aimed to investigate the presence of a training effect for rehabilitation of walking function in motor-incomplete spinal cord injury (SCI) through daily use of functional electrical stimulation (FES). A specialist FES outpatient centre. Thirty-five participants (mean age 53, SD 15, range 18-80; mean years since diagnosis 9, range 5 months - 39 years) with drop foot and motor-incomplete SCI (T12 or higher, ASIA Impairment Scale C and D) able to ambulate 10 metres with the use of a walking stick or frame. FES of the peroneal nerve, glutei and hamstrings as clinically indicated over six months in the community. The data was analysed for a training effect (difference between unassisted ten metre walking speed at baseline and after six months) and orthotic effects (difference between walking speed with and without FES) initially on day one and after six months. The data was further analysed for a minimum clinically important difference (MCID) (>0.06 m/s). A clinically meaningful, significant change was observed for initial orthotic effect (0.13m/s, CI: 0.04-0.17, P = 0.013), total orthotic effect (0.11m/s, CI: 0.04-0.18, P = 0.017) and training effect (0.09m/s, CI: 0.02-0.16, P = 0.025). The results suggest that daily independent use of FES may produce clinically meaningful changes in walking speed which are significant for motor-incomplete SCI. Further research exploring the mechanism for the presence of a training effect may be beneficial in targeting therapies for future rehabilitation.

Birth order and sibling sex ratio of children and adolescents referred to a gender identity service.

PubMed

Vanderlaan, Doug P; Blanchard, Ray; Wood, Hayley; Zucker, Kenneth J

2014-01-01

In adult male samples, homosexuality is associated with a preponderance of older brothers (i.e., the fraternal birth order effect). In several studies comparing gender dysphoric youth, who are likely to be homosexual in adulthood, to clinical or non-clinical control groups, the findings have been consistent with the fraternal birth order effect in males; however, less is known about unique sibship characteristics of gender dysphoric females. The current study investigated birth order and sibling sex ratio in a large sample of children and adolescents referred to the same Gender Identity Service (N = 768). Probands were classified as heterosexual males, homosexual males, or homosexual females based on clinical diagnostic information. Groups differed significantly in age and sibship size, and homosexual females were significantly more likely to be only children. Subsequent analyses controlled for age and for sibship size. Compared to heterosexual males, homosexual males had a significant preponderance of older brothers and homosexual females had a significant preponderance of older sisters. Similarly, the older sibling sex ratio of homosexual males showed a significant excess of brothers whereas that of homosexual females showed a significant excess of sisters. Like previous studies of gender dysphoric youth and adults, these findings were consistent with the fraternal birth order effect. In addition, the greater frequency of only children and elevated numbers of older sisters among the homosexual female group adds to a small literature on sibship characteristics of potential relevance to the development of gender identity and sexual orientation in females.

Predictors of job satisfaction among Academic Faculty: Do instructional and clinical faculty differ?

PubMed Central

Chung, Kevin C.; Song, Jae W.; Kim, H. Myra; Woolliscroft, James O.; Quint, Elisabeth H.; Lukacs, Nicholas W.; Gyetko, Margaret R.

2010-01-01

Objectives To identify and compare predictors of job satisfaction between the instructional and clinical faculty tracks. Method A 61-item faculty job satisfaction survey was distributed to 1,898 academic faculty at the University of Michigan Medical School. The anonymous survey was web-based. Questions covered topics on departmental organization, research, clinical and teaching support, compensation, mentorship, and promotion. Levels of satisfaction were contrasted between the two tracks, and predictors of job satisfaction were identified using linear regression models. Results The response rates for the instructional and clinical tracks were 43.1% and 41.3%, respectively. Clinical faculty reported being less satisfied with how they are mentored, and fewer reported understanding the process for promotion. There was no significant difference in overall job satisfaction between faculty tracks. Surprisingly, clinical faculty with mentors were significantly less satisfied with how they were being mentored, with career advancement and overall job satisfaction, compared to instructional faculty mentees. Additionally, senior-level clinical faculty were significantly less satisfied with their opportunities to mentor junior faculty compared to senior-level instructional faculty. Significant predictors of job satisfaction for both tracks included areas of autonomy, meeting career expectations, work-life balance, and departmental leadership. Unique to the clinical track, compensation and career advancement variables also emerged as significant predictors. Conclusion Greater effort must be placed in the continued attention to faculty well-being both at the institutional level and at the level of departmental leadership. Success in enhancing job satisfaction is more likely if directed by locally designed assessments involving department chairs, specifically in fostering more effective mentoring relationships focused on making available career advancement activities such as research activities. Our findings show this strategy to significantly impact the job satisfaction and retention of clinical track faculty members. PMID:20880368

Magnesium sulfate micro air pump suction for bronchiolitis treatment in infants under two years old.

PubMed

Kan, R-X; Zhang, C-L; Zhen, Q; Chen, J

2016-01-01

To investigate the efficiency, clinical effects and nursing methods related to the use of magnesium sulfate micro air pump suction for treating infants under two years old suffering from bronchiolitis. From January 2014 to September 2014, ninety-six infants with capillary bronchitis were enrolled. Patients were randomly divided into two groups: experimental group (n=49) and control group (n=47). All patients went through conventional anti-inflammatory therapy. Based on this, infants in the control group were additionally treated with intravenous drip of magnesium sulfate while patients in the experimental group were treated with magnesium sulfate micro air pump suction. We recorded all changes in blood gas and clinical scores, the residence time of symptoms and signs of bronchiolitis, and hospitalization time. Results obtained on clinical effects and adverse reactions were compared and analyzed. The Variations of PaO2, PaCO2, SaO2 before treatment in both groups did not show any statistically significant differences (p>0.05); while after treatment analyses demonstrated that in both groups we had an increase in PaO2 and SaO2 and a decrease in PaCO2. The increase in PaO2 and SaO2 values were more pronounced while the decrease observed in PaCO2 was more significant in our experimental group. The total effective rate was significantly higher while the total adverse reaction rate, the resolution time of clinical symptoms and hospitalization time were significantly lower in our experimental group. Magnesium sulfate micro air pump suction was safe and effective in treating with bronchiolitis of infants below 2 years old, and its adverse reaction rate was low, nursing procedure was simple, and nursing difficulty level was low.

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention Versus Clinic-Based Specialty Care for Veterans.

PubMed

Calhoun, Patrick S; Datta, Santanu; Olsen, Maren; Smith, Valerie A; Moore, Scott D; Hair, Lauren P; Dedert, Eric A; Kirby, Angela; Dennis, Michelle; Beckham, Jean C; Bastian, Lori A

2016-10-01

The primary objective of this project was to examine the effectiveness of an Internet-based smoking cessation intervention combined with a tele-health medication clinic for nicotine replacement therapy (NRT) compared to referral to clinic-based smoking cessation care. A total of 413 patients were proactively recruited from the Durham VA Medical Center and followed for 12 months. Patients were randomized to receive either a referral to VA specialty smoking cessation care (control) or to the Internet intervention and tele-health medication clinic. Primary outcomes included (1) intervention reach, (2) self-reported 7-day point prevalence abstinence rates at 3 months and 12 months, and 3) relative cost-effectiveness. Reach of the Internet intervention and use of smoking cessation aids were significantly greater compared to the control. At 3 months-post randomization, however, there were no significant differences in quit rates: 17% (95% CI: 12%–23%) in the Internet-based intervention compared to 12% (95% CI: 8%–17%) in the control arm. Similarly, there were no differences in quit rates at 12 months (13% vs. 16%). While costs associated with the Internet arm were higher due to increased penetration and intensity of NRT use, there were no statistically significant differences in the relative cost effectiveness (e.g., life years gained, quality adjusted life years) between the two arms. Current results suggest that using an electronic medical record to identify smokers and proactively offering smoking cessation services that are consistent with US Public Health Guidelines can significantly reduce smoking in veterans. Novel interventions that increase the reach of intensive treatment are needed to maximize quit rates in this population.

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention versus Clinic-Based Specialty Care for Veterans

PubMed Central

Calhoun, Patrick S.; Datta, Santanu; Olsen, Maren; Smith, Valerie A.; Moore, Scott D.; Hair, Lauren P.; Dedert, Eric A.; Kirby, Angela; Dennis, Michelle; Beckham, Jean C.; Bastian, Lori A

2016-01-01

Introduction The primary objective of this project was to examine the effectiveness of an internet-based smoking cessation intervention combined with a tele-health medication clinic for nicotine replacement therapy (NRT) compared to referral to clinic-based smoking cessation care. Methods A total of 413 patients were proactively recruited from the Durham VA Medical Center and followed for 12 months. Patients were randomized to receive either a referral to VA specialty smoking cessation care (control) or to the internet intervention and tele-health medication clinic. Primary outcomes included (1) intervention reach, (2) self-reported 7-day point prevalence abstinence rates at 3 months and 12 months, and 3) relative cost-effectiveness. Results Reach of the internet intervention and use of smoking cessation aids were significantly greater compared to the control. At 3 months-post randomization, however, there were no significant differences in quit rates: 17% (95% CI: 12%–23%) in the internet-based intervention compared to 12% (95% CI: 8%–17%) in the control arm. Similarly, there were no differences in quit rates at 12 months (13% vs. 16%). While costs associated with the internet arm were higher due to increased penetration and intensity of NRT use, there were no statistically significant differences in the relative cost effectiveness (e.g., life years gained, quality adjusted life years) between the two arms. Conclusions Current results suggest that using an electronic medical record to identify smokers and proactively offering smoking cessation services that are consistent with US Public Health Guidelines can significantly reduce smoking in veterans. Novel interventions that increase the reach of intensive treatment are needed to maximize quit rates in this population. PMID:27568506

Effect of Mindfulness Training on Asthma Quality of Life and Lung Function: A Randomized Controlled Trial

PubMed Central

Pbert, Lori; Madison, J. Mark; Druker, Susan; Olendzki, Nicholas; Magner, Robert; Reed, George; Carmody, James

2014-01-01

Background Improving asthma patients’ quality of life is an important clinical outcome. This study evaluated the efficacy of mindfulness-based stress reduction (MBSR) in improving quality of life and lung function in patients with asthma. Methods A randomized controlled trial compared an 8 week MBSR group-based program (n = 42) to an educational control program (n = 41) in adults with mild, moderate or severe persistent asthma recruited at a university hospital outpatient primary care and pulmonary care clinic. Primary outcomes were quality of life assessed by the Asthma Quality of Life Questionnaire (AQOL), and lung function assessed by change from baseline in two-week average morning peak expiratory flow (PEF). Secondary outcomes were asthma control assessed by 2007 NIH/NHLBI guidelines, and stress assessed by Perceived Stress Scale. Follow-up assessments were conducted at 10 weeks, 6 and 12 months. Results At 12 months MBSR resulted in clinically significant improvements in quality of life (intervention effect 0.55 (95% CI 0.21, 0.89, p=0.001)) and perceived stress (intervention effect −4.5 (95% CI −7.1, −1.9; p= 0.001)). No significant effect was found on lung function (morning PEF, PEF variability, and FEV1). At 12 months the percentage of patients in MBSR with well-controlled asthma showed a non-statistically significant increase (7.3% at baseline to 19.4%) compared to the control condition (7.5% and 7.9%, respectively) (p=0.30). Conclusions MBSR produced lasting clinically significant improvements in asthma-related quality of life and stress in patients with persistent asthma, even in the absence of improvements in lung function. PMID:22544892

Effects and moderators of psychosocial interventions on quality of life, and emotional and social function in patients with cancer: An individual patient data meta‐analysis of 22 RCTs

PubMed Central

Kalter, J.; Verdonck‐de Leeuw, I.M.; Sweegers, M.G.; Aaronson, N.K.; Jacobsen, P.B.; Newton, R.U.; Courneya, K.S.; Aitken, J.F.; Armes, J.; Arving, C.; Boersma, L.J.; Braamse, A.M.J.; Brandberg, Y.; Chambers, S.K.; Dekker, J.; Ell, K.; Ferguson, R.J.; Gielissen, M.F.M.; Glimelius, B.; Goedendorp, M.M.; Graves, K.D.; Heiney, S.P.; Horne, R.; Hunter, M.S.; Johansson, B.; Kimman, M.L.; Knoop, H.; Meneses, K.; Northouse, L.L.; Oldenburg, H.S.; Prins, J.B.; Savard, J.; van Beurden, M.; van den Berg, S.W.; Brug, J.

2018-01-01

Abstract Objective This individual patient data (IPD) meta‐analysis aimed to evaluate the effects of psychosocial interventions (PSI) on quality of life (QoL), emotional function (EF), and social function (SF) in patients with cancer, and to study moderator effects of demographic, clinical, personal, and intervention‐related characteristics. Methods Relevant studies were identified via literature searches in 4 databases. We pooled IPD from 22 (n = 4217) of 61 eligible randomized controlled trials. Linear mixed‐effect model analyses were used to study intervention effects on the post‐intervention values of QoL, EF, and SF (z‐scores), adjusting for baseline values, age, and cancer type. We studied moderator effects by testing interactions with the intervention for demographic, clinical, personal, and intervention‐related characteristics, and conducted subsequent stratified analyses for significant moderator variables.Results: PSI significantly improved QoL (β = 0.14,95%CI = 0.06;0.21), EF (β = 0.13,95%CI = 0.05;0.20), and SF (β = 0.10,95%CI = 0.03;0.18). Significant differences in effects of different types of PSI were found, with largest effects of psychotherapy. The effects of coping skills training were moderated by age, treatment type, and targeted interventions. Effects of psychotherapy on EF may be moderated by cancer type, but these analyses were based on 2 randomized controlled trials with small sample sizes of some cancer types. Conclusions PSI significantly improved QoL, EF, and SF, with small overall effects. However, the effects differed by several demographic, clinical, personal, and intervention‐related characteristics. Our study highlights the beneficial effects of coping skills training in patients treated with chemotherapy, the importance of targeted interventions, and the need of developing interventions tailored to the specific needs of elderly patients. PMID:29361206

Effect of UV irradiation on cutaneous cicatrices: a randomized, controlled trial with clinical, skin reflectance, histological, immunohistochemical and biochemical evaluations.

PubMed

Due, Eva; Rossen, Kristian; Sorensen, Lars Tue; Kliem, Anette; Karlsmark, Tonny; Haedersdal, Merete

2007-01-01

The aim of this study was to examine the effect of ultraviolet (UV) irradiation on human cutaneous cicatrices. In this randomized, controlled study, dermal punch biopsy wounds served as a wound healing model. Wounds healed by primary or second intention and were randomized to postoperative solar UV irradiation or to no UV exposure. Evaluations after 5 and 12 weeks included blinded clinical assessments, skin reflectance measurements, histology, immunohistochemistry, and biochemical analyses of the N-terminal propeptide from procollagen-1, hydroxyproline, hydroxylysine, and proline. Twelve weeks postoperatively, UV-irradiated cicatrices healing by second intention: (i) were significantly pointed out as the most disfiguring; (ii) obtained significantly higher scores of colour, infiltration and cicatrix area; and (iii) showed significantly higher increase in skin-reflectance measurements of skin-pigmentation vs. non-irradiated cicatrices. No histological, immunohistochemical or biochemical differences were found. In conclusion, postoperative UV exposure aggravates the clinical appearance of cicatrices in humans.

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.

A meta-meta-analysis of the effect of physical activity on depression and anxiety in non-clinical adult populations.

PubMed

Rebar, Amanda L; Stanton, Robert; Geard, David; Short, Camille; Duncan, Mitch J; Vandelanotte, Corneel

2015-01-01

Amidst strong efforts to promote the therapeutic benefits of physical activity for reducing depression and anxiety in clinical populations, little focus has been directed towards the mental health benefits of activity for non-clinical populations. The objective of this meta-meta-analysis was to systematically aggregate and quantify high-quality meta-analytic findings of the effects of physical activity on depression and anxiety for non-clinical populations. A systematic search identified eight meta-analytic outcomes of randomised trials that investigated the effects of physical activity on depression or anxiety. The subsequent meta-meta-analyses were based on a total of 92 studies with 4310 participants for the effect of physical activity on depression and 306 study effects with 10,755 participants for the effect of physical activity on anxiety. Physical activity reduced depression by a medium effect [standardised mean difference (SMD) = -0.50; 95% CI: -0.93 to -0.06] and anxiety by a small effect (SMD = -0.38; 95% CI: -0.66 to -0.11). Neither effect showed significant heterogeneity across meta-analyses. These findings represent a comprehensive body of high-quality evidence that physical activity reduces depression and anxiety in non-clinical populations.

Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

PubMed Central

Pellicoro, C.; Marsella, R.; Ahrens, K.

2013-01-01

This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

The effect of dexamethasone and promethazine in combination with buparvaquone in the management of East Coast fever.

PubMed

Gwamaka, M; Matovelo, J A; Mtambo, M M A; Mbassa, G K; Maselle, R M; Boniphace, S

2004-06-01

The effects of dexamethasone and promethazine on the amelioration of pulmonary oedema in East Coast fever were investigated. The clinical effects of these drugs were further investigated when used in conjunction with the antitheilerial drug, buparvaquone. In the first experiment, 15 crossbred (Friesian x Zebu) steers were divided into four groups. With the exception of the animals in group IV, that served as a control group all the others were infected with Theileria parva sporozoites. On the second day of the febrile reaction, the steers in groups I and II were treated with dexamethasone (0.1 mg/kg) and promethazine (1 mg/kg), respectively. Group III steers served as the infected untreated controls. On the fifth day of the febrile reaction the animals in groups I, II and III were infused intravenously with tattoo ink suspension and 1 h later sacrificed for post-mortem examination and tissue sampling. The clinical picture indicated that both drugs significantly mitigated dyspnoea and the post mortem examination revealed a significant reduction in morphological changes. Tattoo ink particle count reflected a significant (P< 0.01) reduction in vascular leakage in the treated animals, with promethazine being significantly (P < 0.05) more effective than dexamethasone in this respect. In the second experiment, 18 steers were infected with T. parva sporozoites, and then were randomly allotted into three groups each of which contained six animals. After the onset of ECF clinical signs, the animals in the first two groups were treated with buparvaquone in combination with either dexamethasone (group I) or promethazine (group II), and the third group was treated with buparvaquone alone. The results indicated that all the animals in groups I, II and III recovered well and no significant differences were observed in clinical disposition between the groups. Two months later, serum samples were collected from the refractory animals and demonstrated the presence of antibodies against T. parva. When the animals were subsequently artificially challenged with T. parva, none of them succumbed to clinical disease. The same T. parva stabilate stock was used in both experiments and it proved to be infective in a separate batch of steers.

Learning for clinical leadership.

PubMed

Cook, Michael J; Leathard, Helen L

2004-11-01

Clinical leadership has been acclaimed widely as a major factor influencing the quality of patient care but research has revealed a paucity of preparation for this significant role. Leadership literature has rarely addressed clinical leadership specifically or referred to the difficulties in characterizing effective clinical leaders. The research informing this paper focused on clinical leadership and identified five attributes of effective clinical leaders: creativity, highlighting, influencing, respecting, and supporting. Effective clinical leaders adopted a transformational leadership style and improved care, through others, by including transformational (soft) knowledge as an integral part of their effective practice repertoire. Phronesis is introduced as practical wisdom that is gained through immersion in relevant experience, and as an essential element of preparation for clinical nursing leadership practice. It is argued, that learning to transform care requires opportunities to work within an environment that engenders and supports aspiring leaders. The paper describes the research process, elucidates the attributes through illustrative examples from the research data, and discusses an emergent educational strategy for the development of these attributes by clinicians in their practice environments. The paper also describes the application of this research through an interdisciplinary programme for staff leading teams in both health and social services sectors.

Significant Effect of Valproate Augmentation Therapy in Patients With Schizophrenia

PubMed Central

Tseng, Ping-Tao; Chen, Yen-Wen; Chung, Weilun; Tu, Kun-Yu; Wang, Hung-Yu; Wu, Ching-Kuan; Lin, Pao-Yen

2016-01-01

Abstract Valproate is an anticonvulsant, which is also widely used for treating psychiatric disorders. Some clinical trials have demonstrated benefits of valproate augmentation therapy in schizophrenia. Previous meta-analysis showed inconsistent findings because of limited literature at that time. The aim of this study is to update the newer published data by conducting a meta-analysis of clinical efficacy of valproate augmentation therapy in patients with schizophrenia or schizoaffective disorder. Data sources include electronic research through platform of PubMed. Study eligibility criteria, participants, and interventions were as follows: the inclusion criteria included articles discussing comparisons of the treatment effect in schizophrenic patients treated with antipsychotic augmented with valproate and antipsychotics with/without placebo; articles on clinical trials in humans. The exclusion criteria were case reports or series and nonclinical trials. We compared the effect between antipsychotic treatment with valproate augmentation and antipsychotic monotherapy. Data from clinical trials were pooled by random-effects model, and possible confounding variables were examined through meta-regression and subgroup analysis. Data from 11 articles including 889 patients were included into current meta-analysis. We found patients treated with antipsychotics with valproate augmentation showed significantly more improvement in total psychopathology than those treated with antipsychotics only (P = 0.02). Results from open trials, but not from randomized controlled trials (P = 0.20), showed significant improvement (P = 0.01). In addition, the significance only persisted in the studies conducted with a shorter treatment duration (P < 0.001) rather than longer treatment duration (P = 0.23). There is no difference in the dropout rate between valproate augmentation and antipsychotic treatment only (P = 0.14). We could not perform a detailed meta-analysis for every category of antipsychotics, long-term effect, and safety profiles of valproate augmentation therapy in maintenance treatment, safety in pregnant patients, and subtype of schizophrenia. Our meta-analysis highlights the significantly better treatment effect with valproate augmentation therapy in patients with schizophrenia or schizoaffective disorder, and provides important evidence for supporting the practice of valproate augmentation therapy in these patients. PMID:26825886

Learning clinical reasoning.

PubMed

Pinnock, Ralph; Welch, Paul

2014-04-01

Errors in clinical reasoning continue to account for significant morbidity and mortality, despite evidence-based guidelines and improved technology. Experts in clinical reasoning often use unconscious cognitive processes that they are not aware of unless they explain how they are thinking. Understanding the intuitive and analytical thinking processes provides a guide for instruction. How knowledge is stored is critical to expertise in clinical reasoning. Curricula should be designed so that trainees store knowledge in a way that is clinically relevant. Competence in clinical reasoning is acquired by supervised practice with effective feedback. Clinicians must recognise the common errors in clinical reasoning and how to avoid them. Trainees can learn clinical reasoning effectively in everyday practice if teachers provide guidance on the cognitive processes involved in making diagnostic decisions. © 2013 The Authors. Journal of Paediatrics and Child Health © 2013 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

The clinical and cost effectiveness of a virtual fracture clinic service

PubMed Central

Imbuldeniya, A. M.

2017-01-01

Objectives To assess the clinical and cost-effectiveness of a virtual fracture clinic (VFC) model, and supplement the literature regarding this service as recommended by The National Institute for Health and Care Excellence (NICE) and the British Orthopaedic Association (BOA). Methods This was a retrospective study including all patients (17 116) referred to fracture clinics in a London District General Hospital from May 2013 to April 2016, using hospital-level data. We used interrupted time series analysis with segmented regression, and direct before-and-after comparison, to study the impact of VFCs introduced in December 2014 on six clinical parameters and on local Clinical Commissioning Group (CCG) spend. Student’s t-tests were used for direct comparison, whilst segmented regression was employed for projection analysis. Results There were statistically significant reductions in numbers of new patients seen face-to-face (140.4, sd 39.6 versus 461.6, sd 61.63, p < 0.0001), days to first orthopaedic review (5.2, sd 0.66 versus 10.9, sd 1.5, p < 0.0001), discharges (33.5, sd 3.66 versus 129.2, sd 7.36, p < 0.0001) and non-attendees (14.82, sd 1.48 versus 60.47, sd 2.68, p < 0.0001), in addition to a statistically significant increase in number of patients seen within 72-hours (46.4% 3873 of 8345 versus 5.1% 447 of 8771, p < 0.0001). There was a non-significant increase in consultation time of 1 minute 9 seconds (14 minutes 53 seconds sd 106 seconds versus 13 minutes 44 seconds sd 128 seconds, p = 0.0878). VFC saved the local CCG £67 385.67 in the first year and is set to save £129 885.67 annually thereafter. Conclusions We have shown VFCs are clinically and cost-effective, with improvement across several clinical performance parameters and substantial financial savings for CCGs. To our knowledge this is the largest study addressing clinical practice implications of VFCs in England, using robust methodology to adjust for pre-existing trends. Further studies are required to appreciate whether our results are reproducible with local variations in the VFC model and payment tariffs. Cite this article: A. McKirdy, A. M. Imbuldeniya. The clinical and cost effectiveness of a virtual fracture clinic service: An interrupted time series analysis and before-and-after comparison. Bone Joint Res 2017;6:–269. DOI: 10.1302/2046-3758.65.BJR-2017-0330.R1. PMID:28473333

Evaluation of the clinical and antimicrobial effects of the Er:YAG laser or topical gaseous ozone as adjuncts to initial periodontal therapy.

PubMed

Yılmaz, Selçuk; Algan, Serdar; Gursoy, Hare; Noyan, Ulku; Kuru, Bahar Eren; Kadir, Tanju

2013-06-01

The aim of this study was to evaluate the clinical and microbiological results of treatment with the Er:YAG laser and topical gaseous ozone application as adjuncts to initial periodontal therapy in chronic periodontitis (CP) patients. Although many studies have evaluated the effectiveness of the Er:YAG laser as an adjunct to initial periodontal therapy, few studies have focused on the use of gaseous ozone as an adjunct. Thirty patients with CP were randomly divided into three parallel groups, each composed of 10 individuals with at least four teeth having at least one approximal site with a probing depth (PD) of ≥5 mm and a sulcus bleeding index (SBI) ≥2 in each quadrant. Groups of patients received: (1) Scaling and root planing (SRP)+Er:YAG laser; (2) SRP+topical gaseous ozone; or (3) SRP alone. The microbiological and clinical parameters were monitored at day 0 and day 90. At the end of the observation period, statistically significant improvements in clinical parameters were observed within each group. Parallel to the clinical changes, all treatments reduced the number of total bacteria and the proportion of obligately anaerobic microorganisms. Although intergroup comparisons of microbiological parameters showed no significant differences, clinical findings, including attachment gain and PD reduction, were found to be statistically significant in favor of the SRP+Er:YAG laser group. Although statistically nonsignificant, the fact that the obligate anaerobic change was mostly observed in the SRP+Er:YAG laser group, and a similar decrease was noted in the SRP+topical gaseous ozone group, shows that ozone has an antimicrobial effect equivalent to that of the Er:YAG laser.

Facebook advertising for participant recruitment into a blood pressure clinical trial.

PubMed

Nash, Erin L; Gilroy, Deborah; Srikusalanukul, Wichat; Abhayaratna, Walter P; Stanton, Tony; Mitchell, Geoffrey; Stowasser, Michael; Sharman, James E

2017-12-01

Recruitment of sufficient sample size into clinical trials is challenging. Conventional advertising methods are expensive and are often ineffective. The effectiveness of Facebook for recruitment into blood pressure clinical trials of middle-to-older-aged people is unknown. This study aimed to assess this by comparing Facebook advertising with conventional recruitment methods from a retrospective analysis within a clinical trial. Conventional advertisements (newspaper, radio and posters) were employed for the first 20 months of a randomized controlled clinical trial conducted in three Australian capital cities from Tasmania, Queensland and the Australian Capital Territory. With dwindling participant recruitment, at 20 months a Facebook advertising campaign was employed intermittently over a 4-month period. Recruitment results were retrospectively compared with those using conventional methods in the previous 4 months. Compared with conventional recruitment methods, Facebook advertisement was associated with a significant increase in the number of participants recruited in the Australian Capital Territory (from an average 1.8-7.3/month; P < 0.05). There was also an increase in Tasmania that was of borderline significance (from 4.0 participants recruited/month to 9.3/month; P = 0.052). However, there was no effect in Queensland (from 6.0 participants recruited/month to 3.0/month; P = 0.15). Facebook advertisement was associated with a significant decrease in the age of participants enquiring into the study (from 60.9 to 58.7 years; P < 0.001). Facebook advertising was successful in helping to increase recruitment of middle-to-older aged participants into a blood pressure clinical trial, although there may be some variability in effect that is dependent on location.

Clinical and Microbial Evaluation of the Effects on Gingivitis of a Mouth Rinse Containing an Enteromorpha linza Extract

PubMed Central

Cho, Han-Bin; Lee, Hee-Hyun; Lee, Ok-Hwan; Choi, Hyeon-Son; Choi, Jae-Suk

2011-01-01

Abstract Enteromorpha linza, a green alga, has been recognized as a potential source of natural antimicrobial and antifungal compounds. We previously reported that an E. linza extract strongly inhibited the growth of Prevotella intermedia and Porphyromonas gingivalis. The principal objective of this study was to evaluate the clinical effect of a mouth rinse containing the E. linza extract on gingivitis disease, as measured by the plaque index (PI), gingival index (GI), and bleeding on probing (BOP), and on two bacterial strains (P. intermedia and P. gingivalis), in comparison with Listerine® (Listerine-Korea, Seoul, Korea), which was used as a positive control. In total, 55 subjects were recruited into active participation in this clinical study. The PI, GI, BOP, and bacterial strains were then evaluated over a test period of 6 weeks. After 1, 2, 4, and 6 weeks, the same clinical indices were recorded, and the levels of P. intermedia and P. gingivalis were quantified via real-time polymerase chain reaction. At the end of the study, the group using the mouth rinse containing the E. linza extract evidenced significant reductions in the clinical indices (PI, GI, and BOP) and P. gingivalis compared with baseline values. Moreover, E. linza extract containing mouth rinse produced effects similar to those of Listerine. Overall, these results indicate that a mouth rinse containing E. linza extract significantly reduces plaque, improves the condition of gingival tissues, and reduces bleeding. Additionally, E. linza extract mouth rinse significantly inhibits P. gingivalis and P. intermedia. Thus, this clinical study demonstrated that the twice-daily use of an E. linza extract mouth rinse can inhibit and prevent gingivitis. PMID:22145775

Impact of patient position on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials.

PubMed

Alexiou, Vangelis G; Ierodiakonou, Vrettos; Dimopoulos, George; Falagas, Matthew E

2009-12-01

The aim of this study is to summarize the effect of position (prone and semirecumbent 45 degrees ) of mechanically ventilated patients on the incidence of ventilator-associated pneumonia (VAP) and other outcomes. A systematic search for randomized control trials (RCTs) was done. We estimated pooled odds ratios (ORs) and 95% confidence intervals (CIs) using fixed effects model or random effects model, where appropriate. For continuous variables, we calculated the estimation of weighted mean differences. We analyzed data extracted from 3 RCTs studying the semirecumbent 45 degrees and 4 RCTs studying the prone position with a total of 337 and 1018 patients, respectively. The odds of developing clinically diagnosed VAP were significantly lower among patients in the semirecumbent 45 degrees position compared to patients in the supine position (OR = 0.47; 95% CI, 0.27-0.82; 337 patients). The comparison of prone vs supine position group showed a moderate trend toward better outcomes regarding the incidence of clinically diagnosed VAP among patients in the prone position (OR = 0.80; 95% CI, 0.60-1.08; 1018 patients). The subanalysis regarding the incidence of microbiologically documented VAP, the length of intensive care unit stay, and the duration of mechanical ventilation showed that patients in the semirecumbent 45 degrees position have a moderate trend toward better clinical outcomes. This meta-analysis provides additional evidence that the usual practice of back-rest elevation of 15 degrees to 30 degrees is not sufficient to prevent VAP in mechanically ventilated patients. Patients positioned semirecumbently 45 degrees have significantly lower incidence of clinically diagnosed VAP compared to patients positioned supinely. On the other hand, the incidence of clinically diagnosed VAP among patients positioned pronely does not differ significantly from the incidence of clinically diagnosed VAP among patients positioned supinely.

Crying in the Halls: Supervising Students with Symptoms of Emotional Problems in the Clinical Practicum

ERIC Educational Resources Information Center

Storrie, Kim; Ahern, Kathy; Tuckett, Anthony

2012-01-01

There is evidence that the number of university students with mental health problems has increased over the past few years. The literature also suggests that the number and effect of troubled health science students create significant problems in the clinical practicum. However, there are gaps in the literature as to how clinical teachers actually…

The effect of federal funding on clinical productivity: the price of academics.

PubMed

McKenney, Mark M; Livingstone, Alan S; Schulman, Carl

2011-01-01

Research is time consuming and expensive. To offset this expense, federal agencies fund the research, but the financial impact of funded research on clinical surgical productivity has not been studied. The objective is to determine departmental impact of federal funding. The relative value units, professional revenue, and funding were evaluated for clinical Faculty in the Surgery Department for fiscal year 2008. Means were compared using t test, and significance was defined as p<0.05. The Department had 61 clinical surgeons. The Department was divided into three groups based on research funding: unfunded, industry funded, and federally funded. Surgeons with both federal funding and other funding were only included in the federally funded group. There were 42 unfunded, 8 industry funded, and 11 federally funded surgeons. The relative value units, professional revenue, and salary with benefits of the three groups were compared. Federal funding is associated with a significant reduction in clinical work and clinical reimbursement. Federally funded research results in a net loss of revenue for the Surgery Department. The net effect is that the Surgery Department sponsors Federal Research and this has not been previously reported in the literature.

Exogenous insulin antibody syndrome (EIAS): a clinical syndrome associated with insulin antibodies induced by exogenous insulin in diabetic patients.

PubMed

Hu, Xiaolei; Chen, Fengling

2018-01-01

Insulin has been used for diabetes therapy and has achieved significant therapeutic effect. In recent years, the use of purified and recombinant human insulin preparations has markedly reduced, but not completely suppressed, the incidence of insulin antibodies (IAs). IAs induced by exogenous insulin in diabetic patients is associated with clinical events, which is named exogenous insulin antibody syndrome (EIAS). The present review is based on our research and summarizes the characterization of IAs, the factors affecting IA development, the clinical significance of IAs and the treatments for EIAS. © 2018 The authors.

Exogenous insulin antibody syndrome (EIAS): a clinical syndrome associated with insulin antibodies induced by exogenous insulin in diabetic patients

PubMed Central

Hu, Xiaolei

2018-01-01

Insulin has been used for diabetes therapy and has achieved significant therapeutic effect. In recent years, the use of purified and recombinant human insulin preparations has markedly reduced, but not completely suppressed, the incidence of insulin antibodies (IAs). IAs induced by exogenous insulin in diabetic patients is associated with clinical events, which is named exogenous insulin antibody syndrome (EIAS). The present review is based on our research and summarizes the characterization of IAs, the factors affecting IA development, the clinical significance of IAs and the treatments for EIAS. PMID:29233817

A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care.

PubMed

Quanbeck, Andrew; Brown, Randall T; Zgierska, Aleksandra E; Jacobson, Nora; Robinson, James M; Johnson, Roberta A; Deyo, Brienna M; Madden, Lynn; Tuan, Wen-Jan; Alagoz, Esra

2018-01-25

This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

Lack of gender effects on gray matter volumes in adolescent generalized anxiety disorder.

PubMed

Liao, Mei; Yang, Fan; Zhang, Yan; He, Zhong; Su, Linyan; Li, Lingjiang

2014-02-01

Previous epidemiological and clinical studies have reported gender differences in prevalence and clinical features of generalized anxiety disorder (GAD). Such gender differences in clinical phenomenology suggest that the underlying neural circuitry of GAD could also be different in males and females. This study aimed to explore the possible gender effect on gray matter volumes in adolescents with GAD. Twenty-six adolescent GAD patients and 25 healthy controls participated and underwent high-resolution structural magnetic resonance scans. Voxel-based morphometry (VBM) was used to investigate gray matter alterations. Our study revealed a significant diagnosis main effect in the right putamen, with larger gray matter volumes in GAD patients compared to healthy controls, and a significant gender main effect in the left precuneus/posterior cingulate cortex, with larger gray matter volumes in males compared to females. No gender-by-diagnosis interaction effect was found in this study. The relatively small sample size in this study might result in a lack of power to demonstrate gender effects on brain structure in GAD. The results suggested that there are differences in gray matter volumes between males and females, but gray matter volumes in GAD are not influenced by gender. © 2013 Published by Elsevier B.V.

Effects of Storage-Aged RBC Transfusions on Endothelial Function in Hospitalized Patients

PubMed Central

Neuman, Robert; Hayek, Salim; Rahman, Ayaz; Poole, Joseph C.; Menon, Vivek; Sher, Salman; Newman, James L.; Karatela, Sulaiman; Polhemus, David; Lefer, David J.; De Staercke, Christine; Hooper, Craig; Quyyumi, Arshed A.; Roback, John D.

2014-01-01

Background Clinical and animal studies indicate that transfusions of older stored RBCs impair clinical outcomes as compared to fresh RBC transfusions. It has been suggested that this effect is due to inhibition of NO-mediated vasodilation following transfusion of older RBC units. However, to date this effect has not been identified in human transfusion recipients. Study Design and Methods Forty-three hospitalized patients with transfusion orders were randomized to receive either fresh (< 14 days) or older stored (> 21 days) RBC units. Prior to transfusion, and at selected time points after the start of transfusion, endothelial function was assessed using non-invasive flow-mediated dilation assays. Results Following transfusion of older RBC units, there was a significant reduction in NO-mediated vasodilation at 24 hours after transfusion (p=0.045), while fresh RBC transfusions had no effect (p=0.231). Conclusions The present study suggests for the first time a significant inhibitory effect of transfused RBC units stored > 21 days on NO-mediated vasodilation in anemic hospitalized patients. This finding lends further support to the hypothesis that deranged NO signaling mediates adverse clinical effects of older RBC transfusions. Future investigations will be necessary to address possible confounding factors and confirm these results. PMID:25393772

Peer Mentoring During Practicum to Reduce Anxiety in First-Semester Nursing Students.

PubMed

Walker, Danielle; Verklan, Terese

2016-11-01

The clinical setting creates significant anxiety for students that can decrease their ability to learn. This quasi-experimental study examined whether nursing students who participate in peer mentoring during their first clinical experience (n = 18) experienced less anxiety than those in traditional clinical experiences (n = 19). Anxiety was measured using the standardized State Trait Anxiety Index and the Clinical Experiences Anxiety Form (CEAF). Data were analyzed using descriptive and nonparametric statistics. A significant decrease was demonstrated in clinical situation-specific anxiety, as measured by the CEAF, among students who were peer mentored as compared with students who were not. Peer mentoring shows promise as an effective strategy to reduce anxiety among novice nursing students. [J Nurs Educ. 2016;55(11):651-654.]. Copyright 2016, SLACK Incorporated.

Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial.

PubMed

Johannsen, M; O'Toole, M S; O'Connor, M; Jensen, A B; Zachariae, R

2017-02-01

Mindfulness-based intervention has been found efficacious in reducing persistent pain in women treated for breast cancer. Little, however, is known about possible moderators of the effect. We explored clinical and psychological moderators of the effect on pain intensity previously found in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) with women treated for breast cancer with persistent pain. A total of 129 women treated for breast cancer reporting persistent pain were randomized to MBCT or a wait-list control. The primary outcome of pain intensity (11-point numeric rating scale) was measured at baseline, post-intervention, three, and six months follow-up. Proposed clinical moderators included age, axillary lymph node dissection (ALND), radiotherapy, and endocrine treatment. Psychological moderators included psychological distress [the Hospital Anxiety and Depression Scale (HADS)], the adult attachment dimensions anxiety and avoidance [the Experiences in Close Relationships Short Form (the ECR-SF)], and alexithymia [the Toronto Alexithymia Scale (TAS-20)]. Multi-level models were used to test moderation effects over time, i.e. time × group × moderator. Only attachment avoidance (p = 0.03, d = 0.36) emerged as a statistically significant moderator. Higher levels of attachment avoidance predicted a larger effect of MBCT in reducing pain intensity compared with lower levels attachment avoidance. None of the remaining psychological or clinical moderators reached statistical significance. However, based on the effect size, radiotherapy (p = 0.075, d = 0.49) was indicated as a possible clinical moderator of the effect, with radiotherapy being associated with a smaller effect of MBCT on pain intensity over time compared with no radiotherapy. Attachment avoidance, and potentially radiotherapy, may be clinically relevant factors for identifying the patients who may benefit most from MBCT as a pain intervention. Due to the exploratory nature of the analyses, the results should be considered preliminary.

Short-term clinical and microbiologic effects of pocket debridement with an Er:YAG laser during periodontal maintenance.

PubMed

Tomasi, Cristiano; Schander, Kerstin; Dahlén, Gunnar; Wennström, Jan L

2006-01-01

The erbium-doped:yttrium, aluminum, and garnet (Er:YAG) laser is considered a useful tool for subgingival debridement because the laser treatment creates minimal damage to the root surface and has potential antimicrobial effects. The aim of this randomized controlled clinical trial was to evaluate clinical and microbiologic effects of pocket debridement using an Er:YAG laser in patients during periodontal maintenance. Twenty patients at a recall visit for maintenance were consecutively recruited if presenting at least four teeth with residual probing depth (PD) > or = 5 mm. Two pockets in each of two jaw quadrants were randomly assigned to subgingival debridement using 1) an Er:YAG laser (test) or 2) an ultrasonic scaler (control). The laser beam was set at 160 mJ with a pulse frequency of 10 Hz. Clinical variables were recorded at baseline, 1 month, and 4 months after treatment. Primary clinical outcome variables were changes in PD and clinical attachment level (CAL). Microbiologic analysis of subgingival samples was performed at baseline, 2 days, and 30 days after treatment using a checkerboard DNA-DNA hybridization technique against 12 periodontal disease-associated species. The mean initial PD was 6.0 mm (SD: 1.2) in the test group and 5.8 mm (SD: 0.9) in the control group. At 1 month post-treatment, the PD reduction was significantly greater for test than control sites (0.9 versus 0.5 mm; P <0.05). The CAL gain also was significantly greater (0.5 versus 0.06 mm; P <0.01). At the 4-month examination, no significant differences were detected in PD reduction (1.1 versus 1.0 mm) or CAL gain (0.6 versus 0.4 mm). Both treatments resulted in reduction of the subgingival microflora. No significant differences in microbiologic composition were identified between the treatment groups at various time intervals. Degree of treatment discomfort scored significantly lower for the test than the control treatment modality. The results of the trial failed to demonstrate any apparent advantage of using an Er:YAG laser for subgingival debridement, except less treatment discomfort perceived by the patients.

Effect of sedation with detomidine on intraocular pressure with and without topical anesthesia in clinically normal horses.

