Supporting the patient's role in guideline compliance: a controlled study.

PubMed

Rosenberg, Stephen N; Shnaiden, Tatiana L; Wegh, Arnold A; Juster, Iver A

2008-11-01

Clinical messages alerting physicians to gaps in the care of specific patients have been shown to increase compliance with evidence-based guidelines. This study sought to measure any additional impact on compliance when alerting messages also were sent to patients. For alerts that were generated by computerized clinical rules applied to claims, compliance was determined by subsequent claims evidence (eg, that recommended tests were performed). Compliance was measured in the baseline year and the study year for 4 study group employers (combined membership >100,000) that chose to add patient messaging in the study year, and 28 similar control group employers (combined membership >700,000) that maintained physician messaging but did not add patient messaging. The impact of patient messaging was assessed by comparing changes in compliance from baseline to study year in the 2 groups. Multiple logistic regression was used to control for differences between the groups. Because a given member or physician could receive multiple alerts, generalized estimating equations with clustering by patient and physician were used. Controlling for differences in age, sex, and the severity and types of clinical alerts between the study and control groups, the addition of patient messaging increased compliance by 12.5% (P <.001). This increase was primarily because of improved responses to alerts regarding the need for screening, diagnostic, and monitoring tests. Supplementing clinical alerts to physicians with messages directly to their patients produced a statistically significant increase in compliance with the evidence-based guidelines underlying the alerts.

Attitudes toward placebo-controlled clinical trials among depressed patients in Japan.

PubMed

Sugawara, Norio; Ishioka, Masamichi; Tsuchimine, Shoko; Tsuruga, Koji; Sato, Yasushi; Tarakita, Natsumi; Furukori, Hanako; Kudo, Shuhei; Tomita, Tetsu; Nakagami, Taku; Yasui-Furukori, Norio

2018-01-01

Placebo-controlled clinical trials are the standard in the design of clinical studies for the licensing of new drugs. Medical and ethical concerns regarding placebo use still exist in clinical trials of depressed patients. The aim of this study was to investigate the attitudes toward placebo-controlled clinical trials and to assess factors related to the willingness to participate in such trials among depressed patients in Japan. A total of 206 depressed patients aged 49.5 ± 15.7 years (mean ± SD) who were admitted to three psychiatric hospitals were recruited for a cross-sectional study from June 2015 to March 2016. After a thorough explanation of the placebo, the study participants completed a brief 14-item questionnaire developed to evaluate patients' attitudes regarding possible participation in placebo-controlled clinical trials. The Quick Inventory of Depressive Symptomatology was also administered to assess depressive symptoms. The results indicated that 47% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for the improvement of disease, desire to receive more medical care, encouragement by family or friends, and desire to support the development of new drugs were associated with the willingness to participate in such trials, whereas a belief that additional time would be required for medical examinations and fear of exacerbation of symptoms due to placebo use were associated with non-participation. Patients were asked about possible participation in placebo-controlled clinical trials. Less than half of the respondents were willing to participate in placebo-controlled clinical trials. Attitudes toward participation in a placebo-controlled clinical trial need to be considered when deciding whether to conduct such a trial. Copyright © 2017. Published by Elsevier B.V.

Adjunctive Effects of A Piscean Collagen-Based Controlled-Release Chlorhexidine Chip in the Treatment of Chronic Periodontitis: A Clinical and Microbiological Study

PubMed Central

John, Priya; Lazarus, Flemingson; Selvam, Arul; Prabhuji, Munivenkatappa Lakshmaiah Venkatesh

2015-01-01

Introduction PerioChip a bovine origin gelatine based CHX chip has shown beneficial effects in the management of Chronic Periodontitis. A new fish collagen based CHX chip similar to PerioChip is currently available; however this product has not been thoroughly researched. Aim The aim of the present study was to evaluate the effectiveness of a new Piscean collagen-based controlled-release chlorhexidine chip (CHX chip) as an adjunctive therapy to scaling and root planing (SRP). Settings and Design The study was conducted as a randomised, split-mouth, controlled clinical trial at Krishnadevaraya College of Dental Sciences, Bangalore, India. Materials and Methods In a split–mouth study involving 20 sites in 10 patients with chronic periodontitis, control sites received scaling and root planing and test sites received scaling and root planing (SRP) and the intrapocket CHX chip placement as an adjunct. Subgingival plaque samples were collected from both control and test sites at baseline, 11 days and 11 weeks and the anaerobic colony count were assessed. Clinical parameters that were recorded at baseline and 11 weeks were gingival index, Plaque index, Probing pocket depth (PPD), and Clinical attachment level (CAL). Plaque index was recorded additionally at 11 days. Results In the test group there was a statistically significant reduction in the total anaerobic colony count, gingival index and plaque scores from baseline as compared to control sites at all time intervals. An additional 0.8mm reduction in mean probing pocket depth was noted in the test group. Gain in Clinical attachment level was comparable in both groups. Conclusion The adjunctive use of the new collagen-based CHX chip yielded significant antimicrobial benefit accompanied by a reduction in probing depth and a clinical attachment level gain as compared to SRP alone. This suggests that it may be a useful treatment option of nonsurgical periodontal treatment of chronic periodontitis. PMID:26155567

Sustained impact of a short small group course with systematic feedback in addition to regular clinical clerkship activities on musculoskeletal examination skills--a controlled study.

PubMed

Perrig, Martin; Berendonk, Christoph; Rogausch, Anja; Beyeler, Christine

2016-01-28

The discrepancy between the extensive impact of musculoskeletal complaints and the common deficiencies in musculoskeletal examination skills lead to increased emphasis on structured teaching and assessment. However, studies of single interventions are scarce and little is known about the time-dependent effect of assisted learning in addition to a standard curriculum. We therefore evaluated the immediate and long-term impact of a small group course on musculoskeletal examination skills. All 48 Year 4 medical students of a 6 year curriculum, attending their 8 week clerkship of internal medicine at one University department in Berne, participated in this controlled study. Twenty-seven students were assigned to the intervention of a 6×1 h practical course (4-7 students, interactive hands-on examination of real patients; systematic, detailed feedback to each student by teacher, peers and patients). Twenty-one students took part in the regular clerkship activities only and served as controls. In all students clinical skills (CS, 9 items) were assessed in an Objective Structured Clinical Examination (OSCE) station, including specific musculoskeletal examination skills (MSES, 7 items) and interpersonal skills (IPS, 2 items). Two raters assessed the skills on a 4-point Likert scale at the beginning (T0), the end (T1) and 4-12 months after (T2) the clerkship. Statistical analyses included Friedman test, Wilcoxon rank sum test and Mann-Whitney U test. At T0 there were no significant differences between the intervention and control group. At T1 and T2 the control group showed no significant changes of CS, MSES and IPS compared to T0. In contrast, the intervention group significantly improved CS, MSES and IPS at T1 (p < 0.001). This enhancement was sustained for CS and MSES (p < 0.05), but not for IPS at T2. Year 4 medical students were incapable of improving their musculoskeletal examination skills during regular clinical clerkship activities. However, an additional small group, interactive clinical skills course with feedback from various sources, improved these essential examination skills immediately after the teaching and several months later. We conclude that supplementary specific teaching activities are needed. Even a single, short-lasting targeted module can have a long lasting effect and is worth the additional effort.

Does specific psychopathology predict development of psychosis in ultra high-risk (UHR) patients?

PubMed

Thompson, Andrew; Nelson, Barnaby; Bruxner, Annie; O'Connor, Karen; Mossaheb, Nilufar; Simmons, Magenta B; Yung, Alison

2013-04-01

Studies have attempted to identify additional risk factors within the group identified as 'ultra high risk' (UHR) for developing psychotic disorders in order to characterise those at highest risk. However, these studies have often neglected clinical symptom types as additional risk factors. We aimed to investigate the relationship between baseline clinical psychotic or psychotic-like symptoms and the subsequent transition to a psychotic disorder in a UHR sample. A retrospective 'case-control' methodology was used. We identified all individuals from a UHR clinic who had subsequently developed a psychotic disorder (cases) and compared these to a random sample of individuals from the clinic who did not become psychotic within the sampling time frame (controls). The sample consisted of 120 patients (60 cases, 60 controls). An audit tool was used to identify clinical symptoms reported at entry to the clinic (baseline) using the clinical file. Diagnosis at transition was assessed using the Operational Criteria for Psychotic Illness (OPCRIT) computer program. The relationship between transition to a psychotic disorder and baseline symptoms was explored using survival analysis. Presence of thought disorder, any delusions and elevated mood significantly predicted transition to a psychotic disorder. When other symptoms were adjusted for, only the presence of elevated mood significantly predicted subsequent transition (hazard ratio 2.69, p = 0.002). Thought disorder was a predictor of transition to a schizophrenia-like psychotic disorder (hazard ratio 3.69, p = 0.008). Few individual clinical symptoms appear to be predictive of transition to a psychotic disorder in the UHR group. Clinicians should be cautious about the use of clinical profile alone in such individuals when determining who is at highest risk.

Empagliflozin/linagliptin single-pill combination therapy for patients with type 2 diabetes mellitus.

PubMed

Jain, Rajeev Kumar

2017-04-01

Type 2 diabetes mellitus (T2DM) is typically progressive, with sequential addition of therapies often needed to address increasing hyperglycemia over the disease course. Using treatments in combination may be preferred to sequential addition, as a means of providing a more rapid clinical response and potentially avoiding clinical inertia. In such cases, a single-pill combination can help to reduce pill burden. Although various single-pill combinations of oral glucose-lowering agents are available, empagliflozin/linagliptin was the first approved combination of a sodium glucose co-transporter 2 (SGLT2) inhibitor with a dipeptidyl peptidase 4 (DPP-4) inhibitor in the United States. Areas covered: Two publications of the clinical trial investigating the efficacy and safety of single-pill combinations of empagliflozin/linagliptin in treatment-naive or metformin-treated patients with T2DM (NCT01422876) are reviewed, and their potential impact on clinical practice is discussed. Expert opinion: The study discussed provides evidence for the efficacy and safety of empagliflozin/linagliptin single pills. Addition of an empagliflozin/linagliptin single pill may be considered in patients with inadequate glycemic control on metformin, or as an alternative to first-line treatment with empagliflozin or linagliptin when metformin is not suitable, particularly in patients with very poor glycemic control, or those who need to achieve target more quickly.

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

PubMed

El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

2016-10-27

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

Role of re-screening of cervical smears in internal quality control.

PubMed Central

Baker, A; Melcher, D; Smith, R

1995-01-01

AIMS--To investigate the use of rapid re-screening as a quality control method for previously screened cervical slides; to compare this method with 10% random re-screening and clinically indicated double screening. METHODS--Between June 1990 and December 1994, 117,890 negative smears were subjected to rapid re-screening. RESULTS--This study shows that rapid re-screening detects far greater numbers of false negative cases when compared with both 10% random re-screening and clinically indicated double screening, with no additional demand on human resources. The technique also identifies variation in the performance of screening personnel as an additional benefit. CONCLUSION--Rapid re-screening is an effective method of quality control. Although less sensitive, rapid re-screening should replace 10% random re-screening and selected re-screening as greater numbers of false negative results are detected while consuming less resources. PMID:8543619

Using the implicit relational assessment procedure to compare implicit pro-thin/anti-fat attitudes of patients with anorexia nervosa and non-clinical controls.

PubMed

Parling, Thomas; Cernvall, Martin; Stewart, Ian; Barnes-Holmes, Dermot; Ghaderi, Ata

2012-01-01

Implicit pro-thin/anti-fat attitudes were investigated among a mixed group of patients with full and sub-threshold Anorexia Nervosa (n = 17), and a matched-age control group (n = 17). The Implicit Relational Assessment Procedure (IRAP) was employed to measure implicit pro-thin and anti-fat attitudes towards Self and Others in addition to "striving for thinness" and "avoidance of fatness." The clinical group showed an implicit pro-fat attitude towards Others and stronger anti-fat attitudes towards Self and avoidance of fatness compared with controls. The findings are discussed in relation to the over-evaluation of weight and shape in the clinical group.

BioMEMS for multiparameter clinical monitoring

NASA Astrophysics Data System (ADS)

Moser, Isabella

2003-01-01

For diabetes patients glucose monitoring means an important improvement of their life quality and additionally it is a $3-billion-a-year business. Continuous glucose monitoring provides gapless glucose level control, an early warning of hypoglycemia, and is intended to control insulin pumps. An upgrading to multi-parameter monitoring would not only benefit patients with severe metabolism defects but also the metabolism of diabetes patient could be better controlled by monitoring an additional parameter like lactate. Multi-parameter monitoring devices are not commercially available, one of the complications in the integration of different biosensors using the same detecting molecule for all analytes is chemical cross talk between adjacent amperometric biosensors. Recently some integrated biosensors were published but either they were not mass producible or they were realized in an expensive silicon based technology. In addition to it most of them were not tested under monitoring conditions but their integration principles will be discussed. As an example a low cost multi- parameter microsystem and some applications of it in clinical diagnosis will be presented. Also an overlook of non-invasive methods and (minimal) invasive methods will be given with a focus on microdialysis.

Mitochondrial Respiration in Human Colorectal and Breast Cancer Clinical Material Is Regulated Differently

PubMed Central

Koit, Andre; Ounpuu, Lyudmila; Klepinin, Aleksandr; Chekulayev, Vladimir; Timohhina, Natalja; Tepp, Kersti; Puurand, Marju; Truu, Laura; Heck, Karoliina; Valvere, Vahur; Guzun, Rita

2017-01-01

We conducted quantitative cellular respiration analysis on samples taken from human breast cancer (HBC) and human colorectal cancer (HCC) patients. Respiratory capacity is not lost as a result of tumor formation and even though, functionally, complex I in HCC was found to be suppressed, it was not evident on the protein level. Additionally, metabolic control analysis was used to quantify the role of components of mitochondrial interactosome. The main rate-controlling steps in HBC are complex IV and adenine nucleotide transporter, but in HCC, complexes I and III. Our kinetic measurements confirmed previous studies that respiratory chain complexes I and III in HBC and HCC can be assembled into supercomplexes with a possible partial addition from the complex IV pool. Therefore, the kinetic method can be a useful addition in studying supercomplexes in cell lines or human samples. In addition, when results from culture cells were compared to those from clinical samples, clear differences were present, but we also detected two different types of mitochondria within clinical HBC samples, possibly linked to two-compartment metabolism. Taken together, our data show that mitochondrial respiration and regulation of mitochondrial membrane permeability have substantial differences between these two cancer types when compared to each other to their adjacent healthy tissue or to respective cell cultures. PMID:28781720

Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care.

PubMed

Francis, Nick A; Ridd, Matthew J; Thomas-Jones, Emma; Butler, Christopher C; Hood, Kerenza; Shepherd, Victoria; Marwick, Charis A; Huang, Chao; Longo, Mirella; Wootton, Mandy; Sullivan, Frank

2017-03-01

Eczema may flare because of bacterial infection, but evidence supporting antibiotic treatment is of low quality. We aimed to determine the effect of oral and topical antibiotics in addition to topical emollient and corticosteroids in children with clinically infected eczema. We employed a 3-arm, blinded, randomized controlled trial in UK ambulatory care. Children with clinical, non-severely infected eczema were randomized to receive oral and topical placebos (control), oral antibiotic (flucloxacillin) and topical placebo, or topical antibiotic (fusidic acid) and oral placebo, for 1 week. We compared Patient Oriented Eczema Measure (POEM) scores at 2 weeks using analysis of covariance (ANCOVA). We randomized 113 children (40 to control, 36 to oral antibiotic, and 37 to topical antibiotic). Mean (SD) baseline Patient Oriented Eczema Measure scores were 13.4 (5.1) for the control group, 14.6 (5.3) for the oral antibiotic group, and 16.9 (5.5) for the topical antibiotic group. At baseline, 104 children (93%) had 1 or more of the following findings: weeping, crusting, pustules, or painful skin. Mean (SD) POEM scores at 2 weeks were 6.2 (6.0) for control, 8.3 (7.3) for the oral antibiotic group, and 9.3 (6.2) for the topical antibiotic group. Controlling for baseline POEM score, neither oral nor topical antibiotics produced a significant difference in mean (95% CI) POEM scores (1.5 [-1.4 to 4.4] and 1.5 [-1.6 to 4.5] respectively). There were no significant differences in adverse effects and no serious adverse events. We found rapid resolution in response to topical steroid and emollient treatment and ruled out a clinically meaningful benefit from the addition of either oral or topical antibiotics. Children seen in ambulatory care with mild clinically infected eczema do not need treatment with antibiotics. © 2017 Annals of Family Medicine, Inc.

Succinate-based preparation alleviates manifestations of the climacteric syndrome in women.

PubMed

Peskov, A B; Maevskii, E I; Uchitel', M L; Sakharova, N Yu; Vize-Khripunova, M A

2005-09-01

Clinical placebo-controlled study of Enerlit-Clima (bioactive succinate-based food additive) a showed positive effect of the preparation on general clinical and psychoemotional manifestations of the climacteric syndrome. A trend to an increase in estradiol level in early pathological climacteric and normalization of the endometrial status were observed.

(Short overview of the Mexican Society of Clinical Chemistry meetings)

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

Burtis, C.

1991-01-01

Organized and chaired session on instrument evaluation at the XIV Congreso Nacional De Quimica Clinica which is the National Meeting of the Mexican Society of Clinical Chemistry. In addition, I presented a paper on calibration at a Congress workshop and spoke on the impact of technology in a symposium on quality control.

Association between glioma and history of allergies, asthma, and eczema: a case-control study with three groups of controls

PubMed Central

Il’yasova, Dora; McCarthy, Bridget; Marcello, Jennifer; Schildkraut, Joellen M.; Moorman, Patricia G.; Krishnamachari, Bhuma; Ali-Osman, Francis; Bigner, Darell D.; Davis, Faith

2009-01-01

Because glioma etiology is largely unknown, the inverse association of glioma risk with atopic conditions is promising and deserves close scrutiny. We examined the association between a history of allergies, asthma, and eczema and glioma risk using sibling, friend, and clinic-based controls. This analysis included 388 incident glioma cases and 80 sibling, 191 friend, and 177 clinic-based controls. Each subject’s medical history was assessed via a web-based or telephone survey. Odds ratios (ORs) and their 95% confidence intervals for the associations with allergies, asthma, eczema, and the overall number of these conditions were calculated from conditional (for sibling and friend controls) and unconditional (for clinic-based controls) logistic models. Allergies were consistently inversely associated with the glioma: ORs were 0.53 (95% CI, 0.15–1.84), 0.54 (95% CI, 0.28–1.07), and 0.34 (95% CI, 0.23–0.50) with sibling, friend, and clinic-based controls, respectively. Asthma showed an inverse association only in the comparison with sibling controls (OR=0.43; 95% CI, 0.19–1.00). Eczema showed an inverse association only in the comparison with friend controls (OR=0.42; 95% CI, 0.15–1.18). The overall number of these conditions (ordinal score 0, 1, 2, 3) was inversely associated with glioma: The risk decreased 31–45% with each addition of an atopic condition. These estimates were the most stable when different control groups were considered. Comparing the prevalence of these conditions in the three control groups with published data, we note that clinic-based controls generally better approximate the prevalence data for population-based groups. These controls appear to present a reasonable choice for clinic-centered case-control studies. PMID:19336556

Mitochondrial dysfunction in myocardium obtained from clinically normal dogs, clinically normal anesthetized dogs, and dogs with dilated cardiomyopathy.

PubMed

Sleeper, Meg M; Rosato, Bradley P; Bansal, Seema; Avadhani, Narayan G

2012-11-01

To compare mitochondrial complex I and complex IV activity in myocardial mitochondria of clinically normal dogs, clinically normal dogs exposed to inhalation anesthesia, and dogs affected with dilated cardiomyopathy. Myocardial samples obtained from 21 euthanized dogs (6 clinically normal [control] dogs, 5 clinically normal dogs subjected to inhalation anesthesia with isoflurane prior to euthanasia, 5 dogs with juvenile-onset dilated cardiomyopathy, and 5 dogs with adult-onset dilated cardiomyopathy). Activity of mitochondrial complex I and complex IV was assayed spectrophotometrically in isolated mitochondria from left ventricular tissue obtained from the 4 groups of dogs. Activity of complex I and complex IV was significantly decreased in anesthetized dogs, compared with activities in the control dogs and dogs with juvenile-onset or adult-onset dilated cardiomyopathy. Inhalation anesthesia disrupted the electron transport chain in the dogs, which potentially led to an outburst of reactive oxygen species that caused mitochondrial dysfunction. Inhalation anesthesia depressed mitochondrial function in dogs, similar to results reported in other species. This effect is important to consider when anesthetizing animals with myocardial disease and suggested that antioxidant treatments may be beneficial in some animals. Additionally, this effect should be considered when designing studies in which mitochondrial enzyme activity will be measured. Additional studies that include a larger number of animals are warranted.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

PubMed Central

2010-01-01

Background Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. Discussion This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Clinical trial registration number Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 PMID:21073703

[Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

PubMed

Inagaki, Osamu

2016-04-01

Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

Can corneal pannus with trachomatous inflammation--follicular be used in combination as an improved specific clinical sign for current ocular Chlamydia trachomatis infection?

PubMed

Derrick, Tamsyn; Holland, Martin J; Cassama, Eunice; Markham-David, Rod; Nabicassa, Meno; Marks, Michael; Bailey, Robin L; Last, Anna R

2016-01-27

Trachoma is a blinding disease caused by conjunctival infection with Chlamydia trachomatis (Ct). Mass drug administration (MDA) for trachoma control is administered based on the population prevalence of the clinical sign of trachomatis inflammation - follicular (TF). However, the prevalence of TF is often much higher than the prevalence of Ct infection. The addition of a clinical sign specific for current ocular Ct infection to TF could save resources by preventing unnecessary additional rounds of MDA. Study participants were aged between 1-9 years and resided on 7 islands of the Bijagos Archipelago, Guinea Bissau. Clinical grades for trachoma and corneal pannus and ocular swab samples were taken from 80 children with TF and from 81 matched controls without clinical evidence of trachoma. Ct infection testing was performed using droplet digital PCR. New pannus was significantly associated with Ct infection after adjustment for TF (P = 0.009, OR = 3.65 (1.4-9.8)). Amongst individuals with TF, individuals with new pannus had significantly more Ct infection than individuals with none or old pannus (75.0% vs 45.5%, Chi(2) P = 0.01). TF and new pannus together provide a highly specific (91.7%), but a poorly sensitive (51.9%) clinical diagnostic test for Ct infection. As we move towards trachoma elimination it may be desirable to use a combined clinical sign (new pannus in addition to TF) that is highly specific for current ocular Ct infection. This would allow national health systems to obtain a more accurate estimate of Ct population prevalence to inform further need for MDA without the expense of Ct molecular diagnostics, which are currently unaffordable in programmatic contexts.

Heart failure disease management: implementation and outcomes.

PubMed

Whellan, David J

2005-01-01

Millions of dollars are being spent to identify new therapies to improve mortality and morbidity for the growing epidemic of patients sustaining heart failure. However, in clinical practice, these therapies are currently underused. To bridge the gap between proven therapies and clinical practice, the medical community has turned to disease management. Heart failure disease management interventions vary from vital-sign monitoring to multidisciplinary approaches involving a pharmacist, nutritionist, nurse practitioner, and physician. This review attempts to categorize these inventions based on location. We compared the published results from randomized, controlled trials of the following types of heart failure disease management interventions: inpatient, clinic visits, home visits, and telephone follow up. Although research shows an improvement in the quality of care and a decrease in hospitalizations for patients sustaining heart failure, the economic impact of disease management is still unclear. The current reimbursement structure is a disincentive to providers wanting to offer disease management services to patients sustaining heart failure. Additionally, the cost of providing disease management services such as additional clinical visits, patient education materials, or additional personnel time has not been well documented. Most heart failure disease management studies do confirm the concept that providing increased access to healthcare providers for an at-risk group of patients sustaining heart failure does improve outcomes. However, a large-scale randomized, controlled clinical trial based in the United States is needed to prove that this concept can be implemented beyond a single center and to determine how much it will cost patients, providers, healthcare systems, and payers.

Integration of an Objective Structured Clinical Examination (OSCE) into the dental preliminary exams.

PubMed

Ratzmann, Anja; Wiesmann, Ulrich; Kordaß, Bernd

2012-01-01

In the pre-clinical phase of the study of dentistry at the University of Greifswald, the course "Early Patient Contact (EPC)" is conducted within the framework of Community Medicine/Dentistry. The course is based on three pillars: the patient visiting program, special problem-oriented seminars, and communication training for doctors. The essential goal consists of providing students with real patient contact right at the beginning of their study of dentistry, thus making the study of dentistry patient-based very early on. Students are trained in taking comprehensive anamneses and recording clinical findings. Within the framework of the dental preliminary exams, the course is evaluated using an OSCE on a standardized patient. Furthermore, the added value of an additional training unit (conducting anamnesis and clinical examination) in preparation for the OSCE was evaluated. The exam results of a group without training (control group) were compared with those of a group with training (intervention group). The intervention group performed significantly better than the control on the following items: the total number of points achieved on the OSCE early patient contact, and in the most important points of the anamnesis and clinical examination. In addition, the intervention group tended to score higher in terms of the item "oral health status". The present study showed a positive effect of an additional training unit on students' performance in the OSCE. Taking the limitations of the study and the results of a literature review into account, we recommend conducting such training as preparation for the OSCE.

Clinical follow-up after cessation of chronic electrical neuromodulation in patients with severe coronary artery disease: a prospective randomized controlled study on putative involvement of sympathetic activity.

PubMed

Jessurun, G A; DeJongste, M J; Hautvast, R W; Tio, R A; Brouwer, J; van Lelieveld, S; Crijns, H J

1999-10-01

The present study assessed the reoccurrence of myocardial ischemia after withholding electrical neurostimulation. After randomization, in the study or withdrawal group, spinal cord stimulation (SCS) was set active during the first 4 weeks, followed by 4 weeks of withholding stimulation. In the control group, SCS was switched off during 4 weeks before the end of the study. The control group had no crossover period. Measurements were done at baseline, then after 4 and 8 weeks. The first periods at 4 weeks of each sequence of both groups were compared. In addition, a comparison of clinical variables was performed between the study group 4 weeks after withholding stimulation and the control group 4 weeks following randomization. A total number of 24 patients with refractory angina and an implanted spinal cord stimulator were included in the study (n = 12) and control group. Angina pectoris complaints, nitroglycerin intake, ischemia, and heart rate variability using 48-hour ambulatory electrocardiographic monitoring were assessed. In addition, neurohormonal status and symptom-limited aerobic capacity were evaluated. There was no increase of anginal complaints or ischemia after withholding stimulation. Neurohormonal levels and aerobic capacity were not altered. We conclude that there is no adverse clinical rebound phenomenon after withholding neurostimulation in patients with refractory angina pectoris.

Hospital-Based Clinical Pharmacy Services to Improve Ambulatory Management of Chronic Obstructive Pulmonary Disease

PubMed Central

Smith, Amber Lanae; Palmer, Valerie; Farhat, Nada; Kalus, James S.; Thavarajah, Krishna; DiGiovine, Bruno; MacDonald, Nancy C.

2016-01-01

Background: No systematic evaluations of a comprehensive clinical pharmacy process measures currently exist to determine an optimal ambulatory care collaboration model for chronic obstructive pulmonary disease (COPD) patients. Objective: Describe the impact of a pharmacist-provided clinical COPD bundle on the management of COPD in a hospital-based ambulatory care clinic. Methods: This retrospective cohort analysis evaluated patients with COPD managed in an outpatient pulmonary clinic. The primary objective of this study was to assess the completion of 4 metrics known to improve the management of COPD: (1) medication therapy management, (2) quality measures including smoking cessation and vaccines, (3) patient adherence, and (4) patient education. The secondary objective was to evaluate the impact of the clinical COPD bundle on clinical and economic outcomes at 30 and 90 days post–initial visit. Results: A total of 138 patients were included in the study; 70 patients served as controls and 68 patients received the COPD bundle from the clinical pharmacist. No patients from the control group had all 4 metrics completed as documented, compared to 66 of the COPD bundle group (P < .0001). Additionally, a statistically significant difference was found in all 4 metrics when evaluated individually. Clinical pharmacy services reduced the number of phone call consults at 90 days (P = .04) but did not have a statistically significant impact on any additional pre-identified clinical outcomes. Conclusion: A pharmacist-driven clinical COPD bundle was associated with significant increases in the completion and documentation of 4 metrics known to improve the outpatient management of COPD.

Limited association between perceived control and health-related quality of life in patients with heart failure.

PubMed

Banerjee, Teesta; Lee, Kyoung Suk; Browning, Steven R; Hopenhayn, Claudia; Westneat, Susan; Biddle, Martha J; Arslanian-Engoren, Cynthia; Eastwood, Jo-Ann; Mudd, Gia; Moser, Debra K

2014-01-01

Perceived control has been suggested as a modifiable factor associated with health-related quality of life (HRQOL). However, the relationship between perceived control and HRQOL has not been evaluated in patients with heart failure (HF). The purpose of this study was to determine whether perceived control independently predicts HRQOL in HF patients. A total of 423 HF patients were included. Hierarchical linear regression was performed to determine the independent association of perceived control to HRQOL after controlling for covariates. Higher levels of perceived control were associated with better HRQOL in univariate analysis. However, this relationship was strongly attenuated after controlling for relevant demographic, clinical, and psychological factors; the variance in HRQOL explained by the addition of perceived control to this model was small (1.4%). We found only a weak relationship between perceived control and HRQOL when considered in the presence of demographic, clinical, and psychological factors.

Economic analysis of temperature-controlled laminar airflow (TLA) for the treatment of patients with severe persistent allergic asthma.

PubMed

Brazier, Peter; Schauer, Uwe; Hamelmann, Eckard; Holmes, Steve; Pritchard, Clive; Warner, John O

2016-01-01

Chronic asthma is a significant burden for individual sufferers, adversely impacting their quality of working and social life, as well as being a major cost to the National Health Service (NHS). Temperature-controlled laminar airflow (TLA) therapy provides asthma patients at BTS/SIGN step 4/5 an add-on treatment option that is non-invasive and has been shown in clinical studies to improve quality of life for patients with poorly controlled allergic asthma. The objective of this study was to quantify the cost-effectiveness of TLA (Airsonett AB) technology as an add-on to standard asthma management drug therapy in the UK. The main performance measure of interest is the incremental cost per quality-adjusted life year (QALY) for patients using TLA in addition to usual care versus usual care alone. The incremental cost of TLA use is based on an observational clinical study monitoring the incidence of exacerbations with treatment valued using NHS cost data. The clinical effectiveness, used to derive the incremental QALY data, is based on a randomised double-blind placebo-controlled clinical trial comprising participants with an equivalent asthma condition. For a clinical cohort of asthma patients as a whole, the incremental cost-effectiveness ratio (ICER) is £8998 per QALY gained, that is, within the £20 000/QALY cost-effectiveness benchmark used by the National Institute for Health and Care Excellence (NICE). Sensitivity analysis indicates that ICER values range from £18 883/QALY for the least severe patients through to TLA being dominant, that is, cost saving as well as improving quality of life, for individuals with the most severe and poorly controlled asthma. Based on our results, Airsonett TLA is a cost-effective addition to treatment options for stage 4/5 patients. For high-risk individuals with more severe and less well controlled asthma, the use of TLA therapy to reduce incidence of hospitalisation would be a cost saving to the NHS.

Impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes: Randomized controlled trial.

PubMed

Wishah, Ruba A; Al-Khawaldeh, Omar A; Albsoul, Abla M

2015-01-01

The primary aim of this study was to evaluate the impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes patients in Jordan. A randomized controlled clinical trial was conducted on 106 patients with uncontrolled type 2 diabetes seeking care in the diabetes clinics at Jordan University Hospital. Patients were randomly allocated into control and intervention group. The intervention group patients received pharmaceutical care interventions developed by the clinical pharmacist in collaboration with the physician while the control group patients received usual care without clinical pharmacist's input. Fasting blood glucose and HbA1c were measured at the baseline, at three months, and six months intervals for both intervention and control groups. After the six months follow-up, mean of HbA1c and FBS of the patients in the intervention group decreased significantly compared to the control group patients (P<0.05). Also, the results indicated that mean scores of patients' knowledge about medications, knowledge about diabetes and adherence to medications and diabetes self-care activities of the patients in the intervention group increased significantly compared to the control group (P<0.05). This study demonstrated an improvement in HbA1c, FBS, and lipid profile, in addition to self-reported medication adherence, diabetes knowledge, and diabetes self-care activities in patients with type 2 diabetes who received pharmaceutical care interventions. The results suggest the benefits of integrating clinical pharmacist services in multidisciplinary healthcare team and diabetes management in Jordan. Copyright © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

A hospital-wide clinical findings dictionary based on an extension of the International Classification of Diseases (ICD).

PubMed

Bréant, C; Borst, F; Campi, D; Griesser, V; Momjian, S

1999-01-01

The use of a controlled vocabulary set in a hospital-wide clinical information system is of crucial importance for many departmental database systems to communicate and exchange information. In the absence of an internationally recognized clinical controlled vocabulary set, a new extension of the International statistical Classification of Diseases (ICD) is proposed. It expands the scope of the standard ICD beyond diagnosis and procedures to clinical terminology. In addition, the common Clinical Findings Dictionary (CFD) further records the definition of clinical entities. The construction of the vocabulary set and the CFD is incremental and manual. Tools have been implemented to facilitate the tasks of defining/maintaining/publishing dictionary versions. The design of database applications in the integrated clinical information system is driven by the CFD which is part of the Medical Questionnaire Designer tool. Several integrated clinical database applications in the field of diabetes and neuro-surgery have been developed at the HUG.

A hospital-wide clinical findings dictionary based on an extension of the International Classification of Diseases (ICD).

PubMed Central

Bréant, C.; Borst, F.; Campi, D.; Griesser, V.; Momjian, S.

1999-01-01

The use of a controlled vocabulary set in a hospital-wide clinical information system is of crucial importance for many departmental database systems to communicate and exchange information. In the absence of an internationally recognized clinical controlled vocabulary set, a new extension of the International statistical Classification of Diseases (ICD) is proposed. It expands the scope of the standard ICD beyond diagnosis and procedures to clinical terminology. In addition, the common Clinical Findings Dictionary (CFD) further records the definition of clinical entities. The construction of the vocabulary set and the CFD is incremental and manual. Tools have been implemented to facilitate the tasks of defining/maintaining/publishing dictionary versions. The design of database applications in the integrated clinical information system is driven by the CFD which is part of the Medical Questionnaire Designer tool. Several integrated clinical database applications in the field of diabetes and neuro-surgery have been developed at the HUG. Images Figure 1 PMID:10566451

The positive effects of different platelet-rich plasma methods on human muscle, bone, and tendon cells.

PubMed

Mazzocca, Augustus D; McCarthy, Mary Beth R; Chowaniec, David M; Dugdale, Evan M; Hansen, Derek; Cote, Mark P; Bradley, James P; Romeo, Anthony A; Arciero, Robert A; Beitzel, Knut

2012-08-01

Clinical application of platelet-rich plasma (PRP) in the realm of orthopaedic sports medicine has yielded variable results. Differences in separation methods and variability of the individual may contribute to these variable results. To compare the effects of different PRP separation methods on human bone, muscle, and tendon cells in an in vitro model. Controlled laboratory study. Blood collected from 8 participants (mean ± SD age 31.6 ± 10.9 years) was used to obtain PRP preparations. Three different PRP separation methods were used: a single-spin process yielding a lower platelet concentration (PRP(LP)), a single-spin process yielding high platelet and white blood cell concentrations (PRP(HP)), and a double-spin that produces a higher platelet concentration and lower white blood cell concentration (PRP(DS)). Human bone, muscle, and tendon cells obtained from discarded tissue samples during shoulder surgery were placed into culture and treated with the 3 PRP preparations, control media (2% fetal bovine serum [FBS] and 10% FBS), and native blood. Radioactive thymidine assays were obtained to examine cell proliferation, and testing with enzyme-linked immunosorbent assay was used to determine growth factor concentrations. Addition of PRP(LP) to osteocytes, myocytes, and tenocytes significantly increased cell proliferation (P ≤ .05) compared with the controls. Adding PRP(DS) to osteoblasts and tenocytes increased cell proliferation significantly (P ≤ .05), but no significance was shown for its addition to myocytes. The addition of PRP(HP) significantly increased cell proliferation compared with the controls only when added to tenocytes (P ≤ .05). Osteoblasts: Proliferation was significantly increased by addition of PRP(LP) compared with all controls (2% FBS, 10% FBS, native blood) (P ≤ .05). Addition of PRP(DS) led to significantly increased proliferation compared with all controls, native blood, and PRP(HP) (P ≤ .05). Proliferation was significantly less when PRP(HP) was added compared with PRP(DS) (P ≤ .05). Myocytes: Proliferation was significantly increased by addition of PRP(LP) compared with native blood (P ≤ .05). Adding PRP(HP) or PRP(DS) to myocytes showed no significant increase in proliferation compared with the controls or the other separations. Tenocytes: Proliferation was significantly increased by addition of PRP(LP) compared with all controls (2% FBS, 10% FBS, native blood) (P ≤ .05). Addition of PRP(DS) showed a significant increase compared with the controls and native blood. For tenocytes, there was a significant increase (P ≤ .05) seen when PRP(HP) was added compared with the controls and native blood but not compared with the other separations. The primary findings of this study suggest the application of different PRP separations may result in a potential beneficial effect on the clinically relevant target cells in vitro. However, it is unclear which platelet concentration or PRP preparation may be optimal for the treatment of various cell types. In addition, a "more is better" theory for the use of higher platelet concentrations cannot be supported. This study was not intended to prove efficacy but to provide a platform for future research to be built upon. The utilization of different PRP separations may result in a potentially beneficial effect on the clinically relevant target cells in vitro, but it is unclear which platelet concentration or PRP preparation may be optimal for the treatment of various cell types.

Visual processing in Alzheimer's disease: surface detail and colour fail to aid object identification.

PubMed

Adlington, Rebecca L; Laws, Keith R; Gale, Tim M

2009-10-01

It has been suggested that object recognition in patients with Alzheimer's disease (AD) may be strongly influenced both by image format (e.g. colour vs. line-drawn) and by low-level visual impairments. To examine these notions, we tested basic visual functioning and picture naming in 41 AD patients and 40 healthy elderly controls. Picture naming was examined using 105 images representing a wide range of living and nonliving subcategories (from the Hatfield image test [HIT]: [Adlington, R. A., Laws, K. R., & Gale, T. M. (in press). The Hatfield image test (HIT): A new picture test and norms for experimental and clinical use. Journal of Clinical and Experimental Neuropsychology]), with each item presented in colour, greyscale, or line-drawn formats. Whilst naming for elderly controls improved linearly with the addition of surface detail and colour, AD patients showed no benefit from the addition of either surface information or colour. Additionally, controls showed a significant category by format interaction; however, the same profile did not emerge for AD patients. Finally, AD patients showed widespread and significant impairment on tasks of visual functioning, and low-level visual impairment was predictive of patient naming.

Impulsivity in borderline personality disorder: a matter of disturbed impulse control or a facet of emotional dysregulation?

PubMed

Sebastian, Alexandra; Jacob, Gitta; Lieb, Klaus; Tüscher, Oliver

2013-02-01

Impulsivity is regarded as a clinical, diagnostic and pathophysiological hallmark of borderline personality disorder (BPD). Self-report measures of impulsivity consistently support the notion of higher impulsive traits in BPD patients as compared to healthy control subjects. Laboratory tests of impulsivity, i.e. neuropsychological tests of impulse control render weak and inconsistent results both across different cognitive components of impulse control and within the same cognitive component of impulse control. One important factor worsening impulsive behaviors and impulse control deficits in BPD is comorbid attention-deficit/hyperactivity disorder (ADHD). In addition, emotional dysregulation interacts with impulse control especially for BPD salient emotions. In sum, although basic mechanisms of impulse control seem not to be disturbed in BPD, clinically well observed impulsive behaviors may be explained by comorbid ADHD or may be the consequence of dysregulation of BPD salient emotions.

[Teaching of clinical reasoning to medical students using prototypical clinical cases].

PubMed

Montaldo L, Gustavo; Herskovic L, Pedro

2013-07-01

Clinical reasoning is the most important competente in the training process of a physician. To develop a method for teaching clinical reasoning based on prototypes of clinical cases. The study was conducted on sixty-four third year medical students. The study and control groups attended lectures and tutorial sessions with patients. The study group attended additionally discussion seminars of prototypical clinical cases. A clinical reasoning test was applied at the start and end of the learning period to both groups. At the end of the study, the opinions of students of the study group were collected in a focus group. After the learning period, both groups significantly increased their clinical reasoning skills. However, the improvement in the study group was more than double than that of the control group. The absolute improvement in the study group was 30.9%. Students interviewed in the focus group were unanimous in expressing their satisfaction in each and every aspect discussed. The teaching of clinical reasoning to third year medical students by means of pattern recognition in seminars with clinical cases improved significantly their skills.

Defining Polio: Closing the Gap in Global Surveillance.

PubMed

Tajaldin, Bachir; Almilaji, Khaled; Langton, Paul; Sparrow, Annie

2015-01-01

By late 2012 the Global Polio Eradication Initiative (GPEI) had nearly eradicated this ancient infectious disease. Successful surveillance programs for acute flaccid paralysis however rely on broad governmental support for implementation. With the onset of conflict, public health breakdown has contributed to the resurgence of polio in a number of regions. The current laboratory based case definition may be a contributory factor in these regions. We sought to compare case definition rates using strict laboratory based criteria to rates obtained using the clinical criteria in modern day Syria. We also sought to examine this distribution of cases by sub-region. We examined the World Health Organization (WHO) reported figures for Syria from 2013-2014 using laboratory based criteria. We compared these with cases obtained when clinical criteria were applied. In addition we sought data from the opposition controlled Assistance Coordination Unit which operates in non-Government controlled areas where WHO data maybe incomplete. Cases were carefully examined for potential overlap to avoid double reporting. Whilst the WHO data clearly confirmed the polio outbreak in Syria, it did so with considerable delay and with under reporting of cases, particularly from non-government controlled areas. In addition, laboratory based case definition led to a substantial underestimate of polio (36 cases) compared with those found with the clinically compatible definition (an additional 46 cases). Rates of adequate diagnostic specimens from suspected cases are well below target, no doubt reflecting the effect of conflict in these areas. We have identified a gap in the surveillance of polio, a global threat. The current laboratory based definition, in the setting of conflict and insecurity, leads to under diagnosis of polio with potential delays and inadequacies in coordinating effective responses to contain outbreaks and eradicate polio. Breakdown in public health measures as a contributing factor is likely to result in a resurgence of previously controlled infectious diseases. The clinical definition should be reinstituted to supplement the lab-based definition. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Coping with changing controlled vocabularies.

PubMed Central

Cimino, J. J.; Clayton, P. D.

1994-01-01

For the foreseeable future, controlled medical vocabularies will be in a constant state of development, expansion and refinement. Changes in controlled vocabularies must be reconciled with historical patient information which is coded using those vocabularies and stored in clinical databases. This paper explores the kinds of changes that can occur in controlled vocabularies, including adding terms (simple additions, refinements, redundancy and disambiguation), deleting terms, changing terms (major and minor name changes), and other special situations (obsolescence, discovering redundancy, and precoordination). Examples are drawn from actual changes appearing in the 1993 update to the International Classification of Diseases (ICD9-CM). The methods being used at Columbia-Presbyterian Medical Center to reconcile its Medical Entities Dictionary and its clinical database are discussed. PMID:7949906

Hypnosis for Acute Procedural Pain: A Critical Review.

PubMed

Kendrick, Cassie; Sliwinski, Jim; Yu, Yimin; Johnson, Aimee; Fisher, William; Kekecs, Zoltán; Elkins, Gary

2016-01-01

Clinical evidence for the effectiveness of hypnosis in the treatment of acute procedural pain was critically evaluated based on reports from randomized controlled clinical trials (RCTs). Results from the 29 RCTs meeting inclusion criteria suggest that hypnosis decreases pain compared to standard care and attention control groups and that it is at least as effective as comparable adjunct psychological or behavioral therapies. In addition, applying hypnosis in multiple sessions prior to the day of the procedure produced the highest percentage of significant results. Hypnosis was most effective in minor surgical procedures. However, interpretations are limited by considerable risk of bias. Further studies using minimally effective control conditions and systematic control of intervention dose and timing are required to strengthen conclusions.

HYPNOSIS FOR ACUTE PROCEDURAL PAIN: A Critical Review

PubMed Central

Kendrick, Cassie; Sliwinski, Jim; Yu, Yimin; Johnson, Aimee; Fisher, William; Kekecs, Zoltán; Elkins, Gary

2015-01-01

Clinical evidence for the effectiveness of hypnosis in the treatment of acute, procedural pain was critically evaluated based on reports from randomized controlled clinical trials (RCTs). Results from the 29 RCTs meeting inclusion criteria suggest that hypnosis decreases pain compared to standard care and attention control groups and that it is at least as effective as comparable adjunct psychological or behavioral therapies. In addition, applying hypnosis in multiple sessions prior to the day of the procedure produced the highest percentage of significant results. Hypnosis was most effective in minor surgical procedures. However, interpretations are limited by considerable risk of bias. Further studies using minimally effective control conditions and systematic control of intervention dose and timing are required to strengthen conclusions. PMID:26599994

Targeted temperature management in neurological intensive care unit

PubMed Central

Muengtaweepongsa, Sombat; Srivilaithon, Winchana

2017-01-01

Targeted temperature management (TTM) shows the most promising neuroprotective therapy against hypoxic/ischemic encephalopathy (HIE). In addition, TTM is also useful for treatment of elevated intracranial pressure (ICP). HIE and elevated ICP are common catastrophic conditions in patients admitted in Neurologic intensive care unit (ICU). The most common cause of HIE is cardiac arrest. Randomized control trials demonstrate clinical benefits of TTM in patients with post-cardiac arrest. Although clinical benefit of ICP control by TTM in some specific critical condition, for an example in traumatic brain injury, is still controversial, efficacy of ICP control by TTM is confirmed by both in vivo and in vitro studies. Several methods of TTM have been reported in the literature. TTM can apply to various clinical conditions associated with hypoxic/ischemic brain injury and elevated ICP in Neurologic ICU. PMID:28706860

Relative performance of soft contact lenses having lathe-cut posterior surfaces with and without additional polishing.

PubMed

O'Brien, C; Charman, W N

2006-05-01

After a preliminary investigation of the effects of tool feed rate and spindle speed on the surface roughness of unhydrated, lathe-cut polymacon surfaces, a laboratory and clinical comparison was made between lenses with identical parameters except that the lathe-cut posterior surface was left unpolished in the "test" lenses and was polished in the "control" lenses. The lenses had moulded anterior surfaces. Laboratory comparisons included surface roughness, lens power and its uniformity across the surface. Double-blind clinical trials over 4-hour (27 subjects) and 1-month (10 subjects) periods, involved one eye of each subject wearing a "test" lens and the other, a "control" lens. No clinically significant differences were found between the results for the test and control lenses. It is concluded that today's lathing technology makes a final polishing stage unnecessary.

Effects of controlled-release formulations of atypical antipsychotics on functioning and quality of life of schizophrenic individuals.

PubMed

Ruiu, Stefania; Casu, Maria Antonietta; Casu, Gianluca; Piras, Sara; Marchese, Giorgio

2012-08-01

Controlled-release formulations of atypical antipsychotics have recently been introduced into clinical practice. Clinical studies have indicated that these new therapies induce meaningful improvements in the functioning and quality of life of schizophrenic individuals. The present analysis makes an attempt to address the clinical relevance of these studies and their contribution to the understanding of the mechanisms of action of these new drugs. A Medline search was done using the keywords 'antipsychotic', 'plasma level', 'quality of life' and 'functioning'. After reviewing the literature, it seems that symptom control and side effects may play a role in modulating the functioning and quality of life of schizophrenic individuals treated with controlled-release formulations of atypical antipsychotics. The analysis also highlights that these new drugs may possess peculiarities and similarities in regulating patient functioning. However, the low number of clinical analyses that have focused on these aspects of antipsychotic therapy limits the interpretation of the results. Additional comparative clinical trials are needed to evaluate how the pharmacokinetic/pharmacodynamic properties of antipsychotic drugs may modulate the functioning and quality of life of schizophrenic individuals, as well as to establish whether new clinical benefits may come from the use of these drugs in schizophrenia therapy.

Food-additive-induced urticaria: a survey of 838 patients with recurrent chronic idiopathic urticaria.

PubMed

Di Lorenzo, Gabriele; Pacor, Maria Luisa; Mansueto, Pasquale; Martinelli, Nicola; Esposito-Pellitteri, Maria; Lo Bianco, Claudia; Ditta, Vito; Leto-Barone, Maria Stefania; Napoli, Nicola; Di Fede, Gaetana; Rini, Giovambattista; Corrocher, Roberto

2005-11-01

Recurrent chronic idiopathic urticaria (RCIU) is a common skin condition that affects 0.1-3% of the population in the USA and Europe and accounts for nearly 75% of all 'ordinary' chronic urticaria (CU) cases. We studied 838 consecutive patients with RCIU referred to hospital between 1998 and 2003. Patients with known causes of CU were excluded. Clinical history, physical examination, and symptom diaries were evaluated during two periods, a diet-free period (1 week) and a food-additive-free diet (FAFD) period (4 weeks), respectively, and two double-blind placebo-controlled (DBPC) challenges of six food additives were administered. The first DBPC challenge included a mixture of the six food additives (DBPCmixed) given to all patients. The second DBPC challenge comprised the single food additives, administered at increasing doses (DBPCsingle) to patients with a positive DBPCmixed test and 105 patients with a negative DBPCmixed test, as a control. The DBPCmixed challenge was positive in 116 patients. None of the 105 control patients had a positive DBPCsingle test. Only 31 DBPCsingle tests were positive in patients with positive DBPCmixed challenge. Twenty-four of the 116 patients showing a positive DBPCmixed challenge also had a positive DBPCsingle result. Our results confirmed that food additive hypersensitivity reactions occurred in few RCIU patients using DBPCsingle challenge. The combination of the results of FAFD and DBPCmixed challenge seems to be of considerable practical interest for allergists, internists and dermatologists, rather than the data of clinical history and the results of DBPCsingle challenge, in patients with RCIU. Copyright (c) 2005 S. Karger AG, Basel.

Neurologic effects of exogenous saccharides: A review of controlled human, animal, and in vitro studies

PubMed Central

Nelson, Erika D.; Ramberg, Jane E.; Best, Talitha; Sinnott, Robert A.

2012-01-01

Objectives Current research efforts are centered on delineating the novel health benefits of naturally derived saccharides, including growing interest in their abilities to influence neurologic health. We performed a comprehensive review of the literature to consolidate all controlled studies assessing various roles of exogenous saccharide compounds and polysaccharide-rich extracts from plants, fungi, and other natural sources on brain function, with a significant focus on benefits derived from oral intake. Methods Studies were identified by conducting electronic searches on PubMed and Google Scholar. Reference lists of articles were also reviewed for additional relevant studies. Only articles published in English were included in this review. Results Six randomized, double-blind, placebo-controlled clinical studies were identified in which consumption of a blend of plant-derived polysaccharides showed positive effects on cognitive function and mood in healthy adults. A separate controlled clinical study observed improvements in well-being with ingestion of a yeast beta-glucan. Numerous animal and in vitro studies have demonstrated the ability of individual saccharide compounds and polysaccharide-rich extracts to modify behavior, enhance synaptic plasticity, and provide neuroprotective effects. Discussion Although the mechanisms by which exogenous saccharides can influence brain function are not well understood at this time, the literature suggests that certain naturally occurring compounds and polysaccharide-rich extracts show promise, when taken orally, in supporting neurologic health and function. Additional well-controlled clinical studies on larger populations are necessary, however, before specific recommendations can be made. PMID:22417773

Efficacy and safety of concurrent chemoradiation with weekly cisplatin ± low-dose celecoxib in locally advanced undifferentiated nasopharyngeal carcinoma: a phase II-III clinical trial.

PubMed

Mohammadianpanah, Mohammad; Razmjou-Ghalaei, Sasan; Shafizad, Amin; Ashouri-Taziani, Yaghoub; Khademi, Bijan; Ahmadloo, Niloofar; Ansari, Mansour; Omidvari, Shapour; Mosalaei, Ahmad; Mosleh-Shirazi, Mohammad Amin

2011-01-01

This is the first study that aimed to determine the efficacy and safety of concurrent chemoradiation with weekly cisplatin ± celecoxib 100 mg twice daily in locally advanced undifferentiated nasopharyngeal carcinoma. Eligible patients had newly diagnosed locally advanced (T3-T4, and/or N2-N3, M0) undifferentiated nasopharyngeal carcinoma, no prior therapy, Karnofsky performance status ≥ 70, and normal organ function. The patients were assigned to receive 7 weeks concurrent chemoradiation (70 Gy) with weekly cisplatin 30 mg/m 2 with either celecoxib 100 mg twice daily, (study group, n = 26) or placebo (control group, n = 27) followed by adjuvant combined chemotherapy with cisplatin 70 mg/m 2 on day 1 plus 5-fluorouracil 750 mg/m 2 /d with 8-h infusion on days 1-3, 3-weekly for 3 cycles. Overall clinical response rate was 100% in both groups. Complete and partial clinical response rates were 64% and 36% in the study group and 44% and 56% in the control group, respectively (P > 0.25). The addition of celecoxib to concurrent chemoradiation was associated with improved 2-year locoregional control rate from 84% to 100% (P = 0.039). The addition of celecoxib 100 mg twice daily to concurrent chemoradiation improved 2-year locoregional control rate.

Clinical profile of patients with type 2 diabetes mellitus treated with sodium- glucose cotransporter-2 inhibitors and experience in real-world clinical practice in Spain.

PubMed

Cuatrecasas, Gabriel; Goñi-Goicoechea, Fernando

2016-11-01

The main aim of the treatment of type 2 diabetes is overall control of cardiovascular risk factors. Almost 50% of patients with type 2 diabetes do not achieve glycaemic targets, and a much higher percentage do not achieve weight and blood pressure targets, despite the therapeutic arsenal that has appeared in the last decade for the treatment of this disease. In addition, antidiabetic secretatogues and insulin are associated with weight gain and an increased risk of hyperglycaemic episodes. Clinical practice guidelines recommend sodium-glucose cotransporter-2 inhibitors (SGLT2i) as an alternative in the same therapeutic step as the other options after initiation of metformin therapy. The present study reviews the most appropriate patient profile for SGLT2i therapy, based on their safety and efficacy demonstrated in controlled clinical trials. The article discusses which patients are at risk of experiencing the possible secondary effects due to the mechanism of action of this new therapeutic class, in whom SGLT2i should be used with caution. These considerations on the profile of patients suitable for SGLT2i therapy are contrasted with the results obtained in daily clinical practice, both in retrospective studies from other countries and from real-world experiences in Spain. This article presents a selection of studies performed in distinct centres with a minimum follow-up of 6 months and compares their results with those from clinical trials. SGLT2i are used in clinical practice in any therapeutic step and the efficacy results are very similar to those reported by controlled clinical trials, with a slightly higher proportion of genitourinary infections and a low dropout rate. Half the reported patients are diabetics receiving insulin therapy plus a gliflozin, showing the wide uptake of this therapeutic strategy by clinicians. SGLT2i are especially attractive due to their additional effectiveness in weight and blood pressure control and the possibility of using them in association with other antidiabetic agents or in monotherapy in patients at any stage of type 2 diabetes. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

76 FR 14688 - Importer of Controlled Substances; Notice of Application

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-17

... Concentrate (9670) II The company plans to import a finished pharmaceutical product containing cannabis extracts in dosage form for packaging for a clinical trial study. In addition, the company also plans to...

Attachment styles, memories of parental rearing and therapeutic bond: a study with eating disordered patients, their parents and therapists.

PubMed

Tereno, Susana; Soares, Isabel; Martins, Carla; Celani, Mariana; Sampaio, Daniel

2008-01-01

Patients diagnosed with anorexia nervosa (n = 30) and bulimia nervosa (n = 27), their parents and therapists were recruited for this study aimed at examining differences between clinical groups and a control group (n = 35) in terms of attachment styles and perceptions of memories of parental rearing. Within the clinical groups, relations among these variables and therapeutic bond were explored. In addition, parents' and their daughters' attachment styles were compared. The results showed differences between clinical and control groups: the daughters in the control group reported lower levels of attachment anxiety compared to those of the clinical groups; their mothers exhibited higher security than mothers of anorectic patients and lower avoidance than mothers of bulimic patients. For the anorectic group, therapeutic bond was associated to higher father's emotional support and lower rejection; in the bulimic group, therapeutic bond was related to higher maternal emotional support and lower rejection as well as to lower paternal overprotection.

High-Level Disinfection of Otorhinolaryngology Clinical Instruments: An Evaluation of the Efficacy and Cost-effectiveness of Instrument Storage.

PubMed

Yalamanchi, Pratyusha; Yu, Jason; Chandler, Laura; Mirza, Natasha

2018-01-01

Objectives Despite increasing interest in individual instrument storage, risk of bacterial cross-contamination of otorhinolaryngology clinic instruments has not been assessed. This study is the first to determine the clinical efficacy and cost-effectiveness of standard high-level disinfection and clinic instrument storage. Methods To assess for cross-contamination, surveillance cultures of otorhinolaryngology clinic instruments subject to standard high-level disinfection and storage were obtained at the start and end of the outpatient clinical workday. Rate of microorganism recovery was compared with cultures of instruments stored in individual peel packs and control cultures of contaminated instruments. Based on historical clinic data, the direct allocation method of cost accounting was used to determine aggregate raw material cost and additional labor hours required to process and restock peel-packed instruments. Results Among 150 cultures of standard high-level disinfected and co-located clinic instruments, 3 positive bacterial cultures occurred; 100% of control cultures were positive for bacterial species ( P < .001). There was no statistical difference between surveillance cultures obtained before and after the clinic day. While there was also no significant difference in rate of contamination between peel-packed and co-located instruments, peel packing all instruments requires 6250 additional labor hours, and conservative analyses place the cost of individual semicritical instrument storage at $97,852.50 per year. Discussion With in vitro inoculation of >200 otorhinolaryngology clinic instruments, this study demonstrates that standard high-level disinfection and storage are equally efficacious to more time-consuming and expensive individual instrument storage protocols, such as peel packing, with regard to bacterial contamination. Implications for Practice Standard high-level disinfection and storage are equally effective to labor-intensive and costly individual instrument storage protocols.

Factors influencing accuracy of cortical thickness in the diagnosis of Alzheimer's disease.

PubMed

Belathur Suresh, Mahanand; Fischl, Bruce; Salat, David H

2018-04-01

There is great value to use of structural neuroimaging in the assessment of Alzheimer's disease (AD). However, to date, predictive value of structural imaging tend to range between 80% and 90% in accuracy and it is unclear why this is the case given that structural imaging should parallel the pathologic processes of AD. There is a possibility that clinical misdiagnosis relative to the gold standard pathologic diagnosis and/or additional brain pathologies are confounding factors contributing to reduced structural imaging classification accuracy. We examined potential factors contributing to misclassification of individuals with clinically diagnosed AD purely from cortical thickness measures. Correctly classified and incorrectly classified groups were compared across a range of demographic, biological, and neuropsychological data including cerebrospinal fluid biomarkers, amyloid imaging, white matter hyperintensity (WMH) volume, cognitive, and genetic factors. Individual subject analyses suggested that at least a portion of the control individuals misclassified as AD from structural imaging additionally harbor substantial AD biomarker pathology and risk, yet are relatively resistant to cognitive symptoms, likely due to "cognitive reserve," and therefore clinically unimpaired. In contrast, certain clinical control individuals misclassified as AD from cortical thickness had increased WMH volume relative to other controls in the sample, suggesting that vascular conditions may contribute to classification accuracy from cortical thickness measures. These results provide examples of factors that contribute to the accuracy of structural imaging in predicting a clinical diagnosis of AD, and provide important information about considerations for future work aimed at optimizing structural based diagnostic classifiers for AD. © 2017 Wiley Periodicals, Inc.

Interidentity amnesia for neutral, episodic information in dissociative identity disorder.

PubMed

Huntjens, Rafaële J C; Postma, Albert; Peters, Madelon L; Woertman, Liesbeth; van der Hart, Onno

2003-05-01

Interidentity amnesia is considered a hallmark of dissociative identity disorder (DID) in clinical practice. In this study, objective methods of testing episodic memory transfer between identities were used. Tests of both recall (interference paradigm) and recognition were used. A sample of 31 DID patients was included. Additionally, 50 control subjects participated, half functioning as normal controls and the other half simulating interidentity amnesia. Twenty-one patients subjectively reported complete one-way amnesia for the learning episode. However, objectively, neither recall nor recognition scores of patients were different from those of normal controls. It is suggested that clinical models of amnesia in DID may be specified to exclude episodic memory impairments for emotionally neutral material.

The evaluation of clinical therapy effects of oral western medicine combined with magnetic pulse acupoint stimulation in treating elderly patients with coronary heart disease.

PubMed

Fu, Xin; Guo, Li; Jiang, Zheng-Ming; Xu, Ai-Guo

2015-01-01

Treat the patients suffered from coronary heart disease with oral western medicine, combining with magnetic pulse acupoint stimulation, and observe the therapeutic effects of such combination therapy method. 56 old people with coronary heart disease are randomly divided into a treatment group and a control group. Both groups of patients are treated by the routine drugs, in addition, the patients of the treatment group are treated by magnetic pulse therapy additionally. Compare clinical symptoms, blood lipid and blood rheological indexes of the patients in the two groups when they are selected and after 30 days' treatment. after 30 days' treatment, it is found that clinical symptoms, blood lipid and blood rheological indexes of the patients in the treatment group are significantly improved compared with those when they are selected and those of the control group (P<0.05). patients with coronary heart disease, treated by pulsed magnetic therapy and the conventional drug intervention, had relieved synptom, improve blood lipid and heart blood supply function.

The evaluation of clinical therapy effects of oral western medicine combined with magnetic pulse acupoint stimulation in treating elderly patients with coronary heart disease

PubMed Central

Fu, Xin; Guo, Li; Jiang, Zheng-Ming; Xu, Ai-Guo

2015-01-01

Objective: Treat the patients suffered from coronary heart disease with oral western medicine, combining with magnetic pulse acupoint stimulation, and observe the therapeutic effects of such combination therapy method. Methods: 56 old people with coronary heart disease are randomly divided into a treatment group and a control group. Both groups of patients are treated by the routine drugs, in addition, the patients of the treatment group are treated by magnetic pulse therapy additionally. Compare clinical symptoms, blood lipid and blood rheological indexes of the patients in the two groups when they are selected and after 30 days’ treatment. Results: after 30 days’ treatment, it is found that clinical symptoms, blood lipid and blood rheological indexes of the patients in the treatment group are significantly improved compared with those when they are selected and those of the control group (P<0.05). Conclusion: patients with coronary heart disease, treated by pulsed magnetic therapy and the conventional drug intervention, had relieved synptom, improve blood lipid and heart blood supply function. PMID:26309664

Cognitive behavioral therapy for schizophrenia: an empirical review.

PubMed

Rector, Neil A; Beck, Aaron T

2012-10-01

Early case studies and noncontrolled trial studies focusing on the treatment of delusions and hallucinations have laid the foundation for more recent developments in comprehensive cognitive behavioral therapy (CBT) interventions for schizophrenia. Seven randomized, controlled trial studies testing the efficacy of CBT for schizophrenia were identified by electronic search (MEDLINE and PsychInfo) and by personal correspondence. After a review of these studies, effect size (ES) estimates were computed to determine the statistical magnitude of clinical change in CBT and control treatment conditions. CBT has been shown to produce large clinical effects on measures of positive and negative symptoms of schizophrenia. Patients receiving routine care and adjunctive CBT have experienced additional benefits above and beyond the gains achieved with routine care and adjunctive supportive therapy. These results reveal promise for the role of CBT in the treatment of schizophrenia although additional research is required to test its efficacy, long-term durability, and impact on relapse rates and quality of life. Clinical refinements are needed also to help those who show only minimal benefit with the intervention.

Canadian Thoracic Society 2012 guideline update: Diagnosis and management of asthma in preschoolers, children and adults

PubMed Central

Lougheed, M Diane; Lemiere, Catherine; Ducharme, Francine M; Licskai, Chris; Dell, Sharon D; Rowe, Brian H; FitzGerald, Mark; Leigh, Richard; Watson, Wade; Boulet, Louis-Philippe

2012-01-01

BACKGROUND: In 2010, the Canadian Thoracic Society (CTS) published a Consensus Summary for the diagnosis and management of asthma in children six years of age and older, and adults, including an updated Asthma Management Continuum. The CTS Asthma Clinical Assembly subsequently began a formal clinical practice guideline update process, focusing, in this first iteration, on topics of controversy and/or gaps in the previous guidelines. METHODS: Four clinical questions were identified as a focus for the updated guideline: the role of noninvasive measurements of airway inflammation for the adjustment of anti-inflammatory therapy; the initiation of adjunct therapy to inhaled corticosteroids (ICS) for uncontrolled asthma; the role of a single inhaler of an ICS/long-acting beta2-agonist combination as a reliever, and as a reliever and a controller; and the escalation of controller medication for acute loss of asthma control as part of a self-management action plan. The expert panel followed an adaptation process to identify and appraise existing guidelines on the specified topics. In addition, literature searches were performed to identify relevant systematic reviews and randomized controlled trials. The panel formally assessed and graded the evidence, and made 34 recommendations. RESULTS: The updated guideline recommendations outline a role for inclusion of assessment of sputum eosinophils, in addition to standard measures of asthma control, to guide adjustment of controller therapy in adults with moderate to severe asthma. Appraisal of the evidence regarding which adjunct controller therapy to add to ICS and at what ICS dose to begin adjunct therapy in children and adults with poor asthma control supported the 2010 CTS Consensus Summary recommendations. New recommendations for the adjustment of controller medication within written action plans are provided. Finally, priority areas for future research were identified. CONCLUSIONS: The present clinical practice guideline is the first update of the CTS Asthma Guidelines following the Canadian Respiratory Guidelines Committee’s new guideline development process. Tools and strategies to support guideline implementation will be developed and the CTS will continue to regularly provide updates reflecting new evidence. PMID:22536582

Internal quality assurance in a clinical virology laboratory. II. Internal quality control.

PubMed Central

Gray, J J; Wreghitt, T G; McKee, T A; McIntyre, P; Roth, C E; Smith, D J; Sutehall, G; Higgins, G; Geraghty, R; Whetstone, R

1995-01-01

AIMS--In April 1991 additional quality control procedures were introduced into the virology section of the Clinical Microbiology and Public Health Laboratory, Cambridge. Internal quality control (IQC) samples were gradually included in the serological assays performed in the laboratory and supplemented kit controls and standard sera. METHODS--From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera. RESULTS--The IQC samples were evaluated according to the Westgard rules. Violations were recorded in 60 of 1808 (3.3%) controls and were highest in the IQC samples of complement fixation tests (25/312 (8%) of controls submitted for complement fixation tests). CONCLUSIONS--The inclusion of IQC samples in the serological assays performed in the laboratory has highlighted batch to batch variation in commercial assays. The setting of acceptable limits for the IQC samples has increased confidence in the validity of assay results. PMID:7730475

ESCMID guidelines for the management of the infection control measures to reduce transmission of multidrug-resistant Gram-negative bacteria in hospitalized patients.

PubMed

Tacconelli, E; Cataldo, M A; Dancer, S J; De Angelis, G; Falcone, M; Frank, U; Kahlmeter, G; Pan, A; Petrosillo, N; Rodríguez-Baño, J; Singh, N; Venditti, M; Yokoe, D S; Cookson, B

2014-01-01

Healthcare-associated infections due to multidrug-resistant Gram-negative bacteria (MDR-GNB) are a leading cause of morbidity and mortality worldwide. These evidence-based guidelines have been produced after a systematic review of published studies on infection prevention and control interventions aimed at reducing the transmission of MDR-GNB. The recommendations are stratified by type of infection prevention and control intervention and species of MDR-GNB and are presented in the form of 'basic' practices, recommended for all acute care facilities, and 'additional special approaches' to be considered when there is still clinical and/or epidemiological and/or molecular evidence of ongoing transmission, despite the application of the basic measures. The level of evidence for and strength of each recommendation, were defined according to the GRADE approach. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Lubiprostone: a new drug for the treatment of chronic idiopathic constipation.

PubMed

Baker, Danial E

2007-01-01

Lubiprostone offers an additional alternative for patients with chronic idiopathic constipation. Lubiprostone is more efficacious than placebo in the treatment of chronic idiopathic constipation. In placebo-controlled clinical trials, lubiprostone therapy was generally well tolerated and was not associated with severe adverse effects; however, the high incidence of nausea may be problematic for some patients. The nausea may be alleviated or minimized by administering the dose with food, and some patients may require a dosage reduction to 24 mug once daily. The key limitations of the placebo-controlled clinical trials include the absence of information regarding the duration of the constipation and previous types of therapies that had been used to treat the constipation and the absence of an active control group. Comparative studies with other therapies (eg, saline laxatives, polyethylene glycol) used for constipation are necessary to determine the clinical and economic value of this agent relative to other forms of therapy.

PATTERNS OF CLINICALLY SIGNIFICANT COGNITIVE IMPAIRMENT IN HOARDING DISORDER.

PubMed

Mackin, R Scott; Vigil, Ofilio; Insel, Philip; Kivowitz, Alana; Kupferman, Eve; Hough, Christina M; Fekri, Shiva; Crothers, Ross; Bickford, David; Delucchi, Kevin L; Mathews, Carol A

2016-03-01

The cognitive characteristics of individuals with hoarding disorder (HD) are not well understood. Existing studies are relatively few and somewhat inconsistent but suggest that individuals with HD may have specific dysfunction in the cognitive domains of categorization, speed of information processing, and decision making. However, there have been no studies evaluating the degree to which cognitive dysfunction in these domains reflects clinically significant cognitive impairment (CI). Participants included 78 individuals who met DSM-V criteria for HD and 70 age- and education-matched controls. Cognitive performance on measures of memory, attention, information processing speed, abstract reasoning, visuospatial processing, decision making, and categorization ability was evaluated for each participant. Rates of clinical impairment for each measure were compared, as were age- and education-corrected raw scores for each cognitive test. HD participants showed greater incidence of CI on measures of visual memory, visual detection, and visual categorization relative to controls. Raw-score comparisons between groups showed similar results with HD participants showing lower raw-score performance on each of these measures. In addition, in raw-score comparisons HD participants also demonstrated relative strengths compared to control participants on measures of verbal and visual abstract reasoning. These results suggest that HD is associated with a pattern of clinically significant CI in some visually mediated neurocognitive processes including visual memory, visual detection, and visual categorization. Additionally, these results suggest HD individuals may also exhibit relative strengths, perhaps compensatory, in abstract reasoning in both verbal and visual domains. © 2015 Wiley Periodicals, Inc.

Economic analysis of temperature-controlled laminar airflow (TLA) for the treatment of patients with severe persistent allergic asthma

PubMed Central

Brazier, Peter; Schauer, Uwe; Hamelmann, Eckard; Holmes, Steve; Pritchard, Clive; Warner, John O

2016-01-01

Introduction Chronic asthma is a significant burden for individual sufferers, adversely impacting their quality of working and social life, as well as being a major cost to the National Health Service (NHS). Temperature-controlled laminar airflow (TLA) therapy provides asthma patients at BTS/SIGN step 4/5 an add-on treatment option that is non-invasive and has been shown in clinical studies to improve quality of life for patients with poorly controlled allergic asthma. The objective of this study was to quantify the cost-effectiveness of TLA (Airsonett AB) technology as an add-on to standard asthma management drug therapy in the UK. Methods The main performance measure of interest is the incremental cost per quality-adjusted life year (QALY) for patients using TLA in addition to usual care versus usual care alone. The incremental cost of TLA use is based on an observational clinical study monitoring the incidence of exacerbations with treatment valued using NHS cost data. The clinical effectiveness, used to derive the incremental QALY data, is based on a randomised double-blind placebo-controlled clinical trial comprising participants with an equivalent asthma condition. Results For a clinical cohort of asthma patients as a whole, the incremental cost-effectiveness ratio (ICER) is £8998 per QALY gained, that is, within the £20 000/QALY cost-effectiveness benchmark used by the National Institute for Health and Care Excellence (NICE). Sensitivity analysis indicates that ICER values range from £18 883/QALY for the least severe patients through to TLA being dominant, that is, cost saving as well as improving quality of life, for individuals with the most severe and poorly controlled asthma. Conclusions Based on our results, Airsonett TLA is a cost-effective addition to treatment options for stage 4/5 patients. For high-risk individuals with more severe and less well controlled asthma, the use of TLA therapy to reduce incidence of hospitalisation would be a cost saving to the NHS. PMID:27026803

Comparative clinical evaluation of coronally advanced flap with or without platelet rich fibrin membrane in the treatment of isolated gingival recession

PubMed Central

Thamaraiselvan, Murugan; Elavarasu, Sugumari; Thangakumaran, Suthanthiran; Gadagi, Jayaprakash Sharanabasappa; Arthie, Thangavelu

2015-01-01

Aim: The aim of this study was to determine whether the addition of an autologous platelet rich fibrin (PRF) membrane to a coronally advanced flap (CAF) would improve the clinical outcome in terms of root coverage, in the treatment of isolated gingival recession. Materials and Methods: Systemically healthy 20 subjects each with single Miller's class I or II buccal recession defect were randomly assigned to control (CAF) or test (CAF + PRF) group. Clinical outcome was determined by measuring the following clinical parameters such as recession depth (RD), recession width (RW), probing depth (PD), clinical attachment level (CAL), width of keratinized tissue (WKT), gingival thickness (GTH), plaque index (PI), and gingival index (GI) at baseline, 3rd, and 6th month postsurgery. Results: The root coverage was 65.00 ± 44.47% in the control group and 74.16 ± 28.98% in the test group at 6th month, with no statistically significant difference between them. Similarly, CAL, PD, and WKT between the groups were not statistically significant. Conversely, there was statistically significant increase in GTH in the test group. Conclusion: CAF is a predictable treatment for isolated Miller's class I and II recession defects. The addition of PRF to CAF provided no added advantage in terms of root coverage except for an increase in GTH. PMID:25810596

Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

PubMed

Mello, Michelle M; Clarridge, Brian R; Studdert, David M

2005-01-01

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

Are elements of the chronic care model associated with cardiovascular risk factor control in type 2 diabetes?

PubMed

Parchman, Michael; Kaissi, Amer A

2009-03-01

Control of modifiable risk factors for cardiovascular (CV) disease, the most common cause of morbidity and mortality among people with Type 2 diabetes is dependent on both patient self-care behaviors and the characteristics of the clinic in which care is delivered. The relationship between control of CV risk factors, patient self-care behaviors, and the presence of CCM (Chronic Care Model) components across multiple primary care clinic settings was examined. Thirty consecutive patients presenting with Type 2 diabetes were enrolled from each of 20 primary care clinics from across South Texas. Patients were asked about their stage of change for four self-care behaviors: diet, exercise, glucose monitoring, and medication adherence. CV risk factors included the most recent values of glycosolated hemoglobin (A1C), blood pressure, and (low-density lipoprotein) cholesterol. Clinicians in each clinic completed the Assessment of Chronic Illness Care (ACIC) survey, a validated measure of the CCM components. Hierarchical logistic regression models were used. Only 25 (13%) of the 618 patients had good control of all three CV risk factors. Good control of these risk factors was positively associated with community linkages and delivery system design but was inversely associated with clinical information systems. Patients who were in the maintenance stage of change for all four self-care behaviors were more likely to have all three risk factors well controlled. Risk factors for CV disease among patients with diabetes are associated with the structure and design of the clinical microsystem where care is delivered. In addition to focusing on clinician knowledge, future interventions should address the clinical microsystem's structure and design to reduce the burden of CV disease among patients with Type 2 diabetes.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Children and young people with diabetes in Yorkshire: a population-based clinical audit of patient data 2005/2006.

PubMed

McKinney, P A; Feltbower, R G; Stephenson, C R; Reynolds, C

2008-11-01

To provide a population-based clinical audit of children and young people with diabetes, reporting outcomes, including glycaemic control, for named individual units. Clinical audit data on care processes and glycated haemoglobin (HbA(1c)) were collected for 1742 children and young people treated in 16 paediatric units in Yorkshire, from January 2005 to March 2006. The Yorkshire Register of Diabetes in Children and Young People provided information technology support and validation that enhanced data quality. Multi-level linear regression modelling investigated factors affecting glycaemic control. An HbA(1c) measure was recorded for 91.6% of patients. The National Institute for Clinical Excellence-recommended target level for HbA(1c) of < 7.5% was achieved for 14.7% of patients. HbA(1c) was positively associated with duration of diabetes and later age at diagnosis. Patients living in deprived areas had significantly poorer control compared with those from affluent areas. Significant between-unit variation in HbA(1c) was not reflected by any association with unit size. Our population-based clinical audit of children with diabetes is the product of an effective collaboration between those who deliver care and health services researchers. High levels of recording the key care process measuring diabetes control, compared with national figures, suggests collaboration has translated into improved services. The interesting association between poor diabetes control and higher deprivation is noteworthy and requires further investigation. Future audits require recording of clinical management and clinic structures, in addition to resources to record, assemble and analyse data.

The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries.

PubMed

Dalgard, Florence J; Gieler, Uwe; Tomas-Aragones, Lucia; Lien, Lars; Poot, Francoise; Jemec, Gregor B E; Misery, Laurent; Szabo, Csanad; Linder, Dennis; Sampogna, Francesca; Evers, Andrea W M; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Kupfer, Jörg

2015-04-01

The contribution of psychological disorders to the burden of skin disease has been poorly explored, and this is a large-scale study to ascertain the association between depression, anxiety, and suicidal ideation with various dermatological diagnoses. This international multicenter observational cross-sectional study was conducted in 13 European countries. In each dermatology clinic, 250 consecutive adult out-patients were recruited to complete a questionnaire, reporting socio-demographic information, negative life events, and suicidal ideation; depression and anxiety were assessed with the Hospital Anxiety and Depression Scale. A clinical examination was performed. A control group was recruited among hospital employees. There were 4,994 participants--3,635 patients and 1,359 controls. Clinical depression was present in 10.1% patients (controls 4.3%, odds ratio (OR) 2.40 (1.67-3.47)). Clinical anxiety was present in 17.2% (controls 11.1%, OR 2.18 (1.68-2.82)). Suicidal ideation was reported by 12.7% of all patients (controls 8.3%, OR 1.94 (1.33-2.82)). For individual diagnoses, only patients with psoriasis had significant association with suicidal ideation. The association with depression and anxiety was highest for patients with psoriasis, atopic dermatitis, hand eczema, and leg ulcers. These results identify a major additional burden of skin disease and have important clinical implications.

The Psychological Burden of Skin Diseases: A Cross-Sectional Multicenter Study among Dermatological Out-Patients in 13 European Countries

PubMed Central

Dalgard, Florence J; Gieler, Uwe; Tomas-Aragones, Lucia; Lien, Lars; Poot, Francoise; Jemec, Gregor B E; Misery, Laurent; Szabo, Csanad; Linder, Dennis; Sampogna, Francesca; Evers, Andrea W M; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Kupfer, Jörg

2015-01-01

The contribution of psychological disorders to the burden of skin disease has been poorly explored, and this is a large-scale study to ascertain the association between depression, anxiety, and suicidal ideation with various dermatological diagnoses. This international multicenter observational cross-sectional study was conducted in 13 European countries. In each dermatology clinic, 250 consecutive adult out-patients were recruited to complete a questionnaire, reporting socio-demographic information, negative life events, and suicidal ideation; depression and anxiety were assessed with the Hospital Anxiety and Depression Scale. A clinical examination was performed. A control group was recruited among hospital employees. There were 4,994 participants––3,635 patients and 1,359 controls. Clinical depression was present in 10.1% patients (controls 4.3%, odds ratio (OR) 2.40 (1.67–3.47)). Clinical anxiety was present in 17.2% (controls 11.1%, OR 2.18 (1.68–2.82)). Suicidal ideation was reported by 12.7% of all patients (controls 8.3%, OR 1.94 (1.33–2.82)). For individual diagnoses, only patients with psoriasis had significant association with suicidal ideation. The association with depression and anxiety was highest for patients with psoriasis, atopic dermatitis, hand eczema, and leg ulcers. These results identify a major additional burden of skin disease and have important clinical implications. PMID:25521458

Additive Effect of Plasma Rich in Growth Factors With Guided Tissue Regeneration in Treatment of Intrabony Defects in Patients With Chronic Periodontitis: A Split-Mouth Randomized Controlled Clinical Trial.

PubMed

Ravi, Sheethalan; Malaiappan, Sankari; Varghese, Sheeja; Jayakumar, Nadathur D; Prakasam, Gopinath

2017-09-01

Periodontal regeneration can be defined as complete restoration of lost periodontal tissues to their original architecture and function. A variety of treatment modalities have been proposed to achieve it. Plasma rich in growth factors (PRGF) is a concentrated suspension of growth factors that promotes restoration of lost periodontal tissues. The objective of the present study is to assess the effect of PRGF associated with guided tissue regeneration (GTR) versus GTR only in the treatment of intrabony defects (IBDs) in patients with chronic periodontitis (CP). Patients with CP (n = 14) with 42 contralateral 2- and 3-walled defects were randomly assigned to test (PRGF+GTR) and control (GTR alone) treatment groups. Clinical and radiographic assessments performed at baseline and after 6 months were: 1) gingival index (GI), 2) probing depth (PD), 3) clinical attachment level (CAL), 4) radiologic defect depth, and 5) bone fill. Comparison of parameters measured at baseline and after 6 months showed mean PD reduction of 3.37 ± 1.62 mm in the control group (P <0.001) and 4.13 ± 1.59 mm in the test group (P <0.001). There was a significant difference in mean change in CAL (P <0.001) in the control group (5.42 ± 1.99) and the test group (5.99 ± 1.77). Mean change in GI was 1.89 ± 0.32 and 1.68 ± 0.58 in the control group and test group, respectively, and the difference was statistically significant (P <0.001). When compared between groups, clinical parameters did not show any statistically significant variations. Mean radiographic bone fill was 1.06 ± 0.81 and 1.0 ± 0.97 in the control group and test group, respectively. However, the difference was not statistically significant. PRGF with GTR, as well as GTR alone, was effective in improving clinical and radiographic parameters of patients with CP at the 6-month follow-up. There was no additive effect of PRGF when used along with GTR in the treatment of IBDs in patients with CP in terms of both clinical and radiologic outcomes.

