Army Study Shows Decline In Behavioral Health Stigma

DTIC Science & Technology

2012-01-01

Army Study Shows Decline in Behavioral Health Stigma By Rob McIlvaine Army News Service WASHINGTON, Jan. 20, 2012 - A newly released Army study on...conference yesterday. The three-year study outlines the problem of suicide in the Army and related issues of substance abuse, spouse abuse and child abuse...REPORT TYPE 3. DATES COVERED 00-00-2012 to 00-00-2012 4. TITLE AND SUBTITLE Army Study Shows Decline In Behavioral Health Stigma 5a. CONTRACT

A Preliminary Study of Clinical Abbreviation Disambiguation in Real Time.

PubMed

Wu, Y; Denny, J C; Rosenbloom, S T; Miller, R A; Giuse, D A; Song, M; Xu, H

2015-01-01

To save time, healthcare providers frequently use abbreviations while authoring clinical documents. Nevertheless, abbreviations that authors deem unambiguous often confuse other readers, including clinicians, patients, and natural language processing (NLP) systems. Most current clinical NLP systems "post-process" notes long after clinicians enter them into electronic health record systems (EHRs). Such post-processing cannot guarantee 100% accuracy in abbreviation identification and disambiguation, since multiple alternative interpretations exist. Authors describe a prototype system for real-time Clinical Abbreviation Recognition and Disambiguation (rCARD) - i.e., a system that interacts with authors during note generation to verify correct abbreviation senses. The rCARD system design anticipates future integration with web-based clinical documentation systems to improve quality of healthcare records. When clinicians enter documents, rCARD will automatically recognize each abbreviation. For abbreviations with multiple possible senses, rCARD will show a ranked list of possible meanings with the best predicted sense at the top. The prototype application embodies three word sense disambiguation (WSD) methods to predict the correct senses of abbreviations. We then conducted three experments to evaluate rCARD, including 1) a performance evaluation of different WSD methods; 2) a time evaluation of real-time WSD methods; and 3) a user study of typing clinical sentences with abbreviations using rCARD. Using 4,721 sentences containing 25 commonly observed, highly ambiguous clinical abbreviations, our evaluation showed that the best profile-based method implemented in rCARD achieved a reasonable WSD accuracy of 88.8% (comparable to SVM - 89.5%) and the cost of time for the different WSD methods are also acceptable (ranging from 0.630 to 1.649 milliseconds within the same network). The preliminary user study also showed that the extra time costs by rCARD were about 5% of total

Poor relation between biomechanical and clinical studies for the proximal femoral locking compression plate

PubMed Central

Viberg, Bjarke; Rasmussen, Katrine M V; Overgaard, Søren; Rogmark, Cecilia

2017-01-01

Background and purpose The proximal femur locking compression plate (PF-LCP) is a new concept in the treatment of hip fractures. When releasing new implants onto the market, biomechanical studies are conducted to evaluate performance of the implant. We investigated the relation between biomechanical and clinical studies on PF-LCP. Methods A systematic literature search of relevant biomechanical and clinical studies was conducted in PubMed on December 1, 2015. 7 biomechanical studies and 15 clinical studies were included. Results Even though the biomechanical studies showed equivalent or higher failure loads for femoral neck fracture, the clinical results were far worse, with a 37% complication rate. There were no biomechanical studies on pertrochanteric fractures. Biomechanical studies on subtrochanteric fractures showed that PF-LCP had a lower failure load than with proximal femoral nail, but higher than with angled blade plate. 4 clinical studies had complication rates less than 8% and 9 studies had complication rates between 15% and 53%. Interpretation There was no clear relation between biomechanical and clinical studies. Biomechanical studies are generally inherently different from clinical studies, as they examine the best possible theoretical use of the implant without considering the long-term outcome in a clinical setting. Properly designed clinical studies are mandatory when introducing new implants, and they cannot be replaced by biomechanical studies. PMID:28287002

Gram stain method shows better sensitivity than clinical criteria for detection of bacterial vaginosis in surveillance of pregnant, low-income women in a clinical setting.

PubMed Central

Tam, M T; Yungbluth, M; Myles, T

1998-01-01

OBJECTIVE: The purpose of the study is to determine whether the Gram stain method is superior to the clinical criteria for the diagnosis of bacterial vaginosis in low-income pregnant women seen in a resident clinic setting. The clinical criteria is the current diagnostic method employed to diagnose bacterial vaginosis. STUDY DESIGN: In this study, 51 pregnant women with vaginal discharge were prospectively evaluated. All were screened using the clinical criteria, Gram stain method, and culture of the discharge. The modified scoring system instituted by Nugent et al. (J Clin Microbiol 29:297-301, 1991) was employed in reading the Gram stain smears. The clinical criteria were then compared with the Gram stain method. Isolation of moderate to many Gardnerella vaginalis growth by culture was used as the confirmatory finding. RESULTS: Sensitivity of the Gram stain method (91%) was significantly higher than that of the clinical criteria (46%), (sign test P = 0.0023, < 0.01). The Gram stain method also has both a low false-negative (4%) and high negative predictive value (96%), making it an ideal diagnostic test. CONCLUSION: The Gram stain method is a rapid and cost-effective test that is also highly reproducible and readily available in many laboratories. These features make the Gram stain method a more desirable screening procedure for bacterial vaginosis in a clinic population. PMID:9894174

Clinical trial shows lasting function of a new moisturizing cream against vaginal dryness.

PubMed

Henneicke-von Zepelin, Hans-Heinrich; Williams, Ragna; Havemeister, Wiebke; Wigger-Alberti, Walter; Nolte, Klaus-Ulrich

2017-05-01

Vaginal dryness and associated symptoms may occur in women of any age and are a frequent burden after menopause. The North American Menopause Society recommends long-acting non-hormonal vaginal creams as first-line therapy. A new type of such creams was developed (Remifemin® FeuchtCreme in Austria and Germany). This hormone-free cream contains hamamelis virginiana distillate and well-established vaginal cream ingredients. We explored its physical function and tolerability in an open interventional clinical trial. 20 postmenopausal women (54 to 76 years, median 60) treated their vaginal dryness using this cream once daily for 7 days and reported about their symptoms before, 4 to 8 h after first and 14 to 22 h after last application. A physician assessed tolerability and local physical function. All patients completed the study. Local physical function significantly improved from dryness at baseline (mean 4.0 ± SD 1.8) to a normal moisture level, on average (6.3 ± 2.1 after first, 6.7 ± 2.1 after last application, p = 0.0001). Subjective assessment of a feeling vaginal dryness showed a significant improvement at both times (p = 0.0001). Onset and duration of feeling moisturized were reported to be 0 to 2 min and 11.3 ± 6.9 h after application. All women reported vaginal dryness at baseline. 55 and 80% of patients reported no dryness after first application and at the end of the investigation. The cream was seen at the application site for up to 21 h. Tolerability assessments did not reveal any relevant change over time. There were four adverse events in 4 patients, all not serious and of mild intensity: urinary urgency (2), diarrhoea (1) and mild spotting after first application (1). The latter was caused by the dry surface of the applicator and was avoided by moisturizing the surface of the applicator at subsequent applications. In conclusion, these study results indicate a well-tolerated and long-acting function of this new

Second Mesiobuccal Canal Treatment in a Predoctoral Dental Clinic: A Retrospective Clinical Study.

PubMed

Coelho, Marcelo Santos; Parker, Jeffrey M; Tawil, Peter Z

2016-06-01

The aim of this retrospective clinical study was to evaluate the location and treatment of second canals in mesiobuccal roots (MB2) of first and second maxillary molars in a predoctoral endodontic clinic by the graduating classes of 2008 to 2015. These results were compared to similar clinical studies. Included in the study were 368 root canal treatments performed by 310 third- and fourth-year dental students at one U.S. dental school. All cases were done under faculty supervision, and the students were instructed to use dental loupe magnification. Students' evaluation sheets were used to deteremine the total MB2 canals treated in first and second maxillary molars. The results showed that, overall, 72.55% of the teeth had an MB2 canal treated. The frequency was higher in first molars (75.91%) than in second molars (56.92%) (p<0.05). Third-year students were able to detect 39 MB2 canals in 57 maxillary molars (68.42%), while fourth-year students detected 228 MB2 canals in 311 teeth (73.31%) (p>0.05). Under proper supervision by experienced endodontists, these dental students were capable of treating MB2 canals in maxillary molars. The frequency of MB2 canals located and treated by dental students with the assistance of experienced professionals was higher in first than in second molars. No significant difference was found between third- and fourth-year students. The incidence of MB2 canals located and treated in this study was found to be similar to that in other clinical studies.

Multiple Rapid Swallow Maneuver Enhances the Clinical Utility of High-Resolution Manometry in Patients Showing Ineffective Esophageal Motility

PubMed Central

Min, Yang Won; Shin, Inseub; Son, Hee Jung; Rhee, Poong-Lyul

2015-01-01

Abstract The clinical significance of ineffective esophageal motility (IEM) together with multiple rapid swallow (MRS) has not been yet evaluated in the Chicago Classification v3.0. This study evaluated the adjunctive role of MRS in IEM and determined the criteria of abnormal MRS to maximize the utility of IEM. We analyzed 186 patients showing IEM or normal esophageal motility (NEM), who underwent esophageal high-resolution impedance–manometry for esophageal symptoms. Two different criteria for abnormal MRS were applied to IEM subjects, resulting in 2 corresponding subgroups: IEM-A when distal contractile integral (DCI) ratio between an average wet swallows and MRS contraction was <1 and IEM-B when MRS contraction DCI was <450 mm Hg-s-cm. One IEM subject inadequately performed MRS. Among the remaining 52 IEM subjects, 18 (34.6%) were classified into IEM-A and 23 (44.2%) into IEM-B. IEM subjects showed less complete bolus transit (median 0.0%, interquartile range 0.0–20.0% vs 60.0%, 30.0–80.0; P < 0.001) resulting in higher impaired bolus transit than NEM subjects (98.1% vs 66.9%, P = 0.001). IEM-B subjects showed additionally higher pathologic bolus exposure than NEM subjects (55.6% vs 29.3%, P = 0.001), whereas IEM-A subjects could not. Although IEM-B subjects had the highest prevalence of gastroesophageal reflux disease among the subjects groups, it did not reach statistical significance. In conclusion, IEM patients with abnormal MRS contraction have an increased risk of prolonged bolus clearance, poor bolus transit, and pathologic bolus exposure. IEM patients need to be assessed concerning whether MRS contraction DCI is <450 mm Hg-s-cm to segregate clinically relevant patients. PMID:26448010

Clinical and experimental study of TMJ distraction: preliminary results.

PubMed

Festa, F; Galluccio, G

1998-01-01

A physiotherapeutic approach, with manual maneuvers and/or distraction appliances, is indicated in the treatment of temporomandibular joint disorders (TMDs) to prevent the progressive fibrosis of the muscle fibers. In this article, the authors report preliminary results of experimental and clinical studies conducted to assess the real effect of distraction in temporomandibular joint disorders. The experimental invivo studies confirmed the structural alteration due to compression and distraction on the capsular and condylar tissues. Clinical cases are reported to show the increase of the intraarticular vertical dimension, with a forward and downward movement of the condyles in a more physiologic condition.

Empirical analysis shows reduced cost data collection may be an efficient method in economic clinical trials

PubMed Central

2012-01-01

Background Data collection for economic evaluation alongside clinical trials is burdensome and cost-intensive. Limiting both the frequency of data collection and recall periods can solve the problem. As a consequence, gaps in survey periods arise and must be filled appropriately. The aims of our study are to assess the validity of incomplete cost data collection and define suitable resource categories. Methods In the randomised KORINNA study, cost data from 234 elderly patients were collected quarterly over a 1-year period. Different strategies for incomplete data collection were compared with complete data collection. The sample size calculation was modified in response to elasticity of variance. Results Resource categories suitable for incomplete data collection were physiotherapy, ambulatory clinic in hospital, medication, consultations, outpatient nursing service and paid household help. Cost estimation from complete and incomplete data collection showed no difference when omitting information from one quarter. When omitting information from two quarters, costs were underestimated by 3.9% to 4.6%. With respect to the observed increased standard deviation, a larger sample size would be required, increased by 3%. Nevertheless, more time was saved than extra time would be required for additional patients. Conclusion Cost data can be collected efficiently by reducing the frequency of data collection. This can be achieved by incomplete data collection for shortened periods or complete data collection by extending recall windows. In our analysis, cost estimates per year for ambulatory healthcare and non-healthcare services in terms of three data collections was as valid and accurate as a four complete data collections. In contrast, data on hospitalisation, rehabilitation stays and care insurance benefits should be collected for the entire target period, using extended recall windows. When applying the method of incomplete data collection, sample size calculation has

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

PubMed

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

2017-10-01

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

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).

Laserthermia on head and neck malignancies--experimental and clinical studies.

PubMed

Ohyama, M; Nobori, T; Moriyama, I; Furuta, S; Shima, T

1988-01-01

In recent years, remarkable progress has been made in thermotherapy. However, there is little information on localized laser hyperthermia (laserthermia) or on conventional hyperthermia technique applied to head and neck cancers. We have developed a ceramic probe to insert into tumor tissue and irradiate the Nd:YAG laser omnidirectionally. This probe can heat a spherical range of 1.5 cm to 43 degrees C. This paper concerns experimental and clinical studies on the effectiveness of laserthermia using our technique in the tumor of head and neck regions. The results obtained were as follows: histological findings and biochemical studies of arachidonic acid metabolites on normal rabbit tongue after laserthermia showed very slight effect and relatively short duration of the concomitant inflammation. The combination of laserthermia and CDDP chemotherapy was found to give a much better cytocidal effect on the tumor tissue in nude mice implanted with human thyroid cancer cells. In a clinical study on 21 cases with head and neck cancers, four cases showed complete and 13 cases showed partial remission after combined treatments of laserthermia and radiochemotherapy. Both basic experimental and clinical results have indicated a role for laserthermia in the treatment of head and neck cancer. Possible uses include the treatment of early cancer as well as advanced or recurrent cancer, where its therapeutic effect may be increased by combination with radiotherapy or chemotherapy.

Regional and National Grid Integration Studies Consistently Show Higher

Science.gov Websites

Levels of Renewables Are Possible | Energy Analysis | NREL Regional and National Grid Integration Studies Consistently Show Higher Levels of Renewables Are Possible Regional and National Grid Integration Studies Consistently Show Higher Levels of Renewables Are Possible Analysis Insights: April 2015

Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

PubMed

Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

2014-01-01

An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

PubMed

Takahashi, K; Sengoku, S; Kimura, H

2011-02-01

A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows.

PubMed

Ebert, Fanny; Staufenbiel, Rudolf; Simons, Julia; Pieper, Laura

2017-06-01

Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms. Copyright © 2017 American Dairy Science Association. Published by

EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA): a protocol of a European multicentre observational study.

PubMed

Gutiérrez-Gutiérrez, Belén; Sojo-Dorado, Jesús; Bravo-Ferrer, José; Cuperus, Nienke; de Kraker, Marlieke; Kostyanev, Tomislav; Raka, Lul; Daikos, George; Feifel, Jan; Folgori, Laura; Pascual, Alvaro; Goossens, Herman; O'Brien, Seamus; Bonten, Marc J M; Rodríguez-Baño, Jesús

2017-04-03

The rapid worldwide spread of carbapenem-resistant Enterobacteriaceae (CRE) constitutes a major challenge. The aim of the EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA), which is part of the Innovative Medicines Initiative Joint Undertaking (IMI JU) funded COMBACTE-CARE project, is to investigate risk factors for and outcome determinants of CRE infections to inform randomised clinical trial designs and to provide a historical cohort that could eventually be used for future comparisons with new drugs targeting CRE. A multicentre (50 sites), multinational (11 European countries), analytical observational project was designed, comprising 3 studies. The aims of study 1 (a prospective cohort study) include characterising the features, clinical management and outcomes of hospitalised patients with intra-abdominal infection, pneumonia, complicated urinary tract infections and bloodstream infections caused by CRE (202 patients in each group). The main outcomes will be 30-day all-cause mortality and clinical response. Study 2 (a nested case-control study) will identify the risk factors for target infections caused by CRE; 248 selected patients from study 1 will be matched with patients with carbapenem-susceptible Enterobacteriaceae (1:1) and with hospitalised patients (1:3) and will provide a historical cohort of patients with CRE infections. Study 3 (a matched cohort study) will follow patients in study 2 in order to assess mortality, length of stay and hospital costs associated with CRE. All patients will be followed for 30 days. Different, up-to-date statistical methods will be applied to come to unbiased estimates for all 3 studies. Before-study sites will be initiated, approval will be sought from appropriate regulatory agencies and local Ethics Committees of Research or Institutional Review Boards (IRBs) to conduct the study in accordance with regulatory requirements. This is an observational study and therefore no

Expert views on clinical supervision: a study based on interviews.

PubMed

Severinsson, E I; Borgenhammar, E V

1997-05-01

Clinical supervision is a didactic process of the purpose of human development and maturity. The aim of this study is to analyse views on clinical supervision held by a number of experts, and to reflect on the effects and value of clinical supervision in relation to public health. Data were collected by interviews and analysed in accordance with the grounded theory construction model. The results showed that clinical supervision is an integration process guiding a person from 'novice to expert' by establishing a relationship of trust between supervisor and supervisee. This study indicates that implementation of systematic clinical supervision may positively affect quality of care, and patients' recovery, create improved feeling of confidence in one's work, and prevent burnout among staff. The negative aspects, as reported, were the possibility of high 'opportunity costs', e.g. the time loss for patient care by those participating in organized systematic supervision. On the other hand, clinical supervision contributes towards more efficient use of resources and hence avoids unnecessary costs. However, neither of these aspects were further elaborated on by the experts but clearly indicate an important field for further research.

A pilot study in non-human primates shows no adverse response to intravenous injection of quantum dots.

PubMed

Ye, Ling; Yong, Ken-Tye; Liu, Liwei; Roy, Indrajit; Hu, Rui; Zhu, Jing; Cai, Hongxing; Law, Wing-Cheung; Liu, Jianwei; Wang, Kai; Liu, Jing; Liu, Yaqian; Hu, Yazhuo; Zhang, Xihe; Swihart, Mark T; Prasad, Paras N

2012-05-20

Quantum dots have been used in biomedical research for imaging, diagnostics and sensing purposes. However, concerns over the cytotoxicity of their heavy metal constituents and conflicting results from in vitro and small animal toxicity studies have limited their translation towards clinical applications. Here, we show in a pilot study that rhesus macaques injected with phospholipid micelle-encapsulated CdSe/CdS/ZnS quantum dots do not exhibit evidence of toxicity. Blood and biochemical markers remained within normal ranges following treatment, and histology of major organs after 90 days showed no abnormalities. Our results show that acute toxicity of these quantum dots in vivo can be minimal. However, chemical analysis revealed that most of the initial dose of cadmium remained in the liver, spleen and kidneys after 90 days. This means that the breakdown and clearance of quantum dots is quite slow, suggesting that longer-term studies will be required to determine the ultimate fate of these heavy metals and the impact of their persistence in primates.

Clinical application of antidepressant pharmacogenetics: considerations for the design of future studies.

PubMed

Fabbri, Chiara; Serretti, Alessandro

2018-06-12

A frustrating inertia has affected the development of clinical applications of antidepressant pharmacogenetics and personalized treatments of depression are still lacking 20 years after the first findings. Candidate gene studies provided replicated findings for some polymorphisms, but each of them shows at best a small effect on antidepressant efficacy and the cumulative effect of different polymorphisms is unclear. Further, no candidate was immune by at least some negative studies. These considerations give rise to some concerns about the clinical benefits of currently available pharmacogenetic tests since they are based on the results of candidate gene studies. Clinical guidelines in fact suggest that only polymorphisms that alter cytochrome 2D6 or 2C19 enzymatic activity probably provide useful clinical indications, while variants in genes involved in antidepressant pharmacodynamics have no recommended clinical applications. The present review discusses possible strategies to facilitate the identification of genetic biomarkers with clinical usefulness in guiding antidepressant treatments. These include analysis methods for the study of the polygenic/omnigenic nature of antidepressant response, the prioritization of polymorphisms on the basis of functional considerations, the incorporation of clinical-demographic predictors in pharmacogenetic studies (e.g. mixed polygenic and clinical risk scores), the application of methodological improvements to the design of future studies in order to maximize the comparability of results and improve power. Copyright © 2018. Published by Elsevier B.V.

Pedagogical strategies used in clinical medical education: an observational study

PubMed Central

2010-01-01

Background Clinical teaching is a complex learning situation influenced by the learning content, the setting and the participants' actions and interactions. Few empirical studies have been conducted in order to explore how clinical supervision is carried out in authentic situations. In this study we explore how clinical teaching is carried out in a clinical environment with medical students. Methods Following an ethnographic approach looking for meaning patterns, similarities and differences in how clinical teachers manage clinical teaching; non-participant observations and informal interviews were conducted during a four month period 2004-2005. The setting was at a teaching hospital in Sweden. The participants were clinical teachers and their 4th year medical students taking a course in surgery. The observations were guided by the aim of the study. Observational notes and notes from informal interviews were transcribed after each observation and all data material was analysed qualitatively. Results Seven pedagogical strategies were found to be applied, namely: 1) Questions and answers, 2) Lecturing, 3) Piloting, 4) Prompting, 5) Supplementing, 6) Demonstrating, and 7) Intervening. Conclusions This study contributes to previous research in describing a repertoire of pedagogical strategies used in clinical education. The findings showed that three superordinate qualitatively different ways of teaching could be identified that fit Ramsden's model. Each of these pedagogical strategies encompass different focus in teaching; either a focus on the teacher's knowledge and behaviour or the student's behaviour and understanding. We suggest that an increased awareness of the strategies in use will increase clinical teachers' teaching skills and the consequences they will have on the students' ability to learn. The pedagogical strategies need to be considered and scrutinized in further research in order to verify their impact on students' learning. PMID:20105340

Midwifery students' experiences of learning clinical skills in Iran: a qualitative study.

PubMed

Ahmadi, Golnoosh; Shahriari, Mohsen; Keyvanara, Mahmood; Kohan, Shahnaz

2018-03-09

A qualitative study was used. Midwifery students from three universities in Iran participated. The study used a convenience sample of eighteen students. Data for this study was collected using semi-structured interviews (N=12) and focus groups (N=6). Data were recorded on a digital audio recorder and then transcribed. The qualitative data were analyzed using a content analysis approach. Six broad themes emerged from the analysis: Limited opportunities to experience skills, difficulties with course plan gaps, need for creating a supportive clinical environment, learning drives, confusion between different methods, and stress in the clinical setting. Short verbatim quotations from the participants were presented to provide evidence for the interpretation of data. The findings of this study have provided a clear picture of the factors and mechanisms involved in learning clinical skills by midwifery students. This study showed that students had some difficulties and concerns during learning of clinical midwifery skills. The findings of this study suggest that midwifery educators conduct further studies to tackle these issues in clinical skills learning. The findings of this study are subject to some limitations which are discussed.

A Phase III Clinical Trial Showing Limited Efficacy of Autologous Mesenchymal Stem Cell Therapy for Spinal Cord Injury.

PubMed

Oh, Sun Kyu; Choi, Kyoung Hyo; Yoo, Jong Yoon; Kim, Dae Yul; Kim, Sang Joon; Jeon, Sang Ryong

2016-03-01

In our previous report, 3 of 10 patients with spinal cord injury who were injected with autologous mesenchymal stem cells (MSCs) showed motor improvement in the upper extremities and in activities of daily living. To report on the results of a phase III clinical trial of autologous MSCs therapy. Patients were selected based on the following criteria: chronic American Spinal Injury Association B status patients who had more than 12 months of cervical injury, and no neurological changes during the recent 3 months of vigorous rehabilitation. We injected 1.6 × 10 autologous MSCs into the intramedullary area at the injured level and 3.2 × 10 autologous MSCs into the subdural space. Outcome data were collected over 6 months regarding neurological examination, magnetic resonance imaging with diffusion tensor imaging, and electrophysiological analyses. Among the 16 patients, only 2 showed improvement in neurological status (unilateral right C8 segment from grade 1 to grade 3 in 1 patient and bilateral C6 from grade 3 to grade 4 and unilateral right C8 from grade 0 to grade 1 in 1 patient). Both patients with neurological improvement showed the appearance of continuity in the spinal cord tract by diffusion tensor imaging. There were no adverse effects associated with MSCs injection. Single MSCs application to intramedullary and intradural space is safe, but has a very weak therapeutic effect compared with multiple MSCs injection. Further clinical trials to enhance the effect of MSCs injection are necessary.

[A clinical study of endodontic flare-ups].

PubMed

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

1994-06-01

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

ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

PubMed

Turner, Leigh

2017-09-01

Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

Clinical Benefits of Rivastigmine in the Real World Dementia Clinics of the Okayama Rivastigmine Study (ORS).

PubMed

Matsuzono, Kosuke; Sato, Kota; Kono, Syoichiro; Hishikawa, Nozomi; Ohta, Yasuyuki; Yamashita, Toru; Deguchi, Kentaro; Nakano, Yumiko; Abe, Koji

2015-01-01

Alzheimer's disease (AD) is one of the most important diseases in an aging society, but the clinical effects of rivastigmine have not been fully examined in real world domestic clinics. We performed the "Okayama Rivastigmine Study (ORS)" to retrospectively analyze the clinical effects of rivastigmine (n = 75) or donepezil (n = 71) on AD patients with seven dementia assessment batteries at the baseline, 3, 6, and 12 months. In addition, we divided the rivastigmine group into two subgroups at the baseline: the mild behavioral and psychological symptoms of dementia (BPSD) group (Abe's BPSD score (ABS) <6) and the severe BPSD group (6≤ABS). In these two subgroups, baseline scores and changes were also retrospectively analyzed until 12 months. Rivastigmine significantly improved the Mini-Mental State Examination score at 3 months (*p <  0.05 versus baseline) and at 6 months (*p <  0.05), the Frontal Assessment Battery (FAB) at 6 months (*p <  0.05), and ABS at 3 months (**p <  0.01) while donepezil only stabilized the three cognitive scores. On the other hand, the Geriatric Depression Scale and the Apathy Scale were stable until 12 months in both groups. Baseline BPSD severity-dependent analysis showed a small improvement of FAB at 6 months in the mild BPSD subgroup (*p <  0.05) and a great improvement of ABS at 3 months in the severe BPSD subgroup (**p <  0.01) in the rivastigmine group. Our present study showed that rivastigmine improved both cognitive and affective functions at 3 and 6 months, and suggested an advantage at 3 and 6 months compared to donepezil in real world dementia clinics.

Clinical effectiveness of diode laser therapy as an adjunct to non-surgical periodontal treatment: a randomized clinical study.

PubMed

Dukić, Walter; Bago, Ivona; Aurer, Andrej; Roguljić, Marija

2013-08-01

The aim of this randomized clinical study is to evaluate the effect of a 980-nm diode laser as an adjunct to scaling and root planing (SRP) treatment. Thirty-five patients with chronic periodontitis were selected for the split-mouth clinical study. SRP was performed using a sonic device and hand instruments. Quadrants were equally divided between the right and left sides. Teeth were treated with SRP in two control quadrants (control groups [CG]), and the diode laser was used adjunctively with SRP in contralateral quadrants (laser groups [LG]). Diode laser therapy was applied to periodontal pockets on days 1, 3, and 7 after SRP. Baseline data, including approximal plaque index (API), bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL), were recorded before the treatment and 6 and 18 weeks after treatment. Changes in PD and CAL were analyzed separately for initially moderate (4 to 6 mm) and deep (7 to 10 mm) pockets. The results were similar for both groups in terms of API, BOP, PD in deep pockets, and CAL. The laser group showed only significant PD gain in moderate pockets during the baseline to 18-week (P <0.05) and 6- to 18- week (P <0.05) periods, whereas no difference was found between LG and CG in the remaining clinical parameters (P >0.05). The present study indicates that, compared to SRP alone, multiple adjunctive applications of a 980-nm diode laser with SRP showed PD improvements only in moderate periodontal pockets (4 to 6 mm).

A systematic review of clinical supervision evaluation studies in nursing.

PubMed

Cutcliffe, John R; Sloan, Graham; Bashaw, Marie

2018-02-15

According to the international, extant literature published during the last 20 years or so, clinical supervision (CS) in nursing is now a reasonably common phenomenon. Nevertheless, what appears to be noticeably 'thin on the ground' in this body of literature are empirical evaluations of CS, especially those pertaining to client outcomes. Accordingly, the authors undertook a systematic review of empirical evaluations of CS in nursing to determine the state of the science. Adopting the approach documented by Stroup et al. (JAMA, 283, 2000, 2008), the authors searched for reports of evaluation studies of CS in nursing - published during the years 1995 to 2015. Keywords for the search were 'clinical supervision', 'evaluation', 'efficacy', 'nursing', and combinations of these keywords. Electronic databases used were CINAHL, MEDLINE, PsychLIT, and the British Nursing Index. The research evidence from twenty-eight (28) studies reviewed is presented, outlining the main findings with an overview of each study presented. The following broad themes were identified and are each discussed in the study: narrative/anecdotal accounts of positive outcomes for clinical supervision, narrative/anecdotal accounts of negative outcomes for clinical supervision, empirical positive outcomes reported by supervisee, and empirical findings showing no effect by supervisee. © 2018 Australian College of Mental Health Nurses Inc.

Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis.

PubMed

Takeuchi, Tsutomu; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Kobayashi, Mariko; Shoji, Toshiharu; Togo, Osamu; Miyasaka, Nobuyuki; Koike, Takao

2016-07-01

To compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies. Data from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies. In both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]). Despite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile.

Conducting clinical post-conference in clinical teaching: a qualitative study.

PubMed

Hsu, Li-Ling

2007-08-01

The aim of this study was to explore nurse educators' perceptions regarding clinical postconferences. Additional aims included the exploration of interaction characteristics between students and faculty in clinical postconferences. Nursing students are challenged to think and learn in ways that will prepare them for practice in a complex health care environment. Clinical postconferences give students the opportunity to share knowledge gained through transformative learning and provide a forum for discussion and critical thinking. Faculty members must guide students as the latter participate in discussions, develop problem-solving skills and express feedings and attitudes in clinical conferences. The study used qualitative research methods, including participant observation and an open-ended questionnaire. Participant observers watched interaction activities between teachers and students in clinical postconferences. A total of 20 clinical postconferences, two conferences per teacher, were observed. The Non-Numerical Unstructured Data Indexing Searching and Theory-building qualitative software program was used in data analysis. Research findings indicated that, of the six taxonomy questions, lower-level questions (knowledge and comprehensive questions) were mostly asked by faculty members' postclinical conferences. The most frequently used guideline was task orientation, which is related to practice goals and was found in discussions of assignments, reading reports, discussions of clinical experiences, role plays, psychomotor skill practice, quizzes and student evaluations. It is an essential responsibility of nurse educators to employ postconferences to assist students in applying their knowledge in practical situations, in developing professional values and in enhancing their problem solving abilities.

Psychological functioning in adolescents referred to specialist gender identity clinics across Europe: a clinical comparison study between four clinics.

PubMed

de Graaf, Nastasja M; Cohen-Kettenis, Peggy T; Carmichael, Polly; de Vries, Annelou L C; Dhondt, Karlien; Laridaen, Jolien; Pauli, Dagmar; Ball, Juliane; Steensma, Thomas D

2018-07-01

Adolescents seeking professional help with their gender identity development often present with psychological difficulties. Existing literature on psychological functioning of gender diverse young people is limited and mostly bound to national chart reviews. This study examined the prevalence of psychological functioning and peer relationship problems in adolescents across four European specialist gender services (The Netherlands, Belgium, the UK, and Switzerland), using the Child Behavioural Checklist (CBCL) and the Youth Self-Report (YSR). Differences in psychological functioning and peer relationships were found in gender diverse adolescents across Europe. Overall, emotional and behavioural problems and peer relationship problems were most prevalent in adolescents from the UK, followed by Switzerland and Belgium. The least behavioural and emotional problems and peer relationship problems were reported by adolescents from The Netherlands. Across the four clinics, a similar pattern of gender differences was found. Birth-assigned girls showed more behavioural problems and externalising problems in the clinical range, as reported by their parents. According to self-report, internalising problems in the clinical range were more prevalent in adolescent birth-assigned boys. More research is needed to gain a better understanding of the difference in clinical presentations in gender diverse adolescents and to investigate what contextual factors that may contribute to this.

Gun Shows and Gun Violence: Fatally Flawed Study Yields Misleading Results

PubMed Central

Hemenway, David; Webster, Daniel; Pierce, Glenn; Braga, Anthony A.

2010-01-01

A widely publicized but unpublished study of the relationship between gun shows and gun violence is being cited in debates about the regulation of gun shows and gun commerce. We believe the study is fatally flawed. A working paper entitled “The Effect of Gun Shows on Gun-Related Deaths: Evidence from California and Texas” outlined this study, which found no association between gun shows and gun-related deaths. We believe the study reflects a limited understanding of gun shows and gun markets and is not statistically powered to detect even an implausibly large effect of gun shows on gun violence. In addition, the research contains serious ascertainment and classification errors, produces results that are sensitive to minor specification changes in key variables and in some cases have no face validity, and is contradicted by 1 of its own authors’ prior research. The study should not be used as evidence in formulating gun policy. PMID:20724672

Gun shows and gun violence: fatally flawed study yields misleading results.

PubMed

Wintemute, Garen J; Hemenway, David; Webster, Daniel; Pierce, Glenn; Braga, Anthony A

2010-10-01

A widely publicized but unpublished study of the relationship between gun shows and gun violence is being cited in debates about the regulation of gun shows and gun commerce. We believe the study is fatally flawed. A working paper entitled "The Effect of Gun Shows on Gun-Related Deaths: Evidence from California and Texas" outlined this study, which found no association between gun shows and gun-related deaths. We believe the study reflects a limited understanding of gun shows and gun markets and is not statistically powered to detect even an implausibly large effect of gun shows on gun violence. In addition, the research contains serious ascertainment and classification errors, produces results that are sensitive to minor specification changes in key variables and in some cases have no face validity, and is contradicted by 1 of its own authors' prior research. The study should not be used as evidence in formulating gun policy.

Embedding clinical interventions into observational studies

PubMed Central

Newman, Anne B.; Avilés-Santa, M. Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm. James; Krucoff, Mitchell; Kuller, Lewis H.; Lewis, Cora E.; Robinson, Jennifer G.; Taylor, Herman; Treviño, Roberto P.; Weintraub, William

2017-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

Registered nurses' clinical reasoning skills and reasoning process: A think-aloud study.

PubMed

Lee, JuHee; Lee, Young Joo; Bae, JuYeon; Seo, Minjeong

2016-11-01

As complex chronic diseases are increasing, nurses' prompt and accurate clinical reasoning skills are essential. However, little is known about the reasoning skills of registered nurses. This study aimed to determine how registered nurses use their clinical reasoning skills and to identify how the reasoning process proceeds in the complex clinical situation of hospital setting. A qualitative exploratory design was used with a think-aloud method. A total of 13 registered nurses (mean years of experience=11.4) participated in the study, solving an ill-structured clinical problem based on complex chronic patients cases in a hospital setting. Data were analyzed using deductive content analysis. Findings showed that the registered nurses used a variety of clinical reasoning skills. The most commonly used skill was 'checking accuracy and reliability.' The reasoning process of registered nurses covered assessment, analysis, diagnosis, planning/implementation, and evaluation phase. It is critical that registered nurses apply appropriate clinical reasoning skills in complex clinical practice. The main focus of registered nurses' reasoning in this study was assessing a patient's health problem, and their reasoning process was cyclic, rather than linear. There is a need for educational strategy development to enhance registered nurses' competency in determining appropriate interventions in a timely and accurate fashion. Copyright © 2016 Elsevier Ltd. All rights reserved.

Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis

PubMed Central

Takeuchi, Tsutomu; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Kobayashi, Mariko; Shoji, Toshiharu; Togo, Osamu; Miyasaka, Nobuyuki; Koike, Takao

2016-01-01

Abstract Objectives: To compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies. Methods: Data from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies. Results: In both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]). Conclusions: Despite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile. PMID:26472043

Embedding clinical interventions into observational studies.

PubMed

Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

2016-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. Copyright © 2015. Published by Elsevier Inc.

The wish to hasten death: a review of clinical studies.

PubMed

Monforte-Royo, Cristina; Villavicencio-Chávez, Christian; Tomás-Sábado, Joaquín; Balaguer, Albert

2011-08-01

It is common for patients who are faced with physical or psychological suffering, particularly those in the advanced stages of a disease, to have some kind of wish to hasten death (WTHD). This paper reviews and summarises the current state of knowledge about the WTHD among people with end-stage disease, doing so from a clinical perspective and on the basis of published clinical research. Studies were identified through a search strategy applied to the main scientific databases. Clinical studies show that the WTHD has a multi-factor aetiology. The literature review suggests-perhaps in line with better management of physical pain-that psychological and spiritual aspects, including social factors, are the most important cause of such a wish. One of the difficulties facing clinical research is the lack of terminological and conceptual precision in defining the construct. Indeed, studies frequently blur the distinction between a generic wish to die, a WTDH (whether sporadic or persistent over time), the explicit expression of a wish to die, and a request for euthanasia or physician-assisted suicide. A notable contribution to knowledge in this field has been made by scales designed to evaluate the WTHD, although the problems of conceptual definition may once again limit the conclusions, which can be drawn from the results. Studies using qualitative methodology have also provided new information that can help in understanding such wishes. Further clinical research is needed to provide a complete understanding of this phenomenon and to foster the development of suitable care plans. Copyright © 2010 John Wiley & Sons, Ltd.

Relapse after Oral Terbinafine Therapy in Dermatophytosis: A Clinical and Mycological Study.

PubMed

Majid, Imran; Sheikh, Gousia; Kanth, Farhath; Hakak, Rubeena

2016-01-01

The incidence of recurrent tinea infections after oral terbinafine therapy is on the rise. This study aims to identify the appearance of incomplete cure and relapse after 2-week oral terbinafine therapy in tinea corporis and/or tinea cruris. A total of 100 consecutive patients clinically and mycologically diagnosed to have tinea corporis and/or tinea cruris were included in the study. The enrolled patients were administered oral terbinafine 250 mg once daily for 2 weeks. All clinically cured patients were then followed up for 12 weeks to look for any relapse/cure. The common dermatophytes grown on culture were Trichophyton rubrum and Trichophyton tonsurans in 55% and 20% patients, respectively. At the end of 2-week oral terbinafine therapy, 30% patients showed a persistent disease on clinical examination while 35% patients showed a persistent positive fungal culture (persisters) at this time. These culture positive patients included all the clinically positive cases. Rest of the patients (65/100) demonstrated both clinical and mycological cure at this time (cured). Over the 12-week follow-up, clinical relapse was seen in 22 more patients (relapse) among those who had shown clinical and mycological cure at the end of terbinafine therapy. Thus, only 43% patients could achieve a long-term clinical and mycological cure after 2 weeks of oral terbinafine treatment. Majority of the relapses (16/22) were seen after 8 weeks of completion of treatment. There was no statistically significant difference in the body surface area involvement or the causative organism involved between the cured, persister, or relapse groups. Incomplete mycological cure as well as relapse is very common after standard (2-week) terbinafine therapy in our patients of tinea cruris/corporis.

Relationship between adherence to study and clinic visits in systemic lupus erythematosus patients: data from the LUMINA cohort.

PubMed

Uribe, A G; Ho, K T; Agee, B; McGwin, G; Fessler, B J; Bastian, H M; Reveille, J D; Alarcón, G S

2004-01-01

The aim of this study was to examine the relationship between nonadherence with study visits and with regularly scheduled clinic visits after adjusting for other patient and disease characteristics. One hundred and forty-one LUMINA patients with appointment data in the institutions' computerized systems (UAB and UTH) were studied. 'No shows' were assessed as the percentage of appointments not attended for either rheumatology, other clinics and LUMINA visits (from zero to 100%). Eighty-nine percent of the patients were women, 40% were Caucasians, 55% African-Americans and 5% Hispanics. 'No shows' to rheumatology were associated with non-Caucasian ethnicity, younger age, single marital status, lack of home ownership, 'no shows' to other clinics and to the LUMINA study, greater disease activity and to some disease manifestations (serositis, renal involvement, positive anti-dsDNA antibodies). In multivariable analyses, features predictive of rheumatology 'no shows' were lack of home ownership, 'no shows' to LUMINA study visits, renal involvement and serosal manifestations. Nonadherence with study visits and with regularly scheduled care at rheumatology clinics were associated. Other factors predictive of nonadherence to recommended care were lack of home ownership (a measurement of low socioeconomic status) and the presence of disease manifestations (i.e., renal or serosal involvement). These data should be considered when caring for patients with SLE.

RS3PE syndrome: a clinical and immunogenetical study.

PubMed

Queiro, Rubén

2004-03-01

This study analyses the clinical, radiological, evolutive, and immunogenetical characteristics of a series of patients diagnosed with remitting seronegative symmetrical synovitis with pitting edema (RS3PE) syndrome. Reviewed were the clinical charts and human leukocyte antigen (HLA) profiles of all patients treated at a single teaching hospital fulfilling the features of this syndrome according to the definition of McCarty. Twelve cases were detected in ten men and two women aged from 62 to 85 years. Rheumatoid factor was negative in all cases, and antinuclear antibodies (ANA) were positive in two. All patients achieved complete resolution of their condition within 1 year with glucocorticoid (GC) use. Two relapsed after remission but responded again to low doses of GC. Four patients showed clinical and electrodiagnostic studies consistent with carpal tunnel syndrome. No specific HLA association could be found in this report. To date, none of these patients has developed definite rheumatic diseases, infections, or malignant diseases. Although the real nature of the syndrome is still a matter of debate, at least in our context, RS3PE remains a definite condition with an excellent prognosis.

Poikiloderma of Civatte: a clinical and epidemiological study.

PubMed

Katoulis, A C; Stavrianeas, N G; Georgala, S; Bozi, E; Kalogeromitros, D; Koumantaki, E; Katsambas, A D

2005-07-01

Although a common dermatosis, idiopathic poikiloderma of the face and neck has not been studied in depth for decades. To reassess the clinical and epidemiological characteristics of poikiloderma of Civatte (PC). Fifty consecutive patients with PC. Evaluation included history taking and physical examination. Epidemiological and clinical parameters were recorded and analysed. The literature from 1923 until today, was reviewed thoroughly. The frequency of PC among dermatologic patients was estimated to be 1.4%. There were 34 females (68%) and 16 males in the present study. The mean age at diagnosis was 47.8 years for females and 61.7 years for males. The majority (88%) had skin phototype II or III. Among females, 26 were at their peri-menopausal stage, including three cases of iatrogenic menopause. Four patients reported that other blood-related family members also had PC. The v and the sides of the neck and the upper chest were most often affected in a symmetric distribution. The face (preauricular and parotid region) was involved in 19 patients (38%). The erythemato-telangiectatic clinical type predominated (58%), followed by the mixed (22%) and the pigmented type (20%). Almost half of the patients (46%) were symptomatic (itching, burning and 'flushing'). The mean duration from onset to diagnosis was 6.2 years according to the patients' report. The course was usually slowly progressive (82%) and irreversible. PC shows characteristic features, supporting the theory that it represents a distinct entity. It is rather common in Greece. Although menopausal women predominated in our cohort, men were not uncommonly affected and were diagnosed at an older age. Based on the predominating clinical feature, PC can be classified into three clinical forms. Symmetry and sparing of the anatomically shaded areas of the neck are highly characteristic for PC. Face involvement was not as common and as severe as it had been considered in the past. Recognition of clinical type is

Self-induced vomiting and dental erosion--a clinical study.

PubMed

Uhlen, Marte-Mari; Tveit, Anne Bjørg; Stenhagen, Kjersti Refsholt; Mulic, Aida

2014-07-29

In individuals suffering from eating disorders (ED) characterized by vomiting (e.g. bulimia nervosa), the gastric juice regularly reaches the oral cavity, causing a possible risk of dental erosion. This study aimed to assess the occurrence, distribution and severity of dental erosions in a group of Norwegian patients experiencing self-induced vomiting (SIV). The individuals included in the study were all undergoing treatment at clinics for eating disorders and were referred to a university dental clinic for examinations. One calibrated clinician registered erosions using the Visual Erosion Dental Examination (VEDE) system. Of 72 referred patients, 66 (63 females and three males, mean age 27.7 years) were or had been experiencing SIV (mean duration 10.6 years; range: 3 - 32 years), and were therefore included in the study. Dental erosions were found in 46 individuals (69.7%), 19 had enamel lesions only, while 27 had both enamel and dentine lesions. Ten or more teeth were affected in 26.1% of those with erosions, and 9% had ≥10 teeth with dentine lesions. Of the erosions, 41.6% were found on palatal/lingual surfaces, 36.6% on occlusal surfaces and 21.8% on buccal surfaces. Dentine lesions were most often found on lower first molars, while upper central incisors showed enamel lesions most frequently. The majority of the erosive lesions (48.6%) were found in those with the longest illness period, and 71.7% of the lesions extending into dentine were also found in this group. However, despite suffering from SIV for up to 32 years, 30.3% of the individuals showed no lesions. Dental erosion commonly affects individuals with ED experiencing SIV, and is more often found on the palatal/lingual surfaces than on the buccal in these individuals, confirming a common clinical assumption.

[ilin Pills for oligoasthenospermia: Advances in clinical studies].

PubMed

Zhang, Kai-Shu; Fu, Long-Long; Shang, Xue-Jun; Gu, Yi-Qun

2017-10-01

Industrialization and environmental pollution are bringing more problems to human reproduction and increasing the prevalence of male infertility. Western medicine has shown its limitations in the management of male infertility, especially that of oligoasthenospermia. Traditional Chinese medicine (TCM), however, has long and rich experiences in the treatment of oligoasthenospermia, with a large variety of medicinal prescriptions based on the TCM theories, among which Qilin Pills shows a particularly significant therapeutic effect on oligoasthenospermia, especially when combined with Western medicine. At present, published studies on Qilin Pills are mainly in the stage of clinical observation, while basic researches and studies on its relevant mechanisms are rarely seen.

[A clinical study of PC-904 in pediatrics (author's transl)].

PubMed

Hori, M; Kono, S; Hashimoto, F

1978-07-01

A clinical study of PC-904 was performed in children. The results were as follows; 1) Serum levels of PC-904 after single administration of 20 mg/kg were studied in patients by one-shot intravenous injection or drip infusion for 1 hour or 2 hours. The results obtained in this fundamental study led to the suggestion that the proper dosage in bacterial infections would be 50 approximately 100 mg/kg intravenously in 3 approximately 4 divided doses daily. 2) A clinical study of PC-904 was performed in 16 patients including acute pharyngitis and bronchitis (3 cases), acute bronchopneumonia (3 cases), pertussis pneumonia (1 case), lymphadenitis purulenta (2 cases), acute bronchopneumonia (3 cases), pertussis pneumonia (1 case), lymphadenitis purulenta (2 cases), abscess with chronic granuloma (2 cases) and urinary tract infection (5 cases). About 50 approximately 100 mg/kg of PC-904 were administered in 3 approximately 4 divided doses daily by one-shot intravenous injection. The clinical effects of 2 cases out of 16 were impossible to be evaluated, and thses cases were excluded from the clinical evaluation. Ten cases out of 14 showed excellent or good responses (efficacy rate: 71.4%). 3) The bacteriological examinations were performed and the causative or isolated organisms were determined in 11 cases. The responses were "disappeared" in 6 cases, "decreased" in 2 cases and "not disappeared" in 3 cases. 4) No side effects were observed. Abnormalities of laboratory findings were not also noticed.