PubMed

Holve, Dana L

2012-02-01

To determine the effect of sedation with detomidine on intraocular pressure (IOP) in standing horses and whether topical ocular application of anesthetic alters this effect. Clinical trial. 15 clinically normal horses. Horses were assigned to group 1 (n = 7) or 2 (8). Intraocular pressure measurements were obtained at baseline (before sedation) and 10 minutes after IV administration of detomidine (0.02 mg/kg [0.009 mg/lb]). Group 1 horses had an additional IOP measurement at 20 minutes after sedation. For group 2 horses, topical ocular anesthetic was administered 10 minutes prior to baseline IOP measurements. Mean ± SD baseline IOP for horses without topical anesthesia (group 1 horses; IOP, 24.30 ± 3.09 mm Hg) was significantly lower, compared with that of horses with topical anesthesia (group 2 horses; IOP, 30.40 ± 3.25 mm Hg). Compared with baseline values, IOP at 10 minutes after sedation decreased significantly in all horses (by 3.61 ± 1.48 mm Hg and 5.78 ± 4.32 mm Hg in groups 1 and 2, respectively). In group 1 horses, IOP at 10 (20.69 ± 3.45 mm Hg) and 20 (19.96 ± 2.13 mm Hg) minutes after sedation was significantly decreased, compared with baseline values; however, the difference between IOP at 10 versus 20 minutes was not significant. The difference in IOP between group 1 and 2 horses at 10 minutes after sedation was not significant. IV administration of detomidine caused a decrease in IOP in clinically normal horses and may be a safe sedative when performing ocular procedures.

Vitamin D Supplementation for Depressive Symptoms: A Systematic Review and Meta-analysis of Randomized Controlled Trials

PubMed Central

Shaffer, Jonathan A.; Edmondson, Donald; Wasson, Lauren Taggart; Falzon, Louise; Homma, Kirsten; Ezeokoli, Nchedcochukwu; Li, Peter; Davidson, Karina W.

2014-01-01

Objective To review the effects of vitamin D supplementation on depression or depressive symptoms in randomized controlled trials. Although low vitamin D levels have been observationally associated with depression and depressive symptoms, the effect of vitamin D supplementation as an antidepressant remains uncertain. METHODS MEDLINE, CINAHL, Allied and Complimentary Medicine Database, PsycINFO, Scopus, and The Cochrane Library, and references of included reports (through May 2013) were searched. Two independent reviewers identified randomized trials that compared the effect of vitamin D supplementation on depression or depressive symptoms to a control condition. Two additional reviewers independently reviewed and extracted relevant data; disagreements were reconciled by consensus. The Cochrane Risk of Bias Tool was used to assess study quality. Seven trials (3191 participants) were included. RESULTS Vitamin D supplementation had no overall effect on depressive symptoms (standardized mean difference [SMD], −0.14; 95% CI, −0.33 to 0.05; P = 0.16), although considerable heterogeneity was observed. Subgroup analysis showed that vitamin D supplementation for participants with clinically significant depressive symptoms or depressive disorder had a moderate, statistically significant effect (2 studies: SMD, −0.60; 95% CI, −1.19 to −0.01; P = 0.046), but a small, nonsignificant effect for those without clinically significant depression (5 studies: SMD, −0.04; CI, −0.20 to 0.12; P = 0.61). Most trials had unclear or high risk of bias. Studies varied in the amount, frequency, duration, and mode of delivery of vitamin D supplementation. Conclusion Vitamin D supplementation may be effective for reducing depressive symptoms in patients with clinically significant depression; however, further high quality research is needed. PMID:24632894

Effect of Olanzapine on Clinical and Polysomnography Profiles in Patients with Schizophrenia

PubMed Central

Sarkar, Sukanto; Nizamie, S. Haque

2018-01-01

Acute and short-term administration of olanzapine has a favorable effect on sleep in schizophrenia patients. This study aimed to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients during the acute phase of illness after controlling for previous drug exposure. Twenty-five drug-naïve or drug-free schizophrenia patients were assessed at baseline and after six weeks of olanzapine treatment on Brief Psychiatric Rating Scale (BPRS), Positive and Negative Syndrome Scale (PANSS), and Udvalg for Kliniske Undersogelser (UKU) side-effect rating scale and a whole-night polysomnography; fifteen patients completed the study. There was a significant reduction in all psychopathological variables with maximum reduction in PANSS total, BPRS total, and PANSS positive scores. A significant increase in total sleep time (TST), sleep efficiency (SE), nonrapid eye movement (NREM) stage 1 duration, stage 3 duration, stage 4 duration, and stage 4 percentage of TST, number of rapid eye movement (REM) periods, REM duration, and REM percentage of TST was observed. REM latency at baseline inversely predicted the reduction in BPRS total and PANSS total and positive scores. In summary, short-term treatment with olanzapine produced significant improvement in clinical and polysomnography profiles of patients with schizophrenia with shorter REM latency predicting a good clinical response. PMID:29675276

Effect of nutritional supplementation of breastfeeding HIV positive mothers on maternal and child health: findings from a randomized controlled clinical trial

PubMed Central

2011-01-01

Background It has been well established that breastfeeding is beneficial for child health, however there has been debate regarding the effect of lactation on maternal health in the presence of HIV infection and the need for nutritional supplementation in HIV positive lactating mothers. Aims To assess the effect of nutritional supplementation to HIV infected lactating mothers on nutritional and health status of mothers and their infants. Methods A randomized controlled clinical trial to study the impact of nutritional supplementation on breastfeeding mothers. Measurements included anthropometry; body composition indicators; CD4 count, haemoglobin and albumin; as well as incidence rates of opportunistic infections; depression and quality of life scores. Infant measurements included anthropometry, development and rates of infections. Results The supplement made no significant impact on any maternal or infant outcomes. However in the small group of mothers with low BMI, the intake of supplement was significantly associated with preventing loss of lean body mass (1.32 kg vs. 3.17 kg; p = 0.026). There was no significant impact of supplementation on the infants. Conclusions A 50 g daily nutritional supplement to breastfeeding mothers had no or limited effect on mother and child health outcomes. Clinical trial registration ISRCTN68128332 (http://www.controlled-trials.com/ISRCTN68128332) PMID:22192583

Treatment of the alcoholic organic brain syndrome: double-blind, placebo-controlled clinical, psychometric and electroencephalographic mapping studies with modafinil.

PubMed

Saletu, B; Saletu, M; Grünberger, J; Frey, R; Anderer, P; Mader, R

1993-01-01

In a double-blind study 40 abstinent hospitalized male patients with an alcoholic organic brain syndrome (OBS; ICD 9: 291.2) were treated for 6 weeks with either placebo or 200 mg modafinil b.i.d. Modafinil (CRL 40476) is a vigilance-promoting, putative central alpha 1-adrenergic agonist with a pharmacological profile quite different from that of amphetamine. Clinical investigations demonstrated that the spontaneous remission of the alcoholic OBS was augmented and accelerated by modafinil, which was found significant as compared with placebo by confirmatory statistics in the target variable, the Clinical Global Impression scale. The drug was well tolerated. Psychometric tests revealed significant improvement of the noopsyche after modafinil as compared with placebo, while the thymopsyche and psychophysiological measurements were not affected. Electroencephalographic mapping showed significant differences between the central effects of modafinil and placebo indicating an improvement of vigilance under modafinil. Typical vigilance-promoting properties were seen after acute drug administration, were less evident before the morning dose after chronic treatment but re-occurred after super-imposed daily drug administration. Thus, our clinical, psychometric and neurophysiological investigations in alcoholic OBS patients demonstrated a therapeutic effect of modafinil in the early phase of abstinence.

Effect of biomagnetic therapy versus physiotherapy for treatment of knee osteoarthritis: a randomized controlled trial.

PubMed

Gremion, Gerald; Gaillard, David; Leyvraz, Pierre-Francois; Jolles, Brigitte M

2009-11-01

To assess the effectiveness of pulsed signal therapy in the treatment of knee osteoarthritis (Kellgren II or III). A randomized, double-blind controlled clinical trial. The first 95 patients sent to the clinic with knee osteo-arthritis were selected and randomized into treatment with pulsed signal therapy or conventional physiotherapy. Assessment included recording of usual demographic data, pertinent history, baseline medication and radiographs. Clinical evaluation was made at baseline, 6 weeks and 6 months after the end of treatment by the same blinded doctor. At each follow-up time, the patient was asked to complete a visual analogue pain scale and a Lequesne score. The doctor recorded the degree of pain on motion and the ability to move the affected knee. Both treatments resulted in significant improvements in pain and physical function. A statistical difference was observed only for activities of daily living, where the physiotherapy was more efficient (p<0.03). The cost of treatment with pulsed signal therapy was significantly higher, double the treatment cost of conventional physiotherapy. Like physiotherapy, pulsed signal therapy has improved the clinical state of treated patients but with no significant statistical difference. Pulsed signal therapy is, however, more expensive.

Maternal social support, quality of birth experience, and post-partum depression in primiparous women.

PubMed

Tani, Franca; Castagna, Valeria

2017-03-01

Social relationships provide individuals with a general sense of self-worth, psychological wellbeing, as well as allowing them access to resources during stressful periods and transitions in life. Pregnancy is a time of significant life change for every woman. The aim of this study was to verify the influence of social support perceived by mothers during pregnancy on the quality of their birth experience and post-partum depression. A longitudinal study at three different times was carried out on 179 nulliparous pregnant women. Women completed a Maternal Social Support Questionnaire during the third trimester of their pregnancy. Then, on the first day after childbirth, clinical birth indices were collected. Finally, a month after childbirth, the Edinburgh Postnatal Depression Scale was administered. Post-partum depression was influenced negatively by maternal perceived social support and positively by negative clinical birth indices. In addition to these direct effects, analyses revealed a significant effect of maternal perceived social support on post-partum depression, mediated by the clinical indices considered. Social support perceived by mothers during pregnancy plays a significant role as a protection factor against post-partum depression, both directly and indirectly, reducing the negative clinical aspects of the birth experience.

[The effectiveness of fenspiride in the treatment of patients with chronic obstructive pulmonary disease].

PubMed

Butorov, S I; Muntianu, V I

2007-01-01

The purpose of the study was to assess the effectiveness and safety of long-term application of fenspiride, an anti-inflammatory drug, in patients with chronic obstructive pulmonary disease (COPD) under outpatient conditions. The drug was studied on 24 COPD patients. Fenspiride application resulted in improvement in bronchoobstructive syndrome and external respiration parameters, as well as a significant increase in exercise tolerance. In patients with stable stage I COPD, the use of fenspiride as a part of therapeutic regimen leads to better clinical results than in stage II patients. Long-term application of fenspiride in medium therapeutic doses under outpatient conditions is associated with positive clinical effects and leads to significant improvement in quality of life.

American association of poison control centers database characterization of human tilmicosin exposures, 2001-2005.

PubMed

Oakes, Jennifer; Seifert, Steven

2008-12-01

Tilmicosin is a veterinary antibiotic with significant human toxicity at doses commonly used in animals, but the parenteral dose-response relationship has not been well characterized. Human exposures to tilmicosin in the database of the American Association of Poison Control Centers (AAPCC) from 2001 to 2005 were analyzed for demographic associations, exposure dose, clinical effects and outcomes. Over the 5-year period, there were 1,291 single-substance human exposures to tilmicosin. The mean age was 39.1 years, and 80% were male. By route there were 768 (54%) parenteral exposures. Patients with parenteral exposures had a significantly increased likelihood of being seen at a healthcare facility, admission, and admission to an ICU. With nonparenteral exposure, most had no clinical effects or minor effects, and there were no major effects or deaths. With parenteral exposure, moderate effects occurred in 46 (6%), major effects in 2 (0.3%) and there were 4 (0.5%) deaths, two of which were suicides. A dose-response relationship could be demonstrated. Clinical effect durations of up to a week occurred at even the lowest dose range. Over 250 cases of human tilmicosin exposure are reported to poison centers per year and over 150 of those are parenteral. Most exposures produce no or minor effects, but fatalities have occurred with parenteral exposure. The case fatality rate in parenteral exposures is 10 times the case fatality rate for all human exposures in the AAPCC database. Significant adverse and prolonged effects are reported at parenteral doses > 0.5 mL, suggesting that all parenteral exposures should be referred for healthcare facility evaluation.

History of Childhood Abuse, Drinking Motives, Alcohol Use, and Sexual Risk Behavior Among STD Clinic Patients in St. Petersburg, Russia: A Cross-Sectional Study.

PubMed

Abdala, Nadia; Li, Fangyong; Shaboltas, Alla V; Skochilov, Roman V; Krasnoselskikh, Tatiana V

2016-03-01

The relationship between level of childhood abuse (physical and emotional) and sexual risk behavior of sexually transmitted disease clinic patients in St. Petersburg, Russia was examined through path analyses. Mediating variables investigated were: Alcohol Use Disorder Identification Test (AUDIT), drinking motives (for social interaction, to enhance mood, to facilitate sexual encounters), intimate partner violence (IPV), anxiety, and depression symptoms. Results showed a significant indirect effect of childhood abuse on women's sexual risk behavior: higher level of childhood abuse was associated with a greater likelihood of IPV, motivations to drink, leading to higher AUDIT scores and correlated to higher likelihood of having multiple, new or casual sexual partner(s). No significant effect was identified in paths to condom use. Among men, childhood abuse had no significant effect on sexual risk behavior. Reduction in alcohol-related sexual risk behavior may be achieved by addressing the effects of childhood abuse among female participants.

History of Childhood Abuse, Drinking Motives, Alcohol Use, and Sexual Risk Behavior among STD clinic patients in St. Petersburg, Russia: a cross-sectional study

PubMed Central

Abdala, Nadia; Li, Fangyong; Shaboltas, Alla V.; Skochilov, Roman V.; Krasnoselskikh, Tatiana V.

2015-01-01

The relationship between level of childhood abuse (physical and emotional) and sexual risk behavior of sexually transmitted disease (STD) clinic patients in St. Petersburg, Russia was examined through path analyses. Mediating variables investigated were: Alcohol Use Disorder Identification Test (AUDIT), drinking motives (for social interaction, to enhance mood, to facilitate sexual encounters), intimate partner violence (IPV), anxiety, and depression symptoms. Results showed a significant indirect effect of childhood abuse on women’s sexual risk behavior: higher level of childhood abuse was associated with a greater likelihood of IPV, motivations to drink, leading to higher AUDIT scores and correlated to higher likelihood of having multiple, new or casual sexual partner(s). No significant effect was identified in paths to condom use. Among men, childhood abuse had no significant effect on sexual risk behavior. Reduction in alcohol-related sexual risk behavior may be achieved by addressing the effects of childhood abuse among female participants. PMID:25801476

Gender and culture differences in the quality of life among Americans and Koreans with atrial fibrillation.

PubMed

Kang, Younhee

2009-09-01

This study examined the gender and culture differences in relation to the quality of life among Americans and Koreans with atrial fibrillation. It employed secondary data analysis and a descriptive comparative design. The settings were the cardiology outpatient clinics and the outpatient clinic in two urban hospitals in the USA and one university hospital in Korea. The quality of life was measured by the Short-Form Health Survey. The data from 129 subjects were analyzed by two-way ANCOVA and a post-hoc test. In relation to physical function, there was a statistically significant effect shown by gender, but no significant differences were found by the main effect of culture and the interaction effect of gender and culture. The significant interaction effect of gender and culture on mental health was shown. In conclusion, gender differences in the quality of life perceived by patients with atrial fibrillation varied with their cultural background. Thus, patients' cultural background should be considered in nursing practice.

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

PubMed

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

2016-03-01

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

Clinical chemistry and hematology values in a Caribbean population of African green monkeys.

PubMed

Liddie, Shervin; Goody, Robin J; Valles, Rodrigo; Lawrence, Matthew S

2010-12-01

Hematology and clinical chemistry (HCC) reference values are critical in veterinary practice and in vivo pre-clinical research, enabling detection of health abnormalities, response to therapeutic intervention or adverse toxicological effects, as well as monitoring of clinical management. In this report, reference ranges for 46 HCC parameters were characterized in 331 wild-caught and colony-bred African green monkeys. Effects of sex, weight and duration of captivity were determined by one-way analysis of variance. Significant sex differences were observed for several HCC parameters. Significant differences were also observed for select HCC variables between newly caught animals and those held in captivity for 1-12 months or longer. Comparison of this data with other non-human primate species and humans highlights similarities and disparities between species. Potential causes of interpopulation variability and relevance to the use of the African green monkey as a non-human primate model are discussed. © 2010 John Wiley & Sons A/S.

Predicting academic performance and clinical competency for international dental students: seeking the most efficient and effective measures.

PubMed

Stacey, D Graham; Whittaker, John M

2005-02-01

Measures used in the selection of international dental students to a U.S. D.D.S. program were examined to identify the grouping that most effectively and efficiently predicted academic performance and clinical competency. Archival records from the International Dental Program (IDP) at Loma Linda University provided data on 171 students who had trained in countries outside the United States. The students sought admission to the D.D.S. degree program, successful completion of which qualified them to sit for U.S. licensure. As with most dental schools, competition is high for admission to the D.D.S. program. The study's goal was to identify what measures contributed to a fair and accurate selection process for dental school applicants from other nations. Multiple regression analyses identified National Board Part II and dexterity measures as significant predictors of academic performance and clinical competency. National Board Part I, TOEFL, and faculty interviews added no significant additional help in predicting eventual academic performance and clinical competency.

Improving the relevance and consistency of outcomes in comparative effectiveness research

PubMed Central

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

2016-01-01

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

Clinical pharmacology of sibutramine hydrochloride (BTS 54524), a new antidepressant, in healthy volunteers.

PubMed Central

King, D J; Devaney, N

1988-01-01

The cardiovascular, anticholinergic and central effects of single doses of 30, 45 and 60 mg of sibutramine hydrochloride (BTS 54524), a new potential antidepressant, were compared with amitriptyline (50 mg) and placebo given at weekly intervals in a randomised design to six healthy male volunteers. Sibutramine was associated with increases in both supine heart rate and systolic blood pressure at 1, 2 and 6 h after 60 mg (P less than 0.05). Amitriptyline caused a significant 50-60% decrease in salivation compared with placebo at 2 and 6 h but there were no changes with sibutramine. No significant changes in pupil size were detected with either drug. Visual analogue rating scales (VARS) revealed significant drowsiness with amitriptyline but neither sedative nor stimulant effects with sibutramine. Impairments of simple auditory and visual reaction times, visual two-choice reaction time, finger tapping and trail making, measured using an automated test battery, occurred with amitriptyline compared with sibutramine. If sibutramine proves to be an effective antidepressant it should be devoid of anticholinergic or central depressant effects. Chronic dosage studies are indicated to evaluate the clinical significance of its cardiovascular effects. PMID:3207566

Is supervision necessary? Examining the effects of internet-based CBT training with and without supervision.

PubMed

Rakovshik, Sarah G; McManus, Freda; Vazquez-Montes, Maria; Muse, Kate; Ougrin, Dennis

2016-03-01

To investigate the effect of Internet-based training (IBT), with and without supervision, on therapists' (N = 61) cognitive-behavioral therapy (CBT) skills in routine clinical practice. Participants were randomized into 3 conditions: (1) Internet-based training with use of a consultation worksheet (IBT-CW); (2) Internet-based training with CBT supervision via Skype (IBT-S); and (3) "delayed-training" controls (DTs), who did not receive the training until all data collection was completed. The IBT participants received access to training over a period of 3 months. CBT skills were evaluated at pre-, mid- and posttraining/wait using assessor competence ratings of recorded therapy sessions. Hierarchical linear analysis revealed that the IBT-S participants had significantly greater CBT competence at posttraining than did IBT-CW and DT participants at both the mid- and posttraining/wait assessment points. There were no significant differences between IBT-CW and the delayed (no)-training DTs. IBT programs that include supervision may be a scalable and effective method of disseminating CBT into routine clinical practice, particularly for populations without ready access to more-traditional "live" methods of training. There was no evidence for a significant effect of IBT without supervision over a nontraining control, suggesting that merely providing access to IBT programs may not be an effective method of disseminating CBT to routine clinical practice. (c) 2016 APA, all rights reserved).

Effectiveness outcomes in attention-deficit/hyperactivity disorder.

PubMed

Weiss, Margaret D; Gadow, Kenneth; Wasdell, Michael B

2006-01-01

Attention-deficit/hyperactivity disorder (ADHD) is common, chronic, and associated with significant functional impairment. It is highly treatable. It is therefore not only a major public health problem but also one that provides a unique opportunity in medicine to make a significant difference. This article will discuss the methodology needed to demonstrate empirically the impact of treatment on actual burden of illness in practice. Where efficacy studies demonstrate whether a treatment can work, effectiveness studies tell us whether they actually do work. Clinical trials exclude incompetent, non-compliant, and seriously comorbid patients, so that the information obtained from these trials tells us the most about the patients we see the least. Small differences in effect size in pivotal trials of efficacy have become a key variable for rating treatments as first line or second line, without consideration of effectiveness variables such as comorbidity, difficulty with appetite or sleep, patient preference, capacity for compliance, timing of functional impairment, and substance use. These effectiveness variables are less well studied, but critical to clinical decision making. In reality, fewer than 10% of our patients comply with and persist with treatment. To learn more about why patients are discontinuing treatment, we need to explore measures of effectiveness empirically. Effectiveness studies are also important to provide regulatory bodies with the data they need to balance the risk of treatment with the risk of failing to treat. Practical clinical trials and naturalistic follow-up studies will allow us to evaluate the true clinical impact of short-term efficacy trials.

[Evaluation of the clinical effect of the teeth with subgingivally involved defect conserved by crown lengthening surgery].

PubMed

Wang, Yong; Ding, Xiao-Hong; Yao, Li-Li; Huang, Zhong-Suo; Bian, Hua-Qin

2005-02-01

To evaluate the clinical effect of the teeth with subgingivally involved defect which were conserved by crown lengthening surgery. 62 teeth, with defect subgingivally from 1.5 mm to 4 mm, mobility degree(MD)0.05), but a significant increase about MD occurred in the major defect group one year after restoration (P<0.01), and there was significant correlation between MD of each stage after operation and PD of pre-operation in anterior teeth (r=0.489, 0.526, 0.531, P<0.01). According to the biological width principle, crown lengthening surgery may conserve these teeth with subgingivally involved defect, and has a good, long-time clinical effect. But MD showed an increasing trend after operation and significant cor.

Unexpected individual clinical site variation in eradication rates of group a streptococci by penicillin in multisite clinical trials.

PubMed

Kaplan, Edward L; Oakes, J Michael; Johnson, Dwight R

2007-12-01

Previously, we reported an unexpectedly large percentage of failures by penicillin to eradicate group A streptococci (GAS) from the upper respiratory tract. Because penicillin has been the recommended therapy for the treatment of GAS pharyngitis, our report prompted controversy. Data from clinical trials in which our laboratory has participated demonstrated marked variation in GAS eradication rates among clinical sites. The reasons for such variation have never been adequately examined. We performed statistical analyses of site variation in eradication rates to assess the potential effect on reported reduced penicillin efficacy. Penicillin GAS eradication rates were compared using data from 4 large multisite pharyngitis treatment trials (75 clinical sites; 1158 subjects). Variation in eradication rates among clinical sites was statistically evaluated [chi(2) tests and generalized estimating equation (GEE) regression models]. There was significant site-to-site variation in GAS eradication rates in each of the trials (range, 17-100%; P < 0.005) as well as between separate trials (mean range, 58-69%; P < 0.033). GEE modeling indicated that GAS eradication rates were significantly higher for clinical sites participating in more than one clinical trial. The statistically significant site-to-site variation in penicillin eradication rates was related to factors (dependencies) at individual sites. Such factors may affect assessment of therapeutic efficacy and indicate a necessity for considering clinical site variation before reporting pooled efficacy data from multiple sites; combined data may result in misleading clinical implications. This is the first report documenting significant variation resulting from individual clinical site-related factors and offers a possible explanation for reduced penicillin eradication.

Breaking significant news: The experience of clinical nurse specialists in cancer and palliative care.

PubMed

Mishelmovich, Nina; Arber, Anne; Odelius, Anki

2016-04-01

The aim of the research was to explore specialist cancer and palliative care nurses experience of delivering significant news to patients with advanced cancer. A qualitative phenomenological research study was conducted to capture nurses' experiences with the aim of understanding how cancer and palliative care clinical nurse specialists work towards disclosure of advanced and terminal cancer. Data were collected through semi-structured interviews with 10 clinical nurse specialists working in one acute NHS trust. Clinical nurse specialists were recruited from the following specialities: lung cancer, breast cancer, gynaecological cancer, upper and lower gastrointestinal cancer and palliative care. Four themes emerged from the data: importance of relationships; perspective taking; ways to break significant news; feeling prepared and putting yourself forward. The findings revealed that highly experienced clinical nurse specialists (CNSs) felt confident in their skills in delivering significant news and they report using patient centred communication to build a trusting relationship so significant news was easier to share with patients. CNSs were aware of guidelines and protocols for breaking significant and bad news but reported that they used guidelines flexibly and it was their years of clinical experience that enabled them to be effective in disclosing significant news. Some areas of disclosure were found to be challenging in particular news of a terminal prognosis to patients who were of a younger age. CNSs have become more directly involved in breaking significant news to those with advanced cancer by putting themselves forward and feeling confident in their skills. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effectiveness of one-year pharmacological treatment of adult attention-deficit/hyperactivity disorder (ADHD): an open-label prospective study of time in treatment, dose, side-effects and comorbidity.

PubMed

Fredriksen, Mats; Dahl, Alv A; Martinsen, Egil W; Klungsøyr, Ole; Haavik, Jan; Peleikis, Dawn E

2014-12-01

How to generalize from randomized placebo controlled trials of ADHD drug treatment in adults to 'real-world' clinical practice is intriguing. This open-labeled prospective observational study examined the effectiveness of long-term stimulant and non-stimulant medication in adult ADHD including dose, side-effects and comorbidity in a clinical setting. A specialized ADHD outpatient clinic gave previously non-medicated adults (n=250) with ADHD methylphenidate as first-line drug according to current guidelines. Patients who were non-tolerant or experiencing low efficacy were switched to amphetamine or atomoxetine. Primary outcomes were changes of ADHD-symptoms evaluated with the Adult ADHD Self-Report Scale (ASRS) and overall severity by the Global Assessment of Functioning (GAF). Secondary outcomes were measures of mental distress, and response on the Clinical-Global-Impressions-Improvement Scale. Data at baseline and follow-ups were compared in longitudinal mixed model analyses for time on-medication, dosage, comorbidity, and side-effects. As results, 232 patients (93%) completed examination at the 12 month endpoint, and 163 (70%) remained on medication. Compared with the patients who discontinued medication, those still on medication had greater percentage reduction in ASRS-scores (median 39%, versus 13%, P<0.001) and greater improvement of GAF (median 20% versus 4%, P<0.001) and secondary outcomes. Continued medication and higher cumulated doses showed significant associations to sustained improvement. Conversely, psychiatric comorbidity and side-effects were related to lower effectiveness and more frequent termination of medication. Taken together, one-year treatment with stimulants or atomoxetine was associated with a clinically significant reduction in ADHD symptoms and mental distress, and improvement of measured function. No serious adverse events were observed. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

Add-on clinical effects of selective antagonist of 5HT6 receptors AVN-211 (CD-008-0173) in patients with schizophrenia stabilized on antipsychotic treatment: pilot study.

PubMed

Morozova, Margarita A; Lepilkina, Taisiya A; Rupchev, Georgy E; Beniashvily, Allan G; Burminskiy, Denis S; Potanin, Sergey S; Bondarenko, Evgeny V; Kazey, Vasily I; Lavrovsky, Yan; Ivachtchenko, Alexandre V

2014-08-01

The serotoninergic system as a target for add-on treatment seems to be a promising approach in patients with schizophrenia. To clarify if selective 5HT-6 antagonist AVN-211 (CD-008-0173) adds clinical and cognitive effects to stable antipsychotic treatment. A randomized, double-blind, placebo-controlled, add-on, 4r-week trial in 47 schizophrenia patients (21 patients receiving study drug and 26 receiving placebo) who were stabilized on antipsychotic medication was performed. Seventeen patients from the study drug group and 25 patients from the placebo group completed the trial. Treatment effects were measured using clinical rating scales and attention tests. With no differences at baseline, there was a significant difference between the groups in Positive and Negative Syndrome Scale (PANSS) positive subscale score (p = 0.058) in favor of patients in the treatment group at the endpoint. The PANSS positive subscore (p = 0.0068) and Clinical Global Impression-Severity (CGI-S) (p = 0.048) score significantly changed only in the treatment group. Only in the placebo group were significant changes in Calgary Depression Rating Scale (CDRS) total score registered. The indices of attention tests at endpoint did not show differences between the groups, with the exception of the scope of change in the results of the subtest VIII of the Wechsler Adult Intelligence Scale (WAIS), which showed difference between the groups (p = 0.02) and was significantly larger in the treatment group. Only inside the study drug group, significant changes in selectivity and continuous attention were observed regarding total correct responses (p = 0.0038) and reaction time (p = 0.058) in the Continuous Attention Task (CAT) test. Selective 5HT6 antagonist AVN-211 (CD-008-0173) added antipsychotic and some procognitive (attention) effects to antipsychotic medication.

Do counsellors in general practice surgeries and clinical psychologists in the National Health Service see the same patients?

PubMed Central

Burton, M V; Sadgrove, J; Selwyn, E

1995-01-01

An audit was conducted of a counsellor's work over the period 1989-1993 at two general practice surgeries in Coventry. Comparative data were available for general practitioner (GP)-referred patients seen in the district clinical psychology department in Coventry during 1988-1992. The counsellor saw significantly more patients referred with anxiety, depression, marital problems, child management and physical illness than did psychologists, whilst psychologists saw significantly more patients with relationship problems and personality disorders. To the question, 'Are these services effective?' the answer is yes, both services are effective, but they are treating different patient populations. PMID:7769604

Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial

PubMed Central

Demarin, Vida; Bašić Kes, Vanja; Trkanjec, Zlatko; Budišić, Mislav; Bošnjak Pašić, Marija; Črnac, Petra; Budinčević, Hrvoje

2017-01-01

Objectives The aim of this randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of Ginkgo biloba extract in patients diagnosed with vascular cognitive impairment (VCI). Methods A total of 90 patients (aged 67.1±8.0 years; 59 women) were randomly allocated (1:1:1) to receive G. biloba 120 mg, G. biloba 60 mg, or placebo during a 6-month period. Assessment was made for efficacy indicators, including neuropsychological tests scores (Sandoz Clinical Assessment Geriatric Scale, Folstein Mini-Mental State Examination, Mattis Dementia Rating Scale, and Clinical Global Impression) and transcranial Doppler ultrasound findings. Safety indicators included laboratory findings, reported adverse reactions, and clinical examination. Results At the end of 6-month study period, G. biloba 120 and 60 mg showed a statistically significant positive effect in comparison with placebo only on the Clinical Global Impression score (2.6±0.8 vs 3.1±0.7 vs 2.8±0.7, respectively; P=0.038). The Clinical Global Impression score showed a significant deterioration from the baseline values in the placebo group (−0.3±0.5; P=0.021) as opposed to G. biloba groups. No significant differences were found in the transcranial Doppler ultrasound findings. Adverse reactions were significantly more common and serious in the placebo group (16 subjects) than in either of the two G. biloba extract groups (eight and nine subjects, respectively), whereas laboratory findings and clinical examinations revealed no differences between the groups receiving G. biloba extract and placebo. Conclusion According to our results, G. biloba seemed to slow down the cognitive deterioration in patients with VCI, but the effect was shown in only one of the four neuropsychological tests administered. However, because of this mild effect in combination with a few adverse reactions, we cannot say that it is ineffective or unsafe either. Further studies are still needed to provide unambiguous evidence on the efficacy and safety of G. biloba extract. PMID:28243101

Efficacy and Safety of Daikenchuto for Constipation and Dose-Dependent Differences in Clinical Effects

PubMed Central

Shinoda, Yasutaka; Kuroda, Ayaka; Yoshida, Aya; Mitsuoka, Machiko; Mori, Kouki; Kawachi, Yuki; Moriya, Akihiro; Tanaka, Kouji; Takeda, Atsuko; Yoshimura, Tomoaki; Sugiyama, Tadashi

2018-01-01

Background Daikenchuto (DKT) is a Kampo medicine used for the treatment of constipation. In this study, we evaluated the effectiveness of DKT against constipation. Patients and Methods Thirty-three patients administered DKT for constipation were selected and divided into low-dose (7.5 g DKT; n = 22) and high-dose (15 g DKT; n = 11) groups. We retrospectively evaluated weekly defaecation frequency, side effects, and clinical laboratory data. Results Median defaecation frequencies after DKT administration (5, 5.5, 5, and 8 for the first, second, third, and fourth weeks, resp.) were significantly higher than that before DKT administration (2) in all 33 cases (P < 0.01). One case (3%) of watery stool, one case of loose stools (3%), and no cases of abdominal pain (0%) were observed. Median defaecation frequencies in the high-dose group (7 and 9) were significantly higher than those in the low-dose group (4 and 3) in the first (P = 0.0133) and second (P = 0.0101) weeks, respectively. There was no significant change in clinical laboratory values. Conclusion We suggest that DKT increases defaecation frequency and is safe for treating constipation. PMID:29693001

Chest shielding for prevention of a haemodynamically significant patent ductus arteriosus in preterm infants receiving phototherapy.

PubMed

Bhola, Kavita; Foster, Jann P; Osborn, David A

2015-11-03

Patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. Phototherapy is a common treatment for jaundice in preterm infants. However, phototherapy has been associated with failure of closure of the ductus arteriosus in preterm infants. To determine if chest shielding of preterm infants receiving phototherapy reduces the incidence of clinically and/or haemodynamically significant PDA and reduces morbidity secondary to PDA. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library; 2015, Issue 3), MEDLINE, EMBASE, CINAHL, previous reviews, cross-references, abstracts, proceedings of scientific meetings, and trial registries through March 2015. Randomised controlled trials (RCTs), cluster-RCTs, or quasi-RCTs of chest shielding during phototherapy compared to sham shielding or no shielding for the prevention of a haemodynamically or clinically significant PDA in preterm infants. Three review authors independently assessed studies for eligibility and quality and extracted data. We defined a clinically significant PDA as the presence of a PDA with clinical signs of an effect on organ function attributable to the ductus arteriosus. We defined a haemodynamically significant PDA as clinical and/or echocardiographic signs of a significant ductus arteriosus effect on blood flow. We included two small trials enrolling very preterm infants (Rosenfeld 1986; Travadi 2006). We assessed both as at high risk of bias. No study reported clinically significant PDA, defined as the presence of a PDA with clinical symptoms or signs attributable to the effect of a ductus arteriosus on organ function. Rosenfeld 1986 reported a non-significant reduction in haemodynamically significant PDA with left atrial to aortic root ratio greater than 1.2 (risk ratio (RR) 0.23, 95% confidence interval (CI) 0.05 to 1.01; 74 infants) but a statistically significant risk difference (RD -0.18, 95% CI -0.34 to -0.03; number needed to treat for an additional beneficial outcome (NNTB) 5, 95% CI 3 to 33). Rosenfeld 1986 reported a significant reduction in PDA detected by murmur (RR 0.50, 95% CI 0.29 to 0.88; RD -0.30, 95% CI -0.52 to -0.08; NNTB 3, 95% CI 2 to 12; 74 infants). Rosenfeld 1986 reported a significant reduction in treatment with indomethacin (RR 0.12, 95% CI 0.02 to 0.88; RD -0.21, 95% CI -0.35 to -0.06; NNTB 5, 95% CI 3 to 17; 74 infants), and only one infant had a ductal ligation in the no-shield group. There were no other significant outcomes, including mortality to discharge or 28 days, days in oxygen, days on mechanical ventilation, days in hospital, intraventricular haemorrhage, retinopathy of prematurity, or exchange transfusion. The available evidence is very low quality and insufficient to assess the safety or efficacy of chest shield during phototherapy for prevention of PDA in preterm infants. Further trials of chest shielding are warranted, particularly in settings where infants are not receiving prophylactic or early echocardiographic targeted cyclo-oxygenase inhibitors for PDA.

A peer learning intervention for nursing students in clinical practice education: A quasi-experimental study.

PubMed

Pålsson, Ylva; Mårtensson, Gunilla; Swenne, Christine Leo; Ädel, Eva; Engström, Maria

2017-04-01

Studies of peer learning indicate that the model enables students to practice skills useful in their future profession, such as communication, cooperation, reflection and independence. However, so far most studies have used a qualitative approach and none have used a quasi-experimental design to study effects of nursing students' peer learning in clinical practice. To investigate the effects of peer learning in clinical practice education on nursing students' self-rated performance. Quasi-experimental. The study was conducted during nursing students' clinical practice. All undergraduate nursing students (n=87) attending their first clinical practice were approached. Seventy students out of 87 answered the questionnaires at both baseline and follow-up (42 of 46 in the intervention group and 28 of 39 in the comparison group). During the first two weeks of the clinical practice period, all students were supervised traditionally. Thereafter, the intervention group received peer learning the last two weeks, and the comparison group received traditional supervision. Questionnaire data were collected on nursing students' self-rated performance during the second (baseline) and last (follow-up) week of their clinical practice. Self-efficacy was improved in the intervention group and a significant interaction effect was found for changes over time between the two groups. For the other self-rated variables/tests, there were no differences in changes over time between the groups. Studying each group separately, the intervention group significantly improved on thirteen of the twenty variables/tests over time and the comparison group improved on four. The results indicate that peer learning is a useful method which improves nursing students' self-efficacy to a greater degree than traditional supervision does. Regarding the other self-rated performance variables, no interaction effects were found. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

[Personalized cell therapy for early postoperative bullous keratopathy (experimental proof and clinical results)].

PubMed

Kasparov, A A; Kasparova, Evg A; Fadeeva, L L; Subbot, A M; Borodina, N V; Kasparova, E A; Kobzova, M V; Musaeva, G M; Pavliuk, A S

2013-01-01

The article presents the results of a long-term research on development and clinical application of personalized cell therapy (PCT) for treatment of early postoperative (manifesting within the first 3 months after surgery) bullous keratopathy (BK). The method of intracameral PCT implies in vitro incubation of the patient's blood sample with poly(A:U) stimulator, separation of the serum with activated leukocytes, and injection of the final cell preparation into the anterior chamber. The fundamental part of the research was aimed at a detailed description of the cell preparation and investigation of its possible mechanisms of action. Cytokine and growth factor level in the cell preparation suggested that its high clinical efficacy might be due to its ability to improve regeneration of damaged corneal endothelium. The clinical study was conducted on a group of 52 patients with early BK. A significant effect (smoothing of the Descement's membrane folds, complete resorption of corneal edema, improvement of corneal transparency, reduction of corneal thickness and increase of visual acuity by 0.49 +/- 0.27) was achieved in 44.2% of patients, while partial effect was seen in 21.1% of patients. There was no clinical effect in 34.6% of patients. In those patients who developed significant or partial clinical effect after the PCT, many endotheliocytes appeared to have multiple nuclei (2 and more). In some patients polyploid nuclei persisted for 3-5 years after the treatment. Polyploidy results from incomplete mitosis which might be due to regenerative processes in the endothelium stimulated by the PCT. Obviously, high efficacy and relative simplicity of the method should promote its further clinical introduction.

Brief strategic therapy for obsessive-compulsive disorder: a clinical and research protocol of a one-group observational study.

PubMed

Pietrabissa, Giada; Manzoni, Gian Mauro; Gibson, Padraic; Boardman, Donald; Gori, Alessio; Castelnuovo, Gianluca

2016-03-24

Obsessive-compulsive disorder (OCD) is a disabling psychopathology. The mainstay of treatment includes cognitive-behavioural therapy (CBT) and medication management. However, individual suffering, functional impairments as well as the direct and indirect costs associated with the disease remain substantial. New treatment programmes are necessary and the brief strategic therapy (BST) has recently shown encouraging results in clinical practice but no quantitative study has as yet been conducted. The clinical effectiveness of the OCD-specific BST protocol will be evaluated in a one-group observational study. Participants will be sequentially recruited from a state community psychotherapy clinic in Dublin, Ireland. Outcome measures will be the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Beck Depression Inventory-II (BDI-II). Data will be collected at baseline, at treatment termination and at 3 month follow-up. The statistical significance of the post-treatment effect will be assessed by the paired-sample Student t test, while clinical significance will be evaluated by means of the equivalence testing method, which will be also used to assess the maintenance of effect at follow-up. The present study is approved by the Hesed House Ethics Board in Dublin. Findings will enhance the evidence-based knowledge about the clinical effectiveness of BST in treating OCD symptoms, prior to assessing its efficacy in a randomised and controlled clinical trial, and will be disseminated through publication in peer-reviewed journals and conference presentations. 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/

Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.

PubMed

Meropol, Neal J; Wong, Yu-Ning; Albrecht, Terrance; Manne, Sharon; Miller, Suzanne M; Flamm, Anne Lederman; Benson, Al Bowen; Buzaglo, Joanne; Collins, Michael; Egleston, Brian; Fleisher, Linda; Katz, Michael; Kinzy, Tyler G; Liu, Tasnuva M; Margevicius, Seunghee; Miller, Dawn M; Poole, David; Roach, Nancy; Ross, Eric; Schluchter, Mark D

2016-02-10

Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers. © 2015 by American Society of Clinical Oncology.

Clinical observation of lymphocyte active immunotherapy in 380 patients with unexplained recurrent spontaneous abortion.

PubMed

Chen, Jian-Ling; Yang, Jian-Ming; Huang, Ya-Zhe; Li, Ying

2016-11-01

This study aims to investigate the clinical curative effect of lymphocyte active immunotherapy (LAI) on unexplained recurrent spontaneous abortion (RSA). A total of 749 RSA patients who received medical service in our hospital from October 2009 to June 2013 were enrolled into this study. These patients were randomly divided into two groups: LAI group (treatment group) and routine progesterone for maintenance tocolysis group (control group). A comparative analysis on the pregnancy outcomes in these two groups was conducted. Abortion rate was significantly lower in the LAI group than in the control group (P<0.05). Furthermore, pregnancy success rates were 89.7% and 32.2% in patients who received LAI and routine progesterone for maintenance tocolysis, respectively, and the difference was statistically significant (P<0.05). Our analysis suggested that LAI can treat RSA effectively and has an excellent clinical effect. Furthermore, the detection of blocking antibodies showed a positive prediction on pregnancy outcome. Copyright © 2016 Elsevier B.V. All rights reserved.

Effects of ward rotation on subsequent transition processes of Japanese clinical nurses.

PubMed

Fujino, Mitsuku; Nojima, Yoshiko

2005-03-01

The purpose of this study was to examine the experience of Japanese clinical nurses undertaking a ward rotation in a general hospital, and its effects on subsequent processes relating to: (i) perception of ward rotation; (ii) reactions to the ward transition process; and (iii) outcomes of ward rotation. In-depth interviews were conducted with 21 Japanese clinical nurses who had an average of 8.8 years (SD = 5.50) clinical experience. Findings indicated that participants experienced role overload, role incongruity and/or role underload, role overqualification, or role ambiguity in the new environment. These role stresses created critical emotional distress during the transition process. The high desire for career development facilitated the transition process, while lack of preparation inhibited the transition process. To facilitate smooth transition, well-prepared and structured supports based on reliable interpersonal relationships are necessary. The findings offer significant cues for effective ward rotation programs. The implication for nursing administrators is that appropriate ward rotations enhance confidence and promote effective role development in the new clinical setting.

The problem of parental nonadherence in clinical behavior analysis: effective treatment is not enough.

