Discordance between 'actual' and 'scheduled' check-in times at a heart failure clinic.

PubMed

Gorodeski, Eiran Z; Joyce, Emer; Gandesbery, Benjamin T; Blackstone, Eugene H; Taylor, David O; Tang, W H Wilson; Starling, Randall C; Hachamovitch, Rory

2017-01-01

A 2015 Institute Of Medicine statement "Transforming Health Care Scheduling and Access: Getting to Now", has increased concerns regarding patient wait times. Although waiting times have been widely studied, little attention has been paid to the role of patient arrival times as a component of this phenomenon. To this end, we investigated patterns of patient arrival at scheduled ambulatory heart failure (HF) clinic appointments and studied its predictors. We hypothesized that patients are more likely to arrive later than scheduled, with progressively later arrivals later in the day. Using a business intelligence database we identified 6,194 unique patients that visited the Cleveland Clinic Main Campus HF clinic between January, 2015 and January, 2017. This clinic served both as a tertiary referral center and a community HF clinic. Transplant and left ventricular assist device (LVAD) visits were excluded. Punctuality was defined as the difference between 'actual' and 'scheduled' check-in times, whereby negative values (i.e., early punctuality) were patients who checked-in early. Contrary to our hypothesis, we found that patients checked-in late only a minority of the time (38% of visits). Additionally, examining punctuality by appointment hour slot we found that patients scheduled after 8AM had progressively earlier check-in times as the day progressed (P < .001 for trend). In both a Random Forest-Regression framework and linear regression models the most important risk-adjusted predictors of early punctuality were: later in the day appointment hour slot, patient having previously been to the hospital, age in the early 70s, and white race. Patients attending a mixed population ambulatory HF clinic check-in earlier than scheduled times, with progressive discrepant intervals throughout the day. This finding may have significant implications for provider utilization and resource planning in order to maximize clinic efficiency. The impact of elective early arrival on

The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications.

PubMed

Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

2014-10-01

To assess the proportion of clinical trials explicitly reporting the risk of unblinding, to evaluate the completeness of reporting on unblinding risk, and to describe the reported procedures involved in assessing unblinding. We sampled at random 300 blinded randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. 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 for unblinding was perceptible physical properties of the treatments, for example, a difference in the taste and odor of a typhoid vaccine compared with its placebo. Published articles on randomized clinical trials infrequently reported risk of unblinding. This may reflect a tendency for avoiding reporting actual or suspected unblinding or a genuine low risk of unblinding. Copyright © 2014 Elsevier Inc. All rights reserved.

Motivators to participation in actual HIV vaccine trials.

PubMed

Dhalla, Shayesta; Poole, Gary

2014-02-01

An examination of actual HIV vaccine trials can contribute to an understanding of motivators for participation in these studies. Analysis of these motivators reveals that they can be categorized as social and personal benefits. Social benefits are generally altruistic, whereas personal benefits are psychological, physical, and financial. In this systematic review, the authors performed a literature search for actual preventive HIV vaccine trials reporting motivators to participation. Of studies conducted in the Organization for Economic Co-operation and Development (OECD) countries, the authors retrieved 12 studies reporting on social benefits and seven reporting on personal benefits. From the non-OECD countries, nine studies reported on social benefits and eight studies on personal benefits. Social benefits were most frequently described on macroscopic, altruistic levels. Personal benefits were most frequently psychological in nature. Rates of participation were compared between the OECD and the non-OECD countries. Knowledge of actual motivators in specific countries and regions can help target recruitment in various types of actual HIV vaccine trials.

How do clinicians actually use the Diagnostic and Statistical Manual of Mental Disorders in clinical practice and why we need to know more.

PubMed

First, Michael B; Bhat, Venkat; Adler, David; Dixon, Lisa; Goldman, Beth; Koh, Steve; Levine, Bruce; Oslin, David; Siris, Sam

2014-12-01

The clinical use of the Diagnostic and Statistical Manual of Mental Disorders (DSM) is explicitly stated as a goal for both the DSM Fourth Edition and DSM Fifth Edition (DSM-5) revisions. Many uses assume a relatively faithful application of the DSM diagnostic definitions. However, studies demonstrate significant discrepancies between clinical psychiatric diagnoses with those made using structured interviews suggesting that clinicians do not systematically apply the diagnostic criteria. The limited information regarding how clinicians actually use the DSM raises important questions: a) How can the clinical use be improved without first having a baseline assessment? b) How can potentially significant shifts in practice patterns based on wording changes be assessed without knowing the extent to which the criteria are used as written? Given the American Psychiatric Association's plans for interim revisions to the DSM-5, the value of a detailed exploration of its actual use in clinical practice remains a significant ongoing concern and deserves further study including a number of survey and in vivo studies.

Dangers of "confirmatory" cancer trials that fail to actually test the original hypothesis.

PubMed

Markman, Maurie

2014-04-01

The concept of "confirmatory" studies is a standard and important component of the overall clinical trials strategy in oncology. However, it is critical that such studies are similar enough in basic design and how they are conducted that they actually have the realistic potential to confirm, or refute, objectively the findings of the original study. In this commentary, two examples of clinical studies in the gynecologic oncology arena suggested by some to serve as "confirmatory" trials for the original reports demonstrate both the dangers and potential inappropriateness of such conclusions.

Why mistreatment of medical students is not reported in clinical settings: perspectives of trainees.

PubMed

Ahmadipour, Habibeh; Vafadar, Reza

2016-01-01

Mistreatment of medical students is a major source of stress for them. Studies indicate a high incidence of such mistreatment, especially in clinical settings. In most cases, students who have been mistreated do not report it to the authorities. This study investigated factors related to the failure to report mistreatment. This was a cross-sectional study carried out in Kerman Medical School, Iran. All students in the internship and clerkship stages, as well as residents, were selected through the census method. Experiences of mistreatment and the reasons for not reporting them were evaluated using a questionnaire. The data were analysed with SPSS 19. Ninety-three per cent of the participants experienced mistreatment, but less than half of them reported it. Residents and interns reported emotional and academic mistreatment, respectively, more than other groups. The most common reason for not reporting mistreatment was that the students did not think reporting would accomplish anything. Our study showed that the experience of mistreatment in the clinical setting is common, but the cases reported to the authorities are far fewer than the actual number of cases. Educational systems should make extensive efforts to detect and prevent mistreatment to improve the teaching-learning environment.

Hypochondria as an actual neurosis.

PubMed

Nissen, Bernd

2017-09-27

Freud defined hypochondria as an actual neurosis. In this paper the actual neurosis will be interpreted as unbound traumatic elements which threaten the self. In severe hypochondria, breakdowns have occurred, as outlined by Winnicott. The nameless traumatic elements of the breakdown have been encapsulated. The moment these encapsulated elements are liberated, an actual dynamic takes place which threatens the self with annihilation. Projective identification is not possible because no idea of containment exists. The self tries to evacuate these elements projectively, thus triggering a disintegrative regression. However, the object of this projection, which becomes a malign introject, is felt to remove the remaining psychical elements, forcing the worthless residue back into the self. In a final re-introjection, the self is threatened by unintegration. To save the self, these elements are displaced into an organ which becomes hypochondriacal, an autistoid object, protecting itself against unintegration and decomposition. An autistoid dynamic develops between the hypochondriac organ, the ego and the introject. Two short clinical vignettes illustrate the regressive dynamical and metapsychological considerations. Copyright © 2017 Institute of Psychoanalysis.

SELF-ACTUALIZATION AND THE UTILIZATION OF TALENT.

ERIC Educational Resources Information Center

FRENCH, JOHN R.P.; MILLER, DANIEL R.

THIS STUDY ATTEMPTED (1) TO DEVELOP A THEORY OF THE CAUSES AND CONSEQUENCES OF SELF-ACTUALIZATION AS RELATED TO THE UTILIZATION OF TALENT, (2) TO FIT THE THEORY TO EXISTING DATA, AND (3) TO PLAN ONE OR MORE RESEARCH PROJECTS TO TEST THE THEORY. TWO ARTICLES ON IDENTITY AND MOTIVATION AND SELF-ACTUALIZATION AND SELF-IDENTITY THEORY REPORTED THE…

Can Teachers' Self-Reported Efficacy, Concerns, and Attitudes toward Inclusion Scores Predict Their Actual Inclusive Classroom Practices?

ERIC Educational Resources Information Center

Sharma, Umesh; Sokal, Laura

2016-01-01

This research was undertaken to determine if significant relationships exist between teachers' self-reported attitudes, concerns, and efficacy to teach in inclusive classrooms and their actual classroom behaviour in Winnipeg, Canada. Five teachers completed 3 scales measuring their attitudes to inclusion, their level of concerns about teaching in…

How do gender and anxiety affect students' self-assessment and actual performance on a high-stakes clinical skills examination?

PubMed

Colbert-Getz, Jorie M; Fleishman, Carol; Jung, Julianna; Shilkofski, Nicole

2013-01-01

Research suggests that medical students are not accurate in self-assessment, but it is not clear whether students over- or underestimate their skills or how certain characteristics correlate with accuracy in self-assessment. The goal of this study was to determine the effect of gender and anxiety on accuracy of students' self-assessment and on actual performance in the context of a high-stakes assessment. Prior to their fourth year of medical school, two classes of medical students at Johns Hopkins University School of Medicine completed a required clinical skills exam in fall 2010 and 2011, respectively. Two hundred two students rated their anxiety in anticipation of the exam and predicted their overall scores in the history taking and physical examination performance domains. A self-assessment deviation score was calculated by subtracting each student's predicted score from his or her score as rated by standardized patients. When students self-assessed their data gathering performance, there was a weak negative correlation between their predicted scores and their actual scores on the examination. Additionally, there was an interaction effect of anxiety and gender on both self-assessment deviation scores and actual performance. Specifically, females with high anxiety were more accurate in self-assessment and achieved higher actual scores compared with males with high anxiety. No differences by gender emerged for students with moderate or low anxiety. Educators should take into account not only gender but also the role of emotion, in this case anxiety, when planning interventions to help improve accuracy of students' self-assessment.

Actual versus perceived peer sexual risk behavior in online youth social networks.

PubMed

Black, Sandra R; Schmiege, Sarah; Bull, Sheana

2013-09-01

Perception of peer behaviors is an important predictor of actual risk behaviors among youth. However, we lack understanding of peer influence through social media and of actual and perceived peer behavior concordance. The purpose of this research is to document the relationship between individual perception of and actual peer sexual risk behavior using online social networks. The data are a result of a secondary analysis of baseline self-reported and peer-reported sexual risk behavior from a cluster randomized trial including 1,029 persons from 162 virtual networks. Individuals (seeds) recruited up to three friends who then recruited additional friends, extending three waves from the seed. ANOVA models compared network means of actual participant behavior across categories of perceived behavior. Concordance varied between reported and perceived behavior, with higher concordance between perceived and reported condom use, multiple partners, concurrent partners, sexual pressure, and drug and alcohol use during sex. Individuals significantly over-reported risk and under-reported protective peer behaviors related to sex.

Why prudence is needed when interpreting articles reporting clinical trial results in mental health.

PubMed

Dal-Ré, Rafael; Bobes, Julio; Cuijpers, Pim

2017-03-28

Clinical trial results' reliability is impacted by reporting bias. This is primarily manifested as publication bias and outcome reporting bias. Mental health trials are prone to two methodological deficiencies: (1) using small numbers of participants that facilitates false positive findings and exaggerated size effects, and (2) the obligatory use of psychometric scales that require subjective assessments. These two deficiencies contribute to the publication of unreliable results. Considerable reporting bias has been found in safety and efficacy findings in psychotherapy and pharmacotherapy trials. Reporting bias can be carried forward to meta-analyses, a key source for clinical practice guidelines. The final result is the frequent overestimation of treatment effects that could impact patients and clinician-informed decisions. Prospective registration of trials and publication of results are the two major methods to reduce reporting bias. Prospective trial registration will allow checking whether they are published (so it will help to prevent publication bias) and, if published, whether those outcomes and analyses that were deemed as appropriate before trial commencement are actually published (hence helping to find out selective reporting of outcomes). Unfortunately, the rate of registered trials in mental health interventions is low and, frequently, of poor quality. Clinicians should be prudent when interpreting the results of published trials and some meta-analyses - such as those conducted by scientists working for the sponsor company or those that only include published trials. Prescribers, however, should be confident when prescribing drugs following the summary of product characteristics, since regulatory agencies have access to all clinical trial results.

42 CFR 405.2470 - Reports and maintenance of records.

Code of Federal Regulations, 2013 CFR

2013-10-01

... initial reporting period, the clinic or center must submit an estimate of budgeted costs and visits for..., including the allowable costs actually incurred for the period and the actual number of visits for rural... estimated costs and visits for rural health clinic services or Federally qualified health center services...

42 CFR 405.2470 - Reports and maintenance of records.

Code of Federal Regulations, 2011 CFR

2011-10-01

... initial reporting period, the clinic or center must submit an estimate of budgeted costs and visits for..., including the allowable costs actually incurred for the period and the actual number of visits for rural... estimated costs and visits for rural health clinic services or Federally qualified health center services...

42 CFR 405.2470 - Reports and maintenance of records.

Code of Federal Regulations, 2012 CFR

2012-10-01

... initial reporting period, the clinic or center must submit an estimate of budgeted costs and visits for..., including the allowable costs actually incurred for the period and the actual number of visits for rural... estimated costs and visits for rural health clinic services or Federally qualified health center services...

Comparison of Pharmacy Students’ Perceived and Actual Knowledge Using the Pharmacy Curricular Outcomes Assessment

PubMed Central

Friesner, Daniel L.

2012-01-01

Objective. To determine whether a correlation exists between third-year PharmD students’ perceived pharmacy knowledge and actual pharmacy knowledge as assessed by the Pharmacy Curricular Outcomes Assessment (PCOA). Methods. In 2010 and 2011, the PCOA was administered in a low-stakes environment to third-year pharmacy students at North Dakota State University College of Pharmacy, Nursing, and Allied Sciences (COPNAS). A survey instrument was also administered on which students self-assessed their perceived competencies in each of the core areas covered by the PCOA examination. Results. The pharmacy students rated their competencies slightly higher than average. Performance on the PCOA was similar to but slightly higher than national averages. Correlations between each of the 4 content areas (basic biomedical sciences, pharmaceutical sciences, social/administrative sciences, and clinical sciences) mirrored those reported nationally by the National Association of Boards of Pharmacy (NABP). Student performance on the basic biomedical sciences portion of the PCOA was significantly correlated with students’ perceived competencies in the biomedical sciences. No other correlations between actual and perceived competencies were significant. Conclusion. A lack of correlation exists between what students perceive they know and what they actually know in the areas of pharmaceutical science; social, behavioral, and administrative science; and clinical science. Therefore, additional standardized measures are needed to assess curricular effectiveness and provide comparisons among pharmacy programs. PMID:22611272

Comparison of pharmacy students' perceived and actual knowledge using the Pharmacy Curricular Outcomes Assessment.

PubMed

Naughton, Cynthia A; Friesner, Daniel L

2012-05-10

To determine whether a correlation exists between third-year PharmD students' perceived pharmacy knowledge and actual pharmacy knowledge as assessed by the Pharmacy Curricular Outcomes Assessment (PCOA). In 2010 and 2011, the PCOA was administered in a low-stakes environment to third-year pharmacy students at North Dakota State University College of Pharmacy, Nursing, and Allied Sciences (COPNAS). A survey instrument was also administered on which students self-assessed their perceived competencies in each of the core areas covered by the PCOA examination. The pharmacy students rated their competencies slightly higher than average. Performance on the PCOA was similar to but slightly higher than national averages. Correlations between each of the 4 content areas (basic biomedical sciences, pharmaceutical sciences, social/administrative sciences, and clinical sciences) mirrored those reported nationally by the National Association of Boards of Pharmacy (NABP). Student performance on the basic biomedical sciences portion of the PCOA was significantly correlated with students' perceived competencies in the biomedical sciences. No other correlations between actual and perceived competencies were significant. A lack of correlation exists between what students perceive they know and what they actually know in the areas of pharmaceutical science; social, behavioral, and administrative science; and clinical science. Therefore, additional standardized measures are needed to assess curricular effectiveness and provide comparisons among pharmacy programs.

Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

PubMed

Riley, Isaretta L; Boulware, L Ebony; Sun, Jie-Lena; Chiswell, Karen; Que, Loretta G; Kraft, Monica; Todd, Jamie L; Palmer, Scott M; Anderson, Monique L

2018-02-01

Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0

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.

PubMed

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

Facebook as a Library Tool: Perceived vs. Actual Use

ERIC Educational Resources Information Center

Jacobson, Terra B.

2011-01-01

As Facebook has come to dominate the social networking site arena, more libraries have created their own library pages on Facebook to create library awareness and to function as a marketing tool. This paper examines reported versus actual use of Facebook in libraries to identify discrepancies between intended goals and actual use. The results of a…

Student Exposure to Actual Patients in the Classroom.

ERIC Educational Resources Information Center

Chisholm, Marie A.; McCall, Charles Y.; Francisco, George E., Jr.; Poirier, Sylvie

1997-01-01

Two clinical courses for first-year dental students were designed to develop students' interaction skills through actual patient case presentations and discussions and an interdisciplinary teaching approach. Results indicate students preferred the case presentations, with or without lecture, to the lecture-only approach and felt they learned more…

Interpersonal Communication Behaviors and Self-Actualizing Values: A Conceptual Framework.

ERIC Educational Resources Information Center

Macklin, Thomas

This report addresses the relationship between self-actualizing values and interpersonal communication behaviors. After a discussion of behavioristic and humanistic frameworks for social science research, the paper explains Abraham Maslow's and Carl Roger's concepts of self-actualization as the tendency toward completing and perfecting one's…

[Botulism--actual epidemiologic and clinical problem].

PubMed

Moniuszko, Anna; Czupryna, Piotr; Pancewicz, Sławomir Andrzej; Kondrusik, Maciej; Grygorczuk, Sambor; Zajkowska, Joanna Maria

2009-07-01

Botulism incidence in Poland is the highest in whole European Union. Polish emigrants suffer from botulism as well. This phenomenon is supposed to be caused by Polish custom of preparing home-made food. The most frequent clinical forms of botulism are: foodborne botulism, wound botulism and infant botulism. The diagnosis is mostly made on case history, physical examination and it is confirmed by toxin detection in food remains, vomits and stool. In treatment of adult's botulism antitoxin derived from hyperimmunizated horses, but in infant botulism human immunoglobulin should be used.

Annual Statistical Report of the Public Schools of Arkansas, Public Charter Schools, and Education Service Cooperatives, 2013-2014 Actual and 2014-2015 Budgeted, (ASR)

ERIC Educational Resources Information Center

Arkansas Department of Education, 2015

2015-01-01

In compliance with the provisions of A.C.A.§§6-20-2201 et seq., the Annual Statistical Report of the Public Schools of Arkansas, Public Charter Schools, and Education Service Cooperatives, 2013-2014 Actual and 2014-2015 Budgeted, (ASR) is presented here. The Rankings of Selected Items of the Public Schools of Arkansas, 2013-2014 Actual, (Rankings)…

Effects of Nurses' Perceptions of Actual and Demanded Competence on Turnover Intentions.

PubMed

Takase, Miyuki; Yamamoto, Masako; Sato, Yoko; Imai, Takiko; Kawamoto, Mitsuko

2017-10-01

With the growing focus on continuous professional development, demands placed on nurses to uphold nursing competence have been increasing. This study examined how nurses with different lengths of clinical experience perceived the relationship between their actual competence and the competence they felt was demanded of them, and how this relationship was related to their turnover intentions. Survey questionnaires were distributed to 1,377 nurses, of whom 765 returned usable completed forms. The results showed that across all the groups of clinical experience, nurses perceived the demanded competence levels to be higher than their actual competence levels. However, turnover intentions were not related to nurses' perceptions of demanded competence and were negatively related to perceptions of actual competence. The levels of competence demanded should not be considered as threats for nurses. Improving nurses' competence may reduce their turnover intentions.

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

PubMed

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

2014-05-01

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

Prosthesis use in adult acquired major upper-limb amputees: patterns of wear, prosthetic skills and the actual use of prostheses in activities of daily life.

PubMed

Østlie, Kristin; Lesjø, Ingrid Marie; Franklin, Rosemary Joy; Garfelt, Beate; Skjeldal, Ola Hunsbeth; Magnus, Per

2012-11-01

To describe patterns of prosthesis wear and perceived prosthetic usefulness in adult acquired upper-limb amputees (ULAs). To describe prosthetic skills in activities of daily life (ADL) and the actual use of prostheses in the performance of ADL tasks. To estimate the influence of prosthetic skills on actual prosthesis use and the influence of background factors on prosthetic skills and actual prosthesis use. Cross-sectional study analysing population-based questionnaire data (n = 224) and data from interviews and clinical testing in a referred/convenience sample of prosthesis-wearing ULAs (n = 50). Effects were analysed using linear regression. 80.8% wore prostheses. 90.3% reported their most worn prosthesis as useful. Prosthetic usefulness profiles varied with prosthetic type. Despite demonstrating good prosthetic skills, the amputees reported actual prosthesis use in only about half of the ADL tasks performed in everyday life. In unilateral amputees, increased actual use was associated with sufficient prosthetic training and with the use of myoelectric vs cosmetic prostheses, regardless of amputation level. Prosthetic skills did not affect actual prosthesis use. No background factors showed significant effect on prosthetic skills. Most major ULAs wear prostheses. Individualised prosthetic training and fitting of myoelectric rather than passive prostheses may increase actual prosthesis use in ADL.

Let's not, and say we would: imagined and actual responses to witnessing homophobia.

PubMed

Crosby, Jennifer Randall; Wilson, Johannes

2015-01-01

We compared imagined versus actual affective and behavioral responses to witnessing a homophobic slur. Participants (N = 72) witnessed a confederate using a homophobic slur, imagined the same scenario, or were not exposed to the slur. Those who imagined hearing the slur reported significantly higher levels of negative affect than those who actually witnessed the slur, and nearly one half of them reported that they would confront the slur, whereas no participants who actually heard the slur confronted it. These findings reveal a discrepancy between imagined and real responses to homophobic remarks, and they have implications for the likelihood that heterosexuals will actually confront homophobic remarks.

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

PubMed

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 < 0.05. In the pre-implementation period, there were 49 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.

Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols

PubMed Central

Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P.; Kumar, Ambuj

2011-01-01

Objectives To assess whether reported methodological quality of randomized controlled trials (RCTs) reflect the actual methodological quality, and to evaluate the association of effect size (ES) and sample size with methodological quality. Study design Systematic review Setting Retrospective analysis of all consecutive phase III RCTs published by 8 National Cancer Institute Cooperative Groups until year 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Results 429 RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94, 95%CI: 0.88, 0.99) and 24% (RHR: 1.24, 95%CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. Conclusion The largest study to-date shows poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. PMID:22424985

The Thurgood Marshall School of Law Empirical Findings: A Report of the 2012 Friday Academy Attendance and Statistical Comparisons of 1L GPA (Predicted and Actual)

ERIC Educational Resources Information Center

Kadhi, T.; Rudley, D.; Holley, D.; Krishna, K.; Ogolla, C.; Rene, E.; Green, T.

2010-01-01

The following report of descriptive statistics addresses the attendance of the 2012 class and the average Actual and Predicted 1L Grade Point Averages (GPAs). Correlational and Inferential statistics are also run on the variables of Attendance (Y/N), Attendance Number of Times, Actual GPA, and Predictive GPA (Predictive GPA is defined as the Index…

Changes in actual and perceived physical abilities in clinically obese children: a 9-month multi-component intervention study.

PubMed

Morano, Milena; Colella, Dario; Rutigliano, Irene; Fiore, Pietro; Pettoello-Mantovani, Massimo; Campanozzi, Angelo

2012-01-01

(1) To examine relationships among changes in physical activity, physical fitness and some psychosocial determinants of activity behavior in a clinical sample of obese children involved in a multi-component program; (2) to investigate the causal relationship over time between physical activity and one of its strongest correlates (i.e. perceived physical ability). Self-reported physical activity and health-related fitness tests were administered before and after a 9-month intervention in 24 boys and 20 girls aged 8 to 11 years. Individuals' perceptions of strength, speed and agility were assessed using the Perceived Physical Ability Scale, while body image was measured using Collins' Child Figure Drawings. Findings showed that body mass index, physical activity, performances on throwing and weight-bearing tasks, perceived physical ability and body image significantly improved after treatment among obese children. Gender differences were found in the correlational analyses, showing a link between actual and perceived physical abilities in boys, but not in girls. For the specific measurement interval of this study, perception of physical ability was an antecedent and not a potential consequence of physical activity. Results indicate that a multi-component activity program not based merely on a dose-effect approach enhances adherence of the participants and has the potential to increase the lifelong exercise skills of obese children. Rather than focusing entirely on diet and weight loss, findings support the inclusion of interventions directed toward improving perceived physical ability that is predictive of subsequent physical activity.

Clinical nurse specialist education: actualizing the systems leadership competency.

PubMed

Thompson, Cathy J; Nelson-Marten, Paula

2011-01-01

The purpose of this article was to show how sequenced educational strategies aid in the acquisition of systems leadership and change agent skills, as well as other essential skills for professional clinical nurse specialist (CNS) practice. Clinical nurse specialist education offers the graduate student both didactic and clinical experiences to help the student transition into the CNS role. Clinical nurse specialist faculty have a responsibility to prepare students for the realities of advanced practice. Systems leadership is an integral competency of CNS practice. The contemporary CNS is to be a leader in the translation of evidence into practice. To assist students to acquire this competency, all CNS students are expected to use research and other sources of evidence to identify, design, implement, and evaluate a specific practice change. Anecdotal comments from students completing the projects are offered. Student projects have been focused in acute and critical care, palliative care, and adult/gerontologic health clinical settings; community outreach has been the focus of a few change projects. Examples of student projects related to the systems leadership competency and correlated to the spheres of influence impacted are presented.

Clinical cancer advances 2007: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

PubMed

Gralow, Julie; Ozols, Robert F; Bajorin, Dean F; Cheson, Bruce D; Sandler, Howard M; Winer, Eric P; Bonner, James; Demetri, George D; Curran, Walter; Ganz, Patricia A; Kramer, Barnett S; Kris, Mark G; Markman, Maurie; Mayer, Robert J; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory H; Sawaya, Raymond; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Davidson, Nancy E; Schilsky, Richard L; Lichter, Allen S

2008-01-10

A MESSAGE FROM ASCO'S PRESIDENT: For the third year, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant cancer research presented or published over the past year. ASCO publishes this report to demonstrate the important progress being made on the front lines of clinical cancer research today. The report is intended to give all those with an interest in cancer care-the general public, cancer patients and organizations, policymakers, oncologists, and other medical professionals-an accessible summary of the year's most important cancer research advances. These pages report on the use of magnetic resonance imaging for breast cancer screening, the association between hormone replacement therapy and breast cancer incidence, the link between human papillomavirus and head and neck cancers, and the use of radiation therapy to prevent lung cancer from spreading. They also report on effective new targeted therapies for cancers that have been historically difficult to treat, such as liver cancer and kidney cancer, among many others. A total of 24 advances are featured in this year's report. These advances and many more over the past several years show that the nation's long-term investment in cancer research is paying off. But there are disturbing signs that progress could slow. We are now in the midst of the longest sustained period of flat government funding for cancer research in history. The budgets for the National Institutes of Health and the National Cancer Institute (NCI) have been unchanged for four years. When adjusted for inflation, cancer research funding has actually declined 12% since 2004. These budget constraints limit the NCI's ability to fund promising cancer research. In the past several years the number of grants that the NCI has been able to fund has significantly decreased; this year, in response to just the

Implications of Self-Deception for Self-Reported Intrinsic and Extrinsic Motivational Dispositions and Actual Learning Performance: A Higher Order Structural Model

ERIC Educational Resources Information Center

Hirschfeld, Robert R.; Thomas, Christopher H.; McNatt, D. Brian

2008-01-01

The authors explored implications of individuals' self-deception (a trait) for their self-reported intrinsic and extrinsic motivational dispositions and their actual learning performance. In doing so, a higher order structural model was developed and tested in which intrinsic and extrinsic motivational dispositions were underlying factors that…

Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols.

PubMed

Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P; Kumar, Ambuj

2012-06-01

To assess whether the reported methodological quality of randomized controlled trials (RCTs) reflects the actual methodological quality and to evaluate the association of effect size (ES) and sample size with methodological quality. Systematic review. This is a retrospective analysis of all consecutive phase III RCTs published by eight National Cancer Institute Cooperative Groups up to 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Four hundred twenty-nine RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94; 95% confidence interval [CI]: 0.88, 0.99) and 24% (RHR: 1.24; 95% CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. The largest study to date shows that poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. Copyright © 2012 Elsevier Inc. All rights reserved.

Self-Reported and Actual Use of Proactive and Reactive Classroom Management Strategies and Their Relationship with Teacher Stress and Student Behaviour

ERIC Educational Resources Information Center

Clunies-Ross, Penny; Little, Emma; Kienhuis, Mandy

2008-01-01

This study investigated the relationship between primary school teachers' self-reported and actual use of classroom management strategies, and examined how the use of proactive and reactive strategies is related to teacher stress and student behaviour. The total sample consisted of 97 teachers from primary schools within Melbourne. Teachers…

Clinically expedient reporting of rapid diagnostic test information.

PubMed

Doern, G V

1986-03-01

With the development of rapid diagnostic tests in the clinical microbiology laboratory has come an awareness of the importance of rapid results reporting. Clearly, the potential clinical impact of rapid diagnostic tests is dependent on expeditious reporting. Traditional manual reporting systems are encumbered by the necessity of transcription of test information onto hard copy reports and then the subsequent distribution of such reports into the hands of the user. Laboratory computers when linked directly to CRTs located in nursing stations, ambulatory clinics, or physician's offices, both inside and outside of the hospital, permit essentially instantaneous transfer of test results from the laboratory to the clinician. Computer-assisted results reporting, while representing a significant advance over manual reporting systems is not, however, without problems. Concerns include validation of test information, authorization of users with access to test information, mechanical integrity, and cost. These issues notwithstanding, computerized results reporting will undoubtedly play a central role in optimizing the clinical impact of rapid diagnostic tests.

The effect of communicating the genetic risk of cardiometabolic disorders on motivation and actual engagement in preventative lifestyle modification and clinical outcome: a systematic review and meta-analysis of randomised controlled trials.

PubMed

Li, Sherly X; Ye, Zheng; Whelan, Kevin; Truby, Helen

2016-09-01

Genetic risk prediction of chronic conditions including obesity, diabetes and CVD currently has limited predictive power but its potential to engage healthy behaviour change has been of immense research interest. We aimed to understand whether the latter is indeed true by conducting a systematic review and meta-analysis investigating whether genetic risk communication affects motivation and actual behaviour change towards preventative lifestyle modification. We included all randomised controlled trials (RCT) since 2003 investigating the impact of genetic risk communication on health behaviour to prevent cardiometabolic disease, without restrictions on age, duration of intervention or language. We conducted random-effects meta-analyses for perceived motivation for behaviour change and clinical changes (weight loss) and a narrative analysis for other outcomes. Within the thirteen studies reviewed, five were vignette studies (hypothetical RCT) and seven were clinical RCT. There was no consistent effect of genetic risk on actual motivation for weight loss, perceived motivation for dietary change (control v. genetic risk group standardised mean difference (smd) -0·15; 95 % CI -1·03, 0·73, P=0·74) or actual change in dietary behaviour. Similar results were observed for actual weight loss (control v. high genetic risk SMD 0·29 kg; 95 % CI -0·74, 1·31, P=0·58). This review found no clear or consistent evidence that genetic risk communication alone either raises motivation or translates into actual change in dietary intake or physical activity to reduce the risk of cardiometabolic disorders in adults. Of thirteen studies, eight were at high or unclear risk of bias. Additional larger-scale, high-quality clinical RCT are warranted.

Who is Self-Actualized?

ERIC Educational Resources Information Center

Roweton, William E.

1981-01-01

In an attempt to clarify Maslow's concept of self-actualization as it relates to human motivation, a class of educational psychology students wrote essays describing a self-actualized person and then attempted to decide whether public schools contribute to the production of self-actualized persons. Two-thirds of the students decided that schools…

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

PubMed Central

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

2016-01-01

There are overwhelming reports and descriptions about celiac associated disorders. Although there is a clear genetic association between celiac disease (CD) and some gastrointestinal disorders, there are controversial reports claiming an association between CD and Helicobacter pylori (H. pylori) infection. Different studies indicated the possible association between lymphocytic gastritis and both CD and H. pylori infection, although this evidence is not consistently accepted. Also it was shown that an increase in intraepithelial lymphocytes count is associated with both H. pylori infection and celiac disease. Therefore the following questions may raise: how far is this infection actually related to CD?, which are the underlying patho-mechanisms for these associations? what are the clinical implications? what is the management? and what would be the role of gluten free diet in treating these conditions? PubMed (PubMed Central), Ovid, ISI of web knowledge, and Google scholar were searched for full text articles published between 1985 and 2015. The associated keywords were used, and papers described particularly the impact of pathological and clinical correlation between CD and H. pylori infection were identified. In this review we tried to answer the above questions and discussed some of the recent developments in the pathological and clinical aspects of CD and H. pylori infection. PMID:27252814

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

PubMed

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

2016-04-01

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

Neuropsychology and Rehabilitation Services in the United States: Brief Report from a Survey of Clinical Neuropsychologists.

PubMed

Block, Cady; Santos, Octavio A; Flores-Medina, Yvonne; Rivera Camacho, Diego Fernando; Arango-Lasprilla, Juan Carlos

2017-05-01

To provide a brief presentation of preliminary data on rehabilitation services provided by clinical neuropsychologists within the United States. This survey utilized data extracted from a larger international research study conducted in 39 countries including N = 173 professionals who reported to engage in neuropsychological rehabilitative services within the past year (63.6% female, 44.36 ± 11.83 years of age) took part in the study. Neuropsychologists providing rehabilitation services in the United States in the past year were more likely to provide individual versus group therapy, likely to employ technology (e.g., personal computers, mobile phones/smartphones) as part of treatment services, see a range of diagnostic groups most prominently traumatic brain injury and stroke/vascular conditions, and work to address a range of both cognitive (e.g., memory, attention/concentration, and executive functioning) and psychological (e.g., emotional/behavioral adjustment and well-being, awareness of disability/disease) issues. Prior published surveys suggest that clinical neuropsychologists have a growing involvement in rehabilitation services within the United States but with little clarity as to the actual characteristics of actual professional activities and practices. The present study aimed to provide such information and hopefully will be helpful in promoting additional systematic studies in this area. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Legal repercussions of Clinical Ethics Committees reports].

PubMed

Couceiro V, Azucena; Beca I, Juan Pablo

2006-04-01

Clinical Ethics Committees and Research Ethics Committees have their own specific roles. The Clinical Ethics Committee's pronouncements have an advisory function, whereas Research Ethics Committees' decisions are binding. This article analyzes the legal impact of the Clinical Ethics Committees' reports. Legal and medical reasoning share the same practical nature. Both can have several correct answers to the same situation. Clinical Ethics Committees deliberate about these alternatives and analyze the involved values. Their conclusions are non-compulsory recommendations. They do not replace nor diminish the doctor's personal responsibility. Even though the Clinical Ethics Committees' reports are not binding, they constitute a sort of "expert's opinion", expressed by qualified professionals, who assume their own professional responsibility as advisors. The members' behavior is necessarily subject to constitutional and legal regulations. When judges review the Clinical Ethics Committee's reports, they must realize that their nature is advisory, and also consider them an essential element to reduce the gap between the medical and legal fields. In this way, the problem of increasingly transforming medicine into a legal issue can be prevented.

First report of clinical presentation of a bite by a running spider, Philodromus sp. (Araneae: Philodromidae), with recommendations for spider bite management.

PubMed

Coetzee, Maureen; Dippenaar, Ansie; Frean, John; Hunt, Richard H

2017-06-30

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 showing cytotoxic envenomation. Management of the bites should be as recommended for other cytotoxic spider bites.

What Do Primary School Heads Actually Do All Day?

ERIC Educational Resources Information Center

Clerkin, Ciaran

1988-01-01

Reports a study which examines the role of the head teacher as described in official reports, analyzing data from interviews and time diaries to determine their actual duties. Concludes that headteachers spend much of their time on daily school maintenance, stating that if duties were delegated, headteachers could more effectively focus on…

Anatomy of a Joint: Comparing Self-Reported and Actual Dose of Cannabis and Tobacco in a Joint, and How These Are Influenced by Controlled Acute Administration.

PubMed

Hindocha, Chandni; Freeman, Tom P; Curran, H Valerie

2017-01-01

Introduction: Major gaps exist in the measurement of cannabis exposure. The accuracy of self-reported cannabis and tobacco dose per joint is poorly characterized and has never been investigated following acute cannabis/tobacco exposure. Using an innovative "Roll a Joint" paradigm, this study aims to (1) compare estimated and actual dose of cannabis and tobacco per joint at baseline and (2) examine the acute effects of cannabis and/or tobacco on estimated and actual dose. Materials and Methods: We investigated this by using a randomized, double-blind, placebo-controlled crossover 2 (active cannabis, placebo cannabis)×2 (active tobacco, placebo tobacco) design in a laboratory setting. Participants were 24 recreational cousers of cannabis and tobacco. At baseline, they were asked to measure out the amount of cannabis and tobacco they would put in an average joint for themselves (dose per joint). Then, on each of four drug administration sessions, participants were again asked to do this for a joint they would want to smoke "right now." Self-reported and actual amount was recorded (g). Results: At baseline, the estimated amount of cannabis per joint (0.28±0.23 g) was double the actual amount (0.14±0.12 g) ( p =0.003, d =0.723). No difference emerged between estimated (0.43±0.25 g) and actual (0.35±0.15 g) ( p =0.125) amount of tobacco per joint. Compared to placebo, active cannabis reduced the actual dose of both cannabis ( p =0.035) and tobacco ( p <0.001) they put in a joint. Participants accurately estimated this reduction for tobacco ( p =0.014), but not for cannabis ( p =0.680). Conclusions: Self-reported dose per joint is accurate for tobacco but dramatically overestimates cannabis exposure and therefore should be viewed with caution. Cannabis administration reduced the amount of cannabis and tobacco added to joints, suggesting a reduction in dose during a smoking session. The "Roll A Joint" paradigm should be implemented for better accuracy in

The Actual and Ideal Sexual Self Concept in the Context of Genital Pain Using Implicit and Explicit Measures.

