Increased T2 signal intensity in the distal clavicle: incidence and clinical implications

International Nuclear Information System (INIS)

Fiorella, D.; Helms, C.A.; Speer, K.P.

2000-01-01

Objective. The objectives of the current study were (1) to quantify the incidence of increased T2 signal in the distal clavicle and (2) to assess the clinical significance of this finding in patients with chronic acromioclavicular (AC) joint pain.Design and patients. Eight patients (five male and three female, 15-41 years of age) with disabling shoulder pain localized to the AC joint and marked increased T2 signal in the distal clavicle are presented. These eight patients underwent MR examination over a 25 month period (August 1996 to September 1998). The dictated reports of all shoulder MR examinations conducted over this same time period were reviewed retrospectively for the presence of signal abnormality in the distal cla-vicle. Clinical data and, in five patients, findings at shoulder arthroscopy or open surgery, were correlated with the results of MR imaging. One patient underwent arthroscopy on both shoulders.Results. The selected eight patients each presented clinically with disabling shoulder pain localized to the AC joint. One patient is presented twice, as both shoulders were symptomatic (n=9). Plain film examination (9/9) failed to indicate a structural cause of shoulder pain in any of the patients. MR examination demonstrated abnormally increased T2 signal in the distal clavicle in all nine cases and no other cause for AC joint pain. Three patients responded to a course of conservative therapy. Six experienced refractory pain despite conservative therapy. Resection of the distal clavicle was performed in five of the six cases. All patients who underwent resection of the distal clavicle experienced complete resolution of AC joint pain. A retrospective review of the dictated reports for all shoulder MR imaging examinations performed at out institution over a 25 month period (August 1996 to September 1998; n=761) demonstrated a 12.5% incidence of abnormally increased T2 signal in the distal clav-icle.Conclusions. Increased T2 signal in the distal clavicle

Increased T2 signal intensity in the distal clavicle: incidence and clinical implications

Energy Technology Data Exchange (ETDEWEB)

Fiorella, D.; Helms, C.A. [Dept. of Radiology, Duke Univ., Durham, NC (United States); Speer, K.P. [Dept. of Orthopedic Surgery, Duke Univ., Durham, NC (United States)

2000-12-01

Objective. The objectives of the current study were (1) to quantify the incidence of increased T2 signal in the distal clavicle and (2) to assess the clinical significance of this finding in patients with chronic acromioclavicular (AC) joint pain.Design and patients. Eight patients (five male and three female, 15-41 years of age) with disabling shoulder pain localized to the AC joint and marked increased T2 signal in the distal clavicle are presented. These eight patients underwent MR examination over a 25 month period (August 1996 to September 1998). The dictated reports of all shoulder MR examinations conducted over this same time period were reviewed retrospectively for the presence of signal abnormality in the distal cla-vicle. Clinical data and, in five patients, findings at shoulder arthroscopy or open surgery, were correlated with the results of MR imaging. One patient underwent arthroscopy on both shoulders.Results. The selected eight patients each presented clinically with disabling shoulder pain localized to the AC joint. One patient is presented twice, as both shoulders were symptomatic (n=9). Plain film examination (9/9) failed to indicate a structural cause of shoulder pain in any of the patients. MR examination demonstrated abnormally increased T2 signal in the distal clavicle in all nine cases and no other cause for AC joint pain. Three patients responded to a course of conservative therapy. Six experienced refractory pain despite conservative therapy. Resection of the distal clavicle was performed in five of the six cases. All patients who underwent resection of the distal clavicle experienced complete resolution of AC joint pain. A retrospective review of the dictated reports for all shoulder MR imaging examinations performed at out institution over a 25 month period (August 1996 to September 1998; n=761) demonstrated a 12.5% incidence of abnormally increased T2 signal in the distal clav-icle.Conclusions. Increased T2 signal in the distal clavicle

Using Local Grammar for Entity Extraction from Clinical Reports

Directory of Open Access Journals (Sweden)

Aicha Ghoulam

2015-06-01

Full Text Available Information Extraction (IE is a natural language processing (NLP task whose aim is to analyze texts written in natural language to extract structured and useful information such as named entities and semantic relations linking these entities. Information extraction is an important task for many applications such as bio-medical literature mining, customer care, community websites, and personal information management. The increasing information available in patient clinical reports is difficult to access. As it is often in an unstructured text form, doctors need tools to enable them access to this information and the ability to search it. Hence, a system for extracting this information in a structured form can benefits healthcare professionals. The work presented in this paper uses a local grammar approach to extract medical named entities from French patient clinical reports. Experimental results show that the proposed approach achieved an F-Measure of 90. 06%.

[Writing and publication of a clinical case report].

Science.gov (United States)

Târcoveanu, E; Roca, M; Mihăescu, T

2011-01-01

A case report represents a collection of detailed information about an individual patient, written with the purpose to disseminate clinical outcomes, not previously reported. Case reports provide a rich resource for teaching and research in medicine. Despite the limitation of case reports, these are useful to generate new hypothesis for future large scale clinical trials. A clinical case report should be well structured and convey a clear message. Elements of a case report are similar to all forms of medical scientific articles: title, structured abstract, introduction, case report, discussion, conclusion and references. A well written case report with literature support and a detailed description of management of the case has the greatest chances to be published. "Uniform Requirements for Manuscripts to Biomedical Journals" form the basis for most journal instructions regarding content and formatting and should be consulted when journal's instructions don't answer to author's questions. In this paper we present a case report check sheet to use as a form of self-evaluation, prior to submitting the articles.

Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

DEFF Research Database (Denmark)

Lifson, A; Rhame, F; Bellosa, W

2006-01-01

adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...

Workplace-based clinical leadership training increases willingness to lead.

Science.gov (United States)

MacPhail, Aleece; Young, Carmel; Ibrahim, Joseph Elias

2015-01-01

The purpose of this paper is to reflect upon a workplace-based, interdisciplinary clinical leadership training programme (CLP) to increase willingness to take on leadership roles in a large regional health-care centre in Victoria, Australia. Strengthening the leadership capacity of clinical staff is an advocated strategy for improving patient safety and quality of care. An interdisciplinary approach to leadership is increasingly emphasised in the literature; however, externally sourced training programmes are expensive and tend to target a single discipline. Appraisal of the first two years of CLP using multiple sourced feedback. A structured survey questionnaire with closed-ended questions graded using a five-point Likert scale was completed by participants of the 2012 programme. Participants from the 2011 programme were followed up for 18 months after completion of the programme to identify the uptake of new leadership roles. A reflective session was also completed by a senior executive staff that supported the implementation of the programme. Workplace-based CLP is a low-cost and multidisciplinary alternative to externally sourced leadership courses. The CLP significantly increased willingness to take on leadership roles. Most participants (93 per cent) reported that they were more willing to take on a leadership role within their team. Fewer were willing to lead at the level of department (79 per cent) or organisation (64 per cent). Five of the 11 participants from the 2011 programme had taken on a new leadership role 18 months later. Senior executive feedback was positive especially around the engagement and building of staff confidence. They considered that the CLP had sufficient merit to support continuation for at least another two years. Integrating health-care professionals into formal and informal leadership roles is essential to implement organisational change as part of the drive to improve the safety and quality of care for patients and service users

Clinical report writing: Process and perspective

Science.gov (United States)

Ewald, H. R.

1981-01-01

Clinical report writing in psychology and psychiatry is addressed. Audience/use analysis and the basic procedures of information gathering, diagnosis, and prognosis are described. Two interlinking processes are involved: the process of creation and the process of communication. Techniques for good report writing are presented.

Prevalence of estimated GFR reporting among US clinical laboratories.

Science.gov (United States)

Accetta, Nancy A; Gladstone, Elisa H; DiSogra, Charles; Wright, Elizabeth C; Briggs, Michael; Narva, Andrew S

2008-10-01

Routine laboratory reporting of estimated glomerular filtration rate (eGFR) may help clinicians detect kidney disease. The current national prevalence of eGFR reporting in clinical laboratories is unknown; thus, the extent of the situation of laboratories not routinely reporting eGFR with serum creatinine results is not quantified. Observational analysis. National Kidney Disease Education Program survey of clinical laboratories conducted in 2006 to 2007 by mail, web, and telephone follow-up. A national random sample, 6,350 clinical laboratories, drawn from the Federal Clinical Laboratory Improvement Amendments database and stratified by 6 major laboratory types/groupings. Laboratory reports serum creatinine results. Reporting eGFR values with serum creatinine results. Percentage of laboratories reporting eGFR along with reporting serum creatinine values, reporting protocol, eGFR formula used, and style of reporting cutoff values. Of laboratories reporting serum creatinine values, 38.4% report eGFR (physician offices, 25.8%; hospitals, 43.6%; independents, 38.9%; community clinics, 47.2%; health fair/insurance/public health, 45.5%; and others, 43.2%). Physician office laboratories have a reporting prevalence lower than other laboratory types (P laboratories reporting eGFR, 66.7% do so routinely with all adult serum creatinine determinations; 71.6% use the 4-variable Modification of Diet in Renal Disease Study equation; and 45.3% use the ">60 mL/min/1.73 m(2)" reporting convention. Independent laboratories are least likely to routinely report eGFR (50.6%; P laboratories across all strata are more likely to report eGFR (P laboratories, federal database did not have names of laboratory directors/managers (intended respondents), assumed accuracy of federal database for sample purposes. Routine eGFR reporting with serum creatinine values is not yet universal, and laboratories vary in their reporting practices.

Report of China's innovation increase and research growth in radiation oncology.

Science.gov (United States)

Zhu, Hongcheng; Yang, Xi; Qin, Qin; Bian, Kangqi; Zhang, Chi; Liu, Jia; Cheng, Hongyan; Sun, Xinchen

2014-06-01

To investigate the research status of radiation oncology in China through survey of literature in international radiation oncology journals and retrospectively compare the outputs of radiation oncology articles of the three major regions of China-Mainland (ML), Taiwan (TW) and Hong Kong (HK). Radiation oncology journals were selected from "oncology" and "radiology, nuclear & medical image" category from Science Citation Index Expand (SCIE). Articles from the ML, TW and HK were retrieved from MEDLINE. The number of total articles, clinical trials, case reports, impact factors (IF), institutions and articles published in each journals were conducted for quantity and quality comparisons. A total 818 articles from 13 radiation oncology journals were searched, of which 427 are from ML, 259 from TW, and 132 from HK. Ninety-seven clinical trials and 5 case reports are reported in China. Accumulated IF of articles from ML (1,417.11) was much higher than that of TW (1,003.093) and HK (544.711), while the average IF of articles from ML is the lowest. The total number of articles from China especially ML increased significantly in the last decade. The number of articles published from the ML has exceeded those from TW and HK. However, the quality of articles from TW and HK is better than that from ML.

Unsupervised grammar induction of clinical report sublanguage

Directory of Open Access Journals (Sweden)

Kate Rohit J

2012-10-01

Full Text Available Abstract Background Clinical reports are written using a subset of natural language while employing many domain-specific terms; such a language is also known as a sublanguage for a scientific or a technical domain. Different genres of clinical reports use different sublaguages, and in addition, different medical facilities use different medical language conventions. This makes supervised training of a parser for clinical sentences very difficult as it would require expensive annotation effort to adapt to every type of clinical text. Methods In this paper, we present an unsupervised method which automatically induces a grammar and a parser for the sublanguage of a given genre of clinical reports from a corpus with no annotations. In order to capture sentence structures specific to clinical domains, the grammar is induced in terms of semantic classes of clinical terms in addition to part-of-speech tags. Our method induces grammar by minimizing the combined encoding cost of the grammar and the corresponding sentence derivations. The probabilities for the productions of the induced grammar are then learned from the unannotated corpus using an instance of the expectation-maximization algorithm. Results Our experiments show that the induced grammar is able to parse novel sentences. Using a dataset of discharge summary sentences with no annotations, our method obtains 60.5% F-measure for parse-bracketing on sentences of maximum length 10. By varying a parameter, the method can induce a range of grammars, from very specific to very general, and obtains the best performance in between the two extremes.

Unsupervised grammar induction of clinical report sublanguage.

Science.gov (United States)

Kate, Rohit J

2012-10-05

Clinical reports are written using a subset of natural language while employing many domain-specific terms; such a language is also known as a sublanguage for a scientific or a technical domain. Different genres of clinical reports use different sublaguages, and in addition, different medical facilities use different medical language conventions. This makes supervised training of a parser for clinical sentences very difficult as it would require expensive annotation effort to adapt to every type of clinical text. In this paper, we present an unsupervised method which automatically induces a grammar and a parser for the sublanguage of a given genre of clinical reports from a corpus with no annotations. In order to capture sentence structures specific to clinical domains, the grammar is induced in terms of semantic classes of clinical terms in addition to part-of-speech tags. Our method induces grammar by minimizing the combined encoding cost of the grammar and the corresponding sentence derivations. The probabilities for the productions of the induced grammar are then learned from the unannotated corpus using an instance of the expectation-maximization algorithm. Our experiments show that the induced grammar is able to parse novel sentences. Using a dataset of discharge summary sentences with no annotations, our method obtains 60.5% F-measure for parse-bracketing on sentences of maximum length 10. By varying a parameter, the method can induce a range of grammars, from very specific to very general, and obtains the best performance in between the two extremes.

Consistency between Self-Reported and Recorded Values for Clinical Measures

OpenAIRE

III, Joseph Thomas; Paulet, Mindy; Rajpura, Jigar R.

2016-01-01

Objectives. This study evaluated consistency between self-reported values for clinical measures and recorded clinical measures. Methods. Self-reported values were collected for the clinical measures: systolic blood pressure, diastolic blood pressure, glucose level, height, weight, and cholesterol from health risk assessments completed by enrollees in a privately insured cohort. Body mass index (BMI) was computed from reported height and weight. Practitioner recorded values for the clinical me...

Citation of prior research has increased in introduction and discussion sections with time: A survey of clinical trials in physiotherapy.

Science.gov (United States)

Hoderlein, Xenia; Moseley, Anne M; Elkins, Mark R

2017-08-01

Many clinical trials are reported without reference to the existing relevant high-quality research. This study aimed to investigate the extent to which authors of reports of clinical trials of physiotherapy interventions try to use high-quality clinical research to (1) help justify the need for the trial in the introduction and (2) help interpret the trial's results in the discussion. Data were extracted from 221 clinical trials that were randomly selected from the Physiotherapy Evidence Database: 70 published in 2001 (10% sample) and 151 published in 2015 (10% sample). The Physiotherapy Evidence Database score (which rates methodological quality and completeness of reporting) for each trial was also downloaded. Overall 41% of trial reports cited a systematic review or the results of a search for other evidence in the introduction section: 20% for 2001 and 50% for 2015 (relative risk = 2.3, 95% confidence interval = 1.5-3.8). For the discussion section, only 1 of 221 trials integrated the results of the trial into an existing meta-analysis, but citation of a relevant systematic review did increase from 17% in 2001 to 34% in 2015. There was no relationship between citation of existing research and the total Physiotherapy Evidence Database score. Published reports of clinical trials of physiotherapy interventions increasingly cite a systematic review or the results of a search for other evidence in the introduction, but integration with existing research in the discussion section is very rare. To encourage the use of existing research, stronger recommendations to refer to existing systematic reviews (where available) could be incorporated into reporting checklists and journal editorial guidelines.

Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review.

Science.gov (United States)

de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J

2018-05-01

Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to

SeqReporter: automating next-generation sequencing result interpretation and reporting workflow in a clinical laboratory.

Science.gov (United States)

Roy, Somak; Durso, Mary Beth; Wald, Abigail; Nikiforov, Yuri E; Nikiforova, Marina N

2014-01-01

A wide repertoire of bioinformatics applications exist for next-generation sequencing data analysis; however, certain requirements of the clinical molecular laboratory limit their use: i) comprehensive report generation, ii) compatibility with existing laboratory information systems and computer operating system, iii) knowledgebase development, iv) quality management, and v) data security. SeqReporter is a web-based application developed using ASP.NET framework version 4.0. The client-side was designed using HTML5, CSS3, and Javascript. The server-side processing (VB.NET) relied on interaction with a customized SQL server 2008 R2 database. Overall, 104 cases (1062 variant calls) were analyzed by SeqReporter. Each variant call was classified into one of five report levels: i) known clinical significance, ii) uncertain clinical significance, iii) pending pathologists' review, iv) synonymous and deep intronic, and v) platform and panel-specific sequence errors. SeqReporter correctly annotated and classified 99.9% (859 of 860) of sequence variants, including 68.7% synonymous single-nucleotide variants, 28.3% nonsynonymous single-nucleotide variants, 1.7% insertions, and 1.3% deletions. One variant of potential clinical significance was re-classified after pathologist review. Laboratory information system-compatible clinical reports were generated automatically. SeqReporter also facilitated quality management activities. SeqReporter is an example of a customized and well-designed informatics solution to optimize and automate the downstream analysis of clinical next-generation sequencing data. We propose it as a model that may envisage the development of a comprehensive clinical informatics solution. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

Science.gov (United States)

Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

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

Science.gov (United States)

Mohammadzadeh, Niloofar; Safdari, Reza

2014-01-01

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

Best clinical trials reported in 2010.

Science.gov (United States)

Garner, John B; Grayburn, Paul A; Yancy, Clyde W

2011-07-01

Each year, a number of clinical trials emerge with data sufficient to change clinical practice. Determining which findings will result in practice change and which will provide only incremental benefit can be a dilemma for clinicians. The authors review selected clinical trials reported in 2010 in journals, at society meetings, and at conferences, focusing on those studies that have the potential to change clinical practice. This review offers 3 separate means of analysis: an abbreviated text summary, organized by subject area; a comprehensive table of relevant clinical trials that provides a schematic review of the hypotheses, interventions, methods, primary end points, results, and implications; and a complete bibliography for further reading as warranted. It is hoped that this compilation of relevant clinical trials and their important findings released in 2010 will be of benefit in the everyday practice of cardiovascular medicine. Copyright © 2011 Elsevier Inc. All rights reserved.

NASPGHAN Capsule Endoscopy Clinical Report.

Science.gov (United States)

Friedlander, Joel A; Liu, Quin Y; Sahn, Benjamin; Kooros, Koorosh; Walsh, Catharine M; Kramer, Robert E; Lightdale, Jenifer R; Khlevner, Julie; McOmber, Mark; Kurowski, Jacob; Giefer, Matthew J; Pall, Harpreet; Troendle, David M; Utterson, Elizabeth C; Brill, Herbert; Zacur, George M; Lirio, Richard A; Lerner, Diana G; Reynolds, Carrie; Gibbons, Troy E; Wilsey, Michael; Liacouras, Chris A; Fishman, Douglas S

2017-03-01

Wireless capsule endoscopy (CE) was introduced in 2000 as a less invasive method to visualize the distal small bowel in adults. Because this technology has advanced it has been adapted for use in pediatric gastroenterology. Several studies have described its clinical use, utility, and various training methods but pediatric literature regarding CE is limited. This clinical report developed by the Endoscopic and Procedures Committee of the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition outlines the current literature, and describes the recommended current role, use, training, and future areas of research for CE in pediatrics.

Increasing clinical relevance in oral radiology: Benefits and challenges when implementing digital assessment.

Science.gov (United States)

de Lange, T; Møystad, A; Torgersen, G R

2018-02-13

The aims of the study were to investigate benefits and challenges in implementing a digital examination and study the clinical relevance of the digital examination in relation to clinical training and practice. The study was based on semi-structured focus-group interviews from two distinct student populations (2016 and 2017) in a bachelor programme in dental hygiene. In addition, conversational data from a plenary discussion from the whole second student population (2017) were collected and analysed. The data were approached on basis of content analysis. A benefit experienced in the digital examination was the ease in typing and editing answers on the computer. This suggests an increased effectiveness in computer-based compared to analogue examinations. An additional advantage was the experienced relevance of the examination related to the clinic. This finding refers not only to the digital presentations of images, but also to the entire setting in the clinic and dental practice. The limitations reported by the students were non-optimal viewing conditions for presenting radiographic images and difficulties in obtaining an overview of the assignments compared to paper-based examinations due to the linear digital examination format. The last finding on lacking overview revealed an influence on student performances which should be taken seriously in designing digital examinations. In conclusion, the digital layout increases efficiency and clinical relevance of examinations to a certain extent. Obstacles were found in limitations related to image presentation and lack of overview of the examination. The latter challenge raises questions related to developing suitable assessment software. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Increasing diabetic patient engagement and self-reported medication adherence using a web-based multimedia program.

Science.gov (United States)

Elsabrout, Kerri

2018-05-01

Evidence-based, multimedia applications to supplement clinical care can improve patient engagement and clinical outcomes. Patients with diabetes with potentially devastating complication of foot ulcers present a substantial opportunity to improve engagement. This project examines how providing an online, multimedia self-management program affects patient engagement and self-reported medication adherence scores within 4-6 weeks compared with preprogram scores. Participants included 14 adult, diabetic outpatients receiving care at a Wound Care Center in suburban New York. Participants watched a Type 2 diabetes Emmi educational module on an electronic tablet during a routine wound treatment visit. Self-reported medication adherence was measured immediately before and at 4-6 weeks after the educational intervention. Patient engagement was measured immediately before, immediately after, and at 4-6 weeks postintervention. Self-reported medication adherence results demonstrated a modest increase at the delayed postintervention time. In addition, there was a large increase in engagement scores at the delayed postintervention time. The direction of change for both measures was consistent with the intervention being effective. Incorporating this type of novel, multimedia patient education resource may provide opportunities to enhance diabetes care.

Analysis of the Radiology Reports from Radiology Clinics

International Nuclear Information System (INIS)

Kim, Eun Jin; Kwack, Kyu Sung; Cho, Jae Hyun; Jang, Eun Ho

2009-01-01

The purpose of this study was to investigate the form and content of the radiology reports from radiology clinics in Korea. One hundred and sixty six radiology reports from 49 radiology clinics were collected, and these reports were referred to the academic tertiary medical center from March 2008 to February 2009. These included reports for CT (n = 18), MRI (n = 146) and examinations not specified (n = 2). Each report was evaluated for the presence of required contents (demographics, technical information, findings, conclusion, the name, license number and signature of the radiologist and the referring facility). These requirements were based on the guideline of the American College of Radiology and the previous research. The name of the patient, the gender, the body part, the type of examination, the time of examination and the conclusion, the name of the radiologist and the name of facility were well recorded in over 90% of the radiology reports. However, the identification number of the patient, the referring facility, the referring physician, the use of contrast material, the clinical information, the time of dictation, the signature of the radiologist and the license number of the radiologist were poorly recorded (less than 50%). The optimal format of a radiology report should be established for reliable and valid communication with clinicians

Clinical events in coronary patients who report low distress: adverse effect of repressive coping.

Science.gov (United States)

Denollet, Johan; Martens, Elisabeth J; Nyklícek, Ivan; Conraads, Viviane M; de Gelder, Beatrice

2008-05-01

Coronary artery disease (CAD) patients who report low distress are considered to be at low psychological risk for clinical events. However, patients with a repressive coping style may fail to detect and report signals of emotional distress. The authors hypothesized that repressive CAD patients are at risk for clinical events, despite low self-rated distress. This was a prospective 5- to 10-year follow-up study, with a mean follow-up of 6.6 years. At baseline, 731 CAD patients filled out Trait-Anxiety (distress), Marlowe-Crowne (defensiveness), and Type D scales; 159 patients were classified as "repressive," 360 as "nonrepressive," and 212 as "Type D." The primary endpoint was a composite of total mortality or myocardial infarction (MI); the secondary endpoint was cardiac mortality/MI. No patients were lost to follow-up; 91 patients had a clinical event (including 35 cardiac death and 32 MI). Repressive patients reported low levels of anxiety, anger and depression at baseline, but were at increased risk for death/MI (21/159 = 13%) compared with nonrepressive patients (22/360 = 6%), p = .009. Poor systolic function, poor exercise tolerance, 3-vessel disease, index MI and Type-D personality--but not depression, anxiety or anger--also independently predicted clinical events. After controlling for these variables, repressive patients still had a twofold increased risk of death/MI, OR = 2.17, 95% CI = 1.10-4.08, p = .025). These findings were replicated for cardiac mortality/MI. CAD patients who use a repressive coping style are at increased risk for clinical events, despite their claims of low emotional distress. This phenomenon may cause an underestimation of the effect of stress on the heart. (PsycINFO Database Record (c) 2008 APA, all rights reserved).

Genetic risk of major depressive disorder: the moderating and mediating effects of neuroticism and psychological resilience on clinical and self-reported depression.

Science.gov (United States)

Navrady, L B; Adams, M J; Chan, S W Y; Ritchie, S J; McIntosh, A M

2017-11-29

Polygenic risk scores (PRS) for depression correlate with depression status and chronicity, and provide causal anchors to identify depressive mechanisms. Neuroticism is phenotypically and genetically positively associated with depression, whereas psychological resilience demonstrates negative phenotypic associations. Whether increased neuroticism and reduced resilience are downstream mediators of genetic risk for depression, and whether they contribute independently to risk remains unknown. Moderating and mediating relationships between depression PRS, neuroticism, resilience and both clinical and self-reported depression were examined in a large, population-based cohort, Generation Scotland: Scottish Family Health Study (N = 4166), using linear regression and structural equation modelling. Neuroticism and resilience were measured by the Eysenck Personality Scale Short Form Revised and the Brief Resilience Scale, respectively. PRS for depression was associated with increased likelihood of self-reported and clinical depression. No interaction was found between PRS and neuroticism, or between PRS and resilience. Neuroticism was associated with increased likelihood of self-reported and clinical depression, whereas resilience was associated with reduced risk. Structural equation modelling suggested the association between PRS and self-reported and clinical depression was mediated by neuroticism (43-57%), while resilience mediated the association in the opposite direction (37-40%). For both self-reported and clinical diagnoses, the genetic risk for depression was independently mediated by neuroticism and resilience. Findings suggest polygenic risk for depression increases vulnerability for self-reported and clinical depression through independent effects on increased neuroticism and reduced psychological resilience. In addition, two partially independent mechanisms - neuroticism and resilience - may form part of the pathway of vulnerability to depression.

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

Science.gov (United States)

Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

2016-12-15

Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

Childhood bruxism: a clinical review and case report.

Science.gov (United States)

Gupta, B; Marya, C M; Anegundi, R

2010-01-01

The present case report refers to a patient who reported to the department with the complaint of teeth grinding (Bruxism). A brief review of the literature is reported concerning the aetiology, clinical diagnosis and the therapeutic approach of the disease.

The CARE guidelines: consensus-based clinical case report guideline development.

Science.gov (United States)

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2014-01-01

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.

Sexual revictimization in a clinical sample of women reporting childhood sexual abuse

DEFF Research Database (Denmark)

Lau, Marianne; Kristensen, Ellids

2010-01-01

BACKGROUND: Child and adolescent sexual abuse (CSA) increases the risk for adult sexual assault (ASA), and psychological vulnerability as well as aspects of CSA and upbringing might influence the risk. AIMS: The aims of this study were to investigate whether women who reported both CSA and ASA: 1......: The results showed an increased psychological vulnerability among women with ASA, but whether the results are cause or effect of sexual revictimization or can be generalized to other clinical samples are not clear. Interventions targeting the increased risk of ASA should be developed, implemented and tested...

Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

Science.gov (United States)

Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

2018-05-09

We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other

Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network

Directory of Open Access Journals (Sweden)

Schulz Kenneth F

2010-04-01

Full Text Available Abstract Although current electronic methods of scientific publishing offer increased opportunities for publishing all research studies and describing them in sufficient detail, health research literature still suffers from many shortcomings. These shortcomings seriously undermine the value and utility of the literature and waste scarce resources invested in the research. In recent years there have been several positive steps aimed at improving this situation, such as a strengthening of journals' policies on research publication and the wide requirement to register clinical trials. The EQUATOR (Enhancing the QUAlity and Transparency Of health Research Network is an international initiative set up to advance high quality reporting of health research studies; it promotes good reporting practices including the wider implementation of reporting guidelines. EQUATOR provides free online resources http://www.equator-network.org supported by education and training activities and assists in the development of robust reporting guidelines. This paper outlines EQUATOR's goals and activities and offers suggestions for organizations and individuals involved in health research on how to strengthen research reporting.

Teamwork and clinical error reporting among nurses in Korean hospitals.

Science.gov (United States)

Hwang, Jee-In; Ahn, Jeonghoon

2015-03-01

To examine levels of teamwork and its relationships with clinical error reporting among Korean hospital nurses. The study employed a cross-sectional survey design. We distributed a questionnaire to 674 nurses in two teaching hospitals in Korea. The questionnaire included items on teamwork and the reporting of clinical errors. We measured teamwork using the Teamwork Perceptions Questionnaire, which has five subscales including team structure, leadership, situation monitoring, mutual support, and communication. Using logistic regression analysis, we determined the relationships between teamwork and error reporting. The response rate was 85.5%. The mean score of teamwork was 3.5 out of 5. At the subscale level, mutual support was rated highest, while leadership was rated lowest. Of the participating nurses, 522 responded that they had experienced at least one clinical error in the last 6 months. Among those, only 53.0% responded that they always or usually reported clinical errors to their managers and/or the patient safety department. Teamwork was significantly associated with better error reporting. Specifically, nurses with a higher team communication score were more likely to report clinical errors to their managers and the patient safety department (odds ratio = 1.82, 95% confidence intervals [1.05, 3.14]). Teamwork was rated as moderate and was positively associated with nurses' error reporting performance. Hospital executives and nurse managers should make substantial efforts to enhance teamwork, which will contribute to encouraging the reporting of errors and improving patient safety. Copyright © 2015. Published by Elsevier B.V.

The accuracy of clinical malaria case reporting at primary health care facilities in Honiara, Solomon Islands

Directory of Open Access Journals (Sweden)

Kunimitsu Ayano

2009-04-01

government statistics in regard to clinical malaria case reporting. Moreover, the high numbers of patients, illegible writing, the disuse of tally sheets, and insufficient resources at some clinics are likely to be related to the increase in the discrepancy. The clinical malaria case reporting at the local clinic level therefore urgently needs improvement, in order to achieve both better malaria surveillance and to also eventually eliminate this disease in the Solomon Islands.

Increasing clinical presence of mobile communication technology: avoiding the pitfalls.

Science.gov (United States)

Visvanathan, Akila; Gibb, Alan P; Brady, Richard R W

2011-10-01

Mobile communication technologies are employed in many diverse areas of healthcare delivery to provide improved quality and efficiency of communication and facilitate increased rapidity of data or information transfer. Mobile phones enable healthcare professionals to possess a portable platform from which to provide many healthcare-related applications and are a popular means to directly communicate with colleagues and patients. As involvement of mobile communication technology in healthcare delivery continues to rapidly expand, there are also important considerations of relevance to patient safety and security as a result. Here, we review the previous evidence of reported clinical risks associated with mobile communication technology, such as electromagnetic interference, confidentiality and data security, distraction/noise, infection control, and cross contamination. In conclusion, although mobile phones provide much putative potential improvement to healthcare delivery, further evaluation and research are required to both inform and protect health professionals and users of such technology in the healthcare environment and provide the evidence base to support the provision of clear and comprehensive guidelines.

Developments in clinical trials: a Pharma Matters report.

Science.gov (United States)

Arjona, A; Nuskey, B; Rabasseda, X; Arias, E

2014-08-01

As the pharmaceutical industry strives to meet the ever-increasing complexity of drug development, new technology in clinical trials has become a beacon of hope. With big data comes the promise of accelerated patient recruitment, real-time monitoring of clinical trials, bioinformatics empowerment of quicker phase progression, and the overwhelming benefits of precision medicine for select trials. Risk-based monitoring stands to benefit as well. With a strengthening focus on centralized data by the FDA and industry's transformative initiative, TransCelerate, a new era in trial risk mitigation has begun. The traditional method of intensive on-site monitoring is becoming a thing of the past as statistical, real-time analysis of site and trial-wide data provides the means to monitor with greater efficiency and effectiveness from afar. However, when it comes to big data, there are challenges that lie ahead. Patient privacy, commercial investment protection, technology woes and data variability are all limitations to be met with considerable thought. At the Annual Meeting of the American Academy of Dermatology this year, clinical trials on psoriasis, atopic dermatitis and other skin diseases were discussed in detail. This review of clinical research reports on novel therapies for psoriasis and atopic dermatitis reveals the impact of these diseases and the drug candidates that have been successful in phase II and III studies. Data-focused highlights of novel dermatological trials, as well as real-life big data approaches and an insight on the new methodology of risk-based monitoring, are all discussed in this edition of Developments in Clinical Trials. Copyright 2014 Prous Science, S.A.U. or its licensors. All rights reserved.

Quality assessment of reports on clinical trials in the Journal of Hepatology

DEFF Research Database (Denmark)

Gluud, C; Nikolova, D

1998-01-01

Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make...... a qualitative assessment of the reporting....

Promoting integrity of shift report by applying ISBAR principles among nursing students in clinical placement

Directory of Open Access Journals (Sweden)

Pang Weng Ian

2017-01-01

Full Text Available Shift report is an essential method for nursing staff to carry out health care communication. The most important purpose of the shift report is to ensure the safety of patients and to provide continuous care. Nursing students are inadequate of clinical experience and rational organization during patient care. They may not be able to handle the critically ill patients and pass the messages to the following nursing staff. ISBAR (Identify, Situation, Background, Assessment and Recommendation tool is increasingly being utilized as a format for structured shift report communication. In this study, a scale of ISBAR principles is designed to provide students with self-assessment and teachers with evaluation, in a way to improve nursing students’ self-awareness of shift report. Hopefully, with the use of the scale of ISBAR, nursing students are able to complete shift report in systemic integrity and orderliness during clinical placement.

The STAR Data Reporting Guidelines for Clinical High Altitude Research.

Science.gov (United States)

Brodmann Maeder, Monika; Brugger, Hermann; Pun, Matiram; Strapazzon, Giacomo; Dal Cappello, Tomas; Maggiorini, Marco; Hackett, Peter; Bärtsch, Peter; Swenson, Erik R; Zafren, Ken

2018-03-01

Brodmann Maeder, Monika, Hermann Brugger, Matiram Pun, Giacomo Strapazzon, Tomas Dal Cappello, Marco Maggiorini, Peter Hackett, Peter Baärtsch, Erik R. Swenson, Ken Zafren (STAR Core Group), and the STAR Delphi Expert Group. The STARdata reporting guidelines for clinical high altitude research. High AltMedBiol. 19:7-14, 2018. The goal of the STAR (STrengthening Altitude Research) initiative was to produce a uniform set of key elements for research and reporting in clinical high-altitude (HA) medicine. The STAR initiative was inspired by research on treatment of cardiac arrest, in which the establishment of the Utstein Style, a uniform data reporting protocol, substantially contributed to improving data reporting and subsequently the quality of scientific evidence. The STAR core group used the Delphi method, in which a group of experts reaches a consensus over multiple rounds using a formal method. We selected experts in the field of clinical HA medicine based on their scientific credentials and identified an initial set of parameters for evaluation by the experts. Of 51 experts in HA research who were identified initially, 21 experts completed both rounds. The experts identified 42 key parameters in 5 categories (setting, individual factors, acute mountain sickness and HA cerebral edema, HA pulmonary edema, and treatment) that were considered essential for research and reporting in clinical HA research. An additional 47 supplemental parameters were identified that should be reported depending on the nature of the research. The STAR initiative, using the Delphi method, identified a set of key parameters essential for research and reporting in clinical HA medicine.

Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

Science.gov (United States)

Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D

2015-03-01

Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision

Transparency in the reporting of in vivo pre-clinical pain research: The relevance and implications of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines.

Science.gov (United States)

Rice, Andrew S C; Morland, Rosemary; Huang, Wenlong; Currie, Gillian L; Sena, Emily S; Macleod, Malcolm R

2017-12-29

Clear reporting of research is crucial to the scientific process. Poorly designed and reported studies are damaging not only to the efforts of individual researchers, but also to science as a whole. Standardised reporting methods, such as those already established for reporting randomised clinical trials, have led to improved study design and facilitated the processes of clinical systematic review and meta-analysis. Such standards were lacking in the pre-clinical field until the development of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines. These were prompted following a survey which highlighted a widespread lack of robust and consistent reporting of pre-clinical in vivo research, with reports frequently omitting basic information required for study replication and quality assessment. The resulting twenty item checklist in ARRIVE covers all aspects of experimental design with particular emphasis on bias reduction and methodological transparency. Influential publishers and research funders have already adopted ARRIVE. Further dissemination and acknowledgement of the importance of these guidelines is vital to their widespread implementation. Conclusions and implications Wide implementation of the ARRIVE guidelines for reporting of in vivo preclinical research, especially pain research, are essential for a much needed increased transparency and quality in publishing such research. ARRIVE will also positively influence improvements in experimental design and quality, assist the conduct of accurate replication studies of important new findings and facilitate meta-analyses of preclinical research.

Clinical outcomes of the inclusion of the therapeutic drug monitoring report in the electronic clinical record

Directory of Open Access Journals (Sweden)

Marina Sáez Belló

2016-12-01

Full Text Available Objectives: To assess the inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record (ECR. Method: An observational ambispective cohort study with a duration of 149 days: PRE (retrospective, 49 days with the TDMR printed in paper, and POST (prospective, 100 days with the TDMR included in the ECR. Exclusion criteria: Patients not hospitalized, applications for Therapeutic Drug Monitoring by Critical Care and Neonatal Units, as well as monitoring with an objective other than dose adjustment. Variables: Number of TDMRs prepared, number of patients admitted with TDMR, time of delay for treatment adjustment, defined as the number of adjustments made to the treatment within over or under 24 hours from the time of TDMR preparation, and medication errors (MEs associated with said delay, as well as the degree of acceptance of the TDMR. Results: 690 TDMRs were conducted in 391 patients, 339 in PRE (n = 206 and 351 in POST (n = 185. The number of treatment modifications made in under 24 hours increased from 73.9% in PRE to 87.3% in POST [RR = 1.2 (CI95% = 0.97-1.43. We identified 35 patients with ME, 9.7% of them in PRE and 8.1% in POST (RR = 0.84 (CI95% = 0.44-1.58]. The degree of acceptance of the pharmacist recommendation increased from 53.3% in PRE to 68.3% in POST [RR = 1.3 (CI95% = 1.02- 1.62]. Conclusions: The inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record increases the degree of acceptance of recommendations, and may reduce the delay in treatment modifications, reducing MEs and improving the process quality in terms of efficacy and safety

First reports of clinical pharmacokinetics in Nigeria | Michael ...

African Journals Online (AJOL)

It is the basis of therapeutic drug monitoring with the ultimate goal of keeping drugs safe. This branch of pharmacology has become the most relevant to the sub-specialty of clinical pharmacology. First reports of Clinical Pharmacokinetics in Nigeria can be credited to two gifted Nigerians, Prof Ayodele O. Iyun and Prof Lateef ...

Clinical use of metal post- case report

OpenAIRE

Denkova, Natasa; Zlatanovska, Katerina; Kovacevska, Ivona; Nedelkova, Marija; Denkov, Nikola

2016-01-01

Background: Some teeth are severely mutilated because of caries or trauma. In case of an evident horizontal loss of clinical crown, most of the teeth could be unable to retain the final restoration without some additional support. Among other means, after endodontic treatment the use of endodontic posts can now be avoided in many cases. Aim:The aim of this case report was to show our management on teeth with evident loss of clinical crown from caries without set a prosthetic rehabilitation...

Dental Student Hand Hygiene Decreased With Increased Clinical Experience.

Science.gov (United States)

Yaembut, Nanmanas; Ampornaramveth, Ruchanee S; Pisarnturakit, Pagaporn P; Subbalekha, Keskanya

2016-01-01

To investigate the effectiveness, related knowledge, attitudes, and practices of hand hygiene (HH) among dental students with different levels of clinical experience. This was a cross-sectional analytical study. Bacterial samples on the participants' hands were obtained using a swab technique before and after handwashing, for oral surgical procedures. After culturing, the colony-forming units were counted. Self-reported questionnaires reflecting the knowledge, attitudes, and practices related to HH were completed by the participants. This study was performed in a primary oral health care institution, Faculty of Dentistry, Chulalongkorn University (Bangkok, Thailand). Bacterial samples and self-reported questionnaires were collected in the Department of Oral and Maxillofacial Surgery. Bacterial culture was performed in the Department of Microbiology. The 120 participants comprised first, second, third-year clinical training students (CTs), and postgraduate dental students (PGs) (32, 34, 30, and 24 participants, respectively). More than 99% of the bacteria were eliminated from the participants' hands after handwashing. Significantly higher numbers of bacteria were recovered from the hands of the PGs compared with those of the CTs, and the hands of the third-year CTs compared with those of the first-year CTs (p < 0.001), after HH. The first-year CTs had the highest attitude scores, whereas the PGs had the lowest practice scores. The knowledge scores were similar in all groups. HH effectiveness, attitudes, and practices of dental students decreased as students gained more clinical experience, whereas knowledge did not. Our results suggest that HH instruction should be given throughout the duration of dental students' education. Copyright © 2016 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Decreasing Turnaround Time and Increasing Patient Satisfaction in a Safety Net Hospital-Based Pediatrics Clinic Using Lean Six Sigma Methodologies.

Science.gov (United States)

Jayasinha, Yasangi

2016-01-01

Increasingly, health care quality indicators are focusing on patient-centeredness as an indicator of performance. The National Quality Forum lists assessment of patient experience, often conducted using patient surveys, as a top priority. We developed a patient-reported time stamp data collection tool that was used to collect cycle times in a safety net hospital-based outpatient pediatrics clinic. Data were collected using patient-reported survey to obtain cycle times in Pediatric clinic, as well as qualitative and quantitative patient satisfaction data. Several rapid-cycle improvements were performed using Lean Six Sigma methodologies to reduce cycle time by eliminating waste and revise unnecessary processes to improve operational effectiveness and patient and staff satisfaction. A total of 94 surveys were collected and revealed average cycle time of 113 minutes. Our measured patient satisfaction rating was 87%. Discharge and check-in processes were identified as the least efficient and were targeted for intervention. Following implementation, the overall cycle time was decreased from 113 to 90 minutes. Patient satisfaction ratings increased from 87% to 95%. We demonstrate that using Lean Six Sigma tools can be invaluable to clinical restructuring and redesign and results in measurable, improved outcomes in care delivery.

Combining bimodal presentation schemes and buzz groups improves clinical reasoning and learning at morning report.

Science.gov (United States)

Balslev, Thomas; Rasmussen, Astrid Bruun; Skajaa, Torjus; Nielsen, Jens Peter; Muijtjens, Arno; De Grave, Willem; Van Merriënboer, Jeroen

2014-12-11

Abstract Morning reports offer opportunities for intensive work-based learning. In this controlled study, we measured learning processes and outcomes with the report of paediatric emergency room patients. Twelve specialists and 12 residents were randomised into four groups and discussed the same two paediatric cases. The groups differed in their presentation modality (verbal only vs. verbal + text) and the use of buzz groups (with vs. without). The verbal interactions were analysed for clinical reasoning processes. Perceptions of learning and judgment of learning were reported in a questionnaire. Diagnostic accuracy was assessed by a 20-item multiple-choice test. Combined bimodal presentation and buzz groups increased the odds ratio of clinical reasoning to occur in the discussion of cases by a factor of 1.90 (p = 0.013), indicating superior reasoning for buzz groups working with bimodal materials. For specialists, a positive effect of bimodal presentation was found on perceptions of learning (p presentation on diagnostic accuracy was noted in the specialists (p presentation and buzz group discussion of emergency cases improves clinicians' clinical reasoning and learning.

The importance of clinical case reports in research

Directory of Open Access Journals (Sweden)

Ricardo Pineda-Leguízamo

2018-04-01

Full Text Available Clinical case reports correspond to articles that have the lowest level of evidence within different research trials. However, not only are they common and significant in the medical field, but they have often been the basis the generation of research. The purpose of their publication can be scientific or educational. In general terms, the discovery of new diseases, the presentation of rare diseases, unusual forms of common diseases, the complications of a common treatment, or the effect (beneficial or adverse of a treatment, among other things, are narrated in these documents. Clinical case reports continue to be one of the most important sources of knowledge. The advent of a standardized guideline for the creation of this type of reports allows homogenizing the form and content of the cases intended to be described in the near future and, furthermore, will enable authors to have a reference when preparing this type of publications. Case reports are valuable resources of new and unusual information that can encourage and serve to conduct future research studies with a higher level of evidence.

The use of strapping to increase local pressure: reporting of a sub-bandage pressure study

Directory of Open Access Journals (Sweden)

Alison Hopkins

2013-04-01

Full Text Available High compression is the gold standard for venous ulcer management. This brief report presents the results of a sub-bandage pressure study that investigated the pressures received from compression therapy in the region of the retromalleolal fossa. The study tested the hypothesis that therapeutic compression is not achieved behind the malleolus. The results confirm this, showing that less that 5-mmHg sub-bandage pressure is achieved despite high compression at the B1 level. This report demonstrates that the application of novel strapping below the malleolus substantially increases the compression at rest, standing and dorsiflexion. The clinical implications of this are discussed.

Teamwork and Clinical Error Reporting among Nurses in Korean Hospitals

OpenAIRE

Jee-In Hwang, PhD; Jeonghoon Ahn, PhD

2015-01-01

Purpose: To examine levels of teamwork and its relationships with clinical error reporting among Korean hospital nurses. Methods: The study employed a cross-sectional survey design. We distributed a questionnaire to 674 nurses in two teaching hospitals in Korea. The questionnaire included items on teamwork and the reporting of clinical errors. We measured teamwork using the Teamwork Perceptions Questionnaire, which has five subscales including team structure, leadership, situation monitori...

Summary reports for key Hoodia clinical studies

CSIR Research Space (South Africa)

Maharaj, VJ

2011-12-01

Full Text Available The CSIR has acquired the reports to 14 clinical studies in which Hoodia has been assesses, using crude extracts and concentrated active ingredients formulated in a number of different ways. In many of the studies Hoodia was found to be generally...

The Role of Technical Advances in the Adoption and Integration of Patient-Reported Outcomes in Clinical Care

Science.gov (United States)

Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.

2016-01-01

Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135

Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

Science.gov (United States)

Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

2016-05-01

Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. Published by Elsevier Inc.

Temporomandibular joint dysfunction syndrome. A clinical report.

Science.gov (United States)

Passero, P L; Wyman, B S; Bell, J W; Hirschey, S A; Schlosser, W S

1985-08-01

We have presented two clinical case reports of patients with TMJ dysfunction syndrome as an example of coordinated treatments between dentists and physical therapists. The clinical profiles of these patients with craniocervical pain were compiled from comprehensive physical therapy and dental-orthopedic evaluations. The significance of the relationship between the rest position of the mandible and forward head posture has been shown by the changes observed after correction of the postural deviations and vertical resting dimensions by dental treatments and physical therapy. Additional research is necessary to determine long-term effects of this combined approach in TMJ dysfunction syndrome.