PubMed Central

Allen, K D; Warzak, W J

2000-01-01

Applied behavior analysts have developed many effective interventions for common childhood problems and have repeatedly demonstrated that childhood behavior responds to properly managed contingencies. The success of these interventions is dependent upon their basic effectiveness, as demonstrated in the literature, their precise delivery by the clinician to the parent, and adherence to or consistent implementation of the intervention. Unfortunately, arranging the consistent implementation of effective parenting strategies is a significant challenge for behavior analysts who work in homes, schools, and outpatient or primary care clinics. Much has been done to address issues of adherence or implementation in the clinic, but relatively little has been done to increase our understanding of the contingencies that affect parental adherence beyond the supervised clinic environment. An analysis of the contingencies that strengthen or weaken adherence might suggest strategies to improve implementation outside the clinic setting. What follows is an analysis of the variables associated with adherence by parents to recommendations designed to solve common childhood problems. PMID:11051583

[Similarity of Clinically Significant Neuropsychiatric Adverse Reactions Listed in Package Inserts between the Anti-influenza Drugs Oseltamivir and Amantadine (Possibility Attributable to Common Pharmacological Effects)].

PubMed

Ono, Hideki; Okamura, Maya; Fukushima, Akihiro

2018-06-20

  The anti-influenza virus drug oseltamivir has been reported to have several pharmacological actions including blocking of nicotinic acetylcholine receptor channels and activation of the dopaminergic system. These pharmacological actions highly overlap those of amantadine, another anti-influenza virus drug authorized in Japan, and ester-type local anesthetics. Moreover, oseltamivir and amantadine can clinically induce similar adverse neuropsychiatric reactions. In the present study, from the database of the Pharmaceuticals and Medical Devices Agency (PMDA), we surveyed 2,576 drugs for which neuropsychiatric side effects similar to those of oseltamivir, amantadine and local anesthetics (abnormal behavior, confusion, consciousness disturbance, convulsion, delirium, delusion, hallucination, myoclonus, tremor) are listed as "clinically significant adverse reactions", and found 327 that had at least one of these adverse reactions. Other neuraminidase inhibitors (laninamivir, peramivir and zanamivir) did not elicit such adverse reactions. By discussing the pharmacological effects of drugs that elicit these adverse reactions, we propose that the similarity of adverse neuropsychiatric reactions between oseltamivir and amantadine is possibly attributable to their common pharmacological effects.

Comparison of the clinical effects of white brand toothbrushes versus Vitis Suave®

PubMed Central

Segarra-Vidal, Marta; Lucas-Alcahuz, Eduardo; López-Roldán, Andrés; Gil-Loscos, Francisco; Alpiste-Illueca, Francisco

2015-01-01

Background There has been an increase in the use of white label manual toothbrushes and a greater increase in inquiries for discomfort of the gingiva and mucosa. Material and Methods A randomized, double-blind, cross-over clinical trial was made of four white brand toothbrushes versus a control brush (Vitis Suave®), with the recording of plaque index, bleeding upon probing, and gingival abrasions following utilization of the different brushes. Results All the brushes except Deliplus® were equally effective in terms of plaque removal (p<0.05). Vitis Suave® and Veckia® were the brushes associated to the greatest increase in minor abrasions (p<0.01), while Veckia®, Carrefour® and Deluxe® significantly increased the number of medium intensity abrasions (p<0.05). These brushes also increased the number of large abrasions, though statistical significance was not reached in this case. Conclusions The white brand brushes proved effective in controlling bacterial plaque, but were associated to more intense soft tissue abrasion. Key words:Gingival abrasions, manual tooth brushing, white brand, clinical effects. PMID:26535095

The clinical efficacy of dietary fat restriction in treatment of dogs with intestinal lymphangiectasia.

PubMed

Okanishi, H; Yoshioka, R; Kagawa, Y; Watari, T

2014-01-01

Intestinal lymphangiectasia (IL), a type of protein-losing enteropathy (PLE), is a dilatation of lymphatic vessels within the gastrointestinal tract. Dietary fat restriction previously has been proposed as an effective treatment for dogs with PLE, but limited objective clinical data are available on the efficacy of this treatment. To investigate the clinical efficacy of dietary fat restriction in dogs with IL that were unresponsive to prednisolone treatment or showed relapse of clinical signs and hypoalbuminemia when the prednisolone dosage was decreased. Twenty-four dogs with IL. Retrospective study. Body weight, clinical activity score, and hematologic and biochemical variables were compared before and 1 and 2 months after treatment. Furthermore, the data were compared between the group fed only an ultra low-fat (ULF) diet and the group fed ULF and a low-fat (LF) diet. Nineteen of 24 (79%) dogs responded satisfactorily to dietary fat restriction, and the prednisolone dosage could be decreased. Clinical activity score was significantly decreased after dietary treatment compared with before treatment. In addition, albumin (ALB), total protein (TP), and blood urea nitrogen (BUN) concentration were significantly increased after dietary fat restriction. At 2 months posttreatment, the ALB concentrations in the ULF group were significantly higher than that of the ULF + LF group. Dietary fat restriction appears to be an effective treatment in dogs with IL that are unresponsive to prednisolone treatment or that have recurrent clinical signs and hypoalbuminemia when the dosage of prednisolone is decreased. © 2014 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of American College of Veterinary Internal Medicine.

Effect of local endometrial injury on pregnancy outcomes in ovum donation cycles.

PubMed

Dain, Lena; Ojha, Kamal; Bider, David; Levron, Jacob; Zinchenko, Viktor; Walster, Sharon; Dirnfeld, Martha

2014-10-01

To evaluate the effect of local endometrial injury (LEI) on clinical outcomes in ovum donation recipients. Retrospective cohort analysis of ovum donation cycles conducted from 2005 to 2012. Two private IVF centers. Total 737 ovum donation cycles. LEI by endometrial "scratch" with the use of a Pipelle catheter. Clinical pregnancy and live birth rates. No statistically significant differences were found in clinical pregnancy rates and live birth rates in cycles subjected to LEI compared with those without. Combination of LEI with fibroid uterus resulted with significantly higher clinical pregnancy rates compared with LEI in normal uterine anatomy. This is the first study done in ovum recipients who underwent LEI by a "scratch" procedure after failed implantation. Unlike most previous reports, which found improved pregnancy rates with the use of "scratch effect" or "minor endometrial injury" after repeated implantation failures in standard IVF with own eggs, we did not find any changes in implantation rates in a population of egg recipients following this procedure. In view of a possible positive effect of LEI in cycles with a previous four or more failures, prospective randomized controlled studies are warranted to better define the target population who may benefit from this intervention. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Improvement of autonomic nervous regulation by blood purification therapy using acetate-free dialysis fluid - clinical evaluation by laser Doppler flowmetry.

PubMed

Sato, Takashi; Taoka, Masahiro; Miyahara, Takaaki

2011-01-01

In Japan, acetate-free biofiltration (AFBF) became commercially available in the year 2000, and these products have been reported to be clinically effective for controlling the decrease of blood pressure during dialysis or various types of dialysis intolerance. And more, acetate-free dialysis fluid was made clinically available in 2007, acetate-free hemodialysis (AFHD) is expected to inhibit the malnutrition-inflammation-atherosclerosis syndrome, improve anemia and the nutritional status of patients, stabilize hemodynamics, and reduce inflammation and oxidative stress. In a broad sense, AFBF can be classified as hemodiafiltration (HDF), and its clinical effects seem to be associated with multiple factors, including use of acetate-free dialysis fluid, massive removal of low molecular weight proteins by convection, and the sodium concentration of the replacement fluid. Therefore, the clinical significance of acetate-free dialysis fluid could be demonstrated more clearly by comparing AFHD with conventional hemodialysis (conv. HD) using dialysis fluid containing about 10 mEq/l acetate. Since 2005, we have been investigating the efficacy of various modalities of blood purification therapy by continuously monitoring changes of tissue blood flow in the lower limbs and earlobes (head) using non-invasive continuous monitoring method (NICOMM). In this report, we assess the clinical effectiveness of AFHD on the basis of clinical findings and head stability index (head SI) obtained by NICOMM, particularly with respect to the influence on autonomic regulation. After switching to AFHD from conv. HD, anemia, stored iron utilization, and the frequency of treatments for dialysis hypotension and of muscle cramps were significantly improved. Further, the head SI was also significantly smaller with AFHD than conv. HD. This finding suggests that AFHD improved the maintenance of homeostasis by the autonomic nervous regulation system. In addition, we could not find clinical features of excessive alkalosis during an observation period of about 1 year, even if online HDF using acetate-free dialysis fluid as the substitution fluid. Our conclusion is that the advent of acetate-free dialysis fluid has led to investigations into new clinical effectiveness of AFHD or online HDF/HF using ultrapurified acetate-free dialysis fluid as the substitution fluid. Copyright © 2011 S. Karger AG, Basel.

Molecular basis of the potential of vitamin D to prevent cancer.

PubMed

Ingraham, Betty A; Bragdon, Beth; Nohe, Anja

2008-01-01

To review current research findings in cell biology, epidemiology, preclinical, and clinical trials on the protective effects of vitamin D against the development of cancers of the breast, colon, prostate, lung, and ovary. Current recommendations for optimal vitamin D status, the movement towards revision of standards, and reflections on healthy exposure to sunlight are also reviewed. Search methodology: A literature search was conducted in April and updated in September 2007. The Medline and Web of Knowledge databases were searched for primary and review articles published between 1970 and 2007, using the search terms 'vitamin D', 'calcitriol', 'cancer', 'chemoprevention', 'nuclear receptor', 'vitamin D receptor', 'apoptosis', 'cell cycle', 'epidemiology', and 'cell adhesion molecule'. Articles that focused on epidemiological, preclinical, and clinical evidence for vitamin D's effects were selected and additional articles were obtained from reference lists of the retrieved articles. An increasing body of research supports the hypothesis that the active form of vitamin D has significant, protective effects against the development of cancer. Epidemiological studies show an inverse association between sun exposure, serum levels of 25(OH)D, and intakes of vitamin D and risk of developing and/or surviving cancer. The protective effects of vitamin D result from its role as a nuclear transcription factor that regulates cell growth, differentiation, apoptosis and a wide range of cellular mechanisms central to the development of cancer. A significant number of individuals have serum vitamin D levels lower than what appears to protect against cancer, and the research community is currently revising the guidelines for optimal health. This will lead to improved public health policies and to reduced risk of cancer. Research strongly supports the view that efforts to improve vitamin D status would have significant protective effects against the development of cancer. The clinical research community is currently revising recommendations for optimal serum levels and for sensible levels of sun exposure, to levels greater than previously thought. Currently, most experts in the field believe that intakes of between 1000 and 4000 IU will lead to a more healthy level of serum 25(OH)D, at approximately 75 nmol/L that will offer significant protection effects against cancers of the breast, colon, prostate, ovary, lungs, and pancreas. The first randomized trial has shown significant protection against breast cancer, and other clinical trials will follow and ultimately lead to improved public health policies and significantly fewer cancers.

Evaluation of chest tomosynthesis for the detection of pulmonary nodules: effect of clinical experience and comparison with chest radiography

NASA Astrophysics Data System (ADS)

Zachrisson, Sara; Vikgren, Jenny; Svalkvist, Angelica; Johnsson, Åse A.; Boijsen, Marianne; Flinck, Agneta; Månsson, Lars Gunnar; Kheddache, Susanne; Båth, Magnus

2009-02-01

Chest tomosynthesis refers to the technique of collecting low-dose projections of the chest at different angles and using these projections to reconstruct section images of the chest. In this study, a comparison of chest tomosynthesis and chest radiography in the detection of pulmonary nodules was performed and the effect of clinical experience of chest tomosynthesis was evaluated. Three senior thoracic radiologists, with more than ten years of experience of chest radiology and 6 months of clinical experience of chest tomosynthesis, acted as observers in a jackknife free-response receiver operating characteristics (JAFROC-1) study, performed on 42 patients with and 47 patients without pulmonary nodules examined with both chest tomosynthesis and chest radiography. MDCT was used as reference and the total number of nodules found using MDCT was 131. To investigate the effect of additional clinical experience of chest tomosynthesis, a second reading session of the tomosynthesis images was performed one year after the initial one. The JAFROC-1 figure of merit (FOM) was used as the principal measure of detectability. In comparison with chest radiography, chest tomosynthesis performed significantly better with regard to detectability. The observer-averaged JAFROC-1 FOM was 0.61 for tomosynthesis and 0.40 for radiography, giving a statistically significant difference between the techniques of 0.21 (p<0.0001). The observer-averaged JAFROC-1 FOM of the second reading of the tomosynthesis cases was not significantly higher than that of the first reading, indicating no improvement in detectability due to additional clinical experience of tomosynthesis.

Clinical and radiographic comparison of the effects of two types of fixed retainers on periodontium - a randomized clinical trial.

PubMed

Torkan, Sepideh; Oshagh, Morteza; Khojastepour, Leila; Shahidi, Shoaleh; Heidari, Somayeh

2014-08-27

Most orthodontists believe that fixed retainers are necessary to maintain ideal dental relationships. However, untoward side effects might result from their long-term placement. The aim of this study was to evaluate the clinical and radiographic effect of two commonly used fixed retainers on the health of the periodontium. Thirty patients were randomly divided into two groups to receive either a fiber-reinforced composite retainer or a spiral wire retainer extended on the lingual surfaces of both maxillary and mandibular arches from canine to canine. Periapical radiographs were obtained from the patients at the time of placement of the retainers and after the 6-month period to assess the radiographic conditions of the periodontium. Clinical examination was carried out at the same two time intervals. Even though there were no significant differences between the two groups of study at the beginning of the trial, there were statistically significant differences after the 6-month follow-up regarding the main outcomes of the study. Nearly all indices showed to deteriorate after 6 months in the fiber-reinforced group, while in the spiral wire group, this was not the case. As for the secondary outcomes, radiographic examination did not reveal any statistically significant differences after 6 months or between the two groups. It can be concluded that spiral wire retainers elicit less detrimental periodontal response in the short-term follow-up compared to fiber-reinforced composite retainers as revealed by the primary outcomes of the study. ClinicalTrials.gov: NCT01314729.

Randomized and controlled clinical study of modified prescriptions of Simiao Pill in the treatment of acute gouty arthritis.

PubMed

Shi, Xin-de; Li, Guo-chun; Qian, Zu-xi; Jin, Ze-qiu; Song, Yan

2008-03-01

To investigate the compatibility of a modified prescription of Simiao Pill in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. A randomized and controlled clinical trial was designed based on clinical epidemiological principles. A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group I) included 27 patients taking gout prescription I; the second group (Group II) included 27 patients taking gout prescription II; the third group (Group III) included 28 patients taking gout prescription III; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured. The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%, significantly superior to that of the control group (68%, P<0.05). In terms of the improvement of main symptoms, the scores of four symptoms in all TCM treatment and control groups decreased after treatment, with statistically significant differences (P<0.05). Moreover, the scores markedly fell more so in the three Chinese herb groups than in the control group, and especially in Group III (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen. The modified prescriptions, based on the clinical research, clinical experience and traditional Chinese medicine theory, did show a better effect than Western medicine in this clinical study. Moreover, the prescriptions were precise, with the herbs inexpensive and readily available. The patients had good compliance with less adverse reactions noted. The modified prescription has a favorable prospect for future development and is worthy of further blind trials with larger samples.

Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial

PubMed Central

Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

2016-01-01

[Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists. PMID:27134355

Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial.

PubMed

Küçük, Fadime; Kara, Bilge; Poyraz, Esra Çoşkuner; İdiman, Egemen

2016-03-01

[Purpose] The aim of this study was to determine the effects of clinical Pilates in multiple sclerosis patients. [Subjects and Methods] Twenty multiple sclerosis patients were enrolled in this study. The participants were divided into two groups as the clinical Pilates and control groups. Cognition (Multiple Sclerosis Functional Composite), balance (Berg Balance Scale), physical performance (timed performance tests, Timed up and go test), tiredness (Modified Fatigue Impact scale), depression (Beck Depression Inventory), and quality of life (Multiple Sclerosis International Quality of Life Questionnaire) were measured before and after treatment in all participants. [Results] There were statistically significant differences in balance, timed performance, tiredness and Multiple Sclerosis Functional Composite tests between before and after treatment in the clinical Pilates group. We also found significant differences in timed performance tests, the Timed up and go test and the Multiple Sclerosis Functional Composite between before and after treatment in the control group. According to the difference analyses, there were significant differences in Multiple Sclerosis Functional Composite and Multiple Sclerosis International Quality of Life Questionnaire scores between the two groups in favor of the clinical Pilates group. There were statistically significant clinical differences in favor of the clinical Pilates group in comparison of measurements between the groups. Clinical Pilates improved cognitive functions and quality of life compared with traditional exercise. [Conclusion] In Multiple Sclerosis treatment, clinical Pilates should be used as a holistic approach by physical therapists.

Clinical Significance of the Number of Depressive Symptoms in Major Depressive Disorder: Results from the CRESCEND Study.

PubMed

Park, Seon-Cheol; Sakong, Jeongkyu; Koo, Bon Hoon; Kim, Jae-Min; Jun, Tae-Youn; Lee, Min-Soo; Kim, Jung-Bum; Yim, Hyeon-Woo; Park, Yong Chon

2016-04-01

Our study aimed to establish the relationship between the number of depressive symptoms and the clinical characteristics of major depressive disorder (MDD). This would enable us to predict the clinical significance of the number of depressive symptoms in MDD patients. Using data from the Clinical Research Center for Depression (CRESCEND) study in Korea, 853 patients with DSM-IV MDD were recruited. The baseline and clinical characteristics of groups with different numbers of depressive symptoms were compared using the χ(2) test for discrete variables and covariance (ANCOVA) for continuous variables. In addition, the scores of these groups on the measurement tools were compared by ANCOVA after adjusting the potential effects of confounding variables. After adjusting the effects of monthly income and history of depression, a larger number of depressive symptoms indicated higher overall severity of depression (F [4, 756] = 21.458, P < 0.001) and higher levels of depressive symptoms (F [4, 767] = 19.145, P < 0.001), anxiety symptoms (F [4, 765] = 12.890, P < 0.001) and suicidal ideation (F [4, 653] = 6.970, P < 0.001). It also indicated lower levels of social function (F [4, 760] = 13.343, P < 0.001), and quality of life (F [4, 656] = 11.975, P < 0.001). However, there were no significant differences in alcohol consumption (F [4, 656] = 11.975, P < 0.001). The number of depressive symptoms can be used as an index of greater illness burden in clinical psychiatry.

Genetics and the Placebo Effect: the Placebome

PubMed Central

Hall, Kathryn T.; Loscalzo, Joseph; Kaptchuk, Ted J.

2015-01-01

Placebos are indispensable controls in randomized clinical trials (RCTs), and placebo responses significantly contribute to routine clinical outcomes. Recent neurophysiological studies reveal neurotransmitter pathways that mediate placebo effects. Evidence that genetic variations in these pathways can modify placebo effects raises the possibility of using genetic screening to identify placebo responders and thereby increase RCT efficacy and improve therapeutic care. Furthermore, the possibility of interaction between placebo and drug molecular pathways warrants consideration in RCT design. The study of genomic effects on placebo response, “the placebome”, is in its infancy. Here, we review evidence from placebo studies and RCTs to identify putative genes in the placebome, examine evidence for placebo-drug interactions, and discuss implications for RCTs and clinical care. PMID:25883069

Does a Rater's Professional Background Influence Communication Skills Assessment?

PubMed

Artemiou, Elpida; Hecker, Kent G; Adams, Cindy L; Coe, Jason B

2015-01-01

There is increasing pressure in veterinary education to teach and assess communication skills, with the Objective Structured Clinical Examination (OSCE) being the most common assessment method. Previous research reveals that raters are a large source of variance in OSCEs. This study focused on examining the effect of raters' professional background as a source of variance when assessing students' communication skills. Twenty-three raters were categorized according to their professional background: clinical sciences (n=11), basic sciences (n=4), clinical communication (n=5), or hospital administrator/clinical skills technicians (n=3). Raters from each professional background were assigned to the same station and assessed the same students during two four-station OSCEs. Students were in year 2 of their pre-clinical program. Repeated-measures ANOVA results showed that OSCE scores awarded by the rater groups differed significantly: (F(matched_station_1) [2,91]=6.97, p=.002), (F(matched_station_2) [3,90]=13.95, p=.001), (F(matched_station_3) [3,90]=8.76, p=.001), and ((Fmatched_station_4) [2,91]=30.60, p=.001). A significant time effect between the two OSCEs was calculated for matched stations 1, 2, and 4, indicating improved student performances. Raters with a clinical communication skills background assigned scores that were significantly lower compared to the other rater groups. Analysis of written feedback provided by the clinical sciences raters showed that they were influenced by the students' clinical knowledge of the case and that they did not rely solely on the communication checklist items. This study shows that it is important to consider rater background both in recruitment and training programs for communication skills' assessment.

Influence of clinical mastitis and its treatment outcome on reproductive performance in crossbred cows: A retrospective study

PubMed Central

Kumar, Narender; Manimaran, A.; Sivaram, M.; Kumaresan, A.; Jeyakumar, S.; Sreela, L.; Mooventhan, P.; Rajendran, D.

2017-01-01

Aim: Evaluation of the effect of clinical mastitis (CM) and its treatment outcome on the reproductive performance in crossbred cows retrospectively. Materials and Methods: Datasets of 835 lactating cows affected with CM during a period of 12 years (2001-2012) were considered for this study. Mastitis treatment related data and reproductive parameters such as days to first detected heat (DTFDH), days to first insemination (DTFI), days open (DO), and number of services per conception (SC) were collected from mastitis treatment and artificial insemination registers, respectively. Data were analyzed by ANOVA using SPSS 20 software. The means were compared with the Duncan’s multiple comparison post-hoc test. Results: CM affected cows had significantly (p<0.05) higher DTFDH, DTFI, DO and SC compared to clinically healthy cows. Cows diagnosed with a single episode of CM had significantly (p<0.05) delayed DTFDH while, DO and SC were significantly higher (p<0.05) in cows diagnosed by multiple episodes of CM. SC was significantly (p<0.05) higher in cows diagnosed with both relapse and recurrence. Severe CM affected cows had significantly (p<0.05) altered reproductive parameters. The reproductive parameters were altered to high extent when CM occurred during the breeding period. Conclusion: CM-affected cows had higher DTFDH, DTFI, DO and SC compared to clinically healthy cows. The negative effects of CM on reproduction parameters were higher when CM occurred during the breeding period. PMID:28620250

Once-daily USL255 as adjunctive treatment of partial-onset seizures: Randomized phase III study

PubMed Central

Chung, Steve S; Fakhoury, Toufic A; Hogan, R Edward; Nagaraddi, Venkatesh N; Blatt, Ilan; Lawson, Balduin; Arnold, Stephan; Anders, Bob; Clark, Annie M; Laine, Dawn; Meadows, R Shawn; Halvorsen, Mark B

2014-01-01

Objective To evaluate the efficacy and safety of USL255, Qudexy™ XR (topiramate) extended-release capsules, as an adjunctive treatment for refractory partial-onset seizures (POS) in adults taking one to three concomitant antiepileptic drugs. Methods In this global phase III study (PREVAIL; NCT01142193), 249 adults with POS were randomized 1:1 to once-daily USL255 (200 mg/day) or placebo. The primary and key secondary efficacy endpoints were median percent reduction in weekly POS frequency and responder rate (proportion of patients with ≥50% reduction in seizure frequency). Seizure freedom was also assessed. Safety (adverse events, clinical and laboratory findings), as well as treatment effects on quality of life (QOLIE-31-P) and clinical global impression of change (CGI-C), were evaluated. Results Across the entire 11-week treatment phase, USL255 significantly reduced the median percent seizure frequency and significantly improved responder rate compared with placebo. Efficacy over placebo was observed early in treatment, in patients with highly refractory POS, and in those with the most debilitating seizure types (i.e., complex partial, partial secondarily generalized). USL255 was safe and generally well tolerated with a low incidence of neurocognitive adverse events. USL255 was associated with significant clinical improvement without adversely affecting quality of life. Significance The PREVAIL phase III clinical study demonstrated that once-daily USL255 (200 mg/day) significantly improved seizure control and was safe and generally well tolerated with few neurocognitive side effects. PMID:24902983

Comparison of clinical and survival characteristics between prostate cancer patients of PSA-based screening and clinical diagnosis in China.

PubMed

Xu, Libo; Wang, Jinguo; Guo, Baofeng; Zhang, Haixia; Wang, Kaichen; Wang, Ding; Dai, Chang; Zhang, Ling; Zhao, Xuejian

2018-01-02

Prostate-specific antigen (PSA)-based mass screening remains the most controversial topic in prostate cancer. PSA-based mass screening has not been widely used in China yet. The aim of our study was to evaluate the effect of the PSA-based screening in China. The cohort consisted of 1,012 prostate cancer patients. Data were retrospectively collected and clinical characteristics of the cohorts were investigated. Survival was analyzed for prostatic carcinoma of both PSA screened and clinically diagnosed patients according to clinical characteristics and the National Comprehensive Cancer Network (NCCN) risk classification. Cox Proportional Hazards Model analysis was done for risk predictor identification. The median age was 71 years old. Five-year overall and prostate-cancer-specific survival in prostatic adenocarcinoma patients were 77.52% and 79.65%; 10-year survivals were 62.57% and 68.60%, respectively. Survival was significantly poorer in patients with metastases and non-curative management. T staging and Gleason score by NCCN classification effectively stratified prostatic adenocarcinoma patients into different risk groups. T staging was a significant predictor of survival by COX Proportional Hazard Model. PSA screened patients had a significantly higher percentage diagnosed in early stage. PSA screened prostatic adenocarcinoma patients had a better prognosis in both overall and prostate cancer-specific survivals. This Chinese cohort had a lower overall and prostate cancer survival rate than it is reported in western countries. The incidence of early-stage prostate cancer found in PSA-based mass screening was high and there were significant differences in both overall and prostate cancer-specific survival between the PSA-screened and clinically diagnosed patients.

Comparison of clinical and survival characteristics between prostate cancer patients of PSA-based screening and clinical diagnosis in China

PubMed Central

Xu, Libo; Wang, Jinguo; Guo, Baofeng; Zhang, Haixia; Wang, Kaichen; Wang, Ding; Dai, Chang; Zhang, Ling; Zhao, Xuejian

2018-01-01

Prostate-specific antigen (PSA)-based mass screening remains the most controversial topic in prostate cancer. PSA-based mass screening has not been widely used in China yet. The aim of our study was to evaluate the effect of the PSA-based screening in China. The cohort consisted of 1,012 prostate cancer patients. Data were retrospectively collected and clinical characteristics of the cohorts were investigated. Survival was analyzed for prostatic carcinoma of both PSA screened and clinically diagnosed patients according to clinical characteristics and the National Comprehensive Cancer Network (NCCN) risk classification. Cox Proportional Hazards Model analysis was done for risk predictor identification. The median age was 71 years old. Five-year overall and prostate-cancer-specific survival in prostatic adenocarcinoma patients were 77.52% and 79.65%; 10-year survivals were 62.57% and 68.60%, respectively. Survival was significantly poorer in patients with metastases and non-curative management. T staging and Gleason score by NCCN classification effectively stratified prostatic adenocarcinoma patients into different risk groups. T staging was a significant predictor of survival by COX Proportional Hazard Model. PSA screened patients had a significantly higher percentage diagnosed in early stage. PSA screened prostatic adenocarcinoma patients had a better prognosis in both overall and prostate cancer-specific survivals. This Chinese cohort had a lower overall and prostate cancer survival rate than it is reported in western countries. The incidence of early-stage prostate cancer found in PSA-based mass screening was high and there were significant differences in both overall and prostate cancer-specific survival between the PSA-screened and clinically diagnosed patients. PMID:29416625

New scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) in clinical trials.

PubMed

Verma, Nishant; Beretvas, S Natasha; Pascual, Belen; Masdeu, Joseph C; Markey, Mia K

2015-11-12

As currently used, the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) has low sensitivity for measuring Alzheimer's disease progression in clinical trials. A major reason behind the low sensitivity is its sub-optimal scoring methodology, which can be improved to obtain better sensitivity. Using item response theory, we developed a new scoring methodology (ADAS-CogIRT) for the ADAS-Cog, which addresses several major limitations of the current scoring methodology. The sensitivity of the ADAS-CogIRT methodology was evaluated using clinical trial simulations as well as a negative clinical trial, which had shown an evidence of a treatment effect. The ADAS-Cog was found to measure impairment in three cognitive domains of memory, language, and praxis. The ADAS-CogIRT methodology required significantly fewer patients and shorter trial durations as compared to the current scoring methodology when both were evaluated in simulated clinical trials. When validated on data from a real clinical trial, the ADAS-CogIRT methodology had higher sensitivity than the current scoring methodology in detecting the treatment effect. The proposed scoring methodology significantly improves the sensitivity of the ADAS-Cog in measuring progression of cognitive impairment in clinical trials focused in the mild-to-moderate Alzheimer's disease stage. This provides a boost to the efficiency of clinical trials requiring fewer patients and shorter durations for investigating disease-modifying treatments.

A Quasi-Experimental Study Examining New York State's Tobacco-Free Regulation: Effects on Clinical Practice Behaviors

PubMed Central

Laschober, Tanja C.

2013-01-01

Background On July 24, 2008, New York State (NYS) became the first state to require all state-funded or state-certified substance use disorder (SUD) treatment organizations to be 100% tobacco-free and offer tobacco cessation (TC) treatment. Methods The current study used a quasi-experimental, non-equivalent control group design with a pretest and posttest to examine the effect of the NYS tobacco-free regulation on three clinical practice behaviors (use of TC-related intake procedures, use of guideline recommended counseling for TC, and pharmacotherapy availability) in a diverse sample of SUD treatment programs. Repeated cross-sectional data were collected from NYS counselors (experimental group) and non-NYS counselors (control group) approximately 4 months pre-regulation (N = 282 and 659, respectively) and 10-12 months post-regulation (N = 364 and 733, respectively). Results Using mixed-effects models, results at pre-regulation indicate no group differences in the three clinical practice behaviors. However, significant post-regulation effects were found such that the experimental group reports greater use of TC-related intake procedures, guideline recommended counseling, and availability of pharmacotherapy than the control group. Additionally, the experimental but not the control group shows increases in all three clinical practice behaviors from pre-regulation to post-regulation. Conclusions We conclude that the NYS tobacco-free regulation had a significant and positive effect on promoting patient TC efforts among counselors. PMID:23428317

The effect of grapefruits (Citrus paradisi) on body weight and cardiovascular risk factors: A systematic review and meta-analysis of randomized clinical trials.

PubMed

Onakpoya, Igho; O'Sullivan, Jack; Heneghan, Carl; Thompson, Matthew

2017-02-11

The aim of this systematic review was to evaluate the evidence for or against the effectiveness of grapefruits (Citrus paradisi) on body weight, blood pressure, and lipid profile. Electronic searches were conducted in MEDLINE, EMBASE, AMED, and the Cochrane Clinical Trials databases to identify relevant human randomized clinical trials (RCTs). Hand searches of bibliographies were also conducted. Only overweight and obese subjects were included. The reporting quality was assessed using the CONSORT checklist, and the strength of the overall body of evidence was rated based on the GRADE criteria. One hundred and fifty four citations were identified and three RCTs with a total of 250 participants were included. The RCTs were of moderate quality. A meta-analysis for change in body weight failed to reveal a significant difference between grapefruits and controls, MD: -0.45 kg (95% CI: -1.06 to 0.16; I 2 = 53%, but analysis revealed a significant decrease in systolic blood pressure, MD: -2.43 mmHg (95% CI: -4.77 to -0.09; I 2 = 0%). Paucity in the number of RCTs, short durations of interventions, and lack of an established minimum effective dose limit the conclusions that can be drawn about the effects of grapefruit on body weight and metabolic parameters. Further clinical trials evaluating the effects of grapefruit are warranted.

Comparison of the Efficacy, Side Effects, and Cost of Modafinil and Intranasal Mometasone Furoate in Obstructive Sleep Apnea-Hypopnea Syndrome: A Preliminary Clinical Study

PubMed Central

Zhang, Shujia; Duan, Zhongnin

2018-01-01

Background Obstructive sleep apnea-hypopnea syndrome (OSAHS) is characterized by repeated episodes of reduction in airflow due to the collapse of the upper airway during sleep. The aim of this study was to compare clinical outcome, side effects, and cost of treatment between modafinil and intranasal mometasone furoate in patients with OSAHS. Material/Methods Patients with OSAHS (N=250) were divided into two groups: the modafinil group (MG) (N=125) were treated with 100 mg modafinil twice a day; the intranasal mometasone furoate group (IMFG) (N=125) were treated with 100 μg of intranasal mometasone furoate in the evening. Quality of life, grading of OSAHS, plain-film radiography, the adenoidal-nasopharyngeal ratio (AN ratio), side effects, cost of treatment, and beneficial effects after discontinuation of treatment were evaluated for all patients. Results Duration of sleep apnea was significantly reduced in the IMFG compared with the MG (p=0.0145, q=9.262). Modafinil and intranasal mometasone furoate both had moderate effects on improvement of the OSAHS score. The IMFG showed a significantly greater beneficial effect on the AN ratio when compared with the MG (p=0.0001, q=6.584). No adverse events of treatment with modafinil and intranasal mometasone furoate were reported. Cost of treatment and beneficial effect after discontinuation were both significantly greater for the IMFG compared with the MG. Conclusions The findings of this preliminary clinical study were that for patients diagnosed with OSAHS, night-time treatment with intranasal mometasone furoate was more effective than modafinil. PMID:29749371

Different frequencies and effects of ABCB1 T3435C polymorphism on clinical and laboratory features of B cell chronic lymphocytic leukemia in Kurdish patients.

PubMed

Maroofi, Farzad; Amini, Sabrieh; Roshani, Daem; Ghaderi, Bayazid; Abdi, Mohammad

2015-04-01

Finding the effects of gene polymorphism on cancer pathogenesis is very desirable. The ATP-binding cassette is involved in drug metabolism, and the polymorphism of this gene may be an important risk factor in B cell chronic lymphocytic leukemia (B-CLL) or progression and/or response to chemotherapy agents. For the first time, the present study was aimed to evaluate the probable effects of ABCB1 T3435C polymorphism on clinical and laboratory features of Kurdish patients with B-CLL. This descriptive analytical case-control study was performed on 50 B-CLL patients and 100 healthy subjects. Serum levels of beta-2-microglobulin (B2M) and lactate dehydrogenase (LDH) and blood WBC, RBC, Plt and ESR were measured. The T3435C polymorphism of the ABCB1 gene was determined by PCR-RFLP. Concentration of serum and blood markers was significantly higher in the malignant group than in the benign subjects. The CC genotype had the highest frequency (66%) in the patient groups. There are no significant differences between the genotypes and type of treatment. Our results demonstrate the high frequency of C allele of ABCB1 T3435C in B-CLL patients with Kurdish ethnicity. We also show that this polymorphism has a significant risk factor in B-CLL. However, the effect of this polymorphism on clinical and laboratory characteristics of B-CLL patients was not significant.

Promoting positive condom use experiences among young black MSM: a randomized controlled trial of a brief, clinic-based intervention.

PubMed

Crosby, Richard A; Mena, Leandro; Smith, Rachel Vickers

2018-06-01

The aim of this study is to determine, among young Black men who have sex with men (YBMSM), the 12-month efficacy of a single-session, clinic-based intervention promoting condom use to enhance sexual pleasure (purpose 1) and the use of condoms from the start-to-finish of anal sex (purpose 2). A pre-test, post-test randomized controlled trial was conducted, using a 12-month period of follow-up observation, in STI clinics. Data from 394 YBMSM completing baseline and 12-month follow-up assessments were analyzed. The experimental condition comprised a one-to-one, interactive program (Focus on the Future) designed for tailored delivery. Regarding study purpose 1, in an age-adjusted linear regression model for 277 HIV-uninfected men, there was a significant effect of the intervention (Beta=0.13, P =0.036) relative to more favorable sexual experiences when using condoms. Regarding study purpose 2, in an adjusted logistic regression model, for HIV-uninfected men, there was a significant effect of the intervention (AOR=0.54, P =0.048) relative to using condoms from start-to-finish of anal sex. Significant effects for HIV-infected men were not observed. A small, but non-significant, effect was observed relative to men's self-report of always using condoms. This single-session program may be a valuable counseling tool for use in conjunction with pre-exposure prophylaxis-related care for HIV-uninfected YBMSM.

Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia.

PubMed

Sil, Soumitri; Arnold, Lesley M; Lynch-Jordan, Anne; Ting, Tracy V; Peugh, James; Cunningham, Natoshia; Powers, Scott W; Lovell, Daniel J; Hashkes, Philip J; Passo, Murray; Schikler, Kenneth N; Kashikar-Zuck, Susmita

2014-07-01

The primary objective of this study was to estimate a clinically significant and quantifiable change in functional disability to identify treatment responders in a clinical trial of cognitive-behavioral therapy (CBT) for youth with juvenile fibromyalgia (JFM). The second objective was to examine whether baseline functional disability (Functional Disability Inventory), pain intensity, depressive symptoms (Children's Depression Inventory), coping self-efficacy (Pain Coping Questionnaire), and parental pain history predicted treatment response in disability at 6-month follow-up. Participants were 100 adolescents (11-18 years of age) with JFM enrolled in a recently published clinical trial comparing CBT to a fibromyalgia education (FE) intervention. Patients were identified as achieving a clinically significant change in disability (i.e., were considered treatment responders) if they achieved both a reliable magnitude of change (estimated as a > or = 7.8-point reduction on the FDI) using the Reliable Change Index, and a reduction in FDI disability grade based on established clinical reference points. Using this rigorous standard, 40% of patients who received CBT (20 of 50) were identified as treatment responders, compared to 28% who received FE (14 of 50). For CBT, patients with greater initial disability and higher coping efficacy were significantly more likely to achieve a clinically significant improvement in functioning. Pain intensity, depressive symptoms, and parent pain history did not significantly predict treatment response. Estimating clinically significant change for outcome measures in behavioral trials sets a high bar but is a potentially valuable approach to improve the quality of clinical trials, to enhance interpretability of treatment effects, and to challenge researchers to develop more potent and tailored interventions. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Distinguishing between statistical significance and practical/clinical meaningfulness using statistical inference.

PubMed

Wilkinson, Michael

2014-03-01

Decisions about support for predictions of theories in light of data are made using statistical inference. The dominant approach in sport and exercise science is the Neyman-Pearson (N-P) significance-testing approach. When applied correctly it provides a reliable procedure for making dichotomous decisions for accepting or rejecting zero-effect null hypotheses with known and controlled long-run error rates. Type I and type II error rates must be specified in advance and the latter controlled by conducting an a priori sample size calculation. The N-P approach does not provide the probability of hypotheses or indicate the strength of support for hypotheses in light of data, yet many scientists believe it does. Outcomes of analyses allow conclusions only about the existence of non-zero effects, and provide no information about the likely size of true effects or their practical/clinical value. Bayesian inference can show how much support data provide for different hypotheses, and how personal convictions should be altered in light of data, but the approach is complicated by formulating probability distributions about prior subjective estimates of population effects. A pragmatic solution is magnitude-based inference, which allows scientists to estimate the true magnitude of population effects and how likely they are to exceed an effect magnitude of practical/clinical importance, thereby integrating elements of subjective Bayesian-style thinking. While this approach is gaining acceptance, progress might be hastened if scientists appreciate the shortcomings of traditional N-P null hypothesis significance testing.

The Effectiveness of Cognitive Exposure & Skills Group Manualized Treatments in OIF/OEF Female Veterans

DTIC Science & Technology

2011-04-01

2004). PTSD and somatization in women treated at a VA primary care clinic. Psychosomatics, 45, 291-296. Foa, E. B., Dancu, C. V., Hembree, E...were clinically significant elevations (> 70) on the Demoralization, Somatic Complaints, Low Positive Emotion of the Restructured Clinical scales and... Hypochondriasis , Psych Dev = Psychopathic Deviate, Masc-Fem = Masculinity- Femininity, Psychasth = Psychasthenia, Schizoph = Schizophrenia; Soc Introv

A preliminary analysis of microRNA as potential clinical biomarker for schizophrenia.

PubMed

Sun, Xin-yang; Zhang, Jin; Niu, Wei; Guo, Wei; Song, Hong-tao; Li, Heng-yu; Fan, Hui-min; Zhao, Lin; Zhong, Ai-fang; Dai, Yun-hua; Guo, Zhong-min; Zhang, Li-yi; Lu, Jim; Zhang, Qiao-li

2015-04-01

MicroRNAs (miRNA, miR) have been implicated as promising blood-based biomarkers for schizophrenia patients. This study aimed to clinically validate miRNA as potential schizophrenia biomarkers. Plasma levels of 10 miRNAs were analyzed using qPCR in a cohort of 61 schizophrenia patients and 62 normal controls, as well as 25 patients particularly selected for a six-week antipsychotic treatment course. Positive And Negative Syndrome Scale (PANSS), Global Assessment Scale (GAS) and Clinical Global Impression (CGI) were administered to assess the clinical symptoms. The results demonstrated that a panel of miRNAs consisting of miR-30e, miR-181b, miR-34a, miR-346 and miR-7 had significantly increased expression levels with significant combined diagnostic value (AUC:0.713; sensitivity:35.5%; specificity:90.2%). In response to pharmacological treatment, expression levels of miR-132, miR-181b, miR-432 and miR-30e were significantly decreased. In addition, the improvement of clinical symptomatology was significantly correlated with the changes of miR-132, miR-181b, miR-212 and miR-30e expression levels. Furthermore, the decreases of plasma levels of miR-132 and miR-432 were significantly greater in high-effect subgroup than those in low-effect subgroup after six-week treatment course. We conclude that miR-30e, miR-181b, miR-34a, miR-346 and miR-7 combined as a panel are potentially useful non-invasive biomarkers for schizophrenia diagnosis. Markers miR-132, miR-181b, miR-30e and miR-432 are potential indicators for symptomatology improvements, treatment responses and prognosis for schizophrenia patients. © 2015 Wiley Periodicals, Inc.

Modulation of renal oxygenation and perfusion in rat kidney monitored by quantitative diffusion and blood oxygen level dependent magnetic resonance imaging on a clinical 1.5T platform.

PubMed

Jerome, Neil P; Boult, Jessica K R; Orton, Matthew R; d'Arcy, James; Collins, David J; Leach, Martin O; Koh, Dow-Mu; Robinson, Simon P

2016-10-03

To investigate the combined use of intravoxel incoherent motion (IVIM) diffusion-weighted (DW) and blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) to assess rat renal function using a 1.5T clinical platform. Multiple b-value DW and BOLD MR images were acquired from adult rats using a parallel clinical coil arrangement, enabling quantitation of the apparent diffusion coefficient (ADC), IVIM-derived diffusion coefficient (D), pseudodiffusion coefficient (D*) and perfusion fraction (f), and the transverse relaxation time T 2 *, for whole kidney, renal cortex, and medulla. Following the acquisition of two baseline datasets to assess measurement repeatability, images were acquired following i.v. administration of hydralazine, furosemide, or angiotensin II for up to 40 min. Excellent repeatability (CoV <10 %) was observed for ADC, D, f and T 2 * measured over the whole kidney. Hydralazine induced a marked and significant (p < 0.05) reduction in whole kidney ADC, D, and T 2 *, and a significant (p < 0.05) increase in D* and f. Furosemide significantly (p < 0.05) increased whole kidney ADC, D, and T 2 *. A more variable response to angiotensin II was determined, with a significant (p < 0.05) increase in medulla D* and significant (p < 0.05) reduction in whole kidney T 2 * established. Multiparametric MRI, incorporating quantitation of IVIM DWI and BOLD biomarkers and performed on a clinical platform, can be used to monitor the acute effects of vascular and tubular modulating drugs on rat kidney function in vivo. Clinical adoption of such functional imaging biomarkers can potentially inform on treatment effects in patients with renal dysfunction.

