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.

Abdominal pain endpoints currently recommended by the FDA and EMA for adult patients with irritable bowel syndrome may not be reliable in children.

PubMed

Saps, M; Lavigne, J V

2015-06-01

The Food and Drug Administration (FDA) recommended ≥30% decrease on patient-reported outcomes for pain be considered clinically significant in clinical trials for adults with irritable bowel syndrome. This percent change approach may not be appropriate for children. We compared three alternate approaches to determining clinically significant reductions in pain among children. 80 children with functional abdominal pain participated in a study of the efficacy of amitriptyline. Endpoints included patient-reported estimates of feeling better, and pain Visual Analog Scale (VAS). The minimum clinically important difference in pain report was calculated as (i) mean change in VAS score for children reporting being 'better'; (ii) percent changes in pain (≥30% and ≥50%) on the VAS; and (iii) statistically reliable changes on the VAS for 68% and 95% confidence intervals. There was poor agreement between the three approaches. 43.6% of the children who met the FDA ≥30% criterion for clinically significant change did not achieve a reliable level of improvement (95% confidence interval). Children's self-reported ratings of being better may not be statistically reliable. A combined approach in which children must report improvement as better and achieve a statistically significant change may be more appropriate for outcomes in clinical trials. © 2015 John Wiley & Sons Ltd.

Does catatonic schizophrenia improve faster with electroconvulsive therapy than other subtypes of schizophrenia?

PubMed

Thirthalli, Jagadisha; Phutane, Vivek H; Muralidharan, Kesavan; Kumar, Channaveerachari Naveen; Munishwar, Bharat; Baspure, Prashant; Gangadhar, Bangalore N

2009-01-01

Electroconvulsive therapy (ECT) is generally recommended for treating catatonic schizophrenia. Non-catatonic schizophrenia patients also receive ECT. We compared the speed of response to ECT among patients with catatonic and other subtypes of schizophrenia. Consecutive schizophrenia patients referred for ECT within 3 months of starting antipsychotic treatment were studied (19 with catatonic and 34 with non-catatonic schizophrenia). Nurse's Observation Scale for Inpatient Evaluation (NOSIE-30) and Clinical Global Impression (CGI) were used to rate improvement. Referring psychiatrists stopped ECTs based on clinical impression of improvement. Total number of ECTs was taken as an indirect measure of speed of response. NOSIE-30 scores were compared using repeated measures analysis of variance. Catatonic schizophrenia patients required significantly fewer ECTs to achieve clinically significant improvement. There was a significant group x occasion effect in NOSIE scores, suggesting faster response to ECT in the catatonia group (F=41.6; P<0.001). Survival analysis suggested that patients with catatonic schizophrenia required significantly fewer ECTs (one less session on an average) to achieve clinical improvement (Log-rank statistic =5.31; P=0.02). Catatonic schizophrenia responds faster to ECT than non-catatonic schizophrenia. However, the magnitude of the difference is modest.

Reassessment of hypnotic symptom removal by Freud and Bernheim.

PubMed

Ball, Thomas S

2006-10-01

As demonstrations of clinical efficacy, cases reported by Freud and Bernheim reveal an intrinsic advantage of hypnotic symptom removal over therapies requiring extended periods to achieve significant outcomes. They also lend support to Weitzenhoffer's survey of therapeutic results achieved during the classical (pre-1900) period.

PSA Nadir of <0.5 ng/mL Following Brachytherapy for Early-Stage Prostate Adenocarcinoma is Associated With Freedom From Prostate-Specific Antigen Failure

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

Ko, Eric C.; Stone, Nelson N.; Department of Urology, Mount Sinai Medical Center, New York, NY

2012-06-01

Purpose: Because limited information exists regarding whether the rate or magnitude of PSA decline following brachytherapy predicts long-term clinical outcomes, we evaluated whether achieving a prostate-specific antigen (PSA) nadir (nPSA) <0.5 ng/mL following brachytherapy is associated with decreased PSA failure and/or distant metastasis. Methods and Materials: We retrospectively analyzed our database of early-stage prostate adenocarcinoma patients who underwent brachytherapy, excluding those receiving androgen-deprivation therapy and those with <2 years follow-up. Median and mean pretreatment PSA were 6 ng/mL and 7.16 ng/mL, respectively. By clinical stage, 775 were low risk ({<=}T2a), 126 were intermediate risk (T2b), and 20 were high riskmore » (>T2b). By Gleason score, 840 were low risk ({<=}6), 71 were intermediate risk (7), and 10 were high risk (>7). Patients were treated with brachytherapy only (I-125, n = 779, or Pd-103, n = 47), or brachytherapy + external-beam radiation therapy (n = 95). Median follow-up was 6.3 years. We noted whether nPSA <0.5 ng/mL was achieved and the time to achieve this nadir and tested for associations with pretreatment risk factors. We also determined whether this PSA endpoint was associated with decreased PSA failure or distant metastasis. Results: Absence of high-risk factors in clinical stage ({<=}T2b), Gleason score ({<=}7), and pretreatment PSA ({<=}20 ng/mL) was significantly associated with achieving nPSA <0.5 ng/mL. By Kaplan-Meier analysis, patients achieving nPSA <0.5 ng/mL had significantly higher long-term freedom from biochemical failure (FFBF) than nonresponders (5-year FFBF: 95.2 {+-} 0.8% vs. 71.5 {+-} 6.7%; p < 0.0005). Among responders, those who achieved nPSA <0.5 ng/mL in {<=}5 years had higher FFBF than those requiring >5 years (5-year FFBF: 96.7 {+-} 0.7% vs. 80.8 {+-} 4.6%; p < 0.0005). On multivariate analysis, patients who achieved nPSA <0.5 ng/mL in {<=}5 years had significantly higher FFBF than other patients. Conclusions: Pretreatment risk factors (clinical tumor stage, Gleason score, pretreatment PSA) strongly predict for patients achieving nPSA <0.5 ng/mL following brachytherapy, and this cohort had significantly higher long-term FFBF.« less

PSA nadir of <0.5 ng/mL following brachytherapy for early-stage prostate adenocarcinoma is associated with freedom from prostate-specific antigen failure.

PubMed

Ko, Eric C; Stone, Nelson N; Stock, Richard G

2012-06-01

Because limited information exists regarding whether the rate or magnitude of PSA decline following brachytherapy predicts long-term clinical outcomes, we evaluated whether achieving a prostate-specific antigen (PSA) nadir (nPSA) <0.5 ng/mL following brachytherapy is associated with decreased PSA failure and/or distant metastasis. We retrospectively analyzed our database of early-stage prostate adenocarcinoma patients who underwent brachytherapy, excluding those receiving androgen-deprivation therapy and those with <2 years follow-up. Median and mean pretreatment PSA were 6 ng/mL and 7.16 ng/mL, respectively. By clinical stage, 775 were low risk (≤ T2a), 126 were intermediate risk (T2b), and 20 were high risk (>T2b). By Gleason score, 840 were low risk (≤ 6), 71 were intermediate risk (7), and 10 were high risk (>7). Patients were treated with brachytherapy only (I-125, n = 779, or Pd-103, n = 47), or brachytherapy + external-beam radiation therapy (n = 95). Median follow-up was 6.3 years. We noted whether nPSA <0.5 ng/mL was achieved and the time to achieve this nadir and tested for associations with pretreatment risk factors. We also determined whether this PSA endpoint was associated with decreased PSA failure or distant metastasis. Absence of high-risk factors in clinical stage (≤ T2b), Gleason score (≤ 7), and pretreatment PSA (≤ 20 ng/mL) was significantly associated with achieving nPSA <0.5 ng/mL. By Kaplan-Meier analysis, patients achieving nPSA <0.5 ng/mL had significantly higher long-term freedom from biochemical failure (FFBF) than nonresponders (5-year FFBF: 95.2 ± 0.8% vs. 71.5 ± 6.7%; p < 0.0005). Among responders, those who achieved nPSA <0.5 ng/mL in ≤ 5 years had higher FFBF than those requiring >5 years (5-year FFBF: 96.7 ± 0.7% vs. 80.8 ± 4.6%; p < 0.0005). On multivariate analysis, patients who achieved nPSA <0.5 ng/mL in ≤ 5 years had significantly higher FFBF than other patients. Pretreatment risk factors (clinical tumor stage, Gleason score, pretreatment PSA) strongly predict for patients achieving nPSA <0.5 ng/mL following brachytherapy, and this cohort had significantly higher long-term FFBF. Copyright © 2012 Elsevier Inc. All rights reserved.

Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results

PubMed Central

Akbar, Ayesha; Hart, Ailsa; Subramanian, Sreedhar; Bommelaer, Gilles; Baumgart, Daniel C.; Grimaud, Jean-Charles; Cadiot, Guillaume; Makins, Richard; Hoque, Syed; Bouguen, Guillaume; Bonaz, Bruno

2016-01-01

Background and Aims: Patients with active, steroid-dependent ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologic therapies have limited treatment options. Adacolumn, a granulocyte/monocyte adsorptive apheresis device, has shown clinical benefit in these patients. This study aimed to provide additional clinical data regarding the safety and efficacy of Adacolumn in this patient subgroup. Methods: This single-arm, open-label, multicentre trial [ART] was conducted at 18 centres across the UK, France, and Germany. Eligible patients were 18–75 years old with moderate-to-severe, steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics. Patients received ≥ 5 weekly apheresis sessions with Adacolumn. The primary endpoint was clinical remission rate [clinical activity index ≤ 4] at Week 12. Results: In all, 86 patients were enrolled. At Week 12, 33/84 [39.3%] of patients in the intention-to-treat population achieved clinical remission, with 47/84 [56.0%] achieving a clinical response [clinical activity index reduction of ≥ 3]. Clinical remission was achieved in 30.0% of patients with previous immunosuppressant and biologic failure; steroid-free clinical remission and response were observed in 22.6% and 35.7% of these patients, respectively. Quality of life [Short Health Scale] significantly improved at Week 12 [p < 0.0001]. The majority of adverse events were of mild/moderate intensity. Conclusions: At Week 12, Adacolumn provided significant clinical benefit in a large cohort of steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment, with a favourable safety profile. These results are consistent with previous studies and support Adacolumn use in this difficult-to-treat patient subgroup. PMID:26818659

Achieving progress through clinical governance? A national study of health care managers' perceptions in the NHS in England

PubMed Central

Freeman, T; Walshe, K

2004-01-01

Background: A national cross sectional study was undertaken to explore the perceptions concerning the importance of, and progress in, aspects of clinical governance among board level and directorate managers in English acute, ambulance, and mental health/learning disabilities (MH/LD) trusts. Participants: A stratified sample of acute, ambulance, and mental health/learning disabilities trusts in England (n = 100), from each of which up to 10 board level and 10 directorate level managers were randomly sampled. Methods: Fieldwork was undertaken between April and July 2002 using the Organisational Progress in Clinical Governance (OPCG) schedule to explore managers' perceptions of the importance of, and organisational achievement in, 54 clinical governance competency items in five aggregated domains: improving quality; managing risks; improving staff performance; corporate accountability; and leadership and collaboration. The difference between ratings of importance and achievement was termed a shortfall. Results: Of 1916 individuals surveyed, 1177 (61.4%) responded. The competency items considered most important and recording highest perceived achievement related to corporate accountability structures and clinical risks. The highest shortfalls between perceived importance and perceived achievement were reported in joint working across local health communities, feedback of performance data, and user involvement. When aggregated into domains, greatest achievement was perceived in the assurance related areas of corporate accountability and risk management, with considerably less perceived achievement and consequently higher shortfalls in quality improvement and leadership and collaboration. Directorate level managers' perceptions of achievement were found to be significantly lower than those of their board level colleagues on all domains other than improving performance. No differences were found in perceptions of achievement between different types of trusts, or between trusts at different stages in the Commission for Health Improvement (CHI) review cycle. Conclusions: While structures and systems for clinical governance seem well established, there is more perceived progress in areas concerned with quality assurance than quality improvement. This study raises some uncomfortable questions about the impact of CHI review visits. PMID:15465936

Achieving progress through clinical governance? A national study of health care managers' perceptions in the NHS in England.

PubMed

Freeman, T; Walshe, K

2004-10-01

A national cross sectional study was undertaken to explore the perceptions concerning the importance of, and progress in, aspects of clinical governance among board level and directorate managers in English acute, ambulance, and mental health/learning disabilities (MH/LD) trusts. A stratified sample of acute, ambulance, and mental health/learning disabilities trusts in England (n = 100), from each of which up to 10 board level and 10 directorate level managers were randomly sampled. Fieldwork was undertaken between April and July 2002 using the Organisational Progress in Clinical Governance (OPCG) schedule to explore managers' perceptions of the importance of, and organisational achievement in, 54 clinical governance competency items in five aggregated domains: improving quality; managing risks; improving staff performance; corporate accountability; and leadership and collaboration. The difference between ratings of importance and achievement was termed a shortfall. Of 1916 individuals surveyed, 1177 (61.4%) responded. The competency items considered most important and recording highest perceived achievement related to corporate accountability structures and clinical risks. The highest shortfalls between perceived importance and perceived achievement were reported in joint working across local health communities, feedback of performance data, and user involvement. When aggregated into domains, greatest achievement was perceived in the assurance related areas of corporate accountability and risk management, with considerably less perceived achievement and consequently higher shortfalls in quality improvement and leadership and collaboration. Directorate level managers' perceptions of achievement were found to be significantly lower than those of their board level colleagues on all domains other than improving performance. No differences were found in perceptions of achievement between different types of trusts, or between trusts at different stages in the Commission for Health Improvement (CHI) review cycle. While structures and systems for clinical governance seem well established, there is more perceived progress in areas concerned with quality assurance than quality improvement. This study raises some uncomfortable questions about the impact of CHI review visits.

[Achieving an educative strategy in undergraduate medical interns with respect to patients with diabetes].

PubMed

Medina-Figueroa, Alda María; Espinosa-Alarcón, Patricia Atzimba

2007-01-01

To estimate the achievement of an educative strategy that promoted participation of the development of the clinical aptitude of undergraduate medical students with regard to patients with diabetes. We conducted a quasi-experimental study with two groups of undergraduate medical students. We validated an instrument to explore clinical attitude concerning diabetes mellitus (ACDIME) with 30 items for each of six indicators. The instrument was applied at two general hospitals, before and after carrying out the educative strategies. In the experimental group, we conducted an educative strategy that promotes participation in developing clinical aptitude, while the customary strategy was developed in the control group. ACDIME consistency was 0.80. Both study groups were similar before the educative strategies (p = 0.165). Statistically significant differences existed after the strategies in all indicators were evaluated, in favor of the experimental group. The tendency to change, with a criterion of 50% or more, was only statistically significant in the experimental group (p < 0.0001). The ACDIME instrument is valid and reliable. The educative strategy that promoted participation is clearly superior to the customary strategy with regard to achievement.

Limited utility of routine surveillance imaging for classical Hodgkin lymphoma patients in first complete remission.

PubMed

Pingali, Sai Ravi; Jewell, Sarah W; Havlat, Luiza; Bast, Martin A; Thompson, Jonathan R; Eastwood, Daniel C; Bartlett, Nancy L; Armitage, James O; Wagner-Johnston, Nina D; Vose, Julie M; Fenske, Timothy S

2014-07-15

The objective of this study was to compare the outcomes of patients with classical Hodgkin lymphoma (cHL) who achieved complete remission with frontline therapy and then underwent either clinical surveillance or routine surveillance imaging. In total, 241 patients who were newly diagnosed with cHL between January 2000 and December 2010 at 3 participating tertiary care centers and achieved complete remission after first-line therapy were retrospectively analyzed. Of these, there were 174 patients in the routine surveillance imaging group and 67 patients in the clinical surveillance group, based on the intended mode of surveillance. In the routine surveillance imaging group, the intended plan of surveillance included computed tomography and/or positron emission tomography scans; whereas, in the clinical surveillance group, the intended plan of surveillance was clinical examination and laboratory studies, and scans were obtained only to evaluate concerning signs or symptoms. Baseline patient characteristics, prognostic features, treatment records, and outcomes were collected. The primary objective was to compare overall survival for patients in both groups. For secondary objectives, we compared the success of second-line therapy and estimated the costs of imaging for each group. After 5 years of follow-up, the overall survival rate was 97% (95% confidence interval, 92%-99%) in the routine surveillance imaging group and 96% (95% confidence interval, 87%-99%) in the clinical surveillance group (P = .41). There were few relapses in each group, and all patients who relapsed in both groups achieved complete remission with second-line therapy. The charges associated with routine surveillance imaging were significantly higher than those for the clinical surveillance strategy, with no apparent clinical benefit. Clinical surveillance was not inferior to routine surveillance imaging in patients with cHL who achieved complete remission with frontline therapy. Routine surveillance imaging was associated with significantly increased estimated imaging charges. © 2014 American Cancer Society.

A Study of the Influence of Academic Achievement on the Resident Selection Process.

ERIC Educational Resources Information Center

Goller, William L.

1980-01-01

Discusses a study, which indicated a significant difference between residency applicants considered finalists after their interview was completed, and those considered nonfinalists (among applicants representing differing levels of academic achievement as measured by National Board of Podiatry Examiners examination scores and clinical evaluation…

Achieving Core Indicators for HIV Clinical Care Among New Patients at an Urban HIV Clinic.

PubMed

Greer, Gillian A; Tamhane, Ashutosh; Malhotra, Rakhi; Burkholder, Greer A; Mugavero, Michael J; Raper, James L; Zinski, Anne

2015-09-01

Following the release of the 2010 National HIV/AIDS Strategy for the United States, the Institute of Medicine (IOM) issued core clinical indicators for measuring health outcomes in HIV-positive persons. As early retention in HIV primary care is associated with improved long-term health outcomes, we employed IOM indicators as a guide to examine a cohort of persons initiating HIV outpatient medical care at a university-affiliated HIV clinic in the Southern United States (January 2007-July 2012). Using indicators for visit attendance, CD4 and viral load laboratory testing frequency, and antiretroviral therapy initiation, we evaluated factors associated with achieving IOM core indicators among care- and treatment-naïve patients during the first year of HIV care. Of 448 patients (mean age = 35 years, 35.7% white, 79.0% male, 58.4% education beyond high school, 35.9% monthly income > $1,000 US, 47.3% uninsured), 84.6% achieved at least four of five IOM indicators. In multivariable analyses, persons with monthly income > $1,000 (ORadj. = 3.71; 95% CI: 1.68-8.19; p = 0.001) and depressive symptoms (ORadj. = 2.13; 95% CI: 1.02-4.45; p = 0.04) were significantly more likely to achieve at least four of the five core indicators, while patients with anxiety symptoms were significantly less likely to achieve these indicators (ORadj. = 0.50; 95% CI: 0.26-0.97; p = 0.04). Age, sex, race, education, insurance status, transportation barriers, alcohol use, and HIV status disclosure to family were not associated with achieving core indicators. Evaluating and addressing financial barriers and anxiety symptoms during the first year of HIV outpatient care may improve individual health outcomes and subsequent achievement of the National HIV/AIDS Strategy.

Needs assessment for collaborative network in pediatric clinical research and education.

PubMed

Ishiguro, Akira; Sasaki, Hatoko; Yahagi, Naohisa; Kato, Hitoshi; Kure, Shigeo; Mori, Rintaro

2017-01-01

A collaborative network for pediatric research has not been fully established in Japan. To identify the network infrastructure, we conducted a survey on the support and education for clinical research currently available in children's hospitals. In November 2014, a 27-question survey was distributed to 31 hospitals belonging to the Japanese Association of Children's Hospitals and Related Institutions (JACHRI) to assess clinical research support, research education, research achievements, and their expectations. All the hospitals responded to the survey. Overall, 74.2% of hospitals had clinical research support divisions. Although all hospitals had ethics committees, <30% of the hospitals had a data manager, intellectual property management unit, biostatistician, and English-language editor. Seven hospitals had education programs for clinical research. The number of seminars and workshops for clinical research had significant correlations with the number of physicians (r = 0.927), pediatricians (r = 0.922), and clinical trial management physicians (r = 0.962). There was a significant difference in the number of clinical trials initiated by physicians between hospitals with research education programs and those without (P < 0.01). The number of education programs was significantly correlated with the number of original articles and case reports in English (r = 0.788), and the number of publications in Japanese (r = 0.648). All hospitals recognized the need for a leader to establish a collaborative network for clinical research. Important factors for creating a collaborative system for pediatric research in Japan were identified. Human resources to support clinical research are a key factor to improve clinical research education and research achievements. © 2016 Japan Pediatric Society.

Impact of database quality in knowledge-based treatment planning for prostate cancer.

PubMed

Wall, Phillip D H; Carver, Robert L; Fontenot, Jonas D

2018-03-13

This article investigates dose-volume prediction improvements in a common knowledge-based planning (KBP) method using a Pareto plan database compared with using a conventional, clinical plan database. Two plan databases were created using retrospective, anonymized data of 124 volumetric modulated arc therapy (VMAT) prostate cancer patients. The clinical plan database (CPD) contained planning data from each patient's clinically treated VMAT plan, which were manually optimized by various planners. The multicriteria optimization database (MCOD) contained Pareto-optimal plan data from VMAT plans created using a standardized multicriteria optimization protocol. Overlap volume histograms, incorporating fractional organ at risk volumes only within the treatment fields, were computed for each patient and used to match new patient anatomy to similar database patients. For each database patient, CPD and MCOD KBP predictions were generated for D 10 , D 30 , D 50 , D 65 , and D 80 of the bladder and rectum in a leave-one-out manner. Prediction achievability was evaluated through a replanning study on a subset of 31 randomly selected database patients using the best KBP predictions, regardless of plan database origin, as planning goals. MCOD predictions were significantly lower than CPD predictions for all 5 bladder dose-volumes and rectum D 50 (P = .004) and D 65 (P < .001), whereas CPD predictions for rectum D 10 (P = .005) and D 30 (P < .001) were significantly less than MCOD predictions. KBP predictions were statistically achievable in the replans for all predicted dose-volumes, excluding D 10 of bladder (P = .03) and rectum (P = .04). Compared with clinical plans, replans showed significant average reductions in D mean for bladder (7.8 Gy; P < .001) and rectum (9.4 Gy; P < .001), while maintaining statistically similar planning target volume, femoral head, and penile bulb dose. KBP dose-volume predictions derived from Pareto plans were more optimal overall than those resulting from manually optimized clinical plans, which significantly improved KBP-assisted plan quality. This work investigates how the plan quality of knowledge databases affects the performance and achievability of dose-volume predictions from a common knowledge-based planning approach for prostate cancer. Bladder and rectum dose-volume predictions derived from a database of standardized Pareto-optimal plans were compared with those derived from clinical plans manually designed by various planners. Dose-volume predictions from the Pareto plan database were significantly lower overall than those from the clinical plan database, without compromising achievability. Copyright © 2018 Elsevier Inc. All rights reserved.

Cuff filling volumes for pediatric classic laryngeal mask airways: comparison of clinical end points versus adjusted cuff pressure.

PubMed

Ghai, Babita; Sethi, Sameer; Ram, Jagat; Wig, Jyotsna

2013-02-01

Clinical end points are often used to guide inflation and adequacy of cuff seal after laryngeal mask airway placement. However, clinical end points for cuff inflation have been shown to have significantly higher intracuff pressure. The adjusted cuff pressure between 55 and 60 cm H(2)O causes significantly better seal of laryngeal mask airway. We prospectively assessed the cuff pressures generated by cuff inflation guided by clinical end points, and the actual volume of air required to achieve cuff pressures between 55 and 60 cm H(2)O for sizes 1-2.5 reusable classic laryngeal mask airway. Two hundred and three ASA I and II children undergoing elective cataract surgery requiring general anesthesia receiving laryngeal mask airway sizes 1-2.5 were recruited to this study. The laryngeal mask airway was placed using standard technique. After insertion of laryngeal mask airway, the cuff was slowly inflated until a slight outward shift of device was noted. Cuff pressures were measured using calibrated hand held Portex Cuff Inflator Pressure Gauge (Portex Limited, Hythe, Kent, UK). If the cuff pressure was >60 cm H(2)O, the cuff was deflated to achieve a cuff pressure of 55-60 cm H(2)O. The volume of air required to achieve this pressure was recorded. The volume of air required to achieve the pressure between 55 and 60 cm H(2)O in laryngeal mask airway size 1, 1.5, 2.0, and 2.5 were 2.750 ± 0.2565, 4.951 ± 0.5378, 6.927 ± 0.6328, and 10.208 ± 1.4535 ml, respectively. The difference between the initial and the final cuff volumes and pressures in all laryngeal mask airway sizes were statistically significant(P = 0.000). Lower cuff volumes are required to achieve a pressure of 60 cm H(2)O than those required if clinical end points are used as a sole guide for determining cuff inflation for patients receiving pediatric laryngeal mask airways. © 2012 Blackwell Publishing Ltd.

The population-level impacts of a national health insurance program and franchise midwife clinics on achievement of prenatal and delivery care standards in the Philippines

PubMed Central

Kozhimannil, Katy Backes; Valera, Madeleine R.; Adams, Alyce S.; Ross-Degnan, Dennis

2009-01-01

Objectives Adequate prenatal and delivery care are vital components of successful maternal health care provision. Starting in 1998, two programs were widely expanded in the Philippines: a national health insurance program (PhilHealth); and a donor-funded franchise of midwife clinics (Well-Family Midwife Clinics). This paper examines population-level impacts of these interventions on achievement of minimum standards for prenatal and delivery care. Methods Data from two waves of the Demographic and Health Surveys, conducted before (1998) and after (2003) scale up of the interventions, are employed in a pre/post study design, using longitudinal multivariate logistic and linear regression models. Results After controlling for demographic and socioeconomic characteristics, the PhilHealth insurance program scale up was associated with increased odds of receiving at least four prenatal visits (OR 1.04 [95% CI 1.01–1.06]) and receiving a visit during the first trimester of pregnancy (OR 1.03 [95% CI 1.01–1.06]). Exposure to midwife clinics was not associated with significant changes in achievement of prenatal care standards. While both programs were associated with slight increases in the odds of delivery in a health facility, these increases were not statistically significant. Conclusions These results suggest that expansion of an insurance program with accreditation standards was associated with increases in achievement of minimal standards for prenatal care among women in the Philippines. PMID:19327862

Clinical Preventive Services for Older Adults: The Interface Between Personal Health Care and Public Health Services

PubMed Central

Richards, Chesley L.; Shenson, Douglas

2012-01-01

Healthy aging must become a priority objective for both population and personal health services, and will require innovative prevention programming to span those systems. Uptake of essential clinical preventive services is currently suboptimal among adults, owing to a number of system- and office-based care barriers. To achieve maximum health results, prevention must be integrated across community and clinical settings. Many preventive services are portable, deliverable in either clinical or community settings. Capitalizing on that flexibility can improve uptake and health outcomes. Significant reductions in health disparities, mortality, and morbidity, along with decreases in health spending, are achievable through improved collaboration and synergy between population health and personal health systems. PMID:22390505

Academic achievement and primary care specialty selection of volunteers at a student-run free clinic.

PubMed

Vaikunth, Sumeet S; Cesari, Whitney A; Norwood, Kimberlee V; Satterfield, Suzanne; Shreve, Robert G; Ryan, J Patrick; Lewis, James B

2014-01-01

Previous studies have reached conflicting conclusions about the associations between service and academic achievement and service and primary care specialty choice. This study examines the associations between service at a student-run clinic and academic achievement and primary care specialty choice. Retrospective review of medical student service and statistical analysis of grade point average (GPA), Step 1 and Step 2 Clinical Knowledge (CK) scores, and specialty choice were conducted, as approved by our Institutional Review Board. Volunteers, compared to nonvolunteers, had higher GPA (3.59 ± 0.33 vs. 3.40 ± 0.39, p < .001), Step 1 (229 ± 19 vs. 220 ± 21, p < .001), and Step 2 CK (240 ± 18 vs. 230 ± 21, p < .001) scores, but did not pursue primary care specialties at a significantly higher percentage (52% vs. 51%, χ² = .051, p = .82). Further exploration of the associations between service and academic achievement and primary care specialty choice is warranted.

A comparative evaluation of 4% articaine and 2% lidocaine in mandibular buccal infiltration anesthesia: A clinical study

PubMed Central

Maruthingal, Sunith; Mohan, Dennis; Maroli, Ramesh Kumar; Alahmari, Ali; Alqahtani, Ahmed; Alsadoon, Mohammed

2015-01-01

Background: To compare 4% articaine and 2% lidocaine local anesthetics in achieving pulpal anesthesia of the lower first permanent molar teeth objectively, and to assess and compare lip and lingual mucosa numbness subjectively. Materials and Methods: All subjects received 1.7 ml of any one anesthetic in the mucobuccal fold adjacent to mandibular first molar teeth; the same individuals received the second infiltration at least 1 week after the first. Later, comparisons for pulpal anesthesia, lip and lingual mucosa numbness between these two anesthetics solutions were made. Results: Articaine showed significant results with P = 0.006 in achieving pulpal anesthesia objectively, when compared with lidocaine. Articaine also showed very high significant results subjectively with P = 0.0006 in achieving lip numbness, when compared with lidocaine. But the results in achieving lingual mucosa numbness with articaine subjectively was not significant with P = 0.01, when compared with lidocaine. Conclusion: Endodontic and operative treatments are one of the most common oral non-surgical procedures done under local anesthesia. The diversity of anesthetic substances currently available on the market requires dental professionals to assess the drug both by its pharmacokinetic and also by its clinical characteristics during dental treatments. Our study used 4% articaine, which is available in the market, for comparison with 2% lidocaine. Further studies are required to use an equal concentration of solutions to achieve more accurate results. PMID:26759799

Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

PubMed

Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

2016-07-01

The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

TESTOSTERONE LEVELS ACHIEVED BY MEDICALLY TREATED TRANSGENDER WOMEN IN A UNITED STATES ENDOCRINOLOGY CLINIC COHORT.

PubMed

Liang, Jennifer J; Jolly, Divya; Chan, Kelly J; Safer, Joshua D

2018-02-01

Most transgender women depend on medical treatment alone to lower testosterone levels in order to align physical appearance with gender identity. The medical regimen in the United States typically includes spironolactone and estrogens. The purpose of this cross-sectional study was to assess the testosterone suppression achieved among transgender women treated with spironolactone and estrogens. Testosterone and estradiol levels were extracted from the electronic medical records of 98 anonymized transgender women treated with oral spironolactone and oral estrogen therapy at the Endocrinology Clinic at Boston Medical Center. Patients starting therapy required about 9 months to reach a steady-state testosterone, with significant heterogeneity of levels achieved among patients. Patients with normal body mass index (BMI) had higher testosterone levels, whereas patients with obese BMI had lower testosterone levels throughout treatment. Stratification of patients by age or spironolactone dosage revealed no significant difference in testosterone levels achieved. At steady state, patients in the highest suppressing quartile were able to achieve testosterone levels of 27 ng/dL, with a standard deviation of 21 ng/dL. Measured serum estradiol levels did not change over time and did not correlate with dosage of estradiol administered. Among a cohort of transgender women treated with spironolactone and estrogen, the highest suppressing quartile could reliably achieve testosterone levels in the female range at virtually all times. The second highest suppressing quartile could not achieve female levels but remained below the male range virtually all of the time. One quartile was unable to achieve any significant suppression. BMC = Boston Medical Center BMI = body mass index CPY = cyproterone acetate LC-MS/MS = liquid chromatography-tandem mass spectrometry Q = quartile.

The relationship between medical students' epistemological beliefs and achievement on a clinical performance examination.

PubMed

Oh, Sun-A; Chung, Eun-Kyung; Han, Eui-Ryoung; Woo, Young-Jong; Kevin, Deiter

2016-03-01

This study was to explore the relationship between clinical performance examination (CPX) achievement and epistemological beliefs to investigate the potentials of epistemological beliefs in ill-structured medical problem solving tasks. We administered the epistemological beliefs questionnaire (EBQ) to fourth-year medical students and correlated the results with their CPX scores. The EBQ comprised 61 items reflecting five belief systems: certainty of knowledge, source of knowledge, rigidity of learning, ability to learn, and speed of knowledge acquisition. The CPX included scores for history taking, physical examination, and patient-physician interaction. The higher epistemological beliefs group obtained significantly higher scores on the CPX with regard to history taking and patient-physician interaction. The epistemological beliefs scores on certainty of knowledge and source of knowledge were significantly positively correlated with patient-physician interaction. The epistemological beliefs scores for ability to learn were significantly positively correlated with those for history taking, physical examination, and patient-physician interaction. Students with more sophisticated and advanced epistemological beliefs stances used more comprehensive and varied approaches in the patient-physician interaction. Therefore, educational efforts that encourage discussions pertaining to epistemological views should be considered to improve clinical reasoning and problem-solving competence in the clinic setting.

Student performance on levels 1 and 2-CE of COMLEX-USA: do elective upper-level undergraduate science courses matter?

PubMed

Wong, Stanley K; Ramirez, Juan R; Helf, Scott C

2009-11-01

The effect of a variety of preadmission variables, including the number of elective preadmission upper-level science courses, on academic achievement is not well established. To investigate the relationship between number of preadmission variables and overall student academic achievement in osteopathic medical school. Academic records of osteopathic medical students in the 2008 and 2009 graduating classes of Western University of Health Sciences College of Osteopathic Medicine of the Pacific in Pomona, California, were analyzed. Multivariate linear regression analyses were performed to identify predictors of academic achievement based on Medical College Admission Test (MCAT) subscores, undergraduate grade point average (GPA), GPA in medical school basic science (preclinical GPA) and clinical clerkship (clinical GPA), and scores on the Comprehensive Osteopathic Medical Licensing Examination-USA (COMLEX-USA) Level 1 and Level 2-Cognitive Evaluation (CE). Records of 358 osteopathic medical students were evaluated. Analysis of beta coefficients suggested that undergraduate science GPA was the most important predictor of overall student academic achievement (P<.01). Biological sciences MCAT subscore was a more modest but still statistically significant predictor of preclinical GPA and COMLEX-USA Level 1 score (P<.01). Physical sciences MCAT subscore was also a statistically significant predictor of preclinical GPA, and verbal reasoning MCAT subscore was a statistically significant predictor of COMLEX-USA Level 2-CE score (both P<.01). Women had statistically significantly higher preclinical GPA and COMLEX-USA Level 2-CE scores than men (P<.05). Differences in some outcome variables were also associated with racial-ethnic background and age. Number of preadmission elective upper-level science courses taken by students before matriculation was not significantly correlated with any academic achievement variable. Although undergraduate science GPA and MCAT biological sciences subscore were significant predictors of overall academic achievement for osteopathic medical students, the number of elective upper-level science courses taken preadmission had no predictive value.

Editorial Commentary: All-Inside Anterior Cruciate Ligament Reconstruction Can Afford Satisfactory Clinical Outcome and Functional Stability.

PubMed

Yoshiya, Shinichi

2016-02-01

Anatomic all-inside anterior cruciate ligament reconstruction using the autogenous semitendinosus tendon graft can afford satisfactory outcomes, achieving significant postoperative improvement in all clinical parameters. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Trough concentration and ABCG2 polymorphism are better to predict imatinib response in chronic myeloid leukemia: a meta-analysis.

PubMed

Jiang, Zhi-Ping; Zhao, Xie-Lan; Takahashi, Naoto; Angelini, Sabrina; Dubashi, Biswajit; Sun, Li; Xu, Ping

2017-01-01

The present study aimed to conduct a series of meta-analyses to investigate the influence of imatinib trough concentration (C 0 ), as well as ABCB1 and ABCG2 polymorphisms, on the clinical response in patients with chronic myeloid leukemia (CML). A literature search was conducted using the PubMed and Cochrane electronic databases to locate relevant papers from 2003 onward. Then, an initial meta-analysis of 14 studies involving 2184 patients was conducted to understand the effect of imatinib mesylate (IM) C 0 on clinical outcome in CML patients. Subsequently, a series of meta-analyses were performed, including up to 23 studies with 2577 patients, on the effect of genetic polymorphisms of ABCB1 and ABCG2 on the clinical response to IM. Meta-analysis revealed that patients who achieved a major molecular response (MMR) have a significantly higher IM C 0 than those who failed to achieve an MMR. We also found that the patients who achieved a complete cytogenic response (CCyR) have a significantly higher IM C 0 than those who did not achieve a CCyR. However, no significant difference in IM C 0 was found between the complete molecular response and non-complete molecular response groups. Additional analysis showed that ABCG2 421 variant A allele was significantly associated with a higher rate of MMR and overall response, especially in Asian patients. Meta-analysis did not reveal a correlation between ABCB1 C3435T and C1236T polymorphisms with any clinical response to IM. However, the G2677T/A polymorphism could play a role in IM response in the recessive model. This meta-analysis demonstrates that there was a significant correlation between the IM trough concentration and clinical responses, especially MMR and CCyR, in CML patients. Furthermore, we found that the probability of successful treatment was correlated with the ABCG2 C421A polymorphism, at least within the Asian population. We failed to determine an association between ABCB1 polymorphisms and IM response, although the G2677T/A polymorphism might be involved. However, further large-scale investigations using more sensitive genotyping methods would be required to confirm this.

Melanoma detection. A prospective study comparing diagnosis with the naked eye, dermatoscopy and telespectrophotometry.

PubMed

Bono, Aldo; Bartoli, Cesare; Cascinelli, Natale; Lualdi, Manuela; Maurichi, Andrea; Moglia, Daniele; Tragni, Gabrina; Tomatis, Stefano; Marchesini, Renato

2002-01-01

Successful treatment of melanoma depends directly on early diagnosis. Such a diagnosis is based on clinical examination and dermatoscopy. Recently, automated instruments for melanoma detection are under development. To prospectively evaluate the diagnostic possibilities provided by clinical and dermatoscopic examinations and by a computerized telespectrophotometric system (TS). The study involves a consecutive series of 298 patients with 313 cutaneous pigmented lesions (66 melanomas and 247 non-melanoma lesions). Each lesion was subjected to the triple diagnostic evaluation, before surgery. Results were expressed in terms of sensitivity and specificity of each kind of evaluation. Clinical evaluation had sensitivity and specificity values of 86 and 77%, respectively, whereas dermatoscopy gave corresponding values of 91 and 74%. TS assessment resulted in a sensitivity of 80% and a specificity of 49%. Differences between clinical and dermatoscopic diagnoses lacked statistical significance (p = 0.22), whereas there was a significant difference comparing both clinical and TS evaluations (p < 0.01) and dermatoscopic and TS evaluations (p < 0.01). Combining clinical and dermatoscopic evaluations, a sensitivity of 97% was achieved. Addition of TS has not changed this figure. Results of this study confirm and stress the importance of dermatoscopy in the diagnosis of melanoma. Clinical evaluation coupled with dermatoscopy can be considered the cornerstone of such a diagnosis. Although TS is able to achieve interesting results, at present it cannot significantly compete with any of the other tested methods. Copyright 2002 S. Karger AG, Basel

Recovery in patients with major depressive disorder (MDD): results of a 6-month, multinational, observational study.

PubMed

Novick, Diego; Montgomery, William; Vorstenbosch, Ellen; Moneta, Maria Victoria; Dueñas, Héctor; Haro, Josep Maria

2017-01-01

Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression.

[Clinical analysis of nasal mucosa contact headache].

PubMed

Gu, Qingjia; Wen, Bei; Li, Jingxian; Fan, Jiangang; He, Gang

2013-07-01

To investigate the efficacy of nasal mucosa contact point headache with the treatment of endoscopic sinus surgery. Clinical data of 75 cases with nasal mucosa contact point headache treated in our department from Jan 2008 to Nov 2011 were retrospectively analyzed. These patients were performed with endoscopic sinus surgery. All patients were followed up for more than six months. They all achieved significant efficacy and no complications occurred. Nasal mucosa contact point headache and primary headache had different clinical features and different treatment. Misdiagnosis were easily made if not being carefully analyzed. Three lines tension relaxing septorhinoplasty combined with nasal bone fracture correction can achieve satisfactory curative effect and can effectively prevent the occurrence of complications. Therefore, it is necessary to strengthen the awareness of this disease. Nasal structure abnormality is the main reason of nasal mucosa contact point headache. The implementation of individualized nasal endoscopic sinus surgery can achieve satisfactory curative effect.

Incentivizing primary care providers to innovate: building medical homes in the post-Katrina New Orleans safety net.

PubMed

Rittenhouse, Diane R; Schmidt, Laura A; Wu, Kevin J; Wiley, James

2014-02-01

To evaluate safety-net clinics' responses to a novel community-wide Patient-Centered Medical Home (PCMH) financial incentive program in post-Katrina New Orleans. Between June 2008 and June 2010, we studied 50 primary care clinics in New Orleans receiving federal funds to expand services and improve care delivery. Multiwave, longitudinal, observational study of a local safety-net primary care system. Clinic-level data from a semiannual survey of clinic leaders (89.3 percent response rate), augmented by administrative records. Overall, 62 percent of the clinics responded to financial incentives by achieving PCMH recognition from the National Committee on Quality Assurance (NCQA). Higher patient volume, higher baseline PCMH scores, and type of ownership were significant predictors of achieving NCQA recognition. The steepest increase in adoption of PCMH processes occurred among clinics achieving the highest, Level 3, NCQA recognition. Following NCQA recognition, 88.9 percent stabilized or increased their use of PCMH processes, although several specific PCMH processes had very low rates of adoption overall. Findings demonstrate that widespread PCMH implementation is possible in a safety-net environment when external financial incentives are aligned with the goal of practice innovation. © Health Research and Educational Trust.

A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.

PubMed

Cheng, Steven K; Dietrich, Mary S; Dilts, David M

2010-11-15

Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period (n = 419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), controlling for study phase and size of expected accruals. Among the CTEP-approved oncology trials, 37.9% (n = 221) failed to attain the minimum accrual goals, with 70.8% (n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients (42.5% of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development times of 12 to 18 months. Trials requiring a development time of greater than 24 months were significantly less likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than trials with the median development time. A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. ©2010 AACR.

Pre-admission criteria and pre-clinical achievement: Can they predict medical students performance in the clinical phase?

PubMed

Salem, Raneem O; Al-Mously, Najwa; AlFadil, Sara; Baalash, Amal

2016-01-01

Various factors affect medical students' performance during clinical phase. Identifying these factors would help in mentoring weak students and help in selection process for residency programmes. Our study objective is to evaluate the impact of pre-admission criteria, and pre-clinical grade point average (GPA) on undergraduate medical students' performance during clinical phase. This study has a cross-sectional design that includes fifth- and sixth-year female medical students (71). Data of clinical and pre-clinical GPA in medical school and pre-admission to medical school tests scores were collected. A significant correlation between clinical GPA with the pre-clinical GPA was observed (p < 0.05). Such significant correlation was not seen with other variables under study. A regression analysis was performed, and the only significant predictor of students clinical performance was the pre-clinical GPA (p < 0.001). However, no significant difference between students' clinical and pre-clinical GPA for both cohorts was observed (p > 0.05). Pre-clinical GPA is strongly correlated with and can predict medical students' performance during clinical years. Our study highlighted the importance of evaluating the academic performances of students in pre-clinical years before they move into clinical years in order to identify weak students to mentor them and monitor their progress.

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.

Structural and incremental validity of the Wechsler Adult Intelligence Scale-Fourth Edition with a clinical sample.

PubMed

Nelson, Jason M; Canivez, Gary L; Watkins, Marley W

2013-06-01

Structural and incremental validity of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV; Wechsler, 2008a) was examined with a sample of 300 individuals referred for evaluation at a university-based clinic. Confirmatory factor analysis indicated that the WAIS-IV structure was best represented by 4 first-order factors as well as a general intelligence factor in a direct hierarchical model. The general intelligence factor accounted for the most common and total variance among the subtests. Incremental validity analyses indicated that the Full Scale IQ (FSIQ) generally accounted for medium to large portions of academic achievement variance. For all measures of academic achievement, the first-order factors combined accounted for significant achievement variance beyond that accounted for by the FSIQ, but individual factor index scores contributed trivial amounts of achievement variance. Implications for interpreting WAIS-IV results are discussed. (PsycINFO Database Record (c) 2013 APA, all rights reserved).

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

Niclosamide as an adjuvant to etanercept in treatment patients with active rheumatoid arthritis: an 8-week randomized controlled pilot study.

PubMed

Al-Gareeb, Ali Ismail A; Gorial, Faiq Isho; Mahmood, Ahmed S

2018-06-07

This study designed to identify the therapeutic efficacy of niclosamide (NCL) in Iraqi patients suffering from active rheumatoid arthritis (RA) who were using etanercept (ETN) for more than 3 months and still had high or moderate active RA. One hundred ten patients suffering from active rheumatoid arthritis (RA) who were using etanercept (ETN) for more than 3 months and still had high or moderate active RA were allocated randomly into two equal groups: one of them treated with 1000 mg/day NCL and the other treated with 1000 mg/day lactose in capsule dosage form. The study duration was 8 weeks. Clinical efficacy of the NCL was measured depending on scoring of the 28-joint Disease Activity Score (DAS28), simple disease activity index (SDAI), clinical disease activity index (CDAI), and Health Assessment Questionnaire Disability Index (HAQ-DI) at the baseline and at the end of the 8-week treatment period. Moreover, blood sample were taken from the patients at baseline and at after 8 weeks of treatment for measurement of the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin 1β (IL-1 β), interleukin-6, tumor necrosis factor (TNF-α), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and E-selectin. At the end of the clinical study, patients had good response to NCL when added to the ETN with a high significant improvement in the SJC, TJC, DAS-28, CDAI, SDAI, and HAQ-DI compared to patients who were received placebo drug. In addition to that, 33% of patients achieved an ACR 20% response (ACR20) on NCL and ETN. Of these, 4% achieved ACR50 and another 4% achieved ACR70 response. While those group treated by placebo + ETN, 5% achieved ACR20 response and no one reached to ACR50 or ACR70 response. Twenty-seven percent of RA patients who have taken the NCL achieved moderate EULAR score while only 17% from the group that taken placebo with ETN achieved moderate response. On the other hand, no significant reduction was found in CRP, ESR, TNF-α, and IL-6, while IL-1 β reduced significantly after treatment with NCL. Treatment with NCL also exerts a significant lowering in the serum level of the E-selectin, ICAM1, and VCAM1 when compared to their value in baseline level. In RA disease, the use of NCL as adjuvant with ETN has resulted in a marked reduction in clinical assessment scoring indices and significantly decreased the E-selectin, ICAM-1, and VCAM-1 with marked improvement in the quality of life of patients.

Recovery in patients with major depressive disorder (MDD): results of a 6-month, multinational, observational study

PubMed Central

Novick, Diego; Montgomery, William; Vorstenbosch, Ellen; Moneta, Maria Victoria; Dueñas, Héctor; Haro, Josep Maria

2017-01-01

Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression. PMID:29184393

In vitro manipulation of mammalian gametes and embryos: what are we learning from animal settings

USDA-ARS?s Scientific Manuscript database

Since the birth of the first baby conceived by in vitro fertilization (Louise Brown) in 1978, significant progress has been achieved in the application of assisted reproductive technology (ART) in clinical settings. A significant accumulation of knowledge obtained through various research endeavors ...

Comparative efficacy of golimumab, infliximab, and adalimumab for moderately to severely active ulcerative colitis: a network meta-analysis accounting for differences in trial designs.

PubMed

Thorlund, Kristian; Druyts, Eric; Toor, Kabirraaj; Mills, Edward J

2015-05-01

To conduct a network meta-analysis (NMA) to establish the comparative efficacy of infliximab, adalimumab and golimumab for the treatment of moderately to severely active ulcerative colitis (UC). A systematic literature search identified five randomized controlled trials for inclusion in the NMA. One trial assessed golimumab, two assessed infliximab and two assessed adalimumab. Outcomes included clinical response, clinical remission, mucosal healing, sustained clinical response and sustained clinical remission. Innovative methods were used to allow inclusion of the golimumab trial data given the alternative design of this trial (i.e., two-stage re-randomization). After induction, no statistically significant differences were found between golimumab and adalimumab or between golimumab and infliximab. Infliximab was statistically superior to adalimumab after induction for all outcomes and treatment ranking suggested infliximab as the superior treatment for induction. Golimumab and infliximab were associated with similar efficacy for achieving maintained clinical remission and sustained clinical remission, whereas adalimumab was not significantly better than placebo for sustained clinical remission. Golimumab and infliximab were also associated with similar efficacy for achieving maintained clinical response, sustained clinical response and mucosal healing. Finally, golimumab 50 and 100 mg was statistically superior to adalimumab for clinical response and sustained clinical response, and golimumab 100 mg was also statistically superior to adalimumab for mucosal healing. The results of our NMA suggest that infliximab was statistically superior to adalimumab after induction, and that golimumab was statistically superior to adalimumab for sustained outcomes. Golimumab and infliximab appeared comparable in efficacy.

Stent Retriever Thrombectomy in Different Thrombus Locations of Anterior Cerebral Circulation

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

Protto, Sara; Sillanpää, Niko, E-mail: niko.sillanpaa@pshp.fi; Pienimäki, Juha-Pekka

BackgroundMechanical thrombectomy (MT) is a safe and efficient treatment for acute ischemic stroke in patients with proximal anterior occlusion and large penumbra. We evaluated the technical and clinical success of MT in relation to the location of the occlusion (internal carotid artery, M1 and M2 segments of the middle cerebral artery).MethodsWe prospectively reviewed 130 patients of whom 105 met the inclusion criteria. Baseline clinical, procedural and imaging variables, technical outcome (TICI, thrombolysis in cerebral infarction), 24 h imaging outcome and three-month clinical outcome (mRS, modified Rankin Scale) were recorded. Differences between the groups were studied with statistical tests according to themore » type of the variable.ResultsThere were 37, 46 and 22 patients in the internal carotid artery (ICA), M1 and M2 groups, respectively. TICI 2b or 3 was achieved in 92 cases (88 %) with a non-significant trend towards a better recanalization outcome in the ICA and M1 groups. Overall, 57 of the 105 patients (55 %) experienced favorable clinical outcome (mRS ≤ 2) with no significant differences between the groups. Excellent outcome (mRS ≤ 1) was seen in 40 patients (39 %) and there proportionally more patients with excellent outcome in the ICA and M1 groups (ICA: 44 %, M1: 41 %, M2: 23 % of patients, p = 0.22).ConclusionsThere were no statistically significant differences in the technical or clinical outcomes between the different sites of occlusion (ICA, M1 or M2). There was a non-significant trend towards achieving excellent clinical outcome (3-month mRS ≤ 1) more often and better recanalization results in the two more proximal locations.« less

Delta-9-tetrahydrocannabinol/cannabidiol (Sativex®): a review of its use in patients with moderate to severe spasticity due to multiple sclerosis.

PubMed

Syed, Yahiya Y; McKeage, Kate; Scott, Lesley J

2014-04-01

Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) [Sativex®] is an oromucosal spray formulation that contains principally THC and CBD at an approximately 1:1 fixed ratio, derived from cloned Cannabis sativa L. plants. The main active substance, THC, acts as a partial agonist at human cannabinoid receptors (CB1 and CB2), and thus, may modulate the effects of excitatory (glutamate) and inhibitory (gamma-aminobutyric acid) neurotransmitters. THC/CBD is approved in a number of countries, including Germany and the UK, as an add-on treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. In the largest multinational clinical trial that evaluated the approved THC/CBD regimen in this population, 12 weeks' double-blind treatment with THC/CBD significantly reduced spasticity severity (primary endpoint) compared with placebo in patients who achieved a clinically significant improvement in spasticity after 4 weeks' single-blind THC/CBD treatment, as assessed by a patient-rated numerical rating scale. A significantly greater proportion of THC/CBD than placebo recipients achieved a ≥ 30% reduction (a clinically relevant reduction) in spasticity severity. The efficacy of THC/CBD has been also shown in at least one everyday clinical practice study (MOVE 2). THC/CBD was generally well tolerated in clinical trials. Dizziness and fatigue were reported most frequently during the first 4 weeks of treatment and resolved within a few days even with continued treatment. Thus, add-on THC/CBD is a useful symptomatic treatment option for its approved indication.

Evaluation of lorcaserin for the treatment of obesity.

PubMed

Berlie, Helen D; Hurren, Kathryn M

2013-08-01

Obesity is an epidemic associated with significant morbidity. Lorcaserin , a novel serotonin 2C receptor antagonist, was recently approved as an adjunct to lifestyle modification for long-term weight loss and maintenance. Clinical studies in patients without diabetes demonstrated 5.8% mean weight loss from baseline with lorcaserin compared to 2.5% with placebo and over twice as many patients achieved ≥ 5% weight loss. Patients with diabetes achieved mean weight loss of 4.5% with lorcaserin compared to 1.5% with placebo as well as modest improvements in glycemic outcomes. The authors review the pharmacology and clinical efficacy as well as the safety and tolerability of lorcaserin. This was achieved through a PubMed search (1960 - present) on lorcaserin to generate the key literature in the area. The lorcaserin package insert and Food and Drug Administration briefing documents were also used to identify relevant information. To assess long-term clinical efficacy and safety, the authors used studies with a minimum duration of one year. Lorcaserin induces moderate but significant weight loss compared to placebo as an adjunct to lifestyle modification. Although head-to-head comparison trials are not available, lorcaserin is likely less effective but better tolerated than its recently approved competitor, phentermine/topiramate. Cardiovascular outcome data will be invaluable in determining lorcaserin's eventual utilization and place in therapy.

First Pass Effect: A New Measure for Stroke Thrombectomy Devices.

PubMed

Zaidat, Osama O; Castonguay, Alicia C; Linfante, Italo; Gupta, Rishi; Martin, Coleman O; Holloway, William E; Mueller-Kronast, Nils; English, Joey D; Dabus, Guilherme; Malisch, Tim W; Marden, Franklin A; Bozorgchami, Hormozd; Xavier, Andrew; Rai, Ansaar T; Froehler, Michael T; Badruddin, Aamir; Nguyen, Thanh N; Taqi, M Asif; Abraham, Michael G; Yoo, Albert J; Janardhan, Vallabh; Shaltoni, Hashem; Novakovic, Roberta; Abou-Chebl, Alex; Chen, Peng R; Britz, Gavin W; Sun, Chung-Huan J; Bansal, Vibhav; Kaushal, Ritesh; Nanda, Ashish; Nogueira, Raul G

2018-03-01

In acute ischemic stroke, fast and complete recanalization of the occluded vessel is associated with improved outcomes. We describe a novel measure for newer generation devices: the first pass effect (FPE). FPE is defined as achieving a complete recanalization with a single thrombectomy device pass. The North American Solitaire Acute Stroke Registry database was used to identify a FPE subgroup. Their baseline features and clinical outcomes were compared with non-FPE patients. Clinical outcome measures included 90-days modified Rankin Scale score, National Institutes of Health Stroke Scale score, mortality, and symptomatic intracranial hemorrhage. Multivariate analyses were performed to determine whether FPE independently resulted in improved outcomes and to identify predictors of FPE. A total of 354 acute ischemic stroke patients underwent thrombectomy in the North American Solitaire Acute Stroke registry. FPE was achieved in 89 out of 354 (25.1%). More middle cerebral artery occlusions (64% versus 52.5%) and fewer internal carotid artery occlusions (10.1% versus 27.7%) were present in the FPE group. Balloon guide catheters were used more frequently with FPE (64.0% versus 34.7%). Median time to revascularization was significantly faster in the FPE group (median 34 versus 60 minutes; P =0.0003). FPE was an independent predictor of good clinical outcome (modified Rankin Scale score ≤2 was seen in 61.3% in FPE versus 35.3% in non-FPE cohort; P =0.013; odds ratio, 1.7; 95% confidence interval, 1.1-2.7). The independent predictors of achieving FPE were use of balloon guide catheters and non-internal carotid artery terminus occlusion. The achievement of complete revascularization from a single Solitaire thrombectomy device pass (FPE) is associated with significantly higher rates of good clinical outcome. The FPE is more frequently associated with the use of balloon guide catheters and less likely to be achieved with internal carotid artery terminus occlusion. © 2018 American Heart Association, Inc.

Unilobar Versus Bilobar Biliary Drainage: Effect on Quality of Life and Bilirubin Level Reduction

PubMed Central

Gamanagatti, Shivanand; Singh, Tejbir; Sharma, Raju; Srivastava, Deep N; Dash, Nihar Ranjan; Garg, Pramod Kumar

2016-01-01

Background: Percutaneous biliary drainage is an accepted palliative treatment for malignant biliary obstruction. Purpose: To assess the effect on quality of life (QOL) and bilirubin level reduction in patients with inoperable malignant biliary obstruction treated by unilobar or bilobar percutaneous transhepatic biliary drainage (PTBD). Materials and Methods: Over a period of 2 years, 49 patients (age range, 22–75 years) of inoperable malignant biliary obstruction were treated by PTBD. Technical and clinical success rates, QOL, patency rates, survival rates, and complications were recorded. Clinical success rates, QOL, and bilirubin reduction were compared in patients treated with complete (n = 21) versus partial (n = 28) liver parenchyma drainage. QOL before and 1 month after biliary drainage were analyzed retrospectively between these two groups. Results: Biliary drainage was successful in all 49 patients, with an overall significant reduction of the postintervention bilirubin levels (P < 0.001) resulting in overall clinical success rate of 89.97%. Clinical success rates were similar in patients treated with whole-liver drainage versus partial-liver drainage. Mean serum bilirubin level before PTBD was 19.85 mg/dl and after the procedure at 1 month was 6.02 mg/dl. The mean baseline functional score was 39.35, symptom scale score was 59.55, and global health score was 27.45. At 1 month, mean functional score was 61.25, symptom scale score was 36.0 4, and global health score was 56.33, with overall significant improvement in QOL (<0.001). There was a statistically significant difference in the improvement of the QOL scores (P = 0.002), among patients who achieved clinical success, compared with those patients who did not achieve clinical success at 1 month. We did not find any significant difference in the QOL scores in patients according to the amount of liver drained (unilateral or bilateral drainage), the type of internalization used (ring biliary or stent). Overall, minor and major complications rates were 14.3% and 8.1%, respectively. Conclusion: Percutaneous biliary drainage provides good palliation of malignant obstructive jaundice. Partial-liver drainage achieved results as good as those after complete liver drainage with significant improvements in QOL and reduction of the bilirubin level. PMID:26962281

The effect of a multidisciplinary care clinic on the outcomes in pediatric chronic kidney disease.

PubMed

Ajarmeh, Salma; Er, Lee; Brin, Genevieve; Djurdjev, Ognjenka; Dionne, Janis M

2012-10-01

Current best evidence-based practice for children with chronic kidney disease (CKD) attempts to achieve good clinical outcomes through careful management of comorbidities and is likely best achieved with a multidisciplinary care (MDC) CKD clinic. In this retrospective study of children with CKD in British Columbia, Canada, we analyzed clinical outcomes in a cohort of 73 CKD patients from 2003 under a standard care model and a second cohort of 125 CKD patients from 2009 under a MDC clinic model. Patient demographics were similar, but there was a decrease in the percentage of patients with CKD stage 3-5 in 2009 (59 vs. 75 %; p = 0.002), although the absolute number increased. After adjustment for severity of CKD, hemoglobin was significantly higher (13.0 g/dl vs. 12.2 g/dl, p < 0.03), calcium was significantly higher (9.6 mg/dl vs. 9.1 mg/dl, p < 0.001), and albumin was significantly higher (4.4 g/dl vs. 3.8 g/dl, p < 0.001) in the 2009 MDC cohort. The rate of disease progression, assessed by annualized estimated glomerular filtration rate (eGFR) slope, improved from -4.0 ml/min/1.73 m(2) in the 2003 cohort to 0.5 ml/min/1.73 m(2) in the 2009 cohort (p < 0.01). Blood pressure control was better in 2009 although not statistically significant. Multidisciplinary care improved the outcomes of children with CKD especially in anemia management, bone mineral metabolism, nutrition, and renal disease progression.

Effective Treatment of Advanced Human Melanoma Metastasis in Immunodeficient Mice Using Combination Metronomic Chemotherapy Regimens

PubMed Central

Cruz-Munoz, William; Man, Shan; Kerbel, Robert S.

2009-01-01

Statement of translational relevance Despite significant efforts over the last two decades aimed at improving the efficacy of standard treatment (maximum tolerated dose (MTD) of dacarbazine), there has been no significant increase in the median survival of patients suffering from metastatic melanoma. Given the lack of success achieved, a rethinking of alternative treatment strategies is needed. Using preclinical models of advanced melanoma metastasis, we show that metronomic chemotherapeutic combinations results in improved survival, which is achieved with minimal toxicity. These results compare favorably with minimal effectiveness achieved by MTD dacarbazine therapy (alone or in combination with other chemotherapeutic agents or a VEGFR-blocking antibody), often accompanied by higher toxicity. Successes in preclinical setting of metastatic breast cancer have led to a clinical trial to examine the efficacy of metronomic therapy. A similar extension of the metronomic chemotherapeutic combinations presented here into the clinical setting of melanoma metastasis may be warranted. Purpose The development of effective therapeutic approaches for treatment of metastatic melanoma remains an immense challenge. Present therapies offer minimal benefit. While dacarbazine (DTIC) chemotherapy remains the standard therapy, it mediates only low response rates, usually of short duration, even when combined with other chemotherapeutic agents. Thus, new therapeutic strategies are urgently needed. Experimental design Using a newly developed preclinical model, we evaluated the efficacy of various doublet metronomic combination chemotherapy against established, advanced melanoma metastasis and compared these to the standard maximum tolerated dose (MTD) DTIC (alone or in combination with chemotherapeutic agents or VEGFR-blocking antibody) Results Whereas MTD DTIC therapy did not cause significant improvement in median survival, a doublet combination of low-dose metronomic (LDM) vinblastine (Vbl) and LDM cyclophosphamide (CTX) induced a significant increase in survival with only minimal toxicity. Furthermore, we show that the incorporation of the LDM Vbl/LDM CTX combination with a LDM DTIC regimen also results in a significant increase in survival, but not when combined with MTD DTIC therapy. We also show that a combination of metronomic Vbl therapy and a VEGFR2-blocking antibody (DC101) results in significant control of metastatic disease and that the combination of LDM Vbl/DC101 and LDM DTIC induced a significant improvement in median survival. Conclusions The effective control of advanced metastatic melanoma achieved by these metronomic-based chemotherapeutic approaches warrants clinical consideration of this treatment concept given the recent results of a number of metronomic-based chemotherapy clinical trials. PMID:19622578

Monitoring Doppler patterns and clinical parameters may predict feeding tolerance in intrauterine growth-restricted infants.

PubMed

Bozzetti, Valentina; Paterlini, Giuseppe; Gazzolo, Diego; Van Bel, Frank; Visser, Gerard H A; Roncaglia, Nadia; Tagliabue, Paolo E

2013-11-01

To detect predictors of feeding tolerance in intrauterine growth restriction (IUGR) infants with or without brain-sparing effect (BS). We conducted a case-control study in 70 IUGR infants (35 IUGR with BS, matched for gestational age with 35 IUGR infants with no BS). BS was classified as pulsatility index (PI) ratio [umbilical artery (UAPI) to middle cerebral artery (MCAPI) (U/C ratio)] > 1. Clinical parameters of feeding tolerance - days to achieve full enteral feeding (FEF) - were compared between the IUGR with BS and IUGR without BS infants. Age at the start of minimal enteral feeding (MEF) was analysed. Achievement of FEF was significantly shorter in IUGR infants without BS than in IUGR with BS. IUGR with BS started MEF later than IUGR without BS infants. Significant correlation of MEF and FEF with UA PI, U/C ratio and CRIB score was found. Multiple linear regression analysis showed significant correlations with CRIB score and caffeine administration (MEF only), and sepsis (FEF only) and U/C ratio (for both). Impaired gut function can be early detected by monitoring Doppler patterns and clinical parameters. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Effect of delayed-release dimethyl fumarate on no evidence of disease activity in relapsing-remitting multiple sclerosis: integrated analysis of the phase III DEFINE and CONFIRM studies.

PubMed

Havrdova, E; Giovannoni, G; Gold, R; Fox, R J; Kappos, L; Phillips, J Theodore; Okwuokenye, M; Marantz, J L

2017-05-01

Significant effects on clinical/neuroradiological disease activity have been reported in patients with relapsing-remitting multiple sclerosis treated with delayed-release dimethyl fumarate (DMF) in phase III DEFINE/CONFIRM trials. We conducted a post hoc analysis of integrated data from DEFINE/CONFIRM to evaluate the effect of DMF on achieving no evidence of disease activity (NEDA) in patients with relapsing-remitting multiple sclerosis. The analysis included patients randomized to DMF 240 mg twice daily, placebo or glatiramer acetate (CONFIRM only) for ≤2 years. A time-to-event method was used to estimate the percentage of patients achieving NEDA. Clinical NEDA (no relapses/no 12-week confirmed disability progression) was analysed in the intention-to-treat (ITT) population. Neuroradiological (no new/newly enlarging T2 hyperintense lesions/no gadolinium-enhancing lesions) and overall NEDA (clinical and neuroradiological NEDA) were analysed in the magnetic resonance imaging (MRI) cohort. The ITT and MRI populations comprised 1540 and 692 patients, respectively. The percentage of patients with clinical NEDA (ITT population) and neuroradiological NEDA (MRI cohort) was higher with DMF versus placebo over 2 years [clinical NEDA: 38.9% relative reduction; hazard ratio (HR), 0.61; 95% confidence interval (CI), 0.52-0.72; P < 0.0001; neuroradiological NEDA: 40.0% relative reduction; HR, 0.60; 95% CI, 0.49-0.73; P < 0.0001]. The percentage of patients achieving overall NEDA (MRI cohort) was also higher with DMF (26%) versus placebo (12%) over 2 years, with a relative risk reduction of 42.7% (HR, 0.57; 95% CI, 0.48-0.69; P < 0.0001). A significantly higher percentage of patients treated with DMF achieved NEDA status over 2 years compared with placebo. © 2017 Biogen. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

Controlled release nifedipine and valsartan combination therapy in patients with essential hypertension: the adalat CR and valsartan cost-effectiveness combination (ADVANCE-combi) study.

PubMed

Saito, Ikuo; Saruta, Takao

2006-10-01

This study was designed to compare the clinical efficacy of two calcium channel blocker-based combination therapies with an angiotensin receptor blocker in Japanese patients with essential hypertension. A 16-week, double-blind, parallel-arm, randomized clinical trial was performed to compare the efficacy and safety of the combination therapy of controlled release nifedipine (nifedipine CR) plus valsartan vs. that of amlodipine plus valsartan. The primary endpoint was the target blood pressure achievement rate. Eligible patients were randomly allocated to nifedipine CR-based or amlodipine-based treatment groups. Patients were examined every 4 weeks to determine whether the blood pressure had reached the target level. When the target level was not achieved, the drug regimen was changed; when the target blood pressure was achieved, the same study medication was continued. A total of 505 patients were enrolled in the study (nifedipine CR group: 245 cases; amlodipine group: 260 cases). After 16 weeks of treatment, blood pressure was significantly reduced in both groups, but to a larger extent in the nifedipine CR group than in the amlodipine group (p < 0.01). The target blood pressure achievement rate was also significantly higher in the nifedipine CR group (p < 0.001). There was no significant difference in the incidence of drug-related adverse events between the groups. These results indicate that the nifedipine CR-based combination therapy was superior to the amlodipine-based therapy for decreasing blood pressure and achieving the target blood pressure in patients with essential hypertension.

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

Gingival Retraction Methods: A Systematic Review.

PubMed

Tabassum, Sadia; Adnan, Samira; Khan, Farhan Raza

2017-12-01

The aim of this systematic review was to assess the gingival retraction methods in terms of the amount of gingival retraction achieved and changes observed in various clinical parameters: gingival index (GI), plaque index (PI), probing depth (PD), and attachment loss (AL). Data sources included three major databases, PubMed, CINAHL plus (Ebsco), and Cochrane, along with hand search. Search was made using the key terms in different permutations of gingival retraction* AND displacement method* OR technique* OR agents OR material* OR medicament*. The initial search results yielded 145 articles which were narrowed down to 10 articles using a strict eligibility criteria of including clinical trials or experimental studies on gingival retraction methods with the amount of tooth structure gained and assessment of clinical parameters as the outcomes conducted on human permanent teeth only. Gingival retraction was measured in 6/10 studies whereas the clinical parameters were assessed in 5/10 studies. The total number of teeth assessed in the 10 included studies was 400. The most common method used for gingival retraction was chemomechanical. The results were heterogeneous with regards to the outcome variables. No method seemed to be significantly superior to the other in terms of gingival retraction achieved. Clinical parameters were not significantly affected by the gingival retraction method. © 2016 by the American College of Prosthodontists.

Gut Microbiome Function Predicts Response to Anti-integrin Biologic Therapy in Inflammatory Bowel Diseases.

PubMed

Ananthakrishnan, Ashwin N; Luo, Chengwei; Yajnik, Vijay; Khalili, Hamed; Garber, John J; Stevens, Betsy W; Cleland, Thomas; Xavier, Ramnik J

2017-05-10

The gut microbiome plays a central role in inflammatory bowel diseases (IBDs) pathogenesis and propagation. To determine whether the gut microbiome may predict responses to IBD therapy, we conducted a prospective study with Crohn's disease (CD) or ulcerative colitis (UC) patients initiating anti-integrin therapy (vedolizumab). Disease activity and stool metagenomes at baseline, and weeks 14, 30, and 54 after therapy initiation were assessed. Community α-diversity was significantly higher, and Roseburia inulinivorans and a Burkholderiales species were more abundant at baseline among CD patients achieving week 14 remission. Several significant associations were identified with microbial function; 13 pathways including branched chain amino acid synthesis were significantly enriched in baseline samples from CD patients achieving remission. A neural network algorithm, vedoNet, incorporating microbiome and clinical data, provided highest classifying power for clinical remission. We hypothesize that the trajectory of early microbiome changes may be a marker of response to IBD treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed Central

2013-01-01

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

Epilepsy Characteristics and Clinical Outcome in Patients With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-Like Episodes (MELAS).

PubMed

Lee, Ha Neul; Eom, Soyong; Kim, Se Hoon; Kang, Hoon-Chul; Lee, Joon Soo; Kim, Heung Dong; Lee, Young-Mock

2016-11-01

Epileptic seizures in patients with mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) are heterogeneous with no pathognomonic features. We reviewed epilepsy characteristics and clinical outcome exclusively in a pediatric population. Twenty-two children and adolescents (13 males) with confirmed mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes due to mitochondrial DNA A3243G mutation and epilepsy were recruited. Clinical data including seizure semiology, treatment response, neuroimaging findings, and electroencephalography were analyzed. We also examined the effect of the age at seizure onset and initial symptoms on the clinical variables. Seizure semiology and electroencephalography abnormalities showed no syndrome-specific findings. Focal seizures occurred in 21 of 22 subjects (95.5%), whereas generalized seizures developed in seven of 22 subjects (31.8%). Twenty of 22 subjects (90.9%) achieved partial to complete reduction of clinical seizures for more than one year with a combination of more than two antiepileptic drugs. The subgroup with earlier seizure onset presented significantly earlier and showed significantly higher rates of drug-resistant epilepsy compared with the late onset group, although there were no significant differences in the initial symptoms. The subjects with severe epileptic conditions tended to have more severe clinical dysfunction and more severe organ involvement. Both focal and generalized seizures occurred in patients with MELAS. Epilepsy in this population is drug resistant, but a certain degree of clinical seizure reduction was achievable with antiepileptic drugs, with more favorable outcomes than historically expected. Close observation and active epilepsy treatment of individuals with MELAS episodes and earlier seizure onset might improve the prognosis. Copyright © 2016 Elsevier Inc. All rights reserved.

Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis.

PubMed

George, Michael D; Østergaard, Mikkel; Conaghan, Philip G; Emery, Paul; Baker, Daniel G; Baker, Joshua F

2017-10-01

Obesity has been proposed as a risk factor for refractory rheumatoid arthritis (RA). We evaluated the impact of obesity on achieving clinical and imaging definitions of low disease activity. This study evaluated 470 patients with RA from GO-BEFORE and GO-FORWARD randomised clinical trials. Included patients had blinded clinical disease activity measures and MRI at baseline, 24 and 52 weeks. Synovitis, osteitis and total inflammation scores were determined using the RA MRI scoring system. Multivariable logistic regression analyses compared odds of achieving Disease Activity Score using 28 joints and C-reactive protein (DAS28-CRP) remission, low component measures, or low MRI inflammation measures at 24 weeks in patients with obesity versus no obesity. At 24 weeks, patients with obesity were significantly less likely to achieve DAS28(CRP) remission (OR 0.47; 95% CI 0.24 to 0.92, p=0.03). In contrast, patients with obesity had similar odds of achieving low synovitis (OR 0.94; 95% CI 0.51 to 1.72, p=0.84) and inflammation scores (OR 1.16; 95% CI 0.61 to 2.22, p=0.64) and greater odds of achieving low osteitis scores (OR 2.06; 95% CI 1.10 to 3.84, p=0.02) versus normal weight patients. Patients with RA and obesity have lower rates of DAS28 remission but similar rates of low MRI activity compared with patients without obesity, suggesting that obesity and its associated comorbidities can bias clinical disease activity measures. NCT00361335 and NCT00264550; Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Treatment of attention deficit hyperactivity disorder with monoamine amino acid precursors and organic cation transporter assay interpretation

PubMed Central

Hinz, Marty; Stein, Alvin; Neff, Robert; Weinberg, Robert; Uncini, Thomas

2011-01-01

Background This paper documents a retrospective pilot study of a novel approach for treating attention deficit hyperactivity disorder (ADHD) with amino acid precursors of serotonin and dopamine in conjunction with urinary monoamine assays subjected to organic cation transporter (OCT) functional status determination. The goal of this research was to document the findings and related considerations of a retrospective chart review study designed to identify issues and areas of concern that will define parameters for a prospective controlled study. Methods This study included 85 patients, aged 4–18 years, who were treated with a novel amino acid precursor protocol. Their clinical course during the first 8–10 weeks of treatment was analyzed retrospectively. The study team consisted of PhD clinical psychologists, individuals compiling clinical data from records, and a statistician. The patients had been treated with a predefined protocol for administering amino acid precursors of serotonin and dopamine, along with OCT assay interpretation as indicated. Results In total, 67% of participants achieved significant improvement with only amino acid precursors of serotonin and dopamine. In patients who achieved no significant relief of symptoms with only amino acid precursors, OCT assay interpretation was utilized. In this subgroup, 30.3% achieved significant relief following two or three urine assays and dosage changes as recommended by the assay results. The total percentage of patients showing significant improvement was 77%. Conclusion The efficacy of this novel protocol appears superior to some ADHD prescription drugs, and therefore indicates a need for further studies to verify this observation. The findings of this study justify initiation of further prospective controlled studies in order to evaluate more formally the observed benefits of this novel approach in the treatment of ADHD. PMID:21326653

Wedge-shaped microfluidic chip for circulating tumor cells isolation and its clinical significance in gastric cancer.

PubMed

Yang, Chaogang; Zhang, Nangang; Wang, Shuyi; Shi, Dongdong; Zhang, Chunxiao; Liu, Kan; Xiong, Bin

2018-05-23

Circulating tumor cells (CTCs) have great potential in both basic research and clinical application for the managements of cancer. However, the complicated fabrication processes and expensive materials of the existing CTCs isolation devices, to a large extent, limit their clinical translation and CTCs' clinical value. Therefore, it remains to be urgently needed to develop a new platform for achieving CTCs detection with low-cost, mass-producible but high performance. In the present study, we introduced a novel wedge-shaped microfluidic chip (named CTC-ΔChip) fabricated by two pieces of glass through wet etching and thermal bonding technique for CTCs isolation, which achieved CTCs enrichment by different size without cell surface expression markers and CTCs identification with three-color immunocytochemistry method (CK+/CD45-/Nucleus+). We validated the feasibility of CTC-ΔChip for detecting CTCs from different types of solid tumor. Furthermore, we applied the newly-developed platform to investigate the clinical significance of CTCs in gastric cancer (GC). Based on "label-free" characteristic, the capture efficiency of CTC-ΔChip can be as high as 93.7 ± 3.2% in DMEM and 91.0 ± 3.0% in whole blood sample under optimized conditions. Clinically, CTC-ΔChip exhibited the feasibility of detecting CTCs from different types of solid tumor, and it identified 7.30 ± 7.29 CTCs from 2 mL peripheral blood with a positive rate of 75% (30/40) in GC patients. Interestingly, we found that GC CTCs count was significantly correlated with multiple systemic inflammation indexes, including the lymphocyte count, platelet count, the level of neutrophil to lymphocyte ratio and platelet to lymphocyte ratio. In addition, we also found that both the positivity rate and CTCs count were significantly associated with multiple clinicopathology parameters. Our novel CTC-ΔChip shows high performance for detecting CTCs from less volume of blood samples of cancer patients and important clinical significance in GC. Owing to the advantages of low-cost and mass-producible, CTC-ΔChip holds great potential of clinical application for cancer therapeutic guidance and prognostic monitoring in the future.

Women are less likely than men to achieve optimal glycemic control after 1 year of treatment: A multi-level analysis of a Korean primary care cohort.

PubMed

Choe, Seung-Ah; Kim, Joo Yeong; Ro, Young Sun; Cho, Sung-Il

2018-01-01

We investigated differences in the achievement of glycemic control among newly diagnosed type-2 diabetes patients according to gender using a multi-clinic retrospective cohort study. Optimal glycemic control was defined as hemoglobin A1c (HbA1c) of less than 6.5% after 1 year of diabetes management. A generalized linear mixed model, which controlled for the fixed effects of baseline characteristics and prescribed oral hypoglycemic agent (OHA), was used to calculate the probability of achieving the target HbA1c. The study included 2,253 newly diagnosed type-2 diabetes patients who completed 1 year of diabetic management, including OHA, in the 36 participating primary clinics. Within the study population, the women had an older average age, were less likely to smoke or drink alcohol, and showed lower levels of fasting blood glucose and HbA1c at the time of diagnosis. There were no significant differences by sex in prescribed OHA or median number of visits. After 1 year of diabetes management, 38.9% of women and 40.6% of men achieved the target HbA1c-a small but significant difference. This suggests that type-2 diabetes is managed less well in women than in men.

Effects of Achieving Target Measures in Rheumatoid Arthritis on Functional Status, Quality of Life, and Resource Utilization: Analysis of Clinical Practice Data.

PubMed

Alemao, Evo; Joo, Seongjung; Kawabata, Hugh; Al, Maiwenn J; Allison, Paul D; Rutten-van Mölken, Maureen P M H; Frits, Michelle L; Iannaccone, Christine K; Shadick, Nancy A; Weinblatt, Michael E

2016-03-01

To evaluate associations between achieving guideline-recommended targets of disease activity, defined by the Disease Activity Score in 28 joints using C-reactive protein level (DAS28-CRP) <2.6, the Simplified Disease Activity Index (SDAI) ≤3.3, or the Clinical Disease Activity Index (CDAI) ≤2.8, and other health outcomes in a longitudinal observational study. Other defined thresholds included low disease activity (LDA), moderate (MDA), or severe disease activity (SDA). To control for intraclass correlation and estimate effects of independent variables on outcomes of the modified Health Assessment Questionnaire (M-HAQ), the EuroQol 5-domain (EQ-5D; a quality-of-life measure), hospitalization, and durable medical equipment (DME) use, we employed mixed models for continuous outcomes and generalized estimating equations for binary outcomes. Among 1,297 subjects, achievement (versus nonachievement) of recommended disease targets was associated with enhanced physical functioning and lower health resource utilization. After controlling for baseline covariates, achievement of disease targets (versus LDA) was associated with significantly enhanced physical functioning based on SDAI ≤3.3 (ΔM-HAQ -0.047; P = 0.0100) and CDAI ≤2.8 (-0.073; P = 0.0003) but not DAS28-CRP <2.6 (-0.022; P = 0.1735). Target attainment was associated with significantly improved EQ-5D (0.022-0.096; P < 0.0030 versus LDA, MDA, or SDA). Patients achieving guideline-recommended disease targets were 36-45% less likely to be hospitalized (P < 0.0500) and 23-45% less likely to utilize DME (P < 0.0100). Attaining recommended target disease-activity measures was associated with enhanced physical functioning and health-related quality of life. Some health outcomes were similar in subjects attaining guideline targets versus LDA. Achieving LDA is a worthy clinical objective in some patients. © 2016 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

Creating the Business Case for Achieving Health Equity.

PubMed

Chin, Marshall H

2016-07-01

Health care organizations have increasingly acknowledged the presence of health care disparities across race/ethnicity and socioeconomic status, but significantly fewer have made health equity for diverse patients a true priority. Lack of financial incentives is a major barrier to achieving health equity. To create a business case for equity, governmental and private payors can: 1) Require health care organizations to report clinical performance data stratified by race, ethnicity, and socioeconomic status. 2) Incentivize preventive care and primary care. Implement more aggressive shared savings plans, update physician relative value unit fee schedules, and encourage partnerships across clinical and non-clinical sectors. 3) Incentivize the reduction of health disparities with equity accountability measures in payment programs. 4) Align equity accountability measures across public and private payors. 5) Assist safety-net organizations. Provide adequate Medicaid reimbursement, risk-adjust clinical performance scores for sociodemographic characteristics of patients, provide support for quality improvement efforts, and calibrate cuts to Disproportionate Share Hospital (DSH) payments to the pace of health insurance expansion. 6) Conduct demonstration projects to test payment and delivery system reform interventions to reduce disparities. Commitment to social justice is essential to achieve health equity, but insufficient without a strong business case that makes interventions financially feasible.

Impact of a Resident-as-Teacher Workshop on Teaching Behavior of Interns and Learning Outcomes of Medical Students

PubMed Central

Hill, Andrew G.; Srinivasa, Sanket; Hawken, Susan J.; Barrow, Mark; Farrell, Susan E.; Hattie, John; Yu, Tzu-Chieh

2012-01-01

Background Residents and interns are recognized as important clinical teachers and mentors. Resident-as-teacher training programs are known to improve resident attitudes and perceptions toward teaching, as well as their theoretical knowledge, skills, and teaching behavior. The effect of resident-as-teacher programs on learning outcomes of medical students, however, remains unknown. An intervention cohort study was conducted to prospectively investigate the effects of a teacher-training workshop on teaching behavior of participating interns and on the clerkship learning outcomes of instructed fourth-year medical students. Methods The House Officer-as-Teacher Training Workshop was implemented in November 2009 over 1.5 days and attended by all 34 interns from one teaching hospital. Subsequently, between February and August 2010, 124 fourth-year medical students rated the observable teaching behavior of interns during 6-week general surgery clerkships at this intervention hospital as well as at 2 comparable hospitals serving as control sites. Ratings were collected using an anonymous 15-item Intern Clinical Teaching Effectiveness Instrument. Student achievement of clerkship learning outcomes during this period was evaluated using a validated and centralized objective structured clinical examination. Results Medical students completed 101 intern clinical teaching effectiveness instruments. Intern teaching behavior at the intervention hospital was found to be significantly more positive, compared with observed behavior at the control hospitals. Objective structured clinical examination results, however, did not demonstrate any significant intersite differences in student achievement of general surgery clerkship learning outcomes. Conclusions The House Officer-as-Teacher Training Workshop noticeably improved teaching behavior of surgical interns during general surgery clerkships. This improvement did not, however, translate into improved achievement of clerkship learning outcomes by medical students during the study period. PMID:23451304

Application of Attachment Theory in Clinical Social Work.