A brief simulation intervention increasing basic science and clinical knowledge

Directory of Open Access Journals (Sweden)

Maria L. Sheakley

2016-04-01

Full Text Available Background: The United States Medical Licensing Examination (USMLE is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. Purpose: To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. Methods: This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l=515 and the intervention group received lecture plus a simulation exercise (nl+s=1,066. Assessment included summative exam questions (n=4 that were scored as pass/fail (≥75%. USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Results: Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003. Discussion: Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

Science.gov (United States)

Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

2017-12-01

Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

Interventions to increase the use of electronic health information by healthcare practitioners to improve clinical practice and patient outcomes.

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Fiander, Michelle; McGowan, Jessie; Grad, Roland; Pluye, Pierre; Hannes, Karin; Labrecque, Michel; Roberts, Nia W; Salzwedel, Douglas M; Welch, Vivian; Tugwell, Peter

2015-03-14

There is a large volume of health information available, and, if applied in clinical practice, may contribute to effective patient care. Despite an abundance of information, sub-optimal care is common. Many factors influence practitioners' use of health information, and format (electronic or other) may be one such factor. To assess the effects of interventions aimed at improving or increasing healthcare practitioners' use of electronic health information (EHI) on professional practice and patient outcomes. We searched The Cochrane Library (Wiley), MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO), and LISA (EBSCO) up to November 2013. We contacted researchers in the field and scanned reference lists of relevant articles. We included studies that evaluated the effects of interventions to improve or increase the use of EHI by healthcare practitioners on professional practice and patient outcomes. We defined EHI as information accessed on a computer. We defined 'use' as logging into EHI. We considered any healthcare practitioner involved in patient care. We included randomized, non-randomized, and cluster randomized controlled trials (RCTs, NRCTs, CRCTs), controlled clinical trials (CCTs), interrupted time series (ITS), and controlled before-and-after studies (CBAs).The comparisons were: electronic versus printed health information; EHI on different electronic devices (e.g. desktop, laptop or tablet computers, etc.; cell / mobile phones); EHI via different user interfaces; EHI provided with or without an educational or training component; and EHI compared to no other type or source of information. Two review authors independently extracted data and assessed the risk of bias for each study. We used GRADE to assess the quality of the included studies. We reassessed previously excluded studies following our decision to define logins to EHI as a measure of professional behavior. We reported results in natural units. When possible, we calculated and reported median effect size

Jogging Therapy for Hikikomori Social Withdrawal and Increased Cerebral Hemodynamics: A Case Report.

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Nishida, Masaki; Kikuchi, Senichiro; Fukuda, Kazuhito; Kato, Satoshi

2016-01-01

Severe social withdrawal, called hikikomori, has drawn increased public attention. However, an optimal clinical approach and strategy of treatment has not been well established. Here, we report a case of hikikomori for which an exercise intervention using jogging therapy was effective, showing cerebral hemodynamic improvement. The patient was a 20 year old Japanese male who was hospitalized in order to evaluate and treat severe social withdrawal. Although depressive and anxiety symptoms partially subsided with sertraline alone, social withdrawal persisted due to a lack of self confidence. With his consent, we implemented exercise therapy with 30 minutes of jogging three times a week for three months. We did not change the pharmacotherapy, and his social withdrawal remarkably improved with continuous jogging exercise. Using near infrared spectroscopy to evaluate hemodynamic alteration, bilateral temporal hemodynamics considerably increased after the three-month jogging therapy. Regarding exercise therapy for mental illness, numerous studies have reported the effectiveness of exercise therapy for major depression. This case implied, however, that the applicability of exercise therapy is not limited to major depressive disorder. Jogging therapy may contribute to reinforcing self confidence associated with "resilience" in conjunction with neurophysiological modulation of neural networks.

Assessing quality of reports on randomized clinical trials in nursing journals.

Science.gov (United States)

Parent, Nicole; Hanley, James A

2009-01-01

Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

Media Reporting of Practice-Changing Clinical Trials in Oncology: A North American Perspective.

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Andrew, Peter; Vickers, Michael M; O'Connor, Stephen; Valdes, Mario; Tang, Patricia A

2016-03-01

Media reporting of clinical trials impacts patient-oncologist interactions. We sought to characterize the accuracy of media and Internet reporting of practice-changing clinical trials in oncology. The first media articles referencing 17 practice-changing clinical trials were collected from 4 media outlets: newspapers, cable news, cancer websites, and industry websites. Measured outcomes were media reporting score, social media score, and academic citation score. The media reporting score was a measure of completeness of information detailed in media articles as scored by a 15-point scoring instrument. The social media score represented the ubiquity of social media presence referencing 17 practice-changing clinical trials in cancer as determined by the American Society of Clinical Oncology in its annual report, entitled Clinical Cancer Advances 2012; social media score was calculated from Twitter, Facebook, and Google searches. The academic citation score comprised total citations from Google Scholar plus the Scopus database, which represented the academic impact per clinical cancer advance. From 170 media articles, 107 (63%) had sufficient data for analysis. Cohen's κ coefficient demonstrated reliability of the media reporting score instrument with a coefficient of determination of 94%. Per the media reporting score, information was most complete from industry, followed by cancer websites, newspapers, and cable news. The most commonly omitted items, in descending order, were study limitations, exclusion criteria, conflict of interest, and other. The social media score was weakly correlated with academic citation score. Media outlets appear to have set a low bar for coverage of many practice-changing advances in oncology, with reports of scientific breakthroughs often omitting basic study facts and cautions, which may mislead the public. The media should be encouraged to use a standardized reporting template and provide accessible references to original source

Spontaneously Reported Symptoms by Informants Are Associated with Clinical Severity in Dementia Help-Seekers.

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Xu, Jia-Qi; Choy, Jacky C P; Tang, Jennifer Y M; Liu, Tian-Yin; Luo, Hao; Lou, Vivian W Q; Lum, Terry Y S; Wong, Gloria H Y

2017-09-01

To investigate the predictive value of symptoms of dementia that the person or an informant noticed spontaneously in determining the clinical severity of dementia. Cross-sectional. Community-based open-referral dementia assessment service in Hong Kong between 2005 and 2013. Help-seekers for dementia assessment service and their informants (N = 965 dyads). Participants underwent a clinical dementia interview based on the Clinical Dementia Rating. Spontaneous complaints that the person and the informant made that had prompted their help-seeking of groups with interview results suggestive of no impairment, mild cognitive impairment, and dementia were compared. Logistic regression was used to evaluate the predictive value of spontaneous complaints for clinical severity. Independent raters blinded to clinical results coded spontaneously reported symptoms into theoretical themes: memory, executive function, language, time and place orientation, neuropsychiatric, mood, and avolition. Memory problems were the most frequently reported complaints for participants (87.7%) and their informants (95.5%), followed by self-reported language (33.0%) and informant-reported orientation (33.0%) difficulties. Informant-reported but not self-reported symptoms predicted clinical severity. Compared with the persons themselves, informants reported more pervasive symptoms corresponding to clinical severity. Persons with dementia self-reported fewer types of symptoms than their healthy or mildly impaired counterparts. Spontaneously reported language and orientation symptoms by the informant distinguished persons with mild or worse dementia (P < .001, Nagelkerke coefficient of determination = 29.7%, percentage correct 85.6%). The type and pervasiveness of symptoms spontaneously that informants reported predicted clinical severity. This may provide a quick reference for triage. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Clinical outcome of increased flexion gap after total knee arthroplasty. Can controlled gap imbalance improve knee flexion?

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Ismailidis, P; Kuster, M S; Jost, B; Giesinger, K; Behrend, H

2017-06-01

Increased range of motion (ROM) while maintaining joint stability is the goal of modern total knee arthroplasty (TKA). A biomechanical study has shown that small increases in flexion gap result in decreased tibiofemoral force beyond 90° flexion. The purpose of this paper was to investigate clinical implications of controlled increased flexion gap. Four hundred and four TKAs were allocated into one of two groups and analysed retrospectively. In the first group (n = 352), flexion gap exceeded extension gap by 2.5 mm, while in the second group (n = 52) flexion gap was equal to the extension gap. The procedures were performed from 2008 to 2012. The patients were reviewed 12 months postoperatively. Objective clinical results were assessed for ROM, mediolateral and sagittal stability. Patient-reported outcome measures were the WOMAC score and the Forgotten Joint Score (FJS-12). After categorizing postoperative flexion into three groups (poor < 90°, satisfactory 91°-119°, good ≥ 120°) significantly more patients in group 1 achieved satisfactory or good ROM (p = 0.006). Group 1 also showed a significantly higher mean FJS-12 (group 1: 73, group 2: 61, p = 0.02). The mean WOMAC score was 11 in the first and 14 in the second group (n.s.). Increase in flexion gap did not influence knee stability. The clinical relevance of this study is that a controlled flexion gap increase of 2.5 mm may have a positive effect on postoperative flexion and patient satisfaction after TKA. Neither knee stability in the coronal and sagittal planes nor complications were influenced by a controlled increase in flexion gap. III.

Patient-reported symptoms during radiotherapy : Clinically relevant symptom burden in patients treated with palliative and curative intent.

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Körner, Philipp; Ehrmann, Katja; Hartmannsgruber, Johann; Metz, Michaela; Steigerwald, Sabrina; Flentje, Michael; van Oorschot, Birgitt

2017-07-01

The benefits of patient-reported symptom assessment combined with integrated palliative care are well documented. This study assessed the symptom burden of palliative and curative-intent radiation oncology patients. Prior to first consultation and at the end of RT, all adult cancer patients planned to receive fractionated percutaneous radiotherapy (RT) were asked to answer the Edmonton Symptom Assessment Scale (ESAS; nine symptoms from 0 = no symptoms to 10 = worst possible symptoms). Mean values were used for curative vs. palliative and pre-post comparisons, and the clinical relevance was evaluated (symptom values ≥ 4). Of 163 participating patients, 151 patients (90.9%) completed both surveys (116 curative and 35 palliative patients). Before beginning RT, 88.6% of palliative and 72.3% of curative patients showed at least one clinically relevant symptom. Curative patients most frequently named decreased general wellbeing (38.6%), followed by tiredness (35.0%), anxiety (32.4%), depression (30.0%), pain (26.3%), lack of appetite (23.5%), dyspnea (17.8%), drowsiness (8.0%) and nausea (6.1%). Palliative patients most frequently named decreased general wellbeing (62.8%), followed by pain (62.8%), tiredness (60.0%), lack of appetite (40.0%), anxiety (38.0%), depression (33.3%), dyspnea (28.5%), drowsiness (25.7%) and nausea (14.2%). At the end of RT, the proportion of curative and palliative patients with a clinically relevant symptom had increased significantly to 79.8 and 91.4%, respectively; whereas the proportion of patients reporting clinically relevant pain had decreased significantly (42.8 vs. 62.8%, respectively). Palliative patients had significantly increased tiredness. Curative patients reported significant increases in pain, tiredness, nausea, drowsiness, lack of appetite and restrictions in general wellbeing. Assessment of patient-reported symptoms was successfully realized in radiation oncology routine. Overall, both groups showed a high symptom

Patient-reported symptoms during radiotherapy. Clinically relevant symptom burden in patients treated with palliative and curative intent

International Nuclear Information System (INIS)

Koerner, Philipp; Ehrmann, Katja; Hartmannsgruber, Johann; Metz, Michaela; Steigerwald, Sabrina; Flentje, Michael; Oorschot, Birgitt van

2017-01-01

The benefits of patient-reported symptom assessment combined with integrated palliative care are well documented. This study assessed the symptom burden of palliative and curative-intent radiation oncology patients. Prior to first consultation and at the end of RT, all adult cancer patients planned to receive fractionated percutaneous radiotherapy (RT) were asked to answer the Edmonton Symptom Assessment Scale (ESAS; nine symptoms from 0 = no symptoms to 10 = worst possible symptoms). Mean values were used for curative vs. palliative and pre-post comparisons, and the clinical relevance was evaluated (symptom values ≥ 4). Of 163 participating patients, 151 patients (90.9%) completed both surveys (116 curative and 35 palliative patients). Before beginning RT, 88.6% of palliative and 72.3% of curative patients showed at least one clinically relevant symptom. Curative patients most frequently named decreased general wellbeing (38.6%), followed by tiredness (35.0%), anxiety (32.4%), depression (30.0%), pain (26.3%), lack of appetite (23.5%), dyspnea (17.8%), drowsiness (8.0%) and nausea (6.1%). Palliative patients most frequently named decreased general wellbeing (62.8%), followed by pain (62.8%), tiredness (60.0%), lack of appetite (40.0%), anxiety (38.0%), depression (33.3%), dyspnea (28.5%), drowsiness (25.7%) and nausea (14.2%). At the end of RT, the proportion of curative and palliative patients with a clinically relevant symptom had increased significantly to 79.8 and 91.4%, respectively; whereas the proportion of patients reporting clinically relevant pain had decreased significantly (42.8 vs. 62.8%, respectively). Palliative patients had significantly increased tiredness. Curative patients reported significant increases in pain, tiredness, nausea, drowsiness, lack of appetite and restrictions in general wellbeing. Assessment of patient-reported symptoms was successfully realized in radiation oncology routine. Overall, both groups showed a high symptom burden

Increasing antimicrobial resistance in clinical isolates of Staphylococcus intermedius group bacteria and emergence of MRSP in the UK.

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Beever, L; Bond, R; Graham, P A; Jackson, B; Lloyd, D H; Loeffler, A

2015-02-14

Frequencies of antimicrobial resistance were determined amongst 14,555 clinical Staphylococcus intermedius group (SIG) isolates from UK dogs and cats to estimate resistance trends and quantify the occurrence of meticillin-resistant Staphylococcus pseudintermedius (MRSP). Reports from two diagnostic laboratories (13,313 general submissions, 1242 referral centre only submissions) were analysed retrospectively (2003/2006-2012). MRSP were defined by phenotypic resistance to meticillin and concurrent broad β-lactam resistance; a subset was confirmed genetically (SIG-specific nuc and mecA). Trends were analysed by Cochran-Armitage test. Resistance remained below 10 per cent for cefalexin, amoxicillin-clavulanic acid and the fluoroquinolones. Increasing resistance trends were seen in both laboratories for ampicillin/amoxicillin (both PResistance to cefalexin increased over time in referral hospital isolates (Presistance to important antimicrobials was identified overtime and the emergence of MRSP from UK clinical cases was confirmed. Attention to responsible use of antibacterial therapy in small animal practice is urgently needed. British Veterinary Association.

Report of the results of the International Clinical Cytometry Society and American Society for Clinical Pathology workload survey of clinical flow cytometry laboratories.

Science.gov (United States)

Wolniak, Kristy; Goolsby, Charles; Choi, Sarah; Ali, Asma; Serdy, Nina; Stetler-Stevenson, Maryalice

2017-11-01

Thorough review of current workload, staffing, and testing practices in clinical laboratories allows for optimization of laboratory efficiency and quality. This information is largely missing with regard to clinical flow cytometry laboratories. The purpose of this survey is to provide comprehensive, current, and accurate data on testing practices and laboratory staffing in clinical laboratories performing flow cytometric studies. Survey data was collected from flow cytometry laboratories through the ASCP website. Data was collected on the workload during a 1-year time period of full-time and part-time technical and professional (M.D./D.O./Ph.D. or equivalent) flow cytometry employees. Workload was examined as number of specimens and tubes per full time equivalent (FTE) technical and professional staff. Test complexity, test result interpretation, and reporting practices were also evaluated. There were 205 respondent laboratories affiliated predominantly with academic and health system institutions. Overall, 1,132 FTE employees were reported with 29% professional FTE employees and 71% technical. Fifty-one percent of the testing performed was considered high complexity and 49% was low complexity. The average number of tubes per FTE technologist was 1,194 per year and the average number of specimens per FTE professional was 1,659 per year. The flow cytometry reports were predominantly written by pathologists (57%) and were typically written as a separate report (58%). This survey evaluates the overall status of the current practice of clinical flow cytometry and provides a comprehensive dataset as a framework to help laboratory departments, directors, and managers make appropriate, cost-effective staffing decisions. © 2016 International Clinical Cytometry Society. © 2016 International Clinical Cytometry Society.

Development and implementation of a patient reported outcome intervention (QLIC-ON PROfile) in clinical paediatric oncology practice.

NARCIS (Netherlands)

Engelen, V.; Haverman, L.; Koopman, H.; Schouten-van Meeteren, N.; Meijer, E.M.M.; Vrijmoet-Wiersma, J.; Dijk, E.M. van; Last, B.; Detmar, S.; Grootenhuis, M.

2010-01-01

OBJECTIVE: The use of patient reported outcomes (PRO) in routine clinical practice is becoming increasingly common, but there is limited knowledge about the development and implementation of PRO. The objective of the current paper is to provide a thorough description of the development and

Development and implementation of a patient reported outcome intervention (QLIC-ON PROfile) in clinical paediatric oncology practice

NARCIS (Netherlands)

Engelen, V.; Haverman, L.; Koopman, H.; Schouten-van Meeteren, A.Y.N.; Meijer-van den Bergh, E.; Vrijmoet-Wiersma, J.; van Dijk, E.M.; Last, B.F.; Detmar, S.; Grootenhuis, M.

2010-01-01

Objective: The use of patient reported outcomes (PRO) in routine clinical practice is becoming increasingly common, but there is limited knowledge about the development and implementation of PRO. The objective of the current paper is to provide a thorough description of the development and

Case report: clinical and postmortem findings in four cows with rib fracture

OpenAIRE

Braun, Ueli; Warislohner, Sonja; Hetzel, Udo; Nuss, Karl

2017-01-01

BACKGROUND: Published reports of rib fractures in adult cattle are limited to the occurrence of chronic rib swellings caused by calluses, which are unremarkable from a clinical standpoint, whereas studies identifying clinical signs of rib fractures were not found in a literature search. This report describes the clinical and postmortem findings in four cows with rib fractures. CASE PRESENTATION: The 13th rib was fractured in three cows and the 11th rib in the remaining cow; three fractures...

Ethics of safety reporting of a clinical trial

Directory of Open Access Journals (Sweden)

Amrita Sil

2017-01-01

Full Text Available Clinical trial related injury and serious adverse events (SAE are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR whereas if causal association is not yet established it is termed adverse event (AE. An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI, sponsor and Chairperson of the Ethics Committee (EC within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.

Rapid increase in cystic volume of an anaplastic astrocytoma misdiagnosed as neurocysticercosis: A case report

Science.gov (United States)

Li, Hong-Jiang; Han, Hong-Xiu; Feng, Dong-Fu

2016-01-01

Reports describing a rapid increase in the cystic volume of anaplastic astrocytoma (AA) in a short time frame are rare. The present study reports the case of a 68-year-old male who was admitted to the No. 9 People's Hospital, Shanghai Jiaotong University School of Medicine (Shanghai, China), with a small cystic brain lesion and positive immunological testing for cysticercosis. Head magnetic resonance imaging (MRI) showed a cystic lesion, 6 mm in diameter, in the left frontal lobe. Neurocysticercosis was suspected and the patient was treated with a clinical trial of albendazole and steroids. A period of 25 days later, the patient's condition had deteriorated, and MRI revealed a cystic lesion in the left frontal lobe; thereafter, the cystic lesion was removed and a diagnosis of AA was established. The tumor was soft, ivory white and gelatinous due to myxoid degeneration. In this case, tumor-related angiogenesis and microvascular extravasation (blood-brain barrier disruption) may have been the main cause of the rapid increase in the cystic volume in such a short time frame. The similarity of the glioma and cysticercus antigens may have been the cause of the positive reactions in the cystic fluid. The present study reports the rare occurrence of a rapid increase of cystic volume and potential diagnostic difficulties. PMID:27698865

'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO Data in Trials to Inform Clinical Practice. A Systematic Review.

Directory of Open Access Journals (Sweden)

Angus G K McNair

Full Text Available The CONSORT extension for patient reported outcomes (PROs aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice.The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30% and 6 (16% combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14% and 1 (7% primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73% and 3 (20% achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2.It is recommended that single papers, with detailed PRO rationale and integrated PRO and

Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics

Directory of Open Access Journals (Sweden)

Maureen Sanderson

2017-02-01

Full Text Available Abstract Background Human papillomavirus (HPV infection has been causally linked to six cancers, and many disproportionately affect minorties. This study reports on the development and effectiveness of an intervention aimed at increasing HPV vaccine uptake among African American and Hispanic pediatric patients in safety-net clinics. Methods Formative research, community engagement, and theory guided development of the intervention. A clustered, non-randomized controlled pragmatic trial was conducted in four clinics providing healthcare for the underserved in Tennessee, U.S., with two intervention sites and two usual care sites. Patients aged 9-18 years (N = 408 and their mothers (N = 305 enrolled, with children clustered within families. The intervention consisted of two provider/staff training sessions and provision of patient education materials, consisting of a video/flyer promoting HPV vaccine. Medical records were reviewed before/after the initial visit and after 12 months. Results At the initial visit, provision of patient education materials and provider recommendation were higher at intervention sites versus usual care sites, and receipt of HPV vaccine was higher at intervention sites (45.4% versus 32.9% but not significantly after adjusting for patient’s age and mother’s education. Provider recommendation, but not education materials, increased the likelihood of vaccine receipt at the initial visit, although over one-third of intervention mothers cited the flyer/video as motivating vaccination. Completion of the 3-dose series at follow-up was lower in the intervention arm. Conclusions Future interventions should combine patient education, intensive provider/staff education, and patient reminders. Research should compare patient education focusing on HPV vaccine only versus all adolescent vaccines. Trial registration Retrospectively registered with ClinicalTrials.gov NCT02808832 , 9/12/16

Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry.

Science.gov (United States)

Perlis, Roy H; Perlis, Clifford S; Wu, Yelena; Hwang, Cindy; Joseph, Megan; Nierenberg, Andrew A

2005-10-01

Financial conflict of interest has been reported to be prevalent in clinical trials in general medicine and associated with a greater likelihood of reporting results favorable to the intervention being studied. The extent and implications of industry sponsorship and financial conflict of interest in psychiatric clinical trials have not been investigated, to the authors' knowledge. The authors examined funding source and author financial conflict of interest in all clinical trials published in the American Journal of Psychiatry, the Archives of General Psychiatry, the Journal of Clinical Psychopharmacology, and the Journal of Clinical Psychiatry between 2001 and 2003. Among 397 clinical trials identified, 239 (60%) reported receiving funding from a pharmaceutical company or other interested party, and 187 studies (47%) included at least one author with a reported financial conflict of interest. Among the 162 randomized, double-blind, placebo-controlled studies examined, those that reported conflict of interest were 4.9 times more likely to report positive results; this association was significant only among the subset of pharmaceutical industry-funded studies. Author conflict of interest appears to be prevalent among psychiatric clinical trials and to be associated with a greater likelihood of reporting a drug to be superior to placebo.

Improved clinical documentation leads to superior reportable outcomes: An accurate representation of patient's clinical status.

Science.gov (United States)

Elkbuli, Adel; Godelman, Steven; Miller, Ashley; Boneva, Dessy; Bernal, Eileen; Hai, Shaikh; McKenney, Mark

2018-05-01

Clinical documentation can be an underappreciated. Trauma Centers (TCs) are now routinely evaluated for quality performance. TCs with poor documentation may not accurately reflect actual injury burden or comorbidities and can impact accuracy of mortality measures. Markers exist to adjust crude death rates for injury severity: observed over expected deaths (O/E) adjust for injury; Case Mix Index (CMI) reflects disease burden, and Severity of Illness (SOI) measures organ dysfunction. We aim to evaluate the impact of implementing a Clinical Documentation Improvement Program (CDIP) on reported outcomes. Review of 2-years of prospectively collected data for trauma patients, during the implementation of CDIP. A two-group prospective observational study design was used to evaluate the pre-implementation and the post-implementation phase of improved clinical documentation. T-test and Chi-Squared were used with significance defined as p deaths out of 1419 (3.45%), while post-implementation period, had 38 deaths out of 1454 (2.61%), (non-significant). There was however, a significant difference between O/E ratios. In the pre-phase, the O/E was 1.36 and 0.70 in the post-phase (p < 0.001). The two groups also differed on CMI with a pre-group mean of 2.48 and a post-group of 2.87 (p < 0.001), indicating higher injury burden in the post-group. SOI started at 2.12 and significantly increased to 2.91, signifying more organ system dysfunction (p < 0.018). Improved clinical documentation results in improved accuracy of measures of mortality, injury severity, and comorbidities and a more accurate reflection in O/E mortality ratios, CMI, and SOI. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Increased clinical anticipation with maternal transmission in benign adult familial myoclonus epilepsy in Japan.

Science.gov (United States)

Hitomi, Takefumi; Kobayashi, Katsuya; Jingami, Naoto; Nakagawa, Tomokazu; Imamura, Hisaji; Matsumoto, Riki; Kondo, Takayuki; Chin, Kazuo; Takahashi, Ryosuke; Ikeda, Akio

2013-12-01

We recently reported clinical anticipation in Japanese families with benign adult familial myoclonus epilepsy (BAFME). However, it remains unknown whether clinical anticipation is predominantly associated with paternal or maternal transmission. We investigated the relationship between gender of the transmitting parent and clinical anticipation in nine BAFME families. Clinical anticipation regarding either cortical tremor or generalised seizures was observed in all 12 parent/child pairs (8 mother/child pairs and 4 father/child pairs). Moreover, a higher degree of clinical anticipation was associated with maternal transmission than with paternal transmission (p=0.03). Although a causative gene for BAFME still remains unknown, our finding suggests that BAFME and diseases with unstable expanding repeats, including those in non-coding regions, might share a similar molecular mechanism because such diseases often show clinical anticipation with maternal transmission.

Patients Reporting Ritual Abuse in Childhood: A Clinical Syndrome. Report of 37 Cases.

Science.gov (United States)

Young, Walter C.; And Others

1991-01-01

Thirty-seven adult dissociative disorder patients who reported ritual abuse in childhood by satanic cults are described. A clinical syndrome is presented that includes dissociative states with satanic overtones, posttraumatic stress disorder, survivor guilt, unusual fears, and substance abuse. Questions concerning reliability, credibility, and…

Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms

Directory of Open Access Journals (Sweden)

Ramakrishnan K

2013-12-01

Full Text Available Karthik Ramakrishnan,1 T Christopher Bond,1 Ami Claxton,1 Vipan C Sood,2 Maria Kootsikas,2 Wendy Agnese,2 Scott Sibbel11DaVita Clinical Research, Minneapolis, MN, USA; 2Mitsubishi Tanabe Pharma Corporation, Jersey City, NJ, USAAbstract: One of the most common conditions affecting end-stage renal disease (ESRD patients undergoing hemodialysis (HD is pruritus. Studies report that itchy and dry skin, symptoms of pruritus, affect 40%–90% of ESRD patients. Yet, in clinical practice the condition is often underdiagnosed resulting in inadequate management and an underappreciated impact on patient outcomes. Two retrospective analyses were conducted: a preliminary analysis of ESRD patients with pruritus symptoms (n=73,124 undergoing HD or peritoneal dialysis at a large dialysis provider and a subsequent detailed analysis of a homogenous subset of patients undergoing in-center HD (n=38,315. The goal was to better understand the clinical burden of pruritus as it relates to patient characteristics, quality of life, medication use, and HD compliance. This population is commonly burdened by multiple comorbidities and related polypharmaceutical management; identifying the relationship of pruritus to these ailments can help guide future research and resource allocation. The detailed analysis confirmed trends observed in the preliminary analysis: 30% reported being "moderately" to "extremely bothered" by itchiness. The HD patient population with the highest severity of self-reported pruritus also had a consistent trend in overall increased resource utilization – higher monthly doses of erythropoietin-stimulating agents (53,397.1 to 63,405.4 units and intravenous (IV iron (237.2 to 247.6 units and higher use of IV antibiotics (14.1% to 20.7%, as well as poorer quality-of-life measures (25-point reductions in Burden of Disease Score and Effects on Daily Life subscales of the Kidney Disease Quality of Life-36 survey. These results highlight the need to better

Does electronic clinical microbiology results reporting influence medical decision making: a pre- and post-interview study of medical specialists.

Science.gov (United States)

Bruins, Marjan J; Ruijs, Gijs J H M; Wolfhagen, Maurice J H M; Bloembergen, Peter; Aarts, Jos E C M

2011-03-30

Clinicians view the accuracy of test results and the turnaround time as the two most important service aspects of the clinical microbiology laboratory. Because of the time needed for the culturing of infectious agents, final hardcopy culture results will often be available too late to have a significant impact on early antimicrobial therapy decisions, vital in infectious disease management. The clinical microbiologist therefore reports to the clinician clinically relevant preliminary results at any moment during the diagnostic process, mostly by telephone. Telephone reporting is error prone, however. Electronic reporting of culture results instead of reporting on paper may shorten the turnaround time and may ensure correct communication of results. The purpose of this study was to assess the impact of the implementation of electronic reporting of final microbiology results on medical decision making. In a pre- and post-interview study using a semi-structured design we asked medical specialists in our hospital about their use and appreciation of clinical microbiology results reporting before and after the implementation of an electronic reporting system. Electronic reporting was highly appreciated by all interviewed clinicians. Major advantages were reduction of hardcopy handling and the possibility to review results in relation to other patient data. Use and meaning of microbiology reports differ significantly between medical specialties. Most clinicians need preliminary results for therapy decisions quickly. Therefore, after the implementation of electronic reporting, telephone consultation between clinician and microbiologist remained the key means of communication. Overall, electronic reporting increased the workflow efficiency of the medical specialists, but did not have an impact on their decision-making. © 2011 Bruins et al; licensee BioMed Central Ltd.

Does electronic clinical microbiology results reporting influence medical decision making: a pre- and post-interview study of medical specialists

Directory of Open Access Journals (Sweden)

Bloembergen Peter

2011-03-01

Full Text Available Abstract Background Clinicians view the accuracy of test results and the turnaround time as the two most important service aspects of the clinical microbiology laboratory. Because of the time needed for the culturing of infectious agents, final hardcopy culture results will often be available too late to have a significant impact on early antimicrobial therapy decisions, vital in infectious disease management. The clinical microbiologist therefore reports to the clinician clinically relevant preliminary results at any moment during the diagnostic process, mostly by telephone. Telephone reporting is error prone, however. Electronic reporting of culture results instead of reporting on paper may shorten the turnaround time and may ensure correct communication of results. The purpose of this study was to assess the impact of the implementation of electronic reporting of final microbiology results on medical decision making. Methods In a pre- and post-interview study using a semi-structured design we asked medical specialists in our hospital about their use and appreciation of clinical microbiology results reporting before and after the implementation of an electronic reporting system. Results Electronic reporting was highly appreciated by all interviewed clinicians. Major advantages were reduction of hardcopy handling and the possibility to review results in relation to other patient data. Use and meaning of microbiology reports differ significantly between medical specialties. Most clinicians need preliminary results for therapy decisions quickly. Therefore, after the implementation of electronic reporting, telephone consultation between clinician and microbiologist remained the key means of communication. Conclusions Overall, electronic reporting increased the workflow efficiency of the medical specialists, but did not have an impact on their decision-making.

Factors influencing mother-child reports of depressive symptoms and agreement among clinically referred depressed youngsters in Hungary.

Science.gov (United States)

Kiss, Eniko; Gentzler, Amy M; George, Charles; Kapornai, Krisztina; Tamás, Zsuzsanna; Kovacs, Maria; Vetró, Agnes

2007-06-01

Psychiatric assessments of children typically involve two informants, the child and the parent. Understanding discordance in their reports has been of interest to clinicians and researchers. We examine differences between mothers' and children's report of children's depressive symptom severity, and factors that may influence their reports and level of agreement. We hypothesized that agreement between mother and child would improve if (1) the mother is depressed, due to improved recall of mood congruent symptoms, (2) the child is older, due to better social-cognitive and communication skills, and (3) the child is a female. Subjects were 354 children (158 girls; mean age 11.69 years, SD: 2.05 years) with Major Depressive Disorder. Depressive symptoms were evaluated by a semi-structured interview separately with the mother and the child. Agreement on symptom severity was based on concordance of the presence and extent of symptoms. Maternal reports were significantly higher than their son's but not daughters'. Girls, particularly with increasing age, reported higher levels of symptoms; however mothers' reports were not affected by child sex or age. Maternal depression predicted more severe symptom reports for both children and mothers. Agreement between the mother and the child increased as children got older. The same clinician interviewed the mother and the child, which might inflate rates of agreement. However, this method mirrors clinical evaluation. During a clinical interview one must consider the age and sex of the child and the depressive state of the mother in assimilating information about the child.

Case report: clinical and postmortem findings in four cows with rib fracture.

Science.gov (United States)

Braun, Ueli; Warislohner, Sonja; Hetzel, Udo; Nuss, Karl

2017-02-06

Published reports of rib fractures in adult cattle are limited to the occurrence of chronic rib swellings caused by calluses, which are unremarkable from a clinical standpoint, whereas studies identifying clinical signs of rib fractures were not found in a literature search. This report describes the clinical and postmortem findings in four cows with rib fractures. The 13th rib was fractured in three cows and the 11th rib in the remaining cow; three fractures were on the right and one on the left side. Clinical and postmortem findings varied considerably, and percussion of the rib cage elicited a pain response in only one cow. One cow had generalised peritonitis because of perforation of the rumen by the fractured rib. One cow was recumbent because of pain and became a downer cow, and two other cows had bronchopneumonia, which was a sequel to osteomyelitis of the fracture site in one. In the absence of a history of trauma, the diagnosis of rib fracture based on clinical signs alone is difficult. Although rib fractures undoubtedly are very painful, the four cases described in this report suggest that they are difficult to diagnose in cattle because associated clinical signs are nonspecific.

Integrating patient reported outcomes with clinical cancer registry data: a feasibility study of the electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) system.

Science.gov (United States)

Ashley, Laura; Jones, Helen; Thomas, James; Newsham, Alex; Downing, Amy; Morris, Eva; Brown, Julia; Velikova, Galina; Forman, David; Wright, Penny

2013-10-25

Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both Pplanning and for targeting service provision.

Minimum reporting standards for clinical research on groin pain in athletes

DEFF Research Database (Denmark)

Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

2015-01-01

Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...... are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes...

Clinical signs, diagnosis, and case reports of Vaccinia virus infections

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Daniela Carla Medeiros Silva

Full Text Available Vaccinia virus is responsible for a zoonosis that usually affects cattle and human beings in Brazil. The initial clinical signs of the infection are focal red skin areas, fever, and general symptoms similar to those of a cold. Then, pustules and ulcerated lesions surrounded by edema and erythema follow, as well as local lymphadenopathy that can last for weeks. Cure and healing of the lesions occur over several weeks, leaving a typical scar in the skin of people and animals affected. The infection definitive diagnosis is made through morphological characterization of the virus by use of electron microscopy, followed by PCR for specific viral genes. Since 1963, circulating orthopoxviruses in infectious outbreaks in several regions of Brazil have been reported. Later, the etiological agent of those infections was characterized as samples of Vaccinia virus. In addition, the widespread use of those viruses in research laboratories and mass vaccination of militaries have contributed to increase the cases of those infections worldwide. Thus, several epidemiological and clinical studies are required, as well as studies of viral immunology, public health, and economic impact, because little is known about those Vaccinia virus outbreaks in Brazil.

Implementing video cases in clinical paediatric teaching increases medical students' self-assessed confidence

DEFF Research Database (Denmark)

Malon, Michelle; Cortes, Dina; Andersen, Jesper

2014-01-01

INTRODUCTION: Use of video cases in clinical education is rarely used systematically. MATERIAL AND METHODS: Medical students (n = 127) reported by questionnaire whether they had or had not seen a bedside case of each of 22 specific clinical conditions during their five-week clinical course...... the intervention, this share was 75% (218/289) (p = 0.06). Furthermore, internal as well as external examiners found video cases valuable, but the use of videos did not change the average examination grade. CONCLUSION: A video case supplement to teaching in clinical paediatrics was considered to be of value...... for teaching. We were successful in establishing an educational resource that students considered useful. Internal and external examiners found that a short video case was a valuable supplementary tool during the oral examination. FUNDING: The University of Copenhagen funded the study. TRIAL REGISTRATION...

Utilization of Patient-Reported Outcomes to Guide Symptom Management during Stereotactic Body Radiation Therapy for Clinically Localized Prostate Cancer

Directory of Open Access Journals (Sweden)

Malika Danner

2017-10-01

Full Text Available IntroductionUtilization of patient-reported outcomes (PROs to guide symptom management during radiation therapy is increasing. This study focuses on the use of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP as a tool to assess urinary and bowel bother during stereotactic body radiation therapy (SBRT and its utility in guiding medical management.MethodsBetween September 2015 and January 2017, 107 patients with clinically localized prostate cancer were treated with 35–36.25 Gy via SBRT in five fractions. PROs were assessed using EPIC-CP 1 h prior to the first fraction and after each subsequent fraction. Symptom management medications were prescribed based on the physician clinical judgment or if patients reported a moderate to big problem. Clinical significance was assessed using a minimally important difference of 1/2 SD from baseline score.ResultsA median baseline EPIC-CP urinary symptom score of 1.5 significantly increased to 3.7 on the day of the final treatment (p < 0.0001. Prior to treatment, 9.3% of men felt that their overall urinary function was a moderate to big problem that increased to 28% by the end of the fifth treatment. A median baseline EPIC-CP bowel symptom score of 0.3 significantly increased to 1.4 on the day of the final treatment (p < 0.0001. Prior to treatment, 1.9% of men felt that their overall bowel function was a moderate to big problem that increased to 3.7% by the end of the fifth treatment. The percentage of patients requiring an increased dose of alpha-antagonist increased to 47% by the end of treatment, and an additional 28% of patients required a short steroid taper to manage moderate to big urinary problems. Similarly, the percentage of patients requiring antidiarrheals reached 12% by the fifth treatment.ConclusionDuring the course of SBRT, an increasing percentage of patients experienced clinically significant symptoms many of which required medical management

Cervical spondylotic myelopathy: the clinical phenomenon and the current pathobiology of an increasingly prevalent and devastating disorder.

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Kalsi-Ryan, Sukhvinder; Karadimas, Spyridon K; Fehlings, Michael G

2013-08-01

Cervical spondylotic myelopathy (CSM) is a common disorder involving chronic progressive compression of the cervical spinal cord due to degenerative disc disease, spondylosis, or other degenerative pathology. CSM is the most common form of spinal cord impairment and causes functional decline leading to reduced independence and quality of life. Despite a sound understanding of the disease process, clinical presentation and management, a universal definition of CSM and a standardized index of severity are not currently used universally. Work is required to develop a definition and establish clinical predictors of progression to improve management of CSM. Despite advances in decompressive and reconstructive surgery, patients are often left with residual disability. Gaps in knowledge of the pathobiology of CSM have limited therapeutic advances to complement surgery. Although the histopathologic and pathophysiologic similarities between CSM and traumatic spinal cord injury have long been acknowledged, the unique pathomechanisms of CSM remain unexplored. Increased efforts to elucidate CSM pathobiology could lead to the discovery of novel therapeutic targets for human CSM and other spinal cord diseases. Here, the natural history of CSM, epidemiology, clinical presentation, and current methods of clinical management are reported, along with the current state of basic scientific research in the field.

A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm.

Science.gov (United States)

McDonald, Cameron J; Kalisch Ellett, Lisa M; Barratt, John D; Caughey, Gillian E

2014-12-01

Concerns with the safety profiles of the newer anticoagulants have been raised because of differences in treatment populations between pre-marketing studies (randomized controlled trials) and clinical practice. Little is known about the potential safety issues and the reporting in spontaneous adverse event databases associated with rivaroxaban. To analyse spontaneous adverse event reports associated with the oral anticoagulant rivaroxaban from Australia, Canada and the USA; and to examine concomitant medicine use that may increase the risk of adverse events. Spontaneous adverse event report databases from Australia, Canada and the USA were examined for all reports of adverse events associated with rivaroxaban and concomitant medicines from 1 August 2005 to 31 March 2013. Disproportionality analysis (the proportional reporting ratio [PRR] and reporting odds ratio [ROR]) was conducted for quantitative detection of signals, using the US database. There were 244 spontaneous adverse event reports associated with rivaroxaban from Australia, 536 from Canada and 1,638 from the USA. Reporting of haemorrhage (any type) was common, ranging from 30.7% for Australia to 37.5% for Canada. Gastrointestinal haemorrhage was the most commonly reported haemorrhage, accounting for 13.9% of Australian, 16.4% of Canadian and 11.1% of US adverse event reports. Positive signals were confirmed in the US data (haemorrhage [any type] PRR 11.93, χ (2) 4,414.78 and ROR 13.41, 95% confidence interval [CI] 12.13-14.81; gastrointestinal haemorrhage PRR 12.52, χ (2) 2,018.48 and ROR 13.15, 95% CI 11.36-15.21). Reporting of concomitant use of medicines with the potential to increase bleeding risk ranged from 63.7% in Australia to 89.2% in Canada. A large proportion of adverse event reports for rivaroxaban were associated with use of concomitant medicines, which may have increased the risk of adverse events-in particular, haemorrhage. Increased awareness of a patient's comorbidity and associated

Likelihood of Null Effects of Large NHLBI Clinical Trials Has Increased over Time.

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Robert M Kaplan

Full Text Available We explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI funded trials has increased over time.We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.17 of 30 studies (57% published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8% trials published after 2000 (χ2=12.2,df= 1, p=0.0005. There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings.The number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.

Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement.

Science.gov (United States)

2014-10-01

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which creates a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant after ≥20 weeks' gestation) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples

Differential Reinforcement of Alternative Behavior Increases Resistance to Extinction: Clinical Demonstration, Animal Modeling, and Clinical Test of One Solution

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Mace, F. Charles; McComas, Jennifer J.; Mauro, Benjamin C.; Progar, Patrick R.; Taylor, Bridget; Ervin, Ruth; Zangrillo, Amanda N.

2010-01-01

Basic research with pigeons on behavioral momentum suggests that differential reinforcement of alternative behavior (DRA) can increase the resistance of target behavior to change. This finding suggests that clinical applications of DRA may inadvertently increase the persistence of target behavior even as it decreases its frequency. We conducted…

Effects of clinical breakpoint changes in CLSI guidelines 2010/2011 and EUCAST guidelines 2011 on antibiotic susceptibility test reporting of Gram-negative bacilli.

Science.gov (United States)

Hombach, Michael; Bloemberg, Guido V; Böttger, Erik C

2012-03-01

The aim of this study was to analyse the effects of clinical breakpoint changes in CLSI 2010 and 2011 guidelines and EUCAST 2011 guidelines on antibiotic susceptibility testing (AST) reports. In total, 3713 non-duplicate clinical isolates of Enterobacteriaceae, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Acinetobacter baumannii were analysed. Inhibition zone diameters were determined for β-lactams, carbapenems, fluoroquinolones, aminoglycosides and trimethoprim/sulfamethoxazole. CLSI 2009-11 and EUCAST 2011 clinical breakpoints were applied. Changes in resistance as defined per the guidelines affected individual species and drug classes differently. The cefepime resistance rate in Escherichia coli and Enterobacter cloacae increased from 2.1% and 1.3% to 8.2% and 6.9%, respectively, applying CLSI 2009-11 versus EUCAST 2011 guidelines. Ertapenem resistance rates in E. cloacae increased from 2.6% with CLSI 2009 to 7.2% for CLSI 2010 and 2011, and to 10.1% when applying EUCAST 2011. Cefepime and meropenem resistance rates in P. aeruginosa increased from 12.2% and 20.6% to 19.8% and 27.7%, respectively, comparing CLSI 2009-11 with EUCAST 2011. Tobramycin and gentamicin resistance rates in A. baumannii increased from 15.9% and 25.4% to 34.9% and 44.4% applying CLSI 2009-11 versus EUCAST 2011. Higher resistance rates reported due to breakpoint changes in CLSI and EUCAST guidelines will result in increasing numbers of Gram-negative bacilli reported as multidrug resistant. AST reports classifying amoxicillin/clavulanic acid, cefepime or carbapenem resistance will lead clinicians to use alternative agents. Upon implementation of the EUCAST guidelines, laboratories should be aware of the implications of modified drug susceptibility testing reports on antibiotic prescription policies.

Eating epilepsy: clinical and neuro image aspects - case report

International Nuclear Information System (INIS)

Buchpiguel, Carlos A.; Yacubian, Elza Marcia T.; Fiore, Lia Arno; Jorge, Carmen Lisa; Yamaga, Liliam I.; Watanabe, Tomoco; Bacheschi, Luis A.; Scaff, Milberto; Magalhaes, Alvaro E.A.

1994-01-01

Eating epilepsy is an uncommon form of reflex epilepsy. The authors present a case report of a patient with clinical diagnosis of eating epilepsy who was submitted to clinical tests, neuroimaging studies (MRI and SPECT) and surface EEG. Multiple intercritical EEGs showed sharp discharges in the posterior left temporal area. The MRI did not show any abnormality. The intercritical brain SPECT showed clear hypoperfusion in the posterior left temporal area; so confirming the epileptogenic focus in producing the partial complex seizures triggered by eating. (author)

Core Data Necessary for Reporting Clinical Trials on Nutrition in Infancy

NARCIS (Netherlands)

Koletzko, Berthold; Fewtrell, Mary; Gibson, Robert; van Goudoever, Johannes B.; Hernell, Olle; Shamir, Raanan; Szajewska, Hania

2015-01-01

This paper presents an updated and revised summary of the 'core data set' that has been proposed to be recorded and reported in all clinical trials on infant nutrition by the recently formed Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT). This core

Unusual clinical presentation of rare case of vaginal leiomyoma: a case report

OpenAIRE

Ishrat Zuber; Purnima K. Nadkarni; Aditi A. Nadkarni; Akshay Nadkarni

2016-01-01

Primary vaginal leiomyoma are rare and usually arise from anterior vaginal wall, approximately 330 cases of vaginal fibroid reported in world literature. Vaginal myoma usually presented as discharge per vaginum, abnormal bleeding, pain lower abdomen, dyspareunia etc. We report a case of primary vaginal leiomyoma arising from lateral vaginal wall which is presented clinically as pain in hip joint and radiating to ipsilateral leg which is unusual clinical presentation creating diagnostic dilemm...

Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

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Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

2015-09-01

An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

Increased incidence of thyroid cancer in Navarra (Spain). Evolution and clinical characteristics, 1986-2010.

Science.gov (United States)

Rojo Álvaro, Jorge; Bermejo Fraile, Begoña; Menéndez Torre, Edelmiro; Ardanaz, Eva; Guevara, Marcela; Anda Apiñániz, Emma

The latest published studies show an increased incidence of thyroid cancer worldwide. The aim of this study was to analyze the changes in the incidence of thyroid cancer in Navarra and its clinical presentation regarding sex, histological subtype and size over the last 25 years. Thyroid cancer incidence rates were calculated on the basis of data from the Cancer Registry of Navarra during 1986-2010. Clinical data were obtained from the historical cohort of the Hospital Registry of Cancer of Navarra, which includes all the new cases of differentiated thyroid carcinoma diagnosed and treated in the public health network of this Community in that period. The overall incidence of thyroid cancer in Navarra increased over the last 25 years, with an increase in the adjusted rate in men from 2.24 (1986-1990) to 5.85 (2006-2010) per 100,000 population/year (P<.001) and in women from 9.05 to 14.04, respectively (P<.001). This increase occurs only in papillary carcinoma. The clinical characteristics of 739 patients with differentiated thyroid cancer were studied. The mean age at diagnosis increased over the years and the predominance of women (about 80%) remains stable. Mean tumor size decreased over the five-year periods from 30.9 to 22.5mm (P<.001), the proportion of microcarcinomas (T1a) increased from 8.8% to 30% (P<.001) and, despite this increase, there were no statistical differences in the TNM stage at diagnosis during the study period. The distribution of histological variants of papillary and follicular carcinoma did not change over 25 years. During the period studied, the incidence of thyroid cancer increased in Navarra in both sexes. The increase occurred only in papillary carcinoma, without changes in the distribution of his histological variants. The increase in the proportion of T1a tumors is remarkable, but the TNM stage distribution was maintained. These results suggest an increase in the diagnosis of thyroid microcarcinomas due to changes in clinical practice

The behaviours of nurses that increase student accountability for learning in clinical practice: An integrative review.