The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis: A randomized clinical trial

PubMed Central

Bhate, Devaki; Jain, Sanjay; Kale, Rahul; Muglikar, Sangeeta

2015-01-01

Background: Chlorhexidine (CHX) is considered as a gold standard of antimicrobial rinses. Various herbal oral rinses are available in the market. However, little is known of its effectiveness. Aim: The aim of this study was to evaluate the clinical changes after the usage of herbal oral rinse and 0.12% CHX. Materials and Methods: In a randomized clinical trial, 76 patients with dental plaque-induced gingivitis were assigned to Group I (Herbal Oral Rinse - Hiora®) and 76 patients with dental plaque-induced gingivitis to Group II (0.12% Chlorhexidine-Peridex®). Gingival index and Plaque index scores were recorded at baseline and 21 days after scaling. Results: Intragroup comparison in both groups showed that plaque index and gingival index scores were statistically significant after 21 days as compared to baseline. Intergroup comparison showed that plaque index scores and gingival index scores were statistically significant in Group II as compared to Group I. Conclusion: When herbal oral rinse was compared to 0.12% CHX, 0.12% CHX mouth rinse effectively reduced the clinical symptoms of plaque-induced gingivitis. PMID:26392686

Tanezumab in the treatment of chronic musculoskeletal conditions.

PubMed

Jayabalan, Prakash; Schnitzer, Thomas J

2017-02-01

The management of pain associated with chronic musculoskeletal conditions represents a significant challenge for the clinician. There remains a need for novel medications that have a significant analgesic benefit and are also safe and well tolerated. Both pre-clinical and clinical data have provided evidence of the role of nerve growth factor (NGF) in a multitude of pain eliciting conditions. Therefore, the development of monoclonal antibodies to NGF for chronic painful musculoskeletal conditions has generated interest. Areas covered: This manuscript is a review that examines both the pharmacological properties and clinical studies of tanezumab, the most widely studied antibody to NGF, for management of osteoarthritis (OA) and low back pain. In addition, the safety and tolerability profile and development history of tanezumab are also discussed. Expert opinion: Most studies provide strong support for the ability of tanezumab to provide clinically meaningful pain relief in individuals with these conditions, with longer-term studies suggesting durability of effect. The adverse event profile appears favorable, assuming the risk mitigation strategies are effective at reducing the incidence of joint-related side effects. Further data are being collected to define the optimal dose and dosing strategy in both OA and chronic low back pain.

Understanding Clinical Expertise: Nurse Education, Experience, and the Hospital Context

PubMed Central

McHugh, Matthew D.; Lake, Eileen T.

2010-01-01

Clinical nursing expertise is central to quality patient care. Research on factors that contribute to expertise has focused largely on individual nurse characteristics to the exclusion of contextual factors. To address this, we examined effects of hospital contextual factors and individual nurse education and experience on clinical nursing expertise in a cross-sectional analysis of data from 8,611 registered nurses. In a generalized ordered logistic regression analysis, the composition of the hospital staff, particularly the proportion of nurses with at least a bachelor of science in nursing degree, was associated with significantly greater odds of a nurse reporting a more advanced expertise level. Our findings suggest that, controlling for individual characteristics, the hospital context significantly influences clinical nursing expertise. PMID:20645420

Effectiveness of cross polarized light and fluorescence diagnosis for detection of sub-clinical and clinical actinic keratosis during imiquimod treatment.

PubMed

Ortonne, Jean-Paul; Gupta, Girish; Ortonne, Nicolas; Duteil, Luc; Queille, Catherine; Mallefet, Pascal

2010-07-01

During treatment of actinic keratosis (AK) lesions with imiquimod sub-clinical lesions often become visible. It is, however, unclear whether these sub-clinical lesions would be detectable beforehand. The aim of this pilot study was to compare two techniques, cross polarized light photography (CPL) and fluorescence diagnosis (FD) using methyllevulinic acid and illumination with Wood's lamp for their ability to detect sub-clinical lesions. These findings were also compared with biopsy results taken before and after treatment with imiquimod 5% cream or vehicle. Twelve patients with at least five clinically visible AK lesions in a single contiguous 20 cm(2) area on the head were recruited. Patient eligibility was determined at the screening visit, when they were randomized to treatment. The randomization was 3:1, active to vehicle (nine treated with imiquimod, three with vehicle cream) for a total duration of 24 weeks (six clinic visits). Patients were assessed for baseline AK lesion counts (clinical and sub-clinical) at the screening visit and final counts at week 20. The number of clinically observed AK lesions was significantly lower at week 12 and week 20 compared with baseline following imiquimod treatment versus vehicle. The number of counted lesions were significantly higher using the CPL method compared with clinical counting with imiquimod treatment at baseline (8.3 +/- 3.4 vs 5.8 +/- 1.3; P = 0.027) and week 20 (4.8 +/- 2.4 vs 3.0 +/- 1.7; P = 0.02) but not in the vehicle group. The FD lesion counting method did not show a significant increase in the number of detected lesions compared with clinical analysis in the imiquimod and placebo groups but when comparisons were performed using pooled data (treatments and visits combined) the results were significant. The number of sub-clinical and clinical AK lesions detected during treatment with imiquimod can be better demonstrated using the methods of CPL and FD, but statistical significance was reached only using the CPL method. This is only a preliminary study with a small number of patients and as a result it is difficult to conclude both statistical and clinical significance. However, results were encouraging and indicate that larger studies are needed to demonstrate the relevance of these two new methods for improved detection of clinical and especially sub-clinical AK lesions.

Hyperbaric oxygen therapy stimulates colonic stem cells and induces mucosal healing in patients with refractory ulcerative colitis: a prospective case series

PubMed Central

Bekheit, Mohamed; Baddour, Nahed; Katri, Khaled; Taher, Yousry; El Tobgy, Khaled; Mousa, Essam

2016-01-01

Background Hyperbaric oxygen (HBO) is used as part of treatment in a variety of clinical conditions. Its use in the treatment of ulcerative colitis has been reported in few clinical reports. Objective We report the effect of HBO on refractory ulcerative colitis exploring one potential mechanism of action. Design A review of records of patients with refractory ulcerative colitis who received HBO was conducted. Clinical and histopathological scoring was utilised to evaluate the response to HBO therapy (HBOT). Results All patients manifested clinical improvement by the 40th cycle of HBOT. The median number of stool frequency dropped from seven motions/day (range=3–20) to 1/day (range=0.5–3), which was significant (z=−4.6, p<0.001). None of the patients manifested persistent blood passage after HBOT (z=−3.2, p=0.002). The severity index significantly improved after HBOT (z=−4.97, p<0.001). Histologically, a significant reduction of the scores of activity was recorded accompanied by a significant increase in the proliferating cell nuclear antigen labelling index of the CD44 cells of the colonic mucosa (p=0.001). Conclusions HBOT is effective in the setting of refractory ulcerative colitis. The described protocol is necessary for successful treatment. HBOT stimulates colonic stem cells to promote healing. PMID:27195128

Effect of L-thyroxine treatment versus a placebo on serum lipid levels in patients with sub-clinical hypothyroidism

PubMed Central

Li, Xue; Meng, Zhaowei; Jia, Qiang; Ren, Xiaojun

2016-01-01

Sub-clinical hypothyroidism is a common disease and whether L-thyroxine replacement treatment improves serum lipid levels in affected patients remains controversial. Thus, the aim of the present meta-analysis was to assess the effect of L-thyroxine therapy on serum lipid levels in sub-clinical hyperthyroidism. Relevant randomized controlled trials (RCTs) containing continuous data, published until July 2015 were retrieved from the Cochrane Library, PubMed, Medline, Google Scholar and Embase databases and subjected to meta-analysis using Review Manager software version 5.2 (The Nordic Cochrane Centre, Copenhagen, Denmark). Seven RCTs comprising 319 patients were included. The overall methodological quality of the RCTs was good. Statistical analysis revealed that serum low-density lipoprotein-cholesterol (LDL-C) levels were significantly decreased after L-thyroxine treatment [mean difference (MD): −0.23; 95% confidence interval: −0.44, −0.03; P=0.02], while changes of total cholesterol (TC), triglyceride (TG) and high-density lipoprotein-cholesterol (HDL-C) were not significant (MD: −0.18, P=0.09; MD: −0.02, P=0.78; and MD: −0.06, P=0.14, respectively). In conclusion, the meta-analysis performed in the present study revealed that compared with placebo treatment, L-thyroxine significantly improved serum LDL-C levels in patients with sub-clinical hypothyroidism, while not significantly affecting TC, TG and HDL-C levels. PMID:27699011

Zhen Gan Xi Feng Decoction, a Traditional Chinese Herbal Formula, for the Treatment of Essential Hypertension: A Systematic Review of Randomized Controlled Trials

PubMed Central

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use. PMID:23573163

Developing Canadian physician: the quest for leadership effectiveness.

PubMed

Comber, Scott; Wilson, Lisette; Crawford, Kyle C

2016-07-04

Purpose The purpose of this study is to discern the physicians' perception of leadership effectiveness in their clinical and non-clinical roles (leadership) by identifying their political skill levels. Design/methodology/approach A sample of 209 Canadian physicians was surveyed using the Political Skills Inventory (PSI) during the period 2012-2014. The PSI was chosen because it assesses leadership effectiveness on four dimensions: social astuteness, interpersonal influence, networking ability and apparent authenticity. Findings Physicians in clinical roles' PSI scores were significantly lower in all four PSI dimensions when compared to all other physicians in non-clinical roles, with the principal difference being in their networking abilities. Practical implications More emphasis is needed on educating and training physicians, specifically in the areas of political skills, in current clinical roles if they are to assume leadership roles and be effective. Originality/value Although this study is located in Canada, the study design and associated findings may have implications to other areas and countries wanting to increase physician leadership effectiveness. Further, replication of this study in other settings may provide insight into the future design of physician leadership training curriculum.

[Study on effects of low frequency pulse plus auricular point magnetic therapy on electrogastrogram and clinical therapeutic effect in the patient of functional dyspepsia].

PubMed

Wang, Yan-Gang; Yao, Shu-Kun

2007-04-01

To compare therapeutic effects of low frequency pulse plus auricular point magnetic therapy and prepulsid on functional dyspepsia (FD). Fifty cases of FD were randomly divided into a treatment group and a control group. The treatment group were treated with low frequency pulse stimulation on Zhongwan (CV 12), Weishu (BL 21), Neiguan (PC 6), Zusanli (ST 36), with Fenglong (ST 40) and Sanyinjiao (SP 6) selected according to syndrome differentiation, once a day, 30 min each session. The control group were treated with oral administration of prepulsid. Five days constituted one course. The scores of symptoms and parameters of electrogastrogram (EGG) before and after treatment and the therapeutic effect were investigated. After treatment, the symptom scores significantly decreased (P < 0.01), with a significant difference in the decrease of symptom scores between the two groups (P < 0.05); and EGG parameters were improved (P < 0.05). The total effective rate of 93.3% in the treatment group was better than 75.0% in the control group with a significant difference between the two groups (P < 0.05). Low frequency pulse plus auricular point magnetic therapy can significantly improve the clinical symptoms and gastric activities in the patient of FD, with a better therapeutic effect than prepulsid.

Effectiveness and safety of Glucosamine, chondroitin, the two in combination, or celecoxib in the treatment of osteoarthritis of the knee

PubMed Central

Zeng, Chao; Wei, Jie; Li, Hui; Wang, Yi-lun; Xie, Dong-xing; Yang, Tuo; Gao, Shu-guang; Li, Yu-sheng; Luo, Wei; Lei, Guang-hua

2015-01-01

This study aimed to investigate the effectiveness and safety of glucosamine, chondroitin, the two in combination, or celecoxib in the treatment of knee osteoarthritis (OA). PubMed, Embase and Cochrane Library were searched through from inception to February 2015. A total of 54 studies covering 16427 patients were included. Glucosamine plus chondroitin, glucosamine alone, and celecoxib were all more effective than placebo in pain relief and function improvement. Specifically, celecoxib is most likely to be the best treatment option, followed by the combination group. All treatment options showed clinically significant improvement from baseline pain, but only glucosamine plus chondroitin showed clinically significant improvement from baseline function. In terms of the structure-modifying effect, both glucosamine alone and chondroitin alone achieved a statistically significant reduction in joint space narrowing. Although no significant difference was observed among the five options with respect to the three major adverse effects (withdrawal due to adverse events, serious adverse events and the number of patients with adverse events), the additional classical meta-analysis showed that celecoxib exhibited a higher rate of gastrointestinal adverse effect comparing with the placebo group. The present study provided evidence for the symptomatic efficacy of glucosamine plus chondroitin in the treatment of knee OA. PMID:26576862

Comparison on therapeutic effect of plasma exchange and intravenous immunoglobulin for Guillian-Barre syndrome.

PubMed

Ye, Y; Li, S-L; Li, Y-J

2015-04-01

To observe and compare the clinical curative effect of the plasma exchange (PE) and intravenous immunoglobulin (IVIg) for Guillian-Barre Syndrome (GBS). Overall, 64 adult patients with GBS for PE and IVIg treatment, respectively, and nerve function were observed pre-treatment and at 1 week/2 weeks after completion of treatment; the blood immunoglobulin, complement, fibrinogen (Fib) and monocyte percentage (MON%) were detected simultaneously. After PE treatment, nerve function defect appeared to improve better than the IVIg group and clinical effect was better than the IVIg group. Treatment effective rates of the two groups after 2 weeks, respectively, are 96 and 79%. PE and IVIg can significantly reduce the GBS patients' blood immunoglobulin IgG, IgA, IgM, C3 and C4, but these were significantly lower in the PE group than in the IVIg group. Fib and MON% were significantly lower in the PE group than in the IVIg group. Both PE and IVIg have a high response as therapy and are reasonable therapeutic options for GBS. However, PE treatment has a more significantly curative effect, as it can effectively improve symptoms and be helpful in the early rehabilitation of patients. © 2014 British Blood Transfusion Society.

Constraint-induced movement therapy for children with hemiplegia after traumatic brain injury: a quantitative study.

PubMed

Cimolin, Veronica; Beretta, Elena; Piccinini, Luigi; Turconi, Anna Carla; Locatelli, Federica; Galli, Manuela; Strazzer, Sandra

2012-01-01

The aims of this study are to quantify the movement limitation of upper limbs in hemiplegic children with traumatic brain injury (TBI) by using a clinical-functional scale and upper limb kinematics and to evaluate the effectiveness of constraint-induced movement therapy (CIMT) on upper limbs. Pre-post study. Clinical rehabilitation research laboratory. Ten children with TBI. The participants were evaluated by clinical examinations (Gross Motor Function Measure, Besta scale, Quality of Upper Extremities Skills Test, and Manual Ability Classification System) and 3D kinematic movement analysis of the upper limb before the CIMT program (pretest: 0.7 years after the injury) and at the end of the program (posttest: 10 weeks later). After the CIMT, most of the clinical measures improved significantly. Some significant improvements were present in terms of kinematics, in particular, in the movement duration and the velocity of movement execution of both tasks; the index of curvature and the average jerk improved, respectively, during reaching and hand-to-mouth task, while the adjusting sway parameter decreased during the 2 movements. Significant improvements were found in upper limb joint excursion after the rehabilitative programme too. Our results suggest that the CIMT program can improve movement efficiency and upper limb function in children after TBI. The integration of the clinical outcomes and upper limb kinematics revealed to be crucial in detecting the effects of the CIMT programme.

A Systematic Review of Community-Based Participatory Research to Enhance Clinical Trials in Racial and Ethnic Minority Groups

PubMed Central

De Las Nueces, Denise; Hacker, Karen; DiGirolamo, Ann; Hicks, LeRoi S

2012-01-01

Objective To examine the effectiveness of current community-based participatory research (CBPR) clinical trials involving racial and ethnic minorities. Data Source All published peer-reviewed CBPR intervention articles in PubMed and CINAHL databases from January 2003 to May 2010. Study Design We performed a systematic literature review. Data Collection/Extraction Methods Data were extracted on each study's characteristics, community involvement in research, subject recruitment and retention, and intervention effects. Principle Findings We found 19 articles meeting inclusion criteria. Of these, 14 were published from 2007 to 2010. Articles described some measures of community participation in research with great variability. Although CBPR trials examined a wide range of behavioral and clinical outcomes, such trials had very high success rates in recruiting and retaining minority participants and achieving significant intervention effects. Conclusions Significant publication gaps remain between CBPR and other interventional research methods. CBPR may be effective in increasing participation of racial and ethnic minority subjects in research and may be a powerful tool in testing the generalizability of effective interventions among these populations. CBPR holds promise as an approach that may contribute greatly to the study of health care delivery to disadvantaged populations. PMID:22353031

A comparison of the use, effectiveness and safety of bezafibrate, gemfibrozil and simvastatin in normal clinical practice using the New Zealand Intensive Medicines Monitoring Programme (IMMP)

PubMed Central

Beggs, Peter W; Clark, David WJ; Williams, Sheila M; Coulter, David M

1999-01-01

Aims Because of the importance of treating dyslipidaemia in the prevention of ischaemic heart disease and because patient selection criteria and outcomes in clinical trials do not necessarily reflect what happens in normal clinical practice, we compared outcomes from bezafibrate, gemfibrozil and simvastatin therapy under conditions of normal use. Methods A random sample of 200 patients was selected from the New Zealand Intensive Medicines Monitoring Programme’s (IMMP) patient cohorts for each drug. Questionnaires sent to prescribers requested information on indications, risk factors for ischaemic heart disease, lipid profiles with changes during treatment and reasons for stopping therapy. Results 80% of prescribers replied and 83% of these contained useful information. The three groups were similar for age, sex and geographical region, but significantly more patients on bezafibrate had diabetes and/or hypertension than those on gemfibrozil or simvastatin. After treatment and taking the initial measure into account, the changes in serum lipid values were consistent with those generally observed, but with gemfibrozil being significantly less effective than expected. More patients (15.8%) stopped gemfibrozil because of an inadequate response compared with bezafibrate (5.4%) and simvastatin (1.6%). Gemfibrozil treatment was also withdrawn significantly more frequently due to a possible adverse reaction compared with the other two drugs. Conclusions In normal clinical practice in New Zealand gemfibrozil appears less effective and more frequently causes adverse effects leading to withdrawal of treatment than either bezafibrate or simvastatin. PMID:10073746

Subpedicle connective tissue graft versus guided tissue regeneration with bioabsorbable membrane in the treatment of human gingival recession defects.

PubMed

Trombelli, L; Scabbia, A; Tatakis, D N; Calura, G

1998-11-01

The purpose of the present clinical study was to evaluate the effect of guided tissue regeneration (GTR) in comparison to subpedicle connective tissue graft (SCTG) in the treatment of gingival recession defects. A total of 12 patients, each contributing a pair of Miller's Class I or II buccal gingival recessions, was treated. According to a randomization list, one defect in each patient received a polyglycolide/lactide bioabsorbable membrane, while the paired defect received a SCTG. Treatment effect was evaluated 6 months postsurgery. Clinical recordings included full-mouth and defect-specific oral hygiene standards and gingival health, recession depth (RD), recession width (RW), probing depth (PD), clinical attachment level (CAL), and keratinized tissue width (KT). Mean RD significantly decreased from 3.1 mm presurgery to 1.5 mm at 6 months postsurgery for the GTR group (48% root coverage), and from 3.0 mm to 0.5 mm for the SCTG group (81% root coverage). RD reduction and root coverage were significantly greater in SCTG group compared to GTR group. Mean CAL gain amounted to 1.7 mm for the GTR group, and 2.3 mm in the SCTG group. No significant differences in PD changes were observed within and between groups. KT increased significantly from presurgery for both treatment groups, however gingival augmentation was significantly greater in the SCTG group compared to GTR group. Results indicate that: 1) treatment of human gingival recession defects by means of both GTR and SCTG procedures results in clinically and statistically significant improvement of the soft tissue conditions of the defect; and 2) treatment outcome was significantly better following SCTG compared to GTR in terms of recession depth reduction, root coverage, and keratinized tissue increase.

[Expression of multidrug resistance P-170 and MRP and their correlation with clinical drug resistance in acute leukemia].

PubMed

Lin, Xiu-mei; Xie, Zhao-xia; Zhu, Yan

2002-12-28

To investigate the relevance between the expression of P-170 and MRP and clinical drug resistance in acute leukemia. The expression of P-170 and MRP in mononuclear cells of bone marrows was analyzed by the immunohistochemical technique in 72 acute leukemia patients. The expression of P-170 was positive in 46 and negative in 26 of the 72 post-chemotherapy acute leukemia patients. The therapeutic effect of the P-170 positive expression patients was significantly poorer than that of the negative expression patients (P < 0.01). The expression of MRP was positive in 39 and negative in 33 of the 72 post-chemotherapy acute leukemia patients. The therapeutic effect of the MRP positive expression patients was significantly poorer than that in the negative expression patients (P < 0.01). The expression of P-170 and MRP had a significant concordance (Kappa = 0.427, P < 0.01). The sensitivity of P-170 and MRP which were analyzed simultaneously was 97.5%, which was higher than that of P-170 (90%) or MRP (77.5%) analyzed respectively in drug resistance patients. The expression of P-170 and/or MRP was significantly related with drug resistance in clinical chemotherapy. The therapeutic effect was significantly poorer in P-170 and/or MRP positive expression patients than that in negative expression patients. These data suggest that P-170 and MRP analyzed simultaneously can improve the value of diagnosis and prognosis in patients with drug resistance leukemia.

The effect of preparation strategies, qualification and professional background on clinical nurse educator confidence.

PubMed

Nguyen, Van N B; Forbes, Helen; Mohebbi, Mohammadreza; Duke, Maxine

2018-06-12

To describe how clinical nurse educators in Vietnam are prepared for their role; to identify which preparation strategies assist development of confidence in clinical teaching; and to measure the effect of educational qualifications and professional background on perceived confidence levels. The quality of clinical teaching can directly affect the quality of the student learning experience. The role of the clinical educator is complex and dynamic and requires a period of adjustment for successful role transition to occur. Planned orientation and specific preparation programs assist transition and reduce anxiety for new clinical nurse educators. There is, however, a lack of clear evidence to identify the form this preparation should take or which strategies are likely to facilitate the development of role confidence. Descriptive survey study. Cross-sectional surveys were used to collect data from 334 clinical nurse educators during January - March 2015. Eight preparation methods commonly used in Vietnam were identified. There was a small yet significant association between preparation and clinical nurse educators' perceived confidence. Formal preparation methods, as well as postgraduate qualifications and years of clinical teaching experience were linked to increased confidence in clinical teaching. Conversely, informal mentorship was found to hinder confidence development. This study identifies several preparation strategies that significantly enhance clinical educator confidence and readiness for their complex role. These preparation strategies drawn from the Vietnamese context, provide important examples for the wider nursing community to consider. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

[Pharmacokinetics and the clinical effect of bemitil after a single administration].

PubMed

Boĭko, S S; Bobkov, Iu G; Neznamov, G G; Serebriakova, T V

1986-01-01

It was found on studying a novel psychotropic drug bemitil that after its single administration kinetic curves significantly differed depending on a clinical effect of the test dose in patients with asthenic states. At predomination of the psychoactivating component of action one could note a larger area under the concentration-time relationship curve and a shorter period of half-excretion than in patients with the tranquilizing action. The obtained data on the difference in the drug test dose effect depending on the drug pharmacokinetics should be taken into consideration at determination of bemitil course therapy duration in patients with neuroses and neurosis-like states with predominance of asthenic disturbances in the clinical picture.

Granulocyte antigen systems and antibodies and their clinical significance

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

McCullough, J.

Granulocyte alloantibodies and autoantibodies have a key role in the pathophysiology of several clinical problems. These include febrile transfusion reactions, severe pulmonary reactions to transfusion, isoimmune neonatal neutropenia, failure of effective granulocyte transfusion, autoimmune neutropenia, drug-induced neutropenia, and neutropenias secondary to many other diseases. Although many techniques are available for detecting granulocyte antibodies, the optimal in-vitro tests for predicting the antibodies' clinical effects are not established. Use of indium-111-labeled granulocytes may provide valuable information regarding the in-vivo effects of different granulocyte antibodies. Granulocyte transfusions continue to be used for a limited number of severely infected neutropenic patients who do notmore » respond to antibiotic therapy.« less

The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial.

PubMed

Anderson-Hanley, Cay; Barcelos, Nicole M; Zimmerman, Earl A; Gillen, Robert W; Dunnam, Mina; Cohen, Brian D; Yerokhin, Vadim; Miller, Kenneth E; Hayes, David J; Arciero, Paul J; Maloney, Molly; Kramer, Arthur F

2018-01-01

Prior research has found that cognitive benefits of physical exercise and brain health in older adults may be enhanced when mental exercise is interactive simultaneously, as in exergaming. It is unclear whether the cognitive benefit can be maximized by increasing the degree of mental challenge during exercise. This randomized clinical trial (RCT), the Aerobic and Cognitive Exercise Study (ACES) sought to replicate and extend prior findings of added cognitive benefit from exergaming to those with or at risk for mild cognitive impairment (MCI). ACES compares the effects of 6 months of an exer-tour (virtual reality bike rides) with the effects of a more effortful exer-score (pedaling through a videogame to score points). Fourteen community-dwelling older adults meeting screening criteria for MCI (sMCI) were adherent to their assigned exercise for 6 months. The primary outcome was executive function, while secondary outcomes included memory and everyday cognitive function. Exer-tour and exer-score yielded significant moderate effects on executive function (Stroop A/C; d 's = 0.51 and 0.47); there was no significant interaction effect. However, after 3 months the exer-tour revealed a significant and moderate effect, while exer-score showed little impact, as did a game-only condition. Both exer-tour and exer-score conditions also resulted in significant improvements in verbal memory. Effects appear to generalize to self-reported everyday cognitive function. Pilot data, including salivary biomarkers and structural MRI, were gathered at baseline and 6 months; exercise dose was associated with increased BDNF as well as increased gray matter volume in the PFC and ACC. Improvement in memory was associated with an increase in the DLPFC. Improved executive function was associated with increased expression of exosomal miRNA-9. Interactive physical and cognitive exercise (both high and low mental challenge) yielded similarly significant cognitive benefit for adherent sMCI exercisers over 6 months. A larger RCT is needed to confirm these findings. Further innovation and clinical trial data are needed to develop accessible, yet engaging and effective interventions to combat cognitive decline for the growing MCI population. ClinicalTrials.gov ID: NCT02237560.

The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial

PubMed Central

Anderson-Hanley, Cay; Barcelos, Nicole M.; Zimmerman, Earl A.; Gillen, Robert W.; Dunnam, Mina; Cohen, Brian D.; Yerokhin, Vadim; Miller, Kenneth E.; Hayes, David J.; Arciero, Paul J.; Maloney, Molly; Kramer, Arthur F.

2018-01-01

Prior research has found that cognitive benefits of physical exercise and brain health in older adults may be enhanced when mental exercise is interactive simultaneously, as in exergaming. It is unclear whether the cognitive benefit can be maximized by increasing the degree of mental challenge during exercise. This randomized clinical trial (RCT), the Aerobic and Cognitive Exercise Study (ACES) sought to replicate and extend prior findings of added cognitive benefit from exergaming to those with or at risk for mild cognitive impairment (MCI). ACES compares the effects of 6 months of an exer-tour (virtual reality bike rides) with the effects of a more effortful exer-score (pedaling through a videogame to score points). Fourteen community-dwelling older adults meeting screening criteria for MCI (sMCI) were adherent to their assigned exercise for 6 months. The primary outcome was executive function, while secondary outcomes included memory and everyday cognitive function. Exer-tour and exer-score yielded significant moderate effects on executive function (Stroop A/C; d's = 0.51 and 0.47); there was no significant interaction effect. However, after 3 months the exer-tour revealed a significant and moderate effect, while exer-score showed little impact, as did a game-only condition. Both exer-tour and exer-score conditions also resulted in significant improvements in verbal memory. Effects appear to generalize to self-reported everyday cognitive function. Pilot data, including salivary biomarkers and structural MRI, were gathered at baseline and 6 months; exercise dose was associated with increased BDNF as well as increased gray matter volume in the PFC and ACC. Improvement in memory was associated with an increase in the DLPFC. Improved executive function was associated with increased expression of exosomal miRNA-9. Interactive physical and cognitive exercise (both high and low mental challenge) yielded similarly significant cognitive benefit for adherent sMCI exercisers over 6 months. A larger RCT is needed to confirm these findings. Further innovation and clinical trial data are needed to develop accessible, yet engaging and effective interventions to combat cognitive decline for the growing MCI population. ClinicalTrials.gov ID: NCT02237560 PMID:29780318

Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study)

PubMed Central

Suh, Sunghwan; Song, Sun Ok; Kim, Jae Hyeon; Cho, Hyungjin

2017-01-01

The present observational study aimed to evaluate the clinical effectiveness of vildagliptin with metformin in Korean patients with type 2 diabetes mellitus (T2DM). Data were pooled from the vildagliptin postmarketing survey (PMS), the vildagliptin/metformin fixed drug combination (DC) PMS, and a retrospective observational study of vildagliptin/metformin (fixed DC or free DC). The effectiveness endpoint was the proportion of patients who achieved a glycemic target (HbA1c) of ≤7.0% at 24 weeks. In total, 4303 patients were included in the analysis; of these, 2087 patients were eligible. The mean patient age was 56.99 ± 11.25 years. Overall, 58.94% patients achieved an HbA1c target of ≤7.0% at 24 weeks. The glycemic target achievement rate was significantly greater in patients with baseline HbA1c < 7.5% versus ≥7.5% (84.64% versus 43.97%), receiving care at the hospital versus clinic (67.95% versus 52.33%), and receiving vildagliptin/metformin fixed DC versus free DC (70.69% versus 55.42%). Multivariate logistic regression analysis indicated that disease duration (P < 0.0001), baseline HbA1c (P < 0.0001), and DC type (P = 0.0103) had significant effects on drug effectiveness. Vildagliptin plus metformin appeared as an effective treatment option for patients with T2DM in clinical practice settings in Korea. PMID:29057274

Effect of Gum Arabic (Acacia Senegal) supplementation on visceral adiposity index (VAI) and blood pressure in patients with type 2 diabetes mellitus as indicators of cardiovascular disease (CVD): a randomized and placebo-controlled clinical trial.

PubMed

Babiker, Rasha; Elmusharaf, Khalifa; Keogh, Michael B; Saeed, Amal M

2018-03-20

There is a strong association between cardiometabolic risk and adipose tissue dysfunction with great consequences on type 2 diabetic patients. Visceral Adiposity Index (VAI) is an indirect clinical marker of adipose tissue dysfunction. Gum Arabic (GA) is a safe dietary fiber, an exudate of Acacia Senegal. Gum Arabic had shown lipid lowering effect in both humans and animals. The aim of this trial was to determine the effect of GA supplementation on anthropometric obesity marker, Visceral Adiposity Index (VAI) and blood pressure in patients with type 2 diabetes mellitus. This randomized, double blinded, placebo controlled trial recruited a total of 91 type 2 diabetic patients (73 females, 18 males), age (mean ± SD) 50.09 ± 9.3 years on hypoglycemic agents and were randomly assigned into two groups, either to consume 30 g of GA or 5 g of placebo daily for 3 months. Anthropometric obesity markers were measured and indices were calculated. Blood pressure was measured and high density lipoprotein (HDL) and triglycerides (TG) were determined in fasting blood samples at the start and end of the study period. After intervention, Gum Arabic decreased BMI and VAI significantly (P < 0.05) in GA group by 2 and 23.7% respectively. Body adiposity index significantly decreased by 3.9% in GA group while there were no significant changes in waist circumference or waist-to-hip ratio (WHR). Systolic blood pressure significantly decreased by 7.6% in GA group and by 2.7% in placebo group from baseline with no significant changes in diastolic blood pressure in the two groups. Gum Arabic consumption at a dose of 30 g/d for 3 months may play an effective role in preventing weight gain and modulating adipose tissue dysfunction in type 2 diabetic patients, although no effect has been shown in waist-to-hip ratio. The trial had been registered as prospective interventional clinical trials in the Pan African Clinical Trial Registry (PACTR) PACTR201403000785219 , on 7th March 2014.

Clinical outcome associated with the use of different inhalation method with and without humidification in asthmatic mechanically ventilated patients.

PubMed

Moustafa, Islam O F; ElHansy, Muhammad H E; Al Hallag, Moataz; Fink, James B; Dailey, Patricia; Rabea, Hoda; Abdelrahim, Mohamed E A

2017-08-01

Inhaled-medication delivered during mechanical-ventilation is affected by type of aerosol-generator and humidity-condition. Despite many in-vitro studies related to aerosol-delivery to mechanically-ventilated patients, little has been reported on clinical effects of these variables. The aim of this study was to determine effect of humidification and type of aerosol-generator on clinical status of mechanically ventilated asthmatics. 72 (36 females) asthmatic subjects receiving invasive mechanical ventilation were enrolled and assigned randomly to 6 treatment groups of 12 (6 females) subjects each received, as possible, all inhaled medication using their assigned aerosol generator and humidity condition during delivery. Aerosol-generators were placed immediately after humidifier within inspiratory limb of mechanical ventilation circuit. First group used vibrating-mesh-nebulizer (Aerogen Solo; VMN) with humidification; Second used VMN without humidification; Third used metered-dose-inhaler with AeroChamber Vent (MDI-AV) with humidification; Forth used MDI-AV without humidification; Fifth used Oxycare jet-nebulizer (JN) with humidification; Sixth used JN without humidification. Measured parameters included clinical-parameters reflected patient response (CP) and endpoint parameters e.g. length-of-stay in the intensive-care-unit (ICU-days) and mechanical-ventilation days (MV-days). There was no significant difference between studied subjects in the 6 groups in baseline of CP. VMN resulted in trend to shorter ICU-days (∼1.42days) compared to MDI-AV (p = 0.39) and relatively but not significantly shorter ICU-days (∼0.75days) compared JN. Aerosol-delivery with or without humidification did not have any significant effect on any of parameters studied with very light insignificant tendency of delivery at humid condition to decrease MV-days and ICU-days. No significant effect was found of changing humidity during aerosol-delivery to ventilated-patient. VMN to deliver aerosol in ventilated patient resulted in trend to decreased ICU-days compared to JN and MDI-AV. Aerosol-delivery with or without humidification did not have any significant effect on any of parameters studied. However, we recommend increasing the number of patients studied to corroborate this finding. Copyright © 2017 Elsevier Ltd. All rights reserved.

Birth Order and Sibling Sex Ratio of Children and Adolescents Referred to a Gender Identity Service

PubMed Central

VanderLaan, Doug P.; Blanchard, Ray; Wood, Hayley; Zucker, Kenneth J.

2014-01-01

In adult male samples, homosexuality is associated with a preponderance of older brothers (i.e., the fraternal birth order effect). In several studies comparing gender dysphoric youth, who are likely to be homosexual in adulthood, to clinical or non-clinical control groups, the findings have been consistent with the fraternal birth order effect in males; however, less is known about unique sibship characteristics of gender dysphoric females. The current study investigated birth order and sibling sex ratio in a large sample of children and adolescents referred to the same Gender Identity Service (N = 768). Probands were classified as heterosexual males, homosexual males, or homosexual females based on clinical diagnostic information. Groups differed significantly in age and sibship size, and homosexual females were significantly more likely to be only children. Subsequent analyses controlled for age and for sibship size. Compared to heterosexual males, homosexual males had a significant preponderance of older brothers and homosexual females had a significant preponderance of older sisters. Similarly, the older sibling sex ratio of homosexual males showed a significant excess of brothers whereas that of homosexual females showed a significant excess of sisters. Like previous studies of gender dysphoric youth and adults, these findings were consistent with the fraternal birth order effect. In addition, the greater frequency of only children and elevated numbers of older sisters among the homosexual female group adds to a small literature on sibship characteristics of potential relevance to the development of gender identity and sexual orientation in females. PMID:24651045

Cigarette smoking impairs clinical outcomes of assisted reproduction technologies: a meta-analysis of the literature.

PubMed

Budani, Maria Cristina; Fensore, Stefania; Di Marzio, Marco; Tiboni, Gian Mario

2018-06-12

There is convincing evidence that cigarette smoking can impair female reproductive potential. This meta-analysis updates the knowledge regarding the effects of cigarette smoking on clinical outcomes of assisted reproductive technologies (ART). Twenty-six studies were included in this meta-analysis. Results were expressed as odds ratios (OR) with 95% confidence intervals (CI) and statistical heterogeneity between the studies was evaluated with Higgins (I 2 ), Breslow (τ 2 ), Birge's ratio (H 2 ) indices and Chi-square test (χ 2 ). A P-value < 0.05 was considered statistically significant. The analysis showed a significant decrease in live birth rate per cycle for smoking patients (OR 0.59, 95% CI 0.44-0.79; P = 0.0005), a significant lower clinical pregnancy rate per cycle for smoking women (OR 0.53, 95% CI 0.41-0.68; P < 0.0001), and a significant increase in terms of spontaneous miscarriage rate (OR 2.22, 95% CI 1.10-4.48; P = 0.025) for smokers. These findings demonstrate clear negative effects of cigarette smoking on the outcome of ART programs. Copyright © 2018 Elsevier Inc. All rights reserved.

Effect of spinal anaesthesia on the lower urinary tract in continent women.

PubMed

Haeusler, G; Sam, C; Chiari, A; Tempfer, C; Hanzal, E; Koelbl, H

1998-01-01

To evaluate the effect of spinal anaesthesia on the bladder neck position and the urethral closure function in the resting state and during clinical stress test in healthy, continent women. Controlled clinical trial. Department of Gynaecology and Obstetrics, Vienna University Medical School. Fourteen continent women, of which seven were nulliparous and seven parous, underwent minor gynaecological procedures under spinal anaesthesia. Urodynamics and ultrasound investigations were performed before and during spinal anaesthesia. Changes in the bladder neck position and the urethral closure function before and during spinal anaesthesia. Bladder neck position was found to be lower and more posterior during spinal anaesthesia as compared with pre-operative assessment. The posterior urethrovesical angle increased significantly both at rest and during maximum straining. We observed a significant increase in bladder compliance, and all parameters of the urethral pressure profile decreased significantly. While none of the nulliparous women had a positive clinical stress test during spinal anaesthesia, 4/7 parous women demonstrated leakage (Fisher's exact test, P = 0.003). Blockage of nerve supply to the pelvic floor muscles in continent women is associated with a significant loss of support of the bladder neck region confirming the theory of an active mechanism of muscular elements providing continence.

Grape polyphenols and propolis mixture inhibits inflammatory mediator release from human leukocytes and reduces clinical scores in experimental arthritis.

PubMed

Mossalayi, M D; Rambert, J; Renouf, E; Micouleau, M; Mérillon, J M

2014-02-15

Polyphenols from red fruits and bee-derived propolis (PR) are bioactive natural products in various in vitro and in vivo models. The present study shows that hematotoxicity-free doses of grape polyphenols (GPE) and PR differentially decreased the secretion of pro-inflammatory cytokines from activated human peripheral blood leucocytes. While GPE inhibited the monocytes/macrophage response, propolis decreased both monokines and interferon γ (IFNγ) production. When used together, their distinct effects lead to the attenuation of all inflammatory mediators, as supported by a significant modulation of the transcriptomic profile of pro-inflammatory genes in human leukocytes. To enforce in vitro data, GPE+PR were tested for their ability to improve clinical scores and cachexia in chronic rat adjuvant-induced arthritis (AA). Extracts significantly reduced arthritis scores and cachexia, and this effect was more significant in animals receiving continuous low doses compared to those receiving five different high doses. Animals treated daily had significantly better clinical scores than corticoid-treated rats. Together, these findings indicate that the GPE+PR combination induces potent anti-inflammatory activity due to their complementary immune cell modulation. Copyright © 2013 Elsevier GmbH. All rights reserved.

Effects of Brief Psychoeducational Program on Stigma in Malaysian Pre-clinical Medical Students: A Randomized Controlled Trial.

PubMed

Fernandez, Aaron; Tan, Kit-Aun; Knaak, Stephanie; Chew, Boon How; Ghazali, Sazlina Shariff

2016-12-01

If presented with serious mental illness (SMI), individuals' low help-seeking behaviors and poor adherence to treatment are associated with negative stereotypes and attitudes of healthcare providers. In this study, we examined the effects of a brief psychoeducational program on reducing stigma in pre-clinical medical students. One hundred and two pre-clinical medical students (20-23 years old) were randomly assigned to face-to-face contact + educational lecture (n = 51) condition or video-based contact + educational lecture (n = 51) condition. Measures of pre-clinical medical students' mental illness-related stigma using the Opening Minds Stigma Scale for Health Care Providers (OMS-HC) were administered at pre-, post-treatment, and 1-month follow-up. A 2 (condition: face-to-face contact + educational lecture, video-based contact + educational lecture) by 3 (time: pre-treatment, post-treatment, and 1-month follow-up) mixed model MANOVA was conducted on the Attitudes, Disclosure and Help-Seeking, and Social Distance OMS-HC subscales. Participants' scores on all subscales changed significantly across time, regardless of conditions. To determine how participants' scores changed significantly over time on each subscale, Bonferroni follow-up comparisons were performed to access pairwise differences for the main effect of time. Specifically, pairwise comparisons produced a significant reduction in Social Distance subscale between pre-treatment and post-treatment and between pre-treatment and 1-month follow-up, and a significant increase between post-treatment and 1-month follow-up, regardless of conditions. With respect to the Attitudes and Disclosure and Help-Seeking subscales, pairwise comparisons produced a significant reduction in scores between pre-treatment and post-treatment and a significant increase between post-treatment and 1-month follow-up. Our findings provide additional evidence that educational lecture on mental illness, coupled with either face-to-face contact or video-based contact, is predictive of positive outcomes in anti-stigma programs targeting future healthcare providers.

Children with Phonological Problems: A Survey of Clinical Practice

ERIC Educational Resources Information Center

Joffe, Victoria; Pring, T.

2008-01-01

Background: Children with phonological problems are a significant proportion of many therapists' caseloads. However, little is known about current clinical practice with these children or whether research on the effects of therapy have influenced this practice. Aims: To investigate the methods of assessment and remediation used by therapists…

A review of the physical and metabolic effects of cross-sex hormonal therapy in the treatment of gender dysphoria.