PubMed

Blakely, Thomas Joseph; Dziadosz, Gregory M

2015-11-01

This article proposes the use of attachment theory in clinical social work practice. This theory is very appropriate in this context because of its fit with social work concepts of person-in-situation, the significance of developmental history in the emergence of psychosocial problems, and the content of human behavior in the social environment. A literature review supports the significance of the theory. Included are ideas about how attachment styles and working models may be used in assessment and treatment to help clients achieve a secure attachment style.

Achieving symptomatic remission in out-patients with schizophrenia--a naturalistic study with quetiapine.

PubMed

Wobrock, T; Köhler, J; Klein, P; Falkai, P

2009-08-01

Symptomatic remission was defined as a score of mild or less on each of eight key schizophrenia symptoms on the Positive and Negative Syndrome Scale (PANSS-8). To evaluate the symptomatic remission criterion in clinical practice and to determine predictors for achieving symptomatic remission, a 12-week non-interventional study (NIS) with quetiapine was conducted in Germany. For the comparison of patients with and without symptomatic remission, sociodemographic and clinical variables of 693 patients were analyzed by logistic regression for their predictive value to achieve remission. Four hundred and four patients (58.3%) achieved symptomatic remission after 12 weeks' treatment with quetiapine. Remission was significantly predicted by a low degree of PANSS-8 total score, PANSS single items blunted affect (N1), social withdrawal (N4), lack of spontaneity (N6), mannerism and posturing (G5), and low disease severity (CGI-S) at baseline. Predictors of non-remission were older age, diagnosis of schizophrenic residuum, multiple previous episodes, longer duration of current episode, presence of concomitant diseases, and alcohol abuse. This study demonstrated that the majority of schizophrenia out-patients achieved symptomatic remission after 12 weeks treatment and confirms the importance of managing negative symptoms in order to achieve disease remission.

Dental Students' Clinical Experience Across Three Successive Curricula at One U.S. Dental School.

PubMed

White, Joel M; Jenson, Larry E; Gansky, Stuart A; Walsh, Cameron J; Accurso, Brent T; Vaderhobli, Ram M; Kalenderian, Elsbeth; Walji, Muhammad F; Cheng, Jing

2017-04-01

As dental schools continue to seek the most effective ways to provide clinical education for students, it is important to track the effects innovations have on students' clinical experience to allow for quantitative comparisons of various curricula. The aim of this study was to compare the impact of three successive clinical curricula on students' experience at one U.S. dental school. The three were a discipline-based curriculum (DBC), a comprehensive care curriculum (CCC), and a procedural requirement curriculum plus externships (PRCE). Students' clinic experience data from 1992 to 2013 were analyzed for total experience and in five discipline areas. Clinic experience metrics analyzed were patient visits (PVs), relative value units (RVUs), and equivalent amounts (EQAs). A minimum experience threshold (MET) and a high experience threshold (HET) were set at one standard deviation above and below the mean for the DBC years. Students below the MET were designated as low achievers; students above the HET were designated as high achievers. The results showed significant differences among the three curricula in almost all areas of comparison: total PVs, total EQAs, total RVUs, RVUs by discipline, and number of high and low achievers in total clinical experience and by discipline. The comprehensive care approach to clinical education did not negatively impact students' clinical experience and in many cases enhanced it. The addition of externships also enhanced student total clinical experience although more study is needed to determine their effectiveness. The insights provided by this study suggest that the methodology used including the metrics of PVs, EQAs, and RVUs may be helpful for other dental schools in assessing students' clinical experience.

Low dose naltrexone for induction of remission in Crohn's disease.

PubMed

Parker, Claire E; Nguyen, Tran M; Segal, Dan; MacDonald, John K; Chande, Nilesh

2018-04-01

Crohn's disease is a transmural, relapsing inflammatory condition afflicting the digestive tract. Opioid signalling, long known to affect secretion and motility in the gut, has been implicated in the inflammatory cascade of Crohn's disease. Low dose naltrexone, an opioid antagonist, has garnered interest as a potential therapy. The primary objective was to evaluate the efficacy and safety of low dose naltrexone for induction of remission in Crohn's disease. A systematic search of MEDLINE, Embase, PubMed, CENTRAL, and the Cochrane IBD Group Specialized Register was performed from inception to 15 January 2018 to identify relevant studies. Abstracts from major gastroenterology conferences including Digestive Disease Week and United European Gastroenterology Week and reference lists from retrieved articles were also screened. Randomized controlled trials of low dose naltrexone (LDN) for treatment of active Crohn's disease were included. Data were analyzed on an intention-to-treat basis using Review Manager (RevMan 5.3.5). The primary outcome was induction of clinical remission defined by a Crohn's disease activity index (CDAI) of < 150 or a pediatric Crohn's disease activity index (PCDAI) of < 10. Secondary outcomes included clinical response (70- or 100-point decrease in CDAI from baseline), endoscopic remission or response, quality of life, and adverse events as defined by the included studies. Risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. The methodological quality of included studies was evaluated using the Cochrane risk of bias tool. The overall quality of the evidence supporting the primary outcome and selected secondary outcomes was assessed using the GRADE criteria. Two studies were identified (46 participants). One study assessed the efficacy and safety of 12 weeks of LDN (4.5 mg/day) treatment compared to placebo in adult patients (N = 34). The other study assessed eight weeks of LDN (0.1 mg/kg, maximum 4.5 mg/day) treatment compared to placebo in pediatric patients (N = 12). The primary purpose of the pediatric study was to assess safety and tolerability. Both studies were rated as having a low risk of bias. The study in adult patients reported that 30% (5/18) of LDN treated patients achieved clinical remission at 12 weeks compared to 18% (3/16) of placebo patients, a difference that was not statistically significant (RR 1.48, 95% CI 0.42 to 5.24). The study in children reported that 25% of LDN treated patients achieved clinical remission (PCDAI < 10) compared to none of the patients in the placebo group, although it was unclear if this result was for the randomized placebo-controlled trial or for the open label extension study. In the adult study 70-point clinical response rates were significantly higher in those treated with LDN than placebo. Eighty-three per cent (15/18) of LDN patients had a 70-point clinical response at week 12 compared to 38% (6/16) of placebo patients (RR 2.22, 95% CI 1.14 to 4.32). The effect of LDN on the proportion of adult patients who achieved a 100-point clinical response was uncertain. Sixty-one per cent (11/18) of LDN patients achieved a 100-point clinical response compared to 31% (5/16) of placebo patients (RR 1.96, 95% CI 0.87 to 4.42). The proportion of patients who achieved endoscopic response (CDEIS decline > 5 from baseline) was significantly higher in the LDN group compared to placebo. Seventy-two per cent (13/18) of LDN patients achieved an endoscopic response compared to 25% (4/16) of placebo patients (RR 2.89; 95% CI 1.18 to 7.08). However, there was no statistically significant difference in the proportion of patients who achieved endoscopic remission. Endoscopic remission (CDEIS < 3) was achieved in 22% (4/18) of the LDN group compared to 0% (0/16) of the placebo group (RR 8.05; 95% CI 0.47 to 138.87). Pooled data from both studies show no statistically significant differences in withdrawals due to adverse events or specific adverse events including sleep disturbance, unusual dreams, headache, decreased appetite, nausea and fatigue. No serious adverse events were reported in either study. GRADE analyses rated the overall quality of the evidence for the primary and secondary outcomes (i.e. clinical remission, clinical response, endoscopic response, and adverse events) as low due to serious imprecision (sparse data). Currently, there is insufficient evidence to allow any firm conclusions regarding the efficacy and safety of LDN used to treat patients with active Crohn's disease. Data from one small study suggests that LDN may provide a benefit in terms of clinical and endoscopic response in adult patients with active Crohn's disease. Data from two small studies suggest that LDN does not increase the rate of specific adverse events relative to placebo. However, these results need to be interpreted with caution as they are based on very small numbers of patients and the overall quality of the evidence was rated as low due to serious imprecision. Further randomized controlled trials are required to assess the efficacy and safety of LDN therapy in active Crohn's disease in both adults and children.

Visit-to-visit cholesterol variability correlates with coronary atheroma progression and clinical outcomes.

PubMed

Clark, Donald; Nicholls, Stephen J; St John, Julie; Elshazly, Mohamed B; Kapadia, Samir R; Tuzcu, E Murat; Nissen, Steven E; Puri, Rishi

2018-04-21

Utilizing serial intravascular ultrasonography (IVUS), we aimed to exam the association of intra-individual lipid variability, coronary atheroma progression, and clinical outcomes. We performed a post hoc patient-level analysis of nine clinical trials involving 4976 patients with coronary artery disease who underwent serial coronary IVUS in the setting of a range of medical therapies. We assessed the associations between progression in percent atheroma volume (ΔPAV), clinical outcomes, and visit-to-visit lipid variability including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol (TC)/HDL-C, and apolipoprotein B (ApoB). Variability of lipid parameters was measured using intra-individual standard deviation over 3, 6, 12, 18, and 24 months. Atherogenic lipoprotein variability significantly associated with ΔPAV [odds ratio (95% confidence interval; P-value), LDL-C: 1.09 (1.02, 1.17, P = 0.01); non-HDL-C: 1.10 (1.02, 1.18, P = 0.01); TC/HDL-C: 1.14 (1.06, 1.24, P = 0.001); ApoB: 1.13 (1.03, 1.24, P = 0.01)]. Survival curves revealed significant stepwise relationships between cumulative major adverse cardiovascular events and increasing quartiles of atherogenic lipoprotein variability at 24-months follow-up (log-rank P < 0.01 for all lipoproteins except HDL-C). Stronger associations were noted between achieved lipoprotein levels and ΔPAV [LDL-C: 1.27 (1.17, 1.39; P < 0.001); non-HDL-C: 1.32 (1.21, 1.45; P < 0.001); TC/HDL-C: 1.31 (1.19, 1.45; P < 0.001); ApoB: 1.20 (1.07, 1.35; P = 0.003)]. Greater visit-to-visit variability in atherogenic lipoprotein levels significantly associates with coronary atheroma progression and clinical outcomes, although the association between achieved atherogenic lipoproteins and atheroma progression appears stronger. These data highlight the importance of achieving low and consistent atherogenic lipoprotein levels to promote plaque regression and improve clinical outcomes.

Chasm in primary care provision in a universal health system: Findings from a nationally representative survey of health facilities in Malaysia

PubMed Central

Sivasampu, Sheamini; Khoo, Ee Ming; Mohamad Noh, Kamaliah

2017-01-01

Background Malaysia has achieved universal health coverage since 1980s through the expansion of direct public provision, particularly in rural areas. However, no systematic examination of the rural-urban distribution of primary care services and resources has been conducted to date for policy impact evaluation. Methods We conducted a national cross-sectional survey of 316 public and 597 private primary care clinics, selected through proportionate stratified random sampling, from June 2011 through February 2012. Using a questionnaire developed based on the World Health Organization toolkits on monitoring health systems strengthening, we examined the availability of primary care services/resources and the associations between service/resource availability and clinic ownership, locality, and patient load. Data were weighted for all analyses to account for the complex survey design and produce unbiased national estimates. Results Private primary care clinics and doctors outnumbered their public counterparts by factors of 5.6 and 3.9, respectively, but the private clinics were significantly less well-equipped with basic facilities and provided a more limited range of services. Per capita densities of primary care clinics and workforce were higher in urban areas (2.2 clinics and 15.1 providers per 10,000 population in urban areas versus 1.1 clinics and 11.7 providers per 10,000 population in rural areas). Within the public sector, the distribution of health services and resources was unequal and strongly favored the urban clinics. Regression analysis revealed that rural clinics had lower availability of services and resources after adjusting for ownership and patient load, but the associations were not significant except for workforce availability (adjusted odds ratio [OR]: 0.82; 95% confidence interval [CI]: 0.71–0.96). Conclusions Targeted primary care expansion in rural areas could be an effective first step towards achieving universal health coverage, especially in countries with limited healthcare resources. Nonetheless, geographic expansion alone is inadequate to achieve effective coverage in a dichotomous primary care system, and the role of the private sector in primary care delivery should not be overlooked. PMID:28196113

Chasm in primary care provision in a universal health system: Findings from a nationally representative survey of health facilities in Malaysia.

PubMed

Lim, Huy Ming; Sivasampu, Sheamini; Khoo, Ee Ming; Mohamad Noh, Kamaliah

2017-01-01

Malaysia has achieved universal health coverage since 1980s through the expansion of direct public provision, particularly in rural areas. However, no systematic examination of the rural-urban distribution of primary care services and resources has been conducted to date for policy impact evaluation. We conducted a national cross-sectional survey of 316 public and 597 private primary care clinics, selected through proportionate stratified random sampling, from June 2011 through February 2012. Using a questionnaire developed based on the World Health Organization toolkits on monitoring health systems strengthening, we examined the availability of primary care services/resources and the associations between service/resource availability and clinic ownership, locality, and patient load. Data were weighted for all analyses to account for the complex survey design and produce unbiased national estimates. Private primary care clinics and doctors outnumbered their public counterparts by factors of 5.6 and 3.9, respectively, but the private clinics were significantly less well-equipped with basic facilities and provided a more limited range of services. Per capita densities of primary care clinics and workforce were higher in urban areas (2.2 clinics and 15.1 providers per 10,000 population in urban areas versus 1.1 clinics and 11.7 providers per 10,000 population in rural areas). Within the public sector, the distribution of health services and resources was unequal and strongly favored the urban clinics. Regression analysis revealed that rural clinics had lower availability of services and resources after adjusting for ownership and patient load, but the associations were not significant except for workforce availability (adjusted odds ratio [OR]: 0.82; 95% confidence interval [CI]: 0.71-0.96). Targeted primary care expansion in rural areas could be an effective first step towards achieving universal health coverage, especially in countries with limited healthcare resources. Nonetheless, geographic expansion alone is inadequate to achieve effective coverage in a dichotomous primary care system, and the role of the private sector in primary care delivery should not be overlooked.

Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains.

PubMed

Verdijk, Pauline; Rots, Nynke Y; Bakker, Wilfried A M

2011-05-01

Following achievement of polio eradication, the routine use of all live-attenuated oral poliovirus vaccines should be discontinued. However, the costs per vaccine dose for the alternative inactivated poliovirus vaccine (IPV) are significantly higher and the current production capacity is not sufficient for worldwide distribution of the vaccine. In order to achieve cost-prize reduction and improve affordability, IPV production processes and dose-sparing strategies should be developed to facilitate local manufacture at a relatively lower cost. The use of attenuated Sabin instead of wild-type polio strains will provide additional safety during vaccine production and permits production in low-cost settings. Sabin-IPV is under development by several manufacturers. This article gives an overview of results from clinical trials with Sabin-IPV and discusses the requirements and challenges in the clinical development of this novel IPV.

Assessment of the Siksika chronic disease nephropathy-prevention clinic

PubMed Central

Ward, David R.R.; Novak, Ellen; Scott-Douglas, Nairne; Brar, Sony; White, Melvin; Hemmelgarn, Brenda R.

2013-01-01

Objective To determine if a community-based multifactorial intervention clinic led by a nurse practitioner would improve management of First Nations people at risk of developing chronic kidney disease. Design Qualitative descriptive study. Setting A nephropathy-prevention clinic in Siksika Nation, Alta. Participants First Nations people with diabetes, hypertension, or dyslipidemia who were referred to the clinic. Main outcome measures Changes in blood pressure (BP), hemoglobin A1c, and low-density lipoprotein levels, as well as in use of antiplatelet therapy, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker medications, and statin therapy. Results Members of the Siksika Nation were treated according to clinical practice guidelines. A total of 78 patients had at least 2 visits to the clinic and were included in this analysis (61.5% were women; mean age 56 years). Among those initially above target, a significant reduction was achieved in mean hemoglobin A1c (0.96%; P < .01), systolic BP (15.84 mm Hg; P < .05), diastolic BP (7.16 mm Hg; P < .001), and low-density lipoprotein (0.62 mmol/L; P < .01) levels. There was a significant increase in the proportion of patients with clinical indications who were treated with acetylsalicylic acid (42.4%; P < .01), angiotensin-converting enzyme inhibitor or angiotensin receptor blocker medications (35.9%; P < .01), or statin therapy (35.9%; P < .01). Conclusion A community-based, nurse practitioner–led clinic can improve many clinically relevant factors in patients at risk of developing chronic kidney disease. Studies have shown that achieving treatment targets is associated with a reduced risk of early death and cardiovascular events; the effect in the First Nations population on these hard clinical end points remains to be determined. PMID:23341675

[Efficacy of fluticasone propionate aerosol versus budesonide suspension in treatment of recurrent wheezing caused by bronchiolitis].

PubMed

Lan, Wei-Ping; Wang, Jing; Dai, Chuan-Lin; Pan, Jia-Hua

2016-04-01

To investigate the efficacy of fluticasone propionate aerosol (flixotide) versus budesonide suspension in the treatment of recurrent wheezing caused by bronchiolitis. A total of 214 infants with newly diagnosed bronchiolitis were randomly divided into flixotide treatment (106 infants) and budesonide treatment groups (108 infants), and were given aerosol inhalation of flixotide or budesonide for 3 months after achieving remission of clinical symptoms. Another 136 infants with bronchiolitis who did not receive regular inhalation of corticosteroid after achieving remission of clinical symptoms were enrolled as the control group. The follow-up visits were performed for 1 year, and the effects of the two therapeutic methods on recurrent wheezing were evaluated. Compared with the control group, both the flixotide and budesonide treatment groups had significantly fewer times of wheezing episodes within 1 year and a significantly lower recurrence rate of wheezing within the first 3 months after regular inhalation of corticosteroid, but no significant differences were observed between the two treatment groups. The amount of corticosteroid inhaled and hospital costs in the budesonide treatment group were significantly higher than in the flixotide treatment group (P<0.01). Continuous inhalation of flixotide or budesonide after remission of clinical symptoms in children with bronchiolitis can reduce wheezing episodes and the recurrence of wheezing, and flixotide treatment is superior to budesonide treatment in the aspects of hospital costs and the amount of corticosteroid used.

Managing statin-induced muscle toxicity in a lipid clinic.

PubMed

Blaier, O; Lishner, M; Elis, A

2011-06-01

Muscle toxicity is the most significant adverse effect related to statins. The aim of the study was to analyse the clinical course and achievement of LDL-C target levels in patients with statin-induced muscle toxicity. All patients who were referred to the lipid clinic because of statin-induced muscle toxicity, or developed it during follow-up, or did not reach LDL-C target levels because of its previous occurrence, and attended the clinic for at least three follow-up visits, were eligible. Files were reviewed for demographic and clinical parameters, coronary heart disease risk level, the severity of muscle injury, the type of statin and dose that caused the adverse effects, the clinical approach and outcome, and whether the LDL-C target level was achieved. The study group consisted of 54 patients. Twenty-three (43%) patients complained of myalgia, 23 (43%) had asymptomatic serum creatine kinase (CK) level elevation, five (9%) had myopathy and three (5%) had rhabdomyolysis. Fifty of the patients (93%) continued statin therapy and 43 (80%) achieved the LDL-C target level. We show that for the majority of patients with statin-induced muscle toxicity, statin therapy can be safely and effectively continued. In cases of asymptomatic CK levels <3-5 upper limit of normal (ULN), statin treatment should not be interrupted. When CK levels >3-5 ULN or when various symptomatic muscle adverse reactions are present, statins rechallenge, after a recovery period, should be individualized either by a low dose of a potent statin or by a less potent statin. An additional lipid medication is advised if the target levels are not achieved. © 2011 Blackwell Publishing Ltd.

Introduction: the goals of antimicrobial therapy.

PubMed

Song, Jae-Hoon

2003-03-01

Antimicrobial agents are generally evaluated in preclinical studies assessing in vitro activity, animal models demonstrating in vivo bacteriologic efficacy, and clinical trials primarily investigating safety and clinical efficacy. However, large sample sizes are required to detect any differences in outcomes between antimicrobials in clinical trials, and, generally, studies are powered to show only clinical equivalence. In addition, diagnosis is often based on clinical symptoms, rather than microbiological evidence of bacterial infection, and the patients most likely to have resistant pathogens are often excluded. Clinical efficacy can be achieved in some bacterial infections in which antimicrobials are suboptimal or even not prescribed. However, bacterial eradication maximizes clinical efficacy and may also reduce the development and spread of resistant organisms. The goal of antimicrobial therapy is, therefore, to eradicate bacteria at the site of infection. Bacterial eradication is not usually assessed as a primary endpoint within the limits of currently recommended clinical trial design. However, pharmacokinetic (PK) (serum concentration profiles, penetration to site of infection) and pharmacodynamic (PD) (susceptibility, concentration- versus time-dependent killing, post-antimicrobial effects) criteria can be used to predict bacteriologic efficacy. PK/PD predictions should be confirmed during all phases of antimicrobial development and throughout clinical use in response to changing patterns of resistance. A clear rationale for dose recommendations can be determined preclinically based on PK/PD parameters, and correlated with efficacy, safety and resistance endpoints in clinical trials. The duration of treatment and dose should be the shortest that will reliably eradicate the pathogen(s), and that is safe and well tolerated. Currently available agents vary significantly in their ability to achieve PK/PD parameters necessary for bacteriologic eradication. Recommendations for appropriate antimicrobial therapy should be based on PK/PD parameters, with the aim of achieving the maximum potential for eradication of both existing and emerging resistant pathogens.

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

PubMed

Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

2016-11-14

The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Clinically significant and sustained weight loss is achievable in obese women with polycystic ovary syndrome followed in a regular medical practice.

PubMed

Pelletier, Lysanne; Baillargeon, Jean-Patrice

2010-12-01

To determine the proportion of obese women with polycystic ovary syndrome (PCOS) losing clinically significant amounts of weight during a standard follow-up by an endocrinologist. Retrospective cohort study. Reproductive Endocrinology Clinic of an academic center. Obese patients with PCOS assessed between May 2002 and September 2008. General nonstandardized advice on weight loss and exercise. Proportion of women losing ≥5% or ≥10% of their initial weight at each of the following time interval: 2-6 months, 6-12 months, 12-18 months, 18-24 months, 24-36 months, and beyond 36 months. One hundred seventeen patients with PCOS and with a mean body mass index (BMI) of 38.7 kg/m(2) and mean age of 28.5 years were followed-up for a median duration of 21.9 months (range, 2.0-61.8 months), with a median of two visits per year. More than 40% of these women lost ≥5% of their initial weight after >6 months of follow-up, and ≥20% lost ≥10% after 1 year of follow-up. More important, these proportions were maintained up to ≥3 years. It is possible for obese women with PCOS to achieve clinically significant and sustained weight loss by following simple advices given in a regular clinical care setting. Therefore, practitioners should not underestimate their impact to facilitate weight loss in women with PCOS. Copyright © 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Mixed-state bipolar I and II depression: time to remission and clinical characteristics.

PubMed

Shim, In Hee; Woo, Young Sup; Jun, Tae-Youn; Bahk, Won-Myong

2014-01-01

We compared the time to achieve remission and the clinical characteristics of patients with bipolar depressive mixed state and those with bipolar depressive non-mixed state. The subjects (N=131) were inpatients diagnosed between 2006 and 2012 with bipolar I or II disorder, depression and were classified into the following three groups: "pure depressive state" (PD, n=70), "sub-threshold mixed state" (SMX, n=38), and "depressive mixed state" (DMX, n=23). Diagnosis of a DMX was in accordance with Benazzi's definition: three or more manic symptoms in a depressive episode. The subjects' charts were retrospectively reviewed to ascertain the time to achieve remission from the index episode and to identify other factors, such as demographic and clinical characteristics, specific manic symptoms, and pharmacological treatment, that may have contributed to remission. The time to achieve remission was significantly longer in the DMX (p=0.022) and SMX (p=0.035) groups than in the PD group. Adjustment for covariates using a Cox proportional hazards model did not change these results. Clinically, subjects with a DMX were more likely to have manic symptoms in the index episode, especially inflated self-esteem and psychomotor agitation than those in the PD. We investigated only inpatients and therefore could not comment on outpatients. These findings showed that sub-syndromal manic symptoms in bipolar depression had different clinical characteristics and a more severe illness course, including a longer time to achieve remission, than did a pure depressive state. © 2013 Elsevier B.V. All rights reserved.

The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.

PubMed

Sumi, Eriko; Teramukai, Satoshi; Yamamoto, Keiichi; Satoh, Motohiko; Yamanaka, Kenya; Yokode, Masayuki

2013-12-11

A number of clinical trials have encountered difficulties enrolling a sufficient number of patients upon initiating the trial. Recently, many screening systems that search clinical data warehouses for patients who are eligible for clinical trials have been developed. We aimed to estimate the number of eligible patients using routine electronic medical records (EMRs) and to predict the difficulty of enrolling sufficient patients prior to beginning a trial. Investigator-initiated clinical trials that were conducted at Kyoto University Hospital between July 2004 and January 2011 were included in this study. We searched the EMRs for eligible patients and calculated the eligible EMR patient index by dividing the number of eligible patients in the EMRs by the target sample size. Additionally, we divided the trial eligibility criteria into corresponding data elements in the EMRs to evaluate the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. We evaluated the correlation between the index and the accrual achievement with Spearman's rank correlation coefficient. Thirteen of 19 trials did not achieve their original target sample size. Overall, 55% of the trial eligibility criteria were mapped into data elements in EMRs. The accrual achievement demonstrated a significant positive correlation with the eligible EMR patient index (r = 0.67, 95% confidence interval (CI), 0.42 to 0.92). The receiver operating characteristic analysis revealed an eligible EMR patient index cut-off value of 1.7, with a sensitivity of 69.2% and a specificity of 100.0%. Our study suggests that the eligible EMR patient index remains exploratory but could be a useful component of the feasibility study when planning a clinical trial. Establishing a step to check whether there are likely to be a sufficient number of eligible patients enables sponsors and investigators to concentrate their resources and efforts on more achievable trials.

Goal setting in diabetes self-management: taking the baby steps to success.

PubMed

DeWalt, Darren A; Davis, Terry C; Wallace, Andrea S; Seligman, Hilary K; Bryant-Shilliday, Betsy; Arnold, Connie L; Freburger, Janet; Schillinger, Dean

2009-11-01

To evaluate the usefulness of a diabetes self-management guide and a brief counseling intervention in helping patients set and achieve their behavioral goals. We conducted a quasi-experimental study using a one group pretest posttest design to assess the effectiveness of a goal setting intervention along with a self-management guide. English- and Spanish-speaking patients with diabetes had one in-person session and two telephone follow-up calls with a non-clinical provider over a 12-16-week period. At each call and at the end of the study, we assessed success in achieving behavioral goals and problem solving toward those goals. Satisfaction with the self-management guide was assessed at the end of the study. We enrolled 250 patients across three sites and 229 patients completed the study. Most patients chose to set goals in diet and exercise domains. 93% of patients achieved at least one behavioral goal during the study and 73% achieved at least two behavioral goals. Many patients exhibited problem solving behavior to achieve their goals. We found no significant differences in reported achievement of behavior goals by literacy or language. Patients were very satisfied with the guide. A brief goal setting intervention along with a diabetes self-management guide helped patients set and achieve healthy behavioral goals. Non-clinical providers can successfully help a diverse range of patients with diabetes set and achieve behavioral goals.

SU-F-T-433: Evaluation of a New Dose Mimicking Application for Clinical Flexibility and Reliability

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

Hoffman, D; Nair, C Kumaran; Wright, C

2016-06-15

Purpose: Clinical workflow and machine down time occasionally require patients to be temporarily treated on a system other than the initial treatment machine. A new commercial dose mimicking application provides automated cross-platform treatment planning to expedite this clinical flexibility. The aim of this work is to evaluate the feasibility of automatic plan creation and establish a robust clinical workflow for prostate and pelvis patients. Methods: Five prostate and five pelvis patients treated with helical plans were selected for re-planning with the dose mimicking application, covering both simple and complex scenarios. Two-arc VMAT and 7- and 9-field IMRT plans were generatedmore » for each case, with the objective function of achieving similar dose volume histogram from the initial helical plans. Dosimetric comparisons include target volumes and organs at risk (OARs) (rectum, bladder, small bowel, femoral heads, etc.). Dose mimicked plans were evaluated by a radiation oncologist, and patient-specific QAs were performed to validate delivery. Results: Overall plan generation and transfer required around 30 minutes of dosimetrist’s time once the dose-mimicking protocol is setup for each site. The resulting VMAT and 7- and 9-field IMRT plans achieved equivalent PTV coverage and homogeneity (D99/DRx = 97.3%, 97.2%, 97.2% and HI = 6.0, 5.8, and 5.9, respectively), compared to helical plans (97.6% and 4.6). The OAR dose discrepancies were up to 6% in rectum Dmean, but generally lower in bladder, femoral heads, bowel and penile bulb. In the context of 1–5 fractions, the radiation oncologist evaluated the dosimetric changes as not clinically significant. All delivery QAs achieved >90% pass with a 3%/3mm gamma criteria. Conclusion: The automated dose-mimicking workflow offers a strategy to avoid missing treatment fractions due to machine down time with non-clinically significant changes in dosimetry. Future work will further optimize dose mimicking plans and investigate other cross-platform treatment delivery options.« less

Predicting methylphenidate response in attention deficit hyperactivity disorder: a preliminary study.

PubMed

Johnston, Blair A; Coghill, David; Matthews, Keith; Steele, J Douglas

2015-01-01

Methylphenidate (MPH) is established as the main pharmacological treatment for patients with attention deficit hyperactivity disorder (ADHD). Whilst MPH is generally a highly effective treatment, not all patients respond, and some experience adverse reactions. Currently, there is no reliable method to predict how patients will respond, other than by exposure to a trial of medication. In this preliminary study, we sought to investigate whether an accurate predictor of clinical response to methylphenidate could be developed for individual patients, using sociodemographic, clinical and neuropsychological measures. Of the 43 boys with ADHD included in this proof-of-concept study, 30 were classed as responders and 13 as non-responders to MPH, with no significant differences in age nor verbal intelligence quotient (IQ) between the groups. Here we report the application of a multivariate analysis approach to the prediction of clinical response to MPH, which achieved an accuracy of 77% (p = 0.005). The most important variables to the classifier were performance on a 'go/no go' task and comorbid conduct disorder. This preliminary study suggested that further investigation is merited. Achieving a highly significant accuracy of 77% for the prediction of MPH response is an encouraging step towards finding a reliable and clinically useful method that could minimise the number of children needlessly being exposed to MPH. © The Author(s) 2014.

Glycaemic outcomes of an Individualized treatMent aPproach for oldER vulnerable patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus (IMPERIUM)

PubMed Central

Heller, Simon R.; Pratley, Richard E.; Sinclair, Alan; Festa, Andreas; Brusko, Cynthia S.; Duan, Ran; Heine, Robert J.

2017-01-01

Aims To compare the glycaemic outcomes of 2 glucose‐lowering treatment strategies in vulnerable (moderately ill and/or frail) patients aged ≥65 years with type 2 diabetes whose individual HbA1c targets were not met with diet/exercise and/or oral anti‐hyperglycaemic medications (OAMs). Methods The primary endpoint of this study was a composite of achieving/maintaining individualized HbA1c targets without “clinically significant” hypoglycaemia (severe hypoglycaemia or repeated hypoglycaemia causing interruption of patients’ activities or blood glucose <54 mg/dL). Strategy‐A comprised glucose‐dependent therapies (n = 99) with a non‐sulphonylurea OAM and a glucagon‐like peptide‐1 receptor agonist as the first injectable. Strategy‐B comprised non‐glucose‐dependent therapies (n = 93) with sulphonylurea as the preferred OAM and insulin glargine as the first injectable. Results There was no significant difference between Strategy‐A and Strategy‐B in percentages of patients achieving the primary endpoint (64.5% vs 54.9%; P = .190). Mean incidences (A vs B) of total (10.2% vs 53.8%), documented symptomatic (5.1% vs 36.6%), and asymptomatic (8.2% vs 32.3%) hypoglycaemia were lower for Strategy‐A (P < .001 each). Proportions of patients achieving/maintaining HbA1c target (A, 63.3% vs B, 55.9%) were similar. Conclusion Similar proportions of older, vulnerable aged ≥65 years patients with type 2 diabetes achieved/maintained glycaemic treatment goals without clinically significant hypoglycaemia with Strategies A or B. However, Strategy‐A resulted in lower risk of total, documented symptomatic, and asymptomatic hypoglycaemia. These results identify an approach of potential clinical benefit in this age group and will inform future clinical research in older patients with type 2 diabetes. PMID:28671753

Impact of relational coordination on staff and patient outcomes in outpatient surgical clinics.

PubMed

Gittell, Jody Hoffer; Logan, Caroline; Cronenwett, Jack; Foster, Tina C; Freeman, Richard; Godfrey, Marjorie; Vidal, Dale Collins

2018-01-05

Pressures are increasing for clinicians to provide high-quality, efficient care, leading to increased concerns about staff burnout. This study asks whether staff well-being can be achieved in ways that are also beneficial for the patient's experience of care. It explores whether relational coordination can contribute to both staff well-being and patient satisfaction in outpatient surgical clinics where time constraints paired with high needs for information transfer increase both the need for and the challenge of achieving timely and accurate communication. We studied relational coordination among surgeons, nurses, residents, administrators, technicians, and secretaries in 11 outpatient surgical clinics. Data were combined from a staff and a patient survey to conduct a cross-sectional study. Data were analyzed using ordinary least squares and random effects regression models. Relational coordination among all workgroups was significantly associated with staff outcomes, including job satisfaction, work engagement, and burnout. Relational coordination was also significantly associated with patients' satisfaction with staff and their overall visit, though the association between relational coordination and patients' satisfaction with their providers did not reach statistical significance. Even when patient-staff interactions are relatively brief, as in outpatient settings, high levels of relational coordination among interdependent workgroups contribute to positive outcomes for both staff and patients, and low levels tend to have the opposite effect. Clinical leaders can increase the expectation of positive outcomes for both staff and their patients by implementing interventions to strengthen relational coordination.

Clinical and radiographic outcomes of bilateral decompression via a unilateral approach with transforaminal lumbar interbody fusion for degenerative lumbar spondylolisthesis with stenosis.

PubMed

Cheng, Xiaofei; Zhang, Kai; Sun, Xiaojiang; Zhao, Changqing; Li, Hua; Ni, Bin; Zhao, Jie

2017-08-01

Laminectomy with posterior lumbar interbody fusion (PLIF) has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft tissue structures. This study aimed to compare the clinical and radiographic outcomes of bilateral decompression via a unilateral approach (BDUA) with transforaminal lumbar interbody fusion (TLIF) and laminectomy with PLIF in the treatment of degenerative lumbar spondylolisthesis (DLS) with stenosis. This is a prospective cohort study. This study compared 43 patients undergoing BDUA+TLIF and 40 patients undergoing laminectomy+PLIF. Visual analog scale (VAS) for low back pain and leg pain, Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ) score. The clinical outcomes were assessed, and intraoperative data and complications were collected. Radiographic outcomes included slippage of the vertebra, disc space height, segmental lordosis, and final fusion rate. This study was supported by a grant from The National Natural Science Foundation of China (81572168). There were significant improvements in clinical and radiographic outcomes from before surgery to 3 months and 2 years after surgery within each group. Analysis of leg pain VAS and ZCQ scores showed no significant differences in improvement between groups at either follow-up. The mean improvements in low back pain VAS and ODI scores were significantly greater in the BDUA+TLIF group than in the laminectomy+PLIF group. No significant difference was found in the final fusion rate at 2-year follow-up. The BDUA+TLIF group had significantly less blood loss, shorter length of postoperative hospital stay, and lower complication rate compared with the laminectomy+PLIF group. When compared with the conventional laminectomy+PLIF procedure, the BDUA+TLIF procedure achieves similar and satisfactory effects of decompression and fusion for DLS with stenosis. The BDUA+TLIF procedure appears to be associated with less postoperative low back discomfort and quicker recovery. Copyright © 2017 Elsevier Inc. All rights reserved.

Antihypertensive effect of a fixed-dose combination of losartan/hydrochlorothiazide in patients with uncontrolled hypertension: a multicenter study.

PubMed

Hosoya, Tatsuo; Kuriyama, Satoru; Ohno, Iwao; Kawamura, Tetsuya; Ogura, Makoto; Ikeda, Masato; Ishikawa, Masahiro; Hayashi, Fumihiro; Kanai, Tatsuya; Tomonari, Haruo; Soejima, Michimasa; Akaba, Kiyoaki; Tokudome, Goro; Endo, S; Fukui, A; Gomi, H; Hamaguchi, A; Hanaoka, K; Hara, Y; Hara, Y; Hasegawa, T; Hayakawa, H; Hikida, M; Hirano, K; Horiguchi, M; Hosoya, M; Ichida, K; Imai, T; Ishii, T; Ishikawa, H; Kameda, C; Kasai, T; Kobayashi, A; Kobayashi, H; Kurashige, M; Kusama, Y; Maezawa, H; Maezawa, Y; Maruyama, Y; Matsuda, H; Matsuo, N; Matsuo, T; Miura, Y; Miyajima, M; Miyakawa, M; Miyazaki, Y; Mizuguchi, M; Nakao, M; Nokano, H; Ohkido, I; Ohtsuka, Y; Okada, K; Okamoto, H; Okonogi, H; Saikawa, H; Saito, H; Sekiguchi, C; Suetsugu, Y; Sugano, N; Suzuki, T; Suzuki, T; Takahashi, H; Takahashi, Y; Takamizawa, S; Takane, K; Morita, T; Takazoe, K; Tanaka, H; Tanaka, S; Terawaki, H; Toyoshima, R; Tsuboi, N; Udagawa, T; Ueda, H; Ueda, Y; Uetake, M; Unemura, S; Utsunomiya, M; Utsunomiya, Y; Yamada, T; Yamada, Y; Yamaguchi, Y; Yamamoto, H; Yokoo, T; Yokoyama, K; Yonezawa, H; Yoshida, H; Yoshida, M; Yoshizawa, T

2012-04-01

Achieving adequate blood pressure (BP) control often requires more than one antihypertensive agent. The purpose of this study was to determine whether a fixed-dose formulation of losartan (LOS) plus hydrochlorothiazide (HCTZ) (LOS/HCTZ) is effective in achieving a greater BP lowering in patients with uncontrolled hypertension. The study was a prospective, multicenter, observational trial exploring the antihypertensive effect of a single tablet of LOS 50 mg/HCTZ 12.5 mg. A total of 228 patients whose BP had previously been treated with more than one antihypertensive agents without having achieved BP goal below 130/80 mmHg enrolled in the study. A significant decrease in systolic and diastolic BP was observed in both clinic and home measurement after switching from the previous treatment to LOS/HCTZ. There was a significant decrease in both B-type natriuretic peptide (BNP) and urinary albumin creatinine (Cr) excretion ratio (ACR), especially in patients with elevated values. In contrast, there was a significant increase in serum Cr concentration in conjunction with a decrease in estimated glomerular filtration rate (eGFR). Overall serum uric acid (UA) concentration increased, whereas in patients with hyperuricemia there was a significant reduction in this value. Switching to LOS/HCTZ provides a greater reduction in clinic and home BP in patients with uncontrolled hypertension. This combination therapy may lead to cardio-, reno protection and improve UA metabolism.

An antimicrobial stewardship program's real-world experience with fidaxomicin for treatment of Clostridium difficile infection: a case series.

PubMed

Vargo, Craig A; Bauer, Karri A; Mangino, Julie E; Johnston, Jessica E W; Goff, Debra A

2014-09-01

To evaluate real-world clinical and economic outcomes in patients with Clostridium difficile infection (CDI) treated with fidaxomicin. Retrospective case series. Academic medical center. A total of 61 patients with CDI who were treated with fidaxomicin monotherapy or combination therapy from September 2011 to December 2012. Data on demographics, infection characteristics, and clinical and economic outcomes were evaluated. Clinical cure was defined as resolution of diarrhea (less than or equal to three unformed stools for at least 2 consecutive days) maintained for the duration of therapy with no further requirement for CDI therapy and was achieved in 44 (72.1%) patients. Clinical cure was significantly higher for patients receiving fidaxomicin monotherapy compared with fidaxomicin combination therapy (25/29 [86.2%] patients vs 19/32 [59.4%] patients, p=0.04). Clinical cure was similar in patients with a first or prior CDI episode (65.5% vs 78.1%, p=0.27) and in patients with severe versus nonsevere disease (68.4% vs 73.8%, p=0.66). Recurrence occurred in 6 (13.6%) of the 44 patients who achieved clinical cure. Mortality attributable to CDI was 11.5%, and 30-day readmission rate was 4.9%. Median cost accrued during CDI was $19,483/patient. Our real-world experience with fidaxomicin significantly differs from the findings of phase III clinical trials. Fidaxomicin is also associated with substantial costs. Multicenter studies are needed to determine the optimal role of fidaxomicin in the treatment of CDI. © 2014 Pharmacotherapy Publications, Inc.

Preliminary Analysis of a Randomized Trial of Computer Attention Training in Children with Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Steiner, N.; Sidhu, T. K.; Frenette, E. C.; Mitchell, K.; Perrin, E. C.

2011-01-01

Clinically significant attention problems among children present a significant obstacle to increasing student achievement. Computer-based attention training holds great promise as a way for schools to address this problem. The aim of this project is to evaluate the efficacy of two computer-based attention training systems in schools. One program…

The Effect of Patella Eversion on Clinical Outcome Measures in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.

PubMed

Zan, Pengfei; Wu, Zhong; Yu, Xiao; Fan, Lin; Xu, Tianyang; Li, Guodong

2016-03-01

During total knee arthroplasty (TKA), surgical exposure requires mobilization technique of the patella. With this trial, we intended to investigate the effect of patella eversion on clinical outcome measures in simultaneous bilateral TKA. We prospectively enrolled 44 patients (88 knees) from April 2008 to June 20l4.One knee was operated with patella eversion (group A) and the other with patella lateral retraction (group B) randomly. Follow-up results, including the operation time, complications, and the time of achieving straight leg raise (SLR) and 90° knee flexion, were recorded. The data of range of motion (ROM) and Visual Analogue Scale score were collected separately at 7 days, 3 months, 6 months, and 1 year postoperatively. The time of achieving SLR was 2.7 ± 0.8 days in group A and 2.1 ± 0.7 DAYS in group B, which were significantly different (P = .032). Significant difference was found on active and passive ROM during the follow-up times between groups A and B, except the passive ROM at 6 months postoperatively. No significant difference was found on operation time, complications, patella baja or tilt, time of achieving 90°knee flexion, and Visual Analogue Scale score during the follow-up times. Patellar eversion was adverse to the early knee function recovery after TKA; it would delay the time of achieving SLR and decrease the passive and active ROM. In addition, more carefully and scientifically designed randomized controlled trials are still required to further prove the claim. Copyright © 2016 Elsevier Inc. All rights reserved.

Novel biomarkers in critical care: utility or futility?

PubMed Central

Ackland, Gareth L; Mythen, Michael G

2007-01-01

One of the holy grails of modern medicine, across a range of clinical sub-specialties, is establishing highly sensitive and specific biomarkers for various diseases. Significant success has been achieved in some of these clinical areas, most notably identifying high-sensitivity C-reactive peptide, troponin I/T and brain natriuretic peptide as significant prognosticators for both the acute outcome and the development of cardiovascular pathology. However, it is highly debatable whether this translates to complex, multi-system pathophysiological insults. Is critical care immune from the application of these novel biomarkers, given the numerous confounding factors interfering with their interpretation? PMID:18001503

Immediate, non-submerged, root-analogue zirconia implant in single tooth replacement.

PubMed

Pirker, W; Kocher, A

2008-03-01

This report demonstrates the successful clinical use of a modified root-analogue zirconia implant for immediate single tooth replacement. A right maxillary premolar was removed and a custom-made, root-analogue, roughened zirconia implant with macro-retentions in the interdental space was fabricated and placed into the extraction socket 4 days later. Four months after root implantation a composite crown was cemented. No complications occurred during the healing period. An excellent esthetic and functional result was achieved with the composite crown. No clinically noticeable bone resorption or soft-tissue recession was observed at 26 months follow up. Significant modifications such as macro-retentions seem to indicate that primary stability and excellent osseointegration of immediate root-analogue zirconia implants can be achieved, while preventing unesthetic bone resorption. The macro-retentions must be limited to the interdental space to avoid fracture of the thin buccal cortex. This successful case warrants further clinical research in well controlled trials.

Fractional flow reserve-guided management in stable coronary disease and acute myocardial infarction: recent developments

PubMed Central

Berry, Colin; Corcoran, David; Hennigan, Barry; Watkins, Stuart; Layland, Jamie; Oldroyd, Keith G.

2015-01-01

Coronary artery disease (CAD) is a leading global cause of morbidity and mortality, and improvements in the diagnosis and treatment of CAD can reduce the health and economic burden of this condition. Fractional flow reserve (FFR) is an evidence-based diagnostic test of the physiological significance of a coronary artery stenosis. Fractional flow reserve is a pressure-derived index of the maximal achievable myocardial blood flow in the presence of an epicardial coronary stenosis as a ratio to maximum achievable flow if that artery were normal. When compared with standard angiography-guided management, FFR disclosure is impactful on the decision for revascularization and clinical outcomes. In this article, we review recent developments with FFR in patients with stable CAD and recent myocardial infarction. Specifically, we review novel developments in our understanding of CAD pathophysiology, diagnostic applications, prognostic studies, clinical trials, and clinical guidelines. PMID:26038588

Validation of the Clinical Learning Environment Inventory.

PubMed

Chan, Dominic S

2003-08-01

One hundred eight preregistration nursing students took part in this survey study, which assessed their perceptions of the clinical learning environment. Statistical data based on the sample confirmed the reliability and validity of the Clinical Learning Environment Inventory (CLEI), which was developed using the concept of classroom learning environment studies. The study also found that there were significant differences between students' actual and preferred perceptions of the clinical learning environments. In terms of the CLEI scales, students preferred a more positive and favorable clinical environment than they perceived as being actually present. The achievement of certain outcomes of clinical field placements might be enhanced by attempting to change the actual clinical environment in ways that make it more congruent with that preferred by the students.

Evaluation of a clinical TOF-PET detector design that achieves ⩽100 ps coincidence time resolution

NASA Astrophysics Data System (ADS)

Cates, Joshua W.; Levin, Craig S.

2018-06-01

Commercially available clinical positron emission tomography (PET) detectors employ scintillation crystals that are long (20 mm length) and narrow (4–5 mm width) optically coupled on their narrow end to a photosensor. The aspect ratio of this traditional crystal rod configuration and 511 keV photon attenuation properties yield significant variances in scintillation light collection efficiency and transit time to the photodetector, due to variations in the 511 keV photon interaction depth in the crystal. These variances contribute significant to coincidence time resolution degradation. If instead, crystals are coupled to a photosensor on their long side, near-complete light collection efficiency can be achieved, and scintillation photon transit time jitter is reduced. In this work, we compare the achievable coincidence time resolution (CTR) of LGSO:Ce(0.025 mol%) crystals 3–20 mm in length when optically coupled to silicon photomultipliers (SiPMs) on either their short end or long side face. In this ‘side readout’ configuration, a CTR of 102  ±  2 ps FWHM was measured with mm3 crystals coupled to rows of mm2 SensL-J SiPMs using leading edge time pickoff and a single timing channel. This is in contrast to a CTR of 137  ±  3 ps FWHM when the same crystals were coupled to single mm2 SiPMs on their narrow ends. We further study the statistical limit on CTR using side readout via the Cramér–Rao lower bound (CRLB), with consideration given to ongoing work to further improve photosensor technologies and exploit fast phenomena to ultimately achieve 10 ps FWHM CTR. Potential design aspects of scalable front-end signal processing readout electronics using this side readout configuration are discussed. Altogether, we demonstrate that the side readout configuration offers an immediate solution for 100 ps CTR clinical PET detectors and mitigates factors prohibiting future efforts to achieve 10 ps FWHM CTR.

Potential Strategies to Address the Major Clinical Barriers Facing Stem Cell Regenerative Therapy for Cardiovascular Disease: A Review.

PubMed

Nguyen, Patricia K; Neofytou, Evgenios; Rhee, June-Wha; Wu, Joseph C

2016-11-01

Although progress continues to be made in the field of stem cell regenerative medicine for the treatment of cardiovascular disease, significant barriers to clinical implementation still exist. To summarize the current barriers to the clinical implementation of stem cell therapy in patients with cardiovascular disease and to discuss potential strategies to overcome them. Information for this review was obtained through a search of PubMed and the Cochrane database for English-language studies published between January 1, 2000, and July 25, 2016. Ten randomized clinical trials and 8 systematic reviews were included. One of the major clinical barriers facing the routine implementation of stem cell therapy in patients with cardiovascular disease is the limited and inconsistent benefit observed thus far. Reasons for this finding are unclear but may be owing to poor cell retention and survival, as suggested by numerous preclinical studies and a small number of human studies incorporating imaging to determine cell fate. Additional studies in humans using imaging to determine cell fate are needed to understand how these factors contribute to the limited efficacy of stem cell therapy. Treatment strategies to address poor cell retention and survival are under investigation and include the following: coadministration of immunosuppressive and prosurvival agents, delivery of cardioprotective factors packaged in exosomes rather than the cells themselves, and use of tissue-engineering strategies to provide structural support for cells. If larger grafts are achieved using these strategies, it will be imperative to carefully monitor for the potential risks of tumorigenicity, immunogenicity, and arrhythmogenicity. Despite important achievements to date, stem cell therapy is not yet ready for routine clinical implementation. Significant research is still needed to address the clinical barriers outlined herein before the next wave of large clinical trials is under way.

Clinically inactive disease in a cohort of children with new-onset polyarticular juvenile idiopathic arthritis treated with early aggressive therapy: time to achievement, total duration, and predictors.

PubMed

Wallace, Carol A; Giannini, Edward H; Spalding, Steven J; Hashkes, Philip J; O'Neil, Kathleen M; Zeft, Andrew S; Szer, Ilona S; Ringold, Sarah; Brunner, Hermine I; Schanberg, Laura E; Sundel, Robert P; Milojevic, Diana S; Punaro, Marilynn G; Chira, Peter; Gottlieb, Beth S; Higgins, Gloria C; Ilowite, Norman T; Kimura, Yukiko; Johnson, Anne; Huang, Bin; Lovell, Daniel J

2014-06-01

To determine the elapsed time while receiving aggressive therapy to the first observation of clinically inactive disease (CID), total duration of CID and potential predictors of this response in a cohort of children with recent onset of polyarticular juvenile idiopathic arthritis (poly-JIA). Eighty-five children were randomized blindly to methotrexate (MTX), etanercept, and rapidly tapered prednisolone (MEP) or MTX monotherapy and assessed for CID over 1 year of treatment. Patients who failed to achieve intermediary endpoints were switched to open-label MEP treatment. Fifty-eight (68.2%) of the 85 patients achieved CID at 1 or more visits including 18 who received blinded MEP, 11 while receiving MTX monotherapy, and 29 while receiving open-label MEP. Patients starting on MEP achieved CID earlier and had more study days in CID compared to those starting MTX, but the differences were not significantly different. Patients given MEP (more aggressive therapy) earlier in the disease course were statistically more likely to have a higher proportion of followup visits in CID than those with longer disease course at baseline. Those who achieved American College of Rheumatology Pediatric 70 response at 4 months had a significantly greater proportion of followup visits in CID, compared to those who failed to achieve this improvement (p < 0.0001). Of the 32 patients who met criteria for CID and then lost CID status, only 3 fulfilled the definition of disease flare. Shorter disease duration prior to treatment, a robust response at 4 months, and more aggressive therapy result in a higher likelihood and longer duration of CID in patients with poly-JIA. The original trial from which data for this analysis were obtained is registered on www.clinicaltrials.gov NCT 00443430.

Sclerostin Antibody Therapy for the Treatment of Osteoporosis: Clinical Prospects and Challenges

PubMed Central

MacNabb, Claire; Patton, D.; Hayes, J. S.

2016-01-01

It is estimated that over 200 million adults worldwide have osteoporosis, a disease that has increasing socioeconomic impact reflected by unsustainable costs associated with disability, fracture management, hospital stays, and treatment. Existing therapeutic treatments for osteoporosis are associated with a variety of issues relating to use, clinical predictability, and health risks. Consequently, additional novel therapeutic targets are increasingly sought. A promising therapeutic candidate is sclerostin, a Wnt pathway antagonist and, as such, a negative regulator of bone formation. Sclerostin antibody treatment has demonstrated efficacy and superiority compared to other anabolic treatments for increasing bone formation in both preclinical and clinical settings. Accordingly, it has been suggested that sclerostin antibody treatment is set to achieve market approval by 2017 and aggressively compete as the gold standard for osteoporotic treatment by 2021. In anticipation of phase III trial results which may potentially signify a significant step in achieving market approval here, we review the preclinical and clinical emergence of sclerostin antibody therapies for both osteoporosis and alternative applications. Potential clinical challenges are also explored as well as ongoing developments that may impact on the eventual clinical application of sclerostin antibodies as an effective treatment of osteoporosis. PMID:27313945

Comparative effectiveness of hand scaling by undergraduate dental students following a two-week pre-clinical training course.

PubMed

Gartenmann, S J; Hofer, D; Wiedemeier, D; Sahrmann, P; Attin, T; Schmidlin, P R

2018-04-25

The Bologna reform resulted in a drastic restructuring of pre-clinical training courses at the University of Zurich. The aim of this study was to assess student pre-clinical scaling/root planning skills after just 8.5 hours of manual training. Three consecutive classes of dental students (n = 41; n = 34; n = 48) were tasked with removing lacquer concrement from the maxillary left canine on a typodont using Gracey and universal (Deppeler M23A) curettes. At baseline (prior to instruction), a timed 5-minute session of scaling/root planning was undertaken. The second scaling/root planning session was held immediately following training. Eight experienced dental hygienists and eight lay people served as positive and negative controls, using the same instruments and time limit, respectively. Instrumented teeth were collected, scanned and planimetrically analysed for the percentage of tooth surface cleaned. Statistical analyses were performed to assess the dental students' improvement after the training (Wilcoxon signed-rank test) and to compare it to that of laypeople and dental hygienists (Kruskal-Wallis rank sum test followed by Conover's post hoc test). At baseline, the dental students' mean scaling scores of the cleaned surfaces were not significantly different than those of laypeople (29.8%, 31.0%, 42% vs 27.9%). However, after 8.5 hours of manual training, the students' ability to clean the maxillary tooth improved significantly and they achieved mean removal values of 61.7%, 79.5% and 76% compared to the 67.4% (P < .001) of the experienced dental hygienists (Tables and ). There were no statistically significant differences between the scores achieved by students after training and those achieved by experienced dental hygienists. A shortened pre-clinical training time was sufficient for students to acquire the basic scaling/root planning skills needed in preparation for clinical training. Further research is needed to identify ways to help students consistently reach highest skill levels. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Risk factors of flare in rheumatoid arthritis patients with both clinical and ultrasonographic remission: a retrospective study from China.

PubMed

Han, Jingjing; Geng, Yan; Deng, Xuerong; Zhang, Zhuoli

2017-08-01

Ultrasonographic remission in addition to clinical remission is probably becoming a new target in the treatment of rheumatoid arthritis. The current study aimed to investigate the risk factors of flare in RA patients who achieved both clinical and ultrasonographic remission. RA patients fulfilled both clinical remission and ultrasonographic remissions were retrospectively enrolled in this study. Baseline clinical, laboratory, and ultrasonographic data were collected. Durations of clinical remission before enrollment and medication strategy during follow-up were recorded. Differences between the flare and the non-flare group were analyzed. Risk factors of flare were assessed with univariate and multivariate Cox proportional hazards models. One hundred and twenty-one RA patients were included. Forty-eight patients relapsed during a median follow-up period of 12.3 months. The flare group had higher percentage of females, shorter duration of clinical remission before enrollment, higher baseline ESR and DAS28 (ESR), and lower baseline gray scale score. Univariate Cox regression revealed female, short duration of remission, high DAS28 (ESR), and failure to achieve 2010 ACR/EULAR remission criteria were risk factors of flare. Furthermore, multivariate analysis showed short duration of remission was the only independent risk factor of flare (HR 0.93, 95% CI 0.88-0.98, P = 0.007). One more month in duration of remission led to a reduction in flare of 7.3%. Short duration of remission at baseline could be an independent risk factor of flare in RA patients who achieved both clinical and ultrasonographic remission, which implicates the significance of sustained remission in the prognosis of RA patients.

Self-regulated learning strategies used in surgical clerkship and the relationship with clinical achievement.

PubMed

Turan, Sevgi; Konan, Ali

2012-01-01

Self-regulated learning indicates students' skills in controlling their own learning. Self-regulated learning, which a context-specific process, emphasizes autonomy and control. Students gain more autonomy with respect to learning in the clinical years. Examining the self-regulated learning skills of students in this period will provide important clues about the level at which students are ready to use these skills in real-life conditions. The self-regulated learning strategies used by medical students in surgical clerkship were investigated in this study and their relation with clinical achievement was analyzed. The study was conducted during the surgery clerkship of medical students. The participation rate was 94% (309 students). Motivated Strategies for Learning Questionnaire (MSLQ), a case-based examination, Objective Structured Clinical Examination (OSCE), and tutor evaluations for assessing achievement were used. The relationship between the Motivated Strategies for Learning Questionnaire scores of the students and clinical achievement was analyzed with multilinear regression analysis. The findings showed that students use self-regulated learning skills at medium levels during their surgery clerkship. A relationship between these skills and OSCE scores and tutor evaluations was determined. OSCE scores of the students were observed to increase in conjunction with increased self-efficacy levels. However, as students' beliefs regarding control over learning increased, OSCE scores decreased. No significant relationship was defined between self-regulated learning skills and case-based examination scores. We observed that a greater self-efficacy for learning resulted in higher OSCE scores. Conversely, students who believe that learning is a result of their own effort had lower OSCE scores. Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project.

PubMed

Fisher, Jeffrey D; Amico, K Rivet; Fisher, William A; Cornman, Deborah H; Shuper, Paul A; Trayling, Cynthia; Redding, Caroline; Barta, William; Lemieux, Anthony F; Altice, Frederick L; Dieckhaus, Kevin; Friedland, Gerald

2011-11-01

We evaluated the efficacy of LifeWindows, a theory-based, computer-administered antiretroviral (ARV) therapy adherence support intervention, delivered to HIV + patients at routine clinical care visits. 594 HIV + adults receiving HIV care at five clinics were randomized to intervention or control arms. Intervention vs. control impact in the intent-to-treat sample (including participants whose ARVs had been entirely discontinued, who infrequently attended care, or infrequently used LifeWindows) did not reach significance. Intervention impact in the On Protocol sample (328 intervention and control arm participants whose ARVs were not discontinued, who attended care and were exposed to LifeWindows regularly) was significant. On Protocol intervention vs. control participants achieved significantly higher levels of perfect 3-day ACTG-assessed adherence over time, with sensitivity analyses maintaining this effect down to 70% adherence. This study supports the utility of LifeWindows and illustrates that patients on ARVs who persist in care at clinical care sites can benefit from adherence promotion software.

CLINICALLY SIGNIFICANT PSYCHOTROPIC DRUG-DRUG INTERACTIONS IN THE PRIMARY CARE SETTING

PubMed Central

English, Brett A.; Dortch, Marcus; Ereshefsky, Larry; Jhee, Stanford

2014-01-01

In recent years, the growing numbers of patients seeking care for a wide range of psychiatric illnesses in the primary care setting has resulted in an increase in the number of psychotropic medications prescribed. Along with the increased utilization of psychotropic medications, considerable variability is noted in the prescribing patterns of primary care providers and psychiatrists. Because psychiatric patients also suffer from a number of additional medical comorbidities, the increased utilization of psychotropic medications presents an elevated risk of clinically significant drug interactions in these patients. While life-threatening drug interactions are rare, clinically significant drug interactions impacting drug response or appearance of serious adverse drug reactions have been documented and can impact long-term outcomes. Additionally, the impact of genetic variability on the psychotropic drug’s pharmacodynamics and/or pharmacokinetics may further complicate drug therapy. Increased awareness of clinically relevant psychotropic drug interactions can aid clinicians to achieve optimal therapeutic outcomes in patients in the primary care setting. PMID:22707017

Efficacy of long-term 4.0 g/day mesalazine (Pentasa) for maintenance therapy in ulcerative colitis.

PubMed

Takeshima, Fuminao; Matsumura, Masato; Makiyama, Kazuya; Ohba, Kazuo; Yamakawa, Masaki; Nishiyama, Hitoshi; Yamao, Takuji; Akazawa, Yuko; Yamaguchi, Naoyuki; Ohnita, Ken; Ichikawa, Tatsuki; Isomoto, Hajime; Nakao, Kazuhiko

2014-07-27

High-dose (4.0 g/day) mesalazine is typically used for induction therapy, but its efficacy as maintenance therapy remains to be determined. We conducted a multicenter retrospective study to investigate the efficacy of continuous treatment with 4.0 g/day of mesalazine. Japanese ulcerative colitis (UC) patients receiving acute induction therapy with 4.0 g/day mesalazine were enrolled and followed. Those who clinically improved or who achieved clinical remission were categorized into 2 sub-groups according to the median duration of treatment with 4.0 g/day of mesalazine. The clinical relapse frequency and the time to relapse were analyzed. We enrolled 180 patients with active UC, and then 115 patients who clinically improved or who achieved clinical remission after treatment with 4.0 g/day mesalazine were categorized into 2 sub-groups according to the median of treatment duration: a short-term treatment group (≤105 days, n=58) and a long-term treatment group (>105 days, n=57). Overall, 45 (39.1%) patients relapsed: 28 (48.3%) in the short-term treatment group and 17 (29.8%) in the long-term treatment group. This difference was statistically significant (p<0.05). The relapse-free rate in the long-term treatment group was significantly higher than that in the short-term treatment group (p<0.05). The mean time to relapse in the long-term treatment group was significantly longer than that in the short-term treatment group (425.6±243.8 days vs. 277.4±224.5 days; p<0.05). Long-term continuous treatment with high-dose mesalazine (4.0 g/day) may be more effective than short-term treatment for maintenance of remission in UC patients.

[Educative strategy evaluation to improve critical reading skills on clinical research texts in second year gyneco-obstetrics residents].

PubMed

Carranza Lira, Sebastián; Arce Herrera, Rosa María; González González, Patricia

2007-11-01

The educative models and strategies to achieve a significant learning have a wide variety. The development of clinical aptitude for clinical research papers lecture has an important place to maintain the physician actualized and for resident formation. To evaluate the degree of development of the aptitude for the reading of clinical research articles in 2nd grade residents of the gynecology and obstetrics speciality alter an educative strategy. In 16 2nd year gynecology and obstetrics residents, a previously validated instrument was applied for the evaluation of critical lecture of clinical research articles in general medicine previous and after and educative strategy. Statistical analysis was with Kruskal-Wallis analysis of variance. Also Wilcoxon test was used to assess the differences between baseline and final results. The median of age was 27 (24-31) years, gender 56.3% women and 43.8% men. A statistically significant increase in global score was observed after the educative strategy. After it only there was a significant increase in the indicator to interpret. After evaluating the domain degrees according to the indicator to interpret, in baseline evaluation it predominated the very low level and at the final evaluation the very low and low levels. In the indicator to judge at baseline the majority were in the very low level, and at the end in very low and low levels. According to the indicator to propose at baseline all were in the level expected by hazard, and at the end a minimal proportion was at very low level. These results traduce a discrete improvement in critical lecture process, which makes to consider the educative strategy that was used, since the objective to improve critical lecture capacity was not achieved.

Low dose naltrexone for induction of remission in Crohn's disease.

PubMed

Segal, Dan; Macdonald, John K; Chande, Nilesh

2014-02-21

Crohn's disease is a transmural, relapsing inflammatory condition afflicting the digestive tract. Opioid signalling, long known to affect secretion and motility in the gut, has been implicated in the inflammatory cascade of Crohn's disease. Low dose naltrexone, an opioid antagonist, has garnered interest as a potential therapy. The primary objective was to evaluate the efficacy and safety of low dose naltrexone for induction of remission in Crohn's disease. A systematic search of MEDLINE, EMBASE, CENTRAL, and the Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Review Group Specialized Register was performed from inception to February 2013 to identify relevant studies. Abstracts from major gastroenterology conferences including Digestive Disease Week and United European Gastroenterology Week and reference lists from retrieved articles were also reviewed. Randomized controlled trials of low dose naltrexone (LDN) for treatment of active Crohn's disease were included. Data were analyzed on an intention-to-treat basis using Review Manager (RevMan 5.2). The primary outcome was induction of clinical remission defined by a Crohn's disease activity index (CDAI) of < 150 or a pediatric Crohn's disease activity index (PCDAI) of < 10. Secondary outcomes included clinical response (70- or 100-point decrease in CDAI from baseline), endoscopic remission or response, quality of life, and adverse events as defined by the included studies. Risk ratios (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. The methodological quality of included studies was evaluated using the Cochrane risk of bias tool. The overall quality of the evidence supporting the primary outcome and selected secondary outcomes was assessed using the GRADE criteria. Two studies were identified (46 participants). One study assessed the efficacy and safety of 12 weeks of LDN (4.5 mg/day) treatment compared to placebo in adult patients (N = 34). The other study assessed eight weeks of LDN (0.1 mg/kg, maximum 4.5 mg/day) treatment compared to placebo in pediatric patients (N = 12). The primary purpose of the pediatric study was to assess safety and tolerability. Both studies were rated as having a low risk of bias. The study in adult patients reported that 30% (5/18) of LDN treated patients achieved clinical remission at 12 weeks compared to 18% (3/16) of placebo patients, a difference that was not statistically significant (RR 1.48, 95% CI 0.42 to 5.24). The study in children reported that 25% of LDN treated patients achieved clinical remission (PCDAI < 10) compared to none of the patients in the placebo group, although it was unclear if this result was for the randomized placebo-controlled trial or for the open label extension study. In the adult study 70-point clinical response rates were significantly higher in those treated with LDN than placebo. Eighty-three per cent (15/18) of LDN patients had a 70-point clinical response at week 12 compared to 38% (6/16) of placebo patients (RR 2.22, 95% CI 1.14 to 4.32). The effect of LDN on the proportion of adult patients who achieved a 100-point clinical response was uncertain. Sixty-one per cent (11/18) of LDN patients achieved a 100-point clinical response compared to 31% (5/16) of placebo patients (RR 1.96, 95% CI 0.87 to 4.42). The proportion of patients who achieved endoscopic response (CDEIS decline > 5 from baseline) was significantly higher in the LDN group compared to placebo. Seventy-two per cent (13/18) of LDN patients achieved an endoscopic response compared to 25% (4/16) of placebo patients (RR 2.89; 95% CI 1.18 to 7.08). However, there was no statistically significant difference in the proportion of patients who achieved endoscopic remission. Endoscopic remission (CDEIS < 3) was achieved in 22% (4/18) of the LDN group compared to 0% (0/16) of the placebo group (RR 8.05; 95% CI 0.47 to 138.87). Pooled data from both studies show no statistically significant differences in withdrawals due to adverse events or specific adverse events including sleep disturbance, unusual dreams, headache, decreased appetite, nausea and fatigue. No serious adverse events were reported in either study. GRADE analyses rated the overall quality of the evidence for the primary and secondary outcomes (i.e. clinical remission, clinical response, endoscopic response, and adverse events) as low due to serious imprecision (sparse data). Currently, there is insufficient evidence to allow any firm conclusions regarding the efficacy and safety of LDN used to treat patients with active Crohn's disease. Data from one small study suggests that LDN may provide a benefit in terms of clinical and endoscopic response in adult patients with active Crohn's disease. Data from two small studies suggest that LDN does not increase the rate of specific adverse events relative to placebo. However, these results need to be interpreted with caution as they are based on very small numbers of patients and the overall quality of the evidence was rated as low due to serious imprecision. Further randomized controlled trials are required to assess the efficacy and safety of LDN therapy in active Crohn's disease in both adults and children. One study is currently ongoing (NCT01810185).

Percutaneous biliary drainage effectively lowers serum bilirubin to permit chemotherapy treatment.

PubMed

Levy, Jennifer L; Sudheendra, Deepak; Dagli, Mandeep; Mondschein, Jeffrey I; Stavropoulos, S William; Shlansky-Goldberg, Richard D; Trerotola, Scott O; Teitelbaum, Ursina; Mick, Rosemarie; Soulen, Michael C

2016-02-01

For digestive tract cancers, the bilirubin threshold for administration of systemic chemotherapy can be 5 or 2 mg/dL (85.5 or 34.2 μmol/L) depending upon the regimen. We examined the ability of percutaneous biliary drainage (PBD) in patients with malignant biliary obstruction to achieve these clinically relevant endpoints. 106 consecutive patients with malignant biliary obstruction and a baseline serum bilirubin >2 mg/dL underwent PBD. Time to achieve a bilirubin of 5 mg/dL (85.5 μmol/L), 2 mg/dL (34.2 μmol/L), and survival was estimated by Kaplan-Meier analysis. Potential technical and clinical prognostic factors were subjected to univariate and multivariate analysis. Categorical variables were analyzed by the log rank test. Hazard ratios were calculated for continuous variables. Median survival was 100 days (range 1-3771 days). Among 88 patients with a pre-drainage bilirubin >5 mg/dL, 62% achieved a serum bilirubin ≤5 mg/dL within 30 days and 84% within 60 days, median 21 days. Among 106 patients with a pre-drainage bilirubin >2 mg/dL, 37% achieved a serum bilirubin ≤2 mg/dL by 30 days and 70% within 60 days, median 43 days. None of the technical or clinical factors evaluated, including pre-drainage bilirubin, were significant predictors of time to achieve a bilirubin ≤2 mg/dL (p = 0.51). Size and type of biliary device were the only technical variables found to affect time to bilirubin of 5 mg/dL (p = 0.016). PBD of malignant obstruction achieves clinically relevant reduction in serum bilirubin in the majority of patients within 1-2 months, irrespective of the pre-drainage serum bilirubin, sufficient to allow administration of systemic chemotherapy. However, the decision to undergo this procedure for this indication alone must be considered in the context of patients' prognosis and treatment goals.

Goal setting in diabetes self-management: Taking the baby steps to success

PubMed Central

DeWalt, Darren A.; Davis, Terry C.; Wallace, Andrea S.; Seligman, Hilary K.; Bryant-Shilliday, Betsy; Arnold, Connie L.; Freburger, Janet; Schillinger, Dean

2014-01-01

Objective To evaluate the usefulness of a diabetes self-management guide and a brief counseling intervention in helping patients set and achieve their behavioral goals. Methods We conducted a quasi-experimental study using a one group pretest posttest design to assess the effectiveness of a goal setting intervention along with a self-management guide. English- and Spanish-speaking patients with diabetes had one in-person session and two telephone follow-up calls with a non-clinical provider over a 12–16-week period. At each call and at the end of the study, we assessed success in achieving behavioral goals and problem solving toward those goals. Satisfaction with the self-management guide was assessed at the end of the study. Results We enrolled 250 patients across three sites and 229 patients completed the study. Most patients chose to set goals in diet and exercise domains. 93% of patients achieved at least one behavioral goal during the study and 73% achieved at least two behavioral goals. Many patients exhibited problem solving behavior to achieve their goals. We found no significant differences in reported achievement of behavior goals by literacy or language. Patients were very satisfied with the guide. Conclusions A brief goal setting intervention along with a diabetes self-management guide helped patients set and achieve healthy behavioral goals. Practice implications Non-clinical providers can successfully help a diverse range of patients with diabetes set and achieve behavioral goals. PMID:19359123

Do Asian women do as well as their Caucasian counterparts in IVF treatment: Cohort study.

PubMed

Kan, Andrew; Leung, Peter; Luo, Kehui; Fay, Louise; Tan, Chunyan Leeann

2015-06-01

To evaluate if there is a difference in pregnancy rate between Asian and Caucasian women when they undergo in vitro fertilization (IVF). This was a retrospective cohort study set in a private reproductive medicine clinic. The study consisted of a total of 2594 patients (Asian, n = 522; Caucasian, n = 2072) undergoing IVF managed by a single doctor over a 10 year period. The main outcome measures were clinical pregnancy rate and live birth rate. Logistic regression was used to control for confounding factors. Asian women achieved a significantly lower clinical pregnancy and live birth rate than their Caucasian counterparts, despite replacement of more embryos. This difference was not significant after controlling for age and duration of infertility. Despite higher doses of gonadotrophin, they achieved fewer oocytes and had resultant fewer embryos for transfer or cryopreservation. In a study designed to reduce the effect of confounding factors by looking at a large number of patients from a single IVF unit under the care of a single doctor, there does not appear to be a difference in IVF pregnancy rate as a result of race. Asian women tend to present for IVF treatment at a later age after having tried for a longer period of time and this contributes significantly to their lower pregnancy rate. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

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.

A pilot Diabetic Support Service based on family practice attenders: comparison with diabetic clinics in east London.

PubMed

Boucher, B J; Claff, H R; Edmonson, M; Evans, S; Harris, B T; Hull, S A; Jones, E J; Mellins, D H; Safir, J G; Taylor, B

1987-01-01

A pilot Diabetic Support Service (DSS) based on a computer register was devised for diabetic patients identified within three group practices in an inner city district of London. Of 159 eligible diabetics, 142 were followed over 2 years. Glycosylated haemoglobin (GHb) monitoring and adequacy of clinic reviews were audited. Care achieved by the DSS was compared with conventional Diabetic Clinic (DC) management of a sample of 200 diabetics from the same district. Serial GHb measurements were made on 66.2% of DSS and 44.5% of DC patients: GHb fell significantly only in DSS patients (13.1% to 11.4%). Proportional falls in GHb were comparable in each DSS treatment group (diet alone, oral hypoglycaemic agents, and insulin) and for hospital attenders and non-attenders equally. The planned clinical reviews were achieved in 40.1% of DSS patients entered (29% GP only, 54% of clinic attenders) and in 15% of DC patients (plus 75% fundal and blood pressure examination). The study led to provision of a formal diabetic clinic annual review system, diabetic mini-clinics in two of the three group practices, and the appointment of two Diabetic Liaison Sisters. With administrative simplification the system is to be made available to all diabetics in the District through their GPs during 1986-8.

Outcomes of a Joint Replacement Surgical Home Model Clinical Pathway

PubMed Central

Chaurasia, Avinash; Garson, Leslie; Kain, Zeev L.; Schwarzkopf, Ran

2014-01-01

Optimizing perioperative care to provide maximum benefit at minimum cost may be best achieved using a perioperative clinical pathway (PCP). Using our joint replacement surgical home (JSH) model PCP, we examined length of stay (LOS) following total joint arthroplasty (TJA) to evaluate patient care optimization. We reviewed a spectrum of clinical measurements in 190 consecutive patients who underwent TJA. Patients who had surgery earlier in the week and who were earlier cases of the day had a significantly lower LOS than patients whose cases started both later in the week and later in the day. Patients discharged home had significantly lower LOS than those discharged to a secondary care facility. Patients who received regional versus general anesthesia had a significantly lower LOS. Scheduling patients discharged to home and who will likely receive regional anesthesia for the earliest morning slot and earlier in the week may help decrease overall LOS. PMID:25025045

Toward Personalized Pressure Ulcer Care Planning: Development of a Bioinformatics System for Individualized Prioritization of Clinical Pratice Guideline

DTIC Science & Technology

2016-10-01

and text data mining . A Spinal Cord Injury Pressure Ulcer and Deep tissue injury ontology, SCIPUDO, will be developed to ensure robust and extensive...on natural language programming and the need to convert text in to data for analysis. In progress c) Define Physio-MIMI based SCIPUD+ Resource...information extraction from the free text clinical note. 3) Significant Results Nothing to report 4) Other Achievements Nothing to report

Health Promotion for Young Adults With Serious Mental Illness.

PubMed

Naslund, John A; Aschbrenner, Kelly A; Scherer, Emily A; Pratt, Sarah I; Bartels, Stephen J

2017-02-01

Young adulthood represents a critical time to address elevated obesity rates and the risk of early mortality, particularly among people with serious mental illness. Few studies have assessed the benefits of lifestyle interventions targeting weight loss among these young adults. This study examined the impact of the 12-month In SHAPE lifestyle intervention on weight loss and fitness among overweight and obese young adults with serious mental illness (ages 21-30) compared with participants over age 30. Data were combined from three trials of the 12-month In SHAPE program delivered through community mental health centers. In SHAPE includes weekly fitness trainer meetings, a gym membership, and nutrition education. Primary outcomes were weight loss and change in fitness at 12 months. Participants (N=194) had a schizophrenia spectrum disorder (53%) or a mood disorder (47%). The overall sample achieved significant weight loss and improved fitness; differences between young adults (N=29) and participants over age 30 (N=165) were not significant. An important finding was that 42% of young adults achieved clinically significant reductions in cardiovascular risk, defined as ≥5% weight loss or improved fitness (>50-m increase on the 6-Minute Walk Test), compared with 54% of adults over age 30 (a nonsignificant difference between age groups). Among persons enrolled in a lifestyle intervention, overweight and obese young adults experienced benefits comparable with those of adults over age 30. Young adults with serious mental illness face high risk of gaining weight, but a meaningful proportion of these individuals can achieve clinically significant cardiovascular risk reduction, thus highlighting the need to promote lifestyle intervention participation in this group.

Health Promotion for Young Adults With Serious Mental Illness

PubMed Central

Naslund, John A.; Aschbrenner, Kelly A.; Scherer, Emily A.; Pratt, Sarah I.; Bartels, Stephen J.

2017-01-01

Objective Young adulthood represents a critical time to address elevated obesity rates and the risk of early mortality, particularly among people with serious mental illness. Few studies have assessed the benefits of lifestyle interventions targeting weight loss among these young adults. This study examined the impact of the 12-month In SHAPE lifestyle intervention on weight loss and fitness among overweight and obese young adults with serious mental illness (ages 21–30) compared with participants over age 30. Methods Data were combined from three trials of the 12-month In SHAPE program delivered through community mental health centers. In SHAPE includes weekly fitness trainer meetings, a gym membership, and nutrition education. Primary outcomes were weight loss and change in fitness at 12 months. Results Participants (N=194) had a schizophrenia spectrum disorder (53%) or a mood disorder (47%). The overall sample achieved significant weight loss and improved fitness; differences between young adults (N=29) and participants over age 30 (N=165) were not significant. An important finding was that 42% of young adults achieved clinically significant reductions in cardiovascular risk, defined as ≥5% weight loss or improved fitness (>50-m increase on the 6-Minute Walk Test), compared with 54% of adults over age 30 (a non-significant difference between age groups). Conclusions Among persons enrolled in a lifestyle intervention, overweight and obese young adults experienced benefits comparable with those of adults over age 30. Young adults with serious mental illness face high risk of gaining weight, but a meaningful proportion of these individuals can achieve clinically significant cardiovascular risk reduction, thus highlighting the need to promote lifestyle intervention participation in this group. PMID:27799016

Time to achieving therapeutic international normalized ratio increases hospital length of stay after heart valve replacement surgery.

PubMed

Arendt, Christopher J; Hong, Joon Hwa; Daly, Richard C; Scott, Christopher; Mehta, Ramila A; Bailey, Kent; Pathak, Jyotishman; Pereira, Naveen L

2017-05-01

Achieving a therapeutic international normalized ratio (INR) before hospital discharge is an important inpatient goal for patients undergoing mechanical cardiac valve replacement (MCVR). The use of clinical algorithms has reduced the time to achieve therapeutic INR (TTI) with warfarin therapy. Whether TTI prolongs length of stay (LOS) is unknown. Patients who underwent MCVR over a consecutive 42-month period were included. Clinical data were obtained from the Society of Thoracic Surgeons Adult Cardiac Surgery database and electronic medical records. Therapeutic INR was defined as per standard guidelines. Warfarin dose was prescribed using an inpatient pharmacy-managed algorithm and computer-based dosing tool. International normalized ratio trajectory, procedural needs, and drug interactions were included in warfarin dose determination. There were 708 patients who underwent MCVR, of which 159 were excluded for reasons that would preclude or interrupt warfarin use. Among the remainder of 549 patients, the average LOS was 6.4days and mean TTI was 3.5days. Landmark analysis showed that subjects in hospital on day 4 (n=542) who achieved therapeutic INR were more likely to be discharged by day 6 compared with those who did not achieve therapeutic INR (75% vs 59%, P<.001). Multivariable proportional hazards regression with TTI as a time-dependent effect showed a strong association with discharge (P=.0096, hazard ratio1.3) after adjustment for other significant clinical covariates. Time to achieve therapeutic INR is an independent predictor of LOS in patients requiring anticoagulation with warfarin after MCVR surgery. Alternative dosing and anticoagulation strategies will need to be adopted to reduce LOS in these patients. Copyright © 2017 Elsevier Inc. All rights reserved.

The role of social media in clinical excellence.

PubMed

Batt-Rawden, Samantha; Flickinger, Tabor; Weiner, John; Cheston, Christine; Chisolm, Margaret

2014-07-01

The provision of excellent patient care is a goal shared by all doctors. The role of social media (SM) in helping medical students and doctors achieve clinical excellence is unknown. Social media may help facilitate the achievement of clinical excellence This report aimed to identify examples of how SM may be used to help promote the achievement of clinical excellence in medical learners. Three of the authors previously conducted a systematic review of the published literature on SM use in undergraduate, graduate and continuing medical education. Two authors re-examined the 14 evaluative studies to identify any examples of SM use that may facilitate the achievement of clinical excellence and to consider whether there were any aspects of clinical excellence for which no studies had been performed, and, if so, whether SM was relevant to these domains. Each study touched on one or more of the following domains of clinical excellence: communication and interpersonal skills; professionalism and humanism; knowledge; diagnostic acumen; exhibiting a passion for patient care; a scholarly approach to clinical practice; and explicitly modelling expertise to medical trainees. No study addressed the role of SM to promote the skillful negotiation of the health care system, and in collaboration with investigators to advance science and discovery; however, additional evidence suggested that SM may play an adjunctive role in promoting the achievement of these aspects of clinical excellence. This report supports the hypothesis that SM may help facilitate the achievement of clinical excellence; however, further research is needed into the role of SM in promoting the achievement of clinical excellence. © 2014 John Wiley & Sons Ltd.

Evaluation of a vaccine passport to improve vaccine coverage in people living with HIV.

