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.

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...

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.

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.

Prevalence of estimated GFR reporting among US clinical laboratories.

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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.

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...

Changes in clinical and hotel expenditures following publication of the nursing home compare report card.

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Mukamel, Dana B; Spector, William D; Zinn, Jacqueline; Weimer, David L; Ahn, Richard

2010-10-01

Nursing Home Compare first published clinical quality measures at the end of 2002. It is a quality report card that for the first time offers consumers easily accessible information about the clinical quality of nursing homes. It led to changes in consumers' demand, increasing the relative importance of clinical versus hotel aspects of quality in their search and choice of a nursing home. To examine the hypothesis that nursing homes responding to these changes in demand shifted the balance of resources from hotel to clinical activities. The study included 10,022 free-standing nursing homes nationwide during 2001 to 2006. RESEARCH DESIGN AND DATA: A retrospective multivariate statistical analysis of trends in the ratio of clinical to hotel expenditures, using Medicare cost reports, Minimum Data Set and Online Survey, Certification and Reporting data, controlling for changes in residents' acuity and facility fixed effects. Inference is based on robust standard errors. The ratio of clinical to hotel expenditures averaged 1.78. It increased significantly (P hotel expenditures following publication of the report card suggests that nursing homes responded as expected to the changes in the elasticity of demand with respect to clinical quality brought about by the public reporting of clinical quality measures. The response was stronger among nursing homes facing stronger incentives.

Clinical exome sequencing reports: current informatics practice and future opportunities.

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Swaminathan, Rajeswari; Huang, Yungui; Astbury, Caroline; Fitzgerald-Butt, Sara; Miller, Katherine; Cole, Justin; Bartlett, Christopher; Lin, Simon

2017-11-01

The increased adoption of clinical whole exome sequencing (WES) has improved the diagnostic yield for patients with complex genetic conditions. However, the informatics practice for handling information contained in whole exome reports is still in its infancy, as evidenced by the lack of a common vocabulary within clinical sequencing reports generated across genetic laboratories. Genetic testing results are mostly transmitted using portable document format, which can make secondary analysis and data extraction challenging. This paper reviews a sample of clinical exome reports generated by Clinical Laboratory Improvement Amendments-certified genetic testing laboratories at tertiary-care facilities to assess and identify common data elements. Like structured radiology reports, which enable faster information retrieval and reuse, structuring genetic information within clinical WES reports would help facilitate integration of genetic information into electronic health records and enable retrospective research on the clinical utility of WES. We identify elements listed as mandatory according to practice guidelines but are currently missing from some of the clinical reports, which might help to organize the data when stored within structured databases. We also highlight elements, such as patient consent, that, although they do not appear within any of the current reports, may help in interpreting some of the information within the reports. Integrating genetic and clinical information would assist the adoption of personalized medicine for improved patient care and outcomes. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Human reporter genes: potential use in clinical studies

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Serganova, Inna [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Ponomarev, Vladimir [Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Blasberg, Ronald [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States)], E-mail: blasberg@neuro1.mskcc.org

2007-10-15

The clinical application of positron-emission-tomography-based reporter gene imaging will expand over the next several years. The translation of reporter gene imaging technology into clinical applications is the focus of this review, with emphasis on the development and use of human reporter genes. Human reporter genes will play an increasingly more important role in this development, and it is likely that one or more reporter systems (human gene and complimentary radiopharmaceutical) will take leading roles. Three classes of human reporter genes are discussed and compared: receptors, transporters and enzymes. Examples of highly expressed cell membrane receptors include specific membrane somatostatin receptors (hSSTrs). The transporter group includes the sodium iodide symporter (hNIS) and the norepinephrine transporter (hNET). The endogenous enzyme classification includes human mitochondrial thymidine kinase 2 (hTK2). In addition, we also discuss the nonhuman dopamine 2 receptor and two viral reporter genes, the wild-type herpes simplex virus 1 thymidine kinase (HSV1-tk) gene and the HSV1-tk mutant (HSV1-sr39tk). Initial applications of reporter gene imaging in patients will be developed within two different clinical disciplines: (a) gene therapy and (b) adoptive cell-based therapies. These studies will benefit from the availability of efficient human reporter systems that can provide critical monitoring information for adenoviral-based, retroviral-based and lenteviral-based gene therapies, oncolytic bacterial and viral therapies, and adoptive cell-based therapies. Translational applications of noninvasive in vivo reporter gene imaging are likely to include: (a) quantitative monitoring of gene therapy vectors for targeting and transduction efficacy in clinical protocols by imaging the location, extent and duration of transgene expression; (b) monitoring of cell trafficking, targeting, replication and activation in adoptive T-cell and stem/progenitor cell therapies

Human reporter genes: potential use in clinical studies

International Nuclear Information System (INIS)

Serganova, Inna; Ponomarev, Vladimir; Blasberg, Ronald

2007-01-01

The clinical application of positron-emission-tomography-based reporter gene imaging will expand over the next several years. The translation of reporter gene imaging technology into clinical applications is the focus of this review, with emphasis on the development and use of human reporter genes. Human reporter genes will play an increasingly more important role in this development, and it is likely that one or more reporter systems (human gene and complimentary radiopharmaceutical) will take leading roles. Three classes of human reporter genes are discussed and compared: receptors, transporters and enzymes. Examples of highly expressed cell membrane receptors include specific membrane somatostatin receptors (hSSTrs). The transporter group includes the sodium iodide symporter (hNIS) and the norepinephrine transporter (hNET). The endogenous enzyme classification includes human mitochondrial thymidine kinase 2 (hTK2). In addition, we also discuss the nonhuman dopamine 2 receptor and two viral reporter genes, the wild-type herpes simplex virus 1 thymidine kinase (HSV1-tk) gene and the HSV1-tk mutant (HSV1-sr39tk). Initial applications of reporter gene imaging in patients will be developed within two different clinical disciplines: (a) gene therapy and (b) adoptive cell-based therapies. These studies will benefit from the availability of efficient human reporter systems that can provide critical monitoring information for adenoviral-based, retroviral-based and lenteviral-based gene therapies, oncolytic bacterial and viral therapies, and adoptive cell-based therapies. Translational applications of noninvasive in vivo reporter gene imaging are likely to include: (a) quantitative monitoring of gene therapy vectors for targeting and transduction efficacy in clinical protocols by imaging the location, extent and duration of transgene expression; (b) monitoring of cell trafficking, targeting, replication and activation in adoptive T-cell and stem/progenitor cell therapies

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

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Odgaard, Eric C; Fowler, Robert L

2010-06-01

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

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

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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.

Best clinical trials reported in 2010.

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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.

Importance of placebo effect in cough clinical trials.

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Eccles, Ron

2010-01-01

Cough is a unique symptom because, unlike sneeze and other symptoms, it can be under voluntary control and this complicates clinical trials on cough medicines. All over-the-counter cough medicines (OTC) are very effective treatments because of their placebo effect. The placebo effect is enhanced by expectancy related to advertising, brand, packaging, and formulation. This placebo effect creates a problem for the conduct of clinical trials on OTC cough medicines that attempt to demonstrate the efficacy of a pharmacological agent above that of any placebo effect. Up to 85% of the efficacy of some cough medicines can be attributed to a placebo effect. The placebo effect apparent in clinical trials consists of several components: natural recovery, regression of cough response toward mean, demulcent effect, effect of sweetness, voluntary control, and effects related to expectancy and meaning of the treatment. The placebo effect has been studied most in the pain model, and placebo analgesia is reported to depend on the activation of endogenous opioid systems in the brain; this model may be applicable to cough. A balanced placebo design may help to control for the placebo effect, but this trial design may not be acceptable due to deception of patients. The placebo effect in clinical trials may be controlled by use of a crossover design, where feasible, and the changes in the magnitude of the placebo effect in this study design are discussed.

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.

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

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

Science.gov (United States)

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

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

Directory of Open Access Journals (Sweden)

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.

Childhood bruxism: a clinical review and case report.

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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.

First report of oligodendroglioma in a sheep : clinical communication

Directory of Open Access Journals (Sweden)

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.

Electronic clinical safety reporting system: a benefits evaluation.

Science.gov (United States)

Elliott, Pamela; Martin, Desmond; Neville, Doreen

2014-06-11

Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

How are growth hormone and insulin-like growth factor-1 reported as markers for drug effectiveness in clinical acromegaly research? A comprehensive methodologic review

NARCIS (Netherlands)

Van Esdonk, Michiel J.; Van Zutphen, Eline J. M.; Roelfsema, Ferdinand; Pereira, Alberto M.; Van Der Graaf, Piet H.; Biermasz, Nienke R.; Stevens, Jasper; Burggraaf, Jacobus

2018-01-01

Objective. In rare disease research, most randomized prospective clinical trials can only use limited number of patients and are comprised of highly heterogeneous populations. Therefore, it is crucial to report the results in such a manner that it allows for comparison of treatment effectiveness and

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.

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....

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.

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.

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

Science.gov (United States)

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

2013-07-01

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

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

Science.gov (United States)

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

2017-08-01

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

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 ...

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

Science.gov (United States)

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

2016-01-01

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

Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

Science.gov (United States)

Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

2015-11-01

To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

Effect of immersive workplace experience on undergraduate nurses' mental health clinical confidence.

Science.gov (United States)

Patterson, Christopher; Moxham, Lorna; Taylor, Ellie K; Perlman, Dana; Brighton, Renee; Sumskis, Susan; Heffernan, Tim; Lee-Bates, Benjamin

2017-12-01

Preregistration education needs to ensure that student nurses are properly trained with the required skills and knowledge, and have the confidence to work with people who have a mental illness. With increased attention on non-traditional mental health clinical placements, further research is required to determine the effects of non-traditional mental health clinical placements on mental health clinical confidence. The aim of the present study was to investigate the impact of a non-traditional mental health clinical placement on mental health nursing clinical confidence compared to nursing students undergoing traditional clinical placements. Using the Mental Health Nursing Clinical Confidence Scale, the study investigated the relative effects of two placement programmes on the mental health clinical confidence of 79 nursing students. The two placement programmes included a non-traditional clinical placement of Recovery Camp and a comparison group that attended traditional clinical placements. Overall, the results indicated that, for both groups, mental health placement had a significant effect on improving mean mental health clinical confidence, both immediately upon conclusion of placement and at the 3-month follow up. Students who attended Recovery Camp reported a significant positive difference, compared to the comparison group, for ratings related to communicating effectively with clients with a mental illness, having a basic knowledge of antipsychotic medications and their side-effects, and providing client education regarding the effects and side-effects of medications. The findings suggest that a unique clinical placement, such as Recovery Camp, can improve and maintain facets of mental health clinical confidence for students of nursing. © 2017 Australian College of Mental Health Nurses Inc.

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.

Effectiveness of manual therapies: the UK evidence report

OpenAIRE

Bronfort, Gert; Haas, Mitch; Evans, Roni; Leininger, Brent; Triano, Jay

2010-01-01

Abstract Background The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. Methods The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet incl...

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.

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...

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

Science.gov (United States)

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

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

Science.gov (United States)

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

Effects of reiki in clinical practice: a systematic review of randomised clinical trials.

Science.gov (United States)

Lee, M S; Pittler, M H; Ernst, E

2008-06-01

The aim of this systematic review is to summarise and critically evaluate the evidence for the effectiveness of reiki. We searched the literature using 23 databases from their respective inceptions through to November 2007 (search again 23 January 2008) without language restrictions. Methodological quality was assessed using the Jadad score. The searches identified 205 potentially relevant studies. Nine randomised clinical trials (RCTs) met our inclusion criteria. Two RCTs suggested beneficial effects of reiki compared with sham control on depression, while one RCT did not report intergroup differences. For pain and anxiety, one RCT showed intergroup differences compared with sham control. For stress and hopelessness a further RCT reported effects of reiki and distant reiki compared with distant sham control. For functional recovery after ischaemic stroke there were no intergroup differences compared with sham. There was also no difference for anxiety between groups of pregnant women undergoing amniocentesis. For diabetic neuropathy there were no effects of reiki on pain. A further RCT failed to show the effects of reiki for anxiety and depression in women undergoing breast biopsy compared with conventional care. In total, the trial data for any one condition are scarce and independent replications are not available for each condition. Most trials suffered from methodological flaws such as small sample size, inadequate study design and poor reporting. In conclusion, the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore the value of reiki remains unproven.

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.

Methylene blue for clinical anaphylaxis treatment: a case report

Directory of Open Access Journals (Sweden)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

2017-01-01

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

Effect of clinical information in brain CT scan interpretation : a blinded double crossover study

International Nuclear Information System (INIS)

Zhianpour, M.; Janghorbani, M.

2004-01-01

Errors and variations in interpretation can happen in clinical imaging. Few studies have examined the biased effect of clinical information on reporting of brain CT scans. In a blinded double crossover design, we studied whether three radiologists were biased by clinical information when making CT scan diagnosis of the brain. Three consultant radiologists in three rounds with at least a one month interval assessed 100 consecutive cases of brain CT scan. In the first round, clinical information was not available and 100 films without clinical information were given to radiologists. In the second round, the same 100 films were given and true clinical information was available. In the third round, the same 100 films were given and false clinical information was allocated. In 180 cases (60%) the evaluation resulted in the same diagnosis on all three occasions (95% confidence interval (CI): 54.5, 65.5), whereas 120(40%; 95% CI:34.5, 45.5) sets were evaluated differently. 48 cases (16%; 95% CI:11.9,20.1) had discordant evaluation with true and 33 (11%; 95% CI:7.5, 14.5) with false clinical information. Discordance without and with true and false clinical information was 39 (13%; 95% CI:9.2, 16.8). Correct clinical information improves the brain CT report, while the report became less accurate false clinical information was allocated. These results indicate that radiologists are biased by clinical information when reporting brian CT scans

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.

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.

Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

Science.gov (United States)

Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

2012-10-01

Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

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...

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

Science.gov (United States)

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.

Science.gov (United States)

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.

Evidence of the clinical effectiveness of cognitive pharmaceutical services for aged patients.

Science.gov (United States)

Sáez-Benito, Loreto; Fernandez-Llimos, Fernando; Feletto, Eleonora; Gastelurrutia, Miguel Angel; Martinez-Martinez, Fernando; Benrimoj, Shalom I

2013-07-01

cognitive pharmaceutical services (CPSs) encompass a variety of pharmacists' interventions to optimise pharmacotherapy. The clinical effectiveness of CPSs for aged patients remains controversial. to analyse and describe the evidence of the clinical effectiveness of CPSs in aged patients by means of performing a systematic review of systematic reviews. using the recommended methodology by Cochrane, a search was undertaken for systematic reviews of the clinical effectiveness of CPSs in MEDLINE, EMBASE, DOAJ, SCIELO and COCHRANE LIBRARY. Reviews were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) instrument. Quality of the evidence in the reviews was ranked using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. a total of 14 systematic reviews and one meta-analysis were analysed. The overall quality of the reviews was moderate. High and moderate strength of evidence was found for the positive effect of certain CPSs on reducing the number and improving the appropriateness of medicines. There was conflicting evidence of the effect on adherence. There was limited evidence of high and moderate strength on clinical outcomes. No positive evidence was found on mortality, hospitalisations, functional capacity and cognitive function. No systematic reviews reported the effect on the level of control of health problems. certain types of CPSs reduce the number of medicines and improve the appropriateness of prescriptions. Longer follow-up periods and/or the use of surrogate clinical variables measuring the short-term impact are required to demonstrate the effect on clinical outcomes.

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

Design and Effectiveness of a Required Pre-Clinical Simulation-based Curriculum for Fundamental Clinical Skills and Procedures

Directory of Open Access Journals (Sweden)

Daryl P. Lofaso

2011-12-01

Full Text Available For more than 20 years, medical literature has increasingly documented the need for students to learn, practice and demonstrate competence in basic clinical knowledge and skills. In 2001, the Louisiana State University Health Science Centers (LSUHSC School of Medicine – New Orleans replaced its traditional Introduction in to Clinical Medicine (ICM course with the Science and Practice of Medicine (SPM course. The main component within the SPM course is the Clinical Skills Lab (CSL. The CSL teaches 30 plus skills to all pre-clinical medical students (Years 1 and 2. Since 2002, an annual longitudinal evaluation questionnaire was distributed to all medical students targeting the skills taught in the CSL. Students were asked to rate their self- confidence (Dreyfus and Likert-type and estimate the number of times each clinical skill was performed (clinically/non-clinically. Of the 30 plus skills taught, 8 were selected for further evaluation. An analysis was performed on the eight skills selected to determine the effectiveness of the CSL. All students that participated in the CSL reported a significant improvement in self-confidence and in number performed in the clinically/non-clinically setting when compared to students that did not experience the CSL. For example, without CSL training, the percentage of students reported at the end of their second year self-perceived expertise as “novice” ranged from 21.4% (CPR to 84.7% (GU catheterization. Students who completed the two-years CSL, only 7.8% rated their self-perceived expertise at the end of the second year as “novice” and 18.8% for GU catheterization. The CSL design is not to replace real clinical patient experiences. It's to provide early exposure, medial knowledge, professionalism and opportunity to practice skills in a patient free environment.

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...

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

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

Science.gov (United States)

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.

Clinical Case Reporting in the Peer-Reviewed Physical Therapy Literature: Time to Move Toward Functioning.

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Davenport, Todd E

2015-12-01

Physical therapists increasingly are contributing clinical case reports to the health literature, which form the basis for higher quality evidence that has been incorporated into clinical practice guidelines. Yet, few resources exist to assist physical therapists with the basic mechanics and quality standards of producing a clinical case report. This situation is further complicated by the absence of uniform standards for quality in case reporting. The importance of including a concise yet comprehensive description of patient functioning in all physical therapy case reports suggest the potential appropriateness of basing quality guidelines on the World Health Organization's International Classification of Functioning Disability and Health (ICF) model. The purpose of this paper is to assist physical therapists in creating high-quality clinical case reports for the peer-reviewed literature using the ICF model as a guiding framework. Along these lines, current recommendations related to the basic mechanics of writing a successful clinical case report are reviewed, as well and a proposal for uniform clinical case reporting requirements is introduced with the aim to improve the quality and feasibility of clinical case reporting in physical therapy that are informed by the ICF model. Copyright © 2013 John Wiley & Sons, Ltd.

Clinical findings and effect of sodium hydrogen carbonate in patients with glutathione synthetase deficiency.

Science.gov (United States)

Gündüz, Mehmet; Ünal, Özlem; Kavurt, Sumru; Türk, Emrecan; Mungan, Neslihan Önenli

2016-04-01

Glutathione synthetase (GS) deficiency is a rare inborn error of glutathione (GSH) metabolism manifested by severe metabolic acidosis, hemolytic anemia, neurological problems and massive excretion of pyroglutamic acid (5-oxoproline) in the urine. The disorder has mild, moderate, and severe clinical variants. We aimed to report clinical and laboratory findings of four patients, effect of sodium hydrogen carbonate treatment and long-term follow up of three patients. Urine organic acid analysis was performed with gas chromatography-mass spectrometry. Molecular genetic analysis was performed in three patients, mutation was found in two of them. Enzyme analysis was performed in one patient. Clinical and laboratory findings of four patients were evaluated. One patient died at 4 months old, one patient's growth and development are normal, two patients have developed intellectual disability and seizures in the long term follow up period. Three patients benefited from sodium hydrogen carbonate treatment. The clinical picture varies from patient to patient, so it is difficult to predict the prognosis and the effectiveness of treatment protocols. We reported long term follow up of four patients and demonstrated that sodium hydrogen carbonate is effective for treatment of chronic metabolic acidosis in GS deficieny.

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...

Placebo interventions for all clinical conditions

DEFF Research Database (Denmark)

Hróbjartsson, Asbjørn; Gøtzsche, Peter C

2010-01-01

Placebo interventions are often claimed to substantially improve patient-reported and observer-reported outcomes in many clinical conditions, but most reports on effects of placebos are based on studies that have not randomised patients to placebo or no treatment. Two previous versions of this re...... of this review from 2001 and 2004 found that placebo interventions in general did not have clinically important effects, but that there were possible beneficial effects on patient-reported outcomes, especially pain. Since then several relevant trials have been published.......Placebo interventions are often claimed to substantially improve patient-reported and observer-reported outcomes in many clinical conditions, but most reports on effects of placebos are based on studies that have not randomised patients to placebo or no treatment. Two previous versions...

Report of the Task Force on Clinical Research in Dentistry.

Science.gov (United States)

Journal of Dental Education, 1994

1994-01-01

A report on clinical dental research reviews current conditions and makes recommendations for increased funding, improved peer review for research proposals, establishment of a well-defined training track for clinical researchers, and better institutional integration of and support for research and teaching. Projected need for researchers is also…

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

DEFF Research Database (Denmark)

Ellegaard, Mai Britt Bjørklund; Grau, Cai; Zachariae, Robert

2017-01-01

effects were hot flushes (35%), fatigue (32%), and sleep disturbance (31%). CONCLUSION: None of the scheduled or additional visits resulted in detection of recurrent disease. Furthermore, the majority of patients reported side or late effects. Statistically significant more women reported side or late...... effects than registered by the clinical oncologists. This suggests the need for rethinking of the follow-up programs with more emphasis upon side or late effects of the treatment....

'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

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.

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.

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.

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

Science.gov (United States)

Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

2017-09-18

Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

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...

Clinical efficacy and effectiveness of 3D printing: a systematic review.

Science.gov (United States)

Diment, Laura E; Thompson, Mark S; Bergmann, Jeroen H M

2017-12-21

To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields. Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses. PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar. A double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study. Of the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy. All medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are

Communicating clinical trial outcomes: Effects of presentation method on physicians' evaluations of new treatments

Directory of Open Access Journals (Sweden)

Francesco Marcatto

2013-01-01

Full Text Available Physicians expect a treatment to be more effective when its clinical outcomes are described as relative rather than as absolute risk reductions. We examined whether effects of presentation method (relative vs. absolute risk reduction remain when physicians are provided the baseline risk information, a vital piece of statistical information omitted in previous studies. Using a between-subjects design, ninety five physicians were presented the risk reduction associated with a fictitious treatment for hypertension either as an absolute risk reduction or as a relative risk reduction, with or without including baseline risk information. Physicians reported that the treatment would be more effective and that they would be more willing to prescribe it when its risk reduction was presented to them in relative rather than in absolute terms. The relative risk reduction was perceived as more effective than absolute risk reduction even when the baseline risk information was explicitly reported. We recommend that information about absolute risk reduction be made available to physicians in the reporting of clinical outcomes. Moreover, health professionals should be cognizant of the potential biasing effects of risk information presented in relative risk terms.

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 effect of platelet rich fibrin in the treatment of periodontal intrabony defects. Systematic review and meta-analysis.

Directory of Open Access Journals (Sweden)

Heber Arbildo.

2017-05-01

Full Text Available Background: There is currently no gold standard biomaterial for the treatment of periodontal intrabony defects (PIDs. One of the current options is the use of platelet-rich fibrin (PRF. Objective: To determine the clinical effect of PRF in the treatment of PID through a systematic review and meta-analysis. Materials and Methods: A literature search was conducted up to February 2017 in the following biomedical databases: Pubmed, Embase, Scielo, Science Direct, SIGLE, LILACS and in the Cochrane Central Register of Clinical Trials. The selection criteria included: randomized clinical trials published in the last 5 years, reporting clinical effects (probing depth, clinical insertion level or gingival recession, with a follow-up time equal to or greater than 6 months, and sample size larger than or equal to 10 patients reporting the use of PRF as a treatment for PID. The methodological quality of the studies was analyzed using the Cochrane Handbook of Systematic Reviews of Interventions as a reference. Results: The search strategy yielded 20 articles. A reduction in probing depth and an increase in clinical insertion level or a reduction in gingival recession is reported, when using PRF alone or in combination with another biomaterial or substance that stimulates tissue regeneration. Conclusion: The literature suggests that the use of PRF in the treatment of PIDs has a beneficial clinical effect when compared to control treatments.

Effect of response format for clinical vignettes on reporting quality of physician practice

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Durieux Pierre

2009-07-01

Full Text Available Abstract Background Clinical vignettes have been used widely to compare quality of clinical care and to assess variation in practice, but the effect of different response formats has not been extensively evaluated. Our objective was to compare three clinical vignette-based survey response formats – open-ended questionnaire (A, closed-ended (multiple-choice questionnaire with deceptive response items mixed with correct items (B, and closed-ended questionnaire with only correct items (C – in rheumatologists' pre-treatment assessment for tumor-necrosis-factor (TNF blocker therapy. Methods Study design: Prospective randomized study. Setting: Rheumatologists attending the 2004 French Society of Rheumatology meeting. Physicians were given a vignette describing the history of a fictitious woman with active rheumatoid arthritis, who was a candidate for therapy with TNF blocking agents, and then were randomized to receive questionnaire A, B, or C, each containing the same four questions but with different response formats, that asked about their pretreatment assessment. Measurements: Long (recommended items and short (mandatory items checklists were developed for pretreatment assessment for TNF-blocker therapy, and scores were expressed on the basis of responses to questionnaires A, B, and C as the percentage of respondents correctly choosing explicit items on these checklists. Statistical analysis: Comparison of the selected items using pairwise Chi-square tests with Bonferonni correction for variables with statistically significant differences. Results Data for all surveys distributed (114 As, 118 Bs, and 118 Cs were complete and available for analysis. The percentage of questionnaire A, B, and C respondents for whom data was correctly complete for the short checklist was 50.4%, 84.0% and 95.0%, respectively, and was 0%, 5.0% and 5.9%, respectively, for the long version. As an example, 65.8%, 85.7% and 95.8% of the respondents of A, B, and C

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

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.