PubMed

Seal, Leighton J

2016-01-01

This review focuses on the effect that cross-gender sex steroid therapy has on metabolic and hormonal parameters. There is an emphasis on those changes that result in significant clinical effects such as the positive effects of the development of secondary sexual characteristics and negative effects such as haemostatic effects and thromboembolism in transwomen or dyslipidaemia in transmen. There is also a description of the current hormonal regimens used at the largest UK gender identity clinic. The overall safety of these treatments in the context of long-term outcome data is reviewed. © The Author(s) 2015.

Clinical and cost-effectiveness of non-medical prescribing: A systematic review of randomised controlled trials

PubMed Central

Marriott, John; Graham-Clarke, Emma; Shirley, Debra; Rushton, Alison

2018-01-01

Objective To evaluate the clinical and cost-effectiveness of non-medical prescribing (NMP). Design Systematic review. Two reviewers independently completed searches, eligibility assessment and assessment of risk of bias. Data sources Pre-defined search terms/combinations were utilised to search electronic databases. In addition, hand searches of reference lists, key journals and grey literature were employed alongside consultation with authors/experts. Eligibility criteria for included studies Randomised controlled trials (RCTs) evaluating clinical or cost-effectiveness of NMP. Measurements reported on one or more outcome(s) of: pain, function, disability, health, social impact, patient-safety, costs-analysis, quality adjusted life years (QALYs), patient satisfaction, clinician perception of clinical and functional outcomes. Results Three RCTs from two countries were included (n = 932 participants) across primary and tertiary care settings. One RCT was assessed as low risk of bias, one as high risk of bias and one as unclear risk of bias. All RCTs evaluated clinical effectiveness with one also evaluating cost-effectiveness. Clinical effectiveness was evaluated using a range of safety and patient-reported outcome measures. Participants demonstrated significant improvement in outcomes when receiving NMP compared to treatment as usual (TAU) in all RCTs. An associated cost analysis showed NMP to be more expensive than TAU (regression coefficient p = 0.0000), however experimental groups generated increased QALYs compared to TAU. Conclusion Limited evidence with overall unclear risk of bias exists evaluating clinical and cost-effectiveness of NMP across all professions and clinical settings. GRADE assessment revealed moderate quality evidence. Evidence suggests that NMP is safe and can provide beneficial clinical outcomes. Benefits to the health economy remain unclear, with the cost-effectiveness of NMP assessed by a single pilot RCT of low risk of bias. Adequately powered low risk of bias RCTs evaluating clinical and cost effectiveness are required to evaluate NMP across clinical specialities, professions and settings. Registration PROSPERO (CRD42015017212). PMID:29509763

Preclinical and Clinical Studies Demonstrate That the Proprietary Herbal Extract DA-5512 Effectively Stimulates Hair Growth and Promotes Hair Health.

PubMed

Yu, Jae Young; Gupta, Biki; Park, Hyoung Geun; Son, Miwon; Jun, Joon-Ho; Yong, Chul Soon; Kim, Jeong Ah; Kim, Jong Oh

2017-01-01

The proprietary DA-5512 formulation comprises six herbal extracts from traditional oriental plants historically associated with therapeutic and other applications related to hair. Here, we investigated the effects of DA-5512 on the proliferation of human dermal papilla cells (hDPCs) in vitro and on hair growth in C57BL/6 mice and conducted a clinical study to evaluate the efficacy and safety of DA-5512. DA-5512 significantly enhanced the viability of hDPCs in a dose-dependent manner ( p < 0.05), and 100 ppm of DA-5512 and 1  μ M minoxidil (MXD) significantly increased the number of Ki-67-positive cells, compared with the control group ( p < 0.05). MXD (3%) and DA-5512 (1%, 5%) significantly stimulated hair growth and increased the number and length of hair follicles (HFs) versus the controls (each p < 0.05). The groups treated with DA-5512 exhibited hair growth comparable to that induced by MXD. In clinical study, we detected a statistically significant increase in the efficacy of DA-5512 after 16 weeks compared with the groups treated with placebo or 3% MXD ( p < 0.05). In conclusion, DA-5512 might promote hair growth and enhance hair health and can therefore be considered an effective option for treating hair loss.

Interprofessional teamwork skills as predictors of clinical outcomes in a simulated healthcare setting.

PubMed

Shrader, Sarah; Kern, Donna; Zoller, James; Blue, Amy

2013-01-01

Teaching interprofessional (IP) teamwork skills is a goal of interprofessional education. The purpose of this study was to examine the relationship between IP teamwork skills, attitudes and clinical outcomes in a simulated clinical setting. One hundred-twenty health professions students (medicine, pharmacy, physician assistant) worked in interprofessional teams to manage a "patient" in a health care simulation setting. Students completed the Interdisciplinary Education Perception Scale (IEPS) attitudinal survey instrument. Students' responses were averaged by team to create an IEPS attitudes score. Teamwork skills for each team were rated by trained observers using a checklist to calculate a teamwork score (TWS). Clinical outcome scores (COS) were determined by summation of completed clinical tasks performed by the team based on an expert developed checklist. Regression analyses were conducted to determine the relationship of IEPS and TWS with COS. IEPS score was not a significant predictor of COS (p=0.054), but TWS was a significant predictor (p<0.001) of COS. Results suggest that in a simulated clinical setting, students' interprofessional teamwork skills are significant predictors of positive clinical outcomes. Interprofessional curricular models that produce effective teamwork skills can improve student performance in clinical environments and likely improve teamwork practice to positively affect patient care outcomes.

Clinical Effects of Synthetic Cannabinoid Receptor Agonists Compared with Marijuana in Emergency Department Patients with Acute Drug Overdose.

PubMed

Zaurova, Milana; Hoffman, Robert S; Vlahov, David; Manini, Alex F

2016-12-01

Synthetic cannabinoid receptor agonists (SCRAs) are heterogeneous compounds originally intended as probes of the endogenous cannabinoid system or as potential therapeutic agents. We assessed the clinical toxicity associated with recent SCRA use in a large cohort of drug overdose patients. This subgroup analysis of a large (n = 3739) drug overdose cohort study involved consecutive ED patients at two urban teaching hospitals collected between 2009 and 2013. Clinical characteristics of patients with the exposure to SCRAs (SRCA subgroup) were compared with those from patients who smoked traditional cannabinoids (marijuana subgroup). Data included demographics, exposure details, vital signs, mental status, and basic chemistries gathered as part of routine clinical care. Study outcomes included altered mental status and cardiotoxicity. Eighty-seven patients reported exposure to any cannabinoid, of whom 17 reported SCRAs (17 cases, 70 controls, mean age 38.9 years, 77 % males, 31 % Hispanic). There were no significant differences between SRCA and marijuana with respect to demographics (age, gender, and race/ethnicity), exposure history (suicidality, misuse, and intent), vital signs, or serum chemistries. Mental status varied between SRCA and marijuana, with agitation significantly more likely in SCRA subgroup (OR = 3.8, CI = 1.2-11.9). Cardiotoxicity was more pronounced in the SCRA subgroup with dysrhythmia significantly more likely (OR = 9.2, CI = 1.0-108). In the first clinical study comparing the adverse effects of SCRA overdose vs. marijuana controls in an ED population, we found that SCRA overdoses had significantly pronounced neurotoxicity and cardiotoxicity compared with marijuana.

Clinical Objective Dry Eye Tests in a Population of Tannery Workers in North India.

PubMed

Ranjan, Ratnesh; Kushwaha, Raj Nath; Khan, Perwez; Mohan, Shalini; Gupta, Ramesh Chandra

2016-10-01

To analyze the correlation between subjective symptoms and clinical signs of dry eye among tannery workers. In this cross-sectional study, three classic clinical tests, namely the fluorescein tear film break-up time (FTBUT) test, the fluorescein staining (FS) test, and the Schirmer test (ST), were performed to assess the clinical signs of dry eye disease in 246 tanners who were found symptomatic for dry eye in a prior ocular surface disease index survey. All workers were male with a mean age of 35 ± 9 years, and the mean duration of work at tanneries was 8 ± 5 years. Among 246 symptomatic subjects, the FTBUT test, the FS test and the ST were positive in 63.8%, 30.9% and 41.9% workers, respectively. Mean FTBUT and ST scores were 10.6 ± 4.2 seconds and 10.1 ± 7.7mm, respectively. Mean FTBUT for mild, moderate and severe symptom categories differed significantly. Mean ST scores for the mild symptom group were significantly higher than that of the moderate group (p < 0.0001). The FTBUT and ST score showed a strong negative correlation with severity of symptoms (p < 0.0001). A moderate positive correlation was observed between FS positivity and increasing symptom severity (p < 0.0001). The effect of age was insignificant for FTBUT (p = 0.10), while significant for ST score (p < 0.001). The effect of duration of tannery work was significant for both FTBUT and ST scores (p < 0.0001). Clinical tests correlated well with symptom severity among tanners, and a multifactorial etiology is suggested for dry eye diseases.

Evaluation of thermal antinociceptive effects after intramuscular administration of hydromorphone hydrochloride to American kestrels (Falco sparverius)

USGS Publications Warehouse

Guzman, David Sanchez-Migallon; Drazenovich, Tracy L.; Olsen, Glenn H.; Willits, Neil H.; Paul-Murphy, Joanne R.

2013-01-01

Conclusions and Clinical Relevance—Hydromorphone at the doses evaluated significantly increased the thermal nociception threshold for American kestrels for 3 to 6 hours. Additional studies with other types of stimulation, formulations, dosages, routes of administration, and testing times are needed to fully evaluate the analgesic and adverse effects of hydromorphone in kestrels and other avian species and the use of hydromorphone in clinical settings.

Telephone screening, outreach, and care management for depressed workers and impact on clinical and work productivity outcomes: a randomized controlled trial

PubMed Central

Wang, Philip S.; Simon, Gregory E.; Avorn, Jerry; Azocar, Francisca; Ludman, Evette J.; McCulloch, Joyce; Petukhova, Maria Z.; Kessler, Ronald C.

2010-01-01

Context Although guideline-concordant depression treatment is clearly effective, treatment often falls short of evidence-based recommendations. Organized depression care programs significantly improve treatment quality, but employer-purchasers have been slow to demand these programs based on lack of evidence for cost-effectiveness from their perspective. Objective To evaluate the effects of a depression outreach-treatment program on workplace outcomes of concern to employers. Design Randomized controlled trial with allocation concealment and blinded assessment of depression severity and work performance at 6 and 12 months. Setting and Participants Two-stage screening of employees covered by a managed behavioral health plan identified 604 with clinically significant depression (excluding those with lifetime bipolar disorder, substance disorder, recent mental health specialty care, or suicidality). Intervention A telephonic outreach and care management program encouraged workers to enter outpatient treatment (psychotherapy and/or antidepressant medication), monitored treatment quality-continuity, and attempted to improve treatment by giving recommendations to providers. Participants reluctant to enter treatment were offered a structured telephone cognitive-behavioral psychotherapy. Main Outcome Measures Depression severity (Quick Inventory of Depressive Symptomatology, QIDS-SR) and work performance (WHO Health and Productivity Questionnaire, HPQ, a validated self-report instrument assessing job retention, time missed from work, work performance, and critical workplace incidents). Results Combining data across 6-month and 12-month assessments, the intervention group had significantly lower QIDS-SR scores (1.4 relative-odds of recovery), significantly higher job retention (1.7 relative-odds), and significantly more hours worked among the employed (equivalent to an annualized effect of approximately 2.5 weeks of work) than usual care subjects. Conclusions A systematic program to identify depression and promote effective treatment significantly improves not only clinical outcomes but also workplace outcomes. The financial value of the latter to employers in terms of recovered hiring-training and salary costs suggests that many employers would experience a positive return on investment from outreach and enhanced treatment of depressed workers. PMID:17895456

[Dexpanthenol nasal spray as an effective therapeutic principle for treatment of rhinitis sicca anterior].

PubMed

Kehrl, W; Sonnemann, U

1998-09-01

Controlled clinical studies on medical treatment of rhinitis sicca anterior have not yet been published. Therapy recommendations are based on experiences but not on results of controlled clinical studies. The aim of this study was to examine the efficacy and tolerance of a new form of application of Dexpanthenol in physiologic saline solution (Nasicur). A randomized comparison of parallel groups was performed. One group was treated with the nasal spray while the control group received a placebo. The assessment of nasal breathing resistance and the extent of crust formation according to scores were defined as target parameters. Statistical analysis was carried out according to Wilcoxon at alpha < or = 0.05. Forty-eight outpatients diagnosed with rhinitis sicca anterior were included in this study. Twenty-four received the medication, and 29 were treated with a placebo. The superiority of the dexpanthenol nasal spray in comparison to the placebo medication was demonstrated for both target parameters as clinically relevant and statistically significant. The placebo spray showed clinical improvement of the other treatment outcome parameters. Dexpanthenol nasal spray showed no statistically significant difference in comparison to placebo. The clinically proven efficacy is emphasized by good tolerance of both treatments which was validated by the objective rhinoscopy findings. Good compliance was confirmed. The result of the controlled clinical study confirms that the dexpanthenol nasal spray is an effective medicinal treatment of rhinitis sicca anterior and is more effective than common medications.

Comparison of injectable molindone and haloperidol followed by oral dosage forms in acutely ill schizophrenics.

PubMed

Escobar, J I; Mann, J J; Keller, J; Wilkins, J; Mason, B; Mills, M J

1985-08-01

The comparative efficacy of molindone and haloperidol, given by injection for the first 2-3 days of hospitalization and then continued orally for up to 4 weeks, is reported from an ongoing double-blind study. Efficacy and side effects were assessed by the Brief Psychiatric Rating Scale, Clinical Global Impressions, Treatment Emergent Symptom Scale, and Target Symptom Ratings. Analyses based on the first 35 patients who entered the study indicate that both drugs were effective and well tolerated. There were slight advantages for molindone early during the injectable phase of treatment and for haloperidol late during the oral portion of the study, but these differences were not clinically significant. No significant differences in side effects were found between the two drugs.

Histologic effects of resurfacing lasers.

PubMed

Freedman, Joshua R; Greene, Ryan M; Green, Jeremy B

2014-02-01

By utilizing resurfacing lasers, physicians can significantly improve the appearance of sun-damaged skin, scars, and more. The carbon dioxide and erbium:yttrium-aluminum-garnet lasers were the first ablative resurfacing lasers to offer impressive results although these earlier treatments were associated with significant downtime. Later, nonablative resurfacing lasers such as the neodymium:yttrium-aluminum-garnet laser proved effective, after a series of treatments with less downtime, but with more modest results. The theory of fractional photothermolysis has revolutionized resurfacing laser technology by increasing the safety profile of the devices while delivering clinical efficacy. A review of the histologic and molecular consequences of the resurfacing laser-tissue interaction allows for a better understanding of the devices and their clinical effects. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

The effect of a high protein diet on leucine and alanine turnover in acid maltase deficiency.

PubMed Central

Umpleby, A M; Trend, P S; Chubb, D; Conaglen, J V; Williams, C D; Hesp, R; Scobie, I N; Wiles, C M; Spencer, G; Sönksen, P H

1989-01-01

Leucine and alanine production rate was measured in 5 patients with acid maltase deficiency in the postabsorptive state, following 6 months on a normal diet with placebo and 6 months on an isocaloric high protein diet (16-22% protein). Whole body leucine production rate, a measure of protein degradation, expressed in terms of lean body mass was significantly greater than in five control subjects. Following the high protein diet, leucine production rate was decreased in four of the five patients but this was not statistically significant. Alanine production rate expressed in terms of lean body mass was significantly greater than in control subjects. After the high protein diet, alanine production rate and concentration were significantly decreased (p less than 0.05). There were no significant improvements in any of the clinically relevant variables measured in these patients. It is possible that a larger increase in protein intake over a longer time period may have a clinical effect. PMID:2507747

Adherence and retention in clinical trials: a community-based approach.

PubMed

Fouad, Mona N; Johnson, Rhoda E; Nagy, M Christine; Person, Sharina D; Partridge, Edward E

2014-04-01

The Community Health Advisor (CHA) model has been widely used to recruit rural and low-income, mostly African American women into clinical and behavioral research studies. However, little is known about its effectiveness in promoting retention and adherence of such women in clinical trials. The Community-Based Retention Intervention Study evaluated the effectiveness of a community-based intervention strategy using the CHA model and the empowerment theory to improve the retention and adherence of minority and low-income women in clinical trials. The research strategy included the training and use of the volunteer CHAs as research partners. The target population included women participating in the University of Alabama at Birmingham clinical site of the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study (ALTS), a multicenter, randomized clinical trial. Two communities in Jefferson County, Alabama, that were matched according to population demographics were identified and randomly assigned to either an intervention group or a control group. Thirty community volunteers were recruited to be CHAs and to implement the intervention with the ALTS trial participants. In total, 632 ALTS participants agreed to participate in the project, including 359 in the intervention group, which received CHA care, and 273 in the control group, which received standard care. Adherence rates for scheduled clinic visits were significantly higher in the intervention group (80%) compared with the control group (65%; P < .0001). The results indicate that volunteer CHAs can be trained to serve as research partners and can be effective in improving the retention and adherence of minority and low-income women in clinical trials. © 2014 American Cancer Society.

Ward-based, nurse-led, outpatient chest tube management: analysis of impact, cost-effectiveness and patient safety.

PubMed

Tcherveniakov, Peter; De Siqueira, Jonathan; Milton, Richard; Papagiannopoulos, Kostas

2012-06-01

Prolonged drainage and air leaks are recognized complications of elective and acute thoracic surgery and carry significant burden on inpatient stay and outpatient resources. Since 2007, we have run a ward-based, nurse-led clinic for patients discharged with a chest drain in situ. The aim of this study is to assess its cost-effectiveness and safety. We present a retrospective review of the activity of the clinic for a period of 12 months (November 2009-10). An analysis of the gathered data is performed, focusing specifically on the duration of chest tube indwelling, the indications, complications and cost efficiency. The nurse-led clinic was housed in the thoracic ward with no additional fixed costs. Seventy-four patients were reviewed (53 males, 21 females, mean age of 59) and subsequently discharged from the clinic in this time period, accounting for 149 care episodes. Thirty-three (45%) of the patients underwent a video-assisted thoracoscopic surgery procedure, 35 (47%) of them a thoracotomy and 7 (9%) had a bedside chest tube insertion. Following hospital discharge, the chest tubes were removed after a median of 14 days (range 1-82 days). Fifty-eight percent of the patients were reviewed because of a prolonged air leak, 26% for persistent fluid drainage and 16% due to prolonged drainage following evacuation of empyemas. For the care episodes analysed, we estimate that the clinic has generated an income of €24,899 for the department. Hourly staffing costs for the service are significantly lower compared with those of the traditional outpatient clinic: €15 vs. €114. Our results show that a dedicated chest tube monitoring clinic is a safe and efficient alternative to formal outpatient clinic review. It can lead to shorter hospital stays and is cost effective.

Effect of a teleretinal screening program on eye care use and resources.

PubMed

Chasan, Joel E; Delaune, Bill; Maa, April Y; Lynch, Mary G

2014-09-01

Telemedicine is a useful clinical method to extend health care to patients with limited access. Minimal information exists on the subsequent effect of telemedicine activities on eye care resources. To evaluate the effect of a community-based diabetic teleretinal screening program on eye care use and resources. The current study was a retrospective medical record review of patients who underwent diabetic teleretinal screening in the community-based clinics of the Atlanta Veterans Affairs Medical Center from October 1, 2008, through March 31, 2009, and who were referred for an ophthalmic examination in the eye clinic. Clinical medical records were reviewed for a 2-year period after patients were referred from teleretinal screening. The following information was collected for analysis: patient demographics, referral and confirmatory diagnoses, ophthalmology clinic visits, diagnostic procedures, surgical procedures, medications, and spectacle prescriptions. The accuracy between referring and final diagnoses and the eye care resources that were used in the care of referred patients. The most common referral diagnoses were nonmacular diabetic retinopathy (43.2%), nerve-related disease (30.8%), lens or media opacity (19.1%), age-related macular degeneration (12.9%), and diabetic macular edema (5.6%). The percentage of agreement among these 5 visually significant diagnoses was 90.4%, with a total sensitivity of 73.6%. Diabetic macular edema required the greatest number of ophthalmology clinic visits, diagnostic tests, and surgical procedures. Using Medicare cost data estimates, the mean cost incurred during a 2-year period per patient seen in the eye clinic was approximately $1000. Although a teleretinal screening program can be accurate and sensitive for multiple visually significant diagnoses, measurable resource burdens should be anticipated to adequately prepare for the associated increase in clinical care.

Multimodal evaluation and management of children with concussion: using our heads and available evidence.

PubMed

Gioia, Gerard A

2015-01-01

Significant attention has been focused on concussions in children, but a dearth of research evidence exists supporting clinical evaluation and management. The primary objective of this review paper is to describe a multimodal, developmentally adapted, standardized concussion assessment and active rehabilitation approach for children as young as 5 years old. This study reviews the CDC-funded research programme, including the development of tools for post-concussion symptom assessment involving the child and parent, measurement of specific neurocognitive functions and assessment of dynamic cognitive exertional effects. A clinical approach to active, individualized, moderated concussion rehabilitation management is presented, including a 10-step guide to symptom management, with a specific focus on the school challenges faced by the recovering student. To better inform concussion practice across the developmental age spectrum, a significant need exists for further research evidence to refine clinical assessment methods and develop effective treatment approaches.

Multimodal Evaluation and Management of Children with Concussion: Using our heads and available evidence

PubMed Central

Gioia, Gerard A.

2015-01-01

Significant attention has been focused on concussions in children but a dearth of research evidence exists supporting clinical evaluation and management. The primary objective of this review paper is to describe a multimodal, developmentally adapted, standardized concussion assessment and active rehabilitation approach for children as young as age five. We review our CDC-funded research program including the development of tools for post-concussion symptom assessment involving the child and parent, measurement of specific neurocognitive functions, and assessment of dynamic cognitive exertional effects. A clinical approach to active, individualized, moderated concussion rehabilitation management is presented, including a ten step guide to symptom management, with a specific focus on the school challenges faced by the recovering student. To better inform concussion practice across the developmental age spectrum, a significant need exists for further research evidence to refine our clinical assessment methods and develop effective treatment approaches. PMID:25356518

Laboratory mechanical parameters of composite resins and their relation to fractures and wear in clinical trials-A systematic review.

PubMed

Heintze, Siegward D; Ilie, Nicoleta; Hickel, Reinhard; Reis, Alessandra; Loguercio, Alessandro; Rousson, Valentin

2017-03-01

To evaluate a range of mechanical parameters of composite resins and compare the data to the frequency of fractures and wear in clinical studies. Based on a search of PubMed and SCOPUS, clinical studies on posterior composite restorations were investigated with regard to bias by two independent reviewers using Cochrane Collaboration's tool for assessing risk of bias in randomized trials. The target variables were chipping and/or fracture, loss of anatomical form (wear) and a combination of both (summary clinical index). These outcomes were modelled by time and material in a linear mixed effect model including random study and experiment effects. The laboratory data from one test institute were used: flexural strength, flexural modulus, compressive strength, and fracture toughness (all after 24-h storage in distilled water). For some materials flexural strength data after aging in water/saliva/ethanol were available. Besides calculating correlations between clinical and laboratory outcomes, we explored whether a model including a laboratory predictor dichotomized at a cut-off value better predicted a clinical outcome than a linear model. A total of 74 clinical experiments from 45 studies were included involving 31 materials for which laboratory data were also available. A weak positive correlation between fracture toughness and clinical fractures was found (Spearman rho=0.34, p=0.11) in addition to a moderate and statistically significant correlation between flexural strength and clinical wear (Spearman rho=0.46, p=0.01). When excluding those studies with "high" risk of bias (n=18), the correlations were generally weaker with no statistically significant correlation. For aging in ethanol, a very strong correlation was found between flexural strength decrease and clinical index, but this finding was based on only 7 materials (Spearman rho=0.96, p=0.0001). Prediction was not consistently improved with cutoff values. Correlations between clinical and laboratory outcomes were moderately positive with few significant results, fracture toughness being correlated with clinical fractures and flexural strength with clinical wear. Whether artificial aging enhances the prognostic value needs further investigations. Copyright © 2016 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Use of handheld computers in clinical practice: a systematic review.

PubMed

Mickan, Sharon; Atherton, Helen; Roberts, Nia Wyn; Heneghan, Carl; Tilson, Julie K

2014-07-06

Many healthcare professionals use smartphones and tablets to inform patient care. Contemporary research suggests that handheld computers may support aspects of clinical diagnosis and management. This systematic review was designed to synthesise high quality evidence to answer the question; Does healthcare professionals' use of handheld computers improve their access to information and support clinical decision making at the point of care? A detailed search was conducted using Cochrane, MEDLINE, EMBASE, PsycINFO, Science and Social Science Citation Indices since 2001. Interventions promoting healthcare professionals seeking information or making clinical decisions using handheld computers were included. Classroom learning and the use of laptop computers were excluded. Two authors independently selected studies, assessed quality using the Cochrane Risk of Bias tool and extracted data. High levels of data heterogeneity negated statistical synthesis. Instead, evidence for effectiveness was summarised narratively, according to each study's aim for assessing the impact of handheld computer use. We included seven randomised trials investigating medical or nursing staffs' use of Personal Digital Assistants. Effectiveness was demonstrated across three distinct functions that emerged from the data: accessing information for clinical knowledge, adherence to guidelines and diagnostic decision making. When healthcare professionals used handheld computers to access clinical information, their knowledge improved significantly more than peers who used paper resources. When clinical guideline recommendations were presented on handheld computers, clinicians made significantly safer prescribing decisions and adhered more closely to recommendations than peers using paper resources. Finally, healthcare professionals made significantly more appropriate diagnostic decisions using clinical decision making tools on handheld computers compared to colleagues who did not have access to these tools. For these clinical decisions, the numbers need to test/screen were all less than 11. Healthcare professionals' use of handheld computers may improve their information seeking, adherence to guidelines and clinical decision making. Handheld computers can provide real time access to and analysis of clinical information. The integration of clinical decision support systems within handheld computers offers clinicians the highest level of synthesised evidence at the point of care. Future research is needed to replicate these early results and to identify beneficial clinical outcomes.

Use of handheld computers in clinical practice: a systematic review

PubMed Central

2014-01-01

Background Many healthcare professionals use smartphones and tablets to inform patient care. Contemporary research suggests that handheld computers may support aspects of clinical diagnosis and management. This systematic review was designed to synthesise high quality evidence to answer the question; Does healthcare professionals’ use of handheld computers improve their access to information and support clinical decision making at the point of care? Methods A detailed search was conducted using Cochrane, MEDLINE, EMBASE, PsycINFO, Science and Social Science Citation Indices since 2001. Interventions promoting healthcare professionals seeking information or making clinical decisions using handheld computers were included. Classroom learning and the use of laptop computers were excluded. Two authors independently selected studies, assessed quality using the Cochrane Risk of Bias tool and extracted data. High levels of data heterogeneity negated statistical synthesis. Instead, evidence for effectiveness was summarised narratively, according to each study’s aim for assessing the impact of handheld computer use. Results We included seven randomised trials investigating medical or nursing staffs’ use of Personal Digital Assistants. Effectiveness was demonstrated across three distinct functions that emerged from the data: accessing information for clinical knowledge, adherence to guidelines and diagnostic decision making. When healthcare professionals used handheld computers to access clinical information, their knowledge improved significantly more than peers who used paper resources. When clinical guideline recommendations were presented on handheld computers, clinicians made significantly safer prescribing decisions and adhered more closely to recommendations than peers using paper resources. Finally, healthcare professionals made significantly more appropriate diagnostic decisions using clinical decision making tools on handheld computers compared to colleagues who did not have access to these tools. For these clinical decisions, the numbers need to test/screen were all less than 11. Conclusion Healthcare professionals’ use of handheld computers may improve their information seeking, adherence to guidelines and clinical decision making. Handheld computers can provide real time access to and analysis of clinical information. The integration of clinical decision support systems within handheld computers offers clinicians the highest level of synthesised evidence at the point of care. Future research is needed to replicate these early results and to identify beneficial clinical outcomes. PMID:24998515

Exploring the use of Option Grid™ patient decision aids in a sample of clinics in Poland.

PubMed

Scalia, Peter; Elwyn, Glyn; Barr, Paul; Song, Julia; Zisman-Ilani, Yaara; Lesniak, Monika; Mullin, Sarah; Kurek, Krzysztof; Bushell, Matt; Durand, Marie-Anne

2018-05-29

Research on the implementation of patient decision aids to facilitate shared decision making in clinical settings has steadily increased across Western countries. A study which implements decision aids and measures their impact on shared decision making has yet to be conducted in the Eastern part of Europe. To study the use of Option Grid TM patient decision aids in a sample of Grupa LUX MED clinics in Warsaw, Poland, and measure their impact on shared decision making. We conducted a pre-post interventional study. Following a three-month period of usual care, clinicians from three Grupa LUX MED clinics received a one-hour training session on how to use three Option Grid TM decision aids and were provided with copies for use for four months. Throughout the study, all eligible patients were asked to complete the three-item CollaboRATE patient-reported measure of shared decision making after their clinical encounter. CollaboRATE enables patients to assess the efforts clinicians make to: (i) inform them about their health issues; (ii) listen to 'what matters most'; (iii) integrate their treatment preference in future plans. A Hierarchical Logistic Regression model was performed to understand which variables had an effect on CollaboRATE. 2,048 patients participated in the baseline phase; 1,889 patients participated in the intervention phase. Five of the thirteen study clinicians had a statistically significant increase in their CollaboRATE scores (p<.05) when comparing baseline phase to intervention phase. All five clinicians were located at the same clinic, the only clinic where an overall increase (non-significant) in the mean CollaboRATE top score percentage occurred from baseline phase (M=60 %, SD=0.49; 95 % CI [57-63 %]) to intervention phase (M=62 %, SD=0.49; 95% CI [59-65%]). Only three of those five clinicians who had a statistically significant increase had a clinically significant difference. The implementation of Option Grid TM helped some clinicians practice shared decision making as reflected in CollaboRATE scores, but most clinicians did not have a significant increase in their scores. Our study indicates that the effect of these interventions may be dependent on clinic contexts and clinician engagement. Copyright © 2018. Published by Elsevier GmbH.

The translation of product concept to bone products: a partnership of therapeutic effectiveness and commercialization.

PubMed

Ratcliffe, Anthony

2011-12-01

The fields of tissue engineering and regenerative medicine have the capacity to substantially impact clinical care through the introduction of new products that can address unmet clinical needs, or significantly improve on present therapies. These products will be developed through the demonstration of therapeutic effectiveness, adequate safety, and meeting regulatory requirements. The technology used in the product will dictate the product development and manufacturing costs; the regulatory pathway; and the time taken to complete clinical trials, gain regulatory approval, and become commercialized. A comparison of the required investment of time and funds, with the potential revenue generated, allows for a determination of the likely commercialization opportunity. Ultimately, the long-term success of a product will be dependent on its clinical effectiveness and commercial viability. © Mary Ann Liebert, Inc.

Combining novel technologies with improved logistics to reduce hemodialysis vascular access dysfunction.

PubMed

Roy-Chaudhury, P; Lee, T; Duncan, H; El-Khatib, M

2009-01-01

Hemodialysis (HD) vascular access dysfunction is currently a huge clinical problem for which there are no effective therapies. There are, however, a number of promising technologies that are currently at the experimental or clinical trial stage. We believe that the application of these novel technologies in combination with better clinical protocols for vascular access care could significantly reduce the current problems associated with HD vascular access.

Evaluating the Utility of a Structured Clinical Protocol for Reducing the Impact of Behavioural and Psychological Symptoms of Dementia in Progressive Neurological Diseases: A Pilot Study.

PubMed

Ryan, Nicholas P; Scott, Laura; McPhee, Maryanne; Mathers, Susan; Davis, Marie-Claire; Maule, Roxanne; Fisher, Fiona

2018-01-01

Behavioural and psychological symptoms of dementia (BPSD) cause significant distress to both aged care residents and staff. Despite the high prevalence of BPSD in progressive neurological diseases (PNDs) such as multiple sclerosis, Huntington's disease, and Parkinson's disease, the utility of a structured clinical protocol for reducing BPSD has not been systematically evaluated in PND populations. Staff ( n = 51) and individuals with a diagnosis of PND ( n = 13) were recruited into the study, which aimed to evaluate the efficacy of a PND-specific structured clinical protocol for reducing the impact of BPSD in residential aged care (RAC) and specialist disability accommodation (SDA) facilities. Staff were trained in the clinical protocol through face-to-face workshops, which were followed by 9 weeks of intensive clinical supervision to a subset of staff ("behaviour champions"). Staff and resident outcome measures were administered preintervention and immediately following the intervention. The primary outcome was frequency and severity of BPSD, measured using the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH). The secondary outcome was staff coping assessed using the Strain in Dementia Care Scale (SDCS). In SDA, significant reductions in staff ratings of job-related stress were observed alongside a statistically significant decrease in BPSD from T1 to T2. In RAC, there was no significant time effect for BPSD or staff coping; however, a medium effect size was observed for staff job stress. Staff training and clinical support in the use of a structured clinical protocol for managing BPSD were linked to reductions in staff job stress, which may in turn increase staff capacity to identify indicators of resident distress and respond accordingly. Site variation in outcomes may relate to organisational and workforce-level barriers that may be unique to the RAC context and should be systematically addressed in future RCT studies of larger PND samples.

Propofol interruption of ECT seizure to reduce side-effects: a pilot study.

PubMed

Warnell, Ronald L; Swartz, Conrad M; Thomson, Alice

2010-01-30

Fifteen depressed subjects received six bitemporal electroconvulsive therapy (ECT) treatments under etomidate anesthesia. They were randomized to blindly either receive propofol 0.5mg/kg 15s post-stimulus or not. Propofol infusion significantly prevented long seizures, and prevented cognitive decrements in most neuropsychological tests, several significantly. Propofol interruption may clinically help reduce ECT side-effects.

Evaluation of increased milking frequency as an additional treatment for cows with clinical mastitis.

PubMed

Krömker, Volker; Zinke, Claudia; Paduch, Jan-Hendrik; Klocke, Doris; Reimann, Anette; Eller, Georg

2010-02-01

This field study focused on the possible effects of increased milking frequency (milking four times a day in comparison with milking twice a day) on clinical and bacteriological cure rates of clinical, antibiotically treated mastitis cases. Parameters tested were clinical, microbiological and full (cytomicrobiological) cure as well as the development of milk yield after the clinical mastitis episode. Cows from a large dairy herd meeting the study criteria (n=93) were assigned to two treatment groups by a systematic randomization scheme (blocked by body temperature <=or >39.5 degrees C). Both groups were randomly divided by experimental treatments: a) antibiotic intramammary treatment and milking 2-times a day; b) antibiotic intramammary treatment and milking 4-times a day. Treatments were initiated before the culture results were known. Cows were surveyed and evaluated on days 1-6, 24 and 31. No significant differences between treatment and control groups regarding clinical cure, microbiological cure, full cure and milk production could be established. Applying a 4-times a day milking regime did not lead to any significant effect, either positive or negative. Therefore, the results suggest that milking 4-times a day as a supporting therapy for mild, moderate and severe antimicrobially treated mastitis cases cannot be recommended.

Is ginger beneficial for nausea and vomiting? An update of the literature.

PubMed

Marx, Wolfgang; Kiss, Nicole; Isenring, Liz

2015-06-01

Nausea and vomiting can pose a significant burden to patients in a variety of clinical settings. Previous evidence suggests that ginger may be an effective treatment for these symptoms; however, current evidence has been mixed. This article discusses recent clinical trials that have investigated ginger as a treatment for multiple types of nausea and vomiting. In addition, the potential mechanisms of action of ginger will be discussed. This article identified nine studies and seven reviews that investigated ginger for morning sickness, postoperative nausea and vomiting, chemotherapy-induced, and antiretroviral-induced nausea and vomiting. All studies reported that ginger provided a significant reduction in nausea and vomiting; however, the clinical relevance of some studies is less certain. Common limitations within the literature include the lack of standardized extracts, poorly controlled or blinded studies, and limited sample size. In addition, recent evidence has provided further support for 5-HT3 receptor antagonism as a mechanism by which ginger may exert its potentially beneficial effect on nausea and vomiting. The results of studies in this article suggest that ginger is a promising treatment for nausea and vomiting in a variety of clinical settings and possesses a clinically relevant mechanism. However, further studies are required to address the limitations in the current clinical literature before firm recommendations for its use can be made.

Marijuana abstinence effects in marijuana smokers maintained in their home environment.

PubMed

Budney, A J; Hughes, J R; Moore, B A; Novy, P L

2001-10-01

Although withdrawal symptoms are commonly reported by persons seeking treatment for marijuana dependence, the validity and clinical significance of a marijuana withdrawal syndrome has not been established. This controlled outpatient study examined the reliability and specificity of the abstinence effects that occur when daily marijuana users abruptly stop smoking marijuana. Twelve daily marijuana smokers were assessed on 16 consecutive days during which they smoked marijuana as usual (days 1-5), abstained from smoking marijuana (days 6-8), returned to smoking marijuana (days 9-13), and again abstained from smoking marijuana (days 14-16). An overall measure of withdrawal discomfort increased significantly during the abstinence phases and returned to baseline when marijuana smoking resumed. Craving for marijuana, decreased appetite, sleep difficulty, and weight loss reliably changed across the smoking and abstinence phases. Aggression, anger, irritability, restlessness, and strange dreams increased significantly during one abstinence phase, but not the other. Collateral observers confirmed participant reports of these symptoms. This study validated several specific effects of marijuana abstinence in heavy marijuana users, and showed they were reliable and clinically significant. These withdrawal effects appear similar in type and magnitude to those observed in studies of nicotine withdrawal.

A randomized controlled trial of Kundalini yoga in mild cognitive impairment.

PubMed

Eyre, Harris A; Siddarth, Prabha; Acevedo, Bianca; Van Dyk, Kathleen; Paholpak, Pattharee; Ercoli, Linda; St Cyr, Natalie; Yang, Hongyu; Khalsa, Dharma S; Lavretsky, Helen

2017-04-01

Global population aging will result in increasing rates of cognitive decline and dementia. Thus, effective, low-cost, and low side-effect interventions for the treatment and prevention of cognitive decline are urgently needed. Our study is the first to investigate the effects of Kundalini yoga (KY) training on mild cognitive impairment (MCI). Older participants (≥55 years of age) with MCI were randomized to either a 12-week KY intervention or memory enhancement training (MET; gold-standard, active control). Cognitive (i.e. memory and executive functioning) and mood (i.e. depression, apathy, and resilience) assessments were administered at baseline, 12 weeks and 24 weeks. At baseline, 81 participants had no significant baseline group differences in clinical or demographic characteristics. At 12 weeks and 24 weeks, both KY and MET groups showed significant improvement in memory; however, only KY showed significant improvement in executive functioning. Only the KY group showed significant improvement in depressive symptoms and resilience at week 12. KY group showed short- and long-term improvements in executive functioning as compared to MET, and broader effects on depressed mood and resilience. This observation should be confirmed in future clinical trials of yoga intervention for treatment and prevention of cognitive decline (NCT01983930).

Relation between cannabis use and subcortical volumes in people at clinical high risk of psychosis

PubMed Central

Buchy, Lisa; Mathalon, Daniel H.; Cannon, Tyrone D.; Cadenhead, Kristin S.; Cornblatt, Barbara A.; McGlashan, Thomas H.; Perkins, Diana O.; Seidman, Larry J.; Tsuang, Ming T.; Walker, Elaine F.; Woods, Scott W.; Bearden, Carrie E.; Addington, Jean

2016-01-01

Among people at genetic risk of schizophrenia, those who use cannabis show smaller thalamic and hippocampal volumes. We evaluated this relationship in people at clinical high risk (CHR) of psychosis. The Alcohol and Drug Use Scale was used to identify 132 CHR cannabis users, the majority of whom were non-dependent cannabis users, 387 CHR non-users, and 204 healthy control non-users, and all participants completed magnetic resonance imaging scans. Volumes of the thalamus, hippocampus and amygdala were extracted with FreeSurfer, and compared across groups. Comparing all CHR participants with healthy control participants revealed no significant differences in volumes of any ROI. However, when comparing CHR users to CHR non-users, a significant ROI × Cannabis group effect emerged: CHR users showed significantly smaller amygdala compared to CHR non-users. However, when limiting analysis to CHR subjects who reported using alcohol at a ‘use without impairment’ severity level, the amygdala effect was non-significant; rather, smaller hippocampal volumes were seen in CHR cannabis users compared to non-users. Controlling statistically for effects of alcohol and tobacco use rendered all results non-significant. These results highlight the importance of controlling for residual confounding effects of other substance use when examining the relationship between cannabis use and neural structure. PMID:27289213

The genetic basis for survivorship in coronary artery disease

PubMed Central

Dungan, Jennifer R.; Hauser, Elizabeth R.; Qin, Xuejun; Kraus, William E.

2013-01-01

Survivorship is a trait characterized by endurance and virility in the face of hardship. It is largely considered a psychosocial attribute developed during fatal conditions, rather than a biological trait for robustness in the context of complex, age-dependent diseases like coronary artery disease (CAD). The purpose of this paper is to present the novel phenotype, survivorship in CAD as an observed survival advantage concurrent with clinically significant CAD. We present a model for characterizing survivorship in CAD and its relationships with overlapping time- and clinically-related phenotypes. We offer an optimal measurement interval for investigating survivorship in CAD. We hypothesize genetic contributions to this construct and review the literature for evidence of genetic contribution to overlapping phenotypes in support of our hypothesis. We also present preliminary evidence of genetic effects on survival in people with clinically significant CAD from a primary case-control study of symptomatic coronary disease. Identifying gene variants that confer improved survival in the context of clinically appreciable CAD may improve our understanding of cardioprotective mechanisms acting at the gene level and potentially impact patients clinically in the future. Further, characterizing other survival-variant genetic effects may improve signal-to-noise ratio in detecting gene associations for CAD. PMID:24143143

The "hospital central laboratory": automation, integration and clinical usefulness.

PubMed

Zaninotto, Martina; Plebani, Mario

2010-07-01

Recent technological developments in laboratory medicine have led to a major challenge, maintaining a close connection between the search of efficiency through automation and consolidation and the assurance of effectiveness. The adoption of systems that automate most of the manual tasks characterizing routine activities has significantly improved the quality of laboratory performance; total laboratory automation being the paradigm of the idea that "human-less" robotic laboratories may allow for better operation and insuring less human errors. Furthermore, even if ongoing technological developments have considerably improved the productivity of clinical laboratories as well as reducing the turnaround time of the entire process, the value of qualified personnel remains a significant issue. Recent evidence confirms that automation allows clinical laboratories to improve analytical performances only if trained staff operate in accordance with well-defined standard operative procedures, thus assuring continuous monitoring of the analytical quality. In addition, laboratory automation may improve the appropriateness of test requests through the use of algorithms and reflex testing. This should allow the adoption of clinical and biochemical guidelines. In conclusion, in laboratory medicine, technology represents a tool for improving clinical effectiveness and patient outcomes, but it has to be managed by qualified laboratory professionals.

The effectiveness of a simulated scenario to teach nursing students how to perform a bed bath: A randomized clinical trial.