PubMed

Chadwick, D R; Corbett, K; Mann, S; Teruzzi, B; Horner, S

2018-01-01

An increased risk of vaccine-preventable infections (VPIs) is seen in people living with HIV (PLWH), and current vaccine coverage and immunity is variable. Vaccine passports have the potential to improve vaccine coverage. The objective was to assess how successful a vaccine passport was in improving vaccine coverage in PLWH. Baseline immunity to VPIs was established in PLWH attending a single HIV clinic and vaccinations required were determined based on the BHIVA Vaccination Guidelines (2015). The passport was completed and the PLWH informed about additional vaccines they should obtain from primary care. After 6-9 months the passport was reviewed including confirmation if vaccines were given. PLWH satisfaction with the system was evaluated by a survey. Seventy-three PLWH provided sufficient data for analysis. At baseline significant proportions of PLWH were not immune/unvaccinated to the main VPIs, especially human papillomavirus, pneumococcus and measles. After the passport was applied immunity improved significantly (56% overall, p < 0.01) for most VPIs; however, full coverage was not achieved. The system was popular with PLWH. The passport was successful in increasing vaccination coverage although full or near-full coverage was not achieved. A more successful service would probably be achieved by commissioning English HIV clinics to provide all vaccines.

Prior esophagogastroduodenoscopy does not affect the cecal intubation time at bidirectional endoscopies

PubMed Central

Öner, Osman Zekai; Demirci, Rojbin Karakoyun; Gündüz, Umut Rıza; Aslaner, Arif; Koç, Ümit; Bülbüller, Nurullah

2013-01-01

Bidirectional endoscopy (BE) is often used to assess patients for the reason of anemia or to screen asymptomatic population for malignancy. Limited clinical data favors to perform first the upper gastrointestinal system endoscopy, but its effect to the duration of colonoscopy is yet to be determined. The aim of this retrospective study is to evaluate the effect of upper gastrointestinal system endoscopy on the time to achieve cecal intubation during colonoscopy in patients undergoing BE. Patients of four endoscopists at similar experience levels were retrospectively identified and categorized into the upper gastrointestinal system endoscopy before colonoscopy group (group 1) or the colonoscopy only group (group 2). The demographics, clinical data and the time to achieve cecal intubation for each patient were analyzed. The mean time to achieve cecal intubation in the first group that included 319 cases was 8.4 ± 0.93 minutes and the mean time in the second group that included 1672 cases was 8.56 ± 1.16 minutes. There was no statistically significant difference between the groups. There was also no significant difference between the Group 1 and Group 2 when compared according to which of the four endoscopists performed the procedures. Performing the upper gastrointestinal system endoscopy prior to colonoscopy did not affect the time to achieve cecal intubation. Considering that performing the upper gastrointestinal system endoscopy prior to the colonoscopy is more advantageous in terms of patient comfort and analgesic requirement, beginning to BE with it seems more favorable. PMID:23936601

Optimal duration of ultra low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) therapy for muscular relaxation in neuromuscular occlusion: A preliminary clinical study.

PubMed

Esclassan, Rémi; Rumerio, Anaïs; Monsarrat, Paul; Combadazou, Jean Claude; Champion, Jean; Destruhaut, Florent; Ghrenassia, Christophe

2017-05-01

The primary aim of this work was to determine the duration of ultra-low-frequency transcutaneous electrical nerve stimulation (ULF-TENS) application necessary to achieve sufficient relaxation of the masticatory muscles. A secondary aim was to analyze the influence of stimulation on muscle relaxation in pathological subjects and determine whether ULF-TENS has a noteworthy impact on muscle relaxation. Sixteen adult subjects with temporomandibular disorders (TMD) and muscle pain and a group of four control subjects were included in this study. ULF-TENS was applied, and muscular activities of the masseter, temporal, and sternocleidomastoid muscles (SCM) were recorded for 60 min. Significant relaxation was achieved in the TMD group from 20, 40, and 60 min for the temporal, masseter, and SCM muscles (p < 0.05), respectively. Maximum relaxation was achieved in 12.5% of the subjects after 20 min, in a further 12.5% after 40 min, and in the remaining 75% after 60 min. Significant relaxation was achieved in the control group from 20 to 40 min for the masseter and temporal muscles, respectively (p < 0.05). Taken together, the results suggest that an ideal ULF-TENS application would last 40 min to obtain sufficient muscle relaxation both in patients with masticatory system disorders and healthy subjects, a time constraint that is consistent with everyday clinical practice.

Diabetes mellitus disease management in a safety net hospital system: translating evidence into practice.

PubMed

Butler, Michael K; Kaiser, Michael; Johnson, Jolene; Besse, Jay; Horswell, Ronald

2010-12-01

The Louisiana State University Health Care Services Division system assessed the effectiveness of implementing a multisite disease management program targeting diabetes mellitus in an indigent patient population. A population-based disease management program centered on evidence-based clinical care guidelines was applied from the system level. Specific clinic modifications and models were used, as well as ancillary services such as medication assistance and equipment subsidies. Marked improvement in process goals led to improved clinical outcomes. From 2001 to 2008, the percentage of patients with a hemoglobin A1c < 7.0 increased from 45% to 55% on the system level, with some sites experiencing a more dramatic shift. Results were similar across sites, which included both small provider groups and academic health centers. In order to achieve these results, the clinical environment changed to promote those evidence-based interventions. Even in complex environments such as academic health centers with several provider levels, or those environments with limited care resources, disease management programs can be successfully implemented and achieve statistically significant results.

HEMATOPOIETIC STEM CELL INFUSION/TRANSPLANTATION FOR INDUCTION OF ALLOGRAFT TOLERANCE

PubMed Central

Granados, Jose M. Marino; Benichou, Gilles; Kawai, Tatsuo

2015-01-01

Purpose of review This review updates the current status of basic, preclinical, and clinical research on donor hematopoietic stem cell infusion for allograft tolerance induction. Recent findings Recent basic studies in mice provide evidence of significant involvement of both central deletional and peripheral regulatory mechanisms in induction and maintenance of allograft tolerance effected through a mixed chimerism approach with donor hematopoietic stem cell infusion. The presence of heterologous memory T cells in primates hampers the induction of persistent chimerism. Durable mixed chimerism, however, now has been recently induced in inbred major histocompatibility complex-mismatched swine, resulting in tolerance of vascularized composite tissue allografts. In clinical transplantation, allograft tolerance has been achieved in human leukocyte antigen-mismatched kidney transplantation after the induction of transient mixed chimerism or persistent full donor chimerism. Summary Tolerance induction in clinical kidney transplantation has been achieved by donor hematopoietic stem cell infusion. Improving the consistency and safety of tolerance induction and extending successful protocols to other organs, as well as to organs from deceased donors, are critical next steps to bringing tolerance to a wider range of clinical applications. PMID:25563992

Nutritional Assessment: Its Significance in Medical Education.

ERIC Educational Resources Information Center

Ozerol, Nail H.

1982-01-01

Medical educators must make every effort to achieve an adequate level of nutrition education for all health professionals. Medical schools should adopt a basic, required curriculum including biochemical and physiological aspects of nutrients, a clinical nutrition program for prevention of health hazards, and a course in nutritional assessment.…

Consumer perspectives on involving family and significant others in a healthy lifestyle intervention.

PubMed

Aschbrenner, Kelly; Bartels, Stephen; Mueser, Kim; Carpenter-Song, Elizabeth; Kinney, Allison

2012-11-01

This focus group study explored the potential benefits and challenges of involving family members and significant others in a healthy lifestyle program for people with serious mental illness (SMI). Six focus group interviews were conducted with a total of 30 people with SMI, who were participants in a healthy lifestyle intervention. Separate focus groups were conducted for high and low achievers in the program based on clinically significant weight loss or significant increase in fitness. Thematic analysis revealed that social support for diet and exercise was a perceived benefit to involving others in a healthy lifestyle program. Other perceived benefits were the potential to increase others' understanding of the challenges of living with mental illness and to enhance the quality of relationships. Participants identified practical and logistical concerns that could interfere with participation, including partner reliability and desirability, scheduling, and lack of financial resources. Participants in the high achiever group expressed a greater desire to involve others in exercise than did participants in the low achiever group. Programs aimed at helping people with SMI make lifestyle changes may increase their effectiveness by involving significant others. Mobilizing social support networks for health behavior change is an ideal role for social workers.

Pre-hemorrhage statin use and the risk of vasospasm following aneurysmal subarachnoid hemorrhage

PubMed Central

Moskowitz, Shaye I.; Ahrens, Christine; Provencio, J Javier; Chow, Michael; Rasmussen, Peter A

2010-01-01

Background and Purpose Aneurysmal subarachnoid hemorrhage (SAH) is often followed by delayed ischemic deficits attributable to cerebral vasospasm. Recent studies suggest a positive impact of statin therapy on the incidence of vasospasm. This study was designed to assess whether a history of prior use of statin therapy was associated with a lower risk of vasospasm in patients with SAH. Methods We performed a comprehensive retrospective review of patients with aneurysmal SAH between 1997 and 2004. Clinical demographics and imaging data for all patients were reviewed and a logistic regression analysis was performed to identify the predictors of cerebral vasospasm, defined as a combination of clinical signs with radiographic confirmation. Results 308 patients were included. Mean age was higher in the group receiving statins (64 +/- 12 versus 54+/- 12 years). Hunt and Hess scores and treatment modality were not significantly different between the groups. Vasospasm was observed in 31% of patients not taking a statin (n=282) versus 23% taking a statin (n=26), without achieving statistical significance. Discontinuation of the statin did not affect risk of vasospasm. Conclusions Use of a statin prior to an aneurysmal SAH trended to reduce the incidence of subsequent vasospasm, without achieving statistical significance. PMID:18423529

Oxidative DNA Base Damage in MCF-10A Breast Epithelial Cells at Clinically Achievable Concentrations of Doxorubicin

PubMed Central

Gajewski, Ewa; Gaur, Shikha; Akman, Steven A.; Matsumoto, Linda; van Balgooy, Josephus N.A.; Doroshow, James H.

2009-01-01

The cellular metabolism of doxorubicin generates reactive oxygen species with significant potential to damage DNA. Such DNA damage can result in mutations if not adequately repaired by cellular DNA repair pathways. Secondary malignancies have been reported in patients who have received doxorubicin-containing chemotherapeutic regimens; however, the underlying molecular mechanism(s) to explain the development of these tumors remains under active investigation. We have previously demonstrated the presence of DNA bases modified by oxidation in the peripheral blood mononuclear cells of patients with breast cancer following treatment with doxorubicin. In those studies, doxorubicin was administered by continuous infusion over 96 hours to minimize the risk of cardiac toxicity. To evaluate potential mechanisms underlying doxorubicin-induced DNA base oxidation in non-malignant tissues, MCF-10A breast epithelial cells were cultured for 96 hours with the same doxorubicin concentration achieved in vivo (0.1 μM). During doxorubicin exposure, MCF-10A cells underwent growth arrest and apoptosis, developed elevated levels of reactive oxygen species, and demonstrated a time-dependent and significant increase in the levels of 11 oxidized DNA bases, as determined by gas chromatography/mass spectroscopy. Diminished expression of DNA repair enzymes was also observed over the same time course. Thus, clinically achievable concentrations of doxorubicin induce a level of oxidative stress in MCF-10A cells that is capable of oxidizing DNA bases and significantly altering cellular proliferation. PMID:17445777

Those Responsible for Approving Research Studies Have Poor Knowledge of Research Study Design: a Knowledge Assessment of Institutional Review Board Members.

PubMed

Mhaskar, Rahul; Pathak, Elizabeth Barnett; Wieten, Sarah; Guterbock, Thomas M; Kumar, Ambuj; Djulbegovic, Benjamin

2015-08-01

Institutional Review Board (IRB) members have a duty to protect the integrity of the research process, but little is known about their basic knowledge of clinical research study designs. A nationwide sample of IRB members from major US research universities completed a web-based questionnaire consisting of 11 questions focusing on basic knowledge about clinical research study designs. It included questions about randomized controlled trials (RCTs) and other observational research study designs. Potential predictors (age, gender, educational attainment, type of IRB, current IRB membership, years of IRB service, clinical research experience, and self-identification as a scientist) of incorrect answers were evaluated using multivariate logistic regression models. 148 individuals from 36 universities participated. The majority of participants, 68.9% (102/148), were holding a medical or doctoral degree. Overall, only 26.5% (39/148) of participants achieved a perfect score of 11. On the six-question subset addressing RCTs, 46.6% (69/148) had a perfect score. Most individual questions, and the summary model of overall quiz score (perfect vs. not perfect), revealed no significant predictors - indicating that knowledge deficits were not limited to specific subgroups of IRB members. For the RCT knowledge score there was one significant predictor: compared with MDs, IRB members without a doctoral degree were three times as likely to answer at least one RCT question incorrectly (Odds Ratio: 3.00, 95% CI 1.10-8.20). However, even among MD IRB members, 34.1% (14/41) did not achieve a perfect score on the six RCT questions. This first nationwide study of IRB member knowledge about clinical research study designs found significant knowledge deficits. Knowledge deficits were not limited to laypersons or community advocate members of IRBs, as previously suggested. Akin to widespread ethical training requirements for clinical researchers, IRB members should undergo systematic training on clinical research designs.

Self-Calibrating Wave-Encoded Variable-Density Single-Shot Fast Spin Echo Imaging.

PubMed

Chen, Feiyu; Taviani, Valentina; Tamir, Jonathan I; Cheng, Joseph Y; Zhang, Tao; Song, Qiong; Hargreaves, Brian A; Pauly, John M; Vasanawala, Shreyas S

2018-04-01

It is highly desirable in clinical abdominal MR scans to accelerate single-shot fast spin echo (SSFSE) imaging and reduce blurring due to T 2 decay and partial-Fourier acquisition. To develop and investigate the clinical feasibility of wave-encoded variable-density SSFSE imaging for improved image quality and scan time reduction. Prospective controlled clinical trial. With Institutional Review Board approval and informed consent, the proposed method was assessed on 20 consecutive adult patients (10 male, 10 female, range, 24-84 years). A wave-encoded variable-density SSFSE sequence was developed for clinical 3.0T abdominal scans to enable high acceleration (3.5×) with full-Fourier acquisitions by: 1) introducing wave encoding with self-refocusing gradient waveforms to improve acquisition efficiency; 2) developing self-calibrated estimation of wave-encoding point-spread function and coil sensitivity to improve motion robustness; and 3) incorporating a parallel imaging and compressed sensing reconstruction to reconstruct highly accelerated datasets. Image quality was compared pairwise with standard Cartesian acquisition independently and blindly by two radiologists on a scale from -2 to 2 for noise, contrast, confidence, sharpness, and artifacts. The average ratio of scan time between these two approaches was also compared. A Wilcoxon signed-rank tests with a P value under 0.05 considered statistically significant. Wave-encoded variable-density SSFSE significantly reduced the perceived noise level and improved the sharpness of the abdominal wall and the kidneys compared with standard acquisition (mean scores 0.8, 1.2, and 0.8, respectively, P < 0.003). No significant difference was observed in relation to other features (P = 0.11). An average of 21% decrease in scan time was achieved using the proposed method. Wave-encoded variable-density sampling SSFSE achieves improved image quality with clinically relevant echo time and reduced scan time, thus providing a fast and robust approach for clinical SSFSE imaging. 1 Technical Efficacy: Stage 6 J. Magn. Reson. Imaging 2018;47:954-966. © 2017 International Society for Magnetic Resonance in Medicine.

Variability in Clinical Integration Achieved by Athletic Training Students across Different Clinical Sport Assignments

ERIC Educational Resources Information Center

Dodge, Thomas M.; Mazerolle, Stephanie M.; Bowman, Thomas G.

2015-01-01

Context: Clinical integration impacts athletic training students' (ATSs) motivation and persistence. Research has yet to elucidate the manner in which different clinical placements can influence clinical integration. Objective: To examine differences in the levels of clinical integration achieved by ATSs across various clinical sport assignments.…

Indications of Recruitment Challenges in Research with U.S. Military Service Members: A ClinicalTrials.gov Review.

PubMed

Cook, Wendy A; Doorenbos, Ardith Z

2017-03-01

The success of military-relevant health research often depends on recruiting adequate numbers of U.S. military service members as research participants. Researchers have reported difficulties in recruiting service member research participants. Reviews of ClinicalTrials.gov, an online clinical trial registry of publicly and privately sponsored studies, have identified challenges in participant recruitment and barriers to study completion in various research populations. The purpose of this study was to identify indications of difficulty recruiting U.S. military service members as research participants based on data from study records in ClinicalTrials.gov. Records of studies starting between 2005 and 2014 were collected from ClinicalTrials.gov and updated through January 2016. Three hundred and two studies that included ≥25% U.S. military service member research participants were (1) compared to a comparison group of 302 studies, each with <5% service member participants and (2) compared by the proportion of service member participants within studies in the military group ("many" ≥25% but <100% service members and "all" 100% service members). Groups were evaluated and compared for recruitment status; reasons for study withdrawal, termination, or suspension; achievement of ≥85% of the anticipated enrollment; and differences in achieving recruitment goals according to study sponsor. Twelve percent of studies in the military group had been withdrawn, terminated, or suspended; enrollment and funding problems were the most common reasons. The comparison group had 11% of studies withdrawn, terminated, or suspended; the most common reasons were enrollment problems and sponsor decision. All study groups had indications of difficulty adequately achieving participant enrollment goals. Among studies with known anticipated and actual enrollment, approximately half in both the military group (47.9%) and comparison group (50.3%) achieved ≥85% of the anticipated enrollment (p = 0.722). Half of studies with many service members and 44% of studies with all service members achieved ≥85% of the anticipated enrollment (p = 0.600). In comparing the many and all service member subgroups, significant differences were found in the median values for anticipated enrollment and actual enrollment, even when accounting for Bonferroni correction. Evaluations of mean values did not show a statistical difference between the military subgroups. There were no significant differences according to study sponsor (military, academic, Veterans Affairs, National Institutes of Health, nonprofit organization, or industry) for a study achieving or not achieving ≥85% of the anticipated enrollment. This review supports anecdotal reports of difficulty recruiting service members as research participants. However, the findings also indicate that in many regards, there is not much difference in the difficulties recruiting service members versus other research participants. Findings suggest that it is often difficult to recruit research participants regardless of the specific population or type of study sponsor, and that studies with either many or all service member participants have similar achievement of recruitment goals. Findings in this study may be useful for those who design research that includes service members or for those who are apprehensive about including service members in their research. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

The internal audit of clinical areas: a pilot of the internal audit methodology in a health service emergency department.

PubMed

Brown, Alison; Santilli, Mario; Scott, Belinda

2015-12-01

Governing bodies of health services need assurance that major risks to achieving the health service objectives are being controlled. Currently, the main assurance mechanisms generated within the organization are through the review of implementation of policies and procedures and review of clinical audits and quality data. The governing bodies of health services need more robust, objective data to inform their understanding of the control of clinical risks. Internal audit provides a methodological framework that provides independent and objective assurance to the governing body on the control of significant risks. The article describes the pilot of the internal audit methodology in an emergency unit in a health service. An internal auditor was partnered with a clinical expert to assess the application of clinical criteria based on best practice guidelines. The pilot of the internal audit of a clinical area was successful in identifying significant clinical risks that required further management. The application of an internal audit methodology to a clinical area is a promising mechanism to gain robust assurance at the governance level regarding the management of significant clinical risks. This approach needs further exploration and trial in a range of health care settings. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

[Effectiveness of cognitive-behavioral therapy in childhood anxiety disorders in a university psychiatric outpatient clinic].

PubMed

Goletz, Hildegard; Yang, Young-Im; Suhr-Dachs, Lydia; Walter, Daniel; Döpfner, Manfred

2013-07-01

Only few studies have examined whether the efficacy of cognitive-behavioral therapy for childhood anxiety disorders as demonstrated in randomized controlled trials (RCTs) generalizes to clinical practice. This study examines the effectiveness of cognitive-behavioral therapy for juvenile anxiety disorders under routine care conditions in a university-based psychiatric outpatient clinic. 92 children and adolescents with parent-ratings regarding anxiety and comorbid symptoms and 61 children and adolescents with self-ratings regarding anxiety and comorbid symptoms were treated with cognitive-behavioral interventions. Pre/post mean comparisons, effect sizes, and the clinical significance of changes in symptoms were examined. The effect size for reduction of anxiety symptoms was .81 for children whose parents had completed the rating scale and .79 for children who had filled in a self-rating scale. Effect sizes for reduction of comorbid symptoms varied between .37 and .84 for parent ratings and between .21 and .62 for self-ratings. The percentage of children and adolescents who achieved clinically significant improvements in anxiety symptoms was 55.1 % according to the parent ratings and 65.7 % according to the children's self-ratings. More than 50 % of parents and children reported clinically significant improvements in comorbid symptoms. Significant reductions in both anxiety and comorbid symptoms were demonstrated over the course of cognitive-behavioral therapy of juvenile anxiety disorders in a university psychiatric outpatient clinic. The effect sizes for anxiety symptoms were found to be comparable to the effect sizes reported in RCTs. Similarly, clinically significant improvements were as frequent as the rates of remission of anxiety symptoms reported in RCTs.

Effects of moisture conditions of dental enamel surface on bond strength of brackets bonded with moisture-insensitive primer adhesive system.

PubMed

Endo, Toshiya; Ozoe, Rieko; Sanpei, Sugako; Shinkai, Koichi; Katoh, Yoshiroh; Shimooka, Shohachi

2008-07-01

The purposes of this study were to evaluate the effects of different degrees of water contamination on the shear bond strength of orthodontic brackets bonded to dental enamel with a moisture-insensitive primer (MIP) adhesive system and to compare the modes of bracket/adhesive failure. A total of 68 human premolars were divided into four groups by primers and enamel surface conditions (desiccated, blot dry, and overwet). In group I, the hydrophobic Transbond XT primer adhesive system was used under desiccated conditions for bonding the brackets; in group II, the hydrophilic Transbond MIP adhesive system was used under desiccated conditions; in group III, the hydrophilic Transbond MIP adhesive system was used under blot dry conditions; and in group IV, the hydrophilic Transbond MIP adhesive system was used under overwet conditions. Shear bond strength was measured with a universal testing machine, and the mode of bracket/adhesive failure was determined according to the adhesive remnant index. The mean shear bond strengths were not significantly different among groups I, II, and III, and were higher than the clinically required range of 6 to 8 MPa. The mean shear bond strength achieved in group IV was significantly lower than that achieved in groups I, II, and III, and also lower than the clinically required values. Bond failure occurred at the enamel-adhesive interface more frequently in group IV than in groups I and III. To achieve clinically sufficient bond strengths with the hydrophilic MIP adhesive system, excess water should be blotted from the water-contaminated enamel surface.

Modeling Pathologic Response of Esophageal Cancer to Chemoradiation Therapy Using Spatial-Temporal {sup 18}F-FDG PET Features, Clinical Parameters, and Demographics

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

Zhang, Hao; Tan, Shan; Department of Control Science and Engineering, Huazhong University of Science and Technology, Wuhan

2014-01-01

Purpose: To construct predictive models using comprehensive tumor features for the evaluation of tumor response to neoadjuvant chemoradiation therapy (CRT) in patients with esophageal cancer. Methods and Materials: This study included 20 patients who underwent trimodality therapy (CRT + surgery) and underwent {sup 18}F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) both before and after CRT. Four groups of tumor features were examined: (1) conventional PET/CT response measures (eg, standardized uptake value [SUV]{sub max}, tumor diameter); (2) clinical parameters (eg, TNM stage, histology) and demographics; (3) spatial-temporal PET features, which characterize tumor SUV intensity distribution, spatial patterns, geometry, and associated changesmore » resulting from CRT; and (4) all features combined. An optimal feature set was identified with recursive feature selection and cross-validations. Support vector machine (SVM) and logistic regression (LR) models were constructed for prediction of pathologic tumor response to CRT, cross-validations being used to avoid model overfitting. Prediction accuracy was assessed by area under the receiver operating characteristic curve (AUC), and precision was evaluated by confidence intervals (CIs) of AUC. Results: When applied to the 4 groups of tumor features, the LR model achieved AUCs (95% CI) of 0.57 (0.10), 0.73 (0.07), 0.90 (0.06), and 0.90 (0.06). The SVM model achieved AUCs (95% CI) of 0.56 (0.07), 0.60 (0.06), 0.94 (0.02), and 1.00 (no misclassifications). With the use of spatial-temporal PET features combined with conventional PET/CT measures and clinical parameters, the SVM model achieved very high accuracy (AUC 1.00) and precision (no misclassifications)—results that were significantly better than when conventional PET/CT measures or clinical parameters and demographics alone were used. For groups with many tumor features (groups 3 and 4), the SVM model achieved significantly higher accuracy than did the LR model. Conclusions: The SVM model that used all features including spatial-temporal PET features accurately and precisely predicted pathologic tumor response to CRT in esophageal cancer.« less

Effectiveness of polydeoxyribonucleotide injection versus normal saline injection for treatment of chronic plantar fasciitis: a prospective randomised clinical trial.

PubMed

Kim, Jae Kwang; Chung, Jae Yoon

2015-07-01

Polydeoxyribonucleotide (PDRN) has been used for the treatment of chronic tendinosis. This prospective randomised study was conducted to evaluate the efficacy and complications of PDRN injection for treatment of plantar fasciitis. Forty patients with a clinical diagnosis of plantar fasciitis were randomly allocated to PDRN injection (PDRN group, n = 20) or normal saline injection (placebo group, n = 20). Injections were performed weekly for three weeks. Clinical evaluations were done at baseline and four and 12 weeks after treatment began using the visual analogue scale (VAS) for foot pain and Manchester-Oxford Foot Questionnaire (MOXFQ). We also monitored the complications in both groups at one, two, four and 12 weeks after initial treatment. The PDRN group achieved a significant improvement in VAS and MOXFQ scores at four weeks after treatment, and this improvement continued until 12 weeks after treatment. On the other hand, the placebo group did not achieve a significant improvement in the VAS or MOXFQ scores at four or 12 weeks. The initial VAS and MOXFQ scores of the PDRN group were not significantly different from those of the placebo group. At four weeks after treatment, the VAS and MOXFQ scores of the PDRN group were better than those of the placebo group, but the difference was not statistically significant. At 12 weeks after treatment, the VAS and MOXFQ scores of the PDRN group were significantly better than those of the placebo group. We noticed no injection-related complications, such as itching, urticaria, redness or infection signs around the injection site in either group. PDRN injection is an effective and safe treatment option and may be considered for plantar fasciitis.

Predictive Factor Analysis of Response-Adapted Radiation Therapy for Chemotherapy-Sensitive Pediatric Hodgkin Lymphoma: Analysis of the Children's Oncology Group AHOD 0031 Trial

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

Charpentier, Anne-Marie; Friedman, Debra L.; Wolden, Suzanne

Purpose: To evaluate whether clinical risk factors could further distinguish children with intermediate-risk Hodgkin lymphoma (HL) with rapid early and complete anatomic response (RER/CR) who benefit significantly from involved-field RT (IFRT) from those who do not, and thereby aid refinement of treatment selection. Methods and Materials: Children with intermediate-risk HL treated on the Children's Oncology Group AHOD 0031 trial who achieved RER/CR with 4 cycles of chemotherapy, and who were randomized to 21-Gy IFRT or no additional therapy (n=716) were the subject of this study. Recursive partitioning analysis was used to identify factors associated with clinically and statistically significant improvement inmore » event-free survival (EFS) after randomization to IFRT. Bootstrap sampling was used to evaluate the robustness of the findings. Result: Although most RER/CR patients did not benefit significantly from IFRT, those with a combination of anemia and bulky limited-stage disease (n=190) had significantly better 4-year EFS with the addition of IFRT (89.3% vs 77.9% without IFRT; P=.019); this benefit was consistently reproduced in bootstrap analyses and after adjusting for other prognostic factors. Conclusion: Although most patients achieving RER/CR had favorable outcomes with 4 cycles of chemotherapy alone, those children with initial bulky stage I/II disease and anemia had significantly better EFS with the addition of IFRT as part of combined-modality therapy. Further work evaluating the interaction of clinical and biologic factors and imaging response is needed to further optimize and refine treatment selection.« less

Minimal Clinically Important Difference and Substantial Clinical Benefit After Revision Hip Arthroscopy.

PubMed

Nwachukwu, Benedict U; Chang, Brenda; Rotter, Ben-Zion; Kelly, Bryan T; Ranawat, Anil S; Nawabi, Danyal H

2018-06-01

To define minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in revision hip arthroscopy. The modified Harris Hip Score (mHHS), the Hip Outcome Score (HOS), and the international Hip Outcome Tool (iHOT-33) were administered to revision hip arthroscopy patients. At 1 year postoperatively, patients graded their hip function based on anchor responses. SCB was defined as both a net change and an absolute value. Receiver operating characteristic analysis with area under the curve was used to confirm psychometric values. A distribution-based method was used for MCID. Forty-nine patients were included with a mean age of 29.7 (±8.6) years. The most common indication for revision hip arthroscopy was residual femoroacetabular impingement (FAI; N = 34; 69.4%) followed by capsular management (N = 8; 16.3%). At 1-year follow-up, 34 patients reported feeling improved. Outcome score change corresponding to MCID and SCB net change for the mHHS, HOS Activities of Daily Living (ADL), HOS Sports, and iHOT-33 was 7.9/23.1, 7.9/16.2, 13.1/25.0, and 12.8/25.5, respectively. A higher proportion of patients with residual FAI achieved MCID compared with patients with other diagnoses. On the preoperative HOS ADL, HOS Sports, and iHOT-33, patients scoring below 67.7 (0.78), 55.6 (0.81), and 35.7 (0.73) were significantly more likely to achieve SCB postoperatively. Thirty-four patients (73.9%) were classified as receiving physical function improvement, and on the HOS Sports, MCID was achieved by 65% whereas 43% met the SCB criteria. MCID values ranged from 7.9 on the mHHS and the HOS ADL to 13.1 on the HOS Sports. SCB net change ranged from 16.2 on the HOS ADL to 25.2 on the iHOT-33, whereas absolute SCB ranged from 82.4 on the iHOT-33 to 84.7 on the mHHS. Residual FAI and capsular management were the most common indications for revision surgery with patients who underwent surgery for the former found to be most likely to achieve clinically significant improvement. Level IV, case series. Copyright © 2018 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

The effect of partially exposed connective tissue graft on root-coverage outcomes: a systematic review and meta-analysis.

PubMed

Dodge, Austin; Garcia, Jeffrey; Luepke, Paul; Lai, Yu-Lin; Kassab, Moawia; Lin, Guo-Hao

2018-04-01

The aim of this systematic review was to compare the root-coverage outcomes of using a partially exposed connective tissue graft (CTG) technique with a fully covered CTG technique for root coverage. An electronic search up to February 28 th , 2017, was performed to identify human clinical studies with data comparing outcomes of root coverage using CTG, with and without a partially exposed graft. Five clinical studies were selected for inclusion in this review. For each study, the gain of keratinized gingiva, reduction of recession depth, number of surgical sites achieving complete root coverage, percentage of root coverage, gain of tissue thickness, and changes of probing depth and clinical attachment level were recorded. Meta-analysis for the comparison of complete root coverage between the two techniques presented no statistically significant differences. A statistically significant gain of keratinized tissue in favor of the sites with an exposed CTG and a tendency of greater reduction in recession depth were seen at the sites with a fully covered CTG. Based on the results, the use of a partially exposed CTG in root-coverage procedures could achieve greater gain in keratinized gingiva, while a fully covered CTG might be indicated for procedures aiming to reduce recession depth. © 2018 Eur J Oral Sci.

Assessment of PlanIQ Feasibility DVH for head and neck treatment planning.

PubMed

Fried, David V; Chera, Bhishamjit S; Das, Shiva K

2017-09-01

Designing a radiation plan that optimally delivers both target coverage and normal tissue sparing is challenging. There are limited tools to determine what is dosimetrically achievable and frequently the experience of the planner/physician is relied upon to make these determinations. PlanIQ software provides a tool that uses target and organ at risk (OAR) geometry to indicate the difficulty of achieving different points for organ dose-volume histograms (DVH). We hypothesized that PlanIQ Feasibility DVH may aid planners in reducing dose to OARs. Clinically delivered head and neck treatments (clinical plan) were re-planned (re-plan) putting high emphasis on maximally sparing the contralateral parotid gland, contralateral submandibular gland, and larynx while maintaining routine clinical dosimetric objectives. The planner was blinded to the results of the clinically delivered plan as well as the Feasibility DVHs from PlanIQ. The re-plan treatments were designed using 3-arc VMAT in Raystation (RaySearch Laboratories, Sweden). The planner was then given the results from the PlanIQ Feasibility DVH analysis and developed an additional plan incorporating this information using 4-arc VMAT (IQ plan). The DVHs across the three treatment plans were compared with what was deemed "impossible" by PlanIQ's Feasibility DVH (Impossible DVH). The impossible DVH (red) is defined as the DVH generated using the minimal dose that any voxel outside the targets must receive given 100% target coverage. The re-plans performed blinded to PlanIQ Feasibilty DVH achieved superior sparing of aforementioned OARs compared to the clinically delivered plans and resulted in discrepancies from the impossible DVHs by an average of 200-700 cGy. Using the PlanIQ Feasibility DVH led to additionalOAR sparing compared to both the re-plans and clinical plans and reduced the discrepancies from the impossible DVHs to an average of approximately 100 cGy. The dose reduction from clinical to re-plan and re-plan to IQ plan were significantly different even when taking into account multiple hypothesis testing for both the contralateral parotid and the larynx (P < 0.004 for all comparisons). No significant differences were observed between the three plans for the contralateral parotid when considering multiple hypothesis testing. Clinical treatment plans and blinded re-plans were found to suboptimally spare OARs. PlanIQ could aid planners in generating treatment plans that push the limits of OAR sparing while maintaining routine clinical target coverage goals. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

The potential of targeting Ras proteins in lung cancer.

PubMed

McCormick, Frank

2015-04-01

The Ras pathway is a major driver in lung adenocarcinoma: over 75% of all cases harbor mutations that activate this pathway. While spectacular clinical successes have been achieved by targeting activated receptor tyrosine kinases in this pathway, little, if any, significant progress has been achieved targeting Ras proteins themselves or cancers driven by oncogenic Ras mutants. New approaches to drug discovery, new insights into Ras function, new ways of attacking undruggable proteins through RNA interference and new ways of harnessing the immune system could change this landscape in the relatively near future.

GeneCount: genome-wide calculation of absolute tumor DNA copy numbers from array comparative genomic hybridization data

PubMed Central

Lyng, Heidi; Lando, Malin; Brøvig, Runar S; Svendsrud, Debbie H; Johansen, Morten; Galteland, Eivind; Brustugun, Odd T; Meza-Zepeda, Leonardo A; Myklebost, Ola; Kristensen, Gunnar B; Hovig, Eivind; Stokke, Trond

2008-01-01

Absolute tumor DNA copy numbers can currently be achieved only on a single gene basis by using fluorescence in situ hybridization (FISH). We present GeneCount, a method for genome-wide calculation of absolute copy numbers from clinical array comparative genomic hybridization data. The tumor cell fraction is reliably estimated in the model. Data consistent with FISH results are achieved. We demonstrate significant improvements over existing methods for exploring gene dosages and intratumor copy number heterogeneity in cancers. PMID:18500990

Continuity Clinic Model and Diabetic Outcomes in Internal Medicine Residencies: Findings of the Educational Innovations Project Ambulatory Collaborative

PubMed Central

Francis, Maureen D.; Julian, Katherine A.; Wininger, David A.; Drake, Sean; Bollman, KeriLyn; Nabors, Christopher; Pereira, Anne; Rosenblum, Michael; Zelenski, Amy B.; Sweet, David; Thomas, Kris; Varney, Andrew; Warm, Eric; Francis, Mark L.

2016-01-01

Background Efforts to improve diabetes care in residency programs are ongoing and in the midst of continuity clinic redesign at many institutions. While there appears to be a link between resident continuity and improvement in glycemic control for diabetic patients, it is uncertain whether clinic structure affects quality measures and patient outcomes. Methods This multi-institutional, cross-sectional study included 12 internal medicine programs. Three outcomes (glycemic control, blood pressure control, and achievement of target low-density lipoprotein [LDL]) and 2 process measures (A1C and LDL measurement) were reported for diabetic patients. Traditional, block, and combination clinic models were compared using analysis of covariance (ANCOVA). Analysis was adjusted for continuity, utilization, workload, and panel size. Results No significant differences were found in glycemic control across clinic models (P = .06). The percentage of diabetic patients with LDL < 100 mg/dL was 60% in block, compared to 54.9% and 55% in traditional and combination models (P = .006). The percentage of diabetic patients with blood pressure < 130/80 mmHg was 48.4% in block, compared to 36.7% and 36.9% in other models (P < .001). The percentage of diabetic patients with HbA1C measured was 92.1% in block compared to 75.2% and 82.1% in other models (P < .001). Also, the percentage of diabetic patients with LDL measured was significantly different across all groups, with 91.2% in traditional, 70.4% in combination, and 83.3% in block model programs (P < .001). Conclusions While high scores on diabetic quality measures are achievable in any clinic model, the block model design was associated with better performance. PMID:26913099

A Multidisciplinary Clinical Program is Effective in Stabilizing BMI and Reducing Transaminase Levels in Pediatric Patients with NAFLD

PubMed Central

DeVore, Stephanie; Kohli, Rohit; Lake, Kathleen; Nicholas, Lynda; Dietrich, Kim; Balistreri, William F.; Xanthakos, Stavra A.

2013-01-01

Weight loss is an effective treatment for children with non-alcoholic fatty liver disease (NAFLD) but it is very difficult to achieve outside of an intensive weight management program. We hypothesized that one can achieve success in improving NAFLD and weight-related outcomes in a structured and focused multidisciplinary clinical program feasible to implement in a gastroenterology clinic. Methods We prospectively tracked the clinical status of our patients enrolled in a multidisciplinary program of dietary and exercise advice through an Institutional Review Board-approved NAFLD registry. Each patient met with a gastroenterologist and dietician every 3 months for 30 minutes to set individualized goals and monitor progress. Results 108 children have been enrolled in the registry and of the 83 that were eligible for 1 year follow-up and included in the analysis, 39 patients returned, resulting in a 47% follow-up rate. These 39 patients showed statistically significant improvements in mean BMI z-score (−0.1 units, p<0.05), total (−11 mg/dL, p<0.05) and low density lipoprotein cholesterol (−9 mg/dL, p<0.05), and serum alanine aminotransferase (ALT) levels (−36 U/L) and aspartate amino transferase (AST) levels (−22 U/L) levels. Conclusion A clinically feasible multidisciplinary program of every 3 month 30 minute visits to set and monitor nutrition and exercise goals, stabilized mean BMI z-score and significantly improved aminotransferase levels at 1 year follow-up in obese pediatric patients with NAFLD. PMID:23518484

Relating children's attentional capabilities to intelligence, memory, and academic achievement: a test of construct specificity in children with asthma.

PubMed

Annett, Robert D; Bender, Bruce G; Gordon, Michael

2007-01-01

The relationship between attention, intelligence, memory, achievement, and behavior in a large population (N = 939) of children without neuropsychologic problems was investigated in children with mild and moderate asthma. It was hypothesized that different levels of children's attentional capabilities would be associated with different levels of intellectual, memory, and academic abilities. Children ages 6-12 at the eight clinical centers of the Childhood Asthma Management Program (CAMP) were enrolled in this study. Standardized measures of child neuropsychological and behavioral performance were administered to all participants, with analyses examining both the developmental trajectory of child attentional capabilities and the associations between Continuous Performance Test (CPT) scores and intellectual functioning, and measures of memory, academic achievement, and behavioral functioning. Findings demonstrated that correct responses on the CPT increase significantly with age, while commission errors decrease significantly with age. Performance levels on the CPT were associated with differences in child intellectual function, memory, and academic achievement. Overall these findings reveal how impairments in child attention skills were associated with normal levels of performance on measures of children's intelligence, memory, academic achievement, and behavioral functioning, suggesting that CPT performance is a salient marker of brain function.

Improving efficiency and saving money in an otolaryngology urgent referral clinic.

PubMed

Ibrahim, Nader; Virk, Jagdeep; George, Jason; Elmiyeh, Behrad; Singh, Arvind

2015-06-16

A closed loop audit of the ear nose and throat (ENT) urgent referral clinic at a London hospital was conducted assessing the number of patients reviewed, referral source, appropriateness of referral, presenting complaint and assigned follow-up appointments. Data was sourced from clinic letters and the patient appointment system over a 3-mo period. The initial cycle analysed 490 patients and the subsequent cycle 396. The initial audit yielded clinically relevant and cost effective recommendations which were implemented, and the audit cycle was subsequently repeated. The re-audit demonstrated decreased clinic numbers from an average 9.8 to 7.2 patients per clinic, in keeping with ENT United Kingdom guidelines. A 21% decrease in patient follow-up and 13% decrease in inappropriate referrals was achieved. Direct bookings into outpatient clinics decreased by 8%, due to correct referral pathway utilisation. Comparisons of all data sets were found to show statistical significance P < 0.05. We reported a total financial saving of £32490 in a period of 3 mo (£590 per clinic). We demonstrated that simple guidelines, supervision and consultant-led education which are non-labour intensive can have a significant impact on service provision and cost.

The effect of human sperm chromatin maturity on ICSI outcomes.

PubMed

Gill, Kamil; Rosiak, Aleksandra; Gaczarzewicz, Dariusz; Jakubik, Joanna; Kurzawa, Rafal; Kazienko, Anna; Rymaszewska, Anna; Laszczynska, Maria; Grochans, Elzbieta; Piasecka, Malgorzata

2018-03-29

Because sperm chromatin may play a key role in reproductive success, we verify the associations between sperm chromatin abnormalities, embryo development and the ability to achieve pregnancy. The evaluation of sperm chromatin maturity using aniline blue (AB), chromomycin A3 (CMA3) and toluidine blue (TB) staining were carried out in group of males from infertile couples that underwent ICSI. Low levels of sperm chromatin abnormalities (< 16%) were found in most subjects (> 50%). A higher percentage of TB-positive sperm cells were discovered in the men from couples who achieved ≤ 50% fertilized oocytes compared to men who achieved > 50%. No significant differences were discovered by the applied tests between the men from couples who achieved ≤ 50% and those who achieved > 50% high-quality embryos on the 3rd or 5th day after fertilization, nor between the men from couples who achieved pregnancy and those who failed. The sperm chromatin maturity did not correlate with the ICSI results. However, the ROC analysis revealed a significant predictive value of TB-positive spermatozoa only for fertilization. Therefore, the TB assay can be considered as a useful test for the prediction of fertilization. Our findings suggest that the level of sperm chromatin abnormalities of the examined men was not clinically significant. No found associations between sperm chromatin maturity and embryo development and the ability to achieve pregnancy. We could not exclude the effects of the repairing processes in the fertilized oocyte. The use of complementary tests that verify the status of the sperm chromatin seems justified.

Health coaching by medical assistants to improve control of diabetes, hypertension, and hyperlipidemia in low-income patients: a randomized controlled trial.

PubMed

Willard-Grace, Rachel; Chen, Ellen H; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Thom, David H

2015-03-01

Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ(2) tests and linear regression models. Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly. Medical assistants serving as in-clinic health coaches improved control of hemoglobin A1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients' clinical conditions, interventions, and the contextual features of implementation. © 2015 Annals of Family Medicine, Inc.

Health Coaching by Medical Assistants to Improve Control of Diabetes, Hypertension, and Hyperlipidemia in Low-Income Patients: A Randomized Controlled Trial

PubMed Central

Willard-Grace, Rachel; Chen, Ellen H.; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Thom, David H.

2015-01-01

PURPOSE Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. METHODS We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ2 tests and linear regression models. RESULTS Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly. CONCLUSIONS Medical assistants serving as in-clinic health coaches improved control of hemoglobin A1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients’ clinical conditions, interventions, and the contextual features of implementation. PMID:25755034

Treatment and therapeutic monitoring of canine hypothyroidism.

PubMed

Dixon, R M; Reid, S W J; Mooney, C T

2002-08-01

Thirty-one dogs with spontaneous hypothyroidism were treated with thyroid hormone replacement therapy (THRT) and monitored for approximately three months. Good clinical and laboratory control was ultimately achieved in all cases with a mean L-thyroxine (T4) dose of 0.026 mg/kg administered once daily. There was a significant increase and decrease in circulating total T4 and canine thyroid stimulating hormone (cTSH) concentrations, respectively, after starting THRT. After commencing treatment, 11 cases subsequently required an increase and three cases required a decrease in dose to achieve optimal clinical control. Median (semi interquartile range [SIR]) circulating six-hour post-pill total T4 (53.6 [27.91 nmol/litre) and cTSH (0.03 [0] microg/litre) concentrations were significantly increased and decreased, respectively, in treated dogs that did not require a dose change; corresponding values in treated dogs in which an increase in dose was required were 29.3 (12.7) nmol/litre and 0.15 (0.62) microg/litre, respectively. However, circulating cTSH measurement was of limited value in assessing therapeutic control because, although increased values were associated with inadequate therapy, reference range cTSH values were common in inadequately treated dogs. Lethargy and mental demeanour were typically the first clinical signs to improve, with significant bodyweight reduction occurring within two weeks of commencing THRT. Routine clinicopathological monitoring was of value in confirming a general metabolic response to THRT, but was of limited value in accurately monitoring cases or tailoring therapy in individual cases.

Beyond Necrotizing Enterocolitis: Other Clinical Advantages of an Exclusive Human Milk Diet.

PubMed

Hair, Amy B; Rechtman, David J; Lee, Martin L; Niklas, Victoria

2018-06-07

Articles previously published by Sullivan et al. and Cristofalo et al. were reanalyzed using the proportion of cow milk-based nutrition received to determine whether that affected clinical outcomes during hospitalization for infants birth weight 500-1250 g. Abrams et al. showed in the same cohort incidences of necrotizing enterocolitis (NEC), NEC requiring surgery and sepsis increased proportionally to the amount of dietary cow milk. The data from the two studies conducted under essentially the same protocol were combined yielding a cohort of 260 infants receiving a diet ranging from 0% to 100% cow milk. Data analysis utilized negative binomial regression which mitigates differences between subjects in terms of their time on study by incorporating that number into the statistical model. The percent of cow milk-based nutrition was the only predictor investigated. For all outcomes the larger the amount of cow's milk in the diet the greater the number of days of that intervention required. A trend toward statistical significance was seen for ventilator days; however, only parenteral nutrition (PN) days and days to full feeds achieved statistical significance. Incorporation of any cow milk-based nutrition into the diet of extremely premature infants correlates with more days on PN and a longer time to achieve full feeds. There was a nonstatistically significant trend toward increased ventilator days. These represent additional clinical consequences of the use of any cow milk-based protein in feeding EP infants.

Evaluation of a clinical TOF-PET detector design that achieves ⩽100 ps coincidence time resolution.

PubMed

Cates, Joshua W; Levin, Craig S

2018-06-07

Commercially available clinical positron emission tomography (PET) detectors employ scintillation crystals that are long ([Formula: see text]20 mm length) and narrow (4-5 mm width) optically coupled on their narrow end to a photosensor. The aspect ratio of this traditional crystal rod configuration and 511 keV photon attenuation properties yield significant variances in scintillation light collection efficiency and transit time to the photodetector, due to variations in the 511 keV photon interaction depth in the crystal. These variances contribute significant to coincidence time resolution degradation. If instead, crystals are coupled to a photosensor on their long side, near-complete light collection efficiency can be achieved, and scintillation photon transit time jitter is reduced. In this work, we compare the achievable coincidence time resolution (CTR) of LGSO:Ce(0.025 mol%) crystals 3-20 mm in length when optically coupled to silicon photomultipliers (SiPMs) on either their short end or long side face. In this 'side readout' configuration, a CTR of 102  ±  2 ps FWHM was measured with [Formula: see text] mm 3 crystals coupled to rows of [Formula: see text] mm 2 SensL-J SiPMs using leading edge time pickoff and a single timing channel. This is in contrast to a CTR of 137  ±  3 ps FWHM when the same crystals were coupled to single [Formula: see text] mm 2 SiPMs on their narrow ends. We further study the statistical limit on CTR using side readout via the Cramér-Rao lower bound (CRLB), with consideration given to ongoing work to further improve photosensor technologies and exploit fast phenomena to ultimately achieve 10 ps FWHM CTR. Potential design aspects of scalable front-end signal processing readout electronics using this side readout configuration are discussed. Altogether, we demonstrate that the side readout configuration offers an immediate solution for 100 ps CTR clinical PET detectors and mitigates factors prohibiting future efforts to achieve 10 ps FWHM CTR.

The retrieval of unerupted teeth in pedodontics: two case reports

PubMed Central

2014-01-01

Introduction The retrieval of unerupted teeth in pedodontics is always significant to preserve the trophism of adjacent tissues, establish the correct space, provide adequate function and maintain good esthetics for the patient. The treatment plan is based on radiographic examinations and measurements, and on an accurate clinical evaluation; it aims to achieve the best treatment possible depending on the complexity of the specific case. In the most difficult clinical cases it is very important to have an early diagnosis, which is essential to plan the treatment and achieve success. In these cases, the pediatrician is in a strategic position to give an early diagnosis through a child’s medical history and by counting the child’s teeth. Case presentation This article presents two different difficult clinical cases of impacted teeth diagnosed during pediatric age, with a radiological analysis, and successfully treated with orthodontic devices designed for these specific cases. Clinical case 1 describes a 13-year-old Italian girl; clinical case 2 describes a 9-year-old Italian girl. The use of these devices achieved the desired treatment goals. The problems associated with impacted teeth and the biomechanical interventions used for these patients are discussed. Conclusions An early and careful diagnosis followed by an accurate treatment plan for the individual cases can lead to retrieval of the impacted teeth without affecting other anatomic structures and adjacent teeth. In these cases, the pediatrician is in a strategic position to give an early diagnosis through a child’s medical history and by counting the child’s teeth. PMID:25301242

Anesthetic Efficacy of Meperidine in Teeth With Symptomatic Irreversible Pulpitis

PubMed Central

Mohajeri, Ladan; Salehi, Farnaz; Mehrvarzfar, Payman; Arfaee, Hamide; Bohluli, Behnam; Hamedy, Reza

2015-01-01

Achieving adequate pulpal anesthesia in mandibular teeth is always a challenge. Supplementary injections and using drugs in combination are some methods implemented to overcome this hurdle. In this randomized clinical trial, use of meperidine in conjunction with lidocaine in intraligamentary injection did not exhibit significant improvement in anesthesia. PMID:25849469

The antiviral effects of RSV fusion inhibitor, MDT-637, on clinical isolates, vs its achievable concentrations in the human respiratory tract and comparison to ribavirin.

PubMed

Kim, Young-In; Pareek, Rajat; Murphy, Ryan; Harrison, Lisa; Farrell, Eric; Cook, Robert; DeVincenzo, John

2017-11-01

Respiratory syncytial virus (RSV) viral load and disease severity associate, and the timing of viral load and disease run in parallel. An antiviral must be broadly effective against the natural spectrum of RSV genotypes and must attain concentrations capable of inhibiting viral replication within the human respiratory tract. We evaluated a novel RSV fusion inhibitor, MDT-637, and compared it with ribavirin for therapeutic effect in vitro to identify relative therapeutic doses achievable in humans. MDT-637 and ribavirin were co-incubated with RSV in HEp-2 cells. Quantitative PCR assessed viral concentrations; 50% inhibitory concentrations (IC 50 ) were compared to achievable human MDT-637 and ribavirin peak and trough concentrations. The IC 50 for MDT-637 and ribavirin (against RSV-A Long) was 1.42 and 16 973 ng/mL, respectively. The ratio of achievable peak respiratory secretion concentration to IC 50 was 6041-fold for MDT-637 and 25-fold for aerosolized ribavirin. The ratio of trough concentration to IC 50 was 1481-fold for MDT-637 and 3.29-fold for aerosolized ribavirin. Maximal peak and trough levels of oral or intravenous ribavirin were significantly lower than their IC 50 s. We also measured MDT-637 IC 50 s in 3 lab strains and 4 clinical strains. The IC 50 s ranged from 0.36 to 3.4 ng/mL. Achievable human MDT-637 concentrations in respiratory secretions exceed the IC 50 s by factors from hundreds to thousands of times greater than does ribavirin. Furthermore, MDT-637 has broad in vitro antiviral activity on clinical strains of different RSV genotypes and clades. Together, these data imply that MDT-637 may produce a superior clinical effect compared to ribavirin on natural RSV infections. © 2017 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Metronomic chemotherapy against cancer: from paradigm to clinical practice?

PubMed

Calvani, Nicola; Orlando, Laura; Nacci, Angelo; Sponziello, Francesco; Cinefra, Margherita; Cinieri, Saverio

2009-01-01

We describe two paradigmatic cases where metronomic antitumor chemotherapy was successfully employed in patients not suitable for standard treatments. The first patient was affected by advanced soft tissue sarcoma but she also had ischemic cardiopathy. She received oral cyclophosphamide 50 mg once daily and methotrexate 2.5 mg bid twice weekly, obtaining a significant clinical response with a progression-free survival of 7 months. The second patient was over 70 years of age and suffered from metastatic gastric cancer. Because of his poor performance status he was given capecitabine 1500 mg daily, achieving a complete remission with a current disease-free survival of 13 months. In both cases no significant toxicities were observed.

Consecutive monitoring of faecal calprotectin during mesalazine suppository therapy for active rectal inflammation in ulcerative colitis.

PubMed

Yamamoto, T; Shimoyama, T; Matsumoto, K

2015-09-01

No studies have monitored the levels of faecal calprotectin (FC) during mesalazine suppository therapy for proctitis in ulcerative colitis (UC). To evaluate the value of consecutive monitoring of FC in patients with UC during mesalazine suppository therapy. One hundred and sixty patients with active inflammation limited to the rectum were treated with mesalazine 1 g suppository once daily for 8 weeks. Patients who achieved clinical remission were advised to maintain the treatment, and were followed up for further 40 weeks. FC levels were measured every 8 weeks during the study. At week 8, 118 patients (74%) went into clinical remission, of whom 88 achieved endoscopic healing. The median FC level significantly decreased in patients with clinical and endoscopic remission (both P < 0.0001), while it did not change significantly in those without remission. Eighty (68%) of the 118 patients with remission continued the treatment. Twenty-four patients (30%) relapsed during the 40-week follow-up. In patients with clinical relapse, the median FC level elevated already 8 weeks before the diagnosis of relapse. In contrast, in patients who maintained remission it remained at a low level and did not significantly change during the follow-up. Elevated FC level (≥55 μg/g) was useful for the early diagnosis of relapse (88% sensitivity and 80% specificity). Faecal calprotectin may represent a useful biomarker for the assessment of disease activity in UC patients treated with mesalazine suppositories. Serial monitoring of faecal calprotectin appears to be valuable for the prediction and early diagnosis of relapse during maintenance therapy. © 2015 John Wiley & Sons Ltd.

Assessment of Diastolic Function in Single Ventricle Patients Following the Fontan Procedure

PubMed Central

Margossian, Renee; Sleeper, Lynn A.; Pearson, Gail D.; Barker, Piers C.; Mertens, Luc; Quartermain, Michael D.; Su, Jason T.; Shirali, Girish; Chen, Shan; Colan, Steven D.

2016-01-01

Objectives Patients with functional single ventricles (FSV) following the Fontan procedure have abnormal cardiac mechanics. We sought to determine factors that influence diastolic function and to describe associations of diastolic function with current clinical status. Methods Echocardiograms were obtained as part of the Pediatric Heart Network Fontan Cross-Sectional Study. Diastolic function grade (DFG) was assessed as normal (grade 0), impaired relaxation (grade 1), pseudonormalization (grade 2), restrictive (grade 3). Studies were also classified dichotomously (restrictive pattern present or absent). Relationships between DFG and pre-Fontan variables (e.g., ventricular morphology, age at Fontan, history of volume-unloading surgery), and current status (e.g., systolic function, valvar regurgitation, exercise performance) were explored. Results DFG was calculable in 326/546 subjects (60%); mean age = 11.7±3.3 years. Overall, 32% of patients had grade 0, 9% grade 1, 37% grade 2, and 22% grade 3. Although there was no association between ventricular morphology and DFG, there was an association between ventricular morphology and E’, which was lowest in those with right ventricular morphology (p<.001); this association remained significant when using z-scores adjusted for age (p=<.001). DFG was associated with achieving maximal effort on exercise testing (p=.004); the majority (64%) of those not achieving maximal effort had DFG 2 or 3.No additional significant associations of DFG with laboratory or clinical measures were identified. Conclusion Assessment of diastolic function by current algorithms results in a high percentage of patients with abnormal DFG, but we found few clinically or statistically significant associations. This may imply a lack of impact of abnormal diastolic function upon clinical outcome in this cohort, or may indicate that the methodology may not be applicable to pediatric FSV patients. PMID:27624592

Problem-based learning using patient-simulated videos showing daily life for a comprehensive clinical approach

PubMed Central

Ohira, Yoshiyuki; Uehara, Takanori; Noda, Kazutaka; Suzuki, Shingo; Shikino, Kiyoshi; Kajiwara, Hideki; Kondo, Takeshi; Hirota, Yusuke; Ikusaka, Masatomi

2017-01-01

Objectives We examined whether problem-based learning tutorials using patient-simulated videos showing daily life are more practical for clinical learning, compared with traditional paper-based problem-based learning, for the consideration rate of psychosocial issues and the recall rate for experienced learning. Methods Twenty-two groups with 120 fifth-year students were each assigned paper-based problem-based learning and video-based problem-based learning using patient-simulated videos. We compared target achievement rates in questionnaires using the Wilcoxon signed-rank test and discussion contents diversity using the Mann-Whitney U test. A follow-up survey used a chi-square test to measure students’ recall of cases in three categories: video, paper, and non-experienced. Results Video-based problem-based learning displayed significantly higher achievement rates for imagining authentic patients (p=0.001), incorporating a comprehensive approach including psychosocial aspects (p<0.001), and satisfaction with sessions (p=0.001). No significant differences existed in the discussion contents diversity regarding the International Classification of Primary Care Second Edition codes and chapter types or in the rate of psychological codes. In a follow-up survey comparing video and paper groups to non-experienced groups, the rates were higher for video (χ2=24.319, p<0.001) and paper (χ2=11.134, p=0.001). Although the video rate tended to be higher than the paper rate, no significant difference was found between the two. Conclusions Patient-simulated videos showing daily life facilitate imagining true patients and support a comprehensive approach that fosters better memory. The clinical patient-simulated video method is more practical and clinical problem-based tutorials can be implemented if we create patient-simulated videos for each symptom as teaching materials.  PMID:28245193

Problem-based learning using patient-simulated videos showing daily life for a comprehensive clinical approach.

PubMed

Ikegami, Akiko; Ohira, Yoshiyuki; Uehara, Takanori; Noda, Kazutaka; Suzuki, Shingo; Shikino, Kiyoshi; Kajiwara, Hideki; Kondo, Takeshi; Hirota, Yusuke; Ikusaka, Masatomi

2017-02-27

We examined whether problem-based learning tutorials using patient-simulated videos showing daily life are more practical for clinical learning, compared with traditional paper-based problem-based learning, for the consideration rate of psychosocial issues and the recall rate for experienced learning. Twenty-two groups with 120 fifth-year students were each assigned paper-based problem-based learning and video-based problem-based learning using patient-simulated videos. We compared target achievement rates in questionnaires using the Wilcoxon signed-rank test and discussion contents diversity using the Mann-Whitney U test. A follow-up survey used a chi-square test to measure students' recall of cases in three categories: video, paper, and non-experienced. Video-based problem-based learning displayed significantly higher achievement rates for imagining authentic patients (p=0.001), incorporating a comprehensive approach including psychosocial aspects (p<0.001), and satisfaction with sessions (p=0.001). No significant differences existed in the discussion contents diversity regarding the International Classification of Primary Care Second Edition codes and chapter types or in the rate of psychological codes. In a follow-up survey comparing video and paper groups to non-experienced groups, the rates were higher for video (χ 2 =24.319, p<0.001) and paper (χ 2 =11.134, p=0.001). Although the video rate tended to be higher than the paper rate, no significant difference was found between the two. Patient-simulated videos showing daily life facilitate imagining true patients and support a comprehensive approach that fosters better memory. The clinical patient-simulated video method is more practical and clinical problem-based tutorials can be implemented if we create patient-simulated videos for each symptom as teaching materials.

Observational Study to Assess the Therapeutic Value of Four Ovarian Hyperstimulation Protocols in IVF After Pituitary Suppression with GnRH Antagonists in Normally Responding Women.

PubMed

Ana, Monzó; Vicente, Montañana; María, Rubio José; Trinidad, García-Gimeno; Alberto, Romeu

2011-02-22

To compare the clinical results of four different protocols of COH for IVF-ICSI in normovulatory women, using in all cases pituitary suppression with GnRH antagonists. A single center, open label, parallel-controlled, prospective, post-authorization study under the approved conditions for use where 305 normal responders women who were candidates to COH were assigned to r-FSH +hp-hMG (n = 51, Group I), hp-hMG (n = 61, Group II), fixed-dose r-FSH (n = 118, Group III), and r-FSH with potential dose adjustment (n = 75, Group IV) to subsequently undergo IVF-ICSI. During stimulation, Group IV needed significantly more days of stimulation as compared to Group II [8.09 ± 1.25 vs. 7.62 ± 1.17; P < 0.05], but was the group in which more oocytes were recovered [Group I: 9.43 ± 4.99 vs. Group II: 8.96 ± 4.82 vs. Group III: 8.78 ± 3.72 vs. Group IV: 11.62 ± 5.80; P < 0.05]. No significant differences were seen between the groups in terms of clinical and ongoing pregnancy, but among patients in whom two embryos with similar quality parameters (ASEBIR) were transferred, the group treated with hp-hMG alone achieved a significantly greater clinical pregnancy rate as compared to all other groups [Group I: 31.6%, Group II: 56.4%, Group III: 28.7%, Group IV: 32.7%; P < 0.05]. Although randomized clinical trials should be conducted to achieve a more reliable conclusion, these observations support the concept that stimulation with hp-hMG could be beneficial in normal responders women undergoing pituitary suppression with GnRH antagonists.

TH-EF-BRB-03: Significant Cord and Esophagus Dose Reduction by 4π Non-Coplanar Spine Stereotactic Body Radiation Therapy and Stereotactic Radiosurgery

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

Yu, V; Tran, A; Nguyen, D

Purpose: To demonstrate significant organ-at-risk (OAR) sparing achievable with 4π non-coplanar radiotherapy on spine SBRT and SRS patients. Methods: Twenty-five stereotactic spine cases previously treated with VMAT (n = 23) or IMRT (n = 2) were included in this study. A computer-aided-design model of a Linac with a 3D-scanned human surface was utilized to determine the feasible beam space throughout the 4π steradian and beam specific source-to-target-distances (STD) required for collision avoidance. 4π radiotherapy plans integrating beam orientation and fluence map optimization were then created using a column-generation algorithm. Twenty optimal beams were selected for each case. To evaluate themore » tradeoff between dosimetric benefit and treatment complexity, 4π plans including only isocentrically deliverable beams were also created. Beam angles of all standard and isocentric 4π plans were imported into Eclipse to recalculate the dose using the same calculation engine as the clinical plans for unbiased comparison. OAR and PTV dose statistics for the clinical, standard-4π, and isocentric-4π plans were compared. Results: Comparing standard-4π to clinical plans, particularly significant average percent reduction in the [mean, maximum] dose of the cord and esophagus of [41%, 21.7%], and [38.7%, 36.4%] was observed, along with global decrease in all other OAR dose statistics. The average cord volume receiving more than 50% prescription dose was substantially decreased by 76%. In addition, improved PTV coverage was demonstrated with a maximum dose reduction of 0.93% and 1.66% increase in homogeneity index (D95/D5). All isocentric-4π plans achieved dosimetric performance equivalent to that of the standard-4π plans with higher delivery complexity. Conclusion: 4π radiotherapy significantly improves stereotactic spine treatment dosimetry. With the substantial OAR dose sparing, PTV dose escalation is considerably safer. Isocentric-4π is sufficient to achieve the dosimetric gain. The successful implementation of 4π using an FDA approved planning system paves the way for a prospective clinical trial. Varian Medical Systems, NIH R43CA183390 and R01CA188300, NSF graduate research fellowship DGE-1144087.« less

Personalized Hypertension Management Using Patient-Generated Health Data Integrated With Electronic Health Records (EMPOWER-H): Six-Month Pre-Post Study

PubMed Central

Lv, Nan; Xiao, Lan; Simmons, Martha L; Rosas, Lisa G; Chan, Albert

2017-01-01

Background EMPOWER-H (Engaging and Motivating Patients Online With Enhanced Resources-Hypertension) is a personalized-care model facilitating engagement in hypertension self-management utilizing an interactive Web-based disease management system integrated with the electronic health record. The model is designed to support timely patient-provider interaction by incorporating decision support technology to individualize care and provide personalized feedback for patients with chronic disease. Central to this process were patient-generated health data, including blood pressure (BP), weight, and lifestyle behaviors, which were uploaded using a smartphone. Objective The aim of this study was to evaluate the program among patients within primary care already under management for hypertension and with uncontrolled BP. Methods Using a 6-month pre-post design, outcome measures included office-measured and home-monitored BP, office-measured weight, intervention contacts, diet, physical activity, smoking, knowledge, and health-related quality of life. Results At 6 months, 55.9% of participants (N=149) achieved office BP goals (<140/90 mm Hg; P<.001) and 86.0% achieved clinically meaningful reduction in office BP (reduction in systolic BP [SBP] ≥5 mm Hg or diastolic BP [DBP] ≥3 mm Hg). At baseline, 25.2% of participants met home BP goals (<135/85 mm Hg), and this percentage significantly increased to 71.4% (P<.001) at 6 months. EMPOWER-H also significantly reduced both office and home SBP and DBP, decreased office-measured weight and consumption of high-salt and high-fat foods (all P<.005), and increased intake of fruit and vegetables, minutes of aerobic exercise, and hypertension knowledge (all P<.05). Patients with higher home BP upload frequencies had significantly higher odds of achieving home BP goals. Patients receiving more total intervention, behavioral, pharmaceutical contacts had significantly lower odds of achieving home BP goals but higher improvements in office BP (all P<.05). Conclusions EMPOWER-H significantly improved participants’ office-measured and home-monitored BP, weight, and lifestyle behaviors, suggesting that technologically enabled BP home-monitoring, with structured use of patient-generated health data and a personalized care-plan facilitating patient engagement, can support effective clinical management. The experience gained in this study provides support for the feasibility and value of using carefully managed patient-generated health data in the day-to-day clinical management of patients with chronic conditions. A large-scale, real-world study to evaluate sustained effectiveness, cost-effectiveness, and scalability is warranted. PMID:28928111

Effects of methylprednisolone on the duration of rocuronium-induced neuromuscular block

PubMed Central

Geng, Weilian; Nie, Yuyan; Huang, Shaoqiang

2017-01-01

Abstract Background: We aim to investigate whether intraoperative use of methylprednisolone could affect the duration of rocuronium-induced neuromuscular blockade. Methods: A double blind, randomized, placebo-controlled trial was conducted. A total of 136 patients underwent gynecologic laparoscopic surgery were randomly divided into 3 groups: pregroup, receiving intravenous injection of methylprednisolone (40 mg) 30 minutes before induction of anesthesia; postgroup, receiving intravenous injection of methylprednisolone (40 mg) immediately after induction of anesthesia and intubation; and control group, receiving intravenous injection of normal saline. Patients were intravenously administrated with rocuronium 0.6 mg/kg, and changes in adductor policies evoked twitch responses were measured by ulnar nerve stimulator. Results: We found that all patients achieved maximum blockade effects, and there was no difference in onset time among the 2 groups. For time required to achieve train-of-four ratio (TOFR) 90%, pregroup (64.50 ± 10.52 minutes) and postgroup (65.29 ± 11.64 minutes) were significantly shorter than that of the control group (71.04 ± 10.55 minutes, P = .027), whereas clinical duration and total duration were significantly shorter in the 2 groups received methylprednisolone than the control group. However, there was no significant difference between the 2 treatment groups either in clinical duration and total duration of muscle relaxants, or time required to achieve TOFR 90%. No significant difference was found in recovery index among the 3 groups. Conclusion: Our findings suggest that a single intravenous injection of methylprednisolone, no matter preoperatively or intraoperatively, could shorten the duration of rocuronium-induced neuromuscular blockade. PMID:28953616

Clinical characteristics, surgical and neuropsychological outcomes in drug resistant tumoral temporal lobe epilepsy.

PubMed

Ravat, Sangeeta; Iyer, Vivek; Muzumdar, Dattatraya; Shah, Urvashi; Pradhan, Pranjali; Jain, Neeraj; Godge, Yogesh

2016-12-01

Glioneuronal tumors are found in nearly one third patients who undergo surgery for pharmacoresistant epilepsy with temporal lobe being the most common location. Few studies, however have concentrated on the neurological and neuropsychological outcomes after surgery, hitherto none from India. We studied 34 patients with temporal lobe tumors and drug resistant epilepsy. These patients underwent anterior temporal lobectomy or lesionectomy based on the involvement of the hippocampus and mesial temporal structures. The clinical history, EEG, neuropsychology profile and MRI were compared. Seizure outcome was categorized using Engel's classification. At a mean follow up of 62 months, 85.29% of the patients were seizure free (Engel's Class I). All 8 patients with intraoperative electrocorticography (ECoG) guided resection were seizure free. Presence of a residual lesion was significantly associated with persistence of seizures post surgery (p = 0.002). Group analysis revealed no significant shifts in IQ and memory scores postoperatively. There was a significant improvement in the quality of life scores (total and across all subdomains) in all patients (p < 0.001). Postoperative EEG abnormalities predicted unfavorable ​seizure outcome. Surgery for temporal lobe tumors and refractory epilepsy offers complete seizure freedom in majority. Complete surgical excision of the epileptogenic zone is of paramount importance in achieving seizure freedom. Intraoperative electrocorticography (EcoG) is a useful adjunct to ensure complete removal of epileptogenic zone, thus achieving optimal seizure freedom. There is a significant improvement in the quality of life scores (p < 0.001) with no negative impact of surgery on memory and intelligence. Even the patients who are not seizure free can achieve worthwhile improvement post surgery. Copyright © 2015 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Uncertainty in assessing value of oncology treatments.

PubMed

Mullins, C Daniel; Montgomery, Russ; Tunis, Sean

2010-01-01

Patients, clinicians, payers, and policymakers face an environment of significant evidentiary uncertainty as they attempt to achieve maximum value, or the greatest level of benefit possible at a given level of cost in their respective health care decisions. This is particularly true in the area of oncology, for which published evidence from clinical trials is often incongruent with real-world patient care, and a substantial portion of clinical use is for off-label indications that have not been systematically evaluated. It is this uncertainty in the knowledge of the clinical harms and benefits associated with oncology treatments that prevents postregulatory decision makers from making accurate assessments of the value of these treatments. Because of the incentives inherent in the clinical research enterprise, randomized control trials (RCTs) are designed for the specific purpose of regulatory approval and maximizing market penetration. The pursuit of these goals results in RCT study designs that achieve maximal internal validity at the expense of generalizability to diverse real-world patient populations that may have significant comorbidities and other clinically mitigating factors. As such, systematic reviews for the purposes of coverage and treatment decisions often find relevant and high-quality evidence to be limited or nonexistent. For a number of reasons, including frequent off-label use of medications and the expedited approval process for cancer drugs by the U.S. Food and Drug Administration, this situation is exacerbated in the area of oncology. This paper investigates the convergence of incentives and circumstances that lead to widespread uncertainty in oncology and proposes new paradigms for clinical research, including pragmatic clinical trials, methodological guidance, and coverage with evidence development. Each of these initiatives would support the design of clinical research that is more informative for postregulatory decision makers, and would therefore reduce uncertainty and provide greater confidence in conclusions about the value of these treatments.

Recognition of medication information from discharge summaries using ensembles of classifiers.

PubMed

Doan, Son; Collier, Nigel; Xu, Hua; Pham, Hoang Duy; Tu, Minh Phuong

2012-05-07

Extraction of clinical information such as medications or problems from clinical text is an important task of clinical natural language processing (NLP). Rule-based methods are often used in clinical NLP systems because they are easy to adapt and customize. Recently, supervised machine learning methods have proven to be effective in clinical NLP as well. However, combining different classifiers to further improve the performance of clinical entity recognition systems has not been investigated extensively. Combining classifiers into an ensemble classifier presents both challenges and opportunities to improve performance in such NLP tasks. We investigated ensemble classifiers that used different voting strategies to combine outputs from three individual classifiers: a rule-based system, a support vector machine (SVM) based system, and a conditional random field (CRF) based system. Three voting methods were proposed and evaluated using the annotated data sets from the 2009 i2b2 NLP challenge: simple majority, local SVM-based voting, and local CRF-based voting. Evaluation on 268 manually annotated discharge summaries from the i2b2 challenge showed that the local CRF-based voting method achieved the best F-score of 90.84% (94.11% Precision, 87.81% Recall) for 10-fold cross-validation. We then compared our systems with the first-ranked system in the challenge by using the same training and test sets. Our system based on majority voting achieved a better F-score of 89.65% (93.91% Precision, 85.76% Recall) than the previously reported F-score of 89.19% (93.78% Precision, 85.03% Recall) by the first-ranked system in the challenge. Our experimental results using the 2009 i2b2 challenge datasets showed that ensemble classifiers that combine individual classifiers into a voting system could achieve better performance than a single classifier in recognizing medication information from clinical text. It suggests that simple strategies that can be easily implemented such as majority voting could have the potential to significantly improve clinical entity recognition.

CIS: where are we going and what should we demand from industry?

PubMed

Frassica, Joseph J

2004-12-01

Clinical information systems designed for use in the critical care setting have been available for many years. Yet, despite significant evidence that these systems contribute to patient safety and efficiency of care, they have not achieved widespread use. This paper examines some of the factors responsible for the slow growth in use of clinical information systems in the intensive care unit. We further examine the elements that will be necessary to support widespread adoption of future clinical information systems. We give an outline of functionalities, processes, and standards that users will demand from industry as they develop the information systems of the future.

The English-Language and Reading Achievement of a Cohort of Deaf Students Speaking and Signing Standard English: A Preliminary Study.

PubMed

Nielsen, Diane Corcoran; Luetke, Barbara; McLean, Meigan; Stryker, Deborah

2016-01-01

Research suggests that English-language proficiency is critical if students who are deaf or hard of hearing (D/HH) are to read as their hearing peers. One explanation for the traditionally reported reading achievement plateau when students are D/HH is the inability to hear insalient English morphology. Signing Exact English can provide visual access to these features. The authors investigated the English morphological and syntactic abilities and reading achievement of elementary and middle school students at a school using simultaneously spoken and signed Standard American English facilitated by intentional listening, speech, and language strategies. A developmental trend (and no plateau) in language and reading achievement was detected; most participants demonstrated average or above-average English. Morphological awareness was prerequisite to high test scores; speech was not significantly correlated with achievement; language proficiency, measured by the Clinical Evaluation of Language Fundamentals-4 (Semel, Wiig, & Secord, 2003), predicted reading achievement.

Standardized versus custom parenteral nutrition: impact on clinical and cost-related outcomes.

PubMed

Blanchette, Lisa M; Huiras, Paul; Papadopoulos, Stella

2014-01-15

Results of a study comparing clinical and cost outcomes with the use of standardized versus custom-prepared parenteral nutrition (PN) in an acute care setting are reported. In a retrospective pre-post analysis, nutritional target attainment, electrolyte abnormalities, and other outcomes were compared in patients 15 years of age or older who received custom PN (n = 49) or a standardized PN product (n = 57) for at least 72 hours at a large medical center over a 13-month period; overall, 45% of the cases were intensive care unit (ICU) admissions. A time-and-motion assessment was conducted to determine PN preparation times. There were no significant between-group differences in the percentage of patients who achieved estimated caloric requirements or in mean ICU or hospital length of stay. However, patients who received standardized PN were significantly less likely than those who received custom PN to achieve the highest protein intake goal (63% versus 92%, p = 0.003) and more likely to develop hyponatremia (37% versus 14%, p = 0.01). Pharmacy preparation times averaged 20 minutes for standardized PN and 80 minutes for custom PN; unit costs were $61.06 and $57.84, respectively. A standardized PN formulation was as effective as custom PN in achieving estimated caloric requirements, but it was relatively less effective in achieving 90% of estimated protein requirements and was associated with a higher frequency of hyponatremia. The standardized PN product may be a cost-effective formulation for institutions preparing an average of five or fewer PN orders per day.

Delivering preference for place of death in a specialist palliative care setting.

PubMed

Oxenham, David; Finucane, Anne; Arnold, Elizabeth; Russell, Papiya

2013-01-01

Over the last 10 years, one of the key themes of public policy in palliative care has been achievement of choice in place of death. In Marie Curie Hospice Edinburgh a baseline audit conducted in 2006 showed that only a small proportion (18%) of patients referred to hospice services died at home. The audit also revealed that only 31% of those who expressed a preference to die at home were able to do so, whereas 91% of those who chose a setting other than home achieved their preference. Overall achievement of preferred place of death was 56%. However a significant number of patients (29%) did not have a recorded preference. A programme of quality improvement has continued over the last 7 years to improve identification, communication and achievement of preferred place of death for all patients. The mechanisms to change practice have been: changes to documentation; changes to clinical systems to support use of documentation; support for clinical staff to recognise the value of discussing preferences; and support for clinical staff to develop new skills. In addition the programme has been incorporated into local clinical strategy and this has enabled gaps in service to be addressed with a new service to support early discharge of those patients who wish to die at home. A recent audit showed that all patients had a recorded preference or a documented reason why their preference was unclarified. One third of patients died at home - nearly double the proportion that died at home in the baseline audit. Seventy one per cent of patients who wished to die at home actually died at home - a substantial increase from 31% at baseline. Achievement of preferred place of death for patients wishing to die in the hospice remained high at 88%. The focus on assessment of preference for place of death has led to substantial improvements in the identification and achievement of preference for patients dying under the care of the hospice. Furthermore, it has been associated with an increase in the overall proportion of patients who die at home.

Prediction of clinical behaviour and treatment for cancers.

PubMed

Futschik, Matthias E; Sullivan, Mike; Reeve, Anthony; Kasabov, Nikola

2003-01-01

Prediction of clinical behaviour and treatment for cancers is based on the integration of clinical and pathological parameters. Recent reports have demonstrated that gene expression profiling provides a powerful new approach for determining disease outcome. If clinical and microarray data each contain independent information then it should be possible to combine these datasets to gain more accurate prognostic information. Here, we have used existing clinical information and microarray data to generate a combined prognostic model for outcome prediction for diffuse large B-cell lymphoma (DLBCL). A prediction accuracy of 87.5% was achieved. This constitutes a significant improvement compared to the previously most accurate prognostic model with an accuracy of 77.6%. The model introduced here may be generally applicable to the combination of various types of molecular and clinical data for improving medical decision support systems and individualising patient care.

Clinical and Procedural Predictors of Outcomes From the Endovascular Treatment of Posterior Circulation Strokes.

PubMed

Mokin, Maxim; Sonig, Ashish; Sivakanthan, Sananthan; Ren, Zeguang; Elijovich, Lucas; Arthur, Adam; Goyal, Nitin; Kan, Peter; Duckworth, Edward; Veznedaroglu, Erol; Binning, Mandy J; Liebman, Kenneth M; Rao, Vikas; Turner, Raymond D; Turk, Aquilla S; Baxter, Blaise W; Dabus, Guilherme; Linfante, Italo; Snyder, Kenneth V; Levy, Elad I; Siddiqui, Adnan H

2016-03-01

Patients with posterior circulation strokes have been excluded from recent randomized endovascular stroke trials. We reviewed the recent multicenter experience with endovascular treatment of posterior circulation strokes to identify the clinical, radiographic, and procedural predictors of successful recanalization and good neurological outcomes. We performed a multicenter retrospective analysis of consecutive patients with posterior circulation strokes, who underwent thrombectomy with stent retrievers or primary aspiration thrombectomy (including A Direct Aspiration First Pass Technique [ADAPT] approach). We correlated clinical and radiographic outcomes with demographic, clinical, and technical characteristics. A total of 100 patients were included in the final analysis (mean age, 63.5±14.2 years; mean admission National Institutes of Health Stroke Scale score, 19.2±8.2). Favorable clinical outcome at 3 months (modified Rankin Scale score ≤2) was achieved in 35% of patients. Successful recanalization and shorter time from stroke onset to the start of the procedure were significant predictors of favorable clinical outcome at 90 days. Stent retriever and aspiration thrombectomy as primary treatment approaches showed comparable procedural and clinical outcomes. None of the baseline advanced imaging modalities (magnetic resonance imaging, computed tomographic perfusion, or computed tomography angiography assessment of collaterals) showed superiority in selecting patients for thrombectomy. Time to the start of the procedure is an important predictor of clinical success after thrombectomy in patients with posterior circulation strokes. Both stent retriever and aspiration thrombectomy as primary treatment approaches are effective in achieving successful recanalization. © 2016 American Heart Association, Inc.

Sex-specific predictive power of 6-minute walk test in chronic heart failure is not enhanced using percent achieved of published reference equations.

PubMed

Frankenstein, Lutz; Zugck, Christian; Nelles, Manfred; Schellberg, Dieter; Katus, Hugo; Remppis, Andrew

2008-04-01

The 6-minute walk test (6MWT) is an established prognostic tool in chronic heart failure. The strong influence of height, weight, age, and sex on 6MWT distance may be accounted for by using percentage achieved of predicted value rather than uncorrected 6MWT values. The study included 1069 patients (862 men) with a mean age 55.2 +/- 11.7 years and mean left ventricular ejection fraction of 29% +/- 10%, attending the heart failure clinic of the University of Heidelberg between 1995 and 2005. The predictive power and accuracy of 6MWT and achieved percentage values according to all available published equations for mortality and mortality or transplant combined were tested separately for each sex. The percentage values varied largely between equations. For all equations, women in New York Heart Association (NYHA) functional class I had higher values than men. Although the 6MWT significantly discriminated all NYHA classes for both sexes, only 1 equation discriminated all NYHA classes. No significant differences in the area under the receiver operating-characteristic curve were noted between achieved percentage values and 6MWT. Despite strong univariate significance, achieved percentage values did not retain multivariate significance. The 6MWT was independent from N-terminal brain natriuretic propeptide, NYHA, left ventricular ejection fraction, and peak oxygen uptake. We confirmed 6MWT to be a strong and independent risk predictor for both sexes. Because the prognostic power of 6MWT is not enhanced using percentage achieved of published reference equations, we suggest recalibration of these reference values rather than discarding this approach.