Taking the Show on the Road in Holding Academic Classes in Community Agencies: Exploratory Study Findings

ERIC Educational Resources Information Center

Katz, Ellen; Serbinski, Sarah; Mishna, Faye

2017-01-01

Social work educators often teach students clinical knowledge within a university classroom, whereas students tend to learn clinical practice through their practicum experiences. This article describes data from a cross-sectional, mixed-method study on one way to effectively bridge the gap between teaching clinical knowledge and practice to…

Study Shows Philippine Power System Can Achieve 30% and 50% Renewable

Science.gov Websites

Energy by 2030 | News | NREL Study Shows Philippine Power System Can Achieve 30% and 50 % Renewable Energy by 2030 Study Shows Philippine Power System Can Achieve 30% and 50% Renewable Energy by of the Philippines (NGCP), and the Philippine Electricity Market Association produced the study

A CLINICAL STUDY OF 276 PATIENTS DIAGNOSED AS SUFFERING FROM HYSTERIA

PubMed Central

Subramanian, Deepa; Subramanian, K.; Devaky, M. N.; Verghese, Abraham

1980-01-01

SUMMARY A clinical study of 276 patients diagnosed as Hysteria in the Department of Psychiatry, Unit-2, Christian Medical College, Vellore, during the period of 1970—1974 is described. This group of 276 patients formed 10.81% of the total new consultations during this period. 61.2% of these were females. The peak age of onset was 10-20 years. The majority were married. 75% of them had conversion symptoms, 20.3% had dissociative states, and 4.7% had both features. 52.5% showed possible precipitating factors. 66.0% h i d features of extraversion in their personality make up. 14.1% showed evidence of parental deprivation. There was over-representation of the early born. Somatic symptoms (aches and pains) was the most common mode of presentation. The other common clinical manifestations were fainting attacks, “fits”, vomiting, involuntary movements and paralysis of limbs. The immediate follow up showed that 11 patients recovered, 120 improved, 3 were unchanged and 1 patient became worse. Only 93 patients could be contacted for the final follow up. Among these, 28 recovered completely; 50 were improved; 2 became worse and 2 died. It is emphasized that Hysteria continues to remain a clinical entity. PMID:22058441

Nursing Challenges in Motivating Nursing Students through Clinical Education: A Grounded Theory Study.

PubMed

Nasrin, Hanifi; Soroor, Parvizy; Soodabeh, Joolaee

2012-01-01

Nurses are the first role models for students in clinical settings. They can have a significant role on students' motivation. The purpose of this study was to explore the understanding of nursing students and instructors concerning the role of nurses in motivating nursing students through clinical education. The sampling was first started purposefully and continued with theoretical sampling. The study collected qualitative data through semistructured and interactive interviews with 16 nursing students and 4 nursing instructors. All interviews were recorded, transcribed, and analyzed using grounded theory approach. One important pattern emerged in this study was the "concerns of becoming a nurse," which itself consisted of three categories: "nurses clinical competency," "nurses as full-scale mirror of the future," and "Monitoring and modeling through clinical education" (as the core variable). The findings showed that the nurses' manners of performance as well as the profession's prospect have a fundamental role in the process of formation of motivation through clinical education. Students find an insight into the nursing profession by substituting themselves in the place of a nurse, and as result, are or are not motivated towards the clinical education.

Experimental Lung Cancer Drug Shows Early Promise | Poster

Cancer.gov

By Frank Blanchard, Staff Writer A first-of-its-kind drug is showing early promise in attacking certain lung cancers that are hard to treat because they build up resistance to conventional chemotherapy. The drug, CO-1686, performed well in a preclinical study involving xenograft and transgenic mice, as reported in the journal Cancer Discovery. It is now being evaluated for safety and efficacy in Phase I and II clinical trials.

[Clinical studies on flomoxef in acute tonsillitis].

PubMed

Tomiyama, M

1994-09-01

To objectively evaluate the clinical efficacy and safety in acute tonsillitis, flomoxef (FMOX) was examined for the distribution of sensitivity of clinical strains to it and for its clinical usefulness. 1. The 80% minimum inhibitory concentration of 11 clinical strains of Gram-positive bacteria, 6 of Gram-negative bacteria and 5 of anaerobic bacteria was 0.39 microgram/ml. FMOX showed the strongest, most comprehensive antibacterial action among the drugs tested. 2. Thirty patients received FMOX. Clinical effectiveness was evaluated in 28 patients, and clinical usefulness and safety in 30. 3. The clinical efficacy rate ('excellent' and 'good') was 75% (21/28). 4. As for bacteriological response, bacterial elimination rates were 67% for Gram-positive bacteria, 100% for Gram-negative bacteria, 100% for anaerobic bacteria and 100% for mixed infections. 5. Side effects occurred in 2 (6%) patients: drug eruption and diarrhea in 1 patient each. These symptoms improved rapidly after discontinuation of the drug. 6. Although abnormal clinical test results were found in 7 (23%) patients, i.e., increases in GOT and GPT in 2, in GPT in 4 and in BUN in 1, they were transient. 7. The usefulness of FMOX was assessed in light of its efficacy and safety. It was highly satisfactory in 14 patients, satisfactory in 11, relatively satisfactory in 1, unsatisfactory in 2 and highly unsatisfactory in 2, and rate of usefulness was 83%. FMOX is considered to be highly useful for the treatment of severe acute tonsillitis.

An evaluative study of clinical preceptorship.

PubMed

Kaviani, N; Stillwell, Y

2000-04-01

Clinical preceptorships, in collaboration between clinical agencies and educational institutions have been documented as an effective and innovative means of facilitating student learning, providing advantages for both the clinical and educational settings. A preceptorship programme of 100 hours duration was developed and delivered by the nurse education institute, in consultation with a health care organization. The objectives of the preceptorship programme were to help registered nurses, in partnership with clinical nurse educators, to effectively integrate, support and assist the development of clinical competence in the undergraduate nursing student. Following the implementation of the preceptorship programme a research study was conducted to evaluate programme effectiveness. The purpose of the study was to examine preceptors, preceptees, and nurse managers' preceptions of the preceptor role and factors which influenced the performance of preceptors. The methods used in this study included those commonly found in evaluation research. That is, participants were drawn from those who were involved, either directly or indirectly, in the preceptorship programme, namely preceptors, preceptees and nurse managers. Using focus groups, they were each asked to identify the outcomes of the programme in practice. Study findings highlighted the importance of formal preceptor preparation, which was shown to enhance teaching and learning opportunities for student preceptees, personal and professional development of the preceptors, and the promotion of positive partnerships between nurse educators and nurse practitioners. The need for formal recognition of the preceptor role in practice, particularly in relation to the provision of adequate time and resources, emerged from the study. The research findings enabled the development of an evaluative model of preceptorship, which highlights the intrinsic and extrinsic factors impacting on the preceptor role.

Three-year clinical evaluation of two ceramic crown systems: a preliminary study.

PubMed

Etman, Maged K; Woolford, M J

2010-02-01

The clinical performance and failure mechanisms of recently introduced ceramic crown systems used to restore posterior teeth have not been adequately examined. The purpose of this prospective clinical study was to evaluate and compare the clinical performance of 2 new ceramic crown systems with that of metal ceramic crowns using modified United States Public Health Services (USPHS) criteria. Ninety posterior teeth requiring crown restorations in 48 patients were randomized into 3 equal groups (n=30) for which different crown systems were used: an experimental hot-pressed glass ceramic based on a modified lithium disilicate ceramic (IPS e.max Press), an alumina-coping-based ceramic (Procera AllCeram), and a metal ceramic (Simidur S 2 veneered with IPS Classic Porcelain). The crowns were assessed over 3 years using the modified USPHS criteria. Crowns that developed visible cracks were sectioned and removed, and the surfaces were analyzed using a scanning electron microscope (SEM). The data were analyzed using the Kruskal-Wallis nonparametric statistical test, followed by the Mann-Whitney test with Bonferroni correction (alpha=.05). USPHS evaluation showed that the IPS e.max Press and metal ceramic crowns experienced fewer clinical changes than Procera AllCeram. Visible roughness, wear, and deformity were noticed in occlusal contact areas of Procera AllCeram crowns. SEM images showed well defined wear facets in both ceramic crown systems. Kruskal-Wallis tests showed a significant difference (P<.05) in Alpha scores among the 3 crown systems. Mann-Whitney tests showed significant differences among groups. IPS e.max Press crowns demonstrated clinical behavior comparable to Procera AllCeram and metal ceramic crowns, but the wear resistance of this crown type was superior to the Procera AllCeram crowns, according to modified USPHS criteria.

Study by NOAA and Partners Shows Some Gulf Dolphins Severely Ill | NOAA

Science.gov Websites

Publications Press Releases Story Archive Home Study by NOAA and Partners Shows Some Gulf Dolphins Severely Ill Study by NOAA and Partners Shows Some Gulf Dolphins Severely Ill Aug 2011: Veterinarians collect samples of 2011, preliminary results show that many of the dolphins in the study are underweight, anemic

Clinical utility of FDG PET/CT in acute complicated pyelonephritis-results from an observational study.

PubMed

Wan, Chih-Hsing; Tseng, Jing-Ren; Lee, Ming-Hsun; Yang, Lan-Yan; Yen, Tzu-Chen

2018-03-01

Acute complicated pyelonephritis (ACP) is an upper urinary tract infection associated with coexisting urinary tract abnormalities or medical conditions that could predispose to serious outcomes or treatment failures. Although CT and magnetic resonance imaging (MRI) are frequently used in patients with ACP, the clinical value of 18 F-fluorodeoxyglucose positron emission tomography and computed tomography (FDG PET/CT) has not been systematically investigated. This single-center retrospective study was designed to evaluate the potential usefulness of FDG PET/CT in patients with ACP. Thirty-one adult patients with ACP who underwent FDG PET/CT were examined. FDG PET/CT imaging characteristics, including tracer uptake patterns, kidney volumes, and extrarenal imaging findings, were reviewed in combination with clinical data and conventional imaging results. Of the 31 patients, 19 (61%) showed focal FDG uptake. The remaining 12 study participants showed a diffuse FDG uptake pattern. After volumetric approximation, the affected kidneys were found to be significantly enlarged. Patients who showed a focal uptake pattern had a higher frequency of abscess formation requiring drainage. ACP patients showing diffuse tracer uptake patterns had a more benign clinical course. Seven patients had suspected extrarenal coinfections, and FDG PET/CT successfully confirmed the clinical suspicion in five cases. FDG PET/CT was as sensitive as CT in identifying the six patients (19%) who developed abscesses. Notably, FDG PET/CT findings caused a modification to the initial antibiotic regimen in nine patients (29%). FDG PET/CT may be clinically useful in the assessment of patients with ACP who have a progressive disease course.

Mirrors in early clinical photography (1862-1882): a descriptive study.

PubMed

Horgmo, Øystein H

2015-01-01

In the mid-nineteenth century, photographers used mirrors to document different views of a patient in the same image. The first clinical photographs were taken by portrait photographers. As conventions for clinical photography were not yet established, early clinical photographs resemble contemporary portraits. The use of mirrors in clinical photography probably originated from the portrait studios, as several renowned photographers employed mirrors in their studio portraits. Clinical photographs taken for the US Army Medical Museum between 1862 and 1882 show different ways of employing this mirror technique.

Study on biofilm-forming properties of clinical isolates of Staphylococcus aureus.

PubMed

Taj, Yasmeen; Essa, Farhan; Aziz, Faisal; Kazmi, Shahana Urooj

2012-05-14

The purpose of this study was to observe the formation of biofilm, an important virulence factor, by isolates of Staphylococcus aureus (S. aureus) in Pakistan by different conventional methods and through electron microscopy. We screened 115 strains of S. aureus isolated from different clinical specimens by tube method (TM), air-liquid interface coverslip assay method, Congo red agar (CRA) method, and scanning electron microscopy (SEM). Out of 115 S. aureus isolates, 63 (54.78%) showed biofilm formation by tube method. Biofilm forming bacteria were further categorized as high producers (n = 23, 20%) and moderate producers (n = 40, 34.78%). TM coordinated well with the coverslip assay for strong biofilm-producing strains in 19 (16.5%) isolates. By coverslip method, weak producers were difficult to differentiate from biofilm negative isolates. Screening on CRA showed biofilm formation only in four (3.47%) strains. Scanning electron micrographs showed the biofilm-forming strains of S. aureus arranged in a matrix on the propylene surface and correlated well with the TM. Biofilm production is a marker of virulence for clinically relevant staphylococcal infections. It can be studied by various methods but screening on CRA is not recommended for investigation of biofilm formation in Staphylococcus aureus. Electron micrograph images correlate well with the biofilm production as observed by TM.

In utero exposure to valproic acid and autism--a current review of clinical and animal studies.

PubMed

Roullet, Florence I; Lai, Jonathan K Y; Foster, Jane A

2013-01-01

Valproic acid (VPA) is both an anti-convulsant and a mood stabilizer. Clinical studies over the past 40 years have shown that exposure to VPA in utero is associated with birth defects, cognitive deficits, and increased risk of autism. Two recent FDA warnings related to use of VPA in pregnancy emphasize the need to reevaluate its use clinically during child-bearing years. The emerging clinical evidence showing a link between VPA exposure and both cognitive function and risk of autism brings to the forefront the importance of understanding how VPA exposure influences neurodevelopment. In the past 10 years, animal studies have investigated anatomical, behavioral, molecular, and physiological outcomes related to in utero VPA exposure. Behavioral studies show that VPA exposure in both rats and mice leads to autistic-like behaviors in the offspring, including social behavior deficits, increased repetitive behaviors, and deficits in communication. Based on this work VPA maternal challenge in rodents has been proposed as an animal model to study autism. This model has both face and construct validity; however, like all animal models there are limitations to its translation to the clinical setting. Here we provide a review of clinical studies that examined pregnancy outcomes of VPA use as well as the related animal studies. Copyright © 2013 Elsevier Inc. All rights reserved.

Towards Data Value-Level Metadata for Clinical Studies.

PubMed

Zozus, Meredith Nahm; Bonner, Joseph

2017-01-01

While several standards for metadata describing clinical studies exist, comprehensive metadata to support traceability of data from clinical studies has not been articulated. We examine uses of metadata in clinical studies. We examine and enumerate seven sources of data value-level metadata in clinical studies inclusive of research designs across the spectrum of the National Institutes of Health definition of clinical research. The sources of metadata inform categorization in terms of metadata describing the origin of a data value, the definition of a data value, and operations to which the data value was subjected. The latter is further categorized into information about changes to a data value, movement of a data value, retrieval of a data value, and data quality checks, constraints or assessments to which the data value was subjected. The implications of tracking and managing data value-level metadata are explored.

[Nursing students' satisfaction and perception of their first clinical placement: observational study].

PubMed

Comparcini, Dania; Simonetti, Valentina; Tomietto, Marco; Galli, Francesco; Fiorani, Catia; Di Labio, Luisa; Cicolini, Giancarlo

2014-01-01

Clinical learning environments are defined as an interactive network of forces within the clinical context that influence students' learning outcomes. Nursing students' satisfaction could be strictly related to their learning outcomes. Aim. To analyze the first year nursing students' clinical learning experience and to identify the main determinants of students' satisfaction. The observational study was carried out in five Italian nursing degree courses. 420 students filled out the validated Italian version of the "Clinical Learning Environment and Supervision plus Nurse Teacher (CLES+T) scale" after the conclusion of their first clinical placement. The mean values of the main sub-dimensions of CLES+T varied from 4.02 (pedagogical atmosphere) to 3.30 (supervisory relationship). Students were mainly satisfied with their clinical placement, however the findings showed statistical significantly differences among the five nursing courses. The main determinants of the overall students' satisfaction are the nurse manager's leadership style and the integration between theoretical knowledge and everyday practice of nursing through the relationship among students, clinical tutors and nurse teacher. Our results may contribute to better understand nursing students' perception of their first clinical placement. However, further research are needed to evaluate which organizational factors and clinical training models may enhance the clinical learning experience.

Motives for participating in a clinical research trial: a pilot study in Brazil.

PubMed

Nappo, Solange A; Iafrate, Giovanna B; Sanchez, Zila M

2013-01-10

In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Mixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral understanding of the ICS is not clear.

Prospective clinical observational study evaluating gender-associated differences of preoperative pain intensity.

PubMed

Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning

2016-07-01

Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery.Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0-100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis.Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th-75th percentiles: 10-52) versus 21 (10-46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men.This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies.

Advances in clinical study of curcumin.

PubMed

Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

2013-01-01

Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

Clinical Laboratory Automation: A Case Study

PubMed Central

Archetti, Claudia; Montanelli, Alessandro; Finazzi, Dario; Caimi, Luigi; Garrafa, Emirena

2017-01-01

Background This paper presents a case study of an automated clinical laboratory in a large urban academic teaching hospital in the North of Italy, the Spedali Civili in Brescia, where four laboratories were merged in a unique laboratory through the introduction of laboratory automation. Materials and Methods The analysis compares the preautomation situation and the new setting from a cost perspective, by considering direct and indirect costs. It also presents an analysis of the turnaround time (TAT). The study considers equipment, staff and indirect costs. Results The introduction of automation led to a slight increase in equipment costs which is highly compensated by a remarkable decrease in staff costs. Consequently, total costs decreased by 12.55%. The analysis of the TAT shows an improvement of nonemergency exams while emergency exams are still validated within the maximum time imposed by the hospital. Conclusions The strategy adopted by the management, which was based on re-using the available equipment and staff when merging the pre-existing laboratories, has reached its goal: introducing automation while minimizing the costs. Significance for public health Automation is an emerging trend in modern clinical laboratories with a positive impact on service level to patients and on staff safety as shown by different studies. In fact, it allows process standardization which, in turn, decreases the frequency of outliers and errors. In addition, it induces faster processing times, thus improving the service level. On the other side, automation decreases the staff exposition to accidents strongly improving staff safety. In this study, we analyse a further potential benefit of automation, that is economic convenience. We study the case of the automated laboratory of one of the biggest hospital in Italy and compare the cost related to the pre and post automation situation. Introducing automation lead to a cost decrease without affecting the service level to patients

Registration practices for observational studies on ClinicalTrials.gov indicated low adherence.

PubMed

Boccia, Stefania; Rothman, Kenneth J; Panic, Nikola; Flacco, Maria Elena; Rosso, Annalisa; Pastorino, Roberta; Manzoli, Lamberto; La Vecchia, Carlo; Villari, Paolo; Boffetta, Paolo; Ricciardi, Walter; Ioannidis, John P A

2016-02-01

The study aims to assess the status of registration of observational studies. We identified studies on cancer research with prospective recruitment of participants that were registered from February 2000 to December 2011 in ClinicalTrials.gov. We recorded the dates of registration and start of recruitment, outcomes, and description of statistical method. We searched for publications corresponding to the registered studies through May 31, 2014. One thousand one hundred nine registered studies were eligible. Primary and secondary outcomes were reported in 809 (73.0%) and 464 (41.8%) of them. The date of registration preceded the month of the study start in 145 (13.8%) and coincided in 205 (19.5%). A total of 151 publications from 120 (10.8%) registered studies were identified. In 2 (33.3%) of the 6 publications where ClinicalTrials.gov reported that the study started recruitment after registration, and in 9 (50.0%) of 18 publications where ClinicalTrials.gov reported the same date for registration and start of recruitment, the articles showed that the study had actually started recruiting before registration. During the period reviewed, few observational studies have been registered. Registration usually occurred after the study started, and prespecification of outcomes and statistical analysis rarely occurred. Copyright © 2016 Elsevier Inc. All rights reserved.

Drug addicts seeking treatment after the Iranian Revolution: a clinic-based study.

PubMed

Dalvand, S; Agahi, C; Spencer, C

1984-09-01

A sample survey of 200 addicts attending the Rehabilitation Centre at Shiraz was conducted after the 1979 Iranian Revolution had disrupted both drug supply and addict treatment programmes. The study showed that clinics were, after the revolution, seeing a broader social range of addicts than before; and that action by the authorities was bringing many recently-addicted individuals to clinics. Heroin use predominated among those who were urban residents, whilst villagers were more likely to be opium users. The survey also sought the addicts' perceptions of the reasons for their initiation and addiction.

Study of cognitive functions in newly diagnosed cases of subclinical and clinical hypothyroidism.

PubMed

Sharma, Kirti; Behera, Joshil Kumar; Sood, Sushma; Rajput, Rajesh; Satpal; Praveen, Prashant

2014-01-01

Hypothyroidism is associated with significant neurocognitive deficits because hypothyroidism prevents the brain from adequately sustaining the energy consuming processes needed for neurotransmission, memory, and other higher brain functions. Hence, the study was done to assess the cognitive functions of newly diagnosed subclinical and clinical hypothyroid patients by evoked response potential P300. 75 patients each of newly diagnosed subclinical and clinical hypothyroid patients attending endocrinology clinic and 75 healthy age and sex matched euthyroid controls were considered for the study. P300 was recorded with Record Medicare System Polyrite, Chandigarh using auditory "oddball paradigm". The data was analyzed using ANOVA followed by post Tukey's test. Newly diagnosed clinical hypothyroid patients showed a significant increase in P300 latency compared to control (P < 0.05) and subclinical cases (P < 0.01) while there was no significant difference between the P300 latency of subclinical cases and control group. Also, there was no significant difference in P300 amplitude among the three groups. P300 latency in case of newly diagnosed hypothyroid clinical cases is significantly increased compared to newly diagnosed subclinical cases and control.

Self-induced vomiting and dental erosion – a clinical study

PubMed Central

2014-01-01

Background In individuals suffering from eating disorders (ED) characterized by vomiting (e.g. bulimia nervosa), the gastric juice regularly reaches the oral cavity, causing a possible risk of dental erosion. This study aimed to assess the occurrence, distribution and severity of dental erosions in a group of Norwegian patients experiencing self-induced vomiting (SIV). Methods The individuals included in the study were all undergoing treatment at clinics for eating disorders and were referred to a university dental clinic for examinations. One calibrated clinician registered erosions using the Visual Erosion Dental Examination (VEDE) system. Results Of 72 referred patients, 66 (63 females and three males, mean age 27.7 years) were or had been experiencing SIV (mean duration 10.6 years; range: 3 – 32 years), and were therefore included in the study. Dental erosions were found in 46 individuals (69.7%), 19 had enamel lesions only, while 27 had both enamel and dentine lesions. Ten or more teeth were affected in 26.1% of those with erosions, and 9% had ≥10 teeth with dentine lesions. Of the erosions, 41.6% were found on palatal/lingual surfaces, 36.6% on occlusal surfaces and 21.8% on buccal surfaces. Dentine lesions were most often found on lower first molars, while upper central incisors showed enamel lesions most frequently. The majority of the erosive lesions (48.6%) were found in those with the longest illness period, and 71.7% of the lesions extending into dentine were also found in this group. However, despite suffering from SIV for up to 32 years, 30.3% of the individuals showed no lesions. Conclusions Dental erosion commonly affects individuals with ED experiencing SIV, and is more often found on the palatal/lingual surfaces than on the buccal in these individuals, confirming a common clinical assumption. PMID:25069878

Clinical Laboratory Automation: A Case Study.

PubMed

Archetti, Claudia; Montanelli, Alessandro; Finazzi, Dario; Caimi, Luigi; Garrafa, Emirena

2017-04-13

This paper presents a case study of an automated clinical laboratory in a large urban academic teaching hospital in the North of Italy, the Spedali Civili in Brescia, where four laboratories were merged in a unique laboratory through the introduction of laboratory automation. The analysis compares the preautomation situation and the new setting from a cost perspective, by considering direct and indirect costs. It also presents an analysis of the turnaround time (TAT). The study considers equipment, staff and indirect costs. The introduction of automation led to a slight increase in equipment costs which is highly compensated by a remarkable decrease in staff costs. Consequently, total costs decreased by 12.55%. The analysis of the TAT shows an improvement of nonemergency exams while emergency exams are still validated within the maximum time imposed by the hospital. The strategy adopted by the management, which was based on re-using the available equipment and staff when merging the pre-existing laboratories, has reached its goal: introducing automation while minimizing the costs.

Facilitating Case Studies in Massage Therapy Clinical Education

PubMed Central

Baskwill, Amanda

2013-01-01

The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

Best practices for clinical pathology testing in carcinogenicity studies.

PubMed

Young, Jamie K; Hall, Robert L; O'Brien, Peter; Strauss, Volker; Vahle, John L

2011-02-01

The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.

A Cross‐Study Analysis Evaluating the Effects of Food on the Pharmacokinetics of Rivaroxaban in Clinical Studies

PubMed Central

Peters, Gary; Haskell, Lloyd; Patel, Purve; Nandy, Partha; Moore, Kenneth Todd

2017-01-01

Abstract US prescribing guidelines recommend that 15‐ and 20‐mg doses of rivaroxaban be administered with food for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for reduction in the risk of recurrence of DVT and PE. In addition, the US prescribing guidelines recommend these doses be administered with an evening meal to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). The purpose of this model‐based cross‐study comparison was to examine the impact of food, with regard to both meal timing and content, on the pharmacokinetics (PK) of rivaroxaban, using data collected during its clinical development. Results of this analysis showed that a PK model built from pooled data in the AF population (for whom rivaroxaban was administered with an evening meal) and in the DVT population (for whom rivaroxaban was administered with a morning meal) can describe both data sets well. Furthermore, the PK model built from data in the AF population alone can adequately predict the PK profile of the DVT population and vice versa. This cross‐study analysis also confirmed the findings from previous clinical pharmacology studies, which showed that meal content does not have a clinically relevant impact on the PK of rivaroxaban at 20 mg. Therefore, although the administration of rivaroxaban with food is necessary for maintaining high bioavailability, neither meal timing nor meal content appears to affect the PK of rivaroxaban. PMID:28679020

A Study of Clinically Related Open Source Software Projects

PubMed Central

Hogarth, Michael A.; Turner, Stuart

2005-01-01

Open source software development has recently gained significant interest due to several successful mainstream open source projects. This methodology has been proposed as being similarly viable and beneficial in the clinical application domain as well. However, the clinical software development venue differs significantly from the mainstream software venue. Existing clinical open source projects have not been well characterized nor formally studied so the ‘fit’ of open source in this domain is largely unknown. In order to better understand the open source movement in the clinical application domain, we undertook a study of existing open source clinical projects. In this study we sought to characterize and classify existing clinical open source projects and to determine metrics for their viability. This study revealed several findings which we believe could guide the healthcare community in its quest for successful open source clinical software projects. PMID:16779056

Italian multicentre study on microbial environmental contamination in dental clinics: a pilot study.

PubMed

Pasquarella, Cesira; Veronesi, Licia; Castiglia, Paolo; Liguori, Giorgio; Montagna, Maria Teresa; Napoli, Christian; Rizzetto, Rolando; Torre, Ida; Masia, Maria Dolores; Di Onofrio, Valeria; Colucci, Maria Eugenia; Tinteri, Carola; Tanzi, Marialuisa

2010-09-01

The dental practice is associated with a high risk of infections, both for patients and healthcare operators, and the environment may play an important role in the transmission of infectious diseases. A microbiological environmental investigation was carried out in six dental clinics as a pilot study for a larger multicentre study that will be performed by the Italian SItI (Society of Hygiene, Preventive Medicine and Public Health) working group "Hygiene in Dentistry". Microbial contamination of water, air and surfaces was assessed in each clinic during the five working days of the week, before and during treatments. Air and surfaces were also examined at the end of the daily activity. A wide variation was found in microbial environmental contamination, both within the participating clinics and relative to the different sampling times. Microbial water contamination in Dental Unit Water Systems (DUWS) reached values of up to 26x10(4)cfu/mL (colony forming units per millilitre). P. aeruginosa was found in 33% of the sampled DUWS and Legionella spp. in 50%. A significant decrease in the Total Viable Count (TVC) was recorded during the activity. Microbial air contamination showed the highest levels during dental treatments and tended to decrease at the end of the working activity (p<0.05). Microbial buildup on surfaces increased significantly during the working hours. As these findings point out, research on microbial environmental contamination and the related risk factors in dental clinics should be expanded and should also be based on larger collections of data, in order to provide the essential knowledge aimed at targeted preventive interventions. Copyright 2010 Elsevier B.V. All rights reserved.

Thyroid hyperfunctioning adenomas with and without Gsp/TSH receptor mutations show similar clinical features.

PubMed

Arturi, F; Capula, C; Chiefari, E; Filetti, S; Russo, D

1998-01-01

Activating mutations of Gs alpha protein (gsp) and TSH receptor (TSH-R) identified in autonomously hyperfunctioning thyroid adenomas have been proposed as the primary event responsible for this disease. Since mutations have not been detected in 100% (ranging from less than 10% to 90%) of the patients, we evaluated whether the presence of gsp and TSH-R mutations cause differences in the clinical and biochemical parameters of the affected patients. Fifteen consecutive patients (11 women and 4 men) with autonomously hyperfunctioning thyroid adenomas who underwent thyroidectomy, previously examined for the presence of gsp or TSH-R mutations, were investigated. In all of the patients we examined plasma free T3, free T4, TSH levels and ultrasound volume of the nodules. The patients with mutations in gsp or TSH-R were similar to the patients without mutations for clinical presentation, sex distribution and mean age. Furthermore, basal serum FT3, TSH and tumor volume in the patients with mutations were not significantly different from the group without mutations. Our preliminary data demonstrate that no significant differences are present in the two groups of patients examined, suggesting that factors other than gsp or TSH-R mutations play a role in the clinical presentation of the disease.

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study.

PubMed

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. This is an observational study with prospective recruitment (May 2014-May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses

Roles and Educational Effects of Clinical Case Studies in Home Medical Care.

PubMed

Ohsawa, Tomoji; Shimazoe, Takao

2017-01-01

Due to the progression of aging in Japan, pharmacists need to participate in home medical care. To enable pharmacists with no previous experience to participate in home medical care of patients with various diseases in the home environment, it is necessary to adopt an approach of training them in advance. It is thought useful for such clinical training to include patient case studies, which may facilitate the training of pharmacists for home medical care through simulated experience. "The working group to create home clinical cases for education" was launched by a group of university faculty, who have educational knowledge, and trained pharmacists who work with the patients at home. The home care cases were compiled by the university faculty members and the home care practice pharmacists. Working pharmacists and students at pharmaceutical college studied the same case studies of home medical care, and their self-evaluations were compared. They showed that the students rated themselves higher than the pharmacists. One of the reasons was the systematic education of the case studies. The clinical case studies are a good educational tool to promote home care medicine in pharmacies and university pharmaceutical colleges.

Assessing progression of clinical reasoning through virtual patients: An exploratory study.

PubMed

Forsberg, Elenita; Ziegert, Kristina; Hult, Håkan; Fors, Uno

2016-01-01

To avoid test-driven learning, there have been discussions regarding the use of more formative assessments in health care education to promote students' deep learning. Feedback is important in formative assessment, but many students ignore it; therefore, interventions should be introduced which stimulate them to reflect on the new knowledge. The aim for this study was to explore if Virtual Patient (VP)-based formative assessments, in connection with self-evaluations, had an impact on postgraduate pediatric nursing students' development of clinical reasoning abilities. Students' self-evaluations served as the basis for measuring progress. Data was analysed using deductive content analysis. The findings showed a clear progression of the clinical reasoning ability of the students. After the first assessment, the students described feelings of uncertainty and that their knowledge gaps were exposed. At the mid-course assessment the awareness of improved clinical reasoning was obvious and the students were more certain of knowing how to solve the VP cases. In the final assessment, self-efficacy was expressed. VP-based assessments, in connection with self-evaluations, early in the education resulted in a gain of students' own identification of the concept of clinical reasoning, awareness of what to focus on during clinical practice and visualised expected clinical competence. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation systems for clinical governance development: a comparative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

Leadership for learning: a literature study of leadership for learning in clinical practice.

PubMed

Allan, Helen T; Smith, Pamela A; Lorentzon, Maria

2008-07-01

To report a literature study of leadership for learning in clinical practice in the United Kingdom. Background Previous research in the United Kingdom showed that the ward sister was central to creating a positive learning environment for student nurses. Since the 1990s, the ward mentor has emerged as the key to student nurses' learning in the United Kingdom. A literature study of new leadership roles and their influence on student nurse learning (restricted to the United Kingdom) which includes an analysis of ten qualitative interviews with stakeholders in higher education in the United Kingdom undertaken as part of the literature study. Learning in clinical placements is led by practice teaching roles such as mentors, clinical practice facilitators and practice educators rather than new leadership roles. However, workforce changes in clinical placements has restricted the opportunities for trained nurses to role model caring activities for student nurses and university based lecturers are increasingly distant from clinical practice. Leadership for learning in clinical practice poses three unresolved questions for nurse managers, practitioners and educators - what is nursing, what should student nurses learn and from whom? Leadership for student nurse learning has passed to new learning and teaching roles with Trusts and away from nursing managers. This has implications for workforce planning and role modelling within the profession.

The no-show patient in the model family practice unit.

PubMed

Dervin, J V; Stone, D L; Beck, C H

1978-12-01

Appointment breaking by patients causes problems for the physician's office. Patients who neither keep nor cancel their appointments are often referred to as "no shows." Twenty variables were identified as potential predictors of no-show behavior. These predictors were applied to 291 Family Practice Center patients during a one-month study in April 1977. A discriminant function and multiple regression procedure were utilized ascertain the predictability of the selected variables. Predictive accuracy of the variables was 67.4 percent compared to the presently utilized constant predictor technique, which is 73 percent accurate. Modification of appointment schedules based upon utilization of the variables studies as predictors of show/no-show behavior does not appear to be an effective strategy in the Family Practice Center of the Community Hospital of Sonoma County, Santa Rosa, due to the high proportion of patients who do, in fact, show. In clinics with lower show rates, the technique may prove to be an effective strategy.

The Clinical Impression of Severity Index for Parkinson's Disease: international validation study.

PubMed

Martínez-Martín, Pablo; Rodríguez-Blázquez, Carmen; Forjaz, Maria João; de Pedro, Jesús

2009-01-30

This study sought to provide further information about the psychometric properties of the Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD), in a large, international, cross-culturally diverse sample. Six hundred and fourteen patients with PD participated in the study. Apart from the CISI-PD, assessments were based on Hoehn & Yahr (HY) staging, the Scales for Outcomes in PD-Motor (SCOPA-M), -Cognition (SCOPA-COG) and -Psychosocial (SCOPA-PS), the Cumulative Illness Rating Scale-Geriatrics, and the Hospital Anxiety and Depression Scale. The total CISI-PD score displayed no floor or ceiling effects. Internal consistency was 0.81, the test-retest intraclass correlation coefficient was 0.84, and item homogeneity was 0.52. Exploratory and confirmatory factor analysis (CFI = 0.99, RMSEA = 0.07) confirmed CISI-PD's unifactorial structure. The CISI-PD showed adequate convergent validity with SCOPA-COG and SCOPA-M (r(S) = 0.46-0.85, respectively) and discriminative validity for HY stages and disease duration (P < 0.0001). In a multiple regression model, main CISI-PD predictors were SCOPA-M, disease duration, and depression. The results obtained were not only comparable to but also extended those yielded by the preliminary validation study, thus showing that the CISI-PD is a valid instrument to measure clinical impression of severity in PD. Its simplicity and easy application make it an attractive and useful tool for clinical practice and research.

Clinical studies in orthodontics--an overview of NIDR-sponsored clinical orthodontic studies in the US.

PubMed

Baumrind, S

1998-11-01

A number of clinical trials sponsored by the National Institutes of Health (NIH) use rigorous methods of data acquisition and analysis previously developed in fundamental biology and the physical sciences. The naive expectation that these trials would lead relatively rapidly to definitive answers concerning the therapeutic strategies and techniques under study is dispelled. This presentation focuses on delineating differences between the study of central tendencies and individual variation, more specifically on the strategy to study this variation: measure additional sources of variance within each patient at more timepoints and perhaps with greater precision. As rigorous orthodontic research is still in its infancy, the problem of defining the proper mix between prospective and retrospective trials is discussed. In view of the high costs of prospective clinical trials, many of the questions germane to orthodontics can be answered by well-conducted retrospective trials, assuming that properly randomized sampling procedures are employed. Definitive clinical trials are likely to require better theoretical constructs, better instrumentation, and better measures than now available. Reasons for concern are the restricted resources available and the fact that current mensurational approaches may not detect many of the individual differences. The task of constructing sharable databases and record bases stored in digital form and available either remotely from servers, or locally from CD-ROMs or optical disks, is crucial to the optimization of future investigations.

Developing Medicare Competitive Bidding: A Study of Clinical Laboratories

PubMed Central

Hoerger, Thomas J.; Meadow, Ann

1997-01-01

Competitive bidding to derive Medicare fees promises several advantages over administered fee systems. The authors show how incentives for cost savings, quality, and access can be incorporated into bidding schemes, and they report on a study of the clinical laboratory industry conducted in preparation for a bidding demonstration. The laboratory industry is marked by variable concentration across geographic markets and, among firms themselves, by social and economic heterogeneity. The authors conclude that these conditions can be accommodated by available bidding design options and by careful selection of bidding markets. PMID:10180003

Study Shows India Can Integrate 175 GW of Renewable Energy into Its

Science.gov Websites

Electricity Grid | News | News | NREL Study Shows India Can Integrate 175 GW of Renewable Energy into Its Electricity Grid News Release: Study Shows India Can Integrate 175 GW of Renewable Energy Corporation, Ltd. (POSOCO); and Lawrence Berkeley National Laboratory (LBNL) produced the study Greening the

Learning by playing: A cross-sectional descriptive study of nursing students' experiences of learning clinical reasoning.

PubMed

Koivisto, Jaana-Maija; Multisilta, Jari; Niemi, Hannele; Katajisto, Jouko; Eriksson, Elina

2016-10-01

Clinical reasoning is viewed as a problem-solving activity; in games, players solve problems. To provide excellent patient care, nursing students must gain competence in clinical reasoning. Utilising gaming elements and virtual simulations may enhance learning of clinical reasoning. To investigate nursing students' experiences of learning clinical reasoning process by playing a 3D simulation game. Cross-sectional descriptive study. Thirteen gaming sessions at two universities of applied sciences in Finland. The prototype of the simulation game used in this study was single-player in format. The game mechanics were built around the clinical reasoning process. Nursing students from the surgical nursing course of autumn 2014 (N=166). Data were collected by means of an online questionnaire. In terms of the clinical reasoning process, students learned how to take action and collect information but were less successful in learning to establish goals for patient care or to evaluate the effectiveness of interventions. Learning of the different phases of clinical reasoning process was strongly positively correlated. The students described that they learned mainly to apply theoretical knowledge while playing. The results show that those who played digital games daily or occasionally felt that they learned clinical reasoning by playing the game more than those who did not play at all. Nursing students' experiences of learning the clinical reasoning process by playing a 3D simulation game showed that such games can be used successfully for learning. To ensure that students follow a systematic approach, the game mechanics need to be built around the clinical reasoning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pros and Cons of Clinical Pathway Software Management: A Qualitative Study.

PubMed

Aarnoutse, M F; Brinkkemper, S; de Mul, M; Askari, M

2018-01-01

In this study we aimed to assess the perceived effectiveness of clinical pathway management software for healthcare professionals. A case study on the clinical pathway management software program Check-It was performed in three departments at an academic medical center. Four months after the implementation of the software, interviews were held with healthcare professionals who work with the system. The interview questions were posed in a semi-structured interview format and the participant were asked about the perceived positive or negative effects of Check-It, and whether they thought the software is effective for them. The interviews were recorded and transcribed based on grounded theory, using different coding techniques. Our results showed fewer overlooked tasks, pre-filled orders and letters, better overview, and increased protocol insight as positive aspects of using the software. Being not flexible enough was experienced as a negative aspect.

Clinical study in genital herpes: natural Gene-Eden-VIR/Novirin versus acyclovir, valacyclovir, and famciclovir.

PubMed

Polansky, Hanan; Javaherian, Adrian; Itzkovitz, Edan

2016-01-01

This paper reports the results of a clinical study that tested the effect of suppressive treatment with the botanical product Gene-Eden-VIR/Novirin on the number of genital herpes outbreaks. The results in this study were compared to those published in clinical studies of acyclovir, valacyclovir, and famciclovir. The framework was a retrospective chart review. The population included 139 participants. The treatment was one to four capsules of Gene-Eden-VIR/Novirin per day. The duration of treatment was 2-48 months. The study included three controls recommended by the US Food and Drug Administration (FDA): baseline, no treatment, and dose response. The treatment decreased the number of outbreaks per year in 90.8% of the participants. The treatment also decreased the mean number of outbreaks per year from 7.27 and 5.5 in the control groups to 2.39 (P<0.0001 and P<0.001, respectively). The treated participants reported no adverse experiences. Out of the 15 tests that compared Gene-Eden-VIR/Novirin to the three drugs, Gene-Eden-VIR/Novirin had superior efficacy in eight tests, inferior efficacy in three tests, and comparable efficacy in four tests. Gene-Eden-VIR/Novirin also had superior safety. The clinical study showed that the natural Gene-Eden-VIR/Novirin decreases the number of genital herpes outbreaks without any side effects. The study also showed that the clinical effects reported in this study are mostly better than those reported in the reviewed studies of acyclovir, valacyclovir, and famciclovir.

The effect of periodontal treatment on C-reactive protein: A clinical study.

PubMed

Kumar, Santosh; Shah, Samir; Budhiraja, Shilpa; Desai, Khushboo; Shah, Chirag; Mehta, Dhaval

2013-07-01

Chronic periodontitis in amultifactorial inflammatory disease which is caused by various microorganisms. Many studies have found close association between chronic periodontitis and C-reactive protein (CRP). CRPis an inflammatory marker which increases in all inflammatory condition. The present clinical study was designed to show the effect of periodontal treatment on the CRP levels of gingival crevicular fluid and to determine the effect of nonsurgical therapy in minimizing the CRP levels in chronic generalized periodontitis. Gingival crevicular fluid was collected using a micro capillary pipette that was hand calibrated at every 1 mm till 10 mm, from selected sites in the subjects on the 1st, 14th and 45th days. Decreased CRP levels of gingival crevicular fluid were observed at the end of the study. There was a 37% reduction in probing pocket depth and 45% gain in clinical attachment level and a reduction of about 57% after 14 days and 90% reduction of CRP levels in gingival crevicular fluid after 45 days. Thus, the results show that the presence of CRP level is more significant in gingival crevicular fluid and confirms the underlying inflammatory component of the disease activity in chronic periodontitis.

Management of gingival recession with acellular dermal matrix graft: A clinical study

PubMed Central

Balaji, V. R.; Ramakrishnan, T.; Manikandan, D.; Lambodharan, R.; Karthikeyan, B.; Niazi, Thanvir Mohammed; Ulaganathan, G.

2016-01-01

Aims and Objectives: Obtaining root coverage has become an important part of periodontal therapy. The aims of this studyare to evaluate the clinical efficacy of acellular dermal matrix graft in the coverage of denuded roots and also to examine the change in the width of keratinized gingiva. Materials and Methods: A total of 20 sites with more than or equal to 2 mm of recession depth were taken into the study, for treatment with acellular dermal matrix graft. The clinical parameters such as recession depth, recession width, width of keratinized gingiva, probing pocket depth (PD), and clinical attachment level (CAL) were measured at the baseline, 8th week, and at the end of the study (16th week). The defects were treated with a coronally positioned pedicle graft combined with acellular dermal matrix graft. Results: Out of 20 sites treated with acellular dermal matrix graft, seven sites showed complete root coverage (100%), and the mean root coverage obtained was 73.39%. There was a statistically significant reduction in recession depth, recession width, and probing PD. There was also a statistically significant increase in width of keratinized gingiva and also gain in CAL. The postoperative results were both clinically and statistically significant (P < 0.0001). Conclusion: The results of this study were esthetically acceptable to the patients and clinically acceptable in all cases. From this study, it may be concluded that acellular dermal matrix graft is an excellent substitute for autogenous graft in coverage of denuded roots. PMID:27829749

Cefepime shows good efficacy and no antibiotic resistance in pneumonia caused by Serratia marcescens and Proteus mirabilis - an observational study.

PubMed

Yayan, Josef; Ghebremedhin, Beniam; Rasche, Kurt

2016-03-23

Many antibiotics have no effect on Gram-positive and Gram-negative microbes, which necessitates the prescription of broad-spectrum antimicrobial agents that can lead to increased risk of antibiotic resistance. These pathogens constitute a further threat because they are also resistant to numerous beta-lactam antibiotics, as well as other antibiotic groups. This study retrospectively investigates antimicrobial resistance in hospitalized patients suffering from pneumonia triggered by Gram-negative Serratia marcescens or Proteus mirabilis. The demographic and clinical data analyzed in this study were obtained from the clinical databank of the HELIOS Clinic, Witten/Herdecke University, Wuppertal, Germany, for inpatients presenting with pneumonia triggered by S. marcescens or P. mirabilis from 2004 to 2014. An antibiogram was conducted for the antibiotics utilized as part of the management of patients with pneumonia triggered by these two pathogens. Pneumonia was caused by Gram-negative bacteria in 115 patients during the study period from January 1, 2004, to August 12, 2014. Of these, 43 (37.4 %) hospitalized patients [26 males (60.5 %, 95 % CI 45.9 %-75.1 %) and 17 females (39.5 %, 95 % CI 24.9 %-54.1 %)] with mean age of 66.2 ± 13.4 years had pneumonia triggered by S. marcescens, while 20 (17.4 %) patients [14 males (70 %, 95 % CI 49.9 %-90.1 %) and 6 females (30 %, 95 % CI 9.9 %-50.1 %)] with a mean age of 64.6 ± 12.8 years had pneumonia caused by P. mirabilis. S. marcescens showed an increased antibiotic resistance to ampicillin (100 %), ampicillin-sulbactam (100 %), and cefuroxime (100 %). P. mirabilis had a high resistance to tetracycline (100 %) and ampicillin (55 %). S. marcescens (P < 0.0001) and P. mirabilis (P = 0.0003) demonstrated no resistance to cefepime in these patients with pneumonia. S. marcescens and P. mirabilis were resistant to several commonly used antimicrobial agents, but showed no resistance to

Clinical study of an outbreak of Legionnaire's disease in Alcoy, Southeastern Spain.

PubMed

Fernández, J A; López, P; Orozco, D; Merino, J

2002-10-01

The aim of this study was to identify the clinical features of Legionnaires' disease, sudden outbreaks of which demand a quick and flexible clinical approach, particularly with regard to diagnosis and therapy. A prospective and comparative study based on a clinical protocol was performed during an outbreak of Legionnaires' disease in Alcoy, Spain. The outbreak was environmental in origin, linked to cooling towers. Data about epidemiological and clinical features, blood chemistry values, radiological and microbiological findings, and characteristics related to the clinical course of Legionnaires' disease were obtained for 357 patients admitted to hospital with community-acquired pneumonia (177 with Legionella pneumonia). Patients with Legionnaires' disease were younger (mean age, 65.3+/-16.5 years) and more likely to be smokers compared with patients with other types of pneumonia (28.8% vs. 11.1%; P<0.01). Moreover, they had not been admitted to any hospital because of pneumonia in the previous year. Patients with Legionnaires' disease had higher fever, more severe headache, and less expectoration as well as lower sodium blood levels (mean, 132.6+/-4.8 mmol/l vs. 135.7 mmol/l; P<0.01). Radiological studies also showed that fewer patients with Legionnaires' disease had pleural effusion (9% vs. 19.4% of those with non- Legionella pneumonia). The presence of headache, high fever, hyponatremia, scanty or null expectoration, and current cigarette smoking provides physicians with important clues for a high suspicion of Legionella pneumonia before the results of confirmatory laboratory tests are available.

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

PubMed Central

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing

Profiles of Urine Drug Test in Clinical Pain Patients vs Pain Research Study Subjects.

PubMed

Lee, Cheng-ting; Vo, Trang T; Cohen, Abigail S; Ahmed, Shihab; Zhang, Yi; Mao, Jianren; Chen, Lucy

2016-04-01

To examine similarities and differences in urine drug test (UDT) results in clinical pain patients and pain subjects participating in pain research studies. An observational study with retrospective chart review and data analysis. We analyzed 1,874 UDT results obtained from 1) clinical pain patients (Clinical Group; n = 1,529) and 2) pain subjects consented to participate in pain research studies (Research Group; n = 345). Since several medications such as opioids used in pain management are drugs of abuse (DOA) and can result in a positive UDT, we specifically identified those cases of positive UDT due to nonprescribed DOA and designated these cases as positive UDT with DOA (PUD). We found that 1) there was a higher rate of PUD in clinical pain patients (41.3%) than in pain research study subjects (14.8%); 2) although subjects in the Research Group were informed ahead of time that UDT will be conducted as a screening test, a substantial number (14.8%) of pain research study subjects still showed PUD; 3) there were different types of DOA between clinical pain patients (cannabinoids as the top DOA) and research study subjects (cocaine as the top DOA); and 4) a common factor associated with PUD was opioid therapy in both Clinical Group and Research Group. These results support previous findings that PUD is a common finding in clinical pain patients, particularly in those prescribed opioid therapy, and we suggest that UDT be used as routine screening testing in pain research studies. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Multiday Transcranial Direct Current Stimulation Causes Clinically Insignificant Changes in Childhood Dystonia: A Pilot Study.