Report on Provider-Client Interaction From 68 Methadone Maintenance Clinics in China.

Science.gov (United States)

Li, Li; Comulada, W Scott; Lin, Chunqing; Lan, Chiao-Wen; Cao, Xiaobin; Wu, Zunyou

2017-11-01

Provider-client interaction is an integral of clinical practice and central to the delivery of high-quality medical care. This article examines factors related to the provider-client interaction in the context of methadone maintenance treatment (MMT). Data were collected from 68 MMT clinics in China. In total, 418 service providers participated in the survey. Linear mixed effects regression models were performed to identify factors associated with provider-client interaction. It was observed that negative attitude toward drug users was associated with lower level of provider-client interaction and less time spent with each client. Other factors associated with lower level of interaction included being female, being younger, being a nurse, and fewer years in medical field. Higher provider-client interaction was associated with provider reported job satisfaction. The findings of this study call for a need to address provider negative attitudes that can impact provider-client interaction and the effectiveness of MMT. Future intervention efforts targeting MMT providers should be tailored by gender, provider type, and medical experiences.

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...

Intraductal papillary mucinous neoplasms of the pancreas: reporting clinically relevant features.

Science.gov (United States)

Del Chiaro, Marco; Verbeke, Caroline

2017-05-01

Intraductal papillary mucinous neoplasms (IPMNs) of the pancreas can exhibit a wide spectrum of macroscopic and microscopic appearances. This not only causes occasional difficulties for the reporting pathologist in distinguishing these tumours from other lesions, but is also relevant clinically. As evidence accumulates, it becomes clear that multiple macroscopic and histological features of these neoplasms are relevant to the risk for malignant transformation and, consequently, of prime importance for clinical patient management. The need for detailed reporting is therefore increasing. This review discusses the panoply of gross and microscopic features of IPMN as well as the recommendations from recent consensus meetings regarding the pathology reporting on this tumour entity. © 2016 John Wiley & Sons Ltd.

Atypical presentation of HELLP syndrome: clinical case report

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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.

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...

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

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.

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...

Preclinical and Clinical Effects of Mistletoe against Breast Cancer

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Mohsen Marvibaigi

2014-01-01

Full Text Available Breast cancer is among the most frequent types of cancer in women worldwide. Current conventional treatment options are accompanied by side effects. Mistletoe is amongst the important herbal medicines traditionally used as complementary remedies. An increasing number of studies have reported anticancer activity of mistletoe extracts on breast cancer cells and animal models. Some recent evidence suggests that cytotoxic activity of mistletoe may be mediated through different mechanisms. These findings provide a good base for clinical trials. Various studies on mistletoe therapy for breast cancer patients revealed similar findings concerning possible benefits on survival time, health-related quality of life (HRQoL, remission rate, and alleviating adverse reactions to conventional therapy. This review provides an overview of the recent findings on preclinical experiments and clinical trials of mistletoe for its cytotoxic and antitumor activity and its effect on HRQoL in breast cancer patients. Moreover, studies investigating molecular and cellular mechanisms underlying antitumor activity of mistletoe are discussed in this paper. The analyzed trials provided evidence that there might be a combination of pharmacological and motivational aspects mediated by the mistletoe extract application which may contribute to the clinical benefit and positive outcome such as improved HRQoL and self-regulation in breast cancer patients.

Clinical diagnosis and treatment of necrotizing ulcerative gingivitis in the orthodontic patient. A case report.

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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.

Using Local Grammar for Entity Extraction from Clinical Reports

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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%.

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

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.

Clinical effectiveness and cost effect analysis of quadrivalent HPV vaccine

OpenAIRE

Lekić, Nataša

2008-01-01

1 ABSTRACT Quadrivalent Human Papillomavirus Vaccine- Evaluation of clinical effectiveness and national vaccine programs Author: Nataša Lekić Research Advisor: PharmDr. Lenka Práznovcová, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University in Prague. SUMMARY QUADRIVALENT HPV VACCINE- EVALUATION OF CLINICAL EFFECTIVENESS AND NATIONAL VACCINE PROGRAMS Background: Human papillomavirus types 6, 11,16 and 18 cause majority of genital warts an...

Clinical effect of platelet rich plasma in the treatment of periodontal intrabony defects.Systematic review and meta-analysis.

Directory of Open Access Journals (Sweden)

Heber Arbildo

2017-04-01

Full Text Available Introduction: One of the consequences of periodontitis is periodontal intrabony defects (PID. Various biomaterials have been used for its treatment, but there is still no biomaterial considered as the gold standard. Current research is focused on the use of platelet-rich plasma (PRP for the treatment of PID. Objective: To determine the clinical effect of PRP in the treatment of PID through a systematic review with meta-analysis. Materials and Methods: A literature search was conducted until February 2017 in the biomedical databases: Pubmed, Embase, Scielo, Science Direct, SIGLE, LILACS, IBECS, and the Cochrane Central Register of Clinical Trials. The criteria for the selection of the studies, which were randomized clinical trials, were the following: articles or papers published in the last 5 years, reporting clinical effects, with a follow-up time equal to or greater than 6 months, and a sample size equal to or greater than 10 patients reporting the use of PRP as a treatment for PID. The methodological quality of the studies was analyzed using the Cochrane Handbook of Systematic Reviews of Interventions as a reference. Results: The search strategy yielded nine articles reporting a reduction in probing depth and gingival recession, and an increase in clinical insertion level when using PRP alone or in combination with another biomaterial. Conclusion: The reviewed literature suggests that the use of PRP in the treatment of PID has a positive clinical effect.

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.

Clinical Data Warehouse: An Effective Tool to Create Intelligence in Disease Management.

Science.gov (United States)

Karami, Mahtab; Rahimi, Azin; Shahmirzadi, Ali Hosseini

Clinical business intelligence tools such as clinical data warehouse enable health care organizations to objectively assess the disease management programs that affect the quality of patients' life and well-being in public. The purpose of these programs is to reduce disease occurrence, improve patient care, and decrease health care costs. Therefore, applying clinical data warehouse can be effective in generating useful information about aspects of patient care to facilitate budgeting, planning, research, process improvement, external reporting, benchmarking, and trend analysis, as well as to enable the decisions needed to prevent the progression or appearance of the illness aligning with maintaining the health of the population. The aim of this review article is to describe the benefits of clinical data warehouse applications in creating intelligence for disease management programs.

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.

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…

Combining radiotherapy and ipilimumab induces clinically relevant radiation-induced abscopal effects in metastatic melanoma patients: A systematic review

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Rodolfo Chicas-Sett

2018-02-01

Conclusion: Early clinical outcomes reports suggest that the combination of ipilimumab and RT may improve survival in metastatic melanoma patients. The abscopal responses become a clinically relevant effect of such combination and should be studied in controlled randomized trials.

Quality Improvement in Pediatric Endoscopy: A Clinical Report From the NASPGHAN Endoscopy Committee.

Science.gov (United States)

Kramer, Robert E; Walsh, Catharine M; Lerner, Diana G; Fishman, Douglas S

2017-07-01

The current era of healthcare reform emphasizes the provision of effective, safe, equitable, high-quality, and cost-effective care. Within the realm of gastrointestinal endoscopy in adults, renewed efforts are in place to accurately define and measure quality indicators across the spectrum of endoscopic care. In pediatrics, however, this movement has been less-defined and lacks much of the evidence-base that supports these initiatives in adult care. A need, therefore, exists to help define quality metrics tailored to pediatric practice and provide a toolbox for the development of robust quality improvement (QI) programs within pediatric endoscopy units. Use of uniform standards of quality reporting across centers will ensure that data can be compared and compiled on an international level to help guide QI initiatives and inform patients and their caregivers of the true risks and benefits of endoscopy. This report is intended to provide pediatric gastroenterologists with a framework for the development and implementation of endoscopy QI programs within their own centers, based on available evidence and expert opinion from the members of the NASPGHAN Endoscopy Committee. This clinical report will require expansion as further research pertaining to endoscopic quality in pediatrics is published.

Effect of prehospital ultrasound on clinical outcomes of non-trauma patients

DEFF Research Database (Denmark)

Rudolph, Søren Steemann; Sørensen, Martin Kryspin; Svane, Christian

2014-01-01

BACKGROUND: Advances in technology have made prehospital ultrasound (US) examination available. Whether US in the prehospital setting can lead to improvement in clinical outcomes is yet unclear. OBJECTIVE: The aim of this systematic review was to assess whether prehospital US improves clinical...... studies for additional relevant studies. We then performed a risk of bias analysis and descriptive data analysis. RESULTS: We identified 1707 unique citations and included ten studies with a total of 1068 patients undergoing prehospital US examination. Included publications ranged from case series to non...... studies were of large heterogeneity and all showed a high risk of bias. We were thus unable to assess the effect of prehospital US on clinical outcomes. However, consistent reports suggested that US may improve patient management with respect to diagnosis, treatment, and hospital referral....

Clinical effectiveness and cost-effectiveness of interventions for the treatment of anogenital warts: systematic review and economic evaluation.

Science.gov (United States)

Thurgar, Elizabeth; Barton, Samantha; Karner, Charlotta; Edwards, Steven J

2016-03-01

treatment. Podophyllotoxin 0.5% solution (Condyline(®), Takeda Pharmaceutical Company Ltd; Warticon(®) solution, Stiefel Laboratories Ltd) was found to be the most effective topical treatment evaluated. Networks for other outcomes included fewer treatments, which restrict conclusions on the comparative effectiveness of interventions. In total, 84 treatment strategies were assessed using the economic model. Podophyllotoxin 0.5% solution first line followed by carbon dioxide (CO2) laser therapy second line if AGWs did not clear was most likely to be considered a cost-effective use of resources at a willingness to pay of £20,000-30,000 per additional quality-adjusted life-year gained. The result was robust to most sensitivity analyses conducted. Limited reporting in identified studies of baseline characteristics for the enrolled population generates uncertainty around the comparability of the study populations and therefore the generalisability of the results to clinical practice. Subgroup analyses were planned based on type, number and size of AGWs, all of which are factors thought to influence treatment effect. Lack of data on clinical effectiveness based on these characteristics precluded analysis of the differential effects of treatments in the subgroups of interest. Despite identification of 60 studies, most comparisons in the MTC are informed by only one RCT. Additionally, lack of head-to-head RCTs comparing key treatments, together with minimal reporting of results in some studies, precluded comprehensive analysis of all treatments for AGWs. The results generated by the MTC are in agreement with consensus opinion that ablative techniques are clinically more effective at completely clearing AGWs after treatment. However, the evidence base informing the MTC is limited. A head-to-head RCT that evaluates the comparative effectiveness of interventions used in clinical practice would help to discern the potential advantages and disadvantages of the individual treatments

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

Science.gov (United States)

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

Effectiveness of nurse-led cardiac clinics in adult patients with a diagnosis of coronary heart disease.

Science.gov (United States)

Page, Tamara; Lockwood, Craig; Conroy-Hiller, Tiffany

2005-02-01

Background  Coronary heart disease is the major cause of illness and death in Western countries and this is likely to increase as the average age of the population rises. Consumers with established coronary heart disease are at the highest risk of experiencing further coronary events. Lifestyle measures can contribute significantly to a reduction in cardiovascular mortality in established coronary heart disease. Improved management of cardiac risk factors by providing education and referrals as required has been suggested as one way of maintaining quality care in patients with established coronary heart disease. There is a need to ascertain whether or not nurse-led clinics would be an effective adjunct for patients with coronary heart disease to supplement general practitioner advice and care. Objectives  The objective of this review was to present the best available evidence related to nurse-led cardiac clinics. Inclusion criteria  This review considered any randomised controlled trials that evaluated cardiac nurse-led clinics. In the absence of randomised controlled trials, other research designs such as non-randomised controlled trials and before and after studies were considered for inclusion. Participants were adults (18 years and older) with new or existing coronary heart disease. The interventions of interest to the review included education, assessment, consultation, referral and administrative structures. Outcomes measured included adverse event rates, readmissions, admissions, clinical and cost effectiveness, consumer satisfaction and compliance with therapy. Results  Based on the search terms used, 80 papers were initially identified and reviewed for inclusion; full reports of 24 of these papers were retrieved. There were no papers included that addressed cost effectiveness or adverse events; and none addressed the outcome of referrals. A critical appraisal of the 24 remaining papers identified a total of six randomised controlled trials that

Basics of case report form designing in clinical research.

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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.

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.

No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals.

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Gabler, Nicole B; Duan, Naihua; Raneses, Eli; Suttner, Leah; Ciarametaro, Michael; Cooney, Elizabeth; Dubois, Robert W; Halpern, Scott D; Kravitz, Richard L

2016-07-16

When subgroup analyses are not correctly analyzed and reported, incorrect conclusions may be drawn, and inappropriate treatments provided. Despite the increased recognition of the importance of subgroup analysis, little information exists regarding the prevalence, appropriateness, and study characteristics that influence subgroup analysis. The objective of this study is to determine (1) if the use of subgroup analyses and multivariable risk indices has increased, (2) whether statistical methodology has improved over time, and (3) which study characteristics predict subgroup analysis. We randomly selected randomized controlled trials (RCTs) from five high-impact general medical journals during three time periods. Data from these articles were abstracted in duplicate using standard forms and a standard protocol. Subgroup analysis was defined as reporting any subgroup effect. Appropriate methods for subgroup analysis included a formal test for heterogeneity or interaction across treatment-by-covariate groups. We used logistic regression to determine the variables significantly associated with any subgroup analysis or, among RCTs reporting subgroup analyses, using appropriate methodology. The final sample of 416 articles reported 437 RCTs, of which 270 (62 %) reported subgroup analysis. Among these, 185 (69 %) used appropriate methods to conduct such analyses. Subgroup analysis was reported in 62, 55, and 67 % of the articles from 2007, 2010, and 2013, respectively. The percentage using appropriate methods decreased over the three time points from 77 % in 2007 to 63 % in 2013 (p < 0.05). Significant predictors of reporting subgroup analysis included industry funding (OR 1.94 (95 % CI 1.17, 3.21)), sample size (OR 1.98 per quintile (1.64, 2.40), and a significant primary outcome (OR 0.55 (0.33, 0.92)). The use of appropriate methods to conduct subgroup analysis decreased by year (OR 0.88 (0.76, 1.00)) and was less common with industry funding (OR 0.35 (0.18, 0

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

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

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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

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

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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

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

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Kunimitsu Ayano

2009-04-01

Full Text Available Abstract Background The accuracy of malaria case reporting is challenging due to restricted human and material resources in many countries. The reporting often depends on the clinical diagnosis because of the scarcity of microscopic examinations. Particularly, clinical malaria case reporting by primary health care facilities (local clinics, which constitutes the baseline data of surveillance, has never previously been sufficiently evaluated. In order to improve the malaria reporting system to the level required to eventually eliminate this disease, this study estimates the gaps between the records of clinics and government statistics regarding the incidence of clinical malaria, and then also examines some factors that might explain the data discrepancy, including such variables as clinic staffing and record keeping. Methods All medical records for outpatients in 2007, handwritten by nurses, were collected from local clinics in Honiara, the capital of the Solomon Islands. The all-monthly clinical malaria cases were then recalculated. The corresponding monthly data in official statistics were provided by the government. Next, in order to estimate any data discrepancy, the ratio of the cases recorded at clinics to the cases reported to the government was determined on the monthly basis. Finally, the associations between the monthly discrepancy and other variables were evaluated by a multiple regression analysis. Results The mean data discrepancy between the records of clinics and government statistics was 21.2% (n = 96. Significant associations were observed between the discrepancy and the average number of patients (coefficient: 0.05, 95%CI: 0.31, 0.07, illegible handwriting (coefficient: 0.09, 95%CI: 0.04, 0.15, the use of tally sheets (coefficient:-0.38, 95%CI: -0.54, -0.22, and the clinic level (coefficient:-0.48, 95%CI:-0.89,-0.06. Conclusion The findings of this study demonstrate the huge data discrepancy between the records of clinics and

Bystander effects and their implications for clinical radiotherapy

International Nuclear Information System (INIS)

Munro, Alastair J

2009-01-01

Radiation-induced bystander effects are defined as those biological effects expressed, after irradiation, by cells whose nuclei have not been directly irradiated. Radiation oncologists are only gradually beginning to appreciate the clinical relevance of radiation-induced bystander effects and associated phenomena: adaptive responses, genomic instability and abscopal effects. Incorporating bystander effects into the science underpinning clinical radiotherapy will involve moving beyond simple mechanistic models and towards a more systems-based approach. It is, given the protean nature of bystander effects, difficult to devise a coherent research strategy to investigate the clinical impact and relevance of bystander phenomena. Epidemiological approaches will be required, the traditional research models based on randomised controlled trials are unlikely to be adequate for the task. Any consideration of bystander effects challenges not only clinicians' preconceptions concerning the effects of radiation on tumours and normal tissues but also their ingenuity. This review covers, from a clinical perspective, the issues and problems associated with radiation-induced bystander effects.

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

What are the effective ways to translate clinical leadership into health care quality improvement?

Science.gov (United States)

McSherry, Robert; Pearce, Paddy

2016-01-01

The presence and/or absence of effective leaders in health care can have a stark consequence on the quality and outcomes of care. The delivery of safe, quality, compassionate health care is dependent on having effective clinical leaders at the frontline. In light of the Kirkup and Francis reports, this article explores some ways of translating clinical leadership into health care quality improvement. This is achieved by exploring what is clinical leadership and why and how this is important to health care quality improvement, clinical leadership, and a duty of candor, along with the importance clinical leadership plays in the provision of quality care improvement and outcomes. Clinical leaders are not predefined roles but emerge from the complex clinical setting by gaining an acquired expertise and from how they then internalize this to develop and facilitate sound relationships within a team. Clinical leaders are effective in facilitating innovation and change through improvement. This is achieved by recognizing, influencing, and empowering individuals through effective communication in order to share and learn from and with each other in practice. The challenge for health care organizations in regard to creating organizational cultures where a duty of candor exists is not to reinvent the wheel by turning something that is simple into something complex, which can become confusing to health care workers, patients, and the public. By focusing on the clinical leader's role and responsibilities we would argue they play a crucial and pivotal role in influencing, facilitating, supporting, and monitoring that this duty of candor happens in practice. This may be possible by highlighting where and how the duty of candor can be aligned within existing clinical governance frameworks.

The Effect of Curanderismo on Chronic Non-malignant Pain: A Case Report.

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Kennedy, Laura; Gonzales, Erin; Corbin, Lisa

2016-01-01

This case study describes the effects of the use of curanderismo, an indigenous healing modality combining techniques in massage, sound, and aromatherapy, on a patient with chronic pain. Despite being a commonly used health practice in certain populations, little is reported in the medical literature about the use of curanderismo. Case report as part of a larger randomized trial of curanderismo for chronic pain. Setting was a community-based hospital affiliated primary care clinic. An adult patient with chronic, opioid dependent back pain following an injury, and subsequent spinal fusion was treated. Intervention was the patient received 33 curanderismo treatment sessions over 10 months in addition to ongoing conventional treatment at a community-based chronic pain management clinic. Main outcomes measures were self-reported assessments of pain, functional ability, mood, insomnia, and narcotic usage. Secondary outcome measure was qualitative interview. Although there was no change in quantitative self-reported pain measures, the patient reported improved function, mood, and sleep as well as decreased narcotic usage. Curanderismo, in addition to conventional pain management, improved patient reported symptoms and functional ability, led to healthy lifestyle changes, and decreased narcotic usage. Controlled studies are needed to confirm the benefit of curanderismo as safe, non-interventional, and cost-effective adjunct for chronic pain management. Copyright © 2016 Elsevier Inc. All rights reserved.

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

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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

[Clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis].

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Oyake, Daisuke; Ochi, Kentaro; Takatsu, Mitsuharu; Shintani, Toshiharu; Umehara, Tsuyoshi; Koizuka, Izumi

2004-07-01

The clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis was evaluated. A bipolar radiofrequency system (CelonLab ENT) was used to treat 16 patients suffering from allergic rhinitis between February 2003 and August 2003. The thermotherapy was performed under local anesthesia at the otolaryngology outpatient clinic of St. Marianna University Toyoko Hospital. Data were collected by questionnaire and rhinomanometry preoperatively and 2 months postoperatively. The mean visual analogue scale (VAS) score for intraoperative pain was 31 mm (range, 0-100), and nearly all the patients felt no or a subtle pain during the thermotherapy. Postoperative pain was also well tolerated, with nearly all the patients not requiring analgesic drugs. Postoperative bleeding was minor, and none of the patients required additional treatment for bleeding. Nearly all the patients reported an improvement in their nasal patency, rhinorrhea, headaches, and sleeping. Statistically significant improvements were observed for all the measured VAS scores: nasal patency, rhinorrhea, headache, and olfactory function. Nasal resistance, as measured by anterior rhinomanometry, significantly improved after treatment. The effect of decongestion was also measured using anterior rhinomanometry. The ratio of nasal resistance before and after decongestion was significantly higher after thermotherapy, suggesting that nasal decongestion had a smaller effect on nasal patency after treatment. The current results suggest that the CelonLab ENT device is an effective and safe treatment for allergic rhinitis.

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

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.

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.

Environment-effect reporting. Chapter 6

International Nuclear Information System (INIS)

Hermens, P.A.H.

1989-01-01

Environment-effect reporting is a tool in the resolution of one or more government bodies about activities which may have important disadvantageous impacts upon the environment. This chapter gives a treatment of environment-effect reporting as a process consisting of the preparation, draw-up, judgement and use of an environment-effect report (MER), followed by an evaluation. The contentsof an environment-effect report are indicated. The role of environment-effect reporting in relation with other procedures is discussed. Some experience with the application of environment-effect reporting is presented and a number of experiences in the application are discussed. (H.W.). 5 refs.; 3 figs.; 3 tabs

What are the effective ways to translate clinical leadership into health care quality improvement?

Directory of Open Access Journals (Sweden)

McSherry R

2016-02-01

Full Text Available Robert McSherry,1 Paddy Pearce2 1School of Health and Social Care, University of Teesside, Middlesbrough, 2PKP Consulting, Yarm, United Kingdom Abstract: The presence and/or absence of effective leaders in health care can have a stark consequence on the quality and outcomes of care. The delivery of safe, quality, compassionate health care is dependent on having effective clinical leaders at the frontline. In light of the Kirkup and Francis reports, this article explores some ways of translating clinical leadership into health care quality improvement. This is achieved by exploring what is clinical leadership and why and how this is important to health care quality improvement, clinical leadership, and a duty of candor, along with the importance clinical leadership plays in the provision of quality care improvement and outcomes. Clinical leaders are not predefined roles but emerge from the complex clinical setting by gaining an acquired expertise and from how they then internalize this to develop and facilitate sound relationships within a team. Clinical leaders are effective in facilitating innovation and change through improvement. This is achieved by recognizing, influencing, and empowering individuals through effective communication in order to share and learn from and with each other in practice. The challenge for health care organizations in regard to creating organizational cultures where a duty of candor exists is not to reinvent the wheel by turning something that is simple into something complex, which can become confusing to health care workers, patients, and the public. By focusing on the clinical leader's role and responsibilities we would argue they play a crucial and pivotal role in influencing, facilitating, supporting, and monitoring that this duty of candor happens in practice. This may be possible by highlighting where and how the duty of candor can be aligned within existing clinical governance frameworks. Keywords: governance

Clinical Prediction Models for Cardiovascular Disease: Tufts Predictive Analytics and Comparative Effectiveness Clinical Prediction Model Database.

Science.gov (United States)

Wessler, Benjamin S; Lai Yh, Lana; Kramer, Whitney; Cangelosi, Michael; Raman, Gowri; Lutz, Jennifer S; Kent, David M

2015-07-01

Clinical prediction models (CPMs) estimate the probability of clinical outcomes and hold the potential to improve decision making and individualize care. For patients with cardiovascular disease, there are numerous CPMs available although the extent of this literature is not well described. We conducted a systematic review for articles containing CPMs for cardiovascular disease published between January 1990 and May 2012. Cardiovascular disease includes coronary heart disease, heart failure, arrhythmias, stroke, venous thromboembolism, and peripheral vascular disease. We created a novel database and characterized CPMs based on the stage of development, population under study, performance, covariates, and predicted outcomes. There are 796 models included in this database. The number of CPMs published each year is increasing steadily over time. Seven hundred seventeen (90%) are de novo CPMs, 21 (3%) are CPM recalibrations, and 58 (7%) are CPM adaptations. This database contains CPMs for 31 index conditions, including 215 CPMs for patients with coronary artery disease, 168 CPMs for population samples, and 79 models for patients with heart failure. There are 77 distinct index/outcome pairings. Of the de novo models in this database, 450 (63%) report a c-statistic and 259 (36%) report some information on calibration. There is an abundance of CPMs available for a wide assortment of cardiovascular disease conditions, with substantial redundancy in the literature. The comparative performance of these models, the consistency of effects and risk estimates across models and the actual and potential clinical impact of this body of literature is poorly understood. © 2015 American Heart Association, Inc.