PubMed

Dewitte, Marieke; De Schryver, Maarten; Heider, Niclas; De Houwer, Jan

2017-05-01

The experience of pain during sexual intercourse generates significant distress and sexual impairments, which is likely to affect sexual identity and become a threat to the sense of self. To explore the role of the concept of the sexual self in the context of genital pain by measuring different states of self (ie, actual vs ideal) at different levels of responding (ie, explicit vs implicit) and examine their associations with sexual, emotional, and pain-related variables. Thirty young women who identified with genital pain and 29 women without pain completed (i) two versions of the Relational Responding Task as a measurement of implicit actual and ideal sexual self; (ii) explicit ratings of the actual and the ideal sexual self; and (iii) measurements of sexual self-esteem, global self-esteem, depression, sexual satisfaction, sexual distress or depression, sexual frequency, and pain experiences. Women with genital pain scored lower on the explicit and implicit actual-self measurements than women without pain but did not differ in their ideal self. Furthermore, the pain group reported higher ideal- than actual-self scores at the explicit level. Actual- and ideal-self measurements had differential effects on sexual, emotional, and behavioral outcome variables. In general, rating the ideal self higher than the actual self was related to more negative outcomes. Pain-related variables were predicted only by the implicit measurements, showing that the high pain group reported more pain, fear of pain, and a stronger tendency to continue with sex despite the pain when perceiving themselves as sexually less competent and when this perception did not match their ideal self. Therapeutic interventions might benefit from discussing women's internal guides for self, decreasing potential discrepancies, and developing identity-related motivational treatments that target the emotional discomfort and maladaptive behavioral strategies that result from trying to conform with their

Changes In Actual And Perceived Physical Abilities In Clinically Obese Children: A 9-Month Multi-Component Intervention Study

PubMed Central

Morano, Milena; Colella, Dario; Rutigliano, Irene; Fiore, Pietro; Pettoello-Mantovani, Massimo; Campanozzi, Angelo

2012-01-01

Objectives (1) To examine relationships among changes in physical activity, physical fitness and some psychosocial determinants of activity behavior in a clinical sample of obese children involved in a multi-component program; (2) to investigate the causal relationship over time between physical activity and one of its strongest correlates (i.e. perceived physical ability). Methods Self-reported physical activity and health-related fitness tests were administered before and after a 9-month intervention in 24 boys and 20 girls aged 8 to 11 years. Individuals’ perceptions of strength, speed and agility were assessed using the Perceived Physical Ability Scale, while body image was measured using Collins’ Child Figure Drawings. Results Findings showed that body mass index, physical activity, performances on throwing and weight-bearing tasks, perceived physical ability and body image significantly improved after treatment among obese children. Gender differences were found in the correlational analyses, showing a link between actual and perceived physical abilities in boys, but not in girls. For the specific measurement interval of this study, perception of physical ability was an antecedent and not a potential consequence of physical activity. Conclusions Results indicate that a multi-component activity program not based merely on a dose-effect approach enhances adherence of the participants and has the potential to increase the lifelong exercise skills of obese children. Rather than focusing entirely on diet and weight loss, findings support the inclusion of interventions directed toward improving perceived physical ability that is predictive of subsequent physical activity. PMID:23239985

Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage?

PubMed Central

Bessone, Fernando

2010-01-01

Non-steroidal anti-inflammatory drugs (NSAIDs) constitute a family of drugs, which taken as a group, represents one of the most frequently prescribed around the world. Thus, not surprisingly NSAIDs, along with anti-infectious agents, list on the top for causes of Drug-Induced Liver Injury (DILI). The incidence of liver disease induced by NSAIDs reported in clinical studies is fairly uniform ranging from 0.29/100 000 [95% confidence interval (CI): 0.17-051] to 9/100 000 (95% CI: 6-15). However, compared with these results, a higher risk of liver-related hospitalizations was reported (3-23 per 100 000 patients). NSAIDs exhibit a broad spectrum of liver damage ranging from asymptomatic, transient, hyper-transaminasemia to fulminant hepatic failure. However, under-reporting of asymptomatic, mild cases, as well as of those with transient liver-tests alteration, in conjunction with reports non-compliant with pharmacovigilance criteria to ascertain DILI and flawed epidemiological studies, jeopardize the chance to ascertain the actual risk of NSAIDs hepatotoxicity. Several NSAIDs, namely bromfenac, ibufenac and benoxaprofen, have been withdrawn from the market due to hepatotoxicity; others like nimesulide were never marketed in some countries and withdrawn in others. Indeed, the controversy concerning the actual risk of severe liver disease persists within NSAIDs research. The present work intends (1) to provide a critical analysis of the dissimilar results currently available in the literature concerning the epidemiology of NSAIDS hepatotoxicity; and (2) to review the risk of hepatotoxicity for each one of the most commonly employed compounds of the NSAIDs family, based on past and recently published data. PMID:21128314

Compliance with results reporting at ClinicalTrials.gov.

PubMed

Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert M

2015-03-12

The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic

Overlooked Management and Risk Factors for Anemia in Patients with Intestinal Behçet's Disease in Actual Clinical Practice.

PubMed

Kim, Bun; Park, Soo Jung; Hong, Sung Pil; Cheon, Jae Hee; Kim, Tae Il; Kim, Won Ho

2015-11-23

Anemia in patients with inflammatory bowel disease significantly affects the quality of life. The aim of this study was to investigate the frequency of and risk factors for anemia and to describe the management of anemia in patients with intestinal Behçet's disease (BD) in actual clinical practice. We included 64 patients with intestinal BD who visited the outpatient clinic of a tertiary referral center in June 2011 and had available laboratory data for the subsequent 6 months. Anemia was detected in 26 patients (40.6%). After 6 months, anemia was still present in 14 of these patients (53.8%). The cause of anemia was investigated in eight patients (30.8%), and oral iron supplementation was prescribed to four patients (15.4%). Of these four patients, two (50%) recovered completely within 6 months. Anemia was associated with a high Disease Activity Index for Intestinal Behçet's Disease (DAIBD, p=0.024), erythrocyte sedimentation rate (p=0.003), and C-reactive protein (p=0.049) in univariate analysis. In multivariate analysis, the factor predictive for anemia in patients with intestinal BD was a higher DAIBD (≥40; odds ratio, 4.08; 95% confidence interval, 1.21 to 13.71; p=0.023). Although anemia is common in intestinal BD patients, its clinical importance is overlooked in daily practice. Moderate to severe disease activity is predictive of anemia.

Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials.

PubMed

Hodkinson, Alex; Gamble, Carrol; Smith, Catrin Tudur

2016-04-22

The quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials. Publications related to clinical trials of orlistat were identified through comprehensive literature searches. A request was made to Roche (Genentech; South San Francisco, CA, USA) for clinical study reports related to the orlistat trials identified in our search. We compared adverse events, serious adverse events, and the reporting of 15 harms criteria in both document types and compared meta-analytic results using data from the clinical study reports against the journal publications. Five journal publications with matching clinical study reports were available for five independent clinical trials. Journal publications did not always report the complete list of identified adverse events and serious adverse events. We found some differences in the magnitude of the pooled risk difference between both document types with a statistically significant risk difference for three adverse events and two serious adverse events using data reported in the clinical study reports; these events were of mild intensity and unrelated to the orlistat. The CONSORT harms reporting criteria were often satisfied in the methods section of the clinical study reports (70-90 % of the methods section criteria satisfied in the clinical study reports compared to 10-50 % in the journal publications), but both document types satisfied 80-100 % of the results section criteria, albeit with greater detail being provided in the clinical study reports. In this case study, journal publications provided insufficient information on harms outcomes of clinical trials and did not specify

[Writing and publication of a clinical case report].

PubMed

Târcoveanu, E; Roca, M; Mihăescu, T

2011-01-01

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

Anatomy of a Joint: Comparing Self-Reported and Actual Dose of Cannabis and Tobacco in a Joint, and How These Are Influenced by Controlled Acute Administration

PubMed Central

Hindocha, Chandni; Freeman, Tom P.; Curran, H. Valerie

2017-01-01

Abstract Introduction: Major gaps exist in the measurement of cannabis exposure. The accuracy of self-reported cannabis and tobacco dose per joint is poorly characterized and has never been investigated following acute cannabis/tobacco exposure. Using an innovative “Roll a Joint” paradigm, this study aims to (1) compare estimated and actual dose of cannabis and tobacco per joint at baseline and (2) examine the acute effects of cannabis and/or tobacco on estimated and actual dose. Materials and Methods: We investigated this by using a randomized, double-blind, placebo-controlled crossover 2 (active cannabis, placebo cannabis)×2 (active tobacco, placebo tobacco) design in a laboratory setting. Participants were 24 recreational cousers of cannabis and tobacco. At baseline, they were asked to measure out the amount of cannabis and tobacco they would put in an average joint for themselves (dose per joint). Then, on each of four drug administration sessions, participants were again asked to do this for a joint they would want to smoke “right now.” Self-reported and actual amount was recorded (g). Results: At baseline, the estimated amount of cannabis per joint (0.28±0.23 g) was double the actual amount (0.14±0.12 g) (p=0.003, d=0.723). No difference emerged between estimated (0.43±0.25 g) and actual (0.35±0.15 g) (p=0.125) amount of tobacco per joint. Compared to placebo, active cannabis reduced the actual dose of both cannabis (p=0.035) and tobacco (p<0.001) they put in a joint. Participants accurately estimated this reduction for tobacco (p=0.014), but not for cannabis (p=0.680). Conclusions: Self-reported dose per joint is accurate for tobacco but dramatically overestimates cannabis exposure and therefore should be viewed with caution. Cannabis administration reduced the amount of cannabis and tobacco added to joints, suggesting a reduction in dose during a smoking session. The “Roll A Joint” paradigm should be implemented for better accuracy

The reporting of clinical signs in laboratory animals: FELASA Working Group Report.

PubMed

Fentener van Vlissingen, J M; Borrens, M; Girod, A; Lelovas, P; Morrison, F; Torres, Y Saavedra

2015-10-01

Observing and reporting clinical signs in laboratory animals is necessary for many reasons: the assessment of animal welfare, compliance with the principle of refinement (e.g. humane endpoints), regulatory compliance (e.g. reporting severity) and, importantly, as a scientific outcome, e.g. in animal models of disease or safety studies. Developments in the reporting of clinical signs will enhance the scientific value gained from animal experiments and further address the ethical cost. This paper discusses systematic approaches to the observation and reporting of clinical signs in animals (to be) used for research. Glossaries from public and corporate institutions have been consulted and a reference glossary has been set up, providing terminology to be tailored for institutional or project-specific use. The clinical examination of animals must be carried out by competent and specifically trained staff in a systematic way and repeated at adequate intervals and clinical observations must be registered effectively to allow this information to be used. The development of institutional or project-specific glossaries and the use of handwritten records or automated databases are discussed in detail. Among the users are animal care staff, veterinarians and researchers who will need to agree on a given set of clinical signs to be monitored routinely or as a scientific read-out and to train for the proper application. The paper introduces a long list of clinical signs with scientific terminology, descriptions and explanations as a reference glossary to be published and maintained online as a living document supported by the authors as an editorial committee. © The Author(s) 2015.

How much alcohol do you buy? A comparison of self-reported alcohol purchases with actual sales.

PubMed

Ramstedt, Mats

2010-04-01

Unrecorded alcohol has increased in the Nordic countries during recent years, above all in terms of cross-border trade. This implies that trends and levels of per capita consumption would look different without estimates of this source of alcohol, estimates that in Sweden and other countries are made through surveys. The overall aim is to analyse the validity of Swedish survey estimates of alcohol bought in the cross-border trade and possibly to develop weights that can be applied to such estimates. The analysis consists of comparing self-reported purchases of spirits, wine, cider/alcopops and beer at retail monopoly (Systembolaget) during 2008 (n = 18,000) with actual sales during the same period overall and monthly. Of the recorded amount of purchases at Systembolaget, 87% was reported in the survey, compared with the 40-60% usually found for self-reported consumption. Significant differences across beverages were revealed, showing a lower coverage rate for beer and spirits and a higher coverage rate for wine and cider. Changes in purchases of all beverages were captured fairly well, at least changes taking place from one month to another. Self-reported alcohol purchases achieve a higher coverage rate than found typically in studies based on self-reported use of alcohol. If adjustments are to be made to correct for underreporting in self-reported data on alcohol purchases, different weights should be applied to different beverages. Furthermore, at least major changes in how much alcohol is purchased in the population can be monitored using well-designed population surveys.

Actual change and inaccurate recall contribute to posttraumatic growth following radiotherapy.

PubMed

Ransom, Sean; Sheldon, Kennon M; Jacobsen, Paul B

2008-10-01

People with cancer often report that they experience personal growth as a result of the disease, but such reports have unclear validity. Some suggest such growth results from Rogers's (1951) hypothesized organismic valuing process (OVP), an innate tendency for people to gravitate toward well-being; others suggest this growth may be a positive illusion resulting from temporal self-comparisons. To test these conceptualizations, the authors examined 83 individuals with Stages 0-III breast or prostate cancer. Patients completed measures of positive attributes and personal life goals before radiotherapy (Time 1) and after radiotherapy (Time 2). At Time 2, participants also attempted to recreate their Time 1 responses and completed a posttraumatic growth (PTG) measure. PTG was significantly related with actual increases (but not perceived increases) in the relative importance of intrinsic goals versus extrinsic goals and with perceived increases (but not actual increases) in positive attributes. These measures were unrelated to one another and thus explained unique variance in PTG. Data suggest that both actual change processes related to the OVP and biases in autobiographic recall may independently contribute to PTG reports. (c) 2008 APA, all rights reserved.

Clinical report writing: Process and perspective

NASA Technical Reports Server (NTRS)

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.

Impact of voice- and knowledge-enabled clinical reporting--US example.

PubMed

Bushko, Renata G; Havlicek, Penny L; Deppert, Edward; Epner, Stephen

2002-01-01

This study shows qualitative and quantitative estimates of the national and the clinic level impact of utilizing voice and knowledge enabled clinical reporting systems. Using common sense estimation methodology, we show that the delivery of health care can experience a dramatic improvement in four areas as a result of the broad use of voice and knowledge enabled clinical reporting: (1) Process Quality as measured by cost savings, (2) Organizational Quality as measured by compliance, (3) Clinical Quality as measured by clinical outcomes and (4) Service Quality as measured by patient satisfaction. If only 15 percent of US physicians replaced transcription with modem clinical reporting voice-based methodology, about one half billion dollars could be saved. $6.7 Billion could be saved annually if all medical reporting currently transcribed was handled with voice-and knowledge-enabled dictation and reporting systems.

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

PubMed

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

2012-01-03

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

The impact of biologic therapy in chronic plaque psoriasis from a societal perspective: an analysis based on Italian actual clinical practice.

PubMed

Polistena, B; Calzavara-Pinton, P; Altomare, G; Berardesca, E; Girolomoni, G; Martini, P; Peserico, A; Puglisi Guerra, A; Spandonaro, F; Vena Gino, A; Chimenti, S; Ayala, F

2015-12-01

Psoriasis is one of the most common forms of chronic dermatitis, affecting 2-3% of the worldwide population. It has a serious effect on the way patients perceive themselves and others, thereby prejudicing their quality of life and giving rise to a significant deterioration in their psycho-physical well-being; it also poses greater difficulties for them in leading a normal social life, including their ability to conduct a normal working life. All the above-mentioned issues imply a cost for the society. This study proposes to evaluate the impact on societal costs for the treatment of chronic plaque psoriasis with biologics (etanercept, infliximab and adalimumab) in the Italian clinical practice. A prospective observational study has been conducted in 12 specialized centres of the Psocare network, located throughout Italy. Direct and indirect costs (as well as the health-related quality of life of patients with plaque psoriasis undergoing biologic treatments) have been estimated, while the societal impact has been determined using a cost-utility approach. Non-medical and indirect costs account for as much as 44.97% of the total cost prior to treatment and to 6.59% after treatment, with an overall 71.38% decrease. Adopting a societal perspective in the actual clinical practice of the Italian participating centres, the ICER of biologic therapies for treating plaque psoriasis amounted to €18634.40 per QALY gained--a value far from the €28656.30 obtained by adopting a third-party payer perspective. Our study confirms that chronic psoriasis subjects patients to a considerable burden, together with their families and caregivers, stressing how important it is to take the societal perspective into consideration during the appraisal process. Besides, using data derived from Italian actual practice, treatment with biologics shows a noteworthy benefit in social terms. © 2015 European Academy of Dermatology and Venereology.

Prevalence of Estimated GFR Reporting Among US Clinical Laboratories

PubMed Central

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

2008-01-01

Background Routine laboratory reporting of estimated glomerular filtration rate (eGFR) may help clinicians detect kidney disease. The current national prevalence of eGFR reporting among clinical laboratories is unknown, thus the extent of the situation of laboratories not routinely reporting eGFR with serum creatinine (SCr) results is not quantified. Design Observational analysis. Setting National Kidney Disease Education Program survey of clinical laboratory conducted in 2006-7 by mail, Web, and telephone follow up. Participants A national random sample, 6,350 clinical laboratories, drawn from the Federal Clinical Laboratory Improvement Amendments database and stratified by six major laboratory types/groupings. Predictors Laboratory reports SCr results. Outcomes Reporting eGFR values along with SCr results. Measurements Percent of laboratories reporting eGFR along with reporting SCr, reporting protocol, eGFR formula used, and style of reporting cutoff values. Results Among laboratories reporting SCr, 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%; others, 43.2%). Physician office laboratories have a reporting prevalence lower than other laboratory types (p < 0.001). Among laboratories reporting eGFR, 66.7% do so routinely with all adult SCr 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 m2” reporting convention. Independent laboratories are least likely to routinely report eGFR, (50.6%, p < .05) and most likely to report only when specifically requested (45.4%, p < 0.05). High-volume laboratories across all strata are more likely to report eGFR (p < 0.001). Limitations Self-reporting by laboratories, Federal database did not have names of laboratory directors/managers (intended respondents), assumed accuracy of Federal database for sample purposes. Conclusions Routine e

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

PubMed

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.

Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.

PubMed

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

2015-07-01

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

A comparison of cost effectiveness using data from randomized trials or actual clinical practice: selective cox-2 inhibitors as an example.

PubMed

van Staa, Tjeerd-Pieter; Leufkens, Hubert G; Zhang, Bill; Smeeth, Liam

2009-12-01

Data on absolute risks of outcomes and patterns of drug use in cost-effectiveness analyses are often based on randomised clinical trials (RCTs). The objective of this study was to evaluate the external validity of published cost-effectiveness studies by comparing the data used in these studies (typically based on RCTs) to observational data from actual clinical practice. Selective Cox-2 inhibitors (coxibs) were used as an example. The UK General Practice Research Database (GPRD) was used to estimate the exposure characteristics and individual probabilities of upper gastrointestinal (GI) events during current exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) or coxibs. A basic cost-effectiveness model was developed evaluating two alternative strategies: prescription of a conventional NSAID or coxib. Outcomes included upper GI events as recorded in GPRD and hospitalisation for upper GI events recorded in the national registry of hospitalisations (Hospital Episode Statistics) linked to GPRD. Prescription costs were based on the prescribed number of tables as recorded in GPRD and the 2006 cost data from the British National Formulary. The study population included over 1 million patients prescribed conventional NSAIDs or coxibs. Only a minority of patients used the drugs long-term and daily (34.5% of conventional NSAIDs and 44.2% of coxibs), whereas coxib RCTs required daily use for at least 6-9 months. The mean cost of preventing one upper GI event as recorded in GPRD was US$104k (ranging from US$64k with long-term daily use to US$182k with intermittent use) and US$298k for hospitalizations. The mean costs (for GPRD events) over calendar time were US$58k during 1990-1993 and US$174k during 2002-2005. Using RCT data rather than GPRD data for event probabilities, the mean cost was US$16k with the VIGOR RCT and US$20k with the CLASS RCT. The published cost-effectiveness analyses of coxibs lacked external validity, did not represent patients in actual clinical

On Actualizing Person-Centered Theory: A Critique of Textbook Treatments of Rogers' Motivational Constructs.

ERIC Educational Resources Information Center

Ford, J. Guthrie

1989-01-01

Gives an historical overview of Rogerian motivational constructs of actualization and self actualization. Reports the results of a survey of introductory textbooks relative to their treatment of Rogers' thinking. Suggests that individuals who wish to create a Rogerian presentation should incorporate the congruence/incongruence concept. (KO)

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

PubMed

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.

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

PubMed

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

2018-02-01

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

Comparing Perceptions with Actual Reports of Close Friend's HIV Testing Behavior Among Urban Tanzanian Men.

PubMed

Mulawa, Marta; Yamanis, Thespina J; Balvanz, Peter; Kajula, Lusajo J; Maman, Suzanne

2016-09-01

Men have lower rates of HIV testing and higher rates of AIDS-related mortality compared to women in sub-Saharan Africa. To assess whether there is an opportunity to increase men's uptake of testing by correcting misperceptions about testing norms, we compare men's perceptions of their closest friend's HIV testing behaviors with the friend's actual testing self-report using a unique dataset of men sampled within their social networks (n = 59) in Dar es Salaam, Tanzania. We examine the accuracy and bias of perceptions among men who have tested for HIV (n = 391) and compare them to the perceptions among men who never tested (n = 432). We found that testers and non-testers did not differ in the accuracy of their perceptions, though non-testers were strongly biased towards assuming that their closest friends had not tested. Our results lend support to social norms approaches designed to correct the biased misperceptions of non-testers to promote men's HIV testing.

Best clinical trials reported in 2010.

PubMed

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.

[Assessment of actual benefits of new drugs by the Transparency Committee].

PubMed

Le Jeunne, C

2008-01-01

When a drug has been granted a marketing authorization, if the pharmaceutical company wants it to be covered by the National Health Insurance, the company has to submit a file with all the studies concerning the drug, especially drug-drug comparative studies, to be assessed by the Transparency Committee. Drugs are assessed on two criteria: actual or expected benefit (AB) and improvement in actual benefit (IAB). Actual benefit mainly takes into account the severity of the disease concerned, the level of efficacy relative to known side effects (risk-benefit ratio), and the place the drug is intended to take in the therapeutic strategy. At the end of the assessment, AB is considered as important, moderate, poor or insufficient (to justify inclusion of the drug on the list of products to be reimbursed). After actual benefit is determined, improvement of actual benefit is assessed, comparing the estimated benefit of this drug with one of drugs with the same indication that is already reimbursed, to assess whether this drug will improve the patient's disease. This can be assessed by direct comparison (two drugs compared in the same clinical trial) or by indirect comparison (separate studies with the same design). There are four levels of added value, from I (major improvement) to IV (minor improvement). Level V represents no improvement. This second assessment is always relative to another drug. It never provides an absolute score. However, IAB is very important for pharmaceutical companies, because it is a fundamental criterion to determine the price of the drug, which is discussed with the Economic Committee of Health Products in a final phase. Actual benefit and improvement in actual benefit are allocated for each indication of a drug.

Can Some Marine-Derived Fungal Metabolites Become Actual Anticancer Agents?

PubMed Central

Gomes, Nelson G. M.; Lefranc, Florence; Kijjoa, Anake; Kiss, Robert

2015-01-01

Marine fungi are known to produce structurally unique secondary metabolites, and more than 1000 marine fungal-derived metabolites have already been reported. Despite the absence of marine fungal-derived metabolites in the current clinical pipeline, dozens of them have been classified as potential chemotherapy candidates because of their anticancer activity. Over the last decade, several comprehensive reviews have covered the potential anticancer activity of marine fungal-derived metabolites. However, these reviews consider the term “cytotoxicity” to be synonymous with “anticancer agent”, which is not actually true. Indeed, a cytotoxic compound is by definition a poisonous compound. To become a potential anticancer agent, a cytotoxic compound must at least display (i) selectivity between normal and cancer cells (ii) activity against multidrug-resistant (MDR) cancer cells; and (iii) a preferentially non-apoptotic cell death mechanism, as it is now well known that a high proportion of cancer cells that resist chemotherapy are in fact apoptosis-resistant cancer cells against which pro-apoptotic drugs have more than limited efficacy. The present review thus focuses on the cytotoxic marine fungal-derived metabolites whose ability to kill cancer cells has been reported in the literature. Particular attention is paid to the compounds that kill cancer cells through non-apoptotic cell death mechanisms. PMID:26090846

Can Some Marine-Derived Fungal Metabolites Become Actual Anticancer Agents?

PubMed

Gomes, Nelson G M; Lefranc, Florence; Kijjoa, Anake; Kiss, Robert

2015-06-19

Marine fungi are known to produce structurally unique secondary metabolites, and more than 1000 marine fungal-derived metabolites have already been reported. Despite the absence of marine fungal-derived metabolites in the current clinical pipeline, dozens of them have been classified as potential chemotherapy candidates because of their anticancer activity. Over the last decade, several comprehensive reviews have covered the potential anticancer activity of marine fungal-derived metabolites. However, these reviews consider the term "cytotoxicity" to be synonymous with "anticancer agent", which is not actually true. Indeed, a cytotoxic compound is by definition a poisonous compound. To become a potential anticancer agent, a cytotoxic compound must at least display (i) selectivity between normal and cancer cells (ii) activity against multidrug-resistant (MDR) cancer cells; and (iii) a preferentially non-apoptotic cell death mechanism, as it is now well known that a high proportion of cancer cells that resist chemotherapy are in fact apoptosis-resistant cancer cells against which pro-apoptotic drugs have more than limited efficacy. The present review thus focuses on the cytotoxic marine fungal-derived metabolites whose ability to kill cancer cells has been reported in the literature. Particular attention is paid to the compounds that kill cancer cells through non-apoptotic cell death mechanisms.

Clinical Cancer Advances 2013: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology.

PubMed

Patel, Jyoti D; Krilov, Lada; Adams, Sylvia; Aghajanian, Carol; Basch, Ethan; Brose, Marcia S; Carroll, William L; de Lima, Marcos; Gilbert, Mark R; Kris, Mark G; Marshall, John L; Masters, Gregory A; O'Day, Steven J; Polite, Blasé; Schwartz, Gary K; Sharma, Sunil; Thompson, Ian; Vogelzang, Nicholas J; Roth, Bruce J

2014-01-10

Since its founding in 1964, the American Society of Clinical Oncology (ASCO) has been committed to improving cancer outcomes through research and the delivery of quality care. Research is the bedrock of discovering better treatments--providing hope to the millions of individuals who face a cancer diagnosis each year. The studies featured in "Clinical Cancer Advances 2013: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology" represent the invaluable contributions of thousands of patients who participate in clinical trials and the scientists who conduct basic and clinical research. The insights described in this report, such as how cancers hide from the immune system and why cancers may become resistant to targeted drugs, enable us to envision a future in which cancer will be even more controllable and preventable. The scientific process is thoughtful, deliberate, and sometimes slow, but each advance, while helping patients, now also points toward new research questions and unexplored opportunities. Both dramatic and subtle breakthroughs occur so that progress against cancer typically builds over many years. Success requires vision, persistence, and a long-term commitment to supporting cancer research and training. Our nation's longstanding investment in federally funded cancer research has contributed significantly to a growing array of effective new treatments and a much deeper understanding of the drivers of cancer. But despite this progress, our position as a world leader in advancing medical knowledge and our ability to attract the most promising and talented investigators are now threatened by an acute problem: Federal funding for cancer research has steadily eroded over the past decade, and only 15% of the ever-shrinking budget is actually spent on clinical trials. This dismal reality threatens the pace of progress against cancer and undermines our ability to address the continuing needs of our patients. Despite this

NASPGHAN Capsule Endoscopy Clinical Report.

PubMed

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.

Refining the structure and content of clinical genomic reports.

PubMed

Dorschner, Michael O; Amendola, Laura M; Shirts, Brian H; Kiedrowski, Lesli; Salama, Joseph; Gordon, Adam S; Fullerton, Stephanie M; Tarczy-Hornoch, Peter; Byers, Peter H; Jarvik, Gail P

2014-03-01

To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. © 2014 Wiley Periodicals, Inc.

Refining the Structure and Content of Clinical Genomic Reports

PubMed Central

DORSCHNER, MICHAEL O.; AMENDOLA, LAURA M.; SHIRTS, BRIAN H.; KIEDROWSKI, LESLI; SALAMA, JOSEPH; GORDON, ADAM S.; FULLERTON, STEPHANIE M.; TARCZY-HORNOCH, PETER; BYERS, PETER H.; JARVIK, GAIL P.

2014-01-01

To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. PMID:24616401

75 FR 28059 - Actual Effects of the Free Trade Agreements With Chile, Australia, and Singapore

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-19

... INTERNATIONAL TRADE COMMISSION [Investigation No. 332-515] Actual Effects of the Free Trade.... International Trade Commission (Commission) instituted investigation No. 332-515, Actual Effects of the Free... effects of the free trade agreements (FTAs) concluded with Chile, Singapore, and Australia. In its report...

The CARE guidelines: consensus-based clinical case reporting guideline development

PubMed Central

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

2013-01-01

A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. PMID:24155002

Outcome when adrenaline (epinephrine) was actually given vs. not given - post hoc analysis of a randomized clinical trial.

PubMed

Olasveengen, Theresa M; Wik, Lars; Sunde, Kjetil; Steen, Petter A

2012-03-01

IV line insertion and drugs did not affect long-term survival in an out-of-hospital cardiac arrest (OHCA) randomized clinical trial (RCT). In a previous large registry study adrenaline was negatively associated with survival from OHCA. The present post hoc analysis on the RCT data compares outcomes for patients actually receiving adrenaline to those not receiving adrenaline. Patients from a RCT performed May 2003 to April 2008 were included. Three patients from the original intention-to-treat analysis were excluded due to insufficient documentation of adrenaline administration. Quality of cardiopulmonary resuscitation (CPR) and clinical outcomes were compared. Clinical characteristics were similar and CPR quality comparable and within guideline recommendations for 367 patients receiving adrenaline and 481 patients not receiving adrenaline. Odds ratio (OR) for being admitted to hospital, being discharged from hospital and surviving with favourable neurological outcome for the adrenaline vs. no-adrenaline group was 2.5 (CI 1.9, 3.4), 0.5 (CI 0.3, 0.8) and 0.4 (CI 0.2, 0.7), respectively. Ventricular fibrillation, response interval, witnessed arrest, gender, age and endotracheal intubation were confounders in multivariate logistic regression analysis. OR for survival for adrenaline vs. no-adrenaline adjusted for confounders was 0.52 (95% CI: 0.29, 0.92). Receiving adrenaline was associated with improved short-term survival, but decreased survival to hospital discharge and survival with favourable neurological outcome after OHCA. This post hoc survival analysis is in contrast to the previous intention-to-treat analysis of the same data, but agrees with previous non-randomized registry data. This shows limitations of non-randomized or non-intention-to-treat analyses. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Flexible Reporting of Clinical Data

PubMed Central

Andrews, Robert D.

1987-01-01

Two prototype methods have been developed to aid in the presentation of relevant clinical data: 1) an integrated report that displays results from a patient's computer-stored data and also allows manual entry of data, and 2) a graph program that plots results of multiple kinds of tests. These reports provide a flexible means of displaying data to help evaluate patient treatment. The two methods also explore ways of integrating the display of data from multiple components of the Veterans Administration's (VA) Decentralized Hospital Computer Program (DHCP) database.

Examining perceived and actual diabetes knowledge among nurses working in a tertiary hospital.

PubMed

Alotaibi, Abdulellah; Gholizadeh, Leila; Al-Ganmi, Ali; Perry, Lin

2017-06-01

With the worldwide increase in the incidence and prevalence of diabetes, there has been an increase in the scope and scale of nursing care and education required for patients with diabetes. The high prevalence of diabetes in Saudi Arabia makes this a particular priority for this country. The aim of this study was to examine nurses' perceived and actual knowledge of diabetes and its care and management in Saudi Arabia. A convenience sample of 423 nurses working in Prince Sultan Medical Military City in Saudi Arabia was surveyed in this descriptive, cross-sectional study. Perceived knowledge was assessed using the Diabetes Self-Report Tool, while the Diabetes Basic Knowledge Tool was used to assess the actual knowledge of participants. The nurses generally had a positive view of their diabetes knowledge, with a mean score (SD) of 46.9 (6.1) (of maximum 60) for the Diabetes Self-Report Tool. Their actual knowledge scores ranged from 2 to 35 with a mean (SD) score of 25.4 (6.2) (of maximum of 49). Nurses' perceived and actual knowledge of diabetes varied according to their demographic and practice details. Perceived competency, current provision of diabetes care, education level and attendance at any diabetes education programs predicted perceived knowledge; these factors, with gender predicted, with actual diabetes knowledge scores. In this multi-ethnic workforce, findings indicated a significant gap between participants' perceived and actual knowledge. Factors predictive of high levels of knowledge provide pointers to ways to improve diabetes knowledge amongst nurses. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Small Increase of Actual Physical Activity 6 Months After Total Hip or Knee Arthroplasty

PubMed Central

Bussmann, Hans J.; Stam, Henk J.; Verhaar, Jan A.

2008-01-01

Limitation in daily physical activity is one of the reasons for total hip arthroplasty (THA) or total knee arthroplasty (TKA). However, studies of the effects of THA or TKA generally do not determine actual daily activity as part of physical functioning. We determined the effect of THA or TKA on patients’ actual physical activity and body function (pain, stiffness), capacity to perform tasks, and self-reported physical functioning. We also assessed whether there are differences in the effect of the surgery between patients undergoing THA or TKA and whether the improvements vary between these different outcome measures. We recruited patients with long-standing end-stage osteoarthritis of the hip or knee awaiting THA or TKA. Measurements were performed before surgery and 3 and 6 months after surgery. Actual physical activity improved by 0.7%. Patients’ body function, capacity, and self-reported physical functioning also improved. The effects of the surgery on these aspects of physical functioning were similar for THA and TKA. The effect on actual physical activity (8%) was smaller than on body function (80%–167%), capacity (19%–36%), and self-reported physical functioning (87%–112%). Therefore, in contrast to the large effect on pain and stiffness, patients’ capacity, and their self-reported physical functioning, the improvement in actual physical activity of our patients was less than expected 6 months after surgery. Level of Evidence: Level I, prospective study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18506555

Persistence with treatment for hypertension in actual practice

PubMed Central

Caro, J J; Salas, M; Speckman, J L; Raggio, G; Jackson, J D

1999-01-01

BACKGROUND: Despite the existence of efficacious medications, many patients in actual practice remain with uncontrolled hypertension. Randomized clinical trials, cannot address this issue well given their highly restricted environment. This paper examines persistence with antihypertensive therapy among patients in actual practice. METHODS: Cohort study of patients who received a diagnosis of hypertension and were treated between 1989 and 1994 identified through the Saskatchewan Health databases. Patients with concurrent diagnoses likely to affect initial treatment choice were excluded. The resulting population of 79,591 subjects was grouped into those with established hypertension (52,227 [66%]) and those with newly diagnosed hypertension (27,364 [34%]). The initial antihypertensive prescription, subsequent changes in treatment and persistence with antihypertensive therapy were analysed. RESULTS: Persistence with antihypertensive therapy decreased in the first 6 months after treatment was started and continued to decline over the next 4 years. Of the patients with newly diagnosed hypertension, only 78% persisted with therapy at the end of 1 year, as compared with 97% of the patients with established hypertension (p < 0.001). Among those with newly diagnosed hypertension, older patients were more likely than younger ones to persist, and women were more likely than men to persist (p < 0.001). INTERPRETATION: This analysis of actual practice data indicates that barriers to persistence occur early in the therapeutic course and that achieving successful therapy when treatment is started is important to maintaining long-term persistence. PMID:9934341

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

PubMed

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

2016-10-01

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 reported being in high school were provided a list of services and asked whether they had gone to a school nurse or clinic for any of the listed services. Nearly 90% reported having access to a school clinic or nurse. Among students with access, 65.6% reported using at least one service. Non-White students and younger students were more likely to report having access to a clinic or nurse. These results show many students have access to clinics or nurses and are using these services, although not uniformly for all services. © The Author(s) 2016.

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

PubMed

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

2014-01-01

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

Minorities and Clinical Trials: Patients, Physicians, Clinical Trial Characteristics and their Environment

DTIC Science & Technology

2012-07-01

sites to assess their discussions with physicians, intentions and actual participation in prostate cancer clinical trials, attitudes and knowledge about...with physicians, intentions and actual participation in prostate cancer clinical trials, attitudes and knowledge about such trials, and barriers to and...calculated and compared across race/ethnicity. Examination of major outcomes included willingness to participate in, knowledge of, and attitudes towards

Assessment of the actual light dose in photodynamic therapy.

PubMed

Schaberle, Fabio A

2018-06-09

Photodynamic therapy (PDT) initiates with the absorption of light, which depends on the spectral overlap between the light source emission and the photosensitizer absorption, resulting in the number of photons absorbed, the key parameter starting PDT processes. Most papers report light doses regardless if the light is only partially absorbed or shifted relatively to the absorption peak, misleading the actual light dose value and not allowing quantitative comparisons between photosensitizers and light sources. In this manuscript a method is presented to calculate the actual light dose delivered by any light source for a given photosensitizer. This method allows comparing light doses delivered for any combination of light source (broad or narrow band or daylight) and photosensitizer. Copyright © 2018. Published by Elsevier B.V.

7 CFR 1437.101 - Actual production history.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false Actual production history. 1437.101 Section 1437.101... Determining Yield Coverage Using Actual Production History § 1437.101 Actual production history. Actual production history (APH) is the unit's record of crop yield by crop year for the APH base period. The APH...

7 CFR 1437.101 - Actual production history.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false Actual production history. 1437.101 Section 1437.101... Determining Yield Coverage Using Actual Production History § 1437.101 Actual production history. Actual production history (APH) is the unit's record of crop yield by crop year for the APH base period. The APH...

7 CFR 1437.101 - Actual production history.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false Actual production history. 1437.101 Section 1437.101... Determining Yield Coverage Using Actual Production History § 1437.101 Actual production history. Actual production history (APH) is the unit's record of crop yield by crop year for the APH base period. The APH...

7 CFR 1437.101 - Actual production history.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false Actual production history. 1437.101 Section 1437.101... Determining Yield Coverage Using Actual Production History § 1437.101 Actual production history. Actual production history (APH) is the unit's record of crop yield by crop year for the APH base period. The APH...

7 CFR 1437.101 - Actual production history.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false Actual production history. 1437.101 Section 1437.101... Determining Yield Coverage Using Actual Production History § 1437.101 Actual production history. Actual production history (APH) is the unit's record of crop yield by crop year for the APH base period. The APH...

Electronic clinical safety reporting system: a benefits evaluation.

PubMed

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

Clinical Preceptor.

ERIC Educational Resources Information Center

Gardipee, Sheila; Clemens, Glenna

A clinical preceptor is an employed registered nurse in a clinical facility who supervises and evaluates a student's performance independent of a clinical instructor. This manual is intended to assist the clinical preceptor, especially the preceptor dealing with re-entry nursing students. It encompasses a practical approach with actual situations…

The District Nursing Clinical Error Reduction Programme.

PubMed

McGraw, Caroline; Topping, Claire

2011-01-01

The District Nursing Clinical Error Reduction (DANCER) Programme was initiated in NHS Islington following an increase in the number of reported medication errors. The objectives were to reduce the actual degree of harm and the potential risk of harm associated with medication errors and to maintain the existing positive reporting culture, while robustly addressing performance issues. One hundred medication errors reported in 2007/08 were analysed using a framework that specifies the factors that predispose to adverse medication events in domiciliary care. Various contributory factors were identified and interventions were subsequently developed to address poor drug calculation and medication problem-solving skills and incorrectly transcribed medication administration record charts. Follow up data were obtained at 12 months and two years. The evaluation has shown that although medication errors do still occur, the programme has resulted in a marked shift towards a reduction in the associated actual degree of harm and the potential risk of harm.

Comparing Perceptions with Actual Reports of Close Friend’s HIV Testing Behavior Among Urban Tanzanian Men

PubMed Central

Yamanis, Thespina J.; Balvanz, Peter; Kajula, Lusajo J.; Maman, Suzanne

2016-01-01

Men have lower rates of HIV testing and higher rates of AIDS-related mortality compared to women in sub-Saharan Africa. To assess whether there is an opportunity to increase men’s uptake of testing by correcting misperceptions about testing norms, we compare men’s perceptions of their closest friend’s HIV testing behaviors with the friend’s actual testing self-report using a unique dataset of men sampled within their social networks (n = 59) in Dar es Salaam, Tanzania. We examine the accuracy and bias of perceptions among men who have tested for HIV (n = 391) and compare them to the perceptions among men who never tested (n = 432). We found that testers and non-testers did not differ in the accuracy of their perceptions, though non-testers were strongly biased towards assuming that their closest friends had not tested. Our results lend support to social norms approaches designed to correct the biased misperceptions of non-testers to promote men’s HIV testing. PMID:26880322

Teamwork and clinical error reporting among nurses in Korean hospitals.