PubMed

Bhanpuri, Nasir H; Bertucco, Matteo; Young, Scott J; Lee, Annie A; Sanger, Terence D

2015-10-01

Abnormal motor cortex activity is common in dystonia. Cathodal transcranial direct current stimulation may alter cortical activity by decreasing excitability while anodal stimulation may increase motor learning. Previous results showed that a single session of cathodal transcranial direct current stimulation can improve symptoms in childhood dystonia. Here we performed a 5-day, sham-controlled, double-blind, crossover study, where we measured tracking and muscle overflow in a myocontrol-based task. We applied cathodal and anodal transcranial direct current stimulation (2 mA, 9 minutes per day). For cathodal transcranial direct current stimulation (7 participants), 3 subjects showed improvements whereas 2 showed worsening in overflow or tracking error. The effect size was small (about 1% of maximum voluntary contraction) and not clinically meaningful. For anodal transcranial direct current stimulation (6 participants), none showed improvement, whereas 5 showed worsening. Thus, multiday cathodal transcranial direct current stimulation reduced symptoms in some children but not to a clinically meaningful extent, whereas anodal transcranial direct current stimulation worsened symptoms. Our results do not support transcranial direct current stimulation as clinically viable for treating childhood dystonia. © The Author(s) 2015.

Translating state-of-the-art spinal cord MRI techniques to clinical use: A systematic review of clinical studies utilizing DTI, MT, MWF, MRS, and fMRI

PubMed Central

Martin, Allan R.; Aleksanderek, Izabela; Cohen-Adad, Julien; Tarmohamed, Zenovia; Tetreault, Lindsay; Smith, Nathaniel; Cadotte, David W.; Crawley, Adrian; Ginsberg, Howard; Mikulis, David J.; Fehlings, Michael G.

2015-01-01

Background A recent meeting of international imaging experts sponsored by the International Spinal Research Trust (ISRT) and the Wings for Life Foundation identified 5 state-of-the-art MRI techniques with potential to transform the field of spinal cord imaging by elucidating elements of the microstructure and function: diffusion tensor imaging (DTI), magnetization transfer (MT), myelin water fraction (MWF), MR spectroscopy (MRS), and functional MRI (fMRI). However, the progress toward clinical translation of these techniques has not been established. Methods A systematic review of the English literature was conducted using MEDLINE, MEDLINE-in-Progress, Embase, and Cochrane databases to identify all human studies that investigated utility, in terms of diagnosis, correlation with disability, and prediction of outcomes, of these promising techniques in pathologies affecting the spinal cord. Data regarding study design, subject characteristics, MRI methods, clinical measures of impairment, and analysis techniques were extracted and tabulated to identify trends and commonalities. The studies were assessed for risk of bias, and the overall quality of evidence was assessed for each specific finding using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Results A total of 6597 unique citations were identified in the database search, and after full-text review of 274 articles, a total of 104 relevant studies were identified for final inclusion (97% from the initial database search). Among these, 69 studies utilized DTI and 25 used MT, with both techniques showing an increased number of publications in recent years. The review also identified 1 MWF study, 11 MRS studies, and 8 fMRI studies. Most of the studies were exploratory in nature, lacking a priori hypotheses and showing a high (72%) or moderately high (20%) risk of bias, due to issues with study design, acquisition techniques, and analysis methods. The acquisitions for each

Exploring the scope of expanding advanced nursing practice in nurse-led clinics: a multiple-case study.

PubMed

Shiu, Ann T Y; Lee, Diana T F; Chau, Janita P C

2012-08-01

This article is a report on a study to explore the development of expanding advanced nursing practice in nurse-led clinics in Hong Kong. Nurse-led clinics serviced by advanced practice nurses, a common international practice, have been adopted in Hong Kong since 1990s. Evaluations consistently show that this practice has good clinical outcomes and contributes to containing healthcare cost. However, similar to the international literature, it remains unclear as to what the elements of good advanced nursing practice are, and which directions Hong Kong should adopt for further development of such practice. A multiple-case study design was adopted with six nurse-led clinics representing three specialties as six case studies, and including two clinics each from continence, diabetes and wound care. Each case had four embedded units of analysis. They included non-participant observation of nursing activities (9 days), nurse interviews (N = 6), doctor interviews (N = 6) and client interviews (N = 12). The data were collected in 2009. Within- and cross-case analyses were conducted. The cross-case analysis demonstrated six elements of good advanced nursing practice in nurse-led clinics, and showed a great potential to expand the practice by reshaping four categories of current boundaries, including community-hospital, wellness-illness, public-private and professional-practice boundaries. From these findings, we suggest a model to advance the scope of advanced nursing practice in nurse-led clinics. The six elements may be applied as audit criteria for evaluation of advanced nursing practice in nurse-led clinics, and the proposed model provides directions for expanding such practice in Hong Kong and beyond. © 2011 Blackwell Publishing Ltd.

Admission interview scores are associated with clinical performance in an undergraduate physiotherapy course: an observational study.

PubMed

Edgar, Susan; Mercer, Annette; Hamer, Peter

2014-12-01

The purpose of this study was to determine if there is an association between admission interview score and subsequent academic and clinical performance, in a four-year undergraduate physiotherapy course. Retrospective observational study. 141 physiotherapy students enrolled in two entry year groups. Individual student performance in all course units, practical examinations, clinical placements as well as year level and overall Grade Point Average. Predictor variables included admission interview scores, admission academic scores and demographic data (gender, age and entry level). Interview score demonstrated a significant association with performance in three of six clinical placements through the course. This association was stronger than for any other admission criterion although effect sizes were small to moderate. Further, it was the only admission score to have a significant association with overall Clinical Grade Point Average for the two year groups analysed (r=0.322). By contrast, academic scores on entry showed significant associations with all year level Grade Point Averages except Year 4, the clinical year. This is the first study to review the predictive validity of an admission interview for entry into a physiotherapy course in Australia. The results show that performance in this admission interview is associated with overall performance in clinical placements through the course, while academic admission scoring is not. These findings suggest that there is a role for both academic and non-academic selection processes for entry into physiotherapy. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

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

Corticosteroid hypersensitivity studies in a skin allergy clinic.

PubMed

Berbegal, L; DeLeon, F J; Silvestre, J F

2015-12-01

Corticosteroids can cause hypersensitivity reactions, particularly delayed-type allergic reactions. A new classification system for testing hypersensitivity to corticosteroids distributes the drugs into 3 groups according to molecular structure; patients are classified according to whether they are allergic to agents in 1 or more of the groups. We aimed to describe the clinical characteristics of corticosteroid-allergic patients treated at our clinic and apply the new classification system to them; we also compared these patients' characteristics to those of others treated at our clinic. Retrospective study of cases of delayed-type corticosteroid hypersensitivity treated in the skin allergy clinic of a tertiary level hospital over an 11-year period. We reviewed the records of 2857 patients, finding 33 with at least one positive patch test result showing corticosteroid hypersensitivity. Atopic dermatitis and hand involvement were less common in our corticosteroid-allergic patients. All were allergic to a group 1 corticosteroid (most often, budesonide, the culprit in 87.9%). Testing with a specific corticosteroid series revealed that 14 (42.4%) were also allergic to corticosteroids in group 2 and/or group 3. None were allergic exclusively to group 2 or group 3 agents. Twenty-one patients were exposed to a corticosteroid cream from a group their patch test results indicated allergy to; 13 of them (61.9%) did not develop a hypersensitivity reaction. The Spanish standard series only contains group 1 corticosteroids. In the interest of improving allergy management, we recommend testing with a specific corticosteroid series and a patient's own creams whenever patch testing with a standard series reveals a hypersensitivity reaction to corticosteroids. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

CO2 study shows effects on scrub oak environment

NASA Technical Reports Server (NTRS)

2000-01-01

CO2 study site manager and plant physiologist Graham Hymus (left) examines scrub oak foliage while project engineer David Johnson (right) looks on. The life sciences study is showing that rising levels of carbon dioxide in our atmosphere, caused by the burning of fossil fuels, could spur plant growth globally. The site of KSC's study is a natural scrub oak area near the Vehicle Assembly Building. Twelve-foot areas of scrub oak have been enclosed in 16 open-top test chambers into which CO2 has been blown. Five scientists from NASA and the Smithsonian Environmental Research Center in Edgewater, Md., work at the site to monitor experiments and keep the site running. Scientists hope to continue the study another five to 10 years. More information on this study can be found in Release No. 57- 00.

The patient perspective of clinical training-an empirical study about patient motives to participate.

PubMed

Drevs, Florian; Gebele, Christoph; Tscheulin, Dieter K

2014-10-01

This study introduces a comprehensive model to explain patients' prosocial behavioral intentions to participate in clinical training. Using the helping decision model, the authors analyze the combined impact of factors that affect participation intentions. The model includes intrapersonal and interpersonal appraisals triggered by an awareness of the societal need for clinical training as a practical part of medical education. The results of our empirical study (N=317) show that personal costs and anxiety as negative appraisals and a warm glow as a positive appraisal affect participation intentions and fully mediate the effect of the patient's awareness of the societal need. The study results indicate that communication strategies should address patient beliefs about negative personal consequences of participation rather than highlighting the societal need for practical medical education related to clinical training. Based on the results, medical associations could develop guidelines and provide training for physicians on how to motivate patients to participate in clinical training, resulting in more patient-centered standardized consent discussions. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Clinical skills development in student-run free clinic volunteers: a multi-trait, multi-measure study.

PubMed

Nakamura, Mio; Altshuler, David; Chadwell, Margit; Binienda, Juliann

2014-12-12

At Wayne State University School of Medicine (WSU SOM), the Robert R. Frank Student Run Free Clinic (SRFC) is one place preclinical students can gain clinical experience. There have been no published studies to date measuring the impact of student-run free clinic (SRFC) volunteerism on clinical skills development in preclinical medical students. Surveys were given to first year medical students at WSU SOM at the beginning and end of Year 1 to assess perception of clinical skills, including self-confidence, self-reflection, and professionalism. Scores of the Year 1 Objective Structured Clinical Exam (OSCE) were compared between SRFC volunteers and non-volunteers. There were a total of 206 (68.2%) and 80 (26.5%) survey responses at the beginning and end of Year 1, respectively. Of the 80 students, 31 (38.7%) volunteered at SRFC during Year 1. Statistically significant differences were found between time points in self-confidence (p < 0.001) in both groups. When looking at self-confidence in skills pertaining to SRFC, the difference between groups was statistically significant (p = 0.032) at both time points. A total of 302 students participated in the Year 1 OSCE, 27 (9%) of which were SRFC volunteers. No statistically significant differences were found between groups for mean score (p = 0.888) and established level of rapport (p = 0.394). While this study indicated no significant differences in clinical skills in students who volunteer at the SRFC, it is a first step in attempting to measure clinical skill development outside of the structured medical school setting. The findings lend themselves to development of research designs, clinical surveys, and future studies to measure the impact of clinical volunteer opportunities on clinical skills development in future physicians.

PPB | What is a Clinical Study

Cancer.gov

The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

A Clinical Reasoning Tool for Virtual Patients: Design-Based Research Study.

PubMed

Hege, Inga; Kononowicz, Andrzej A; Adler, Martin

2017-11-02

Clinical reasoning is a fundamental process medical students have to learn during and after medical school. Virtual patients (VP) are a technology-enhanced learning method to teach clinical reasoning. However, VP systems do not exploit their full potential concerning the clinical reasoning process; for example, most systems focus on the outcome and less on the process of clinical reasoning. Keeping our concept grounded in a former qualitative study, we aimed to design and implement a tool to enhance VPs with activities and feedback, which specifically foster the acquisition of clinical reasoning skills. We designed the tool by translating elements of a conceptual clinical reasoning learning framework into software requirements. The resulting clinical reasoning tool enables learners to build their patient's illness script as a concept map when they are working on a VP scenario. The student's map is compared with the experts' reasoning at each stage of the VP, which is technically enabled by using Medical Subject Headings, which is a comprehensive controlled vocabulary published by the US National Library of Medicine. The tool is implemented using Web technologies, has an open architecture that enables its integration into various systems through an open application program interface, and is available under a Massachusetts Institute of Technology license. We conducted usability tests following a think-aloud protocol and a pilot field study with maps created by 64 medical students. The results show that learners interact with the tool but create less nodes and connections in the concept map than an expert. Further research and usability tests are required to analyze the reasons. The presented tool is a versatile, systematically developed software component that specifically supports the clinical reasoning skills acquisition. It can be plugged into VP systems or used as stand-alone software in other teaching scenarios. The modular design allows an extension with new

Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

2016-12-12

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

Poststroke Seizures and Epilepsy: Clinical Studies and Animal Models

PubMed Central

Kelly, Kevin M.

2002-01-01

Poststroke seizures and epilepsy have been described in numerous clinical studies for many years. Most studies are retrospective in design, include relatively small numbers of patients, have limited periods of follow-up, and report a diversity of findings. Well-designed clinical trials and population studies in the recent past addressed several critical clinical issues and generated important findings regarding the occurrence of poststroke seizures and epilepsy. In contrast, the pathophysiologic events of injured brain that establish poststroke epileptogenesis are not well understood, and animal modeling has had limited development. Reviews of several important clinical studies and animal models that hold promise for a better understanding of poststroke epileptogenesis are presented. PMID:15309107

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

PubMed Central

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

2014-01-01

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

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

PubMed

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

2014-01-01

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

An overview of clinical studies on fiber post systems.

PubMed

Dikbas, Idil; Tanalp, Jale

2013-01-01

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

An Overview of Clinical Studies on Fiber Post Systems

PubMed Central

Dikbas, Idil; Tanalp, Jale

2013-01-01

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

Quantitative imaging of the human upper airway: instrument design and clinical studies

NASA Astrophysics Data System (ADS)

Leigh, M. S.; Armstrong, J. J.; Paduch, A.; Sampson, D. D.; Walsh, J. H.; Hillman, D. R.; Eastwood, P. R.

2006-08-01

Imaging of the human upper airway is widely used in medicine, in both clinical practice and research. Common imaging modalities include video endoscopy, X-ray CT, and MRI. However, no current modality is both quantitative and safe to use for extended periods of time. Such a capability would be particularly valuable for sleep research, which is inherently reliant on long observation sessions. We have developed an instrument capable of quantitative imaging of the human upper airway, based on endoscopic optical coherence tomography. There are no dose limits for optical techniques, and the minimally invasive imaging probe is safe for use in overnight studies. We report on the design of the instrument and its use in preliminary clinical studies, and we present results from a range of initial experiments. The experiments show that the instrument is capable of imaging during sleep, and that it can record dynamic changes in airway size and shape. This information is useful for research into sleep disorders, and potentially for clinical diagnosis and therapies.

Pitavastatin: clinical effects from the LIVES Study.

PubMed

Teramoto, Tamio

2011-11-01

Although clinical trials provide useful information on drug safety and efficacy, results do not always reflect those observed in the real world. The Japanese long-term prospective post-marketing surveillance LIVALO Effectiveness and Safety (LIVES) Study was designed to assess the efficacy and safety of pitavastatin in clinical practice in ~20,000 patients. After 104 weeks, pitavastatin was associated with significant reductions in low-density lipoprotein-cholesterol (LDL-C) (29.1%) that largely occurred within 4 weeks of treatment initiation. In patients with abnormal triglyceride (TG) and high-density lipoprotein-cholesterol (HDL-C) levels at baseline, pitavastatin reduced TG and increased HDL-C by 22.7% and 19.9%, respectively. Overall, 88.2% of the primary prevention low-risk patients attained their Japan Atherosclerosis Society LDL-C target, compared with 82.7% of intermediate-risk patients, 66.5% of high-risk patients and 50.3% of secondary prevention patients. Only 10.4% of pitavastatin-treated patients experienced adverse events (AEs), of which approximately 84% were mild and around 1% was severe. Increases in blood creatine phosphokinase (2.7%), alanine aminotransferase (1.8%), myalgia (1.1%), aspartate aminotransferase (1.5%) and gamma-glutamyltransferase (1.0%) were the most common AEs and only 7.4% of patients discontinued pitavastatin due to AEs. Regression analysis demonstrated that age was not a significant factor for the incidence of any AE or myopathy-associated events. A subanalysis of initial LIVES data focussing on the effects of pitavastatin on HDL-C levels showed that HDL-C was elevated by 5.9% in all patients and by 24.6% in those with low (showed that the elevation in HDL-C in the low-HDL-C group was enhanced by 14.0% and 24.9% at 12 weeks and 104 weeks, respectively. In contrast, previous studies have shown that other statins have inconsistent effects on HDL

Does Pharmacogenomic Testing Improve Clinical Outcomes for Major Depressive Disorder? A Systematic Review of Clinical Trials and Cost-Effectiveness Studies.

PubMed

Rosenblat, Joshua D; Lee, Yena; McIntyre, Roger S

2017-06-01

-sponsored study showed clinical improvement when pharmacogenomics testing guided prescribing; however, this study lacked a control group. A single cost-effectiveness study concluded that single gene testing was not cost-effective. Conversely, a separate study reported that combinatorial pharmacogenomic testing is cost-effective. A limited number of studies have shown promise for the clinical utility of pharmacogenomic testing; however, cost-effectiveness of pharmacogenomics, as well as demonstration of improved health outcomes, is not yet supported with replicated evidence. © Copyright 2017 Physicians Postgraduate Press, Inc.

[Exploratory study of clinical reasoning in nursing students with concept mapping].

PubMed

Paucard-Dupont, Sylvie; Marchand, Claire

2014-06-01

The training reference leading to the state nursing diploma places the learning of clinical reasoning at the center of the training. We have been wondering about the possibilities of making visible the student nurse's mental processes when they provide nursing care in order to identify their strategies and reasoning difficulties. It turns out that concept mapping is a research tool capable of showing these two aspects. The aim of this study is to verify a concept mapping made during an interview and built from the speech of a nursing student when analyzing a simulated clinical situation, is able to make visible its strategies clinical reasoning and reasoning difficulties. In a second phase of it, is to explore how the concept map once elaborated allows students to identify their own intellectual reasoning. 12 nursing second year students have participated in the study. Concept maps were constructed by the trainer/researcher as the students analyzed aloud a simulated clinical situation written. Concept maps were analyzed from a reference grid. Interviews were conducted following the elaboration of concept maps and student's comments were analyzed. Students reasoning strategies were either mixed inductive dominant (5/12) or hypothetical-deductive dominant (5/12). Reasoning difficulties identified are related to the lack of identification of important information, the lack of analysis of data, lack of connection or the existence of faulty links. Analysis of the comments highlights that concept mapping contributed to the development of metacognitive skills. The concept mapping has shown benefits in contributing to a diagnostic assessment of clinical reasoning learning. It is an additional resource tool to facilitate the development of metacognitive skills for students. This tool can be useful to implement support learning strategies in clinical reasoning.

Clinic-cytologic study of conjunctivochalasis and its relation to thyroid autoimmune diseases: prospective cohort study.

PubMed

de Almeida, Sandra Flavia Fiorentini; de Sousa, Luciene B; Vieira, Luis A; Chiamollera, Maria I; Barros, Jeison de N

2006-08-01

To determine the prevalence of conjunctivochalasis in patients with immune thyroid diseases, to determine whether there is any association between the 2 diseases, and to determine cytologic study of conjunctivochalasis through the cytology impression test. A clinical prospective cohort study carried out by the External Diseases Department in the Ophthalmology Sector and the Thyroid Department in the Endocrinology Sector at Federal University of Sao Paulo (UNIFESP). The patients included were divided into 2 groups following these inclusion criteria: a control group of 25 patients without thyroid diseases, confirmed after clinical and laboratory examinations (thyroid hormones), or any other ocular diseases. The study group consisted of 31 patients with thyroid diseases, the diagnosis of which was confirmed by the Endocrinology Sector. The thyroidopathies included were autoimmune diseases but excluded nonautoimmune diseases. A protocol endorsed by the UNIFESP was followed, using clinical and ophthalmological history, biomicroscopy, and impression cytology. Fifty-two percent of patients without thyroid diseases and 88% of patients with thyroid diseases presented with conjunctivochalasis. The risk ratio was 1.705 (Pr > chi(2) = 0.0038), indicating that there is an association between them. For the impression cytology in inferior bulbar conjunctiva, there was an association between the result of the impression cytology and conjunctivochalasis (Pearson chi(2) = 10.1190 Pr = 0.006). The prevalence of conjunctivochalasis in patients with autoimmune thyroid diseases was 88%. Patients with autoimmune thyroidopathy presented higher percentages of conjunctivochalasis than the control group, confirming the association between them. The cytologic study showed the highest prevalence of abnormal surface features in eyes with conjunctivochalasis.

A metadata approach for clinical data management in translational genomics studies in breast cancer.

PubMed

Papatheodorou, Irene; Crichton, Charles; Morris, Lorna; Maccallum, Peter; Davies, Jim; Brenton, James D; Caldas, Carlos

2009-11-30

In molecular profiling studies of cancer patients, experimental and clinical data are combined in order to understand the clinical heterogeneity of the disease: clinical information for each subject needs to be linked to tumour samples, macromolecules extracted, and experimental results. This may involve the integration of clinical data sets from several different sources: these data sets may employ different data definitions and some may be incomplete. In this work we employ semantic web techniques developed within the CancerGrid project, in particular the use of metadata elements and logic-based inference to annotate heterogeneous clinical information, integrate and query it. We show how this integration can be achieved automatically, following the declaration of appropriate metadata elements for each clinical data set; we demonstrate the practicality of this approach through application to experimental results and clinical data from five hospitals in the UK and Canada, undertaken as part of the METABRIC project (Molecular Taxonomy of Breast Cancer International Consortium). We describe a metadata approach for managing similarities and differences in clinical datasets in a standardized way that uses Common Data Elements (CDEs). We apply and evaluate the approach by integrating the five different clinical datasets of METABRIC.

Feasibility study of structured diagnosis methods for functional dyspepsia in Korean medicine clinics.

PubMed

Park, Jeong Hwan; Kim, Soyoung; Park, Jae-Woo; Ko, Seok-Jae; Lee, Sanghun

2017-12-01

Functional dyspepsia (FD) is the seventh most common disease encountered in Korean medicine (KM) clinics. Despite the large number of FD patients visiting KM clinics, the accumulated medical records have no utility in evidence development, due to being unstructured. This study aimed to construct a standard operating procedure (SOP) with appropriate structured diagnostic methods for FD, and assess the feasibility for use in KM clinics. Two rounds of professional surveys were conducted by 10 Korean internal medicine professors to select the representative diagnostic methods. A feasibility study was conducted to evaluate compliance and time required for using the structured diagnostic methods by three specialists in two hospitals. As per the results of the professional survey, five questionnaires and one basic diagnostic method were selected. An SOP was constructed based on the survey results, and a feasibility study showed that the SOP compliance score (out of 5) was 3.45 among the subjects, and 3.25 among the practitioners. The SOP was acceptable and was not deemed difficult to execute. The total execution time was 136.5 minutes, out of which the gastric emptying test time was 129 minutes. This feasibility study of the SOP with structured diagnostic methods for FD confirmed it was adequate for use in KM clinics. It is expected that these study findings will be helpful to clinicians who wish to conduct observational studies as well as to generate quantitative medical records to facilitate Big Data research.

Marketing and clinical trials: a case study

PubMed Central

Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-01-01

Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors. PMID:18028537

Marketing and clinical trials: a case study.

PubMed

Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-11-20

Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

Registered nurses' clinical reasoning in home healthcare clinical practice: A think-aloud study with protocol analysis.

PubMed

Johnsen, Hege Mari; Slettebø, Åshild; Fossum, Mariann

2016-05-01

The home healthcare context can be unpredictable and complex, and requires registered nurses with a high level of clinical reasoning skills and professional autonomy. Thus, additional knowledge about registered nurses' clinical reasoning performance during patient home care is required. The aim of this study is to describe the cognitive processes and thinking strategies used by recently graduated registered nurses while caring for patients in home healthcare clinical practice. An exploratory qualitative think-aloud design with protocol analysis was used. Home healthcare visits to patients with stroke, diabetes, and chronic obstructive pulmonary disease in seven healthcare districts in southern Norway. A purposeful sample of eight registered nurses with one year of experience. Each nurse was interviewed using the concurrent think-aloud technique in three different patient home healthcare clinical practice visits. A total of 24 home healthcare visits occurred. Follow-up interviews were conducted with each participant. The think-aloud sessions were transcribed and analysed using three-step protocol analysis. Recently graduated registered nurses focused on both general nursing concepts and concepts specific to the domains required and tasks provided in home healthcare services as well as for different patient groups. Additionally, participants used several assertion types, cognitive processes, and thinking strategies. Our results showed that recently graduated registered nurses used both simple and complex cognitive processes involving both inductive and deductive reasoning. However, their reasoning was more reactive than proactive. The results may contribute to nursing practice in terms of developing effective nursing education programmes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Ataluren in cystic fibrosis: development, clinical studies and where are we now?

PubMed

Zainal Abidin, Noreen; Haq, Iram J; Gardner, Aaron I; Brodlie, Malcolm

2017-09-01

Cystic fibrosis (CF) is one of the most common genetically-acquired life-limiting conditions worldwide. The underlying defect is dysfunction of the cystic fibrosis transmembrane-conductance regulator (CFTR) which leads to progressive lung disease and other multi-system effects. Around 10% of people with CF have a class I nonsense mutation that leads to production of shortened CFTR due to a premature termination codon (PTC). Areas covered: We discuss the discovery of the small-molecule drug ataluren, which in vitro has been shown to allow read-through of PTCs and facilitate synthesis of full-length protein. We review clinical studies that have been performed involving ataluren in CF. Early-phase short-term cross-over studies showed improvement in nasal potential difference. A follow-up phase III randomised controlled trial did not show a significant difference for the primary outcome of lung function, however a post-hoc analysis suggested possible benefit in patients not receiving tobramycin. A further randomised controlled trial in patients not receiving tobramycin has been reported as showing no benefit but has not yet been published in full peer-reviewed form. Expert opinion: A small-molecule approach to facilitate read-through of PTCs in nonsense mutations makes intuitive sense. However, at present there is no high-quality evidence of clinical efficacy for ataluren in people with CF.

Clinical Use of Tobramycin Inhalation Solution (TOBI®) Shows Sustained Improvement in FEV1 in Cystic Fibrosis

PubMed Central

Konstan, Michael W.; Wagener, Jeffrey S.; Pasta, David J.; Millar, Stefanie J.; Morgan, Wayne J.

2014-01-01

Objectives Tobramycin inhalation solution (TIS; TOBI®) has improved forced expiratory volume in 1 second (FEV1) in cystic fibrosis (CF) trials. Using data from the Epidemiologic Study of CF (ESCF), we assessed the change in level and trend of FEV1 % predicted (pred) over a 2-year period associated with initiation of TIS during routine clinical practice. Methods Patients age 8–38 years and in ESCF for ≥2 years before treatment with TIS as a chronic therapy were selected if they remained on therapy for 2 years, defined as being on TIS for at least 3 months per year (C-TIS group). Comparator intervals age 8–38 years used TIS <10% of the time. For each interval, we estimated the level and trend (rate of decline) in FEV1 % pred before and after the index using a piecewise linear mixed-effects model adjusted for potential confounders. Results During the 2-year pre-index period the C-TIS group (n = 2,534) had a more rapid decline in FEV1 (−2.49 vs. −1.39 % pred/yr) and a lower FEV1 at index (62.6 vs. 74.7 % pred) than the comparator group (N = 17,656 intervals). After starting chronic TIS, the FEV1 trend line over the 2-year post-index period was higher, but the comparator group’s FEV1 was essentially unchanged (difference 2.22, P < 0.001). Change in slope was not different between groups (0.06, P = 0.82). Conclusions Initiating chronic TIS therapy in the routine clinical care of patients with CF was associated with improvement in FEV1 % pred but no change in rate of decline, which means that this benefit was sustained over the 2 years studied. PMID:24019211

I-123 - FP-CIT pharmacokinetics and dosimetry show great potential for the evaluation of dopamine transporter system in clinical routine

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

Costa, D.C.; Walker, S.; Waddington, W.

1996-05-01

FP-CIT is a N-fluoropropyl analogue of the [2{beta}-carbomethoxy-3{beta}-(4-iodophenyl)tropane] which has been labelled with I-123 and developed as a new marker of the pre-synaptic dopamine transporter system. Its selective uptake in the striatum of non-human primates and human volunteers has been reported with advantageous faster brain kinetics than {beta}-CIT. In this pilot work we studied the whole body imaging kinetics of FP-CIT in one normal volunteer - NV (5, 60, 100, 360 minutes and 24 hours post-injection for 20 minutes each) and a drug-free patient with well established Parkinson`s disease - PD (100 minutes) after intravenous injection of 111 MBq. Bothmore » subjects had high resolution brain SPECT at 35 minutes and 3.5 hours post-injection. Percent of whole body uptake (geometric mean of anterior and posterior projections) in different organs, including total brain and basal ganglia shows rapid clearance from blood during the first hour with no significant change from 100 minutes to 24 hours. The basal ganglia uptake is approximately 0.4% of total body from 100 minutes onwards. Striatal uptake (ratio to frontal cortex) is different between subjects, mainly at 3.5 hours and more marked in the putamen: Calculated dosimetry (mSv/MBq) showed E.D.E.-0.034, and total doses to whole body - 0.01, total brain - 0.017, basal ganglia - 0.155, small intestine - 0.06, urinary bladder - 0.05 and liver - 0.03. These data confirm that FP-CIT has acceptable dosimetry with good pharmacokinetics enabling the study of pre-synaptic dopamine transport system in nigrostriatal degeneration with clinical SPECT at 3-4 hrs p.i.« less

Analysis of quantitative data obtained from toxicity studies showing non-normal distribution.

PubMed

Kobayashi, Katsumi

2005-05-01

The data obtained from toxicity studies are examined for homogeneity of variance, but, usually, they are not examined for normal distribution. In this study I examined the measured items of a carcinogenicity/chronic toxicity study with rats for both homogeneity of variance and normal distribution. It was observed that a lot of hematology and biochemistry items showed non-normal distribution. For testing normal distribution of the data obtained from toxicity studies, the data of the concurrent control group may be examined, and for the data that show a non-normal distribution, non-parametric tests with robustness may be applied.

Genome-wide association study of clinically defined gout identifies multiple risk loci and its association with clinical subtypes.

PubMed

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

2016-04-01

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. 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. 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). Our findings provide clues to better understand the pathogenesis of gout and will be useful for development of companion diagnostics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

New daily persistent headache: clinical and serological characteristics in a retrospective study.

PubMed

Meineri, P; Torre, E; Rota, E; Grasso, E

2004-10-01

We present a retrospective clinical study of 18 cases of new daily persistent headache (NDPH), a rare chronic headache, included in the fourth chapter of the II IHS classification; the pathophysiology of NDPH is unknown but a link with viral infections (especially Epstein-Barr virus (EBV)) has been suggested. Comparing our series with the other two published until now, we did not find any particular difference, as regards to clinical aspects. However, our laboratory tests show a recent herpes simplex virus infection in 42% and cytomegalovirus in 11% of cases; moreover we could not find any EBV infection. Our data suggest that viruses other than EBV can play a role in NDPH.

Clinical laboratory studies of disinfection with Sporicidin.

PubMed Central

Isenberg, H D

1985-01-01

The clinical microbiology laboratory evaluation of disinfectants can serve as a guide for their application to reduce hospital-acquired infections. The use of Sporicidin, a glutaraldehyde-phenol formulation, was evaluated by the application of modified MIC and MBC determinations for standard organisms. In addition, the effect of this formulation on bacteria that may proliferate in water at ambient temperatures was studied. This investigation indicated that such studies can help the clinical microbiologist to guide the use of disinfectants and sterilants for the maintenance of a safe hospital environment. PMID:3932457

A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study.

PubMed

Chan, Kevin

2007-12-04

The randomized controlled trial is the "gold standard" for evaluating the benefits and harms of interventions. The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness. Although the intention-to-treat analysis showed that participants who received either dark or milk chocolate were happier than those who received no additional chocolate, the actual-consumption analysis showed that there were no differences between any of the groups. The reason for this result is that many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial.

Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.

PubMed

Kanji, Salmaan; Hayes, Meghan; Ling, Adam; Shamseer, Larissa; Chant, Clarence; Edwards, David J; Edwards, Scott; Ensom, Mary H H; Foster, David R; Hardy, Brian; Kiser, Tyree H; la Porte, Charles; Roberts, Jason A; Shulman, Rob; Walker, Scott; Zelenitsky, Sheryl; Moher, David

2015-07-01

Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies. Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study. Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies. The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these

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

PubMed

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

2003-01-01

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

Patient engagement in clinical communication: an exploratory study.

PubMed

Chaboyer, Wendy; McMurray, Anne; Marshall, Andrea; Gillespie, Brigid; Roberts, Shelley; Hutchinson, Alison M; Botti, Mari; McTier, Lauren; Rawson, Helen; Bucknall, Tracey

2016-09-01

Existing practice strategies for actively involving patients in care during hospitalisation are poorly understood. The aim of this study was to explore how healthcare professionals engaged patients in communication associated with care transitions. An instrumental, collective case study approach was used to generate empirical data about patient transitions in care. A purposive sample of key stakeholders representing (i) patients and their families; (ii) hospital discharge planning team members; and (iii) healthcare professionals was recruited in five Australian health services. Individual and group semi-structured interviews were conducted to elicit detailed explanations of patient engagement in transition planning. Interviews lasted between 30 and 60 minutes and were digitally recorded and transcribed verbatim. Data collection and analysis were conducted simultaneously and continued until saturation was achieved. Thematic analysis was undertaken. Five themes emerged as follows: (i) organisational commitment to patient engagement; (ii) the influence of hierarchical culture and professional norms on patient engagement; (iii) condoning individual healthcare professionals' orientations and actions; (iv) understanding and negotiating patient preferences; and (v) enacting information sharing and communication strategies. Most themes illustrated how patient engagement was enabled; however, barriers also existed. Our findings show that strong organisational and professional commitment to patient-centred care throughout the organisation was a consistent feature of health services that actively engaged patients in clinical communication. Understanding patients' needs and preferences and having both formal and informal strategies to engage patients in clinical communication were important in how this involvement occurred. © 2016 Nordic College of Caring Science.

Radiological clinical trials: Proposal of a problem-finding questionnaire to improve study success.

PubMed

Valdora, Francesca; Bignotti, Bianca; Calabrese, Massimo; Houssami, Nehmat; Tagliafico, Alberto

2016-12-26

To develop a survey to help define the main problems in radiological clinical trials. Since 2006, we have managed seven different radiological clinical trials recruiting patients in academic and non-academic centres. We developed a preliminary questionnaire using a four-round Delphi approach to identify problems occurring in radiological clinical trials run at our centre. We investigated the recruitment experience, involvement of all multi-disciplinary team members and main obstacles to completing the projects. A final round of Delphi processes elucidated solutions to the identified problems. Among 19/20 (95%) respondents, 10 (53%) were young physicians (under 35 years old), and the respondents included non-faculty members, fellows, residents, and undergraduate students. Ninety-four percent (18/19) of respondents showed interest in conducting clinical trials. On a scale of 1 to 10, the problems with higher/worse scores (8-9) were related to technical or communication problems. The most frequent problems across all studies were technical problems related to clinical trial equipment, insufficient willingness to participate, obstacles to understanding the design of electronic-case report form and extra work. The developed questionnaire identified the main recurring problems in radiological clinical trials as perceived by end-users and helped define possible solutions that are mostly related to having dedicated clinical trial research staff.

A clinical decision support system algorithm for intravenous to oral antibiotic switch therapy: validity, clinical relevance and usefulness in a three-step evaluation study.

PubMed

Akhloufi, H; Hulscher, M; van der Hoeven, C P; Prins, J M; van der Sijs, H; Melles, D C; Verbon, A

2018-04-26

To evaluate a clinical decision support system (CDSS) based on consensus-based intravenous to oral switch criteria, which identifies intravenous to oral switch candidates. A three-step evaluation study of a stand-alone CDSS with electronic health record interoperability was performed at the Erasmus University Medical Centre in the Netherlands. During the first step, we performed a technical validation. During the second step, we determined the sensitivity, specificity, negative predictive value and positive predictive value in a retrospective cohort of all hospitalized adult patients starting at least one therapeutic antibacterial drug between 1 and 16 May 2013. ICU, paediatric and psychiatric wards were excluded. During the last step the clinical relevance and usefulness was prospectively assessed by reports to infectious disease specialists. An alert was considered clinically relevant if antibiotics could be discontinued or switched to oral therapy at the time of the alert. During the first step, one technical error was found. The second step yielded a positive predictive value of 76.6% and a negative predictive value of 99.1%. The third step showed that alerts were clinically relevant in 53.5% of patients. For 43.4% it had already been decided to discontinue or switch the intravenous antibiotics by the treating physician. In 10.1%, the alert resulted in advice to change antibiotic policy and was considered useful. This prospective cohort study shows that the alerts were clinically relevant in >50% (n = 449) and useful in 10% (n = 85). The CDSS needs to be evaluated in hospitals with varying activity of infectious disease consultancy services as this probably influences usefulness.

Migraine patients consistently show abnormal vestibular bedside tests.

PubMed

Maranhão, Eliana Teixeira; Maranhão-Filho, Péricles; Luiz, Ronir Raggio; Vincent, Maurice Borges

2016-01-01

Migraine and vertigo are common disorders, with lifetime prevalences of 16% and 7% respectively, and co-morbidity around 3.2%. Vestibular syndromes and dizziness occur more frequently in migraine patients. We investigated bedside clinical signs indicative of vestibular dysfunction in migraineurs. To test the hypothesis that vestibulo-ocular reflex, vestibulo-spinal reflex and fall risk (FR) responses as measured by 14 bedside tests are abnormal in migraineurs without vertigo, as compared with controls. Cross-sectional study including sixty individuals - thirty migraineurs, 25 women, 19-60 y-o; and 30 gender/age healthy paired controls. Migraineurs showed a tendency to perform worse in almost all tests, albeit only the Romberg tandem test was statistically different from controls. A combination of four abnormal tests better discriminated the two groups (93.3% specificity). Migraine patients consistently showed abnormal vestibular bedside tests when compared with controls.

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

PubMed

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

Perception versus reality: a comparative study of the clinical judgment skills of nurses during a simulated activity.

PubMed

Fenske, Cynthia L; Harris, Margaret A; Aebersold, Michelle L; Hartman, Laurie S

2013-09-01

This study was conducted to determine how closely nurses' perceptions of their clinical judgment abilities matched their demonstrated clinical judgment skills during a simulation. Seventy-four registered nurses participated in a simulation using a video format. After the simulation, the nurses self-assessed their performance using the Lasater Clinical Judgment Rubric. This rubric was then used to rate the nurses' actual performance in the simulation activity. The study results showed a significant discrepancy between nurses' perceptions of their own clinical judgment abilities and their demonstrated clinical judgment skills. Age and length of nursing experience enhanced the difference between the findings of self-assessment and actual performance. Younger nurses and those with 1 year or less of nursing experience were significantly more likely to have self-assessed their abilities at a much higher level compared with their actual skills. Copyright 2013, SLACK Incorporated.

Merging clinical chemistry biomarker data with a COPD database - building a clinical infrastructure for proteomic studies.

PubMed

Eriksson, Jonatan; Andersson, Simone; Appelqvist, Roger; Wieslander, Elisabet; Truedsson, Mikael; Bugge, May; Malm, Johan; Dahlbäck, Magnus; Andersson, Bo; Fehniger, Thomas E; Marko-Varga, György

2016-01-01

Data from biological samples and medical evaluations plays an essential part in clinical decision making. This data is equally important in clinical studies and it is critical to have an infrastructure that ensures that its quality is preserved throughout its entire lifetime. We are running a 5-year longitudinal clinical study, KOL-Örestad, with the objective to identify new COPD (Chronic Obstructive Pulmonary Disease) biomarkers in blood. In the study, clinical data and blood samples are collected from both private and public health-care institutions and stored at our research center in databases and biobanks, respectively. The blood is analyzed by Mass Spectrometry and the results from this analysis then linked to the clinical data. We built an infrastructure that allows us to efficiently collect and analyze the data. We chose to use REDCap as the EDC (Electronic Data Capture) tool for the study due to its short setup-time, ease of use, and flexibility. REDCap allows users to easily design data collection modules based on existing templates. In addition, it provides two functions that allow users to import batches of data; through a web API (Application Programming Interface) as well as by uploading CSV-files (Comma Separated Values). We created a software, DART (Data Rapid Translation), that translates our biomarker data into a format that fits REDCap's CSV-templates. In addition, DART is configurable to work with many other data formats as well. We use DART to import our clinical chemistry data to the REDCap database. We have shown that a powerful and internationally adopted EDC tool such as REDCap can be extended so that it can be used efficiently in proteomic studies. In our study, we accomplish this by using DART to translate our clinical chemistry data to a format that fits the templates of REDCap.

Competence of novice nurses: role of clinical work during studying

PubMed Central

Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

2015-01-01

Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period. PMID:28316703

Data Linkage from Clinical to Study Databases via an R Data Warehouse User Interface. Experiences from a Large Clinical Follow-up Study.

PubMed

Kaspar, Mathias; Ertl, Maximilian; Fette, Georg; Dietrich, Georg; Toepfer, Martin; Angermann, Christiane; Störk, Stefan; Puppe, Frank

2016-08-05

Data that needs to be documented for clinical studies has often been acquired and documented in clinical routine. Usually this data is manually transferred to Case Report Forms (CRF) and/or directly into an electronic data capture (EDC) system. To enhance the documentation process of a large clinical follow-up study targeting patients admitted for acutely decompensated heart failure by accessing the data created during routine and study visits from a hospital information system (HIS) and by transferring it via a data warehouse (DWH) into the study's EDC system. This project is based on the clinical DWH developed at the University of Würzburg. The DWH was extended by several new data domains including data created by the study team itself. An R user interface was developed for the DWH that allows to access its source data in all its detail, to transform data as comprehensively as possible by R into study-specific variables and to support the creation of data and catalog tables. A data flow was established that starts with labeling patients as study patients within the HIS and proceeds with updating the DWH with this label and further data domains at a daily rate. Several study-specific variables were defined using the implemented R user interface of the DWH. This system was then used to export these variables as data tables ready for import into our EDC system. The data tables were then used to initialize the first 296 patients within the EDC system by pseudonym, visit and data values. Afterwards, these records were filled with clinical data on heart failure, vital parameters and time spent on selected wards. This solution focuses on the comprehensive access and transformation of data for a DWH-EDC system linkage. Using this system in a large clinical study has demonstrated the feasibility of this approach for a study with a complex visit schedule.

Relationship between reflection ability and clinical performance: a cross-sectional and retrospective-longitudinal correlational cohort study in midwifery.

PubMed

Embo, M; Driessen, E; Valcke, M; van der Vleuten, C P M

2015-01-01

increasingly, reflection is highlighted as integral to core practice competencies but empirical research into the relationship between reflection and performance in the clinical workplace is scarce. this study investigated the relationship between reflection ability and clinical performance. we designed a cross-sectional and a retrospective-longitudinal cohort study. Data from first, second and third year midwifery students were collected to study the variables 'clinical performance' and 'reflection ability'. Data were analysed with SPSS for Windows, Release 20.0. Descriptive statistics, Pearson׳s Product Moment Correlation Coefficients (r) and r² values were computed to investigate associations between the research variables. the results showed a moderate observed correlation between reflection ability and clinical performance scores. When adopting a cross-sectional perspective, all correlation values were significant (p<0.01) and above 0.4, with the exception of the third year correlations. Assuming perfect reliability in the measurement, the adjusted correlations, for year 2 and year 3 indicated a high association between reflection ability and clinical performance (>0.6). The results based on the retrospective-longitudinal data set explained a moderate proportion of the variance after correction for attenuation. Finally, the results indicate that 'reflection ability' scores of earlier years are significant related with 'clinical performance' scores of subsequent years. These results suggest that (1) reflection ability is linked to clinical performance; (2) that written reflections are an important, but not the sole way to assess professional competence and that (3) reflection is a contributor to clinical performance improvement. the data showed a moderate but significant relationship between 'reflection ability' and 'clinical performance' scores in clinical practice of midwifery students. Reflection therefore seems an important component of professional

A study on the characterization of Propionibacterium acnes isolated from ocular clinical specimens.

PubMed

Sowmiya, Murali; Malathi, Jambulingam; Swarnali, Sen; Priya, Jeyavel Padma; Therese, Kulandai Lily; Madhavan, Hajib N

2015-10-01

There are only a few reports available on characterization of Propionibacterium acnes isolated from various ocular clinical specimens. We undertook this study to evaluate the role of P. acnes in ocular infections and biofilm production, and also do the phylogenetic analysis of the bacilli. One hundred isolates of P. acnes collected prospectively from ocular clinical specimens at a tertiary care eye hospital between January 2010 and December 2011, were studied for their association with various ocular disease conditions. The isolates were also subjected to genotyping and phylogenetic analysis, and were also tested for their ability to produce biofilms. Among preoperative conjunctival swabs, P. acnes was a probably significant pathogen in one case; a possibly significant pathogen in two cases. In other clinical conditions, 13 per cent isolates were probably significant pathogens and 38 per cent as possibly significant pathogens. The analysis of 16S rRNA gene revealed four different phylogenies whereas analysis of recA gene showed two phylogenies confirming that recA gene was more reliable than 16S rRNA with less sequence variation. Results of polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) had 100 per cent concordance with phylogenetic results. No association was seen between P. acnes subtypes and biofilm production. RecA gene phylogenetic studies revealed two different phylogenies. RFLP technique was found to be cost-effective with high sensitivity and specificity in phylogenetic analysis. No association between P. acnes subtypes and pathogenetic ability was observed. Biofilm producing isolates showed increased antibiotic resistance compared with non-biofilm producing isolates.

Clinical cardiac regenerative studies in children.

PubMed

Pavo, Imre J; Michel-Behnke, Ina

2017-02-26

Although the incidence of pediatric heart failure is low, the mortality is relatively high, with severe clinical symptoms requiring repeated hospitalization or intensive care treatment in the surviving patients. Cardiac biopsy specimens have revealed a higher number of resident human cardiac progenitor cells, with greater proliferation and differentiation capacity, in the neonatal period as compared with adults, demonstrating the regeneration potential of the young heart, with rising interest in cardiac regeneration therapy in critically ill pediatric patients. We review here the available literature data, searching the MEDLINE, Google Scholar and EMBASE database for completed, and www.clinicaltrials.gov homepage for ongoing studies involving pediatric cardiac regeneration reports. Because of difficulties conducting randomized blinded clinical trials in pediatric patients, mostly case reports or cohort studies with a limited number of individuals have been published in the field of pediatric regenerative cardiology. The majority of pediatric autologous cell transplantations into the cardiac tissue have been performed in critically ill children with severe or terminal heart failure. Congenital heart disease, myocarditis, and idiopathic hypertrophic or dilated cardiomyopathy leading to congestive heart failure are some possible areas of interest for pediatric cardiac regeneration therapy. Autologous bone marrow mononuclear cells, progenitor cells, or cardiospheres have been applied either intracoronary or percutaneously intramyocardially in severely ill children, leading to a reported clinical benefit of cell-based cardiac therapies. In conclusion, compassionate use of autologous stem cell administration has led to at least short-term improvement in heart function and clinical stability in the majority of the critically ill pediatric patients.

Prospective Clinical Study of Precision Oncology in Solid Tumors.

PubMed

Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

2015-11-09

Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

ERIC Educational Resources Information Center

Chester, Victoria

2011-01-01

Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

Ibuprofen reverts antifungal resistance on Candida albicans showing overexpression of CDR genes.

PubMed

Ricardo, Elisabete; Costa-de-Oliveira, Sofia; Dias, Ana Silva; Guerra, José; Rodrigues, Acácio Gonçalves; Pina-Vaz, Cidália

2009-06-01

Several mechanisms may be associated with Candida albicans resistance to azoles. Ibuprofen was described as being able to revert resistance related to efflux activity in Candida. The aim of this study was to uncover the molecular base of antifungal resistance in C. albicans clinical strains that could be reverted by ibuprofen. Sixty-two clinical isolates and five control strains of C. albicans were studied: the azole susceptibility phenotype was determined according to the Clinical Laboratory for Standards Institute, M27-A2 protocol and minimal inhibitory concentration values were recalculated with ibuprofen (100 microg mL(-1)); synergistic studies between fluconazole and FK506, a Cdr1p inhibitor, were performed using an agar disk diffusion assay and were compared with ibuprofen results. Gene expression was quantified by real-time PCR, with and without ibuprofen, regarding CDR1, CDR2, MDR1, encoding for efflux pumps, and ERG11, encoding for azole target protein. A correlation between susceptibility phenotype and resistance gene expression profiles was determined. Ibuprofen and FK506 showed a clear synergistic effect when combined with fluconazole. Resistant isolates reverting to susceptible after incubation with ibuprofen showed CDR1 and CDR2 overexpression especially of the latter. Conversely, strains that did not revert displayed a remarkable increase in ERG11 expression along with CDR genes. Ibuprofen did not alter resistance gene expression significantly (P>0.05), probably acting as a Cdrp blocker.