Systematic review: treatment pattern and clinical effectiveness and safety of pharmaceutical therapies for Crohn’s disease in Europe

Directory of Open Access Journals (Sweden)

Lelli F

2016-10-01

Full Text Available Filippo Lelli,1 Solomon Nuhoho,2 Xin Ying Lee,3 Weiwei Xu4 1EMEA Hemar, Janssen, Milan, Italy; 2Health Economics, Market Access and Reimbursement, Johnson & Johnson Middle East FZ LLC, Dubai, United Arab Emirates; 3EMEA Hemar, Janssen, Birkerød, Denmark; 4Pharmerit International, Rotterdam, the Netherlands Background: Although many clinical trials have been conducted in treatments of Crohn’s ­disease (CD, whether the trial results were representative of daily practice needs to be supported by studies conducted in real-world settings. Aim: This study aims to identify how CD is treated and what are the clinical effectiveness and safety of the pharmaceutical therapies of CD in real-world settings. Methods: A systematic literature review was conducted based on Medline®, Embase®, and Cochrane. All publications were assessed for title/abstract and full-text according to a predefined study protocol. Data were extracted and reported.Results: A total of 1,998 publications were identified. Fifty studies including six publications reporting treatment pattern and 44 studies reporting clinical effectiveness and safety of pharmaceutical therapies in CD management in Europe were included. 5-Aminosalicylic acid and corticosteroids were reported to be used among 14%–74% of CD patients. Immunomodulators were used by 14%–25% and 29%–31% of CD patients as an initial and follow-up treatment, respectively. Biological therapies were used by 25%–33% of CD patients. A trend toward an increasing use of immunomodulators and biological therapies in Europe has been reported in recent years. Approximately 50% of patients achieved remission on immunomodulator or biologic treatment, although a relapse rate of up to 23% has been reported.Conclusion: There is a trend of treatment shift to immunomodulators and biologics in CD management. Clinical effectiveness of immunomodulators and biologics has been demonstrated, though with a lack of sustainability of the

Effectiveness of nurse-led clinics on service delivery and clinical outcomes in adults with chronic ear, nose and throat complaints: a systematic review.

Science.gov (United States)

Whiteford, Caroline; White, Sarahlouise; Stephenson, Matthew

2016-04-01

waiting times were shorter in nurse led clinics. The other service delivery outcomes were not addressed. Clinical and health outcomes findings were that lower pain/discomfort levels were demonstrated in nurse led clinics but other clinical/health outcomes were not addressed. Financial outcomes findings were that nurse-led clinics were cost effective when compared with medical-led clinics. While all studies reported evidence of the effectiveness of nurse-led clinics in service delivery and clinical outcomes in adults with chronic ear, nose and throat complaints, most of the data was self-reported and many of the outcomes of interest were not considered. The lack of experimental trials means that the level of evidence is low and further research is needed. There was also not enough detail in the financial outcomes from which clear conclusions of the cost benefit of nurse-led clinics could be drawn. Evidence from included studies indicated higher levels of patient satisfaction, cost benefits and lower levels of pain/discomfort in nurse-led clinics, which suggests that nurse-led ear, nose and throat clinics may be considered in the management of adult patients with ear, nose and throat complaints. Currently there is little evidence examining the effectiveness of nurse-led ear, nose and throat clinics. Areas to be addressed by future research should include: levels of patient education, booking queues, levels of self-treatment change in presentation to clinic episodes, reinfection rates, prevention and cure and representation of patients at clinics for same complaint.

Basics of case report form designing in clinical research

Directory of Open Access Journals (Sweden)

Shantala Bellary

2014-01-01

Full Text Available 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.

A descriptive study of effect-size reporting in research reviews.

Science.gov (United States)

Floyd, Judith A

2017-06-01

To describe effect-size reporting in research reviews completed in support of evidence-based practice in nursing. Many research reviews report nurses' critical appraisal of level, quality and overall strength of evidence available to address clinical questions. Several studies of research-review quality suggest effect-size information would be useful to include in these reviews, but none focused on reviewers' attention to effect sizes. Descriptive. One hundred and four reviews indexed in CINAHL as systematic reviews and published from July 2012-February 2014 were examined. Papers were required to be peer-reviewed, written in English, contain an abstract and have at least one nurse author. Reviews were excluded if they did not use critical appraisal methods to address evidence of correlation, prediction or effectiveness. Data from remaining papers (N = 73) were extracted by three or more independent coders using a structured coding form and detailed codebook. Data were stored, viewed and analysed using Microsoft Office Excel ® spreadsheet functions. Sixteen percent (n = 12) of the sample contained effect-size information. Of the 12, six included all the effect-size information recommended by APA guidelines. Independent of completeness of reporting, seven contained discussion of effect sizes in the paper, but none included effect-size information in abstracts. Research reviews available to practicing nurses often fail to include information needed to accurately assess how much improvement may result from implementation of evidence-based policies, programs, protocols or practices. Manuscript reviewers are urged to hold authors to APA standards for reporting/discussing effect-size information in both primary research reports and research reviews. © 2016 John Wiley & Sons Ltd.

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

Science.gov (United States)

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.

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

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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

Mobile physician reporting of clinically significant events-a novel way to improve handoff communication and supervision of resident on call activities.

Science.gov (United States)

Nabors, Christopher; Peterson, Stephen J; Aronow, Wilbert S; Sule, Sachin; Mumtaz, Arif; Shah, Tushar; Eskridge, Etta; Wold, Eric; Stallings, Gary W; Burak, Kathleen Kelly; Goldberg, Randy; Guo, Gary; Sekhri, Arunabh; Mathew, George; Khera, Sahil; Montoya, Jessica; Sharma, Mala; Paudel, Rajiv; Frishman, William H

2014-12-01

Reporting of clinically significant events represents an important mechanism by which patient safety problems may be identified and corrected. However, time pressure and cumbersome report entry procedures have discouraged the full participation of physicians. To improve the process, our internal medicine training program developed an easy-to-use mobile platform that combines the reporting process with patient sign-out. Between August 25, 2011, and January 25, 2012, our trainees entered clinically significant events into i-touch/i-phone/i-pad based devices functioning in wireless-synchrony with our desktop application. Events were collected into daily reports that were sent from the handoff system to program leaders and attending physicians to plan for rounds and to correct safety problems. Using the mobile module, residents entered 31 reportable events per month versus the 12 events per month that were reported via desktop during a previous 6-month study period. Advances in information technology now permit clinically significant events that take place during "off hours" to be identified and reported (via handoff) to next providers and to supervisors via collated reports. This information permits hospital leaders to correct safety issues quickly and effectively, while attending physicians are able to use information gleaned from the reports to optimize rounding plans and to provide additional oversight of trainee on call patient management decisions.

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...

On heterogeneity of treatment effects and clinical freedom.

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Sacristán, J A; Avendaño-Solá, C

2015-01-01

Three decades ago, John R Hampton announced the death of clinical freedom. Since then, evidence-based medicine has been the predominant paradigm in clinical research. By applying a population-based approach, the randomised controlled trial has become the cornerstone for demonstrating the overall effect of a treatment and for developing guidelines. The new patient-centred medicine movement is rediscovering the important implications of heterogeneity of treatment effects for clinical practice and that a better understanding of such variability can contribute to improve health outcomes for individual patients through practicing a science-based clinical freedom. © 2015 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

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

Perceptual derailment and confabulation in the Rorschach projective technique: a clinical report

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Giovanni Genovese

2015-12-01

Full Text Available Perceptual derailment and confabulations often appear in a subtle way, being processes addressable to the field of inner world, conditioning the diagnostic process. The present clinical report aims to explore the role of Rorschach projective technique in eliciting processes otherwise unsearchable. Psycho-diagnostics data were compared to other psychometric tests such as the MMPI-2 (Minnesota Multiphasic Personality Inventory and the POMS (Profile of Mood States at time 0 and time 1 (after six months. Among these, the exploration of the projective process was crucial to understand the patient's mental functioning, as an elective instrument,  thanks to its ambiguous nature, which leads to effectively explore both the inner world and the cognitive processes.

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 ...

Effect, Feasibility, and Clinical Relevance of Cell Enrichment in Large Volume Fat Grafting

DEFF Research Database (Denmark)

Rasmussen, Bo Sonnich; Lykke Sørensen, Celine; Vester-Glowinski, Peter Viktor

2017-01-01

Large volume fat grafting is limited by unpredictable volume loss; therefore, methods of improving graft retention have been developed. Fat graft enrichment with either stromal vascular fraction (SVF) cells or adipose tissue-derived stem/stromal cells (ASCs) has been investigated in several animal...... and human studies, and significantly improved graft retention has been reported. Improvement of graft retention and the feasibility of these techniques are equally important in evaluating the clinical relevance of cell enrichment. We conducted a systematic search of PubMed to identify studies on fat graft...... enrichment that used either SVF cells or ASCs, and only studies reporting volume assessment were included. A total of 38 articles (15 human and 23 animal) were included to investigate the effects of cell enrichment on graft retention as well as the feasibility and clinical relevance of cell-enriched fat...

Educational effects using a robot patient simulation system for development of clinical attitude.

Science.gov (United States)

Abe, S; Noguchi, N; Matsuka, Y; Shinohara, C; Kimura, T; Oka, K; Okura, K; Rodis, O M M; Kawano, F

2017-11-01

The aim of this study was to assess the effectiveness of improving the attitude of dental students towards the use of a full-body patient simulation system (SIMROID) compared to the traditional mannequin (CLINSIM) for dental clinical education. The participants were 10 male undergraduate dental students who had finished clinical training in the university hospital 1 year before this study started. They performed a crown preparation on an upper pre-molar tooth using SIMROID and CLINSIM as the practical clinical trials. The elapsed time for preparation was recorded. The taper of the abutment teeth was measured using a 3-dimensional shape-measuring device after this trial. In addition, a self-reported questionnaire was collected that included physical pain, treatment safety and maintaining a clean area for each simulator. Qualitative data analysis of a free format report about SIMROID was performed using text mining analysis. This trial was performed twice at 1-month intervals. The students considered physical pain, treatment safety and a clean area for SIMROID significantly better than that for CLINSIM (P mining analysis, most of the students wrote that SIMROID was similar to real patients. The use of SIMROID was proven to be effective in improving the attitude of students towards patients, thereby giving importance to considerations for actual patients during dental treatment. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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.

Updated clinical guidelines experience major reporting limitations

Directory of Open Access Journals (Sweden)

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

Effect of voice recognition on radiologist reporting time

International Nuclear Information System (INIS)

Bhan, S.N.; Coblentz, C.L.; Norman, G.R.; Ali, S.H.

2008-01-01

To study the effect that voice recognition (VR) has on radiologist reporting efficiency in a clinical setting and to identify variables associated with faster reporting time. Five radiologists were observed during the routine reporting of 402 plain radiograph studies using either VR (n 217) or conventional dictation (CD) (n = 185). Two radiologists were observed reporting 66 computed tomography (CT) studies using either VR (n - 39) or CD (n - 27). The time spent per reporting cycle, defined as the radiologist's time spent on a study from report finalization to the subsequent report finalization, was compared. As well, characteristics about the radiologist and their reporting style were collected and correlated against reporting time. For plain radiographs, radiologists took 134% (P = 0.048) more time to produce reports using VR, but there was significant variability between radiologists. Significant association with faster reporting times using VR included: English as a first language (r-0.24), use of a template (r -0.34), use of a headset microphone (r -0.46), and increased experience with VR (r -0.43). Experience as a staff radiologist and having previous study for comparison did not correlate with reporting time. For CT, there was no significant difference in reporting time identified between VR and CD (P 0.61). Overall, VR slightly decreases the reporting efficiency of radiologists. However, efficiency may be improved if English is a first language, a headset microphone, and macros and templates are use. (author)

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.

Science.gov (United States)

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

Comparing the Quality of Ambulatory Surgical Care for Skin Cancer in a Veterans Affairs Clinic and a Fee-For-Service Practice Using Clinical and Patient-Reported Measures.

Science.gov (United States)

Dizon, Matthew P; Linos, Eleni; Arron, Sarah T; Hills, Nancy K; Chren, Mary-Margaret

2017-01-01

The Institute of Medicine has identified serious deficiencies in the measurement of cancer care quality, including the effects on quality of life and patient experience. Moreover, comparisons of quality in Veterans Affairs Medical Centers (VA) and other sites are timely now that many Veterans can choose where to seek care. To compare quality of ambulatory surgical care for keratinocyte carcinoma (KC) between a VA and fee-for-service (FFS) practice, we used unique clinical and patient-reported data from a comparative effectiveness study. Patients were enrolled in 1999-2000 and followed for a median of 7.2 years. The practices differed in a few process measures (e.g., median time between biopsy and treatment was 7.5 days longer at VA) but there were no substantial or consistent differences in clinical outcomes or a broad range of patient-reported outcomes. For example, 5-year tumor recurrence rates were equally low (3.6% [2.3-5.5] at VA and 3.4% [2.3-5.1] at FFS), and similar proportions of patients reported overall satisfaction at one year (78% at VA and 80% at FFS, P = 0.69). These results suggest that the quality of care for KC can be compared comprehensively in different health care systems, and suggest that quality of care for KC was similar at a VA and FFS setting.

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.

Effect of xylitol versus sorbitol: a quantitative systematic review of clinical trials.

Science.gov (United States)

Mickenautsch, Steffen; Yengopal, Veerasamy

2012-08-01

This study aimed to appraise, within the context of tooth caries, the current clinical evidence and its risk for bias regarding the effects of xylitol in comparison with sorbitol. Databases were searched for clinical trials to 19 March 2011. Inclusion criteria required studies to: test a caries-related primary outcome; compare the effects of xylitol with those of sorbitol; describe a clinical trial with two or more arms, and utilise a prospective study design. Articles were excluded if they did not report computable data or did not follow up test and control groups in the same way. Individual dichotomous and continuous datasets were extracted from accepted articles. Selection and performance/detection bias were assessed. Sensitivity analysis was used to investigate attrition bias. Egger's regression and funnel plotting were used to investigate risk for publication bias. Nine articles were identified. Of these, eight were accepted and one was excluded. Ten continuous and eight dichotomous datasets were extracted. Because of high clinical heterogeneity, no meta-analysis was performed. Most of the datasets favoured xylitol, but this was not consistent. The accepted trials may be limited by selection bias. Results of the sensitivity analysis indicate a high risk for attrition bias. The funnel plot and Egger's regression results suggest a low publication bias risk. External fluoride exposure and stimulated saliva flow may have confounded the measured anticariogenic effect of xylitol. The evidence identified in support of xylitol over sorbitol is contradictory, is at high risk for selection and attrition bias and may be limited by confounder effects. Future high-quality randomised controlled trials are needed to show whether xylitol has a greater anticariogenic effect than sorbitol. © 2012 FDI World Dental Federation.

Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

Directory of Open Access Journals (Sweden)

Melanie Calvert

Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

Permissive or Trophic Enteral Nutrition and Full Enteral Nutrition Had Similar Effects on Clinical Outcomes in Intensive Care: A Systematic Review of Randomized Clinical Trials.

Science.gov (United States)

Silva, Camila F A; de Vasconcelos, Simone G; da Silva, Thales A; Silva, Flávia M

2018-01-26

The aim of this study was to systematically review the effect of permissive underfeeding/trophic feeding on the clinical outcomes of critically ill patients. A systematic review of randomized clinical trials to evaluate the mortality, length of stay, and mechanical ventilation duration in patients randomized to either hypocaloric or full-energy enteral nutrition was performed. Data sources included PubMed and Scopus and the reference lists of the articles retrieved. Two independent reviewers participated in all phases of this systematic review as proposed by the Cochrane Handbook, and the review was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 7 randomized clinical trials that included a total of 1,717 patients were reviewed. Intensive care unit length of stay and mechanical ventilation duration were not statistically different between the intervention and control groups in all randomized clinical trials, and mortality rate was also not different between the groups. In conclusion, hypocaloric enteral nutrition had no significantly different effects on morbidity and mortality in critically ill patients when compared with full-energy nutrition. It is still necessary to determine the safety of this intervention in this group of patients, the optimal amount of energy provided, and the duration of this therapy. © 2018 American Society for Parenteral and Enteral Nutrition.

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

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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.

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

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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.

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

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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.

Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports

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Duric Nezla S

2012-08-01

Full Text Available Abstract Background A randomized and controlled clinical study was performed to evaluate the use of neurofeedback (NF to treat attention-deficit/hyperactivity disorder (ADHD in children and adolescents. Methods The ADHD population was selected from an outpatient clinic for Child and Adolescent Mental Health in Norway. Ninety-one of the 275 children and adolescents ranging in age from 6 to 18 years (10.5 years participated in 30 sessions of an intensive NF program. The reinforcement contingency was based on the subjects’ production of cortical beta1 activity (15–18 Hz. The ADHD participants were randomized into three groups, with 30 in the NF group, 31 controls in a group that was given methylphenidate, and 30 in a group that received NF and methylphenidate. ADHD core symptoms were reported by parents using the parent form of the Clinician’s Manual for Assessment by Russell A. Barkley. Results Ninety-one children and adolescents were effectively randomized by age, sex, intelligence and distribution of ADHD core symptoms. The parents reported significant effects of the treatments, but no significant differences between the treatment groups were observed. Conclusions NF was as effective as methylphenidate at treating the attentional and hyperactivity symptoms of ADHD, based on parental reports. Trial registration Current Controlled Trials NCT01252446

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

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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

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

Effects of basic clinical skills training on objective structured clinical examination performance.

Science.gov (United States)

Jünger, Jana; Schäfer, Sybille; Roth, Christiane; Schellberg, Dieter; Friedman Ben-David, Miriam; Nikendei, Christoph

2005-10-01

The aim of curriculum reform in medical education is to improve students' clinical and communication skills. However, there are contradicting results regarding the effectiveness of such reforms. A study of internal medicine students was carried out using a static group design. The experimental group consisted of 77 students participating in 7 sessions of communication training, 7 sessions of skills-laboratory training and 7 sessions of bedside-teaching, each lasting 1.5 hours. The control group of 66 students from the traditional curriculum participated in equally as many sessions but was offered only bedside teaching. Students' cognitive and practical skills performance was assessed using Multiple Choice Question (MCQ) testing and an objective structured clinical examination (OSCE), delivered by examiners blind to group membership. The experimental group performed significantly better on the OSCE than did the control group (P < 0.01), whereas the groups did not differ on the MCQ test (P < 0.15). This indicates that specific training in communication and basic clinical skills enabled students to perform better in an OSCE, whereas its effects on knowledge did not differ from those of the traditional curriculum. Curriculum reform promoting communication and basic clinical skills are effective and lead to an improved performance in history taking and physical examination skills.

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...

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

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

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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.

Effectiveness of manual therapies: the UK evidence report.

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Bronfort, Gert; Haas, Mitch; Evans, Roni; Leininger, Brent; Triano, Jay

2010-02-25

The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs. By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines.Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments. Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1

Effectiveness of manual therapies: the UK evidence report

Directory of Open Access Journals (Sweden)

Leininger Brent

2010-02-01

Full Text Available Abstract Background The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. Methods The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs, widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs. Results By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines. Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments. Conclusions Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and

Clinical Effectiveness of Prospectively Reported Sonographic Twinkling Artifact for the Diagnosis of Renal Calculus in Patients Without Known Urolithiasis.

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Masch, William R; Cohan, Richard H; Ellis, James H; Dillman, Jonathan R; Rubin, Jonathan M; Davenport, Matthew S

2016-02-01

The purpose of this study was to determine the clinical effectiveness of prospectively reported sonographic twinkling artifact for the diagnosis of renal calculus in patients without known urolithiasis. All ultrasound reports finalized in one health system from June 15, 2011, to June 14, 2014, that contained the words "twinkle" or "twinkling" in reference to suspected renal calculus were identified. Patients with known urolithiasis or lack of a suitable reference standard (unenhanced abdominal CT with ≤ 2.5-mm slice thickness performed ≤ 30 days after ultrasound) were excluded. The sensitivity, specificity, and positive likelihood ratio of sonographic twinkling artifact for the diagnosis of renal calculus were calculated by renal unit and stratified by two additional diagnostic features for calcification (echogenic focus, posterior acoustic shadowing). Eighty-five patients formed the study population. Isolated sonographic twinkling artifact had sensitivity of 0.78 (82/105), specificity of 0.40 (26/65), and a positive likelihood ratio of 1.30 for the diagnosis of renal calculus. Specificity and positive likelihood ratio improved and sensitivity declined when the following additional diagnostic features were present: sonographic twinkling artifact and echogenic focus (sensitivity, 0.61 [64/105]; specificity, 0.65 [42/65]; positive likelihood ratio, 1.72); sonographic twinkling artifact and posterior acoustic shadowing (sensitivity, 0.31 [33/105]; specificity, 0.95 [62/65]; positive likelihood ratio, 6.81); all three features (sensitivity, 0.31 [33/105]; specificity, 0.95 [62/65]; positive likelihood ratio, 6.81). Isolated sonographic twinkling artifact has a high false-positive rate (60%) for the diagnosis of renal calculus in patients without known urolithiasis.

Effectiveness of clinical supervision of physiotherapists: a survey.

Science.gov (United States)

Snowdon, David A; Millard, Geraldine; Taylor, Nicholas F

2015-04-01

Limited literature exists on the practice of clinical supervision (CS) of professional physiotherapists despite current Australian safety and quality health standards stating that CS is to be provided to all physiotherapists. The aim of the present study was to evaluate the effectiveness of CS of physiotherapists working in an Australian public health service. CS was measured using the allied health-specific 26-item modified Manchester Clinical Supervision Scale (MCSS-26). Subscales of the MCSS-26 were summed for three domain scores (normative, restorative and formative) and a total score was calculated, which was compared with the reported threshold score of 73 for effective supervision. Sixty registered physiotherapists (response rate 92%), working for a large metropolitan public health service, with six different site locations, completed the survey. The mean (± s.d.) total MCSS-26 score was 71.0 ± 14.3 (95% confidence interval (CI) 67.4-74.6). Hospital site was the only variable that had a significant effect on total MCSS-26 score (P=0.005); there was no effect for supervisor or supervisee experience, or hospital setting (acute vs subacute). Physiotherapists scored a significantly lower mean percentage MCSS-26 score on the normative domain compared with the restorative domain (mean difference 7.8%; 95% CI 2.9-12.7; P=0.002) and the formative domain (mean difference 9.6%; 95% CI 6.3-13.0; P<0.001). Of the two subscales that form the normative domain, 'finding time' had a significantly lower mean percentage MCSS-26 score than 'importance/value of CS' (mean difference 35.4%; 95% CI 31.3-39.4; P<0.001). Within this publicly funded physiotherapy department there was uncertainty about the effectiveness of CS, with more than half the physiotherapists rating their supervision as less than effective, suggesting there is opportunity for improvement in the practice of physiotherapy CS. Physiotherapists scored lowest in the normative domain, indicating that they found it

Random effects models in clinical research

NARCIS (Netherlands)

Cleophas, T. J.; Zwinderman, A. H.

2008-01-01

BACKGROUND: In clinical trials a fixed effects research model assumes that the patients selected for a specific treatment have the same true quantitative effect and that the differences observed are residual error. If, however, we have reasons to believe that certain patients respond differently

Effects of Ramadan fasting on spirometric values and clinical symptoms in asthmatic patients

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Abdolreza Norouzy

2013-03-01

Full Text Available Introduction: Ramadan is the 9th  Islamic lunar month during which Muslims avoid eating and drinking from sunrise to sunset.  The effect of Ramadan intermittent fasting on asthma control is controversial.  The aim of this study was to investigate the effects of Ramadan fasting on the spirometric variables and clinical symptoms on well-controlled asthmatic patients during Ramadan. Material and Methods: a cohort study was conducted in Mashhad, Khorasan Razavi, Iran. Twenty-nine (19 females and 10 males well-controlled asthmatic patients aged 47 (12 years completed the study.  The average duration of fasting was 26.5 days. Assessment of spirometric variables (daily peak expiratory flow, peak expiratory flow variability, peak expiratory flow home monitoring as well as asthma clinical symptoms including dyspnea, cough, wheezing, and chest tightness were carried out. Results: No significant changes in clinical symptoms were reported in asthmatic patients at the end of Ramadan fasting.  Among spirometric variables, only peak expiratory flow improved after Ramadan (p

The effectiveness of online cognitive behavioral treatment in routine clinical practice.

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Jeroen Ruwaard

Full Text Available Randomized controlled trails have identified online cognitive behavioral therapy as an efficacious intervention in the management of common mental health disorders.To assess the effectiveness of online CBT for different mental disorders in routine clinical practice.An uncontrolled before-after study, with measurements at baseline, posttest, 6-week follow-up, and 1-year follow-up.1500 adult patients (female: 67%; mean age: 40 years with a GP referral for psychotherapy were treated at a Dutch online mental health clinic for symptoms of depression (n = 413, panic disorder (n = 139, posttraumatic stress (n = 478, or burnout (n = 470.Manualized, web-based, therapist-assisted CBT, of which the efficacy was previously demonstrated in a series of controlled trials. Standardized duration of treatment varied from 5 weeks (online CBT for Posttraumatic stress to 16 weeks (online CBT for Depression.Validated self-report questionnaires of specific and general psychopathology, including the Beck Depression Inventory, the Impact of Event Scale, the Panic Disorder Severity Scale-Self Report, the Oldenburg Burnout Inventory, and the Depression Anxiety Stress Scales.Treatment adherence was 71% (n = 1071. Study attrition was 21% at posttest, 33% at 6-week FU and 65% at 1-year FU. Mixed-model repeated measures regression identified large short-term reductions in all measures of primary symptoms (d = 1.9±0.2 to d = 1.2±0.2; P<.001, which sustained up to one year after treatment. At posttest, rates of reliable improvement and recovery were 71% and 52% in the completer sample (full sample: 55%/40%. Patient satisfaction was high.Results suggest that online therapist-assisted CBT may be as effective in routine practice as it is in clinical trials. Although pre-treatment withdrawal and long-term outcomes require further study, results warrant continued implementation of online CBT.