Science.gov (United States)

Perry, Christina; Henderson, Amanda; Grealish, Laurie

2018-06-01

To identify nurses' behaviours that promote student accountability for learning in clinical practice. Health care services are experiencing significant strain in meeting clinical education requirements of increasing numbers of nursing students enrolled in undergraduate nursing programs. Internationally, the transition to university based education for nurses has seen the emergence of issues for busy clinicians trying to manage increasing workloads with responsibility for student learning. An understanding of what types of supervisor behaviours promote student accountability for learning, may support clinicians to more effectively manage their dual roles of clinical care and student support. An integrative approach was adopted for this review. A search of the Cumulative Index of Nursing and Allied Health Literature, Pubmed, Scopus and Embase was undertaken, limited to articles published between 2000 and March 2017. Whittemore and Knafls' (2005) framework for conducting integrative reviews was used to ensure a methodological and rigorous approach. Nine studies were considered. Behaviours emerged in relation to four themes including: belongingness associated with a genuine partnership; empowerment and increasing student self-efficacy; trust linked to increasing and staged independence; and balancing clinical and educational requirements. Behaviours of nurses significantly influence students' accountability for learning and accordingly, their ability to be adequately prepared for professional nursing practice. Understanding behaviours that impact on students' approach to clinical placement can guide nurses in their approach to facilitating student learning, in particular, behaviours that increase student responsibility and independence over the continuum of clinical education. Copyright © 2018 Elsevier Ltd. All rights reserved.

Progress in increasing electronic reporting of laboratory results to public health agencies--United States, 2013.

Science.gov (United States)

2013-09-27

Electronic reporting of laboratory results to public health agencies can improve public health surveillance for reportable diseases and conditions by making reporting more timely and complete. Since 2010, CDC has provided funding to 57 state, local, and territorial health departments through the Epidemiology and Laboratory Capacity for Infectious Diseases cooperative agreement to assist with improving electronic laboratory reporting (ELR) from clinical and public health laboratories to public health agencies. As part of this agreement, CDC and state and large local health departments are collaborating to monitor ELR implementation in the United States by developing data from each jurisdiction regarding total reporting laboratories, laboratories sending ELR by disease category and message format, and the number of ELR laboratory reports compared with the total number of laboratory reports. At the end of July 2013, 54 of the 57 jurisdictions were receiving at least some laboratory reports through ELR, and approximately 62% of 20 million laboratory reports were being received electronically, compared with 54% in 2012. Continued progress will require collaboration between clinical laboratories, laboratory information management system (LIMS) vendors, and public health agencies.

Advancing medicine one research note at a time: the educational value in clinical case reports.

Science.gov (United States)

Cabán-Martinez, Alberto J; Beltrán, Wilfredo F García

2012-07-06

A case report--a brief written note that describes unique aspects of a clinical case--provides a significant function in medicine given its rapid, succinct, and educational contributions to scientific literature and clinical practice. Despite the growth of, and emphasis on, randomized clinical trials and evidenced-based medicine, case reports continue to provide novel and exceptional knowledge in medical education. The journal BMC Research Notes introduces a new "case reports" section to provide the busy clinician with a forum in which to document any authentic clinical case that provide educational value to current clinical practice. The aim is for this article type to be reviewed, wherever possible, by specialized Associate Editors for the journal, in order to provide rapid but thorough decision making. New ideas often garnered by and documented in case reports will support the advancement of medical science--one research note at a time.

High School Students' Self-Reported Use of School Clinics and Nurses

Science.gov (United States)

Harper, Christopher R.; Liddon, Nicole; Dunville, Richard; Habel, Melissa A.

2016-01-01

Access to school health clinics and nurses has been linked with improved student achievement and health. Unfortunately, no studies have examined how many students report using school clinics or nurses and for which services. This study addressed this gap with data from a nationally representative sample of 15- to 25-year-olds. Respondents who…

An official American thoracic society workshop report: developing performance measures from clinical practice guidelines.

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Kahn, Jeremy M; Gould, Michael K; Krishnan, Jerry A; Wilson, Kevin C; Au, David H; Cooke, Colin R; Douglas, Ivor S; Feemster, Laura C; Mularski, Richard A; Slatore, Christopher G; Wiener, Renda Soylemez

2014-05-01

Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care.

Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design?

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Jennifer Ai-Lian Woo

2015-03-01

Full Text Available Purpose: Stereotactic body radiation therapy (SBRT is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO endpoints for clinical trials for early stage prostate cancer RT is lacking. To aid in trial design, this study presents PROs over 36 months following SBRT for clinically localized prostate cancer. Methods: 174 hormone-naïve patients were treated with 35-36.25 Gy SBRT in 5 fractions. Patients completed the EPIC-26 questionnaire at baseline and all follow-ups; the proportion of patients developing a clinically significant decline in each EPIC domain was determined. The minimally important difference (MID was defined as a change of one-half SD from the baseline. Per RTOG 0938, we examined the percentage of patients who reported decline in EPIC urinary summary score of >2 points and EPIC bowel summary score of >5 points from baseline to one year. Results: 174 patients received SBRT with minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline in EPIC urinary/bowel scores was 34%/30%, 40%/32.2%, and 32.8%/21.5% at 6, 12, and 36 months. The percentage of patients reporting decline in the EPIC urinary summary score of >2 points was 43.2%, 51.6% and 41.8% at 6, 12, and 36 months. The percentage of patients reporting decline in EPIC bowel domain summary score of >5 points was 29.6% 29% and 22.4% at 6, 12, and 36 months. Conclusion: Our treatment protocol meets the RTOG 0938 criteria for advancing to a Phase III trial compared to conventionally fractionated RT. Between 12-36 months, the proportion of patients reporting decrease in both EPIC urinary and bowel scores declined, suggesting late improvement in these domains. Further investigation is needed to elucidate 1 which domains bear the greatest influence on post-treatment QOL, and 2 at what time point PRO endpoint(s should be assessed.

Implementation of an Integrated Orthopedic Curriculum to Increase Clinical and Procedural Competency amongst Pediatric Residents

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2017-04-05

to Increase Clinical and Procedural Competency Amongst Pediatric Residents presented at/published to APPD Conference, Anaheim, CA, 5-8 April 2017 in...Increase Clinical and Procedural Competency amongst Pediatric Residents 7. FUNDING RECEIVED FOR THIS STUDY? 0 YES l8] t-’O FUNDING SOURCE 8. DO YOU NEED...and Procedural Competency amongst Pediatric Residents Sarah Nelin MD, Taneishia Jones, MD, Jason Beachler MD, Michelle Lawson MD, Bryan Lawson, MD

Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

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S. Nicole Culos-Reed

2012-01-01

Full Text Available Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.

Improving the reporting of clinical trials of infertility treatments (IMPRINT): modifying the CONSORT statement†‡.

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Legro, Richard S; Wu, Xiaoke; Barnhart, Kurt T; Farquhar, Cynthia; Fauser, Bart C J M; Mol, Ben

2014-10-10

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and

Gender bias in clinical case reports: A cross-sectional study of the "big five" medical journals.

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Pascale Allotey

Full Text Available Gender bias in medical journals can affect the science and the benefit to patients. It has never been investigated in clinical case reports. The oversight is important because of the role clinical case reports play in hypothesis generation and medical education. We investigated contemporary gender bias in case reports for the highest ranked journals in general and internal medicine.PubMed case reports data from 2011 to 2016 were extracted for the Annals of Internal Medicine, British Medical Journal, the Journal of the American Medical Association, The Lancet, and New England Journal of Medicine. The gender of the patients were identified and a text analysis of the Medical Subject Headings conducted.A total of 2,742 case reports were downloaded and 2,582 (95.6% reports contributed to the final analysis. A pooled analysis showed a statistically significant gender bias against female case reports (0.45; 95%CI: 0.43-0.47. The Annals of Internal Medicine was the only journal with a point estimate (non significant in the direction of a bias against male patients. The text analysis identified no substantive difference in the focus of the case reports and no obvious explanation for the bias.Gender bias, previously identified in clinical research and in clinical authorship, extends into the patients presented in clinical case reports. Whether it is driven by authors or editors is not clear, but it likely contributes to and supports an overall male bias of clinical medicine.

Using Patient-Reported Information to Improve Clinical Practice.

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Schlesinger, Mark; Grob, Rachel; Shaller, Dale

2015-12-01

To assess what is known about the relationship between patient experience measures and incentives designed to improve care, and to identify how public policy and medical practices can promote patient-valued outcomes in health systems with strong financial incentives. Existing literature (gray and peer-reviewed) on measuring patient experience and patient-reported outcomes, identified from Medline and Cochrane databases; evaluations of pay-for-performance programs in the United States, Europe, and the Commonwealth countries. We analyzed (1) studies of pay-for-performance, to identify those including metrics for patient experience, and (2) studies of patient experience and of patient-reported outcomes to identify evidence of influence on clinical practice, whether through public reporting or private reporting to clinicians. First, we identify four forms of "patient-reported information" (PRI), each with distinctive roles shaping clinical practice: (1) patient-reported outcomes measuring self-assessed physical and mental well-being, (2) surveys of patient experience with clinicians and staff, (3) narrative accounts describing encounters with clinicians in patients' own words, and (4) complaints/grievances signaling patients' distress when treatment or outcomes fall short of expectations. Because these forms vary in crucial ways, each must be distinctively measured, deployed, and linked with financial incentives. Second, although the literature linking incentives to patients experience is limited, implementing pay-for-performance systems appears to threaten certain patient-valued aspects of health care. But incentives can be made compatible with the outcomes patients value if: (a) a sufficient portion of incentives is tied to patient-reported outcomes and experiences, (b) incentivized forms of PRI are complemented by other forms of patient feedback, and (c) health care organizations assist clinicians to interpret and respond to PRI. Finally, we identify roles for the

Hand hygiene-related clinical trials reported since 2010: a systematic review.

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Kingston, L; O'Connell, N H; Dunne, C P

2016-04-01

Considerable emphasis is currently placed on reducing healthcare-associated infection through improving hand hygiene compliance among healthcare professionals. There is also increasing discussion in the lay media of perceived poor hand hygiene compliance among healthcare staff. Our aim was to report the outcomes of a systematic search for peer-reviewed, published studies - especially clinical trials - that focused on hand hygiene compliance among healthcare professionals. Literature published between December 2009, after publication of the World Health Organization (WHO) hand hygiene guidelines, and February 2014, which was indexed in PubMed and CINAHL on the topic of hand hygiene compliance, was searched. Following examination of relevance and methodology of the 57 publications initially retrieved, 16 clinical trials were finally included in the review. The majority of studies were conducted in the USA and Europe. The intensive care unit emerged as the predominant focus of studies followed by facilities for care of the elderly. The category of healthcare worker most often the focus of the research was the nurse, followed by the healthcare assistant and the doctor. The unit of analysis reported for hand hygiene compliance was 'hand hygiene opportunity'; four studies adopted the 'my five moments for hand hygiene' framework, as set out in the WHO guidelines, whereas other papers focused on unique multimodal strategies of varying design. We concluded that adopting a multimodal approach to hand hygiene improvement intervention strategies, whether guided by the WHO framework or by another tested multimodal framework, results in moderate improvements in hand hygiene compliance. Copyright © 2015 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Look local: the value of cancer surveillance and reporting by American Indian clinics.

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Creswell, Paul D; Strickland, Rick; Stephenson, Laura; Pierce-Hudson, Kimmine; Matloub, Jacqueline; Waukau, Jerry; Adams, Alexandra; Kaur, Judith; Remington, Patrick L

2013-11-27

Cancer incidence and mortality rates for American Indians in the Northern Plains region of the United States are among the highest in the nation. Reliable cancer surveillance data are essential to help reduce this burden; however, racial data in state cancer registries are often misclassified, and cases are often underreported. We used a community-based participatory research approach to conduct a retrospective ascertainment of cancer cases in clinic medical records over a 9-year period (1995-2003) and compared the results with the state cancer registry to evaluate missing or racially misclassified cases. Six tribal and/or urban Indian clinics participated in the study. The project team consisted of participating clinics, a state cancer registry, a comprehensive cancer center, an American Indian/Alaska Native Leadership Initiative on Cancer, and a set of diverse organizational partners. Clinic personnel were trained by project staff to accurately identify cancer cases in clinic records. These records were then matched with the state cancer registry to assess misclassification and underreporting. Forty American Indian cases were identified that were either missing or misclassified in the state registry. Adding these cases to the registry increased the number of American Indian cases by 21.3% during the study period (P = .05). Our results indicate that direct reporting of cancer cases by tribal and urban Indian health clinics to a state cancer registry improved the quality of the data available for cancer surveillance. Higher-quality data can advance the efforts of cancer prevention and control stakeholders to address disparities in Native communities.

Cultural Competency Training to Increase Minority Enrollment into Radiation Therapy Clinical Trials-an NRG Oncology RTOG Study.

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Wells, Jessica S; Pugh, Stephanie; Boparai, Karan; Rearden, Jessica; Yeager, Katherine A; Bruner, Deborah W

2017-12-01

Despite initiatives to increase the enrollment of racial and ethnic minorities into cancer clinical trials in the National Cancer Institute National Cancer Clinical Trials Network (NCCTN), participation by Latino and African American populations remain low. The primary aims of this pilot study are (1) to develop a Cultural Competency and Recruitment Training Program (CCRTP) for physician investigators and clinical research associates (CRAs), (2) to determine if the CCRTP increases cultural competency scores among physician investigators and CRAs, and (3) to determine the impact of the CCRTP on minority patient recruitment into NRG Oncology Radiation Therapy Oncology Group (RTOG) clinical trials. Sixty-seven CRAs and physicians participated in an in-person or online 4-h CRRTP training. Five knowledge and attitude items showed significant improvements from pre- to post-training. A comparison between enrolling sites that did and did not participate in the CCRTP demonstrated a pre to 1-year post-incremental increase in minority accrual to clinical trials of 1.2 % among participating sites. While not statistically significant, this increase translated into an additional 300 minority patients accrued to NCCTN clinical trials in the year following the training from those sites who participated in the training.

Pyometra in a Great Dane: A Clinical Case Report

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Malik Abu Rafee

2015-04-01

Full Text Available A 4-year-old Great Dane was admitted with continuous sanguino-purulent vaginal discharge, distended abdomen, and cachexia. The dog was clinically diagnosed with pyometra and successfully cured by ovario-hysterectomy. This is the first case report of pyometra seen in as Great Dane in Bareilly, India.

Clinical trial registration and reporting: a survey of academic organizations in the United States.

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Mayo-Wilson, Evan; Heyward, James; Keyes, Anthony; Reynolds, Jesse; White, Sarah; Atri, Nidhi; Alexander, G Caleb; Omar, Audrey; Ford, Daniel E

2018-05-02

Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations. We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis. Eligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and

Rehabilitation of atrophic anophthalmic cavity with orthostatic ocular prosthesis: A clinical report.

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Amaral, C F; Cordeiro, J M; Emídio, T C S; Presotto, A G C; Barbosa, C M R

2016-10-01

The absence of the eyeball can generate psychosocial and facial harmony changes, such as atrophy of the muscles around it. In these cases, the use of an orthostatic prosthesis with expanding function fosters distension of the tissues for subsequent rehabilitation. This technique consists of making individual ocular prostheses with gradual enlargement of size. The aim of this following clinical report was to describe the technique used in the standing prosthetic rehabilitation of a patient, 73 years old, who underwent enucleation of the right eye as a result of glaucoma. Clinical and laboratory procedures were performed such as impression, adjusting curvature of the sclera, centering the pupil area and processing in heat-cured acrylic resin three prostheses made according to the expansion of the anophthalmic cavity. At the end of treatment, there was a considerable increase of the cavity, allowing for volume replacement similar to that existing in the patient's contralateral orbit, thus generating a satisfactory facial harmony. Copyright © 2016 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

Babesiosis in equines in Pakistan: a clinical report

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Asif Rashid

2009-09-01

Full Text Available Equine babesiosis is a tick-borne haematological disease of equidae that can affect acutely, subacutely and chronically. The disease is manifested by intermittent fever, anaemia, icterus and haemoglobinuria. The authors describe the clinical, haematological and therapeutic aspects of babesiosis in equines at two units in Kotley and at two units in Jehlum of the Remount Veterinary and Farms Corps (RVFC. Animals on these units showed the signs of illness. On clinical examination, intermittent temperature, increased respiratory rate, anaemia, lacrimation, conjunctivitis and pale mucous membranes were observed. Haematological examination revealed a decrease in red blood cell count and haemoglobin concentration, accompanied by an increase in total white blood cell count. Cases of babesiosis in horses were successfully treated with imidocarb dipropionate at a dose rate of 4 mg/kg body weight, administered intramuscularly four times at 72 h intervals, together with supportive therapy.

Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

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Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of

Dual cusped protostylid: Case report and clinical significance

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Preeti Bhattacharya

2016-01-01

Full Text Available Protostylids are superstructures on maxillary or mandibular molars, which have rarely been reported in literature, and the significance of their presence has also been underestimated. The dental practitioners may easily misdiagnose a tooth, with such conical tubercles as malformed tooth. Interestingly, this is neither a malformation nor an anomaly but rather an important morphological trait of an individual. Once in a while, one may come across such a distinct morphological trait without being able to diagnose. To the authors' best knowledge, only one similar case has been reported previously, and the second such case internationally. Bearing all such facts in mind, the authors attempt to educate the readers towards the existence of such a trait so that it can be identified and studied in larger numbers. Hence, it is the authors' endeavor to report an unusual case of dual cusped maxillary protostylid along with its clinical significance.

Characteristic clinical features of Aspergillus appendicitis: Case report and literature review.

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Gjeorgjievski, Mihajlo; Amin, Mitual B; Cappell, Mitchell S

2015-11-28

This work aims to facilitate diagnosing Aspergillus appendicitis, which can be missed clinically due to its rarity, by proposing a clinical pentad for Aspergillus appendicitis based on literature review and one new case. The currently reported case of pathologically-proven Aspergillus appendicitis was identified by computerized search of pathology database at William Beaumont Hospital, 1999-2014. Prior cases were identified by computerized literature search. Among 10980 pathology reports of pathologically-proven appendicitis, one case of Aspergillus appendicitis was identified (rate = 0.01%). A young boy with profound neutropenia, recent chemotherapy, and acute myelogenous leukemia presented with right lower quadrant pain, pyrexia, and generalized malaise. Abdominal computed tomography scan showed a thickened appendiceal wall and periappendiceal inflammation, suggesting appendicitis. Emergent laparotomy showed an inflamed, thickened appendix, which was resected. The patient did poorly postoperatively with low-grade-fevers while receiving antibacterial therapy, but rapidly improved after initiating amphotericin therapy. Microscopic examination of a silver stain of the appendectomy specimen revealed fungi with characteristic Aspergillus morphology, findings confirmed by immunohistochemistry. Primary Aspergillus appendicitis is exceptionally rare, with only 3 previously reported cases. All three cases presented with (1)-neutropenia, (2)-recent chemotherapy, (3)-acute leukemia, and (4)-suspected appendicitis; (5)-the two prior cases initially treated with antibacterial therapy, fared poorly before instituting anti-Aspergillus therapy. The current patient satisfied all these five criteria. Based on these four cases, a clinical pentad is proposed for Aspergillus appendicitis: clinically-suspected appendicitis, neutropenia, recent chemotherapy, acute leukemia, and poor clinical response if treated solely by antibacterial/anti-candidial therapy. Patients presenting with

Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

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Philipp Bruland

2016-11-01

Full Text Available Abstract Background Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Methods Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. Results The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Conclusions Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.

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Bruland, Philipp; McGilchrist, Mark; Zapletal, Eric; Acosta, Dionisio; Proeve, Johann; Askin, Scott; Ganslandt, Thomas; Doods, Justin; Dugas, Martin

2016-11-22

Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

Adverse event reporting in cancer clinical trial publications.

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Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

2014-01-10

Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

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Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

2015-10-01

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

Public Reporting of Primary Care Clinic Quality: Accounting for Sociodemographic Factors in Risk Adjustment and Performance Comparison.

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Wholey, Douglas R; Finch, Michael; Kreiger, Rob; Reeves, David

2018-01-03

Performance measurement and public reporting are increasingly being used to compare clinic performance. Intended consequences include quality improvement, value-based payment, and consumer choice. Unintended consequences include reducing access for riskier patients and inappropriately labeling some clinics as poor performers, resulting in tampering with stable care processes. Two analytic steps are used to maximize intended and minimize unintended consequences. First, risk adjustment is used to reduce the impact of factors outside providers' control. Second, performance categorization is used to compare clinic performance using risk-adjusted measures. This paper examines the effects of methodological choices, such as risk adjusting for sociodemographic factors in risk adjustment and accounting for patients clustering by clinics in performance categorization, on clinic performance comparison for diabetes care, vascular care, asthma, and colorectal cancer screening. The population includes all patients with commercial and public insurance served by clinics in Minnesota. Although risk adjusting for sociodemographic factors has a significant effect on quality, it does not explain much of the variation in quality. In contrast, taking into account the nesting of patients within clinics in performance categorization has a substantial effect on performance comparison.

Interventions to Increase Male Attendance and Testing for Sexually Transmitted Infections at Publicly-Funded Family Planning Clinics.

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Fine, David; Warner, Lee; Salomon, Sarah; Johnson, David M

2017-07-01

We assessed the impact of staff, clinic, and community interventions on male and female family planning client visit volume and sexually transmitted infection testing at a multisite community-based health care agency. Staff training, clinic environmental changes, in-reach/outreach, and efficiency assessments were implemented in two Family Health Center (San Diego, CA) family planning clinics during 2010-2012; five Family Health Center family planning programs were identified as comparison clinics. Client visit records were compared between preintervention (2007-2009) and postintervention (2010-2012) for both sets of clinics. Of 7,826 male client visits during the time before intervention, most were for clients who were aged male visits (4,004 to 8,385; Δ = +109%); for comparison clinics, male visits increased modestly (3,822 to 4,500; Δ = +18%). The proportion of male clinic visits where chlamydia testing was performed increased in intervention clinics (35% to 42%; p males yielded similar findings for male client volume and chlamydia testing. The number of female visits declined nearly 40% in both comparison (21,800 to 13,202; -39%) and intervention clinics (30,830 to 19,971; -35%) between preintervention and postintervention periods. Multilevel interventions designed to increase male client volume and sexually transmitted infection testing services in family planning clinics succeeded without affecting female client volume or services. Copyright © 2017 Society for Adolescent Health and Medicine. All rights reserved.

Can the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) be used to accurately report clinic total reproductive potential (TRP)?

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Stern, Judy E; Hickman, Timothy N; Kinzer, Donna; Penzias, Alan S; Ball, G David; Gibbons, William E

2012-04-01

To assess whether total reproductive potential (TRP), the chance of a live birth from each fresh cycle (fresh cycle plus frozen transfers), could be calculated from the national Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) database and whether information not available in SART CORS resulted in significant changes to the TRP calculation. Retrospective study using SART CORS and clinic data. Three assisted reproductive technology clinics. Women undergoing ART. None. Two- and three-year TRPs for 2005 and 2006 were calculated according to patient age at cycle start by linking fresh to frozen cycles up to first live birth. Clinic records were used to adjust for (remove) frozen cycles that used more than one fresh cycle as a source of embryos and for any embryos donated to other patients or research or shipped to another facility before a live birth. TRP was higher than fresh per-cycle rates for most ages at all clinics, although accuracy was compromised when there were fewer than 20 cycles per category. Two- and 3-year TRPs differed in only 2 of 24 calculations. Adjusted TRPs differed less than three percentage points from unadjusted TRPs when volume was sufficient. Clinic TRP can be calculated from SART CORS. Data suggest that calculations of clinic TRP from the national dataset would be meaningful. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

A low-cost ultrasound program leads to increased antenatal clinic visits and attended deliveries at a health care clinic in rural Uganda.

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Andrew B Ross

Full Text Available BACKGROUND: In June of 2010, an antenatal ultrasound program to perform basic screening for high-risk pregnancies was introduced at a community health care center in rural Uganda. Whether the addition of ultrasound scanning to antenatal visits at the health center would encourage or discourage potential patients was unknown. Our study sought to evaluate trends in the numbers of antenatal visits and deliveries at the clinic, pre- and post-introduction of antenatal ultrasound to determine what effect the presence of ultrasound at the clinic had on these metrics. METHODS AND FINDINGS: Records at Nawanyago clinic were reviewed to obtain the number of antenatal visits and deliveries for the 42 months preceding the introduction of ultrasound and the 23 months following. The monthly mean deliveries and antenatal visits by category (first visit through fourth return visit were compared pre- and post- ultrasound using a Kruskal-Wallis one-way ANOVA. Following the introduction of ultrasound, significant increases were seen in the number of mean monthly deliveries and antenatal visits. The mean number of monthly deliveries at the clinic increased by 17.0 (13.3-20.6, 95% CI from a pre-ultrasound average of 28.4 to a post-ultrasound monthly average of 45.4. The number of deliveries at a comparison clinic remained flat over this same time period. The monthly mean number of antenatal visits increased by 97.4 (83.3-111.5, 95% CI from a baseline monthly average of 133.5 to a post-ultrasound monthly mean of 231.0, with increases seen in all categories of antenatal visits. CONCLUSIONS: The availability of a low-cost antenatal ultrasound program may assist progress towards Millennium Development Goal 5 by encouraging women in a rural environment to come to a health care facility for skilled antenatal care and delivery assistance instead of utilizing more traditional methods.

Pathological and Clinical Correlation between Celiac Disease and Helicobacter Pylori Infection; a Review of Controversial Reports.

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Rostami-Nejad, Mohammad; Javad Ehsani-Ardakani, Mohammad; Assadzadeh, Hamid; Shahbazkhani, Bijan; Ierardi, Enzo; Losurdo, Giuseppe; Zojaji, Homayon; Alizadeh, Amirhoshang Mohammad; Naderi, Nosratollah; Sadeghi, Amir; Zali, Mohammad Reza

2016-04-01

There are overwhelming reports and descriptions about celiac associated disorders. Although there is a clear genetic association between celiac disease (CD) and some gastrointestinal disorders, there are controversial reports claiming an association between CD and Helicobacter pylori (H. pylori) infection. Different studies indicated the possible association between lymphocytic gastritis and both CD and H. pylori infection, although this evidence is not consistently accepted. Also it was shown that an increase in intraepithelial lymphocytes count is associated with both H. pylori infection and celiac disease. Therefore the following questions may raise: how far is this infection actually related to CD?, which are the underlying patho-mechanisms for these associations? what are the clinical implications? what is the management? and what would be the role of gluten free diet in treating these conditions? PubMed (PubMed Central), Ovid, ISI of web knowledge, and Google scholar were searched for full text articles published between 1985 and 2015. The associated keywords were used, and papers described particularly the impact of pathological and clinical correlation between CD and H. pylori infection were identified. In this review we tried to answer the above questions and discussed some of the recent developments in the pathological and clinical aspects of CD and H. pylori infection.

Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice.

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Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob

2015-09-01

Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.

The reliability of manual reporting of clinical events in an anesthesia information management system (AIMS).

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Simpao, Allan F; Pruitt, Eric Y; Cook-Sather, Scott D; Gurnaney, Harshad G; Rehman, Mohamed A

2012-12-01

Manual incident reports significantly under-report adverse clinical events when compared with automated recordings of intraoperative data. Our goal was to determine the reliability of AIMS and CQI reports of adverse clinical events that had been witnessed and recorded by research assistants. The AIMS and CQI records of 995 patients aged 2-12 years were analyzed to determine if anesthesia providers had properly documented the emesis events that were observed and recorded by research assistants who were present in the operating room at the time of induction. Research assistants recorded eight cases of emesis during induction that were confirmed with the attending anesthesiologist at the time of induction. AIMS yielded a sensitivity of 38 % (95 % confidence interval [CI] 8.5-75.5 %), while the sensitivity of CQI reporting was 13 % (95 % CI 0.3-52.7 %). The low sensitivities of the AIMS and CQI reports suggest that user-reported AIMS and CQI data do not reliably include significant clinical events.

Impaired Physical Performance and Clinical Responses after a Recreational Bodybuilder's Self-Administration of Steroids: A Case Report

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Veras, Katherine; Silva-Junior, Fernando Lopes; Lima-Silva, Adriano Eduardo; De-Oliveira, Fernando Roberto

2015-01-01

We reported clinical and physical responses to 7 weeks of anabolic-androgenic steroid (AAS) self-administration in a male recreational bodybuilder. He was self-administrating a total of 3,250 mg of testosterone when his previous and current clinical and physical trials records were revisited. Body shape, performance, and biochemistry results were clustered into three phases labeled PRE (before the self-use), POST I (immediately at the cessation of the 7-week administration), and POST II (12 weeks after the cessation). Elevated testosterone and estradiol levels were observed in the POST I phase, while hepatic and renal functions remained altered in the POST II phase. Body mass and body fat percentages increased throughout the three phases. When adjusted according to body mass, drops in aerobic and anaerobic power and capacity (2.1% to 12.9%) were observed across the phases. This case report shows that overall performance decreased when a bodybuilding practitioner self-administered AAS. PMID:26770942

Race/Ethnicity and the Pharmacogenetics of Reported Suicidality With Efavirenz Among Clinical Trials Participants.

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Mollan, Katie R; Tierney, Camlin; Hellwege, Jacklyn N; Eron, Joseph J; Hudgens, Michael G; Gulick, Roy M; Haubrich, Richard; Sax, Paul E; Campbell, Thomas B; Daar, Eric S; Robertson, Kevin R; Ventura, Diana; Ma, Qing; Edwards, Digna R Velez; Haas, David W

2017-09-01

We examined associations between suicidality and genotypes that predict plasma efavirenz exposure among AIDS Clinical Trials Group study participants in the United States. Four clinical trials randomly assigned treatment-naive participants to efavirenz-containing regimens; suicidality was defined as reported suicidal ideation or attempted or completed suicide. Genotypes that predict plasma efavirenz exposure were defined by CYP2B6 and CYP2A6 polymorphisms. Associations were evaluated with weighted Cox proportional hazards models stratified by race/ethnicity. Additional analyses adjusted for genetic ancestry and selected covariates. Among 1833 participants, suicidality was documented in 41 in exposed analyses, and 34 in on-treatment analyses. In unadjusted analyses based on 12 genotype levels, suicidality increased per level in exposed (hazard ratio, 1.11; 95% confidence interval, .96-1.27) and on-treatment 1.16; 1.01-1.34) analyses. In the on-treatment analysis, the association was strongest among white but nearly null among black participants. Considering 3 metabolizer levels (extensive, intermediate and slow), slow metabolizers were at increased risk. Results were similar after baseline covariate-adjustment for genetic ancestry, sex, age, weight, injection drug use history, and psychiatric history or recent psychoactive medication. Genotypes that predict higher plasma efavirenz exposure were associated with increased risk of suicidality. Strength of association varied by race/ethnicity. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Increasing clinical, satisfaction, and financial performance through nurse-driven process improvement.

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Sims, Caroline E

2003-02-01

Providers and regulatory agencies are increasing their demands for hospitals to document clinical quality and customer satisfaction at a decreased cost. Nurse leaders search for ways to meet these requirements while retaining their most valuable resource: healthcare workers (especially nurses). First-line leadership struggles with balancing quality, cost-effectiveness, and staff retention. The author discusses the planning, methodology, implementation, and outcomes of a staff driven process improvement initiative.

The Resident-Run Minor Surgery Clinic: A Pilot Study to Safely Increase Operative Autonomy.

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Wojcik, Brandon M; Fong, Zhi Ven; Patel, Madhukar S; Chang, David C; Petrusa, Emil; Mullen, John T; Phitayakorn, Roy

General surgery training has evolved to align with changes in work hour restrictions, supervision regulations, and reimbursement practices. This has culminated in a lack of operative autonomy, leaving residents feeling inadequately prepared to perform surgery independently when beginning fellowship or practice. A resident-run minor surgery clinic increases junior resident autonomy, but its effects on patient outcomes have not been formally established. This pilot study evaluated the safety of implementing a resident-run minor surgery clinic within a university-based general surgery training program. Single institution case-control pilot study of a resident-run minor surgery clinic from 9/2014 to 6/2015. Rotating third-year residents staffed the clinic once weekly. Residents performed operations independently in their own procedure room. A supervising attending surgeon staffed each case prior to residents performing the procedure and viewed the surgical site before wound closure. Postprocedure patient complications and admissions to the hospital because of a complication were analyzed and compared with an attending control cohort. Massachusetts General Hospital General in Boston, MA; an academic tertiary care general surgery residency program. Ten third-year general surgery residents. Overall, 341 patients underwent a total of 399 procedures (110 in the resident clinic vs. 289 in the attending clinic). Minor surgeries included soft tissue mass excision (n = 275), abscess incision and drainage (n = 66), skin lesion excision (n = 37), skin tag removal (n = 15), and lymph node excision (n = 6). There was no significant difference in the overall rate of patients developing a postprocedure complication within 30 days (3.6% resident vs. 2.8% attending; p = 0.65); which persisted on multivariate analysis. Similar findings were observed for the rate of hospital admission resulting from a complication. Resident evaluations overwhelmingly supported the rotation, citing

Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

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Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

2010-01-01

This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review

DEFF Research Database (Denmark)

Campana, LG; Clover, AJ; Valpione, S

2016-01-01

Electrochemotherapy is becoming a well-established treatment for malignancies of skin and non-skin origin and its use is widening across Europe. The technique was developed and optimized from solid experimental and clinical evidence. A consensus document is now warranted to formalize reporting re...... studies and to provide the recommendations for reporting clinical trials on electrochemotherapy....... results, which should strengthen evidence-based practice recommendations. This consensus should be derived from high quality clinical data collection, clinical expertise and summarizing patient feedback. The first step, which is addressed in this paper, aims to critically analyze the quality of published...

Alzheimer biomarkers and clinical Alzheimer disease were not associated with increased cerebrovascular disease in a memory clinic population.

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Spies, Petra E; Verbeek, Marcel M; Sjogren, Magnus J C; de Leeuw, Frank-Erik; Claassen, Jurgen A H R

2014-01-01

Preclinical and post-mortem studies suggest that Alzheimer disease (AD) causes cerebrovascular dysfunction, and therefore may enhance susceptibility to cerebrovascular disease (CVD). The objective of this study was to investigate this association in a memory clinic population. The AD biomarkers CSF amyloid β42, amyloid β40 and APOE-ε4 status have all been linked to increased CVD risk in AD, and therefore the first aim of this study was to analyze the association between these biomarkers and CVD. In 92 memory clinic patients the cross-sectional association between AD biomarkersand the severity of CVD was investigated with linear regression analysis. Additionally, we studied whether AD biomarkers modified the relation between vascular risk factors and CVD. CVD was assessed on MRI through a visual rating scale.Analyses were adjusted for age. The second aim of this study was to investigate the association between clinical AD and CVD, where 'clinical AD' was defined as follows: impairment in episodic memory, hippocampal atrophy and an aberrant concentration of cerebrospinal fluid (CSF) biomarkers. 47 of the 92 patients had AD. No association between CSF amyloid β42, amyloid β40 or APOE-ε4 status and CVD severity was found, nor did these AD biomarkers modify the relation between vascular risk factors and CVD. Clinical AD was not associated with CVD severity (p=0.83). Patients with more vascular risk factors had more CVD, but this relationship was not convincingly modified by AD (p=0.06). In this memory clinic population, CVD in patients with AD was related to vascular risk factors and age, comparable to patients without AD. Therefore, in our study, the preclinical and post-mortem evidence that AD would predispose to CVD could not be translated clinically. Further work, including replication of this work in a different and larger sample, is warranted.

The clinical factors′ prediction of increased intradialytic qt dispersion on the electrocardiograms of chronic hemodialysis patients

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Dina Oktavia

2013-01-01

Full Text Available Ventricular arrhythmias and sudden death are common in patients on maintenance hemodialysis (HD. The increase in QT dispersion (QTd on the electrocardiogram (ECG reflects increased tendency for ventricular repolarization that predisposes to arrhythmias. The purpose of the study was to identify the clinical factors that may predict the increased intradialytic QTd and to assess differences in QTd before and after HD. Each of 61 chronic HD patients underwent 12-lead ECG and blood pressure (BP measurement before and every 1 h during a single HD session. The QT intervals were corrected for heart rate using Bazett′s formula. Intradialytic QTd increased in 30 (49% patients. There was no correlation between the increased QTd and the clinical factors including hypertension, pulse pressure, intradialytic hypotension, left ventricular hypertrophy, old myocardial infarct, diabetes mellitus, and nutritional status. The means of QT interval and QTd increased after HD session (from 382 ± 29 to 444 ± 26 ms, P <0.05; and from 74 ± 21 to 114 ± 53 ms, respectively, P <0.05. We conclude that the increased intradialytic QTd could not be predicted by any of the clinical factors evaluated in this study. There was significant difference in the means of QTd before and after HD session.

Simple clinical means of documenting increased pulmonary endothelial permeability to protein

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Mishkin, F.S.; Niden, A.; Kumar, A.; Thomas, A.; Reese, I.C.; Vasinrapee, P.

1987-02-20

The authors investigated a simple method that can be used at the bedside for documenting the net accumulation of albumin in the lung. The technique employs measurement with a computer-linked gamma camera of the activity ratio in an area of the right lung compared with the same-sized area in the heart at 20 minutes and three hours following intravenous injection of technetium Tc 99m albumin. They applied this measurement to three groups of patients: a control group and patients with roentgenographic evidence of edema classified according to clinically available criteria as either hydrostatic edema or permeability edema to see if they could document differences among these groups. In control patients this ratio did not increase by more than seven units between the 20-minute and three-hour measurements. Of 18 patients classified by other routine clinical means as having hydrostatic pulmonary edema, 89% showed no increase in lung albumin accumulation. In 29 patients with permeability edema associated with the so-called adult respiratory distress syndrome, 31% showed evidence of net pulmonary albumin accumulation. These findings suggest that some patients otherwise classified as having hydrostatic edema have concomitant permeability changes in the microvasculature and that permeability edema represents a spectrum of endothelial damage.

Simple clinical means of documenting increased pulmonary endothelial permeability to protein

International Nuclear Information System (INIS)

Mishkin, F.S.; Niden, A.; Kumar, A.; Thomas, A.; Reese, I.C.; Vasinrapee, P.

1987-01-01

The authors investigated a simple method that can be used at the bedside for documenting the net accumulation of albumin in the lung. The technique employs measurement with a computer-linked gamma camera of the activity ratio in an area of the right lung compared with the same-sized area in the heart at 20 minutes and three hours following intravenous injection of technetium Tc 99m albumin. They applied this measurement to three groups of patients: a control group and patients with roentgenographic evidence of edema classified according to clinically available criteria as either hydrostatic edema or permeability edema to see if they could document differences among these groups. In control patients this ratio did not increase by more than seven units between the 20-minute and three-hour measurements. Of 18 patients classified by other routine clinical means as having hydrostatic pulmonary edema, 89% showed no increase in lung albumin accumulation. In 29 patients with permeability edema associated with the so-called adult respiratory distress syndrome, 31% showed evidence of net pulmonary albumin accumulation. These findings suggest that some patients otherwise classified as having hydrostatic edema have concomitant permeability changes in the microvasculature and that permeability edema represents a spectrum of endothelial damage

Telehealth clinics increase access to care for adults with cystic fibrosis living in rural and remote Western Australia.

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Wood, Jamie; Mulrennan, Siobhain; Hill, Kylie; Cecins, Nola; Morey, Sue; Jenkins, Sue

2017-08-01

Introduction A significant proportion (15%, n = 28) of the adults with cystic fibrosis (CF) in Western Australia (WA) live in rural and remote areas and have difficulty accessing specialist care at the state adult CF centre, located in Perth. We aimed to increase access by offering telehealth clinics, and evaluate the impact on health outcomes. Methods Telehealth clinics were offered via videoconference over a 12-month period, with uptake and satisfaction measured at the end of the intervention. Participants could still attend in person clinics at the CF centre if requested. Other outcomes comprised healthcare utilisation (HCU), spirometry, weight and health-related quality of life. Results In 21 participants, total clinic visits increased from 46 (median (range) per participant 2 (0-6)) in the 12-month period preceding the study to 100 (5 (2-8), p vitality domain of the Cystic Fibrosis Questionnaire - Revised ( p < 0.05). Discussion Telehealth had good uptake and increased clinic attendance in adults with CF living in rural and remote WA, and had high satisfaction amongst participants. The increase in HCU, resulting from increased detection and treatment of exacerbations, may improve long-term outcomes in this population.

International, multi-center standardization of acute graft-versus-host disease clinical data collection: a report from the MAGIC consortium

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Harris, Andrew C.; Young, Rachel; Devine, Steven; Hogan, William J.; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A.; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S.; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L.M.; Levine, John E.

2015-01-01

Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and non-relapse mortality following allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed upon by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multi-center clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance was following discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture which may improve the reproducibility of GVHD clinical trials after further prospective validation. PMID:26386318

Seasonal and socio-economic variations in clinical and self-reported ...

African Journals Online (AJOL)

Seasonal and socio-economic variations in clinical and self-reported malaria in Accra, Ghana: Evidence from facility data and a community survey. ... Conclusions: Understanding these seasonal and geographic patterns have implications for both prevention and treatment of malaria-like morbidity in both children and adults ...

Restoration-Guided Implant Rehabilitation of the Complex Partial Edentulism: a Clinical Report

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Nikitas Sykaras

2010-01-01

Full Text Available Background: The hard and soft tissue deficiency is a limiting factor for the prosthetic restoration and any surgical attempt to correct the anatomic foundation needs to be precisely executed for optimal results. The purpose of this paper is to describe the clinical steps that are needed to confirm the treatment plan and allow its proper execution.Methods: Team work and basic principles are emphasized in a step-by-step description of clinical methods and techniques. This clinical report describes the interdisciplinary approach in the rehabilitation of a partially edentulous patient. The importance of the transitional restoration which sets the guidelines for the proper execution of the treatment plan is especially emphasized along with all the steps that have to be followed.Results: The clinical report describes the diagnostic arrangement of teeth, the ridge augmentation based on the diagnostic evaluation of the removable prosthesis, the implant placement with a surgical guide in the form of the removable partial denture duplicate and finally the special 2-piece design of the final fixed prosthesis.Conclusions: Clinical approach and prosthesis design described above offers a predictable way to restore partial edentulism with a fixed yet retrievable prosthesis, restoring soft tissue and teeth and avoiding an implant supported overdenture.

Retailing research: increasing the role of evidence in clinical services for childbirth.

Science.gov (United States)

Lomas, J

1993-01-01

A current review of the structures and assumptions of research transfer for clinical care reveals some progress from "passive diffusion" to "active dissemination" models, but little or no progress has been made toward targeting local influences on practitioner behavior for "coordinated implementation" of clinically relevant research into childbirth (or other) medical practices. The implementation of scientifically valid research syntheses, such as Effective Care in Pregnancy and Childbirth (ECPC), is therefore constrained by a poorly developed marketplace for retailing research information to practitioners. A survey in Canada of the four most significant potential retailing groups demonstrated that whereas clinical and community groups were adopting the necessary knowledge and attitudes, public policy makers and administrators trailed well behind them. To increase the probability of thorough retailing of ECPC, a three-phase plan could be instituted that would identify product champions within potential retailing groups, develop implementation activities for each retailing group, and convene annual conferences.

Updated clinical guidelines experience major reporting limitations

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Robin W.M. Vernooij

2017-10-01

Full Text Available Abstract Background The Checklist for the Reporting of Updated Guidelines (CheckUp was recently developed. However, so far, no systematic assessment of the reporting of updated clinical guidelines (CGs exists. We aimed to examine (1 the completeness of reporting the updating process in CGs and (2 the inter-observer reliability of CheckUp. Methods We conducted a systematic assessment of the reporting of the updating process in a sample of updated CGs using CheckUp. We performed a systematic search to identify updated CGs published in 2015, developed by a professional society, reporting a systematic review of the evidence, and containing at least one recommendation. Three reviewers independently assessed the CGs with CheckUp (16 items. We calculated the median score per item, per domain, and overall, converting scores to a 10-point scale. Multiple linear regression analyses were used to identify differences according to country, type of organisation, scope, and health topic of updated CGs. We calculated the intraclass coefficient (ICC and 95% confidence interval (95% CI for domains and overall score. Results We included in total 60 updated CGs. The median domain score on a 10-point scale for presentation was 5.8 (range 1.7 to 10, for editorial independence 8.3 (range 3.3 to 10, and for methodology 5.7 (range 0 to 10. The median overall score on a 10-point scale was 6.3 (range 3.1 to 10. Presentation and justification items at recommendation level (respectively reported by 27 and 38% of the CGs and the methods used for the external review and implementing changes in practice were particularly poorly reported (both reported by 38% of the CGs. CGs developed by a European or international institution obtained a statistically significant higher overall score compared to North American or Asian institutions (p = 0.014. Finally, the agreement among the reviewers on the overall score was excellent (ICC 0.88, 95% CI 0.75 to 0.95. Conclusions The

Self-reported hand hygiene perceptions and barriers among companion animal veterinary clinic personnel in Ontario, Canada

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Anderson, Maureen E.C.; Weese, J. Scott

2016-01-01

The objective of this study was to describe the perceived importance of and barriers to hand hygiene among companion animal clinic staff. An anonymous, voluntary written questionnaire was completed by 356 of approximately 578 individuals (62%) from 49/51 clinics. On a scale of 1 (not important) to 7 (very important), the percentage of respondents who rated hand hygiene as a 5 or higher was at least 82% in all clinical scenarios queried. The most frequently reported reason for not performing hand hygiene was forgetting to do so (40%, 141/353). Specific discussion of hand hygiene practices at work was recalled by 32% (114/354) of respondents. Although veterinary staff seem to recognize the importance of hand hygiene, it should be emphasized more during staff training. Other barriers including time constraints and skin irritation should also be addressed, possibly through increased access to and use of alcohol-based hand sanitizers. PMID:26933265

Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity

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Marleen E. Jansen

2017-08-01

Full Text Available Advances from pharmacogenetics (PGx have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.

Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency.