Blood volume analysis: a new technique and new clinical interest reinvigorate a classic study.

PubMed

Manzone, Timothy A; Dam, Hung Q; Soltis, Daniel; Sagar, Vidya V

2007-06-01

Blood volume studies using the indicator dilution technique and radioactive tracers have been performed in nuclear medicine departments for over 50 y. A nuclear medicine study is the gold standard for blood volume measurement, but the classic dual-isotope blood volume study is time-consuming and can be prone to technical errors. Moreover, a lack of normal values and a rubric for interpretation made volume status measurement of limited interest to most clinicians other than some hematologists. A new semiautomated system for blood volume analysis is now available and provides highly accurate results for blood volume analysis within only 90 min. The availability of rapid, accurate blood volume analysis has brought about a surge of clinical interest in using blood volume data for clinical management. Blood volume analysis, long a low-volume nuclear medicine study all but abandoned in some laboratories, is poised to enter the clinical mainstream. This article will first present the fundamental principles of fluid balance and the clinical means of volume status assessment. We will then review the indicator dilution technique and how it is used in nuclear medicine blood volume studies. We will present an overview of the new semiautomated blood volume analysis technique, showing how the study is done, how it works, what results are provided, and how those results are interpreted. Finally, we will look at some of the emerging areas in which data from blood volume analysis can improve patient care. The reader will gain an understanding of the principles underlying blood volume assessment, know how current nuclear medicine blood volume analysis studies are performed, and appreciate their potential clinical impact.

Tretinoin-loaded liposomal formulations: from lab to comparative clinical study in acne patients.

PubMed

Rahman, Salwa Abdel; Abdelmalak, Nevine Shawky; Badawi, Alia; Elbayoumy, Tahany; Sabry, Nermeen; El Ramly, Amany

2016-05-01

Topical tretinoin is the most commonly used retinoid for acne. However, its irritative potential on the applied area and the barrier properties of the stratum corneum limit its use. The objective of the present study was to formulate tretinoin liposomal gel to obtain a formula with lower skin irritation potential and greater clinical effect. A statistical 2(4) factorial design was adopted. Sixteen formulae prepared and were properly evaluated. A candidate formula (F13G) prepared with 0.025% tretinoin, phospholipid- cholesterol-dicetylphosphate (9:1:0.01) and incorporated in 1% carbopol gel was selected for skin irritation test. Clinical study was conducted on acne patients and compared to marketed product. All liposomes formulations were spherical in shape. The addition of cholesterol in the film hydration method significantly decreased the vesicle size, and increased the percentage of incorporation efficiency at (p < 0.05). The presence of dicetylphosphate significantly increased drug release but did not affect the percentage of incorporation efficiency and vesicle size. The results of the clinical study in acne patients revealed that F13G showed significantly higher efficacy when compared to marketed product (p < 0.05).

Clinical Studies with Epothilones

NASA Astrophysics Data System (ADS)

Altmann, Karl-Heinz

As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.

Clinical and histopathologic study of benign lichenoid keratosis on the face.

PubMed

Kim, Han Su; Park, Eun Joo; Kwon, In Ho; Kim, Kwang Ho; Kim, Kwang Joong

2013-10-01

Benign lichenoid keratosis is a cutaneous entity that consists of a nonpruritic papule or slightly indurated plaque that is histologically characterized by a band-like inflammatory infiltrate with interface involvement. The purpose of this study was to investigate the clinical and histopathologic features of benign lichenoid keratosis localized on the face. Fourteen benign lichenoid keratosis patients diagnosed clinically and histopathologically in our clinic during the 10-year period from 2002 to 2012 were studied. Thirteen female and 1 male patients were included. The mean age at diagnosis was 46.5 years. The color of most of the lesions was brown (10 cases, 71%). The cheek was the most commonly involved area (10 cases, 71%). All of the lesions were single. There were 9 (64%) flat lesion cases and 5 (36%) raised lesion cases. Most patients denied having any symptoms; 3 had mild pruritus. The histopathological findings indicated that all the cases exhibited lichenoid inflammatory infiltrate obscuring the dermal-epidermal junction and vacuolar alteration of basal cell layer. The lesions showed focal parakeratosis (79%), melanophages (79%), hyperkeratosis (71%), and necrotic keratinocytes (71%). Solar elastosis (50%) and acanthosis (43%) were also seen frequently. Diagnosis of benign lichenoid keratosis should be made by a combination of clinical manifestations and histopathological findings. In particular, benign lichenoid keratosis should be considered if a middle-aged patient presents a solitary asymptomatic brown lesion on the face. We think benign lichenoid keratosis may be a specific disorder rather than the inflammatory stage of regressing solar lentigines, large cell acanthoma or reticulated seborrheic keratosis.

Defining post-sternotomy mediastinitis for clinical evidence-based studies.

PubMed

van Wingerden, Jan J; de Mol, Bas A J M; van der Horst, Chantal M A M

2016-05-01

Considerable advances have already been made in the treatment of deep thoracic wound infections following a median sternotomy for cardiac surgery. Further improvement in diagnosis, treatment, and outcome will require a targeted approach by multidisciplinary teams. Clear communication and synergy between the various clinical and supportive disciplines would assist in removing the last barriers to standardized evidence-based studies and the development of improved evidence-based guidelines. An extensive literature search without language restrictions was carried out on PubMed (Medline), EMBASE, and Web of Science, covering the period 1988 to week 16, 2014, and a manual search of the reference lists was performed regarding all possible definitions and classifications of post-sternotomy mediastinitis. Two hundred and eighteen papers describing post-sternotomy infections in a multitude of terms were identified, and the strengths and weaknesses of the most popular definitions and terms relating specifically to post-sternotomy infections were examined. This study revealed that clinicians use a multitude of terms to describe post-sternotomy infections without defining the condition under treatment. Occasionally, older epidemiological (surveillance) definitions were used. It also shows that supportive disciplines have their own definitions, or interpretations of existing definitions, to describe these infections. The outcome of this study is that clinicians have adopted no single definition, which is essential for further improvement for evidence-based studies. We suggest that it is possible to adopt a single term for thoracic infection after a sternotomy (and only sternotomy), and propose a clinical definition for this purpose. © The Author(s) 2016.

Analyzing global trends of biomarker use in drug interventional clinical studies.

PubMed

Hayashi, K; Masuda, S; Kimura, H

2012-04-01

The trend of biomarker use in drug interventional clinical studies was analyzed using ClinicalTrials.gov to provide an overview of how biomarkers are used to streamline clinical studies and to examine regional differences. A total of 3,383 clinical study data was analyzed according to phase, region, sponsor, and therapeutic class. The number of clinical studies using biomarkers has been increasing constantly and is dependent on the number of Phase I and II studies. The majority of studies (58.5%) were sponsored by the United States, with the studies being conducted mainly in the sponsor's home region (80.3%). The use of biomarkers was prominent in the oncology area (37.1%). Although current data indicates some bias in the clinical use of biomarkers, it is expected that their use will increase in later phase studies or other therapeutic areas as biomarker development proceeds. In addition, limited regional use of biomarkers may lead to differences in biomarker use in drug development and in combination with political support may result in differences in competitiveness of drug development. Biomarkers would be a powerful tool against deteriorating research and development productivity when used more in appropriate clinical study conditions.

Extra-facial melasma: clinical, histopathological, and immunohistochemical case-control study.

PubMed

Ritter, C G; Fiss, D V C; Borges da Costa, J A T; de Carvalho, R R; Bauermann, G; Cestari, T F

2013-09-01

Extra-facial melasma is a prevalent dermatosis in some populations with special characteristics in relation to its clinical aspects and probable etiopathogenic factors. Few studies have attempted to address this alteration of pigmentation, which has become a challenge in clinical Dermatology. To assess the clinical histopathological and immunohistochemical characteristics of extra-facial melasma, comparing affected, and unaffected sites. Case-control study with 45 patients in each group (melasma and disease-free volunteers), assessing their clinical characteristics. In 36 patients, biopsies were performed on the lesion and the normal perilesional skin. Specimens were stained with HE and Fontana-Masson, and melanocytes analysed by immunohistochemistry. Objective measurements were accomplished by a specifically designed image analysis software. The melasma group had a mean age ± SD of 56.67 ± 8 years, the majority of them were women (86.7%) and 82.1% of the female cases had reached menopause. There were no significant differences between groups in terms of presence of comorbidities, use of medications or hormone therapies. For extra-facial melasma patients, family history of this dermatose and of previous facial melasma was significantly higher than in the control group (P < 0.05). The HE staining showed increased rectification and basal hyperpigmentation, solar elastosis, and collagen degeneration in the pigmented area (P < 0.05). There was a significant increase in melanin density in melasma biopsies, but the immunohistochemical tests did not detect a difference between the groups in terms of number of melanocytes. Extra-facial melasma appears to be related to menopause, family history, and personal history of facial melasma, in the studied population. Histopathology revealed a pattern similar to what has been described for facial melasma, with signs of solar degeneration, and a similar number of melanocytes, when comparing patients, and controls, suggesting that

A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study

PubMed Central

Chan, Kevin

2007-01-01

The randomized controlled trial is the “gold standard” for evaluating the benefits and harms of interventions. The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness. Although the intention-to-treat analysis showed that participants who received either dark or milk chocolate were happier than those who received no additional chocolate, the actual-consumption analysis showed that there were no differences between any of the groups. The reason for this result is that many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial. PMID:18056618

Why We Don’t Come: Patient Perceptions on No-Shows

PubMed Central

Lacy, Naomi L.; Paulman, Audrey; Reuter, Matthew D.; Lovejoy, Bruce

2004-01-01

PURPOSE Patients who schedule clinic appointments and fail to keep them have a negative impact on the workflow of a clinic in many ways. This study was conducted to identify the reasons patients in an urban family practice setting give for not keeping scheduled appointments. METHODS Semistructured interviews were conducted with 34 adult patients coming to the clinic for outpatient care. Interviews were audiotaped and transcribed verbatim. A multidisciplinary team used an immersion-crystallization organizing style to analyze the content of the qualitative interviews individually and in team meetings. RESULTS Participants identified 3 types of issues related to missing appointments without notifying the clinic staff: emotions, perceived disrespect, and not understanding the scheduling system. Although they discussed logistical issues of appointment keeping, participants did not identify these issues as key reasons for nonattendance. Appointment making among these participants was driven by immediate symptoms and a desire for self-care. At the same time, many of these participants experienced anticipatory fear and anxiety about both procedures and bad news. Participants did not feel obligated to keep a scheduled appointment in part because they felt disrespected by the health care system. The effect of this feeling was compounded by participants’ lack of understanding of the scheduling system. CONCLUSIONS The results of this study suggest that reducing no-show rates among patients who sometimes attend might be addressed by reviewing waiting times and participants’ perspectives of personal respect. PMID:15576538

Doctors' use of mobile devices in the clinical setting: a mixed methods study.

PubMed

Nerminathan, Arany; Harrison, Amanda; Phelps, Megan; Alexander, Shirley; Scott, Karen M

2017-03-01

Mobile device use has become almost ubiquitous in daily life and therefore includes use by doctors in clinical settings. There has been little study as to the patterns of use and impact this has on doctors in the workplace and how negatively or positively it impacts at the point of care. To explore how doctors use mobile devices in the clinical setting and understand drivers for use. A mixed methods study was used with doctors in a paediatric and adult teaching hospital in 2013. A paper-based survey examined mobile device usage data by doctors in the clinical setting. Focus groups explored doctors' reasons for using or refraining from using mobile devices in the clinical setting, and their attitudes about others' use. The survey, completed by 109 doctors, showed that 91% owned a smartphone and 88% used their mobile devices frequently in the clinical setting. Trainees were more likely than consultants to use their mobile devices for learning and accessing information related to patient care, as well as for personal communication unrelated to work. Focus group data highlighted a range of factors that influenced doctors to use personal mobile devices in the clinical setting, including convenience for medical photography, and factors that limited use. Distraction in the clinical setting due to use of mobile devices was a key issue. Personal experience and confidence in using mobile devices affected their use, and was guided by role modelling and expectations within a medical team. Doctors use mobile devices to enhance efficiency in the workplace. In the current environment, doctors are making their own decisions based on balancing the risks and benefits of using mobile devices in the clinical setting. There is a need for guidelines around acceptable and ethical use that is patient-centred and that respects patient privacy. © 2016 Royal Australasian College of Physicians.

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

PubMed

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

2016-01-01

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

Non-clinical immuno-toxicological evaluation of HER1 cancer vaccine in non-human primates: a 12-month study.

PubMed

Barro, Ana M Bada; Rivero, Arianna Iglesias; Goñi, Avelina León; Navarro, Bárbara O González; Angarica, Meilis Mesa; Ramírez, Belinda Sánchez; Bedoya, Darel Martínez; Triana, Consuelo González; Rodríguez, Axel Mancebo; Parada, Ángel Casacó

2012-12-17

Human epidermal growth factor receptor (HER1) constitutes a tumor associated antigen. Its overexpression in many epithelial tumors has been associated with bad prognosis and poor survival. Cancer vaccine based on the extracellular domain (ECD) of HER1 and adjuvated in very small sized proteoliposomes (VSSP) and Montanide ISA 51-VG is a new and complementary approach for the treatment of epithelial tumors. The present study deals with the immunogenicity of this vaccine in Macaca fascicularis monkeys and evaluation of its toxicity during 12 months. Twelve monkeys were randomized into two groups of 3 animals per sex: control and vaccinated. Treated monkeys received 9 doses of vaccination and were daily inspected for clinical signs. Body weight, rectal temperature, cardiac and respiratory rates were measured during the study. Humoral immune response, clinical pathology parameters and delayed type hypensensitivity were analyzed. Skin biopsy was performed at the end of the study in all animals. Animal's survival in the study was 100% (n=12). Local reactions were observed at the administration site of four treated animals (n=6), with two showing slight inflammatory cutaneous damage. Clinical pathology parameters were not affected. HER1 vaccine induced high IgG antibodies titers in the treated animals even when DTH was not observed. The induced antibodies recognized HER1+ tumor cell lines, decreased HER1 phosphorylation and showed anti-proliferative and pro-apoptotic effects in H125 cells. In general the present study showed that HER1 vaccine induced specific immune response in M. fascicularis monkeys and was well tolerated, suggesting it could be safely used in clinical studies in epithelial cancer patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

Anxiety in Parkinson's disease: a critical review of experimental and clinical studies.

PubMed

Prediger, Rui D S; Matheus, Filipe C; Schwarzbold, Marcelo L; Lima, Marcelo M S; Vital, Maria A B F

2012-01-01

Parkinson's disease (PD) is the second most common neurodegenerative disorder affecting about 1% of the population older than 60 years. Classically, PD is considered as a movement disorder, and its diagnosis is based on the presence of a set of cardinal motor signs that are the consequence of a pronounced death of dopaminergic neurons in the substantia nigra pars compacta. There is now considerable evidence showing that the neurodegenerative processes leading to sporadic PD begin many years before the appearance of the characteristic motor symptoms, and that additional neuronal fields and neurotransmitter systems are also involved in PD, including olfactory structures, amygdala, caudal raphe nuclei, locus coeruleus, and hippocampus. Accordingly, adrenergic and serotonergic neurons are also lost, which seems to contribute to the anxiety in PD. Non-motor features of PD usually do not respond to dopaminergic medication and probably form the major current challenge in the clinical management of PD. Additionally, most studies performed with animal models of PD have investigated their ability to induce motor alterations associated with advanced phases of PD, and some studies begin to assess non-motor behavioral features of the disease. The present review attempts to examine results obtained from clinical and experimental studies to provide a comprehensive picture of the neurobiology and current and potential treatments for anxiety in PD. The data reviewed here indicate that, despite their high prevalence and impact on the quality of life, anxiety disorders are often under-diagnosed and under-treated in PD patients. Moreover, there are currently few clinical and pre-clinical studies underway to investigate new pharmacological agents for relieving these symptoms, and we hope that this article may inspire clinicians and researchers devote to the studies on anxiety in PD to change this scenario. This article is part of a Special Issue entitled 'Anxiety and Depression

Activities of Tannins--From In Vitro Studies to Clinical Trials.

PubMed

Sieniawska, Elwira

2015-11-01

Tannins are considered as valuable plant secondary metabolites providing many benefits for human health. In this review information was gathered about bioactivity in vitro and in vivo, as well as about conducted clinical trials. The literature research was based on ScienceDirect, Scopus, and Cochrane databases and presents a wide range of tested activities of tannins. The described clinical trials verify laboratory tests and show the effective health benefits taken from supplementation with tannins.

Clinical studies of fiber posts: a literature review.

PubMed

Cagidiaco, Maria C; Goracci, Cecilia; Garcia-Godoy, Franklin; Ferrari, Marco

2008-01-01

This literature review aimed to find answers to relevant questions regarding the clinical outcome of endontically treated teeth restored with fiber posts. All clinical studies published since 1990 in journals indexed in MEDLINE were retrieved by searching PubMed with the query terms "fiber posts and clinical studies." The reference list of the collected articles was also screened for further relevant citations. The strength of the evidence provided by the reviewed papers was assessed according to the criteria of evidence-based dentistry. Five randomized controlled trials (RCTs) on fiber posts have been published in peer-reviewed journals. A meta-analysis is not applicable to these studies since they do not address the same specific clinical question. Retrospective and prospective trials without controls are also available. Two RCTs indicate that fiber-reinforced composite posts outperform metal posts in the restoration of endontically treated teeth. However, this evidence cannot be considered as conclusive. Longer-term RCTs would be desirable. The placement of a fiber-reinforced composite post protects against failure, especially under conditions of extensive coronal destruction. The most common type of failure with fiber-reinforced composite posts is debonding.

The case for introducing pre-registered confirmatory pharmacological pre-clinical studies.

PubMed

Kiwanuka, Olivia; Bellander, Bo-Michael; Hånell, Anders

2018-05-01

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan: one-year clinical outcomes (RECONFIRM-2)

PubMed Central

Takeuchi, Tsutomu; Inoue, Eisuke; Saito, Kazuyoshi; Sekiguchi, Naoya; Sato, Eri; Nawata, Masao; Kameda, Hideto; Iwata, Shigeru; Amano, Kouichi; Yamanaka, Hisashi

2008-01-01

Biologics targeting TNF have brought about a paradigm shift in the treatment of rheumatoid arthritis (RA) and infliximab, anti-TNF-α chimeric monoclonal antibody, was marketed in 2003 in Japan. We previously reported on the RECONFIRM study, a retrospective clinical study on the efficacy of infliximab therapy in a RA management group in Japan, where we evaluated the clinical response after 22 weeks of the therapy in 258 patients. The study reported here was aimed at reconfirming the clinical efficacy of the infliximab therapy and demographic factors related to the efficacy over a 54-week study period in 410 RA patients in the same study group. Infliximab was infused according to the domestically approved method, and the clinical response was evaluated following 54 weeks of infliximab therapy using the European League Against Rheumatism (EULAR) response criteria. Disease activity was assessed by DAS28-CRP (Disease Activity Score including a 28-joint count/C-reactive protein). Infliximab was discontinued in 24.4% of the 410 patients at 54 weeks and 9.3% and 8.1% discontinued the therapy due to adverse events and inefficiency, respectively. Average DAS28-CRP decreased from 5.5 at week 0 to 3.1 at week 54 after the therapy. Patients in remission and those showing low-, moderate-, and high-disease activity changed from 0.0, 1.0, 9.0 and 90.0%, respectively, at the start of the study to 27.6, 11.7, 34.4 and 26.3%, respectively, at week 54. Younger age, RF-negativity and low scores of DAS28-CRP showed significant correlations with remission at week 54. EULAR response criteria—good, moderate, and no response to infliximab—were 37.0, 41.7 and 21.2%, respectively. In conclusion, we reconfirmed the clinical efficacy of infliximab and demographic factors related to the efficacy over a 54-week study period in 410 Japanese patients with RA using DAS28-CRP and EULAR response criteria. PMID:18283523

An integrated model for the effects of self-reflection and clinical experiential learning on clinical nursing performance in nursing students: A longitudinal study.

PubMed

Pai, Hsiang-Chu

2016-10-01

The use of clinical simulation in undergraduate nursing programs in Taiwan has gradually increased over the past 5years. Previous research has shown that students' experience of anxiety during simulated laboratory sessions influences their self-reflection and learning effectiveness. Thus, further study that tracks what influences students' clinical performance in actual clinical sites is vital. The aim of the study is to develop an integrated model that considers the associations among anxiety, self-reflection, and learning effectiveness and to understand how this model applies to student nurses' clinical performance while on clinical placement. This study used a correlational and longitudinal study design. The 80 nursing students, who ranged in age from 19 to 21 (mean=20.38, SD=0.56), were recruited from a nursing school in southern Taiwan. Data were collected during three phases of implementation using four questionnaires. During the first phase, the State-Trait Anxiety Inventory (STAI), Simulation Learning Effectiveness Scale (SLES), and Self-Reflection and Insight Scale (SRIS) were used after students completed the simulation course in the school simulation laboratory. Nursing students also completed the Holistic Nursing Competence Scale at 2months (Phase 2) and 4months (Phase 3) after clinical practice experience. In Phase 3, students again completed the STAI and SRIS. Partial least squares (PLS), a structural equation modeling (SEM) procedure, was used to test the research model. The findings showed that: (1) at the start of the simulation laboratory, anxiety had a significant negative effect on students' simulation learning effectiveness (SLE; β=-0.14, p<0.05) and on self-reflection with insight (SRI; β=-0.52, p<0.01). Self-reflection also had a significant positive effect on simulation learning effectiveness (β=0.37, p<0.01). Anxiety had a significant negative effect on students' nursing competence during the first 2months of practice in a clinical

Efficacy of curcumin for age-associated cognitive decline: a narrative review of preclinical and clinical studies.

PubMed

Sarker, Marjana Rahman; Franks, Susan F

2018-04-21

Processes such as aberrant redox signaling and chronic low-grade systemic inflammation have been reported to modulate age-associated pathologies such as cognitive impairment. Curcumin, the primary therapeutic component of the Indian spice, Turmeric (Curcuma longa), has long been known for its strong anti-inflammatory and antioxidant activity attributable to its unique molecular structure. Recently, an interest in this polyphenol as a cognitive therapeutic for the elderly has emerged. The purpose of this paper is to critically review preclinical and clinical studies that have evaluated the efficacy of curcumin in ameliorating and preventing age-associated cognitive decline and address the translational progress of preclinical to clinical efficacy. PubMed, semantic scholar, and Google scholar searches were used for preclinical studies; and clinicaltrials.gov , the Australian and New Zealand clinical trials registry, and PubMed search were used to select relevant completed clinical studies. Results from preclinical studies consistently demonstrate curcumin and its analogues to be efficacious for various aspects of cognitive impairment and processes that contribute to age-associated cognitive impairment. Results of published clinical studies, while mixed, continue to show promise for curcumin's use as a therapeutic for cognitive decline but overall remain inconclusive at this time. Both in vitro and in vivo studies have found that curcumin can significantly decrease oxidative stress, systemic inflammation, and obstruct pathways that activate transcription factors that augment these processes. Future clinical studies would benefit from including evaluation of peripheral and cerebrospinal fluid biomarkers of dementia and behavioral markers of cognitive decline, as well as targeting the appropriate population.

[Clinical-epidemiological study in children with cleft lip palate in a secondary-level hospital].

PubMed

Pons-Bonals, Alicia; Pons-Bonals, Leticia; Hidalgo-Martínez, Sandra Margarita; Sosa-Ferreyra, Carlos Francisco

One of the most common congenital disorders that affects the facial structures is the cleft lip palate (CLP). The aim of this study was to generate the clinical-epidemiological profile of CLP patients from Hospital de Especialidades del Niño y la Mujer (HENM) Dr. Felipe Nuñez Lara, from the Ministry of Health, Queretaro, Mexico, from 2011 to 2014, who received treatment from the Cleft Lip Palate Clinic in order to provide interdisciplinary treatments for CLP patients based on the information from the pediatric records. Retrospective, cross-sectional, observational study using univariate analysis frequencies for qualitative variables; central statistical and dispersion for quantitative variables and clinical profile. One hundred records were reviewed, from which 15 were discarded for being syndromic cases. Epidemiological, clinical, and socio-demographic variables were studied. The epidemiological profile (variables associated with mother's pregnancy, patient's health at birth, nutritional and psychomotor development; family medical records, addictions, and socioeconomic factors) and clinical profile (disease classification by sex, structure, and side; surgeries classification and order in which they took place) of the treated population were registered. The results showed the need to standardize the data registration on medical records to improve the monitoring and treatment of patients and emphasize actions to maintain low incidence of CLP in Queretaro. Copyright © 2017 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

A Brief Course on Clinical Communication Skills: A Multi- Centered Study.

PubMed

Franco, Camila; Franco, Renato; Severo, Milton; Ferreira, Maria Amélia

2016-12-30

This paper describes and analyses the results of a multicenter course on clinical communication skills with the use of the learning in small groups, patient actors and feedback. The aim of the course was to encourage participants to develop a more effective clinical communication to recognize the different manifestations of the same disease in different patients (disease versus illness). The course was applied to third and fourth year medical students in three Brazilian universities and one university in Portugal. The evaluation was performed using scales regarding the participants' point of view, multiple choice questionnaire, a self-efficacy and attitudinal questionnaire. The study was conducted in 69 participants at the four universities. The overall evaluation of the course (from 1 - 5) was 4.70 (SD 0.494), the self-evaluation on participation was 4.07 (SD 0.671); and the evaluation about the use of simulated patients 4.51 (SD 0.501). The multiple choice questionnaire and self-efficacy scale showed significant improvement. The course methods had an excellent evaluation by students regardless of the context in which the course has been applied. Furthermore, it allowed an improvement on the knowledge and attitude of students regarding clinical communication. It was possible to develop a multi-centric learning strategy for clinical communication with a high evaluation by students who came from a Portuguese university in a cooperation project with teachers from Brazilian universities.

National questionnaire study on clinical ICT systems proofs: physicians suffer from poor usability.

PubMed

Viitanen, Johanna; Hyppönen, Hannele; Lääveri, Tinja; Vänskä, Jukka; Reponen, Jarmo; Winblad, Ilkka

2011-10-01

problems and deficiencies which considerably hindered the efficiency of clinical ICT use and physician's routine work. Systems lacked the appropriate features to support typical clinical tasks, such as decision making, prevention of medical errors, and review of a patient's treatment chart. The systems also required physicians to perform fixed sequences of steps and tasks, and poorly supported the documentation and retrieval of patient data. The findings on ICT support for collaboration showed mainly negative results, aside from collaboration between co-located physicians. In addition, the study results pointed out physicians suffering from system failures and a lack of integration between the systems. The described study and related results are unique in several ways. A national usability study with nearly 4000 respondents had not been conducted in other countries in which healthcare technologies are widely adopted. The questionnaire study provided a generalized picture about the usability problems, however, it should be noted that there were significant differences between legacy systems in use. Previously, researchers had not approached contextual aspects of usability the context of clinical work, where numerous systems are in use. The described usability dimensions and the presented study results can be considered as the first step towards conceptualizing ICT usability in the unique setting of clinical work. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

X-linked Charcot-Marie-Tooth (CMT) neuropathies (CMTX1, CMTX2, CMTX3) show different clinical phenotype and molecular genetics

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

Ionasescu, V.V.; Searby, C.C.; Ionasescu, R.

1994-09-01

The purpose of this study was to compare the X-linked dominant type CMTX1 (20 families) with X-linked recessive types CMTX2 and CMTX3 (2 families). The clinical phenotype was consistent with CMT peripheral neuropathy in all cases including distal weakness, atrophy and sensory loss, pes cavus and areflexia. Additional clinicial involvement of the central nervous system was present in one family with CMTX2 (mental retardation) and one family with CMTX3 (spastic paraparesis). Tight genetic linkage to Xq13.1 was present in 20 families with CMTX1 (Z=34.07 at {theta}=0) for the marker DXS453. Fifteen of the CMTX1 families showed point mutations of themore » connexin 32 coding region (5 nonsense mutations, 8 missense mutations, 2 deletions). Five CMTX1 neuropathy families showed no evidence of point mutations of the CX32 coding sequence. These findings suggest that the CMTX1 neuropathy genotype in these families may be the result of promoter mutations, 3{prime}-untranslated region mutations or exon/intron splice site mutations or a mutation with a different type of connexin but which has close structural similarities to CX32. No mutations of the CX32 coding region were found in the CMTX2 or CMTX3 families. Linkage to Xq13.1 was excluded in both families. Genetic linkage to Xp22.2 was present in the CMTX2 family (Z=3.54 at {theta}=0) for the markers DXS987 and DXS999. Suggestion of linkage to Xq26 (Z=1.81 at {theta}=0) for the marker DXS86 was present in the CMTX3 family.« less

Structural study of the exopolysaccharide produced by a clinical isolate of Burkholderia cepacia.

PubMed

Cescutti, P; Bosco, M; Picotti, F; Impallomeni, G; Leitão, J H; Richau, J A; Sá-Correia, I

2000-07-14

The primary structure of the exopolysaccharide produced by a clinical isolate of the bacterium Burkholderia cepacia was studied by means of methylation analysis, selective degradation, NMR spectroscopy, and electrospray mass spectrometry. The resulting data showed that the parent repeating unit of the exopolysaccharide is a highly branched heptasaccharide with the following structure: Two acetyl groups are present per repeating unit, as noncarbohydrate substituents. Copyright 2000 Academic Press.

Pathophysiology of pain in postherpetic neuralgia: a clinical and neurophysiological study.

PubMed

Truini, A; Galeotti, F; Haanpaa, M; Zucchi, R; Albanesi, A; Biasiotta, A; Gatti, A; Cruccu, G

2008-12-01

Postherpetic neuralgia is an exceptionally drug-resistant neuropathic pain. To investigate the pathophysiological mechanisms underlying postherpetic neuralgia we clinically investigated sensory disturbances, pains and itching, with an 11-point numerical rating scale in 41 patients with ophthalmic postherpetic neuralgia. In all the patients we recorded the blink reflex, mediated by non-nociceptive myelinated Abeta-fibers, and trigeminal laser evoked potentials (LEPs) related to nociceptive myelinated Adelta- and unmyelinated C-fiber activation. We also sought possible correlations between clinical sensory disturbances and neurophysiological data. Neurophysiological testing yielded significantly abnormal responses on the affected side compared with the normal side (P<0.001). The blink reflex delay correlated with the intensity of paroxysmal pain, whereas the Adelta- and C-LEP amplitude reduction correlated with the intensity of constant pain (P<0.01). Allodynia correlated with none of the neurophysiological data. Our study shows that postherpetic neuralgia impairs all sensory fiber groups. The neurophysiological-clinical correlations suggest that constant pain arises from a marked loss of nociceptive afferents, whereas paroxysmal pain is related to Abeta-fiber demyelination. These findings might be useful for a better understanding of pain mechanisms in postherpetic neuralgia.

Targeted Therapy Larotrectinib Shows Promise in Early Trials

Cancer.gov

The drug larotrectinib shrank tumors in patients with 13 different cancer types, results from three small clinical trials show. The drug, which targets tumors with TRK fusions, was effective in children and adults, this Cancer Currents post explains.

Expert clinical reasoning and pain assessment in mechanically ventilated patients: A descriptive study.

PubMed

Gerber, Anne; Thevoz, Anne-Laure; Ramelet, Anne-Sylvie

2015-02-01

Pain assessment in mechanically ventilated patients is challenging, because nurses need to decode pain behaviour, interpret pain scores, and make appropriate decisions. This clinical reasoning process is inherent to advanced nursing practice, but is poorly understood. A better understanding of this process could contribute to improved pain assessment and management. This study aimed to describe the indicators that influence expert nurses' clinical reasoning when assessing pain in critically ill nonverbal patients. This descriptive observational study was conducted in the adult intensive care unit (ICU) of a tertiary referral hospital in Western Switzerland. A purposive sample of expert nurses, caring for nonverbal ventilated patients who received sedation and analgesia, were invited to participate in the study. Data were collected in "real life" using recorded think-aloud combined with direct non-participant observation and brief interviews. Data were analysed using deductive and inductive content analyses using a theoretical framework related to clinical reasoning and pain. Seven expert nurses with an average of 7.85 (±3.1) years of critical care experience participated in the study. The patients had respiratory distress (n=2), cardiac arrest (n=2), sub-arachnoid bleeding (n=1), and multi-trauma (n=2). A total of 1344 quotes in five categories were identified. Patients' physiological stability was the principal indicator for making decision in relation to pain management. Results also showed that it is a permanent challenge for nurses to discriminate situations requiring sedation from situations requiring analgesia. Expert nurses mainly used working knowledge and patterns to anticipate and prevent pain. Patient's clinical condition is important for making decision about pain in critically ill nonverbal patients. The concept of pain cannot be assessed in isolation and its assessment should take the patient's clinical stability and sedation into account. Further

Case Study: Learner Physiotherapists' Perceptions of Clinical Education.

ERIC Educational Resources Information Center

Harris, Duncan; Naylor, Sandra

1992-01-01

Describes a study conducted in the United Kingdom to discover what processes learner physiotherapists experience in clinical education and whether their experience is comparable to that of other students in medical professions. The need for feedback is addressed, and the role of the clinical educator is discussed. A form for student assessment is…

The social well-being of nurses shows a thirst for a holistic support: A qualitative study.

PubMed

Mozaffari, Naser; Peyrovi, Hamid; Nayeri, Nahid Dehghan

2015-01-01

Social well-being is one of the important aspects of health. In fact, this is a reflection of experience in a social environment, indicating how social challenges are determined. In other words, social well-being is an explanation of people's perception and experience of being in a good situation, satisfaction with the structure, and social interaction. This qualitative study intended to explore nurses' experience of social well-being. Qualitative content analysis was used to conduct the study. Through purposive sampling, a total of 18 nurses with various clinical experiences participated in semi-structured interviews. The data were analysed using the five-step, qualitative content analysis introduced by Graneheim and Lundman. The main theme extracted from the data analysis was "thirst for a holistic support" in nurses. It consisted of two subthemes including internal support (family's support, colleague's support, and organizational support) and external support (society's support and media's support). Nurses' experiences in shaping their social well-being show that nurses need support in order to rebuild their social well-being. It is supported in partnership with the media, the community, health-related organizations, and by nurses and family. This improves job satisfaction, hope, motivation, commitment, and confidence so as to ultimately facilitate improvement of social well-being of nurses.

Atorvastatin, a double weapon in osteoporosis treatment: an experimental and clinical study.

PubMed

El-Nabarawi, Naglaa; El-Wakd, Mohamed; Salem, Mostafa

2017-01-01

The aim of this study was to evaluate the effect of atorvastatin on the bone formation and resorption markers in ovariectomized rats (experimental study), and to study its effect on the bone mineral density (BMD) in postmenopausal osteoporotic women (clinical study). The study involved experimental and clinical aspects. In the experimental aspect, 42 female Wistar rats were divided into five groups: Group I (n=6; sham-operated), Group II (n=6; 1 mL of carboxymethyl cellulose [CMC] was administered orally), Group III (n=6; 20 mg/kg orally of atorvastatin was administered), Group IV (n=12; untreated ovariectomized [OVX] rats and served as a model of osteoporosis [OP]) and Group V (n=12; 20 mg/kg orally of atorvastatin was administered to ovariectomized rats). After 4 weeks, serum acid phosphatase, alkaline phosphatase, osteocalcin, total calcium and inorganic phosphorus were assessed. Then, 3 µm thickness lumbar and femur sections were examined using a light microscope to assess cortical thickness, trabecular area, numbers of osteoblasts and osteoclasts. In the clinical aspect, 85 post-menopausal osteoporotic females with recently detected hyperlipidemia participated in the study. Atorvastatin 40 mg/day, calcium carbonate 500 mg/day and vitamin D 800 international units were given to all patients for a period of 18 months. BMD was measured at the start and at the end of the study by dual-energy X-ray absorptiometry (DEXA). In the experiment aspect, the biomarkers of bone remodeling were notably elevated in the OVX group. Administration of atorvastatin produced a significant decrease in the level of these bone metabolic markers. Atorvastatin significantly ameliorates osteoporotic changes induced by ovariectomy. In the clinical aspect, after 18 months the DEXA showed improvement in the T-score for the three measured zones; however, these changes were statistically significant only in the femoral neck area. Atorvastatin was able to decrease the rate of bone metabolism

The contribution of traditional healers' clinics to public health care system in Addis Ababa, Ethiopia: a cross-sectional study.

PubMed

Birhan, Wubet; Giday, Mirutse; Teklehaymanot, Tilahun

2011-12-02

Ethiopian people have been using traditional medicine since time immemorial with 80% of its population dependent on traditional medicines. However, the documentation of traditional healers' clinics contribution to modern public health system in cosmopolitan cities is scanty. Studies conducted so far are limited and focused on the perceptions and practices of modern and traditional health practitioners about traditional medicine. Thus, a cross sectional study was conducted from February to May 2010 to assess the contribution of traditional healers' clinics to public health care system in Addis Ababa. Ten traditional healers who were willing to participate in the study and 306 patients who were visiting these traditional healers' clinics were interviewed using two types of semi-structured questionnaires. Data were summarized using percentages, tables and bar chart. The diseases mostly treated by traditional healers were wound, inflammation, herpes zoster, hemorrhoids, fracture, paralysis, back-pain, liver diseases, cancer and eczema. This study showed that traditional healers' clinics considerably contribute to public health care in Addis Ababa. Fifty two percent of patients reported that traditional healers' clinics were their first choice when they faced health problems. The reasons for visiting these clinics were 175 (57.2%) efficacy, 109 (35.6%) dissatisfaction with modern medicine, 10 (3.3%) dissatisfaction with modern medicine and efficacy, 6 (2.0%) cost and 6 (2.0%) dissatisfaction and cost. Females (55.2%), young age (20-40 years, 65.0%), never married (56.9%), orthodox (73.9%), Amhara (52.3%), educational status above grade 12 (34.6%) and government employees (29.4%) were frequent visitors. Healers reported that there was no form of cooperation with modern health professionals. The reasons were lack of motivation to collaborate and communicate with modern health service workers. Family based apprenticeship was the sources of knowledge for majority of the

Measurement-based Treatment of Residual Symptoms Using Clinically Useful Depression Outcome Scale: Korean Validation Study

PubMed Central

Jeon, Sang Won; Han, Changsu; Ko, Young-Hoon; Yoon, Seo Young; Pae, Chi-Un; Choi, Joonho; Park, Yong Chon; Kim, Jong-Woo; Yoon, Ho-Kyoung; Ko, Seung-Duk; Patkar, Ashwin A.; Zimmerman, Mark

2017-01-01

Objective This study was aimed at evaluating the diagnostic validity of the Korean version of the Clinically Useful Depression Outcome Scale (CUDOS) with varying follow-up in a typical clinical setting in multiple centers. Methods In total, 891 psychiatric outpatients were enrolled at the time of their intake appointment. Current diagnostic characteristics were examined using the Structured Clinical Interview for DSM-IV (41% major depressive disorder). The CUDOS was measured and compared with three clinician rating scales and four self-report scales. Results The CUDOS showed excellent results for internal consistency (Cronbach’s α, 0.91), test-retest reliability (patients at intake, r=0.81; depressed patients in ongoing treatment, r=0.89), and convergent and discriminant validity (measures of depression, r=0.80; measures of anxiety and somatization, r=0.42). The CUDOS had a high ability to discriminate between different levels of depression severity based on the rating of Clinical Global Impression for depression severity and the diagnostic classification of major depression, minor depression, and non-depression. The ability of the CUDOS to identify patients with major depression was high (area under the receiver operating characteristic curve=0.867). A score of 20 as the optimal cutoff point was suggested when screening for major depression using the CUDOS (sensitivity=89.9%, specificity=69.5%). The CUDOS was sensitive to change after antidepressant treatment: patients with greater improvement showed a greater decrease in CUDOS scores (p<0.001). Conclusion The results of this multi-site outpatient study found that the Korean version of the CUDOS is a very useful measurement for research and for clinical practice. PMID:28138107

Pediatric Allergic Contact Dermatitis: Clinical and Epidemiological Study in a Tertiary Hospital.

PubMed

Ortiz Salvador, J M; Esteve Martínez, A; Subiabre Ferrer, D; Victoria Martínez, A M; de la Cuadra Oyanguren, J; Zaragoza Ninet, V

Few epidemiological studies have investigated the incidence of allergic contact dermatitis in children. Underdiagnosis has been observed in some studies, with many cases in which the condition is not suspected clinically and patch tests are not performed. However, the prevalence of pediatric sensitization to allergens has been reported to be as high as 20%, and the diagnosis should therefore be contemplated as a possibility in this age group. We performed a retrospective analysis of the skin allergy database of the Dermatology Department of Consorcio Hospital General Universitario de Valencia. Children between 0 and 16 years of age diagnosed with allergic contact dermatitis in the previous 15 years (between 2000 and 2015) were included in the analysis. Epidemiological (age, sex, history of atopy) and clinical (site of the lesions, allergen series applied, positive reactions, and their relevance) variables were gathered. Patch tests had been performed on 4,593 patients during the study period. Of these, 265 (6%) were children aged between 0 and 16 years. A positive reaction to at least one of the allergens tested was observed in 144 (54.3%) patients in that group. The allergens most frequently identified were the following (in decreasing order of frequency): thiomersal, cobalt chloride, colophony, paraphenylenediamine, potassium dichromate, mercury, and nickel. The sensitization was considered relevant in 177 (61.3%) cases. More than half of the children studied showed sensitization to 1 or more allergens, with a high percentage of relevant sensitizations. All children with a clinical suspicion of allergic contact dermatitis should be referred for patch testing. As no standardized test series have been developed for this age group, a high level of clinical suspicion and knowledge of the allergens most commonly involved are required when selecting the allergens to be tested. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

Exploitation of prisoners in clinical research: perceptions of study participants

PubMed Central

Christopher, Paul P.; Stein, Michael D.; Johnson, Jennifer E.; Rich, Josiah D.; Friedmann, Peter D.; Clarke, Jennifer G.; Lidz, Charles W.

2015-01-01

This paper discusses findings of a study examining whether prisoners view their participation in clinical research studies as exploitative. Perspectives of seventy prisoners who were enrolled in one of six different clinical studies were analyzed. A minority of participants agreed with statements suggestive of potential exploitation. All but one participant believed that prisoners should have greater access to research. On balance, these data provide reassurance that prisoners in this sample do not view their involvement in clinical research as inappropriately exploitative. PMID:26964404

Reporting of research quality characteristics of studies published in 6 major clinical dental specialty journals.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Madianos, Phoebus; Makou, Margarita; Eliades, Theodore

2011-06-01

The objective of this article was to record reporting characteristics related to study quality of research published in major specialty dental journals with the highest impact factor (Journal of Endodontics, Journal of Oral and Maxillofacial Surgery, American Journal of Orthodontics and Dentofacial Orthopedics; Pediatric Dentistry, Journal of Clinical Periodontology, and International Journal of Prosthetic Dentistry). The included articles were classified into the following 3 broad subject categories: (1) cross-sectional (snap-shot), (2) observational, and (3) interventional. Multinomial logistic regression was conducted for effect estimation using the journal as the response and randomization, sample calculation, confounding discussed, multivariate analysis, effect measurement, and confidence intervals as the explanatory variables. The results showed that cross-sectional studies were the dominant design (55%), whereas observational investigations accounted for 13%, and interventions/clinical trials for 32%. Reporting on quality characteristics was low for all variables: random allocation (15%), sample size calculation (7%), confounding issues/possible confounders (38%), effect measurements (16%), and multivariate analysis (21%). Eighty-four percent of the published articles reported a statistically significant main finding and only 13% presented confidence intervals. The Journal of Clinical Periodontology showed the highest probability of including quality characteristics in reporting results among all dental journals. Copyright © 2011 Elsevier Inc. All rights reserved.

A multicenter study: how do medical students perceive clinical learning climate?

PubMed

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate.

A multicenter study: how do medical students perceive clinical learning climate?

PubMed Central

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

Background The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students’ perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). Results The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students’ interactions in clinical settings, self-realization, mood, students’ intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve

A multicenter study: how do medical students perceive clinical learning climate?

PubMed

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

Background The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). Results The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve

Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study.

PubMed

Prayle, Andrew P; Hurley, Matthew N; Smyth, Alan R

2012-01-03

To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Registry based study of clinical trial summaries. ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year. Selection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009. Proportion of trials for which results had been reported. The ClinicalTrials.gov registry contained 83,579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; χ(2) test, P = 2.6 × 10(-9)). Later phase trials were more likely to report results (P = 4.4 × 10(-11)), as were industry funded trials (P = 2.2 × 10(-16)). Most trials subject to mandatory reporting did not report results within a year of completion.

A Map of Clinical Dermatology Research Centers in Spain: Results of the MaIND Study.

PubMed

Molina-Leyva, A; Descalzo, M A; García-Doval, I

2017-11-01

Bibliometric indicators and analyses of clinical research articles can help to quantify the scientific production of hospitals and institutions and identify their main areas of research. The aim of this study was to draw up a bibliometric map of clinical research in dermatology by Spanish hospitals and institutions through an analysis of quantitative, qualitative, and topic-based variables. Bibliometric study of clinical research articles that met the inclusion criteria and had a definitive publication date between 2005 and 2014 in PubMed or Embase in which the corresponding author's affiliation was a Spanish dermatology department or institution. Barcelona and Madrid were the provinces with the highest number of articles and citations. The centers with the most articles and citations were Hospital Clínic and Instituto Valenciano de Oncología. Those 2 hospitals also produced the highest number of articles on the most common research topic identified: melanoma. Because the articles were selected on the basis of the affiliation of the corresponding author to a Spanish dermatology center, this analysis does not include collaborative studies or clinical research studies led by nondermatology centers. We have created a bibliometric map of clinical dermatology research in Spain that shows the distribution of scientific production and the main areas of research by province and hospital/institution. This map could be useful for education and research purposes. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

Medicinal Mushrooms in Human Clinical Studies. Part I. Anticancer, Oncoimmunological, and Immunomodulatory Activities: A Review.

PubMed

Wasser, Solomon P

2017-01-01

More than 130 medicinal functions are thought to be produced by medicinal mushrooms (MMs) and fungi, including antitumor, immunomodulating, antioxidant, radical scavenging, cardiovascular, antihypercholesterolemic, antiviral, antibacterial, antiparasitic, antifungal, detoxification, hepatoprotective, antidiabetic, and other effects. Many, if not all, higher Basidiomycetes mushrooms contain biologically active compounds in fruit bodies, cultured mycelia, and cultured broth. Special attention has been paid to mushroom polysaccharides. Numerous bioactive polysaccharides or polysaccharide-protein complexes from MMs seem to enhance innate and cell-mediated immune responses, and they exhibit antitumor activities in animals and humans. While the mechanism of their antitumor actions is still not completely understood, stimulation and modulation of key host immune responses by these mushroom compounds seems to be central. Most important for modern medicine are polysaccharides and low-molecular weight secondary metabolites with antitumor and immunostimulating properties. More than 600 studies have been conducted worldwide, and numerous human clinical trials on MMs have been published. Several of the mushroom compounds have proceeded through phase I, II, and III clinical studies and are used extensively and successfully in Asia to treat various cancers and other diseases. The aim of this review is to provide an overview of and analyze the literature on clinical trials using MMs with human anticancer, oncoimmunological, and immunomodulatory activities. High-quality, long-term, randomized, double-blind, placebo-controlled clinical studies of MMs, including well-sized population studies are definitely needed in order to yield statistical power showing their efficacy and safety. Clinical trials must obtain sufficient data on the efficacy and safety of MM-derived drugs and preparations. Discussion of results based on clinical studies of the anticancer, oncoimmunological, and

Clinical trial shows safety and effectiveness of new combination immunotherapy for advanced liver cancer | Center for Cancer Research

Cancer.gov

A recently completed phase I clinical trial at the NIH Clinical Center in Bethesda, Maryland, demonstrates that a combination of two immunotherapy drugs to target hepatocellular carcinoma (HCC) was well-tolerated and shrunk tumors in a larger percentage of patients than the standard monotherapy.  Read more...