[Application of SAS macro to evaluated multiplicative and additive interaction in logistic and Cox regression in clinical practices].

PubMed

Nie, Z Q; Ou, Y Q; Zhuang, J; Qu, Y J; Mai, J Z; Chen, J M; Liu, X Q

2016-05-01

Conditional logistic regression analysis and unconditional logistic regression analysis are commonly used in case control study, but Cox proportional hazard model is often used in survival data analysis. Most literature only refer to main effect model, however, generalized linear model differs from general linear model, and the interaction was composed of multiplicative interaction and additive interaction. The former is only statistical significant, but the latter has biological significance. In this paper, macros was written by using SAS 9.4 and the contrast ratio, attributable proportion due to interaction and synergy index were calculated while calculating the items of logistic and Cox regression interactions, and the confidence intervals of Wald, delta and profile likelihood were used to evaluate additive interaction for the reference in big data analysis in clinical epidemiology and in analysis of genetic multiplicative and additive interactions.

Exploring Organizational Barriers to Strengthening Clinical Supervision of Psychiatric Nursing Staff: A Longitudinal Controlled Intervention Study.

PubMed

Gonge, Henrik; Buus, Niels

2016-05-01

This article reports findings from a longitudinal controlled intervention study of 115 psychiatric nursing staff. The twofold objective of the study was: (a) To test whether the intervention could increase clinical supervision participation and effectiveness of existing supervision practices, and (b) To explore organizational constraints to implementation of these strengthened practices. Questionnaire responses and registration of participation in clinical supervision were registered prior and subsequent to the intervention consisting of an action learning oriented reflection on staff's existing clinical supervision practices. Major organizational changes in the intervention group during the study period obstructed the implementation of strengthened clinical supervision practices, but offered an opportunity for studying the influences of organizational constraints. The main findings were that a) diminishing experience of social support from colleagues was associated with reduced participation in clinical supervision, while b) additional quantitative demands were associated with staff reporting difficulties finding time for supervision. This probably explained a negative development in the experienced effectiveness of supervision. It is concluded that organizational support is an imperative for implementation of clinical supervision.

Simulation techniques in hyperthermia treatment planning

PubMed Central

Paulides, MM; Stauffer, PR; Neufeld, E; Maccarini, P; Kyriakou, A; Canters, RAM; Diederich, C; Bakker, JF; Van Rhoon, GC

2013-01-01

Clinical trials have shown that hyperthermia (HT), i.e. an increase of tissue temperature to 39-44°C, significantly enhance radiotherapy and chemotherapy effectiveness (1). Driven by the developments in computational techniques and computing power, personalized hyperthermia treatment planning (HTP) has matured and has become a powerful tool for optimizing treatment quality. Electromagnetic, ultrasound, and thermal simulations using realistic clinical setups are now being performed to achieve patient-specific treatment optimization. In addition, extensive studies aimed to properly implement novel HT tools and techniques, and to assess the quality of HT, are becoming more common. In this paper, we review the simulation tools and techniques developed for clinical hyperthermia, and evaluate their current status on the path from “model” to “clinic”. In addition, we illustrate the major techniques employed for validation and optimization. HTP has become an essential tool for improvement, control, and assessment of HT treatment quality. As such, it plays a pivotal role in the quest to establish HT as an efficacious addition to multi-modality treatment of cancer. PMID:23672453

Green tea (Camellia sinensis) for patients with knee osteoarthritis: A randomized open-label active-controlled clinical trial.

PubMed

Hashempur, Mohammad Hashem; Sadrneshin, Sara; Mosavat, Seyed Hamdollah; Ashraf, Alireza

2018-02-01

Green tea is known as a dietary supplement and a novel functional food worldwide. Since there are increasing preclinical evidence about efficacy of green tea for treating osteoarthritis, this study has aimed at assessing its efficacy and safety for patients with knee osteoarthritis. This is a randomized open-label active-controlled clinical trial. As many as fifty adults with osteoarthritis of knee were randomly allocated to receive the green tea extract (in dosage form of tablet) plus diclofenac tablet as "intervention group"; or: diclofenac tablet alone as "control group" for a period of four weeks. Patients were assessed at the beginning of intervention, and then 4 weeks later, in terms of pain score via visual analogue scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire's total score in addition to its 3 sub-scores. Furthermore, they were asked about any adverse effects during intervention period. Mean differences of VAS pain, total WOMAC, and WOMAC physical function scores in green tea group showed a significant reduction, compared with the control group (P = 0.038, P = 0.006, and P = 0.004, respectively). However, No significant differences between the two groups were observed, regarding mean differences of WOMAC pain and stiffness scores of the enrolled patients (P = 0.163, and P = 0.150, respectively). Additionally, only 1 patient reported gastric upset [in control group]. It seems that green tea extract might well be considered as an adjunctive treatment both for control of pain and for the betterment of knee joint physical function in adults with osteoarthritis. However, further studies of longer duration and larger sample size are needed. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Selective classification for improved robustness of myoelectric control under nonideal conditions.

PubMed

Scheme, Erik J; Englehart, Kevin B; Hudgins, Bernard S

2011-06-01

Recent literature in pattern recognition-based myoelectric control has highlighted a disparity between classification accuracy and the usability of upper limb prostheses. This paper suggests that the conventionally defined classification accuracy may be idealistic and may not reflect true clinical performance. Herein, a novel myoelectric control system based on a selective multiclass one-versus-one classification scheme, capable of rejecting unknown data patterns, is introduced. This scheme is shown to outperform nine other popular classifiers when compared using conventional classification accuracy as well as a form of leave-one-out analysis that may be more representative of real prosthetic use. Additionally, the classification scheme allows for real-time, independent adjustment of individual class-pair boundaries making it flexible and intuitive for clinical use.

A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

PubMed

Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

2007-09-01

Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

Highly Sensitive Assay for Detection of Enterovirus in Clinical Specimens by Reverse Transcription-PCR with an Armored RNA Internal Control

PubMed Central

Beld, Marcel; Minnaar, René; Weel, Jan; Sol, Cees; Damen, Marjolein; van der Avoort, Harry; Wertheim-van Dillen, Pauline; Breda, Alex van; Boom, René

2004-01-01

The objective of the present study was the development of a diagnostic reverse transcription (RT)-PCR for the specific detection of enterovirus (EV) RNA in clinical specimens controlled by an internal control (IC) RNA. The IC RNA contains the same primer binding sites as EV RNA but has a different probe region. The IC RNA was packaged into an MS2 phage core particle (armored) and was added to the clinical sample to allow monitoring of both extraction efficiency and RT-PCR efficiency. Serial dilutions of the IC RNA were made, and the detection limit of the RT-PCR was tested in a background of EV RNA-negative cerebrospinal fluid. The sensitivity and specificity of the RT-PCR assay were tested by using all 64 known EV serotypes, several non-EV serotypes, and two Quality Control for Molecular Diagnostics (QCMD) Program EV proficiency panels from 2001 and 2002. In total, 322 clinical specimens were tested by RT-PCR, and to establish the clinical utility of the RT-PCR, a comparison of the results of viral culture and RT-PCR was done with 87 clinical specimens. The lower limit of sensitivity was reached at about 150 copies of IC RNA/ml. All 64 EV serotypes were positive, while all non-EV serotypes were negative. All culture-positive samples of the 2001 QCMD proficiency panel (according to the 50% tissue culture infective doses per milliliter) were positive by RT-PCR. Invalid results, i.e., negativity for both EV RNA and IC RNA, due to inhibition of RT-PCR were observed for 33.3% of the members of the 2002 QCMD proficiency panel and 3.1% of the clinical specimens. Inhibition of RT-PCR could be relieved by the addition of 400 ng of bovine α-casein per μl to both the RT reaction mixture and the PCR mixture. With this optimized protocol, the results for all samples of the 2002 QCMD proficiency panel and all clinical specimens except one fecal sample (0.3%) were valid. Evaluation of the clinical samples demonstrated that EV infection could be detected in 12 of 87 samples (13.8%) by RT-PCR, while viral culture was negative. Our data show that the RT-PCR with armored IC RNA offers a very reliable and rapid diagnostic tool for the detection of EV in clinical specimens and that the addition of bovine α-casein relieved inhibition of the RT-PCR for 99.7% of clinical specimens. PMID:15243060

Clinical and socioeconomic determinants of congenital syphilis in Posadas, Argentina.

PubMed

Parker, Lucy Anne; Deschutter, Enrique Jorge; Bornay-Llinares, Fernando Jorge; Hernandez-Aguado, Ildefonso; Silva, Gustavo; Piragine, Rosa Del Carmen; Lumbreras, Blanca

2012-04-01

To explore clinical and socioeconomic factors related to congenital syphilis in Posadas, Argentina. Data were collected from 102 mothers who had given birth to an infant with congenital syphilis at Dr. Ramón Madariaga Central Hospital (2005-2007) and 306 control mothers. Clinical and demographic information were collected from clinical records, and socioeconomic details were obtained by interview. Multivariable logistic regression was used to explore the relationships between congenital syphilis and clinical and socioeconomic factors. Receiving the recommended number of prenatal health checks had a clear protective effect on congenital syphilis in the univariate analysis (odds ratio (OR) 0.52, 95% confidence interval (CI) 0.31-0.86), as did being in a stable relationship (OR 0.23, 95% CI 0.14-0.38). Furthermore, women with secondary education or above were over four-times less likely to have a child with congenital syphilis compared to women who had not completed primary school education, even after controlling for the number of prenatal health checks and other factors (adjusted OR 0.24, 95% CI 0.08-0.72). In addition, women with previous stillborn births were over three-times more likely to have a baby with congenital syphilis after controlling for education and prenatal care (adjusted OR 3.37, 95% CI 1.24-9.16). There is a clear opportunity for reducing the burden of congenital syphilis by promoting syphilis screening and treatment in women with previous stillborn births. In addition, the potential impact of more general policies addressing social determinants of health, such as those improving education, must not be overlooked. Copyright © 2012 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Photodynamic therapy as an adjunct to non-surgical periodontal treatment: a randomized, controlled clinical trial.

PubMed

Christodoulides, Nicos; Nikolidakis, Dimitris; Chondros, Panagiotis; Becker, Jürgen; Schwarz, Frank; Rössler, Ralf; Sculean, Anton

2008-09-01

Recent preclinical and clinical data have suggested a potential benefit of photodynamic therapy (PDT) in the treatment of periodontitis. However, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis. The aim of this study was to evaluate the clinical and microbiologic effects of the adjunctive use of PDT to non-surgical periodontal treatment. Twenty-four subjects with chronic periodontitis were randomly treated with scaling and root planing followed by a single episode of PDT (test) or scaling and root planing alone (control). Full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), gingival recession, and clinical attachment level (CAL) were measured at baseline and 3 and 6 months after therapy. Primary outcome variables were changes in PD and CAL. Microbiologic evaluation of Aggregatibacter actinomycetemcomitans (previously Actinobacillus actinomycetemcomitans), Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia (previously T. forsythensis), Treponema denticola, Parvimonas micra (previously Peptostreptococcus micros or Micromonas micros), Fusobacterium nucleatum, Campylobacter rectus, Eubacterium nodatum, Eikenella corrodens, and Capnocytophaga spp. was performed at baseline and 3 and 6 months following therapy by using a commercially available polymerase chain reaction test. At 3 and 6 months after treatment, there were no statistically significant differences between the groups with regard to CAL, PD, FMPS, or microbiologic changes. At 3 and 6 months, a statistically significantly greater improvement in FMBS was found in the test group. The additional application of a single episode of PDT to scaling and root planing failed to result in an additional improvement in terms of PD reduction and CAL gain, but it resulted in a significantly higher reduction in bleeding scores compared to scaling and root planing alone.

Ectoparasite Burden, Clinical Disease, and Immune Responses throughout Fur Mite (Myocoptes musculinus) Infestation in C57BL/6 and Rag1–/– Mice

PubMed Central

Moats, Cassandra R; Baxter, Victoria K; Pate, Nathan M; Watson, Julie

2016-01-01

Immunocompetent weanling mice infested with Myocoptes musculinus harbor high mite loads, yet burdens decrease with age. The development of immunity to the parasite may explain this observation. In this study, we followed M. musculinus burdens in Rag1−/− mice and immunocompetent C57BL/6 controls from 4 to 36 wk of age and compared the clinical signs and body weights of noninfested and infested mice of both strains over time. In addition, histopathology of skin lesions and expression of cytokines and transcription factors associated with Th1- and Th2-type immune responses were assessed. Myocoptes burdens decreased and remained low in B6 mice over time, whereas Rag1−/− mice showed an initial decrease in burdens after 4 wk of age followed by an increase from 24 to 36 wk. In addition, Rag1−/− mice had higher burdens than B6 mice over time. Both strains of infested mice exhibited clinical signs of fur mite infestation—including alopecia, poor weight gain, mite-associated debris, and pruritus—and clinical signs positively correlated with the severity of the Myocoptes burden. Histopathology of skin from both strains of infested mice showed decreased lesion severity with age, likely a result of declining mite populations. Finally, compared with noninfested controls, infested B6 mice had increased expression of markers associated with the Th2-type immune response, which increased in magnitude with increasing age and duration of infestation. These results suggest that development of adaptive immunity plays a role in control of fur mite populations and that heavier infestations may result in more severe clinical signs and skin lesions. PMID:27298244

An Automated Treatment Plan Quality Control Tool for Intensity-Modulated Radiation Therapy Using a Voxel-Weighting Factor-Based Re-Optimization Algorithm.

PubMed

Song, Ting; Li, Nan; Zarepisheh, Masoud; Li, Yongbao; Gautier, Quentin; Zhou, Linghong; Mell, Loren; Jiang, Steve; Cerviño, Laura

2016-01-01

Intensity-modulated radiation therapy (IMRT) currently plays an important role in radiotherapy, but its treatment plan quality can vary significantly among institutions and planners. Treatment plan quality control (QC) is a necessary component for individual clinics to ensure that patients receive treatments with high therapeutic gain ratios. The voxel-weighting factor-based plan re-optimization mechanism has been proved able to explore a larger Pareto surface (solution domain) and therefore increase the possibility of finding an optimal treatment plan. In this study, we incorporated additional modules into an in-house developed voxel weighting factor-based re-optimization algorithm, which was enhanced as a highly automated and accurate IMRT plan QC tool (TPS-QC tool). After importing an under-assessment plan, the TPS-QC tool was able to generate a QC report within 2 minutes. This QC report contains the plan quality determination as well as information supporting the determination. Finally, the IMRT plan quality can be controlled by approving quality-passed plans and replacing quality-failed plans using the TPS-QC tool. The feasibility and accuracy of the proposed TPS-QC tool were evaluated using 25 clinically approved cervical cancer patient IMRT plans and 5 manually created poor-quality IMRT plans. The results showed high consistency between the QC report quality determinations and the actual plan quality. In the 25 clinically approved cases that the TPS-QC tool identified as passed, a greater difference could be observed for dosimetric endpoints for organs at risk (OAR) than for planning target volume (PTV), implying that better dose sparing could be achieved in OAR than in PTV. In addition, the dose-volume histogram (DVH) curves of the TPS-QC tool re-optimized plans satisfied the dosimetric criteria more frequently than did the under-assessment plans. In addition, the criteria for unsatisfied dosimetric endpoints in the 5 poor-quality plans could typically be satisfied when the TPS-QC tool generated re-optimized plans without sacrificing other dosimetric endpoints. In addition to its feasibility and accuracy, the proposed TPS-QC tool is also user-friendly and easy to operate, both of which are necessary characteristics for clinical use.

Male-only clinics: a success story in Colombia.

PubMed

Goldman, R

1987-04-01

2 male-only reproductive health clinics in Colombia are refuting the stereotype that Latin American men reject vasectomy as a threat to their machismo image and consider birth control to be a woman's responsibility. Over 1000 vasectomies were performed in the 2 clinics in Bogota and Medellin in 1986. The clinics are operated by PROFAMILIA and supported by the Association for Voluntary Surgical Contraception. Information about these male-only clinics is dispersed through radio announcements, magazine advertisements, and newspaper articles. The cost of services at these clinics is 50% less than services provided at other family facilities. These clinics demonstrate that Colombian men are willing to share family planning responsibilities if services are offered in a manner respectful of their needs. 3 additional male-only clinics are scheduled to open in Colombia in 1987.

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

PubMed Central

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

2013-01-01

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

Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

PubMed

Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

2017-09-01

To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

EFFECT OF A DENTIFRICE CONTAINING ALOE VERA ON PLAQUE AND GINGIVITIS CONTROL. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

PubMed Central

de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

2008-01-01

The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) – dentifrice containing Aloe vera - or the control group (n=15) – fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice. PMID:19089263

Effect of a dentifrice containing Aloe vera on plaque and gingivitis control. A double-blind clinical study in humans.

PubMed

de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

2008-01-01

The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) - dentifrice containing Aloe vera - or the control group (n=15) - fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice.

Treatment of Focal Articular Cartilage Defects in the Knee

PubMed Central

Magnussen, Robert A.; Dunn, Warren R.; Carey, James L.

2008-01-01

We asked whether autologous chondrocyte implantation or osteochondral autograft transfer yields better clinical outcomes compared with one another or with traditional abrasive techniques for treatment of isolated articular cartilage defects and whether lesion size influences this clinical outcome. We performed a literature search and identified five randomized, controlled trials and one prospective comparative trial evaluating these treatment techniques in 421 patients. The operative procedures included autologous chondrocyte implantation, osteochondral autograft transfer, matrix-induced autologous chondrocyte implantation, and microfracture. Minimum followup was 1 year (mean, 1.7 years; range, 1–3 years). All studies documented greater than 95% followup for clinical outcome measures. No technique consistently had superior results compared with the others. Outcomes for microfracture tended to be worse in larger lesions. All studies reported improvement in clinical outcome measures in all treatment groups when compared with preoperative assessment; however, no control (nonoperative) groups were used in any of the studies. A large prospective trial investigating these techniques with the addition of a control group would be the best way to definitively address the clinical questions. Level of Evidence: Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18196358

A controlled study of agoraphobia and the independent effect of virtual reality exposure therapy.

PubMed

Malbos, Eric; Rapee, Ronald M; Kavakli, Manolya

2013-02-01

Past controlled clinical trials centred on virtual reality exposure therapy (VRET) for agoraphobia mostly used multicomponent therapy with success. However, the present paper aimed to evaluate the independent effect of VRET for agoraphobia. A controlled study involving 18 agoraphobic participants assigned to two groups: VRET only and VRET with cognitive therapy. Nine specific virtual environments were developed using an affordable game level editor. Questionnaires, behavioural tests and physiological measures indicated a positive effect of VRET. Correlations supported the predictive value of presence towards treatment outcome. The addition of cognitive therapy did not provide significant additional benefit. Overall, the isolated effects of VRET did not seem to be significantly less than the effects of VRET combined with cognitive therapy. Future research should explore the use of other components in addition to cognitive therapy and VRET for agoraphobia as well as its possible use in patients' homes.

Bridging the gap between the neurocognitive lab and the addiction clinic.

PubMed

Franken, Ingmar H A; van de Wetering, Ben J M

2015-05-01

In the past decennium there has been an enormous increase in new insights in cognitive mechanisms of addiction and their neural substrates. These candidate neurocognitive mechanisms, particularly those associated with "drive" and "control" aspects of addiction, are clearly involved in substance use problems but do not yet provide a full explanation. The neurocognitive mechanisms addressed in the present perspective are attentional bias, reward processing (both drive aspects) and error-processing and cognitive control (both control aspects). The time has come to transfer these recent insights more consistently to clinical practice by studying their relevance for diagnosis and treatment in patient samples. The present perspective echoes the development of recent initiatives such as the RDoC system to integrate developments in neuroscience into clinical practice. The aim of this article is to open new vistas for addiction diagnosis and treatment and to discuss why and how these neurocognitive aspects of addictive behavior can be used in clinical practice. In addition, present problematic issues and a future research agenda are provided. Copyright © 2014 Elsevier Ltd. All rights reserved.

Verbal Memory Impairment in Polydrug Ecstasy Users: A Clinical Perspective.

PubMed

Kuypers, Kim P C; Theunissen, Eef L; van Wel, Janelle H P; de Sousa Fernandes Perna, Elizabeth B; Linssen, Anke; Sambeth, Anke; Schultz, Benjamin G; Ramaekers, Johannes G

2016-01-01

Ecstasy use has been associated with short-term and long-term memory deficits on a standard Word Learning Task (WLT). The clinical relevance of this has been debated and is currently unknown. The present study aimed at evaluating the clinical relevance of verbal memory impairment in Ecstasy users. To that end, clinical memory impairment was defined as decrement in memory performance that exceeded the cut-off value of 1.5 times the standard deviation of the average score in the healthy control sample. The primary question was whether being an Ecstasy user (E-user) was predictive of having clinically deficient memory performance compared to a healthy control group. WLT data were pooled from four experimental MDMA studies that compared memory performance during placebo and MDMA intoxication. Control data were taken from healthy volunteers with no drug use history who completed the WLT as part of a placebo-controlled clinical trial. This resulted in a sample size of 65 E-users and 65 age- and gender-matched healthy drug-naïve controls. All participants were recruited by similar means and were tested at the same testing facilities using identical standard operating procedures. Data were analyzed using linear mixed-effects models, Bayes factor, and logistic regressions. Findings were that verbal memory performance of placebo-treated E-users did not differ from that of controls, and there was substantial evidence in favor of the null hypothesis. History of use was not predictive of memory impairment. During MDMA intoxication of E-users, verbal memory was impaired. The combination of the acute and long-term findings demonstrates that, while clinically relevant memory impairment is present during intoxication, it is absent during abstinence. This suggests that use of Ecstasy/MDMA does not lead to clinically deficient memory performance in the long term. Additionally, it has to be investigated whether the current findings apply to more complex cognitive measures in diverse 'user categories' using a combination of genetics, imaging techniques and neuropsychological assessments.

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

PubMed

Chen, Qi-Fen; Zhang, Yi-Wei

2018-02-01

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

Upper gastrointestinal bleeding caused by severe esophagitis: a unique clinical syndrome.

PubMed

Guntipalli, Prathima; Chason, Rebecca; Elliott, Alan; Rockey, Don C

2014-12-01

We have recognized a unique clinical syndrome in patients with upper gastrointestinal bleeding who are found to have severe esophagitis. We aimed to more clearly describe the clinical entity of upper gastrointestinal bleeding in patients with severe esophagitis. We conducted a retrospective matched case-control study designed to investigate clinical features in patients with carefully defined upper gastrointestinal bleeding and severe esophagitis. Patient data were captured prospectively via a Gastrointestinal Bleeding Healthcare Registry, which collects data on all patients admitted with gastrointestinal bleeding. Patients with endoscopically documented esophagitis (cases) were matched with randomly selected controls that had upper gastrointestinal bleeding caused by other lesions. Epidemiologic features in patients with esophagitis were similar to those with other causes of upper gastrointestinal bleeding. However, hematemesis was more common in patients with esophagitis 86% (102/119) than in controls 55% (196/357) (p < 0.0001), while melena was less common in patients with esophagitis 38% (45/119) than in controls 68% (244/357) (p < 0.0001). Additionally, the more severe the esophagitis, the more frequent was melena. Patients with esophagitis had less abnormal vital signs, lesser decreases in hematocrit, and lesser increases in BUN. Both pre- and postRockall scores were lower in patients with esophagitis compared with controls (p = 0.01, and p < 0.0001, respectively). Length of hospital stay (p = 0.002), rebleeding rate at 42 days (p = 0.0007), and mortality were less in patients with esophagitis than controls. Finally, analysis of patients with esophagitis and cirrhosis suggested that this group of patients had more severe bleeding than those without cirrhosis. We have described a unique clinical syndrome in patients with upper gastrointestinal bleeding who have erosive esophagitis. This syndrome is manifest by typical clinical features and is associated with favorable outcomes.

Home blood pressure monitoring and self-titration of antihypertensive medications: Proposed patient selection criteria.

PubMed

Hill, James R

2016-05-01

Recent studies have demonstrated that home blood pressure monitoring (HBPM), coupled with self-titration of medications is a viable intervention to control hypertension. There are currently no established criteria to evaluate patients for inclusion in such a program. The purpose of this discussion is to propose criteria for determining if a patient is appropriate to participate in a program of HBPM and self-titration. Inclusion criteria for two self-titration trials were examined, and additional factors in clinical practice were identified and discussed. Additional selection criteria were proposed to support the decision to enroll a patient in an antihypertensive self-titration program. Inclusion criteria from self-titration trials provide a reasonable starting point for choosing appropriate patients in clinical practice, but additional research is necessary. Adaptation of these criteria and consideration of the identified factors can be used to develop decision support instruments. Such instruments should be evaluated for effectiveness and reliability prior to use in clinical practice. HBPM combined with self-titration is an effective patient-centered approach for hypertension management. Decision support instruments to determine appropriate patients are necessary for safe and effective use in clinical practice. ©2015 American Association of Nurse Practitioners.

Infarction of Uterine Fibroids After Embolization: Relationship Between Postprocedural Enhanced MRI Findings and Long-Term Clinical Outcomes

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

Katsumori, Tetsuya, E-mail: katsumo@eurus.dti.ne.jp; Kasahara, Toshiyuki; Kin, Yoko

2008-01-15

Purpose. To retrospectively evaluate the relationship between the degree of infarction of uterine fibroids on enhanced MRI after embolization and long-term clinical outcomes. Methods. During 92 months, 290 consecutive patients with symptomatic uterine fibroids were treated with embolization; 221 who underwent enhanced MRI before embolization and 1 week after embolization were included in this study. The infarction rates of all fibroid tissue were assessed using enhanced MRI after embolization. Patients were divided into three groups according to the infarction rates: group A (100% infarction, n 142), group B (90-99% infarction, n = 74), group C (<90% infarction, n = 5).more » The cumulative rates of clinical outcomes were compared among groups using the Kaplan-Meier limited method. Results. Group A had a significantly higher rate of symptom control than groups B and C. The cumulative rates of symptom control at 5 years were 93%, 71%, and 60% in groups A, B, and C, respectively. Group A had a significantly lower rate of gynecologic intervention after embolization than groups B and C. The cumulative rates of additional gynecologic intervention at 5 years were 3%, 15%, and 20% in groups A, B, and C, respectively. Conclusions. The degree of infarction of uterine fibroids after embolization on enhanced MRI was related to long-term clinical outcomes. Complete infarction of all fibroid tissue can induce a higher rate of symptom control, with a lower rate of additional gynecologic intervention in the long term compared with incomplete infarction of fibroid tissue.« less

Impact of autologous blood injections in treatment of mid-portion Achilles tendinopathy: double blind randomised controlled trial.

PubMed

Bell, Kevin J; Fulcher, Mark L; Rowlands, David S; Kerse, Ngaire

2013-04-18

To assess the effectiveness of two peritendinous autologous blood injections in addition to a standardised eccentric calf strengthening programme in improving pain and function in patients with mid-portion Achilles tendinopathy. Single centre, participant and single assessor blinded, parallel group, randomised, controlled trial. Single sports medicine clinic in New Zealand. 53 adults (mean age 49, 53% men) with symptoms of unilateral mid-portion Achilles tendinopathy for at least three months. Participants were excluded if they had a history of previous Achilles tendon rupture or surgery or had undergone previous adjuvant treatments such as injectable therapies, glyceryl trinitrate patches, or extracorporeal shockwave therapy. All participants underwent two unguided peritendinous injections one month apart with a standardised protocol. The treatment group had 3 mL of their own whole blood injected while the control group had no substance injected (needling only). Participants in both groups carried out a standardised and monitored 12 week eccentric calf training programme. Follow-up was at one, two, three and six months. The primary outcome measure was the change in symptoms and function from baseline to six months with the Victorian Institute of Sport Assessment-Achilles (VISA-A) score. Secondary outcomes were the participant's perceived rehabilitation and their ability to return to sport. 26 participants were randomly assigned to the treatment group and 27 to the control group. In total, 50 (94%) completed the six month study, with 25 in each group. Clear and clinically worthwhile improvements in the VISA-A score were evident at six months in both the treatment (change in score 18.7, 95% confidence interval 12.3 to 25.1) and control (19.9, 13.6 to 26.2) groups. The overall effect of treatment was not significant (P=0.689) and the 95% confidence intervals at all points precluded clinically meaningful benefit or harm. There was no significant difference between groups in secondary outcomes or in the levels of compliance with the eccentric calf strengthening programme. No adverse events were reported. The administration of two unguided peritendinous autologous blood injections one month apart, in addition to a standardised eccentric training programme, provides no additional benefit in the treatment of mid-portion Achilles tendinopathy. Australian New Zealand Clinical Trials Registry ACTRN12610000824066, WHO U1111-1117-2641.

Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program.

PubMed

Blumenfeld, Andrew; Silberstein, Stephen D; Dodick, David W; Aurora, Sheena K; Turkel, Catherine C; Binder, William J

2010-10-01

Chronic migraine (CM) is a prevalent and disabling neurological disorder. Few prophylactic treatments for CM have been investigated. OnabotulinumtoxinA, which inhibits the release of nociceptive mediators, such as glutamate, substance P, and calcitonin gene-related peptide, has been evaluated in randomized, placebo-controlled studies for the preventive treatment of a variety of headache disorders, including CM. These studies have yielded insight into appropriate patient selection, injection sites, dosages, and technique. Initial approaches used a set of fixed sites for the pericranial injections. However, the treatment approach evolved to include other sites that corresponded to the location of pain and tenderness in the individual patient in addition to the fixed sites. The Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) injection paradigm uses both fixed and follow-the-pain sites, with additional specific follow-the-pain sites considered depending on individual symptoms. The PREEMPT paradigm for injecting onabotulinumtoxinA has been shown to be safe, well-tolerated, and effective in well-designed, controlled clinical trials and is the evidence-based approach recommended to optimize clinical outcomes for patients with CM. © 2010 American Headache Society.

Polyphenol-based nutraceuticals for the prevention and treatment of cardiovascular disease: Review of human evidence.

PubMed

Tomé-Carneiro, Joao; Visioli, Francesco

2016-10-15

In addition to prescription drugs, nutraceuticals/functional foods/medical foods are being increasingly added as adjunct treatment of cardiovascular disease (CVD), even though most of them have been exclusively studied in vitro. We review the available evidence (focusing on when the amount of polyphenols' intake was measured) coming from randomized controlled trials (RCTs) of (poly)phenol-based supplements. We conclude that (poly)phenol-based nutraceuticals and functional foods might be indeed used as adjunct therapy of CVD, but additional long-term RCTs with adequate numerosity and with clinically relevant end points are needed to provide unequivocal evidence of their clinical usefulness. Copyright © 2015. Published by Elsevier GmbH.

Adjunctive clinical effect of a water-cooled Nd:YAG laser in a periodontal maintenance care programme: a randomized controlled trial.

PubMed

Slot, Dagmar E; Timmerman, Mark F; Versteeg, Paula A; van der Velden, Ubele; van der Weijden, Fridus A

2012-12-01

Various laser systems are currently available for intra-oral use. Neodymium:Yttrium-Aluminium Garnet lasers(Nd:YAG) have been approved by the US Food and Drug Administration for soft tissue treatment in the oral cavity. The aim of this study was to test whether the use of a water-cooled Nd:YAG laser during a maintenance care programme as an adjunct to supragingival and subgingival debridement (scaling and root planing, SRP) with hand and ultrasonic instruments results in clinical improvement compared with SRP alone. This study was an examiner-blind, randomized and controlled clinical trial using a split-mouth design. Thirty subjects were selected, originally diagnosed with moderate to severe generalized periodontitis, following a periodontal maintenance care programme (PMC). Immediately after SRP in two randomly assigned contra-lateral quadrants, all pockets ≥5 mm were additionally treated with a Nd:YAG laser (1064 nm, 4W, 250-μsec pulse). Clinical assessments [probing pocket depth PPD, bleeding on pocket probing (BOPP)] were performed pre-treatment and at 6 months. Based on these assessments, the periodontal inflamed surface area (PISA) was calculated. At 6 months, the clinical parameters had significantly improved for both regimens. No statistically significant differences between treatment modalities were observed for PPD and BOPP scores at any time. PISA scores supported these findings. In residual pockets ≥5 mm, treated in a PMC, the adjunctive use of an Nd:YAG laser does not provide a clinically significant additional advantage. © 2012 John Wiley & Sons A/S.

A Tale of Smoking Cessation Promotion: The Utilization of a Children's Book to Increase Screening and Counseling in the Pediatric Clinic.

PubMed

Thomas, Katharine E H; Kisely, Steve; Urrego, Fernando

2017-10-01

The rate at which pediatricians promote smoking cessation in clinical settings is low. The literature demonstrates that interventions paired with tangible health promotion materials may significantly increase screening rates to the pediatric office. The aim of this study was to investigate whether the addition of a children's book in the pediatric clinic could result in an increase in the rate in which pediatricians screened for secondhand smoke exposure (SHSe) and counseled caregivers to stop smoking. This randomized controlled study was performed at 7 pediatric clinics. Seven pediatric clinic sites were randomly assigned to either an intervention or control group. Pediatricians in the intervention group were given children's books about SHSe to distribute to their patients while the control group did not receive any materials. At baseline, there was no difference between the control group and intervention group in rates at which pediatricians screened for SHSe ( P = .8728) and counseled caregivers to stop smoking ( P = .29). After the intervention, screening for SHSe and counseling caregivers to stop smoking were statistically significantly greater in the intervention group, when compared to controls ( P < .01 and P < .001, respectively). The use of a health promotion children's book in the pediatric setting can increase the rate at which pediatricians screen for SHSe and counsel caregivers to stop smoking. Future research should examine the effect of the storybook on various parameters of smoking cessation and future smoking behaviors.

Armored DNA in recombinant Baculoviruses as controls in molecular genetic assays.

PubMed

Freystetter, Andrea; Paar, Christian; Stekel, Herbert; Berg, Jörg

2017-10-01

The widespread use of molecular PCR-based assays in analytical and clinical laboratories brings about the need for test-specific, stable, and reliable external controls (EC) as well as standards and internal amplification controls (IC), in order to arrive at consistent test results. In addition, there is also a growing need to produce and provide stable, well-characterized molecular controls for quality assurance programs. In this study, we describe a novel approach to generate armored double-stranded DNA controls, which are encapsulated in baculovirus (BV) particles of the species Autographa californica multiple nucleopolyhedrovirus. We used the well-known BacPAK™ Baculovirus Expression System (Takara-Clontech), removed the polyhedrin promoter used for protein expression, and generated recombinant BV-armored DNAs. The obtained BV-armored DNAs were readily extracted by standard clinical DNA extraction methods, showed favorable linearity and performance in our clinical PCR assays, were resistant to DNase I digestion, and exhibited marked stability in human plasma and serum. BV-armored DNA ought to be used as ECs, quantification standards, and ICs in molecular assays, with the latter application allowing for the entire monitoring of clinical molecular assays for sample adequacy. BV-armored DNA may also be used to produce double-stranded DNA reference materials for, e.g., quality assurance programs. The ease to produce BV-armored DNA should make this approach feasible for a broad spectrum of molecular applications. Finally, as BV-armored DNAs are non-infectious to mammals, they may be even more conveniently shipped than clinical specimen.

The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial.

PubMed

Kuru, Tuğba; Yeldan, İpek; Dereli, E Elçin; Özdinçler, Arzu R; Dikici, Fatih; Çolak, İlker

2016-02-01

To compare the efficacy of three-dimensional (3D) Schroth exercises in patients with adolescent idiopathic scoliosis. A randomised-controlled study. An outpatient exercise-unit and in a home setting. Fifty-one patients with adolescent idiopathic scoliosis. Forty-five patients with adolescent idiopathic scoliosis meeting the inclusion criteria were divided into three groups. Schroth's 3D exercises were applied to the first group in the clinic and were given as a home program for the second group; the third group was the control. Scoliosis angle (Cobb method), angle of rotation (scoliometer), waist asymmetry (waist - elbow distance), maximum hump height of the patients and quality of life (QoL) (SRS-23) were assessed pre-treatment and, at the 6(th), 12(th) and 24(th) weeks. The Cobb (-2.53°; P=0.003) and rotation angles (-4.23°; P=0.000) significantly decreased, which indicated an improvement in the clinic exercise group compared to the other groups. The gibbosity (-68.66mm; P=0.000) and waist asymmetry improved only in the clinic exercise group, whereas the results of the other groups worsened. QoL did not change significantly in either group. According to the results of this study the Schroth exercise program applied in the clinic under physiotherapist supervision was superior to the home exercise and control groups; additionally, we observed that scoliosis progressed in the control group, which received no treatment. © The Author(s) 2015.

Investigating bang for your training buck: a randomized controlled trial comparing three methods of training clinicians in two core strategies of dialectical behavior therapy.

PubMed

Dimeff, Linda A; Harned, Melanie S; Woodcock, Eric A; Skutch, Julie M; Koerner, Kelly; Linehan, Marsha M

2015-05-01

The present study examined the efficacy of online training (OLT), instructor-led training (ILT), and a treatment manual (TM) in training mental health clinicians in two core strategies of Dialectical Behavior Therapy (DBT): chain analysis and validation. A randomized controlled trial compared OLT, ILT, and TM among clinicians naïve to DBT (N=172) who were assessed at baseline, post-training, and 30, 60, and 90 days following training. Primary outcomes included satisfaction, self-efficacy, motivation, knowledge, clinical proficiency, and clinical use. Overall, ILT outperformed OLT and TM in satisfaction, self-efficacy, and motivation, whereas OLT was the most effective method for increasing knowledge. The conditions did not differ in observer-rated clinical proficiency or self-reported clinical use, which both increased to moderate levels after training. In addition, ILT was particularly effective at improving motivation to use chain analysis, whereas OLT was particularly effective at increasing knowledge of validation strategies. These findings suggest that these types of brief, didactic trainings may be effective methods of increasing knowledge of new treatment strategies, but may not be sufficient to enable clinicians to achieve a high level of clinical use or proficiency. Additional research examining the possible advantages of matching training methods to types of treatment strategies may help to determine a tailored, more effective approach to training clinicians in empirically supported treatments. Copyright © 2015. Published by Elsevier Ltd.

Effectiveness of additional supervised exercises compared with conventional treatment alone in patients with acute lateral ankle sprains: systematic review

PubMed Central

van Ochten, John; Luijsterburg, Pim A J; van Middelkoop, Marienke; Koes, Bart W; Bierma-Zeinstra, Sita M A

2010-01-01

Objective To summarise the effectiveness of adding supervised exercises to conventional treatment compared with conventional treatment alone in patients with acute lateral ankle sprains. Design Systematic review. Data sources Medline, Embase, Cochrane Central Register of Controlled Trials, Cinahl, and reference screening. Study selection Included studies were randomised controlled trials, quasi-randomised controlled trials, or clinical trials. Patients were adolescents or adults with an acute lateral ankle sprain. The treatment options were conventional treatment alone or conventional treatment combined with supervised exercises. Two reviewers independently assessed the risk of bias, and one reviewer extracted data. Because of clinical heterogeneity we analysed the data using a best evidence synthesis. Follow-up was classified as short term (up to two weeks), intermediate (two weeks to three months), and long term (more than three months). Results 11 studies were included. There was limited to moderate evidence to suggest that the addition of supervised exercises to conventional treatment leads to faster and better recovery and a faster return to sport at short term follow-up than conventional treatment alone. In specific populations (athletes, soldiers, and patients with severe injuries) this evidence was restricted to a faster return to work and sport only. There was no strong evidence of effectiveness for any of the outcome measures. Most of the included studies had a high risk of bias, with few having adequate statistical power to detect clinically relevant differences. Conclusion Additional supervised exercises compared with conventional treatment alone have some benefit for recovery and return to sport in patients with ankle sprain, though the evidence is limited or moderate and many studies are subject to bias. PMID:20978065

The effect of a toothpaste containing aloe vera on established gingivitis.

PubMed

Namiranian, Homa; Serino, Giovanni

2012-01-01

The aim of the study was to evaluate the effect of a toothpaste containing high concentrations of Aloe vera on the reduction of plaque and gingivitis in patients attending regular dental care by a dental hygienist. Fifteen subjects participated in this randomized, double-blind, intra-individual and controlled clinical study. Participants were non-smokers, with signs of gingivitis (bleeding index 30%) and no signs of periodontitis. Subjects were followed for three 6-month periods during which they used either their own toothpaste, or an Aloe vera or a control toothpaste. Plaque and gingival indices were recorded atthe start and end of each period. There was a statistically and clinically significant reduction of about 20% of the plaque and gingivitis indices at the end of the clinical trial compared to baseline values, but no differences between the Aloe vera and the control toothpaste. It may be concluded that in patients motivated to improve their oral hygiene habits, the use of a toothpaste containing Aloe Vera showed no additional effect on plaque and gingivitis compared to a control toothpaste.

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

PubMed

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

2009-08-01

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

Tiotropium versus placebo for inadequately controlled asthma: a meta-analysis.

PubMed

Tian, Jing-wei; Chen, Jin-wu; Chen, Rui; Chen, Xin

2014-05-01

This meta-analysis was performed to evaluate the efficacy and safety of the addition of tiotropium to standard treatment regimens for inadequately controlled asthma. A systematic search was made of PubMed, EMBASE, MEDLINE, and CENTRAL databases, and ClinicalTrials.gov, and a hand search of leading respiratory journals. Randomized, double-blind clinical trials on the treatment of inadequately controlled asthma for ≥ 4 weeks with the addition of tiotropium, compared with placebo, were reviewed. Studies were pooled to odds ratio (OR) and weighted mean differences (WMDs), with 95% CI. Six trials met the inclusion criteria. The addition of tiotropium, compared with placebo, significantly improved all spirometric indices, including morning and evening peak expiratory flow (WMD 20.59 L/min, 95% CI 15.36-25.81 L/min, P < .001; and WMD 24.95 L/min, 95% CI 19.22-30.69 L/min, P < .001, respectively), trough and peak FEV1 (WMD 0.13 L, 95% CI 0.09-0.18 L, P < .001; and WMD 0.10 L, 95% CI 0.06-0.14 L, P < .001, respectively), the area under the curve of the first 3 h of FEV1 (WMD 0.13 L, 95% CI 0.08-0.18 L, P < .001), trough and peak FVC (WMD 0.1 L, 95% CI 0.05-0.15 L, P < .001; and WMD 0.08 L, 95% CI 0.04-0.13 L, P < .001, respectively), the area under the curve of the first 3 h of FVC (WMD 0.11 L, 95% CI 0.06-0.15 L, P < .001). The mean change in the 7-point Asthma Control Questionnaire score (WMD -0.12, 95% CI -0.21 to -0.03, P = .01) was markedly lower in tiotropium group, but not clinically important. There were no significant differences in Asthma Quality of Life Questionnaire score (WMD 0.09, 95% CI -0.01 to 0.20, P = .09), night awakenings (WMD 0.00, 95% CI -0.05 to 0.05, P = .99) or rescue medication use (WMD -0.18, 95% CI -0.36 to 0.00, P = .06). No significant increase was noticed in adverse events in the tiotropium group (OR 0.80, 95% CI 0.62-1.03, P = .08). The addition of tiotropium to standard treatment regimens has significantly improved lung function without increasing adverse events in patients with inadequately controlled asthma. Long-term trials are required to assess the effects of the addition of tiotropium on asthma exacerbations and mortality.

Minnesota Impulse Disorders Interview (MIDI): Validation of a structured diagnostic clinical interview for impulse control disorders in an enriched community sample.

PubMed

Chamberlain, Samuel R; Grant, Jon E

2018-07-01

Disorders of impulsivity are common, functionally impairing, and highly relevant across different clinical and research settings. Few structured clinical interviews for the identification and diagnosis of impulse control disorders exist, and none have been validated in a community sample in terms of psychometric properties. The Minnesota Impulse control disorders Interview (MIDI v2.0) was administered to an enriched sample of 293 non-treatment seeking adults aged 18-35 years, recruited using media advertisements in two large US cities. In addition to the MIDI, participants undertook extended clinical interview for other mental disorders, the Barratt impulsiveness questionnaire, and the Padua obsessive-compulsive inventory. The psychometric properties of the MIDI were characterized. In logistic regression, the MIDI showed good concurrent validity against the reference measures (versus gambling disorder interview, p < 0.001; Barratt impulsiveness attentional and non-planning scores p < 0.05), and good discriminant validity versus primarily non-impulsive symptoms, including against anxiety, depression, and obsessive-compulsive symptoms (all p > 0.05). Test re-test reliability was excellent (0.95). The MIDI has good psychometric properties and thus may be a valuable interview tool for clinical and research studies involving impulse control disorders. Further research is needed to better understanding the optimal diagnostic classification and neurobiology of these neglected disorders. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

Vasopressin, cortisol, and catecholamine concentrations in dogs with dilated cardiomyopathy.

PubMed

Tidholm, Anna; Häggström, Jens; Hansson, Kerstin

2005-10-01

To evaluate plasma concentrations and urinary excretion of vasopressin and cortisol and urinary excretion of catecholamines in dogs with dilated cardiomyopathy (DCM). 15 dogs with clinical signs of DCM, 15 dogs with preclinical DCM, and 15 control dogs. Physical examinations, thoracic radiography, ECG, and echocardiography were performed on all dogs. Blood and urine samples were collected. Plasma concentration of vasopressin and the urine cortisol-to-urine creatinine ratio were significantly increased in dogs with clinical signs of DCM and dogs with preclinical DCM, compared with control dogs. Plasma vasopressin concentration was significantly higher in dogs with clinical signs of DCM, compared with dogs with preclinical DCM. Urine vasopressin-to-urine creatinine ratio was significantly increased in dogs with clinical signs of DCM, compared with dogs with preclinical DCM and control dogs. Urine epinephrine-to-urine creatinine ratio and urine norepinephrine-to-urine creatinine ratio were significantly increased in dogs with clinical signs of DCM, compared with control dogs. Plasma concentration of cortisol and urine dopamine-to-urine creatinine ratio did not differ significantly among groups. According to this study, the neuroendocrine pattern is changed in dogs with preclinical DCM. These changes are even more pronounced in dogs with clinical signs of DCM. Analysis of concentrations of vasopressin, cortisol, and catecholamines may aid in identification of the clinical stages of DCM. These findings may also provide a basis for additional studies of the possible beneficial effects of vasopressin antagonists and beta-adrenergic receptor antagonists in the treatment of dogs with congestive heart failure and DCM.

Impact of additional counselling sessions through phone calls on smoking cessation outcomes among smokers in Penang State, Malaysia

PubMed Central

2014-01-01

Background Studies all over the world reported that smoking relapses occur during the first two weeks after a quit date. The current study aimed to assess the impact of the additional phone calls counselling during the first month on the abstinence rate at 3 and 6 months after quit date among smokers in Penang, Malaysia. Methods The study was conducted at Quit Smoking Clinic of two major hospitals in Penang, Malaysia. All the eligible smokers who attended the clinics between February 1st and October 31st 2012 were invited. Participants were randomly assigned by using urn design method either to receive the usual care that followed in the clinics (control) or the usual care procedure plus extra counselling sessions through phone calls during the first month of quit attempt (intervention). Results Participants in our cohort smoked about 14 cigarettes per day on average (mean = 13.78 ± 7.0). At 3 months, control group was less likely to quit smoking compared to intervention group (36.9% vs. 46.7%, verified smoking status) but this did not reach statistical significance (OR = 0.669; 95% CI = 0.395-1.133, P = 0.86). However, at 6 months, 71.7% of the intervention group were successfully quit smoking (bio-chemically verified) compared to 48.6% of the control group (P < 0.001). The control group were significantly less likely to quit smoking (OR = 0.375; 95% CI = 0.217-0.645, P < 0.001). Conclusions Smoking cessation intervention consisting of phone calls counselling delivered during the first month of quit attempt revealed significantly higher abstinence rates compared with a standard care approach. Therefore, the additional counselling in the first few weeks after stop smoking is a promising treatment strategy that should be evaluated further. Trial registration TCTR20140504001 PMID:24886549

[Fibromyalgia in men and women: comparison of the main clinical symptoms].

PubMed

Miró, Elena; Diener, Fabián N; Martínez, Ma Pilar; Sánchez, Ana I; Valenza, Marie Carmen

2012-02-01

The prevalence of fibromyalgia (FM) in males is much lower than in women. Thus, current knowledge about the syndrome has been developed from research with women. The aim of the present study is to analyze whether FM manifestations differ as a function of sex. Two clinical groups with FM (21 males and 21 women) and a control group of healthy men (n= 21) participated in the study. Several aspects of pain, sleep, fatigue, psychopathology, emotional distress and functional impact of FM were evaluated with an algometer and questionnaires. The clinical groups showed a significantly greater impairment than the control group in all the self-report measures. However, the FM patients only showed significant differences in the sensibility threshold to the pain, which was lower in the women. In addition, the best predictor of the experience of pain in males was sleep quality, and in the women, catastrofying pain. Our results suggest that the most effective therapeutic strategies to control pain may be different for men and women.

[Clinical efficacy of mouse nerve growth factor in treatment of occupational hand-arm vibration disease].

PubMed

Fan, Chunyue; Wang, Yanyan; Zhang, Ying; Lang, Li; Deng, Xiaofeng; Cheng, Ying

2014-12-01

To investigate the efficacy of mouse nerve growth factor (mNGF) in treating occupational hand-arm vibration disease (HAVD). Sixty-four patients with HAVD were equally and randomly divided into treatment group and control group. The control group was given Salvia miltiorrhiza Bunge and deproteinized extract of calf blood to improve circulation, and also given methylcobalamin tablets and vitamin B6 for neurotrophic treatment. In addition to the above treatments for the control group, the treatment group was also given 30 µg/d mNGF by intramuscular injection for two courses (4 weeks for each course) with a 15-day interval. Both the treatment group and the control group showed significant improvements in clinical symptoms and signs (hand numbness and pain, and reduced senses of touch, pain, and vibration), cold water loading test (CWLT), and electroneuromyography (ENMG) after treatments (P < 0.05). And the treatment group had significantly more improvements than the control group (P < 0.05). mNGF can significantly improve hand numbness and pain, reduced senses of touch, pain, and vibration, CWLT, and ENMG, so it has better clinical effect and safety in treating HAVD. Early diagnosis and treatment can improve the outcome of patients with HAVD.

3D Metal Printing - Additive Manufacturing Technologies for Frameworks of Implant-Borne Fixed Dental Prosthesis.

PubMed

Revilla León, M; Klemm, I M; García-Arranz, J; Özcan, M

2017-09-01

An edentulous patient was rehabilitated with maxillary metal-ceramic and mandibular metal-resin implant-supported fixed dental prosthesis (FDP). Metal frameworks of the FDPs were fabricated using 3D additive manufacturing technologies utilizing selective laser melting (SLM) and electron beam melting (EBM) processes. Both SLM and EBM technologies were employed in combination with computer numerical control (CNC) post-machining at the implant interface. This report highlights the technical and clinical protocol for fabrication of FDPs using SLM and EBM additive technologies. Copyright© 2017 Dennis Barber Ltd.

Inhaler Reminders Significantly Improve Asthma Patients' Use of Controller Medications

MedlinePlus

... Menu Search Main navigation Skip to content Conditions & Treatments Allergies Asthma Primary Immunodeficiency Disease Related Conditions Drug Guide ... the most-cited journal in the field of allergy and clinical immunology. Additional Information Asthma Symptoms, Diagnosis, ... Utility navigation Donate Annual meeting Browse your ...

Efficacy of Cruise Control in controlling postocclusion surge with Legacy and Millennium venturi phacoemulsification machines.

PubMed

Wade, Matthew; Isom, Ryan; Georgescu, Dan; Olson, Randall J

2007-06-01

To determine the efficacy of the Cruise Control surge-limiting device (Staar Surgical) with phacoemulsification machines known to have high levels of surge. John A. Moran Eye Center Clinical Laboratories. In an in vitro study, postocclusion anterior chamber depth changes were measured in fresh phakic human eye-bank eyes using the Alcon Legacy and Bausch & Lomb Millennium venturi machines in conjunction with the Staar Cruise Control device. Both machines were tested with 19-gauge non-Aspiration Bypass System tips at high-surge settings (500 mm Hg vacuum pressure, 75 cm bottle height, 40 mL/min flow rate for the Legacy) and low-surge settings (400 mm Hg vacuum pressure, 125 cm bottle height, 40 mL/min flow rate for the Legacy). Adjusted parameters of flow, vacuum, and irrigation were used based on previous studies to create identical conditions for each device tested. The effect of the Cruise Control device on aspiration rates was also tested with both machines at the low-surge settings. At the high setting with the addition of Cruise Control, surge decreased significantly with the Legacy but was too large to measure with the Millennium venturi. At the low setting with the addition of Cruise Control, surge decreased significantly with both machines. Surge with the Millennium decreased from more than 1.0 mm to a mean of 0.21 mm +/- 0.02 (SD) (P<.0001). Surge with the Legacy decreased from a mean of 0.09 +/- 0.02 mm to 0.05 +/- 0 mm, a 42.9% decrease (P<.0001). The Millennium had the highest surge and aspiration rate before Cruise Control and the greatest percentage decrease in the surge and aspiration rates as a result of the addition of Cruise Control. In the Legacy machine, the Cruise Control device had a statistically and clinically significant effect. Cruise Control had a large effect on fluidics as well as surge amplitude with the Millennium machine. The greater the flow or greater the initial surge, the greater the impact of the Cruise Control device.

Exposure reduces negative bias in self-rated performance in public speaking fearful participants.

PubMed

Cheng, Joyce; Niles, Andrea N; Craske, Michelle G

2017-03-01

Individuals with public speaking anxiety (PSA) under-rate their performance compared to objective observers. The present study examined whether exposure reduces the discrepancy between self and observer performance ratings and improved observer-rated performance in individuals with PSA. PSA participants gave a speech in front of a small audience and rated their performance using a questionnaire before and after completing repeated exposures to public speaking. Non-anxious control participants gave a speech and completed the questionnaire one time only. Objective observers watched videos of the speeches and rated performance using the same questionnaire. PSA participants underrated their performance to a greater degree than did controls prior to exposure, but also performed significantly more poorly than did controls when rated objectively. Bias significantly decreased and objective-rated performance significantly increased following completion of exposure in PSA participants, and on one performance measure, anxious participants no longer showed a greater discrepancy between self and observer performance ratings compared to controls. The study employed non-clinical student sample, but the results should be replicated in clinical anxiety samples. These findings indicate that exposure alone significantly reduces negative performance bias among PSA individuals, but additional exposure or additional interventions may be necessary to fully correct bias and performance deficits. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. I. Main results of the studies].

PubMed

Jermendy, György

2018-04-01

The effect of antihyperglycaemic (antidiabetic) treatment on the late diabetic complications is one of the most important research areas in clinical diabetology. The relationship between glycaemic control and late micro- and macrovascular complications was highlighted by the results of the DCCT (Diabetes Control and Complications Trial) with type 1 and by the UKPDS (United Kingdom Prospective Diabetes Study) with type 2 diabetic patients. In these studies, observational follow-up investigations were also performed after the close-out of the randomized phase of the trial. In addition to these landmark studies, other randomized, controlled efficacy trials were also performed with observational follow-up investigations resulting in the development of the concept of metabolic memory or metabolic legacy. In this article, the main results of the studies are summarized. Orv Hetil. 2018; 159(15): 575-582.

Clinical trial design for orthodontists.

PubMed

Pandis, Nikolaos; Cobourne, Martyn T

2013-06-01

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

Noninvasive ventilation.

PubMed

Rabatin, J T; Gay, P C

1999-08-01

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

The association between depressive disorder and cardiac autonomic control in adults 60 years and older.

PubMed

Licht, Carmilla M M; Naarding, Paul; Penninx, Brenda W J H; van der Mast, Roos C; de Geus, Eco J C; Comijs, Hannie

2015-04-01

Altered cardiac autonomic control has often been reported in depressed persons and might play an important role in the increased risk for cardiovascular disease (CVD). A negative association between cardiac autonomic control and depression might become specifically clinically relevant in persons 60 years or older as CVD risk increases with age. This study included data of 321 persons with a depressive disorder and 115 controls participating in the Netherlands Study of Depression in Older Persons (mean age = 70.3 years, 65.7% female). Respiratory sinus arrhythmia (RSA), heart rate (HR), and preejection period (PEP) were measured and compared between depressed persons and controls. In addition, the role of antidepressants and clinical characteristics (e.g., age of depression onset and comorbid anxiety) was examined. Compared with controls, depressed persons had lower RSA (mean [standard error of the mean] = 23.5 [1.2] milliseconds versus 18.6 [0.7] milliseconds, p = .001, d = 0.373) and marginally higher HR (73.1 [1.1] beats/min versus 75.6 [0.6] beats/min, p = .065, d = 0.212), but comparable PEP (113.9 [2.1] milliseconds versus 112.0 [1.2] milliseconds, p = .45, d = 0.087), fully adjusted. Antidepressants strongly attenuated the associations between depression and HR and RSA. Antidepressant-naïve depressed persons had similar HR and RSA to controls, whereas users of antidepressants showed significantly lower RSA. In addition, tricyclic antidepressant users had higher HR (p < .001, d = 0.768) and shorter PEP (p = .014, d = 0.395) than did controls. Depression was not associated with cardiac autonomic control, but antidepressants were in this sample. All antidepressants were associated with low cardiac parasympathetic control and specifically tricyclic antidepressants with high cardiac sympathetic control.

Polygenic dissection of diagnosis and clinical dimensions of bipolar disorder and schizophrenia.

PubMed

Ruderfer, Douglas M; Fanous, Ayman H; Ripke, Stephan; McQuillin, Andrew; Amdur, Richard L; Gejman, Pablo V; O'Donovan, Michael C; Andreassen, Ole A; Djurovic, Srdjan; Hultman, Christina M; Kelsoe, John R; Jamain, Stephane; Landén, Mikael; Leboyer, Marion; Nimgaonkar, Vishwajit; Nurnberger, John; Smoller, Jordan W; Craddock, Nick; Corvin, Aiden; Sullivan, Patrick F; Holmans, Peter; Sklar, Pamela; Kendler, Kenneth S

2014-09-01

Bipolar disorder and schizophrenia are two often severe disorders with high heritabilities. Recent studies have demonstrated a large overlap of genetic risk loci between these disorders but diagnostic and molecular distinctions still remain. Here, we perform a combined genome-wide association study (GWAS) of 19 779 bipolar disorder (BP) and schizophrenia (SCZ) cases versus 19 423 controls, in addition to a direct comparison GWAS of 7129 SCZ cases versus 9252 BP cases. In our case-control analysis, we identify five previously identified regions reaching genome-wide significance (CACNA1C, IFI44L, MHC, TRANK1 and MAD1L1) and a novel locus near PIK3C2A. We create a polygenic risk score that is significantly different between BP and SCZ and show a significant correlation between a BP polygenic risk score and the clinical dimension of mania in SCZ patients. Our results indicate that first, combining diseases with similar genetic risk profiles improves power to detect shared risk loci and second, that future direct comparisons of BP and SCZ are likely to identify loci with significant differential effects. Identifying these loci should aid in the fundamental understanding of how these diseases differ biologically. These findings also indicate that combining clinical symptom dimensions and polygenic signatures could provide additional information that may someday be used clinically.

Cognitive deficits in amyotrophic lateral sclerosis evaluated by event-related potentials.

PubMed

Ogawa, Tomohiro; Tanaka, Hideaki; Hirata, Koichi

2009-04-01

To determine the cognitive profiles in non-demented, relatively less handicapped patients with early-stage sporadic amyotrophic lateral sclerosis (ALS) by using neuropsychological tests, event-related potentials (ERPs) and clinical scale. We recruited 19 patients with sporadic ALS (eight with limb-onset, 11 with bulbar-onset) and 19 controls. In addition to the mini-mental state examination and the Wechsler adult intelligence scale-revised, we assessed the frontal lobe function with Wisconsin card sorting test, Stroop test and trail making test. We used auditory 'oddball' counting paradigm for the ERPs under 20-channel electroencephalogram (EEG) recording. Global field power (GFP) was computed, and its peak amplitudes and latencies of N1/N2/P3 were determined. The results of ERP and neuropsychological tests were correlated with respiratory function and clinical scale. No global cognitive impairment except for subtle frontal dysfunction was detected, although N1/N2/P3 GFP latencies were significantly prolonged in ALS patients than in the controls. Vital capacity correlated with P3 GFP amplitude, and the relative bulbar functional rating scale correlated with P3 GFP latency. Our findings indicated the presence of sub-clinical cognitive deficits in non-demented, sporadic ALS patients. In addition, clinical sub-types and respiratory function dependently influenced cognitive function in patients with sporadic ALS. ERP confirmed cognitive impairment in patients with sporadic ALS.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes.

PubMed

Taylor, Nicholas F; Brusco, Natasha K; Watts, Jennifer J; Shields, Nora; Peiris, Casey; Sullivan, Natalie; Kennedy, Genevieve; Teo, Cheng Kwong; Farley, Allison; Lockwood, Kylee; Radia-George, Camilla

2010-11-12

Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Australian and New Zealand Clinical Trials Registry ACTRN12609000973213.

Out of sight, out of mind? Does terminating the physical presence of a geriatric consultant in the community clinic reduce the implementation rate for geriatric recommendations.

PubMed

Freud, Tamar; Punchik, Boris; Biderman, Aya; Peleg, Roni; Kagan, Ella; Barzak, Alex; Press, Yan

2016-01-01

To assess the effect of moving the geriatric consultation from the primary care clinic to another setting, on the rate of implementation of geriatric recommendations by family physicians. A retrospective review of the computerized medical records of elderly patients in four primary care clinics. The rate of implementation of geriatric recommendations was compared between clinics in which a geriatric consultant was physically present (control clinics) and a clinic where the consultation took place elsewhere (study clinic). In addition, the results of the present study were compared to a previous study in which the geriatric consultation was carried out in the study clinic and the family doctor was an active participant. 127 computerized files were reviewed in the study clinic and 133 in the control clinics. The mean age of the patients was 81.1±6.3 years and 63.1% were women. The overall implementation of geriatric recommendations by family doctors in the study clinic was 55.9%, a statistically significant decrease compared to the previous study where the rate was 73.9% (p<0.0001). In contrast, there was no change in the implementation rate in the control clinics at 65.0% in the present study and 59.9% in the previous one (p=0.205). Direct, person-to-person contact between the geriatric consultant and the family doctor has a beneficial effect on the implementation of geriatric recommendations. This should be considered by healthcare policy makers when planning geriatric services in the community. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Opioid-Sparing Effect of Cannabinoids: A Systematic Review and Meta-Analysis.

PubMed

Nielsen, Suzanne; Sabioni, Pamela; Trigo, Jose M; Ware, Mark A; Betz-Stablein, Brigid D; Murnion, Bridin; Lintzeris, Nicholas; Khor, Kok Eng; Farrell, Michael; Smith, Andrew; Le Foll, Bernard

2017-08-01

Cannabinoids, when co-administered with opioids, may enable reduced opioid doses without loss of analgesic efficacy (ie, an opioid-sparing effect). The aim of this study was to conduct a systematic review to determine the opioid-sparing potential of cannabinoids. Eligible studies included pre-clinical and clinical studies for which the outcome was either analgesia or opioid dose requirements. Clinical studies included controlled studies and case series. We searched Scopus, Cochrane Database of Systematic Reviews, Medline, and Embase. Nineteen pre-clinical and nine clinical studies met the search criteria. Seventeen of the 19 pre-clinical studies provided evidence of synergistic effects from opioid and cannabinoid co-administration. Our meta-analysis of pre-clinical studies indicated that the median effective dose (ED 50 ) of morphine administered in combination with delta-9-tetrahydrocannabinol (delta-9-THC) is 3.6 times lower (95% confidence interval (CI) 1.95, 6.76; n=6) than the ED 50 of morphine alone. In addition, the ED 50 for codeine administered in combination with delta-9-THC was 9.5 times lower (95% CI 1.6, 57.5, n=2) than the ED 50 of codeine alone. One case series (n=3) provided very-low-quality evidence of a reduction in opioid requirements with cannabinoid co-administration. Larger controlled clinical studies showed some clinical benefits of cannabinoids; however, opioid dose changes were rarely reported and mixed findings were observed for analgesia. In summary, pre-clinical studies provide robust evidence of the opioid-sparing effect of cannabinoids, whereas one of the nine clinical studies identified provided very-low-quality evidence of such an effect. Prospective high-quality-controlled clinical trials are required to determine the opioid-sparing effect of cannabinoids.

Robot-supported upper limb training in a virtual learning environment : a pilot randomized controlled trial in persons with MS.

PubMed

Feys, Peter; Coninx, Karin; Kerkhofs, Lore; De Weyer, Tom; Truyens, Veronik; Maris, Anneleen; Lamers, Ilse

2015-07-23

Despite the functional impact of upper limb dysfunction in multiple sclerosis (MS), effects of intensive exercise programs and specifically robot-supported training have been rarely investigated in persons with advanced MS. To investigate the effects of additional robot-supported upper limb training in persons with MS compared to conventional treatment only. Seventeen persons with MS (pwMS) (median Expanded Disability Status Scale of 8, range 3.5-8.5) were included in a pilot RCT comparing the effects of additional robot-supported training to conventional treatment only. Additional training consisted of 3 weekly sessions of 30 min interacting with the HapticMaster robot within an individualised virtual learning environment (I-TRAVLE). Clinical measures at body function (Hand grip strength, Motricity Index, Fugl-Meyer) and activity (Action Research Arm test, Motor Activity Log) level were administered before and after an intervention period of 8 weeks. The intervention group were also evaluated on robot-mediated movement tasks in three dimensions, providing active range of motion, movement duration and speed and hand-path ratio as indication of movement efficiency in the spatial domain. Non-parametric statistics were applied. PwMS commented favourably on the robot-supported virtual learning environment and reported functional training effects in daily life. Movement tasks in three dimensions, measured with the robot, were performed in less time and for the transporting and reaching movement tasks more efficiently. There were however no significant changes for any clinical measure in neither intervention nor control group although observational analyses of the included cases indicated large improvements on the Fugl-Meyer in persons with more marked upper limb dysfunction. Robot-supported training lead to more efficient movement execution which was however, on group level, not reflected by significant changes on standard clinical tests. Persons with more marked upper limb dysfunction may benefit most from additional robot-supported training, but larger studies are needed. This trial is registered within the registry Clinical Trials GOV ( NCT02257606 ).

ICMR programme on Antibiotic Stewardship, Prevention of Infection & Control (ASPIC).

PubMed

Chandy, Sujith J; Michael, Joy Sarojini; Veeraraghavan, Balaji; Abraham, O C; Bachhav, Sagar S; Kshirsagar, Nilima A

2014-02-01

Antimicrobial resistance and hospital infections have increased alarmingly in India. Antibiotic stewardship and hospital infection control are two broad strategies which have been employed globally to contain the problems of resistance and infections. For this to succeed, it is important to bring on board the various stakeholders in hospitals, especially the clinical pharmacologists. The discipline of clinical pharmacology needs to be involved in themes such as antimicrobial resistance and hospital infection which truly impact patient care. Clinical pharmacologists need to collaborate with faculty in other disciplines such as microbiology to achieve good outcomes for optimal patient care in the hospital setting. The ASPIC programme was initiated by the Indian Council of Medical Research (ICMR) in response to the above need and was designed to bring together faculty from clinical pharmacology, microbiology and other disciplines to collaborate on initiating and improving antibiotic stewardship and concurrently curbing hospital infections through feasible infection control practices. This programme involves the participation of 20 centres per year throughout the country which come together for a training workshop. Topics pertaining to the above areas are discussed in addition to planning a project which helps to improve antibiotic stewardship and infection control practices in the various centres. It is hoped that this programme would empower hospitals and institutions throughout the country to improve antibiotic stewardship and infection control and ultimately contain antimicrobial resistance.

Clinical trials in male hormonal contraception.

PubMed

Nieschlag, Eberhard

2010-11-01

Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers. Copyright © 2010 Elsevier Inc. All rights reserved.

Development and Characterization of Reference Materials for Genetic Testing: Focus on Public Partnerships.

PubMed

Kalman, Lisa V; Datta, Vivekananda; Williams, Mickey; Zook, Justin M; Salit, Marc L; Han, Jin Yeong

2016-11-01

Characterized reference materials (RMs) are needed for clinical laboratory test development and validation, quality control procedures, and proficiency testing to assure their quality. In this article, we review the development and characterization of RMs for clinical molecular genetic tests. We describe various types of RMs and how to access and utilize them, especially focusing on the Genetic Testing Reference Materials Coordination Program (Get-RM) and the Genome in a Bottle (GIAB) Consortium. This review also reinforces the need for collaborative efforts in the clinical genetic testing community to develop additional RMs.

The relationship between clinical characteristics, metacognitive appraisals, and cognitive insight in patients with obsessive-compulsive disorder.

PubMed

Ekinci, Okan; Ekinci, Asli

2016-11-01

Cognitive insight, a recently developed insight measure, refers to metacognitive processes of the re-evaluation and correction of distorted beliefs and misinterpretations. However, to the best of the authors' knowledge, no study has specifically examined cognitive insight, demographics, psychopathological variables, and distorted beliefs in OCD. The aim of this research was to examine links between cognitive insight and demographics, clinical factors, and distorted beliefs among patients with OCD. Eighty-four consecutive outpatients with a diagnosis of OCD underwent a detailed clinical assessment for OCD, including the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), Beck Cognitive Insight Scale (BCIS), Thought-Action Fusion Scale (TAFS), White Bear Thought Suppression Inventory, Metacognition Questioniarre-30 (MCQ-30), and a sociodemographic questionnaire. In addition, 82 control subjects matched for age, education, and gender were tested. BCIS-self-certainty scores were all substantially higher in subjects with remitted and unremitted OCD than in healthy comparison subjects, while BCIS-composite scores were significantly lower in both patient groups than controls. Obsession and compulsion severity had significant effects on BCIS scores. In addition, it was found that the specific symptoms were linked to self-certainty scores. Self-reflectiveness and composite scores had positive correlations with the sub-scale scores of the MCQ-30, while the TAF-morality score was positively correlated with self-certainty scores. The results demonstrated poor cognitive insight among remitted and unremitted OCD patients. In addition, the present study suggested significant associations between sociodemographic and clinical features and dysfunctional appraisals. Cognitive-behavioural techniques aimed at enhancing cognitive insight may be beneficial for patients with OCD, particularly patients who have prominent dysfunctional beliefs.

Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial.

PubMed

Jensen, Cathrine Elgaard; Riis, Allan; Pedersen, Kjeld Møller; Jensen, Martin Bach; Petersen, Karin Dam

2014-10-08

In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation. The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon. It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective. ClinicalTrials.gov: NCT01699256.

Periodontal regeneration around natural teeth.

PubMed

Garrett, S

1996-11-01

1. Evidence is conclusive (Table 2) that periodontal regeneration in humans is possible following the use of bone grafts, guided tissue regeneration procedures, both without and in combination with bone grafts, and root demineralization procedures. 2. Clinically guided tissue regeneration procedures have demonstrated significant positive clinical change beyond that achieved with debridement alone in treating mandibular and maxillary (buccal only) Class II furcations. Similar data exist for intraosseous defects. Evidence suggests that the use of bone grafts or GTR procedures produce equal clinical benefit in treating intraosseous defects. Further research is necessary to evaluate GTR procedures compared to, or combined with, bone grafts in treating intraosseous defects. 3. Although there are some data suggesting hopeful results in Class II furcations, the clinical advantage of procedures combining present regenerative techniques remains to be demonstrated. Additional randomized controlled trials with sufficient power are needed to demonstrate the potential usefulness of these techniques. 4. Outcomes following regenerative attempts remain somewhat variable with differences in results between studies and individual subjects. Some of this variability is likely patient related in terms of compliance with plaque control and maintenance procedures, as well as personal habits; e.g., smoking. Variations in the defects selected for study may also affect predictability of outcomes along with other factors. 5. There is evidence to suggest that present regenerative techniques lead to significant amounts of regeneration at localized sites on specific teeth. However, if complete regeneration is to become a reality, additional stimuli to enhance the regenerative process are likely needed. Perhaps this will be accomplished in the future, with combined procedures that include appropriate polypeptide growth factors or tissue factors to provide additional stimulus.

To Assess the Association between Glucose Metabolism and Ectopic Lipid Content in Different Clinical Classifications of PCOS.

PubMed

Göbl, Christian S; Ott, Johannes; Bozkurt, Latife; Feichtinger, Michael; Rehmann, Victoria; Cserjan, Anna; Heinisch, Maike; Steinbrecher, Helmut; JustKukurova, Ivica; Tuskova, Radka; Leutner, Michael; Vytiska-Binstorfer, Elisabeth; Kurz, Christine; Weghofer, Andrea; Tura, Andrea; Egarter, Christian; Kautzky-Willer, Alexandra

2016-01-01

There are emerging data indicating an association between PCOS (polycystic ovary syndrome) and metabolic derangements with potential impact on its clinical presentation. This study aims to evaluate the pathophysiological processes beyond PCOS with particular focus on carbohydrate metabolism, ectopic lipids and their possible interaction. Differences between the two established classifications of the disease should be additionally evaluated. A metabolic characterization was performed in 53 untreated PCOS patients as well as 20 controls including an extended oral glucose tolerance test (OGTT, to assess insulin sensitivity, secretion and ß-cell function) in addition to a detailed examination of ectopic lipid content in muscle and liver by nuclear magnetic resonance spectroscopy. Women with PCOS classified by the original NIH 1990 definition showed a more adverse metabolic risk profile compared to women characterized by the additional Rotterdam 2003 phenotypes. Subtle metabolic derangements were observed in both subgroups, including altered shapes of OGTT curves, impaired insulin action and hyperinsulinemia due to increased secretion and attenuated hepatic extraction. No differences were observed for ectopic lipids between the groups. However, particularly hepatocellular lipid content was significantly related to clinical parameters of PCOS like whole body insulin sensitivity, dyslipidemia and free androgen index. Subtle alterations in carbohydrate metabolism are present in both PCOS classifications, but more profound in subjects meeting the NIH 1990 criteria. Females with PCOS and controls did not differ in ectopic lipids, however, liver fat was tightly related to hyperandrogenism and an adverse metabolic risk profile.

Amelogenin test: From forensics to quality control in clinical and biochemical genomics.

PubMed

Francès, F; Portolés, O; González, J I; Coltell, O; Verdú, F; Castelló, A; Corella, D

2007-01-01

The increasing number of samples from the biomedical genetic studies and the number of centers participating in the same involves increasing risk of mistakes in the different sample handling stages. We have evaluated the usefulness of the amelogenin test for quality control in sample identification. Amelogenin test (frequently used in forensics) was undertaken on 1224 individuals participating in a biomedical study. Concordance between referred sex in the database and amelogenin test was estimated. Additional sex-error genetic detecting systems were developed. The overall concordance rate was 99.84% (1222/1224). Two samples showed a female amelogenin test outcome, being codified as males in the database. The first, after checking sex-specific biochemical and clinical profile data was found to be due to a codification error in the database. In the second, after checking the database, no apparent error was discovered because a correct male profile was found. False negatives in amelogenin male sex determination were discarded by additional tests, and feminine sex was confirmed. A sample labeling error was revealed after a new DNA extraction. The amelogenin test is a useful quality control tool for detecting sex-identification errors in large genomic studies, and can contribute to increase its validity.

Effects of adding alendronate to ongoing hormone therapy on bone mineral density in postmenopausal Korean women: a randomized, double-blind, placebo-controlled clinical trial.

PubMed

Min, Yong-Ki; Lee, Dong-Yun; Choi, Suk-Joo; Kim, Joo Han; Choi, DooSeok; Yoon, Byung-Koo

2013-07-01

This study was conducted to evaluate the effects of adding the bisphosphonate alendronate (ALEN) to ongoing hormone therapy (HT) on bone mineral density (BMD) in postmenopausal Korean women. This randomized, double-blind, placebo-controlled clinical trial at a university hospital included a total of 139 postmenopausal women who had low BMD after HT lasting at least 1 year. Women received either ALEN (10 mg/d) or placebo in combination with HT for 1 year. Changes in BMD and biochemical markers of bone turnover were evaluated. Lumbar spine and total hip BMDs increased significantly in both treatment groups after 1 year. The addition of ALEN, when compared with HT alone, did not produce a significant change in BMD at the lumbar spine (3.7% vs 4.3%) and total hip (2.2% vs 3.2%) after adjusting for controllable variables. Serum osteocalcin showed a similar change, but urinary deoxypyridinoline response differed between treatment groups. Compared with HT alone, the addition of ALEN to ongoing HT for 1 year does not make a difference in BMD among postmenopausal Korean women with low BMD.

Cost-effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts: economic evaluation alongside a randomised controlled trial (EVerT trial)

PubMed Central

2012-01-01

Abstract Background Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151. PMID:22369511

White Matter Microstructural Abnormalities in Type 2 Diabetes Mellitus: A Diffusional Kurtosis Imaging Analysis.

PubMed

Xie, Y; Zhang, Y; Qin, W; Lu, S; Ni, C; Zhang, Q

2017-03-01

Increasing DTI studies have demonstrated that white matter microstructural abnormalities play an important role in type 2 diabetes mellitus-related cognitive impairment. In this study, the diffusional kurtosis imaging method was used to investigate WM microstructural alterations in patients with type 2 diabetes mellitus and to detect associations between diffusional kurtosis imaging metrics and clinical/cognitive measurements. Diffusional kurtosis imaging and cognitive assessments were performed on 58 patients with type 2 diabetes mellitus and 58 controls. Voxel-based intergroup comparisons of diffusional kurtosis imaging metrics were conducted, and ROI-based intergroup comparisons were further performed. Correlations between the diffusional kurtosis imaging metrics and cognitive/clinical measurements were assessed after controlling for age, sex, and education in both patients and controls. Altered diffusion metrics were observed in the corpus callosum, the bilateral frontal WM, the right superior temporal WM, the left external capsule, and the pons in patients with type 2 diabetes mellitus compared with controls. The splenium of the corpus callosum and the pons had abnormal kurtosis metrics in patients with type 2 diabetes mellitus. Additionally, altered diffusion metrics in the right prefrontal WM were significantly correlated with disease duration and attention task performance in patients with type 2 diabetes mellitus. With both conventional diffusion and additional kurtosis metrics, diffusional kurtosis imaging can provide additional information on WM microstructural abnormalities in patients with type 2 diabetes mellitus. Our results indicate that WM microstructural abnormalities occur before cognitive decline and may be used as neuroimaging markers for predicting the early cognitive impairment in patients with type 2 diabetes mellitus. © 2017 by American Journal of Neuroradiology.

The topical 5% lidocaine medicated plaster in localized neuropathic pain: a reappraisal of the clinical evidence

PubMed Central

de León-Casasola, Oscar A; Mayoral, Victor

2016-01-01

Topical 5% lidocaine medicated plasters represent a well-established first-line option for the treatment of peripheral localized neuropathic pain (LNP). This review provides an updated overview of the clinical evidence (randomized, controlled, and open-label clinical studies, real-life daily clinical practice, and case series). The 5% lidocaine medicated plaster effectively provides pain relief in postherpetic neuralgia, and data from a large open-label controlled study indicate that the 5% lidocaine medicated plaster is as effective as systemic pregabalin in postherpetic neuralgia and painful diabetic polyneuropathy but with an improved tolerability profile. Additionally, improved analgesia and fewer side effects were experienced by patients treated synchronously with the 5% lidocaine medicated plaster, further demonstrating the value of multimodal analgesia in LNP. The 5% lidocaine medicated plaster provides continued benefit after long-term (≤7 years) use and is also effective in various other LNP conditions. Minor application-site reactions are the most common adverse events associated with the 5% lidocaine medicated plaster; there is minimal risk of systemic adverse events and drug–drug interactions. Although further well-controlled studies are warranted, the 5% lidocaine medicated plaster is efficacious and safe in LNP and may have particular clinical benefit in elderly and/or medically compromised patients because of the low incidence of adverse events. PMID:26929664

Diabetes quality improvement in Department of Veterans Affairs Ambulatory Care Clinics: a group-randomized clinical trial.

PubMed

Reiber, Gayle E; Au, David; McDonell, Mary; Fihn, Stephan D

2004-05-01

To conduct a group-randomized clinical trial to determine whether regular feedback to primary care providers of synthesized information on patients' health, function, and satisfaction would demonstrate improved outcomes for their patients with diabetes. Patients in General Internal Medicine Clinics Department of Veterans Affairs (VA) Medical Centers were randomized into seven intervention or control firms. Patient self-reported information was collected by mail on general health, diabetes, and up to five other chronic conditions. Patients with diabetes received the Seattle Diabetes Questionnaire, the 36-item Medical Outcomes Study short form (SF-36), and a validated patient satisfaction questionnaire at regular intervals. Data from self-report, clinical, pharmacy, and laboratory sources were synthesized into patient-specific feedback reports that intervention providers received before patients' visits. The timely delivery to primary care providers of state-of-the-art patient-feedback reports that identified patient issues and areas for improvement did not result in significant improvements in patient outcomes between the intervention and control firms. Outcomes in diabetic patients whose providers received synthesized patient data before visits were no better than in those receiving care from control firms. Future studies may benefit from substantial involvement in patients discussing, problem solving, and goal setting in addition to use of timely synthesized patient data.

A comparative, randomized, controlled study on clinical efficacy and dental staining reduction of a mouthwash containing Chlorhexidine 0.20% and Anti Discoloration System (ADS).