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Hamilton, Samina; Bernstein, Aaron B; Blakey, Graham; Fagan, Vivien; Farrow, Tracy; Jordan, Debbie; Seiler, Walther; Shannon, Anna; Gertel, Art

2016-01-01

Interventional clinical studies conducted in the regulated drug research environment are reported using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E3 on the structure and content of clinical study reports (CSRs) published in 1995 and ICH E3 supplementary Questions & Answers (Q & A) published in 2012.Since the ICH guidance documents were published, there has been heightened awareness of the importance of disclosure of clinical study results. The use of the CSR as a key source document to fulfil emerging obligations has resulted in a re-examination of how ICH guidelines are applied in CSR preparation. The dynamic regulatory and modern drug development environments create emerging reporting challenges. Regulatory medical writing and statistical professionals developed Clarity and Openness in Reporting: E3-based (CORE) Reference over a 2-year period. Stakeholders contributing expertise included a global industry association, regulatory agency, patient advocate, academic and Principal Investigator representatives. CORE Reference should help authors navigate relevant guidelines as they create CSR content relevant for today's studies. It offers practical suggestions for developing CSRs that will require minimum redaction and modification prior to public disclosure.CORE Reference comprises a Preface, followed by the actual resource. The Preface clarifies intended use and underlying principles that inform resource utility. The Preface lists references contributing to development of the resource, which broadly fall into 'regulatory' and 'public disclosure' categories. The resource includes ICH E3 guidance text, ICH E3 Q & A 2012-derived guidance text and CORE Reference text, distinguished from one another through the use of shading. Rationale comments are used throughout for clarification purposes.A separate mapping tool comparing ICH E3 sectional structure and CORE Reference sectional structure is also provided.Together, CORE Reference

Guide to enable health charities to increase recruitment to clinical trials on dementia.

Science.gov (United States)

Chambers, Larry W; Harris, Megan; Lusk, Elizabeth; Benczkowski, Debbie

2017-11-01

The Alzheimer Society embarked on a project to improve ways that the 60 provincial and local Societies in Canada can work with local researchers to support recruitment of volunteers to clinical trials and studies. A Guide to assist these offices was produced to design ethical recruitment of research volunteers within their client populations. Consultations with individuals from provincial and local Societies, as well as researchers and leaders from health-related organizations, were conducted to identify in what ways these organizations are involved in study volunteer recruitment, what is and is not working, and what would be helpful to support future efforts. The Guide prototype used scenarios to illustrate study volunteer recruitment practices as they have been or could be applied in Societies. An implementable version of the Guide was produced with input from multiple internal and external reviewers including subject-matter experts and target users from Societies. Society staff reported that benefits of using the Guide were that it served as a catalyst for conversation and reflection and identified the need for a policy. Also, it enabled Society readiness to respond to requests by persons with dementia and their caregivers wishing to participate in research. A majority (94%) of participating Society staff across Canada agreed that they would increase their capacity to support research recruitment. Charitable organizations that raise funds for research have a role in promoting the recruitment of persons with dementia and their caregivers into clinical trials and studies. The Guide was produced to facilitate organizational change to both create a positive culture regarding research as well as practical solutions that can help organizations achieve this goal.

A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program).

Science.gov (United States)

Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S

2014-12-01

A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.

Increased detection of co-morbidities with evaluation at a dedicated adult Turner syndrome clinic.

Science.gov (United States)

Vincent, A J; Nguyen, H H; Ranasinha, S; Vollenhoven, B

2017-10-01

Turner syndrome (TS), resulting from complete/partial X chromosomal monosomy, is associated with multiple co-morbidities and increased mortality. Although multidisciplinary management is recommended, TS women's health care is sub-optimal. This study evaluates a multidisciplinary adult TS service. Retrospective cohort study of 82 patients attending the quarterly TS clinic from December 2003 to December 2014. Evaluation included (1) demographics, (2) TS standardized co-morbidity screening, and (3) estrogen therapy use. Data analysis involved frequency statistics, T tests and polychoric correlation analysis. Median age at TS diagnosis was 14 years (range 0-65 years), with 12% of women aged >18 years. Median age at initial consultation was 31 years (range 16-65 years). Only 14% of patients were transition program referrals. XO karyotype occurred in 30%. Primary amenorrhea predominated; however, 37% of TS women were not taking estrogen therapy. The proportion of patients not previously screened (44-76%) and those with positive screening diagnoses (5-53%) varied according to co-morbidity. The mean (± standard deviation) number of co-morbidities identified increased following TS clinic screening (7.0 ± 2.6 post-screening vs. 4.4 ± 2.3 pre-screening; p < 0.0001). Polychoric correlation analysis identified particular co-morbidity groupings (including metabolism-related) and increased co-morbidities with primary amenorrhea. A multidisciplinary adult TS clinic improves health surveillance with increased identification of co-morbidities and initiation of estrogen therapy.

Traumatic Maculopathy 6 Months after Injury: A Clinical Case Report

Directory of Open Access Journals (Sweden)

Sílvia Mendes

2014-03-01

Full Text Available Purpose: This study aims to report a case of traumatic maculopathy in a 12-year-old male following blunt trauma in his left eye (LE who presented 6 months after injury. Methods: Retrospective and descriptive case report based on data from clinical records, patient observation and analysis of diagnostic tests. Results: A previously healthy, 12-year-old male presented for a routine visit with complaints of a 2-month history of decreased visual acuity in his LE. Six months before the initial visit, he suffered blunt trauma to the LE during a struggle and had no medical observation. At the visit, best-corrected visual acuity (BCVA in the LE was counting fingers and in the right eye, it was 20/20. Fundus examination of the LE showed a central macular lesion of 1 disc diameter with fibrosis, increased retinal thickness and intraretinal hemorrhage. Optical coherence tomography showed disruption of the inner/outer segment (IS/OS photoreceptor junction, increased reflectivity, cell infiltration of the retinal wall and retinal pigment epithelium detachment. Retinal thickness was 289 μm at the site of the lesion. A fluorescein angiogram revealed early impregnation and late diffusion. High-dose steroid pulse therapy (intravenous methylprednisolone 500 mg for 3 days and oral prednisolone 30 mg, tapering for 10 days was done. LE BCVA increased to 20/200, and retinal thickness decreased by 71 μm 1 week after treatment. Off-label intravitreal triamcinolone (IVTA; 0.05 ml/2 mg was administered 2 weeks after oral treatment in an attempt to achieve additional improvement. Three weeks after IVTA, LE BCVA improved to 20/150 and retinal thickness decreased by 10 μm. Three months after the initial visit, LE BCVA was 20/125 and retinal thickness 208 μm. Conclusion: We present a case of commotio retinae caused by an ocular blunt trauma 6 months before, with loss of BCVA. BCVA improved after oral steroids and IVTA. Nevertheless, fibrosis and disruption of the IS

Mortality risk in hemodialysis patients with increased arterial stiffness is reduced by attainment of classical clinical performance measures

DEFF Research Database (Denmark)

Scholze, Alexandra; Thies, Christina; Cheikhalfraj, Mohamed

2009-01-01

We determined whether attainment of classical clinical performance measures for hemodialysis care improves survival in hemodialysis patients with increased arterial stiffness.......We determined whether attainment of classical clinical performance measures for hemodialysis care improves survival in hemodialysis patients with increased arterial stiffness....

Self- and rater-assessed effectiveness of "thinking-aloud" and "regular" morning report to intensify young physicians' clinical skills.

Science.gov (United States)

Hsu, Hui-Chi; Lee, Fa-Yauh; Yang, Ying-Ying; Tsao, Yen-Po; Lee, Wen-Shin; Chuang, Chiao-Lin; Chang, Ching-Chih; Huang, Chia-Chang; Huang, Chin-Chou; Ho, Shung-Tai

2015-09-01

This study compared the effects of the "thinking aloud" (TA) morning report (MR), which is characterized by sequential and interactive case discussion by all participants, with "regular" MR for clinical skill training of young physicians. Between February 2011 and February 2014, young physicians [including postgraduate year-1 (PGY1) residents, interns, and clerks) from our hospital were sequentially enrolled and followed for 3 months. The self- and rater-assessed educational values of two MR models for building up clinical skills of young physicians were compared. The junior (intern and clerk) attendees had higher self-assessed educational values scores and reported post-training application frequency of skills trained by TA MR compared with the senior (PGY1 resident) attendees. Higher average and percentage of increased overall rater-assessed OSCE scores were noted among the regular MR senior attendees and TA MR junior attendees than in their corresponding control groups (regular MR junior attendees and TA MR senior attendees). Interestingly, regular MRs provided additional beneficial effects for establishing the "professionalism, consulting skills and organization efficiency" aspects of clinical skills of senior/junior attendees. Moreover, senior and junior attendees benefited the most by participating in seven sessions of regular MR and TA MR each month, respectively. TA MR effectively trains junior attendees in basic clinical skills, whereas regular MR enhances senior attendees' "work reports, professionalism, organizational efficiency, skills in dealing with controversial and professional issues." Undoubtedly, all elements of the two MR models should be integrated together to ensure patient safety and good discipline among young physicians. Copyright © 2015. Published by Elsevier Taiwan.

Rehabilitation and multiple limb amputations: A clinical report of patients injured in combat.

Science.gov (United States)

Melcer, Ted; Pyo, Jay; Walker, Jay; Quinn, Kimberly; Lebedda, Martin; Neises, Kamaran; Nguyen, Christina; Galarneau, Michael

2016-01-01

This clinical report describes the outpatient rehabilitation program for patients with multiple limb amputations enrolled in the Comprehensive Combat and Complex Casualty Care facility at the Naval Medical Center San Diego. Injury-specific data for 29 of these patients wounded by blast weaponry in Afghanistan in 2010 or 2011 were captured by the Expeditionary Medical Encounter Database at the Naval Health Research Center and were reviewed for this report. Their median Injury Severity Score was 27 (N = 29; range, 11-54). Patients averaged seven moderate to serious injuries (Abbreviated Injury Scale scores ≥2), including multiple injuries to lower limbs and injuries to the torso and/or upper limbs. All patients received care from numerous clinics, particularly physical therapy during the first 6 mo postinjury. Clinic use generally declined after the first 6 mo with the exception of prosthetic devices and repairs. The clinical team implemented the Mayo-Portland Adaptability Inventory, 4th Revision (MPAI-4) to assess functioning at outpatient program initiation and discharge (n = 23). At program discharge, most patients had improved scores for the MPAI-4 items assessing mobility, pain, and transportation, but not employment. Case reports described rehabilitation for two patients with triple amputations and illustrated multispecialty care and contrasting solutions for limb prostheses.

Prosthetic rehabilitation of a patient after partial maxillectomy: A clinical report

OpenAIRE

Rodrigues, Shobha J.; Saldanha, Sharon

2011-01-01

Malignant melanoma of the oral cavity is very rare. This clinical report describes a method for prosthetic rehabilitation of a patient with malignant melanoma of the palate following partial maxillectomy with a closed hollow interim obturator.

Clinical neuropharmacology of drugs of abuse: a comparison of drug-discrimination and subject-report measures.

Science.gov (United States)

Kelly, Thomas H; Stoops, William W; Perry, Andrea S; Prendergast, Mark A; Rush, Craig R

2003-12-01

Advances in molecular pharmacology and behavioral science have helped elucidate the structure and function of the central nervous system and its relationship to behavior and has sparked the development of pharmacological agents that have increasingly selective and potent effects with fewer adverse side effects. The sensitivity and predictive validity of the two most commonly used methodologies for assessing the neuropharmacological effects of centrally active drugs, subject report of drug effects and drug discrimination, were examined. The sensitivity of the measures was comparable across stimulant, sedative, and opioid drugs. Results with drug-discrimination methodologies were generally consistent with hypothesized neuropharmacological mechanisms across all drug classes, whereas subject reports conformed under more limited testing conditions. Firm conclusions regarding the relative utility of drug-discrimination and subject-report measures for clinical studies of neuropharmacological mechanisms are limited by the small number of studies in which the two methodologies have been tested using identical pharmacological pretreatment manipulations.

Self-Reported and Observed Punitive Parenting Prospectively Predicts Increased Error-Related Brain Activity in Six-Year-Old Children.

Science.gov (United States)

Meyer, Alexandria; Proudfit, Greg Hajcak; Bufferd, Sara J; Kujawa, Autumn J; Laptook, Rebecca S; Torpey, Dana C; Klein, Daniel N

2015-07-01

The error-related negativity (ERN) is a negative deflection in the event-related potential (ERP) occurring approximately 50 ms after error commission at fronto-central electrode sites and is thought to reflect the activation of a generic error monitoring system. Several studies have reported an increased ERN in clinically anxious children, and suggest that anxious children are more sensitive to error commission--although the mechanisms underlying this association are not clear. We have previously found that punishing errors results in a larger ERN, an effect that persists after punishment ends. It is possible that learning-related experiences that impact sensitivity to errors may lead to an increased ERN. In particular, punitive parenting might sensitize children to errors and increase their ERN. We tested this possibility in the current study by prospectively examining the relationship between parenting style during early childhood and children's ERN approximately 3 years later. Initially, 295 parents and children (approximately 3 years old) participated in a structured observational measure of parenting behavior, and parents completed a self-report measure of parenting style. At a follow-up assessment approximately 3 years later, the ERN was elicited during a Go/No-Go task, and diagnostic interviews were completed with parents to assess child psychopathology. Results suggested that both observational measures of hostile parenting and self-report measures of authoritarian parenting style uniquely predicted a larger ERN in children 3 years later. We previously reported that children in this sample with anxiety disorders were characterized by an increased ERN. A mediation analysis indicated that ERN magnitude mediated the relationship between harsh parenting and child anxiety disorder. Results suggest that parenting may shape children's error processing through environmental conditioning and thereby risk for anxiety, although future work is needed to confirm this

Self-reported and observed punitive parenting prospectively predicts increased error-related brain activity in six-year-old children

Science.gov (United States)

Meyer, Alexandria; Proudfit, Greg Hajcak; Bufferd, Sara J.; Kujawa, Autumn J.; Laptook, Rebecca S.; Torpey, Dana C.; Klein, Daniel N.

2017-01-01

The error-related negativity (ERN) is a negative deflection in the event-related potential (ERP) occurring approximately 50 ms after error commission at fronto-central electrode sites and is thought to reflect the activation of a generic error monitoring system. Several studies have reported an increased ERN in clinically anxious children, and suggest that anxious children are more sensitive to error commission—although the mechanisms underlying this association are not clear. We have previously found that punishing errors results in a larger ERN, an effect that persists after punishment ends. It is possible that learning-related experiences that impact sensitivity to errors may lead to an increased ERN. In particular, punitive parenting might sensitize children to errors and increase their ERN. We tested this possibility in the current study by prospectively examining the relationship between parenting style during early childhood and children’s ERN approximately three years later. Initially, 295 parents and children (approximately 3 years old) participated in a structured observational measure of parenting behavior, and parents completed a self-report measure of parenting style. At a follow-up assessment approximately three years later, the ERN was elicited during a Go/No-Go task, and diagnostic interviews were completed with parents to assess child psychopathology. Results suggested that both observational measures of hostile parenting and self-report measures of authoritarian parenting style uniquely predicted a larger ERN in children 3 years later. We previously reported that children in this sample with anxiety disorders were characterized by an increased ERN. A mediation analysis indicated that ERN magnitude mediated the relationship between harsh parenting and child anxiety disorder. Results suggest that parenting may shape children’s error processing through environmental conditioning and thereby risk for anxiety, although future work is needed to

Student self-reported communication skills, knowledge and confidence across standardised patient, virtual and traditional clinical learning environments.

Science.gov (United States)

Quail, Michelle; Brundage, Shelley B; Spitalnick, Josh; Allen, Peter J; Beilby, Janet

2016-02-27

Advanced communication skills are vital for allied health professionals, yet students often have limited opportunities in which to develop them. The option of increasing clinical placement hours is unsustainable in a climate of constrained budgets, limited placement availability and increasing student numbers. Consequently, many educators are considering the potentials of alternative training methods, such as simulation. Simulations provide safe, repeatable and standardised learning environments in which students can practice a variety of clinical skills. This study investigated students' self-rated communication skill, knowledge, confidence and empathy across simulated and traditional learning environments. Undergraduate speech pathology students were randomly allocated to one of three communication partners with whom they engaged conversationally for up to 30 min: a patient in a nursing home (n = 21); an elderly trained patient actor (n = 22); or a virtual patient (n = 19). One week prior to, and again following the conversational interaction, participants completed measures of self-reported communication skill, knowledge and confidence (developed by the authors based on the Four Habit Coding Scheme), as well as the Jefferson Scale of Empathy - Health Professionals (student version). All three groups reported significantly higher communication knowledge, skills and confidence post-placement (Median d = .58), while the degree of change did not vary as a function of group membership (Median η (2)  communication skill, knowledge and confidence, though not empathy, following a brief placement in a virtual, standardised or traditional learning environment. The self-reported increases were consistent across the three placement types. It is proposed that the findings from this study provide support for the integration of more sustainable, standardised, virtual patient-based placement models into allied health training programs for the training of

Figures in clinical trial reports: current practice & scope for improvement.

Science.gov (United States)

Pocock, Stuart J; Travison, Thomas G; Wruck, Lisa M

2007-11-19

Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assessed for its style, content, clarity and suitability. As a consequence, guidelines are developed for presenting figures, both in general and for each specific common type of Figure. Most trial reports contained one to three figures, mean 2.3 per article. The four main types were flow diagram, Kaplan Meier plot, Forest plot (for subgroup analyses) and repeated measures over time: these accounted for 92% of all figures published. For each type of figure there is a considerable diversity of practice in both style and content which we illustrate with selected examples of both good and bad practice. Some pointers on what to do, and what to avoid, are derived from our critical evaluation of these articles' use of figures. There is considerable scope for authors to improve their use of figures in clinical trial reports, as regards which figures to choose, their style of presentation and labelling, and their specific content. Particular improvements are needed for the four main types of figures commonly used.

Figures in clinical trial reports: current practice & scope for improvement

Directory of Open Access Journals (Sweden)

Travison Thomas G

2007-11-01

Full Text Available Abstract Background Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. Purpose To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. Methods We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assessed for its style, content, clarity and suitability. As a consequence, guidelines are developed for presenting figures, both in general and for each specific common type of Figure. Results Most trial reports contained one to three figures, mean 2.3 per article. The four main types were flow diagram, Kaplan Meier plot, Forest plot (for subgroup analyses and repeated measures over time: these accounted for 92% of all figures published. For each type of figure there is a considerable diversity of practice in both style and content which we illustrate with selected examples of both good and bad practice. Some pointers on what to do, and what to avoid, are derived from our critical evaluation of these articles' use of figures. Conclusion There is considerable scope for authors to improve their use of figures in clinical trial reports, as regards which figures to choose, their style of presentation and labelling, and their specific content. Particular improvements are needed for the four main types of figures commonly used.

Increased Clinical and Neurocognitive Impairment in Children with Autism Spectrum Disorders and Comorbid Bipolar Disorder

Science.gov (United States)

Weissman, Adam S.; Bates, Marsha E.

2010-01-01

Bipolar (BD) symptomatology is prevalent in children with autism spectrum disorders (ASD) and may lead to increased impairment. The current study compared clinical and neurocognitive impairment in children (7-13 years) diagnosed with ASD (n=55), BD (n=34), ASD + BD (n=23), and a non-clinical control group (n=27). Relative to the ASD group, the ASD…

Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR.

Science.gov (United States)

McCowan, Colin; Thomson, Elizabeth; Szmigielski, Cezary A; Kalra, Dipak; Sullivan, Frank M; Prokosch, Hans-Ulrich; Dugas, Martin; Ford, Ian

2015-01-01

The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

Using Electronic Health Records to Support Clinical Trials: A Report on Stakeholder Engagement for EHR4CR

Directory of Open Access Journals (Sweden)

Colin McCowan

2015-01-01

Full Text Available Background. The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Methods. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. Results. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. Conclusions. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform.

Clinical Cancer Advances 2018: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.

Science.gov (United States)

Heymach, John; Krilov, Lada; Alberg, Anthony; Baxter, Nancy; Chang, Susan Marina; Corcoran, Ryan; Dale, William; DeMichele, Angela; Magid Diefenbach, Catherine S; Dreicer, Robert; Epstein, Andrew S; Gillison, Maura L; Graham, David L; Jones, Joshua; Ko, Andrew H; Lopez, Ana Maria; Maki, Robert G; Rodriguez-Galindo, Carlos; Schilsky, Richard L; Sznol, Mario; Westin, Shannon Neville; Burstein, Harold

2018-04-01

A MESSAGE FROM ASCO'S PRESIDENT I remember when ASCO first conceived of publishing an annual report on the most transformative research occurring in cancer care. Thirteen reports later, the progress we have chronicled is remarkable, and this year is no different. The research featured in ASCO's Clinical Cancer Advances 2018 report underscores the impressive gains in our understanding of cancer and in our ability to tailor treatments to tumors' genetic makeup. The ASCO 2018 Advance of the Year, adoptive cell immunotherapy, allows clinicians to genetically reprogram patients' own immune cells to find and attack cancer cells throughout the body. Chimeric antigen receptor (CAR) T-cell therapy-a type of adoptive cell immunotherapy-has led to remarkable results in young patients with acute lymphoblastic leukemia (ALL) and in adults with lymphoma and multiple myeloma. Researchers are also exploring this approach in other types of cancer. This advance would not be possible without robust federal investment in cancer research. The first clinical trial of CAR T-cell therapy in children with ALL was funded, in part, by grants from the National Cancer Institute (NCI), and researchers at the NCI Center for Cancer Research were the first to report on possible CAR T-cell therapy for multiple myeloma. These discoveries follow decades of prior research on immunology and cancer biology, much of which was supported by federal dollars. In fact, many advances that are highlighted in the 2018 Clinical Cancer Advances report were made possible thanks to our nation's support for biomedical research. Funding from the US National Institutes of Health and the NCI helps researchers pursue critical patient care questions and addresses vital, unmet needs that private industry has little incentive to take on. Federally supported cancer research generates the biomedical innovations that fuel the development and availability of new and improved treatments for patients. We need sustained federal

Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

Science.gov (United States)

Bruner, Deborah Watkins; Bryan, Charlene J.; Aaronson, Neil; Blackmore, C. Craig; Brundage, Michael; Cella, David; Ganz, Patricia A.; Gotay, Carolyn; Hinds, Pamela S.; Kornblith, Alice B.; Movsas, Benjamin; Sloan, Jeff; Wenzel, Lari; Whalen, Giles

2016-01-01

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need

Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

Science.gov (United States)

Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

2017-10-01

Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy

Hazard report. Don't use industrial-grade gases for clinical applications.

Science.gov (United States)

2010-01-01

The use of industrial-grade gases instead of medical-grade gases for clinical applications increases the risk of introducing undesirable and even toxic contaminants into the clinical environment. Hospitals should have policies in place to ensure that gases of the appropriate type and grade are used for the intended application.

75 FR 4827 - Submission for OMB Review; Comment Request Clinical Trials Reporting Program (CTRP) Database (NCI)

Science.gov (United States)

2010-01-29

... subsequent comment concerning corruption in clinical trials conducted by large pharmaceutical companies. The... Collection: Title: Clinical Trials Reporting Program (CTRP) Database. Type of Information Collection Request... institutions. Type of Respondents: Clinical research administrators on behalf of clinical investigators. The...

Global Trends in Alzheimer Disease Clinical Development: Increasing the Probability of Success.

Science.gov (United States)

Sugino, Haruhiko; Watanabe, Akihito; Amada, Naoki; Yamamoto, Miho; Ohgi, Yuta; Kostic, Dusan; Sanchez, Raymond

2015-08-01

Alzheimer disease (AD) is a growing global health and economic issue as elderly populations increase dramatically across the world. Despite the many clinical trials conducted, currently no approved disease-modifying treatment exists. In this commentary, the present status of AD drug development and the grounds for collaborations between government, academia, and industry to accelerate the development of disease-modifying AD therapies are discussed. Official government documents, literature, and news releases were surveyed by MEDLINE and website research. Currently approved anti-AD drugs provide only short-lived symptomatic improvements, which have no effect on the underlying pathogenic mechanisms or progression of the disease. The failure to approve a disease-modifying drug for AD may be because the progression of AD in the patient populations enrolled in clinical studies was too advanced for drugs to demonstrate cognitive and functional improvements. The US Food and Drug Administration and the European Medicines Agency recently published draft guidance for industry which discusses approaches for conducting clinical studies with patients in early AD stages. For successful clinical trials in early-stage AD, however, it will be necessary to identify biomarkers highly correlated with the clinical onset and the longitudinal progress of AD. In addition, because of the high cost and length of clinical AD studies, support in the form of global initiatives and collaborations between government, industry, and academia is needed. In response to this situation, national guidance and international collaborations have been established. Global initiatives are focusing on 2025 as a goal to provide new treatment options, and early signs of success in biomarker and drug development are already emerging. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Health status measurement in COPD : the minimal clinically important difference of the clinical COPD questionnaire

NARCIS (Netherlands)

Kocks, J. W. H.; Tuinenga, M. G.; Uil, S. M.; van den Berg, J. W. K.; Stahl, E.; van der Molen, T.

2006-01-01

Background: Patient-reported outcomes ( PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for

The 7q11.23 Microduplication Syndrome: A Clinical Report with Review of Literature

OpenAIRE

Abbas, Elham; Cox, Devin M.; Smith, Teri; Butler, Merlin G.

2016-01-01

We report a 14-year-old adolescent girl with selective mutism (SM) and a 7q11.23 microduplication detected by chromosomal microarray (CMA) analysis and reviewed the literature from 18 published clinical reports. Our patient had specific phobias, SM, extreme anxiety, obesity, cutis marmorata, and a round appearing face with a short neck and over folded ears. We reviewed the published clinical, cognitive, behavioral, and cytogenetic findings grouped by speech and language delay, growth and deve...

Clinical Investigation Program Report, RCS MED-300 (R1).

Science.gov (United States)

1986-10-31

handpieces . Technical Approach: The study will be conducted in vitro using the palatal roots of human maxillary molar teeth which previously extracted due...109 1985 Histoplasmosis Seroconversion Study. (T) 110 1986 A Comparative Study of Fetal Movement Perceptions in the Third Trimester of Multiparous and...Hartwell G, Portell FR: Clinical management of middle mesial root canals in mandibular molars : Two case reports. Submitted to J Am Dent Assn. DeFiore

Prosthetic rehabilitation of a patient after partial maxillectomy: A clinical report

Directory of Open Access Journals (Sweden)

Shobha J Rodrigues

2011-01-01

Full Text Available Malignant melanoma of the oral cavity is very rare. This clinical report describes a method for prosthetic rehabilitation of a patient with malignant melanoma of the palate following partial maxillectomy with a closed hollow interim obturator.

First report of oligodendroglioma in a sheep : clinical communication

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A. Derakhshanfar

2010-05-01

Full Text Available Oligodendrogliomas occur most commonly in the dog, but have also been reported in cattle, horses and cats. A 1-year-old sheep with neurological disturbances, including blindness, ataxia, circling and incoordination was referred to the veterinary clinic of Shahid Bahonar University of Kerman. Following euthanasia and necropsy, a soft, relatively well-demarcated mass was observed in the white and grey matter of the right cerebral hemisphere, close to the sylvian fissure in the right cerebral hemisphere. Microscopic examination revealed a sheet of densely packed tumour cells with hyperchromatic nuclei, lightly staining cytoplasm and characteristic perinuclear halo effect which is consistent with a diagnosis of oligodendroglioma. This is the 1st report of oligodendroglioma in sheep.

Use of social media and college student organizations to increase support for organ donation and advocacy: a case report.

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D'Alessandro, Anthony M; Peltier, James W; Dahl, Andrew J

2012-12-01

This report focuses on the University of Wisconsin Hospital and Clinics organ procurement organization's efforts to increase deceased organ and tissue donation by using social media and personalized messages targeting members of university student organizations, their families, and their friends. A grant from the US Department of Health and Human Services funded a 2-year study to (1) identify barriers/opportunities for increasing awareness, attitudes, and behaviors related to organ and tissue donation; (2) implement an intervention using social media and personalized message to increase knowledge, support, and donor registrations; (3) measure impact on awareness and attitudinal and behavioral changes within the organization; and (4) assess behavioral measures across a host of social media analytics and organ donor registrations. The results show increases in knowledge about and support for organ donation, including a 20% increase in donor registration. As a result, funding was secured to continue the project for an additional 2 years.

Use of quantification in cardiac reporting: How does it change the clinical result?

International Nuclear Information System (INIS)

Gnanasegaran, G.; Hilson, A.J.W.; Buscombe, J.R.

2005-01-01

Many gamma camera systems are now sold with cardiac quantification packages. These are said to increase the accuracy of reporting. However the use of such quantification packages may change the clinical report as read from the tomographic slices. The aim of this study was to quantify the differences between qualitative visual reporting and quantification. The stress and rest myocardial perfusion studies were quantitatively reported in 37 patients comprising 333 segments of the heart (9 segments/patient). A defect was defined by a reduction in activity of >50% in each of the segments. For the tomographic qualitative reporting the data was reconstructed using iterative reconstruction with a Wiener smoothing filter. Quantification used an Emory bull's eye system with gender and age matched normal controls. Number of abnormal segments noted by qualitative reading of data were 119 at stress and 79 at rest. For the bull's eye plot 98 abnormal segments were seen at stress and 76 at rest. Thirty-three segments (10%) were abnormal on the qualitative reading of data alone and 7 (2%) were abnormal on bull's eye alone. Of the 55 segments reported as ischaemic qualitative reading of data, 26 (48%) were normal on bull's eye, 13 of these in the right coronary artery (RCA) territory segments. Of the 67 segments reported on the qualitative reading of data as infarct, 10 (13%) were normal on bull's eye, 7 of these in the territory of the RCA segments. There are significant differences in the results of reporting scans using a bull's eye plot especially in identifying inferior wall ischaemia. Therefore before using such a quantification method a full assessment of the accuracy of each method should be performed. (author)

CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE QUALITY OF DXA SCANS AND REPORTS.

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Licata, Angelo A; Binkley, Neil; Petak, Steven M; Camacho, Pauline M

2018-02-01

High-quality dual-energy X-ray absorptiometry (DXA) scans are necessary for accurate diagnosis of osteoporosis and monitoring of therapy; however, DXA scan reports may contain errors that cause confusion about diagnosis and treatment. This American Association of Clinical Endocrinologists/American College of Endocrinology consensus statement was generated to draw attention to many common technical problems affecting DXA report conclusions and provide guidance on how to address them to ensure that patients receive appropriate osteoporosis care. The DXA Writing Committee developed a consensus based on discussion and evaluation of available literature related to osteoporosis and osteodensitometry. Technical errors may include errors in scan acquisition and/or analysis, leading to incorrect diagnosis and reporting of change over time. Although the International Society for Clinical Densitometry advocates training for technologists and medical interpreters to help eliminate these problems, many lack skill in this technology. Suspicion that reports are wrong arises when clinical history is not compatible with scan interpretation (e.g., dramatic increase/decrease in a short period of time; declines in previously stable bone density after years of treatment), when different scanners are used, or when inconsistent anatomic sites are used for monitoring the response to therapy. Understanding the concept of least significant change will minimize erroneous conclusions about changes in bone density. Clinicians must develop the skills to differentiate technical problems, which confound reports, from real biological changes. We recommend that clinicians review actual scan images and data, instead of relying solely on the impression of the report, to pinpoint errors and accurately interpret DXA scan images. AACE = American Association of Clinical Endocrinologists; BMC = bone mineral content; BMD = bone mineral density; DXA = dual-energy X-ray absorptiometry; ISCD = International

The clinical case report: a review of its merits and limitations.

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Nissen, Trygve; Wynn, Rolf

2014-04-23

The clinical case report has a long-standing tradition in the medical literature. While its scientific significance has become smaller as more advanced research methods have gained ground, case reports are still presented in many medical journals. Some scholars point to its limited value for medical progress, while others assert that the genre is undervalued. We aimed to present the various points of view regarding the merits and limitations of the case report genre. We searched Google Scholar, PubMed and select textbooks on epidemiology and medical research for articles and book-chapters discussing the merits and limitations of clinical case reports and case series. The major merits of case reporting were these: Detecting novelties, generating hypotheses, pharmacovigilance, high applicability when other research designs are not possible to carry out, allowing emphasis on the narrative aspect (in-depth understanding), and educational value. The major limitations were: Lack of ability to generalize, no possibility to establish cause-effect relationship, danger of over-interpretation, publication bias, retrospective design, and distraction of reader when focusing on the unusual. Despite having lost its central role in medical literature in the 20th century, the genre still appears popular. It is a valuable part of the various research methods, especially since it complements other approaches. Furthermore, it also contributes in areas of medicine that are not specifically research-related, e.g. as an educational tool. Revision of the case report genre has been attempted in order to integrate the biomedical model with the narrative approach, but without significant success. The future prospects of the case report could possibly be in new applications of the genre, i.e. exclusive case report databases available online, and open access for clinicians and researchers.

Comorbid personality disorders in subjects with panic disorder: which personality disorders increase clinical severity?

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Mustafa Ozkan

2003-03-01

Full Text Available Personality disorders are common in subjects with panic disorder. Personality disorders have shown to affect the course of panic disorder. The purpose of this study was to examine which personality disorders effect clinical severity in subjects with panic disorder. This study included 122 adults (71 female, 41 male, who met DSM-IV criteria for panic disorder (with or without agoraphobia. Clinical assessment was conducted by using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I, the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II and the Panic and Agoraphobia Scale (PAS, Global Assessment Functioning Scale (GAF, Beck Depression Inventory (BDI, and State-Trait Anxiety Inventory (STAI. Patients who had a history of sexual abuse were assessed with Sexual Abuse Severity Scale. Logistic regressions were used to identify predictors of suicide attempts, suicidal ideation, agoraphobia, different panic attack symptoms, sexual abuse, and early onset of disorders. The rates of comorbid Axis I and Axis II psychiatric disorders were 80.3% and 33.9%, consecutively, in patients with panic disorder. Panic disorder patients with comorbid personality disorders had more severe anxiety, depression and agoraphobia symptoms, and had earlier ages of onset, and lower levels of functioning. The rates of suicidal ideation and suicide attempts were 34.8% and 9.8%, consecutively, in subjects with panic disorder. The rate of patients with panic disorder had a history of childhood sexual abuse was 12.5%. The predictor of sexual abuse was more than one comorbid Axis II diagnosis. The predictors of suicide attempt were comorbid paranoid and borderline personality disorders, and the predictor of suicidal ideation was major depressive disorder in subjects with panic disorder. In conclusion, this study documents that comorbid personality disorders increase the clinical severity of panic disorder. Patients with more than one

Methylene blue for clinical anaphylaxis treatment: a case report

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Janine Moreira Rodrigues

Full Text Available CONTEXT AND OBJECTIVE: Nitric oxide has a pathophysiological role in modulating systemic changes associated with anaphylaxis. Nitric oxide synthase inhibitors may exacerbate bronchospasm in anaphylaxis and worsen clinical conditions, with limited roles in anaphylactic shock treatment. The aim here was to report an anaphylaxis case (not anaphylactic shock, reversed by methylene blue (MB, a guanylyl cyclase inhibitor. CASE REPORT: A 23-year-old female suddenly presented urticaria and pruritus, initially on her face and arms, then over her whole body. Oral antihistamine was administered initially, but without improvement in symptoms and signs until intravenous methylprednisolone 500 mg. Recurrence occurred after two hours, plus vomiting. Associated upper respiratory distress, pulmonary sibilance, laryngeal stridor and facial angioedema (including erythema and lip edema marked the evolution. At sites with severe pruritus, petechial lesions were observed. The clinical situation worsened, with dyspnea, tachypnea, peroral cyanosis, laryngeal edema with severe expiratory dyspnea and deepening unconsciousness. Conventional treatment was ineffective. Intubation and ventilatory support were then considered, because of severe hypoventilation. But, before doing that, based on our previous experience, 1.5 mg/kg (120 mg bolus of 4% MB was infused, followed by one hour of continuous infusion of another 120 mg diluted in dextrose 5% in water. Following the initial intravenous MB dose, the clinical situation reversed completely in less than 20 minutes, thereby avoiding tracheal intubation. CONCLUSION: Although the nitric oxide hypothesis for MB effectiveness discussed here remains unproven, our intention was to share our accumulated cohort experience, which strongly suggests MB is a lifesaving treatment for anaphylactic shock and/or anaphylaxis and other vasoplegic conditions.

Hepatic veno-occlusive disease during chemotherapy for nephroblastoma: successful and safe treatment with defibrotide. Report of a clinical case.

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Cecinati, Valerio; Giordano, Paola; De Leonardis, Francesco; Grassi, Massimo; Arcamone, Giampaolo; De Mattia, Domenico; Santoro, Nicola

2009-01-01

Here we report a case of administration of defibrotide in an 11 months old infant with hepatic veno-occlusive disease during chemotherapy for nephroblastoma. He presented with abdominal distension, a weight gain of 15%, ascites, hepatomegaly with right upper quadrant pain, thrombocytopenia and hypertransaminasemia. Despite therapy, his clinical conditions aggravated, and, therefore intravenous administration of defibrotide on a compassionate-use basis was started. The dosage was 15 mg/kg/day in 4 divided doses, which was increased gradually (in 3 days) to 40 mg/kg/day in 4 divided doses. Defibrotide proved safe and effective in resolving clinical symptoms and normalizing serological findings in the syndrome.

Clinical microbiology informatics.

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Rhoads, Daniel D; Sintchenko, Vitali; Rauch, Carol A; Pantanowitz, Liron

2014-10-01

The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

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R. Andrew Moore

2018-01-01

Full Text Available We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n=519, gynaecological surgery (3 trials, n=679, and dysmenorrhoea (2 trials, n=711 conducted in 1988–1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9–2.6 and 2.1 (1.8–2.4 for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.

STD screening, testing, case reporting, and clinical and partner notification practices: a national survey of US physicians.

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St Lawrence, Janet S; Montaño, Daniel E; Kasprzyk, Danuta; Phillips, William R; Armstrong, Keira; Leichliter, Jami S

2002-11-01

This study presents results from a national survey of US physicians that assessed screening, case reporting, partner management, and clinical practices for syphilis, gonorrhea, chlamydia, and HIV infection. Surveys were mailed to a random sample of 7300 physicians to assess screening, testing, reporting, and partner notification for syphilis, gonorrhea, chlamydia, and HIV. Fewer than one third of physicians routinely screened men or women (pregnant or nonpregnant) for STDs. Case reporting was lowest for chlamydia (37 percent), intermediate for gonorrhea (44 percent), and higher for syphilis, HIV, and AIDS (53 percent-57 percent). Physicians instructed patients to notify their partners (82 percent-89 percent) or the health department (25 percent-34 percent) rather than doing so themselves. STD screening levels are well below practice guidelines for women and virtually nonexistent for men. Case reporting levels are below those legally mandated; physicians rely instead on patients for partner notification. Health departments must increase collaboration with private physicians to improve the quality of STD care.

Is Internet Pornography Causing Sexual Dysfunctions? A Review with Clinical Reports

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Park, Brian Y.; Wilson, Gary; Berger, Jonathan; Christman, Matthew; Reina, Bryn; Bishop, Frank; Klam, Warren P.; Doan, Andrew P.

2016-01-01

Traditional factors that once explained men’s sexual difficulties appear insufficient to account for the sharp rise in erectile dysfunction, delayed ejaculation, decreased sexual satisfaction, and diminished libido during partnered sex in men under 40. This review (1) considers data from multiple domains, e.g., clinical, biological (addiction/urology), psychological (sexual conditioning), sociological; and (2) presents a series of clinical reports, all with the aim of proposing a possible direction for future research of this phenomenon. Alterations to the brain's motivational system are explored as a possible etiology underlying pornography-related sexual dysfunctions. This review also considers evidence that Internet pornography’s unique properties (limitless novelty, potential for easy escalation to more extreme material, video format, etc.) may be potent enough to condition sexual arousal to aspects of Internet pornography use that do not readily transition to real-life partners, such that sex with desired partners may not register as meeting expectations and arousal declines. Clinical reports suggest that terminating Internet pornography use is sometimes sufficient to reverse negative effects, underscoring the need for extensive investigation using methodologies that have subjects remove the variable of Internet pornography use. In the interim, a simple diagnostic protocol for assessing patients with porn-induced sexual dysfunction is put forth. PMID:27527226

Measuring Disability in Population Based Surveys: The Interrelationship between Clinical Impairments and Reported Functional Limitations in Cameroon and India.

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Mactaggart, Islay; Kuper, Hannah; Murthy, G V S; Oye, Joseph; Polack, Sarah

2016-01-01

To investigate the relationship between two distinct measures of disability: self-reported functional limitations and objectively-screened clinical impairments. We undertook an all age population-based survey of disability in two areas: North-West Cameroon (August/October 2013) and Telangana State, India (Feb/April 2014). Participants were selected for inclusion via two-stage cluster randomised sampling (probability proportionate to size cluster selection and compact segment sampling within clusters). Disability was defined as the presence of self-reported functional limitations across eight domains, or presence of moderate or greater clinical impairments. Clinical impairment screening comprised of visual acuity testing for vision impairment, pure tone audiometry for hearing impairment, musculoskeletal functioning assessment for musculoskeletal impairment, reported seizure history for epilepsy and reported symptoms of clinical depression (depression adults only). Information was collected using structured questionnaires, observations and examinations. Self-reported disability prevalence was 5.9% (95% CI 4.7-7.4) and 7.5% (5.9-9.4) in Cameroon and India respectively. The prevalence of moderate or greater clinical impairments in the same populations were 8.4% (7.5-9.4) in Cameroon and 10.5% (9.4-11.7) in India. Overall disability prevalence (self-report and/or screened positive to a moderate or greater clinical impairment) was 10.5% in Cameroon and 12.2% in India, with limited overlap between the sub-populations identified using the two types of tools. 33% of participants in Cameroon identified to have a disability, and 45% in India, both reported functional limitations and screened positive to objectively-screened impairments, whilst the remainder were identified via one or other tool only. A large proportion of people with moderate or severe clinical impairments did not self-report functional difficulties despite reporting participation restrictions. Tools to

Harmonizing and consolidating the measurement of patient-reported information at health care institutions: a position statement of the Mayo Clinic

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Eton DT

2014-02-01

Full Text Available David T Eton,1,2 Timothy J Beebe,1,2 Philip T Hagen,3 Michele Y Halyard,4 Victor M Montori,1,5 James M Naessens,1,2 Jeff A Sloan,6 Carrie A Thompson,7 Douglas L Wood1,81Division of Heath Care Policy and Research, Department of Health Sciences Research, 2Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, 3Department of Preventive, Occupational, and Aerospace Medicine, Mayo Clinic, Rochester, MN, 4Department of Radiation Oncology, Mayo Clinic, Scottsdale, AZ, 5Knowledge and Evaluation Research Unit, 6Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, 7Division of Hematology, Department of Medicine, 8Center for Innovation, Mayo Clinic, Rochester, MN, USAAbstract: Patient-reported outcomes (PROs capture how patients perceive their health and their health care; their use in clinical research is longstanding. Today, however, PROs increasingly are being used to inform the care of individual patients, and document the performance of health care entities. We recently wrote and internally distributed an institutional position statement titled "Harmonizing and Consolidating the Measurement of Patient-Reported Outcomes at Mayo Clinic: A Position Statement for the Center for the Science of Health Care Delivery". The statement is meant to educate clinicians, clinical teams, and institutional administrators about the merits of using PROs in a systematic manner for clinical care and quality measurement throughout the institution. The present article summarizes the most important messages from the statement, describing PROs and their use, identifying practical considerations for implementing them in routine practice, elucidating potential barriers to their use, and formulating strategies to overcome these barriers. The lessons learned from our experience – including pitfalls, challenges, and successes – may inform other health care institutions that are interested in

How well do radiographic, clinical and self-reported diagnoses of knee osteoarthritis agree? Findings from the Hertfordshire cohort study.

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Parsons, Camille; Clynes, Michael; Syddall, Holly; Jagannath, Darshan; Litwic, Anna; van der Pas, Suzan; Cooper, Cyrus; Dennison, Elaine M; Edwards, Mark H

2015-01-01

Epidemiological studies of knee osteoarthritis (OA) have often used a radiographic definition. However, the clinical syndrome of OA is influenced by a broad range of factors in addition to the structural changes required for radiographic OA. Hence more recently several studies have adopted a clinical or self-reported approach to OA diagnosis rather than a radiographic approach. The aim of this study was to investigate agreement between radiographic OA and the clinical and self-reported diagnoses of OA. Data were available for 199 men and 196 women in the Hertfordshire Cohort Study (HCS), UK. Participants completed a questionnaire detailing self-reported OA. Clinical OA was defined based on American College of Rheumatology (ACR) criteria. Knee radiographs were taken and graded for overall Kellgren and Lawrence (K&L) score. The mean (standard deviation (SD)) age of study participants was 75.2 (2.6) years and almost identical proportions of men and women. The prevalence of knee OA differed depending on the method employed for diagnosis; 21% of the study participants self-reported knee OA, 18% of the participants had clinical knee OA and 42% of the participants had radiographic OA. Of those 72 study participants with a self-reported diagnosis of knee OA 52 (72%) had a radiographic diagnosis of knee OA, while 66% (39 out of 59) of study participants with clinical knee OA had a diagnosis of radiographic knee OA. However 58% of those participants diagnosed with radiographic OA did not have either self-reported knee OA or a diagnosis of clinical OA. Therefore in comparison with the radiographic definition of OA, both the clinical and self-report definitions had high specificity (91.5% & 91.5% respectively) and low sensitivity (24.5% and 32.7% respectively). There is modest agreement between the radiographic, clinical and self-report methods of diagnosis of knee OA.

Describing the implementation of an innovative intervention and evaluating its effectiveness in increasing research capacity of advanced clinical nurses: using the consolidated framework for implementation research.

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McKee, Gabrielle; Codd, Margaret; Dempsey, Orla; Gallagher, Paul; Comiskey, Catherine

2017-01-01

Despite advanced nursing roles having a research competency, participation in research is low. There are many barriers to participation in research and few interventions have been developed to address these. This paper aims to describe the implementation of an intervention to increase research participation in advanced clinical nursing roles and evaluate its effectiveness. The implementation of the intervention was carried out within one hospital site. The evaluation utilised a mixed methods design and a implementation science framework. All staff in advanced nursing roles were invited to take part, all those who were interested and had a project in mind could volunteer to participate in the intervention. The intervention consisted of the development of small research groups working on projects developed by the nurse participant/s and supported by an academic and a research fellow. The main evaluation was through focus groups. Output was analysed using thematic analysis. In addition, a survey questionnaire was circulated to all participants to ascertain their self-reported research skills before and after the intervention. The results of the survey were analysed using descriptive statistics. Finally an inventory of research outputs was collated. In the first year, twelve new clinical nurse-led research projects were conducted and reported in six peer reviewed papers, two non-peer reviewed papers and 20 conference presentations. The main strengths of the intervention were its promptness to complete research, to publish and to showcase clinical innovations. Main barriers identified were time, appropriate support from academics and from peers. The majority of participants had increased experience at scientific writing and data analysis. This study shows that an intervention, with minor financial resources; a top down approach; support of a hands on research fellow; peer collaboration with academics; strong clinical ownership by the clinical nurse researcher

Impact of a clinical guideline for prescribing antibiotics to inpatients reporting penicillin or cephalosporin allergy.