Analysis of Published Criteria for Clinically Inactive Disease in a Large Juvenile Dermatomyositis Cohort Shows That Skin Disease Is Underestimated

PubMed Central

Almeida, Beverley; Campanilho‐Marques, Raquel; Arnold, Katie; Pilkington, Clarissa A.; Wedderburn, Lucy R.; Armon, Kate; Briggs, Vanja; Ellis‐Gage, Joe; Roper, Holly; Watts, Joanna; Baildam, Eileen; Hanna, Louise; Lloyd, Olivia; McCann, Liza; Roberts, Ian; McGovern, Ann; Riley, Phil; Al‐Abadi, Eslam; Ryder, Clive; Scott, Janis; Southwood, Taunton; Thomas, Beverley; Amin, Tania; Burton, Deborah; Jackson, Gillian; Van Rooyen, Vanessa; Wood, Mark; Wyatt, Sue; Browne, Michael; Davidson, Joyce; Ferguson, Sue; Gardner‐Medwin, Janet; Martin, Neil; Waxman, Liz; Foster, Helen; Friswell, Mark; Jandial, Sharmila; Qiao, Lisa; Sen, Ethan; Smith, Eve; Stevenson, Vicky; Swift, Alison; Wade, Debbie; Watson, Stuart; Crate, Lindsay; Frost, Anna; Jordan, Mary; Mosley, Ellen; Satyapal, Rangaraj; Stretton, Elizabeth; Venning, Helen; Warrier, Kishore; Almeida, Beverley; Arnold, Katie; Beard, Laura; Brown, Virginia; Campanilho‐Marques, Raquel; Enayat, Elli; Glackin, Yvonne; Halkon, Elizabeth; Hasson, Nathan; Juggins, Audrey; Kassoumeri, Laura; Lunt, Sian; Maillard, Sue; Nistala, Kiran; Pilkington, Clarissa; Simou, Stephanie; Smith, Sally; Varsani, Hemlata; Wedderburn, Lucy; Murray, Kevin; Ioannou, John; Suffield, Linda; Al‐Obaidi, Muthana; Leach, Sam; Lee, Helen; Smith, Helen; Inness, Emma; Kendall, Eunice; Mayers, David; Wilkinson, Nick; Clinch, Jacqui; Pluess‐Hall, Helen

2015-01-01

Objective The Pediatric Rheumatology International Trials Organisation (PRINTO) recently published criteria for classification of patients with juvenile dermatomyositis (DM) as having clinically inactive disease. The criteria require that at least 3 of 4 conditions be met, i.e., creatine kinase level ≤150 units/liter, Childhood Myositis Assessment Scale score ≥48, Manual Muscle Testing in 8 muscles score ≥78, and physician's global assessment of overall disease activity (PGA) ≤0.2. The present study was undertaken to test these criteria in a UK cohort of patients with juvenile DM. Methods We assessed 1,114 patient visits for the 4 items in the PRINTO criteria for clinically inactive disease. Each visit was analyzed to determine whether skin disease was present. The Disease Activity Score (DAS) for juvenile DM was determined in 59 patients. Results At 307 of the 1,114 visits, clinically inactive disease was achieved based on the 3 muscle criteria (but with a PGA of >0.2); rash was present at 65.8% of these visits and nailfold capillary abnormalities at 35.2%. When PGA ≤0.2 was one of the 3 criteria that were met, the frequency of skin signs was significantly lower (rash in 23.1% and nailfold capillary abnormalities in 8.7%). If PGA was considered an essential criterion for clinically inactive disease (P‐CID), patients with active skin disease were less likely to be categorized as having clinically inactive disease (a median DAS skin score of 0 [of a possible maximum of 9] in visits where the PGA was ≤0.2, versus a median DAS skin score of 4 in patients meeting the 3 muscle criteria [with a PGA of >0.2]; P < 0.001). Use of the P‐CID led to improvements in the positive predictive value and the positive likelihood ratio (85.4% and 11.0, respectively, compared to 72.9% and 5.1 with the current criteria). Conclusion There was a high frequency of skin disease among patients with juvenile DM who did not meet the PGA criterion for inactive disease but met

Nurses' Lived Experience of Working with Nursing Students in Clinical Wards: a Phenomenological Study

PubMed Central

Parvan, Kobra; Shahbazi, Shahla; Ebrahimi, Hossein; Valizadeh, Susan; Rahmani, Azad; Jabbarzadeh Tabrizi, Faranak; Esmaili, Fariba

2018-01-01

Introduction: Despite being aware of the importance of nurses’ role in providing clinical training to nursing students, studies show that sufficient research has not yet been conducted on the experience of clinical nurses who are engaged in training nursing students outside their normal working hours. The present study aim to describe the experience of these nurses who are training outside their routine working hours. Methods: This study was conducted using descriptive-phenomenology method. Twelve nurses was participated in this research. Data were collected using purposive sampling method and face to face interviews based on nurses’ real life experience of students’ learning in clinical settings through answering open-ended questions. Spiegel burg analysis method was used to analyze the data. Results: The result of data analysis was the derivation of four themes and eight sub-themes. Themes included "nurses as teaching sources", "changes in the balance of doing routine tasks", "professional enthusiasm", and "nurses as students' professional socialization source of inspiration". Sub-themes included "efficient education", "poor education", "support", "interference in the role," "self-efficacy development", "inner satisfaction", "positive imaging" and "being a model". Conclusion: It is necessary that academic centers plan for teaching nurses working on a contractual basis in the field of the evaluation method and various methods of teaching. The findings also suggested the development of individual self-efficacy in clinical nurses who train students. PMID:29637056

The use of clinical contrast media for lymphangiography in cadaveric studies.

PubMed

Pan, Wei-Ren; Le Roux, Cara Michelle; Rozen, Warren M

2009-01-01

Radiographic contrast media have not been previously used in human lymphatic cadaver studies. As these will have further clinical applications, we sought to investigate their use in this role. Both lower legs from an unembalmed human cadaver were studied. We used hydrogen peroxide to identify the lymphatics of the dorsum of the foot, and a single lymphatic was microsurgically injected with 1 ml of 76% 'Urografin.' A series of radiographs were taken 1 min after injection and for 2.5 h until the Urografin vanished. Images were digitalized for analysis. The series of lymphangiograms generated showed the size, location, and course of the lymphatics in the leg. Over time, the density of the iodinated contrast in the lymphatic vessels reduced and disappeared completely after 2.5 hours postinjection. A 'digitally subtracted' image provided a clear and high-contrast lymphangiogram. The lymphatic network identified was shown to diverge and converge twice as it coursed proximally up the limb. Urografin, a clinical radiographic contrast medium, was shown to lose contrast density 2.5 h following cadaveric intralymphatic injection. The use of a new technique, that of 'digital subtraction lymphangiography,' was able to demonstrate the lymphatic vessel pathways clearly, and is a useful technique for cadaveric lymphatic studies.

Antiasthmatic activity of Moringa oleifera Lam: A clinical study

PubMed Central

Agrawal, Babita; Mehta, Anita

2008-01-01

The present study was carried out to investigate the efficacy and safety of seed kernels of Moringa oleifera in the treatment of bronchial asthma. Twenty patients of either sex with mild-to-moderate asthma were given finely powdered dried seed kernels in dose of 3 g for 3 weeks. The clinical efficacy with respect to symptoms and respiratory functions were assessed using a spirometer prior to and at the end of the treatment. Hematological parameters were not changed markedly by treatment with M. oleifera. However, the majority of patients showed a significant increase in hemoglobin (Hb) values and Erythrocyte sedimentation rate (ESR) was significantly reduced. Significant improvement was also observed in symptom score and severity of asthmatic attacks. Treatment with the drug for 3 weeks produced significant improvement in forced vital capacity, forced expiratory volume in one second, and peak expiratory flow rate values by 32.97 ± 6.03%, 30.05 ± 8.12%, and 32.09 ± 11.75%, respectively, in asthmatic subjects. Improvement was also observed in % predicted values. None of the patients showed any adverse effects with M. oleifera. The results of the present study suggest the usefulness of M. oleifera seed kernel in patients of bronchial asthma. PMID:21264158

[Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

PubMed

Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

2015-11-01

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

Clinical and microbiologic study of periodontitis associated with Kindler syndrome.

PubMed

Wiebe, Colin B; Penagos, Homero; Luong, Nancy; Slots, Jørgen; Epstein, Ervin; Siegel, Dawn; Häkkinen, Lari; Putnins, Edward E; Larjava, Hannu S

2003-01-01

Little is known about the onset and prevalence of periodontal disease in patients with the rare Kindler syndrome, a genodermatological disorder. This study investigated the level of clinical periodontal attachment in relation to age and presence of putative periodontopathogenic bacteria in individuals with Kindler syndrome. Eighteen individuals diagnosed with Kindler syndrome and 13 control subjects, aged 4 to 37 years, from rural Panama received a limited clinical periodontal examination. Subgingival samples were collected for identification of putative periodontal pathogens by polymerase chain reaction. Mild to severe gingivitis was a common finding in all adults of the study population. Seventy-two percent (13/18) of the Kindler patients and 46% (6/13) of the control subjects showed mild to severe periodontal disease (P = 0.001, chi-square test). The onset of periodontitis was earlier and the progression occurred at a faster rate in the Kindler group. There was a strong correlation (r = 0.83) between the level of attachment loss and age in the Kindler group and a weaker correlation (r = 0.66) in the control group. The appearance of gingival tissues suggested atypical periodontitis with spontaneous bleeding and fragile, often desquamative, gingiva. In periodontitis patients, Porphyromonas gingivallis and Diallster pneumosintes tended to occur more frequently in control individuals compared to those with Kindler syndrome. In the Kindler group, periodontitis had an onset in early teenage years and progressed more rapidly compared to non-Kindler individuals of the same geographic and ethnic group. Clinical and microbiological findings suggest atypical periodontitis in Kindler patients. We propose to include Kindler syndrome in the category of medical disorders predisposing to destructive periodontal disease.

Understanding Study Participants Views on Co-Creation of Data and Use of EHR in Clinical Studies.

PubMed

Scott Duncan, Therese; Hägglund, Maria

2018-01-01

In order to increase clinical trial participation, the reasons for participating need to be observed. Since there is rather inadequate information concerning how individuals such as patients, decides to participate in clinical trials semi-structured interviews have been done. Examining the use of EHR in clinical trials and co-creation of data, the result showed that it is important for the researches to have access to the patients' EHR and for the patients to contribute with their own ideas of research. Important aspects of further participation in clinical trials were that it should be fun and informative. The patients agreed on that the effort of participating could decrease with the use of electronically collection and self-reporting of data, e.g. through a patient portal.

Asking good clinical research questions and choosing the right study design.

PubMed

Bragge, P

2010-07-01

Clinicians and researchers seek answers to clinical research questions, primarily by accessing the results of clinical research studies. This paper moves the focus of research enquiry from getting answers to developing good clinical research questions. Using worked examples, the steps involved in refining questions drawn from various sources to create 'answerable' clinical research questions using the 'PICO' principle are described. Issues to consider in prioritising clinical research questions are also identified. Theoretical and practical considerations involved in choosing the right study design for a clinical research question are then discussed using the worked examples. These include: Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Adolescent health--a descriptive study of a school doctor clinic.

PubMed

Chavasse, M; North, D; McAvoy, B

1995-07-14

To describe a school doctor clinic at a New Zealand secondary school. A three phase study was designed and conducted at a coeducational secondary school in Auckland. Firstly, a health questionnaire was developed to assess adolescents' perceptions of their health status and use of primary health care services. The second phase was descriptive study of a newly established school doctor clinic. The doctor clinic was run twice weekly over a 3 month period in 1993. The third phase of the study was a clinic-based satisfaction survey. A 75% response rate was achieved, with a total of 221 health questionnaires completed from 292. Although the majority of students (n = 184, 84%) considered themselves healthy, 16% (n = 36) described their health as only 'fair' or 'poor'. Seventy one percent (n = 157) of students had seen their general practitioner in the preceeding twelve months. Thirteen percent (n = 142) of the school population consulted the school doctor clinic. Significantly more female, Maori and European students attended the school doctor clinic compared with the school demography. The commonest diagnoses for the doctor clinic were respiratory, skin and musculoskeletal problems. Thirty one percent of the diagnoses related to recognised adolescent health needs such as contraception, sexual health, nutrition, and psychosocial problems. Over two thirds of students at the first consultation had not seen another health provider. Students perceived that the doctor clinic overcame barriers such as access, cost and confidentiality. The school doctor clinic was well utilised, overcame some barriers to access and addressed many recognised adolescent health needs.

Case Study: Applying OpenEHR Archetypes to a Clinical Data Repository in a Chinese Hospital.

PubMed

Min, Lingtong; Wang, Li; Lu, Xudong; Duan, Huilong

2015-01-01

openEHR is a flexible and scalable modeling methodology for clinical information and has been widely adopted in Europe and Australia. Due to the reasons of differences in clinical process and management, there are few research projects involving openEHR in China. To investigate the feasibility of openEHR methodology for clinical information modelling in China, this paper carries out a case study to apply openEHR archetypes to Clinical Data Repository (CDR) in a Chinese hospital. The results show that a set of 26 archetypes are found to cover all the concepts used in the CDR. Of all these, 9 (34.6%) are reused without change, 10 are modified and/or extended, and 7 are newly defined. The reasons for modification, extension and newly definition have been discussed, including granularity of archetype, metadata-level versus data-level modelling, and the representation of relationships between archetypes.

Clinical studies on chromium picolinate supplementation in diabetes mellitus--a review.

PubMed

Broadhurst, C Leigh; Domenico, Philip

2006-12-01

Chromium (Cr) picolinate (CrPic) is a widely used nutritional supplement for optimal insulin function. A relationship among Cr status, diabetes, and associated pathologies has been established. Virtually all trials using CrPic supplementation for subjects with diabetes have demonstrated beneficial effects. Thirteen of 15 clinical studies (including 11 randomized, controlled studies) involving a total of 1,690 subjects (1,505 in CrPic group) reported significant improvement in at least one outcome of glycemic control. All 15 studies showed salutary effects in at least one parameter of diabetes management, including dyslipidemia. Positive outcomes from CrPic supplementation included reduced blood glucose, insulin, cholesterol, and triglyceride levels and reduced requirements for hypoglycemic medication. The greater bioavailability of CrPic compared with other forms of Cr (e.g., niacin-bound Cr or CrCl(3)) may explain its comparatively superior efficacy in glycemic and lipidemic control. The pooled data from studies using CrPic supplementation for type 2 diabetes mellitus subjects show substantial reductions in hyperglycemia and hyperinsulinemia, which equate to a reduced risk for disease complications. Collectively, the data support the safety and therapeutic value of CrPic for the management of cholesterolemia and hyperglycemia in subjects with diabetes.

The Nun Study: risk factors for pathology and clinical-pathologic correlations.

PubMed

Mortimer, James A

2012-07-01

The Nun Study was the first cohort study to enroll and follow a large, well-defined population that included demented and non-demented participants, all of whom agreed to donate their brains for research. The inclusion of systematic neuropathologic analysis in this study has resulted in a greater understanding of the role of Alzheimer and vascular pathology in the expression of memory deficits and dementia and has provided data showing that biomarkers for the pathology may be evident many decades earlier in adult life. Findings related to neuropathology in this study have included the following: (1) Although clinical outcomes were strongly correlated with Alzheimer neuropathology, about one-third of the participants fulfilling criteria for neuropathologic Alzheimer's disease (AD) were not demented at the time of death. (2) Brain infarcts by themselves had little effect on cognitive status, but played an important role in increasing the risk of dementia associated with Alzheimer pathology. (3) Hippocampal volume was strongly correlated with Braak neurofibrillary stage even in participants with normal cognitive function. (4) A linguistic characteristic of essays written in early adult life, idea density, had a strong association with not only clinical outcomes in late life, but the severity of Alzheimer neuropathology as well. (5) The effect of apolipoprotein E-e4 on dementia was mediated through Alzheimer, but not vascular pathology.

Clinical nurse leaders' and academics' perspectives in clinical assessment of final-year nursing students: A qualitative study.

PubMed

Wu, Xi Vivien; Enskär, Karin; Pua, Lay Hoon; Heng, Doreen Gek Noi; Wang, Wenru

2017-09-01

The nature of nursing practice is diverse; therefore, clinical assessment is a complex process. This study explores the perceptions of clinical nurse leaders and academics on clinical assessment for undergraduate nursing education during transition to practice. An explorative qualitative approach was applied. Eight nurse managers, six clinical nurse educators, and eight academics from two tertiary hospitals and a university in Singapore participated in four focus group discussions. Thematic analysis was conducted. Four overriding themes were revealed: the need for a valid and reliable clinical assessment tool, preceptors' competency in clinical assessment, challenges encountered by the students in clinical assessment, and the need for close academic and clinical collaboration to support preceptors and students. Closer academic-clinical partnership is recommended to review the clinical education curriculum. Clinical and educational institutions need to work closely to design a learning program to enhance preceptors' competence in clinical pedagogy and assessment. Furthermore, a stress management program could build students' resiliency in coping with unfamiliar clinical environments. Ongoing support needs to be provided for both preceptors and students to enrich the preceptorship and learning experiences. © 2017 John Wiley & Sons Australia, Ltd.

Nerve ultrasound shows subclinical peripheral nerve involvement in neurofibromatosis type 2.

PubMed

Telleman, Johan A; Stellingwerff, Menno D; Brekelmans, Geert J; Visser, Leo H

2018-02-01

Neurofibromatosis type 2 (NF2) is mainly associated with central nervous system (CNS) tumors. Peripheral nerve involvement is described in symptomatic patients, but evidence of subclinical peripheral nerve involvement is scarce. We conducted a cross-sectional pilot study in 2 asymptomatic and 3 minimally symptomatic patients with NF2 to detect subclinical peripheral nerve involvement. Patients underwent clinical examination, nerve conduction studies (NCS), and high-resolution ultrasonography (HRUS). A total of 30 schwannomas were found, divided over 20 nerve segments (33.9% of all investigated nerve segments). All patients had at least 1 schwannoma. Schwannomas were identified with HRUS in 37% of clinically unaffected nerve segments and 50% of nerve segments with normal NCS findings. HRUS shows frequent subclinical peripheral nerve involvement in NF2. Clinicians should consider peripheral nerve involvement as a cause of weakness and sensory loss in the extremities in patients with this disease. Muscle Nerve 57: 312-316, 2018. © 2017 Wiley Periodicals, Inc.

Development of the quantitative indicator of abdominal examination for clinical application: a pilot study.

PubMed

Ko, Seok-Jae; Lee, Hyunju; Kim, Seul-Ki; Kim, Minji; Kim, Jinsung; Lee, Beom-Joon; Park, Jae-Woo

2015-06-01

Abdominal examination (AE) is the evaluation of the status of illness by examining the abdominal region in traditional Korean medicine (TKM). Although AE is currently considered an important diagnostic method in TKM, owing to its clinical usage, no studies have been conducted to objectively assess its accuracy and develop standards. Twelve healthy subjects and 21 patients with functional dyspepsia have participated in this study. The patients were classified into epigastric discomfort group (n=11) and epigastric discomfort with tenderness group (n=10) according to the clinical diagnosis by AE. After evaluating the subjective epigastric discomfort in all subjects, two independent clinicians measured the pressure pain threshold (PPT) two times at an acupoint (CV 14) using an algometer. We then assessed the interrater and intrarater reliability of the PPT measurements and evaluated the validity (sensitivity and specificity) via a receiver operating characteristic plot and optimal cutoff value. The results of the interrater reliability test showed a very strong correlation (correlation coefficient range: 0.82-0.91). The results of intrarater reliability test also showed a higher than average correlation (intraclass correlation coefficient: 0.58-0.70). The optimal cutoff value of PPT in the epigastric area was 1.8 kg/cm(2) with 100% sensitivity and 54.54% specificity. PPT measurements in the epigastric area with an algometer demonstrated high reliability and validity for AE, which makes this approach potentially useful in clinical applications as a new quantitative measurement in TKM.

Automatic recognition of disorders, findings, pharmaceuticals and body structures from clinical text: an annotation and machine learning study.

PubMed

Skeppstedt, Maria; Kvist, Maria; Nilsson, Gunnar H; Dalianis, Hercules

2014-06-01

Automatic recognition of clinical entities in the narrative text of health records is useful for constructing applications for documentation of patient care, as well as for secondary usage in the form of medical knowledge extraction. There are a number of named entity recognition studies on English clinical text, but less work has been carried out on clinical text in other languages. This study was performed on Swedish health records, and focused on four entities that are highly relevant for constructing a patient overview and for medical hypothesis generation, namely the entities: Disorder, Finding, Pharmaceutical Drug and Body Structure. The study had two aims: to explore how well named entity recognition methods previously applied to English clinical text perform on similar texts written in Swedish; and to evaluate whether it is meaningful to divide the more general category Medical Problem, which has been used in a number of previous studies, into the two more granular entities, Disorder and Finding. Clinical notes from a Swedish internal medicine emergency unit were annotated for the four selected entity categories, and the inter-annotator agreement between two pairs of annotators was measured, resulting in an average F-score of 0.79 for Disorder, 0.66 for Finding, 0.90 for Pharmaceutical Drug and 0.80 for Body Structure. A subset of the developed corpus was thereafter used for finding suitable features for training a conditional random fields model. Finally, a new model was trained on this subset, using the best features and settings, and its ability to generalise to held-out data was evaluated. This final model obtained an F-score of 0.81 for Disorder, 0.69 for Finding, 0.88 for Pharmaceutical Drug, 0.85 for Body Structure and 0.78 for the combined category Disorder+Finding. The obtained results, which are in line with or slightly lower than those for similar studies on English clinical text, many of them conducted using a larger training data set, show that

Retrieval of diagnostic and treatment studies for clinical use through PubMed and PubMed's Clinical Queries filters.

PubMed

Lokker, Cynthia; Haynes, R Brian; Wilczynski, Nancy L; McKibbon, K Ann; Walter, Stephen D

2011-01-01

Clinical Queries filters were developed to improve the retrieval of high-quality studies in searches on clinical matters. The study objective was to determine the yield of relevant citations and physician satisfaction while searching for diagnostic and treatment studies using the Clinical Queries page of PubMed compared with searching PubMed without these filters. Forty practicing physicians, presented with standardized treatment and diagnosis questions and one question of their choosing, entered search terms which were processed in a random, blinded fashion through PubMed alone and PubMed Clinical Queries. Participants rated search retrievals for applicability to the question at hand and satisfaction. For treatment, the primary outcome of retrieval of relevant articles was not significantly different between the groups, but a higher proportion of articles from the Clinical Queries searches met methodologic criteria (p=0.049), and more articles were published in core internal medicine journals (p=0.056). For diagnosis, the filtered results returned more relevant articles (p=0.031) and fewer irrelevant articles (overall retrieval less, p=0.023); participants needed to screen fewer articles before arriving at the first relevant citation (p<0.05). Relevance was also influenced by content terms used by participants in searching. Participants varied greatly in their search performance. Clinical Queries filtered searches returned more high-quality studies, though the retrieval of relevant articles was only statistically different between the groups for diagnosis questions. Retrieving clinically important research studies from Medline is a challenging task for physicians. Methodological search filters can improve search retrieval.

[Comparative clinical study of 2 surgical techniques for trapeziometacarpal osteoarthritis].

PubMed

Martínez-Martínez, F; García-Hortelano, S; García-Paños, J P; Moreno-Fernández, J M; Martín-Ferrero, M Á

2016-01-01

In trapeziometacarpal osteoarthritis (or rhizarthrosis), there is great controversy over the surgical technique to choose: simple trapeziectomy, resection-interposition arthroplasty, interposition arthroplasty suspension-or arthroplasty with implant or prosthesis. These latter 2 are the most used without consensus in the literature on the technique to choose and without sufficient comparative studies. The objective is to compare the 2 techniques most used today: suspension-interposition arthroplasty and arthroplasty with prosthesis. A prospective study was conducted on 15 patients diagnosed with grade 2-3 rhizarthrosis treated with interposition arthroplasty-suspension (group 1) and 15 with prosthesis (group 2) showing clinical outcomes, advantages and disadvantages of each. The study variables were the visual analogue scale (VAS), the DASH questionnaire, the grip strength, the strength of end to end and end-lateral clamp, the joint balance adduction-abduction and preemption-retropositioning, and the opposition. The 2 groups are from 2 different hospitals operated on by a hand surgeon from the Hand Unit. The follow-up time for all patients included in the study was 12 months. The VAS, DASH and grip strength at 12 months did not show significant differences. As regards the strength of end to end and end-lateral clamp, group 2 showed the highest values in all follow-up periods with statistically significant differences. Patient selection and surgical experience is essential, given the satisfactory results of both techniques. Arthroplasty prosthesis is reserved for grades 2 and 3, middle-aged patients, good trapezium architecture, and experienced surgeons. Copyright © 2014 SECOT. Published by Elsevier Espana. All rights reserved.

Movement-related beta oscillations show high intra-individual reliability.

PubMed

Espenhahn, Svenja; de Berker, Archy O; van Wijk, Bernadette C M; Rossiter, Holly E; Ward, Nick S

2017-02-15

Oscillatory activity in the beta frequency range (15-30Hz) recorded from human sensorimotor cortex is of increasing interest as a putative biomarker of motor system function and dysfunction. Despite its increasing use in basic and clinical research, surprisingly little is known about the test-retest reliability of spectral power and peak frequency measures of beta oscillatory signals from sensorimotor cortex. Establishing that these beta measures are stable over time in healthy populations is a necessary precursor to their use in the clinic. Here, we used scalp electroencephalography (EEG) to evaluate intra-individual reliability of beta-band oscillations over six sessions, focusing on changes in beta activity during movement (Movement-Related Beta Desynchronization, MRBD) and after movement termination (Post-Movement Beta Rebound, PMBR). Subjects performed visually-cued unimanual wrist flexion and extension. We assessed Intraclass Correlation Coefficients (ICC) and between-session correlations for spectral power and peak frequency measures of movement-related and resting beta activity. Movement-related and resting beta power from both sensorimotor cortices was highly reliable across sessions. Resting beta power yielded highest reliability (average ICC=0.903), followed by MRBD (average ICC=0.886) and PMBR (average ICC=0.663). Notably, peak frequency measures yielded lower ICC values compared to the assessment of spectral power, particularly for movement-related beta activity (ICC=0.386-0.402). Our data highlight that power measures of movement-related beta oscillations are highly reliable, while corresponding peak frequency measures show greater intra-individual variability across sessions. Importantly, our finding that beta power estimates show high intra-individual reliability over time serves to validate the notion that these measures reflect meaningful individual differences that can be utilised in basic research and clinical studies. Copyright © 2016 The

Sharing Patient-Generated Data in Clinical Practices: An Interview Study.

PubMed

Zhu, Haining; Colgan, Joanna; Reddy, Madhu; Choe, Eun Kyoung

2016-01-01

Patients are tracking and generating an increasingly large volume of personal health data outside the clinic due to an explosion of wearable sensing and mobile health (mHealth) apps. The potential usefulness of these data is enormous as they can provide good measures of everyday behavior and lifestyle. However, how we can fully leverage patient-generated data (PGD) and integrate them in clinical practice is less clear. In this interview study, we aim to understand how patients and clinicians currently share patient-generated data in clinical care practice. From the study, we identified technical, social, and organizational challenges in sharing and fully leveraging patient-generated data in clinical practices. Our findings can provide researchers potential avenues for enablers and barriers in sharing patient-generated data in clinical settings.

What to do with thyroid nodules showing benign cytology and BRAF(V600E) mutation? A study based on clinical and radiologic features using a highly sensitive analytic method.

PubMed

Kim, Soo-Yeon; Kim, Eun-Kyung; Kwak, Jin Young; Moon, Hee Jung; Yoon, Jung Hyun

2015-02-01

BRAF(V600E) mutation analysis has been used as a complementary diagnostic tool to ultrasonography-guided, fine-needle aspiration (US-FNA) in the diagnosis of thyroid nodule with high specificity reported up to 100%. When highly sensitive analytic methods are used, however, false-positive results of BRAF(V600E) mutation analysis have been reported. In this study, we investigated the clinical, US features, and outcome of patients with thyroid nodules with benign cytology but positive BRAF(V600E) mutation using highly sensitive analytic methods from US-FNA. This study included 22 nodules in 22 patients (3 men, 19 women; mean age, 53 years) with benign cytology but positive BRAF(V600E) mutation from US-FNA. US features were categorized according to the internal components, echogenicity, margin, calcifications, and shape. Suspicious US features included markedly hypoechogenicity, noncircumscribed margins, micro or mixed calcifications, and nonparallel shape. Nodules were considered to have either concordant or discordant US features to benign cytology. Medical records and imaging studies were reviewed for final cytopathology results and outcomes during follow-up. Among the 22 nodules, 17 nodules were reviewed. Fifteen of 17 nodules were malignant, and 2 were benign. The benign nodules were confirmed as adenomatous hyperplasia with underlying lymphocytic thyroiditis and a fibrotic nodule with dense calcification. Thirteen of the 15 malignant nodules had 2 or more suspicious US features, and all 15 nodules were considered to have discordant cytology considering suspicious US features. Five nodules had been followed with US or US-FNA without resection, and did not show change in size or US features on follow-up US examinations. BRAF(V600E) mutation analysis is a highly sensitive diagnostic tool in the diagnosis of papillary thyroid carcinomas. In the management of thyroid nodules with benign cytology but positive BRAF(V600E) mutation, thyroidectomy should be considered in

Retrospective study of clinical and hematological aspects associated with dogs naturally infected by Hepatozoon canis in Ludhiana, Punjab, India

PubMed Central

Chhabra, Sushma; Uppal, Sanjeev Kumar; Singla, Lachhman Das

2013-01-01

Objective To evaluate clinical and hematological aspects of dogs naturally infected with Hepatozoon canis (H. canis) presented at the Small Animal Clinics of Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana. Methods Blood films of 34 naturally infected dogs were examined for haematological alterations and parasitaemia. Signalment and clinical signs were recorded from the animals. Clinical histories were filled out during the consultation. Results Of the 34 positive dogs by Giemsa stained peripheral blood films, 88.23% presented parasitaemia by H. canis only, while 11.77% had the combination of H. canis, Babesia sp. and Ehrlichia sp. Young male dogs less than one-year-old, of non-descript breed, were the most commonly affected. And 26.47% were presented with anorexia/inappetence as the only clinical symptom. Other clinical symptoms were mild to moderate fever, pale mucosae and lethargy; a few were also showing the signs of vomiting and diarrhoea. Haematological alterations showed mainly normochromic-normocytic anaemia, leukocytosis and neutrophilia. Conclusions The findings of this study substantiate that H. canis caused clinical and haematological alterations of the varied intensity in dogs, even with low parasitaemia, should be taken into consideration. PMID:23730562

Retrospective study of clinical and hematological aspects associated with dogs naturally infected by Hepatozoon canis in Ludhiana, Punjab, India.

PubMed

Chhabra, Sushma; Uppal, Sanjeev Kumar; Singla, Lachhman Das

2013-06-01

To evaluate clinical and hematological aspects of dogs naturally infected with Hepatozoon canis (H. canis) presented at the Small Animal Clinics of Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana. Blood films of 34 naturally infected dogs were examined for haematological alterations and parasitaemia. Signalment and clinical signs were recorded from the animals. Clinical histories were filled out during the consultation. Of the 34 positive dogs by Giemsa stained peripheral blood films, 88.23% presented parasitaemia by H. canis only, while 11.77% had the combination of H. canis, Babesia sp. and Ehrlichia sp. Young male dogs less than one-year-old, of non-descript breed, were the most commonly affected. And 26.47% were presented with anorexia/inappetence as the only clinical symptom. Other clinical symptoms were mild to moderate fever, pale mucosae and lethargy; a few were also showing the signs of vomiting and diarrhoea. Haematological alterations showed mainly normochromic-normocytic anaemia, leukocytosis and neutrophilia. The findings of this study substantiate that H. canis caused clinical and haematological alterations of the varied intensity in dogs, even with low parasitaemia, should be taken into consideration.

Clinical and computerized evaluation in study of temporo-mandibular joint intracapsular disease.

PubMed

Ciavarella, D; Mastrovincenzo, M; Sabatucci, A; Parziale, V; Granatelli, F; Violante, F; Bossù, M; Lo Muzio, L; Chimenti, C

2010-03-01

In this work authors show a diagnostic criteria in study of TMID: neuro occlusal clinical evaluation (NOE), T-Scan 2 system and surface electromyography (sEMG). Nine patients 25-30 years old with TMID problem and 9 healthy group control have been selected and examined. On each patients it has been performed NOE, T-Scan and sEMG test. NOE has been calculated on each patient photos lateral mandibular excursion angle called: masticatory functional angle (AFM). T-Scan System is a computerized occlusal analyzer that provide in-depth understanding of the overall balance of the occlusion. At the same time of T-Scan record sEMG tests, in resting position and in maximum clench, have been performed. In healthy control there were no AFM difference. In no healthy group there were difference between the two AFM greater than 6 degrees. T-Scan COF showed how in healthy group control there was never a difference of COF greater than 5%. In no healthy group the difference were greater than 5% P<0.05. T-scan showed difference of time force in maximum intercuspidation (MIFT) in healthy respect TMID patients. In healthy patients MIFT was higher than TMID patients P<0.05. sEMG test showed in non healthy group a great asymmetrical activation of masseter (MM). MM activation were greater on side affected by joint sound than the balance side P<0.001. sEMG show how in TMID patients maximum masseter activation is always lower than maximum masseter activation of healthy subjects P<0.001. Neuro occlusal clinical evaluation (NOE) in TMID patients is supported by instrumental evaluation.

Preliminary clinical nursing leadership competency model: a qualitative study from Thailand.

PubMed

Supamanee, Treeyaphan; Krairiksh, Marisa; Singhakhumfu, Laddawan; Turale, Sue

2011-12-01

This qualitative study explored the clinical nursing leadership competency perspectives of Thai nurses working in a university hospital. To collect data, in-depth interviews were undertaken with 23 nurse administrators, and focus groups were used with 31 registered nurses. Data were analyzed using content analysis, and theory development was guided by the Iceberg model. Nurses' clinical leadership competencies emerged, comprising hidden characteristics and surface characteristics. The hidden characteristics composed three elements: motive (respect from the nursing and healthcare team and being secure in life), self-concept (representing positive attitudes and values), and traits (personal qualities necessary for leadership). The surface characteristics comprised specific knowledge of nurse leaders about clinical leadership, management and nursing informatics, and clinical skills, such as coordination, effective communication, problem solving, and clinical decision-making. The study findings help nursing to gain greater knowledge of the essence of clinical nursing leadership competencies, a matter critical for theory development in leadership. This study's results later led to the instigation of a training program for registered nurse leaders at the study site, and the formation of a preliminary clinical nursing leadership competency model. © 2011 Blackwell Publishing Asia Pty Ltd.

Exploring Factors Affecting Undergraduate Medical Students' Study Strategies in the Clinical Years: A Qualitative Study

ERIC Educational Resources Information Center

Al Kadri, Hanan M. F.; Al-Moamary, Mohamed S.; Elzubair, Margaret; Magzoub, Mohi Eldien; AlMutairi, Abdulrahman; Roberts, Christopher; van der Vleuten, Cees

2011-01-01

The aim of this study is to explore the effects of clinical supervision, and assessment characteristics on the study strategies used by undergraduate medical students during their clinical rotations. We conducted a qualitative phenomenological study at King Saud Bin Abdulaziz University for Health Sciences, College of Medicine, Riyadh, Saudi…

Clinical Features and Related Factors of Poststroke Pathological Laughing and Crying: A Case-Control Study.

PubMed

Wang, Geying; Teng, Fei; Chen, Yuhui; Liu, Yuanhua; Li, Yancheng; Cai, Li; Zhang, Xu; Nie, Zhiyu; Jin, Lingjing

2016-03-01

The purpose of this study was to analyze clinical features and related factors of poststroke pathological laughing and crying (PSPLC) and to differentiate PSPLC patients with and without pseudobulbar signs. We performed a case-control study in which 56 patients with PSPLC were matched to 56 control stroke patients by age and gender. The pathological laughing and crying scale was used to identify patients with PSPLC. Characteristics of PSPLC outbursts, presence of pseudobulbar signs and autonomic symptoms, lesion locations, and different clinical data were analyzed. Mild cognitive impairment (MCI) was evaluated by the Montreal Cognitive Assessment. Poststroke anger proneness (PSAP) was evaluated by comparison of the patients' premorbid states. Significantly more patients in the PSPLC group showed MCI, PSAP, and pseudobulbar signs than those in the control group. Most patients with PSPLC showed bilateral multiple lesions and the pons (especially the bilateral paramedian basal and basal-tegmental areas) stood out as the most important lesion location. Logistic regression analysis showed that pontine lesion, MCI, and PSAP were independently related to PSPLC; however, the presence of pseudobulbar signs was not related. PSPLC patients with pseudobulbar signs showed more recurrent strokes in the previous 2 years, more severe neurological deficits, as well as higher severity of PSPLC. In addition, more patients in the group with pseudobulbar signs showed concomitant autonomic symptoms. PSPLC, MCI, and PSAP could be manifestations of a more general disorder, in which pontine lesion plays an important role. PSPLC patients with pseudobulbar signs and those without show different features. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Study Shows Aspirin Reduces Colorectal Cancer in Those at High Risk

Cancer.gov

Findings from the first large clinical trial of its kind indicate that taking high doses of aspirin daily for at least 2 years substantially reduces the risk of colorectal cancer among people at increased risk of the disease.

Acute posttraumatic stress symptoms and depression after exposure to the 2005 Saskatchewan Centennial Air Show disaster: prevalence and predictors.

PubMed

Taylor, Steven; Asmundson, Gordon J G; Carleton, R Nicholas; Brundin, Peter

2007-01-01

The purpose of this study was to determine the prevalence of acute distress-that is, clinically significant posttraumatic stress symptoms (PTSS) and depression-and to identify predictors of each in a sample of people who witnessed a fatal aircraft collision at the 2005 Saskatchewan Centennial Air Show. Air Show attendees (N = 157) were recruited by advertisements in the local media and completed an Internet-administered battery of questionnaires. Based on previously established cut-offs, 22 percent respondents had clinically significant PTSS and 24 percent had clinically significant depressive symptoms. Clinically significant symptoms were associated with posttrauma impairment in social and occupational functioning. Acute distress was associated with several variables, including aspects of Air Show trauma exposure, severity of prior trauma exposure, low posttrauma social support (ie, negative responses by others), indices of poor coping (eg, intolerance of uncertainty, rumination about the trauma), and elevated scores on anxiety sensitivity, the personality trait of absorption, and dissociative tendencies. Results suggest that clinically significant acute distress is common in the aftermath of witnessed trauma. The statistical predictors (correlates) of acute distress were generally consistent with the results of studies of other forms of trauma. People with elevated scores on theoretical vulnerability factors (eg, elevated anxiety sensitivity) were particularly likely to develop acute distress.

The contribution of traditional healers' clinics to public health care system in Addis Ababa, Ethiopia: a cross-sectional study

PubMed Central

2011-01-01

Background Ethiopian people have been using traditional medicine since time immemorial with 80% of its population dependent on traditional medicines. However, the documentation of traditional healers' clinics contribution to modern public health system in cosmopolitan cities is scanty. Studies conducted so far are limited and focused on the perceptions and practices of modern and traditional health practitioners about traditional medicine. Thus, a cross sectional study was conducted from February to May 2010 to assess the contribution of traditional healers' clinics to public health care system in Addis Ababa. Materials and methods Ten traditional healers who were willing to participate in the study and 306 patients who were visiting these traditional healers' clinics were interviewed using two types of semi-structured questionnaires. Data were summarized using percentages, tables and bar chart. Results The diseases mostly treated by traditional healers were wound, inflammation, herpes zoster, hemorrhoids, fracture, paralysis, back-pain, liver diseases, cancer and eczema. This study showed that traditional healers' clinics considerably contribute to public health care in Addis Ababa. Fifty two percent of patients reported that traditional healers' clinics were their first choice when they faced health problems. The reasons for visiting these clinics were 175 (57.2%) efficacy, 109 (35.6%) dissatisfaction with modern medicine, 10 (3.3%) dissatisfaction with modern medicine and efficacy, 6 (2.0%) cost and 6 (2.0%) dissatisfaction and cost. Females (55.2%), young age (20-40 years, 65.0%), never married (56.9%), orthodox (73.9%), Amhara (52.3%), educational status above grade 12 (34.6%) and government employees (29.4%) were frequent visitors. Healers reported that there was no form of cooperation with modern health professionals. The reasons were lack of motivation to collaborate and communicate with modern health service workers. Family based apprenticeship was the

Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study

PubMed Central

2010-01-01

Background Traditional peripheral biofeedback has grade A evidence for effectively treating migraines. Two newer forms of neurobiofeedback, EEG biofeedback and hemoencephalography biofeedback were combined with thermal handwarming biofeedback to treat 37 migraineurs in a clinical outpatient setting. Methods 37 migraine patients underwent an average of 40 neurofeedback sessions combined with thermal biofeedback in an outpatient biofeedback clinic. All patients were on at least one type of medication for migraine; preventive, abortive or rescue. Patients kept daily headache diaries a minimum of two weeks prior to treatment and throughout treatment showing symptom frequency, severity, duration and medications used. Treatments were conducted an average of three times weekly over an average span of 6 months. Headache diaries were examined after treatment and a formal interview was conducted. After an average of 14.5 months following treatment, a formal interview was conducted in order to ascertain duration of treatment effects. Results Of the 37 migraine patients treated, 26 patients or 70% experienced at least a 50% reduction in the frequency of their headaches which was sustained on average 14.5 months after treatments were discontinued. Conclusions All combined neuro and biofeedback interventions were effective in reducing the frequency of migraines with clients using medication resulting in a more favorable outcome (70% experiencing at least a 50% reduction in headaches) than just medications alone (50% experience a 50% reduction) and that the effect size of our study involving three different types of biofeedback for migraine (1.09) was more robust than effect size of combined studies on thermal biofeedback alone for migraine (.5). These non-invasive interventions may show promise for treating treatment-refractory migraine and for preventing the progression from episodic to chronic migraine. PMID:20205867

Informatics tools to improve clinical research study implementation.

PubMed

Brandt, Cynthia A; Argraves, Stephanie; Money, Roy; Ananth, Gowri; Trocky, Nina M; Nadkarni, Prakash M

2006-04-01

There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. We describe an approach that emphasizes the use of a variety of informatics tools that can facilitate study coordination, training, data checks and early identification and correction of faulty procedures and data problems. The paper focuses on informatics tools that can help in case report form design, procedures and training and data management. Informatics tools can be used to facilitate study coordination and implementation of clinical research trials.

Miki (Mitotic Kinetics Regulator) Immunoexpression in Normal Liver, Cirrhotic Areas and Hepatocellular Carcinomas: a Preliminary Study with Clinical Relevance.

PubMed

Fernández-Vega, Iván; Santos-Juanes, Jorge; Camacho-Urkaray, Emma; Lorente-Gea, Laura; García, Beatriz; Gutiérrez-Corres, Francisco Borja; Quirós, Luis M; Guerra-Merino, Isabel; Aguirre, José Javier

2018-02-12

Hepatocellular carcinoma (HCC) is the most common type of primary malignant tumor in the liver. One of the main features of cancer survival is the generalized loss of growth control exhibited by cancer cells, and Miki is a protein related to the immunoglobulin superfamily that plays an important role in mitosis. We aim to study protein expression levels of Miki in non-tumoral liver and 20 HCCs recruited from a Pathology Department. Clinical information was also obtained. A tissue microarray was performed, and immunohistochemical techniques applied to study protein expression levels of Miki. In normal liver, Miki was weakly expressed, showing nuclear staining in the hepatocytes. Cirrhotic areas and HCCs showed a variety of staining patterns. Most HCC samples showed positive expression, with three different staining patterns being discernible: nuclear, cytoplasmic and mixed. Statistical analysis showed a significant association between grade of differentiation, Ki-67 proliferative index, survival rates and staining patterns. This study has revealed the positive expression of Miki in normal liver, cirrhotic areas and HCCs. Three different staining patterns of Miki expression with clinical relevance were noted in HCCs.

Extended cooperation in clinical studies through exchange of CDISC metadata between different study software solutions.

PubMed

Kuchinke, W; Wiegelmann, S; Verplancke, P; Ohmann, C

2006-01-01

Our objectives were to analyze the possibility of an exchange of an entire clinical study between two different and independent study software solutions. The question addressed was whether a software-independent transfer of study metadata can be performed without programming efforts and with software routinely used for clinical research. Study metadata was transferred with ODM standard (CDISC). Study software systems employed were MACRO (InferMed) and XTrial (XClinical). For the Proof of Concept, a test study was created with MACRO and exported as ODM. For modification and validation of the ODM export file XML-Spy (Altova) and ODM-Checker (XML4Pharma) were used. Through exchange of a complete clinical study between two different study software solutions, a Proof of Concept of the technical feasibility of a system-independent metadata exchange was conducted successfully. The interchange of study metadata between two different systems at different centers was performed with minimal expenditure. A small number of mistakes had to be corrected in order to generate a syntactically correct ODM file and a "vendor extension" had to be inserted. After these modifications, XTrial exhibited the study, including all data fields, correctly. However, the optical appearance of both CRFs (case report forms) was different. ODM can be used as an exchange format for clinical studies between different study software. Thus, new forms of cooperation through exchange of metadata seem possible, for example the joint creation of electronic study protocols or CRFs at different research centers. Although the ODM standard represents a clinical study completely, it contains no information about the representation of data fields in CRFs.

The social well-being of nurses shows a thirst for a holistic support: A qualitative study

PubMed Central

Mozaffari, Naser; Peyrovi, Hamid; Nayeri, Nahid Dehghan

2015-01-01

Introduction Social well-being is one of the important aspects of health. In fact, this is a reflection of experience in a social environment, indicating how social challenges are determined. In other words, social well-being is an explanation of people's perception and experience of being in a good situation, satisfaction with the structure, and social interaction. This qualitative study intended to explore nurses’ experience of social well-being. Methods Qualitative content analysis was used to conduct the study. Through purposive sampling, a total of 18 nurses with various clinical experiences participated in semi-structured interviews. The data were analysed using the five-step, qualitative content analysis introduced by Graneheim and Lundman. Results The main theme extracted from the data analysis was “thirst for a holistic support” in nurses. It consisted of two subthemes including internal support (family's support, colleague's support, and organizational support) and external support (society's support and media's support). Conclusions and discussion Nurses’ experiences in shaping their social well-being show that nurses need support in order to rebuild their social well-being. It is supported in partnership with the media, the community, health-related organizations, and by nurses and family. This improves job satisfaction, hope, motivation, commitment, and confidence so as to ultimately facilitate improvement of social well-being of nurses. PMID:26381217

Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

PubMed

Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

2015-01-01

We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies.

PubMed

Fermaglich, Lewis J; Chen, Ru; Kim, Carol Y; Chuh, Eunjung Esther; Thomas, Teena; Shetty, Daiva; Lee, Julia; Young, Johnny; Fan, Ying

2018-01-01

The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) studies received by the US Food and Drug Administration (FDA) between 2007 and 2017, to help applicants avoid common deficiencies, minimize "refuse-to-receive" (RTR) actions, "information requests," and ANDA approval delays. Multiple internal FDA databases were searched to evaluate and summarize common deficiencies identified in ANDA submissions containing clinical endpoint studies and skin I/S/A studies that required review by the Division of Clinical Review. A total of 275 ANDA submissions with filing reviews from January 2007 to June 2017 were analyzed in this report. Two hundred eighteen (79.3%) filing reviews contained one or more deficiencies. Seventy-nine (28.7%) ANDAs were issued RTR letters because of major clinical deficiencies, specifically bioequivalence and clinical deficiencies, accounting for 9% of overall identified deficiencies. Twenty-two other categories of deficiencies are summarized into 4 main categories: missing information related to the clinical studies other than data sets (38%), missing data sets (35%), formulation issues (12%), and organization/format issues (6%). The most common deficiency in the "missing information related to the clinical studies other than data sets" category was "missing clarification of information" (22%). We also noted that the Division of Filing Review has identified these same types of deficiencies since assuming responsibility of the filing assessment for ANDAs with clinical endpoint BE studies and skin I/S/A studies. In conclusion, to minimize "refuse-to-receive" actions, "information requests," and approval of ANDA delays for generic drug products, applicants should submit full clinical study reports, including all data sets for drug products recommending clinical

[Clinical studies on flomoxef in respiratory tract infections].

PubMed

Kanegae, H; Yamada, H; Yamaguchi, T; Kuroki, S; Katoh, O

1987-10-01

Flomoxef (FMOX, 6315-S) is a new oxacephem with a broad spectrum of antimicrobial activity. We used FMOX for treatment of 13 patients with respiratory tract infections including 4 cases of pneumonia, 5 of lung abscess and 4 of exacerbation of the chronic airway diseases. FMOX showed excellent in vitro antimicrobial activities against clinical isolates including 4 strains of Streptococcus pneumoniae, 2 strains of Haemophilus influenzae and each one strain of Escherichia coli and Klebsiella pneumoniae. Clinical responses were excellent in 3 cases, good in 7 and fair or poor in 3. No side effect was observed, but abnormal laboratory findings caused by FMOX administration were found in 2 cases; hypertransaminasemia and eosinophilia. However, neither of them was severe. From the above results, it is considered that FMOX will be useful for treatment of patients with respiratory tract infections.