PubMed

Marrelli, Massimo; Amantea, Massimiliano; Tatullo, Marco

2015-01-01

A good control of bacterial plaque is an essential factor for the success of periodontal therapy, therefore it is the main objective that the clinician together with the patient must get to have a healthy periodontium. The plaque control with mouthwashes is the most important home therapy as it helps to reduce the formation of plaque between the mechanical removal with a toothbrush. Authors analyzed the clinical data from a trial carried out with 3 different mouthwashes containing 0.2% Chlorhexidine (CHX). In addition, the ADS (Anti Discoloration System - Curaden Healthcare) was tested in comparison with the other mouthwashes without this system. We tested antiplaque activity showed by 3 of the most commercialized mouthwashes, moreover, we tested the ability in reducing the dental staining related to the oral assumption of Chlorhexidine. Our results demonstrated the clinical efficacy of the 3 mouthwashes with CHX. Particularly performing was the anti discoloration system (Curaden Healthcare), with a clinical detection of dental stainings significantly less than the others tested. This study demonstrated the clinical efficacy of ADS system in the reduction of tooth staining, without a loss of antiplaque activity with respect to the competing mouthwashes containing CHX.

Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

PubMed

Sennerby, L; Gottlow, J

2008-06-01

Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

Conjugated Equine Estrogens and Breast Cancer Risk in the Women’s Health Initiative Clinical Trial and Observational Study

PubMed Central

Prentice, Ross L.; Chlebowski, Rowan T.; Stefanick, Marcia L.; Manson, JoAnn E.; Langer, Robert D.; Pettinger, Mary; Hendrix, Susan L.; Hubbell, F. Allan; Kooperberg, Charles; Kuller, Lewis H.; Lane, Dorothy S.; McTiernan, Anne; O’Sullivan, Mary Jo; Rossouw, Jacques E.; Anderson, Garnet L.

2009-01-01

The Women’s Health Initiative randomized controlled trial found a trend (p = 0.09) toward a lower breast cancer risk among women assigned to daily 0.625-mg conjugated equine estrogens (CEEs) compared with placebo, in contrast to an observational literature that mostly reports a moderate increase in risk with estrogenalone preparations. In 1993–2004 at 40 US clinical centers, breast cancer hazard ratio estimates for this CEE regimen were compared between the Women’s Health Initiative clinical trial and observational study toward understanding this apparent discrepancy and refining hazard ratio estimates. After control for prior use of postmenopausal hormone therapy and for confounding factors, CEE hazard ratio estimates were higher from the observational study compared with the clinical trial by 43% (p = 0.12). However, after additional control for time from menopause to first use of postmenopausal hormone therapy, the hazard ratios agreed closely between the two cohorts (p = 0.82). For women who begin use soon after menopause, combined analyses of clinical trial and observational study data do not provide clear evidence of either an overall reduction or an increase in breast cancer risk with CEEs, although hazard ratios appeared to be relatively higher among women having certain breast cancer risk factors or a low body mass index. PMID:18448442

Wireless remote control clinical image workflow: utilizing a PDA for offsite distribution

NASA Astrophysics Data System (ADS)

Liu, Brent J.; Documet, Luis; Documet, Jorge; Huang, H. K.; Muldoon, Jean

2004-04-01

Last year we presented in RSNA an application to perform wireless remote control of PACS image distribution utilizing a handheld device such as a Personal Digital Assistant (PDA). This paper describes the clinical experiences including workflow scenarios of implementing the PDA application to route exams from the clinical PACS archive server to various locations for offsite distribution of clinical PACS exams. By utilizing this remote control application, radiologists can manage image workflow distribution with a single wireless handheld device without impacting their clinical workflow on diagnostic PACS workstations. A PDA application was designed and developed to perform DICOM Query and C-Move requests by a physician from a clinical PACS Archive to a CD-burning device for automatic burning of PACS data for the distribution to offsite. In addition, it was also used for convenient routing of historical PACS exams to the local web server, local workstations, and teleradiology systems. The application was evaluated by radiologists as well as other clinical staff who need to distribute PACS exams to offsite referring physician"s offices and offsite radiologists. An application for image workflow management utilizing wireless technology was implemented in a clinical environment and evaluated. A PDA application was successfully utilized to perform DICOM Query and C-Move requests from the clinical PACS archive to various offsite exam distribution devices. Clinical staff can utilize the PDA to manage image workflow and PACS exam distribution conveniently for offsite consultations by referring physicians and radiologists. This solution allows the radiologist to expand their effectiveness in health care delivery both within the radiology department as well as offisite by improving their clinical workflow.

Angiogenic factors combined with clinical risk factors to predict preterm pre-eclampsia in nulliparous women: a predictive test accuracy study.

PubMed

Myers, J E; Kenny, L C; McCowan, L M E; Chan, E H Y; Dekker, G A; Poston, L; Simpson, N A B; North, R A

2013-09-01

To assess the performance of clinical risk factors, uterine artery Doppler and angiogenic markers to predict preterm pre-eclampsia in nulliparous women. Predictive test accuracy study. Prospective multicentre cohort study Screening for Pregnancy Endpoints (SCOPE). Low-risk nulliparous women with a singleton pregnancy were recruited. Clinical risk factor data were obtained and plasma placental growth factor (PlGF), soluble endoglin and soluble fms-like tyrosine kinase-1 (sFlt-1) were measured at 14-16 weeks of gestation. Prediction models were developed using multivariable stepwise logistic regression. Preterm pre-eclampsia (delivered before 37(+0)  weeks of gestation). Of the 3529 women recruited, 187 (5.3%) developed pre-eclampsia of whom 47 (1.3%) delivered preterm. Controls (n = 188) were randomly selected from women without preterm pre-eclampsia and included women who developed other pregnancy complications. An area under a receiver operating characteristic curve (AUC) of 0.76 (95% CI 0.67-0.84) was observed using previously reported clinical risk variables. The AUC improved following the addition of PlGF measured at 14-16 weeks (0.84; 95% CI 0.77-0.91), but no further improvement was observed with the addition of uterine artery Doppler or the other angiogenic markers. A sensitivity of 45% (95% CI 0.31-0.59) (5% false-positive rate) and post-test probability of 11% (95% CI 9-13) were observed using clinical risk variables and PlGF measurement. Addition of plasma PlGF at 14-16 weeks of gestation to clinical risk assessment improved the identification of nulliparous women at increased risk of developing preterm pre-eclampsia, but the performance is not sufficient to warrant introduction as a clinical screening test. These findings are marker dependent, not assay dependent; additional markers are needed to achieve clinical utility. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

Systematic Review and Meta-Analysis of the Clinical Efficacy and Adverse Effects of Chinese Herbal Decoction for the Treatment of Gout

PubMed Central

Liu, Xiaoyu; Chen, Pinyi; Liu, Ling; Zhang, Yanqi; Wu, Yazhou; Pettigrew, Julia Christine; Cheng, Dixiang; Yi, Dong

2014-01-01

Background In East Asia, numerous reports describe the utilization of traditional Chinese herbal decoctions to treat gout. However, the reported clinical effects vary. Objectives In this study, we reviewed and analyzed a large number of randomized controlled clinical trials to systematically assess the clinical efficacy and adverse reactions of Chinese herbal decoctions for treating gout. Methods We performed a comprehensive search of databases, such as PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese biomedical literature database, et al. In addition, we manually searched the relevant meeting information in the library of the Third Military Medical University. Results Finally, 17 randomized controlled trials with a sample size of 1,402 cases met the criteria and were included in the study. The results of the meta-analysis showed that when gout had progressed to the stage of acute arthritis, there was no significant difference in clinical efficacy between Chinese herbal decoctions and traditional Western medicine, as indicated based on the following parameters: serum uric acid (standardized mean difference (SMD):0.35, 95% confidence interval (CI): 0.03 to 0.67), C reactive protein (SMD: 0.25, 95% CI: −0.18 to 0.69), erythrocyte sedimentation rate (SMD: 0.21, 95% CI: −0.02 to 0.45) and overall clinical response (relative risk (RR): 1.05, 95% CI: 1.01 to 1.10). However, the Chinese herbal decoction was significantly better than traditional Western medicine in controlling adverse drug reactions (RR: 0.06, 95% CI: 0.03 to 0.13). Conclusions Through a systematic review of the clinical efficacy and safety of Chinese herbal decoctions and traditional Western medicine for the treatment of gout, we found that Chinese herbal decoction and traditional Western medicine led to similar clinical efficacy, but the Chinese herbal decoctions were superior to Western medicine in terms of controlling adverse drug reactions. PMID:24465466

Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma?

PubMed

Koenig, Steven M; Murray, John J; Wolfe, James; Andersen, Leslie; Yancey, Steve; Prillaman, Barbara; Stauffer, John; Dorinsky, Paul

2008-05-01

Little is known about the use of biomarkers in guiding treatment decisions in routine asthma management. The objective of this study was to determine whether adding a LABA to an ICS would control bronchial hyperresponsiveness (BHR) at an overall lower dose of ICS when titration of medication was based upon the assessment of routine clinical measures with or without the measurement of BHR. After a 2-week run-in period, subjects (> or = 12 years) were randomized to one of three treatment groups. Two groups followed a BHR treatment strategy (based on clinical parameters [lung function, asthma symptoms, and bronchodilator use] and BHR) and were treated with either fluticasone propionate/salmeterol (FSC(BHR) group) or fluticasone propionate (FP(BHR) group) (n=156 each). The third group followed a clinical treatment algorithm (based on clinical parameters alone) and were treated with fluticasone propionate (FP(REF) group; n=154). All treatments were administered via Diskus. Treatment doses were adjusted as needed every 8 weeks for 40 weeks according to the subject's derived severity class, which was based on clinical measures of asthma control with or without BHR. The mean total daily inhaled corticosteroids (ICS) dose during the double-blind treatment period was lower, although not statistically significant, in the FSC(BHR) group compared with the FP(BHR) group (a difference of -42.9 mcg; p=0.07). Compared with the FP(REF) group, the mean total daily ICS dose was higher in the FSC(BHR) group (a difference of 85.2 mcg) and was significantly higher in the FP(BHR) group (a difference of 131.2 mcg, p=0.037). This study demonstrated that for most subjects, control of BHR was maintained when treatment was directed toward control of clinical parameters. In addition, there was a trend towards control of BHR and clinical measures at a lower dose of ICS when used concurrently with salmeterol.

Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

PubMed

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

[The Contribution of GMP-grade Hospital Preparation to Translational Research].

PubMed

Yonezawa, Atsushi; Kajiwara, Moto; Minami, Ikuko; Omura, Tomohiro; Nakagawa, Shunsaku; Matsubara, Kazuo

2015-01-01

Translational research is important for applying the outcomes of basic research studies to practical medical treatments. In exploratory early-phase clinical trials for an innovative therapy, researchers should generally manufacture investigational agents by themselves. To provide investigational agents with safety and high quality in clinical studies, appropriate production management and quality control are essential. In the Department of Pharmacy of Kyoto University Hospital, a manufacturing facility for sterile drugs was established, independent of existing manufacturing facilities. Manuals on production management and quality control were developed according to Good Manufacturing Practices (GMP) for Investigational New Drugs (INDs). Advanced clinical research has been carried out using investigational agents manufactured in our facility. These achievements contribute to both the safety of patients and the reliability of clinical studies. In addition, we are able to do licensing-out of our technique for the manufacture of investigational drugs. In this symposium, we will introduce our GMP grade manufacturing facility for sterile drugs and discuss the role of GMP grade hospital preparation in translational research.

Measuring Workload Demand of Informatics Systems with the Clinical Case Demand Index

PubMed Central

Iyengar, M. Sriram; Rogith, Deevakar; Florez-Arango, Jose F

2017-01-01

Introduction: The increasing use of Health Information Technology (HIT) can add substantially to workload on clinical providers. Current methods for assessing workload do not take into account the nature of clinical cases and the use of HIT tools while solving them. Methods: The Clinical Case Demand Index (CCDI), consisting of a summary score and visual representation, was developed to meet this need. Consistency with current perceived workload measures was evaluated in a Randomized Control Trial of a mobile health system. Results: CCDI is significantly correlated with existing workload measures and inversely related to provider performance. Discussion: CCDI combines subjective and objective characteristics of clinical cases along with cognitive and clinical dimensions. Applications include evaluation of HIT tools, clinician scheduling, medical education. Conclusion: CCDI supports comparative effectiveness research of HIT tools. In addition, CCDI could have numerous applications including training, clinical trials, design of clinical workflows, and others. PMID:29854166

Error mapping controller: a closed loop neuroprosthesis controlled by artificial neural networks.

PubMed

Pedrocchi, Alessandra; Ferrante, Simona; De Momi, Elena; Ferrigno, Giancarlo

2006-10-09

The design of an optimal neuroprostheses controller and its clinical use presents several challenges. First, the physiological system is characterized by highly inter-subjects varying properties and also by non stationary behaviour with time, due to conditioning level and fatigue. Secondly, the easiness to use in routine clinical practice requires experienced operators. Therefore, feedback controllers, avoiding long setting procedures, are required. The error mapping controller (EMC) here proposed uses artificial neural networks (ANNs) both for the design of an inverse model and of a feedback controller. A neuromuscular model is used to validate the performance of the controllers in simulations. The EMC performance is compared to a Proportional Integral Derivative (PID) included in an anti wind-up scheme (called PIDAW) and to a controller with an ANN as inverse model and a PID in the feedback loop (NEUROPID). In addition tests on the EMC robustness in response to variations of the Plant parameters and to mechanical disturbances are carried out. The EMC shows improvements with respect to the other controllers in tracking accuracy, capability to prolong exercise managing fatigue, robustness to parameter variations and resistance to mechanical disturbances. Different from the other controllers, the EMC is capable of balancing between tracking accuracy and mapping of fatigue during the exercise. In this way, it avoids overstressing muscles and allows a considerable prolongation of the movement. The collection of the training sets does not require any particular experimental setting and can be introduced in routine clinical practice.

Error mapping controller: a closed loop neuroprosthesis controlled by artificial neural networks

PubMed Central

Pedrocchi, Alessandra; Ferrante, Simona; De Momi, Elena; Ferrigno, Giancarlo

2006-01-01

Background The design of an optimal neuroprostheses controller and its clinical use presents several challenges. First, the physiological system is characterized by highly inter-subjects varying properties and also by non stationary behaviour with time, due to conditioning level and fatigue. Secondly, the easiness to use in routine clinical practice requires experienced operators. Therefore, feedback controllers, avoiding long setting procedures, are required. Methods The error mapping controller (EMC) here proposed uses artificial neural networks (ANNs) both for the design of an inverse model and of a feedback controller. A neuromuscular model is used to validate the performance of the controllers in simulations. The EMC performance is compared to a Proportional Integral Derivative (PID) included in an anti wind-up scheme (called PIDAW) and to a controller with an ANN as inverse model and a PID in the feedback loop (NEUROPID). In addition tests on the EMC robustness in response to variations of the Plant parameters and to mechanical disturbances are carried out. Results The EMC shows improvements with respect to the other controllers in tracking accuracy, capability to prolong exercise managing fatigue, robustness to parameter variations and resistance to mechanical disturbances. Conclusion Different from the other controllers, the EMC is capable of balancing between tracking accuracy and mapping of fatigue during the exercise. In this way, it avoids overstressing muscles and allows a considerable prolongation of the movement. The collection of the training sets does not require any particular experimental setting and can be introduced in routine clinical practice. PMID:17029636

Smoking cessation in primary care clinics.

PubMed

Sippel, J M; Osborne, M L; Bjornson, W; Goldberg, B; Buist, A S

1999-11-01

To document smoking cessation rates achieved by applying the 1996 Agency for Health Care Policy and Research (AHCPR) smoking cessation guidelines for primary care clinics, compare these quit rates with historical results, and determine if quit rates improve with an additional motivational intervention that includes education as well as spirometry and carbon monoxide measurements. Randomized clinical trial. Two university-affiliated community primary care clinics. Two hundred five smokers with routinely scheduled appointments. All smokers were given advice and support according to AHCPR guidelines. Half of the subjects received additional education with spirometry and carbon monoxide measurements. Quit rate was evaluated at 9-month follow-up. Eleven percent of smokers were sustained quitters at follow-up. Sustained quit rate was no different for intervention and control groups (9% vs 14%; [OR] 0.6; 95% [CI] 0.2, 1.4). Nicotine replacement therapy was strongly associated with sustained cessation (OR 6.7; 95% CI 2.3, 19.6). Subjects without insurance were the least likely to use nicotine replacement therapy ( p =.05). Historical data from previously published studies showed that 2% of smokers quit following physician advice, and additional support similar to AHCPR guidelines increased the quit rate to 5%. The sustained smoking cessation rate achieved by following AHCPR guidelines was 11% at 9 months, which compares favorably with historical results. Additional education with spirometry did not improve the quit rate. Nicotine replacement therapy was the strongest predictor of cessation, yet was used infrequently owing to cost. These findings support the use of AHCPR guidelines in primary care clinics, but do not support routine spirometry for motivating patients similar to those studied here.

Nutritional status in patients with cutaneous leishmaniasis and a study of the effects of zinc supplementation together with antimony treatment.

PubMed

Guzman-Rivero, Miguel; Rojas, Ernesto; Verduguez-Orellana, Aleida; Pardo, Henry; Torrico, Mary Cruz; Cloetens, Lieselotte; Akesson, Björn; Sejas, Edgar

2014-01-01

The role of micronutrient status for the incidence and clinical course of cutaneous leishmaniasis is not much studied. Still zinc supplementation in leishmaniasis has shown some effect on the clinical recovery, but the evidence in humans is limited. To compare biochemical nutritional status in cutaneous leishmaniasis patients with that in controls and to study the effects of zinc supplementation for 60 days. Twenty-nine patients with cutaneous leishmaniasis were treated with antimony for 20 days. Fourteen of them got 45 mg zinc daily and 15 of them got placebo. Biomarkers of nutritional and inflammatory status and changes in size and characteristics of skin lesions were measured. The level of transferrin receptor was higher in patients than in controls but otherwise no differences in nutritional status were found between patients and controls. No significant effects of zinc supplementation on the clinical recovery were observed as assessed by lesion area reduction and characteristics or on biochemical parameters. It is concluded that nutritional status was essentially unaffected in cutaneous leishmaniasis and that oral zinc supplementation administered together with intramuscular injection of antimony had no additional clinical benefit.

PubMed Central

Jannin, J.; Moulia-Pelat, J. P.; Chanfreau, B.; Penchenier, L.; Louis, J. P.; Nzaba, P.; de La Baume, F. E.; Eozenou, P.; Cattand, P.

1993-01-01

A case-control study was carried out in the Congo to define a scoring system based on a number of clinical and epidemiological criteria of African trypanosomiasis due to Trypanosoma brucei gambiense which could be used by peripheral health services to establish a diagnosis. The survey comprised 163 cases and 326 controls. Clinical signs and symptoms were fever, headache, pruritus and skin lesions due to scratching, diarrhoea, oedema, cervical adenopathies, sleep rhythm disturbances, changes in appetite, amenorrhoea or impotence, mental confusion, neurological signs, and other minor clinical disturbances. Other criteria were a history of previous trypanosomiasis and the presence of domestic animals in the home environment. Analysis of the results showed that neither a single criterion nor a group of criteria is pathognomonic for the disease. The selected criteria do not allow discrimination of sleeping sickness patients among suspected individuals who present themselves. A scoring system is therefore of little use at the peripheral level of health services, particularly when considering the additional workload involved. The low diagnostic value of these clinical signs and symptoms and other indicators in African trypanosomiasis stresses the difficulty in developing an early warning tool for an integrated control strategy in primary health care. PMID:8490985

Using suggestion to model different types of automatic writing.

PubMed

Walsh, E; Mehta, M A; Oakley, D A; Guilmette, D N; Gabay, A; Halligan, P W; Deeley, Q

2014-05-01

Our sense of self includes awareness of our thoughts and movements, and our control over them. This feeling can be altered or lost in neuropsychiatric disorders as well as in phenomena such as "automatic writing" whereby writing is attributed to an external source. Here, we employed suggestion in highly hypnotically suggestible participants to model various experiences of automatic writing during a sentence completion task. Results showed that the induction of hypnosis, without additional suggestion, was associated with a small but significant reduction of control, ownership, and awareness for writing. Targeted suggestions produced a double dissociation between thought and movement components of writing, for both feelings of control and ownership, and additionally, reduced awareness of writing. Overall, suggestion produced selective alterations in the control, ownership, and awareness of thought and motor components of writing, thus enabling key aspects of automatic writing, observed across different clinical and cultural settings, to be modelled. Copyright © 2014. Published by Elsevier Inc.

Using clinical indicators to facilitate quality improvement via the accreditation process: an adaptive study into the control relationship.

PubMed

Chuang, Sheuwen; Howley, Peter P; Hancock, Stephen

2013-07-01

The aim of the study was to determine accreditation surveyors' and hospitals' use and perceived usefulness of clinical indicator reports and the potential to establish the control relationship between the accreditation and reporting systems. The control relationship refers to instructional directives, arising from appropriately designed methods and efforts towards using clinical indicators, which provide a directed moderating, balancing and best outcome for the connected systems. Web-based questionnaire survey. Australian Council on Healthcare Standards' (ACHS) accreditation and clinical indicator programmes. Seventy-three of 306 surveyors responded. Half used the reports always/most of the time. Five key messages were revealed: (i) report use was related to availability before on-site investigation; (ii) report use was associated with the use of non-ACHS reports; (iii) a clinical indicator set's perceived usefulness was associated with its reporting volume across hospitals; (iv) simpler measures and visual summaries in reports were rated the most useful; (v) reports were deemed to be suitable for the quality and safety objectives of the key groups of interested parties (hospitals' senior executive and management officers, clinicians, quality managers and surveyors). Implementing the control relationship between the reporting and accreditation systems is a promising expectation. Redesigning processes to ensure reports are available in pre-survey packages and refined education of surveyors and hospitals on how to better utilize the reports will support the relationship. Additional studies on the systems' theory-based model of the accreditation and reporting system are warranted to establish the control relationship, building integrated system-wide relationships with sustainable and improved outcomes.

A Randomized Trial Testing the Impact of Narrative Vignettes vs. Guideline Summaries on Provider Response to a Professional Organization Clinical Policy for Safe Opioid Prescribing

PubMed Central

Meisel, Zachary F.; Metlay, Joshua P.; Sinnenberg, Lauren; Kilaru, Austin S.; Grossestreuer, Anne; Barg, Frances K.; Shofer, Frances S.; Rhodes, Karin V.; Perrone, Jeanmarie

2016-01-01

Background Clinical guidelines are known to be underused by practitioners. In response to the challenges of treating pain amidst a prescription opioid epidemic, the American College of Emergency Physicians published an evidence-based clinical policy for opioid prescribing in 2012. Evidence-based narratives, an effective method of communicating health information in a variety of settings, offer a novel strategy for disseminating guidelines to physicians and engaging providers with clinical evidence. Objectives To compare whether narrative vignettes embedded in the American College of Emergency Physician (ACEP) daily e-newsletter improved dissemination of the clinical policy to ACEP members, and engagement of members with the clinical policy, compared to traditional summary text. Methods A prospective randomized controlled study, entitled Stories to Promote Information using Narrative (SPIN) trial, was performed. Derived from qualitative interviews with 61 ACEP physicians, 4 narrative vignettes were selected and refined, using a consensus panel of clinical and implementation experts. All ACEP members were then block randomized by state of residence to receive alternative versions of a daily emailed newsletter for a total of 24 days during a 9 week period. Narrative newsletters contained a selection of vignettes that referenced opioid prescription dilemmas. Control newsletters contained a selection of descriptive text about the clinical policy using similar length and appearance to the narrative vignettes. Embedded in the newsletters were web links to the complete vignette or traditional summary text, as well as additional links to the full ACEP clinical policy and a website providing assistance with prescription drug monitoring program enrollment. The newsletters were otherwise identical. Outcomes measured were the percentage of subjects who visited any of the web pages that contained additional guideline related information and the odds of any unique physician visiting these web pages during the study. Results 27,592 physicians were randomized and 21,226 received the newsletter during the study period. When counting each physician once over the study period, there were 509 unique visitors in the narrative group and 173 unique visitors in the control group (4.8% vs. 1.6%, difference 3.2% 95%CI 2.7%-3.7%). There were 744 gross visits from the e-newsletter to any of the three web pages in the narrative group compared to 248 in the control group (7.0% vs. 2.3%, OR 3.2 (95% CI 2.7-3.6). Over the course of the study, the odds ratio of any physician in the narrative group visiting one of the three informational web sites compared to the control group was 3.1 (95% CI 2.6-3.6). Conclusion Among a national sample of emergency physicians, narrative vignettes outperformed traditional guideline text in promoting engagement with an evidence-based clinical guideline related to opioid prescriptions. PMID:27133392

[Prospective economic evaluation of image-guided radiation therapy for prostate cancer in the framework of the national programme for innovative and costly therapies assessment].

PubMed

Pommier, P; Morelle, M; Perrier, L; de Crevoisier, R; Laplanche, A; Dudouet, P; Mahé, M-A; Chauvet, B; Nguyen, T-D; Créhange, G; Zawadi, A; Chapet, O; Latorzeff, I; Bossi, A; Beckendorf, V; Touboul, E; Muracciole, X; Bachaud, J-M; Supiot, S; Lagrange, J-L

2012-09-01

The main objective of the economical study was to prospectively and randomly assess the additional costs of daily versus weekly patient positioning quality control in image-guided radiotherapy (IGRT), taking into account the modalities of the 3D-imaging: tomography (CBCT) or gold seeds implants. A secondary objective was to prospectively assess the additional costs of 3D versus 2D imaging with portal imaging for patient positioning controls. Economics data are issued from a multicenter randomized medico-economics trial comparing the two frequencies of patient positioning control during prostate IGRT. A prospective cohort with patient positioning control with PI (control group) was constituted for the cost comparison between 3D (IGRT) versus 2D imaging. The economical evaluation was focused to the radiotherapy direct costs, adopting the hospital's point of view and using a microcosting method applied to the parameters that may lead to cost differences between evaluated strategies. The economical analysis included a total of 241 patients enrolled between 2007 and 2011 in seven centres, 183 in the randomized study (128 with CBCT and 55 with fiducial markers) and 58 in the control group. Compared to weekly controls, the average additional cost per patient of daily controls was €847 (CBCT) and €179 (markers). Compared to PI, the average additional cost per patient was €1392 (CBCT) and €997 (fiducial markers) for daily controls; €545 (CBCT) and €818 (markers) in case of weekly controls. A daily frequency for image control in IGRT and 3D images patient positioning control (IGRT) for prostate cancer lead to significant additional cost compared to weekly control and 2D imaging (PI). Long-term clinical assessment will permit to assess the medico-economical ratio of these innovative radiotherapy modalities. Copyright © 2012 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

Resistant starch does not affect zinc homeostasis in rural Malawian children

USDA-ARS?s Scientific Manuscript database

This study tested the hypothesis that Malawian children at risk for zinc deficiency will have reduced endogenous fecal zinc (EFZ) and increased net absorbed zinc (NAZ) following the addition of high amylose maize resistant starch (RS) to their diet. This was a small controlled clinical trial to dete...

An Automated Treatment Plan Quality Control Tool for Intensity-Modulated Radiation Therapy Using a Voxel-Weighting Factor-Based Re-Optimization Algorithm

PubMed Central

Song, Ting; Li, Nan; Zarepisheh, Masoud; Li, Yongbao; Gautier, Quentin; Zhou, Linghong; Mell, Loren; Jiang, Steve; Cerviño, Laura

2016-01-01

Intensity-modulated radiation therapy (IMRT) currently plays an important role in radiotherapy, but its treatment plan quality can vary significantly among institutions and planners. Treatment plan quality control (QC) is a necessary component for individual clinics to ensure that patients receive treatments with high therapeutic gain ratios. The voxel-weighting factor-based plan re-optimization mechanism has been proved able to explore a larger Pareto surface (solution domain) and therefore increase the possibility of finding an optimal treatment plan. In this study, we incorporated additional modules into an in-house developed voxel weighting factor-based re-optimization algorithm, which was enhanced as a highly automated and accurate IMRT plan QC tool (TPS-QC tool). After importing an under-assessment plan, the TPS-QC tool was able to generate a QC report within 2 minutes. This QC report contains the plan quality determination as well as information supporting the determination. Finally, the IMRT plan quality can be controlled by approving quality-passed plans and replacing quality-failed plans using the TPS-QC tool. The feasibility and accuracy of the proposed TPS-QC tool were evaluated using 25 clinically approved cervical cancer patient IMRT plans and 5 manually created poor-quality IMRT plans. The results showed high consistency between the QC report quality determinations and the actual plan quality. In the 25 clinically approved cases that the TPS-QC tool identified as passed, a greater difference could be observed for dosimetric endpoints for organs at risk (OAR) than for planning target volume (PTV), implying that better dose sparing could be achieved in OAR than in PTV. In addition, the dose-volume histogram (DVH) curves of the TPS-QC tool re-optimized plans satisfied the dosimetric criteria more frequently than did the under-assessment plans. In addition, the criteria for unsatisfied dosimetric endpoints in the 5 poor-quality plans could typically be satisfied when the TPS-QC tool generated re-optimized plans without sacrificing other dosimetric endpoints. In addition to its feasibility and accuracy, the proposed TPS-QC tool is also user-friendly and easy to operate, both of which are necessary characteristics for clinical use. PMID:26930204

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

PubMed

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

2016-05-01

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

Long-term safety, efficacy, and tolerability of imidafenacin in the treatment of overactive bladder: a review of the Japanese literature

PubMed Central

Masumori, Naoya

2013-01-01

Imidafenacin is an antimuscarinic agent with high affinity for the M3 and M1 muscarinic receptor subtypes and low affinity for the M2 subtype, and is used to treat overactive bladder. Several animal studies have demonstrated that imidafenacin has organ selectivity for the bladder over the salivary glands, colon, heart, and brain. In Phase I studies in humans, the approximately 2.9-hour elimination half-life of imidafenacin was shorter than that of other antimuscarinics such as tolterodine and solifenacin. Imidafenacin was approved for clinical use in overactive bladder in Japan in 2007 after a randomized, double-blind, placebo-controlled Phase II study and a propiverine-controlled Phase III study conducted in Japanese patients demonstrated that imidafenacin 0.1 mg twice daily was clinically effective for treating overactive bladder and was not inferior to propiverine for reduction of episodes of incontinence, with a better safety profile than propiverine. Several short-term clinical studies have demonstrated that imidafenacin also improves sleep disorders, nocturia, and nocturia-related quality of life. In addition, it is speculated that addon therapy with imidafenacin is beneficial for men with benign prostatic hyperplasia whose overactive bladder symptoms are not controlled by alpha-1 adrenoceptor antagonists. No cognitive impairment or influence of imidafenacin on the QTc interval has been observed. Although there have been very few relevant long-term clinical studies, the available information suggests the long-term efficacy, safety, and tolerability of imidafenacin, with less frequent severe adverse events, such as dry mouth and constipation. In addition, imidafenacin can be used safely for a long time even for cognitively vulnerable elderly patients with symptoms of overactive bladder. Thus, it is highly likely that imidafenacin is safe, efficacious, and tolerable to control symptoms of overactive bladder even over the long term. However, it remains unknown if the practical effectiveness of imidafenacin is applicable to ethnic groups other than Japanese. PMID:23390360

Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial.

PubMed

Lai, Michelle Mei Yee; Roberts, Noel; Martin, Jenepher

2014-09-17

Oral feedback from clinical educators is the traditional teaching method for improving clinical consultation skills in medical students. New approaches are needed to enhance this teaching model. Multisource feedback is a commonly used assessment method for learning among practising clinicians, but this assessment has not been explored rigorously in medical student education. This study seeks to evaluate if additional feedback on patient satisfaction improves medical student performance. The Patient Teaching Associate (PTA) Feedback Study is a single site randomized controlled, double-blinded trial with two parallel groups.An after-hours general practitioner clinic in Victoria, Australia, is adapted as a teaching clinic during the day. Medical students from two universities in their first clinical year participate in six simulated clinical consultations with ambulatory patient volunteers living with chronic illness. Eligible students will be randomized in equal proportions to receive patient satisfaction score feedback with the usual multisource feedback and the usual multisource feedback alone as control. Block randomization will be performed. We will assess patient satisfaction and consultation performance outcomes at baseline and after one semester and will compare any change in mean scores at the last session from that at baseline. We will model data using regression analysis to determine any differences between intervention and control groups. Full ethical approval has been obtained for the study. This trial will comply with CONSORT guidelines and we will disseminate data at conferences and in peer-reviewed journals. This is the first proposed trial to determine whether consumer feedback enhances the use of multisource feedback in medical student education, and to assess the value of multisource feedback in teaching and learning about the management of ambulatory patients living with chronic conditions. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613001055796.

Antibiotic therapy as an adjunct to scaling and root planing in smokers: a systematic review and meta-analysis.

PubMed

Assem, Naida Zanini; Alves, Márcio Luiz Ferro; Lopes, Alessandra Barreto; Gualberto, Erivan Clementino; Garcia, Valdir Gouveia; Theodoro, Letícia Helena

2017-07-03

The aim of this study was to perform a systematic review and meta-analysis to examine the effect of systemic antibiotics in the periodontal treatment of smokers. The selection criteria were as follows: controlled randomized clinical trials; studies published in English; studies with smoker patients diagnosed with chronic periodontitis; patients without systemic diseases; studies that used systemic antibiotic therapy associated with periodontal treatment; studies that presented results for the test and control groups and assessments of clinical periodontal parameters, such as probing depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). The differences in average weights were calculated with a confidence interval (CI) of 95% for PD reduction, CAL gain and BOP. The means of the periodontal clinical parameters were compared between the baseline and post-treatment periods between the test groups and the control groups. The heterogeneity was assessed using the Cochran Q test (Q (df = 3), α = 5%). A total of 67 articles were found, and after the selection process, three randomized controlled trials were included in the meta-analysis. The results indicate that SRP associated with systemic antibiotics promoted additional benefits when compared to SRP alone, with a greater reduction of PD (p = 0.0359, CI = -0.42, -0.01) and a gain of CAL (p = 0.0161, CI = -0.39, -0.04). There was a modest PD reduction (PD, DM -0.21) and a modest CAL gain (CAL, DM -0.22). The results of our meta-analysis reveal the clinical benefits of systemic antibiotics as an adjunct to the non-surgical periodontal treatment of smokers. These clinical improvements, although statistically significant, appeared to be of little clinical relevance.

Usefulness of a topical combination of dinotefuran and pyriproxyfen for long-term control of clinical signs of allergic dermatitis in privately-owned cats in Ile-de-France region.

PubMed

Crosaz, Odile; Bonati, Silvia; Briand, Amaury; Chapelle, Elodie; Cochet-Faivre, Noëlle; Ka, Diane; Darmon-Hadjaje, Céline; Varloud, Marie; Guillot, Jacques

2017-08-23

The present study assessed the activity of a combination of dinotefuran and pyriproxyfen (Vectra® Felis) for long-term control (3 months) of allergic dermatitis (AD) in privately-owned cats under common household conditions in Ile-de-France region. This was an open pre-treatment vs post-treatment study. Twenty-eight client-owned cats with clinical signs of AD were enrolled in the study. They received topical application of the combination of dinotefuran and pyriproxyfen on days 0, 28, 56 and 84. Two parameters (clinical signs and pruritus severity) were used to assess the animals' condition on days 0, 28 and 84. Fleas were counted if they were observed. Of the 28 cats initially enrolled, 26 were presented on day 28 and 20 for the final evaluation on day 84. A significant improvement in clinical signs and pruritus was observed in cats for which fleas and/or flea feces were detected on day 0. Globally, the post-treatment AD clinical scores on days 28 and 84 were different from that of the pre-treatment on day 0, with a reduction of 30% and 71%, respectively. For cats with fleas and/or flea feces, the reduction on days 28 and 84 was 33% and 85%, respectively. The improvement of clinical signs and pruritus was not significant in cats with no visible fleas and no flea feces at the beginning of the trial (n = 8). The present study indicated that the treatment with a combination of dinotefuran and pyriproxyfen should be considered as useful in controlling fleas on cats without additional environmental treatment and useful for long-term control of clinical signs and pruritus in allergic cats.

Physician styles of decision-making for a complex condition: Type 2 diabetes with co-morbid mental illness.

PubMed

Trachtenberg, Felicia L; Pober, David M; Welch, Lisa C; McKinlay, John B

Variation in physician decisions may reflect personal styles of decision-making, as opposed to singular clinical actions and these styles may be applied differently depending on patient complexity. The objective of this study is to examine clusters of physician decision-making for type 2 diabetes, overall and in the presence of a mental health co-morbidity. This randomized balanced factorial experiment presented video vignettes of a "patient" with diagnosed, but uncontrolled type 2 diabetes. "Patients" were systematically varied by age, sex, race and co-morbidity (depression, schizophrenia with normal or bizarre affect, eczema as control). Two hundred and fifty-six primary care physicians, balanced by gender and experience level, completed a structured interview about clinical management. Cluster analysis identified 3 styles of diabetes management. "Minimalists" (n=84) performed fewer exams or tests compared to "middle of the road" physicians (n=84). "Interventionists" (n=88) suggested more medications and referrals. A second cluster analysis, without control for co-morbidities, identified an additional cluster of "information seekers" (n=15) who requested more additional information and referrals. Physicians ranking schizophrenia higher than diabetes on their problem list were more likely "minimalists" and none were "interventionists" or "information seekers". Variations in clinical management encompass multiple clinical actions and physicians subtly shift these decision-making styles depending on patient co-morbidities. Physicians' practice styles may help explain persistent differences in patient care. Training and continuing education efforts to encourage physicians to implement evidence-based clinical practice should account for general styles of decision-making and for how physicians process complicating comorbidities.

Implications of clinical trial design on sample size requirements.

PubMed

Leon, Andrew C

2008-07-01

The primary goal in designing a randomized controlled clinical trial (RCT) is to minimize bias in the estimate of treatment effect. Randomized group assignment, double-blinded assessments, and control or comparison groups reduce the risk of bias. The design must also provide sufficient statistical power to detect a clinically meaningful treatment effect and maintain a nominal level of type I error. An attempt to integrate neurocognitive science into an RCT poses additional challenges. Two particularly relevant aspects of such a design often receive insufficient attention in an RCT. Multiple outcomes inflate type I error, and an unreliable assessment process introduces bias and reduces statistical power. Here we describe how both unreliability and multiple outcomes can increase the study costs and duration and reduce the feasibility of the study. The objective of this article is to consider strategies that overcome the problems of unreliability and multiplicity.

Applying the theory of planned behavior: nursing students' intention to seek clinical experiences using the essential clinical behavior database.

PubMed

Meyer, Linda

2002-03-01

This study examined the antecedents and determinants predictive of whether nursing students (N = 92) intend to ask for assignments to perform nursing behaviors after using a database to record essential clinical behaviors. The results of applying the theory of planned behavior (TPB) to behavioral intention using multivariant path analysis suggested that the endogenous variables, attitude and subjective norms, had a significant effect on the intention to ask for assignments to perform nursing behaviors. In addition, it was primarily through attitudes and subjective norms that the respective antecedents or exogenous variables, behavioral beliefs and normative beliefs, affected the intention to ask for assignments to perform nursing behaviors. The lack of direct influence of perceived behavioral control on intention and the direct negative impact of control belief on intention were contrary to expectations, given the tenets of the TPB.

Electronic Immunization Alerts and Spillover Effects on Other Preventive Care.

PubMed

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

2017-08-01

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

Perspectives on hand function in girls and women with Rett syndrome.

PubMed

Downs, Jenny; Parkinson, Stephanie; Ranelli, Sonia; Leonard, Helen; Diener, Pamela; Lotan, Meir

2014-06-01

Rett syndrome is a rare neurodevelopmental disorder that is usually associated with a mutation on the X-linked MECP2 gene. Hand function is particularly affected and we discuss theoretical and practical perspectives for optimising hand function in Rett syndrome. We reviewed the literature pertaining to hand function and stereotypies in Rett syndrome and developed a toolkit for their assessment and treatment. There is little published information on management of hand function in Rett syndrome. We suggest assessment and treatment strategies based on available literature, clinical experience and grounded in theories of motor control and motor learning. Additional studies are needed to determine the best treatments for hand function in Rett syndrome. Meanwhile, clinical needs can be addressed by supplementing the evidence base with an understanding of the complexities of Rett syndrome, clinical experience, environmental enrichment animal studies and theories of motor control and motor learning.

Clinical Application of Mesenchymal Stem Cells and Novel Supportive Therapies for Oral Bone Regeneration

PubMed Central

O'Valle, Francisco; Lanis, Alejandro; Dohan Ehrenfest, David M.; Wang, Hom-Lay; Galindo-Moreno, Pablo

2015-01-01

Bone regeneration is often needed prior to dental implant treatment due to the lack of adequate quantity and quality of the bone after infectious diseases, trauma, tumor, or congenital conditions. In these situations, cell transplantation technologies may help to overcome the limitations of autografts, xenografts, allografts, and alloplastic materials. A database search was conducted to include human clinical trials (randomized or controlled) and case reports/series describing the clinical use of mesenchymal stem cells (MSCs) in the oral cavity for bone regeneration only specifically excluding periodontal regeneration. Additionally, novel advances in related technologies are also described. 190 records were identified. 51 articles were selected for full-text assessment, and only 28 met the inclusion criteria: 9 case series, 10 case reports, and 9 randomized controlled clinical trials. Collectively, they evaluate the use of MSCs in a total of 290 patients in 342 interventions. The current published literature is very diverse in methodology and measurement of outcomes. Moreover, the clinical significance is limited. Therefore, the use of these techniques should be further studied in more challenging clinical scenarios with well-designed and standardized RCTs, potentially in combination with new scaffolding techniques and bioactive molecules to improve the final outcomes. PMID:26064899

Volumetric upper airway changes after rapid maxillary expansion: a systematic review and meta-analysis.

PubMed

Buck, Lloyd M; Dalci, Oyku; Darendeliler, M Ali; Papageorgiou, Spyridon N; Papadopoulou, Alexandra K

2017-10-01

Although Rapid Maxillary Expansion (RME) has been used for over a century, its effect on upper airways has not yet adequately been assessed in an evidence-based manner. To investigate the volumetric changes in the upper airway spaces following RME in growing subjects by means of acoustic rhinometry, three-dimensional radiography and digital photogrammetry. Literature search of electronic databases and additional manual searches up to February 2016. Randomized clinical trials, prospective or retrospective controlled clinical trials and cohort clinical studies of at least eight patients, where the RME appliance was left in place for retention, and a maximum follow-up of 8 months post-expansion. After duplicate data extraction and assessment of the risk of bias, the mean differences and 95 per cent confidence intervals (CIs) of upper airway volume changes were calculated with random-effects meta-analyses, followed by subgroup analyses, meta-regressions, and sensitivity analyses. Twenty studies were eligible for qualitative synthesis, of which 17 (3 controlled clinical studies and 14 cohort studies) were used in quantitative analysis. As far as total airway volume is concerned patients treated with RME showed a significant increase post-expansion (5 studies; increase from baseline: 1218.3mm3; 95 per cent CI: 702.0 to 1734.6mm3), which did not seem to considerably diminish after the retention period (11 studies; increase from baseline: 1143.9mm3; 95 per cent CI: 696.9 to 1590.9mm3). However, the overall quality of evidence was judged as very low, due to methodological limitations of the included studies, absence of untreated control groups, and inconsistency among studies. RME seems to be associated with an increase in the nasal cavity volume in the short and in the long term. However, additional well-conducted prospective controlled clinical studies are needed to confirm the present findings. None. Australian Society of Orthodontics Foundation for Research and Education Inc. © The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

Clinical, biomechanical and morphological assessment of anterior cruciate ligament Kevlar®-based artificial prosthesis in rabbit model.

PubMed

de la Garza-Castro, Santiago; González-Rivera, Carlos E; Vílchez-Cavazos, Félix; Morales-Avalos, Rodolfo; Barrera-Flores, Francisco J; Elizondo-Omaña, Rodrigo E; Soto-Dominguez, Adolfo; Acosta-Olivo, Carlos; Mendoza-Lemus, Oscar F

2017-07-27

The aim of this study was to evaluate the clinical, biomechanical and morphological characteristics of a Kevlar®-based prosthetic ligament as a synthetic graft of the anterior cruciate ligament (ACL) in an experimental animal model in rabbits. A total of 27 knees of rabbits randomly divided into 3 groups (control, ACL excision and ACL replacement with a Kevlar® prosthesis) were analyzed using clinical, biomechanical and morphological tests at 6, 12 and 18 weeks postprocedure. The mean displacement in mechanical testing was 0.73 ± 0.06 mm, 1.58 ± 0.19 mm and 0.94 ± 0.20 mm for the control, ACL excision and ACL replacement with synthetic prosthesis groups, respectively. The results showed an improvement in the stability of the knee with the use of the Kevlar® synthetic prosthesis in the biomechanical testing (p<0.05) compared with rabbits that underwent ACL excision, in addition to displacements that were larger but comparable to that in the control group (p>0.05), between the replacement group and the control group. The histological study revealed a good morphological adaptation of the synthetic material to the knee. This study proposes a new animal model for the placement and evaluation of Kevlar®-based synthetic ACL implants. The studied prosthesis showed promising behavior in the clinical and biomechanical tests and in the histological analysis. This study lays the foundation for further basic and clinical studies of artificial ACL prostheses using this material.

Protecting patient privacy when sharing patient-level data from clinical trials.

PubMed

Tucker, Katherine; Branson, Janice; Dilleen, Maria; Hollis, Sally; Loughlin, Paul; Nixon, Mark J; Williams, Zoë

2016-07-08

Greater transparency and, in particular, sharing of patient-level data for further scientific research is an increasingly important topic for the pharmaceutical industry and other organisations who sponsor and conduct clinical trials as well as generally in the interests of patients participating in studies. A concern remains, however, over how to appropriately prepare and share clinical trial data with third party researchers, whilst maintaining patient confidentiality. Clinical trial datasets contain very detailed information on each participant. Risk to patient privacy can be mitigated by data reduction techniques. However, retention of data utility is important in order to allow meaningful scientific research. In addition, for clinical trial data, an excessive application of such techniques may pose a public health risk if misleading results are produced. After considering existing guidance, this article makes recommendations with the aim of promoting an approach that balances data utility and privacy risk and is applicable across clinical trial data holders. Our key recommendations are as follows: 1. Data anonymisation/de-identification: Data holders are responsible for generating de-identified datasets which are intended to offer increased protection for patient privacy through masking or generalisation of direct and some indirect identifiers. 2. Controlled access to data, including use of a data sharing agreement: A legally binding data sharing agreement should be in place, including agreements not to download or further share data and not to attempt to seek to identify patients. Appropriate levels of security should be used for transferring data or providing access; one solution is use of a secure 'locked box' system which provides additional safeguards. This article provides recommendations on best practices to de-identify/anonymise clinical trial data for sharing with third-party researchers, as well as controlled access to data and data sharing agreements. The recommendations are applicable to all clinical trial data holders. Further work will be needed to identify and evaluate competing possibilities as regulations, attitudes to risk and technologies evolve.

Interleukin-1beta gene polymorphisms in Taiwanese patients with gout.

PubMed

Chen, Man-Ling; Huang, Chung-Ming; Tsai, Chang-Hai; Tsai, Fuu-Jen

2005-04-01

The purpose of this study was to examine whether interleukin-1 beta (IL-1beta) promoter and exon 5 gene polymorphisms are markers of susceptibility or clinical manifestations in Taiwanese patients with gout. The study included 196 patients in addition to 103 unrelated healthy control subjects living in central Taiwan. From genomic DNA, polymorphisms of the gene for IL-1beta promoter and IL-1beta exon 5 were typed. Allelic frequencies were compared between the two groups, and the relationship between allelic frequencies and clinical manifestations of gout was evaluated. No significant differences were observed in the allelic frequencies of the IL-1beta promoter between patients with gout and healthy control subjects. Additionally, we did not detect any association of the IL-1beta promoter genotype with the clinical and laboratory profiles of gout patients. However, there was a significant difference between the two groups in terms of hypertriglyceridemia (P=0.0004, chi(2)=12.52, OR 7.14, 95%CI 0.012-0.22). There was also a significant difference in the genotype of IL-1beta exon 5 polymorphism between patients with and without hypertriglyceridemia. Results of the present study suggest that polymorphisms of the IL-1beta promoter and IL-1beta exon 5 are not related to gout patients in central Taiwan.

The role of incretin-based therapies in prediabetes: a review.

PubMed

Ahmadieh, Hala; Azar, Sami T

2014-12-01

Prediabetes, a high-risk state for future development of diabetes, is prevalent globally. Abnormalities in the incretin axis are important in the progression of B-cell failure in type 2 diabetes. Incretin based therapy was found to improve B cell mass and glycaemic control in addition to having multiple beneficial effects on the systolic and diastolic blood pressure, weight loss in addition to their other beneficial effects on the liver and cardiovascular system. In prediabetes, several well-designed preventive trials have shown that lifestyle and pharmacologic interventions such as metformin, thiazolidinediones (TZD), acarbose and, nateglinide and orlistat, are effective in reducing diabetes development. In recent small studies, incretin based therapy (DPP IV inhibitors and GLP-1 agonists) have also been extended to patients with prediabetes since it was shown to better preserve B-cell function and mass in animal studies and in clinical trials and it was also shown to help maintain good long term metabolic control. Because of the limited studies and clinical experience, their side effects and costs currently guidelines do not recommend incretin-based therapies as an option for treatment in patients with prediabetes. With future clinical trials and studies they may be recommended for patients with impaired fasting glucose or impaired glucose tolerance. Copyright © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Urea and Ammonia Metabolism and the Control of Renal Nitrogen Excretion.

PubMed

Weiner, I David; Mitch, William E; Sands, Jeff M

2015-08-07

Renal nitrogen metabolism primarily involves urea and ammonia metabolism, and is essential to normal health. Urea is the largest circulating pool of nitrogen, excluding nitrogen in circulating proteins, and its production changes in parallel to the degradation of dietary and endogenous proteins. In addition to serving as a way to excrete nitrogen, urea transport, mediated through specific urea transport proteins, mediates a central role in the urine concentrating mechanism. Renal ammonia excretion, although often considered only in the context of acid-base homeostasis, accounts for approximately 10% of total renal nitrogen excretion under basal conditions, but can increase substantially in a variety of clinical conditions. Because renal ammonia metabolism requires intrarenal ammoniagenesis from glutamine, changes in factors regulating renal ammonia metabolism can have important effects on glutamine in addition to nitrogen balance. This review covers aspects of protein metabolism and the control of the two major molecules involved in renal nitrogen excretion: urea and ammonia. Both urea and ammonia transport can be altered by glucocorticoids and hypokalemia, two conditions that also affect protein metabolism. Clinical conditions associated with altered urine concentrating ability or water homeostasis can result in changes in urea excretion and urea transporters. Clinical conditions associated with altered ammonia excretion can have important effects on nitrogen balance. Copyright © 2015 by the American Society of Nephrology.

Urea and Ammonia Metabolism and the Control of Renal Nitrogen Excretion

PubMed Central

Mitch, William E.; Sands, Jeff M.

2015-01-01

Renal nitrogen metabolism primarily involves urea and ammonia metabolism, and is essential to normal health. Urea is the largest circulating pool of nitrogen, excluding nitrogen in circulating proteins, and its production changes in parallel to the degradation of dietary and endogenous proteins. In addition to serving as a way to excrete nitrogen, urea transport, mediated through specific urea transport proteins, mediates a central role in the urine concentrating mechanism. Renal ammonia excretion, although often considered only in the context of acid-base homeostasis, accounts for approximately 10% of total renal nitrogen excretion under basal conditions, but can increase substantially in a variety of clinical conditions. Because renal ammonia metabolism requires intrarenal ammoniagenesis from glutamine, changes in factors regulating renal ammonia metabolism can have important effects on glutamine in addition to nitrogen balance. This review covers aspects of protein metabolism and the control of the two major molecules involved in renal nitrogen excretion: urea and ammonia. Both urea and ammonia transport can be altered by glucocorticoids and hypokalemia, two conditions that also affect protein metabolism. Clinical conditions associated with altered urine concentrating ability or water homeostasis can result in changes in urea excretion and urea transporters. Clinical conditions associated with altered ammonia excretion can have important effects on nitrogen balance. PMID:25078422

Verbal Memory Impairment in Polydrug Ecstasy Users: A Clinical Perspective

PubMed Central

Kuypers, Kim P. C.; Theunissen, Eef L.; van Wel, Janelle H. P.; de Sousa Fernandes Perna, Elizabeth B.; Linssen, Anke; Sambeth, Anke; Schultz, Benjamin G.; Ramaekers, Johannes G.

2016-01-01

Background Ecstasy use has been associated with short-term and long-term memory deficits on a standard Word Learning Task (WLT). The clinical relevance of this has been debated and is currently unknown. The present study aimed at evaluating the clinical relevance of verbal memory impairment in Ecstasy users. To that end, clinical memory impairment was defined as decrement in memory performance that exceeded the cut-off value of 1.5 times the standard deviation of the average score in the healthy control sample. The primary question was whether being an Ecstasy user (E-user) was predictive of having clinically deficient memory performance compared to a healthy control group. Methods WLT data were pooled from four experimental MDMA studies that compared memory performance during placebo and MDMA intoxication. Control data were taken from healthy volunteers with no drug use history who completed the WLT as part of a placebo-controlled clinical trial. This resulted in a sample size of 65 E-users and 65 age- and gender-matched healthy drug-naïve controls. All participants were recruited by similar means and were tested at the same testing facilities using identical standard operating procedures. Data were analyzed using linear mixed-effects models, Bayes factor, and logistic regressions. Results Findings were that verbal memory performance of placebo-treated E-users did not differ from that of controls, and there was substantial evidence in favor of the null hypothesis. History of use was not predictive of memory impairment. During MDMA intoxication of E-users, verbal memory was impaired. Conclusion The combination of the acute and long-term findings demonstrates that, while clinically relevant memory impairment is present during intoxication, it is absent during abstinence. This suggests that use of Ecstasy/MDMA does not lead to clinically deficient memory performance in the long term. Additionally, it has to be investigated whether the current findings apply to more complex cognitive measures in diverse ‘user categories’ using a combination of genetics, imaging techniques and neuropsychological assessments. PMID:26907605

Subjective memory complaints, depressive symptoms and cognition in patients attending a memory outpatient clinic.

PubMed

Lehrner, J; Moser, D; Klug, S; Gleiß, A; Auff, E; Dal-Bianco, P; Pusswald, G

2014-03-01

The goals of this study were to establish prevalence of subjective memory complaints (SMC) and depressive symptoms (DS) and their relation to cognitive functioning and cognitive status in an outpatient memory clinic cohort. Two hundred forty-eight cognitively healthy controls and 581 consecutive patients with cognitive complaints who fulfilled the inclusion criteria were included in the study. A statistically significant difference (p < 0.001) between control group and patient group regarding mean SMC was detected. 7.7% of controls reported a considerable degree of SMC, whereas 35.8% of patients reported considerable SMC. Additionally, a statistically significant difference (p < 0.001) between controls and patient group regarding Beck depression score was detected. 16.6% of controls showed a clinical relevant degree of DS, whereas 48.5% of patients showed DS. An analysis of variance revealed a statistically significant difference across all four groups (control group, SCI group, naMCI group, aMCI group) (p < 0.001). Whereas 8% of controls reported a considerable degree of SMC, 34% of the SCI group, 31% of the naMCI group, and 54% of the aMCI group reported considerable SMC. A two-factor analysis of variance with the factors cognitive status (controls, SCI group, naMCI group, aMCI group) and depressive status (depressed vs. not depressed) and SMC as dependent variable revealed that both factors were significant (p < 0.001), whereas the interaction was not (p = 0.820). A large proportion of patients seeking help in a memory outpatient clinic report considerable SMC, with an increasing degree from cognitively healthy elderly to aMCI. Depressive status increases SMC consistently across groups with different cognitive status.

[Biodegradable synthetic implant materials : clinical applications and immunological aspects].

PubMed

Witte, F; Calliess, T; Windhagen, H

2008-02-01

In the last decade biodegradable synthetic implant materials have been established for various clinical applications. Ceramic materials such as calcium phosphate, bioglass and polymers are now routinely used as degradable implants in the clinical practice. Additionally these materials are now also used as coating materials or as microspheres for controlled drug release and belong to a series of examples for applications as scaffolds for tissue engineering. Because immense local concentrations of degradation products are produced during biodegradation, this review deals with the question whether allergic immune reactions, which have been reported for classical metallic and organic implant materials, also play a role in the clinical routine for synthetic biodegradable materials. Furthermore, possible explanatory theories will be developed to clarify the lack of clinical reports on allergy or sensitization to biodegradable synthetic materials.

A pilot study of pulmonary rehabilitation and chest physiotherapy versus chest physiotherapy alone in bronchiectasis.

PubMed

Mandal, P; Sidhu, M K; Kope, L; Pollock, W; Stevenson, L M; Pentland, J L; Turnbull, K; Mac Quarrie, S; Hill, A T

2012-12-01

The aim of our study was to assess the efficacy of pulmonary rehabilitation in addition to regular chest physiotherapy in non cystic fibrosis bronchiectasis. Thirty patients with clinically significant bronchiectasis and limited exercise tolerance were randomized into either the control group receiving chest physiotherapy (8 weeks) or into the intervention group, receiving pulmonary rehabilitation in addition to chest physiotherapy (8 weeks). Both groups were encouraged to maintain their exercise program and or chest physiotherapy, following completion of the study. End of training (8 weeks) No improvement in control group. In the intervention group, incremental shuttle walk test (ISWT) improved by 56.7 m (p = 0.03), endurance walk test (EWT) by 193.3 m (p = 0.01), Leicester Cough Questionnaire (LCQ) improved by 2.6 units (p < 0.001) and St. George's Respiratory Questionnaire (SGRQ) by 8 units (p < 0.001). At 20 weeks (12 weeks post end of training) No improvement in control group. In the intervention group, ISWT improved by 80 m (p = 0.04) and EWT by 247.5 m (p = 0.003). LCQ improved by 4.4 units (p < 0.001) and SGRQ by 4 units (p < 0.001). Pulmonary rehabilitation in addition to regular chest physiotherapy, improves exercise tolerance and health related quality of life in non cystic fibrosis bronchiectasis and the benefit was sustained at 12 weeks post end of pulmonary rehabilitation. Clinical trials regn no. NCT00868075. Copyright © 2012 Elsevier Ltd. All rights reserved.

Factors associated with suicide: Case-control study in South Tyrol.

PubMed

Giupponi, Giancarlo; Innamorati, Marco; Baldessarini, Ross J; De Leo, Diego; de Giovannelli, Francesca; Pycha, Roger; Conca, Andreas; Girardi, Paolo; Pompili, Maurizio

2018-01-01

As suicide is related to many factors in addition to psychiatric illness, broad and comprehensive risk-assessment for risk of suicide is required. This study aimed to differentiate nondiagnostic risk factors among suicides versus comparable psychiatric patients without suicidal behavior. We carried out a pilot, case-control comparison of 131 cases of suicide in South Tyrol matched for age and sex with 131 psychiatric controls, using psychological autopsy methods to evaluate differences in clinically assessed demographic, social, and clinical factors, using bivariate conditional Odds Risk comparisons followed by conditional regression modeling controlled for ethnicity. Based on multivariable conditional regression modeling, suicides were significantly more likely to have experienced risk factors, ranking as: [a] family history of suicide or attempt≥[b] recent interpersonal stressors≥[c] childhood traumatic events≥[d] lack of recent clinician contacts≥[e] previous suicide attempt≥[f] non-Italian ethnicity, but did not differ in education, marital status, living situation, or employment, nor by psychiatric or substance-abuse diagnoses. Both recent and early factors were associated with suicide, including lack of recent clinical care, non-Italian cultural subgroup-membership, familial suicidal behavior, and recent interpersonal distress. Copyright © 2017 Elsevier Inc. All rights reserved.

Extrastriatal changes in patients with late-onset glutaric aciduria type I highlight the risk of long-term neurotoxicity.

PubMed

Boy, Nikolas; Heringer, Jana; Brackmann, Renate; Bodamer, Olaf; Seitz, Angelika; Kölker, Stefan; Harting, Inga

2017-04-24

Without neonatal initiation of treatment, 80-90% of patients with glutaric aciduria type 1 (GA1) develop striatal injury during the first six years of life resulting in a complex, predominantly dystonic movement disorder. Onset of motor symptoms may be acute following encephalopathic crisis or insidious without apparent crisis. Additionally, so-called late-onset GA1 has been described in single patients diagnosed after the age of 6 years. With the aim of better characterizing and understanding late-onset GA1 we analyzed clinical findings, biochemical phenotype, and MRI changes of eight late-onset patients and compared these to eight control patients over the age of 6 years with early diagnosis and start of treatment. No late-onset or control patient had either dystonia or striatal lesions on MRI. All late-onset (8/8) patients were high excretors, but only four of eight control patients. Two of eight late-onset patients were diagnosed after the age of 60 years, presenting with dementia, tremor, and epilepsy, while six were diagnosed before the age of 30 years: Three were asymptomatic mothers identified by following a positive screening result in their newborns and three had non-specific general symptoms, one with additional mild neurological deficits. Frontotemporal hypoplasia and white matter changes were present in all eight and subependymal lesions in six late-onset patients. At comparable age a greater proportion of late-onset patients had (non-specific) clinical symptoms and possibly subependymal nodules compared to control patients, in particular in comparison to the four clinically and MR-wise asymptomatic low-excreting control patients. While clinical findings are non-specific, frontotemporal hypoplasia and subependymal nodules are characteristic MRI findings of late-onset GA1 and should trigger diagnostic investigation for this rare disease. Apart from their apparent non-susceptibility for striatal injury despite lack of treatment, patients with late-onset GA1 are not categorically different from early treated control patients. Differences between late-onset patients and early treated control patients most likely reflect greater cumulative neurotoxicity in individuals remaining undiagnosed and untreated for years, even decades as well as the higher long-term risk of high excretors for intracerebral accumulation of neurotoxic metabolites compared to low excretors.

Primacy of the 3B approach to control risk factors for cardiovascular disease in type 2 diabetes patients.

PubMed

Ji, Linong; Hu, Dayi; Pan, Changyu; Weng, Jianping; Huo, Yong; Ma, Changsheng; Mu, Yiming; Hao, Chuanming; Ji, Qiuhe; Ran, Xingwu; Su, Benli; Zhuo, Hanjing; Fox, Keith A A; Weber, Michael; Zhang, Danyi

2013-10-01

Individually, diabetes mellitus, hypertension, and dyslipidemia have been shown to increase the risk of cardiovascular disease. While traditional management of Type 2 diabetes has focused mainly on glycemic control, robust evidence supports the integration of hypertension and dyslipidemia management to reduce the risk of cardiovascular disease. The primary objective of this study was to assess the level of control of blood glucose, blood pressure, and blood lipids (3Bs) among patients with type 2 diabetes. An additional objective was to investigate the impact of hospital type, physician specialty, treatment pattern, and patient profile on clinical outcomes. This was a cross-sectional, multicenter observational study. A nationally representative sample of outpatients with established type 2 diabetes were enrolled at hospitals representative of geographic regions, tiers, and physician specialties in China. Main clinical measurements were the levels of glycosylated hemoglobin (HbA1c), blood pressure, and total serum cholesterol in reference to target goals. A total of 25,817 adults with type 2 diabetes (mean age 62.6 years, 47% male) were enrolled at 104 hospitals. Seventy-two percent reported comorbid hypertension, dyslipidemia, or both. Patients with concurrent type 2 diabetes, hypertension, and dyslipidemia were 6 times more likely to report a prior history of cardiovascular disease compared with those with type 2 diabetes alone. The mean HbA1c level was 7.6%. While 47.7%, 28.4%, and 36.1% of patients achieved the individual target goals for control of blood glucose (HbA1c <7%), blood pressure (systolic blood pressure <130 mm Hg, diastolic blood pressure <80 mm Hg), and blood lipids (total cholesterol <4.5 mmol/L), respectively, only 5.6% achieved all 3 target goals. Lower body mass index (<24 kg/m(2)), no active smoking or drinking, higher education, and diabetes duration <5 years were independent predictors of better cardiovascular disease risk control. Achieving adequate control of risk factors for cardiovascular disease in patients with type 2 diabetes remains a clinical challenge. Interventions to achieve control of 3Bs coupled with modification of additional cardiovascular disease predictors are crucial for optimization of clinical outcomes in patients with type 2 diabetes. Copyright © 2013 Elsevier Inc. All rights reserved.

Characterization and classification of lupus patients based on plasma thermograms

PubMed Central

Chaires, Jonathan B.; Mekmaysy, Chongkham S.; DeLeeuw, Lynn; Sivils, Kathy L.; Harley, John B.; Rovin, Brad H.; Kulasekera, K. B.; Jarjour, Wael N.

2017-01-01

Objective Plasma thermograms (thermal stability profiles of blood plasma) are being utilized as a new diagnostic approach for clinical assessment. In this study, we investigated the ability of plasma thermograms to classify systemic lupus erythematosus (SLE) patients versus non SLE controls using a sample of 300 SLE and 300 control subjects from the Lupus Family Registry and Repository. Additionally, we evaluated the heterogeneity of thermograms along age, sex, ethnicity, concurrent health conditions and SLE diagnostic criteria. Methods Thermograms were visualized graphically for important differences between covariates and summarized using various measures. A modified linear discriminant analysis was used to segregate SLE versus control subjects on the basis of the thermograms. Classification accuracy was measured based on multiple training/test splits of the data and compared to classification based on SLE serological markers. Results Median sensitivity, specificity, and overall accuracy based on classification using plasma thermograms was 86%, 83%, and 84% compared to 78%, 95%, and 86% based on a combination of five antibody tests. Combining thermogram and serology information together improved sensitivity from 78% to 86% and overall accuracy from 86% to 89% relative to serology alone. Predictive accuracy of thermograms for distinguishing SLE and osteoarthritis / rheumatoid arthritis patients was comparable. Both gender and anemia significantly interacted with disease status for plasma thermograms (p<0.001), with greater separation between SLE and control thermograms for females relative to males and for patients with anemia relative to patients without anemia. Conclusion Plasma thermograms constitute an additional biomarker which may help improve diagnosis of SLE patients, particularly when coupled with standard diagnostic testing. Differences in thermograms according to patient sex, ethnicity, clinical and environmental factors are important considerations for application of thermograms in a clinical setting. PMID:29149219

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

PubMed Central

Geraghty, Adam W A; Stanford, Rosie; Stuart, Beth; Little, Paul; Roberts, Lisa C; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine M; Turner, David; Malakan, Wansida; Leigh, Linda; Yardley, Lucy

2018-01-01

Objective To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. Design and setting A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. Participants Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. Interventions The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. Outcomes The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. Results Primary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%. Conclusions This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. Trial registration number ISRCTN31034004; Results. PMID:29525768

Implementing standardized performance indicators to improve hypertension control at both the population and healthcare organization levels

PubMed Central

Campbell, Norm; Ordunez, Pedro; Jafe, Marc G.; Orias, Marcelo; DiPete, Donald J.; Patel, Pragna; Khan, Nadia; Onuma, Oyere; Lackland, Daniel T.

2017-01-01

The ability to reliably evaluate the impact of interventions and changes in hypertension prevalence and control is critical if the burden of hypertension-related disease is to be reduced. Previously, a World Hypertension League Expert Committee made recommendations to standardize the reporting of population blood pressure surveys. We have added to those recommendations and also provide modified recommendations from a Pan American Health Organization expert meeting for “performance indicators” to be used to evaluate clinical practices. Core indicators for population surveys are recommended to include: (1) mean systolic blood pressure and (2) mean diastolic blood pressure, and the prevalences of: (3) hypertension, (4) awareness of hypertension, (5) drug-treated hypertension, and (6) drug-treated and controlled hypertension. Core indicators for clinical registries are recommended to include: (1) the prevalence of diagnosed hypertension and (2) the ratio of diagnosed hypertension to that expected by population surveys, and the prevalences of: (3) controlled hypertension, (4) lack of blood pressure measurement within a year in people diagnosed with hypertension, and (5) missed visits by people with hypertension. Definitions and additional indicators are provided. Widespread adoption of standardized population and clinical hypertension performance indicators could represent a major step forward in the effort to control hypertension. PMID:28191704

Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

PubMed Central

Ratanasiripong, Paul; Ratanasiripong, Nop; Kathalae, Duangrat

2012-01-01

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession. PMID:22811932

[Clinical evaluation of "All-on-Four" provisional prostheses reinforced with carbon fibers].

PubMed

Li, Bei-bei; Lin, Ye; Cui, Hong-yan; Hao, Qiang; Xu, Jia-bin; Di, Ping

2016-02-18

To assess the clinical effects of carbon fiber reinforcement on the "All-on-Four" provisional prostheses. Provisional prostheses were divided into control group and carbon fiber reinforcing group according to whether carbon fiber reinforcement was used in the provisional prostheses base resin. In our study, a total of 60 patients (32 males and 28 females) with 71 provisional prostheses(28 maxilla and 43 mandible)were enrolled between April 2008 and December 2012 for control group; a total of 23 patients (13 males and 10 females) with 28 provisional prostheses (9 maxillas and 19 mandibles) were enrolled between January 2013 and March 2014 for carbon fiber reinforcing group. The information of provisional prostheses in the patients was recorded according to preoperative examination. We used the date of definitive prosthesis restoration as the cut-off point, observing whether fracture occurred on the provisional prostheses in the two groups. Additionally we observed whether fiber exposure occurred on the tissue surface of the provisional prostheses and caused mucosal irritation. The interface between the denture base resin and the fibers was examined using scanning electron microscopy (SEM). The age [(57.3 ± 10.1) years vs.(55.1 ± 11.4) years], gender (32 males and 28 females vs. 13 males and 10 females), maxilla and mandible distributions (28 maxillas and 43 mandibles vs. 9 maxillas and 19 mandibles), the number of extraction jaws (46 vs. 23), the average using time [(7.8 ± 1.3) months vs. (7.5 ± 1.1) months], and the opposing dentition distributions of provisional prostheses of the patients showed no significant differences between the control and reinforcing groups. There were 21(29.6%) fractures that occurred on the 71 provisional prostheses in the control group; there was no fracture that occurred on the 28 provisional prosthesesin the carbon fiber reinforcing group. The fracture rate of the carbon fiber reinforcing group was significantly lower than that of the control group (P=0.001). No carbon fiber exposure and mucosal irritation were observed from clinical examination.SEM revealed relatively continuous contact between the fiber and acrylic resin, and the resin particles adhered on the surface of the carbon fibers. The addition of carbon fibers between abutments placed on "All-on-Four" provisional fixed denture base resin may be clinically effective in preventing "All-on-Four" denture fracture and can provide several advantages for clinical use.

Aerobic training for improved memory in patients with stress-related exhaustion: a randomized controlled trial.

PubMed

Eskilsson, Therese; Slunga Järvholm, Lisbeth; Malmberg Gavelin, Hanna; Stigsdotter Neely, Anna; Boraxbekk, Carl-Johan

2017-09-02

Patients with stress-related exhaustion suffer from cognitive impairments, which often remain after psychological treatment or work place interventions. It is important to find effective treatments that can address this problem. Therefore, the aim of this study was to investigate the effects on cognitive performance and psychological variables of a 12-week aerobic training program performed at a moderate-vigorous intensity for patients with exhaustion disorder who participated in a multimodal rehabilitation program. In this open-label, parallel, randomized and controlled trial, 88 patients diagnosed with exhaustion disorder participated in a 24-week multimodal rehabilitation program. After 12 weeks in the program the patients were randomized to either a 12-week aerobic training intervention or to a control group with no additional training. Primary outcome measure was cognitive function, and secondary outcome measures were psychological health variables and aerobic capacity. In total, 51% patients in the aerobic training group and 78% patients in the control group completed the intervention period. The aerobic training group significantly improved in maximal oxygen uptake and episodic memory performance. No additional improvement in burnout, depression or anxiety was observed in the aerobic group compared with controls. Aerobic training at a moderate-vigorous intensity within a multimodal rehabilitation program for patients with exhaustion disorder facilitated episodic memory. A future challenge would be the clinical implementation of aerobic training and methods to increase feasibility in this patient group. ClinicalTrials.gov: NCT03073772 . Retrospectively registered 21 February 2017.

Overlap between Parkinson disease and Alzheimer disease in ABCA7 functional variants

PubMed Central

Nuytemans, Karen; Maldonado, Lizmarie; Ali, Aleena; John-Williams, Krista; Beecham, Gary W.; Martin, Eden; Scott, William K.

2016-01-01

Objective: Given their reported function in phagocytosis and clearance of protein aggregates in Alzheimer disease (AD), we hypothesized that variants in ATP-binding cassette transporter A7 (ABCA7) might be involved in Parkinson disease (PD). Methods: ABCA7 variants were identified using whole-exome sequencing (WES) on 396 unrelated patients with PD and 222 healthy controls. In addition, we used the publicly available WES data from the Parkinson's Progression Markers Initiative (444 patients and 153 healthy controls) as a second, independent data set. Results: We observed a higher frequency of loss-of-function (LOF) variants and rare putative highly functional variants (Combined Annotation Dependent Depletion [CADD] >20) in clinically diagnosed patients with PD than in healthy controls in both data sets. Overall, we identified LOF variants in 11 patients and 1 healthy control (odds ratio [OR] 4.94, Fisher exact p = 0.07). Four of these variants have been previously implicated in AD risk (p.E709AfsX86, p.W1214X, p.L1403RfsX7, and rs113809142). In addition, rare variants with CADD >20 were observed in 19 patients vs 3 healthy controls (OR 2.85, Fisher exact p = 0.06). Conclusion: The presence of ABCA7 LOF variants in clinically defined PD suggests that they might be risk factors for neurodegeneration in general, especially those variants hallmarked by protein aggregation. More studies will be needed to evaluate the overall impact of this transporter in neurodegenerative disease. PMID:27066581

Comprehensive attention to oral health in early childhood: a longitudinal evaluation of the Infant Clinic Program of the Federal University of Rio Grande do Sul, Brazil.

PubMed

Figueiredo, Márcia Cançado; Guarienti, Cinthya Aline D; Michel, Jorge Artur; Sampaio, Mircelei Saldanha

2008-01-01

The Infant Clinic Program believes that oral care should begin within the first days of life in order to guarantee good oral health throughout life; however it has been observed that many dental professionals are not trained attend to this segment of the population. The purpose of the Infant Clinic course is to offer the theoretical and practical knowledge that dentists need to know in order to offer education, prevention and curative treatments, providing comprehensive attention to infants and young children. To evaluate the effectiveness of this Program, a longitudinal study was conducted with the children who participated in the Program during 2004 and 2005. The analysis was performed by first defining the profiles of 303 children before they came to the Infant Clinic, and comparing their oral status in 2004 and at the end of 2005 (12 months, Chi-square test, p < 0.01). Of the 303 children observed in 2004, 72.87% came to the clinic for maintenance of oral health, compared to 14.83% who had caries lesions. During the first clinical examination (2004), it was observed that 57% of the children had good plaque control, while 33% of children had poor or very bad plaque control. After 12 months (2005), an increase in good plaque control was observed in the children (77.28% with good plaque control, and 22.72%poor or very bad plaque control) (p < 0.01). Through the treatment of active lesions, we verified a decrease in active lesions (from 82% to 32%) (p < 0.01). These results show the effectiveness of the program's education, preventive and curative procedures. In addition to the positive experience of the Infant Clinic program, it was concluded that, with the support of treatment and parental education regarding healthy diet and oral hygiene for children, preventive procedures and curative treatment of existing lesions, oral health promotion for very young children was in fact achieved.

Health locus of control as manifested in individuals attending a state-run medical dispensary in northern India.

PubMed

Berg, Michael B; Anshika, Avi

2017-04-01

To investigate the health locus of control (HLOC) beliefs of patients and visitors at a free, state-run medical clinic in Faridabad, India, in order to establish a norm for this population and to explore potential associations between the different categories of causal health beliefs. Participants (110 men, 96 women) were interviewed in Hindi and asked a shortened version of the Multidimensional Health Locus of Control Scale assessing both internal HLOC and three aspects of external HLOC (chance, powerful others, and God). Additional variables of interest included a Traditional Values Scale, a measure of spirituality, an assessment of health status, and demographic information including gender, age, employment status, and religion. Participants rated the external-God factor as a stronger determinant of their health than the internal or other external HLOC factors. Internal HLOC was positively correlated with external HLOC in terms of chance and the role of powerful others and these associations were strongest for the most interdependent participants (i.e. women and the unemployed). For patients and visitors at the Faridabad clinic, religion played a significant role in their causal health beliefs. In addition, internal HLOC was positively associated with aspects of external locus of control, suggesting that causal health beliefs were viewed in a holistic, integrated fashion. Interventions based on these findings are suggested.

How do practising clinicians and students apply newly learned causal information about mental disorders?

PubMed

de Kwaadsteniet, Leontien; Kim, Nancy S; Yopchick, Jennelle E

2013-02-01

New causal theories explaining the aetiology of psychiatric disorders continuously appear in the literature. How might such new information directly impact clinical practice, to the degree that clinicians are aware of it and accept it? We investigated whether expert clinical psychologists and students use new causal information about psychiatric disorders according to rationalist norms in their diagnostic reasoning. Specifically, philosophical and Bayesian analyses suggest that it is rational to draw stronger inferences about the presence of a disorder when a client's presenting symptoms are from disparate locations in a causal theory of the disorder than when they are from proximal locations. In a controlled experiment, we presented experienced clinical psychologists and students with recently published causal theories for different disorders; specifically, these theories proposed how the symptoms of each disorder stem from a root cause. Participants viewed hypothetical clients with presenting proximal or diverse symptoms, and indicated either the likelihood that the client has the disorder, or what additional information they would seek out to help inform a diagnostic decision. Clinicians and students alike showed a strong preference for diverse evidence, over proximal evidence, in making diagnostic judgments and in seeking additional information. They did not show this preference in the control condition, in which they gave their own opinions prior to learning the causal information. These findings suggest that experienced clinical psychologists and students are likely to use newly learned causal knowledge in a normative, rational way in diagnostic reasoning. © 2011 Blackwell Publishing Ltd.

Clinical efficacy and safety of bevacizumab monotherapy in patients with metastatic melanoma: predictive importance of induced early hypertension.

PubMed

Schuster, Cornelia; Eikesdal, Hans P; Puntervoll, Hanne; Geisler, Jürgen; Geisler, Stephanie; Heinrich, Daniel; Molven, Anders; Lønning, Per E; Akslen, Lars A; Straume, Oddbjørn

2012-01-01

VEGF driven angiogenesis plays a key role in cancer progression. We determined the clinical efficacy of bevacizumab monotherapy in patients with metastatic melanoma. Thirty-five patients with metastatic melanoma in progression were enrolled in this phase II, single arm clinical trial. Each patient received bevacizumab monotherapy 10 mg/kg q14 d until intolerable toxicity or disease progression occurred. Clinical efficacy was evaluated as objective response, disease control (DC), and survival. We observed one complete (3%) and 5 partial (14%) responses. In addition, 5 patients experienced stable disease >6 months (14%) while 24 patients had progressive disease (PD, 69%), corresponding to a total DC at 6 months in 11 out of 35 patients (31%). Median progression free survival (PFS) was 2.14 months and median overall survival (OS) was 9 months (1.12-49). Seven of the 11 patients experiencing DC developed early hypertension (<2 months) compared to 3/24 of patients with PD (P = 0.001), and hypertension was associated with PFS (P = 0.005) and OS (P = 0.013). Bevacizumab monotherapy demonstrated promising clinical efficacy in patients with metastatic melanoma with disease control in 31% of the patients. Induced early hypertension was a marker for clinical efficacy of bevacizumab. ClinicalTrials.gov NCT00139360.

Sporotrichosis: an update on epidemiology, etiopathogenesis, laboratory and clinical therapeutics.

PubMed

Orofino-Costa, Rosane; Macedo, Priscila Marques de; Rodrigues, Anderson Messias; Bernardes-Engemann, Andréa Reis

2017-01-01

In the late 90's there was a change in both the route of transmission and the people at risk for sporotrichosis. This zoonotic cat-man alternative transmission route elicited changes in strategies to control the epidemic. There was a progressive increase in the number of cases involving especially children and the elderly. In addition to becoming hyperendemic, uncommon clinical pictures like immunoreactive clinical presentations or severe systemic cases have emerged. New species were identified and classified through molecular tools using more virulent clinical isolates, like S. brasiliensis, compared to the environmental isolates. Likewise, different species of Sporothrix have been associated with different geographic regions. The serological and molecular techniques are used as an auxiliary tool for the diagnosis and/or for species identification, although the isolation and the identification of Sporothrix spp. in clinical specimen is still the gold standard. Currently sporotrichosis epidemics requires the knowledge of the epidemiological-molecular profile to control the disease and the specific treatment. Itraconazole, potassium iodide, terfinafine, and amphotericin B are the available drugs in Brazil to treat sporotrichosis. The drug of choice, its posology, and treatment duration vary according to the clinical presentation, the Sporothrix species, and host immune status. New treatment choices, including a vaccine, are being developed; nevertheless, more clinical trials are required to confirm its efficacy.