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Blumenthal, Kimberly G; Shenoy, Erica S; Varughese, Christy A; Hurwitz, Shelley; Hooper, David C; Banerji, Aleena

2015-10-01

Self-reported penicillin allergy infrequently reflects an inability to tolerate penicillins. Inpatients reporting penicillin allergy receive alternative antibiotics that might be broader spectrum, more toxic, or less effective. To develop and assess a clinical guideline for the general inpatient provider that directs taking a history and prescribing antibiotics for patients with penicillin or cephalosporin allergy. A guideline was implemented to assist providers with assessing allergy history and prescribing antibiotics for patients with reported penicillin or cephalosporin allergy. The guideline used a standard 2-step graded challenge or test dose. A quasi-experimental study was performed to assess safety, feasibility, and impact on antibiotic use by comparing treatment 21 months before guideline implementation with 12 months after guideline implementation. Significantly more test doses to β-lactam antibiotics were performed monthly after vs before guideline implementation (median 14.5, interquartile range 13-16.25, vs 2, interquartile range 1-3.25, P  .5) between periods. Guideline-driven test doses decreased alternative antimicrobial therapy after the test dose, including vancomycin (68.3% vs 37.2%, P penicillin or cephalosporin allergy was associated with an almost 7-fold increase in the number of test doses to β-lactams without increased adverse drug reactions. Patients assessed with guideline-driven test doses were observed to have significantly decreased alternative antibiotic exposure. Copyright © 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov.

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Law, Michael R; Kawasumi, Yuko; Morgan, Steven G

2011-12-01

Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate's deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.

Multiparametric prostate MRI: technical conduct, standardized report and clinical use.

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Manfredi, Matteo; Mele, Fabrizio; Garrou, Diletta; Walz, Jochen; Fütterer, Jurgen J; Russo, Filippo; Vassallo, Lorenzo; Villers, Arnauld; Emberton, Mark; Valerio, Massimo

2018-02-01

Multiparametric prostate MRI (mp-MRI) is an emerging imaging modality for diagnosis, characterization, staging, and treatment planning of prostate cancer (PCa). The technique, results reporting, and its role in clinical practice have been the subject of significant development over the last decade. Although mp-MRI is not yet routinely used in the diagnostic pathway, almost all urological guidelines have emphasized the potential role of mp-MRI in several aspects of PCa management. Moreover, new MRI sequences and scanning techniques are currently under evaluation to improve the diagnostic accuracy of mp-MRI. This review presents an overview of mp-MRI, summarizing the technical applications, the standardized reporting systems used, and their current roles in various stages of PCa management. Finally, this critical review also reports the main limitations and future perspectives of the technique.

Formative Evaluation of Clinician Experience with Integrating Family History-Based Clinical Decision Support into Clinical Practice

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Megan Doerr

2014-03-01

Full Text Available Family health history is a leading predictor of disease risk. Nonetheless, it is underutilized to guide care and, therefore, is ripe for health information technology intervention. To fill the family health history practice gap, Cleveland Clinic has developed a family health history collection and clinical decision support tool, MyFamily. This report describes the impact and process of implementing MyFamily into primary care, cancer survivorship and cancer genetics clinics. Ten providers participated in semi-structured interviews that were analyzed to identify opportunities for process improvement. Participants universally noted positive effects on patient care, including increases in quality, personalization of care and patient engagement. The impact on clinical workflow varied by practice setting, with differences observed in the ease of integration and the use of specific report elements. Tension between the length of the report and desired detail was appreciated. Barriers and facilitators to the process of implementation were noted, dominated by the theme of increased integration with the electronic medical record. These results fed real-time improvement cycles to reinforce clinician use. This model will be applied in future institutional efforts to integrate clinical genomic applications into practice and may be useful for other institutions considering the implementation of tools for personalizing medical management.

Research and Clinical Center for Child Development Annual Report, 1994-1995, No. 18.

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Wakai, Kunio, Ed.; Chen, Shing-Jen, Ed.

This annual report discusses several topics related to the work of the Research and Clinical Center for Child Development. Seven topics are covered in the report. The articles are: (1) "Fathers' Participation in the Lives of Their 4-Month-Old Infants: The United States and Japan" (Marguerite Stevenson Barratt, Koichi Negayama and…

Reliability of Diagnosing Clinical Hypothyroidism in Adults with Down Syndrome. Brief Report.

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Prasher, V. P.

1995-01-01

The accuracy of diagnosing hypothyroidism in 160 adults with Down syndrome was examined. A significant association between a clinical diagnosis of hypothyroidism and increasing age was found but no significant association was found between a clinical and a biochemical diagnosis. Regular biochemical screening is recommended. (Author/SW)

Notes from the Field: Increase in Neisseria meningitidis-Associated Urethritis Among Men at Two Sentinel Clinics - Columbus, Ohio, and Oakland County, Michigan, 2015.

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Bazan, Jose A; Peterson, Amy S; Kirkcaldy, Robert D; Briere, Elizabeth C; Maierhofer, Courtney; Turner, Abigail Norris; Licon, Denisse B; Parker, Nicole; Dennison, Amanda; Ervin, Melissa; Johnson, Laura; Weberman, Barbara; Hackert, Pamela; Wang, Xin; Kretz, Cecilia B; Abrams, A Jeanine; Trees, David L; Del Rio, Carlos; Stephens, David S; Tzeng, Yih-Ling; DiOrio, Mary; Roberts, Mysheika Williams

2016-06-03

Neisseria meningitidis (Nm) urogenital infections, although less common than infections caused by Neisseria gonorrhoeae (Ng), have been associated with urethritis, cervicitis, proctitis, and pelvic inflammatory disease. Nm can appear similar to Ng on Gram stain analysis (gram-negative intracellular diplococci) (1-5). Because Nm colonizes the nasopharynx, men who receive oral sex (fellatio) can acquire urethral Nm infections (1,3,5). This report describes an increase in Nm-associated urethritis in men attending sexual health clinics in Columbus, Ohio, and Oakland County, Michigan.

Self-Reported Visual Perceptual Abnormalities Are Strongly Associated with Core Clinical Features in Psychotic Disorders

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Brian P. Keane

2018-03-01

Full Text Available BackgroundPast studies using the Bonn Scale for the Assessment of Basic Symptoms (hereafter, Bonn Scale have shown that self-reported perceptual/cognitive disturbances reveal which persons have or will soon develop schizophrenia. Here, we focused specifically on the clinical value of self-reported visual perceptual abnormalities (VPAs since they are underexplored and have been associated with suicidal ideation, negative symptoms, and objective visual dysfunction.MethodUsing the 17 Bonn Scale vision items, we cross-sectionally investigated lifetime occurrence of VPAs in 21 first-episode psychosis and 22 chronic schizophrenia/schizoaffective disorder (SZ/SA patients. Relationships were probed between VPAs and illness duration, symptom severity, current functioning, premorbid functioning, diagnosis, and age of onset.ResultsIncreased VPAs were associated with: earlier age of onset; more delusions, hallucinations, bizarre behavior, and depressive symptoms; and worse premorbid social functioning, especially in the childhood and early adolescent phases. SZ/SA participants endorsed more VPAs as compared to those with schizophreniform or psychotic disorder-NOS, especially in the perception of color, bodies, faces, object movement, and double/reversed vision. The range of self-reported VPAs was strikingly similar between first-episode and chronic patients and did not depend on the type or amount of antipsychotic medication. As a comparative benchmark, lifetime occurrence of visual hallucinations did not depend on diagnosis and was linked only to poor premorbid social functioning.ConclusionA brief 17-item interview derived from the Bonn Scale is strongly associated with core clinical features in schizophrenia. VPAs hold promise for clarifying diagnosis, predicting outcome, and guiding neurocognitive investigations.

Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

Science.gov (United States)

Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

2014-01-01

Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient

Advancing medicine one research note at a time: the educational value in clinical case reports

Directory of Open Access Journals (Sweden)

Cabán-Martinez Alberto J

2012-07-01

Full Text Available Abstract A case report—a brief written note that describes unique aspects of a clinical case—provides a significant function in medicine given its rapid, succinct, and educational contributions to scientific literature and clinical practice. Despite the growth of, and emphasis on, randomized clinical trials and evidenced-based medicine, case reports continue to provide novel and exceptional knowledge in medical education. The journal BMC Research Notes introduces a new “case reports” section to provide the busy clinician with a forum in which to document any authentic clinical case that provide educational value to current clinical practice. The aim is for this article type to be reviewed, wherever possible, by specialized Associate Editors for the journal, in order to provide rapid but thorough decision making. New ideas often garnered by and documented in case reports will support the advancement of medical science — one research note at a time.

Teen Pregnancy and School-Based Health Clinics. A Family Research Report.

Science.gov (United States)

Mosbacker, Barrett

To combat the problem of teenage pregnancy, public health clinics have made birth control counseling and free contraceptives available to minors and many public schools have implemented sex education programs. Despite the development and implementation of these programs, teenage sexual activity and pregnancy have increased. The increase in…

Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

Directory of Open Access Journals (Sweden)

Kent David M

2010-08-01

Full Text Available Abstract Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important heterogeneity in treatment effects (HTE across the trial population, such that the balance between treatment risks and benefits may differ substantially between large identifiable patient subgroups; the "average" benefit observed in the summary result may even be non-representative of the treatment effect for a typical patient in the trial. Conventional subgroup analyses, which examine whether specific patient characteristics modify the effects of treatment, are usually unable to detect even large variations in treatment benefit (and harm across risk groups because they do not account for the fact that patients have multiple characteristics simultaneously that affect the likelihood of treatment benefit. Based upon recent evidence on optimal statistical approaches to assessing HTE, we propose a framework that prioritizes the analysis and reporting of multivariate risk-based HTE and suggests that other subgroup analyses should be explicitly labeled either as primary subgroup analyses (well-motivated by prior evidence and intended to produce clinically actionable results or secondary (exploratory subgroup analyses (performed to inform future research. A standardized and transparent approach to HTE assessment and reporting could substantially improve clinical trial utility and interpretability.

Interconnecting smartphone, image analysis server, and case report forms in clinical trials for automatic skin lesion tracking in clinical trials

Science.gov (United States)

Haak, Daniel; Doma, Aliaa; Gombert, Alexander; Deserno, Thomas M.

2016-03-01

Today, subject's medical data in controlled clinical trials is captured digitally in electronic case report forms (eCRFs). However, eCRFs only insufficiently support integration of subject's image data, although medical imaging is looming large in studies today. For bed-side image integration, we present a mobile application (App) that utilizes the smartphone-integrated camera. To ensure high image quality with this inexpensive consumer hardware, color reference cards are placed in the camera's field of view next to the lesion. The cards are used for automatic calibration of geometry, color, and contrast. In addition, a personalized code is read from the cards that allows subject identification. For data integration, the App is connected to an communication and image analysis server that also holds the code-study-subject relation. In a second system interconnection, web services are used to connect the smartphone with OpenClinica, an open-source, Food and Drug Administration (FDA)-approved electronic data capture (EDC) system in clinical trials. Once the photographs have been securely stored on the server, they are released automatically from the mobile device. The workflow of the system is demonstrated by an ongoing clinical trial, in which photographic documentation is frequently performed to measure the effect of wound incision management systems. All 205 images, which have been collected in the study so far, have been correctly identified and successfully integrated into the corresponding subject's eCRF. Using this system, manual steps for the study personnel are reduced, and, therefore, errors, latency and costs decreased. Our approach also increases data security and privacy.

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.

Science.gov (United States)

Rolfes, Leàn; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugène

2017-07-01

Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. A retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient's healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test. A total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126). In a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

Case Reports of Cat Scratch Disease with Typical and Atypical Clinical Manifestations: A Literature Review

Directory of Open Access Journals (Sweden)

Gulshan Umbreen

2017-04-01

Full Text Available Cat scratch disease (CSD is the most well-known zoonotic disease spread by domestic animals like cats. Cats are the source of Bartonella henselae. Most patients more than ninety percent 3-12 days after a scratch from a cat, undoubtedly a little cat with insects present with one or more erythematous injuries at the site of inoculation, the sore is typically a crusted papule or, once in a while, a pustule. More than half of cases in one study show that the systemic indications went with the lymphadenopathy. These may incorporate fever, discomfort, migraine and anorexia and frequently happen in immunocompromised patients. Atypically clinical manifestations happen are altered mental status, perplexity, prolonged fever, respiratory protestations (atypical pneumonitis, Joint pain, synovitis, Back agony is uncommon. The hypothesis of the study to find out that cat scratch disease cause typical and atypical clinical manifestation. Study was conducted July 2015 to September 2015. The methodology sections of a review article are listed all of the databases and citation indexes that were searched such as Web of Science and PubMed and any individual journals that were searched. Various case reports were mentioned in the study. Case reports of cat scratch diseases with typical and atypical clinical manifestation included in the study. The objective of review of these reporting cases is to make physicians aware about cat scratch diseases and also need to create awareness about cat scratch disease in pet owner. Although it is self-limiting needs to report to health authorities. There are few cases reported in which mostly cases reported in twain, japan, Brazil, Texas, United States, Dhaka, Spain with typical and atypical clinical manifestation

Increased plantar foot pressure in persons affected by leprosy

NARCIS (Netherlands)

Slim, Frederik J.; van Schie, Carine H.; Keukenkamp, Renske; Faber, William R.; Nollet, Frans

2012-01-01

Although foot pressure has been reported to be increased in people affected by leprosy, studies on foot pressure and its determinants are limited. Therefore, the aim was to assess barefoot plantar foot pressure and to identify clinical determinants of increased plantar foot pressure in leprosy

The patient-physician partnership in asthma: real-world observations associated with clinical and patient-reported outcomes.

Science.gov (United States)

Small, M; Vickers, A; Anderson, P; Kay, S

2010-09-01

It is hypothesized that a good partnership between asthma patients and their physicians has a direct and positive influence on the patients' clinical and patient-reported outcomes. Conversely, poor partnership has a detrimental effect on clinical and patient-reported outcomes. This paper uses data from a real-world observational study to define partnership through matched physician and patient data and correlate the quality of partnership with observed clinical and patient-reported outcomes. Data were drawn from Adelphi's Respiratory Disease Specific Programme, a cross-sectional study of consulting patients in five European countries undertaken between June and September 2009. A range of clinical and patient-reported outcomes were observed allowing analysis of the partnership between 2251 asthma patients and their physicians. Analysis demonstrates that the better the partnership between patient and physician, the more likely the patient is to have their asthma condition controlled (PPartnership is also associated with lower impact on lifestyle (Ppartnership is a contributory factor in the improvement of asthma treatment, and patient education may lead to improvement in a patient's ability to contribute to this. Device satisfaction is one of the markers of good partnership.

A Report of Six Clinical Cases of Lowered Blood Cholesterol Profile ...

African Journals Online (AJOL)

Purpose: To assess six patients with Diabegard® supplementation with reference to cholesterol profiles. Methods: We report the clinical courses of six individuals taking Diabegard® supplementation at 60 and 120 mg/day for 8 weeks. Results: Patients had a maximum of 52.13 % reduction in low-density lipoprotein (LDL) ...

Cost-effectiveness of increasing bisphosphonates adherence for osteoporosis in community pharmacies

NARCIS (Netherlands)

Van Boven, J.F.M.; Oosterhof, P.; Hiddink, E.G.; Stuurman-Bieze, A.G.G.; Postma, M.J.; Vegter, S.

2011-01-01

OBJECTIVES: Increasing real-life adherence to bisphosphonates therapy is important to achieve the clinical benefits of reducing fractures reported in randomized clinical trials (RCTs). The aim of this pharmacoeconomic analysis was to determine the cost-effectiveness of a pharmaceutical care

Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

Science.gov (United States)

Santana, Maria J; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

2015-07-01

Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. Adult learning programs teaching clinicians

Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

Science.gov (United States)

Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

2016-04-01

The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

Evolution of the clinical review station for enterprise-wide multimedia radiology reporting

Science.gov (United States)

Hanlon, William B.; Valtchinov, Vladimir I.; Davis, Scott D.; Lester, James; Khorasani, Ramin; Carrino, John A.; Benfield, Andrew

2000-05-01

Efforts to develop Picture Archiving and Communications Systems (PACS) for the last ten years have concentrated mainly on developing systems for primary interpretation of digital radiological images. Much less attention has been paid to the clinical aspects of the radiology process. Clinical radiology services are an important component of the overall care delivery process, providing information and consultation services to referring physicians, the customers of radiology, in a timely fashion to aid in care decisions. Information management systems (IMS) are playing an increasingly central role in the care delivery process. No suitable commercial PACS or IMS products were available that could effectively provide for the requirements of the clinicians. We endeavored to fill this void at our institution by developing a system to deliver images and text reports electronically on-demand to the referring physicians. This system has evolved substantially since initial deployment eight years ago. As new technologies become available they are evaluated and integrated as appropriate to improve system performance and manageability. Not surprisingly, the internet and World Wide Web (WWW) technology has had the greatest impact on system design in recent years. Additional features have been added over time to provide services for teleradiology, teaching, and research needs. We also discovered that these value-added services give us a competitive edge in attracting new business to our department. Commercial web-based products are now becoming available which do a satisfactory job of providing many of these clinical services. These products are evaluated for integration into our system as they mature. The result is a system that impacts positively on patient care.

Implant-supported titanium prostheses following augmentation procedures: a clinical report.

Science.gov (United States)

Knabe, C; Hoffmeister, B

2003-03-01

This report describes a novel technique for fabricating retrievable implant-supported titanium (Ti) prostheses in patients requiring a comprehensive treatment plan involving the combined efforts of maxillofacial surgery and implant prosthodontics. Following bone graft reconstructive surgery and implant placement prosthetic treatment was initiated by inserting ITI-Octa abutments. An impression was made, and a framework was fabricated by fusing Ti-cast frameworks to prefabricated titanium copings by laser-welding. This was followed by veneering or fabrication of a removable denture with Ti metal re-enforcement. Favourable clinical results have been achieved using these screw-retained Ti implant-supported restorations for patients treated with reconstructive bone graft-surgery, with clinical observation periods ranging from three to four years. The present observations suggest that these screw-retained implant-supported Ti prostheses may be a meaningful contribution to implant prosthodontics, facilitating retrievable restorations of optimum biocompatibility, good marginal precision and with a good esthetic result. However, controlled clinical studies are needed to establish the long-term serviceability of these Ti restorations.

Increasing the efficiency of autopsy reporting.

Science.gov (United States)

Siebert, Joseph R

2009-12-01

-When autopsy reports are delayed, clinicians and families do not receive information in a timely fashion. -Using lean principles derived from the Toyota Production System, we set out to streamline our autopsy reporting process. -In a formal workshop setting, we identified the steps involved in producing an autopsy report, then sought to eliminate, abbreviate, or reschedule them into a more efficient format. We established intermediate deadlines for each case, taking care to make them visible; we initiated a weekly quality assurance review, giving attention to both scientific issues and approaching deadlines. -By adopting a more standardized approach, eliminating redundancy, and improving the visibility of tasks, we improved the mean completion time of autopsy reports from 53 days (N = 47 cases) to 25 days (N = 47 cases). Previously, 17% of reports were completed by 30 days and 71% by 60 days; in the 15 months following initiation of the program, 72% of reports were completed by 30 days and 100% by 60 days. A follow-up survey of attending physicians revealed continuing appreciation for the autopsy and timely communication, with no perceived diminution in the quality of reports. -This approach was of great benefit in our laboratory and may assist others in reducing the turnaround time of their autopsy reports. It may also benefit other areas of the laboratory.

Evaluation of increased milking frequency as an additional treatment for cows with clinical mastitis.

Science.gov (United States)

Krömker, Volker; Zinke, Claudia; Paduch, Jan-Hendrik; Klocke, Doris; Reimann, Anette; Eller, Georg

2010-02-01

This field study focused on the possible effects of increased milking frequency (milking four times a day in comparison with milking twice a day) on clinical and bacteriological cure rates of clinical, antibiotically treated mastitis cases. Parameters tested were clinical, microbiological and full (cytomicrobiological) cure as well as the development of milk yield after the clinical mastitis episode. Cows from a large dairy herd meeting the study criteria (n=93) were assigned to two treatment groups by a systematic randomization scheme (blocked by body temperature 39.5 degrees C). Both groups were randomly divided by experimental treatments: a) antibiotic intramammary treatment and milking 2-times a day; b) antibiotic intramammary treatment and milking 4-times a day. Treatments were initiated before the culture results were known. Cows were surveyed and evaluated on days 1-6, 24 and 31. No significant differences between treatment and control groups regarding clinical cure, microbiological cure, full cure and milk production could be established. Applying a 4-times a day milking regime did not lead to any significant effect, either positive or negative. Therefore, the results suggest that milking 4-times a day as a supporting therapy for mild, moderate and severe antimicrobially treated mastitis cases cannot be recommended.

Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine

DEFF Research Database (Denmark)

Liu, Jian-Ping; Han, Mei; Li, Xin-Xue

2013-01-01

Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.......Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications....

Varenicline in Autism: Theory and Case Report of Clinical and Biochemical Changes.

Science.gov (United States)

Mostafavi, Mojdeh; Hardy, Paul; Arnold, L Eugene

2016-11-01

To explore the potential benefits of varenicline (CHANTIX ® ), a highly specific partial agonist of neuronal α4β2 nicotinic acetylcholine receptors (nAChR), for autistic symptoms, and present resulting biochemical changes in light of dopamine-related genotype. The clinical and biochemical changes exhibited by a 19-year-old severely autistic man following the use of low-dose varenicline in an ABA experiment of nature, and his genotype, were extracted from chart review. Clinical outcome was measured by the Ohio Autism Clinical Impression Scale and 12 relevant urine and saliva metabolites were measured by Neuroscience Laboratory. With varenicline, this patient improved clinically and autonomic biochemical indicators in saliva and urine normalized, including dopamine, 3,4-dihydroxyphenylacetic acid (DOPAC), epinephrine, norepinephrine, taurine, and histamine levels. In addition, with varenicline, the dopamine D1 receptor (DRD1) antibody titer as well as the percent of baseline calmodulin-dependent protein kinase II (CaM KII) activity dropped significantly. When varenicline stopped, he deteriorated; when it was resumed, he again improved. Doses of 0.5, 1, and 2 mg daily were tried before settling on a dose of 1.5 mg daily. He has remained on varenicline for over a year with no noticeable side effects. This report is, to the best of our knowledge, only the second to demonstrate positive effects of varenicline in autism, the first to show it in a severe case, and the first to show normalization of biochemical parameters related to genotype. As with the previous report, these encouraging results warrant further controlled research before clinical recommendations can be made.

Management of cannabis-induced periodontitis via resective surgical therapy: A clinical report.

Science.gov (United States)

Momen-Heravi, Fatemeh; Kang, Philip

2017-03-01

There is a lack of clinical research on the potential effect of cannabis use on the periodontium as well as its effect on treatment outcomes. The aim of this case report is to illustrate the clinical presentation of periodontal disease in a young woman who was a chronic cannabis user, as well as successful treatment involving motivating the patient to quit cannabis use and undergo nonsurgical and surgical therapy. A 23-year-old woman sought care at the dental clinic for periodontal treatment. During a review of her medical history, the patient reported using cannabis frequently during a 3-year period, which coincided with the occurrence of gingival inflammation. She used cannabis in the form of cigarettes that were placed at the mandibular anterior region of her mouth for prolonged periods. Localized prominent papillary and marginal gingival enlargement of the anterior mandible were present. The mandibular anterior teeth showed localized severe chronic periodontitis. The clinicians informed the patient about the potentially detrimental consequences of continued cannabis use; she was encouraged to quit, which she did. The clinicians performed nonsurgical therapy (scaling and root planing) and osseous surgery. The treatment outcome was evaluated over 6 months; improved radiographic and clinical results were observed throughout the follow-up period. Substantial availability and usage of cannabis, specifically among young adults, requires dentists to be vigilant about clinical indications of cannabis use and to provide appropriate treatments. Behavioral modification, nonsurgical therapy, and surgical therapy offer the potential for successful management of cannabis-related periodontitis. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment

National Research Council Canada - National Science Library

Kaplan, Celia P

2007-01-01

.... While inroads to increasing minority inclusion in breast cancer clinical trials have been made, recent reports continue to demonstrate lower enrollment among African Americans, Asian Americans...

Clinical research on peri-implant diseases: consensus report of Working Group 4.

LENUS (Irish Health Repository)

Sanz, Mariano

2012-02-01

Two systematic reviews have evaluated the quality of research and reporting of observational studies investigating the prevalence of, the incidence of and the risk factors for peri-implant diseases and of experimental clinical studies evaluating the efficacy of preventive and therapeutic interventions.

Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

Science.gov (United States)

Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein

2017-12-01

Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings  across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112)  = .15, p = .699), CRF length (F (2,112)  = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was

General practitioner's reported use of clinical guidelines for hypertension and ambulatory blood pressure.

LENUS (Irish Health Repository)

Flynn, E

2012-03-01

ABPM is an invaluable clinical tool, as it has been shown to improve blood pressure control in primary care. Many clinical guidelines for hypertension advocate ambulatory blood pressure monitoring. This study aims to quantify the use of clinical guidelines for hypertension and to explore the role of ABPM in Primary Care. A questionnaire survey was sent to GPs working in the West of Ireland. 88% (n=139) of GPs use clinical guidelines that recommend the use of ABPM. 82% (n=130) of GPs find use of clinic blood pressure monitoring insufficient for the diagnosis and monitoring of hypertension. Despite good access to ABPM, GPs report lack of remuneration, 72% (n=116), cost 68% (n=108), and lack of time, 51% (n=83) as the main limiting factors to use of ABPM. GPs recognise the clinical value of ABPM, but this study identifies definite barriers to the use of ABPM in Primary Care.

Pharmacogenetics Informed Decision Making in Adolescent Psychiatric Treatment: A Clinical Case Report

Directory of Open Access Journals (Sweden)

Teri Smith

2015-02-01

Full Text Available Advances made in genetic testing and tools applied to pharmacogenetics are increasingly being used to inform clinicians in fields such as oncology, hematology, diabetes (endocrinology, cardiology and expanding into psychiatry by examining the influences of genetics on drug efficacy and metabolism. We present a clinical case example of an adolescent male with anxiety, attention deficit hyperactivity disorder (ADHD and autism spectrum disorder who did not tolerate numerous medications and dosages over several years in attempts to manage his symptoms. Pharmacogenetics testing was performed and DNA results on this individual elucidated the potential pitfalls in medication use because of specific pharmacodynamic and pharmacokinetic differences specifically involving polymorphisms of genes in the cytochrome p450 enzyme system. Future studies and reports are needed to further illustrate and determine the type of individualized medicine approach required to treat individuals based on their specific gene patterns. Growing evidence supports this biological approach for standard of care in psychiatry.

Clinical research in implant dentistry: evaluation of implant-supported restorations, aesthetic and patient-reported outcomes.

Science.gov (United States)

Lang, Niklaus P; Zitzmann, Nicola U

2012-02-01

The articles discussed in working group 3 dealt with specific aspects of clinical research. In this context, the literature reporting on survival and complication rates of implant-supported or implant-tooth supported restorations in longitudinal studies of at least 5 years were discussed. The second aspect dealt with the evaluation of aesthetic outcomes in clinical studies and the related index systems available. Finally, the third aspect discussed dealt with patient-reported outcome measures (PROMs). A detailed appraisal of the available methodology was presented. © 2012 John Wiley & Sons A/S.

Routine reporting of estimated glomerular filtration rate (eGFR) in African laboratories and the need for its increased utilisation in clinical practice.

Science.gov (United States)

Adebisi, Simeon A

2013-03-01

Chronic Kidney Disease (CKD) is defined as the presence of markers of kidney damage or of estimated glomerular filtration rate (eGFR)clinical practice. Current guidelines advocate the use of prediction equations, such as the Cockcroft-Gault (CG) formula and the Modification of Diet in Renal Disease (MDRD) study-derived equations. Laboratories in African should commence routine reporting of eGFR for a number of reasons; 1. The sensitivity of serum creatinine (Scr) in identifying CKD is low.2. In Nigeria, a representative country; screening for Chronic Kidney Disease (CKD) is hardly considered in the routine practice of the primary and secondary care medical officers.3 Studies have shown that routine reporting of eGFR improved the documentation and identification of CKD by almost 50%.4 There is the possibility of reversing CKD if picked earlier.5. The high cost of treating CKD patients in advanced stages and the low per capital income status of the populace in Sub-Saharan Africa.6. Poor health infrastructure to manage advanced CKD patients in the continent.7. Several studies, now show lack of awareness of CKD among non-nephrologists that is related, at least in part, to difficulty in interpreting serum creatinine concentrations (the reciprocal, non-linear relationship between GFR and serum creatinine).8 Mathematical estimates of GFR [ as in eGFR] that incorporate creatinine concentration, as well as factors affecting creatinine production rates, such as size, gender, age and ethnic background, are more sensitive to changes in renal function than serum creatinine value alone.9 Recent guidelines define "action plans" for CKD according to the GFR, including referral to nephrologists at GFRs<30 mL.min(-1).(1.73 m2).

The relationship between carers' report of autistic traits and clinical diagnoses of autism spectrum disorders in adults with intellectual disability.

Science.gov (United States)

Bhaumik, Sabyasachi; Tyrer, Freya; Barrett, Mary; Tin, Nyunt; McGrother, Catherine W; Kiani, Reza

2010-01-01

It is often difficult to determine the triad of impairments and whether autistic features are the consequence of intellectual impairment or autism spectrum disorders in people with intellectual disability (ID). The aim of the current study was to investigate the relationship between carer-reported autistic traits and independent diagnoses of autism spectrum disorders (ASD). Data were collected on carers' subjective report of autistic traits and clinical diagnoses of ASD. Of 1145 adults with ID identified, 220 (19%) individuals had a diagnosis of ASD, and 778 (68%) individuals had at least one autistic trait. Optimal sensitivity and specificity were achieved with two or more autistic traits (sensitivity 63%; specificity 79%) and the positive predictive value increased substantially as the number of autistic traits increased. However, a significant proportion of individuals with ID who did not have a diagnosis of ASD also displayed autistic traits. Our findings suggest that in the absence of other measures, the presence of autistic traits can serve as a useful proxy measure for ASD in research (and/or clinical settings). However, although information on autistic traits may help healthcare practitioners to identify people with possible ASD, it cannot be used alone to make a formal diagnosis. 2010 Elsevier Ltd. All rights reserved.

Increasing Cervical Cancer Screening Coverage: A Randomised, Community-Based Clinical Trial.

Directory of Open Access Journals (Sweden)

Amelia Acera

Full Text Available Opportunistic cervical cancer screening can lead to suboptimal screening coverage. Coverage could be increased after a personalised invitation to the target population. We present a community randomized intervention study with three strategies aiming to increase screening coverage.The CRICERVA study is a community-based clinical trial to improve coverage of population-based screening in the Cerdanyola SAP area in Barcelona.A total of 32,858 women residing in the study area, aged 30 to 70 years were evaluated. A total of 15,965 women were identified as having no registration of a cervical cytology in the last 3.5 years within the Public Health data base system. Eligible women were assigned to one of four community randomized intervention groups (IGs: (1 (IG1 N = 4197 personalised invitation letter, (2 (IG2 N = 3601 personalised invitation letter + informative leaflet, (3 (IG3 N = 6088 personalised invitation letter + informative leaflet + personalised phone call and (4 (Control N = 2079 based on spontaneous demand of cervical cancer screening as officially recommended. To evaluate screening coverage, we used heterogeneity tests to compare impact of the interventions and mixed logistic regression models to assess the age effect. We refer a "rescue" visit as the screening visit resulting from the study invitation.Among the 13,886 women in the IGs, 2,862 were evaluated as having an adequate screening history after the initial contact; 4,263 were lost to follow-up and 5,341 were identified as having insufficient screening and thus being eligible for a rescue visit. All intervention strategies significantly increased participation to screening compared to the control group. Coverage after the intervention reached 84.1% while the control group reached 64.8%. The final impact of our study was an increase of 20% in the three IGs and of 9% in the control group (p<0.001. Within the intervention arms, age was an important determinant of rescue visits

Student-generated case reports.

Science.gov (United States)

Good, Christopher J

2009-01-01

When students create teaching materials, learning can be enhanced. Therefore, a project was designed based on the traditional clinical case report and the chiropractic technique and principles curriculum at the University of Bridgeport College of Chiropractic. The objectives were to increase mastery in a clinical topic, increase awareness of different patient presentations and management options, and enhance information technology skills. Following lectures about the components of a case report and neurological reflexes related to visceral comorbidities and subluxation and joint dysfunction, students created a case report based on a template provided by the instructor. A survey gathered student perspectives on the exercise. More than 70% of the surveyed students felt the project was at least moderately helpful in improving understanding of a case report, the condition investigated, their clinical reasoning, and the ability to integrate information. Most felt that they improved their understanding of neurological reflexes, use of the literature, and the practice of evidence-based care. The majority believed that they identified weakness in knowledge, improved self-learning skills, and increased confidence in managing patients. Most enjoyed it at least somewhat and 70% agreed that the project should be continued. Many believed that they were better prepared for national boards and had improved their writing skills.

Added Value of Patient-Reported Outcome Measures in Stroke Clinical Practice.

Science.gov (United States)

Katzan, Irene L; Thompson, Nicolas R; Lapin, Brittany; Uchino, Ken

2017-07-21

There is uncertainty regarding the clinical utility of the data obtained from patient-reported outcome measures (PROMs) for patient care. We evaluated the incremental information obtained by PROMs compared to the clinician-reported modified Rankin Scale (mRS). This was an observational study of 3283 ischemic stroke patients seen in a cerebrovascular clinic from September 14, 2012 to June 16, 2015 who completed the routinely collected PROMs: Stroke Impact Scale-16 (SIS-16), EQ-5D, Patient Health Questionnaire-9, PROMIS Physical Function, and PROMIS fatigue. The amount of variation in the PROMs explained by mRS was determined using r 2 after adjustment for age and level of stroke impairment. The proportion with meaningful change was calculated for patients with ≥2 visits. Concordance with change in the other scales and the ability to discriminate changes in health state as measured by c-statistic was evaluated for mRS versus SIS-16. Correlation between PROMs and mRS was highest for SIS-16 ( r =-0.64, P measures. PROMs provide additional valuable information compared to the mRS alone in stroke patients seen in the ambulatory setting. SIS-16 may have a better ability to identify change than mRS in health status of relevance to the patient. PROMs may be a useful addition to mRS in the assessment of health status in clinical practice. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO).

Science.gov (United States)

de Souza, Raphael Freitas; Chaves, Carolina de Andrade Lima; Nasser, Mona; Fedorowicz, Zbys

2010-01-01

Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-to-treat analysis had been carried out. The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-to-treat analysis or any similar procedure. The results of this study indicate that a substantial number of reports of trials and systematic

Pattern of breast diseases: preliminary report of breast clinic

International Nuclear Information System (INIS)

Siddiqui, K.; Rasool, I.

2001-01-01

programme, the number of patients attending the breast clinic increased from 13% in Ist quarter 23.8% in the last quarter of the study. (author)

Increased risk of coronary heart disease among individuals reporting adverse impact of stress on their health: the Whitehall II prospective cohort study.

Science.gov (United States)

Nabi, Hermann; Kivimäki, Mika; Batty, G David; Shipley, Martin J; Britton, Annie; Brunner, Eric J; Vahtera, Jussi; Lemogne, Cédric; Elbaz, Alexis; Singh-Manoux, Archana

2013-09-01

Response to stress can vary greatly between individuals. However, it remains unknown whether perceived impact of stress on health is associated with adverse health outcomes. We examined whether individuals who report that stress adversely affects their health are at increased risk of coronary heart disease (CHD) compared with those who report that stress has no adverse health impact. Analyses are based on 7268 men and women (mean age: 49.5 years, interquartile range: 11 years) from the British Whitehall II cohort study. Over 18 years of follow-up, there were 352 coronary deaths or first non-fatal myocardial infarction (MI) events. After adjustment for sociodemographic characteristics, participants who reported at baseline that stress has affected their health 'a lot or extremely' had a 2.12 times higher (95% CI 1.52-2.98) risk of coronary death or incident non-fatal MI when compared with those who reported no effect of stress on their health. This association was attenuated but remained statistically significant after adjustment for biological, behavioural, and other psychological risk factors including perceived stress levels, and measures of social support; fully adjusted hazard ratio: 1.49 (95% CI 1.01-2.22). In this prospective cohort study, the perception that stress affects health, different from perceived stress levels, was associated with an increased risk of coronary heart disease. Randomized controlled trials are needed to determine whether disease risk can be reduced by increasing clinical attention to those who complain that stress greatly affects their health.

Report of the consultants' meeting on radioimmunometric assays for non-clinical applications

International Nuclear Information System (INIS)

2000-01-01

A meeting between three experts and various Agency staff with specific areas of expertise was convened to review present status of radiolabelled immunoassays i.e. radioimmunoassay (RIA) and immunradiometric assay (IRMA) and their relevance to non- clinical applications. For many years, the Agency has been active in supporting the devolution of RIA and IRMA expertise in clinical applications, particularly in the field of thyroid disease and its management. The Agency's strategy was based on a perceived need to reduce the high cost of imported reagents and the poor working practices that this encouraged. This has been achieved through the use of bulk reagents (rather than 'kits') and the transfer of existing technology. The success of the Agency's approach is evident from the high degree of self- sufficiency now available in many developing countries. In recent years, the increasing workload for clinical analyses has necessitated an increase in automation, which in turn has required a change to more non-isotopic alternatives. This change seen in the more developed countries, and beginning to be introduced elsewhere, is likely lo continue. However, RIA/IRMA will continue to be used in many parts of the world for some time to come. In recent years there has been an increasing interest in the use of immunoassay technology in non-clinical applications, e.g., environmental monitoring, quality control in food production and livestock management. RIA and IRMA continue to play a major role in research

Sildenafil (Viagra for male erectile dysfunction: a meta-analysis of clinical trial reports

Directory of Open Access Journals (Sweden)

McQuay HJ

2002-05-01

Full Text Available Abstract Background Evaluation of company clinical trial reports could provide information for meta-analysis at the commercial introduction of a new technology. Methods Clinical trial reports of sildenafil for erectile dysfunction from September 1997 were used for meta-analysis of randomised trials (at least four weeks duration and using fixed or dose optimisation regimens. The main outcome sought was an erection, sufficiently rigid for penetration, followed by successful intercourse, and conducted at home. Results Ten randomised controlled trials fulfilled the inclusion criteria (2123 men given sildenafil and 1131 placebo. NNT or NNH were calculated for important efficacy, adverse event and discontinuation outcomes. Dose optimisation led to at least 60% of attempts at sexual intercourse being successful in 49% of men, compared with 11% with placebo; the NNT was 2.7 (95% confidence interval 2.3 to 3.3. For global improvement in erections the NNT was 1.7 (1.6 to 1.9. Treatment-related adverse events occurred in 30% of men on dose optimised sildenafil compared with 11% on placebo; the NNH was 5.4 (4.3 to 7.3. All cause discontinuations were less frequent with sildenafil (10% than with placebo (20%. Sildenafil dose optimisation gave efficacy equivalent to the highest fixed doses, and adverse events equivalent to the lowest fixed doses. Conclusion This review of clinical trial reports available at the time of licensing agreed with later reviews that had many more trials and patients. Making reports submitted for marketing approval available publicly would provide better information when it was most needed, and would improve evidence-based introduction of new technologies.

Characteristics of Patients Who Report Confusion After Reading Their Primary Care Clinic Notes Online.

Science.gov (United States)

Root, Joseph; Oster, Natalia V; Jackson, Sara L; Mejilla, Roanne; Walker, Jan; Elmore, Joann G

2016-01-01

Patient access to online electronic medical records (EMRs) is increasing and may offer benefits to patients. However, the inherent complexity of medicine may cause confusion. We elucidate characteristics and health behaviors of patients who report confusion after reading their doctors' notes online. We analyzed data from 4,528 patients in Boston, MA, central Pennsylvania, and Seattle, WA, who were granted online access to their primary care doctors' clinic notes and who viewed at least one note during the 1-year intervention. Three percent of patients reported confusion after reading their visit notes. These patients were more likely to be at least 70 years of age (p education (p reading visit notes (relative risk [RR] 4.83; confidence interval [CI] 3.17, 7.36) compared to patients who were not confused. In adjusted analyses, they were less likely to report feeling more in control of their health (RR 0.42; CI 0.25, 0.71), remembering their care plan (RR 0.26; CI 0.17, 0.42), and understanding their medical conditions (RR 0.32; CI 0.19, 0.54) as a result of reading their doctors' notes compared to patients who were not confused. Patients who were confused by reading their doctors' notes were less likely to report benefits in health behaviors. Understanding this small subset of patients is a critical step in reducing gaps in provider-patient communication and in efforts to tailor educational approaches for patients.

Aarskog-Scott syndrome: clinical update and report of nine novel mutations of the FGD1 gene.

Science.gov (United States)

Orrico, A; Galli, L; Faivre, L; Clayton-Smith, J; Azzarello-Burri, S M; Hertz, J M; Jacquemont, S; Taurisano, R; Arroyo Carrera, I; Tarantino, E; Devriendt, K; Melis, D; Thelle, T; Meinhardt, U; Sorrentino, V

2010-02-01

Mutations in the FGD1 gene have been shown to cause Aarskog-Scott syndrome (AAS), or facio-digito-genital dysplasia (OMIM#305400), an X-linked disorder characterized by distinctive genital and skeletal developmental abnormalities with a broad spectrum of clinical phenotypes. To date, 20 distinct mutations have been reported, but little phenotypic data are available on patients with molecularly confirmed AAS. In the present study, we report on our experience of screening for mutations in the FGD1 gene in a cohort of 60 European patients with a clinically suspected diagnosis of AAS. We identified nine novel mutations in 11 patients (detection rate of 18.33%), including three missense mutations (p.R402Q; p.S558W; p.K748E), four truncating mutations (p.Y530X; p.R656X; c.806delC; c.1620delC), one in-frame deletion (c.2020_2022delGAG) and the first reported splice site mutation (c.1935+3A>C). A recurrent mutation (p.R656X) was detected in three independent families. We did not find any evidence for phenotype-genotype correlations between type and position of mutations and clinical features. In addition to the well-established phenotypic features of AAS, other clinical features are also reported and discussed. Copyright 2010 Wiley-Liss, Inc.

International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium.

Science.gov (United States)

Harris, Andrew C; Young, Rachel; Devine, Steven; Hogan, William J; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L M; Levine, John E

2016-01-01

Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and nonrelapse mortality after allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed on by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multicenter clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance followed discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture, which may improve the reproducibility of GVHD clinical trials after further prospective validation. Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials

DEFF Research Database (Denmark)

Stamp, Lisa K; Morillon, Melanie B; Taylor, William J

2018-01-01

OBJECTIVE: To describe the ways in which serum urate (SU) and gout flares are reported in clinical trials, and to propose minimum reporting requirements. METHODS: This analysis was done as part of a systematic review aiming to validate SU as a biomarker for gout. The ways in which SU and flares.......3%) of these reporting at more than just the final study visit. Two ways of reporting gout flares were identified: mean flare rate and percentage of participants with flares. There was variability in time periods over which flares rates were reported. CONCLUSION: There is inconsistent reporting of SU and flares in gout...... studies. Reporting the percentage of participants who achieve a target SU reflects international treatment guidelines. SU should also be reported as a continuous variable with a relevant central and dispersion estimate. Gout flares should be reported as both percentage of participants and mean flare rates...

Focus: Increasing profitability from powerful assets. Annual report for 1998

International Nuclear Information System (INIS)

1999-01-01

Report on operations at the end of fiscal year 1998 and on the year-end financial position of PanCanadian Petroleum Limited is provided. By all accounts the company had a successful year: increased production by seven percent to 796 mmcf/day, making the company the largest publicly traded gas producer in Canada; ranked as one of lowest-cost producers in western Canada with average operating costs of $ 0.37/mcf; drilled 1,081 new wells at a success rate of 85 per cent and increased royalty interest production five per cent to an average of 26,700 barrels of oil equivalent per day. Other achievements included drilling in Nova Scotia, land and license aquisition in the Gulf of Mexico and in the North Sea respectively, acquisition of a 15 per cent interest in two exploration blocks off the Ivory Coast in West Africa, refining of proprietory seismic technologies developed in recent years, reduction of average well costs by 10 per cent by using new drill bit technology, consolidation of Canadian and American natural gas marketing groups to increase market access across North America, and management reorganization of the Heavy Oil Business Unit. In addition to details of these and other achievements, the report also contains management analysis of key business results, the consolidated financial statements and various operating and financial statistics and results

Case reports and clinical guidelines for managing radix entomolaris

Directory of Open Access Journals (Sweden)

Bejoy J Thomas

2016-01-01

Full Text Available Knowledge about the external and internal anatomy of the tooth is essential for successful dental practice. Anomalies in the tooth are often encountered which poses difficulties in dental treatments. As like any other tooth, mandibular first molars are also prone for anatomic malformations. One such anatomic variation is the presence of extra root distolingually. This distolingual root is called radix entomolaris (RE. The presence of an additional root can lead to difficulties during endodontic therapy. This article is a report of two cases describing the management of the first mandibular molars with an RE and clinical guidelines for its management.

Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

Science.gov (United States)

Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

2016-09-27

Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. 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/

Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers.

Science.gov (United States)

Antunes, Bárbara; Harding, Richard; Higginson, Irene J

2014-02-01

Many patient-reported outcome measures have been developed in the past two decades, playing an increasingly important role in palliative care. However, their routine use in practice has been slow and difficult to implement. To systematically identify facilitators and barriers to the implementation of patient-reported outcome measures in different palliative care settings for routine practice, and to generate evidence-based recommendations, to inform the implementation process in clinical practice. Systematic literature review and narrative synthesis. Medline, PsycInfo, Cumulative Index to Nursing and Allied Health Literature, Embase and British Nursing Index were systematically searched from 1985. Hand searching of reference lists for all included articles and relevant review articles was performed. A total of 3863 articles were screened. Of these, 31 articles met the inclusion criteria. First, data were integrated in the main themes: facilitators, barriers and lessons learned. Second, each main theme was grouped into either five or six categories. Finally, recommendations for implementation on outcome measures at management, health-care professional and patient levels were generated for three different points in time: preparation, implementation and assessment/improvement. Successful implementation of patient-reported outcome measures should be tailored by identifying and addressing potential barriers according to setting. Having a coordinator throughout the implementation process seems to be key. Ongoing cognitive and emotional processes of each individual should be taken into consideration during changes. The educational component prior to the implementation is crucial. This could promote ownership and correct use of the measure by clinicians, potentially improving practice and the quality of care provided through patient-reported outcome measure data use in clinical decision-making.

Perceptions and Attitudes towards Medication Error Reporting in Primary Care Clinics: A Qualitative Study in Malaysia.