PubMed

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.

False memories, negative affects, and psychic reality: the role of extra-clinical data in psychoanalysis.

PubMed

Good, Michael I; Dayand, Max; Rowell, Eve

2005-12-01

Psychoanalysis as a treatment originated in the idea that neurosis is related to the ways in which individual psychic reality departs from actuality. Psychic reality includes memories, beliefs and their associated affects and fantasies connected with an individual's experience of the inner and outer world. The psychoanalytic determination of what meaningful memories or beliefs are inaccurate, distorted or false ordinarily relies upon principles of intra-clinical validation. By itself, however, intra-clinical validation is subject to limitations and pitfalls that conviction alone about what is actual cannot circumvent. Despite this fact, there are remarkably few analytic case reports demonstrating false or significantly distorted memories through the use of data obtained from outside the consulting room. This paucity of reports may be related, at least in part, to the belief that the use of extra-clinical data is essentially unanalytic or supports resistance. Based on the views that (a) psychic reality cannot be regarded as exclusively subjective or objective but is inherently both; and that (b) a goal of analysis is to achieve a different, acceptable and more accurate view of reality, the authors report a clinical case involving a confirmably false pivotal memory and its associated negative affects. They discuss theoretical and technical considerations in utilizing extra-clinical data during the treatment process.

Validation of the Clinical Learning Environment Inventory.

PubMed

Chan, Dominic S

2003-08-01

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

OARSI Clinical Trials Recommendations: Design, conduct, and reporting of clinical trials for knee osteoarthritis.

PubMed

McAlindon, T E; Driban, J B; Henrotin, Y; Hunter, D J; Jiang, G-L; Skou, S T; Wang, S; Schnitzer, T

2015-05-01

The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Automatic classification of radiological reports for clinical care.

PubMed

Gerevini, Alfonso Emilio; Lavelli, Alberto; Maffi, Alessandro; Maroldi, Roberto; Minard, Anne-Lyse; Serina, Ivan; Squassina, Guido

2018-06-07

Radiological reporting generates a large amount of free-text clinical narratives, a potentially valuable source of information for improving clinical care and supporting research. The use of automatic techniques to analyze such reports is necessary to make their content effectively available to radiologists in an aggregated form. In this paper we focus on the classification of chest computed tomography reports according to a classification schema proposed for this task by radiologists of the Italian hospital ASST Spedali Civili di Brescia. The proposed system is built exploiting a training data set containing reports annotated by radiologists. Each report is classified according to the schema developed by radiologists and textual evidences are marked in the report. The annotations are then used to train different machine learning based classifiers. We present in this paper a method based on a cascade of classifiers which make use of a set of syntactic and semantic features. The resulting system is a novel hierarchical classification system for the given task, that we have experimentally evaluated. Copyright © 2018 Elsevier B.V. All rights reserved.

Effect of neurolinguistic programming training on self-actualization as measured by the Personal Orientation Inventory.

PubMed

Duncan, R C; Konefal, J; Spechler, M M

1990-06-01

Neurolinguistic programming training is based on principles that should enable the trainee to be more "present"-oriented, inner-directed, flexible, self-aware, and responsive to others, that is, more self-actualized. This study reports within-person changes on self-actualization measures of the Personal Orientation Inventory following a 24-day residential training in neurolinguistic programming. Significant positive mean changes were found for 18 master practitioners on nine of the 12 scales and for 36 practitioners on 10 of the 12 scales. Findings are consistent with the hypothesis that training increases individual self-actualization scores.

The STAR Data Reporting Guidelines for Clinical High Altitude Research.

PubMed

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.

Expected satiation alone does not predict actual intake of desserts.

PubMed

Guillocheau, Etienne; Davidenko, Olga; Marsset-Baglieri, Agnès; Darcel, Nicolas; Gaudichon, Claire; Tomé, Daniel; Fromentin, Gilles

2018-04-01

The degree to which consumers expect foods to satisfy hunger, referred to as expected satiation, has been reported to predict food intake. Yet this relationship has not been established precisely, at a quantitative level. We sought to explore this relationship in detail by determining whether expected satiation predicts the actual intake of semi-solid desserts. Two separate experiments were performed: the first used variations of a given food (eight apple purées), while the second involved a panel of different foods within a given category (eight desserts). Both experiments studied the consumption of two products assigned to volunteers based on their individual liking and expected satiation ratings, given ad libitum at the end of a standardised meal. A linear model was used to find predictors of food intake and included expected satiation scores, palatability scores, BMI, age, sex, TFEQ-R, TFEQ-D, water consumption during the meal, reported frequency of eating desserts, and reported frequency of consuming tested products as explanatory variables. Expected satiation was a significant predictor of actual food intake in both experiments (apple purée: F(1,97) = 18.60, P < .001; desserts: F(1,106) = 9.05, P < .01), along with other parameters such as product palatability and the volunteers' age, sex and food restriction (variation explained by the model/expected satiation in the experiments: 57%/23% and 36%/17%, respectively). However, we found a significant gap between expected and actual consumption of desserts, on group and on individual level. Our results confirm the importance of expected satiation as a predictor of subsequent food intake, but highlight the need to study individual consumption behaviour and preferences in order to fully understand the role of expected satiation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Special Education Microteaching Clinic: Final Report.

ERIC Educational Resources Information Center

Shea, Thomas M.; And Others

Presented is the final report on the Special Education Microteaching Clinic at Southern Illinois University (Edwardsville) which incorporates a practice teaching technique in which a student teaches a lesson, is critiqued and shown a videotape, then reteaches the lesson. Section I, the overview, includes a presentation of the Microteaching…

Location of colorectal cancer: colonoscopy versus surgery. Yield of colonoscopy in predicting actual location.

PubMed

Blum-Guzman, Juan Pablo; Wanderley de Melo, Silvio

2017-07-01

 Recent studies suggest that differences in biological characteristics and risk factors across cancer site within the colon and rectum may translate to differences in survival. It can be challenging at times to determine the precise anatomical location of a lesion with a luminal view during colonoscopy. The aim of this study is to determine if there is a significant difference between the location of colorectal cancers described by gastroenterologists in colonoscopies and the actual anatomical location noted on operative and pathology reports after colon surgery.  A single-center retrospective analysis of colonoscopies of patient with reported colonic masses from January 2005 to April 2014 (n = 380) was carried. Assessed data included demography, operative and pathology reports. Findings were compared: between the location of colorectal cancers described by gastroenterologists in colonoscopies and the actual anatomical location noted on operative reports or pathology samples.  We identified 380 colonic masses, 158 were confirmed adenocarcinomas. Of these 123 underwent surgical resection, 27 had to be excluded since no specific location was reported on their operative or pathology report. An absolute difference between endoscopic and surgical location was found in 32 cases (33 %). Of these, 22 (23 %) differed by 1 colonic segment, 8 (8 %) differed by 2 colonic segments and 2 (2 %) differed by 3 colonic segments.  There is a significant difference between the location of colorectal cancers reported by gastroenterologists during endoscopy and the actual anatomical location noted on operative or pathology reports after colon surgery. Endoscopic tattooing should be used when faced with any luminal lesions of interest.

Perceived and actual academic competence in maltreated children.

PubMed

Kinard, E M

2001-01-01

The aims were twofold: 1) to determine whether maltreated and nonmaltreated children differed in the accuracy of their self-assessments of academic achievement; and 2) to determine whether discrepancies between perceived and actual academic competence were related to perceptions of social support from mothers, teachers, and peers. A sample of 195 maltreated children known to a state protective service agency was compared to a control group of 179 nonmaltreated children. The groups were matched on child's gender, age, ethnicity, and birth order; socioeconomic ranking of neighborhood; and family structure. Although maltreated children had significantly lower achievement scores than did nonmal-treated children, the two groups did not differ on perceived academic competence. With regard to discrepancies between perceived and actual competence, maltreated children were more likely than nonmaltreated children to overestimate their level of competence, particularly for reading and arithmetic. Overall, children who reported low maternal support were more likely to overestimate reading competence than were those who reported average or high maternal support. When maltreatment status was considered, maltreated children with low support seemed likely to overestimate abilities, whereas nonmaltreated children with low support seemed likely to underestimate competence. Maltreated children may overestimate their academic abilities in order to compensate for self-perceptions of low self-worth. Efforts to improve academic performance in maltreated children should focus not only on increasing academic skills but also on enhancing self-esteem.

Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

PubMed

Hartung, Daniel M; Zarin, Deborah A; Guise, Jeanne-Marie; McDonagh, Marian; Paynter, Robin; Helfand, Mark

2014-04-01

ClinicalTrials.gov requires reporting of result summaries for many drug and device trials. To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature. ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases. 10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups. One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified. Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication. Small sample that included earliest results posted to the database. Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication. Agency for Healthcare Research and Quality.

Adolescent psychological and academic adjustment as a function of discrepancies between actual and ideal self-perceptions.

PubMed

Ferguson, Gail M; Hafen, Christopher A; Laursen, Brett

2010-12-01

Actual-ideal discrepancies are associated with adolescent emotional distress and there is evidence that the size of discrepancies matters. However, the direction of discrepancies has not been examined, perhaps due to limitations of widely used self-discrepancy measures. Two hundred and twelve 7th, 9th and 11th grade students (59% female) in a public school in Jamaica described their actual and ideal selves in several different domains--friendship, dating, schoolwork, family, sports, and religion/spirituality--using a Pie measure. Students also completed measures of depressive symptoms, self-esteem, and academic achievement. Discrepancies favoring the ideal self and those favoring the actual self were linked to depressive symptoms, low self-esteem, and poor school grades in the domains of friendship, dating, and schoolwork. Effects were stronger among older adolescents than among younger adolescents. Theories of actual/ideal self-discrepancies have focused on problems arising when the ideal self overshadows the actual self; however, the present study finds that self-discrepancies, regardless of their direction, are a liability. Implications for self-discrepancy measurement, adolescent development, and clinical practice are discussed.

Are Human Mating Preferences with Respect to Height Reflected in Actual Pairings?

PubMed Central

Stulp, Gert; Buunk, Abraham P.; Pollet, Thomas V.; Nettle, Daniel; Verhulst, Simon

2013-01-01

Pair formation, acquiring a mate to form a reproductive unit, is a complex process. Mating preferences are a step in this process. However, due to constraining factors such as availability of mates, rival competition, and mutual mate choice, preferred characteristics may not be realised in the actual partner. People value height in their partner and we investigated to what extent preferences for height are realised in actual couples. We used data from the Millennium Cohort Study (UK) and compared the distribution of height difference in actual couples to simulations of random mating to test how established mate preferences map on to actual mating patterns. In line with mate preferences, we found evidence for: (i) assortative mating (r = .18), (ii) the male-taller norm, and, for the first time, (iii) for the male-not-too-tall norm. Couples where the male partner was shorter, or over 25 cm taller than the female partner, occurred at lower frequency in actual couples than expected by chance, but the magnitude of these effects was modest. We also investigated another preference rule, namely that short women (and tall men) prefer large height differences with their partner, whereas tall women (and short men) prefer small height differences. These patterns were also observed in our population, although the strengths of these associations were weaker than previously reported strength of preferences. We conclude that while preferences for partner height generally translate into actual pairing, they do so only modestly. PMID:23342102

Are human mating preferences with respect to height reflected in actual pairings?

PubMed

Stulp, Gert; Buunk, Abraham P; Pollet, Thomas V; Nettle, Daniel; Verhulst, Simon

2013-01-01

Pair formation, acquiring a mate to form a reproductive unit, is a complex process. Mating preferences are a step in this process. However, due to constraining factors such as availability of mates, rival competition, and mutual mate choice, preferred characteristics may not be realised in the actual partner. People value height in their partner and we investigated to what extent preferences for height are realised in actual couples. We used data from the Millennium Cohort Study (UK) and compared the distribution of height difference in actual couples to simulations of random mating to test how established mate preferences map on to actual mating patterns. In line with mate preferences, we found evidence for: (i) assortative mating (r = .18), (ii) the male-taller norm, and, for the first time, (iii) for the male-not-too-tall norm. Couples where the male partner was shorter, or over 25 cm taller than the female partner, occurred at lower frequency in actual couples than expected by chance, but the magnitude of these effects was modest. We also investigated another preference rule, namely that short women (and tall men) prefer large height differences with their partner, whereas tall women (and short men) prefer small height differences. These patterns were also observed in our population, although the strengths of these associations were weaker than previously reported strength of preferences. We conclude that while preferences for partner height generally translate into actual pairing, they do so only modestly.

Prospective analysis of factors associated with inadequate bowel preparation for colonoscopy in actual clinical practice

PubMed Central

Woo, Dae Hyung; Jeong, Da Eun; Nam, Yoon Jeong; Lee, Si Hyung; Jang, Byung Ik; Kim, Tae Nyeun

2018-01-01

Background/Aims Inadequate bowel preparation can result in prolonged procedure time and increased missed lesion and complication rates. This prospective study aimed to evaluate bowel preparation quality and identify the predictive factors for inadequate bowel preparation in actual clinical practice. Methods We included 399 patients who underwent colonoscopy between June 2015 and July 2016. Using the Aronchick bowel preparation scale, we defined a score ≤2 as adequate preparation and a score >2 as inadequate preparation. Results Mean patient age was 58.38±12.97 years; 60.6% were male. Indications for colonoscopy included screening (69.7%) and surveillance after polyp removal (21.3%). A split-dose regimen was prescribed to 55.4% of patients. The inadequate bowel preparation rate was 28.1%. Overall, the median time between the last bowel preparation agent dose and start of colonoscopy was 5.0 hours (range, 1.5–16.0 hours); that of the adequate group was 5.0 hours (range, 1.5–16.0 hours); and that of the inadequate group was 5 hours (range, 2–23 hours). The mean bowel preparation scale score of the ascending colon (1.94±0.25) was significantly higher than that of other colon segments. On multivariate analysis, elderly age, history of cerebrovascular disease, history of gastrectomy or appendectomy, and total preparation solution uptake <2 L were the independent predictors of inadequate bowel preparation. Conclusions The inadequate bowel preparation rate was 28.1%. Risk factors included elderly age and history of cerebrovascular disease or abdominal surgery. Patients with these risk factors require special care and education. PMID:29743843

Quality Management Tools: Facilitating Clinical Research Data Integrity by Utilizing Specialized Reports with Electronic Case Report Forms

PubMed Central

Trocky, NM; Fontinha, M

2005-01-01

Data collected throughout the course of a clinical research trial must be reviewed for accuracy and completeness continually. The Oracle Clinical® (OC) data management application utilized to capture clinical data facilitates data integrity through pre-programmed validations, edit and range checks, and discrepancy management modules. These functions were not enough. Coupled with the use of specially created reports in Oracle Discoverer® and Integrated Review TM, both ad-hoc query and reporting tools, research staff have enhanced their ability to clean, analyze and report more accurate data captured within and among Case Report Forms (eCRFs) by individual study or across multiple studies. PMID:16779428

Perceived and Actual Behavior in Female Sexual Assertiveness: A Within-Couple Analysis in Hong Kong.

PubMed

Zhang, Huiping; Yip, Paul S F

2018-01-02

Studies in female sexual assertiveness have generally focused on individuals rather than couples, and little research has been conducted in the Chinese context. This study examined perceived and actual female sexual assertiveness at the couple level, and also explored its impact on marital and sexual satisfaction with a representative sample of 770 couples in Hong Kong. The results showed that husbands reported a higher level of acceptance of female sexual assertiveness in both perception and actual behavior; furthermore, couples reported greater congruence in their perception of female sexual initiation than actual behavior. Multiple logistic regressions showed that actual female sexual assertiveness, not the perception of it, affects both spouses' marital and sexual satisfaction. Compared with couples in which neither accepted female sexual initiation in practice, husbands where both spouses accepted this were more likely to be satisfied with the marriage. Husbands who accepted female sexual refusal whilst their wives did not were also more likely to be satisfied with both the marital and sexual relationship. Similarly, wives who did accept female sexual assertiveness but whose husbands did not were more likely to be satisfied with both the marital and sexual relationship.

Automated Reporting of Trainee Metrics Using Electronic Clinical Systems.

PubMed

Levin, Jonathan C; Hron, Jonathan

2017-06-01

The Accreditation Council for Graduate Medical Education has called for increased emphasis on reporting objective performance measures to trainees and programs. However, reporting of objective measures, including clinical volume, is largely omitted from training programs. To use automated electronic medical systems at a tertiary pediatric care hospital to create a dashboard that reports objective trainee and program metrics, including clinical volume and diagnoses in a pediatrics residency. We queried an enterprise data warehouse that aggregates data daily from multiple hospital systems to identify patient encounters during which senior pediatrics residents at Boston Children's Hospital had entered documentation over a 9-month period. From this query, we created a filterable dashboard to display clinical volume and diagnosis data by individual resident and in aggregate. A total of 44 of 45 senior residents (98%) in the program were included in analysis. We identified 12 198 patient encounters during which a senior pediatrics resident had entered documentation; these included a median of 332 inpatient encounters per resident, 122 emergency department encounters, and 84 outpatient encounters. The most common diagnoses stratified by clinical site were: inpatient - dehydration (median = 61); emergency department - long-term/current drug therapy (median = 16); and outpatient - encounter for immunization (median = 48). We used electronic health record systems to generate performance dashboards for trainees in a pediatrics residency across different sites of care with reported volume by diagnosis. Our dashboards provide feedback to program leadership regarding individual and aggregate trainee experience and allow individual trainees to compare their clinical exposure to peers.

Preferences and actual chemotherapy decision-making in the greater plains collaborative breast cancer study.

PubMed

Berger, Ann M; Buzalko, Russell J; Kupzyk, Kevin A; Gardner, Bret J; Djalilova, Dilorom M; Otte, Julie L

2017-12-01

There is renewed interest in identifying breast cancer patients' participation in decision-making about adjuvant chemotherapy. There is a gap in the literature regarding the impact of these decisions on quality of life (QOL) and quality of care (QOC). Our aims were to determine similarities and differences in how patients diagnosed with breast cancer preferred to make decisions with providers about cancer treatment, to examine the patient's recall of her role when the decision was made about chemotherapy and to determine how preferred and actual roles, as well as congruence between them, relate to QOL and perceived QOC. Greater Plains Collaborative clinical data research network of PCORnet conducted the 'Share Thoughts on Breast Cancer' survey among women 12-18 months post-diagnosis at eight sites in seven Midwestern United States. Patients recalled their preferred and actual treatment decision-making roles and three new shared decision-making (SDM) variables were created. Patients completed QOL and QOC measurements. Correlations and t-tests were used. Of 1235 returned surveys, 873 (full sample) and 329 (subsample who received chemotherapy) were used. About one-half of women in both the full (50.7%) and subsample (49.8%,) preferred SDM with providers about treatment decisions, but only 41.2% (full) and 42.6% (subsample) reported experiencing SDM. Significant differences were found between preferred versus actual roles in the full (p < .001) and subsample (p < .004). In the full sample, there were no relationships between five decision-making variables with QOL, but there was an association with QOC. The subsample's decision-making variables related to several QOL scales and QOC items, with a more patient-centered decision than originally preferred related to higher physical and social/family well-being, overall QOL and QOC. Patients benefit from providers' efforts to identify patient preferences, encourage an active role in SDM, and tailor decision making

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

PubMed Central

Vickers, Michael M.; O’Connor, Stephen; Valdes, Mario; Tang, Patricia A.

2016-01-01

Introduction. 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. Materials and Methods. 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. Results. 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. Conclusion. 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

Reliability of clinical diagnosis and laboratory testing techniques currently used for identification of canine parvovirus enteritis in clinical settings

PubMed Central

FAZ, Mirna; MARTÍNEZ, José Simón; QUIJANO-HERNÁNDEZ, Israel; FAJARDO, Raúl

2016-01-01

Canine parvovirus type 2 (CPV-2) is the main etiological agent of viral enteritis in dogs. Actually in literature, CPV-2 has been reported with clinical signs that vary from the classical disease, and immunochromatography test and PCR technique have been introduced to veterinary hospitals to confirm CPV-2 diagnosis and other infections. However, the reliability of these techniques has been poorly analyzed. In this study, we evaluated the sensitivity and specificity of veterinary clinical diagnosis, immunochromatography test and PCR technique. Our data indicate that variations in the clinical signs of CPV-2 complicate the gathering of an appropriate diagnosis; and immunochromatography test and PCR technique do not have adequate sensitivity to diagnose positive cases. PMID:27818461

Providing Clinicians and Patients With Actual Prognosis: Cancer in the Context of Competing Causes of Death

PubMed Central

Mariotto, Angela B.; Woloshin, Steven; Schwartz, Lisa M.

2014-01-01

Background To isolate progress against cancer from changes in competing causes of death, population cancer registries have traditionally reported cancer prognosis (net measures). But clinicians and cancer patients generally want to understand actual prognosis (crude measures): the chance of surviving, dying from the specific cancer and from competing causes of death in a given time period. Objective To compare cancer and actual prognosis in the United States for four leading cancers—lung, breast, prostate, and colon—by age, comorbidity, and cancer stage and to provide templates to help patients, clinicians, and researchers understand actual prognosis. Method Using population-based registry data from the Surveillance, Epidemiology, and End Results (SEER) Program, we calculated cancer prognosis (relative survival) and actual prognosis (five-year overall survival and the “crude” probability of dying from cancer and competing causes) for three important prognostic determinants (age, comorbidity [Charlson-score from 2012 SEER-Medicare linkage dataset] and cancer stage at diagnosis). Result For younger, healthier, and earlier stage cancer patients, cancer and actual prognosis estimates were quite similar. For older and sicker patients, these prognosis estimates differed substantially. For example, the five-year overall survival for an 85-year-old patient with colorectal cancer is 54% (cancer prognosis) versus 22% (actual prognosis)—the difference reflecting the patient’s substantial chance of dying from competing causes. The corresponding five-year chances of dying from the patient’s cancer are 46% versus 37%. Although age and comorbidity lowered actual prognosis, stage at diagnosis was the most powerful factor: The five-year chance of colon cancer death was 10% for localized stage and 83% for distant stage. Conclusion Both cancer and actual prognosis measures are important. Cancer registries should routinely report both cancer and actual prognosis to help

Providing clinicians and patients with actual prognosis: cancer in the context of competing causes of death.

PubMed

Howlader, Nadia; Mariotto, Angela B; Woloshin, Steven; Schwartz, Lisa M

2014-11-01

To isolate progress against cancer from changes in competing causes of death, population cancer registries have traditionally reported cancer prognosis (net measures). But clinicians and cancer patients generally want to understand actual prognosis (crude measures): the chance of surviving, dying from the specific cancer and from competing causes of death in a given time period. To compare cancer and actual prognosis in the United States for four leading cancers-lung, breast, prostate, and colon-by age, comorbidity, and cancer stage and to provide templates to help patients, clinicians, and researchers understand actual prognosis. Using population-based registry data from the Surveillance, Epidemiology, and End Results (SEER) Program, we calculated cancer prognosis (relative survival) and actual prognosis (five-year overall survival and the "crude" probability of dying from cancer and competing causes) for three important prognostic determinants (age, comorbidity [Charlson-score from 2012 SEER-Medicare linkage dataset] and cancer stage at diagnosis). For younger, healthier, and earlier stage cancer patients, cancer and actual prognosis estimates were quite similar. For older and sicker patients, these prognosis estimates differed substantially. For example, the five-year overall survival for an 85-year-old patient with colorectal cancer is 54% (cancer prognosis) versus 22% (actual prognosis)-the difference reflecting the patient's substantial chance of dying from competing causes. The corresponding five-year chances of dying from the patient's cancer are 46% versus 37%. Although age and comorbidity lowered actual prognosis, stage at diagnosis was the most powerful factor: The five-year chance of colon cancer death was 10% for localized stage and 83% for distant stage. Both cancer and actual prognosis measures are important. Cancer registries should routinely report both cancer and actual prognosis to help clinicians and researchers understand the difference between

Reporting Items for Updated Clinical Guidelines: Checklist for the Reporting of Updated Guidelines (CheckUp)

PubMed Central

Vernooij, Robin W. M.; Alonso-Coello, Pablo; Brouwers, Melissa

2017-01-01

Background Scientific knowledge is in constant development. Consequently, regular review to assure the trustworthiness of clinical guidelines is required. However, there is still a lack of preferred reporting items of the updating process in updated clinical guidelines. The present article describes the development process of the Checklist for the Reporting of Updated Guidelines (CheckUp). Methods and Findings We developed an initial list of items based on an overview of research evidence on clinical guideline updating, the Appraisal of Guidelines for Research and Evaluation (AGREE) II Instrument, and the advice of the CheckUp panel (n = 33 professionals). A multistep process was used to refine this list, including an assessment of ten existing updated clinical guidelines, interviews with key informants (response rate: 54.2%; 13/24), a three-round Delphi consensus survey with the CheckUp panel (33 participants), and an external review with clinical guideline methodologists (response rate: 90%; 53/59) and users (response rate: 55.6%; 10/18). CheckUp includes 16 items that address (1) the presentation of an updated guideline, (2) editorial independence, and (3) the methodology of the updating process. In this article, we present the methodology to develop CheckUp and include as a supplementary file an explanation and elaboration document. Conclusions CheckUp can be used to evaluate the completeness of reporting in updated guidelines and as a tool to inform guideline developers about reporting requirements. Editors may request its completion from guideline authors when submitting updated guidelines for publication. Adherence to CheckUp will likely enhance the comprehensiveness and transparency of clinical guideline updating for the benefit of patients and the public, health care professionals, and other relevant stakeholders. PMID:28072838

Developing of method for primary frequency control droop and deadband actual values estimation

NASA Astrophysics Data System (ADS)

Nikiforov, A. A.; Chaplin, A. G.

2017-11-01

Operation of thermal power plant generation equipment, which participates in standardized primary frequency control (SPFC), must meet specific requirements. These requirements are formalized as nine algorithmic criteria, which are used for automatic monitoring of power plant participation in SPFC. One of these criteria - primary frequency control droop and deadband actual values estimation is considered in detail in this report. Experience shows that existing estimation method sometimes doesn’t work properly. Author offers alternative method, which allows estimating droop and deadband actual values more accurately. This method was implemented as a software application.

Can eyewitnesses correct for external influences on their lineup identifications? The actual/counterfactual assessment paradigm.

PubMed

Charman, Steve D; Wells, Gary L

2008-03-01

Real-world eyewitnesses are often asked whether their lineup responses were affected by various external influences, but it is unknown whether they can accurately answer these types of questions. The witness-report-of-influence mental-correction model is proposed to explain witnesses' reports of influence. Two experiments used a new paradigm (the actual/counterfactual paradigm) to examine eyewitnesses' abilities to report accurately on the influence of lineup manipulations. Eyewitnesses were administered either confirming feedback or no feedback (Experiment 1, n = 103), or a cautionary instruction or no cautionary instruction (Experiment 2, n = 114). Eyewitnesses then gave actual responses (retrospective confidence, view, and attention measures in Experiment 1; identification decision in Experiment 2) as well as counterfactual responses stating how they would have responded in the alternative condition. Results across both studies showed an asymmetric estimation of influence pattern: Eyewitnesses who received an influencing manipulation estimated significantly less of a change in their responses than eyewitnesses who did not receive an influencing manipulation. A 48-hr delay between actual and counterfactual responses did not moderate any effects. Results are explained by witnesses' implicit theories of influence. PsycINFO Database Record (c) 2008 APA, all rights reserved

The discrepancy between emotional vs. rational estimates of body size, actual size, and ideal body ratings: theoretical and clinical implications.

PubMed

Thompson, J K; Dolce, J J

1989-05-01

Thirty-two asymptomatic college females were assessed on multiple aspects of body image. Subjects' estimation of the size of three body sites (waist, hips, thighs) was affected by instructional protocol. Emotional ratings, based on how they "felt" about their body, elicited ratings that were larger than actual and ideal size measures. Size ratings based on rational instructions were no different from actual sizes, but were larger than ideal ratings. There were no differences between actual and ideal sizes. The results are discussed with regard to methodological issues involved in body image research. In addition, a working hypothesis that differentiates affective/emotional from cognitive/rational aspects of body size estimation is offered to complement current theories of body image. Implications of the findings for the understanding of body image and its relationship to eating disorders are discussed.

Sci-Fri AM: Quality, Safety, and Professional Issues 06: An Evaluation of Incident Reporting and Learning using the Canadian National System for Incident Reporting – Radiation Treatment

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

Montgomery, Logan; Kildea, John

We report on the development and clinical deployment of an in-house incident reporting and learning system that implements the taxonomy of the Canadian National System for Incident Reporting – Radiation Treatment (NSIR-RT). In producing our new system, we aimed to: Analyze actual incidents, as well as potentially dangerous latent conditions. Produce recommendations on the NSIR-RT taxonomy. Incorporate features to divide reporting responsibility among clinical staff and expedite incident categorization within the NSIR-RT framework. Share anonymized incident data with the national database. Our multistep incident reporting workflow is focused around an initial report and a detailed follow-up investigation. An investigator, chosenmore » at the time of reporting, is tasked with performing the investigation. The investigation feature is connected to our electronic medical records database to allow automatic field population and quick reference of patient and treatment information. Additional features include a robust visualization suite, as well as the ability to flag incidents for discussion at monthly Risk Management meetings and task ameliorating actions to staff. Our system was deployed into clinical use in January 2016. Over the first three months of use, 45 valid incidents were reported; 31 of which were reported as actual incidents as opposed to near-misses or reportable circumstances. However, we suspect there is ambiguity within our centre in determining the appropriate event type, which may be arising from the taxonomy itself. Preliminary trending analysis aided in revealing workflow issues pertaining to storage of treatment accessories and treatment planning delays. Extensive analysis will be undertaken as more data are accrued.« less

Major clinical events, signs and severity assessment scores related to actual survival in patients who died from primary biliary cirrhosis. A long-term historical cohort study.

PubMed

van Dam, G M; Gips, C H; Reisman, Y; Maas, K W; Purmer, I M; Huizenga, J R; Verbaan, B W

1999-01-01

One of the prognostic methods for survival in primary biliary cirrhosis (PBC) is the Mayo model, with a time-scale limited to 7 years. The aim of our study was to assess how major clinical events, signs, several severity assessment methods and Mayo survival probabilities fit in with actual patient survival, by using yearly observations until 0.5 years before patient death from PBC. Data of 32 patients dying from PBC were collected prior to death at -0.5, -1, -2 etc. years (median: -5 years, range: -16 to -0.5 years). Major events registered were: first occurrence of ascites, upper gastrointestinal bleeding or manifest hepatic encephalopathy and signs, first observation of spider naevi or purpura. Severity assessment methods applied (all with scores and classes) were: Mayo (M), Child-Campbell (C), Pugh-Child (P), Pugh-Child-PBC (PP), 'Child-Pugh' (CP), and Ascites Nutritional State-Child (ANS). Fifty percent survival estimates were calculated from Mayo scores. Severity assessment method variables were: ascites (C, P, PP, CP, ANS), encephalopathy (C, P, PP, CP), nutritional state (C, ANS), edema (M), age (M), serum albumin (M, C, P, PP, CP), bilirubin (C, M, P, PP, CP), and prothrombin time (M, P, PP, CP). In 27 out of 32 patients a major event occurred, always between -6 and -0.5 years (median: -1 year) and, never between -16 and -7 years (p < 0.0001). A sign was first observed in 30/32 between -14 and -0.5 years (median: -2 years). Compared to the total population, a sign, and even more so, an event indicated a shorter survival (p = 0.004 and p = 0.0002, respectively). The median 50% estimated survival (predicted by the Mayo model) fitted the actual survival from -6 to -0.5 years (r = -0.7, p < 0.0001), but not from -16 to -7 years (r = -0.1, p = 0.4). All -6 to -0.5-year severity scores correlated (p < 0.0001) both with actual survival (M, C, P, PP, and CP r = 0.7; ANS r = 0.5) and with estimated M 50% survival (C, P, PP, CP r = -0.9; ANS r = -0.6; M score: -0

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study.

PubMed

Earley, Amy; Lau, Joseph; Uhlig, Katrin

2013-01-18

A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Registry-based study of clinical trial results reporting. ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications.

Visual Acuity Reporting in Clinical Research Publications.

PubMed

Tsou, Brittany C; Bressler, Neil M

2017-06-01

Visual acuity results in publications typically are reported in Snellen or non-Snellen formats or both. A study in 2011 suggested that many ophthalmologists do not understand non-Snellen formats, such as logarithm of the Minimum Angle of Resolution (logMAR) or Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores. As a result, some journals, since at least 2013, have instructed authors to provide approximate Snellen equivalents next to non-Snellen visual acuity values. To evaluate how authors currently report visual acuity and whether they provide Snellen equivalents when their reports include non-Snellen formats. From November 21, 2016, through December 14, 2016, one reviewer evaluated visual acuity reporting among all articles published in 4 ophthalmology clinical journals from November 2015 through October 2016, including 3 of 4 journals that instructed authors to provide Snellen equivalents for visual acuity reported in non-Snellen formats. Frequency of formats of visual acuity reporting and frequency of providing Snellen equivalents when non-Snellen formats are given. The 4 journals reviewed had the second, fourth, fifth, and ninth highest impact factors for ophthalmology journals in 2015. Of 1881 articles reviewed, 807 (42.9%) provided a visual acuity measurement. Of these, 396 (49.1%) used only a Snellen format; 411 (50.9%) used a non-Snellen format. Among those using a non-Snellen format, 145 (35.3%) provided a Snellen equivalent while 266 (64.7%) provided only a non-Snellen format. More than half of all articles in 4 ophthalmology clinical journals fail to provide a Snellen equivalent when visual acuity is not in a Snellen format. Since many US ophthalmologists may not comprehend non-Snellen formats easily, these data suggest that editors and publishing staff should encourage authors to provide Snellen equivalents whenever visual acuity data are reported in a non-Snellen format to improve ease of understanding visual acuity measurements.

California Charter Oversight: Key Elements and Actual Costs. CRB 12-001

ERIC Educational Resources Information Center

Blanton, Rebecca E.

2012-01-01

This study was mandated by SB537 (Simitian, Chapter 650, Stats. of 2007, codified at Ed. Code Section 47613), which requires the California Research Bureau (CRB) to prepare and submit to the Legislature a report on the key elements and actual costs of charter school oversight. Charter schools are public schools that are operated by entities other…

The association between automatic thoughts about eating, the actual-ideal weight discrepancies, and eating disorders symptoms: a longitudinal study in late adolescence.

PubMed

Zarychta, Karolina; Luszczynska, Aleksandra; Scholz, Urte

2014-06-01

This study tested the reciprocal relationships between automatic thoughts about eating and the actual-ideal weight discrepancies, and their role in the formation and maintenance of eating disorders (ED) symptoms in a non-clinical sample of adolescents. In particular, we investigated whether thoughts about eating mediated the effects of weight discrepancies on ED formation and whether weight discrepancies mediated the effects of thoughts about eating on ED formation were investigated. Data were collected three times, with a 2-month interval between Time 1 (T1) and Time 2 (T2), and a 9-month interval between T2 and Time 3 (T3). Adolescents (N = 55) aged 15-18 filled out the SCOFF Questionnaire, assessing eating disorders symptoms, and the Eating Disorder Thoughts Questionnaire, evaluating automatic thoughts. To assess weight discrepancies questions about actual (subjectively reported) and ideal body weight were asked followed by objective measurement of height and weight. Negative thoughts about eating (T2) mediated the relation between weight discrepancies (T1) and symptoms of anorexia and bulimia (T3). In addition, the association between negative thoughts (T1) and eating disorders symptoms (T3) was mediated by weight discrepancies (T2). The negative thoughts and the actual (both subjectively reported and objectively measured)-ideal weight discrepancies constitute a vicious cycle, related to higher ED symptoms. Prevention of eating disorders should be directed to adolescents who manifest large weight discrepancies or high levels of negative thoughts about eating, as they are at risk for developing eating disorder symptoms.

The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

PubMed

Borgerson, Dawn; Dino, Jennifer

2012-01-01

Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

Avatars mirroring the actual self versus projecting the ideal self: the effects of self-priming on interactivity and immersion in an exergame, Wii Fit.

PubMed

Jin, Seung-A Annie

2009-12-01

As exergames are increasingly being used as an interventional tool to fight the obesity epidemic in clinical studies, society is absorbing their impact to a more intense degree. Interactivity and immersion are key factors that attract exergame consumers. This research asks, What are the effects of priming the actual self versus the ideal self on users' perceived interactivity and immersion in avatar-based exergame playing? and What are important moderators that play a role in exergame users' self-concept perception? To answer these research questions, this study leveraged the Wii's avatar-creating function (Mii Channel) and exergame feature (Wii Fit) in a controlled, randomized experimental design (N = 126). The results of a 2 x 2 factorial design experiment demonstrated the significant main effect of self-priming on interactivity and the moderating role of the actual-ideal self-concept discrepancy in influencing immersion during exergame playing. Game players who created an avatar reflecting the ideal self reported greater perceived interactivity than those who created a replica avatar mirroring the actual self. A two-way ANOVA demonstrated the moderating role of the actual-ideal self-concept discrepancy in determining the effects of the primed regulatory focus on immersion in the exergame play. The underlying theoretical mechanism is derived from and explained by Higgins's self-concept discrepancy perspective. Practical implications for game developers and managerial implications for the exergame industry are discussed.

Investigation of standard care versus sham Reiki placebo versus actual Reiki therapy to enhance comfort and well-being in a chemotherapy infusion center.

PubMed

Catlin, Anita; Taylor-Ford, Rebecca L

2011-05-01

To determine whether provision of Reiki therapy during outpatient chemotherapy is associated with increased comfort and well-being. Double-blind, randomized clinical controlled trial. Outpatient chemotherapy center. 189 participants were randomized to actual Reiki, sham Reiki placebo, or standard care. Patients receiving chemotherapy were randomly placed into one of three groups. Patients received either standard care, a placebo, or an actual Reiki therapy treatment. A demographic tool and pre- and post-tests were given before and after chemotherapy infusion. Reiki therapy, sham Reiki placebo therapy, standard care, and self-reported levels of comfort and well-being pre- and postintervention. Although Reiki therapy was statistically significant in raising the comfort and well-being of patients post-therapy, the sham Reiki placebo also was statistically significant. Patients in the standard care group did not experience changes in comfort and well-being during their infusion session. The findings indicate that the presence of an RN providing one-on-one support during chemotherapy was influential in raising comfort and well-being levels, with or without an attempted healing energy field. An attempt by clinic nurses to provide more designated one-to-one presence and support for patients while receiving their chemotherapy infusions could increase patient comfort and well-being.

Actual performance of mechanical ventilators in ICU: a multicentric quality control study.