Selective robust optimization: A new intensity-modulated proton therapy optimization strategy

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

Li, Yupeng; Niemela, Perttu; Siljamaki, Sami

2015-08-15

Purpose: To develop a new robust optimization strategy for intensity-modulated proton therapy as an important step in translating robust proton treatment planning from research to clinical applications. Methods: In selective robust optimization, a worst-case-based robust optimization algorithm is extended, and terms of the objective function are selectively computed from either the worst-case dose or the nominal dose. Two lung cancer cases and one head and neck cancer case were used to demonstrate the practical significance of the proposed robust planning strategy. The lung cancer cases had minimal tumor motion less than 5 mm, and, for the demonstration of the methodology,more » are assumed to be static. Results: Selective robust optimization achieved robust clinical target volume (CTV) coverage and at the same time increased nominal planning target volume coverage to 95.8%, compared to the 84.6% coverage achieved with CTV-based robust optimization in one of the lung cases. In the other lung case, the maximum dose in selective robust optimization was lowered from a dose of 131.3% in the CTV-based robust optimization to 113.6%. Selective robust optimization provided robust CTV coverage in the head and neck case, and at the same time improved controls over isodose distribution so that clinical requirements may be readily met. Conclusions: Selective robust optimization may provide the flexibility and capability necessary for meeting various clinical requirements in addition to achieving the required plan robustness in practical proton treatment planning settings.« less

[Clinical use of statins and cholesterol goals in patients with several cardiovascular risk factors].

PubMed

Gómez-Belda, Ana; Rodilla, Enrique; Albert, Amparo; García, Luis; González, Carmen; Pascual, José M

2003-10-25

Our goal was to determine the number of patients who achieve low-density lipoprotein cholesterol (LDL-c) targets according to new guidelines. Descriptive and transversal study of patients from a cardiovascular clinic. LDL-c was calculated and targets were established according the NCEP-ATP III. 1,811 patients (46% males, 54% females) were studied. 35% of these were high-risk patients (group 1: coronary risk > 20% at 10 years), 19% were intermediate-risk patients (group 2: coronary risk 10-20% at 10 years) and 46% were low-risk patients (group 3: coronary risk < 10% at 10 years). Overall, 58% of patients achieved target LDL-c levels, yet success rates were 26% among group 1 patients, 51% among group 2 patients, and 86% among group 3 patients (p = 0.001, for differences between groups). Statin treatment was significantly related to achieving target LDL-c levels in group 1 patients (OR = 1.7; 95% CI, 1.2-2.4; p = 0.007). In group 1.41% of patients had LDL-c levels > 130 mg/dl without receiving lipid-lowering drugs. Although an overall 58% patients achieve target LDL-C levels, only one of four high-risk patients have LDL-c levels < 100 mg/dl, and statin treatment is a determining factor to achieve this goal. These findings indicate that a more aggressive treatment with statins is needed in secondary prevention.

Innovating With Rehabilitation Technology in the Real World: Promises, Potentials, and Perspectives.

PubMed

Chua, Karen Sui Geok; Kuah, Christopher Wee Keong

2017-10-01

In this article, we discuss robotic-assisted therapy as an emerging and significant field of clinical rehabilitation and its value proposition for innovating rehabilitation clinical practice. Attempts to achieve integration among clinicians' practices and bioengineers' machines often generate new challenges and controversies. To date, the literature is indicative of a sizeable number and variety of robotic devices in the field of clinical rehabilitation, some are commercially available; however, large-scale clinical outcomes are less positive than expected. The following main themes related to integrating rehabilitation technology in real-world clinical practice will be discussed: the application of current evidence-based practice and knowledge in relation to treatment in the rehabilitation clinic, perspectives from rehabilitation professionals using robotic-aided therapy with regard to challenges, and strategies for problem solving. Lastly, we present innovation philosophies with regard to sustainability of clinical rehabilitation technologies.

Innovating With Rehabilitation Technology in the Real World

PubMed Central

Chua, Karen Sui Geok; Kuah, Christopher Wee Keong

2017-01-01

Abstract In this article, we discuss robotic-assisted therapy as an emerging and significant field of clinical rehabilitation and its value proposition for innovating rehabilitation clinical practice. Attempts to achieve integration among clinicians' practices and bioengineers' machines often generate new challenges and controversies. To date, the literature is indicative of a sizeable number and variety of robotic devices in the field of clinical rehabilitation, some are commercially available; however, large-scale clinical outcomes are less positive than expected. The following main themes related to integrating rehabilitation technology in real-world clinical practice will be discussed: the application of current evidence-based practice and knowledge in relation to treatment in the rehabilitation clinic, perspectives from rehabilitation professionals using robotic-aided therapy with regard to challenges, and strategies for problem solving. Lastly, we present innovation philosophies with regard to sustainability of clinical rehabilitation technologies. PMID:28708632

Does neuropsychological performance impact on real-life functional achievements in obsessive-compulsive disorder? A preliminary study.

PubMed

Perna, Giampaolo; Cavedini, Paolo; Harvey, Philip D; Di Chiaro, Nunzia Valentina; Daccò, Silvia; Caldirola, Daniela

2016-11-01

We investigated the association between neuropsychological performance and real-life functioning in obsessive-compulsive disorder (OCD). As a secondary aim, we investigated the association between neuropsychological performance and self-reported quality of life (QoL). We retrospectively selected 68 of 240 inpatients with OCD, who had been hospitalised for a 4-week psychiatric rehabilitation programme. We used clinical information recorded in the patients' electronic medical records. We considered the following variables: neuropsychological performance (verbal/visual memory, sustained attention, visual-constructive ability, and language fluency; in a sub-sample of 37 subjects, divided attention, working memory, and attentional shifting were also available); real-life functional achievements (social/vocational outcomes and independent living); subjectively reported QoL (WHOQOL-BREF); obsessive-compulsive (OC) symptoms severity (DY-BOCS). We found significant associations between poorer neuropsychological performance and poorer achievements in independent living and vocational outcomes. Among the different neuropsychological tests, we found significant associations between language fluency/executive processing and independent living, and between divided attention, attentional shifting, working memory and vocational outcome. We found no significant associations between neuropsychological performance and subjectively reported QoL. OC symptoms severity was not associated with real-life functional achievements. Our preliminary results suggest that poorer neuropsychological performance may be associated with impaired real-life functioning in subjects with OCD.

Prognosis of thymectomy in myasthenia gravis patients with thymus hyperplasia.

PubMed

Yang, Jing; Liu, Chanchan; Li, Tao; Li, Chengyan

2017-09-01

To compare the post-thymectomy prognosis in different conditions of myasthenia gravis (MG) patients with thymus hyperplasia. Collecting medical record and carrying out the follow-up study of 123 myasthenia gravis patients with thymus hyperplasia who have underwent thymectomy during the period between 2003 and 2013. Dividing into different groups based on gender, age of onset, duration of disease and Myasthenia Gravis Association of America (MGFA) clinical classification to analyze different prognosis in different groups. Complete stable remission (CSR) was achieved in 71 of 123 patients (59.5%). There is no gender-related difference in achieving CSR. Patients with early onset of MG (≤40 years old) or disease duration less than 12 months had significantly higher CSR rates than those with late onset of MG (>40 years old) or disease duration more than 12 months respectively, while no difference was found in remission rate between MGFA clinical classification I and MGFA II. Myasthenia gravis patients with thymus hyperplasia who had thymectomy are proved to possess greater chance of achieving CSR. The onset age of disease and duration are the prognostic factors.

The Role of Laser Speckle Imaging in Port-Wine Stain Research: Recent Advances and Opportunities

PubMed Central

Choi, Bernard; Tan, Wenbin; Jia, Wangcun; White, Sean M.; Moy, Wesley J.; Yang, Bruce Y.; Zhu, Jiang; Chen, Zhongping; Kelly, Kristen M.; Nelson, J. Stuart

2016-01-01

Here, we review our current knowledge on the etiology and treatment of port-wine stain (PWS) birthmarks. Current treatment options have significant limitations in terms of efficacy. With the combination of 1) a suitable preclinical microvascular model, 2) laser speckle imaging (LSI) to evaluate blood-flow dynamics, and 3) a longitudinal experimental design, rapid preclinical assessment of new phototherapies can be translated from the lab to the clinic. The combination of photodynamic therapy (PDT) and pulsed-dye laser (PDL) irradiation achieves a synergistic effect that reduces the required radiant exposures of the individual phototherapies to achieve persistent vascular shutdown. PDL combined with anti-angiogenic agents is a promising strategy to achieve persistent vascular shutdown by preventing reformation and reperfusion of photocoagulated blood vessels. Integration of LSI into the clinical workflow may lead to surgical image guidance that maximizes acute photocoagulation, is expected to improve PWS therapeutic outcome. Continued integration of noninvasive optical imaging technologies and biochemical analysis collectively are expected to lead to more robust treatment strategies. PMID:27013846

Fully automated treatment planning for head and neck radiotherapy using a voxel-based dose prediction and dose mimicking method

NASA Astrophysics Data System (ADS)

McIntosh, Chris; Welch, Mattea; McNiven, Andrea; Jaffray, David A.; Purdie, Thomas G.

2017-08-01

Recent works in automated radiotherapy treatment planning have used machine learning based on historical treatment plans to infer the spatial dose distribution for a novel patient directly from the planning image. We present a probabilistic, atlas-based approach which predicts the dose for novel patients using a set of automatically selected most similar patients (atlases). The output is a spatial dose objective, which specifies the desired dose-per-voxel, and therefore replaces the need to specify and tune dose-volume objectives. Voxel-based dose mimicking optimization then converts the predicted dose distribution to a complete treatment plan with dose calculation using a collapsed cone convolution dose engine. In this study, we investigated automated planning for right-sided oropharaynx head and neck patients treated with IMRT and VMAT. We compare four versions of our dose prediction pipeline using a database of 54 training and 12 independent testing patients by evaluating 14 clinical dose evaluation criteria. Our preliminary results are promising and demonstrate that automated methods can generate comparable dose distributions to clinical. Overall, automated plans achieved an average of 0.6% higher dose for target coverage evaluation criteria, and 2.4% lower dose at the organs at risk criteria levels evaluated compared with clinical. There was no statistically significant difference detected in high-dose conformity between automated and clinical plans as measured by the conformation number. Automated plans achieved nine more unique criteria than clinical across the 12 patients tested and automated plans scored a significantly higher dose at the evaluation limit for two high-risk target coverage criteria and a significantly lower dose in one critical organ maximum dose. The novel dose prediction method with dose mimicking can generate complete treatment plans in 12-13 min without user interaction. It is a promising approach for fully automated treatment planning and can be readily applied to different treatment sites and modalities.

WE-DE-201-01: BEST IN PHYSICS (THERAPY): A Fast Multi-Target Inverse Treatment Planning Strategy Optimizing Dosimetric Measures for High-Dose-Rate (HDR) Brachytherapy

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

Guthier, C; University Medical Center Mannheim, Mannheim; Harvard Medical School, Boston, MA

Purpose: Inverse treatment planning (ITP) for interstitial HDR brachytherapy of gynecologic cancers seeks to maximize coverage of the clinical target volumes (tumor and vagina) while respecting dose-volume-histogram related dosimetric measures (DMs) for organs at risk (OARs). Commercially available ITP tools do not support DM-based planning because it is computationally too expensive to solve. In this study we present a novel approach that allows fast ITP for gynecologic cancers based on DMs for the first time. Methods: This novel strategy is an optimization model based on a smooth DM-based objective function. The smooth approximation is achieved by utilizing a logistic functionmore » for the evaluation of DMs. The resulting nonconvex and constrained optimization problem is then optimized with a BFGS algorithm. The model was evaluated using the implant geometry extracted from 20 patient treatment plans under an IRB-approved retrospective study. For each plan, the final DMs were evaluated and compared to the original clinical plans. The CTVs were the contoured tumor volume and the contoured surface of the vagina. Statistical significance was evaluated with a one-sided paired Wilcoxon signed-rank test. Results: As did the clinical plans, all generated plans fulfilled the defined DMs for OARs. The proposed strategy showed a statistically significant improvement (p<0.001) in coverage of the tumor and vagina, with absolute improvements of related DMs of (6.9 +/− 7.9)% and (28.2 +/− 12.0)%, respectively. This was achieved with a statistically significant (p<0.01) decrease of the high-dose-related DM for the tumor. The runtime of the optimization was (2.3 +/− 2.0) seconds. Conclusion: We demonstrated using clinical data that our novel approach allows rapid DM-based optimization with improved coverage of CTVs with fewer hot spots. Being up to three orders of magnitude faster than the current clinical practice, the method dramatically shortens planning time.« less

Comparison between zero-profile spacer and plate with cage in the treatment of single level cervical spondylosis.

PubMed

Lan, Tao; Lin, Jian-Ze; Hu, Shi-Yu; Yang, Xin-Jian; Chen, Yang

2018-01-01

Retrospective study of 68 patients of symptomatic cervical spondylosis who were treated by anterior cervical discectomy and fusion (ACDF). The purpose of this study was to compare the clinical and radiological outcomes of patients with single level cervical spondylosis using either zero-profile spacer (group A) or anterior cervical plate and cage (group B). Clinical and radiological data of 68 patients undergoing ACDF from C3-C7 were collected retrospectively. There were 35 patients with a mean age of 54.05 years who received treatment by zero-profile implant. A total of 33 patients with a mean age of 52.09 years underwent fusion by traditional plate with cage. Group A and group B were followed up for an average of 23.68 months and 24.39 months, respectively. Age, blood loss, and operation time were assessed. The clinical outcomes were evaluated by JOA and VAS score before and after surgery. In addition, incidence of dysphagia was recorded. The Cobb angle (from C2 to C7) change was measured on the lateral cervical spine radiographs. There was no significant difference in terms of operation time and blood loss between two groups. The postoperative JOA significantly increased and the VAS decreased correspondently in both groups. The postoperative Cobb angle increased and showed statistical difference compared with preoperative Cobb angle in both groups. There was no significant difference between group A and group B in achieving clinical symptoms and radiograph improvement according to postoperative JOA, VAS and Cobb angle comparison. The incidence of postoperative dysphagia was lower in the group A than group B. Our study suggests that the application of zero-p spacer can achieve similar clinical and radiological improvement compared with traditional plate and cage. Meanwhile, zero-p is superior to plate and cage with a lower incidence of postoperative dysphagia.

Mid-Treatment Sleep Duration Predicts Clinically Significant Knee Osteoarthritis Pain reduction at 6 months: Effects From a Behavioral Sleep Medicine Clinical Trial.

PubMed

Salwen, Jessica K; Smith, Michael T; Finan, Patrick H

2017-02-01

To determine the relative influence of sleep continuity (sleep efficiency, sleep onset latency, total sleep time [TST], and wake after sleep onset) on clinical pain outcomes within a trial of cognitive behavioral therapy for insomnia (CBT-I) for patients with comorbid knee osteoarthritis and insomnia. Secondary analyses were performed on data from 74 patients with comorbid insomnia and knee osteoarthritis who completed a randomized clinical trial of 8-session multicomponent CBT-I versus an active behavioral desensitization control condition (BD), including a 6-month follow-up assessment. Data used herein include daily diaries of sleep parameters, actigraphy data, and self-report questionnaires administered at specific time points. Patients who reported at least 30% improvement in self-reported pain from baseline to 6-month follow-up were considered responders (N = 31). Pain responders and nonresponders did not differ significantly at baseline across any sleep continuity measures. At mid-treatment, only TST predicted pain response via t tests and logistic regression, whereas other measures of sleep continuity were nonsignificant. Recursive partitioning analyses identified a minimum cut-point of 382 min of TST achieved at mid-treatment in order to best predict pain improvements 6-month posttreatment. Actigraphy results followed the same pattern as daily diary-based results. Clinically significant pain reductions in response to both CBT-I and BD were optimally predicted by achieving approximately 6.5 hr sleep duration by mid-treatment. Thus, tailoring interventions to increase TST early in treatment may be an effective strategy to promote long-term pain reductions. More comprehensive research on components of behavioral sleep medicine treatments that contribute to pain response is warranted. © Sleep Research Society 2016. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

Fully automated treatment planning for head and neck radiotherapy using a voxel-based dose prediction and dose mimicking method.

PubMed

McIntosh, Chris; Welch, Mattea; McNiven, Andrea; Jaffray, David A; Purdie, Thomas G

2017-07-06

Recent works in automated radiotherapy treatment planning have used machine learning based on historical treatment plans to infer the spatial dose distribution for a novel patient directly from the planning image. We present a probabilistic, atlas-based approach which predicts the dose for novel patients using a set of automatically selected most similar patients (atlases). The output is a spatial dose objective, which specifies the desired dose-per-voxel, and therefore replaces the need to specify and tune dose-volume objectives. Voxel-based dose mimicking optimization then converts the predicted dose distribution to a complete treatment plan with dose calculation using a collapsed cone convolution dose engine. In this study, we investigated automated planning for right-sided oropharaynx head and neck patients treated with IMRT and VMAT. We compare four versions of our dose prediction pipeline using a database of 54 training and 12 independent testing patients by evaluating 14 clinical dose evaluation criteria. Our preliminary results are promising and demonstrate that automated methods can generate comparable dose distributions to clinical. Overall, automated plans achieved an average of 0.6% higher dose for target coverage evaluation criteria, and 2.4% lower dose at the organs at risk criteria levels evaluated compared with clinical. There was no statistically significant difference detected in high-dose conformity between automated and clinical plans as measured by the conformation number. Automated plans achieved nine more unique criteria than clinical across the 12 patients tested and automated plans scored a significantly higher dose at the evaluation limit for two high-risk target coverage criteria and a significantly lower dose in one critical organ maximum dose. The novel dose prediction method with dose mimicking can generate complete treatment plans in 12-13 min without user interaction. It is a promising approach for fully automated treatment planning and can be readily applied to different treatment sites and modalities.

Questionnaire-based assessment of executive functioning: Psychometrics.

PubMed

Castellanos, Irina; Kronenberger, William G; Pisoni, David B

2018-01-01

The psychometric properties of the Learning, Executive, and Attention Functioning (LEAF) scale were investigated in an outpatient clinical pediatric sample. As a part of clinical testing, the LEAF scale, which broadly measures neuropsychological abilities related to executive functioning and learning, was administered to parents of 118 children and adolescents referred for psychological testing at a pediatric psychology clinic; 85 teachers also completed LEAF scales to assess reliability across different raters and settings. Scores on neuropsychological tests of executive functioning and academic achievement were abstracted from charts. Psychometric analyses of the LEAF scale demonstrated satisfactory internal consistency, parent-teacher inter-rater reliability in the small to large effect size range, and test-retest reliability in the large effect size range, similar to values for other executive functioning checklists. Correlations between corresponding subscales on the LEAF and other behavior checklists were large, while most correlations with neuropsychological tests of executive functioning and achievement were significant but in the small to medium range. Results support the utility of the LEAF as a reliable and valid questionnaire-based assessment of delays and disturbances in executive functioning and learning. Applications and advantages of the LEAF and other questionnaire measures of executive functioning in clinical neuropsychology settings are discussed.

Comparison of computer-assisted instruction (CAI) versus traditional textbook methods for training in abdominal examination (Japanese experience).

PubMed

Qayumi, A K; Kurihara, Y; Imai, M; Pachev, G; Seo, H; Hoshino, Y; Cheifetz, R; Matsuura, K; Momoi, M; Saleem, M; Lara-Guerra, H; Miki, Y; Kariya, Y

2004-10-01

This study aimed to compare the effects of computer-assisted, text-based and computer-and-text learning conditions on the performances of 3 groups of medical students in the pre-clinical years of their programme, taking into account their academic achievement to date. A fourth group of students served as a control (no-study) group. Participants were recruited from the pre-clinical years of the training programmes in 2 medical schools in Japan, Jichi Medical School near Tokyo and Kochi Medical School near Osaka. Participants were randomly assigned to 4 learning conditions and tested before and after the study on their knowledge of and skill in performing an abdominal examination, in a multiple-choice test and an objective structured clinical examination (OSCE), respectively. Information about performance in the programme was collected from school records and students were classified as average, good or excellent. Student and faculty evaluations of their experience in the study were explored by means of a short evaluation survey. Compared to the control group, all 3 study groups exhibited significant gains in performance on knowledge and performance measures. For the knowledge measure, the gains of the computer-assisted and computer-assisted plus text-based learning groups were significantly greater than the gains of the text-based learning group. The performances of the 3 groups did not differ on the OSCE measure. Analyses of gains by performance level revealed that high achieving students' learning was independent of study method. Lower achieving students performed better after using computer-based learning methods. The results suggest that computer-assisted learning methods will be of greater help to students who do not find the traditional methods effective. Explorations of the factors behind this are a matter for future research.

Higher Improvement in Patient-Reported Outcomes Can Be Achieved After Transforaminal Lumbar Interbody Fusion for Clinical and Radiographic Degenerative Spondylolisthesis Classification Type D Degenerative Lumbar Spondylolisthesis.

PubMed

Chen, Xi; Xu, Liang; Qiu, Yong; Chen, Zhong-Hui; Zhou, Qing-Shuang; Li, Song; Sun, Xu

2018-06-01

Clinical and radiographic degenerative spondylolisthesis (CARDS) classification defines a distinct subset of patients with kyphotic angulation at the involved segment (type D). Research using CARDS classification to investigate motion characteristics at involved segments or patient-related outcomes (PROs) following surgical intervention is sparse. We investigated the relationship between CARDS type D spondylolisthesis and dynamic instability and PROs in type D versus non-type D spondylolisthesis. We reviewed consecutive patients who received transforaminal lumbar interbody fusion for L4-5 spondylolisthesis between 2009 and 2015. Patients were assigned into type D and non-type D groups. Translational motion was determined by upright lumbar lateral radiography with supine sagittal magnetic resonance imaging or flexion and extension radiography. Demographics, radiographic parameters, and PROs were evaluated. Type D and non-type D groups comprised 34 and 163 patients, respectively. Compared with non-type D, type D group was characterized by lordotic angulation loss and higher degree of olisthesis on upright radiographs and demonstrated higher translational motion on upright lumbar lateral radiography with supine sagittal magnetic resonance imaging analysis. After surgery, mean reduction rate was significantly higher in type D group; type D had less slippage, but differences in slip angle and disc height were not significant. Preoperative Oswestry Disability Index and visual analog scale for back pain scores were higher in type D group. Type D spondylolisthesis and dynamic instability were associated with achieving minimal clinically important differences in PROs. CARDS type D spondylolisthesis is a distinct subset associated with dynamic instability and worse PROs. Higher improvement in PROs can be achieved in CARDS type D spondylolisthesis after surgery. Copyright © 2018 Elsevier Inc. All rights reserved.

Correlations of circulating peptide YY and ghrelin with body weight, rate of weight gain, and time required to achieve the recommended daily intake in preterm infants.

PubMed

Chen, XiaFang; Du, XueLiang; Zhu, JianXing; Xie, LiJuan; Zhang, YongJun; He, ZhenJuan

2012-07-01

The objective was to elucidate the relationships between serum concentrations of the gut hormone peptide YY (PYY) and ghrelin and growth development in infants for potential application to the clinical observation index. Serum concentrations of PYY and ghrelin were measured using radioimmunoassay from samples collected at the clinic. For each patient, gestational age, birth weight, time required to return to birth weight, rate of weight gain, time required to achieve recommended daily intake (RDI) standards, time required for full-gastric feeding, duration of hospitalization, and time of administration of total parenteral nutrition were recorded. Serum PYY and ghrelin concentrations were significantly higher in the preterm group (N = 20) than in the full-term group (N = 20; P < 0.01). Within the preterm infant group, the serum concentrations of PYY and ghrelin on postnatal day (PND) 7 (ghrelin = 1485.38 ± 409.24; PYY = 812.37 ± 153.77 ng/L) were significantly higher than on PND 1 (ghrelin = 956.85 ± 223.09; PYY = 545.27 ± 204.51 ng/L) or PND 3 (ghrelin = 1108.44 ± 351.36; PYY = 628.96 ± 235.63 ng/L; P < 0.01). Both serum PYY and ghrelin concentrations were negatively correlated with body weight, and the degree of correlation varied with age. Serum ghrelin concentration correlated negatively with birth weight and positively with the time required to achieve RDI (P < 0.05). In conclusion, serum PYY and ghrelin concentrations reflect a negative energy balance, predict postnatal growth, and enable compensation. Further studies are required to elucidate the precise concentration and roles of PYY and ghrelin in newborns and to determine the usefulness of measuring these hormones in clinical practice.

Correlations of circulating peptide YY and ghrelin with body weight, rate of weight gain, and time required to achieve the recommended daily intake in preterm infants

PubMed Central

Chen, XiaFang; Du, Xueliang; Zhu, JianXing; Xie, LiJuan; Zhang, YongJun; He, ZhenJuan

2012-01-01

The objective was to elucidate the relationships between serum concentrations of the gut hormone peptide YY (PYY) and ghrelin and growth development in infants for potential application to the clinical observation index. Serum concentrations of PYY and ghrelin were measured using radioimmunoassay from samples collected at the clinic. For each patient, gestational age, birth weight, time required to return to birth weight, rate of weight gain, time required to achieve recommended daily intake (RDI) standards, time required for full-gastric feeding, duration of hospitalization, and time of administration of total parenteral nutrition were recorded. Serum PYY and ghrelin concentrations were significantly higher in the preterm group (N = 20) than in the full-term group (N = 20; P < 0.01). Within the preterm infant group, the serum concentrations of PYY and ghrelin on postnatal day (PND) 7 (ghrelin = 1485.38 ± 409.24; PYY = 812.37 ± 153.77 ng/L) were significantly higher than on PND 1 (ghrelin = 956.85 ± 223.09; PYY = 545.27 ± 204.51 ng/L) or PND 3 (ghrelin = 1108.44 ± 351.36; PYY = 628.96 ± 235.63 ng/L; P < 0.01). Both serum PYY and ghrelin concentrations were negatively correlated with body weight, and the degree of correlation varied with age. Serum ghrelin concentration correlated negatively with birth weight and positively with the time required to achieve RDI (P < 0.05). In conclusion, serum PYY and ghrelin concentrations reflect a negative energy balance, predict postnatal growth, and enable compensation. Further studies are required to elucidate the precise concentration and roles of PYY and ghrelin in newborns and to determine the usefulness of measuring these hormones in clinical practice. PMID:22527125

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.

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 EVALUATION OF THE RAPID ACCESS VITREAL INJECTION GUIDE: A Handheld Instrument for Assisting Intravitreal Injections.

PubMed

Han, Dennis P; McKenney, Kaitlin C; Kim, Judy E; Weinberg, David V; Musch, David C; Singh, Ravi S J

2017-04-01

The Rapid Access Vitreal Injection (RAVI) guide combines the function of an eyelid speculum and measuring caliper into a single instrument for assisting intravitreal injections. This study clinically evaluated the RAVI guide with respect to patient acceptance, complication rates, and operative goals. A prospective study was performed on 54 patients undergoing intravitreal injections using the RAVI guide (n = 32) or the speculum/caliper (n = 22). Device-related pain was assessed using the Wong-Baker scoring system, scaled from 0 (no pain) to 10 (agonizing pain). Mean device-related pain score did not differ significantly between the 2 groups, with scores of 0.6 and 0.7 for the RAVI guide and speculum groups, respectively. The rate of significant pain (score of ≥2) was twice as high in the speculum group (7 of 22, 32%) compared with the RAVI guide group (5 of 32, 16%), but this difference was not statistically significant (P = 0.19, Fisher's exact test). Operative goals of avoiding needle touch to lashes/lids and guiding needle insertion to the intended site were achieved in all patients. The RAVI guide appeared equivalent to the eyelid speculum in achieving operative goals, with similarly low pain scores. It has the potential for facilitating efficient, accurate, and safe intravitreal injections.

Optimizing drug therapy in patients with cardiovascular disease: the impact of pharmacist-managed pharmacotherapy clinics in a primary care setting.

PubMed

Geber, Jean; Parra, David; Beckey, Nick P; Korman, Lisa

2002-06-01

We evaluated the effectiveness of pharmacist-managed pharmacotherapy clinics in implementing and maximizing therapy with agents known to reduce the morbidity and mortality associated with cardiovascular disease. This was a retrospective chart review of 150 patients who were treated for coronary artery disease in primary care clinics. Appropriate treatment of hypercholesterolemia occurred in 96% of patients referred to a clinical pharmacy specialist, compared with 68% of those followed by primary care providers alone (p<0.0001). Eighty-five percent and 50%, respectively, achieved goal low-density lipoprotein (LDL) values below 105 mg/dl (p<0.0001). Appropriate therapy with aspirin or other antiplatelet or anticoagulant drugs was prescribed in 97% and 92%, respectively (p=0.146). As appropriate therapy with these agents was high in both groups, the ability to detect a difference between groups was limited. Among patients with an ejection fraction below 40%, appropriate therapy with an angiotensin-converting enzyme inhibitor or acceptable alternative was 89% and 69%, respectively (p<0.05). Twenty-seven cardiac events were documented in the clinical pharmacy group, versus 22 in the primary care group (p=0.475). Despite the relatively high percentage of patients reaching goal LDL in the primary care group, referral to clinical pharmacy specialists resulted in statistically significant increases in the number of patients appropriately treated for hypercholesterolemia and achieving goal LDL.

Preoperative PROMIS Scores Predict Postoperative Success in Foot and Ankle Patients.

PubMed

Ho, Bryant; Houck, Jeff R; Flemister, Adolph S; Ketz, John; Oh, Irvin; DiGiovanni, Benedict F; Baumhauer, Judith F

2016-09-01

The use of patient-reported outcomes continues to expand beyond the scope of clinical research to involve standard of care assessments across orthopedic practices. It is currently unclear how to interpret and apply this information in the daily care of patients in a foot and ankle clinic. We prospectively examined the relationship between preoperative patient-reported outcomes (PROMIS Physical Function, Pain Interference and Depression scores), determined minimal clinical important differences for these values, and assessed if these preoperative values were predictors of improvement after operative intervention. Prospective collection of all consecutive patient visits to a multisurgeon tertiary foot and ankle clinic was obtained between February 2015 and April 2016. This consisted of 16 023 unique visits across 7996 patients, with 3611 new patients. Patients undergoing elective operative intervention were identified by ICD-9 and CPT code. PROMIS physical function, pain interference, and depression scores were assessed at initial and follow-up visits. Minimum clinically important differences (MCIDs) were calculated using a distribution-based method. Receiver operating characteristic (ROC) curves were calculated to determine whether preoperative PROMIS scores were predictive of achieving MCID. Cutoff values for PROMIS scores that would predict achieving MCID and not achieving MCID with 95% specificity were determined. Prognostic pre- and posttest probabilities based off these cutoffs were calculated. Patients with a minimum of 7-month follow-up (mean 9.9) who completed all PROMIS domains were included, resulting in 61 patients. ROC curves demonstrated that preoperative physical function scores were predictive of postoperative improvement in physical function (area under the curve [AUC] 0.83). Similarly, preoperative pain interference scores were predictive of postoperative pain improvement (AUC 0.73) and preoperative depression scores were also predictive of postoperative depression improvement (AUC 0.74). Patients with preoperative physical function T score below 29.7 had an 83% probability of achieving a clinically meaningful improvement in function as defined by MCID. Patients with preoperative physical function T score above 42 had a 94% probability of failing to achieve MCID. Patients with preoperative pain above 67.2 had a 66% probability of achieving MCID, whereas patients with preoperative pain below 55 had a 95% probability of failing to achieve MCID. Patients with preoperative depression below 41.5 had a 90% probability of failing to achieve MCID. Patient-reported outcomes (PROMIS) scores obtained preoperatively predicted improvement in foot and ankle surgery. Threshold levels in physical function, pain interference, and depression can be shared with patients as they decide whether surgery is a good option and helps place a numerical value on patient expectations. Physical function scores below 29.7 were likely to improve with surgery, whereas those patients with scores above 42 were unlikely to make gains in function. Patients with pain scores less than 55 were similarly unlikely to improve, whereas those with scores above 67 had clinically significant pain reduction postoperatively. Reported prognostic cutoff values help to provide guidance to both the surgeon and the patient and can aid in shared decision making for treatment. Level II, prognostic study. © The Author(s) 2016.

EUS-directed Transgastric ERCP (EDGE) Versus Laparoscopy-assisted ERCP (LA-ERCP) for Roux-en-Y Gastric Bypass (RYGB) Anatomy: A Multicenter Early Comparative Experience of Clinical Outcomes.

PubMed

Kedia, Prashant; Tarnasky, Paul R; Nieto, Jose; Steele, Stephen L; Siddiqui, Ali; Xu, Ming-Ming; Tyberg, Amy; Gaidhane, Monica; Kahaleh, Michel

2018-04-17

The standard of care for managing pancreaticobiliary disease in altered Roux-en-Y gastric bypass patients is laparoscopy-assisted endoscopic retrograde cholangiopancreatography (LA-ERCP), but is limited by cost and adverse events. Recently a minimally invasive, completely endoscopic approach using endoscopic ultrasound (EUS) directed transgastric ERCP (EDGE) has been described. We aim to compare EDGE to LA-ERCP in this study. Patients from May 2005 to June 2017 with Roux-en-Y gastric bypass anatomy having undergone LA-ERCP or EDGE at 4 tertiary centers were captured in a registry. Patient demographics, procedural details, and clinical outcomes were measured for each group. Seventy-two patients (n=29 EDGE, n=43 LA-ERCP) were included in this study. There was no significant difference in the technical success of EDGE gastrogastric fistula (96.5%) versus LA-gastrostomy creation (100%). The success rate of achieving therapeutic ERCP (EDGE 96.5% vs. LA-ERCP 97.7%) and number of ERCP (EDGE 1.2 vs. LA-ERCP 1.02) needed to achieve clinical resolution was similar between both groups. Adverse event rate for EDGE, 24% (7/29) and LA-ERCP, 19% (8/43) was similar. The total procedure time (73 vs. 184 min) and length of hospital stay (0.8 vs. 2.65 d) was significantly shorter for EDGE compared to LA-ERCP. The overall weight change after EDGE was -6.6 lbs at an average 28-week follow-up. This study suggests that the EDGE procedure has similar technical success and adverse events compared with LA-ERCP with the benefit of significantly shorter procedure times and hospital stay. EDGE may offer a minimally invasive, effective option, with less resource utilization, and without significant weight gain.

Assessing the role of a medication-indication resource in the treatment relation extraction from clinical text

PubMed Central

Bejan, Cosmin Adrian; Wei, Wei-Qi; Denny, Joshua C

2015-01-01

Objective To evaluate the contribution of the MEDication Indication (MEDI) resource and SemRep for identifying treatment relations in clinical text. Materials and methods We first processed clinical documents with SemRep to extract the Unified Medical Language System (UMLS) concepts and the treatment relations between them. Then, we incorporated MEDI into a simple algorithm that identifies treatment relations between two concepts if they match a medication-indication pair in this resource. For a better coverage, we expanded MEDI using ontology relationships from RxNorm and UMLS Metathesaurus. We also developed two ensemble methods, which combined the predictions of SemRep and the MEDI algorithm. We evaluated our selected methods on two datasets, a Vanderbilt corpus of 6864 discharge summaries and the 2010 Informatics for Integrating Biology and the Bedside (i2b2)/Veteran's Affairs (VA) challenge dataset. Results The Vanderbilt dataset included 958 manually annotated treatment relations. A double annotation was performed on 25% of relations with high agreement (Cohen's κ = 0.86). The evaluation consisted of comparing the manual annotated relations with the relations identified by SemRep, the MEDI algorithm, and the two ensemble methods. On the first dataset, the best F1-measure results achieved by the MEDI algorithm and the union of the two resources (78.7 and 80, respectively) were significantly higher than the SemRep results (72.3). On the second dataset, the MEDI algorithm achieved better precision and significantly lower recall values than the best system in the i2b2 challenge. The two systems obtained comparable F1-measure values on the subset of i2b2 relations with both arguments in MEDI. Conclusions Both SemRep and MEDI can be used to extract treatment relations from clinical text. Knowledge-based extraction with MEDI outperformed use of SemRep alone, but superior performance was achieved by integrating both systems. The integration of knowledge-based resources such as MEDI into information extraction systems such as SemRep and the i2b2 relation extractors may improve treatment relation extraction from clinical text. PMID:25336593

Students' Reflections on the Relationships between Safe Learning Environments, Learning Challenge and Positive Experiences of Learning in a Simulated GP Clinic

ERIC Educational Resources Information Center

Young, J. E.; Williamson, M. I.; Egan, T. G.

2016-01-01

Learning environments are a significant determinant of student behaviour, achievement and satisfaction. In this article we use students' reflective essays to identify key features of the learning environment that contributed to positive and transformative learning experiences. We explore the relationships between these features, the students'…

Clinical-academic partnerships research: converting the rhetoric into reality.

PubMed

Happell, Brenda

2005-09-01

An increasing recognition of the importance of research-based practice to the nursing profession has led to a number of strategies designed to increase the utilization and conduct of nursing research. The transfer of nursing education from hospitals to universities occurred partly in response to the identified theory-practice gap. Subsequently, a significant investment in joint clinical-academic positions and clinical professorial positions has been made with the intention of bridging the gap between the tertiary sector and the clinical field. Anecdotal evidence suggests that neither strategy has achieved the desired degree of success. The available literature suggests that nurses do not tend to become involved in the conduct of research, nor do they readily utilise research findings in their practice. It is hypothesized in this paper that this reflects the strong cultural differences between the clinical and academic worlds in nursing. The aim of this paper is to discuss the impact of these cultural differences and describe specific principals that could contribute to significant cultural change and the bridging of the academic-clinician divide.

A Hairy Situation: Laser Hair Removal after Oral Reconstruction.

PubMed

Shields, Bridget E; Moye, Molly S; Bayon, Rodrigo; Sperry, Steven M; Wanat, Karolyn A

2018-03-01

To present a case series of 4 patients who underwent postoperative hair removal using the long-pulsed Alexandrite or Nd:YAG laser following intraoral cutaneous flap reconstruction. Patients underwent epilation in dermatology clinic with long-pulsed Alexandrite or Nd:YAG lasers, spaced 8 weeks apart, until hair removal was achieved. All patients achieved improvement in hair removal regardless of initial flap donor site with significant improvement in quality of life and minimal side effects. The long-pulsed Alexandrite and Nd:YAG represent safe and effective treatment options to improve patient quality of life following intraoral flap repair following excision of malignancy.

Comparison of conventional L-thyroxine withdrawal and moderate hypothyroidism in preparation for whole-body 131-I scan and thyroglobulin testing.

PubMed

Marturano, I; Russo, M; Spadaro, A; Latina, A; Malandrino, P; Regalbuto, C

2015-09-01

After thyroidectomy for thyroid cancer, patients often withdraw L-T4 for diagnostic or therapeutic purposes, showing signs and symptoms of hypothyroidism. A slighter hypothyroidism (reducing L-T4 to one-half) has been proposed to limit these inconveniences. We evaluated half-dose L-T4 protocol, in comparison to conventional L-T4 withdrawal, in terms of effectiveness and improvement of clinical and biochemical disorders. We randomized 55 thyroid cancer patients into two groups: 29 patients underwent 5 weeks of half-dose of previous L-T4 treatment (HD group); 26 patients replaced L-T4 with L-T3 for 3 weeks followed by 2 weeks of withdrawal (TW group). Clinical features (Zulewsky clinical score) and biochemical parameters (lipids, liver, and muscle enzymes) were evaluated in all patients at baseline and after 5 weeks. Total cholesterol, creatine kinase, lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase increased at 5 weeks in both groups, but significantly more in TW, but no difference was found by clinical score. Patients who achieved the thyroid-stimulating hormone (TSH) target value (25 µU/ml) were 92.3% in TW group and 48.3% in HD group (p < 0.001). In the HD group, only basal TSH statistically correlated with the achievement of the TSH target. Receiver operating characteristic curves indicated that a basal TSH ≥0.52 μU/ml is required to reach an adequate TSH level. Half-dose L-T4 protocol, compared to conventional L-T4 withdrawal, is associated with less biochemical disorders but no significant clinical advantage. Therefore, the half-dose protocol reaches an adequate TSH target in 48.3% of patients and is not effective unless basal serum TSH is ≥0.52 μU/ml.

Clinical inertia in type 2 diabetes: A retrospective analysis of pharmacist-managed diabetes care vs. usual medical care

PubMed Central

Yam, Felix K.; Adams, Aimee G.; Divine, Holly; Steinke, Douglas; Jones, Mikael D.

Background Evidence suggests that patients with type 2 diabetes (T2DM) suffer from a high rate of “clinical inertia” or “recognition of the problem but failure to act.” Objective The aim of this study is to quantify the rate of clinical inertia between two models of care: Pharmacist-Managed Diabetes Clinic (PMDC) vs. Usual Medical Care (UMC). Methods Patients in a university based medical clinic with type 2 diabetes (T2DM) were analyzed in this retrospective cohort study. Patients were exposed to either PMDC or UMC. The difference in days to intervention in response to suboptimal laboratory values and time to achieve goal hemoglobin A1c (A1c), systolic blood pressure (SBP) and low-density lipoprotein (LDL) was compared in the two models of care. Results A total of 113 patients were included in the analysis of this study, 54 patients were in the PMDC and 59 patients were in the UMC group. Median time (days) to intervention for A1c values >7% was 8 days and 9 days in the PMDC and UMC groups, respectively (p>0.05). In patients with baseline A1c values >8%, median time to achieving A1c<7% was 259 days vs. 403 days in the PMDC and UMC groups, respectively (p<0.05). Median time to goal SBP was 124 days in the PMDC group and 532 days in the UMC group (p<0.05). Median time to goal LDL was 412 days in the PMDC group vs. 506 days in the UMC group (p<0.05). Conclusions Rates of clinical inertia, defined as time to intervention of suboptimal clinical values, did not differ significantly between patients enrolled in a PMDC compared to patients with UMC with respect to A1c, SBP and LDL. Participation in PMDC, however, was associated with achieving goal A1c, SBP, and LDL levels sooner compared to UMC. PMID:24367460

Effects of using the developing nurses' thinking model on nursing students' diagnostic accuracy.

PubMed

Tesoro, Mary Gay

2012-08-01

This quasi-experimental study tested the effectiveness of an educational model, Developing Nurses' Thinking (DNT), on nursing students' clinical reasoning to achieve patient safety. Teaching nursing students to develop effective thinking habits that promote positive patient outcomes and patient safety is a challenging endeavor. Positive patient outcomes and safety are achieved when nurses accurately interpret data and subsequently implement appropriate plans of care. This study's pretest-posttest design determined whether use of the DNT model during 2 weeks of clinical postconferences improved nursing students' (N = 83) diagnostic accuracy. The DNT model helps students to integrate four constructs-patient safety, domain knowledge, critical thinking processes, and repeated practice-to guide their thinking when interpreting patient data and developing effective plans of care. The posttest scores of students from the intervention group showed statistically significant improvement in accuracy. Copyright 2012, SLACK Incorporated.

Classification of clinical significance of MRI prostate findings using 3D convolutional neural networks

NASA Astrophysics Data System (ADS)

Mehrtash, Alireza; Sedghi, Alireza; Ghafoorian, Mohsen; Taghipour, Mehdi; Tempany, Clare M.; Wells, William M.; Kapur, Tina; Mousavi, Parvin; Abolmaesumi, Purang; Fedorov, Andriy

2017-03-01

Prostate cancer (PCa) remains a leading cause of cancer mortality among American men. Multi-parametric magnetic resonance imaging (mpMRI) is widely used to assist with detection of PCa and characterization of its aggressiveness. Computer-aided diagnosis (CADx) of PCa in MRI can be used as clinical decision support system to aid radiologists in interpretation and reporting of mpMRI. We report on the development of a convolution neural network (CNN) model to support CADx in PCa based on the appearance of prostate tissue in mpMRI, conducted as part of the SPIE-AAPM-NCI PROSTATEx challenge. The performance of different combinations of mpMRI inputs to CNN was assessed and the best result was achieved using DWI and DCE-MRI modalities together with the zonal information of the finding. On the test set, the model achieved an area under the receiver operating characteristic curve of 0.80.

[Sheng's acupuncture manipulation at bone-nearby acupoints and the academic thoughts].

PubMed

Sheng, Ji-li; Jin, Xiao-qing

2014-11-01

Sheng's acupuncture manipulation at bone-nearby acupoints is a set of needling manipulation of the chief physician of TCM, SHENG Xie-sun, summarized through his over 50 years clinical experiences and on the basis of Internal Classic. Regarding this manipulation, on the premise of acupoint selection based on syndrome differentiation, the acupoints close to bone are possibly selected and punctured, with the needle tip toward bone edge, and followed by the technique to achieve reducing purpose. Clinically, the significant immediate analgesia can be achieved in pain disorders such as headache and toothache. Professor Sheng thought, corresponding to the location of needle insertion and needling depth, the tissue layers of needle tip passing through should be considered specially. The site of needle insertion should be changeable so as to ensure the needle tip reaching the bone. This manipulation for analgesia provides a certain guide for acupuncture study, especially for the mechanism study on acupuncture analgesia.

Virtual reality in the treatment of body image disturbances after bariatric surgery: a clinical case.

PubMed

Riva, Giuseppe; Cárdenas-López, Georgina; Duran, Ximena; Torres-Villalobos, Gonzalo M; Gaggioli, Andrea

2012-01-01

Bariatric surgery is an operation on the stomach and/or intestines that helps patients with extreme obesity to lose weight. Even if bariatric surgery, compared with traditional obesity treatment, is more effective in reducing BMI, this approach does not achieve equal results in every patient. More, following bariatric surgery common problems are body image dissatisfaction and body disparagement: there is a significant difference between the weight loss clinicians consider successful (50% of excess weight) and the weight loss potential patients expect to achieve (at least 67% of the excess weight). The paper discusses the possible role of virtual reality (VR) in addressing this problem within an integrated treatment approach. More, the clinical case of a female bariatric patient who experienced body dissatisfaction even after a 30% body weight loss and a 62% excess body weight loss, is presented and discussed.

[Effectiveness and difficulty of education on nosocomial infection control for pre-clinical practice in the clinic, so-called inclusive clinical practice phase I, for students in the Faculty of Dentistry, Tokyo Medical and Dental University].

PubMed

Sunakawa, Mitsuhiro; Matsumoto, Hiroyuki

2009-03-01

It has been planned to give pre-clinical practice in the clinic, so-called inclusive clinical practice phase I, for fifth-grade students in the School of Dentistry, Faculty of Dentistry, Tokyo Medical and Dental University, to give them the clinical training needed to perform dental practice and clinical practicum for comprehensive patient care, namely inclusive clinical practice phase II. This study analyzed the educative efficiency of the class on nosocomial infection control (NIC) by comparing achievements pre- and post-test, and discussed appropriate education planning on the NIC for dental students. Sixty-two fifth-grade students in the 2007 academic year sat the pre- and post-tests; the mean score and standard deviation of these tests were 5.30 +/- 1.26 (n = 56) and 8.59 +/- 1.18 (n = 59), respectively. There was a statistically significant difference between them (paired t-test, p < 0.01). Another finding was that students with high scores in the post-test did not necessarily achieve high ratings in the pre-test. It is suggested that the introduction of pre- and post-tests and the clarification of main points in the class as a theme of NIC could be a useful tool for increasing the comprehension of students on the theme. Since students at lower grades will attend clinical practice in the university hospital, it is thought that students should be given NIC training early in the clinical course, and the current curriculum should be improved to increase the opportunity for students to study this important issue.

Predictive factors for structural remission using abatacept: results from the ABROAD study.

PubMed

Murakami, Kosaku; Sekiguchi, Masahiro; Hirata, Shintaro; Fujii, Takao; Matsui, Kiyoshi; Morita, Satoshi; Ohmura, Koichiro; Kawahito, Yutaka; Nishimoto, Norihiro; Mimori, Tsuneyo; Sano, Hajime

2018-05-29

To investigate the effect of abatacept (ABA) on preventing joint destruction in biological disease-modifying anti-rheumatic drug (bDMARD)-naïve rheumatoid arthritis (RA) patients in real-world clinical practice. RA patients were collected from the ABROAD (ABatacept Research Outcomes as a First-line Biological Agent in the Real WorlD) study cohort. They had moderate or high disease activity and were treated with ABA as a first-line bDMARD. Radiographic change between baseline and 1 year after ABA treatment was assessed with the van der Heijde's modified total Sharp score (mTSS). Predictive factors for structural remission (St-REM), defined as ΔmTSS ≤0.5/year, were determined. Among 118 patients, 81 (67.5%) achieved St-REM. Disease duration <3 years (odds ratio (OR) = 3.152, p = 0.007) and slower radiographic progression (shown as "baseline mTSS/year <3", OR = 3.727, p = 0.004) were independently significant baseline predictive factors for St-REM irrespective of age and sex. St-REM prevalence increased significantly if clinical remission based on the Simplified Disease Activity Index was achieved at least once until 24 weeks after ABA treatment. Shorter disease duration, smaller radiographic progression at baseline, and rapid clinical response were predictive factors for sustained St-REM after ABA therapy in bDMARD-naïve RA patients.

Review of mitral valve insufficiency: repair or replacement

PubMed Central

Madesis, Athanasios; Tsakiridis, Kosmas; Katsikogiannis, Nikolaos; Machairiotis, Nikolaos; Kougioumtzi, Ioanna; Kesisis, George; Tsiouda, Theodora; Beleveslis, Thomas; Koletas, Alexander; Zarogoulidis, Konstantinos

2014-01-01

Mitral valve (MV) dysfunction is the second-most common clinically significant form of valvular defect in adults. MV regurgitation occurs with the increasing frequency of degenerative changes of the aging process. Moreover, other causes of clinically significant MV regurgitation include cardiac ischemia, infective endocarditis and rhematic disease more frequently in less developed countries. Recent evidence suggests that the best outcomes after repair of severe degenerative mitral regurgitation (MR) are achieved in asymptomatic or minimally symptomatic patients, who are selected for surgery soon after diagnosis on the basis of echocardiography. This review will focus on the surgical management of mitral insufficiency according to its aetiology today and will give insight to some of the perspectives that lay in the future. PMID:24672698

[Modern technologies and prospects of rehabilitation of patients after ischemic stroke].

PubMed

Ekusheva, E V

Despite the great achievements in the field of neurorehabilitation, a significant proportion of patients after an ischemic stroke have persistent motor disturbances even after timely and adequately carried out restorative measures. The article discusses the issues of neuroplasticity, modern diagnostic technologies for studying this phenomenon; prognostic factors for recovery deficit following stroke and determining the effectiveness of ongoing treatment. The principles of neuroprotective therapy in ischemic stroke are considered, which is a pathogenetically justified direction at all stages of restorative treatment after cerebral circulation disorders. One of the most studied original cytoprotectors, demonstrating safety, efficacy and good tolerability, is cytoflavin. The results of numerous clinical trials have revealed a significant positive clinical and morphological dynamics when taking cytoflavin in patients after ischemic stroke.

Research and application of absorbable screw in orthopedics: a clinical review comparing PDLLA screw with metal screw in patients with simple medial malleolus fracture.

PubMed

Tang, Jin; Hu, Jin-feng; Guo, Wei-chun; Yu, Ling; Zhao, Sheng-hao

2013-01-01

To observe the therapeutic effect of absorbable screw in medial malleolus fracture and discuss its clinical application in orthopedics. A total of 129 patients with simple medial malleolus fracture were studied. Among them, 64 patients were treated with poly-D, L-lactic acid (PDLLA) absorbable screws, while the others were treated with metal screws. All the patients were followed up for 12-20 months (averaged 18.4 months) and the therapeutic effect was evaluated according to the American Orthopaedic Foot and Ankle Society clinical rating systems. In absorbable screw group, we obtained excellent and good results in 62 cases (96.88%); in steel screw group, 61 cases (93.85%) achieved excellent and good results. There was no significant difference between the two groups. In the treatment of malleolus fracture, absorbable screw can achieve the same result compared with metal screw fixation. Absorbable screw is preferred due to its advantages of safety, cleanliness and avoiding the removal procedure associated with metallic implants.

Evaluation of a pilot hypertension management programme for Guatemalan adults

PubMed Central

Mendoza Montano, Carlos; Fort, Meredith; deRamirez, Miriam; Cruz, Judith; Ramirez-Zea, Manuel

2016-01-01

Corazón Sano y Feliz is a hypertension management intervention developed to address deficiencies in the management of hypertensive patients in Guatemala. From 2007 to 2009, Corazón Sano y Feliz was pilot-tested in the community of Mixco. Corazón Sano y Feliz comprises a clinical risk assessment and treatment component implemented primarily by nurses, and a health education component implemented by community health workers. To accomplish our secondary objective of determining Corazon Sano y Feliz's potential for change at the patient level, we implemented a one-group pretest-posttest study design to examine changes in clinical measures, knowledge and practices between baseline and the end of the 6-month intervention. Two nurses and one physician set up a hypertension clinic to manage patients according to risk level. Twenty-nine community health workers were trained in CVD risk reduction and health promotion and in turn led six educational sessions for patients. Comparing baseline and 6-month measures, the intervention achieved significant improvements in mean knowledge and behaviour (increase from 54.6 to 59.1 out of a possible 70 points) and significant reductions of mean systolic and diastolic blood pressure (27.2 and 7.7 mmHg), body mass index (from 26.5 to 26.2 kg/m2) and waist circumference (89.6–88.9 cm). In this pilot study we obtained preliminary evidence that this community-oriented hypertension management and health promotion intervention model was feasible and achieved significant reduction in risk factors. If scaled up, this intervention has the potential to substantially reduce CVD burden. PMID:25595280

Breakthrough seizures—Further analysis of the Standard versus New Antiepileptic Drugs (SANAD) study

PubMed Central

Powell, Graham A.; Tudur Smith, Catrin; Marson, Anthony G.

2017-01-01

Objectives To develop prognostic models for risk of a breakthrough seizure, risk of seizure recurrence after a breakthrough seizure, and likelihood of achieving 12-month remission following a breakthrough seizure. A breakthrough seizure is one that occurs following at least 12 months remission whilst on treatment. Methods We analysed data from the SANAD study. This long-term randomised trial compared treatments for participants with newly diagnosed epilepsy. Multivariable Cox models investigated how clinical factors affect the probability of each outcome. Best fitting multivariable models were produced with variable reduction by Akaike’s Information Criterion. Risks associated with combinations of risk factors were calculated from each multivariable model. Results Significant factors in the multivariable model for risk of a breakthrough seizure following 12-month remission were number of tonic-clonic seizures by achievement of 12-month remission, time taken to achieve 12-month remission, and neurological insult. Significant factors in the model for risk of seizure recurrence following a breakthrough seizure were total number of drugs attempted to achieve 12-month remission, time to achieve 12-month remission prior to breakthrough seizure, and breakthrough seizure treatment decision. Significant factors in the model for likelihood of achieving 12-month remission after a breakthrough seizure were gender, age at breakthrough seizure, time to achieve 12-month remission prior to breakthrough, and breakthrough seizure treatment decision. Conclusions This is the first analysis to consider risk of a breakthrough seizure and subsequent outcomes. The described models can be used to identify people most likely to have a breakthrough seizure, a seizure recurrence following a breakthrough seizure, and to achieve 12-month remission following a breakthrough seizure. The results suggest that focussing on achieving 12-month remission swiftly represents the best therapeutic aim to reduce the risk of a breakthrough seizure and subsequent negative outcomes. This will aid individual patient risk stratification and the design of future epilepsy trials. PMID:29267375

Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study

PubMed Central

Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

2014-01-01

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community. PMID:25383173

An overview of clinical studies on fiber post systems.

PubMed

Dikbas, Idil; Tanalp, Jale

2013-01-01

Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis.

An Overview of Clinical Studies on Fiber Post Systems

PubMed Central

Dikbas, Idil; Tanalp, Jale

2013-01-01

Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis. PMID:24250255

Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

PubMed

Davies, Benjamin M; Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

2014-01-01

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

Geographic Proximity and Racial Disparities in Cancer Clinical Trial Participation

PubMed Central

Kanarek, Norma F.; Tsai, Hua-Ling; Metzger-Gaud, Sharon; Damron, Dorothy; Guseynova, Alla; Klamerus, Justin F.; Rudin, Charles M.

2011-01-01

This study assessed the effects of race and place of residence on clinical trial participation by patients seen at a designated NCI comprehensive cancer center. Clinical trial accrual to cancer case ratios were evaluated using a database of residents at the continental United States seen at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins from 2005 to 2007. Place of residence was categorized into 3 nonoverlapping geographic areas: Baltimore City, non–Baltimore City catchment area, and non–catchment area. Controlling for age, sex, county poverty level, and cancer site, significant race and place of residence differences were seen in therapeutic or nontherapeutic clinical trials participation. White non–Baltimore City catchment area residents, the designated reference group, achieved the highest participation rate. Although the test of interaction (control group compared with all others) was not significant, some race–geographic area group differences were detected. In therapeutic trials, most race–place of residence group levels were statistically lower and different from reference; in nontherapeutic trials, race-specific Baltimore City groups participated at levels similar to reference. Baltimore City residents had lower participation rates only in therapeutic trials, irrespective of race. County poverty level was not significant but was retained as a confounder. Place of residence and race were found to be significant predictors of participation in therapeutic and nontherapeutic clinical trials, although patterns differed somewhat between therapeutic and nontherapeutic trials. Clinical trial accruals are not uniform across age, sex, race, place of residence, cancer site, or trial type, underscoring that cancer centers must better understand their source patients to enhance clinical trial participation. PMID:21147901

Transcatheter vessel occlusion: angiographic results versus clinical success

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

Feldman, L.; Greenfield, A.J.; Waltman, A.C.

1983-04-01

A review was made of 219 transcatheter vessel occlusion procedures performed over a ten-year period for control of hemorrhage, tumor palliation, or blood supply redistribution prior to intra-arterial chemotherapy. Complete angiographic success was obtained in 85% of the procedures, with partial success in 8%; complete clinical success was achieved in 53% of patients, with partial success in 23%. the most satisfactory clinical results were obtained with hemorrhagic gastritis and pelvic trauma. Embolizations for duodenal ulcer hemorrhage and transhepatic variceal occlusion were the least clinically successful, although isobutyl-cyanoacrylate appeared to be a significant improvement in angiographic therapy for duodenal ulcer. Themore » overall complication rate was 13%, with one third of the complications clinically silent. These results indicate that transcatheter vessel occlusion is a relatively safe and effective method for control of hemorrhage or tumor infarction.« less

Gender Issues in Gifted Achievement: Are Girls Making Inroads While Boys Fall Behind?

ERIC Educational Resources Information Center

Rimm, Sylvia B.

2015-01-01

School and life achievement patterns for girls and women differ from those of boys and men. While girls have made dramatic progress in school, they need to be inspired to connect to lifelong achievement. Both research and clinical work at the Ohio-based Family Achievement Clinic find that more boys than girls underachieve in school. There is much…

Positive outcomes influence the rate and time to publication, but not the impact factor of publications of clinical trial results.

PubMed

Suñé, Pilar; Suñé, Josep Maria; Montoro, J Bruno

2013-01-01

Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved), negative (when no statistical significance was achieved or it favored control drug) and descriptive (for non-controlled studies). Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785). Study results were identified for 68·9% of all completed clinical trials (541/785). Publication rate was 84·9% (180/212) for studies with results classified as positive and 68·9% (128/186) for studies with results classified as negative (p<0·001). Median time to publication was 2·09 years (IC95 1·61-2·56) for studies with results classified as positive and 3·21 years (IC95 2·69-3·70) for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55-2·55). No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141-28·409) and negative result studies (median 8·266, interquartile range: 4·135-17·157). Clinical trials with positive outcomes have significantly higher rates and shorter times to publication than those with negative results. However, no differences have been found in terms of impact factor.

Examining the role of technology in learning: an evaluation of online clinical conferencing.

PubMed

Cooper, Cathy; Taft, Lois B; Thelen, Mary

2004-01-01

The rapidly expanding use of instructional technology requires faculty openness to new teaching and learning situations. This study compared two instructional methods of conducting clinical conferences for baccalaureate nursing students: online versus face-to-face. Quantitative and qualitative data were collected from 77 students in 10 clinical sections of a senior capstone nursing course. Mean scores for all 11 items on the clinical evaluation tool were higher for students who had conferences online than those in face-to-face conferences. Four of the 11 items were statistically significant, reflecting greater participation and convenience for online participants. Online students also reported greater opportunities to reflect on ethical issues. There were no significant differences in quiz scores between the groups when students were tested on content covered in their clinical conferences. Students identified advantages including opportunities for flexibility and equal participation. Barriers included unfamiliarity with technology and lack of face-to-face-contact. The findings suggest that students can successfully achieve the intended purpose of clinical conferences through an online instructional technique. Ongoing research in the use of technology is necessary to meet student needs, enhance student learning, and support evidence-based practice in nursing education.

Can the multiple mini-interview predict academic achievement in medical school?

PubMed

Kim, Ja Kyoung; Kang, Seok Hoon; Lee, Hee Jae; Yang, JeongHee

2014-09-01

The purpose of this study was to determine whether the multiple mini-interview (MMI) predicts academic achievement for subjects in a medical school curriculum. Of 49 students who were admitted in 2008, 46 students finished the entire medical education curriculum within 4 years. We calculated the Pearson correlation coefficients between the total MMI score of the 46 graduates and their academic achievements in all subjects of the curriculum. The correlation coefficients between total MMI score and academic achievement in Medical Interview and History Taking, Problem-Based Learning, Doctoring I, and Clinical Practice of Surgery ranged from 0.4 to 0.7, indicating that they were moderately related. The values between total MMI score and achievement in Research Overview, Technical and Procedural Skills, Clinical Performance Examinations 1 and 3, Clinical Practice of Laboratory Medicine and Psychiatry, Neurology, and Orthopedics ranged from 0.2 to 0.4, which meant that they were weakly related. MMI score can predict medical student' academic achievement in subjects in the medical humanities and clinical practice.

Applications of PET CT in clinical practice: Present and future

NASA Astrophysics Data System (ADS)

Costa, Durval Campos

2007-02-01

Radionuclide imaging and specially positron emission tomography (PET) has already demonstrated its benefits in three major medical subjects, i.e. neurology, cardiology and particularly clinical oncology. More recently the combination of PET and X-ray computed tomography (CT) as PET-CT led to a significant increment of the already large number of clinical applications of this imaging modality. This "anatomy-metabolic fusion" also known as Metabolic Imaging has its future assured if we can: (1) improve resolution reducing partial volume effect, (2) achieve very fast whole body imaging, (3) obtain accurate quantification of specific functions with higher contrast resolution and, if possible, (4) reduce exposure rates due to the unavoidable use of ionizing radiation.

Rapid response to vedolizumab therapy in biologic-naïve patients with inflammatory bowel diseases.

PubMed

Feagan, Brian G; Lasch, Karen; Lissoos, Trevor; Cao, Charlie; Wojtowicz, Abigail M; Khalid, Javaria Mona; Colombel, Jean-Frédéric

2018-05-29

Vedolizumab, a humanized monoclonal antibody against α4β7 integrin, is used to treat adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). We investigated the time course of clinical response to vedolizumab in patients who were and were not previously treated with tumor necrosis factor (TNF) antagonists. We performed a post-hoc analysis of data from phase 3, randomized, controlled trials of vedolizumab vs placebo in adult patients with UC (n=374) or CD (n=784). We collected data on patient-reported symptoms (rectal bleeding and stool frequency for patients with UC, abdominal pain and loose stool frequency for patients with CD) reported at weeks 2, 4, and 6 of treatment. We reported mean percentage score changes from baseline and proportions of patients who achieved predefined scores. We performed multivariate logistic regression analysis to identify factors associated with an early response (at week 2). In patients with UC (overall or naïve to TNF antagonist therapy), a significantly greater percentage of patients given vedolizumab achieved the predefined composite symptom score at weeks 2, 4, and 6 compared to those given placebo. In patients with CD who were naïve to TNF antagonists, a significantly greater percentage of patients given vedolizumab achieved the predefined score at weeks 2 and 4 compared to those given placebo. Among patients with UC given vedolizumab, 19.1% (overall) and 22.3% (TNF antagonist naïve) achieved a composite score of rectal bleeding of 0 and stool frequency ≤1 at week 2 compared to 10% (overall) and 6.6% (TNF antagonist naïve) of those receiving placebo. Among TNF antagonist-naïve patients with CD, 15.0% of those given vedolizumab achieved an average daily composite score of abdominal pain ≤1 and loose stool frequency ≤3 at week 2 (compared to 7.9% given placebo), and 23.8% of those given vedolizumab achieved these by week 4 (compared to 10.3% given placebo). In a post-hoc analysis of data from phase 3 clinical trials, vedolizumab significantly improved patient-reported symptoms of UC and CD as early as week 2 of treatment, continuing through the first 6 weeks-especially when given as first-line biologic therapy. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Long-term far-transfer effects of working memory training in children with ADHD: a randomized controlled trial.

PubMed

Bigorra, Aitana; Garolera, Maite; Guijarro, Silvina; Hervás, Amaia

2016-08-01

ADHD affects working memory (WM) and other executive functions (EFs) and thereby negatively impacts school performance, clinical symptoms and functional impairment. The main aim of this study was to analyse the efficacy of computerized WM training (CWMT) on EF rating scales. A secondary objective was to assess its efficacy on performance-based measures of EF (PBMEF), learning, clinical symptoms and functional impairment. 66 children with combined-type ADHD between 7 and 12 years of age from the Child and Adolescent Psychiatric Unit (Spain) were included in this randomized, double-blind, placebo-controlled, parallel-group clinical trial. The participants were randomized (1:1) to an experimental group (EG) (CWMT) (n = 36) or a control group (CG) (placebo training). Assessments were conducted at baseline (T0), 1-2 weeks (T1), and 6 months post-intervention (T2) with the administration of EF rating scales, PBMEF, measures of academic achievement, and questionnaires regarding clinical symptoms and functional impairment. Participants, parents, teachers and professionals who performed the cognitive assessments were blinded. Adjusted multiple linear regression analysis showed significant improvements in EF scales-parent version, from T1 to T2, on the metacognition index [p = 0.03, d' = -0.78 (95 % CI -1.28 to -0.27)] and on WM (also significant at T2-T0) and plan/organize subscales. Significant improvements were also noted in EF scales-teacher version, from T0 to T1 and T2, on the metacognitive index [p = 0.05, d' = -0.37 (95 % CI -0.86 to 0.12) T1-T0, p = 0.02, d' = -0.81 (95 % CI -1.31 to -0.30) T2-T0] and on the initiate, WM, monitor and shift subscales. There were also significant improvements in PBMEF, ADHD symptoms, and functional impairment. CWMT had a significant impact on ADHD deficits by achieving long-term far-transfer effects.

Value-based payment in implementing evidence-based care: the Mental Health Integration Program in Washington state.

PubMed

Bao, Yuhua; McGuire, Thomas G; Chan, Ya-Fen; Eggman, Ashley A; Ryan, Andrew M; Bruce, Martha L; Pincus, Harold Alan; Hafer, Erin; Unützer, Jürgen

2017-01-01

To assess the role of value-based payment (VBP) in improving fidelity and patient outcomes in community implementation of an evidence-based mental health intervention, the Collaborative Care Model (CCM). Retrospective study based on a natural experiment. We used the clinical tracking data of 1806 adult patients enrolled in a large implementation of the CCM in community health clinics in Washington state. VBP was initiated in year 2 of the program, creating a natural experiment. We compared implementation fidelity (measured by 3 process-of-care elements of the CCM) between patient-months exposed to VBP and patient-months not exposed to VBP. A series of regressions were estimated to check robustness of findings. We estimated a Cox proportional hazard model to assess the effect of VBP on time to achieving clinically significant improvement in depression (measured based on changes in depression symptom scores over time). Estimated marginal effects of VBP on fidelity ranged from 9% to 30% of the level of fidelity had there been no exposure to VBP (P <.05 for every fidelity measure). Improvement in fidelity in response to VBP was greater among providers with a larger patient panel and among providers with a lower level of fidelity at baseline. Exposure to VBP was associated with an adjusted hazard ratio of 1.45 (95% confidence interval, 1.04-2.03) for achieving clinically significant improvement in depression. VBP improved fidelity to key elements of the CCM, both directly incentivized and not explicitly incentivized by the VBP, and improved patient depression outcomes.

Clinically Relevant Reduction in Persistent Facial Erythema of Rosacea on the First Day of Treatment With Oxymetazoline Cream 1.0.

PubMed

Tanghetti, Emil A; Dover, Jeffrey S; Goldberg, David J; Dhawan, Sunil S; Luo, Lei; Berk, David R; Ahluwalia, Gurpreet; Alvandi, Nancy

2018-06-01

Persistent facial erythema is a clinically challenging feature of rosacea. To evaluate persistent erythema reduction on the first day of treatment from pooled data from two pivotal trials of topical oxymetazoline cream 1.0% (oxymetazoline) in persistent facial erythema of rosacea. In two identically designed, phase 3, multicenter trials, adults with moderate to severe persistent facial erythema of rosacea (Clinician Erythema Assessment [CEA] grade ≥3 and Subject Self-Assessment [SSA] grade ≥3) were randomized 1:1 to once-daily topical oxymetazoline or vehicle; the primary efficacy endpoint was ≥2-grade composite CEA and SSA improvement from baseline on day 29. This post hoc analysis evaluated the proportion of patients achieving ≥1-grade composite and individual CEA and SSA improvement at 1, 3, 6, 9, and 12 hours postdose on day 1 (N=885). Significantly more patients achieved ≥1-grade composite and individual CEA and SSA improvement with the first application of oxymetazoline than with vehicle (P less than 0.001) at all postdose time points, beginning with hour 1. Day 1 safety assessments were similar between treatments. Short-term, post hoc analysis. A ≥1-grade improvement in persistent erythema achieved after the first dose of once-daily topical oxymetazoline demonstrated clinically meaningful improvement from the beginning of therapy. J Drugs Dermatol. 2018;17(6):621-626.

Interferon-targeted therapy in systemic lupus erythematosus: Is this an alternative to targeting B and T cells?

PubMed

Kalunian, K C

2016-09-01

Clinical trials of investigational agents in systemic lupus erythematosus (SLE) have focused on targeting dysregulated B and T cells; however, recent translational research findings of the importance of the dysregulation of the innate immune system in SLE have led to clinical trials that target interferon. Three biologics that target type I interferons have been tested for their efficacy and safety in active SLE patients; these phase II trials have tested the hypothesis that down-regulation of interferon-regulated gene expression (the interferon signature) lessen the clinical burden of SLE. Rontalizumab, an anti-interferon-α monoclonal antibody, was studied in patients who had discontinued immunosuppressants. This study failed to show efficacy as assessed by both two outcome assessments; however, in low interferon signature patients, response was higher and corticosteroid usage was less in rontalizumab-treated patients. Sifalimumab, another anti-interferon-α monoclonal antibody, was studied in patients who remained on standard of care therapy. This study showed significantly better efficacy in patients treated with two sifalimumab dosages; significant differences were seen in the high interferon signature group. In a similar design and in a similar population as the sifalimumab study, anifrolumab, a monoclonal antibody that binds to a type I interferon receptor, was studied in patients who remained on standard of care therapy. In this study, one dosage group demonstrated efficacy and statistically significant effects were achieved in both tested dosage groups with secondary end points. Oral corticosteroid reduction to ≤7.5 mg daily was achieved in one of the tested dosage groups and organ-specific outcomes were significantly improved in that same group. For all studies, no significant differences in serious adverse effects were seen; although, herpes zoster infections were increased in sifalimumab- and anifrolumab-treated patients and influenza rates were increased in anifrolumab-treated patients. Anifrolumab is currently in pivotal phase III studies. Data appear to support the concept that targeting type I interferon in SLE patients associates with clinical efficacy and safety. Further data are forthcoming from ongoing phase III clinical trials of anifrolumab. Other drug development efforts should be considered that target plasmacytoid dendritic cells and toll like receptors given the effects these components have on interferon production. © The Author(s) 2016.

Clinical outcome of acute nonvariceal upper gastrointestinal bleeding after hours: the role of urgent endoscopy.

PubMed

Ahn, Dong-Won; Park, Young Soo; Lee, Sang Hyub; Shin, Cheol Min; Hwang, Jin-Hyeok; Kim, Jin-Wook; Jeong, Sook-Hyang; Kim, Nayoung; Lee, Dong Ho

2016-05-01

This study was performed to investigate the clinical role of urgent esophagogastroduodenoscopy (EGD) for acute nonvariceal upper gastrointestinal bleeding (ANVUGIB) performed by experienced endoscopists after hours. A retrospective analysis was performed for consecutively collected data of patients with ANVUGIB between January 2009 and December 2010. A total of 158 patients visited the emergency unit for ANVUGIB after hours. Among them, 60 underwent urgent EGD (within 8 hours) and 98 underwent early EGD (8 to 24 hours) by experienced endoscopists. The frequencies of hemodynamic instability, fresh blood aspirate on the nasogastric tube, and high-risk endoscopic findings were significantly higher in the urgent EGD group. Primary hemostasis was achieved in all except two patients. There were nine cases of recurrent bleeding, and 30-day mortality occurred in three patients. There were no significant differences between the two groups in primary hemostasis, recurrent bleeding, and 30-day mortality. In a multiple linear regression analysis, urgent EGD significantly reduced the hospital stay compared with early EGD. In patients with a high clinical Rockall score (more than 3), urgent EGD tended to decrease the hospital stay, although this was not statistically significant (7.7 days vs. 12.0 days, p > 0.05). Urgent EGD after hours by experienced endoscopists had an excellent endoscopic success rate. However, clinical outcomes were not significantly different between the urgent and early EGD groups.

Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use.

PubMed

Takahashi, Nobunori; Fujibayashi, Takayoshi; Kida, Daihei; Hirano, Yuji; Kato, Takefumi; Kato, Daizo; Saito, Kiwamu; Kaneko, Atsushi; Yabe, Yuichiro; Takagi, Hideki; Oguchi, Takeshi; Miyake, Hiroyuki; Watanabe, Tsuyoshi; Hayashi, Masatoshi; Kanayama, Yasuhide; Funahashi, Koji; Hanabayashi, Masahiro; Hirabara, Shinya; Asai, Shuji; Takemoto, Toki; Terabe, Kenya; Asai, Nobuyuki; Yoshioka, Yutaka; Ishiguro, Naoki; Kojima, Toshihisa

2015-10-01

This observational retrospective study examined whether abatacept efficacy could be augmented with concomitant methotrexate (MTX) or tacrolimus (TAC) in patients with rheumatoid arthritis (RA) who experienced failure with prior biological disease-modifying antirheumatic drugs (DMARDs) and in whom favorable therapeutic efficacy is difficult to achieve. All patients with a prior biological DMARD history who were treated with abatacept for 52 weeks and registered in a Japanese multicentre registry were included. Clinical efficacy and safety of abatacept according to the concomitant drug used, i.e., none (ABT-mono), MTX (ABT-MTX), and TAC (ABT-TAC), were compared. A greater mean percent change of DAS28-ESR was observed in the ABT-TAC group compared with the ABT-mono group at weeks 12 (-20.5 vs. -5.4 %, p = 0.035) and 24 (-25.0 vs. -11.0 %, p = 0.036). ABT-MTX and ABT-TAC groups had a significantly higher proportion of patients who achieved low disease activity (LDA) within 52 weeks compared with the respective baselines, while no significant change was observed in the ABT-mono group. A higher proportion of patients in the ABT-TAC group achieved EULAR moderate response compared with the ABT-mono group at week 52 (66.7 vs. 35.0 %, p = 0.025). Multivariate logistic regression analysis revealed that concomitant TAC use was independently associated with the achievement of LDA and EULAR response at 52 weeks, while concomitant MTX use was not. Concomitant TAC use may offer a suitable option for RA patients treated with abatacept after prior biological DMARD failure, likely because both abatacept and TAC affect T cell activation.

Histological Validity and Clinical Evidence for Use of Fractional Lasers for Acne Scars

PubMed Central

Sardana, Kabir; Garg, Vijay K; Arora, Pooja; Khurana, Nita

2012-01-01

Though fractional lasers are widely used for acne scars, very little clinical or histological data based on the objective clinical assessment or the depth of penetration of lasers on in vivo facial tissue are available. The depth probably is the most important aspect that predicts the improvement in acne scars but the studies on histology have little uniformity in terms of substrate (tissue) used, processing and stains used. The variability of the laser setting (dose, pulses and density) makes comparison of the studies difficult. It is easier to compare the end results, histological depth and clinical results. We analysed all the published clinical and histological studies on fractional lasers in acne scars and analysed the data, both clinical and histological, by statistical software to decipher their significance. On statistical analysis, the depth was found to be variable with the 1550-nm lasers achieving a depth of 679 μm versus 10,600 nm (895 μm) and 2940 nm (837 μm) lasers. The mean depth of penetration (in μm) in relation to the energy used, in millijoules (mj), varies depending on the laser studied. This was statistically found to be 12.9–28.5 for Er:glass, 3–54.38 for Er:YAG and 6.28–53.66 for CO2. The subjective clinical improvement was a modest 46%. The lack of objective evaluation of clinical improvement and scar-specific assessment with the lack of appropriate in vivo studies is a case for combining conventional modalities like subcision, punch excision and needling with fractional lasers to achieve optimal results. PMID:23060702

Optimizing value utilizing Toyota Kata methodology in a multidisciplinary clinic.

PubMed

Merguerian, Paul A; Grady, Richard; Waldhausen, John; Libby, Arlene; Murphy, Whitney; Melzer, Lilah; Avansino, Jeffrey

2015-08-01

Value in healthcare is measured in terms of patient outcomes achieved per dollar expended. Outcomes and cost must be measured at the patient level to optimize value. Multidisciplinary clinics have been shown to be effective in providing coordinated and comprehensive care with improved outcomes, yet tend to have higher cost than typical clinics. We sought to lower individual patient cost and optimize value in a pediatric multidisciplinary reconstructive pelvic medicine (RPM) clinic. The RPM clinic is a multidisciplinary clinic that takes care of patients with anomalies of the pelvic organs. The specialties involved include Urology, General Surgery, Gynecology, and Gastroenterology/Motility. From May 2012 to November 2014 we performed time-driven activity-based costing (TDABC) analysis by measuring provider time for each step in the patient flow. Using observed time and the estimated hourly cost of each of the providers we calculated the final cost at the individual patient level, targeting clinic preparation. We utilized Toyota Kata methodology to enhance operational efficiency in an effort to optimize value. Variables measured included cost, time to perform a task, number of patients seen in clinic, percent value-added time (VAT) to patients (face to face time) and family experience scores (FES). At the beginning of the study period, clinic costs were $619 per patient. We reduced conference time from 6 min/patient to 1 min per patient, physician preparation time from 8 min to 6 min and increased Medical Assistant (MA) preparation time from 9.5 min to 20 min, achieving a cost reduction of 41% to $366 per patient. Continued improvements further reduced the MA preparation time to 14 min and the MD preparation time to 5 min with a further cost reduction to $194 (69%) (Figure). During this study period, we increased the number of appointments per clinic. We demonstrated sustained improvement in FES with regards to the families overall experience with their providers. Value added time was increased from 60% to 78% but this was not significant. Time-based cost analysis effectively measures individualized patient cost. We achieved a 69% reduction in clinic preparation costs. Despite this reduction in costs, we were able to maintain VAT and sustain improvements in family experience. In caring for complex patients, lean management methodology enables optimization of value in a multidisciplinary clinic. Copyright © 2015. Published by Elsevier Ltd.

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.

Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial.

PubMed

Giugliano, Robert P; Pedersen, Terje R; Park, Jeong-Gun; De Ferrari, Gaetano M; Gaciong, Zbigniew A; Ceska, Richard; Toth, Kalman; Gouni-Berthold, Ioanna; Lopez-Miranda, Jose; Schiele, François; Mach, François; Ott, Brian R; Kanevsky, Estella; Pineda, Armando Lira; Somaratne, Ransi; Wasserman, Scott M; Keech, Anthony C; Sever, Peter S; Sabatine, Marc S

2017-10-28

LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). In this prespecified secondary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up. We used multivariable modelling to adjust for baseline factors associated with achieved LDL cholesterol. This trial is registered with ClinicalTrials.gov, number NCT01764633. Between Feb 8, 2013, and June 5, 2015, 27 564 patients were randomly assigned a treatment in the FOURIER study. 1025 (4%) patients did not have an LDL cholesterol measured at 4 weeks and 557 (2%) had already had a primary endpoint event or one of the ten prespecified safety events before the week-4 visit. From the remaining 25 982 patients (94% of those randomly assigned) 13 013 were assigned evolocumab and 12 969 were assigned placebo. 2669 (10%) of 25 982 patients achieved LDL-cholesterol concentrations of less than 0·5 mmol/L, 8003 (31%) patients achieved concentrations between 0·5 and less than 1·3 mmol/L, 3444 (13%) patients achieved concentrations between 1·3 and less than 1·8 mmol/L, 7471 (29%) patients achieved concentrations between 1·8 to less than 2·6 mmol/L, and 4395 (17%) patients achieved concentrations of 2·6 mmol/L or higher. There was a highly significant monotonic relationship between low LDL-cholesterol concentrations and lower risk of the primary and secondary efficacy composite endpoints extending to the bottom first percentile (LDL-cholesterol concentrations of less than 0·2 mmol/L; p=0·0012 for the primary endpoint, p=0·0001 for the secondary endpoint). Conversely, no significant association was observed between achieved LDL cholesterol and safety outcomes, either for all serious adverse events or any of the other nine prespecified safety events. There was a monotonic relationship between achieved LDL cholesterol and major cardiovascular outcomes down to LDL-cholesterol concentrations of less than 0·2 mmol/L. Conversely, there were no safety concerns with very low LDL-cholesterol concentrations over a median of 2·2 years. These data support further LDL-cholesterol lowering in patients with cardiovascular disease to well below current recommendations. Amgen. Copyright © 2017 Elsevier Ltd. All rights reserved.

Trial of Early Aggressive Therapy in Polyarticular Juvenile Idiopathic Arthritis

PubMed Central

Wallace, Carol A.; Giannini, Edward H.; Spalding, Steven J.; Hashkes, Philip J.; O’Neil, Kathleen M.; Zeft, Andrew S.; Szer, Ilona S.; Ringold, Sarah; Brunner, Hermine I.; Schanberg, Laura E.; Sundel, Robert P.; Milojevic, Diana; Punaro, Marilynn G.; Chira, Peter; Gottlieb, Beth S.; Higgins, Gloria C.; Ilowite, Norman T.; Kimura, Yukiko; Hamilton, Stephanie; Johnson, Anne; Huang, Bin; Lovell, Daniel J.