Science.gov (United States)

Samsiah, A; Othman, Noordin; Jamshed, Shazia; Hassali, Mohamed Azmi

2016-01-01

To explore and understand participants' perceptions and attitudes towards the reporting of medication errors (MEs). A qualitative study using in-depth interviews of 31 healthcare practitioners from nine publicly funded, primary care clinics in three states in peninsular Malaysia was conducted for this study. The participants included family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. The interviews were audiotaped and transcribed verbatim. Analysis of the data was guided by the framework approach. Six themes and 28 codes were identified. Despite the availability of a reporting system, most of the participants agreed that MEs were underreported. The nature of the error plays an important role in determining the reporting. The reporting system, organisational factors, provider factors, reporter's burden and benefit of reporting also were identified. Healthcare practitioners in primary care clinics understood the importance of reporting MEs to improve patient safety. Their perceptions and attitudes towards reporting of MEs were influenced by many factors which affect the decision-making process of whether or not to report. Although the process is complex, it primarily is determined by the severity of the outcome of the errors. The participants voluntarily report the errors if they are familiar with the reporting system, what error to report, when to report and what form to use.

Reorganizing the General Clinical Research Center to improve the clinical and translational research enterprise.

Science.gov (United States)

Allen, David; Ripley, Elizabeth; Coe, Antoinette; Clore, John

2013-12-01

In 2010, Virginia Commonwealth University (VCU) was granted a Clinical and Translational Science Award which prompted reorganization and expansion of their clinical research infrastructure. A case study approach is used to describe the implementation of a business and cost recovery model for clinical and translational research and the transformation of VCU's General Clinical Research Center and Clinical Trials Office to a combined Clinical Research Services entity. We outline the use of a Plan, Do, Study, Act cycle that facilitated a thoughtful transition process, which included the identification of required changes and cost recovery processes for implementation. Through this process, the VCU Center for Clinical and Translational Research improved efficiency, increased revenue recovered, reduced costs, and brought a high level of fiscal responsibility through financial reporting.

Increasing transparency in the European Union: developments of Country-by-Country Reporting

Directory of Open Access Journals (Sweden)

Alicja Brodzka

2017-09-01

Full Text Available Increasing transparency in the European Union: developments of Country-by-Country Reporting The aim of the paper is to bring closer Country-by-Country Reporting and outline possible future amendments of the introduced anti-tax avoidance measures. The article presents the motives of implementing the international CbC initiative, aimed at increasing transparency of the biggest multinational enterprises, with particular emphasis on the specificity of the European Union. Part 2 of the paper analyses the Euro-pean legal bases for companies’ financial reporting. It also gives an overview of the main findings of Directive 2016/881, which implements Country-by-Country Reporting and allows for the exchange of information between tax authorities. Part 3 deals with the national perspective, presenting the CbC solu-tions implemented to the Polish legal system; the paper also attempts to assess the potential impact of tax information disclosures, both from the perspective of taxpayers and the tax administration. The final part presents conclusions and tries to draft future developments of the Country-by-Country Reporting system. In the paper, the following research methods have been used: critical analysis and deduction, with partic-ular reference to the source materials and legal acts, as well as the reports of the European Commission, consulting companies, and NGOs. Although the article deals with tax matters, CbC Reporting is an im-portant and relevant issue from the point of view of researchers and accounting specialists. Reporting this phenomenon is part of the accounting science as a universal tool for recording economic phenomena. The author examined all relevant sources and took into account all important factors in order to obtain a com-prehensive picture of CbC Reporting and to prepare a paper that may serve as a reference for future research.

Chief medical clinic manager of a university OB/GYN clinic--an innovative job description as management response for increase of profitability, quality of care, and physicians' freedom of action.

Science.gov (United States)

Jacobs, Volker R; Mallmann, Peter

2010-01-01

Leadership structures in German clinics are adjusting parallel to DRG (diagnose-related groups)-induced economic reorientation of the health care system. A Chief Medical Clinic Manager (CMCM) is a new job description and an innovative approach to combine medical competence and business economics at the operational level of care. The ideal qualification is a medical specialist in the clinical field with practical experience in patient care and leadership as well as in hospital economics and quality control. A CMCM is placed at a superior level in the clinic, with authorizing competence for the entire physician team. Main tasks are cost transparency within the clinic, organizational development by structured processes, and financial and strategic controlling of all business aspects. A CMCM induces change management and financial adjustment of care to reimbursement with maintaining the standard of care. In cooperation with the director of the clinic, a CMCM develops a vision for clinic development, an investment strategy, and a business plan. The success parameters are positive operative results of the clinic, cost-covering care, increased investment rate, employee satisfaction, and implementation of innovations in research and therapy. A CMCM thereby increases financial and organizational freedom of action at the clinic level in a non-profit public health care system.

Patterns of presentation and clinical features of toxicity after reported use of ([2-aminopropyl]-2,3-dihydrobenzofurans), the 'benzofuran' compounds. A report from the United Kingdom National Poisons Information Service.

Science.gov (United States)

Kamour, Ashraf; James, David; Lupton, David J; Cooper, Gillian; Eddleston, Micheal; Vale, Allister; Thompson, John P; Thanacoody, Ruben; Hill, Simon L; Thomas, Simon H L

2014-12-01

To characterise the patterns of presentation and clinical features of toxicity following reported recreational use of benzofuran compounds ((2-aminopropyl)-2,3-dihydrobenzofurans) in the UK, as reported to the National Poisons Information Service (NPIS), and to compare clinical features of toxicity with those after reported mephedrone use. NPIS patient-specific telephone enquiries and user sessions for TOXBASE(®), the NPIS online information database, related to (2-aminopropyl)-2,3-dihydrobenzofurans and associated synonyms were reviewed from March 2009 to August 2013. These data were compared with those of mephedrone, the recreational substance most frequently reported to NPIS, collected over the same period. There were 63 telephone enquiries concerning 66 patients and 806 TOXBASE(®) user sessions regarding benzofuran compounds during the period of study. The first telephone enquiry was made in July 2010 and the highest numbers of enquiries were received in August 2010 (33 calls, 112 TOXBASE(®) sessions). Patients were predominantly male (82%) with a median age of 29 years; 9 reported co-ingestion of other substances. Comparing the 57 patients who reported ingesting benzofuran compounds alone with 315 patients ingesting mephedrone alone, benzofurans were more often associated with stimulant features, including tachycardia, hypertension, mydriasis, palpitation, fever, increased sweating, and tremor, (72% vs. 38%, odds ratio [OR] 4.2, 95% confidence interval [CI] 2.27-7.85, P < 0.0001) and mental health disturbances (58% vs. 38%, OR 2.3, 95% CI 1.29-4.07, P = 0.006). Other features reported after benzofuran compound ingestion included gastrointestinal symptoms (16%), reduced level of consciousness (9%), chest pain (7%), and creatinine kinase elevation (5%). Reported ingestion of benzofuran compounds is associated with similar toxic effects to those of amphetamines and cathinones. Mental health disturbances and stimulant features were reported more frequently

Reporting the results of meta-analyses: a plea for incorporating clinical relevance referring to an example.

Science.gov (United States)

Bartels, Ronald H M A; Donk, Roland D; Verhagen, Wim I M; Hosman, Allard J F; Verbeek, André L M

2017-11-01

The results of meta-analyses are frequently reported, but understanding and interpreting them is difficult for both clinicians and patients. Statistical significances are presented without referring to values that imply clinical relevance. This study aimed to use the minimal clinically important difference (MCID) to rate the clinical relevance of a meta-analysis. This study is a review of the literature. This study is a review of meta-analyses relating to a specific topic, clinical results of cervical arthroplasty. The outcome measure used in the study was the MCID. We performed an extensive literature search of a series of meta-analyses evaluating a similar subject as an example. We searched in Pubmed and Embase through August 9, 2016, and found articles concerning meta-analyses of the clinical outcome of cervical arthroplasty compared with that of anterior cervical discectomy with fusion in cases of cervical degenerative disease. We evaluated the analyses for statistical significance and their relation to MCID. MCID was defined based on results in similar patient groups and a similar disease entity reported in the literature. We identified 21 meta-analyses, only one of which referred to MCID. However, the researchers used an inappropriate measurement scale and, therefore, an incorrect MCID. The majority of the conclusions were based on statistical results without mentioning clinical relevance. The majority of the articles we reviewed drew conclusions based on statistical differences instead of clinical relevance. We recommend introducing the concept of MCID while reporting the results of a meta-analysis, as well as mentioning the explicit scale of the analyzed measurement. Copyright © 2017 Elsevier Inc. All rights reserved.

Correlation between self-reported and clinically based diagnoses of bruxism in temporomandibular disorders patients.

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Paesani, D A; Lobbezoo, F; Gelos, C; Guarda-Nardini, L; Ahlberg, J; Manfredini, D

2013-11-01

The present investigation was performed in a population of patients with temporomandibular disorders (TMD), and it was designed to assess the correlation between self-reported questionnaire-based bruxism diagnosis and a diagnosis based on history taking plus clinical examination. One-hundred-fifty-nine patients with TMD underwent an assessment including a questionnaire investigating five bruxism-related items (i.e. sleep grinding, sleep grinding referral by bed partner, sleep clenching, awake clenching, awake grinding) and an interview (i.e. oral history taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism signs and symptoms. The correlation between findings of the questionnaire, viz., patients' report, and findings of the interview/oral history taking plus clinical examination, viz., clinicians' diagnosis, was assessed by means of φ coefficient. The highest correlations were achieved for the sleep grinding referral item (φ = 0·932) and for the awake clenching item (φ = 0·811), whilst lower correlation values were found for the other items (φ values ranging from 0·363 to 0·641). The percentage of disagreement between the two diagnostic approaches ranged between 1·8% and 18·2%. Within the limits of the present investigation, it can be suggested that a strong positive correlation between a self-reported and a clinically based approach to bruxism diagnosis can be achieved as for awake clenching, whilst lower levels of correlation were detected for sleep-time activities. © 2013 John Wiley & Sons Ltd.

Increasing referral of at-risk travelers to travel health clinics: evaluation of a health promotion intervention targeted to travel agents.

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MacDougall, L A; Gyorkos, T W; Leffondré, K; Abrahamowicz, M; Tessier, D; Ward, B J; MacLean, J D

2001-01-01

Increases in travel-related illness require new partnerships to ensure travelers are prepared for health risks abroad. The travel agent is one such partner and efforts to encourage travel agents to refer at-risk travelers to travel health clinics may help in reducing travel-attributable morbidity. A health promotion intervention encouraging travel agents to refer at-risk travelers to travel health clinics was evaluated. Information on the knowledge, attitudes, and behaviors of travel agents before and after the intervention was compared using two self-administered questionnaires. The Wilcoxon signed rank test was used to compare the mean difference in overall scores to evaluate the overall impact of the intervention and also subscores for each of the behavioral construct groupings (attitudes, barriers, intent, and subjective norms). Multiple regression techniques were used to evaluate which travel agent characteristics were independently associated with a stronger effect of the intervention. A small improvement in travel agents overall attitudes and beliefs (p =.03) was found, in particular their intention to refer (p =.01). Sixty-five percent of travel agents self-reported an increase in referral behavior; owners or managers of the agency were significantly more likely to do so than other travel agents (OR = 7.25; 95% CI: 1.64 32.06). Older travel agents, those that worked longer hours and those with some past referral experience, had significantly higher post-intervention scores. Travel agents can be willing partners in referral, and agencies should be encouraged to develop specific referral policies. Future research may be directed toward investigating the role of health education in certification curricula, the effectiveness of different types of health promotion interventions, including Internet-facilitated interventions, and the direct impact that such interventions would have on travelers attending travel health clinics.

Clinical data miner: an electronic case report form system with integrated data preprocessing and machine-learning libraries supporting clinical diagnostic model research.

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Installé, Arnaud Jf; Van den Bosch, Thierry; De Moor, Bart; Timmerman, Dirk

2014-10-20

Using machine-learning techniques, clinical diagnostic model research extracts diagnostic models from patient data. Traditionally, patient data are often collected using electronic Case Report Form (eCRF) systems, while mathematical software is used for analyzing these data using machine-learning techniques. Due to the lack of integration between eCRF systems and mathematical software, extracting diagnostic models is a complex, error-prone process. Moreover, due to the complexity of this process, it is usually only performed once, after a predetermined number of data points have been collected, without insight into the predictive performance of the resulting models. The objective of the study of Clinical Data Miner (CDM) software framework is to offer an eCRF system with integrated data preprocessing and machine-learning libraries, improving efficiency of the clinical diagnostic model research workflow, and to enable optimization of patient inclusion numbers through study performance monitoring. The CDM software framework was developed using a test-driven development (TDD) approach, to ensure high software quality. Architecturally, CDM's design is split over a number of modules, to ensure future extendability. The TDD approach has enabled us to deliver high software quality. CDM's eCRF Web interface is in active use by the studies of the International Endometrial Tumor Analysis consortium, with over 4000 enrolled patients, and more studies planned. Additionally, a derived user interface has been used in six separate interrater agreement studies. CDM's integrated data preprocessing and machine-learning libraries simplify some otherwise manual and error-prone steps in the clinical diagnostic model research workflow. Furthermore, CDM's libraries provide study coordinators with a method to monitor a study's predictive performance as patient inclusions increase. To our knowledge, CDM is the only eCRF system integrating data preprocessing and machine-learning libraries

Characterization of Change and Significance for Clinical Findings in Radiology Reports Through Natural Language Processing.

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Hassanpour, Saeed; Bay, Graham; Langlotz, Curtis P

2017-06-01

We built a natural language processing (NLP) method to automatically extract clinical findings in radiology reports and characterize their level of change and significance according to a radiology-specific information model. We utilized a combination of machine learning and rule-based approaches for this purpose. Our method is unique in capturing different features and levels of abstractions at surface, entity, and discourse levels in text analysis. This combination has enabled us to recognize the underlying semantics of radiology report narratives for this task. We evaluated our method on radiology reports from four major healthcare organizations. Our evaluation showed the efficacy of our method in highlighting important changes (accuracy 99.2%, precision 96.3%, recall 93.5%, and F1 score 94.7%) and identifying significant observations (accuracy 75.8%, precision 75.2%, recall 75.7%, and F1 score 75.3%) to characterize radiology reports. This method can help clinicians quickly understand the key observations in radiology reports and facilitate clinical decision support, review prioritization, and disease surveillance.

Detecting Ebola with limited laboratory access in the Democratic Republic of Congo: evaluation of a clinical passive surveillance reporting system.

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Ashbaugh, Hayley R; Kuang, Brandon; Gadoth, Adva; Alfonso, Vivian H; Mukadi, Patrick; Doshi, Reena H; Hoff, Nicole A; Sinai, Cyrus; Mossoko, Mathias; Kebela, Benoit Ilunga; Muyembe, Jean-Jacques; Wemakoy, Emile Okitolonda; Rimoin, Anne W

2017-09-01

Ebola virus disease (EVD) can be clinically severe and highly fatal, making surveillance efforts for early disease detection of paramount importance. In areas with limited access to laboratory testing, the Integrated Disease Surveillance and Response (IDSR) strategy in the Democratic Republic of Congo (DRC) may be a vital tool in improving outbreak response. Using DRC IDSR data from the nation's four EVD outbreak periods from 2007-2014, we assessed trends of Viral Hemorrhagic Fever (VHF) and EVD differential diagnoses reportable through IDSR. With official case counts from active surveillance of EVD outbreaks, we assessed accuracy of reporting through the IDSR passive surveillance system. Although the active and passive surveillance represent distinct sets of data, the two were correlated, suggesting that passive surveillance based only on clinical evaluation may be a useful predictor of true cases prior to laboratory confirmation. There were 438 suspect VHF cases reported through the IDSR system and 416 EVD cases officially recorded across the outbreaks examined. Although collected prior to official active surveillance cases, case reporting through the IDSR during the 2007, 2008 and 2012 outbreaks coincided with official EVD epidemic curves. Additionally, all outbreak areas experienced increases in suspected cases for both malaria and typhoid fever during EVD outbreaks, underscoring the importance of training health care workers in recognising EVD differential diagnoses and the potential for co-morbidities. © 2017 John Wiley & Sons Ltd.

Magnet-retained implant-supported overdentures: review and 1-year clinical report.

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Ceruti, Paola; Bryant, S Ross; Lee, Jun-Ho; MacEntee, Michael I

2010-01-01

Open-field aluminum-nickle-cobalt magnets have been used in prosthodontics for many years, but success has been limited because these magnets are susceptible to corrosion by the saliva and because their retentive force is weak relative to the initial retention offered by mechanical attachments. More recently, magnets have been made from alloys of the rare earth elements samarium and neodymium, which provide stronger magnetic force per unit size. In addition, a new generation of laser-welded containers has improved protection from salivary corrosion. The current resurgence of interest in this type of attachment appears justified because, unlike mechanical attachments, magnets have potential for unlimited durability and might therefore be superior to mechanical ball or bar attachments for the retention of removable prostheses on implants. To date, no long-term prospective trials have been conducted to confirm the clinical durability of this new generation of magnets for retaining dentures on either teeth or implants. The aim of this study was to document initial clinical experiences and levels of satisfaction among edentulous patients treated with mandibular implant-supported overdentures retained using a new generation of rare-earth magnetic attachments. At the outset, all but one of the 17 patients had had several years of experience with implant-supported overdentures. During the first year, the mean overall satisfaction among these 17 patients increased from less than 70 to over 90 out of 100 (standardized visual analogue scale). No unusual difficulties were encountered in rendering the treatment or maintaining the attachments. This report offers preliminary evidence of the excellent potential of these magnets for retaining mandibular implant-supported overdentures.

Evidence-based design and evaluation of a whole genome sequencing clinical report for the reference microbiology laboratory

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Crisan, Anamaria; McKee, Geoffrey; Munzner, Tamara

2018-01-01

Background Microbial genome sequencing is now being routinely used in many clinical and public health laboratories. Understanding how to report complex genomic test results to stakeholders who may have varying familiarity with genomics—including clinicians, laboratorians, epidemiologists, and researchers—is critical to the successful and sustainable implementation of this new technology; however, there are no evidence-based guidelines for designing such a report in the pathogen genomics domain. Here, we describe an iterative, human-centered approach to creating a report template for communicating tuberculosis (TB) genomic test results. Methods We used Design Study Methodology—a human centered approach drawn from the information visualization domain—to redesign an existing clinical report. We used expert consults and an online questionnaire to discover various stakeholders’ needs around the types of data and tasks related to TB that they encounter in their daily workflow. We also evaluated their perceptions of and familiarity with genomic data, as well as its utility at various clinical decision points. These data shaped the design of multiple prototype reports that were compared against the existing report through a second online survey, with the resulting qualitative and quantitative data informing the final, redesigned, report. Results We recruited 78 participants, 65 of whom were clinicians, nurses, laboratorians, researchers, and epidemiologists involved in TB diagnosis, treatment, and/or surveillance. Our first survey indicated that participants were largely enthusiastic about genomic data, with the majority agreeing on its utility for certain TB diagnosis and treatment tasks and many reporting some confidence in their ability to interpret this type of data (between 58.8% and 94.1%, depending on the specific data type). When we compared our four prototype reports against the existing design, we found that for the majority (86.7%) of design

Evidence-based design and evaluation of a whole genome sequencing clinical report for the reference microbiology laboratory

Directory of Open Access Journals (Sweden)

Anamaria Crisan

2018-01-01

Full Text Available Background Microbial genome sequencing is now being routinely used in many clinical and public health laboratories. Understanding how to report complex genomic test results to stakeholders who may have varying familiarity with genomics—including clinicians, laboratorians, epidemiologists, and researchers—is critical to the successful and sustainable implementation of this new technology; however, there are no evidence-based guidelines for designing such a report in the pathogen genomics domain. Here, we describe an iterative, human-centered approach to creating a report template for communicating tuberculosis (TB genomic test results. Methods We used Design Study Methodology—a human centered approach drawn from the information visualization domain—to redesign an existing clinical report. We used expert consults and an online questionnaire to discover various stakeholders’ needs around the types of data and tasks related to TB that they encounter in their daily workflow. We also evaluated their perceptions of and familiarity with genomic data, as well as its utility at various clinical decision points. These data shaped the design of multiple prototype reports that were compared against the existing report through a second online survey, with the resulting qualitative and quantitative data informing the final, redesigned, report. Results We recruited 78 participants, 65 of whom were clinicians, nurses, laboratorians, researchers, and epidemiologists involved in TB diagnosis, treatment, and/or surveillance. Our first survey indicated that participants were largely enthusiastic about genomic data, with the majority agreeing on its utility for certain TB diagnosis and treatment tasks and many reporting some confidence in their ability to interpret this type of data (between 58.8% and 94.1%, depending on the specific data type. When we compared our four prototype reports against the existing design, we found that for the majority (86.7% of

Evidence-based design and evaluation of a whole genome sequencing clinical report for the reference microbiology laboratory.

Science.gov (United States)

Crisan, Anamaria; McKee, Geoffrey; Munzner, Tamara; Gardy, Jennifer L

2018-01-01

Microbial genome sequencing is now being routinely used in many clinical and public health laboratories. Understanding how to report complex genomic test results to stakeholders who may have varying familiarity with genomics-including clinicians, laboratorians, epidemiologists, and researchers-is critical to the successful and sustainable implementation of this new technology; however, there are no evidence-based guidelines for designing such a report in the pathogen genomics domain. Here, we describe an iterative, human-centered approach to creating a report template for communicating tuberculosis (TB) genomic test results. We used Design Study Methodology-a human centered approach drawn from the information visualization domain-to redesign an existing clinical report. We used expert consults and an online questionnaire to discover various stakeholders' needs around the types of data and tasks related to TB that they encounter in their daily workflow. We also evaluated their perceptions of and familiarity with genomic data, as well as its utility at various clinical decision points. These data shaped the design of multiple prototype reports that were compared against the existing report through a second online survey, with the resulting qualitative and quantitative data informing the final, redesigned, report. We recruited 78 participants, 65 of whom were clinicians, nurses, laboratorians, researchers, and epidemiologists involved in TB diagnosis, treatment, and/or surveillance. Our first survey indicated that participants were largely enthusiastic about genomic data, with the majority agreeing on its utility for certain TB diagnosis and treatment tasks and many reporting some confidence in their ability to interpret this type of data (between 58.8% and 94.1%, depending on the specific data type). When we compared our four prototype reports against the existing design, we found that for the majority (86.7%) of design comparisons, participants preferred the

Arthritis increases the risk for fractures--results from the Women's Health Initiative.

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Wright, Nicole C; Lisse, Jeffrey R; Walitt, Brian T; Eaton, Charles B; Chen, Zhao

2011-08-01

To examine the relationship between arthritis and fracture. Women were classified into 3 self-reported groups at baseline: no arthritis (n = 83,295), osteoarthritis (OA; n = 63,402), and rheumatoid arthritis (RA; n = 960). Incident fractures were self-reported throughout followup. Age-adjusted fracture rates by arthritis category were generated, and the Cox proportional hazards model was used to test the association between arthritis and fracture. After an average of 7.80 years, 24,137 total fractures were reported including 2559 self-reported clinical spinal fractures and 1698 adjudicated hip fractures. For each fracture type, age-adjusted fracture rates were highest in the RA group and lowest in the nonarthritic group. After adjustment for several covariates, report of arthritis was associated with increased risk for spine, hip, and any clinical fractures. Compared to the nonarthritis group, the risk of sustaining any clinical fracture in the OA group was HR 1.09 (95% CI 1.05, 1.13; p < 0.001) and HR 1.49 (95% CI 1.26, 1.75; p < 0.001) in the RA group. The risk of sustaining a hip fracture was not statistically increased in the OA group (HR 1.11; 95% CI 0.98, 1.25; p = 0.122) compared to the nonarthritis group; however, the risk of hip fracture increased significantly (HR 3.03; 95% CI 2.03, 4.51; p < 0.001) in the RA group compared to the nonarthritis group. The increase in fracture risk confirms the importance of fracture prevention in patients with RA and OA.

Resident's Morning Report: An Opportunity to Reinforce Principles of Biomedical Science in a Clinical Context

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Brass, Eric P.

2013-01-01

The principles of biochemistry are core to understanding cellular and tissue function, as well as the pathophysiology of disease. However, the clinical utility of biochemical principles is often obscure to clinical trainees. Resident's Morning Report is a common teaching conference in which residents present clinical cases of interest to a…

Avoiding pitfalls in diagnosing basilar artery occlusive disease: clinical and imaging clues - case report

Directory of Open Access Journals (Sweden)

Adriana Bastos Conforto

Full Text Available CONTEXT: The aim of this paper was to report on the characteristics that aid in establishing the diagnosis of basilar artery occlusive disease (BAOD among patients with hemiparesis and few or minor symptoms of vertebrobasilar disease. CASE REPORT: This report describes two cases in a public university hospital in São Paulo, Brazil. We present clinical and imaging findings from two patients with hemiparesis and severe BAOD, but without clinically relevant carotid artery disease (CAD. One patient presented transient ischemic attacks consisting of spells of right hemiparesis that became progressively more frequent, up to twice a week. The neurological examination revealed slight right hemiparesis and right homonymous hemianopsia. Magnetic resonance imaging (MRI revealed pontine and occipital infarcts. Magnetic resonance angiography and digital subtraction angiography revealed severe basilar artery stenosis. The other patient presented sudden left-side hemiparesis and hypoesthesia. One year earlier, she had reported sudden onset of vertigo that, at that time, was attributed to peripheral vestibulopathy and was not further investigated. MRI showed a right-side pontine infarct and an old infarct in the right cerebellar hemisphere. Basilar artery occlusion was diagnosed. Both patients presented their symptoms while receiving aspirin, and became asymptomatic after treatment with warfarin. CONCLUSIONS: Misdiagnosing asymptomatic CAD as the cause of symptoms in BAOD can have disastrous consequences, such as unnecessary carotid endarterectomy and exposure to this surgical risk while failing to offer the best available treatment for BAOD. Clinical and imaging features provided important clues for diagnosis in the cases presented.

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO

Directory of Open Access Journals (Sweden)

Raphael Freitas de Souza

2010-04-01

Full Text Available INTRODUCTION: Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. OBJECTIVE: The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. MATERIAL AND METHODS: Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings or randomized controlled trials (RCTs - a random allocation method is clearly reported, according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-to-treat analysis had been carried out. RESULTS: The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3% or concealment of the allocation sequence (84.2%. Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-to-treat analysis or any similar procedure. CONCLUSIONS: The results of

Hibiscus sabdariffa increases hydroxocobalamin oral bioavailability and clinical efficacy in vitamin B12 deficiency with neurological symptoms.

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Souirti, Zouhayr; Loukili, Mouna; Soudy, Imar D; Rtibi, Kaies; Özel, Aslihan; Limas-Nzouzi, Nicolas; El Ouezzani, Seloua; Eto, Bruno

2016-12-01

The aim of the study was to evaluate the bioavailability and clinical benefits of oral new formulation (HB 12 ) of hydroxocobalamin (Hdrx) with Hibiscus sabdariffa (HS). First, in an observational study, a cohort of 30 vitamin B 12 -deficient patients (vit B 12 < 200 pg/mL) with neurological symptoms received oral fixed dose of Hdrx containing 15 mg Hdrx daily for 10 days followed by 15 mg monthly. Clinical benefits were evaluated on haematological and biochemical parameters, and neurological improvement at days 10 and 90 compared to day 0. To understand the mechanism, intestinal mucosa from mice were mounted in vitro in Ussing chambers to measure Hdrx Fluxes. In the clinical study, serum vitamin B 12 level increased from 55.1 ± 36.9 to 1330 ± 335.5 pg/mL at day 10 and 431.0 ± 24.27 pg/mL at day 90, without overt adverse effects. In mice ileum, (i) intestinal bioavailability of Hdrx increased in dose-dependent manner with HB 12 . The apparent permeability of Hdrx was P app = 34.9 ± 4.6 × 10 -6 cm/s in the presence of 3 mg/mL (HB 12 B) compared to the control P app = 6.2 ± 0.7 × 10 -6 cm/s. (ii) Total transepithelial electrical conductance (G t ) increased in dose-dependent manner with HB 12 , G t = 161.5 ± 10.8 mS/cm² with HB 12 B (Hdrx 1 mg + HS 3 mg) compared to the control Hdrx, G t = 28.7 ± 4.0 mS/cm². In conclusion, the clinical study suggests that injections are not required when Hdrx is given orally. Intestinal bioavailability of Hdrx increased in vitro when it was used concomitantly with HS. © 2016 Société Française de Pharmacologie et de Thérapeutique.

Feasibility of the collection of patient-reported outcomes in an ambulatory neurology clinic.

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Moura, Lidia M V R; Schwamm, Eli; Moura Junior, Valdery; Seitz, Michael P; Hsu, John; Cole, Andrew J; Schwamm, Lee H

2016-12-06

To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p Neurology.

Can repair increase the longevity of composite resins? Results of a 10-year clinical trial.

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Fernández, E; Martín, J; Vildósola, P; Oliveira Junior, O B; Gordan, V; Mjor, I; Bersezio, C; Estay, J; de Andrade, M F; Moncada, G

2015-02-01

The aim of this double-blind clinical trial was to assess the longevity of repairs to localized clinical defects in composite resin restorations that were initially planned to be treated with a restoration replacement. Twenty-eight patients aged 18-80 years old with 50 composite resin restorations (CR) were recruited. The restorations with localized, marginal, anatomical deficiencies and/or secondary caries adjacent to CR that were "clinically judged" to be suitable for repair or replacement according to the USPHS criteria were randomly assigned to Repair (n=25) or Replacement (n=25) groups, and the quality of the restorations was scored according to the modified USPHS criteria. The restorations were blind and two examiners scored them at baseline (Cohen Kappa agreement score 0.74) and at ten years (Cohen Kappa agreement score 0.87) restorations. Wilcoxon tests were performed for comparisons within the same group (95% CI), and Friedman tests were utilized for multiple comparisons between the different years within each group. Over the decade, the two groups behaved similarly on the parameters of marginal adaptation (MA) (p>0.05), secondary caries (SC) (p>0.05), anatomy (A) (p0.05). Given that the MA, SC, A and C parameters behaved similarly in both groups, the repair of composite resins should be elected when clinically indicated, because it is a minimally invasive treatment that can consistently increase the longevity of restorations. The repair of defective composite resins as an alternative treatment to increase their longevity proved to be a safe and effective treatment in the long term. Copyright © 2014 Elsevier Ltd. All rights reserved.

Clinical implications of increased use of MRI in TIA.

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Kvistad, C E; Thomassen, L; Waje-Andreassen, U; Moen, G; Logallo, N; Naess, H

2013-07-01

Transient ischemic attack has been redefined as a tissue-based diagnosis and MRI recommended as the preferred imaging modality. We aimed to investigate whether an increased use of MRI leads to a decrease in the proportion of TIA as compared to cerebral infarction. We also sought to see whether DWI-positive patients with transient ischemic symptoms TIA patients in terms of performed diagnostic investigations and clinical characteristics. Patients admitted with cerebral infarction or TIA in the period 2006-2011 were prospectively registered. The use of MRI in patients with transient ischemic symptoms TIA were annually recorded. DWI-positive and DWI-negative patients with transient ischemic symptoms TIA as compared to cerebral infarction decreased from 12.2% in 2006-2008 to 8.3% in 2009-2011 (P = 0.002). DWI-positive patients were more often examined with 24-h Holter monitoring (P TIA definition resulted in a decrease in the proportion of TIA at discharge as compared to cerebral infarction. DWI-positive patients had a more extensive cardiac work-up and were associated with lower age and prior myocardial infarction. © 2012 John Wiley & Sons A/S.

Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports.

Science.gov (United States)

Sharma, Tarang; Guski, Louise Schow; Freund, Nanna; Gøtzsche, Peter C

2016-01-27

To study serious harms associated with selective serotonin and serotonin-norepinephrine reuptake inhibitors.Design Systematic review and meta-analysis. Mortality and suicidality. Secondary outcomes were aggressive behaviour and akathisia. Clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine obtained from the European and UK drug regulators, and summary trial reports for duloxetine and fluoxetine from Eli Lilly's website. Double blind placebo controlled trials that contained any patient narratives or individual patient listings of harms. Two researchers extracted data independently; the outcomes were meta-analysed by Peto's exact method (fixed effect model). We included 70 trials (64,381 pages of clinical study reports) with 18,526 patients. These trials had limitations in the study design and discrepancies in reporting, which may have led to serious under-reporting of harms. For example, some outcomes appeared only in individual patient listings in appendices, which we had for only 32 trials, and we did not have case report forms for any of the trials. Differences in mortality (all deaths were in adults, odds ratio 1.28, 95% confidence interval 0.40 to 4.06), suicidality (1.21, 0.84 to 1.74), and akathisia (2.04, 0.93 to 4.48) were not significant, whereas patients taking antidepressants displayed more aggressive behaviour (1.93, 1.26 to 2.95). For adults, the odds ratios were 0.81 (0.51 to 1.28) for suicidality, 1.09 (0.55 to 2.14) for aggression, and 2.00 (0.79 to 5.04) for akathisia. The corresponding values for children and adolescents were 2.39 (1.31 to 4.33), 2.79 (1.62 to 4.81), and 2.15 (0.48 to 9.65). In the summary trial reports on Eli Lilly's website, almost all deaths were noted, but all suicidal ideation events were missing, and the information on the remaining outcomes was incomplete. Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

Science.gov (United States)

Motte, Anne-France; Diallo, Stéphanie; van den Brink, Hélène; Châteauvieux, Constance; Serrano, Carole; Naud, Carole; Steelandt, Julie; Alsac, Jean-Marc; Aubry, Pierre; Cour, Florence; Pellerin, Olivier; Pineau, Judith; Prognon, Patrice; Borget, Isabelle; Bonan, Brigitte; Martelli, Nicolas

2017-11-01

The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices. Copyright © 2017 Elsevier Inc. All rights reserved.

European Academy of Allergy and Clinical Immunology task force report on 'dose-response relationship in allergen-specific immunotherapy'.

Science.gov (United States)

Calderón, M A; Larenas, D; Kleine-Tebbe, J; Jacobsen, L; Passalacqua, G; Eng, P A; Varga, E M; Valovirta, E; Moreno, C; Malling, H J; Alvarez-Cuesta, E; Durham, S; Demoly, P

2011-10-01

For a century, allergen-specific immunotherapy (SIT) has proven to be an effective treatment for allergic rhinitis, asthma, and insect sting allergy. However, as allergen doses are frequently adapted to the individual patient, there are few data on dose-response relationship in SIT. Allergen products for SIT are being increasingly required to conform to regulatory requirements for human medicines, which include the need to demonstrate dose-dependent effects. This report, produced by a Task Force of the EAACI Immunotherapy Interest Group, evaluates the currently available data on dose-response relationships in SIT and aims to provide recommendations for the design of future studies. Fifteen dose-ranging studies fulfilled the inclusion criteria and twelve reported a dose-response relationship for clinical efficacy. Several studies also reported a dose-response relationship for immunological and safety endpoints. Due to the use of different reference materials and methodologies for the determination of allergen content, variations in study design, and choice of endpoints, no comparisons could be made between studies and, as a consequence, no general dosing recommendations can be made. Despite recently introduced guidelines on the standardization of allergen preparations and study design, the Task Force identified a need for universally accepted standards for the measurement of allergen content in SIT preparations, dosing protocols, and selection of clinical endpoints to enable dose-response effects to be compared across studies. © 2011 John Wiley & Sons A/S.

Phelan-McDermid syndrome data network: Integrating patient reported outcomes with clinical notes and curated genetic reports.

Science.gov (United States)

Kothari, Cartik; Wack, Maxime; Hassen-Khodja, Claire; Finan, Sean; Savova, Guergana; O'Boyle, Megan; Bliss, Geraldine; Cornell, Andria; Horn, Elizabeth J; Davis, Rebecca; Jacobs, Jacquelyn; Kohane, Isaac; Avillach, Paul

2017-09-01

The heterogeneity of patient phenotype data are an impediment to the research into the origins and progression of neuropsychiatric disorders. This difficulty is compounded in the case of rare disorders such as Phelan-McDermid Syndrome (PMS) by the paucity of patient clinical data. PMS is a rare syndromic genetic cause of autism and intellectual deficiency. In this paper, we describe the Phelan-McDermid Syndrome Data Network (PMS_DN), a platform that facilitates research into phenotype-genotype correlation and progression of PMS by: a) integrating knowledge of patient phenotypes extracted from Patient Reported Outcomes (PRO) data and clinical notes-two heterogeneous, underutilized sources of knowledge about patient phenotypes-with curated genetic information from the same patient cohort and b) making this integrated knowledge, along with a suite of statistical tools, available free of charge to authorized investigators on a Web portal https://pmsdn.hms.harvard.edu. PMS_DN is a Patient Centric Outcomes Research Initiative (PCORI) where patients and their families are involved in all aspects of the management of patient data in driving research into PMS. To foster collaborative research, PMS_DN also makes patient aggregates from this knowledge available to authorized investigators using distributed research networks such as the PCORnet PopMedNet. PMS_DN is hosted on a scalable cloud based environment and complies with all patient data privacy regulations. As of October 31, 2016, PMS_DN integrates high-quality knowledge extracted from the clinical notes of 112 patients and curated genetic reports of 176 patients with preprocessed PRO data from 415 patients. © 2017 The Authors. American Journal of Medical Genetics Part B: Neuropsychiatric Genetics Published by Wiley Periodicals, Inc.

Patient- and Physician-reported Satisfaction With Systemic Lupus Erythematosus Treatment in US Clinical Practice.

Science.gov (United States)

Pascoe, Katie; Lobosco, Steve; Bell, David; Hoskin, Ben; Chang, David J; Pobiner, Bonnie; Ramachandran, Sulabha

2017-09-01

This two-part study comprised two descriptive, cross-sectional surveys to evaluate treatment satisfaction among patients with systemic lupus erythematosus (SLE) and their physicians from US clinical practices. The Lupus Plus Project (LPP; part one) involved belimumab-containing regimens; the Disease Specific Program (DSP; part two) included all treatments and was designed to build on the body of evidence from part one. The LPP recruited patients receiving belimumab, and comprised 2 paper questionnaires: a patient self-completion questionnaire (PSC) and a patient record form (PRF) completed by the physician. The DSP enrolled patients with SLE receiving any treatment and comprised four parts: a PSC, a PRF completed by the physician after patient consultation, face-to-face physician interviews, and a workload form completed by the physicians to indicate their total SLE patient workload. The key objective of this study was to assess physician and patient satisfaction with current treatment. From the PSCs, data regarding patient-reported satisfaction with current treatment were available for 263 patients who were receiving belimumab combination therapy (LPP) and 250 patients who were receiving non-belimumab treatment (DSP). The majority of patients (belimumab, 86.3% [227/263]; non-belimumab, 78.4% [196/250]) responded positively (at least "somewhat satisfied") when asked about current treatment satisfaction, as did physicians (belimumab, 82.9% [311/375]; non-belimumab, 74.3% [326/439]). In multivariate analysis, factors most strongly associated with patient-reported satisfaction for patients receiving belimumab were patient-reported improvements in leisure activities since taking belimumab (odds ratio [OR] = 4.66), physician-reported improvements in fatigue (OR = 3.72), patient-reported improvements in general symptoms (OR = 3.02), and pain/achiness (OR = 2.71). Physician satisfaction was associated with clinical outcome such as improvements in pain/achiness (OR = 6

Ultrasonographic and clinical features of fetal cholelithiasis. Three case reports

International Nuclear Information System (INIS)

Agnifili, Alessio; Gola, Piersante; Marino, Maria; Verzaro, Roberto; Carducci, Giuseppe; Mancini, Ermanno; Rizzo, Franz Maria; Carducci, Augusto; Biasini, Giancarlo

1997-01-01

Fetal cholelithiasis was first diagnosed in 1983 and since then there have been only few reports about the presence of gallstones in the fetus. Maternal conditions, fetal or obstetrical predisposing risk factors have been proposed to have a causative role, by the pathogenesis of fetal gallstones remains unknown. Clinical sequelae of fetal gallstones are poorly understood as well as the role of fetal cholelithiasis in predisposing the adult to gallstones. They report on 3 patients whose cholelithiasis was diagnosed by obstetrical ultrasonography. Repeated ultrasound scans were performed in each patient until resolution of the US images. The goal of US was to correctly identify the number, size and US features of the material within the gallbladder. The presence of distal shadowing or comet-tail artifact was assess. Multiple, small echogenic foci without distal shadowing were recognized in the fetal gallbladder in their patients. In the third case echogenic foci disappeared during pregnancy. In all the cases, US showed no biliary tract abnormality, and neither the mothers nor the patients had clinical or laboratory findings consistent with liver or biliary diseases. The authors discuss a diagnostic protocol to detect and follow-up gallstones in the perinatal period by ultrasonography. In their experience, fetal cholelithiasis confirmed to be a self-limiting disease without complications and did not require any form of therapy. However a close follow-up is indicated in these patients until spontaneous resolution is demonstrated by US

First report of clinical presentation of a bite by a running spider ...

African Journals Online (AJOL)

This article describes the clinical progression of symptoms over a period of 5 days of a bite inflicted by a Philodromus sp. spider. Commonly known as 'running spiders', these are not considered to be harmful to humans. This report, however, is the first description of an actual bite by a member of this group of spiders ...

Writing Research Reports.

Science.gov (United States)

Sessler, Daniel I; Shafer, Steven

2018-01-01

Clear writing makes manuscripts easier to understand. Clear writing enhances research reports, increasing clinical adoption and scientific impact. We discuss styles and organization to help junior investigators present their findings and avoid common errors.

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

DEFF Research Database (Denmark)

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

2014-01-01

in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...... identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary...

Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

DEFF Research Database (Denmark)

Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

2017-01-01

BACKGROUND: The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse effects...... of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. METHODS: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total...... of 1913 patients) submitted to the European Medicines Agency for marketing approval for the indication of stress urinary incontinence in women. We used data from the clinical study reports (totalling 6870 pages and including individual patient data) to assess benefits (including frequency of incontinence...

Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment.

Science.gov (United States)

Onslow, Mark; Jones, Mark; O'Brian, Sue; Packman, Ann; Menzies, Ross; Lowe, Robyn; Arnott, Simone; Bridgman, Kate; de Sonneville, Caroline; Franken, Marie-Christine

2018-04-17

This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland-Altman plots, analysis of covariance, and Spearman rho correlations. Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.

Poor Semen Quality Predicts Increased Mortality

DEFF Research Database (Denmark)

Jensen, Tina Kold; Bostofte, Erik; Jacobsen, Rune

Objective: Over recent decades a possible decrease in semen quality and an increase in the incidence of testicular cancer have been reported. In addition, men with poor semen quality have been reported to be at increased risk of developing testicular cancer whereas the risk of other cancers...... is not increased. The long-term survival of men with poor semen quality is, however, unknown. We therefore studied the associations between semen characteristics and subsequent mortality. Back to Top Material and Methods: The Copenhagen Sperm Analysis Laboratory is one of several public semen analysis laboratories...... in Denmark and examines semen samples mostly from men in the area of Copenhagen. Men are referred to the clinic by general practitioners and urologists, and the investigations are paid for through the public health system. A total of 34.442 men had a semen analysis done at the laboratory during 1963 to 1995...

An analysis of redactions in Canada's Common Drug Review Clinical Review Reports and how they relate to the patients' voice.

Science.gov (United States)

Soprovich, Allison; El Kurdi, Sylvia; Eurich, Dean T

2017-09-11

Canada's Common Drug Review (CDR) evaluates drug data from published and unpublished research, as well as input from patient groups, to recommend provincial coverage. Currently, the CDR process gives manufacturers the opportunity to redact information in the final publicly available report. Patients often have strong feelings regarding the efficacy, harms, health-related quality of life (HRQL), and cost associated with the drugs under review and their redacted data. Highlighting Canada's approach will hopefully build on the growing international concern regarding transparency of clinical study data. The purpose was to objectively examine and classify completed, publicly available CDR-Clinical Review Reports (CRR) for redactions, and compare them to the patients' reported interests as patient-centred outcomes. Two independent reviewers searched for and examined publicly available CDR-CRR from November 2013-September 2016 through the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database. Both reviewers separately classified the redactions and patient-reported interests into the following categories: efficacy, harms, HRQL and costs. All discrepancies were rectified by consensus involving a third reviewer. Fifty-two completed CDR-CRR were reviewed. 48 (92%) included patient-reported interests and 40 (77%) had redactions classified in the following categories: efficacy (75%), costs (48%), harms (38%), HRQL (23%). 89% of redactions were outcomes identified as patient-reported interests (69% efficacy, 42% harms, 36% cost, 33% HRQL). When examining drug characteristics, biological agents were statistically associated with increased odds of redactions with respect to either efficacy (OR 3.4, 95% CI 1.0 to 11.6) or harms (OR 3.5, 95% CI 1.02 to 12.4) compared with non-biological agents. Whether data from the CDR-CRR used in the decision-making should be fully disclosed to the public is controversial. Our findings suggest clinical data (efficacy

Demographic and clinical characteristics of consistent and inconsistent longitudinal reporters of lifetime suicide attempts in adolescence through young adulthood.

Science.gov (United States)

Hart, Shelley R; Musci, Rashelle J; Ialongo, Nicholas; Ballard, Elizabeth D; Wilcox, Holly C

2013-10-01

Within the context of the recent release of the 2012 National Suicide Prevention Strategy, and as the third leading cause of death for individuals 10- to 24-years-old, suicide prevention is a national priority. A consistently reported and robust risk factor for suicide is a prior suicide attempt; however few studies have investigated the consistency of self-reported lifetime suicide attempts. The goal of this study is to describe the prevalence and characteristics of inconsistent reporting of suicide attempt in a longitudinal cohort of participants annually assessed in 12 waves of data collected from middle school (age 12) to early adulthood (age 22). Among this cohort (n = 678), we compared those who consistently, inconsistently, and never reported a suicide attempt according to demographic and clinical variables. Almost 90% (88.5%) of our sample inconsistently reported a lifetime suicide attempt. Consistent and inconsistent reporters of lifetime suicide attempt did not differ on demographic or clinical variables with the exception of higher rates of lifetime suicidal ideation among consistent reporters (P adolescents. Inconsistent and consistent reporters of suicide attempt differ on few demographic or clinical variables; further prospective research should investigate the reasons for inconsistent reporting as well as the validity and stability of reporting in predicting future suicidal behavior. © 2013 Wiley Periodicals, Inc.

Clinical Validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62): Further Evaluation and Clinical Applications

Science.gov (United States)

McAleavey, Andrew A.; Nordberg, Samuel S.; Hayes, Jeffrey A.; Castonguay, Louis G.; Locke, Benjamin D.; Lockard, Allison J.

2012-01-01

Self-report instruments of psychological symptoms are increasingly used in counseling centers but rely on rigorous evaluation of their clinical validity. Three studies reported here (total N = 26,886) investigated the validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62; Locke et al., 2011) as an assessment and…

Research and Clinical Center for Child Development Annual Report, 1995-1996, No. 19.