PubMed

Govoni, Leonardo; Dellaca', Raffaele L; Peñuelas, Oscar; Bellani, Giacomo; Artigas, Antonio; Ferrer, Miquel; Navajas, Daniel; Pedotti, Antonio; Farré, Ramon

2012-01-01

Even if the performance of a given ventilator has been evaluated in the laboratory under very well controlled conditions, inappropriate maintenance and lack of long-term stability and accuracy of the ventilator sensors may lead to ventilation errors in actual clinical practice. The aim of this study was to evaluate the actual performances of ventilators during clinical routines. A resistance (7.69 cmH(2)O/L/s) - elastance (100 mL/cmH(2)O) test lung equipped with pressure, flow, and oxygen concentration sensors was connected to the Y-piece of all the mechanical ventilators available for patients in four intensive care units (ICUs; n = 66). Ventilators were set to volume-controlled ventilation with tidal volume = 600 mL, respiratory rate = 20 breaths/minute, positive end-expiratory pressure (PEEP) = 8 cmH(2)O, and oxygen fraction = 0.5. The signals from the sensors were recorded to compute the ventilation parameters. The average ± standard deviation and range (min-max) of the ventilatory parameters were the following: inspired tidal volume = 607 ± 36 (530-723) mL, expired tidal volume = 608 ± 36 (530-728) mL, peak pressure = 20.8 ± 2.3 (17.2-25.9) cmH(2)O, respiratory rate = 20.09 ± 0.35 (19.5-21.6) breaths/minute, PEEP = 8.43 ± 0.57 (7.26-10.8) cmH(2)O, oxygen fraction = 0.49 ± 0.014 (0.41-0.53). The more error-prone parameters were the ones related to the measure of flow. In several cases, the actual delivered mechanical ventilation was considerably different from the set one, suggesting the need for improving quality control procedures for these machines.

Temporomandibular joint dysfunction syndrome. A clinical report.

PubMed

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

1985-08-01

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

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications–a cross-sectional study

PubMed Central

Earley, Amy; Lau, Joseph; Uhlig,, Katrin

2013-01-01

Context A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. Objective To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Design Registry-based study of clinical trial results reporting. Setting ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. Selection criteria A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. Main outcome measure ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. Results In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Conclusions Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and

Perceived and Actual Change in Religion/Spirituality in Cancer Survivors: Longitudinal Relationships With Distress and Perceived Growth

PubMed Central

Trevino, Kelly M.; Naik, Aanand D.; Moye, Jennifer

2016-01-01

This observational cohort study examined the relationships between actual and perceived R/S change at 12 months post cancer diagnosis with depression, anxiety, and perceived growth 6 months later. Older adult military veteran cancer survivors (n = 111) completed self-report surveys at 6, 12, and 18 months post cancer diagnosis. Perceived R/S change was assessed at 12 months postdiagnosis with “Have your religious or spiritual beliefs changed as a result of your cancer” (more R/S, less R/S, other). Actual R/S change was assessed at 6 and 12 months postdiagnosis on a single item, “I have faith in God or a Higher Power” (no, somewhat, yes). A notable minority reported perceived (18.9%) and actual (14.4%) change. Greater perceived R/S change predicted more severe symptoms of depression and anxiety and greater perceived growth at 18 months postdiagnosis; perceived growth was positively associated with anxiety. Cancer survivors who report R/S changes may benefit from spiritual and/or psychological support. PMID:27453768

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

PubMed

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 (p<0.001), multicenter trials (p<0.001) and publication 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.

Advance modern medicine with clinical case reports.

PubMed

Wáng, Yì-Xiáng J

2014-12-01

Randomized clinical trial (RCT) can fail to demonstrate the richness of individual patient characteristics. Given the unpredictable nature of medicine, a patient may present in an unusual way, have a strange new pathology, or react to a medical intervention in a manner not seen before. The publication of these novelties as case reports is a fundamental way of conveying medical knowledge. Throughout history there have been famous case studies that shaped the way we view health and disease. Case reports can have the following functions: (I) descriptions of new diseases; (II) study of mechanisms; (III) discovery new therapies; (IV) recognition of side effects; and (V) education. Before submitting a case report, it is worthwhile to refer to the Case Report Check Sheet described by Green and Johnson [2006].

[Current clinical significance of anaerobic bacteremia].

PubMed

Jirsa, Roman; Marešová, Veronika; Brož, Zdeněk

2010-10-01

to estimate tje current clinical significance of anaerobic bacteremia in a group of Czech hospitals. this retrospective analysis comprised 8 444 anaerobic blood cultures in patients admitted to four Czech hospitals between 2004 and 2007. in 16 patients, blood cultures yielded significant anaerobic bacteria. Thus, anaerobic bacteremia accounted for less than 2 % of clinically significant bacteremia. Four patients (18 %) died but none of the deaths could be clearly attributable to anaerobic bacteria in the bloodstream. The most common comorbidities predisposing to anaerobic bacteremia and the most frequent sources of infection were similar to those reported by other authors. The majority of anaerobic bacteremia cases were due to gram-negative bacteria, followed by Clostridium perfringens and, surprisingly, Eubacterium spp. (particularly Eubacterium lentum). anaerobic bacteremia remains rare. The comparison of our data with those by other authors suggests that (despite the reported high mortality) the actual clinical significance of anaerobic bacteremia is rather controversial and that the anaerobic bacteremia might not correspond to more serious pathogenic role of the anaerobic bacteria as the source of infection.

Comparative analysis of operational forecasts versus actual weather conditions in airline flight planning: Summary report

NASA Technical Reports Server (NTRS)

Keitz, J. F.

1982-01-01

The impact of more timely and accurate weather data on airline flight planning with the emphasis on fuel savings is studied. This summary report discusses the results of each of the four major tasks of the study. Task 1 compared airline flight plans based on operational forecasts to plans based on the verifying analyses and found that average fuel savings of 1.2 to 2.5 percent are possible with improved forecasts. Task 2 consisted of similar comparisons but used a model developed for the FAA by SRI International that simulated the impact of ATc diversions on the flight plans. While parts of Task 2 confirm the Task I findings, inconsistency with other data and the known impact of ATC suggests that other Task 2 findings are the result of errors in the model. Task 3 compares segment weather data from operational flight plans with the weather actually observed by the aircraft and finds the average error could result in fuel burn penalties (or savings) of up to 3.6 percent for the average 8747 flight. In Task 4 an in-depth analysis of the weather forecast for the 33 days included in the study finds that significant errors exist on 15 days. Wind speeds in the area of maximum winds are underestimated by 20 to 50 kts., a finding confirmed in the other three tasks.

Whiteheadian Actual Entitities and String Theory

NASA Astrophysics Data System (ADS)

Bracken, Joseph A.

2012-06-01

In the philosophy of Alfred North Whitehead, the ultimate units of reality are actual entities, momentary self-constituting subjects of experience which are too small to be sensibly perceived. Their combination into "societies" with a "common element of form" produces the organisms and inanimate things of ordinary sense experience. According to the proponents of string theory, tiny vibrating strings are the ultimate constituents of physical reality which in harmonious combination yield perceptible entities at the macroscopic level of physical reality. Given that the number of Whiteheadian actual entities and of individual strings within string theory are beyond reckoning at any given moment, could they be two ways to describe the same non-verifiable foundational reality? For example, if one could establish that the "superject" or objective pattern of self- constitution of an actual entity vibrates at a specific frequency, its affinity with the individual strings of string theory would be striking. Likewise, if one were to claim that the size and complexity of Whiteheadian 'societies" require different space-time parameters for the dynamic interrelationship of constituent actual entities, would that at least partially account for the assumption of 10 or even 26 instead of just 3 dimensions within string theory? The overall conclusion of this article is that, if a suitably revised understanding of Whiteheadian metaphysics were seen as compatible with the philosophical implications of string theory, their combination into a single world view would strengthen the plausibility of both schemes taken separately. Key words: actual entities, subject/superjects, vibrating strings, structured fields of activity, multi-dimensional physical reality.

From days to hours: reporting clinically actionable variants from whole genome sequencing.

PubMed

Middha, Sumit; Baheti, Saurabh; Hart, Steven N; Kocher, Jean-Pierre A

2014-01-01

As the cost of whole genome sequencing (WGS) decreases, clinical laboratories will be looking at broadly adopting this technology to screen for variants of clinical significance. To fully leverage this technology in a clinical setting, results need to be reported quickly, as the turnaround rate could potentially impact patient care. The latest sequencers can sequence a whole human genome in about 24 hours. However, depending on the computing infrastructure available, the processing of data can take several days, with the majority of computing time devoted to aligning reads to genomics regions that are to date not clinically interpretable. In an attempt to accelerate the reporting of clinically actionable variants, we have investigated the utility of a multi-step alignment algorithm focused on aligning reads and calling variants in genomic regions of clinical relevance prior to processing the remaining reads on the whole genome. This iterative workflow significantly accelerates the reporting of clinically actionable variants with no loss of accuracy when compared to genotypes obtained with the OMNI SNP platform or to variants detected with a standard workflow that combines Novoalign and GATK.

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

PubMed

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.

Test set readings predict clinical performance to a limited extent: preliminary findings

NASA Astrophysics Data System (ADS)

Soh, BaoLin P.; Lee, Warwick M.; Kench, Peter L.; Reed, Warren M.; McEntee, Mark F.; Brennan, Patrick C.

2013-03-01

Aim: To investigate the level of agreement between test sets and actual clinical reading Background: The performance of screen readers in detecting breast cancer is being assessed in some countries by using mammographic test sets. However, previous studies have provided little evidence that performance assessed by test sets strongly correlate to performance in clinical reading. Methods: Five clinicians from BreastScreen New South Wales participated in this study. Each clinician was asked to read 200 de-identified mammographic examinations gathered from their own case history within the BreastScreen NSW Digital Imaging Library. All test sets were designed with specific proportions of true positive, true negative, false positive and false negative examinations from the previous actual clinical reads of each reader. A prior mammogram examination for comparison (when available) was also provided for each case. Results: Preliminary analyses have shown that there is a moderate level of agreement (Kappa 0.42-0.56, p < 0.001) between laboratory test sets and actual clinical reading. In addition, a mean increase of 38% in sensitivity in the laboratory test sets as compared to their actual clinical readings was demonstrated. Specificity is similar between the laboratory test sets and actual clinical reading. Conclusion: This study demonstrated a moderate level of agreement between actual clinical reading and test set reading, which suggests that test sets have a role in reflecting clinical performance.

The preferred walk to run transition speed in actual lunar gravity.

PubMed

De Witt, John K; Edwards, W Brent; Scott-Pandorf, Melissa M; Norcross, Jason R; Gernhardt, Michael L

2014-09-15

Quantifying the preferred transition speed (PTS) from walking to running has provided insight into the underlying mechanics of locomotion. The dynamic similarity hypothesis suggests that the PTS should occur at the same Froude number across gravitational environments. In normal Earth gravity, the PTS occurs at a Froude number of 0.5 in adult humans, but previous reports found the PTS occurred at Froude numbers greater than 0.5 in simulated lunar gravity. Our purpose was to (1) determine the Froude number at the PTS in actual lunar gravity during parabolic flight and (2) compare it with the Froude number at the PTS in simulated lunar gravity during overhead suspension. We observed that Froude numbers at the PTS in actual lunar gravity (1.39±0.45) and simulated lunar gravity (1.11±0.26) were much greater than 0.5. Froude numbers at the PTS above 1.0 suggest that the use of the inverted pendulum model may not necessarily be valid in actual lunar gravity and that earlier findings in simulated reduced gravity are more accurate than previously thought. © 2014. Published by The Company of Biologists Ltd.

Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data.

PubMed

Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

2013-10-01

Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The

Kindler syndrome: a case report and proposal for clinical diagnostic criteria.

PubMed

Fischer, Irena Angelova; Kazandjieva, Jana; Vassileva, Snejina; Dourmishev, Assen

2005-06-01

Kindler syndrome is a rare hereditary disorder characterized by acral blister formation in infancy and childhood, progressive poikiloderma, cutaneous atrophy and increased photosensitivity. Since it was first described in 1954, less than 100 cases have been reported worldwide. Recently it has been reported that Kindler syndrome is the first genodermatosis caused by a defect in the actin-extracellular matrix linkage, and the gene was mapped to chromosome 20p12.3. The clinical features of the syndrome have been annotated by different authors but the definite of criteria to confirm the diagnosis have not yet been generally accepted. We report a case of Kindler syndrome that presents a full spectrum of clinical manifestations, and we propose a set of clinical criteria for diagnosis.

Perceived and actual competence among overweight and non-overweight children.

PubMed

Jones, Rachel A; Okely, Anthony D; Caputi, Peter; Cliff, Dylan P

2010-11-01

Child overweight and obesity continues to be a global public health concern. The aim of this study was to investigate whether children's actual and perceived physical competence and parental perception's of their child's competence differ by weight status. Understanding these differences is important because physical activity levels are significantly lower among overweight children than their lean counterparts and children's motivation to participate in physical activity is influenced by their perceived and actual competence and their parents perceptions of their competence. Cross-sectional data were collected from 1414 9- and 11-year-old children and their parents from 20 primary schools in New South Wales, Australia. Outcomes measured included child and parental perceptions of physical competence and children's actual physical competence. Parents of overweight boys perceived them to be significantly less competent than parents of non-overweight boys. For 11-year-old girls, parent's perception of their daughter's ability to run (mean diff=1.06 [95% CI 0.73, 1.40]), jump (mean diff=0.54 [95% CI 0.15, 0.93]) and leap (mean diff=0.78 [95% CI 0.41, 1.17]) was lower among parents of overweight children. Overweight children also reported lower perceived physical competence than non-overweight children. 9- and 11-year-old overweight boys had lower actual physical competence than non-overweight boys (mean diff=1.32 [95% CI 0.29, 2.35]; mean diff=1.26 [95% CI 0.37, 2.15], respectively). Overweight 11-year-old girls had lower actual competence than non-overweight 11-year-old girls (mean diff=1.14 [95% CI 0.70, 2.12]). This study highlighted several differences between overweight and non-overweight children. Better understanding these differences at different stages of development may lead to identifying more specific and appropriate intervention points to promote physical activity in overweight children. Crown Copyright © 2010. Published by Elsevier Ltd. All rights

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

PubMed

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.

PubMed

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.

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

PubMed Central

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

2017-01-01

Objectives 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. Setting The setting for this research was a major academic institution in Beijing, China. Participants 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. Methods 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. Results 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. Conclusion 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

Prospective Associations of Actual and Perceived Descriptive Norms with Drinking Among Emerging Adults.

PubMed

Simons-Morton, Bruce; Haynie, Denise; Bible, Joe; Liu, Danping

2018-02-05

Descriptive norms are commonly associated with participant drinking. However, study participants may incorrectly perceive that their peers drink about the same amount as they do, which would bias estimates of drinking homogeneity. This research examined the magnitude of associations between emerging adults' reports of their own drinking and peer drinking measured the previous year by measures of (1) participants' perceptions of friends' drinking; and (2) actual drinking reported by nominated peers. The data are from annual surveys conducted in 2014 and 2015, Waves 4 and 5 (the first 2 years after high school) of 7 annual assessments as part of the NEXT Generation Health Study (n = 323). Associations of participant alcohol use with perceived friend use (five closest, closest male, and closest female friends), and with actual peer use. Logistic regression analyses estimated the magnitudes of prospective associations between each measure of peer drinking at W4 and participant drinking at W5.

Discordance between 'actual' and 'scheduled' check-in times at a heart failure clinic

PubMed Central

Joyce, Emer; Gandesbery, Benjamin T.; Blackstone, Eugene H.; Taylor, David O.; Tang, W. H. Wilson; Starling, Randall C.; Hachamovitch, Rory

2017-01-01

Introduction A 2015 Institute Of Medicine statement “Transforming Health Care Scheduling and Access: Getting to Now”, has increased concerns regarding patient wait times. Although waiting times have been widely studied, little attention has been paid to the role of patient arrival times as a component of this phenomenon. To this end, we investigated patterns of patient arrival at scheduled ambulatory heart failure (HF) clinic appointments and studied its predictors. We hypothesized that patients are more likely to arrive later than scheduled, with progressively later arrivals later in the day. Methods and results Using a business intelligence database we identified 6,194 unique patients that visited the Cleveland Clinic Main Campus HF clinic between January, 2015 and January, 2017. This clinic served both as a tertiary referral center and a community HF clinic. Transplant and left ventricular assist device (LVAD) visits were excluded. Punctuality was defined as the difference between ‘actual’ and ‘scheduled’ check-in times, whereby negative values (i.e., early punctuality) were patients who checked-in early. Contrary to our hypothesis, we found that patients checked-in late only a minority of the time (38% of visits). Additionally, examining punctuality by appointment hour slot we found that patients scheduled after 8AM had progressively earlier check-in times as the day progressed (P < .001 for trend). In both a Random Forest-Regression framework and linear regression models the most important risk-adjusted predictors of early punctuality were: later in the day appointment hour slot, patient having previously been to the hospital, age in the early 70s, and white race. Conclusions Patients attending a mixed population ambulatory HF clinic check-in earlier than scheduled times, with progressive discrepant intervals throughout the day. This finding may have significant implications for provider utilization and resource planning in order to maximize clinic

Developing Clinical Information Needs and Systems. Final Grant Report.

ERIC Educational Resources Information Center

Noback, Richardson K.; Byrd, Gary D.

This report represents the extended research following an initial three-year grant reported on in 1975. Goals were: (1) to enact, observe, and assess the results of a program in which medical librarians become integral members of multi-disciplinary patient care and educational teams; and (2) to test the ability of these Clinical Medical Librarians…

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

PubMed

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.

Power Delivery from an Actual Thermoelectric Generation System

NASA Astrophysics Data System (ADS)

Kaibe, Hiromasa; Kajihara, Takeshi; Nagano, Kouji; Makino, Kazuya; Hachiuma, Hirokuni; Natsuume, Daisuke

2014-06-01

Similar to photovoltaic (PV) and fuel cells, thermoelectric generators (TEGs) supply direct-current (DC) power, essentially requiring DC/alternating current (AC) conversion for delivery as electricity into the grid network. Use of PVs is already well established through power conditioning systems (PCSs) that enable DC/AC conversion with maximum-power-point tracking, which enables commercial use by customers. From the economic, legal, and regulatory perspectives, a commercial PCS for PVs should also be available for TEGs, preferably as is or with just simple adjustment. Herein, we report use of a PV PCS with an actual TEG. The results are analyzed, and proper application for TEGs is proposed.

Report of the Task Force on Clinical Research in Dentistry.

ERIC Educational Resources Information Center

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…

Striving to Feel Good: Ideal Affect, Actual Affect, and Their Correspondence Across Adulthood

PubMed Central

Scheibe, Susanne; English, Tammy; Tsai, Jeanne L.; Carstensen, Laura L.

2013-01-01

The experience of positive affect is essential for healthy functioning and quality of life. Although there is a great deal of research on ways in which people regulate negative states, little is known about the regulation of positive states. In the present study we examined age differences in the types of positive states people strive to experience and the correspondence between their desired and actual experiences. Adults aged 18–93 years of age described their ideal positive affect states. Then, using experience-sampling over a seven-day period, they reported their actual positive affect experiences. Two types of positive affect were assessed: low-arousal (calm, peaceful, relaxed) and high-arousal (excited, proud). Young participants valued both types of positive affect equally. Older participants, however, showed increasingly clear preferences for low-arousal over high-arousal positive affect. Older adults reached both types of positive affective goals more often than younger adults (indicated by a smaller discrepancy between actual and ideal affect). Moreover, meeting ideal levels of positive low-arousal affect (though not positive high-arousal affect) was associated with individuals’ physical health, over and above levels of actual affect. Findings underscore the importance of considering age differences in emotion-regulatory goals related to positive experience. PMID:23106153

Physician job satisfaction related to actual and preferred job size.

PubMed

Schmit Jongbloed, Lodewijk J; Cohen-Schotanus, Janke; Borleffs, Jan C C; Stewart, Roy E; Schönrock-Adema, Johanna

2017-05-11

Job satisfaction is essential for physicians' well-being and patient care. The work ethic of long days and hard work that has been advocated for decades is acknowledged as a threat for physicians' job satisfaction, well-being, and patient safety. Our aim was to determine the actual and preferred job size of physicians and to investigate how these and the differences between them influence physicians' job satisfaction. Data were retrieved from a larger, longitudinal study among physicians starting medical training at Groningen University in 1982/83/92/93 (N = 597). Data from 506 participants (85%) were available for this study. We used regression analysis to investigate the influence of job size on physicians' job satisfaction (13 aspects) and ANOVA to examine differences in job satisfaction between physicians wishing to retain, reduce or increase job size. The majority of the respondents (57%) had an actual job size less than 1.0 FTE. More than 80% of all respondents preferred not to work full-time in the future. Respondents' average actual and preferred job sizes were .85 FTE and .81 FTE, respectively. On average, respondents who wished to work less (35% of respondents) preferred a job size reduction of 0.18 FTE and those who wished to work more (12%) preferred an increase in job size of 0.16 FTE. Job size influenced satisfaction with balance work-private hours most (β = -.351). Physicians who preferred larger job sizes were - compared to the other groups of physicians - least satisfied with professional accomplishments. A considerable group of physicians reported a gap between actual and preferred job size. Realizing physicians' preferences as to job size will hardly affect total workforce, but may greatly benefit individual physicians as well as their patients and society. Therefore, it seems time for a shift in work ethic.

[A report on clinical PET activities in Germany].

PubMed

Tashiro, M; Kubota, K; Itoh, M; Sasaki, H; Moser, E

1999-09-01

Clinical diagnostic procedure using positron emission tomography (PET) requires high costs. To promote clinical use of PET, sociomedical evaluation is necessary. In this paper, sociomedical situations concerning clinical use of PET in Germany is reported. Some comparisons are made between Japan and this country putting emphases on several points such as 1) number of cyclotron and PET facilities, 2) social restriction to transportation of radioisotopes, 3) activities of satellite PET facilities, and 4) clinical indications for PET studies. Number of cyclotron was larger in Japan (29) than in Germany (17), but number of PET facilities was larger in Germany (47) than in Japan (29). The reason seems that in Germany transportation and buying of radioisotopes is less restricted. Hence, more than half of PET facilities in Germany are "satellite facilities" which do not have their own cyclotrons. Radioisotope distribution seems to serve as a backbone of "satellite concept." Additionally in Germany, list of clinical indications for PET study is almost completed and now is widely in applied to most cases. To promote clinical use of PET in Japan, the German system might serve as an important socioeconomic model in Europe instead of the United States.

Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

PubMed Central

Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

2013-01-01

Background Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. Methods and Findings We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically

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

PubMed

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.

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

PubMed

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

Using the journal BMJ Case Reports to promote the publication of clinical case reports

PubMed Central

Montano, Blanca San José

2016-01-01

Objective The study updates and enhances clinicians' knowledge about clinical case reports (CCRs) and encourages publication of such articles. Methods The author developed and offered a session about BMJ Case Reports to medical and surgical departments in the University Hospital of Móstoles. The session reviewed the contents and add-on services of the journal, conventional and alternative indicators of journal quality, use of CCRs to share valuable clinical lessons, and manuscript preparation and submission. Results The main result of these sessions was submission of eight CCRs to BMJ Case Reports, of which four were accepted. One submitting author was invited to serve as peer reviewer for the journal. Other clinicians are preparing five new CCRs for submission to BMJ Case Reports or other journals. Conclusions The learning sessions were successful in promoting writing and publication of CCRs. Young staff and postgraduate residents seemed especially encouraged to publish CCRs that had already been presented in their departmental sessions. As a librarian, I gained experience in CCR publication and reinforced my position as an essential supporter of the hospital's teaching and publishing activity. PMID:27822158

A Urinalysis Result Reporting System for a Clinical Laboratory

PubMed Central

Sullivan, James E.; Plexico, Perry S.; Blank, David W.

1987-01-01

A menu driven Urinalysis Result Reporting System based on multiple IBM-PC Workstations connected together by a local area network was developed for the Clinical Chemistry Section of the Clinical Pathology Department at the National Institutes of Health's Clinical Center. Two Network File Servers redundantly save the test results of each urine specimen. When all test results for a specimen are entered into the system, the results are transmitted to the Department's Laboratory Computer System where they are made available to the ordering physician. The Urinalysis Data Management System has proven easy to learn and use.

19 CFR 162.79b - Recovery of actual loss of duties, taxes and fees or actual loss of revenue.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 2 2010-04-01 2010-04-01 false Recovery of actual loss of duties, taxes and fees or actual loss of revenue. 162.79b Section 162.79b Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT OF THE TREASURY (CONTINUED) INSPECTION, SEARCH, AND SEIZURE...

Final Report. LAW Glass Formulation to Support AP-101 Actual Waste Testing, VSL-03R3470-2, Rev. 0

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

Muller, I. S.; Pegg, I. L.; Rielley, Elizabeth

2015-06-22

The main objective of the work was to develop and select a glass formulation for vitrification testing of the actual waste sample of LAW AP-101 at Battelle - Pacific Northwest Division (PNWD). Other objectives of the work included preparation and characterization of glasses to demonstrate compliance with contract and processing requirements, evaluation of the ability to achieve waste loading requirements, testing to demonstrate compatibility of the glass melts with melter materials of construction, comparison of the properties of simulant and actual waste glasses, and identification of glass formulation issues with respect to contract specifications and processing requirements.

Concordance between actual and pharmacogenetic predicted desvenlafaxine dose needed to achieve remission in major depressive disorder: a 10-week open-label study.

PubMed

Bousman, Chad A; Müller, Daniel J; Ng, Chee H; Byron, Keith; Berk, Michael; Singh, Ajeet B

2017-01-01

Pharmacogenetic-based dosing support tools have been developed to personalize antidepressant-prescribing practice. However, the clinical validity of these tools has not been adequately tested, particularly for specific antidepressants. To examine the concordance between the actual dose and a polygene pharmacogenetic predicted dose of desvenlafaxine needed to achieve symptom remission. A 10-week, open-label, prospective trial of desvenlafaxine among Caucasian adults with major depressive disorder (n=119) was conducted. Dose was clinically adjusted and at the completion of the trial, the clinical dose needed to achieve remission was compared with the predicted dose needed to achieve remission. Among remitters (n=95), there was a strong concordance (Kendall's τ-b=0.84, P=0.0001; Cohen's κ=0.82, P=0.0001) between the actual and the predicted dose need to achieve symptom remission, showing high sensitivity (≥85%), specificity (≥86%), and accuracy (≥89%) of the tool. Findings provide initial evidence for the clinical validity of a polygene pharmacogenetic-based tool for desvenlafaxine dosing.

40 CFR 74.22 - Actual SO2 emissions rate.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Actual SO2 emissions rate. 74.22... (CONTINUED) SULFUR DIOXIDE OPT-INS Allowance Calculations for Combustion Sources § 74.22 Actual SO2 emissions... actual SO2 emissions rate shall be 1985. (2) For combustion sources that commenced operation after...

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

ERIC Educational Resources Information Center

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…

Relative Proximity Theory: Measuring the Gap between Actual and Ideal Online Course Delivery

ERIC Educational Resources Information Center

Swart, William; MacLeod, Kenneth; Paul, Ravi; Zhang, Aixiu; Gagulic, Mario

2014-01-01

Based on the Theory of Transactional Distance and Needs Assessment, this article reports a procedure for quantitatively measuring how close the actual delivery of a course was to ideal, as perceived by students. It extends Zhang's instrument and prescribes the computational steps to calculate relative proximity at the element and construct…

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Fat embolism syndrome: Case report of a clinical conundrum

PubMed Central

Nandi, Roneeta; Venkategowda, Pradeep Marur; Mutkule, Dnyaneshwar; Rao, Surath Manimala

2014-01-01

Fat embolism syndrome is a rare clinical condition associated with trauma, particularly of long bones. FES after fracture of neck of femur or head of humerus is uncommon. We report a case of FES following fracture in neck of femur and head of humerus in a man with history of mitral valve replacement, on long-term oral anticoagulant therapy, with an alleged history of convulsions. Our dilemma in clinical diagnosis is discussed. PMID:25190956

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

PubMed

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

Personal birth preferences and actual mode of delivery outcomes of obstetricians and gynaecologists in South West England; with comparison to regional and national birth statistics.

PubMed

Lightly, Katie; Shaw, Elisabeth; Dailami, Narges; Bisson, Dina

2014-10-01

To determine personal birth preferences of obstetricians in various clinical scenarios, in particular elective caesarean section for maternal request. To determine actual rates of modes of deliveries amongst the same group. To compare the obstetrician's mode of delivery rates, to the general population. Following ethical approval, a piloted online survey link was sent via email to 242 current obstetricians and gynaecologists, (consultants and trainees) in South West England. Mode of delivery results were compared to regional and national population data, using Hospital Episode Statistics and subjected to statistical analysis. The response rate was 68%. 90% would hypothetically plan a vaginal delivery, 10% would consider a caesarean section in an otherwise uncomplicated primiparous pregnancy. Of the 94/165 (60%) respondents with children (201 children), mode of delivery for the first born child; normal vaginal delivery 48%, caesarean section 26.5% (elective 8.5%, emergency 18%), instrumental 24.5% and vaginal breech 1%. Only one chose an elective caesarean for maternal request. During 2006-2011 obstetricians have the same overall actual modes of birth as the population (p=0.9). Ten percent of obstetricians report they would consider requesting caesarean section for themselves/their partner, which is the lowest rate reported within UK studies. However only 1% actually had a caesarean solely for maternal choice. When compared to regional/national statistics obstetricians currently have modes of delivery that are not significantly different than the population and suggests that they choose non interventional delivery if possible. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

Just a Collection of Recollections: Clinical Ethics Consultation and the Interplay of Evaluating Voices.

PubMed

Bartlett, Virginia L; Bliton, Mark J; Finder, Stuart G

2016-12-01

Despite increased attention to the question of how best to evaluate clinical ethics consultations and emphasis on external evaluation (Hastings Center Report, ASBH Quality Attestation Process), there has been little sustained focus on how we, as clinicians, make sense of and learn from our own experiences in the midst of any one consultation. Questions of how we evaluate the request for, unfolding of, and conclusion of any specific ethics consultation are often overlooked, along with the underlying question of whether it is possible to give an accurate account of clinical ethics consultants' experience as experienced by ethics consultants. Before the challenge of submitting one's accounts or case reports for review and evaluation from others (at one's local institution or in the broader field), there is an underlying challenge of understanding and evaluating our own accounts. To highlight this crucial and deeply challenging dimension of actual clinical ethics practice, we present an account of a complex consultation, explicitly constructed to engage the reader in the unfolding experience of the consultant by emphasizing the multiple perspectives unfolding within the consultant's experience. Written in script format, the three perspectives presented-prototypical clinically descriptive account; didactically reflective and self-evidentiary account often seen in journal presentations; highly self-critical reflective account emphasizing uncertainties inherent to clinical ethics practice-reflect different manners for responding to the ways actual clinical involvement in ethics consultation practice accentuates and refocuses the question of how to understand and evaluate our own work, as well as that of our colleagues.

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

PubMed

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 < 0.001) by 5% following the publication of the report card. The increase was larger and more significant among nursing homes with worse reported quality, lower occupancy, those located in more competitive markets, for-profit ownership and owned by a chain. The increase in the ratio of clinical to 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.

Incorporating development of a patient-reported outcome instrument in a clinical drug development program: examples from a heart failure program.

PubMed

Wiklund, Ingela; Anatchkova, Milena; Oko-Osi, Hafiz; von Maltzahn, Robyn; Chau, Dina; Malik, Fady I; Patrick, Donald L; Spertus, John; Teerlink, John R

2016-09-15

Patient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process. Concept elicitation focus groups and individual interviews were conducted with patients with HF to identify concepts for the instrument. Cognitive interviews with HF patients were used to confirm that no essential concepts were missing and to assess patient comprehension of the instrument and items. During concept elicitation, the most frequently reported HF symptoms were shortness of breath, tiredness, fluid retention, fatigue, dizziness/light-headedness, swelling, weight fluctuation, and trouble sleeping. Two measures were developed based on the concepts: the Heart Failure Symptom Diary (HF-SD) and the Heart Failure Impact Scale (HFIS). Findings from cognitive interviews suggested that the items in the HF-SD and HFIS were relevant and well understood by patients. Multiple iterations of concept elicitation and cognitive interviews were needed based on FDA request for a broader patient population in the qualitative study. Lessons learned from the omecamtiv mecarbil PRO/clinical development program are discussed, including challenges of qualitative studies, patient recruitment, expected and actual timelines, cost, and engagement with various stakeholders. Development of a new PRO measure to support a label claim requires significant investment and early planning, as demonstrated by the omecamtiv mecarbil program.

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

PubMed

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.

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

PubMed Central

Macefield, Rhiannon C.; Blencowe, Natalie S.; Brookes, Sara T.; Blazeby, Jane M.

2016-01-01

Purpose 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. Materials and Methods 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. Results 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). Conclusion It is recommended that single

Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States

PubMed Central

Lassman, Scott M; Shopshear, Olivia M; Jazic, Ina; Ulrich, Jocelyn; Francer, Jeffrey

2017-01-01

Objective To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies. Design We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance analyses and conclusions were valid. Data sources Information from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors. Main outcome measures Compliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA). Results Industry compliance with FDAAA disclosure requirements was notably higher than reported by Miller et al. Among trials subject to FDAAA, Miller et al reported that, per drug, a median of 67% (middle 50% range: 0%–100%) of trials fully complied with registration and results reporting requirements. On reanalysis of the data, we found that a median of 100% (middle 50% range: 93%–100%) of clinical trials for a particular drug fully complied with the law. When looking at overall compliance at the trial level, our reassessment yields 94% timely registration and 90% timely results reporting among the 49 eligible trials, and an overall FDAAA compliance rate of 86%. Conclusions The claim by Miller et al that industry compliance is below legal standards is based on an analysis that relies on an incomplete dataset and an interpretation of FDAAA that requires disclosure of study results for drugs that have not yet been approved for any indication. On reanalysis using a different interpretation of FDAAA that focuses on whether results were disclosed within 30 days of drug approval, we found that industry compliance with US statutory disclosure requirements for the 15 reviewed drugs was consistently high. PMID:28942418

Significant Discrepancy Between Estimated and Actual Longevity in St. Jude Medical Implantable Cardioverter-Defibrillators.

PubMed

Doppalapudi, Harish; Barrios, James; Cuellar, Jose; Gannon, Melanie; Yamada, Takumi; Kumar, Vineet; Maddox, William R; Plumb, Vance J; Brown, Todd M; McElderry, H Tom

2017-05-01

Real-time estimated longevity has been reported in pacemakers for several years, and was recently introduced in implantable cardioverter-defibrillators (ICDs). We sought to evaluate the accuracy of this longevity estimate in St. Jude Medical (SJM) ICDs, especially as the device battery approaches depletion. Among patients with SJM ICDs who underwent generator replacements due to reaching elective replacement indicator (ERI) at our institution, we identified those with devices that provided longevity estimates and reviewed their device interrogations in the 18 months prior to ERI. Significant discrepancy was defined as a difference of more than 12 months between estimated and actual longevity at any point during this period. Forty-six patients with Current/Promote devices formed the study group (40 cardiac resynchronization therapy [CRT] and 6 single/dual chamber). Of these, 34 (74%) had significant discrepancy between estimated and actual longevity (28 CRT and all single/dual). Longevity was significantly overestimated by the device algorithm (mean maximum discrepancy of 18.8 months), more in single/dual than CRT devices (30.5 vs. 17.1 months). Marked discrepancy was seen at voltages ≥2.57 volts, with maximum discrepancy at 2.57 volts (23 months). The overall longevity was higher in the discrepant group of CRT devices than in the nondiscrepant group (67 vs. 61 months, log-rank P = 0.03). There was significant overestimation of longevity in nearly three-fourths of Current/Promote SJM ICDs in the last 18 months prior to ERI. Longevity estimates of SJM ICDs may not be reliable for making clinical decisions on frequency of follow-up, as the battery approaches depletion. © 2017 Wiley Periodicals, Inc.

Actual and perceived weight status and its association with slimming and energy-balance related behaviours in 10- to 12-year-old European children: the ENERGY-project.

PubMed

Altenburg, T M; Singh, A S; Te Velde, S; De Bourdeaudhuij, I; Lien, N; Bere, E; Molnár, D; Jan, N; Fernández-Alvira, J M; Manios, Y; Bringolf-Isler, B; Brug, J; Chinapaw, M J

2017-04-01

Both parents' and children's perception of children's weight status may be important predictors of slimming and energy-balance related behaviours, independent of children's actual weight status. We examined the cross-sectional association of children's self-reported slimming and energy-balance related behaviours with children's (i) actual, (ii) self-perceived and (iii) parent-perceived weight status. Data of 10- to 12-year-old European children and their parents were used. Multilevel logistic and linear regression analyses were performed, adjusting for age, gender, parental weight controlling behaviours, education, marital status and ethnicity. Independent of their actual weight status, a higher proportion of children reported slimming when they or their parents perceived them as too fat. Children's self-perceived weight status was more strongly associated with slimming than their parents' perception or their actual weight status. Moreover, children who perceive themselves as overweight reported less physical activity and more screen time. Children whose parents perceive them as overweight reported less physical activity. Children's own perception of their weight status appears to be more important for their self-reported slimming than their actual or their parent's perceptions of their weight status. Additionally, children's self-perceived weight status seems important in engaging more physical activity and reduces screen time. © 2016 World Obesity Federation.

Would Socrates Have Actually Used the "Socratic Method" for Clinical Teaching?

PubMed

Stoddard, Hugh A; O'Dell, David V

2016-09-01

Medical students and residents are familiar with clinical teaching methods in which a faculty member poses a series of questions to them. This technique is often called the "Socratic method," but it is frequently perceived by learners as an attempt to demean them, a practice that is colloquially known as "pimping." The distinction between Socratic teaching and pimping lies in the perception of "psychological safety." Psychological safety allows learners to answer questions or ask for help without threats to their dignity or worthiness. In a psychologically safe clinical teaching context, learners recognize that questions posed by attending physicians probe their current understanding and guide them to expand their knowledge. In pimping, questions are posed to embarrass the learner and to reinforce the teacher's position of power over them. Absent a threat of disparagement or condemnation, learners are able to focus on building schema for knowledge, skills, and attitudes, rather than worrying about shielding their self-worth. This article presents the proper Socratic method, as intended by Socrates, and contrasts it with pimping. This perspective defines psychological safety as the pivotal factor distinguishing Socratic teaching from pimping, and establishes the foundation for empirical studies of these common practices in medical education.

Development of a pioneering clinical support system utilizing information technology.

PubMed

Hayashi, Doubun; Imai, Yasushi; Morita, Hiroyuki; Fujita, Hideo; Monzen, Koshiro; Harada, Tomohiro; Nojiri, Takefumi; Yamazaki, Tadashi; Yamazaki, Tsutomu; Nagai, Ryozo

2004-03-01

Nowadays, evidence-based medicine has entered the mainstream of clinical judgement and the human genome has been completely decoded. Even the concept of individually designed medicine, that is, tailor-made medicine, is now being discussed. Due to their complexity, however, management methods for clinical information have yet to be established. We have conducted a study on a universal technique which enables one to select or produce by employing information processing technology clinical findings from various clinical information generated in vast quantity in day-to-day clinical practice, and to share such information and/or the results of analysis between two or more institutions. In this study, clinically useful findings have been successfully obtained by systematizing actual clinical information and genomic information obtained by an appropriate collecting and management method of information with due consideration to ethical issues. We report here these medical achievements as well as technological ones which will play a role in propagating such medical achievements.

Rescuer fatigue during actual in-hospital cardiopulmonary resuscitation with audiovisual feedback: a prospective multicenter study

PubMed Central

Sugerman, Noah T.; Herzberg, Daniel; Leary, Marion; Weidman, Elizabeth K.; Edelson, Dana P.; Vanden Hoek, Terry L.; Becker, Lance B.; Abella, Benjamin S.