PubMed

Miranda, Renata Pinto Ribeiro; de Cássia Lopes Chaves, Érika; Silva Lima, Rogério; Braga, Cristiane Giffoni; Simões, Ivandira Anselmo Ribeiro; Fava, Silvana Maria Coelho Leite; Iunes, Denise Hollanda

2017-10-01

Simulation allows students to develop several skills during a bed bath that are difficult to teach only in traditional classroom lectures, such as problem-solving, student interactions with the simulator (patient), reasoning in clinical evaluations, evaluation of responses to interventions, teamwork, communication, security and privacy. This study aimed to evaluate the effectiveness of a simulated bed bath scenario on improving cognitive knowledge, practical performance and satisfaction among nursing students. Randomized controlled clinical trial. Nursing students that were in the fifth period from two educational institutions in Brazil. Nursing students (n=58). The data were collected using the assessments of cognitive knowledge, practical performance and satisfaction were made through a written test about bed baths, an Objective Structured Clinical Examination (OSCE) and a satisfaction questionnaire. We identified that the acquisition and assimilation of cognitive knowledge was significantly higher in the simulation group (p=0.001). The performance was similar in both groups regardless of the teaching strategy (p=0.435). At follow-up, the simulation group had significantly more satisfaction with the teaching method than the control group (p=0.007). The teaching strategy based on a simulated scenario of a bed bath proved to be effective for the acquisition of cognitive knowledge regarding bed baths in clinical practice and improved student satisfaction with the teaching process. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Effect of clomiphene citrate and Dingkun Dan on ovulation induction and clinical pregnancy of polycystic ovary syndrome].

PubMed

Chen, Lan; Tan, Yong; Chen, Shu-Ping

2017-10-01

The evaluation is based on clomiphene citrate (CC)+gonadotropin (Gn), clinical study on CC and Dingkun Dan's treatment on ovulation induction and clinical pregnancy effect of PCOS, and to provide ideas and methods for traditional Chinese medicine assisted reproductive treatment. This study selected 60 PCOS infertility patients treated with ovulation induction in reproductive medicine clinic, Jiangsu Province Hospital of traditional Chinese medicine during 2015-10-01-2017-04-23. They were randomly divided into two groups： Group A (CC+Gn+HCG) and Group B (CC+Gn+Dingkun Dan). These results were observed and compared including cycle ovulation rate, cycle cancellation rate, cycle pregnancy rate, cumulative pregnancy rate, endometrial thickness, duration of Gn, total amount of Gn, the occurring rate of luteinized unruptured follicle syndrome and ovarian hyperstimulation syndrome. Group A had lower cycle ovulation rate, cycle pregnancy rate, cumulative pregnancy rate and endometrial thickness, compared with Group B, the difference was statistically significant(P＜0.05). However, Group A had higher cycle cancellation rate, duration of Gn and total amount of Gn, compared with Group B, the difference was statistically significant(P＜0.05). In this study, no case of LUFS or OHSS was found in all patients. CC and Dingkun Dan had the effect of promoting ovulation on PCOS infertility patients, and CC+Gn+Dingkun Dan could elevate clinical pregnancy rate. Copyright© by the Chinese Pharmaceutical Association.

Investigating the Implications of a Variable RBE on Proton Dose Fractionation Across a Clinical Pencil Beam Scanned Spread-Out Bragg Peak

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

Marshall, Thomas I.; Chaudhary, Pankaj; Michaelidesová, Anna

2016-05-01

Purpose: To investigate the clinical implications of a variable relative biological effectiveness (RBE) on proton dose fractionation. Using acute exposures, the current clinical adoption of a generic, constant cell killing RBE has been shown to underestimate the effect of the sharp increase in linear energy transfer (LET) in the distal regions of the spread-out Bragg peak (SOBP). However, experimental data for the impact of dose fractionation in such scenarios are still limited. Methods and Materials: Human fibroblasts (AG01522) at 4 key depth positions on a clinical SOBP of maximum energy 219.65 MeV were subjected to various fractionation regimens with an interfractionmore » period of 24 hours at Proton Therapy Center in Prague, Czech Republic. Cell killing RBE variations were measured using standard clonogenic assays and were further validated using Monte Carlo simulations and parameterized using a linear quadratic formalism. Results: Significant variations in the cell killing RBE for fractionated exposures along the proton dose profile were observed. RBE increased sharply toward the distal position, corresponding to a reduction in cell sparing effectiveness of fractionated proton exposures at higher LET. The effect was more pronounced at smaller doses per fraction. Experimental survival fractions were adequately predicted using a linear quadratic formalism assuming full repair between fractions. Data were also used to validate a parameterized variable RBE model based on linear α parameter response with LET that showed considerable deviations from clinically predicted isoeffective fractionation regimens. Conclusions: The RBE-weighted absorbed dose calculated using the clinically adopted generic RBE of 1.1 significantly underestimates the biological effective dose from variable RBE, particularly in fractionation regimens with low doses per fraction. Coupled with an increase in effective range in fractionated exposures, our study provides an RBE dataset that can be used by the modeling community for the optimization of fractionated proton therapy.« less

Effectiveness of betahistine (48 mg/day) in patients with vestibular vertigo during routine practice: The VIRTUOSO study

PubMed Central

Parfenov, Vladimir A.; Golyk, Volodymyr A.; Matsnev, Eduard I.; Morozova, Svetlana V.; Melnikov, Oleg A.; Antonenko, Ludmila M.; Sigaleva, Elena E.; Situkho, Maksym I.; Asaulenko, Olena I.; Popovych, Vasyl I.; Zamergrad, Maxim V.

2017-01-01

Background Vestibular vertigo is associated with substantially reduced quality of life. Betahistine is effective in improving vertigo-associated symptoms, with longer treatment periods leading to greater improvements; however, it is not known whether these effects persist after treatment cessation. Methods VIRTUOSO was a prospective, multinational, non-comparative, post-marketing observational programme investigating the effectiveness of betahistine (48 mg/day) and the course of vertigo after the discontinuation of treatment. Patients with vestibular vertigo who were prescribed 48 mg/day betahistine were enrolled in Russia and Ukraine. Treatment duration was up to 2 months, and patients were followed up for 2 months after discontinuation of betahistine. Efficacy endpoints included clinical response (assessed by change in vertigo severity), monthly attack frequency, and physician and patient grading of overall clinical response and improvement of vertigo-associated symptoms. Results Overall, 309 patients were enrolled and 305 completed the study. Clinical response was rated as good, very good or excellent in 74.1% of patients at end of treatment, with vertigo severity significantly decreased from baseline (p < 0.001). Monthly vertigo attack frequency decreased significantly during the 2 months of treatment (p < 0.001 from baseline) and further decreased during the 2-month follow-up (p < 0.001 from end of treatment). Overall, clinical response was graded as good or excellent by 94.4% of physicians and 95.4% of patients. Clinical improvement was considered either good or excellent by 82.6–90.5% of physicians and patients for nausea, vomiting and faintness. Only one adverse event was reported, with no serious adverse events. Conclusion Our findings suggest that betahistine (48 mg/day) therapy is effective in treating vertigo in routine clinical settings. The observed effects persisted for 2 months after treatment cessation, suggesting that betahistine may facilitate lasting vestibular compensation. PMID:28358888

Clinical phenotype of bipolar disorder with comorbid binge eating disorder

PubMed Central

McElroy, Susan L.; Crow, Scott; Biernacka, Joanna M.; Winham, Stacey; Geske, Jennifer; Cuellar Barboza, Alfredo B.; Prieto, Miguel L.; Chauhan, Mohit; Seymour, Lisa R.; Mori, Nicole; Frye, Mark A.

2017-01-01

Background To explore the relationship between binge eating disorder (BED) and obesity in patients with bipolar disorder (BP). Methods 717 patients participating in the Mayo Clinic Bipolar Biobank completed structured diagnostic interviews and questionnaires for demographic and illness-related variables. They also had weight and height measured to determine body mass index (BMI). The effects of BED and obesity (BMI≥30 kg/m2), as well as their interaction, were assessed on one measure of general medical burden and six proxies of psychiatric illness burden. Results 9.5% of patients received a clinical diagnosis of BED and 42.8% were obese. BED was associated with a significantly elevated BMI. Both BED and obesity were associated with greater psychiatric and general illness burden, but illness burden profiles differed. After controlling for obesity, BED was associated with suicidality, psychosis, mood instability, anxiety disorder comorbidity, and substance abuse comorbidity. After controlling for BED status, obesity was associated with greater general medical comorbidity, but lower substance abuse comorbidity. There were no significant interaction effects between obesity and BED, or BMI and BED, on any illness burden outcome. Limitations There may have been insufficient power to detect interactions between BED and obesity. Conclusions: Among patients with BP, BED and obesity are highly prevalent and correlated, but associated with different profiles of enhanced illness burden. As the association of BED with greater psychiatric illness burden remained significant even after accounting for the effect of obesity, BP with BED may represent a clinically important sub-phenotype. PMID:23742827

Effects of a work-based critical reflection program for novice nurses.

PubMed

Kim, Yeon Hee; Min, Ja; Kim, Soon Hee; Shin, Sujin

2018-02-27

Critical reflection is effective in improving students' communication abilities and confidence. The aim of this study was to evaluate the effectiveness of a work-based critical reflection program to enhance novice nurses' clinical critical-thinking abilities, communication competency, and job performance. The present study used a quasi-experimental design. From October 2014 to August 2015, we collected data from 44 novice nurses working in an advanced general hospital in S city in Korea. Nurses in the experimental group participated in a critical reflection program for six months. Outcome variables were clinical critical-thinking skills, communication abilities, and job performance. A non-parametric Mann-Whitney U-test and a Wilcoxon rank sum test were selected to evaluate differences in mean ranks and to assess the null hypothesis that the medians were equal across the groups. The results showed that the clinical critical-thinking skills of those in the experimental group improved significantly (p = 0.003). The differences in mean ranks of communication ability between two groups was significantly statistically different (p = 0.028). Job performance improved significantly in both the experimental group and the control group, so there was no statistical difference (p = 0.294). We therefore suggest that a critical reflection program be considered an essential tool for improving critical thinking and communication abilities among novice nurses who need to adapt to the clinical environment as quickly as possible. Further, we suggest conducting research into critical reflection programs among larger and more diverse samples.

Prenatal exposure to Plasmodium falciparum increases frequency and shortens time from birth to first clinical malaria episodes during the first two years of life: prospective birth cohort study.

PubMed

Sylvester, Boniphace; Gasarasi, Dinah B; Aboud, Said; Tarimo, Donath; Massawe, Siriel; Mpembeni, Rose; Swedberg, Gote

2016-07-22

Prenatal exposure to Plasmodium falciparum affects development of protective immunity and susceptibility to subsequent natural challenges with similar parasite antigens. However, the nature of these effects has not been fully elucidated. The aim of this study was to determine the effect of prenatal exposure to P. falciparum on susceptibility to natural malaria infection, with a focus on median time from birth to first clinical malaria episode and frequency of clinical malaria episodes in the first 2 years of life. A prospective birth cohort study was conducted in Rufiji district in Tanzania, between January 2013 and December 2015. Infants born to mothers with P. falciparum in the placenta at time of delivery were defined as exposed, and infants born to mothers without P. falciparum parasites in placenta were defined as unexposed. Placental infection was established by histological techniques. Out of 206 infants recruited, 41 were in utero exposed to P. falciparum and 165 infants were unexposed. All infants were monitored for onset of clinical malaria episodes in the first 2 years of life. The outcome measure was time from birth to first clinical malaria episode, defined by fever (≥37 °C) and microscopically determined parasitaemia. Median time to first clinical malaria episode between exposed and unexposed infants was assessed using Kaplan-Meier survival analysis and comparison was done by log rank. Association of clinical malaria episodes with prenatal exposure to P. falciparum was assessed by multivariate binary logistic regression. Comparative analysis of mean number of clinical malaria episodes between exposed and unexposed infants was done using independent sample t test. The effect of prenatal exposure to P. falciparum infection on clinical malaria episodes was statistically significant (Odds Ratio of 4.79, 95 % CI 2.21-10.38, p < 0.01) when compared to other confounding factors. Median time from birth to first clinical malaria episode for exposed and unexposed infants was 32 weeks (95 % CI 30.88-33.12) and 37 weeks (95 % CI 35.25-38.75), respectively, and the difference was statistically significant (p = 0.003). The mean number of clinical malaria episodes in exposed and unexposed infants was 0.51 and 0.30 episodes/infant, respectively, and the difference was statistically significant (p = 0.038). Prenatal exposure to P. falciparum shortens time from birth to first clinical malaria episode and increases frequency of clinical malaria episodes in the first 2 years of life.

Systemic effects induced by intralesional injection of ω-conotoxin MVIIC after spinal cord injury in rats

PubMed Central

2014-01-01

Background Calcium channel blockers such as conotoxins have shown a great potential to reduce brain and spinal cord injury. MVIIC neuroprotective effects analyzed in in vitro models of brain and spinal cord ischemia suggest a potential role of this toxin in preventing injury after spinal cord trauma. However, previous clinical studies with MVIIC demonstrated that clinical side effects might limit the usefulness of this drug and there is no research on its systemic effects. Therefore, the present study aimed to investigate the potential toxic effects of MVIIC on organs and to evaluate clinical and blood profiles of rats submitted to spinal cord injury and treated with this marine toxin. Rats were treated with placebo or MVIIC (at doses of 15, 30, 60 or 120 pmol) intralesionally following spinal cord injury. Seven days after the toxin administration, kidney, brain, lung, heart, liver, adrenal, muscles, pancreas, spleen, stomach, and intestine were histopathologically investigated. In addition, blood samples collected from the rats were tested for any hematologic or biochemical changes. Results The clinical, hematologic and biochemical evaluation revealed no significant abnormalities in all groups, even in high doses. There was no significant alteration in organs, except for degenerative changes in kidneys at a dose of 120 pmol. Conclusions These findings suggest that MVIIC at 15, 30 and 60 pmol are safe for intralesional administration after spinal cord injury and could be further investigated in relation to its neuroprotective effects. However, 120 pmol doses of MVIIC may provoke adverse effects on kidney tissue. PMID:24739121

Technician Consistency in Specular Microscopy Measurements: A "Real-World" Retrospective Analysis of a United States Eye Bank.

PubMed

Rand, Gabriel M; Kwon, Ji Won; Gore, Patrick K; McCartney, Mitchell D; Chuck, Roy S

2017-10-01

To quantify consistency of endothelial cell density (ECD) measurements among technicians in a single US eye bank operating under typical operating conditions. In this retrospective analysis of 51 microscopy technicians using a semiautomated counting method on 35,067 eyes from July 2007 to May 2015, technician- and date-related marginal ECD effects were calculated using linear regression models. ECD variance was correlated with the number of specular microscopy technicians. Technician mean ECDs ranged from 2386 ± 431 to 3005 ± 560 cells/mm. Nine technicians had statistically and clinically significant marginal effects. Annual mean ECDs adjusted for changes in technicians ranged from 2422 ± 433 to 2644 ± 430 cells/mm. The period of 2007 to 2009 had statistically and clinically significant marginal effects. There was a nonstatistically significant association between the number of technicians and ECD standard deviation. There was significant ECD variability associated with specular microscopy technicians and with the date of measurement. We recommend that eye banks collect data related to laboratory factors that have been shown to influence ECD variability.

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

PubMed

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

2011-12-01

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

Cervical Spinal Clearance: A Prospective Western Trauma Association Multi-Institutional Trial

PubMed Central

Inaba, Kenji; Byerly, Saskya; Bush, Lisa D.; Martin, Matthew J.; Martin, David T.; Peck, Kimberly A.; Barmparas, Galinos; Bradley, Matthew J.; Hazelton, Joshua P.; Coimbra, Raul; Choudhry, Asad J.; Brown, Carlos V.R.; Ball, Chad G.; Cherry-Bukowiec, Jill R.; Burlew, Clay Cothren; Joseph, Bellal; Dunn, Julie; Minshall, Christian T.; Carrick, Matthew M.; Berg, Gina M.; Demetriades, Demetrios

2016-01-01

Background For blunt trauma patients who have failed the NEXUS low-risk criteria, the adequacy of CT as the definitive imaging modality for clearance remains controversial. The purpose of this study was to prospectively evaluate the accuracy of CT for the detection of clinically significant C-spine injury. Methods Prospective multicenter observational study (09/2013-03/2015), at 18 North American Trauma Centers. All adult (≥18yo) blunt trauma patients underwent a structured clinical examination. NEXUS failures underwent a CT of the C-spine with clinical follow up to discharge. The primary outcome measure was sensitivity and specificity of CT for clinically significant injuries requiring surgical stabilization, halo or cervical-thoracic orthotic (CTO) placement using the gold standard of final diagnosis at the time of discharge, incorporating all imaging and operative findings. Results 10,765 patients met inclusion criteria, 489 (4.5%) were excluded (previous spinal instrumentation or outside hospital transfer). 10,276 patients [4,660 (45.3%) unevaluable/distracting injuries, 5,040 (49.0%) midline C-spine tenderness, 576 (5.6%) neurologic symptoms] were prospectively enrolled: mean age 48.1yo (range 18-110), SBP 138 (SD 26), median GCS 15 (IQR 14,15), ISS 9 (IQR 4,16). Overall, 198 (1.9%) had a clinically significant C-spine injury requiring surgery [153 (1.5%)] or halo [25 (0.2%)] or CTO [20 (0.2%)]. The sensitivity and specificity for clinically significant injury was 98.5% and 91.0% with a NPV of 99.97%. There were 3 (0.03%) false negative CT scans that missed a clinically significant injury, all had a focal neurologic abnormality on their index clinical examination consistent with central cord syndrome and 2 of 3 had severe degenerative disease. Conclusions For patients requiring acute imaging for their C-spine after blunt trauma, CT was effective for ruling out clinically significant injury with a sensitivity of 98.5%. For patients with an abnormal neurologic exam as the trigger for imaging, there is a small but clinically significant incidence of a missed injury and further imaging with MRI is warranted. Level of Evidence Level II, Diagnostic Tests or Criteria PMID:27438681

The effect of platelet-rich plasma on clinical outcomes in lateral epicondylitis.

PubMed

Ahmad, Zafar; Brooks, Roger; Kang, Sertaz-Niel; Weaver, Holly; Nunney, Ian; Tytherleigh-Strong, Graham; Rushton, Neil

2013-11-01

To evaluate the evidence for application of platelet-rich plasma (PRP) in lateral epicondylitis. We carried out a systematic review of the current evidence on the effects of PRP in lateral epicondylitis on clinical outcomes. We performed a comprehensive search of the PubMed, Medline, Cochrane, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase databases using various combinations of the commercial names of each PRP preparation and "lateral epicondylitis" (with its associated terms), looking specifically at human studies. Data validity was assessed and collected on clinical outcome. Nine studies met the inclusion criteria, of which 5 were randomized controlled trials. Two cohort studies showed that PRP improved clinical satisfaction scores. One case-control study showed that PRP yielded a significantly greater improvement in symptoms compared with bupivacaine. Two randomized controlled trials compared the effect of injections of PRP and blood. Only 1 of the studies noted a significant difference at the 6-week time point. Three randomized controlled trials compared corticosteroids with PRP. Two of the smaller trials, which had follow-up periods of 6 weeks and 3 months, showed no significant difference between treatment groups. The largest randomized controlled trial found that PRP had significant benefit compared with corticosteroids with regard to pain and Disabilities of the Arm, Shoulder and Hand scores at 1- and 2-year time points. This review highlights the limited but evolving evidence for the use of PRP in lateral epicondylitis; however, further research is required to understand the concentration and preparation that facilitate the best clinical outcome. Characterizing the timing of the intervention would optimize the health economics behind the decision to treat for the patient and health care provider. Level III, systematic review of Level I to III studies. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Memantine for dementia.

PubMed

Areosa, Sastre A; Sherriff, F

2003-01-01

Alzheimer's disease, vascular and mixed dementia are the three commonest forms of dementia affecting older people. There is evidence that the excitatory activity of L-glutamate plays a role in the pathogenesis of Alzheimer's disease and in the damage from an ischaemic stroke. A low affinity antagonist to N-Methyl-D-aspartate (NMDA) type receptors, such as memantine, may prevent excitatory amino acid neurotoxicity without interfering with the physiological actions of glutamate required for memory and learning. To determine the clinical efficacy and safety of memantine for people with Alzheimer's disease, or vascular or mixed dementia. Trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 15 April 2003 using the terms: memantin*, D-145, DMAA, DRG-0267. All major health care databases and trial databases within the scope of the group are searched regularly to keep this Register up to date. Double-blind, parallel group, placebo-controlled, randomized and unconfounded trials in which memantine was administered to people with dementia. Data were extracted, pooled where possible, and weighted mean differences, standardized mean differences or odds ratios were estimated. Intention-to-treat (ITT) and observed cases (OC) analyses are reported, where data were available. Effect of memantine in patients with moderate to severe Alzheimer's disease: analysis of the change from baseline at 28 weeks gave statistically significant results in favour of memantine for 20 mg/day on cognition (MD: 6.1. 95% CI 2.99 to 9.21, P=0.0001) activities of daily living (MD 2.10, 95% CI 0.46 to 3.74, p=0.01) and in the global clinical impression of change measured by the CIBIC-Plus at 28 weeks (MD -0.30, 95% CI -0.58 to -0.02, p=0.04), in all cases the analysis was the ITT-LOCF population (Reisberg 2000). There were no significant differences between memantine and placebo for the number of drop-outs and total number of adverse effects, but a significant difference in favour of memantine for the number who suffer agitation. Effect of memantine in patients with mild to moderate vascular dementia: analysis of the change from baseline at 28 weeks gave statistically significant results in favour of memantine ( 20 mg/day ) for cognition (MD -2.19, 95% CI -3.16 to -1.21, P<0.0001) but there was no benefit for the clinical impression of change, or for global measures of dementia (MMM300, and MMM500). There were no significant differences between memantine and placebo for the number of drop-outs and total number of adverse effects, but a significant difference in favour of memantine for the number who suffer agitation. Effect of memantine in patients with Alzheimer's disease and vascular dementia at 12 weeks: there was no statistically significant difference between memantine (10 mg/day) and placebo in activities of daily living. There was a benefit in favour of memantine (10 mg/day) compared with placebo at 12 weeks, for the numbers improved in terms of clinical impression of change (60/82 compared with 38/84 - OR 3.30, 95% CI 1.72 to 6.33, P=0.0003) (Winblad 1999). Effect of memantine in patients with vascular dementia, Alzheimer's disease and dementia of non-specified type at 6 weeks: there were beneficial effects on cognition (Ditzler 1991), activities of daily living (Ditzler 1991, Pantev 1993), behaviour (Pantev 1993) and global scales (Gortelmeyer 1992; Pantev 1993; Ditzler 1991) and in global impression of change (Gortelmeyer 1992; Ditzler 1991). There were no significant differences between memantine and placebo for the number of drop-outs and total number of adverse effects, but a significant difference in favour of placebo for the number who suffer restlessness. There is a beneficial effect of memantine (20 mg/day) for patients with moderate to severe Alzheimer disease on cognition and functional decline but not in the clinical impression of change. Patifor patients with moderate to severe Alzheimer disease on cognition and functional decline but not in the clinical impression of change. Patients with mild to moderate vascular dementia receiving memantine 20 mg/day had less cognitive deterioration at 28 weeks but again this effect was not clinically discernible. There is a possible beneficial effect on cognition, function and global scales for memantine at 6 weeks in mixed populations. The drug is well tolerated and the incidence of adverse effects is low. More studies are needed.

The impact of hypnotic suggestibility in clinical care settings.

PubMed

Montgomery, Guy H; Schnur, Julie B; David, Daniel

2011-07-01

Hypnotic suggestibility has been described as a powerful predictor of outcomes associated with hypnotic interventions. However, there have been no systematic approaches to quantifying this effect across the literature. This meta-analysis evaluates the magnitude of the effect of hypnotic suggestibility on hypnotic outcomes in clinical settings. PsycINFO and PubMed were searched from their inception through July 2009. Thirty-four effects from 10 studies and 283 participants are reported. Results revealed a statistically significant overall effect size in the small to medium range (r = .24; 95% Confidence Interval = -0.28 to 0.75), indicating that greater hypnotic suggestibility led to greater effects of hypnosis interventions. Hypnotic suggestibility accounted for 6% of the variance in outcomes. Smaller sample size studies, use of the SHCS, and pediatric samples tended to result in larger effect sizes. The authors question the usefulness of assessing hypnotic suggestibility in clinical contexts.

The impact of hypnotic suggestibility in clinical care settings

PubMed Central

Montgomery, Guy H.; Schnur, Julie B.; David, Daniel

2013-01-01

Hypnotic suggestibility has been described as a powerful predictor of outcomes associated with hypnotic interventions. However, there have been no systematic approaches to quantifying this effect across the literature. The present meta-analysis evaluates the magnitude of the effect of hypnotic suggestibility on hypnotic outcomes in clinical settings. PsycINFO and PubMed were searched from their inception through July 2009. Thirty-four effects from ten studies and 283 participants are reported. Results revealed a statistically significant overall effect size in the small to medium range (r = 0.24; 95% Confidence Interval = −0.28 to 0.75), indicating that greater hypnotic suggestibility led to greater effects of hypnosis interventions. Hypnotic suggestibility accounted for 6% of the variance in outcomes. Smaller sample size studies, use of the SHCS, and pediatric samples tended to result in larger effect sizes. Results question the usefulness of assessing hypnotic suggestibility in clinical contexts. PMID:21644122

[The effect of a scenario-based simulation communication course on improving the communication skills of nurses].

PubMed

Huang, Ya-Hsuan; Hsieh, Suh-Ing; Hsu, Li-Ling

2014-04-01

Limited disease knowledge is frequently the cause of disease-related anxiety in myocardial infarction patients. The ability to communicate effectively serves multiple purposes in the professional nursing practice. By communicating effectively with myocardial infarction patients, nurses may help reduce their anxiety by keeping them well informed about their disease and teaching them self-care strategies. This research evaluates the communication skills of nurses following scenario-based simulation education in the context of communication with myocardial infarction patients. This study used an experimental design and an educational intervention. The target population comprised nurses of medicine (clinical qualified level N to N2 for nursing) working at a municipal hospital in Taipei City, Taiwan. A total 122 participants were enrolled. Stratified block randomization divided participants into an experimental group and a control group. The experimental group received clinical scenario-based simulation education for communication. The control group received traditional class-based education for communication. Both groups received a pre-test and a Communication Skills Checklist post-test assessment. Results were analyzed using SPSS 17.0 for Windows software. A t-test showed significant increases in communication skills (p < .001) in the experimental group and ANCOVA results identified significant between-group differences (p < .001) in communication skills following the education intervention. The results indicate that clinical scenario-based simulation education for communication is significantly more effective than traditional class-based education in enhancing the ability of nurses to communicate effectively with myocardial infarction patients.

Does ethnicity, gender or age of physiotherapy students affect performance in the final clinical placements? An exploratory study.

PubMed

Naylor, Sandra; Norris, Meriel; Williams, Annabel

2014-03-01

To explore demographic differences in awarded marks of the final clinical placement in a physiotherapy undergraduate programme. Retrospective analysis of clinical placement assessment marks. A London university offering clinical placements throughout South East England. 333 physiotherapy students entering physiotherapy training between 2005 to 2009. Marks awarded following assessment using a clinical placement assessment form. The mean mark (SD) for age were standard entry 71 (7.4) vs. mature entry 72 (7.99) (ns); for gender male 72 (8.45) vs. female 71 (7.21) (ns); and ethnicity White British 72 (7.71) vs. ethnic minority 70 (7.01) (p=0.023). No interaction effects were observed between the independent variables and only ethnicity demonstrated a statistically significant effect (mean difference (MD) 2.4% 95%CI 0.5 to 4.3, F=5.24, p=0.023). This difference was maintained in most subcategories. Significant differences were observed for the interpersonal section (MD 2.21% 95%CI 0.14 to 4.28, F=4.409, p=0.03), the clinical reasoning section (MD 2.39% 95%CI 0.53 to 4.25, F=6.37, p=0.012) and the treatment section (MD 2.93 95%CI 1.10 to 4.83, F=9.198, p=0.003). Physiotherapy students from minority ethnic backgrounds were awarded a significantly lower mark than their white majority peers in final clinical placements, although the difference was small. Potential reasons are considered, with the strongest recommendation being for further enquiry into the potential relationship between ethnicity and success in undergraduate physiotherapy education. Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Bupropion for the treatment of apathy in Huntington’s disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial

PubMed Central

Gelderblom, Harald; Wüstenberg, Torsten; McLean, Tim; Mütze, Lisanne; Fischer, Wilhelm; Saft, Carsten; Hoffmann, Rainer; Süssmuth, Sigurd; Schlattmann, Peter; van Duijn, Erik; Landwehrmeyer, Bernhard; Priller, Josef

2017-01-01

Objective To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD). Methods In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy—Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI). Results At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator. Conclusion Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD. Trial registration ClinicalTrials.gov 01914965 PMID:28323838

An intensive time-series evaluation of the effectiveness of cognitive behaviour therapy for hoarding disorder: a 2-year prospective study.

PubMed

Pollock, Lisa; Kellett, Stephen; Totterdell, Peter

2014-01-01

To intensively evaluate the effectiveness of cognitive-behavioural therapy (CBT) for Hoarding Disorder. An ABC with extended follow-up N=1 single-case experimental design (SCED) measured discard incidence/frequency/volume and associated cognitions, behaviours and emotions in a 644-day time series. Following a 4-week baseline (A), CBT was initially delivered via out-patient sessions (B) and then out-patient sessions plus domiciliary visits (C). Total treatment duration was 45 sessions (65 weeks) and follow-up was 4 sessions over 23 weeks. There was a significant increase in frequency and volume of discard, with a reliable and clinically significant reduction in hoarding. The addition of domiciliary visits did not significantly improve discard ability. The clinical utility of domiciliary visits whilst treating of hoarding is discussed and study limitations noted.

Public Reporting of Primary Care Clinic Quality: Accounting for Sociodemographic Factors in Risk Adjustment and Performance Comparison.

PubMed

Wholey, Douglas R; Finch, Michael; Kreiger, Rob; Reeves, David

2018-01-03

Performance measurement and public reporting are increasingly being used to compare clinic performance. Intended consequences include quality improvement, value-based payment, and consumer choice. Unintended consequences include reducing access for riskier patients and inappropriately labeling some clinics as poor performers, resulting in tampering with stable care processes. Two analytic steps are used to maximize intended and minimize unintended consequences. First, risk adjustment is used to reduce the impact of factors outside providers' control. Second, performance categorization is used to compare clinic performance using risk-adjusted measures. This paper examines the effects of methodological choices, such as risk adjusting for sociodemographic factors in risk adjustment and accounting for patients clustering by clinics in performance categorization, on clinic performance comparison for diabetes care, vascular care, asthma, and colorectal cancer screening. The population includes all patients with commercial and public insurance served by clinics in Minnesota. Although risk adjusting for sociodemographic factors has a significant effect on quality, it does not explain much of the variation in quality. In contrast, taking into account the nesting of patients within clinics in performance categorization has a substantial effect on performance comparison.

Tablet splitting: a review of the clinical and economic outcomes and patient acceptance. Second of a 2-part series. Part 1 was published in May 2012 (Consult Pharm 2012;27:239-53).

PubMed

Freeman, Maisha Kelly; White, Whitney; Iranikhah, Maryam

2012-06-01

To describe the clinical outcomes, patient acceptance, and economic effect associated with tablet splitting. PubMed (1966-June 2011) and International Pharmaceutical Abstract (1975-June 2011) searches were conducted using tablet splitting as the search terms. All studies that evaluated the clinical outcome (n = 4), patient acceptance (n = 5), and economic effects (n = 8) of tablet splitting were included. The American Pharmacists Association guidelines, recommendations from the Food and Drug Administration, and clinical trial data were evaluated. The majority of trials conducted evaluating clinical outcomes associated with tablet splitting were evaluated in patients receiving statins and antihypertensives. Clinical outcomes associated with risperidone were assessed. No adverse clinical outcomes were observed with therapy. Most studies evaluating the economic effects of tablet splitting have revealed a cost savings associated with this process; however, many studies were subject to limitations. The first part of this two-part series reviewed the weight and content uniformity in tablet splitting. Tablet splitting does not seem to significantly affect clinical outcomes related to management of hypertension, cholesterol, or psychiatric disorders, nor influence overall patient adherence.

Effect of integrated infectious disease training and on-site support on the management of childhood illnesses in Uganda: a cluster randomized trial.

PubMed

Imani, Peace; Jakech, Brian; Kirunda, Ibrahim; Mbonye, Martin K; Naikoba, Sarah; Weaver, Marcia R

2015-08-28

The Integrated Infectious Disease Capacity-Building Evaluation (IDCAP) was designed to test the effects of two interventions, Integrated Management of Infectious Disease (IMID) training and on-site support (OSS), on clinical practice of mid-level practitioners. This article reports the effects of these interventions on clinical practice in management of common childhood illnesses. Two trainees from each of 36 health facilities participated in the IMID training. IMID was a three-week core course, two one-week boost courses, and distance learning over nine months. Eighteen of the 36 health facilities were then randomly assigned to arm A, and participated in OSS, while the other 18 health facilities assigned to arm B did not. Clinical faculty assessed trainee practice on clinical practice of six sets of tasks: patient history, physical examination, laboratory tests, diagnosis, treatment, and patient/caregiver education. The effects of IMID were measured by the post/pre adjusted relative risk (aRR) of appropriate practice in arm B. The incremental effects of OSS were measured by the adjusted ratio of relative risks (aRRR) in arm A compared to arm B. All hypotheses were tested at a 5% level of significance. Patient samples were comparable across arms at baseline and endline. The majority of children were aged under five years; 84% at baseline and 97% at endline. The effects of IMID on patient history (aRR = 1.12; 95% CI = 1.04-1.21) and physical examination (aRR = 1.40; 95% CI = 1.16-1.68) tasks were statistically significant. OSS was associated with incremental improvement in patient history (aRRR = 1.18; 95% CI = 1.06-1.31), and physical examination (aRRR = 1.27; 95% CI = 1.02-1.59) tasks. Improvements in laboratory testing, diagnosis, treatment, and patient/caregiver education were not statistically significant. IMID training was associated with improved patient history taking and physical examination, and OSS further improved these clinical practices. On-site training and continuous quality improvement activities support transfer of learning to practice among mid-level practitioners.

Effect of resveratrol on lipid profile: An updated systematic review and meta-analysis on randomized clinical trials.

PubMed

Haghighatdoost, Fahimeh; Hariri, Mitra

2018-03-01

Despite the notion that resveratrol can significantly reduce plasma lipids, the result of randomized clinical trials (RCTs) on resveratrol effect and the serum lipid profile are contradictory. Our objective was to conduct a systematic review and meta-analysis on randomized clinical trials (RCTs) and assess the effect of resveratrol on lipids. ISI web of science, Ovid, PubMed/Medline, SCOPUS, and Google Scholar data bases were searched up to Jun 2017. RCTs that assessed resveratrol effects on lipid profile among adult participants were chosen. Treatment effects were considered as weighted mean difference (WMD) and the corresponding standard error (SE) in concentrations of serum lipids. To estimate the overall summary effect, we used random-effects model. The protocol was registered with PROSPERO (No. CRD42017072365). This meta-analysis was performed on twenty-one trials. Our results indicated that resveratrol can't significantly change total cholesterol (TC) (WMD = -0.08 mmol/l, 95% CI: -0.23, 0.08; P = .349, I 2  = 87.8%), low-density lipoprotein (LDL-C) (WMD: -0.04 mmol/l, 95% CI: -0.21, 0.12; P = .620, I 2  = 93.4%), and high density lipoprotein (HDL-C) (WMD: -0.01 mmol/l, 95% CI: -0.04, 0.02; P = .269, I 2  = 88.6%). Its effect on triacylglycerol (TG) (WMD: 0.58 mmol/l, 95% CI: 0.34, 0.82; P < .0001, I 2  = 99.8%), was significant, but after removing one study the significance was eliminated. We also found that sex, age, BMI, resveratrol dosage, and intervention duration could not change the results. We conclude that resveratrol does not change lipid profile concentration. Confirmation of this conclusion will require more studies exclusively on dyslipidemic patients in which the intake of lipid lowering agents is among the exclusion criteria. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effects and safety of 99Tc-MDP in patients with refractory ankylosing spondylitis: a 2-stage (30-week follow-up) clinical trial.

PubMed

Xu, Yunyun; Zhong, Yi; Zhao, Minjing; Tu, Liudan; Fan, Meida; Zhang, Pingping; Wei, Qiujing; Cao, Shuangyan; Li, Qiuxia; Liao, Zetao; Lin, Zhiming; Pan, Yunfeng; Jin, Ou; Gu, Jieruo

2018-01-01

To evaluate the clinical efficacy and safety in patients with refractory ankylosing spondylitis (AS) initiating 99Tc-MDP therapy and explore the mechanisms. Refractory AS patients were enrolled in the clinical trial and received 99Tc-MDP treatments for 3 or 5 courses according to ASAS improvement. Efficacy and safety evaluations were conducted during the follow-up. 37 cytokines were quantified by Luminex at baseline and week 30. p-values<0.05 were considered statistically significant. 51 refractory AS patients were included, with 20 healthy people serving as the control group. The patients were in an active disease state (mean (SD) ASDAS 3.66 (0.83), BASDAI 4.53 (1.92)), 42(82.35%) patients had syndesmophytes. Their cytokines were significantly higher than that in the control group. After 3 courses of 99Tc-MDP treatment, 32 (62.75%) patients achieved ASAS20 improvement, 24 (47.06%) patients achieved a clinically significant improvement (ΔASDAS-CRP≥1.1). 27 patients entered the second stage to complete 5 courses of the treatment, all of whom achieved ASAS20 improvement, 18 (66.67%) patients achieved a clinically significant improvement. All clinical parameters including ASAS and ASDAS significantly improved as the treatment was continued. Cytokines also had significant down-regulation after the treatment, and the reductions had positive correlations with the improvements of disease activity. No serious adverse event was observed. This investigation confirmed the remarkable efficacy of 99Tc-MDP in a large number of refractory AS patients, and highlighted the mechanism by dramatic regulation on cytokines. 99Tc-MDP was safe in clinical application.

Validation of SURE, a four-item clinical checklist for detecting decisional conflict in patients.

PubMed

Ferron Parayre, Audrey; Labrecque, Michel; Rousseau, Michel; Turcotte, Stéphane; Légaré, France

2014-01-01

We sought to determine the psychometric properties of SURE, a 4-item checklist designed to screen for clinically significant decisional conflict in clinical practice. This study was a secondary analysis of a clustered randomized trial assessing the effect of DECISION+2, a 2-hour online tutorial followed by a 2-hour interactive workshop on shared decision making, on decisions to use antibiotics for acute respiratory infections. Patients completed SURE and also the Decisional Conflict Scale (DCS), as the gold standard, after consultation. We evaluated internal consistency of SURE using the Kuder-Richardson 20 coefficient (KR-20). We compared DCS and SURE scores using the Spearman correlation coefficient. We assessed sensitivity and specificity of SURE scores (cut-off score ≤3 out of 4) by identifying patients with and without clinically significant decisional conflict (DCS score >37.5 on a scale of 0-100). Of the 712 patients recruited during the trial, 654 completed both tools. SURE scores showed adequate internal consistency (KR-20 coefficient of 0.7). There was a significant correlation between DCS and SURE scores (Spearman's ρ = -0.45, P < 0.0001). The prevalence of clinically significant decisional conflict as estimated by the DCS was 5.2% (95% CI 3.7-7.3). Sensitivity and specificity of SURE ≤3 were 94.1% (95% CI 78.9-99.0) and 89.8% (95% CI 87.1-92.0), respectively. SURE shows adequate psychometric properties in a primary care population with a low prevalence of clinically significant decisional conflict. SURE has the potential to be a useful screening tool for practitioners, responding to the growing need for detecting clinically significant decisional conflict in patients.

The Medication Recommendation Tracking Form: a novel tool for tracking changes in prescribed medication, clinical decision making, and use in comparative effectiveness research.

PubMed

Reilly-Harrington, Noreen A; Sylvia, Louisa G; Leon, Andrew C; Shesler, Leah W; Ketter, Terence A; Bowden, Charles L; Calabrese, Joseph R; Friedman, Edward S; Ostacher, Michael J; Iosifescu, Dan V; Rabideau, Dustin J; Thase, Michael E; Nierenberg, Andrew A

2013-11-01

This paper describes the development and use of the Medication Recommendation Tracking Form (MRTF), a novel method for capturing physician prescribing behavior and clinical decision making. The Bipolar Trials Network developed and implemented the MRTF in a comparative effectiveness study for bipolar disorder (LiTMUS). The MRTF was used to assess the frequency, types, and reasons for medication adjustments. Changes in treatment were operationalized by the metric Necessary Clinical Adjustments (NCA), defined as medication adjustments to reduce symptoms, optimize treatment response and functioning, or to address intolerable side effects. Randomized treatment groups did not differ in rates of NCAs, however, responders had significantly fewer NCAs than non-responders. Patients who had more NCAs during their previous visit had significantly lower odds of responding at the current visit. For each one-unit increase in previous CGI-BP depression score and CGI-BP overall severity score, patients had an increased NCA rate of 13% and 15%, respectively at the present visit. Ten-unit increases in previous Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) scores resulted in an 18% and 14% increase in rates of NCAs, respectively. Patients with fewer NCAs had increased quality of life and decreased functional impairment. The MRTF standardizes the reporting and rationale for medication adjustments and provides an innovative metric for clinical effectiveness. As the first tool in psychiatry to track the types and reasons for medication changes, it has important implications for training new clinicians and examining clinical decision making. (ClinicalTrials.gov number NCT00667745). Copyright © 2013. Published by Elsevier Ltd.

[Short-term results of treatment with 131I in patients with multinodular goiter: effect of the associated degree of hyperthyroidism and other variables].

PubMed

Boj Carceller, D; Liévano Segundo, P; Navarro Beltrán, P; Sanz París, A; de Castro Hernández, P; Monreal Villanueva, M; Abós Olivares, D

2011-01-01

To assess the effectiveness of radioactive iodine (RAI) therapy and the incidence of hypothyroidism post RAI in patients with subclinical hyperthyroidism or clinical hyperthyroidism with Multinodular Goiter (MNG). A retrospective study of 69 consecutive patients treated with (131)I for MNG during the year 2008 observed for six months. All patients received a single fixed dose of 16 mCi (592 MBq) weighted by the gland size. They were categorized into two groups: subclinical hyperthyroidism or clinical hyperthyroidism. We compared the success rate and the incidence of hypothyroidism. The thyroid dysfunction was corrected in 82.09% of the patients. Success rate was 100% in the clinical hyperthyroidism group and 78.13% in the subclinical hyperthyroidism group (P=0.105). The overall incidence of hypothyroidism was 16.42%; 25.00% of patients with clinical hyperthyroidism and 14.55% with subclinical hyperthyroidism developed this secondary effect (P=0.400). No statistically significant differences were found in the success rate in the incidence of hypothyroidism when the results were analyzed according to the thyrotropin decrease in patients with subclinical hyperthyroidism. Seven patients had positive anti-thyroid peroxidase antibodies (anti-TPO) before therapy. The incidence of hypothyroidism was significantly higher in them (57.14% vs 11.67%; P=0.011). Cardiac arrhythmias were four times more frequent in patients with clinical hyperthyroidism. Previous treatment with thiamazol positively affected the outcome. A single fixed weighted dose of (131)I is highly effective and safe for the control of clinical and subclinical hyperthyroidism due to MNG. Patients with anti-TPO antibodies may have a high risk of developing post-iodine hypothyroidism. Copyright © 2010 Elsevier España, S.L. y SEMNIM. All rights reserved.