Science.gov (United States)

Wakai, Kunio, Ed.; Chen, Shing-Jen, Ed.; Furutsuka, Takashi, Ed.; Shirotani, Yukari, Ed.

This annual report discusses several topics related to the work of the Research and Clinical Center for Child Development at Hokkaido University in Japan. The articles are: (1) "Heart to Heart (Inter "Jo") Resonance: Taking Japanese Concept of Intersubjectivity Out of Everyday Life" (Shigeru Nakano); (2) "Intersubjectivity…

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement

Science.gov (United States)

MacPherson, Hugh; Altman, Douglas G; Hammerschlag, Richard; Li, Youping; Wu, Taixiang; White, Adrian; Moher, David

2010-01-01

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture. PMID:20615861

The spatial context of clinic-reported sexually transmitted infection in Hong Kong.

Science.gov (United States)

Lee, Shui-Shan; Ho, King-Man; Cheung, Georgiana M T

2010-09-21

The incidence and prevalence of sexually transmitted infection (STI) in China has been on the rise in the past decade. Delineation of epidemiologic pattern is often hampered by its uneven distribution. Spatial distribution is often a neglected aspect of STI research, the description of which may enhance epidemiologic surveillance and inform service development. Over a one month-period, all first time attendees of 6 public STI clinics in Hong Kong were interviewed before clinical consultation using a standard questionnaire to assess their demographic, clinical and behavioural characteristics. A GIS (geographic information system)-based approach was adopted with mapping performed. The cases attending the clinics in different locations were profiled. A comparison was made between neighbourhood cases (patients living near a clinic) and distant cases (those farther off), by calculating the odds ratio for demographic, behavioural and geographic characteristics. Of the 1142 STI patients evaluated, the residence locations of 1029 (90.1%) could be geocoded, of which 95.6% were ethnic Chinese and 63.4% male. Geographically only about a quarter lived in the same district as the clinic. STI patients aged 55 or above were more likely to be living in the vicinity of the clinic, located in the same or adjacent tertiary planning unit (a small geographic unit below district level). A majority of patients came from locations a few kilometers from the clinic, the distance of which varies between clinics. Overall, more syphilis cases were reported in patients residing in the same or adjacent tertiary planning unit, while distant cases tended to give a higher risk of inconsistent condom use. There were otherwise no significant clinical and epidemiologic differences between neighbourhood and distant STI cases. There was no specific relationship between STI and the residence location of patients as regards their clinical and epidemiologic characteristics in the territory of Hong Kong

The spatial context of clinic-reported sexually transmitted infection in Hong Kong

Directory of Open Access Journals (Sweden)

Cheung Georgiana MT

2010-09-01

Full Text Available Abstract Background The incidence and prevalence of sexually transmitted infection (STI in China has been on the rise in the past decade. Delineation of epidemiologic pattern is often hampered by its uneven distribution. Spatial distribution is often a neglected aspect of STI research, the description of which may enhance epidemiologic surveillance and inform service development. Methods Over a one month-period, all first time attendees of 6 public STI clinics in Hong Kong were interviewed before clinical consultation using a standard questionnaire to assess their demographic, clinical and behavioural characteristics. A GIS (geographic information system-based approach was adopted with mapping performed. The cases attending the clinics in different locations were profiled. A comparison was made between neighbourhood cases (patients living near a clinic and distant cases (those farther off, by calculating the odds ratio for demographic, behavioural and geographic characteristics. Results Of the 1142 STI patients evaluated, the residence locations of 1029 (90.1% could be geocoded, of which 95.6% were ethnic Chinese and 63.4% male. Geographically only about a quarter lived in the same district as the clinic. STI patients aged 55 or above were more likely to be living in the vicinity of the clinic, located in the same or adjacent tertiary planning unit (a small geographic unit below district level. A majority of patients came from locations a few kilometers from the clinic, the distance of which varies between clinics. Overall, more syphilis cases were reported in patients residing in the same or adjacent tertiary planning unit, while distant cases tended to give a higher risk of inconsistent condom use. There were otherwise no significant clinical and epidemiologic differences between neighbourhood and distant STI cases. Conclusions There was no specific relationship between STI and the residence location of patients as regards their clinical and

Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals

Directory of Open Access Journals (Sweden)

E.D. Moreira Jr.

2001-11-01

Full Text Available Results of subgroup analysis (SA reported in randomized clinical trials (RCT cannot be adequately interpreted without information about the methods used in the study design and the data analysis. Our aim was to show how often inaccurate or incomplete reports occur. First, we selected eight methodological aspects of SA on the basis of their importance to a reader in determining the confidence that should be placed in the author's conclusions regarding such analysis. Then, we reviewed the current practice of reporting these methodological aspects of SA in clinical trials in four leading journals, i.e., the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet, and the American Journal of Public Health. Eight consecutive reports from each journal published after July 1, 1998 were included. Of the 32 trials surveyed, 17 (53% had at least one SA. Overall, the proportion of RCT reporting a particular methodological aspect ranged from 23 to 94%. Information on whether the SA preceded/followed the analysis was reported in only 7 (41% of the studies. Of the total possible number of items to be reported, NEJM, JAMA, Lancet and AJPH clearly mentioned 59, 67, 58 and 72%, respectively. We conclude that current reporting of SA in RCT is incomplete and inaccurate. The results of such SA may have harmful effects on treatment recommendations if accepted without judicious scrutiny. We recommend that editors improve the reporting of SA in RCT by giving authors a list of the important items to be reported.

Trichotillomania: a case report with clinical and dermatoscopic differential diagnosis with alopecia areata.

Science.gov (United States)

Pinto, Ana Cecília Versiani Duarte; Andrade, Tatiana Cristina Pedro Cordeiro de; Brito, Fernanda Freitas de; Silva, Gardênia Viana da; Cavalcante, Maria Lopes Lamenha Lins; Martelli, Antonio Carlos Ceribelli

2017-01-01

Trichotillomania is a psychodermatologic disorder characterized by uncontrollable urge to pull one's own hair. Differential diagnoses include the most common forms of alopecia such as alopecia areata. It is usually associated with depression and obsessive-compulsive disorder. Trichotillomania treatment standardization is a gap in the medical literature. Recent studies demonstrated the efficacy of N-acetylcysteine (a glutamate modulator) for the treatment of the disease. We report the clinical case of a 12-year-old female patient who received the initial diagnosis of alopecia areata, but presented with clinical and dermoscopic features of trichotillomania. She was treated with the combination of psychotropic drugs and N-acetylcysteine with good clinical response. Due to the chronic and recurring nature of trichotillomania, more studies need to be conducted for the establishment of a formal treatment algorithm.

Clinical findings in two cases of atypical scrapie in sheep: a case report

Directory of Open Access Journals (Sweden)

Chaplin Melanie

2007-02-01

Full Text Available Abstract Background Atypical scrapie is a recently recognised form of transmissible spongiform encephalopathy of sheep that differs from classical scrapie in its neuropathological and biochemical features. Most cases are detected in apparently healthy sheep and information on the clinical presentation is limited. Case presentation This report describes the clinical findings in two sheep notified as scrapie suspects and confirmed as atypical scrapie cases by immunohistochemistry and Western immunoblotting. Although both sheep displayed signs suggestive of a cerebellar dysfunction there was considerable variation in the individual clinical signs, which were similar to classical scrapie. Conclusion Any sheep presenting with neurological gait deficits should be assessed more closely for other behavioural, neurological and physical signs associated with scrapie and their presence should lead to the suspicion of scrapie.

A parent-report Gender Identity Questionnaire for Children: A cross-national, cross-clinic comparative analysis.

Science.gov (United States)

Cohen-Kettenis, Peggy T; Wallien, Madeleine; Johnson, Laurel L; Owen-Anderson, Allison F H; Bradley, Susan J; Zucker, Kenneth J

2006-07-01

A one-factor, 14-item parent-report Gender Identity Questionnaire for Children (GIQC) was developed in a sample of 325 clinic-referred children with gender identity problems and 504 controls from Toronto, Canada (Johnson et al., 2004). In this study, we report a cross-national, cross-clinic comparative analysis of the GIQC on gender-referred children (N = 338) from Toronto and gender-referred children (N = 175) from Utrecht, The Netherlands. Across clinics, the results showed both similarities and differences. Gender-referred boys from Utrecht had a significantly higher total score (indicating more cross-gender behavior) than did gender-referred boys from Toronto, but there was no significant difference for girls. In the Toronto sample, the gender-referred girls had a significantly higher total score than the gender-referred boys, but there was no significant sex difference in the Utrecht sample. Across both clinics, gender-referred children who met the complete DSM criteria for gender identity disorder (GID) had a significantly higher cross-gender score than the gender-referred children who were subthreshold for GID (Cohen's d = 1.11). The results of this study provide the first empirical evidence of relative similarity in cross-gender behavior in a sample of gender-referred children from western Europe when compared to North American children. The results also provide some support for cross-clinic consistency in clinician-based diagnosis of GID.

Clinical educators' self-reported personal and professional ...

African Journals Online (AJOL)

The target group was inter-professional clinical educators that are involved in student education on the clinical platform. Although the course participants were professionals and specialists in their own fields, the majority of clinical educators have very little or no knowledge of adult education. The Supervision Course aims to ...

Authors of clinical trials reported individual and financial conflicts of interest more frequently than institutional and nonfinancial ones: a methodological survey.

Science.gov (United States)

Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane A; Hasbani, Divina Justina; Abou-Jaoude, Elias A; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Z; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A

2017-07-01

Conflicts of interest (COIs) are increasingly recognized as important to disclose and manage in health research. The objective of this study was to assess the reporting of both financial and nonfinancial COI by authors of randomized controlled trials published in a representative sample of clinical journals. We searched Ovid Medline and included a random sample of 200 randomized controlled trials published in 2015 in one of the 119 Core Clinical Journals. We classified COI using a comprehensive framework that includes the following: individual COIs (financial, professional, scholarly, advocatory, personal) and institutional COIs (financial, professional, scholarly, and advocatory). We conducted descriptive and regression analyses. Of the 200 randomized controlled trials, 188 (94%) reported authors' COI disclosures that were available in the main document (92%) and as International Committee of Medical Journal Editors forms accessible online (12%). Of the 188 trials, 57% had at least one author reporting at least one COI; in all these trials, at least one author reported financial COI. Institutional COIs (11%) and nonfinancial COIs (4%) were less commonly reported. References to COI disclosure statements for editors (1%) and medical writers (0%) were seldom present. Regression analyses showed positive associations between reporting individual financial COI and higher journal impact factor (odds ratio [OR] = 1.06, 95% confidence interval [CI] = 1.02-1.10), larger number of authors (OR = 1.10, 95% CI 1.02-1.20), affiliation with an institution from a high-income country (OR = 16.75, 95% CI 3.38-82.87), and trials reporting on pharmacological interventions (OR = 2.28, 95% CI 1.13-4.62). More than half of published randomized controlled trials report that at least one author has a COI. Trial authors report financial COIs more often than nonfinancial COIs and individual COIs more frequently than institutional COIs. Copyright © 2017 Elsevier Inc. All rights

MR imaging of pregnancy luteoma: a case report and correlation with the clinical features

Energy Technology Data Exchange (ETDEWEB)

Kao, Hung Wen; Wu, Ching Jiunn; Chung, Kuo Teng; Wang, Sheng Ru; Chen, Cheng Yu [Tri-Service General Hospital, National Defense Medical Center, Taipei (Taiwan)

2005-03-15

We report here on a 26-year-old pregnant female who developed hirsutism and virilization during her third trimester along with a significantly elevated serum testosterone level. Abdominal US and MR imaging studies were performed, and they showed unique imaging features that may suggest the diagnosis of pregnancy luteoma in the clinical context. After the delivery, the serum testosterone level continued to decrease, and it returned to normal three weeks postpartum. The follow-up imaging findings were closely correlated with the clinical presentation.

Intensity-modulated radiotherapy for pituitary adenomas: The preliminary report of Cleveland Clinic experience

International Nuclear Information System (INIS)

Mackley, Heath B.; Reddy, Chandana A. M.S.; Lee, S.-Y.; Harnisch, Gayle A.; Mayberg, Marc R.; Hamrahian, Amir H.; Suh, John H.

2007-01-01

Purpose: Intensity-modulated radiotherapy (IMRT) is being increasingly used for the treatment of pituitary adenomas. However, there have been few published data on the short- and long-term outcomes of this treatment. This is the initial report of Cleveland Clinic's experience. Methods and Materials: Between February 1998 and December 2003, 34 patients with pituitary adenomas were treated with IMRT. A retrospective chart review was conducted for data analysis. Results: With a median follow-up of 42.5 months, the treatment has proven to be well tolerated, with performance status remaining stable in 90% of patients. Radiographic local control was 89%, and among patients with secretory tumors, 100% had a biochemical response. Only 1 patient required salvage surgery for progressive disease, giving a clinical progression free survival of 97%. The only patient who received more than 46 Gy experienced optic neuropathy 8 months after radiation. Smaller tumor volume significantly correlated with subjective improvements in nonvisual neurologic complaints (p = 0.03), and larger tumor volume significantly correlated with subjective worsening of visual symptoms (p = 0.05). New hormonal supplementation was required for 40% of patients. Younger patients were significantly more likely to require hormonal supplementation (p 0.03). Conclusions: Intensity-modulated radiation therapy is a safe and effective treatment for pituitary adenomas over the short term. Longer follow-up is necessary to determine if IMRT confers any advantage with respect to either tumor control or toxicity over conventional radiation modalities

Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology.

Science.gov (United States)

Rorie, David A; Flynn, Robert W V; Grieve, Kerr; Doney, Alexander; Mackenzie, Isla; MacDonald, Thomas M; Rogers, Amy

2017-09-01

Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underused despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research. The review used PubMed and the Institute of Electrical and Electronic Engineers library. Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas Institute of Electrical and Electronic Engineers is technology based. The review focuses on electronic case report forms and electronic data capture, but briefly considers other relevant topics; consent, ethics and security. There were 1126 papers found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorized: 17 contained study data; 40 observational data; 27 anecdotal data; 47 covering methodology or design of systems; one case study; one literature review; two feasibility studies; and one cost analysis. Electronic case report forms, electronic data capture and IT in general are viewed with enthusiasm and are seen as a cost-effective means of improving research efficiency, educating participants and improving trial recruitment, provided concerns about how data will be protected from misuse can be addressed. Clear operational guidelines and best practises are key for healthcare providers, and researchers adopting IT, and further work is needed on improving integration of new technologies with current systems. A robust method of evaluation for technical innovation is required. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Multi-morbidities of allergic rhinitis in adults: European Academy of Allergy and Clinical Immunology Task Force Report.

Science.gov (United States)

Cingi, C; Gevaert, P; Mösges, R; Rondon, C; Hox, V; Rudenko, M; Muluk, N B; Scadding, G; Manole, F; Hupin, C; Fokkens, W J; Akdis, C; Bachert, C; Demoly, P; Mullol, J; Muraro, A; Papadopoulos, N; Pawankar, R; Rombaux, P; Toskala, E; Kalogjera, L; Prokopakis, E; Hellings, P W; Bousquet, J

2017-01-01

This report has been prepared by the European Academy of Allergy and Clinical Immunology Task Force on Allergic Rhinitis (AR) comorbidities. The aim of this multidisciplinary European consensus document is to highlight the role of multimorbidities in the definition, classification, mechanisms, recommendations for diagnosis and treatment of AR, and to define the needs in this neglected area by a literature review. AR is a systemic allergic disease and is generally associated with numerous multi-morbid disorders, including asthma, eczema, food allergies, eosinophilic oesophagitis (EoE), conjunctivitis, chronic middle ear effusions, rhinosinusitis, adenoid hypertrophy, olfaction disorders, obstructive sleep apnea, disordered sleep and consequent behavioural and educational effects. This report provides up-to-date usable information to: (1) improve the knowledge and skills of allergists, so as to ultimately improve the overall quality of patient care; (2) to increase interest in this area; and (3) to present a unique contribution to the field of upper inflammatory disease.

The Coronary Artery Disease-Reporting and Data System (CAD-RADS): Prognostic and Clinical Implications Associated With Standardized Coronary Computed Tomography Angiography Reporting.

Science.gov (United States)

Xie, Joe X; Cury, Ricardo C; Leipsic, Jonathon; Crim, Matthew T; Berman, Daniel S; Gransar, Heidi; Budoff, Matthew J; Achenbach, Stephan; Ó Hartaigh, Bríain; Callister, Tracy Q; Marques, Hugo; Rubinshtein, Ronen; Al-Mallah, Mouaz H; Andreini, Daniele; Pontone, Gianluca; Cademartiri, Filippo; Maffei, Erica; Chinnaiyan, Kavitha; Raff, Gilbert; Hadamitzky, Martin; Hausleiter, Joerg; Feuchtner, Gudrun; Dunning, Allison; DeLago, Augustin; Kim, Yong-Jin; Kaufmann, Philipp A; Villines, Todd C; Chow, Benjamin J W; Hindoyan, Niree; Gomez, Millie; Lin, Fay Y; Jones, Erica; Min, James K; Shaw, Leslee J

2018-01-01

This study sought to assess clinical outcomes associated with the novel Coronary Artery Disease-Reporting and Data System (CAD-RADS) scores used to standardize coronary computed tomography angiography (CTA) reporting and their potential utility in guiding post-coronary CTA care. Clinical decision support is a major focus of health care policies aimed at improving guideline-directed care. Recently, CAD-RADS was developed to standardize coronary CTA reporting and includes clinical recommendations to facilitate patient management after coronary CTA. In the multinational CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) registry, 5,039 patients without known coronary artery disease (CAD) underwent coronary CTA and were stratified by CAD-RADS scores, which rank CAD stenosis severity as 0 (0%), 1 (1% to 24%), 2 (25% to 49%), 3 (50% to 69%), 4A (70% to 99% in 1 to 2 vessels), 4B (70% to 99% in 3 vessels or ≥50% left main), or 5 (100%). Kaplan-Meier and multivariable Cox models were used to estimate all-cause mortality or myocardial infarction (MI). Receiver-operating characteristic (ROC) curves were used to compare CAD-RADS to the Duke CAD Index and traditional CAD classification. Referrals to invasive coronary angiography (ICA) after coronary CTA were also assessed. Cumulative 5-year event-free survival ranged from 95.2% to 69.3% for CAD-RADS 0 to 5 (p data, 57% of CAD-RADS 3 patients who received 30-day ICA were either asymptomatic or not receiving antianginal therapy at baseline, whereas only 32% had angina and were receiving medical therapy. CAD-RADS effectively identified patients at risk for adverse events. Frequent ICA use was observed among patients without severe CAD, many of whom were asymptomatic or not taking antianginal drugs. Incorporating CAD-RADS into coronary CTA reports may provide a novel opportunity to promote evidence-based care post-coronary CTA. Copyright © 2018 American College of Cardiology

Increasing resistant coagulase negative staphylococci in bovine clinical mastitis.

Science.gov (United States)

Moniri, R; Dastehgoli, K; Akramian, A

2007-08-01

The aim of this study was to determine Coagulase Negative Staphylococci (CNS) and other bacteria for their resistance to antimicrobial agents approved for the control of pathogens involved in clinical bovine mastitis. This descriptive study was done on 106 milk samples obtained from clinical mastitis in dairy cattle husbandry from April 2006 through August 2006 in Kashan, Iran. From the total of 106 milk samples collected from clinical mastitis, 96 (90.6%) lead to positive culture. Coagulase negative Staphylococci isolated in 51 out of 96 samples (53.1%), Staphylococcus aureus isolated in 21 out of 96 (21.9%), gram negative bacilli isolated in 14 out of 96 (14.6%) and Enterococci isolated in 4 (4.2%). The highest rate of resistant CNS observed to penicillin (56.6%) and the highest rate of sensitivity to enrofloxacin 100%, followed by kanamycin, streptomycin and neomycin, 92.2, 82.3 and 82.3%, respectively. The highest rate of resistance S. aureus exhibited to penicillin (66.6%); while the highest rate of sensitivity showed to trimethoprim-sulphamethoxasole (81%), followed by kanamycin and enrofloxacin both at 76.2%. The highest rate of resistance gram negative bacilli exhibited to ampicillin and erythromycin at 71.4%. Their highest rate of sensitivity observed to enrofloxacin (78.6%), followed by kanamycin, (71.4%). In recent years, CNS is emerging as important minor mastitis pathogens and can be the cause of substantial economic losses. The high resistance rate to penicillin and other antibiotics found in this study emphasize the importance of identification of CNS when a bovine clinical mastitis is present.

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study.

Science.gov (United States)

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

2014-06-04

To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Clinical study reports obtained from the EMA in 2011. Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives

Reporting of clinical trials: a review of research funders' guidelines

Directory of Open Access Journals (Sweden)

Williamson Paula R

2008-11-01

Full Text Available Abstract Background Randomised controlled trials (RCTs represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias

The usefulness of a mobile device-based system for patient-reported outcomes in a spine outpatient clinic.

Science.gov (United States)

Kim, Chi Heon; Chung, Chun Kee; Choi, Yunhee; Shin, HyunJeong; Woo, Ji Won; Kim, Sung-Mi; Lee, Hyuk-Joon

2016-07-01

Patient-reported outcomes (PROs) are typically collected using a paper form, but this format is cumbersome to incorporate into outpatient clinic visits as well as in research. Therefore, we developed a mobile device-based system (mobile system) for spinal PRO. We hypothesized that this system may improve the quality of care in an outpatient clinic. This study aimed to analyze the patient-reported efficacy of a mobile system through a survey of patients' responses compared with a paper system. A prospective observational study was carried out. Surveys were conducted for 103 patients who had experience using both the paper and electronic systems in the outpatient clinic. Patient-reported positive response score (PRS) was the outcome measure. The survey included the characteristics of the patients (sex, age, use of smartphone, familiarity with smartphone applications, proficiency of typing with mobile device, site of pain, and education level) and eight questions in four domains: (1) efficacy in the waiting room, (2) efficacy during the clinic visit, (3) overall satisfaction, and (4) opinion about the use of this system. The response to each question was scored from 1 to 5 (1, negative; 5, positive response). The patient-reported PRS was calculated by adding the scores of the 8 questions and converting the total range to 0-100 (60, neutral). The mean PRS of the 8 questions was 79.8 (95% CI, 76.7-83.9). The mean PRS was 78.9 (75.6-82.2) at the waiting room and was 80.5 (77.1-83.9) during the clinic. The PRS for overall satisfaction and use of this system were 83.3 (79.6-87.0) and 77.1 (71.9-82.3), respectively. The use of smartphones and the proficiency of typing were independently significant predictors of PRS with an R(2) value of 0.325. The mobile device-based system improved the patient-reported efficacy in spine outpatient clinics. However, various factors such as the use of smartphones need to be considered when developing and applying mobile systems. Copyright �

Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

Science.gov (United States)

Tonetti, Maurizio; Palmer, Richard

2012-02-01

The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome

Confirmation of the reported association of clonal chromosomal mosaicism with an increased risk of incident hematologic cancer.

Directory of Open Access Journals (Sweden)

Ursula M Schick

Full Text Available Chromosomal abnormalities provide clinical utility in the diagnosis and treatment of hematologic malignancies, and may be predictive of malignant transformation in individuals without apparent clinical presentation of a hematologic cancer. In an effort to confirm previous reports of an association between clonal mosaicism and incident hematologic cancer, we applied the anomDetectBAF algorithm to call chromosomal anomalies in genotype data from previously conducted Genome Wide Association Studies (GWAS. The genotypes were initially collected from DNA derived from peripheral blood of 12,176 participants in the Group Health electronic Medical Records and Genomics study (eMERGE and the Women's Health Initiative (WHI. We detected clonal mosaicism in 169 individuals (1.4% and large clonal mosaic events (>2 mb in 117 (1.0% individuals. Though only 9.5% of clonal mosaic carriers had an incident diagnosis of hematologic cancer (multiple myeloma, myelodysplastic syndrome, lymphoma, or leukemia, the carriers had a 5.5-fold increased risk (95% CI: 3.3-9.3; p-value = 7.5×10(-11 of developing these cancers subsequently. Carriers of large mosaic anomalies showed particularly pronounced risk of subsequent leukemia (HR = 19.2, 95% CI: 8.9-41.6; p-value = 7.3×10(-14. Thus we independently confirm the association between detectable clonal mosaicism and hematologic cancer found previously in two recent publications.

improving clinical practice through simulation: a case study of ...

African Journals Online (AJOL)

PROF. BARTH EKWEME

students' perceptions of clinical simulation as a teaching/learning method to increase ... lack is reported to impact on students negatively as they ... care systems and information technology have reduced .... skilled, they become more confident and more motivated .... for achieving long-term retention of clinical competency.

Improving clinical cognitive testing: report of the AAN Behavioral Neurology Section Workgroup.

Science.gov (United States)

Daffner, Kirk R; Gale, Seth A; Barrett, A M; Boeve, Bradley F; Chatterjee, Anjan; Coslett, H Branch; D'Esposito, Mark; Finney, Glen R; Gitelman, Darren R; Hart, John J; Lerner, Alan J; Meador, Kimford J; Pietras, Alison C; Voeller, Kytja S; Kaufer, Daniel I

2015-09-08

To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. © 2015 American Academy of Neurology.

Trichinella infection and clinical disease

DEFF Research Database (Denmark)

Clausen, M R; Meyer, C N; Krantz, T

1996-01-01

Trichinellosis is caused by ingestion of insufficiently cooked meat contaminated with infective larvae of Trichinella species. The clinical course is highly variable, ranging from no apparent infection to severe and even fatal disease. We report two illustrative cases of trichinellosis. Returning....... Life-threatening cardiopulmonary, renal and central nervous system complications developed. The patient recovered after several months. Her husband, who also ate the pork, did not have clinical symptoms, but an increased eosinophil count and a single larva in a muscle biopsy confirmed infection....... The epidemiology, clinical manifestations, diagnosis, treatment and prevention of trichinellosis are reviewed....

Extension Master Gardener Intranet: Automating Administration, Motivating Volunteers, Increasing Efficiency, and Facilitating Impact Reporting

Science.gov (United States)

Bradley, Lucy K.; Cook, Jonneen; Cook, Chris

2011-01-01

North Carolina State University has incorporated many aspects of volunteer program administration and reporting into an on-line solution that integrates impact reporting into daily program management. The Extension Master Gardener Intranet automates many of the administrative tasks associated with volunteer management, increasing efficiency, and…

Improving Bioscience Research Reporting: The ARRIVE Guidelines for Reporting Animal Research

Directory of Open Access Journals (Sweden)

Carol Kilkenny

2014-02-01

Full Text Available In the last decade the number of bioscience journals has increased enormously, with many filling specialised niches reflecting new disciplines and technologies. The emergence of open-access journals has revolutionised the publication process, maximising the availability of research data. Nevertheless, a wealth of evidence shows that across many areas, the reporting of biomedical research is often inadequate, leading to the view that even if the science is sound, in many cases the publications themselves are not “fit for purpose”, meaning that incomplete reporting of relevant information effectively renders many publications of limited value as instruments to inform policy or clinical and scientific practice [1–21]. A recent review of clinical research showed that there is considerable cumulative waste of financial resources at all stages of the research process, including as a result of publications that are unusable due to poor reporting [22]. It is unlikely that this issue is confined to clinical research [2–14,16–20].

Impact of a Clinical Decision Support System on Pharmacy Clinical Interventions, Documentation Efforts, and Costs

OpenAIRE

Calloway, Stacy; Akilo, Hameed A.; Bierman, Kyle

2013-01-01

Health care organizations are turning to electronic clinical decision support systems (CDSSs) to increase quality of patient care and promote a safer environment. A CDSS is a promising approach to the aggregation and use of patient data to identify patients who would most benefit from interventions by pharmacy clinicians. However, there are limited published reports describing the impact of CDSS on clinical pharmacy measures. In February 2011, Good Shepherd Medical Center, a 425-bed acute car...

Training clinicians in how to use patient-reported outcome measures in routine clinical practice

NARCIS (Netherlands)

Santana, Maria J.; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

2015-01-01

Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs

Clinical reasoning: concept analysis.

Science.gov (United States)

Simmons, Barbara

2010-05-01

This paper is a report of a concept analysis of clinical reasoning in nursing. Clinical reasoning is an ambiguous term that is often used synonymously with decision-making and clinical judgment. Clinical reasoning has not been clearly defined in the literature. Healthcare settings are increasingly filled with uncertainty, risk and complexity due to increased patient acuity, multiple comorbidities, and enhanced use of technology, all of which require clinical reasoning. Data sources. Literature for this concept analysis was retrieved from several databases, including CINAHL, PubMed, PsycINFO, ERIC and OvidMEDLINE, for the years 1980 to 2008. Rodgers's evolutionary method of concept analysis was used because of its applicability to concepts that are still evolving. Multiple terms have been used synonymously to describe the thinking skills that nurses use. Research in the past 20 years has elucidated differences among these terms and identified the cognitive processes that precede judgment and decision-making. Our concept analysis defines one of these terms, 'clinical reasoning,' as a complex process that uses cognition, metacognition, and discipline-specific knowledge to gather and analyse patient information, evaluate its significance, and weigh alternative actions. This concept analysis provides a middle-range descriptive theory of clinical reasoning in nursing that helps clarify meaning and gives direction for future research. Appropriate instruments to operationalize the concept need to be developed. Research is needed to identify additional variables that have an impact on clinical reasoning and what are the consequences of clinical reasoning in specific situations.

FAMILIAL AMYLOID POLYNEUROPATHY——CLINICAL REPORT OF A FAMILY

Institute of Scientific and Technical Information of China (English)

李延峰; 郭玉璞; 池田修一; 方定华

1996-01-01

This paper reports a familial amyloid polyneumpathy (FAP) family in China. This family being investigated had 69 members of five generations. From the third generation, there have been 16 patients. The age of onset was about 3 to 5 decades. The initial symptoms were autonomic nerve symptcans, such as impotence, dyspepaia and diarrhoea, associated with the sensory loss of lower extremities. As the disease progressed. the upper extremities and motor ability were also involved. The duration of disease course wasabout 8-10 years, most patients died of infection and cacbexia. Sural biopsy in 3 patients had showed positive Congo red staining. From the clinical view, this FAP family is similar to FAP I found in Japan. Thetrue classification, however, should be confirmed by further genetic analysis.

Recurrent Venous Thromboembolism as the Initial Clinical Presentation of Gastric Cancer: A Case Report

Directory of Open Access Journals (Sweden)

Fariba Rezaeetalab

2017-09-01

Full Text Available Pulmonary thromboembolism (PTE is a clinically critical disease, misdiagnosis or delayed diagnosis of which can lead to increased rate of mortality. For prevention of recurrence of PTE, recognition of its risk factors or underlying diseases is of great importance. PTE is common in patients with cancer and has high morbidity and mortality rates. Although cancer is a lethal condition, PTE accelerates death in these patients. In the current study, we reported the case of a 50-year-old male presenting with dyspnea, pleuritic chest pain, and non-massive hemoptysis indicating pulmonary embolism. Anticoagulant therapy was initiated, but after 12 days of treatment, new deep vein thromboses in the left upper and right lower limbs were diagnosed. However, no specific risk factors or laboratory abnormalities were detected. History of weight loss during the recent months encouraged further investigation for ruling out malignancy, which led a diagnosis of gastric adenocarcinoma. He did not have any complaints of gastrointestinal disorders.

The impact of patient-reported outcome measures in clinical practice for pain: a systematic review.

Science.gov (United States)

Holmes, Michelle M; Lewith, George; Newell, David; Field, Jonathan; Bishop, Felicity L

2017-02-01

Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain. An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument. Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive. Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains.

Quinolones Resistance And R-Plasmids Of Clinical Isolates Of ...

African Journals Online (AJOL)

Background: There has been reported incidence in the emergence of. Quinolones resistance in clinical isolates in Nigeria and the level in resistance has been on the increase. Objective: To determine the antimicrobial resistance patterns and plasmids profiles of 67 clinical Pseudomonas species from a teaching hospital ...

Clinical review: Riedel's thyroiditis: a clinical review.

Science.gov (United States)

Hennessey, James V

2011-10-01

Riedel's thyroiditis is a rare inflammatory process involving the thyroid and surrounding cervical tissues and is associated with various forms of systemic fibrosis. Riedel's presentation is complex, including a thyroid mass associated with local symptoms, characteristic biochemical abnormalities such as hypocalcemia and hypothyroidism, as well as the involvement of a wide range of other organ systems. Diagnosis of Riedel's thyroiditis requires histopathological confirmation, but due to high complication rates, the role of surgical intervention is limited to airway decompression and diagnostic tissue retrieval. Unique among processes of the thyroid, Riedel's is commonly treated with long-term antiinflammatory medications to arrest progression and maintain a symptom-free course. Due to its rarity, Riedel's may not be immediately diagnosed, so clinicians benefit from recognizing the constellation of findings that should make prompt diagnosis possible. A review of print and electronic reviews was conducted. Source references were identified, and available literature was reviewed. A search of the PubMed database using the search term "Riedel's thyroiditis" was cross-referenced with associated clinical findings, systemic fibrosis diagnoses, and therapeutic search terms. Because most of the literature consisted of case reports and very small series, inclusion of identified articles was based on clinical descriptions of the subjects included and the criteria for diagnosis reported. More weight was attributed to series, using contemporary criteria for diagnosis. Case reports were included if the diagnosis was clear and clinical presentation was unique to illustrate the spectrum of disease. Because the majority of therapeutic intervention data were based upon case reports and very small series, an evidence-based approach was problematic, but information is presented as objectively and with as much balance as the limited quality of the data allows. Clinical awareness of the

Miniplate for osteosynthesis in a 9-year-old with symphysis fracture: clinical report.

Science.gov (United States)

Srinivasan, Ila; Kumar, Naveen; Jaganathan, Udhya; Bhandari, Arihant

2013-09-01

Osteosynthesis using minimum material in pediatric mandibular fractures is the key, due to the limited space available in the mandible, especially in the mental foramen and apical region. There is an important role of open reduction and rigid internal fixation in re-establishing facial height, width and projection. During the early years of growth and development, there is a high osteogenic potential of the bones. The thick periosteum allows for rapid consolidation and remodeling at the site of fracture. Primary teeth have short, bulbous crowns which compromise stable maxillomandibular fixation during fracture reduction and stabilization using traditional methods. Further, stability of the fractured segments may be hampered because of the displaced or mobile permanent anterior teeth in the mixed dentition along the line of fracture. This clinical report outlines the use of miniplate with monocortical screws in a 9-year-old boy with symphysis fracture. How to cite this article: Srinivasan I, Kumar N, Jaganathan U, Bhandari A. Miniplate for Osteosynthesis in a 9-Year-Old with Symphysis Fracture: Clinical Report. Int J Clin Pediatr Dent 2013;6(3):213-216.

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

DEFF Research Database (Denmark)

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

2014-01-01

OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...... identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. SETTING: 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

Prosthetic rehabilitation of edentulous patient with limited oral access: A clinical report

Directory of Open Access Journals (Sweden)

Sandeep Kumar

2012-01-01

Full Text Available Microstomia may result from surgical treatment of orofacial neoplasms, cleft lips, maxillofacial trauma, burns, radiotherapy or scleroderma. A maximal oral opening that is smaller than the size of a complete denture can make prosthetic treatment challenging. This clinical report presents the prosthodontic management of a total edentulous patient with microstomia. Sectional mandibular and maxillary trays and foldable mandibular and maxillary denture were fabricated for the total edentulous patient.

Methadone patients exhibit increased startle and cortisol response after intravenous yohimbine.

Science.gov (United States)

Stine, S M; Grillon, C G; Morgan, C A; Kosten, T R; Charney, D S; Krystal, J H

2001-03-01

Brain noradrenergic systems have been shown to be altered in opioid dependence and to mediate aspects of opioid withdrawal. Pre-clinical and clinical studies by others have shown that yohimbine, which increases noradrenergic activity, also increases both baseline and fear enhancement of the magnitude of the acoustic startle response (ASR). In a separate report from this experiment, it was shown that yohimbine produced opioid withdrawal-like symptoms, including anxiety, in clinically stable methadone-maintained patients and also produced elevations in the norepinepherine (NE) metabolite, 3-methoxy-4 hydroxyphenethyleneglycol (MHPG), and cortisol serum levels. The current study reports the effects of intravenous yohimbine hydrochloride, 0.4 mg/kg versus saline (double-blind), on ASR magnitude, plasma MHPG, and cortisol levels in eight methadone-maintained patients and 13 healthy subjects in a double-blind fashion. Yohimbine increased startle magnitude in both groups. There was no basal (placebo day) difference between the startle response of the two groups, but methadone patients had a larger startle magnitude increase in response to yohimbine than healthy controls. Methadone-maintained patients had lower baseline plasma levels of MHPG and similar baseline plasma cortisol levels compared with normal subjects. Yohimbine caused significant elevation in cortisol and MHPG in both groups. Methadone-maintained subjects had higher elevations in cortisol levels and MHPG (methadone main effect) levels in response to yohimbine. However, when MHPG levels were corrected for baseline differences by analysis of covariance (ANCOVA), the yohimbine effect, but not the methadone effect remained statistically significant. These results are consistent with the previous report and support the hypothesis that abnormalities of the hypothalamic-pituitary-adrenal (HPA) axis and of noradrenergic mechanisms of stress response persist in opioid-agonist maintenance. The ASR effect extends the

The Critical Role of Early Dengue Surveillance and Limitations of Clinical Reporting - Implications for Non-Endemic Countries.

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Jui-Hung Kao

Full Text Available The increasing dengue burden and epidemic severity worldwide have highlighted the need to improve surveillance. In non-endemic areas such as Taiwan, where outbreaks start mostly with imported cases from Southeast Asia, a closer examination of surveillance dynamics to detect cases early is necessary. To evaluate problems with dengue surveillance and investigate the involvement of different factors at various epidemic stages, we investigated 632 laboratory-confirmed indigenous dengue cases in Kaohsiung City, Taiwan during 2009-2010. The estimated sensitivity of clinical surveillance was 82.4% (521/632. Initially, the modified serological surveillance (targeting only the contacts of laboratory-confirmed dengue cases identified clinically unrecognized afebrile cases in younger patients who visited private clinics and accounted for 30.4% (35/115 of the early-stage cases. Multivariate regression indicated that hospital/medical center visits [Adjusted Odds Ratio (aOR: 11.6, 95% confidence interval (CI: 6.3-21.4], middle epidemic stage [aOR: 2.4 (1.2-4.7], fever [aOR: 2.3 (2.3-12.9], and musculo-articular pain [aOR: 1.9 (1.05-3.3] were significantly associated with clinical reporting. However, cases with pruritus/rash [aOR: 0.47 (0.26-0.83] and diarrhea [aOR: 0.47 (0.26-0.85] were underreported. In conclusion, multiple factors contributed to dengue surveillance problems. To prevent a large-scale epidemic and minimize severe dengue cases, there is a need for integrated surveillance incorporating entomological, clinical, serological, and virological surveillance systems to detect early cases, followed by immediate prevention and control measures and continuous evaluation to ensure effectiveness. This effort will be particularly important for an arbovirus, such as Zika virus, with a high asymptomatic infection ratio. For dengue- non-endemic countries, we recommend serological surveillance be implemented in areas with high Aedes mosquito indices or many

Reports of past alcohol and drug use following participation in a motivation enhancing intervention: Implications for clinical assessment and program evaluation

Directory of Open Access Journals (Sweden)

Rosengren David B

2012-05-01

Full Text Available Abstract Background There is significant interest in the value of motivational approaches that enhance participant readiness to change, but less is known about clients’ self-reports of problematic behavior when participating in such interventions. Methods We examined whether participants in a motivationally-based intervention for DUI offenders changed their reports of substance use at postintervention (when reporting on the same 30 days that they reported on at preintervention. Specifically, Study 1 (N = 8,387 tested whether participants in PRIME For Life (PFL changed their reports about baseline substance levels when asked at postintervention versus at preintervention. Study 2 (N = 192 compared changes in self-reported baseline drinking between PFL and intervention as usual (IAU participants. Results Many participants in Study 1 did not change their reports about how much they used substances during the 30-day period before baseline. Among those who did, the most common change was an increase in reported amounts of baseline drug use, and typical and peak alcohol use. This sample also showed changes in reports of their baseline pattern of high-risk-use (consistent versus occasional. At postintervention, participants who were younger, single, or endorsing more indicators of alcohol dependence were more likely to later report greater frequency of baseline drug use, and greater peak and typical number of baseline drinks. Gender, education, and race were also associated with reporting inconsistency on some behaviors. In Study 2, PFL participants showed greater increases in reports of peak alcohol use compared to IAU, but both conditions showed similar increases for drugs and typical alcohol use. Conclusions In both research and clinical settings, a segment of participants may initially report less substance use than they do when asked later about the same baseline period. These preliminary findings suggest clinicians and researchers may

Mounier-Kuhn syndrome: radiological findings and clinical presentation

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Bastos, Andrea de Lima [Hospital Julia Kubitschek-FHEMIG, Belo Horizonte, MG (Brazil). Unidade de Diagnostico por Imagem; Brito, Isabela Lage Alves, E-mail: andblima@yahoo.com.b [Hospital Julia Kubitschek-FHEMIG, Belo Horizonte, MG (Brazil). Dept. de Pneumologia

2011-05-15

Mounier-Kuhn syndrome is a rare disease clinically characterized by recurrent respiratory infections. The present report describes a case of this disease with analysis of chest radiography and high resolution computed tomography showing increased caliber of the trachea, main bronchi and central bronchiectasis. Such changes, in association with clinical data, suggest the diagnosis. (author)

A marketing clinical doctorate programs.

Science.gov (United States)

Montoya, Isaac D; Kimball, Olive M

2007-01-01

Over the past decade, clinical doctorate programs in health disciplines have proliferated amid both support and controversy among educators, professional organizations, practitioners, administrators, and third-party payers. Supporters argue that the explosion of new knowledge and increasing sophistication of technology have created a need for advanced practice models to enhance patient care and safety and to reduce costs. Critics argue that necessary technological advances can be incorporated into existing programs and believe that clinical doctorates will increase health care costs, not reduce them. Despite the controversy, many health disciplines have advanced the clinical doctorate (the most recent is the doctor of nursing practice in 2004), with some professions mandating the doctorate as the entry-level degree (i.e., psychology, pharmacy, audiology, and so on). One aspect of the introduction of clinical doctoral degrees has been largely overlooked, and that is the marketing aspect. Because of marketing considerations, some clinical doctorates have been more successfully implemented and accepted than others. Marketing is composed of variables commonly known as "the four P's of marketing": product, price, promotion, and place. This report explores these four P's within the context of clinical doctorates in the health disciplines.

The natural history of conducting and reporting clinical trials: interviews with trialists.

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Smyth, Rebecca M D; Jacoby, Ann; Altman, Douglas G; Gamble, Carrol; Williamson, Paula R

2015-01-26

To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008. A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations. Our results confirm that the conduct and reporting of some trials can be inadequate. Interviews with researchers identified aspects of clinical research that can be especially challenging

Radiology clinical synopsis: a simple solution for obtaining an adequate clinical history for the accurate reporting of imaging studies on patients in intensive care units

International Nuclear Information System (INIS)

Cohen, Mervyn D.; Alam, Khurshaid

2005-01-01

Lack of clinical history on radiology requisitions is a universal problem. We describe a simple Web-based system that readily provides radiology-relevant clinical history to the radiologist reading radiographs of intensive care unit (ICU) patients. Along with the relevant history, which includes primary and secondary diagnoses, disease progression and complications, the system provides the patient's name, record number and hospital location. This information is immediately available to reporting radiologists. New clinical information is immediately entered on-line by the radiologists as they are reviewing images. After patient discharge, the data are stored and immediately available if the patient is readmitted. The system has been in routine clinical use in our hospital for nearly 2 years. (orig.)

Evidence and diagnostic reporting in the IHE context.

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Loef, Cor; Truyen, Roel

2005-05-01

Capturing clinical observations and findings during the diagnostic imaging process is increasingly becoming a critical step in diagnostic reporting. Standards developers-notably HL7 and DICOM-are making significant progress toward standards that enable exchanging clinical observations and findings among the various information systems of the healthcare enterprise. DICOM-like the HL7 Clinical Document Architecture (CDA) -uses templates and constrained, coded vocabulary (SNOMED, LOINC, etc.). Such a representation facilitates automated software recognition of findings and observations, intrapatient comparison, correlation to norms, and outcomes research. The scope of DICOM Structured Reporting (SR) includes many findings that products routinely create in digital form (measurements, computed estimates, etc.). In the Integrating the Healthcare Enterprise (IHE) framework, two Integration Profiles are defined for clinical data capture and diagnostic reporting: Evidence Document, and Simple Image and Numeric Report. This report describes these two DICOM SR-based integration profiles in the diagnostic reporting process.

Are self-report scales as effective as clinician rating scales in measuring treatment response in routine clinical practice?

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Zimmerman, Mark; Walsh, Emily; Friedman, Michael; Boerescu, Daniela A; Attiullah, Naureen

2018-01-01

Recent treatment guidelines have suggested that outcome should be measured in routine clinical practice. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we compared three self-report scales of depressive symptoms and the two most widely used clinician administered scales in treatment studies in their sensitivity to change and evaluation of treatment response in depressed patients treated in routine practice. At baseline and 4-month follow-up 153 depressed outpatients with DSM-IV MDD completed the Clinically Useful Depression Outcome Scale (CUDOS), Quick Inventory of Depressive Symptomatology-Self-report version (QIDS-SR), and Patient Health Questionnaire (PHQ-9). The patients were rated on the 17-item Hamilton Depression Rating Scale (HAMD) and the Montgomery-Asberg Depression Rating Scale (MADRS). On each scale treatment response was defined as a 50% or greater reduction in scores from baseline. While there were some differences in the percentage of patients considered to be responders on the different scales, a large effect size was found for each scale, with little variability amongst the scales. The level of agreement between the three self-report scales and the clinician rating scales was approximately the same LIMITATIONS: The present study was conducted in a single clinical practice in which the majority of the patients were white, female, and had health insurance. When measuring outcome in clinical practice the magnitude of change in depressive symptoms is as great on self-report scales as on clinician rating scales. Copyright © 2017 Elsevier B.V. All rights reserved.

Accuracy of Clinical Techniques for Evaluating Lower Limb Sensorimotor Functions Associated With Increased Fall Risk.