Sporotrichosis: an update on epidemiology, etiopathogenesis, laboratory and clinical therapeutics*

PubMed Central

Orofino-Costa, Rosane; de Macedo, Priscila Marques; Rodrigues, Anderson Messias; Bernardes-Engemann, Andréa Reis

2017-01-01

In the late 90's there was a change in both the route of transmission and the people at risk for sporotrichosis. This zoonotic cat-man alternative transmission route elicited changes in strategies to control the epidemic. There was a progressive increase in the number of cases involving especially children and the elderly. In addition to becoming hyperendemic, uncommon clinical pictures like immunoreactive clinical presentations or severe systemic cases have emerged. New species were identified and classified through molecular tools using more virulent clinical isolates, like S. brasiliensis, compared to the environmental isolates. Likewise, different species of Sporothrix have been associated with different geographic regions. The serological and molecular techniques are used as an auxiliary tool for the diagnosis and/or for species identification, although the isolation and the identification of Sporothrix spp. in clinical specimen is still the gold standard. Currently sporotrichosis epidemics requires the knowledge of the epidemiological-molecular profile to control the disease and the specific treatment. Itraconazole, potassium iodide, terfinafine, and amphotericin B are the available drugs in Brazil to treat sporotrichosis. The drug of choice, its posology, and treatment duration vary according to the clinical presentation, the Sporothrix species, and host immune status. New treatment choices, including a vaccine, are being developed; nevertheless, more clinical trials are required to confirm its efficacy. PMID:29166494

Patient-centered Medical Home Capability and Clinical Performance in HRSA-supported Health Centers

PubMed Central

Shi, Leiyu; Lock, Diana C.; Lee, De-Chih; Lebrun-Harris, Lydie A.; Chin, Marshall H.; Chidambaran, Preeta; Nocon, Robert S.; Zhu, Jinsheng; Sripipatana, Alek

2015-01-01

Objectives To evaluate the relationship between Patient-centered Medical Home (PCMH) model adoption in health centers (HCs) and clinical performance measures and to determine if adoption of PCMH characteristics is associated with better clinical performance. Research Design Data came from the Health Resources and Services Administration’s 2009 Uniform Data System and the 2009 Commonwealth Fund National Survey of Federally Qualified Health Centers. Clinical performance measures included 2 process measures (childhood immunization and cervical cancer screening) and 2 outcome measures (hypertension control and diabetes control). Total and subscale PCMH scores were regressed on the clinical performance measures, adjusting for patient, provider, financial, and institutional characteristics. Results The findings showed different directional relationships, with some PCMH domains (care management, test/referral tracking, quality improvement, and external coordination) showing little or no effect on outcome measures of interest, 1 domain (access/communication) associated with improved outcomes, and 1 domain (patient tracking/registry) associated with worse outcomes. Conclusions This study is among the first to examine the association between PCMH transformation and clinical performance in HCs, providing an understanding of the impact of PCMH adoption within safety-net settings. The mixed results highlight the importance of examining relationships between specific PCMH domains and specific clinical quality measures, in addition to analyzing overall PCMH scores which could yield distorted findings. PMID:25793267

Identification of seven new prostate cancer susceptibility loci through a genome-wide association study.

PubMed

Eeles, Rosalind A; Kote-Jarai, Zsofia; Al Olama, Ali Amin; Giles, Graham G; Guy, Michelle; Severi, Gianluca; Muir, Kenneth; Hopper, John L; Henderson, Brian E; Haiman, Christopher A; Schleutker, Johanna; Hamdy, Freddie C; Neal, David E; Donovan, Jenny L; Stanford, Janet L; Ostrander, Elaine A; Ingles, Sue A; John, Esther M; Thibodeau, Stephen N; Schaid, Daniel; Park, Jong Y; Spurdle, Amanda; Clements, Judith; Dickinson, Joanne L; Maier, Christiane; Vogel, Walther; Dörk, Thilo; Rebbeck, Timothy R; Cooney, Kathleen A; Cannon-Albright, Lisa; Chappuis, Pierre O; Hutter, Pierre; Zeegers, Maurice; Kaneva, Radka; Zhang, Hong-Wei; Lu, Yong-Jie; Foulkes, William D; English, Dallas R; Leongamornlert, Daniel A; Tymrakiewicz, Malgorzata; Morrison, Jonathan; Ardern-Jones, Audrey T; Hall, Amanda L; O'Brien, Lynne T; Wilkinson, Rosemary A; Saunders, Edward J; Page, Elizabeth C; Sawyer, Emma J; Edwards, Stephen M; Dearnaley, David P; Horwich, Alan; Huddart, Robert A; Khoo, Vincent S; Parker, Christopher C; Van As, Nicholas; Woodhouse, Christopher J; Thompson, Alan; Christmas, Tim; Ogden, Chris; Cooper, Colin S; Southey, Melissa C; Lophatananon, Artitaya; Liu, Jo-Fen; Kolonel, Laurence N; Le Marchand, Loic; Wahlfors, Tiina; Tammela, Teuvo L; Auvinen, Anssi; Lewis, Sarah J; Cox, Angela; FitzGerald, Liesel M; Koopmeiners, Joseph S; Karyadi, Danielle M; Kwon, Erika M; Stern, Mariana C; Corral, Roman; Joshi, Amit D; Shahabi, Ahva; McDonnell, Shannon K; Sellers, Thomas A; Pow-Sang, Julio; Chambers, Suzanne; Aitken, Joanne; Gardiner, R A Frank; Batra, Jyotsna; Kedda, Mary Anne; Lose, Felicity; Polanowski, Andrea; Patterson, Briony; Serth, Jürgen; Meyer, Andreas; Luedeke, Manuel; Stefflova, Klara; Ray, Anna M; Lange, Ethan M; Farnham, Jim; Khan, Humera; Slavov, Chavdar; Mitkova, Atanaska; Cao, Guangwen; Easton, Douglas F

2009-10-01

Prostate cancer (PrCa) is the most frequently diagnosed cancer in males in developed countries. To identify common PrCa susceptibility alleles, we previously conducted a genome-wide association study in which 541,129 SNPs were genotyped in 1,854 PrCa cases with clinically detected disease and in 1,894 controls. We have now extended the study to evaluate promising associations in a second stage in which we genotyped 43,671 SNPs in 3,650 PrCa cases and 3,940 controls and in a third stage involving an additional 16,229 cases and 14,821 controls from 21 studies. In addition to replicating previous associations, we identified seven new prostate cancer susceptibility loci on chromosomes 2, 4, 8, 11 and 22 (with P = 1.6 x 10(-8) to P = 2.7 x 10(-33)).

Identification of seven new prostate cancer susceptibility loci through a genome-wide association study

PubMed Central

Eeles, Rosalind A.; Kote-Jarai, Zsofia; Olama, Ali Amin Al; Giles, Graham G.; Guy, Michelle; Severi, Gianluca; Muir, Kenneth; Hopper, John L.; Henderson, Brian E.; Haiman, Christopher A.; Schleutker, Johanna; Hamdy, Freddie C.; Neal, David E.; Donovan, Jenny L.; Stanford, Janet L.; Ostrander, Elaine A.; Ingles, Sue A.; John, Esther M.; Thibodeau, Stephen N.; Schaid, Daniel; Park, Jong Y.; Spurdle, Amanda; Clements, Judith; Dickinson, Joanne L.; Maier, Christiane; Vogel, Walther; Dörk, Thilo; Rebbeck, Timothy R.; Cooney, Kathleen A.; Cannon-Albright, Lisa; Chappuis, Pierre O.; Hutter, Pierre; Zeegers, Maurice; Kaneva, Radka; Zhang, Hong-Wei; Lu, Yong-Jie; Foulkes, William D.; English, Dallas R.; Leongamornlert, Daniel A.; Tymrakiewicz, Malgorzata; Morrison, Jonathan; Ardern-Jones, Audrey T.; Hall, Amanda L.; O’Brien, Lynne T.; Wilkinson, Rosemary A.; Saunders, Edward J.; Page, Elizabeth C.; Sawyer, Emma J.; Edwards, Stephen M.; Dearnaley, David P.; Horwich, Alan; Huddart, Robert A.; Khoo, Vincent S.; Parker, Christopher C.; Van As, Nicholas; Woodhouse, Christopher J.; Thompson, Alan; Christmas, Tim; Ogden, Chris; Cooper, Colin S.; Southey, Melissa C.; Lophatananon, Artitaya; Liu, Jo-Fen; Kolonel, Laurence N.; Le Marchand, Loic; Wahlfors, Tiina; Tammela, Teuvo L.; Auvinen, Anssi; Lewis, Sarah J.; Cox, Angela; FitzGerald, Liesel M.; Koopmeiners, Joseph S.; Karyadi, Danielle M.; Kwon, Erika M.; Stern, Mariana C.; Corral, Roman; Joshi, Amit D.; Shahabi, Ahva; McDonnell, Shannon K.; Sellers, Thomas A; Pow-Sang, Julio; Chambers, Suzanne; Aitken, Joanne; Gardiner, R.A. (Frank); Batra, Jyotsna; Kedda, Mary Anne; Lose, Felicity; Polanowski, Andrea; Patterson, Briony; Serth, Jürgen; Meyer, Andreas; Luedeke, Manuel; Stefflova, Klara; Ray, Anna M.; Lange, Ethan M.; Farnham, Jim; Khan, Humera; Slavov, Chavdar; Mitkova, Atanaska; Cao, Guangwen; Easton, Douglas F.

2010-01-01

Prostate cancer (PrCa) is the most frequently diagnosed male cancer in developed countries. To identify common PrCa susceptibility alleles, we have previously conducted a genome-wide association study in which 541, 129 SNPs were genotyped in 1,854 PrCa cases with clinically detected disease and 1,894 controls. We have now evaluated promising associations in a second stage, in which we genotyped 43,671 SNPs in 3,650 PrCa cases and 3,940 controls, and a third stage, involving an additional 16,229 cases and 14,821 controls from 21 studies. In addition to previously identified loci, we identified a further seven new prostate cancer susceptibility loci on chromosomes 2, 4, 8, 11, and 22 (P=1.6×10−8 to P=2.7×10−33). PMID:19767753

Negative affect predicts social functioning across schizophrenia and bipolar disorder: Findings from an integrated data analysis

PubMed Central

Grove, Tyler B.; Tso, Ivy F.; Chun, Jinsoo; Mueller, Savanna A.; Taylor, Stephan F.; Ellingrod, Vicki L.; McInnis, Melvin G.; Deldin, Patricia J.

2016-01-01

Most people with a serious mental illness experience significant functional impairment despite ongoing pharmacological treatment. Thus, in order to improve outcomes, a better understanding of functional predictors is needed. This study examined negative affect, a construct comprised of negative emotional experience, as a predictor of social functioning across serious mental illnesses. One hundred twenty-seven participants with schizophrenia, 113 with schizoaffective disorder, 22 with psychotic disorder not otherwise specified, 58 with bipolar disorder, and 84 healthy controls (N=404) completed self-report negative affect measures. Elevated levels of negative affect were observed in clinical participants compared with healthy controls. For both clinical and healthy control participants, negative affect measures were significantly correlated with social functioning, and consistently explained significant amounts of variance in functioning. For clinical participants, this relationship persisted even after accounting for cognition and positive/negative symptoms. The findings suggest that negative affect is a strong predictor of outcome across these populations and treatment of serious mental illnesses should target elevated negative affect in addition to cognition and positive/negative symptoms. PMID:27416540

Evaluating information prescriptions in two clinical environments*

PubMed Central

Oliver, Kathleen Burr; Lehmann, Harold P; Wolff, Antonio C; Davidson, Laurie W; Donohue, Pamela K; Gilmore, Maureen M; Craven, Catherine K.

2011-01-01

Objective: The research sought to evaluate whether providing personalized information services by libraries can improve satisfaction with information services for specific types of patients. Methods: Adult breast cancer (BrCa) clinic patients and mothers of inpatient neonatal intensive care unit (NICU) patients were randomized to receive routine information services (control) or an IRx intervention. Results: The BrCa trial randomized 211 patients and the NICU trial, 88 mothers. The BrCa trial showed no statistically significant differences in satisfaction ratings between the treatment and control groups. The IRx group in the NICU trial reported higher satisfaction than the control group regarding information received about diagnosis, treatments, respiratory tradeoffs, and medication tradeoffs. BrCa patients posed questions to librarians more frequently than did NICU mothers, and a higher percentage reported using the website. Questions asked of the librarians by BrCa patients were predominantly clinical and focused on the areas of treatment and side effects. Conclusions: Study results provide some evidence to support further efforts to both implement information prescription projects in selected settings and to conduct additional research on the costs and benefits of services. PMID:21753916

Healthcare-associated infection surveillance and bedside alerts.

PubMed

Adlassnig, Klaus-Peter; Berger, Angelika; Koller, Walter; Blacky, Alexander; Mandl, Harald; Unterasinger, Lukas; Rappelsberger, Andrea

2014-01-01

Expectations and requirements concerning the identification and surveillance of healthcare-associated infections (HAIs) are increasing, calling for differentiated automated approaches. In an attempt to bridge the "definition swamp" of these infections and serve the needs of different users, we improved the monitoring of nosocomial infections (MONI) software to create better surveillance reports according to consented national and international definitions, as well as produce infection overviews on complex clinical matters including alerts for the clinician's ward and bedside work. MONI contains and processes surveillance definitions for intensive-care-unit-acquired infections from the European Centre for Disease Prevention and Control, Sweden, as well as the Centers for Disease Control and Prevention, USA. The latest release of MONI also includes KISS criteria of the German National Reference Center for Surveillance of Nosocomial Infections. In addition to these "classic" surveillance criteria, clinical alert criteria--which are similar but not identical to the surveillance criteria--were established together with intensivists. This is an important step to support both infection control and clinical personnel; and--last but not least--to foster co-evolution of the two groups of definitions: surveillance and alerts.

Negative affect predicts social functioning across schizophrenia and bipolar disorder: Findings from an integrated data analysis.

PubMed

Grove, Tyler B; Tso, Ivy F; Chun, Jinsoo; Mueller, Savanna A; Taylor, Stephan F; Ellingrod, Vicki L; McInnis, Melvin G; Deldin, Patricia J

2016-09-30

Most people with a serious mental illness experience significant functional impairment despite ongoing pharmacological treatment. Thus, in order to improve outcomes, a better understanding of functional predictors is needed. This study examined negative affect, a construct comprised of negative emotional experience, as a predictor of social functioning across serious mental illnesses. One hundred twenty-seven participants with schizophrenia, 113 with schizoaffective disorder, 22 with psychosis not otherwise specified, 58 with bipolar disorder, and 84 healthy controls (N=404) completed self-report negative affect measures. Elevated levels of negative affect were observed in clinical participants compared with healthy controls. For both clinical and healthy control participants, negative affect measures were significantly correlated with social functioning, and consistently explained significant amounts of variance in functioning. For clinical participants, this relationship persisted even after accounting for cognition and positive/negative symptoms. The findings suggest that negative affect is a strong predictor of outcome across these populations and treatment of serious mental illnesses should target elevated negative affect in addition to cognition and positive/negative symptoms. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

PubMed

Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

2008-06-01

To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

A Quasi-Experimental Study Examining New York State's Tobacco-Free Regulation: Effects on Clinical Practice Behaviors

PubMed Central

Laschober, Tanja C.

2013-01-01

Background On July 24, 2008, New York State (NYS) became the first state to require all state-funded or state-certified substance use disorder (SUD) treatment organizations to be 100% tobacco-free and offer tobacco cessation (TC) treatment. Methods The current study used a quasi-experimental, non-equivalent control group design with a pretest and posttest to examine the effect of the NYS tobacco-free regulation on three clinical practice behaviors (use of TC-related intake procedures, use of guideline recommended counseling for TC, and pharmacotherapy availability) in a diverse sample of SUD treatment programs. Repeated cross-sectional data were collected from NYS counselors (experimental group) and non-NYS counselors (control group) approximately 4 months pre-regulation (N = 282 and 659, respectively) and 10-12 months post-regulation (N = 364 and 733, respectively). Results Using mixed-effects models, results at pre-regulation indicate no group differences in the three clinical practice behaviors. However, significant post-regulation effects were found such that the experimental group reports greater use of TC-related intake procedures, guideline recommended counseling, and availability of pharmacotherapy than the control group. Additionally, the experimental but not the control group shows increases in all three clinical practice behaviors from pre-regulation to post-regulation. Conclusions We conclude that the NYS tobacco-free regulation had a significant and positive effect on promoting patient TC efforts among counselors. PMID:23428317

Is ginger beneficial for nausea and vomiting? An update of the literature.

PubMed

Marx, Wolfgang; Kiss, Nicole; Isenring, Liz

2015-06-01

Nausea and vomiting can pose a significant burden to patients in a variety of clinical settings. Previous evidence suggests that ginger may be an effective treatment for these symptoms; however, current evidence has been mixed. This article discusses recent clinical trials that have investigated ginger as a treatment for multiple types of nausea and vomiting. In addition, the potential mechanisms of action of ginger will be discussed. This article identified nine studies and seven reviews that investigated ginger for morning sickness, postoperative nausea and vomiting, chemotherapy-induced, and antiretroviral-induced nausea and vomiting. All studies reported that ginger provided a significant reduction in nausea and vomiting; however, the clinical relevance of some studies is less certain. Common limitations within the literature include the lack of standardized extracts, poorly controlled or blinded studies, and limited sample size. In addition, recent evidence has provided further support for 5-HT3 receptor antagonism as a mechanism by which ginger may exert its potentially beneficial effect on nausea and vomiting. The results of studies in this article suggest that ginger is a promising treatment for nausea and vomiting in a variety of clinical settings and possesses a clinically relevant mechanism. However, further studies are required to address the limitations in the current clinical literature before firm recommendations for its use can be made.

Clinical simulation training improves the clinical performance of Chinese medical students

PubMed Central

Zhang, Ming-ya; Cheng, Xin; Xu, An-ding; Luo, Liang-ping; Yang, Xuesong

2015-01-01

Background Modern medical education promotes medical students’ clinical operating capacity rather than the mastery of theoretical knowledge. To accomplish this objective, clinical skill training using various simulations was introduced into medical education to cultivate creativity and develop the practical ability of students. However, quantitative analysis of the efficiency of clinical skill training with simulations is lacking. Methods In the present study, we compared the mean scores of medical students (Jinan University) who graduated in 2013 and 2014 on 16 stations between traditional training (control) and simulative training groups. In addition, in a clinical skill competition, the objective structured clinical examination (OSCE) scores of participating medical students trained using traditional and simulative training were compared. The data were statistically analyzed and qualitatively described. Results The results revealed that simulative training could significantly enhance the graduate score of medical students compared with the control. The OSCE scores of participating medical students in the clinical skill competition, trained using simulations, were dramatically higher than those of students trained through traditional methods, and we also observed that the OSCE marks were significantly increased for the same participant after simulative training for the clinical skill competition. Conclusions Taken together, these data indicate that clinical skill training with a variety of simulations could substantially promote the clinical performance of medical students and optimize the resources used for medical education, although a precise analysis of each specialization is needed in the future. PMID:26478142

To Assess the Association between Glucose Metabolism and Ectopic Lipid Content in Different Clinical Classifications of PCOS

PubMed Central

Göbl, Christian S.; Ott, Johannes; Bozkurt, Latife; Feichtinger, Michael; Rehmann, Victoria; Cserjan, Anna; Heinisch, Maike; Steinbrecher, Helmut; JustKukurova, Ivica; Tuskova, Radka; Leutner, Michael; Vytiska-Binstorfer, Elisabeth; Kurz, Christine; Weghofer, Andrea; Tura, Andrea; Egarter, Christian; Kautzky-Willer, Alexandra

2016-01-01

Aims There are emerging data indicating an association between PCOS (polycystic ovary syndrome) and metabolic derangements with potential impact on its clinical presentation. This study aims to evaluate the pathophysiological processes beyond PCOS with particular focus on carbohydrate metabolism, ectopic lipids and their possible interaction. Differences between the two established classifications of the disease should be additionally evaluated. Methods A metabolic characterization was performed in 53 untreated PCOS patients as well as 20 controls including an extended oral glucose tolerance test (OGTT, to assess insulin sensitivity, secretion and ß-cell function) in addition to a detailed examination of ectopic lipid content in muscle and liver by nuclear magnetic resonance spectroscopy. Results Women with PCOS classified by the original NIH 1990 definition showed a more adverse metabolic risk profile compared to women characterized by the additional Rotterdam 2003 phenotypes. Subtle metabolic derangements were observed in both subgroups, including altered shapes of OGTT curves, impaired insulin action and hyperinsulinemia due to increased secretion and attenuated hepatic extraction. No differences were observed for ectopic lipids between the groups. However, particularly hepatocellular lipid content was significantly related to clinical parameters of PCOS like whole body insulin sensitivity, dyslipidemia and free androgen index. Conclusions Subtle alterations in carbohydrate metabolism are present in both PCOS classifications, but more profound in subjects meeting the NIH 1990 criteria. Females with PCOS and controls did not differ in ectopic lipids, however, liver fat was tightly related to hyperandrogenism and an adverse metabolic risk profile. PMID:27505055

The treatment of severe premenstrual syndrome with goserelin with and without 'add-back' estrogen therapy: a placebo-controlled study.

PubMed

Leather, A T; Studd, J W; Watson, N R; Holland, E F

1999-02-01

The study aimed to determine if the addition of daily low-dose oral estrogen with a cyclical progestogen given to young women using a depot gonadotropin-releasing hormone (GnRH) analog implant for the treatment of their premenstrual syndrome (PMS) would affect the clinical outcome. In a double-blind placebo-controlled study in a specialist premenstrual syndrome clinic setting, 60 women aged between 20 and 45 years were randomized to one of three treatment groups: Group A (placebo implant four weekly + placebo tablets daily), Group B (goserelin 3.6 mg implant four weekly + estradiol valerate 2 mg daily with norethisterone 5 mg from days 21-28 of a 28-day cycle) or Group C (goserelin 3.6 mg implant four weekly + placebo tablets daily). Differences between PMS scores at 2, 4 and 6 months were compared with pretreatment values. There was a significant improvement in PMS scores in Group C (Zoladex + placebo) after 2, 4 and 6 months of treatment when compared to pretreatment values and Group A (placebo + placebo). The addition of a low-dose oral estrogen with a cyclical progestogen to GnRH analog treatment (Group B) resulted in a less dramatic response when compared to pretreatment values and no significant improvement when compared to Group A (placebo + placebo) at 2, 4 and 6 months of treatment. The addition of a low-dose oral estrogen with a cyclical progestogen to depot GnRH analog therapy in the treatment of PMS reduces the clinical response.

Emerging technology for advancing the treatment of epilepsy using a dynamic control framework.

PubMed

Stanslaski, Scott; Giftakis, John; Stypulkowski, Paul; Carlson, Dave; Afshar, Pedram; Cong, Peng; Denison, Timothy

2011-01-01

We briefly describe a dynamic control system framework for neuromodulation for epilepsy, with an emphasis on its practical challenges and the preliminary validation of key prototype technologies in a chronic animal model. The current state of neuromodulation can be viewed as a classical dynamic control framework such that the nervous system is the classical "plant", the neural stimulator is the controller/actuator, clinical observation, patient diaries and/or measured bio-markers are the sensor, and clinical judgment applied to these sensor inputs forms the state estimator. Technology can potentially address two main factors contributing to the performance limitations of existing systems: "observability," the ability to observe the state of the system from output measurements, and "controllability," the ability to drive the system to a desired state. In addition to improving sensors and actuator performance, methods and tools to better understand disease state dynamics and state estimation are also critical for improving therapy outcomes. We describe our preliminary validation of key "observability" and "controllability" technology blocks using an implanted research tool in an epilepsy disease model. This model allows for testing the key emerging technologies in a representative neural network of therapeutic importance. In the future, we believe these technologies might enable both first principles understanding of neural network behavior for optimizing therapy design, and provide a practical pathway towards clinical translation.

Improving the Fiscal Sustainability of Teaching Clinics at Dental Schools.

PubMed

Reinhardt, John W

2015-12-01

Educational patient care clinics are becoming an increasingly important source of revenue for dental schools. Revenue from clinics can help offset the rising cost of dental education. In addition, those clinics represent a source of income over which the schools have reasonably direct control. Recently, a group of nine U.S. dental schools conducted a detailed financial survey of their clinics and shared the confidential results with each other. The purpose of their analysis was to develop benchmarks for key factors related to clinical financial productivity and expenses and to define best practices to guide improvements at each school. The survey found significant variations among the nine schools in revenue produced by predoctoral students and by postdoctoral residents. There were similar variations for levels of clinical staffing. By sharing the results of the survey with each other, the individual schools gained a strong understanding of the business strengths or weakness of their own clinical programs. That information gave each school's leaders the opportunity to investigate how they might improve their clinical fiscal sustainability.

Threshold-Switchable Particles (TSPs) to Control Internal Hemorrhage

DTIC Science & Technology

2015-12-01

Many nudix-type phosphatases are clinically important enzymes and their overexpression can be markers of disease. Nudt2 (Apah1), for example, is an Ap4A ...hydrolase that, when overexpressed in breast cancer, correlates with poor prognosis.26 In addition to processing Ap4A , Nudt2 can hydrolyze long-chain

A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

PubMed

Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

2012-04-25

The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: -2.1, SD 3.3 kg, enhanced: -3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: -2.0, SD 3.5 cm, enhanced: -3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: -0.01, SD 0.02, enhanced: -0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

One-appointment endodontic therapy: biological considerations.

PubMed

Lin, Louis M; Lin, Jarshen; Rosenberg, Paul A

2007-11-01

The authors conducted a literature review to present the best available biological evidence concerning one-appointment endodontic therapy for asymptomatic teeth with apical periodontitis. Because of recent advances in technology, such as rotary engines and nickel-titanium instruments, some practitioners are performing one-appointment endodontic therapy for asymptomatic teeth with apical periodontitis. The authors reviewed the literature, which revealed only a small number of randomized, controlled clinical trials that have been conducted on one-appointment versus multiple-appointment endodontic therapy. As the apical canal preparation is enlarged, a greater percentage of bacteria is eradicated from infected root canals. In addition, sufficiently large apical root canal enlargement facilitates the delivery of antimicrobial irrigant to the apical portion of the canal. However, an association between positive or negative preobturation root canal culture results and the outcome of endodontic treatment has not been well-established. The best available evidence, based on a systematic literature review, indicates that one-appointment endodontic therapy may be feasible in selected cases of apical periodontitis in asymptomatic teeth. However, additional randomized, controlled clinical trials are required.

Sensorimotor System Measurement Techniques

PubMed Central

Riemann, Bryan L.; Myers, Joseph B.; Lephart, Scott M.

2002-01-01

Objective: To provide an overview of currently available sensorimotor assessment techniques. Data Sources: We drew information from an extensive review of the scientific literature conducted in the areas of proprioception, neuromuscular control, and motor control measurement. Literature searches were conducted using MEDLINE for the years 1965 to 1999 with the key words proprioception, somatosensory evoked potentials, nerve conduction testing, electromyography, muscle dynamometry, isometric, isokinetic, kinetic, kinematic, posture, equilibrium, balance, stiffness, neuromuscular, sensorimotor, and measurement. Additional sources were collected using the reference lists of identified articles. Data Synthesis: Sensorimotor measurement techniques are discussed with reference to the underlying physiologic mechanisms, influential factors and locations of the variable within the system, clinical research questions, limitations of the measurement technique, and directions for future research. Conclusions/Recommendations: The complex interactions and relationships among the individual components of the sensorimotor system make measuring and analyzing specific characteristics and functions difficult. Additionally, the specific assessment techniques used to measure a variable can influence attained results. Optimizing the application of sensorimotor research to clinical settings can, therefore, be best accomplished through the use of common nomenclature to describe underlying physiologic mechanisms and specific measurement techniques. PMID:16558672

Transversal changes, space closure, and efficiency of conventional and self-ligating appliances : A quantitative systematic review.

PubMed

Yang, Xianrui; Xue, Chaoran; He, Yiruo; Zhao, Mengyuan; Luo, Mengqi; Wang, Peiqi; Bai, Ding

2018-01-01

Self-ligating brackets (SLBs) were compared to conventional brackets (CBs) regarding their effectiveness on transversal changes and space closure, as well as the efficiency of alignment and treatment time. All previously published randomized controlled clinical trials (RCTs) dealing with SLBs and CBs were searched via electronic databases, e.g., MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, World Health Organization International Clinical Trials Registry Platform, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. In addition, relevant journals were searched manually. Data extraction was performed independently by two reviewers and assessment of the risk of bias was executed using Cochrane Collaboration's tool. Discrepancies were resolved by discussion with a third reviewer. Meta-analyses were conducted using Review Manager (version 5.3). A total of 976 patients in 17 RCTs were included in the study, of which 11 could be produced quantitatively and 2 showed a low risk of bias. Meta-analyses were found to favor CB for mandibular intercanine width expansion, while passive SLBs were more effective in posterior expansion. Moreover, CBs had an apparent advantage during short treatment periods. However, SLBs and CBs did not differ in closing spaces. Based on current clinical evidence obtained from RCTs, SLBs do not show clinical superiority compared to CBs in expanding transversal dimensions, space closure, or orthodontic efficiency. Further high-level studies involving randomized, controlled, clinical trials are warranted to confirm these results.

[The assessment of the clinical effectiveness of fenspiride for the treatment of acute obstruction of the Eustachian tube].

PubMed

Fedin, A V

2015-01-01

The objective of the present study was to estimate the clinical effectiveness of fenspiride used to correct the obstruction of the Eustachian tube in 80 patients presenting with acute tubootitis and exudative otitis media. The algorithm of the examination included the evaluation of the severity of subjective clinical symptoms based on the relevant analog-visual scale, results of tonal audiometry, and tympanometry. The control group was comprised of 34 patients treated with antibacterial preparations, topical decongestants, and transtubal administration of glucocorticoids. The study group included 46 patients who received fenspiride at a dose of 80 mg thrice daily in addition to the above pharmacotherapy. The severity of clinical symptoms in the patients treated with fenspiride decreased faster than in the control subjects. The frequency analysis of dynamics of the air-bone gaps on the audiometric curves revealed the significantly more intensive recovery of the hearing function in the patients treated by basal pharmacotherapy in the combination with fenspiride. Type A tympanograms predominated on day 7 after the onset of the conservative treatment with the use of fenspiride whereas type C tympanograms continued to predominate in the patients of the control group. It is concluded that the introduction of fenspiride into combined therapy of acute tubootitis and exudative otitis media promotes the normalization of the ventilation and drainage functions and relieves the severity of subjective clinical symptoms.

Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: Protocol for a three-armed randomized clinical trial

PubMed Central

2011-01-01

Background Hip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise. Methods/Design This is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months. Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion. Discussion To our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis. Trial registration ClinicalTrials NCT01039337 PMID:21542914

Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: protocol for a three-armed randomized clinical trial.

PubMed

Poulsen, Erik; Christensen, Henrik W; Roos, Ewa M; Vach, Werner; Overgaard, Søren; Hartvigsen, Jan

2011-05-04

Hip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise. This is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months.Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion. To our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis. ClinicalTrials NCT01039337.

Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial.

PubMed

Cardaropoli, Daniele; Tamagnone, Lorenzo; Roffredo, Alessandro; Gaveglio, Lorena

2012-03-01

Connective tissue graft (CTG) plus coronally advanced flap (CAF) is the reference therapy for root coverage. The aim of the present study is to evaluate the use of a porcine collagen matrix (PCM) plus CAF as an alternative to CTG+CAF for the treatment of gingival recessions (REC), in a prospective randomized, controlled clinical trial. Eighteen adult patients participated in this study. The patients presented 22 single Miller's Class I or II REC, randomly assigned to the test (PCM+CAF) or control (CTG+CAF) group. REC, probing depth, clinical attachment level (CAL), and width of keratinized tissue (KG) were evaluated at 12 months. In addition, the gingival thickness (GT) was measured 1mm apical to the bottom of the sulcus. At 12 months, mean REC was 0.23 mm for test sites and 0.09 mm for control sites (P <0.01), whereas percentage of root coverage was 94.32% and 96.97%, respectively. CAL gain was 2.41 mm in test sites and 2.95 mm in control sites (P <0.01). KG gain was 1.23 mm in the test group and 1.27 mm in the control group (P <0.01). In test sites, GT changed from 0.82 to 1.82 mm, and in control sites, from 0.86 to 2.09 mm (P <0.01). Within the limits of the study, both treatment procedures resulted in significant reduction in REC at 12 months. No statistically significant differences were found between PCM+CAF and CTG+CAF with regard to any clinical parameter. The collagen matrix represents a possible alternative to CTG.

Asthma control and need for future asthma controller therapy among inner-city Hispanic asthmatic children engaged in a pediatric asthma disease management program (the Breathmobile program, Mobile Asthma Care for Kids Network).

PubMed

Scott, Lyne; Li, Marilyn; Thobani, Salima; Nichols, Breck; Morphew, Tricia; Kwong, Kenny Yat-Choi

2016-08-01

To determine whether significant numbers of asthmatic children with initially rated intermittent asthma later suffer poor asthma control and require the addition of controller medications. Inner-city Hispanic children were followed prospectively in an asthma-specific disease management system (Breathmobile) for a period of 2 years. Clinical asthma symptoms, morbidity treatment, and demographic data were collected at each visit. Treatment was based upon National Heart, Lung, and Blood Institute (NHLBI) Expert Panel Report 3 asthma guidelines. Primary outcome was percentage of patients with intermittent asthma who had not well or poorly controlled asthma during subsequent visits and required controller agents. Secondary outcomes were factors associated with the maintenance of asthma control. About 30.9% of the patients with initial rating of intermittent asthma had not well controlled and poorly controlled asthma during subsequent visits and required the addition of controller agents. Factors associated with good asthma control were compliance, no previous emergency room visits and previous visit during spring season. Asthmatic children with intermittent asthma often lose asthma control and require controller therapy. This justifies asthma guideline recommendations to assess asthma control at follow-up visits and adjust therapy accordingly.

Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial.

PubMed

de Waal, Y C M; Raghoebar, G M; Meijer, H J A; Winkel, E G; van Winkelhoff, A J

2015-09-01

The objective of this randomized, double-blind, controlled trial was to evaluate the clinical, radiographic, and microbiological effects of implant surface decontamination with a 2% chlorhexidine (CHX) solution in comparison with a 0.12% chlorhexidine + 0.05% cetylpyridinium chloride (CPC) solution during resective surgical peri-implantitis treatment. Forty-four patients (108 implants) with peri-implantitis were treated with resective surgical treatment consisting of bone re-contouring, surface debridement and chemical decontamination, and apically repositioned flap. Patients were randomly allocated to decontamination with a 2% CHX solution (test group) or 0.12% CHX + 0.05% CPC (control group). Clinical and radiographic parameters were recorded before treatment (baseline), and at 3, 6, and 12 months after treatment. Microbiological parameters were recorded during surgery. Multilevel analysis showed no significant differences in bleeding, suppuration, probing pocket depth, and radiographic bone loss between control and test group over three follow-up measurements (3, 6, and 12 months) from baseline. Both decontamination procedures resulted in significant reductions in anaerobic bacterial counts on the implant surface, but no significant difference was noted between control and test group (mean log 3.37 ± 2.34 vs. 3.65 ± 2.87, P = 0.99). The use of a 2% CHX solution for implant surface decontamination during resective peri-implantitis therapy does not lead to improved clinical, radiographic, or microbiological results compared with a 0.12% CHX + 0.05% CPC solution. Overall, the additional use of CHX reduces anaerobic bacterial load on the implant surface better than mechanical debridement alone, but does not seem to enhance clinical treatment outcomes (ClinicalTrials.gov number NCT01852253). © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The efficacy and safety of neoadjuvant chemotherapy +/- letrozole in postmenopausal women with locally advanced breast cancer: a randomized phase III clinical trial.

PubMed

Mohammadianpanah, Mohammad; Ashouri, Yaghoub; Hoseini, Sare; Amadloo, Niloofar; Talei, Abdolrasoul; Tahmasebi, Sedigheh; Nasrolahi, Hamid; Mosalaei, Ahmad; Omidvari, Shapour; Ansari, Mansour; Mosleh-Shirazi, Mohammad Amin

2012-04-01

This two-arm randomized clinical study aimed to evaluate the efficacy and safety of neoadjuvant concurrent chemotherapy and letrozole in postmenopausal women with locally advanced breast carcinoma. One hundred and one postmenopausal women aged 50-83 years with pathologically proven locally advanced (clinical stage T3, T4 and/or N2, N3) breast cancer were randomly assigned to receive neoadjuvant chemotherapy alone (control arm, n = 51) or neoadjuvant chemotherapy concurrent with letrozole 2.5 mg (study arm, n = 50). Chemotherapy consisted of a median 4 (range 3-5) cycles of intravenous 5-fluorouracil 600 mg/m(2), doxorubicin 60 mg/m(2), and cyclophosphamide 600 mg/m(2), every three weeks. All patients subsequently underwent modified radical mastectomy approximately two weeks after the last cycle of chemotherapy. Pathologic complete response rates were 25.5% and 10.2% in the study and the control group, respectively (P = 0.049). Similarly, clinical complete response rates were 27.6% and 10.2% in the study and the control group, respectively (P = 0.037). In the subgroup analysis of hormone receptor-positive cases, the complete response rates were more prominent in study group compared with control group. Common treatment-related side effects such as nausea, vomiting, bone marrow suppression, and mucositis were similar in both groups, but hot flush was more prevalent in study group compared with control group (P = 0.023). The addition of letrozole concurrently with neoadjuvant chemotherapy provides a higher clinical and pathologic response rates with acceptable toxicity compared with chemotherapy alone in postmenopausal women with locally advanced sensitive breast cancer.

Effects of team-based learning on problem-solving, knowledge and clinical performance of Korean nursing students.

PubMed

Kim, Hae-Ran; Song, Yeoungsuk; Lindquist, Ruth; Kang, Hee-Young

2016-03-01

Team-based learning (TBL) has been used as a learner-centered teaching strategy in efforts to improve students' problem-solving, knowledge and practice performance. Although TBL has been used in nursing education in Korea for a decade, few studies have studied its effects on Korean nursing students' learning outcomes. To examine the effects of TBL on problem-solving ability and learning outcomes (knowledge and clinical performance) of Korean nursing students. Randomized controlled trial. 63 third-year undergraduate nursing students attending a single university were randomly assigned to the TBL group (n=32), or a control group (n=31). The TBL and control groups attended 2h of class weekly for 3weeks. Three scenarios with pulmonary disease content were employed in both groups. However, the control group received lectures and traditional case study teaching/learning strategies instead of TBL. A questionnaire of problem-solving ability was administered at baseline, prior to students' exposure to the teaching strategies. Students' problem-solving ability, knowledge of pulmonary nursing care, and clinical performance were assessed following completion of the three-week pulmonary unit. After the three-week educational interventions, the scores on problem-solving ability in the TBL group were significantly improved relative to that of the control group (t=10.89, p<.001). In addition, there were significant differences in knowledge, and in clinical performance with standardized patients between the two groups (t=2.48, p=.016, t=12.22, p<.001). This study demonstrated that TBL is an effective teaching strategy to enhance problem-solving ability, knowledge and clinical performance. More research on other specific learning outcomes of TBL for nursing students is recommended. Copyright © 2015 Elsevier Ltd. All rights reserved.

Is cost effectiveness sustained after weekend inpatient rehabilitation? 12 month follow up from a randomized controlled trial.

PubMed

Brusco, Natasha Kareem; Watts, Jennifer J; Shields, Nora; Taylor, Nicholas F

2015-04-18

Our previous work showed that providing additional rehabilitation on a Saturday was cost effective in the short term from the perspective of the health service provider. This study aimed to evaluate if providing additional rehabilitation on a Saturday was cost effective at 12 months, from a health system perspective inclusive of private costs. Cost effectiveness analyses alongside a single-blinded randomized controlled trial with 12 months follow up inclusive of informal care. Participants were adults admitted to two publicly funded inpatient rehabilitation facilities. The control group received usual care rehabilitation services from Monday to Friday and the intervention group received usual care plus additional Saturday rehabilitation. Incremental cost effectiveness ratios were reported as cost per quality adjusted life year (QALY) gained and for a minimal clinical important difference (MCID) in functional independence. A total of 996 patients [mean age 74 years (SD 13)] were randomly assigned to the intervention (n = 496) or control group (n = 500). The intervention was associated with improvements in QALY and MCID in function, as well as a non-significant reduction in cost from admission to 12 months (mean difference (MD) AUD$6,325; 95% CI -4,081 to 16,730; t test p = 0.23 and MWU p = 0.06), and a significant reduction in cost from admission to 6 months (MD AUD$6,445; 95% CI 3,368 to 9,522; t test p = 0.04 and MWU p = 0.01). There is a high degree of certainty that providing additional rehabilitation services on Saturday is cost effective. Sensitivity analyses varying the cost of informal carers and self-reported health service utilization, favored the intervention. From a health system perspective inclusive of private costs the provision of additional Saturday rehabilitation for inpatients is likely to have sustained cost savings per QALY gained and for a MCID in functional independence, for the inpatient stay and 12 months following discharge, without a cost shift into the community. Australian and New Zealand Clinical Trials Registry November 2009 ACTRN12609000973213.

Rotator cuff healing after needling of a calcific deposit using platelet-rich plasma augmentation: a randomized, prospective clinical trial.

PubMed

Verhaegen, Filip; Brys, Peter; Debeer, Philippe

2016-02-01

Arthroscopic needling of a rotator cuff calcification is a highly reliable operation in terms of pain relief and return of function. However, during the needling process, a cuff defect is created. Little is known about the evolution of this defect. We conducted a prospective, randomized controlled clinical trial to investigate the evolution of the aforementioned defect and the role of platelet-rich plasma (PRP) augmentation in this healing process. Patients were randomized to either group 1 (PRP, n = 20) or group 2 (no PRP [control group], n = 20). Patients in group 1 received a perioperative PRP infiltration at the rotator cuff defect, whereas the control group did not. Patients were assessed clinically preoperatively and postoperatively at 6 weeks, 3 and 6 months, and 1 year. The Constant score, Simple Shoulder Test, and QuickDASH (short version of Disabilities of the Arm, Shoulder and Hand questionnaire) were used as outcome measures. The evolution of the cuff defect was evaluated on sonography at 3 and 6 months and with magnetic resonance imaging after 1 year. All patients improved significantly after surgery (P < .05). There was no difference in clinical outcome or rotator cuff healing between groups. We observed a high rate of persistent rotator cuff defects after 1 year in both groups. The presence of residual cuff defects did not influence the clinical outcome. Arthroscopic needling is an operation with a predictive, good clinical outcome. We found a high rate of persistent rotator cuff defects after 1 year. This study could not identify any beneficial effect of the addition of PRP on rotator cuff healing. Level II; Randomized Controlled Trial; Treatment Study. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome.

PubMed

Minten, Michiel J M; Heesterbeek, Petra J C; Spruit, Maarten

2016-08-01

Background and purpose - Additional screw fixation of the all-polyethylene press-fit RM cup (Mathys) has no additional value for migration, in the first 2 years after surgery. However, the medium-term and long-term effects of screw fixation remain unclear. We therefore evaluated the influence of screw fixation on migration, wear, and clinical outcome at 6.5 years using radiostereometric analysis (RSA). Patients and methods - This study involved prolonged follow-up from a previous randomized controlled trial (RCT). We analyzed RSA radiographs taken at baseline and at 1-, 2-, and 6.5-year follow-up. Cup migration and wear were assessed using model-based RSA software. Wear was calculated as translation of the femoral head model in relation to the cup model. Total translation, rotation, and wear were calculated mathematically from results of the orthogonal components. Results - 27 patients (15 with screw fixation and 12 without) were available for follow-up at 6.5 (5.6-7.2) years. Total translation (0.50 mm vs. 0.56 mm) and rotation (1.01 degrees vs. 1.33 degrees) of the cup was low, and was not significantly different between the 2 groups. Wear increased over time, and was similar between the 2 groups (0.58 mm vs. 0.53 mm). Wear rate (0.08 mm/year vs. 0.09 mm/year) and clinical outcomes were also similar. Interpretation - Our results indicate that additional screw fixation of all-polyethylene press-fit RM cups has no additional value regarding medium-term migration and clinical outcome. The wear rate was low in both groups.

Accounting for dropout reason in longitudinal studies with nonignorable dropout.

PubMed

Moore, Camille M; MaWhinney, Samantha; Forster, Jeri E; Carlson, Nichole E; Allshouse, Amanda; Wang, Xinshuo; Routy, Jean-Pierre; Conway, Brian; Connick, Elizabeth

2017-08-01

Dropout is a common problem in longitudinal cohort studies and clinical trials, often raising concerns of nonignorable dropout. Selection, frailty, and mixture models have been proposed to account for potentially nonignorable missingness by relating the longitudinal outcome to time of dropout. In addition, many longitudinal studies encounter multiple types of missing data or reasons for dropout, such as loss to follow-up, disease progression, treatment modifications and death. When clinically distinct dropout reasons are present, it may be preferable to control for both dropout reason and time to gain additional clinical insights. This may be especially interesting when the dropout reason and dropout times differ by the primary exposure variable. We extend a semi-parametric varying-coefficient method for nonignorable dropout to accommodate dropout reason. We apply our method to untreated HIV-infected subjects recruited to the Acute Infection and Early Disease Research Program HIV cohort and compare longitudinal CD4 + T cell count in injection drug users to nonusers with two dropout reasons: anti-retroviral treatment initiation and loss to follow-up.

Establishing a successful clinical research program.

PubMed

Scoglio, Daniele; Fichera, Alessandro

2014-06-01

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

Biobran/MGN-3, an arabinoxylan rice bran, enhances NK cell activity in geriatric subjects: A randomized, double-blind, placebo-controlled clinical trial.

PubMed

Elsaid, Ahmed F; Shaheen, Magda; Ghoneum, Mamdooh

2018-03-01

Aging is associated with a decline in natural killer (NK) and natural killer T (NKT) cell function that may contribute to increased susceptibility to malignancy and infection. A preliminary investigation was conducted examining the hypothesis that arabinoxylan rice bran (Biobran/MGN-3), a denatured hemicellulose with known immunomodulatory activity, could counteract this decline in NK/NKT cell activity in geriatrics. A total of 12 healthy geriatric subjects of both sexes and over 56 years old, participated in a randomized, double-blind, placebo-controlled clinical trial. A total of six subjects served as control and six subjects ingested Biobran/MGN-3 (500 mg/day) for 30 days. The effect of Biobran/MGN-3 supplementation on NK/NKT cell activity was assessed using the degranulation assay. All study subjects were monitored for the development of any inadvertent side effects. In addition, the pharmacological effects of Biobran/MGN-3 on blood cell components and liver and kidney functions were also assessed. Results demonstrated that Biobran/MGN-3 had no effect on the total percentage of NK cells, however it enhanced the cytotoxic activity of induced NK cell expression of cluster of differentiation 107a, when compared with baseline values and with the placebo group (P<0.05). Furthermore, there were no side effects observed, indicating that Biobran/MGN-3 supplementation was safe at the utilized dosage and for the duration of administration. Various additional beneficial effects were observed, including improved mean corpuscular volume and reduced hepatic aspartate aminotransferase enzyme levels, which suggested improved liver function. It was concluded that Biobran/MGN-3 induces a significant increase in NK activity which may increase resistance to viral infections and cancers in the geriatric population. However, additional clinical trials should be conducted in the future to verify these findings.

Impact of peer teaching on nursing students: perceptions of learning environment, self-efficacy, and knowledge.

PubMed

Brannagan, Kim B; Dellinger, Amy; Thomas, Jan; Mitchell, Denise; Lewis-Trabeaux, Shirleen; Dupre, Susan

2013-11-01

Peer teaching has been shown to enhance student learning and levels of self efficacy. The purpose of the current study was to examine the impact of peer-teaching learning experiences on nursing students in roles of tutee and tutor in a clinical lab environment. This study was conducted over a three-semester period at a South Central University that provides baccalaureate nursing education. Over three semesters, 179 first year nursing students and 51 third year nursing students participated in the study. This mixed methods study, through concurrent use of a quantitative intervention design and qualitative survey data, examined differences during three semesters in perceptions of a clinical lab experience, self-efficacy beliefs, and clinical knowledge for two groups: those who received peer teaching-learning in addition to faculty instruction (intervention group) and those who received faculty instruction only (control group). Additionally, peer teachers' perceptions of the peer teaching learning experience were examined. Results indicated positive response from the peer tutors with no statistically significant differences for knowledge acquisition and self-efficacy beliefs between the tutee intervention and control groups. In contrast to previous research, students receiving peer tutoring in conjunction with faculty instruction were statistically more anxious about performing lab skills with their peer tutor than with their instructors. Additionally, some students found instructors' feedback moderately more helpful than their peers and increased gains in knowledge and responsibility for preparation and practice with instructors than with peer tutors. The findings in this study differ from previous research in that the use of peer tutors did not decrease anxiety in first year students, and no differences were found between the intervention and control groups related to self efficacy or cognitive improvement. These findings may indicate the need to better prepare peer tutors, and research should be conducted using more complex skills. Copyright © 2012 Elsevier Ltd. All rights reserved.

Sensitive Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay

PubMed Central

Grützmann, Robert; Molnar, Bela; Pilarsky, Christian; Habermann, Jens K.; Schlag, Peter M.; Saeger, Hans D.; Miehlke, Stephan; Stolz, Thomas; Model, Fabian; Roblick, Uwe J.; Bruch, Hans-Peter; Koch, Rainer; Liebenberg, Volker; deVos, Theo; Song, Xiaoling; Day, Robert H.; Sledziewski, Andrew Z.; Lofton-Day, Catherine

2008-01-01

Background Colorectal cancer (CRC) is the second leading cause of cancer deaths despite the fact that detection of this cancer in early stages results in over 90% survival rate. Currently less than 45% of at-risk individuals in the US are screened regularly, exposing a need for better screening tests. We performed two case-control studies to validate a blood-based test that identifies methylated DNA in plasma from all stages of CRC. Methodology/Principal Findings Using a PCR assay for analysis of Septin 9 (SEPT9) hypermethylation in DNA extracted from plasma, clinical performance was optimized on 354 samples (252 CRC, 102 controls) and validated in a blinded, independent study of 309 samples (126 CRC, 183 controls). 168 polyps and 411 additional disease controls were also evaluated. Based on the training study SEPT9-based classification detected 120/252 CRCs (48%) and 7/102 controls (7%). In the test study 73/126 CRCs (58%) and 18/183 control samples (10%) were positive for SEPT9 validating the training set results. Inclusion of an additional measurement replicate increased the sensitivity of the assay in the testing set to 72% (90/125 CRCs detected) while maintaining 90% specificity (19/183 for controls). Positive rates for plasmas from the other cancers (11/96) and non-cancerous conditions (41/315) were low. The rate of polyp detection (>1 cm) was ∼20%. Conclusions/Significance Analysis of SEPT9 DNA methylation in plasma represents a straightforward, minimally invasive method to detect all stages of CRC with potential to satisfy unmet needs for increased compliance in the screening population. Further clinical testing is warranted. PMID:19018278

Group-sequential three-arm noninferiority clinical trial designs

PubMed Central

Ochiai, Toshimitsu; Hamasaki, Toshimitsu; Evans, Scott R.; Asakura, Koko; Ohno, Yuko

2016-01-01

We discuss group-sequential three-arm noninferiority clinical trial designs that include active and placebo controls for evaluating both assay sensitivity and noninferiority. We extend two existing approaches, the fixed margin and fraction approaches, into a group-sequential setting with two decision-making frameworks. We investigate the operating characteristics including power, Type I error rate, maximum and expected sample sizes, as design factors vary. In addition, we discuss sample size recalculation and its’ impact on the power and Type I error rate via a simulation study. PMID:26892481

Indicators of suboptimal performance embedded in the Wechsler Memory Scale-Fourth Edition (WMS-IV).

PubMed

Bouman, Zita; Hendriks, Marc P H; Schmand, Ben A; Kessels, Roy P C; Aldenkamp, Albert P

2016-01-01

Recognition and visual working memory tasks from the Wechsler Memory Scale-Fourth Edition (WMS-IV) have previously been documented as useful indicators for suboptimal performance. The present study examined the clinical utility of the Dutch version of the WMS-IV (WMS-IV-NL) for the identification of suboptimal performance using an analogue study design. The patient group consisted of 59 mixed-etiology patients; the experimental malingerers were 50 healthy individuals who were asked to simulate cognitive impairment as a result of a traumatic brain injury; the last group consisted of 50 healthy controls who were instructed to put forth full effort. Experimental malingerers performed significantly lower on all WMS-IV-NL tasks than did the patients and healthy controls. A binary logistic regression analysis was performed on the experimental malingerers and the patients. The first model contained the visual working memory subtests (Spatial Addition and Symbol Span) and the recognition tasks of the following subtests: Logical Memory, Verbal Paired Associates, Designs, Visual Reproduction. The results showed an overall classification rate of 78.4%, and only Spatial Addition explained a significant amount of variation (p < .001). Subsequent logistic regression analysis and receiver operating characteristic (ROC) analysis supported the discriminatory power of the subtest Spatial Addition. A scaled score cutoff of <4 produced 93% specificity and 52% sensitivity for detection of suboptimal performance. The WMS-IV-NL Spatial Addition subtest may provide clinically useful information for the detection of suboptimal performance.

Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus.

PubMed

Gibb, Roger D; McRorie, Johnson W; Russell, Darrell A; Hasselblad, Vic; D'Alessio, David A

2015-12-01

A number of health benefits are associated with intake of soluble, viscous, gel-forming fibers, including reduced serum cholesterol and the attenuation of postprandial glucose excursions. We assess the effects of psyllium, which is a soluble, gel-forming, nonfermented fiber supplement, on glycemic control in patients who were being treated for type 2 diabetes mellitus (T2DM) and in patients who were at risk of developing T2DM. A comprehensive search was performed of available published literature (Scopus scientific database) and clinical records stored by Procter & Gamble with the use of key search terms to identify clinical studies that assessed the glycemic effects of psyllium in nondiabetic, pre-T2DM, and T2DM patients. We identified 35 randomized, controlled, clinical studies that spanned 3 decades and 3 continents. These data were assessed in 8 meta-analyses. In patients with T2DM, multiweek studies (psyllium dosed before meals) showed significant improvement in both the fasting blood glucose (FBG) concentration (-37.0 mg/dL; P < 0.001) and glycated hemoglobin (HbA1c) [-0.97% (-10.6 mmol/mol); P = 0.048]. Glycemic effects were proportional to baseline FBG; no significant glucose lowering was observed in euglycemic subjects, a modest improvement was observed in subjects with pre-T2DM, and the greatest improvement was observed in subjects who were being treated for T2DM. These data indicate that psyllium would be an effective addition to a lifestyle-intervention program. The degree of psyllium's glycemic benefit was commensurate with the loss of glycemic control. Because the greatest effect was seen in patients who were being treated for T2DM, additional studies are needed to determine how best to incorporate psyllium into existing prevention and treatment algorithms with concomitant hypoglycemic medications. © 2015 American Society for Nutrition.

The effect of manipulation plus massage therapy versus massage therapy alone in people with tension-type headache. A randomized controlled clinical trial.

PubMed

Espí-López, Gemma V; Zurriaga-Llorens, Rosario; Monzani, Lucas; Falla, Deborah

2016-10-01

Manipulative techniques have shown promising results for relief of tension-type headache (TTH), however prior studies either lacked a control group, or suffered from poor methodological quality. The aim of this study was to compare the effect of spinal manipulation combined with massage versus massage alone on range of motion of the cervical spine, headache frequency, intensity and disability in patients with TTH. Randomized, single-blinded, controlled clinical trial. University clinic. We enrolled 105 subjects with TTH. Participants were divided into two groups: 1) manipulation and massage; 2) massage only (control). Four treatment sessions were applied over four weeks. The Headache Disability Inventory (HDI) and range of upper cervical and cervical motion were evaluated at baseline, immediately after the intervention and at a follow-up, 8 weeks after completing the intervention. Both groups demonstrated a large (ƒ=1.22) improvement on their HDI scores. Those that received manipulation reported a medium-sized reduction (ƒ=0.33) in headache frequency across all data points (P<0.05) compared to the control group. Both groups showed a large within-subject effect for upper cervical extension (ƒ=0.62), a medium-sized effect for cervical extension (ƒ=0.39), and large effects for upper cervical (ƒ=1.00) and cervical (ƒ=0.27) flexion. The addition of manipulation resulted in larger gains of upper cervical flexion range of motion, and this difference remained stable at the follow-up. These findings support the benefit of treating TTH with either massage or massage combined with a manipulative technique. However, the addition of manipulative technique was more effective for increasing range of motion of the upper cervical spine and for reducing the impact of headache. Although massage provided relief of headache in TTH sufferers, when combined with cervical manipulation, there was a stronger effect on range of upper cervical spine motion.

Cost-effectiveness of a disease management programme for secondary prevention of coronary heart disease and heart failure in primary care.

PubMed

Turner, D A; Paul, S; Stone, M A; Juarez-Garcia, A; Squire, I; Khunti, K

2008-12-01

To determine if a disease management programme for patients with coronary heart disease and heart failure represents an efficient use of health services resources. We carried out an economic evaluation alongside a cluster randomised control trial of 1163 patients with coronary heart disease and chronic heart failure in 20 primary care practices in the United Kingdom. Practices were randomised to either a control group, where patients received standard general practice care, or an intervention group where patients had access to a specialist nurse-led disease management programme. We estimated costs in both groups for coronary heart disease-related resource use. The main outcome measure used in the economic evaluation was quality adjusted life years (QALY) measured using the EuroQol. The disease management programme was associated with an increase in the QALY measured of 0.03 per year and an increase in the total NHS costs of 425 pounds (540 euros), of this only 83 pounds was directly associated with the provision of the nurse clinics. The clinics generated additional QALY at an incremental cost of 13 pounds 158 per QALY compared to the control group. The use of a nurse-led disease management programme is associated with increased costs in other coronary heart disease-related services as well as for the costs of the clinics. They are also associated with improvements in health. Even in the short term these disease management programmes may represent a cost-effective service, as additional QALY are generated at an acceptable extra cost.

Scapular positioning and motor control in children and adults: a laboratory study using clinical measures.

PubMed

Struyf, Filip; Nijs, Jo; Horsten, Stijn; Mottram, Sarah; Truijen, Steven; Meeusen, Romain

2011-04-01

The scapular muscular system is the major determinant of scapular positioning. In addition, strength and muscular endurance develops from childhood through adolescence. It is not known whether differences in scapular positioning and motor control between adults and children may exist. Ninety-two shoulders of 46 adults (mean = 39.4; 18-86 years; SD = 22.5), and 116 shoulders of 59 children (mean = 11.6; 6-17 years; SD = 3.5), were included in the study. Scapular positioning data were collected using a clinical assessment protocol including visual observation of titling and winging, measurement of forward shoulder posture, measurement of scapular upward rotation, and the Kinetic Medial Rotation Test (KMRT). The observation protocol for scapular winging and tilting did not show significant differences between adults and children. After controlling for height, forward shoulder posture (relaxed (0.28 cm/cm (0.06) vs. 0.31 cm/cm (0.07) and retracted (0.15 cm/cm (0.05) vs. 0.20 cm/cm (0.06)) were significantly smaller in children than in adults (P < 0.01). In addition, children showed greater scapular upward rotation (18.6°; SD 9.6°) than adults (14.5°; SD 10.9°) at 90° shoulder abduction. No significant differences were seen between children (19% positive test) and adults (24% positive test) using the KMRT. Children and adults show significant but small differences in scapular upward rotation and forward shoulder posture. These data provide useful reference values using a clinical protocol. Copyright © 2010 Elsevier Ltd. All rights reserved.

To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

PubMed Central

2011-01-01

Background Recently, there has been mounting interest in scaling-up vector control against malaria in Africa. It needs to be determined if indoor residual spraying (IRS with DDT) will provide significant marginal protection against malaria over current best practice of long-lasting insecticidal nets (LLINs) and prompt treatment in a controlled trial, given that DDT is currently the most persistent insecticide for IRS. Methods A 2 armed cluster-randomised controlled trial will be conducted to assess whether DDT IRS and LLINs combined provide better protection against clinical malaria in children than LLINs alone in rural Gambia. Each cluster will be a village, or a group of small adjacent villages; all clusters will receive LLINs and half will receive IRS in addition. Study children, aged 6 months to 13 years, will be enrolled from all clusters and followed for clinical malaria using passive case detection to estimate malaria incidence for 2 malaria transmission seasons in 2010 and 2011. This will be the primary endpoint. Exposure to malaria parasites will be assessed using light and exit traps followed by detection of Anopheles gambiae species and sporozoite infection. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection and the prevalence of anaemia. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN01738840 - Spraying And Nets Towards malaria Elimination (SANTE) PMID:21663656

Clinical effects of Angelica dahurica dressing on patients with I-II phase pressure sores.

PubMed

Gong, Fen; Niu, Junzhi; Pei, Xing

2016-11-02

Angelica dahurica is a well-known traditional Chinese Medicine (TCM), while little information is available about its effects on pressure sores. We aimed to investigate the clinical effect of Angelica dahurica on patients with I-II phase pressure sores, as well as the underlying mechanism. Patients (n = 98) with phase I and phase II pressure sores were enrolled and randomly assigned to control and treated groups. In addition to holistic nursing, patients in the control group received compound clotrimazole cream, while patients in the treated group received continuous 4 weeks of external application of Angelica dahurica dressing. Therapeutic effect was recorded, along with the levels of interleukin-8 (IL-8), epidermal growth factor (EGF), transforming growth factor (TGF)-β, and vascular endothelial growth factor (VEGF). Besides, HaCaT cells were cultured with different concentrations of Angelica dahurica, and then cell viability, clone formation numbers, cell cycle, and levels of cyclin D1 and cyclin-dependent kinase (CDK) 2 were determined. The total effective rate in the treated group was significantly higher than in the control group. Levels of IL-8, EGF, TGF-β, and VEGF were statistically increased by Angelica dahurica. In addition, the cell viability and clone formation numbers were significantly upregulated by Angelica dahurica in a dose-dependent manner. Also, the percentage of cells in G0/G1 phase, and levels of cyclin D1 and CDK2 were significantly elevated. Our results suggest that Angelica dahurica may provide an effective clinical treatment for I-II phase pressure sores.

Caries experience of adults attending private and public dental clinics in Australia.

PubMed

Brennan, David S; Do, Loc Giang; Slade, Gary D

2011-01-01

In Australia, the majority of dental patients attend the private sector, while those with means tested eligibility for government assistance may attend the public sector. The aims of this study were to compare dental caries among persons who last visited private and public clinics, controlling for age, sex, reason for visit, and income. Data were collected in 2004-06, using a three-stage, stratified clustered sample of Australians aged 15+years, involving a computer-assisted telephone interview (CATI), oral examination, and mailed questionnaire. A total of 14,123 adults responded to the CATI (49 percent response) of whom 5,505 (44 percent of those interviewed) had an oral epidemiological examination. Multivariate regression analysis controlling for age, sex, reason for visit, and showed (P < 0.05) that persons attending public clinics had higher levels of decayed (beta = 0.33) and missing teeth (beta = 0.83), but lower levels of filled teeth (beta = -1.09) compared with the reference category of private clinics. Persons who attend for dental care in the public sector have worse oral health than adults who visit private dental clinics, in addition to an independent effect of socioeconomic disadvantage.

Challenges in clinical applications of brain computer interfaces in individuals with spinal cord injury

PubMed Central

Rupp, Rüdiger

2014-01-01

Brain computer interfaces (BCIs) are devices that measure brain activities and translate them into control signals used for a variety of applications. Among them are systems for communication, environmental control, neuroprostheses, exoskeletons, or restorative therapies. Over the last years the technology of BCIs has reached a level of matureness allowing them to be used not only in research experiments supervised by scientists, but also in clinical routine with patients with neurological impairments supervised by clinical personnel or caregivers. However, clinicians and patients face many challenges in the application of BCIs. This particularly applies to high spinal cord injured patients, in whom artificial ventilation, autonomic dysfunctions, neuropathic pain, or the inability to achieve a sufficient level of control during a short-term training may limit the successful use of a BCI. Additionally, spasmolytic medication and the acute stress reaction with associated episodes of depression may have a negative influence on the modulation of brain waves and therefore the ability to concentrate over an extended period of time. Although BCIs seem to be a promising assistive technology for individuals with high spinal cord injury systematic investigations are highly needed to obtain realistic estimates of the percentage of users that for any reason may not be able to operate a BCI in a clinical setting. PMID:25309420

Evidence-based veterinary dermatology: a systematic review of interventions for Malassezia dermatitis in dogs.

PubMed

Negre, Amélie; Bensignor, Emmanuel; Guillot, Jacques

2009-02-01

The aim of this systematic review was to evaluate the efficacy of antifungal treatments for Malassezia dermatitis in dogs and, when possible, to propose recommendation for or against their use. Electronic searches were carried out using PubMed MEDLINE(R), CABDirect and CONSULTANT database. The volumes of Advances in Veterinary Dermatology, the proceedings of ESVD/ECVD and AAVD/ACVD congresses were hand-searched for studies relevant to this review. All articles and book chapters discussing treatment of Malassezia dermatitis were scanned for additional citations. Lastly, a request was sent to the Vetderm Listserv to share recent clinical trials. The analysis evaluated study design, methodology quality, subject enrolment quality, type of interventions and outcome measures. The searches identified 35 articles, and 14 trials that fulfilled the following selection criteria: (i) in vivo clinical trials, (ii) dogs showing clinical lesions of Malassezia dermatitis and (iii) enrolment of at least five dogs. Among these, only eight studies fulfilled the following additional criterion: (iv) prospective in vivo clinical trials reporting clinical and mycological outcome measures. A total number of 14 different treatment protocols included four blinded, randomized and controlled trials (quality of evidence grade A), four controlled studies lacking blinding and/or randomization (grade B), five open uncontrolled trials (grade C) and one descriptive study (grade D). This systematic review allowed us to recommend, with good evidence, the use of only one topical treatment of Malassezia dermatitis (2% miconazole nitrate +2% chlorhexidine, twice a week for 3 weeks) and with fair evidence the use of two systemic treatments with azole derivatives (ketoconazole, 10 mg kg(-1) day(-1) and itraconazole, 5 mg kg(-1) day(-1) for 3 weeks).

[Diagnostic and Therapeutic Approach of Chronic Spontaneous Urticaria: Recommendations in Portugal].

PubMed

Costa, Célia; Gonçalo, Margarida

2016-11-01

Chronic spontaneous urticaria is a complex disorder, of unclear etiology, easily diagnosed although often difficult to treat. It has a significant impact on the patients' quality of life and results in high direct and indirect costs. The diagnosis of chronic spontaneous urticaria is mainly clinical and a limited number of tests is recommended for differential diagnosis and/or for the investigation/exclusion of possible causes. In addition to the complete blood count and C-reactive protein, and/or erythrocyte sedimentation rate, additional tests must be selected according to clinical criteria. The aim of therapy is the complete clinical control of chronic spontaneous urticaria. Evolution should be documented by weekly symptom scoring - Weekly Urticaria Activity Score (UAS7) -, as well as the assessment of quality of life. The therapeutic approach is based on second-generation H1 antihistamines (anti-H1) administered continuously in the approved doses (first line), and, in the absence of a clinical response, up to four times the daily-approved dose (second line). First generation H1 antihistamines are not recommended. Approximately 30% of patients are not controlled with second line therapy, and it is recommended to add a third line therapy. Of the two options, omalizumab and cyclosporine, only omalizumab is approved for chronic spontaneous urticaria and has a better safety profile, thus being preferably recommended. In Portugal there are no national-based recommendations applicable to clinical practice. The elaboration of these recommendations is justified by the need to standardize both the diagnosis and the treatment approach of patients with chronic spontaneous urticaria in Portugal, and for the referral of patients to specialized centers, in the most severe cases.

Evaluation of a Topical Anti-inflammatory/Antifungal Combination Cream in Mild-to-moderate Facial Seborrheic Dermatitis: An Intra-subject Controlled Trial Examining Treated vs. Untreated Skin Utilizing Clinical Features and Erythema-directed Digital Photography.

PubMed

Dall'Oglio, Federica; Tedeschi, Aurora; Guardabasso, Vincenzo; Micali, Giuseppe

2015-09-01

To evaluate if nonprescription topical agents may provide positive outcomes in the management of mild-to-moderate facial seborrheic dermatitis by reducing inflammation and scale production through clinical evaluation and erythema-directed digital photography. Open-label, prospective, not-blinded, intra-patient, controlled, clinical trial (target area). Twenty adult subjects affected by mild-to-moderate facial seborrheic dermatitis were enrolled and instructed to apply the study cream two times daily, initially on a selected target area only for seven days. If the subject developed visible improvement, it was advised to extend the application to all facial affected area for 21 additional days. Efficacy was evaluated by measuring the grade of erythema (by clinical examination and by erythema-directed digital photography), desquamation (by clinical examination), and pruritus (by subject-completed visual analog scale). Additionally, at the end of the protocol, a Physician Global Assessment was carried out. Eighteen subjects completed the study, whereas two subjects were lost to follow-up for nonadherence and personal reasons, respectively. Day 7 data from target areas showed a significant reduction in erythema. At the end of study, a significant improvement was recorded for erythema, desquamation, and pruritus compared to baseline. Physician Global Assessment showed improvement in 89 percent of patients, with a complete response in 56 percent of cases. These preliminary results indicate that the study cream may be a viable nonprescription therapeutic option for patients affected by facial seborrheic dermatitis able to determine early and significant improvement. This study also emphasizes the advantages of using an erythema-directed digital photography system for assisting in a simple, more accurate erythema severity grading and therapeutic monitoring in patients affected by seborrheic dermatitis.

Impact of scribes on patient interaction, productivity, and revenue in a cardiology clinic: a prospective study

PubMed Central

Bank, Alan J; Obetz, Christopher; Konrardy, Ann; Khan, Akbar; Pillai, Kamalesh M; McKinley, Benjamin J; Gage, Ryan M; Turnbull, Mark A; Kenney, William O

2013-01-01

Objective Scribes have been used in the emergency department to improve physician productivity and patient interaction. There are no controlled, prospective studies of scribe use in the clinic setting. Methods A prospective controlled study compared standard visits (20 minute follow-up and 40 minute new patient) to a scribe system (15 minute follow-up and 30 minute new patient) in a cardiology clinic. Physician productivity, patient satisfaction, physician–patient interaction, and revenue were measured. Results Four physicians saw 129 patients using standard care and 210 patients with scribes during 65 clinic hours each. Patients seen per hour increased (P < 0.001) from 2.2 ± 0.3 to 3.5 ± 0.4 (59% increase) and work relative value units (wRVU) per hour increased (P < 0.001) from 3.5 ± 1.3 to 5.5 ± 1.3 (57% increase). Patient satisfaction was high at baseline and unchanged with scribes. In a substudy, direct patient contact time was lower (9.1 ± 2.0 versus 12.9 ± 3.4 minutes; P < 0.01) for scribe visits, but time of patient interaction (without computer) was greater (6.7 ± 2.1 versus 1.5 ± 1.9 minutes; P < 0.01). Subjective assessment of physician–patient interaction (1–10) was higher (P < 0.01) on scribe visits (9.1 ± 0.9 versus 7.9 ± 1.1). Direct and indirect (downstream) revenue per patient seen was $142 and $2,398, with $205,740 additional revenue generated from the 81 additional patients seen with scribes. Conclusion Using scribes in a cardiology clinic is feasible, produces improvements in physician–patient interaction, and results in large increases in physician productivity and system cardiovascular revenue. PMID:23966799

Clinical characterization, genetic mapping and whole-genome sequence analysis of a novel autosomal recessive intellectual disability syndrome.

PubMed

Kaasinen, Eevi; Rahikkala, Elisa; Koivunen, Peppi; Miettinen, Sirpa; Wamelink, Mirjam M C; Aavikko, Mervi; Palin, Kimmo; Myllyharju, Johanna; Moilanen, Jukka S; Pajunen, Leila; Karhu, Auli; Aaltonen, Lauri A

2014-10-01

We identified six patients presenting with a strikingly similar clinical phenotype of profound syndromic intellectual disability of unknown etiology. All patients lived in the same village. Extensive genealogical work revealed that the healthy parents of the patients were all distantly related to a common ancestor from the 17th century, suggesting autosomal recessive inheritance. In addition to intellectual disability, the clinical features included hypotonia, strabismus, difficulty to fix the eyes to an object, planovalgus in the feet, mild contractures in elbow joints, interphalangeal joint hypermobility and coarse facial features that develop gradually during childhood. The clinical phenotype did not fit any known syndrome. Genome-wide SNP genotyping of the patients and genetic mapping revealed the longest shared homozygosity at 3p22.1-3p21.1 encompassing 11.5 Mb, with no other credible candidate loci emerging. Single point parametric linkage analysis showed logarithm of the odds score of 11 for the homozygous region, thus identifying a novel intellectual disability predisposition locus. Whole-genome sequencing of one affected individual pinpointed three genes with potentially protein damaging homozygous sequence changes within the predisposition locus: transketolase (TKT), prolyl 4-hydroxylase transmembrane (P4HTM), and ubiquitin specific peptidase 4 (USP4). The changes were found in heterozygous form with 0.3-0.7% allele frequencies in 402 whole-genome sequenced controls from the north-east of Finland. No homozygotes were found in this nor additional control data sets. Our study facilitates clinical and molecular diagnosis of patients with this novel autosomal recessive intellectual disability syndrome. However, further studies are needed to unambiguously identify the underlying genetic defect. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Platelet-rich plasma use in anterior cruciate ligament surgery: systematic review of the literature.

PubMed

Figueroa, David; Figueroa, Francisco; Calvo, Rafael; Vaisman, Alex; Ahumada, Ximena; Arellano, Sergio

2015-05-01

To systematically review the current literature for evidence that would substantiate the use of platelet-rich plasma (PRP) in the treatment of anterior cruciate ligament (ACL) ruptures. We performed a systematic search in PubMed and Embase of studies written in the English and Spanish languages that compared the use of PRP with a control group in patients with ACL injuries assessing graft-to-bone healing, graft maturation, and/or clinical outcomes and were randomized controlled trials or prospective cohort studies. Eleven studies fulfilled the inclusion criteria, comprising 516 patients (266 ACL reconstructions using PRP and 250 ACL reconstructions without PRP). Six studies reported a statistically significant difference (4 studies) or tendency toward faster graft maturation in the platelet group (2 studies). One study found no differences. Regarding tunnel healing/widening, 1 study showed faster healing in the PRP group and 5 studies showed no differences between the 2 groups. Considering clinical outcomes, 1 study showed better clinical outcomes with PRP use and 5 studies showed no benefits with the use of PRP. Concerning ACL graft maturation, there is promising evidence that the addition of PRP could be a synergic factor in acquiring maturity more quickly than grafts with no PRP, with the clinical implication of this remaining unclear. Regarding tunnel healing, it appears that there is not an improvement with the addition of PRP. There is no proof that clinical outcomes of ACL surgery are enhanced by the use of PRP. Level III, systematic review of Level I through III studies. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

The utilization of a diode laser in the surgical treatment of peri-implantitis. A randomized clinical trial.

PubMed

Papadopoulos, Christos A; Vouros, Ioannis; Menexes, Georgios; Konstantinidis, Antonis

2015-11-01

A comparison of different treatment modalities of peri-implantitis can lead to the development and application of more effective and efficient methods of therapy in clinical practice. This study compares the effectiveness of open flap debridement used alone, with an approach employing the additional use of a diode laser for the treatment of peri-implantitis. Nineteen patients were divided into two groups and treated for peri-implantitis. In the control group (C group), the therapy utilized access flaps, plastic curettes, and sterilized gauzes soaked in saline. The test group (L group) was treated similarly but with additional irradiation using a diode laser. The parameters studied were pocket depth (PD) as the primary outcome variable, clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) as secondary variables. Measurements were performed at three different time points, baseline (BSL), 3 months, and 6 months after treatment. Three months after treatment, a mean PD reduction of 1.19 mm for the control group and 1.38 mm for the laser group was recorded. The corresponding BOP changes were 72.9 and 66.7%, respectively. These changes were significant and remained at the same levels at the 6-month examination (p < 0.05). CAL was reduced significantly only in group L from 5.25 mm at baseline to 4.54 mm at 3 months, remaining at this level at 6 months (p < 0.05). PI was reduced significantly in group C at 3 months from 37.5 to 6.3%. The 6-month data showed no statistically significant difference (p < 0.05) from the 3-month measurements. The two methods of therapy for peri-implantitis examined seemed to be equally efficient in the reduction of the PD and BOP 3 months after surgery, with the results sustained at the same levels after 6 months. CAL significantly improved only in the test group after 3 months. PI was reduced and maintained at low levels in both groups. Surgical treatment of peri-implantitis by access flaps leads to improvement of all clinical parameters studied while the additional use of diode laser does not seem to have an extra beneficiary effect. The additional use of a diode laser in the surgical treatment of peri-implantitis offers a limited clinical benefit.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

PubMed

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

Efficacy of adding the Kinesio Taping method to guideline-endorsed conventional physiotherapy in patients with chronic nonspecific low back pain: a randomised controlled trial.

PubMed

Added, Marco Aurélio Nemitalla; Costa, Leonardo Oliveira Pena; Fukuda, Thiago Yukio; de Freitas, Diego Galace; Salomão, Evelyn Cassia; Monteiro, Renan Lima; Costa, Lucíola da Cunha Menezes

2013-10-24

Chronic nonspecific low back pain is a significant health condition with high prevalence worldwide and it is associated with enormous costs to society. Clinical practice guidelines show that many interventions are available to treat patients with chronic low back pain, but the vast majority of these interventions have a modest effect in reducing pain and disability. An intervention that has been widespread in recent years is the use of elastic bandages called Kinesio Taping. Although Kinesio Taping has been used extensively in clinical practice, current evidence does not support the use of this intervention; however these conclusions are based on a small number of underpowered studies. Therefore, questions remain about the effectiveness of the Kinesio Taping method as an additional treatment to interventions, such as conventional physiotherapy, that have already been recommended by the current clinical practice guidelines in robust and high-quality randomised controlled trials. We aim to determine the effectiveness of the addition of the use of Kinesio Taping in patients with chronic nonspecific low back pain who receive guideline-endorsed conventional physiotherapy. One hundred and forty-eight patients will be randomly allocated to receive either conventional physiotherapy, which consists of a combination of manual therapy techniques, general exercises, and specific stabilisation exercises (Guideline-Endorsed Conventional Physiotherapy Group) or to receive conventional physiotherapy with the addition of Kinesio Taping to the lumbar spine (Conventional Physiotherapy plus Kinesio Taping Group) over a period of 5 weeks (10 sessions of treatment). Clinical outcomes (pain intensity, disability and global perceived effect) will be collected at baseline and at 5 weeks, 3 months, and 6 months after randomisation. We will also collect satisfaction with care and adverse effects after treatment. Data will be collected by a blinded assessor. All statistical analysis will be conducted following the principles of intention to treat, and the effects of treatment will be calculated using Linear Mixed Models. The results of this study will provide new information about the usefulness of Kinesio Taping as an additional component of a guideline-endorsed physiotherapy program in patients with chronic nonspecific low back pain.

Mucosal immunity in HIV controllers: the right place at the right time.

PubMed

Shacklett, Barbara L; Ferre, April L

2011-05-01

The phenomenon of long-term nonprogression in HIV infection has been recognized for some time, and the ability of rare individuals, designated 'elite controllers', to control HIV in the absence of therapy is the focus of numerous ongoing studies. This review focuses on studies of HIV-specific immune responses in mucosal tissues as a potential correlate of immune control, with an emphasis on recently published work. Genetic studies have implicated a role for elements localized to the major histocompatibility complex (MHC) on chromosome 6 in the immune control of HIV infection. In parallel, functional studies have strongly implicated MHC class I-restricted, CD8+ T-cell responses as a major contributor to elite control. In addition, the localization of HIV-specific CD8+ and CD4+ T cells with respect to the major sites of virus replication in the body may be critical in determining clinical outcome. Recent findings suggest that MHC class I-restricted, CD8+ T cells are a major component of immune control in 'elite controllers'. In addition, the presence of these effector cells at or near critical viral reservoirs, such as mucosal tissues, may be critical in determining their effectiveness at limiting viral replication and dissemination.

Development of a Clinical Framework for Mirror Therapy in Patients with Phantom Limb Pain: An Evidence-based Practice Approach.

PubMed

Rothgangel, Andreas; Braun, Susy; de Witte, Luc; Beurskens, Anna; Smeets, Rob

2016-04-01

To describe the development and content of a clinical framework for mirror therapy (MT) in patients with phantom limb pain (PLP) following amputation. Based on an a priori formulated theoretical model, 3 sources of data collection were used to develop the clinical framework. First, a review of the literature took place on important clinical aspects and the evidence on the effectiveness of MT in patients with phantom limb pain. In addition, questionnaires and semi-structured interviews were used to analyze clinical experiences and preferences of physical and occupational therapists and patients suffering from PLP regarding the application of MT. All data were finally clustered into main and subcategories and were used to complement and refine the theoretical model. For every main category of the a priori formulated theoretical model, several subcategories emerged from the literature search, patient, and therapist interviews. Based on these categories, we developed a clinical flowchart that incorporates the main and subcategories in a logical way according to the phases in methodical intervention defined by the Royal Dutch Society for Physical Therapy. In addition, we developed a comprehensive booklet that illustrates the individual steps of the clinical flowchart. In this study, a structured clinical framework for the application of MT in patients with PLP was developed. This framework is currently being tested for its effectiveness in a multicenter randomized controlled trial. © 2015 World Institute of Pain.

Rituximab associated neutropenia: Description of three cases and an insight into the underlying pathogenesis

PubMed Central

Weissmann-Brenner, Alina; Brenner, Baruch; Belyaeva, Inessa; Lahav, Meir; Rabizadeh, Esther

2011-01-01

Summary Background To describe Rituximab associated neutropenia (RAN), and to explore its underlying mechanism. Case Report We describe three patients with RAN. The effect of patient’s plasma on colony forming unit, Granulocyte-Monocyte (CFU-GM) was measured by the addition of plasma to the culture of a healthy bone-marrow. Repeated tests were performed after recovery of white count. In the leukopenic period the patient’s plasma inhibited CFU growth completely. Control plasma did not have such an effect. Addition of patient’s cell supernatant to bone marrow cells did not change the number of CFU. The same effect was demonstrated in normal control. After recovery the patient’s plasma did not inhibit colony formation, similar to control. Conclusions RAN is a clinically significant side effect. It may take place during treatment or several months afterwards. Circulating antibodies in the plasma may be responsible for this unique BM toxicity. PMID:22037749

Feasibility trial of a Spanish-language multimedia educational intervention.