2011-01-01

OBJECTIVES To determine if aggressive treatment initiated early in the course of rheumatoid factor positive or negative polyarticular juvenile idiopathic arthritis (poly-JIA) can induce clinical inactive disease (CID) within 6 months. METHODS Between May 2007 and October 2010 a multi-center, prospective, double blind, randomized, placebo controlled trial of two aggressive treatments was conducted in 85 children aged 2 to 16 years with polyarticular JIA of less than 12 months duration. Patients received either methotrexate 0.5 mg/kg/wk SQ (40 mg max), etanercept 0.8 mg/kg/wk (50 mg max), prednisolone 0.5 mg/kg/d (60 mg max) tapered to 0 by 17 weeks (Arm 1), or methotrexate (same dose as Arm 1), etanercept placebo, and prednisolone placebo (Arm 2). The primary outcome was CID at 6 months. An exploratory phase determined the rate of clinical remission on medication (6 months of continuous CID) at 12 months. RESULTS By 6 months, 17 of 42 (40%) of patients in Arm 1 and 10 of 43 (23%) in Arm 2 had achieved CID (X2 = 2.91; p = 0.088). After 12 months, 9 patients in Arm 1 and 3 in Arm 2 achieved clinical remission on medication (p = 0.0534). There were no significant inter-arm differences in adverse events. CONCLUSIONS Although this study did not meet its primary endpoint, early aggressive therapy in this cohort of children with recent onset polyarticular JIA resulted in substantial proportions of patients in both arms achieving CID by 6 months and clinical remission on medication within 12 months of treatment. PMID:22183975

Automatic motion correction of clinical shoulder MR images

NASA Astrophysics Data System (ADS)

Manduca, Armando; McGee, Kiaran P.; Welch, Edward B.; Felmlee, Joel P.; Ehman, Richard L.

1999-05-01

A technique for the automatic correction of motion artifacts in MR images was developed. The algorithm uses only the raw (complex) data from the MR scanner, and requires no knowledge of the patient motion during the acquisition. It operates by searching over the space of possible patient motions and determining the motion which, when used to correct the image, optimizes the image quality. The performance of this algorithm was tested in coronal images of the rotator cuff in a series of 144 patients. A four observer comparison of the autocorrelated images with the uncorrected images demonstrated that motion artifacts were significantly reduced in 48% of the cases. The improvements in image quality were similar to those achieved with a previously reported navigator echo-based adaptive motion correction. The results demonstrate that autocorrelation is a practical technique for retrospectively reducing motion artifacts in a demanding clinical MRI application. It achieves performance comparable to a navigator based correction technique, which is significant because autocorrection does not require an imaging sequence that has been modified to explicitly track motion during acquisition. The approach is flexible and should be readily extensible to other types of MR acquisitions that are corrupted by global motion.

Helminths and immunological tolerance.

PubMed

Johnston, Chris J C; McSorley, Henry J; Anderton, Stephen M; Wigmore, Stephen J; Maizels, Rick M

2014-01-27

Current immunosuppression regimens for solid-organ transplantation have shown disappointing efficacy in the prevention of chronic allograft rejection and carry unacceptable risks including toxicity, neoplasia, and life-threatening infection. Achievement of immunological tolerance (long-term antigen unresponsiveness in an immunocompetent host) presents the exciting prospect of freedom from immunosuppression for transplant recipients. It is now 60 years since the first demonstration of immunological tolerance in animal models of transplantation, but translation into routine clinical practice remains elusive. Helminth parasites may provide novel strategies toward achieving this goal. Helminths are remarkably successful parasites: they currently infect more than one quarter of the world's population. It is now well established that the parasites' success is the result of active immunomodulation of their hosts' immune response. Although this primarily secures ongoing survival of the parasites, helminth-induced immunomodulation can also have a number of benefits for the host. Significant reductions in the prevalence of allergy and autoimmune conditions among helminth-infected populations are well recognized and there is now a significant body of evidence to suggest that harmful immune responses to alloantigens may be abrogated as well. Here, we review all existing studies of helminth infection and transplantation, explore the mechanisms involved, and discuss possible avenues for future translation to clinical practice.

Personalized Hypertension Management Using Patient-Generated Health Data Integrated With Electronic Health Records (EMPOWER-H): Six-Month Pre-Post Study.

PubMed

Lv, Nan; Xiao, Lan; Simmons, Martha L; Rosas, Lisa G; Chan, Albert; Entwistle, Martin

2017-09-19

EMPOWER-H (Engaging and Motivating Patients Online With Enhanced Resources-Hypertension) is a personalized-care model facilitating engagement in hypertension self-management utilizing an interactive Web-based disease management system integrated with the electronic health record. The model is designed to support timely patient-provider interaction by incorporating decision support technology to individualize care and provide personalized feedback for patients with chronic disease. Central to this process were patient-generated health data, including blood pressure (BP), weight, and lifestyle behaviors, which were uploaded using a smartphone. The aim of this study was to evaluate the program among patients within primary care already under management for hypertension and with uncontrolled BP. Using a 6-month pre-post design, outcome measures included office-measured and home-monitored BP, office-measured weight, intervention contacts, diet, physical activity, smoking, knowledge, and health-related quality of life. At 6 months, 55.9% of participants (N=149) achieved office BP goals (<140/90 mm Hg; P<.001) and 86.0% achieved clinically meaningful reduction in office BP (reduction in systolic BP [SBP] ≥5 mm Hg or diastolic BP [DBP] ≥3 mm Hg). At baseline, 25.2% of participants met home BP goals (<135/85 mm Hg), and this percentage significantly increased to 71.4% (P<.001) at 6 months. EMPOWER-H also significantly reduced both office and home SBP and DBP, decreased office-measured weight and consumption of high-salt and high-fat foods (all P<.005), and increased intake of fruit and vegetables, minutes of aerobic exercise, and hypertension knowledge (all P<.05). Patients with higher home BP upload frequencies had significantly higher odds of achieving home BP goals. Patients receiving more total intervention, behavioral, pharmaceutical contacts had significantly lower odds of achieving home BP goals but higher improvements in office BP (all P<.05). EMPOWER-H significantly improved participants' office-measured and home-monitored BP, weight, and lifestyle behaviors, suggesting that technologically enabled BP home-monitoring, with structured use of patient-generated health data and a personalized care-plan facilitating patient engagement, can support effective clinical management. The experience gained in this study provides support for the feasibility and value of using carefully managed patient-generated health data in the day-to-day clinical management of patients with chronic conditions. A large-scale, real-world study to evaluate sustained effectiveness, cost-effectiveness, and scalability is warranted. ©Nan Lv, Lan Xiao, Martha L Simmons, Lisa G Rosas, Albert Chan, Martin Entwistle. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 19.09.2017.

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.

Overcoming regulatory and economic challenges facing pharmacogenomics.

PubMed

Cohen, Joshua P

2012-09-15

The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

Template-guided vs. non-guided drilling in site preparation of dental implants.

PubMed

Scherer, Uta; Stoetzer, Marcus; Ruecker, Martin; Gellrich, Nils-Claudius; von See, Constantin

2015-07-01

Clinical success of oral implants is related to primary stability and osseointegration. These parameters are associated with delicate surgical techniques. We herein studied whether template-guided drilling has a significant influence on drillholes diameter and accuracy in an in vitro model. Fresh cadaveric porcine mandibles were used for drilling experiments of four experimental groups. Each group consisted of three operators, comparing guide templates for drilling with free-handed procedure. Operators without surgical knowledge were grouped together, contrasting highly experienced oral surgeons in other groups. A total of 180 drilling actions were performed, and diameters were recorded at multiple depth levels, with a precision measuring instrument. Template-guided drilling procedure improved accuracy on a very significant level in comparison with free-handed drilling operation (p ≤ 0.001). Inaccuracy of free-handed drilling became more significant in relation to measurement depth. High homogenic uniformity of template-guided drillholes was significantly stronger than unguided drilling operations by highly experienced oral surgeons (p ≤ 0.001). Template-guided drilling procedure leads to significantly enhanced accuracy. Significant results compared to free-handed drilling actions were achieved, irrespective of the clinical experience level of the operator. Template-guided drilling procedures lead to a more predictable clinical diameter. It shows that any set of instruments has to be carefully chosen to match the specific implant system. The current in vitro study is implicating an improvement of implant bed preparation but needs to be confirmed in clinical studies.

The role of an NHS library service in the UK: the perceptions of clinical managers in Portsmouth, UK.

PubMed

Blagden, Pauline

2007-06-01

Portsmouth NHS Library Service is exploring methods of raising its profile within its host organization and wishes to demonstrate its contribution to achieving organizational goals, perhaps by means of an impact study. The objective of this small scale study, regarded as a possible precursor to an impact study, was to identify areas where there is potential to increase awareness among clinical managers of the Library's contribution. An e-mail survey was sent to clinical managers to elicit their opinions regarding the contribution of the Library Service to organizational goals. Perhaps unsurprisingly, the role of the Library Service in education, research and effectiveness was most widely recognized. Of responses, 30/42 (71%) rated it as 'very important' and a further 11 (26%) rated it as 'important'. The low appreciation of the Library Service to Clinical Services is a disappointment in view of the body of research evidence. Only 12 respondents (29%) thought that the Library Service contributed 'significantly' by 'supporting informed and timely clinical decision making'. The study suggested areas where there might be scope to raise awareness of the Library contribution. In considering how best to achieve this, the benefits need to be weighed against the resource implications. Portsmouth NHS Library Service decided to increase its marketing efforts but not to carry out an impact study in the short term.

Impact of the new 16-hour duty period on pediatric interns' neonatal education.

PubMed

DeLaroche, Amy; Riggs, Thomas; Maisels, M Jeffrey

2014-01-01

To assess the impact of the 16-duty hour restriction on pediatric interns' neonatal education. Survey of interns clinical and educational experiences during their neonatal rotations. A total of 316 respondents in 2011, who worked >16 hours, were compared with 509 respondents in 2012, who worked ≤16 hours. The average work week decreased from 67.3 ± 9.6 to 59.3 ± 8.1 hours (P < .0001). The 2012 cohort attended fewer didactic lectures (-16%, P < .0001), grand rounds (-27%, P < .0001), and mock resuscitations (-16%, P < .005). There were no significant differences in the number of (1) patients on service, (2) deliveries attended, or (3) procedures. There was no significant difference in the median number of correct responses (4) on 10 knowledge-based multiple-choice questions. The decrease in duty hours was achieved without significantly affecting interns' knowledge or clinical experience.

Safety and clinical efficacy of Onyx for embolization of extracranial head and neck vascular anomalies.

PubMed

Thiex, R; Wu, I; Mulliken, J B; Greene, A K; Rahbar, R; Orbach, D B

2011-01-01

Onyx was developed for embolization of central nervous system AVMs but is increasingly used extracranially because of its unique physical properties. We review our experience and results with the use of Onyx for the treatment of fast-flow extracranial vascular lesions. We retrospectively analyzed clinical and imaging records of 22 patients who underwent 71 extracranial embolizations from March 2007 through January 2010. The diagnoses were the following: cervicofacial AVM (n = 18), traumatic fistula (n = 3), and vessel laceration (n = 1). In 62 of 71 procedures (87%), Onyx was the sole embolic agent; it was delivered transarterially in 67/71 and percutaneously in 4/71 procedures. Clinical goals included amelioration of pain and control of bleeding. The clinical efficacy of embolization was judged by symptom control, and adverse events were assessed by clinical examination and history, both postembolization and 4 weeks postprocedure. Cessation of acute bleeding was achieved in 13/14 cases, with 1 case of immediate recurrent massive epistaxis prompting reintubation and further embolization. Control of subacute bleeding episodes and pain was achieved for all patients. Following staged embolization, 7 patients underwent surgical resection without significant blood loss. Surgeons reported high satisfaction with the intraoperative handling properties of Onyx. Transient swelling, local tenderness, or numbness was encountered after 7 procedures. There were no stuck catheters, vessel dissections, or vessel ruptures and no skin discoloration. Staged Onyx embolization was clinically efficacious in managing extracranial fast-flow vascular malformations and lesions, with low associated morbidity.

The Evolution of Neuroprosthetic Interfaces

PubMed Central

Adewole, Dayo O.; Serruya, Mijail D.; Harris, James P.; Burrell, Justin C.; Petrov, Dmitriy; Chen, H. Isaac; Wolf, John A.; Cullen, D. Kacy

2017-01-01

The ideal neuroprosthetic interface permits high-quality neural recording and stimulation of the nervous system while reliably providing clinical benefits over chronic periods. Although current technologies have made notable strides in this direction, significant improvements must be made to better achieve these design goals and satisfy clinical needs. This article provides an overview of the state of neuroprosthetic interfaces, starting with the design and placement of these interfaces before exploring the stimulation and recording platforms yielded from contemporary research. Finally, we outline emerging research trends in an effort to explore the potential next generation of neuroprosthetic interfaces. PMID:27652455

Learning styles and academic achievement among undergraduate medical students in Thailand.

PubMed

Jiraporncharoen, Wichuda; Angkurawaranon, Chaisiri; Chockjamsai, Manoch; Deesomchok, Athavudh; Euathrongchit, Juntima

2015-01-01

This study aimed to explore the associations between learning styles and high academic achievement and to ascertain whether the factors associated with high academic achievement differed between preclinical and clinical students. A survey was conducted among undergraduate medical students in Chiang Mai University, Thailand. The Index of Learning Styles questionnaire was used to assess each student's learning style across four domains. High academic achievement was defined as a grade point average of at least 3.0. Of the 1,248 eligible medical students, 1,014 (81.3%) participated. Learning styles differed between the preclinical and clinical students in the active/reflective domain. A sequential learning style was associated with high academic achievement in both preclinical and clinical students. A reflective learning style was only associated with high academic achievement among preclinical students. The association between learning styles and academic achievement may have differed between preclinical and clinical students due to different learning content and teaching methods. Students should be encouraged to be flexible in their own learning styles in order to engage successfully with various and changing teaching methods across the curriculum. Instructors should be also encouraged to provide a variety of teaching materials and resources to suit different learning styles.

A multi-institutional dosimetry audit of rotational intensity-modulated radiotherapy.

PubMed

Clark, Catharine H; Hussein, Mohammad; Tsang, Yatman; Thomas, Russell; Wilkinson, Dean; Bass, Graham; Snaith, Julia; Gouldstone, Clare; Bolton, Steve; Nutbrown, Rebecca; Venables, Karen; Nisbet, Andrew

2014-11-01

Rotational IMRT (VMAT and Tomotherapy) has now been implemented in many radiotherapy centres. An audit to verify treatment planning system modelling and treatment delivery has been undertaken to ensure accurate clinical implementation. 34 institutions with 43 treatment delivery systems took part in the audit. A virtual phantom planning exercise (3DTPS test) and a clinical trial planning exercise were planned and independently measured in each institution using a phantom and array combination. Point dose differences and global gamma index (γ) were calculated in regions corresponding to PTVs and OARs. Point dose differences gave a mean (±sd) of 0.1±2.6% and 0.2±2.0% for the 3DTPS test and clinical trial plans, respectively. 34/43 planning and delivery combinations achieved all measured planes with >95% pixels passing γ<1 at 3%/3mm and rose to 42/43 for clinical trial plans. A statistically significant difference in γ pass rates (p<0.01) was seen between planning systems where rotational IMRT modelling had been designed for the manufacturer's own treatment delivery system and those designed independently of rotational IMRT delivery. A dosimetry audit of rotational radiotherapy has shown that TPS modelling and delivery for rotational IMRT can achieve high accuracy of plan delivery. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Empirically supported treatments for panic disorder with agoraphobia in a Spanish psychology clinic.

PubMed

Ballesteros, Francisco; Labrador, Francisco J

2014-10-27

The aim of this work is to study the sociodemographic and clinical characteristics of patients diagnosed with Panic Disorder with Agoraphobia (PD/Ag), as well as the characteristics of the treatment and its results and cost in a University Psychology Clinic. Fifty patients demanded psychological assistance for PD/Ag; 80% were women, with an average age of 29.22 years (SD = 9.03). Mean number of evaluation sessions was 3.26 (SD = 1.03), and of treatment sessions, 13.39 (SD = 9.237). Of the patients, 83.33% were discharged (that is, questionnaire scores were below the cut-off point indicated by the authors, and no PD/Ag was observed at readministration of the semistructured interview), 5.5% refused treatment, and 11% were dropouts. The average number of treatment sessions of patients who achieved therapeutic success was 15.13 (SD = 8.98). Effect sizes (d) greater than 1 were obtained in all the scales. Changes in all scales were significant (p < .05). The estimated cost of treatment for patients who achieved therapeutic success was 945.12€. The treatment results are at least similar to those of studies of efficacy and effectiveness for PD/Ag. The utility of generalizing treatments developed in research settings to a welfare clinic is discussed.

[Achievements of an educational strategy promoting participation in the development of clinical aptitude and critical reading in cardiology residents, linked to appropriate use of research reports].

PubMed

Valencia-Sánchez, Jesús Salvador; Leyva-González, Félix Arturo; Viniegra-Velázquez, Leonardo

2007-01-01

To search the reach of educative strategy promoting the participation, to estimate the development of clinical aptitude and critical reading attaching the appropriate use of clinic research in cardiology residents. Prospective study. The instrument of clinical aptitude was constructed with five cases and 170 items and the instrument of critical reading was developed with five summaries of articles of clinical research in cardiology by 120 items. The strategy was performed with activities one a week during six months by two hours per class, in the period: March and September, 2005. Reading guides were delivered to the participants a week before that included a clinical case and clinic research of cardiology. During the activities in class we were promoting the participation and discussion. Both measuring instruments were performed in the first (initial measuring) and final session (final measuring). Non parametric test were used because the variable of the subjects were not normal distribution and the scale was ordinal. The reliability coefficient in both instruments with the Kuder-Richardson was 0.90 and 0.85 respectively. After educative strategy was observed a significant advance in the global calcifications, such as in critical reading and in clinical aptitude (p = 0.001 and 0.5 respectively). Analyzing in an independent manner the components of critical reading we found significant advancement in the indicators interpretation and judgment. In clinical aptitude we found significant progress in the indicators: the suitable use of paraclinics resources, the appropriate use of therapeutics measurement and iatropatogenic decisions for omission. The educative strategy promoting the participation, permitted to get a change in the clinical aptitude and critical reading attaching the appropriate use of sources of investigation in cardiology residents.

Comparative clinical outcomes between pediatric and young adult dialysis patients.

PubMed

Atkinson, Meredith A; Lestz, Rachel M; Fivush, Barbara A; Silverstein, Douglas M

2011-12-01

Published data on the comparative achievement of The Kidney Disease Dialysis Outcome Quality Initiative (KDOQI) recommended clinical performance targets between children and young adults on dialysis are scarce. To characterize the achievement of KDOQI targets among children (<18 years) and young adults (18-24 years) with prevalent end stage renal disease (ESRD), we performed a cross-sectional analysis of data collected by the Mid-Atlantic Renal Coalition, in conjunction with the 2007 and 2008 ESRD Clinical Performance Measures Projects. Data on all enrolled pediatric dialysis patients, categorized into three age groups (0-8, 9-12, 13-17 years), and on a random sample of 5% of patients ≥ 18 years in ESRD Network 5 were examined for two study periods: hemodialysis (HD) data were collected from October to December 2006 and from October to December 2007 and peritoneal dialysis (PD) data were collected from October 2006 to March 2007 and from October 2007 to March 2008. In total, 114 unique patients were enrolled the study, of whom 41.2% (47/114) were on HD and 58.8% (67/114) on PD. Compared to the pediatric patients, young adults were less likely to achieve the KDOQI recommended serum phosphorus levels and serum calcium × phosphorus product values, with less than one-quarter demonstrating values at or below each goal. Multivariate analysis revealed that both young adults and 13- to 17-year-olds were less likely to achieve target values for phosphorus [young adults: odds ratio (OR) 0.04, 95% confidence interval (95% CI) 0.01-0.19, p < 0.001; 13- to 17-year-olds: OR 0.17, 95% CI 0.04-0.77, p = 0.02] and calcium × phosphorus product (young adults: OR 0.01, 95% CI 0.002-0.09, p < 0.001; 13- to 17-year-olds: OR 0.09, 95% CI 0.02-0.56, p = 0.01) than younger children. In summary, there are significant differences in clinical indices between pediatric and young adult ESRD patients.

Optimization of oncological {sup 18}F-FDG PET/CT imaging based on a multiparameter analysis

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

Menezes, Vinicius O., E-mail: vinicius@radtec.com.br; Machado, Marcos A. D.; Queiroz, Cleiton C.

2016-02-15

Purpose: This paper describes a method to achieve consistent clinical image quality in {sup 18}F-FDG scans accounting for patient habitus, dose regimen, image acquisition, and processing techniques. Methods: Oncological PET/CT scan data for 58 subjects were evaluated retrospectively to derive analytical curves that predict image quality. Patient noise equivalent count rate and coefficient of variation (CV) were used as metrics in their analysis. Optimized acquisition protocols were identified and prospectively applied to 179 subjects. Results: The adoption of different schemes for three body mass ranges (<60 kg, 60–90 kg, >90 kg) allows improved image quality with both point spread functionmore » and ordered-subsets expectation maximization-3D reconstruction methods. The application of this methodology showed that CV improved significantly (p < 0.0001) in clinical practice. Conclusions: Consistent oncological PET/CT image quality on a high-performance scanner was achieved from an analysis of the relations existing between dose regimen, patient habitus, acquisition, and processing techniques. The proposed methodology may be used by PET/CT centers to develop protocols to standardize PET/CT imaging procedures and achieve better patient management and cost-effective operations.« less

What variables can influence clinical reasoning?

PubMed

Ashoorion, Vahid; Liaghatdar, Mohammad Javad; Adibi, Peyman

2012-12-01

Clinical reasoning is one of the most important competencies that a physician should achieve. Many medical schools and licensing bodies try to predict it based on some general measures such as critical thinking, personality, and emotional intelligence. This study aimed at providing a model to design the relationship between the constructs. Sixty-nine medical students participated in this study. A battery test devised that consist four parts: Clinical reasoning measures, personality NEO inventory, Bar-On EQ inventory, and California critical thinking questionnaire. All participants completed the tests. Correlation and multiple regression analysis consumed for data analysis. There is low to moderate correlations between clinical reasoning and other variables. Emotional intelligence is the only variable that contributes clinical reasoning construct (r=0.17-0.34) (R(2) chnage = 0.46, P Value = 0.000). Although, clinical reasoning can be considered as a kind of thinking, no significant correlation detected between it and other constructs. Emotional intelligence (and its subscales) is the only variable that can be used for clinical reasoning prediction.

Factors Associated with Veterinary Clinical Faculty Attrition.

PubMed

Furr, Martin

Faculty attrition and recruitment for veterinary clinical faculty positions have been reported as significant problems in veterinary medical education. To investigate the factors that may be important in veterinary clinical faculty retention, the perceptions and views of veterinary clinical academic faculty were determined using a web-distributed electronic survey. Responses were dichotomized by whether the respondent had or had not left an academic position and were analyzed for their association with faculty attrition. A total of 1,226 responses were recorded, and results demonstrated that factors other than compensation were associated with veterinary clinical faculty attrition, including departmental culture, work-life balance, and recognition and support of clinical medicine by the administration. Forty-four percent of respondents who had held a faculty appointment reported leaving academia either voluntarily or for non-voluntary reasons such as failure to achieve tenure, retirement, or having their position closed. Attention to correcting deficiencies in workplace culture and professional rewards could be a beneficial means by which to decrease the faculty attrition rates currently observed in clinical academic veterinary medicine.

Clinical Decisions Made in Primary Care Clinics Before and After Choosing Wisely.

PubMed

Kost, Amanda; Genao, Inginia; Lee, Jay W; Smith, Stephen R

2015-01-01

The Choosing Wisely campaign encourages physicians to avoid low-value care. Although widely lauded, no study has examined its impact on clinical decisions made in primary care settings. We compared clinical decisions made for 5 Choosing Wisely recommendations over two 6-month time periods before and after the campaign launch and an educational intervention to promote it at 3 primary care residency clinics. The rate of recommendations adherence was high (93.2%) at baseline but did significantly increase to 96.5% after the launch. These findings suggest primary care physicians respond to training and publicity in low-value care, though further research is needed. Given that even small decreases of physician test ordering can produce large cost savings, the Choosing Wisely project may help achieve the health care triple aim. © Copyright 2015 by the American Board of Family Medicine.

Diabetic Retinopathy: Pathophysiology and Treatments.

PubMed

Wang, Wei; Lo, Amy C Y

2018-06-20

Diabetic retinopathy (DR) is the most common complication of diabetes mellitus (DM). It has long been recognized as a microvascular disease. The diagnosis of DR relies on the detection of microvascular lesions. The treatment of DR remains challenging. The advent of anti-vascular endothelial growth factor (VEGF) therapy demonstrated remarkable clinical benefits in DR patients; however, the majority of patients failed to achieve clinically-significant visual improvement. Therefore, there is an urgent need for the development of new treatments. Laboratory and clinical evidence showed that in addition to microvascular changes, inflammation and retinal neurodegeneration may contribute to diabetic retinal damage in the early stages of DR. Further investigation of the underlying molecular mechanisms may provide targets for the development of new early interventions. Here, we present a review of the current understanding and new insights into pathophysiology in DR, as well as clinical treatments for DR patients. Recent laboratory findings and related clinical trials are also reviewed.

Update on dialysis economics in the UK.

PubMed

Sharif, Adnan; Baboolal, Keshwar

2011-03-01

The burgeoning population of patients requiring renal replacement therapy contributes a disproportionate strain on National Health Service resources. Although renal transplantation is the preferred treatment modality for patients with established renal failure, achieving both clinical and financial advantages, limitations to organ donation and clinical comorbidities will leave a significant proportion of patients with established renal failure requiring expensive dialysis therapy in the form of either hemodialysis or peritoneal dialysis. An understanding of dialysis economics is essential for both healthcare providers and clinical leaders to establish clinically efficient and cost-effective treatment modalities that maximize service provision. In light of changes to the provision of healthcare funds in the form of "Payment by Results," it is imperative for UK renal units to adopt clinically effective and financially accountable dialysis programs. This article explores the role of dialysis economics and implications for UK renal replacement therapy programs.

Development and Validation of a Novel Vancomycin Dosing Nomogram for Achieving High-Target Trough Levels at 2 Canadian Teaching Hospitals

PubMed Central

Thalakada, Rosanne; Legal, Michael; Lau, Tim T Y; Luey, Tiffany; Batterink, Josh; Ensom, Mary H H

2012-01-01

Background: Recent guidelines recommend a vancomycin trough (predose) level between 15 and 20 mg/L in the treatment of invasive gram-positive infections, but most initial dosing nomograms are designed to achieve lower targets (5–15 mg/L). Clinicians need guidance about appropriate initial dosing to achieve the higher target. Objective: To develop and validate a high-target vancomycin dosing nomogram to achieve trough levels of 15–20 mg/L. Methods: A retrospective study was conducted at 2 teaching hospitals, St Paul’s Hospital and Vancouver General Hospital in Vancouver, British Columbia. Patients who were treated with vancomycin between January 2008 and June 2010 and who had achieved a trough level of 14.5–20.5 mg/L were identified. Demographic and clinical data were collected. Multiple linear regression was used to develop a vancomycin dosing nomogram for each hospital site. An integrated nomogram was constructed by merging the data from the 2 hospitals. A unique set of patients at each institution was used for validating their respective nomograms and a pooled group of patients for validating the integrated nomogram. Predictive success was evaluated, and a nomogram was deemed significantly different from another nomogram if p < 0.05 via “χ2 testing. Results: Data from 78 patients at one hospital and 91 patients at the other were used in developing the respective institutional nomograms. For each hospital’s data set, both age and initial serum creatinine were significantly associated with the predicted dosing interval (p < 0.001). Validation in a total of 105 test patients showed that the integrated nomogram had a predictive success rate of 56%. Conclusions: A novel vancomycin dosing nomogram was developed and validated at 2 Canadian teaching hospitals. This integrated nomogram is a tool that clinicians can use in selecting appropriate initial vancomycin regimens on the basis of age and serum creatinine, to achieve high-target levels of 15–20 mg/L. The nomogram should not replace clinical judgment for patients with unstable and/or reduced renal function. PMID:22783028

Non-HDL Cholesterol and Triglycerides: Implications for Coronary Atheroma Progression and Clinical Events.

PubMed

Puri, Rishi; Nissen, Steven E; Shao, Mingyuan; Elshazly, Mohamed B; Kataoka, Yu; Kapadia, Samir R; Tuzcu, E Murat; Nicholls, Stephen J

2016-11-01

Non-high-density lipoprotein cholesterol (non-HDLC) levels reflect the full burden of cholesterol transported in atherogenic lipoproteins. Genetic studies suggest a causal association between elevated triglycerides (TGs)-rich lipoproteins and atherosclerosis. We evaluated associations between achieved non-HDLC and TG levels on changes in coronary atheroma volume. Data were analyzed from 9 clinical trials involving 4957 patients with coronary disease undergoing serial intravascular ultrasonography to assess changes in percent atheroma volume (ΔPAV) and were evaluated against on-treatment non-HDLC and TG levels. The effects of lower (<100 mg/dL) versus higher (≥100 mg/dL) achieved non-HDLC levels and lower (<200 mg/dL) versus higher (≥200 mg/dL) achieved TG levels were evaluated in populations with variable on-treatment low-density lipoprotein cholesterol (LDLC) 0) was associated with achieved TG levels >200 mg/dL, respectively. Lower on-treatment non-HDLC and TG levels associated with significant PAV regression compared with higher non-HDLC and TG levels across all levels of LDLC and C-reactive protein and irrespective of diabetic status (P<0.001 across all comparisons). ΔPAV were more strongly influenced by changes in non-HDLC (β=0.62; P<0.001) compared with changes in LDLC (β=0.51; P<0.001). Kaplan-Meier sensitivity analyses demonstrated significantly greater major adverse cardiovascular event rates in those with higher versus lower non-HDLC and TG levels, with an earlier separation of the non-HDLC compared with the LDLC curve. Achieved non-HDLC levels seem more closely associated with coronary atheroma progression than LDLC. Plaque progression associates with achieved TGs, but only above levels of 200 mg/dL. These observations support a more prominent role for non-HDLC (and possibly TG) lowering in combating residual cardiovascular risk. © 2016 American Heart Association, Inc.

Vibration arthrometry: a critical review.

PubMed

Abbott, Steven C; Cole, Michael D

2013-01-01

The clinical value of sounds and vibrations produced by biological joints in motion has been studied extensively since 1902, aimed at developing a technology to aid the interpretation of recorded joint vibration signals. Such technology would have clear advantages to current medical imaging systems, e.g. MRI, in speed, cost, and non-invasiveness. However, it has yet to achieve routine clinical use. This review aims to provide a balanced analysis of past and present attempts to progress vibration arthrometry. The literature reveals significant barriers to successful implementation of vibration arthrometry. From a technical standpoint, accounting for the intense variability within recorded signals caused by shifting characteristics of contacting joint surfaces and forces during motion is the primary issue. Additionally, understandable scepticism in the clinical community as to the reliability of vibration arthrometry represents a significant barrier to adoption. In conclusion, until the variability issue is shown to be adequately dealt with, and clear transparent evidence of clinical usefulness to orthopedic medicine demonstrated, it will be difficult to move the field forward. Future work should lead toward proving value to clinicians, and be transparent about how the variability issue has been resolved.

[Effectiveness of cognitive-behavioral therapy in children and adolescents with obsessive-compulsive disorders treated in an outpatient clinic].

PubMed

Beig, Inga; Döpfner, Manfred; Goletz, Hildegard; Plück, Julia; Dachs, Lydia; Kinnen, Claudia; Walter, Daniel

2017-01-01

Cognitive-behavioral therapy (CBT) is considered as treatment of first choice for children and adolescents with obsessive-compulsive disorders (OCD). However, its effectiveness has so far mostly been examined in randomized controlled trials with strictly manualized interventions. Only few studies have examined whether the effectiveness of CBT for juvenile OCD generalizes to clinical practice. To test the effectiveness of CBT under routine care conditions, data of n = 53 patients with parent-ratings and n = 53 patients with self-ratings that were treated in a university-based outpatient clinic for child and adolescent psychotherapy was analyzed. Pre-post-mean-comparisons, effect sizes and the clinical significance of changes of the symptoms were examined. OCD and comorbid symptoms were significantly reduced during treatment. Strong effect sizes (Cohen’s d) were found for parent rated (d = 0.91) and patient rated (d = 0.88) OCD symptoms. Moderate to strong pre-post-effect sizes were found for the reduction of parent rated (d = 0.55 to d = 0.87) and patient rated (d = 0.46 to d = 0.74) comorbid symptoms. The percentage of children and adolescents who achieved clinically significant improvements and no longer showed dysfunctional OCD symptoms post-treatment was 46.3 % according to the parent-ratings and 59.4 % according to the self-ratings. Concerning comorbid symptoms the same was reached for between 22.5 % and 45.5 % of the patients (parent-ratings) and between 32.0 % and 81.8 % (self-ratings) respectively. Significant reductions in both OCD and comorbid symptoms were demonstrated over the course of cognitive-behavioral therapy of juvenile OCD disorders in a university outpatient clinic for child and adolescent psychotherapy. These results indicate that routine CBT treatment is an effective way to treat juvenile OCD disorders in clinical practice.

3D accuracy of implant positions in template-guided implant placement as a function of the remaining teeth and the surgical procedure: a retrospective study.

PubMed

Schnutenhaus, Sigmar; Edelmann, Cornelia; Rudolph, Heike; Dreyhaupt, Jens; Luthardt, Ralph G

2018-01-22

The aim of this study was to investigate differences between the virtually planned and clinically achieved implant positions in completely template-guided implantations as a function of the type of edentulous space, the residual natural dentition, and the surgical implementation. Fifty-six patient cases with a total of 122 implants were evaluated retrospectively. The implantations were completely template-based. The data of the planned implant positions were overlaid with the actual clinical implant positions, followed by measurements of the 3D deviations in terms of coronal (x c ) and apical distance, height (x h ), and angulation (ang) and statistical analysis. The mean x c was 1.2 mm (SD 0.7 mm); the mean x a was 1.8 mm (SD 0.9 mm), the mean x h was 0.8 mm (SD 0.7 mm); and the mean ang was 4.8° (SD 3.1). The type of edentulous space and the jaw (maxilla/mandible) had no significant effect on the results in terms of implant positions. The presence of an adjacent natural tooth at the time of implantation had a significant influence on x h (p = 0.04) and ang (p = 0.05). No significant differences were found regarding the surgical approach for any of the parameters examined. The results of our study are in the same range as those of other studies. Template-guided implantation offers a high degree of accuracy even in the presence of different configurations of the residual dentition or different surgical approaches. A clinical benefit is therefore present, especially from a prosthetic point of view. The clinically achievable accuracy can be described as sufficient for further prosthetic treatment, given the intrinsic and methodological tolerances, making prosthetic rehabilitation safe and predictable.

[Impact of cryopreservation duration of 605 units umbilical cord blood on quality of hematopoietic stem cell and outcome of clinical transplantation].

PubMed

Zhang, Yi; Zhu, Hua; Jin, Huanying; Wang, Yinting; Shao, Xiayan; Kong, Jingsi; Huang, Wenhao; Hong, Yan; Li, Chunli; Gao, Feng; Chen, Liang; Wang, Feng; Lu, Yao

2015-01-01

To investigate the impact of cryopreservation duration of umbilical cord blood (UCB) on quality of hematopoietic stem cell and outcome of clinical transplantation. 605 units of UCB which had been used in clinical transplantation were previously cryopreserved for 820 (88-2651) days in average. UCB was detected for total nucleated cell count, CD34+ cells count, cell recovery rate, cell viability and CFU-GM after thawing. No statistical correlation was found between cryopreservation duration and cell recovery rate, cell viability. CFU-GM decreased along with the extension of cryopreservation duration (P=0.011), ranging between 109.6 and 105.7/1 × 10⁵. There was no significant difference on hematopoietic reconstitution time, graft failure, acute GVHD and overall survival among groups with different cryopreservation duration. Cryopreservation duration has no significant effect on cell recovery rate, cell viability and clinical transplantation outcome. Extension of cryopreservation duration may reduce CFU-GM of stem cells with fluctaion still in normal range. UCB could maintain cell viability and function to achieve satisfactory clinical transplantation outcome even when thawed after 3 to 7 years' cryopreservation.

Substance use, substance abuse, and LD among adolescents with a childhood history of ADHD.

PubMed

Molina, B S; Pelham, W E

2001-01-01

A clinic-referred sample of 109 children with attention-deficit/hyperactivity disorder (ADHD) was followed into adolescence for the ascertainment of alcohol and other drug use and abuse. Learning disability (reading or math) in childhood was examined as a predictor of adolescent substance use and substance use disorder for alcohol and marijuana. No statistically significant group differences for children with LD versus those without LD emerged even after using different methods to compute LD. IQ/achievement discrepancy scores were similarly not predictive of later use or abuse. However, children with ADHD who had higher IQs and higher levels of academic achievement in childhood were more likely to try cigarettes, to smoke daily, and to have their first drink of alcohol or first cigarette at an early age. Children with ADHD who had higher reading achievement scores were less likely to have later alcohol use disorder. Although these findings are necessarily preliminary, due to the small number of children interviewed, the pattern of results suggests that level of cognitive functioning--rather than discrepancy between IQ and achievement--is important for the prediction of later substance use and abuse, at least in this clinic-referred sample of children with ADHD. Further, different mechanisms of risk related to cognitive functioning may be operating for experimentation with legal drugs such as alcohol and tobacco, regular cigarette smoking, and problematic alcohol use.

Can anti-Mullerian hormone (AMH) predict the outcome of intrauterine insemination with controlled ovarian stimulation?

PubMed

Bakas, Panagiotis; Boutas, Ioannis; Creatsa, Maria; Vlahos, Nicos; Gregoriou, Odysseas; Creatsas, George; Hassiakos, Dimitrios

2015-10-01

To assess whether the levels of anti-Mullerian hormone (AMH) are related to outcome of intrauterine insemination (IUI) in patients treated with gonadotropins. A total of 195 patients underwent controlled ovarian stimulation (COS) with recombinant follicle stimulating hormone (rFSH) (50-150 IU/d). All patients were submitted upto three cycles of IUI. Primary outcome was the ability of AMH levels to predict clinical pregnancy at first attempt and the cumulative clinical pregnancy probability of upto three IUI cycles. Secondary outcomes were the relation of AMH, LH, FSH, BMI, age, parity and basic estradiol levels with each other and the outcome of IUI. The area under the receiver operating characteristic (ROC) curve in predicting clinical pregnancy for AMH at first attempt was 0.53 and for cumulative clinical pregnancy was 0.76. AMH levels were positively correlated with clinical pregnancy rate at first attempt and with cumulative clinical pregnancy rate, but negatively correlated with patient's age and FSH levels. Patient's FSH, LH levels were negatively correlated with cumulative clinical pregnancy rate. AMH levels seem to have a positive correlation and patient's age and LH levels had a negative correlation with the outcome of IUI and COS with gonadotropins. AMH concentration was significantly higher and LH was significantly lower in patients with a clinical pregnancy after three cycles of IUI treatment compared with those who did not achieve pregnancy.

The technologies of time measurement: implications at the bedside and the bench.

PubMed

Reiser, S J

2000-01-04

This essay explores how chronologically linked indices of health and illness, such as variation in body temperature, achieved clinical and scientific significance. It shows why time has been a potent concept through which key associations among the data of medicine are ordered and revealed, and it examines the graphical and case reporting methods of organizing evidence that made such associations possible.

Evaluation of a pilot hypertension management programme for Guatemalan adults.

PubMed

Mendoza Montano, Carlos; Fort, Meredith; deRamirez, Miriam; Cruz, Judith; Ramirez-Zea, Manuel

2016-06-01

Corazón Sano y Feliz is a hypertension management intervention developed to address deficiencies in the management of hypertensive patients in Guatemala. From 2007 to 2009, Corazón Sano y Feliz was pilot-tested in the community of Mixco. Corazón Sano y Feliz comprises a clinical risk assessment and treatment component implemented primarily by nurses, and a health education component implemented by community health workers. To accomplish our secondary objective of determining Corazon Sano y Feliz's potential for change at the patient level, we implemented a one-group pretest-posttest study design to examine changes in clinical measures, knowledge and practices between baseline and the end of the 6-month intervention. Two nurses and one physician set up a hypertension clinic to manage patients according to risk level. Twenty-nine community health workers were trained in CVD risk reduction and health promotion and in turn led six educational sessions for patients. Comparing baseline and 6-month measures, the intervention achieved significant improvements in mean knowledge and behaviour (increase from 54.6 to 59.1 out of a possible 70 points) and significant reductions of mean systolic and diastolic blood pressure (27.2 and 7.7 mmHg), body mass index (from 26.5 to 26.2 kg/m(2)) and waist circumference (89.6-88.9 cm). In this pilot study we obtained preliminary evidence that this community-oriented hypertension management and health promotion intervention model was feasible and achieved significant reduction in risk factors. If scaled up, this intervention has the potential to substantially reduce CVD burden. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Trauma-focused exposure therapy for chronic posttraumatic stress disorder in alcohol and drug dependent patients: A randomized controlled trial.

PubMed

Coffey, Scott F; Schumacher, Julie A; Nosen, Elizabeth; Littlefield, Andrew K; Henslee, Amber M; Lappen, Amy; Stasiewicz, Paul R

2016-11-01

To test whether a modified version of prolonged exposure (mPE) can effectively treat posttraumatic stress disorder (PTSD) in individuals with co-occurring PTSD and substance dependence, an efficacy trial was conducted in which substance dependent treatment-seekers with PTSD (N = 126, male = 54.0%, White = 79.4%) were randomly assigned to mPE, mPE + trauma-focused motivational enhancement session (mPE + MET-PTSD), or a health information-based control condition (HLS). All participants were multiply traumatized; the median number of reported traumas that satisfied DSM-IV Criterion A for PTSD was 8. Treatment consisted of 9-12 60-min individual therapy sessions plus substance abuse treatment-as-usual. Participants were assessed at baseline, end-of-treatment, and at 3- and 6-months posttreatment. Both the mPE and mPE + MET-PTSD conditions achieved significantly better PTSD outcome than the control condition. The mPE + MET-PTSD and mPE conditions did not differ from one another on PTSD symptoms at end of treatment, 3-, or 6-month follow-up. Substance use outcomes did not differ between groups with all groups achieving 85.7%-97.9% days abstinent at follow-up. In regard to clinically significant improvement in trauma symptoms, 75.8% of the mPE participants, 60.0% of the mPE + MET-PTSD participants, and 44.4% of the HLS participants experienced clinically significant improvement at the end-of-treatment. Results indicate mPE, with or without an MET-PTSD session, can effectively treat PTSD in patients with co-occurring PTSD and substance dependence. In addition, mPE session lengths may better suit standard clinical practice and are associated with medium effect sizes. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Pragmatic replication trial of health promotion coaching for obesity in serious mental illness and maintenance of outcomes.

PubMed

Bartels, Stephen J; Pratt, Sarah I; Aschbrenner, Kelly A; Barre, Laura K; Naslund, John A; Wolfe, Rosemarie; Xie, Haiyi; McHugo, Gregory J; Jimenez, Daniel E; Jue, Ken; Feldman, James; Bird, Bruce L

2015-04-01

Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population. Persons with serious mental illness and a body mass index (BMI) >25 receiving services in three community mental health organizations were recruited and randomly assigned either to the 12-month In SHAPE program, which included membership in a public fitness club and weekly meetings with a health promotion coach, or to fitness club membership alone. The primary outcome measures were weight and cardiorespiratory fitness (as measured with the 6-minute walk test), assessed at baseline and at 3, 6, 9, 12, and 18 months. Participants (N=210) were ethnically diverse (46% were nonwhite), with a mean baseline BMI of 36.8 (SD=8.2). At 12 months, the In SHAPE group (N=104) had greater reduction in weight and improved fitness compared with the fitness club membership only group (N=106). Primary outcomes were maintained at 18 months. Approximately half of the In SHAPE group (51% at 12 months and 46% at 18 months) achieved clinically significant cardiovascular risk reduction (a weight loss ≥5% or an increase of >50 meters on the 6-minute walk test). This is the first replication study confirming the effectiveness of a health coaching intervention in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness.

Rapid response predicts 12-month post-treatment outcomes in binge-eating disorder: theoretical and clinical implications

PubMed Central

Grilo, C. M.; White, M. A.; Wilson, G. T.; Gueorguieva, R.; Masheb, R. M.

2011-01-01

Background We examined rapid response in obese patients with binge-eating disorder (BED) in a clinical trial testing cognitive behavioral therapy (CBT) and behavioral weight loss (BWL). Method Altogether, 90 participants were randomly assigned to CBT or BWL. Assessments were performed at baseline, throughout and post-treatment and at 6- and 12-month follow-ups. Rapid response, defined as ≥70% reduction in binge eating by week four, was determined by receiver operating characteristic curves and used to predict outcomes. Results Rapid response characterized 57% of participants (67% of CBT, 47% of BWL) and was unrelated to most baseline variables. Rapid response predicted greater improvements across outcomes but had different prognostic significance and distinct time courses for CBT versus BWL. Patients receiving CBT did comparably well regardless of rapid response in terms of reduced binge eating and eating disorder psychopathology but did not achieve weight loss. Among patients receiving BWL, those without rapid response failed to improve further. However, those with rapid response were significantly more likely to achieve binge-eating remission (62% v. 13%) and greater reductions in binge-eating frequency, eating disorder psychopathology and weight loss. Conclusions Rapid response to treatment in BED has prognostic significance through 12-month follow-up, provides evidence for treatment specificity and has clinical implications for stepped-care treatment models for BED. Rapid responders who receive BWL benefit in terms of both binge eating and short-term weight loss. Collectively, these findings suggest that BWL might be a candidate for initial intervention in stepped-care models with an evaluation of progress after 1 month to identify non-rapid responders who could be advised to consider a switch to a specialized treatment. PMID:21923964

[Exclusive enteral nutrition continues to be first line therapy for pediatric Crohn's disease in the era of biologics].

PubMed

Navas-López, V M; Blasco-Alonso, J; Lacasa Maseri, S; Girón Fernández-Crehuet, F; Serrano Nieto, M J; Vicioso Recio, M I; Sierra Salinas, C

2015-07-01

Exclusive enteral nutrition (EEN) has been to be more effective than corticosteroids in achieving mucosal healing without their side effects. To determine the efficacy of EEN in terms of inducing clinical remission in newly diagnosed CD children and to study the efficacy of this therapeutic approach in improving the degree of intestinal mucosa inflammation. The medical records of patients with newly diagnosed Crohn's disease treated with EEN were reviewed retrospectively. The degree of mucosal inflammation was assessed by fecal calprotectin (FC). Remission was defined as a PCDAI<10. Forty patients (24 males) were included, the age at diagnosis was 11.6 ± 3.6 years. Of the 34 patients who completed the EEN period, 32 (94% per-protocol analysis) achieved clinical remission. This percentage fell to 80% in the intention-to-treat analysis. The compliance rate was 95%. Duration of EEN was 6.42 weeks (IQR 6.0-8.14). FC was significantly higher in patients with moderate and severe disease. Median baseline FC levels (680 μg/g) decreased significantly to 218 μg/g (P<0.0001) after EEN. We found a statistically significant correlation between FC and PCDAI (rho=0.727; P<0.0001). Early use of thiopurines (< 8 weeks) versus subsequent use was not associated with improved outcomes during the follow-up. EEN administered for 6-8 weeks is effective for inducing clinical remission and decreasing the degree of mucosal inflammation. We did not find differences in terms of maintenance of remission in patients treated early with thiopurines. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

Collaborative Chronic Care Models for Mental Health Conditions: Cumulative Meta-Analysis and Meta-Regression to Guide Future Research and Implementation

PubMed Central

Grogan-Kaylor, Andrew; Perron, Brian E.; Kilbourne, Amy M.; Woltmann, Emily; Bauer, Mark S.

2013-01-01

Objective Prior meta-analysis indicates that collaborative chronic care models (CCMs) improve mental and physical health outcomes for individuals with mental disorders. This study aimed to investigate the stability of evidence over time and identify patient and intervention factors associated with CCM effects in order to facilitate implementation and sustainability of CCMs in clinical practice. Method We reviewed 53 CCM trials that analyzed depression, mental quality of life (QOL), or physical QOL outcomes. Cumulative meta-analysis and meta-regression were supplemented by descriptive investigations across and within trials. Results Most trials targeted depression in the primary care setting, and cumulative meta-analysis indicated that effect sizes favoring CCM quickly achieved significance for depression outcomes, and more recently achieved significance for mental and physical QOL. Four of six CCM elements (patient self-management support, clinical information systems, system redesign, and provider decision support) were common among reviewed trials, while two elements (healthcare organization support and linkages to community resources) were rare. No single CCM element was statistically associated with the success of the model. Similarly, meta-regression did not identify specific factors associated with CCM effectiveness. Nonetheless, results within individual trials suggest that increased illness severity predicts CCM outcomes. Conclusions Significant CCM trials have been derived primarily from four original CCM elements. Nonetheless, implementing and sustaining this established model will require healthcare organization support. While CCMs have typically been tested as population-based interventions, evidence supports stepped care application to more severely ill individuals. Future priorities include developing implementation strategies to support adoption and sustainability of the model in clinical settings while maximizing fit of this multi-component framework to local contextual factors. PMID:23938600

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.

Effect of thyroxine therapy on autonomic status in hypothyroid patients.

PubMed

Lakshmi, Vijaya; Vaney, N; Madhu, S V

2009-01-01

The aim of the present study was to evaluate the impact of hypothyroidism on the autonomic regulation of the cardiovascular system by analyzing sympathetic and parasympathetic influences on the heart and the effect of thyroxine replacement. Thirty newly diagnosed female hypothyroid patients with mean age 32.73 +/- 9.98 years were recruited from the Thyroid Clinic, GTB Hospital, Delhi. Various Autonomic function tests to assess Basal heart rate variability, parasympathetic activity (E:I Ratio, 30:15 Ratio, Valsalva Ratio) and sympathetic activity (Postural Challenge test, Sustained handgrip test) were done before and after attainment of euthyroidism. There was significant increase in parasympathetic activity on achieving euthyroid state. The sympathetic activity too significantly improved after L-thyroxine supplementation. Lipid profile parameters significantly decreased after achieving euthyroid state. Our findings are consistent with previous reports that thyroxine therapy appears to restore the efferent vagal activity and alters the relative contribution of systems that maintain resting blood pressure and heart rate.

Comparing community and specialty provider-based recruitment in a randomized clinical trial: clinical trial in fecal incontinence.

PubMed

Whitebird, Robin R; Bliss, Donna Zimmaro; Savik, Kay; Lowry, Ann; Jung, Hans-Joachim G

2010-12-01

Recruitment of participants to clinical trials remains a significant challenge, especially for research addressing topics of a sensitive nature such as fecal incontinence (FI). In the Fiber Study, a randomized controlled trial on symptom management for FI, we successfully enrolled 189 community-living adults through collaborations with specialty-based and community-based settings, each employing methods tailored to the organizational characteristics of their site. Results show that using the two settings increased racial and ethnic diversity of the sample and inclusion of informal caregivers. There were no differential effects on enrollment, final eligibility, or completion of protocol by site. Strategic collaborations with complementary sites can achieve sample recruitment goals for clinical trials on topics that are sensitive or known to be underreported. Copyright © 2010 Wiley Periodicals, Inc.

Treatment of transverse patellar fractures: a comparison between metallic and non-metallic implants.

PubMed

Heusinkveld, Maarten H G; den Hamer, Anniek; Traa, Willeke A; Oomen, Pim J A; Maffulli, Nicola

2013-01-01

Several methods of transverse patellar fixation have been described. This study compares the clinical outcome and the occurrence of complications of various fixation methods. The databases PubMed, Web of Science, Science Direct, Google Scholar and Google were searched. A direct comparison between fixation techniques using mixed or non-metallic implants and metallic K-wire and tension band fixation shows no significant difference in clinical outcome between both groups. Additionally, studies reporting novel operation techniques show good clinical results. Studies describing the treatment of patients using non-metallic or mixed implants are fewer compared with those using metallic fixation. A large variety of clinical scoring systems were used for assessing the results of treatment, which makes direct comparison difficult. More data of fracture treatment using non-metallic or mixed implants is needed to achieve a more balanced comparison.

Does bipolar electrocoagulation time affect vessel weld strength?

PubMed Central

Harrison, J D; Morris, D L

1991-01-01

The value of the bipolar electrocoagulator in the haemostasis of bleeding ulcers is controversial. We have therefore investigated the effect of different coagulation times on vessel weld strength achieved by the bipolar device. Welds were then made in vessels of known diameter using a standard 10F endoscopic haemostatic probe at coagulation times of two and 20 seconds. The intravascular temperature achieved at each time was measured. Vessel weld strength achieved by bipolar electrocoagulation was much greater at 20 seconds (approximately twice that at two seconds) and was highly significantly greater at all vessel diameters. There was a gradual reduction in weld strength with increasing vessel diameter, an effect that was seen for both two and 20 seconds of electrocoagulation. Intravascular temperature was significantly higher at 20 seconds than at two seconds. We conclude that vessel weld strength is related to coagulation time and that any future studies comparing the bipolar electrocoagulator with other haemostatic devices should use longer periods of bipolar electrocoagulation and record the coagulation time in order to optimise the clinical value of the device. PMID:1864540

"This clinic is number one": a qualitative study of factors that contribute toward "successful" care at a South African Pediatric HIV/AIDS clinic.

PubMed

Watermeyer, Jennifer

2012-09-01

HIV/AIDS has significantly affected health care practices. The need for high adherence and regular clinic visits places pressure on health care providers and patients. Poor quality of care has been described in many contexts, but some clinics have achieved excellent treatment results. Using a success case approach, this study aimed to understand factors which contribute to successful care at a South African pediatric HIV/AIDS clinic with documented high patient adherence and follow-up rates. Data included over 50 hours of ethnographic observations and interviews with a total of 35 clinic staff and caregivers. Thematic analysis highlighted strong congruence between caregiver and staff perceptions. Factors which seemed to contribute to successful care included organizational routines, staff-patient relationships, communication, teamwork, leadership, job commitment, caregivers' negative experiences at other clinics, and faith in the "life-saving" care at this clinic. Results suggest the need for all factors to be present in order to promote quality of care. Recommendations for other clinic settings are discussed.

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.

Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis.

PubMed

Wallace, Carol A; Giannini, Edward H; Spalding, Steven J; Hashkes, Philip J; O'Neil, Kathleen M; Zeft, Andrew S; Szer, Ilona S; Ringold, Sarah; Brunner, Hermine I; Schanberg, Laura E; Sundel, Robert P; Milojevic, Diana; Punaro, Marilynn G; Chira, Peter; Gottlieb, Beth S; Higgins, Gloria C; Ilowite, Norman T; Kimura, Yukiko; Hamilton, Stephanie; Johnson, Anne; Huang, Bin; Lovell, Daniel J

2012-06-01

To determine whether aggressive treatment initiated early in the course of rheumatoid factor (RF)-positive or RF-negative polyarticular juvenile idiopathic arthritis (JIA) can induce clinical inactive disease within 6 months. Between May 2007 and October 2010, a multicenter, prospective, randomized, double-blind, placebo-controlled trial of 2 aggressive treatments was conducted in 85 children ages 2-16 years with polyarticular JIA of <12 months' duration. Patients received either methotrexate (MTX) 0.5 mg/kg/week (maximum 40 mg) subcutaneously, etanercept 0.8 mg/kg/week (maximum 50 mg), and prednisolone 0.5 mg/kg/day (maximum 60 mg) tapered to 0 by 17 weeks (arm 1), or MTX (same dosage as arm 1), etanercept placebo, and prednisolone placebo (arm 2). The primary outcome measure was clinical inactive disease at 6 months. An exploratory phase determined the rate of clinical remission on medication (6 months of continuous clinical inactive disease) at 12 months. By 6 months, clinical inactive disease had been achieved in 17 (40%) of 42 patients in arm 1 and 10 (23%) of 43 patients in arm 2 (χ(2) = 2.91, P = 0.088). After 12 months, clinical remission on medication was achieved in 9 patients in arm 1 and 3 patients in arm 2 (P = 0.053). There were no significant interarm differences in adverse events. Although this study did not meet its primary end point, early aggressive therapy in this cohort of children with recent-onset polyarticular JIA resulted in clinical inactive disease by 6 months and clinical remission on medication within 12 months of treatment in substantial proportions of patients in both arms. Copyright © 2012 by the American College of Rheumatology.

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

PubMed

Obreli-Neto, Paulo Roque; Marusic, Srecko; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Renovato, Rogério Dias; Pilger, Diogo; Cuman, Roberto Kenji Nakamura; Pereira, Leonardo Régis Leira

2015-01-01

Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

Competency-Based Medical Education: Can Both Junior Residents and Senior Residents Achieve Competence After a Sports Medicine Training Module?

PubMed

Dwyer, Tim; Wright, Sara; Kulasegaram, Kulamakan M; Theodoropoulos, John; Chahal, Jaskarndip; Wasserstein, David; Ringsted, Charlotte; Hodges, Brian; Ogilvie-Harris, Darrell

2015-12-02

Competency-based medical education as a resident-training format will move postgraduate training away from time-based training, to a model based on observable outcomes. The purpose of this study was to determine whether junior residents and senior residents could demonstrate clinical skills to a similar level, after a sports medicine rotation. All residents undertaking a three-month sports medicine rotation had to pass an Objective Structured Clinical Examination. The stations tested the fundamentals of history-taking, examination, image interpretation, differential diagnosis, informed consent, and clinical decision-making. Performance at each station was assessed with a binary station-specific checklist and an overall global rating scale, in which 1 indicated novice, 2 indicated advanced beginner, 3 indicated competent, 4 indicated proficient, and 5 indicated expert. A global rating scale was also given for each domain of knowledge. Over eighteen months, thirty-nine residents (twenty-one junior residents and eighteen senior residents) and six fellows (for a total of forty-five participants) completed the examination. With regard to junior residents and senior residents, analysis using a two-tailed t test demonstrated a significant difference (p < 0.01) in both total checklist score and overall global rating scale; the mean total checklist score (and standard deviation) was 56.15% ± 10.99% for junior residents and 71.87% ± 8.94% for senior residents, and the mean global rating scale was 2.44 ± 0.55 for junior residents and 3.79 ± 0.49 for senior residents. There was a significant difference between junior residents and senior residents for each knowledge domain, with a significance of p < 0.05 for history-taking and p < 0.01 for the remainder of the domains. Despite intensive teaching within a competency-based medical education model, junior residents were not able to demonstrate knowledge as well as senior residents, suggesting that overall clinical experience is critically important for achieving competency as measured by the Objective Structured Clinical Examination. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

Neurocognitive Functioning in Patients with 22q11.2 Deletion Syndrome: A Meta-Analytic Review.

PubMed

Moberg, Paul J; Richman, Mara J; Roalf, David R; Morse, Chelsea L; Graefe, Anna C; Brennan, Laura; Vickers, Kayci; Tsering, Wangchen; Kamath, Vidyulata; Turetsky, Bruce I; Gur, Ruben C; Gur, Raquel E

2018-06-19

The 22q11.2 deletion syndrome (22q11.2DS) is a known risk factor for development of schizophrenia and is characterized by a complex neuropsychological profile. To date, a quantitative meta-analysis examining cognitive functioning in 22q11.2DS has not been conducted. A systematic review of cross-sectional studies comparing neuropsychological performance of individuals with 22q11.2DS with age-matched healthy typically developing and sibling comparison subjects was carried out. Potential moderators were analyzed. Analyses included 43 articles (282 effects) that met inclusion criteria. Very large and heterogeneous effects were seen for global cognition (d = - 1.21) and in specific neuropsychological domains (intellectual functioning, achievement, and executive function; d range = - 0.51 to - 2.43). Moderator analysis revealed a significant role for type of healthy comparison group used (typically developing or siblings), demographics (age, sex) and clinical factors (externalizing behavior). Results revealed significant differences between pediatric and adult samples, with isolated analysis within the pediatric sample yielding large effects in several neuropsychological domains (intellectual functioning, achievement, visual memory; d range = - 0.56 to - 2.50). Large cognitive deficits in intellectual functioning and specific neuropsychological variables in individuals with 22q11.2DS represent a robust finding, but these deficits are influenced by several factors, including type of comparison group utilized, age, sex, and clinical status. These findings highlight the clinical relevance of characterizing cognitive functioning in 22q11.2DS and the importance of considering demographic and clinical moderators in future analyses.

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.

Improvement of Cerebral Hypoperfusion with Levothyroxine Therapy in Hashimoto's Encephalopathy Demonstrated by 99mTc-HMPAO-SPECT

PubMed Central

Schnedl, Wolfgang J.; Mirzaei, Siroos; Wallner-Liebmann, Sandra J.; Tafeit, Erwin; Mangge, Harald; Krause, Robert; Lipp, Rainer W.

2013-01-01

Background Hashimoto's encephalopathy (HE) is a rare immune-mediated encephalopathy associated with autoimmune Hashimoto's thyroiditis. Objectives and Methods We report on a patient with HE and significant clinical improvement correlating with an increase in cerebral blood flow demonstrated by hexamethylpropyleneamine oxime (HMPAO) single-photon emission computed tomography (SPECT). HMPAO-SPECT was performed with 740 MBq of technetium-99m-HMPAO. To demonstrate the improvement in regional cerebral blood flow, individual regions of interest were drawn around visually diminished HMPAO uptake, the lesion to reference region ratio was calculated and transverse section images and semi-quantitative measurements were performed. Results We show a 5-year follow-up with significant clinical improvement, a 10-fold reduction in autoantibodies to thyroid peroxidase and an approximately 20% improvement in cerebral blood flow with HMPAO-SPECT. Conclusion Adequate levothyroxine treatment achieving and maintaining euthyroidism should be considered as therapy to lower autoantibodies and improve clinical outcome in patients with Hashimoto's thyroiditis and encephalopathy. PMID:24783049

[Globalization in medical research].

PubMed

Ehni, H-J; Wiesing, U

2018-03-01

The globalization of clinical research is gaining momentum. In particular, emerging countries, such as Brazil, India, Russia and South Africa show a significant increase in clinical trials. This trend is generating various ethical problems, which are examined in the present article. Sometimes, generally accepted ethical rules, such as the evaluation of clinical trials by ethics commissions are not respected and sometimes conflicts are generated which are difficult to resolve. For instance, it is controversial which standard of care researchers and sponsors have to provide in an international study. These conflicts are exacerbated by a fundamental dilemma: more research on diseases prevalent in developing and emerging countries is necessary. At the same time, the protection of study participants in those countries creates particular challenges. In recent years, international commissions and guidelines have achieved significant progress in solving these conflicts; however, the further development has to be analyzed very carefully. Incentives for better research on neglected diseases have to be created. Undesirable developments and abuse have to be prevented by appropriate international ethical standards.

Mathematics deficits in adolescents with bipolar I disorder.

PubMed

Lagace, Diane C; Kutcher, Stanley P; Robertson, Heather A

2003-01-01

This study examined mathematical ability in adolescents with bipolar I disorder, compared to adolescents with major depressive disorder and psychiatrically healthy comparison subjects. Participants (N=119) included adolescents in remission from bipolar disorder (N=44) or major depressive disorder (N=30), as well as comparison subjects (N=45) with no psychiatric history. Participants were assessed with the following measures: the Wide-Range Achievement Test, Revised 2 (WRAT-R2), Peabody Individual Achievement Test, Bay Area Functional Performance Evaluation Task-Oriented Assessment (functional mathematics subtest), Test of Nonverbal Intellegence-2, and a self-report of mathematics performance. WRAT-R2 and Peabody Individual Achievement Test scores for spelling, mathematics, and reading revealed that adolescents with bipolar disorder had significantly lower achievement in mathematics, compared to subjects with major depressive disorder and comparison subjects. Results for the Test of Nonverbal Intellegence-2 were not significantly different between groups. Adolescents with bipolar disorder took significantly longer to complete the Bay Area Functional Performance Evaluation mathematics task. Significantly fewer adolescents with bipolar disorder (9%) reported above-average mathematics performance, compared with the other groups. Adolescents with remitted bipolar disorder have a specific profile of mathematics difficulties that differentiates them from both adolescents with unipolar depression and psychiatrically healthy comparison subjects. These mathematics deficits may not derive simply from more global deficits in nonverbal intelligence or executive functioning, but may be associated with neuroanatomical abnormalities that result in cognitive deficits, including a slowed response time. These deficits suggest the need for specialized assessment of mathematics as part of a comprehensive clinical follow-up treatment plan.

Care manager to control cardiovascular risk factors in primary care: the Raffaello cluster randomized trial.

PubMed

Deales, A; Fratini, M; Romano, S; Rappelli, A; Penco, M; Perna, G Piero; Beccaceci, G; Borgia, R; Palumbo, W; Magi, M; Vespasiani, G; Bronzini, M; Musilli, A; Nocciolini, M; Mezzetti, A; Manzoli, L

2014-05-01

This cluster randomized trial evaluated the efficacy of a disease and care management (D&CM) model in cardiovascular (CVD) prevention in primary care. Eligible subjects had ≥ 1 among: blood pressure ≥ 140/90 mmHg; glycated hemoglobin ≥ 7%; LDL-cholesterol ≥ 160 or ≥ 100 mg/dL (primary or secondary prevention, respectively); BMI ≥ 30; current smoking. The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans. Control group was allocated to usual-care. The main outcome was the proportion of subjects achieving recommended clinical targets for ≥ 1 of uncontrolled CVD risk factors at 12-month. During 2008-2009 we enrolled 920 subjects in the Abruzzo/Marche regions, Italy. Following the exclusion of L'Aquila due to 2009 earthquake, final analyses included 762 subjects. The primary outcome was achieved by 39.1% (95%CI: 34.2-44.2) and 25.2% (95%CI: 20.9-29.9) of subjects in the intervention and usual-care group, respectively (p < 0.001). The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension, with no differences in hypercholesterolemia, smoking status and obesity. The D&CM intervention was effective in controlling cardiovascular risk factors, in particular hypertension and diabetes. Numbers needed to treat were small. Such intervention may deserve further consideration in clinical practice. ACTRN12611000813987. Copyright © 2013 Elsevier B.V. All rights reserved.

Achieving recovery in patients with schizophrenia through psychosocial interventions: A retrospective study.

PubMed

Buonocore, Mariachiara; Bosia, Marta; Baraldi, Maria A; Bechi, Margherita; Spangaro, Marco; Cocchi, Federica; Bianchi, Laura; Guglielmino, Carmelo; Mastromatteo, Antonella R; Cavallaro, Roberto

2018-01-01

Recovery, or functional remission, represents the ultimate treatment goal in schizophrenia. Despite its importance, a standardized definition of remission is still lacking, thus reported rates significantly vary across studies. Moreover, the effects of rehabilitative interventions on recovery have not been thoroughly investigated. This study aimed to evaluate recovery in a sample of patients with chronic schizophrenia engaged in rehabilitation programs and to explore contributing factors, with a focus on sociocognitive rehabilitative interventions. Data from 104 patients with schizophrenia treated either with a standard rehabilitation program, including cognitive remediation (n = 46), or the latter plus a specific sociocognitive intervention (n = 58), and assessed for psychopathology, cognition, social cognition, and Quality of Life Scale, were retrospectively analyzed for this study. Recovery, evaluated with the Quality of Life Scale, was achieved by 56.76% of patients in our sample. While no effects were observed for clinical, cognitive, or sociocognitive variables, participation in the sociocognitive rehabilitative interventions was positively associated with recovery. Our results indicate that high rates of recovery can be achieved in patients treated with psychosocial interventions and suggest that rehabilitative programs targeting social cognition may further facilitate the process of recovery. If confirmed, these results may have relevant implications for daily clinical practice and service provision, allowing clinicians to develop and optimize specific rehabilitation programs in order to promote recovery. © 2017 The Authors. Psychiatry and Clinical Neurosciences © 2017 Japanese Society of Psychiatry and Neurology.

Clinical features and treatment outcome of non-small cell lung cancer (NSCLC) patients with uncommon or complex epidermal growth factor receptor (EGFR) mutations

PubMed Central

Fassan, Matteo; Indraccolo, Stefano; Calabrese, Fiorella; Favaretto, Adolfo; Bonanno, Laura; Polo, Valentina; Zago, Giulia; Lunardi, Francesca; Attili, Ilaria; Pavan, Alberto; Rugge, Massimo; Guarneri, Valentina; Conte, PierFranco; Pasello, Giulia

2017-01-01

Introduction Tyrosine-kinase inhibitors (TKIs) represent the best treatment for advanced non-small cell lung cancer (NSCLC) with common exon 19 deletion or exon 21 epidermal growth factor receptor mutation (EGFRm). This is an observational study investigating epidemiology, clinical features and treatment outcome of NSCLC cases harbouring rare/complex EGFRm. Results Among 764 non-squamous NSCLC cases with known EGFRm status, 26(3.4%) harboured rare/complex EGFRm. Patients receiving first-line TKIs (N = 17) achieved median Progression Free Survival (PFS) and Overall Survival (OS) of 53 (IC 95%, 2–105) and 84 (CI 95%, 27–141) weeks respectively, without significant covariate impact. Response Rate and Disease Control Rate (DCR) were 47% and 65%, respectively. Uncommon exon 19 mutations achieved longer OS and PFS and higher DCR compared with exon 18 and 20 mutations. No additional gene mutation was discovered by MassARRAY analysis. TKIs were globally well tolerated. Materials and methods A retrospective review of advanced non-squamous NSCLC harbouring rare/complex EGFRm referred to our Center between 2010 and 2015 was performed. Additional molecular pathways disregulation was explored in selected cases, through MassARRAY analysis. Conclusions Peculiar clinical features and lower TKIs sensitivity of uncommon/complex compared with common EGFRm were shown. Exon 19 EGFRm achieved the best TKIs treatment outcome, while the optimal treatment of exon 18 and 20 mutations should be further clarified. PMID:28427238

The relationship between extracurricular activities assessed during selection and during medical school and performance.

PubMed

Urlings-Strop, Louise C; Themmen, Axel P N; Stegers-Jager, Karen M

2017-05-01

Several medical schools include candidates' extracurricular activities in their selection procedure, with promising results regarding their predictive value for achievement during the clinical years of medical school. This study aims to reveal whether the better achievement in clinical training of students selected on the basis of their extracurricular activities could be explained by persistent participation in extracurricular activities during medical school (msECAs). Lottery-admitted and selected student admission groups were compared on their participation in three types of msECAs: (1) research master, (2) important board positions or (3) additional degree programme. Logistic regression was used to measure the effect of admission group on participation in any msECA, adjusted for pre-university GPA. Two-way ANCOVA was used to examine the inter-relationships between admission group, participation in msECAs and clerkship grade, with pre-university GPA as covariate. Significantly more selected students compared to lottery-admitted students participated in any msECA. Participation in msECAs was associated with a higher pre-university GPA for lottery-admitted students only, whereas participation in msECAs was associated with higher clerkship grades for selected students only. These results suggest that persistent participation in extracurricular activities of selected students favours better clinical achievement, supporting the inclusion of ECAs in the selection procedure. More insight in the rationale behind participation in extracurricular activities during medical school may explain differences found between lottery-admitted and selected students.

Mono-energy coronary angiography with a compact light source

NASA Astrophysics Data System (ADS)

Eggl, Elena; Mechlem, Korbinian; Braig, Eva; Kulpe, Stephanie; Dierolf, Martin; Günther, Benedikt; Achterhold, Klaus; Herzen, Julia; Gleich, Bernhard; Rummeny, Ernst; Noël, Peter B.; Pfeiffer, Franz; Muenzel, Daniela

2017-03-01

While conventional x-ray tube sources reliably provide high-power x-ray beams for everyday clinical practice, the broad spectra that are inherent to these sources compromise the diagnostic image quality. For a monochromatic x-ray source on the other hand, the x-ray energy can be adjusted to optimal conditions with respect to contrast and dose. However, large-scale synchrotron sources impose high spatial and financial demands, making them unsuitable for clinical practice. During the last decades, research has brought up compact synchrotron sources based on inverse Compton scattering, which deliver a highly brilliant, quasi-monochromatic, tunable x-ray beam, yet fitting into a standard laboratory. One application that could benefit from the invention of these sources in clinical practice is coronary angiography. Being an important and frequently applied diagnostic tool, a high number of complications in angiography, such as renal failure, allergic reaction, or hyperthyroidism, are caused by the large amount of iodine-based contrast agent that is required for achieving sufficient image contrast. Here we demonstrate monochromatic angiography of a porcine heart acquired at the MuCLS, the first compact synchrotron source. By means of a simulation, the CNR in a coronary angiography image achieved with the quasi-mono-energetic MuCLS spectrum is analyzed and compared to a conventional x-ray-tube spectrum. The results imply that the improved CNR achieved with a quasi-monochromatic spectrum can allow for a significant reduction of iodine contrast material.

Clinical response to dorsal duct drainage via the minor papilla in refractory obstructing chronic calcific pancreatitis

PubMed Central

Kwon, Chang-Il; Gromski, Mark A.; Sherman, Stuart; El Hajj, Ihab I.; Easler, Jeffrey J.; Watkins, James; McHenry, Lee; Lehman, Glen A.; Fogel, Evan L.

2017-01-01

Background and study aims Complete stone removal from the main pancreatic duct might not be achieved in all patients with obstructive chronic calcific pancreatitis. We report our results for endoscopic dorsal pancreatic duct (DPD) bypass of obstructing stones in the ventral pancreatic duct (VPD). Patients and methods 16 patients with obstructive chronic calcific pancreatitis were treated with a DPD bypass. Clinical success was defined as significant pain relief and no hospital admissions for pain management during the ongoing treatment period. Results Among 16 patients meeting entry criteria, 10 (62.5%) had a history of unsuccessful endoscopic therapy, and 8 had failed extracorporeal shockwave lithotripsy (ESWL). Clinical success was achieved in 12 patients (75 %). Among these responders, 10 patients (83.3 %) had markedly improved or complete pain relief after the first stent placement, which persisted throughout the follow-up period; 11 patients (91.7 %) were able to discontinue their daily analgesics. Conclusions In selected patients with obstructive chronic calcific pancreatitis, the DPD bypass may be considered as a rescue endoscopic therapy, potentially obviating the need for surgery when standard endoscopic methods and ESWL fail. PMID:28201840

Porous Titanium Wedges in Lateral Column Lengthening for Adult-Acquired Flatfoot Deformity.

PubMed

Moore, Spencer H; Carstensen, S Evan; Burrus, M Tyrrell; Cooper, Truitt; Park, Joseph S; Perumal, Venkat

2017-10-01

Lateral column lengthening (LCL) is a common procedure for reconstruction of stage II flexible adult-acquired flatfoot deformity (AAFD). The recent development of porous titanium wedges for this procedure provides an alternative to allograft and autograft. The purpose of this study was to report radiographic and clinical outcomes achieved with porous titanium wedges in LCL. A retrospective analysis of 34 feet in 30 patients with AAFD that received porous titanium wedges for LCL from January 2011 to October 2014. Deformity correction was assessed using both radiographic and clinical parameters. Radiographic correction was assessed using the lateral talo-first metatarsal angle, the talonavicular uncoverage percentage, and the first metatarsocuneiform height. The hindfoot valgus angle was measured. Patients were followed from a minimum of 6 months up to 4 years (mean 16.1 months). Postoperative radiographs demonstrated significant correction in all 3 radiographic criteria and the hindfoot valgus angle. We had no cases of nonunion, no wedge migration, and no wedges have been removed to date. The most common complication was calcaneocuboid joint pain (14.7%). Porous titanium wedges in LCL can achieve good radiographic and clinical correction of AAFD with a low rate of nonunion and other complications. Level IV: Case series.

Adoptive immunotherapy utilizing anti-CD19 chimeric antigen receptor T-cells for B-cell malignancies.

PubMed

Oh, Iekuni; Oh, Yukiko; Ohmine, Ken

2016-01-01

Genetically modified T-cells with forced expression of anti-CD19 chimeric antigen receptor (CD19 CAR) have demonstrated promising clinical results for relapsed and refractory B cell malignancies in early clinical trial settings. The first beneficial tumor regressions were identified among approximately half of CLL patients in 2011. Similarly, CD19 CAR T-cells achieved remissions in about 80% of aggressive B-cell lymphomas in 2012. Furthermore, in 2013 this cellular therapy showed an extremely high rate of efficacy against refractory CD19 positive acute lymphoid leukemia, which had been regarded as the most difficult to treat hematologic disease. Recently, despite the absence of CD19 expression by neoplastic plasma cells, patients with refractory multiple myeloma achieved stringent complete remission after this therapy coupled with high dose chemotherapy and autologous stem cell transplantation. However, there are significant toxicities. Cytokine releasing syndrome and neurotoxicity are recognized as life-threatening adverse events. Although phase I/II clinical trials have just started in Japan, given the exciting results obtained to date, this cellular therapy is expected to be a novel breakthrough immunotherapy for treating refractory B-cell malignancies.

Oral administration of French maritime pine bark extract (Flavangenol(®)) improves clinical symptoms in photoaged facial skin.

PubMed

Furumura, Minao; Sato, Noriko; Kusaba, Nobutaka; Takagaki, Kinya; Nakayama, Juichiro

2012-01-01

French maritime pine bark extract (PBE) has gained popularity as a dietary supplement in the treatment of various diseases due to its polyphenol-rich ingredients. Oligometric proanthocyanidins (OPCs), a class of bioflavonoid complexes, are enriched in French maritime PBE and have antioxidant and anti-inflammatory activity. Previous studies have suggested that French maritime PBE helps reduce ultraviolet radiation damage to the skin and may protect human facial skin from symptoms of photoaging. To evaluate the clinical efficacy of French maritime PBE in the improvement of photodamaged facial skin, we conducted a randomized trial of oral supplementation with PBE. One hundred and twelve women with mild to moderate photoaging of the skin were randomized to either a 12-week open trial regimen of 100 mg PBE supplementation once daily or to a parallel-group trial regimen of 40 mg PBE supplementation once daily. A significant decrease in clinical grading of skin photoaging scores was observed in both time courses of 100 mg daily and 40 mg daily PBE supplementation regimens. A significant reduction in the pigmentation of age spots was also demonstrated utilizing skin color measurements. Clinically significant improvement in photodamaged skin could be achieved with PBE. Our findings confirm the efficacy and safety of PBE.

Learning styles and academic achievement among undergraduate medical students in Thailand

PubMed Central

Jiraporncharoen, Wichuda; Angkurawaranon, Chaisiri; Chockjamsai, Manoch; Deesomchok, Athavudh; Euathrongchit, Juntima

2015-01-01

Purpose: This study aimed to explore the associations between learning styles and high academic achievement and to ascertain whether the factors associated with high academic achievement differed between preclinical and clinical students. Methods: A survey was conducted among undergraduate medical students in Chiang Mai University, Thailand. The Index of Learning Styles questionnaire was used to assess each student’s learning style across four domains. High academic achievement was defined as a grade point average of at least 3.0. Results: Of the 1,248 eligible medical students, 1,014 (81.3%) participated. Learning styles differed between the preclinical and clinical students in the active/reflective domain. A sequential learning style was associated with high academic achievement in both preclinical and clinical students. A reflective learning style was only associated with high academic achievement among preclinical students. Conclusion: The association between learning styles and academic achievement may have differed between preclinical and clinical students due to different learning content and teaching methods. Students should be encouraged to be flexible in their own learning styles in order to engage successfully with various and changing teaching methods across the curriculum. Instructors should be also encouraged to provide a variety of teaching materials and resources to suit different learning styles. PMID:26165948

Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome

PubMed Central

Iyer, Kishore R.; Kunecki, Marek; Boullata, Joseph I.; Fujioka, Ken; Joly, Francisca; Gabe, Simon; Pape, Ulrich-Frank; Schneider, Stéphane M.; Virgili Casas, María Nuria; Ziegler, Thomas R.; Li, Benjamin; Youssef, Nader N.; Jeppesen, Palle B.

2016-01-01

Background: In phase III clinical studies, treatment with teduglutide was associated with clinically meaningful reductions (≥20% from baseline) in parenteral support (PS; parenteral nutrition and/or intravenous fluids) requirements in adult patients with intestinal failure associated with short bowel syndrome (SBS-IF). This analysis reports clinical characteristics of patients who achieved complete independence from PS during teduglutide treatment. Materials and Methods: Post hoc analysis of adult patients who achieved complete PS independence during treatment with teduglutide 0.05 mg/kg/d. Data were pooled from 5 teduglutide clinical trials (2 phase III placebo-controlled trials [NCT00081458 and NCT00798967] and their respective extension studies [NCT00172185, NCT00930644, NCT01560403]). Descriptive statistics were used; no between-group comparisons were performed because of the small sample size and lack of comparator. Results: Of 134 patients, 16 gained oral or enteral autonomy after a median of 5 years of PS dependence and 89 weeks of teduglutide treatment. Demographic and baseline disease characteristics varied among patients (median age, 55 years; 50% men; median baseline PS volume, 5.1 L/wk; median residual small intestine length, 52.5 cm). Most patients who achieved PS independence had colon-in-continuity; however, there was no significant difference in the frequency of PS independence among patients who maintained colon-in-continuity vs those who did not. Conclusion: Findings from this post hoc analysis suggest that oral or enteral autonomy is possible for some patients with SBS-IF who are treated with teduglutide, regardless of baseline characteristics and despite long-term PS dependence. PMID:27875291

Progressive Surgical Autonomy in a Plastic Surgery Resident Clinic

PubMed Central

Scott, Jillian K.; Gao, Lani; Lee, Tara M.; Waldrop, Jimmy L.; Sargent, Larry A.; Kennedy, J. Woody; Rehm, Jason P.; Brzezienski, Mark A.

2017-01-01

Background: Resident clinics are thought to catalyze educational milestone achievement through opportunities for progressively autonomous surgical care, but studies are lacking for general plastic surgery resident clinics (PSRCs). We demonstrate the achievement of increased surgical autonomy and continuity of care in a PSRC. Methods: A retrospective review of all patients seen in a PSRC from October 1, 2010, to October 1, 2015, was conducted. Our PSRC is supervised by faculty plastic surgery attendings, though primarily run by chief residents in an accredited independent plastic surgery training program. Surgical autonomy was scored on a 5-point scale based on dictated operative reports. Graduated chief residents were additionally surveyed by anonymous online survey. Results: Thousand one hundred forty-four patients were seen in 3,390 clinic visits. Six hundred fifty-three operations were performed by 23 total residents, including 10 graduating chiefs. Senior resident autonomy averaged 3.5/5 (SD = 1.5), 3.6/5 (SD = 1.5), to 3.8/5 (SD = 1.3) in postgraduate years 6, 7, and 8, respectively. A linear mixed model analysis demonstrated that training level had a significant impact on operative autonomy when comparing postgraduate years 6 and 8 (P = 0.026). Graduated residents’ survey responses (N = 10; 100% response rate) regarded PSRC as valuable for surgical experience (4.1/5), operative autonomy (4.4/5), medical knowledge development (4.7/5), and the practice of Accreditation Council of Graduate Medical Education core competencies (4.3/5). Preoperative or postoperative continuity of care was maintained in 93.5% of cases. Conclusion: The achievement of progressive surgical autonomy may be demonstrated within a PSRC model. PMID:28607848

Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P).