2009-01-01

Background Rescuer fatigue during cardiopulmonary resuscitation (CPR) is a likely contributor to variable CPR quality during clinical resuscitation efforts, yet investigations into fatigue and CPR quality degradation have only been performed in simulated environments, with widely conflicting results. Objective We sought to characterize CPR quality decay during actual in-hospital cardiac arrest, with regard to both chest compression (CC) rate and depth during the delivery of CCs by individual rescuers over time. Methods Using CPR-recording technology to objectively quantify CCs and provide audiovisual feedback, we prospectively collected CPR performance data from arrest events in two hospitals. We identified continuous CPR “blocks” from individual rescuers, assessing CC rate and depth over time. Results 135 blocks of continuous CPR were identified from 42 cardiac arrests at the two institutions. Median duration of continuous CPR blocks was 112 sec (IQR 101–122). CC rate did not change significantly over single rescuer performance, with an initial mean rate of 105 ± 11 / min, and a mean rate after 3 min of 106 ± 9 / min (p=NS). However, CC depth decayed significantly starting between 90 sec and 2 min, falling from a mean of 48.3 ± 9.6 mm to 46.0 ± 9.0 mm (p=0.0006) and to 43.7 ± 7.4 mm by 3 minutes (p=0.002). Conclusions During actual in-hospital CPR with audiovisual feedback, CC depth decay became evident after 90 sec of CPR, but CC rate did not change. These data provide clinical evidence for rescuer fatigue during actual resuscitations and support current guideline recommendations to rotate rescuers during CC delivery. PMID:19581036

Examining the Relationship Between Perceived Quality of Care and Actual Quality of Care as Measured by 30-Day Readmission Rates.

PubMed

Salinas, Stanley R

To test the relationship between patient experience, as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), and actual quality of care, as measured by 30-day readmission rates. Both HCAHPS data and outcome data reported to the Centers of Medicare & Medicaid Services (CMS). This secondary, nationwide (N = 4060), hospital-level study focused only on acute care hospitals. HCAHPS question 22 "Would you recommend this hospital to your friends and family?" was used to determine level of overall satisfaction, and 30-day readmission rates, as reported to the CMS, was used as a proxy for actual quality of care. A statistically significant relationship was found between patient experience and actual quality outcomes. The results of this study reinforce the inclusion of patient experience in Medicare's Value Based Purchasing program as a matter of good public policy.

External Validity of Contingent Valuation: Comparing Hypothetical and Actual Payments.

PubMed

Ryan, Mandy; Mentzakis, Emmanouil; Jareinpituk, Suthi; Cairns, John

2017-11-01

Whilst contingent valuation is increasingly used in economics to value benefits, questions remain concerning its external validity that is do hypothetical responses match actual responses? We present results from the first within sample field test. Whilst Hypothetical No is always an Actual No, Hypothetical Yes exceed Actual Yes responses. A constant rate of response reversals across bids/prices could suggest theoretically consistent option value responses. Certainty calibrations (verbal and numerical response scales) minimise hypothetical-actual discrepancies offering a useful solution. Helping respondents resolve uncertainty may reduce the discrepancy between hypothetical and actual payments and thus lead to more accurate policy recommendations. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Rational Behavioral Training and Changes in Self-Actualization.

ERIC Educational Resources Information Center

Johnson, Norbert; And Others

1982-01-01

Examined the effects on self-actualization of CETA supervisors who participated in a Rational Behavioral Training (RBT) group. The Personal Orientation Inventory (POI) was administered to experimental and control groups before and after the group. Results indicated the RBT experience enabled participants to move toward self-actualization. (RC)

Self-Actualization Effects Of A Marathon Growth Group

ERIC Educational Resources Information Center

Jones, Dorothy S.; Medvene, Arnold M.

1975-01-01

This study examined the effects of a marathon group experience on university student's level of self-actualization two days and six weeks after the experience. Gains in self-actualization as a result of marathon group participation depended upon an individual's level of ego strength upon entering the group. (Author)

Tracing Actual Causes

DTIC Science & Technology

2016-08-08

actual values for variables in the SEM ), and an event e with M ,~u |= e, our definition answers the question : Which paths of the causal network G( M ...for each variable and a directed edge from vari- able X to Y if the equation for computing X uses Y . Given an SEM M , a context ~u (that supplies the...caused the event e1? Our definition answers this question as a set of causal slices, where each causal slice is a subgraph of G( M ). All paths in each

Concordance between actual and pharmacogenetic predicted desvenlafaxine dose needed to achieve remission in major depressive disorder: a 10-week open-label study

PubMed Central

Müller, Daniel J.; Ng, Chee H.; Byron, Keith; Berk, Michael; Singh, Ajeet B.

2017-01-01

Background Pharmacogenetic-based dosing support tools have been developed to personalize antidepressant-prescribing practice. However, the clinical validity of these tools has not been adequately tested, particularly for specific antidepressants. Objective To examine the concordance between the actual dose and a polygene pharmacogenetic predicted dose of desvenlafaxine needed to achieve symptom remission. Materials and methods A 10-week, open-label, prospective trial of desvenlafaxine among Caucasian adults with major depressive disorder (n=119) was conducted. Dose was clinically adjusted and at the completion of the trial, the clinical dose needed to achieve remission was compared with the predicted dose needed to achieve remission. Results Among remitters (n=95), there was a strong concordance (Kendall’s τ-b=0.84, P=0.0001; Cohen’s κ=0.82, P=0.0001) between the actual and the predicted dose need to achieve symptom remission, showing high sensitivity (≥85%), specificity (≥86%), and accuracy (≥89%) of the tool. Conclusion Findings provide initial evidence for the clinical validity of a polygene pharmacogenetic-based tool for desvenlafaxine dosing. PMID:27779571

7 CFR 400.51 - Availability of actual production history program.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Availability of actual production history program. 400.51 Section 400.51 Agriculture Regulations of the Department of Agriculture (Continued) FEDERAL CROP... History § 400.51 Availability of actual production history program. An Actual Production History (APH...

7 CFR 400.51 - Availability of actual production history program.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 6 2011-01-01 2011-01-01 false Availability of actual production history program. 400.51 Section 400.51 Agriculture Regulations of the Department of Agriculture (Continued) FEDERAL CROP... History § 400.51 Availability of actual production history program. An Actual Production History (APH...

7 CFR 400.51 - Availability of actual production history program.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 6 2012-01-01 2012-01-01 false Availability of actual production history program. 400.51 Section 400.51 Agriculture Regulations of the Department of Agriculture (Continued) FEDERAL CROP... History § 400.51 Availability of actual production history program. An Actual Production History (APH...

7 CFR 400.51 - Availability of actual production history program.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 6 2014-01-01 2014-01-01 false Availability of actual production history program. 400.51 Section 400.51 Agriculture Regulations of the Department of Agriculture (Continued) FEDERAL CROP... History § 400.51 Availability of actual production history program. An Actual Production History (APH...

7 CFR 400.51 - Availability of actual production history program.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 6 2013-01-01 2013-01-01 false Availability of actual production history program. 400.51 Section 400.51 Agriculture Regulations of the Department of Agriculture (Continued) FEDERAL CROP... History § 400.51 Availability of actual production history program. An Actual Production History (APH...

Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative.

PubMed

Garcia, Sofia F; Cella, David; Clauser, Steven B; Flynn, Kathryn E; Lad, Thomas; Lai, Jin-Shei; Reeve, Bryce B; Smith, Ashley Wilder; Stone, Arthur A; Weinfurt, Kevin

2007-11-10

Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. The Patient-Reported Outcomes Measurement Information System (PROMIS) Network, part of the National Institutes of Health Roadmap Initiative, aims to improve appreciably how PROs are selected and assessed in clinical research, including clinical trials. PROMIS is establishing a publicly available resource of standardized, accurate, and efficient PRO measures of major self-reported health domains (eg, pain, fatigue, emotional distress, physical function, social function) that are relevant across chronic illnesses including cancer. PROMIS is also developing measures of self-reported health domains specifically targeted to cancer, such as sleep/wake function, sexual function, cognitive function, and the psychosocial impacts of the illness experience (ie, stress response and coping; shifts in self-concept, social interactions, and spirituality). We outline the qualitative and quantitative methods by which PROMIS measures are being developed and adapted for use in clinical oncology research. At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.

Minimum reporting standards for clinical research on groin pain in athletes

PubMed Central

Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M; Robinson, Philip; Hölmich, Per; Weir, Adam

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. This will allow an easier comparison of outcomes across studies in the future. PMID:26031644

Dancers' Perceived and Actual Knowledge of Anatomy.

PubMed

Kotler, Dana H; Lynch, Meaghan; Cushman, Daniel; Hu, Jason; Garner, Jocelyn

2017-06-15

Dancers are highly susceptible to musculoskeletal injuries and frequently require interaction with medical professionals. While many dancers have a finely tuned awareness of their bodies, their knowledge of the fundamentals of human anatomy is not uniform. There is a paucity of literature on the benefits of human anatomy education in dancers, though it seems intuitive that there should be a relationship. The purpose of this study was to assess dancers' perceived and actual knowledge of basic musculoskeletal anatomy and its relationship to function. Adult dancers at the undergraduate, pre-professional, and professional levels were surveyed through an anonymous online questionnaire. Questions included demographic information, dance techniques studied, anatomy training, and injury history. Subjects rated their perceived knowledge of anatomy and were tested with 15 multiple-choice questions on basic musculoskeletal anatomy. Four hundred seventy-five surveys were completed. Ordinal regression showed a correlation of perceived to actual knowledge of anatomy (p < 0.001). Factors that correlated with increases in both perceived and actual knowledge of anatomy included having taken an anatomy course of any type (p < 0.001) and increased age (p ≤ 0.001). Years of dance training and professional dancer status both significantly correlated with increased knowledge of anatomy (p < 0.001) but not perceived knowledge. Chi-square analysis showed that dancers with training in either modern or jazz dance had a significantly higher perceived, but not actual, knowledge when compared to those without training in those styles of dance (p < 0.001 and p = 0.011, respectively). In conclusion, dancers generally scored well on questions pertaining to basic musculoskeletal anatomy, and their perception correlated with their actual knowledge of anatomy. Factors that contribute to dancers' knowledge of anatomy include age, years of experience, professional dancer status, and anatomy training.

The Self-Actualization of Polk Community College Students.

ERIC Educational Resources Information Center

Pearsall, Howard E.; Thompson, Paul V., Jr.

This article investigates the concept of self-actualization introduced by Abraham Maslow (1954). A summary of Maslow's Needs Hierarchy, along with a description of the characteristics of the self-actualized person, is presented. An analysis of humanistic education reveals it has much to offer as a means of promoting the principles of…

Assays of dioxins and dioxin-like compounds in actually contaminated soils using transgenic tobacco plants carrying a recombinant mouse aryl hydrocarbon receptor-mediated β-glucuronidase reporter gene expression system.

PubMed

Inui, Hideyuki; Gion, Keiko; Utani, Yasushi; Wakai, Taketo; Kodama, Susumu; Eun, Heesoo; Kim, Yun-Seok; Ohkawa, Hideo

2012-01-01

The transgenic tobacco plant XD4V-26 carrying the recombinant mouse aryl hydrocarbon receptor XD4V-mediated β-glucuronidase (GUS) reporter gene expression system was used for assay of dioxins and dioxin-like compounds consisting of polychlorinated dibenzeno-p-dioxins, polychlorinated dibenzofurans, and coplanar polychlorinated biphenyls (Co-PCBs) in actually contaminated soils. The transgenic tobacco plant XD4V-26 showed a significant dose-dependent induced GUS activity when cultured on MS medium containing PCB126 [toxic equivalency factor (TEF) = 0.1]. In contrast, PCB169 and PCB180, which have 0.03 of TEF and unassigned TEF values, respectively, did not significantly induce GUS activity under the same conditions as with PCB126. When the tobacco plants were cultivated for up to 5 weeks on actually contaminated soils with dioxins and dioxin-like compounds collected from the periphery of an incinerator used for disposal of residential and industrial wastes, GUS activity in the leaves was dose-dependently increased. The plants clearly detected 360 pg-TEQ g(-1) of dioxins and dioxin-like compounds in this assay. There was a positive correlation between GUS activity and TEQ value of dioxins and dioxin-like compounds in the plants. This assay does not require any extraction and purification processes for the actually contaminated soil samples.

Assays of dioxins and dioxin-like compounds in actually contaminated soils using transgenic tobacco plants carrying a recombinant mouse aryl hydrocarbon receptor-mediated β-glucuronidase reporter gene expression system.

PubMed

Inui, Hideyuki; Gion, Keiko; Utani, Yasushi; Wakai, Taketo; Kodama, Susumu; Eun, Heesoo; Kim, Yun-Seok; Ohkawa, Hideo

2012-01-01

The transgenic tobacco plant XD4V-26 carrying the recombinant mouse aryl hydrocarbon receptor XD4V-mediated β-glucuronidase (GUS) reporter gene expression system was used for assay of dioxins and dioxin-like compounds consisting of polychlorodibenzo-p-dioxins, polychlorinated dibenzofurans, and coplanar polychlorinated biphenyls (Co-PCBs) in actually contaminated soils. The transgenic tobacco plant XD4V-26 showed a significant dose-dependent induced GUS activity when cultured on MS medium containing PCB126 [toxic equivalency factor (TEF) = 0.1]. In contrast, PCB169 and PCB180, which have 0.03 of TEF and unassigned TEF values, respectively, did not significantly induce GUS activity under the same conditions as with PCB126. When the tobacco plants were cultivated for up to 5 weeks on actually contaminated soils with dioxins and dioxin-like compounds collected from the periphery of an incinerator used for disposal of life and industrial wastes, GUS activity in the leaves was dose-dependently increased. The plants clearly detected 360 pg-TEQ g(-1) of dioxins and dioxin-like compounds in this assay. There was a positive correlation between GUS activity and TEQ value of dioxins and dioxin-like compounds in the plants. This assay does not require any extraction and purification processes for the actually contaminated soil samples.

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

PubMed

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

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

PubMed

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

Computer-assisted categorizing of head computed tomography reports for clinical decision rule research.

PubMed

Wall, Stephen P; Mayorga, Oliver; Banfield, Christine E; Wall, Mark E; Aisic, Ilan; Auerbach, Carl; Gennis, Paul

2006-11-01

To develop software that categorizes electronic head computed tomography (CT) reports into groups useful for clinical decision rule research. Data were obtained from the Second National Emergency X-Radiography Utilization Study, a cohort of head injury patients having received head CT. CT reports were reviewed manually for presence or absence of clinically important subdural or epidural hematoma, defined as greater than 1.0 cm in width or causing mass effect. Manual categorization was done by 2 independent researchers blinded to each other's results. A third researcher adjudicated discrepancies. A random sample of 300 reports with radiologic abnormalities was selected for software development. After excluding reports categorized manually or by software as indeterminate (neither positive nor negative), we calculated sensitivity and specificity by using manual categorization as the standard. System efficiency was defined as the percentage of reports categorized as positive or negative, regardless of accuracy. Software was refined until analysis of the training data yielded sensitivity and specificity approximating 95% and efficiency exceeding 75%. To test the system, we calculated sensitivity, specificity, and efficiency, using the remaining 1,911 reports. Of the 1,911 reports, 160 had clinically important subdural or epidural hematoma. The software exhibited good agreement with manual categorization of all reports, including indeterminate ones (weighted kappa 0.62; 95% confidence interval [CI] 0.58 to 0.65). Sensitivity, specificity, and efficiency of the computerized system for identifying manual positives and negatives were 96% (95% CI 91% to 98%), 98% (95% CI 98% to 99%), and 79% (95% CI 77% to 80%), respectively. Categorizing head CT reports by computer for clinical decision rule research is feasible.

A clinical observational study analysing the factors associated with hyperventilation during actual cardiopulmonary resuscitation in the emergency department.

PubMed

Park, Sang O; Shin, Dong Hyuk; Baek, Kwang Je; Hong, Dae Young; Kim, Eun Jung; Kim, Sang Chul; Lee, Kyeong Ryong

2013-03-01

This is the first study to identify the factors associated with hyperventilation during actual cardiopulmonary resuscitation (CPR) in the emergency department (ED). All CPR events in the ED were recorded by video from April 2011 to December 2011. The following variables were analysed using review of the recorded CPR data: ventilation rate (VR) during each minute and its associated factors including provider factors (experience, advanced cardiovascular life support (ACLS) certification), clinical factors (auscultation to confirm successful intubation, suctioning, and comments by the team leader) and time factors (time or day of CPR). Fifty-five adult CPR cases including a total of 673 min sectors were analysed. The higher rates of hyperventilation (VR>10/min) were delivered by inexperienced (53.3% versus 14.2%) or uncertified ACLS provider (52.2% versus 10.8%), during night time (61.0 versus 34.5%) or weekend CPR (53.1% versus 35.6%) and when auscultation to confirm successful intubation was performed (93.5% versus 52.8%) than not (all p<0.0001). However, experienced (25.3% versus 29.7%; p=0.448) or certified ACLS provider (20.6% versus 31.3%; p<0.0001) could not deliver high rate of proper ventilation (VR 8-10/min). Comment by the team leader was most strongly associated with the proper ventilation (odds ratio 7.035, 95% confidence interval 4.512-10.967). Hyperventilation during CPR was associated with inexperienced or uncertified ACLS provider, auscultation to confirm intubation, and night time or weekend CPR. And to deliver proper ventilation, comments by the team leader should be given regardless of providers' expert level. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

A unified approach to the design of clinical reporting systems.

PubMed

Gouveia-Oliveira, A; Salgado, N C; Azevedo, A P; Lopes, L; Raposo, V D; Almeida, I; de Melo, F G

1994-12-01

Computer-based Clinical Reporting Systems (CRS) for diagnostic departments that use structured data entry have a number of functional and structural affinities suggesting that a common software architecture for CRS may be defined. Such an architecture should allow easy expandability and reusability of a CRS. We report the development methodology and the architecture of SISCOPE, a CRS originally designed for gastrointestinal endoscopy that is expandable and reusable. Its main components are a patient database, a knowledge base, a reports base, and screen and reporting engines. The knowledge base contains the description of the controlled vocabulary and all the information necessary to control the menu system, and is easily accessed and modified with a conventional text editor. The structure of the controlled vocabulary is formally presented as an entity-relationship diagram. The screen engine drives a dynamic user interface and the reporting engine automatically creates a medical report; both engines operate by following a set of rules and the information contained in the knowledge base. Clinical experience has shown this architecture to be highly flexible and to allow frequent modifications of both the vocabulary and the menu system. This structure provided increased collaboration among development teams, insulating the domain expert from the details of the database, and enabling him to modify the system as necessary and to test the changes immediately. The system has also been reused in several different domains.

Reliability of Performance-Based Clinical Measurements to Assess Shoulder Girdle Kinematics and Positioning: Systematic Review.

PubMed

D'hondt, Norman E; Kiers, Henri; Pool, Jan J M; Hacquebord, Sijmen T; Terwee, Caroline B; Veeger, Dirkjan H E J

2017-01-01

Deviant shoulder girdle movement is suggested as an eminent factor in the etiology of shoulder pain. Reliable measurements of shoulder girdle kinematics are a prerequisite for optimizing clinical management strategies. The purpose of this study was to evaluate the reliability, measurement error, and internal consistency of measurements with performance-based clinical tests for shoulder girdle kinematics and positioning in patients with shoulder pain. The MEDLINE, Embase, CINAHL, and SPORTDiscus databases were systematically searched from inception to August 2015. Articles published in Dutch, English, or German were included if they involved the evaluation of at least one of the measurement properties of interest. Two reviewers independently evaluated the methodological quality per studied measurement property with the 4-point-rating scale of the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist, extracted data, and assessed the adequacy of the measurement properties. Forty studies comprising more than 30 clinical tests were included. Actual reported measurements of the tests were categorized into: (1) positional measurement methods, (2) measurement methods to determine dynamic characteristics, and (3) tests to diagnose impairments of shoulder girdle function. Best evidence synthesis of the tests was performed per measurement for each measurement property. All studies had significant limitations, including incongruence between test description and actual reported measurements and a lack of reporting on minimal important change. In general, the methodological quality of the selected studies was fair to poor. High-quality evidence indicates that measurements obtained with the Modified Scapular Assistance Test are not reliable for clinical use. Sound recommendations for the use of other tests could not be made due to inadequate evidence. Across studies, diversity in description, performance, and interpretation of similar

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

ERIC Educational Resources Information Center

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…

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

PubMed Central

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

brief report: Burnout Among Early Career Clinical Investigators

PubMed Central

Primack, Brian A.; Dilmore, Terri C.; Switzer, Galen E.; Bryce, Cindy L.; Seltzer, Deborah L.; Li, Jie; Landsittel, Douglas P.; Kapoor, Wishwa N.; Rubio, Doris M.

2010-01-01

Abstract Burnout is a pervasive problem among clinicians. However, little is known about burnout among early career clinical investigators, who must balance clinical responsibilities with challenges related to research. We aimed to determine the prevalence of and demographic associations with burnout in a cohort of early career clinical investigators. A cross‐sectional questionnaire was administered to 179 trainees at the University of Pittsburgh Institute for Clinical Research Education in 2007–2008. We used chi‐square analyses and Fisher’s exact test to determine whether associations between demographic characteristics and burnout were significant. Of the participants, 29 (16%) reported feeling burned out. Burnout was more prevalent among those over 35 years of age relative to their younger counterparts (29% vs. 13%, p= 0.01) and among females relative to males (22% vs. 10%, p= 0.03). With regard to race and ethnicity, burnout was most common among underrepresented minorities (30%) followed by Caucasians (18%) and Asians (3%); these differences were significant (p= 0.02). Considering the early career status of these research trainees, rates of burnout were concerning. Certain demographic subgroups—including older trainees, females, and underrepresented minorities—had particularly high rates of burnout and may benefit from interventions that provide them with skills needed to sustain successful clinical research careers. Clin Trans Sci 2010; Volume 3: 186–188 PMID:20718821

Actual waste demonstration of the nitric-glycolic flowsheet for sludge batch 9 qualification

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

Newell, D.; Pareizs, J.; Martino, C.

For each sludge batch that is processed in the Defense Waste Processing Facility (DWPF), the Savannah River National Laboratory (SRNL) performs qualification testing to demonstrate that the sludge batch is processable. Based on the results of this actual-waste qualification and previous simulant studies, SRNL recommends implementation of the nitric-glycolic acid flowsheet in DWPF. Other recommendations resulting from this demonstration are reported in section 5.0.

Thermal Performance of Cryogenic Piping Multilayer Insulation in Actual Field Installations

NASA Technical Reports Server (NTRS)

Fesmire, J.; Augustnynowicz, S.; Thompson, K. (Technical Monitor)

2002-01-01

A standardized way of comparing the thermal performance of different pipelines in different sizes is needed. Vendor data for vacuum-insulated piping are typically given in heat leak rate per unit length (W/m) for a specific diameter pipeline. An overall k-value for actual field installations (k(sub oafi)) is therefore proposed as a more generalized measure for thermal performance comparison and design calculation. The k(sub oafi) provides a direct correspondence to the k-values reported for insulation materials and illustrates the large difference between ideal multilayer insulation (MLI) and actual MLI performance. In this experimental research study, a section of insulated piping was tested under cryogenic vacuum conditions, including simulated spacers and bending. Several different insulation systems were tested using a 1-meter-long cylindrical cryostat test apparatus. The simulated spacers tests showed significant degradation in the thermal performance of a given insulation system. An 18-meter-long pipeline test apparatus is now in operation at the Cryogenics Test Laboratory, NASA Kennedy Space Center, for conducting liquid nitrogen thermal performance tests.

Electrodermal responses to implied versus actual violence on television.

PubMed

Kalamas, A D; Gruber, M L

1998-01-01

The electrodermal response (EDR) of children watching a violent show was measured. Particular attention was paid to the type of violence (actual or implied) that prompted an EDR. In addition, the impact of the auditory component (sounds associated with violence) of the show was evaluated. Implied violent stimuli, such as the villain's face, elicited the strongest EDR. The elements that elicited the weakest responses were the actual violent stimuli, such as stabbing. The background noise and voices of the sound track enhanced the total number of EDRs. The results suggest that implied violence may elicit more fear (as measured by EDRs) than actual violence does and that sounds alone contribute significantly to the emotional response to television violence. One should not, therefore, categorically assume that a show with mostly actual violence evokes less fear than one with mostly implied violence.

Public Reporting of MRI of the Lumbar Spine for Low Back Pain and Changes in Clinical Documentation.

PubMed

Flug, Jonathan A; Lind, Kimberly E

2017-12-01

OP-8 is the Medicare imaging efficiency metric for MRI of the lumbar spine for low back pain in the outpatient hospital. We studied trends in exclusion criteria coding over time by site of service after implementation of OP-8 to evaluate provider's response to public reporting. We conducted a secondary data analysis using the Medicare Limited Data Set 5% sample for beneficiaries with MRI lumbar spine and lower back pain during 2009 to 2014. We evaluated the association between excluding condition prevalence and site by using generalized estimating equations regression. We produced model-based estimates of excluding condition prevalence by site and year. As a sensitivity analysis, we repeated the analysis while including additional conditions in the outcome measure. We included 285,911 MRIs of the lumbar spine for low back pain. Generalized estimating equations regression found that outpatient hospitals had a higher proportion of MRIs with at least one excluding condition documented compared with outpatient clinics (P < .05), but increases in excluding condition prevalence were similar across all sites during 2009 to 2014. Our results were not sensitive to the inclusion of additional conditions. Documentation of excluding conditions and other clinically reasonable exclusions for OP-8 increased over time for outpatient hospitals and clinics. Increases in documentation of comorbidities may not translate to actual improvement in imaging appropriateness for low back pain. When accounting for all relevant conditions, the proportion of patients with low back pain considered uncomplicated and being measured by OP-8 would be small, reflecting a small proportion of patients with low back pain. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Self-Actualization and the Human Tendency for Varied Experience

ERIC Educational Resources Information Center

Schwartz, Marilyn M.; Gaines, Lawrence S.

1974-01-01

Examines the hypothesis that a significant correlate of self-actualization may be the subjective expression of the tendency towards novelty experiencing and examines the interaction of self-actualization level and specific components of the novelty experiencing construct. (Author/RC)

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

PubMed

Allotey, Pascale; Allotey-Reidpath, Caitlin; Reidpath, Daniel D

2017-01-01

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.

Is talk "cheap"? An initial investigation of the equivalence of alcohol purchase task performance for hypothetical and actual rewards.

PubMed

Amlung, Michael T; Acker, John; Stojek, Monika K; Murphy, James G; MacKillop, James

2012-04-01

Behavioral economic alcohol purchase tasks (APTs) are self-report measures of alcohol demand that assess estimated consumption at escalating levels of price. However, the relationship between estimated performance for hypothetical outcomes and choices for actual outcomes has not been determined. The present study examined both the correspondence between choices for hypothetical and actual outcomes, and the correspondence between estimated alcohol consumption and actual drinking behavior. A collateral goal of the study was to examine the effects of alcohol cues on APT performance. Forty-one heavy-drinking adults (56% men) participated in a human laboratory protocol comprising APTs for hypothetical and actual alcohol and money, an alcohol cue reactivity paradigm, an alcohol self-administration period, and a recovery period. Pearson correlations revealed very high correspondence between APT performance for hypothetical and actual alcohol (ps < 0.001). Estimated consumption on the APT was similarly strongly associated with actual consumption during the self-administration period (r = 0.87, p < 0.001). Exposure to alcohol cues significantly increased subjective craving and arousal and had a trend-level effect on intensity of demand, in spite of notable ceiling effects. Associations among motivational indices were highly variable, suggesting multidimensionality. These results suggest there may be close correspondence both between value preferences for hypothetical alcohol and actual alcohol, and between estimated consumption and actual consumption. Methodological considerations and priorities for future studies are discussed. Copyright © 2011 by the Research Society on Alcoholism.

Adolescents' attitudes toward antimarijuana ads, usage intentions, and actual marijuana usage.

PubMed

Alvaro, Eusebio M; Crano, William D; Siegel, Jason T; Hohman, Zachary; Johnson, Ian; Nakawaki, Brandon

2013-12-01

The association of adolescents' appraisals of the antimarijuana TV ads used in the National Youth Antidrug Media Campaign with future marijuana use was investigated. The 12- to 18-year-old respondents (N = 2,993) were first classified as users, resolute nonusers, or vulnerable nonusers (Crano, Siegel, Alvaro, Lac, & Hemovich, 2008). Usage status and the covariates of gender, age, and attitudes toward marijuana were used to predict attitudes toward the ads (Aad) in the first phase of a multilevel linear analysis. All covariates were significantly associated with Aad, as was usage status: Resolute nonusers evaluated the ads significantly more positively than vulnerable nonusers and users (all ps < .001), who did not differ. In the second phase, the covariates along with Aad and respondents' usage status predicted intentions and actual usage 1 year after initial measurement. The lagged analysis disclosed negative associations between Aad and usage intentions and between Aad and actual marijuana use (both ps < .05); however, this association held only for users (p < .01), not vulnerable or resolute nonusers. Users who reported more positive attitudes toward the ads were less likely to report intention to use marijuana and to continue marijuana use at 1-year follow-up. These findings may inform designers of persuasion-based prevention campaigns, guiding preimplementation efforts in the design of ads that targeted groups find appealing and thus, influential. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Using Patient-Reported Information to Improve Clinical Practice.

PubMed

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

Consistency across Repeated Eyewitness Interviews: Contrasting Police Detectives’ Beliefs with Actual Eyewitness Performance

PubMed Central

Krix, Alana C.; Sauerland, Melanie; Lorei, Clemens; Rispens, Imke

2015-01-01

In the legal system, inconsistencies in eyewitness accounts are often used to discredit witnesses’ credibility. This is at odds with research findings showing that witnesses frequently report reminiscent details (details previously unrecalled) at an accuracy rate that is nearly as high as for consistently recalled information. The present study sought to put the validity of beliefs about recall consistency to a test by directly comparing them with actual memory performance in two recall attempts. All participants watched a film of a staged theft. Subsequently, the memory group (N = 84) provided one statement immediately after the film (either with the Self-Administered Interview or free recall) and one after a one-week delay. The estimation group (N = 81) consisting of experienced police detectives estimated the recall performance of the memory group. The results showed that actual recall performance was consistently underestimated. Also, a sharp decline of memory performance between recall attempts was assumed by the estimation group whereas actual accuracy remained stable. While reminiscent details were almost as accurate as consistent details, they were estimated to be much less accurate than consistent information and as inaccurate as direct contradictions. The police detectives expressed a great concern that reminiscence was the result of suggestive external influences. In conclusion, it seems that experienced police detectives hold many implicit beliefs about recall consistency that do not correspond with actual recall performance. Recommendations for police trainings are provided. These aim at fostering a differentiated view on eyewitness performance and the inclusion of more comprehensive classes on human memory structure. PMID:25695428

Consistency across repeated eyewitness interviews: contrasting police detectives' beliefs with actual eyewitness performance.

PubMed

Krix, Alana C; Sauerland, Melanie; Lorei, Clemens; Rispens, Imke

2015-01-01

In the legal system, inconsistencies in eyewitness accounts are often used to discredit witnesses' credibility. This is at odds with research findings showing that witnesses frequently report reminiscent details (details previously unrecalled) at an accuracy rate that is nearly as high as for consistently recalled information. The present study sought to put the validity of beliefs about recall consistency to a test by directly comparing them with actual memory performance in two recall attempts. All participants watched a film of a staged theft. Subsequently, the memory group (N = 84) provided one statement immediately after the film (either with the Self-Administered Interview or free recall) and one after a one-week delay. The estimation group (N = 81) consisting of experienced police detectives estimated the recall performance of the memory group. The results showed that actual recall performance was consistently underestimated. Also, a sharp decline of memory performance between recall attempts was assumed by the estimation group whereas actual accuracy remained stable. While reminiscent details were almost as accurate as consistent details, they were estimated to be much less accurate than consistent information and as inaccurate as direct contradictions. The police detectives expressed a great concern that reminiscence was the result of suggestive external influences. In conclusion, it seems that experienced police detectives hold many implicit beliefs about recall consistency that do not correspond with actual recall performance. Recommendations for police trainings are provided. These aim at fostering a differentiated view on eyewitness performance and the inclusion of more comprehensive classes on human memory structure.

Reporting of sample size calculations in analgesic clinical trials: ACTTION systematic review.

PubMed

McKeown, Andrew; Gewandter, Jennifer S; McDermott, Michael P; Pawlowski, Joseph R; Poli, Joseph J; Rothstein, Daniel; Farrar, John T; Gilron, Ian; Katz, Nathaniel P; Lin, Allison H; Rappaport, Bob A; Rowbotham, Michael C; Turk, Dennis C; Dworkin, Robert H; Smith, Shannon M

2015-03-01

Sample size calculations determine the number of participants required to have sufficiently high power to detect a given treatment effect. In this review, we examined the reporting quality of sample size calculations in 172 publications of double-blind randomized controlled trials of noninvasive pharmacologic or interventional (ie, invasive) pain treatments published in European Journal of Pain, Journal of Pain, and Pain from January 2006 through June 2013. Sixty-five percent of publications reported a sample size calculation but only 38% provided all elements required to replicate the calculated sample size. In publications reporting at least 1 element, 54% provided a justification for the treatment effect used to calculate sample size, and 24% of studies with continuous outcome variables justified the variability estimate. Publications of clinical pain condition trials reported a sample size calculation more frequently than experimental pain model trials (77% vs 33%, P < .001) but did not differ in the frequency of reporting all required elements. No significant differences in reporting of any or all elements were detected between publications of trials with industry and nonindustry sponsorship. Twenty-eight percent included a discrepancy between the reported number of planned and randomized participants. This study suggests that sample size calculation reporting in analgesic trial publications is usually incomplete. Investigators should provide detailed accounts of sample size calculations in publications of clinical trials of pain treatments, which is necessary for reporting transparency and communication of pre-trial design decisions. In this systematic review of analgesic clinical trials, sample size calculations and the required elements (eg, treatment effect to be detected; power level) were incompletely reported. A lack of transparency regarding sample size calculations may raise questions about the appropriateness of the calculated sample size. Copyright

Using phrases and document metadata to improve topic modeling of clinical reports.

PubMed

Speier, William; Ong, Michael K; Arnold, Corey W

2016-06-01

Probabilistic topic models provide an unsupervised method for analyzing unstructured text, which have the potential to be integrated into clinical automatic summarization systems. Clinical documents are accompanied by metadata in a patient's medical history and frequently contains multiword concepts that can be valuable for accurately interpreting the included text. While existing methods have attempted to address these problems individually, we present a unified model for free-text clinical documents that integrates contextual patient- and document-level data, and discovers multi-word concepts. In the proposed model, phrases are represented by chained n-grams and a Dirichlet hyper-parameter is weighted by both document-level and patient-level context. This method and three other Latent Dirichlet allocation models were fit to a large collection of clinical reports. Examples of resulting topics demonstrate the results of the new model and the quality of the representations are evaluated using empirical log likelihood. The proposed model was able to create informative prior probabilities based on patient and document information, and captured phrases that represented various clinical concepts. The representation using the proposed model had a significantly higher empirical log likelihood than the compared methods. Integrating document metadata and capturing phrases in clinical text greatly improves the topic representation of clinical documents. The resulting clinically informative topics may effectively serve as the basis for an automatic summarization system for clinical reports. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed Central

Kunimitsu, Ayano

2009-01-01

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 government statistics in

Research information knowledge, perceived adequacy, and understanding in cancer clinical trial participants.

PubMed

Biedrzycki, Barbara A

2011-07-01

To describe the adequacy of research information among people with cancer at the time they accept or decline participation in a cancer clinical trial. Cross-sectional, descriptive. An urban, academic, National Cancer Institute-designated comprehensive cancer center. 197 patients with advanced gastrointestinal cancer. Mailed survey; self-reported data. Adequacy of research information (actual knowledge, perceived adequacy of information, and perceived understanding), cancer clinical trial participation, and satisfaction with the decision to participate. Most respondents (88%) perceived themselves as having adequate information to make an informed decision regarding cancer clinical trial participation. In addition, 35% demonstrated adequate knowledge of basic clinical research. Patients decide to accept or decline cancer clinical trials without having adequate knowledge. Nurses have an important role in educating patients regarding cancer clinical trials. The ideal teachable moment may not occur at the time of diagnosis; other less stressful opportunities may present when the patient is more receptive.

Extensible Stylesheet Language Formatting Objects (XSL-FO): a tool to transform patient data into attractive clinical reports.

PubMed

Simonaitis, Linas; Belsito, Anne; Warvel, Jeff; Hui, Siu; McDonald, Clement J

2006-01-01

Clinicians at Wishard Hospital in Indianapolis print and carry clinical reports called "Pocket Rounds". This paper describes a new process we developed to improve these clinical reports. The heart of our new process is a World Wide Web Consortium standard: Extensible Stylesheet Language Formatting Objects (XSL-FO). Using XSL-FO stylesheets we generated Portable Document Format (PDF) and PostScript reports with complex formatting: columns, tables, borders, shading, indents, dividing lines. We observed patterns of clinical report printing during a eight month study period on three Medicine wards. Usage statistics indicated that clinicians accepted the new system enthusiastically: 78% of 26,418 reports were printed using the new system. We surveyed 67 clinical users. Respondents gave the new reports a rating of 4.2 (on a 5 point scale); they gave the old reports a rating of 3.4. The primary complaint was that it took longer to print the new reports. We believe that XSL-FO is a promising way to transform text data into functional and attractive clinical reports: relatively easy to implement and modify.

Comparing Determinants of Perceived and Actual Recycling Skills: The Role of Motivational, Behavioral and Dispositional Factors

ERIC Educational Resources Information Center

Passafaro, Paola; Livi, Stefano

2017-01-01

An empirical investigation assessed the role of different factors of motivational, behavioral, and dispositional nature in the prediction of both perceived and actual skills concerning household waste recycling. A structured questionnaire (measuring attitudes, social norms, perceived control, need for cognitive closure, self-reported household…

Report of a new case and clinical delineation of mosaic trisomy 9 syndrome

PubMed Central

Sánchez, José María; Fijtman, Nora; Migliorini, Ana María

1982-01-01

A newborn girl with trisomy 9 mosaicism is reported. Clinical findings included major malformations: bilateral hip dislocation, dislocation of the left knee, extreme micrognathia, and microsomy. Up to date, 11 liveborn infants with trisomy 9 have been reported, which allows us to make a karyotype/phenotype correlation. Minimal clinical diagnostic criteria are defined, on the basis of which the presence of this syndrome can be suspected. Images PMID:7143394

Clinical Training in Aging and Mental Health. Final Report.

ERIC Educational Resources Information Center

Gatz, Margaret; And Others

This report describes the University of Southern California's (USC) gerontology career preparation project, which was funded for the following training activities in mental health and aging: (1) traineeships for graduate students in USC's doctoral track in clinical psychology and aging and in the Leonard Davis School of Gerontology master's track…

The Self-Actualizing Case Method.

ERIC Educational Resources Information Center

Gunn, Bruce

1980-01-01

Presents a case procedure designed to assist trainees in perfecting their problem-solving skills. Elements of that procedure are the rationale behind this "self-actualizing" case method; the role that the instructor, case leaders, and participants play in its execution; and the closed-loop grading system used for peer evaluation. (CT)

Linguistic Theory and Actual Language.