PubMed

Wells, Kristen J; McIntyre, Jessica; Gonzalez, Luis E; Lee, Ji-Hyun; Fisher, Kate J; Jacobsen, Paul B; Meade, Cathy; Muñoz-Antonia, Teresita; Quinn, Gwendolyn P

2013-10-01

Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results may not generalize to other Hispanic populations. In the pilot project, we demonstrated the feasibility of delivering multimedia information to patients in medical oncology clinics. Because delivery in a clinical setting was found to be feasible, a larger study should be conducted to evaluate the efficacy of the multimedia intervention with respect to promoting accrual of Hispanic patients to clinical trials.

Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system.

PubMed

Royle, P; Waugh, N

2003-01-01

To contribute to making searching for Technology Assessment Reports (TARs) more cost-effective by suggesting an optimum literature retrieval strategy. A sample of 20 recent TARs. All sources used to search for clinical and cost-effectiveness studies were recorded. In addition, all studies that were included in the clinical and cost-effectiveness sections of the TARs were identified, and their characteristics recorded, including author, journal, year, study design, study size and quality score. Each was also classified by publication type, and then checked to see whether it was indexed in the following databases: MEDLINE, EMBASE, and then either the Cochrane Controlled Trials Register (CCTR) for clinical effectiveness studies or the NHS Economic Evaluation Database (NHS EED) for the cost-effectiveness studies. Any study not found in at least one of these databases was checked to see whether it was indexed in the Science Citation Index (SCI) and BIOSIS, and the American Society of Clinical Oncology (ASCO) Online if a cancer review. Any studies still not found were checked to see whether they were in a number of additional databases. The median number of sources searched per TAR was 20, and the range was from 13 to 33 sources. Six sources (CCTR, DARE, EMBASE, MEDLINE, NHS EED and sponsor/industry submissions to National Institute for Clinical Excellence) were used in all reviews. After searching the MEDLINE, EMBASE and NHS EED databases, 87.3% of the clinical effectiveness studies and 94.8% of the cost-effectiveness studies were found, rising to 98.2% when SCI, BIOSIS and ASCO Online and 97.9% when SCI and ASCO Online, respectively, were added. The median number of sources searched for the 14 TARs that included an economic model was 9.0 per TAR. A sensitive search filter for identifying non-randomised controlled trials (RCT), constructed for MEDLINE and using the search terms from the bibliographic records in the included studies, retrieved only 85% of the known sample. Therefore, it is recommended that when searching for non-RCT studies a search is done for the intervention alone, and records are then scanned manually for those that look relevant. Searching additional databases beyond the Cochrane Library (which includes CCTR, NHS EED and the HTA database), MEDLINE, EMBASE and SCI, plus BIOSIS limited to meeting abstracts only, was seldom found to be effective in retrieving additional studies for inclusion in the clinical and cost-effectiveness sections of TARs (apart from reviews of cancer therapies, where a search of the ASCO database is recommended). A more selective approach to database searching would suffice in most cases and would save resources, thereby making the TAR process more efficient. However, searching non-database sources (including submissions from manufacturers, recent meeting abstracts, contact with experts and checking reference lists) does appear to be a productive way of identifying further studies.

The role of clinical toxicologists and poison control centers in public health.

PubMed

Sutter, Mark E; Bronstein, Alvin C; Heard, Stuart E; Barthold, Claudia L; Lando, James; Lewis, Lauren S; Schier, Joshua G

2010-06-01

Poison control centers and clinical toxicologists serve many roles within public health; however, the degree to which these entities collaborate is unknown. The objective of this survey was to identify successful collaborations of public health agencies with clinical toxicologists and poison control centers. Four areas including outbreak identification, syndromic surveillance, terrorism preparedness, and daily public health responsibilities amenable to poison control center resources were assessed. An online survey was sent to the directors of poison control centers, state epidemiologists, and the most senior public health official in each state and selected major metropolitan areas. This survey focused on three areas: service, structure within the local or state public health system, and remuneration. Questions regarding remuneration and poison control center location within the public health structure were asked to assess if these were critical factors of successful collaborations. Senior state and local public health officials were excluded because of a low response rate. The survey was completed in October 2007. A total of 111 respondents, 61 poison control centers and 50 state epidemiologists, were eligible for the survey. Sixty-nine (62%) of the 111 respondents, completed and returned the survey. Thirty-three (54%) of the 61 poison control centers responded, and 36 of the 50 state epidemiologists (72%) responded. The most frequent collaborations were terrorism preparedness and epidemic illness reporting. Additional collaborations also exist. Important collaborations exist outside of remuneration or poison control centers being a formal part of the public health structure. Poison control centers have expanded their efforts to include outbreak identification, syndromic surveillance, terrorism preparedness, and daily public health responsibilities amenable to poison control center resources. Collaboration in these areas and others should be expanded. Published by Elsevier Inc.

Cost-effectiveness of achieving clinical improvement with a dissonance-based eating disorder prevention program.

PubMed

Akers, Laura; Rohde, Paul; Stice, Eric; Butryn, Meghan L; Shaw, Heather

2017-01-01

Using data from an effectiveness trial delivered by college clinicians, we examined the cost-effectiveness of the dissonance-based Body Project program for reducing eating disorder symptoms in women with body dissatisfaction. The outcome of interest was individual-level change; 14.9% of Body Project participants attained clinically meaningful improvement vs. 6.7% of controls. Delivering the intervention costs approximately $70 (2012 U.S. dollars) per person. Incremental cost-effectiveness was $838 for each additional at-risk person reducing eating disorder symptomology to a clinically meaningful degree. These analyses demonstrate the economic value of the Body Project for college-age women with symptoms below the eating disorder diagnosis threshold.

Randomized controlled trial of a cognitive-behavioral intervention for HIV-positive persons: an investigation of treatment effects on psychosocial adjustment.

PubMed

Carrico, Adam W; Chesney, Margaret A; Johnson, Mallory O; Morin, Stephen F; Neilands, Torsten B; Remien, Robert H; Rotheram-Borus, Mary Jane; Lennie Wong, F

2009-06-01

Questions remain regarding the clinical utility of psychological interventions for HIV-positive persons because randomized controlled trials have utilized stringent inclusion criteria and focused extensively on gay men. The present randomized controlled trial examined the efficacy of a 15-session, individually delivered cognitive-behavioral intervention (n = 467) compared to a wait-list control (n = 469) in a diverse sample of HIV-positive persons who reported HIV transmission risk behavior. Five intervention sessions that dealt with executing effective coping responses were delivered between baseline and the 5 months post-randomization. Additional assessments were completed through 25 months post-randomization. Despite previously documented reductions in HIV transmission risk, no intervention-related changes in psychosocial adjustment were observed across the 25-month investigation period. In addition, there were no intervention effects on psychosocial adjustment among individuals who presented with mild to moderate depressive symptoms. More intensive mental health interventions may be necessary to improve psychosocial adjustment among HIV-positive individuals.

Intimate Partner and General Aggression Perpetration among Combat Veterans Presenting to a Posttraumatic Stress Disorder Clinic

PubMed Central

Taft, Casey T.; Weatherill, Robin P.; Woodward, Halley E.; Pinto, Lavinia A.; Watkins, Laura E.; Miller, Mark W.; Dekel, Rachel

2013-01-01

This study examined rates and correlates of intimate partner and general aggression perpetration among 236 male combat veterans seeking services in a VA PTSD clinic. Approximately 33% of those in an intimate relationship reported perpetrating partner physical aggression in the previous year, and 91% reported partner psychological aggression. Comparable rates were found for general aggression perpetration among partnered and non-partnered veterans. PTSD symptoms as well as symptoms of depression were associated with aggression across subgroups and forms of aggression, and PTSD symptoms reflecting arousal and lack of control were generally the strongest predictor of aggression. Findings indicate a need for additional aggression screening and intervention development for this population, and highlight the targeting of heightened arousal and lack of behavioral control in aggression interventions. PMID:20099937

Dyke-Davidoff-Masson Syndrome. An unusual cause of status epilepticus.

PubMed

Zawar, Ifrah; Khan, Ashfa A; Sultan, Tipu; Rathore, Ahsan W

2015-10-01

The Dyke-Davidoff-Masson Syndrome (DDMS) results from an insult to the growing brain in utero or early infancy, which lead to loss of neurons compromising the growth of the brain. Clinical presentation includes seizures, hemiparesis, facial asymmetry, and learning disability. Radiological findings include cerebral atrophy on one side. Here, we present a case with status epilepticus who had underlying DDMS. It is a rare syndrome and uncommon cause for status epilepticus. Infections of CNS, hypoxic ischemic encephalopathy, intracranial bleed, trauma, congenital vascular malformations are the common causes of this syndrome. Diagnosis is established after clinical history, examination, and MRI. Intractable seizures can be controlled with appropriate anticonvulsants. Subsequently, these children may require physiotherapy, speech therapy, and occupational therapy in addition to the anticonvulsant medication. Outcome is better if the seizures are controlled.

Evaluating a health care provider delivered intervention to reduce intimate partner violence and mitigate associated health risks: study protocol for a randomized controlled trial in Mexico City.

PubMed

Falb, Kathryn L; Diaz-Olavarrieta, Claudia; Campos, Paola A; Valades, Jimena; Cardenas, Roosebelinda; Carino, Giselle; Gupta, Jhumka

2014-07-30

Intimate partner violence (IPV) victimization is a prevalent issue among women residing in Mexico City. Comprehensive and integrated health care provider (HCP) delivered programs in clinic-settings are needed, yet few have been evaluated in Latin America, including Mexico. In addition, there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics. The current randomized controlled trial seeks to increase midlevel HCPs' capacity, specifically nurses, who are often the first point of contact in this setting, to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation. Specific outcomes include changes in past-year IPV (physical and/or sexual), reproductive coercion, safety planning, use of community resources, and quality of life. Forty-two public health clinics in Mexico City were randomized to treatment or control clinics. Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV, providing supportive referrals, and assessing for health and safety risks. Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women. Women were screened for eligibility (currently experiencing abuse in a heterosexual relationship, 18-44 years of age, non-pregnant or in first trimester) by research assistants in private areas of waiting rooms in health clinics. Consenting women completed a baseline survey and received the study protocol for that clinic. In treatment clinics, women received the nurse delivered session at baseline and received a follow-up counseling session after three months. Surveys are conducted at baseline, three months, and fifteen months from baseline. This study will provide important insight into whether a nurse-delivered program can assist women currently experiencing abuse in a Latin American context. Findings can be used to inform IPV programs and policies in Mexico City's public health clinics. NCT01661504.

Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial.

PubMed

González-Ortega, Itxaso; Echeburúa, Enrique; García-Alocén, Adriana; Vega, Patricia; González-Pinto, Ana

2016-07-29

The high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation). This is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group. This study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder. NCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014.

The application of disease management to clinical trial designs.

PubMed

Puterman, Jared; Alter, David A

2009-08-01

The utilization of disease management (DM) as a minimum standard of care is believed to facilitate pronounced benefits in overall patient outcome and cost management. Randomized clinical trials remain the gold standard evaluative tool in clinical medicine. However, the extent to which contemporary cardiovascular clinical trials incorporate DM components into their treatment or control arms is unknown. Our study is the first to evaluate the extent to which clinical trials incorporate DM as a minimum standard of care for both the intervention and control groups. In total, 386 clinical trials published in 3 leading medical journals between 2003 and 2006 were evaluated. For each study, elements related to DM care, as defined using the American Heart Association Taxonomy, were abstracted and characterized. Our results demonstrate that while the application of DM has increased over time, only 3.4% of the clinical trials examined incorporated all 8 DM elements (and only 11% of such trials incorporated 4 DM elements). A significant association was found between study year and the inclusion of more than 3 elements of DM (chi(2) = 10.10 (3); p = 0.018). In addition, associations were found between study objective and DM criteria, as well as between cohort type and domains described. Our study serves as a baseline reference for the tracking of DM within, and its application to, randomized clinical trials. Moreover, our results underscore the need for broader implementation and evaluation of DM as a minimum care standard within clinical trial research.

Anorexia nervosa and its relation to depression, anxiety, alexithymia and emotional processing deficits.

PubMed

Lulé, Dorothée; Schulze, Ulrike M E; Bauer, Kathrin; Schöll, Friederike; Müller, Sabine; Fladung, Anne-Katharina; Uttner, Ingo

2014-06-01

Psychopathological changes and dysfunction in emotion processing have been described for anorexia nervosa (AN). Yet, findings are applicable to adult patients only. Furthermore, potential for discriminative power in clinical practice in relation to clinical parameters has to be discussed. The aim of this study was to investigate psychopathology and emotional face processing in adolescent female patients with AN. In a sample of 15 adolescent female patients with AN (16.2 years, SD ± 1.26) and 15 age and sex matched controls we assessed alexithymia, depression, anxiety and empathy in addition to emotion labelling and social information processing. AN patients had significantly higher alexithymia, higher levels of depression, and state and trait anxiety compared to controls. There was a trend for a lower ability to recognize disgust. Happiness as a positive emotion was recognized better. All facial expressions were recognized significantly faster by AN patients. Associations of pathological eating behaviour and trait anxiety were seen. In accordance with the stress reduction hypothesis, typical psychopathology of alexithymia, anxiety and depression is prevalent in female adolescent AN patients. It is present detached from physical stability. Pathogenesis of AN is multifactorial and already fully present in adolescence. An additional reinforcement process can be discussed. For clinical practice, those parameters might have a better potential for early prognostic factors related to AN than physical parameters and possible implication for intervention is given.

Recurrent duplications of the annexin A1 gene (ANXA1) in autism spectrum disorders.

PubMed

Correia, Catarina T; Conceição, Inês C; Oliveira, Bárbara; Coelho, Joana; Sousa, Inês; Sequeira, Ana F; Almeida, Joana; Café, Cátia; Duque, Frederico; Mouga, Susana; Roberts, Wendy; Gao, Kun; Lowe, Jennifer K; Thiruvahindrapuram, Bhooma; Walker, Susan; Marshall, Christian R; Pinto, Dalila; Nurnberger, John I; Scherer, Stephen W; Geschwind, Daniel H; Oliveira, Guiomar; Vicente, Astrid M

2014-04-10

Validating the potential pathogenicity of copy number variants (CNVs) identified in genome-wide studies of autism spectrum disorders (ASD) requires detailed assessment of case/control frequencies, inheritance patterns, clinical correlations, and functional impact. Here, we characterize a small recurrent duplication in the annexin A1 (ANXA1) gene, identified by the Autism Genome Project (AGP) study. From the AGP CNV genomic screen in 2,147 ASD individuals, we selected for characterization an ANXA1 gene duplication that was absent in 4,964 population-based controls. We further screened the duplication in a follow-up sample including 1,496 patients and 410 controls, and evaluated clinical correlations and family segregation. Sequencing of exonic/downstream ANXA1 regions was performed in 490 ASD patients for identification of additional variants. The ANXA1 duplication, overlapping the last four exons and 3'UTR region, had an overall prevalence of 11/3,643 (0.30%) in unrelated ASD patients but was not identified in 5,374 controls. Duplication carriers presented no distinctive clinical phenotype. Family analysis showed neuropsychiatric deficits and ASD traits in multiple relatives carrying the duplication, suggestive of a complex genetic inheritance. Sequencing of exonic regions and the 3'UTR identified 11 novel changes, but no obvious variants with clinical significance. We provide multilevel evidence for a role of ANXA1 in ASD etiology. Given its important role as mediator of glucocorticoid function in a wide variety of brain processes, including neuroprotection, apoptosis, and control of the neuroendocrine system, the results add ANXA1 to the growing list of rare candidate genetic etiological factors for ASD.

Impact of Inclusion of Industry Trial Results Registries as an Information Source for Systematic Reviews

PubMed Central

Potthast, Regine; Vervölgyi, Volker; McGauran, Natalie; Kerekes, Michaela F.; Wieseler, Beate; Kaiser, Thomas

2014-01-01

Background Clinical trial results registries may contain relevant unpublished information. Our main aim was to investigate the potential impact of the inclusion of reports from industry results registries on systematic reviews (SRs). Methods We identified a sample of 150 eligible SRs in PubMed via backward selection. Eligible SRs investigated randomized controlled trials of drugs and included at least 2 bibliographic databases (original search date: 11/2009). We checked whether results registries of manufacturers and/or industry associations had also been searched. If not, we searched these registries for additional trials not considered in the SRs, as well as for additional data on trials already considered. We reanalysed the primary outcome and harm outcomes reported in the SRs and determined whether results had changed. A “change” was defined as either a new relevant result or a change in the statistical significance of an existing result. We performed a search update in 8/2013 and identified a sample of 20 eligible SRs to determine whether mandatory results registration from 9/2008 onwards in the public trial and results registry ClinicalTrials.gov had led to its inclusion as a standard information source in SRs, and whether the inclusion rate of industry results registries had changed. Results 133 of the 150 SRs (89%) in the original analysis did not search industry results registries. For 23 (17%) of these SRs we found 25 additional trials and additional data on 31 trials already included in the SRs. This additional information was found for more than twice as many SRs of drugs approved from 2000 as approved beforehand. The inclusion of the additional trials and data yielded changes in existing results or the addition of new results for 6 of the 23 SRs. Of the 20 SRs retrieved in the search update, 8 considered ClinicalTrials.gov or a meta-registry linking to ClinicalTrials.gov, and 1 considered an industry results registry. Conclusion The inclusion of industry and public results registries as an information source in SRs is still insufficient and may result in publication and outcome reporting bias. In addition to an essential search in ClinicalTrials.gov, authors of SRs should consider searching industry results registries. PMID:24743113

An Analysis of EMG Electrode Configuration for Targeted Muscle Reinnervation Based Neural Machine Interface

PubMed Central

Huang, He; Zhou, Ping; Li, Guanglin; Kuiken, Todd A.

2015-01-01

Targeted muscle reinnervation (TMR) is a novel neural machine interface for improved myoelectric prosthesis control. Previous high-density (HD) surface electromyography (EMG) studies have indicated that tremendous neural control information can be extracted from the reinnervated muscles by EMG pattern recognition (PR). However, using a large number of EMG electrodes hinders clinical application of the TMR technique. This study investigated a reduced number of electrodes and the placement required to extract sufficient neural control information for accurate identification of user movement intents. An electrode selection algorithm was applied to the HD EMG recordings from each of 4 TMR amputee subjects. The results show that when using only 12 selected bipolar electrodes the average accuracy over subjects for classifying 16 movement intents was 93.0(±3.3)%, just 1.2% lower than when using the entire HD electrode complement. The locations of selected electrodes were consistent with the anatomical reinnervation sites. Additionally, a practical protocol for clinical electrode placement was developed, which does not rely on complex HD EMG experiment and analysis while maintaining a classification accuracy of 88.7±4.5%. These outcomes provide important guidelines for practical electrode placement that can promote future clinical application of TMR and EMG PR in the control of multifunctional prostheses. PMID:18303804

Serum 25-Hydroxy Vitamin D Levels in Turkish Adolescent Girls with Polycystic Ovary Syndrome and the Correlation with Clinical/Biochemical Parameters.

PubMed

Bostanci, Esra Isci; Ozler, Sibel; Yilmaz, Nafiye Karakas; Yesilyurt, Huseyin

2018-06-01

Polycystic ovary syndrome (PCOS) is a common endocrinopathy among female adolescents and young women. The aim of this study was to investigate the relationship between serum 25-hydroxy vitamin D (25[OH] D) levels and metabolic parameters and other characteristics of PCOS and non-PCOS adolescents. Case-control study. We analyzed 31 girls with PCOS as defined using the Rotterdam criteria and 35 girls were non-PCOS control participants. The serum 25(OH) D level was measured. Anthropometric, clinical, endocrine, and metabolic components were determined in both groups. The group with PCOS showed no difference in the level of serum 25(OH) D (14.58 ± 6.15 vs 16.02 ± 7.87; P = .414). In addition to this, no significant correlations were found between serum 25(OH) D levels and endocrine or metabolic parameters in either PCOS patients or control participants. There was no difference in the level of serum 25(OH) D between PCOS patients and matched control participants. Vitamin D deficiency was common among the patients as well as in the control participants. Also, we did not find any relationship between serum 25(OH) D levels and clinical or metabolic profiles in the 2 groups. Copyright © 2017 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

The art of matching brain tissue from patients and controls for postmortem research.

PubMed

Bao, Ai-Min; Swaab, Dick F

2018-01-01

The quality of postmortem research depends strongly on a thorough clinical investigation and documentation of the patient's disorder and therapies. In addition, a systematic and professional neuropathologic investigation of both cases and controls is absolutely crucial. In the experience of the Netherlands Brain Bank (NBB), about 20% of clinical neurologic diagnoses, despite being made in first-rate clinics, have to be revised or require an extra diagnosis after a complete and thorough review by the NBB. The neuropathology examination may reveal for instance that the "controls" already have preclinical neurodegenerative alterations. In postmortem studies the patient and control groups must be matched for as many of the known confounding factors as possible. This is necessary to make the groups as similar as possible, except for the topic being investigated. Confounding factors are present before, during, and after death. They are respectively: (1) genetic background, systemic diseases, duration and gravity of illness, medicines and addictive compounds used, age, sex, gender identity, sexual orientation, circadian and seasonal fluctuations, lateralization; (2) agonal state, stress of dying; and (3) postmortem delay, freezing procedures, fixation and storage time. Consequently, a brain bank should have a large number of controls at its disposal for appropriate matching. If matching fails for some confounders, then their influence may be determined by statistical methods such as analysis of variance or regression models. Copyright © 2018 Elsevier B.V. All rights reserved.

Clinical Efficacy and Safety of Bevacizumab Monotherapy in Patients with Metastatic Melanoma: Predictive Importance of Induced Early Hypertension

PubMed Central

Schuster, Cornelia; Eikesdal, Hans P.; Puntervoll, Hanne; Geisler, Jürgen; Geisler, Stephanie; Heinrich, Daniel; Molven, Anders; Lønning, Per E.; Akslen, Lars A.; Straume, Oddbjørn

2012-01-01

Background VEGF driven angiogenesis plays a key role in cancer progression. We determined the clinical efficacy of bevacizumab monotherapy in patients with metastatic melanoma. Methods and Findings Thirty-five patients with metastatic melanoma in progression were enrolled in this phase II, single arm clinical trial. Each patient received bevacizumab monotherapy 10 mg/kg q14 d until intolerable toxicity or disease progression occurred. Clinical efficacy was evaluated as objective response, disease control (DC), and survival. We observed one complete (3%) and 5 partial (14%) responses. In addition, 5 patients experienced stable disease >6 months (14%) while 24 patients had progressive disease (PD, 69%), corresponding to a total DC at 6 months in 11 out of 35 patients (31%). Median progression free survival (PFS) was 2.14 months and median overall survival (OS) was 9 months (1.12–49). Seven of the 11 patients experiencing DC developed early hypertension (<2 months) compared to 3/24 of patients with PD (P = 0.001), and hypertension was associated with PFS (P = 0.005) and OS (P = 0.013). Conclusion Bevacizumab monotherapy demonstrated promising clinical efficacy in patients with metastatic melanoma with disease control in 31% of the patients. Induced early hypertension was a marker for clinical efficacy of bevacizumab. Trial Registration ClinicalTrials.gov NCT00139360. PMID:22719881

Facilitating large-scale clinical trials: in Asia.

PubMed

Choi, Han Yong; Ko, Jae-Wook

2010-01-01

The number of clinical trials conducted in Asian countries has started to increase as a result of expansion of the pharmaceutical market in this area. There is a growing opportunity for large-scale clinical trials because of the large number of patients, significant market potential, good quality of data, and the cost effective and qualified medical infrastructure. However, for carrying out large-scale clinical trials in Asia, there are several major challenges, including the quality control of data, budget control, laboratory validation, monitoring capacity, authorship, staff training, and nonstandard treatment that need to be considered. There are also several difficulties in collaborating on international trials in Asia because Asia is an extremely diverse continent. The major challenges are language differences, diversity of patterns of disease, and current treatments, a large gap in the experience with performing multinational trials, and regulatory differences among the Asian countries. In addition, there are also differences in the understanding of global clinical trials, medical facilities, indemnity assurance, and culture, including food and religion. To make regional and local data provide evidence for efficacy through the standardization of these differences, unlimited effort is required. At this time, there are no large clinical trials led by urologists in Asia, but it is anticipated that the role of urologists in clinical trials will continue to increase. Copyright © 2010 Elsevier Inc. All rights reserved.

Primary Repair of Moderate Severity Rhegmatogenous Retinal Detachment: A Critical Decision-Making Algorithm.

PubMed

Velez-Montoya, Raul; Jacobo-Oceguera, Paola; Flores-Preciado, Javier; Dalma-Weiszhausz, Jose; Guerrero-Naranjo, Jose; Salcedo-Villanueva, Guillermo; Garcia-Aguirre, Gerardo; Fromow-Guerra, Jans; Morales-Canton, Virgilio

2016-01-01

We reviewed all the available data regarding the current management of non-complex rhegmatogenous retinal detachment and aimed to propose a new decision-making algorithm aimed to improve the single surgery success rate for mid-severity rhegmatogenous retinal detachment. An online review of the Pubmed database was performed. We searched for all available manuscripts about the anatomical and functional outcomes after the surgical management, by either scleral buckle or primary pars plana vitrectomy, of retinal detachment. The search was limited to articles published from January 1995 to December 2015. All articles obtained from the search were carefully screened and their references were manually reviewed for additional relevant data. Our search specifically focused on preoperative clinical data that were associated with the surgical outcomes. After categorizing the available data according to their level of evidence, with randomized-controlled clinical trials as the highest possible level of evidence, followed by retrospective studies, and retrospective case series as the lowest level of evidence, we proceeded to design a logical decision-making algorithm, enhanced by our experiences as retinal surgeons. A total of 7 randomized-controlled clinical trials, 19 retrospective studies, and 9 case series were considered. Additional articles were also included in order to support the observations further. Rhegmatogenous retinal detachment is a potentially blinding disorder. Its surgical management seems to depend more on a surgeon´s preference than solid scientific data or is based on a good clinical history and examination. The algorithms proposed herein strive to offer a more rational approach to improve both anatomical and functional outcomes after the first surgery.

Primary Repair of Moderate Severity Rhegmatogenous Retinal Detachment: A Critical Decision-Making Algorithm

PubMed Central

VELEZ-MONTOYA, Raul; JACOBO-OCEGUERA, Paola; FLORES-PRECIADO, Javier; DALMA-WEISZHAUSZ, Jose; GUERRERO-NARANJO, Jose; SALCEDO-VILLANUEVA, Guillermo; GARCIA-AGUIRRE, Gerardo; FROMOW-GUERRA, Jans; MORALES-CANTON, Virgilio

2016-01-01

We reviewed all the available data regarding the current management of non-complex rhegmatogenous retinal detachment and aimed to propose a new decision-making algorithm aimed to improve the single surgery success rate for mid-severity rhegmatogenous retinal detachment. An online review of the Pubmed database was performed. We searched for all available manuscripts about the anatomical and functional outcomes after the surgical management, by either scleral buckle or primary pars plana vitrectomy, of retinal detachment. The search was limited to articles published from January 1995 to December 2015. All articles obtained from the search were carefully screened and their references were manually reviewed for additional relevant data. Our search specifically focused on preoperative clinical data that were associated with the surgical outcomes. After categorizing the available data according to their level of evidence, with randomized-controlled clinical trials as the highest possible level of evidence, followed by retrospective studies, and retrospective case series as the lowest level of evidence, we proceeded to design a logical decision-making algorithm, enhanced by our experiences as retinal surgeons. A total of 7 randomized-controlled clinical trials, 19 retrospective studies, and 9 case series were considered. Additional articles were also included in order to support the observations further. Rhegmatogenous retinal detachment is a potentially blinding disorder. Its surgical management seems to depend more on a surgeon´s preference than solid scientific data or is based on a good clinical history and examination. The algorithms proposed herein strive to offer a more rational approach to improve both anatomical and functional outcomes after the first surgery. PMID:28289689

Quantifying Heterogeneous Malaria Exposure and Clinical Protection in a Cohort of Ugandan Children

PubMed Central

Rodriguez-Barraquer, Isabel; Arinaitwe, Emmanuel; Jagannathan, Prasanna; Boyle, Michelle J.; Tappero, Jordan; Muhindo, Mary; Kamya, Moses R.; Dorsey, Grant; Drakeley, Chris; Ssewanyana, Isaac; Smith, David L.; Greenhouse, Bryan

2016-01-01

Background. Plasmodium falciparum malaria remains a leading cause of childhood morbidity and mortality. There are important gaps in our understanding of the factors driving the development of antimalaria immunity as a function of age and exposure. Methods. We used data from a cohort of 93 children participating in a clinical trial in Tororo, Uganda, an area of very high exposure to P. falciparum. We jointly quantified individual heterogeneity in the risk of infection and the development of immunity against infection and clinical disease. Results. Results showed significant heterogeneity in the hazard of infection and independent effects of age and cumulative number of infections on the risk of infection and disease. The risk of developing clinical malaria upon infection decreased on average by 6% (95% confidence interval [CI], 0%–12%) for each additional year of age and by 2% (95% CI, 1%–3%) for each additional prior infection. Children randomly assigned to receive dihydroartemisinin-piperaquine for treatment appeared to develop immunity more slowly than those receiving artemether-lumefantrine. Conclusions. Heterogeneity in P. falciparum exposure and immunity can be independently evaluated using detailed longitudinal studies. Improved understanding of the factors driving immunity will provide key information to anticipate the impact of malaria-control interventions and to understand the mechanisms of clinical immunity. PMID:27481862

Shame, trauma, temperament and psychopathology: Construct validity of the Experience of Shame Scale.

PubMed

Vizin, Gabriella; Urbán, Róbert; Unoka, Zsolt

2016-12-30

Although Experience of Shame Scale (ESS) is used in clinical research and it covers psychiatrically relevant dimensions of chronic shame, characterological (CS), behavioral (BS) and bodily (BoS) respectively, its factor structures were not confirmed on clinical sample. The goals of our research were to examine the factor structure of the Hungarian version of ESS, in addition, to analyze the associations between factors of ESS and different types of predictors, such as clinical status, gender, age, school years, early abuse history, general psychopathology (GSI), and temperament dimensions by using a series of confirmatory factor analyses (CFA) with covariates in a large clinical and matched healthy sample. Psychiatric inpatients (N=148) and healthy control subjects (N=148) participated in this cross-sectional questionnaire study. In both samples, the degree of fit was adequate. The final CFA with covariates model showed significant and positive associations between CS and clinical status and education respectively, between CS, BS, BoS and frequency of verbal abuse, between CS and BoS and GSI and between CS and BS and harm avoidance and in addition we found negative associations between each of the shame factors and age. Our results support the psychiatric validity of the ESS construct. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms.

PubMed

Sdrulla, Andrei D; Guan, Yun; Raja, Srinivasa N

2018-03-11

Spinal cord stimulation (SCS) is a minimally invasive therapy used for the treatment of chronic neuropathic pain. SCS is a safe and effective alternative to medications such as opioids, and multiple randomized controlled studies have demonstrated efficacy for difficult-to-treat neuropathic conditions such as failed back surgery syndrome. Conventional SCS is believed mediate pain relief via activation of dorsal column Aβ fibers, resulting in variable effects on sensory and pain thresholds, and measurable alterations in higher order cortical processing. Although potentiation of inhibition, as suggested by Wall and Melzack's gate control theory, continues to be the leading explanatory model, other segmental and supraspinal mechanisms have been described. Novel, non-standard, stimulation waveforms such as high-frequency and burst have been shown in some studies to be clinically superior to conventional SCS, however their mechanisms of action remain to be determined. Additional studies are needed, both mechanistic and clinical, to better understand optimal stimulation strategies for different neuropathic conditions, improve patient selection and optimize efficacy. © 2018 World Institute of Pain.

A quasi-experimental study examining New York State's tobacco-free regulation: effects on clinical practice behaviors.

PubMed

Eby, Lillian T; Laschober, Tanja C

2013-09-01

On July 24, 2008, New York State (NYS) became the first state to require all state-funded or state-certified substance use disorder (SUD) treatment organizations to be 100% tobacco-free and offer tobacco cessation (TC) treatment. The current study used a quasi-experimental, non-equivalent control group design with a pretest and posttest to examine the effect of the NYS tobacco-free regulation on three clinical practice behaviors (use of TC-related intake procedures, use of guideline recommended counseling for TC, and pharmacotherapy availability) in a diverse sample of SUD treatment programs. Repeated cross-sectional data were collected from NYS counselors (experimental group) and non-NYS counselors (control group) approximately 4 months pre-regulation (N=282 and 659, respectively) and 10-12 months post-regulation (N=364 and 733, respectively). Using mixed-effects models, results at pre-regulation indicate no group differences in the three clinical practice behaviors. However, significant post-regulation effects were found such that the experimental group reports greater use of TC-related intake procedures, guideline recommended counseling, and availability of pharmacotherapy than the control group. Additionally, the experimental but not the control group shows increases in all three clinical practice behaviors from pre-regulation to post-regulation. We conclude that the NYS tobacco-free regulation had a significant and positive effect on promoting patient TC efforts among counselors. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly

PubMed Central

Christofides, Elena A

2016-01-01

In acromegaly, achieving biochemical control (growth hormone [GH] level <1.0 ng/mL and age- and sex-normalized levels of insulin-like growth factor 1 [IGF-1]) through timely diagnosis and appropriate treatment provides an opportunity to improve patient outcomes. Diagnosis of acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

Assessing the accuracy of blood RNA profiles to identify patients with post-concussion syndrome: A pilot study in a military patient population.

PubMed

Hardy, Jimmaline J; Mooney, Scott R; Pearson, Andrea N; McGuire, Dawn; Correa, Daniel J; Simon, Roger P; Meller, Robert

2017-01-01

Mild traumatic brain injury (mTBI) is a complex, neurophysiological condition that can have detrimental outcomes. Yet, to date, no objective method of diagnosis exists. Physical damage to the blood-brain-barrier and normal waste clearance via the lymphatic system may enable the detection of biomarkers of mTBI in peripheral circulation. Here we evaluate the accuracy of whole transcriptome analysis of blood to predict the clinical diagnosis of post-concussion syndrome (PCS) in a military cohort. Sixty patients with clinically diagnosed chronic concussion and controls (no history of concussion) were recruited (retrospective study design). Male patients (46) were split into a training set comprised of 20 long-term concussed (> 6 months and symptomatic) and 12 controls (no documented history of concussion). Models were validated in a testing set (control = 9, concussed = 5). RNA_Seq libraries were prepared from whole blood samples for sequencing using a SOLiD5500XL sequencer and aligned to hg19 reference genome. Patterns of differential exon expression were used for diagnostic modeling using support vector machine classification, and then validated in a second patient cohort. The accuracy of RNA profiles to predict the clinical diagnosis of post-concussion syndrome patients from controls was 86% (sensitivity 80%; specificity 89%). In addition, RNA profiles reveal duration of concussion. This pilot study shows the potential utility of whole transcriptome analysis to establish the clinical diagnosis of chronic concussion syndrome.

Effectiveness of cognitive behavioural therapy in a community-based pulmonary rehabilitation programme: A controlled clinical trial.

PubMed

Luk, Edwin K; Gorelik, Alexandra; Irving, Louis; Khan, Fary

2017-03-06

To investigate whether the use of cognitive behavioural therapy in pulmonary rehabilitation addresses the depression and anxiety burden and thereby improves rehabilitation outcomes. Prospective controlled clinical trial. A total of 70 patients with chronic obstructive pulmonary disease who were referred to a community centre for pulmonary rehabilitation. Patients were allocated to either the control group, consisting of pulmonary rehabilitation alone, or to the treatment group, receiving pulmonary rehabilitation and an additional 6 sessions of group-based cognitive behavioural therapy. Assessments consisting of questionnaires and walk tests were conducted pre- and post-pulmonary rehabilitation. A total of 28 patients were enrolled. The cognitive behavioural therapy group had significant improvements in exercise capacity following pulmonary rehabilitation (mean change 32.9 m, p = 0.043), which was maintained at 3 months post-pulmonary rehabilitation (mean change 23.4 m, p = 0.045). Patients in the cognitive behavioural therapy group showed significant short-term improvements in fatigue, stress and depression (mean change 2.4, p = 0.016, 3.9, p = 0.024 and 4.3, p = 0.047, respectively) and a 3-month post-pulmonary rehabilitation improvement in anxiety score (mean change 3.1, p = 0.01). No significant changes were seen in the control group. The addition of cognitive behavioural therapy improved patients' physical, psychological and quality of life results. Cognitive behavioural therapy should be considered for inclusion in a pulmonary rehabilitation programme to enhance outcomes.

Efficacy of the resilience and adjustment intervention after traumatic brain injury: a randomized controlled trial.

PubMed

Kreutzer, Jeffrey S; Marwitz, Jennifer H; Sima, Adam P; Mills, Ana; Hsu, Nancy H; Lukow, Herman R

2018-05-24

Examine a psychoeducational and skill-building intervention's effectiveness for individuals after traumatic brain injury (TBI), using a two-arm, parallel, randomized, controlled trial with wait-listed control. The Resilience and Adjustment Intervention (RAI) targets adjustment challenges and emphasizes education, skill-building and psychological support. Overall, 160 outpatients were randomly assigned to a treatment or wait-list control (WLC) group. The manualized treatment was delivered in seven 1-h sessions. The Connor-Davidson Resilience Scale (CD-RISC) was the primary outcome measure. Secondary measures included the Mayo Portland Adaptability Inventory-4 (MPAI-4), Brief Symptom Inventory-18 (BSI-18) and 13-Item Stress Test. After adjusting for injury severity, education and time postinjury, the RAI group (N = 75) demonstrated a significantly greater increase in resilience (effect size = 1.03) compared to the WLC group (N = 73). Participants in the RAI group demonstrated more favourable scores on the MPAI-4 Adjustment and Ability Indices, BSI-18 and the 13-item Stress Test. However, only the CD-RISC and BSI-18 demonstrated a clinically significant difference. In addition, RAI participants demonstrated maintenance of gains from pre-treatment to 3-month follow-up; however, only the BSI-18 maintained a clinically significant difference. Investigation provided evidence that a resilience-focused intervention can improve psychological health and adjustment after TBI. Additional research is needed to ascertain the longer term benefits of intervention and the efficacy of alternative delivery methods (e.g., via telephone, Internet).

Perceptions and misconceptions regarding the Joint Commission's view of quality monitoring.

PubMed

Patterson, C H

1989-10-01

The Joint Commission recently has revised its hospital standards for infection control to reflect more accurately current state-of-the-art practices. In addition, the Joint Commission's Agenda for Change initiatives include the development of clinical indicators; one of the topics that will be included in those clinical indicator sets will be infection control. How the hospital chooses to organize itself to conduct the historically required monitoring and evaluation of clinical patient care currently required by the standards of the Joint Commission is at the option of the hospital. How the hospital will organize and collect data specific to infection control indicators yet to be developed by the Joint Commission has not been determined and will not be defined until specific research and development projects are completed. The hospital is expected to have in place infection prevention, surveillance, and control programs; it also is expected to have in place a quality assurance program that focuses not only on solving identified problems but also on the improvement of patient care quality. How the hospitals organize and/or integrate these activities is also at its option. It is expected that qualified professionals will direct and enforce infection prevention, surveillance, and control practices; indicators for infection control can provide data that will help assess the relative success of those practices and activities. The Joint Commission is not developing the capability to judge, on its own part, the actual quality of care provided by an organization seeking accreditation. Rather, the Joint Commission is committed to developing more accurate means to evaluate the structures, processes, and outcomes of diagnosis and treatment activities, as well as their interrelationships. Clinical excellence is supported by quality in the organizational environment and the managerial and leadership contexts within which patient care is delivered. Both clinical and organizational excellence are essential components of quality, and the Joint Commission is convinced that it is appropriate and timely to undertake more direct assessments of both.

[Application of clinical nursing path integrated with holistic nursing in advanced schistosomiasis patients with ascites].

PubMed

Mei-Zhi, Yuan; Jing-Ru, Sun; Tao, Chen; Xiao-Yu, Zhang; Liang-Cai, He; Jia-Song, Wang

2016-05-12

To evaluate the effect of the clinical nursing path integrated with the holistic nursing on advanced schistosomiasis patients with ascites. A total of 226 advanced schistosomiasis patients with ascites were randomly divided into a control group and an experimental group (113 cases each group). The subjects in the experimental group were nursed by the clinical nursing path integrated with the holistic nursing, while those in the control group were nursed only by the holistic nursing. Then the clinical relevant indexes of the two groups were observed, and the quality of life of the patients before and after hospital discharge was assessed. The improvement rate, satisfaction degree, and awareness rate of health knowledge of the patients in the experiment group were 93.8%, 100% and 97.4%, respectively, which were significantly higher than those of the control group (all P < 0.05). The mortality rate and the complication rate of the patients in the experimental group were 0 and 2.7%, respectively, which were significantly lower than those of the control group (both P < 0.05). In addition, the average hospitalization days and the hospitalization cost of the experiment group were (12.2 ± 0.7) d and (4 725.0 ± 310.1) Yuan respectively, which were less than those of the control group (both P < 0.01). When 6 months after the discharge from hospital, the quality of life of the patients in the experimental group in various fields was significantly better than that of the control group (all P < 0.05). The clinical nursing pathway integrated with holistic nursing can effectively improve the improvement rate and decrease the mortality of the advanced schistosomiasis patients with ascites; meanwhile, it can shorten the hospitalization time and save the hospitalization cost. Therefore, this nursing model is suitable for popularization and application in the treatment and nursing work of the advanced schistosomiasis assistance.

Self-blood pressure monitoring in an urban, ethnically diverse population: a randomized clinical trial utilizing the electronic health record.

PubMed

Yi, Stella S; Tabaei, Bahman P; Angell, Sonia Y; Rapin, Anne; Buck, Michael D; Pagano, William G; Maselli, Frank J; Simmons, Alvaro; Chamany, Shadi

2015-03-01

Hypertension is a leading risk factor for cardiovascular disease. Although control rates have improved over time, racial/ethnic disparities in hypertension control persist. Self-blood pressure monitoring, by itself, has been shown to be an effective tool in predominantly white populations, but less studied in minority, urban communities. These types of minimally intensive approaches are important to test in all populations, especially those experiencing related health disparities, for broad implementation with limited resources. The New York City Health Department in partnership with community clinic networks implemented a randomized clinical trial (n=900, 450 per arm) to investigate the effectiveness of self-blood pressure monitoring in medically underserved and largely black and Hispanic participants. Intervention participants received a home blood pressure monitor and training on use, whereas control participants received usual care. After 9 months, systolic blood pressure decreased (intervention, 14.7 mm Hg; control, 14.1 mm Hg; P=0.70). Similar results were observed when incorporating longitudinal data and calculating a mean slope over time. Control was achieved in 38.9% of intervention and 39.1% of control participants at the end of follow-up; the time-to-event experience of achieving blood pressure control in the intervention versus control groups were not different from each other (logrank P value =0.91). Self-blood pressure monitoring was not shown to improve control over usual care in this largely minority, urban population. The patient population in this study, which included a high proportion of Hispanics and uninsured persons, is understudied. Results indicate these groups may have additional meaningful barriers to achieving blood pressure control beyond access to the monitor itself. http://clinicaltrials.gov. Unique Identifier: NCT01123577. © 2015 American Heart Association, Inc.

Peri-operative anaesthetic myocardial preconditioning and protection – cellular mechanisms and clinical relevance in cardiac anaesthesia

PubMed Central

Kunst, G; Klein, A A

2015-01-01

Preconditioning has been shown to reduce myocardial damage caused by ischaemia–reperfusion injury peri-operatively. Volatile anaesthetic agents have the potential to provide myocardial protection by anaesthetic preconditioning and, in addition, they also mediate renal and cerebral protection. A number of proof-of-concept trials have confirmed that the experimental evidence can be translated into clinical practice with regard to postoperative markers of myocardial injury; however, this effect has not been ubiquitous. The clinical trials published to date have also been too small to investigate clinical outcome and mortality. Data from recent meta-analyses in cardiac anaesthesia are also not conclusive regarding intra-operative volatile anaesthesia. These inconclusive clinical results have led to great variability currently in the type of anaesthetic agent used during cardiac surgery. This review summarises experimentally proposed mechanisms of anaesthetic preconditioning, and assesses randomised controlled clinical trials in cardiac anaesthesia that have been aimed at translating experimental results into the clinical setting. PMID:25764404

Influenza-Associated Parotitis During the 2014-2015 Influenza Season in the United States.

PubMed

Rolfes, Melissa A; Millman, Alexander J; Talley, Pamela; Elbadawi, Lina I; Kramer, Natalie A; Barnes, John R; Blanton, Lenee; Davis, Jeffrey P; Cole, Stefanie; Dreisig, John J; Garten, Rebecca; Haupt, Thomas; Jackson, Mary Anne; Kocharian, Anna; Leifer, Daniel; Lynfield, Ruth; Martin, Karen; McHugh, Lisa; Robinson, Sara; Turabelidze, George; Webber, Lori A; Pearce Weinberg, Meghan; Wentworth, David E; Finelli, Lyn; Jhung, Michael A

2018-03-30

During the 2014-2015 influenza season in the United States, 256 cases of influenza-associated parotitis were reported from 27 states. We conducted a case-control study and laboratory investigation to further describe this rare clinical manifestation of influenza. During February 2015-April 2015, we interviewed 50 cases (with parotitis) and 124 ill controls (without parotitis) with laboratory-confirmed influenza; participants resided in 11 states and were matched by age, state, hospital admission status, and specimen collection date. Influenza viruses were characterized using real-time polymerase chain reaction and next-generation sequencing. We compared cases and controls using conditional logistic regression. Specimens from additional reported cases were also analyzed. Cases, 73% of whom were aged <20 years, experienced painful (86%), unilateral (68%) parotitis a median of 4 (range, 0-16) days after onset of systemic or respiratory symptoms. Cases were more likely than controls to be male (76% vs 51%; P = .005). We detected influenza A(H3N2) viruses, genetic group 3C.2a, in 100% (32/32) of case and 92% (105/108) of control specimens sequenced (P = .22). Influenza B and A(H3N2) 3C.3 and 3C.3b genetic group virus infections were detected in specimens from additional cases. Influenza-associated parotitis, as reported here and in prior sporadic case reports, seems to occur primarily with influenza A(H3N2) virus infection. Because of the different clinical and infection control considerations for mumps and influenza virus infections, we recommend clinicians consider influenza in the differential diagnoses among patients with acute parotitis during the influenza season.

Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers.

PubMed

Lynch, Elizabeth B; Liebman, Rebecca; Ventrelle, Jennifer; Keim, Kathryn; Appelhans, Bradley M; Avery, Elizabeth F; Tahsin, Bettina; Li, Hong; Shapera, Merle; Fogelfeld, Leon

2014-11-01

The Lifestyle Improvement through Food and Exercise (LIFE) study is a community-based randomized-controlled trial to measure the effectiveness of a lifestyle intervention to improve glycemic control among African Americans with type 2 diabetes attending safety net clinics. The study enrolled African American adults with a diagnosis of type 2 diabetes and HbA1c ≥ 7.0 who had attended specific safety net community clinics in the prior year. 210 patients will be enrolled and randomized to either the LIFE intervention or a standard of care control group, which consists of two dietitian-led diabetes self-management classes. The LIFE intervention was delivered in 28 group sessions over 12 months and focused on improving diet through dietitian-led culturally-tailored nutrition education, increasing physical activity through self-monitoring using an accelerometer, increasing ability to manage blood sugar through modifications to lifestyle, and providing social support for behavior change. In addition to the group sessions, peer supporters made regular telephone calls to participants to monitor progress toward behavioral goals and provide social support. The 12-month intervention phase was followed by a six-month maintenance phase consisting of two group sessions. The primary outcome of the study is change in A1C from baseline to 12 months, and an additional follow-up will occur at 18 months. The hypothesis of the study is that the participants in the LIFE intervention will show a greater improvement in glycemic control over 12 months than participants in the control group. Copyright © 2014 Elsevier Inc. All rights reserved.

Patterns of disease control and survival in patients with melanoma brain metastases undergoing immune-checkpoint blockade.

PubMed

Milsch, Laura; Gesierich, Anja; Kreft, Sophia; Livingstone, Elisabeth; Zimmer, Lisa; Goebeler, Matthias; Schadendorf, Dirk; Schilling, Bastian

2018-06-12

Immune-checkpoint blockers (ICBs) significantly prolong overall survival (OS) in patients with advanced melanoma. Limited data are available on the efficacy and clinical benefit in patients with melanoma brain metastases (MBMs). The aim of this study was to determine whether ICB is active in an unselected cohort treated of patients with known brain metastases and if disease control correlates with the survival. A total of 385 patients with metastatic malignant melanoma treated with ICB as monotherapy between 2005 and 2017 in two tertiary referral centres were included. Patient records were searched for the development of brain metastases. Demographic and clinical data of all patients were collected retrospectively. We identified 177 patients with MBM who received ICBs (ipilimumab, nivolumab, pembrolizumab). Patients with and without brain metastases received similar ICB regimens. Prognosis was inferior in patients with brain metastases; patients with >1 brain metastasis showed even poorer survival. For extracranial (ec) metastases, disease control was associated with improved survival. However, when comparing patients with intracranial (ic) disease control during immunotherapy to patients with ic disease progression, no difference in OS could be observed. In our study, ec disease control was the dominant predictive factor for OS in both patients with or without melanoma brain metastases. These data indicate that clinical trials in melanoma patients with brain metastases should address end-points such as symptom control, quality of life or OS in addition to ic response rates. Copyright © 2018 Elsevier Ltd. All rights reserved.

The use of autologous platelet-rich plasma in the orthopedic setting.

PubMed

Cohn, Claudia S; Lockhart, Evelyn; McCullough, J Jeffrey

2015-07-01

Autologous platelet-rich plasma (aPRP) is widely used with orthopedic patients to help treat injuries to tendons, cartilage, ligaments, and muscle. A comprehensive review of the literature was conducted to evaluate aPRP's efficacy and compare available methods. In addition, the production and administration of aPRP were explored. A literature search was performed. Randomized controlled clinical trials (RCTs) in orthopedic procedures on adult patients were included and assessed for methodologic quality. The main outcomes were pain relief, increase in function, structural integrity, and "healing" based on various validated scales. Twelve RCTs and one controlled cohort were included (four lateral epicondylitis, two chronic Achilles tendinopathy, two anterior cruciate ligament injury, and five rotator cuff injuries). Four trials reported some benefit from aPRP versus controls while eight trials found no benefit from aPRP applications versus control. One study had too many patients withdraw from the control arm for acceptable data interpretation. All protocols used a different aPRP formulation or method of delivery or application. Despite its popularity, there are no standardized criteria that define aPRP. Different techniques yield wide variability in terms of platelet count and concentration. These variations make it difficult to compare clinical trials that use aPRP or draw conclusions concerning its clinical efficacy in orthopedic procedures. Blood bankers have experience in the production of standardized blood components. This expertise may be used to develop and implement protocols for the production and administration of aPRP, as well as quality control measures. © 2015 AABB.

Short- and long-term effects of a six-week clinical Pilates program in addition to physical therapy on postmenopausal women with chronic low back pain: a randomized controlled trial.

PubMed

Cruz-Díaz, David; Martínez-Amat, Antonio; Osuna-Pérez, M C; De la Torre-Cruz, M J; Hita-Contreras, Fidel

2016-01-01

To determine the short- and long-term effectiveness of the application of Clinical Pilates in addition to physical therapy versus a physical therapy treatment alone in a population of postmenopausal women with chronic low back pain (CLBP). A single-blind randomized controlled trial with repeated measures and a follow-up period. One hundred and one patients were randomly allocated to a Pilates + physical therapy (PPT) group or to a physical therapy (PT) only group for six weeks. Pain and disability were measured by visual analog scale (VAS) and the Oswestry disability index respectively preintervention, after 6 weeks of treatment and after 1-year follow-up. There were significant differences between groups in pain and disability after 6 weeks of treatment, with better results in the PPT group with an effect size of d = 3.14 and d = 2.33 for pain and disability. After 1-year follow-up, only PPT group showed better results compared with baseline with an effect size of d = 2.49 and d = 4.98 for pain and disability. The results suggest that using Clinical Pilates in addition to physical therapy provides improved results on pain management and functional status for postmenopausal woman with CLBP and that its benefits still linger after one year. Chronic Low Back Pain could benefit from the Pilates practice in postmenopausal women. Improvement in pain and disability derived from CLBP seem to be maintained over time due to Pilates practice. Pilates constitutes a safe tool to be applied in older population with CLBP due to its ability to be adapted to every performance and physical level.

Designing and Evaluating an Interactive Multimedia Web-Based Simulation for Developing Nurses’ Competencies in Acute Nursing Care: Randomized Controlled Trial

PubMed Central

Wong, Lai Fun; Chan, Sally Wai-Chi; Ho, Jasmine Tze Yin; Mordiffi, Siti Zubaidah; Ang, Sophia Bee Leng; Goh, Poh Sun; Ang, Emily Neo Kim

2015-01-01

Background Web-based learning is becoming an increasingly important instructional tool in nursing education. Multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice. Objective This study aims to describe the design, development, and evaluation of an interactive multimedia Web-based simulation for developing nurses’ competencies in acute nursing care. Methods Authentic nursing activities were developed in a Web-based simulation using a variety of instructional strategies including animation video, multimedia instructional material, virtual patients, and online quizzes. A randomized controlled study was conducted on 67 registered nurses who were recruited from the general ward units of an acute care tertiary hospital. Following a baseline evaluation of all participants’ clinical performance in a simulated clinical setting, the experimental group received 3 hours of Web-based simulation and completed a survey to evaluate their perceptions of the program. All participants were re-tested for their clinical performances using a validated tool. Results The clinical performance posttest scores of the experimental group improved significantly (P<.001) from the pretest scores after the Web-based simulation. In addition, compared to the control group, the experimental group had significantly higher clinical performance posttest scores (P<.001) after controlling the pretest scores. The participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the Web-based simulation. Themes emerging from the comments about the most valuable aspects of the Web-based simulation include relevance to practice, instructional strategies, and fostering problem solving. Conclusions Engaging in authentic nursing activities using interactive multimedia Web-based simulation can enhance nurses’ competencies in acute care. Web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency. PMID:25583029

Designing and evaluating an interactive multimedia Web-based simulation for developing nurses' competencies in acute nursing care: randomized controlled trial.

PubMed

Liaw, Sok Ying; Wong, Lai Fun; Chan, Sally Wai-Chi; Ho, Jasmine Tze Yin; Mordiffi, Siti Zubaidah; Ang, Sophia Bee Leng; Goh, Poh Sun; Ang, Emily Neo Kim

2015-01-12

Web-based learning is becoming an increasingly important instructional tool in nursing education. Multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice. This study aims to describe the design, development, and evaluation of an interactive multimedia Web-based simulation for developing nurses' competencies in acute nursing care. Authentic nursing activities were developed in a Web-based simulation using a variety of instructional strategies including animation video, multimedia instructional material, virtual patients, and online quizzes. A randomized controlled study was conducted on 67 registered nurses who were recruited from the general ward units of an acute care tertiary hospital. Following a baseline evaluation of all participants' clinical performance in a simulated clinical setting, the experimental group received 3 hours of Web-based simulation and completed a survey to evaluate their perceptions of the program. All participants were re-tested for their clinical performances using a validated tool. The clinical performance posttest scores of the experimental group improved significantly (P<.001) from the pretest scores after the Web-based simulation. In addition, compared to the control group, the experimental group had significantly higher clinical performance posttest scores (P<.001) after controlling the pretest scores. The participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the Web-based simulation. Themes emerging from the comments about the most valuable aspects of the Web-based simulation include relevance to practice, instructional strategies, and fostering problem solving. Engaging in authentic nursing activities using interactive multimedia Web-based simulation can enhance nurses' competencies in acute care. Web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency.

Comparing federal and state healthcare provider performance in villages targeted by the conditional cash transfer programme of Mexico.

PubMed

Bustamante, Arturo Vargas

2011-10-01

This study investigates household out-of-pocket healthcare expenditures (OPH) and preventive care utilization (PHU) to compare federal and state healthcare provider performance in villages targeted by conditional cash transfer (CCT) programmes in poor rural areas of Mexico. Lower OPH and higher PHU are indicative of better performance in the study setting. Log-linear and probit regression models were used to compare outcomes in households from treatment and control villages reached by federal and state healthcare providers. In treatment villages, eligible households receive cash grants from the CCT programme. In control villages, eligible households do not receive cash grants from the CCT programme at the time of the survey. Families who live in treatment villages reported lower OPH (-52.5% for federal and -46.2% for state clinics) and higher PHU (21% for federal and 20% for state clinics) regardless of clinic setting. As the reduction in OPH is higher in areas reached by the federal clinics, it implies better performance from this healthcare delivery system. Additionally, federal clinic outcomes were also more homogeneous because OPH are not significantly different between treatment and control villages. Alternative measures such as drug and physician expenditures, diabetes and hypertension tests and nutritional-supplement receipt confirmed these findings. Mexico has two healthcare delivery systems that cater to identical rural populations. The better-funded and more centralized federal system is more effective at providing health care in poor rural villages of Mexico regardless of CCT participation. State clinics in villages targeted by the CCT programme, however, perform significantly better. © 2011 Blackwell Publishing Ltd.

Muscle-related side-effects of statins: from mechanisms to evidence-based solutions.

PubMed

Taylor, Beth A; Thompson, Paul D

2015-06-01

This article highlights the recent findings regarding statin-associated muscle side effects, including mechanisms and treatment as well as the need for more comprehensive clinical trials in statin myalgia. Statin myalgia is difficult to diagnose and treat, as major clinical trials have not routinely assessed muscle side-effects, there are few clinically relevant biomarkers and assessment tools for the symptoms, many apparent statin-related muscle symptoms may be nonspecific and related to other drugs or health conditions, and prevalence estimates vary widely. Data thus suggest that only 30-50% of patients with self-reported statin myalgia actually experience muscle pain on statins during blinded, placebo-controlled trials. In addition, evidence to date involving mechanisms underlying statin myalgia and its range of symptoms and presentations supports the hypothesis that there are multiple, interactive and potentially additive mechanisms underlying statin-associated muscle side-effects. There are likely multiple and interactive mechanisms underlying statin myalgia, and recent studies have produced equivocal data regarding prevalence of statin-associated muscle side-effects, contributing factors and effectiveness of common interventions. Therefore, more clinical trials on statin myalgia are critical to the field, as are systematic resources for quantifying, predicting and reporting statin-associated muscle side-effects.

Statins for the prevention of contrast-induced acute kidney injury.

PubMed

Vanmassenhove, Jill; Vanholder, Raymond; Lameire, Norbert

2016-11-01

To highlight the most recently published meta-analyses on the role of statins in the prevention of contrast-induced acute kidney injury (CI-AKI) and to formulate recommendations for clinical practice. Nine meta-analyses were published on this topic from January 2015 to April 2016. Significant clinical heterogeneity between studies, regarding study population, treatment protocol, concomitant preventive strategies or dosage and duration of statin therapy was observed. In addition, the definition of CI-AKI was not uniform throughout all studies, and a number of other clinically meaningful endpoints, such as length of hospital stay in patients who developed CI-AKI, as well as adverse events, were rarely analyzed. Despite some promising results, it is premature to adapt the existing guidelines and implement the preprocedural use of statins in daily clinical practice. At present, low volumes of iso-osmolar or low-osmolar intravascular contrast and adequate intravascular hydration in high-risk patients remain the cornerstone for the prevention of CI-AKI. There is a need for additional well designed randomized controlled trials to clarify these issues and assess the risk vs benefit of statin use for the purpose of CI-AKI prevention.

Technical pre-analytical effects on the clinical biochemistry of Atlantic salmon (Salmo salar L.).

PubMed

Braceland, M; Houston, K; Ashby, A; Matthews, C; Haining, H; Rodger, H; Eckersall, P D

2017-01-01

Clinical biochemistry has long been utilized in human and veterinary medicine as a vital diagnostic tool, but despite occasional studies showing its usefulness in monitoring health status in Atlantic salmon (Salmo salar L.), it has not yet been widely utilized within the aquaculture industry. This is due, in part, to a lack of an agreed protocol for collection and processing of blood prior to analysis. Moreover, while the analytical phase of clinical biochemistry is well controlled, there is a growing understanding that technical pre-analytical variables can influence analyte concentrations or activities. In addition, post-analytical interpretation of treatment effects is variable in the literature, thus making the true effect of sample treatment hard to evaluate. Therefore, a number of pre-analytical treatments have been investigated to examine their effect on analyte concentrations and activities. In addition, reference ranges for salmon plasma biochemical analytes have been established to inform veterinary practitioners and the aquaculture industry of the importance of clinical biochemistry in health and disease monitoring. Furthermore, a standardized protocol for blood collection has been proposed. © 2016 The Authors Journal of Fish Diseases Published by John Wiley & Sons Ltd.

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

PubMed

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

2012-03-01

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

Bupropion for the treatment of apathy in Huntington’s disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial

PubMed Central

Gelderblom, Harald; Wüstenberg, Torsten; McLean, Tim; Mütze, Lisanne; Fischer, Wilhelm; Saft, Carsten; Hoffmann, Rainer; Süssmuth, Sigurd; Schlattmann, Peter; van Duijn, Erik; Landwehrmeyer, Bernhard; Priller, Josef

2017-01-01

Objective To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD). Methods In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy—Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI). Results At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator. Conclusion Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD. Trial registration ClinicalTrials.gov 01914965 PMID:28323838

Effects of antenatal care and HIV treatment integration on elements of the PMTCT cascade: Results from the SHAIP cluster-randomized controlled trial in Kenya

PubMed Central

Turan, Janet M.; Onono, Maricianah; Steinfeld, Rachel L.; Shade, Starley B.; Owuor, Kevin; Washington, Sierra; Bukusi, Elizabeth A.; Ackers, Marta L.; Kioko, Jackson; Interis, Evelyn C.; Cohen, Craig R.

2015-01-01

Background Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. The current study aimed to determine if integration of HIV services into ANC settings improves PMTCT service utilization outcomes. Methods ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or non-integrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), while control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. Results HIV care enrollment was higher in intervention compared to control clinics (69% versus 36%, Odds Ratio (OR)=3.94, 95% Confidence Interval (CI): 1.14–13.63). Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, Hazard Ratio (HR)=2.20, 95% CI: 1.62–3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%, OR=3.22, 95% CI: 1.81–5.72). Infant testing was more common in the intervention arm (25% versus 18%), however not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. Conclusions Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions. PMID:25967269

Clinical and microbiological evaluation of high intensity diode laser adjutant to non-surgical periodontal treatment: a 6-month clinical trial.

PubMed

Euzebio Alves, Vanessa Tubero; de Andrade, Ana Karina Pinto; Toaliar, Janaita Maria; Conde, Marina Clemente; Zezell, Denise Maria; Cai, Silvana; Pannuti, Claudio Mendes; De Micheli, Giorgio

2013-01-01

This randomized split-mouth clinical trial was designed to evaluate the efficacy of scaling and root planing associated to the high-intensity diode laser on periodontal therapy by means of clinical parameters and microbial reduction. A total of 36 chronic periodontitis subjects, of both genders, were selected. One pair of contralateral single-rooted teeth with pocket depth >5 mm was chosen from each subject. All patients received non-surgical periodontal treatment, after which the experimental teeth were designated to either test or control groups. Both teeth received scaling, root planing and coronal polishing (SRP) and teeth assigned to the test group (SRP + DL) were irradiated with the 808 ± 5 nm diode laser, for 20 s, in two isolated appointments, 1 week apart. The laser was used in the continuous mode, with 1.5 W and power density of 1,193.7 W/cm(2). Clinical and microbiological data were collected at baseline, 6 weeks and 6 months after therapy. There was a significant improvement of all the clinical parameters-clinical attachment level (CAL), probing depth (PD), plaque index (PI) and Bleeding on Probing (BOP)-for both groups (P < 0.001), with no statistical difference between them at the 6 weeks and the 6 months examinations. As for microbiological analysis, a significant reduction after 6 weeks (P > 0.05) was observed as far as colony forming units (CFU) is concerned, for both groups. As for black-pigmented bacteria, a significant reduction was observed in both groups after 6 months. However, the difference between test and control groups was not significant. There was no association between group and presence of Porphyromonas gingivalis, Prevotella intermedia and Aggregatibacter actinomycetemcomitans at any time of the study. After 6 months of evaluation, the high-intensity diode laser has not shown any additional benefits to the conventional periodontal treatment. The high intensity diode laser did not provide additional benefits to non-surgical periodontal treatment. More studies are necessary to prove the actual need of this type of laser in the periodontal clinical practice.

Molecular characterization of NRXN1 deletions from 19,263 clinical microarray cases identifies exons important for neurodevelopmental disease expression

PubMed Central

Lowther, Chelsea; Speevak, Marsha; Armour, Christine M.; Goh, Elaine S.; Graham, Gail E.; Li, Chumei; Zeesman, Susan; Nowaczyk, Malgorzata J.M.; Schultz, Lee-Anne; Morra, Antonella; Nicolson, Rob; Bikangaga, Peter; Samdup, Dawa; Zaazou, Mostafa; Boyd, Kerry; Jung, Jack H.; Siu, Victoria; Rajguru, Manjulata; Goobie, Sharan; Tarnopolsky, Mark A.; Prasad, Chitra; Dick, Paul T.; Hussain, Asmaa S.; Walinga, Margreet; Reijenga, Renske G.; Gazzellone, Matthew; Lionel, Anath C.; Marshall, Christian R.; Scherer, Stephen W.; Stavropoulos, Dimitri J.; McCready, Elizabeth; Bassett, Anne S.

2016-01-01

Purpose The purpose of the current study was to assess the penetrance of NRXN1 deletions. Methods We compared the prevalence and genomic extent of NRXN1 deletions identified among 19,263 clinically referred cases to that of 15,264 controls. The burden of additional clinically relevant CNVs was used as a proxy to estimate the relative penetrance of NRXN1 deletions. Results We identified 41 (0.21%) previously unreported exonic NRXN1 deletions ascertained for developmental delay/intellectual disability, significantly greater than in controls [OR=8.14 (95% CI 2.91–22.72), p< 0.0001)]. Ten (22.7%) of these had a second clinically relevant CNV. Subjects with a deletion near the 3′ end of NRXN1 were significantly more likely to have a second rare CNV than subjects with a 5′ NRXN1 deletion [OR=7.47 (95% CI 2.36–23.61), p=0.0006]. The prevalence of intronic NRXN1 deletions was not statistically different between cases and controls (p=0.618). The majority (63.2%) of intronic NRXN1 deletion cases had a second rare CNV, a two-fold greater prevalence than for exonic NRXN1 deletion cases (p=0.0035). Conclusions The results support the importance of exons near the 5′ end of NRXN1 in the expression of neurodevelopmental disorders. Intronic NRXN1 deletions do not appear to substantially increase the risk for clinical phenotypes. PMID:27195815

Randomized controlled trials in mild cognitive impairment

PubMed Central

Thomas, Ronald G.; Aisen, Paul S.; Mohs, Richard C.; Carrillo, Maria C.; Albert, Marilyn S.

2017-01-01

Objective: To examine the variability in performance among placebo groups in randomized controlled trials for mild cognitive impairment (MCI). Methods: Placebo group data were obtained from 2 National Institute on Aging (NIA) MCI randomized controlled trials, the Alzheimer's Disease Cooperative Study (ADCS) MCI trial and the Alzheimer's Disease Neuroimaging Initiative (ADNI), which is a simulated clinical trial, in addition to industry-sponsored clinical trials involving rivastigmine, galantamine, rofecoxib, and donepezil. The data were collated for common measurement instruments. The performance of the placebo participants from these studies was tracked on the Alzheimer's Disease Assessment Scale–cognitive subscale, Mini-Mental State Examination, and Clinical Dementia Rating–sum of boxes, and for progression on these measures to prespecified clinical study endpoints. APOE status, where available, was also analyzed for its effects. Results: The progression to clinical endpoints varied a great deal among the trials. The expected performances were seen for the participants in the 2 NIA trials, ADCS and ADNI, with generally worsening of performance over time; however, the industry-sponsored trials largely showed stable or improved performance in their placebo participants. APOE4 carrier status influenced results in an expected fashion on the study outcomes, including rates of progression and cognitive subscales. Conclusions: In spite of apparently similar criteria for MCI being adopted by the 7 studies, the implementation of the criteria varied a great deal. Several explanations including instruments used to characterize participants and variability among study populations contributed to the findings. PMID:28381516

An oral carcinogenicity and toxicity study of senna (Tinnevelly senna fruits) in the rat.

PubMed

Mitchell, J M; Mengs, U; McPherson, S; Zijlstra, J; Dettmar, P; Gregson, R; Tigner, J C

2006-01-01

Senna (Tinnevelly senna fruits), a known laxative derived from plants, was administered by gavage to Sprague-Dawley (Crl:CD (SD) BR) rats once daily at dose levels of 0, 25, 100 and 300 mg/kg/day for up to 104 consecutive weeks. Based upon clinical signs related to the laxation effect of senna, the highest dose (300 mg/kg/day) was considered to be a maximum tolerated dose. Sixty animals per sex were assigned to the control and dose groups. Assessments included clinical chemistry, hematology, full histology (control and high-dose groups; in addition, low and mid dose: intestinal tract, adrenals, liver, kidneys, brain and gross lesions) and toxicokinetics. The primary treatment-related clinical observation was mucoid feces seen at 300 mg/kg/day. When compared to controls, animals administered 300 mg/kg/day had slightly reduced body weights, increased water consumption and notable changes in electrolytes in serum (increases in potassium and chloride) and urine (decreases in sodium, potassium and chloride). The changes in electrolytes are most likely physiologic adaptations to the laxative effect of senna. At necropsy, dark discoloration of the kidneys was observed in animals in all treated groups. Histological changes were seen in the kidneys of animals from all treated groups and included slight to moderate tubular basophilia and tubular pigment deposits. In addition, for all treated groups, minimal to slight hyperplasia was evident in the colon and cecum. These histological changes, together with the changes seen in the evaluation of clinical chemistry and urine parameters, have been shown to be reversible in a previous 13-week rat study of senna. No treatment-related neoplastic changes were observed in any of the examined organs. Based upon these data, it is concluded that senna is not carcinogenic even after daily administration for 2 years at dosages of up to 300 mg/kg/day in Sprague-Dawley rats.

Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial

PubMed Central

Greving, J P; Kaasjager, H A H; Vernooij, J W P; Hovens, M M C; Wierdsma, J; Grandjean, H M H; van der Graaf, Y; de Wit, G A; Visseren, F L J

2015-01-01

Objective To assess the cost-effectiveness of an internet-based, nurse-led vascular risk factor management programme in addition to usual care compared with usual care alone in patients with a clinical manifestation of a vascular disease. Design Cost-effectiveness analysis alongside a randomised controlled trial (the Internet-based vascular Risk factor Intervention and Self-management (IRIS) study). Setting Multicentre trial in a secondary and tertiary healthcare setting. Participants 330 patients with a recent clinical manifestation of atherosclerosis in the coronary, cerebral, or peripheral arteries and with ≥2 treatable vascular risk factors not at goal. Intervention The intervention consisted of a personalised website with an overview and actual status of patients’ vascular risk factors, and mail communication with a nurse practitioner via the website for 12 months. The intervention combined self-management support, monitoring of disease control and pharmacotherapy. Main outcome measures Societal costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness. Results Patients experienced equal health benefits, that is, 0.86 vs 0.85 QALY (intervention vs usual care) at 1 year. Adjusting for baseline differences, the incremental QALY difference was −0.014 (95% CI −0.034 to 0.007). The intervention was associated with lower total costs (€4859 vs €5078, difference €219, 95% CI −€2301 to €1825). The probability that the intervention is cost-effective at a threshold value of €20 000/QALY, is 65%. At mean annual cost of €220 per patient, the intervention is relatively cheap. Conclusions An internet-based, nurse-led intervention in addition to usual care to improve vascular risk factors in patients with a clinical manifestation of a vascular disease does not result in a QALY gain at 1 year, but has a small effect on vascular risk factors and is associated with lower costs. Trial registration number NCT00785031. PMID:25995238

Psychosocial and clinical risk factor profiles in managers.

PubMed

Kentner, M; Ciré, L; Scholl, J

2000-06-01

Over the past 10 years the IAS Foundation has performed more than 15,000 PREVENT check-ups on managers. In addition to a comprehensive clinical program of preventive examinations, the main emphasis is placed on extensive counseling. This counseling centres not only on personal behaviour patterns affecting the individual's health, but also on the psychomental capabilities of the patient within the context of the psychosocial stresses in managerial positions. Three cross-sectional studies examined: (1) the major cardiovascular risk factors (n = 974), (2) the psychosocial structure (n = 2,800) and (3) the relationships between clinical risk factors and psychological structural features (n = 200). According to expectations, managers showed somewhat lower cardiovascular risk levels than did other professional groups. However, nearly 70% of them reported various unspecific, psychovegetative complaints. Managers were subdivided into four psychological types, each representing roughly one quarter of the series: Type 1: anxiety, tension (20.5%); Type 2: repression, lack of self-control (22.2%); Type 3: challenge, ambition, self-control (27.6%); Type 4: healthy living, with self-control (29.7%). Type 3 resembles most closely classic type A behaviour and is seen in a good quarter of the overall cohort. This may indicate that not only people showing type A behaviour are predestined to occupy managerial positions, but that people with a type B structure also take up managerial positions. It is, however, in particular the type B behavioural patterns that are also associated with increased psychovegetative complaints. The relationships between psychosocial structural variables and clinical risk factors such as hypercholesteremia and high blood pressure are not very strong. Occupational health measures in organisations should also be established for managers, as they present an important employee group within the enterprise. In addition to examining them for cardiovascular risks, counseling and coaching programmes on preventive measures and recommended behaviour at work should be a primary concern.

Investigation of Dysphagia After Antireflux Surgery by High-resolution Manometry: Impact of Multiple Water Swallows and a Solid Test Meal on Diagnosis, Management, and Clinical Outcome.

PubMed

Wang, Yu Tien; Tai, Ling Fung; Yazaki, Etsuro; Jafari, Jafar; Sweis, Rami; Tucker, Emily; Knowles, Kevin; Wright, Jeff; Ahmad, Saqib; Kasi, Madhavi; Hamlett, Katharine; Fox, Mark R; Sifrim, Daniel

2015-09-01

Management of patients with dysphagia, regurgitation, and related symptoms after antireflux surgery is challenging. This prospective, case-control study tested the hypothesis that compared with standard high-resolution manometry (HRM) with single water swallows (SWS), adding multiple water swallows (MWS) and a solid test meal increases diagnostic yield and clinical impact of physiological investigations. Fifty-seven symptomatic and 12 asymptomatic patients underwent HRM with SWS, MWS, and a solid test meal. Dysphagia and reflux were assessed by validated questionnaires. Diagnostic yield of standard and full HRM studies with 24-hour pH-impedance monitoring was compared. Pneumatic dilatation was performed for outlet obstruction on HRM studies. Clinical outcome was assessed by questionnaires and an analogue scale with "satisfactory" defined as at least 40% symptom improvement requiring no further treatment. Postoperative esophagogastric junction pressure was similar in all groups. Abnormal esophagogastric junction morphology (double high pressure band) was more common in symptomatic than in control patients (13 of 57 vs 0 of 12, P = .004). Diagnostic yield of HRM was 11 (19%), 11 (19%), and 33 of 57 (58%), with SWS, MWS, and solids, respectively (P < .001); it was greatest for solids in patients with dysphagia (19 of 27, 70%). Outlet obstruction was present in 4 (7%), 11 (19%), and 15 of 57 patients (26%) with SWS, MWS, and solids, respectively (P < .009). No asymptomatic control had clinically relevant dysfunction on solid swallows. Dilatation was performed in 12 of 15 patients with outlet obstruction during the test meal. Symptom response was satisfactory, good, or excellent in 7 of 12 (58%) with no serious complications. The addition of MWS and a solid test meal increases the diagnostic yield of HRM studies in patients with symptoms after fundoplication and identifies additional patients with outlet obstruction who benefit from endoscopic dilatation. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

A Systematic Review of Experimental and Clinical Acupuncture in Chemotherapy-Induced Peripheral Neuropathy

PubMed Central

Franconi, Giovanna; Schröder, Sven; Marchetti, Paolo; Robinson, Nicola

2013-01-01

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect that can be very disabling and can limit or delay the dose of chemotherapy that can be administered. Acupuncture may be effective for treating peripheral neuropathy. The aim of this study was to review the available literature on the use of acupuncture for CIPN. The systematic literature search was performed using MEDLINE, Google Scholar, Cochrane Database, CINHAL, and ISI Proceedings. Hand searching was conducted, and consensus was reached on all extracted data. Only papers in the English language were included, irrespective of study design. From 3989 retrieved papers, 8 relevant papers were identified. One was an experimental study which showed that electroacupuncture suppressed CIPN pain in rats. In addition, there were 7 very heterogeneous clinical studies, 1 controlled randomised study using auricular acupuncture, 2 randomized controlled studies using somatic acupuncture, and 3 case series/case reports which suggested a positive effect of acupuncture in CIPN. Conclusions. Only one controlled randomised study demonstrated that acupuncture may be beneficial for CIPN. All the clinical studies reviewed had important methodological limitations. Further studies with robust methodology are needed to demonstrate the role of acupuncture for treating CIPN resulting from cancer treatment. PMID:23983788

Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article.

PubMed

Burkus, J Kenneth; Traynelis, Vincent C; Haid, Regis W; Mummaneni, Praveen V

2014-10-01

The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective, randomized, multicenter trial at 7 years of follow-up. At 31 investigational sites, 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups: 276 investigational group patients underwent anterior cervical discectomy and arthroplasty with the Prestige disc, and 265 control group patients underwent anterior cervical discectomy and fusion. Clinical outcomes included Neck Disability Index, the 36-Item Short-Form Health Survey, and neck and arm pain scores. Radiographs were assessed for angle of motion and fusion. Clinical and radiographic outcomes were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, 60, and 84 months. Of the 541 patients treated, 395 patients (73%; 212 investigational and 183 control patients) completed 7 years of clinical follow-up. Significant improvements achieved by 1.5 months in both groups were sustained at 7 years. In the investigational group, mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months, respectively. In the control group, the corresponding means were 33.8 and 31.9. The differences between the investigational and control groups at the 60-month and 84-month periods were significant (p = 0.014 and 0.002, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher: 92.2% and 88.2% at 60 months and 84 months, respectively, compared with 85.7% and 79.7% in the control group (p = 0.017 and 0.011, respectively). At 84 months, the percentage of working patients in the investigational group was 73.9%, and in the control group, 73.1%. Postoperatively, the implant effectively maintained average angular motion of 6.67° at 60 months and 6.75° at 84 months. Cumulative rates for surgery at the index level were lower (p < 0.001) in the investigational group (11 [4.8%] of 276) when compared with the control group (29 [13.7%] of 265) (based on life-table method), and there were statistical differences between the investigational and control groups with specific regard to the rate of subsequent revision and supplemental fixation surgical procedures. Rates for additional surgical procedures that involved adjacent levels were lower in the investigational group than in the control group (11 [4.6%] of 276 vs. 24 [11.9%] of 265, respectively). Cervical disc arthroplasty has the potential for preserving motion at the operated level while providing biomechanical stability and global neck mobility and may result in a reduction in adjacent-segment degeneration. The Prestige Cervical Disc maintains improved clinical outcomes and segmental motion after implantation at 7-year follow-up. Clinical trial registration no. NCT00642876 ( ClinicalTrials.gov ).

Training Load, Immune Status, and Clinical Outcomes in Young Athletes: A Controlled, Prospective, Longitudinal Study

PubMed Central

Blume, Katharina; Körber, Nina; Hoffmann, Dieter; Wolfarth, Bernd

2018-01-01

Introduction: Beside positive effects on athlete's health, competitive sport can be linked with an increased risk of illness and injury. Because of high relative increases in training, additional physical and psychological strains, and an earlier specialization and professionalization, adolescent athletes needs an increased attention. Training can alter the immune system by inducing a temporary immunosuppression, finally developing infection symptoms. Previous studies identified Epstein Barr Virus (EBV) as potential indicator for the immune status. In addition to the identification of triggering risk factors for recurrent infections, the aim was to determine the interaction between training load, stress sense, immunological parameters, and clinical symptoms. Methods: A controlled, prospective, longitudinal study on young athletes (n = 274, mean age: 13.8 ± 1.5 yrs) was conducted between 2010 and 2014. Also 285 controls (students, who did not perform competitive sports, mean age: 14.5 ± 1.9 yrs) were recruited. Athletes were examined 3 times each year to determine the effects of stress factors (training load: training hours per week [Th/w]) on selected outcome parameters (clinical [susceptibility to infection, WURSS-21: 21-item Wisconsin Upper Respiratory Symptom Survey], immunological, psychological end points). As part of each visit, EBV serostatus and EBV-specific IgG tiers were studied longitudinally as potential immune markers. Results: Athletes (A) trained 14.9 ± 5.6 h weekly. Controls (C) showed no lower stress levels compared to athletes (p = 0.387). Twelve percent of athletes reported recurrent infections (C: 8.5%, p = 0.153), the presence of an upper respiratory tract infection (URTI) was achieved in 30.7%. EBV seroprevalence of athletes was 60.3% (C: 56.6%, p = 0.339). Mean EBV-specific IgG titer of athletes was 166 ± 115 U/ml (C: 137 ± 112 U/ml, p = 0.030). With increasing Th/w, higher stress levels were observed (p < 0.001). Analyzes of WURSS-21 data revealed no relationship to training load (p = 0.323). Also, training load had no relation to EBV serostatus (p = 0.057) or the level of EBV-specific IgG titers (p = 0.364). Discussion: Young elite athletes showed no increased sense of stress, no higher prevalence of recurrent infections, and no different EBV-specific serological parameters compared to controls. Also, no direct relationship between training loads, clinical complaints, and EBV-specific immune responses was found. With increasing training loads athletes felt more stressed, but significant associations to EBV-specific serological parameters were absent. In summary, EBV serostatus and EBV-specific IgG titers do not allow risk stratification for impaired health. Further investigations are needed to identify additional risk factors and immune markers, with the aim to avoid inappropriate strains by early detection and following intervention. PMID:29628891

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

PubMed

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

2016-04-02

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

Cognitive control level of action for analyzing verbal reports in educative clinical simulation situations.