Can Trainees Effectively Deliver Dialectical Behavior Therapy for Individuals With Borderline Personality Disorder? Outcomes From a Training Clinic.

Science.gov (United States)

Rizvi, Shireen L; Hughes, Christopher D; Hittman, Alexandra D; Vieira Oliveira, Pedro

2017-12-01

The aim of the current study was to evaluate the effectiveness of a 6-month course of comprehensive dialectical behavior therapy (DBT) provided in a training clinic with doctoral students as therapists and assessors. Clinical outcomes for 50 individuals with borderline personality disorder (80% female, M age = 29.52 [SD = 9.64]) are reported. Reliable change indices and clinical significance were calculated for measures. Finally, our results were benchmarked against a "gold standard" randomized clinical trial (RCT; McMain et al., 2009). Analyses with both the full sample and the treatment completers indicate significant reductions in mental health symptomatology that were reliable, clinically and statistically significant, and comparable in effect size to the benchmarked RCT. This DBT training clinic produced good outcomes, comparable to that of a large RCT. Results have implications for who can provide DBT treatment, as well as improving access to DBT in community settings where training clinics may be located. © 2017 Wiley Periodicals, Inc.

Effect of electronic report writing on the quality of nursing report recording

Science.gov (United States)

Heidarizadeh, Khadijeh; Rassouli, Maryam; Manoochehri, Houman; Tafreshi, Mansoureh Zagheri; Ghorbanpour, Reza Kashef

2017-01-01

Background and Aim Recording performed nursery actions is one of the main chores of nurses. The findings have shown that recorded reports are not qualitatively valid. Since electronic reports can be regarded as a base to write reports, this study aims at determining the effect of utilizing electronic nursing reports on the quality of the records. Methods This quasi-experimental study was conducted with the aim of applying an electronic system of nursing recording in the heart department of Shahid Rahimi Medical Center, Lorestan University of Medical Science. The samples were nursing reports on the hospitalized patients in the heart department, the basis of complete enumeration (census) during the fall of 2014. The subjects were sixteen employed nurses. To do the study, the software of nursing records was set based on the Clinical Care Classification system (CCC). The research’s tool was the checklist of the Standards of Nursing Documentation. Results The findings indicated that before and after the intervention, the amount of reports’ adaption with the written standards, respectively, was (21.8%) and (71.3%), and the most complete recording was medicine status (58%) and (100%). The worst complete recording before the intervention, acute changes was (99.1%) and nursing processes was (78%) and after, the medicine status, intake and output status and patient’s education (100%); while the nursing report structure was regarded in all cases (100%). The results showed that there is a significant difference in the quality of reporting before and after using CCC (pnurses are reminded to record the necessary parts and from the other point, the system does not allow the user to shut it down unless the necessary parameters are recorded. For this reason, the quality of recorded reports with electronic reporting improves. PMID:29238481

The effects of implementing synoptic pathology reporting in cancer diagnosis: a systematic review.

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Sluijter, Caro E; van Lonkhuijzen, Luc R C W; van Slooten, Henk-Jan; Nagtegaal, Iris D; Overbeek, Lucy I H

2016-06-01

Pathology reporting is evolving from a traditional narrative report to a more structured synoptic report. Narrative reporting can cause misinterpretation due to lack of information and structure. In this systematic review, we evaluate the impact of synoptic reporting on completeness of pathology reports and quality of pathology evaluation for solid tumours. Pubmed, Embase and Cochrane databases were systematically searched to identify studies describing the effect of synoptic reporting implementation on completeness of reporting and quality of pathology evaluation of solid malignant tumours. Thirty-three studies met the inclusion criteria. All studies, except one, reported an increased overall completeness of pathology reports after introduction of synoptic reporting (SR). Most frequently studied cancers were breast (n = 9) and colorectal cancer (n = 16). For breast cancer, narrative reports adequately described 'tumour type' and 'nodal status'. Synoptic reporting resulted in improved description of 'resection margins', 'DCIS size', 'location' and 'presence of calcifications'. For colorectal cancer, narrative reports adequately reported 'tumour type', 'invasion depth', 'lymph node counts' and 'nodal status'. Synoptic reporting resulted in increased reporting of 'circumferential margin', 'resection margin', 'perineural invasion' and 'lymphovascular invasion'. In addition, increased numbers of reported lymph nodes were found in synoptic reports. Narrative reports of other cancer types described the traditional parameters adequately, whereas for 'resection margins' and '(lympho)vascular/perineural invasion', implementation of synoptic reporting was necessary. Synoptic reporting results in improved reporting of clinical relevant data. Demonstration of clinical impact of this improved method of pathology reporting is required for successful introduction and implementation in daily pathology practice.

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.

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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.

[Development of Autogenic Training Clinical Effectiveness Scale (ATCES)].

Science.gov (United States)

Ikezuki, Makoto; Miyauchi, Yuko; Yamaguchi, Hajime; Koshikawa, Fusako

2002-02-01

The purpose of the present study was to develop a scale measuring clinical effectiveness of autogenic training. In Study 1, 167 undergraduates completed a survey of items concerning physical and mental states, which were thought to vary in the course of autogenic training. With item and factor analyses, 20 items were selected, and the resulting scale (ATCES) had high discrimination and clear factor structure. In Study 2, reliability and concurrent and clinical validity of the scale were examined with three groups of respondents: 85 mentally healthy, 31 control, 13 clinical persons. The scale showed a high test-retest correlation (r = .83) and alpha coefficient (alpha = .86). ATCES had a Pearson correlation coefficient of r = .56 with General Health Questionnaire (GHQ-12), and r = .73 with trait anxiety (STAI-T). And ATCES successfully discriminated the mentally healthy and clinical groups in terms of clinical effectiveness. These results demonstrated high reliability and sufficient concurrent and clinical validity of the new scale.

Possible Oxcarbazepine Inductive Effects on Aripiprazole Metabolism: A Case Report.

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McGrane, Ian R; Loveland, Joshua G; de Leon, Jose

2017-01-01

Oxcarbazepine is a cytochrome P450 (CYP) 3A4 inducer, which is structurally similar to carbamazepine. Although lacking Food and Drug Administration approval, oxcarbazepine is sometimes prescribed to treat aggressive behavior in youth with autism spectrum disorder (ASD). These youths may also be taking second-generation antipsychotics, some of which are substrates of the CYP3A4 metabolic pathway. The combination of these medications may result in decreased serum antipsychotic concentrations, potentially reducing effectiveness. A limited number of reports are available which discuss reduced atypical antipsychotic concentrations secondary to oxcarbazepine CYP3A4 induction. We report a young boy taking oxcarbazepine (1200 mg/d) who presented with an unexpectedly low serum aripiprazole concentration. Utilizing therapeutic drug monitoring, pharmacogenetic testing, and a tool to evaluate drug-drug interactions, we estimate that oxcarbazepine possibly reduced his serum aripiprazole concentration by 68%. Our report is important, as it is the first to describe a drug-drug interaction between oxcarbazepine and aripiprazole. This report should encourage the completion of in vitro and clinical studies and the publication of case reports describing the possible inductive effects of oxcarbazepine on atypical antipsychotics (including cariprazine, lurasidone, quetiapine, aripiprazole, brexpiprazole, iloperidone, and risperidone) mediated by induction of the CYP3A4 metabolic pathway.

Treatment of malignant gastric outlet obstruction with stents: An evaluation of the reported variables for clinical outcome

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Medhus Asle W

2009-06-01

Full Text Available Abstract Background Malignant gastric outlet obstruction (GOO is commonly seen in patients with advanced gastric-, pancreatic-, duodenal, hepatobiliary or metastatic malignancies. Ten to 25% of patients with pancreatic cancer will develop duodenal obstruction during the course of the disease. Duodenal stenting with self-expandable metal stents is an alternative treatment to surgical bypass procedures. Our aim was to review the published literature regarding treatment of malignant GOO with stents to reveal whether the information provided is sufficient to evaluate the clinical effects of this treatment Methods A literature search from 2000 – 2007 was conducted in Pub Med, Embase, and Cochrane library, combining the following search terms: duodenal stent, malignant duodenal obstruction, gastric outlet obstruction, SEMS, and gastroenteroanastomosis. All publications presenting data with ≥ 15 patients and only articles written in English were included and a review focusing on the following parameters were conducted: 1 The use of graded scoring systems evaluating clinical success; 2 Assessment of Quality of life (QoL before and after treatment; 3 Information on stent-patency; 4 The use of objective criteria to evaluate the stent effect. Results 41 original papers in English were found; no RCT's. 16 out of 41 studies used some sort of graded scoring system. No studies had objectively evaluated QoL before or after stent treatment, using standardized QoL-questionnaires, 32/41 studies reported on stent patency and 9/41 performed an oral contrast examination after stent placement. Objective quantitative tests of gastric emptying had not been performed. Conclusion Available reports do not provide sufficient relevant information of the clinical outcome of duodenal stenting. In future studies, these relevant issues should be addressed to allow improved evaluation of the effect of stent treatment.

Malignant PEComa: a case report with emphasis on clinical and morphological criteria

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Legnini Margherita

2011-01-01

Full Text Available Abstract Background Malignant perivascular epitheliod cell tumor (PEComa is a very rare entity composed of distinctive perivascular epitheliod cells with variable immunoreactivity for melanocytic and muscle markers. At present this neoplasm does not have a known normal cellular counterpart and the natural history is often unpredictable. Up to now, few cases of PEComa have been described and treatment modalities are still controversial, particularly in advanced conditions. Case presentation We handled the case of a 42-year-old man with unresectable PEComa of the abdomen. A 7 cm hepatic hypodense lesion between segment V and VIII of the liver and diffuse intraperitoneal nodules of 0,3-3,5 cm along the right subcapsular hepatic region, were documented by a CT scan. Radiological images showed abnormal lymph nodes of the right internal mammary chain and anterior mediastinum. The patient underwent an explorative laparotomy for uncontrolled intrabdominal hemorrhage without a well-defined preoperative tumor diagnosis. At surgery, multiple lobulated nodules containing hemorrhagic fluid on the liver surface, peritoneum and omentum were confirmed. The procedure had a palliative intent and consisted of hemostasis, hematomas evacuation and omentectomy. The diagnosis of PEComa was made after surgery on the basis of morphological and immunohystochemical criteria. Radiological and intra operative findings suggest that the mass has an hepatic origin with diffuse involvement of hepatic capsule and suspensory ligaments. The patient received medical support care with blood and plasma transfusions. In our experience, PEComa was clinically malignant, leading to a fatal outcome 25 days after hospital admission of patient. Conclusions Here we report and discuss the peculiar clinical, radiological and morphological presentation of unresectable PEComa. Although in the majority of the reported series, PEComas show a more better prognosis, our case presents with a

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

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.

A controlled evaluation of case clinical effect coding by poison center specialists for detection of WMD scenarios.

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Beuhler, Michael C; Wittler, Mary A; Ford, Marsha; Dulaney, Anna R

2011-08-01

Many public health entities employ computer-based syndromic surveillance to monitor for aberrations including possible exposures to weapons of mass destruction (WMD). Often, this is done by screening signs and symptoms reported for cases against syndromic definitions. Poison centers (PCs) may offer significant contributions to public health surveillance because of their detailed clinical effect data field coding and real-time data entry. Because improper clinical effect coding may impede syndromic surveillance, it is important to assess this accuracy for PCs. An AAPCC-certified regional PC assessed the accuracy of clinical effect coding by specialists in poison information (SPIs) listening to audio recordings of standard cases. Eighteen different standardized cases were used, consisting of six cyanide, six botulism, and six control cases. Cases were scripted to simulate clinically relevant telephone conversations and converted to audio recordings. Ten SPIs were randomly selected from the center's staff to listen to and code case information from the recorded cases. Kappa scores and the percentage of correctly coding a present clinical effect were calculated for individual clinical effects summed over all test cases along with corresponding 95% confidence intervals. The rate of the case coding by the SPIs triggering the PC's automated botulism and cyanide alerts was also determined. The kappa scores and the percentage of correctly coding a present clinical effect varied depending on the specific clinical effect, with greater accuracy observed for the clinical effects of vomiting and agitation/irritability, and poor accuracy observed for the clinical effects of visual defect and anion gap increase. Lack of correct coding resulted in only 60 and 86% of the cases that met the botulism and cyanide surveillance definitions, respectively, triggering the corresponding alert. There was no difference observed in the percentage of coding a present clinical effect between

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.

Providing effective supervision in clinical neuropsychology.

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Stucky, Kirk J; Bush, Shane; Donders, Jacobus

2010-01-01

A specialty like clinical neuropsychology is shaped by its selection of trainees, educational standards, expected competencies, and the structure of its training programs. The development of individual competency in this specialty is dependent to a considerable degree on the provision of competent supervision to its trainees. In clinical neuropsychology, as in other areas of professional health-service psychology, supervision is the most frequently used method for teaching a variety of skills, including assessment, report writing, differential diagnosis, and treatment. Although much has been written about the provision of quality supervision in clinical and counseling psychology, very little published guidance is available regarding the teaching and provision of supervision in clinical neuropsychology. The primary focus of this article is to provide a framework and guidance for the development of suggested competency standards for training of neuropsychological supervisors, particularly at the residency level. In this paper we outline important components of supervision for neuropsychology trainees and suggest ways in which clinicians can prepare for supervisory roles. Similar to Falender and Shafranske (2004), we propose a competency-based approach to supervision that advocates for a science-informed, formalized, and objective process that clearly delineates the competencies required for good supervisory practice. As much as possible, supervisory competencies are related to foundational and functional competencies in professional psychology, as well as recent legislative initiatives mandating training in supervision. It is our hope that this article will foster further discussion regarding this complex topic, and eventually enhance training in clinical neuropsychology.

Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

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Jones PW

2016-12-01

Full Text Available Paul W Jones,1,2 Stephen Rennard,3,4 Maggie Tabberer,5 John H Riley,2 Mitra Vahdati-Bolouri,2 Neil C Barnes2,6 1Institute for Infection and Immunity, University of London, London, 2Global Respiratory Franchise, GlaxoSmithKline, Uxbridge, UK; 3Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha, NE, USA; 4Clinical Discovery Unit, AstraZeneca, Cambridge, 5Global R&D, GlaxoSmithKline, Uxbridge, 6William Harvey Institute, Bart’s and the London School of Medicine and Dentistry, London, UK Abstract: One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of

Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

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Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

2014-01-01

The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.

Effects of dry period length on clinical mastitis and other major clinical health disorders

DEFF Research Database (Denmark)

Enevoldsen, Carsten; Sørensen, J.T.

1992-01-01

Four, 7-, and 10-wk dry periods were randomly assigned to 366 dairy cows in eight herds. A multiple polytomous logistic regression analysis was conducted with the objective to reveal possible important effects of the dry period on the risk of contracting major clinical health disorders. Several...... complex statistical interactions were revealed. Complications around and after drying off occurred least frequently at 7-wk dry periods. There was little evidence of an effect of the dry period on the risk of clinical mastitis and other severe clinical disorders around and after calving. With short...... like milk yield at drying off and previous mastitis are much more important predisposing factors....

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…

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

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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.

Systematic review of the clinical effect of glucocorticoids on nonhematologic malignancy

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Keith Bruce D

2008-03-01

Full Text Available Abstract Background Glucocorticoids are often used in the treatment of nonhematologic malignancy. This review summarizes the clinical evidence of the effect of glucocorticoid therapy on nonhematologic malignancy. Methods A systematic review of clinical studies of glucocorticoid therapy in patients with nonhematologic malignancy was undertaken. Only studies having endpoints of tumor response or tumor control or survival were included. PubMed, EMBASE, the Cochrane Register/Databases, conference proceedings (ASCO, AACR, ASTRO/ASTR, ESMO, ECCO and other resources were used. Data was extracted using a standard form. There was quality assessment of each study. There was a narrative synthesis of information, with presentation of results in tables. Where appropriate, meta-analyses were performed using data from published reports and a fixed effect model. Results Fifty four randomized controlled trials (RCTs, one meta-analysis, four phase l/ll trials and four case series met the eligibility criteria. Clinical trials of glucocorticoid monotherapy in breast and prostate cancer showed modest response rates. In advanced breast cancer meta-analyses, the addition of glucocorticoids to either chemotherapy or other endocrine therapy resulted in increased response rate, but not increased survival. In GI cancer, there was one RCT each of glucocorticoids vs. supportive care and chemotherapy +/- glucocorticoids; glucocorticoid effect was neutral. The only RCT found of chemotherapy +/- glucocorticoids, in which the glucocorticoid arm did worse, was in lung cancer. In glucocorticoid monotherapy, meta-analysis found that continuous high dose glucocorticoids had a detrimental effect on survival. The only other evidence, for a detrimental effect of glucocorticoid monotherapy, was in one of the two trials in lung cancer. Conclusion Glucocorticoid monotherapy has some benefit in breast and prostate cancer. In advanced breast cancer, the addition of glucocorticoids to other

Application of failure mode and effects analysis in a clinical chemistry laboratory.

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Jiang, Yuanyuan; Jiang, Hongmin; Ding, Siyi; Liu, Qin

2015-08-25

Timely delivery of correct results has long been considered as the goal of quality management in clinical laboratory. With increasing workload as well as complexities of laboratory testing and patient care, the traditional technical adopted like internal quality control (IQC) and external quality assessment (EQA) may not enough to cope with quality management problems for clinical laboratories. We applied failure mode and effects analysis (FMEA), a proactive tool, to reduce errors associated with the process beginning with sample collection and ending with a test report in a clinical chemistry laboratory. Our main objection was to investigate the feasibility of FMEA in a real-world situation, namely the working environment of hospital. A team of 8 people (3 laboratory workers, 2 couriers, 2 nurses, and 1 physician) from different departments who were involved in the testing process were recruited and trained. Their main responsibility was to analyze and score all possible clinical chemistry laboratory failures based on three aspects: the severity of the outcome (S), the likeliness of occurrence (O), and the probability of being detected (D). These three parameters were multiplied to calculate risk priority numbers (RPNs), which were used to prioritize remedial measures. Failure modes with RPN≥200 were deemed as high risk, meaning that they needed immediate corrective action. After modifications that were put, we compared the resulting RPN with the previous one. A total of 33 failure modes were identified. Many of the failure modes, including the one with the highest RPN (specimen hemolysis) appeared in the pre-analytic phase, whereas no high-risk failure modes (RPN≥200) were found during the analytic phase. High-priority risks were "sample hemolysis" (RPN, 336), "sample delivery delay" (RPN, 225), "sample volume error" (RPN, 210), "failure to release results in a timely manner" (RPN, 210), and "failure to identify or report critical results" (RPN, 200). The

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

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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

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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

Clinical effect of Fuzheng quyu therapy in patients undergoing ...

African Journals Online (AJOL)

Clinical effect of Fuzheng quyu therapy in patients undergoing radiotherapy after cervical carcinoma surgery. ... The clinical effects and the incidence of adverse events were compared between the groups. Results: The plasma prothrombin time and activated partial thromboplastin time improved after treatment in the study ...

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) ...

Distribution of cow-calf producers' beliefs about reporting cattle with clinical signs of foot-and-mouth disease to a veterinarian before or during a hypothetical outbreak.

Science.gov (United States)

Delgado, Amy H; Norby, Bo; Scott, H Morgan; Dean, Wesley; McIntosh, W Alex; Bush, Eric

2014-12-01

Understanding the prevalence of cattle producers' beliefs regarding disease reporting can help officials improve surveillance programs with passive data collection. A cross-sectional survey was conducted in Texas in 2008 and 2009 to determine beliefs about reporting cattle with clinical signs consistent with foot-and-mouth disease (FMD) either prior to (scenario 1) or during an on-going outbreak of FMD (scenario 2). Two questionnaires were developed and distributed to Texas cow-calf producers in order to evaluate their behavioral, control, and normative beliefs related to disease reporting. The context for each behavior was provided through the use of scenarios, and belief strength was measured using a 7-point Likert-like scale. Beliefs were compared across scenarios and demographic categories, and the effect of scenario on belief examined using ordinal logistic regression. Respondents agreed that reporting clinically suspect cases would have positive economic and emotional consequences; however, when an outbreak was known to be present, producers were less likely to agree with many of the positive outcomes of reporting. Important barriers to disease reporting indicated by producers included a lack of knowledge related to clinical signs of highly contagious cattle diseases and which cattle are at risk of contracting FMD. In general, beliefs about barriers to reporting did not differ based on scenario. Veterinarians and regulatory authorities were the groups perceived to most strongly expect disease reporting, regardless of the scenario. Risk education for producers related to clinical signs of reportable livestock diseases, post-reporting procedures, and an understanding of FMD introduction and spread may improve the reporting of cattle with clinical signs consistent with FMD. Published by Elsevier B.V.

[The effects of Omega-3 fatty acids in clinical medicine].

Science.gov (United States)

Reiner, Martin F; Stivala, Simona; Camici, Giovanni G; Beer, Jürg H

2014-03-12

Effects of Omega-3 fatty acids (n-3 FA) in particular on the development of cardiovascular disease (CVD) are of major interest. Many experimental studies reported their anti-inflammatory, anti-thrombotic and anti-atherosclerotic properties and suggested favourable effects on the prevention of CVD. While the majority of former studies showed a benefit of n-3 FA acid intake, recent clinical trials using n-3 supplements on top of established medication and prudent nutrition did not confirm these findings. The conflicting data may be due to several factors such as the selection of study population with different sizes or characteristics as well as choosing different doses or types of n-3 FA. The most recent meta-analyses observed clear benefits of fish consumption, but not of n-3 capsules intake. Furthermore, a nutrition rich in plant-derived n-3 FA alpha-linolenic acid has been found to have beneficial effects on the development of cardio- and cerebrovascular diseases.

Augmenting retention and stability of an occlusal device for a partially dentate patient using existing extracoronal attachments: a clinical report.

Science.gov (United States)

Al-Rowaieh, Saleh A

2011-04-01

Occlusal devices are a valid treatment modality in certain clinical situations. For an occlusal device to be effective, sufficient retention and stability should be derived from coverage of the occlusal and incisal surfaces of the teeth. In the absence of most or all of the posterior teeth, the effectiveness of the device could become compromised as the incisal portions of the anterior teeth are typically not conducive to adequately retaining and stabilizing the device. This clinical report describes an approach to improving the retention and stability of an occlusal device for a patient with shortened dental arches by use of the patient's existing extracoronal attachments. Copyright © 2011 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

Evaluating the MEDLINE Core Clinical Journals filter: data-driven evidence assessing clinical utility.

Science.gov (United States)

Klein-Fedyshin, Michele; Ketchum, Andrea M; Arnold, Robert M; Fedyshin, Peter J

2014-12-01

MEDLINE offers the Core Clinical Journals filter to limit to clinically useful journals. To determine its effectiveness for searching and patient-centric decision making, this study compared literature used for Morning Report in Internal Medicine with journals in the filter. An EndNote library with references answering 327 patient-related questions during Morning Report from 2007 to 2012 was exported to a file listing variables including designated Core Clinical Journal, Impact Factor, date used and medical subject. Bradford's law of scattering was applied ranking the journals and reflecting their clinical utility. Recall (sensitivity) and precision of the Core Morning Report journals and non-Core set was calculated. This study applied bibliometrics to compare the 628 articles used against these criteria to determine journals impacting decision making. Analysis shows 30% of clinically used articles are from the Core Clinical Journals filter and 16% of the journals represented are Core titles. When Bradford-ranked, 55% of the top 20 journals are Core. Articles sources used. Among the 63 Morning Report subjects, 55 have <50% precision and 41 have <50% recall including 37 subjects with 0% precision and 0% recall. Low usage of publications within the Core Clinical Journals filter indicates less relevance for hospital-based care. The divergence from high-impact medicine titles suggests clinically valuable journals differ from academically important titles. With few subjects demonstrating high recall or precision, the MEDLINE Core Clinical Journals filter may require a review and update to better align with current clinical needs. © 2014 John Wiley & Sons, Ltd.

Management of bruxism-induced complications in removable partial denture wearers using specially designed dentures: a clinical report.

Science.gov (United States)

Baba, Kazuyoshi; Aridome, Kumiko; Pallegama, Ranjith Wasantha

2008-01-01

In patients with a limited number of remaining teeth, bruxism force can be destructive for both the remaining teeth and periodontal structures. This paper reports the successful management of four such patients with severe sleep bruxism, using conventional removable partial dentures and specially designed, splint-like removable partial dentures called a night denture. The night denture was fabricated in two different designs, which depended upon the pattern of the remaining tooth contacts. The patients were followed up for 2-6 years using a night denture in either of the two designs. Within the limitations of these four reports of clinical cases, the night denture appeared to be effective in managing the problems related to sleep bruxism.