ERIC Educational Resources Information Center

Segerdahl, Par

1995-01-01

Examines Noam Chomsky's (1957) discussion of "grammaticalness" and the role of linguistics in the "correct" way of speaking and writing. It is argued that the concern of linguistics with the tools of grammar has resulted in confusion, with the tools becoming mixed up with the actual language, thereby becoming the central…

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

PubMed

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

Assays of dioxins and dioxin-like compounds in actually contaminated soils using transgenic tobacco plants carrying a recombinant mouse aryl hydrocarbon receptor-mediated β-glucuronidase reporter gene expression system

PubMed Central

Inui, Hideyuki; Gion, Keiko; Utani, Yasushi; Wakai, Taketo; Kodama, Susumu; Eun, Heesoo; Kim, Yun-Seok; Ohkawa, Hideo

2012-01-01

The transgenic tobacco plant XD4V-26 carrying the recombinant mouse aryl hydrocarbon receptor XD4V-mediated β-glucuronidase (GUS) reporter gene expression system was used for assay of dioxins and dioxin-like compounds consisting of polychlorodibenzo-p-dioxins, polychlorinated dibenzofurans, and coplanar polychlorinated biphenyls (Co-PCBs) in actually contaminated soils. The transgenic tobacco plant XD4V-26 showed a significant dose-dependent induced GUS activity when cultured on MS medium containing PCB126 [toxic equivalency factor (TEF) = 0.1]. In contrast, PCB169 and PCB180, which have 0.03 of TEF and unassigned TEF values, respectively, did not significantly induce GUS activity under the same conditions as with PCB126. When the tobacco plants were cultivated for up to 5 weeks on actually contaminated soils with dioxins and dioxin-like compounds collected from the periphery of an incinerator used for disposal of life and industrial wastes, GUS activity in the leaves was dose-dependently increased. The plants clearly detected 360 pg-TEQ g−1 of dioxins and dioxin-like compounds in this assay. There was a positive correlation between GUS activity and TEQ value of dioxins and dioxin-like compounds in the plants. This assay does not require any extraction and purification processes for the actually contaminated soil samples. PMID:22428884

A nurse- and pharmacist-led treatment advice clinic for patients attending an HIV outpatient clinic.

PubMed

Griffiths, C; Miles, K; Aldam, D; Cornforth, D; Minton, J; Edwards, S; Williams, I

2007-05-01

This paper is a report of a study to map care pathways, examine the approach of different treatment advisors and explore the acceptability of a nurse- and pharmacist-led treatment advice clinic in order to aid decision-making for the future development and evaluation of the clinic. High levels of adherence to antiretroviral drugs are a prerequisite for a successful and durable virological and immunological response to HIV. Treatment guidelines acknowledge that adherence is a process, not a single event, and that adherence support must be integrated into clinical follow-up for all patients receiving these drugs. Data were collected between September 2004 and January 2005 through 17 consultation observations and 10 patient interviews in a specialist treatment advice clinic located within a central London HIV outpatient clinic providing care for over 2200 patients, of whom more than 1300 are taking highly active antiretroviral therapy. The nurses and pharmacist had similar consultation approaches, although follow-up care varied in extent. Benefits of the clinic approach included permitting patients to observe real tablets, tailoring regimens to lifestyles and telephone follow-up. These factors, particularly telephone support, were perceived by patients to assist with adherence. The role of telephone support, perceived to assist with initial adherence, requires further investigation. Future work is also needed to explore the health economics of this approach and to determine the actual impact of the clinic on clinical and adherence outcomes.

Clinical learning experiences of nursing students using an innovative clinical partnership model: A non-randomized controlled trial.

PubMed

Chan, Aileen W K; Tang, Fiona W K; Choi, Kai Chow; Liu, Ting; Taylor-Piliae, Ruth E

2018-06-05

Clinical practicum is a major learning component for pre-registration nursing students. Various clinical practicum models have been used to facilitate students' clinical learning experiences, employing both university-based and hospital-based clinical teachers. Considering the strengths and limitations of these clinical practicum models, along with nursing workforce shortages, we developed and tested an innovative clinical partnership model (CPM) in Hong Kong. To evaluate an innovative CPM among nursing students actual and preferred clinical learning environment, compared with a conventional facilitation model (CFM). A non-randomized controlled trial examining students' clinical experiences, comparing the CPM (supervised by hospital clinical teacher) with the CFM (supervised by university clinical teacher). One university in Hong Kong. Pre-registration nursing students (N = 331), including bachelor of nursing (n = 246 year three-BN) and masters-entry nursing (n = 85 year one-MNSP). Students were assigned to either the CPM (n = 48 BN plus n = 85 MNSP students) or the CFM (n = 198 BN students) for their clinical practice experiences in an acute medical-surgical ward. Clinical teachers supervised between 6 and 8 students at a time, during these clinical practicums (duration = 4-6 weeks). At the end of the clinical practicum, students were invited to complete the Clinical Learning Environment Inventory (CLEI). Analysis of covariance was used to compare groups; adjusted for age, gender and prior work experience. A total of 259 students (mean age = 22 years, 76% female, 81% prior work experience) completed the CLEI (78% response rate). Students had higher scores on preferred versus actual experiences, in all domains of the CLEI. CPM student experiences indicated a higher preferred task orientation (p = 0.004), while CFM student experiences indicated a higher actual (p < 0.001) and preferred individualization (p = 0

Reporting of statistically significant results at ClinicalTrials.gov for completed superiority randomized controlled trials.

PubMed

Dechartres, Agnes; Bond, Elizabeth G; Scheer, Jordan; Riveros, Carolina; Atal, Ignacio; Ravaud, Philippe

2016-11-30

Publication bias and other reporting bias have been well documented for journal articles, but no study has evaluated the nature of results posted at ClinicalTrials.gov. We aimed to assess how many randomized controlled trials (RCTs) with results posted at ClinicalTrials.gov report statistically significant results and whether the proportion of trials with significant results differs when no treatment effect estimate or p-value is posted. We searched ClinicalTrials.gov in June 2015 for all studies with results posted. We included completed RCTs with a superiority hypothesis and considered results for the first primary outcome with results posted. For each trial, we assessed whether a treatment effect estimate and/or p-value was reported at ClinicalTrials.gov and if yes, whether results were statistically significant. If no treatment effect estimate or p-value was reported, we calculated the treatment effect and corresponding p-value using results per arm posted at ClinicalTrials.gov when sufficient data were reported. From the 17,536 studies with results posted at ClinicalTrials.gov, we identified 2823 completed phase 3 or 4 randomized trials with a superiority hypothesis. Of these, 1400 (50%) reported a treatment effect estimate and/or p-value. Results were statistically significant for 844 trials (60%), with a median p-value of 0.01 (Q1-Q3: 0.001-0.26). For the 1423 trials with no treatment effect estimate or p-value posted, we could calculate the treatment effect and corresponding p-value using results reported per arm for 929 (65%). For 494 trials (35%), p-values could not be calculated mainly because of insufficient reporting, censored data, or repeated measurements over time. For the 929 trials we could calculate p-values, we found statistically significant results for 342 (37%), with a median p-value of 0.19 (Q1-Q3: 0.005-0.59). Half of the trials with results posted at ClinicalTrials.gov reported a treatment effect estimate and/or p-value, with significant

Adolescents’ Attitudes toward Anti-marijuana Ads, Usage Intentions, and Actual Marijuana Usage

PubMed Central

Alvaro, Eusebio M.; Crano, William D.; Siegel, Jason T.; Hohman, Zachary; Johnson, Ian; Nakawaki, Brandon

2015-01-01

The association of adolescents’ appraisals of the anti-marijuana television ads used in the National Youth Anti-drug Media Campaign with future marijuana use was investigated. The 12 to 18 year old respondents (N = 2993) were first classified as users, resolute nonusers, or vulnerable nonusers (Crano, Siegel, Alvaro, Lac, & Hemovich, 2008). Usage status and the covariates of gender, age, and attitudes toward marijuana were used to predict attitudes toward the ads (Aad) in the first phase of a multi-level linear analysis. All covariates were significantly associated with Aad, as was usage status: resolute nonusers evaluated the ads significantly more positively than vulnerable nonusers and users (all p < .001), who did not differ. In the second phase, the covariates along with Aad and respondents’ usage status predicted intentions and actual usage one year after initial measurement. The lagged analysis disclosed negative associations between Aad and usage intentions, and between Aad and actual marijuana use (both p < .05); however, this association held only for users (p < .01), not vulnerable or resolute nonusers. Users reporting more positive attitudes towards the ads were less likely to report intention to use marijuana and to continue marijuana use at 1-year follow-up. These findings may inform designers of persuasion-based prevention campaigns, guiding pre-implementation efforts in the design of ads that targeted groups find appealing and thus, influential. PMID:23528197

Moving toward the reduction of publication/reporting biases in clinical trials using a new international standard.

PubMed

Doi, Yuriko

2016-01-01

Evidence-based medicine (EBM) is fundamental to ensuring high-quality medical care. It requires systematic reviews and meta-analyses to synthesize diverse information available from individual clinical studies. However, the literature reviewed may represent an incomplete and selective set of research findings, which could lead to publication/reporting biases and distort the true picture of research as a whole. Prospective registry of all clinical trials in the world is mandatory to reduce the biases, which have been disclosed on the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (WHO) since 2007. The Japan Primary Registries Network (JPRN) is included in the ICTRP. ClinicalTrials.gov, the U.S. clinical trial registry, reports the standardized data of registered trials and offers access to submitted outcomes online. However, the JPRN does not systematically include the outcomes. On April 14, 2015, the WHO published a new statement online on the public disclosure of clinical trial results, which requires researchers to define the timeframes of reporting main findings and key outcomes, to call for results-reporting older, but still unpublished trials, and to outline steps to improve linkages between clinical trial registry entries and their published results. The WHO's new position will facilitate global efforts to reduce publication/reporting biases in clinical trials. Japan will have to actively participate in these efforts as well.

A logical foundation for representation of clinical data.

PubMed Central

Campbell, K E; Das, A K; Musen, M A

1994-01-01

OBJECTIVE: A general framework for representation of clinical data that provides a declarative semantics of terms and that allows developers to define explicitly the relationships among both terms and combinations of terms. DESIGN: Use of conceptual graphs as a standard representation of logic and of an existing standardized vocabulary, the Systematized Nomenclature of Medicine (SNOMED International), for lexical elements. Concepts such as time, anatomy, and uncertainty must be modeled explicitly in a way that allows relation of these foundational concepts to surface-level clinical descriptions in a uniform manner. RESULTS: The proposed framework was used to model a simple radiology report, which included temporal references. CONCLUSION: Formal logic provides a framework for formalizing the representation of medical concepts. Actual implementations will be required to evaluate the practicality of this approach. PMID:7719805

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

PubMed

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

Second thoughts on the final rule: An analysis of baseline participant characteristics reports on ClinicalTrials.gov.

PubMed

Cahan, Amos; Anand, Vibha

2017-01-01

ClinicalTrials.gov is valuable for aggregate-level analysis of trials. The recently published final rule aims to improve reporting of trial results. We aimed to assess variability in ClinicalTirals.gov records reporting participants' baseline measures. The September 2015 edition of the database for Aggregate Analysis of ClinicalTrials.gov (AACT), was used in this study. To date, AACT contains 186,941 trials of which 16,660 trials reporting baseline (participant) measures were analyzed. We also analyzed a subset of 13,818 Highly Likely Applicable Clinical Trials (HLACT), for which reporting of results is likely mandatory and compared a random sample of 30 trial records to their journal articles. We report counts for each mandatory baseline measure and variability reporting in their formats. The AACT dataset contains 8,161 baseline measures with 1206 unique measurement units. However, of these 6,940 (85%) variables appear only once in the dataset. Age and Gender are reported using many different formats (178 and 49 respectively). "Age" as the variable name is reported in 60 different formats. HLACT subset reports measures using 3,931 variables. The most frequent Age format (i.e. mean (years) ± sd) is found in only 45% of trials. Overall only 4 baseline measures (Region of Enrollment, Age, Number of Participants, and Gender) are reported by > 10% of trials. Discrepancies are found in both the types and formats of ClinicalTrials.gov records and their corresponding journal articles. On average, journal articles include twice the number of baseline measures (13.6±7.1 (sd) vs. 6.6±7.6) when compared to the ClinicalTrials.gov records that report any results. We found marked variability in baseline measures reporting. This is not addressed by the final rule. To support secondary use of ClinicalTrials.gov, a uniform format for baseline measures reporting is warranted.

Effective Information Extraction Framework for Heterogeneous Clinical Reports Using Online Machine Learning and Controlled Vocabularies

PubMed Central

Zheng, Shuai; Ghasemzadeh, Nima; Hayek, Salim S; Quyyumi, Arshed A

2017-01-01

Background Extracting structured data from narrated medical reports is challenged by the complexity of heterogeneous structures and vocabularies and often requires significant manual effort. Traditional machine-based approaches lack the capability to take user feedbacks for improving the extraction algorithm in real time. Objective Our goal was to provide a generic information extraction framework that can support diverse clinical reports and enables a dynamic interaction between a human and a machine that produces highly accurate results. Methods A clinical information extraction system IDEAL-X has been built on top of online machine learning. It processes one document at a time, and user interactions are recorded as feedbacks to update the learning model in real time. The updated model is used to predict values for extraction in subsequent documents. Once prediction accuracy reaches a user-acceptable threshold, the remaining documents may be batch processed. A customizable controlled vocabulary may be used to support extraction. Results Three datasets were used for experiments based on report styles: 100 cardiac catheterization procedure reports, 100 coronary angiographic reports, and 100 integrated reports—each combines history and physical report, discharge summary, outpatient clinic notes, outpatient clinic letter, and inpatient discharge medication report. Data extraction was performed by 3 methods: online machine learning, controlled vocabularies, and a combination of these. The system delivers results with F1 scores greater than 95%. Conclusions IDEAL-X adopts a unique online machine learning–based approach combined with controlled vocabularies to support data extraction for clinical reports. The system can quickly learn and improve, thus it is highly adaptable. PMID:28487265

Nominal vs. actual supersaturation of solutions

NASA Astrophysics Data System (ADS)

Borisenko, Alexander

2018-03-01

Following the formalism of the Classical Nucleation Theory beyond the dilute solution approximation, this paper considers a difference between the actual solute supersaturation (given by the present-to-saturated solute activity ratio) and the nominal supersaturation (given by the present-to-saturated solute concentration ratio) due to formation of subcritical transient solute clusters, called heterophase fluctuations. Based on their distribution function, we introduce an algebraic equation of supersaturation that couples the nominal supersaturation of a binary metastable solution with its actual supersaturation and a function of the specific interface energy and temperature. The applicability of this approach is validated by comparison to simulation data [(Clouet et al., Phys. Rev. B 69, 064109 (2004)] on nucleation of Al3Zr and Al3Sc in model binary Al alloys.

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

PubMed

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

Self-Actualization in a Marathon Growth Group: Do the Strong Get Stronger?

ERIC Educational Resources Information Center

Kimball, Ronald; Gelso, Charles J.

1974-01-01

This study examined the effects of a weekend marathon on the level of self-actualization of college students and the relationship between ego strength and extent of change in self-actualization. The group experience did increase self-actualization, but participants' initial level of ego strength was unrelated to changes in self-actualization.…

Does routinely collected patient-reported outcome data represent the actual case-mix of elective coronary revascularization patients?

PubMed

Oinasmaa, Salla; Heiskanen, Jari; Hartikainen, Juha; Hippeläinen, Mikko; Miettinen, Heikki; Martikainen, Janne; Roine, Risto P; Tolppanen, Anna-Maija

2018-04-01

Patient-reported outcomes (PROs) are valuable for effectiveness evaluation, but it is unknown whether the patient views obtained represent the actual case mix. We studied the representativeness of the responses obtained to a routinely administered health-related quality of life (HRQoL) questionnaire in a cardiology unit. Elective coronary artery bypass grafting (CABG; n = 404) and percutaneous coronary intervention (PCI; n = 738) patients operated during June 2012 to August 2014 in the Heart Center, Kuopio University Hospital. The characteristics of the patients with a baseline (n = 260 and 290 for CABG and PCI, respectively) or both baseline and follow-up HRQoL measurements (n = 203 and 189 for CABG and PCI, respectively) were compared with those who did not respond (n = 144 and 448 for CABG and PCI). Baseline questionnaires were less likely obtained from older CABG patients (odds ratio 0.51, 95% confidence interval 0.28-0.91) and those with more severe disease (0.20, 0.05-0.79). Among PCI patients, women (0.64, 0.45-0.91), smokers (0.74, 0.53-1.04), and those with more severe disease (0.26, 0.13-0.52) or more hospital days were underrepresented. Routinely collected PROs in cardiac patients may be biased towards younger and healthier patients. This needs to be recognized when evaluating the representativeness of such data. The routine collection of these data should be adequately resourced.

Adverse event reporting in cancer clinical trial publications.

PubMed

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.

Preparing for practice: Nursing intern and faculty perceptions on clinical experiences.

PubMed

AlThiga, Hanan; Mohidin, Sharifah; Park, Yoon Soo; Tekian, Ara

2017-04-01

Clinical experience and exposure to real patients are required elements of nursing education. Trainees in nursing are expected to be prepared adequately for the hard-working environment, increasing patient complexity, and higher-level competencies. This study investigates differences between nursing interns and clinical faculty on actual and perceived importance of educational preparation and development of clinical competencies, focusing on the nursing curriculum and transition to practice. A convenient sampling technique with a mixed-methods design was used to collect quantitative and qualitative data, by surveying and interviewing nursing interns and faculty members from King Abdul-Aziz University in Saudi Arabia; data collection occurred in December 2015. The survey (23 items) and focused interviews measured perceptions of clinical instruction and experience. Descriptive statistics and t-tests were used to analyze differences in mean ratings between actual and perceived importance. Themes collected from narrative interview data were summarized. Significant differences were found between nursing interns (n = 46) and faculty (n = 29) perceptions of actual clinical teaching and experiences and its importance including the clinical teaching and the development of clinical competence, p < .01. Moreover, nursing interns rated actual experiences of knowledge base and skills significantly lower than faculty perceptions, p = .001. Narrative data provided in-depth information on factors contributing and hindering the learning and teaching environment. Findings from this study call for clinical instruction and experiences to take a step further to meet current practice standards and to improve patient safety in the health professions education of nurses.

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

PubMed

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.

Self-actualization: Its Use and Misuse in Teacher Education.

ERIC Educational Resources Information Center

Ivie, Stanley D.

1982-01-01

The writings of Abraham Maslow are analyzed to determine the meaning of the psychological term "self-actualization." After pointing out that self-actualization is a rare quality and that it has little to do with formal education, the author concludes that the concept has little practical relevance for teacher education. (PP)

Case Studies of Self-Actualization.

ERIC Educational Resources Information Center

Brennan, Thomas P.; Piechowski, Michael M.

Case studies of self-actualizing people according to the ideas of A. Maslow and the criteria of K. Dabrowski are presented. To find people meeting the criteria of Level 4 of the Dabrowski theory, a pool of 21 subjects was established by nomination. All subjects were given the Definition-Response Instrument to assess levels of emotional…

7 CFR 400.55 - Qualification for actual production history coverage program.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 6 2014-01-01 2014-01-01 false Qualification for actual production history coverage... Production History § 400.55 Qualification for actual production history coverage program. (a) The approved... history is certified and T or D-Yields are not provided in the actuarial documents, (2) If actual yield...

A taxometric analysis of actual Internet sports gambling behavior.

PubMed

Braverman, Julia; LaBrie, Richard A; Shaffer, Howard J

2011-03-01

This article presents findings from the first taxometric study of actual gambling behavior to determine whether we can represent the characteristics of extreme gambling as qualitatively distinct (i.e., taxonic) or as a point along a dimension. We analyzed the bets made during a 24-month study period by the 4,595 most involved gamblers among a cohort of 48,114 people using an Internet service to gamble on sporting events. We applied two taxometric procedures (i.e., MAMBAC and MAXCOV) to three indicators of betting behavior: total money lost, total number of bets, and total money wagered. The results fail to provide support for the view that the most involved Internet sports gamblers include a distinct category of gamblers. More research is necessary to clarify the similar features of recreational and extreme gamblers and the dimensions that scientists can use to measure these behaviors. Finally, we discuss the implications of these findings for clinical, research, and public policy activities.

Caution regarding the choice of standard deviations to guide sample size calculations in clinical trials.

PubMed

Chen, Henian; Zhang, Nanhua; Lu, Xiaosun; Chen, Sophie

2013-08-01

The method used to determine choice of standard deviation (SD) is inadequately reported in clinical trials. Underestimations of the population SD may result in underpowered clinical trials. This study demonstrates how using the wrong method to determine population SD can lead to inaccurate sample sizes and underpowered studies, and offers recommendations to maximize the likelihood of achieving adequate statistical power. We review the practice of reporting sample size and its effect on the power of trials published in major journals. Simulated clinical trials were used to compare the effects of different methods of determining SD on power and sample size calculations. Prior to 1996, sample size calculations were reported in just 1%-42% of clinical trials. This proportion increased from 38% to 54% after the initial Consolidated Standards of Reporting Trials (CONSORT) was published in 1996, and from 64% to 95% after the revised CONSORT was published in 2001. Nevertheless, underpowered clinical trials are still common. Our simulated data showed that all minimal and 25th-percentile SDs fell below 44 (the population SD), regardless of sample size (from 5 to 50). For sample sizes 5 and 50, the minimum sample SDs underestimated the population SD by 90.7% and 29.3%, respectively. If only one sample was available, there was less than 50% chance that the actual power equaled or exceeded the planned power of 80% for detecting a median effect size (Cohen's d = 0.5) when using the sample SD to calculate the sample size. The proportions of studies with actual power of at least 80% were about 95%, 90%, 85%, and 80% when we used the larger SD, 80% upper confidence limit (UCL) of SD, 70% UCL of SD, and 60% UCL of SD to calculate the sample size, respectively. When more than one sample was available, the weighted average SD resulted in about 50% of trials being underpowered; the proportion of trials with power of 80% increased from 90% to 100% when the 75th percentile and the

Clinical Outcome Reporting in Youth ACL Literature Is Widely Variable

PubMed Central

Brusalis, Christopher M.; Lakomkin, Nikita; Suryavanshi, Joash R.; Cruz, Aristides I.; Green, Daniel W.; Jones, Kristofer J.; Fabricant, Peter D.

2017-01-01

Background: Advances in anterior cruciate ligament (ACL) reconstruction procedures in pediatric and adolescent patients have resulted in an increase in recent clinical studies on this topic. However, the consistency with which outcome measures are reported in this demographic is unknown. Purpose: To document outcome reporting patterns of youth ACL reconstruction studies in high-impact journals. Study Design: Systematic review; Level of evidence, 4. Methods: All articles published in 5 high-impact orthopaedic journals from 2010 to 2016 were reviewed to identify those reporting clinical outcomes of young patients who underwent ACL reconstruction. Studies that were nonclinical, reported on patients older than 18 years, or included fewer than 10 patients were excluded. Outcome measures used in all included studies were recorded. Results: Seventeen studies encompassing 772 subjects (mean age, 14.3 years; range, 6.3-18.0 years) were analyzed. Eight studies (47%) reported on Tanner stage of subjects, while 1 study reported skeletal age. Ten studies (59%) clearly documented the presence or absence of surgical complications. Range of motion was reported in 65% of studies. Leg-length discrepancy and angular deformity were each reported in 76% of studies, with 12% quantifying results through radiographic measurements. Ligament testing was variably defined by inclusion of instrumented testing (65%), Lachman test (53%), and pivot-shift test (53%). Fourteen studies (82%) explicitly reported on the rate of ACL rerupture, while 71% reported on the rate of revision surgery. Rate of return to preinjury activity was reported in 8 studies (47%), of which 2 defined criteria for return to sport and 3 defined the level of competitive sport. Patient-reported outcome measures (PROMs) were used variably. For the 3 most commonly reported PROMs (Lysholm, International Knee Documentation Committee, and Tegner), 24% of studies reported all 3 PROMs, 35% of studies reported 2 PROMs, and 6% of

Discrete-event computer simulation methods in the optimisation of a physiotherapy clinic.

PubMed

Villamizar, J R; Coelli, F C; Pereira, W C A; Almeida, R M V R

2011-03-01

To develop a computer model to analyse the performance of a standard physiotherapy clinic in the city of Rio de Janeiro, Brazil. The clinic receives an average of 80 patients/day and offers 10 treatment modalities. Details of patient procedures and treatment routines were obtained from direct interviews with clinic staff. Additional data (e.g. arrival time, treatment duration, length of stay) were obtained for 2000 patients from the clinic's computerised records from November 2005 to February 2006. A discrete-event model was used to simulate the clinic's operational routine. The initial model was built to reproduce the actual configuration of the clinic, and five simulation strategies were subsequently implemented, representing changes in the number of patients, human resources of the clinic and the scheduling of patient arrivals. Findings indicated that the actual clinic configuration could accept up to 89 patients/day, with an average length of stay of 119minutes and an average patient waiting time of 3minutes. When the scheduling of patient arrivals was increased to an interval of 6.5minutes, maximum attendance increased to 114 patients/day. For the actual clinic configuration, optimal staffing consisted of three physiotherapists and 12 students. According to the simulation, the same 89 patients could be attended when the infrastructure was decreased to five kinesiotherapy rooms, two cardiotherapy rooms and three global postural reeducation rooms. The model was able to evaluate the capacity of the actual clinic configuration, and additional simulation strategies indicated how the operation of the clinic depended on the main study variables. Copyright © 2010 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Overestimation Bias in Self-Reported SAT Scores

ERIC Educational Resources Information Center

Mayer, Richard E.; Stull, Andrew T.; Campbell, Julie; Almeroth, Kevin; Bimber, Bruce; Chun, Dorothy; Knight, Allan

2007-01-01

The authors analyzed self-reported SAT scores and actual SAT scores for five different samples of college students (N = 650). Students overestimated their actual SAT scores by an average of 25 points (SD = 81, d = 0.31), with 10% under-reporting, 51% reporting accurately, and 39% over-reporting, indicating a systematic bias towards over-reporting.…

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

PubMed

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.

Effective Information Extraction Framework for Heterogeneous Clinical Reports Using Online Machine Learning and Controlled Vocabularies.

PubMed

Zheng, Shuai; Lu, James J; Ghasemzadeh, Nima; Hayek, Salim S; Quyyumi, Arshed A; Wang, Fusheng

2017-05-09

Extracting structured data from narrated medical reports is challenged by the complexity of heterogeneous structures and vocabularies and often requires significant manual effort. Traditional machine-based approaches lack the capability to take user feedbacks for improving the extraction algorithm in real time. Our goal was to provide a generic information extraction framework that can support diverse clinical reports and enables a dynamic interaction between a human and a machine that produces highly accurate results. A clinical information extraction system IDEAL-X has been built on top of online machine learning. It processes one document at a time, and user interactions are recorded as feedbacks to update the learning model in real time. The updated model is used to predict values for extraction in subsequent documents. Once prediction accuracy reaches a user-acceptable threshold, the remaining documents may be batch processed. A customizable controlled vocabulary may be used to support extraction. Three datasets were used for experiments based on report styles: 100 cardiac catheterization procedure reports, 100 coronary angiographic reports, and 100 integrated reports-each combines history and physical report, discharge summary, outpatient clinic notes, outpatient clinic letter, and inpatient discharge medication report. Data extraction was performed by 3 methods: online machine learning, controlled vocabularies, and a combination of these. The system delivers results with F1 scores greater than 95%. IDEAL-X adopts a unique online machine learning-based approach combined with controlled vocabularies to support data extraction for clinical reports. The system can quickly learn and improve, thus it is highly adaptable. ©Shuai Zheng, James J Lu, Nima Ghasemzadeh, Salim S Hayek, Arshed A Quyyumi, Fusheng Wang. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 09.05.2017.

Perceived and actual social discrimination: the case of overweight and social inclusion.

PubMed

Hartung, Freda-Marie; Renner, Britta

2013-01-01

The present study examined the correspondence between perceived and actual social discrimination of overweight people. In total, 77 first-year students provided self-ratings about their height, weight, and perceived social inclusion. To capture actual social inclusion, each participant nominated those fellow students (a) she/he likes and dislikes and (b) about whom she/he is likely to hear social news. Students with lower Body Mass Index (BMI) felt socially included, irrespective of their actual social inclusion. In contrast, students with higher BMI felt socially included depending on the degree of their actual social inclusion. Specifically, their felt social inclusion accurately reflected whether they were actually liked/disliked, but only when they were part of social news. When not part of social news, they also showed insensitivity to their actual social inclusion status. Thus, students with a lower BMI tended to be insensitive, while students with a higher BMI showed a differential sensitivity to actual social discrimination.

Realizing actual feedback control of complex network

NASA Astrophysics Data System (ADS)

Tu, Chengyi; Cheng, Yuhua

2014-06-01

In this paper, we present the concept of feedbackability and how to identify the Minimum Feedbackability Set of an arbitrary complex directed network. Furthermore, we design an estimator and a feedback controller accessing one MFS to realize actual feedback control, i.e. control the system to our desired state according to the estimated system internal state from the output of estimator. Last but not least, we perform numerical simulations of a small linear time-invariant dynamics network and a real simple food network to verify the theoretical results. The framework presented here could make an arbitrary complex directed network realize actual feedback control and deepen our understanding of complex systems.

Marijuana, alcohol and actual driving performance

DOT National Transportation Integrated Search

1999-07-01

The purpose of this study was to empirically determine the separate and combined effects of Delta-9-tetrahydrocannabinol (THC) and alcohol on actual driving performance. This was the first study ever in which the drugs' combined effects were measured...

Association between imagined and actual functional reach (FR): a comparison of young and older adults.

PubMed

Gabbard, Carl; Cordova, Alberto

2013-01-01

Recent studies indicate that the ability to mentally represent action using motor imagery declines with advanced age (>64 years). As the ability to represent action declines, the elderly may experience increasing difficulty with movement planning and execution. Here, we determined the association between estimation of reach via use of motor imagery and actual FR. Young adults (M=22 years) and older adults (M=66 years) estimated reach while standing with targets randomly presented in peripersonal (within actual reach) and extrapersonal (beyond reach) space. Imagined responses were compared to the individual's scaled maximum reach. FR, also while standing, was assessed using the standardized Functional Reach Test (FRT). Results for total score estimation accuracy showed that there was no difference for age; however, results for mean bias and distribution of error revealed that the older group underestimated while the younger group overestimated. In reference to FR, younger adults outperformed older adults (30 versus 14in.) and most prominent, only the younger group showed a significant relationship between estimation and FR. In addition to gaining insight to the effects of advanced age on the ability to mentally represent action and its association with movement execution, these results although preliminary, may have clinical implications based on the question of whether motor imagery training could improve movement estimations and how that might affect actual reach. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Anaphylaxis to dyes during the perioperative period: reports of 14 clinical cases.

PubMed

Mertes, Paul Michel; Malinovsky, Jean Marc; Mouton-Faivre, Claudie; Bonnet-Boyer, Marie Caroline; Benhaijoub, Abdelhaouad; Lavaud, François; Valfrey, Jocelyne; O'Brien, James; Pirat, Philippe; Lalourcey, Laurent; Demoly, Pascal

2008-08-01

Vital dyes are widely used for lymphatic mapping and sentinel lymph node biopsy in patients with malignant tumors, and reports of anaphylactic reactions are becoming more frequent. Our aims were to describe specific clinical features of hypersensitivity reactions to Patent Blue (Guerbet, Roissy, France), results of the allergy workup, and their consequences for patient management. We report a series of 14 clinical cases of dye-induced anaphylaxis recorded between 2004 and 2006 in 4 member centers of a network of French allergoanesthesia outpatient clinics. Reactions appeared to be relatively severe (6/14 grade III reactions). An average 30 +/- 6-minute delay was observed between dye injection and symptom onset. In 9 (65%) patients reactions were sustained for several hours, requiring prolonged continuous epinephrine infusion and transfer to an intensive care unit. Prick test results were positive in 8 patients. In 5 patients prick test results were negative, whereas intradermal test results were positive. Anesthesiologists and allergologists must be aware of this specific risk and of the clinical characteristics of these reactions, which are usually delayed and long lasting.

Interactions between voice clinics and singing teachers: a report on the British Voice Association questionnaire to voice clinics in the UK.

PubMed

Davies, J; Anderson, S; Huchison, L; Stewart, G

2007-01-01

Singers with vocal problems are among patients who present at multidisciplinary voice clinics led by Ear Nose and Throat consultants and laryngologists or speech and language therapists. However, the development and care of the singing voice are also important responsibilities of singing teachers. We report here on the current extent and nature of interactions between voice clinics and singing teachers, based on data from a recent survey undertaken on behalf of the British Voice Association. A questionnaire was sent to all 103 voice clinics at National Health Service (NHS) hospitals in the UK. Responses were received and analysed from 42 currently active clinics. Eight (19%) clinics reported having a singing teacher as an active member of the team. They were all satisfied with the singing teacher's knowledge and expertise, which had been acquired by several different means. Of 32 clinics without a singing teacher regularly associated with the team, funding and difficulty of finding an appropriate singing voice expert (81% and 50%, respectively) were among the main reasons for their absence. There was an expressed requirement for more interaction between voice clinics and singing teachers, and 86% replied that they would find it useful to have a list of singing teachers in their area. On the matter of gaining expertise and training, 74% of the clinics replying would enable singing teachers to observe clinic sessions for experience and 21% were willing to assist in training them for clinic-associated work.

Using the Dreyfus Model of Skill Acquisition to Describe and Interpret Skill Acquisition and Clinical Judgment in Nursing Practice and Education

ERIC Educational Resources Information Center

Benner, Patricia

2004-01-01

Three studies using the Dreyfus model of skill acquisition were conducted over a period of 21 years. Nurses with a range of experience and reported skillfulness were interviewed. Each study used nurses' narrative accounts of actual clinical situations. A subsample of participants were observed and interviewed at work. These studies extend the…

16 CFR 700.4 - Parties “actually making” a written warranty.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Parties âactually makingâ a written warranty... “actually making” a written warranty. Section 110(f) of the Act provides that only the supplier “actually making” a written warranty is liable for purposes of FTC and private enforcement of the Act. A supplier...

Self-perceived health versus actual cardiovascular disease risks.

PubMed

Ko, Young; Boo, Sunjoo

2016-01-01

Self-perceived poor health is related to cardiovascular disease (CVD) risk perception, cardiovascular event, hospital readmission, and death from CVD. This study evaluated the associations between self-perceived health and actual CVD risk in South Koreans as well as the influence of sociodemographic and cardiovascular risk factors on self-perceived poor health. This is a secondary data analysis of the 2010 Korea National Health and Nutrition Examination Survey. The sample was 4535 South Koreans aged 30-74 years without CVD. Self-perceived health status was compared with actual cardiovascular risk separately by sex using χ(2) -tests. Logistic regressions were used to identify potential sociodemographic and cardiovascular risk factors of self-perceived poor health. Self-perceived poor health was related to higher CVD risk but there were substantial gaps between them. Among cardiovascular risk factors, dyslipidemia, obesity, smoking, and a family history of CVD did not affect self-perceived health. Gaps between perceived health and actual CVD risk should be closed to optimize cardiovascular health of South Koreans. Koreans need to increase risk perception to a level commensurate with their actual risk. Healthcare providers should try to provide individuals at increased CVD risk with better information more frequently, especially those who have favorable perceptions of their health but smoke or have elevated cholesterol levels and bodyweight. © 2015 Japan Academy of Nursing Science.

Actual and desired information provision after a stroke.

PubMed

Wachters-Kaufmann, Cresje; Schuling, Jan; The, Hauw; Meyboom-de Jong, Betty

2005-02-01

Stroke patients and caregivers have a substantial information need. The study investigates how information was actually provided to stroke patients and caregivers and how they prefer to be informed. The GP, neurologist and physiotherapist are both the actual and desired information providers. The actual and desired information correspond in terms of content, frequency, and method of presentation. However, patients and caregivers prefer to receive information within 24 h and to be informed about, and be given, relevant written information. The information given by the various professional stroke care-providers could be better co-ordinated. The role of the GP as an information provider lagged quite a long way behind. Recommendations for the provision of an improved information system is given. Most of the subjects are relatively young male patients with few disabilities and healthy caregivers. More attention should be paid to encouraging patients and caregivers to actively seek information to supplement the information given by professional stroke care-providers.

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

PubMed

Jansen, Marleen E; Rigter, T; Rodenburg, W; Fleur, T M C; Houwink, E J F; Weda, M; Cornel, Martina C

2017-01-01

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

Ovarian hyperstimulation syndrome: review and new classification criteria for reporting in clinical trials.

PubMed

Humaidan, P; Nelson, S M; Devroey, P; Coddington, C C; Schwartz, L B; Gordon, K; Frattarelli, J L; Tarlatzis, B C; Fatemi, H M; Lutjen, P; Stegmann, B J

2016-09-01

What is an objective approach that employs measurable and reproducible physiologic changes as the basis for the classification of ovarian hyperstimulation syndrome (OHSS) in order to facilitate more accurate reporting of incidence rates within and across clinical trials? The OHSS flow diagram is an objective approach that will facilitate consistent capture, classification and reporting of OHSS within and across clinical trials. OHSS is a potentially life-threatening iatrogenic complication of the early luteal phase and/or early pregnancy after ovulation induction (OI) or ovarian stimulation (OS). The clinical picture of OHSS (the constellation of symptoms associated with each stage of the disease) is highly variable, hampering its appropriate classification in clinical trials. Although some degree of ovarian hyperstimulation is normal after stimulation, the point at which symptoms transition from those anticipated to those of a disease state is nebulous. An OHSS working group, comprised of subject matter experts and clinical researchers who have significantly contributed to the field of fertility, was convened in April and November 2014. The OHSS working group was tasked with reaching a consensus on the definition and the classification of OHSS for reporting in clinical trials. The group engaged in targeted discussion regarding the scientific background of OHSS, the criteria proposed for the definition and the rationale for universal adoption. An agreement was reached after discussion with all members. One of the following conditions must be met prior to making the diagnosis of OHSS in the context of a clinical trial: (i) the subject has undergone OS (either controlled OS or OI) AND has received a trigger shot for final oocyte maturation (e.g. hCG, GnRH agonist [GnRHa] or kisspeptin) followed by either fresh transfer or segmentation (cryopreservation of embryos) or (ii) the subject has undergone OS or OI AND has a positive pregnancy test. All study patients who

Gastric lymphoma: the histology report.

PubMed

Doglioni, Claudio; Ponzoni, Maurilio; Ferreri, Andrés J M; Savio, Antonella

2011-03-01

The diagnosis of gastric MALT lymphoma is frequently difficult for the general histopathologist. During recent years there have been relevant changes in the therapeutic approach to gastric MALT lymphoma and our knowledge about its pathogenesis has greatly improved. The management of this disease actually requires a close cooperation between the histopathologist and the clinicians. The histology report of biopsies of a newly diagnosed or of an already treated case implies information of clinical and therapeutical relevance. This paper aims at giving the histopathologist a general knowledge about the state of art of this disease and its management. The diagnostic process leading to a complete and competent report is then described step by step. Copyright © 2011 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd.. All rights reserved.

Developments in clinical trials: a Pharma Matters report.

PubMed

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.

Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting.

PubMed

Baker, Meghan A; Kaelber, David C; Bar-Shain, David S; Moro, Pedro L; Zambarano, Bob; Mazza, Megan; Garcia, Crystal; Henry, Adam; Platt, Richard; Klompas, Michael

2015-09-15

Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values, and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the MetroHealth System, an integrated healthcare system in Ohio. We queried the VAERS database to determine MetroHealth's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2%) messages, responded to 209 (15.1%), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95% confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society

78 FR 7437 - Proposed Collection; Comment Request (60-Day FRN); The Clinical Trials Reporting Program (CTRP...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request (60-Day FRN); The Clinical Trials Reporting Program (CTRP) Database (NCI) SUMMARY: In compliance... publication. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925-0600, Expiration...