PubMed

Ventura, J; Liberman, R P; Green, M F; Shaner, A; Mintz, J

1998-06-15

Accuracy in psychiatric diagnosis is critical for evaluating the suitability of the subjects for entry into research protocols and for establishing comparability of findings across study sites. However, training programs in the use of diagnostic instruments for research projects are not well systematized. Furthermore, little information has been published on the maintenance of interrater reliability of diagnostic assessments. At the UCLA Research Center for Major Mental Illnesses, a Training and Quality Assurance Program for SCID interviewers was used to evaluate interrater reliability and diagnostic accuracy. Although clinically experienced interviewers achieved better interrater reliability and overall diagnostic accuracy than neophyte interviewers, both groups were able to achieve and maintain high levels of interrater reliability, diagnostic accuracy, and interviewer skill. At the first quality assurance check after training, there were no significant differences between experienced and neophyte interviewers in interrater reliability or diagnostic accuracy. Standardization of training and quality assurance procedures within and across research projects may make research findings from study sites more comparable.

Innovative Delivery of siRNA to Solid Tumors by Super Carbonate Apatite

PubMed Central

Wu, Xin; Yamamoto, Hirofumi; Nakanishi, Hiroyuki; Yamamoto, Yuki; Inoue, Akira; Tei, Mitsuyoshi; Hirose, Hajime; Uemura, Mamoru; Nishimura, Junichi; Hata, Taishi; Takemasa, Ichiro; Mizushima, Tsunekazu; Hossain, Sharif; Akaike, Toshihiro; Matsuura, Nariaki; Doki, Yuichiro; Mori, Masaki

2015-01-01

RNA interference (RNAi) technology is currently being tested in clinical trials for a limited number of diseases. However, systemic delivery of small interfering RNA (siRNA) to solid tumors has not yet been achieved in clinics. Here, we introduce an in vivo pH-sensitive delivery system for siRNA using super carbonate apatite (sCA) nanoparticles, which is the smallest class of nanocarrier. These carriers consist simply of inorganic ions and accumulate specifically in tumors, yet they cause no serious adverse events in mice and monkeys. Intravenously administered sCA-siRNA abundantly accumulated in the cytoplasm of tumor cells at 4 h, indicating quick achievement of endosomal escape. sCA-survivin-siRNA induced apoptosis in HT29 tumors and significantly inhibited in vivo tumor growth of HCT116, to a greater extent than two other in vivo delivery reagents. With innovative in vivo delivery efficiency, sCA could be a useful nanoparticle for the therapy of solid tumors. PMID:25738937

Gas-Stabilizing Gold Nanocones for Acoustically Mediated Drug Delivery.

PubMed

Mannaris, Christophoros; Teo, Boon M; Seth, Anjali; Bau, Luca; Coussios, Constantin; Stride, Eleanor

2018-06-01

The efficient penetration of drugs into tumors is a major challenge that remains unmet. Reported herein is a strategy to promote extravasation and enhanced penetration using inertial cavitation initiated by focused ultrasound and cone-shaped gold nanoparticles that entrap gas nanobubbles. The cones are capable of initiating inertial cavitation under pressures and frequencies achievable with existing clinical ultrasound systems and of promoting extravasation and delivery of a model large therapeutic molecule in an in vitro tissue mimicking flow phantom, achieving penetration depths in excess of 2 mm. Ease of functionalization and intrinsic imaging capabilities provide gold with significant advantages as a material for biomedical applications. The cones show neither cytotoxicity in Michigan Cancer Foundation (MCF)-7 cells nor hemolytic activity in human blood at clinically relevant concentrations and are found to be colloidally stable for at least 5 d at 37 °C and several months at 4 °C. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Racial/ethnic differences in video game and Internet use among US adolescents with mental health and educational difficulties.

PubMed

Carson, Nicholas; Lê Cook, Benjamin; Chen, Chih-Nan; Alegria, Margarita

2012-01-01

Video game and Internet use can be associated with poor mental health and educational outcomes among adolescents. Racial/ethnic minority youth use these media more than White youth. Video game and Internet use among adolescents with mental health and educational difficulties may therefore differ by race/ethnicity in clinically meaningful ways. We analyzed a representative sample of 8 th grade students in the United States from the Early Childhood Longitudinal Survey-Kindergarten (N=6,700). Stratifying by gender, we assessed racial/ethnic differences in the associations between video game and Internet use, mental health, and reading and math achievement. Significant minority-White differences were identified in associations between media use and mental health and educational achievement. Video game use was relatively high among black females with prior mental health diagnoses and Asian-American males with high internalizing symptoms. Understanding video game and Internet use among racial/ethnic minority youth with mental health and educational difficulties may improve clinical practice.

Feasibility of Multiple Repeat Gamma Knife Radiosurgeries for Trigeminal Neuralgia: A Case Report and Review of the Literature

PubMed Central

Jones, Guy C.; Elaimy, Ameer L.; Demakas, John J.; Jiang, Hansi; Lamoreaux, Wayne T.; Fairbanks, Robert K.; Mackay, Alexander R.; Cooke, Barton S.; Lee, Christopher M.

2011-01-01

Treatment options for trigeminal neuralgia (TN) must be customized for the individual patient, and physicians must be aware of the medical, surgical, and radiation treatment modalities to prescribe optimal treatment courses for specific patients. The following case illustrates the potential for gamma knife radiosurgery (GKRS) to be repeated multiple times for the purpose of achieving facial pain control in cases of TN that have been refractory to other medical and surgical options, as well as prior GKRS. The patient described failed to achieve pain control with initial GKRS, as well as medical and surgical treatments, but experienced significant pain relief for a period of time with a second GKRS procedure and later underwent a third procedure. Only a small subset of patients have reportedly undergone more than two GKRS for TN; thus, further research and long-term clinical followup will be valuable in determining its usefulness in specific clinical situations. PMID:21904556

Racial/ethnic differences in video game and Internet use among US adolescents with mental health and educational difficulties

PubMed Central

Carson, Nicholas; Lê Cook, Benjamin; Chen, Chih-Nan; Alegria, Margarita

2013-01-01

Video game and Internet use can be associated with poor mental health and educational outcomes among adolescents. Racial/ethnic minority youth use these media more than White youth. Video game and Internet use among adolescents with mental health and educational difficulties may therefore differ by race/ethnicity in clinically meaningful ways. We analyzed a representative sample of 8th grade students in the United States from the Early Childhood Longitudinal Survey-Kindergarten (N=6,700). Stratifying by gender, we assessed racial/ethnic differences in the associations between video game and Internet use, mental health, and reading and math achievement. Significant minority-White differences were identified in associations between media use and mental health and educational achievement. Video game use was relatively high among black females with prior mental health diagnoses and Asian-American males with high internalizing symptoms. Understanding video game and Internet use among racial/ethnic minority youth with mental health and educational difficulties may improve clinical practice. PMID:29167696

Innovative delivery of siRNA to solid tumors by super carbonate apatite.

PubMed

Wu, Xin; Yamamoto, Hirofumi; Nakanishi, Hiroyuki; Yamamoto, Yuki; Inoue, Akira; Tei, Mitsuyoshi; Hirose, Hajime; Uemura, Mamoru; Nishimura, Junichi; Hata, Taishi; Takemasa, Ichiro; Mizushima, Tsunekazu; Hossain, Sharif; Akaike, Toshihiro; Matsuura, Nariaki; Doki, Yuichiro; Mori, Masaki

2015-01-01

RNA interference (RNAi) technology is currently being tested in clinical trials for a limited number of diseases. However, systemic delivery of small interfering RNA (siRNA) to solid tumors has not yet been achieved in clinics. Here, we introduce an in vivo pH-sensitive delivery system for siRNA using super carbonate apatite (sCA) nanoparticles, which is the smallest class of nanocarrier. These carriers consist simply of inorganic ions and accumulate specifically in tumors, yet they cause no serious adverse events in mice and monkeys. Intravenously administered sCA-siRNA abundantly accumulated in the cytoplasm of tumor cells at 4 h, indicating quick achievement of endosomal escape. sCA-survivin-siRNA induced apoptosis in HT29 tumors and significantly inhibited in vivo tumor growth of HCT116, to a greater extent than two other in vivo delivery reagents. With innovative in vivo delivery efficiency, sCA could be a useful nanoparticle for the therapy of solid tumors.

Nanofibrous hollow microspheres self-assembled from star-shaped polymers as injectable cell carriers for knee repair.

PubMed

Liu, Xiaohua; Jin, Xiaobing; Ma, Peter X

2011-05-01

To repair complexly shaped tissue defects, an injectable cell carrier is desirable to achieve an accurate fit and to minimize surgical intervention. However, the injectable carriers available at present have limitations, and are not used clinically for cartilage regeneration. Here, we report nanofibrous hollow microspheres self-assembled from star-shaped biodegradable polymers as an injectable cell carrier. The nanofibrous hollow microspheres, integrating the extracellular-matrix-mimicking architecture with a highly porous injectable form, were shown to efficiently accommodate cells and enhance cartilage regeneration, compared with control microspheres. The nanofibrous hollow microspheres also supported a significantly larger amount of, and higher-quality, cartilage regeneration than the chondrocytes-alone group in an ectopic implantation model. In a critical-size rabbit osteochondral defect-repair model, the nanofibrous hollow microspheres/chondrocytes group achieved substantially better cartilage repair than the chondrocytes-alone group that simulates the clinically available autologous chondrocyte implantation procedure. These results indicate that the nanofibrous hollow microspheres are an excellent injectable cell carrier for cartilage regeneration.

The validity of two clinical tests of visual-motor perception.

PubMed

Wallbrown, J D; Wallbrown, F H; Engin, A W

1977-04-01

The study investigated the relative efficiency of the Bender and MPD as assessors of achievement-related errors in visual-motor perception. Clinical experience with these two tests suggests that beyond first grade the MPD is more sensitive than the Bender for purposes of measuring deficits in visual-motor perception that interfere with effective classroom learning. The sample was composed of 153 third-grade children from two upper-middle-class elementary schools in a surburban school system in central Ohio. For three of the four achievement criteria, the results were clearly congruent with the hypothesis stated above. That is, SpCD errors from the MPD not only showed significantly higher negative rs with the criteria (reading vocabulary, reading comprehension, and mathematics computation) than Koppitz errors from the Bender, but also accounted for a much higher proportion of the variance in these criteria. Thus, the findings suggest that psychologists engaged in the assessment of older children seriously should consider adding the MPD to their assessment battery.

Melanoma Diagnosis

NASA Astrophysics Data System (ADS)

Horsch, Alexander

The chapter deals with the diagnosis of the malignant melanoma of the skin. This aggressive type of cancer with steadily growing incidence in white populations can hundred percent be cured if it is detected in an early stage. Imaging techniques, in particular dermoscopy, have contributed significantly to improvement of diagnostic accuracy in clinical settings, achieving sensitivities for melanoma experts of beyond 95% at specificities of 90% and more. Automatic computer analysis of dermoscopy images has, in preliminary studies, achieved classification rates comparable to those of experts. However, the diagnosis of melanoma requires a lot of training and experience, and at the time being, average numbers of lesions excised per histology-proven melanoma are around 30, a number which clearly is too high. Further improvements in computer dermoscopy systems and their competent use in clinical settings certainly have the potential to support efforts of improving this situation. In the chapter, medical basics, current state of melanoma diagnosis, image analysis methods, commercial dermoscopy systems, evaluation of systems, and methods and future directions are presented.

A Public-Private Partnership Improves Clinical Performance In A Hospital Network In Lesotho.

PubMed

McIntosh, Nathalie; Grabowski, Aria; Jack, Brian; Nkabane-Nkholongo, Elizabeth Limakatso; Vian, Taryn

2015-06-01

Health care public-private partnerships (PPPs) between a government and the private sector are based on a business model that aims to leverage private-sector expertise to improve clinical performance in hospitals and other health facilities. Although the financial implications of such partnerships have been analyzed, few studies have examined the partnerships' impact on clinical performance outcomes. Using quantitative measures that reflected capacity, utilization, clinical quality, and patient outcomes, we compared a government-managed hospital network in Lesotho, Africa, and the new PPP-managed hospital network that replaced it. In addition, we used key informant interviews to help explain differences in performance. We found that the PPP-managed network delivered more and higher-quality services and achieved significant gains in clinical outcomes, compared to the government-managed network. We conclude that health care public-private partnerships may improve hospital performance in developing countries and that changes in management and leadership practices might account for differences in clinical outcomes. Project HOPE—The People-to-People Health Foundation, Inc.

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

PubMed Central

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

2016-01-01

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

Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture.

PubMed

Yan, H W; Li, L; Wang, R C; Yang, Y; Xie, Y; Tang, J; Shi, Z Y

2017-12-01

Comparison of clinical efficacies between coracoclavicular ligament reconstruction using autologous gracilis tendon with suture anchor and clavicular hook plate for the treatment of acute Neer type II distal clavicle fracture. Both coracoclavicular reconstruction with autologous gracilis tendon and clavicular hook plate could achieve satisfactory results for treating acute Neer type II distal clavicle fracture. Acute Neer type II distal clavicle fracture patients enrolled in this prospective randomized study were divided into the coracoclavicular ligament reconstruction group (using autologous gracilis tendon and suture anchor) and the hook plate group. Clinical outcomes were evaluated by shoulder X-ray, forward flexion, abduction and external rotation angle, Constant-Murley shoulder score and pain Visual Analogue Scale (VAS) at each follow-up for up to 24 months. The current study enrolled a total of 42 acute Neer type II distal clavicle fracture patients attended our hospital from March 2010 to December 2013. All patients had achieved complete healing and followed up for an average of 26 months (range, 24-38 months). At 3-month and 6-month follow-ups, Constant-Murley score in the ligament reconstruction group was significantly higher (93.8±2.6 vs. 88.7±8.7; 95.9±2.7 vs. 93.0±7.0, P<0.05), while VAS score was poorer than those in the hook plate group (1.6±0.8 vs. 2.5±1.9; 1.1±1.0 vs. 1.6±1.7, P<0.05). Reconstruction with autologous gracilis tendon improved VAS pain score in early postoperation follow-up; while Constant-Murley score and VAS score were significantly improved in the hook plate group after the implant was removed. These suggested that both coracoclavicular reconstruction with autologous gracilis tendon and clavicular hook plate could achieve satisfactory results. Level II, low-powered prospective randomized trial. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Long-term Effectiveness of Online Anaphylaxis Education for Pharmacists

PubMed Central

Vale, Sandra; Sanfilippo, Frank M; Loh, Richard; Clifford, Rhonda M

2014-01-01

Objective. To evaluate the long-term effectiveness of an Australasian Society of Clinical Immunology and Allergy (ASCIA) anaphylaxis e-learning program compared to lectures or no training. Design. A controlled interrupted-time-series study of Australian pharmacists and pharmacy students who completed ASCIA anaphylaxis e-learning or lecture programs was conducted during 2011-2013. Effectiveness was measured using a validated test administered pretraining, posttraining, and 3 and 7 months after training. Assessment. All learning groups performed significantly better on all posttests compared to the pretest, and compared to a control group (p<0.001). The proportion of e-learners achieving the minimum standard for anaphylaxis knowledge improved from 45% at pretest to 87% at 7 months. Conclusion. The ASCIA e-learning program significantly increased anaphylaxis knowledge. The high proportion of participants achieving the minimum standard at 7 months indicates long-term knowledge change. PMID:25258441

Motivation and academic achievement in medical students.

PubMed

Yousefy, Alireza; Ghassemi, Gholamreza; Firouznia, Samaneh

2012-01-01

Despite their ascribed intellectual ability and achieved academic pursuits, medical students' academic achievement is influenced by motivation. This study is an endeavor to examine the role of motivation in the academic achievement of medical students. In this cross-sectional correlational study, out of the total 422 medical students, from 4th to final year during the academic year 2007-2008, at School of Medicine, Isfahan University of Medical Sciences, 344 participated in completion of the Inventory of School Motivation (ISM), comprising 43 items and measuring eight aspects of motivation. The gold standard for academic achievement was their average academic marks at pre-clinical and clinical levels. Data were computer analyzed by running a couple of descriptive and analytical tests including Pearson Correlation and Student's t-student. Higher motivation scores in areas of competition, effort, social concern, and task were accompanied by higher average marks at pre-clinical as well as clinical levels. However, the latter ones showed greater motivation for social power as compared to the former group. Task and competition motivation for boys was higher than for girls. In view of our observations, students' academic achievement requires coordination and interaction between different aspects of motivation.

Impact of metoprolol treatment on mental status of chronic heart failure patients with neuropsychiatric disorders

PubMed Central

Liu, Xuelu; Lou, Xueming; Cheng, Xianliang; Meng, Yong

2017-01-01

Background Metoprolol treatment is well established for chronic heart failure (CHF) patients, but the central nervous system side effects are often a potential drawback. Objective To investigate the impact of metoprolol treatment on change in mental status of CHF patients with clinical psychological disorders (such as depression, anxiety, and burnout syndrome). Methods From February 2013 to April 2016, CHF patients with clinical mental disorders received metoprolol (23.75 or 47.5 mg, qd PO, dose escalated with 23.75 mg each time until target heart rate [HR] <70 bpm was achieved) at the Second Affiliated Hospital of Kunming Medical University. Mental status was assessed by means of the Hospital Anxiety and Depression Scale (HADS) and the Copenhagen Burnout Inventory (CBI) scale. The primary outcome assessed was change in mental status of patients post-metoprolol treatment and the association with reduction in HR achieved by metoprolol. Results A total of 154 patients (median age: 66.39 years; males: n=101) were divided into eight groups on the basis of their mental status. HR decreased significantly from baseline values in all the groups to <70 bpm in the 12th month, P≤0.0001. The HADS depression and CBI scores significantly increased from baseline throughout the study frame (P≤0.0001 for all groups), but a significant decrease in the HADS anxiety score was observed in patients with anxiety (P≤0.0001 for all groups). Regression analysis revealed no significant correlation in any of the groups between the HR reduction and the change in the HADS/CBI scores, except for a change in the CBI scores of CHF patients with depression (P=0.01), which was HR dependent. Conclusion Metoprolol treatment worsens the depressive and high burnout symptoms, but affords anxiolytic benefits independent of HR reduction in CHF patients with clinical mental disorders. Hence, physicians need to be vigilant while prescribing metoprolol in CHF patients who present with mental disorders. PMID:28182127

Impact of metoprolol treatment on mental status of chronic heart failure patients with neuropsychiatric disorders.

PubMed

Liu, Xuelu; Lou, Xueming; Cheng, Xianliang; Meng, Yong

2017-01-01

Metoprolol treatment is well established for chronic heart failure (CHF) patients, but the central nervous system side effects are often a potential drawback. To investigate the impact of metoprolol treatment on change in mental status of CHF patients with clinical psychological disorders (such as depression, anxiety, and burnout syndrome). From February 2013 to April 2016, CHF patients with clinical mental disorders received metoprolol (23.75 or 47.5 mg, qd PO, dose escalated with 23.75 mg each time until target heart rate [HR] <70 bpm was achieved) at the Second Affiliated Hospital of Kunming Medical University. Mental status was assessed by means of the Hospital Anxiety and Depression Scale (HADS) and the Copenhagen Burnout Inventory (CBI) scale. The primary outcome assessed was change in mental status of patients post-metoprolol treatment and the association with reduction in HR achieved by metoprolol. A total of 154 patients (median age: 66.39 years; males: n=101) were divided into eight groups on the basis of their mental status. HR decreased significantly from baseline values in all the groups to <70 bpm in the 12th month, P ≤0.0001. The HADS depression and CBI scores significantly increased from baseline throughout the study frame ( P ≤0.0001 for all groups), but a significant decrease in the HADS anxiety score was observed in patients with anxiety ( P ≤0.0001 for all groups). Regression analysis revealed no significant correlation in any of the groups between the HR reduction and the change in the HADS/CBI scores, except for a change in the CBI scores of CHF patients with depression ( P =0.01), which was HR dependent. Metoprolol treatment worsens the depressive and high burnout symptoms, but affords anxiolytic benefits independent of HR reduction in CHF patients with clinical mental disorders. Hence, physicians need to be vigilant while prescribing metoprolol in CHF patients who present with mental disorders.

Determination of Optimal Amikacin Dosing Regimens for Pediatric Patients With Burn Wound Sepsis.

PubMed

Yu, Tian; Stockmann, Chris; Healy, Daniel P; Olson, Jared; Wead, Stephanie; Neely, Alice N; Kagan, Richard J; Spigarelli, Michael G; Sherwin, Catherine M T

2015-01-01

This study aimed to develop optimal amikacin dosing regimens for the empirical treatment of Gram-negative bacterial sepsis in pediatric patients with burn injuries. A pharmacodynamic (PD) target in which the peak concentration (Cmax) is ≥8 times the minimum inhibitory concentration (MIC) (Cmax/MIC ≥ 8) is reflective of optimal bactericidal activity and has been used to predict clinical outcomes. Population pharmacokinetic modeling was performed in NONMEM 7.2 for pediatric patients with and without burn injuries. Amikacin pharmacokinetic parameters were compared between the two groups and multiple dosing regimens were simulated using MATLAB to achieve the PD target in ≥90% of patients with burn injuries. The pharmacokinetic analysis included 282 amikacin concentrations from 70 pediatric patients with burn injuries and 99 concentrations from 32 pediatric patients without burns. A one-compartment model with first-order elimination described amikacin pharmacokinetics well for both groups. Clearance (CL) was significantly higher in patients with burn injuries than in patients without (7.22 vs 5.36 L/h, P < .001). The volume of distribution (V) was also significantly increased in patients with burn injuries (22.7 vs 18.7 L, P < .01). Weight significantly influenced amikacin CL (P < .001) and V (P < .001) for both groups. Model-based simulations showed that a higher amikacin dose (≥25 mg/kg) achieved a Cmax/MIC ≥8 in ≥90% of patients with assumed infections of organisms with an MIC = 8 mg/L. Amikacin pharmacokinetics are altered in patients with burn injuries, including a significant increase in CL and V. In simulations, increased doses (≥25 mg/kg) led to improved PD target attainment rates. Further clinical evaluation of this proposed dosing regimen is warranted to assess clinical and microbiological outcomes in pediatric patients with burn wound sepsis.

Duct-to-mucosa versus dunking techniques of pancreaticojejunostomy after pancreaticoduodenectomy: Do we need more trials? A systematic review and meta-analysis with trial sequential analysis.

PubMed

Kilambi, Ragini; Singh, Anand Narayan

2018-03-25

Pancreaticojejunostomy (PJ is the most widely used reconstruction technique after pancreaticoduodenectomy. Despite several randomized trials, the ideal technique of pancreaticojejunostomy remains debatable. We planned a meta-analysis of randomized trials comparing the two most common techniques of PJ (duct-to-mucosa and dunking) to identify the best available evidence in the current literature. We searched the Pubmed/Medline, Web of science, Science citation index, Google scholar and Cochrane Central Register of Controlled Trials electronic databases till October 2017 for all English language randomized trials comparing the two approaches. Statistical analysis was performed using Review Manager (RevMan), Version 5.3. Copenhagen: The Nordic Cochrane Center, The Cochrane Collaboration, 2014 and results were expressed as odds ratio for dichotomous and mean difference for continuous variables. P-value ≤ 0.05 was considered significant. Trial sequential analysis was performed using TSA version 0.9.5.5 (Copenhagen: The Copenhagen Trial Unit, Center for Clinical Intervention Research, 2016). A total of 8 trials were included, with a total of 1043 patients (DTM: 518; Dunking: 525). There was no significant difference between the two groups in terms of overall as well as clinically relevant POPF rate. Similarly, both groups were comparable for the secondary outcomes. Trial sequential analysis revealed that the required information size had been crossed without achieving a clinically significant difference for overall POPF; and though the required information size had not been achieved for CR-POPF, the current data has already crossed the futility line for CR-POPF with a 10% risk difference, 80% power and 5% α error. This meta-analysis found no significant difference between the two techniques in terms of overall and CR-POPF rates. Further, the existing evidence is sufficient to conclude lack of difference and further trials are unlikely to result in any change in the outcome. (CRD42017074886). © 2018 Wiley Periodicals, Inc.

Gait Improvements After Peroneal or Tibial Nerve Transfer in Patients with Foot Drop: A Retrospective Study

PubMed Central

Somasundaram, Chandra

2017-01-01

Background: Injury to the common peroneal nerve disrupts the motor control pathway to ankle dorsiflexors and evertors, as well as toe extensors, resulting in pathological gait and foot drop. Direct external compression on the fibular head is the most frequent cause of peroneal nerve impairment and has poor prognosis. Methods and Patients: Here, we report the surgical outcome of 21 patients with foot drop (9 males and 12 females) who underwent nerve transfer procedure of either the superficial peroneal nerve or the tibial nerve fascicles to the motor branch of the tibialis anterior and to the deep peroneal nerve. They had at least 6 months postoperative follow-up (mean = 17; range, 6-32 months). Results: Among 21 patients who had no ankle dorsiflexion (BMRC 0/5) preoperatively, 9 patients had successful restoration of ankle dorsiflexion (BMRC 4 to 4+/5), 7 patients had BMRC 2 to 3+/5, and 4 patients had no or poor restoration of dorsiflexion (BMRC 0 to 1+/5) but achieved good ankle eversion (BMRC 3 to 4+/5). Overall statistically significant clinical improvement of ankle dorsiflexion and eversion from preoperative BMRC grade 2.6 ± 0.5 to postoperative BMRC grade 3.6 ± 0.7 (P = .0000004) was achieved. Conclusion: Overall statistically significant clinical improvement of ankle dorsiflexion and eversion was achieved in 80% of our study patients. Most of these patients gained antigravity and were able to walk with minimal steppage gait. In the other 4 patients (20%), there was good improvement in ankle eversion but poor or no ankle dorsiflexion. PMID:29018508

Gait Improvements After Peroneal or Tibial Nerve Transfer in Patients with Foot Drop: A Retrospective Study.

PubMed

Nath, Rahul K; Somasundaram, Chandra

2017-01-01

Background: Injury to the common peroneal nerve disrupts the motor control pathway to ankle dorsiflexors and evertors, as well as toe extensors, resulting in pathological gait and foot drop. Direct external compression on the fibular head is the most frequent cause of peroneal nerve impairment and has poor prognosis. Methods and Patients: Here, we report the surgical outcome of 21 patients with foot drop (9 males and 12 females) who underwent nerve transfer procedure of either the superficial peroneal nerve or the tibial nerve fascicles to the motor branch of the tibialis anterior and to the deep peroneal nerve. They had at least 6 months postoperative follow-up (mean = 17; range, 6-32 months). Results: Among 21 patients who had no ankle dorsiflexion (BMRC 0/5) preoperatively, 9 patients had successful restoration of ankle dorsiflexion (BMRC 4 to 4+/5), 7 patients had BMRC 2 to 3+/5, and 4 patients had no or poor restoration of dorsiflexion (BMRC 0 to 1+/5) but achieved good ankle eversion (BMRC 3 to 4+/5). Overall statistically significant clinical improvement of ankle dorsiflexion and eversion from preoperative BMRC grade 2.6 ± 0.5 to postoperative BMRC grade 3.6 ± 0.7 ( P = .0000004) was achieved. Conclusion: Overall statistically significant clinical improvement of ankle dorsiflexion and eversion was achieved in 80% of our study patients. Most of these patients gained antigravity and were able to walk with minimal steppage gait. In the other 4 patients (20%), there was good improvement in ankle eversion but poor or no ankle dorsiflexion.

The results of therapeutic plasma exchange in patients with severe hyperthyroidism: a retrospective multicenter study.

PubMed

Keklik, Muzaffer; Kaynar, Leylagul; Yilmaz, Mehmet; Sivgin, Serdar; Solmaz, Musa; Pala, Cigdem; Aribas, Sulbiye; Akyol, Gulsah; Unluhizarci, Kursat; Cetin, Mustafa; Eser, Bulent; Unal, Ali

2013-06-01

Hyperthyroidism characterized by elevated serum levels of circulating thyroid hormones. The aim of hyperthyroidism treatment is to achieve a euthyroid state as soon as possible and to maintain euthyroid status. However, drug withdrawal and utilization of alternative therapies are needed in cases in which leucopenia or impairment in liver functions is observed during medical therapy. In the present study, we aimed to present our cases which underwent therapeutic plasma exchange (TPE) due to severe hyperthyroidism. The results of 22 patients who underwent therapeutic plasma exchange due to hyperthyroidism in Apheresis Units of Erciyes University and Gaziantep University, between 2006 and 2012, were retrospectively reviewed. These cases had severe thyrotoxic values despite anti-thyroid drug use. After TPE, we observed a significant decrease in free thyroxin (FT4) (p<0.001) and free triiodotyhronin (FT3) (p<0.004) levels. There was statistically significant increase in the mean values of TSH levels after TPE (p<0.001). Clinical improvement was achieved in hyperthyroidism by TPE in 20 cases (91%). Both FT3 and FT4 levels remained above the normal limits in two of 22 patients. TPE should be considered as an effective and safe therapeutic option to achieve euthyroid state before surgery or radioactive iodine treatment. TPE is a useful option in cases with severe hyperthyroidism unresponsive to anti-thyroid agents and in those with clinical manifestations of cardiac failure and in patients with severe adverse events during anti-thyroid therapy. Copyright © 2013 Elsevier Ltd. All rights reserved.

Accurate discrimination of Alzheimer's disease from other dementia and/or normal subjects using SPECT specific volume analysis

NASA Astrophysics Data System (ADS)

Iyatomi, Hitoshi; Hashimoto, Jun; Yoshii, Fumuhito; Kazama, Toshiki; Kawada, Shuichi; Imai, Yutaka

2014-03-01

Discrimination between Alzheimer's disease and other dementia is clinically significant, however it is often difficult. In this study, we developed classification models among Alzheimer's disease (AD), other dementia (OD) and/or normal subjects (NC) using patient factors and indices obtained by brain perfusion SPECT. SPECT is commonly used to assess cerebral blood flow (CBF) and allows the evaluation of the severity of hypoperfusion by introducing statistical parametric mapping (SPM). We investigated a total of 150 cases (50 cases each for AD, OD, and NC) from Tokai University Hospital, Japan. In each case, we obtained a total of 127 candidate parameters from: (A) 2 patient factors (age and sex), (B) 12 CBF parameters and 113 SPM parameters including (C) 3 from specific volume analysis (SVA), and (D) 110 from voxel-based analysis stereotactic extraction estimation (vbSEE). We built linear classifiers with a statistical stepwise feature selection and evaluated the performance with the leave-one-out cross validation strategy. Our classifiers achieved very high classification performances with reasonable number of selected parameters. In the most significant discrimination in clinical, namely those of AD from OD, our classifier achieved both sensitivity (SE) and specificity (SP) of 96%. In a similar way, our classifiers achieved a SE of 90% and a SP of 98% in AD from NC, as well as a SE of 88% and a SP of 86% in AD from OD and NC cases. Introducing SPM indices such as SVA and vbSEE, classification performances improved around 7-15%. We confirmed that these SPM factors are quite important for diagnosing Alzheimer's disease.

The Predictive Value of Ultrasound Learning Curves Across Simulated and Clinical Settings.

PubMed

Madsen, Mette E; Nørgaard, Lone N; Tabor, Ann; Konge, Lars; Ringsted, Charlotte; Tolsgaard, Martin G

2017-01-01

The aim of the study was to explore whether learning curves on a virtual-reality (VR) sonographic simulator can be used to predict subsequent learning curves on a physical mannequin and learning curves during clinical training. Twenty midwives completed a simulation-based training program in transvaginal sonography. The training was conducted on a VR simulator as well as on a physical mannequin. A subgroup of 6 participants underwent subsequent clinical training. During each of the 3 steps, the participants' performance was assessed using instruments with established validity evidence, and they advanced to the next level only after attaining predefined levels of performance. The number of repetitions and time needed to achieve predefined performance levels were recorded along with the performance scores in each setting. Finally, the outcomes were correlated across settings. A good correlation was found between time needed to achieve predefined performance levels on the VR simulator and the physical mannequin (Pearson correlation coefficient .78; P < .001). Performance scores on the VR simulator correlated well to the clinical performance scores (Pearson correlation coefficient .81; P = .049). No significant correlations were found between numbers of attempts needed to reach proficiency across the 3 different settings. A post hoc analysis found that the 50% fastest trainees at reaching proficiency during simulation-based training received higher clinical performance scores compared to trainees with scores placing them among the 50% slowest (P = .025). Performances during simulation-based sonography training may predict performance in related tasks and subsequent clinical learning curves. © 2016 by the American Institute of Ultrasound in Medicine.

Single Delivery of High-Diversity Fecal Microbiota Preparation by Colonoscopy Is Safe and Effective in Increasing Microbial Diversity in Active Ulcerative Colitis.

PubMed

Jacob, Vinita; Crawford, Carl; Cohen-Mekelburg, Shirley; Viladomiu, Monica; Putzel, Gregory G; Schneider, Yecheskel; Chabouni, Fatiha; OʼNeil, Sarah; Bosworth, Brian; Woo, Viola; Ajami, Nadim J; Petrosino, Joseph F; Gerardin, Ylaine; Kassam, Zain; Smith, Mark; Iliev, Iliyan D; Sonnenberg, Gregory F; Artis, David; Scherl, Ellen; Longman, Randy S

2017-06-01

Recent trials suggest fecal microbiota transplantation (FMT) with repeated enemas and high-diversity FMT donors is a promising treatment to induce remission in ulcerative colitis. We designed a prospective, open-label pilot study to assess the safety, clinical efficacy, and microbial engraftment of single FMT delivery by colonoscopy for active ulcerative colitis using a 2-donor fecal microbiota preparation (FMP). Safety and clinical endpoints of response, remission, and mucosal healing at week 4 were assessed. Fecal DNA and rectal biopsies were used to characterize the microbiome and mucosal CD4 T cells, respectively, before and after FMT. Of the 20 patients enrolled in this study, 7 patients (35%) achieved a clinical response by week 4. Three patients (15%) were in remission at week 4 and 2 of these patients (10%) achieved mucosal healing. Three patients (15%) required escalation of care. No serious adverse events were observed. Microbiome analysis revealed that restricted diversity of recipients pre-FMT was significantly increased by high-diversity 2-donor FMP. The microbiome of recipients post-transplant was more similar to the donor FMP than the pretransplant recipient sample in both responders and nonresponders. Notably, donor composition correlated with clinical response. Mucosal CD4 T-cell analysis revealed a reduction in both Th1 and regulatory T-cells post-FMT. High-diversity, 2-donor FMP delivery by colonoscopy seems safe and effective in increasing fecal microbial diversity in patients with active ulcerative colitis. Donor composition correlated with clinical response and further characterization of immunological parameters may provide insight into factors influencing clinical outcome.

An observational study of the effectiveness of alternative care providers in the management of obstructive sleep apnea.

PubMed

Pendharkar, Sachin R; Dechant, Anthony; Bischak, Diane P; Tsai, Willis H; Stevenson, Ann-Marie; Hanly, Patrick J

2016-04-01

Alternative care providers have been proposed as a substitute for physician-based management of obstructive sleep apnea. The purpose of this study was to describe the clinical course of patients with a new diagnosis of obstructive sleep apnea who were treated with continuous positive airway pressure and followed by alternative care providers at a tertiary care sleep clinic. It was hypothesized that care by alternative care providers would result in improvement of daytime sleepiness and satisfactory treatment adherence, and that a specific number of follow-up visits could be identified after which clinical outcomes no longer improved. The Epworth Sleepiness Scale score was measured for each patient at baseline and at each alternative care provider visit. Patients were discharged when they demonstrated a significant improvement in sleepiness and were adherent to therapy. The Epworth Sleepiness Scale score decreased by 3.9 points from baseline to discharge. Patients with three or more visits required more follow-up time to achieve the same clinical improvement as those with only two visits. Continuous positive airway pressure adherence was comparable to previous studies of physician-led care and improved with ongoing alternative care provider follow-up. The current results suggest that clinical care by alternative care providers leads to continued improvements in sleepiness in patients with obstructive sleep apnea who are treated with continuous positive airway pressure, and that a minority of patients require longer follow-up to achieve a satisfactory clinical response to therapy. © 2015 European Sleep Research Society.

Second-look arthroscopic assessment and clinical results of modified pull-out suture for posterior root tear of the medial meniscus.

PubMed

Cho, Jin-Ho; Song, Jae-Gwang

2014-06-01

To identify the structural integrity of the healing site after arthroscopic repair of a posterior root tear of the medial meniscus by second-look arthroscopy and to determine the clinical relevance of the findings. From January 2005 to December 2010, 20 consecutive patients underwent arthroscopic modified pull-out suture repair for a posterior root tear of the medial meniscus. Thirteen patients were available for second-look arthroscopic evaluation. The healing status of the medial meniscus was classified as complete healing, lax healing, scar tissue healing, and failed healing. We evaluated the correlation between the clinical symptoms and second-look arthroscopic findings. Clinical evaluation was based on the Lysholm knee scores and Hospital for Special Surgery (HSS) scores. There were 4 cases of complete healing, 4 lax healing, 4 scar tissue healing, and 1 failed healing. The healing status of the repaired meniscus appeared to be related to the clinical symptoms. Patients who achieved complete tissue healing had no complaint. The healing status exhibited no relationship with age, mechanical axis, degree of subluxation, and symptom duration. The mean Lysholm score improved from 34.7 preoperatively to 75.6 at follow-up and the mean HSS score also significantly increased from 33.5 to 82.2. We achieved 4 complete and 8 partial healing (lax or scar) of the medial meniscus in this retrospective case series of posterior horn meniscus root repairs performed by 1 surgeon. Further research is needed to clarify why all patients showed clinical improvement despite findings of partial healing on second-look arthroscopy.

"People like numbers": a descriptive study of cognitive assessment methods in clinical practice for Aboriginal Australians in the Northern Territory.

PubMed

Dingwall, Kylie M; Pinkerton, Jennifer; Lindeman, Melissa A

2013-01-31

Achieving culturally fair assessments of cognitive functioning for Aboriginal people is difficult due to a scarcity of appropriately validated tools for use with this group. As a result, some Aboriginal people with cognitive impairments may lack fair and equitable access to services. The objective of this study was to examine current clinical practice in the Northern Territory regarding cognitive assessment for Aboriginal people thereby providing some guidance for clinicians new to this practice setting. Qualitative enquiry was used to describe practice context, reasons for assessment, and current practices in assessing cognition for Aboriginal Australians. Semi-structured interviews were conducted with 22 clinicians working with Aboriginal clients in central and northern Australia. Results pertaining to assessment methods are reported. A range of standardised tests were utilised with little consistency across clinical practice. Nevertheless, it was recognised that such tests bear severe limitations, requiring some modification and significant caution in their interpretation. Clinicians relied heavily on informal assessment or observations, contextual information and clinical judgement. Cognitive tests developed specifically for Aboriginal people are urgently needed. In the absence of appropriate, validated tests, clinicians have relied on and modified a range of standardised and informal assessments, whilst recognising the severe limitations of these. Past clinical training has not prepared clinicians adequately for assessing Aboriginal clients, and experience and clinical judgment were considered crucial for fair interpretation of test scores. Interpretation guidelines may assist inexperienced clinicians to consider whether they are achieving fair assessments of cognition for Aboriginal clients.

Influence of clinical experience of the Macintosh laryngoscope on performance with the Pentax-AWS Airway Scope(®), a rigid video-laryngoscope, by paramedics in Japan.

PubMed

Ota, Kohei; Sadamori, Takuma; Kusunoki, Shinji; Otani, Tadatsugu; Tamura, Tomoko; Une, Kazunobu; Kida, Yoshiko; Itai, Junji; Iwasaki, Yasumasa; Hirohashi, Nobuyuki; Nakao, Masakazu; Tanigawa, Koichi

2015-10-01

We sought to establish the clinical utility of the Pentax-AWS Airway Scope(®) (AWS) when used by paramedics to intubate the trachea, and to evaluate whether their performance was influenced by previous clinical experience with the Macintosh laryngoscope (ML). Twenty paramedics attempted tracheal intubation using the AWS in five patients each in the operating room. We recorded the success rate, the number of intubation attempts, and the time for intubation and adverse events, and compared these based on the paramedics' previous clinical experience with the ML. Ten paramedics had no prior clinical experience of the ML (group A) and 10 had used it on more than 30 occasions (group B). The intubation success rate was 99 % (99/100). Notably, 96 % (47/49) of intubations were achieved on the first attempt by the inexperienced paramedics in group A, compared with 64 % (32/50) by the experienced paramedics in group B (p = 0.0001). The time to intubation (mean ± SD) was significantly shorter in group A than in group B (37 ± 24 vs. 48 ± 21 s, p = 0.002). There were marked variations in the times taken to intubate, but no apparent improvement as the intubators gained experience between their first and fifth cases. No complications were encountered in either group. We found that paramedics could achieve a high tracheal intubation success rate using the AWS independent of previous airway management experience. Better intubation performance with the AWS was observed in paramedics without clinical experience with the ML.

Planning for positive clinical & financial returns with telemonitoring.

PubMed

Wright, Kristy

2003-10-01

Telemonitoring is a burgeoning market in the home care industry. Making the decision to invest in telemonitoring technology can be difficult in the best situations. The financial investment is significant, the risks can be high, and the need to achieve a positive return is critical to future success. In spite of the risks, this relatively new technology in home care holds the promise for the redefinition of the industry.

Randomized Clinical Trial of Cognitive Behavioral Social Skills Training for Schizophrenia: Improvement in Functioning and Experiential Negative Symptoms

PubMed Central

Granholm, Eric; Holden, Jason; Link, Peter C.; McQuaid, John R.

2014-01-01

Objective Identifying treatments to improve functioning and reduce negative symptoms in consumers with schizophrenia is of high public health significance. Method In this randomized clinical trial, participants with schizophrenia or schizoaffective disorder (N=149) were randomly assigned to cognitive behavioral social skills training (CBSST) or an active goal-focused supportive contact (GFSC) control condition. CBSST combined cognitive behavior therapy with social skills training and problem solving training to improve functioning and negative symptoms. GFSC was weekly supportive group therapy focused on setting and achieving functioning goals. Blind raters assessed functioning (primary outcome: Independent Living Skills Survey (ILSS)), CBSST skill knowledge, positive and negative symptoms, depression, and defeatist performance attitudes. Results In mixed-effects regression models in intent-to-treat analyses, CBSST skill knowledge, functioning, amotivation/asociality negative symptoms and defeatist performance attitudes improved significantly more in CBSST relative to GFSC. In both treatment groups, comparable improvements were also found for positive symptoms and a performance-based measure of social competence. Conclusions The results suggest CBSST is an effective treatment to improve functioning and experiential negative symptoms in consumers with schizophrenia, and both CBSST and supportive group therapy that is actively focused on setting and achieving functioning goals can improve social competence and reduce positive symptoms. PMID:24911420

Action learning: an effective way to improve cancer-related pain management.

PubMed

Kasasbeh, Mohammed Ali Mohammed; McCabe, Catherine; Payne, Sheila

2017-11-01

To evaluate the efficacy of action learning for improving cancer related pain management in the acute healthcare settings. Despite the prevalent use of action learning in private, public, clinical and non-clinical settings, no studies were found in the literature that either examined cancer pain management or used action learning as an approach to improve patient care in acute healthcare settings. An intervention pre - posttest design was adopted using an action learning programme (ALPs) as the intervention. Healthcare professionals' knowledge, attitudes and practice were assessed and evaluated before and after the implementation of the six-month ALPs. A pre and post audit and survey were conducted for data collection. The data were collected from the entire population of 170 healthcare professionals in one healthcare organisation. The management of cancer related pain improved significantly following the intervention. Significant improvement were also seen in healthcare professionals' knowledge, attitudes with improved cancer related pain management as a consequence of this. Despite many organisational challenges to practice development and collaborative working in healthcare settings there is evidence that action learning can achieve positive outcomes for improving CRP and supporting collaborative working. Action learning needs to be considered as a strategy for achieving high quality standards. © 2016 John Wiley & Sons Ltd.

Vernakalant selectively prolongs atrial refractoriness with no effect on ventricular refractoriness or defibrillation threshold in pigs.

PubMed

Bechard, Jeff; Gibson, John Ken; Killingsworth, Cheryl R; Wheeler, Jeffery J; Schneidkraut, Marlowe J; Huang, Jian; Ideker, Raymond E; McAfee, Donald A

2011-03-01

Vernakalant is a novel antiarrhythmic agent that has demonstrated clinical efficacy for the treatment of atrial fibrillation. Vernakalant blocks, to various degrees, cardiac sodium and potassium channels with a pattern that suggests atrial selectivity. We hypothesized, therefore, that vernakalant would affect atrial more than ventricular effective refractory period (ERP) and have little or no effect on ventricular defibrillation threshold (DFT). Atrial and ventricular ERP and ventricular DFT were determined before and after treatment with vernakalant or vehicle in 23 anesthetized male mixed-breed pigs. Vernakalant was infused at a rate designed to achieve stable plasma levels similar to those in human clinical trials. Atrial and ventricular ERP were determined by endocardial extrastimuli delivered to the right atria or right ventricle. Defibrillation was achieved using external biphasic shocks delivered through adhesive defibrillation patches placed on the thorax after 10 seconds of electrically induced ventricular fibrillation. The DFT was estimated using the Dixon "up-and-down" method. Vernakalant significantly increased atrial ERP compared with vehicle controls (34 ± 8 versus 9 ± 7 msec, respectively) without significantly affecting ventricular ERP or DFT. This is consistent with atrial selective actions and supports the conclusion that vernakalant does not alter the efficacy of electrical defibrillation.

Impact Of Health Care Delivery System Innovations On Total Cost Of Care.

PubMed

Smith, Kevin W; Bir, Anupa; Freeman, Nikki L B; Koethe, Benjamin C; Cohen, Julia; Day, Timothy J

2017-03-01

Using delivery system innovations to advance health care reform continues to be of widespread interest. However, it is difficult to generalize about the success of specific types of innovations, since they have been examined in only a few studies. To gain a broader perspective, we analyzed the results of forty-three ambulatory care programs funded by the first round of the Center for Medicare and Medicaid Innovation's Health Care Innovations Awards. The innovations' impacts on total cost of care were estimated by independent evaluators using multivariable difference-in-differences models. Through the first two years, most of the innovations did not show a significant effect on total cost of care. Using meta-regression, we assessed the effects on costs of five common components of these innovations. Innovations that used health information technology or community health workers achieved the greatest cost savings. Savings were also relatively large in programs that targeted clinically fragile patients-clinically complex populations at risk for disease progression. While the magnitude of these effects was often substantial, none achieved conventional levels of significance in our analyses. Meta-analyses of a larger number of delivery system innovations are needed to more clearly establish their potential for patient care cost savings. Project HOPE—The People-to-People Health Foundation, Inc.

Day surgery and recovery in women with a suspicious breast lesion: evaluation of a psychoeducational nursing intervention.

PubMed

Allard, Nicole

2006-01-01

The study assessed whether a nursing intervention based on self-regulation theory, the Attentional Focus and Symptom Management Intervention (AFSMI), could help women who underwent day surgery for breast cancer to achieve better pain management and decreased emotional distress. The sample consisted of 117 patients with breast cancer who were outpatients and undergoing surgery as part of the initial treatment for their cancer. All subjects were interviewed at three different occasions. The subjects were randomized into the experimental group (n = 61) or the usual care group (control, n = 56). The subjects in the experimental group received the intervention in two sessions, 3-4 days and 10-11 days after surgery. The outcomes were the subjects' pain and emotional distress. Results showed significant differences between the experimental and control group at post-test on home management, total mood disturbance, confusion and tension scores implying that the intervention was effective in achieving these outcomes. Clinical significance has illustrated that a nursing intervention applied during immediate recovery of breast cancer surgery is quite clinically relevant to reduce emotional distress. Self-regulation theory could effectively be used as a guide in developing nursing intervention programs in practice for patients with cancer undergoing day surgery as a primary treatment.

Cochlear Implantation in Patients With CHARGE Syndrome.

PubMed

Rah, Yoon Chan; Lee, Ji Young; Suh, Myung-Whan; Park, Moo Kyun; Lee, Jun Ho; Chang, Sun O; Oh, Seung-Ha

2016-11-01

To determine the optimal surgical approach for cochlear implantation (CI) preoperatively based on the spatial relation of a displaced facial nerve (FN) and middle ear structures and to analyze clinical outcomes of CHARGE syndrome. Facial nerve displacement and associated deviation of inner ear structures were analyzed in 13 patients (17 ears) with CHARGE syndrome who underwent CI. Surgical accessibility through the facial recess was assessed based on anatomical landmarks. Postoperative speech performance and associated clinical characteristics were analyzed. The most consistently identified ear anomalies were semicircular canal aplasia (100%), ossicular anomaly (100%), and vestibular hypoplasia (88%). Facial nerve displacement was found in 77% of cases (anteroinferior: 47%, anterior: 24%, inferior: 6%). The width of available surgical space around facial recess was significantly greater in cases of facial recess approach (2.85 ± 0.9 mm) than those of alternative approach (0.12 ± 0.29 mm, P = .02). Postoperatively, 53% achieved better than category 4 on the categories of auditory perception (CAP) scale. The CAP category was significantly correlated with internal auditory canal diameter (P = .025) and did not differ according to the applied surgical approach. Preoperative determination of surgical accessibility through facial recess would be useful for safe surgical approach, and successful hearing rehabilitation was achievable by applying appropriate surgical approaches. © The Author(s) 2016.

Helminths and Immunological Tolerance

PubMed Central

Johnston, Chris J.C.; McSorley, Henry J.; Anderton, Stephen M.; Wigmore, Stephen J.; Maizels, Rick M.

2014-01-01

Current immunosuppression regimens for solid-organ transplantation have shown disappointing efficacy in the prevention of chronic allograft rejection and carry unacceptable risks including toxicity, neoplasia, and life-threatening infection. Achievement of immunological tolerance (long-term antigen unresponsiveness in an immunocompetent host) presents the exciting prospect of freedom from immunosuppression for transplant recipients. It is now 60 years since the first demonstration of immunological tolerance in animal models of transplantation, but translation into routine clinical practice remains elusive. Helminth parasites may provide novel strategies toward achieving this goal. Helminths are remarkably successful parasites: they currently infect more than one quarter of the world’s population. It is now well established that the parasites’ success is the result of active immunomodulation of their hosts’ immune response. Although this primarily secures ongoing survival of the parasites, helminth-induced immunomodulation can also have a number of benefits for the host. Significant reductions in the prevalence of allergy and autoimmune conditions among helminth-infected populations are well recognized and there is now a significant body of evidence to suggest that harmful immune responses to alloantigens may be abrogated as well. Here, we review all existing studies of helminth infection and transplantation, explore the mechanisms involved, and discuss possible avenues for future translation to clinical practice. PMID:24025322

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

PubMed

Kotsias, Andreas; Mularski, Sven; Kühn, Björn; Hanna, Michael; Suess, Olaf

2017-01-01

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium. This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 18 months. A post hoc comparison was made to closely matched patients from another similar trial treated with identically designed, empty, uncoated PEEK cages. There were 49 of 50 patients (98%) who met the MCID of 3+ points of improvement on VAS pain or had an 18-month VAS ≤ 1. Yet even by 18 months post-op, only 40 of 50 (80%) PEEK + Ti patients achieved complete bony fusion. The PEEK + Ti group ( n  = 49) seemed to have somewhat better fusion scores and significantly better pain relief at 6 M than the matched controls ( n  = 49), but these differences did not persist at 12 M or 18 M. Patients (with either implant) who achieved complete bony fusion had significantly better improvement of pain at 6 M and disability at 6 M and 12 M than patients that remained unfused. ACDF is effective treatment for cervical myelopathy and radiculopathy. Although this and other studies show that titanium fuses better, partial coating of a PEEK cage does not improve the fusion rate sufficiently or confer other lasting clinical benefit. PEEK cages fully coated with titanium should be tested in prospective randomized comparative trials. Prospective, multicenter, single-arm clinical observational study without an individual Trial registration number. Study design and post hoc data analysis according to the "PIERCE-PEEK study", ISRCTN42774128, retrospectively registered 14 April 2009.

MRI predictors of clinical success in MR-guided focused ultrasound (MRgFUS) treatments of uterine fibroids: results from a single centre.

PubMed

Mindjuk, Irene; Trumm, Christoph G; Herzog, Peter; Stahl, Robert; Matzko, Matthias

2015-05-01

To assess the technical and clinical results of MRgFUS treatment and factors affecting clinical treatment success. A total of 252 women (mean age, 42.1 ± 6.9 years) with uterine fibroids underwent MRgFUS. All patients underwent MRI before treatment. Results were evaluated with respect to post-treatment nonperfused volume (NPV), symptom severity score (SSS), reintervention rate, pregnancy and safety data. NPV ratio was significantly higher in fibroids characterized by low signal intensity in contrast-enhanced T1-weighted fat saturated MR images and in fibroids distant from the spine (>3 cm). NPV ratio was lower in fibroids with septations, with subserosal component and in skin-distant fibroids (p < 0.001). NPV ratio was highly correlated with clinical success: NPV of more than 80 % resulted in clinical success in more than 80 % of patients. Reintervention rate was 12.7 % (mean follow-up time, 19.4 ± 8 months; range, 3-38). Expulsion of fibroids (21 %) was significantly correlated with a high clinical success rate. No severe adverse events were reported. Adequate patient selection and correct treatment techniques, based on the learning curve of this technology, combined with technical advances of the system, lead to higher clinical success rates with low complications rate, comparable to other uterine-sparing treatment options. • MRgFUS appears to be a valid alternative to other uterus-preserving therapies • Patient selection is a significant factor in achieving high NPV ratios • MRI screening parameters correlate with the amount of fibroid ablation in MRgFUS • NPV results of more than 80 % correlate with higher clinical success rates.

Why Current Statistics of Complementary Alternative Medicine Clinical Trials is Invalid.

PubMed

Pandolfi, Maurizio; Carreras, Giulia

2018-06-07

It is not sufficiently known that frequentist statistics cannot provide direct information on the probability that the research hypothesis tested is correct. The error resulting from this misunderstanding is compounded when the hypotheses under scrutiny have precarious scientific bases, which, generally, those of complementary alternative medicine (CAM) are. In such cases, it is mandatory to use inferential statistics, considering the prior probability that the hypothesis tested is true, such as the Bayesian statistics. The authors show that, under such circumstances, no real statistical significance can be achieved in CAM clinical trials. In this respect, CAM trials involving human material are also hardly defensible from an ethical viewpoint.

Toward Elimination of Hepatitis B Virus Using Novel Drugs, Approaches, and Combined Modalities.

PubMed

Boucle, Sebastien; Bassit, Leda; Ehteshami, Maryam; Schinazi, Raymond F

2016-11-01

Hepatitis B virus (HBV) causes significant morbidity and mortality worldwide. The majority of chronically infected individuals do not achieve a functional and complete cure. Treated persons who achieve a long-term sustained virologic response (undetectable HBV DNA), are still at high risk of developing morbidity and mortality from liver complications. This review focuses on novel, mechanistically diverse anti-HBV therapeutic strategies currently in development or in clinical evaluation, and highlights new combination strategies that may contribute to full elimination of HBV DNA and covalently closed circular DNA from the infected liver, leading to a complete cure of chronic hepatitis B. Copyright © 2016 Elsevier Inc. All rights reserved.

Mitral stenosis due to dynamic clip-leaflet interaction during the MitraClip procedure: Case report and review of current knowledge.

PubMed

Singh, Gagan D; Smith, Thomas W; Rogers, Jason H

2017-06-01

The goal of MitraClip therapy is to achieve mitral regurgitation reduction without iatrogenic creation of clinically significant MS. In some series, up to 35% of patients are left with mild MS. There are many contributors to the final transmitral gradient achieved in patients undergoing MitraClip therapy. Additionally, there are many modalities used for the intraprocedural assessment of MS with no one modality considered to be the benchmark. We herein describe a case which illustrates the dynamic nature of clip-leaflet interaction, and review intraprocedural techniques for invasively and noninvasively assessing MS. Copyright © 2016 Elsevier Inc. All rights reserved.

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

PubMed Central

Silverstein, Steven M; Jackson, Mitchell A; Goldberg, Damien F; Muñoz, Mauricio

2014-01-01

Purpose To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0–5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation. Methods The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day –1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ≤5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores). Results The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). Conclusion Bromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures. PMID:24876763

Clinical usefulness of ursodeoxycholic acid for Japanese patients with autoimmune hepatitis

PubMed Central

Torisu, Yuichi; Nakano, Masanori; Takano, Keiko; Nakagawa, Ryo; Saeki, Chisato; Hokari, Atsushi; Ishikawa, Tomohisa; Saruta, Masayuki; Zeniya, Mikio

2017-01-01

AIM To evaluate the therapeutic effects of ursodeoxycholic acid (UDCA) on autoimmune hepatitis (AIH). METHODS A total 136 patients who were diagnosed with AIH were included in our study. All of the patients underwent a liver biopsy, and had at least a probable diagnosis on the basis of either the revised scoring system or the simplified scores. Initial treatment included UDCA monotherapy (Group U, n = 48) and prednisolone (PSL) monotherapy (Group P, n = 88). Group U was further classified into two subgroups according to the effect of UDCA: Patients who had achieved remission induction with UDCA monotherapy and showed no sign of relapse (Subgroup U1, n = 34) and patients who additionally received PSL during follow-up (Subgroup U2, n = 14). We compared the clinical and histological findings between each groups, and investigated factors contributing to the response to UDCA monotherapy. RESULTS In Group U, 34 patients (71%) achieved and maintained remission over 49 (range: 8-90) mo (Subgroup U1) and 14 patients (29%) additionally received PSL (Subgroup U2) during follow-up. Two patients in Subgroup U2 achieved remission induction once but additionally required PSL administration because of relapse (15 and 35 mo after the start of treatment). The remaining 12 patients in Subgroup U2 failed to achieve remission induction during follow-up, and PSL was added during 7 (range: 2-18) mo. Compared with Subgroup U2, Subgroup U1 had significantly lower alanine aminotransferase (ALT) levels at onset (124 IU/L vs 262 IU/L, P = 0.023) and a significantly higher proportion of patients with mild inflammation (A1) on histological examination (70.6% vs 35.7%, P = 0.025). When multivariate analysis was performed to identify factors contributing to the response to UDCA monotherapy, only a serum ALT level of 200 IU/L or lower was found to be associated with a significant difference (P = 0.013). CONCLUSION To prevent adverse events related to corticosteroids, UDCA monotherapy for AIH needs to be considered in patients with a serum ALT level of 200 IU/L or lower. PMID:28105259

What is needed to deliver collaborative care to address comorbidity more effectively for adults with a severe mental illness?

PubMed

Lee, Stuart J; Crowther, Elizabeth; Keating, Charlotte; Kulkarni, Jayashri

2013-04-01

Innovative models of care for people with a severe mental illness have been developed across Australia to more effectively address comorbidity and disability by enhancing the collaboration between clinical and non-clinical services. In particular, this review paper focuses on collaboration that has occurred to address comorbidities affecting the following domains: homelessness; substance addiction; physical ill-health; unemployment; and forensic issues. The identification of relevant collaborative care models was facilitated by carrying out a review of the published peer-reviewed literature and policy or other published reports available on the Internet. Contact was also made with representatives of the mental health branches of each Australian state and territory health department to assist in identifying examples of innovative collaborative care models established within their jurisdiction. A number of nationally implemented and local examples of collaborative care models were identified that have successfully delivered enhanced integration of care between clinical and non-clinical services. Several key principles for effective collaboration were also identified. Governmental and organisational promotion of and incentives for cross-sector collaboration is needed along with education for staff about comorbidity and the capacity of cross-sector agencies to work in collaboration to support shared clients. Enhanced communication has been achieved through mechanisms such as the co-location of staff from different agencies to enhance sharing of expertise and interagency continuity of care, shared treatment plans and client records, and shared case review meetings. Promoting a 'housing first approach' with cross-sector services collaborating to stabilise housing as the basis for sustained clinical engagement has also been successful. Cross-sector collaboration is achievable and can result in significant benefits for mental health consumers and staff of collaborating services. Expanding the availability of collaborative care across Australia is therefore a priority for achieving a more holistic, socially inclusive, and effective mental health care system.

Detailed statistical assessment of the characteristics of the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) threshold rules.

PubMed

Dafni, Urania; Karlis, Dimitris; Pedeli, Xanthi; Bogaerts, Jan; Pentheroudakis, George; Tabernero, Josep; Zielinski, Christoph C; Piccart, Martine J; de Vries, Elisabeth G E; Latino, Nicola Jane; Douillard, Jean-Yves; Cherny, Nathan I

2017-01-01

The European Society for Medical Oncology (ESMO) has developed the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), a tool to assess the magnitude of clinical benefit from new cancer therapies. Grading is guided by a dual rule comparing the relative benefit (RB) and the absolute benefit (AB) achieved by the therapy to prespecified threshold values. The ESMO-MCBS v1.0 dual rule evaluates the RB of an experimental treatment based on the lower limit of the 95%CI (LL95%CI) for the hazard ratio (HR) along with an AB threshold. This dual rule addresses two goals: inclusiveness: not unfairly penalising experimental treatments from trials designed with adequate power targeting clinically meaningful relative benefit; and discernment: penalising trials designed to detect a small inconsequential benefit. Based on 50 000 simulations of plausible trial scenarios, the sensitivity and specificity of the LL95%CI rule and the ESMO-MCBS dual rule, the robustness of their characteristics for reasonable power and range of targeted and true HRs, are examined. The per cent acceptance of maximal preliminary grade is compared with other dual rules based on point estimate (PE) thresholds for RB. For particularly small or particularly large studies, the observed benefit needs to be relatively big for the ESMO-MCBS dual rule to be satisfied and the maximal grade awarded. Compared with approaches that evaluate RB using the PE thresholds, simulations demonstrate that the MCBS approach better exhibits the desired behaviour achieving the goals of both inclusiveness and discernment. RB assessment using the LL95%CI for HR rather than a PE threshold has two advantages: it diminishes the probability of excluding big benefit positive studies from achieving due credit and, when combined with the AB assessment, it increases the probability of downgrading a trial with a statistically significant but clinically insignificant observed benefit.

Detailed statistical assessment of the characteristics of the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) threshold rules

PubMed Central

Dafni, Urania; Karlis, Dimitris; Pedeli, Xanthi; Bogaerts, Jan; Pentheroudakis, George; Tabernero, Josep; Zielinski, Christoph C; Piccart, Martine J; de Vries, Elisabeth G E; Latino, Nicola Jane; Douillard, Jean-Yves; Cherny, Nathan I

2017-01-01

Background The European Society for Medical Oncology (ESMO) has developed the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), a tool to assess the magnitude of clinical benefit from new cancer therapies. Grading is guided by a dual rule comparing the relative benefit (RB) and the absolute benefit (AB) achieved by the therapy to prespecified threshold values. The ESMO-MCBS v1.0 dual rule evaluates the RB of an experimental treatment based on the lower limit of the 95%CI (LL95%CI) for the hazard ratio (HR) along with an AB threshold. This dual rule addresses two goals: inclusiveness: not unfairly penalising experimental treatments from trials designed with adequate power targeting clinically meaningful relative benefit; and discernment: penalising trials designed to detect a small inconsequential benefit. Methods Based on 50 000 simulations of plausible trial scenarios, the sensitivity and specificity of the LL95%CI rule and the ESMO-MCBS dual rule, the robustness of their characteristics for reasonable power and range of targeted and true HRs, are examined. The per cent acceptance of maximal preliminary grade is compared with other dual rules based on point estimate (PE) thresholds for RB. Results For particularly small or particularly large studies, the observed benefit needs to be relatively big for the ESMO-MCBS dual rule to be satisfied and the maximal grade awarded. Compared with approaches that evaluate RB using the PE thresholds, simulations demonstrate that the MCBS approach better exhibits the desired behaviour achieving the goals of both inclusiveness and discernment. Conclusions RB assessment using the LL95%CI for HR rather than a PE threshold has two advantages: it diminishes the probability of excluding big benefit positive studies from achieving due credit and, when combined with the AB assessment, it increases the probability of downgrading a trial with a statistically significant but clinically insignificant observed benefit. PMID:29067214

TU-C-12A-09: Modeling Pathologic Response of Locally Advanced Esophageal Cancer to Chemo-Radiotherapy Using Quantitative PET/CT Features, Clinical Parameters and Demographics

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

Zhang, H; Chen, W; Kligerman, S

2014-06-15

Purpose: To develop predictive models using quantitative PET/CT features for the evaluation of tumor response to neoadjuvant chemo-radiotherapy (CRT) in patients with locally advanced esophageal cancer. Methods: This study included 20 patients who underwent tri-modality therapy (CRT + surgery) and had {sup 18}F-FDG PET/CT scans before initiation of CRT and 4-6 weeks after completion of CRT but prior to surgery. Four groups of tumor features were examined: (1) conventional PET/CT response measures (SUVmax, tumor diameter, etc.); (2) clinical parameters (TNM stage, histology, etc.) and demographics; (3) spatial-temporal PET features, which characterize tumor SUV intensity distribution, spatial patterns, geometry, and associatedmore » changes resulting from CRT; and (4) all features combined. An optimal feature set was identified with recursive feature selection and cross-validations. Support vector machine (SVM) and logistic regression (LR) models were constructed for prediction of pathologic tumor response to CRT, using cross-validations to avoid model over-fitting. Prediction accuracy was assessed via area under the receiver operating characteristic curve (AUC), and precision was evaluated via confidence intervals (CIs) of AUC. Results: When applied to the 4 groups of tumor features, the LR model achieved AUCs (95% CI) of 0.57 (0.10), 0.73 (0.07), 0.90 (0.06), and 0.90 (0.06). The SVM model achieved AUCs (95% CI) of 0.56 (0.07), 0.60 (0.06), 0.94 (0.02), and 1.00 (no misclassifications). Using spatial-temporal PET features combined with conventional PET/CT measures and clinical parameters, the SVM model achieved very high accuracy (AUC 1.00) and precision (no misclassifications), significantly better than using conventional PET/CT measures or clinical parameters and demographics alone. For groups with a large number of tumor features (groups 3 and 4), the SVM model achieved significantly higher accuracy than the LR model. Conclusion: The SVM model using all features including quantitative PET/CT features accurately and precisely predicted pathologic tumor response to CRT in esophageal cancer. This work was supported in part by National Cancer Institute Grant R21 CA131979 and R01 CA172638. Shan Tan was supported in part by the National Natural Science Foundation of China 60971112 and 61375018, and by Fundamental Research Funds for the Central Universities 2012QN086.« less

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.

Ex vivo water exchange performance and short-term clinical feasibility assessment of newly developed heat and moisture exchangers for pulmonary rehabilitation after total laryngectomy.

PubMed

van den Boer, Cindy; Muller, Sara H; Vincent, Andrew D; Züchner, Klaus; van den Brekel, Michiel W M; Hilgers, Frans J M

2014-02-01

Laryngectomized patients suffer from respiratory complaints due to insufficient warming and humidification of inspired air in the upper respiratory tract. Improvement of pulmonary humidification with significant reduction of pulmonary complaints is achieved by the application of a heat and moisture exchanger (HME) over the tracheostoma. The aim of this study was to determine whether the new Provox HMEs (XM-HME and XF-HME) have a better water exchange performance than their predecessors (R-HME and L-HME, respectively; Atos Medical, Hörby, Sweden). The other aim was to assess the short-term clinical feasibility of these HMEs. The XM-HME and XF-HME were weighed at the end of inspiration and at the end of expiration at different breathing volumes produced by a healthy volunteer. The associations between weight changes, breathing volume and absolute humidity were determined using both linear and non-linear mixed effects models. Study-specific questionnaires and tally sheets were used in the clinical feasibility study. The weight change of the XM-HME is 3.6 mg, this is significantly higher than that of the R-HME (2.0 mg). The weight change of the XF-HME (2.0 mg) was not significantly higher than that of the L-HME (1.8 mg). The absolute humidity values of both XM- and XF-HME were significantly higher than that of their predecessors. The clinical feasibility study did not reveal any practical problems over the course of 3 weeks. The XM-HME has a significantly better water exchange performance than its predecessor (R-HME). Both newly designed HMEs did succeed in the clinical feasibility study.

Exploration of contextual factors in a successful quality improvement collaborative in English ambulance services: cross-sectional survey.

PubMed

Phung, Viet-Hai; Essam, Nadya; Asghar, Zahid; Spaight, Anne; Siriwardena, Aloysius N

2016-02-01

Clinical leadership and organizational culture are important contextual factors for quality improvement (QI) but the relationship between these and with organizational change is complex and poorly understood. We aimed to explore the relationship between clinical leadership, culture of innovation and clinical engagement in QI within a national ambulance QI Collaborative (QIC). We used a self-administered online questionnaire survey sent to front-line clinicians in all 12 English ambulance services. We conducted a cross-sectional analysis of quantitative data and qualitative analysis of free-text responses. There were 2743 (12% of 22 117) responses from 11 of the 12 participating ambulance services. In the 3% of responders that were directly involved with the QIC, leadership behaviour was significantly higher than for those not directly involved. QIC involvement made no significant difference to responders' perceptions of the culture of innovation in their organization, which was generally considered poor. Although uptake of QI methods was low overall, QIC members were significantly more likely to use QI methods, which were also significantly associated with leadership behaviour. Despite a limited organizational culture of innovation, clinical leadership and use of QI methods in ambulance services generally, the QIC achieved its aims to significantly improve pre-hospital care for acute myocardial infarction and stroke. We postulate that this was mediated through an improvement subculture, linked to the QIC, which facilitated large-scale improvement by stimulating leadership and QI methods. Further research is needed to understand success factors for QI in complex health care environments. © 2016 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

Concordance between actual and pharmacogenetic predicted desvenlafaxine dose needed to achieve remission in major depressive disorder: a 10-week open-label study

PubMed Central

Müller, Daniel J.; Ng, Chee H.; Byron, Keith; Berk, Michael; Singh, Ajeet B.

2017-01-01

Background Pharmacogenetic-based dosing support tools have been developed to personalize antidepressant-prescribing practice. However, the clinical validity of these tools has not been adequately tested, particularly for specific antidepressants. Objective To examine the concordance between the actual dose and a polygene pharmacogenetic predicted dose of desvenlafaxine needed to achieve symptom remission. Materials and methods A 10-week, open-label, prospective trial of desvenlafaxine among Caucasian adults with major depressive disorder (n=119) was conducted. Dose was clinically adjusted and at the completion of the trial, the clinical dose needed to achieve remission was compared with the predicted dose needed to achieve remission. Results Among remitters (n=95), there was a strong concordance (Kendall’s τ-b=0.84, P=0.0001; Cohen’s κ=0.82, P=0.0001) between the actual and the predicted dose need to achieve symptom remission, showing high sensitivity (≥85%), specificity (≥86%), and accuracy (≥89%) of the tool. Conclusion Findings provide initial evidence for the clinical validity of a polygene pharmacogenetic-based tool for desvenlafaxine dosing. PMID:27779571

Concordance between actual and pharmacogenetic predicted desvenlafaxine dose needed to achieve remission in major depressive disorder: a 10-week open-label study.

PubMed

Bousman, Chad A; Müller, Daniel J; Ng, Chee H; Byron, Keith; Berk, Michael; Singh, Ajeet B

2017-01-01

Pharmacogenetic-based dosing support tools have been developed to personalize antidepressant-prescribing practice. However, the clinical validity of these tools has not been adequately tested, particularly for specific antidepressants. To examine the concordance between the actual dose and a polygene pharmacogenetic predicted dose of desvenlafaxine needed to achieve symptom remission. A 10-week, open-label, prospective trial of desvenlafaxine among Caucasian adults with major depressive disorder (n=119) was conducted. Dose was clinically adjusted and at the completion of the trial, the clinical dose needed to achieve remission was compared with the predicted dose needed to achieve remission. Among remitters (n=95), there was a strong concordance (Kendall's τ-b=0.84, P=0.0001; Cohen's κ=0.82, P=0.0001) between the actual and the predicted dose need to achieve symptom remission, showing high sensitivity (≥85%), specificity (≥86%), and accuracy (≥89%) of the tool. Findings provide initial evidence for the clinical validity of a polygene pharmacogenetic-based tool for desvenlafaxine dosing.

Predictive value of serum HCG concentrations in pregnancies achieved after single fresh or vitrified-warmed blastocyst transfer.

PubMed

Oron, Galia; Shavit, Tal; Esh-Broder, Efrat; Weon-Young, Son; Tulandi, Togas; Holzer, Hananel

2017-09-01

Possible differences between serum HCG levels in pregnancies achieved after transfer of a single fresh or a vitrified-warmed blastocyst were evaluated. Out of 1130 single blastocyst transfers resulting in positive HCG results, 789 were single fresh blastocyst transfers and 341 single vitrified-warmed blastocyst transfers. The initial serum HCG levels of 869 clinical intrauterine pregnancies were evaluated, 638 after the transfer of a single fresh blastocysts and 231 after the transfer of a single vitrified-warmed blastocysts. The HCG levels from cycles resulting in a clinical intrauterine pregnancy were significantly higher after the transfer of a single vitrified-warmed blastocyst (383 ± 230 IU/l) versus a fresh transfer (334 ± 192 IU/l; P = 0.01). Threshold values for predicting a clinical pregnancy for a fresh blastocyst were 111 IU/l and for a vitrified-warmed blastocyst 137 IU/l. Our study shows that the overall beta-HCG levels are comparable after the transfer of a fresh or vitrified-warmed blastocyst, suggesting that vitrification most probably does not affect the ability of the embryos to produce beta-HCG. This study further shows that when clinicians counsel patients, they should take into account that higher HCG levels are needed after a vitrified-warmed blastocyst transfer to predict a clinical intrauterine pregnancy. Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

[Clinical Simulation and Emotional Learning].

PubMed

Afanador, Adalberto Amaya

2012-01-01

At present, the clinical simulation has been incorporated into medical school curriculum. It is considered that the simulation is useful to develop skills, and as such its diffusion. Within the acquisition of skills, meaningful learning is an essential emotional component for the student and this point is essential to optimize the results of the simulation experience. Narrative description on the subject of simulation and the degree of "emotionality." The taxonomy is described for the types of clinical simulation fidelity and correlates it with the degree of emotionality required to achieve significant and lasting learning by students. It is essential to take into account the student's level of emotion in the learning process through simulation strategy. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

A wearable computing platform for developing cloud-based machine learning models for health monitoring applications.

PubMed

Patel, Shyamal; McGinnis, Ryan S; Silva, Ikaro; DiCristofaro, Steve; Mahadevan, Nikhil; Jortberg, Elise; Franco, Jaime; Martin, Albert; Lust, Joseph; Raj, Milan; McGrane, Bryan; DePetrillo, Paolo; Aranyosi, A J; Ceruolo, Melissa; Pindado, Jesus; Ghaffari, Roozbeh

2016-08-01

Wearable sensors have the potential to enable clinical-grade ambulatory health monitoring outside the clinic. Technological advances have enabled development of devices that can measure vital signs with great precision and significant progress has been made towards extracting clinically meaningful information from these devices in research studies. However, translating measurement accuracies achieved in the controlled settings such as the lab and clinic to unconstrained environments such as the home remains a challenge. In this paper, we present a novel wearable computing platform for unobtrusive collection of labeled datasets and a new paradigm for continuous development, deployment and evaluation of machine learning models to ensure robust model performance as we transition from the lab to home. Using this system, we train activity classification models across two studies and track changes in model performance as we go from constrained to unconstrained settings.

Effectiveness of the Lidcombe Program for early stuttering in Australian community clinics.

PubMed

O'Brian, Sue; Iverach, Lisa; Jones, Mark; Onslow, Mark; Packman, Ann; Menzies, Ross

2013-12-01

This study explored the effectiveness of the Lidcombe Program for early stuttering in community clinics. Participants were 31 speech-language pathologists (SLPs) using the Lidcombe Program in clinics across Australia, and 57 of their young stuttering clients. Percentage of syllables stuttered (%SS) was collected 9 months after beginning treatment along with information about variables likely to influence outcomes. The mean %SS for the 57 children 9 months after starting treatment was 1.7. The most significant predictor of outcome was Lidcombe Program Trainers Consortium (LPTC) training. The children of trained SLPs (n = 19), compared to the children of untrained SLPs, took 76% more sessions to complete stage 1, but achieved 54% lower %SS scores, 9 months after starting treatment. Results suggest that outcomes for the Lidcombe Program in the general community may be comparable to those obtained in clinical trials when SLPs receive formal training and support.

Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2011-12-01

Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

Regenerative photonic therapy: Review

NASA Astrophysics Data System (ADS)

Salansky, Natasha; Salansky, Norman

2012-09-01

After four decades of research of photobiomodulation phenomena in mammals in vitro and in vivo, a solid foundation is created for the use of photobiomodulation in regenerative medicine. Significant accomplishments are achieved in animal models that demonstrate opportunities for photo-regeneration of injured or pathological tissues: skin, muscles and nerves. However, the use of photobiomodulation in clinical studies leads to controversial results while negative or marginal clinical efficacy is reported along with positive findings. A thor ough analysis of requirements to the optical parameters (dosimetry) for high efficacy in photobimodulation led us to the conclusion that there are several misconceptions in the clinical applications of low level laser therapy (LLLT). We present a novel appr oach of regenerative photonic therapy (RPT) for tissue healing and regeneration that overcomes major drawbacks of LLLT. Encouraging clinical results on RPT efficacy are presented. Requirements for RPT approach and vision for its future development for tissue regeneration is discussed.

Volumetric modulated arc therapy: a review of current literature and clinical use in practice

PubMed Central

Teoh, M; Clark, C H; Wood, K; Whitaker, S; Nisbet, A

2011-01-01

Volumetric modulated arc therapy (VMAT) is a novel radiation technique, which can achieve highly conformal dose distributions with improved target volume coverage and sparing of normal tissues compared with conventional radiotherapy techniques. VMAT also has the potential to offer additional advantages, such as reduced treatment delivery time compared with conventional static field intensity modulated radiotherapy (IMRT). The clinical worldwide use of VMAT is increasing significantly. Currently the majority of published data on VMAT are limited to planning and feasibility studies, although there is emerging clinical outcome data in several tumour sites. This article aims to discuss the current use of VMAT techniques in practice and review the available data from planning and clinical outcome studies in various tumour sites including prostate, pelvis (lower gastrointestinal, gynaecological), head and neck, thoracic, central nervous system, breast and other tumour sites. PMID:22011829

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.

Gamma Knife radiosurgery for vestibular schwannoma: clinical results at long-term follow-up in a series of 379 patients.

PubMed

Boari, Nicola; Bailo, Michele; Gagliardi, Filippo; Franzin, Alberto; Gemma, Marco; del Vecchio, Antonella; Bolognesi, Angelo; Picozzi, Piero; Mortini, Pietro

2014-12-01

Since the 1990 s, Gamma Knife radiosurgery (GKRS) has become the first-line treatment option for small- to medium-size vestibular schwannomas (VSs), especially in patients without mass effect-related symptoms and with functional hearing. The aim of this study was to assess the safety and efficacy of GKRS, in terms of tumor control, hearing preservation, and complications, in a series of 379 consecutive patients treated for VS. Of 523 patients treated at the authors' institution for VS between 2001 and 2010, the authors included 379 who underwent GKRS as the primary treatment. These patients were not affected by Type 2 neurofibromatosis and had clinical follow-up of at least 36 months. Clinical follow-up (mean and median 75.7 and 69.5 months, respectively) was performed for all patients, whereas audiometric and quantitative radiological follow-up examinations were obtained for only 153 and 219 patients, respectively. The patients' ages ranged from 23 to 85 years (mean 59 years). The mean tumor volume was 1.94 ± 2.2 cm(3) (median 1.2 cm(3), range 0.013-14.3 cm(3)), and the median margin dose was 13 Gy (range 11-15 Gy). Parameters considered as determinants of the clinical outcome were long-term tumor control, hearing preservation, and complications. A statistical analysis was performed to correlate clinical outcomes with the radiological features of the tumor, dose-planning parameters, and patient characteristics. Control of the tumor with GKRS was achieved in 97.1% of the patients. In 82.7% of the patients, the tumor volume had decreased at the last follow-up, with a mean relative reduction of 34.1%. The rate of complications was very low, with most consisting of a transient worsening of preexisting symptoms. Patients who had vertigo, balance disorders, or facial or trigeminal impairment usually experienced a complete or at least significant symptom relief after treatment. However, no significant improvement was observed in patients previously reporting tinnitus. The overall rate of preservation of functional hearing at the long-term follow-up was 49%; in patients with hearing classified as Gardner-Robertson (GR) Class I, this value was 71% and reached 93% among cases of GR Class I hearing in patients younger than 55 years. Gamma Knife radiosurgery is a safe and effective treatment for VS, achieving tumor control in 97.1% of cases and resulting in a very low morbidity rate. Younger GR Class I patients had a significantly higher probability of retaining functional hearing even at the 10-year follow-up; for this reason, the time between symptom onset, diagnosis, and treatment should be shortened to achieve better outcomes in functional hearing preservation.

LIMS and Clinical Data Management.

PubMed

Chen, Yalan; Lin, Yuxin; Yuan, Xuye; Shen, Bairong

2016-01-01

In order to achieve more accurate disease prevention, diagnosis, and treatment, clinical and genetic data need extensive and systematically associated study. As one way to achieve precision medicine, a laboratory information management system (LIMS) can effectively associate clinical data in a macrocosmic aspect and genomic data in a microcosmic aspect. This chapter summarizes the application of the LIMS in a clinical data management and implementation mode. It also discusses the principles of a LIMS in clinical data management, as well as the opportunities and challenges in the context of medical informatics.

The efficacy of proanthocyanidins and secnidazole in the treatment of chronic periodontitis after scaling and root planing therapy.

PubMed

Li, M; Li, R; Jin, Q; Pang, J; Xu, Z

2017-01-01

The aim of this study is to evaluate the clinical and microbiological effect of the systemic antibiotic therapy of proanthocyanidins and secnidazole on periodontitis. Seventy-five subjects with chronic periodontitis were randomly divided into two treatment groups (secnidazole or proanthocyanidins) and one placebo control group (25 cases each). Plaque index (PI), gingival index (GI), gingival bleeding index (BI), probing pocket depth (PPD), and clinical attachment level (CAL) were carried out at baseline, post-treatment and 3 months after treatment. Microbial analysis was performed at baseline and post-treatment. The results show that the two treatment groups had greater mean reduction in BI, GI, and PPD evaluated at both post-treatment and 3 months after treatment compared to the control group (p less than 0.05), but there were no significant differences in those of PI and CAL (except CAL evaluated at post-treatment, p 0.05). After treatment, culturable bacteria counts significantly decreased. In conclusion, the adjunctive use of proanthocyanidins or secnidazole in combination with scaling and root planing in adults with periodontitis is effective in reducing the pathogenic flora and achieves significantly better clinical results to a certain degree.