Science.gov (United States)

Donaghy, Alex; DeMott, Trina; Allet, Lara; Kim, Hogene; Ashton-Miller, James; Richardson, James K

2016-04-01

In prior work, laboratory-based measures of hip motor function and ankle proprioceptive precision were critical to maintaining unipedal stance and fall/fall-related injury risk. However, the optimal clinical evaluation techniques for predicting these measures are unknown. To evaluate the diagnostic accuracy of common clinical maneuvers in predicting laboratory-based measures of frontal plane hip rate of torque development (Hip(RTD)) and ankle proprioceptive thresholds (AnkPRO) associated with increased fall risk. Prospective, observational study. Biomechanical research laboratory. A total of 41 older subjects (aged 69.1 ± 8.3 years), 25 with varying degrees of diabetic distal symmetric polyneuropathy and 16 without. Clinical hip strength was evaluated by manual muscle testing (MMT) and lateral plank time, defined as the number of seconds that the laterally lying subject could lift the hips from the support surface. Foot/ankle evaluation included Achilles reflex and vibratory, proprioceptive, monofilament, and pinprick sensations at the great toe. Hip(RTD), abduction and adduction, using a custom whole-body dynamometer. AnkPRO determined with subjects standing using a foot cradle system and a staircase series of 100 frontal plane rotational stimuli. Pearson correlation coefficients (r) and receiver operator characteristic (ROC) curves revealed that LPT correlated more strongly with Hip(RTD) (r/P = 0.61/1.0°. LPT is a more effective measure of Hip(RTD) than MMT. Similarly, clinical vibratory sense and monofilament testing are effective measures of AnkPRO, whereas clinical proprioceptive sense is not. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Limitations in conduct and reporting of cochrane reviews rarely inhibit the determination of the validity of evidence for clinical decision-making.

Science.gov (United States)

Alper, Brian S; Fedorowicz, Zbys; van Zuuren, Esther J

2015-08-01

To determine how often clinical conclusions derived from Cochrane Reviews have uncertain validity due to review conduct and reporting deficiencies. We evaluated 5142 clinical conclusions in DynaMed (an evidence-based point-of-care clinical reference) based on 4743 Cochrane Reviews. Clinical conclusions with level 2 evidence due to shortcomings in the review's conduct or reporting (rather than deficiencies in the underlying evidence) were confirmed by a DynaMed editor and two Cochrane Review authors. Thirty-one Cochrane Reviews (0.65%) had confirmed deficiencies in conduct and reporting as the reason for classifying 37 assessed clinical conclusions (0.72%) as level 2 evidence. In all cases, it was not feasible for the assessors to specify a clear criticism of the studies included in the reviews. The deficiencies were specific to not accounting for dropouts (2) or inadequate assessment and reporting of allocation concealment (11), other specific trial quality criteria (14), or all trial quality criteria (4). Cochrane Reviews provide high-quality assessment and synthesis of evidence, with fewer than 1% of Cochrane Reviews having limitations which hinder the summary of best current evidence for clinical decision-making. We expect this will further decrease following recent Cochrane quality initiatives. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

Increase in tiagabine serum concentration with coadministration of gemfibrozil.

Science.gov (United States)

Burstein, Aaron H; Boudreau, Eilis A; Theodore, William H

2009-02-01

To report a case of possible acute tiagabine toxicity secondary to administration of gemfibrozil. A 39-year-old male was taking tiagabine 16 mg orally 3 times per day and carbamazepine 500 mg orally twice per day for complex partial seizures secondary to mesial temporal sclerosis. He was found to have type IV hypertriglyceridemia and was prescribed gemfibrozil. Because he reported severe confusion and altered consciousness shortly after a single 600-mg dose of gemfibrozil, he was admitted for controlled challenge with that drug. A single 300-mg dose of gemfibrozil resulted in lightheadedness and led to a 59% and 75% increase in total tiagabine serum concentrations at 2 and 5 hours, respectively, without significant change in baseline carbamazepine concentrations. This is the first report of an interaction between the widely used antihyperlipidemic drug gemfibrozil and tiagabine. Since tiagabine, which was originally developed as an antiepileptic medication, is now being used widely for a variety of other indications such as anxiety and depression, there is an increased risk for clinically significant interactions with gemfibrozil. Increased total and unbound tiagabine concentrations following a single 300-mg dose of gemfibrozil and reproduction of clinical symptoms with gemfibrozil rechallenge suggests the toxicity our patient experienced was due to a pharmacokinetic drug interaction. Use of the Horn Drug Interaction Probability Scale showed a probable interaction between gemfibrozil and tiagabine.

Patient-reported symptoms during radiotherapy. Clinically relevant symptom burden in patients treated with palliative and curative intent

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Koerner, Philipp [Universitaetsklinikum Wuerzburg, Interdisziplinaeres Zentrum Palliativmedizin, Wuerzburg (Germany); Universitaetsklinikum Wuerzburg, Klinik und Poliklinik fuer Strahlentherapie, Wuerzburg (Germany); Ehrmann, Katja [Universitaetsklinikum Wuerzburg, Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften, Wuerzburg (Germany); Hartmannsgruber, Johann [Praxis Landshut, Kinderzahnheilkunde, Landshut (Germany); Metz, Michaela; Steigerwald, Sabrina; Flentje, Michael [Universitaetsklinikum Wuerzburg, Klinik und Poliklinik fuer Strahlentherapie, Wuerzburg (Germany); Oorschot, Birgitt van [Universitaetsklinikum Wuerzburg, Interdisziplinaeres Zentrum Palliativmedizin, Wuerzburg (Germany)

2017-07-15

The benefits of patient-reported symptom assessment combined with integrated palliative care are well documented. This study assessed the symptom burden of palliative and curative-intent radiation oncology patients. Prior to first consultation and at the end of RT, all adult cancer patients planned to receive fractionated percutaneous radiotherapy (RT) were asked to answer the Edmonton Symptom Assessment Scale (ESAS; nine symptoms from 0 = no symptoms to 10 = worst possible symptoms). Mean values were used for curative vs. palliative and pre-post comparisons, and the clinical relevance was evaluated (symptom values ≥ 4). Of 163 participating patients, 151 patients (90.9%) completed both surveys (116 curative and 35 palliative patients). Before beginning RT, 88.6% of palliative and 72.3% of curative patients showed at least one clinically relevant symptom. Curative patients most frequently named decreased general wellbeing (38.6%), followed by tiredness (35.0%), anxiety (32.4%), depression (30.0%), pain (26.3%), lack of appetite (23.5%), dyspnea (17.8%), drowsiness (8.0%) and nausea (6.1%). Palliative patients most frequently named decreased general wellbeing (62.8%), followed by pain (62.8%), tiredness (60.0%), lack of appetite (40.0%), anxiety (38.0%), depression (33.3%), dyspnea (28.5%), drowsiness (25.7%) and nausea (14.2%). At the end of RT, the proportion of curative and palliative patients with a clinically relevant symptom had increased significantly to 79.8 and 91.4%, respectively; whereas the proportion of patients reporting clinically relevant pain had decreased significantly (42.8 vs. 62.8%, respectively). Palliative patients had significantly increased tiredness. Curative patients reported significant increases in pain, tiredness, nausea, drowsiness, lack of appetite and restrictions in general wellbeing. Assessment of patient-reported symptoms was successfully realized in radiation oncology routine. Overall, both groups showed a high symptom burden

[Clinical risk management in german hospitals - does size really matter?].

Science.gov (United States)

Bohnet-Joschko, S; Jandeck, L M; Zippel, C; Andersen, M; Krummenauer, F

2011-06-01

In the last years, German hospitals have implemented different measures to increase patient safety. Special importance has been attached to near miss reporting systems (critical incident reporting system, CIRS) as instruments for risk identification in health care, instruments that promise high potential for organisational learning. To gain insight into the current status of critical incident reporting systems and other instruments for clinical risk management, a survey among 341 hospitals was carried out in 2009. Questions covered a process of six steps: from risk strategy to methods for risk identification, to risk analysis and risk assessment, to risk controlling and risk monitoring. Structured telephone interviews were conducted with 341 German hospitals, featuring in their statutory quality reports certain predefined key terms that indicated the concluded or planned implementation of clinical risk management. The main objective of those interviews was to check the relation between status/organisation of self-reported risk management and both operator (private, public, NPO) and size of hospital. The implementation of near miss reporting systems (CIRS) in German hospitals has been constantly rising since 2004: in 2009, 54 % of the interviewed hospitals reported an implemented CIRS; of these, 72 % reported the system to be hospital-wide. An association between CIRS and private, public or NPO-operator could not be detected (Fisher p = 1.000); however, the degree of CIRS implementation was significantly increasing with the size of the hospital, i.e., the number of beds (Fisher p = 0.008): only 38 % of the hospitals with less than 100 beds reported CIRS implementation against 52 % of those between 100 to 500 beds, and 67 % of those with more than 500 beds. While 62 % of the hospitals interviewed reported the maintenance of a risk management committee, only 14 % reported the implementation of risk analysing techniques. As to clinical risk

Reports of chronic pain in childhood and adolescence among patients at a tertiary care pain clinic.

Science.gov (United States)

Hassett, Afton L; Hilliard, Paul E; Goesling, Jenna; Clauw, Daniel J; Harte, Steven E; Brummett, Chad M

2013-11-01

Although chronic pain in childhood can last into adulthood, few studies have evaluated the characteristics of adults with chronic pain who report childhood chronic pain. Thus, 1,045 new patients (mean age, 49.5 ± 15.4) at an academic tertiary care pain clinic were prospectively evaluated using validated self-report questionnaires. Patients also responded to questions about childhood pain. We found that almost 17% (n = 176) of adult chronic pain patients reported a history of chronic pain in childhood or adolescence, with close to 80% indicating that the pain in childhood continues today. Adults reporting childhood chronic pain were predominantly female (68%), commonly reported widespread pain (85%), and had almost 3 times the odds of meeting survey criteria for fibromyalgia (odds ratio [OR] = 2.94, 95% confidence interval [CI] = 2.04-4.23) than those denying childhood chronic pain. Similarly, those with childhood pain had twice the odds of having biological relatives with chronic pain (OR = 2.03, 95% CI = 1.39-2.96) and almost 3 times the odds of having relatives with psychiatric illness (OR = 2.85, 95% CI = 1.97-4.11). Lastly, compared to patients who did not report childhood chronic pain, those who did were more likely to use neuropathic descriptors for their pain (OR = 1.82, 95% CI = 1.26-2.64), have slightly worse functional status (B = -2.12, t = -3.10, P = .002), and have increased anxiety (OR = 1.77, 95% CI = 1.24-2.52). Our study revealed that 1 in 6 adult pain patients reported pain that dated back to childhood or adolescence. In such patients, evidence suggested that their pain was more likely to be widespread, neuropathic in nature, and accompanied by psychological comorbidities and decreased functional status. Copyright © 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.

Atypical presentation of HELLP syndrome: clinical case report

Directory of Open Access Journals (Sweden)

Juan Manuel Tobar Parra

2017-12-01

Full Text Available Objective: To describe a case of HELLP syndrome with atypical presentation form. Background: HELLP syndrome is a complication of preeclampsia, characterized by: haemolysis, elevation of liver enzymes and thrombocytopenia; Can present atypical, without hypertension or proteinuria, 10-20% of the cases. Case report: 38 year old female patient, with a pregnancy of 38.5 weeks of gestation, treated at the Hospital Universitario San José de Popayán (Colombia. Atypical HELLP syndrome is diagnosed in a pregnant woman with thrombocytopenia, impaired liver enzymes, but no evidence of proteinuria or hypertension. Gestation is terminated by cesarean section and magnesium sulfate is given for 24 hours, with adequate post-surgical evolution, clinical improvement of the symptomatology presented, normalization of liver enzymes and platelet elevation. Conclusion: Knowledge of this syndrome, although of rare occurrence, allows a fast action, an effective diagnosis and treatment, to avoid morbidity and greater maternal fetal mortality.

Combining Clinical Information and Patient Reported Outcome Measures in Orthopaedic Surgery and Sports Medicine

NARCIS (Netherlands)

Kampen, D.A. van

2013-01-01

In this thesis we investigated the use of clinical information and Patient Reported Outcome Measures (PROMs) for patient evaluation in orthopaedic surgery and sports medicine. In the first part, we showed that the Dutch version of the Simple Shoulder Test (SST) is a valid and reliable

The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications

DEFF Research Database (Denmark)

Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

2014-01-01

randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. RESULTS: Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8......%), reported compromised blinding; and 8 publications, or 3% (95% CI, 1, 5%), intact blinding. The reporting on risk of unblinding in the 24 trial publications was generally incomplete. The median proportion of assessments per trial affected by unblinding was 3% (range 1-30%). The most common mechanism...

Oral rehabilitation of a patient with amelogenesis imperfecta using removable overlay denture: a clinical report.

Science.gov (United States)

Ghodsi, S; Rasaeipour, S; Vojdani, M

2012-03-01

The aim of this study was oral rehabilitation of 17-year old patient with amelogenesis imperfecta using removable overlay denture in order to satisfy her esthetic and functional expectations and enhance her self-image. Amelogenesis imperfecta (AI) is a group of genetic disorders that primarily affect the quality and quantity of amelogenesis in both primary and permanent dentitions. The main clinical characteristics are severe attrition, tooth sensitivity and unesthetic appearance. This clinical report illustrates the oral rehabilitation of a 17-year-old girl with hypoplastic-hypomature type of AI with cobalt-chromium (Co-Cr) overlay removable partial denture (ORPD) that is one of the most economical and biocompatible replacements for noble metal and nickel-chromium (Ni-Cr) alloy. The presented case report suggests that Co-Cr ORPD can be a good temporary or even permanent treatment option for AI patients with limited budget, low esthetic concerns or medical limitations. There are major advantages in cast metal ORPDs; they are simpler, less traumatic and less expensive than fixed prosthetic options. This case report supports their use in patients with amelogenesis imperfecta.

Chemotherapy-Induced Peripheral Neuropathy in Long-term Survivors of Childhood Cancer: Clinical, Neurophysiological, Functional, and Patient-Reported Outcomes.

Science.gov (United States)

Kandula, Tejaswi; Farrar, Michelle Anne; Cohn, Richard J; Mizrahi, David; Carey, Kate; Johnston, Karen; Kiernan, Matthew C; Krishnan, Arun V; Park, Susanna B

2018-05-14

In light of the excellent long-term survival of childhood cancer patients, it is imperative to screen for factors affecting health, function, and quality of life in long-term survivors. To comprehensively assess chemotherapy-induced peripheral neuropathy in childhood cancer survivors to define disease burden and functional effect and to inform screening recommendations. In this cross-sectional observational study, cancer survivors who were treated with chemotherapy for extracranial malignancy before age 17 years were recruited consecutively between April 2015 and December 2016 from a single tertiary hospital-based comprehensive cancer survivorship clinic and compared with healthy age-matched controls. Investigators were blinded to the type of chemotherapy. A total of 169 patients met inclusion criteria, of whom 48 (28.4%) were unable to be contacted or declined participation. Chemotherapy agents known to be toxic to peripheral nerves. The clinical peripheral neurological assessment using the Total Neuropathy Score was compared between recipients of different neurotoxic chemotherapy agents and control participants and was correlated with neurophysiological, functional, and patient-reported outcome measures. Of the 121 childhood cancer survivors included in this study, 65 (53.7%) were male, and the cohort underwent neurotoxicity assessments at a median (range) age of 16 (7-47) years, a median (range) 8.5 (1.5-29) years after treatment completion. Vinca alkaloids and platinum compounds were the main neurotoxic agents. Clinical abnormalities consistent with peripheral neuropathy were common, seen in 54 of 107 participants (50.5%) treated with neurotoxic chemotherapy (mean Total Neuropathy Score increase, 2.1; 95% CI, 1.4-2.9; P neuropathy (mean amplitude reduction, 5.8 μV; 95% CI, 2.8-8.8; P Neuropathy Score. Cisplatin produced long-term neurotoxicity more frequently than vinca alkaloids. Clinical abnormalities attributable to peripheral neuropathy were common in

THE WAYS OF INCREASING OF QUALITY AND ACCESSIBILITY OF PEDIATRIC MEDICAL SERVICE IN OUT-PATIENT CLINICS

Directory of Open Access Journals (Sweden)

A.A. Baranov

2009-01-01

Full Text Available The analysis of dynamics of official statistics rates (population size, morbidity, disability, and mortality, and results of special scientific studies (morbidity, physical development, make it possible to show basic tendencies of children’s health state changes in modern conditions. The result of pediatrists from out-patient clinics survey, questioning of parents and adolescents (12–17 years old, on the problem of children’s health service, are presented. Questionnaire poll was held in regions of Central, Privolzhskiy, and Siberian Federal Districts. The complex analysis of obtained results show low quality level and accessibility of prophylactic and treatment medical service in children. This data became the basis of main directions of work of controlling and public health service in the field of increasing of quality and accessibility of pediatric medical service in out-patient clinics.Key words: children, medical service, out-patient clinics, quality, accessibility.(Voprosy sovremennoi pediatrii — Current Pediatrics. 2009;8(4:5-9

Implementation of the Kids-CAT in clinical settings: a newly developed computer-adaptive test to facilitate the assessment of patient-reported outcomes of children and adolescents in clinical practice in Germany.

Science.gov (United States)

Barthel, D; Fischer, K I; Nolte, S; Otto, C; Meyrose, A-K; Reisinger, S; Dabs, M; Thyen, U; Klein, M; Muehlan, H; Ankermann, T; Walter, O; Rose, M; Ravens-Sieberer, U

2016-03-01

To describe the implementation process of a computer-adaptive test (CAT) for measuring health-related quality of life (HRQoL) of children and adolescents in two pediatric clinics in Germany. The study focuses on the feasibility and user experience with the Kids-CAT, particularly the patients' experience with the tool and the pediatricians' experience with the Kids-CAT Report. The Kids-CAT was completed by 312 children and adolescents with asthma, diabetes or rheumatoid arthritis. The test was applied during four clinical visits over a 1-year period. A feedback report with the test results was made available to the pediatricians. To assess both feasibility and acceptability, a multimethod research design was used. To assess the patients' experience with the tool, the children and adolescents completed a questionnaire. To assess the clinicians' experience, two focus groups were conducted with eight pediatricians. The children and adolescents indicated that the Kids-CAT was easy to complete. All pediatricians reported that the Kids-CAT was straightforward and easy to understand and integrate into clinical practice; they also expressed that routine implementation of the tool would be desirable and that the report was a valuable source of information, facilitating the assessment of self-reported HRQoL of their patients. The Kids-CAT was considered an efficient and valuable tool for assessing HRQoL in children and adolescents. The Kids-CAT Report promises to be a useful adjunct to standard clinical care with the potential to improve patient-physician communication, enabling pediatricians to evaluate and monitor their young patients' self-reported HRQoL.

Basics of case report form designing in clinical research.

Science.gov (United States)

Bellary, Shantala; Krishnankutty, Binny; Latha, M S

2014-10-01

Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

T1- Thresholds in Black Holes Increase Clinical-Radiological Correlation in Multiple Sclerosis Patients.

Science.gov (United States)

Thaler, Christian; Faizy, Tobias; Sedlacik, Jan; Holst, Brigitte; Stellmann, Jan-Patrick; Young, Kim Lea; Heesen, Christoph; Fiehler, Jens; Siemonsen, Susanne

2015-01-01

increased by application of T1-RT thresholds. With the short acquisition time of the MP2RAGE sequences, quantitative T1 maps could be easily established in clinical studies.

A short-term increase in cancer risk associated with daytime napping is likely to reflect pre-clinical disease: prospective cohort study.

Science.gov (United States)

Cairns, B J; Travis, R C; Wang, X-S; Reeves, G K; Green, J; Beral, V

2012-07-24

Sleep disturbance, a correlate of which is daytime napping, has been hypothesised to be associated with risk of breast and other cancers. We estimated relative risks (RR) of breast and other invasive cancers by the reported frequency of daytime napping in a large prospective cohort of middle-aged women in the UK. During an average of 7.4 years of follow-up, 20 058 breast cancers and 31 856 other cancers were diagnosed. Over the first 4 years of follow-up, daytime napping (sometimes/usually vs rarely/never) was associated with slightly increased risks of breast cancer (RR=1.10, 95% CI 1.06-1.15) and of other cancers (RR=1.12, 1.08-1.15), but the RRs decreased significantly with increasing follow-up time (P=0.001 and P=0.01, respectively, for trend). Four or more years after baseline, there was no elevated risk of breast cancer (RR=1.00, 0.96-1.05), and only marginally greater risk of other cancers (RR=1.04, 1.01-1.07). The effect of pre-clinical disease is a likely explanation for the short-term increased risk of breast and other cancers associated with daytime napping. © 2012 Cancer Research UK

Case report: Suspected clinical-radiological discord

Directory of Open Access Journals (Sweden)

Martin Tombe

2013-02-01

Full Text Available 17-year male student presented with vague constitutional symptoms and jaundice. His clinical chest findings initially suggested a discord with radiological findings. It turned out that the patient had a rare congenital disorder in addition to a seemingly common condition that brought him to the hospital. The purpose of this case presentation is to share some challenges of a clinical-radiological discord in a teaching hospital in Zimbabwe. It shows a flow of teamwork from House Officers to the Consultants as well as radiological back up.

Disease awareness may increase risk of suicide in young onset dementia: A case report

Directory of Open Access Journals (Sweden)

Maria Alice Tourinho Baptista

Full Text Available ABSTRACT Studies report that people with young onset Alzheimer's disease (YOAD have higher levels of disease awareness compared to those with late onset AD. We report a case of a man with YOAD who had preserved awareness of disease, depression and risk of suicide associated with the development of the dementia. Cognitive functioning, disease severity, depressive symptoms and awareness of disease were assessed using validated measures. The person with YOAD showed a moderate level of disease severity and high degree of dependence for activities of daily living. There was recognition of memory problems and routine changes with presence of intense pessimism, low self-esteem and suicidal ideation. This case points to the existence of specific issues related to young onset dementia and the clinical importance of identifying and treating patients who might be aware of their condition.

Racial and ethnic variations in one-year clinical and patient-reported outcomes following breast reconstruction.

Science.gov (United States)

Berlin, Nicholas L; Momoh, Adeyiza O; Qi, Ji; Hamill, Jennifer B; Kim, Hyungjin M; Pusic, Andrea L; Wilkins, Edwin G

2017-08-01

Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

Antiphospholipid Syndrome Clinical Research Task Force Report

NARCIS (Netherlands)

Erkan, D.; Derksen, R.; Levy, R.; Machin, S.; Ortel, T.; Pierangeli, S.; Roubey, R.; Lockshin, M.

The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study

OpenAIRE

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

2014-01-01

Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical codi...

Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

Science.gov (United States)

Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

2005-09-01

To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

Brief strategic therapy in first myocardial infarction patients with increased levels of stress: a randomized clinical trial.

Science.gov (United States)

Rakowska, Jadwiga Małgorzata

2015-01-01

Little is known about the impact of interventions targeting chronic stress levels on clinical outcomes among myocardial infarction (MI) patients with increased levels of stress. To examine the impact of the addition of brief strategic therapy (BST) to usual care (UC) on clinical outcomes in first MI patients with increased levels of stress. Eighty-one patients were randomly assigned to BST in conjunction with UC (medical treatment, risk factor information, and guidance on unhealthy behavior change) or to UC. The outcome measures were scores on the Perceived Stress Scale, reinfarction and cardiac mortality rates, and scores on the Health Survey. Measures were taken before, post-treatment, and at two follow-ups. Patients subjected to BST showed reduced perceived stress at post-treatment and maintained decreased levels at follow-ups. At 1-year follow-up, they had a lower rate of non-fatal reinfarction, and at 2.5-year follow-up, they had a lower rate of fatal reinfarction. Their mental and physical health was improved at post-treatment and this was sustained at follow-ups. The addition of BST to UC favorably influences the disease course after MI in patients with increased levels of stress.

Self-reported musculoskeletal pain predicts long-term increase in general health care use

DEFF Research Database (Denmark)

Hartvigsen, Jan; Davidsen, Michael; Søgaard, Karen

2014-01-01

reported during the past two weeks from the Danish National Cohort Study were merged with data from the Danish National Health Insurance Registry and the National Patient Registry containing information on consultations in the Danish primary and secondary care sector. Absolute and relative rates for all......Aims: Musculoskeletal pain and disability is a modern epidemic and a major reason for seeking health care. The aim of this study is to determine absolute and relative rates of care seeking over 20 years for adults reporting musculoskeletal complaints. Methods: Interview data on musculoskeletal pain...... to any of the outcomes. CONCLUSIONS SELF-REPORT OF MUSCULOSKELETAL PAIN REPORTED WITHIN THE PAST TWO WEEKS PREDICTS A STATISTICALLY SIGNIFICANT LONG-TERM INCREASE IN GENERAL USE OF HEALTH CARE SERVICES IN BOTH THE PRIMARY AND THE SECONDARY HEALTH CARE SECTOR:...

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital.

Science.gov (United States)

Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg

2014-12-01

Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of

Perception matters for clinical perfectionism and social anxiety.

Science.gov (United States)

Levinson, Cheri A; Rodebaugh, Thomas L; Shumaker, Erik A; Menatti, Andrew R; Weeks, Justin W; White, Emily K; Heimberg, Richard G; Warren, Cortney S; Blanco, Carlos; Schneier, Franklin; Liebowitz, Michael R

2015-01-01

Despite research documenting a relationship between social anxiety and perfectionism, very little research has examined the relationship between social anxiety and clinical perfectionism, defined as the combination of high personal standards and high maladaptive perfectionistic evaluative concern. In the current studies we examined whether clinical perfectionism predicted social anxiety in a large sample of undergraduates (N=602), in a clinical sample of participants diagnosed with social anxiety disorder (SAD; N=180), and by using a variance decomposition model of self- and informant-report of perfectionism (N=134). Using self-report, we found that an interaction of personal standards and evaluative concern predicted both social interaction anxiety and fear of scrutiny, but not in the theorized direction. Specifically, we found that self-report of low standards and high evaluative concern was associated with the highest levels of social anxiety, suggesting that when individuals with SAD hold low expectations for themselves combined with high concerns about evaluation, social anxiety symptoms may increase. Alternatively, when an informants' perspective was considered, and more consistent with the original theory, we found that the interaction of informant-only report of personal standards and shared-report (between both primary participant and informant) of concern over mistakes was associated with self-reported social anxiety, such that high concern over mistakes and high personal standards predicted the highest levels of social anxiety. Theoretical, clinical, and measurement implications for clinical perfectionism are discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.

A National Radiation Oncology Medical Student Clerkship Survey: Didactic Curricular Components Increase Confidence in Clinical Competency

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Jagadeesan, Vikrant S. [Department of Radiation and Cellular Oncology, Pritzker School of Medicine, University of Chicago, Chicago, Illinois (United States); Raleigh, David R. [Department of Radiation Oncology, School of Medicine, University of California–San Francisco, San Francisco, California (United States); Koshy, Matthew; Howard, Andrew R.; Chmura, Steven J. [Department of Radiation and Cellular Oncology, Pritzker School of Medicine, University of Chicago, Chicago, Illinois (United States); Golden, Daniel W., E-mail: dgolden@radonc.uchicago.edu [Department of Radiation and Cellular Oncology, Pritzker School of Medicine, University of Chicago, Chicago, Illinois (United States)

2014-01-01

Purpose: Students applying to radiation oncology residency programs complete 1 or more radiation oncology clerkships. This study assesses student experiences and perspectives during radiation oncology clerkships. The impact of didactic components and number of clerkship experiences in relation to confidence in clinical competency and preparation to function as a first-year radiation oncology resident are evaluated. Methods and Materials: An anonymous, Internet-based survey was sent via direct e-mail to all applicants to a single radiation oncology residency program during the 2012-2013 academic year. The survey was composed of 3 main sections including questions regarding baseline demographic information and prior radiation oncology experience, rotation experiences, and ideal clerkship curriculum content. Results: The survey response rate was 37% (70 of 188). Respondents reported 191 unique clerkship experiences. Of the respondents, 27% (19 of 70) completed at least 1 clerkship with a didactic component geared towards their level of training. Completing a clerkship with a didactic component was significantly associated with a respondent's confidence to function as a first-year radiation oncology resident (Wilcoxon rank–sum P=.03). However, the total number of clerkships completed did not correlate with confidence to pursue radiation oncology as a specialty (Spearman ρ P=.48) or confidence to function as a first year resident (Spearman ρ P=.43). Conclusions: Based on responses to this survey, rotating students perceive that the majority of radiation oncology clerkships do not have formal didactic curricula. Survey respondents who completed a clerkship with a didactic curriculum reported feeling more prepared to function as a radiation oncology resident. However, completing an increasing number of clerkships does not appear to improve confidence in the decision to pursue radiation oncology as a career or to function as a radiation oncology resident. These

A national radiation oncology medical student clerkship survey: didactic curricular components increase confidence in clinical competency.

Science.gov (United States)

Jagadeesan, Vikrant S; Raleigh, David R; Koshy, Matthew; Howard, Andrew R; Chmura, Steven J; Golden, Daniel W

2014-01-01

Students applying to radiation oncology residency programs complete 1 or more radiation oncology clerkships. This study assesses student experiences and perspectives during radiation oncology clerkships. The impact of didactic components and number of clerkship experiences in relation to confidence in clinical competency and preparation to function as a first-year radiation oncology resident are evaluated. An anonymous, Internet-based survey was sent via direct e-mail to all applicants to a single radiation oncology residency program during the 2012-2013 academic year. The survey was composed of 3 main sections including questions regarding baseline demographic information and prior radiation oncology experience, rotation experiences, and ideal clerkship curriculum content. The survey response rate was 37% (70 of 188). Respondents reported 191 unique clerkship experiences. Of the respondents, 27% (19 of 70) completed at least 1 clerkship with a didactic component geared towards their level of training. Completing a clerkship with a didactic component was significantly associated with a respondent's confidence to function as a first-year radiation oncology resident (Wilcoxon rank-sum P=.03). However, the total number of clerkships completed did not correlate with confidence to pursue radiation oncology as a specialty (Spearman ρ P=.48) or confidence to function as a first year resident (Spearman ρ P=.43). Based on responses to this survey, rotating students perceive that the majority of radiation oncology clerkships do not have formal didactic curricula. Survey respondents who completed a clerkship with a didactic curriculum reported feeling more prepared to function as a radiation oncology resident. However, completing an increasing number of clerkships does not appear to improve confidence in the decision to pursue radiation oncology as a career or to function as a radiation oncology resident. These results support further development of structured didactic

A National Radiation Oncology Medical Student Clerkship Survey: Didactic Curricular Components Increase Confidence in Clinical Competency

International Nuclear Information System (INIS)

Jagadeesan, Vikrant S.; Raleigh, David R.; Koshy, Matthew; Howard, Andrew R.; Chmura, Steven J.; Golden, Daniel W.

2014-01-01

Purpose: Students applying to radiation oncology residency programs complete 1 or more radiation oncology clerkships. This study assesses student experiences and perspectives during radiation oncology clerkships. The impact of didactic components and number of clerkship experiences in relation to confidence in clinical competency and preparation to function as a first-year radiation oncology resident are evaluated. Methods and Materials: An anonymous, Internet-based survey was sent via direct e-mail to all applicants to a single radiation oncology residency program during the 2012-2013 academic year. The survey was composed of 3 main sections including questions regarding baseline demographic information and prior radiation oncology experience, rotation experiences, and ideal clerkship curriculum content. Results: The survey response rate was 37% (70 of 188). Respondents reported 191 unique clerkship experiences. Of the respondents, 27% (19 of 70) completed at least 1 clerkship with a didactic component geared towards their level of training. Completing a clerkship with a didactic component was significantly associated with a respondent's confidence to function as a first-year radiation oncology resident (Wilcoxon rank–sum P=.03). However, the total number of clerkships completed did not correlate with confidence to pursue radiation oncology as a specialty (Spearman ρ P=.48) or confidence to function as a first year resident (Spearman ρ P=.43). Conclusions: Based on responses to this survey, rotating students perceive that the majority of radiation oncology clerkships do not have formal didactic curricula. Survey respondents who completed a clerkship with a didactic curriculum reported feeling more prepared to function as a radiation oncology resident. However, completing an increasing number of clerkships does not appear to improve confidence in the decision to pursue radiation oncology as a career or to function as a radiation oncology resident. These results

Clinically lesser known entity in India: A Report of two cases of Melioidosis.

Science.gov (United States)

Barman, Purabi; Kaur, Ravneet; Kumar, Kamlesh

2013-01-01

Melioidosis is endemic in the South Asian regions, like Thailand, Singapore Malaysia and Australia. The disease is more pronounced in the southern part of the country. It is caused by Burkholderia pseudomallei which causes systemic involvement, morbidity and mortality associated with the disease is high. Due to highly varied clinical presentation, and low general awareness this infection is largely underdiagnosed and under reported in our country. Most laboratories in the country still rely on conventional culturing methods with their low sensitivity, adding to the under reporting. To enhance physician awareness we describe here two cases who presented to our institute after months of misdiagnosis.

A clinical protocol to increase chewing and assess mastication in children with feeding disorders.

Science.gov (United States)

Volkert, Valerie M; Peterson, Kathryn M; Zeleny, Jason R; Piazza, Cathleen C

2014-09-01

Children with feeding disorders often cannot or do not chew when presented with table food. Children with chewing deficits also often swallow the bite before masticating it appropriately, which we will refer to as early swallowing. In the current study, we evaluated a clinical protocol to increase chews per bite, assess mastication, and eliminate early swallowing with three children with feeding disorders. The current study adds to a small body of literature on chewing and mastication of children with feeding disorders. Suggestions for future research are also discussed. © The Author(s) 2014.

[Detection of Weissella spp. in milk samples of two dairy cows with clinical mastitis. A case report].

Science.gov (United States)

Wald, Regina; Baumgartner, Martina; Urbantke, Verena; Wittek, Thomas; Stessl, Beatrix

2016-10-12

This case report describes the isolation and differentiation of Weissella (W.) spp. from the milk of two cows (A and B) with clinical mastitis (milk changes, asymmetry of the udder and increased somatic cell counts). Quarter milk samples obtained from two dairy cows of different farms had been submitted to the diagnostic laboratory of the Clinic for Ruminants in Vienna for bacteriological examination. Alpha-hemolytic catalase-negative gram-positive cocci in pure culture on Columbia blood agar were isolated and could not be assigned to a Lancefield group. The isolates were biochemically characterized as Leuconostoc spp. (API ® 20 Strep, bioMérieux). A control examination of cow B within 7 weeks confirmed these findings. 16S rDNA sequencing indicated W. paramesenteroides (cow A) and W. cibaria (cow B). The analysis by pulsed-field gel electrophoresis (PFGE) showed identical SmaI/ApaI profiles for both W. cibaria isolates (cow B), which differed from the W. paramesenteroides fingerprint of cow A (67% similarity). This study indicates a possible relationship between the detection of Weissella spp. and the occurrence of bovine intramammary infections.

Clinical physiology grand rounds.

Science.gov (United States)

Richards, Jeremy; Schwartzstein, Richard; Irish, Julie; Almeida, Jacqueline; Roberts, David

2013-04-01

Clinical Physiology Grand Rounds (CPGR) is an interactive, case-based conference for medical students designed to: (1) integrate preclinical and clinical learning; (2) promote inductive clinical reasoning; and (3) emphasise students as peer teachers. CPGR specifically encourages mixed learning level student interactions and emphasises the use of concept mapping. We describe the theoretical basis and logistical considerations for an interactive, integrative, mixed-learner environment such as CPGR. In addition, we report qualitative data regarding students' attitudes towards and perceptions of CPGR. Medical students from first to fourth year participate in a monthly, interactive conference. The CPGR was designed to bridge gaps and reinforce linkages between basic science and clinical concepts, and to incorporate interactive vertical integration between preclinical and clinical students. Medical education and content experts use Socratic, interactive teaching methods to develop real-time concept maps to emphasise the presence and importance of linkages across curricula. Student focus groups were held to assess attitudes towards and perceptions of the mixed-learner environment and concept maps in CPGR. Qualitative analyses of focus group transcripts were performed to develop themes and codes describing the students' impressions of CPGR. CPGR is a case-based, interactive conference designed to help students gain an increased appreciation of linkages between basic science and clinical medicine concepts, and an increased awareness of clinical reasoning thought processes. Success is dependent upon explicit attention being given to goals for students' integrated learning. © Blackwell Publishing Ltd 2013.

Critical value reporting: a survey of 36 clinical laboratories in South Africa.

Science.gov (United States)

Schapkaitz, Elise; Mafika, Zipho

2013-10-11

Critical value policies are used by clinical laboratories to decide when to notify caregivers of life-threatening results. Despite their widespread use, critical value policies have not been published locally. A survey was designed to determine critical value policies for haematology tests in South Africa. A survey was carried out on 136 identified laboratories across South Africa in January 2013. Of these, 36 responded. Data collected included critical value policies, critical values for haematology parameters, and critical value reporting. Of the 36 laboratories surveyed, 11.1% (n=4) were private, 33.3% (n=12) were affiliated to academic institutions and 55.6% (n=20) were peripheral or regional National Health Laboratory Service laboratories. All the laboratories confirmed that they had a critical value policy, and 83.3% of such policies were derived from local clinical opinion. Mean low and high critical limits for the most frequently listed tests were as follows: haemoglobin 20 g/dl, platelet count 1 000 ×10(9)/l, white cell count 46 ×10(9)/l, activated partial thromboplastin time >101 seconds, and international normalised ratio >6. In almost all cases critical value reporting was performed by the technologist on duty (97.2%). The majority of laboratories required that the person notified of the critical value be the doctor who ordered the test or the caregiver directly involved in the patient's care (83.3%); 73.3% of laboratories indicated that they followed an algorithm if the doctor/caregiver could not be reached. Each laboratory is responsible for establishing clinically relevant critical limits. Clinicians should be involved in developing the laboratory's critical value policy. The findings of this survey may be of value to local laboratories that are in the process of establishing or reviewing critical value policies.

Retinal layer location of increased retinal thickness in eyes with subclinical and clinical macular edema in diabetes type 2

DEFF Research Database (Denmark)

Bandello, Francesco; Tejerina, Amparo Navea; Vujosevic, Stela

2015-01-01

PURPOSE: To identify the retinal layer predominantly affected in eyes with subclinical and clinical macular edema in diabetes type 2. METHODS: A cohort of 194 type 2 diabetic eyes/patients with mild nonproliferative diabetic retinopathy (ETDRS levels 20/35) were examined with Cirrus spectral......-domain optical coherence tomography (OCT) at the baseline visit (ClinicalTrials.gov identifier: NCT01145599). Automated segmentation of the retinal layers of the eyes with subclinical and clinical macular edema was compared with a sample of 31 eyes from diabetic patients with normal OCT and an age......-matched control group of 58 healthy eyes. RESULTS: From the 194 eyes in the study, 62 had subclinical macular edema and 12 had clinical macular edema. The highest increases in retinal thickness (RT) were found in the inner nuclear layer (INL; 33.6% in subclinical macular edema and 81.8% in clinical macular edema...

Brain lateralization and self-reported symptoms of ADHD in non-clinical adults : A dimensional approach

NARCIS (Netherlands)

Mohamed, Saleh M. H.; Borger, Norbertus; Geuze, Reint; van der Meere, Jacob

2015-01-01

Many clinical studies reported a compromised Brain Lateralization (BL) in patients with Attention-Deficit/Hyperactivity Disorder (ADHD). However, the question remains whether the deficit is in the left or right hemisphere. It is well-recognized that research on patients is vulnerable to

Social media release increases dissemination of original articles in the clinical pain sciences.

Science.gov (United States)

Allen, Heidi G; Stanton, Tasha R; Di Pietro, Flavia; Moseley, G Lorimer

2013-01-01

A barrier to dissemination of research is that it depends on the end-user searching for or 'pulling' relevant knowledge from the literature base. Social media instead 'pushes' relevant knowledge straight to the end-user, via blogs and sites such as Facebook and Twitter. That social media is very effective at improving dissemination seems well accepted, but, remarkably, there is no evidence to support this claim. We aimed to quantify the impact of social media release on views and downloads of articles in the clinical pain sciences. Sixteen PLOS ONE articles were blogged and released via Facebook, Twitter, LinkedIn and ResearchBlogging.org on one of two randomly selected dates. The other date served as a control. The primary outcomes were the rate of HTML views and PDF downloads of the article, over a seven-day period. The critical result was an increase in both outcome variables in the week after the blog post and social media release. The mean ± SD rate of HTML views in the week after the social media release was 18±18 per day, whereas the rate during the other three weeks was no more than 6±3 per day. The mean ± SD rate of PDF downloads in the week after the social media release was 4±4 per day, whereas the rate during the other three weeks was less than 1±1 per day (psocial media reach, engagement or virality related to either outcome variable, nor to citation count one year later (p>0.3 for all). We conclude that social media release of a research article in the clinical pain sciences increases the number of people who view or download that article, but conventional social media metrics are unrelated to the effect.

Social media release increases dissemination of original articles in the clinical pain sciences.

Directory of Open Access Journals (Sweden)

Heidi G Allen

Full Text Available A barrier to dissemination of research is that it depends on the end-user searching for or 'pulling' relevant knowledge from the literature base. Social media instead 'pushes' relevant knowledge straight to the end-user, via blogs and sites such as Facebook and Twitter. That social media is very effective at improving dissemination seems well accepted, but, remarkably, there is no evidence to support this claim. We aimed to quantify the impact of social media release on views and downloads of articles in the clinical pain sciences. Sixteen PLOS ONE articles were blogged and released via Facebook, Twitter, LinkedIn and ResearchBlogging.org on one of two randomly selected dates. The other date served as a control. The primary outcomes were the rate of HTML views and PDF downloads of the article, over a seven-day period. The critical result was an increase in both outcome variables in the week after the blog post and social media release. The mean ± SD rate of HTML views in the week after the social media release was 18±18 per day, whereas the rate during the other three weeks was no more than 6±3 per day. The mean ± SD rate of PDF downloads in the week after the social media release was 4±4 per day, whereas the rate during the other three weeks was less than 1±1 per day (p0.3 for all. We conclude that social media release of a research article in the clinical pain sciences increases the number of people who view or download that article, but conventional social media metrics are unrelated to the effect.

The impact of Medicaid-linked reimbursements on revenues of public sexually transmitted disease clinics.

Science.gov (United States)

Downey, Lois; Lafferty, William E; Krekeler, Barbara

2002-02-01

Public sexually transmitted disease (STD) clinics faced with decreased tax revenue and increased costs must evaluate alternative revenue sources. To report one public STD clinic's Medicaid-linked revenue and discuss the association between system characteristics and reimbursement potential. This was a cross-sectional study of 4208 patients visiting the clinic for new problems during a 6-month period. Of 458 Medicaid-enrolled patients, only 55% acknowledged enrollment at the time of visit. The clinic captured revenue for many of the remaining 45% through a centralized public health information/billing system, which submitted retroactive STD clinic claims when patients self-reported Medicaid enrollment at later visits to other public health clinics. These belated self-reports also contributed to Medicaid administrative-match reimbursements. An estimated $100,000 (31% of the clinic's direct reimbursements for service) would have been lost in 2000, had detection of Medicaid enrollment been based exclusively on patients' self-reports at STD clinic visits.

Clinical diagnosis and treatment of necrotizing ulcerative gingivitis in the orthodontic patient. A case report.

Directory of Open Access Journals (Sweden)

Jesús Rodríguez-Pulido

2016-04-01

Full Text Available Introduction: About 0.1% of the population suffers from necrotizing ulcerative gingivitis, a disease of rapid progression and acute manifestation, which may progress to necrotizing ulcerative periodontitis and eventually to bone sequestration and loss of gingival tissue. Case report: A 21-year-old female patient undergoing orthodontic treatment for six months, diagnosed with necrotizing ulcerative gingivitis due to acute pain in the gingival tissue, spontaneous bleeding, halitosis and abundant plaque. The treatment was conservative and effective, obtaining total remission of the lesion after seven days and three months of postoperative follow-up. Conclusion: Today there are no epidemiological or clinical reports that support the relationship of necrotizing ulcerative gingivitis and orthodontic treatment. Prevention is critical to the success of the treatment, which is why the dentist should recognize the clinical features of necrotizing ulcerative gingivitis to raise awareness of its risks in the orthodontic patient.

Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

OpenAIRE

Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN

2014-01-01

Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6?7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting par...

Web-based oil immersion whole slide imaging increases efficiency and clinical team satisfaction in hematopathology tumor board

Science.gov (United States)

Chen, Zhongchuan Will; Kohan, Jessica; Perkins, Sherrie L.; Hussong, Jerry W.; Salama, Mohamed E.

2014-01-01

Background: Whole slide imaging (WSI) is widely used for education and research, but is increasingly being used to streamline clinical workflow. We present our experience with regard to satisfaction and time utilization using oil immersion WSI for presentation of blood/marrow aspirate smears, core biopsies, and tissue sections in hematology/oncology tumor board/treatment planning conferences (TPC). Methods: Lymph nodes and bone marrow core biopsies were scanned at ×20 magnification and blood/marrow smears at 83X under oil immersion and uploaded to an online library with areas of interest to be displayed annotated digitally via web browser. Pathologist time required to prepare slides for scanning was compared to that required to prepare for microscope projection (MP). Time required to present cases during TPC was also compared. A 10-point evaluation survey was used to assess clinician satisfaction with each presentation method. Results: There was no significant difference in hematopathologist preparation time between WSI and MP. However, presentation time was significantly less for WSI compared to MP as selection and annotation of slides was done prior to TPC with WSI, enabling more efficient use of TPC presentation time. Survey results showed a significant increase in satisfaction by clinical attendees with regard to image quality, efficiency of presentation of pertinent findings, aid in clinical decision-making, and overall satisfaction regarding pathology presentation. A majority of respondents also noted decreased motion sickness with WSI. Conclusions: Whole slide imaging, particularly with the ability to use oil scanning, provides higher quality images compared to MP and significantly increases clinician satisfaction. WSI streamlines preparation for TPC by permitting prior slide selection, resulting in greater efficiency during TPC presentation. PMID:25379347

Web-based oil immersion whole slide imaging increases efficiency and clinical team satisfaction in hematopathology tumor board

Directory of Open Access Journals (Sweden)

Zhongchuan Will Chen

2014-01-01

Full Text Available Background: Whole slide imaging (WSI is widely used for education and research, but is increasingly being used to streamline clinical workflow. We present our experience with regard to satisfaction and time utilization using oil immersion WSI for presentation of blood/marrow aspirate smears, core biopsies, and tissue sections in hematology/oncology tumor board/treatment planning conferences (TPC. Methods: Lymph nodes and bone marrow core biopsies were scanned at ×20 magnification and blood/marrow smears at 83X under oil immersion and uploaded to an online library with areas of interest to be displayed annotated digitally via web browser. Pathologist time required to prepare slides for scanning was compared to that required to prepare for microscope projection (MP. Time required to present cases during TPC was also compared. A 10-point evaluation survey was used to assess clinician satisfaction with each presentation method. Results: There was no significant difference in hematopathologist preparation time between WSI and MP. However, presentation time was significantly less for WSI compared to MP as selection and annotation of slides was done prior to TPC with WSI, enabling more efficient use of TPC presentation time. Survey results showed a significant increase in satisfaction by clinical attendees with regard to image quality, efficiency of presentation of pertinent findings, aid in clinical decision-making, and overall satisfaction regarding pathology presentation. A majority of respondents also noted decreased motion sickness with WSI. Conclusions: Whole slide imaging, particularly with the ability to use oil scanning, provides higher quality images compared to MP and significantly increases clinician satisfaction. WSI streamlines preparation for TPC by permitting prior slide selection, resulting in greater efficiency during TPC presentation.

Closed-eye orbital prosthesis: a clinical report.

Science.gov (United States)