PubMed

Morineau, Thierry; Meineri, Sebastien; Chapelain, Pascal

2017-03-01

Several methods and theoretical frameworks have been proposed for efficient debriefing after clinical simulation sessions. In these studies, however, the cognitive processes underlying the debriefing stage are not directly addressed. Cognitive control constitutes a conceptual link between behavior and reflection on behavior to apprehend debriefing cognitively. Our goal was to analyze cognitive control from verbal reports using the Skill-Rule-Knowledge model. This model considers different cognitive control levels from skill-based to rule-based and knowledge-based control. An experiment was conducted with teams of nursing students who were confronted with emergency scenarios during high-fidelity simulation sessions. Participants' descriptions of their actions were asked in the course of the simulation scenarios or during the debriefing stage. 52 nursing students working in 26 pairs participated in this study. Participants were divided into two groups: an "in situ" group in which they had to describe their actions at different moments of a deteriorating patient scenario, and a "debriefing" group, in which, at the same moments, they had to describe their actions displayed on a video recording. In addition to a cognitive analysis, the teams' clinical performance was measured. The cognitive control level in the debriefing group was generally higher than in the in situ group. Good team performance was associated with a high level of cognitive control after a patient's significant state deterioration. These findings are in conformity with the "Skill-Rule-Knowledge" model. The debriefing stage allows a deeper reflection on action compared with the in situ condition. If an abnormal event occurs as an adverse event, then participants' mental processes tend to migrate towards knowledge-based control. This migration particularly concerns students with the best clinical performance. Thus, this cognitive framework can help to strengthen the analysis of verbal reports. Copyright © 2016 Elsevier Ltd. All rights reserved.

Efficacy of mummy on healing of pressure ulcers: A randomized controlled clinical trial on hospitalized patients in intensive care unit

PubMed Central

Moghadari, Masoud; Rezvanipour, Mozafar; Mehrabani, Mitra; Ahmadinejad, Mehdi; Hashempur, Mohammad Hashem

2018-01-01

Background Mummy is a mineral substance which according to Persian medicine texts, may be useful in treatment of chronic ulcers. Objective The present study was performed with the aim of determining the effect of mummy on healing of pressure in male patients who had been hospitalized due to cerebrospinal injury in the Intensive Care Unit. Methods This randomized, placebo-controlled clinical trial was performed on 75 patients who had pressure ulcer at Shahid Bahonar Hospital in Kerman, Iran, from September 2016 to March 2017. The control group received normal saline and routine wound dressing, while the intervention group received mummy water solution 20% in addition to normal saline and routine wound dressing on a daily basis. Data was recorded based on the PUSH method. In both groups, ulcers were evaluated on days 0, 7, 14, 21 and 28 for the variables of ulcer surface area, the amount of exudate and type of tissue. Data analysis was done through SPSS 21 and using t-test, Repeated Measure Analysis, Cox Regression and Chi-square. Results Both groups showed reduction in the average ulcer surface area (3.26 to 0.53 in the intervention group and 5.1 to 3.46 in the control group), the average exudate amount (1.26 to 0.26 in the intervention group and 1.83 to 1.06 in the control group) and the average tissue score (1.36 to 0.23 in the intervention group and 2.13 to 1.26 in the control group). Over the entire study period, the intervention group showed more acceptable signs of healing compared to the control group (p<0.05). Conclusion The healing process was more prominent in the intervention group than the control group. Clinical trial registration The trial was registered at the Iranian Registry of Clinical Trials with registered NO. (IRCT2014042917494N1) (29/04/2014). Funding No financial support for the research. PMID:29588812

Microwave cyclodestruction for glaucoma in a rabbit model

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

Finger, P.T.; Moshfeghi, D.M.; Smith, P.D.

1991-07-01

Microwave thermotherapy was used to treat experimentally induced glaucoma. Microwave-induced cyclodestruction was successful in reducing intraocular pressure in all treated glaucomatous eyes for 4 weeks. Two additional glaucomatous eyes were left untreated to serve as controls, and were noted to have persistently elevated intraocular pressures. Six additional eyes were then subjected to an equivalent treatment (50 degrees C in five 1-minute applications), which resulted in approximately 180 degrees of heat treatment just posterior to the corneoscleral limbus. These specimens were evaluated with light microscopy at baseline, 24 hours, and 7 days after treatment. The authors clinical and histopathologic evaluations suggestedmore » that microwave thermotherapy (delivered under thermometry control) allowed for chorioretinal/ciliary body destruction that resulted in reductions of intraocular pressure in glaucomatous eyes.« less

The role of measuring airway hyperresponsiveness and inflammatory biomarkers in asthma

PubMed Central

Currie, Graeme P; Fardon, Tom C; Lee, Daniel KC

2005-01-01

Asthma is characterized by inflammation and airway hyperresponsiveness, which results in episodic airflow obstruction. It is diagnosed once a compatible clinical history plus objective evidence of diurnal variability in peak expiratory flow or significant reversibility to inhaled bronchodilator is documented. In accordance with current guidelines, measures of airway calibre and symptoms allow patients and clinicians to assess the degree of asthma control and titrate pharmacotherapy. However, these parameters fail to reflect the extent of underlying endobronchial inflammation and airway hyperresponsiveness, which in turn suggests that additional measures of asthma control may be of benefit. This evidence-based review highlights ways by which inflammation and airway hyperresponsiveness can be assessed and how they may provide additional useful information in the diagnosis and management of asthmatic patients. PMID:18360548

Development of Internal Controls for the Luminex Instrument as Part of a Multiplex Seven-Analyte Viral Respiratory Antibody Profile

PubMed Central

Martins, Thomas B.

2002-01-01

The ability of the Luminex system to simultaneously quantitate multiple analytes from a single sample source has proven to be a feasible and cost-effective technology for assay development. In previous studies, my colleagues and I introduced two multiplex profiles consisting of 20 individual assays into the clinical laboratory. With the Luminex instrument’s ability to classify up to 100 distinct microspheres, however, we have only begun to realize the enormous potential of this technology. By utilizing additional microspheres, it is now possible to add true internal controls to each individual sample. During the development of a seven-analyte serologic viral respiratory antibody profile, internal controls for detecting sample addition and interfering rheumatoid factor (RF) were investigated. To determine if the correct sample was added, distinct microspheres were developed for measuring the presence of sufficient quantities of immunoglobulin G (IgG) or IgM in the diluted patient sample. In a multiplex assay of 82 samples, the IgM verification control correctly identified 23 out of 23 samples with low levels (<20 mg/dl) of this antibody isotype. An internal control microsphere for RF detected 30 out of 30 samples with significant levels (>10 IU/ml) of IgM RF. Additionally, RF-positive samples causing false-positive adenovirus and influenza A virus IgM results were correctly identified. By exploiting the Luminex instrument’s multiplexing capabilities, I have developed true internal controls to ensure correct sample addition and identify interfering RF as part of a respiratory viral serologic profile that includes influenza A and B viruses, adenovirus, parainfluenza viruses 1, 2, and 3, and respiratory syncytial virus. Since these controls are not assay specific, they can be incorporated into any serologic multiplex assay. PMID:11777827

Development of internal controls for the Luminex instrument as part of a multiplex seven-analyte viral respiratory antibody profile.

PubMed

Martins, Thomas B

2002-01-01

The ability of the Luminex system to simultaneously quantitate multiple analytes from a single sample source has proven to be a feasible and cost-effective technology for assay development. In previous studies, my colleagues and I introduced two multiplex profiles consisting of 20 individual assays into the clinical laboratory. With the Luminex instrument's ability to classify up to 100 distinct microspheres, however, we have only begun to realize the enormous potential of this technology. By utilizing additional microspheres, it is now possible to add true internal controls to each individual sample. During the development of a seven-analyte serologic viral respiratory antibody profile, internal controls for detecting sample addition and interfering rheumatoid factor (RF) were investigated. To determine if the correct sample was added, distinct microspheres were developed for measuring the presence of sufficient quantities of immunoglobulin G (IgG) or IgM in the diluted patient sample. In a multiplex assay of 82 samples, the IgM verification control correctly identified 23 out of 23 samples with low levels (<20 mg/dl) of this antibody isotype. An internal control microsphere for RF detected 30 out of 30 samples with significant levels (>10 IU/ml) of IgM RF. Additionally, RF-positive samples causing false-positive adenovirus and influenza A virus IgM results were correctly identified. By exploiting the Luminex instrument's multiplexing capabilities, I have developed true internal controls to ensure correct sample addition and identify interfering RF as part of a respiratory viral serologic profile that includes influenza A and B viruses, adenovirus, parainfluenza viruses 1, 2, and 3, and respiratory syncytial virus. Since these controls are not assay specific, they can be incorporated into any serologic multiplex assay.

Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial.

PubMed

Ring, Howard; Gilbert, Nakita; Hook, Roxanne; Platt, Adam; Smith, Christopher; Irvine, Fiona; Donaldson, Cam; Jones, Elizabeth; Kelly, Joanna; Mander, Adrian; Murphy, Caroline; Pennington, Mark; Pullen, Angela; Redley, Marcus; Rowe, Simon; Wason, James

2016-06-24

In adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive clinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe and to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with expertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life outcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also aims to establish whether any perceived benefits represent good value for money. The EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy management versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and drug-resistant epilepsy. Participants are randomly assigned either to a 'treatment as usual' control or a 'defined epilepsy nurse role' active arm, according to the cluster site at which they are treated. The active intervention utilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with ID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention (novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is seizure severity, including associated injuries and the level of distress manifest by the patient in the preceding 4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects. Descriptive measures include demographic and clinical descriptors of participants and clinical services in which they receive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with clinicians and participants' carers are also undertaken. The EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a nurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and epilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting these are discussed. International Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.

Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes.

PubMed

Riddell, M A; Dunbar, J A; Absetz, P; Wolfe, R; Li, H; Brand, M; Aziz, Z; Oldenburg, B

2016-08-24

The 2013 Global Burden of Disease Study demonstrated the increasing burden of diabetes and the challenge it poses to the health systems of all countries. The chronic and complex nature of diabetes requires active self-management by patients in addition to clinical management in order to achieve optimal glycaemic control and appropriate use of available clinical services. This study is an evaluation of a "real world" peer support program aimed at improving the control and management of type 2 diabetes (T2DM) in Australia. The trial used a randomised cluster design with a peer support intervention and routine care control arms and 12-month follow up. Participants in both arms received a standardised session of self-management education at baseline. The intervention program comprised monthly community-based group meetings over 12 months led by trained peer supporters and active encouragement to use primary health care and other community resources and supports related to diabetes. Clinical, behavioural and other measures were collected at baseline, 6 and 12 months. The primary outcome was the predicted 5 year cardiovascular disease risk using the United Kingdom Prospective Diabetes Study (UKPDS) Risk Equation at 12 months. Secondary outcomes included clinical measures, quality of life, measures of support, psychosocial functioning and lifestyle measures. Eleven of 12 planned groups were successfully implemented in the intervention arm. Both the usual care and the intervention arms demonstrated a small reduction in 5 year UKPDS risk and the mean values for biochemical and anthropometric outcomes were close to target at 12 months. There were some small positive changes in self-management behaviours. The positive changes in self-management behaviours among intervention participants were not sufficient to reduce cardiovascular risk, possibly because approximately half of the study participants already had quite well controlled T2DM at baseline. Future research needs to address how to enhance community based programs so that they reach and benefit those most in need of resources and supports to improve metabolic control and associated clinical outcomes. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000469213 . Registered 16 June 2009.

Booster dose vaccination for preventing hepatitis B.

PubMed

Poorolajal, Jalal; Hooshmand, Elham

2016-06-07

Antibodies against hepatitis B surface antigen (HBsAg) wane over time following hepatitis B immunisation; hence, it is unclear whether people vaccinated in three-dose or four-dose schedules of the hepatitis B vaccine are still immune when the hepatitis B surface antibody (anti-HBs) level in their body is undetectable, or lower than the level usually considered protective. This question may potentially be answered indirectly by measuring the anamnestic immune response to a booster dose of vaccine. The term 'booster' (or revaccination) refers to an additional dose of hepatitis B vaccine (HBV) given some time post-primary vaccination to induce immune memory and improve protection against hepatitis B virus (HBV) infection. To assess the benefits and harms of booster dose hepatitis B vaccination, more than five years after the primary vaccination, for preventing HBV infection in healthy individuals previously vaccinated with the hepatitis B vaccine, and with hepatitis B surface antibody (anti-HBs) levels below 10 mIU/mL. We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, conference databases, and reference lists of articles to January 2016. We also contacted authors of articles. In addition, we searched ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing trials (May 2016). Randomised clinical trials addressing anamnestic immune response to a booster dose of hepatitis B vaccine, more than five years after the primary vaccination, in apparently healthy participants, vaccinated in a three-dose or four-dose schedule of the hepatitis B vaccine during the primary vaccination, without receiving an additional dose or immunoglobulin. Both review authors decided if the identified studies met the inclusion criteria or not. Primary outcomes included the proportion of participants with anamnestic immune response in non-protected participants and signs of HBV infection. Secondary outcomes were the proportion of participants that developed local and systemic adverse events following a booster dose injection. We planned to report the weighted proportion with 95% confidence intervals (CIs). There were no eligible randomised clinical trials fulfilling the inclusion criteria of this review. We were unable to include any randomised clinical trials on the topic; only randomised clinical trials will be able to provide an answer as to whether a booster dose vaccination is able to protect against hepatitis B infection.

[Study of continuous quality improvement for clinical laboratory processes via the platform of Hospital Group].

PubMed

Song, Wenqi; Shen, Ying; Peng, Xiaoxia; Tian, Jian; Wang, Hui; Xu, Lili; Nie, Xiaolu; Ni, Xin

2015-05-26

The program of continuous quality improvement in clinical laboratory processes for complete blood count (CBC) was launched via the platform of Beijing Children's Hospital Group in order to improve the quality of pediatric clinical laboratories. Fifteen children's hospitals of Beijing Children's Hospital group were investigated using the method of Chinese adapted continuous quality improvement with PDCA (Plan-Do-Check-Action). The questionnaire survey and inter-laboratory comparison was conducted to find the existing problems, to analyze reasons, to set forth quality targets and to put them into practice. Then, targeted training was conducted to 15 children's hospitals and the second questionnaire survey, self examinations by the clinical laboratories was performed. At the same time, the Group's online internal quality control platform was established. Overall effects of the program were evaluated so that lay a foundation for the next stage of PDCA. Both quality of control system documents and CBC internal quality control scheme for all of clinical laboratories were improved through this program. In addition, standardization of performance verification was also improved, especially with the comparable verification rate of precision and internal laboratory results up to 100%. In terms of instrument calibration and mandatory diagnostic rates, only three out of the 15 hospitals (20%) failed to pass muster in 2014 from 46.67% (seven out of the 15 hospitals) in 2013. The abnormal data of intraday precision variance coefficients of the five CBC indicator parameters (WBC, RBC, Hb, Plt and Hct) of all the 15 laboratories accounted for 1.2% (2/165) in 2014, a marked decrease from 9.6% (14/145) in 2013. While the number of the hospitals using only one horizontal quality control object for daily quality control has dropped to three from five. The 15 hospitals organized a total of 263 times of training in 2014 from 101 times in 2013, up 160%. The quality improvement program for the clinical laboratories launched via the Hospital Group platform can promote the joint development of the pediatric clinical laboratory discipline of all the member hospitals with remarkable improvement results, and the experience is recommendable for further rollout.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

PubMed

Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

2013-10-24

Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Clinical Trials NCT01740635.

A double blind randomised controlled clinical trial comparing a novel anti-stain and calculus reducing dentifrice with a standard fluoride dentifrice.

PubMed

Jowett, Adrian K; Marlow, Ian; Rawlinson, Andrew

2013-04-01

This clinical trial tested the anti-stain efficacy at 3 and 6 months of a novel, sodium polyaspartate-containing, anti-stain dentifrice. In addition, the efficacy of the new dentifrice in controlling gingival inflammation and inhibition of calculus deposition was tested. Participants were recruited to this double blind randomised control clinical trial, and allocated to either test or control groups. The presence of stain and calculus were entry criteria. Measurements of stain, calculus and gingival inflammation were recorded using the Shaw and Murray Stain score, Volpe-Manhold Calculus score and the Modified Gingival Index respectively. Measurements were made at baseline, prior to the removal of stain and calculus, and after 3 and 6 months. Missing data were imputed by and the outcomes were analysed using univariate analysis. At three months, toothpaste containing sodium polyaspartate was better (difference of mean 1.13 with SEM 0.57) than control for the control of dental stain (p<0.05). Stain scores also showed a trend in favour of the test product (difference of mean 1.03 with SEM 0.78) at six months (p>0.05). There was no difference between toothpastes with respect to calculus deposition or gingival inflammation. Toothpaste containing sodium polyaspartate was more effective than a control toothpaste at preventing deposition of dental stain for 3 months after professional tooth cleaning but showed no significant effect at 6 months. Sodium polyaspartate toothpaste was more effective than a control toothpaste at preventing dental stain formation and maybe helpful in controlling staining between episodes of scaling and polishing. Copyright © 2012 Elsevier Ltd. All rights reserved.

Automatic control of pressure support for ventilator weaning in surgical intensive care patients.

PubMed

Schädler, Dirk; Engel, Christoph; Elke, Gunnar; Pulletz, Sven; Haake, Nils; Frerichs, Inéz; Zick, Günther; Scholz, Jens; Weiler, Norbert

2012-03-15

Despite its ability to reduce overall ventilation time, protocol-guided weaning from mechanical ventilation is not routinely used in daily clinical practice. Clinical implementation of weaning protocols could be facilitated by integration of knowledge-based, closed-loop controlled protocols into respirators. To determine whether automated weaning decreases overall ventilation time compared with weaning based on a standardized written protocol in an unselected surgical patient population. In this prospective controlled trial patients ventilated for longer than 9 hours were randomly allocated to receive either weaning with automatic control of pressure support ventilation (automated-weaning group) or weaning based on a standardized written protocol (control group) using the same ventilation mode. The primary end point of the study was overall ventilation time. Overall ventilation time (median [25th and 75th percentile]) did not significantly differ between the automated-weaning (31 [19-101] h; n = 150) and control groups (39 [20-118] h; n = 150; P = 0.178). Patients who underwent cardiac surgery (n = 132) exhibited significantly shorter overall ventilation times in the automated-weaning (24 [18-57] h) than in the control group (35 [20-93] h; P = 0.035). The automated-weaning group exhibited shorter ventilation times until the first spontaneous breathing trial (1 [0-15] vs. 9 [1-51] h; P = 0.001) and a trend toward fewer tracheostomies (17 vs. 28; P = 0.075). Overall ventilation times did not significantly differ between weaning using automatic control of pressure support ventilation and weaning based on a standardized written protocol. Patients after cardiac surgery may benefit from automated weaning. Implementation of additional control variables besides the level of pressure support may further improve automated-weaning systems. Clinical trial registered with www.clinicaltrials.gov (NCT 00445289).

[Implementation of transgingival antibacterial photodynamic therapy (PDT) supplementary to scaling and root planing. A controlled clinical proof-of-principle study].

PubMed

Mettraux, Gérald; Hüsler, Jürg

2011-01-01

The antibacterial photodynamic therapy (PDT) has been effective in the periodontal therapy. The laser light application reported in the literature so far is the subgingival placement of a light fibre. To study the effect of PDT with a transgingival laser application. In 19 patients with untreated periodontitis 1 test and 1 control site were selected. Both pockets were treated by scaling, root planing. the Test site received additional PDT (LASOTRONIC MED 701 by ORCOS MEDICAL, Switzerland) at baseline, after 2 and 6 months. The control sites were rinsed with ringer solution. Clinical parameters (ST, BOP, CAL) and bacterial monitoring (PADO, IAI, Switzerland) at baseline, 2 and 6 months were recorded. Mean pocket reduction was after 6 months 2.1 mm (+/-1.4) in the test group, 1.5 mm (+/-1.6) in the control group significantly different. The 95% confidence interval for the difference of the mean reductions of the test and control group after 6 months is (1.5, 3). Mean CAL gain after 6 months was 1.5 mm (+/-1.3) in the test, 0.9 mm (+/-1.7) in the control group. T. denticola showed lower number after 2 and 6 months in the test versus the control. The total bacterial load (TBL) showed significantly better reduction in the test group at 6 months. The transgingival application of PDT with the MED 701 showed clinical and bacteriological effects which are comparable to those reported in the literature with the subgingival method. The transgingival method is convenient, harmless and easy to perform.

Impact of a Simulated Clinical Day With Peer Coaching and Deliberate Practice: Promoting a Culture of Safety.

PubMed

Badowski, Donna M; Oosterhouse, Kimberly J

Nursing education is challenged to shift from task-based proficiencies to higher level competencies with patient safety as a priority. Using a quasi-experimental pretest/posttest design, a simulation-based, peer-coached, deliberate practice clinical substitution was implemented to compare nursing students' knowledge, skills, and attitudes for promoting safety. Our findings demonstrated improved knowledge and skill acquisition in the intervention and control groups. The former trended toward improved team communication attitudes and enteral medication skill performance. Additional research with larger samples is needed to further investigate this innovative strategy.

[Constraints on publication rights in industry-initiated clinical trials--secondary publication].

PubMed

Gøtzsche, Peter C; Hróbjartsson, Asbjørn; Johansen, Helle Krogh; Haahr, Mette T; Altman, Douglas G; Chan, An-Wen

2006-06-19

In 22 of 44 industry-initiated clinical trial protocols from 1994-95, it was noted that the sponsor either owned the data or needed to approve the manuscript; another 18 protocols had other constraints. Furthermore, in 16 trials, the sponsor had access to accumulating data, and in an additional 16 trials the sponsor could stop the trial at any time, for any reason. These facts were not noted in any of the trial reports. We found similar constraints on publication rights in 44 protocols from 2004. This tight sponsor control over industry-initiated trials should be changed.

[Total artificial heart].

PubMed

Antretter, H; Dumfarth, J; Höfer, D

2015-09-01

To date the CardioWest™ total artificial heart is the only clinically available implantable biventricular mechanical replacement for irreversible cardiac failure. This article presents the indications, contraindications, implantation procedere and postoperative treatment. In addition to a overview of the applications of the total artificial heart this article gives a brief presentation of the two patients treated in our department with the CardioWest™. The clinical course, postoperative rehabilitation, device-related complications and control mechanisms are presented. The total artificial heart is a reliable implant for treating critically ill patients with irreversible cardiogenic shock. A bridge to transplantation is feasible with excellent results.

Influence of Race, Ethnicity and Social Determinants of Health on Diabetes Outcomes.

PubMed

Walker, Rebekah J; Strom Williams, Joni; Egede, Leonard E

2016-04-01

There is strong evidence that race, ethnicity and social determinants of health significantly influence outcomes for patients with diabetes. A better understanding of the mechanisms of these relationships or associations would improve development of cost-effective, culturally tailored programs for patients with diabetes. This article reviews the current state of the literature on the influence of race and ethnicity and social determinants of health on process of care, quality of care and outcomes for diabetes, with particular emphasis on the rural South to give an overview of the state of the literature. The literature review shows that racial or ethnic differences in the clinical outcomes for diabetes, including glycemic, blood pressure (BP) and lipid control, continue to persist. In addition, the literature review shows that the role of social determinants of health on outcomes, and the possible role these determinants play in disparities have largely been ignored. Psychosocial factors, such as self-efficacy, depression, social support and perceived stress, show consistent associations with self-care, quality of life and glycemic control. Neighborhood factors, such as food insecurity, social cohesion and neighborhood esthetics have been associated with glycemic control. Perceived discrimination has also been associated with self-care and the psychological component of quality of life. Healthcare professionals need to be skilled in assessing social determinants of health and taking them into consideration in clinical care. In addition, more research is needed to identify the separate and combined influence of race and ethnicity and social determinants of health on process of care, quality of care and outcomes in diabetes, especially in the South, where the burden of disease is particularly high. Copyright © 2016 Southern Society for Clinical Investigation. All rights reserved.

The Utility of Home-Practice in Mindfulness-Based Group Interventions: A Systematic Review.

PubMed

Lloyd, Annette; White, Ross; Eames, Catrin; Crane, Rebecca

2018-01-01

A growing body of research supports the efficacy of mindfulness-based interventions (MBIs). MBIs consider home-practice as essential to increasing the therapeutic effects of the treatment. To date however, the synthesis of the research conducted on the role of home-practice in controlled MBI studies has been a neglected area. This review aimed to conduct a narrative synthesis of published controlled studies, evaluating mindfulness-based group interventions, which have specifically measured home-practice. Empirical research literature published until June 2016 was searched using five databases. The search strategy focused on mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT), and home-practice. Included studies met the following criteria: controlled trials, participants 18 years and above, evaluations of MBSR or MBCT, utilised standardised quantitative outcome measures and monitored home-practice using a self-reported measure. Fourteen studies met the criteria and were included in the review. Across all studies, there was heterogeneity in the guidance and resources provided to participants and the approaches used for monitoring home-practice. In addition, the guidance on the length of home-practice was variable across studies, which indicates that research studies and teachers are not adhering to the published protocols. Finally, only seven studies examined the relationship between home-practice and clinical outcomes, of which four found that home-practice predicted improvements on clinical outcome measures. Future research should adopt a standardised approach for monitoring home-practice across MBIs. Additionally, studies should assess whether the amount of home-practice recommended to participants is in line with MBSR/MBCT manualised protocols. Finally, research should utilise experimental methodologies to explicitly explore the relationship between home-practice and clinical outcomes.

Continuous glucose monitoring and clinical trials.

PubMed

Heinemann, Lutz

2009-07-01

The use of glucose sensors during clinical trials seems like a great idea at first glance. Continuous glucose monitoring (CGM) should allow the gathering of more detailed information about metabolic control, without requiring much additional effort. In principle, CGM can reduce the duration of such studies and the number of participants required. The aim of this commentary is to highlight some of the reasons why, in practice, at least some of these hopes have not been realized. It is not only that a new technology requires extensive training of the study personnel; the practical handling of the devices and the time and effort required to download and analyze the data are often grossly underestimated initially. In addition, one must select the best endpoints for describing the level of metabolic control in view of the overwhelming amount of information provided by CGM. Several measures and endpoints were proposed as (potential) parameters that would be more meaningful than the standard parameters currently used to describe glucose profiles. Unfortunately, most of these proposed parameters have not, as yet, been proven to be more meaningful. Calibration is another critical aspect of using CGM that must be addressed. How this procedure is handled in practice has a profound impact on the quality of the glucose recordings. Finally, shall the current measurement results be displayed to the study participant or not? CGM can help prevent severe hypoglycemic episodes, but this can profoundly affect the study outcome in a manner that is unrelated to basic aim of the study (e.g., comparing medications that are designed to control glycemia). Therefore, the use of CGM in clinical trials requires much more careful consideration than was initially thought. Copyright 2009 Diabetes Technology Society.

Deficits in agency in schizophrenia, and additional deficits in body image, body schema, and internal timing, in passivity symptoms.

PubMed

Graham, Kyran T; Martin-Iverson, Mathew T; Holmes, Nicholas P; Jablensky, Assen; Waters, Flavie

2014-01-01

Individuals with schizophrenia, particularly those with passivity symptoms, may not feel in control of their actions, believing them to be controlled by external agents. Cognitive operations that contribute to these symptoms may include abnormal processing in agency as well as body representations that deal with body schema and body image. However, these operations in schizophrenia are not fully understood, and the questions of general versus specific deficits in individuals with different symptom profiles remain unanswered. Using the projected-hand illusion (a digital video version of the rubber-hand illusion) with synchronous and asynchronous stroking (500 ms delay), and a hand laterality judgment task, we assessed sense of agency, body image, and body schema in 53 people with clinically stable schizophrenia (with a current, past, and no history of passivity symptoms) and 48 healthy controls. The results revealed a stable trait in schizophrenia with no difference between clinical subgroups (sense of agency) and some quantitative (specific) differences depending on the passivity symptom profile (body image and body schema). Specifically, a reduced sense of self-agency was a common feature of all clinical subgroups. However, subgroup comparisons showed that individuals with passivity symptoms (both current and past) had significantly greater deficits on tasks assessing body image and body schema, relative to the other groups. In addition, patients with current passivity symptoms failed to demonstrate the normal reduction in body illusion typically seen with a 500 ms delay in visual feedback (asynchronous condition), suggesting internal timing problems. Altogether, the results underscore self-abnormalities in schizophrenia, provide evidence for both trait abnormalities and state changes specific to passivity symptoms, and point to a role for internal timing deficits as a mechanistic explanation for external cues becoming a possible source of self-body input.

A cluster randomised controlled trial evaluating the effectiveness and cost-effectiveness of the daily mile on childhood obesity and wellbeing; the Birmingham daily mile protocol.

PubMed

Breheny, Katie; Adab, Peymane; Passmore, Sandra; Martin, James; Lancashire, Emma; Hemming, Karla; Frew, Emma

2018-01-11

Childhood obesity prevention is a public health priority. Children spend a large proportion of their waking time in school; therefore this is an appropriate setting to implement obesity prevention initiatives. Anecdotal reports suggest that implementing The Daily Mile in schools has had positive effects on childhood obesity, academic attainment and wellbeing. This trial aims to measure the effectiveness of The Daily Mile for improving health and wellbeing. This protocol describes a cluster randomised controlled trial (RCT) in 40 primary schools located in Birmingham, UK. Eligible participants are children in years 3 (aged 7-8) and 5 (aged 9-10). The study compares The Daily Mile (intervention) to usual practice (control) in relation to health and wellbeing. The Daily Mile intervention involves an additional 15 min of running or walking integrated into the school day, throughout a 12 month study period. The primary clinical outcome is body mass index (BMI) z-scores at 12 months following introduction of the intervention. The cost per Quality Adjusted Life Year (QALY) is the primary outcome of the economic evaluation. Secondary outcomes include wellbeing, physical fitness and teacher reported academic attainment. This study is the first RCT investigating the clinical and cost-effectiveness of The Daily Mile. A range of outcomes will be measured to evaluate the broader wellbeing and academic benefits in addition to clinical outcomes typically measured in childhood obesity prevention trials. The intervention is simple and low-cost, therefore if the benefits are demonstrated it has enormous potential to influence future policy. ISRCTN: 12698269 . Date protocol registered 27th October 2016.

The effect of vitamin C and/or E supplementations on type 2 diabetic adult males under metformin treatment: A single-blinded randomized controlled clinical trial.

PubMed

El-Aal, Ali Abd; El-Ghffar, Eman A Abd; Ghali, Asmaa Abu; Zughbur, Mohammed R; Sirdah, Mahmoud M

2018-03-16

Recently, there has been an increasing interest in the influence of antioxidant vitamins on the efficacy of oral hypoglycemic therapy in type 2 diabetic patients (T2DM). This single-blinded randomized controlled clinical trial aimed to investigate the effect of vitamin C and/or E supplementation on the efficacy of oral hypoglycemic therapy in T2DM Palestinian male patients from the Gaza Strip. Forty T2DM male patients aged 40-60 years on metformin treatment were randomly divided into four groups, each group received an additional one of the following daily oral supplements for 90 days: placebo; vitamin C; vitamin E and vitamin C plus vitamin E. After overnight fasting, venous blood specimens were collected from all individuals into K3-EDTA tubes and serum tubes for measuring the biochemical and hematological parameters of the study at baseline and after 90 days of vitamins supplementation. The results revealed that vitamin C and/or E improve fasting blood sugar (FBS), HbA1c, lipid profile, insulin, homeostasis model assessment of insulin resistance (HOMA-IR), reduced glutathione (GSH); and Quantitative Insulin Sensitivity Check Index (QISCI) compared with diabetic patients group that received placebo. This study provided additional evidence on the beneficial effects of supplementing antioxidant vitamins in T2DM which could improve the clinical condition and attenuate or prevent diabetic pathogenesis and complications that, secondly to poor glycemic control, could attribute to the imbalance between the decline in the endogenous antioxidants and increasing production of the reactive oxygen species leading to the oxidant-mediated damage present in the diabetic context. Copyright © 2018 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Nanoparticle Enhancement Cascade for Sensitive Multiplex Measurements of Biomarkers in Complex Fluids with Surface Plasmon Resonance Imaging.

PubMed

Hendriks, Jan; Stojanovic, Ivan; Schasfoort, Richard B M; Saris, Daniël B F; Karperien, Marcel

2018-06-05

There is a large unmet need for reliable biomarker measurement systems for clinical application. Such systems should meet challenging requirements for large scale use, including a large dynamic detection range, multiplexing capacity, and both high specificity and sensitivity. More importantly, these requirements need to apply to complex biological samples, which require extensive quality control. In this paper, we present the development of an enhancement detection cascade for surface plasmon resonance imaging (SPRi). The cascade applies an antibody sandwich assay, followed by neutravidin and a gold nanoparticle enhancement for quantitative biomarker measurements in small volumes of complex fluids. We present a feasibility study both in simple buffers and in spiked equine synovial fluid with four cytokines, IL-1β, IL-6, IFN-γ, and TNF-α. Our enhancement cascade leads to an antibody dependent improvement in sensitivity up to 40 000 times, resulting in a limit of detection as low as 50 fg/mL and a dynamic detection range of more than 7 logs. Additionally, measurements at these low concentrations are highly reliable with intra- and interassay CVs between 2% and 20%. We subsequently showed this assay is suitable for multiplex measurements with good specificity and limited cross-reactivity. Moreover, we demonstrated robust detection of IL-6 and IL-1β in spiked undiluted equine synovial fluid with small variation compared to buffer controls. In addition, the availability of real time measurements provides extensive quality control opportunities, essential for clinical applications. Therefore, we consider this method is suitable for broad application in SPRi for multiplex biomarker detection in both research and clinical settings.

[Treatment of fibromyalgia syndrome with gamma-hydroxybutyrate : A randomized controlled study].

PubMed

Reuter, E; Tafelski, S; Thieme, K; West, C; Haase, U; Beck, L; Schäfer, M; Spies, C

2017-04-01

The etiology of fibromyalgia syndrome is not yet fully understood. Current hypotheses suggest a potential role of gamma-hydroxybutyrate (GHB) in influencing endocrinological abnormalities in patients with fibromyalgia. The aim of the study was to investigate whether low dose GHB as a growth-hormone releasing substance reduces pain intensity and improves depressive mood, physical impairment and sleep quality in outpatients with fibromyalgia. Additionally, adverse events were recorded. The pilot study was conducted in the outpatient clinic for pain at the clinic for anesthesiology and surgical intensive care of the Charité Universitätsmedizin Berlin. In the study 25 female patients with fibromyalgia according to the criteria of the American College of Rheumatology were randomized into 2 groups. Over 15 weeks patients of the intervention group received 25 mg/kg body weight oral GHB before going to bed and were compared with a placebo control group. In addition, all patients participated in operant behavioral pain treatment in a group setting. Dependent variables were pain intensity, depressive mood, physical impairment and quality of sleep. There were no group differences in the course of pain intensity (p = 0.61), depressive mood (p = 0.16), physical impairment (p = 0.25) and quality of sleep (p = 0.44); however, all symptoms improved across the groups from pretherapy to posttherapy. Low dose GHB did not increase growth hormone blood concentrations. The number of adverse events that were reported more than two times was similar in both groups. Administration of low dose GHB did not yield clinical improvements in female outpatients with fibromyalgia. General improvement in the course of treatment may have resulted from operant behavioral pain therapy. Future studies on GHB should control hypothetical risk factors for identification of non-responders.

Phonological and Articulation Treatment Approaches in Portuguese Children with Speech and Language Impairments: A Randomized Controlled Intervention Study

ERIC Educational Resources Information Center

Lousada, M.; Jesus, Luis M. T.; Capelas, S.; Margaca, C.; Simoes, D.; Valente, A.; Hall, A.; Joffe, V. L.

2013-01-01

Background: In Portugal, the routine clinical practice of speech and language therapists (SLTs) in treating children with all types of speech sound disorder (SSD) continues to be articulation therapy (AT). There is limited use of phonological therapy (PT) or phonological awareness training in Portugal. Additionally, at an international level there…

Additive enhancement of wound healing in diabetic mice by low level light and topical CoQ10.

PubMed

Mao, Zhigang; Wu, Jeffrey H; Dong, Tingting; Wu, Mei X

2016-02-02

Diabetes, a highly prevalent disease that affects 9.3% of Americans, often leads to severe complications and slow wound healing. Preclinical studies have suggested that low level light therapy (LLLT) can accelerate wound healing in diabetic subjects, but significant improvements must be made to overcome the absence of persuasive evidence for its clinical use. We demonstrate here that LLLT can be combined with topical Coenzyme Q10 (CoQ10) to heal wounds in diabetic mice significantly faster than LLLT alone, CoQ10 alone, or controls. LLLT followed by topical CoQ10 enhanced wound healing by 68~103% in diabetic mice in the first week and more than 24% in the second week compared with untreated controls. All wounds were fully healed in two weeks following the dual treatment, in contrast to only 50% wounds or a fewer being fully healed for single or sham treatment. The accelerated healing was corroborated by at least 50% higher hydroxyproline levels, and tripling cell proliferation rates in LLLT and CoQ10 treated wounds over controls. The beneficial effects on wound healing were probably attributed to additive enhancement of ATP production by LLLT and CoQ10 treatment. The combination of LLLT and topical CoQ10 is safe and convenient, and merits further clinical study.

[Efficacy of HRV-biofeedback as additional treatment of depression and PTSD].

PubMed

Blase, K L; van Dijke, A; Cluitmans, P J M; Vermetten, E

2016-01-01

Heartrate variability biofeedback (HRVB) is a non-invasive treatment in which patients are assumed to self-regulate a physiological dysregulated vagal nerve. Although the therapeutic approach of HRVB is promising in various stress-related disorders, it has only been offered on a regular basis in a few mental health treatment settings. To analyse the efficacy of HRV biofeedback as an additional psychophysiological treatment for depression and PTSD. Systematic review with search terms HRV, biofeedback, PTSD, depression, panic disorder and anxiety disorder. Our search of the literature yielded 789 studies. After critical appraisal using the GRADE method, we selected 6 randomised controlled trials (RCTs) and 4 relevant studies. The RCTs with control groups 'treatment as usual' and muscle relaxation training revealed significant clinical efficacy and better results than control conditions after 4 to 8 weeks training. Although this systematic review shows the popularity of HRV in literature, it does not indicate that HRVB really has been reviewed systematically. Significant outcomes of this limited number of randomised studies indicate there may be a clinical improvement when HRVB training is integrated into treatment of PTSD and depression, particularly when this integration procedure is combined with psychotherapy. More research needs to be done with larger groups and further efforts are needed to integrate HRVB into treatment of stress-related disorders in psychiatry. Future research also needs to focus on the psychophysiological mechanisms involved.

Additive enhancement of wound healing in diabetic mice by low level light and topical CoQ10

NASA Astrophysics Data System (ADS)

Mao, Zhigang; Wu, Jeffrey H.; Dong, Tingting; Wu, Mei X.

2016-02-01

Diabetes, a highly prevalent disease that affects 9.3% of Americans, often leads to severe complications and slow wound healing. Preclinical studies have suggested that low level light therapy (LLLT) can accelerate wound healing in diabetic subjects, but significant improvements must be made to overcome the absence of persuasive evidence for its clinical use. We demonstrate here that LLLT can be combined with topical Coenzyme Q10 (CoQ10) to heal wounds in diabetic mice significantly faster than LLLT alone, CoQ10 alone, or controls. LLLT followed by topical CoQ10 enhanced wound healing by 68~103% in diabetic mice in the first week and more than 24% in the second week compared with untreated controls. All wounds were fully healed in two weeks following the dual treatment, in contrast to only 50% wounds or a fewer being fully healed for single or sham treatment. The accelerated healing was corroborated by at least 50% higher hydroxyproline levels, and tripling cell proliferation rates in LLLT and CoQ10 treated wounds over controls. The beneficial effects on wound healing were probably attributed to additive enhancement of ATP production by LLLT and CoQ10 treatment. The combination of LLLT and topical CoQ10 is safe and convenient, and merits further clinical study.

Additive enhancement of wound healing in diabetic mice by low level light and topical CoQ10

PubMed Central

Mao, Zhigang; Wu, Jeffrey H.; Dong, Tingting; Wu, Mei X.

2016-01-01

Diabetes, a highly prevalent disease that affects 9.3% of Americans, often leads to severe complications and slow wound healing. Preclinical studies have suggested that low level light therapy (LLLT) can accelerate wound healing in diabetic subjects, but significant improvements must be made to overcome the absence of persuasive evidence for its clinical use. We demonstrate here that LLLT can be combined with topical Coenzyme Q10 (CoQ10) to heal wounds in diabetic mice significantly faster than LLLT alone, CoQ10 alone, or controls. LLLT followed by topical CoQ10 enhanced wound healing by 68~103% in diabetic mice in the first week and more than 24% in the second week compared with untreated controls. All wounds were fully healed in two weeks following the dual treatment, in contrast to only 50% wounds or a fewer being fully healed for single or sham treatment. The accelerated healing was corroborated by at least 50% higher hydroxyproline levels, and tripling cell proliferation rates in LLLT and CoQ10 treated wounds over controls. The beneficial effects on wound healing were probably attributed to additive enhancement of ATP production by LLLT and CoQ10 treatment. The combination of LLLT and topical CoQ10 is safe and convenient, and merits further clinical study. PMID:26830658

Comparison of four different techniques to evaluate the elastic properties of phantom in elastography: is there a gold standard?

NASA Astrophysics Data System (ADS)

Oudry, Jennifer; Lynch, Ted; Vappou, Jonathan; Sandrin, Laurent; Miette, Véronique

2014-10-01

Elastographic techniques used in addition to imaging techniques (ultrasound, resonance magnetic or optical) provide new clinical information on the pathological state of soft tissues. However, system-dependent variation in elastographic measurements may limit the clinical utility of these measurements by introducing uncertainty into the measurement. This work is aimed at showing differences in the evaluation of the elastic properties of phantoms performed by four different techniques: quasi-static compression, dynamic mechanical analysis, vibration-controlled transient elastography and hyper-frequency viscoelastic spectroscopy. Four Zerdine® gel materials were tested and formulated to yield a Young’s modulus over the range of normal and cirrhotic liver stiffnesses. The Young’s modulus and the shear wave speed obtained with each technique were compared. Results suggest a bias in elastic property measurement which varies with systems and highlight the difficulty in finding a reference method to determine and assess the elastic properties of tissue-mimicking materials. Additional studies are needed to determine the source of this variation, and control for them so that accurate, reproducible reference standards can be made for the absolute measurement of soft tissue elasticity.

Comparison of four different techniques to evaluate the elastic properties of phantom in elastography: is there a gold standard?

PubMed

Oudry, Jennifer; Lynch, Ted; Vappou, Jonathan; Sandrin, Laurent; Miette, Véronique

2014-10-07

Elastographic techniques used in addition to imaging techniques (ultrasound, resonance magnetic or optical) provide new clinical information on the pathological state of soft tissues. However, system-dependent variation in elastographic measurements may limit the clinical utility of these measurements by introducing uncertainty into the measurement. This work is aimed at showing differences in the evaluation of the elastic properties of phantoms performed by four different techniques: quasi-static compression, dynamic mechanical analysis, vibration-controlled transient elastography and hyper-frequency viscoelastic spectroscopy. Four Zerdine® gel materials were tested and formulated to yield a Young's modulus over the range of normal and cirrhotic liver stiffnesses. The Young's modulus and the shear wave speed obtained with each technique were compared. Results suggest a bias in elastic property measurement which varies with systems and highlight the difficulty in finding a reference method to determine and assess the elastic properties of tissue-mimicking materials. Additional studies are needed to determine the source of this variation, and control for them so that accurate, reproducible reference standards can be made for the absolute measurement of soft tissue elasticity.

[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.

Laboratory cost control and financial management software.

PubMed

Mayer, M

1998-02-09

Economical constraints within the health care system advocate the introduction of tighter control of costs in clinical laboratories. Detailed cost information forms the basis for cost control and financial management. Based on the cost information, proper decisions regarding priorities, procedure choices, personnel policies and investments can be made. This presentation outlines some principles of cost analysis, describes common limitations of cost analysis, and exemplifies use of software to achieve optimized cost control. One commercially available cost analysis software, LabCost, is described in some detail. In addition to provision of cost information, LabCost also serves as a general management tool for resource handling, accounting, inventory management and billing. The application of LabCost in the selection process of a new high throughput analyzer for a large clinical chemistry service is taken as an example for decisions that can be assisted by cost evaluation. It is concluded that laboratory management that wisely utilizes cost analysis to support the decision-making process will undoubtedly have a clear advantage over those laboratories that fail to employ cost considerations to guide their actions.

Correlation between Apgar score and urinary uric acid to creatinine ratio in perinatal asphyxia.

PubMed

Basu, Pallab; Som, Sabyasachi; Choudhuri, Nabendu; Das, Harendranath

2008-10-01

A randomized case control hospital based study was conducted over 12 months time on 31 asphyxiated and 31 normal newborn to see whether urinary uric acid can be used as a marker of perinatal asphyxia and can be correlated with the clinical diagnosis by Apgar score. Uric acid and creatinine were estimated in spot urine within 24 hours after birth in both cases and controls. A ratio between concentrations of uric acid to creatinine was estimated and compared between cases and controls. It was found that the ratios were significantly higher in cases than controls (3.1± 1.3 vs 0.96± 0.54; P < 0.001) and among asphyxia patients, a significant negative linear correlation was found between the uric acid to creatinine ratio and the Apgar score (r = -0.857, P < 0.001). So urinary uric acid to creatinine ratio can be used as an additional non-invasive dispace, easy and at the same time early biochemical marker of birth asphyxia which biochemically supports the clinical diagnosis and severity grading of asphyxia by Apgar score.

Postural control in subclinical neck pain: a comparative study on the effect of pain and measurement procedures.

PubMed

Amaral, Gabriela; Martins, Helena; Silva, Anabela G

2018-04-25

This study investigated whether young university students with neck pain (NP) have postural control deficits when compared to sex and age-matched asymptomatic subjects. Centre of pressure (COP) sway area, velocity, anterior-posterior and mediolateral distances were measured in participants with (n=27) and without (n=27) neck pain for different combinations of static standing (narrow stance, tandem stance and single leg stance) and measurement time (90, 60, 30 and 15 s) with eyes closed using a force plate. Additionally, static and dynamic clinical tests of postural control were used. No significant between group differences were found for the COP measurements (p>0.05). However, individuals with subclinical NP were more likely to fail the 90 s tandem test (p<0.05) in the force plate and univariate comparisons revealed significant between group differences in the tandem and single leg stance clinical test measurements. Taken together, the inconsistent results might suggest an emerging postural control deficit in university students with low disability and low intensity chronic idiopathic NP.

Enhancing CBT for Chronic Insomnia: A Randomised Clinical Trial of Additive Components of Mindfulness or Cognitive Therapy.

PubMed

Wong, Mei Yin; Ree, Melissa J; Lee, Christopher W

2016-09-01

Although cognitive behavioural therapy (CBT) for insomnia has resulted in significant reductions in symptoms, most patients are not classified as good sleepers after treatment. The present study investigated whether additional sessions of cognitive therapy (CT) or mindfulness-based therapy (MBT) could enhance CBT in 64 participants with primary insomnia. All participants were given four sessions of standard CBT as previous research had identified this number of sessions as an optimal balance between therapist guidance and patient independence. Participants were then allocated to further active treatment (four sessions of CT or MBT) or a no further treatment control. The additional treatments resulted in significant improvements beyond CBT on self-report and objective measures of sleep and were well tolerated as evidenced by no dropouts from either treatment. The effect sizes for each of these additional treatments were large and clinically significant. The mean scores on the primary outcome measure, the Insomnia Severity Index, were 5.74 for CT and 6.69 for MBT, which are within the good-sleeper range. Treatment effects were maintained at follow-up. There were no significant differences between CT and MBT on any outcome measure. These results provide encouraging data on how to enhance CBT for treatment of insomnia. Copyright © 2015 John Wiley & Sons, Ltd. CBT treatments for insomnia can be enhanced using recent developments in cognitive therapy. CBT treatments for insomnia can be enhanced using mindfulness-based treatments. Both cognitive therapy and mindfulness produce additional clinically significant change. Copyright © 2015 John Wiley & Sons, Ltd.

Early Life Stress and Sleep Restriction as Risk Factors in PTSD: An Integrative Pre-Clinical Approach

DTIC Science & Technology

2015-04-01

dDG GABAAR alpha 1 expression in both J+UWT(+),EE (J) and EE (A) rats compered to Control. In addition, EE (A) rats exhibit lower expression of BLA...GABAAR alpha 1 expression compered to Control. (*= pɘ.05,**= pɘ.01). 48 7: One way ANOVA [F (3,47)= 4.79, pɘ.01] revealed a significant main...effect for the exposure. Further Post hoc comparisons revealed increased vDG GABAAR alpha 1 expression in both J+UWT(+) and EE (A) rats compered to EE (J

Bionic models for identification of biological systems

NASA Astrophysics Data System (ADS)

Gerget, O. M.

2017-01-01

This article proposes a clinical decision support system that processes biomedical data. For this purpose a bionic model has been designed based on neural networks, genetic algorithms and immune systems. The developed system has been tested on data from pregnant women. The paper focuses on the approach to enable selection of control actions that can minimize the risk of adverse outcome. The control actions (hyperparameters of a new type) are further used as an additional input signal. Its values are defined by a hyperparameter optimization method. A software developed with Python is briefly described.

Does Extracellular DNA Production Vary in Staphylococcal Biofilms Isolated From Infected Implants versus Controls?

PubMed

Zatorska, Beata; Groger, Marion; Moser, Doris; Diab-Elschahawi, Magda; Lusignani, Luigi Segagni; Presterl, Elisabeth

2017-08-01

Prosthetic implant infections caused by Staphylococcus aureus and epidermidis are major challenges for early diagnosis and treatment owing to biofilm formation on the implant surface. Extracellular DNA (eDNA) is actively excreted from bacterial cells in biofilms, contributing to biofilm stability, and may offer promise in the detection or treatment of such infections. (1) Does DNA structure change during biofilm formation? (2) Are there time-dependent differences in eDNA production during biofilm formation? (3) Is there differential eDNA production between clinical and control Staphylococcal isolates? (4) Is eDNA production correlated to biofilm thickness? We investigated eDNA presence during biofilm formation in 60 clinical and 30 control isolates of S aureus and S epidermidis. The clinical isolates were isolated from patients with infections of orthopaedic prostheses and implants: 30 from infected hip prostheses and 30 from infected knee prostheses. The control isolates were taken from healthy volunteers who had not been exposed to antibiotics and a hospital environment during the previous 3 and 12 months, respectively. Control S epidermidis was isolated from the skin of the antecubital fossa, and control S aureus was isolated from the nares. For the biofilm experiments the following methods were used to detect eDNA: (1) fluorescent staining with 4',6-diamidino-2-phenylindole (DAPI), (2) eDNA extraction using a commercial kit, and (3) confocal laser scanning microscopy for 24-hour biofilm observation using propidium iodide and concanavalin-A staining; TOTO ® -1 and SYTO ® 60 staining were used for observation and quantification of eDNA after 6 and 24 hours of biofilm formation. Additionally antibiotic resistance was described. eDNA production as observed by confocal laser scanning microscopy was greater in clinical isolates than controls (clinical isolates mean ± SD: 1.84% ± 1.31%; control mean ± SD: 1.17% ± 1.37%; p < 0.005) after 6 hours of biofilm formation. After 24 hours, the amount of eDNA was greater in biofilms of S epidermidis than in biofilms of S aureus (S aureus mean ± SD: 1.35% ± 2.0%; S epidermidis mean ± SD: 6.42% ± 10.6%; p < 0.05). Clinical isolates of S aureus and S epidermidis produced more eDNA than control isolates at 6 hours of biofilm formation. The extraction method also showed that clinical isolates produced substantially greater amounts of eDNA than controls. S aureus and S epidermidis exhibit a differential production of DNA with time. Clinical isolates associated with implant infections produce greater amounts of eDNA than controls. Future research might focus on the diagnostic value of eDNA as a surrogate laboratory marker for biofilm formation in implant infections. eDNA should be considered as a potential future diagnostic tool or even a possible target to modify biofilms for successful treatment of biofilm-associated infections.

Association between reading speed, cycloplegic refractive error, and oculomotor function in reading disabled children versus controls.

PubMed

Quaid, Patrick; Simpson, Trefford

2013-01-01

Approximately one in ten students aged 6 to 16 in Ontario (Canada) school boards have an individual education plan (IEP) in place due to various learning disabilities, many of which are specific to reading difficulties. The relationship between reading (specifically objectively determined reading speed and eye movement data), refractive error, and binocular vision related clinical measurements remain elusive. One hundred patients were examined in this study (50 IEP and 50 controls, age range 6 to 16 years). IEP patients were referred by three local school boards, with controls being recruited from the routine clinic population (non-IEP patients in the same age group). A comprehensive eye examination was performed on all subjects, in addition to a full binocular vision work-up and cycloplegic refraction. In addition to the cycloplegic refractive error, the following binocular vision related data was also acquired: vergence facility, vergence amplitudes, accommodative facility, accommodative amplitudes, near point of convergence, stereopsis, and a standardized symptom scoring scale. Both the IEP and control groups were also examined using the Visagraph III system, which permits recording of the following reading parameters objectively: (i) reading speed, both raw values and values compared to grade normative data, and (ii) the number of eye movements made per 100 words read. Comprehension was assessed via a questionnaire administered at the end of the reading task, with each subject requiring 80% or greater comprehension. The IEP group had significantly greater hyperopia compared to the control group on cycloplegic examination. Vergence facility was significantly correlated to (i) reading speed, (ii) number of eye movements made when reading, and (iii) a standardized symptom scoring system. Vergence facility was also significantly reduced in the IEP group versus controls. Significant differences in several other binocular vision related scores were also found. This research indicates there are significant associations between reading speed, refractive error, and in particular vergence facility. It appears sensible that students being considered for reading specific IEP status should have a full eye examination (including cycloplegia), in addition to a comprehensive binocular vision evaluation.

Improving blood pressure control in diabetes: limitations of a clinical reminder in influencing physician behavior.

PubMed

Sanders, Karen M; Satyvavolu, Anuradha

2002-01-01

Hypertension should be aggressively treated, especially in diabetic patients. But studies of physician prescribing habits reveal that physicians often delay making medication changes or initiating antihypertensive therapy. A chart-based reminder was designed to improve physician medication prescribing in this clinical situation. A randomized controlled trial was conducted at the Veterans Affairs Medical Center in Richmond, Virginia. Patients with diabetes and hypertension were selected. A highly visible chart reminder was applied to the front of outpatient charts in the intervention group practice. A chart review was conducted to assess physician-directed medication changes. A successful outcome was defined as any antihypertensive medication increase or addition at that same visit. Physicians were more likely to intensify antihypertensive medication as the blood pressure increased regardless of the reminder. Overall, only 33% of visits resulted in a medication change, even though 93% of patients had elevations over target blood pressure at the follow-up visit. Physicians in the intervention and control groups made changes to medication at similar rates (chi 2 = 0.621, p = .511). In this study, a chart reminder failed to improve physician compliance with the clinical guideline for hypertension management in diabetics, Sixth Report of the Joint National Committee on the Detection, Evaluation, Prevention and Treatment of High Blood Pressure. To inform the design of effective intervention strategies, further research should explore specific barriers to guideline adherence in this clinical situation.

Clinical (but not cognitive) recovery in schizophrenia through the experience of fictional cinema.

PubMed

Peña, J; Sánchez, P; Elizagárate, E; Ibarretxe-Bilbao, N; Ezcurra, J; Caballero, L; Magariños, M; García Del Castillo, I; Gutiérrez, M; Ojeda, N

2015-12-01

One of the criticisms of rehabilitation techniques is their limited application to the patient's daily life. In the past, cinema has been used as a psychiatric rehabilitation tool, with the primary objective of facilitating training in social abilities and communication. In this study, we consider the use of film not only as a clinical recovery tool but also as a novel cognitive recovery tool for additional rehabilitation not only for communication and social abilities but also for all of the basic cognitive and social cognition processes. In this randomized clinical trial, 48 patients with schizophrenia were assigned to an experimental or control group. Both of the groups received treatment sessions that included viewing episodes of the television series The Sopranos . Next, the experimental group participated in a structured cognitive training session that featured questions and exercises based on the episodes. The control group participated in an idea-sharing session (of the same duration and frequency) about what the group members saw in the episode. At the end of the treatment, both the positive and negative clinical symptoms of the experimental group improved significantly compared with the control group. However, this improvement was not observed in basic or social cognitive functions. A brief intervention based on transforming the activities of daily life can be an effective tool for psychiatric rehabilitation. However, the study's current characteristics and sample did not produce benefits in cognitive parameters.

Mental and somatic health in a non-clinical sample 10 years after a diagnosis of encopresis.

PubMed

Hultén, Ib; Jonsson, Jakob; Jonsson, Carl-Otto

2005-12-01

The aim of this study was to assess the relation between the diagnosis of encopresis at 8 and 10 years of age, and mental and somatic health 10 years later. The importance of type of encopresis (primary or secondary) at 8 years was also studied. Subjects were a non-clinical encopretic sample (N=73) and control subjects (N=75) [2]. Seven assessment variables from conscription surveys provided information about mental and somatic health status at 18 years of age. Former encopretics (n=66) did not differ significantly from the controls (n=67) at 18 years of age, although there were consistent, small negative differences. The boys who at 10 years of age had still been encopretic did not differ significantly at 18 years of age from the boys who at 10 years had recovered from encopresis, and the signs indicating the small differences varied. For former primary and secondary encopretic boys, there were two significant differences, the men in the secondary group being more often exempted from conscription than the primary group and the control cases. The results indicate that boys with non-clinical encopresis show only small, if any, mental and somatic disturbances at the beginning of adulthood. Comprehensive investigations of encopretic patients are recommended as important clinical problems, in addition to encopresis, might be present.

The association of cognitive impairment with gray matter atrophy and cortical lesion load in clinically isolated syndrome.

PubMed

Diker, Sevda; Has, Arzu Ceylan; Kurne, Aslı; Göçmen, Rahşan; Oğuz, Kader Karlı; Karabudak, Rana

2016-11-01

Multiple sclerosis can impair cognition from the early stages and has been shown to be associated with gray matter damage in addition to white matter pathology. To investigate the profile of cognitive impairment in clinically isolated syndrome (CIS), and the contribution of cortical inflammation, cortical and deep gray matter atrophy, and white matter lesions to cognitive decline. Thirty patients with clinically isolated syndrome and twenty demographically- matched healthy controls underwent neuropsychologic assessment through the Rao Brief Repeatable Battery, and brain magnetic resonance imaging with double inversion recovery using a 3T scanner. Patients with clinically isolated syndrome performed significantly worse than healthy controls on tests that evaluated verbal memory, visuospatial learning and memory, and verbal fluency. Significant deep gray matter atrophy was found in the patients but cortical volume was not lower than the controls. Visual memory tests correlated with the volume of the hippocampus, cerebral white matter and deep gray matter structures and with cerebellar cortical atrophy. Cortical or white matter lesion load did not affect cognitive test results. In our patients with CIS, it was shown that cognitive impairment was mainly related to cerebral white matter, cerebellar cortical and deep gray matter atrophy, but not with cortical inflammation, at least in the early stage of disease. Copyright © 2016 Elsevier B.V. All rights reserved.

Digital subtraction radiographic analysis of the combination of bioabsorbable membrane and bovine morphogenetic protein pool in human periodontal infrabony defects

PubMed Central

GUIMARÃES, Maria do Carmo Machado; PASSANEZI, Euloir; SANT’ANA, Adriana Campos Passanezi; GREGHI, Sebastião Luiz Aguiar; TABA JUNIOR, Mario

2010-01-01

Objectives This study assessed the bone density gain and its relationship with the periodontal clinical parameters in a case series of a regenerative therapy procedure. Material and Methods Using a split-mouth study design, 10 pairs of infrabony defects from 15 patients were treated with a pool of bovine bone morphogenetic proteins associated with collagen membrane (test sites) or collagen membrane only (control sites). The periodontal healing was clinically and radiographically monitored for six months. Standardized presurgical and 6-month postoperative radiographs were digitized for digital subtraction analysis, which showed relative bone density gain in both groups of 0.034 ± 0.423 and 0.105 ± 0.423 in the test and control group, respectively (p>0.05). Results As regards the area size of bone density change, the influence of the therapy was detected in 2.5 mm2 in the test group and 2 mm2 in the control group (p>0.05). Additionally, no correlation was observed between the favorable clinical results and the bone density gain measured by digital subtraction radiography (p>0.05). Conclusions The findings of this study suggest that the clinical benefit of the regenerative therapy observed did not come with significant bone density gains. Long-term evaluation may lead to a different conclusions. PMID:20835573

Randomized clinical trial of bright light therapy for antepartum depression: preliminary findings.

PubMed

Epperson, C Neill; Terman, Michael; Terman, Jiuan Su; Hanusa, Barbara H; Oren, Dan A; Peindl, Kathleen S; Wisner, Katherine L

2004-03-01

Bright light therapy was shown to be a promising treatment for depression during pregnancy in a recent open-label study. In an extension of this work, we report findings from a double-blind placebo-controlled pilot study. Ten pregnant women with DSM-IV major depressive disorder were randomly assigned from April 2000 to January 2002 to a 5-week clinical trial with either a 7000 lux (active) or 500 lux (placebo) light box. At the end of the randomized controlled trial, subjects had the option of continuing in a 5-week extension phase. The Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder Version was administered to assess changes in clinical status. Salivary melatonin was used to index circadian rhythm phase for comparison with antidepressant results. Although there was a small mean group advantage of active treatment throughout the randomized controlled trial, it was not statistically significant. However, in the longer 10-week trial, the presence of active versus placebo light produced a clear treatment effect (p =.001) with an effect size (0.43) similar to that seen in antidepressant drug trials. Successful treatment with bright light was associated with phase advances of the melatonin rhythm. These findings provide additional evidence for an active effect of bright light therapy for antepartum depression and underscore the need for an expanded randomized clinical trial.

Genome-wide association study of clinically defined gout identifies multiple risk loci and its association with clinical subtypes

PubMed Central

Matsuo, Hirotaka; Yamamoto, Ken; Nakaoka, Hirofumi; Nakayama, Akiyoshi; Sakiyama, Masayuki; Chiba, Toshinori; Takahashi, Atsushi; Nakamura, Takahiro; Nakashima, Hiroshi; Takada, Yuzo; Danjoh, Inaho; Shimizu, Seiko; Abe, Junko; Kawamura, Yusuke; Terashige, Sho; Ogata, Hiraku; Tatsukawa, Seishiro; Yin, Guang; Okada, Rieko; Morita, Emi; Naito, Mariko; Tokumasu, Atsumi; Onoue, Hiroyuki; Iwaya, Keiichi; Ito, Toshimitsu; Takada, Tappei; Inoue, Katsuhisa; Kato, Yukio; Nakamura, Yukio; Sakurai, Yutaka; Suzuki, Hiroshi; Kanai, Yoshikatsu; Hosoya, Tatsuo; Hamajima, Nobuyuki; Inoue, Ituro; Kubo, Michiaki; Ichida, Kimiyoshi; Ooyama, Hiroshi; Shimizu, Toru; Shinomiya, Nariyoshi

2016-01-01

Objective Gout, caused by hyperuricaemia, is a multifactorial disease. Although genome-wide association studies (GWASs) of gout have been reported, they included self-reported gout cases in which clinical information was insufficient. Therefore, the relationship between genetic variation and clinical subtypes of gout remains unclear. Here, we first performed a GWAS of clinically defined gout cases only. Methods A GWAS was conducted with 945 patients with clinically defined gout and 1213 controls in a Japanese male population, followed by replication study of 1048 clinically defined cases and 1334 controls. Results Five gout susceptibility loci were identified at the genome-wide significance level (p<5.0×10−8), which contained well-known urate transporter genes (ABCG2 and SLC2A9) and additional genes: rs1260326 (p=1.9×10−12; OR=1.36) of GCKR (a gene for glucose and lipid metabolism), rs2188380 (p=1.6×10−23; OR=1.75) of MYL2-CUX2 (genes associated with cholesterol and diabetes mellitus) and rs4073582 (p=6.4×10−9; OR=1.66) of CNIH-2 (a gene for regulation of glutamate signalling). The latter two are identified as novel gout loci. Furthermore, among the identified single-nucleotide polymorphisms (SNPs), we demonstrated that the SNPs of ABCG2 and SLC2A9 were differentially associated with types of gout and clinical parameters underlying specific subtypes (renal underexcretion type and renal overload type). The effect of the risk allele of each SNP on clinical parameters showed significant linear relationships with the ratio of the case–control ORs for two distinct types of gout (r=0.96 [p=4.8×10−4] for urate clearance and r=0.96 [p=5.0×10−4] for urinary urate excretion). Conclusions Our findings provide clues to better understand the pathogenesis of gout and will be useful for development of companion diagnostics. PMID:25646370

Preoperative MRI and surgical management in patients with nonpalpable breast cancer: the MONET - randomised controlled trial.

PubMed

Peters, N H G M; van Esser, S; van den Bosch, M A A J; Storm, R K; Plaisier, P W; van Dalen, T; Diepstraten, S C E; Weits, T; Westenend, P J; Stapper, G; Fernandez-Gallardo, M A; Borel Rinkes, I H M; van Hillegersberg, R; Mali, W P Th M; Peeters, P H M

2011-04-01

We evaluated whether performing contrast-enhanced breast MRI in addition to mammography and/or ultrasound in patients with nonpalpable suspicious breast lesions improves breast cancer management. The MONET - study (MR mammography of nonpalpable breast tumours) is a randomised controlled trial in patients with a nonpalpable BIRADS 3-5 lesion. Patients were randomly assigned to receive routine medical care, including mammography, ultrasound and lesion sampling by large core needle biopsy or additional MRI preceding biopsy. Patients with cancer were referred for surgery. Primary end-point was the rate of additional surgical procedures (re-excisions and conversion to mastectomy) in patients with a nonpalpable breast cancer. Four hundred and eighteen patients were randomised, 207 patients were allocated to MRI, and 211 patients to the control group. In the MRI group 74 patients had 83 malignant lesions, compared to 75 patients with 80 malignant lesions in the control group. The primary breast conserving surgery (BCS) rate was similar in both groups; 68% in the MRI group versus 66% in the control group. The number of re-excisions performed because of positive resection margins after primary BCS was increased in the MRI group; 18/53 (34%) patients in the MRI group versus 6/50 (12%) in the control group (p=0.008). The number of conversions to mastectomy did not differ significantly between groups. Overall, the rate of an additional surgical intervention (BCS and mastectomy combined) after initial breast conserving surgery was 24/53 (45%) in the MRI group versus 14/50 (28%) in the control group (p=0.069). Addition of MRI to routine clinical care in patients with nonpalpable breast cancer was paradoxically associated with an increased re-excision rate. Breast MRI should not be used routinely for preoperative work-up of patients with nonpalpable breast cancer. Copyright © 2010 Elsevier Ltd. All rights reserved.

Preparation of armored RNA as a control for multiplex real-time reverse transcription-PCR detection of influenza virus and severe acute respiratory syndrome coronavirus.

PubMed

Yu, Xin-Fen; Pan, Jing-Cao; Ye, Rong; Xiang, Hai-Qing; Kou, Yu; Huang, Zhi-Cheng

2008-03-01

The common respiratory viruses, including influenza A, influenza B, and newly emerging severe acute respiratory syndrome (SARS) viruses, may cause similar clinical symptoms. Therefore, differential diagnosis of these virus pathogens is frequently required for single clinical samples. In addition, there is an urgent need for noninfectious and stable RNA standards and controls for multivirus detection. In this study, reverse transcription-PCR (RT-PCR) targeting of the RNAs of influenza A and influenza B viruses and SARS coronavirus was performed, and the resulting products were spliced into a fragment which was packaged into armored RNA for use as a noninfectious, quantifiable synthetic substitute. Furthermore, in the present study we developed a multiplex real-time RT-PCR assay in which the armored RNA was used as an external positive control and the three RNA viruses could be detected simultaneously in a single reaction mix. The detection limit of the multiplex real-time PCR was 10 copies/microl of armored RNA.

Bulbar conjunctival fluorescein staining in hydrogel contact lens wearers.

PubMed

Lakkis, C; Brennan, N A

1996-07-01

To evaluate the clinical usefulness of bulbar conjunctival staining in assessing hydrogel contact lens patients. Overall staining, as well as staining at five separate sites (limbal, nasal band, temporal band, superior, and inferior) was graded on an analog scale in 48 contact lens wearing subjects and 50 controls. The degree to which subjects experienced sensations of dryness, wateriness, itchiness, grittiness, and comfort was also assessed using analog scales. Some measure of conjunctival staining was noted in 98% of subjects, with contact lens wearers showing statistically significant greater staining than controls. Only 12% of controls showed staining of greater than grade 1 (equivalent), whereas 62% of contact lens wearers were above this level. Regression analysis showed that overall staining was a function of whether contact lenses were worn, the degree of dryness, and the amount of itchiness. Conjunctival fluorescein staining appears to serve some clinical usefulness as a composite indicator for certain factors and symptoms and, in addition, provides information which is unique for each individual.

Enhancing nurses' ethical practice: development of a clinical ethics program.

PubMed

McDaniel, C

1998-06-01

There is increasing attention paid to ethics under managed care; however, few clinical-based ethics programs are reported. This paper reports the assessment and outcomes of one such program. A quasi-experimental research design with t-tests is used to assess the outcome differences between participants and control groups. There are twenty nurses in each; they are assessed for comparability. Differences are predicted on two outcomes using reliable and valid measures: nurses' time with their patients in ethics discussions, and nurses' opinions regarding their clinical ethics environments. Results reveal a statistically significant difference (p <.05) between the two groups, with modest positive change in the participants. Additional exploratory analyses are reported on variables influential in health care services.

Dysfunction of the neuromuscular junction in spinal muscular atrophy types 2 and 3.

PubMed

Wadman, Renske I; Vrancken, Alexander F J E; van den Berg, Leonard H; van der Pol, W Ludo

2012-11-13

Spinal muscular atrophy (SMA) is pathologically characterized by degeneration of anterior horn cells. Recent observations in animal models of SMA and muscle tissue from patients with SMA suggest additional abnormalities in the development and maturation of the neuromuscular junction. We therefore evaluated neuromuscular junction function in SMA with repetitive nerve stimulation. In this case-control study, repetitive nerve stimulation was performed in 35 patients with SMA types 2, 3, and 4, 20 healthy controls, and 5 controls with motor neuron disease. Pathologic decremental responses (>10%) during 3-Hz repetitive nerve stimulation were observed in 17 of 35 patients (49%) with SMA types 2 and 3, but not in healthy controls or controls with motor neuron disease. None of the patients or controls had an abnormal incremental response of >60%. The presence of an abnormal decremental response was not specific for the type of SMA, nor was it associated with compound muscle action potential amplitude, clinical scores, or disease duration. Two of 4 patients with SMA type 3 who tried pyridostigmine reported increased stamina. These data suggest dysfunction of the neuromuscular junction in patients with SMA types 2 and 3. Therefore, drugs that facilitate neuromuscular transmission are candidate drugs for evaluation in carefully designed, placebo-controlled, clinical trials.

The relationship between clinical insight and cognitive and affective empathy in schizophrenia.

PubMed

Atoui, Mia; El Jamil, Fatima; El Khoury, Joseph; Doumit, Mark; Syriani, Nathalie; Khani, Munir; Nahas, Ziad

2018-06-01

Schizophrenia is often associated with poor clinical insight (unawareness of mental illness and its symptoms) and deficits in empathy, which are important for social functioning. Cognitive empathy has been linked to clinical insight while affective empathy and its role in insight and pathology have received mixed evidence. Instruments assessing symptomatology (Positive and Negative Syndrome Scale; PANSS), clinical insight (Scales to assess awareness of mental disorders; SUMD), and cognitive and affective empathy were administered to 22 participants with first episode and chronic schizophrenia and 21 healthy controls. Self-report, parent-report, and performance based measures were used to assess cognitive and affective empathy (The interpersonal reactivity index; IRI/Reading the Mind in the Eyes Test/Faux Pas) to reduce bias and parse shared variance. Age of onset, gender, and symptomatology emerged as significant predictors of poor clinical insight. Additionally, the fantasy subscale of the IRI as reported by parents emerged as a positive predictor while the personal distress (parent report) subscale emerged as a negative predictor of awareness into mental illness. There were significant differences on performance-based measures of empathy between the control and schizophrenia groups. Findings suggest that affective empathy is relatively intact across phases of illness whereas cognitive empathy abilities are compromised and could be targets for psychotherapy intervention.

Remapping cortical modulation for electrocorticographic brain-computer interfaces: a somatotopy-based approach in individuals with upper-limb paralysis

NASA Astrophysics Data System (ADS)

Degenhart, Alan D.; Hiremath, Shivayogi V.; Yang, Ying; Foldes, Stephen; Collinger, Jennifer L.; Boninger, Michael; Tyler-Kabara, Elizabeth C.; Wang, Wei

2018-04-01

Objective. Brain-computer interface (BCI) technology aims to provide individuals with paralysis a means to restore function. Electrocorticography (ECoG) uses disc electrodes placed on either the surface of the dura or the cortex to record field potential activity. ECoG has been proposed as a viable neural recording modality for BCI systems, potentially providing stable, long-term recordings of cortical activity with high spatial and temporal resolution. Previously we have demonstrated that a subject with spinal cord injury (SCI) could control an ECoG-based BCI system with up to three degrees of freedom (Wang et al 2013 PLoS One). Here, we expand upon these findings by including brain-control results from two additional subjects with upper-limb paralysis due to amyotrophic lateral sclerosis and brachial plexus injury, and investigate the potential of motor and somatosensory cortical areas to enable BCI control. Approach. Individuals were implanted with high-density ECoG electrode grids over sensorimotor cortical areas for less than 30 d. Subjects were trained to control a BCI by employing a somatotopic control strategy where high-gamma activity from attempted arm and hand movements drove the velocity of a cursor. Main results. Participants were capable of generating robust cortical modulation that was differentiable across attempted arm and hand movements of their paralyzed limb. Furthermore, all subjects were capable of voluntarily modulating this activity to control movement of a computer cursor with up to three degrees of freedom using the somatotopic control strategy. Additionally, for those subjects with electrode coverage of somatosensory cortex, we found that somatosensory cortex was capable of supporting ECoG-based BCI control. Significance. These results demonstrate the feasibility of ECoG-based BCI systems for individuals with paralysis as well as highlight some of the key challenges that must be overcome before such systems are translated to the clinical realm. ClinicalTrials.gov Identifier: NCT01393444.

Impulse control disorders in Parkinson disease: a cross-sectional study of 3090 patients.

PubMed

Weintraub, Daniel; Koester, Juergen; Potenza, Marc N; Siderowf, Andrew D; Stacy, Mark; Voon, Valerie; Whetteckey, Jacqueline; Wunderlich, Glen R; Lang, Anthony E

2010-05-01

An association between dopamine-replacement therapies and impulse control disorders (ICDs) in Parkinson disease (PD) has been suggested in preliminary studies. To ascertain point prevalence estimates of 4 ICDs in PD and examine their associations with dopamine-replacement therapies and other clinical characteristics. Cross-sectional study using an a priori established sampling procedure for subject recruitment and raters blinded to PD medication status. Three thousand ninety patients with treated idiopathic PD receiving routine clinical care at 46 movement disorder centers in the United States and Canada. The Massachusetts Gambling Screen score for current problem/pathological gambling, the Minnesota Impulsive Disorders Interview score for compulsive sexual behavior and buying, and Diagnostic and Statistical Manual of Mental Disorders research criteria for binge-eating disorder. An ICD was identified in 13.6% of patients (gambling in 5.0%, compulsive sexual behavior in 3.5%, compulsive buying in 5.7%, and binge-eating disorder in 4.3%), and 3.9% had 2 or more ICDs. Impulse control disorders were more common in patients treated with a dopamine agonist than in patients not taking a dopamine agonist (17.1% vs 6.9%; odds ratio [OR], 2.72; 95% confidence interval [CI], 2.08-3.54; P < .001). Impulse control disorder frequency was similar for pramipexole and ropinirole (17.7% vs 15.5%; OR, 1.22; 95% CI, 0.94-1.57; P = .14). Additional variables independently associated with ICDs were levodopa use, living in the United States, younger age, being unmarried, current cigarette smoking, and a family history of gambling problems. Dopamine agonist treatment in PD is associated with 2- to 3.5-fold increased odds of having an ICD. This association represents a drug class relationship across ICDs. The association of other demographic and clinical variables with ICDs suggests a complex relationship that requires additional investigation to optimize prevention and treatment strategies. clinicaltrials.gov Identifier: NCT00617019.

Effect of Epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study

PubMed Central

Harkema, Susan; Gerasimenko, Yury; Hodes, Jonathan; Burdick, Joel; Angeli, Claudia; Chen, Yangsheng; Ferreira, Christie; Willhite, Andrea; Rejc, Enrico; Grossman, Robert G.; Edgerton, V. Reggie

2011-01-01

Summary Background Repeated periods of stimulation of the spinal cord and training seems to have amplified the ability to consciously control movement. Methods An individual three years post C7-T1 subluxation presented with a complete loss of clinically detectable voluntary motor function and partial preservation of sensation below the T1 cord segment. Following 170 locomotor training sessions, a 16-electrode array was surgically placed on the dura (L1-S1 cord segments) to allow for chronic electrical stimulation. After implantation and throughout stand retraining with epidural stimulation, 29 experiments were performed. Extensive stimulation combinations and parameters were tested to achieve standing and stepping. Findings Epidural stimulation enabled the human lumbosacral spinal circuitry to dynamically elicit full weight-bearing standing with assistance provided only for balance for 4·25 minutes in a subject with a clinically motor complete SCI. This occurred when using stimulation at parameters optimized for standing while providing bilateral load-bearing proprioceptive input. Locomotor-like patterns were also observed when stimulation parameters were optimized for stepping. In addition, seven months after implantation, the subject recovered supraspinal control of certain leg movements, but only during epidural stimulation. Interpretation Even after a severe low cervical spinal injury, the neural networks remaining within the lumbosacral segments can be reactivated into functional states so that it can recognize specific details of ensembles of sensory input to the extent that it can serve as the source of neural control. In addition, newly formed supraspinal input to this same lumbosacral segments can re-emerge as another source of control. Task specific training with epidural stimulation may have reactivated previously silent spared neural circuits or promoted plasticity. This suggests that these interventions could be a viable clinical approach for functional recovery after severe paralysis. Funding National Institutes of Health and Christopher and Dana Reeve Foundation. PMID:21601270

Key observations from the NHLBI Asthma Clinical Research Network.

PubMed

Szefler, Stanley J; Chinchilli, Vernon M; Israel, Elliot; Denlinger, Loren Clark; Lemanske, Robert F; Calhoun, William; Peters, Stephen P

2012-05-01

The National Heart, Lung and Blood Institute (NHLBI) Asthma Clinical Research Network (ACRN) recently completed its work after 20 years of collaboration as a multicentre clinical trial network. When formed, its stated mission was to perform multiple controlled clinical trials for treating patients with asthma by dispassionately examining new and existing therapies, and to rapidly communicate its findings to the medical community. The ACRN conducted 15 major clinical trials. In addition, clinical data, manual of operations, protocols and template informed consents from all ACRN trials are available via NHLBI BioLINCC (https://biolincc.nhlbi.nih.gov/studies/). This network contributed major insights into the use of inhaled corticosteroids, short-acting and long-acting ß-adrenergic agonists, leukotriene receptor antagonists, and novel agents (tiotropium, colchicine and macrolide antibiotics). They also pioneered studies of the variability in drug response, predictors of treatment response and pharmacogenetics. This review highlights the major research observations from the ACRN that have impacted the current management of asthma.

Malaria Diagnostics in Clinical Trials

PubMed Central

Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann

2013-01-01

Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wide array of available malaria diagnostic tests for their suitability for screening trial participants and/or obtaining study endpoints for malaria clinical trials, including studies of HIV/malaria co-infection and other malaria natural history studies. The MLN provides recommendations on microscopy, rapid diagnostic tests, serologic tests, and molecular assays to guide selection of the most appropriate test(s) for specific research objectives. In addition, this report provides recommendations regarding quality management to ensure reproducibility across sites in clinical trials. Performance evaluation, quality control, and external quality assessment are critical processes that must be implemented in all clinical trials using malaria tests. PMID:24062484

Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion.

PubMed

Reches, A; Kutcher, J; Elbin, R J; Or-Ly, H; Sadeh, B; Greer, J; McAllister, D J; Geva, A; Kontos, A P

2017-01-01

The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician's decision-making process. The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions.

Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion

PubMed Central

Reches, A.; Kutcher, J.; Elbin, R. J.; Or-Ly, H.; Sadeh, B.; Greer, J.; McAllister, D. J.; Geva, A.; Kontos, A. P.

2017-01-01

ABSTRACT Background: The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician’s decision-making process. Objective: The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Methods: Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Results: Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. Conclusion: The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions. PMID:28055228

The effect of student self-video of performance on clinical skill competency: a randomised controlled trial.