Targeting intensive versus conventional glycaemic control for type 1 diabetes mellitus: a systematic review with meta-analyses and trial sequential analyses of randomised clinical trials.

PubMed

Kähler, Pernille; Grevstad, Berit; Almdal, Thomas; Gluud, Christian; Wetterslev, Jørn; Lund, Søren Søgaard; Vaag, Allan; Hemmingsen, Bianca

2014-08-19

To assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus. A systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded and LILACS to January 2013. Randomised clinical trials that prespecified different targets of glycaemic control in participants at any age with type 1 diabetes mellitus were included. Two authors independently assessed studies for inclusion and extracted data. 18 randomised clinical trials included 2254 participants with type 1 diabetes mellitus. All trials had high risk of bias. There was no statistically significant effect of targeting intensive glycaemic control on all-cause mortality (risk ratio 1.16, 95% CI 0.65 to 2.08) or cardiovascular mortality (0.49, 0.19 to 1.24). Targeting intensive glycaemic control reduced the relative risks for the composite macrovascular outcome (0.63, 0.41 to 0.96; p=0.03), and nephropathy (0.37, 0.27 to 0.50; p<0.00001. The effect estimates of retinopathy, ketoacidosis and retinal photocoagulation were not consistently statistically significant between random and fixed effects models. The risk of severe hypoglycaemia was significantly increased with intensive glycaemic targets (1.40, 1.01 to 1.94). Trial sequential analyses showed that the amount of data needed to demonstrate a relative risk reduction of 10% were, in general, inadequate. There was no significant effect towards improved all-cause mortality when targeting intensive glycaemic control compared with conventional glycaemic control. However, there may be beneficial effects of targeting intensive glycaemic control on the composite macrovascular outcome and on nephropathy, and detrimental effects on severe hypoglycaemia. Notably, the data for retinopathy and ketoacidosis were inconsistent. There was a severe lack of reporting on patient relevant outcomes, and all trials had poor bias control. 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.

Effect of intrauterine injection of human chorionic gonadotropin before embryo transfer on clinical pregnancy rates from in vitro fertilisation cycles: a prospective study.

PubMed

Santibañez, Alvaro; García, Jorge; Pashkova, Olga; Colín, Omar; Castellanos, Guillermo; Sánchez, Ana P; De la Jara, Julio F

2014-01-29

The implantation process after embryo transfer depends on the embryo quality and endometrial receptivity. It is estimated that fifty to seventy-five per cent of pregnancies are lost due to a failure of implantation. There is evidence that there is an early secretion of human chorionic gonadotrophin before embryo implantation, and this secretion has been linked to an important function in angiogenesis and the inflammatory response that promotes the implantation process. Our objective was to determine the effects of intrauterine injection of human chorionic gonadotropin (hCG) before the embryo transfer in an in vitro fertilisation cycle. A prospective randomised study was conducted in Reproductive Medicine Centre PROCREA in Mexico City. Infertile patients who had a medical indication for in vitro fertilisation were studied. Two groups were included (n 210); the intervention group received an intrauterine injection of 500 IU of hCG before the embryo transfer (n 101). The control group (n 109) did not receive hCG. Comparisons were performed using a chi-square test. The clinical pregnancy rate (CPR) was our principal outcome. The implantation rate was a secondary outcome. The implantation rate was significantly higher in the hCG group compared to the control group (52.4% vs 35.7%, p 0.014). The clinical pregnancy rate was also significantly higher (50.4 vs 33.0%, p 0.010). No adverse effects were observed. The intrauterine injection of hCG before embryo transfer showed a significant increase in the clinical pregnancy rate. More clinical trials are needed to reproduce these results on this promising intervention. The live birth rate must be included in subsequent studies.

Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: analysis of clinical trials of human rotavirus vaccine.

PubMed

Cheuvart, Brigitte; Neuzil, Kathleen M; Steele, A Duncan; Cunliffe, Nigel; Madhi, Shabir A; Karkada, Naveen; Han, Htay Htay; Vinals, Carla

2014-01-01

Clinical trials of the human rotavirus vaccine Rotarix™ (RV1) have demonstrated significant reductions in severe rotavirus gastroenteritis (RVGE) in children worldwide. However, no correlate of vaccine efficacy (VE) has yet been established. This paper presents 2 analyses which aimed to investigate whether serum anti-RV IgA measured by ELISA 1 or 2 mo post-vaccination can serve as a correlate of efficacy against RVGE: (1) In a large Phase III efficacy trial (Rota-037), the Prentice criteria for surrogate endpoints was applied to anti-RV IgA seropositivity 1 mo post-vaccination. These criteria determine whether a significant vaccine group effect can be predicted from the surrogate, namely seropositivity (anti-RV IgA concentration>20 U/mL); (2) Among other GSK-sponsored RV1 VE studies, 8 studies which assessed immunogenicity at 1 or 2 mo post-vaccination in all or a sub-cohort of enrolled subjects and had at least 10 RVGE episodes were included in a meta-analysis to measure the regression between clinical VE and VE predicted from immunogenicity (VE1). In Rota-037, anti-RV IgA seropositivity post-vaccination was associated with a lower incidence of any or severe RVGE, however, the proportion of vaccine group effect explained by seropositivity was only 43.6% and 32.7% respectively. This low proportion was due to the vaccine group effect observed in seronegative subjects. In the meta-analysis, the slope of the regression between clinical VE and VE1 was statistically significant. These two independent analyses support the hypothesis that post-vaccination anti-RV IgA seropositivity (antibody concentration ≥20 U/mL) may serve as a useful correlate of efficacy in clinical trials of RV1 vaccines.

Educational effects using a robot patient simulation system for development of clinical attitude.

PubMed

Abe, S; Noguchi, N; Matsuka, Y; Shinohara, C; Kimura, T; Oka, K; Okura, K; Rodis, O M M; Kawano, F

2017-11-01

The aim of this study was to assess the effectiveness of improving the attitude of dental students towards the use of a full-body patient simulation system (SIMROID) compared to the traditional mannequin (CLINSIM) for dental clinical education. The participants were 10 male undergraduate dental students who had finished clinical training in the university hospital 1 year before this study started. They performed a crown preparation on an upper pre-molar tooth using SIMROID and CLINSIM as the practical clinical trials. The elapsed time for preparation was recorded. The taper of the abutment teeth was measured using a 3-dimensional shape-measuring device after this trial. In addition, a self-reported questionnaire was collected that included physical pain, treatment safety and maintaining a clean area for each simulator. Qualitative data analysis of a free format report about SIMROID was performed using text mining analysis. This trial was performed twice at 1-month intervals. The students considered physical pain, treatment safety and a clean area for SIMROID significantly better than that for CLINSIM (P < .01). The elapsed time of preparation in the second practical clinical trial was significantly lower than in the first for SIMROID and CLINSIM (P < .01). However, there were no significant differences between the abutment tapers for both systems. For the text mining analysis, most of the students wrote that SIMROID was similar to real patients. The use of SIMROID was proven to be effective in improving the attitude of students towards patients, thereby giving importance to considerations for actual patients during dental treatment. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A national cross-sectional study on effects of fluoride-safe water supply on the prevalence of fluorosis in China.

PubMed

Wang, Cheng; Gao, Yanhui; Wang, Wei; Zhao, Lijun; Zhang, Wei; Han, Hepeng; Shi, Yuxia; Yu, Guangqian; Sun, Dianjun

2012-01-01

To assess the effects of provided fluoride-safe drinking-water for the prevention and control of endemic fluorosis in China. A national cross-sectional study in China. In 1985, randomly selected villages in 27 provinces (or cities and municipalities) in 5 geographic areas all over China. Involved 81 786 children aged from 8 to 12 and 594 698 adults aged over 16. The prevalence of dental fluorosis and clinical skeletal fluorosis, the fluoride concentrations in the drinking-water in study villages and in the urine of subjects. The study showed that in the villages where the drinking-water fluoride concentrations were higher than the government standard of 1.2 mg/l, but no fluoride-safe drinking-water supply scheme was provided (FNB areas), the prevalence rate and index of dental fluorosis in children, and prevalence rate of clinical skeletal fluorosis in adults were all significantly higher than those in the historical endemic fluorosis villages after the fluoride-safe drinking-water were provided (FSB areas). Additionally, the prevalence rate of dental fluorosis as well as clinical skeletal fluorosis, and the concentration of fluoride in urine were found increased with the increase of fluoride concentration in drinking-water, with significant positive correlations in the FNB areas. While, the prevalence rate of dental fluorosis and clinical skeletal fluorosis in different age groups and their degrees of prevalence were significantly lower in the FSB areas than those in the FNB areas. The provision of fluoride-safe drinking-water supply schemes had significant effects on the prevention and control of dental fluorosis and skeletal fluorosis. The study also indicated that the dental and skeletal fluorosis is still prevailing in the high-fluoride drinking-water areas in China.

Efficacy of Naltrexone for the Treatment of Alcohol Dependence in Latino Populations.

PubMed

López, Cristina M; Barr, Simone C; Reid-Quiñones, Kathryn; de Arellano, Michael A

2017-05-01

Naltrexone has been identified as a promising psychopharmacological treatment for alcohol dependence. Previous studies have suggested that its efficacy may vary based on ethnic background. The current study examined the efficacy of naltrexone in the treatment of alcohol dependence in Latino adults, a previously unexplored population. This was a secondary analysis of the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) Study. The overall COMBINE sample consisted of 1,383 adult participants who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for alcohol dependence, including 155 Latinos, who are the focus of this report. Consistent with the main trial, primary drinking outcomes, including percentage of days abstinent (PDA) and time to first heavy drinking day (TTHD), were examined. In addition, we examined the effects of naltrexone on a clinically relevant secondary outcome measure, global clinical outcome of alcohol consumption and alcohol-related problems. As seen with the subsample of African Americans from the COMBINE Study, results of the present analysis indicated that there were no significant effects of naltrexone on PDA and TTHD despite these significant effects in the original study. However, contrary to findings in the African American subsample, for Latino participants naltrexone was a significant predictor of a good global clinical outcome (i.e., abstinence or moderate drinking without problems). Naltrexone was not significantly associated with improvements in the primary drinking outcomes of PDA or TTHD at the end of treatment or at follow-up. However, Latinos appeared to benefit from naltrexone as demonstrated by improved ratings of global clinical outcome. These results indicate mixed findings for the efficacy of naltrexone among Latinos in the COMBINE Study.

The training and detraining effect of high-intensity interval training on post-exercise hypotension in young overweight/obese women.

PubMed

Bonsu, Biggie; Terblanche, Elmarie

2016-01-01

Studies evaluating the response in blood pressure (BP) following high-intensity interval training (HIIT) are scant even though there has been extensive work done on the BP response following acute and chronic low- to moderate-intensity aerobic and resistance exercise in both hypertensive and normotensive individuals. The present study sought to investigate the training and detraining effects of short-term HIIT on the post-exercise hypotension (PEH) response in overweight/obese young women. Twenty young untrained women volunteered for the study. Participants performed six HIIT sessions on a treadmill within 2 weeks (week 1: 10 × 1 min and week 2: 15 × 1 min intervals at 90-95% HRmax, separated by 1 min active recovery at 70% HRmax each session) and detrained for 2 weeks. Post-exercise BP was measured for 1 h following the first and last HIIT sessions. Participants were normotensive (SBP: 119.2 ± 5.60 mmHg; DBP: 78.8 ± 4.12 mmHg) and had a BMI greater than 25 kg m(-2). The magnitude of the systolic hypotensive response was slightly greater after the six sessions HIIT compared to pre-training (5.04 and 4.28 mmHg, respectively), and both would be considered clinically significant (>3 mmHg decrease). After 2 weeks, detraining the PEH response was not clinically significant (1.08 mmHg decrease). The magnitude of the DBP response was only clinically significant following post- and detraining (4.26 and 3.87 mmHg, respectively). The findings suggest that six HIIT sessions is sufficient to affect clinically significant PEH responses in young, overweight/obese women; however, the training effects are lost within 2 weeks of detraining.

Depression and its impact on health-related quality of life among Chinese inpatients with lung cancer.

PubMed

Gu, Wen; Xu, Yan-Min; Zhu, Jun-Hong; Zhong, Bao-Liang

2017-12-01

Depression is of great concern for patients with cancer. A detailed epidemiological profile of depression in Chinese patients with lung cancer and whether depression impacts patients' health-related quality of life (HRQOL) remain unknown. This study examined the prevalence and socio-demographic and clinical correlates of depression and its effect on HRQOL in Chinese inpatients with lung cancer of two large general hospitals. A total of 148 inpatients were consecutively recruited, and administered with a standardized questionnaire to collect socio-demographic and clinical data. Depression and HRQOL were assessed with the Hospital Anxiety and Depression Scale and World Health Organization QOL Scale Brief Version, respectively. As high as 43.2% Chinese inpatients with lung cancer had clinically significant depressive symptoms. Multiple logistic regression found that depression was significantly associated with moderate-to-severe pain (OR: 4.43), metastatic cancer (OR: 3.63), a short duration after cancer diagnosis (OR: 1.04), poor performance status (OR: 3.41), and small-cell cancer (OR: 4.52). Depressed patients had significantly poorer HRQOL than not depressed patients in terms of all four domains of HRQOL. After controlling for the potential confounding effects of socio-demographic and clinical factors with analysis of covariance, these group-differences in physical (F = 29.074, P < 0.001), psychological (F = 76.869, P < 0.001), social (F = 21.465, P < 0.001), and environmental (F = 27.685, P < 0.001) HRQOL remained statistically significant. Depression is prevalent in inpatients with lung cancer and independently associated with poor HRQOL. To address this serious issue, effective pain management, psycho-oncology services and, when necessary, psychiatric assessment and treatment, should be routinely provided in oncology departments of Chinese general hospitals.

Effect of Feeding an Iodine-Restricted Diet in Cats with Spontaneous Hyperthyroidism.

PubMed

Hui, T Y; Bruyette, D S; Moore, G E; Scott-Moncrieff, J C

2015-01-01

Exclusive feeding of an iodine-restricted diet has been proposed as a method for controlling clinical manifestations of hyperthyroidism in hyperthyroid cats. To determine the effect of feeding an iodine-restricted diet on TT4 concentrations and clinical signs in cats with spontaneous hyperthyroidism. Forty-nine client-owned cats with spontaneous hyperthyroidism. Retrospective case series. Hyperthyroid cats were exclusively fed a commercially available iodine-restricted diet. Clinical response was assessed by change in weight and heart rate and serum TT4, blood urea nitrogen (BUN), and creatinine concentrations at various times during dietary management (21-60 days, 60-180 days). Serum TT4 normalized in 20/48 cats (42%) and 39/47 cats (83%) at 21-60 days and 61-180 days, respectively. Cats in which the TT4 concentrations were still above reference range at 21-60 days had a significantly higher starting TT4 than those that normalized their TT4 levels during the same time period (P = .038). Body weight did not significantly increase (P = .34) nor heart rate decrease (P = .64) during the study. There was a significant decrease in serum creatinine (P = .028). Cats in the low reference range for serum TT4 concentrations did not have a significant increase in body weight (P = .41) nor creatinine (P = .54) when compared to those with high reference range. Restricted-iodine diets were effective at maintaining serum TT4 concentrations within reference ranges for a majority of cats with spontaneous hyperthyroidism over 1 year, although not all clinical signs of hyperthyroidism improved. Copyright © 2015 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Additive Effect of Plasma Rich in Growth Factors With Guided Tissue Regeneration in Treatment of Intrabony Defects in Patients With Chronic Periodontitis: A Split-Mouth Randomized Controlled Clinical Trial.

PubMed

Ravi, Sheethalan; Malaiappan, Sankari; Varghese, Sheeja; Jayakumar, Nadathur D; Prakasam, Gopinath

2017-09-01

Periodontal regeneration can be defined as complete restoration of lost periodontal tissues to their original architecture and function. A variety of treatment modalities have been proposed to achieve it. Plasma rich in growth factors (PRGF) is a concentrated suspension of growth factors that promotes restoration of lost periodontal tissues. The objective of the present study is to assess the effect of PRGF associated with guided tissue regeneration (GTR) versus GTR only in the treatment of intrabony defects (IBDs) in patients with chronic periodontitis (CP). Patients with CP (n = 14) with 42 contralateral 2- and 3-walled defects were randomly assigned to test (PRGF+GTR) and control (GTR alone) treatment groups. Clinical and radiographic assessments performed at baseline and after 6 months were: 1) gingival index (GI), 2) probing depth (PD), 3) clinical attachment level (CAL), 4) radiologic defect depth, and 5) bone fill. Comparison of parameters measured at baseline and after 6 months showed mean PD reduction of 3.37 ± 1.62 mm in the control group (P <0.001) and 4.13 ± 1.59 mm in the test group (P <0.001). There was a significant difference in mean change in CAL (P <0.001) in the control group (5.42 ± 1.99) and the test group (5.99 ± 1.77). Mean change in GI was 1.89 ± 0.32 and 1.68 ± 0.58 in the control group and test group, respectively, and the difference was statistically significant (P <0.001). When compared between groups, clinical parameters did not show any statistically significant variations. Mean radiographic bone fill was 1.06 ± 0.81 and 1.0 ± 0.97 in the control group and test group, respectively. However, the difference was not statistically significant. PRGF with GTR, as well as GTR alone, was effective in improving clinical and radiographic parameters of patients with CP at the 6-month follow-up. There was no additive effect of PRGF when used along with GTR in the treatment of IBDs in patients with CP in terms of both clinical and radiologic outcomes.

Massage as adjuvant therapy in the management of post-cesarean pain and anxiety: A randomized clinical trial.

PubMed

Saatsaz, Sussan; Rezaei, Rozita; Alipour, Abbas; Beheshti, Zahra

2016-08-01

The present study was conducted to determine the effect of massage on post-cesarean pain and anxiety. The present single-blind clinical trial was conducted on 156 primiparous women undergone elective cesarean section. The participants were randomly divided into three groups, including a hand and foot massage group, a foot massage group and a control group (n = 52 per group). The patients' intensity of pain, vital signs and anxiety level were measured before, immediately after and 90 min after the massage. A significant reduction was observed in the intensity of pain immediately and 90 min after massage (P < 0.001). Moreover, changes in some of the physiological parameters, including blood pressure and respiration rate, were significant after massage (P < 0.001); however, this change was not significant for pulse rate. A significant reduction was also observed in the level of anxiety (P < 0.001) and a significant increase in the frequency of breastfeeding (P < 0.001) after massage. As an effective nursing intervention presenting no side-effects, hand and foot massage can be helpful in the management of postoperative pain and stress. Copyright © 2016 Elsevier Ltd. All rights reserved.

The effect of pre-service training on post-graduation skill and knowledge retention among mid-level healthcare providers in Mozambique.

PubMed

Feldacker, Caryl; Chicumbe, Sergio; Dgedge, Martinho; Cesar, Freide; Augusto, Gerito; Robertson, Molly; Mbofana, Francisco; O'Malley, Gabrielle

2015-04-16

Mozambique suffers from critical shortages of healthcare workers including non-physician clinicians, Tecnicos de Medicina Geral (TMGs), who are often senior clinicians in rural health centres. The Mozambique Ministry of Health and the International Training and Education Center for Health, University of Washington, Seattle, revised the national curriculum to improve TMG clinical knowledge and skills. To evaluate the effort, data was collected at graduation and 10 months later from pre-revision (initial) and revised curriculum TMGs to determine the following: (1) Did cohorts trained in the revised curriculum score higher on measurements of clinical knowledge, physical exam procedures, and solving clinical case scenarios than those trained in the initial curriculum; (2) Did TMGs in both curricula retain their knowledge over time (from baseline to follow-up); and (3) Did skills and knowledge retention differ over time by curricula? Post-graduation and over time results are presented. t-tests examine differences in scores between curriculum groups. Univariate and multivariate linear regression models assess curriculum-related, demographic, and workplace factors associated with scores on each of three evaluation methods at the p < 0.05 level. Paired t-tests examine within-group changes over time. ANOVA models explore differences between Health Training Institutes (HTIs). Generalized estimating equations determine whether change in scores over time differed by curricula. Mean scores of initial curriculum TMGs at follow-up were 52.7%, 62.6%, and 40.0% on the clinical cases, knowledge test, and physical exam, respectively. Averages were significantly higher among the revised group for clinical cases (60.2%; p < 0.001) and physical exam (47.6%; p < 0.001). HTI was influential on clinical case and physical exam scores. Between graduation and follow-up, clinical case and physical exam scores decreased significantly for initial curriculum students; clinical case scores increased significantly among revised curriculum TMGs. Although curriculum revision had limited effect, marginal improvements in the revised group show promise that these TMGs may have increased ability to synthesize clinical information. Weaknesses in curriculum and practicum implementation likely compromised the effect of curriculum revision. An improvement strategy that includes strengthened TMG training, greater attention to pre-service clinical practice, and post-graduation mentoring may be more advantageous than curriculum revision, alone, to improve care provided by TMGs.

A Heart Failure Management Program Using Shared Medical Appointments.

PubMed

Carroll, Allison J; Howrey, Hillary L; Payvar, Susan; Deshida-Such, Kristen; Kansal, Mayank; Brar, Charanjit K

2017-04-01

Disease management programs for heart failure (HF) effectively reduce HF-related hospitalization rates and mortality. Shared medical appointments (SMAs) offer a cost-effective delivery method for HF disease management programs. However, few studies have evaluated this cost-effective delivery method of HF disease management among Veterans with acute HF. We hypothesized that Veterans who attended a multidisciplinary HF-SMA clinic promoting HF self-management, compared those who only received individual treatment through the HF specialty clinic, would have better 12-month hospitalization outcomes. We completed a retrospective review of the VA electronic health record for HF-SMA clinic appointments (1/1/2012 to 12/31/2013). The multidisciplinary HF-SMA program comprised 4 weekly sessions covering topics including HF disease, HF medications, diet adherence, physical activity, psychological well-being, and stress management. Patients who attended the HF-SMA clinic ( n =54) were compared to patients who were scheduled for an HF-SMA appointment but never attended and were followed only in the HF clinic ( n =37). Outcomes were 12-month HF-related and all-cause hospitalization rates, days in the hospital, and time to first hospitalization. Of 141 patients scheduled for an HF-SMA clinic appointment, 54 met criteria for the HF-SMA clinic group and 37 were included in the HF clinic group. The groups did not significantly differ on any sociodemographic variables. Furthermore, no significant differences were observed between the HF-SMA group and the HF clinic group on demographics or hospitalization outcomes, p >.05 for all comparisons. Our results did not support our hypothesis that offering multidisciplinary, HF-SMAs promoting HF self-management skills, above and beyond the individual disease management care provided in an HF specialty clinic, would improve hospitalization outcomes among Veterans with acute HF. Limitations of the present study and recommendations for HF self-management programs for Veterans are discussed.

The effect of vitamins C and e supplementation on muscle damage, performance, and body composition in athlete women: a clinical trial.

PubMed

Taghiyar, Maryam; Ghiasvand, Reza; Askari, Gholamreza; Feizi, Awat; Hariri, Mitra; Mashhadi, Nafiseh Shokri; Darvishi, Leila

2013-04-01

Due to the special training conditions and lifestyle athletes require an antioxidant system that is more efficient than others. To keep this system optimal, many of them use antioxidant supplements. This study aimed to investigate the effects of vitamins C and E supplementation on muscle damage, performance, and body composition in athlete women. The study was a 4-week randomized, double-blind clinical trial conducted on 64 trained female athletes recruited in Isfahan sports club. They were randomly assigned to one of the following four groups; A: vitamin C (250 mg/day), B: vitamin E (400 IU), C: vitamin C + vitamin E and control (placebo). Harvard Step Test was used to measure maximal oxygen consumption for performance, body composition, and damage marker (myoglobin) were measured before and after the intervention. Comparing the result of the test in performance of sport, there was no significant difference between groups in VO2 max. Also, vitamin supplements had no significant effect on subcutaneous fat between the groups, however, in the intergroup comparison, were significantly increased in group control (P = 0.03). But, there were no significant differences, change in myoglobin between the groups. There was a significant increase in group A (P = 0.04). Vitamins C and E supplementation had no significant effect on any of the studied parameters.

Effect of improving the realism of simulated clinical judgement tasks on nurses' overconfidence and underconfidence: evidence from a comparative confidence calibration analysis.

PubMed

Yang, Huiqin; Thompson, Carl; Bland, Martin

2012-12-01

Apparent overconfidence and underconfidence in clinicians making clinical judgements could be a feature of evaluative research designs that fail to accurately represent clinical environments. To test the effect of improved realism of clinical judgement tasks on confidence calibration performance of nurses and student nurses. A comparative confidence calibration analysis. The study was conducted in a large university of Northern England. Ninety-seven participants rated their confidence - using a scale that ranged from 0 (no confidence) to 100 (totally confident) on dichotomous clinical judgements of critical event risk. The judgements were in response to 25 paper-based and 25 higher fidelity scenarios using a computerised patient simulator and clinical equipment. Scenarios, and judgement criteria of 'correctness', were generated from real patient cases. Using a series of calibration measures (calibration, resolution and over/underconfidence), participants' confidence was calibrated against the proportion of correct judgements. The calibration measures generated by the paper-based and high fidelity clinical simulation conditions were compared. Participants made significantly less accurate clinical judgements of risk in the high fidelity clinical simulations compared to the paper simulations (P=0.0002). They were significantly less confident in high fidelity clinical simulations than paper simulations (P=0.03). However, there was no significant difference of over/underconfidence for participants between the two simulated settings (P=0.06). Participants were no better calibrated in the high fidelity clinical simulations than paper simulations, P=0.85. Likewise, participants had no better ability of discriminating correct judgements from incorrect judgements as measured by the resolution statistic in high fidelity clinical simulations than paper simulations, P=0.76. Improving the realism of simulated judgement tasks led to reduced confidence and judgement accuracy in participants but did not alter confidence calibration. These findings suggest that judgemental miscalibration of confidence in nurses may be a systematic cognitive bias and that simply making scenarios more realistic may not be a sufficient condition for correction. Copyright © 2012 Elsevier Ltd. All rights reserved.

Impact of environmental adaptation on tear film assessments.

PubMed

Fagehi, R

2018-03-01

The purpose of this study was to investigate the effect of ocular environmental adaptation on clinical tear film assessment. Thirty subjects (male, mean age 23±2.5) participated in this study. A number of clinical tear film tests were applied, including: fluorescein tear break-up time (FTBUT), Schirmer test and tear prism height test (TPH). The tear physiology of each subject was evaluated twice, once immediately when they arrived from the external environment, and then after 30minutes adaptation in the exam room environment. The mean values were: Schirmer test A (22.1±2.99), Schirmer test B (24.2±2.63), FTBUT A (8.00±1.94), FTBUT B (9.13±2.04), TPH A (0.179±0.026) and TPH B* (0.187±0.023). Statistical testing using Wilcoxon-signed rank test showed a significant difference between the Schirmer test results measured at the different times (P=0.008). Also, the FTBUT and tear prism height test results showed significant differences between the two evaluation times, (P=0.001, 0.011, respectively) (A: tear assessed when the subject comes from the outside environment, B: tear film assessed after 30min adaptation in the clinical environment). This study showed a significant difference between the tear film test results evaluated when the subjects were assessed immediately from the outside environment and after an adaptation time in the clinic environment. Practitioners must consider the effect of differences between external and clinical environment adaptation on clinical tear film physiology. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Antianxiety effect of cannabis: involvement of central benzodiazepine receptors.

PubMed

Sethi, B B; Trivedi, J K; Kumar, P; Gulati, A; Agarwal, A K; Sethi, N

1986-01-01

The present work, involving clinical, behavioral, and biochemical studies, was undertaken to elucidate the probable mechanism of the observed antianxiety effects of cannabis. The population for the clinical study consisted of 50 male chronic cannabis users who were otherwise healthy and 50 matched controls. When evaluated on Taylor's Manifest Anxiety Scale (TMA), these subjects had low anxiety scores as compared with the controls. To explore the possible interaction of cannabis with the benzodiazepine receptors, behavioral and biochemical studies in mice were devised, involving acute and chronic cannabis administration. Behavioral study revealed that mice under chronic cannabis treatment scored significantly higher on foot shock-induced aggression, but this was significantly blocked by benzodiazepine receptor antagonist. Furthermore, chronic cannabis treatment significantly (p less than 0.001) increased the frequency of licking response periodically punished by shocks. This confirms the antianxiety effect of cannabis, which also appears to be mediated through a benzodiazepine receptor, as it was reduced significantly (p less than 0.001) by a benzodiazepine receptor blocker. Specific 3H-diazepam binding was carried out in frontal cortex to assess both the population and affinity of benzodiazepine receptors. Our results indicate that acute cannabis treatment has no significant effect, whereas chronic cannabis treatment significantly increased 3H-diazepam binding as compared with controls. Scatchard analysis further reveals that increased affinity is responsible for increased binding to these receptors. It is therefore our contention that the antianxiety effect of cannabis is mediated through central benzodiazepine receptors.

Effect of length and location of edentulous area on the accuracy of prosthetic treatment plan incorporation into cone-beam computed tomography scans.

PubMed

Jamjoom, Faris Z; Kim, Do-Gyoon; Lee, Damian J; McGlumphy, Edwin A; Yilmaz, Burak

2018-02-05

Effects of length and location of the edentulous area on the accuracy of prosthetic treatment plan incorporation into cone-beam computed tomography (CBCT) scans has not been investigated. To evaluate the effect of length and location of the edentulous area on the accuracy of prosthetic treatment plan incorporation into CBCT scans using different methods. Direct digital scans of a completely dentate master model with removable radiopaque teeth were made using an intraoral scanner, and digital scans of stone duplicates of the master model were made using a laboratory scanner. Specific teeth were removed to simulate different clinical situations and their CBCT scans were made. Surface scans were registered onto the CBCT scans. Radiographic templates for each clinical situation were also fabricated and used during CBCT scans of the master models. Using metrology software, three-dimensional (3D) deviation was measured on standard tesselation language (STL) files created from the CBCT scans against an STL file of the master model created from a CBCT scan. Statistical analysis was done using the MIXED procedure in a statistical software and Tukey HSD test (α =.05). The interaction between location and method was significant (P = .009). Location had no significant effect on registration methods (P > .05), but on the radiographic templates (P = .011). Length of the edentulous area did not have any significant effect (P > .05). Accuracy of digital image registration methods was similar and higher than that of radiographic templates in all clinical situations. Tooth-bound radiographic templates were significantly more accurate than the free-end templates. The results of this study suggest using image registration instead of radiographic templates when planning dental implants, particularly in free-end situations. © 2018 Wiley Periodicals, Inc.

Vasopressin, cortisol, and catecholamine concentrations in dogs with dilated cardiomyopathy.

PubMed

Tidholm, Anna; Häggström, Jens; Hansson, Kerstin

2005-10-01

To evaluate plasma concentrations and urinary excretion of vasopressin and cortisol and urinary excretion of catecholamines in dogs with dilated cardiomyopathy (DCM). 15 dogs with clinical signs of DCM, 15 dogs with preclinical DCM, and 15 control dogs. Physical examinations, thoracic radiography, ECG, and echocardiography were performed on all dogs. Blood and urine samples were collected. Plasma concentration of vasopressin and the urine cortisol-to-urine creatinine ratio were significantly increased in dogs with clinical signs of DCM and dogs with preclinical DCM, compared with control dogs. Plasma vasopressin concentration was significantly higher in dogs with clinical signs of DCM, compared with dogs with preclinical DCM. Urine vasopressin-to-urine creatinine ratio was significantly increased in dogs with clinical signs of DCM, compared with dogs with preclinical DCM and control dogs. Urine epinephrine-to-urine creatinine ratio and urine norepinephrine-to-urine creatinine ratio were significantly increased in dogs with clinical signs of DCM, compared with control dogs. Plasma concentration of cortisol and urine dopamine-to-urine creatinine ratio did not differ significantly among groups. According to this study, the neuroendocrine pattern is changed in dogs with preclinical DCM. These changes are even more pronounced in dogs with clinical signs of DCM. Analysis of concentrations of vasopressin, cortisol, and catecholamines may aid in identification of the clinical stages of DCM. These findings may also provide a basis for additional studies of the possible beneficial effects of vasopressin antagonists and beta-adrenergic receptor antagonists in the treatment of dogs with congestive heart failure and DCM.

The relationship between session frequency and psychotherapy outcome in a naturalistic setting.

PubMed

Erekson, David M; Lambert, Michael J; Eggett, Dennis L

2015-12-01

The dose-response relationship in psychotherapy has been examined extensively, but few studies have included session frequency as a component of psychotherapy "dose." Studies that have examined session frequency have indicated that it may affect both the speed and the amount of recovery. No studies were found examining the clinical significance of this construct in a naturalistic setting, which is the aim of the current study. Using an archival database of session-by-session Outcome Questionnaire 45 (OQ-45) measures over 17 years, change trajectories of 21,488 university counseling center clients (54.9% female, 85.0% White, mean age = 22.5) were examined using multilevel modeling, including session frequency at the occasion level. Of these clients, subgroups that attended therapy approximately weekly or fortnightly were compared to each other for differences in speed of recovery (using multilevel Cox regression) and clinically significant change (using multilevel logistic regression). Results indicated that more frequent therapy was associated with steeper recovery curves (Cohen's f2 = 0.07; an effect size between small and medium). When comparing weekly and fortnightly groups, clinically significant gains were achieved faster for those attending weekly sessions; however, few significant differences were found between groups in total amount of change in therapy. Findings replicated previous session frequency literature and supported a clinically significant effect, where higher session frequency resulted in faster recovery. Session frequency appears to be an impactful component in delivering more efficient psychotherapy, and it is important to consider in individual treatment planning, institutional policy, and future research. (c) 2015 APA, all rights reserved).

Nonsurgical treatment of moderate and advanced periimplantitis lesions: a controlled clinical study.

PubMed

Schwarz, Frank; Bieling, Katrin; Bonsmann, Martin; Latz, Thilo; Becker, Jürgen

2006-12-01

The aim of this controlled, parallel design clinical study was to evaluate the effectiveness of an Er:YAG (erbium-doped:yttrium, aluminum, and garnet) laser for nonsurgical treatment of periimplantitis lesions. Twenty patients, each of whom displayed at least one implant with (a) moderate and (b) advanced periimplantitis (n=40 implants; IMZ, ITI, Spline Twist, ZL-Duraplant, Camlog), were randomly instrumented nonsurgically using either (1) an Er:YAG laser (100 mJ/pulse, 10 Hz) device (LAS) or (2) mechanical debridement using plastic curettes and antiseptic therapy with chlorhexidine digluconate (0.2%) (C). The following clinical parameters were measured at baseline, 3, 6, and 12 months after treatment: plaque index, bleeding on probing (BOP), probing depth, gingival recession, and clinical attachment level (CAL). Mean BOP improved significantly in both groups at 3, 6, and 12 months (a- lesions: P<0.001 and b- lesions: P<0.01, respectively). After 3 and 6 months, the mean reduction of BOP was significantly higher in the LAS group when compared to the C group (a- and b- lesions: P<0.01 and P<0.05, respectively). At 3 and 6 months, both groups revealed significant CAL gains at a- and b- lesions (P<0.01, respectively). In both groups, however, the mean CAL at a- and b- lesions was not significantly different from the respective baseline values at 12 months (P>0.05, respectively). Although treatment of periimplantitis lesions with LAS resulted in a significantly higher BOP reduction than C, its effectiveness seemed to be limited to a period of 6 months, particularly at b- lesions.

The effects of photodynamic laser therapy in the treatment of marginal chronic periodontitis

NASA Astrophysics Data System (ADS)

Chifor, Radu; Badea, Iulia; Avram, Ramona; Chifor, Ioana; Badea, Mîndra Eugenia

2016-03-01

The aim of this study was to assess the effects of the antimicrobial photodynamic laser therapy performed during the treatment of deep periodontal disease by using 40 MHz high frequency ultrasonography. The periodontal data recorded during the clinical examination before each treatment session were compared with volumetric changes of the gingiva measured on periodontal ultrasound images. The results show a significant decrease of gingival tissue inflammation proved both by a significant decrease of bleeding on probing as well as by a decrease of the gingival tissues volume on sites where the laser therapy was performed. Periodontal tissues that benefit of laser therapy besides classical non-surgical treatment showed a significant clinical improvement of periodontal status. Based on these findings we were able to conclude that the antimicrobial photodynamic laser therapy applied on marginal periodontium has important anti-inflamatory effect. The periodontal ultrasonography is a method which can provide useful data for assessing the volume changes of gingival tissues, allowing a precise monitoring of marginal periodontitis.

The Effect of Topical Rosa damascena (Rose) Oil on Pregnancy-Related Low Back Pain: A Randomized Controlled Clinical Trial.

PubMed

Shirazi, Mahbobeh; Mohebitabar, Safieh; Bioos, Sodabeh; Yekaninejad, Mir Saeed; Rahimi, Roja; Shahpiri, Zahra; Malekshahi, Farhad; Nejatbakhsh, Fatemeh

2017-01-01

The study aimed to assess the efficacy of topical rose oil in women with pregnancy-related low back pain. A randomized controlled clinical trial was conducted on 120 women with pregnancy-related low back pain. Patients were allocated to 3 parallel groups to receive topical rose oil (in the carrier of almond oil), placebo (carrier oil), or no intervention. All groups were followed for 4 weeks. All participants were evaluated by Visual Analog Scale and the Roland-Morris Disability Questionnaires to assess the pain intensity and its impact on daily activities before and after the intervention. Significant decrease in pain intensity compared to carrier oil or no intervention was observed. The rose oil also improves the functional ability of these patients in contrast with no intervention, while its effect on function is not significant compared to carrier oil. Rose oil reduced pregnancy-related low back pain intensity without any significant adverse effect. © The Author(s) 2016.

Platelet-Rich Plasma Injection With Arthroscopic Acromioplasty for Chronic Rotator Cuff Tendinopathy: A Randomized Controlled Trial.

PubMed

Carr, Andrew J; Murphy, Richard; Dakin, Stephanie G; Rombach, Ines; Wheway, Kim; Watkins, Bridget; Franklin, Sarah L

2015-12-01

Platelet-rich plasma (PRP) has been proposed to augment tendon healing through improving tissue structure during the initial repair phase. To investigate both the clinical and tissue effects of the coapplication of PRP injection with arthroscopic acromioplasty (AA) in patients with chronic rotator cuff tendinopathy. Randomized controlled trial; Level of evidence, 1. The study comprised 60 randomized patients diagnosed with rotator cuff tendinopathy (55% women) aged between 35 and 75 years. Patients were randomized to AA alone or in combination with an injection of autologous PRP into the subacromial bursa (AA + PRP). Efficacy of treatment was assessed by analysis of patient-reported outcomes up to 2 years after treatment (Oxford Shoulder Score [OSS]) and by analysis of tendon biopsy specimens taken 12 weeks after treatment. There was no significant difference in the OSS between AA alone and AA + PRP at any time point in the study. From 12 weeks onward, there was a significant increase in the OSS for both groups compared with their baseline scores (P < .001). Bonar scoring determined no significant change in tissue structure with the coapplication of PRP compared with surgery alone. The number of blood vessels and tendon cellularity were significantly decreased in tissue biopsy specimens taken from PRP-treated patients. The expression of p53-positive apoptotic cells increased after AA + PRP but decreased after AA alone. Arthroscopic acromioplasty significantly improves long-term clinical outcomes up to 2 years. The coapplication of PRP did not affect clinical outcomes. PRP significantly alters the tissue characteristics in tendons after surgery with reduced cellularity and vascularity and increased levels of apoptosis. The coapplication of PRP did not improve clinical outcomes and may have potential deleterious effects on healing tendons. ISRCTN 10464365. © 2015 The Author(s).

Increases in heart rate and serum cortisol concentrations in healthy dogs are positively correlated with an indoor waiting-room environment.

PubMed

Perego, Roberta; Proverbio, Daniela; Spada, Eva

2014-03-01

Few studies have investigated the effect of veterinary clinical procedures on the welfare of dogs, with specific emphasis on the veterinary practice environment. Clinicopathologic variables have also not been assessed in these potentially stressful situations. Similar to human clinical studies, the veterinary clinical waiting room could present a significant stress factor for dogs. The present study was designed to investigate the effect of waiting-room environment on serum cortisol and glucose alterations as well as heart rate in privately owned healthy dogs. The clinical trial included 24 healthy dogs that were divided into 2 groups: the clinical waiting-room group (A) and the control group (B) that waited outside in a garden. During the entire experiment, 18 dogs (9 dogs per group) were monitored with a human heart rate monitor fastened around the chest. After 20 minutes of waiting, blood samples were collected from all of the dogs (24 dogs) to determine serum cortisol concentration. Serum cortisol concentration and mean, maximum, and minimum heart rate were significantly higher in group A compared with group B, but there was no statistical difference in serum glucose concentrations between the 2 study groups. Results of this study suggest that the waiting room is a potentially stressful situation for dogs in clinical veterinary practice, when compared with a garden, based on the assessment of adrenal cortex function and heart rate evaluation. © 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

Clinical Performance of an Ultrahigh Resolution Chromosomal Microarray Optimized for Neurodevelopmental Disorders.

PubMed

Ho, Karen S; Twede, Hope; Vanzo, Rena; Harward, Erin; Hensel, Charles H; Martin, Megan M; Page, Stephanie; Peiffer, Andreas; Mowery-Rushton, Patricia; Serrano, Moises; Wassman, E Robert

2016-01-01

Copy number variants (CNVs) as detected by chromosomal microarray analysis (CMA) significantly contribute to the etiology of neurodevelopmental disorders, such as developmental delay (DD), intellectual disability (ID), and autism spectrum disorder (ASD). This study summarizes the results of 3.5 years of CMA testing by a CLIA-certified clinical testing laboratory 5487 patients with neurodevelopmental conditions were clinically evaluated for rare copy number variants using a 2.8-million probe custom CMA optimized for the detection of CNVs associated with neurodevelopmental disorders. We report an overall detection rate of 29.4% in our neurodevelopmental cohort, which rises to nearly 33% when cases with DD/ID and/or MCA only are considered. The detection rate for the ASD cohort is also significant, at 25%. Additionally, we find that detection rate and pathogenic yield of CMA vary significantly depending on the primary indications for testing, the age of the individuals tested, and the specialty of the ordering doctor. We also report a significant difference between the detection rate on the ultrahigh resolution optimized array in comparison to the array from which it originated. This increase in detection can significantly contribute to the efficient and effective medical management of neurodevelopmental conditions in the clinic.

A Service Evaluation of a 1-Year Dialectical Behaviour Therapy Programme for Women with Borderline Personality Disorder in a Low Secure Unit.