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.

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.

Acute unintentional intoxication with paraffin in a 25-year old patient - clinical case report.

Science.gov (United States)

Chibishev, Andon; Simonovska, Natasa

2014-08-01

"Fire-breathing" or "fire-eating" is a special kind of street art where the acts are always stunning, spectacular and amazing. People exhibiting this kind of show are professionals, not rare amateurs, who use different kind of fuels, usually hydrocarbons, in order to produce a pillar of fire. Intoxications caused by ingestion or inhalation of liquid paraffin, used as a fuel while performing, are numerous and various. We present a clinical case report of a 25-year old, previously healthy, amateur "fire-breather". During October, 2010 this young men arrived at the Emergency Unit of the University Clinic for toxicology and Urgent Internal Medicine in a severe clinical condition, after his unsuccessful attempt to perform real "fire-breathing". He had fever, strong headaches, mild abdominal and chest pain and he also had difficulties breathing and persistent dry cough. The patient was extremely dyspneic with peripheral cyanosis and shortness of breath. "Fire-breathers" must be viewed as a population at risk of paraffin-induced pneumonia, which has low mortality rate, but still is related with numerous and various chronic complications. Our patient was first in a life threatening, extremely serious clinical condition which was urgently treated with appropriate vigorous and effective therapy. This therapeutic protocol led to successful full recovery of these young men, who luckily didn't exhibit any chronic complications. Copyright © 2014 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Psychosocial impact, perceived stress and learning effect in undergraduate dental students during transition from pre-clinical to clinical education.

Science.gov (United States)

Frese, C; Wolff, D; Saure, D; Staehle, H J; Schulte, A

2018-04-10

This study aimed to develop a suitable instrument for a comprehensive quantitative and qualitative assessment of perceived psychosocial impact, levels of stress and learning effect in undergraduate dental students during the transition from pre-clinical to clinical education. These findings might improve curricular structures and didactic organisation during this period. At the beginning of their first clinical year, undergraduate dental students were asked to complete an anonymous forty-item questionnaire. Two hundred and seventy-six undergraduate dental students were willing to participate and completed the questionnaire and participated during the years 2011-2016. The response rate was between 45% and 96%. Correlational analysis (Spearman-Rho) in the field of psychosocial impact showed the dental teacher to be the most important multiplier of students' feelings. If the students feel that their teacher acts cooperatively, positive items increase and negative items decrease significantly (P < .0001). Also, students who report high levels of stress are affected significantly in their psychosocial interaction (P < .0001). Wilcoxon test yielded highest levels of stress in endodontology during the first weeks (P < .0001). During the same period, the greatest learning increment was seen for diagnostics and caries excavation. In conclusion, teaching of undergraduate dental students during the transition period from pre-clinical to clinical education can be positively influenced by a supportive learning environment and by specific chronological modifications in the curriculum. Students should start their clinical training with diagnostics, preventive dentistry and initial periodontal treatment. Due to high levels of perceived stress, endodontology should be introduced later in the clinical curriculum. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Instruction in medical ethics during clinical training for medical students. Report on experience in radio-oncology

International Nuclear Information System (INIS)

Schaefer, C.; Lenk, C.; Koelbl, O.

2006-01-01

The article gives a review of the current state of education in medical ethics in Germany. The issue is considered from the viewpoint of radio-oncology. Both the pertinent literature and our own experience in teaching medical ethics are presented. In October 2003, medical ethics was integrated into the curriculum of medicine. The aim was to train competence in the field of personal attitudes and to intensify skills of moral reasoning. Our own experiences are positive, which is in accordance with the reports of other working groups. Most of the students were interested in education in medical ethics and looked upon ethical training as being an important part of their studies. Medical students are interested in ethical education during the clinical period of their studies, which has been taken into account since the actual change of the curriculum. Radio-oncologists as specialists in other clinical fields can offer important contributions when they discuss clinical cases from the viewpoint of medical ethics. The long-term effect of such an education will become the subject of future research. (orig.) [de

Lack of Effect of Sodium Benzoate at Reported Clinical Therapeutic Concentration on d-Alanine Metabolism in Dogs.

Science.gov (United States)

Popiolek, Michael; Tierney, Brendan; Steyn, Stefanus J; DeVivo, Michael

2018-06-19

Cognitive decline and psychosis have been hypothesized to be mediated by N-methyl-d-aspartate receptor (NMDAR) hypofunction. Consistent with this hypothesis, chronic treatment with d-alanine, a coagonist at the glycine site of the NMDAR, leads to an improvement of positive and cognitive symptoms in schizophrenic patients. d-alanine is oxidized by d-amino acid oxidase (DAAO); thus, an inhibitor of DAAO would be expected to enhance d-alanine levels and likewise lead to desirable clinical outcomes. Sodium benzoate, on the basis of d-amino acid inhibition, was observed to display beneficial clinical effects in schizophrenic and Alzheimer's patients. However, in the clinical pilot studies using sodium benzoate, d-amino acids were not quantified to verify that sodium benzoate's efficacy was mediated through DAAO inhibition. In this study, d-alanine content was monitored in cerebral spinal fluid (CSF) of dogs treated with daily injections of d-alanine (30 mg/kg) alone and in combination with sodium benzoate (30 mg/kg) for seven consecutive days. We reasoned that the cerebral spinal fluid d-alanine quantity is reflective of the brain d-alanine levels and it would increase as a consequence of DAAO inhibition with sodium benzoate. We found that d-alanine treatment lead to maximal concentration of 7.51 μM CSF d-alanine level; however, coadministration of sodium benzoate and d-alanine did not change CSF d-alanine level beyond that of d-alanine treatment alone. As a consequence, we conclude that clinical efficacy associated with chronic administration of sodium benzoate in schizophrenic and Alzheimer's patients is likely not mediated through inhibition of DAAO.

Aspects of matrix effects in applications of liquid chromatography-mass spectrometry to forensic and clinical toxicology--a review.

Science.gov (United States)

Peters, Frank T; Remane, Daniela

2012-06-01

In the last decade, liquid chromatography coupled to (tandem) mass spectrometry (LC-MS(-MS)) has become a versatile technique with many routine applications in clinical and forensic toxicology. However, it is well-known that ionization in LC-MS(-MS) is prone to so-called matrix effects, i.e., alteration in response due to the presence of co-eluting compounds that may increase (ion enhancement) or reduce (ion suppression) ionization of the analyte. Since the first reports on such matrix effects, numerous papers have been published on this matter and the subject has been reviewed several times. However, none of the existing reviews has specifically addressed aspects of matrix effects of particular interest and relevance to clinical and forensic toxicology, for example matrix effects in methods for multi-analyte or systematic toxicological analysis or matrix effects in (alternative) matrices almost exclusively analyzed in clinical and forensic toxicology, for example meconium, hair, oral fluid, or decomposed samples in postmortem toxicology. This review article will therefore focus on these issues, critically discussing experiments and results of matrix effects in LC-MS(-MS) applications in clinical and forensic toxicology. Moreover, it provides guidance on performance of studies on matrix effects in LC-MS(-MS) procedures in systematic toxicological analysis and postmortem toxicology.

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.

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.

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....

Effective use of technology in clinical supervision

Directory of Open Access Journals (Sweden)

Priya Martin

2017-06-01

Full Text Available Clinical supervision is integral to continuing professional development of health professionals. With advances in technology, clinical supervision too can be undertaken using mediums such as videoconference, email and teleconference. This mode of clinical supervision is termed as telesupervision. While telesupervision could be useful in any context, its value is amplified for health professionals working in rural and remote areas where access to supervisors within the local work environment is often diminished. While telesupervision offers innovative means to undertake clinical supervision, there remain gaps in the literature in terms of its parameters of use in clinical practice. This article outlines ten evidence-informed, practical tips stemming from a review of the literature that will enable health care stakeholders to use technology effectively and efficiently while undertaking clinical supervision. By highlighting the “how to” aspect, telesupervision can be delivered in the right way, to the right health professional, at the right time.

Proton Radiotherapy for Parameningeal Rhabdomyosarcoma: Clinical Outcomes and Late Effects

Energy Technology Data Exchange (ETDEWEB)

Childs, Stephanie K. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Kozak, Kevin R. [Department of Radiation Oncology, University of Wisconsin Cancer Center Johnson Creek, Madison, WI (United States); Friedmann, Alison M. [Department of Pediatric Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Yeap, Beow Y. [Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Adams, Judith; MacDonald, Shannon M.; Liebsch, Norbert J.; Tarbell, Nancy J. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Yock, Torunn I., E-mail: tyock@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States)

2012-02-01

Purpose: To report the clinical outcome and late side effect profile of proton radiotherapy in the treatment of children with parameningeal rhabdomyosarcoma (PM-RMS). Methods and Materials: Seventeen consecutive children with PM-RMS were treated with proton radiotherapy at Massachusetts General Hospital between 1996 and 2005. We reviewed the medical records of all patients and asked referring physicians to report specific side effects of interest. Results: Median patient age at diagnosis was 3.4 years (range, 0.4-17.6). Embryonal (n = 11), alveolar (n = 4), and undifferentiated (n = 2) histologies were represented. Ten patients (59%) had intracranial extension. Median prescribed dose was 50.4 cobalt gray equivalents (GyRBE) (range, 50.4-56.0 GyRBE) delivered in 1.8-2.0-GyRBE daily fractions. Median follow-up was 5.0 years for survivors. The 5-year failure-free survival estimate was 59% (95% confidence interval, 33-79%), and overall survival estimate was 64% (95% confidence interval, 37-82%). Among the 7 patients who failed, sites of first recurrence were local only (n = 2), regional only (n = 2), distant only (n = 2), and local and distant (n = 1). Late effects related to proton radiotherapy in the 10 recurrence-free patients (median follow-up, 5 years) include failure to maintain height velocity (n = 3), endocrinopathies (n = 2), mild facial hypoplasia (n = 7), failure of permanent tooth eruption (n = 3), dental caries (n = 5), and chronic nasal/sinus congestion (n = 2). Conclusions: Proton radiotherapy for patients with PM-RMS yields tumor control and survival comparable to that in historical controls with similar poor prognostic factors. Furthermore, rates of late effects from proton radiotherapy compare favorably to published reports of photon-treated cohorts.

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

Science.gov (United States)

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.

Population-based open-label clinical effectiveness assessment of the cysteinyl leukotriene receptor antagonist pranlukast

Directory of Open Access Journals (Sweden)

Gen Tamura

2000-01-01

Full Text Available Although the efficacy of cysteinyl leukotriene receptor antagonists in asthma therapy has been established through controlled clinical trials, there are no data concerning the effectiveness of their use in clinical practice, in which there is no rigid selection based on specific inclusion and exclusion criteria. The aim of the present study was to evaluate the effectiveness of pranlukast in clinical practice. More than 2500 outpatients with mild to severe persistent asthma answered an input questionnaire, which consisted of 33 items assessing asthma symptoms in terms of six activities of daily living during the previous 2 weeks. Of these patients, 1138 received treatment with pranlukast and answered the same questionnaire 4–6 weeks after the start of treatment. In 923 of these 1138 patients, we examined the impact of concomitantly used inhaled steroids, β2-adrenergic agonists or sustained-release theophylline on the effectiveness of pranlukast treatment. One hundred and sixty-seven control patients completed the questionnaire twice but did not receive pranlukast treatment. We found a significant decrease in the number of asthma symptoms reported among both the 1138 patients treated with pranlukast and the 167 control patients. However, the magnitude of the decrease in symptoms was significantly (P < 0.001 greater with pranlukast treatment. Moreover, pranlukast was equally efficacious in the presence and absence of concomitantly used inhaled steroids, β2-adrenergic agonists or sustained-release theophylline. In conclusion, pranlukast was shown to have clinical effectiveness in the treatment of mild to severe persistent asthma symptoms.

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.

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.

Characteristics of effective clinical guidelines for general practice.

NARCIS (Netherlands)

Burgers, J.S.; Grol, R.P.T.M.; Zaat, J.O.M.; Spies, T.H.; Bij, A.K. van der; Mokkink, H.G.A.

2003-01-01

BACKGROUND: The use of clinical guidelines in general practice is often limited. Research on barriers to guideline adherence usually focuses on attitudinal factors. Factors linked to the guideline itself are much less studied. AIM: To identify characteristics of effective clinical guidelines for

Measuring and reporting of the treatment effect of hormonal emergency contraceptives.

Science.gov (United States)

Leung, Vivian W Y; Soon, Judith A; Levine, Marc

2012-03-01

To derive summary estimates of observed pregnancy rates in women who used the Yuzpe or levonorgestrel emergency contraceptive regimen and identify the various ways in which data related to regimen effectiveness were reported, to discuss the limitations of the effectiveness estimates as they are currently reported, and to propose alternative reporting methods that are less susceptible to misinterpretation. Analysis of pooled data from 34 experimental or observational studies that had an explicit method of follow-up to systematically evaluate pregnancy outcome after a single course of emergency contraception treatment within a given menstrual cycle. Women who took either the Yuzpe or levonorgestrel emergency contraceptive regimen to prevent pregnancy. We searched the MEDLINE and EMBASE databases for clinical studies that systematically evaluated pregnancy outcomes of women who used the Yuzpe or levonorgestrel regimen for emergency contraception. The effectiveness of these regimens is typically reported in relative terms as the reduction of pregnancy risk from a theoretical baseline risk. We reported the effectiveness using absolute risk reductions and numbers needed to treat. We pooled relevant data by using the β-binomial method to derive observed pregnancy rates. The pooled observed pregnancy rates for studies of the Yuzpe and levonorgestrel regimens were 2.0% (95% confidence interval [CI] 1.5-2.5%) and 1.7% (95% CI 1.2-2.2%), respectively. Against expected pregnancy rates of 4-8%, relative emergency contraceptive effectiveness ranges were 50.0-75.0% and 57.5-78.8% for the Yuzpe and levonorgestrel regimens, respectively. Absolute risk reductions were 2.0-6.0% and 2.3-6.3%, respectively. This means that 17-50 women would need to have received the Yuzpe regimen and 16-43 women the levonorgestrel regimen to prevent one pregnancy. Emergency contraception effectiveness data are susceptible to misinterpretation when data are reported in relative terms without the

Effectiveness of one dose of mumps vaccine against clinically diagnosed mumps in Guangzhou, China, 2006–2012

OpenAIRE

Fu, Chuanxi; Xu, Jianxiong; Cai, Yuanjun; He, Qing; Zhang, Chunhuan; Chen, Jian; Dong, Zhiqiang; Hu, Wensui; Wang, Hui; Zhu, Wei; Wang, Ming

2013-01-01

Although mumps-containing vaccines were introduced in China in 1990s, mumps continues to be a public health concern due to the lack of decline in reported mumps cases. To assess the mumps vaccine effectiveness (VE) in Guangzhou, China, we performed a 1:1 matched case-control study. Among children in Guangzhou aged 8 mo to 12 y during 2006 to 2012, we matched one healthy child to each child with clinically diagnosed mumps. Cases with clinically diagnosed mumps were identified from surveillance...

Clinical multiphoton tomography and clinical two-photon microendoscopy

Science.gov (United States)

König, Karsten; Bückle, Rainer; Weinigel, Martin; Elsner, Peter; Kaatz, Martin

2009-02-01

We report on applications of high-resolution clinical multiphoton tomography based on the femtosecond laser system DermaInspectTM with its flexible mirror arm in Australia, Asia, and Europe. Applications include early detection of melanoma, in situ tracing of pharmacological and cosmetical compounds including ZnO nanoparticles in the epidermis and upper dermis, the determination of the skin aging index SAAID as well as the study of the effects of anti-aging products. In addition, first clinical studies with novel rigid high-NA two-photon 1.6 mm GRIN microendoscopes have been conducted to study the effect of wound healing in chronic wounds (ulcus ulcera) as well as to perform intrabody imaging with subcellular resolution in small animals.

Effect, Feasibility, and Clinical Relevance of Cell Enrichment in Large Volume Fat Grafting: A Systematic Review.

Science.gov (United States)

Rasmussen, Bo Sonnich; Lykke Sørensen, Celine; Vester-Glowinski, Peter Viktor; Herly, Mikkel; Trojahn Kølle, Stig-Frederik; Fischer-Nielsen, Anne; Drzewiecki, Krzysztof Tadeusz

2017-07-01

Large volume fat grafting is limited by unpredictable volume loss; therefore, methods of improving graft retention have been developed. Fat graft enrichment with either stromal vascular fraction (SVF) cells or adipose tissue-derived stem/stromal cells (ASCs) has been investigated in several animal and human studies, and significantly improved graft retention has been reported. Improvement of graft retention and the feasibility of these techniques are equally important in evaluating the clinical relevance of cell enrichment. We conducted a systematic search of PubMed to identify studies on fat graft enrichment that used either SVF cells or ASCs, and only studies reporting volume assessment were included. A total of 38 articles (15 human and 23 animal) were included to investigate the effects of cell enrichment on graft retention as well as the feasibility and clinical relevance of cell-enriched fat grafting. Improvements in graft retention, the SVF to fat (SVF:fat) ratio, and the ASC concentration used for enrichment were emphasized. We proposed an increased retention rate greater than 1.5-fold relative to nonenriched grafts and a maximum SVF:fat ratio of 1:1 as the thresholds for clinical relevance and feasibility, respectively. Nine studies fulfilled these criteria, whereof 6 used ASCs for enrichment. We found no convincing evidence of a clinically relevant effect of SVF enrichment in humans. ASC enrichment has shown promising results in enhancing graft retention, but additional clinical trials are needed to substantiate this claim and also determine the optimal concentration of SVF cells/ASCs for enrichment. 4. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

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.

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

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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.

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

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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.

The clinical effectiveness of preimplantation genetic diagnosis for aneuploidy in all 24 chromosomes (PGD-A): systematic review.

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Lee, Evelyn; Illingworth, Peter; Wilton, Leeanda; Chambers, Georgina Mary

2015-02-01

Is preimplantation genetic diagnosis for aneuploidy (PGD-A) with analysis of all chromosomes during assisted reproductive technology (ART) clinically and cost effective? The majority of published studies comparing a strategy of PGD-A with morphologically assessed embryos have reported a higher implantation rate per embryo using PGD-A, but insufficient data has been presented to evaluate the clinical and cost-effectiveness of PGD-A in the clinical setting. Aneuploidy is a leading cause of implantation failure, miscarriage and congenital abnormalities in humans, and a significant cause of ART failure. Preclinical evidence of PGD-A indicates that the selection and transfer of euploid embryos during ART should improve clinical outcomes. A systematic review of the literature was performed for full text English language articles using MEDLINE, EMBASE, SCOPUS, Cochrane Library databases, NHS Economic Evaluation Database and EconLit. The Downs and Black scoring checklist was used to assess the quality of studies. Clinical effectiveness was measured in terms of pregnancy, live birth and miscarriage rates. Nineteen articles meeting the inclusion criteria, comprising three RCTs in young and good prognosis patients and 16 observation studies were identified. Five of the observational studies included a control group of patients where embryos were selected based on morphological criteria (matched cohort studies). Of the five studies that included a control group and reported implantation rates, four studies (including two RCTs) demonstrated improved implantation rates in the PGD-A group. Of the eight studies that included a control group, six studies (including two RCTs) reported significantly higher pregnancy rates in the PGD-A group, and in the remaining two studies, equivalent pregnancies rates were reported despite fewer embryos being transferred in the PGD-A group. The three RCTs demonstrated benefit in young and good prognosis patients in terms of clinical pregnancy rates

High-end clinical domain information systems for effective healthcare delivery.

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Mangalampalli, Ashish; Rama, Chakravarthy; Muthiyalian, Raja; Jain, Ajeet K

2007-01-01

The Electronic Health Record (EHR) provides doctors with a quick, reliable, secure, real-time and user-friendly source of all relevant patient data. The latest information system technologies, such as Clinical Data Warehouses (CDW), Clinical Decision-Support (CDS) systems and data-mining techniques (Online Analytical Processing (OLAP) and Online Transactional Processing (OLTP)), are used to maintain and utilise patient data intelligently, based on the users' requirements. Moreover, clinical trial reports for new drug approvals are now being submitted electronically for faster and easier processing. Also, information systems are used in educating patients about the latest developments in medical science through the internet and specially configured kiosks in hospitals and clinics.

Epidermolysis bullosa acquisita: clinical manifestations, microscopic findings, and surgical periodontal therapy. A case report.

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Hakki, S S; Celenligil-Nazliel, H; Karaduman, A; Usubütün, A; Ertoy, D; Ayhan, A; Ruacan, S

2001-04-01

Epidermolysis bullosa acquisita (EBA) is an uncommon, acquired, chronic subepidermal bullous disease. This report describes a case of EBA with gingival involvement. A 43-year-old woman with EBA was referred to our clinic for periodontal therapy because of gingival tenderness and bleeding. She has been on cyclosporin A therapy for the last 2 years. Clinical findings were analyzed. Anterior gingivectomy operations were performed in 2 stages. The samples obtained during the surgery were examined using histopathologic, immunohistologic, and electronmicroscopic methods. Long-term effects of the surgical periodontal treatment on gingiva were evaluated both clinically and microscopically. The dentition displayed minimal enamel hypoplasia. Decayed, missing, and filled surfaces score was found to be elevated. Periodontal examination showed generalized diffuse gingival inflammation and gingival enlargement localized mainly to the anterior region. Nikolsky's sign was positive. However, wound healing was uneventful after the operations. Microscopic findings were similar to those obtained from the skin. Twenty-one months after the operations, Nikolsky's sign was negative and no remarkable gingival inflammation was noted. Microscopic examination revealed that the blisters were fewer in number and smaller in size. These results indicate that gingival tissues may also be involved in EBA. Uneventful wound healing after periodontal surgery in this case suggests that periodontal surgery can be performed in patients with EBA. Moreover, both our clinical and histopathologic findings imply that gingivectomy proves useful in maintaining gingival integrity in these patients. Our data may also suggest that the patients with EBA are highly likely to develop dental caries.

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

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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.

Effects of Ramadan Fasting on Spirometric Values and Clinical Symptoms in Asthmatic Patients

Directory of Open Access Journals (Sweden)

Abdolreza Norouzy

2013-07-01

Full Text Available Introduction: Ramadan is the 9th Islamic lunar month during which Muslims avoid eating and drinking from sunrise to sunset. The effect of Ramadan intermittent fasting on asthma control is controversial. The aim of this study was to investigate the effects of Ramadan fasting on the spirometric variables and clinical symptoms on well-controlled asthmatic patients during Ramadan. Material and Methods: a cohort study was conducted in Mashhad, Khorasan Razavi, Iran. Twenty-nine (19 females and 10 males well-controlled asthmatic patients aged 47 (12 years completed the study. The average duration of fasting was 26.5 days. Assessment of spirometric variables (daily peak expiratory flow, peak expiratory flow variability, peak expiratory flow home monitoring as well as asthma clinical symptoms including dyspnea, cough, wheezing, and chest tightness were carried out. Results: No significant changes in clinical symptoms were reported in asthmatic patients at the end of Ramadan fasting. Among spirometric variables, only peak expiratory flow improved after Ramadan (p <0.05. There was a reduction in the mean peak expiratory flow variability from 13% at the first week of fasting to 10% at the fourth week (p <0.05. Conclusion: In well-controlled asthmatic patients, Ramadan fasting resulted in improvement in peak expiratory flow and peak expiratory flow variability.

The effect of blinding on estimates of mortality in randomised clinical trials of intensive care interventions

DEFF Research Database (Denmark)

Anthon, Carl Thomas; Granholm, Anders; Perner, Anders

2017-01-01

INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not apply......(s). For each intervention, we will compare summary mortality effect estimates in blinded versus unblinded trials. ETHICS AND DISSEMINATION: This research does not require ethical approval as we will use summary data from trials already approved by relevant ethical institutions. We will report the results...... in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and submit the final paper to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO, registration number: CRD42017056212....

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

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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.

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

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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.

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

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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.

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...

Student and faculty perceptions of effective clinical instructors in ADN programs.

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Gignac-Caille, A M; Oermann, M H

2001-11-01

The purpose of this study was to identify the perceptions of associate degree nursing (ADN) students and faculty of characteristics of effective clinical teachers and determine whether there were differences between these two groups. A survey was conducted of 292 students in various levels of their ADN programs and 59 faculty members from the same five programs, which were randomly selected from across Michigan. Data were collected using the Nursing Clinical Effectiveness Inventory, which includes 48 characteristics of effective clinical instructors arranged in five subscales. Students identified "demonstrates clinical skills and judgment" as the most important characteristic of effective clinical instructors, while faculty identified "explains clearly" as the most important characteristic. There was agreement on 6 of the top 10 characteristics identified by both groups. Both groups rated "directs student to useful literature in nursing" as the least important characteristic of effective clinical instructors. The students' and faculty's perceptions of effective clinical instructors differed by subscales, with students identifying evaluation characteristics as most important (mean = 4.73, SD = .42) and faculty identifying interpersonal relationships as most important (mean = 4.72, SD = .31). A t test indicated a significant difference between student and faculty means for the interpersonal relationships subscales, with faculty rating this group of characteristics as more important than students did (t = 2.49, p = .0 14).

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.