Multiplex Cytokine Analysis of Aqueous Humor in Juvenile Idiopathic Arthritis-Associated Anterior Uveitis With or Without Secondary Glaucoma.

PubMed

Bauer, Dirk; Kasper, Maren; Walscheid, Karoline; Koch, Jörg M; Müther, Philipp S; Kirchhof, Bernd; Heiligenhaus, Arnd; Heinz, Carsten

2018-01-01

Patients with juvenile idiopathic arthritis often develop chronic anterior uveitis (JIAU). JIAU patients possess a particularly high risk for developing secondary glaucoma when inflammatory inactivity has been achieved. By using multiplex bead assay analysis, we assessed levels of pro- and anti-inflammatory cytokines, chemokines, or metalloproteinases in the aqueous humor (AH) of patients with clinically inactive JIAU with (JIAUwG) or without secondary glaucoma (JIAUwoG), or from patients with senile cataract as controls. Laser-flare photometry analysis prior to surgery showed no significant differences between JIAUwG or JIAUwoG. Compared with the control group, levels of interleukin-8, matrix metalloproteinase-2, -3, -9, serum amyloid A (SAA), transforming growth factor beta-1, -2, -3 (TGFβ-1, -2, -3), and tumor necrosis factor-alpha in the AH were significantly higher in patients with clinically inactive JIAUwG or JIAUwoG. Samples from JIAwoG patients displayed significantly higher levels of SAA ( P  < 0.0116) than JIAUwG patients. JIAUwG patients showed an increased level of TGFβ-2 in AH samples compared with JIAUwoG ( P  < 0.0009). These molecules may contribute to the clinical development of glaucoma in patients with JIAU.

Anterior Cervical Corpectomy with free vascularized fibular graft versus multilevel discectomy and grafting for Cervical Spondylotic Myelopathy

PubMed Central

Addosooki, Ahmad I; El-deen, Mohamed Alam

2015-01-01

Purpose A retrospective study to compare the radiologic and clinical outcomes of 2 different anterior approaches, multilevel anterior cervical discectomy with fusion (ACDF) using autologus ticortical bone graft versus anterior cervical corpectomy with fusion (ACCF) using free vascularized fibular graft (FVFG) for the management of cervical spondylotic myelopathy(CSM). Methods A total of 15 patients who underwent ACDF or ACCF using FVFG for multilevel CSM were divided into two groups. Group A (n = 7) underwent ACDF and group B (n = 8) ACCF. Clinical outcomes using Japanese Orthopaedic Association (JOA) score, perioperative parameters including operation time and hospital stay, radiological parameters including fusion rate and cervical lordosis, and complications were compared. Results Both group A and group B demonstrated significant increases in JOA scores. Patients who underwent ACDF experienced significantly shorter operation times and hospital stay. Both groups showed significant increases in postoperative cervical lordosis and achieved the same fusion rate (100 %). No major complications were encountered in both groups. Conclusion Both ACDF and ACCF using FVFG provide satisfactory clinical outcomes and fusion rates for multilevel CSM. However, multilevel ACDF is associated with better radiologic parameters, shorter hospital stay and shorter operative times. PMID:26767152

A Comparison of Students' Perceptions of Stress in Parallel Problem-Based and Lecture-Based Curricula.

PubMed

Wardley, C Sonia; Applegate, E Brooks; Almaleki, A Deyab; Van Rhee, James A

2016-03-01

A 6-year longitudinal study was conducted to compare the perceived stress experienced during a 2-year master's physician assistant program by 5 cohorts of students enrolled in either problem-based learning (PBL) or lecture-based learning (LBL) curricular tracks. The association of perceived stress with academic achievement was also assessed. Students rated their stress levels on visual analog scales in relation to family obligations, financial concerns, schoolwork, and relocation and overall on 6 occasions throughout the program. A mixed model analysis of variance examined the students' perceived level of stress by curriculum and over time. Regression analysis further examined school work-related stress after controlling for other stressors and possible lag effect of stress from the previous time point. Students reported that overall stress increased throughout the didactic year followed by a decline in the clinical year with statistically significant curricular (PBL versus LBL) and time differences. PBL students also reported significantly more stress resulting from school work than LBL students at some time points. Moreover, when the other measured stressors and possible lag effects were controlled, significant differences between PBL and LBL students' perceived stress related to school work persisted at the 8- and 12-month measurement points. Increased stress in both curricula was associated with higher achievement in overall and individual organ system examination scores. Physician assistant programs that embrace a PBL pedagogy to prepare students to think clinically may need to provide students with additional support through the didactic curriculum.

Three hundred and eight nanometer excimer light therapy for alopecia universalis that is resistant to other treatments: A clinical study of 11 patients.

PubMed

Arakawa, Yukiyasu; Nomiyama, Tomoko; Katoh, Norito

2016-12-01

Three hundred and eight nanometer excimer light therapy has recently been reported to be effective against patchy alopecia areata (AA) in several clinical studies. However, these studies only included a few patients with severe forms of AA, and all of them exhibited poor outcomes. We further investigated the use of excimer light as a therapeutic option for cases of alopecia universalis (AU) that are resistant to other treatments. Eleven treatment-resistant AU patients were treated with a 308-nm excimer light at 2-week intervals for more than 16 sessions. Four patients achieved good responses and two patients exhibited poor responses. Three patients had Japanese skin type 1 and all of them achieved good responses. The radiation dose was increased until the patients exhibited marked erythema. The patients with Japanese skin type 3 who achieved good responses exhibited strong pigmentation at the irradiated sites. In conclusion, 308-nm excimer light therapy has significant effects on some AU patients who are resistant to other treatments and may be an alternative therapeutic option for AU. During the treatment of AU, high doses of radiation should be administrated until a strong inflammatory skin reaction is seen. © 2016 Japanese Dermatological Association.

Flipped Learning With Simulation in Undergraduate Nursing Education.

PubMed

Kim, HeaRan; Jang, YounKyoung

2017-06-01

Flipped learning has proliferated in various educational environments. This study aimed to verify the effects of flipped learning on the academic achievement, teamwork skills, and satisfaction levels of undergraduate nursing students. For the flipped learning group, simulation-based education via the flipped learning method was provided, whereas traditional, simulation-based education was provided for the control group. After completion of the program, academic achievement, teamwork skills, and satisfaction levels were assessed and analyzed. The flipped learning group received higher scores on academic achievement, teamwork skills, and satisfaction levels than the control group, including the areas of content knowledge and clinical nursing practice competency. In addition, this difference gradually increased between the two groups throughout the trial. The results of this study demonstrated the positive, statistically significant effects of the flipped learning method on simulation-based nursing education. [J Nurs Educ. 2017;56(6):329-336.]. Copyright 2017, SLACK Incorporated.

What variables can influence clinical reasoning?

PubMed Central

Ashoorion, Vahid; Liaghatdar, Mohammad Javad; Adibi, Peyman

2012-01-01

Background: Clinical reasoning is one of the most important competencies that a physician should achieve. Many medical schools and licensing bodies try to predict it based on some general measures such as critical thinking, personality, and emotional intelligence. This study aimed at providing a model to design the relationship between the constructs. Materials and Methods: Sixty-nine medical students participated in this study. A battery test devised that consist four parts: Clinical reasoning measures, personality NEO inventory, Bar-On EQ inventory, and California critical thinking questionnaire. All participants completed the tests. Correlation and multiple regression analysis consumed for data analysis. Results: There is low to moderate correlations between clinical reasoning and other variables. Emotional intelligence is the only variable that contributes clinical reasoning construct (r=0.17-0.34) (R2 chnage = 0.46, P Value = 0.000). Conclusion: Although, clinical reasoning can be considered as a kind of thinking, no significant correlation detected between it and other constructs. Emotional intelligence (and its subscales) is the only variable that can be used for clinical reasoning prediction. PMID:23853636

[Validation and adhesion to GESIDA quality indicators in patients with HIV infection].

PubMed

Riera, Melchor; Esteban, Herminia; Suarez, Ignacio; Palacios, Rosario; Lozano, Fernando; Blanco, Jose R; Valencia, Eulalia; Ocampo, Antonio; Amador, Concha; Frontera, Guillem; vonWichmann-de Miguel, Miguel Angel

2016-01-01

The objective of the study is to validate the relevant GESIDA quality indicators for HIV infection, assessing the reliability, feasibility and adherence to them. The reliability was evaluated using the reproducibility of 6 indicators in peer review, with the second observer being an outsider. The feasibility and measurement of the level of adherence to the 22 indicators was conducted with annual fragmented retrospective collection of information from specific databases or the clinical charts of the nine participating hospitals. Reliability was very high, with interobserver agreement levels higher than 95% in 5 of the 6 indicators. The median time to achieve the indicators ranged between 5 and 600minutes, but could be achieved progressively from specific databases, enabling obtaining them automatically. As regards adherence to the indicators related with the initial evaluation of the patients, instructions and suitability of the guidelines for ART, adherence to ART, follow-up in clinics, and achieve an undetectable HIV by PCR at week 48 of the ART. Indicators of quality related to the prevention of opportunistic infections and control of comorbidities, the standards set were not achieved, and significant heterogeneity was observed between hospitals. The GESIDA quality indicators of HIV infection enabled the relevant indicators to be feasibly and reliably measured, and should be collected in all the units that care for patients with HIV infection. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Future Translational Applications From the Contemporary Genomics Era

PubMed Central

Fox, Caroline S.; Hall, Jennifer L.; Arnett, Donna K.; Ashley, Euan A.; Delles, Christian; Engler, Mary B.; Freeman, Mason W.; Johnson, Julie A.; Lanfear, David E.; Liggett, Stephen B.; Lusis, Aldons J.; Loscalzo, Joseph; MacRae, Calum A.; Musunuru, Kiran; Newby, L. Kristin; O’Donnell, Christopher J.; Rich, Stephen S.; Terzic, Andre

2016-01-01

The field of genetics and genomics has advanced considerably with the achievement of recent milestones encompassing the identification of many loci for cardiovascular disease and variable drug responses. Despite this achievement, a gap exists in the understanding and advancement to meaningful translation that directly affects disease prevention and clinical care. The purpose of this scientific statement is to address the gap between genetic discoveries and their practical application to cardiovascular clinical care. In brief, this scientific statement assesses the current timeline for effective translation of basic discoveries to clinical advances, highlighting past successes. Current discoveries in the area of genetics and genomics are covered next, followed by future expectations, tools, and competencies for achieving the goal of improving clinical care. PMID:25882488

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

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

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

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

Chronic Non-infectious Uveitis in Patients with Juvenile Idiopathic Arthritis.

PubMed

Kolomeyer, Anton M; Tu, Yufei; Miserocchi, Elisabetta; Ranjan, Mangala; Davidow, Amy; Chu, David S

2016-08-01

To describe clinical findings and analyze treatment evolution of chronic, non-infectious uveitis in patients with juvenile idiopathic arthritis (JIA). A total of 82 patients (147 eyes) with JIA-related uveitis treated for ≥2 months were included (78% females; 79% bilateral uveitis; 74% anterior uveitis). Outcome measures were visual acuity (VA), inflammation control, side-effects, and surgical procedures. Mean ± SD age at diagnosis was 4.9 ± 3.8 years; mean ± SD follow-up time was 8.7 ± 7.8 years. Mean VA did not significantly change throughout the study. Three (2%) eyes resulted in no light perception (NLP) vision. Thirty (37%) patients underwent 69 procedures. In total, 41 (50%) patients achieved inflammation control. TNF-α inhibitors were significantly associated with inflammation control. Seven (8.5%) patients stopped treatment due to side-effects. JIA is a cause of significant ocular morbidity. TNF-α inhibitor use was associated with inflammation control. Prospective, randomized, double blind clinical trials in this regard are warranted.

Making an IMPAKT; Improving care of Chronic Kidney Disease patients in the community through collaborative working and utilizing Information Technology.

PubMed

Xu, Gang; Major, Rupert; Shepherd, David; Brunskill, Nigel

2017-01-01

Chronic kidney disease (CKD) is a serious long-term condition, which if left untreated causes significant cardiovascular sequele. It is well recognized management of modifiable risk factors, such as blood pressure (BP), can lead to improved long-term outcomes. A novel information technology (IT) solution presents a possible solution to help clinicians in the community identify and manage at risk patients more efficiently. The IMproving Patient care and Awareness of Kidney disease progression Together (IMPAKT) IT tool was used to identify patients with CKD and uncontrolled hypertension in the community. A CKD nurse utilized the tool at primary care practices to identify patients who warranted potential intervention and disseminated this information to clinical staff. Blood pressure management targets and incidence of coded CKD were used to evaluate the project. Altogether 48 practices participated in an 18 month project from April 2014, and data from 20 practices, with a total adult population of 121,362, was available for analysis. Two full consecutive QI (Quality Improvement) audit cycles were completed. There was an increase in the mean recorded prevalence of coded CKD patients over the course of the project. Similarly, there was an increase in the percentage of patients with BP been recorded and importantly there was an accompanying significant increase in CKD patients achieving BP targets. At the end of the project an additional 345 individuals with CKD achieved better blood pressure control. This could potentially prevent 9 cardiovascular events in the CKD group, translating to a cost saving of £320,000 for the 20 practices involved. The most significant change in clinical markers occurred during cycle 1 of the audit, the improvement was maintained throughout cycle 2 of the audit. Our results show the real-life clinical impact of a relatively simple and easy to implement QI project, to help improve outcomes in patients with CKD. This was achieved through more efficient working by targeting of high-risk groups, and improved communication between primary/secondary care. The project could be adapted for other chronic disease conditions. Despite the recorded improvements in blood pressure management, a large proportion of high-risk patients remained above ideal blood pressure, additional interventions in this area need to be explored. Through collaborative and multi-professional working and utilizing IT resources, we have shown it is possible to deliver measurable and sustainable improvements in blood pressure control for patients with CKD in a real life clinical setting.

Nursing students' assessment of the learning environment in different clinical settings.

PubMed

Bisholt, Birgitta; Ohlsson, Ulla; Engström, Agneta Kullén; Johansson, Annelie Sundler; Gustafsson, Margareta

2014-05-01

Nursing students perform their clinical practice in different types of clinical settings. The clinical learning environment is important for students to be able to achieve desired learning outcomes. Knowledge is lacking about the learning environment in different clinical settings. The aim was to compare the learning environment in different clinical settings from the perspective of the nursing students. A cross-sectional study with comparative design was conducted. Data was collected from 185 nursing students at three universities by means of a questionnaire involving the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) evaluation scale. An open-ended question was added in order to ascertain reasons for dissatisfaction with the clinical placement. The nursing students' satisfaction with the placement did not differ between clinical settings. However, those with clinical placement in hospital departments agreed more strongly that sufficient meaningful learning situations occurred and that learning situations were multi-dimensional. Some students reported that the character of the clinical setting made it difficult to achieve the learning objectives. In the planning of the clinical placement, attention must be paid to whether the setting offers the student a meaningful learning situation where the appropriate learning outcome may be achieved. Copyright © 2013 Elsevier Ltd. All rights reserved.

A Telephone-based Physiotherapy Intervention for Patients with Osteoarthritis of the Knee

PubMed Central

Odole, Adesola C.; Ojo, Oluwatobi D.

2013-01-01

This study assessed the effects of a 6-week telephone based intervention on the pain intensity and physical function of patients with knee osteoarthritis (OA), and compared the results to physiotherapy conducted in the clinic. Fifty randomly selected patients with knee OA were assigned to one of two treatment groups: a clinic group (CG) and a tele-physiotherapy group (TG). The CG received thrice-weekly physiotherapist administered osteoarthritis-specific exercises in the clinic for six weeks. The TG received structured telephone calls thrice-weekly at home, to monitor self-administered osteoarthritis-specific exercises. Participants’ pain intensity and physical function were assessed at baseline, two, four, and six weeks, in the clinic environment. Within group comparison showed significant improvements across baseline, and at weeks two, four, and six for both TG and CG’s pain intensity and physical function. Between-group comparison of CG and TG’s pain intensity and physical function at baseline and weeks two, four, and six showed no significant differences. This study demonstrated that a six-week course of structured telephone calls thrice-weekly to patients at their home, to monitor self-administered osteoarthritis-specific exercises for patients with knee OA (i.e., tele-physiotherapy) achieved comparable results to physiotherapy conducted in the clinic. PMID:25945214

Assessment of Female Participation in an Employee 20-Week Walking Incentive Program at Marshfield Clinic, a Large Multispecialty Group Practice

PubMed Central

Chyou, Po-Huang; Scheuer, David; Linneman, James G.

2006-01-01

Objective: We evaluated the short-term effect of a worksite-based walking incentive program to promote physical activity and well-being in employees of a private healthcare clinic. Design: A prospective, observational follow-up study. Setting: The study was conducted at Marshfield Clinic, a large private multispecialty group practice healthcare institution in Marshfield,Wisconsin, USA. Patients: Subjects for this study were Marshfield Clinic physicians and staff. Methods: From March 31, 2005 to August 20, 2005, physical activity level, body mass index (BMI) and other well-being characteristics were observed pre- and post-program among 191 female participants from the Marshfield Clinic. A brief Web site-accessible, self-reported survey assessed the effectiveness of the exercise program. Results: Our data show a statistically significant (p <0.0001) increase in participants’ physical activity level, while a significant (p = 0.021) decrease in mean BMI was observed. However, there was no evidence of our incentive program reducing participants’ blood pressure. Conclusion: Preliminary findings of our study suggest that the goal of worksite programs designed to support employees in their efforts to improve or maintain their level of wellness is potentially achievable. Continuing research is needed to further assess whether persistent health benefits can be induced by worksite wellness programs. PMID:17210975

Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review.

PubMed

Zhang, Jiaxing; Liang, Yi; Ai, Yuan; Xie, Juan; Li, Youping; Zheng, Wenyi

2017-10-01

We conducted a systematic review to assess the efficacy and safety of Thrombopoietin-receptor agonists (TPOras) for pediatric immune thrombocytopenia (ITP). We searched PubMed, Embase and Cochrane Library from their earliest records to January 2017. Randomized controlled trials (RCTs) were included. Primary outcomes were durable response and clinically significant bleeding. Secondary outcomes were overall response, overall bleeding events, the use of rescue medication and adverse events (AEs). Five randomized RCTs (261participants) were included. Compared with placebo group, the proportion of patients achieving durable platelet response was significantly higher in Eltrombopag (P = 0.0004) or Romiplostim (P = 0.002) group, so was the overall response in Eltrombopag [RR = 2.64, 95% CI (1.58, 4.44)] or Romiplostim [RR = 5.05, 95% CI (2.21, 11.53)] group. Both clinically significant bleeding (P = 0.04) and total bleeding (P = 0.01) in Eltrombopag group were significantly less frequent than those in placebo group, while no significant difference between Romiplostim and placebo group. The proportion of patients receiving rescue medication, the incidence of overall AEs and serious AEs between TPO-receptor agonists and placebo group were not significantly different. TPOras might improve both durable and overall platelet response in pediatric ITP, compared with placebo.

Using Technology, Clinical Workflow Redesign, and Team Solutions to Achieve the Patient Centered Medical Home

DTIC Science & Technology

2011-01-01

The Quadruple Aim: Working Together, Achieving Success 2011 Military Health System Conference TMA and Services Using Technology, Clinical Workflow...Redesign, and Team Solutions to Achieve the Patient Centered Medical Home LTC Nicole Kerkenbush, MHA, MN Army Medical Department, Office of the...Surgeon General Chief Medical Information Officer 1 Military Health System Conference Report Documentation Page Form ApprovedOMB No. 0704-0188 Public

Molecular imaging in drug development: Update and challenges for radiolabeled antibodies and nanotechnology.

PubMed

Colombo, Ilaria; Overchuk, Marta; Chen, Juan; Reilly, Raymond M; Zheng, Gang; Lheureux, Stephanie

2017-11-01

Despite the significant advancement achieved in understanding the molecular mechanisms responsible for cancer transformation and aberrant proliferation, leading to novel targeted cancer therapies, significant effort is still needed to "personalize" cancer treatment. Molecular imaging is an emerging field that has shown the ability to characterize in vivo the molecular pathways present at the cancer cell level, enabling diagnosis and personalized treatment of malignancies. These technologies, particularly SPECT and PET also permit the development of novel radiotheranostic probes, which provide capabilities for diagnosis and treatment with the same agent. The small therapeutic index of most anticancer agents is a limitation in the drug development process. Incorporation of molecular imaging in clinical research may help in overcoming this limitation and favouring selection of patient populations most likely to achieve benefit from targeted therapy. This review will focus on two of the most advanced theranostic approaches with promising potential for application in the clinic: 1) therapeutic monoclonal antibodies which may be linked to a radionuclide for SPECT or PET imaging to guide cancer diagnosis, staging, molecular characterization, and assessment of the response to treatment and 2) multifunctional nanotechnology that allows image guided drug delivery through encapsulation of multiple therapeutic, targeting and imaging agents into a single nanoparticle. Porphysome, a liposome-like nanoparticle, is an example of a novel and promising application of nanotechnology for cancer diagnosis and treatment. These technologies have proven to be effective in preclinical models, warranting further clinical investigation to advance their application for the benefit of cancer patients. Copyright © 2017 Elsevier Inc. All rights reserved.

My Therapist is a Student? The Impact of Therapist Experience and Client Severity on Cognitive Behavioural Therapy Outcomes for People with Anxiety Disorders.

PubMed

Mason, Liam; Grey, Nick; Veale, David

2016-03-01

Allocation of trainee therapist cases is often performed based on intuition and clinical circumstances, with lack of empirical evidence on the role of severity of presenting problem. This has the potential to be anxiety-provoking for supervisors, trainees and service users themselves. To determine how therapist experience interacts with symptom severity in predicting client outcomes. An intention-to-treat analysis of annual outcome data for primary and secondary care clients seen by a specialist anxiety disorders service. 196 clients were stratified into mild, moderate and baseline severe symptoms of anxiety (GAD-7) and depression (PHQ-9). We measured percentage change on these measures, as well as number of sessions and therapy dropout. We also examined rates of reliable and clinically significant change on disorder-specific measures. We hypothesized that qualified therapists would achieve better outcomes than trainees, particularly for severe presentations. Overall, outcomes were comparable between trainee and qualified therapists on all measures, and trainees additionally utilized fewer therapy sessions. There was however an interaction between anxiety severity (GAD-7) and therapist group, such that severely anxious clients achieved greater symptom improvement with qualified as compared to trainee therapists. Further, for trainee but not qualified therapists, baseline anxiety was negatively associated with rate of reliable and clinically significant change on disorder-specific measures. These findings indicate generally favourable outcomes for trainee therapists delivering manualized treatments for anxiety disorders. They additionally suggest that trainee therapists may benefit from additional support when working with clients that present with severe anxiety.

New surgical approach for root coverage of localized gingival recession with acellular dermal matrix: a 12-month comparative clinical study.

PubMed

Barros, Raquel R M; Novaes, Arthur B; Grisi, Márcio F M; Souza, Sérgio L S; Taba, Mário; Palioto, Daniela B

2005-01-01

Acellular dermal matrix graft (ADMG) has been used as an advantageous substitute for autogenous subepithelial connective tissue graft (SCTG). However, the surgical techniques used were primarily developed for the SCTG, and they may not be adequate for ADMG since it has a different healing process than SCTG owing to its different vascular and cellular structures. This study compared the 1-year clinical outcome of a new surgical approach with the outcome of a conventional procedure for the treatment of localized gingival recessions, both performed using the ADMG. The clinical parameters-probing depth, relative clinical attachment level, gingival recession (GR), and width of keratinized tissue-of 32 bilateral Miller Class I or II gingival recessions were assessed at baseline and 12 months postoperatively. Significant clinical changes for both surgical techniques were achieved after this period, including GR reduction from 3.4 mm presurgery to 1.2 mm at 1 year for the conventional technique and from 3.9 mm presurgery to 0.7 mm at 1 year for the new technique. The percentage of root coverage was 62.3% and 82.5% for the conventional and new techniques, respectively. Comparisons between the groups after this period by Mann-Whitney rank sum test revealed statistically significant greater reduction of GR favoring the new procedure (p = .000). Based on the results of this study, it can be concluded that a new surgical technique using an ADMG is more suitable for root coverage when compared with the conventional technique. The results revealed a statistically significant improvement in clinical performance with the ADMG approach.

Recent advances in intensity modulated radiotherapy and proton therapy for esophageal cancer.

PubMed

Xi, Mian; Lin, Steven H

2017-07-01

Radiotherapy is an important component of the standard of care for esophageal cancer. In the past decades, significant improvements in the planning and delivery of radiation techniques have led to better dose conformity to the target volume and improved normal tissue sparing. Areas covered: This review focuses on the advances in radiotherapy techniques and summarizes the availably dosimetric and clinical outcomes of intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy, proton therapy, and four-dimensional radiotherapy for esophageal cancer, and discusses the challenges and future development of proton therapy. Expert commentary: Although three-dimensional conformal radiotherapy is the standard radiotherapy technique in esophageal cancer, the retrospectively comparative studies strongly suggest that the dosimetric advantage of IMRT over three-dimensional conformal radiotherapy can translate into improved clinical outcomes, despite the lack of prospective randomized evidence. As a novel form of conventional IMRT technique, volumetric modulated arc therapy can produce equivalent or superior dosimetric quality with significantly higher treatment efficiency in esophageal cancer. Compared with photon therapy, proton therapy has the potential to achieve further clinical improvement due to their physical properties; however, prospective clinical data, long-term results, and cost-effectiveness are needed.

Randomized clinical trials as reflexive-interpretative process in patients with rheumatoid arthritis: a qualitative study.

PubMed

de Jorge, Mercedes; Parra, Sonia; de la Torre-Aboki, Jenny; Herrero-Beaumont, Gabriel

2015-08-01

Patients in randomized clinical trials have to adapt themselves to a restricted language to capture the necessary information to determine the safety and efficacy of a new treatment. The aim of this study was to explore the experience of patients with rheumatoid arthritis after completing their participation in a biologic therapy randomized clinical trial for a period of 3 years. A qualitative approach was used. The information was collected using 15 semi-structured interviews of patients with rheumatoid arthritis. Data collection was guided by the emergent analysis until no more relevant variations in the categories were found. The data were analysed using the grounded theory method. The objective of the patients when entering the study was to improve their quality of life by initiating the treatment. However, the experience changed the significance of the illness as they acquired skills and practical knowledge related to the management of their disease. The category "Interactional Empowerment" emerged as core category, as it represented the participative experience in a clinical trial. The process integrates the follow categories: "weight of systematisation", "working together", and the significance of the experience: "the duties". Simultaneously these categories evolved. The clinical trial monitoring activities enabled patients to engage in a reflexive-interpretative mechanism that transformed the emotional and symbolic significance of their disease and improved the empowerment of the patient. A better communicative strategy with the health professionals, the relatives of the patients, and the community was also achieved.

Using Medical Text Extraction, Reasoning and Mapping System (MTERMS) to Process Medication Information in Outpatient Clinical Notes

PubMed Central

Zhou, Li; Plasek, Joseph M; Mahoney, Lisa M; Karipineni, Neelima; Chang, Frank; Yan, Xuemin; Chang, Fenny; Dimaggio, Dana; Goldman, Debora S.; Rocha, Roberto A.

2011-01-01

Clinical information is often coded using different terminologies, and therefore is not interoperable. Our goal is to develop a general natural language processing (NLP) system, called Medical Text Extraction, Reasoning and Mapping System (MTERMS), which encodes clinical text using different terminologies and simultaneously establishes dynamic mappings between them. MTERMS applies a modular, pipeline approach flowing from a preprocessor, semantic tagger, terminology mapper, context analyzer, and parser to structure inputted clinical notes. Evaluators manually reviewed 30 free-text and 10 structured outpatient clinical notes compared to MTERMS output. MTERMS achieved an overall F-measure of 90.6 and 94.0 for free-text and structured notes respectively for medication and temporal information. The local medication terminology had 83.0% coverage compared to RxNorm’s 98.0% coverage for free-text notes. 61.6% of mappings between the terminologies are exact match. Capture of duration was significantly improved (91.7% vs. 52.5%) from systems in the third i2b2 challenge. PMID:22195230

Outcome Measures in Spinal Cord Injury

PubMed Central

Alexander, Marcalee S.; Anderson, Kim; Biering-Sorensen, Fin; Blight, Andrew R.; Brannon, Ruth; Bryce, Thomas; Creasey, Graham; Catz, Amiram; Curt, Armin; Donovan, William; Ditunno, John; Ellaway, Peter; Finnerup, Nanna B.; Graves, Daniel E.; Haynes, Beth Ann; Heinemann, Allen W.; Jackson, Amie B.; Johnston, Mark; Kalpakjian, Claire Z.; Kleitman, Naomi; Krassioukov, Andrei; Krogh, Klaus; Lammertse, Daniel; Magasi, Susan; Mulcahey, MJ; Schurch, Brigitte; Sherwood, Arthur; Steeves, John D.; Stiens, Steven; Tulsky, David S.; van Hedel, Hubertus J.A.; Whiteneck, Gale

2009-01-01

Study Design review by the Spinal Cord Outcomes Partnership Endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. Objectives assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. Methods a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. Results imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain, and psycho-social tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. Conclusion significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial. PMID:19381157

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).

Clinical study on the arthroscopic refreshing treatment of anterior cruciate ligament injury combined with stable medial meniscus ramp injury

PubMed Central

Yang, J.; Guan, K.; Wang, J.Z.

2017-01-01

This study sought to investigate the clinical efficacy of arthroscopic refreshing treatment of anterior cruciate ligament (ACL) injury combined with stable medial meniscus ramp injury. Sixty-eight patients treated between January 2010 and January 2014 were included, and their clinical data were retrospectively analyzed. All patients, after being treated using ACL reconstruction, were divided into 2 groups according to meniscus injury treatment method. The observation group (31 cases) was treated by arthroscopic refreshing, which removed the tissue on both sides of the tear edge using a cutting knife, while the control group (37 cases) was treated using Fast-fix sutures. All patients were followed up for at least 24 months. Surgical duration, postoperative function recovery time, and hospital stay for patients in the observation group were significantly shorter than for those of the control group (P<0.05). Both groups showed significant post-operative improvement for Lysholm scores, IKDC scores, and average knee range of motion at 12 and 24 months post-operation (P<0.05), but no significant differences between groups were observed (P>0.05). Regarding the difference in movement range between the healthy and injured sides, both groups showed significant decrease post-operation (P<0.05). Ultimately, there was no significant difference in the recovery of ramp damage and objective symptoms between the two groups (P>0.05). Arthroscopic refreshing treatment of patients with anterior cruciate ligament injury combined with stable ramp lesion can achieve similar clinical curative effects as the Fast-fix suture, thereby providing a simple alternative for patient treatment worth popularizing. PMID:28574418

Exploration of contextual factors in a successful quality improvement collaborative in English ambulance services: cross‐sectional survey

PubMed Central

Phung, Viet‐Hai; Essam, Nadya; Asghar, Zahid; Spaight, Anne

2015-01-01

Abstract Rationale, aims and objectives Clinical leadership and organizational culture are important contextual factors for quality improvement (QI) but the relationship between these and with organizational change is complex and poorly understood. We aimed to explore the relationship between clinical leadership, culture of innovation and clinical engagement in QI within a national ambulance QI Collaborative (QIC). Methods We used a self‐administered online questionnaire survey sent to front‐line clinicians in all 12 English ambulance services. We conducted a cross‐sectional analysis of quantitative data and qualitative analysis of free‐text responses. Results There were 2743 (12% of 22 117) responses from 11 of the 12 participating ambulance services. In the 3% of responders that were directly involved with the QIC, leadership behaviour was significantly higher than for those not directly involved. QIC involvement made no significant difference to responders' perceptions of the culture of innovation in their organization, which was generally considered poor. Although uptake of QI methods was low overall, QIC members were significantly more likely to use QI methods, which were also significantly associated with leadership behaviour. Conclusions Despite a limited organizational culture of innovation, clinical leadership and use of QI methods in ambulance services generally, the QIC achieved its aims to significantly improve pre‐hospital care for acute myocardial infarction and stroke. We postulate that this was mediated through an improvement subculture, linked to the QIC, which facilitated large‐scale improvement by stimulating leadership and QI methods. Further research is needed to understand success factors for QI in complex health care environments. PMID:26303398

Clinical & financial operations. Partnership for quality.

PubMed

Mackin, Annette

2002-11-01

PPS has brought to the forefront the "patient care vs. dollars" tension that has long existed between the clinical and financial functions. Recognition of the legitimacy of this very natural tension is critical to successful clinical and financial management under PPS. Clinical and financial staff members who recognize the interdependencies of their functions and work collaboratively will likely view themselves as members of one interdisciplinary team. An organization that can achieve this major shift in corporate culture will also achieve its most sought after goals.

Prospective, randomized comparison of 3 different hemoclips for the treatment of acute upper GI hemorrhage in an established experimental setting.

PubMed

Kato, Masayuki; Jung, Yunho; Gromski, Mark A; Chuttani, Ram; Matthes, Kai

2012-01-01

Recently, endoscopic clip application devices have undergone redesign and improvements to optimize their clinical use and effectiveness. Initially designed for the treatment of bleeding nonvariceal lesions, these devices are also increasingly used for the closure of perforations, fistulas, and anastomotic leaks. Several clinical studies, both randomized and nonrandomized, have used endoscopic hemoclips for hemostasis. However, no comparative studies have yet been reported in the literature comparing the latest endoscopic clip devices for usability and effectiveness for hemostasis of acute upper GI hemorrhage. We aimed to compare the usability and efficacy of 3 different types of endoscopic clip application devices in an established experimental setting by using a porcine ex-vivo simulator of upper GI hemorrhage. Randomized, controlled, ex-vivo study. Academic medical center. Spurting vessels were created within ex-vivo porcine stomachs as published in prior studies. The vessels were attached to a pressure transducer to record the pressure of the circulating blood replacement. Before the initiation of bleeding, each vessel was randomized to 1 of 3 endoscopic clipping devices: 2 different commonly used hemoclips deployed through the working channel and 1 novel clip deployed via an over-the-scope applications device. Two investigators treated 45 bleeding sites (15 bleeding sites for each device at various randomized locations in the stomach: fundus, body, and antrum). Usability was measured via the endpoints of procedure time and quantity of clips required to achieve hemostasis. Efficacy was measured via the endpoint of pressure increase (Δp) from baseline to after treatment. All of the 45 hemostasis treatments were carried out successfully. The mean procedure times were significantly different among the hemoclips, with the clip deployed in an over-the-scope fashion requiring significantly less time to attain hemostasis compared with the other 2 clips. For number of clips needed to attain hemostasis, the clip deployed in an over-the-scope fashion was significantly superior to the others. There were also significant differences among the changes in pressure (Δp ± SD) among the different hemoclips tested. Ex-vivo study. In this prospective, randomized ex-vivo study, we observed significant differences in the usability (time to achieve hemostasis and number of clips required) and the efficacy (change in pressure achieved by the hemoclips) among the 3 clips. The clip applied in the over-the-scope fashion was superior to the other 2 tested clips with regard to time to achieve hemostasis and number of clips required. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Preliminary application of hybrid operation in the treatment of carotid artery stenosis in patients with complex ischemic cerebrovascular diseases

PubMed Central

Zhang, Liyong; Xing, Tao; Geng, Fenyang; Du, Lixin; Wang, Jiyue

2014-01-01

Along with the recent development of intraluminal interventional techniques and correlated imaging methods, one-stop hybrid operation has become a new focus in clinical settings. The aim of this study is to discuss the clinical significance of the one-stop hybrid endarterectomy surgery in the treatment of complex ischemic cerebrovascular diseases. In this study, clinical data from 10 patients with complex ischemic cerebrovascular diseases (including multi-vessel severe stenosis of the internal extracranial carotid artery, single vessel series stenosis of the internal extracranial carotid artery, in-stent restenosis, complete occlusion of the common carotid or the internal carotid artery) admitted to Beijing Xuanwu Hospital and Liaocheng Brain Hospital, were retrospectively analyzed. All enrolled subjects underwent three types of hybrid operations. The clinical efficacy of this surgery was subsequently assessed in this clinical trial. The results indicated that no related surgical complications were noted during the perioperative period. Intraoperative and postoperative imaging revealed no signs of vascular stenosis, the blood supply recovered, and clinical symptoms were alleviated. The follow-up lasted for 6 to 12 months. Imaging re-examination showed no evidence of re-stenosis and good blood circulation was present in the recanalized blood vessels. Favorable treatment efficacy was achieved. The intracranial blood supply was significantly improved postoperatively. In conclusion, one-stop hybrid operation plays an important role in treating complex stenosis cerebrovascular diseases. PMID:25197423

Predicting Survival From Large Echocardiography and Electronic Health Record Datasets: Optimization With Machine Learning.

PubMed

Samad, Manar D; Ulloa, Alvaro; Wehner, Gregory J; Jing, Linyuan; Hartzel, Dustin; Good, Christopher W; Williams, Brent A; Haggerty, Christopher M; Fornwalt, Brandon K

2018-06-09

The goal of this study was to use machine learning to more accurately predict survival after echocardiography. Predicting patient outcomes (e.g., survival) following echocardiography is primarily based on ejection fraction (EF) and comorbidities. However, there may be significant predictive information within additional echocardiography-derived measurements combined with clinical electronic health record data. Mortality was studied in 171,510 unselected patients who underwent 331,317 echocardiograms in a large regional health system. We investigated the predictive performance of nonlinear machine learning models compared with that of linear logistic regression models using 3 different inputs: 1) clinical variables, including 90 cardiovascular-relevant International Classification of Diseases, Tenth Revision, codes, and age, sex, height, weight, heart rate, blood pressures, low-density lipoprotein, high-density lipoprotein, and smoking; 2) clinical variables plus physician-reported EF; and 3) clinical variables and EF, plus 57 additional echocardiographic measurements. Missing data were imputed with a multivariate imputation by using a chained equations algorithm (MICE). We compared models versus each other and baseline clinical scoring systems by using a mean area under the curve (AUC) over 10 cross-validation folds and across 10 survival durations (6 to 60 months). Machine learning models achieved significantly higher prediction accuracy (all AUC >0.82) over common clinical risk scores (AUC = 0.61 to 0.79), with the nonlinear random forest models outperforming logistic regression (p < 0.01). The random forest model including all echocardiographic measurements yielded the highest prediction accuracy (p < 0.01 across all models and survival durations). Only 10 variables were needed to achieve 96% of the maximum prediction accuracy, with 6 of these variables being derived from echocardiography. Tricuspid regurgitation velocity was more predictive of survival than LVEF. In a subset of studies with complete data for the top 10 variables, multivariate imputation by chained equations yielded slightly reduced predictive accuracies (difference in AUC of 0.003) compared with the original data. Machine learning can fully utilize large combinations of disparate input variables to predict survival after echocardiography with superior accuracy. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Impact of high-fidelity simulation on the development of clinical judgment and motivation among Lebanese nursing students.

PubMed

Fawaz, Mirna A; Hamdan-Mansour, Ayman M

2016-11-01

High-fidelity simulation (HFS) offers a strategy to facilitate cognitive, affective, and psychomotor outcomes and motivate the new generation of students. The purpose of this study was to examine the impact of using high-fidelity simulation on the development of clinical judgment and motivation among Lebanese nursing students. A post-test, quasi-experimental design was used. Two private universities in Lebanon were targeted to implement the intervention. A convenience sample of 56 nursing students from two private universities in Lebanon were recruited. Data were collected using the Lasater Clinical Judgment Rubric and the Motivated Strategies for Learning questionnaires. Nursing students exhibited significant improvement in clinical judgment and motivation due to exposure to HFS. There was a significant difference post HFS between the intervention group and the control group in clinical judgment intervention (t=5.23, p<0.001) and motivation for academic achievement (t=-6.71, p<0.001). The intervention group had a higher mean score of clinical judgment (29.5, SD=5.4) than the control group (22.1, SD=5.7) and, similarly, students had higher mean scores of motivation (198.6, SD=10.5) in the intervention group than in the control group (161.6, SD=20). The analysis related to differences between the intervention and control groups in motivation and clinical judgment; controlling for previous experience in health care services, the analysis showed no significant difference (Wilk's lambda =0.77, F=1.09, p=0.374). There is a need for nursing educators to implement HFS in nursing curricula, where its integration can bridge the gap between theoretical knowledge and nursing practice and enhance critical thinking and motivation among nursing students. Copyright © 2016 Elsevier Ltd. All rights reserved.

Personalized Symptom Goals and Patient Global Impression on Clinical Changes in Advanced Cancer Patients.

PubMed

Mercadante, Sebastiano; Adile, Claudio; Lanzetta, Gaetano; Mystakidou, Kyriaki; Maltoni, Marco; Soares, Luiz Guilherme; De Santis, Stefano; Ferrera, Patrizia; Valenti, Marco; Rosati, Marta; Rossi, Romina; Cortegiani, Andrea; Masedu, Francesco; Marinangeli, Franco; Aielli, Federica

2018-05-16

The aim of this study was to assess the patients' global impression (PGI) after symptom management, as well as the achievement of personalized symptom goals (PSG). The secondary outcome was to assess related factors. Subjects, Materials, and Methods . Advanced cancer patients admitted to palliative care units rated symptom intensity by using the Edmonton Symptom Assessment Score (ESAS) at admission and then after 1 week. For each symptom, patient-reported PGI and PSG, as well as the rate of PSG response, were evaluated. Eight hundred seventy-six patients were taken into consideration for this study. A mean of 1.71-2.16 points was necessary to perceive a bit better improvement of symptom intensity. Most patients had a PSG of ≤3. A statistically significant number of patients achieved their PSG after starting palliative care. Patients with high intensity of ESAS items at admission achieved a more favorable PGI response. In the multivariate analysis, symptom intensity and PSG were the most frequent factors independently associated to a best PGI, whereas high levels of Karnofsky had a lower odd ratio. PSG and PGI seem to be relevant for patients' assessment and decision-making process, translating in terms of therapeutic intervention. Some factors may be implicated in determining the individual target and clinical response. Personalized symptom goals and global impression of change are relevant for patients' assessment and decision-making process, translating in terms of therapeutic intervention. Some factors may be implicated in determining the individual target and clinical response. © AlphaMed Press 2018.

The effectiveness of holistic diabetic management between Siriraj Continuity of Care clinic and medical out-patient department.

PubMed

Chalermsri, Chalobol; Paisansudhi, Supalerg; Kantachuvesiri, Pitchaporn; Pramyothin, Pornpoj; Washirasaksiri, Chaiwat; Srivanichakorn, Weerachai; Nopmaneejumruslers, Cherdchai; Chouriyagune, Charoen; Pandejpong, Denla; Phisalprapa, Pochamana

2014-03-01

Diabetes mellitus is one of the most common diseases in the Thai population, and it is well known that diabetic complications could be prevented with appropriate management. Despite published guidelines, most Thai patients with diabetes do not achieve treatment goals. Siriraj Continuity of Care clinic (CC clinic) was recently established in order to provide training for medical students and internal medicine residents. It is possible that the training component in the CC clinic may contribute to better overall outcomes in type 2 diabetes mellitus (type 2 DM) patients when compared with usual care at the medical out-patient department (OPD). To compare the effectiveness of diabetic management in type 2 diabetes mellitus patients who attended the CC clinic and the medical OPD. Retrospective chart review was performed in type 2 diabetes mellitus patients who were treated at either clinic at Siriraj Hospital in 2007-2011. Baseline demographics, treatment strategies and outcomes, and participation in an appropriate health maintenance program were assessed in both groups. Seven hundred and fifty seven medical records were reviewed, including 383 patients in the CC clinic group and 374 in the OPD group. Mean HbA1c was significantly lower in the CC clinic group compared with the OPD group (7.3 +/- 0.9% and 7.8 +/- 1.3%, respectively, < 0.001). The number of patients who achieved goal HbA1c of less than 7% in CC clinic group was 123 (32.1%) compared with 91 (24.3%) in the OPD group (p = 0.039). More patients were screened for diabetic complications in the CC clinic group compared with the OPD group, including screening for diabetic neuropathy (57.4% vs. 2.1%, p < 0.001), diabetic retinopathy (56.7% vs. 36.6%, p < 0.001), and diabetic nephropathy (80.9% vs. 36.9%, p < 0.001). Patients in the CC clinic group had a higher rate of age-appropriate cancer screening than those in the OPD group (54.2% vs. 13.3%, p < 0.001 for breast cancer; 24.0% vs. 0.9%, p < 0.001 for cervical cancer; and 23.0% vs. 7.4%, p < 0.001 for colon cancer). Moreover, significantly more patients in the CC clinic group received recommended immunization (influenza, diphtheria tetanus and pneumococcal vaccine) compared with the control group (p < or = 0.001). Diabetic patients treated at the CC clinic had better clinical outcomes and healthcare maintenance compared with those who received usual care at the medical OPD. Continuity of care and integrated training component may have contributed to the improved outcomes.

Imbalanced target prediction with pattern discovery on clinical data repositories.

PubMed

Chan, Tak-Ming; Li, Yuxi; Chiau, Choo-Chiap; Zhu, Jane; Jiang, Jie; Huo, Yong

2017-04-20

Clinical data repositories (CDR) have great potential to improve outcome prediction and risk modeling. However, most clinical studies require careful study design, dedicated data collection efforts, and sophisticated modeling techniques before a hypothesis can be tested. We aim to bridge this gap, so that clinical domain users can perform first-hand prediction on existing repository data without complicated handling, and obtain insightful patterns of imbalanced targets for a formal study before it is conducted. We specifically target for interpretability for domain users where the model can be conveniently explained and applied in clinical practice. We propose an interpretable pattern model which is noise (missing) tolerant for practice data. To address the challenge of imbalanced targets of interest in clinical research, e.g., deaths less than a few percent, the geometric mean of sensitivity and specificity (G-mean) optimization criterion is employed, with which a simple but effective heuristic algorithm is developed. We compared pattern discovery to clinically interpretable methods on two retrospective clinical datasets. They contain 14.9% deaths in 1 year in the thoracic dataset and 9.1% deaths in the cardiac dataset, respectively. In spite of the imbalance challenge shown on other methods, pattern discovery consistently shows competitive cross-validated prediction performance. Compared to logistic regression, Naïve Bayes, and decision tree, pattern discovery achieves statistically significant (p-values < 0.01, Wilcoxon signed rank test) favorable averaged testing G-means and F1-scores (harmonic mean of precision and sensitivity). Without requiring sophisticated technical processing of data and tweaking, the prediction performance of pattern discovery is consistently comparable to the best achievable performance. Pattern discovery has demonstrated to be robust and valuable for target prediction on existing clinical data repositories with imbalance and noise. The prediction results and interpretable patterns can provide insights in an agile and inexpensive way for the potential formal studies.

The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis.

PubMed

Wiland, Piotr; Dudler, Jean; Veale, Douglas; Tahir, Hasan; Pedersen, Ron; Bukowski, Jack; Vlahos, Bonnie; Williams, Theresa; Gaylord, Stefanie; Kotak, Sameer

2016-07-01

An analysis of a clinical trial to assess the effects of treatment reduction and withdrawal on patient-reported outcomes (PRO) in patients with early, moderate to severe rheumatoid arthritis (RA) who achieved 28-joint Disease Activity Score (DAS28) low disease activity (LDA) or remission with etanercept (ETN) plus methotrexate (MTX) therapy. During treatment induction, patients received open-label ETN 50 mg weekly plus MTX for 52 weeks. In the reduced-treatment phase, patients with DAS28-erythrocyte sedimentation rate (ESR) ≤ 3.2 at Week 39 and DAS28-ESR < 2.6 at Week 52 in the open-label phase were randomized to double-blind treatment with ETN 25 mg plus MTX, MTX, or placebo (PBO) for 39 weeks (weeks 0-39). In the third phase, patients who achieved DAS28 remission (DAS28-ESR < 2.6) or LDA (2.6 ≤ DAS28-ESR ≤ 3.2) at Week 39 in the double-blind phase had all treatment withdrawn and were observed for an additional 26 weeks (weeks 39-65). Of the 306 patients enrolled, 193 were randomized in the double-blind phase and 131 participated in the treatment-withdrawal phase. After reduction or withdrawal of ETN 50 mg/MTX, patients reduced to ETN 25 mg/MTX experienced slight, nonsignificant declines in the majority of PRO measures, whereas switching to PBO or MTX alone caused significant declines. Presenteeism and activity impairment scores were significantly better in the ETN reduced-dose group versus MTX monotherapy and PBO at Week 39 (p ≤ 0.05). In patients with early RA who achieved remission while receiving full-dose ETN/MTX, continuing combination therapy at a lower dose did not cause a significant worsening of PRO response, but switching to MTX alone or PBO did. ClinicalTrials.gov identifier: NCT00913458.

Hemostasis and Post-operative Care of Oral Surgical Wounds by Hemcon Dental Dressing in Patients on Oral Anticoagulant Therapy: A Split Mouth Randomized Controlled Clinical Trial.

PubMed

Kumar, K R Ashok; Kumar, Jambukeshwar; Sarvagna, Jagadesh; Gadde, Praveen; Chikkaboriah, Shwetha

2016-09-01

Hemostasis is a fundamental management issue post-operatively in minor oral surgical procedures. To ensure safety and therapeutic efficacy in patients, under oral anti coagulant therapy, is complicated by necessity for frequent determination of prothrombin time or international normalised ratio. The aim of the study was to determine whether early hemostasis achieved by using Hemcon Dental Dressing (HDD) will affect post-operative care and surgical healing outcome in minor oral surgical procedures. A total of 30 patients, aged 18 years to 90 years, except those allergic to seafood, who consented to participate, were enrolled into this study. Patients were required to have two or more surgical sites so that they would have both surgical and control sites. All patients taking Oral Anticoagulation Therapy (OAT) were included for treatment in the study without altering the anticoagulant regimens. Institutional Review Board approval was obtained for the same. The collected data was subjected to statistical analysis using unpaired t-test. All HDD surgically treated sites achieved hemostasis in 1.49 minutes and control wounds in 4.06 minutes (p < 0.001). Post-operative pain at HDD treated sites (1.87,1.27 on 1 st and 3 rd day respectively) was significantly lower than the control sites (4.0,1.87 on 1 st and 3 rd day respectively) p-value (0.001, 0.001 respectively). HDD treated oral surgery wounds achieved statistically significant improved healing both at 1 st and 3 rd post-operative days (p <0.0001). The HDD has been proven to be a clinically effective hemostatic dressing material that significantly shortens bleeding time following minor oral surgical procedures under local anaesthesia, including those patients taking OAT. Patients receiving the HDD had improved surgical wound healing as compared to controls.

Repeat surgery for focal cortical dysplasias in children: indications and outcomes.

PubMed

Sacino, Matthew F; Ho, Cheng-Ying; Whitehead, Matthew T; Kao, Amy; Depositario-Cabacar, Dewi; Myseros, John S; Magge, Suresh N; Keating, Robert F; Gaillard, William D; Oluigbo, Chima O

2017-02-01

OBJECTIVE Focal cortical dysplasia (FCD) is a common cause of medically intractable epilepsy that often may be treated by surgery. Following resection, many patients continue to experience seizures, necessitating a decision for further surgery to achieve the desired seizure outcomes. Few studies exist on the efficacy of reoperation for intractable epilepsy due to FCD in pediatric cohorts, including the definition of prognostic factors correlated with clinical benefit from further resection. METHODS The authors retrospectively analyzed the medical records and MR images of 22 consecutive pediatric patients who underwent repeat FCD resection after unsuccessful first surgery at the Children's National Health System between March 2005 and April 2015. RESULTS Accounting for all reoperations, 13 (59%) of the 22 patients achieved complete seizure freedom and another 5 patients (23%) achieved significant improvement in seizure control. Univariate analysis demonstrated that concordance in electrocorticography (ECoG) and MRI localization (p = 0.005), and completeness of resection (p = 0.0001), were associated with seizure freedom after the first reoperation. Patients with discordant ECoG and MRI findings ultimately benefited from aggressive multilobe lobectomy or hemispherectomy. Repeat lesionectomies utilizing intraoperative MRI (iMRI; n = 9) achieved complete resection and seizure freedom in all cases. CONCLUSIONS Reoperation may be clinically beneficial in patients with intractable epilepsy due to FCD. Patients with concordant intraoperative ECoG and MRI localization may benefit from extended resection of residual dysplasia at the margins of the previous lesional cavity, and iMRI may offer benefits as a quality control mechanism to ensure that a complete resection has been accomplished. Patients with discordant findings may benefit from more aggressive resections at earlier stages to achieve better seizure control and ensure functional plasticity.

[Clinical and biological prognostic factors in relapsed acute myeloid leukemia patients].

PubMed

Yébenes-Ramírez, Manuel; Serrano, Josefina; Martínez-Losada, Carmen; Sánchez-García, Joaquín

2016-09-02

Acute myeloid leukemia (AML) is the most frequent type of acute leukemia in adults. Despite recent advances in the characterization of pathogenesis of AML, the cure rates are under 40%, being leukemia relapse the most common cause of treatment failure. Leukaemia relapse occurs due to clonal evolution or clonal escape. In this study, we aimed to analyze the clinical and biological factors influencing outcomes in patients with AML relapse. We included a total of 75 AML patients who experienced leukaemia relapse after achieving complete remission. We performed complete immunophenotyping and conventional karyotyping in bone marrow aspirates obtained at diagnosis and at leukemia relapse. Overall survival (OS) of the series was 3.7%±2.3, leukaemia progression being the most common cause of death. Patients relapsing before 12 months and those with adverse cytogenetic-molecular risk had statistically significant worse outcomes. A percentage of 52.5 of patients showed phenotypic changes and 50% cytogenetic changes at relapse. We did not find significant clinical factors predicting clonal evolution. The presence of clonal evolution at relapse did not have a significant impact on outcome. Patients with relapsed AML have a dismal prognosis, especially those with early relapse and adverse cytogenetic-molecular risk. Clonal evolution with phenotypic and cytogenetic changes occurred in half of the patients without predictive clinical factors or impact on outcome. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Avoidable Technical and Clinical Denial Write-Off Management in Hospitals, Physician Offices, and Clinics.

PubMed

Terra, Sandra Marlene; Byrne, Amanda

2016-01-01

This article reviews the various types of technical and clinical denials that are usually "written off" and proposes strategies to prevent this loss. For purposes of this writing, avoidable technical and clinical denial write-offs are defined as revenue lost from "first-pass" denials rejections. For example, a procedure that requires an authorization is performed without having had an authorization obtained. After appeals and attempts to recoup the revenue, often unsuccessful, the organization ultimately "writes off" the revenue as not collectable. The question to ask is: Are these claims really not collectable or can actionable steps be taken to conserve these dollars and improve the bottom line? Acute care hospitals, physician offices, and clinics. In today's environment, the need to manage costs is ubiquitous. Cost management is on the priority list of all savvy health care executives, even if margins are healthy, revenue is under pressure, and the magnitude of cost reduction needed is greater than what past efforts have achieved. As hospitals and physician clinics prioritize areas for improvement, reduction in lost revenue-especially avoidable lost revenue-should be at the top of the list. Attentively managing claim denial write-offs will significantly reduce lost revenue. There is significant interface between case management and the revenue cycle. Developing core competencies for reducing clinical and technical denials should be a critical imperative in overall cost management strategy. Case managers are well placed to prevent these unnecessary losses through accurate status determination and clinical documentation review. These clinical professionals can also provide insight into work flow and other processes inherent in the preauthorization process.

Rubber band ligation of haemorrhoids in the out-patient clinic.

PubMed Central

Kumar, N.; Paulvannan, S.; Billings, P. J.

2002-01-01

Rubber band ligation (RBL) is an effective treatment for symptomatic haemorrhoids but carries significant morbidity. We performed a prospective study of 98 consecutive patients treated by RBL in the out-patient clinic. Immediate, intermediate (within 2 weeks) and late (within 2 months) complications were recorded. Immediate complications occurred in 66 (67.3%) patients. Pain was the predominant symptom in 50 patients (51%). Fifteen (15.3%) patients had vasovagal attacks and 1 (1%) had bleeding. Twenty-five patients (25.5%) were unable to perform normal activities on the day of RBL. One patient needed hospital admission for control of pain. Seventy four (75.5%) patients would have RBL if they needed further treatment for haemorrhoids. Symptomatic cure was achieved in 71 patients (72.4%). RBL is an effective treatment but with significant complications. Patients should be adequately warned, especially of pain and vasovagal attacks. PMID:12092868

Hypnosis for childbirth: a retrospective comparative analysis of outcomes in one obstetrician's practice.

PubMed

VandeVusse, Leona; Irland, Jacqueline; Healthcare, Wheaton Franciscan; Berner, Margaret A; Fuller, Shauna; Adams, Debra

2007-10-01

This exploratory, descriptive study, done retrospectively from perinatal medical records, compared childbirth outcomes in one obstetrician's caseload between 50 women who elected antepartal hypnosis preparation (usually a 5-class series) and 51 who did not. The groups were demographically similar. To achieve similar numbers to the hypnosis group, the control group was randomly selected from the women in the caseload who opted not to take hypnosis preparation, based on characteristics of parity and delivery mode. Prenatal hypnosis preparation resulted in significantly less use of sedatives, analgesia, and regional anesthesia during labor and in higher 1-minute neonatal Apgar scores. Other physiologic and outcome measures did not reveal statistical significance, although some trends were of clinical interest. Well-controlled studies are warranted for clinicians to offer hypnosis more frequently as a pain relief option for childbirth. Additional information provided includes pragmatic, clinical, and cost information about incorporating hypnosis into a physician's practice.

From passive tool holders to microsurgeons: safer, smaller, smarter surgical robots.

PubMed

Bergeles, Christos; Yang, Guang-Zhong

2014-05-01

Within only a few decades from its initial introduction, the field of surgical robotics has evolved into a dynamic and rapidly growing research area with increasing clinical uptake worldwide. Initially introduced for stereotaxic neurosurgery, surgical robots are now involved in an increasing number of procedures, demonstrating their practical clinical potential while propelling further advances in surgical innovations. Emerging platforms are also able to perform complex interventions through only a single-entry incision, and navigate through natural anatomical pathways in a tethered or wireless fashion. New devices facilitate superhuman dexterity and enable the performance of surgical steps that are otherwise impossible. They also allow seamless integration of microimaging techniques at the cellular level, significantly expanding the capabilities of surgeons. This paper provides an overview of the significant achievements in surgical robotics and identifies the current trends and future research directions of the field in making surgical robots safer, smaller, and smarter.

[Rehabilitation prognosis of aphasias of various etiologies with reference to clinical, neurolinguistic and computerized tomography findings].

PubMed

Mezger, G; Busch, G

1988-05-01

To obtain further insights into the rehabilitation outlook in different baseline conditions, a comparison was made of data and treatment outcomes in 92 patients having aphasias of different etiology and disease duration. Rating as "improved" was contingent on significant changes in at least 2 subtests of the AAT (Aachener Aphasietest), which is a fairly stringent requirement. This criterion was met by some 35% of the patients overall, independent of their age; the percentage increased to 45% in case of treatment onset during the first year, while in later onset, significant improvement was achieved in 15% only. Aphasic syndromes secondary to hemorrhage, trauma, tumors, or infections, usually are less severe than the predominant classical syndromes, i.e. Global, Broca and Wernicke aphasia, caused by ischemic stroke. CT lesion size did not yield any definite information. Minor improvements below the required significance levels, and, above all, gains in communication performance, i.e. further consolidation, could be achieved by appropriate management even after the crucial initial year, which, however, does not imply any fundamental changes in the rehabilitation prognosis as such.

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs.

PubMed

Tapuria, Archana; Kalra, Dipak; Kobayashi, Shinji

2013-12-01

The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes.

Future translational applications from the contemporary genomics era: a scientific statement from the American Heart Association.

PubMed

Fox, Caroline S; Hall, Jennifer L; Arnett, Donna K; Ashley, Euan A; Delles, Christian; Engler, Mary B; Freeman, Mason W; Johnson, Julie A; Lanfear, David E; Liggett, Stephen B; Lusis, Aldons J; Loscalzo, Joseph; MacRae, Calum A; Musunuru, Kiran; Newby, L Kristin; O'Donnell, Christopher J; Rich, Stephen S; Terzic, Andre

2015-05-12

The field of genetics and genomics has advanced considerably with the achievement of recent milestones encompassing the identification of many loci for cardiovascular disease and variable drug responses. Despite this achievement, a gap exists in the understanding and advancement to meaningful translation that directly affects disease prevention and clinical care. The purpose of this scientific statement is to address the gap between genetic discoveries and their practical application to cardiovascular clinical care. In brief, this scientific statement assesses the current timeline for effective translation of basic discoveries to clinical advances, highlighting past successes. Current discoveries in the area of genetics and genomics are covered next, followed by future expectations, tools, and competencies for achieving the goal of improving clinical care. © 2015 American Heart Association, Inc.

Effect of 25% Sodium Reduction on Sales of a Top-Selling Bread in Remote Indigenous Australian Community Stores: A Controlled Intervention Trial

PubMed Central

McMahon, Emma; Webster, Jacqui; Brimblecombe, Julie

2017-01-01

Reducing sodium in the food supply is key to achieving population salt targets, but maintaining sales is important to ensuring commercial viability and maximising clinical impact. We investigated whether 25% sodium reduction in a top-selling bread affected sales in 26 remote Indigenous community stores. After a 23-week baseline period, 11 control stores received the regular-salt bread (400 mg Na/100 g) and 15 intervention stores received the reduced-salt version (300 mg Na/100 g) for 12-weeks. Sales data were collected to examine difference between groups in change from baseline to follow-up (effect size) in sales (primary outcome) or sodium density, analysed using a mixed model. There was no significant effect on market share (−0.31%; 95% CI −0.68, 0.07; p = 0.11) or weekly dollars ($58; −149, 266; p = 0.58). Sodium density of all purchases was not significantly reduced (−8 mg Na/MJ; −18, 2; p = 0.14), but 25% reduction across all bread could significantly reduce sodium (−12; −23, −1; p = 0.03). We found 25% salt reduction in a top-selling bread did not affect sales in remote Indigenous community stores. If achieved across all breads, estimated salt intake in remote Indigenous Australian communities would be reduced by approximately 15% of the magnitude needed to achieve population salt targets, which could lead to significant health gains at the population-level. PMID:28264485

HRV biofeedback for pediatric irritable bowel syndrome and functional abdominal pain: a clinical replication series.

PubMed

Stern, Mark J; Guiles, Robert A F; Gevirtz, Richard

2014-12-01

Irritable bowel syndrome (IBS) and Functional Abdominal Pain (FAP) are among the most commonly reported Functional Gastrointestinal Disorders. Both have been associated with varying autonomic dysregulation. Heart Rate Variability Biofeedback (HRVB) has recently begun to show efficacy in the treatment of both IBS and FAP. The purpose of this multiple clinical replication series was to analyze the clinical outcomes of utilizing HRVB in a clinical setting. Archival data of twenty-seven consecutive pediatric outpatients diagnosed with IBS or FAP who received HRVB were analyzed. Clinical outcomes were self-report and categorized as full or remission with patient satisfaction, or no improvement. Qualitative reports of patient experiences were also noted. Full remission was achieved by 69.2 % and partial remission was achieved by 30.8 % of IBS patients. Full remission was achieved by 63.6 % and partial remission was achieved by 36.4 % of FAP patients. No patients in either group did not improve to a level of patient satisfaction or >50 %. Patient's commonly reported feeling validated in their discomfort as a result of psychophysiological education. Results suggest that HRVB is a promising intervention for pediatric outpatients with IBS or FAP. Randomized controlled trials are necessary to accurately determine clinical efficacy of HRVB in the treatment of IBS and FAP.

Company Profile: GenesFX Health Pty Ltd.

PubMed

Sheffield, Leslie J; Rogers, Edith

2011-07-01

GenesFX Health (Melbourne, Australia) is providing genetic testing with clinical interpretation to personalize how people take medications. The company's aim is to achieve the best health outcomes for patients by ensuring that the way they metabolize medications is included when doctors prescribe them medication. This would be achieved by introducing pharmacogenomics into medical practice to provide more informed prescribing, reduce side effects and create maximum efficacy of medications. Through the use of GenesFX Health innovative genetic test, DNAdose ® , GenesFX Health is able to analyze the profile of a patient's genetic variation and maps this to the optimum drug and dosage for a specific treatment. The company's focus on the interpretation of genetic test results has led to the development of a Pharmacogenomic Database and Pharmacogenomic Interpretation System, which allows the team to communicate complex genetic test results in a meaningful way to doctors. There is a significant opportunity to expand GenesFX Health current model of delivering pharmacogenomic tests, by partnering with other laboratories around the world, making pharmacogenomics more accessible and clinically useful. Doctors using the service have welcomed the clinical guidance. Patients have felt relieved and empowered by understanding why they have adverse reactions to medications, and which medications and doses are most suited to them.

Induction of puberty with human chorionic gonadotropin and follicle-stimulating hormone in adolescent males with hypogonadotropic hypogonadism.

PubMed

Barrio, R; de Luis, D; Alonso, M; Lamas, A; Moreno, J C

1999-02-01

To evaluate the clinical and hormonal responses of adolescent males with hypogonadotropic hypogonadism (HH) in response to gonadotropin replacement with the use of long-term combined hCG and FSH therapy. Prospective clinical study. Clinical pediatric department providing tertiary care. Seven prepubertal males with isolated HH with a mean (+/-SD) age of 15.44+/-1.97 years and seven prepubertal males with panhypopituitarism-associated HH with a mean (+/-SD) age of 18.1+/-3.24 years were studied. Human chorionic gonadotropin (1,000-1,500 IU IM) and FSH (75-100 IU SC) were administered every alternate day of the week until the total induction of puberty and spermatogenesis was achieved. Serum testosterone levels, testicular volume, penis length, and sperm count were evaluated after the administration of hCG and FSH. All patients achieved normal sexual maturation and normal or nearly normal adult male levels of testosterone. The increase in testicular size was significant in both groups. Positive sperm production was assessed in four of five patients with isolated HH and in three of three patients with panhypopituitarism-associated HH. Long-term combined hCG and FSH therapy is effective in inducing puberty, increasing testicular volume, and stimulating spermatogenesis in adolescent males with isolated HH and panhypopituitarism-associated HH.

Oral Administration and Detection of a Near-Infrared Molecular Imaging Agent in an Orthotopic Mouse Model for Breast Cancer Screening

PubMed Central

2018-01-01

Molecular imaging is advantageous for screening diseases such as breast cancer by providing precise spatial information on disease-associated biomarkers, something neither blood tests nor anatomical imaging can achieve. However, the high cost and risks of ionizing radiation for several molecular imaging modalities have prevented a feasible and scalable approach for screening. Clinical studies have demonstrated the ability to detect breast tumors using nonspecific probes such as indocyanine green, but the lack of molecular information and required intravenous contrast agent does not provide a significant benefit over current noninvasive imaging techniques. Here we demonstrate that negatively charged sulfate groups, commonly used to improve solubility of near-infrared fluorophores, enable sufficient oral absorption and targeting of fluorescent molecular imaging agents for completely noninvasive detection of diseased tissue such as breast cancer. These functional groups improve the pharmacokinetic properties of affinity ligands to achieve targeting efficiencies compatible with clinical imaging devices using safe, nonionizing radiation (near-infrared light). Together, this enables development of a “disease screening pill” capable of oral absorption and systemic availability, target binding, background clearance, and imaging at clinically relevant depths for breast cancer screening. This approach should be adaptable to other molecular targets and diseases for use as a new class of screening agents. PMID:29696981

Comparative study of clinical and radiological outcomes of a zero-profile device concerning reduced postoperative Dysphagia after single level anterior cervical discectomy and fusion.

PubMed

Son, Doo Kyung; Son, Dong Wuk; Kim, Ho Sang; Sung, Soon Ki; Lee, Sang Weon; Song, Geun Sung

2014-08-01

This study analyzed clinical and radiological outcomes of a zero-profile anchored spacer (Zero-P) and conventional cage-plate (CCP) for single level anterior cervical discectomy and fusion (ACDF) to compare the incidence and difference of postoperative dysphagia with both devices. We retrospectively reviewed our experiences of single level ACDF with the CCP and Zero-P. From January 2011 to December 2013, 48 patients who had single level herniated intervertebral disc were operated on using ACDF, with CCP in 27 patients and Zero-P in 21 patients. Patients who received more than double-level ACDF or combined circumferential fusion were excluded. Age, operation time, estimated blood loss (EBL), pre-operative modified Japanese Orthopaedic Association (mJOA) scores, post-operative mJOA scores, achieved mJOA scores and recovery rate of mJOA scores were assessed. Prevertebral soft tissue thickness and postoperative dysphagia were analyzed on the day of surgery, and 2 weeks and 6 months postoperatively. The Zero-P group showed same or favorable clinical and radiological outcomes compared with the CCP group. Postoperative dysphagia was significantly low in the Zero-P group. Application of Zero-P may achieve favorable outcomes and reduce postoperative dysphagia in single level ACDF.

Oral Administration and Detection of a Near-Infrared Molecular Imaging Agent in an Orthotopic Mouse Model for Breast Cancer Screening.

PubMed

Bhatnagar, Sumit; Verma, Kirti Dhingra; Hu, Yongjun; Khera, Eshita; Priluck, Aaron; Smith, David E; Thurber, Greg M

2018-05-07

Molecular imaging is advantageous for screening diseases such as breast cancer by providing precise spatial information on disease-associated biomarkers, something neither blood tests nor anatomical imaging can achieve. However, the high cost and risks of ionizing radiation for several molecular imaging modalities have prevented a feasible and scalable approach for screening. Clinical studies have demonstrated the ability to detect breast tumors using nonspecific probes such as indocyanine green, but the lack of molecular information and required intravenous contrast agent does not provide a significant benefit over current noninvasive imaging techniques. Here we demonstrate that negatively charged sulfate groups, commonly used to improve solubility of near-infrared fluorophores, enable sufficient oral absorption and targeting of fluorescent molecular imaging agents for completely noninvasive detection of diseased tissue such as breast cancer. These functional groups improve the pharmacokinetic properties of affinity ligands to achieve targeting efficiencies compatible with clinical imaging devices using safe, nonionizing radiation (near-infrared light). Together, this enables development of a "disease screening pill" capable of oral absorption and systemic availability, target binding, background clearance, and imaging at clinically relevant depths for breast cancer screening. This approach should be adaptable to other molecular targets and diseases for use as a new class of screening agents.

Patient-focused goal planning process and outcome after spinal cord injury rehabilitation: quantitative and qualitative audit.

PubMed

Byrnes, Michelle; Beilby, Janet; Ray, Patricia; McLennan, Renee; Ker, John; Schug, Stephan

2012-12-01

To evaluate the process and outcome of a multidisciplinary inpatient goal planning rehabilitation programme on physical, social and psychological functioning for patients with spinal cord injury. Clinical audit: quantitative and qualitative analyses. Specialist spinal injury unit, Perth, Australia. Consecutive series of 100 newly injured spinal cord injury inpatients. MAIN MEASURE(S): The Needs Assessment Checklist (NAC), patient-focused goal planning questionnaire and goal planning progress form. The clinical audit of 100 spinal cord injured patients revealed that 547 goal planning meetings were held with 8531 goals stipulated in total. Seventy-five per cent of the goals set at the first goal planning meeting were achieved by the second meeting and the rate of goal achievements at subsequent goal planning meetings dropped to 56%. Based on quantitative analysis of physical, social and psychological functioning, the 100 spinal cord injury patients improved significantly from baseline to discharge. Furthermore, qualitative analysis revealed benefits consistently reported by spinal cord injury patients of the goal planning rehabilitation programme in improvements to their physical, social and psychological adjustment to injury. The findings of this clinical audit underpin the need for patient-focused goal planning rehabilitation programmes which are tailored to the individual's needs and involve a comprehensive multidisciplinary team.

The effect of gender on early and intermediate results of endovascular aneurysm repair.

PubMed

Nordness, Paul J; Carter, Glen; Tonnessen, Britt; Charles Sternbergh, W; Money, Samuel R

2003-11-01

Results of endovascular aneurysm repair (EVAR) may be gender dependent. Between September 1997 and September 2001, 118 AneuRx aortic grafts were placed for aneurysmal disease. During this period, 17 females and 101 males were treated with this device. A prospective database was maintained and supplemented with retrospectively gathered information to evaluate early and mid-term end points. A total of 113 devices were deployed in 118 attempts. Length of procedure was greater for females (3.3 +/- 1.75 vs. 2.3 +/- 0.8 hr, p = 0.05) and they were more likely to have significant arterial dissections (12% vs. 1%, p = 0.05). The mortality rates at 1 month were 12% for females and 0% for males ( p = 0.02); the complication rates at 1 month were 41% for females and 15% for males ( p = 0.02). Although technical success was not significantly different between the sexes, assisted primary technical success (requiring endovascular assistance) and assisted secondary technical success (requiring open surgical assistance) were significantly different (71% vs. 96%, p = 0.003; and 76% vs. 98%, p = 0.004, respectively). Clinical success at 1 month was 59% for females and 84% for males ( p = 0.02). This difference was also significant when assessing 1-month assisted primary clinical success (59% vs. 90%, p = 0.003) and assisted secondary clinical success as well (71% vs. 96%, p = 0.003). Clinical success and assisted primary clinical success were not different at 6- or 12-month intervals, however, assisted secondary clinical successes differed at both time intervals (56% vs. 83%, p = 0.02; and 56% vs. 81%, p = 0.05, respectively). As-yet undetermined factors appear to predispose females to complications and technical difficulties in the short term. Endovascular and open procedures required to achieve ongoing clinical success in the following months appear to favor males to a greater degree than females.

A scalable architecture for incremental specification and maintenance of procedural and declarative clinical decision-support knowledge.

PubMed

Hatsek, Avner; Shahar, Yuval; Taieb-Maimon, Meirav; Shalom, Erez; Klimov, Denis; Lunenfeld, Eitan

2010-01-01

Clinical guidelines have been shown to improve the quality of medical care and to reduce its costs. However, most guidelines exist in a free-text representation and, without automation, are not sufficiently accessible to clinicians at the point of care. A prerequisite for automated guideline application is a machine-comprehensible representation of the guidelines. In this study, we designed and implemented a scalable architecture to support medical experts and knowledge engineers in specifying and maintaining the procedural and declarative aspects of clinical guideline knowledge, resulting in a machine comprehensible representation. The new framework significantly extends our previous work on the Digital electronic Guidelines Library (DeGeL) The current study designed and implemented a graphical framework for specification of declarative and procedural clinical knowledge, Gesher. We performed three different experiments to evaluate the functionality and usability of the major aspects of the new framework: Specification of procedural clinical knowledge, specification of declarative clinical knowledge, and exploration of a given clinical guideline. The subjects included clinicians and knowledge engineers (overall, 27 participants). The evaluations indicated high levels of completeness and correctness of the guideline specification process by both the clinicians and the knowledge engineers, although the best results, in the case of declarative-knowledge specification, were achieved by teams including a clinician and a knowledge engineer. The usability scores were high as well, although the clinicians' assessment was significantly lower than the assessment of the knowledge engineers.

Low intensity laser therapy: the clinical approach

NASA Astrophysics Data System (ADS)

Kahn, Fred

2006-02-01

Recently, there has been significant improvement in the process of research and application of Low Intensity Laser Therapy (LILT). Despite this positive direction, a wide discrepancy between the research component and clinical understanding of the technology remains. In our efforts to achieve better clinical results and more fully comprehend the mechanisms of interaction between light and cells, further studies are required. The clinical results presented in this paper are extrapolated from a wide range of musculoskeletal problems including degenerative osteoarthritis, repetitive motion injuries, sports injuries, etc. The paper includes three separate clinical studies comprising 151, 286 and 576 consecutive patient discharges at our clinic. Each patient studied received a specific course of treatment that was designed for that individual and was modified on a continuing basis as the healing process advanced. On each visit, clinical status correlation with the duration, dosage and other parameters was carried out. The essentials of the treatment consisted of a three stage approach. This involved a photon stream emanating from a number of specified gallium-aluminum-arsenide diodes; stage one, red light array, stage two consisting of an array of infrared diodes and stage three consisting of the application of an infrared laser diode probe. On average, each of these groups required less than 10 treatments per patient and resulted in a significant improvement / cure rate greater than 90% in all conditions treated. This report clearly demonstrates the benefits of LILT, indicating that it should be more widely adapted in all medical therapeutic settings.

Second-Look Arthroscopic Assessment and Clinical Results of Modified Pull-Out Suture for Posterior Root Tear of the Medial Meniscus

PubMed Central

Song, Jae-Gwang

2014-01-01

Purpose To identify the structural integrity of the healing site after arthroscopic repair of a posterior root tear of the medial meniscus by second-look arthroscopy and to determine the clinical relevance of the findings. Materials and Methods From January 2005 to December 2010, 20 consecutive patients underwent arthroscopic modified pull-out suture repair for a posterior root tear of the medial meniscus. Thirteen patients were available for second-look arthroscopic evaluation. The healing status of the medial meniscus was classified as complete healing, lax healing, scar tissue healing, and failed healing. We evaluated the correlation between the clinical symptoms and second-look arthroscopic findings. Clinical evaluation was based on the Lysholm knee scores and Hospital for Special Surgery (HSS) scores. Results There were 4 cases of complete healing, 4 lax healing, 4 scar tissue healing, and 1 failed healing. The healing status of the repaired meniscus appeared to be related to the clinical symptoms. Patients who achieved complete tissue healing had no complaint. The healing status exhibited no relationship with age, mechanical axis, degree of subluxation, and symptom duration. The mean Lysholm score improved from 34.7 preoperatively to 75.6 at follow-up and the mean HSS score also significantly increased from 33.5 to 82.2. Conclusions We achieved 4 complete and 8 partial healing (lax or scar) of the medial meniscus in this retrospective case series of posterior horn meniscus root repairs performed by 1 surgeon. Further research is needed to clarify why all patients showed clinical improvement despite findings of partial healing on second-look arthroscopy. PMID:24944976

Motions and functional performance after supervised physical therapy program versus home-based program after arthroscopic anterior shoulder stabilization: a randomized clinical trial.

PubMed

Ismail, M M; El Shorbagy, K M

2014-01-01

To compare the effects of a standardized supervised physical therapy versus a controlled home-based programs on the rate of shoulder motion and functional recovery after arthroscopic anterior shoulder stabilization. Twenty-seven patients (18-35years) underwent arthroscopic anterior shoulder stabilization. Patients were randomized into two groups. A supervised group (n=14) received a rehabilitation program, 3 sessions/week for 24 weeks and a controlled home treated group (n=13) who followed a home-based program for same period. Range of motion (ROM) of the shoulder was assessed 4 times after each phase of rehabilitation and function was assessed after the 3rd and 4th phase of rehabilitation. Both groups achieved a significant progressive increase in all shoulder motions throughout the study period. Patients in the supervised group achieved 92.6% and 94.2% of the contralateral side in abduction and forward elevation respectively. The controlled home-based group achieved 87.1% and 94.7% of abduction and forward elevation respectively. For external rotation, the percentage ROM achieved was 81.1% for the supervised group and 76.4% for the controlled home-based group. For function assessment, the two groups showed a significant improvement. However, the two groups were not significantly different from each other in all measured variables. A controlled home-based physical therapy program is as effective as a supervised program in increasing shoulder range of motion and function after arthroscopic anterior shoulder stabilization. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

[Attention therapy for children - long-term affects of the ATTENTIONER].

PubMed

Jacobs, Claus; Petermann, Franz

2008-11-01

A high percentage of children are affected by attention deficit disorders. For a large proportion the cardinal symptom is inattention; in particular, deficits in selective attention prevail. The ATTENTIONER offers an effective training method for the treatment of selective attention deficit. In 2007, long-term effects of therapy were already reported by Jacobs and Petermann, who examined children ten weeks after therapy on average. In the current study three measurements were conducted: pre-intervention, post-intervention, and at follow-up ten to 76 months after post-intervention. Significant long-term effects on measures of selective attention were observed. At follow-up the majority of patients achieved average results which were not clinically relevant. For most children stable therapy effects can be achieved with the ATTENTIONER.

Sleep timing is more important than sleep length or quality for medical school performance.

PubMed

Genzel, L; Ahrberg, K; Roselli, C; Niedermaier, S; Steiger, A; Dresler, M; Roenneberg, T

2013-07-01

Overwhelming evidence supports the importance of sleep for memory consolidation. Medical students are often deprived of sufficient sleep due to large amounts of clinical duties and university load, we therefore investigated how study and sleep habits influence university performance. We performed a questionnaire-based study with 31 medical students of the University of Munich (second and third clinical semesters; surgery and internal medicine). The students kept a diary (in 30-min bins) on their daily schedules (times when they studied by themselves, attended classes, slept, worked on their thesis, or worked to earn money). The project design involved three 2-wk periods (A: during the semester; B: directly before the exam period--pre-exam; C: during the subsequent semester break). Besides the diaries, students completed once questionnaires about their sleep quality (Pittsburgh Sleep Quality Index [PSQI]), their chronotype (Munich Chronotype Questionnaire [MCTQ]), and their academic history (previous grades, including the previously achieved preclinical board exam [PBE]). Analysis revealed significant correlations between the actual sleep behavior during the semester (MS(diary); mid-sleep point averaged from the sleep diaries) during the pre-exam period and the achieved grade (p = 0.002) as well as between the grades of the currently taken exam and the PBE (p = 0.002). A regression analysis with MS(diary) pre-exam and PBE as predictors in a model explained 42.7% of the variance of the exam grade (effect size 0.745). Interestingly, MS(diary)--especially during the pre-exam period-was the strongest predictor for the currently achieved grade, along with the preclinical board exam as a covariate, whereas the chronotype did not significantly influence the exam grade.

OSI-930: a novel selective inhibitor of Kit and kinase insert domain receptor tyrosine kinases with antitumor activity in mouse xenograft models.