PubMed

Fox, Emily; Krawczyk, Kirsten; Staniford, Jessica; Dickens, Geoffrey L

2015-11-01

Previous studies about the effectiveness of Dialectical Behaviour Therapy for the treatment of Borderline Personality Disorder have had promising results. However, no previous studies have examined its effectiveness when delivered in low secure inpatient services for women. To evaluate clinical outcomes during and after a 1-year period of admission within a low secure unit for women offering a Dialectical Behaviour Therapy programme. A naturalistic, within subjects study of clinical data collected as part of routine practice was conducted. Participants were 18 consecutively admitted women who met the diagnostic criteria for Borderline Personality Disorder and had completed at least 1 year of treatment. Measures covered: risk behaviours; self-reported symptoms of Borderline Personality Disorder, and current mood and symptom experience; staff reports of clinical problems, needs and social functioning. Scores were compared between admission and at 6 months and 1 year. There was a statistically significant improvement on all 13 measures over the year's treatment. Most improvement was demonstrated between admission and 6 months. Engagement in1-year's treatment was associated with significant reduction in risk behaviours and both staff-rated and self-rated outcome measures. Some significant questions remain about which elements of the programme are most effective but the results are encouraging.

Learning clinical communication skills: outcomes of a program for professional practitioners.

PubMed

Carvalho, Irene P; Pais, Vanessa G; Almeida, Susana S; Ribeiro-Silva, Raquel; Figueiredo-Braga, Margarida; Teles, Ana; Castro-Vale, Ivone; Mota-Cardoso, Rui

2011-07-01

To assess the effects of a communication skills program on professional practitioners' performance and self-confidence in clinical interviewing. Twenty-five health professionals took 3 months of basic communication skills followed by 3 months of advanced communication skills. An additional quarter dealt with self-awareness and communication in special situations. Participants' performances were evaluated in clinical interviews with standardized patients before, during and after the program by external observers and standardized patients, using standardized instruments. Participants assessed their own confidence in their communication skills before and after the program. Data were analysed using GLM repeated-measures procedures in SPSS. Basic communication skills and self-confidence improved throughout the 6 months; competencies declined but self-confidence continued to increase 4 months later. Compared with taking no course, differences were statistically significant after the 6 months (external observers only) and 4 months later (external observers and participants). The program effectively improved communication skills, although significantly only when assessed by external observers. Four months later, effects were significant in communication skills (external observers), despite the decline and in self-confidence. While periodical enrollment in programs for the practice of communication skills may help maintain performance, more knowledge on communication and self-awareness may enhance self-confidence. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

The antibacterial effect of sage extract (Salvia officinalis) mouthwash against Streptococcus mutans in dental plaque: a randomized clinical trial.

PubMed

Beheshti-Rouy, Maryam; Azarsina, Mohadese; Rezaie-Soufi, Loghman; Alikhani, Mohammad Yousef; Roshanaie, Ghodratollah; Komaki, Samira

2015-06-01

The aim of the study was to evaluate the clinical effects of a mouthwash containing Sage (Salvia officinalis) extracts on Streptococcus mutans (SM) causing dental plaque in school-aged children. A double blind clinical trial study was conducted in a dormitory on 70 girls aged 11-14 years having the same socioeconomic and oral hygiene conditions. These students were randomly divided into 2 groups; the first group (N=35) using Sage mouthwash, and the second group (N=35) using placebo mouthwash without active any ingredients. At the baseline, plaque samples obtained from the buccal surfaces of teeth were sent to laboratory to achieve SM colony count. These tests were reevaluated after 21 days of using the mouthwashes. Statistical data analysis was performed using t-student tests with p<0.05 as the level of significance. Sage mouthwash significantly reduced the colony count (P=0.001). Average number of colonies in test group was 3900 per plaque sample at the baseline, and 300 after mouthwash application. In the control group, pre-test colony count was 4400 that was reduced to 4000; although this reduction wasn't significant. The Sage mouthwash effectively reduced the number of Streptococcus mutans in dental plaque.

The effects of clinical pilates exercises on bone mineral density, physical performance and quality of life of women with postmenopausal osteoporosis.

PubMed

Angın, Ender; Erden, Zafer; Can, Filiz

2015-01-01

The aim of this study was to investigate effects of Clinical Pilates Exercises on bone mineral density (BMD), physical performance and quality of life (QOL) in postmenopausal osteoporosis. Forty-one women were recruited to the study. The subjects were divided into two groups, as the Pilates group and the control group. Subjects were evaluated for BMD at the lumbar region. Physical performance level was measured. Pain intensity level was scored with Visual Analogue Scale. QUALEFFO-41 was used for assessing QOL. BMD values increased in the Pilates group (p < 0.05), while BMD decreased in the control group (p< 0.05). Physical performance test results showed significant increases in the Pilates group (p< 0.05) whereas there was no changes in the control group (p> 0.05). Pain intensity level in the Pilates group was significantly decreased after the exercise (p< 0.05), while it was unchanged in the control group. There were significant increases in all parameters of QOL in the Pilates group. Conversely, some parameters of QOL showed decreases in the control group (p< 0.05). Pilates Exercises is effective to increase BMD; QOL and walking distance and also beneficial to relieve pain. Physiotherapist can use Pilates Exercises for the subjects with osteoporosis in the clinics.

The use of an air filtration system in podiatry clinics.

PubMed

McLarnon, Nichola; Burrow, Gordon; Maclaren, William; Aidoo, Kofi; Hepher, Mike

2003-06-01

A small-scale study was conducted to ascertain the efficiency and effectiveness of an air filtration system for use in podiatry/chiropody clinics (Electromedia Model 35F (A), Clean Air Ltd, Scotland, UK). Three clinics were identified, enabling comparison of data between podiatry clinics in the West of Scotland. The sampling was conducted using a portable Surface Air Sampler (Cherwell Laboratories, Bicester, UK). Samples were taken on two days at three different times before and after installation of the filtration units. The global results of the study indicate the filter has a statistically significant effect on microbial counts, with an average percentage decrease of 65%. This study is the first time, to the authors' knowledge, such a system has been tested within podiatric practice.

Short term clinical effectiveness of a 0.07% cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic appliance treatment.

PubMed

Pahwa, Narinder; Kumar, Atul; Gupta, Siddharth

2011-07-01

To test the short term clinical effectiveness of commercially available 0.07%.cetylpyridinium chloride mouth rinse in patients undergoing fixed orthodontic treatment as compared to a placebo mouth rinse and patients using toothbrush and toothpaste. Forty-five subjects for this double blind study were assigned randomly into three groups of 15 each. Gingival inflammation, plaque accumulation, and bleeding on probing, were recorded at baseline (10 days after prophylaxis), and at the end of one month in all the three groups and compared. Paired t test showed significant differences in bleeding index for pre and post treatment recordings for cetylpyridinium group. Modified gingival index showed no significant difference in the cetylpyridinium group. For plaque index significant difference was found for cetylpyridinium and control groups. Cetylpyridinium mouth rinse 0.7% was found to be effective in reducing the bleeding and plaque index scores. It was not effective in reducing the modified gingival index scores. Cetylpyridinium mouth rinse 0.07% improves the oral hygiene of orthodontic patients when used as an adjunct to normal oral hygiene measures.

Orthostatic side effects of clomipramine and moclobemide during treatment for depression.

PubMed

Stage, Kurt Bjerregaard Bjerregaard

2005-01-01

From a clinical point of view, orthostatic hypotension is a significant side effect during antidepressant treatment, particularly in the case of tricyclic antidepressants (TCAs). This prospective, randomized clinical trial evaluated the effects of clomipramine and moclobemide on orthostatic blood pressure during treatment for depression. One hundred and fifteen depressed inpatients, age up to 70 years, were randomized to treatment with either moclobemide (400 mg/day) or clomipramine (150 mg/day) after 1 week of placebo treatment. Orthostatic blood pressure was measured weekly over the 6-week study period. Clomipramine, but not moclobemide, caused a statistically significant fall in systolic (F = 9.37, P = 0.0037) and diastolic orthostatic blood pressure (F = 3.74, P = 0.0017). In the clomipramine-treated group of patients, we found no correlation between subjective complaints of orthostatic dizziness and the size of systolic orthostatic blood pressure. In conclusion, this study indicates that moclobemide does not induce orthostatic side effects, which is a significant problem in treatment with TCAs. However, the choice of antidepressants depends on other factors as well, e.g. the therapeutic efficacy.

Depression or Grief? The Experience of Caregivers of People with Dementia.

ERIC Educational Resources Information Center

Walker, Rebecca J.; Pomeroy, Elizabeth C.

1996-01-01

Study of caregivers of people with dementia suggests that the depression so frequently described in the literature may not be as severe or clinically significant as previously thought and may be described as anticipatory grief. Results may assist practitioners in planning and evaluating the effectiveness of clinical interventions. (RJM)

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…

A non-invasive biomechanical device and treatment for patients following total hip arthroplasty: results of a 6-month pilot investigation

PubMed Central

2013-01-01

Background The purpose of the study was to examine the effect of a foot-worn biomechanical device on the clinical measurements and gait patterns of patients with total hip arthroplasty (THA). Methods Nineteen patients, up to 3 months post-THA, were enrolled to the study. Patients underwent a computerized gait analysis to calculate spatiotemporal parameters and completed the Western Ontario and McMaster Universities osteoarthritis index and the SF-36 health survey. Patients then began therapy with a non-invasive foot-worn biomechanical device coupled with a treatment methodology (AposTherapy). Patients received exercise guidelines and used the device daily during their regular activities at their own environment. Follow-up examinations were conducted after 4, 12, and 26 weeks of therapy. Repeated measures ANOVA was used to evaluate changes over time. The clinical significance of the treatment effect was evaluated by computing the Cohen's effect sizes (ES statistic). Results After 26 weeks of therapy, a significant improvement was seen in gait velocity (50.3%), involved step length (22.9%), and involved single limb support (16.5%). Additionally, a significant reduction in pain (85.4%) and improvement in function (81.1%) and quality of life (52.1%) were noted. Conclusions Patients following THA demonstrated a significant improvement in gait parameters and in self-assessment evaluations of pain, function, and quality of life. We recommend further RCTs to examine the effect of this therapy compared to other rehabilitation modalities following THA and compared to healthy matched controls. Trial registration Clinical trial registration number NCT01266382 PMID:23692690

Microbial environmental contamination in Italian dental clinics: A multicenter study yielding recommendations for standardized sampling methods and threshold values.

PubMed

Pasquarella, Cesira; Veronesi, Licia; Napoli, Christian; Castiglia, Paolo; Liguori, Giorgio; Rizzetto, Rolando; Torre, Ida; Righi, Elena; Farruggia, Patrizia; Tesauro, Marina; Torregrossa, Maria V; Montagna, Maria T; Colucci, Maria E; Gallè, Francesca; Masia, Maria D; Strohmenger, Laura; Bergomi, Margherita; Tinteri, Carola; Panico, Manuela; Pennino, Francesca; Cannova, Lucia; Tanzi, Marialuisa

2012-03-15

A microbiological environmental investigation was carried out in ten dental clinics in Italy. Microbial contamination of water, air and surfaces was assessed in each clinic during the five working days, for one week per month, for a three-month period. Water and surfaces were sampled before and after clinical activity; air was sampled before, after, and during clinical activity. A wide variation was found in microbial environmental contamination, both within the participating clinics and for the different sampling times. Before clinical activity, microbial water contamination in tap water reached 51,200cfu/mL (colony forming units per milliliter), and that in Dental Unit Water Systems (DUWSs) reached 872,000cfu/mL. After clinical activity, there was a significant decrease in the Total Viable Count (TVC) in tap water and in DUWSs. Pseudomonas aeruginosa was found in 2.38% (7/294) of tap water samples and in 20.06% (59/294) of DUWS samples; Legionella spp. was found in 29.96% (89/297) of tap water samples and 15.82% (47/297) of DUWS samples, with no significant difference between pre- and post-clinical activity. Microbial air contamination was highest during dental treatments, and decreased significantly at the end of the working activity (p<0.05). The microbial buildup on surfaces increased significantly during the working hours. This study provides data for the establishment of standardized sampling methods, and threshold values for contamination monitoring in dentistry. Some very critical situations have been observed which require urgent intervention. Furthermore, the study emphasizes the need for research aimed at defining effective managing strategies for dental clinics. Copyright © 2012 Elsevier B.V. All rights reserved.

Clinical study of the effectiveness of the "water of the 3 sulfates" on balanitis and balanoposthitis.

PubMed

Gonzalvo, V; Polo, A; Serrallach, F; Gutiérrez, A; Peyri, E

2015-03-01

Despite scientific literature mentions the application of "water of the 3 sulfates" (copper sulphate, zinc sulphate and alum) as a treatment for acute balanitis and balanoposthitis, no clinical trials evaluating its efficacy have been found. In our study we evaluate the efficacy of this solution in acute balanitis and balanoposthitis. A double-blind randomized study was designed to compare the efficacy of "water of the 3 sulfates" (intervention) with saline solution (control) in 50 patients (30 patients and 20 patients, respectively) who suffer from acute balanitis or balanoposthitis. Exudate, erythema, oedema, burning, and itching were the clinical parameters assessed. for all clinical parameters assessed, the outcomes obtained with "water of the 3 sulfates" are higher than control, although significant differences only have been found for exudate. in our study, the "water of the 3 sulfates" is significantly more effective than saline solution for removing exudates in acute balanitis and balanoposthitis. Tolerability was excellent in both treatments. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Effect of skill laboratory training on academic performance of medical students.

PubMed

Khan, Muhammad Alamgir; Shabbir, Faizania; Qamar, Khadija; Rajput, Tausif Ahmed

2017-05-01

To observe the effect of skill lab training on academic performance of final year medical students in terms of marks obtained in long case, short case, objective structured clinical examination and viva. The cross-sectional comparative study was conducted at Army Medical College, Rawalpindi from February to April 2015. Two batches of final year MBBS were recruited for the study. Batch 1 received conventional training, and Batch 2 received skill lab training. The performance of students was assessed by comparing the marks obtained in long case, short case, objective structured clinical examination and viva. Data was analysed using SPSS 23. Of the 335 subjects, 168(50.1%) were male and 167(49.9%) were female students with a mean age of 21.79±1.02 years. Batch 1 had 151(45%) students and Batch 2 had 184(55%). Batch 2 got significantly higher marks in long case, short case and objective structured clinical examination (p<0.05 each). Viva result was not found to be related to training (p>0.05). Acquisition of clinical skills significantly improved when medial students were trained in skill laboratories.

A prospective randomized trial comparing the clinical effectiveness and biocompatibility of heparin-coated circuits and PMEA-coated circuits in pediatric cardiopulmonary bypass.

PubMed

Itoh, Hideshi; Ichiba, Shingo; Ujike, Yoshihito; Douguchi, Takuma; Kasahara, Shingo; Arai, Sadahiko; Sano, Shunji

2016-04-01

We compared the clinical effectiveness and biocompatibility of poly-2-methoxyethyl acrylate (PMEA)-coated and heparin-coated cardiopulmonary bypass (CPB) circuits in a prospective pediatric trial. Infants randomly received heparin-coated (n=7) or PMEA-coated (n=7) circuits in elective pediatric cardiac surgery with CPB for ventricular septum defects. Clinical and hematologic variables, respiratory indices and hemodynamic changes were analyzed perioperatively. Demographic and clinical variables were similar in both groups. Leukocyte counts were significantly lower 5 minutes after CPB in the PMEA group than the heparin group. Hemodynamic data showed that PMEA caused hypotension within 5 minutes of CPB. The respiratory index was significantly higher immediately after CPB and 1 hour after transfer to the intensive care unit (ICU) in the PMEA group, as were levels of C-reactive protein 24 hours after transfer to the ICU. Our study shows that PMEA-coated circuits, unlike heparin-coated circuits, cause transient leukopenia during pediatric CPB and, perhaps, systemic inflammatory respiratory syndrome after pediatric CPB. © The Author(s) 2015.

A quasi-experimental study examining New York State's tobacco-free regulation: effects on clinical practice behaviors.

PubMed

Eby, Lillian T; Laschober, Tanja C

2013-09-01

On July 24, 2008, New York State (NYS) became the first state to require all state-funded or state-certified substance use disorder (SUD) treatment organizations to be 100% tobacco-free and offer tobacco cessation (TC) treatment. The current study used a quasi-experimental, non-equivalent control group design with a pretest and posttest to examine the effect of the NYS tobacco-free regulation on three clinical practice behaviors (use of TC-related intake procedures, use of guideline recommended counseling for TC, and pharmacotherapy availability) in a diverse sample of SUD treatment programs. Repeated cross-sectional data were collected from NYS counselors (experimental group) and non-NYS counselors (control group) approximately 4 months pre-regulation (N=282 and 659, respectively) and 10-12 months post-regulation (N=364 and 733, respectively). Using mixed-effects models, results at pre-regulation indicate no group differences in the three clinical practice behaviors. However, significant post-regulation effects were found such that the experimental group reports greater use of TC-related intake procedures, guideline recommended counseling, and availability of pharmacotherapy than the control group. Additionally, the experimental but not the control group shows increases in all three clinical practice behaviors from pre-regulation to post-regulation. We conclude that the NYS tobacco-free regulation had a significant and positive effect on promoting patient TC efforts among counselors. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Clinical effects of Angelica dahurica dressing on patients with I-II phase pressure sores.

PubMed

Gong, Fen; Niu, Junzhi; Pei, Xing

2016-11-02

Angelica dahurica is a well-known traditional Chinese Medicine (TCM), while little information is available about its effects on pressure sores. We aimed to investigate the clinical effect of Angelica dahurica on patients with I-II phase pressure sores, as well as the underlying mechanism. Patients (n = 98) with phase I and phase II pressure sores were enrolled and randomly assigned to control and treated groups. In addition to holistic nursing, patients in the control group received compound clotrimazole cream, while patients in the treated group received continuous 4 weeks of external application of Angelica dahurica dressing. Therapeutic effect was recorded, along with the levels of interleukin-8 (IL-8), epidermal growth factor (EGF), transforming growth factor (TGF)-β, and vascular endothelial growth factor (VEGF). Besides, HaCaT cells were cultured with different concentrations of Angelica dahurica, and then cell viability, clone formation numbers, cell cycle, and levels of cyclin D1 and cyclin-dependent kinase (CDK) 2 were determined. The total effective rate in the treated group was significantly higher than in the control group. Levels of IL-8, EGF, TGF-β, and VEGF were statistically increased by Angelica dahurica. In addition, the cell viability and clone formation numbers were significantly upregulated by Angelica dahurica in a dose-dependent manner. Also, the percentage of cells in G0/G1 phase, and levels of cyclin D1 and CDK2 were significantly elevated. Our results suggest that Angelica dahurica may provide an effective clinical treatment for I-II phase pressure sores.

Brief educational interventions to improve performance on novel quality metrics in ambulatory settings in Kenya: A multi-site pre-post effectiveness trial.

PubMed

Korom, Robert Ryan; Onguka, Stephanie; Halestrap, Peter; McAlhaney, Maureen; Adam, Mary

2017-01-01

The quality of primary care delivered in resource-limited settings is low. While some progress has been made using educational interventions, it is not yet clear how to sustainably improve care for common acute illnesses in the outpatient setting. Management of urinary tract infection is particularly important in resource-limited settings, where it is commonly diagnosed and associated with high levels of antimicrobial resistance. We describe an educational programme targeting non-physician health care providers and its effects on various clinical quality metrics for urinary tract infection. We used a series of educational interventions including 1) formal introduction of a clinical practice guideline, 2) peer-to-peer chart review, and 3) peer-reviewed literature describing local antimicrobial resistance patterns. Interventions were conducted for clinical officers (N = 24) at two outpatient centers near Nairobi, Kenya over a one-year period. The medical records of 474 patients with urinary tract infections were scored on five clinical quality metrics, with the primary outcome being the proportion of cases in which the guideline-recommended antibiotic was prescribed. The results at baseline and following each intervention were compared using chi-squared tests and unpaired two-tailed T-tests for significance. Logistic regression analysis was used to assess for possible confounders. Clinician adherence to the guideline-recommended antibiotic improved significantly during the study period, from 19% at baseline to 68% following all interventions (Χ2 = 150.7, p < 0.001). The secondary outcome of composite quality score also improved significantly from an average of 2.16 to 3.00 on a five-point scale (t = 6.58, p < 0.001). Interventions had different effects at different clinical sites; the primary outcome of appropriate antibiotic prescription was met 83% of the time at Penda Health, and 50% of the time at AICKH, possibly reflecting differences in onboarding and management of clinical officers. Logistic regression analysis showed that intervention stage and clinical site were independent predictors of the primary outcome (p < 0.0001), while all other features, including provider and patient age, were not significant at a conservative threshold of p < 0.05. This study shows that brief educational interventions can dramatically improve the quality of care for routine acute illnesses in the outpatient setting. Measurement of quality metrics allows for further targeting of educational interventions depending on the needs of the providers and the community. Further study is needed to expand routine measurement of quality metrics and to identify the interventions that are most effective in improving quality of care.

Health economic evaluation of patients treated for nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: secondary analysis of a multicenter randomized clinical trial of vancomycin and linezolid.

PubMed

Niederman, Michael S; Chastre, Jean; Solem, Caitlyn T; Wan, Yin; Gao, Xin; Myers, Daniela E; Haider, Seema; Li, Jim Z; Stephens, Jennifer M

2014-09-01

Results from studies comparing health care resource use (HCRU), costs of treatment, and cost-effectiveness of linezolid compared with vancomycin therapy in the treatment of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA) nosocomial pneumonia are limited in the published literature. We therefore conducted an analysis to compare the HCRU, costs of treatment, and cost-effectiveness of linezolid compared with vancomycin in the treatment of hospitalized patients with MRSA nosocomial pneumonia using data from a Phase IV clinical trial. The economic effect of moderate to severe adverse events (MSAEs) and the development of renal failure were also evaluated. We performed a post hoc analysis of data from a Phase IV, double-blind, randomized, comparator-controlled, multicenter trial that compared linezolid and vancomycin treatment in patients with MRSA nosocomial pneumonia. HCRU and costs were compared based on treatment, development of MSAEs, and development of renal failure using data from the modified intent-to-treat population. Predictors of costs were evaluated using generalized linear models. A piggyback cost-effectiveness analysis was conducted to assess the incremental cost-effectiveness ratio of linezolid versus vancomycin, given the significantly higher clinical success of linezolid compared with vancomycin found in the trial. Overall, HCRU and costs were similar between the linezolid and vancomycin treatment groups; drug costs were significantly higher and dialysis costs significantly lower for linezolid- compared with vancomycin-treated patients. Total treatment costs were approximately $8000 higher (P = .046) for patients who developed renal failure compared with those who did not. Renal failure occurred more commonly in patients randomized to receive vancomycin (15%) compared with linezolid (4%; P < .001). Region, ventilator-associated pneumonia, clinical failure, and development of renal failure were associated with significantly higher total costs. The point estimate incremental cost-effectiveness ratio for linezolid compared with vancomycin was $16,516 per treatment success, with linezolid dominant in 24% and dominated in <2% of bootstrapped samples. This phase 4 clinical trial conducted in patients with MRSA-confirmed nosocomial pneumonia reveals that linezolid- compared with vancomycin-treated patients had similar HCRU and total overall costs. Fewer patients developed renal failure during the study while taking linezolid compared with vancomycin, and patients with a documented MSAE or renal failure had increased HCRU and costs. In summary, linezolid may be a cost-effective treatment strategy in MRSA-confirmed nosocomial pneumonia. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Clinical effectiveness of a cognitive behavioral group treatment program for anxiety disorders: a benchmarking study.

PubMed

Oei, Tian P S; Boschen, Mark J

2009-10-01

Previous research has established efficacy of cognitive behavioral therapy (CBT) for anxiety disorders, yet it has not been widely assessed in routine community clinic practices. Efficacy research sacrifices external validity to achieve maximum internal validity. Recently, effectiveness research has been advocated as more ecologically valid for assessing routine clinical work in community clinics. Furthermore, there is a lack of effectiveness research in group CBT. This study aims to extend existing research on the effectiveness of CBT from individual therapy into group therapy delivery. It aimed also to examine outcome using not only symptom measures, but also measures of related symptoms, cognitions, and life quality and satisfaction. Results from a cohort of patients with various anxiety disorders demonstrated that treatment was effective in reducing anxiety symptoms to an extent comparable with other effectiveness studies. Despite this, only 43% of individuals showed reliable change, and 17% were 'recovered' from their anxiety symptoms, and the post-treatment measures were still significantly different from the level of anxiety symptoms observed in the general population.

Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis.

PubMed

Ward, S; Scope, A; Rafia, R; Pandor, A; Harnan, S; Evans, P; Wyld, L

2013-10-01

Gene expression profiling (GEP) and expanded immunohistochemistry (IHC) tests aim to improve decision-making relating to adjuvant chemotherapy for women with early breast cancer. The aim of this report is to assess the clinical effectiveness and cost-effectiveness of nine GEP and expanded IHC tests compared with current prognostic tools in guiding the use of adjuvant chemotherapy in patients with early breast cancer in England and Wales. The nine tests are BluePrint, Breast Cancer Index (BCI), IHC4, MammaPrint, Mammostrat, NPI plus (NPI+), OncotypeDX, PAM50 and Randox Breast Cancer Array. Databases searched included MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE and The Cochrane Library. Databases were searched from January 2009 to May 2011 for the OncotypeDX and MammaPrint tests and from January 2002 to May 2011 for the other tests. A systematic review of the evidence on clinical effectiveness (analytical validity, clinical validity and clinical utility) and cost-effectiveness was conducted. An economic model was developed to evaluate the cost-effectiveness of adjuvant chemotherapy treatment guided by four of the nine test (OncotypeDX, IHC4, MammaPrint and Mammostrat) compared with current clinical practice in England and Wales, using clinicopathological parameters, in women with oestrogen receptor-positive (ER+), lymph node-negative (LN-), human epidermal growth factor receptor type 2-negative (HER2-) early breast cancer. The literature searches for clinical effectiveness identified 5993 citations, of which 32 full-text papers or abstracts (30 studies) satisfied the criteria for the effectiveness review. A narrative synthesis was performed. Evidence for OncotypeDX supported the prognostic capability of the test. There was some evidence on the impact of the test on decision-making and to support the case that OncotypeDX predicts chemotherapy benefit; however, few studies were UK based and limitations in relation to study design were identified. Evidence for MammaPrint demonstrated that the test score was a strong independent prognostic factor, but the evidence is non-UK based and is based on small sample sizes. Evidence on the Mammostrat test showed that the test was an independent prognostic tool for women with ER+, tamoxifen-treated breast cancer. The three studies appeared to be of reasonable quality and provided data from a UK setting (one study). One large study reported on clinical validity of the IHC4 test, with IHC4 score a highly significant predictor of distant recurrence. This study included data from a UK setting and appeared to be of reasonable quality. Evidence for the remaining five tests (PAM50, NPI+, BCI, BluePrint and Randox) was limited. The economic analysis suggests that treatment guided using IHC4 has the greatest potential to be cost-effective at a £20,000 threshold, given the low cost of the test; however, further research is needed on the analytical validity and clinical utility of IHC4, and the exact cost of the test needs to be confirmed. Current limitations in the evidence base produce significant uncertainty in the results. OncotypeDX has a more robust evidence base, but further evidence on its impact on decision-making in the UK and the predictive ability of the test in an ER+, LN-, HER- population receiving current drug regimens is needed. For MammaPrint and Mammostrat there were significant gaps in the available evidence and the estimates of cost-effectiveness produced were not considered to be robust by the External Assessment Group. Methodological weaknesses in the clinical evidence base relate to heterogeneity of patient cohorts and issues arising from the retrospective nature of the evidence. Further evidence is required on the clinical utility of all of the tests and on UK-based populations. A key area of uncertainty relates to whether the tests provide prognostic or predictive ability. The clinical evidence base for OncotypeDX is considered to be the most robust. The economic analysis suggested that treatment guided using IHC4 has the most potential to be cost-effective at a threshold of £20,000; however, the evidence base to support IHC4 needs significant further research. PROSPERO 2011:CRD42011001361, available from www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42011001361.

EMG of the hip adductor muscles in six clinical examination tests.

PubMed

Lovell, Gregory A; Blanch, Peter D; Barnes, Christopher J

2012-08-01

To assess activation of muscles of hip adduction using EMG and force analysis during standard clinical tests, and compare athletes with and without a prior history of groin pain. Controlled laboratory study. 21 male athletes from an elite junior soccer program. Bilateral surface EMG recordings of the adductor magnus, adductor longus, gracilis and pectineus as well as a unilateral fine-wire EMG of the pectineus were made during isometric holds in six clinical examination tests. A load cell was used to measure force data. Test type was a significant factor in the EMG output for all four muscles (all muscles p < 0.01). EMG activation was highest in Hips 0 or Hips 45 for adductor magnus, adductor longus and gracilis. EMG activation for pectineus was highest in Hips 90. Injury history was a significant factor in the EMG output for the adductor longus (p < 0.05), pectineus (p < 0.01) and gracilis (p < 0.01) but not adductor magnus. For force data, clinical test type was a significant factor (p < 0.01) with Hips 0 being significantly stronger than Hips 45, Hips 90 and Side lay. BMI (body mass index) was a significant factor (p < 0.01) for producing a higher force. All other factors had no significant effect on the force outputs. Hip adduction strength assessment is best measured at hips 0 (which produced most force) or 45° flexion (which generally gave the highest EMG output). Muscle EMG varied significantly with clinical test position. Athletes with previous groin injury had a significant fall in some EMG outputs. Copyright © 2011 Elsevier Ltd. All rights reserved.

Effectiveness of physical therapy for patients with neck pain: an individualized approach using a clinical decision-making algorithm.

PubMed

Wang, Wendy T J; Olson, Sharon L; Campbell, Anne H; Hanten, William P; Gleeson, Peggy B

2003-03-01

The purpose of this study was to determine the effectiveness of an individualized physical therapy intervention in treating neck pain based on a clinical reasoning algorithm. Treatment effectiveness was examined by assessing changes in impairment, physical performance, and disability in response to intervention. One treatment group of 30 patients with neck pain completed physical therapy treatment. The control group of convenience was formed by a cohort group of 27 subjects who also had neck pain but did not receive treatment for various reasons. There were no significant differences between groups in demographic data and the initial test scores of the outcome measures. A quasi-experimental, nonequivalent, pretest-posttest control group design was used. A physical therapist rendered an eclectic intervention to the treatment group based on a clinical decision-making algorithm. Treatment outcome measures included the following five dependent variables: cervical range of motion, numeric pain rating, timed weighted overhead endurance, the supine capital flexion endurance test, and the Patient Specific Functional Scale. Both the treatment and control groups completed the initial and follow-up examinations, with an average duration of 4 wk between tests. Five mixed analyses of variance with follow-up tests showed a significant difference for all outcome measures in the treatment group compared with the control group. After an average 4 wk of physical therapy intervention, patients in the treatment group demonstrated statistically significant increases of cervical range of motion, decrease of pain, increases of physical performance measures, and decreases in the level of disability. The control group showed no differences in all five outcome variables between the initial and follow-up test scores. This study delineated algorithm-based clinical reasoning strategies for evaluating and treating patients with cervical pain. The algorithm can help clinicians classify patients with cervical pain into clinical patterns and provides pattern-specific guidelines for physical therapy interventions. An organized and specific physical therapy program was effective in improving the status of patients with neck pain.

Effects of benazepril in the treatment of feline hypertrophic cardiomyopathy Results of a prospective, open-label, multicenter clinical trial.

PubMed

Amberger, C N; Glardon, O; Glaus, T; Hörauf, A; King, J N; Schmidli, H; Schröter, L; Lombard, C W

1999-05-01

To evaluate the efficacy of benazepril on clinical signs and echocardiographic parameters in cats with primary hypertrophic cardiomyopathy (HCM). ACE-inhibitors have positive effects in man with HCM, and contribute to a reduction of myocardial hypertrophy. Addition of an ACE-inhibitor to the standard treatment of HCM in cats may have beneficial effects. A total of 32 cats which were either asymptomatic or in stabilised congestive heart failure (ISACHC* class Ib, II or IIIa) were included in a one-year, prospective, open-label, clinical trial in 5 centres in Switzerland. 28 of these cats were allocated to one of two treatment groups: 1) standard therapy (ST) alone (n=9), consisting of a long-acting formulation of diltiazem (6-9 mg/kg sid) and optional acetylsalicylic acid (50 mg twice weekly, or 2) the same ST plus benazepril (0.33 - 0.75 mg/kg sid, n=19). Cats treated with benazepril showed a statistically significant decrease (mean +/- SEM, 0.11 +/- 0.03 mm/month, p = 0.002) in the left ventricular wall thickness (LVWD) from baseline, while no change (increase of 0.02 +/- 0.04 mm/month, p=0.66) was observed in cats on ST alone. Differences in LVWD between the two groups reached statistical significance (p=0.02). Benazepril treated cats showed more improvement in clinical signs (20-53%) than cats receiving ST alone (0-20%) but differences between the groups were not statistically significant (p>0.1). No change in septal thickness (IVSD) or left atrial to aortic root ratio (LA/Ao) was observed in either group. Benazepril had some beneficial effects on clinical signs and cardiac remodelling in cats with HCM and was well tolerated. These results, however, need to be confirmed in additional controlled studies. * ISACHC classification is described in the previous paper (Bench-study).

The effect of computer-assisted learning versus conventional teaching methods on the acquisition and retention of handwashing theory and skills in pre-qualification nursing students: a randomised controlled trial.

PubMed

Bloomfield, Jacqueline; Roberts, Julia; While, Alison

2010-03-01

High quality health care demands a nursing workforce with sound clinical skills. However, the clinical competency of newly qualified nurses continues to stimulate debate about the adequacy of current methods of clinical skills education and emphasises the need for innovative teaching strategies. Despite the increasing use of e-learning within nurse education, evidence to support its use for clinical skills teaching is limited and inconclusive. This study tested whether nursing students could learn and retain the theory and skill of handwashing more effectively when taught using computer-assisted learning compared with conventional face-to-face methods. The study employed a two group randomised controlled design. The intervention group used an interactive, multimedia, self-directed computer-assisted learning module. The control group was taught by an experienced lecturer in a clinical skills room. Data were collected over a 5-month period between October 2004 and February 2005. Knowledge was tested at four time points and handwashing skills were assessed twice. Two-hundred and forty-two first year nursing students of mixed gender; age; educational background and first language studying at one British university were recruited to the study. Participant attrition increased during the study. Knowledge scores increased significantly from baseline in both groups and no significant differences were detected between the scores of the two groups. Skill performance scores were similar in both groups at the 2-week follow-up with significant differences emerging at the 8-week follow-up in favour of the intervention group, however, this finding must be interpreted with caution in light of sample size and attrition rates. The computer-assisted learning module was an effective strategy for teaching both the theory and practice of handwashing to nursing students and in this study was found to be at least as effective as conventional face-to-face teaching methods. Copyright 2009 Elsevier Ltd. All rights reserved.

Class III antiarrhythmic agents in cardiac failure: lessons from clinical trials with a focus on the Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiaca en Argentina (GESICA).

PubMed

Doval, H C

1999-11-04

The results of previous clinical trials, in a variety of clinical settings, showed that class I agents may consistently increase mortality in sharp contrast to the effects of beta blockers. Attention has therefore shifted to class III compounds for potential beneficial effects on long-term mortality among patients with underlying cardiac disease. Clinical trials with d-sotalol, the dextro isomer (devoid of beta blockade) of sotalol, showed increased mortality in patients with low ejection fraction after myocardial infarction and in those with heart failure; whereas in the case of dofetilide, the impact on mortality was neutral. Because of the complex effects of its actions as an alpha-adrenergic blocker and a class III agent, the impact on mortality of amiodarone in patients with heart failure is of particular interest. A meta-analysis of 13 clinical trials revealed significant reductions in all-cause and cardiac mortality among patients with heart failure or previous myocardial infarction. Among these were 5 controlled clinical trials that investigated the effects of amiodarone on mortality among patients with heart failure. None of these trials was large relative to the beta-blocker trials in the postinfarction patients. However, the larger 2 of the 5 amiodarone trials produced discordant effects on mortality, neutral in one and significantly positive in the other. Some of the differences may be accounted for by the differences in eligibility criteria and baseline characteristics. Future trials that may be undertaken to resolve the discrepancies may need to allow for the newer findings on the effects of concomitant beta blockers, implantable devices, and possibly, spironolactone. All these modalities of treatment have been shown in controlled clinical trials to augment survival in patients with impaired ventricular function or manifest heart failure. Additional trials, some of which are currently in progress, compare amiodarone with implantable devices and other therapeutic interventions, and should help to clarify the optimal management strategy for patients with underlying heart failure.

Dexmedetomidine oromucosal gel for noise-associated acute anxiety and fear in dogs-a randomised, double-blind, placebo-controlled clinical study.

PubMed

Korpivaara, M; Laapas, K; Huhtinen, M; Schöning, B; Overall, K

2017-04-08

The aim of this randomised, double-blind, placebo-controlled, clinical-field study was to evaluate the effect of dexmedetomidine oromucosal gel at subsedative doses in alleviation of noise-associated acute anxiety and fear in dogs. On New Year's Eve, 182 dogs with a history of acute anxiety and fear associated with fireworks received treatment as needed up to five times: 89 dogs received dexmedetomidine and 93 dogs received placebo. For the primary efficacy variables, dog owners assessed the overall treatment effect as well as signs and extent of anxiety and fear. The overall treatment effect was statistically significant (P<0.0001). An excellent or good treatment effect was reported for a higher proportion of dogs treated with dexmedetomidine (64/89, 72 per cent) than those receiving placebo (34/93, 37 per cent). Additionally, dexmedetomidine-treated dogs expressed significantly (P<0.0314) fewer signs of fear and anxiety despite the noise of fireworks. No local tolerance or clinical safety concerns occurred during the study. This study demonstrated that oromucosal dexmedetomidine at subsedative doses alleviates noise-associated acute anxiety and fear in dogs. British Veterinary Association.

Comparative effectiveness of instructional methods: oral and pharyngeal cancer examination.

PubMed

Clark, Nereyda P; Marks, John G; Sandow, Pamela R; Seleski, Christine E; Logan, Henrietta L

2014-04-01

This study compared the effectiveness of different methods of instruction for the oral and pharyngeal cancer examination. A group of thirty sophomore students at the University of Florida College of Dentistry were randomly assigned to three training groups: video instruction, a faculty-led hands-on instruction, or both video and hands-on instruction. The training intervention involved attending two sessions spaced two weeks apart. The first session used a pretest to assess students' baseline didactic knowledge and clinical examination technique. The second session utilized two posttests to assess the comparative effectiveness of the training methods on didactic knowledge and clinical technique. The key findings were that students performed the clinical examination significantly better with the combination of video and faculty-led hands-on instruction (p<0.01). All students improved their clinical exam skills, knowledge, and confidence in performing the oral and pharyngeal cancer examination independent of which training group they were assigned. Utilizing both video and interactive practice promoted greater performance of the clinical technique on the oral and pharyngeal cancer examination.

The impact on bone tissues of immediate implant-supported mandibular overdentures with cusped and cuspless teeth

PubMed Central

Arafa, Khalid A.

2016-01-01

Objectives: To examine the effects on bone tissues of immediate implant-supported mandibular overdentures with cusped or cuspless teeth. Methods: A randomized controlled trial was conducted at the Dental Clinic, Faculty of Dentistry, Al-Azhar University, Assiut Branch, Egypt, over a 12-month period from September 2013 to September 2014. Twenty patients were treated with immediate implant-supported overdentures: one group received overdentures with cusped teeth, and the other group received overdentures with cuspless teeth. The rate of implant success was assessed clinically and radiographically at 3, 6, 9, and 12 months. The data were collected by a questionnaire, an observation checklist, and radiography. The data were then analyzed using computerized methods. Results: Overdentures with cusped teeth showed a significant improvement in the clinical criteria, including the absence of clinical implant mobility, pain, and bone resorption, while the clinical criteria for the absence of peri-implant radiolucency were insignificantly different between the 2 groups (p>0.05). There were no significant differences in the clinical evaluations for bone levels at the time of insertion or 3 months after insertions, while significant differences were found at 6, 9, and 12 months after insertion. Conclusion: Overdentures with cusped teeth supported by immediate implants were found superior regarding many clinical criteria than those cuspless counterparts. PMID:26739979

The impact on bone tissues of immediate implant-supported mandibular overdentures with cusped and cuspless teeth.

PubMed

Arafa, Khalid A

2016-01-01

To examine the effects on bone tissues of immediate implant-supported mandibular overdentures with cusped or cuspless teeth. A randomized controlled trial was conducted at the Dental Clinic, Faculty of Dentistry, Al-Azhar University, Assiut Branch, Egypt, over a 12-month period from September 2013 to September 2014. Twenty patients were treated with immediate implant-supported overdentures: one group received overdentures with cusped teeth, and the other group received overdentures with cuspless teeth. The rate of implant success was assessed clinically and radiographically at 3, 6, 9, and 12 months. The data were collected by a questionnaire, an observation checklist, and radiography. The data were then analyzed using computerized methods.  Overdentures with cusped teeth showed a significant improvement in the clinical criteria, including the absence of clinical implant mobility, pain, and bone resorption, while the clinical criteria for the absence of peri-implant radiolucency were insignificantly different between the 2 groups (p more than 0.05). There were no significant differences in the clinical evaluations for bone levels at the time of insertion or 3 months after insertions, while significant differences were found at 6, 9, and 12 months after insertion. Overdentures with cusped teeth supported by immediate implants were found superior regarding many clinical criteria than those cuspless counterparts.

Effects of alpha-lipoic acid supplementation on C-reactive protein level: A systematic review and meta-analysis of randomized controlled clinical trials.

PubMed

Saboori, S; Falahi, E; Eslampour, E; Zeinali Khosroshahi, M; Yousefi Rad, E

2018-04-17

The aim of this meta-analysis was to assess effects of alpha-lipoic acid supplementation on C-reactive protein (CRP) levels in clinical trial studies. A systematic search was carried out on clinical trial studies published in PubMed, ISI Web of Science, Cochrane Library and Scopus databases completed by manual search on reference list of eligible studies accomplished by November 4, 2017. Of a total number of 508 studies found in the first step of literature search, only 11 were included with 264 participants in supplementation groups and 287 in control groups. Estimated pooled random effects size analysis showed a significant reducing effect of alpha-lipoic acid supplementation on CRP level (-0.72 mg/l, 95% CI; -1.4, -0.04; P = 0.03) with a significant heterogeneity between the selected studies. Sub-group analysis showed that alpha-lipoic acid supplementation could significantly reduce serum CRP level when the baseline CRP level was greater than 3 mg/l (-1.02 mg/l, 95% CI: -1.3, -0.73) and when trial duration was >8 weeks (-0.99 mg/l, 95% CI: -1.29, -0.70). Results of subgroup analysis also showed that alpha lipoic acid supplementation could decrease CRP level only in non-diabetic patients (-1.02 mg/l, 95% CI: -1.31, -0.74). Results of the current meta-analysis study showed that alpha-lipoic acid supplementation could significantly decrease CRP level in patients with elevated levels of this inflammatory marker. Copyright © 2018 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.