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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/

Piracetam-induced changes on the brainstem auditory response in anesthetized juvenile rhesus monkeys (Macaca mulatta). Report of two clinical cases.

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Durand-Rivera, A; Gonzalez-Pina, R; Hernandez-Godinez, B; Ibanez-Contreras, A; Bueno-Nava, A; Alfaro-Rodriguez, A

2012-10-01

We describe two clinical cases and examine the effects of piracetam on the brainstem auditory response in infantile female rhesus monkeys (Macaca mulatta). We found that the interwave intervals show a greater reduction in a 3-year-old rhesus monkey compared to a 1-year-old rhesus monkey. In this report, we discuss the significance of these observations. © 2012 John Wiley & Sons A/S.

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

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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.

Mechanical and geometric features of endodontic instruments and its clinical effect

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Hyeon-Cheol Kim

2011-01-01

Full Text Available Introduction The aim of this paper is to discuss the mechanical and geometric features of Nickel-titanium (NiTi rotary files and its clinical effects. NiTi rotary files have been introduced to the markets with their own geometries and claims that they have better ability for the root canal shaping than their competitors. The contents of this paper include the (possible interrelationship between the geometries of NiTi file (eg. tip, taper, helical angle, etc and clinical performance of the files as follows; - Fracture modes of NiTi rotary files - Non-cutting guiding tip and glide path - Taper and clinical effects - Cross-sectional area and clinical effects - Heat treatments and surface characteristics - Screw-in effect and preservation of root dentin integrity - Designs for reducing screw-in effect Conclusions Based on the reviewed contents, clinicians may have an advice to use various brands of NiTi rotary instruments regarding their advantages which would fit for clinical situation.

Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

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Curran, Geoffrey M; Bauer, Mark; Mittman, Brian; Pyne, Jeffrey M; Stetler, Cheryl

2012-03-01

This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.

Prolactinomas : clinical studies

NARCIS (Netherlands)

Kars, Marleen

2008-01-01

Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

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

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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.

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.

Pattern of breast diseases: preliminary report of breast clinic

International Nuclear Information System (INIS)

Siddiqui, K.; Rasool, I.

2001-01-01

Objective: To find out the pattern of breast disease in this part of the county and create public awareness about breast diseases especially cancer. Design: Ac cross sectional and cohort study. Place and Duration of Study: The study was conducted at Department of Surgery, Jinnah Hospital /Allama Iqbal Medical College, Lahore from March 1999 to July 2000. Subjects and Methods: All the female patients reported were included in this study. They were diagnosed by history, physical examination and rel event investigations like ultrasonography, mammography, FNAS and biopsy. Appropriate medical and surgical management was carried out. The breast cancer was treated according to TNA staging system by multidisciplinary approach. Method of breast self examination (BSE) was taught with the help of charts and brochures. Results: The age ranged from 10 years to 75 years. Maximum number of patients (30%) was seen between 20-29 years of age while 15 (1%) cases did not suffer from any disease. Among 1485 patients the common conditions were non cyclical mastalgia in 362 (24.37%), fibroadenoma in 289 (19.46%), fibrocystic disease in 276(17.98%) breast abscess in 149 (10%) and breast cancer (6.19%). Other diseases were puberty mastitis 49(3.2%), galactocele 40(2.69%), accessory breast 45(3%) and nipple discharge 28(1.88%). Among the palpable lumps, breast caner accounted for 11.75%. The commonest age of presentation of breast cancer was 5th decade (31%) followed by 4th decade (26%). Majority of cancer patients (45%) presented in stage III. All the women with beast abscesses were lactating. Non cyclical mastalgia was commonly seen in 4th decade (30.66%) while 44.63% patients of fibroadenoma reported in the 2nd decade. Fibrocystic disease was reported between 3rd and 4th decade (62.17%). Conclusion: Commonest being conditions were non cyclical mastalgia followed by fibroadenoma while breast cancer contributed a significant percentage of palpable lumps. Due to effective public awareness

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

Anti-N-Methyl-d-Aspartate receptor (NMDAR) encephalitis during pregnancy: Clinical analysis of reported cases.

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Shi, Yan-Chao; Chen, Xiu-Ju; Zhang, Hong-Mei; Wang, Zhen; Du, Da-Yong

2017-06-01

To analyze the clinical features of 13 pregnant patients with anti-N-Methyl-d-Aspartate receptor (NMDAR) encephalitis. Retrospective review of thirteen reported cases was conducted for anti-NMDAR encephalitis patients during pregnancy. The clinical data were collected from papers published in PubMed prior to 16 February 2016. Statistical analysis of the data was performed, which encompasses the patients' age, past medical history, onset of symptoms, concomitant with ovarian teratomas, immunotherapy, outcomes of mothers and newborns. Thirteen cases were reported in 11 articles with a median age of 23 (interquartile range, 19-27) years old. There were eight cases in which the onset periods of gestation happened in the first trimester and five cases in the second trimester. Among 13 cases, five patients had a past medical history, one concomitant with autoimmune Graves' hyperthyroidism, one with bilateral ovarian teratomas removed history, one with anti-NMDAR encephalitis five years before pregnancy and two with psychiatric symptoms. Five patients were found with ovarian teratomas. Seven patients responded to first-line immunotherapy whereas all of two patients responded to second-line immunotherapy when the first-line immunotherapy failed. Following up all the 13 patients, most experienced a substantial recovery, except one had spasticity and dystonia in one hand, and one died of a superimposed infection. Three fetuses were miscarried or aborted in total. Most newborns were healthy, except two cases (2/10) with abnormal neurologic signs. Clinical analysis of the data indicates that most patients respond to first-line immunotherapy. A second-line immunotherapy is effective when first-line immunotherapy fails. It has also been found that most mothers and newborns can have good outcomes. Copyright © 2017. Published by Elsevier B.V.

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.

Prevalence and reporting of recruitment, randomisation and treatment errors in clinical trials: A systematic review.

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Yelland, Lisa N; Kahan, Brennan C; Dent, Elsa; Lee, Katherine J; Voysey, Merryn; Forbes, Andrew B; Cook, Jonathan A

2018-06-01

Background/aims In clinical trials, it is not unusual for errors to occur during the process of recruiting, randomising and providing treatment to participants. For example, an ineligible participant may inadvertently be randomised, a participant may be randomised in the incorrect stratum, a participant may be randomised multiple times when only a single randomisation is permitted or the incorrect treatment may inadvertently be issued to a participant at randomisation. Such errors have the potential to introduce bias into treatment effect estimates and affect the validity of the trial, yet there is little motivation for researchers to report these errors and it is unclear how often they occur. The aim of this study is to assess the prevalence of recruitment, randomisation and treatment errors and review current approaches for reporting these errors in trials published in leading medical journals. Methods We conducted a systematic review of individually randomised, phase III, randomised controlled trials published in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Annals of Internal Medicine and British Medical Journal from January to March 2015. The number and type of recruitment, randomisation and treatment errors that were reported and how they were handled were recorded. The corresponding authors were contacted for a random sample of trials included in the review and asked to provide details on unreported errors that occurred during their trial. Results We identified 241 potentially eligible articles, of which 82 met the inclusion criteria and were included in the review. These trials involved a median of 24 centres and 650 participants, and 87% involved two treatment arms. Recruitment, randomisation or treatment errors were reported in 32 in 82 trials (39%) that had a median of eight errors. The most commonly reported error was ineligible participants inadvertently being randomised. No mention of recruitment, randomisation

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

Science.gov (United States)

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…

The effectiveness of educational supervisors from the viewpoints of nurse managers and clinical nurses

Directory of Open Access Journals (Sweden)

M Khodayarian

2012-09-01

Full Text Available Introduction: The educational supervisors should attempt to plan and implement nurses’ development programs according to the principles of educational process. The present study was conducted to assess the effectiveness of educational supervisors from the viewpoints of clinical nurses and nurse managers in 2007. Methods : 97 clinical nurses and 33 nurse managers in educational hospitals of Yazd participated in this cross sectional study. The questionnaire including 56 items related to expected professional competencies of educational supervisor was prepared and its validity and reliability was confirmed. Overall Cronbach’s alpha was 0.97 ranging from 0.77 to 0.96 for different dimensions which indicated internal consistency of the questionnaire. Results: The results showed 42.3% of nurses considered the function of their hospital as effective, 52.6% as ineffective, and 5.2% as relatively effective. One hundred percent of metrons considered the function of educational supervisors as effective. All the educational supervisors considered their function effective. The study samples reported that all the listed criteria were important in the effectiveness of educational supervisors’ function. Conclusion: In order to improve the effectiveness of educational supervisors’ function their management and leadership competencies should be developed. Competency-based approach is suggested in preparing educational supervisors for implementing the educational process from the problem solving skills. This will help nurse managers to make their work environments a learning and educational institute.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

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Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

2015-05-01

A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

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

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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.

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

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

2017-02-01

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

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.

Effective choices for diagnostic imaging in clinical practice. Excerpts from a report of a WHO Scientific Group on Clinical Diagnostic Imaging

International Nuclear Information System (INIS)

1992-01-01

There are so many different methods of diagnostic imaging that medical practitioners may need guidance to choose the best through the maze of options for each clinical problem. Advice may be required for more than just the first choice, because the first imaging procedure does not always give the desired answer and, depending on the results, further imaging may have to undertaken. The alternative is to submit the patient to a barrage of imaging and hope that one type, at least provides the diagnosis. This is a quite unacceptable way to practice medicine because of the cost and the risk of radiation damage from unnecessary examinations. The choice of the most effective imaging is often difficult and frequently controversial. The sequence to be followed vries with many factors: the equipment available, the skills of the practitioner, the expected quality of the results, the quality of interpretation, and conclusion which can be drawn

Proton Therapy in Children: A Systematic Review of Clinical Effectiveness in 15 Pediatric Cancers

Energy Technology Data Exchange (ETDEWEB)

Leroy, Roos, E-mail: Roos.leroy@kce.fgov.be [Belgian Healthcare Knowledge Centre (KCE), Brussels (Belgium); Benahmed, Nadia; Hulstaert, Frank [Belgian Healthcare Knowledge Centre (KCE), Brussels (Belgium); Van Damme, Nancy [Belgian Cancer Registry, Brussels (Belgium); De Ruysscher, Dirk [Department of Radiation Oncology, University of Leuven, Leuven (Belgium)

2016-05-01

Because it spares many normal tissues and reduces the integral dose, proton therapy (PT) is the preferred tumor irradiation technique for treating childhood cancer. However, to the best of our knowledge, no systematic review of the clinical effectiveness of PT in children has been reported in the scientific literature. A systematic search for clinical outcome studies on PT published between 2007 and 2015 was performed in Medline (through OVID), EMBASE, and the Cochrane Library. Twenty-three primary studies were identified, including approximately 650 patients overall. The median/mean follow-up times were limited (range, 19-91 months). None of the studies were randomized, 2 were comparative, and 20 were retrospective. Most suffered from serious methodologic limitations, yielding a very low level of clinical evidence for the outcomes in all indications. For example, for retinoblastoma, very low-level evidence was found that PT might decrease the incidence of second malignancies. For chondrosarcoma, chordoma, craniopharyngioma, ependymoma, esthesioneuroblastoma, Ewing sarcoma, central nervous system germinoma, glioma, medulloblastoma, osteosarcoma, and rhabdomyosarcoma, there was insufficient evidence to either support or refute PT in children. For pelvic sarcoma (ie, nonrhabdomyosarcoma and non-Ewing sarcoma), pineal parenchymal tumor, primitive neuroectodermal tumor, and “adult-type” soft tissue sarcoma, no studies were identified that fulfilled the inclusion criteria. Although there is no doubt that PT reduces the radiation dose to normal tissues and organs, to date the critical clinical data on the long-term effectiveness and harm associated with the use of PT in the 15 pediatric cancers under investigation are lacking. High-quality clinical research in this area is needed.

Cerebellar Ataxia with Complete Clinical Recovery and Resolution of MRI Lesions Related to Central Pontine Myelinolysis: Case Report and Literature Review

Directory of Open Access Journals (Sweden)

Cristina Dolciotti

2010-12-01

Full Text Available There are several reports of central pontine myelinolysis (CPM in a setting of malnutrition, alcoholism, and chronic debilitating illness associated with electrolyte abnormalities, especially hyponatremia. The cause of myelinolysis is still under debate, and, although osmotic effects are thought to be responsible in most cases, alternative pathological factors should be considered [King et al.: Am J Med Sci 2010;339:561–567]. We report a case of CPM in a patient with recent chemotherapy for colon cancer without electrolyte unbalance and otherwise unexplained causes. Moreover, the present case is an example of the unusual clinical ataxic variant, followed by complete recovery without any specific treatment. The diagnosis was confirmed by MRI, which showed a characteristic hyperintense signal abnormality in the central part of the pons with an unaffected outer rim. One month later, we observed complete resolution of clinical and radiological symptoms.

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 ...

Developing Effective Clinical Trainers

Directory of Open Access Journals (Sweden)

Kevin Khamarko

2012-05-01

Full Text Available Continuing education and training provides a means to improve performance among health care professionals (HCP. Research shows, however, that continuing professional education activities have inconsistent effects on HCP competence, performance, and patient health outcomes. Furthermore, the trainer’s role as a facilitator of knowledge translation (KT has been understudied. To understand how clinical trainers support their trainees in translating what they learned into practice, we conducted 16 in-depth interviews with expert trainers. These interviews yielded a variety of KT-enhancing strategies, including tailoring training activities to their trainees’ needs. In addition, participants recommended trainers familiarize themselves with their trainees’ work environments, be able to identify their knowledge deficits, and devote time to provide trainees with post-training support. Creating an effective training, one that leads to transfer, requires active planning, communication, and command of the training topic by skilled trainers.

Clinical Application of Nape Acupuncture

Institute of Scientific and Technical Information of China (English)

HUA Xiao-yin; CUI Yi-jun

2003-01-01

@@ Nape Acupuncture refers to an acupuncture method at nuchal region. It was initiated and applied in clinic by Dr. HUA Yan-ling from Shanghai Research Institute of Acupuncture and Meridian and it can be used for treating diseases of nervous, circulatory and motor systems. Especially, it is more effective for brain-origin diseases. The author ever studied this acupuncture method from Dr. Hua and found it was effective according to clinical application. Now several typical cases are reported as follows.

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

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...

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

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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.

Teaching Effectiveness: Preparing Occupational Therapy Students for Clinical Practice

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Jane C. OBrien PhD, MS.MEdL, OTR/L

2013-06-01

Full Text Available Medical educators must examine the ability of teaching methodologies to prepare students for clinical practice. Two types of assessment methods commonly used in medical education include the Short Objective Structured Clinical Examination (OSCE and the Integrated Performance Procedural Instrument (IPPI. The use of these methods in occupational therapy (OT education is less understood. With the increasing number of students enrolled in programs, faculty face challenges to examine how clinical competence is established using data to determine teaching effectiveness. This study examines two educational methodologies used in OT curriculum: the long written case study (IPPI and short performance-based OSCE. The authors describe the effectiveness of each examination as it relates to student performance in clinical practice (as measured by the Fieldwork Performance Evaluation [FWPE]. The findings obtained from separate focus group sessions with faculty and students further provide insight into the advantages and disadvantages of the educational methodologies.

A Simplified Technique for Orientation of a Bone Anchored Auricular Prostheses: a Clinical Report

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Hussein G. El Charkawi

2012-08-01

Full Text Available Background: A simple technique was presented in this clinical report for orientation of a bone anchored auricular prosthesis.Methods: The proposed technique includes drawing the intact ear on a transparent celluloid paper or radiographic film and flipping it to the opposite side and relating it to the fixed anatomical features on the face of patient.Results: The drawing, by this way provides a simple and easy way to duplicate and transfer the exact size and position of the intact ear to the defect side.Conclusions: This technique provides a simple, safe, inexpensive and time saving yet, an accurate and effective surgical template that orients the craniofacial implants to the confines of the definitive auricular prosthesis. It is indicated for restoration of single missing external ear either in aplasia, injuries and total resection.

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.

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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

Evidence base of clinical studies on Tai Chi: a bibliometric analysis.

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Guo-Yan Yang

Full Text Available BACKGROUND: The safety and health benefits of Tai Chi mind-body exercise has been documented in a large number of clinical studies focused on specific diseases and health conditions. The objective of this systematic review is to more comprehensively summarize the evidence base of clinical studies of Tai Chi for healthcare. METHODS AND FINDINGS: We searched for all types of clinical studies on Tai chi in PubMed, the Cochrane Library and four major Chinese electronic databases from their inception to July 2013. Data were analyzed using SPSS17.0 software. A total of 507 studies published between 1958 and 2013 were identified, including 43 (8.3% systematic reviews of clinical studies, 255 (50.3% randomized clinical trials, 90 (17.8% non-randomized controlled clinical studies, 115 (22.7% case series and 4 (0.8% case reports. The top 10 diseases/conditions was hypertension, diabetes, osteoarthritis, osteoporosis or osteopenia, breast cancer, heart failure, chronic obstructive pulmonary disease, coronary heart disease, schizophrenia, and depression. Many healthy participants practiced Tai Chi for the purpose of health promotion or preservation. Yang style Tai Chi was the most popular, and Tai Chi was frequently practiced two to three 1-hour sessions per week for 12 weeks. Tai Chi was used alone in more than half of the studies (58.6%, while in other studies Tai Chi was applied in combination with other therapies including medications, health education and other physical therapies. The majority of studies (94.1% reported positive effects of Tai Chi, 5.1% studies reported uncertain effects and 0.8% studies reported negative effects. No serious adverse events related to Tai Chi were reported. CONCLUSIONS: The quantity and evidence base of clinical studies on Tai Chi is substantial. However, there is a wide variation in Tai Chi intervention studied and the reporting of Tai Chi intervention needs to be improved. Further well-designed and reported studies

Effectiveness and safety of probiotic preparations in clinical treatment of inflammatory bowel disease

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Ewa Wasilewska

2018-03-01

Full Text Available Inflammatory bowel disease (IBD is characterized by an aggressive immune response to luminal antigens including those of commensal microbiota, which are essential for intestinal homeostasis and appear to play a role in tolerance and immunity. Its disturbances can result in intestinal dysbiosis and the development of disease. The precise role of luminal bacteria in the pathogenesis of IBD has yet to be elucidated; however, considerable evidence implicates changes to bacterial communities associated with the gut mucosa in the disease state. It is also well known that beneficial microbes can confer a functional health benefit to the host. We analysed the effectiveness of probiotics to relieve symptoms in patients suffering from IBD. Using the Medline database and manually searching articles, we reviewed clinical trials performed with probiotics and lactic acid bacteria as supportive or alternative IBD treatments. The article summarizes IBD microenvironment and the efficiency of probiotic preparations in attenuating the symptoms of Crohn’s disease, ulcerative colitis, and pouchitis. The safety of probiotic intake is also analyzed based on existing outcomes of clinical trials and case reports. Strong evidence exists that probiotics are effective as supportive therapy for IBD; however, only a few preparations have well documented efficiency and safety. Clinical studies demonstrated that probiotics were more effective in preventing recurrence of the disease symptoms than in the management of its active stage. Some products may increase the risk of complications in specific patient groups; therefore, the use of probiotics should be considered with caution in the case of severe active IBD, especially with disrupted mucosa.

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

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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.

Involving clinical librarians at the point of care: results of a controlled intervention.

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Aitken, Elizabeth M; Powelson, Susan E; Reaume, Renée D; Ghali, William A

2011-12-01

To measure the effect of including a clinical librarian in the health care team on medical residents and clinical clerks. In 2009, medical residents and clinical clerks were preassigned to one of two patient care teams (intervention and control). Each team had a month-long rotation on the general medicine teaching unit. The clinical librarian joined the intervention team for morning intake, clinical rounding, or an afternoon patient list review, providing immediate literature searches, formal group instruction, informal bedside teaching, and/or individual mentoring for use of preappraised resources and evidence-based medicine search techniques. Both intervention and control teams completed pre and post surveys comparing their confidence levels and awareness of resources as well as their self-reported use of evidence for making patient care decisions. The nonintervention team was surveyed as the control group. The clinical librarian intervention had a significant positive effect on medical trainees' self-reported ability to independently locate and evaluate evidence resources to support patient care decisions. Notably, 30 of 34 (88%) reported having changed a treatment plan based on skills taught by the clinical librarian, and 27 of 34 (79%) changed a treatment plan based on the librarian's mediated search support. Clinical librarians on the care team led to positive effects on self-reported provider attitudes, provider information retrieval tendencies, and, notably, clinical decision making. Future research should evaluate economic effects of widespread implementation of on-site clinical librarians.

Clinical and patient-reported outcomes of bilateral implantation of a +2.5 diopter multifocal intraocular lens.

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Maxwell, Andrew; Holland, Edward; Cibik, Lisa; Fakadej, Anna; Foster, Gary; Grosinger, Les; Moyes, Andrew; Nielsen, Stephen; Silverstein, Steven; Toyos, Melissa; Weinstein, Arthur; Hartzell, Scott

2017-01-01

To assess the effectiveness and safety of a multifocal intraocular lens (IOL) with +2.5 diopter (D) additional power compared with a monofocal IOL. Fifteen sites in the United States. Prospective randomized patient- and observer-masked clinical trial. Randomized patients received multifocal or monofocal IOLs bilaterally. Visual acuity (33 cm, 40 cm, 53 cm, 60 cm, 4 m) was measured; safety was assessed through adverse event rates. Patient-reported visual outcomes were evaluated using the Visual Tasks questionnaire. The frequency and severity of visual disturbances were evaluated using the Assessment of Photic Phenomena and Lens EffectS questionnaire. The multifocal IOL (n = 155) provided better corrected distance visual acuity at 53 cm than the monofocal IOL (n = 165) (0.322 versus 0.512 logMAR; between-group difference, -0.190 logMAR; P < .0001) and 40 cm but not at 4 m. Ocular adverse event rates were less than 3.84% in both groups. Serious adverse event rates were comparable between the 2 IOL types. Patients with multifocal IOLs reported less difficulty with near tasks (with and without correction) and intermediate tasks (without correction). Difficulty with extended-intermediate and distance tasks was similar between groups. The most frequently reported self-rated severe phenomena were halos, starbursts, and glare. Most patients (monofocal ≥72%; multifocal ≥73%) reported never experiencing blurred, distorted, or double vision. The +2.5 D multifocal IOL provided better vision at 40 cm and 53 cm and similar vision at 4 m compared with the monofocal IOL. Safety profiles and visual phenomena were comparable between groups. Copyright © 2017 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Barriers to implementation of a computerized decision support system for depression: an observational report on lessons learned in "real world" clinical settings

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Sunderajan Prabha

2009-01-01

Full Text Available Abstract Background Despite wide promotion, clinical practice guidelines have had limited effect in changing physician behavior. Effective implementation strategies to date have included: multifaceted interventions involving audit and feedback, local consensus processes, marketing; reminder systems, either manual or computerized; and interactive educational meetings. In addition, there is now growing evidence that contextual factors affecting implementation must be addressed such as organizational support (leadership procedures and resources for the change and strategies to implement and maintain new systems. Methods To examine the feasibility and effectiveness of implementation of a computerized decision support system for depression (CDSS-D in routine public mental health care in Texas, fifteen study clinicians (thirteen physicians and two advanced nurse practitioners participated across five sites, accruing over 300 outpatient visits on 168 patients. Results Issues regarding computer literacy and hardware/software requirements were identified as initial barriers. Clinicians also reported concerns about negative impact on workflow and the potential need for duplication during the transition from paper to electronic systems of medical record keeping. Conclusion The following narrative report based on observations obtained during the initial testing and use of a CDSS-D in clinical settings further emphasizes the importance of taking into account organizational factors when planning implementation of evidence-based guidelines or decision support within a system.

Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a.

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Rudick, R A; Pace, A; Rani, M R S; Hyde, R; Panzara, M; Appachi, S; Shrock, J; Maurer, S L; Calabresi, P A; Confavreux, C; Galetta, S L; Lublin, F D; Radue, E-W; Ransohoff, R M

2009-06-09

Findings from a small clinical study suggested that statins may counteract the therapeutic effects of interferon beta (IFNbeta) in patients with relapsing-remitting multiple sclerosis (RRMS). We conducted a post hoc analysis of data from the Safety and Efficacy of Natalizumab in Combination With IFNbeta-1a in Patients With Relapsing-Remitting Multiple Sclerosis (SENTINEL) study to determine the effects of statins on efficacy of IFNbeta. SENTINEL was a prospective trial of patients with RRMS treated with natalizumab (Tysabri, Biogen Idec, Inc., Cambridge, MA) plus IM IFNbeta-1a (Avonex, Biogen Idec, Inc.) 30 microg compared with placebo plus IM IFNbeta-1a 30 microg. Clinical and MRI outcomes in patients treated with IM IFNbeta-1a only (no-statins group, n = 542) were compared with those of patients taking IM IFNbeta-1a and statins at doses used to treat hyperlipidemia (statins group, n = 40). No significant differences were observed between treatment groups in adjusted annualized relapse rate (p = 0.937), disability progression (p = 0.438), number of gadolinium-enhancing lesions (p = 0.604), or number of new or enlarging T2-hyperintense lesions (p = 0.802) at 2 years. More patients in the statins group reported fatigue, extremity pain, muscle aches, and increases in hepatic transaminases compared with patients in the no-statins group. Statin treatment had no ex vivo or in vitro effect on induction of IFN-stimulated genes. Statin therapy does not appear to affect clinical effects of IM interferon beta-1a in patients with relapsing-remitting multiple sclerosis or the primary molecular response to interferon beta treatment.