PubMed

Maloney, Stephen; Storr, Michael; Morgan, Prue; Ilic, Dragan

2013-03-01

Emerging technologies and student information technology literacy are enabling new methods of teaching and learning for clinical skill performance. Facilitating experiential practice and reflection on performance through student self-video, and exposure to peer benchmarks, may promote greater levels of skill competency. This study examines the impact of student self-video on the attainment of clinical skills. A total of 60 Physiotherapy students (100%) consented to participate in the randomised controlled trial. One group (50%) was taught a complex clinical skill with regular practical tutoring, whilst the other group (50%) supplemented the tutoring with a self-video task aimed at promoting reflection on performance. Student skill performance was measured in an objective structured clinical examination (OSCE). Students also completed an anonymous questionnaire, which explored their perception of their learning experiences. Students received significantly higher scores in the OSCE when the examined clinical skill had been supplemented with a self-video of performance task (P = 0.048). Descriptive analysis of the questionnaires relating to student perceptions on the teaching methods identified that the self-video of performance task utilised contributed to improvement in their clinical performance and their confidence for future clinical practice. Students identified a number of aspects of the submission process that contributed to this perception of educational value. The novel results of this study demonstrate that greater clinical skill competency is achieved when traditional tutoring methods are supplemented with student self-video of performance tasks. Additional benefits included the ability of staff and students to monitor longitudinal performance, and an increase in feedback opportunities.

Characteristics of the sequence effect in Parkinson's disease.

PubMed

Kang, Suk Yun; Wasaka, Toshiaki; Shamim, Ejaz A; Auh, Sungyoung; Ueki, Yoshino; Lopez, Grisel J; Kida, Tetsuo; Jin, Seung-Hyun; Dang, Nguyet; Hallett, Mark

2010-10-15

The sequence effect (SE) in Parkinson's disease (PD) is progressive slowing of sequential movements. It is a feature of bradykinesia, but is separate from a general slowness without deterioration over time. It is commonly seen in PD, but its physiology is unclear. We measured general slowness and the SE separately with a computer-based, modified Purdue pegboard in 11 patients with advanced PD. We conducted a placebo-controlled, four-way crossover study to learn whether levodopa and repetitive transcranial magnetic stimulation (rTMS) could improve general slowness or the SE. We also examined the correlation between the SE and clinical fatigue. Levodopa alone and rTMS alone improved general slowness, but rTMS showed no additive effect on levodopa. Levodopa alone, rTMS alone, and their combination did not alleviate the SE. There was no correlation between the SE and fatigue. This study suggests that dopaminergic dysfunction and abnormal motor cortex excitability are not the relevant mechanisms for the SE. Additionally, the SE is not a component of clinical fatigue. Further work is needed to establish the physiology and clinical relevance of the SE. © 2010 Movement Disorder Society.

Use of ossein-hydroxyapatite complex in the prevention of bone loss: a review.

PubMed

Castelo-Branco, C; Dávila Guardia, J

2015-02-01

The ossein-hydroxyapatite complex (OHC) is a microcrystalline form of calcium which provides a number of additional minerals (magnesium, phosphorus, potassium, zinc), and proteins (osteocalcin, type I collagen, type I insulin growth factor I and II, transforming growth factor beta) associated with bone metabolism. The objective of this review is to examine the role of OHC in preventing bone loss in different conditions. A review of clinical trials assessing the relationship between OHC and bone loss was made using the following data sources: Medline (from 1966 to December 2013), the Cochrane Controlled Clinical Trials Register, Embase (up to December 2013), contact with companies marketing the supplements studied, and reference lists. Different randomized, clinical trials and meta-analysis suggest that OHC is more effective than calcium supplements in maintaining bone mass in postmenopausal women and in different conditions related to bone loss. In addition, OHC improves pain symptoms and accelerates fracture consolidation in patients with osteopenia or osteoporosis. The ossein-hydroxyapatite complex is significantly more effective in preventing bone loss than calcium carbonate.

Long-term myocardial preservation: beneficial and additive effects of polarized arrest (Na+-channel blockade), Na+/H+-exchange inhibition, and Na+/K+/2Cl- -cotransport inhibition combined with calcium desensitization.

PubMed

Snabaitis, A K; Chambers, D

1999-11-27

Polarized arrest, induced by tetrodotoxin (TTX) at an optimal concentration of 22 micromol/L, has been shown to reduce ionic imbalance and improve myocardial preservation compared with hyperkalemic (depolarized) arrest. Additional pharmacologic manipulation of ionic changes (involving inhibition of Na+ influx by the Na+/H+ exchanger [HOE694] and Na+/K+/2Cl- cotransporter [furosemide], and calcium desensitization [BDM]) may further improve long-term preservation. In this study, we (i) established optimal concentrations of each drug, (ii) determined additive effects of optimal concentrations of each drug and (iii) compared our optimal preservation solution to an established depolarizing cardioplegia (St Thomas' Hospital solution No 2: STH2) used during long-term hypothermic storage for clinical transplantation. The isolated working rat heart, perfused with Krebs Henseleit (KH) buffer was used; cardiac function was measured after 20 min aerobic working mode perfusion. The hearts (n=6/group) were arrested with a 2 ml infusion (for 30 sec) of the polarizing (control) solution (22 micromol/L TTX in KH) or control+drug and subjected to 5 hr or 8 hr of storage at 7.5 degrees C in the arresting solution. Postischemic function during reperfusion was measured (expressed as percentage of preischemic function). Dose-response studies established optimal concentrations of HOE694 (10 micromol/L), furosemide (1.0 micromol/L) and BDM (30 mmol/L) in the polarizing (control) solution. Sequential addition to the control solution (Group I) of optimal concentrations of HOE694 (Group II), furosemide (Group III), and BDM (Group IV) were compared with STH2 (Group V); postischemic recovery of aortic flow was 29+/-7%, 49+/-6%*, 56+/-2%*, 76+/-3%*, and 25+/-6%, respectively (*P<0.05 vs. I and V). Creatine kinase leakage was lowest, and myocardial ATP content was highest in Group IV. A polarizing preservation solution (KH+TTX) containing HOE694, furosemide, and BDM significantly enhanced long-term preservation compared with an optimized depolarizing solution (STH2) used clinically for long-term donor heart preservation.

Association of brain-derived neurotrophic factor (BDNF) Val66Met polymorphism with early-onset bipolar disorder.

PubMed

Nassan, Malik; Croarkin, Paul E; Luby, Joan L; Veldic, Marin; Joshi, Paramjit T; McElroy, Susan L; Post, Robert M; Walkup, John T; Cercy, Kelly; Geske, Jennifer R; Wagner, Karen D; Cuellar-Barboza, Alfredo B; Casuto, Leah; Lavebratt, Catharina; Schalling, Martin; Jensen, Peter S; Biernacka, Joanna M; Frye, Mark A

2015-09-01

Brain-derived neurotrophic factor (BDNF) Val66Met (rs6265) functional polymorphism has been implicated in early-onset bipolar disorder. However, results of studies are inconsistent. We aimed to further explore this association. DNA samples from the Treatment of Early Age Mania (TEAM) and Mayo Clinic Bipolar Disorder Biobank were investigated for association of rs6265 with early-onset bipolar disorder. Bipolar cases were classified as early onset if the first manic or depressive episode occurred at age ≤19 years (versus adult-onset cases at age >19 years). After quality control, 69 TEAM early-onset bipolar disorder cases, 725 Mayo Clinic bipolar disorder cases (including 189 early-onset cases), and 764 controls were included in the analysis of association, assessed with logistic regression assuming log-additive allele effects. Comparison of TEAM cases with controls suggested association of early-onset bipolar disorder with the rs6265 minor allele [odds ratio (OR) = 1.55, p = 0.04]. Although comparison of early-onset adult bipolar disorder cases from the Mayo Clinic versus controls was not statistically significant, the OR estimate indicated the same direction of effect (OR = 1.21, p = 0.19). When the early-onset TEAM and Mayo Clinic early-onset adult groups were combined and compared with the control group, the association of the minor allele rs6265 was statistically significant (OR = 1.30, p = 0.04). These preliminary analyses of a relatively small sample with early-onset bipolar disorder are suggestive that functional variation in BDNF is implicated in bipolar disorder risk and may have a more significant role in early-onset expression of the disorder. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Recurrent duplications of the annexin A1 gene (ANXA1) in autism spectrum disorders

PubMed Central

2014-01-01

Background Validating the potential pathogenicity of copy number variants (CNVs) identified in genome-wide studies of autism spectrum disorders (ASD) requires detailed assessment of case/control frequencies, inheritance patterns, clinical correlations, and functional impact. Here, we characterize a small recurrent duplication in the annexin A1 (ANXA1) gene, identified by the Autism Genome Project (AGP) study. Methods From the AGP CNV genomic screen in 2,147 ASD individuals, we selected for characterization an ANXA1 gene duplication that was absent in 4,964 population-based controls. We further screened the duplication in a follow-up sample including 1,496 patients and 410 controls, and evaluated clinical correlations and family segregation. Sequencing of exonic/downstream ANXA1 regions was performed in 490 ASD patients for identification of additional variants. Results The ANXA1 duplication, overlapping the last four exons and 3’UTR region, had an overall prevalence of 11/3,643 (0.30%) in unrelated ASD patients but was not identified in 5,374 controls. Duplication carriers presented no distinctive clinical phenotype. Family analysis showed neuropsychiatric deficits and ASD traits in multiple relatives carrying the duplication, suggestive of a complex genetic inheritance. Sequencing of exonic regions and the 3’UTR identified 11 novel changes, but no obvious variants with clinical significance. Conclusions We provide multilevel evidence for a role of ANXA1 in ASD etiology. Given its important role as mediator of glucocorticoid function in a wide variety of brain processes, including neuroprotection, apoptosis, and control of the neuroendocrine system, the results add ANXA1 to the growing list of rare candidate genetic etiological factors for ASD. PMID:24720851

Impact of the European Clinical Trials Directive on academic clinical research.

PubMed

Baeyens, A J

2004-01-01

With the adoption of the Clinical Trials Directive it was Europe's intention to make the performance of multi-national clinical trials in Europe easier through the harmonization of the regulatory procedures. As the Directive was mainly conceived to facilitate the performance of multi-national clinical trials to develop new drugs, it is to be determined to what extent academic clinical trials will be concerned by the Directive and more importantly what will be its impact on daily academic clinical research. Contrary to several national regulations the scope of the Directive is very large only excluding non-interventional trials. This implies that most of the academic clinical trials will be concerned by the Directive. Besides the handling of the regulatory procedures in the different countries, issues related to insurance, labeling requirements and provision of the investigational medical products will expose the academic sponsor to additional administrative and financial challenges that will have to be handled appropriately, as the academic sponsors will be controlled by Inspectors regarding their compliance with the new regulations to come.

Just-in-time information improved decision-making in primary care: a randomized controlled trial.

PubMed

McGowan, Jessie; Hogg, William; Campbell, Craig; Rowan, Margo

2008-01-01

The "Just-in-time Information" (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued. In this study, providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants. Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day, thus potentially increasing patient access to care. Such services may reduce costs through decreasing the need for referrals, further tests, and other courses of action. Controlled-Trials.com ISRCTN96823810.

Just-in-Time Information Improved Decision-Making in Primary Care: A Randomized Controlled Trial

PubMed Central

McGowan, Jessie; Hogg, William; Campbell, Craig; Rowan, Margo

2008-01-01

Background The “Just-in-time Information” (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. Methods and Finding A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued. Conclusions In this study, providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants. Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day, thus potentially increasing patient access to care. Such services may reduce costs through decreasing the need for referrals, further tests, and other courses of action. Trial Registration Controlled-Trials.com ISRCTN96823810 PMID:19023446

Mean platelet volume: a potential biomarker of the risk and prognosis of heart disease.

PubMed

Choi, Dong-Hyun; Kang, Seong-Ho; Song, Heesang

2016-11-01

Platelets are essential for progression of atherosclerotic lesions, plaque destabilization, and thrombosis. They secrete and express many substances that are crucial mediators of coagulation, inflammation, and atherosclerosis. Mean platelet volume (MPV) is a precise measure of platelet size, and is routinely reported during complete blood count analysis. Emerging evidence supports the use of MPV as a biomarker predicting the risk of ischemic stroke in patients with atrial fibrillation, and as a guide for prescription of anticoagulation and rhythm-control therapy. In addition, MPV may predict the clinical outcome of percutaneous coronary intervention (PCI) in patients with coronary artery disease and indicate whether additional adjunctive therapy is needed to improve clinical outcomes. This review focuses on the current evidence that MPV may be a biomarker of the risk and prognosis of common heart diseases, particularly atrial fibrillation and coronary artery disease treated via PCI.

Paroxetine reduces social anxiety in individuals with a co-occurring alcohol use disorder

PubMed Central

Book, Sarah W.; Thomas, Suzanne E.; Randall, Patrick K.; Randall, Carrie L.

2008-01-01

Patients with social anxiety disorder who are seen in clinical practice commonly have additional psychiatric comorbidity, including alcohol use disorders. The first line treatment for social anxiety disorder is selective-serotonin-reuptake-inhibitors (SSRIs), such as paroxetine. However, the efficacy of SSRIs has been determined with studies that excluded alcoholics. Forty two subjects with social anxiety and a co-occurring alcohol use disorder participated in a 16-week, double-blind, placebo-controlled clinical trial to determine the efficacy of paroxetine for social anxiety in patients with co-occurring alcohol problems. Paroxetine was superior to placebo in reducing social anxiety, as measured by the Liebowitz Social Anxiety Scale total and subscale scores and additional measures of social anxiety. This study provides the first evidence-based recommendation for the use of an SSRI to treat social anxiety in this patient population. PMID:17448631

Mothers' and fathers' ratings of family relationship quality: associations with preadolescent and adolescent anxiety and depressive symptoms in a clinical sample.

PubMed

Queen, Alexander H; Stewart, Lindsay M; Ehrenreich-May, Jill; Pincus, Donna B

2013-06-01

This study examined the independent associations among three family relationship quality factors--cohesion, expressiveness, and conflict--with youth self-reported depressive and anxiety symptoms in a clinical sample of anxious and depressed youth. Ratings of family relationship quality were obtained through both mother and father report. The sample included families of 147 preadolescents and adolescents (56.6 % female; 89.8 % Caucasian), 11-18 years old (M = 13.64, SD = 1.98) assigned a principal diagnosis of an anxiety or depressive disorder. When controlling for age and concurrent anxiety symptoms, regression analyses revealed that for boys, both father- and mother-rated family cohesion predicted depressive symptoms. For girls, mother-rated family expressiveness and conflict predicted depressive symptoms. Youth anxiety symptoms were not significantly associated with any family relationship variables, controlling for concurrent depressive symptoms. Findings suggest that parent-rated family relationship factors may be more related to youth depressive than anxiety symptoms in this clinical sample. In addition, family cohesion, as perceived by parents, may be more related to boys' depression, whereas expressiveness and conflict (as rated by mothers) may be more related to girls' depression. Clinical implications and recommendations for future research are discussed.

Surgical microscope may enhance root coverage with subepithelial connective tissue graft: a randomized-controlled clinical trial.

PubMed

Bittencourt, Sandro; Del Peloso Ribeiro, Erica; Sallum, Enilson A; Nociti, Francisco H; Casati, Márcio Zaffalon

2012-06-01

Minimally invasive techniques have broadened the horizons of periodontal plastic surgery to improve treatment outcomes. Thus, the purpose of this clinical trial was to compare root coverage, postoperative morbidity, and esthetic outcomes of subepithelial connective tissue graft (SCTG) technique with or without the use of a surgical microscope in the treatment of gingival recessions. In this split-mouth study, twenty-four patients with bilateral Miller's Class I or II buccal gingival recessions ≥2.0 mm in canines or premolars were selected. Gingival recessions were randomly designated to receive treatment with SCTG with or without the assistance of the surgical microscope (test and control groups, respectively). Clinical parameters evaluated included the following: depth (RH) and width (RW) of the gingival defect, width (WKT) and thickness (TKT) of keratinized tissue, probing depth (PD), and clinical attachment level (CAL). Postoperative morbidity was evaluated by means of an analog visual scale and questionnaire. Patient satisfaction was also evaluated with a questionnaire. Descriptive statistics were expressed as mean ± SD. Repeated-measures analysis of variance was used for examination of differences regarding PD, CAL, and TKT. The Wilcoxon test was used to detect differences between groups and the Friedman test to detect differences within group regarding WKT, RH, and RW. The average percentages of root coverage for test and control treatments, after 12 months, were 98.0% and 88.3%, respectively (P <0.05). Complete root coverage was achieved in 87.5% and 58.3% of teeth treated in test and control groups, respectively. For all parameters except recession height, there was an improvement in the final examination but without difference between treatments. For the RH, a lower value was found in the test group compared to the control group (P <0.05). In the test group, all patients were satisfied with the esthetics obtained, and 19 patients (79.1%) were satisfied in the control group. For postoperative morbidity, 14 patients in each of the two treatment groups did not use analgesics for pain control. Both approaches were capable of producing root coverage; however, use of the surgical microscope was associated with additional clinical benefits in the treatment of teeth with gingival recessions.

[Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

PubMed

Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

2011-10-01

To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

Mindfulness based cognitive therapy versus treatment as usual in adults with attention deficit hyperactivity disorder (ADHD).

PubMed

Janssen, Lotte; Kan, Cornelis C; Carpentier, Pieter J; Sizoo, Bram; Hepark, Sevket; Grutters, Janneke; Donders, Rogier; Buitelaar, Jan K; Speckens, Anne E M

2015-09-15

Adults with attention deficit hyperactivity disorder (ADHD) often present with a lifelong pattern of core symptoms that is associated with impairments of functioning in daily life. This has a substantial personal and economic impact. In clinical practice there is a high need for additional or alternative interventions for existing treatments, usually consisting of pharmacotherapy and/or psycho-education. Although previous studies show preliminary evidence for the effectiveness of mindfulness-based interventions in reducing ADHD symptoms and improving executive functioning, these studies have methodological limitations. This study will take account of these limitations and will examine the effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in further detail. A multi-centre, parallel-group, randomised controlled trial will be conducted in N = 120 adults with ADHD. Patients will be randomised to MBCT in addition to treatment as usual (TAU) or TAU alone. Assessments will take place at baseline and at three, six and nine months after baseline. Primary outcome measure will be severity of ADHD symptoms rated by a blinded clinician. Secondary outcome measures will be self-reported ADHD symptoms, executive functioning, mindfulness skills, self-compassion, positive mental health and general functioning. In addition, a cost-effectiveness analysis will be conducted. This trial will offer valuable information about the clinical and cost-effectiveness of MBCT in addition to TAU compared to TAU alone in adults swith ADHD. ClinicalTrials.gov NCT02463396. Registered 8 June 2015.

Characterization of a whole, inactivated influenza (H5N1) vaccine.

PubMed

Tada, Yoshikazu

2008-11-01

Effective vaccines against the highly pathogenic influenza A/H5N1 virus are being developed worldwide. In Japan, two adjuvanted, inactivated, whole-virion influenza vaccines were recently developed and licensed as mock-up, pre-pandemic vaccine formulations by the Ministry of Health and Labor Welfare of Japan. During the vaccine design and development process, various obstacles were overcome and, in this report, we introduce the non clinical production, immunogenicity data in human and development process that was associated with egg-derived adjuvanted, inactivated, whole-virion influenza A (H5N1) vaccine. Pilot lots of H5N1 vaccine were produced using the avirulent H5N1 reference strain A/Vietnam/1194/2004 (H5N1) NIBRG-14 and administered following adsorption with aluminum hydroxide as an adjuvant. Quality control and formulation stability tests were performed before clinical trials were initiated (phase I-III). The research foundation for microbial diseases of Osaka University (BIKEN) carried out vaccine production, quality control, stability testing and the phase I clinical trial in addition to overseeing the licensing of this vaccine. Mitsubishi Chemical Safety Institute Ltd. carried out the non clinical pharmacological toxicity and safety studies and the Japanese medical association carried out the phase II/III trials. Phase I-III trials took place in 2006. The production processes were well controlled by established tests and validations. Vaccine quality was confirmed by quality control, stability and pre-clinical tests, and the vaccine was approved as a mock-up, pre-pandemic vaccine by the Ministry of Health and Labor Welfare of Japan. Numerous safety and efficacy procedures were carried out prior to the approval of the described vaccine formulation. Some of these procedures were of particular importance e.g., vaccine development, validation, and quality control tests that included strict monitoring of the hemagglutinin (HA) content of the vaccine formulations. Improving vaccine productivity, shortening the production period and improving antigen yield of the avirulent vaccine strains were also considered important vaccine development criteria.

Epidemic keratoconjunctivitis outbreak at a tertiary referral eye care clinic.

PubMed

Montessori, V; Scharf, S; Holland, S; Werker, D H; Roberts, F J; Bryce, E

1998-08-01

An outbreak of epidemic keratoconjunctivitis (EKC) occurred at a tertiary referral eye care clinic between late September and mid-November 1995. Before the outbreak, instruments were cleaned with 70% isopropyl alcohol and handwashing between patients was not routine. Infection control measures were implemented when the outbreak was recognized in mid-October. Control measures included triaging suspected cases to a separate waiting area, cohorting cases to a specific examining room, endorsing the use of gloves and handwashing during examinations of patients, and cleaning instruments with a buffered bleach solution. Thirty-six cases were diagnosed before the infection control measures were taken, and 3 cases were seen after the control measures were taken. Also, numerous secondary cases occurred in the community. No additional cases were diagnosed from DEcember to February 25, 1996. Acquisition of the infection was linked to visits to 4 of 20 physicians in the eye clinic with 61% of cases associated with visits to 1 of those 4 physicians. The use of diagnostic lenses applied directly to the eye was associated with infection (odds ratio = 2.83, 95% confidence interval = 0.79 to 10.4), although this did not reach statistical significance. The use of tonometers, ophthalmic solutions, or laser therapy was not associated with infection, and all environmental cultures were negative. This outbreak emphasizes the need for implementation of routine infection control guidelines to prevent nosocomial transmission of epidemic keratoconjunctivitis and stresses the need for appropriate disinfection of instruments.

[Temporomandibular disorders and Ehlers-Danlos syndrome, hypermobility type: A case-control study].

PubMed

Diep, D; Fau, V; Wdowik, S; Bienvenu, B; Bénateau, H; Veyssière, A

2016-09-01

The Ehlers-Danlos syndrome, hypermobility type (EDS-HT) is a rare genetic disease. Diagnosis is based on a combination of clinical criteria described in the classification of Villefranche. Diagnosis is difficult to make because of the lack of specific clinical signs and the absence of genetic testing. The EDS-TH manifests itself manly by musculoskeletal pain and joint hypermobility. Temporomandibular disorders (TMD) are also reported. Our aim was to objectify the presence and to qualify the type of TMD associated with the EDS-HT in order to propose an additional diagnostic argument. A prospective, monocenter case-control study, comparing a cohort of patients suffering from EDS-HT to a paired control group of healthy volunteers has been conducted. Clinical examination was standardized, including a general questioning, an oral examination and a temporomandibular joint examination following the TMD/RDC (temporomandibular disorders/research diagnostic criteria). Fourteen EDS-HT patients and 58 control patients were examined. The prevalence of TMDs (n=13; 92.9% vs. n=4; 6.9%; P=10(-11)) was significantly higher in the EDS-HT group. TMDs occurring in the EDS-HT group were complex, combining several mechanisms in contrast to the control group, where only one mechanism was found in all the patients (n=13; 92.9% vs. n=0; 0.0%). TMDs are strongly associated with RDS-HT. TMDs could therefore be used in the diagnosis of this disease. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Standardizing Naming Conventions in Radiation Oncology

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

Santanam, Lakshmi; Hurkmans, Coen; Mutic, Sasa

2012-07-15

Purpose: The aim of this study was to report on the development of a standardized target and organ-at-risk naming convention for use in radiation therapy and to present the nomenclature for structure naming for interinstitutional data sharing, clinical trial repositories, integrated multi-institutional collaborative databases, and quality control centers. This taxonomy should also enable improved plan benchmarking between clinical institutions and vendors and facilitation of automated treatment plan quality control. Materials and Methods: The Advanced Technology Consortium, Washington University in St. Louis, Radiation Therapy Oncology Group, Dutch Radiation Oncology Society, and the Clinical Trials RT QA Harmonization Group collaborated in creatingmore » this new naming convention. The International Commission on Radiation Units and Measurements guidelines have been used to create standardized nomenclature for target volumes (clinical target volume, internal target volume, planning target volume, etc.), organs at risk, and planning organ-at-risk volumes in radiation therapy. The nomenclature also includes rules for specifying laterality and margins for various structures. The naming rules distinguish tumor and nodal planning target volumes, with correspondence to their respective tumor/nodal clinical target volumes. It also provides rules for basic structure naming, as well as an option for more detailed names. Names of nonstandard structures used mainly for plan optimization or evaluation (rings, islands of dose avoidance, islands where additional dose is needed [dose painting]) are identified separately. Results: In addition to its use in 16 ongoing Radiation Therapy Oncology Group advanced technology clinical trial protocols and several new European Organization for Research and Treatment of Cancer protocols, a pilot version of this naming convention has been evaluated using patient data sets with varying treatment sites. All structures in these data sets were satisfactorily identified using this nomenclature. Conclusions: Use of standardized naming conventions is important to facilitate comparison of dosimetry across patient datasets. The guidelines presented here will facilitate international acceptance across a wide range of efforts, including groups organizing clinical trials, Radiation Oncology Institute, Dutch Radiation Oncology Society, Integrating the Healthcare Enterprise, Radiation Oncology domain (IHE-RO), and Digital Imaging and Communication in Medicine (DICOM).« less

Second measurement of morning systolic blood pressure is more closely associated with albuminuria.

PubMed

Sakabe, Kazumi; Fukui, Michiaki; Ushigome, Emi; Hamaguchi, Masahide; Tanaka, Toru; Atsuta, Haruhiko; Ohnishi, Masayoshi; Oda, Yohei; Hasegawa, Goji; Nakamura, Naoto

2012-08-01

It is important to control blood pressure as well as to control blood glucose for the prevention of diabetic nephropathy. However, to our knowledge, there are no reports investigating which blood pressure, including morning, evening and clinic, is more closely associated with albuminuria and whether one measurement is sufficient or not in patients with Type 2 diabetes. We measured morning, evening and clinic blood pressure and compared the area under the curve (AUC) of blood pressure for urinary albumin excretion equal to or more than 30 mg/g creatinine using receiver-operating characteristic curve analyses and odds ratio for albuminuria defined as urinary albumin excretion equal to or more than 30 mg/g creatinine in 858 patients with Type 2 diabetes. Odds ratio (95% confidence interval (CI)) of morning, evening and clinic systolic blood pressure for albuminuria was 1.034 (1.024 - 1.044), 1.033 (1.023 - 1.043) and 1.013 (1.055 - 1.021), respectively (p < 0.001 in all), and AUC of morning, evening and clinic systolic blood pressure was 0.644 (0.628 - 0.700) (p < 0.001 vs. clinic), 0.660 (0.623 - 0.696) (p < 0.001 vs. clinic) and 0.597 (0.559 - 0.636), respectively. AUC of the second morning systolic blood pressure was greater than the first (p = 0.033). The second measurement of morning systolic blood pressure is more closely associated with albuminuria than the first measurement of the morning in addition to clinic systolic blood pressure.

Procain and diethylaminoethanol influence on the release of free oxygen radicals by polymorphonuclear leukocytes, in rabbits and humans.

PubMed

Dolganiuc, A; Radu, D; Olinescu, A; Vrăbiescu, A

1998-01-01

The investigations were conducted on 3 groups of New Zealand rabbits: 1) controls; 2) injected with procain, i.m. 15 mg/kg body weight, daily, for 30 days; 3) injected with diethylaminoethanol (DEAE), 15 mg/kg body weight, daily, for 35 days. The study was made also on human leukocytes, isolated from the peripheral blood of 10 clinically healthy subjects (adults), procain and DEAE action being investigated in vitro. The free oxygen radicals (FOR) released by PMN leukocytes were evaluated by chemiluminescence, in vitro. Addition of procain or DEAE had no effect on the release of FOR by PMN leukocytes of control rabbits. In the experiment made on rabbits treated with procain or DEAE, the release of FOR by PMN leukocytes was much more reduced, as compared to controls. In the rabbits treated with procain, the intensity of the emitted light was 2.27 mV, in those treated with DEAE, 3.46 mV, while in the controls, the mean value was 6.74 mV. In the in vitro experiments performed on human PMN cells stimulated with opsonized zymosan (OZ), addition of procain or DEAE had an inhibiting effect on the FOR release. As compared to control, the means of the FOR values decreased from 59 to 41.2 mV in case of procain addition and from 67.7 to 50 mV in case of DEAE addition. The fact that the inflammation is associated with accumulation of free radicals, suggests the opportunity to test these substances, especially DEAE, as antioxidant agents.

Statistical inference on censored data for targeted clinical trials under enrichment design.

PubMed

Chen, Chen-Fang; Lin, Jr-Rung; Liu, Jen-Pei

2013-01-01

For the traditional clinical trials, inclusion and exclusion criteria are usually based on some clinical endpoints; the genetic or genomic variability of the trial participants are not totally utilized in the criteria. After completion of the human genome project, the disease targets at the molecular level can be identified and can be utilized for the treatment of diseases. However, the accuracy of diagnostic devices for identification of such molecular targets is usually not perfect. Some of the patients enrolled in targeted clinical trials with a positive result for the molecular target might not have the specific molecular targets. As a result, the treatment effect may be underestimated in the patient population truly with the molecular target. To resolve this issue, under the exponential distribution, we develop inferential procedures for the treatment effects of the targeted drug based on the censored endpoints in the patients truly with the molecular targets. Under an enrichment design, we propose using the expectation-maximization algorithm in conjunction with the bootstrap technique to incorporate the inaccuracy of the diagnostic device for detection of the molecular targets on the inference of the treatment effects. A simulation study was conducted to empirically investigate the performance of the proposed methods. Simulation results demonstrate that under the exponential distribution, the proposed estimator is nearly unbiased with adequate precision, and the confidence interval can provide adequate coverage probability. In addition, the proposed testing procedure can adequately control the size with sufficient power. On the other hand, when the proportional hazard assumption is violated, additional simulation studies show that the type I error rate is not controlled at the nominal level and is an increasing function of the positive predictive value. A numerical example illustrates the proposed procedures. Copyright © 2013 John Wiley & Sons, Ltd.

Lower Choline and Myo-Inositol in Temporo-Parietal Cortex Is Associated With Apathy in Amnestic MCI.

PubMed

Tumati, Shankar; Opmeer, Esther M; Marsman, Jan-Bernard C; Martens, Sander; Reesink, Fransje E; De Deyn, Peter P; Aleman, André

2018-01-01

Apathy is a common symptom in patients with amnestic mild cognitive impairment (aMCI) and is associated with an increased risk of progression to Alzheimer's disease (AD). The neural substrates underlying apathy in aMCI may involve multiple brain regions, including the anterior cingulate cortex and the temporo-parietal region. Here we investigated neurometabolites in brain regions that may underlie apathy in aMCI patients using proton magnetic resonance spectroscopy ( 1 H-MRS). Twenty-eight aMCI patients with varying degrees of apathy and 20 matched controls underwent 1 H-MRS. Spectra were acquired from single voxels in the posterior cingulate cortex (PCC), dorsal anterior cingulate cortex (DACC), right dorsolateral prefrontal cortex (DLPFC), and right temporo-parietal cortex (TPC). Apathy was measured with the Apathy Evaluation Scale (AES). Spearman partial correlations between metabolite concentrations in each region and severity of apathy were determined. Additionally, analyses of covariance (ANCOVA) were performed to determine whether metabolite changes differed between patients with or without clinically-diagnosed apathy. The degree of apathy was found to be negatively correlated with choline and myo-inositol (mI) in the TPC. Additional exploratory analyses suggested that N-acetylaspartate (NAA)/mI ratio was reduced in aMCI without clinical apathy but not in aMCI with clinical apathy. In the DACC, glutamate and glutamine (Glx) levels tended to be higher in the aMCI with apathy group compared to controls and reduced in association with depression scores. In conclusion, apathy in aMCI patients was associated with neurometabolite changes indicative of altered membranal integrity and glial function in the right TPC. Findings also indicated that in a clinically-diagnosed aMCI cohort, apathy symptoms may be suggestive of neural changes that are distinct from aMCI without apathy.

Preconception folate and vitamin B(6) status and clinical spontaneous abortion in Chinese women.

PubMed

Ronnenberg, Alayne G; Goldman, Marlene B; Chen, Dafang; Aitken, Iain W; Willett, Walter C; Selhub, Jacob; Xu, Xiping

2002-07-01

To assess the association between preconception homocysteine and B vitamin status and risk of clinical spontaneous abortion in women from Anqing, China. All women were aged 21-34 years, had never smoked, and were primigravid. Patients (n = 49) were women with a clinically recognized pregnancy who experienced a fetal death before 100 days' gestation. Controls (n = 409) were women who maintained a pregnancy that ended in a live birth. Homocysteine, folate, and vitamins B(6) and B(12) concentrations were measured in plasma obtained before conception. Mean vitamin B(6) concentration was lower in patients than in controls (34.0 versus 37.9 nmol/L, P =.04). In addition, the risk of spontaneous abortion tended to increase with decreasing plasma vitamin B(6) and folate concentration (P for trend =.06 and.07, respectively), although the significance of these trends was further reduced in logistic models that included age, body mass index, and both vitamins. The risk of spontaneous abortion was four-fold higher among women with suboptimal plasma concentrations of both folate and vitamin B(6) (folate less than or equal to 8.4 nmol/L and vitamin B(6) less than or equal to 49 nmol/L) than in those with higher plasma concentrations of both vitamins (odds ratio 4.1, 95% confidence interval 1.2, 14.4). Homocysteine and vitamin B(12) status were not associated with spontaneous abortion risk. Suboptimal preconception folate and vitamin B(6) status, especially when they occur together, may increase the risk of clinical spontaneous abortion. Additional prospective studies are needed to confirm these findings and to determine whether antenatal B vitamin supplementation reduces spontaneous abortion risk.

Bringing explicit insight into cognitive psychology features during clinical reasoning seminars: a prospective, controlled study.

PubMed

Nendaz, Mathieu R; Gut, Anne M; Louis-Simonet, Martine; Perrier, Arnaud; Vu, Nu V

2011-04-01

Facets of reasoning competence influenced by an explicit insight into cognitive psychology features during clinical reasoning seminars have not been specifically explored. This prospective, controlled study, conducted at the University of Geneva Faculty of Medicine, Switzerland, assessed the impact on sixth-year medical students' patient work-up of case-based reasoning seminars, bringing them explicit insight into cognitive aspects of their reasoning. Volunteer students registered for our three-month Internal Medicine elective were assigned to one of two training conditions: standard (control) or modified (intervention) case-based reasoning seminars. These seminars start with the patient's presenting complaint and the students must ask the tutor for additional clinical information to progress through case resolution. For this intervention, the tutors made each step explicit to students and encouraged self-reflection on their reasoning processes. At the end of their elective, students' performances were assessed through encounters with two standardized patients and chart write-ups. Twenty-nine students participated, providing a total of 58 encounters. The overall differences in accuracy of the final diagnosis given to the patient at the end of the encounter (control 63% vs intervention 74%, p = 0.53) and of the final diagnosis mentioned in the patient chart (61% vs 70%, p = 0.58) were not statistically significant. The students in the intervention group significantly more often listed the correct diagnosis among the differential diagnoses in their charts (75% vs 97%, p = 0.02). This case-based clinical reasoning seminar intervention, designed to bring students insight into cognitive features of their reasoning, improved aspects of diagnostic competence.

Combination of a fusogenic glycoprotein, prodrug activation, and oncolytic herpes simplex virus for enhanced local tumor control.

PubMed

Simpson, Guy R; Han, Ziqun; Liu, Binlei; Wang, Yibing; Campbell, Gregor; Coffin, Robert S

2006-05-01

We have previously developed an oncolytic herpes simplex virus-1 based on a clinical virus isolate, which was deleted for ICP34.5 to provide tumor selected replication and ICP47 to increase antigen presentation as well as tumor selective virus replication. A phase I/II clinical trial using a version of this virus expressing granulocyte macrophage colony-stimulating factor has shown promising results. The work reported here aimed to develop a version of this virus in which local tumor control was further increased through the combined expression of a highly potent prodrug activating gene [yeast cytosine deaminase/uracil phospho-ribosyltransferase fusion (Fcy::Fur)] and the fusogenic glycoprotein from gibbon ape leukemia virus (GALV), which it was hoped would aid the spread of the activated prodrug through the tumor. Viruses expressing the two genes individually or in combination were constructed and tested, showing (a) GALV and/or Fcy::Fur expression did not affect virus growth; (b) GALV expression causes cell fusion and increases the tumor cell killing at least 30-fold in vitro and tumor shrinkage 5- to 10-fold in vivo; (c) additional expression of Fcy::Fur combined with 5-fluorocytosine administration improves tumor shrinkage further. These results indicate, therefore, that the combined expression of the GALV protein and Fcy::Fur provides a highly potent oncolytic virus with improved capabilities for local tumor control. It is intended to enter the GALV/Fcy::Fur expressing virus into clinical development for the treatment of tumor types, such as pancreatic or lung cancer, where local control would be anticipated to be clinically advantageous.

Hypnotherapy of a pain disorder: a clinical case study.

PubMed

Artimon, Henrieta Mihaela

2015-01-01

Hypnotherapy's effectiveness in improving and controlling chronic pain of various etiologies has been demonstrated by studies; the mechanism by which hypnosis does this is more complex than a simple induction of muscle relaxation. This study reveals, in addition to this mechanism, a deeper dimension of hypnotherapy from the vantage of a patient with a medical-surgical background, diagnosed with a pain disorder and major severe depressive disorder in addition to incurable painful symptoms, through treatment associated with hypnoanalysis. Following psychotherapy, which included some elements of cognitive-behavioral therapy, a complete remission of the anxious-depressive mood and the painful symptoms was achieved.

Additive manufacturing: From implants to organs.

PubMed

Douglas, Tania S

2014-05-12

Additive manufacturing (AM) constructs 3D objects layer by layer under computer control from 3D models. 3D printing is one example of this kind of technology. AM offers geometric flexibility in its products and therefore allows customisation to suit individual needs. Clinical success has been shown with models for surgical planning, implants, assistive devices and scaffold-based tissue engineering. The use of AM to print tissues and organs that mimic nature in structure and function remains an elusive goal, but has the potential to transform personalised medicine, drug development and scientific understanding of the mechanisms of disease. 

The Role of Liuwei Dihuang Pills and Ginkgo Leaf Tablets in Treating Diabetic Complications.

PubMed

Zhao, Yue; Yu, Jiangyi; Liu, Jingshun; An, Xiaofei

2016-01-01

Objective. To observe the clinical prophylactic and therapeutic efficacy of Liuwei Dihuang Pills and Ginkgo Leaf Tablets for type 2 diabetic vascular complications. Methods. It was a randomized, double-blind and placebo-controlled clinical trial. 140 outpatients with type 2 diabetes were recruited and randomly divided into the treatment group and control group. The two groups were given basic therapy (management of blood sugar, blood pressure, etc.). Additionally, the treatment group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets, while the control group was given Liuwei Dihuang Pills and Ginkgo Leaf Tablets placebos. All subjects were followed up for consecutive 36 months and observed monthly. The clinical data as urinary microalbumin to urinary creatinine ratio (Umalb/cr), carotid intima-media thickness (IMT), diabetic nephropathy (DN) and diabetic retinopathy (DR) prevalence, cardiovascular and cerebrovascular events, blood glucose, and blood pressure were collected and analyzed statistically. Results. After 36-month treatment, the Umalb/cr level and DN and DR prevalence in treatment group were all significantly lower than control group ( P < 0.05). However, the IMT level and the incidence of cardiovascular and cerebrovascular events were not significantly different between the two groups ( P > 0.05). Conclusions. Liuwei Dihuang Pills and Ginkgo Leaf Tablets are beneficial to diabetic microvascular complications, while the efficacy to diabetic macrovascular complications needs more observations.

Consequences of anorectal cancer atlas implementation in the cooperative group setting: radiobiologic analysis of a prospective randomized in silico target delineation study.

PubMed

Mavroidis, Panayiotis; Giantsoudis, Drosoula; Awan, Musaddiq J; Nijkamp, Jasper; Rasch, Coen R N; Duppen, Joop C; Thomas, Charles R; Okunieff, Paul; Jones, William E; Kachnic, Lisa A; Papanikolaou, Niko; Fuller, Clifton D

2014-09-01

The aim of this study is to ascertain the subsequent radiobiological impact of using a consensus guideline target volume delineation atlas. Using a representative case and target volume delineation instructions derived from a proposed IMRT rectal cancer clinical trial, gross tumor volume (GTV) and clinical/planning target volumes (CTV/PTV) were contoured by 13 physician observers (Phase 1). The observers were then randomly assigned to follow (atlas) or not-follow (control) a consensus guideline/atlas for anorectal cancers, and instructed to re-contour the same case (Phase 2). The atlas group was found to have increased tumor control probability (TCP) after the atlas intervention for both the CTV (p<0.0001) and PTV1 (p=0.0011) with decreasing normal tissue complication probability (NTCP) for small intestine, while the control group did not. Additionally, the atlas group had reduced variance in TCP for all target volumes and reduced variance in NTCP for the bowel. In Phase 2, the atlas group had increased TCP relative to the control for CTV (p=0.03). Visual atlas and consensus treatment guideline usage in the development of rectal cancer IMRT treatment plans reduced the inter-observer radiobiological variation, with clinically relevant TCP alteration for CTV and PTV volumes. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Pathogen-free, plasma-poor platelet lysate and expansion of human mesenchymal stem cells.

PubMed

Iudicone, Paola; Fioravanti, Daniela; Bonanno, Giuseppina; Miceli, Michelina; Lavorino, Claudio; Totta, Pierangela; Frati, Luigi; Nuti, Marianna; Pierelli, Luca

2014-01-27

Supplements to support clinical-grade cultures of mesenchymal stem cells (MSC) are required to promote growth and expansion of these cells. Platelet lysate (PL) is a human blood component which may replace animal serum in MSC cultures being rich in various growth factors. Here, we describe a plasma poor pathogen-free platelet lysate obtained by pooling 12 platelet (PLT) units, to produce a standardized and safe supplement for clinical-grade expansion of MSC. PL lots were obtained by combining 2 6-unit PLT pools in additive solution (AS) following a transfusional-based procedure including pathogen inactivation (PI) by Intercept technology and 3 cycles of freezing/thawing, followed by membrane removal. Three PI-PL and 3 control PL lots were produced to compare their ability to sustain bone marrow derived MSC selection and expansion. Moreover, two further PL, subjected to PI or not, were also produced starting from the same initial PLT pools to evaluate the impact of PI on growth factor concentration and capacity to sustain cell growth. Additional PI-PL lots were used for comparison with fetal bovine serum (FBS) on MSC expansion. Immunoregulatory properties of PI-PL-generated MSC were documented in vitro by mixed lymphocyte culture (MLC) and peripheral blood mononuclear cells (PBMC) mitogen induced proliferation. PI-PL and PL control lots had similar concentrations of 4 well-described growth factors endowed with MSC stimulating ability. Initial growth and MSC expansion by PI-PL and PL controls were comparable either using different MSC populations or in head to head experiments. Moreover, PI-PL and PL control sustained similar MSC growth of frozen/thawed MSC. Multilineage differentiation of PI-derived and PI-PL-derived MSC were maintained in any MSC cultures as well as their immunoregulatory properties. Finally, no direct impact of PI on growth factor concentration and MSC growth support was observed, whereas the capacity of FBS to sustain MSC expansion in basic medium was irrelevant as compared to PL and PI-PL. The replacement of animal additives with human supplements is a basic issue in MSC ex vivo production. PI-PL represents a standardized, plasma-poor, human preparation which appears as a safe and good candidate to stimulate MSC growth in clinical-scale cultures.

Pathogen-free, plasma-poor platelet lysate and expansion of human mesenchymal stem cells

PubMed Central

2014-01-01

Background Supplements to support clinical-grade cultures of mesenchymal stem cells (MSC) are required to promote growth and expansion of these cells. Platelet lysate (PL) is a human blood component which may replace animal serum in MSC cultures being rich in various growth factors. Here, we describe a plasma poor pathogen-free platelet lysate obtained by pooling 12 platelet (PLT) units, to produce a standardized and safe supplement for clinical-grade expansion of MSC. Methods PL lots were obtained by combining 2 6-unit PLT pools in additive solution (AS) following a transfusional-based procedure including pathogen inactivation (PI) by Intercept technology and 3 cycles of freezing/thawing, followed by membrane removal. Three PI-PL and 3 control PL lots were produced to compare their ability to sustain bone marrow derived MSC selection and expansion. Moreover, two further PL, subjected to PI or not, were also produced starting from the same initial PLT pools to evaluate the impact of PI on growth factor concentration and capacity to sustain cell growth. Additional PI-PL lots were used for comparison with fetal bovine serum (FBS) on MSC expansion. Immunoregulatory properties of PI-PL-generated MSC were documented in vitro by mixed lymphocyte culture (MLC) and peripheral blood mononuclear cells (PBMC) mitogen induced proliferation. Results PI-PL and PL control lots had similar concentrations of 4 well-described growth factors endowed with MSC stimulating ability. Initial growth and MSC expansion by PI-PL and PL controls were comparable either using different MSC populations or in head to head experiments. Moreover, PI-PL and PL control sustained similar MSC growth of frozen/thawed MSC. Multilineage differentiation of PI-derived and PI-PL-derived MSC were maintained in any MSC cultures as well as their immunoregulatory properties. Finally, no direct impact of PI on growth factor concentration and MSC growth support was observed, whereas the capacity of FBS to sustain MSC expansion in basic medium was irrelevant as compared to PL and PI-PL. Conclusion The replacement of animal additives with human supplements is a basic issue in MSC ex vivo production. PI-PL represents a standardized, plasma-poor, human preparation which appears as a safe and good candidate to stimulate MSC growth in clinical-scale cultures. PMID:24467837

Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study.

PubMed

Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

2015-01-01

Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p < 0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs' abilities to apply EBP knowledge and skills when supervising students.

Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study

PubMed Central

Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

2015-01-01

Background and Purpose Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. Methods We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. Results In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p<0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. Conclusions A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs’ abilities to apply EBP knowledge and skills when supervising students. PMID:25894559

Effects of aerobic dance training on blood pressure in individuals with uncontrolled hypertension on two antihypertensive drugs: a randomized clinical trial.

PubMed

Maruf, Fatai Adesina; Akinpelu, Aderonke Omobonike; Salako, Babatunde Lawal; Akinyemi, Joshua Odunayo

2016-04-01

There is a dearth of reports on possible additive blood pressure (BP)-reducing effect of aerobic exercise on antihypertensive drug in humans. This study investigated the additive BP-reducing effect of aerobic exercise on BP in individuals with uncontrolled hypertension. In this 12-week double-blind study, 120 new-diagnosed individuals with mild-to-moderate hypertension were randomized to receive coamilozide + 5/10 mg of amlodipine + aerobic dance or coamilozide + 5/10 mg of amlodipine alone. Forty-five and 43 participants in exercise and control groups, respectively, completed the 12-week intervention. Addition of aerobic exercise to antihypertensive drug therapy significantly reduced systolic BP (7.1 mm Hg [95% confidence interval: 5.0, 9.3]; P < .001) and diastolic BP (1.7 mm Hg [95% confidence interval: 0.4, 3.0]; P = .009) at 12 weeks. BP control rate differed significantly between exercise (53.9%) and control (35.3%) groups, P < .001. Postintervention, proportion of participants in exercise group who had their number of antihypertensive drug reduced to one (20.3%) differed from that in control group (11.1%); (χ(2) = 11.0; P = .001). Combination of aerobic dance and antihypertensive drugs reduces number of antihypertensive drugs needed to achieve BP control and enhances BP control in individuals with hypertension on two antihypertensive drugs. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

Predictive factors for the placebo effect in clinical trials for dry eye: a pooled analysis of three clinical trials.

PubMed

Imanaka, Takahiro; Sato, Izumi; Tanaka, Shiro; Kawakami, Koji

2017-11-01

Placebo effect is one of the methodological difficulties in dry eye clinical trials. If we could elucidate the tendencies of the placebo response and find predictors, we could reduce the placebo response in clinical trials for dry eye. In this study, we investigated the predictive factors for the placebo effect in dry eye clinical trials. A total of 205 patients with dry eye assigned to the placebo arms of three placebo-controlled randomised clinical trials were analysed by simple and multivariable regression analysis. The corneal fluorescein (FL) staining score and dry eye symptoms were studied at week 4. The variables of interest included gender, age, complications of Sjögren's syndrome, Schirmer's test I value, tear break-up time and conjunctival hyperaemia score. We also conducted a stratified analysis according to the patients' age. Among all the studied endpoints, the baseline scores were significantly related to the corresponding placebo response. In addition, for the FL score and the dryness score, age was a significant predictor of the placebo response (p=0.04 and p<0.0001, respectively). Stratified analysis by age showed that patients more than 40 years of age are more likely to have a stronger placebo response in the FL and dryness scores. The baseline scores and age were predictive factors of the placebo response in frequently used endpoints, such as FL score or dryness symptoms. These patient characteristics can be controlled by study design, and our findings enable the design of more efficient placebo-controlled studies with good statistical power. © 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.

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

PubMed

Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

2017-04-21

Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

Human Heredity and Health (H3) in Africa Kidney Disease Research Network: A Focus on Methods in Sub-Saharan Africa.

PubMed

Osafo, Charlotte; Raji, Yemi Raheem; Burke, David; Tayo, Bamidele O; Tiffin, Nicki; Moxey-Mims, Marva M; Rasooly, Rebekah S; Kimmel, Paul L; Ojo, Akinlolu; Adu, Dwomoa; Parekh, Rulan S

2015-12-07

CKD affects an estimated 14% of adults in sub-Saharan Africa, but very little research has been done on the cause, progression, and prevention of CKD there. As part of the Human Heredity and Health in Africa (H3Africa) Consortium, the H3Africa Kidney Disease Research Network was established to study prevalent forms of kidney disease in sub-Saharan Africa and increase the capacity for genetics and genomics research. The study is performing comprehensive phenotypic characterization and analyzing environmental and genetic factors from nine clinical centers in four African countries (Ghana, Nigeria, Ethiopia, and Kenya) over a 5-year period. Approximately 4000 participants with specified kidney disease diagnoses and 4000 control participants will be enrolled in the four African countries. In addition, approximately 50 families with hereditary glomerular disease will be enrolled. The study includes both pediatric and adult participants age <1 to 74 years across a broad spectrum of kidney diseases secondary to hypertension-attributed nephropathy, diabetes, HIV infection, sickle cell disease, biopsy-proven glomerular disease, and CKD of unknown origin. Clinical and demographic data with biospecimens are collected to assess clinical, biochemical, and genetic markers of kidney disease. As of March 2015, a total of 3499 patients and controls have been recruited and 1897 had complete entry data for analysis. Slightly more than half (50.2%) of the cohort is female. Initial quality control of clinical data collection and of biosample and DNA analysis is satisfactory, demonstrating that a clinical research infrastructure can be successfully established in Africa. This study will provide clinical, biochemical, and genotypic data that will greatly increase the understanding of CKD in sub-Saharan Africa. Copyright © 2015 by the American Society of Nephrology.

Can near-peer medical students effectively teach a new curriculum in physical examination?

PubMed Central

2013-01-01

Background Students in German medical schools frequently complain that the subject ‘clinical examination’ is not taught in a satisfying manner due to time constraints and lack of personnel resources. While the effectiveness and efficiency of practice-oriented teaching in small groups using near-peer teaching has been shown, it is rarely used in German medical schools. We investigated whether adding a new near-peer teaching course developed with student input plus patient examination under supervision in small groups improves basic clinical examination skills in third year medical students compared to a traditional clinical examination course alone. Methods Third year medical students registered for the mandatory curricular clinical examination course at the medical faculty of the Technische Universität München were invited to participate in a randomised trial with blinded outcome assessment. Students were randomised to the control group participating in the established curricular physical examination course or to the intervention group, which received additional near-peer teaching for the same content. The learning success was verified by a voluntary objective structured clinical examination (OSCE). Results A total of 84 students were randomised and 53 (63%) participated in the final OSCE. Students in the control group scored a median of 57% (25th percentile 47%, 75th percentile 61%) of the maximum possible total points of the OSCE compared to 77% (73%, 80%; p < 0.001) for students in the intervention group. Only two students in the intervention group received a lower score than the best student in the control group. Conclusion Adding a near-peer teaching course to the routine course significantly improved the clinical examination skills of medical students in an efficient manner in the context of a resource-constrained setting. PMID:24325639

Outbreak of Pneumocystis jirovecii Infection among Heart Transplant Recipients: Molecular Investigation and Management of an Inter-human Transmission.

PubMed

Vindrios, William; Argy, Nicolas; Le Gal, Solène; Lescure, François-Xavier; Massias, Laurent; Le, Minh Patrick; Wolff, Michel; Yazdanpanah, Yazdan; Nevez, Gilles; Houze, Sandrine; Dorent, Richard; Lucet, Jean-Christophe

2017-05-26

An outbreak of Pneumocystis jirovecii pneumonia (PCP) occurred among heart transplant recipients (HTR) at the outpatient clinic of a university hospital, from March to September 2015. Clinical, therapeutic, biological and molecular data were analyzed to determine its origin and control the outbreak. Clinical and biological data regarding all HTR followed in the outpatient clinic were collected. PCP diagnosis was based on microscopy and real-time PCR. Investigations were performed by building a transmission map, completed by genotyping Pneumocystis isolates and by a control of chemoprophylaxis observance. Asymptomatic exposed patients were screened for colonisation using real-time PCR. Among 124 HTR, 7 PCP cases were confirmed. Screening identified three additional patients colonized by Pneumocystis jirovecii. All patients were cured and no further cases were identified after that trimethoprim-sulfamethoxazole prophylaxis was introduced in the entire cohort. Genotyping demonstrated the same strain in all PCP cases and colonized patients. All cases were linked with possible transmission chains from 2 possible index patients. Inter-human transmission was significantly associated with more frequent visits in the outpatient clinic. Six cases were receiving atovaquone as a prophylaxis. The occurrence of PCP was significantly associated with atovaquone prophylaxis. This is the first outbreak with detailed molecular analysis in HTR so far. Genotyping and transmission chain confirmed the inter-human transmission in all colonized/infected PCP cases. Outpatient clinic layout and high encounters probably caused this PCP cluster, which was controlled after systematic trimethoprim-sulfamethoxazole prophylaxis in exposed patients. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Robot-Aided Neurorehabilitation: A Robot for Wrist Rehabilitation

PubMed Central

Krebs, Hermano Igo; Volpe, Bruce T.; Williams, Dustin; Celestino, James; Charles, Steven K.; Lynch, Daniel; Hogan, Neville

2009-01-01

In 1991, a novel robot, MIT-MANUS, was introduced to study the potential that robots might assist in and quantify the neuro-rehabilitation of motor function. MIT-MANUS proved an excellent tool for shoulder and elbow rehabilitation in stroke patients, showing in clinical trials a reduction of impairment in movements confined to the exercised joints. This successful proof of principle as to additional targeted and intensive movement treatment prompted a test of robot training examining other limb segments. This paper focuses on a robot for wrist rehabilitation designed to provide three rotational degrees-of-freedom. The first clinical trial of the device will enroll 200 stroke survivors. Ultimately 160 stroke survivors will train with both the proximal shoulder and elbow MIT-MANUS robot, as well as with the novel distal wrist robot, in addition to 40 stroke survivor controls. So far 52 stroke patients have completed the robot training (ongoing protocol). Here, we report on the initial results on 36 of these volunteers. These results demonstrate that further improvement should be expected by adding additional training to other limb segments. PMID:17894265

The implication of combat-induced stress reaction, PTSD, and attachment in parenting among war veterans.

PubMed

Cohen, Estee; Zerach, Gadi; Solomon, Zahava

2011-10-01

This study examined parental functioning, parental satisfaction, and concern for offspring during their child's military service, among war veterans, some of whom suffered from acute combat-induced stress reaction (CSR) and posttraumatic stress disorder (PTSD). In addition, we examined the additive and interactive contributions of CSR, PTSD and attachment dimensions to parenting measures. The sample consisted of 477 participants divided into two groups: a clinical group of veterans who had been diagnosed with CSR on the battlefield (N = 267), and a matched control group of veterans who did not suffer from CSR (NCSR; N = 210). CSR, PTSD, avoidant-attachment, and anxious-attachment, were all related to lower levels of parental functioning and satisfaction. Veterans who suffered from both CSR and PTSD reported more concern for their offspring during their child's military service compared to veterans with PTSD but without antecedent CSR. Attachment dimensions and specifically attachment-avoidance, made the greatest contribution to parenting measures, followed by posttraumatic symptoms. In addition, attachment-avoidance moderated the relationship between posttraumatic symptoms and parental functioning. Theoretical and clinical implications of these results are discussed.

Robot-aided neurorehabilitation: a robot for wrist rehabilitation.

PubMed

Krebs, Hermano Igo; Volpe, Bruce T; Williams, Dustin; Celestino, James; Charles, Steven K; Lynch, Daniel; Hogan, Neville

2007-09-01

In 1991, a novel robot, MIT-MANUS, was introduced to study the potential that robots might assist in and quantify the neuro-rehabilitation of motor function. MIT-MANUS proved an excellent tool for shoulder and elbow rehabilitation in stroke patients, showing in clinical trials a reduction of impairment in movements confined to the exercised joints. This successful proof of principle as to additional targeted and intensive movement treatment prompted a test of robot training examining other limb segments. This paper focuses on a robot for wrist rehabilitation designed to provide three rotational degrees-of-freedom. The first clinical trial of the device will enroll 200 stroke survivors. Ultimately 160 stroke survivors will train with both the proximal shoulder and elbow MIT-MANUS robot, as well as with the novel distal wrist robot, in addition to 40 stroke survivor controls. So far 52 stroke patients have completed the robot training (ongoing protocol). Here, we report on the initial results on 36 of these volunteers. These results demonstrate that further improvement should be expected by adding additional training to other limb segments.

Burnout and Hypocortisolism - A Matter of Severity? A Study on ACTH and Cortisol Responses to Acute Psychosocial Stress.

PubMed

Lennartsson, Anna-Karin; Sjörs, Anna; Währborg, Peter; Ljung, Thomas; Jonsdottir, Ingibjörg H

2015-01-01

Common consequences of long-term psychosocial stress are fatigue and burnout. It has been suggested that burnout could be associated with hypocortisolism, thus, inability to produce sufficient amounts of cortisol. This study aimed to investigate whether patients with clinical burnout exhibit aberrant ACTH and cortisol responses under acute psychosocial stress compared with healthy individuals. Nineteen patients (9 men and 10 women) and 37 healthy subjects (20 men and 17 women), underwent the Trier Social Stress Test. Blood samples and saliva samples were collected before, after, and during the stress test for measurements of plasma ACTH, serum cortisol, and salivary cortisol. Several statistical analyses were conducted to compare the responses between patients and controls. In addition, in order to investigate the possibility that burnout patients with more severe symptoms would respond differently, sub-groups of patients reporting higher and lower burnout scores were compared. In both patients and healthy controls, we observed elevated levels of ACTH and cortisol after exposure to the stressor. There were no differences in responses of ACTH, serum cortisol, or salivary cortisol between patients and controls. Patients reporting higher burnout scores had lower salivary cortisol responses than controls, indicating that patients with more severe burnout symptoms may be suffering from hypocortisolism. In addition, patients with more severe burnout symptoms tended to have smaller ACTH responses than the other patients. However, there was no corresponding difference in serum cortisol. This study indicates that hypocortisolism is not present in a clinical burnout patient group as a whole but may be present in the patients with more severe burnout symptoms.

Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up.

PubMed

Ris, I; Søgaard, K; Gram, B; Agerbo, K; Boyle, E; Juul-Kristensen, B

2016-12-01

To investigate the effect of combining pain education, specific exercises and graded physical activity training (exercise) compared with pain education alone (control) on physical health-related quality of life (HR-QoL) in chronic neck pain patients. A multicentre randomised controlled trial of 200 neck pain patients receiving pain education. The exercise group received additional exercises for neck/shoulder, balance and oculomotor function, plus graded physical activity training. Patient-reported outcome measures (Short Form-36 Physical and Mental component summary scores, EuroQol-5D, Beck Depression Inventory-II, Neck Disability Index, Pain Bothersomeness, Patient-Specific Functioning Scale, Tampa Scale of Kinesiophobia, Global Perceived Effect) and clinical tests (Aastrand Physical Fitness, cervical Range of Motion, Pressure Pain Threshold at infraspinatus, tibialis anterior and cervical spine, Cranio-cervical Flexion, Cervical Extension muscle function, and oculomotion) were recorded at baseline and after 4 months. The exercise group showed statistically significant improvement in physical HR-QoL, mental HR-QoL, depression, cervical pressure pain threshold, cervical extension movement, muscle function, and oculomotion. Per protocol analyses confirmed these results with additional significant improvements in the exercise group compared with controls. This multimodal intervention may be an effective intervention for chronic neck pain patients. The trial was registered on www.ClinicalTrials.govNCT01431261 and at the Regional Scientific Ethics Committee of Southern Denmark S-20100069. Copyright © 2016 Elsevier Ltd. All rights reserved.

Email for clinical communication between healthcare professionals.

PubMed

Goyder, Clare; Atherton, Helen; Car, Mate; Heneghan, Carl J; Car, Josip

2015-02-20

Email is one of the most widely used methods of communication, but its use in healthcare is still uncommon. Where email communication has been utilised in health care, its purposes have included clinical communication between healthcare professionals, but the effects of using email in this way are not well known. We updated a 2012 review of the use of email for two-way clinical communication between healthcare professionals. To assess the effects of email for clinical communication between healthcare professionals on healthcare professional outcomes, patient outcomes, health service performance, and service efficiency and acceptability, when compared to other forms of communicating clinical information. We searched: the Cochrane Consumers and Communication Review Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 9 2013), MEDLINE (OvidSP) (1946 to August 2013), EMBASE (OvidSP) (1974 to August 2013), PsycINFO (1967 to August 2013), CINAHL (EbscoHOST) (1982 to August 2013), and ERIC (CSA) (1965 to January 2010). We searched grey literature: theses/dissertation repositories, trials registers and Google Scholar (searched November 2013). We used additional search methods: examining reference lists and contacting authors. Randomised controlled trials, quasi-randomised trials, controlled before and after studies, and interrupted time series studies examining interventions in which healthcare professionals used email for communicating clinical information in the form of: 1) unsecured email, 2) secure email, or 3) web messaging. All healthcare professionals, patients and caregivers in all settings were considered. Two authors independently assessed studies for inclusion, assessed the included studies' risk of bias, and extracted data. We contacted study authors for additional information and have reported all measures as per the study report. The previous version of this review included one randomised controlled trial involving 327 patients and 159 healthcare providers at baseline. It compared an email to physicians containing patient-specific osteoporosis risk information and guidelines for evaluation and treatment versus usual care (no email). This study was at high risk of bias for the allocation concealment and blinding domains. The email reminder changed health professional actions significantly, with professionals more likely to provide guideline-recommended osteoporosis treatment (bone density measurement or osteoporosis medication, or both) when compared with usual care. The evidence for its impact on patient behaviours or actions was inconclusive. One measure found that the electronic medical reminder message impacted patient behaviour positively (patients had a higher calcium intake), and two found no difference between the two groups. The study did not assess health service outcomes or harms.No new studies were identified for this update. Only one study was identified for inclusion, providing insufficient evidence for guiding clinical practice in regard to the use of email for clinical communication between healthcare professionals. Future research should aim to utilise high-quality study designs that use the most recent developments in information technology, with consideration of the complexity of email as an intervention.

Email for clinical communication between healthcare professionals.

PubMed

Pappas, Yannis; Atherton, Helen; Sawmynaden, Prescilla; Car, Josip

2012-09-12

Email is a popular and commonly-used method of communication, but its use in healthcare is not routine. Where email communication has been utilised in health care, its purposes have included use for clinical communication between healthcare professionals, but the effects of using email in this way are not known. This review assesses the use of email for two-way clinical communication between healthcare professionals. To assess the effects of healthcare professionals using email to communicate clinical information, on healthcare professional outcomes, patient outcomes, health service performance, and service efficiency and acceptability, when compared to other forms of communicating clinical information. We searched: the Cochrane Consumers and Communication Review Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1 2010), MEDLINE (OvidSP) (1950 to January 2010), EMBASE (OvidSP) (1980 to January 2010), PsycINFO (1967 to January 2010), CINAHL (EbscoHOST) (1982 to February 2010), and ERIC (CSA) (1965 to January 2010). We searched grey literature: theses/dissertation repositories, trials registers and Google Scholar (searched July 2010). We used additional search methods: examining reference lists, contacting authors. Randomised controlled trials, quasi-randomised trials, controlled before and after studies and interrupted time series studies examining interventions in which healthcare professionals used email for communicating clinical information, and that took the form of 1) unsecured email 2) secure email or 3) web messaging. All healthcare professionals, patients and caregivers in all settings were considered. Two authors independently assessed studies for inclusion, assessed the included studies' risk of bias, and extracted data. We contacted study authors for additional information. We report all measures as per the study report. We included one randomised controlled trial involving 327 patients and 159 healthcare providers at baseline. It compared an email to physicians containing patient-specific osteoporosis risk information and guidelines for evaluation and treatment with usual care (no email). This study was at high risk of bias for the allocation concealment and blinding domains. The email reminder changed health professional actions significantly, with professionals more likely to provide guideline-recommended osteoporosis treatment (bone density measurement and/or osteoporosis medication) when compared with usual care. The evidence for its impact on patient behaviours/actions was inconclusive. One measure found that the electronic medical reminder message impacted patient behaviour positively: patients had a higher calcium intake, and two found no difference between the two groups. The study did not assess primary health service outcomes or harms. As only one study was identified for inclusion, the results are inadequate to inform clinical practice in regard to the use of email for clinical communication between healthcare professionals. Future research needs to use high-quality study designs that take advantage of the most recent developments in information technology, with consideration of the complexity of email as an intervention, and costs.

Influence of clinical baseline findings on the survival of 2 post systems: a randomized clinical trial.

PubMed

Schmitter, Marc; Rammelsberg, Peter; Gabbert, Olaf; Ohlmann, Brigitte

2007-01-01

The aim of this prospective randomized controlled trial was to evaluate the influence of clinical baseline characteristics on the survival of 2 post systems. One hundred patients needing a post were included. Half the patients received a glass fiber-reinforced post (FRP), and the other half received metal screw posts (MSP). The posts were assigned randomly. In addition to demographic data, the following parameters were recorded: type of tooth (incisor/canine versus molar/premolar), length of the post in relation to root length (percentage), extent of coronal tooth destruction (percentage), ferrule height (in millimeters), type of restoration (fixed or removable partial denture), and presence of antagonistic contacts (yes/no). After at least 1 year (mean: 13.84 months), the patients were recalled. Statistical analysis was performed using the log-rank test and Cox regression analysis. The survival rate of FRPs was 93.5%. In the MSP group, the survival rate was significantly lower (75.6%; log-rank test, P = .049). Additionally, the metal posts were associated with more unfavorable complications, for example, root fracture. The type of the tooth and the degree of coronal tooth destruction influenced the survival of MSPs, whereas no influence of these variables could be seen for FRPs. FRPs are superior to MSPs with respect to short-term clinical performance. Especially for MSPs, clinical survival depends on several variables.

Impact of a complex chronic care patient case conference on quality and utilization.

PubMed

Weppner, William G; Davis, Kyle; Tivis, Rick; Willis, Janet; Fisher, Amber; King, India; Smith, C Scott

2018-05-23

There is need for effective venues to allow teams to coordinate care for high-risk or high-need patients. In addition, health systems need to assess the impact of such approaches on outcomes related to chronic health conditions and patient utilization. We evaluate the clinical impact of a novel case conference involving colocated trainees and supervisors in an interprofessional academic primary care clinic. The study utilized a prospective cohort with control group. Intervention patients (N = 104) were matched with controls (N = 104) from the same provider's panel using propensity scores based on age, gender, risk predictors, and prior utilization patterns. Clinical outcomes and subsequent utilization patterns were compared prior to and up to 6 months following the conference. In terms of utilization, intervention patients demonstrated increased visits with primary care team members (p = .0002) compared with controls, without a corresponding increase in the number of primary care providers' visits. There was a trend towards decreased urgent care and emergency visits (p = .07) and a significant decrease in the rate of hospitalizations (p = .04). Patients with poorly-controlled hypertension saw significant decreases in mean systolic blood pressure from 167 to 146 mm Hg. However, there were no differences between the intervention and control groups. Intervention patients with diabetes demonstrated a nonsignificant trend towards decreased hemoglobin A1c from 9.8 to 9.4, when compared with controls. Interprofessional case conferences have potential to improve care coordination and may be associated with improved disease management, decreased unplanned care, and overall reduced hospitalizations.

Rapid Automatized Naming in Children with Dyslexia: Is Inhibitory Control Involved?

PubMed

Bexkens, Anika; van den Wildenberg, Wery P M; Tijms, Jurgen

2015-08-01

Rapid automatized naming (RAN) is widely seen as an important indicator of dyslexia. The nature of the cognitive processes involved in rapid naming is however still a topic of controversy. We hypothesized that in addition to the involvement of phonological processes and processing speed, RAN is a function of inhibition processes, in particular of interference control. A total 86 children with dyslexia and 31 normal readers were recruited. Our results revealed that in addition to phonological processing and processing speed, interference control predicts rapid naming in dyslexia, but in contrast to these other two cognitive processes, inhibition is not significantly associated with their reading and spelling skills. After variance in reading and spelling associated with processing speed, interference control and phonological processing was partialled out, naming speed was no longer consistently associated with the reading and spelling skills of children with dyslexia. Finally, dyslexic children differed from normal readers on naming speed, literacy skills, phonological processing and processing speed, but not on inhibition processes. Both theoretical and clinical interpretations of these results are discussed. Copyright © 2014 John Wiley & Sons, Ltd.

Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery.

PubMed

Sujata, Nambiath; Tobin, Raj; Kaur, Ranjeet; Aneja, Anjila; Khanna, Mona; Hanjoora, Vijay M

2016-06-01

To assess the effects of tranexamic acid among patients undergoing cesarean delivery who were at high risk of postpartum hemorrhage. Between August 1, 2012, and April 30, 2013, a randomized controlled trial was performed at a tertiary care center in India. Women undergoing an elective or emergency cesarean delivery who were at high risk for postpartum hemorrhage were enrolled. They were randomly assigned using sealed, opaque envelopes to receive 10mg/kg tranexamic acid or normal saline 10min before skin incision. Anesthesiologists were not masked to group assignment, but patients and obstetricians were. The primary outcome was need for additional uterotonic drugs within 24h after delivery. Analyses were by intention to treat. Thirty patients were assigned to each group. Additional uterotonic drugs were required in 7 (23%) patients assigned to tranexamic acid and 25 (83%) patients in the control group (P<0.001). Intravenous tranexamic acid, administered before skin incision, significantly reduced the requirement for additional uterotonics among women at increased risk for postpartum hemorrhage. Clinical Trials Registry India: CTRI/2015/05/005752. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Identification of potential surgical site infections leveraging an enterprise clinical information warehouse.

PubMed

Santangelo, Jennifer; Erdal, Selnur; Wellington, Linda; Mekhjian, Hagop; Kamal, Jyoti

2008-11-06

At The Ohio State University Medical Center (OSUMC), infection control practitioners (ICPs) need an accurate list of patients undergoing defined operative procedures to track surgical site infections. Using data from the OSUMC Information Warehouse (IW), we have created an automated report detailing required data. This report also displays associated surgical and pathology text or dictated reports providing additional information to the ICPs.

Impact of a clinical decision model for febrile children at risk for serious bacterial infections at the emergency department: a randomized controlled trial.

PubMed

de Vos-Kerkhof, Evelien; Nijman, Ruud G; Vergouwe, Yvonne; Polinder, Suzanne; Steyerberg, Ewout W; van der Lei, Johan; Moll, Henriëtte A; Oostenbrink, Rianne

2015-01-01

To assess the impact of a clinical decision model for febrile children at risk for serious bacterial infections (SBI) attending the emergency department (ED). Randomized controlled trial with 439 febrile children, aged 1 month-16 years, attending the pediatric ED of a Dutch university hospital during 2010-2012. Febrile children were randomly assigned to the intervention (clinical decision model; n = 219) or the control group (usual care; n = 220). The clinical decision model included clinical symptoms, vital signs, and C-reactive protein and provided high/low-risks for "pneumonia" and "other SBI". Nurses were guided by the intervention to initiate additional tests for high-risk children. The clinical decision model was evaluated by 1) area-under-the-receiver-operating-characteristic-curve (AUC) to indicate discriminative ability and 2) feasibility, to measure nurses' compliance to model recommendations. Primary patient outcome was defined as correct SBI diagnoses. Secondary process outcomes were defined as length of stay; diagnostic tests; antibiotic treatment; hospital admission; revisits and medical costs. The decision model had good discriminative ability for both pneumonia (n = 33; AUC 0.83 (95% CI 0.75-0.90)) and other SBI (n = 22; AUC 0.81 (95% CI 0.72-0.90)). Compliance to model recommendations was high (86%). No differences in correct SBI determination were observed. Application of the clinical decision model resulted in less full-blood-counts (14% vs. 22%, p-value < 0.05) and more urine-dipstick testing (71% vs. 61%, p-value < 0.05). In contrast to our expectations no substantial impact on patient outcome was perceived. The clinical decision model preserved, however, good discriminatory ability to detect SBI, achieved good compliance among nurses and resulted in a more standardized diagnostic approach towards febrile children, with less full blood-counts and more rightfully urine-dipstick testing. Nederlands Trial Register NTR2381.

Impact of a Clinical Decision Model for Febrile Children at Risk for Serious Bacterial Infections at the Emergency Department: A Randomized Controlled Trial

PubMed Central

de Vos-Kerkhof, Evelien; Nijman, Ruud G.; Vergouwe, Yvonne; Polinder, Suzanne; Steyerberg, Ewout W.; van der Lei, Johan; Moll, Henriëtte A.; Oostenbrink, Rianne

2015-01-01

Objectives To assess the impact of a clinical decision model for febrile children at risk for serious bacterial infections (SBI) attending the emergency department (ED). Methods Randomized controlled trial with 439 febrile children, aged 1 month-16 years, attending the pediatric ED of a Dutch university hospital during 2010-2012. Febrile children were randomly assigned to the intervention (clinical decision model; n=219) or the control group (usual care; n=220). The clinical decision model included clinical symptoms, vital signs, and C-reactive protein and provided high/low-risks for “pneumonia” and “other SBI”. Nurses were guided by the intervention to initiate additional tests for high-risk children. The clinical decision model was evaluated by 1) area-under-the-receiver-operating-characteristic-curve (AUC) to indicate discriminative ability and 2) feasibility, to measure nurses’ compliance to model recommendations. Primary patient outcome was defined as correct SBI diagnoses. Secondary process outcomes were defined as length of stay; diagnostic tests; antibiotic treatment; hospital admission; revisits and medical costs. Results The decision model had good discriminative ability for both pneumonia (n=33; AUC 0.83 (95% CI 0.75-0.90)) and other SBI (n=22; AUC 0.81 (95% CI 0.72-0.90)). Compliance to model recommendations was high (86%). No differences in correct SBI determination were observed. Application of the clinical decision model resulted in less full-blood-counts (14% vs. 22%, p-value<0.05) and more urine-dipstick testing (71% vs. 61%, p-value<0.05). Conclusions In contrast to our expectations no substantial impact on patient outcome was perceived. The clinical decision model preserved, however, good discriminatory ability to detect SBI, achieved good compliance among nurses and resulted in a more standardized diagnostic approach towards febrile children, with less full blood-counts and more rightfully urine-dipstick testing. Trial Registration Nederlands Trial Register NTR2381 PMID:26024532

["Bionic" arm prostheses. State of the art in research and development].

PubMed

Pylatiuk, C; Döderlein, L

2006-11-01

A new generation of arm prostheses is being developed worldwide. These so-called bionic prostheses are intended to offer additional functions, such as sensory feedback, extended range of possible movement, intuitive movement control as far as possible, and a more natural cosmetic appearance. In recent years, prosthetic components with much enhanced performance have been developed for use at various levels of the upper limb. Artificial hands that allow for additional grips are are being tested in clinical settings. Innovative methods of signal acquisition and communication with the patient are being intensively researched. Several patients have been provided with prototypes of new arm prostheses. At the moment, the results are limited by the restricted communication between patient and prosthesis. However, we can expect the options for prosthesis control to be extended in the near future.

Prevalence of depression among people with type 2 diabetes mellitus: a cross sectional study in Palestine.

PubMed

Sweileh, Waleed M; Abu-Hadeed, Hanadi M; Al-Jabi, Samah W; Zyoud, Sa'ed H

2014-02-13

Diabetes mellitus is a common chronic metabolic disorder and one of the main causes of death in Palestine. Palestinians are continuously living under stressful economic and military conditions which make them psychologically vulnerable. The purpose of this study was to investigate the prevalence of depression among type II diabetic patients and to examine the relationship between depression and socio-demographic factors, clinical factors, and glycemic control. This was a cross-sectional study at Al-Makhfiah primary healthcare center, Nablus, Palestine. Two hundred and ninety-four patients were surveyed for the presence of depressive symptoms using Beck Depression Inventory (BDI-II) scale. Patients' records were reviewed to obtain data pertaining to age, sex, marital status, Body Mass Index (BMI), level of education, smoking status, duration of diabetes mellitus, glycemic control using HbA1C test, use of insulin, and presence of additional illnesses. Patients' medication adherence was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8). One hundred and sixty four patients (55.8%) of the total sample were females and 216 (73.5%) were < 65 years old. One hundred and twenty patients (40.2%) scored ≥ 16 on BDI-II scale. Statistical significant association was found between high BDI-II score (≥ 16) and female gender, low educational level, having no current job, having multiple additional illnesses, low medication adherence and obesity (BMI ≥ 30 kg/m2). No significant association between BDI score and glycemic control, duration of diabetes, and other socio-demographic factors was found. Multivatriate analysis showed that low educational level, having no current job, having multiple additional illnesses and low medication adherence were significantly associated with high BDI-II scores. Prevalence of depression found in our study was higher than that reported in other countries. Although 40% of the screened patients were potential cases of depression, none were being treated with anti-depressants. Psychosocial assessment should be part of routine clinical evaluation of these patients at primary healthcare clinics to improve quality of life and decrease adverse outcomes among diabetic patients.

Prevalence of depression among people with type 2 diabetes mellitus: a cross sectional study in Palestine

PubMed Central

2014-01-01

Background Diabetes mellitus is a common chronic metabolic disorder and one of the main causes of death in Palestine. Palestinians are continuously living under stressful economic and military conditions which make them psychologically vulnerable. The purpose of this study was to investigate the prevalence of depression among type II diabetic patients and to examine the relationship between depression and socio-demographic factors, clinical factors, and glycemic control. Methods This was a cross-sectional study at Al-Makhfiah primary healthcare center, Nablus, Palestine. Two hundred and ninety-four patients were surveyed for the presence of depressive symptoms using Beck Depression Inventory (BDI-II) scale. Patients' records were reviewed to obtain data pertaining to age, sex, marital status, Body Mass Index (BMI), level of education, smoking status, duration of diabetes mellitus, glycemic control using HbA1C test, use of insulin, and presence of additional illnesses. Patients’ medication adherence was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8). Results One hundred and sixty four patients (55.8%) of the total sample were females and 216 (73.5%) were < 65 years old. One hundred and twenty patients (40.2%) scored ≥ 16 on BDI-II scale. Statistical significant association was found between high BDI-II score (≥ 16) and female gender, low educational level, having no current job, having multiple additional illnesses, low medication adherence and obesity (BMI ≥ 30 kg/m2). No significant association between BDI score and glycemic control, duration of diabetes, and other socio-demographic factors was found. Multivatriate analysis showed that low educational level, having no current job, having multiple additional illnesses and low medication adherence were significantly associated with high BDI-II scores. Conclusion Prevalence of depression found in our study was higher than that reported in other countries. Although 40% of the screened patients were potential cases of depression, none were being treated with anti-depressants. Psychosocial assessment should be part of routine clinical evaluation of these patients at primary healthcare clinics to improve quality of life and decrease adverse outcomes among diabetic patients. PMID:24524353

Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial.

PubMed

Palmer, Rebecca; Cooper, Cindy; Enderby, Pam; Brady, Marian; Julious, Steven; Bowen, Audrey; Latimer, Nicholas

2015-01-27

Aphasia affects the ability to speak, comprehend spoken language, read and write. One third of stroke survivors experience aphasia. Evidence suggests that aphasia can continue to improve after the first few months with intensive speech and language therapy, which is frequently beyond what resources allow. The development of computer software for language practice provides an opportunity for self-managed therapy. This pragmatic randomised controlled trial will investigate the clinical and cost effectiveness of a computerised approach to long-term aphasia therapy post stroke. A total of 285 adults with aphasia at least four months post stroke will be randomly allocated to either usual care, computerised intervention in addition to usual care or attention and activity control in addition to usual care. Those in the intervention group will receive six months of self-managed word finding practice on their home computer with monthly face-to-face support from a volunteer/assistant. Those in the attention control group will receive puzzle activities, supplemented by monthly telephone calls. Study delivery will be coordinated by 20 speech and language therapy departments across the United Kingdom. Outcome measures will be made at baseline, six, nine and 12 months after randomisation by blinded speech and language therapist assessors. Primary outcomes are the change in number of words (of personal relevance) named correctly at six months and improvement in functional conversation. Primary outcomes will be analysed using a Hochberg testing procedure. Significance will be declared if differences in both word retrieval and functional conversation at six months are significant at the 5% level, or if either comparison is significant at 2.5%. A cost utility analysis will be undertaken from the NHS and personal social service perspective. Differences between costs and quality-adjusted life years in the three groups will be described and the incremental cost effectiveness ratio will be calculated. Treatment fidelity will be monitored. This is the first fully powered trial of the clinical and cost effectiveness of computerised aphasia therapy. Specific challenges in designing the protocol are considered. Registered with Current Controlled Trials ISRCTN68798818 on 18 February 2014.