Sub-epithelial connective tissue graft for root coverage in nonsmokers and smokers: A pilot comparative clinical study

PubMed Central

Dwarakanath, Chini Doraswamy; Divya, Bheemavarapu; Sruthima, Gottumukkala Naga Venkata Satya; Penmetsa, Gautami Subadra

2016-01-01

Background: Gingival recession is a common condition and is more prevalent in smokers. It is widely believed that root coverage procedures in smokers result in less desirable outcome compared to nonsmokers', and there are few controlled studies in literature to support this finding. Therefore, the purpose of this study was to evaluate and compare the outcome of root coverage with sub-epithelial connective tissue graft (SCTG) in nonsmokers and smokers. Materials and Methods: A sample of twenty subjects, 10 nonsmokers and 10 smokers were selected each with at least 1 Miller's Class I or II recession on a single rooted tooth. Clinical measurements of probing depth, clinical attachment level (CAL), gingival recession total surface area (GRTSA), depth of recession (RD), width of recession (RW), and width of keratinized tissue were determined at baseline, 3, and 6 months after surgery. Results: The treatment of gingival recession with SCTG and coronally advanced flap showed a decrease in the GRTSA, RD, RW, and an increase in CAL and width of keratinized gingiva in both the groups. However, the intergroup comparison of the clinical parameters showed no statistical significance. About 6 out of 10 nonsmokers (60%) and 3 smokers (30%) showed complete root coverage. The mean percentage of root coverage of 71.2% in nonsmokers and 38% in smokers was observed. Conclusion: The results of the present study suggest that smoking may negatively influence gingival recession reduction and CAL gain. In addition, smokers may exhibit fewer chances of complete root coverage. Overall, nonsmokers showed better improvements in all the parameters compared to smokers at the end of 6 months. PMID:28298827

Improving Translation from Preclinical Studies to Clinical Trials in Acute Kidney Injury.

PubMed

Fiorentino, Marco; Kellum, John A

2018-05-23

Several cellular and molecular targets and mechanisms have been investigated in preclinical studies of acute kidney injury (AKI), but translation in successful clinical studies has failed to date. This article reviews many issues that have limited this and the potential future perspectives in AKI prevention and treatment. Preclinical models of AKI should closely mimic the complexity of human AKI, considering the importance of several comorbidities in determining the clinical course and outcomes in the human disease. Moreover, studies should test novel interventions in models where AKI is already established, instead of focusing only at primary prevention. AKI definitions and endpoints in animal studies should be similar to those applied in clinical studies; in particular, AKI biomarkers should be implemented to guide patient selection for clinical trials and monitor intervention efficacy. In this scenario, cell-cycle arrest biomarkers have been widely investigated as AKI predictors in both preclinical and clinical studies and they serve as useful tools for future interventional studies. A better understanding of human AKI through a large collection of biological samples and kidney biopsies and omics applications, and an iterative relationship between preclinical and clinical studies are critical steps to improve future preclinical models and clinical trials. Finally, given the great variability in clinical manifestation of AKI, a strong collaboration between research centers and industry is recommended. Key messages: Several methodological issues have hampered the translation of basic research findings in clinical studies, and overcoming these obstacles is necessary to achieve success. © 2018 S. Karger AG, Basel.

Analysis of Published Criteria for Clinically Inactive Disease in a Large Juvenile Dermatomyositis Cohort Shows That Skin Disease Is Underestimated.

PubMed

Almeida, Beverley; Campanilho-Marques, Raquel; Arnold, Katie; Pilkington, Clarissa A; Wedderburn, Lucy R; Nistala, Kiran

2015-09-01

The Pediatric Rheumatology International Trials Organisation (PRINTO) recently published criteria for classification of patients with juvenile dermatomyositis (DM) as having clinically inactive disease. The criteria require that at least 3 of 4 conditions be met, i.e., creatine kinase level ≤150 units/liter, Childhood Myositis Assessment Scale score ≥48, Manual Muscle Testing in 8 muscles score ≥78, and physician's global assessment of overall disease activity (PGA) ≤0.2. The present study was undertaken to test these criteria in a UK cohort of patients with juvenile DM. We assessed 1,114 patient visits for the 4 items in the PRINTO criteria for clinically inactive disease. Each visit was analyzed to determine whether skin disease was present. The Disease Activity Score (DAS) for juvenile DM was determined in 59 patients. At 307 of the 1,114 visits, clinically inactive disease was achieved based on the 3 muscle criteria (but with a PGA of >0.2); rash was present at 65.8% of these visits and nailfold capillary abnormalities at 35.2%. When PGA ≤0.2 was one of the 3 criteria that were met, the frequency of skin signs was significantly lower (rash in 23.1% and nailfold capillary abnormalities in 8.7%). If PGA was considered an essential criterion for clinically inactive disease (P-CID), patients with active skin disease were less likely to be categorized as having clinically inactive disease (a median DAS skin score of 0 [of a possible maximum of 9] in visits where the PGA was ≤0.2, versus a median DAS skin score of 4 in patients meeting the 3 muscle criteria [with a PGA of >0.2]; P < 0.001). Use of the P-CID led to improvements in the positive predictive value and the positive likelihood ratio (85.4% and 11.0, respectively, compared to 72.9% and 5.1 with the current criteria). There was a high frequency of skin disease among patients with juvenile DM who did not meet the PGA criterion for inactive disease but met the other 3 criteria. Incorporating PGA as

Physiotherapists' beliefs and attitudes influence clinical practice in chronic low back pain: a systematic review of quantitative and qualitative studies.

PubMed

Gardner, Tania; Refshauge, Kathryn; Smith, Lorraine; McAuley, James; Hübscher, Markus; Goodall, Stephen

2017-07-01

What influence do physiotherapists' beliefs and attitudes about chronic low back pain have on their clinical management of people with chronic low back pain? Systematic review with data from quantitative and qualitative studies. Quantitative and qualitative studies were included if they investigated an association between physiotherapists' attitudes and beliefs about chronic low back pain and their clinical management of people with chronic low back pain. Five quantitative and five qualitative studies were included. Quantitative studies used measures of treatment orientation and fear avoidance to indicate physiotherapists' beliefs and attitudes about chronic low back pain. Quantitative studies showed that a higher biomedical orientation score (indicating a belief that pain and disability result from a specific structural impairment, and treatment is selected to address that impairment) was associated with: advice to delay return to work, advice to delay return to activity, and a belief that return to work or activity is a threat to the patient. Physiotherapists' fear avoidance scores were positively correlated with: increased certification of sick leave, advice to avoid return to work, and advice to avoid return to normal activity. Qualitative studies revealed two main themes attributed to beliefs and attitudes of physiotherapists who have a relationship to their management of chronic low back pain: treatment orientation and patient factors. Both quantitative and qualitative studies showed a relationship between treatment orientation and clinical practice. The inclusion of qualitative studies captured the influence of patient factors in clinical practice in chronic low back pain. There is a need to recognise that both beliefs and attitudes regarding treatment orientation of physiotherapists, and therapist-patient factors need to be considered when introducing new clinical practice models, so that the adoption of new clinical practice is maximised. [Gardner T

Patient navigation based on predictive modeling decreases no-show rates in cancer care.

PubMed

Percac-Lima, Sanja; Cronin, Patrick R; Ryan, David P; Chabner, Bruce A; Daly, Emily A; Kimball, Alexandra B

2015-05-15

Patient adherence to appointments is key to improving outcomes in health care. "No-show" appointments contribute to suboptimal resource use. Patient navigation and telephone reminders have been shown to improve cancer care and adherence, particularly in disadvantaged populations, but may not be cost-effective if not targeted at the appropriate patients. In 5 clinics within a large academic cancer center, patients who were considered to be likely (the top 20th percentile) to miss a scheduled appointment without contacting the clinic ahead of time ("no-shows") were identified using a predictive model and then randomized to an intervention versus a usual-care group. The intervention group received telephone calls from a bilingual patient navigator 7 days before and 1 day before the appointment. Over a 5-month period, of the 40,075 appointments scheduled, 4425 patient appointments were deemed to be at high risk of a "no-show" event. After the patient navigation intervention, the no-show rate in the intervention group was 10.2% (167 of 1631), compared with 17.5% in the control group (280 of 1603) (P<.001). Reaching a patient or family member was associated with a significantly lower no-show rate (5.9% and 3.0%, respectively; P<.001 and .006, respectively) compared with leaving a message (14.7%: P = .117) or no contact (no-show rate, 21.6%: P = .857). Telephone navigation targeted at those patients predicted to be at high risk of visit nonadherence was found to effectively and substantially improve patient adherence to cancer clinic appointments. Further studies are needed to determine the long-term impact on patient outcomes, but short-term gains in the optimization of resources can be recognized immediately. © 2015 American Cancer Society.

[Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

PubMed

Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

2013-11-01

By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

A proof-of-concept clinical study examining the NRF2 activator sulforaphane against neutrophilic airway inflammation.

PubMed

Duran, Charity G; Burbank, Allison J; Mills, Katherine H; Duckworth, Heather R; Aleman, Maria M; Kesic, Matthew J; Peden, David B; Pan, Yinghao; Zhou, Haibo; Hernandez, Michelle L

2016-07-22

Sulforaphane (SFN), a naturally occurring isothiocyanate found in cruciferous vegetables, is implicated as a possible therapy for airway inflammation via induction of the transcription factor NF-E2-related factor 2 (NRF2). In this proof-of-concept clinical study, we show that supplementation of SFN with broccoli sprout homogenate in healthy human subjects did not induce expression of antioxidant genes or protect against neutrophilic airway inflammation in an ozone-exposure model. Therefore, dietary sulforaphane supplementation is not a promising candidate for larger scale clinical trials targeting airway inflammation. NCT01625130 . Registered 19 June, 2012.

Brief review of published alprazolam clinical studies

PubMed Central

Straw, R. N.

1985-01-01

1 The clinical efficacy of alprazolam has been evaluated in both anxiety states and depressive disorders. In anxiety neurosis, studies have been conducted vs placebo and/or other benzodiazepine tranquilizers. Reports, to date, with regard to panic/phobia disorders have been limited to open-label studies and a single report from a placebo-controlled study. In depression, both open-label and double-blind studies (vs tricyclic antidepressants) have been published. PMID:2859879

The Clinical Value of Prenatal 3D Ultrasonic Diagnosis on Fetus Hemivertebra Deformity- A Preliminary Study.

PubMed

Wen, Yanting; Xiang, Guishuang; Liang, Xiaoqiu; Tong, Xiaoqian

2018-02-01

The present study is planned to discuss the clinical value of prenatal 3D ultra-sonic diagnosis on fetus hemivertebra deformity through the retrospective analysis of clinical data of fetus hemivertebra deformity. Selected 9 fetus hemivertebra deformity cases, which have been admitted to our hospital during the period from January, 2010 to January, 2016 as study samples, and analyzed their 2D and 3D ultrasonic examination data. 4 cases of the fetus hemivertebra deformity occurred at lumbar vertebra, 3 cases at thoracic vertebra, and 2 cases at thoracolumbar vertebra. There were scoliosis and opened spine bifida (OSB). In 7 cases, there was absence of ribs in fetus. The 2D ultrasonic image showed that: The echo at the center of fetus vertebral arch lesion was blurred or lost. The coronal section showed the deformity of the spine. There was obvious loss of the ossification center. From the cross section, we could see that the vertebral body of the fetus was shrinking and the edges were relatively blurred. The 3D ultrasonic image showed that: the echo at the ossification center of the fetus vertebra was relatively blurred, or even lost. The image also indicated scoliosis deformity of the spine. The vertebral body lesion could be accurately located. 9 cases of fetus hemivertebra deformity have been detected through examination. Labor inductions have been carried out after getting the permission from the family members. The X-ray examination of the fetus after labor induction showed that the diagnosis was correct. Prenatal ultra-sonic examination holds strong potential for the diagnosis of fetus hemivertebra deformity quite early and deserves further clinical evaluation with large sample size.

[Clinical studies of flomoxef in the field of pediatrics].

PubMed

Ito, S; Mayumi, M; Mikawa, H

1987-08-01

Flomoxef (FMOX, 6315-S), a newly synthesized antibiotic which belongs to the oxacephem group, was clinically evaluated for its efficacy and safety in 17 patients with ages ranging from 1 month to 9 year-8-month who had bacterial infections. The results obtained were summarized as follows. 1. A pharmacokinetic study following 20 mg/kg FMOX administration by intravenous bolus injection showed that the half-life of FMOX (beta phase) was 39.8 minutes and the urinary excretion of FMOX in the first 6 hours was 76.5%. 2. FMOX was administered to 3 patients with pneumonia, 8 patients with bronchopneumonia, 2 patients with tonsillitis, 2 patients with pyelonephritis, one patient each with cervical lymphadenitis, and pustulosis associated with severe varicella at daily dosage levels of 61.9 approximately 87.2 mg/kg, divided into 3 or 4 administrations by intravenous bolus injection or by 30 minutes drip infusion. The clinical results of these 17 patients were as follows; excellent: 14 patients, good: 2 patients, poor: 1 patient. The efficacy rate was 94.1%. 3. No clinical adverse reaction was observed in any of the 17 patients. Neutropenia, eosinophilia, a slight elevation of GPT and slight elevations of GOT & GPT were observed in 1, 1, 1, and 2 patients, respectively. No abnormality in coagulation system was observed in any of 10 evaluable patients. 4. MICs of FMOX against 13 strains isolated from patients were as follows. MIC against 2 out of 3 strains of Streptococcus pneumoniae was 0.20 micrograms/ml and that of the remaining 1 strain was 0.39 micrograms/ml.(ABSTRACT TRUNCATED AT 250 WORDS)

The administration of music therapy training clinics: a descriptive study.

PubMed

Abbott, Elaine A

2006-01-01

A two-part study was conducted to describe issues and administrative practices related to university and college affiliated music therapy training clinics. First, all 72 AMTA academic directors were surveyed in order to discover (a) which programs had a clinic, and (b) the reasons why other directors did not operate a clinic. Second, 12 survey respondents, who reported that they were involved with a training clinic, participated in in-depth interviews discussing: (a) their motivations for establishing a clinic, (b) the possible effects of a clinic on the community, (c) the individuals and groups involved in clinic operations, d) clinic space and equipment, (e) policy and procedure topics, (f) specific administrative practices related to clients and students, (g) finances, (h) research (i) quality assurance, (j) dual roles, and (k) liability issues. The administrative practices described by the interviewees varied greatly across clinics and provided a wealth of information that could be considered both useful and thought provoking for those interested in operating a music therapy clinic.

Polysomnographic Findings and Clinical Correlates in Huntington Disease: A Cross-Sectional Cohort Study

PubMed Central

Piano, Carla; Losurdo, Anna; Della Marca, Giacomo; Solito, Marcella; Calandra-Buonaura, Giovanna; Provini, Federica; Bentivoglio, Anna Rita; Cortelli, Pietro

2015-01-01

Study Objectives: To evaluate the sleep pattern and the motor activity during sleep in a cohort of patients affected by Huntington disease (HD). Design: Cross-sectional cohort study. Setting: Sleep laboratory. Patients: Thirty HD patients, 16 women and 14 men (mean age 57.3 ± 12.2 y); 30 matched healthy controls (mean age 56.5 ± 11.8 y). Interventions: Subjective sleep evaluation: Epworth Sleepiness Scale (ESS); Berlin's Questionnaire, interview for restless legs syndrome (RLS), questionnaire for REM sleep behavior disorder (RBD). Clinical evaluation: disease duration, clinical severity (unified Huntington disease motor rating scale [UHDMRS]), genetic tests. Laboratory-based full-night attended video-polysomnography (V-PSG). Measurements and Results: The duration of the disease was 9.4 ± 4.4 y, UHMDRS score was 55.5 ± 23.4, CAG repeats were 44.3 ± 4.1. Body mass index was 21.9 ± 4.0 kg/m2. No patients or caregivers reported poor sleep quality. Two patients reported symptoms of RLS. Eight patients had an ESS score ≥ 9. Eight patients had high risk of obstructive sleep apnea. At the RBD questionnaire, two patients had a pathological score. HD patients, compared to controls, showed shorter sleep, reduced sleep efficiency index, and increased arousals and awakenings. Four patients presented with sleep disordered breathing (SDB). Periodic limb movements (PLMs) during wake and sleep were observed in all patients. No episode of RBD was observed in the V-PSG recordings, and no patients showed rapid eye movement (REM) sleep without atonia. The disease duration correlated with ESS score (P < 0.02). UHMDRS correlated positively with the ESS score (P < 0.005), and negatively with the percentage of REM sleep. Conclusions: Patients with Huntington disease showed a severe sleep disruption and a high prevalence of periodic limb movements, but no evidence of sleep disordered breathing or REM sleep behavior disorder. Citation: Piano C, Losurdo A, Della Marca G, Solito M

The transfer of theoretical knowledge to clinical practice by nursing students and the difficulties they experience: A qualitative study.

PubMed

Günay, Ulviye; Kılınç, Gülsen

2018-06-01

Nursing education contains both theoretical and practical training processes. Clinical training is the basis of nursing education. The quality of clinical training is closely related to the quality of the clinical learning environment. This study aimed to determine the transfer of theoretical knowledge into clinical practice by nursing students and the difficulties they experience during this process. A qualitative research design was used in the study. The study was conducted in 2015 with 30 nursing students in a university located in the east of Turkey, constituting three focus groups. The questions directed to the students during the focus group interviews were as follows: What do you think about your clinical training? How do you evaluate yourself in the process of putting your theoretical knowledge into clinical practice? What kind of difficulties are you experiencing in clinical practices? The data were interpreted using the method of content analysis. Most of the students reported that theoretical information they received was excessive, their ability to put most of this information into practice was weak, and they lacked courage to touch patients for fear of implementing procedures incorrectly. As a result of the analysis of the data, five main themes were determined: clinical training, guidance and communication, hospital environment and expectations. The results of this study showed that nursing students found their clinical knowledge and skills insufficient and usually failed to transfer their theoretical knowledge into clinical practices. The study observed that nursing students experienced various issues in clinical practices. In order to fix these issues and achieve an effective clinical training environment, collaboration should be achieved among nursing instructors, nurses, nursing school and hospital managements. Additionally, the number of nursing educators should be increased and training programs should be provided regarding effective clinical

Molecular docking studies shows tivozanib and lapatinib as potential inhibitors of EML4-ALK translocation mediated fusion protein in non small cell lung cancer.

PubMed

Ramshankar, Vijayalakshmi; Yegnaswamy, Subha; P, Kumarasamy; Arvind, Krishnamurthy

2014-01-01

Identification of activating mutations in non-small cell lung cancers (NSCLC) has been a focus in recent years. This led to successful evidence of using tyrosine kinase inhibitors (TKIs) over the standard platinum doublet based chemotherapy as the first line treatment in the metastatic setting.The rearrangements of fusion protein EML4-ALK in NSCLC lead to the use of crizotinib for this class of tumors. Preclinical and Phase 1 clinical studies show that ceritinib is more effective against both crizotinib sensitive and resistant tumors. Although robust responses to crizotinib are observed in NSCLC harboring ALK mutations, majority of tumors eventually become resistant, posing a major challenge in treatment course. Thus, there is a need for the identification and development of second-generation of ALK inhibitors. Computer aided molecular docking data show Tivozanib and Lapatinib bind EML4-ALK with high score. Tivozanib is in clinical trials for renal cell cancer and Lapatinib is a known dual tyrosine kinase inhibitor effective in breast cancer patients with HER2 over-expression. Additional data on these compounds for use in EML4-ALK positive NSCLC will provide evidence for use in patients treated with crizotinib. Data shows the importance of computer aided molecular docking in developing candidates with improved activity for further consideration in vitro and in vivo validation.

Molecular docking studies shows tivozanib and lapatinib as potential inhibitors of EML4-ALK translocation mediated fusion protein in non small cell lung cancer

PubMed Central

Ramshankar, Vijayalakshmi; Yegnaswamy, Subha; P, Kumarasamy; Arvind, Krishnamurthy

2014-01-01

Identification of activating mutations in non-small cell lung cancers (NSCLC) has been a focus in recent years. This led to successful evidence of using tyrosine kinase inhibitors (TKIs) over the standard platinum doublet based chemotherapy as the first line treatment in the metastatic setting.The rearrangements of fusion protein EML4-ALK in NSCLC lead to the use of crizotinib for this class of tumors. Preclinical and Phase 1 clinical studies show that ceritinib is more effective against both crizotinib sensitive and resistant tumors. Although robust responses to crizotinib are observed in NSCLC harboring ALK mutations, majority of tumors eventually become resistant, posing a major challenge in treatment course. Thus, there is a need for the identification and development of second-generation of ALK inhibitors. Computer aided molecular docking data show Tivozanib and Lapatinib bind EML4-ALK with high score. Tivozanib is in clinical trials for renal cell cancer and Lapatinib is a known dual tyrosine kinase inhibitor effective in breast cancer patients with HER2 over-expression. Additional data on these compounds for use in EML4-ALK positive NSCLC will provide evidence for use in patients treated with crizotinib. Data shows the importance of computer aided molecular docking in developing candidates with improved activity for further consideration in vitro and in vivo validation. PMID:25489176

Clinical and subclinical leaks after low colorectal anastomosis: a clinical and radiologic study.

PubMed

Lim, Michael; Akhtar, Saleem; Sasapu, Kishore; Harris, Keith; Burke, Dermot; Sagar, Peter; Finan, Paul

2006-10-01

This study was designed to examine the natural history of subclinical leaks and their effect on bowel function and quality of life and to evaluate water-soluble contrast enema features that predict anastomotic healing after leaks. Consecutive patients who underwent low rectal anastomosis were followed up postoperatively for leaks. All leaks were confirmed radiologically with CT scanning and water-soluble contrast enema imaging. Water-soluble contrast enemas were serially repeated to identify healing. Characteristics on initial water-soluble contrast enema were correlated with observed healing. Postoperatively, patients were required to fill in a quality of life and a bowel function questionnaire. A total of 138 patients underwent low rectal anastomosis procedures with a median follow-up period of 26 (interquartile range, 19-37) months. There were 23 documented leaks of which 13 (9 percent) presented clinically and 10 (8 percent) presented subclinically. Ileostomy closure was possible in 4 of 13 (30 percent) patients with a clinical leak and all 10 (100 percent) patients with a subclinical leak. Median quality of life scores were lower for patients with clinical leaks and no ileostomy closure (P = 0.03). Bowel function for subclinical leak patients and clinical leak patients with ileostomy closure were similarly impaired. The presence of a cavity (P = 0.01) and a stricture (P = 0.01) at the anastomotic site were unfavorable radiologic features associated with nonhealing. Subclinical leaks are more benign in their natural history compared with clinical leaks. Quality of life and bowel function is no better in patients with a subclinical leak compared with patients with a clinical leak who have ileostomy closure. Anastomotic leaks may resolve if favorable radiologic features are present.

Students' expectations of clinical teachers.

PubMed

Daniels, M; DeVos, D

1996-01-01

Clinical instructors play an essential role in the education of all health care students, including radiation therapy students. However, a review of the literature shows that no studies have examined radiation therapy students' expectations of their clinical instructors. To assess those expectations, a national survey was conducted of 282 radiation therapy students enrolled in 61 programs in 28 states. Survey results then were analyzed to generate a list of the students' expectations of clinical instructors and to look at possible significant relationships between the various groups surveyed. Survey results showed that the most common expectation among first-, second- and third-year radiation therapy students was that their clinical instructors "take time, both in explaining procedures and answering questions." Among fourth-year students, the most commonly cited expectation for clinical instructors was that they "model professionalism."

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

PubMed

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

2016-01-01

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

Concerns of nursing students beginning clinical courses: A descriptive study.

PubMed

Cowen, Kay J; Hubbard, Lori J; Hancock, Debbie Croome

2016-08-01

Students harbor fears related to the clinical environment that influence their participation and learning. Some studies have addressed general anxieties in undergraduate nursing students, but few have asked students to report their fears and concerns prior to entering the clinical environment. Therefore, this study examined the fears and concerns of undergraduate nursing students beginning clinical courses as well as their continued concerns upon completion of the first year of instruction. The study also assessed their confidence in physical assessment skills. Ninety-six junior nursing students enrolled in a generic baccalaureate nursing program completed a survey, two items of which asked about their fears and concerns related to beginning clinical experiences and their confidence in physical assessment. A follow up survey was completed at the end of the junior year by 72 students. Making a mistake, lack of course success, and not knowing how to do something were students' major concerns prior to the start of clinical experiences. Bad experiences with a nurse or instructor, freezing up, and uncomfortable patient/family experiences were also concerns. Not knowing how to do something persisted as a concern at the completion of the first year. Fears about being/feeling left alone in a clinical setting as well as concern about the senior year also emerged on the post survey. Confidence in physical assessment was a mean of 60.46 on a scale of 0-100 at the beginning of clinical instruction and 71.28 at the end of the junior year. Faculty should structure learning activities that decrease anxiety and enhance students' confidence prior to initial clinical experiences. Opportunities might include in-depth orientation to clinical settings and various simulations that allow practice of skills and communication. Awareness of predominant student fears and concerns can also guide staff nurses to provide a welcoming environment and enhance learning. Copyright © 2016 Elsevier

Exploring the experiences of novice clinical instructors in physical therapy clinical education: a phenomenological study.

PubMed

Greenfield, B H; Bridges, P H; Phillips, T A; Drill, A N; Gaydosik, C D; Krishnan, A; Yandziak, H J

2014-12-01

To explore the perceptions of novice physical therapy clinical instructors (CIs) about their interactions and teaching behaviours with physical therapy students. A phenomenological approach using semi-structured interviews and a focus group. Six novice physical therapy CIs (less than two years as a CI and supervised fewer than three students) were recruited purposefully from a large metropolitan area in the USA. All participants were credentialed by the American Physical Therapy Association as CIs. Transcripts of interview data and focus group data were analysed using interpretative analysis for themes and subthemes. Participants viewed the transition of students from the classroom to the clinic as their primary role, using strategies of 'providing a way in', 'fostering critical thinking', 'finding a balance', 'overcoming barriers' and 'letting go'. While novice CIs showed skill in fostering student reflection and providing orientation, they struggled with student autonomy and balancing the competing obligations of patient care and clinical instruction. They expressed issues related to anxiety and lack of confidence. In the future, novice CIs could benefit from training and support in these areas. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Establishing a Multicenter Longitudinal Clinical Cohort Study in Ethiopia: Advanced Clinical Monitoring of Antiretroviral Treatment Project.

PubMed

Teklu, Alula M; Tsegaye, Eyuel; Fekade, Daniel; Hailemelak, Abraham; Weiss, William; Hassen, Elham; Simmons, Nicole; Zewdu, Solomon; Berhan, Yifru; Getachew, Assefa; Hagos, Tesfalem; Alebachew, Achamyeleh; Damena, Melake; Sitotaw, Yohannes; Assefa, Yibeltal; Medhin, Girmay; Ruff, Andrea

2017-02-01

The purpose of this paper is to describe the establishment of the Advanced Clinical Monitoring of ART Project in Ethiopia for monitoring and evaluation of the longitudinal effectiveness of the ART program and to show the opportunities it presents. This cohort was established in response to the 2005 call by WHO for establishing additional mechanisms for stronger monitoring of ART and the need for creating the platform to generate evidence to guide the care given for the ever increasing number of patients on ART in Ethiopia. A participatory and multi-stage process which started from a consensus building workshop and steered by a mother protocol as well as guiding documents which dictated the degree of engagement and expectations was followed. The primary and secondary aims of the study were agreed upon. A multi-site longitudinal observational clinical cohort was established by a consortium of stakeholders including seven Ethiopian medical schools and their affiliated referral hospitals, John Hopkins University, Ethiopian Public Health Institute, Ministry of Science and Technology, US Centers for Disease Prevention and Control - CDC-Ethiopia, and the Federal Ministry of Health. Adult and adolescent cohorts covering the age range of 14+ years) and pediatric cohorts covering those below age 14 years were the two main cohorts. During the initial recruitment of these cohorts information was extracted from existing documents for a total of 2,100 adult participants. In parallel, a prospective cohort of 1,400 adult and adolescent patients were enrolled for ART initiation and follow-up. Using similar recruitment procedures, a total of 120 children were enrolled in each of retrospective and prospective cohorts. Replacement of participants were made in subsequent years based on lost follow up and death rates to maintain adequacy of the sample to be followed-up. Between January 2005 and August 2013 a total of 4,339 patients were followed for a median of 41.6 months and data on

Glutamine Randomized Studies in Early Life: The Unsolved Riddle of Experimental and Clinical Studies

PubMed Central

Briassouli, Efrossini; Briassoulis, George

2012-01-01

Glutamine may have benefits during immaturity or critical illness in early life but its effects on outcome end hardpoints are controversial. Our aim was to review randomized studies on glutamine supplementation in pups, infants, and children examining whether glutamine affects outcome. Experimental work has proposed various mechanisms of glutamine action but none of the randomized studies in early life showed any effect on mortality and only a few showed some effect on inflammatory response, organ function, and a trend for infection control. Although apparently safe in animal models (pups), premature infants, and critically ill children, glutamine supplementation does not reduce mortality or late onset sepsis, and its routine use cannot be recommended in these sensitive populations. Large prospectively stratified trials are needed to better define the crucial interrelations of “glutamine-heat shock proteins-stress response” in critical illness and to identify the specific subgroups of premature neonates and critically ill infants or children who may have a greater need for glutamine and who may eventually benefit from its supplementation. The methodological problems noted in the reviewed randomized experimental and clinical trials should be seriously considered in any future well-designed large blinded randomized controlled trial involving glutamine supplementation in critical illness. PMID:23019424

Clinical studies of the effectiveness and safety of antivenoms.

PubMed

Williams, David J; Habib, Abdulrazaq G; Warrell, David A

2018-05-07

In the 1890s, hyperimmune sera proved effective in animals against challenge by the snake venom against which they had been raised. They were first used, apparently successfully, in a human patient in about 1895. Since then, antivenoms have become accepted as the only reliable specific treatment for snake-bite envenoming. Despite decades of accumulated clinical experience and a number of published randomized comparative and observational studies, the clinical effectiveness and safety of some antivenoms remain open to question, due to a lack of robust randomized controlled trial data. Antivenoms in some poorly regulated markets may have high rates of potentially fatal adverse effects and their use must be balanced by demonstrable effectiveness. Even those manufactured to strict regulatory requirements may pose a rare risk of severe adverse reactions. Most antivenoms currently marketed around the world were registered without first being studied clinically. There is increasing pressure to subject antivenoms, even those that are long-established, to the same protocols of rigorous pre-clinical and clinical assessment that are standard regulatory requirements for other drugs. Conventional clinical testing progresses through Phases I, II, III to IV. Most authorities consider antivenoms too dangerous to be used in Phase I studies in healthy volunteers. An alternative method for preliminary estimation of safety, dose-finding and effectiveness, is proposed - the "3 + 3" dose escalation or de-escalation design, in volunteer patients, as used in oncology to test cytotoxic drugs. Antivenoms are so widely used and well trusted, that there are few ethical justifications for placebo controls. However, placebo might be ethically justified if there were no proven effective treatment and or if withholding or delaying treatment posed acceptably negligible risks to the participants. Antivenom trials are most urgently needed in low-to middle-income countries where there are many

An Alternative Study of Transfer of Learning in Clinical Evaluation.

ERIC Educational Resources Information Center

Patel, Vimla; Cranton, Patricia A.

The use of an alternative methodology to study transfer of learning in clinical instruction during medical school was investigated. The environment in which clinical instruction takes place was examined, after which hypotheses were proposed and tested in a quasi-experimental design. The first phase of the study, an ethnographic analysis of the…

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

PubMed Central

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

2013-01-01

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

Primer: establishing a clinical trial unit--obtaining studies and patients.

PubMed

Fleischmann, Roy

2007-08-01

Rheumatologists with clinical expertise should perform clinical investigations of new molecules in an effort to discover therapies that could be of greater benefit or safety than those currently available for patients with chronic rheumatic diseases. Over the past few years, many studies have been conducted outside the United States and Europe because of the dearth of investigative sites in these countries. A clinician, whether in private practice or academia, who has the resources and desire to conduct clinical investigations, should be able to become involved in the process. The task of starting a new investigative unit is daunting, as it involves acquiring studies, hiring staff and obtaining space prior to any cash flow. If done properly, however, clinical investigation can be rewarding--both intellectually and financially.

[Clinical and genetic study patients with tuberous sclerosis complex].

PubMed

Rubilar, Carla; López, Francisca; Troncoso, Mónica; Barrios, Andrés; Herrera, Luisa

2017-02-01

Tuberous sclerosis complex (TSC) is a multisystem autosomal dominant disease caused by mutations in the tumor suppressor genes TSC1 or TSC2. To characterize clinically and genetically patients diagnosed with TSC. Descriptive study of clinical records of 42 patients from a pediatric neuropsychiatry department diagnosed with TSC and genetic study in 21 of them. The exon 15 of TSC1 gene and exons 33, 36 and 37 of TSC2 gene were amplified by polymerase chain reaction and sequenced. The relationship between the mutations found with the severity and clinical course were analyzed. In 61.9% of the patients the symptoms began before 6 months of age. The initial most frequent manifestations of TSC were new onset of seizures (73.8%) and the detection of cardiac rhabdomyomas (16.6%). During the evolution of the disease all patients had neurological involvement; 92.9% had epilepsy. All patients presented hypomelanotic spots, 47.6% facial angiofibromas, 23.8% Shagreen patch, 47.6 heart rhabdomyomas and 35.7% retinal hamartomas. In the genetic study of 21 patients two heterozygous pathogenic mutations in TSC1 and one in TSC2 genes were identified. The latter had a more severe clinical phenotype. Neurological and dermatological manifestations were the most frequent ones in patients with TSC. Two pathogenic mutations in TSC1 and one in TSC2 genes were identified. The patient with TSC2 mutation manifested a more severe clinical phenotype.

Dental Implants – Perceiving Patients’ Satisfaction in Relation to Clinical and Electromyography Study on Implant Patients

PubMed Central

Saha, Soumendra

2015-01-01

The aim of this study is to evaluate the satisfaction of patients with posterior implants in relation to the clinical success criteria and surface electromyography (sEMG) findings of the masseter and temporalis muscles. Total 42 subjects were investigated. Twenty one subjects with posterior dental implants were interviewed using a questionnaire and the clinical success criteria were determined based on The International Congress of Oral Implantologists. The myofunction of the masticatory muscles were assessed using sEMG (21 subjects) and compared to the control group of subjects without implants (21 subjects). Out of 21 subjects, all were satisfied with the aesthetics of their implant. Twenty of them (95.2%) were satisfied with its function and stability. As for clinical criteria, 100% (50) of the implants were successful with no pain, mobility or exudates. sEMG findings showed that patients have significantly lower (p<0.01) basal or resting median power frequency but with muscle burst. During chewing, control subjects showed faster chewing action. There was no difference in reaction and recovery time of clenching for both groups. In conclusion, the satisfaction of implant patients was high, and which was in relation to the successful clinical success criteria and sEMG findings. PMID:26465146

Determinants of successful clinical networks: the conceptual framework and study protocol.

PubMed

Haines, Mary; Brown, Bernadette; Craig, Jonathan; D'Este, Catherine; Elliott, Elizabeth; Klineberg, Emily; McInnes, Elizabeth; Middleton, Sandy; Paul, Christine; Redman, Sally; Yano, Elizabeth M

2012-03-13

Clinical networks are increasingly being viewed as an important strategy for increasing evidence-based practice and improving models of care, but success is variable and characteristics of networks with high impact are uncertain. This study takes advantage of the variability in the functioning and outcomes of networks supported by the Australian New South Wales (NSW) Agency for Clinical Innovation's non-mandatory model of clinical networks to investigate the factors that contribute to the success of clinical networks. The objective of this retrospective study is to examine the association between external support, organisational and program factors, and indicators of success among 19 clinical networks over a three-year period (2006-2008). The outcomes (health impact, system impact, programs implemented, engagement, user perception, and financial leverage) and explanatory factors will be collected using a web-based survey, interviews, and record review. An independent expert panel will provide judgements about the impact or extent of each network's initiatives on health and system impacts. The ratings of the expert panel will be the outcome used in multivariable analyses. Following the rating of network success, a qualitative study will be conducted to provide a more in-depth examination of the most successful networks. This is the first study to combine quantitative and qualitative methods to examine the factors that contribute to the success of clinical networks and, more generally, is the largest study of clinical networks undertaken. The adaptation of expert panel methods to rate the impacts of networks is the methodological innovation of this study. The proposed project will identify the conditions that should be established or encouraged by agencies developing clinical networks and will be of immediate use in forming strategies and programs to maximise the effectiveness of such networks.

Food for Thought Look Back in Anger – What Clinical Studies Tell Us About Preclinical Work

PubMed Central

Hartung, Thomas

2013-01-01

Summary Misled by animal studies and basic research? Whenever we take a closer look at the outcome of clinical trials in a field such as, most recently, stroke or septic shock, we see how limited the value of our preclinical models was. For all indications, 95% of drugs that enter clinical trials do not make it to the market, despite all promise of the (animal) models used to develop them. Drug development has started already to decrease its reliance on animal models: In Europe, for example, despite increasing R&D expenditure, animal use by pharmaceutical companies dropped by more than 25% from 2005 to 2008. In vitro studies are likewise limited: questionable cell authenticity, over-passaging, mycoplasma infections, and lack of differentiation as well as non-homeostatic and non-physiologic culture conditions endanger the relevance of these models. The standards of statistics and reporting often are poor, further impairing reliability. Alarming studies from industry show miserable reproducibility of landmark studies. This paper discusses factors contributing to the lack of reproducibility and relevance of pre-clinical research. The conclusion: Publish less but of better quality and do not rely on the face value of animal studies. PMID:23861075

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

PubMed

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

2017-01-12

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

Clinical trial registration in physical therapy journals: a cross-sectional study.

PubMed

Babu, Abraham Samuel; Veluswamy, Sundar Kumar; Rao, Pratiksha Tilak; Maiya, Arun G

2014-01-01

Clinical trial registration has become an important part of editorial policies of various biomedical journals, including a few physical therapy journals. However, the extent to which editorial boards enforce the need for trial registration varies across journals. The purpose of this study was to identify editorial policies and reporting of trial registration details in MEDLINE-indexed English-language physical therapy journals. This study was carried out using a cross-sectional design. Editorial policies on trial registration of MEDLINE-indexed member journals of the International Society of Physiotherapy Journal Editors (ISPJE) (Journal of Geriatric Physical Therapy, Journal of Hand Therapy, Journal of Neurologic Physical Therapy, Journal of Orthopaedic and Sports Physical Therapy, Journal of Physiotherapy [formerly Australian Journal of Physiotherapy], Journal of Science and Medicine in Sport, Manual Therapy, Physical Therapy, Physical Therapy in Sport, Physiotherapy, Physiotherapy Research International, Physiotherapy Theory and Practice, and Revista Brasileira de Fisioterapia) were reviewed in April 2013. Full texts of reports of clinical trials published in these journals between January 1, 2008, and December 31, 2012, were independently assessed for information on trial registration. Among the 13 journals, 8 recommended trial registration, and 6 emphasized prospective trial registration. As of April 2013, 4,618 articles were published between January 2008 and December 2012, of which 9% (417) were clinical trials and 29% (121/417) of these reported trial registration details. A positive trend in reporting of trial registration was observed from 2008 to 2012. The study was limited to MEDLINE-indexed ISPJE member journals. Editorial policies on trial registration of physical therapy journals and a rising trend toward reporting of trial registration details indicate a positive momentum toward trial registration. Physical therapy journal editors need to show

The role of the nurse teacher in clinical practice: an empirical study of Finnish student nurse experiences.

PubMed

Saarikoski, Mikko; Warne, Tony; Kaila, Päivi; Leino-Kilpi, Helena

2009-08-01

This paper focuses on the role of the nurse teacher (NT) in supporting student nurse education in clinical practice. The paper draws on the outcomes of a study aimed at exploring student nurse experiences of the pedagogical relationship with NTs during their clinical placements. The participants (N=549) were student nurses studying on pre-registration nursing programmes in Finland. Data were analysed using descriptive statistics, cross-tabulation and ANOVA. The study showed that the core aspect of NTs work in clinical practice revolved around the relationship between student, mentor and NT. Higher levels of satisfaction were experienced in direct proportion to the number of meetings held between the student and NT. However, whilst the importance of this relationship has been reported elsewhere, an additional aspect of this relationship emerged in the data analysis. Those NT who facilitated good face to face contact also used other methods to enhance the relationship, particularly e-mail, virtual learning environment and texting. This outcome suggests that NT's interpersonal and communicative skills are as important as their clinical knowledge and skills in promoting effective learning in the clinical practice area. The paper argues for such approaches to be utilised within the emergent opportunities afforded by new communication and educational technologies.

[Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases].

PubMed

Uchida, Eriko; Igarashi, Yuka; Sato, Yoji

2014-01-01

Gene therapy products are expected as innovative medicinal products for intractable diseases such as life-threatening genetic diseases and cancer. Recently, clinical developments by pharmaceutical companies are accelerated in Europe and the United States, and the first gene therapy product in advanced countries was approved for marketing authorization by the European Commission in 2012. On the other hand, more than 40 clinical studies for gene therapy have been completed or ongoing in Japan, most of them are conducted as clinical researches by academic institutes, and few clinical trials have been conducted for approval of gene therapy products. In order to promote the development of gene therapy products, revision of the current guideline and/or preparation of concept paper to address the evaluation of the quality and safety of gene therapy products are necessary and desired to clearly show what data should be submitted before First-in-Human clinical trials of novel gene therapy products. We started collaborative study with academia and regulatory agency to promote regulatory science toward clinical development of gene therapy products for genetic diseases based on lentivirus and adeno-associated virus vectors; National Center for Child Health and Development (NCCHD), Nippon Medical School and PMDA have been joined in the task force. At first, we are preparing pre-draft of the revision of the current gene therapy guidelines in this project.

Impact of clinical pharmacist intervention in anticoagulation clinic in Sudan.

PubMed

Ahmed, Nahid Osman; Osman, Bashier; Abdelhai, Yassein Mohamed; El-Hadiyah, Tariq Muhammed Hashim

2017-08-01

Background Many trials have compared anticoagulation management provided by a pharmacist led anticoagulation clinic versus usual physician care showing the role for clinical pharmacist in the management of anticoagulant therapy, and demonstrating excellent outcomes. In Sudan, there is no published research evaluating the role of pharmacist in providing pharmaceutical care for patients taking warfarin. Objective The objective of the study is to assess the role of clinical pharmacist intervention in warfarin patients compared to usual medical care. Setting This study was conducted in Ahmed Gasim cardiac surgery and renal transplant center warfarin clinic. Methods One hundred thirty-five patients were randomly selected from adult patients on warfarin therapy The history of INR records, and adverse effects for the past year, were recorded. Then patients' warfarin dose adjustments according to INR, was done by the clinical pharmacist for one year. Patients received continuous verbal education and written information about warfarin. Main outcome measure The primary outcome for this study was the INR control, while the secondary outcomes were the bleeding events and hospitalization due to warfarin. Results After the clinical pharmacist intervention there was significant (P < 0.01) improvement in INR control and a significant (P < 0.05) reduction in incidence of bleeding after clinical pharmacist intervention. Hospitalization due to warfarin related complications (bleeding, high INR, low INR) was also significantly (P < 0.001) reduced. Conclusion Clinical pharmacists intervention in warfarin therapy improve INR control, reduce bleeding and hospitalization due to warfarin complications.

Kidney volume measurement methods for clinical studies on autosomal dominant polycystic kidney disease

PubMed Central

Sharma, Kanishka; Caroli, Anna; Quach, Le Van; Petzold, Katja; Bozzetto, Michela; Serra, Andreas L.; Remuzzi, Giuseppe; Remuzzi, Andrea

2017-01-01

Background In autosomal dominant polycystic kidney disease (ADPKD), total kidney volume (TKV) is regarded as an important biomarker of disease progression and different methods are available to assess kidney volume. The purpose of this study was to identify the most efficient kidney volume computation method to be used in clinical studies evaluating the effectiveness of treatments on ADPKD progression. Methods and findings We measured single kidney volume (SKV) on two series of MR and CT images from clinical studies on ADPKD (experimental dataset) by two independent operators (expert and beginner), twice, using all of the available methods: polyline manual tracing (reference method), free-hand manual tracing, semi-automatic tracing, Stereology, Mid-slice and Ellipsoid method. Additionally, the expert operator also measured the kidney length. We compared different methods for reproducibility, accuracy, precision, and time required. In addition, we performed a validation study to evaluate the sensitivity of these methods to detect the between-treatment group difference in TKV change over one year, using MR images from a previous clinical study. Reproducibility was higher on CT than MR for all methods, being highest for manual and semiautomatic contouring methods (planimetry). On MR, planimetry showed highest accuracy and precision, while on CT accuracy and precision of both planimetry and Stereology methods were comparable. Mid-slice and Ellipsoid method, as well as kidney length were fast but provided only a rough estimate of kidney volume. The results of the validation study indicated that planimetry and Stereology allow using an importantly lower number of patients to detect changes in kidney volume induced by drug treatment as compared to other methods. Conclusions Planimetry should be preferred over fast and simplified methods for accurately monitoring ADPKD progression and assessing drug treatment effects. Expert operators, especially on MR images, are required

Impact of health portal enrollment with email reminders on adherence to clinic appointments: a pilot study.

PubMed

Horvath, Monica; Levy, Janet; L'Engle, Pete; Carlson, Boyd; Ahmad, Asif; Ferranti, Jeffrey

2011-05-26

Internet portal technologies that provide access to portions of electronic health records have the potential to revolutionize patients' involvement in their care. However, relatively few descriptions of the demographic characteristics of portal enrollees or of the effects of portal technology on quality outcomes exist. This study examined data from patients who attended one of seven Duke Medicine clinics and who were offered the option of enrolling in and using the Duke Medicine HealthView portal (HVP). The HVP allows patients to manage details of their appointment scheduling and provides automated email appointment reminders in addition to the telephone and mail reminders that all patients receive. Our objective was to test whether portal enrollment with an email reminder functionality is significantly related to decreases in rates of appointment "no-shows," which are known to impair clinic operational efficiency. Appointment activity during a 1-year period was examined for all patients attending one of seven Duke Medicine clinics. Patients were categorized as portal enrollees or as nonusers either by their status at time of appointment or at the end of the 1-year period. Demographic characteristics and no-show rates among these groups were compared. A binomial logistic regression model was constructed to measure the adjusted impact of HVP enrollment on no-show rates, given confounding factors. To demonstrate the effect of HVP use over time, monthly no-show rates were calculated for patient appointment keeping and contrasted between preportal and postportal deployment periods. Across seven clinics, 58,942 patients, 15.7% (9239/58,942) of whom were portal enrollees, scheduled 198,199 appointments with an overall no-show rate of 9.9% (19,668/198,199). We found that HVP enrollees were significantly more likely to be female, white, and privately insured compared with nonusers. Bivariate no-show rate differences between portal enrollment groups varied widely according

Non-invasive detection of periodontal disease using diffuse reflectance spectroscopy: a clinical study

NASA Astrophysics Data System (ADS)

Prasanth, Chandra Sekhar; Betsy, Joseph; Subhash, Narayanan; Jayanthi, Jayaraj L.; Prasanthila, Janam

2012-03-01

In clinical diagnostic procedures, gingival inflammation is considered as the initial stage of periodontal breakdown. This is often detected clinically by bleeding on probing as it is an objective measure of inflammation. Since conventional diagnostic procedures have several inherent drawbacks, development of novel non-invasive diagnostic techniques assumes significance. This clinical study was carried out in 15 healthy volunteers and 25 patients to demonstrate the applicability of diffuse reflectance (DR) spectroscopy for quantification and discrimination of various stages of inflammatory conditions in periodontal disease. The DR spectra of diseased lesions recorded using a point monitoring system consisting of a tungsten halogen lamp and a fiber-optic spectrometer showed oxygenated hemoglobin absorption dips at 545 and 575 nm. Mean DR spectra on normalization shows marked differences between healthy and different stages of gingival inflammation. Among the various DR intensity ratios investigated, involving oxy Hb absorption peaks, the R620/R575 ratio was found to be a good parameter of gingival inflammation. In order to screen the entire diseased area and its surroundings instantaneously, DR images were recorded with an EMCCD camera at 620 and 575 nm. We have observed that using the DR image intensity ratio R620/R575 mild inflammatory tissues could be discriminated from healthy with a sensitivity of 92% and specificity of 93%, and from moderate with a sensitivity of 83% and specificity of 96%. The sensitivity and specificity obtained between moderate and severe inflammation are 82% and 76% respectively.