Effect of Objective Structured Clinical Examination on Nursing Students' Clinical Skills

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Seyedeh Narjes Mousavizadeh

2018-01-01

Full Text Available Considering the daily increasing changes in clinical training approaches, the necessity of using new evaluation methods in proportion with these approaches is also becoming more and more obvious for measuring all of the cognitive, emotional and psychomotor dimensions of students. The present study was designed and conducted for reviewing the effect of objective structured clinical examination method on the clinical skills of nursing students. In this quasi-experimental study, 48 nursing students have participated that were randomly assigned to two groups of intervention and control. The intervention group students were evaluated at the end of educational period of their clinical skills and principles course using objective structured clinical examination (OSCE. The OSCE included five core skills in this course: assessing and fulfilling patients’ basic needs, dressing up, injectable drug therapy, noninjectable drug therapy, infection control. The control group students were evaluated using the routine method. Both groups of students were followed up in the next semester and were compared in terms of learning enhancement in these five skills. Evaluation of procedures was based on valid and reliable check-lists made by the researcher. Results were analyzed using descriptive and inferential statistics (Chi-square, independent and paired T tests. The mean score of the final evaluation in the intervention group was significantly higher than that of the control group (P= 0.000. Final evaluation scores of the intervention group students showed a better performance than their previous semester (P= 0.000, while the final evaluation scores of the control group students showed a lack of progress in their skills (P<0.05. It seems that this evaluation method also is a support for students' learning and resulted in improvement of clinical skills among them. Accordingly, it is recommended that nursing education centers apply this method to assess students�

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

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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

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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.

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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

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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

Effectiveness of a Simulated Clinical Examination in the Assessment of the Clinical Competencies of Entry-Level Trainees in a Family Medicine Residency Programme

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Curran, Vernon R.; Butler, Roger; Duke, Pauline; Eaton, William H.; Moffatt, Scott M.; Sherman, Greg P.; Pottle, Madge

2012-01-01

Clinical competence is a multidimensional concept and encompasses a variety of skills including procedural, problem-solving and clinical judgement. The initial stages of postgraduate medical training are believed to be a particularly important time for the development of clinical skill competencies. This study reports on an evaluation of a…

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

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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

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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.

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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.

Side effects of stabilization occlusal splints: a report of three cases and literature review.

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Magdaleno, Fernando; Ginestal, Eduardo

2010-04-01

Stabilization splints are frequently used for the treatment of temporomandibular disorders (TMD) and bruxism, despite the fact that little is known about their mechanism of action or the precise conditions under which they can be recommended. Moreover, information about their possible adverse effects, which in the majority of cases include occlusal modifications of little clinical relevance, is scarce. On occasions, these splints can provoke severe occlusal alterations and other complications, which are rarely alluded to in the literature. Here presented in this paper are three case reports in which part-time stabilization splints led to irreversible occlusal alterations and a discussion of the relevant clinical implications. Such splints are reported to negatively affect the condyle-disk relation in patients who exhibit disk displacement with reduction and to modify breathing features in patients with obstructive sleep apnea, although further studies are required to unequivocally demonstrate these findings. Finally, the splint seems to modify peripheral information at the level of the Central Nervous System, leading to modifications in corporal postural tone. The clinical repercussions of such alterations are currently poorly understood. It is our hope that future research will throw fresh light on these important topics.

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 ...

Systematic review of model-based analyses reporting the cost-effectiveness and cost-utility of cardiovascular disease management programs.

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Maru, Shoko; Byrnes, Joshua; Whitty, Jennifer A; Carrington, Melinda J; Stewart, Simon; Scuffham, Paul A

2015-02-01

The reported cost effectiveness of cardiovascular disease management programs (CVD-MPs) is highly variable, potentially leading to different funding decisions. This systematic review evaluates published modeled analyses to compare study methods and quality. Articles were included if an incremental cost-effectiveness ratio (ICER) or cost-utility ratio (ICUR) was reported, it is a multi-component intervention designed to manage or prevent a cardiovascular disease condition, and it addressed all domains specified in the American Heart Association Taxonomy for Disease Management. Nine articles (reporting 10 clinical outcomes) were included. Eight cost-utility and two cost-effectiveness analyses targeted hypertension (n=4), coronary heart disease (n=2), coronary heart disease plus stoke (n=1), heart failure (n=2) and hyperlipidemia (n=1). Study perspectives included the healthcare system (n=5), societal and fund holders (n=1), a third party payer (n=3), or was not explicitly stated (n=1). All analyses were modeled based on interventions of one to two years' duration. Time horizon ranged from two years (n=1), 10 years (n=1) and lifetime (n=8). Model structures included Markov model (n=8), 'decision analytic models' (n=1), or was not explicitly stated (n=1). Considerable variation was observed in clinical and economic assumptions and reporting practices. Of all ICERs/ICURs reported, including those of subgroups (n=16), four were above a US$50,000 acceptability threshold, six were below and six were dominant. The majority of CVD-MPs was reported to have favorable economic outcomes, but 25% were at unacceptably high cost for the outcomes. Use of standardized reporting tools should increase transparency and inform what drives the cost-effectiveness of CVD-MPs. © The European Society of Cardiology 2014.

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.

Clinical utility of curcumin extract.

Science.gov (United States)

Asher, Gary N; Spelman, Kevin

2013-01-01

Turmeric root has been used medicinally in China and India for thousands of years. The active components are thought to be the curcuminoids, primarily curcumin, which is commonly available worldwide as a standardized extract. This article reviews the pharmacology of curcuminoids, their use and efficacy, potential adverse effects, and dosage and standardization. Preclinical studies point to mechanisms of action that are predominantly anti-inflammatory and antineoplastic, while early human clinical trials suggest beneficial effects for dyspepsia, peptic ulcer, inflammatory bowel disease, rheumatoid arthritis, osteoarthritis, uveitis, orbital pseudotumor, and pancreatic cancer. Curcumin is well-tolerated; the most common side effects are nausea and diarrhea. Theoretical interactions exist due to purported effects on metabolic enzymes and transport proteins, but clinical reports do not support any meaningful interactions. Nonetheless, caution, especially with chemotherapy agents, is advised. Late-phase clinical trials are still needed to confirm most beneficial effects.

Educational interventions to improve quality of life in people with chronic inflammatory skin diseases: systematic reviews of clinical effectiveness and cost-effectiveness.

Science.gov (United States)

Pickett, Karen; Loveman, Emma; Kalita, Neelam; Frampton, Geoff K; Jones, Jeremy

2015-10-01

psoriasis. Carers of children in one RCT of eczema showed improvement in HRQoL; however, in a RCT evaluating a website intervention there were no demonstrable effects on HRQoL. Neither the RCT in those adults with acne nor the RCT in those adults with mixed skin conditions demonstrated an effect on HRQoL. One RCT reported subgroups with atopic dermatitis or psoriasis and education was effective for psoriasis only. Other outcomes also showed mixed results. It is unclear how clinically meaningful any of the observed improvements are. Three studies of cost-effectiveness were included. The interventions, comparators and populations varied across the studies and, overall, the studies provided limited information on cost-effectiveness. The studies did provide detailed information on resources and costs that could be useful to inform a future cost-effectiveness evaluation in this area. The application of the inclusion criterion around whether the interventions were aimed at improving HRQoL or the inference that they could improve HRQoL was difficult as information was rarely reported. There is uncertainty regarding whether educational interventions addressing issues that could improve HRQoL in people with chronic skin conditions are effective. Tentative conclusions about the best approach to delivering these kinds of interventions are that face-to-face, group, sessions may be beneficial; however, text messages may also be effective. Delivery over a period of time and by a multidisciplinary team may also be associated with positive outcomes. There is uncertainty over whether or not educational interventions are cost-effective. This study is registered as PROSPERO CRD42014007426. The National Institute for Health Research Health Technology Assessment programme.

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

Net benefits: assessing the effectiveness of clinical networks in Australia through qualitative methods

Directory of Open Access Journals (Sweden)

Cunningham Frances C

2012-11-01

network effectiveness at community, network, and member levels during the network’s timeline, and on the role of networks and their contribution. Overall, stakeholders reported positive momentum and useful progress in network growth and development, and saw their networks as providing valuable mechanisms for meeting instrumental goals and pursuing collaborative interests. Network forms can prove their utility in addressing ‘wicked problems,’ and these Australian clinical networks present a practical approach to the difficult issue of clinician engagement in state-level implementation of best practice for improving patient care and outcomes.

Net benefits: assessing the effectiveness of clinical networks in Australia through qualitative methods.

Science.gov (United States)

Cunningham, Frances C; Ranmuthugala, Geetha; Westbrook, Johanna I; Braithwaite, Jeffrey

2012-11-02

In the 21st century, government and industry are supplementing hierarchical, bureaucratic forms of organization with network forms, compatible with principles of devolved governance and decentralization of services. Clinical networks are employed as a key health policy approach to engage clinicians in improving patient care in Australia. With significant investment in such networks in Australia and internationally, it is important to assess their effectiveness and sustainability as implementation mechanisms. In two purposively selected, musculoskeletal clinical networks, members and stakeholders were interviewed to ascertain their perceptions regarding key factors relating to network effectiveness and sustainability. We adopted a three-level approach to evaluating network effectiveness: at the community, network, and member levels, across the network lifecycle. Both networks studied are advisory networks displaying characteristics of the 'enclave' type of non-hierarchical network. They are hybrids of the mandated and natural network forms. In the short term, at member level, both networks were striving to create connectivity and collaboration of members. Over the short to medium term, at network level, both networks applied multi-disciplinary engagement in successfully developing models of care as key outputs, and disseminating information to stakeholders. In the long term, at both community and network levels, stakeholders would measure effectiveness by the broader statewide influence of the network in changing and improving practice. At community level, in the long term, stakeholders acknowledged both networks had raised the profile, and provided a 'voice' for musculoskeletal conditions, evidencing some progress with implementation of the network mission while pursuing additional implementation strategies. This research sheds light on stakeholders' perceptions of assessing clinical network effectiveness at community, network, and member levels during the network

Patients' Values in Clinical Decision-Making.

Science.gov (United States)

Faggion, Clovis Mariano; Pachur, Thorsten; Giannakopoulos, Nikolaos Nikitas

2017-09-01

Shared decision-making involves the participation of patient and dental practitioner. Well-informed decision-making requires that both parties understand important concepts that may influence the decision. This fourth article in a series of 4 aims to discuss the importance of patients' values when a clinical decision is made. We report on how to incorporate important concepts for well-informed, shared decision-making. Here, we present patient values as an important issue, in addition to previously established topics such as the risk of bias of a study, cost-effectiveness of treatment approaches, and a comparison of therapeutic benefit with potential side effects. We provide 2 clinical examples and suggestions for a decision tree, based on the available evidence. The information reported in this article may improve the relationship between patient and dental practitioner, resulting in more well-informed clinical decisions. Copyright © 2017 Elsevier Inc. All rights reserved.

Nursing Students’ Perceptions on Characteristics of an Effective Clinical Instructor

Directory of Open Access Journals (Sweden)

Joan E. Niederriter PhD, MSN, CMSRN, RN-BC

2017-01-01

Full Text Available Purpose To identify characteristics and teaching techniques of effective clinical instructors that can be utilized or implemented to improve the student nurse clinical experience. Background The clinical instructor is an integral part of a quality clinical experience. They help students transfer didactic information to the practice setting. The clinical nursing experience is a vital component in the developmental process of the nursing student. Research has been done on this subject, but gaps remain. The need for a more in-depth understanding of students’ perceptions of the characteristics and teaching techniques that best aid their comprehension and learning will help instructors to maximize student learning experiences in the practice setting. Method This qualitative research study utilized the phenomenological research method. Three open-ended questions were posed to 14 nursing students to identify the characteristics and teaching techniques they believed comprised an effective clinical instructor. Individual interviews were conducted and transcribed interviews were reviewed to identify common themes. Three faculty members provided member checking to prevent bias by reviewing the transcribed interviews for common themes. Findings Participants identified four main themes which include a trusting relationship, experience or knowledge, coach, and role model. The students found that they gained more knowledge, developed more critical thinking, and felt more confident with instructors who utilized characteristics and techniques from these four areas. Conclusion Clinical instructors play an important role in preparing the student nurse in becoming a competent nurse in the practice setting. This information can be used to provide a foundation in creating an educational opportunity to inform nurse educators in the ways to become a more effective clinical instructor.

Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes

Directory of Open Access Journals (Sweden)

Mehrfam Khoshkhounejad

2015-11-01

Full Text Available Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes.

Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder

DEFF Research Database (Denmark)

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

2014-01-01

, respectively. We also found publication bias in relation to beneficial effects. CONCLUSION: Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There were inconsistencies between protocols and clinical study reports and within.......gov and the manufacturer's online clinical trial registry were searched for trial results. RESULTS: Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor...... clinical study reports. Clinical study reports should be used as the data source for systematic reviews of drugs, but they should first be checked against protocols and within themselves for accuracy and consistency....

Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation.

Science.gov (United States)

Melendez-Torres, G J; Auguste, Peter; Armoiry, Xavier; Maheswaran, Hendramoorthy; Court, Rachel; Madan, Jason; Kan, Alan; Lin, Stephanie; Counsell, Carl; Patterson, Jacoby; Rodrigues, Jeremy; Ciccarelli, Olga; Fraser, Hannah; Clarke, Aileen

2017-09-01

At the time of publication of the most recent National Institute for Health and Care Excellence (NICE) guidance [technology appraisal (TA) 32] in 2002 on beta-interferon (IFN-β) and glatiramer acetate (GA) for multiple sclerosis, there was insufficient evidence of their clinical effectiveness and cost-effectiveness. To undertake (1) systematic reviews of the clinical effectiveness and cost-effectiveness of IFN-β and GA in relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) and clinically isolated syndrome (CIS) compared with best supportive care (BSC) and each other, investigating annualised relapse rate (ARR) and time to disability progression confirmed at 3 months and 6 months and (2) cost-effectiveness assessments of disease-modifying therapies (DMTs) for CIS and RRMS compared with BSC and each other. Searches were undertaken in January and February 2016 in databases including The Cochrane Library, MEDLINE and the Science Citation Index. We limited some database searches to specific start dates based on previous, relevant systematic reviews. Two reviewers screened titles and abstracts with recourse to a third when needed. The Cochrane tool and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and Philips checklists were used for appraisal. Narrative synthesis and, when possible, random-effects meta-analysis and network meta-analysis (NMA) were performed. Cost-effectiveness analysis used published literature, findings from the Department of Health's risk-sharing scheme (RSS) and expert opinion. A de novo economic model was built for CIS. The base case used updated RSS data, a NHS and Personal Social Services perspective, a 50-year time horizon, 2014/15 prices and a discount rate of 3.5%. Outcomes are reported as incremental cost-effectiveness ratios (ICERs). We undertook probabilistic sensitivity analysis. In total, 6420 publications were identified, of which 63 relating to 35 randomised

Clinical effectiveness, tolerability and cost-effectiveness of newer drugs for epilepsy in adults: a systematic review and economic evaluation.

Science.gov (United States)

Wilby, J; Kainth, A; Hawkins, N; Epstein, D; McIntosh, H; McDaid, C; Mason, A; Golder, S; O'Meara, S; Sculpher, M; Drummond, M; Forbes, C

2005-04-01

To examine the clinical effectiveness, tolerability and cost-effectiveness of gabapentin (GBP), lamotrigine (LTG), levetiracetam (LEV), oxcarbazepine (OXC), tiagabine (TGB), topiramate (TPM) and vigabatrin (VGB) for epilepsy in adults. Electronic databases. Internet resources. Pharmaceutical company submissions. Selected studies were screened and quality assessed. Separate analyses assessed clinical effectiveness, serious, rare and long-term adverse events and cost-effectiveness. An integrated economic analysis incorporating information on costs and effects of newer and older antiepileptic drugs (AEDs) was performed to give direct comparisons of long-term costs and benefits. A total of 212 studies were included in the review. All included systematic reviews were Cochrane reviews and of good quality. The quality of randomised controlled trials (RCTs) was variable. Assessment was hampered by poor reporting of methods of randomisation, allocation concealment and blinding. Few of the non-randomised studies were of good quality. The main weakness of the economic evaluations was inappropriate use of the cost-minimisation design. The included systematic reviews reported that newer AEDs were effective as adjunctive therapy compared to placebo. For newer versus older drugs, data were available for all three monotherapy AEDs, although data for OXC and TPM were limited. There was limited, poor-quality evidence of a significant improvement in cognitive function with LTG and OXC compared with older AEDs. However, there were no consistent statistically significant differences in other clinical outcomes, including proportion of seizure-free patients. No studies assessed effectiveness of AEDs in people with intellectual disabilities or in pregnant women. There was very little evidence to assess the effectiveness of AEDs in the elderly; no significant differences were found between LTG and carbamazepine monotherapy. Sixty-seven RCTs compared adjunctive therapy with placebo, older

Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.

Science.gov (United States)

Sices, Laura; Pawlowski, Katherine; Farfel, Laura; Phillips, Deirdre; Howe, Yamini; Cochran, David M; Choueiri, Roula; Forbes, Peter W; Brewster, Stephanie J; Frazier, Jean A; Neumeyer, Ann; Bridgemohan, Carolyn

2017-09-01

Recruitment and completion of research activities during regular clinical care has the potential to increase research participation in complex neurodevelopmental disorders. We evaluated the feasibility, and effect on clinical care, of conducting biomarker research within a subspecialty clinical visit for autism spectrum disorder (ASD). Children, aged 5 to 10 years, were recruited by providers in ASD clinics at 5 institutions. Biomarkers collected were growth measurements, head circumference, neurologic and dysmorphology examinations, digit ratio (2D:4D) measurement, and platelet serotonin and urinary melatonin sulfate excretion levels. Parents completed the Aberrant Behavior Checklist-Community and a medical/demographic questionnaire. Cognitive level was abstracted from the medical record. Parents and clinicians completed surveys on the effect of the study on the clinical visit. Eighty-three children and their caregivers participated. Factors limiting participation included difficulty reaching families by phone and parent concern about the study blood draw requirement. All children completed at least 4 of 7 planned research activities. Demographic factors, educational placement, and child behavior were not associated with completion of study activities. Lower nonverbal cognitive function was weakly associated with fewer activities completed. Forty-four percent of clinicians reported an effect of the research study on the clinical visit. However, neither parent-reported nor clinician-reported effect was associated with the degree of study activity completion. Recruiting study participants in the context of scheduled ASD clinical visits required significant effort. However, once recruited, participants completed most study activities, regardless of behavioral symptom severity. Research activities did not adversely affect the clinical visit.

A systematic review of assessment and intervention strategies for effective clinical communication in culturally and linguistically diverse students.

Science.gov (United States)

Chan, Annie; Purcell, Alison; Power, Emma

2016-09-01

Culturally and linguistically diverse (CALD) students often experience difficulties with the clinical communication skills that are essential for successful interactions in the workplace. However, there is little evidence on the effectiveness of assessment and intervention strategies for this population. The two aims of this study were: to evaluate the effectiveness of assessment tools in identifying and describing the clinical communication difficulties of CALD health care students; and to determine whether communication programmes improved their clinical communication skills. Systematic review based on the Cochrane protocol. Articles were identified through a search of established databases using MeSH and key search terms. Studies published in English from 1990 to March 2015 were included if they described assessment strategies or a training programme for communication skills of CALD students. Studies were excluded if they did not describe implementation of a specific assessment or intervention programme. Data were extracted independently by the first author and verified by the second author. Quality was measured by the Best Evidence Medical Education guide and the Educational Interventions Critical Appraisal Tool. The Kirkpatrick hierarchy was used to measure impact. Meta-analysis was not conducted because of the heterogeneity of programme design and outcome measures. One hundred and twenty-nine articles met the criteria for full text review. Eighty-six articles were excluded. Thirteen articles addressing assessment and 30 articles reporting on communication training programmes were included in this review. Assessment tools used rubrics and rating scales effectively. Intervention studies focused on speech and language skills (n = 20), interpersonal skills (n = 7) and faculty-level support (n = 5). Although 17 studies reported positive findings on student satisfaction, only eight reported improved skills post-training. The development of effective

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

Bias in clinical intervention research

DEFF Research Database (Denmark)

Gluud, Lise Lotte

2006-01-01

Research on bias in clinical trials may help identify some of the reasons why investigators sometimes reach the wrong conclusions about intervention effects. Several quality components for the assessment of bias control have been suggested, but although they seem intrinsically valid, empirical...... evidence is needed to evaluate their effects on the extent and direction of bias. This narrative review summarizes the findings of methodological studies on the influence of bias in clinical trials. A number of methodological studies suggest that lack of adequate randomization in published trial reports...

The clinical effectiveness and cost-effectiveness of home-based, nurse-led health promotion for older people: a systematic review.

Science.gov (United States)

Tappenden, P; Campbell, F; Rawdin, A; Wong, R; Kalita, N

2012-01-01

studies with respect to the nature of the intervention, the nurses delivering the programmes and the populations in which the interventions were assessed. Overall, the quality of the included studies was good: all but one of the included studies were judged to be at medium or low risk of bias. Meta-analysis of eight studies suggested a statistically significant mortality benefit for the home-based health promotion groups, whereas a meta-analysis of four studies suggested non-significant benefits in terms of fewer falls in the intervention groups than in the control groups. Positive outcomes for home-based, nurse-led health promotion interventions were also reported within individual studies across several other outcomes. Only three economic studies met the criteria for inclusion in the review of cost-effectiveness. This evidence base consists of one non-randomised cost minimisation analysis and two economic evaluations undertaken alongside randomised controlled trials. Two of these studies involved an intervention targeted specifically at patients with a known underlying incurable disease, whereas the third study examined the clinical effectiveness and cost-effectiveness of early discharge in patients with a range of conditions, including fractures, neurological conditions and cardiorespiratory conditions. Each study indicated some likelihood that home-based, nurse-led health promotion may offer cost savings to the NHS and associated sectors, such as social services. However, one study did not report any comparison of health outcomes and instead simply assumed equivalence between the intervention and comparator groups, whereas the other two studies suggested at best a negligible incremental benefit in terms of preference-based health-related quality-of-life measures. The evidence base for clinical effectiveness is subject to considerable heterogeneity. The UK economic evidence base is limited to three studies. On the basis of the evidence included in this systematic

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.

A systematic review of implementation strategies for assessment, prevention, and management of ICU delirium and their effect on clinical outcomes.

Science.gov (United States)

Trogrlić, Zoran; van der Jagt, Mathieu; Bakker, Jan; Balas, Michele C; Ely, E Wesley; van der Voort, Peter H J; Ista, Erwin

2015-04-09

Despite recommendations from professional societies and patient safety organizations, the majority of ICU patients worldwide are not routinely monitored for delirium, thus preventing timely prevention and management. The purpose of this systematic review is to summarize what types of implementation strategies have been tested to improve ICU clinicians' ability to effectively assess, prevent and treat delirium and to evaluate the effect of these strategies on clinical outcomes. We searched PubMed, Embase, PsychINFO, Cochrane and CINAHL (January 2000 and April 2014) for studies on implementation strategies that included delirium-oriented interventions in adult ICU patients. Studies were suitable for inclusion if implementation strategies' efficacy, in terms of a clinical outcome, or process outcome was described. We included 21 studies, all including process measures, while 9 reported both process measures and clinical outcomes. Some individual strategies such as "audit and feedback" and "tailored interventions" may be important to establish clinical outcome improvements, but otherwise robust data on effectiveness of specific implementation strategies were scarce. Successful implementation interventions were frequently reported to change process measures, such as improvements in adherence to delirium screening with up to 92%, but relating process measures to outcome changes was generally not possible. In meta-analyses, reduced mortality and ICU length of stay reduction were statistically more likely with implementation programs that employed more (six or more) rather than less implementation strategies and when a framework was used that either integrated current evidence on pain, agitation and delirium management (PAD) or when a strategy of early awakening, breathing, delirium screening and early exercise (ABCDE bundle) was employed. Using implementation strategies aimed at organizational change, next to behavioral change, was also associated with reduced mortality

The effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model.

Science.gov (United States)

Maddineshat, Maryam; Hashemi, Mitra; Besharati, Reza; Gholami, Sepideh; Ghavidel, Fatemeh

2018-01-01

Clinical experience associated with the fear and anxiety of nursing students in the psychiatric unit. Mental health nursing instructors find it challenging to teach nursing students to deal with patients with mental disorders in an environment where they need to provide patient teaching and clinical decision-making based on evidence and new technology. To measure the effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model evaluation in the psychiatry unit of Imam Reza Hospital, Bojnurd, Iran. This cross-sectional study was carried out from 2011 to 2016 on 76 nursing students from a university as part of a clinical mental health course in two semesters. The students were selected by a non-probable convenient sampling method. After completing their clinical education, each student responded to checklist questions based on the four-level Kirkpatrick's model evaluation and open questions relating to clinical supervision. Finally, all data was analyzed using the SPSS version 16. The students have evaluated clinical supervision as a useful approach, and appreciated the instructor's supportive behavior during teaching and imparting clinical skills. This has made them feel relaxed at the end of the clinical teaching course. In addition, in the evaluation through Kirkpatrick's model, more than 70% of the students have been satisfied with the method of conducting the teaching and average score of nursing students' attitude toward mental health students: Their mean self-confidence score was 18.33±1.69, and the mean score of their performance in the study was evaluated to be 93.74±5.3 from 100 points. The results of clinical mental health teaching through clinical supervision and Kirkpatrick's model evaluation show that the satisfaction, self-esteem, attitude, and skill of nursing students are excellent, thereby portraying the effectiveness of clinical teaching. But this program still needs to be reformed. To

Effects of limited midwifery clinical education and practice standardisation of student preparedness.