Revisiting the co-existence of Attention-Deficit/Hyperactivity Disorder and Chronic Tic Disorder in childhood-The case of colour discrimination, sustained attention and interference control.

PubMed

Uebel-von Sandersleben, Henrik; Albrecht, Björn; Rothenberger, Aribert; Fillmer-Heise, Anke; Roessner, Veit; Sergeant, Joseph; Tannock, Rosemary; Banaschewski, Tobias

2017-01-01

Attention Deficit / Hyperactivity Disorder (ADHD) and Chronic Tic Disorder (CTD) are two common and frequently co-existing disorders, probably following an additive model. But this is not yet clear for the basic sensory function of colour processing sensitive to dopaminergic functioning in the retina and higher cognitive functions like attention and interference control. The latter two reflect important aspects for psychoeducation and behavioural treatment approaches. Colour discrimination using the Farnsworth-Munsell 100-hue Test, sustained attention during the Frankfurt Attention Inventory (FAIR), and interference liability during Colour- and Counting-Stroop-Tests were assessed to further clarify the cognitive profile of the co-existence of ADHD and CTD. Altogether 69 children were classified into four groups: ADHD (N = 14), CTD (N = 20), ADHD+CTD (N = 20) and healthy Controls (N = 15) and compared in cognitive functioning in a 2×2-factorial statistical model. Difficulties with colour discrimination were associated with both ADHD and CTD factors following an additive model, but in ADHD these difficulties tended to be more pronounced on the blue-yellow axis. Attention problems were characteristic for ADHD but not CTD. Interference load was significant in both Colour- and Counting-Stroop-Tests and unrelated to colour discrimination. Compared to Controls, interference load in the Colour-Stroop was higher in pure ADHD and in pure CTD, but not in ADHD+CTD, following a sub-additive model. In contrast, interference load in the Counting-Stroop did not reveal ADHD or CTD effects. The co-existence of ADHD and CTD is characterized by additive as well as sub-additive performance impairments, suggesting that their co-existence may show simple additive characteristics of both disorders or a more complex interaction, depending on demand. The equivocal findings on interference control may indicate limited validity of the Stroop-Paradigm for clinical assessments.

Revisiting the co-existence of Attention-Deficit/Hyperactivity Disorder and Chronic Tic Disorder in childhood—The case of colour discrimination, sustained attention and interference control

PubMed Central

Rothenberger, Aribert; Fillmer-Heise, Anke; Roessner, Veit; Sergeant, Joseph; Tannock, Rosemary; Banaschewski, Tobias

2017-01-01

Objective Attention Deficit / Hyperactivity Disorder (ADHD) and Chronic Tic Disorder (CTD) are two common and frequently co-existing disorders, probably following an additive model. But this is not yet clear for the basic sensory function of colour processing sensitive to dopaminergic functioning in the retina and higher cognitive functions like attention and interference control. The latter two reflect important aspects for psychoeducation and behavioural treatment approaches. Methods Colour discrimination using the Farnsworth-Munsell 100-hue Test, sustained attention during the Frankfurt Attention Inventory (FAIR), and interference liability during Colour- and Counting-Stroop-Tests were assessed to further clarify the cognitive profile of the co-existence of ADHD and CTD. Altogether 69 children were classified into four groups: ADHD (N = 14), CTD (N = 20), ADHD+CTD (N = 20) and healthy Controls (N = 15) and compared in cognitive functioning in a 2×2-factorial statistical model. Results Difficulties with colour discrimination were associated with both ADHD and CTD factors following an additive model, but in ADHD these difficulties tended to be more pronounced on the blue-yellow axis. Attention problems were characteristic for ADHD but not CTD. Interference load was significant in both Colour- and Counting-Stroop-Tests and unrelated to colour discrimination. Compared to Controls, interference load in the Colour-Stroop was higher in pure ADHD and in pure CTD, but not in ADHD+CTD, following a sub-additive model. In contrast, interference load in the Counting-Stroop did not reveal ADHD or CTD effects. Conclusion The co-existence of ADHD and CTD is characterized by additive as well as sub-additive performance impairments, suggesting that their co-existence may show simple additive characteristics of both disorders or a more complex interaction, depending on demand. The equivocal findings on interference control may indicate limited validity of the Stroop-Paradigm for clinical assessments. PMID:28594866

Molecular characterization of NRXN1 deletions from 19,263 clinical microarray cases identifies exons important for neurodevelopmental disease expression.

PubMed

Lowther, Chelsea; Speevak, Marsha; Armour, Christine M; Goh, Elaine S; Graham, Gail E; Li, Chumei; Zeesman, Susan; Nowaczyk, Malgorzata J M; Schultz, Lee-Anne; Morra, Antonella; Nicolson, Rob; Bikangaga, Peter; Samdup, Dawa; Zaazou, Mostafa; Boyd, Kerry; Jung, Jack H; Siu, Victoria; Rajguru, Manjulata; Goobie, Sharan; Tarnopolsky, Mark A; Prasad, Chitra; Dick, Paul T; Hussain, Asmaa S; Walinga, Margreet; Reijenga, Renske G; Gazzellone, Matthew; Lionel, Anath C; Marshall, Christian R; Scherer, Stephen W; Stavropoulos, Dimitri J; McCready, Elizabeth; Bassett, Anne S

2017-01-01

The purpose of the current study was to assess the penetrance of NRXN1 deletions. We compared the prevalence and genomic extent of NRXN1 deletions identified among 19,263 clinically referred cases to that of 15,264 controls. The burden of additional clinically relevant copy-number variations (CNVs) was used as a proxy to estimate the relative penetrance of NRXN1 deletions. We identified 41 (0.21%) previously unreported exonic NRXN1 deletions ascertained for developmental delay/intellectual disability that were significantly greater than in controls (odds ratio (OR) = 8.14; 95% confidence interval (CI): 2.91-22.72; P < 0.0001). Ten (22.7%) of these had a second clinically relevant CNV. Subjects with a deletion near the 3' end of NRXN1 were significantly more likely to have a second rare CNV than subjects with a 5' NRXN1 deletion (OR = 7.47; 95% CI: 2.36-23.61; P = 0.0006). The prevalence of intronic NRXN1 deletions was not statistically different between cases and controls (P = 0.618). The majority (63.2%) of intronic NRXN1 deletion cases had a second rare CNV at a prevalence twice as high as that for exonic NRXN1 deletion cases (P = 0.0035). The results support the importance of exons near the 5' end of NRXN1 in the expression of neurodevelopmental disorders. Intronic NRXN1 deletions do not appear to substantially increase the risk for clinical phenotypes.Genet Med 19 1, 53-61.

Hoarding in obsessive-compulsive disorder: clinical and genetic correlates.

PubMed

Lochner, Christine; Kinnear, Craig J; Hemmings, Sian M J; Seller, Cathlene; Niehaus, Dana J H; Knowles, James A; Daniels, Willie; Moolman-Smook, Johanna C; Seedat, Soraya; Stein, Dan J

2005-09-01

Hoarding may be an important symptom dimension in obsessive-compulsive disorder (OCD). Hoarding in OCD has been associated with poor insight, poorer response to selective serotonin reuptake inhibitors than other OCD symptom dimensions, and a distinctive psychobiological profile. The clinical and genetic correlates of hoarding in OCD therefore deserve additional investigation. Adult OCD patients (N = 315) underwent a comprehensive clinical assessment that included the Structured Clinical Interview for DSM-IV Axis I Disorders (Patient Edition) and for Diagnosis of Obsessive-Compulsive Spectrum Disorders. DNA extracted from venous blood (10-30 mL) in a Caucasian subset of the interviewed OCD patients (N = 204) and Caucasian controls (N = 169), including patients (N = 94) and controls (N = 138) of Afrikaner descent, was genotyped to investigate polymorphisms in genes involved in monoamine function and previously hypothesized to be relevant to OCD. Data were collected from 1998 through 2004. OCD patients with hoarding made up 18.1% of the total sample. Compared with nonhoarding OCD, OCD with hoarding was associated with a number of comorbid Axis I disorders, obsessive-compulsive personality disorder, significantly higher OCD severity scores, and more functional impairment. In subjects of Afrikaner descent, the L/L genotype of the COMT Val158Met polymorphism was significantly more common in the OCD hoarding group, with a preponderance of low activity alleles, compared with nonhoarding patients and controls. These data are consistent with the hypothesis that hoarding represents a unique symptom subtype in OCD with a distinctive clinical and psychobiological profile. Further work is needed to determine the psychobiological mechanisms responsible for hoarding and to replicate the genetic findings noted here.

Efficacy of ceftiofur hydrochloride sterile suspension administered parenterally for the treatment of acute postpartum metritis in dairy cows.

PubMed

Chenault, John R; McAllister, Joseph F; Chester, S Theodore; Dame, Kenneth J; Kausche, Fabian M; Robb, Edward J

2004-05-15

To evaluate the efficacy of ceftiofur hydrochloride sterile suspension administered parenterally for treatment of acute postpartum metritis (APM) in dairy cows. Multilocation, randomized block, field trial. 406 cows in the first 14 days postpartum. Cows with rectal temperatures > or = 39.5 degrees C (103.1 degrees F) without clinical signs of respiratory or gastrointestinal tract disease and with a fetid vaginal discharge were allocated randomly in blocks of 3 to 3 treatment groups: sterile saline (0.9% NaCl) solution administered at a dosage of 2 mL/45.4 kg (2 mL/100 lb), SC or IM, once daily for 5 days (control); or ceftiofur hydrochloride administered at a dosage of 1.1 or 2.2 mg of ceftiofur equivalents (CE)/kg (0.5 or 1 mg/lb, respectively), SC or IM, once daily for 5 days. Cows were evaluated on days 6, 10, and 14, and clinical cure or failure to cure was determined. Clinical cure was defined as no additional antimicrobial treatment administered, rectal temperature < 39.5 degrees C, and absence of a fetid vaginal discharge. On day 14, clinical cure rates were 77%, 65%, and 62% for the 2.2 mg of CE/kg, 1.1 mg of CE/kg, and control groups, respectively. No significant differences were detected in clinical cure rates between control and treatment groups on day 10 or 6. Ceftiofur hydrochloride administered at a dosage of 2.2 mg of CE/kg, SC or IM, once daily for 5 days was efficacious for treatment of APM in dairy cows.

Feasibility and efficacy of wearable devices for upper limb rehabilitation in patients with chronic stroke: a randomized controlled pilot study.

PubMed

Lin, Li-Fong; Lin, Yi-Jia; Lin, Zi-Hao; Chuang, Li-Yun; Hsu, Wei-Chun; Lin, Yuan-Hsiang

2017-06-19

Wearable devices based on inertial measurement units through wireless sensor networks have many applications such as real-time motion monitoring and functional outcome assessment of stroke rehabilitation. However, additional investigations are warranted to validate their clinical value, particularly in detecting the synergy patterns of movements after stroke. To explore the feasibility and efficacy of wearable devices for upper limb rehabilitation in patients with chronic stroke and to compare the intervention effects (e.g., neurological recovery, active range of motion, and deviation angle) with those in a control group. A single-blind, randomized-controlled pilot study. Rehabilitation ward. A total of 18 patients with chronic stroke were randomly distributed into a device group and control group. Both groups received conventional rehabilitation; nevertheless, the device group was additionally subjected to 15 daily sessions at least three times a week for 5 weeks. The outcome measures included the upper extremity subscores of the Fugl-Meyer assessment, active range of motion, and deviation angle. These measurements were performed pre- and post-treatment. All five Fugl-Meyer assessment subscores improved in both the device and control groups after intervention; in particular, the "shoulder/elbow/forearm" subscore (p = 0.02, 0.03) and "total score" (p = 0.03, 0.03) substantially improved. The active range of motion of shoulder flexion and abduction substantially improved at pre-post treatment in both the device (p = 0.02, 0.03) and control (p = 0.02, 0.03) groups. The deviation angle of shoulder external rotation during shoulder abduction substantially improved in the device group (p = 0.02), but not in the control group. The designed wearable devices are practical and efficient for use in chronic patients with stroke. Wearable devices are expected to be useful for future internet-of-things rehabilitation clinical trials at home and in long-term care institutions.

TRAPEZE: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of chemotherapy with zoledronic acid, strontium-89, or both, in men with bony metastatic castration-refractory prostate cancer.

PubMed

James, Nicholas; Pirrie, Sarah; Pope, Ann; Barton, Darren; Andronis, Lazaros; Goranitis, Ilias; Collins, Stuart; McLaren, Duncan; O'Sullivan, Joe; Parker, Chris; Porfiri, Emilio; Staffurth, John; Stanley, Andrew; Wylie, James; Beesley, Sharon; Birtle, Alison; Brown, Janet; Chakraborti, Prabir; Russell, Martin; Billingham, Lucinda

2016-07-01

Bony metastatic castration-refractory prostate cancer is associated with a poor prognosis and high morbidity. TRAPEZE was a two-by-two factorial randomised controlled trial of zoledronic acid (ZA) and strontium-89 (Sr-89), each combined with docetaxel. All have palliative benefits, are used to control bone symptoms and are used with docetaxel to prolong survival. ZA, approved on the basis of reducing skeletal-related events (SREs), is commonly combined with docetaxel in practice, although evidence of efficacy and cost-effectiveness is lacking. Sr-89, approved for controlling metastatic pain and reducing need for subsequent bone treatments, is generally palliatively used in patients unfit for chemotherapy. Phase II analysis confirmed the safety and feasibility of combining these agents. TRAPEZE aimed to determine the clinical effectiveness and cost-effectiveness of each agent. Patients were randomised to receive six cycles of docetaxel plus prednisolone: alone, with ZA, with a single Sr-89 dose after cycle 6, or with both. Primary outcomes were clinical progression-free survival (CPFS: time to pain progression, SRE or death) and cost-effectiveness. Secondary outcomes were SRE-free interval (SREFI), total SREs, overall survival (OS) and quality of life (QoL). Log-rank test and Cox regression modelling were used to determine clinical effectiveness. Cost-effectiveness was assessed from the NHS perspective and expressed as cost per additional quality-adjusted life-year (QALY). An additional analysis was carried out for ZA to reflect the availability of generic ZA. 757 randomised (median age 68.7 years; Eastern Cooperative Oncology Group scale score 0, 40%; 1, 52%; 2, 8%; prior radiotherapy, 45%); median prostate-specific antigen 143.78 ng/ml (interquartile range 50.8-353.9 ng/ml). Stratified log-rank analysis of CPFS was statistically non-significant for either agent (Sr-89, p = 0.11; ZA, p = 0.45). Cox regression analysis adjusted for stratification variables showed CPFS benefit for Sr-89 [hazard ratio (HR) 0.845, 95% confidence interval (CI) 0.72 to 0.99; p = 0.036] and confirmed no effect of ZA (p = 0.46). ZA showed a significant SREFI effect (HR 0.76; 95% CI 0.63 to 0.93; p = 0.008). Neither agent affected OS (Sr-89, p = 0.74; ZA, p = 0.91), but both increased total cost (vs. no ZA and no Sr-89, respectively); decreased post-trial therapies partly offset costs [net difference: Sr-89 £1341; proprietary ZA (Zometa(®), East Hanover, NJ, USA) £1319; generic ZA £251]. QoL was maintained in all trial arms; Sr-89 (0.08 additional QALYs) and ZA (0.03 additional QALYs) showed slight improvements. The resulting incremental cost-effectiveness ratio (ICER) for Sr-89 was £16,590, with £42,047 per QALY for Zometa and £8005 per QALY for generic ZA. Strontium-89 improved CPFS, but not OS. ZA did not improve CPFS or OS but significantly improved SREFI, mostly post progression, suggesting a role as post-chemotherapy maintenance therapy. QoL was well maintained in all treatment arms, with differing patterns of care resulting from the effects of Sr-89 on time to progression and ZA on SREFI and total SREs. The addition of Sr-89 resulted in additional cost and a small positive increase in QALYs, with an ICER below the £20,000 ceiling per QALY. The additional costs and small positive QALY changes in favour of ZA resulted in ICERs of £42,047 (Zometa) and £8005 for the generic alternative; thus, generic ZA represents a cost-effective option. Additional analyses on the basis of data from the Hospital Episode Statistics data set would allow corroborating the findings of this study. Further research into the use of ZA (and other bone-targeting therapies) with newer prostate cancer therapies would be desirable. Current Controlled Trials ISRCTN12808747. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 53. See the NIHR Journals Library website for further project information.

Saxagliptin co-therapy in C-peptide negative Type 1 diabetes does not improve counter-regulatory responses to hypoglycaemia.

PubMed

George, P S; McCrimmon, R J

2016-09-01

To test the hypothesis that dipeptidyl peptidase-4 inhibition in C-peptide negative Type 1 diabetes would reduce glucose variability and exposure to hypoglycaemia and therefore may indirectly enhance counter-regulatory responses to subsequent hypoglycaemia. We conducted a 12-week double-blind, randomized, placebo-controlled crossover study. The study was conducted in a tertiary hospital outpatient clinic, with additional studies performed in a clinical research centre. After obtaining informed consent, we recruited 14 subjects with moderately well controlled Type 1 diabetes (HbA1c 64 ± 2 mmol/mol) of long duration (20.5 ± 2.7 years). The subjects received 12 weeks' therapy with oral saxagliptin (5 mg) or placebo. Glucose variability, assessed via continuous glucose monitoring, together with frequency of hypoglycaemia, hypoglycaemia awareness and symptomatic, cognitive and counter-regulatory hormone responses to experimental hypoglycaemia, were assessed. Additional outcome measures included HbA1c level, weight, total daily insulin dose and adverse events. Saxagliptin co-therapy did not reduce glucose variability (low blood glucose index, average daily risk range), hypoglycaemia frequency or awareness and did not improve counter-regulatory hormonal responses during experimental hypoglycaemia (area under the curve for adrenaline 25 775 vs. 24 454, for placebo vs saxagliptin, respectively; P = 0.76). No additional benefit of dipeptidyl peptidase-4 inhibition co-therapy with saxagliptin in the management of Type 1 diabetes was observed. © 2015 Diabetes UK.

Association of Betel Nut with Carcinogenesis: Revisit with a Clinical Perspective

PubMed Central

Sharan, Rajeshwar N.; Mehrotra, Ravi; Choudhury, Yashmin; Asotra, Kamlesh

2012-01-01

Abstract Betel nut (BN), betel quid (BQ) and products derived from them are widely used as a socially endorsed masticatory product. The addictive nature of BN/BQ has resulted in its widespread usage making it the fourth most abused substance by humans. Progressively, several additives, including chewing tobacco, got added to simple BN preparations. This addictive practice has been shown to have strong etiological correlation with human susceptibility to cancer, particularly oral and oropharyngeal cancers. The PUBMED database was searched to retrieve all relevant published studies in English on BN and BQ, and its association with oral and oropharyngeal cancers. Only complete studies directly dealing with BN/BQ induced carcinogenesis using statistically valid and acceptable sample size were analyzed. Additional relevant information available from other sources was also considered. This systematic review attempts to put in perspective the consequences of this widespread habit of BN/BQ mastication, practiced by approximately 10% of the world population, on oral cancer with a clinical perspective. BN/BQ mastication seems to be significantly associated with susceptibility to oral and oropharyngeal cancers. Addition of tobacco to BN has been found to only marginally increase the cancer risk. Despite the widespread usage of BN/BQ and its strong association with human susceptibility to cancer, no serious strategy seems to exist to control this habit. The review, therefore, also looks at various preventive efforts being made by governments and highlights the multifaceted intervention strategies required to mitigate and/or control the habit of BN/BQ mastication. PMID:22912735

Examining the proportion of dietary phosphorus from plants, animals and food additives excreted in urine

PubMed Central

St-Jules, David E; Jagannathan, Ram; Gutekunst, Lisa; Kalantar-Zadeh, Kamyar; Sevick, Mary Ann

2016-01-01

Phosphorus bioavailability is an emerging topic of interest in the field of renal nutrition that has important research and clinical implications. Estimates of phosphorus bioavailability, based on digestibility, indicate that bioavailability of phosphorus increases from plants to animals to food additives. In this commentary, we examined the proportion of dietary phosphorus from plants, animals and food additives excreted in urine from four controlled feeding studies conducted in healthy adults and patients with chronic kidney disease. As expected, a smaller proportion of phosphorus from plant foods was excreted in urine compared to animal foods. However, contrary to expectations, phosphorus from food additives appeared to be incompletely absorbed. The apparent discrepancy between digestibility of phosphorus additives and the proportion excreted in urine suggests a need for human balance studies to determine the bioavailability of different sources of phosphorus. PMID:27810171

Examining the Proportion of Dietary Phosphorus From Plants, Animals, and Food Additives Excreted in Urine.

PubMed

St-Jules, David E; Jagannathan, Ram; Gutekunst, Lisa; Kalantar-Zadeh, Kamyar; Sevick, Mary Ann

2017-03-01

Phosphorus bioavailability is an emerging topic of interest in the field of renal nutrition that has important research and clinical implications. Estimates of phosphorus bioavailability, based on digestibility, indicate that bioavailability of phosphorus increases from plants to animals to food additives. In this commentary, we examined the proportion of dietary phosphorus from plants, animals, and food additives excreted in urine from four controlled-feeding studies conducted in healthy adults and patients with chronic kidney disease. As expected, a smaller proportion of phosphorus from plant foods was excreted in urine compared to animal foods. However, contrary to expectations, phosphorus from food additives appeared to be incompletely absorbed. The apparent discrepancy between digestibility of phosphorus additives and the proportion excreted in urine suggests a need for human balance studies to determine the bioavailability of different sources of phosphorus. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Listening with a narrative ear: Insights from a study of fall stories in older adults.

PubMed

Pereles, Laurie; Jackson, Roberta; Rosenal, Tom; Nixon, Lara

2017-01-01

To determine the value of adding a patient narrative to the clinical assessment of falls in the elderly. Qualitative study of interviews. A fall prevention clinic in Calgary, Alta. Fifteen older adults on a wait list for assessment by the fall clinic and the physiotherapists who assessed them. Participants' stories were audiorecorded and later transcribed and summarized. Stories were collected using open-ended questions, first inviting participants to tell the interviewer about themselves, and then the circumstances of their falls and their reflections on them. In a subsequent visit, transcriptions or summaries were returned to patients for member checking. Narratives were read and analyzed by all 4 investigators using a narrative approach and a close-reading technique. With the patients' additional consent, stories were shared with the fall prevention team for their insights and reactions. Interviews with physiotherapists were audiorecorded and transcribed. The narrative analysis provided new insights into the attitudes about and perceptions of the causes of falls, their effects, and rehabilitation. Close reading exposed presentation of self, locus of control, and underlying social and emotional issues. The addition of patient narratives to clinical assessments offers clinicians an understanding of patients' perspectives, which can be used to better engage patients in rehabilitation. Copyright© the College of Family Physicians of Canada.

Listening with a narrative ear

PubMed Central

Pereles, Laurie; Jackson, Roberta; Rosenal, Tom; Nixon, Lara

2017-01-01

Abstract Objective To determine the value of adding a patient narrative to the clinical assessment of falls in the elderly. Design Qualitative study of interviews. Setting A fall prevention clinic in Calgary, Alta. Participants Fifteen older adults on a wait list for assessment by the fall clinic and the physiotherapists who assessed them. Methods Participants’ stories were audiorecorded and later transcribed and summarized. Stories were collected using open-ended questions, first inviting participants to tell the interviewer about themselves, and then the circumstances of their falls and their reflections on them. In a subsequent visit, transcriptions or summaries were returned to patients for member checking. Narratives were read and analyzed by all 4 investigators using a narrative approach and a close-reading technique. With the patients’ additional consent, stories were shared with the fall prevention team for their insights and reactions. Interviews with physiotherapists were audiorecorded and transcribed. Main findings The narrative analysis provided new insights into the attitudes about and perceptions of the causes of falls, their effects, and rehabilitation. Close reading exposed presentation of self, locus of control, and underlying social and emotional issues. Conclusion The addition of patient narratives to clinical assessments offers clinicians an understanding of patients’ perspectives, which can be used to better engage patients in rehabilitation. PMID:28115459

[A historical view of the specialty of clinical microbiology].

PubMed

Pérez, Evelio Perea; Álvarez, Rogelio Martín

2010-10-01

Clinical microbiology today is a well established specialty in Spain whose development has necessarily been linked to improvements in the diagnosis, treatment and prevention of infectious diseases. Over time, clinical, teaching, and research structures have been organized around these diseases. In addition, a scientific society for specialists in infectious diseases (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica) has been set up, which in turn, publishes the journal ENFERMEDADES INFECCIOSAS Y MICROBIOLOGÍA CLÍNICA, and organizes congresses, meetings, working groups and a quality control program, etc. Clinical microbiologists will continue to be needed to meet future challenges (identification of new pathogenic microorganisms, methodological changes, diagnostic quality and speed, nosocomial infections, the development of antimicrobial resistance, etc.), which constitute a well-defined area of knowledge specific to our specialty. Copyright © 2010 Elsevier España S.L. All rights reserved.

Predictors of Clinical Outcomes in Sexually Abused Adolescents.

PubMed

Tocker, Lotem; Ben-Amitay, Galit; Horesh-Reinman, Netta; Lask, Michal; Toren, Paz

2017-01-01

This cross-sectional, case control study examines the association between child sexual abuse and interpersonal and intrapersonal outcomes among 54 adolescents, examining specific clinical measures (depression, anxiety, dissociation, and posttraumatic stress disorder, attachment patterns, self-esteem, self-disclosure, and family environment characteristics). The research results point to a correlation between sexual abuse and higher levels of the clinical measures. In addition, a correlation was found between sexual abuse and level of avoidant attachment, self-esteem, and family environment characteristics. Stepwise hierarchical regressions were conducted to examine how adolescent attributes predicted depression, anxiety, and dissociation beyond the prediction based on sexual abuse. A combination of self-esteem, anxiety attachment, and family cohesiveness made sexual abuse insignificant when predicting levels of depression, anxiety, and dissociation. This study contributes to characterizing the emotional, personal, and family attributes of adolescents who experienced sexual abuse. It also raises questions about the clinical outcomes usually associated with sexual abuse.

Designing a Clinical Data Warehouse Architecture to Support Quality Improvement Initiatives.

PubMed

Chelico, John D; Wilcox, Adam B; Vawdrey, David K; Kuperman, Gilad J

2016-01-01

Clinical data warehouses, initially directed towards clinical research or financial analyses, are evolving to support quality improvement efforts, and must now address the quality improvement life cycle. In addition, data that are needed for quality improvement often do not reside in a single database, requiring easier methods to query data across multiple disparate sources. We created a virtual data warehouse at NewYork Presbyterian Hospital that allowed us to bring together data from several source systems throughout the organization. We also created a framework to match the maturity of a data request in the quality improvement life cycle to proper tools needed for each request. As projects progress in the Define, Measure, Analyze, Improve, Control stages of quality improvement, there is a proper matching of resources the data needs at each step. We describe the analysis and design creating a robust model for applying clinical data warehousing to quality improvement.

Designing a Clinical Data Warehouse Architecture to Support Quality Improvement Initiatives

PubMed Central

Chelico, John D.; Wilcox, Adam B.; Vawdrey, David K.; Kuperman, Gilad J.

2016-01-01

Clinical data warehouses, initially directed towards clinical research or financial analyses, are evolving to support quality improvement efforts, and must now address the quality improvement life cycle. In addition, data that are needed for quality improvement often do not reside in a single database, requiring easier methods to query data across multiple disparate sources. We created a virtual data warehouse at NewYork Presbyterian Hospital that allowed us to bring together data from several source systems throughout the organization. We also created a framework to match the maturity of a data request in the quality improvement life cycle to proper tools needed for each request. As projects progress in the Define, Measure, Analyze, Improve, Control stages of quality improvement, there is a proper matching of resources the data needs at each step. We describe the analysis and design creating a robust model for applying clinical data warehousing to quality improvement. PMID:28269833

Opiate Antagonists Do Not Interfere With the Clinical Benefits of Stimulants in ADHD: A Double-Blind, Placebo-Controlled Trial of the Mixed Opioid Receptor Antagonist Naltrexone.

PubMed

Spencer, Thomas J; Bhide, Pradeep; Zhu, Jinmin; Faraone, Stephen V; Fitzgerald, Maura; Yule, Amy M; Uchida, Mai; Spencer, Andrea E; Hall, Anna M; Koster, Ariana J; Biederman, Joseph

Methylphenidate activates μ-opioid receptors, which are linked to euphoria. μ-Opioid antagonists, such as naltrexone, may attenuate the euphoric effects of stimulants, thereby minimizing their abuse potential. This study assessed whether the combination of naltrexone with methylphenidate is well-tolerated while preserving the clinical benefits of stimulants in subjects with attention-deficit/hyperactivity disorder (ADHD). We conducted a 6-week, double-blind, placebo-controlled, randomized clinical trial of naltrexone in adults with DSM-IV ADHD receiving open treatment with a long-acting formulation of methylphenidate from January 2013 to July 2015. Spheroidal Oral Drug Absorption System (SODAS) methylphenidate was administered twice daily, was titrated to approximately 1 mg/kg/d over 3 weeks, and was continued for 3 additional weeks depending on response and adverse effects. Subjects were adults with ADHD preselected for having experienced euphoria with a test dose of immediate-release methylphenidate. The primary outcome measure was the Adult ADHD Investigator Symptom Report Scale (AISRS). Thirty-seven subjects who experienced stimulant-induced (mild) euphoria at a baseline visit were started in the open trial of SODAS methylphenidate and randomly assigned to naltrexone 50 mg or placebo. Thirty-one subjects completed the study through week 3, and 25 completed through week 6. Throughout 6 weeks of blinded naltrexone and open methylphenidate treatment, the coadministration of naltrexone with methylphenidate did not interfere with the clinical effectiveness of methylphenidate for ADHD symptoms. Additionally, the combination of naltrexone and methylphenidate did not produce an increase in adverse events compared with methylphenidate alone. Our findings provide support for the concept of combining opioid receptor antagonists with stimulants to provide an effective stimulant formulation with less abuse potential. ClinicalTrials.gov identifier: NCT01673594​. © Copyright 2017 Physicians Postgraduate Press, Inc.

Controlled cytotoxicity of plasma treated water formulated by open-air hybrid mode discharge

NASA Astrophysics Data System (ADS)

Lu, P.; Boehm, D.; Cullen, P.; Bourke, P.

2017-06-01

Plasma treated liquids (PTLs) provide a means to convey a broad range of effects of relevance for food, environmental, or clinical decontamination, plant growth promotion, and therapeutic applications. Devising the reactive species ingredients and controlling the biological response of PTLs are of great interest. We demonstrate an approach by using an open-air hybrid mode discharge (HMD) to control the principal reactive species composition within plasma treated water (PTW), which is then demonstrated to regulate the cytotoxicity of PTW. The cytotoxicity of HMD produced PTW demonstrates a non-monotonic change over the discharge time. Although hydrogen peroxide and nitrite are not the sole effectors for cell death caused by PTW, using them as principal reactive species indicators, cytotoxicity can be removed and/or enhanced by formulating their concentrations and composition through adjusting the discharge mode and time on-line during PTW generation without the addition of additional working gas or chemical scavengers. This work demonstrates that a hybrid mode discharge can be employed to generate a PTW formulation to control a biological response such as cytotoxicity. This provides insights into how plasma treated liquids may be harnessed for biological applications in a specific and controllable manner.

[Observation of Attachment Disorder Symptoms in Middle Childhood].

PubMed

Iwanski, Alexandra; Zimmermann, Peter

2018-05-01

Observation of Attachment Disorder Symptoms in Middle Childhood Attachment in childhood is mainly assessed by observation. In contrast, assessment of attachment disorder symptoms (RAD) is mainly based on caregiver reports. The present study uses a newly developed observation tool (Coding of Attachment Disorder Behavior in Children; Iwanski u. Zimmermann, 2013) to assess attachment disorder symptoms in a group of school-aged children from a risk group for the development of attachment disorder symptoms and non-clinical controls. In addition, caregiver reports on RAD symptoms are also assessed (Relationship Problems Questionnaire; Minnis, Rabe-Hesketh, Wolkind, 2002; Disturbances of Attachment Interview; Smyke u. Zeanah, 1999). Moreover, associations with children's self-concept (Harter, 2012) were studied. Results reveal that children at risk showed more inhibited and disinhibited attachment disorder symptoms and a more negative self-concept compared to non-clinical controls. RAD symptoms are shown in interaction with both the caregiver and a stranger. The use of a reliable and valid observation tool for the diagnostic of attachment disorder symptoms besides ratings of caregivers is recommended for clinical practice and research.

A Comparison of Two Internet Programs for Adolescents with Type 1 Diabetes: Design and Methods

PubMed Central

Grey, Margaret; Whittemore, Robin; Liberti, Lauren; Delamater, Alan; Murphy, Kathryn; Faulkner, Melissa S.

2012-01-01

Implementing psycho-educational programs for youth with type 1 diabetes in clinical care and reaching diverse youth with type 1 diabetes is challenging due to youth, provider, and organizational barriers. This study was designed to compare the effectiveness of an internet coping skills training program with a control condition of internet diabetes education. Each program consists of 5 weekly interactive lessons; the coping skills training program also provides the ability for youth to interact with each other as well as a health coach. Approximately 300 youth with type 1 diabetes will be recruited to participate in this multi-site clinical trial. The primary outcomes are metabolic control, quality of life, and family conflict. Secondary outcomes include stress, coping, self-efficacy, and social competence. Usage, satisfaction, and cost will also be evaluated. In addition, mediators and moderators to intervention effects will be explored. An internet based psycho-educational program for youth with type 1 diabetes may be a promising approach that can be easily be integrated into clinical care. PMID:22484337

Is hydrokinesitherapy effective on gait and balance in patients with stroke? A clinical and baropodometric investigation.

PubMed

Furnari, Anna; Calabrò, Rocco Salvatore; Gervasi, Giuseppe; La Fauci-Belponer, Francesca; Marzo, Antonio; Berbiglia, Fabio; Paladina, Giuseppe; De Cola, Maria Cristina; Bramanti, Placido

2014-01-01

Patients with stroke present an asymmetric posture, severe balance dysfunction with delayed and disrupted equilibrium reactions, exaggerated postural sway and abnormal gait with an increased risk of falling. The aim of this study is to evaluate the efficacy of hydrokinesytherapy on stance, balance and gait in individuals after stroke. In this single-blinded randomized controlled trial, patients with stroke were divided into two groups: an experimental one (G1), performing hydrokinesytherapy (3 times/week) in addition to a conventional physical therapy (3 times/week) and a control one (G2), performing only a conventional physical therapy (6 times/week). All of the participants underwent a proper clinical and baropodometric evaluation before and after 8 weeks of treatment. The two groups presented similar clinical and instrumental features at enrolment (mean modified Rankin Scale of 3, and a disease duration of 6.3 ± 1.4 months). After treatment, the patients undergoing hydrokinesytherapy showed a significantly greater improvement than those undergoing traditional training. Hydrokinesytherapy may be considered a promising treatment in improving gait and balance in individuals following stroke.

Associations between the decrease in bovine clinical mastitis and changes in dairy farmers' attitude, knowledge, and behavior in the Netherlands.

PubMed

van den Borne, B H P; Jansen, J; Lam, T J G M; van Schaik, G

2014-10-01

The aim of this study was to associate changes in dairy farmers' self-reported attitude, knowledge, and behavior with the decrease in incidence rate of clinical mastitis (IRCM). Farmer-diagnosed clinical mastitis cases were obtained from two surveys conducted before (July 2004-June 2005) and at the end (2009) of a mastitis control program in the Netherlands. Information on farmers' attitude, knowledge, and behavior was also obtained by sending the farmers the same questionnaire during both surveys. Multivariable linear regression models identified that the herd level 2004 IRCM explained 28% of the variation in the decrease of IRCM. Changes in farmers' attitude and knowledge, and changes in farmers' behavior additionally explained 24% and 5%, respectively. These results suggest that the way management measures are executed may be at least as important as the fact that they are executed. No control group was available for this study because the intervention was applied at the national level. We therefore do not claim any causal relationships. Copyright © 2014 Elsevier Ltd. All rights reserved.

Mastery moderates the negative effect of stigma on depressive symptoms in people living with HIV.

PubMed

Rueda, Sergio; Gibson, Katherine; Rourke, Sean B; Bekele, Tsegaye; Gardner, Sandra; Cairney, John

2012-04-01

Stigma continues to have a negative effect on the care, treatment, and support of people living with HIV. This study presents baseline data from 825 participants taking part in a cohort study that collects data on the clinical profile and social determinants of health of people with HIV. We performed multivariate regression analysis to evaluate whether mastery and social support moderated the negative effect of stigma on depressive symptoms. Stigma was associated with depressive symptoms after controlling for potential demographic and clinical confounders. In addition, higher levels of mastery and social support were associated with lower levels of depression. However, only mastery moderated the negative effects of stigma on depressive symptoms. For individuals with high levels of mastery, greater exposure to stigma does not translate into greater distress. Interventions targeting the mental health concerns of people with HIV should increase their focus on improving people' sense of personal control.

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.

Recent Translational Findings on Impulsivity in Relation to Drug Abuse

PubMed Central

Weafer, Jessica; Mitchell, Suzanne H.

2015-01-01

Impulsive behavior is strongly implicated in drug abuse, as both a cause and a consequence of drug use. To understand how impulsive behaviors lead to and result from drug use, translational evidence from both human and non-human animal studies is needed. Here, we review recent (2009 or later) studies that have investigated two major components of impulsive behavior, inhibitory control and impulsive choice, across preclinical and clinical studies. We concentrate on the stop-signal task as the measure of inhibitory control and delay discounting as the measure of impulsive choice. Consistent with previous reports, recent studies show greater impulsive behavior in drug users compared with non-users. Additionally, new evidence supports the prospective role of impulsive behavior in drug abuse, and has begun to identify the neurobiological mechanisms underlying impulsive behavior. We focus on the commonalities and differences in findings between preclinical and clinical studies, and suggest future directions for translational research. PMID:25678985

The Dengue Vaccine Pipeline: Implications for the Future of Dengue Control

PubMed Central

Schwartz, Lauren M.; Halloran, M. Elizabeth; Durbin, Anna P.; Longini, Ira M.

2015-01-01

Dengue has become the most rapidly expanding mosquito-borne infectious disease on the planet, surpassing malaria and infecting at least 390 million people per year. There is no effective treatment for dengue illness other than supportive care, especially for severe cases. Symptoms can be mild or life-threatening as in dengue hemorrhagic fever and dengue shock syndrome. Vector control has been only partially successful in decreasing dengue transmission. The potential use of safe and effective tetravalent dengue vaccines is an attractive addition to prevent disease or minimize the possibility of epidemics. There are currently no licensed dengue vaccines. This review summarizes the current status of all dengue vaccine candidates in clinical evaluation. Currently five candidate vaccines are in human clinical trials. One has completed two Phase III trials, two are in Phase II trials, and three are in Phase I testing. PMID:25989449

Neurobiochemical mechanisms of a ketogenic diet in refractory epilepsy.

PubMed

Lima, Patricia Azevedo de; Sampaio, Leticia Pereira de Brito; Damasceno, Nágila Raquel Teixeira

2014-12-01

A ketogenic diet is an important therapy used in the control of drug-refractory seizures. Many studies have shown that children and adolescents following ketogenic diets exhibit an over 50% reduction in seizure frequency, which is considered to be clinically relevant. These benefits are based on a diet containing high fat (approximately 90% fat) for 24 months. This dietary model was proposed in the 1920s and has produced variable clinical responses. Previous studies have shown that the mechanisms underlying seizure control involve ketone bodies, which are produced by fatty acid oxidation. Although the pathways involved in the ketogenic diet are not entirely clear, the main effects of the production of ketone bodies appear to be neurotransmitter modulation and antioxidant effects on the brain. This review highlights the impacts of the ketogenic diet on the modulation of neurotransmitters, levels of biogenic monoamines and protective antioxidant mechanisms of neurons. In addition, future perspectives are proposed.

Centers for Disease Control and Prevention Expert Panel Meetings on Prevention and Treatment of Anthrax in Adults

PubMed Central

Hendricks, Katherine A.; Wright, Mary E.; Shadomy, Sean V.; Bradley, John S.; Morrow, Meredith G.; Pavia, Andy T.; Rubinstein, Ethan; Holty, Jon-Erik C.; Messonnier, Nancy E.; Smith, Theresa L.; Pesik, Nicki; Treadwell, Tracee A.

2014-01-01

The Centers for Disease Control and Prevention convened panels of anthrax experts to review and update guidelines for anthrax postexposure prophylaxis and treatment. The panels included civilian and military anthrax experts and clinicians with experience treating anthrax patients. Specialties represented included internal medicine, pediatrics, obstetrics, infectious disease, emergency medicine, critical care, pulmonology, hematology, and nephrology. Panelists discussed recent patients with systemic anthrax; reviews of published, unpublished, and proprietary data regarding antimicrobial drugs and anthrax antitoxins; and critical care measures of potential benefit to patients with anthrax. This article updates antimicrobial postexposure prophylaxis and antimicrobial and antitoxin treatment options and describes potentially beneficial critical care measures for persons with anthrax, including clinical procedures for infected nonpregnant adults. Changes from previous guidelines include an expanded discussion of critical care and clinical procedures and additional antimicrobial choices, including preferred antimicrobial drug treatment for possible anthrax meningitis. PMID:24447897

Centers for disease control and prevention expert panel meetings on prevention and treatment of anthrax in adults.

PubMed

Hendricks, Katherine A; Wright, Mary E; Shadomy, Sean V; Bradley, John S; Morrow, Meredith G; Pavia, Andy T; Rubinstein, Ethan; Holty, Jon-Erik C; Messonnier, Nancy E; Smith, Theresa L; Pesik, Nicki; Treadwell, Tracee A; Bower, William A

2014-02-01

The Centers for Disease Control and Prevention convened panels of anthrax experts to review and update guidelines for anthrax postexposure prophylaxis and treatment. The panels included civilian and military anthrax experts and clinicians with experience treating anthrax patients. Specialties represented included internal medicine, pediatrics, obstetrics, infectious disease, emergency medicine, critical care, pulmonology, hematology, and nephrology. Panelists discussed recent patients with systemic anthrax; reviews of published, unpublished, and proprietary data regarding antimicrobial drugs and anthrax antitoxins; and critical care measures of potential benefit to patients with anthrax. This article updates antimicrobial postexposure prophylaxis and antimicrobial and antitoxin treatment options and describes potentially beneficial critical care measures for persons with anthrax, including clinical procedures for infected nonpregnant adults. Changes from previous guidelines include an expanded discussion of critical care and clinical procedures and additional antimicrobial choices, including preferred antimicrobial drug treatment for possible anthrax meningitis.

Development of a cerebral circulation model for the automatic control of brain physiology.

PubMed

Utsuki, T

2015-01-01

In various clinical guidelines of brain injury, intracranial pressure (ICP), cerebral blood flow (CBF) and brain temperature (BT) are essential targets for precise management for brain resuscitation. In addition, the integrated automatic control of BT, ICP, and CBF is required for improving therapeutic effects and reducing medical costs and staff burden. Thus, a new model of cerebral circulation was developed in this study for integrative automatic control. With this model, the CBF and cerebral perfusion pressure of a normal adult male were regionally calculated according to cerebrovascular structure, blood viscosity, blood distribution, CBF autoregulation, and ICP. The analysis results were consistent with physiological knowledge already obtained with conventional studies. Therefore, the developed model is potentially available for the integrative control of the physiological state of the brain as a reference model of an automatic control system, or as a controlled object in various control simulations.

Novel RSPO1 mutation causing 46,XX testicular disorder of sex development with palmoplantar keratoderma: A review of literature and expansion of clinical phenotype.

PubMed

Tallapaka, Karthik; Venugopal, Vineeth; Dalal, Ashwin; Aggarwal, Shagun

2018-04-01

Palmoplantar hyperkeratosis with squamous cell carcinoma of skin and sex reversal (MIM # 610644) is a clinically distinctive form of SRY-negative 46,XX disorder of sex development. It is a rare autosomal recessive disorder caused due to biallelic loss of function mutations in RSPO1 gene. RSPO1 acts by activating the canonical β-catenin pathway and is one of the most important genes controlling female gonadal differentiation. RSPO1-associated disorders of sex development have been described only in three instances in the past. We report fourth such case with additional findings and perform a comparative review of previous phenotypic descriptions, thereby expanding the clinical phenotype of this syndrome. © 2018 Wiley Periodicals, Inc.

Norovirus

PubMed Central

Robilotti, Elizabeth; Deresinski, Stan

2015-01-01

SUMMARY Norovirus, an RNA virus of the family Caliciviridae, is a human enteric pathogen that causes substantial morbidity across both health care and community settings. Several factors enhance the transmissibility of norovirus, including the small inoculum required to produce infection (<100 viral particles), prolonged viral shedding, and its ability to survive in the environment. In this review, we describe the basic virology and immunology of noroviruses, the clinical disease resulting from infection and its diagnosis and management, as well as host and pathogen factors that complicate vaccine development. Additionally, we discuss overall epidemiology, infection control strategies, and global reporting efforts aimed at controlling this worldwide cause of acute gastroenteritis. Prompt implementation of infection control measures remains the mainstay of norovirus outbreak management. PMID:25567225

Does the addition of visceral manipulation alter outcomes for patients with low back pain? A randomized placebo controlled trial.

PubMed

Panagopoulos, J; Hancock, M J; Ferreira, P; Hush, J; Petocz, P

2015-08-01

This study aimed to investigate whether the addition of visceral manipulation, to a standard physiotherapy algorithm, improved outcomes in patients with low back pain. Sixty-four patients with low back pain who presented for treatment at a private physiotherapy clinic were randomized to one of two groups: standard physiotherapy plus visceral manipulation (n = 32) or standard physiotherapy plus placebo visceral manipulation (n = 32). The primary outcome was pain (measured with the 0-10 Numerical Pain Rating Scale) at 6 weeks. Secondary outcomes were pain at 2 and 52 weeks, disability (measured with the Roland-Morris Disability Questionnaire) at 2, 6 and 52 weeks and function (measured with the Patient-Specific Functional Scale) at 2, 6 and 52 weeks. This trial was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12611000757910). The addition of visceral manipulation did not affect the primary outcome of pain at 6 weeks (-0.12, 95% CI = -1.45 to 1.21). There were no significant between-group differences for the secondary outcomes of pain at 2 weeks or disability and function at 2, 6 or 52 weeks. The group receiving addition of visceral manipulation had less pain than the placebo group at 52 weeks (mean 1.57, 95% CI = 0.32 to 2.82). Participants were adequately blinded to group status and there were no adverse effects reported in either group. Our study suggests that visceral manipulation in addition to standard care is not effective in changing short-term outcomes but may produce clinically worthwhile improvements in pain at 1 year. © 2014 European Pain Federation - EFIC®

Assessing the Impact of Peer Educator Outreach on the Likelihood and Acceleration of Clinic Utilization among Sex Workers.

PubMed

Krishnamurthy, Parthasarathy; Hui, Sam K; Shivkumar, Narayanan; Gowda, Chandrasekhar; Pushpalatha, R

2016-01-01

Peer-led outreach is a critical element of HIV and STI-reduction interventions aimed at sex workers. We study the association between peer-led outreach to sex workers and the time to utilize health facilities for timely STI syndromic-detection and treatment. Using data on the timing of peer-outreach interventions and clinic visits, we utilize an Extended Cox model to assess whether peer educator outreach intensity is associated with accelerated clinic utilization among sex workers. Our data comes from 2705 female sex workers registered into Pragati, a women-in-sex-work outreach program, and followed from 2008 through 2012. We analyze this data using an Extended Cox model with the density of peer educator visits in a 30-day rolling window as the key predictor, while controlling for the sex workers' age, client volume, location of sex work, and education level. The principal outcome of interest is the timing of the first voluntary clinic utilization. More frequent peer visit is associated with earlier first clinic visit (HR: 1.83, 95% CI, 1.75-1.91, p < .001). In addition, 18% of all syndrome-based STI detected come from clinic visits in which the sex worker reports no symptoms, underscoring the importance of inducing clinic visits in the detection of STI. Additional models to test the robustness of these findings indicate consistent beneficial effect of peer educator outreach. Peer outreach density is associated with increased likelihood of-and shortened duration to-clinic utilization among female sex workers, suggesting potential staff resourcing implications. Given the observational nature of our study, however, these findings should be interpreted as an association rather than as a causal relationship.

Evaluation of moxifloxacin-hydroxyapatite composite graft in the regeneration of intrabony defects: A clinical, radiographic, and microbiological study

PubMed Central

Nagarjuna Reddy, Y. V.; Deepika, P. C.; Venkatesh, M. P.; Rajeshwari, K. G.

2016-01-01

Background: The formation of new connective periodontal attachment is contingent upon the elimination or marked reduction of pathogens at the treated periodontal site. An anti-microbial agent, i.e. moxifloxacin has been incorporated into the bone graft to control infection and facilitate healing during and after periodontal therapy. Materials and Methods: By purposive sampling, 15 patients with at least two contralateral vertical defect sites were selected. The selected sites in each individual were divided randomly into test and control sites according to split-mouth design. Test site received moxifloxacin-hydroxyapatite composite graft and control site received hydroxyapatite-placebo gel composite graft. Probing depth (PD) and Clinical attachment level (CAL) were assessed at baseline, 3, 6, 9, and 12 months. Bone probing depth (BPD) and hard tissue parameters such as amount of defect fill, percentage of defect fill, and changes in alveolar crest were assessed at baseline, 6, and 12 months. Changes in subgingival microflora were also assessed by culturing the subgingival plaque samples at baseline and at 3-month follow-up. The clinical, radiographic, and microbiological data obtained were subjected to statistical analysis using descriptive statistics, paired sample t-test, independent t-test, and contingency test. Results: On intragroup comparison at test and control sites, there was a significant improvement in all clinical and radiographic parameters. However, on intergroup comparison of the same, there was no statistically significant difference between test and control sites at any interval. Although test sites showed slightly higher amount of bone fill, it was not statistically significant. There was a significant reduction in the counts of Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis at both sites from baseline to 3 months. In addition, there was a significant reduction at test sites as compared to control sites at 3-month follow-up (P = 0.003 and P = 0.013). Conclusion: The reduction in microbial counts found in test sites at 3-month follow-up could not bring similar significant improvements in the clinical and radiographic parameters though the test sites showed slightly higher bone fill. PMID:27630501

Microfinance investments in quality at private clinics in Uganda: a case-control study.

PubMed

Seiber, Eric E; Robinson, Amara L

2007-10-18

Small private-sector health care providers can play an important role in meeting the developing country health care needs, but a lack of credit can prove major constraint to small-provider expansion. This study examines the potential of small, microfinance loans to strengthen the private health sector and improve access to quality preventive and curative health services in Uganda. This study estimates logistic regressions using 2,387 client exit interviews to assess the impact of microfinance loans on perceived quality and the viability and sustainability of small, private clinics. The study finds perceived quality improved with loan recipients' clients being more likely to choose clinics on the basis of drug availability, fair charges, cleanliness, and confidentiality. In addition, the assessment found evidence of increased client flows, but the changes produced mixed results for sustainability with respondents being only half as likely to "always" visit a particular clinic. The results indicate that the microfinance program improved perceived quality at loan recipient clinics, especially as reliable drug outlets.

Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial.

PubMed

Tonttila, Panu P; Lantto, Juha; Pääkkö, Eija; Piippo, Ulla; Kauppila, Saila; Lammentausta, Eveliina; Ohtonen, Pasi; Vaarala, Markku H

2016-03-01

Multiparametric magnetic resonance imaging (MP-MRI) may improve the detection of clinically significant prostate cancer (PCa). To compare MP-MRI transrectal ultrasound (TRUS)-fusion targeted biopsy with routine TRUS-guided random biopsy for overall and clinically significant PCa detection among patients with suspected PCa based on prostate-specific antigen (PSA) values. This institutional review board-approved, single-center, prospective, randomized controlled trial (April 2011 to December 2014) included 130 biopsy-naive patients referred for prostate biopsy based on PSA values (PSA <20 ng/ml or free-to-total PSA ratio ≤0.15 and PSA <10 ng/ml). Patients were randomized 1:1 to the MP-MRI or control group. Patients in the MP-MRI group underwent prebiopsy MP-MRI followed by 10- to 12-core TRUS-guided random biopsy and cognitive MRI/TRUS fusion targeted biopsy. The control group underwent TRUS-guided random biopsy alone. MP-MRI 3-T phased-array surface coil. The primary outcome was the number of patients with biopsy-proven PCa in the MP-MRI and control groups. Secondary outcome measures included the number of positive prostate biopsies and the proportion of clinically significant PCa in the MP-MRI and control groups. Between-group analyses were performed. Overall, 53 and 60 patients were evaluable in the MP-MRI and control groups, respectively. The overall PCa detection rate and the clinically significant cancer detection rate were similar between the MP-MRI and control groups, respectively (64% [34 of 53] vs 57% [34 of 60]; 7.5% difference [95% confidence interval (CI), -10 to 25], p=0.5, and 55% [29 of 53] vs 45% [27 of 60]; 9.7% difference [95% CI, -8.5 to 27], p=0.8). The PCa detection rate was higher than assumed during the planning of this single-center trial. MP-MRI/TRUS-fusion targeted biopsy did not improve PCa detection rate compared with TRUS-guided biopsy alone in patients with suspected PCa based on PSA values. In this randomized clinical trial, additional prostate magnetic resonance imaging (MRI) before prostate biopsy appeared to offer similar diagnostic accuracy compared with routine transrectal ultrasound-guided random biopsy in the diagnosis of prostate cancer. Similar numbers of cancers were detected with and without MRI. ClinicalTrials.gov identifier: NCT01357512. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Vitamin K for upper gastrointestinal bleeding in people with acute or chronic liver diseases.

PubMed

Martí-Carvajal, Arturo J; Solà, Ivan

2015-06-09

Upper gastrointestinal bleeding is one of the most frequent causes of morbidity and mortality in the course of liver cirrhosis. Several treatments are used for upper gastrointestinal bleeding in people with liver diseases. One of them is vitamin K administration, but it is not known whether it benefits or harms people with acute or chronic liver disease and upper gastrointestinal bleeding. This is an update of this Cochrane review. To assess the beneficial and harmful effects of vitamin K for people with acute or chronic liver disease and upper gastrointestinal bleeding. We searched The Cochrane Hepato-Biliary Controlled Trials Register (February 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2 of 12, 2015), MEDLINE (Ovid SP) (1946 to February 2015), EMBASE (Ovid SP) (1974 to February 2015), Science Citation Index EXPANDED (1900 to February 2015), and LILACS (1982 to 25 February 2015). We sought additional randomised trials from two registries of clinical trials: the World Health Organization Clinical Trials Search Portal and the metaRegister of Controlled Trials. We looked through the reference lists of the retrieved publications and review articles. Randomised clinical trials irrespective of blinding, language, or publication status for assessment of benefits and harms. We considered observational studies for assessment of harms only. \\We aimed to summarise data from randomised clinical trials using Standard Cochrane methodology and assess them according to the GRADE approach. We found no randomised trials on vitamin K for upper gastrointestinal bleeding in people with liver diseases assessing benefits and harms of the intervention. We identified no quasi-randomised studies, historically controlled studies, or observational studies assessing harms. This updated review found no randomised clinical trials of vitamin K for upper gastrointestinal bleeding in people with liver diseases. The benefits and harms of vitamin K need to be tested in randomised clinical trials. Until randomised clinical trials are conducted to assess the trade-off between benefits and harms, we cannot recommend or refute the use of vitamin K for upper gastrointestinal bleeding in people with liver diseases.

Adjunctive Effect of Autologus Platelet-Rich Fibrin to Barrier Membrane in the Treatment of Periodontal Intrabony Defects.

PubMed

Panda, Saurav; Sankari, Malaiappan; Satpathy, Anurag; Jayakumar, Doraiswamy; Mozzati, Marco; Mortellaro, Carmen; Gallesio, Giorgia; Taschieri, Silvio; Del Fabbro, Massimo

2016-05-01

Autologous platelet-rich fibrin (PRF) and barrier membranes in the treatment of intrabony defects in chronic periodontitis patients have shown significant clinical benefits. This study evaluates the additive effect of autologous PRF in combination with a barrier membrane versus the use of barrier membrane alone for the treatment of intrabony defects in chronic periodontitis patients. A randomized split-mouth design was used. Sixteen patients with 32 paired intrabony defects were included. In each patient 1 defect was treated using a resorbable collagen membrane along with PRF (test group) and the other defect by guided tissue regeneration alone (control group). The following clinical parameters were measured at baseline and after 9 months: plaque index, modified sulcus bleeding index, probing pocket depth, clinical attachment level, and gingival marginal level. The radiographic defect depth was also assessed at baseline and after 9 months. Test group showed a statistically significant improvement for probing depth (P = 0.002), clinical attachment level (P = 0.001), and radiographic defect depth (P < 0.001) after 9 months as compared with the control sites. Radiographic defect depth reduction was 58.19 ± 13.24% in the test group as compared with 24.86 ± 9.94% reduction in the control group. The adjunctive use of PRF in combination with barrier membrane is more effective in the treatment of intrabony defects in chronic periodontitis as compared with barrier membrane alone.

Effects of platelet-rich fibrin on healing of intra-bony defects treated with anorganic bovine bone mineral.

PubMed

Sezgin, Yasemin; Uraz, Ahu; Taner, I Levent; Çulhaoğlu, Rana

2017-01-26

Anorganic bovine bone mineral (ABBM) is extensively used in the treatment of intra-bony defects. Platelet-rich fibrin (PRF) is a new-generation platelet concentrate with a simplified technique. Although certain studies have reported the use of PRF in the treatment of intra-bony defects, to date, none of them have evaluated its additive effects with ABBM. Therefore, a randomised, split-mouth clinical trial was conducted to compare healing of intra-bony defects treated with an ABBM-PRF combination with healing of those treated with ABBM alone. By using a split-mouth design, 15 paired intra-bony defects were randomly treated with either ABBM alone (control group) or ABBM-PRF combination (test group). Following clinical parameters and radiographical measurements were recorded at baseline and 6 months after treatment: plaque index (PI), gingival index (GI), probing depth (PD), gingival recession (GR), clinical attachment level (CAL), vertical bone loss, depth of defect and defect angle. Preoperative clinical and radiographical measurements were similar for the test and control groups. Statistically significant reductions in GI, PD, CAL, vertical bone loss, depth of intra-bony defect and widening of defect angle were detected after treatment in both groups. With respect to inter-group analysis, gain in CAL was significantly greater in the test group than in the control group, whereas no inter-group differences were observed in any other parameter. The results of this study indicate that both therapies are effective in the treatment of intra-bony defects.

Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

PubMed

Becker, Jan; Beutel, Manfred E; Gerzymisch, Katharina; Schulz, Dirk; Siepmann, Martin; Knickenberg, Rudolf J; Schmädeke, Stefan; Ferdinand, Peter; Zwerenz, Rüdiger

2016-06-13

Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation. All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to log in to the study platform together with the usual clinic information leaflet. Patients will receive the study information and informed consent upon login and will be randomized into the intervention or the control group. The intervention group (n = 394) will get access to our virtual online clinic, containing several videos about inpatient rehabilitation, until their admission to inpatient rehabilitation. The control group (n = 394) will receive no special treatment preparation. Questionnaires will be given at study inclusion (T0), two weeks before admission to (T1), and at the end of (T2) inpatient rehabilitation. The primary outcome is the outcome expectancy measured with the Credibility Expectancy Questionnaire at T1. Secondary outcomes include treatment motivation, mental health, work ability, depression, anxiety, and satisfaction with and usage of the Internet platform. We expect the intervention group to benefit from the additional preparation concerning their outcome expectancy. If successful, this approach could be used in the future to enhance the efficacy of inpatient rehabilitation. ClinicalTrials.gov: NCT02532881 . Registered on 25 August 2015.

Effects of mindfulness-based cognitive therapy on neurophysiological correlates of performance monitoring in adult attention-deficit/hyperactivity disorder.

PubMed

Schoenberg, Poppy L A; Hepark, Sevket; Kan, Cornelis C; Barendregt, Henk P; Buitelaar, Jan K; Speckens, Anne E M

2014-07-01

To examine whether mindfulness-based cognitive therapy (MBCT) would enhance attenuated amplitudes of event-related potentials (ERPs) indexing performance monitoring biomarkers of attention-deficit/hyperactivity disorder (ADHD). Fifty adult ADHD patients took part in a randomised controlled study investigating ERP and clinical measures pre-to-post MBCT. Twenty-six patients were randomly allocated to MBCT, 24 to a wait-list control. Main outcome measures included error processing (ERN, Pe), conflict monitoring (NoGo-N2), and inhibitory control (NoGo-P3) ERPs concomitant to a continuous performance task (CPT-X). Inattention and hyperactivity-impulsivity ADHD symptoms, psychological distress and social functioning, and mindfulness skills were also assessed. MBCT was associated with increased Pe and NoGo-P3 amplitudes, coinciding with reduced 'hyperactivity/impulsivity' and 'inattention' symptomatology. Specific to the MBCT; enhanced Pe amplitudes correlated with a decrease in hyperactivity/impulsivity symptoms and increased 'act-with-awareness' mindfulness skill, whereas, enhanced P3 correlated with amelioration in inattention symptoms. MBCT enhanced ERP amplitudes associated with motivational saliency and error awareness, leading to improved inhibitory regulation. MBCT suggests having comparable modulation on performance monitoring ERP amplitudes as pharmacological treatments. Further study and development of MBCT as a treatment for ADHD is warranted, in addition to its potential scope for clinical applicability to broader defined externalising disorders and clinical problems associated with impairments of the prefrontal cortex. Copyright © 2013 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Treatment of neonatal calf diarrhea with an oral electrolyte solution supplemented with psyllium mucilloid.

PubMed

Cebra, M L; Garry, F B; Cebra, C K; Adams, R; McCann, J P; Fettman, M J

1998-01-01

Dairy calves under 14 days of age with naturally occurring, uncomplicated diarrhea were treated for 3 days with a hypertonic oral electrolyte solution with (n = 15) or without (n = 12) psyllium. Clinical response and clinical pathology data were compared between the 2 groups. Glucose absorption was evaluated on days 1 and 3 by measurement of plasma glucose and lactate and serum insulin concentrations for 4 hours after formula administration. On day 1, glucose, lactate, and insulin concentrations were lower in psyllium-fed calves than in control calves, with significant differences noted in glucose and lactate concentrations at several time points (P < 0.05). Plasma lactate concentrations were higher at several times in both treatment groups on day 3 than on day 1 (P < 0.05). Fecal consistency was markedly different in psyllium-fed calves as compared with control calves within 24 hours of psyllium supplementation. Fecal percent dry matter content was lower in psyllium-fed calves than in control calves at least once a day during supplementation and on day 3 compared with day 0 in the psyllium-fed calves (P < 0.05). There were no significant differences in clinical performance scores, hydration status, arterial blood gas, serum anion gap, electrolyte, or total CO2 concentrations. Addition of psyllium to an oral electrolyte solution resulted in immediate alterations in glucose absorption without impairing rehydration in diarrheic calves, but differences were transient and did not affect clinical outcome.

Pain and motor control: From the laboratory to rehabilitation.

PubMed

Hodges, Paul W

2011-04-01

Movement is changed in pain and is the target of clinical interventions. Yet the understanding of the physiological basis for movement adaptation in pain remains limited. Contemporary theories are relatively simplistic and fall short of providing an explanation for the variety of permutations of changes in movement control identified in clinical and experimental contexts. The link between current theories and rehabilitation is weak at best. New theories are required that both account for the breadth of changes in motor control in pain and provide direction for development and refinement of clinical interventions. This paper describes an expanded theory of the motor adaptation to pain to address these two issues. The new theory, based on clinical and experimental data argues that: activity is redistributed within and between muscles rather than stereotypical inhibition or excitation of muscles; modifies the mechanical behaviour in a variable manner with the objective to "protect" the tissues from further pain or injury, or threatened pain or injury; involves changes at multiple levels of the motor system that may be complementary, additive or competitive; and has short-term benefit, but with potential long-term consequences due to factors such as increased load, decreased movement, and decreased variability. This expanded theory provides guidance for rehabilitation directed at alleviating a mechanical contribution to the recurrence and persistence of pain that must be balanced with other aspects of a multifaceted intervention that includes management of psychosocial aspects of the pain experience. Copyright © 2011 Elsevier Ltd. All rights reserved.

Oral Quercetin Supplementation Enhances Adiponectin Receptor Transcript Expression in Polycystic Ovary Syndrome Patients: A Randomized Placebo-Controlled Double-Blind Clinical Trial

PubMed Central

Rezvan, Neda; Moini, Ashraf; Gorgani-Firuzjaee, Sattar; Hosseinzadeh-Attar, Mohammad Javad

2018-01-01

Objective Polycystic ovary syndrome (PCOS), an ovarian-pituitary axis androgen disorder, is a common endocrine disease in women. Obesity-induced androgenesis and imbalance of adipokine secretion may lead to some metabolic features of PCOS. The beneficial effects of polyphenolic compounds such as quercetin have been reported, however, the underlying molecular mechanism is not entirely understood. In the present study, we investigated the effect of quercetin supplementation on the expression of adiponectin receptors at the transcript level in peripheral blood mononuclear cells (PBMC) samples of PCOS patients. Materials and Methods In this randomized clinical trial, 84 PCOS subjects were randomly assigned to two groups; the treatment group received 1 g quercetin (two 500 mg capsules) daily for 12 weeks and the control group received placebo. To examine the effect of quercetin supplementation on PCOS patients in addition to biochemical and anthropometric assessments, the expression of ADIPOR1 and ADIPOR2 at the transcript level and AMPK level were determined by quantitative reverse transcription-polymerase chain reaction (RT-qPCR) and ELISA assays respectively. Results Oral quercetin supplementation significantly increased ADIPOR1 and ADIPOR2 transcript expression by 1.32- and 1.46-fold respecetively (P<0.01). In addition, quercetin supplementation enhanced AMPK level by 12.3% compared with the control group (P<0.05). Conclusion Oral quercetin supplementation improves the metabolic features of PCOS patients by upregulating the expression of adiponectin receptors and AMPK (Registration Number: IRCT2013112515536N1). PMID:29105398

Is video review of patient encounters an effective tool for medical student learning? A review of the literature

PubMed Central

Hammoud, Maya M; Morgan, Helen K; Edwards, Mary E; Lyon, Jennifer A; White, Casey

2012-01-01

Purpose To determine if video review of student performance during patient encounters is an effective tool for medical student learning. Methods Multiple bibliographic databases that include medical, general health care, education, psychology, and behavioral science literature were searched for the following terms: medical students, medical education, undergraduate medical education, education, self-assessment, self-evaluation, self-appraisal, feedback, videotape, video recording, televised, and DVD. The authors examined all abstracts resulting from this search and reviewed the full text of the relevant articles as well as additional articles identified in the reference lists of the relevant articles. Studies were classified by year of student (preclinical or clinical) and study design (controlled or non-controlled). Results A total of 67 articles met the final search criteria and were fully reviewed. Most studies were non-controlled and performed in the clinical years. Although the studies were quite variable in quality, design, and outcomes, in general video recording of performance and subsequent review by students with expert feedback had positive outcomes in improving feedback and ultimate performance. Video review with self-assessment alone was not found to be generally effective, but when linked with expert feedback it was superior to traditional feedback alone. Conclusion There are many methods for integrating effective use of video-captured performance into a program of learning. We recommend combining student self-assessment with feedback from faculty or other trained individuals for maximum effectiveness. We also recommend additional research in this area. PMID:23761999

Direct peritoneal resuscitation improves obesity-induced hepatic dysfunction after trauma.

PubMed

Matheson, Paul J; Franklin, Glen A; Hurt, Ryan T; Downard, Cynthia D; Smith, Jason W; Garrison, Richard N

2012-04-01

The metabolic syndrome and associated fatty liver disease are thought to contribute to poor outcomes in trauma patients. Experimentally, obesity compromises liver blood flow. We sought to correlate the effect of obesity, injury severity, and liver dysfunction with trauma outcomes. We hypothesized that obesity-related liver dysfunction could be mitigated with the novel technique of adjunctive direct peritoneal resuscitation (DPR). This study has clinical and experimental arms. The clinical study was a case-controlled retrospective analysis of ICU trauma patients (n = 72 obese, n = 187 nonobese). The experimental study was a hemorrhagic shock model in obese rats to assess the effect of DPR on liver blood flow, liver function, and inflammatory mediators. In trauma patients, univariate and multivariate analyses demonstrated increasing mortality (p < 0.05), septic complications (p < 0.05), liver dysfunction (p < 0.001), and renal impairment (p < 0.05) with increasing body mass index and injury severity score. Obesity in rats impairs liver blood flow, liver function, renal function, and inflammation (interleukin [IL]-1β, IL-6, high mobility group protein B1[HMGB-1]). The addition of DPR to shock resuscitation restores liver blood flow, improves organ function, and reverses the systemic proinflammatory response. Our clinical review substantiates that obesity worsens trauma outcomes regardless of injury severity. Obesity-related liver and renal dysfunction is aggravated by injury severity. In an obese rat model of resuscitated hemorrhagic shock, the addition of DPR abrogates trauma-induced liver, renal, and inflammatory responses. We conclude that the addition of DPR to the clinical resuscitation regimen will benefit the obese trauma patient. Published by Elsevier Inc.

Branched-chain amino acids for people with hepatic encephalopathy.

PubMed

Gluud, Lise Lotte; Dam, Gitte; Les, Iñigo; Córdoba, Juan; Marchesini, Giulio; Borre, Mette; Aagaard, Niels Kristian; Vilstrup, Hendrik

2015-02-25

Hepatic encephalopathy is a brain dysfunction with neurological and psychiatric changes associated with liver insufficiency or portal-systemic shunting. The severity ranges from minor symptoms to coma. A Cochrane systematic review including 11 randomised clinical trials on branched-chain amino acids (BCAA) versus control interventions has evaluated if BCAA may benefit people with hepatic encephalopathy. To evaluate the beneficial and harmful effects of BCAA versus any control intervention for people with hepatic encephalopathy. We identified trials through manual and electronic searches in The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index on 2 October 2014. We included randomised clinical trials, irrespective of the bias control, language, or publication status. The authors independently extracted data based on published reports and collected data from the primary investigators. We changed our primary outcomes in this update of the review to include mortality (all cause), hepatic encephalopathy (number of people without improved manifestations of hepatic encephalopathy), and adverse events. The analyses included random-effects and fixed-effect meta-analyses. We performed subgroup, sensitivity, regression, and trial sequential analyses to evaluate sources of heterogeneity (including intervention, and participant and trial characteristics), bias (using The Cochrane Hepato-Biliary Group method), small-study effects, and the robustness of the results after adjusting for sparse data and multiplicity. We graded the quality of the evidence using the GRADE approach. We found 16 randomised clinical trials including 827 participants with hepatic encephalopathy classed as overt (12 trials) or minimal (four trials). Eight trials assessed oral BCAA supplements and seven trials assessed intravenous BCAA. The control groups received placebo/no intervention (two trials), diets (10 trials), lactulose (two trials), or neomycin (two trials). In 15 trials, all participants had cirrhosis. Based on the combined Cochrane Hepato-Biliary Group score, we classed seven trials as low risk of bias and nine trials as high risk of bias (mainly due to lack of blinding or for-profit funding). In a random-effects meta-analysis of mortality, we found no difference between BCAA and controls (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.69 to 1.11; 760 participants; 15 trials; moderate quality of evidence). We found no evidence of small-study effects. Sensitivity analyses of trials with a low risk of bias found no beneficial or detrimental effect of BCAA on mortality. Trial sequential analysis showed that the required information size was not reached, suggesting that additional evidence was needed. BCAA had a beneficial effect on hepatic encephalopathy (RR 0.73, 95% CI 0.61 to 0.88; 827 participants; 16 trials; high quality of evidence). We found no small-study effects and confirmed the beneficial effect of BCAA in a sensitivity analysis that only included trials with a low risk of bias (RR 0.71, 95% CI 0.52 to 0.96). The trial sequential analysis showed that firm evidence was reached. In a fixed-effect meta-analysis, we found that BCAA increased the risk of nausea and vomiting (RR 5.56; 2.93 to 10.55; moderate quality of evidence). We found no beneficial or detrimental effects of BCAA on nausea or vomiting in a random-effects meta-analysis or on quality of life or nutritional parameters. We did not identify predictors of the intervention effect in the subgroup, sensitivity, or meta-regression analyses. In sensitivity analyses that excluded trials with a lactulose or neomycin control, BCAA had a beneficial effect on hepatic encephalopathy (RR 0.76, 95% CI 0.63 to 0.92). Additional sensitivity analyses found no difference between BCAA and lactulose or neomycin (RR 0.66, 95% CI 0.34 to 1.30). In this updated review, we included five additional trials. The analyses showed that BCAA had a beneficial effect on hepatic encephalopathy. We found no effect on mortality, quality of life, or nutritional parameters, but we need additional trials to evaluate these outcomes. Likewise, we need additional randomised clinical trials to determine the effect of BCAA compared with interventions such as non-absorbable disaccharides, rifaximin, or other antibiotics.

Branched-chain amino acids for people with hepatic encephalopathy.

PubMed

Gluud, Lise Lotte; Dam, Gitte; Les, Iñigo; Marchesini, Giulio; Borre, Mette; Aagaard, Niels Kristian; Vilstrup, Hendrik

2017-05-18

Hepatic encephalopathy is a brain dysfunction with neurological and psychiatric changes associated with liver insufficiency or portal-systemic shunting. The severity ranges from minor symptoms to coma. A Cochrane systematic review including 11 randomised clinical trials on branched-chain amino acids (BCAA) versus control interventions has evaluated if BCAA may benefit people with hepatic encephalopathy. To evaluate the beneficial and harmful effects of BCAA versus any control intervention for people with hepatic encephalopathy. We identified trials through manual and electronic searches in The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded and Conference Proceedings Citation Index - Science, and LILACS (May 2017). We included randomised clinical trials, irrespective of the bias control, language, or publication status. The authors independently extracted data based on published reports and collected data from the primary investigators. We changed our primary outcomes in this update of the review to include mortality (all cause), hepatic encephalopathy (number of people without improved manifestations of hepatic encephalopathy), and adverse events. The analyses included random-effects and fixed-effect meta-analyses. We performed subgroup, sensitivity, regression, and trial sequential analyses to evaluate sources of heterogeneity (including intervention, and participant and trial characteristics), bias (using The Cochrane Hepato-Biliary Group method), small-study effects, and the robustness of the results after adjusting for sparse data and multiplicity. We graded the quality of the evidence using the GRADE approach. We found 16 randomised clinical trials including 827 participants with hepatic encephalopathy classed as overt (12 trials) or minimal (four trials). Eight trials assessed oral BCAA supplements and seven trials assessed intravenous BCAA. The control groups received placebo/no intervention (two trials), diets (10 trials), lactulose (two trials), or neomycin (two trials). In 15 trials, all participants had cirrhosis. We classed seven trials as low risk of bias and nine trials as high risk of bias (mainly due to lack of blinding or for-profit funding). In a random-effects meta-analysis of mortality, we found no difference between BCAA and controls (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.69 to 1.11; 760 participants; 15 trials; moderate quality of evidence). We found no evidence of small-study effects. Sensitivity analyses of trials with a low risk of bias found no beneficial or detrimental effect of BCAA on mortality. Trial sequential analysis showed that the required information size was not reached, suggesting that additional evidence was needed. BCAA had a beneficial effect on hepatic encephalopathy (RR 0.73, 95% CI 0.61 to 0.88; 827 participants; 16 trials; high quality of evidence). We found no small-study effects and confirmed the beneficial effect of BCAA in a sensitivity analysis that only included trials with a low risk of bias (RR 0.71, 95% CI 0.52 to 0.96). The trial sequential analysis showed that firm evidence was reached. In a fixed-effect meta-analysis, we found that BCAA increased the risk of nausea and vomiting (RR 5.56; 2.93 to 10.55; moderate quality of evidence). We found no beneficial or detrimental effects of BCAA on nausea or vomiting in a random-effects meta-analysis or on quality of life or nutritional parameters. We did not identify predictors of the intervention effect in the subgroup, sensitivity, or meta-regression analyses. In sensitivity analyses that excluded trials with a lactulose or neomycin control, BCAA had a beneficial effect on hepatic encephalopathy (RR 0.76, 95% CI 0.63 to 0.92). Additional sensitivity analyses found no difference between BCAA and lactulose or neomycin (RR 0.66, 95% CI 0.34 to 1.30). In this updated review, we included five additional trials. The analyses showed that BCAA had a beneficial effect on hepatic encephalopathy. We found no effect on mortality, quality of life, or nutritional parameters, but we need additional trials to evaluate these outcomes. Likewise, we need additional randomised clinical trials to determine the effect of BCAA compared with interventions such as non-absorbable disaccharides, rifaximin, or other antibiotics.

Branched-chain amino acids for people with hepatic encephalopathy.

PubMed

Gluud, Lise Lotte; Dam, Gitte; Les, Iñigo; Córdoba, Juan; Marchesini, Giulio; Borre, Mette; Aagaard, Niels Kristian; Vilstrup, Hendrik

2015-09-17

Hepatic encephalopathy is a brain dysfunction with neurological and psychiatric changes associated with liver insufficiency or portal-systemic shunting. The severity ranges from minor symptoms to coma. A Cochrane systematic review including 11 randomised clinical trials on branched-chain amino acids (BCAA) versus control interventions has evaluated if BCAA may benefit people with hepatic encephalopathy. To evaluate the beneficial and harmful effects of BCAA versus any control intervention for people with hepatic encephalopathy. We identified trials through manual and electronic searches in The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index (August 2015). We included randomised clinical trials, irrespective of the bias control, language, or publication status. The authors independently extracted data based on published reports and collected data from the primary investigators. We changed our primary outcomes in this update of the review to include mortality (all cause), hepatic encephalopathy (number of people without improved manifestations of hepatic encephalopathy), and adverse events. The analyses included random-effects and fixed-effect meta-analyses. We performed subgroup, sensitivity, regression, and trial sequential analyses to evaluate sources of heterogeneity (including intervention, and participant and trial characteristics), bias (using The Cochrane Hepato-Biliary Group method), small-study effects, and the robustness of the results after adjusting for sparse data and multiplicity. We graded the quality of the evidence using the GRADE approach. We found 16 randomised clinical trials including 827 participants with hepatic encephalopathy classed as overt (12 trials) or minimal (four trials). Eight trials assessed oral BCAA supplements and seven trials assessed intravenous BCAA. The control groups received placebo/no intervention (two trials), diets (10 trials), lactulose (two trials), or neomycin (two trials). In 15 trials, all participants had cirrhosis. We classed seven trials as low risk of bias and nine trials as high risk of bias (mainly due to lack of blinding or for-profit funding). In a random-effects meta-analysis of mortality, we found no difference between BCAA and controls (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.69 to 1.11; 760 participants; 15 trials; moderate quality of evidence). We found no evidence of small-study effects. Sensitivity analyses of trials with a low risk of bias found no beneficial or detrimental effect of BCAA on mortality. Trial sequential analysis showed that the required information size was not reached, suggesting that additional evidence was needed. BCAA had a beneficial effect on hepatic encephalopathy (RR 0.73, 95% CI 0.61 to 0.88; 827 participants; 16 trials; high quality of evidence). We found no small-study effects and confirmed the beneficial effect of BCAA in a sensitivity analysis that only included trials with a low risk of bias (RR 0.71, 95% CI 0.52 to 0.96). The trial sequential analysis showed that firm evidence was reached. In a fixed-effect meta-analysis, we found that BCAA increased the risk of nausea and vomiting (RR 5.56; 2.93 to 10.55; moderate quality of evidence). We found no beneficial or detrimental effects of BCAA on nausea or vomiting in a random-effects meta-analysis or on quality of life or nutritional parameters. We did not identify predictors of the intervention effect in the subgroup, sensitivity, or meta-regression analyses. In sensitivity analyses that excluded trials with a lactulose or neomycin control, BCAA had a beneficial effect on hepatic encephalopathy (RR 0.76, 95% CI 0.63 to 0.92). Additional sensitivity analyses found no difference between BCAA and lactulose or neomycin (RR 0.66, 95% CI 0.34 to 1.30). In this updated review, we included five additional trials. The analyses showed that BCAA had a beneficial effect on hepatic encephalopathy. We found no effect on mortality, quality of life, or nutritional parameters, but we need additional trials to evaluate these outcomes. Likewise, we need additional randomised clinical trials to determine the effect of BCAA compared with interventions such as non-absorbable disaccharides, rifaximin, or other antibiotics.

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

PubMed

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

2011-11-01

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

Sub-clinical Alcohol Consumption and Gambling Disorder

PubMed Central

Harries, Michael D.; Redden, Sarah A.; Leppink, Eric W.; Chamberlain, Samuel R.; Grant, Jon E.

2017-01-01

While it is well established that gambling disorder is associated with alcohol use disorder, less is known regarding whether sub-clinical alcohol consumption increases gambling behavior. This study examined the effects of varying levels of alcohol consumption on clinical and cognitive measures. The sample consisted of 572 non-treatment seeking gamblers age 18-29 who were divided into three groups: non-current drinkers, current drinkers who did not qualify for an alcohol use disorder, and those with an alcohol use disorder (AUD). All subjects were assessed on gambling pathology, severity and impulsivity using the Structured Clinical Interview for Gambling Disorder, Yale Brown Obsessive Compulsive Scale for Pathologic Gambling and the Barratt Impulsive Scale-11 and select cognitive tests. In all of the clinical measures, controlling for age, gender and education, the AUD group was significantly more likely than the non-current and current drinkers to be a pathologic gambler and to be impulsive, compulsive and depressed. On cognitive tasks, controlling for age, gender and education, the AUD group had significantly worse strategy use on a spatial working memory task than both other groups. This study suggests that the relationship between alcohol and gambling may only exist when pathology in both alcohol consumption and gambling behavior is present. Examining this relationship with alcohol consumption as a continuous variable would provide additional insight into the potential effects alcohol consumption has on gambling behavior. PMID:27826730