[Learning in clinical simulation: observational study on satisfaction perceived by students of nursing].

PubMed

Rubbi, Ivan; Ferri, Paola; Andreina, Giulia; Cremonini, Valeria

2016-01-01

Simulation in the context of the educational workshop is becoming an important learning method, as it allows to play realistic clinical-care situations. These vocational training activities promote the development of cognitive, affective and psychomotor skills in a pedagogical context safe and risk-free, but need to be accounted for using by valid and reliable instruments. To inspect the level of satisfaction of the students of a Degree in Nursing in northern Italy about static and high-fidelity exercises with simulators and clinical cases. A prospective observational study has been conducted involving a non-probabili- stic sample of 51 third-year students throughout the academic year 2013/14. The data collection instrument consists of three questionnaires Student Satisfaction and Self-confidence in Learning Scale, Educational Practices Questionnaire, Simulation Design Scale and 3 questions on overall satisfaction. Statistical analysis was performed with SPSS 20.0 and Office 2003 Excel. The response rate of 89.5% is obtained. The Cronbach Alfa showed a good internal reliability (α = .982). The students were generally satisfied with the activities carried out in the teaching laboratory, showing more enthusiasm for the simulation with static mannequins (71%) and with high-fidelity simulators (60%), activities for which they have experienced a significant involvement and active learning. The teaching with clinical cases scored a lesser degree of satisfaction (38%) and for this method it was found the largest number of elements of weakness.

Bringing antiretroviral therapy (ART) closer to the end-user through mobile clinics and home-based ART: systematic review shows more evidence on the effectiveness and cost effectiveness is needed.

PubMed

Mdege, Noreen Dadirai; Chindove, Stanley

2014-01-01

Home-based antiretroviral therapy (ART) and ART through mobile clinics can potentially increase access to ART for large numbers of people, including hard-to-reach populations. We reviewed literature on the effectiveness and cost implications of the home-based ART and mobile clinic ART models. We searched Medline, Embase, PsycInfo, CINAHL, Cochrane Library, Web of Knowledge and Current Controlled Trials Register for articles published up to March 2012. We included non-randomised and randomised controlled clinical trials that recruited HIV/AIDS positive adults with or without prior exposure to ART. Six studies were included in the review, with only four effectiveness studies (all evaluating home-based ART and none for mobile clinic ART) and four studies reporting on the cost implications. The evidence suggests home-based ART is as effective as health facility-based ART, including on clinical outcomes, viral load and CD4+ count. However, three of these studies were very small. Studies suggest health facility-based ART is the most cost-effective, followed by mobile-clinic ART, with home-based ART being the least cost-effective. Evidence on the effectiveness and cost implications of mobile clinic and home-based ART is currently limited. Although the few available studies suggest home-based ART can potentially be as effective as health facility-based ART, there is need for more research before robust conclusions can be made. Results from the few available studies also suggest that health facility-based ART is the most cost-effective. Copyright © 2013 John Wiley & Sons, Ltd.

Evidenced-based review of clinical studies on periodontics.

PubMed

2009-08-01

Periodontal diseases have several implications for the practice of endodontics. First, advanced periodontitis often has direct implications for the long-term prognosis of the case and requires careful evaluation and coordinated treatment of both the periodontic and endodontic diseases. Second, the potential for functional interactions between odontogenic pathoses and marginal periodontitis requires careful collection of clinical observations and monitoring the outcome of various treatments. In this section, we provide an analysis of recent clinical studies in this area.

Clinical mastitis in ewes; bacteriology, epidemiology and clinical features.

PubMed

Mørk, Tormod; Waage, Steinar; Tollersrud, Tore; Kvitle, Bjørg; Sviland, Ståle

2007-09-24

Clinical mastitis is an important disease in sheep. The objective of this work was to identify causal bacteria and study certain epidemiological and clinical features of clinical mastitis in ewes kept for meat and wool production. The study included 509 ewes with clinical mastitis from 353 flocks located in 14 of the 19 counties in Norway. Clinical examination and collection of udder secretions were carried out by veterinarians. Pulsed-field gel electrophoresis (PFGE) was performed on 92 Staphylococcus aureus isolates from 64 ewes. S. aureus was recovered from 65.3% of 547 clinically affected mammary glands, coagulase-negative staphylococci from 2.9%, enterobacteria, mainly Escherichia coli, from 7.3%, Streptococcus spp. from 4.6%, Mannheimia haemolytica from 1.8% and various other bacteria from 4.9%, while no bacteria were cultured from 13.2% of the samples. Forty percent of the ewes with unilateral clinical S. aureus mastitis also had a subclinical S. aureus infection in the other mammary gland. Twenty-four of 28 (86%) pairs of S. aureus isolates obtained from clinically and subclinically affected mammary glands of the same ewe were indistinguishable by PFGE. The number of identical pairs was significantly greater than expected, based on the distribution of different S. aureus types within the flocks. One-third of the cases occurred during the first week after lambing, while a second peak was observed in the third week of lactation. Gangrene was present in 8.8% of the clinically affected glands; S. aureus was recovered from 72.9%, Clostridium perfringens from 6.3% and E. coli from 6.3% of the secretions from such glands. This study shows that S. aureus predominates as a cause of clinical ovine mastitis in Norway, also in very severe cases. Results also indicate that S. aureus is frequently spread between udder halves of infected ewes.

Anticancer Activity of Curcumin and Its Analogues: Preclinical and Clinical Studies.

PubMed

Allegra, Alessandro; Innao, Vanessa; Russo, Sabina; Gerace, Demetrio; Alonci, Andrea; Musolino, Caterina

2017-01-02

Curcumin has been shown to have a wide variety of therapeutic effects, ranging from anti-inflammatory, chemopreventive, anti-proliferative, and anti-metastatic. This review provides an overview of the recent research conducted to overcome the problems with the bioavailability of curcumin, and of the preclinical and clinical studies that have reported success in combinatorial strategies coupling curcumin with other treatments. Research on the signaling pathways that curcumin treatment targets shows that it potently acts on major intracellular components involved in key processes such as genomic modulations, cell invasion and cell death pathways. Curcumin is a promising molecule for the prevention and treatment of cancer.

Classification of Clinical Research Study Eligibility Criteria to Support Multi-Stage Cohort Identification Using Clinical Data Repositories.

PubMed

Cimino, James J; Lancaster, William J; Wyatt, Mathew C

2017-01-01

One of the challenges to using electronic health record (EHR) repositories for research is the difficulty mapping study subject eligibility criteria to the query capabilities of the repository. We sought to characterize criteria as "easy" (searchable in a typical repository), "hard" (requiring manual review of the record data), and "impossible" (not typically available in EHR repositories). We obtained 292 criteria from 20 studies available from Clinical Trials.gov and rated them according to our three types, plus a fourth "mixed" type. We had good agreement among three independent reviewers and chose 274 criteria that were characterized by single types for further analysis. The resulting analysis showed typical features of criteria that do and don't map to repositories. We propose that these features be used to guide researchers in specifying eligibility criteria to improve development of enrollment workflow, including the definition of EHR repository queries for self-service or analyst-mediated retrievals.

Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

PubMed

Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

2014-01-01

This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

Acellular dermal matrix allograft. The results of controlled randomized clinical studies.

PubMed

Novaes, Arthur Belém; de Barros, Raquel Rezende Martins

2008-10-01

The aim of this presentation was to discuss the effectiveness of the acellular dermal matrix in root coverage therapy and in alveolar ridge augmentation, based on three controlled randomized clinical trials conducted by our research team (Novaes Jr et al., 2001; Barros et al., 2005; Luczyszyn et al., 2005). The first and second studies highlight the allograft's performance in the treatment of gingival recession. In both studies, clinical parameters were assessed prior to surgery and 6 or 12 months post-surgery. The first one compared the use of the acellular dermal matrix with the subepithelial connective tissue graft and showed 1.83 and 2.10 mm of recession reduction, respectively. Because no statistically significant differences between the groups were observed, it was concluded that the allograft can be used as a substitute for the autograft. In the second study, a new surgical approach was compared to a conventional surgical procedure described by Langer and Langer in 1985. A statistically significant greater recession reduction favoring the test procedure was achieved. The percentage of root coverage was 82.5% and 62.3% for test and control groups. Thus the new technique was considered more suitable for the treatment of gingival recessions with the allograft. Finally, the third study evaluated the allograft as a membrane, associated or not with a resorbable hydroxyapatite in bone regeneration to prevent ridge deformities. In one group the extraction sockets were covered only by the allograft and in the other, the alveoli were also filled with the resorbable hydroxyapatite. After six months, both treatments were able to preserve ridge thickness, considering the pre-operative values. In conclusion, no adverse healing events were noted with the use of allograft in site preservation procedures, and sites treated with the combination of allograft plus resorbable hydroxyapatite showed significantly greater ridge thickness preservation at six months when compared to

Evaluation of the clinical process in a critical care information system using the Lean method: a case study

PubMed Central

2012-01-01

Background There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy. PMID:23259846

Evaluation of the clinical process in a critical care information system using the Lean method: a case study.

PubMed

Yusof, Maryati Mohd; Khodambashi, Soudabeh; Mokhtar, Ariffin Marzuki

2012-12-21

There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

Importance of population-based studies in clinical practice

PubMed Central

Ronnie, George; Ve, Ramesh Sathyamangalam; Velumuri, Lokapavani; Asokan, Rashima; Vijaya, Lingam

2011-01-01

In the last decade, there have been reports on the prevalence of glaucoma from the Vellore Eye Survey, Andhra Pradesh Eye Diseases Survey, Aravind Comprehensive Eye Survey, Chennai Glaucoma Study and West Bengal Glaucoma Study. Population-based studies provide important information regarding the prevalence and risk factors for glaucoma. They also highlight regional differences in the prevalence of various types of glaucoma. It is possible to gather important insights regarding the number of persons affected with glaucoma and the proportion with undiagnosed disease. We reviewed the different population-based studies from India and compare their findings. The lacunae in ophthalmic care that can be inferred from these studies are identified and possible reasons and solutions are discussed. We also discuss the clinical relevance of the various findings, and how it reflects on clinical practice in the country. Since India has a significantly high disease burden, we examine the possibility of population-based screening for disease in the Indian context. PMID:21150021

Clinical effectiveness of a cognitive behavioral group treatment program for anxiety disorders: a benchmarking study.

PubMed

Oei, Tian P S; Boschen, Mark J

2009-10-01

Previous research has established efficacy of cognitive behavioral therapy (CBT) for anxiety disorders, yet it has not been widely assessed in routine community clinic practices. Efficacy research sacrifices external validity to achieve maximum internal validity. Recently, effectiveness research has been advocated as more ecologically valid for assessing routine clinical work in community clinics. Furthermore, there is a lack of effectiveness research in group CBT. This study aims to extend existing research on the effectiveness of CBT from individual therapy into group therapy delivery. It aimed also to examine outcome using not only symptom measures, but also measures of related symptoms, cognitions, and life quality and satisfaction. Results from a cohort of patients with various anxiety disorders demonstrated that treatment was effective in reducing anxiety symptoms to an extent comparable with other effectiveness studies. Despite this, only 43% of individuals showed reliable change, and 17% were 'recovered' from their anxiety symptoms, and the post-treatment measures were still significantly different from the level of anxiety symptoms observed in the general population.

Challenges in evaluating clinical governance systems in iran: a qualitative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-04-01

In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead.

The clinical features of angular cheilitis occurring during orthodontic treatment: a multi-centre observational study.

PubMed

Cross, David; Eide, May L; Kotinas, Anastasios

2010-06-01

To report the prevalence and clinical features of angular cheilitis occurring in patients undergoing orthodontic treatment. Cross-sectional, observational study. Three centres were involved; Glasgow Dental Hospital and two specialist orthodontic practices, one in Scotland and one in Greece. Six hundred and sixty consecutive patients undergoing orthodontic treatment were examined over a 9 month period. The presence and absence of angular cheilitis was recorded. A six-point clinical scale was used to describe the clinical features of angular cheilitis when present. Chi-squared tests were used to investigate the association between the presence of angular cheilitis and oral hygiene level/appliance type. Eleven per cent of orthodontic patients in this Western European population, showed signs of angular cheilitis. No correlation was found between the presence of angular cheilitis and gender. Good oral hygiene was associated with a reduced prevalence (P<0.01). Angular cheilitis is a multifactorial condition that can occur in a small percentage of patients during orthodontic treatment. Good oral hygiene may be associated with a reduced risk. A new clinical grade of angular cheilitis is suggested that may help future research. Further studies are required to investigate the microbiological features associated with angular cheilitis occurring in orthodontic patients, as well as associations with medical conditions, such as asthma.

[Hypnosis for anxiety and phobic disorders: A review of clinical studies].

PubMed

Pelissolo, Antoine

2016-03-01

Hypnosis is classically presented as a useful psychotherapy for various psychiatric conditions, especially in the field of stress and anxiety. However, its place in therapeutic of chronic anxiety disorders remains unclear and questioned. Thus, the goal of this systematic review was to analyse the papers reporting clinical data on the efficacy of hypnosis in anxiety disorders. A literature search was conducted on Pubmed to retrieve all original papers, published between 1980 and 2015, reporting clinical information on the efficacy of hypnosis in six categories of anxiety disorders. Each paper has been assessed from a methodological point of view, and the results have been analysed. Only three controlled studies have been identified, one in panic disorder and two in post-traumatic stress disorder (PTSD). The other papers related open-design studies (4 articles), or single case reports (20 articles). The controlled study conducted in panic disorder suggested that the combination of hypnosis with cognitive-behavior therapy was not an effective strategy, and this negative result was also obtained in one of the studies conducted in PTSD. The third study, including 48 Indonesian children with PTSD, showed a significant improvement with a specific hypnosis technique adapted to the local culture. Other papers related also positive results but in non-controlled studies or in case reports, their conclusions cannot be generalized. To date, evidence is negative or insufficient to support the efficacy of hypnosis in chronic anxiety disorders, in any categories whatsoever - including phobia or PTSD. Specific further studies are needed to identify some potential profiles predictive of response to hypnosis in these conditions. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Early discharge of patients with pulmonary embolism in daily clinical practice: A prospective observational study comparing clinical gestalt and clinical rules.

PubMed

Vanni, Simone; Becattini, Cecilia; Nazerian, Peiman; Bova, Carlo; Stefanone, Valerio Teodoro; Cimini, Ludovica Anna; Viviani, Gabriele; Caviglioli, Cosimo; Sanna, Michela; Pepe, Giuseppe; Grifoni, Stefano

2018-05-08

To estimate the efficiency and safety of clinicians' gestalt in the identification of patients with pulmonary embolism (PE) candidates for early discharge and to compare the efficiency and safety of clinical gestalt with that of the Pulmonary Embolism Severity Index (PESI), the simplified PESI (sPESI) and the Hestia criteria (HC). Consecutive adult patients presenting to the emergency department of four Italian hospitals with confirmed diagnosis of PE were included. Data for PESI, sPESI and HC assessment were prospectively collected. Patients were managed according to the clinical gestalt of the attending physician, independent of the results of PESI, sPESI and HC. Efficiency was defined as the prevalence of candidates to early discharge. The primary safety measure was the incidence of a composite of venous thromboembolic recurrence, major haemorrhage or all-cause mortality within 30 days. Out of 547 included patients, 178 (32.5%) were judged to be at low risk and discharged within 48 h from presentation. HC identified a higher proportion (41.7%) whereas both PESI (24.1%) and sPESI (18.3%) identified a lower proportion of candidates for early discharge when compared to clinical gestalt (P < 0.01 for all). The incidence of the safety outcome was 2.8% in early-discharged patients according to clinical gestalt and 2.3%, 3.0% and 2.6% in candidates to early discharge according to PESI, sPESI and HC, without differences between strategies. In our cohort, clinical gestalt identified one-third of PE patients for early discharge. Among different strategies HC showed the highest efficiency sharing similar safety with the other strategies. Copyright © 2018 Elsevier Ltd. All rights reserved.

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

[Fundamental and clinical studies on ceftazidime in the field of pediatrics].

PubMed

Iwai, N; Sasaki, A; Taneda, Y; Shibata, M; Mizoguchi, F; Nakamura, H

1984-03-01

Fundamental and clinical studies were carried out on ceftazidime ( CAZ ), a new cephalosporin, in the field of pediatrics. 1. Antimicrobial activity MICs of CAZ were determined for clinical isolates of 24 strains of S. aureus, 15 of S. pyogenes, 8 of H. influenzae, 22 of E. coli, 20 of K. pneumoniae, 18 of P. mirabilis, 3 of P. morganii, and 21 of P. aeruginosa, and compared with those of the control drugs, i.e. CEZ, CXM, CMZ, CTX, LMOX and CMX. For P. aeruginosa, CPM, CFS and GM were also employed as the control drugs. CAZ was as active as CTX, LMOX and CMX, its MICs distributing in the range not higher than 0.10 microgram/ml for H. influenzae, 0.78 microgram/ml for E. coli, 0.39 microgram/ml for K. pneumoniae, 0.10 microgram/ml for P. mirabilis, and 0.10 microgram/ml for P. morganii in all the strains. Against P. aeruginosa, CAZ showed MICs in the range between 0.39 and 3.13 micrograms /ml, which showed activity higher than that of CTX, LMOX , CPM, CMX and GM, and comparable to that of CFS. Against S. pyogenes, CAZ was as active as all the control drugs except for LMOX , its MICs for all strains tested being 0.20 microgram/ml or below. Against S. aureus, CAZ was slightly more active than LMOX , but less active than the other control drugs, its MICs being relatively high ranging from 6.25 to 50 micrograms/ml. 2. Pharmacokinetics After a one-shot intravenous injection of CAZ 20 mg/kg, serum levels and urinary excretion were studied in 3 children aged 6 to 9 years, and CSF levels were determined in 2 children aged 6 to 7 years with aseptic meningitis. The mean serum levels of CAZ were 85.3 micrograms/ml at 1/4 hour, 53.3 micrograms/ml at 1/2 hour, 32.0 micrograms/ml at 1 hour, 16.1 micrograms/ml at 2 hours, 5.3 micrograms/ml at 4 hours, and 2.0 micrograms/ml at 6 hours, with the mean half-life of 1.18 hours. The mean urinary levels were 9,700 micrograms/ml at 0 to 2 hours, 803 micrograms/ml at 2 to 4 hours, 540 micrograms at 4 to 6 hours, and the mean urinary

Management of Chronic Periodontitis Using Chlorhexidine Chip and Diode Laser-A Clinical Study

PubMed Central

Ambooken, Majo; Mathew, Jayan Jacob; Issac, Annie Valayil; Kunju, Ajithkumar Parachalil; Parameshwaran, Renjith Athirkandathil

2016-01-01

Introduction The use of adjuncts like chlorhexidine local delivery and diode laser decontamination have been found to improve the clinical outcomes of scaling and root planing in non-surgical periodontal therapy in patients with chronic periodontitis. Aim To evaluate the effects of diode laser and chlorhexidine chip as adjuncts to scaling and root planing in the management of chronic periodontitis. The objective is to evaluate the outcome of chlorhexidine chip and diode laser as adjuncts to scaling and root planing on clinical parameters like Plaque Index, Gingival Index, probing pocket depth and clinical attachment level. Study and Design Department of Periodontics. Randomized clinical trial with split mouth design. Materials and Methods Fifteen chronic periodontitis patients having a probing pocket depth of 5mm-7mm on at least one interproximal site in each quadrant of the mouth were included in the study. After initial treatment, four sites in each patient were randomly subjected to scaling and root planing (control), chlorhexidine chip application (CHX chip group), diode laser (810 nm) decontamination (Diode laser group) or combination of both (Diode laser and chip group). Plaque Index (PI), Gingival Index (GI), probing pocket depth (PPD) and clinical attachment level (CAL) were assessed at baseline, one month and three months. Statistical analysis Results were statistically analysed using paired T test, one-way ANOVA, Tukey’s HSD test and repeated measure ANOVA. Results Post-treatment, the test and control sites showed a statistically significant reduction in PI, GI, PPD, and CAL. After three months, a mean PPD reduction of 1.47±0.52 mm in control group, 1.40±0.83 mm in diode laser group, 2.67±0.62 mm in CHX group, and 2.80± 0.77 mm in combination group was seen. The mean gain in CAL were 1.47±0.52 mm in the control group, 1.40±0.83 mm in diode laser group, 2.67± 0.49 mm in CHX group and 2.67± 0.82 mm in combination group respectively. The

Studying the Vendor Perspective on Clinical Decision Support

PubMed Central

Ash, Joan S.; Sittig, Dean F.; McMullen, Carmit K.; McCormack, James L.; Wright, Adam; Bunce, Arwen; Wasserman, Joseph; Mohan, Vishnu; Cohen, Deborah J.; Shapiro, Michael; Middleton, Blackford

2011-01-01

In prior work, using a Rapid Assessment Process (RAP), we have investigated clinical decision support (CDS) in ambulatory clinics and hospitals. We realized that individuals in these settings provide only one perspective related to the CDS landscape, which also includes content vendors and electronic health record (EHR) vendors. To discover content vendors’ perspectives and their perceived challenges, we modified RAP for industrial settings. We describe how we employed RAP, and show its utility by describing two illustrative themes. We found that while the content vendors believe they provide unique much-needed services, the amount of labor involved in content development is underestimated by others. We also found that the content vendors believe their products are resources to be used by practitioners, so they are somewhat protected from liability issues. To promote adequate understanding about these issues, we recommend a “three way conversation” among content vendors, EHR vendors, and user organizations. PMID:22195058

Drug administration in animal studies of cardiac arrest does not reflect human clinical experience

PubMed Central

Reynolds, Joshua C.; Rittenberger, Jon C.; Menegazzi, James J.

2007-01-01

Introduction To date, there is no evidence showing a benefit from any advanced cardiac life support (ACLS) medication in out-of-hospital cardiac arrest (OOHCA), despite animal data to the contrary. One explanation may be a difference in the time to first drug administration. Our previous work has shown the mean time to first drug administration in clinical trials is 19.4 minutes. We hypothesized that the average time to drug administration in large animal experiments occurs earlier than in OOHCA clinical trials. Methods We conducted a literature review between 1990 and 2006 in MEDLINE using the following MeSH headings: swine, dogs, resuscitation, heart arrest, EMS, EMT, ambulance, ventricular fibrillation, drug therapy, epinephrine, vasopressin, amiodarone, lidocaine, magnesium, and sodium bicarbonate. We reviewed the abstracts of 331 studies and 197 full manuscripts. Exclusion criteria included: non-peer reviewed, all without primary animal data, and traumatic models. From these, we identified 119 papers that contained unique information on time to medication administration. The data are reported as mean, ranges, and 95% confidence intervals. Mean time to first drug administration in animal laboratory studies and clinical trials was compared with a t-test. Regression analysis was performed to determine if time to drug predicted ROSC. Results Mean time to first drug administration in 2378 animals was 9.5 minutes (range 3.0–28.0; 95% CI around mean 2.78, 16.22). This is less than the time reported in clinical trials (19.4 min, p<0.001). Time to drug predicted ROSC (Odds Ratio 0.844; 95% CI 0.738, 0.966). Conclusion Shorter drug delivery time in animal models of cardiac arrest may be one reason for the failure of animal studies to translate successfully into the clinical arena. PMID:17360097

Combined Clinic-Home Approach for Upper Limb Robotic Therapy After Stroke: A Pilot Study.

PubMed

Kim, Grace J; Rivera, Lisa; Stein, Joel

2015-12-01

To investigate the feasibility of a combined clinic-home intervention using a robotic elbow brace and, secondarily, to collect preliminary data on the efficacy of this clinic-home intervention. Nonrandomized pre-/postinterventional study. Outpatient clinic and participants' homes. Individuals at least 6 months after stroke (N=11; 5 women and 6 men; mean age, 51.7y; mean time since stroke, 7.6y; mean Fugl-Meyer Assessment of the Upper Extremity [FMA-UE] score, 22 of 66) were enrolled from the community. Participants received training in an outpatient clinic from an experienced occupational therapist to gain independence with use of the device (3-9 sessions) followed by a 6-week home program using the device at home. Five instruments were administered before and after the study intervention: Modified Ashworth Scale, Box and Blocks test, FMA-UE, Arm Motor Ability Test, and Motor Activity Log-Amount of Use and Motor Activity Log-How Well subscales (MAL-AOU, MAL-HW). Nine participants completed the study. Participants used the device on average 42.9min/d, 5.3d/wk. The FMA-UE (t=3.32; P=.01), MAL-AOU (t=4.40; P=.002), and MAL-HW (t=4.02; P=.004) scores showed statistically significant improvement from baseline to discharge; the MAL-AOU (t=2.61; P=.035) and MAL-HW (t=2.47; P=.043) scores were also significantly improved from baseline to 3-month follow-up. This combined clinic-home intervention was feasible and effective. Participants demonstrated improvements in arm impairment and self-reported use of the arm from baseline to discharge; they continued to report significant improvement in actual use of the arm at 3-month follow-up. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A retrospective study of dermatitis herpetiformis from an immunobullous disease clinic in north India.

PubMed

Handa, Sanjeev; Dabas, Garima; De, Dipankar; Mahajan, Rahul; Chatterjee, Debajyoti; Saika, Uma N; Radotra, Bishan D

2018-05-11

Indian data on dermatitis herpetiformis (DH) is not available. The aim of this study was to investigate the demographic and clinicopathological characteristics of patients with DH and to study its association with other autoimmune diseases. All data were collected from case record forms of patients registered in immunobullous disease clinic of our institute. The diagnosis was based on characteristic clinical and immuno/histopathological features. A total of 65 patients were included, which constituted 9.47% of the registered patients in the immunobullous disease clinic over 3.5 years. The male to female ratio was 1.4 : 1; the average age was 44.35 ± 15.52 years. Direct immunofluorescence showed granular IgA deposits at the papillary tips in 83.07% and basement membrane zone in 12.3% patients. Sixteen (24.1%) patients had associated celiac disease, and 15 (23.07%) patients had other autoimmune comorbidities such as hypothyroidism. Forty percent of patients on strict gluten-free diet achieved remission in 2 years, while 35.4% had frequent relapses as they continued gluten intake. Dermatitis herpetiformis is not a rare disease in northern India as previously believed. The clinical, histological, and immunopathological characteristics of Indian DH patients are similar to those reported in Caucasian populations. The limitations of our study include an absence of genetic testing for HLA-DQ2 or DQ8, nonavailability of kits for detecting IgA specific for epidermal transglutaminase (IgA eTG), and short follow-up period. © 2018 The International Society of Dermatology.

Clinical and Para Clinical Information Needs of Infertility Electronic Health Records in Iran: A Delphi Study.

PubMed

Farzandipour, Mehrdad; Jeddi, Fateme Rangraz; Gilasi, Hamid Reza; Shirzadi, Diana

2017-09-01

infertility is referred to the person's inability to conceive pregnancy after one year of intercourse without using protection. This study paves the ground for creating a complete, united, and coherent source of patients' medical information. this is an applied research of descriptive-cross sectional type which has been carried out through qualitative - quantitative methods. The sample of the present study was 50 specialists in the field of infertility which has been chosen based on purposive sampling method. Designing the questionnaire was done based on library studies and Gathering experts' views was done based on Delphi technique. 261 items from clinical and Para clinical information of infertile patients' electronic health records were subjected to an opinion poll by experts. During this process 223 items were accepted and 38 items have been rejected after two sessions of surveys by infertility experts. Para clinical information section consisted of 57 items that all of them have been accepted by the experts. Also, clinical information section consisted of 242 items from which 204 items were accepted and 38 items were rejected by the experts. existence of a structured electronic record system of infertile patients' information leads to the integration of patients' information, improvement of health care services and a decrease in treatment costs: all working to increase information safety. Furthermore, only essential and relevant information would be provided for the specialists and it will facilitate and direct the future infertility related studies due to the coherence, unity and relevance of the information.

Thermographic diagnostics to discriminate skin lesions: a clinical study

NASA Astrophysics Data System (ADS)

Stringasci, Mirian Denise; Moriyama, Lilian Tan; Salvio, Ana Gabriela; Bagnato, Vanderlei Salvador; Kurachi, Cristina

2015-06-01

Cancer is responsible for about 13% of all causes of death in the world. Over 7 million people die annually of this disease. In most cases, the survival rates are greater when diagnosed in early stages. It is known that tumor lesions present a different temperature compared with the normal tissues. Some studies have been performed in an attempt to establish new diagnosis methods, targeting this temperature difference. In this study, we aim to investigate the use of a handheld thermographic camera to discriminate skin lesions. The patients presenting Basal Cell Carcinoma, Squamous Cell Carcinoma, Actinic Keratosis, Pigmented Seborrheic Keratosis, Melanoma or Intradermal Nevus lesions have been investigated at the Skin Departament of Amaral Carvalho Hospital. Patients are selected by a dermatologist, and the lesion images are recorded using an infrared camera. The images are evaluated taken into account the temperature level, and differences into lesion areas, borders, and between altered and normal skin. The present results show that thermography may be an important tool for aiding in the clinical diagnostics of superficial skin lesions.

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

PubMed Central

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

2009-01-01

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

[Primary breast lymphoma: a clinical, pathological and immunophenotypic study of eight cases].

PubMed

Ying, Jianming; Feng, Xiaoli; Liu, Xiuyun; Xie, Yongqiang; Sun, Yuntian

2002-12-01

To study the clinical, pathological and immunophenotypic characteristics of the primary breast lymphoma (PBL). Analyses of clinical history, preoperative findings, histological and immunohistochemical features of eight patients with PBL were performed. Malignant lymphoma was difficult to diagnose preoperatively. All patients were women. The age range was from 34 approximately 65 years (mean 46.4 years). The right breast was involved initially in three patients, the left in four. One patient presented bilateral involvement. Seven patients were assessed at stage IE, one with ipsolateral axillary lymph nodes involvement at stage IIE. According to the WHO classification, five patients were diagnosed as diffuse large B-cell lymphoma (4/5 centroblast, 1/5 immunoblast); the other three patients as MALT lymphoma, all with lymphoepithelial lesions. The paraffin-embedded tissues of all cases showed immunoreactivity for B-cell markers CD20, CD45RA. CD5 and CD10 were negative in all cases. Follow-up data were obtained in six patients, none recurred or died within 8 to 108 months after diagnosis. This study indicates that most PBL are diffuse large B-cell lymphoma and MALT lymphoma and have a better prognosis after comprehensive therapy.

Clinical and Radiological Profile of Acute Fibrinous and Organizing Pneumonia: A Retrospective Study.

PubMed

Dai, Jing-Hong; Li, Hui; Shen, Wei; Miao, Li-Yun; Xiao, Yong-Long; Huang, Mei; Cao, Meng-Shu; Wang, Yang; Zhu, Bin; Meng, Fan-Qing; Cai, Hou-Rong

2015-10-20

Acute fibrinous and organizing pneumonia (AFOP) is a unique pathological entity with intra-alveolar fibrin in the form of "fibrin balls" and organizing pneumonia. It was divided into rare idiopathic interstitial pneumonia according to the classification notified by American Thoracic Society/European Respiratory Society in 2013. As a rare pathological entity, it is still not well known and recognized by clinicians. We reviewed the clinical features of 20 patients with AFOP diagnosed in a teaching hospital. The medical records of 20 patients with biopsy-proven diagnosis of AFOP were retrospectively reviewed. The patients' symptoms, duration of the disease, comorbidities, clinical laboratory data, pulmonary function testing, radiographic studies, and the response to treatment were extracted and analyzed. Fever was the most common symptom and was manifested in 90% of AFOP patients. For clinical laboratory findings, systematic inflammatory indicators, including C-reactive protein and erythrocyte sedimentation rate, were significantly higher than normal in AFOP patients. In accordance with this increased indicators, injured liver functions were common in AFOP patients. Inversely, AFOP patients had worse clinical conditions including anemia and hypoalbuminemia. For pulmonary function testing, AFOP patients showed the pattern of restrictive mixed with obstructive ventilation dysfunction. For high-resolution computerized tomography (HRCT) findings, the most common pattern for AFOP patients was lobar consolidation which was very similar to pneumonia. However, unlike pneumonia, AFOP patients responded well to glucocorticoids. Patients with AFOP manifest as acute inflammatory-like clinical laboratory parameters and lobar consolidation on HRCT, but respond well to steroid.

Challenges in Evaluating Clinical Governance Systems in Iran: A Qualitative Study

PubMed Central

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Background: In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. Objectives: This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. Materials and Methods: For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Results: Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Conclusions: Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead. PMID:24910799

The Clinical Research Center for Depression Study: Baseline Characteristics of a Korean Long-Term Hospital-Based Observational Collaborative Prospective Cohort Study

PubMed Central

Kim, Tae-Suk; Jeong, Seung Hee; Kim, Jung-Bum; Lee, Min-Soo; Kim, Jae-Min; Yim, Hyeon-Woo

2011-01-01

Objective The Clinical Research Center for Depression (CRESCEND) study is a 9-year observational collaborative prospective cohort study for the clinical outcomes in participants with depressive disorders in Korea. In this study, we examined the baseline characteristics of the depressive participants as the hospital-based cohort. Methods Participants were assessed using various instruments including the Clinical Global Impression scale, 17-item Hamilton Depression Rating Scale (HDRS-17), Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, Social and Occupational Functioning Assessment Scale, Beck Depression Inventory-Second Edition, Scale for Suicide Ideation, and World Health Organization Quality of Life assessment instruments-abbreviated version. Also, personal histories of medical and psychiatric illnesses and the range of socio-epidemiologic and clinical data were collected from each participant. Results One thousand one hundred eighty three participants were recruited from 18 hospitals. The mean age of the participants was 47.9±15.9 year-old, 74.4% were female, 82.9% had been diagnosed of major depressive disorder, 40.9% were experiencing their first depressive episode, and 21.4% had a past history of suicide attempts. The majority (85.3%) of the participants were moderately to severely ill. The average HDRS-17 was 19.8±6.1. Significant gender differences at baseline were shown in age, education, marriage, employment, religion, and first depressive episode. Conclusion The baseline findings in the CRESCEND study showed some different characteristics of depression in Korea, suggesting a possibility of ethnic and cultural factors in depression. PMID:21519530

[Laboratory and clinical study of intravenous miconazole].

PubMed

Sawae, Y; Okada, K; Kumagai, Y

1987-02-01

Laboratory and clinical study was carried out on miconazole (MCZ), a new synthetic imidazole. The antifungal activity of MCZ was studied and expressed as MICs for clinical isolates. The drug proved to have the highest activity against Cryptococcus neoformans, with MICs of no more than 0.16 micrograms/ml for all isolates of this species. MICs of Torulopsis glabrata were 0.08-5 micrograms/ml for all isolates and those of Candida albicans and Candida tropicalis were 5-20 micrograms/ml for more than 90% of the isolates. Most of other strains were less than 10 micrograms/ml. When 3 healthy adult men were administered each with 200 mg of MCZ by intravenous drip infusion for 1.25 hours, the mean serum MCZ concentration was 1.39 micrograms/ml at the end of the infusion, then decreased rapidly to 0.49 microgram/ml in following 30 minutes, and then decreased gradually to 0.17 microgram/ml 6 hours later. The mean cumulative urinary excretion rate of the drug was as low as 3.0% at this stage. A total of 25 patients with ages of 30-78 years, comprising 17 men and 8 women, were treated with 200-1,800 mg of MCZ daily for 3-93 days. The clinical effectiveness was ascertained in 19 cases among the patients; 9 cases with candidiasis, 3 with cryptococcosis and 7 with aspergillosis. Clinical responses were excellent in 2, good in 9 and poor in 8 cases, and its efficacy rates was 58%. The efficacy rate of the combination therapy with other antifungal agents was 60% in comparison with 57% of MCZ alone. Adverse reactions to the drug such as nausea, vomiting and anorexia were observed in 3 cases (12%). Abnormal changes in laboratory parameters were also observed: 3 patients with elevations of GOT and GPT, and another with eosinophilia.

Enrichment of clinical study populations.

PubMed

Temple, R

2010-12-01

Those who conduct clinical trials "enrich" study populations in a variety of ways in order to identify a population of patients in whom a drug effect, if present, is more likely to be demonstrable. The principal ways to do this are as follows: (i) practical enrichment, i.e., generally seeking to reduce noise (variability of measurement) and heterogeneity (by avoiding the enrollment of patients with other diseases and individuals in whom the disease disappears spontaneously), (ii) prognostic enrichment, i.e., finding patients who are likely to have the event of interest when enrolling for risk-reduction studies, and (iii) predictive enrichment, i.e., finding the individuals who are more likely to respond. Enrichment fits well into the growing interest in "individualization" of therapy but creates some tension with another trend, namely, the desire for "real-world studies" with less restrictive entry criteria and other requirements.

Recommendations for Planning Pilot Studies in Clinical and Translational Research

PubMed Central

Moore, Charity G.; Carter, Rickey E.; Nietert, Paul J.; Stewart, Paul W.

2011-01-01

Abstract  Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase “pilot study” is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well‐designed pilot studies play in the advancement of science and scientific careers. Clin Trans Sci 2011; Volume 4: 332–337 PMID:22029804

Recommendations for conducting controlled clinical studies of dental restorative materials.

PubMed

Hickel, R; Roulet, J-F; Bayne, S; Heintze, S D; Mjör, I A; Peters, M; Rousson, V; Randall, R; Schmalz, G; Tyas, M; Vanherle, G

2007-03-01

About 35 years ago, Ryge provided a practical approach to evaluation of clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and non-standard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to meaningfully interpret. In many cases, the insensitivity of the original Ryge methods is misinterpreted as good clinical performance. While there are many good features of the original system, it is now time to move to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial

3D Printing Surgical Implants at the clinic: A Experimental Study on Anterior Cruciate Ligament Reconstruction

PubMed Central

Liu, An; Xue, Guang-huai; Sun, Miao; Shao, Hui-feng; Ma, Chi-yuan; Gao, Qing; Gou, Zhong-ru; Yan, Shi-gui; Liu, Yan-ming; He, Yong

2016-01-01

Desktop three-dimensional (3D) printers (D3DPs) have become a popular tool for fabricating personalized consumer products, favored for low cost, easy operation, and other advantageous qualities. This study focused on the potential for using D3DPs to successfully, rapidly, and economically print customized implants at medical clinics. An experiment was conducted on a D3DP-printed anterior cruciate ligament surgical implant using a rabbit model. A well-defined, orthogonal, porous PLA screw-like scaffold was printed, then coated with hydroxyapatite (HA) to improve its osteoconductivity. As an internal fixation as well as an ideal cell delivery system, the osteogenic scaffold loaded with mesenchymal stem cells (MSCs) were evaluated through both in vitro and in vivo tests to observe bone-ligament healing via cell therapy. The MSCs suspended in Pluronic F-127 hydrogel on PLA/HA screw-like scaffold showed the highest cell proliferation and osteogenesis in vitro. In vivo assessment of rabbit anterior cruciate ligament models for 4 and 12 weeks showed that the PLA/HA screw-like scaffold loaded with MSCs suspended in Pluronic F-127 hydrogel exhibited significant bone ingrowth and bone-graft interface formation within the bone tunnel. Overall, the results of this study demonstrate that fabricating surgical implants at the clinic (fab@clinic) with D3DPs can be feasible, effective, and economical. PMID:26875826

Actigraphy in Human African Trypanosomiasis as a Tool for Objective Clinical Evaluation and Monitoring: A Pilot Study

PubMed Central

Njamnshi, Alfred K.; Seke Etet, Paul F.; Perrig, Stephen; Acho, Alphonse; Funsah, Julius Y.; Mumba, Dieudonné; Muyembe, Jean-Jacques; Kristensson, Krister; Bentivoglio, Marina

2012-01-01

Background Human African trypanosomiasis (HAT) or sleeping sickness leads to a complex neuropsychiatric syndrome with characteristic sleep alterations. Current division into a first, hemolymphatic stage and second, meningoencephalitic stage is primarily based on the detection of white blood cells and/or trypanosomes in the cerebrospinal fluid. The validity of this criterion is, however, debated, and novel laboratory biomarkers are under study. Objective clinical HAT evaluation and monitoring is therefore needed. Polysomnography has effectively documented sleep-wake disturbances during HAT, but could be difficult to apply as routine technology in field work. The non-invasive, cost-effective technique of actigraphy has been widely validated as a tool for the ambulatory evaluation of sleep disturbances. In this pilot study, actigraphy was applied to the clinical assessment of HAT patients. Methods/Principal Findings Actigraphy was recorded in patients infected by Trypanosoma brucei gambiense, and age- and sex-matched control subjects. Simultaneous nocturnal polysomnography was also performed in the patients. Nine patients, including one child, were analyzed at admission and two of them also during specific treatment. Parameters, analyzed with user-friendly software, included sleep time evaluated from rest-activity signals, rest-activity rhythm waveform and characteristics. The findings showed sleep-wake alterations of various degrees of severity, which in some patients did not parallel white blood cell counts in the cerebrospinal fluid. Actigraphic recording also showed improvement of the analyzed parameters after treatment initiation. Nocturnal polysomnography showed alterations of sleep time closely corresponding to those derived from actigraphy. Conclusions/Significance The data indicate that actigraphy can be an interesting tool for HAT evaluation, providing valuable clinical information through simple technology, well suited also for long-term follow

Nursing students' viewpoints toward two methods of clinical conference and clinical nursing round.

PubMed

Gheidanzadeh, Maryam; Baghersad, Zahra; Abazari, Parvaneh

2017-01-01

Clinical education provides a chance to combine theoretical knowledge and clinical skills. Students are the key elements in the evaluation of clinical education efficacy. The present study was aimed to define nursing students' viewpoints concerning conformity to the characteristics of clinical conference and clinical round. This descriptive analytical study was conducted on the bachelor's students of the 4 th -6 th semester of nursing. Sampling was conducted using census sampling method during the 2 nd semester of 2014-2015 school year. Data collection tool was a three-section researcher-made questionnaire containing demographic, nursing round, and clinical conference characteristics. Descriptive and inferential statistical tests (independent t -test, ANOVA, and Spearman and Pearson correlation coefficients) were used for data analysis. Participants were 134 bachelor's students of the 4 th -6 th semester of nursing. According to half of the participants, conformity to the characteristics of clinical conference (45.5%, 53%) and clinical round (44%, 51.5%) were poor and medium, respectively. Paired t -test showed a significant difference between students' viewpoints toward the planning of clinical conference and clinical nursing round ( P = 0.006, t = 2.77). According to the results of the present study on students' viewpoints, clinical education faces a serious challenge with regard to clinical education methods. Considering the necessity and importance of clinical education, more investigation should be conducted to detect its relevant factors and plan for its improvement.

Epidemiology of symptoms of dry eye disease (DED) in Jordan: A cross-sectional non-clinical population-based study.

PubMed

Bakkar, May M; Shihadeh, Wisam A; Haddad, Mera F; Khader, Yousef S

2016-06-01

To describe the prevalence of dry eye disease (DED) symptoms and to identify associated risk factors in a general non-clinical population in Jordan. In this cross-sectional study, participants were selected randomly from the general non-clinical population in Jordan. Participants aged 18 years or over completed the Arabic version of Ocular Surface Disease Index (OSDI) questionnaire on dry eye symptoms. The OSDI questionnaire was completed by 1039 subjects (609 female and 430 male). The mean OSDI score for the study population was 27, with 59% of subjects showed OSDI score ≥20 (a cut off score for mild DED symptoms). Females showed significantly higher mean OSDI score than males in the older age group (p=0.01). The prevalence of all dryness symptoms was markedly reported in older age group >45 years and contact lens wearers (p<0.05). The most commonly reported DED symptom was sensitivity to light and intense symptoms were markedly reported during windy conditions. Vision-related quality of life was also affected in subjects with dryness symptoms. Working with computers and ATM was among those that highly affected. The results show that symptoms of dry eye were prevalent in this non-clinical population. Contact lenses wear and older age were found to be associated with dry eye symptoms. Copyright © 2015 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

Clinical reasoning in nursing, a think-aloud study using virtual patients - a base for an innovative assessment.

PubMed

Forsberg, Elenita; Ziegert, Kristina; Hult, Håkan; Fors, Uno

2014-04-01

In health-care education, it is important to assess the competencies that are essential for the professional role. To develop clinical reasoning skills is crucial for nursing practice and therefore an important learning outcome in nursing education programmes. Virtual patients (VPs) are interactive computer simulations of real-life clinical scenarios and have been suggested for use not only for learning, but also for assessment of clinical reasoning. The aim of this study was to investigate how experienced paediatric nurses reason regarding complex VP cases and how they make clinical decisions. The study was also aimed to give information about possible issues that should be assessed in clinical reasoning exams for post-graduate students in diploma specialist paediatric nursing education. The information from this study is believed to be of high value when developing scoring and grading models for a VP-based examination for the specialist diploma in paediatric nursing education. Using the think-aloud method, data were collected from 30 RNs working in Swedish paediatric departments, and child or school health-care centres. Content analysis was used to analyse the data. The results indicate that experienced nurses try to consolidate their hypotheses by seeing a pattern and judging the value of signs, symptoms, physical examinations, laboratory tests and radiology. They show high specific competence but earlier experience of similar cases was also of importance for the decision making. The nurses thought it was an innovative assessment focusing on clinical reasoning and clinical decision making. They thought it was an enjoyable way to be assessed and that all three main issues could be assessed using VPs. In conclusion, VPs seem to be a possible model for assessing the clinical reasoning process and clinical decision making, but how to score and grade such exams needs further research. © 2013.

Unattended Sleep Studies in a VA Population: Initial Evaluation by Chart Review Versus Clinic Visit by a Midlevel Provider.

PubMed

Alsharif, Abdelhamid M; Potts, Michelle; Laws, Regina; Freire, Amado X; Sultan-Ali, Ibrahim

2016-10-01

Obstructive sleep apnea (OSA) is a prevalent disorder that is associated with multiple medical consequences. Although in-laboratory polysomnography is the gold standard for the diagnosis of OSA, portable monitors have been developed and studied to help increase efficiency and ease of diagnosis. We aimed to assess the adequacy of a midlevel provider specializing in sleep medicine to risk-stratify patients for OSA based on a chart review versus a comprehensive clinic evaluation before scheduling an unattended sleep study. This study was an observational, nonrandomized, retrospective data collection by chart review of patients accrued prospectively who underwent an unattended sleep study at the Sleep Health Center at the Memphis Veterans Affairs Medical Center during the first 13 months of the program (May 1, 2011-May 31, 2012). A total of 205 patients were included in the data analysis. Analysis showed no statistically significant differences between chart review and clinic visit groups ( P = 0.54) in terms of OSA diagnosis. Although not statistically significant, the analysis shows a trend toward higher mean age (50.3 vs 47.4 years; P = 0.10) and lower mean body mass index (34.4 vs 36.0; P = 0.08) in individuals who were evaluated during a comprehensive clinic visit. A statistically significant difference is seen in terms of the pretest clinical probability of OSA being moderate or high in 62.2% of patients in the clinic visit group and 95.7% in the chart review group, with a χ 2 P ≤ 0.0001. In the Veterans Health Administration's system, the assessment of pretest probability may be determined by a midlevel provider using chart review with equal efficacy to a comprehensive face-to-face evaluation in terms of OSA diagnosis via unattended sleep studies.

[Clinical studies on flomoxef in neonates].

PubMed

Tabuki, K; Nishimura, T

1993-07-01

Clinical studies on flomoxef (FMOX) were performed in neonates and the results obtained are summarized as follows. Treatment with FMOX was made in 4 cases of neonatal bacterial infections; 2 cases of sepsis (suspected) and 1 case each of infection of umbilicus and staphylococcal scalded skin syndrome. Results obtained were excellent in 1 case, good in 3 cases. No significant side effects due to the drug were observed in any cases.

Development and Evaluation of Reference Standards for Image-based Telemedicine Diagnosis and Clinical Research Studies in Ophthalmology

PubMed Central

Ryan, Michael C.; Ostmo, Susan; Jonas, Karyn; Berrocal, Audina; Drenser, Kimberly; Horowitz, Jason; Lee, Thomas C.; Simmons, Charles; Martinez-Castellanos, Maria-Ana; Chan, R.V. Paul; Chiang, Michael F.