Experimental philosophy of actual and counterfactual free will intuitions.

PubMed

Feltz, Adam

2015-11-01

Five experiments suggested that everyday free will and moral responsibility judgments about some hypothetical thought examples differed from free will and moral responsibility judgments about the actual world. Experiment 1 (N=106) showed that free will intuitions about the actual world measured by the FAD-Plus poorly predicted free will intuitions about a hypothetical person performing a determined action (r=.13). Experiments 2-5 replicated this result and found the relations between actual free will judgments and free will judgments about hypothetical determined or fated actions (rs=.22-.35) were much smaller than the differences between them (ηp(2)=.2-.55). These results put some pressure on theoretical accounts of everyday intuitions about freedom and moral responsibility. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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.

Clinical application of microencapsulated islets: actual prospectives on progress and challenges.

PubMed

Calafiore, Riccardo; Basta, Giuseppe

2014-04-01

After 25 years of intense pre-clinical work on microencapsulated intraperitoneal islet grafts into non-immunosuppressed diabetic recipients, the application of this procedure to patients with type 1 diabetes mellitus has been a significant step forward. This result, achieved in a few centers worldwide, underlies the safety of biopolymers used for microencapsulation. Without this advance, no permission for human application of microcapsules would have ever been obtained after years of purification technologies applied to the raw alginates. To improve safety of the encapsulated islet graft system, renewed efforts on the capsules' bioengineering, as well as on insulin-producing cells within the capsular membranes, are in progress. It is hoped that advances in these two critical aspects of the cell encapsulation technology will result in wider human application of this system. Copyright © 2013 Elsevier B.V. All rights reserved.

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

PubMed

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

2015-03-01

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

Humanistic Education and Self-Actualization Theory.

ERIC Educational Resources Information Center

Farmer, Rod

1984-01-01

Stresses the need for theoretical justification for the development of humanistic education programs in today's schools. Explores Abraham Maslow's hierarchy of needs and theory of self-actualization. Argues that Maslow's theory may be the best available for educators concerned with educating the whole child. (JHZ)

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers.

PubMed

Chen, Ruijun; Desai, Nihar R; Ross, Joseph S; Zhang, Weiwei; Chau, Katherine H; Wayda, Brian; Murugiah, Karthik; Lu, Daniel Y; Mittal, Amit; Krumholz, Harlan M

2016-02-17

To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States. Cross sectional analysis. Academic medical centers in the United States. Academic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov. Using the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials.gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center. The proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion. We identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177). Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

Quantitative Metrics in Clinical Radiology Reporting: A Snapshot Perspective from a Single Mixed Academic-Community Practice

PubMed Central

Abramson, Richard G.; Su, Pei-Fang; Shyr, Yu

2012-01-01

Quantitative imaging has emerged as a leading priority on the imaging research agenda, yet clinical radiology has traditionally maintained a skeptical attitude toward numerical measurement in diagnostic interpretation. To gauge the extent to which quantitative reporting has been incorporated into routine clinical radiology practice, and to offer preliminary baseline data against which the evolution of quantitative imaging can be measured, we obtained all clinical computed tomography (CT) and magnetic resonance imaging (MRI) reports from two randomly selected weekdays in 2011 at a single mixed academic-community practice and evaluated those reports for the presence of quantitative descriptors. We found that 44% of all reports contained at least one “quantitative metric” (QM), defined as any numerical descriptor of a physical property other than quantity, but only 2% of reports contained an “advanced quantitative metric” (AQM), defined as a numerical parameter reporting on lesion function or composition, excluding simple size and distance measurements. Possible reasons for the slow translation of AQMs into routine clinical radiology reporting include perceptions that the primary clinical question may be qualitative in nature or that a qualitative answer may be sufficient; concern that quantitative approaches may obscure important qualitative information, may not be adequately validated, or may not allow sufficient expression of uncertainty; the feeling that “gestalt” interpretation may be superior to quantitative paradigms; and practical workflow limitations. We suggest that quantitative imaging techniques will evolve primarily as dedicated instruments for answering specific clinical questions requiring precise and standardized interpretation. Validation in real-world settings, ease of use, and reimbursement economics will all play a role in determining the rate of translation of AQMs into broad practice. PMID:22795791

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-29

...; Comment Request Clinical Trials Reporting Program (CTRP) Database (NCI) Summary: Under the provisions of... Collection: Title: Clinical Trials Reporting Program (CTRP) Database. Type of Information Collection Request... Program (CTRP) Database, to serve as a single, definitive source of information about all NCI-supported...

AAPM Task Group 103 report on peer review in clinical radiation oncology physics

PubMed Central

Halvorsen, Per H.; Das, Indra J.; Fraser, Martin; Freedman, D. Jay; Rice, Robert E.; Ibbott, Geoffrey S.; Parsai, E. Ishmael; Robin, T. Tydings; Thomadsen, Bruce R.

2005-01-01

This report provides guidelines for a peer review process between two clinical radiation oncology physicists. While the Task Group's work was primarily focused on ensuring timely and productive independent reviews for physicists in solo practice, these guidelines may also be appropriate for physicists in a group setting, particularly when dispersed over multiple separate clinic locations. To ensure that such reviews enable a collegial exchange of professional ideas and productive critique of the entire clinical physics program, the reviews should not be used as an employee evaluation instrument by the employer. Such use is neither intended nor supported by this Task Group. Detailed guidelines are presented on the minimum content of such reviews, as well as a recommended format for reporting the findings of a review. In consideration of the full schedules faced by most clinical physicists, the process outlined herein was designed to be completed in one working day. PACS numbers: 87.53.Xd, 87.90.+y PMID:16421500

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

PubMed

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.

Bias in reporting of randomised clinical trials in oncology.

PubMed

Vera-Badillo, Francisco E; Napoleone, Marc; Krzyzanowska, Monika K; Alibhai, Shabbir M H; Chan, An-Wen; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Amir, Eitan; Tannock, Ian F

2016-07-01

Bias in reporting efficacy and toxicity in clinical trials may impact treatment decisions. Here, we report quality of reporting of efficacy and of toxicity in articles describing randomised controlled trials (RCTs) of cancer therapy and the association between biased reporting and study results, funding and financial relationships of the authors with the sponsor. We reviewed articles published from July 2010 to December 2012 in six high-impact journals reporting RCTs of systemic treatment for cancer. Bias in reporting of the primary end-point and toxicity were assessed. Associations between biased reporting and study results, funding source and financial ties of the author with the funding source were evaluated using logistic regression. Two hundred articles were identified. Among 107 RCTs where there was no statistically significant difference in the primary end-point between the two arms, 50 (47%) reports used biased reporting in the abstract of the paper to imply benefit of the experimental treatment. Toxicity was not reported in the abstract in 18.5% of the studies and this was associated with a positive primary end-point. Source of funding and financial ties were not associated with biased reporting. Bias in reporting of efficacy outcomes is common for studies with a negative primary end-point and can lead to off-label misuse of experimental therapies, if they are approved for other indications. Toxicity is under-reported, especially for studies with a positive primary end-point, leading to a biased view of the safety of new treatments. Copyright © 2016 Elsevier Ltd. All rights reserved.

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials

PubMed Central

Martin, Staci; Merker, Vanessa L.; Gardner, Kathy L.; Hingtgen, Cynthia M.; Tonsgard, James H.; Schorry, Elizabeth K.; Baldwin, Andrea

2013-01-01

Objectives: Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. Methods: The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Results: Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥8 years. Conclusions: The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials. PMID:24249806

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials.

PubMed

Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Gardner, Kathy L; Hingtgen, Cynthia M; Tonsgard, James H; Schorry, Elizabeth K; Baldwin, Andrea

2013-11-19

Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥ 8 years. The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials.

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

PubMed Central

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

2007-01-01

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. PMID:18021449

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

PubMed

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.

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

PubMed

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

Clinical instructors' and athletic training students' perceptions of teachable moments in an athletic training clinical education setting.

PubMed

Rich, Valerie J

2009-01-01

For some time, educators have advised clinical instructors (CIs) to capture the elusive teachable moment in clinical education. However, a universal definition of a teachable moment does not exist. Without a clear understanding of this concept, CIs and athletic training students (ATSs) may have difficulty facilitating the teachable moment. To recognize and define a teachable moment as it relates to the athletic training clinical education setting and to identify potential barriers to creating the teachable moment. Mixed-methods design employing grounded theory and quantitative analysis. Collegiate sports medicine clinic affiliated with a Commission on Accreditation of Allied Health Education Programs-accredited athletic training education program. 11 CIs (6 men, 5 women) and 11 ATSs (3 men, 8 women). Participants completed a teachable moment questionnaire to define and identify teachable moments. Follow-up semistructured interviews were conducted after data collection. A qualitative analysis was conducted on responses using open, axial, and selective coding. Member checking was conducted to establish trustworthiness. Qualitative data were quantified to descriptively report the findings. Engaged clinical experiences were the overarching theme. Three major themes that defined a teachable moment emerged: (1) professional discourse about skills, techniques, research, and special cases; (2) authentic experience or actual hands-on experience; and (3) skill development or time for skill instruction, practice, role playing, and simulations. Participants reported 158 teachable moments (CIs = 75, ATSs = 83). Lack of time and other duties were examples of barriers hindering the teachable moment. The teachable moment occurs when a CI and an ATS actively participate and interact with each other to enhance learning and foster intellectual curiosity in the clinical education environment. An underlying barrier to the teachable moment is perceived to be the CI's day

Myth Busted: Civilian GPS Receivers Actually do have Access to the L2 Frequency

DTIC Science & Technology

2010-01-01

2011 2. REPORT TYPE 3. DATES COVERED 00-00-2011 to 00-00-2011 4. TITLE AND SUBTITLE Myth Busted: Civilian GPS Receivers Actually do Have Access...matter experts on Position, Navigation and Timing and on the Global Positioning System ( GPS ) constellation. In the course of educat- ing FA40s in...the Space Operations Officer Qualification Course, in less than three months, students receive as many as six briefs dealing with GPS . These briefs

NASPGHAN Clinical Report on Postoperative Recurrence in Pediatric Crohn Disease.

PubMed

Splawski, Judy B; Pffefferkorn, Marian D; Schaefer, Marc E; Day, Andrew S; Soldes, Oliver S; Ponsky, Todd A; Stein, Philip; Kaplan, Jess L; Saeed, Shehzad A

2017-10-01

Pediatric Crohn disease is characterized by clinical and endoscopic relapses. The inflammatory process is considered to be progressive and may lead to strictures, fistulas, and penetrating disease that may require surgery. In addition, medically refractory disease may be treated by surgical resection of inflamed bowel in an effort to reverse growth failure. The need for surgery in childhood suggests severe disease and these patients have an increased risk for recurrent disease and potentially more surgery. Data show that up to 55% of patients had clinical recurrence in the first 2 years after initial surgery. The current clinical report on postoperative recurrence in pediatric Crohn disease reviews the risk factors for early surgery and postoperative recurrence, operative risk factors for recurrence, and prevention and monitoring strategies for postoperative recurrence. We also propose an algorithm for postoperative management in pediatric Crohn disease.

Culture Studies and Self-Actualization Theory.

ERIC Educational Resources Information Center

Farmer, Rod

1983-01-01

True citizenship education is impossible unless students develop the habit of intelligently evaluating cultures. Abraham Maslow's theory of self-actualization, a theory of innate human needs and of human motivation, is a nonethnocentric tool which can be used by teachers and students to help them understand other cultures. (SR)

45 CFR 60.11 - Reporting adverse actions on clinical privileges.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (5 U.S.C. 552a note), (v) Date of birth, (vi) Name of each professional school attended and year of... 45 Public Welfare 1 2012-10-01 2012-10-01 false Reporting adverse actions on clinical privileges. 60.11 Section 60.11 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

45 CFR 60.11 - Reporting adverse actions on clinical privileges.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (5 U.S.C. 552a note), (v) Date of birth, (vi) Name of each professional school attended and year of... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting adverse actions on clinical privileges. 60.11 Section 60.11 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

45 CFR 60.11 - Reporting adverse actions on clinical privileges.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (5 U.S.C. 552a note), (v) Date of birth, (vi) Name of each professional school attended and year of... 45 Public Welfare 1 2011-10-01 2011-10-01 false Reporting adverse actions on clinical privileges. 60.11 Section 60.11 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

In Support of Clinical Case Reports: A System of Causality Assessment

PubMed Central

Hamre, Harald J.; Kienle, Gunver S.

2013-01-01

The usefulness of clinical research depends on an assessment of causality. This assessment determines what constitutes clinical evidence. Case reports are an example of evidence that is frequently overlooked because it is believed they cannot address causal links between treatment and outcomes. This may be a mistake. Clarity on the topic of causality and its assessment will be of benefit for researchers and clinicians. This article outlines an overall system of causality and causality assessment. The system proposed involves two dimensions: horizontal and vertical; each of these dimensions consists of three different types of causality and three corresponding types of causality assessment. Included in this system are diverse forms of case causality illustrated with examples from everyday life and clinical medicine. Assessing case causality can complement conventional clinical research in an era of personalized medicine. PMID:24416665

Clinical compliance of viewing conditions in radiology reporting environments against current guidelines and standards

NASA Astrophysics Data System (ADS)

Daly, S.; Rainford, L.; Butler, M. L.

2014-03-01

Several studies have demonstrated the importance of environmental conditions in the radiology reporting environment, with many indicating that incorrect parameters could lead to error and misinterpretation. Literature is available with recommendations as to the levels that should be achieved in clinical practice, but evidence of adherence to these guidelines in radiology reporting environments is absent. This study audited the reporting environments of four teleradiologist and eight hospital based radiology reporting areas. This audit aimed to quantify adherence to guidelines and identify differences in the locations with respect to layout and design, monitor distance and angle as well as the ambient factors of the reporting environments. In line with international recommendations, an audit tool was designed to enquire in relation to the layout and design of reporting environments, monitor angle and distances used by radiologists when reporting, as well as the ambient factors such as noise, light and temperature. The review of conditions were carried out by the same independent auditor for consistency. The results obtained were compared against international standards and current research. Each radiology environment was given an overall compliance score to establish whether or not their environments were in line with recommended guidelines. Poor compliance to international recommendations and standards among radiology reporting environments was identified. Teleradiology reporting environments demonstrated greater compliance than hospital environments. The findings of this study identified a need for greater awareness of environmental and perceptual issues in the clinical setting. Further work involving a larger number of clinical centres is recommended.

Non-specific physical symptoms in relation to actual and perceived proximity to mobile phone base stations and powerlines

PubMed Central

2011-01-01

Background Evidence about a possible causal relationship between non-specific physical symptoms (NSPS) and exposure to electromagnetic fields (EMF) emitted by sources such as mobile phone base stations (BS) and powerlines is insufficient. So far little epidemiological research has been published on the contribution of psychological components to the occurrence of EMF-related NSPS. The prior objective of the current study is to explore the relative importance of actual and perceived proximity to base stations and psychological components as determinants of NSPS, adjusting for demographic, residency and area characteristics. Methods Analysis was performed on data obtained in a cross-sectional study on environment and health in 2006 in the Netherlands. In the current study, 3611 adult respondents (response rate: 37%) in twenty-two Dutch residential areas completed a questionnaire. Self-reported instruments included a symptom checklist and assessment of environmental and psychological characteristics. The computation of the distance between household addresses and location of base stations and powerlines was based on geo-coding. Multilevel regression models were used to test the hypotheses regarding the determinants related to the occurrence of NSPS. Results After adjustment for demographic and residential characteristics, analyses yielded a number of statistically significant associations: Increased report of NSPS was predominantly predicted by higher levels of self-reported environmental sensitivity; perceived proximity to base stations and powerlines, lower perceived control and increased avoidance (coping) behavior were also associated with NSPS. A trend towards a moderator effect of perceived environmental sensitivity on the relation between perceived proximity to BS and NSPS was verified (p = 0.055). There was no significant association between symptom occurrence and actual distance to BS or powerlines. Conclusions Perceived proximity to BS, psychological

School Guidance Counselors' Perceptions of Actual and Preferred Job Duties

ERIC Educational Resources Information Center

Edwards, John Dexter

2010-01-01

The purpose of this study was to provide process data for school counselors, administrators, and the public, regarding school counselors' actual roles within the guidance counselor preferred job duties and actual job duties. In addition, factors including National Certification or no National Certification, years of counseling experience, and…

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

PubMed

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 <15%. Advantages in using patient-reported outcome 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

Methodological reporting of randomized clinical trials in respiratory research in 2010.

PubMed

Lu, Yi; Yao, Qiuju; Gu, Jie; Shen, Ce

2013-09-01

Although randomized controlled trials (RCTs) are considered the highest level of evidence, they are also subject to bias, due to a lack of adequately reported randomization, and therefore the reporting should be as explicit as possible for readers to determine the significance of the contents. We evaluated the methodological quality of RCTs in respiratory research in high ranking clinical journals, published in 2010. We assessed the methodological quality, including generation of the allocation sequence, allocation concealment, double-blinding, sample-size calculation, intention-to-treat analysis, flow diagrams, number of medical centers involved, diseases, funding sources, types of interventions, trial registration, number of times the papers have been cited, journal impact factor, journal type, and journal endorsement of the CONSORT (Consolidated Standards of Reporting Trials) rules, in RCTs published in 12 top ranking clinical respiratory journals and 5 top ranking general medical journals. We included 176 trials, of which 93 (53%) reported adequate generation of the allocation sequence, 66 (38%) reported adequate allocation concealment, 79 (45%) were double-blind, 123 (70%) reported adequate sample-size calculation, 88 (50%) reported intention-to-treat analysis, and 122 (69%) included a flow diagram. Multivariate logistic regression analysis revealed that journal impact factor ≥ 5 was the only variable that significantly influenced adequate allocation sequence generation. Trial registration and journal impact factor ≥ 5 significantly influenced adequate allocation concealment. Medical interventions, trial registration, and journal endorsement of the CONSORT statement influenced adequate double-blinding. Publication in one of the general medical journal influenced adequate sample-size calculation. The methodological quality of RCTs in respiratory research needs improvement. Stricter enforcement of the CONSORT statement should enhance the quality of RCTs.

[A nationwide investigation needs for rehabilitation of schizophrenic outpatients--the patients' attribute and actual conditions of living].

PubMed

Yamashita, T; Kuroda, K; Hirano, W; Ueno, M; Yoshizumi, A; Inomata, Y; Komine, K

1996-01-01

In Japan we are very short of community resources for persons with mental disability. The authors, a board of resettlement, thought patients' actual conditions of living and needs for rehabilitation to let them live in the community had to be evaluated. Then in March 1993 the actual conditions of living and needs for rehabilitation of schizophrenic outpatients were investigated nationally. This article is the report on the patients' actual conditions of living. Investigation papers were sent to 358 institutions (286 hospitals and 72 clinics) which agreed to cooperate with the investigation. The 5186 investigation papers were received from 313 institutions. All of the papers except 18, which were lack of their ages, were analyzed. All of the schizophrenic outpatients, who consulted psychiatrists on one day during investigation, were considered objects of this research. Those who consented were included the research and psychiatrists filled in investigation papers. These institutions had a policy of intensive social resettlement activities and so on. Male patients were 55% and females were 45%. There were patients in the forties and females were older than males. Thirty-nine percent of them had been hospitalized once or twice. Thirty-four percent of them had been hospitalized for less than one year. Eighteen percent of them had not been hospitalized. Fifty percent of patients answered there was no friend and acquaintance, and had a tendency to stand alone. Fifty-three percent of patients lived with their parents, 21% with their spouses, and 17% alone. But 32% of females lived with their husbands. Sixteen percent worked for full-time jobs, 8% worked part-time jobs, 12% attended day care center 4% went to sheltered-workshops and only 1% went to rehabilitation-workshops for outpatients. While 13% didn't have a right to receive disability pension, the sources of income were job (30%), disability pension (30%), and welfare benefits (12%). Regarding the ability for living

Poor reporting of scientific leadership information in clinical trial registers.

PubMed

Sekeres, Melanie; Gold, Jennifer L; Chan, An-Wen; Lexchin, Joel; Moher, David; Van Laethem, Marleen L P; Maskalyk, James; Ferris, Lorraine; Taback, Nathan; Rochon, Paula A

2008-02-20

In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial

Incident reporting in dentistry: Clinical supervisor's awareness, practice and perceived barriers.

PubMed

AlBlaihed, R M; AlSaeed, M I; Abuabat, A A; Ahsan, S H

2017-12-21

The significance of patient safety and risk management in dentistry has surfaced as dental settings bear delicate procedures carried out by teams utilising numerous devices and tools in complex environments. Our aim is to assess awareness, practice, attitude and perceived barriers of reporting incidents amongst dental clinical supervisors working at dental colleges in Riyadh, Saudi Arabia. The objectives are as follows: (i) Determine if correlations exist between socio-demographic data and supervisors' awareness, practice, attitude and perceived barriers. (ii) Identify most common perceived barriers. An online questionnaire was sent to the 450 clinical supervisors working at five dental colleges of Riyadh. The collected data included items assessing the awareness, practice and attitude of reporting students' incidents along with the perceived barriers. A response rate of (60.1% n = 264 of 450) was established. The majority of the respondents (62.9% n = 166) were aware of the incident reporting policy. Yet, only (35.4% n = 93) of them had completed an incident reporting form before. Most of the participants (90.5% n = 239) agreed on the necessity of reporting student's incidents, but only (67.0% n = 177) agreed on the necessity of reporting well-handled incidents. The possible negative relationship with students was the most agreed on barrier to reporting. This study shows that certain demographics of supervisors had significant relationship with their awareness, attitude, perceived barriers and practice. Awareness of the policy and form was linked to the increase in supervisors' practice, although they tend to report verbally rather than in writing. The possible negative relationship with students was the most common perceived barrier. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Considerations in reporting palliative care clinical trials: Standardizing information reported and authorship practices

PubMed Central

LeBlanc, Thomas W.; Abernethy, Amy P.; Currow, David C.; Kutner, Jean S.

2014-01-01

Purpose of Review The nature of palliative care practice, especially the reliance on referrals and differing models of service delivery, poses unique challenges for the creation and interpretation of an evidence base, frequently limiting the applicability of data to patient care. Here we discuss two core aspects of clinical trials reporting in palliative medicine: 1) proposed standards governing the collection and reporting of data, and 2) rules governing authorship and publication. Recent Findings Existing literature often inadequately describes the characteristics of patients, caregivers, clinicians, systems, and interventions included in studies, thereby limiting the utility of results. Summary A generalizability framework is needed to ensure a robust evidence base that advances practice. Lessons learned through the development of research cooperative groups in palliative care reinforce the importance of an authorship protocol for large trials and working groups. PMID:23080306

Reaching the limits of mandated self-reporting: clinical logbooks do not predict clerkship performance.

PubMed

Huang, Grace C; Almeida, Jacqueline M; Roberts, David H

2012-01-01

Logbooks are used by US medical schools to evaluate curricular objectives and meet accreditation requirements, but research supporting their utility is conflicting. The goal of our study was to examine the relationship between volume of clinical rotation experiences as reported in a logbook and clerkship grades within a longitudinal integrated clerkship. We conducted a retrospective cohort study of third-year (clinical) medical students during academic year 2008-2009. We tracked student entries in a pocket-sized logbook (number of clinical encounters per clerkship, total number of exams, and procedures over the academic year). We performed correlation analyses between logbook entries and clerkship grades. We enrolled 36 students, who reported a total of 2992 encounters, 2262 exams, and 2342 procedures. Correlation coefficients between volume of clinical experience and clerkship grades were less than 0.4, indicating low correlation. We found borderline statistical significance for the Neurology, OB/Gyn, and Surgery clerkships. Sensitivity analyses showed little correlation between low-reporting activity and clerkship grades. Even within an integrated longitudinal clerkship framework, our findings are consistent with previous studies showing a negligible relationship between logbooks as an educational process measure and how they relate to educational outcomes.

Self-Actualization in a Marathon Growth Group: Do the Strong Get Stronger?

ERIC Educational Resources Information Center

Kimball, Ronald; Gelso, Charles J.

This study examined the effects of a weekend marathon on the level of self-actualization of college students one and four weeks following their group experience. It also studied the relationship between ego strength and extent of change in self-actualization during a marathon. Generally, the group experience did increase self-actualization and the…

Temporal characteristics of imagined and actual walking in frail older adults.

PubMed

Nakano, Hideki; Murata, Shin; Shiraiwa, Kayoko; Iwase, Hiroaki; Kodama, Takayuki

2018-05-09

Mental chronometry, commonly used to evaluate motor imagery ability, measures the imagined time required for movements. Previous studies investigating mental chronometry of walking have investigated healthy older adults. However, mental chronometry in frail older adults has not yet been clarified. To investigate temporal characteristics of imagined and actual walking in frail older adults. We investigated the time required for imagined and actual walking along three walkways of different widths [width(s): 50, 25, 15 cm × length: 5 m] in 29 frail older adults and 20 young adults. Imagined walking was measured with mental chronometry. We observed significantly longer imagined and actual walking times along walkways of 50, 25, and 15 cm width in frail older adults compared with young adults. Moreover, temporal differences (absolute error) between imagined and actual walking were significantly greater in frail older adults than in young adults along walkways with a width of 25 and 15 cm. Furthermore, we observed significant differences in temporal differences (constant error) between frail older adults and young adults for walkways with a width of 25 and 15 cm. Frail older adults tended to underestimate actual walking time in imagined walking trials. Our results suggest that walkways of different widths may be a useful tool to evaluate age-related changes in imagined and actual walking in frail older adults.

The use of an intraoral electrolarynx for an edentulous patient: a clinical report.

PubMed

Wee, Alvin G; Wee, Lisa A; Cheng, Ansgar C; Cwynar, Roger B

2004-06-01

This clinical report describes the clinical requirements, treatment sequence, and use of a relatively new intraoral electrolarynx for a completely edentulous patient. This device consists of a sound source attached to the maxilla and a hand-held controller unit that controls the pitch and volume of the intraoral sound source via transmitted radio waves.

Body height preferences and actual dimorphism in stature between partners in two non-Western societies (Hadza and Tsimane').

PubMed

Sorokowski, Piotr; Sorokowska, Agnieszka; Butovskaya, Marina; Stulp, Gert; Huanca, Tomas; Fink, Bernhard

2015-06-16

Body height influences human mate preferences and choice. A typical finding in Western societies is that women prefer men who are taller than themselves and, equivalently, men prefer women who are shorter than themselves. However, recent reports in non-Western societies (e.g., the Himba in Namibia) challenge the view on the universality of such preferences. Here we report on male and female height preferences in two non-Western populations--the Hadza (Tanzania) and the Tsimane' (Bolivia)--and the relationships between body height preferences and the height of actual partners. In the Hadza, most individuals preferred a sexual dimorphism in stature (SDS) with the man being much taller than the woman. Preferences for SDS and actual partner SDS were positively and significantly correlated in both men and women, suggesting that people who preferred larger height differences also had larger height differences with their partners. In the Tsimane', the majority of men preferred an SDS with the man being taller than the woman, but women did not show such a preference. Unlike in the Hadza, SDS preference was not significantly correlated to actual partner SDS. We conclude that patterns of height preferences and choices in the Hadza and Tsimane' are different than those observed in Western societies, and discuss possible causes for the observed differences between non-Western and Western societies.

First report of wild boar susceptibility to Porcine circovirus type 3: High prevalence in the Colli Euganei Regional Park (Italy) in the absence of clinical signs.

PubMed

Franzo, Giovanni; Tucciarone, Claudia Maria; Drigo, Michele; Cecchinato, Mattia; Martini, Marco; Mondin, Alessandra; Menandro, Maria Luisa

2018-05-18

The genus Circovirus includes one of the most relevant infectious agents affecting domestic pigs, Porcine circovirus type 2 (PCV-2). The wild boar susceptibility to this pathogen has also been demonstrated although the actual epidemiological role of wild populations is still debated. In recent times, a new circovirus, Porcine circovirus type 3 (PCV-3), has been discovered and reported in the presence of several clinical conditions. However, no information is currently available about PCV-3 circulation and prevalence in wild boar. To fill this gap, 187 wild boar serum samples were collected in the Colli Euganei Regional Park (Northern Italy) and screened for PCV-3, demonstrating a high viral prevalence (approximately 30%). No gender differences were demonstrated while a lower infection prevalence was observed in animals younger than 12 months compared to older ones, differently from what described in commercial pigs. Almost all sampled animals were in good health conditions and no association was proven between PCV-3 status and clinical syndromes in wild animals. The genetic characterization of selected strains enlightened a relevant variability and the absence of closely related strains originating from domestic pigs. Therefore, the observed scenario is suggestive of multiple introductions from other wild or domestic swine populations followed by prolonged circulation and independent evolution. Worldwide, this study reports for the first time the high susceptibility of the wild boar to PCV-3 infection. The high prevalence and the absence of association with clinical signs support the marginal role of this virus in the wild boar population ecology. However, its epidemiological role as reservoir endangering commercial swine cannot be excluded and will require further investigations. © 2018 Blackwell Verlag GmbH.

Actual use of a front-of-pack nutrition logo in the supermarket: consumers' motives in food choice.

PubMed

Vyth, Ellis L; Steenhuis, Ingrid H M; Vlot, Jessica A; Wulp, Anouk; Hogenes, Meefa G; Looije, Danielle H; Brug, Johannes; Seidell, Jacob C

2010-11-01

A front-of-pack nutrition logo on products with relatively favourable product compositions might help consumers to make more healthful choices. Studies investigating actual nutrition label use in point-of-purchase settings are scarce. The present study investigates the use of the 'Choices' nutrition logo in Dutch supermarkets. Adults were asked to complete a validated questionnaire about motivation for food choice and their purchased products were scored for the Choices logo after they had done their shopping. Nine supermarkets in The Netherlands. A total of 404 respondents participated. Of the respondents, 62 % reported familiarity with the logo. The motivations for food choice that were positively associated with actually purchasing products with the logo were attention to 'weight control' and 'product information'. The food choice motive 'hedonism' was negatively associated with purchasing products with the logo. This is the first study to investigate actual use of the Choices logo. In order to stimulate consumers to purchase more products with a favourable product composition, extra attention should be paid to hedonistic aspects such as the tastefulness and the image of healthy products.

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.

PubMed

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.

Self-Perceived and Actual Motor Competence in Young British Children.

PubMed

Duncan, Michael J; Jones, Victoria; O'Brien, Wesley; Barnett, Lisa M; Eyre, Emma L J

2018-04-01

Children's perception of their own motor competence is an important correlate of their actual motor competence. The current study is the first to examine this association in British children and the first to use both product and process measures of actual motor competence. A total of 258 children (139 boys and 119 girls; aged 4 to 7 years, Mean = 5.6, SD = .96) completed measures of self-perceived motor competence using the Pictorial Scale for Perceived Movement Competence in Young Children. Children were classified as "Low," "Medium," or "High" perceived competence based on tertile analysis. Actual motor competence was assessed with the Test of Gross Motor Development-2 (a process measure) and a composite of 10-m sprint run time, standing long jump distance, and 1-kg seated medicine ball throw (collectively, a product measure). Data for process and product measures were analyzed using a 2 (sex) × 3 (high, medium, low perceived competence) analysis of covariance, with body mass index, calculated from height and mass, and age controlled. Boys obtained significantly higher scores than girls for both the process ( p = .044) and product ( p = .001) measures of actual motor competence. Boys had significantly ( p = .04) higher scores for perceived competence compared to girls. Compared to children classified as medium and high self-perceived competence, children classified as low self-perceived competence had lower process ( p = .001) and product scores (i.e., medium, p = .009 and high, p = .0001) of actual motor competence. Age ( p = .0001) and body mass index ( p = .0001) were significantly associated with product motor competence. Strategies to enhance actual motor competence may benefit children's self-perceived motor competence.

Automated branching pattern report generation for laparoscopic surgery assistance

NASA Astrophysics Data System (ADS)

Oda, Masahiro; Matsuzaki, Tetsuro; Hayashi, Yuichiro; Kitasaka, Takayuki; Misawa, Kazunari; Mori, Kensaku

2015-05-01

This paper presents a method for generating branching pattern reports of abdominal blood vessels for laparoscopic gastrectomy. In gastrectomy, it is very important to understand branching structure of abdominal arteries and veins, which feed and drain specific abdominal organs including the stomach, the liver and the pancreas. In the real clinical stage, a surgeon creates a diagnostic report of the patient anatomy. This report summarizes the branching patterns of the blood vessels related to the stomach. The surgeon decides actual operative procedure. This paper shows an automated method to generate a branching pattern report for abdominal blood vessels based on automated anatomical labeling. The report contains 3D rendering showing important blood vessels and descriptions of branching patterns of each vessel. We have applied this method for fifty cases of 3D abdominal CT scans and confirmed the proposed method can automatically generate branching pattern reports of abdominal arteries.

Tweeting celebrity suicides: Users' reaction to prominent suicide deaths on Twitter and subsequent increases in actual suicides.

PubMed

Ueda, Michiko; Mori, Kota; Matsubayashi, Tetsuya; Sawada, Yasuyuki

2017-09-01

A substantial amount of evidence indicates that news coverage of suicide deaths by celebrities is followed by an increase in suicide rates, suggesting a copycat behavior. However, the underlying process by which celebrity status and media coverage leads to increases in subsequent suicides is still unclear. This study collected over 1 million individual messages ("tweets") posted on Twitter that were related to 26 prominent figures in Japan who died by suicide between 2010 and 2014 and investigated whether media reports on suicide deaths that generated a greater level of reactions by the public are likely to be followed by a larger increase in actual suicides. We also compared the number of Twitter posts and the number of media reports in newspaper and on television to understand whether the number of messages on Twitter in response to the deaths corresponds to the amount of coverage in the traditional media. Using daily data from Japan's national death registry between 2010 and 2014, our analysis found an increase in actual suicides only when suicide deaths generated a large reaction from Twitter users. In contrast, no discernible increase in suicide counts was observed when the analysis included suicide deaths to which Twitter users did not show much interest, even when these deaths were covered considerably by the traditional media. This study also found suicides by relatively young entertainers generated a large number of posts on Twitter. This sharply contrasts with the relatively smaller volume of reaction to them generated by traditional forms of media, which focuses more on the deaths of non-entertainers. The results of this study strongly suggest that it is not sufficient to examine only traditional news media when investigating the impact of media reports on actual suicides. Copyright © 2017 Elsevier Ltd. All rights reserved.

Perceived and actual noise levels in critical care units.

PubMed

White, Brittany Lynn; Zomorodi, Meg

2017-02-01

To compare the noise levels perceived by critical care nurses in the Intensive Care Unit (ICU) to actual noise levels in the ICU. Following a pilot study (n=18) and revision of the survey tool, a random sample of nurses were surveyed twice in a 3-day period (n=108). Nurses perception of noise was compared to the actual sound pressure level using descriptive statistics. Nurses perceived the ICUs to be noisier than the actual values. The ICU was louder than the recommended noise level for resotrative sleep. This finding raises the question of how we can assist nurses to reduce what they perceive to be a loud environment. Future work is needed to develop interventions specifically for nurses to raise awareness of noise in the ICU and to provide them with skills to assist in noise reduction. Copyright © 2016 Elsevier Ltd. All rights reserved.

Clinically unrecognized miliary tuberculosis: an autopsy study.

PubMed

Savic, Ivana; Trifunovic-Skodric, Vesna; Mitrovic, Dragan

2016-01-01

Miliary tuberculosis (TB) usually presents with atypical clinical manifestations; thus it is often recognized only at autopsy. Our objectives were to study the frequency of MT diagnosed at autopsy and determine clinical diagnoses that masked TB, as well as causes of death and comorbidities. Retrospective study of all autopsies performed between 2008 and 2014. Institute of Pathology, Belgrade, Serbia. in subjects where autopsy showed the presence of MT that was not recognized clinically, we recorded the clinical diagnoses (presumed causes of death) as reported in autopsy request forms, as well as actual cause of death and comorbidities as determined at autopsy. Clinically unrecognized MT. The total number of autopsies in this period was 6206. thirty-five individuals showed clinically unrecognized MT (0.56% of all autopsies, age: 62.2 [17.2] years, M:F=2:3). Common clinical diagnoses masking pulmonary MT were exacerbation of COPD (25%) and pulmonary thromboembolism (25%), with common radiological presentation of diffuse pulmonary infiltrates (56.3%). Dominant clinical diagnoses in patients with generalized MT were adult respiratory distress syndrome, sepsis, gastrointestinal bleeding and meningoencephalitis. Disseminated MT was often associated with secondary anemia or thrombocytopenia (15.8%) and recent surgery (15.8%). Frequent comorbidities included chronic renal failure and malignancies, whereas MT was a dominant cause of death. Greater awareness of MT is needed to improve recognition in clinical settings. In particular, MT should be considered in patients with atypical clinical presentation and diffuse pulmonary infiltrates on chest X-ray, particularly if they have chronic renal failure, malignancy, hematological disorders or a history of recent surgery. None.

Impact of a voice recognition system on report cycle time and radiologist reading time

NASA Astrophysics Data System (ADS)

Melson, David L.; Brophy, Robert; Blaine, G. James; Jost, R. Gilbert; Brink, Gary S.

1998-07-01

Because of its exciting potential to improve clinical service, as well as reduce costs, a voice recognition system for radiological dictation was recently installed at our institution. This system will be clinically successful if it dramatically reduces radiology report turnaround time without substantially affecting radiologist dictation and editing time. This report summarizes an observer study currently under way in which radiologist reporting times using the traditional transcription system and the voice recognition system are compared. Four radiologists are observed interpreting portable intensive care unit (ICU) chest examinations at a workstation in the chest reading area. Data are recorded with the radiologists using the transcription system and using the voice recognition system. The measurements distinguish between time spent performing clerical tasks and time spent actually dictating the report. Editing time and the number of corrections made are recorded. Additionally, statistics are gathered to assess the voice recognition system's impact on the report cycle time -- the time from report dictation to availability of an edited and finalized report -- and the length of reports.

Financial management of a large multisite randomized clinical trial.

PubMed

Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

2014-08-01

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

Intracranial imaging of uncommon diseases is more frequently reported in clinical publications than in radiology publications.

PubMed

Lehman, V T; Doolittle, D A; Hunt, C H; Eckel, L J; Black, D F; Schwartz, K M; Diehn, F E

2014-01-01

Descriptions of uncommon diseases with intracranial imaging abnormalities are often difficult to find in the radiology literature. We hypothesized that reported imaging findings of such conditions in the recent literature were more frequent in clinical compared with radiology journals. PubMed searches from December 1, 2007 to December 1, 2012 were performed for 5 uncommon CNS diseases with intracranial imaging manifestations: 1) Susac syndrome; 2) amyloid β-related angiitis; 3) Parry-Romberg syndrome/en coup de sabre; 4) transient lesion of the splenium of the corpus callosum; and 5) reversible cerebral vasoconstriction syndrome. Articles were classified as a case report, case series, or original research. Journals were categorized as radiology or clinical. The 1- and 5-year Impact Factors of the journals were recorded. Two hundred two articles were identified for the 5 diseases, including 151 (74%) case reports, 26 case series (13%), and 25 original research articles (13%); 179 (89%) were published in nonradiology journals, compared with 23 (11%) in radiology journals. There was no significant difference between the mean 1- and 5-year Impact Factors of the radiology and clinical journals. Recent reports of the selected uncommon diseases with intracranial manifestations are more frequent in clinical journals when compared with dedicated radiology publications. Most publications are case reports. Radiologists should review both radiology and clinical journals when reviewing imaging features of uncommon diseases affecting the brain. Lack of reporting on such disease in the radiology literature may have significant practice, educational, and research implications for the radiology community.