PubMed

Garton, Andrew J; Crew, Andrew P A; Franklin, Maryland; Cooke, Andrew R; Wynne, Graham M; Castaldo, Linda; Kahler, Jennifer; Winski, Shannon L; Franks, April; Brown, Eric N; Bittner, Mark A; Keily, John F; Briner, Paul; Hidden, Chris; Srebernak, Mary C; Pirrit, Carrie; O'Connor, Matthew; Chan, Anna; Vulevic, Bojana; Henninger, Dwight; Hart, Karen; Sennello, Regina; Li, An-Hu; Zhang, Tao; Richardson, Frank; Emerson, David L; Castelhano, Arlindo L; Arnold, Lee D; Gibson, Neil W

2006-01-15

OSI-930 is a novel inhibitor of the receptor tyrosine kinases Kit and kinase insert domain receptor (KDR), which is currently being evaluated in clinical studies. OSI-930 selectively inhibits Kit and KDR with similar potency in intact cells and also inhibits these targets in vivo following oral dosing. We have investigated the relationships between the potency observed in cell-based assays in vitro, the plasma exposure levels achieved following oral dosing, the time course of target inhibition in vivo, and antitumor activity of OSI-930 in tumor xenograft models. In the mutant Kit-expressing HMC-1 xenograft model, prolonged inhibition of Kit was achieved at oral doses between 10 and 50 mg/kg and this dose range was associated with antitumor activity. Similarly, prolonged inhibition of wild-type Kit in the NCI-H526 xenograft model was observed at oral doses of 100 to 200 mg/kg, which was the dose level associated with significant antitumor activity in this model as well as in the majority of other xenograft models tested. The data suggest that antitumor activity of OSI-930 in mouse xenograft models is observed at dose levels that maintain a significant level of inhibition of the molecular targets of OSI-930 for a prolonged period. Furthermore, pharmacokinetic evaluation of the plasma exposure levels of OSI-930 at these effective dose levels provides an estimate of the target plasma concentrations that may be required to achieve prolonged inhibition of Kit and KDR in humans and which would therefore be expected to yield a therapeutic benefit in future clinical evaluations of OSI-930.

The Impact of Staff Turnover and Staff Density on Treatment Quality in a Psychiatric Clinic

PubMed Central

Brandt, Wolfram A.; Bielitz, Christoph J.; Georgi, Alexander

2016-01-01

Intuition suggests that improving stability of the health workforce brings benefits to staff, the organization and, most importantly, the patients. Unfortunately, there is limited research available to support this, and how health workforce stability can contribute to reduced costs and better treatment outcomes. To help to rectify this situation, we investigated the effects of staff turnover and staff density (staff members per patient) on the treatment outcome of inpatients in a psychiatric clinic. Our data come from the standard assessment of 1429 patients who sought treatment in our clinic from January 2011 to August 2013. Correlation analysis shows no significant effect of raw staff turnover (the total number of psychiatrists, physicians and psychologists starting or quitting work per month) on treatment quality. However, we do find two significant beneficial effects: first, a higher staff consistency (time without staff turnover) and second, a higher staff density lead to an improvement of treatment quality. Our findings underline the dire need for an extended effort to achieve optimal staff retention, both to improve patient’s outcomes and to reduce health expenses. PMID:27065925

A Danish population-based analysis of 105 mantle cell lymphoma patients: incidences, clinical features, response, survival and prognostic factors.

PubMed

Andersen, N S; Jensen, M K; de Nully Brown, P; Geisler, C H

2002-02-01

This study presents the first large clinical analysis of 105 unselected mantle cell lymphoma (MCL) patients diagnosed from 1992 to 2000 in a well-defined Danish population. The annual incidences were 0.7/100000 for men and 0.2/100000 for women, with no significant change during the study period. Of 97 evaluable cases, 43% achieved a complete response (CR) after initial therapy. The median disease-free (DFS) and overall survival (OS) rates were 15 and 30 months, respectively. In multivariate analysis, splenomegaly (P=0.002), anaemia (P=0.0001) and age (P=0.002), but not the international prognostic index (IPI) and the Ann Arbor staging system, had an independent impact on survival. Moreover, in a sub-analysis of 45 younger MCL patients (<65 years), a trend towards an OS plateau of 58% was observed in cases without splenomegaly and anaemia (n=29). Thus, in contrast to previously suggested prognostic factors, these variables may prove useful for clinical decisions in a significant subset of MCL patients.

Efficacy of Exclusive Lingual Nerve Block versus Conventional Inferior Alveolar Nerve Block in Achieving Lingual Soft-tissue Anesthesia.

PubMed

Balasubramanian, Sasikala; Paneerselvam, Elavenil; Guruprasad, T; Pathumai, M; Abraham, Simin; Krishnakumar Raja, V B

2017-01-01

The aim of this randomized clinical trial was to assess the efficacy of exclusive lingual nerve block (LNB) in achieving selective lingual soft-tissue anesthesia in comparison with conventional inferior alveolar nerve block (IANB). A total of 200 patients indicated for the extraction of lower premolars were recruited for the study. The samples were allocated by randomization into control and study groups. Lingual soft-tissue anesthesia was achieved by IANB and exclusive LNB in the control and study group, respectively. The primary outcome variable studied was anesthesia of ipsilateral lingual mucoperiosteum, floor of mouth and tongue. The secondary variables assessed were (1) taste sensation immediately following administration of local anesthesia and (2) mouth opening and lingual nerve paresthesia on the first postoperative day. Data analysis for descriptive and inferential statistics was performed using SPSS (IBM SPSS Statistics for Windows, Version 22.0, Armonk, NY: IBM Corp. Released 2013) and a P < 0.05 was considered statistically significant. In comparison with the control group, the study group (LNB) showed statistically significant anesthesia of the lingual gingiva of incisors, molars, anterior floor of the mouth, and anterior tongue. Exclusive LNB is superior to IAN nerve block in achieving selective anesthesia of lingual soft tissues. It is technically simple and associated with minimal complications as compared to IAN block.

Efficacy of Exclusive Lingual Nerve Block versus Conventional Inferior Alveolar Nerve Block in Achieving Lingual Soft-tissue Anesthesia

PubMed Central

Balasubramanian, Sasikala; Paneerselvam, Elavenil; Guruprasad, T; Pathumai, M; Abraham, Simin; Krishnakumar Raja, V. B.

2017-01-01

Objective: The aim of this randomized clinical trial was to assess the efficacy of exclusive lingual nerve block (LNB) in achieving selective lingual soft-tissue anesthesia in comparison with conventional inferior alveolar nerve block (IANB). Materials and Methods: A total of 200 patients indicated for the extraction of lower premolars were recruited for the study. The samples were allocated by randomization into control and study groups. Lingual soft-tissue anesthesia was achieved by IANB and exclusive LNB in the control and study group, respectively. The primary outcome variable studied was anesthesia of ipsilateral lingual mucoperiosteum, floor of mouth and tongue. The secondary variables assessed were (1) taste sensation immediately following administration of local anesthesia and (2) mouth opening and lingual nerve paresthesia on the first postoperative day. Results: Data analysis for descriptive and inferential statistics was performed using SPSS (IBM SPSS Statistics for Windows, Version 22.0, Armonk, NY: IBM Corp. Released 2013) and a P < 0.05 was considered statistically significant. In comparison with the control group, the study group (LNB) showed statistically significant anesthesia of the lingual gingiva of incisors, molars, anterior floor of the mouth, and anterior tongue. Conclusion: Exclusive LNB is superior to IAN nerve block in achieving selective anesthesia of lingual soft tissues. It is technically simple and associated with minimal complications as compared to IAN block. PMID:29264294

Association between Knowledge-Attitude-Practices and Control of Blood Glucose, Blood Pressure, and Blood Lipids in Patients with Type 2 Diabetes in Shanghai, China: A Cross-Sectional Study.

PubMed

Yang, Hua; Gao, Jian; Ren, Limin; Li, Shuyu; Chen, Zhangyan; Huang, Junfang; Zhu, Shanzhu; Pan, Zhigang

2017-01-01

Knowledge-attitude-practices (KAP) significantly impact the outcome of self-management in patients with diabetes, yet the association between KAP and the combined control of the levels of blood glucose, blood pressure, and blood lipids in these patients remains uncertain. This community-based cross-sectional study was conducted from December 2014 to December 2016 on 3977 patients with type 2 diabetes in Shanghai. KAP were evaluated using the modified Chinese version of the Diabetes, Hypertension and Hyperlipidemia (DHL) Knowledge Instrument, Diabetes Empowerment Scale-Short Form (DES-SF), and Summary of Diabetes Self-Care Activities (SDSCA). Clinical and biochemical measurements were performed at each sampling site. The association between KAP scores and achieving the combined target goal was assessed by multiple logistic regression. Patients having a higher score of knowledge were more likely to achieve the combined target goal. Furthermore, a turning point of knowledge score was found that the possibility of achieving the combined target goal presented a sharp increase when the knowledge score was more than 70. However, the scores of attitude and practices had no significant relations with achieving the combined target goal. Health intervention strategies, especially increasing integrated diabetes knowledge, should be targeted to patients with type 2 diabetes in communities.

Gender and ethnic differences in chronic myelogenous leukemia prognosis and treatment response: a single-institution retrospective study

PubMed Central

Lee, Justin P; Birnstein, Elliott; Masiello, David; Yang, Dongyun; Yang, Allen S

2009-01-01

Background In the last decade the importance of ethnicity, socio-economic and gender differences in relation to disease incidence, diagnosis, and prognosis has been realized. Differences in these areas have become a major health policy focus in the United States. Our study was undertaken to examine the demographic and clinical features of chronic myelogenous leukemia (CML) patients presenting initially at the LAC+USC Medical Center, which serves an ethnically diverse population. Results Patients were evenly split by gender, overwhelmingly Hispanic (60.9%), and quite young (median age 39, range 17–65) compared with previously reported CML patient populations. Previous CML studies identified significant anemia (Hgb <12 g/dl), significant thrombocytosis (platelets >450 × 109/l), and significant leukocytosis (WBC >50 × 109/l) as significant adverse pretreatment prognostic factors. Using these indicators, in addition to the validated Hasford and Sokal scores, patients were stratified and analyzed via gender and ethnicity. A significantly greater proportion of women presented with significant anemia (p = 0.019, Fisher's exact test) and significant thrombocytosis (p = 0.041, Fisher's exact test) compared to men, although no differences were found in risk stratification or treatment response. MCV values for women were significantly (p = 0.02, 2-sample t-test) lower than those for men, suggesting iron deficiency anemia. Focusing on ethnicity, Hispanics as a whole had significantly lower Hasford risk stratification (p = 0.046, Fisher's exact test), and significantly greater likelihood (p = 0.016, Fisher's exact test) of achieving 3-month complete haematological remission (CHR) compared with non-Hispanics at LAC+USC Medical Center, though differences in treatment outcome were no longer significant with analysis limited to patients treated with first-line imatinib. Conclusion Female CML patients at LAC+USC Medical Center present with more significant adverse pre-treatment prognostic factors compared to men, but achieve comparable outcomes. Hispanic patients present with lower risk profile CML and achieve better treatment responses compared to non-Hispanic patients as a whole; these ethnic differences are no longer significant when statistical analysis is limited to patients given imatinib as first-line therapy. Our patients achieve response rates inferior to those of large-scale national studies. This constellation of findings has not been reported in previous studies, and is likely reflective of a unique patient population. PMID:19630970

Predicting corticosteroid-free endoscopic remission with vedolizumab in ulcerative colitis.

PubMed

Waljee, A K; Liu, B; Sauder, K; Zhu, J; Govani, S M; Stidham, R W; Higgins, P D R

2018-03-01

Vedolizumab is an effective therapy for ulcerative colitis (UC), but costly and slow to work. New clinical responses occur after 30 weeks of therapy. To enable physicians, patients, and insurers to predict whether a patient with UC will respond to vedolizumab at an early time point after starting therapy. The clinical study data request website provided the phase 3 clinical trial data for vedolizumab. Random forest models were trained on 70% and tested on 30% of the data to predict corticosteroid-free endoscopic remission at week 52. Models were constructed using baseline data, or data through week 6 of vedolizumab therapy from 491 subjects. The AuROC for prediction of corticosteroid-free endoscopic remission at week 52 using baseline data was only 0.62 (95% CI: 0.53-0.72), but was 0.73 (95% CI: 0.65-0.82) when using data through week 6. A total of 47% of subjects were predicted to be remitters, and 59% of these subjects achieved corticosteroid-free endoscopic remission, in contrast to 21% of the predicted non-remitters. A week 6 prediction using FCP ≤234 μg/g was nearly as accurate. A machine learning algorithm using laboratory data through week 6 of vedolizumab therapy was able to accurately identify which UC patients would achieve corticosteroid-free endoscopic remission on vedolizumab at week 52. Application of this algorithm could have significant implications for clinical decisions on whom to continue on this costly medication when the benefits of the vedolizumab are not clinically apparent in the first 6 weeks of therapy. © 2018 John Wiley & Sons Ltd.

Design and Outcomes of a Comprehensive Care Experience Level System to Evaluate and Monitor Dental Students' Clinical Progress.

PubMed

Teich, Sorin T; Roperto, Renato; Alonso, Aurelio A; Lang, Lisa A

2016-06-01

A Comprehensive Care Experience Level (CCEL) system that is aligned with Commission on Dental Accreditation (CODA) standards, promotes comprehensive care and prevention, and addresses flaws observed in previous Relative Value Units (RVU)-based programs has been implemented at the School of Dental Medicine, Case Western Reserve University since 2011. The purpose of this article is to report on the design, implementation, and preliminary outcomes of this novel clinical evaluation system. With the development of the CCEL concept, it was decided not to award points for procedures performed on competency exams. The reason behind this decision was that exams are not learning opportunities and are evaluated with summative tools. To determine reasonable alternative requirements, production data from previous classes were gathered and translated into CCEL points. These RVU points had been granted selectively only for restorative procedures completed after the initial preparation stage of the treatment plan, and achievement of the required levels was checked at multiple points during the clinical curriculum. Results of the CCEL system showed that low performing students increased their productivity, overall production at graduation increased significantly, and fluoride utilization to prevent caries rose by an order of magnitude over the RVU system. The CCEL program also allowed early identification and remediation of students having difficulty in the clinic. This successful implementation suggests that the CCEL concept has the potential for widespread adoption by dental schools. This method also can be used as a behavior modification tool to achieve specific patient care or clinical educational goals as illustrated by the way caries prevention was promoted through the program.

Cordova: Web-based management of genetic variation data

PubMed Central

Ephraim, Sean S.; Anand, Nikhil; DeLuca, Adam P.; Taylor, Kyle R.; Kolbe, Diana L.; Simpson, Allen C.; Azaiez, Hela; Sloan, Christina M.; Shearer, A. Eliot; Hallier, Andrea R.; Casavant, Thomas L.; Scheetz, Todd E.; Smith, Richard J. H.; Braun, Terry A.

2014-01-01

Summary: Cordova is an out-of-the-box solution for building and maintaining an online database of genetic variations integrated with pathogenicity prediction results from popular algorithms. Our primary motivation for developing this system is to aid researchers and clinician–scientists in determining the clinical significance of genetic variations. To achieve this goal, Cordova provides an interface to review and manually or computationally curate genetic variation data as well as share it for clinical diagnostics and the advancement of research. Availability and implementation: Cordova is open source under the MIT license and is freely available for download at https://github.com/clcg/cordova. Contact: sean.ephraim@gmail.com or terry-braun@uiowa.edu PMID:25123904

Clinical and Radiographic Response of Extramedullary Leukemia in Patients Treated With Gemtuzumab Ozogamicin.

PubMed

McNeil, Michael J; Parisi, Marguerite T; Hijiya, Nobuko; Meshinchi, Soheil; Cooper, Todd; Tarlock, Katherine

2018-05-04

Extramedullary leukemia (EML) is common in pediatric acute leukemia and can present at diagnosis or relapse. CD33 is detected on the surface of myeloid blasts in many patients with acute myelogenous leukemia and is the target of the antibody drug conjugate gemtuzumab ozogamicin (GO). Here we present 2 patients with CD33 EML treated with GO. They achieved significant response, with reduction of EML on both clinical and radiographic exams, specifically fluorine fluorodeoxyglucose positron emission tomography/computed tomography, demonstrating potential for targeted therapy with GO as a means of treating EML in patients with CD33 leukemia and the utility of fluorine fluorodeoxyglucose positron emission tomography/computed tomography monitoring in EML.

Guidelines for Initiating a Research Agenda: Topic Selection and Evidence of Impact.

PubMed

Delost, Maria E; Nadder, Teresa S

2014-01-01

The focus on scholarly productivity as an outcome measure for performance evaluations of personnel and/or units and benchmarking purposes is increasing in both the academic and clinical settings. This article presents avenues for identifying achievable research projects in both the academic and clinical settings. Factors for consideration when selecting a project include its significance or impact on the profession, feasibility for implementing the project, and ethical issues related to human subjects protection. A review of the literature is essential for identifying gaps in knowledge and for constructing the hypothesis or research question. Decisions concerning IRB submission, budget allocation, and collection of data must also be considered before implementation of the research design.

Bringing DNA vaccines closer to commercial use.

PubMed

Carvalho, Joana A; Prazeres, Duarte M F; Monteiro, Gabriel A

2009-10-01

Progress in the application of DNA vaccines as an immunization protocol is evident from the increasing number of such vaccines under evaluation in clinical trials and by the recent approval of several DNA vaccine products for veterinary applications. DNA vaccine technology offers important therapeutic and commercial advantages compared with conventional approaches, including the opportunity to target pathogens characterized by significant genetic diversity using a safe immunization platform, and the ability to use a simple, rapid and well-characterized production method. However, further optimization of DNA vaccine technology through the use of improved constructs, delivery systems and immunization protocols is necessary to clinically achieve the promising results that have been demonstrated in preclinical models.

Precision diagnostics: moving towards protein biomarker signatures of clinical utility in cancer.

PubMed

Borrebaeck, Carl A K

2017-03-01

Interest in precision diagnostics has been fuelled by the concept that early detection of cancer would benefit patients; that is, if detected early, more tumours should be resectable and treatment more efficacious. Serum contains massive amounts of potentially diagnostic information, and affinity proteomics has risen as an accurate approach to decipher this, to generate actionable information that should result in more precise and evidence-based options to manage cancer. To achieve this, we need to move from single to multiplex biomarkers, a so-called signature, that can provide significantly increased diagnostic accuracy. This Opinion article focuses on the progress being made in identifying protein biomarker signatures of clinical utility, using blood-based proteomics.

[Diagnosis and surgical management in gastrointestinal neuroendocrine tumors].

PubMed

Tomulescu, V; Stănciulea, O; Dima, S; Herlea, V; Stoica Mustafa, E; Dumitraşcu, T; Pechianu, C; Popescu, I

2011-01-01

Neuroendocrine tumors, known as carcinoid tumors constitute a heterogeneous group of neoplasms that present many clinical challenges. They secrete peptides and neuroamines that cause specific clinical syndromes. Assessment of specific or general tumors markers offers high sensitivity in establishing the diagnosis and they also have prognostic significance. Management strategies include curative surgery, whenever possible-that can be rarely achieved, palliative surgery, chemotherapy, radiologic therapy, such as radiofrequency ablation and chemoembolisations and somatostatin analogues therapy in order to control the symptoms. The aim of this paper is to review recent publications in this field and to give recommendations that take into account current advances in order to facilitate improvement in management and outcome.

The drug-induced degradation of oncoproteins: an unexpected Achilles' heel of cancer cells?

PubMed

Ablain, Julien; Nasr, Rihab; Bazarbachi, Ali; de Thé, Hugues

2011-07-01

Many targeted therapies against cancer are aimed at inhibiting the enzymatic activity of kinases. Thus far, this approach has undoubtedly yielded significant clinical improvements, but has only rarely achieved cures. Other drugs, which selectively elicit proteasome-dependent degradation of oncoproteins, induce the loss of cancer cell self-renewal and promote cell differentiation and/or apoptosis. In acute promyelocytic leukemia, the cooperative degradation of PML/RARA by arsenic and retinoic acid cures most patients. In this condition and others, drug-induced proteolysis of oncoproteins is feasible and underlies improved clinical outcome. Several transcription factors, nuclear receptors, or fusion proteins driving cancer growth could be candidates for proteolysis-based drug-discovery programs.

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

Ranganathan, V; Kumar, P; Bzdusek, K

Purpose: We propose a novel data-driven method to predict the achievability of clinical objectives upfront before invoking the IMRT optimization. Methods: A new metric called “Geometric Complexity (GC)” is used to estimate the achievability of clinical objectives. Here, GC is the measure of the number of “unmodulated” beamlets or rays that intersect the Region-of-interest (ROI) and the target volume. We first compute the geometric complexity ratio (GCratio) between the GC of a ROI (say, parotid) in a reference plan and the GC of the same ROI in a given plan. The GCratio of a ROI indicates the relative geometric complexitymore » of the ROI as compared to the same ROI in the reference plan. Hence GCratio can be used to predict if a defined clinical objective associated with the ROI can be met by the optimizer for a given case. Basically a higher GCratio indicates a lesser likelihood for the optimizer to achieve the clinical objective defined for a given ROI. Similarly, a lower GCratio indicates a higher likelihood for the optimizer to achieve the clinical objective defined for the given ROI. We have evaluated the proposed method on four Head and Neck cases using Pinnacle3 (version 9.10.0) Treatment Planning System (TPS). Results: Out of the total of 28 clinical objectives from four head and neck cases included in the study, 25 were in agreement with the prediction, which implies an agreement of about 85% between predicted and obtained results. The Pearson correlation test shows a positive correlation between predicted and obtained results (Correlation = 0.82, r2 = 0.64, p < 0.005). Conclusion: The study demonstrates the feasibility of the proposed method in head and neck cases for predicting the achievability of clinical objectives with reasonable accuracy.« less

Curriculum gaps in teaching clinical skills to Iranian undergraduate medical students.

PubMed

Mirzazadeh, Azim; Bavarian, Behrouz; Labaf, Ali; Afshari, Ali; Nikoo, Mohammad; Meshkani, Zahra Sadat; Khashayar, Patricia

2013-04-20

The inefficacy of clinical skill education during the clerkship has been reported in several studies. The present study was conducted to evaluate the competency of medical students in performing several clinical skills through an Objective Structured Clinical Examination (OSCE), aiming to evaluate the quality of the existing curriculum in the clerkship phase. The cross sectional study was conducted at the end of the clerkship period, before the students had entered the internship. The OSCE exam was conducted in the morning (2 different tracts) and in the evening (2 similar tracts) and 86 students participated in the exam. Each tract consisted of seven stations. The students' points in the stations assessing history taking and clinical skills were compared. The students gained the highest points in the history taking stations, whereas the procedure stations accounted for the lowest points; there was a significant difference between these stations (p < 0.001). The female students achieved higher scores in the OSCE exam compared to males (p = 0.004). The OSCE exam revealed the inefficacy of the current medical curriculum in teaching the required clinical skill to undergraduate medical students during the clerkship.

Design and development of reactive injectable and settable polymeric biomaterials.

PubMed

Page, Jonathan M; Harmata, Andrew J; Guelcher, Scott A

2013-12-01

Injectable and settable biomaterials are a growing class of therapeutic technologies within the field of regenerative medicine. These materials offer advantages compared to prefabricated implants because of their ability to be utilized as part of noninvasive surgical procedures, fill complex defect shapes, cure in situ, and incorporate cells and other active biologics. However, there are significant technical barriers to clinical translation of injectable and settable biomaterials, such as achieving clinically relevant handling properties and benign reaction conditions. This review focuses on the engineering challenges associated with the design and development of injectable and chemically settable polymeric biomaterials. Additionally, specific examples of the diverse chemistries utilized to overcome these challenges are covered. The future translation of injectable and settable biomaterials is anticipated to improve patient outcomes for a number of clinical conditions. Copyright © 2013 Wiley Periodicals, Inc., a Wiley Company.

Review of the progress toward achieving heat confinement-the holy grail of photothermal therapy

NASA Astrophysics Data System (ADS)

Sheng, Wangzhong; He, Sha; Seare, William J.; Almutairi, Adah

2017-08-01

Photothermal therapy (PTT) involves the application of normally benign light wavelengths in combination with efficient photothermal (PT) agents that convert the absorbed light to heat to ablate selected cancers. The major challenge in PTT is the ability to confine heating and thus direct cellular death to precisely where PT agents are located. The dominant strategy in the field has been to create large libraries of PT agents with increased absorption capabilities and to enhance their delivery and accumulation to achieve sufficiently high concentrations in the tissue targets of interest. While the challenge of material confinement is important for achieving "heat and lethality confinement," this review article suggests another key prospective strategy to make this goal a reality. In this approach, equal emphasis is placed on selecting parameters of light exposure, including wavelength, duration, power density, and total power supplied, based on the intrinsic properties and geometry of tissue targets that influence heat dissipation, to truly achieve heat confinement. This review highlights significant milestones researchers have achieved, as well as examples that suggest future research directions, in this promising technique, as it becomes more relevant in clinical cancer therapy and other noncancer applications.

Outcomes assessment of dental hygiene clinical teaching workshops.

PubMed

Wallace, Juanita S; Infante, Taline D

2008-10-01

Faculty development courses related to acquiring clinical teaching skills in the health professions are limited. Consequently, the Department of Dental Hygiene at the University of Texas Health Science Center at San Antonio conducted a series of clinical teaching workshops to address clinical teaching methodology. The goal of these workshops was to promote a problem-solving learning atmosphere for dental hygiene faculty to acquire and share sound clinical teaching strategies. To determine the value of the annual workshops on clinical teaching and evaluation, a web-based qualitative program assessment was developed using software by Survey Tracker. Four open-ended questions were designed to elicit perceptions regarding what significant changes in teaching strategies were achieved, what barriers or challenges were encountered in making these changes, and what strategies were used to overcome the barriers. The assessment was sent to dental hygiene educators representing thirty-eight dental hygiene programs who had participated in two or more of these workshops. Twenty-eight programs provided collective responses to the questions, and the narrative data were analyzed, using a qualitative methodology. Responses revealed that programs had made productive changes to their clinical education curricula and the information gained from the workshops had a positive effect on clinical teaching.

TAC-TIC use of tacrolimus-based regimens in lupus nephritis

PubMed Central

Bredewold, Obbo W; Trompet, Stella; Huizinga, Tom W J; Rabelink, Ton J; de Craen, Anton J M; Teng, Y K Onno

2016-01-01

Current guidelines do not mention tacrolimus (TAC) as a treatment option and no consensus has been reported on the role of TAC in lupus nephritis (LN). The present study aimed to guide clinical judgement on the use of TAC in patients with LN. A meta-analysis was performed for clinical studies investigating TAC regimens in LN on the basis of treatment target (induction or maintenance), concomitant immunosuppression and quality of the data. 23 clinical studies performed in patients with LN were identified: 6 case series, 9 cohort studies, 2 case-control studies and 6 randomised controlled trials (RCTs). Of the 6 RCTs, 5 RCTs investigated TAC regimens as induction treatment and 1 RCT as maintenance treatment. Five RCTs investigated TAC in combination with steroids and 2 TAC with mycophenolate plus steroids. All RCTs were performed in patients of Asian ethnicity. In a meta-analysis, TAC regimens achieved a significantly higher total response (relative risk (RR) 1.23, 95% CI 1.12 to 1.34, p<0.05) and significantly higher complete response (RR 1.48, 95% CI 1.23 to 1.77, p<0.05). The positive outcome was predominantly defined by the largest RCT investigating TAC with mycophenolate plus steroids. Regarding safety, the occurrence of leucopoenia was significantly lower, while the occurrence of increased creatine was higher. Clinical studies on TAC regimens for LN are limited to patients of Asian ethnicity and hampered by significant heterogeneity. The positive results on clinical efficacy of TAC as induction treatment in LN cannot be extrapolated beyond Asian patients with LN. Therefore, further confirmation in multiethnic, randomised trials is mandatory. Until then, TAC can be considered in selected patients with LN. PMID:28123768

Extrafascial versus interfascial nerve-sparing technique for robotic-assisted laparoscopic prostatectomy: comparison of functional outcomes and positive surgical margins characteristics.

PubMed

Shikanov, Sergey; Woo, Jason; Al-Ahmadie, Hikmat; Katz, Mark H; Zagaja, Gregory P; Shalhav, Arieh L; Zorn, Kevin C

2009-09-01

To evaluate the pathologic and functional outcomes of patients with bilateral interfascial (IF) or extrafascial nerve-sparing (EF-NSP) techniques. It is believed that the IF-NSP technique used during robotic-assisted radical prostatectomy (RARP) spares more nerve fibers, while EF dissection may lower the risk for positive surgical margins (PSM). A prospective database was analyzed for RARP patients with bilateral IF- or EF-NSP technique. Collected parameters included age, body mass index, prostate-specific antigen, clinical and pathologic Gleason score and stage, estimated blood loss, operative time, and PSM characteristics. Functional outcomes were evaluated with the use of the University of California Los Angeles Prostate Cancer Index questionnaire. Men receiving postoperative hormonal or radiation therapy were excluded from sexual function analysis. A total of 110 and 703 cases with bilateral EF- and IF-NSP, respectively, were analyzed. EF-NSP patients had higher prostate-specific antigen, clinical, pathologic stage, and pathologic Gleason score. PSM rate did not achieve statistically significant difference between groups. There was a trend toward lower pT3-PSM in the EF group (51% vs 28%; P = .08). Mid- and posterolateral PSM location were lower in the EF-NSP group, 11% vs 37% and 11% vs 29%, respectively (P < .001). The IF-NSP group patients achieved statistically significant better sexual function (P = .02) and potency rates (P = .03) at 12 months after RARP. In lower risk patients, bilateral IF-NSP technique does not result in significantly higher PSM rates. EF-NSP appears to reduce posterolateral and mid-prostate PSM. Men with bilateral IF-NSP demonstrate significantly better sexual function outcomes.

U.S. health professionals' views on obesity care, training, and self-efficacy.

PubMed

Bleich, Sara N; Bandara, Sachini; Bennett, Wendy L; Cooper, Lisa A; Gudzune, Kimberly A

2015-04-01

Despite emphasis of recent guidelines on multidisciplinary teams for collaborative weight management, little is known about non-physician health professionals' perspectives on obesity, their weight management training, and self-efficacy for obesity care. To evaluate differences in health professionals' perspectives on (1) the causes of obesity; (2) training in weight management; and (3) self-efficacy for providing obesity care. Data were obtained from a cross-sectional Internet-based survey of 500 U.S. health professionals from nutrition, nursing, behavioral/mental health, exercise, and pharmacy (collected from January 20 through February 5, 2014). Inferences were derived using logistic regression adjusting for age and education (analyzed in 2014). Nearly all non-physician health professionals, regardless of specialty, cited individual-level factors, such as overconsumption of food (97%), as important causes of obesity. Nutrition professionals were significantly more likely to report high-quality training in weight management (78%) than the other professionals (nursing, 53%; behavioral/mental health, 32%; exercise, 50%; pharmacy, 47%; p<0.05). Nutrition professionals were significantly more likely to report high confidence in helping obese patients achieve clinically significant weight loss (88%) than the other professionals (nursing, 61%; behavioral/mental health, 51%; exercise, 52%; pharmacy, 61%; p<0.05), and more likely to perceive success in helping patients with obesity achieve clinically significant weight loss (nutrition, 81%; nursing, behavioral/mental health, exercise, and pharmacy, all <50%; p<0.05). Nursing, behavioral/mental health, exercise, and pharmacy professionals may need additional training in weight management and obesity care to effectively participate in collaborative weight management models. Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Undergraduate Nurse Variables that Predict Academic Achievement and Clinical Competence in Nursing

ERIC Educational Resources Information Center

Blackman, Ian; Hall, Margaret; Darmawan, I Gusti Ngurah.

2007-01-01

A hypothetical model was formulated to explore factors that influenced academic and clinical achievement for undergraduate nursing students. Sixteen latent variables were considered including the students' background, gender, type of first language, age, their previous successes with their undergraduate nursing studies and status given for…

Safety and effectiveness of adalimumab in a clinical setting that reflects Canadian standard of care for the treatment of rheumatoid arthritis (RA): results from the CanACT study.

PubMed

Haraoui, Boulos; Cividino, Alfred; Stewart, Jacqueline; Guérette, Benoît; Keystone, Edward C

2011-11-17

This multicenter, open-label, prospective, single cohort study evaluated the effectiveness and safety of adalimumab in a clinical setting reflecting the Canadian standard of care for the treatment of patients with rheumatoid arthritis (RA). Patients ≥ 18 years of age with a history of active RA ≥ 3 months and fulfilling Canadian requirements for biological therapy received adalimumab 40 mg subcutaneously every other week for 12 weeks. Pre-study DMARD treatment regimens, corticosteroids, or NSAIDs were allowed throughout the study. The primary effectiveness outcome measure was the mean change in 28-joint disease activity score (DAS28) from baseline to Week 12. Secondary measures included the proportion of patients achieving joint remission (DAS28 < 2.6) and low-disease activity (DAS28 < 3.2) at Week 12, and European League Against Rheumatism (EULAR: moderate and good) and American College of Rheumatology (ACR: ACR20, 50, and 70) responses, as well as responses in ACR core components at Weeks 4, 8, and 12. Subgroup analysis included a comparison of patients naïve to biological DMARD (BDMARD) therapy versus BDMARD-experienced patients. Safety was assessed in terms of adverse and serious adverse events. A total of 879 patients (mean disease duration > 12 years) were enrolled; 772 (87.9%) completed the 12-week period. Adalimumab treatment was associated with rapid and sustained improvements in the signs and symptoms of RA. Significant improvements in mean DAS28 score were observed as early as Week 4. After 12 weeks of adalimumab treatment, 15.3% and 28.9% of patients achieved clinical remission and low-disease activity, respectively. Similarly, significant improvements in ACR core components were observed as early as Week 4, with continued improvements occurring through 12 weeks. Patients naïve to BDMARD therapy demonstrated numerically greater clinical responses when compared with patients who had experienced prior BDMARD therapy, although both subgroups were associated with significant improvements from baseline. The rates and types of adverse events, as well as the results of laboratory measures, demonstrated that adalimumab was generally safe and well-tolerated. This study demonstrated that, under conditions reflective of the normal clinical practice in Canada, adalimumab is an effective and safe treatment for patients with RA. NCT00649545.

Free‑floating cancer cells in lymph node sinuses of hilar lymph node‑positive patients with non‑small cell lung cancer.

PubMed

Nakamura, Yusuke; Mukai, Masaya; Hiraiwa, Shinichiro; Kishima, Kyoko; Sugiyama, Tomoko; Tajiri, Takuma; Yamada, Shunsuke; Iwazaki, Masayuki

2018-05-14

Previous studies demonstrated that free‑floating cancer cells (FFCCs) in the lymph node sinuses were of prognostic significance for colorectal and gastric cancer. The present study investigated the clinical significance of detecting FFCCs using Fast Red staining for cytokeratin in stage I/II non‑small cell lung cancer (NSCLC) patients and hilar lymph node positive NSCLC patients who underwent curative resection. Between 2002 and 2011, a total of 164 patients (including 22 hilar lymph node positive patients) were investigated. Resected lymph nodes were stained for cytokeratin using an anti‑cytokeratin antibody. In order to achieve a clear distinction from coal dust, an anti‑cytokeratin antibody was labeled with a secondary antibody conjugated with alkaline phosphatase, which was detected by a reaction with Fast Red/naphthol that produced a red color. Patients were considered to be positive for FFCCs (FFCCs+) if one or more than one free‑floating cytokeratin‑positive cell was detected in the lymph node sinuses, which could not be detected by hematoxylin and eosin staining. Among all 164 patients, a significant difference was observed in 5‑year relapse‑free survival (5Y‑RFS) rates, with 76.9 and 33.3% being achieved by FFCCs‑ and FFCCs+ patients, respectively (P<0.001). Similarly, the 5‑year overall survival (5Y‑OS) rate was significantly lower in FFCCs+ patients, with 86.6% being achieved by FFCCs‑ and 65.8% by FFCCs+ patients, respectively (P=0.014). Among 22 hilar lymph node‑positive patients, a significant difference was also observed in 5Y‑RFS, with 53.8 and 0.0% being achieved by FFCCs‑ and FFCCs+ patients, respectively (P=0.006). The 5Y‑OS tended to be lower in FFCCs+ patients, with 69.2 and 53.3% being achieved by FFCCs‑ and FFCCs+ patients, respectively (P=0.463). The findings of the present study suggested the presence of FFCCs in stage I/II NSCLC patients was associated with a poor prognosis. In addition, FFCCs in hilar lymph node‑positive patients may potential be a useful marker in foreseeing the recurrence of cancer.

[Dapagliflozin: Beyond glycemic control in the treatment of type 2 diabetes mellitus].

PubMed

Sanz-Serra, Pol; Pedro-Botet, Juan; Flores-Le Roux, Juana A; Benaiges, David; Chillarón, Juan J

2015-01-01

Patients with type 2 diabetes mellitus (T2DM) have a high or very high cardiovascular risk. The clinical practice guidelines focus on the need to achieve optimal glycemic control, and strategies for a multifactorial therapeutic approach have shown significant cardiovascular benefits in these patients. Inhibitors of sodium-glucose co-transporter 2 (SGLT-2) are a new class of orally administered drugs in the treatment of T2DM, which act by inhibiting reabsorption of glucose in the renal proximal tubule with consequent glycosuric effect and lowering of blood glucose. Dapagliflozin, SGLT-2 inhibitor marketed in Europe and Australia, has been shown to achieve glycosylated hemoglobin reductions similar to other oral agents, as well as beneficial effects on major comorbidities associated with T2DM. Therefore, it is considered of interest to review the clinical efficacy of this new oral hypoglycemic on glycemic control, risk of hypoglycemia, and its impact on body weight, blood pressure, lipid profile and renal function. Copyright © 2014 Sociedad Española de Arteriosclerosis. Published by Elsevier España. All rights reserved.

Cetuximab plus FOLFOX for Patients with Metastatic Colorectal Cancer with Poor Performance Status and/or Severe Tumor-Related Complications

PubMed Central

Shitara, Kohei; Yokota, Tomoya; Takahari, Daisuke; Shibata, Takashi; Sato, Yozo; Tajika, Masahiro; Ura, Takashi; Muro, Kei

2010-01-01

Introduction Cetuximab-based chemotherapy showed a statistically significantly higher response rate compared with chemotherapy such as FOLFOX. Therefore, FOLFOX plus cetuximab is suspected to be the best regimen to alleviate tumor-related symptoms with a high response rate. Case Report Here we present the results of 8 consecutive patients with metastatic colorectal cancer with poor performance status and/or severe complications who were treated with first-line FOLFOX with cetuximab. Six of 8 patients achieved an apparent clinical benefit, including radiological response and symptoms improvement. Two patients with BRAF mutation could achieve neither clinical benefit nor radiological response. Conclusion Although an optimal line of therapy with cetuximab is unclear yet with bevacizumab in mind, we propose that patients who need a tumor response to alleviate their symptoms due to advanced disease might be candidates for first-line cetuximab-based therapy as shown in our cases. Additionally, patients with BRAF mutant tumors might be important candidates for novel targeted therapy in the future to improve their poor prognosis. PMID:21347194

A Single-Institution Experience in Percutaneous Image-Guided Biopsy of Malignant Pleural Mesothelioma

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

Welch, B. T., E-mail: Welch.brian@mayo.edu; Eiken, P. W.; Atwell, T. D.

PurposeMesothelioma has been considered a difficult pathologic diagnosis to achieve via image-guided core needle biopsy. The purpose of this study was to assess the diagnostic sensitivity of percutaneous image-guided biopsy for diagnosis of pleural mesothelioma.Materials and MethodsRetrospective review was performed to identify patients with a confirmed diagnosis of pleural mesothelioma and who underwent image-guided needle biopsy between January 1, 2002, and January 1, 2016. Thirty-two patients with pleural mesothelioma were identified and included for analysis in 33 image-guided biopsy procedures. Patient, procedural, and pathologic characteristics were recorded. Complications were characterized via standardized nomenclature [Common Terminology for Clinically Adverse Events (CTCAE)].ResultsPercutaneousmore » image-guided biopsy was associated with an overall sensitivity of 81%. No CTCAE clinically significant complications were observed. No image-guided procedures were complicated by pneumothorax or necessitated chest tube placement. No patients had tumor seeding of the biopsy tract.ConclusionPercutaneous image-guided biopsy can achieve high sensitivity for pathologic diagnosis of pleural mesothelioma with a low procedural complication rate, potentially obviating need for surgical biopsy.« less

Prevalence of remission and its effect on damage and quality of life in Chinese patients with systemic lupus erythematosus.

PubMed

Mok, Chi Chiu; Ho, Ling Yin; Tse, Sau Mei; Chan, Kar Li

2017-08-01

To study the prevalence of remission and its effect on damage and quality of life (QOL) in Chinese patients with systemic lupus erythematosus (SLE). Patients who fulfilled ≥4 American College of Rheumatology criteria for SLE were identified. Their remission status at last clinic visits was determined by the European consensus criteria (complete/clinical remission ± immunosuppressive drugs). The increase in SLE damage index (SDI) in the preceding 5 years was compared between patients who were and were not in remission for ≥5 years. QOL of patients as assessed by the validated Chinese version of the Medical Outcomes Study Short-Form-36 (SF36) and the LupusPRO was also compared between the remission and non-remission groups by statistical analysis. 769 SLE patients were studied (92% women; age: 46.4±14.6 years; SLE duration: 12.6±8.1 years). At last visit, clinical remission was present in 259 (33.7%) patients and complete remission was present in 280 (36.4%) patients. Clinical and complete remissions for ≥5 years were achieved in 64 (8.3%) and 129 (16.8%) of the patients, respectively. Patients remitted for ≥5 years were older, and had significantly lower prevalence of renal involvement, leucopenia or thrombocytopaenia. Fifty-three (6.9%) patients in remission ≥5 years were taken off all medications, including hydroxychloroquine (HCQ) (drug-free). Patients who remitted for ≥5 years but off-therapy (except HCQ) had significantly less SDI increment than those who did not remit (0.17±0.53 vs 0.67±1.10; p<0.001). Among 453 patients who had QOL assessment, remission for ≥5 years was associated with significantly higher SF36 and the total health-related scores of the LupusPRO. Durable remission can be achieved in a quarter of patients with SLE. Patients with remission for ≥5 years have significantly less damage accrual and better QOL. Prolonged remission is an appropriate criterion for outcome assessment in SLE. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Achieving quality assurance through clinical audit.

PubMed

Patel, Seraphim

2010-06-01

Audit is a crucial component of improvements to the quality of patient care. Clinical audits are undertaken to help ensure that patients can be given safe, reliable and dignified care, and to encourage them to self-direct their recovery. Such audits are undertaken also to help reduce lengths of patient stay in hospital, readmission rates and delays in discharge. This article describes the stages of clinical audit and the support required to achieve organisational core values.

A study of active learning methods for named entity recognition in clinical text.

PubMed

Chen, Yukun; Lasko, Thomas A; Mei, Qiaozhu; Denny, Joshua C; Xu, Hua

2015-12-01

Named entity recognition (NER), a sequential labeling task, is one of the fundamental tasks for building clinical natural language processing (NLP) systems. Machine learning (ML) based approaches can achieve good performance, but they often require large amounts of annotated samples, which are expensive to build due to the requirement of domain experts in annotation. Active learning (AL), a sample selection approach integrated with supervised ML, aims to minimize the annotation cost while maximizing the performance of ML-based models. In this study, our goal was to develop and evaluate both existing and new AL methods for a clinical NER task to identify concepts of medical problems, treatments, and lab tests from the clinical notes. Using the annotated NER corpus from the 2010 i2b2/VA NLP challenge that contained 349 clinical documents with 20,423 unique sentences, we simulated AL experiments using a number of existing and novel algorithms in three different categories including uncertainty-based, diversity-based, and baseline sampling strategies. They were compared with the passive learning that uses random sampling. Learning curves that plot performance of the NER model against the estimated annotation cost (based on number of sentences or words in the training set) were generated to evaluate different active learning and the passive learning methods and the area under the learning curve (ALC) score was computed. Based on the learning curves of F-measure vs. number of sentences, uncertainty sampling algorithms outperformed all other methods in ALC. Most diversity-based methods also performed better than random sampling in ALC. To achieve an F-measure of 0.80, the best method based on uncertainty sampling could save 66% annotations in sentences, as compared to random sampling. For the learning curves of F-measure vs. number of words, uncertainty sampling methods again outperformed all other methods in ALC. To achieve 0.80 in F-measure, in comparison to random sampling, the best uncertainty based method saved 42% annotations in words. But the best diversity based method reduced only 7% annotation effort. In the simulated setting, AL methods, particularly uncertainty-sampling based approaches, seemed to significantly save annotation cost for the clinical NER task. The actual benefit of active learning in clinical NER should be further evaluated in a real-time setting. Copyright © 2015 Elsevier Inc. All rights reserved.

Continuous infusion of beta-lactam antibiotics in severe infections: a review of its role.

PubMed

Roberts, Jason A; Paratz, Jennifer; Paratz, Elizabeth; Krueger, Wolfgang A; Lipman, Jeffrey

2007-07-01

Continuous infusion of beta-lactam antibiotics has been widely promoted to optimise their time-dependent activity. Increasing evidence is emerging suggesting potential benefits in patient populations with altered pathophysiology, such as seriously ill patients. From a pharmacokinetic viewpoint, much information supports higher trough concentrations of beta-lactam antibiotics when administered by continuous infusion. This advantage of continuous infusion translates into a superior ability to achieve pharmacodynamic targets, particularly when the minimum inhibitory concentration (MIC) of the pathogen is >or=4 mg/L. One drawback of continuous infusion may be limited physicochemical stability. This issue exists particularly for carbapenem antibiotics whereby prolonged infusions (i.e. >3h) can be used to improve the time above the MIC compared with conventional bolus dosing. Few studies have examined clinical outcomes of bolus and continuous dosing of beta-lactam antibiotics in seriously ill patients. No statistically significant differences have been shown for: mortality; time to normalisation of leukocytosis or pyrexia; or duration of mechanical ventilation, intensive care unit stay or hospital stay. Some evidence suggests improved clinical cure and resolution of illness with continuous infusion in seriously ill patients. Pharmacoeconomic advantages of continuous infusion of beta-lactam antibiotics are well characterised. Available data suggest that seriously ill patients with severe infections requiring significant antibiotic courses (>or=4 days) may be the subgroup that will achieve better outcomes with continuous infusion.

Detection of recurrent activation patterns across focal seizures: Application to seizure onset zone identification.

PubMed

Vila-Vidal, Manel; Principe, Alessandro; Ley, Miguel; Deco, Gustavo; Tauste Campo, Adrià; Rocamora, Rodrigo

2017-06-01

We introduce a method that quantifies the consistent involvement of intracranially monitored regions in recurrent focal seizures. We evaluated the consistency of two ictal spectral activation patterns (mean power change and power change onset time) in intracranial recordings across focal seizures from seven patients with clinically marked seizure onset zone (SOZ). We examined SOZ discrimination using both patterns in different frequency bands and periods of interest. Activation patterns were proved to be consistent across more than 80% of recurrent ictal epochs. In all patients, whole-seizure mean activations were significantly higher for SOZ than non-SOZ regions (P<0.05) while activation onset times were significantly lower for SOZ than for non-SOZ regions (P<0.001) in six patients. Alpha-beta bands (8-20Hz) achieved the highest patient-average effect size on the whole-seizure period while gamma band (20-70Hz) achieved the highest discrimination values between SOZ and non-SOZ sites near seizure onset (0-5s). Consistent spectral activation patterns in focal epilepsies discriminate the SOZ with high effect sizes upon appropriate selection of frequency bands and activation periods. The present method may be used to improve epileptogenic identification as well as pinpoint additional regions that are functionally altered during ictal events. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): Rationale for a Tailored Behavioral and Educational Pharmacist-Administered Intervention for Achieving Cardiovascular Disease Risk Reduction

PubMed Central

Zullig, Leah L.; Melnyk, S. Dee; Stechuchak, Karen M.; McCant, Felicia; Danus, Susanne; Oddone, Eugene; Bastian, Lori; Olsen, Maren; Edelman, David; Rakley, Susan; Morey, Miriam

2014-01-01

Abstract Background: Hypertension, hyperlipidemia, and diabetes are significant, but often preventable, contributors to cardiovascular disease (CVD) risk. Medication and behavioral nonadherence are significant barriers to successful hypertension, hyperlidemia, and diabetes management. Our objective was to describe the theoretical framework underlying a tailored behavioral and educational pharmacist-administered intervention for achieving CVD risk reduction. Materials and Methods: Adults with poorly controlled hypertension and/or hyperlipidemia were enrolled from three outpatient primary care clinics associated with the Durham Veterans Affairs Medical Center (Durham, NC). Participants were randomly assigned to receive a pharmacist-administered, tailored, 1-year telephone-based intervention or usual care. The goal of the study was to reduce the risk for CVD through a theory-driven intervention to increase medication adherence and improve health behaviors. Results: Enrollment began in November 2011 and is ongoing. The target sample size is 500 patients. Conclusions: The Cardiovascular Intervention Improvement Telemedicine Study (CITIES) intervention has been designed with a strong theoretical underpinning. The theoretical foundation and intervention are designed to encourage patients with multiple comorbidities and poorly controlled CVD risk factors to engage in home-based monitoring and tailored telephone-based interventions. Evidence suggests that clinical pharmacist-administered telephone-based interventions may be efficiently integrated into primary care for patients with poorly controlled CVD risk factors. PMID:24303930

Study on the effectiveness of the kinetic method in patients with rheumatic diseases and temporomandibular joint dysfunction.

PubMed

Havriş, Maria Daniela; Ancuţa, Codrina; Iordache, Cristina; Chirieac, Rodica Marieta

2012-01-01

Selecting the appropriate treatment decision is essential for achieving optimal results in the management of algo-dysfunctional syndrome of the temporo-mandibular joint (TMJD). The study aims to decide on the most effective (symptomatic control, preserved motility) kinetic program in patients with TMJ involvement. prospective observational study on 83 consecutive patients with rheumatic diseases and TMJ dysfunction. Clinical assessment (pain, noises, muscle spasm, range of motion, ROM) was performed at baseline and after 3 months of specific kinetic rehabilitation program. Change in clinical parameters and TM3 index was reported, p<0.05. over 45% TMJ involvement at baseline as defined by TMJ index (mean value of 13.56) and only 36.66% at 3 months (p<0.05). Significant improvement in pain (presence, severity) was demonstrated at 3 moths (p<0.05): 18.05% spontaneous pain, 75.9% provoked pain, with 12.11% respectively 2.41% decreased in nocturnal respectively diurnal pain. Significant decrease (p<0.05) in joint noises at movements: 27.71% when opening and 12.04% when closing the mouth, 8.43 at protrusion and 3.61% at retraction, while 18% at the side movements. Complex accurate kinetic reeducation is mandatory for achieving correct posture (head, neck and trunk), normal mastication, swallowing and respiration, as well as correction of neuromuscular imbalances in patients with TMJD secondary to rheumatic disorders.

[Skills lab training in veterinary medicine. Effective preparation for clinical work at the small animal clinic of the University for Veterinary Medicine Hannover, Foundation].

PubMed

Engelskirchen, Simon; Ehlers, Jan; Kirk, Ansgar T; Tipold, Andrea; Dilly, Marc

2017-09-20

During five and a half years of studying veterinary medicine, students should in addition to theoretical knowledge acquire sufficient practical skills. Considering animal welfare and ethical aspects, opportunities for hands-on learning on living animals are limited because of the high annual number of students. The first German veterinary clinical-skills lab, established in 2013 at the University for Veterinary Medicine Hannover, Foundation (TiHo), offers opportunities for all students to learn, train and repeat clinical skills on simulators and models as frequently as they would like, until they feel sufficiently confident to transfer these skills to living animals. This study describes the establishment of clinical-skills lab training within the students' practical education, using the example of the small-animal clinic of the TiHo. Two groups of students were compared: without skills lab training (control group K) and with skills lab training (intervention group I). At the end of both the training and a subsequent 10-week clinical rotation in different sections of the clinic, an objective structured clinical examination (OSCE) was performed, testing the students' practical skills at 15 stations. An additional multiple-choice test was performed before and after the clinical rotation to evaluate the increased theoretical knowledge. Students of group I achieved significantly (p ≤ 0.05) better results in eight of the 15 tested skills. The multiple-choice test revealed a significant (p ≤ 0.05) gain of theoretical knowledge in both groups without any differences between the groups. Students displayed a high degree of acceptance of the skills lab training. Using simulators and models in veterinary education is an efficient teaching concept, and should be used continually and integrated in the curriculum.

Effect of a Game-Based Intervention Designed to Enhance Social Incentives to Increase Physical Activity Among Families: The BE FIT Randomized Clinical Trial.

PubMed

Patel, Mitesh S; Benjamin, Emelia J; Volpp, Kevin G; Fox, Caroline S; Small, Dylan S; Massaro, Joseph M; Lee, Jane J; Hilbert, Victoria; Valentino, Maureen; Taylor, Devon H; Manders, Emily S; Mutalik, Karen; Zhu, Jingsan; Wang, Wenli; Murabito, Joanne M

2017-11-01

Gamification, the application of game design elements such as points and levels in nongame contexts, is often used in digital health interventions, but evidence on its effectiveness is limited. To test the effectiveness of a gamification intervention designed using insights from behavioral economics to enhance social incentives within families to increase physical activity. The Behavioral Economics Framingham Incentive Trial (BE FIT) was a randomized clinical trial with a 12-week intervention period and a 12-week follow-up period. The investigation was a community-based study between December 7, 2015, and August 14, 2016. Participants in the modified intent-to-treat analysis were adults enrolled in the Framingham Heart Study, a long-standing cohort of families. All participants tracked daily step counts using a wearable device or a smartphone, established a baseline, selected a step goal increase, and received daily individual feedback on goal performance by text message or email for 24 weeks. Families in the gamification arm could earn points and progress through levels based on physical activity goal achievement during the 12-week intervention. The game design was meant to enhance collaboration, accountability, and peer support. The primary outcome was the proportion of participant-days that step goals were achieved during the intervention period. Secondary outcomes included the proportion of participant-days that step goals were achieved during the follow-up period and the change in the mean daily steps during the intervention and follow-up periods. Among 200 adults comprising 94 families, the mean age was 55.4 years, and 56.0% (n = 112) were female. During the intervention period, participants in the gamification arm achieved step goals on a significantly greater proportion of participant-days (0.53 vs 0.32; adjusted difference, 0.27; 95% CI, 0.20-0.33; P < .001) and had a significantly greater increase in the mean daily steps compared with baseline (1661 vs 636; adjusted difference, 953; 95% CI, 505-1401; P < .001) than the control arm. During the follow-up period, physical activity in the gamification arm declined but remained significantly greater than that in the control arm for the proportion of participant-days achieving step goals (0.44 vs 0.33; adjusted difference, 0.12; 95% CI, 0.05-0.19; P < .001) and the mean daily steps compared with baseline (1385 vs 798; adjusted difference, 494; 95% CI, 170-818; P < .01). Gamification designed to leverage insights from behavioral economics to enhance social incentives significantly increased physical activity among families in the community. clinicaltrials.gov Identifier: NCT02531763.

Portal pressure and liver stiffness measurements in the prediction of fibrosis regression after sustained virological response in recurrent hepatitis C.

PubMed

Mauro, Ezequiel; Crespo, Gonzalo; Montironi, Carla; Londoño, Maria-Carlota; Hernández-Gea, Virginia; Ruiz, Pablo; Sastre, Lydia; Lombardo, Julissa; Mariño, Zoe; Díaz, Alba; Colmenero, Jordi; Rimola, Antoni; Garcia-Pagán, Juan Carlos; Brunet, Mercé; Forns, Xavier; Navasa, Miquel

2018-05-01

Sustained virological response (SVR) improves survival in post-liver transplant (LT) recurrent hepatitis C. However, the impact of SVR on fibrosis regression is not well defined. In addition, the performance of noninvasive methods to evaluate the presence of fibrosis and portal hypertension (PH) post-SVR has been scarcely evaluated. We aimed to investigate the degree of fibrosis regression (decrease ≥1 METAVIR stage) after-SVR and its associated factors in recurrent hepatitis C, as well as the diagnostic capacity of noninvasive methods in the assessment of liver fibrosis and PH after viral clearance. We evaluated 112 hepatitis C virus-infected LT recipients who achieved SVR between 2001 and 2015. A liver biopsy was performed before treatment and 12 months post-SVR. Hepatic venous pressure gradient (HVPG), liver stiffness measurement (LSM), and Enhanced Liver Fibrosis (ELF) score were also determined at the same time points. Sixty-seven percent of the cohort presented fibrosis regression: 43% in recipients with cirrhosis and 72%-85% in the remaining stages (P = 0.002). HVPG, LSM, and ELF significantly decreased post-SVR. Liver function significantly improved, and survival was significantly better in patients achieving fibrosis regression. Baseline HVPG and LSM as well as decompensations before therapy were independent predictors of fibrosis regression. One year post-SVR, LSM had a high diagnostic accuracy to discard the presence of advanced fibrosis (AF) and clinically significant PH (AUROC, 0.902 and 0.888). In conclusion, SVR post-LT induces fibrosis regression in most patients, leading to significant clinical benefits. Pretreatment HVPG and LSM are significant determinants of the likelihood of fibrosis regression. Finally, LSM accurately predicts the presence of AF and PH 1 year after SVR and thus can be used to determine monitoring strategies. (Hepatology 2018;67:1683-1694). © 2017 by the American Association for the Study of Liver Diseases.

Reverse time-dependent effect of alphafetoprotein and disease control on survival of patients with Barcelona Clinic Liver Cancer stage C hepatocellular carcinoma.

PubMed

Ponziani, Francesca Romana; Spinelli, Irene; Rinninella, Emanuele; Cerrito, Lucia; Saviano, Antonio; Avolio, Alfonso Wolfango; Basso, Michele; Miele, Luca; Riccardi, Laura; Zocco, Maria Assunta; Annicchiarico, Brigida Eleonora; Garcovich, Matteo; Biolato, Marco; Marrone, Giuseppe; De Gaetano, Anna Maria; Iezzi, Roberto; Giuliante, Felice; Vecchio, Fabio Maria; Agnes, Salvatore; Addolorato, Giovanni; Siciliano, Massimo; Rapaccini, Gian Lodovico; Grieco, Antonio; Gasbarrini, Antonio; Pompili, Maurizio

2017-12-28

To characterize the survival of cirrhotic patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) and to ascertain the factors predicting the achievement of disease control (DC). The cirrhotic patients with BCLC stage C HCC evaluated by the Hepatocatt multidisciplinary group were subjected to the investigation. Demographic, clinical and tumor features, along with the best tumor response and overall survival were recorded. One hundred and ten BCLC stage C patients were included in the analysis; the median overall survival was 13.4 mo (95%CI: 10.6-17.0). Only alphafetoprotein (AFP) serum level > 200 ng/mL and DC could independently predict survival but in a time dependent manner, the former was significantly associated with increased risk of mortality within the first 6 mo of follow-up (HR = 5.073, 95%CI: 2.159-11.916, P = 0.0002), whereas the latter showed a protective effect against death after one year (HR = 0.110, 95%CI: 0.038-0.314, P < 0.0001). Only patients showing microvascular invasion and/or extrahepatic spread recorded lower chances of achieving DC (OR = 0.263, 95%CI: 0.111-0.622, P = 0.002). The BCLC stage C HCC includes a wide heterogeneous group of cirrhotic patients suitable for potentially curative treatments. The reverse and time dependent effect of AFP serum level and DC on patients' survival confers them as useful predictive tools for treatment management and clinical decisions.

Clinical and radiological outcomes of surgical treatment for symptomatic arachnoid cysts in adults.

PubMed

Wang, Yongqian; Wang, Fei; Yu, Mingkun; Wang, Weiping

2015-09-01

We retrospectively analyzed 63 patients (31 males and 32 females) with arachnoid cysts managed over a 15 year period at our institution. Surgical indications and modalities for the treatment of intracranial arachnoid cysts are controversial, although endoscopic fenestration is often recommended as a standard procedure. In our cohort, clinical postoperative results and radiological assessments based on the presenting symptoms, cyst location, cyst volume and surgical modalities were recorded. The most common symptoms included headaches (66.7%), dizziness (46%) and seizures (36.5%). Cyst wall excision with microsurgical craniotomy was carried out in 28 patients (44.4%), cyst fenestration in 16 (25.4%), cystoperitoneal or ventriculoperitoneal shunting in 15 (23.8%) and endoscopic fenestration in four patients (6.3%). A satisfactory clinical outcome was achieved in 51 patients (80.9%) and cyst reduction was achieved in 49 (77.8%), at the last follow-up. Clinical improvement correlated significantly with volume reduction in patients with suprasellar and infratentorial cysts (r=0.495; p=0.022) while a similar result was not found after surgery in patients with frontal and temporal cysts. Surgical complications were not correlated with surgical modalities, occurring in only seven patients (11.1%). The various surgical modalities did not influence outcomes. Patients with nonspecific symptoms such as headache may obtain favourable outcomes from surgical treatment with no severe complications, although, intracranial hypertension and neurological deficits are more definite surgical indications for arachnoid cysts. Copyright © 2015 Elsevier Ltd. All rights reserved.

A clinical audit cycle of post-operative hypothermia in dogs.

PubMed

Rose, N; Kwong, G P S; Pang, D S J

2016-09-01

Use of clinical audits to assess and improve perioperative hypothermia management in client-owned dogs. Two clinical audits were performed. In Audit 1 data were collected to determine the incidence and duration of perioperative hypothermia (defined as rectal temperatures <37·0°C). The results from Audit 1 were used to reach consensus on changes to be implemented to improve temperature management, including re-defining hypothermia as rectal temperature <37·5°C. Audit 2 was performed after 1 month with changes in place. Audit 1 revealed a high incidence of post-operative hypothermia (88·0%) and prolonged time periods (7·5 hours) to reach normothermia. Consensus changes were to use a forced air warmer on all dogs and measure rectal temperatures hourly post-operatively until temperature ≥37·5°C. After 1 month with the implemented changes, Audit 2 identified a significant reduction in the time to achieve a rectal temperature of ≥37·5°C, with 75% of dogs achieving this goal by 3·5 hours. The incidence of hypothermia at tracheal extubation remained high in Audit 2 (97·3% with a rectal temperature <37·5°C). Post-operative hypothermia was improved through simple changes in practice, showing that clinical audit is a useful tool for monitoring post-operative hypothermia and improving patient care. Overall management of perioperative hypothermia could be further improved with earlier intervention. © 2016 British Small Animal Veterinary Association.

Factors Predicting a Good Symptomatic Outcome After Prostate Artery Embolisation (PAE).

PubMed

Maclean, D; Harris, M; Drake, T; Maher, B; Modi, S; Dyer, J; Somani, B; Hacking, N; Bryant, T

2018-02-26

As prostate artery embolisation (PAE) becomes an established treatment for benign prostatic obstruction, factors predicting good symptomatic outcome remain unclear. Pre-embolisation prostate size as a predictor is controversial with a handful of papers coming to conflicting conclusions. We aimed to investigate if an association existed in our patient cohort between prostate size and clinical benefit, in addition to evaluating percentage volume reduction as a predictor of symptomatic outcome following PAE. Prospective follow-up of 86 PAE patients at a single institution between June 2012 and January 2016 was conducted (mean age 64.9 years, range 54-80 years). Multiple linear regression analysis was performed to assess strength of association between clinical improvement (change in IPSS) and other variables, of any statistical correlation, through Pearson's bivariate analysis. No major procedural complications were identified and clinical success was achieved in 72.1% (n = 62) at 12 months. Initial prostate size and percentage reduction were found to have a significant association with clinical improvement. Multiple linear regression analysis (r 2  = 0.48) demonstrated that percentage volume reduction at 3 months (r = 0.68, p < 0.001) had the strongest correlation with good symptomatic improvement at 12 months after adjusting for confounding factors. Both the initial prostate size and percentage volume reduction at 3 months predict good symptomatic outcome at 12 months. These findings therefore aid patient selection and counselling to achieve optimal outcomes for men undergoing prostate artery embolisation.

BIOCHEMICAL CONTROL DURING LONG-TERM FOLLOW-UP OF 230 ADULT PATIENTS WITH CUSHING DISEASE: A MULTICENTER RETROSPECTIVE STUDY.

PubMed

Geer, Eliza B; Shafiq, Ismat; Gordon, Murray B; Bonert, Vivien; Ayala, Alejandro; Swerdloff, Ronald S; Katznelson, Laurence; Lalazar, Yelena; Manuylova, Ekaterina; Pulaski-Liebert, Karen J; Carmichael, John D; Hannoush, Zeina; Surampudi, Vijaya; Broder, Michael S; Cherepanov, Dasha; Eagan, Marianne; Lee, Jackie; Said, Qayyim; Neary, Maureen P; Biller, Beverly M K

2017-08-01

Cushing disease (CD) results from excessive exposure to glucocorticoids caused by an adrenocorticotropic hormone-secreting pituitary tumor. Inadequately treated CD is associated with significant morbidity and elevated mortality. Multicenter data on CD patients treated in routine clinical practice are needed to assess treatment outcomes in this rare disorder. The study purpose was to describe the burden of illness and treatment outcomes for CD patients. Eight pituitary centers in four U.S. regions participated in this multicenter retrospective chart review study. Subjects were CD patients diagnosed at ≥18 years of age within the past 20 years. Descriptive statistical analyses were conducted to examine presenting signs, symptoms, comorbidities, and treatment outcomes. Of 230 patients, 79% were female (median age at diagnosis, 39 years; range, 18 to 78 years). Length of follow-up was 0 to 27.5 years (median, 1.9 years). Pituitary adenomas were 0 to 51 mm. The most common presenting comorbidities included hypertension (67.3%), polycystic ovary syndrome (43.5%), and hyperlipidemia (41.5%). Biochemical control was achieved with initial pituitary surgery in 41.4% patients (91 of 220), not achieved in 50.0% of patients (110 of 220), and undetermined in 8.6% of patients (19 of 220). At the end of follow-up, control had been achieved with a variety of treatment methods in 49.1% of patients (110 of 224), not achieved in 29.9% of patients (67 of 224), and undetermined in 21.0% of patients (47 of 224). Despite multiple treatments, at the end of follow-up, biochemical control was still not achieved in up to 30% of patients. These multicenter data demonstrate that in routine clinical practice, initial and long-term control is not achieved in a substantial number of patients with CD. BLA = bilateral adrenalectomy CD = Cushing disease CS = Cushing syndrome eCRF = electronic case report form MRI = magnetic resonance imaging PCOS = polycystic ovary syndrome.

Evaluation of an artificial intelligence guided inverse planning system: clinical case study.

PubMed

Yan, Hui; Yin, Fang-Fang; Willett, Christopher

2007-04-01

An artificial intelligence (AI) guided method for parameter adjustment of inverse planning was implemented on a commercial inverse treatment planning system. For evaluation purpose, four typical clinical cases were tested and the results from both plans achieved by automated and manual methods were compared. The procedure of parameter adjustment mainly consists of three major loops. Each loop is in charge of modifying parameters of one category, which is carried out by a specially customized fuzzy inference system. A physician prescribed multiple constraints for a selected volume were adopted to account for the tradeoff between prescription dose to the PTV and dose-volume constraints for critical organs. The searching process for an optimal parameter combination began with the first constraint, and proceeds to the next until a plan with acceptable dose was achieved. The initial setup of the plan parameters was the same for each case and was adjusted independently by both manual and automated methods. After the parameters of one category were updated, the intensity maps of all fields were re-optimized and the plan dose was subsequently re-calculated. When final plan arrived, the dose statistics were calculated from both plans and compared. For planned target volume (PTV), the dose for 95% volume is up to 10% higher in plans using the automated method than those using the manual method. For critical organs, an average decrease of the plan dose was achieved. However, the automated method cannot improve the plan dose for some critical organs due to limitations of the inference rules currently employed. For normal tissue, there was no significant difference between plan doses achieved by either automated or manual method. With the application of AI-guided method, the basic parameter adjustment task can be accomplished automatically and a comparable plan dose was achieved in comparison with that achieved by the manual method. Future improvements to incorporate case-specific inference rules are essential to fully automate the inverse planning process.

Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection.

PubMed

Lin, Ming V; Sise, Meghan E; Pavlakis, Martha; Amundsen, Beth M; Chute, Donald; Rutherford, Anna E; Chung, Raymond T; Curry, Michael P; Hanifi, Jasmine M; Gabardi, Steve; Chandraker, Anil; Heher, Eliot C; Elias, Nahel; Riella, Leonardo V

2016-01-01

The prevalence of Hepatitis C Virus (HCV) infection is significantly higher in patients with end-stage renal disease compared to the general population and poses important clinical challenges in patients who undergo kidney transplantation. Historically, interferon-based treatment options have been limited by low rates of efficacy and significant side effects, including risk of precipitating rejection. Limited data exist on the use of all-oral, interferon-free direct-acting antiviral (DAA) therapies in kidney transplant recipients. In this study, we performed a retrospective chart review with prospective clinical follow-up of post-kidney transplant patients treated with DAA therapies at three major hospitals in Boston, MA. A total of 24 kidney recipients with HCV infection received all-oral DAA therapy post-transplant. Patients were predominantly male (79%) with a median age of 60 years (range 34-70 years), median creatinine of 1.2 mg/dL (0.66-1.76), and 42% had advanced fibrosis or cirrhosis. The majority had HCV genotype 1a infection (58%). All patients received full-dose sofosbuvir; it was paired with simeprevir (9 patients without and 3 patients with ribavirin), ledipasvir (7 patients without and 1 patient with ribavirin) or ribavirin alone (4 patients). The overall sustained virologic response (SVR12) was 91% (21 out of 23 patients). One patient achieved SVR4 but demised prior to SVR12 check point due to treatment unrelated cause. Two treatment failures were successfully retreated with alternative DAA regimens and achieved SVR. Both initials failures occurred in patients with advanced fibrosis or cirrhosis, with genotype 1a infection, and prior HCV treatment failure. Adverse events were reported in 11 patients (46%) and were managed clinically without discontinuation of therapy. Calcineurin inhibitor trough levels did not significantly change during therapy. In this multi-center series of patients, all-oral DAA therapy appears to be safe and effective in post-kidney transplant patients with chronic HCV infection.

Efficacy and Safety of Direct Acting Antivirals in Kidney Transplant Recipients with Chronic Hepatitis C Virus Infection

PubMed Central

Lin, Ming V.; Sise, Meghan E.; Pavlakis, Martha; Amundsen, Beth M.; Chute, Donald; Rutherford, Anna E.; Chung, Raymond T.; Curry, Michael P.; Hanifi, Jasmine M.; Gabardi, Steve; Chandraker, Anil; Heher, Eliot C.; Elias, Nahel; Riella, Leonardo V.

2016-01-01

The prevalence of Hepatitis C Virus (HCV) infection is significantly higher in patients with end-stage renal disease compared to the general population and poses important clinical challenges in patients who undergo kidney transplantation. Historically, interferon-based treatment options have been limited by low rates of efficacy and significant side effects, including risk of precipitating rejection. Limited data exist on the use of all-oral, interferon-free direct-acting antiviral (DAA) therapies in kidney transplant recipients. In this study, we performed a retrospective chart review with prospective clinical follow-up of post-kidney transplant patients treated with DAA therapies at three major hospitals in Boston, MA. A total of 24 kidney recipients with HCV infection received all-oral DAA therapy post-transplant. Patients were predominantly male (79%) with a median age of 60 years (range 34–70 years), median creatinine of 1.2 mg/dL (0.66–1.76), and 42% had advanced fibrosis or cirrhosis. The majority had HCV genotype 1a infection (58%). All patients received full-dose sofosbuvir; it was paired with simeprevir (9 patients without and 3 patients with ribavirin), ledipasvir (7 patients without and 1 patient with ribavirin) or ribavirin alone (4 patients). The overall sustained virologic response (SVR12) was 91% (21 out of 23 patients). One patient achieved SVR4 but demised prior to SVR12 check point due to treatment unrelated cause. Two treatment failures were successfully retreated with alternative DAA regimens and achieved SVR. Both initials failures occurred in patients with advanced fibrosis or cirrhosis, with genotype 1a infection, and prior HCV treatment failure. Adverse events were reported in 11 patients (46%) and were managed clinically without discontinuation of therapy. Calcineurin inhibitor trough levels did not significantly change during therapy. In this multi-center series of patients, all-oral DAA therapy appears to be safe and effective in post-kidney transplant patients with chronic HCV infection. PMID:27415632

Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

PubMed

Pokhis, Karina; Bitterlich, Norman; Cornelli, Umberto; Cassano, Giuseppina

2015-01-01

The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo. 115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an increased daily physical activity (7 MET-h/week). They were randomized to receive standard treatment plus placebo (ST + PL) or standard treatment plus polyglucosamine (ST + PG), respectively. Participants were instructed to take 2 × 2 tablets before the two meals containing the highest fat content for at least 24 weeks. Body weight, BMI, waist circumference and the time needed for a 5 % body weight reduction (5R) were taken as main variables. The average weight loss over a period of 25 weeks in the ITT population was 5.8 ± 4.09 kg in the ST + PG group versus 4.0 ± 2.94 kg in the ST + PL (pU = 0.023; pt = 0.010). After 25 weeks, 34 participants achieved 5R in the ST + PG group (64.1 %) compared to only 23 participants in the ST + PL group (42.6 %) (ITT) (p Fisher = 0.033). Weight loss through hypo-caloric diets have been found to be effective. The additional effect of PG in combination with standard treatment is able to produce significantly better weight loss than placebo. Participants treated with ST + PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST + PL. Trial Registration at ClinicalTrials.gov: NCT02410785 Registered 07 April 2015.

Planning oral health and clinical discharge in primary care: the comprehensive dental care protocol outcome.

PubMed

Cavalcanti, Yuri Wanderley; Dantas de Almeida, Leopoldina de Fátima; Barbosa, Ailma de Souza; Nascimento Padilha, Wilton Wilney

2015-03-01

The dental care must be driven by preventive and curative measures that can contribute to the population's oral health promotion. To evaluate the impact of the actions proposed by a comprehensive dental care protocol (CDCP) on the oral health condition of primary care users. The sample consisted of 32 volunteers, assisted throughout the six phases proposed by the CDCP: diagnosis of dental needs; resolution of urgencies; restorative interventions; application of promotional measures; evaluation of the achieved health level; and periodic controls. Data were collected through clinical exams, which measured the simplified oral hygiene index (OHI-S), gingival bleeding index (GBI) and the decayed, missing and filled teeth (DMFT) Index, before and after the CDCP was implemented. Statistical analysis consisted of the Wilcoxon test, at 5% significance level (α = 0.05). The OHI-S and GBI indices showed a significant reduction (p < 0.05) from the initial (1.4 ± 0.6 and 46.3 ± 19.9) to final condition (0.9 ± 0.3 and 21.5 ± 7.5). The decayed, missing and filled teeth and the missing teeth component were not significantly altered (p > 0.05), showing final values equal to 12.7 ± 9.6 and 5.6 ± 7.8, respectively. Decayed elements were fully converted into filled elements, and the final values of the decayed and filled elements were, respectively, 0.0 ± 0.0 and 7.3 ± 5.7 (p < 0.05). The enactment of the CDCP had a beneficial effect on the oral health of the population assisted by the dental services offered in primary care and this protocol seems to ft the public dental service demands. The CDCP can be useful to public dental service planning since it showed an efficient clinical outcome to the patients. We consider that this protocol should be employed in primary care oral health services in order to achieve overall upgrade, access enlargement and public oral health promotion.

A bio-inspired swellable microneedle adhesive for mechanical interlocking with tissue

NASA Astrophysics Data System (ADS)

Yang, Seung Yun; O'Cearbhaill, Eoin D.; Sisk, Geoffroy C.; Park, Kyeng Min; Cho, Woo Kyung; Villiger, Martin; Bouma, Brett E.; Pomahac, Bohdan; Karp, Jeffrey M.

2013-04-01

Achieving significant adhesion to soft tissues while minimizing tissue damage poses a considerable clinical challenge. Chemical-based adhesives require tissue-specific reactive chemistry, typically inducing a significant inflammatory response. Staples are fraught with limitations including high-localized tissue stress and increased risk of infection, and nerve and blood vessel damage. Here inspired by the endoparasite Pomphorhynchus laevis, which swells its proboscis to attach to its host’s intestinal wall, we have developed a biphasic microneedle array that mechanically interlocks with tissue through swellable microneedle tips, achieving ~3.5-fold increase in adhesion strength compared with staples in skin graft fixation, and removal force of ~4.5 N cm-2 from intestinal mucosal tissue. Comprising a poly(styrene)-block-poly(acrylic acid) swellable tip and non-swellable polystyrene core, conical microneedles penetrate tissue with minimal insertion force and depth, yet high adhesion strength in their swollen state. Uniquely, this design provides universal soft tissue adhesion with minimal damage, less traumatic removal, reduced risk of infection and delivery of bioactive therapeutics.

Cognitive behaviour therapy for specific phobia of vomiting (Emetophobia): A pilot randomized controlled trial.

PubMed

Riddle-Walker, Lori; Veale, David; Chapman, Cynthia; Ogle, Frank; Rosko, Donna; Najmi, Sadia; Walker, Lana M; Maceachern, Pete; Hicks, Thomas

2016-10-01

This is the first randomised controlled trial to evaluate a protocol for cognitive behaviour therapy (CBT) for a Specific Phobia of Vomiting (SPOV) compared with a wait list and to use assessment scales that are specific for a SPOV. 24 participants (23 women and 1 man) were randomly allocated to either 12 sessions of CBT or a wait list. At the end of the treatment, CBT was significantly more efficacious than the wait list with a large effect size (Cohen's d=1.53) on the Specific Phobia of Vomiting Inventory between the two groups after 12 sessions. Six (50%) of the participants receiving CBT achieved clinically significant change compared to 2 (16%) participants in the wait list group. Eight (58.3%) participants receiving CBT achieved reliable improvement compared to 2 (16%) participants in the wait list group. A SPOV is a condition treatable by CBT but further developments are required to increase efficacy. Copyright © 2016 Elsevier Ltd. All rights reserved.

Will health fund rationalisation lead to significant premium reductions?

PubMed

Hanning, Brian

2003-01-01

It has been suggested that rationalisation of health funds will generate significant albeit unquantified cost savings and thus hold or reduce health fund premiums. 2001-2 Private Health Industry Administration Council (PHIAC) data has been used to analyse these suggestions. Payments by funds for clinical services will not vary after fund rationalisation. The savings after rationalisation will arise from reductions in management expenses, which form 10.9% of total fund expenditure. A number of rationalisation scenarios are considered. The highest theoretical industry wide saving found in any plausible scenario is 2.5%, and it is uncertain whether this level of saving could be achieved in practice. If a one off saving of this order were achieved, it would have no medium and long term impact on fund premiums increases given funds are facing cost increases of 4% to 5% per annum due to demographic changes and age standardised utilization increases. It is suggested discussions on fund amalgamation divert attention from the major factors increasing fund costs, which are substantially beyond fund control.

Incidence and prognosis of nosocomial infection after recovering of cardiac arrest in children.

PubMed

Fernández, Andrés; Solís, Ana; Cañete, Paloma; Del Castillo, Jimena; Urbano, Javier; Carrillo, Angel; López-Herce, Jesús

2017-04-01

to analyze the incidence of infection in children who have suffered an in-hospital cardiac arrest (CA) and the association with mortality. A retrospective unicenter observational study on a prospective database with children between one month and 16 years old, who have suffered an in-hospital CA was performed. Clinical, analytical and monitorization data, treatment, mortality and cause of death were recorded. 57 children were studied (57.6% males). Recovery of spontaneous circulation (ROSC) was achieved in 50 children (87.7%) and 32 (59.3%) survived. After ROSC, 28 patients (56% of those who achieved ROSC) were diagnosed of infection. There were not significant differences in mortality between patients infected (42.9%) and uninfected (27.3%) p=0.374. Only one died in consequence of a sepsis with multiorganic failure. The frequency of infection in children after recovering of a cardiac arrest is high. There were no statistically significant differences in mortality between patients with and without infection after ROSC. Copyright © 2017 Elsevier B.V. All rights reserved.

A Bio-Inspired Swellable Microneedle Adhesive for Mechanical Interlocking with Tissue

PubMed Central

Yang, Seung Yun; O'Cearbhaill, Eoin D.; Sisk, Geoffroy C.; Park, Kyeng Min; Cho, Woo Kyung; Villiger, Martin; Bouma, Brett E.; Pomahac, Bohdan; Karp, Jeffrey M.

2013-01-01

Achieving significant adhesion to soft tissues while minimizing tissue damage poses a considerable clinical challenge. Chemical-based adhesives require tissue-specific reactive chemistry, typically inducing a significant inflammatory response. Staples are fraught with limitations including high-localized tissue stress and increased risk of infection, and nerve and blood vessel damage. Here, inspired by the endoparasite Pomphorhynchus laevis which swells its proboscis to attach to its host’s intestinal wall, we have developed a biphasic microneedle array that mechanically interlocks with tissue through swellable microneedle tips, achieving ~ 3.5 fold increase in adhesion strength compared to staples in skin graft fixation, and removal force of ~ 4.5 N/cm2 from intestinal mucosal tissue. Comprising a poly(styrene)-block-poly(acrylic acid) swellable tip and non-swellable polystyrene core, conical microneedles penetrate tissue with minimal insertion force and depth, yet high adhesion strength in their swollen state. Uniquely, this design provides universal soft tissue adhesion with minimal damage, less traumatic removal, reduced risk of infection and delivery of bioactive therapeutics. PMID:23591869

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs

PubMed Central

Kalra, Dipak; Kobayashi, Shinji

2013-01-01

Objectives The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. Methods Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. Results The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. Conclusions Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes. PMID:24523993

Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network.

PubMed

Hien, Denise A; Jiang, Huiping; Campbell, Aimee N C; Hu, Mei-Chen; Miele, Gloria M; Cohen, Lisa R; Brigham, Gregory S; Capstick, Carrie; Kulaga, Agatha; Robinson, James; Suarez-Morales, Lourdes; Nunes, Edward V

2010-01-01

The purpose of the analysis was to examine the temporal course of improvement in symptoms of posttraumatic stress disorder (PTSD) and substance use disorder among women in outpatient substance abuse treatment. Participants were 353 women randomly assigned to 12 sessions of either trauma-focused or health education group treatment. PTSD and substance use assessments were conducted during treatment and posttreatment at 1 week and after 3, 6, and 12 months. A continuous Markov model was fit on four defined response categories (nonresponse, substance use response, PTSD response, or global response [improvement in both PTSD and substance use]) to investigate the temporal association between improvement in PTSD and substance use symptom severity during the study's treatment phase. A generalized linear model was applied to test this relationship over the follow-up period. Subjects exhibiting nonresponse, substance use response, or global response tended to maintain original classification; subjects exhibiting PTSD response were significantly more likely to transition to global response over time, indicating maintained PTSD improvement was associated with subsequent substance use improvement. Trauma-focused treatment was significantly more effective than health education in achieving substance use improvement, but only among those who were heavy substance users at baseline and had achieved significant PTSD reductions. PTSD severity reductions were more likely to be associated with substance use improvement, with minimal evidence of substance use symptom reduction improving PTSD symptoms. Results support the self-medication model of coping with PTSD symptoms and an empirical basis for integrated interventions for improved substance use outcomes in patients with severe symptoms.