2014-01-01

Information systems managing image-based data for telemedicine or clinical research applications require a reference standard representing the correct diagnosis. Accurate reference standards are difficult to establish because of imperfect agreement among physicians, and discrepancies between clinical vs. image-based diagnosis. This study is designed to describe the development and evaluation of reference standards for image-based diagnosis, which combine diagnostic impressions of multiple image readers with the actual clinical diagnoses. We show that agreement between image reading and clinical examinations was imperfect (689 [32%] discrepancies in 2148 image readings), as was inter-reader agreement (kappa 0.490-0.652). This was improved by establishing an image-based reference standard defined as the majority diagnosis given by three readers (13% discrepancies with image readers). It was further improved by establishing an overall reference standard that incorporated the clinical diagnosis (10% discrepancies with image readers). These principles of establishing reference standards may be applied to improve robustness of real-world systems supporting image-based diagnosis. PMID:25954463

Pre-clinical and Clinical Safety Studies of CMX-2043: A Cytoprotective Lipoic Acid Analogue for Ischaemia–Reperfusion Injury

PubMed Central

Kates, Steven A; Lader, Alan S; Casale, Ralph; Beeuwkes, Reinier

2014-01-01

CMX-2043 is an α-lipoic acid analogue targeted to reduction of cellular injury and organ damage due to ischaemia–reperfusion injury (IRI). It has been shown to be effective in a rat model of cardiac IRI. The studies here reported evaluate its safety and pharmacokinetic profile in preparation for human clinical studies in procedures associated with IRI. Safety and tolerability were tested in standard pre-clinical in vitro and animal models and in a Phase 1 human clinical trial. CMX-2043 did not bind to a wide range of receptors and specific targets at approximately 4 μg/mL (10 μM). It was not mutagenic by Ames assay, did not produce chromosome aberrations in Chinese hamster ovary (CHO) cells, and was negative for clastogenic potential. Toxicological studies in rats including both single and 14-day repeat intravenous doses and in dogs (single intravenous dose) with a 2-week recovery period were conducted. The NOAEL in rats and dogs was 30 and >10 mg/kg, respectively. No serious adverse events were reported in a placebo-controlled, sequential dose escalation Phase 1 clinical trial. The low toxicity in the pre-clinical studies and the absence of adverse events in the Phase 1 trial have supported investigation of CMX-2043 in a human efficacy trial. PMID:24751172

Using Theater to Teach Clinical Empathy: A Pilot Study

PubMed Central

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

2007-01-01

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

Standardization of Clinical Assessment and Sample Collection Across All PERCH Study Sites

PubMed Central

Prosperi, Christine; Baggett, Henry C.; Brooks, W. Abdullah; Deloria Knoll, Maria; Hammitt, Laura L.; Howie, Stephen R. C.; Kotloff, Karen L.; Levine, Orin S.; Madhi, Shabir A.; Murdoch, David R.; O’Brien, Katherine L.; Thea, Donald M.; Awori, Juliet O.; Bunthi, Charatdao; DeLuca, Andrea N.; Driscoll, Amanda J.; Ebruke, Bernard E.; Goswami, Doli; Hidgon, Melissa M.; Karron, Ruth A.; Kazungu, Sidi; Kourouma, Nana; Mackenzie, Grant; Moore, David P.; Mudau, Azwifari; Mwale, Magdalene; Nahar, Kamrun; Park, Daniel E.; Piralam, Barameht; Seidenberg, Phil; Sylla, Mamadou; Feikin, Daniel R.; Scott, J. Anthony G.; O’Brien, Katherine L.; Levine, Orin S.; Knoll, Maria Deloria; Feikin, Daniel R.; DeLuca, Andrea N.; Driscoll, Amanda J.; Fancourt, Nicholas; Fu, Wei; Hammitt, Laura L.; Higdon, Melissa M.; Kagucia, E. Wangeci; Karron, Ruth A.; Li, Mengying; Park, Daniel E.; Prosperi, Christine; Wu, Zhenke; Zeger, Scott L.; Watson, Nora L.; Crawley, Jane; Murdoch, David R.; Brooks, W. Abdullah; Endtz, Hubert P.; Zaman, Khalequ; Goswami, Doli; Hossain, Lokman; Jahan, Yasmin; Ashraf, Hasan; Howie, Stephen R. C.; Ebruke, Bernard E.; Antonio, Martin; McLellan, Jessica; Machuka, Eunice; Shamsul, Arifin; Zaman, Syed M.A.; Mackenzie, Grant; Scott, J. Anthony G.; Awori, Juliet O.; Morpeth, Susan C.; Kamau, Alice; Kazungu, Sidi; Kotloff, Karen L.; Tapia, Milagritos D.; Sow, Samba O.; Sylla, Mamadou; Tamboura, Boubou; Onwuchekwa, Uma; Kourouma, Nana; Toure, Aliou; Madhi, Shabir A.; Moore, David P.; Adrian, Peter V.; Baillie, Vicky L.; Kuwanda, Locadiah; Mudau, Azwifarwi; Groome, Michelle J.; Baggett, Henry C.; Thamthitiwat, Somsak; Maloney, Susan A.; Bunthi, Charatdao; Rhodes, Julia; Sawatwong, Pongpun; Akarasewi, Pasakorn; Thea, Donald M.; Mwananyanda, Lawrence; Chipeta, James; Seidenberg, Phil; Mwansa, James; wa Somwe, Somwe; Kwenda, Geoffrey

2017-01-01

Abstract Background. Variable adherence to standardized case definitions, clinical procedures, specimen collection techniques, and laboratory methods has complicated the interpretation of previous multicenter pneumonia etiology studies. To circumvent these problems, a program of clinical standardization was embedded in the Pneumonia Etiology Research for Child Health (PERCH) study. Methods. Between March 2011 and August 2013, standardized training on the PERCH case definition, clinical procedures, and collection of laboratory specimens was delivered to 331 clinical staff at 9 study sites in 7 countries (The Gambia, Kenya, Mali, South Africa, Zambia, Thailand, and Bangladesh), through 32 on-site courses and a training website. Staff competency was assessed throughout 24 months of enrollment with multiple-choice question (MCQ) examinations, a video quiz, and checklist evaluations of practical skills. Results. MCQ evaluation was confined to 158 clinical staff members who enrolled PERCH cases and controls, with scores obtained for >86% of eligible staff at each time-point. Median scores after baseline training were ≥80%, and improved by 10 percentage points with refresher training, with no significant intersite differences. Percentage agreement with the clinical trainer on the presence or absence of clinical signs on video clips was high (≥89%), with interobserver concordance being substantial to high (AC1 statistic, 0.62–0.82) for 5 of 6 signs assessed. Staff attained median scores of >90% in checklist evaluations of practical skills. Conclusions. Satisfactory clinical standardization was achieved within and across all PERCH sites, providing reassurance that any etiological or clinical differences observed across the study sites are true differences, and not attributable to differences in application of the clinical case definition, interpretation of clinical signs, or in techniques used for clinical measurements or specimen collection. PMID:28575355

Prevention or treatment of ARDS with aspirin: a review of preclinical models and meta- analysis of clinical studies

PubMed Central

Panka, Bernardo Amisa; de Grooth, Harm-Jan; Spoelstra–de Man, Angeliquè; Looney, Mark; Tuinman, Pieter-Roel

2016-01-01

Background The acute respiratory distress syndrome (ARDS) is a life-threating disorder that contributes significantly to critical illness. No specific pharmacological interventions directed at lung injury itself, have proven effective in improving outcome of patients with ARDS. Platelet activation was identified as a key component in ARDS pathophysiology and may provide an opportunity for preventive and therapeutic strategies. We hypothesize that use of acetyl salicylic acid (ASA) may prevent and/or attenuate lung injury. Methods We conducted a systematic review of preclinical studies and meta-analysis of clinical studies investigating the efficacy of ASA in the setting of lung injury. MEDLINE, EMBASE AND COCHRANE databases were searched. Results The literature search yielded 1314 unique articles. Fifteen pre-clinical studies and eight clinical studies fulfilled the in- and exclusion criteria. In the animal studies, the overall effect of ASA was positive, e.g. ASA improved survival and attenuated inflammation and pulmonary edema. Mechanisms of actions involved, among others, are interference with the neutrophil-platelets interaction, reduction of leukotrienes, neutrophil extracellular traps and prostaglandins. High dose ASA may be the drug of choice. A meta-analysis of 3 clinical studies showed an association between ASA use and a reduced incidence of ARDS (OR 0.59, 95% CI 0.36–0.98), albeit with substantial between-study heterogeneity. All studies had their own shortcomings in methodological quality. Conclusion This systematic review of preclinical studies and meta-analysis of clinical studies suggests a beneficial role for ASA in ARDS prevention and treatment. However, the currently available data is insufficient to justify an indication for ASA in ARDS. The body of literature does support further studies in humans. We suggest clinical trials in which the mechanisms of action of ASA in lung injury models is being evaluated to guide optimal timing and dose

What does physicians' clinical expertise contribute to oncologic decision-making? A qualitative interview study.

PubMed

Salloch, Sabine; Otte, Ina; Reinacher-Schick, Anke; Vollmann, Jochen

2018-02-01

Physicians' clinical expertise forms an exclusive body of competences, which helps them to find the appropriate diagnostics and treatment for each individual patient. Empirical evidence, however, suggests that there is an inverse relationship between the number of years in practice and the quality of care provided by a physician. Knowledge and adherence to professional standards (such as clinical guidelines) are often used as indicators in previous research. Semistructured interviews and the Q method were used for an explorative study on oncologists' views on the interplay between their own clinical expertise, intuition, and the external evidence incorporated in clinical guidelines. The interviews were audio recorded, transcribed ad verbatim, and analysed using qualitative content analysis. Data analysis shows the complex character of clinical expertise with respect to experience, professional development, and intuition. An irreplaceable role is attributed to personal and bodily experience during the providing of care for a patient. Professional experience becomes important, particularly in those situations that lie out of the focus of "guideline medicine." Intuition is regarded as having a strong emotional component and helps for deciding which therapeutic option the patient can deal with. Using measurable knowledge and adherence to standards as indicators does not account for the complexity of clinical expertise. Other factors, such as the importance of bodily experience and physicians' intuitive knowledge, must be considered, also with respect to the occurrence of treatment biases. © 2017 John Wiley & Sons, Ltd.

Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases

PubMed Central

Li, Xue-Lin; Tang, Jin-Fa; Li, Wei-Xia; Li, Chun-Xiao; Zhao, Tao; Zhao, Bu-Chang; Wang, Yong; Zhang, Hui; Chen, Xiao-Fei; Xu, Tao; Zhu, Ming-Jun

2015-01-01

Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved. PMID:26508981

[Descriptive study of ambulatory blood pressure monitoring in the Primary Care Nursing clinic].

PubMed

Garzón-Quiñones, Marina; Gallardo-Gonzalo, Cristina; Padín-Minaya, Cristina; López-Pisa, Rosa M; Rodríguez-Latre, Luisa M

2013-01-01

To analyze the clinical characteristics and the circadian patterns of patients who received ambulatory blood pressure monitoring (ABPM) by a Primary Care Team. A descriptive, observational, cross-sectional study at community level. People older than 18 years on ABPM (2007-2011). demographic, cardiovascular disease, diabetes mellitus, cardiovascular risk factors, any type of arterial hypertension and circadian pattern. Intruments of measurement: 2 validated instruments with comparable results were used. The instruments for ABPM were placed during the nursing visit. The instruments were then removed after 24h, and the data was retrieved and recorded in the computerized clinical history. A total of 326 people were studied, with a mean age of 60.53±12.96 years, of whom 56.7% were male. According to ABPM the patient results showed that: 38.5% had «white coat» arterial hypertension, 36.2% were classified as poorly controlled arterial hypertension, 17.2% had masked hypertension, and 8% with isolated hypertension. Dipper circadian patterns were present in 39.6% of patients and non- dipper in 60.4%. ABPM allows to Primary Health Care professionals to check the actual situation of the blood pressure over 24h and analyze the circadian pattern. In clinical practice this involves having a comprehensive care strategy on life style, as well as adherence to treatment. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers.

PubMed

Yoshita, Tomohiro; Uchida, Shinya; Namiki, Noriyuki

2013-01-01

Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; p<0.001). This study shows that all the tested products, which are clinically available in Japan, showed good disintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity.

Different femorotibial contact points between fixed- and mobile-bearing TKAs do not show clinical impact.

PubMed

van Stralen, R A; Heesterbeek, P J C; Wymenga, A B

2015-11-01

In anteroposterior (AP)-gliding mobile-bearing total knee arthroplasty (TKA), the femoral component can theoretically slide forward resulting in a more anterior contact point, causing pain due to impingement. A lower lever arm of the extensor apparatus can also attribute to higher patella pressures and pain. The goal of this study was to determine the contact point in a cohort of mobile- and fixed-bearing TKAs, to determine whether the contact point lies more anteriorly in mobile-bearing TKA and to confirm whether this results in anterior knee pain. We used 38 fixed-bearing TKA and 40 mobile-bearing TKA from a randomized trial with straight lateral knee X-rays and measured the contact point. The functional outcome was measured by Knee Society Score at 12 months postoperatively. Pain scores were analysed using a VAS score (0-100 mm) in all patients at rest and when moving. Difficulty at rising up out of a chair was also assessed using a VAS score. The contact point in mobile-bearing TKA was situated at 59.5 % of the AP distance of the tibia and in the fixed-bearing TKA group at 66.1 % (P< 0.05). Patients with mobile- and fixed-bearing TKAs had similar knee scores, pain scores and difficulty in chair rise. No significant correlation was found between contact point and knee pain. The hypothesis of a more anterior contact point in the mobile-bearing cohort was confirmed but no correlation with functional and pain scores in this cohort could be found. The tibiofemoral contact point could not be correlated with a different clinical outcome and higher incidence of anterior knee pain. This study further adds to the knowledge on possible differences between mobile- and fixed-bearing prostheses. Next to that, bad outcomes could not be explained by CP. Case series, Level IV.

Patient safety culture in Norwegian primary care: a study in out-of-hours casualty clinics and GP practices.

PubMed

Bondevik, Gunnar Tschudi; Hofoss, Dag; Hansen, Elisabeth Holm; Deilkås, Ellen Catharina Tveter

2014-09-01

This study aimed to investigate patient safety attitudes amongst health care providers in Norwegian primary care by using the Safety Attitudes Questionnaire, in both out-of-hours (OOH) casualty clinics and GP practices. The questionnaire identifies five major patient safety factors: Teamwork climate, Safety climate, Job satisfaction, Perceptions of management, and Working conditions. Cross-sectional study. Statistical analysis included multiple linear regression and independent samples t-tests. Seven OOH casualty clinics and 17 GP practices in Norway. In October and November 2012, 510 primary health care providers working in OOH casualty clinics and GP practices (316 doctors and 194 nurses) were invited to participate anonymously. To study whether patterns in patient safety attitudes were related to professional background, gender, age, and clinical setting. The overall response rate was 52%; 72% of the nurses and 39% of the doctors answered the questionnaire. In the OOH clinics, nurses scored significantly higher than doctors on Safety climate and Job satisfaction. Older health care providers scored significantly higher than younger on Safety climate and Working conditions. In GP practices, male health professionals scored significantly higher than female on Teamwork climate, Safety climate, Perceptions of management and Working conditions. Health care providers in GP practices had significant higher mean scores on the factors Safety climate and Working conditions, compared with those working in the OOH clinics. Our study showed that nurses scored higher than doctors, older health professionals scored higher than younger, male GPs scored higher than female GPs, and health professionals in GP practices scored higher than those in OOH clinics - on several patient safety factors.

Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

PubMed

Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

2016-07-01

A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information. © The Author(s) 2015.

Experimental study showed that adding fortifier and extra-hydrolysed proteins to preterm infant mothers' milk increased osmolality.

PubMed

Rosas, R; Sanz, M P; Fernández-Calle, P; Alcaide, M J; Montes, M T; Pastrana, N; Segovia, C; Omeñaca, F; Sáenz de Pipaón, M

2016-12-01

Measuring milk osmolality after adjustable fortification is clinically relevant, as values exceeding recommended safety thresholds might result in gastrointestinal consequences. The aim of this study was to evaluate the effect of four fortification levels and storage time on the osmolality of human milk. This was an experimental study using 71 spare samples of fresh breastmilk collected from 31 mothers of preterm infants. Osmolality was measured before and after adding commercial human milk fortifier containing dextrinomaltose and hydrolysed proteins at four different concentrations. Measurements were performed at various points during the 23 hours after fortification. The mean basal osmolality of the 71 human milk samples was 296 ± 14 milliosmoles (mOsm)/kg, and these remained stable over a period of 23 hours. Just after fortification, the four fortified formulas showed higher osmolalities than the nonfortified human milk, ranging between 384 ± 14 and 486 ± 15 mOsm/kg, respectively (p < 0.01). This osmolality increased significantly from 20 minutes to 23 hours after fortification (p < 0.05). Adding fortifier and extra-hydrolysed proteins to human preterm milk increased osmolality, and these osmolality levels also increased with time. We recommend evaluating the risk of hyperosmolality when a higher fortification level is needed, to avoid gastrointestinal problems. ©2016 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Utility of an Equine Clinical Skills Course: A Pilot Study.

PubMed

Christensen, Bruce W; Danielson, Jared A

Recent publications have revealed inadequacies in the veterinary training of future equine practitioners. To help address this problem, a 2-week Equine Clinical Skills course was designed and implemented to provide fourth-year veterinary students with opportunities to have hands-on experience with common equine clinical skills using live animals and cadavers. Alumni and employers of alumni were surveyed to determine whether or not students participating in the course were more competent performing clinical skills during their first year post-graduation than those who had not participated in the course. Students who participated in the course were also surveyed before and after completing the course to determine whether or not their self-assessed skills improved during the course. Alumni who had taken the course rated their ability to perform the clinical skills more highly than alumni who had not taken the course. Similarly, students participating in the course indicated that they were significantly more able to perform the clinical skills after the course than when it began. Employers did not indicate a difference between the clinical skills of those who had taken the course and those who had not. Because this study involved a limited number of respondents from one institution, further studies should be conducted to replicate these findings and determine their generalizability.

[Clinical study of bladder injury].

PubMed

Abe, Kazuhiro; Oishi, Yukihiko; Onodera, Syoichi; Ikemoto, Isao; Kiyota, Hiroshi; Asano, Koji; Ueda, Masataka; Wada, Tetsuro; Tashiro, Kazuya

2002-03-01

Since bladder injury has no specific clinical symptoms, accurate diagnosis at first consultation is relatively difficult. To elucidate the clinical characters type of injury, clinical symptoms, laboratory findings, methods of therapy and diagnosis, we reviewed 15 patients with bladder injury over a 9-year-period 1990-1998 (10 were traumatic injuries and 5 spontaneous injuries). We found no specific clinical symptom of bladder injury. Bladder injury may occur anywhere in the bladder wall, but most commonly occurred at the dome of the bladder (60.0%). Gross hematuria was not seen in 40.0% of the cases. The accuracy of diagnosis at first consultation was relatively low (46.7%) and the tendency to make a misdiagnosis as acute abdomen on digestive organs was found. Of the traumatic injuries 60% were afflicted in the drunken state, so alcohol intoxication was considered as an important enviromental factor of bladder injury. Surgical repair of injury sites was employed in 11 cases (73.3%: 7 were intraperitoneal injuries, 4 were extraperitoneal injuries), 4 cases were managed with indwelling urethral catheter. With appropriate treatment, the prognosis is excellent.

Bacteriophages show promise as antimicrobial agents.

PubMed

Alisky, J; Iczkowski, K; Rapoport, A; Troitsky, N

1998-01-01

The emergence of antibiotic-resistant bacteria has prompted interest in alternatives to conventional drugs. One possible option is to use bacteriophages (phage) as antimicrobial agents. We have conducted a literature review of all Medline citations from 1966-1996 that dealt with the therapeutic use of phage. There were 27 papers from Poland, the Soviet Union, Britain and the U.S.A. The Polish and Soviets administered phage orally, topically or systemically to treat a wide variety of antibiotic-resistant pathogens in both adults and children. Infections included suppurative wound infections, gastroenteritis, sepsis, osteomyelitis, dermatitis, empyemas and pneumonia; pathogens included Staphylococcus, Streptococcus, Klebsiella, Escherichia, Proteus, Pseudomonas, Shigella and Salmonella spp. Overall, the Polish and Soviets reported success rates of 80-95% for phage therapy, with rare, reversible gastrointestinal or allergic side effects. However, efficacy of phage was determined almost exclusively by qualitative clinical assessment of patients, and details of dosages and clinical criteria were very sketchy. There were also six British reports describing controlled trials of phage in animal models (mice, guinea pigs and livestock), measuring survival rates and other objective criteria. All of the British studies raised phage against specific pathogens then used to create experimental infections. Demonstrable efficacy against Escherichia, Acinetobacter, Pseudomonas and Staphylococcus spp. was noted in these model systems. Two U.S. papers dealt with improving the bioavailability of phage. Phage is sequestered in the spleen and removed from circulation. This can be overcome by serial passage of phage through mice to isolate mutants that resist sequestration. In conclusion, bacteriophages may show promise for treating antibiotic resistant pathogens. To facilitate further progress, directions for future research are discussed and a directory of authors from the reviewed

47,XXX male: A clinical and molecular study.

PubMed

Ogata, T; Matsuo, M; Muroya, K; Koyama, Y; Fukutani, K

2001-02-01

We report a 53-year-old Japanese male with a 47,XXX karyotype. His clinical features included hypoplastic scrotal testes (4 ml bilaterally), normally formed small penis (3.8 cm), relatively poor pubic hair development (Tanner stage 3), gynecomastia, age-appropriate male height (159.1 cm), and mental retardation (verbal IQ of 56). Serum testosterone was markedly reduced (0.6 nmol/L). A needle biopsy showed severe testicular degeneration. FISH analysis revealed complex mosaicism consisting of (1) 47,XXX cells with a single copy of SRY (n = 177), two copies of SRY (n = 3), and no SRY (n = 1); (2) 46,XX cells with a single copy of SRY (n = 9) and no SRY (n = 3); (3) 45,X cells with no SRY (n = 5); and (4) 48,XXXX cells with a single copy of SRY (n = 1) and two copies of SRY (n = 1). PCR analysis showed the presence of Yp portion with the breakpoint between DYS264 and AMELY. Microsatellite analysis demonstrated three alleles for DMD and AR. X-inactivation analysis for the methylation status of the AR gene showed random inactivation of the three X chromosomes. The results suggest that this 47,XXX male has resulted from abnormal X-Y interchange during paternal meiosis and X-X nondisjunction during maternal meiosis. Complex mosaicism may be due to the age-related increase in mitotic nondisjunction which is prone to occur in rapidly dividing lymphocytes and to the presence of two randomly inactivated X chromosomes which may behave asynchronously during mitosis, and clinical features of this male would primarily be explained by the genetic information on the SRY (+) der(X) chromosome and his advanced age. Copyright 2001 Wiley-Liss, Inc.

The politics of nursing: a case study--clinical grading.

PubMed

Gavin, J N

1995-08-01

This paper is a study of the clinical grading policy for nurses in the United Kingdom and the extent to which the participating groups in the policy development process realized their objectives. The study is based on the literature available at the time of the research and the results of structured interviews with a range of individuals involved in the policy process. The results expose the cleavages between the different representative groups on the staff side. They also shed light on the differing power bases of the groups involved. In particular, they expose the weakness of nursing as a professional pressure group and the strength of the state and its agents in determining the outcomes of policy in the public arena. It is suggested that this weakness vis-à-vis the state is responsible for the failure of nurses to achieve a reward system which recognizes the value of clinical nursing expertise, and that the 'clinical grading' system, in practice, is having the opposite effect. The policy is explored from its origins, its acceptance on to the political agenda, its negotiation and agreement, its contentious implementation, the final outcomes, and its failure to establish a valid 'clinical' pay structure.

Impact of Health Portal Enrollment With Email Reminders on Adherence to Clinic Appointments: A Pilot Study

PubMed Central

Levy, Janet; L'Engle, Pete; Carlson, Boyd; Ahmad, Asif; Ferranti, Jeffrey

2011-01-01

Background Internet portal technologies that provide access to portions of electronic health records have the potential to revolutionize patients’ involvement in their care. However, relatively few descriptions of the demographic characteristics of portal enrollees or of the effects of portal technology on quality outcomes exist. This study examined data from patients who attended one of seven Duke Medicine clinics and who were offered the option of enrolling in and using the Duke Medicine HealthView portal (HVP). The HVP allows patients to manage details of their appointment scheduling and provides automated email appointment reminders in addition to the telephone and mail reminders that all patients receive. Objective Our objective was to test whether portal enrollment with an email reminder functionality is significantly related to decreases in rates of appointment “no-shows,” which are known to impair clinic operational efficiency. Methods Appointment activity during a 1-year period was examined for all patients attending one of seven Duke Medicine clinics. Patients were categorized as portal enrollees or as nonusers either by their status at time of appointment or at the end of the 1-year period. Demographic characteristics and no-show rates among these groups were compared. A binomial logistic regression model was constructed to measure the adjusted impact of HVP enrollment on no-show rates, given confounding factors. To demonstrate the effect of HVP use over time, monthly no-show rates were calculated for patient appointment keeping and contrasted between preportal and postportal deployment periods. Results Across seven clinics, 58,942 patients, 15.7% (9239/58,942) of whom were portal enrollees, scheduled 198,199 appointments with an overall no-show rate of 9.9% (19,668/198,199). We found that HVP enrollees were significantly more likely to be female, white, and privately insured compared with nonusers. Bivariate no-show rate differences between portal

Resveratrol and diabetes: A critical review of clinical studies.

PubMed

Öztürk, Ebru; Arslan, Ayşe Kübra Karaboğa; Yerer, Mükerrem Betül; Bishayee, Anupam

2017-11-01

Diabetes mellitus (DM) is a metabolic disease characterized by hyperglycemia. The disease results from the defects of insulin secretion and/or action. Resveratrol is a non-flavonoid polyphenol that naturally occurs as phytoalexin. The shell and stem of Vitis vinifera L. (Vitaceae) are the richest source of this compound. In addition to various in vitro and in vivo studies revealing the effectiveness of resveratrol in DM, there are many clinical trials indicating that resveratrol has the potential to benefit in DM patients. The therapeutic action of this compound in relation to diabetes is complex and involves in several beneficial roles. In view of this, clinical studies are necessary to elucidate these roles. In the near future, the use of resveratrol, alone or in combination with current anti-diabetic therapies, might be a conventional approach to effectively manage DM or its complications. This mini-review provides a critical overview of currently available clinical studies examining the effects of resveratrol in DM last decade. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Nutritional clinical studies in dermatology.

PubMed

Liakou, Aikaterini I; Theodorakis, Michael J; Melnik, Bodo C; Pappas, Apostolos; Zouboulis, Christos C

2013-10-01

Nutrition has long been associated with skin health, beauty, integrity and aging through multiple pathways and cofactors implicated in skin biology. The onset and clinical course of various common skin diseases, especially acne, psoriasis, atopic dermatitis, and hair loss, have been suggested to be critically affected by nutrition patterns and habits. The relationship between acne and diet, predominantly the role of high glycemic load diets and dairy consumption have recently gained increased interest. Abnormal nutritional conditions such as obesity or malnutrition often manifest themselves by specific cutaneous features and altered skin function. Skin photoprotection, rendered by various nutrients, is well documented and appropriate nutritional supplementation has been shown to exert beneficial effects upon impaired skin integrity, restore its appearance and promote skin health. It is our intention to provide a comprehensive review of the most recent information on the role of nutrition for common skin diseases and regulation of skin biology. Nutritional clinical studies in dermatology have been reviewed using the MedLine literature source and the terms "diet" or "nutrition" and "skin". The data on the relationship between nutrition and skin are until now controversial and much more work is needed to be done to clarify possible etiological correlations.

An open-label, 12-week clinical and sleep EEG study of nefazodone in chronic combat-related posttraumatic stress disorder.

PubMed

Gillin, J C; Smith-Vaniz, A; Schnierow, B; Rapaport, M H; Kelsoe, J; Raimo, E; Marler, M R; Goyette, L M; Stein, M B; Zisook, S

2001-10-01

We examined the effects of nefazodone on polysomnographic sleep measures and subjective reports of sleep quality and nightmares. as well as other symptoms, in patients with chronic combat-related posttraumatic stress disorder (PTSD) during a 12-week, open-label clinical trial. To our knowledge, this is the first polysomnographic study of treatment in patients with PTSD. The subjects were 12 male veterans (mean age = 54 years) who met DSM-IV diagnostic criteria for PTSD (mean duration = 30 years). All but I patient also met DSM-IV criteria for major depressive disorder. Patients were evaluated weekly with clinical ratings in an open-label clinical trial. Polysomnographic recordings for 2 consecutive nights were obtained before treatment and at 2, 4, 8, and 12 weeks. The dose of nefazodone was adjusted according to individual clinical needs. Final mean daily dose was 441 mg. The patients reported significantly fewer nightmares and sleep problems during treatment. Nevertheless, contrary to studies in depressed patients, nefazodone did not significantly affect polysomnographic sleep measures compared with baseline. In addition, the patients showed significant improvement in the Clinical Global Impressions of PTSD symptoms (global score, hyperarousals and intrusions subscales), the Clinician-Administered PTSD Scale (global, hyperarousal, and intrusions subscales), the Hamilton Rating Scale for Depression (HAM-D). and the Beck Depression Inventory (BDI). These patients with chronic, treatment-resistant, combat-related PTSD showed significant improvement of subjective symptoms of nightmares and sleep disturbance, as well as depression and PTSD symptoms. in this 12-week open-label clinical trial. Nevertheless, objective polysomnographic sleep measures did not change. Further studies, including double-blind. placebo-controlled trials, are needed to extend these findings and to understand the relationships between the physiology of sleep and symptoms of poor sleep and

Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study.

PubMed

Balsam, Paweł; Lodziński, Piotr; Tymińska, Agata; Ozierański, Krzysztof; Januszkiewicz, Łukasz; Główczyńska, Renata; Wesołowska, Katarzyna; Peller, Michał; Pietrzak, Radosław; Książczyk, Tomasz; Borodzicz, Sonia; Kołtowski, Łukasz; Borkowski, Mariusz; Werner, Bożena; Opolski, Grzegorz; Grabowski, Marcin

2018-01-01

Today, the main challenge for researchers is to develop new technologies which may help to improve the diagnoses of cardiovascular disease (CVD), thereby reducing healthcare costs and improving the quality of life for patients. This study aims to show the utility of biomedical shirt-based electrocardiography (ECG) monitoring of patients with CVD in different clinical situations using the Nuubo® ECG (nECG) system. An investigator-initiated, multicenter, prospective observational study was carried out in a cardiology (adult and pediatric) and cardiac rehabilitation wards. ECG monitoring was used with the biomedical shirt in the following four independent groups of patients: 1) 30 patients after pulmonary vein isolation (PVI), 2) 30 cardiac resynchronization therapy (CRT) recipients, 3) 120 patients during cardiac rehabilitation after myocardial infarction, and 4) 40 pediatric patients with supraventricular tachycardia (SVT) before electrophysiology study. Approval for all study groups was obtained from the institutional review board. The biomedical shirt captures the electrocardiographic signal via textile electrodes integrated into a garment. The software allows the visualization and analysis of data such as ECG, heart rate, arrhythmia detecting algorithm and relative position of the body is captured by an electronic device. The major advantages of the nECG system are continuous ECG monitoring during daily activities, high quality of ECG recordings, as well as assurance of a proper adherence due to adequate comfort while wearing the shirt. There are only a few studies that have examined wearable systems, especially in pediatric populations. This study is registered in ClinicalTrials.gov: Identifier NCT03068169. (Cardiol J 2018; 25, 1: 52-59).

Clinico-pathological study to evaluate oral lichen planus for the establishment of clinical and histopathological diagnostic criteria.

PubMed

Hiremath, Santhosh; Kale, Alka D; Hallikerimath, Seema

2015-01-01

Lichen planus and lichenoid lesions affecting the oral cavity show similar clinico-pathological features creating a diagnostic dilemma. Hence, the aim of the present study was to establish a clinical and histopathological correlation in the diagnosis of oral lichen planus, based on the modified WHO diagnostic criteria of oral lichen planus and oral lichenoid lesions proposed by Van der Meij and Van der Waal in 2003. In the present study, 100 cases of oral lichen planus were clinically and histopathologically analyzed. Out of the 100 cases, 50 were prospective and 50 were retrospective cases. Prospective cases were collected based on the clinical diagnosis of oral lichen planus and oral lichenoid lesion. Retrospective cases were collected based on the histopathological diagnosis of oral lichen planus. Both the clinical and histopathological analyses were performed based on a proposal for a set of modified diagnostic criteria of oral lichen planus and oral lichenoid lesion. A final diagnosis of oral lichen planus was made only after the correlation of the clinical diagnosis with the histopathological diagnosis. The interobserver agreement among three observers for both prospective and retrospective cases in the final diagnosis of oral lichen planus was found to be "good" to "very good" indicating high reproducibility. However, the final diagnoses of true oral lichen planus after clinico-pathological correlation in prospective and retrospective study groups appeared to be 38.0% and 54.0% respectively. The results of the present study revealed mild to moderate clinico-pathological correlation in the final diagnosis of oral lichen planus for the prospective and retrospective study groups respectively.

The fate of prospective spine studies registered on www.ClinicalTrials.gov.

PubMed

Ohnmeiss, Donna D

2015-03-01

There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by

Iranian Clinical Nurses’ Activities for Self-Directed Learning: A Qualitative Study

PubMed Central

Ghiyasvandian, Shahrzad; Malekian, Morteza; Cheraghi, Mohammad Ali

2016-01-01

Background: Clinical nurses need lifelong learning skills for responding to the rapid changes of clinical settings. One of the best strategies for lifelong learning is self-directed learning. The aim of this study was to explore Iranian clinical nurses’ activities for self-directed learning. Methods: In this qualitative study, 23 semi-structured personal interviews were conducted with nineteen clinical nurses working in all four hospitals affiliated to Isfahan Social Security Organization, Isfahan, Iran. Study data were analyzed by using the content analysis approach. The study was conducted from June 2013 to October 2014. Findings: Study participants’ activities for self-directed learning fell into two main categories of striving for knowledge acquisition and striving for skill development. The main theme of the study was ‘Revising personal performance based on intellectual-experiential activities’. Conclusions: Study findings suggest that Iranian clinical nurses continually revise their personal performance by performing self-directed intellectual and experiential activities to acquire expertise. The process of acquiring expertise is a linear process which includes two key steps of knowledge acquisition and knowledge development. In order to acquire and advance their knowledge, nurses perform mental learning activities such as sensory perception, self-evaluation, and suspended judgment step-by-step. Moreover, they develop their skills through doing activities like apprenticeship, masterly performance, and self-regulation. The absolute prerequisite to expertise acquisition is that a nurse needs to follow these two steps in a sequential manner. PMID:26652072

[A clinical and pathological study of coccidioidomycosis and pregnancy in four Mexican women].

PubMed

Calderón Garcidueñas, Ana Laura; Piña Osuna, Karina; Cerda Flores, Ricardo M

2004-09-01

In northeastern Mexican population prevalence of positive cutaneous reaction to coccidioidin varies from 30 to 49%. Pregnancy is a risk factor for disseminated coccidioidomycosis. 1) To describe the clinical spectrum of coccidioidomycosis in four women who acquired the disease during pregnancy or puerperium. 2) To discuss the autopsy findings. 3) To review the medical literature. From 1983 to 2000, files of the Pathology Department of a reference tertiary hospital in northeastern Mexico were reviewed. Four cases of 4,598 autopsies corresponded to pregnant women with coccidioidomycosis. Clinical and autopsy charts, and the histological material were studied. Clinical spectrum included a septicemia case with fetal lost, an atypical pneumonia, a chronic meningitis with neuropsychiatric alterations and a patient with hypertensive pregnancy disease with secondary renal insufficiency and repeated episodes of pneumonia. All patients at autopsy showed multiple granulomas with abundant mycotic spherules. Lung involvement included bilateral 2-10 mm nodules. In pregnant women of endemic areas or who had traveled to these zones during pregnancy, coccidioidomycosis should be considered in the differential diagnosis of febrile syndrome with pneumonia, specially if it is accompanied of bilateral nodular infiltrates in lung, with or without erythema nodosum or meningitis.

Conducting feasibilities in clinical trials: an investment to ensure a good study.

PubMed

Rajadhyaksha, Viraj

2010-07-01

Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

Effect of antiretroviral therapy on clinical and immunologic disease progression in HIV positive children: One-year follow-up study

PubMed Central

Patel, Ankur; Trivedi, Sangeeta S.; Chudasama, Rajesh K.; Patel, Priyanka K.

2012-01-01

Objective: To study the effect of antiretroviral therapy (ART) on clinical, immunologic, and nutritional progression of disease in human immunodeficiency virus (HIV)-infected children for 1 year. Materials and Methods: The study included 54 children aged 1.5–15 years who registered at the ART center, Surat, from August 2007 to August 2009. During the study period, the children were followed-up at 6 monthly intervals up to 1 year after starting ART. World Health Organization (WHO) clinical staging and CD4 cell count as per national guidelines, and nutritional status were used to measure clinical and immunologic progression of disease up to 1 year. Results: Out of 54 children, mother-to-child transmission was reported in 96.2% children; for 74% of the children, both parents were HIV positive. All the children were classified according to WHO clinical staging into 4 stages and as per CD4 cell count (%), followed up at 6 and 12 months and the benefits with ART reported. At 12 months follow-up, 15% of the study group children had died. Both mean CD4 count and a relative percentage showed significant increase (P < 0.01) in the study group 1 year after ART. Conclusion: The present study reports benefits of ART in terms of clinical and immunologic progression of disease, nutritional status of HIV-infected children after 1 year of ART. PMID:23230384

Criteria for selection and application of molecular markers for clinical studies of osteoarthritis.

PubMed

Otterness, I G; Swindell, A C

2003-03-01

To develop criteria for the selection and application of molecular markers for the study of osteoarthritis (OA). Statistical criteria for marker selection for OA are developed. After studying more than 20 different molecular markers for monitoring OA, procedures for choosing markers for clinical studies have been developed. For a particular study, the process starts with the markers showing 'face-validity' for monitoring OA. They are next required to successfully distinguish OA patients from controls. This necessitates definition of the distribution of marker values in OA patients and controls. So far, they have been consistently log-normal. The difference (Delta) in marker values between OA and controls defines the opportunity for marker improvement. The between-visit standard deviation (S) in patients puts limits on the detection of marker changes. The two variables can be combined to estimate the practicality of a marker using a modified power analysis. The number of patients (N*) required to observe a 50% improvement with an alpha level of P=0.05 and with 80% certainty is estimated as 50(S/Delta)(2). N*, S and Delta should be used to characterize and compare markers. Marker efficiency can be refined by regressing on secondary variables, such as age, sex, BMI, severity, etc. Finally, the use of two or more markers may be required to improve marker prediction of clinical outcome. Correlated markers can be used to reinforce conclusions by essentially adding replicative data. Independent, complementary markers can be used to develop associations with clinical parameters, and perhaps diagnose and monitor disease status, activities that so far have not been possible with single markers.

Clinical characteristics of an Afrikaner founder population recruited for a schizophrenia genetic study.

PubMed

Roos, Johannes Lodewikus; Pretorius, Herman Walter; Karayiorgou, Maria

2009-01-01

The clinical characteristics of an Afrikaner founder population sample recruited for a schizophrenia genetic study are described. Comparisons on several clinical characteristics between this sample and a U.S. sample of schizophrenia patients show that generalization of findings in a founder population to the population at large is applicable. The assessment of the frequency of the 22q11 deletion in Afrikaner schizophrenia patients is approximately 2%, similar to findings in a U.S. sample. Results of analysis of early non-psychotic deviant behavior in subjects under the age of 10 years in the Afrikaner population broadly replicated findings in a U.S. sample. Approximately half of male schizophrenia patients and a quarter of female patients in the Afrikaner schizophrenia database used or abused cannabis. Male users of cannabis with severe early deviant behavior had the lowest mean age of criteria onset, namely 18.4 years. These findings confirm previous findings, indicating that early deviance is linked to later outcome of disease. The clinical characteristics and premorbid variables in 12 childhood-onset Afrikaner schizophrenia patients thus far recruited in this study compare favorably with what is known about childhood-onset schizophrenia in a U.S. sample. The prevalence of co-morbid OCD/OCS in this Afrikaner schizophrenia founder sample was 13.2% which is in keeping with that of co-morbid OCD in schizophrenia, estimated at 12.2% by the U.S. National Institute of Mental Health. These findings confirm that the clinical characteristics of a schizophrenia sample drawn from the Afrikaner founder population can be generalized to the schizophrenia population at large when compared to findings reported in the literature.

Mental Subnormality in the Community: A Clinical and Epidemiologic Study.

ERIC Educational Resources Information Center

Birch, Herbert G.; And Others

The book reports a clinical and epidemiologic study of the prevalence, distribution, and antecedents of mental subnormality in 8 to 10 year old children living in Aberdeen, Scotland (population 187,000). Utilizing three types of data (differential clinical diagnoses, biological background information, and social characteristics), the study…

International Pediatric MS Study Group Clinical Trials Summit: meeting report.

PubMed

Chitnis, Tanuja; Tardieu, Marc; Amato, Maria Pia; Banwell, Brenda; Bar-Or, Amit; Ghezzi, Angelo; Kornberg, Andrew; Krupp, Lauren B; Pohl, Daniela; Rostasy, Kevin; Tenembaum, Silvia; Waubant, Emmanuelle; Wassmer, Evangeline

2013-03-19

Pediatric studies for new biological agents are mandated by recent legislation, necessitating careful thought to evaluation of emerging multiple sclerosis (MS) therapies in children with MS. Challenges include a small patient population, the lack of prior randomized clinical trials, and ethical concerns. The goal of this meeting was to assess areas of consensus regarding clinical trial design and outcome measures among academic experts involved in pediatric MS care and research. The Steering Committee of the International Pediatric MS Study Group identified key focus areas for discussion. A total of 69 meeting attendees were assembled, including 35 academic experts. Regulatory and pharmaceutical representatives also attended, and provided input, which informed academic expert consensus decisions. The academic experts agreed that clinical trials were necessary in pediatric MS to obtain pharmacokinetic, safety and efficacy data, and regulatory approval allowing for greater medication access. The academic experts agreed that relapse was an appropriate primary outcome measure for phase III pediatric trials. An international standardized cognitive battery was identified. The pros and cons of various trial designs were discussed. Guidelines surrounding MRI studies, pharmacokinetics, pharmacodynamics, and registries were developed. The academic experts agreed that given the limited subject pool, a stepwise approach to the launch of clinical trials for the most promising medications is necessary in order to ensure study completion. Alternative approaches could result in unethical exposure of patients to trial conditions without gaining knowledge. Consensus points for conduct of clinical trials in the rare disease pediatric MS were identified amongst a panel of academic experts, informed by regulatory and industry stakeholders.

Results of an Oncology Clinical Trial Nurse Role Delineation Study.

PubMed

Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

2017-09-01

To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

PubMed

Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

Clinical analysis of 48 cases of inverse psoriasis: a hospital-based study.

PubMed

Wang, Gang; Li, Chunying; Gao, Tianwen; Liu, Yufeng

2005-01-01

Inverse psoriasis, rare in clinical practice, refers to psoriasis only or mainly occurring at flexural sites, such as the axilla, antecubital fossae, popliteal fossae, and inguinal creases. It is also known as flexural psoriasis. With a total collection of psoriatic cases from September 2002 to December 2003 at Xijing hospital, we made a retrospective analysis of the disease history, clinical characteristics, and treatment of the patients affected with inverse psoriasis. The results showed that the major clinical manifestations of inverse psoriasis were sharply demarcated erythematous plaques with varying degrees of infiltration and minimal or no scales. Affected areas often involve the groin, axilla, genitals, and umbilicus. The disease responds well to the narrow band UVB therapy. Compared with common psoriasis, inverse psoriasis has similar and unique characteristics in terms of the affected areas, clinical symptoms, and responses to the treatment.

2015 Guidance on cancer immunotherapy development in early-phase clinical studies.

PubMed

2015-12-01

The development of cancer immunotherapies is progressing rapidly with a variety of technological approaches. They consist of "cancer vaccines", which are based on the idea of vaccination, "effector cell therapy", classified as passive immunotherapy, and "inhibition of immunosuppression", which intends to break immunological tolerance to autoantigens or immunosuppressive environments characterizing antitumor immune responses. Recent reports showing clinical evidence of efficacy of immune checkpoint inhibitors and adoptive immunotherapies with tumor-infiltrating lymphocytes and tumor-specific receptor gene-modified T cells indicate the beginning of a new era for cancer immunotherapy. This guidance summarizes ideas that will be helpful to those who plan to develop cancer immunotherapy. The aims of this guidance are to discuss and offer important points in early phase clinical studies of innovative cancer immunotherapy, with future progress in this field, and to contribute to the effective development of cancer immunotherapy aligned with the scope of regulatory science. This guidance covers cancer vaccines, effector cell therapy, and inhibition of immunosuppression, including immune checkpoint inhibitors. © 2015 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.

Periodontal Status in Smokers and Nonsmokers: A Clinical, Microbiological, and Histopathological Study

PubMed Central

Sreedevi, Maddipati; Ramesh, Alampalli; Dwarakanath, Chini

2012-01-01

A case-control study was done to assess the influence of smoking on clinical, microbiological, and histopathological parameters. Methods. Two hundred dentate male patients (100 smokers and 100 nonsmokers) ranging between 25 and 50 years were enrolled in the study. Periodontal parameters were recorded. Plaque samples were collected for microbial analysis for BANA test. Gingival biopsies were obtained from selected site for assessing histopathological changes. Results. Both groups showed almost similar plaque levels (P=0.258), but smokers had reduced gingival (0.62 ± 0.31) and bleeding indices (28.53 ± 17.52) and an increased calculus index (1.62 ± 0.36). Smokers had an increased probing depth of 4–7 mm (P=0.009) and overall increased CAL. No difference in microbiota was found between the two groups. Histopathologically smokers showed a decreased blood vessel density (8.84 ± 0.96) and inflammatory cells (52.00 ± 9.79). Conclusions. It is quite possible that many of the pathogenic mechanisms involved in tissue degradation in periodontitis in smokers could be quite different from those in nonsmokers. PMID:22505904

Clinical study of children with cryofibrinogenemia: a retrospective study from a single center.

PubMed

Chou, Hsiao-Feng; Wu, Yu-Hung; Ho, Che-Sheng; Kao, Yu-Hsuan

2018-04-24

This study aimed to evaluate the demographic, clinical features, laboratory data, pathology and other survey in pediatric patients with cryofibrinogenemia. A 12-year retrospective chart review identified eight pediatric patients at Mackay Memorial Hospital, Taipei, Taiwan. The female-to-male ratio was 3:1. The mean age at symptom onset and of diagnosis was 10.3 ± 4.6 years and 12.3 ± 4 years, respectively. One child (12.5%) had primary cryofibrinogenemia. The common symptoms were purpura, arthralgia, and muscle weakness (100%). On laboratory examination, cryofibrinogen was positive in all patients. All patients had increased anti-thrombin III while 87.5% and 62.5% had abnormal protein S and protein C, respectively. All eight also complained of neurologic symptoms. One had vertebral artery narrowing, two showed increased T2-weighted signal intensity on the thalamus or white matter, and one had acute hemorrhagic encephalomyelitis on brain magnetic resonance imaging. This study reports on the presentations of cryofibrinogenemia, which is rare in children. Most cases are associated with autoimmune disease and have severe and complex presentations. Central nervous system involvement is common.

Clinical handover practices in maternity services in Ireland: A qualitative descriptive study.

PubMed

Fealy, Gerard; Munroe, Deirdre; Riordan, Fiona; Croke, Eilish; Conroy, Celine; McNamara, Martin; Shannon, Michael

2016-08-01

the objective was to examine and describe clinical handover practices in Irish maternity services. the study design incorporated interviews and focus group discussions with a purposive sample of healthcare practitioners working in Irish maternity services. five maternity hospitals and fourteen co-located maternity units. midwives, obstetricians and other healthcare professionals, specifically physiotherapists and radiologists, midwifery students and health care assistants working in maternity services. the study participants provided nuanced and differentiated accounts of clinical handover practices, which indicated a general absence of formal policy and training on clinical handover and the practice of midwifery and medical teams holding separate clinical handovers based on their separate, respective needs for transferring information and clinical responsibility. Participants spoke of barriers to effective clinical handover, including unsuitable environments, lack of dedicated time and fatigue during duty shift clinical handover, lack of supportive information technology (IT) infrastructure, and resistance of some staff to the adoption of new technologies to support clinical handover. whether internal and external to clinical handover events, the barriers to effective clinical handover represent threats to patient safety and quality of care, since effective clinical handover is essential to the provision of safe quality care. clear and effective communication between collaborating professionals within maternity teams is essential. Copyright © 2016 Elsevier Ltd. All rights reserved.