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

PubMed Central

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

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

PubMed

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

2016-08-05

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.

System Architecture for Temporal Information Extraction, Representation and Reasoning in Clinical Narrative Reports

PubMed Central

Zhou, Li; Friedman, Carol; Parsons, Simon; Hripcsak, George

2005-01-01

Exploring temporal information in narrative Electronic Medical Records (EMRs) is essential and challenging. We propose an architecture for an integrated approach to process temporal information in clinical narrative reports. The goal is to initiate and build a foundation that supports applications which assist healthcare practice and research by including the ability to determine the time of clinical events (e.g., past vs. present). Key components include: (1) a temporal constraint structure for temporal expressions and the development of an associated tagger; (2) a Natural Language Processing (NLP) system for encoding and extracting medical events and associating them with formalized temporal data; (3) a post-processor, with a knowledge-based subsystem to help discover implicit information, that resolves temporal expressions and deals with issues such as granularity and vagueness; and (4) a reasoning mechanism which models clinical reports as Simple Temporal Problems (STPs). PMID:16779164

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

PubMed Central

2016-01-01

Purpose To investigate the relationship between two distinct measures of disability: self-reported functional limitations and objectively-screened clinical impairments. Methods 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. Results 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

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

PubMed

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

Response Bias on Self-Report Measures of Sexual Fantasies Among Sexual Offenders.

PubMed

Seifert, Kindra; Boulas, Jenna; Huss, Matthew T; Scalora, Mario J

2017-02-01

The impact of sexual fantasies in future risk and treatment response among sexual offenders has long been known. However, as we develop objective self-report measures of sexual fantasies, response bias is becoming an increasing concern. In examining a sample of institutionalized sex offenders, the present study suggests that offenders' responses on these measures are prone to response bias, the bias does not negate their associations with other self-report measures of sexual deviance, and relationship of their sexual fantasies does not appear to relate to actual behavioral indications. Clinical and research implications for these findings are discussed.

Financial Management of a Large Multi-site Randomized Clinical Trial

PubMed Central

Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.

2014-01-01

Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748

[The whole world in a cup of coffee. Case reports].

PubMed

De Fiore, Luca

2009-01-01

There is a rising interest for clinical cases in medicine. Actually, they don't necessarily conflict with the evidence-based medicine approach; rather, as several authors made clear, EBM-oriented case reports and clinical trials could be complementary. Cases and case series could even represent the first line of evidence and they are extremely valuable in discovering new pathologies and monitoring unexpected drug effects. They also play a relevant role in continuing medical education. The new section of Recenti Progressi in Medicina is edited by a prominent Italian research Institute (Istituto di Fisiologia Clinica, CNR). It focuses on a single case, guiding the physicians' decision-making from differential diagnosis to the treatment options.

Time Experiences, Self-actualizing Values, and Creativity

ERIC Educational Resources Information Center

Yonge, George D.

1975-01-01

The correlations between the Personal Orientation Inventory and Inventory of Temporal Experiences are investigated. The interpretations of these findings are made in light of the theories which postulate a convergence between time, self actualization and creativity. (Author/DEP)

From preferred to actual mate characteristics: the case of human body shape.

PubMed

Courtiol, Alexandre; Picq, Sandrine; Godelle, Bernard; Raymond, Michel; Ferdy, Jean-Baptiste

2010-09-27

The way individuals pair to produce reproductive units is a major factor determining evolution. This process is complex because it is determined not only by individual mating preferences, but also by numerous other factors such as competition between mates. Consequently, preferred and actual characteristics of mates obtained should differ, but this has rarely been addressed. We simultaneously measured mating preferences for stature, body mass, and body mass index, and recorded corresponding actual partner's characteristics for 116 human couples from France. Results show that preferred and actual partner's characteristics differ for male judges, but not for females. In addition, while the correlation between all preferred and actual partner's characteristics appeared to be weak for female judges, it was strong for males: while men prefer women slimmer than their actual partner, those who prefer the slimmest women also have partners who are slimmer than average. This study therefore suggests that the influences of preferences on pair formation can be sex-specific. It also illustrates that this process can lead to unexpected results on the real influences of mating preferences: traits considered as highly influencing attractiveness do not necessarily have a strong influence on the actual pairing, the reverse being also possible.

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

PubMed

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

2016-02-01

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

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

PubMed

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.

Research and Clinical Center for Child Development Annual Report, 1993-1994, No. 17.

ERIC Educational Resources Information Center

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. Six topics are covered in the report. The articles are: (1) "Development of Intentional Behavior in Early Infancy" (Hongtu Chen); (2) "An Investigation of the Differences of Social Space in the Playroom: Through…

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

ERIC Educational Resources Information Center

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…

When perceptions defy reality: The relationships between depression and actual and perceived Facebook social support.

PubMed

Park, Jiyoung; Lee, David Seungjae; Shablack, Holly; Verduyn, Philippe; Deldin, Patricia; Ybarra, Oscar; Jonides, John; Kross, Ethan

2016-08-01

Although the relationship between depression and "offline" social support is well established, numerous questions surround the relationship between "online" social support and depression. We explored this issue by examining the social support dynamics that characterize the way individuals with varying levels of depression (Study 1) and SCID-diagnosed clinically depressed and non-depressed individuals (Study 2) interact with Facebook, the world's largest online social network. Using a novel methodology, we examined how disclosing positive or negative information on Facebook influences the amount of social support depressed individuals (a) actually receive (based on actual social support transactions recorded on Facebook walls) and (b) think they receive (based on subjective assessments) from their Facebook network. Contrary to prior research indicating that depression correlates with less actual social support from "offline" networks, across both studies depression was positively correlated with social support from Facebook networks when participants disclosed negative information (p=.02 in Study 1 and p=.06 in Study 2). Yet, depression was negatively correlated with how much social support participants thought they received from their Facebook networks (p=.005 in Study 1 and p=.001 in Study 2). The sample size was relatively small in Study 2, reflecting difficulties of recruiting individuals with Major Depressive Disorder. These results demonstrate that an asymmetry characterizes the relationship between depression and different types of Facebook social support and further identify perceptions of Facebook social support as a potential intervention target. (243 words; 250 max). Copyright © 2016 Elsevier B.V. All rights reserved.

Factors Associated with Congruence Between Preferred and Actual Place of Death

PubMed Central

Bell, Christina L.; Somogyi-Zalud, Emese; Masaki, Kamal H.

2009-01-01

Congruence between preferred and actual place of death may be an essential component in terminal care. Most patients prefer a home death, but many patients do not die in their preferred location. Specialized (physician, hospice and palliative) home care visits may increase home deaths, but factors associated with congruence have not been systematically reviewed. This study sought to review the extent of congruence reported in the literature, and examine factors that may influence congruence. In July 2009, a comprehensive literature search was performed using MEDLINE, Psych Info, CINAHL, and Web of Science. Reference lists, related articles, and the past five years of six palliative care journals were also searched. Overall congruence rates (percentage of met preferences for all locations of death) were calculated for each study using reported data to allow cross-study comparison. Eighteen articles described 30% to 91% congruence. Eight specialized home care studies reported 59% to 91% congruence. A physician-led home care program reported 91% congruence. Of the 10 studies without specialized home care for all patients, seven reported 56% to 71% congruence and most reported unique care programs. Of the remaining three studies without specialized home care for all patients, two reported 43% to 46% congruence among hospital inpatients, and one elicited patient preference “if everything were possible,” with 30% congruence. Physician support, hospice enrollment, and family support improved congruence in multiple studies. Research in this important area must consider potential sources of bias, the method of eliciting patient preference, and the absence of a single ideal place of death. PMID:20116205

Tuberculous spondylodiscitis: epidemiology, clinical features, treatment, and outcome.

PubMed

Trecarichi, E M; Di Meco, E; Mazzotta, V; Fantoni, M

2012-04-01

Tuberculous spondylodiscitis (TS) is a rare but serious clinical condition which may lead to severe deformity and early or late neurological complications. To discuss certain aspects of the approach to TSs, focusing upon epidemiology, diagnosis, and treatment outcome. For the purpose of this review, a literature search was performed using the Pubmed database through to 19th October 2011 to identify studies published in the last 20 years, concerned in epidemiological, clinical, diagnostic, and therapeutical aspects of TS in adults. Only studies drafted in English language and reporting case series of more than 20 patients have been included. TS has been reported to accounts for 1-5% of all TB cases, and for about 50% of the cases of articulo-skeletal TB infections. Despite the actual availability of more effective diagnostic tools, early recognition of TS remains difficult and a high index of suspicion is needed due to the chronic nature of the disease and its insidious and variable clinical presentation. A prompt diagnosis is required to improve long term outcome, and a microbiological confirmation is recommended to enable appropriate choice of anti-mycobacterial agents. Surgery has an important role in alleviating pain, correcting deformities and neurological impairment, and restoring function. Further studies are required to assess the appropriate duration of anti-microbial treatment, also in regarding of a combined surgical approach.

Factors influencing the difference between forecasted and actual drug sales volumes under the price-volume agreement in South Korea.

PubMed

Park, Sun-Young; Han, Euna; Kim, Jini; Lee, Eui-Kyung

2016-08-01

This study analyzed factors contributing to increases in the actual sales volumes relative to forecasted volumes of drugs under price-volume agreement (PVA) policy in South Korea. Sales volumes of newly listed drugs on the national formulary are monitored under PVA policy. When actual sales volume exceeds the pre-agreed forecasted volume by 30% or more, the drug is subject to price-reduction. Logistic regression assessed the factors related to whether drugs were the PVA price-reduction drugs. A generalized linear model with gamma distribution and log-link assessed the factors influencing the increase in actual volumes compared to forecasted volume in the PVA price-reduction drugs. Of 186 PVA monitored drugs, 34.9% were price-reduction drugs. Drugs marketed by pharmaceutical companies with previous-occupation in the therapeutic markets were more likely to be PVA price-reduction drugs than drugs marketed by firms with no previous-occupation. Drugs of multinational pharmaceutical companies were more likely to be PVA price-reduction drugs than those of domestic companies. Having more alternative existing drugs was significantly associated with higher odds of being PVA price-reduction drugs. Among the PVA price-reduction drugs, the increasing rate of actual volume compared to forecasted volume was significantly higher in drugs with clinical usefulness. By focusing the negotiation efforts on those target drugs, PVA policy can be administered more efficiently with the improved predictability of the drug sales volumes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Does NDPH exist? Some clinical considerations.

PubMed

Manzoni, G C; Torelli, P

2011-05-01

The analysis of case series of new daily persistent headache (NDPH) reported so far in the literature and the clinical evaluation of affected patients seen at headache clinics suggest that the current International Classification of Headache Disorders (ICHD-II) diagnostic criteria for NDPH are not adequate. In particular, in several instances headache features are not consistent with those of tension-type headache, as the ICHD-II expects. Before making a diagnosis of primary NDPH, it is imperative to rule out that it may be due to any underlying systemic disease. Just as importantly, the presence of psychiatric comorbidity and the possible role played by stressful life factors in triggering NDPH onset should also be searched for. Probably, it will only be through some future improvement in the classification of headache attributed to psychiatric disorder (chapter 12 of the ICHD-II) on the one hand, and through a careful psychological evaluation of patients currently diagnosed as NDPH sufferers on the other, that we will finally know whether primary NDPH actually exists.

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

PubMed

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

2013-09-01

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

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

PubMed

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.

The Wayfinding Questionnaire: A clinically useful self-report instrument to identify navigation complaints in stroke patients.

PubMed

de Rooij, N K; Claessen, M H G; van der Ham, I J M; Post, M W M; Visser-Meily, J M A

2017-07-18

Post-stroke navigation complaints are frequent (about 30%) and intervention is possible, but there is no assessment instrument to identify patients with navigation complaints. We therefore studied the clinical validity of the Wayfinding Questionnaire (WQ) in a cross-sectional study with 158 chronic stroke patients and 131 healthy controls. Patients with low (more navigation complaints) versus normal WQ scores were compared for demographics, stroke characteristics, emotional and cognitive complaints, and health-related quality of life (HRQoL). Actual navigation performance of 78 patients was assessed in a virtual reality setting. Effect sizes (d) were calculated. WQ responses (22 items) of stroke patients were compared with those of controls (discriminant validity). Results showed that patients with a low WQ score (n = 49, 32%) were more often women (p = 0.013) and less educated (p = 0.004), reported more cognitive complaints (d = 0.69), more emotional problems (d = 0.38 and 0.52), and lower HRQoL (d = 0.40 and 0.45) and, last but not least, performed worse on the navigation ability tasks (d = 0.23-0.80). Patients scored lower than controls on 21/22 WQ items, predominantly with small to medium effect sizes (d = 0.20-0.51). We conclude that the WQ is valid as a measure of navigation complaints in stroke patients, and thus strongly advocate its use in stroke care.

Actual and Recalled Test Anxiety and Flexibility, Rigidity, and Self-Control.

ERIC Educational Resources Information Center

DeVito, Anthony J.; Kubis, Joseph F.

1983-01-01

Compared recalled and actual test anxiety in college students (N=71) and examined the interrelationship of anxiety with personality variables and sex differences. Results showed recalled test anxiety to be significantly higher than actual test anxiety and indicated no significant differences according to sex. (LLL)

The Use of Published Clinical Study Reports to Support U.S. Food and Drug Administration Approval of Imaging Agents.

PubMed

Rieves, Dwaine; Jacobs, Paula

2016-12-01

Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical studies to support approval of a new imaging agent by the U.S. Food and Drug Administration (FDA). In uncommon situations, the FDA has approved imaging agents based solely, or in large part, on the clinical study experience described in published reports, including reports of exploratory (i.e., phase 1 or 2) studies performed at a single clinical site. We performed a survey of published reports to assess the potential of the reported information to support FDA approval of a commonly cited investigational imaging agent. Our survey revealed critical data limitations in most publications, all of which reported exploratory clinical studies. Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from publications, FDA guidance, and our experience in reviewing publications. We also present a key-data checklist for investigators to consider in the design, conduct, and reporting of exploratory clinical studies for publication. We encourage editors and peer reviewers to consider requiring these key data when reviewing these reports for publication. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

From Preferred to Actual Mate Characteristics: The Case of Human Body Shape

PubMed Central

Courtiol, Alexandre; Picq, Sandrine; Godelle, Bernard; Raymond, Michel; Ferdy, Jean-Baptiste

2010-01-01

The way individuals pair to produce reproductive units is a major factor determining evolution. This process is complex because it is determined not only by individual mating preferences, but also by numerous other factors such as competition between mates. Consequently, preferred and actual characteristics of mates obtained should differ, but this has rarely been addressed. We simultaneously measured mating preferences for stature, body mass, and body mass index, and recorded corresponding actual partner's characteristics for 116 human couples from France. Results show that preferred and actual partner's characteristics differ for male judges, but not for females. In addition, while the correlation between all preferred and actual partner's characteristics appeared to be weak for female judges, it was strong for males: while men prefer women slimmer than their actual partner, those who prefer the slimmest women also have partners who are slimmer than average. This study therefore suggests that the influences of preferences on pair formation can be sex-specific. It also illustrates that this process can lead to unexpected results on the real influences of mating preferences: traits considered as highly influencing attractiveness do not necessarily have a strong influence on the actual pairing, the reverse being also possible. PMID:20885953

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

PubMed

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.

Response to actual and simulated recordings of conventional takeoff and landing jet aircraft

NASA Technical Reports Server (NTRS)

Mabry, J. E.; Sullivan, B. M.

1978-01-01

Comparability between noise characteristics of synthesized recordings of aircraft in flight and actual recordings were investigated. Although the synthesized recordings were more smoothly time-varying than the actual recordings and the synthesizer could not produce a comb-filter effect that was present in the actual recordings, results supported the conclusion that annoyance response is comparable to the synthesized and actual recordings. A correction for duration markedly improved the validity of engineering calculation procedures designed to measure noise annoyance. Results led to the conclusion that the magnitude estimation psychophysical method was a highly reliable approach for evaluating engineering calculation procedures designed to measure noise annoyance. For repeated presentations of pairs of actual recordings, differences between judgment results for identical signals ranged from 0.0 to 0.5 db.

The actual citation impact of European oncological research.

PubMed

López-Illescas, Carmen; de Moya-Anegón, Félix; Moed, Henk F

2008-01-01

This study provides an overview of the research performance of major European countries in the field Oncology, the most important journals in which they published their research articles, and the most important academic institutions publishing them. The analysis was based on Thomson Scientific's Web of Science (WoS) and calculated bibliometric indicators of publication activity and actual citation impact. Studying the time period 2000-2006, it gives an update of earlier studies, but at the same time it expands their methodologies, using a broader definition of the field, calculating indicators of actual citation impact, and analysing new and policy relevant aspects. Findings suggest that the emergence of Asian countries in the field Oncology has displaced European articles more strongly than articles from the USA; that oncologists who have published their articles in important, more general journals or in journals covering other specialties, rather than in their own specialist journals, have generated a relatively high actual citation impact; and that universities from Germany, and--to a lesser extent--those from Italy, the Netherlands, UK, and Sweden, dominate a ranking of European universities based on number of articles in oncology. The outcomes illustrate that different bibliometric methodologies may lead to different outcomes, and that outcomes should be interpreted with care.

Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

PubMed

Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean

2012-12-01

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.

25 CFR 39.101 - Does ISEF assess the actual cost of school operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Does ISEF assess the actual cost of school operations? 39... SCHOOL EQUALIZATION PROGRAM Indian School Equalization Formula § 39.101 Does ISEF assess the actual cost of school operations? No. ISEF does not attempt to assess the actual cost of school operations either...

Preparing physical therapy students for the role of clinical educator: a case study report.

PubMed

Dockter, Mary; Roller, Joellen; Eckert, Jody

2013-01-01

The purpose of this case report was to describe an innovative model for transforming physical therapist students into clinical instructors with the use of a pro bono clinic. This model may assist other academic programs in creating effective approaches to transition entry-level students into future quality clinical instructors. Third year physical therapist students served as clinical instructors for second year students. Peer and self assessments were collected to assess intended objectives. Second year students were made more aware of the role of the clinical instructor and were able to evaluate the effectiveness of clinical teaching and third year students appreciated the impact of clinical teaching and increased their desire to become clinical instructors in the future. Student self and peer assessments reveal that this experiential model is an effective way of transitioning entry-level physical therapist students into the role of clinical instructor.

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

PubMed

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.

Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) and performance of everyday life tasks: Actual Reality.

PubMed

Goverover, Yael; Chiaravalloti, Nancy; DeLuca, John

2016-04-01

Recently, a brief cognitive assessment (Brief International Cognitive Assessment for Multiple Sclerosis: BICAMS) has been recommended for use with patients diagnosed with multiple sclerosis (MS) to screen for cognitive impairments. However, the relationship between the BICAMS and everyday life activity has not been examined. The aim of this study was to examine whether the BICAMS can predict performance of activities of daily living using Actual Reality(TM) (AR) in persons with MS. A between-subjects design was utilized to compare 41 individuals with MS and 32 healthy controls (HC) performing BICAMS and an AR task. Participants were asked to access the internet to purchase a flight ticket or cookies, and were administered the BICAMS and questionnaires to assess quality of life (QOL), affect symptomatology, and prior internet experience. Participants with MS performed significantly worse than HC on the BICAMS and the AR. Additionally, better BICAMS performance was associated with more independent AR performance. Self-reports of QOL were not correlated with AR or BICAMS performance. Individuals with MS have greater problems with actual everyday life tasks as compared to HC. The BICAMS is a promising cognitive screening tool to predict actual functional performance in participants with MS. © The Author(s), 2015.

25 CFR 39.201 - Does ISEF reflect the actual cost of school operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Does ISEF reflect the actual cost of school operations... Does ISEF reflect the actual cost of school operations? ISEF does not attempt to assess the actual cost of school operations either at the local school level or in the aggregate nationally. ISEF is a...

Actual questions raised by nanoparticle radiosensitization

NASA Astrophysics Data System (ADS)

Brun, Emilie; Sicard-Roselli, Cécile

2016-11-01

Radiosensitization by metallic nanoparticles (NP) has been explored for more than a decade with promising results in vitro and in cellulo reported in a vast number of publications. Yet, few clinical trials are on-going. This could be related to the lack of selectivity of NP leading to massive quantities to be injected to observe an effect but also to the higher degree of complexity than first thought leading to an absence of consensus probably caused by the lack of standardization in pre-clinical studies. Given the wide panel of NP used, in terms of core nature, size, coating, not to mention of cell lines and irradiation modalities, cross-comparison of data is not a walk in the park. But only a thorough examination could help identifying the key parameters and the possible mechanisms involved. This step is crucial as it should provide guidance for designing the most efficient combination NP/radiation and rationally establishing clinical protocols. In this review, we will combine and confront cellular radiosensitization results with in vitro and numerical experiments in order to give the more recent vision of this complex phenomenon. We decided to address a few hot topics such as the influence of the incident radiation energy, the localization of NP or the so-called ;biological; effect. We will highlight that among the barriers to break down, some are not restricted to the ;nano; community: an incontestable support could be offered by the ;radiation; community in the broadest sense.

Willingness to pay for cataract surgery is much lower than actual costs in Zamfara state, northern Nigeria.

PubMed

Ibrahim, Nazaradden; Ramke, Jacqueline; Pozo-Martin, Francisco; Gilbert, Clare E

2018-06-01

Direct medical and non-medical costs incurred by those undergoing subsidised cataract surgery at Gusau eye clinic, Zamfara state, were recently determined. The aim of this study was to assess the willingness to pay for cataract surgery among adults with severe visual impairment or blindness from cataract in rural Zamfara and to compare this to actual costs. In three rural villages served by Gusau eye clinic, key informants helped identify 80 adults with bilateral severe visual impairment or blindness (<6/60), with cataract being the cause in at least one eye. The median amount participants were willing to pay for cataract surgery was determined. The proportion willing to pay actual costs of the (i) subsidised surgical fee (US$18.5), (ii) average non-medical expenses (US$25.2), and (iii) average total expenses (US$51.2) at Gusau eye clinic were calculated. Where participants would seek funds for surgery was determined. Among 80 participants (38% women), most (n = 73, 91%) were willing to pay something, ranging from

Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

PubMed

Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

2017-06-15

Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

Verification of Emmert's law in actual and virtual environments.

PubMed

Nakamizo, Sachio; Imamura, Mariko

2004-11-01

We examined Emmert's law by measuring the perceived size of an afterimage and the perceived distance of the surface on which the afterimage was projected in actual and virtual environments. The actual environment consisted of a corridor with ample cues as to distance and depth. The virtual environment was made from the CAVE of a virtual reality system. The afterimage, disc-shaped and one degree in diameter, was produced by flashing with an electric photoflash. The observers were asked to estimate the perceived distance to surfaces located at various physical distances (1 to 24 m) by the magnitude estimation method and to estimate the perceived size of the afterimage projected on the surfaces by a matching method. The results show that the perceived size of the afterimage was directly proportional to the perceived distance in both environments; thus, Emmert's law holds in virtual as well as actual environments. We suggest that Emmert's law is a specific case of a functional principle of distance scaling by the visual system.

Case Report: Clinically amyopathic dermatomyositis presenting acutely with isolated facial edema

PubMed Central

Pappa, Efthymia; Gkeka, Marina; Protogerou, Asimina; Marinos, Leonidas; Loupa, Chariclia; Christopoulos, Constantinos

2018-01-01

A 45-year-old Asian man presented with acute-onset periorbital and facial edema associated with pyrexia. Muscle weakness was absent. Initial laboratory investigations showed an inflammatory reaction, while screening for infections was negative. Serum muscle enzyme levels were normal. He was hospitalized and treated empirically with antibiotics and corticosteroids, pending the result of facial skin and muscle biopsy. He showed a good clinical and laboratory response but an attempt to discontinue corticosteroids led to a prompt relapse of facial edema and pyrexia, associated with rising laboratory indices of inflammation. Biopsy findings were typical of dermatomyositis. Reintroduction of corticosteroid treatment resulted in complete clinical and laboratory remission. Facial edema as the sole clinical manifestation of dermatomyositis is extremely rare. There have been no previous reports of isolated facial edema in the setting of acute, clinically amyopathic dermatomyositis in adults. A high level of suspicion is required to make the diagnosis in the absence of myopathy and the hallmark cutaneous manifestations of the disease (heliotrope rash, Gottron papules). PMID:29707197

Information on actual medication use and drug-related problems in older patients: questionnaire or interview?

PubMed

Willeboordse, Floor; Grundeken, Lucienne H; van den Eijkel, Lisanne P; Schellevis, François G; Elders, Petra J M; Hugtenburg, Jacqueline G

2016-04-01

Information on medication use and drug-related problems is important in the preparation of clinical medication reviews. Critical information can only be provided by patients themselves, but interviewing patients is time-consuming. Alternatively, patient information could be obtained with a questionnaire. In this study the agreement between patient information on medication use and drug-related problems in older patients obtained with a questionnaire was compared with information obtained during an interview. General practice in The Netherlands. A questionnaire was developed to obtain information on actual medication use and drug-related problems. Two patient groups ≥65 years were selected based on general practitioner electronic medical records in nine practices; I. polypharmacy and II. ≥1 predefined general geriatric problems. Eligible patients were asked to complete the questionnaire and were interviewed afterwards. Agreement on information on medication use and drug-related problems collected with the questionnaire and interview was calculated. Ninety-seven patients participated. Of all medications used, 87.6 % (95 % CI 84.7-90.5) was reported identically in the questionnaire and interview. Agreement for the complete medication list was found for 45.4 % (95 % CI 35.8-55.3) of the patients. On drug-related problem level, agreement between questionnaire and interview was 75 %. Agreement tended to be lower in vulnerable patients characterized by ≥4 chronic diseases, ≥10 medications used and low health literacy. Information from a questionnaire showed reasonable agreement compared with interviewing. The patients reported more medications and drug-related problems in the interview than the questionnaire. Taking the limitations into account, a questionnaire seems a suitable tool for medication reviews that may replace an interview for most patients.

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

PubMed

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.

Responsibility after the apparent end: 'following-up' in clinical ethics consultation.

PubMed

Finder, Stuart G; Bliton, Mark J

2011-09-01

Clinical ethics literature typically presents ethics consultations as having clear beginnings and clear ends. Experience in actual clinical ethics practice, however, reflects a different characterization, particularly when the moral experiences of ethics consultants are included in the discussion. In response, this article emphasizes listening and learning about moral experience as core activities associated with clinical ethics consultation. This focus reveals that responsibility in actual clinical ethics practice is generated within the moral scope of an ethics consultant's activities as she or he encounters the unique and specific features that emerge from interactions with a specific patient, or family, or practitioner within a given situation and over time. A long-form narrative about an ethics consultant's interactions is interwoven with a more didactic discussion to highlight the theme of responsibility and to probe questions that arise regarding follow-up within the practice of clinical ethics consultation. © 2011 Blackwell Publishing Ltd.

The impact of Public Reporting on clinical outcomes: a systematic review and meta-analysis.

PubMed

Campanella, Paolo; Vukovic, Vladimir; Parente, Paolo; Sulejmani, Adela; Ricciardi, Walter; Specchia, Maria Lucia

2016-07-22

To assess both qualitatively and quantitatively the impact of Public Reporting (PR) on clinical outcomes, we carried out a systematic review of published studies on this topic. Pubmed, Web of Science and SCOPUS databases were searched to identify studies published from 1991 to 2014 that investigated the relationship between PR and clinical outcomes. Studies were considered eligible if they investigated the relationship between PR and clinical outcomes and comprehensively described the PR mechanism and the study design adopted. Among the clinical outcomes identified, meta-analysis was performed for overall mortality rate which quantitative data were exhaustively reported in a sufficient number of studies. Two reviewers conducted all data extraction independently and disagreements were resolved through discussion. The same reviewers evaluated also the quality of the studies using a GRADE approach. Twenty-seven studies were included. Mainly, the effect of PR on clinical outcomes was positive. Meta-analysis regarding overall mortality included, in a context of high heterogeneity, 10 studies with a total of 1,840,401 experimental events and 3,670,446 control events and resulted in a RR of 0.85 (95 % CI, 0.79-0.92). The introduction of PR programs at different levels of the healthcare sector is a challenging but rewarding public health strategy. Existing research covering different clinical outcomes supports the idea that PR could, in fact, stimulate providers to improve healthcare quality.

The predictive value of self-report questions in a clinical decision rule for pediatric lead poisoning screening.

PubMed

Kaplowitz, Stan A; Perlstadt, Harry; D'Onofrio, Gail; Melnick, Edward R; Baum, Carl R; Kirrane, Barbara M; Post, Lori A

2012-01-01

We derived a clinical decision rule for determining which young children need testing for lead poisoning. We developed an equation that combines lead exposure self-report questions with the child's census-block housing and socioeconomic characteristics, personal demographic characteristics, and Medicaid status. This equation better predicts elevated blood lead level (EBLL) than one using ZIP code and Medicaid status. A survey regarding potential lead exposure was administered from October 2001 to January 2003 to Michigan parents at pediatric clinics (n=3,396). These self-report survey data were linked to a statewide clinical registry of blood lead level (BLL) tests. Sensitivity and specificity were calculated and then used to estimate the cost-effectiveness of the equation. The census-block group prediction equation explained 18.1% of the variance in BLLs. Replacing block group characteristics with the self-report questions and dichotomized ZIP code risk explained only 12.6% of the variance. Adding three self-report questions to the census-block group model increased the variance explained to 19.9% and increased specificity with no loss in sensitivity in detecting EBLLs of ≥ 10 micrograms per deciliter. Relying solely on self-reports of lead exposure predicted BLL less effectively than the block group model. However, adding three of 13 self-report questions to our clinical decision rule significantly improved prediction of which children require a BLL test. Using the equation as the clinical decision rule would annually eliminate more than 7,200 unnecessary tests in Michigan and save more than $220,000.

Patient-reported outcomes of pain and physical functioning in neurofibromatosis clinical trials.

PubMed

Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Tonsgard, James H; Solomon, Sondra E; Baldwin, Andrea; Bergner, Amanda L; Walsh, Karin; Thompson, Heather L; Gardner, Kathy L; Hingtgen, Cynthia M; Schorry, Elizabeth; Dudley, William N; Franklin, Barbara

2016-08-16

Tumors and other disease complications of neurofibromatosis (NF) can cause pain and negatively affect physical functioning. To document the clinical benefit of treatment in NF trials targeting these manifestations, patient-reported outcomes (PROs) assessing pain and physical functioning should be included as study endpoints. Currently, there is no consensus on the selection and use of such measures in the NF population. This article presents the recommendations of the PRO group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration for assessing the domains of pain and physical functioning for NF clinical trials. The REiNS PRO group reviewed and rated existing PRO measures assessing pain intensity, pain interference, and physical functioning using their systematic method. Final recommendations are based primarily on 4 main criteria: patient characteristics, item content, psychometric properties, and feasibility for clinical trials. The REiNS PRO group chose the Numeric Rating Scale-11 (≥8 years) to assess pain intensity, the Pain Interference Index (6-24 years) and the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale (≥18 years) to evaluate pain interference, and the PROMIS Physical Functioning Scale to measure upper extremity function and mobility (≥5 years) for NF clinical trials. The REiNS Collaboration currently recommends these PRO measures to assess the domains of pain and physical functioning for NF clinical trials; however, further research is needed to evaluate their use in individuals with NF. A final consensus recommendation for the pain interference measure will be disseminated in a future publication based on findings from additional published research. © 2016 American Academy of Neurology.

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

PubMed

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.

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

PubMed

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.

Validity and concordance between self-reported and clinical diagnosis of hypertension among elderly residents in northeastern Brazil.

PubMed

de Menezes, Tarciana Nobre; Oliveira, Elaine Cristina Tôrres; de Sousa Fischer, Milena Abreu Tavares

2014-02-01

Self-reported information has been used as an easy and quick method to estimate the prevalence of systemic hypertension in populations. However, verification of whether self-reports of the disease are consistent with clinical diagnosis is essential for proper use of this information. This study aimed to verify the validity and concordance between self-reported and clinical diagnosis of hypertension in the elderly population of a city in northeastern Brazil. This was a cross-sectional and population-based study. The prevalence of diagnosed and self-reported hypertension and the validity and concordance between self-reported and clinical diagnosis and their distribution according to demographic and socioeconomic variables were assessed. The validity of self-reported hypertension was determined by sensitivity, specificity, and positive and negative predictive value. Overall, 795 elderly patients were evaluated (69.1% women). There was a high prevalence of hypertension among the elderly (diagnosed: 75.1%, 95% confidence interval (CI) = 71.1%-77.9%; self-reported: 59.7%, 95% CI = 56.3%-63.1%). For self-reported hypertension, sensitivity was substantial (77.1%), specificity was excellent (93.4%), positive predictive value was excellent (97.3%), and negative predictive value was moderate (57.2%). There was a moderate concordance between self-reported and clinical diagnosis of hypertension (kappa = 0.59; P < 0.001). Reasonable validity and moderate concordance of self-reported information on hypertension was observed, which reinforces the idea that this information can be used as strategy for detecting the disease prevalence in this population. However, because of nonachievement of excellence in the validity and reliability of the measured blood pressure, this information should be carefully considered for the strategic planning of health services.

Factors associated with congruence between preferred and actual place of death.

PubMed

Bell, Christina L; Somogyi-Zalud, Emese; Masaki, Kamal H

2010-03-01

Congruence between preferred and actual place of death may be an essential component in terminal care. Most patients prefer a home death, but many patients do not die in their preferred location. Specialized (physician, hospice, and palliative) home care visits may increase home deaths, but factors associated with congruence have not been systematically reviewed. This study sought to review the extent of congruence reported in the literature and examine factors that may influence congruence. In July 2009, a comprehensive literature search was performed using MEDLINE, PsychInfo, CINAHL, and Web of Science. Reference lists, related articles, and the past five years of six palliative care journals were also searched. Overall congruence rates (percentage of met preferences for all locations of death) were calculated for each study using reported data to allow cross-study comparison. Eighteen articles described 30%-91% congruence. Eight specialized home care studies reported 59%-91% congruence. A physician-led home care program reported 91% congruence. Of the 10 studies without specialized home care for all patients, seven reported 56%-71% congruence and most reported unique care programs. Of the remaining three studies without specialized home care for all patients, two reported 43%-46% congruence among hospital inpatients, and one elicited patient preference "if everything were possible," with 30% congruence. Physician support, hospice enrollment, and family support improved congruence in multiple studies. Research in this important area must consider potential sources of bias, the method of eliciting patient preference, and the absence of a single ideal place of death. (c) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Essentials and guidelines for clinical medical physics residency training programs: executive summary of AAPM Report Number 249.

PubMed

Prisciandaro, Joann I; Willis, Charles E; Burmeister, Jay W; Clarke, Geoffrey D; Das, Rupak K; Esthappan, Jacqueline; Gerbi, Bruce J; Harkness, Beth A; Patton, James A; Peck, Donald J; Pizzutiello, Robert J; Sandison, George A; White, Sharon L; Wichman, Brian D; Ibbott, Geoffrey S; Both, Stefan

2014-05-08

There is a clear need for established standards for medical physics residency training. The complexity of techniques in imaging, nuclear medicine, and radiation oncology continues to increase with each passing year. It is therefore imperative that training requirements and competencies are routinely reviewed and updated to reflect the changing environment in hospitals and clinics across the country. In 2010, the AAPM Work Group on Periodic Review of Medical Physics Residency Training was formed and charged with updating AAPM Report Number 90. This work group includes AAPM members with extensive experience in clinical, professional, and educational aspects of medical physics. The resulting report, AAPM Report Number 249, concentrates on the clinical and professional knowledge needed to function independently as a practicing medical physicist in the areas of radiation oncology, imaging, and nuclear medicine, and constitutes a revision to AAPM Report Number 90. This manuscript presents an executive summary of AAPM Report Number 249.

Essentials and guidelines for clinical medical physics residency training programs: executive summary of AAPM Report Number 249

PubMed Central

Willis, Charles E.; Burmeister, Jay W.; Clarke, Geoffrey D.; Das, Rupak K.; Esthappan, Jacqueline; Gerbi, Bruce J.; Harkness, Beth A.; Patton, James A.; Peck, Donald J.; Pizzutiello, Robert J.; Sandison, George A.; White, Sharon L.; Wichman, Brian D.; Ibbott, Geoffrey S.; Both, Stefan

2014-01-01

There is a clear need for established standards for medical physics residency training. The complexity of techniques in imaging, nuclear medicine, and radiation oncology continues to increase with each passing year. It is therefore imperative that training requirements and competencies are routinely reviewed and updated to reflect the changing environment in hospitals and clinics across the country. In 2010, the AAPM Work Group on Periodic Review of Medical Physics Residency Training was formed and charged with updating AAPM Report Number 90. This work group includes AAPM members with extensive experience in clinical, professional, and educational aspects of medical physics. The resulting report, AAPM Report Number 249, concentrates on the clinical and professional knowledge needed to function independently as a practicing medical physicist in the areas of radiation oncology, imaging, and nuclear medicine, and constitutes a revision to AAPM Report Number 90. This manuscript presents an executive summary of AAPM Report Number 249. PACS number: 87.10.‐e PMID:24892354

Instructional Development for Clinical Settings.

ERIC Educational Resources Information Center

Cranton, P. A.

Clinical teaching involves instruction in a natural health-related environment which allows students to observe and participate in the actual practice of the profession. The use of objectives, the sequence of instruction, the instructional methods and materials, and the evaluation of student performance constitute the components studied in…

Teleradiology and screening mammography: a telemammography system evaluation and comparison to clinical results

NASA Astrophysics Data System (ADS)

Leader, Joseph K.; Chough, Denise; Clearfield, Ronald J.; Ganott, Marie A.; Hakim, Christiane; Hardesty, Lara; Shindel, Betty; Sumkin, Jules H.; Drescher, John M.; Maitz, Glenn S.; Gur, David

2005-04-01

Radiologists' performance reviewing and rating breast cancer screening mammography exams using a telemammography system was evaluated and compared with the actual clinical interpretations of the same interpretations. Mammography technologists from three remote imaging sites transmitted 245 exams to a central site (radiologists), which they (the technologists) believed needed additional procedures (termed "recall"). Current exam image data and non-image data (i.e., technologist's text message, technologist's graphic marks, patient's prior report, and Computer Aided Detection (CAD) results) were transmitted to the central site and displayed on three high-resolution, portrait monitors. Seven radiologists interpreted ("recall" or "no recall") the exams using the telemammography workstation in three separate multi-mode studies. The mean telemammography recall rates ranged from 72.3% to 82.5% while the actual clinical recall rates ranged from 38.4% to 42.3% across the three studies. Mean Kappa of agreement ranged from 0.102 to 0.213 and mean percent agreement ranged from 48.7% to 57.4% across the three studies. Eighty-seven percent of the disagreement interpretations occurred when the telemammography interpretation resulted in a recommendation to recall and the clinical interpretation resulted in a recommendation not to recall. The poor agreement between the telemammography and clinical interpretations may indicate a critical dependence on images from prior screening exams rather than any text based information. The technologists were sensitive, if not specific, to the mammography features and changes that may lead to recall. Using the telemammography system the radiologists were able to reduce the recommended recalls by the technologist by approximately 25 percent.

First report of isolation and characterization of Aurantimonas altamirensis from clinical samples.

PubMed

Luong, Me-Linh; Békal, Sadjia; Vinh, Donald C; Lauzon, Dominique; Leung, Vicki; Al-Rawahi, Ghada N; Ng, Betty; Burdz, Tamara; Bernard, Kathryn

2008-07-01