Science.gov (United States)

Vuso, Zanyiwe; James, Sindiwe

2017-08-01

To explore the perceptions of midwifery educators regarding effects of limited standardisation of midwifery clinical education and practice on clinical preparedness of midwifery students. Investigation of levels of clinical competency of students is a critical need in the current era. Such competency levels are especially important in midwifery practice in South Africa as there is a significant increase of maternal deaths and litigations in the country. Most of the deaths are in the primary healthcare level maternity units where the newly qualified midwives practise. These areas are mainly run by midwives only. The current article seeks to report the findings of the study that was conducted to investigate how midwifery educators prepare students adequately for clinical readiness. The study was conducted amongst midwifery nurse educators on three campuses of the Nursing College in the Eastern Cape. A qualitative, explorative, descriptive and contextual research design was used for the study. Seventeen purposively selected midwifery educators, with the researcher using set criteria, from a Nursing college in the Eastern Cape, were the participants in the study. Data was collected using focus-group interviews that were captured by means of an audio-voice recorder. Tesch's data-analysis method was used to develop themes and sub-themes. Trustworthiness of the study was ensured using the criteria of credibility, transferability, dependability and confirmability. Inconsistent clinical practice amongst midwifery educators in their clinical teaching and assessment were found to be the major factors resulting from limited standardisation. The inconsistent clinical practice and assessments of midwifery educators was found to lead to loss of the necessary skills required by the students which led them to perform poorly in their final clinical assessments. There are some barriers in the current clinical teaching and education strategy used in this college that prohibit the

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

Effectiveness and clinical inertia in patients with antidiabetic therapy.

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Machado-Duque, Manuel Enrique; Ramírez-Riveros, Adriana Carolina; Machado-Alba, Jorge Enrique

2017-06-01

To establish the effectiveness of antidiabetic therapy and the frequency of clinical inertia in the management of type 2 diabetes mellitus in Colombia. A cross-sectional study with follow-up of patients who had been treated for at least 1 year and were receiving medical consultation for antidiabetic treatment. Effectiveness was established when haemoglobin-A1c levels were inertia was reached, which was defined as no therapeutic modifications despite not achieving management controls. Sociodemographic, clinical and pharmacological variables were evaluated, and multivariate analyses were performed. In total, 363 patients with type 2 diabetes mellitus were evaluated, with a mean age of 62.0±12.2 years. A total of 1,016 consultations were evaluated, and the therapy was effective at the end of the follow-up in 57.9% of cases. Clinical inertia was found in 56.8% of patients who did not have metabolic control. The most frequently prescribed medications were metformin (84.0%), glibenclamide (23.4%) and insulin glargine (20.7%). Moreover, 57.6% of the patients were treated with two or more antidiabetic medications. Having metabolic control in the first consult of the follow-up was a protective factor against clinical inertia in the subsequent consultations (OR: 0.08; 95%CI: 0.04-0.15; Pinertia was identifiable and quantifiable and found in similar proportions to other countries. Clinical inertia is a relevant condition given that it interferes with the possibility of controlling this pathology. © 2017 John Wiley & Sons Ltd.

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.

Power analysis to detect treatment effects in longitudinal clinical trials for Alzheimer's disease.

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Huang, Zhiyue; Muniz-Terrera, Graciela; Tom, Brian D M

2017-09-01

Assessing cognitive and functional changes at the early stage of Alzheimer's disease (AD) and detecting treatment effects in clinical trials for early AD are challenging. Under the assumption that transformed versions of the Mini-Mental State Examination, the Clinical Dementia Rating Scale-Sum of Boxes, and the Alzheimer's Disease Assessment Scale-Cognitive Subscale tests'/components' scores are from a multivariate linear mixed-effects model, we calculated the sample sizes required to detect treatment effects on the annual rates of change in these three components in clinical trials for participants with mild cognitive impairment. Our results suggest that a large number of participants would be required to detect a clinically meaningful treatment effect in a population with preclinical or prodromal Alzheimer's disease. We found that the transformed Mini-Mental State Examination is more sensitive for detecting treatment effects in early AD than the transformed Clinical Dementia Rating Scale-Sum of Boxes and Alzheimer's Disease Assessment Scale-Cognitive Subscale. The use of optimal weights to construct powerful test statistics or sensitive composite scores/endpoints can reduce the required sample sizes needed for clinical trials. Consideration of the multivariate/joint distribution of components' scores rather than the distribution of a single composite score when designing clinical trials can lead to an increase in power and reduced sample sizes for detecting treatment effects in clinical trials for early AD.

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

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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.

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

Directory of Open Access Journals (Sweden)

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.

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

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

2015-05-01

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

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.

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

Generalization and extrapolation of treatment effects from clinical studies in rheumatoid arthritis

NARCIS (Netherlands)

Nair, S.C.; Kievit, W.; Janse, R.W.; Bijlsma, J.W.J.; Fransen, J.; Lafeber, F.P.J.G.; Welsing, P.M.J.

2014-01-01

OBJECTIVE: Pragmatic clinical trials have been proposed as a solution for nongeneralizability of randomized clinical trial (RCT) results. We investigated whether treatment effects of pragmatic clinical trials are indeed generalizable to clinical practice and how efficacy estimates from published

Effectiveness of strategies for recruiting overweight and obese Generation Y women to a clinical weight management trial.

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Griffin, Hayley J; O'Connor, Helen T; Rooney, Kieron B; Steinbeck, Katharine S

2013-01-01

Limited research in young overweight and obese women indicates that they are difficult to recruit to weight management trials, with attrition higher and weight loss success lower than middle to older age participants. This study aimed to evaluate the effectiveness of different recruitment strategies for a clinical weight loss trial in overweight and obese Generation Y women. Overweight and obese (BMI >=27.5 kg/m-2) women aged 18-25 years (n=70) were required for a 12 month clinical weight management trial including diet, exercise and behaviour modification. Contact with researchers and eventual recruitment are reported for the various strategies employed to engage participants. Data reported as % or mean±SE. Recruitment was challenging with only 50 of the total 70 participants recruited within the scheduled time frame (24 months). Just over one quarter (27%) of volunteers assessed were recruited. Flyers posted around local tertiary education campuses were the most successful method, yielding 36% of included participants. This was followed by advertisements on the local area health service intranet (26%) and in local and metropolitan newspapers (16%). Recruitment of overweight and obese Generation Y women for a clinical weight loss trial was difficult. Multiple strategies targeted at this age and gender group were required. Less rigorous selection criteria and reduced face-to-face intervention time may improve recruitment and retention rates into clinical trials for this age group.

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

Confidence Intervals for Effect Sizes: Compliance and Clinical Significance in the "Journal of Consulting and Clinical Psychology"

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Odgaard, Eric C.; Fowler, Robert L.

2010-01-01

Objective: In 2005, the "Journal of Consulting and Clinical Psychology" ("JCCP") became the first American Psychological Association (APA) journal to require statistical measures of clinical significance, plus effect sizes (ESs) and associated confidence intervals (CIs), for primary outcomes (La Greca, 2005). As this represents the single largest…

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.)

Pneumococcal and influenza vaccination status of hospitalized adults with community acquired pneumonia and the effects of vaccination on clinical presentation.

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Demirdogen Cetinoglu, Ezgi; Uzaslan, Esra; Sayıner, Abdullah; Cilli, Aykut; Kılınc, Oguz; Sakar Coskun, Aysın; Hazar, Armağan; Kokturk, Nurdan; Filiz, Ayten; Polatli, Mehmet

2017-09-02

Previous reports have shown that vaccination rates of adult at-risk populations are low in Turkey. There are differing reports with regards to the effectiveness of the influenza and the pneumococcal polysaccharide vaccine (PPSV23) on the clinical outcomes of community acquired pneumonia (CAP). The purpose of this study was to analyze the influenza (FV) and pneumococcal vaccination (PV) status, the factors that influence the receipt of influenza/pneumococcal vaccine and the effects of prior vaccination on the clinical outcomes in adults hospitalized with CAP. Patients hospitalized with CAP between March 2009 and October 2013 and registered at the web-based Turkish Thoracic Society Pneumonia Database (TURCAP) were included in this multicentric, observational study. Of a total of 787 cases, data were analyzed for 466 patients for whom self-reported information on PV and FV was available. In this adult population with CAP, the vaccination rate with both the pneumococcal and influenza vaccines was found to be 6%. Prior FV was found to be the sole variable that was associated with the receipt of PV [OR 17.8, 95% CI (25-75:8.56-37.01), p pneumonia severity index (PSI) score ≥ 90, CURB-65 score ≥3 and multilobar involvement, but not the vaccination status, were identified as independent determinants of ICU admission. This study showed that, among patients hospitalized with CAP, the FV and/or PV rates are low. Prior vaccination does not appear to significantly affect the clinical outcomes.

Cost-effectiveness analysis of microdose clinical trials in drug development.

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Yamane, Naoe; Igarashi, Ataru; Kusama, Makiko; Maeda, Kazuya; Ikeda, Toshihiko; Sugiyama, Yuichi

2013-01-01

Microdose (MD) clinical trials have been introduced to obtain human pharmacokinetic data early in drug development. Here we assessed the cost-effectiveness of microdose integrated drug development in a hypothetical model, as there was no such quantitative research that weighed the additional effectiveness against the additional time and/or cost. First, we calculated the cost and effectiveness (i.e., success rate) of 3 types of MD integrated drug development strategies: liquid chromatography-tandem mass spectrometry, accelerator mass spectrometry, and positron emission tomography. Then, we analyzed the cost-effectiveness of 9 hypothetical scenarios where 100 drug candidates entering into a non-clinical toxicity study were selected by different methods as the conventional scenario without MD. In the base-case, where 70 drug candidates were selected without MD and 30 selected evenly by one of the three MD methods, incremental cost-effectiveness ratio per one additional drug approved was JPY 12.7 billion (US$ 0.159 billion), whereas the average cost-effectiveness ratio of the conventional strategy was JPY 24.4 billion, which we set as a threshold. Integrating MD in the conventional drug development was cost-effective in this model. This quantitative analytical model which allows various modifications according to each company's conditions, would be helpful for guiding decisions early in clinical development.

Clinically Effective Treatment of Fibromyalgia Pain With High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization.

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Castillo-Saavedra, Laura; Gebodh, Nigel; Bikson, Marom; Diaz-Cruz, Camilo; Brandao, Rivail; Coutinho, Livia; Truong, Dennis; Datta, Abhishek; Shani-Hershkovich, Revital; Weiss, Michal; Laufer, Ilan; Reches, Amit; Peremen, Ziv; Geva, Amir; Parra, Lucas C; Fregni, Felipe

2016-01-01

Despite promising preliminary results in treating fibromyalgia (FM) pain, no neuromodulation technique has been adopted in clinical practice because of limited efficacy, low response rate, or poor tolerability. This phase II open-label trial aims to define a methodology for a clinically effective treatment of pain in FM by establishing treatment protocols and screening procedures to maximize efficacy and response rate. High-definition transcranial direct current stimulation (HD-tDCS) provides targeted subthreshold brain stimulation, combining tolerability with specificity. We aimed to establish the number of HD-tDCS sessions required to achieve a 50% FM pain reduction, and to characterize the biometrics of the response, including brain network activation pain scores of contact heat-evoked potentials. We report a clinically significant benefit of a 50% pain reduction in half (n = 7) of the patients (N = 14), with responders and nonresponders alike benefiting from a cumulative effect of treatment, reflected in significant pain reduction (P = .035) as well as improved quality of life (P = .001) over time. We also report an aggregate 6-week response rate of 50% of patients and estimate 15 as the median number of HD-tDCS sessions to reach clinically meaningful outcomes. The methodology for a pivotal FM neuromodulation clinical trial with individualized treatment is thus supported. Registered in Clinicaltrials.gov under registry number NCT01842009. In this article, an optimized protocol for the treatment of fibromyalgia pain with targeted subthreshold brain stimulation using high-definition transcranial direct current stimulation is outlined. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

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

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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.

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.

Effect of home testing of international normalized ratio on clinical events.

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Matchar, David B; Jacobson, Alan; Dolor, Rowena; Edson, Robert; Uyeda, Lauren; Phibbs, Ciaran S; Vertrees, Julia E; Shih, Mei-Chiung; Holodniy, Mark; Lavori, Philip

2010-10-21

Warfarin anticoagulation reduces thromboembolic complications in patients with atrial fibrillation or mechanical heart valves, but effective management is complex, and the international normalized ratio (INR) is often outside the target range. As compared with venous plasma testing, point-of-care INR measuring devices allow greater testing frequency and patient involvement and may improve clinical outcomes. We randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic. The primary end point was the time to a first major event (stroke, major bleeding episode, or death). The patients were followed for 2.0 to 4.75 years, for a total of 8730 patient-years of follow-up. The time to the first primary event was not significantly longer in the self-testing group than in the clinic-testing group (hazard ratio, 0.88; 95% confidence interval, 0.75 to 1.04; P=0.14). The two groups had similar rates of clinical outcomes except that the self-testing group reported more minor bleeding episodes. Over the entire follow-up period, the self-testing group had a small but significant improvement in the percentage of time during which the INR was within the target range (absolute difference between groups, 3.8 percentage points; P<0.001). At 2 years of follow-up, the self-testing group also had a small but significant improvement in patient satisfaction with anticoagulation therapy (P=0.002) and quality of life (P<0.001). As compared with monthly high-quality clinic testing, weekly self-testing did not delay the time to a first stroke, major bleeding episode, or death to the extent suggested by prior studies. These results do not support the superiority of self-testing over clinic testing in reducing the risk of stroke, major bleeding episode, and death among patients taking warfarin

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

Validation of the Marijuana Effect Expectancies Questionnaire (MEEQ in a Non-Clinical French-Speaking Adolescent Sample

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Emilie Schmits

2016-02-01

Full Text Available Teenagers commonly use cannabis. Expectancies related to the effects of cannabis play an important role in its consumption and are frequently measured with the Marijuana Effect Expectancies Questionnaire (MEEQ. This study aims to assess the psychometric properties (factor structure, internal consistency reliability, criterion validity of the French MEEQ. A sample of 1,343 non-clinical teenagers (14–18 years were recruited to answer a self-report questionnaire; 877 of them responded twice (one-year interval. A four-factor structure was obtained: Cognitive Impairment and Negative, Relaxation and Social Facilitation, Perceptual Enhancement and Craving and Negative Behavioral Effect Expectancies. It is concluded that the French MEEQ constitutes an appropriate tool to measure cannabis effect expectancies among adolescents.

Effectiveness of faculty training to enhance clinical evaluation of student competence in ethical reasoning and professionalism.

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Christie, Carole; Bowen, Denise; Paarmann, Carlene

2007-08-01

This study evaluated the short- and long-term effectiveness of faculty training to enhance clinical evaluation of ethical reasoning and professionalism in a baccalaureate dental hygiene program. Ethics, values, and professionalism are best measured in contexts comparable to practice; therefore, authentic evaluation is desirable for assessing these areas of competence. Methods were the following: 1) a faculty development workshop implementing a core values-based clinical evaluation system for assessing students' professional judgment; 2) subsequent evaluation of the clinical faculty's use of core values for grading and providing written comments related to students' professional judgment during patient care for three academic years; and 3) evaluation of program outcomes assessments regarding clinical learning experiences related to ethics and professionalism domains. Results revealed the clinical faculty's evaluation of professional judgment during patient care was enhanced by training; written comments more frequently related to core values defined in the American Dental Hygienists' Association (ADHA) Code of Ethics; and faculty members reported more confidence and comfort evaluating professional judgment after implementation of this evaluation system and receiving training in its application. Students were more positive in outcomes assessments about their competency and learning experiences related to professionalism and ethics. This article shares one approach for enhancing clinical faculty's authentic evaluation of student competence in ethical reasoning and professionalism.

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

CLINICAL OUTCOMES AND SELF-REPORTED SYMPTOMS IN PATIENTS WITH ACROMEGALY: AN 8-YEAR FOLLOW-UP OF A LANREOTIDE STUDY.

Science.gov (United States)

Khairi, Shafaq; Sagvand, Babak Torabi; Pulaski-Liebert, Karen J; Tritos, Nicholas A; Klibanski, Anne; Nachtigall, Lisa B

2017-01-01

The aim of this study was to evaluate the proportion of patients with acromegaly who remained on long-term lanreotide depot after completion of an open-label multicenter phase III clinical trial (SALSA: A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel), compare baseline and long-term follow-up symptoms scores, and correlate scores with individual longitudinal clinical outcomes. Records of all subjects previously enrolled at the Massachusetts General Hospital site of SALSA were reviewed. Those who remained on lanreotide were interviewed and asked to complete a questionnaire that they had filled out in SALSA in 2007 regarding their current symptomatology and injection side effects, as well as to complete the Acromegaly Quality of Life Questionnaire. Furthermore, clinical, biochemical, and radiographic data related to acromegaly and its comorbidities were tracked throughout follow-up. Six out of 7 patients chose to remain on lanreotide, and 5 of them continued lanreotide depot through last follow-up, for up to 8 years or in 1 case until death. In all cases, lanreotide remained well tolerated, and insulin-like growth factor-1 levels and pituitary imaging remained well controlled on stable doses. While comorbidities persisted or developed, the self-reported symptom score after up to 8 years of therapy showed a significant decrease in frequency or resolution in symptoms that were reported at baseline. This study shows a significant decrease in frequency or resolution in self-reported symptoms in well-controlled patients receiving long-term lanreotide therapy. AcroQoL = Acromegaly Quality of Life Questionnaire GH = growth hormone GI = gastrointestinal IGF-1 = insulin-like growth factor-1 SALSA = A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel.

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...

Clinical utility of progesterone receptor modulators and their effect on the endometrium.

Science.gov (United States)

Spitz, Irving M

2009-08-01

In view of the spate of recent publications related to mifepristone and some second generation progesterone receptor modulators (PRMs), this appears to be an opportune time to view the clinical status of these compounds. Randomized double-blind placebo-controlled trials have been conducted with mifepristone, CDB-4124 (Proellex), CDB-2914 (VA 2914, Ulipristal) and asoprisnil (J867). All these PRMs are effective in the treatment of uterine fibroids where they are associated with a reduction in pain, bleeding and improvement in quality of life and decrease in fibroid size. CDB-4124 is also efficacious in endometriosis. Long-term treatment with PRMs may be associated with endometrial thickening on ultrasound and there have been reports of endometrial hyperplasia. Several reassuring recent publications have done much to explain the mechanism underlying these endometrial changes. The most common histological finding is cystic glandular dilatation often associated with both admixed estrogen (mitotic) and progestin (secretory) epithelial effects. This histology has not been previously encountered in clinical practice and should not be confused with endometrial hyperplasia. The endometrial thickness is related to this cystic glandular dilatation. At this stage of development, PRMs cannot be administered for longer than 3 or 4 months. Even over this time, there is improvement of symptoms associated with fibroids and endometriosis. Clinicians and pathologists need to be aware that the endometrial thickening and histological appearance do not represent endometrial hyperplasia.

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.

Prosthetists' perceptions and use of outcome measures in clinical practice: Long-term effects of focused continuing education.

Science.gov (United States)

Hafner, Brian J; Spaulding, Susan E; Salem, Rana; Morgan, Sara J; Gaunaurd, Ignacio; Gailey, Robert

2017-06-01

Continuing education is intended to facilitate clinicians' skills and knowledge in areas of practice, such as administration and interpretation of outcome measures. To evaluate the long-term effect of continuing education on prosthetists' confidence in administering outcome measures and their perceptions of outcomes measurement in clinical practice. Pretest-posttest survey methods. A total of 66 prosthetists were surveyed before, immediately after, and 2 years after outcomes measurement education and training. Prosthetists were grouped as routine or non-routine outcome measures users, based on experience reported prior to training. On average, prosthetists were just as confident administering measures 1-2 years after continuing education as they were immediately after continuing education. In all, 20% of prosthetists, initially classified as non-routine users, were subsequently classified as routine users at follow-up. Routine and non-routine users' opinions differed on whether outcome measures contributed to efficient patient evaluations (79.3% and 32.4%, respectively). Both routine and non-routine users reported challenges integrating outcome measures into normal clinical routines (20.7% and 45.9%, respectively). Continuing education had a long-term impact on prosthetists' confidence in administering outcome measures and may influence their clinical practices. However, remaining barriers to using standardized measures need to be addressed to keep practitioners current with evolving practice expectations. Clinical relevance Continuing education (CE) had a significant long-term impact on prosthetists' confidence in administering outcome measures and influenced their clinical practices. In all, approximately 20% of prosthetists, who previously were non-routine outcome measure users, became routine users after CE. There remains a need to develop strategies to integrate outcome measurement into routine clinical practice.

A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function.

Science.gov (United States)

Jovancevic, Jelena; Rosano, Caterina; Perera, Subashan; Erickson, Kirk I; Studenski, Stephanie

2012-06-06

Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span.The study is IRB approved and the number is: PRO08080012ClinicalTrials.gov Identifier: NCT01443455.

Clinical benefit, complication patterns and cost effectiveness of laser in situ keratomileusis (LASIK) in moderate myopia: results of independent meta analyses on clinical outcome and postoperative complication profiles.

Science.gov (United States)

Lamparter, J; Dick, H B; Krummenauer, Frank

2005-09-12

Laser in situ keratomileusis (LASIK) means a patient investment of 2426 Euro per eye, which usually cannot be funded by European health care insurers. In the context of recent resource allocation discussions, however, the cost effectiveness of LASIK could become an important indication of allocation decisions. Therefore an evidence based estimation of its incremental cost effectiveness was intended. Three independent meta analyses were implemented to estimate the refractive gain (dpt) due to conventional LASIK procedures as well as the predictability of the latter (%) (fraction of eyes achieving a postoperative refraction with maximum deviation of +/- 0.5 dpt from the target refraction). Study reports of 1995 - 2004 (English or German language) were screened for appropriate key words. Meta effects in refractive gain and predictability were estimated by means and standard deviations of reported effect measures. Cost data were estimated by German DRG rates and individual clinical pathway calculations; cost effectiveness was then computed in terms of the incremental cost effectiveness ratio (ICER) for both clinical benefit endpoints. A sensitivity analysis comprised cost variations of +/- 10 % and utility variations alongside the meta effects' 95% confidence intervals. Total direct costs from the patients' perspective were estimated at 2426 Euro per eye, associated with a refractive meta benefit of 5.93 dpt (95% meta confidence interval 5.32 - 6.54 dpt) and a meta predictability of 67% (43% - 91%). In terms of incremental costs, the unilateral LASIK implied a patient investion of 409 Euro (sensitivity range 351 - 473 Euro) per gained refractive unit or 36 Euro (27 - 56 Euro) per gained percentage point in predictability. When LASIK associated complication patterns were considered, the total direct costs amounted up to 3075 Euro, resulting in incremental costs of 519 Euro / dpt (sensitivity range 445 - 600 Euro / dpt) or 46 Euro / % (34 - 72 Euro / %). Most frequently

Clinical effect of intravenous thrombolysis combined with nicorandil ...

African Journals Online (AJOL)

Tropical Journal of Pharmaceutical Research June 2016; 15 (6): 1335-1339. ISSN: 1596-5996 ... Original Research Article. Clinical effect of ... pain and arrhythmia; but the most representative .... people who are given placebo, confirming the.

Self-reported impulsivity, but not behavioral choice or response impulsivity, partially mediates the effect of stress on drinking behavior.

Science.gov (United States)

Hamilton, Kristen R; Ansell, Emily B; Reynolds, Brady; Potenza, Marc N; Sinha, Rajita

2013-01-01

Stress and impulsivity contribute to alcohol use, and stress may also act via impulsivity to increase drinking behavior. Impulsivity represents a multi-faceted construct and self-report and behavioral assessments may effectively capture distinct clinically relevant factors. The present research investigated whether aspects of impulsivity mediate the effect of stress on alcohol use. A community-based sample of 192 men and women was assessed on measures of cumulative stress, alcohol use, self-reported impulsivity, and behavioral choice and response impulsivity. Data were analyzed using regression and bootstrapping techniques to estimate indirect effects of stress on drinking via impulsivity. Cumulative adversity exhibited both direct effects and indirect effects (via self-reported impulsivity) on drinking behavior. Additional models examining specific types of stress indicated direct and indirect effects of trauma and recent life events, and indirect effects of major life events and chronic stressors on drinking behavior. Overall, cumulative stress was associated with increased drinking behavior, and this effect was partially mediated by self-reported impulsivity. Self-reported impulsivity also mediated the effects of different types of stress on drinking behavior. These findings highlight the value of mediation models to examine the pathways through which different types of stress increase drinking behavior. Treatment and prevention strategies should focus on enhancing stress management and self-control.